SGDEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
TECHNICAL ELECTRONIC PRODUCT RADIATION
SAFETY STANDARDS COMMITTEE MEETING
THIRTIETH MEETING
Wednesday, October 1, 2003
8:30 a.m.
Food and Drug Administration
Hilton DC North/Gaithersburg
620 Perry Parkway
Gaithersburg, Maryland
PARTICIPANTS
MEMBERS
General Public
Lawrence Rothenberg, Ph.D., Chairperson
Richard Kaczmarek, Executive Secretary
Jane Benson, M.D.
James W. Platner, Ph.D., CIH
Industry
David Lambeth, Ph.D.
Michael Caswell, Ph.D.
Kimberly Kantner, BSc
Wayne Myrick, MS
Government
Kiyohiko Mabuchi, M.D.
Jill Lipoti, Ph.D.
Michele Loscocco, MS
John Cardarelli, Ph.D.
C O N T E N T S
PAGE
Greeting and Introductions
Richard Kaczmarek 4
Chairperson's Opening Remarks
Dr. Larry Rothenberg 7
Update of Informal Issues and CDRH Strategic Plan
Ms. Lillian Gill 12
Performance Standards for Sunlamp Products
Dr. Howard Cyr 31
Ms. Sharon Miller 38
Open Public Hearing
Joseph Levy 88
Joseph Schuster 98
Rick Mattoon 104
Donald Smith 108
Laura Edwards 121
Committee Discussion 123
Proposed Amendments to X-Ray Standard
Dr. Thomas Shope 176
Security Screening Systems
Dan Kassiday 229
Frank Cerra 242
Committee Discussion 252
P R O C E E D
I N G S
Greeting and Introduction
MR.
KACZMAREK: Good morning. My name is Rick Kaczmarek. I am the executive secretary for this
advisory committee.
I
am going to begin by reading a few words, a few paragraphs which describe why
we are here, the business of the committee, then, I am going to turn over the
control of the business to Dr. Larry Rothenberg, who is the chairperson.
In
accordance with the Radiation Control for Health and Safety Act of 1968, Public
Law 9602, 21 USC Subsection 360kk, the Secretary of the Department of Health
and Human Services has established the Technical Electronic Product Radiation
Safety Standards Committee for consultation on matters relating to technical
electronic product radiation safety.
As
specified by Public Law 9602, the Committee consists of 15 members including
the chairperson who are appointed by the Commissioner of Food and Drugs for
overlapping terms of four years or less.
Five
members are selected from government agencies, including State and Federal
Governments, five from affected industries, and five members from the general
public, of which at least one shall be a representative of organized labor.
Members
must be technically qualified by the training and experience in one or more
fields of science of 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 9602 and 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 industrywide 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 U.S. for any purpose
including conflict of interest determinations, however, to be consistent with
FDA's general policies regarding advisory committees, the agency believes that
a public disclosure memorandum should be made part of the public record which
identifies each member and provides their employment affiliation.
So
approved June 9, 2000, April 24, 2002, and August 1, 2003, by delegated
authority of the Commissioner of Food and Drugs, the members of the Technical
Electronic Product Radiation Safety Standards Committee are:
Dr.
Jane Benson from Johns Hopkins University School of Medicine; Dr. Francis
Gasparro from Cheshire High School in New England; Dr. James Platner, Center to
Protect Worker's Rights; The Honorable Robert Pleasure from the Center for
Working Capital; Dr. Larry Rothenberg, Memorial Sloan-Kettering Cancer Center.
The
government persons are:
Dr.
John Cardarelli from National Institute for Occupational Safety and Health; Dr.
Jill Lipoti from the New Jersey Department of Environmental Protection and
Energy; Lieutenant Commander Michele Loscocco from the U.S. Navy Joint
Readiness Clinical Advisory Board; Dr. Kiyohiko Mabuchi from the National
Cancer Institute; Dr. Maureen Murdoch Nelson from the Minnepolis VA Medical
Center.
The
industry members are:
Dr.
Michael Caswell from C.B. Fleet Company; Dr. George Kambic from Philips Medical
Systems; Kimberly Kantner from AT&T; Dr. David Lambeth from Lambeth
Systems; and Wayne Myrick from Sharp Electronics Corporation.
Now
I am going to turn over the conduct of the meeting to Dr. Rothenberg, he will
make some remarks, and then we will get underway with our first speaker.
Chairperson's Opening Remarks
DR.
ROTHENBERG: Thank you, Rick.
I
am Dr. Larry Rothenberg from Memorial Sloan-Kettering Cancer Center. I am a medical physicist working in the area
of radiology and radiation protection.
I
would like to welcome you all here for today's session. I would particularly like to thank the
members of the committee for taking time out from their busy schedules to
participate in this important activity.
I
think what I would like to do also just to orient those in the audience is
maybe, starting on my left, just have each committee member very briefly
introduce yourself and say just a sentence or two about your activities and
specialties.
So,
Dr. Lambeth, would you begin.
DR.
LAMBETH: I am David Lambeth of Lambeth
Systems. I am Professor of Electrical
and Computer Engineering at Carnegie Mellon University. My background is in physics and electrical
engineering and material science. I work a lot in the field of magnetics and
more recently in sensor systems and chemicals.
DR.
PLATNER: Good morning. My name is Jim Platner. I am with the Center to Protect Worker's
Rights, which is the research institute for the building trades unions in the
AFL-CIO. My background is in radiation
biology and toxicology at the University of Rochester, and I spent 10 years
operating Health and safety extension services at Cornell University prior to
coming to the building trades.
CDR
LOSCOCCO: I am Commander Michele
Loscocco. I have had a slight change in
rank and duty station since the notes that Rick Kaczmarek indicated.
MR.
KACZMAREK: Congratulations.
CDR
LOSCOCCO: Thank you. I am now at the National Naval Medical
Center. I am the head of the Physics
Division there. My background is
medical physics and I am boarded in diagnostic radiological physics.
DR.
CASWELL: I am Mike Caswell. I work for C.B. Fleet Company in Lynchburg,
Virginia. My background is skin
biochemistry.
DR.
BENSON: I am Jane Benson. I am a pediatric radiologist in practice for
17 years. Thirteen of those years have
been at Johns Hopkins Hospital where I am an Assistant Professor of Radiology
and Pediatrics at the Johns Hopkins School of Medicine.
DR. MABUCHI: I am Kiyo Mabuchi. I am from Radiation and Epidemiology Branch at the National
Cancer Institute. I am involved in
epidemiological studies of radiation-exposed populations including A-bomb
survivors in Japan, victims, and U.S. radiological technologies, and so forth.
DR.
LIPOTI: I am Jill Lipoti. I am the Assistant Director. I am in charge of Radiation Protection
Programs for the State of New Jersey and also release prevention, which
involves the toxic catastrophe prevention and discharge prevention containment
and countermeasures.
My
experience with radiation involves the regulation of X-ray machines, the
licensure of radiologic technologists, the certification of radon testers and
mitigators, the licensure of naturally-occurring and accelerated produced
radioactive materials, non-ionizing radiation, and with the Bureau of Nuclear
Engineering that reports to me, we respond to nuclear events and monitor around
nuclear power plants.
MS.
KANTNER: My name is Kim Kantner. I am with AT&T's Environment, Health,
and Safety Organization. I am currently
the radiation safety program officer for AT&T mostly related to occupational
and safety concerns related to both non-ionizing and ionizing source. I am nationally registered as a radiation
protection technologist, as well as a certified laser safety officer.
My
background involves compliance inspection of diagnostic machines, as well as
material licenses and familiarity with manufacturing requirements for lasers,
as well as performance standards for diagnostic and fluoroscopic units.
MR.
MYRICK: Good morning. I am Wayne Myrick. I am the national manager of product safety for Sharp
Electronics. We manufacture a large
variety of products including microwave ovens, televisions, and a series of
laser products.
My
responsibility is making sure that all our products comply with safety
standards and all the federal performance standards.
DR.
CARDARELLI: Good morning. My name is John Cardarelli. I am a commander in the U.S. Public Health
Service. I work at the National
Institute for Occupational Safety and Health.
My background is in nuclear engineering, health physics, and industrial
hygiene. For the past nine years, I was
conducting dose reconstructions in the DOE complex for occupational
epidemiologic studies.
Slightly
after that, specifically, the last three years, I have been doing health hazard
evaluations in both the ionizing and non-ionizing radiation area, as well as
primarily responsible for the radiological emergency activities for my agency.
DR.
ROTHENBERG: Thank you all very much
again for taking time out from your other activities to participate in today's
session.
We
will start the program now. Our first
speaker is Ms. Lillian Gill, who is the Senior Associate Director at CDRH. She will give us an update of informal
issues and CDRH strategic plan.
Update of Informal Issues and
CDRH Strategic Plan
MS.
GILL: Good morning. I want to welcome on behalf of Dr. Feigal,
our Center Director, and the rest of the staff, I want to welcome you to this
TEPRSSC Advisory Committee meeting. I
want to especially send our welcome to the five new committee members who are
joining us today.
We
are pleased that you have made time in your schedules to consult with us and to
advise us on our agenda items today - the performance standards for sunlamps,
our proposed amendments to the X-ray standard, and an update on a report that
we commissioned from the National Council on Radiation Protection and Measurements
on the safety of security screening systems.
Before
we hear from our staff on those issues, I want to bring you up to date on three
issues that we have presented to this committee in the past - the wireless
phones, our laser standard, and computed tomography safety.
If
you have specific questions about these three areas, we have our technical
experts in the audience this morning that will be happy to provide any answers
for you.
The
last item you see up here I have included.
My intent is to just give you some brief insight into some of the issues
that are currently under discussion in the Center as we look at the best ways
to provide protection from the public in this area, in a time when there are
significant challenges in the technology and our resources to address these
challenges are dwindling.
In
order to ensure that needed research is conducted to address the public health
concerns about the safety of wireless phones, CDRH signed a CRADA, a
Cooperative Research and Development Agreement with CTIA, the Cellular
Telecommunications and Internet Association.
FDA,
under this agreement, provides research recommendations and oversight for those
studies funded by CTIA on the health effects of radio frequency emissions from
wireless phones. To date, five studies
have been funded. In 2001, CTIA funded
three studies on research needed to address reported structural changes in
genetic material of blood cells after exposure to signals from wireless phones.
Those were the micronuclear studies.
Earlier
this year, CTIA, under the CRADA, funded two studies that are investigating the
best epidemiological tools for assessing exposure to radio frequency from
wireless phones.
Phase
III of the CRADA, which comes into effect in 2004, calls for the Center to
convene a scientific meeting to determine and define other areas of research
that are needed. We plan to do that
next year.
About
three of four years ago, FDA requested that NIEHS's National Toxicology Program
consider studying radio frequency radiation emissions from wireless
communication devices for toxicology and carcinogenicity.
NTP
evaluated all of the research efforts underway and concluded that while these
efforts have an excellent probability of producing some very high quality
research results, that additional studies were needed and are warranted to
clearly define any potential health hazards to the U.S. population. They have
agreed to conduct studies and are proposing a very large animal study.
In
addition, our own in-house staff, the Radiation Biology Branch within CDRH, is
also conducting a number of replication studies of positive findings reported
in the literature. These studies are
looking at those enzymes linked to cancer that are turned on by radio frequency.
We
do have some results of those studies, and those results have been accepted for
publication in scientific literature.
Lastly,
FDA is collaborating with other federal agencies and is a member of the Radio
Frequency Interagency Work Group. It is
a group of federal agencies that have regulatory responsibility to control the
risk from use of, and/or exposure to, radio frequency, or have responsibility
for regulation and management of the use of the RF radiation spectrum.
The
group includes the Federal Communication Commission, the National
Telecommunications and Information Administration, the National Institute for
Occupation, Safety, and Health, the Occupational Safety and Health
Administration, and the Environmental Protection Agency, and we, of course, we,
FDA, are a member of that group.
An
issue that this group has recently discussed--and, in fact, our staff is just
back from a three-day meeting--is the development of a new exposure standard
for cell phones, one that is based on biology as opposed to dosimetry. Dr. Cyr, who is in the audience, was part of
those discussions.
In
the area of laser products, for the past two sessions, I have reported on the status of our
proposed amendments to the laser standard.
We are amending the standard because of recent scientific knowledge of
laser bioeffects, at least recent in 2000 and 2001, and our desire to harmonize
FDA requirements with those of IEC.
We
have acknowledge the advantages of having one set of criteria and requirements
worldwide. Certainly the regulated
industry, the manufacturers have asked the Center to provide a least burdensome
approach to their having to meet two sets of requirements, the IEC and the FDA
requirements.
In
our 2001 guidance document, we provided conditions under which the laser
product manufacturers could introduce products into the U.S. that complied with
the IEC standards as they were amended and also listed those FDA requirements
and standards that manufacturers needed to meet in addition to IEC.
Since
the last TEPRSSC meeting, we have been in discussions with the IEC on the use
of their copyright-protected standards and with our own internal staff
particularly our Office of Chief Counsel on how we can best use these standards
to accomplish our regulatory mission.
We
are still in discussions with them and for that reason our proposals for
amendment are on hold at the current time.
Given
the past concerns about dosing from CT, at the May 2002 TEPRSSC meeting, last
year's meeting, an FDA work group suggested three technical features that could
eventually reduce by about 50 percent the radiation dose from CT scans. These three included display and reporting
of standardized indices, the CT dose, an automatic X-ray exposure control
determined by individual patient thickness, and a limitation of the X-ray field
size to reduce the amount of overbeaming in multi-slide CT systems.
After
that meeting, we discussed those considerations with a number of stakeholders,
and you can see our schedule of meeting and talking about these issues with
them. We did that both to alert them of
our thinking and to get some feedback on these ideas.
As
we weigh the potential of implementing these dose-saving features against our
resource constraints, as well as our likelihood of getting new rules developed,
our CT Work Group is considering a number of other approaches to expediting the
adoption of up-to-date standards.
For
example, we are considering a formal recognition of the IEC CT safety standard,
which is certainly encouraged under the Food and Drug Administration
Modernization Act FDAMA. Under those
FDAMA provisions, voluntary declaration of conformity of CT systems to
recognize a standard, in that case, manufacturers would not need to submit
additional information of safety aspects that are covered under the IEC standard.
FDA
could also require compliance with the IEC CT standard as a special control,
thereby giving us more enforcement control.
In this manner, FDA could make use of a more dynamically evolving
standard with control exercised through our medical device law.
Later
this month, we are participating in a joint meeting with an IEC Working Group
to further develop our plan and to work through these other approaches.
In
the last two areas that I have mentioned, you have noted FDA giving greater
consideration to the role of IEC or the consensus standards in our regulation
of products. This is certainly an
indicator to us that the FDA role in regulating radiation-emitting products is
changing.
As
you may know, we have a history of leadership in developing performance
standards, however, because our expert force over the years has dwindled from
about 400 to 60 FTEs, and we no longer have that resource capacity, we have
attempted, and we are attempting, to make adjustments in the program to find
alternative ways to get standards of safety out to the manufacturing and use
community, to address our highest priority areas, and to cover our
responsibilities under counterterrorism.
Last
year, the Center staff worked with a consulting group to focus on the direction
of the program, the content, and the resources needed to support our rad health
program.
We
looked at our definition of roles and responsibilities, our assessment of what
the future trends would be in the area, how we might best address these, and
whether or not we can use all or parts of the consensus standards that are
currently being developed to satisfy requirements for some very outdated
mandatory standards on our book.
To
complement and assess changes and expectations from some of our stakeholder
interviews that were conducted during the mid-nineties in the Center's
reengineering project, our consultants talked with a number of representatives
at the state level, some professional associations, as well as some user groups
about their perspective of the Center's future role in rad health.
Four
major themes came from those discussions.
The Center should, according to our stakeholders, either lead or
participate actively in four areas, not all areas across the products or the
issues involved, but certainly have some role based on these four issues: our quality, the assessing of quality of
product, and quality meaning our participation on implementing in the
application and the development and improvement of standards, in our assessment
of consensus versus the mandatory standards, and in the quality of
manufacturing of product.
Our
stakeholders also though that we should take a larger role in the knowledge,
management of data, that being the analysis and sharing of data associated with
product use.
We
heard a lot particularly from the states about the need for CDRH to step up our
involvement in the education and in informing of the user community on key
issues for training, as well as consumer awareness on the safety of certain
products, and finally, they thought that the Center ought to take a more active
role in assessing the emerging technology, that is, keeping track of the impact
of this technology, to address both the positive and negative impact on the
future public health environment.
With
the challenge from the Center Director to look more closely at the issues in
the medical ionizing area, our small in-house group sort or parsed the program
into the four areas you see here and identifying some of the products that we
currently are working on under those four areas. These are just examples of some of the products.
But
as you can see from these examples of the types of products in those areas,
there are some very significant issues or concerns for the Center under each,
again, with our need to look at those presenting to us the sort of highest
priority and the greatest public health issue.
While
we did have concerns in all four areas, and will look to carry out one of the
four roles for the high-priority issues under those areas, there was one that
stood out particularly more than the others, and that is the medical ionizing
area.
For
example, as the group talked about our concerns in this area, there were a
number of things that we thought putting some focused attention on would serve
us and serve the public well in the future, and I have listed a few of those
there.
Our
assessment is we are not keeping up in most of the areas with the technology,
and there is a need for us both to know what is going on in the area, know the
new design for some of these technologies, and the use, as well as some of the
training on the use for some of this product.
So,
therefore, we have as one of the recommendations to our senior staff, and we
have scheduled for the end of the month, a report on our efforts to date to
look at all four areas and to provide the Center Director with a blueprint or
some format for addressing the highest priority areas.
We
do intend to focus quite a bit of our attention in the medical ionizing area,
particularly on the quality standards for performance and use, understanding
some of the risks and benefits from this new equipment, and partnering with
manufacturers in educating users of this dose-intensive equipment.
That
is all that I am prepared to share with you on our new focus. I certainly intend to provide more at your
next meeting as we put into place some of the plans for handling some of the
new issues that will be facing us in this area.
Again, I welcome you to the meeting and look
forward to a very hearty discussion of our issues today.
Thank
you.
DR.
ROTHENBERG: Thank you very much.
At
this point, do any of the committee members have questions for Ms. Gill? Yes.
DR.
PLATNER: I just had one question. When you say you are refocusing towards
medical imaging systems, it seems to me that it is the non-medical systems that
really lack the resources on site, like health physicists and radiation and
safety officers that we see in medical and university settings, laboratory
settings.
It
seems to me that non-medical area is where people need the most guidance. I was just curious if you could comment on
that.
MS.
GILL: In our discussions, some of that
certainly was talked about, those who are currently working in those
areas. We do not plan to abandon the
needs for those areas. Certainly the
medical ionizing has the largest stake we think in the emerging technology
area, and in the others probably increasing our participation, our leadership
in the training, in the information and sharing in the training areas would
help in that area, so that we are not abandoning it at all. We will just have to focus what makes the
best use of our time to address those issues in that area.
DR.
ROTHENBERG: Dr. Lipoti.
DR.
LIPOTI: I have three questions for
you. The first one is with regard to
the Radio Frequency Interagency Work Group.
I had been familiar with the Interagency Steering Committee on Radiation
Safety Standards discourse, but this was a group that I had not realized was
formed. You mentioned that they had a
recent meeting and that it is a forum for health and regulation issues.
Are
there minutes that come out from this group?
Is there some way that we can become involved with their meetings and
their conclusions?
MS.
GILL: I am going to let Dr. Cyr who is
just back, I think it was an IEEE meeting, for which they floated the idea that
this committee will be working on, but I will let him handle those.
DR.
CYR: Yes, it was an IEEE meeting held
down in Rosslyn, Virginia. IEEE is the
group that is trying to revise the exposure standards for cell phones for radio
frequency, the safe levels. The
Interagency Group that was described met beforehand because we had some issues
with regards to this particular standard, and we attended and participated in
that meeting, listened.
Why
don't we meet afterwards, I will get your name and address, e-mails and
that. We have some small minutes from
our group, but mainly we can put you on the IEEE mailing list, and you will
receive all of their e-mails, and it's a lot of them.
DR.
LIPOTI: Thanks. Question No. 2 has to do with the CT and
reduction of CT radiation dose. I noted
that the direction which had been discussed with this group before listed
display and reporting of CT dose. Then,
when you discussed your alternative considerations based on the resources that
are available, I think that all of the items there may have discussed display
of CT dose, but have left off the reporting.
I
guess it would be important for us to know what you are losing by not going
forward with the previous direction.
MS.
GILL: I am going to let Dr. Shope
address why that one was dropped.
DR.
SHOPE: I don't know that we reached any
firm conclusions on this, but I think the idea is as the use of reference dose
levels or reference levels as are talked about in the radiological community
for providing tools to facilities to do quality assurance kinds of activities,
and if you have equipment that is capable of indicating dose, it is probably
worth considering whether that equipment ought to also assist the people
implementing quality assurance programs to be able to record and maintain those
kinds of records.
So,
I think that is where the recording has come from. Clearly, we haven't implemented requirements for recording of
dose on other equipment, although we have had those discussions here with this
committee, so I think it is an early development.
Currently,
the IEC standards for CT do have requirements for display, they don't have
requirements for recording although there are discussions underway about the
DICOM header that is used to transmit medical images back and forth and some
adaptation of those headers to include places to put dose information, so I
think there is a number of things working that we want to stay plugged into and
keep our finger on in terms of how this ought to be happening either with CT or
potentially even with other modalities, but it is very early on I think to see
how that is going to play out with the user community.
There
are a lot of issues that come up here when you start talking about recording
and how that information will later be used and where it will be end up, so I
think there are some issues that we will have to work through.
MS.
GILL: That was certainly a much better
answer than I could have provided you.
DR.
LIPOTI: The third and last
question. You mentioned that you are
focusing on medical imaging and you gave some examples, but it seemed to me
that one of the future trends is with what I would call fusion technology where
you are using not only CT, but CT PET or merging even non-ionizing MRI
modalities.
I
was wondering if the Center considers fusion technology as one of those areas
where you need to be further involved in the future.
MS.
GILL: Yes, I do remember that in our
small group discussion of where the future trends are going, and it is on the
list of those things that we really do need to track and get additional
training awareness of, so sure, it isn't excluded from the list, as well.
Any
other questions?
DR.
ROTHENBERG: I just had one comment with
regard to the CT dose question and the recording of it. I think certainly this is one area that we
should certainly stay strongly plugged into because this is one of the
modalities where, as you mentioned with the Dicom Headers, and so on, where it
would be most possible to keep track of this type of thing, whereas, with other
areas, some of the interventional units
and so on, it seems to be most of the systems are set up, so that there is some
kind of dose display and then it disappears when the next patient comes in.
I
know we will hear some more about things related to the fluoroscopy standard
later this afternoon, so I don't want to pursue that now, but just a comment.
Anyone
else have questions? Yes, Dr.
Cardarelli.
DR.
CARDARELLI: I just wanted to briefly
follow up on the comment that Dr. Platner had earlier about the emphasis on
medical versus non-medical technology and whether research funds I guess will
be directed to.
One
thing I would like to at least point out is if a decision goes that way, if it
could be clearly publicized on the public health basis. A number of people in the United States are
affected by that particular technology.
I
would think that the general public, the non-medical folks, the people who are
not receiving medical treatment, those numbers are huge out there compared to
those that are being exposed to the medical technology, however, their doses
are probably very low, you know, relatively speaking.
I
just wanted to put that point out there to clearly communicate the basis from a
public health perspective of why our dollars are being shifted or emphasized in
one area.
MS.
GILL: Thank you. We will certainly do that.
DR.
ROTHENBERG: Thank you very much, Ms.
Gill. I know you have other engagements
this morning.
MR.
KACZMAREK: I think we can go ahead if
there is no other questions from the committee with the first speaker.
DR.
ROTHENBERG: Our next presentation will
be on Performance Standards for Sunlamp Products. Dr. Howard Cyr and Sharon Miller have prepared that.
Performance Standards for Sunlamp
Products
DR.
CYR: I am Howard Cyr. I am the Acting Branch Chief of the
Radiation Biology Branch. I have been
the person for the last few years, I guess at least four years, who have come
before you and been the one to brief you on the progress of our work toward
amending the performance standard for sunlamp products.
However,
this year, Sharon Miller is going to be the key person and she will present our
ongoing program of research that we hope leads to some regulatory changes.
I
am here to brief you on the work that I have done in the last few years and to
tell you a little bit about the work that is still left for Sharon to do.
Over
the last four years, we have been pursuing new amendments for at least three
reasons, one of which is that the science of photobiology is telling us that
some of our regulations are a bit outdated particularly in terms of dosimetric
considerations and that we should be making some changes and incorporating
these changes into our rules and regulations and recommendations.
There
has also been a move toward harmonization and it means that we in the United
States should be making changes to facilitate international trade and some of
the regulations need changes to put them in sync with those of the
international community. Sharon will
tell you about these efforts particularly our work with the International
Electrical Technical Commission, the international agency that writes these
standards.
There
has also been research done suggesting connection between sunlamps and
melanoma, some very controversial research, and I will describe that a little
bit.
Each
year we have met with you and you have given us advice. Some of it was that we were somewhat
premature when we first gave our suggested amendments particularly with regards
to recommended exposure sessions.
You
told us that we probably should go back and do some research on skin types and
the doses that were needed to produce tans, that we weren't really ready at
that time to come up with the exact recommendations that we were proposing.
You
have also told us that we should go back and spend more time with the various
parties, the interested groups who have a stake in these regulations, both the
indoor tanning industry and the dermatology community, and have done both of
those.
What
we originally thought was going to be a simple process of revision has actually
turned into a multi-year effort, and we are still ongoing.
Since
we began four years ago, I would like to go into some of the new scientific
happenings and projects that have taken place.
As
I mentioned, we in the Center have started research projects. One of those is on how to measure changes in
the skin and now Sharon Miller has a second project on skin types and the
amount of dose that it takes to produce the tan and to keep a tan, and she will
describe those.
There
have also been elsewhere efforts, new risk assessment efforts particularly done
by the National Toxicology Program in North Carolina. They put out reports on carcinogens, the Ninth Report and the
Tenth Report, in which they actually named sunlamps as a known cause of
cancer. This finding and this
conclusion is somewhat at odds with the conclusions of some epidemiologists and
also the International Agency for Cancer Research which doesn't go quite that
strongly. They conclude that sunlamps
are a probably cause, not a known cause, so there has been some controversy on
the melanoma/sunlamp association.
There
has actually been new data in the last few years, a couple years, on this
connection. A group in Sweden headed by
Wester, et al., has done another larger study, and they conclude that the
connection between sunlamps and melanoma is even stronger than they had previously
reported.
On
the other hand, there is a group headed by Ultiay [ph] who did a study
previously and said there was an association.
He has now done a larger study, and is only I believe in abstract form
and presented at a meeting, it is not in final publication, but he now says
that the association is not there. So,
melanoma/sunlamp connection is truly complicated and still remains highly
controversial.
There
has been a new initiative particularly on the part of the indoor tanning
industry to emphasize the benefits of UV in connection with production of
vitamin D, and I would like to point out to you that there is going to be a
major conference next week, Thursday and Friday, at the National Institutes of
Health on the risk and benefits of UV exposure in connection actually more on
vitamin D, the UV association will be part of that conference, and we plan on
attending and participating.
We
have also had recent interactions with the Academy of Dermatology and tried to
bring to a focus our various ways of protecting the public from the risk of UV
interactions, and we are continuing those interactions. I believe a representative from the Academy
is here today and probably will speak later on. I haven't seen her yet, but I think she will show up.
I
am saying all of these things to highlight to you the complexities of the
problem we have here at FDA. We are
quite literally caught between two opposing viewpoints on UV risk.
On
the one hand, we have got the dermatology community which has been telling us
that any exposure is risky and could lead to serious health effects. In fact, a few years ago, they have asked us
to ban sunlamps.
More
recently, we actually within the last month, we have received another letter
from an individual dermatologist, not from the Academy, but an individual
dermatologist who again in a letter to the Commissioner has asked us to ban
sunlamps. We are still preparing a
response to his request.
On
the other hand, the indoor tanning industry feels that moderate doses are, in
fact, safe and are even beneficial in the fact that they can produce vitamin D,
and there are epidemiology studies to show that in areas where you have high
ultraviolet radiation, you, in fact, have lower cancer risk for certain other
kinds of cancers.
They
are making the association that vitamin D prevents cancers and that, in fact,
there are some beneficial effects from moderate UV exposures, and they have had
a somewhat of a small lobbying effort to have us, in fact, allow them to put
claims for benefits on UV lamps.
So,
there are complex scientific issues.
What we thought would at this time, we would hope a finished product, we
would have our recommendations in to you and we would be done, has actually
turned out to be an intense debate. I
think the level of debate and the seriousness of the issues are probably now at
an all-time high.
But
the main reason I am addressing you today is to tell you that unfortunately, I
am no longer the lead person in this sunlamp issue. I am still very much interested in the area, but I have been
assigned to new projects.
A
key person in our branch left us more than a year and a half ago, he was our
branch chief. I volunteered to be a
temporary branch chief until such time as we could find a new one. I am now the branch chief for some 16
months, and I don't see any sign that we are going to get a new branch chief,
so I have had that job and probably will have it for at least a few more months
here.
Also,
this person was in charge of our CRADA, the Cooperative Agreement that we had
with the telecommunications industry involving cell phones, and I took over
that project, too. So, as much as I
would like to stay involved in sunlamps, I am staying involved, I just don't
have the time to be the lead person, and I asked Sharon Miller to take over
that job for me.
Sharon
is extremely qualified to do this. She
is actively involved in the research project.
Like I said, she has a project starting on the doses that are required
to obtain and maintain a tan in an effort to perhaps say that one could use
less dose than we are presently using to get a tan.
Sharon
is an engineer, she understands the dosimetry of these lamps and the
classification schemes that she is going to propose. She is a member of this International Electrical Technical
Commission and she knows the national and international standards and the
recommendations related to sunlamps.
So,
as I say, as much as I would like to stay in this area, I must give this
responsibility to Sharon, and she will now be the lead person. I will be available for consults, but for
now Sharon will be your contact person and will be the one who will present our
program of research and the interactions with the international agencies and
our continued effort toward modernizing our regulations and recommendations.
At
this time, I turn the proceedings over to Sharon Miller. Thank you.
MS.
MILLER: Thank you, Howard.
As
Howard was saying, as he has moved on to new challenges, I have inherited this
job of presenting our proposals to you.
Today, I would like to propose six amendments to our performance
standard for sunlamps.
Some
of them you have seen before and a few of those have been adjusted slightly in
order to either improve harmonization with international standard or to take
care of some minor technical problems that we have discovered in the past year.
I
will give you a brief history for the benefit of the members who are new to the
committee and for some of the other people in the audience who might not be
quite up to speed with what has happened since we first decided to make
amendments to our performance standard.
Back
in 1998, we did publish an Advanced Notice of Proposed Rulemaking, which I will
refer to as the ANPRM. As Howard
mentioned, some of the reasons we did this were because there were concerns
about melanoma being related to sunlamp use, also, that there was a melanoma
epidemic occurring in this country and also other countries.
The
AMA sent us a petition to ban sunlamps and, in addition, we received a
citizen's petition to increase the enforcement of sunlamp products. Also, as mentioned, we would like to
harmonize as much as possible with the international standard for sunlamp
products.
Lastly,
the technology of the sunlamp industry and our knowledge base have changed
since 1985 when our last iteration of the standard was published. I just noted that the original standard was
published in 1979.
Now,
I am going to tell you what the proposals were that we did publish in the ANPRM
in 1998. The first was to update our
recommended exposure schedules. At that
time, we were really seeking input from the experts on how we could improve the
exposure schedules that we had provided guidance to manufacturers in a policy
letter that was published in 1986.
At
the TEPRSSC meeting, I think it was two or three years ago, we talked about
this, and the committee actually advised us to do research and develop
scientifically-based exposure schedules, so that is what this current research
that Howard mentioned that I am doing is addressing this.
We
are doing a human study right now that is about halfway finished. We are looking at trying to come up with
guidance for exposure schedules that can produce tans, but significantly lower
the dose. So far the research is very
promising. It looks like we can reduce
the cumulative dose by about a factor of 4.
If you have any other questions on that, I can give you more details
later.
Another
thing we wanted to do was, as I mentioned, this guidance for the exposure
schedules was in a policy letter, it wasn't in the actual standard in the 21
CFR document, so we wanted to make the recommended exposure schedule part of
the standard to increase the enforceability of that. That is something that we would like to do after we finish
fine-tuning these recommendations.
The
third item was that we wanted to clarify what the definition of
"manufacturer" was. By that,
we mean that the manufacturer would include things like making significant
modifications of a sunlamp product.
That is something that is also already in our laser standard.
Next,
we wanted to update he warning label mainly to make it more succinct and easier
to read, and also to require that this warning label be reproduced in catalogs
and advertising literature, so that people who, for instance, bought the
products for home use would see the warning label and know what types of risks
they were being exposed to before they got the product home.
Lastly,
we wanted to develop a uniform rating scale for replacement lamps because as
lamps in these sunlamp products age and need to be replaced, it has become very
difficult for salon owners to know which lamps are suitable, because we want to
have a biologically equivalent lamp put in that product, so that the timer
setting will not be made, you know, you don't want to burn people.
So,
it was to simplify the tasks of salon owners and also inspectors, because when
both FDA inspectors and state inspectors go into salons, one of the things they
look for is whether or not the right lamp is in the product. It is such a complex system, it is almost
like a telephone book or similar to the catalogs you find at auto part stores
when you are looking at cross-referencing your bed or the original lamp and
what the new lamp model number is. It
is very confusing for people.
Also,
we wanted to increase safety as I mentioned. We want to avoid people getting
burned from the wrong lamp being put in the product. Actually, we sponsored two meetings at FDA about this issue since
1998, and we have made a lot of progress, so that is one of the things we will
be talking about later.
More
recently, last year at the TEPRSSC meeting, we only presented four proposals
that we felt we were ready to go with at that time. It was the simplified warning label, the requirement that the
label be reproduced in advertising literature, redefining what a manufacturer
is, and we also wanted to revise the specifications for eyewear because the
current definitions are not quantitative and we wanted to improve that.
At
that meeting, you gave us a tentative go-ahead on all but the third proposal,
and the third proposal was the one reference to what a manufacturer is. I believe you thought that that needed a
little bit more work on making it clear exactly what kind of modifications we
were talking about.
When
you gave the go-ahead, you did understand that there would be a 90- to 120-day
comment period after the official proposed rule is published and that at that
time, FDA is required to address every comment. So, if there were some major technological why our
recommendations were not prudent, we would have to address that at that time.
I
just also wanted to add that proposals 1, 3, and 4 have been fine-tuned or
slightly modified since the last meeting partly in order to better harmonize
with IEC.
Also,
some of the things Howard mentioned, there have been two meetings of the IEC
Committee. I attended and also Dr. Beer
who is here today, who is a biologist and an expert in this area. We have been very active in introducing new
changes to the IEC standard. We feel we
have come a long way towards harmonizing our standard with their standard. I will go over some of the highlights of
those meetings in the next slide.
Lastly,
the end of June, we met with the American Academy of Dermatology and also the
American Society for Photobiology to discuss some of their concerns about our
regulations and our research.
Just
to tell you a little bit about what happened at the October IEC meeting, the
things that were discussed was, first of all, the incorporation of a new action
spectrum, which is basically a function that you use to determine what the
relative effectiveness is of different wavelengths of a sunlamp, at least in
this case a sunlamp.
They
decided to go ahead and approve the use of a new action spectrum, which is for
non-melanoma. This has just recently,
or I would say maybe a couple of years ago, been adopted by the CIE
organization.
The
IEC has now decided to also use it in their standard in addition to the
erythema action spectrum, which is for sunburn.
The
other item we talked about was changing the classification. There were previously four types of
products, and they are classified according to the balance of UVB and UVA
radiation that they emit. An additional
type was added in order to include products that had previously been excluded
from this list.
An
important item that was discussed was an absolute cap on how much irradiance
the sunlamp product can emit. It was
voted on and accepted that this level of 1 W/cm2 weighted with the
non-melanoma action spectrum would be the limit that beds could emit. Just to give you an idea, this limit is
about 2 times the intensity of tropical sun.
Lastly,
we were still working on the details of replacement lamps. What we decided to do, in the International
Committee, it is a little bit more complicated because the committee that we
normally work with, the IEC TC 61, has responsibility for the sunlamp product
and the bed or the booth.
Yet,
there is another committee, that is, TC 34, that has responsibility for the
single fluorescent lamps and how they are measured. So, we had to work out a system where we could liaison with this
committee and try to get their help on coming up with an acceptable measurement
scheme and coding scheme. At this
meeting, we decided to create a liaison with them.
Then,
in June, one of the things we talked about was modifying the instructions for
use. One of the things that was changed
here was including limiting the use of products by minors.
The
thing that probably took the most time was the replacement lamp issue. Members
of this other committee that I told you about actually attended and they
presented a scheme for measurement and coding, and we reached a compromise on
how to do that. That is the scheme I
will be presenting today.
Just
briefly, the meeting we had with the American Academy of Dermatology, we told
them about our research and the regulations of sunlamps, and they told us about
their concerns, which were, one, that they were seeing an increased use of
sunlamp products over the last few decades especially among young women and
even children, and they are also seeing increased rates of skin cancer among
Americans, so they are very concerned that we should try to strengthen our
warnings and regulations as much as possible.
At
that meeting, they told us they had plans to send petitions to the FDA
Commissioner to this effect.
Now
I am going to go through the six proposed amendments. As I said, some of them have been presented before and I will
just repeat them, so that we can make sure that you understand what we are
presenting now.
The
Proposed Amendment 1 is to change the warning label. This is a reproduction of the current label which you can see is very wordy and it is not very
ergonomic, so we wanted to improve that.
This
is the Proposed Revised Label. It is
basically what is in the international standard. It just says, "Warning - Ultraviolet radiation may cause
injury to the eyes and skin, skin aging, and skin cancer."
"Read
instructions carefully. Wear protective
eyewear provided. Certain medicines and
cosmetics may increase sensitivity to ultraviolet radiation."
This
last part that is in pink is something that some people at the Agency would
like to see added to the FDA label.
This is currently not in the IEC standard, but there are certain
deviations that we are allowed to make with that label. We would probably like to get your opinion
on whether or not that is a good idea to add that or not.
We
also will have requirements on the size of the lettering, so that it is clearly
legible.
Proposed
Amendment 2 is just including the warning label on catalogs and, as I said,
this is consistent with requirements already in the laser standard.
Proposed
Amendment 3 is the definition of "manufacturer." This also is consistent with requirements we
have in the laser standard.
This
would be the language that would appear in the standard, and it reads: "The modification of a sunlamp product,
previously certified under Section 1010.2 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 on intended function for which this section has an
applicable requirement. The person who
performs such modification shall recertify and re-identify that product in
accordance with the provisions of Sections 1010.2 and 1010.3."
Just
to clarify, things that we would consider to be significant modification would
be the following: Replacing original
lamps with lamps that are incompatible. Increasing the maximum timer setting
beyond what it originally was set at, and something like removing required
labeling or replacing original labeling with a labeling that would render the
product noncompliant.
Proposed
Amendment 4 deals with eyewear. The
current language in the standard reads like this: "The spectral transmittance shall not exceed a value of
0.001 over basically the UVB range, actually, a little bit lower than UVB, 200
to 320, and a value of 0.01 over the UVA range of 320 to 400 nanometers, and
shall be sufficient over the wavelength range greater than 400 nanometers to
enable to user to see clearly enough to reset the timer."
It
is this part that we want to improve, because it is not quantitative and there
is really no way to test that in an objective manner.
So,
we could keep the UV limits the same, but for the visible region, we would like
to propose a more quantitative definition, and that is that the luminous
transmittance shall not be less than 1 percent over the 380 to 780 nanometer
wavelength region.
We
have suggested this to IEC and it has now been adopted in the IEC standard.
Just
to give you an idea of what the luminous transmittance is, here is the
formula. It is a little complicated,
but it is really based on the amount of light that the eye can perceive.
So,
the quantities which are spectral functions in this formula, the Y(lambda) is
the relative luminous efficiency of the human eye, and then you also need to
use a standard light source in order to do the calculations, and you include
the spectral transmittance of the eyewear to get a number for the luminous
transmittance.
We
are proposing that a floor of 1 percent be the cutoff point for this value.
In
addition, we don't want too much visible light to be transmitted because there
is a chance, especially in sunbeds that have high-pressure lamps which are very
small lamps of high intensity, there is a chance for damage to the retina from
visible light. So, we want to institute
a cap of 5 percent on the unweighted spectral transmittance from 400 to 550
nanometers. This requirement is also
part of the international standard and has been in there for several years.
However,
we have had our FDA laboratory in Winchester, Massachusetts, do testing on
eyewear recently and we found out that there is some eyewear currently on the
market that cannot meet the 5 percent cap.
It is not a large percentage of the market, but there are some products
that can't.
So,
since it is really only a hazard when you are using it with a high-pressure
lamp, we are proposing that these products that can't meet the cap be required
to bear a tag reading something like the following: "Does not provide adequate eye protection in sunlamp
products with high-pressure lamps in the facial area."
In
addition, it is a requirement in the standard that two pairs or however many
people that you think might be using the product, that number of pairs of
eyewear must be sold with the product.
So, high-pressure lamps, some of their products could not include this
type of eyewear that doesn't meet the 5 percent cap with their product.
As
I said, the rationale is because the high-pressure lamps are more likely to be
pose a hazard than the fluorescent lamps are.
Proposed
Amendment 5. I am breaking this into
two parts, A and B. They really go
together. We would like to change the
action spectrum that we are currently using.
Right now we are using something called the CIELYTLE erythema action
spectrum.
At
the time we published our standard, there was no standard, no internationally
accepted action spectrum for erythema or sunburn. So, what certain people at the Agency did was take the data that
was in the literature and adjust it, and used that as the action spectrum.
But
now there is an internationally accepted spectrum, it has been well tested and
it is used by many organizations. FDA
uses it in their Sunscreen Monograph.
It us used by the National Weather Service, who define the UV index,
and, of course, it is also used in the IEC standard.
So,
we would like to update our standard in that way and change to using what is
now the CIE reference action spectrum for erythema.
Here
is a plot of the two spectra. They look
very similar especially on this plot, which is a log plot here, but there are
slight differences in this region, and this region, but they are not
significant, but we feel it would be an improvement to incorporate the standard
that is more internationally accepted.
Part
5B is to not only change the action spectrum that we use, but to also change
the value of Minimal Erythema Dose that is used in defining the timer, and it
is also used in setting the exposure schedule.
FDA
is currently using a value of 156 joules per meter squared. Since the time when we published our
standard, a lot of research has been done, and there is a CIE standard in
progress that is going to recommend 200 J/m2 be used as the minimum
erythema dose for a skin type 2 person, which is the person with high
sensitivity that would be expected to use a sunlamp product.
This
is a weighted dose. This dose is
supposed to be determined with weighting the output of the lamp with the
erythema action spectrum.
In
the FDA standard, the Maximum Timer Limit is currently 4 MEDs, where the MED is
156. So, in order to maintain the same
biological dose in our standard, we are proposing using 3 MEDs now, which is
approximately still 600 J/m2 effective dose.
The
last amendment deals with replacement lamps. As I said, the current situation,
which is defined in a policy letter, relies on a relative comparison between
two lamps. In order to be considered
compatible, these two individual lamps must be within plus or minus 10 percent
of both erythemal and melanogenic or tanning effectiveness in order to be
considered compatible.
That
system is not very desirable and we would like to have an absolute system that
can be tested by independent laboratories, as well as a lamp code on the lamp,
so that people could immediately see if it's the right lamp that is in the
product or not.
Just
to give you an idea of this is an example of a lamp. This person's face has been blotted out to protect her
identity. Here is the number that we
will be modifying or we hope to modify to use for UV coding.
It
says right now 62W-R. What that means
is 62 watts and R implies that it is a reflector lamp, as many lamps today have
reflectors built into them. This text
down here just tells you what is written on the lamp.
What
is being proposed now is we have a code that consists of wattage, reflector
code, and then a UV code. Of course,
the wattage is just the nominal lamp wattage marked watts or W. The reflector code is one of these following
letters, either O for non-reflector lamps meaning open, B for lamps with broad
reflector angle, N for narrow, R for regular, and these are defined by an angle
alpha that refers to the angle of open surface area in the lamp.
Lastly,
the UV code consists of two numbers. We
are calling them X and Y where X is the total erythemal-effective irradiance
from 250 to 400 nm, and Y, we need to use the NMSC action spectrum to determine
Y. It is actually a ratio of the NMSC
effect of irradiance from 250 to 320 over 320 to 400.
The
reason we are including this action spectrum in the lamp code is because as I
mentioned before, the IEC standard requires that sunlamp products be classified
in one of four classes, or five classes now, based on what their balance of UVB
and UVA is, and in order to ensure that when you replace the lamp, you don't
end up putting it at a different class, it is necessary to have this kind of
ratio information be on the lamp, as well.
The IEC standard is using this action spectrum to classify products.
So,
in addition to coming up with the coding scheme, we also had to develop
standard operating procedures for lamp measurements, and this has been worked
on by a lot of lamp manufacturers.
There
is an existing standard out there, that is an IEC standard called the Method of
Measuring and Specifying Fluorescent Ultraviolet Lamps used for Tanning.
However, this standard will be modified in the near future based on the results
of this working group that met with us at our last IEC meeting because it
needed to be updated.
It
had been written based on making a measurement of total flux which is a method
that not many people are using, so they are going to refine that and base it on
an irradiance measurement. These are
the lamps the lighting engineers are mostly going to be working on.
So,
the readings that will constitute part of the code will be based on an
irradiance measurement from a single lamp, and it shall either be measured at a
distance of 25 cm from the center of the lamp, or if a manufacturer chooses to
measure at a distance other than 25 cm, he must correct his measurement value
to what it would be at 25 cm. That is possible to do either mathematically or
just by simply making a correction factor with simple measurements.
Just
to show you what the non-melanoma skin cancer action spectrum looks you, it is
shown in pink here, and comparing it to the erythema action spectrum, which is
simplified for mathematical purposes because in the days when it was first
developed, spreadsheets were not very common, so they made it into a curve with
three different slopes.
But
anyway, this non-melanoma skin cancer action spectrum has been developed in
mice. It was developed by research in
labs both in the U.S. and in Holland, and it is now an accepted international
standard in the CIE Standards Committee
The
tolerances that we would like to see on this UV code, similar to what we have
been accepting up until now, we would like to see a plus or minus 10 percent
limit on these numbers.
Therefore,
as an example, if the original lamp in the sunbed had the code of 100 watts, R
reflector type, and then 47 where this was the X number and 3.2 was the Y
number, which as you remember is a ratio, suitable replacements would be as
follows:
The
same numbers here and then this number could range from 42 to 52, this number
could range from 2.3 to 3.8, and this is more than 10 percent, but that is
because when you take the ratio of two numbers, those two numbers can deviate
by 10 percent, it ends up being a 20 percent allowable deviation in the ratio.
We
see that on the sunlamp product itself, there will be a label that would say
something like use only lamps with these ratings, and these are examples of
suitable replacements for that product.
We
probably will have some future proposals.
This standards amendment process is a very long process. We have already published an ANPRM. The next step would be to publish a Notice
of Proposed Rulemaking, but before we can do that, a lot of things have to
happen - an economic impact analysis has to be done, other types of analysis, I
believe it is called the Regulatory Flexibility Act has to be done to see if we
have looked at all alternatives, and it will take probably three to four years.
But,
anyway, in that time, we anticipate finishing our study, so we believe we will
have recommendations for the revised exposure schedules before we go to the
proposed rule stage. If there any
additional changes instituted by the International IEC Committee, that also may
result in a few new proposals.
So,
after you hear comments from people in the audience, I would like to request a
vote from the committee on the six proposals that I presented. If you have any other questions, I can take
them now or take them later.
Thank
you.
DR.
ROTHENBERG: Yes, at this time, we
should have any questions about the presentation as opposed to consideration of
the amendments. We will have following
this presentation and a break, the open public hearing. At this time, if there are any questions for
Sharon Miller about the technical aspects or definitions, anything related to
the presentation. Yes, Michele.
CDR
LOSCOCCO: I guess I had two
questions. One, I remember there being
I guess very specific questions about the responsibility of the manufacturer
regarding the lamp replacement.
So,
you think that the new information that would be required, you alluded to like
a manual like you would replace your light bulb in your car, is that the type
of thing--
MS.
MILLER: That is what is being used
currently is the manual kind of system.
CDR
LOSCOCCO: So, you think that would simplify
it by having these?
MS.
MILLER: Oh, yes, definitely. I mean that is what we hope. What happens now is that the manufacturers
of individual lamps submit what they call a compatibility declaration sheet,
and it is a very long list saying, you know, if you have lamp, you know,
beautiful tan, 23567, you can use one of these 10 lamps as replacement lamps.
Then,
there is a long list for all the lamps they manufacture. Like I said, we foresee that there would be
a clear label on the bed saying use only lamps of this type, and then that code
would be on the lamp, so it will be more universal. You wouldn't have to use only that manufacturer's lamp.
CDR
LOSCOCCO: I guess the concern was not
necessarily for the larger tanning bed salons, but the person that has one in
their house. Is the person that then is
the homeowner that is replacing their lamp then considered the manufacturer,
because they are replacing a lamp?
MS.
MILLER: No, no, and if anybody replaces
a lamp with an acceptable lamp, they are not required to report to us or
consider to be a manufacturer for that purpose. So, as long as they use the right lamp, it is not a problem. Of course, a homeowner would not be
considered because they are not exposing the general public. Thank you.
DR.
ROTHENBERG: Dr. Cardarelli.
DR.
CARDARELLI: Two quick questions. One, I do like the simplicity of the new
label. The one question I had, though,
is the change from the word "Danger" to "Warning" in that
it does breed a little bit of inconsistency with that, that the manufacturers
put on the bulb, the bulb itself or the lamp itself has the word
"Danger" on it.
So,
in terms of communication to everyone out there in the world using these, it
would be good to have some level of consistency. I don't know if the word "Warning" is consistent with
the international.
MS.
MILLER: That got changed a few years
ago, I can't remember exactly what the reasons were that we decided to go from
"Warning" to "Danger."
Do you remember, Howard?
DR.
CYR: It was a question of harmonizing.
MS.
MILLER: I wasn't sure if it was a
conscious decision that it was not as much of a hazard as we thought it was.
DR.
CARDARELLI: At least then for the
manufacturers, you may want to maintain some level of consistency.
MS.
MILLER: On the lamp, whatever you are
going to have, have on back, too.
DR.
CARDARELLI: The other question I had
was, what was the basis for the 10 percent compatibility rule?
MS.
MILLER: Well, it was I guess more to be
in agreement with what is achievable in production and to try to build in as
much safety as possible.
DR.
CARDARELLI: So, even if they were 10
percent over, set at the maximum time, it won't result in some sensitive person
getting burned.
MS.
MILLER: Most likely not. From the research we have seen, you really
have to usually go at least 20 percent over to see a difference in reaction.
DR.
CARDARELLI: Thank you.
DR.
ROTHENBERG: Dr. Lambeth.
DR.
LAMBETH: I wonder if you could shed
some light on the aspect of the spectral changes in the lamp with
lifetime. Is this more than 10 percent,
does it fall within that same sort of category?
MS.
MILLER: Definitely.
DR.
LAMBETH: Pardon?
MS.
MILLER: Yes, over the lifetime, I mean
I can't say "lifetime" because--maybe someone from the audience would
like to speak about this, someone who has day-to-day experience with it--but I
know that before the lamp has totally failed, they can easily drop by half, if
not more in their output, in the effective output.
DR.
LAMBETH: I wasn't so concerned about
the wattage as I was about their spectral content.
MS.
MILLER: Well, I believe what happens
normally is that the shorter wavelength spectrum drops quicker than the longer
wavelength spectrum. In any event, they
are getting less powerful, their sunburning potential is going down with life,
with time.
DR.
LAMBETH: So, would a salon operator
change this when it is down by 50 percent, or is it down by 10 percent?
MS.
MILLER: You had better ask the salon
owners here, they could tell you that.
DR.
ROTHENBERG: Dr. Caswell has a question.
DR.
CASWELL: Sharon, just a
clarification. Do I understand that you
want to use the CIE erythema action spectrum for 5A and then the non-melanoma
skin cancer action spectrum for Proposed Amendment 6?
MS.
MILLER: Amendment 6, which is the lamp
rating, you use both, both erythema and the non-melanoma skin cancer. The first number is the total
erythema-weighted output, which used the CIE erythema action spectrum.
DR.
CASWELL: The X value.
MS.
MILLER: The X value, right, and then
the Y value is based on the non-melanoma.
DR.
CASWELL: Why would you use both of
those, what is the thinking behind that?
MS.
MILLER: Well, we want to use the
erythema action spectrum because we feel as long as we keep the lamps within
the limits of that value, we can prevent people getting burned, whereas, if you
only use the non-melanoma skin cancer action spectrum, there is a slight
chance--you know, there isn't a huge difference in the two, but there is a
slight chance that you might have a lamp that agrees with the non-melanoma skin
cancer action spectrum number, but doesn't agree on the erythema number and
someone could get burned.
As
I mentioned before, the reason we want to use the non-melanoma number in
addition to the erythema number, is to allow that the IUC Classification System
is preserved, because they classify their sunlamp products, the sunbeds, based
on non-melanoma skin cancer-weighted output in the UVB and UVA.
So,
it is really just to make sure that, like I said, we don't have lamps being
changed and have the product accidentally go into a different class.
DR.
ROTHENBERG: I have just one question
about the wattage. Is it specified
somewhere that only the same wattage bulb, because you don't address the
wattage itself?
MS.
MILLER: Yes, well, that is part of the
code, so the first number that was shown there was--either on the lamp I
showed--it was 62 watts, so, yes, you would have to use lamps of the same
wattage, same reflector type, and same UV code, or UV code within 10 percent.
Dr.
Lipoti.
DR.
LIPOTI: I have got four questions. The first one has to do with the warning
label also. Based on the classification
of skin cancer as a known cause of cancer, the label says ultraviolet radiation
may cause skin cancer. I wondered if you needed to take into consideration the
work of the Toxicology Institute.
MS.
MILLER: Well, the reason we prefer to
have "may" on there is because not every person who is exposed to UV
either from tanning lamps or from the sun will get skin cancer. So, it is not a definite given and
conclusion.
I
mean ultraviolet radiation can cause cancer, it doesn't always cause cancer in
an individual.
DR.
LIPOTI: The second question has to do
with timer accuracy. Is there a
standard for timer accuracy?
MS.
MILLER: Not currently, but I believe it
will come out of--
PARTICIPANT: [Inaudible comment.]
MS.
MILLER: Well, that may be what the
industry standard is, but it is not really written in the FDA standard, but I
think when we have the standard operating procedures for lamp measurements,
there will be accuracy requirements on that.
That will in effect lead to accuracy requirements on the timer value.
DR.
LIPOTI: But your measurement procedure
is not part of a regulation. Wouldn't
timer accuracy be an important thing to put in the regulation?
MS.
MILLER: Well, if we accept the IEC
measurement standard or recognize it as part of our standard, then, it would in
effect become part of our standard.
DR.
LIPOTI: It would be enforceable.
MS.
MILLER: Yes.
DR.
LIPOTI: On Proposed Amendment 5, you
seem unconcerned with the deviation between the current standard of 4 minimal
erythema dose units, which comes out to 624 joules per meter squared, versus
the new standard, which would be 600.
That
deviation, what is the uncertainty in making these kinds of measurements, and
why are you unconcerned with that deviation?
MS.
MILLER: Well, there is two
reasons. There is quite a bit of
uncertainty in making these measurements. Measurements of ultraviolet radiation
are difficult to make in an accurate manner.
Probably most very experienced laboratories could do it best, say, 15
percent accuracy.
Another
reason we are not too concerned about this difference of 600 to 624 is because
there is a difference in the action spectrum, and depending on the lamp
spectra, that will slightly change the resulting effect of dose that you get.
So,
between the weighting function being a little different and the accuracy being
less than 10 percent, it is really about the same. You are talking about apples to apples there.
DR.
LIPOTI: The last question. This was not on your slide. You mentioned that it was three to four
years is your time line for writing a standard.
MS.
MILLER: Not for writing it, but for
getting it in a final published, enforceable form.
DR.
LIPOTI: So, that includes--you have
already done Advanced Notice of Proposed Rulemaking, so you must do the
proposal, respond to comments, and finalize it.
MS.
MILLER: Yes.
DR.
LIPOTI: And that takes three to four
years?
MS.
MILLER: Well, before we get to the
proposed rule stage--and maybe someone else in the audience would be better to
explain this in detail--but we need to do a lot of different notifications--not
notifications--but we have to do economic impact analysis. That is a pretty lengthy procedure. I believe it has to be approved by General
Counsel. There is just a lot of
bureaucracy that has to be taken care of before it gets to the proposed rule
stage.
DR.
ROTHENBERG: Dr. Cardarelli.
DR.
CARDARELLI: I have one follow-up
question. If I heard you correctly in
your presentation, you suggested that some research that you are conducting may
result in a reduction in the exposure schedule.
MS.
MILLER: In what was that?
DR.
CARDARELLI: The amount of time it takes
to get a tan and keep a tan.
MS.
MILLER: Yes.
DR.
CARDARELLI: Now, if that is the case
and FDA comes out with some recommendation that says the exposure schedules can
now be reduced for the same effective outcome in terms of tanning, does that
imply anything that the current schedule is harmful, that they are overexposing
people, and there could be ramifications down the road for that? I don't know if you can answer that now, but
wanted to bring that up.
MS.
MILLER: Well, I would just say that
that is really part of the driving force why we are doing this study. In 1986, we published guidance for exposure
schedules and we kind of came up with the formula as to how a manufacturer
could develop an exposure schedule that would be printed on the bed.
Since
then, the research that we have done, and also research that other people have
done, have led us to believe that the doses that are currently recommended are
too high and that they could be reduced, so that is partly why we are doing the
research.
You
might say that they are currently excessive, but the other problem is that in
addition to the recommendations currently being excessive, people will
sometimes go to salons more frequently and get more of a dose than is even recommended. That is another issue we have to I think
educate the public about.
They
don't need to get as much exposure as they might think they do, and I think
part of the problem is a lot of the people who go to tanning salons want to see
quick and immediate results, and you just can't force the skin to produce
melanin immediately, it takes some time to develop, and hopefully, if we can
educate people to take it slow, that they can get the same result with less
dose.
DR.
ROTHENBERG: I have just two clarifications
I would like. If you go back two slides
previously, to the one just before Proposed Amendment 5A, the previous slide to
that, you talk about the smaller image size.
What is the definition of image size?
MS.
MILLER: Well, these high-pressure
lamps, they are called "high-intensity" lamps. They have an arc which is about this
large. So, the image that they form on
the retina is much smaller than you would get, say, from a fluorescent
lamp. Because of that you have, in a
similar intensity being focused to a very small spot on the retina, and visible
light can cause either subtle retinal damage or even retinal burns.
DR.
ROTHENBERG: And the second question is,
do you have an idea, typically, how often do these bulbs get changed, is it
once a year, twice?
MS.
MILLER: You mean fluorescent lamps or
high-pressure lamps?
DR.
ROTHENBERG: Well, let's say for either
type.
MS.
MILLER: I really don't know about the
high-pressure lamps, and it probably would be best for someone in the audience
to answer this, but I would say less than once a year. How long?
AUDIENCE: It depends how many people.
MS.
MILLER: Yes, it really depend on the
throughput.
DR.
ROTHENBERG: The question is, is it
something that happens so often that it makes a difference, whether it happens
every month, once a year, once every five years type of thing.
AUDIENCE: Most people recommend changing it when they
degrade it to 70 percent of the original output.
MS.
MILLER: How often would that be in a
busy salon?
AUDIENCE: Once a year.
MS.
MILLER: Once a year in a busy salon,
she says.
DR.
LAMBETH: Perhaps a simple statement
about the lifetime of the bulb would help.
AUDIENCE: Most bulbs have 1,000 hours, so if you
change them every 700 hours--
MS.
MILLER: It's a value of 700 to 1,000
hours.
DR.
ROTHENBERG: I just wanted to get a feel
for the typical frequency.
Yes,
Dr. Platner.
DR.
PLATNER: I just had two short questions
or one comment and a question. The
comment is on the label. I agree with
the previous member who commented on the "may cause." To me, that implies that it is uncertain
whether it does cause, whereas, I think we are fairly certain that it can
cause. I would suggest maybe changing
"may" to "can" just because "may" sounds like
cigarette smoke cause lung cancer.
MS.
MILLER: I am not sure. It that what the warning label on cigarettes
says? But, anyway, you would have good
company because a lot of the dermatologists also have suggested that. We will have to discuss it among ourselves,
I think, to see if we feel it is required to go that route.
DR.
PLATNER: My other question is in
reference to your standard operating procedure for irradiance measurements
where you refer to the IEC 1228 method.
As you mentioned, that is currently in the process of being modified,
and I was curious how this kind of international standard or consensus standard
is reference in a regulation because it seems to me that if you just reference
it without including it, or including the date, then, you are basically
delegating your rulemaking to what is potentially a small committee.
MS.
MILLER: Well, this is kind of new
ground for us because at least in this area, we haven't approached standards
that way before, by adopting other international standards, but we certainly
would include the date, so that it would be clear which version we were talking
about.
As
far as the enforceability, like I said, this is a new area, so some of those
details are still being worked out.
Lillian mentioned this morning with the laser standard, that we have run
into some copyright issues when we tried to just put the language of the IEC
standard in our standard. So, we are
going to try to make it as understandable and as clear as possible.
So,
it is still a little bit up in the air which way is best to go.
DR.
ROTHENBERG: Dave Lambeth.
DR.
LAMBETH: I had a couple of others that
came up. In your Proposed Amendment No.
4, the wording is the spectral transmission shall not exceed. When I first read this, I was a little
concerned. I understood later from your
other slide, but you really mean the integrated spectral transmittance, which
is what you do on the next page, explain for us.
MS.
MILLER: No, actually, the way it is
written in the IEC standard is not the integrated transmittance, but the
spectral transmittance itself shall not go over 5 percent at any wavelength,
and as it is mentioned here, it needs to be measured at less than or equal to 5
nanometer intervals.
DR.
LAMBETH: Well, under your Proposed No.
4, spectral transmittance shall not exceed a value of 0.001 over the wavelength
region. I don't think in that, there is
anyplace in there that specifies the bandwidth of that measurement.
MS.
MILLER: That's the current
standard. We would also probably be
modifying just to make sure that all the measurements have to be done at 5
nanometer intervals or less for the UV and the visible.
DR.
LAMBETH: My other question was why does
one of these stops at 400 nanometers and the other one begins at 380, so that
there is this overlap?
MS.
MILLER: Well, that is really just
because, you know, there is a standard function that describes the response of
the eye and some individuals can see down to 380, not very many, but it is just
in order to use what is already out there in other standards, and that use
another eye protection, you know, safety standards, but we want to make sure
that the UV region is adequately covered, and that pretty much stops at 400.
But
I don't think it affects safety or anything to have the small overlap.
DR.
ROTHENBERG: Kim Kantner.
MS.
KANTNER: My question relates back to
the labeling and some follow-ups on the word of use of "may." It was mentioned here to consult your
physician. I was wondering if you can
elaborate a bit on what types of conditions or situations would a user consult
a physician on. Are we looking at
duration, limitation, avoidance?
MS.
MILLER: What we really intended was
since it follows the phrase about medicines, we really meant for that to be if
you are on medications, you should consult your physician before using a
product like this, because certain medicines make you more sensitive to UV.
MS.
KANTNER: So, to add to that, then,
instructions to the users would only say generally, if these cosmetics or
medications, which then they would have to be referring back to a physician to
help make those judgments on their safety, on whether or not to use?
MS.
MILLER: Are you saying are we going to
change the wording?
MS.
KANTNER: Just if there was more
explanation needed on the labeling since it is consulting your physician, I
think you had mentioned that there might be some room for elaborating a bit.
MS.
MILLER: I mean we want to keep it
short, so we have the balance of trying to keep it short and provide enough
information. We could, I suppose say
something like if you are taking medications, consult your physician because
medications and certain cosmetics may increase sensitivity, just to make it
more clear as to what we are referring to.
DR.
ROTHENBERG: Dr. Lipoti.
DR.
LIPOTI: I have one more. All of these regulations are regulations
that would not affect any equipment that is currently in use, it would only be
for equipment that is manufactured after the four years when it goes final.
MS.
MILLER: Right, and four years is a
ballpark number.
DR.
LIPOTI: Right, but I think it is an
accurate number given FDA's past history of getting these things through, so I
will go with the four years. I guess I
am wondering in that case why you need to put tags on the eyewear that doesn't provide
adequate protection for the sunlamps, for the high-pressure sunlamps.
It
seems to me that you should be able to simply not allow that eyewear to be
used. I mean if the manufacturer has
four years in which to change their product, so that it can provide adequate
protection, why are you being so careful about putting a tag on this? As you put it, it is only a small portion of
the market.
MS.
MILLER: Right, but on the other hand,
should we restrict the manufacturer of products that don't create a hazardous
situation for the majority of the products on the market. The fluorescent lamps are the major portion
of the products that are out there.
They don't pose a retinal hazard.
So,
in order to not stymie development of eyewear that is not a problem with the
vast majority of products out there, we thought it made more sense just to
allow that they can be produced for those types of beds, but in the cases where
there is a potential hazard with the high-pressure lamps, that this tag would
pretty much take care of that problem.
We
thought about having two different standards for eyewear to be used with
fluorescent lamps versus eyewear to be used with high-pressure lamps, but that
seemed to us more cumbersome in a way and since it is a small percentage of the
market, it might be simpler just to have this type of tag system.
DR.
LIPOTI: But would the tags stay with
the eyewear, or are the tags going to be taken off the first person who uses
it?
MS.
MILLER: But they are only supposed to
be used by one person. It is not
something that is given out to--
DR.
LIPOTI: It's disposable.
MS.
MILLER: Yes, most--I would say all the
cases are disposable. Supposedly, when
the salon owner gives it to them, it would have the tag on it at that time, and
if they want to tear it off after that, there is not much we can do about it,
but at least they would see it initially, and hopefully, the salon owner would
be educated enough not to give somebody this kind of eyewear when they are
going in a high-pressure bed.
DR.
ROTHENBERG: John.
DR.
CARDARELLI: Just a quick follow-up from
a previous comment regarding the statement consult your physician. Most physicians may or may not be expertise
in the area of skin and skin disorders.
Hopefully, if they are not, they would consult with a dermatologist to
answer any concerns.
I
would then offer this, that consideration be given to the addition to consult
your physician or a dermatologist, or consult a dermatologist, go to who the
experts are on these issues.
MS.
MILLER: Yes, I guess that is probably a
pretty good idea. The only concern I
would have is that most people don't have a dermatologist and that they would
be more likely to go to their primary care physician, who could then refer
them, I suppose.
DR.
CARDARELLI: I would agree, but having
the word "or a dermatologist" would also give them some intelligence,
educate them that there is a specialist in skin disorders.
MS.
MILLER: I think that is a good idea.
DR.
ROTHENBERG: Dr. Caswell.
DR.
CASWELL: A follow-up, Sharon, a comment
I guess on the label. There are really
three different types of skin cancers - squamous cell carcinoma, basal cell
carcinoma, and melanoma, and as Dr. Cyr pointed out, the relationship between
squamous cell carcinoma and ultraviolet radiation is very clear, a direct
relationship.
Basal
cell carcinoma, certainly there is a relationship there. We don't really know what that relationship
is, but it is clear that there is a relationship.
Melanoma,
as you pointed out, is a little more problematic and contentious certainly in
the scientific literature.
So, I think the clarity of saying "may
cause skin cancer" is clear, it's precise, and the user understands what
that is, and you retain scientific credibility with that.
MS.
MILLER: I agree with that, because if
you just say causes cancer, people may think that without a doubt they will get
melanoma or basal cell cancer, and as you said, the relationship there is not
crystal-clear.
CDR
LOSCOCCO: One more follow-up about the
replacement of the lamps. The one
gentleman indicated that a salon would replace a lamp if it was down to 70
percent. Is there an actual test that is done that verifies that? Is it hours of the lamp use? I am really concerned more about the in-home
user that takes a lamp out that is now down to 30 percent and puts a lamp in
that is plus 10 percent, how would they know that, is it calculated, do they
know the hours?
MS.
MILLER: No, there is really no way they
can know. Some salon owners may have
ways of measuring the output of a bed, a homeowner would not although there are
some new meters on the market that are not extremely expensive that could be
used, but I seriously doubt a homeowner would go to the trouble of purchasing
one.
There
is more of a risk to the homeowner who would put in a new bulb, and even in
salons, we know that when bulbs are replaced, people are more likely to get
burned because it is different than maybe what they had been used to.
But
we haven't seen too many reports of severe burns, so we hope that it is not a
huge issue, and we don't have any really good alternative methods since there
is not an easy way to measure the output.
CDR
LOSCOCCO: So, is there anything in the
literature that comes with the bed that says replace lamp after so many hours?
MS.
MILLER: I don't think so, no.
CDR
LOSCOCCO: And you think that when you
go back to that plus 10 percent, you had indicated that typically, you don't
get a--
MS.
MILLER: You wouldn't see a big
difference, no.
DR.
ROTHENBERG: Dr. Benson and then Dr.
Mabuchi.
DR.
BENSON: I just have another follow-up
question about the protective eyewear phrase in the proposed revised
label. It says, "Wear protective
eyewear provided." Is this too
vague for a homeowner who might lose or break the ones provided? Since you have an eyewear standard, could
you not just change the phrase to read something like "Wear only eyewear
certified for use with sunlamps," or something to that effect, so that,
you know, replacement eyewear, they would have an idea of what to do.
MS.
MILLER: Yes, I think that is a good
idea. When the standard or the warning label was originally written, we have
just kind of made slight modifications to the original language, there really
wasn't a clear definition for eyewear.
So, if we update the standard and make the eyewear requirements part of
the standard, then, we could do something like that, just so that people don't
try to wear sunglasses.
CDR
LOSCOCCO: Right. That is what I worry about.
DR.
ROTHENBERG: Dr. Mabuchi.
DR.
MABUCHI: I tend to disagree with the
characterization of epidemiological data on skin cancer, you know, cell types,
et cetera. My take is that
epidemiological evidence is that all types of skin cancer are caused by
ionizing radiation even there is uncertainty about the types of exposure,
either intense or chronic, but it is certain that UV exposure is capable of
causing, not only basal cells, but squamous cells, all types.
MS.
MILLER: You say it is capable, which to
me means it may cause.
DR.
MABUCHI: It can, yes.
DR.
ROTHENBERG: I think at this time, we
will take a short break. Let's try to
reconvene about 10:40. I would ask that
if the following people--I know some of you are here--could the following
people who are going to participate in the open public hearing, the ones we
know about so far, John Overstreet, Jim Shepherd, Joe Levy, Joe Schuster, Rick
Mattoon, Donald Smith, and Laura Edwards, during the break, just let us know
that you are here.
I
understood that possibly the first three mentioned wouldn't all speak for the
Indoor Tanning Association. Would you
please let us know, so that we will know how many people are planning to speak
and then how much time we will be able to allocate for each person.
MR.
KACZMAREK: It also might be a good time
to load any slides you have into the computer during the break.
DR.
ROTHENBERG: We will take a 15-minute
break at this time.
[Break.]
MR.
KACZMAREK: There have been some
questions about getting copies of the handouts and the overheads or the slides. My endeavor is to get everything from the
speakers and get them posted on our web site sometime after the meeting, so
don't be concerned about not getting copies of the slides or any handouts.
If
you can't wait that long, you can get ahold of me and I will try and get you a
copy. The other thing is I would ask
whoever is speaking during the open public hearing session to please remain in
the room afterwards during the committee discussion, because there is a
possibility that one of the committee members may want to ask you a question to
follow up on what you said.
Open Public Hearing
DR.
ROTHENBERG: Let me just briefly read a
statement before our first public participant.
Both
the Food and Drug Administration and the public believe in a transparent
process for information gathering and decisionmaking. To ensure such transparency at the open public hearing session of
the Advisory Committee meeting, FDA believes that it is important to understand
the context of an individual's presentation.
For
this reason, FDA encourages you, the open public hearing speaker, at the
beginning of your written or oral statement, to advise the committee of any
financial relationships that you may have with the sponsor, its product, and if
known, it direct competitors. For
example, this financial information may include the sponsor's payment of your
travel, lodging, or other expenses in connection with your attendance at the
meeting.
Likewise,
FDA encourages you at the beginning of your statement to advise the committee
if you do not have any such financial relationships. If you choose not to address this issue of financial
relationships at the beginning of your statement, it will not preclude you from
speaking.
Thank
you.
Our
first speaker will be Joe Levy from the Indoor Tanning Association.
MR.
LEVY: Good morning, Mr. Kaczmarek, Dr.
Rothenberg, and committee members. My
name is Joseph Levy. I represent the
Indoor Tanning Association.
ITA
is the world's largest association of indoor tanning facility owners and
suppliers, representing nearly 100 percent of all lamp and equipment
manufacturers in the United States and abroad and, through our relationship
with the International Smart Tan Network, the owners and operators of
approximately 6,000 tanning facilities in the United States.
Thank
you for this opportunity to speak this morning. In the spirit of constructive cooperation with FDA's Center for
Devices and Radiological Health, I want to focus primarily on this: The real world efficacy of what is being proposed.
The
spirit of the proposals introduced here today make sense, of some of them, but
what we are concerned about is that several of these proposals would mandate
changes that may not actually positively affect public health, but which would
potentially create detrimental economic effects for the indoor tanning
industry.
We
are concerned that several of these proposals are harmonizing with voluntary
international standards simply for the sake of harmonization, but not, in fact,
for the sake of better advocacy of public health. That, of course, is our common goal, so let me go through these
proposals one by one.
First,
is the FDA warning label language. I
have put a sheet in front of you that shows the proposal as we saw it last
year, as you saw this morning, the sentence "Consult your physician"
has been added to the medications and cosmetics portion of that, and that is
not reflected on what I reported to you as FDA's warning label.
We
have suggested a year ago three revisions to that label. The first revision you see in bold and the
first bullet under the warning, "The injury to unprotected
eyes." Simply, we feel that this
change accomplishes the goal, which is to get the user to understand they need
to wear the eyewear. Simply leaving it
as "Injury to the eyes and skin" does not connotate that message that
you need to wear the eyewear.
The
second change, we believe that the term "Avoid overexposure" should
be on this label because that is our common goal, we want to teach people to
tan, but not to burn.
The
third change that we suggested, and I think was also suggested by a committee
member, "Wear federally compliant eye protection intended for use with
this device" - an important distinction from simply the consumer having
the belief potentially that they could wear sunglasses or any other type of eye
protection.
The
term "Consult your physician" was added in relation to medicines and
cosmetics that may increase your sensitivity to ultraviolet radiation. I would make the suggestion that that be
"Consult your physician or pharmacist."
I
think it is pretty well documented in the photobiology community right now that
the list of photosensitizing agents is losing its meaning because there are so
many medications on the list that are simply added for liability purposes. The people who seem to have the best grasp
of this are pharmacists.
The
second point I would like to go over, inclusion of the warning label that we
just discussed in catalogs. We have an
important concern here. FDA proposes a
warning label in all catalogs, specification sheets, and descriptive brochures.
ITA
agrees that the end consumer needs to be properly educated on the use of
tanning equipment. In professional
tanning facilities, we believe the consumer already had proper access to this
information on several levels.
Consumers
who purchase home units should be provided material prior to purchase educating
them on the use of the equipment. We do
not believe this education needs to be in the form of a warning label similar to
cigarette warning labels, which was discussed when this concept was first
introduced in 2000. That would send the
wrong public health message. It would
overclassify the risk in relation to lung cancer, which kills 160,000 Americans
annually, and the American Cancer Society believes is related to 1 in 3 cancer
deaths, to ultraviolet light, which the risks of overexposure are nowhere near
that, so it should not be overpromoted, and I don't think that sends the right
public health message.
We
would like to know exactly what materials--and this is important--that FDA
would like published, and specifically, in what publications they should
appear. This needs to be distinguished
with some level of certainty before a proposal is written, and we did not get
that level of certainty this morning.
Our
third concern, the protective eyewear - visible transmission requirements. Some important clarification and
quantification is needed on this amendment.
Our current FDA regulations for eyewear only limit the transmission of
light up to 400 nm. Although IEC
suggested regulations place an additional restriction from 400 to 550 nm, we
are not familiar--this is important--we are not familiar with any data showing
that tanning lamps emit dangerous levels of light in this range. We ask data supporting the need for this
change be made available.
Creating
eyewear that is compliant to this new proposed standard will considerably
reduce the vision of the user. It may
be more difficult to see and operate the controls in the unit. That also needs to be evaluated.
This
proposal could add significant additional costs to the manufacturing process by
requiring retooling and other changes without clear indication that it will
improve public health.
Our
goal is to avoid regulations that are unnecessary and, at the same time
burdensome, so the trade-offs in this change should be evaluated and
substantiated before going forward.
Fourth
point regarding the definition of a manufacturer. Extreme care is required to develop this proposal. There are some very important
distinctions. The language of this
proposed amendment needs to be very clear and very specific. Salons should not be restricted in any way
from conducting basic maintenance or from changing a unit's lamps to a
certified compatible lamp.
Anyone
who modifies a unit by intentionally changing the unit's lamps to models that
are incompatible or who makes a change that significantly increases the output
of the unit should become a manufacturer and assume the manufacturing-related
liabilities including, but not limited to, re-certification and
re-identification of the product.
We
are not opposed to salon owners making basic modifications that do not affect
the spectral output of the tanning system.
Changing parts including, but not limited to, such items as shocks,
ballasts, starters, sockets, cooling fans, pistons, or acrylics--and these need
to be very specifically outlined in this proposal or it is going to create many
problems I assure you--that do not significantly increase the output of a unit,
do not pose a threat to compliance.
Our
next concern, major concern, with proposals to replace the FDA erythema action
spectrum with the CIE erythema action spectrum, and change the MED to maximum
timer interval from 4 MEDs at 156 joules per meter squared, to 3 MEDs.
On
both of these proposals, we would like to ask
you to ask the FDA exactly what we are trying to accomplish.
Is
the expected gain worth the considerable effort and expense required to
implement such changes?
ITS
is not confident that all of the real-world ramifications of these changes are
being considered at this point.
Has
the FDA considered the many costs to industry, such as changes in
specifications, new labeling, changes to supporting documentation, brochures,
the potential impact on state regulations,
and perhaps most important, confusion and reeducation for consumers and
salon owners in the retail sector.
Lamp
manufacturers have decades of accumulated data using the FDA erythema action
spectrum. This data could become
useless if the standard is changed.
We
would therefore suggest to hold a stakeholder meeting with FDA to be conducted
to reveal these issues prior to developing any written proposal.
Our
next concern regards the IEC proposed X/Y lamp coding system. Again, we do not believe the FDA has
demonstrated a clear need for this change.
Our
constituents believe that use of the non-melanoma skin cancer weighting
function in this standard has the potential of causing major economic problems
in the future, and we believe the
utility of enacting this change needs to be more clearly examined and taken
into account.
This
is important. Health Canada, the
Canadian equivalent to FDA, has not proposed this change in its current rule
review, according to the Joint Canadian Tanning Association. This would create two different standards in
the North American market.
Now,
we talked about the goal of harmonization being to facilitate international
trade. This would create a very
confusing atmosphere because a lot of equipment from the United States goes
into Canada, and this would create two standards.
The
system introduces the non-melanoma skin cancer action spectrum into the lamp
rating systems.
DR.
ROTHENBERG: One minute.
MR.
LEVY: Okay. This spectrum is most certain to change in the future as more
studies develop additional information about UV and non-melanoma skin cancer. This is going to change. Therefore, this change could result in a
situation where the current standard is changed for no apparent reason and will
have to be changed again in the future if that standard changes.
We
are strongly opposed to pursuing international harmonization simply for the
sake of harmonization. ITA in January
of this year hosted the first-ever World Summit of Indoor Tanning Trade
Associations in New York. We had 33
delegates from 12 countries joined us in discussing the state of world tanning
regulations.
It
is important to note that based on conversations in the past year with our
European counterparts, IEC standards, which are voluntary, are not even
followed in Europe. In addition, where
IEC standards are required, regulations based on these standards have had
severe negative impacts on the industry.
The
standards were developed without organized comprehensive input from the indoor
tanning industry. That is why so many
of them don't make perfect sense in the real world environment.
I
will let you read the rest of my comments for the sake of time.
Thank
you.
DR.
ROTHENBERG: Okay. Thank you.
I
think we will go to the other presenters and then see what questions the
committee may have overall, if you could just stay here for the remainder, we
would appreciate it.
Our
next speaker is Joe Schuster. MR. SCHUSTER: Good morning, ladies and gentlemen, the TEPRSSC Committee. I am Joe Schuster with Light Sources and
also representing the Suntanning Association for Education.
Comments
that I wanted to share today basically will be for your information,
background, additional support when you are considering the various proposals
that have been made today.
I
represent the Suntanning Association for Education in addition to Light
Sources, and I think it is important for you members to know that there are
educational bodies that are out there that are teaching accredited indoor
tanning operator training throughout this country, the Suntanning Association
for Education, as well as two other groups, National Tanning Training Institute
and Smart Tan, make up the core of education in this country.
I
think the comment was made earlier about education. That is where I would like to see some direction. There are certain states that have mandatory
educational requirements in this country, not all, but some - North Carolina,
South Carolina, Florida, Oregon.
These
are good things where the indoor tanning operator is required to go pass an
accredited operator training program. I
would like to see more of that. I know
it is not an FDA recommendation, but you need to consider it when you are looking
at these different proposals.
Let's
talk a second for the state of technology in this industry. The indoor tanning lamp, it has developed
over the past few years. Research that
has been presented to the FDA has primarily relied upon solar simulators and
FS40 sunlamps that emit pure UVB.
For
the first time, we are seeing lamps that are used by Sharon Miller, Howard Cyr,
that are good. They are indoor tanning
lamps being used to look for study purposes, but the industry grows and
chances, currently maybe as much a 25 to 30 percent are using much more
effective lamps now for producing a sun tan, lamps that are also known as very
high output reflector lamps.
You
heard the comment about reflector and degree of reflectivity. These are good things, but it changes what
goes on now. So, now the time frame
that is needed, we talked about 20 minutes, you are hearing 20 minutes a lot.
Maybe it is now as short as 8 minutes, 9 minutes. So the lamps are becoming much more effective.
Here
is what happens. We talked about
maintenance. The lamps don't last as
long, we heard 1,000 hour comments.
These lamps are run typically through much higher wattage systems. The lamps don't last as long. The end result is the output goes down as
the maintenance curve drops, the output goes down. The end result to the tanner is a less or a lower dosage than
what was originally given when the lamps were new.
How
often do salon owners change lamps? You
asked that question. Good
question. I would love to say they
change them as per manufacturer's recommendations. Unfortunately, in this economic environment, people stretch them
out, they don't change them as often as they should, but what is the result to
the tanner? Lower dosage. It doesn't mean an increased dosage, a lower
dosage.
The
tanner lies in a tanning bed on an acrylic shield. These acrylics deteriorate over time, so that they become less
effective at transmitting UV as the bed goes through its properties, so once
again, what happens? A lower dosage,
not an increased dosage.
It
is almost like with a car, you want to make sure the car is tuned properly, you
change the oil, and so forth, it becomes a very well running engine. How often does everybody take their car to
get a complete tune-up? Not as often,
and certainly the economy may affect how often people do that.
So,
keep this in mind, salon owners are stretching this time frame out
further. I would like to say that
everybody doesn't, they do it properly, they don't. So, it's a lower dosage that is going on, much less effective due
to those two particular points.
Let's
talk for a minute about the X/Y lamp compatibility suggestion. I certainly understand the direction to
harmonize with IEC standards. I think
Joe brought up some of the concerns about trying to harmonize, sometimes it
doesn't.
The
X/Y issue had dictated I think lamps according to wattage. Understand that that ballast system that is
driving the wattage has a direct reflect on what type of output it gives. Not all 100-watt lamps, 120-watt lamps,
180-watt laps are driven by the same type of corresponding ballast.
If
a ballast that is meant for a 120-watt lamp, if it's only 100 watts, it doesn't
deliver the true output of what you might think it would be, so you have to
consider what is the operating system that is being used in.
The
point is, too, for lamp compatibility, to make it easier--make it easier for
people to change their lamps when it becomes the time, my gosh, all the
different lamps, consider how many thousands of tanning beds that are out
there, and they are not only in major metropolitan areas, they are out in the
suburbs, out in the country, I mean it would be an unbelievable task to try and
get people to understand we have two systems now, one for the current way we
are looking at it, and one for all the thousands of beds that are out there.
You
talk about the homeowner. How often
does the homeowner--that was a concern--how often do they rotate the
lamps. Those lamps that are being used
are typically 800 to 1,000 hour lamps.
On a 20-minute session, that's 3,000 hours. A homeowner is not going to go ahead and change lamps that
often. It may be for the life of the
bed that they have, it is going to stay in that particular system.
The
last comment I want to share with you is on the warning label, and we addressed
it. I certainly understand your
concerns. I look towards making things,
I think you have to consider making things not so much of an absolute because
what would constitute obtaining skin cancer, if you say it may cause skin
cancer, certainly, there are a lot of different variables - your heredity, we
talked about melanoma skin cancer, heredity plays a large role, but when you
look at it, "it will cause," what type of exposure will cause it,
when I lie in that bed once, I will get it, that is an absolute.
I
think we have to be a little bit more flexible on that and consider it might,
it may, it is possible, but by saying it will without defining what exposure
will give it to you, I think it is hard to fit.
In
any case, I thank you for your time and I hope you take these comments into
consideration.
Thank
you.
DR.
ROTHENBERG: Thank you very much.
Our
next speaker is Rick Mattoon. Again,
please identify your connection, if any.
MR.
MATTOON: Thank you. My name is Rick Mattoon. I am actually
representing two organizations here today. First of all, I am here as Director
of the National Training Institute, which is a national training program for
various industries. Our primary
training program institutes a specific course for the operation of an indoor
tanning facility.
Secondly,
I am also here as Executive Editor of Looking Fit Magazine, which is an indoor
tanning trade publication which circulates to 22,000 tanning facilities across
the country every month.
To
kind of consolidate the time here and move along quickly, I have prepared a
statement there that I passed out during the last break, and I am just going to
read from it briefly and then be available for any questions or comments
afterwards.
I
am submitting the statement to the Committee in response to two of the
recommendations by the Food and Drug Administration regarding proposed
amendments to the U.S. performance standards for sunlamp products. Due to the time constraints of the
Committee, I will not speak on all proposed changes, however, I would like to
make several comments related to two of the proposals.
The
first proposal is Warning Label Inclusion on all Promotional Material. Although I agree on the importance of
consumer-based warning labels on any product that has the potential to cause
harm if used improperly, I would remind the Committee to consider the principal
intended target of a warning label on a tanning device. This label is primarily intended for the
consumer using the device for tanning purposes.
The
primary function of any warning label is to protect those who are least able to
protect themselves, in this case, the tanning consumer. People most likely to misuse a product are
not typically those who are about to invest $2,500 for a single tanning unit to
$250,000 for an entire tanning facility.
These
individuals have typically researched the market, compared products, tested
equipment in a salon setting, and have most likely participated in one of three
nationally recognized indoor tanning certification programs that routinely
cover the adverse effects caused by the misuse of a tanning device.
To
require a legible reproduction of the warning statement required by 21 CFR
1040.20 to all catalogs, specification sheets and descriptive brochures, and
any other purchasing information pertaining to each sunlamp product and
ultraviolet lamp is simply overkill.
Let's
keep the warning label on the equipment so the intended user can have access to
this information and, at most, include a reproduction of the label in the
operator's manual where it makes sense.
Let's
ask this question. What is a label
supposed to achieve? It is supposed to
create awareness and give education.
Research has shown that warning labels are most effective when it offers
new information that is believable and that is targeted to the intended
audience at an appropriate time.
As
executive editor of LOOKING FIT magazine, the indoor tanning trade publication,
I can attest to the fact that warning labels within promotional advertising in
publications like ours or within informational brochures is not only
ineffective, it can also be financially restrictive to some companies.
Secondly,
I would like to just quickly comment on the redefining of a manufacturer. The proposal that "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 function(s)" be deemed
a manufacturer could and would be detrimental to the daily activities of more
than 60,000 legitimate businesses across the U.S. that offer commercial tanning
devices.
The
FDA's revision for the definition of a manufacturer should be considered very
carefully. Currently, most salon owners
maintain and repair equipment themselves.
Occasionally, maintenance or repairs go from routine to complex. The definition of a manufacturer must be
detailed in great detail.
Even
in aircraft maintenance, there are two definitions of "modification"
during routine or major repairs. I have
defined those in the handout as minor and major modifications which I think we
can learn from.
Prior
to redefining a manufacturer, we must clearly define repairs or modifications that
do not "significantly" affect the structural integrity or intended
output of a tanning device. This can be
accomplished by working closely with manufacturers and, most importantly, salon
owners who routinely service and repair their equipment. For a salon owner to unwittingly cross the
line on manufacturer status would be a financial disaster from which most could
not recover.
In
conclusion, considering the common goals among agencies and industry, it is my
wish that both groups work more jointly in developing and defining objectives
that have the needs of the tanning consumer utmost in mind.
I
appreciate this opportunity today to submit this statement to the
Committee. I hope that this statement
and my future submissions and interactions will assist the Committee in their
work on these important topics.
Thank
you.
DR.
ROTHENBERG: Thank you very much.
Our
next speaker is Donald Smith.
MR.
SMITH: Good morning. My name is Donald L. Smith, UVR Research
Institute in Tucson, Arizona. Both my
trip here and the research that you will see here presented were funded by my
wife and myself personally.
Let's
take a look, if we could, at some information from the Freedom of Information
Act that I filed a few years ago. FDA
sent me a wide variety of information and over a 15-year period, which is the
time during which the existing action spectrum has been in force, we had 84
complaints, which means about one complaint for every 100 million tanning
sessions. That is an enviable FDA
complaint history by any standard.
Now,
part of the credit goes to the educational programs, the professionalism of the
salon owners and the manufacturers, but much of the credit for this enviable
complaint history has to go to FDA's Dr. David Lytle and his colleagues for
having the courage and the foresight to develop a more protective erythemal
action spectrum, the FDA EAS, rather than adopt the less protective CIE action
spectrum in 1985.
For
your information, Dr. Lytle wrote a very reasoned letter to CIE explaining why
that was rejected way back then.
Today,
FDA is recommending adopting the same less protective action spectrum that was
rejected by Dr. Lytle and his associates in 1985, a recommendation that will
increase the erythemal risk of the American public who of their own free will
choose to tan.
On
the other hand, I recommend staying with the more protective FDA action
spectrum because it decreases the erythemal risk of the American public who
choose to tan.
In
addition, FDA wants to adopt the totally unproven and very difficult, if not
impossible, to understand X/Y ratio system for labeling sunlamps. I recommend improving the existing system
and adopting an easy-to-understand Bin system.
Paradoxically
and counterintuitively, FDA is recommending the less protective CIE, while I am
recommending the most protective erythemal action spectrum in the world - FDA's
own.
FDA
is recommending an unproven and difficult-to-understand system, while I
recommend an intuitive and easy-to-understand system. At stake in this dispute between politics of global harmonization
and science is the safety of the American public who choose of their own free
will to tan in the professional indoor tanning salon.
Let's
talk about the doctrine and what is sauce for the good is sauce for the
gander. Companies that fall under FDA's
jurisdiction have to provide proof of efficacy before they can market their
products. Therefore, it seems to me
that FDA should be held to the same or higher standards of proof before they
can make changes.
TEPRSSC,
like the NASA Safety Committee, have the responsibility to make sure that they
provide adequate proof.
FDA
not only provided inadequate proof, they provided no proof to support the
changes from the more protective to the less protective. FDA has not conducted adequate studies, in
fact, no studies that I am aware of, to show supporting adopting the
non-melanoma skin cancer action spectrum.
For
your information, the NMSC was originally incarnated for ozone depletion
studies, it is only now being used here.
They haven't considered the needless confusion that will ensue, nor did
they pay any attention to the absolutely overwhelming negative response that
this X/Y system received in February of 2002.
Instead, we are making these draconian changes for the politics of
global harmonization.
Well,
let's take a look at why the FDA is more protective. We have a broader 1.0 weighting factor used by FDA. CIE goes 280 to 298, FDA, 280 to 302
nanometers, and so the CIE is therefore 28 percent less protective.
Here
is looking at it from 250 to 400. Let's
take a look at it here from 280 to 320.
It's this delta that was the genius, this is a fudge factor that Dr.
Lytle and these people put in because the photon distribution here, it is
weighted more heavily, so that's the first factor.
The
second one was by choosing a lower threshold,
156 versus 200. It also applied
another fudge factor. So, the
theoretical difference therefore between the two action spectrum is 1 FDA to
1.5 CIE.
Well,
the theory is good, but what happens in actual practice? Here are some studies I did with lamps. The
theoretical is 1.5. If you take a GE
black light PUVA lamp, you see that it is 1.51. You can buy a black light lamp in any Home Depot, and it will
come out about 1.52 to 1.53 and the relationship.
But
as the UVB increases, there is a 1 percent high-intensity discharge
high-pressure lamp. Here is a typical
20-minute, 3.5, and here is a 10-minute high UVB, so the ratio between the two
action spectrum changes by the distribution of the photons in the UVB and the
UVA two ranges.
So,
FDA responded to this by changing the maximum allowable dose from 800 to 600
joules per meter. Well, that helped
some, but there is still this discrepancy.
Now, what does this mean?
If
time doesn't permit, this chart sums everything up, and I ask you all to pay
attention. Here is the theoretical, and
so switching from the FDA to the CIE would mean a change that this bed that is
going 20 now, would be allowed to go to 24, and it proves out in the theoretical.
So,
the 1 percent range, we would be saying it's 20 today, 27 now; the typical bed
20 today, 30 minutes before, and here is this high UVB where you have a high
burning power 10 today, 17 under this.
Now,
in February 2002, ladies and gentlemen, a regulator from Europe said, made the
statement at that meeting that 9 percent of the people in Europe that attended
a tanning salon would sunburn. We
pooh-poohed, thought it was heat flush or lotions or whatever, but after I
plotted these out, if they are letting them go 17 or 20 minutes in a bed we
have 10, then, maybe they are sunburning them, but we don't have this.
Once
again, this chart clearly shows the wisdom of Dr. Lytle and his colleagues for
us adopting it, it's fudge factors, but they have been very protective and they
have stood the test of time. So, this
chart shows it, and FDA has not run any studies to compare these things, so
therefore they haven't seen these things.
Here,
we see these things. Now, Ms. Miller
presented some things, so now we have this 47 to 52, but these are ivory tower,
folks. When you look at total
irradiances that are possible, it is like putting one foot in hot water and
another in a block of ice. On the
average, it is going to come out okay, but total irradiance will never show you
the photon distribution within the different wavelengths.
Now,
they are asking a totally unproven system with the X/Y ratio. To the best of my knowledge, this is not in
place anywhere in the world. Still,
testing a single lamp in a test stand does not tell you how to calculate
exposure schedules. For that, you have
to have a standard protocol for measuring the array of sunlamps, i.e., the
sunbed.
So,
we are going to have a mass amount of confusion that is going to simply
adversely affect the tanning public. We
have got to look at what this ideal system should be.
First
of all, it has to be easy to understand by all segments, and believe me,
clients ask questions about these. It
has to be logical, intuitive, has to be easy and inexpensive, and it has to
resolve these two issues of sunlamp compatibility and exposure schedules.
We
talk in language of the beds. We have
got 30-minute beds, 20-minute beds, 15, and so on. I proposed at this meeting a bin system, taking bins and the
beds, so if we have 30-minute beds and 30-minute bins, and let's look at what
it would mean on a 20-minute bed.
Simply
said, if you have a 20-minute bed, you could use a lamp that has a TE time of
from 17 to 30. Now, the existing system
is plus or minus 10, why did I go down to 15?
That is simply because if you take the manufacturing error and the
testing area, we will never work within plus or minus 10 percent. Our allowances, we are going to be lucky to
work with 15.
So,
this is something I have explained it to hundreds of tanning salon owners, and
they understand this immediately.
So,
here is the proposed system that FDA has, which is ivory tower, and what I
propose is common sense and easy to understand.
Now,
this action spectrum is for squamous cell carcinoma in albino mice that were
irradiated with a lot of different lamps, but the predominant one were FS-40s
with UVC at high levels. It is not an
action spectrum for doing our lamps, it was never intended that, as I said, it
was intended for the ozone depletion.
Here
is what it looks like, from 250 out to 400, but let's look at it here. Ms. Miller showed you a log plot, but that
is what it looks like.
Now,
ladies and gentlemen, I have 6,000 articles in my Notes File, I went through
them all, and everything that has been published in the literature for the last
30 years says these are the wavelengths associated with the induction of
squamous cell carcinoma. So, why would
you use an action spectrum that devalues those very wavelengths? The answer is you wouldn't.
So,
here is the more protective FDA, here is the less protective CIE, here is this
non-melanoma skin cancer action spectrum they are asking you to bless, and this
is the melanogenesis action spectrum according to Parish where we calculate the
TM value.
So,
what they are saying is they want to use one that is even weaker and have less
power than the one we use for TM. So,
this one won't fly.
Here
is the FS-40, here are some other lamps, Xenon filtered, Xenon unfiltered, the
FS-340, it was called the Q-Sun, and here, you can see the comparison when you
look at the A and B here versus over here.
These lamps are not reflective.
It
might be helpful for you to see how here is sunlight, the Xenon low pressure or
high pressure/low pressure, and here is the filtered and the unfiltered lamps.
So, if you look at it just for the A and the B classifications, you can see
that the lamps used for these studies were not good.
The
key thing here is consequently, in studies designed to understand skin biology
after solar exposure, the use of these sunlamps may lead in misleading or even
incorrect conclusions.
So,
it is not an appropriate thing, and it is going to damage the industry, as has
been mentioned, it's political, not scientific, it is simply to get the word
"cancer" incorporated.
Ms.
Miller didn't tell you, but me say I clarified it with her before the meeting,
the Y/X's will be the power of that sunlamp to cause skin cancer, that's what
it is. So, you need to think through
what this is going to do to get liability insurance for vendors and salon
owners.
Well,
that is what they proposed on the warning label. Here is what I proposed in the letter. It is overexposure of ultraviolet irradiation that may cause
this, not exposure. Furthermore, I suggested
saying individuals taking a medication or using a cosmetic product that may
increase their sensitivity to ultraviolet radiation should check with their
physician or pharmacist before tanning. That is on our standard informed
consent form.
Individual
with systemic lupus erythematosus, rosacea, or who have received medical
treatment for a diagnosis of skin cancer should check with their physician
before tanning. If they want to put
physician/dermatologist in there, I have no problem.
You
know, we worry about all these little things, but people who have lupus, who
read on the web sites that UV irradiation is beneficial, they are talking about
UVA-1, and they go in a bad blood spectrum, and it's damaging.
DR.
ROTHENBERG: Please finish up.
MR.
SMITH: The definition of manufacturer,
the same thing I said to you folks last year, if you don't have a standard
protocol for measuring performance, which is at the heart of this, then, you
can't have a regulation that depends on it.
So,
first, we need to get a standard protocol before this.
Let's
talk about these lamps, and I want to go right to this. Here is a lamp that I ran, the standard low
pressure. It isn't just high pressure
things, the problem actually is more acute in the low pressure lamps with the
eyewear, because here is the spectrum and here is the spectrum that you see
here after I put the eyewear. This is
the least protective eyewear.
You
can see it gets rid of the mercury peak at 405, but it doesn't get rid of it
all out here at 436 and at 550. So,
now, if you look at this and plot it out, you can see that for the most part,
and the average is 2.7 percent, and integrating it, and, Doctor, the question
you asked before, you do have to integrate it by 5 nanometer increments, but we
violate it here.
So,
what we need to do is to ask people like Dr. David Sliney [ph] of the Army, is
this--because it's very low levels--the fact that it violates this, is this
meaningful, because keep in mind when you look at this, that here is the
Hobson's Choice. If you restrict the
ability of lenses that have more transmission, that they wear in these new beds
that have a lot of controls, then, you tempt the people to remove their glasses
to see the controls where they are affected to this.
So,
what we need to do is to find out is this amount of irradiance passing through
here on these two mercury peaks, or, conversely, can the lamp manufacturers
reduce this, so it isn't there.
Okay. Approve the revised label with the
overexposures and the other. Instruct
FDA to go back. We have got a lot more
work to do before we can standardize the eyewear products, and we need to
develop standard protocols for testing sunlamps and sunbeds before we can do
any of these things.
Reject
them to change from the more protective FDA erythemal action spectrum to the
less protective CIE, adopt the unproven, politically motivated X/Y system, and
work with us to improve the existing system and make protecting the American
public, not global harmonization, their first priority.
Ladies
and gentlemen, in my opinion, what we need to do is to put America first.
Thank
you.
DR.
ROTHENBERG: Thank you.
We
have one additional speaker, Laura Edwards.
Please again identify your organization.
MS.
EDWARDS: I would like to thank the
committee for the opportunity to speak.
My name is Laura Saul Edwards. I
am the Assistant Director of Federal Affairs with the American Academy of
Dermatology Association, which represents 13,000 dermatologists nationwide.
I
do not have any financial interest supporting my appearance here. Indeed, the sole concern of the Association
is the public health concern. Based on
that, the AADA's policy with respect to indoor tanning is--I am sure you are
not surprised--we would like to see indoor tanning go away and have it
completely banned, but in the absence of a ban, we do support having this
industry highly regulated to protect the public's health to the greatest extent
possible.
It
was with that in mind that we gladly accepted the offer to meet with the FDA
officials involved with this in June at Howard Cyr's invitation. It was a very productive meeting where our
leaders on this issue learned more about how FDA approaches regulating the
industry, and they learned about our clinical and scientific concerns with the
industry.
So,
we are also very appreciative of this proposal. Priority to the Association is the warning label, Proposal No.
1. I was encouraged to hear around the
table the concern, as well, with the language of "may" versus other
suggestions for strengthening that label.
The
AADA urges the committee to support strengthening the label, to please delete
the word "may," replace it with "can" or "is known to
cause cancer."
This
is a scientific fact. This would just
strengthen I think the public health concerns that I have heard the prior
speakers mention, and if you would like to discuss this at greater length, I am
pleased to comment on that.
As
far as the other proposals included in this package, the AADA is considering
them closely. They would be happy to
provide additional comment to the committee and the CHRD, particularly Dr.
Miller, as this proposal is developed.
Our Environment and Drugs Committee is analyzing it.
At
this time, I am going to close my comments.
I will stay and be available for any questions that you might have. Again, thank you.
Committee Discussion
DR.
ROTHENBERG: Thank you very much.
Do
either Dr. Cyr or Sharon Miller have any comments that you would want to make
at this time regarding our public presentations?
MS.
MILLER: Yes. Where do I begin? There
are several things mentioned by the speakers that I feel I should comment on. Basically, I would just like to say it was
mentioned that harmonization for harmonization's sake may not be the way to go,
and it is true that FDA has a federal mandate to harmonize with existing
international standards, but also what is really driving us is to improve
safety to the public. That is our main
goal.
These
international standards have been developed by a large panel of international
experts, so we don't feel that they have been created foolishly or
prematurely. This committee, the EIC
Committee has been in existence for probably 15 years and consists of very well
known experts in the field, people from academia, people from
government-regulating bodies, so we don't think any of these recommendations
have been taken lightly.
As
far as some of the specific suggestions that were made, one person suggested
that in the warning label, we should specify that the injuries to the eye are
only in the case of unprotected eyes. I
feel that the way the label is worded, it says, "Ultraviolet radiation may
cause injury to the eye and skin," and that's a true statement.
If
you were saying sunlamp exposure may cause injury to the eye and skin, that
might be true only in the case of the unprotected eye, but I think in the
interest of keeping the label as short as possible, that it doesn't really add
anything to say that it causes injury to the unprotected eye because if we tell
people it causes injury or can cause injury to the eye, and wear the protective
eyewear, I feel that that provides adequate instruction to the user.
Also,
with regards to the warning label, someone suggested that we say not that
exposure may cause, but that overexposure may cause skin cancer and skin aging,
and so forth. We don't like the use of
the word "overexposure" in that instance because overexposure is a
very ambiguous term. An individual does not know what overexposure means to
them, and they certainly won't know until the next day whether they have been
overexposed, because the erythema will not show up until 24 hours later
approximately.
So,
we prefer just to keep it at exposure.
Several
people mentioned that some of our changes could cause detrimental financial,
could have a financial impact on the industry, and as I mentioned before, FDA
is required to do an economic impact analysis, so many of those considerations
will be addressed during that analysis session.
A
change in the action spectra may cause some problems for bookkeeping for the
industry. It is true they have been
using this action spectrum, they have experience with it, but we don't feel
that with the state of computers and the ease of use of spreadsheets, that
changing the action spectrum will prove that difficult.
As
I say, it is already used in the FDA standard and I think it's just in the long
run, will be simpler for everyone in this business to be using one action
spectrum, and not two, one for the U.S. and one for the rest of the world.
It
was also mentioned that our standard, that the proposals we are presenting here
today are not in a line with what Health Canada has in their standard. We work very closely with people from Health
Canada. They have made changes to their
standard probably in the past, I don't know, maybe six months ago.
Some
of the changes we are presenting today are more recent developments in the
international standard community, so that is why they are not in their
standard, but we know from our discussions with them, that they do plan to go
the same route that we go. They
probably will be proposing the same changes in their standard in the near
future.
Regarding
Don Smith's presentation on the changing of the action spectrum, I think his
presentation was a bit misleading because it is true the CIE action spectrum
has lower relative effectiveness values in a portion of the spectral area, what
is really important, though, I believe, is what the total dose is.
The
numbers that he is showing you were comparing an MED of 156 to an MED of 200,
but what is really important, in my mind, is that the maximum timer limit is
still approximately 600 joules, and, in fact, that is lower than what is in the
current FDA standard, which is 624 joules based on 4 MEDs.
If
we go to 3 MEDs of the new level of 200, that will only be 600, so it is
actually a lowering of the effective dose, and the effective dose is more
important than the individual weighting values are giving to each region.
As
I said, this action spectrum has been well tested on thousands of people all
over the world to show that it is at least accurate in predicting erythema for
different types of lamps.
As
far as the rating system goes, I was a little confused by some of Don's remarks
about the X/Y system being discussed in 2001 because this system was really
just introduced in June of this year, so I don't know what he is referring to
there.
But
we don't think, once people get used to it, it will be that difficult to
understand. As far as it being a
liability for people for manufacturers or salon owners to have a cancer number,
since we know that UV does cause cancer, we don't feel that having a number
that represents the non-melanoma skin cancer action-weighted output really
changes the situation.
It
doesn't make the lamps any more dangerous or more safe, it just describes them
according to this other action spectrum.
I am not a lawyer, I don't know if that gives people any more
ammunition, but we don't feel that it would cause a big detriment to the
industry.
As
Don was saying, changing the action spectrum and the dose would increase the
dose that the people receive, we would say that, no, in fact, it is going to
lower the doses. Some of the
information he presented on the label, we think it is getting too long, and if
salons want to use an informed consent, we highly recommend that, and I think
that is where that kind of information belongs.
Lastly,
I just want to make a comment about his slides he showed about eyewear. He was I think trying to say that some of the
fluorescent lamps are also a problem in the visible region, but when you are
talking about retinal hazards, the geometry is really more important than the
actual output of the lamps itself.
You
can't just look at the output of a fluorescent lamp and compare it to a high
pressure lamp and say, well, this is higher, therefore, it is more of a hazard
because the geometry is a much more important factor in that case.
That
is all I have to say.
DR.
ROTHENBERG: Does this committee have
questions for Sharon Miller or also any of our previous presenters? Yes, Jim.
DR.
PLATNER: Just a real quick one for
Sharon. This is regarding the
definition of the manufacturer. It
wasn't clear to me from what we received that that included importers.
MS.
MILLER: I think the intention is for
that to include everybody who wants to market their products in the United
States. I am glad you brought that up
because I wanted to also say something about that.
It
is true we do not want salon owners to have to generate a lot of paperwork
needlessly, and I feel that the way the language is written, it says that if
the modification affects any aspects that are specified by the standards, so if
it affects the timer, if it has any effect on the warning label or the
instructions for use, things like that, then, they would have to recertify the
product, but simple things like changing sockets and mechanical issues are not
going to be--the way the standard is written, it would not be considered
something that would rise to the level of requiring them to submit a lot of
paperwork.
DR.
ROTHENBERG: Michele.
CDR
LOSCOCCO: Just one quick one. Any confusion that might come about from
this X/Y ratio versus how it is now, that would pan out during this period of
time where you have to do a market evaluation?
MS.
MILLER: Yes. It may be difficult making the transition. The way it is done now is each manufacturer
of the lamp, like I said, will publish a list of compatible lamps to theirs, so
we are hoping that as new lamps are coming into production with the new code,
it can be somehow merged with these old lists and eventually, the lamps expire,
that problem will take care of itself.
Should
I put the six proposals up again? Are
you ready to, do you think, make any decision?
MR.
KACZMAREK: If there is no more
questions.
DR.
ROTHENBERG: Are there questions? Yes, John.
DR.
CARDARELLI: Just one brief question
regarding a comment made about putting labels in publications and catalogs, and
things of that nature. What was the
basis behind making such a recommendation?
MS.
MILLER: Our real intention was mostly
to protect the person who buys it for home use. You have probably seen catalogs that you usually get on an
airplane that sell sunbed products for home use, and it is really the home user
that we are trying to protect in that case.
As
I said, that requirement is also in the laser standard, which probably even
more so than the sunlamp area, doesn't affect individual consumers as much, but
I think, I think it was Rick Mattoon, had a good point, and that is something
we might want to change, only require it in advertising targeted at individual
consumers, and not necessarily at salon owners, because they all know that this
warning label exists. We just don't
want someone buying it and not knowing that there are risks involved.
DR.
ROTHENBERG: Anyone else from the
committee?
MR.
SMITH: A brief response.
MS.
MILLER: In rebuttal?
DR.
ROTHENBERG: Brief. The question that I would like to suggest
that you ask Ms. Miller before you get into vote, is since I presented hard
data showing that the impact of changing from the existing action spectrum that
served us well for 18 years, to the CIE action spectrum, because of the
weighting and the calculation nanometer, will be adverse. It will adversely affect the health of the
American people who choose to tan, and I showed you documentation on that from
studies.
It
seems to me that the question you should be asking of Ms. Miller, if FDA has
studies to substantiate this, studies showing the impact of the X/Y
system. That is the question, because
if you are going to insist on this, those of us that tan people for a living
know that you can't put people in for 17 or 20 minutes in a 10-minute bed. That is just plain fact of life.
So,
if you do that, then perhaps we have to talk about how do we indemnify the
industry from the adverse effects that this may have.
MS.
MILLER: Well, I still think there must
be a misunderstanding on Don's part because the goal, as I have shown, is that
the dose would actually be lower now with the new action spectrum and the new
definition of MED, therefore, a bed that was once a 17-minute bed, might turn
out to be a 16-minute bed now.
There
is no way that it can increase with using a lower effective total dose for the
timer. I think he is basing his
calculations on comparing the old MED to the new MED, which is 156 to 200, and
not looking at the 600 versus 624. We
are certainly not trying to increase the dose to the public.
As
far as asking for a study on the X/Y system, obviously, we are never going to
have an action spectrum for cancer in humans, so we can't really test this
action spectrum out on people and say yes, this is working, this is protecting
people.
But
we know that in animals, it is an accurate action spectrum for squamous cell
carcinoma, and we feel that it provides extra protection since we are using
both erythema, which is how the current system relies upon, and the
non-melanoma skin cancer action spectrum that we are actually increasing the long-term
safety of the products.
DR.
LAMBETH: Would you mind putting the two
action spectra back up?
MS.
MILLER: There, they are shown on a log
scale. The pink one is the non-melanoma skin cancer action spectrum. You can see that in the region below 300,
the erythema action spectrum is higher, but then there is another difference
around the 330 nanometers where the erythema action spectrum is higher than the
non-melanoma skin cancer action spectrum.
I
don't know if Janusz Beer wants to say anything about this. He has been a little bit more intimately
involved with the development of this action spectrum than I have.
DR.
LAMBETH: So, is the argument here that
below 300 nanometers, that because--let me just refer to it as the purple
curve--is much lower, in fact, it is a factor of 100 lower, right? That is a log scale.
MS.
MILLER: Right.
DR.
LAMBETH: That in the weighting process,
it is not being counted as much as being a problem?
MS.
MILLER: Do you want to answer that?
DR.
BEER: I can try to add a few things to
this information that you see on this graph.
The erythema actually is a spectrum below 300 as was proposed in a
straight line, because there was uncertainty in this area.
The
non-melanoma skin cancer action spectrum is based on experimental points, so it
was easier to develop this action spectrum in the low wavelength region.
Now,
the two action spectra, as you can see, are similar, and the bottom thing is
that 300 mm UV radiation does not penetrate very deeply into the skin. As a matter of fact, most of this radiation
is absorbed in the stratum corneum, so this part of the action spectrum is not
very critical for establishing the safety.
MS.
MILLER: Yes, I was going to say the
same thing, that it is really the fact that the transmission of skin is not
very high in that region. That is why
this animal data--not animal data, it is animal data that has been adjusted to
human skin--is lower in this region, and the erythema action spectrum was a
simplified version of experimental data that was developed on humans.
DR.
LAMBETH: So, there is no denying that
if the very high energy wavelengths were to get through the skin, that they
would be harmful. It is just that the
skin represents a filter to prevent that from getting in--
MS.
MILLER: I think that is true.
DR.
LAMBETH: That is your argument, right?
MS.
MILLER: We think that by using both,
that we are able to protect the public against burns and also keep similar
lamps that have similar long-term effects being repeatedly used in products, so
that we are not changing the long-term effects substantially when the lamps are
changed.
DR.
ROTHENBERG: Dr. Caswell.
DR.
CASWELL: What effect does the acrylic
have on the spectrum that the user receives in the tanning?
MS.
MILLER: Yes, it will definitely have an
effect. As far as I know, most acrylics
start transmitting around 270 nanometers, so anything below that is probably
not getting to the user. There are some
sunbeds that don't have acrylics, it is very rare, but especially in the upper
canopy, they may not have an acrylic.
In that case, you would have the concern of the lower wavelength.
As
I think Joe Schuster or someone mentioned, as the acrylic ages, the
transmittance even starts shifting further into the longer wavelength. The acrylic definitely will have an effect
on what the user receives.
MS.
KANTNER: If you could just refresh on
what area of the wavelength here that we are targeting, you said that was
between or below 300? On the spectrum I
guess of the lamps, I thought I saw a different chart. I am trying to determine on the wavelength
region here, is that 270?
MS.
MILLER: You mean the lower?
MS.
KANTNER: Yes.
MS.
MILLER: It starts at 250 and it goes
out to 400, for 10 it is actually shown, but the spectrum stops at 400.
MS.
KANTNER: So, if I may, maybe use this
laser pointer. So, at 270, you are
saying with the acrylic, where mostly this region here is not of importance or
absorbed?
MS.
MILLER: It would be absorbed by the
acrylic.
MS.
KANTNER: By the acrylic. So, in this region, at 270 up to this
region, is this the area that is emitted by these bulbs?
MS.
MILLER: Out into the visible also.
MS.
KANTNER: Okay, so up into this region.
MS.
MILLER: And it keeps going. There is even some infrared emitted by the
lamps, but as far as the biological effects, this is the region of most
interest to the skin.
MS.
KANTNER: Thank you.
DR.
ROTHENBERG: Any other questions? If not, could we go back to that list then
and let's consider the different requests.
I think there is enough discussion that we should consider these one at
a time rather than as a group.
MS.
MILLER: Do you need me to go back and
show each detailed slide or not?
DR.
ROTHENBERG: Well, we have these in
front of us, so if we just go to page 4, the bottom slide, Proposed Revised
Label.
Any
comments that anyone on the committee wants to make?
DR.
LIPOTI: To me, the most important piece
of information that I got today was from what Howard Cyr said, and that is that
the body that determines what is a known cause of cancer, the Toxicology
Institute, has classified ultraviolet radiation a known cause of cancer.
It
was not on any of the slides, it was not in any of the presentations, but that
is an extremely important fact that I don't think the FDA, as another body of
government, can ignore that classification.
Therefore,
I would make a motion that the warning label be changed to say,
"Ultraviolet radiation is known to cause" and continue on as written.
MS.
MILLER: Howard is not here. I was going to refer to him. I would agree ultraviolet radiation has been
shown to cause skin cancer, but I would say that the jury is probably still out
on whether ultraviolet radiation from sunlamps can cause at least
melanoma. Probably you could assume
that it will cause squamous cell given the right circumstances, but I think it
is not a proven fact that sunlamp exposure will cause skin cancer in everyone.
DR.
LIPOTI: But the warning label
specifically says ultraviolet radiation, it doesn't say sunlamps. So, therefore, to properly characterize what
the Toxicology group has done, I am using the exact term, "known cause of
cancer," so I am saying is known to.
MS.
MILLER: Yes, I think what we probably
should do before changing the language is look to what is done in the tobacco
industry, because I believe that they also use the language "may
cause," and there may be some compelling reason to do that, and I think if
it is done for cigarettes, we probably can't make a stronger statement on
sunlamps.
Howard,
we have a comment on given the NTP's recent publication, we should change the
warning label to say "Ultraviolet radiation is known to cause skin
cancer" blah-blah-blah. Do you
have an answer for that?
DR.
BEER: [Off mike.] I would simply say causes.
MS.
MILLER: Simple.
DR.
LIPOTI: I can live with that.
MS.
MILLER: We will definitely consider
that.
DR.
ROTHENBERG: I have one question I am
not clear on. One of the reasons we
changed or you are proposing to change from Danger to Warning was for the
harmonization. What does changing these
other wordings have to do with harmonization?
I am not clear, what is part of an agreement with the other
organizations, the international organizations, and what is not.
MS.
MILLER: I would say the entire label,
as you see it there, is a reproduction of what is in the international standard
except for the Consult your Physician phrase, that is not in the international
standard.
The
language in the international standard was developed with our participation
using the information that we have in our current standard and with the intent
of shortening it and simplifying the warning.
As
far as using Danger or Warning, they use Danger right now. If the committee feels strongly that the
word Warning should be there, we could present that to them at our next meeting
in April of 2004.
DR.
CYR: Tom was suggesting that I amplify
a little bit more on what the NTP report was.
It's a Report to Congress, and they did look at all sorts of data
involving sunlamps and skin cancer, but it was older sunlamps or different
kinds of sunlamps.
They
are sunlamps that were used at home, sunlamps that gave severe burns, and
things like that, so it not the controlled, modern-day sunlamp system that we
are dealing with here exclusively. The
data has complications in it.
The
other thing is that they have made that assertion of known cause, but they said
nothing about the magnitude of the risk, and they explicitly left the
determination of how much actual risk was involved with sunlamps as they are
used now. They leave that up to the
various agencies like FDA to go ahead and do their own risk assessment.
As
I said, there are other groups that don't agree with the NTP conclusion. They thought that it shouldn't have been
quite as strong as it was.
DR.
LIPOTI: Are there other government
agencies that don't agree with the NTP?
DR.
CYR: I am not sure that too many other
government agencies have a major stake in this. I mean EPA has to a certain extent in activities involving ultraviolet,
but this was a comment on sunlamps per se.
I think we are the key players here.
I
have tried repeatedly and unsuccessfully to talk to NTP and have done it very
recently because I want to discuss these things in great detail. I wasn't there when the decision was made,
and there are obviously many issues that I would like to clarify and get some
more information on.
I
have found out within the last day that I would be successful in my attempts,
and so hopefully, within a couple or three weeks maybe I will better understand
where NTP is coming from, and they will understand better where we are.
MR.
KACZMAREK: Joe, did you want to say
something?
MR.
LEVY: Yes, thank you.
I
think if you also look at the document, the NTP document, that does not take
into account dosage at all, which makes it about--I would like to say
this. I would like to say that to say
that UV light is a carcinogen and therefore should be avoided is akin to saying
that water causes drowning and therefore should be avoided.
It's
a mischaracterization of the relationship, and this document seemed to foster
that since dose was not taken into account at all, and as Howard mentioned, it
doesn't take into account the equipment we use today versus what was used in
the studies that they looked at, which had divergent conclusions with some of
the work that CDRH has done.
DR.
ROTHENBERG: Dr. Mabuchi.
DR.
MABUCHI: The International Agency on
Research for Cancer has a series of monographs classifying carcinogens into
established or potential, et cetera.
There are two monographs on the UV radiation. I don't know what wording they use, but I guess may look at that
and see what they say about the definition.
MS.
MILLER: We have seen those
documents. I can't tell you right now
exactly what the language is, but we have looked at those, and I believe it is
very similar to what has been adopted in IEC, because the people on that
committee also referred to those documents in their work.
You
don't have enough copies? IARC
International.
DR.
BEER: I took part in the development of
this document, as a matter of fact, 11 years ago. The group that developed the document recognized that UV is known
to be a skin cancer-causing agent, but there was no data that would directly
link sunlamps to cancer, so the wording is sunlamps--I am trying to reconstruct
it--"sunlamps are probable cause of skin cancer," but everybody
agreed that UV, whether it comes from the sunlamps or the sun or whatever else.
MS.
MILLER: I guess it is just a question
of how the product is used and the doses involved, and it's complicated.
DR.
ROTHENBERG: To get back, Dr. Lipoti has
recommended that we--I am not sure now--was it that we take out the word
"may"?
DR.
LIPOTI: Yes, I accepted a friendly
amendment to say, "Ultraviolet radiation causes."
DR.
ROTHENBERG: But at one point we had
"is known to cause."
DR.
LIPOTI: That was my original
recommendation, but Dr. Beer suggested simplifying the language.
MS.
MILLER: Could I say one more
thing? I think what you are getting at
is you want to get the message across that ultraviolet radiation is known to
cause skin cancer, but the way the label is set up right now, we have those
three bullets there, injury to the eyes and skin, skin aging, and skin cancer.
At
least as far as the first one, which refers to acute effects, I don't think we
really have a strong of a case that it is known to cause burns, for instance,
at least not in all cases.
DR.
BEER: I would like to add one
clarification, anything that we can change in the current text can be
communicated to the IEC and request that they change their text at the next
edition. IEC has a faster cycle of
changing, amending, and every four or five years, there is a new edition of this
standard. We are part of this process,
and we can change it.
DR.
ROTHENBERG: Dr. Benson.
DR.
BENSON: We had added a phrase about the
protective eyewear, instead of provided, wear eyewear that is federally
approved for use with sunlamps or something to that effect?
MS.
MILLER: I have no problem with
that. I think that is a good idea.
MS.
KANTNER: I think there was also some
discussion about expanding on the, "Consult a physician or
dermatologist," I think would be something that we would want to consider
on expanding on the label, possibly prior to use, possibly because of the fact
maybe a dermatologist or pharmacist, I would lean to possibly a dermatologist
possibly assisting and providing more information or direction.
Is
there any suggestions of preferability on expanding that?
MS.
MILLER: Well, we prefer to keep it as
short and simple as possible, but I think, in principle, it's a good idea to
alert people that maybe they should see a dermatologist if they have specific
questions.
However,
a lot of this information, at least with regard to medicines and
photosensitivity, is widely available, and I think most physicians should be
aware of the PDR, and that is where the information is. So, it's not inconceivable that a primary
care physician could advise people on which medications might be
photosensitizing.
That
is a very kind of gray area. There
isn't a lot of data on the numbers of people that will be affected by
medicines. It is usually very low. So, even if you are taking a medication that
has been shown in a few cases to be photosensitizing, chances are it is not
going to be photosensitizing in your case, so it is kind of a complex issue.
I
know we could add the dermatologist, but I don't know if it is really gaining
us much as far as the safety is concerned.
What I am saying is the primary care physician should be able to provide
that kind of information.
DR.
CYR: An additional comment. So many of these comments have dealt with
the international standards, harmonization, and, in particular, the IEC. Industry has been a member of IEC, but
industry from Europe. They have no
American industry representatives on there.
We
discussed this at one of our meetings before and suggested, and I guess I had
offered an opportunity for the American industry to participate in this. I think there is some reluctance on the part
of the industry because it is sort of like they disagree so much with them
right now that they perhaps didn't want to participate.
But
maybe we should suggest again that the industry be a part of this IEC process
and maybe some of these things can be worked out before they land here. They could deal with them directly, and we
wouldn't have to be the intermediaries with issues which are IEC sort of
issues.
MS.
MILLER: Actually, just in the past six
months, a member of a U.S. company, has been made a member of the IEC
Committee, so hopefully, in the future, you will have more.
DR.
PLATNER: One of the problems I have
with that is that just the cost of traveling to those meetings really is
prohibitive for any consumer group or worker group or nonprofit from the U.S.,
so it does limit participation.
MS.
MILLER: That's true. What is why it is nice that the FDA standard
is more accessible to people, you know, the common person making comments
because it doesn't require traveling to a meeting, you just submit your
comments after the notice is published in the Federal Register.
DR.
ROTHENBERG: Is there a comment?
MS.
BARR: My name is Helen Barr, FDA. I just wondered if we could consider
something like consult physician or product labeling. We might check with our own Colors and Cosmetics and Drug
people. I believe if there is a known
sensitivity with sunlight, it would be included in--you know, it's on the
prescription bottle like with erythromycin and in the labeling of cosmetics,
but we might want to consider that and check with our own folks.
MS.
MILLER: That is a good idea. I am not sure if a huge range of products
are labeled that way, but I am sure some of them do have warnings about that. Of course, that makes the warning label
longer.
MR.
KACZMAREK: Sharon has to leave shortly,
and we have these other points to discuss.
You wanted to say something, John, but then I am wondering if we can get
the committee to say whether they like this label or don't like it, or to be
neutral on it and that the Agency should work on it some more before they can
say whether they really like it or don't like it.
DR.
CARDARELLI: Then, I will make my
comments extremely brief. One, I do
like the language provided by ITA especially about wearing the
federally-compliant eye protection statement.
I
do like the addition of unprotected eyes, and I would also add the word
"skin." It is okay, in my
opinion, to leave out "avoid overexposure" based upon your earlier
comment, Sharon.
The
other thing is I agree with Dr. Lipoti's position on addressing or
strengthening the question. I would
like to see some consistency with the lamp manufacturers and the warning label,
and IEC, whether or not we use Danger or Warning, just consistency.
Finally,
since this is being discussed, it would be helpful, I think, for the consumer
and public health interests if you would just put a bullet on here, as well, to
the FDA web site where the consumer can now go and learn more by themselves, so
something to consider.
MS.
MILLER: Are you referring to something
like that list of medications?
DR.
CARDARELLI: No, I am saying for further
information, see www.fda.gov, and then lead them to an FAQ, which all these
issues could be addressed.
MS.
MILLER: When the label first came out,
there was no such thing.
DR.
CARDARELLI: Yes, I understand.
DR.
ROTHENBERG: I think we have got enough
discussion here that maybe you should go back and review all the comments and
maybe come up with a revised label.
MS.
MILLER: I would just like to say one
thing. If you decide to either approve what we are doing or tell us to go back
to the drawing board, that this is a proposal and that once it comes out in the
NPR, there is a period for comments, and we have to address each comment at
that time before we come up with a final version, so those minor things,
wordsmithing can be worked out at that time.
I
think, you know, we have been here several years now presenting similar things,
and because of minor changes that people have, we are not making any progress,
so I think, if possible, we would like to at least hear from you that this is
very close to what we want and that the fine details can be worked out in that
process.
MR.
KACZMAREK: What she is saying, I was
just going to say that, that the way it is printed out in your handout here is
not necessarily the way it would appear in the Notice or Proposed Rulemaking
because there would be further wordsmithing, whatever you want to call it,
before we would publish it.
MS.
MILLER: But we certainly would consider
your comments especially regarding whether we put Danger or Warning, and we
want to be consistent. I do like the
recommendation of specifying that it be federally compliant eyewear, so we
would include that as a change, but as far as the "may" cause and
"causes," I think we still have to discuss that, but that would be
something that would also be open for change after the comment period.
MR.
KACZMAREK: So, should we pass on this
one and go to the next one?
DR.
LIPOTI: I guess if I read the charter
for what TEPRSSC does, you really just have to consult with us, we don't need
to approve the wording or anything. I
think you have heard our comments. We
are supposed to provide advice and consultation on technical feasibility,
reasonableness, and practicability of performance standards, and I think we
have.
MR.
KACZMAREK: Good.
DR.
ROTHENBERG: Is there anyone on the
committee who is not comfortable with proceeding in that fashion with regard to
this first proposal with the warning label?
I
think you have gotten our sense and let's now move on to the next proposal,
which has to do with including the warning label into the catalogs. There was discussion and reply from you, I
believe, that it was most important for the consumer rather than the salon and
industry people who are already aware of this.
So,
then, you would proceed with adjusting that recommendation?
MS.
MILLER: Making it a subset, you know,
specifying that only advertising marketed to the consumer would require that.
DR.
ROTHENBERG: Can we assume that that is
the sense of the committee and move on to the next proposal, which is who
becomes the manufacturer issue?
What
comments do people have on if we go on to the next couple of slides before
Amendment 4, the two slides, that modification, what is the sense that we want
to give to the people, our presenters from the FDA concerning manufacturer
definition?
DR.
CARDARELLI: Can I make a quick comment?
DR.
ROTHENBERG: Sure.
DR.
CARDARELLI: The information I learned
from the presenters today was very helpful regarding this issue, and one I
think of particular interest that I found was even though you might change,
say, a ballast, that could change the entire output of the lamp, so right now
it is all directed towards the lamp issues.
If
you do change anything else that affects the lamp output, that is an
issue. Someone mentioned about
specifically addressing if you change a plug here or there, as long as it
doesn't effectively change the lamp output, I have no problem with that, but a
ballast could. I didn't know if that
was going to make a difference or not.
MS.
MILLER: I feel that the way that it is
worded covers that because it does say that if the modification affects any
performance aspects, that there is an applicable standard in the section that
you have to recertify the product, and the output would clearly be one of those
significant modifications.
DR.
LIPOTI: I guess that gets to my
question about the timer. In one of
your slides, you say, "Examples of significant modification might be
increasing the maximum timer setting," but I really don't see in your
standard anything to do with the timer.
When
I asked you about the timer's tolerance, you said, well, no, that's in the
guidance document.
MS.
MILLER: Yes, I was wrong about
that. Actually, the old standard does
have, one of our Compliance people reminded me, that there is a 10 percent
limit on the accuracy of the timer in the current standard.
DR.
LIPOTI: There is.
MS.
MILLER: Yes.
DR.
LIPOTI: And that would not be changed
by your proposal?
MS.
MILLER: Right, we would still have that
in there.
DR.
ROTHENBERG: So, where do we stand on
the significant--is everyone happy with that wording, "significant
modification?"
DR.
PLATNER: I just had one question. It is still not clear to me that this would
cover importers who might then relabel or label initially a product that is
coming in from Taiwan or something like that.
The
manufacturer is really outside of the reach of U.S. regulations, so it seems to
me the importer needs to carry that burden in some way. It is not clear to me that is covered.
MS.
MILLER: That is probably in a separate
part of the standard that says something like any importers have to meet all of
these same requirements. I mean it
certainly is covered in the standard that anybody who wants to market in the
U.S. has to meet the same safety requirements and labeling requirements, so I
don't think you have to worry about that being a problem.
DR.
ROTHENBERG: I didn't hear any concern
about that issue. It was only about
specific details of what the tanning people might do in their own salons, some
minor maintenance, and so on, would that make them a manufacturer, and that
doesn't seem to be the case.
MR.
KACZMAREK: So, the committee endorses
that.
DR.
ROTHENBERG: The committee endorses the
basis of it.
The
next one has to do with the revisions to the eyewear requirements, No. 4,
including I guess the bottom of page 6 and the bottom of page 7, the two limits
on the visible region.
MS.
MILLER: One of them is the floor, and
the other one is a cap.
DR.
ROTHENBERG: Is there any comment on
this?
DR.
LAMBETH: I assume that in the actual
document, that the criteria for measuring the transmittance bandwidth will be
put into it.
MS.
MILLER: Yes.
DR.
LAMBETH: That is what we were talking
about earlier.
MS.
MILLER: Right, I agreed to that
before. We will make that a part of the
record.
DR.
LAMBETH: It is not just part of the
luminance transmission.
MS.
MILLER: But also the UV, right.
DR.
LAMBETH: Part of the spectral
transmittance.
DR.
ROTHENBERG: Any other discussion on No.
4 with the eyewear?
The
next would be the Amendments 5A and 5B where we did have significant discussion
about these items. What comments do
people have as we consider where to go with this?
Let's
look at 5A, replacing the erythema action spectrum with the CIE reference
action spectrum.
DR.
LAMBETH: Before you go on, the cap on
the spectral transmittance also, I understand why you were putting it in, but
it seems like the whole objective there is to enable the user to see.
MS.
MILLER: That's not the objective of the
cap, that's the objective of the floor.
DR.
LAMBETH: The visible part of the
spectrum, I mean from a pragmatic standpoint, I assume the user, if he can't
see anything, he takes the darn thing off, the goggles off. That is what we really want to avoid is them
taking it off.
So,
having the 5 percent cap on it, your feeling is that the 5 percent really
allows you to see well enough.
MS.
MILLER: We had this discussion last
time. I would say that our lab has
tested probably just about every type of eyewear on the market, and 90 percent
of them can meet the 5 percent cap with no problem.
There
is just one manufacturer that I am aware of that has a product that cannot meet
the cap, and obviously, this eyewear has been used for years, and no one has
ever had a problem with seeing through them, so I don't think it is going to be
prohibitive.
DR.
LAMBETH: I am saying 5 percent, I am
saying why, you know, this is a person, 550 nanometers is actually beyond the
peak sensitivity of the eye, right in that region, where we can really see
really well.
MS.
MILLER: Around there.
DR.
LAMBETH: So, it is sort of like, okay,
at that point we are dealing with sunglasses here, if there were other room
lights on, right? If I put the goggles
on before I get into the suntanning, I want to see as I walk across the room,
and that sort of thing. I would like to
have something that actually was quite transparent at 500 nanometers.
MS.
MILLER: I don't think people put them
on as they are walking around because most of them don't say on by themselves,
they only would stay on when you were lying down, so I don't think that they
put them on until they are lying in the bed, but someone else may have an
argument about that.
DR.
LAMBETH: I just don't understand why we
are capping it at 500.
MS.
MILLER: I think Joe Levy can answer
that.
MR.
LEVY: Most them are held on. Generally, they are put on, then, the person
lies down and turns the bed on, so they are put on right before.
DR.
LAMBETH: But not walking around.
MR.
LEVY: It is not to say that they
wouldn't be, but generally, you are probably right next to the bed, but you
could be walking around with it.
DR.
LAMBETH: Let me rephrase my
question. I am still trying to
learn. Why do I want to prevent you
from being able to see at 550 nanometers when the lamps themselves are not
putting out any light out there of any harmful radiation, is it just to
protect?
MS.
MILLER: Well, as I said before, in the
typical fluorescent lamp type of bed, we don't feel that the visible light
levels are harmful to the retina, but in the situation where you have a high
pressure lamp that are small source sizes, and so forth, that is why we want to
limit eyewear for those products, but the other, the forthen [ph] beds, eyewear
for those wouldn't have to meet the 5 percent cap.
DR.
LAMBETH: All right.
DR.
ROTHENBERG: Wayne.
MR.
MYRICK: This also pertains to
eyewear. I think we need additional
wording to give alternatives to a tag, possibly direct labeling on the goggles
or protective eyewear, or even possibly color code, but there need to be
something that could be more permanent and an alternative.
MS.
MILLER: The wording could be probably
improved. My first thought was to put
something on the wording, for example, do not use in high pressure beds that
contain high pressure lamps, but then that doesn't give an alternative to the
user, what should they, should they just not use anything.
We
are trying to keep it short and yet give the information that it is not
appropriate for those types of products.
MR.
MYRICK: I wasn't referring to the
actual wording, but an alternative to a tag that would be attached to.
MS.
MILLER: I think that is a great idea,
color coding, and that could hopefully be adopted by the industry, and they
would be able to explain it to their users.
DR.
ROTHENBERG: We could take a brief
comment from the back.
MR.
ENGLISH: My name is Bob English. I am a salon owner from Pennsylvania. If there is only one type of eyewear that
doesn't meet this criteria, why couldn't it just say on that particular brand,
"Not approved for high pressure" - period, end of the story, simple,
simple for a customer to understand, simple for a salon owner to understand,
and simple for manufacturers to understand.
MS.
MILLER: That's the whole intent is that
eyewear that can't meet the cap would have that label on there, so I think we
are saying the same thing basically.
DR.
ROTHENBERG: I think we have addressed
that concern. Can we go ahead then with
No. 5A, the question of the action spectrum.
Yes.
DR.
CARDARELLI: One thing, it is more of I
guess a recommendation because this is just mainly a proposal that will go out
for further comment, is that we engage also in some discussion with the
American Conference of Government Industrial Hygienists who also have threshold
limit values, and use a spectrum. I am
not exactly sure if it's the same exact one that you are proposing to change
to, or if it is the version you are changing away from.
MS.
MILLER: It is neither actually. It is the spectrum that the ACGIH uses is
probably closer to the non-melanoma skin cancer action spectrum, but it is not
identical.
DR.
CARDARELLI: Okay. So, there might be some issues, if we are
going to go to the harmonization issue, not only international, but we ought to
engage our scientific associations here in America, and ACGIH would probably be
a good place to start.
MS.
MILLER: I don't know if you are
familiar with Dr. David Sliney [ph], who has been probably you could say he was
the father of the ACGIH action spectrum, he has been working with us very
closely at least developing standards, and he has had a lot of input to the CIE
Committee who approved these action spectra.
DR.
CARDARELLI: That is good to hear.
DR.
ROTHENBERG: Is everybody happy with
that, seek some further interaction before making a final decision?
MR.
KACZMAREK: Should we go ahead and
replace "currently used" with the internationally accepted CIA
reference action spectra? Yes?
DR.
ROTHENBERG: How many are in favor of
the proposal? How many opposed? I am going to abstain. I am still confused.
DR.
CARDARELLI: I abstain.
DR.
ROTHENBERG: It seems like the majority
of the committee says to replace. There
is also some guidance to maybe have some further discussions before making a
final decision.
MR.
KACZMAREK: It will be published for
comment.
DR.
ROTHENBERG: Part B of No. 5, I guess
use the new definition 200 joules per
square meter, then, go to 3, so that the maximum will be 600, which would be
similar to the 624 effective.
MS.
MILLER: Right, actually, a little
lower.
DR.
ROTHENBERG: Basically, you want to
retain an equivalent.
MS.
MILLER: Yes, that's what we were trying
to do. It's equivalent dose really,
biologically effective dose.
DR.
LAMBETH: I guess the question that
comes out of this being equivalent, is there any evidence that would say that
there are any currently manufactured beds which would not be satisfying the new
requirement?
MS.
MILLER: Since they are so similar,
there is a limit on the measurement process as far as accuracy goes, I can't
see that any products that meet the current 4 MED could not also meet the new 3
MED.
DR.
LAMBETH: One of the arguments is from
the standpoint that the old system is a little simpler to actually
characterize, so if I satisfy the old system, do I satisfy the new system?
MS.
MILLER: Well, it's not really any
simpler, it's just a different weighting curve you are using. But, yes, that was the goal, to keep
everything, so we are delivering the same biologic dose.
Actually,
in our studies that we are doing currently on exposure schedules, we have found
that we are using a new 3 MED value, and as you let people build up to that
dose level, it allows them to get a tan without burning and yet it is also very
sufficient to produce a tan.
DR.
ROTHENBERG: The question seems to be if
someone has an existing system, do they have to change anything, or are we just
changing the definition?
MS.
MILLER: No, because for one thing, when
the regulation changes, it only applies to new production. Also, biologically, a system that met the
old definition should be able to meet the new definition.
So,
if they are making, you know, a certain bed, they shouldn't have to change
anything on it.
DR.
LAMBETH: I am a little confused about
that, because it looks like they have to change the maximum limit on the timer.
MS.
MILLER: The way it is calculated is
changed, but the actual time that would be required to produce that dose would
not change. So, you would take your
measurement of the spectrum, weight it with the new action spectrum, and then
calculate how much time is needed to reach a certain dose, and that dose is
basically the same as it was in the old system, so the amount of time required
to deliver that dose is also the same.
DR.
BEER: I would like to add one piece of
information. This number 200 joules per
meter squared is based on experimental work done in France and in our lab, and
we selected the dose that would represent the most sensitive person that could
use tanning equipment, so this number is very carefully selected on the basis
of hundreds of measurements.
DR.
ROTHENBERG: Yes.
DR.
PLATNER: I just wanted to say that it
seems to me that if you take both of these amendments together, they are
acceptable, at least from my point of view, but if you only change one or the
other, then, it's a problem. So, voting on them separately is a little bit
awkward.
DR.
ROTHENBERG: Right. So, they should be considered together.
MS.
MILLER: Yes, that is why I grouped them
A and B.
DR.
ROTHENBERG: They should both be taken
together. Is there any other comment on
No. 5? I think we are then telling you
to proceed.
No.
6 is the coding scheme and the X and the Y, and the reflector codes, et
cetera. The reflector codes are the
same or these are new?
MS.
MILLER: It's kind of based on improving
what is currently done. Right now there
is no requirement for how the reflector design is specified. You saw the lamp that had the R on it. Since there is no industry definition of
what that means, it is going to be an improvement in the system, I think,
because it does make a difference on the output how the reflector is defined.
DR.
ROTHENBERG: Have there been any
discussions? I don't believe we had
anyone here representing the lamp manufacturers.
MS.
MILLER: No, but this system, which was
presented at the IEC meeting in June, was proposed by the group of lamp
manufacturers, because I personally and a lot of people don't have any
experience.
DR.
ROTHENBERG: So, they don't see a
problem--
MS.
MILLER: No, this was their system
actually.
DR.
ROTHENBERG: --in achieving this
labeling?
MS.
MILLER: No.
DR.
ROTHENBERG: There is a comment in the
back?
MR.
DUVANEY: My name is Jerry Duvaney
[ph]. I work with one of the largest
manufacturers of commercial tanning beds in the world. One of the things about the lamp replacement
thing, nowhere do I hear anybody saying that the lamp should be tested in the
piece of equipment it is intended to go into, because the tanning bed directly
impacts the output of the lamp.
So,
a lamp can be tested on the bench test and give totally different output when
it goes in the tanning bed itself, and nowhere do I see anybody saying, hey,
let's put it in the bed and then see what the results are. That is one.
The
other thing is you say it must be within plus or minus 10 percent of the
original lamp. I can understand being
too strong, but on the one hand, you want to put language in that says it
causes skin cancer, on the other hand, you are saying but you have to give so
much output, so you are kind of contradicting yourselves there, too. So, I just think we should be more uniform
on this whole thing and require that the lamp be tested in the bed it is
intended to go in before you say, hey, let's put a code on it. That's it.
MS.
MILLER: I would just to say that we
have talked about this with bed manufacturers, lamp manufacturers, state
inspectors, lots of people we have had meetings, and if you really, I guess in
a perfect world, you would like to test an individual lamp in any bed it could
possibly be used in, but that's just not really practical, I don't think.
The
theory we are operating on is that if a single lamp measured by itself in a
non-reflective environment was standard procedure as far as the way it is
driven, and temperature, and so forth, if it has a certain output under those
conditions, and another lamp also has the same output under those conditions,
it should behave very similarly in the final product.
I
think that is the best we can do as far as guaranteeing that they are going to
perform the same, because, you know, the reality is the lamps have to be
replaced over time and the original lamp might not be available, so you have to
find a substitute that has not been tested in that specific product.
DR.
ROTHENBERG: So, the concern is not
really whether you take that lamp and put it in tanning bed A, it will give the
same output as in tanning bed B. It is
if you replace the bulb in tanning bed A, is tanning bed A going to behave the
same way.
MS.
MILLER: Right, and I think the answer
is yes.
Then,
his other comment about the plus or minus 10 percent, you know, we of course
want to ensure that the replacement lamps don't create a safety problem, but we
also don't want to cause a problem for salon owners, so that they will replace
the lamp and it will be so much less effective than the previous lamp that the
consumers will start complaining.
So,
we are just trying to make sure that the performance both from the aspect of
safety and tanning efficiency remains about the same.
DR.
ROTHENBERG: Dr. Lipoti.
DR.
LIPOTI: I do think that this does raise
the importance of that SOP for lamp measurements. You mentioned that it is currently undergoing revision. I am assuming in the four years before you
finally adopt the standard, it will be ready to go, but I think that is
critical to the success of the regulation, it's how you determine compliance.
MS.
MILLER: But as we said, that is an IEC
standard and their process for revising standards is much faster. They have a meeting, someone writes it up,
and it goes out for comment, and gets voted on. So, it could be less than a year.
DR.
LIPOTI: I guess then that brings in the
point of how do you reference the IEC standard in your regs, will you reference
the most recent revision of IEC Standard 1228, or will you reference IEC
Standard 1228 in effect in October of 2003.
MS.
MILLER: We will have some kind of date
there that makes it clear which standard we are talking about.
MR.
KACZMAREK: I think you were
specifically referencing number and revision number for an IEC standard, so
everybody would know which one you were talking about.
MS.
MILLER: When IEC standards are
published, they typically have a date or a version number or something like
that.
DR.
LIPOTI: Which then precludes fixing
them.
MR.
KACZMAREK: You would assume the process
for fixing it would be pretty rapid because you are really just making a
technical amendment to your reg, to update it.
DR.
ROTHENBERG: With that taken under
consideration, the standard procedure for testing, how many are in favor of
then providing guidance to go ahead with No. 6?
[All
in favor.]
DR.
ROTHENBERG: Any opposed? Abstentions?
[No
response.]
DR.
ROTHENBERG: I guess that's it. Thank you very much for your participation
and patience.
We
are now a little bit behind schedule, so what I am going to recommend that we
take a one-hour lunch break and try to start about 1:45.
I
take it we have completed all of the public hearing part of the sunlamp issue.
CDR
LOSCOCCO: I just have a question on
whether we need to have a motion that says go forward with all six proposals,
because we didn't really vote on the first set. Do they have to have that from
us?
MR.
KACZMAREK: My understanding was we were
going to consider more at a time individually.
DR.
ROTHENBERG: We basically concluded they
should go ahead, taking into account our comments on each, so we completed all
six.
We
will reconvene in one hour, at approximately 1:45.
[Whereupon,
at 12:40 p.m., the proceedings were recessed, to be resumed at 1:45 p.m.]
A F T E R N O O N P R O C
E ED I N G S
[1:50 p.m.]
DR.
ROTHENBERG: I guess we are ready to
begin with the afternoon session. Dr.
Tom Shope will speak on Proposed Amendments to the X-ray Standard.
Proposed Amendments to X-Ray Standard
DR.
SHOPE: I am Tom Shope from the Office
of Science and Technology. My purpose
here today is to update the committee on the proposed amendments to the
Performance Standard for Diagnostic X-ray Equipment, primarily to discuss the
comments we got on our proposed rule which was published in December of
2002. The comment period ended in the
spring.
I
can't give you the determination on what our final proposals will be at this
stage of the development process, but I can summarize the comments that we got,
some of the issues that we are currently dealing with as we try to proceed to a
final rule.
We
haven't reached final decisions on some of the issues, so if there are suggestions that the
committee would like us to consider, it is not too late for us to take those
into account as we do our final deliberations.
Just
as an example of what I am going to try to cover today, a little bit of
background for some of the committee that has not been involved in this, a
little bit of what we got on the comments, what we are currently dealing with,
then briefly when we expect to finish, talk a little bit about the role of
international standards, and then entertain advice and comment from the
committee.
As
background, the radiological community recognized that we needed some
amendments probably to the X-ray standard in the early '90s as technology and
clinical use of fluoroscopic X-ray systems specifically changed quite a bit.
We
saw increased radiation output capability on many systems and a lot of new
imaging modes were coming into existence that really said the approach that was
taken in the late '60s and early '70s, when fluoro was mainly a GI procedure,
needed some additional look.
The
advent of digital subtraction angiography, which was a very useful technique
using fluoro equipment that resulted in considerable increase in dose from
typical fluoroscopy procedures, lithotripsy systems came along where you were
using the fluoro to apply therapy.
A
number of manufacturers had fluoro systems that had quite a bit of output
capability due to increase in tube technology, sort of a follow-over from the
CT systems, so concerns about all these kinds of issues led the Center to be
concerned about these issues, as well as the rest of the community.
We
had sort of a landmark conference in 1992 to talk about fluoroscopy issues in
general sponsored by the American College of Radiology with FDA
participation. At that conference, we
had sort of a consensus that there is really a need for dose information by the
fluoroscopists using these systems particularly in the interventional area.
As
a result of that, we began to work on some amendments. Parallel to that, following this meeting,
there was a working group that developed an International Electro-Technical
Mission Standard 2-43, which deals with the safety of interventional equipment,
again defined by the use of the equipment, not its physical characteristics.
Parallel
to this, there was a lot of concern about radiation injuries particularly
radiation skin burns during some of the fluoroscopic procedures.
To
address these issues, we began first, in 1993, we had a proposed rule typically
or only to just address one aspect of equipment, and that is, we had a thing in
the standard that allowed a high level control mode of fluoroscopy which, when
activated, required continuous activation and it required an alarm to ring.
The
exposures, however, were unlimited during this mode of operation, and we were
seeing equipment with very high exposure rates, so we proposed a limit in 1993
sort of as the stop-gap or first step in this activity. That rule became final in 1995.
But
as we were working on this activity, we also saw there were needs for a number
of other amendments probably, and we began work on those. An Advanced Notice of Proposed Rulemaking
was published in '97. We discussed
concepts for our amendments with the committee in '97 and '98, and there have
been some updates since then.
Unfortunately,
the Y2K problem came along and some of us got rather involved in that, and sort
of delayed our work on the fluoro amendments.
However, finally, in December of last year, we published the proposed
rule, which I think the committee has copies of, and that was done following
our estimate for development of the various impact analyses and cost and
benefit estimates that were needed in order to publish a proposed rule.
The
comment period ended in April, and we have been in the process of looking at
these comments and trying to prepare to write the final rule since then.
Today,
I want to sort of summarize what we heard in the comments and some of the
things that we see perhaps that were suggested that we may need to address in
the future.
We
only got comments from 12 different parties, individual or organizations. You can see here the kind of individuals
that we heard from. In general, the
comments were supportive of our activity or generally supported the amendment
process that we had proposed although there were some quibbles and some
suggestions, and maybe some objections to some of the specific proposals that
we put forth.
In
fact, we got a lot of suggestions for changes and things that we didn't
propose. These are changes that people
thought we needed to look at in addition to the things that we had proposed. One of the problems with that at this stage
of the game is if we were to adopt some of those, we would need to do an
additional proposal, so that everybody would know what we were talking about
and have a chance to comment on it.
However,
a number of the comments for changes that we didn't propose can probably be
handled as the kind of changes that aren't really significant in terms of
establishing new regulatory requirements.
What they are doing is either clarifying definitions, making wording in
the standard that is not quite clear, that we will try to make a little
clearer, but there were some
suggestions for significant changes that we probably cannot do at this stage
without an additional proposal.
So,
one of the things we will have to be doing is looking at some of those comments
and seeing how they should be factored into our future work.
One
of the themes that we heard from a number of the commenters was this issue of
harmonization--which is misspelled here.
That is the idea of trying to make the U.S. standard not in conflict
with other standards, particularly the IEC standard that many of the
manufacturers are interested in, in the current environment.
You
can be different than the IEC standards, but you would hope in harmonizing that
you won't have requirements in the U.S. that directly conflict with something
that may be required by another group.
So,
what were some of the comments that we got?
We got a lot of comments about modifying definitions. In fact, we had proposed a number of
definition changes and additions. We
got changes, suggestions on things we hadn't thought needed changing, and we
probably looked through most of those and have decided in a few cases that it
will make sense to make a minor change here and there.
We
have added some definitions in our proposal and we have added a couple since
then. I will talk a little bit more
about those in a moment.
There
was a desire expressed particularly by the American Association of Physicists
and Medicine to have some additional consultation, perhaps even some conference
type work, with FDA, and these comments were mainly in response to some of the
questions we posed in the proposed rule preamble where these were not things
that we were proposing to do in this set of amendments, but ask questions about
should we consider, instead of having a limit on the radiation exposure or dose
rate to the patient or the input surface of the patient, should we instead
focus on the dose to the image receptor, what you are really interested in, in
assuring appropriate imaging performance, or should we do something on imaging
performance in general, is there a way
to tie that to exposure and have a rationale for exposure limits based on some
kind of criteria for imaging performance.
Another
issue that was suggested is that the new solid-state X-ray imaging devices that
we talked about may need additional things in the way of controls or standards
or measurement techniques that we didn't address in this particular standard,
and the medical physics community I think is interested in working on these
issues.
So,
those are some of the kind of comments that you could sort of put in the
category of these are future things that we are going to have to probably take
a look at, but I think there is interest in the community in working with FDA
on those issues should we decide it is appropriate to go forward.
Some
of the definitions that we got comments on and some of these we hadn't proposed
the change, but it was pointed out that we have something called an attenuation
block in our current standard. This is
a piece of aluminum that is put into the X-ray beam during a testing procedure.
We
specified both the size and the thickness of that block. It turns out the fluoroscopic imaging
systems now have X-ray field sizes that are typically larger than our defined
size of the block, so we need to make this thing bigger probably. It is probably just going to be changing,
instead of 20 by 20, make it 30 by 30.
As
soon as we do that, we will probably need to make it 40 by 40, but we are at
least considering should we modify this definition. There is a slight quibble perhaps on the thickness. We have 3.8 centimeters, the IEC has adopted
4.0, so we need to think about that.
It
is not a problem if you pass one test, you pass the other, it's okay to be a little
bit different like that, but we need to make sure that passing one test doesn't
put you in conflict with the other mode of testing.
Mode
of operation is one that has given us a little bit of cause for thought. We define mode of operation trying to
describe the various ways a fluoro system could be operated to require
information be provided to the user or to encourage manufacturers to describe
what that mode was intended to do, when you should use it, those kinds of
things.
Our
definition of mode of operation is a little different than the definition used
in the IEC standard for the similar concept.
In the IEC standard they have, a mode of operation is activated by a
single control, in other words, it's a one-button kind of selection that goes
on there, and if you can't do it with just one button, it somehow must not be a
mode of operation.
We
didn't want to restrict it in our proposal when we made it to that single
control mode, and I think we are still looking at those comments that we got,
but we will see how that plays out. We
think mode of operation shouldn't be limited just to one control, there may be
ways where selection of two ways of controlling the system, two different
features might put you in a particular mode of operation.
We
didn't have a definition in the standard of C-arm fluoroscopes and we are
putting some requirements on those. The
suggestion was made that we probably should define that, and we agreed with
that.
It
was suggested that we use the term "exposure" in the old, non-system
international or international system of units meaning of a quantity that is no
longer in favor, so we are making the change, of course, to go to air kerma or
kerma as a measure, but exposure has a second meaning which means activating
the X-ray tube.
The
suggestion was made that maybe we ought to include that because we want to use
both ways, so we are looking at probably implying that exposure also has a
second meaning. It is the meaning that
the IEC gives to the term "loading," which means loading up the
generator and making X-rays in the X-ray tube.
A
comment on the definition of isocenter, a little modification there. Some comments that our definition of
solid-state X-ray imaging device might have been a little more complicated than
it needed to be, and I think we are probably going to take those comments to
simplify that definition a little bit, to take out some of the prescriptive
kinds of words that might somehow limit the next generation of solid-state
image devices to fit the definition.
We
have a question about the definition of "visible area," which I will
talk a little bit more about later.
Then, there were a few other definitions, so there was a number of
things that we hadn't proposed that we got some comments on, and some of them
probably we will go ahead and be able to deal with as not requiring additional
proposals.
We
also got some critiques of some of our proposed comments. I think there was a mixture of comments
here. One of the concerns that seemed
to concern the users of fluoro systems was that we have a suggestion that in
describing the modes of operation, this is in the portion 1020.30 that deals
with information to be provided to users in the users' manuals, that
manufacturers describe the modes of operation, how you activate a mode and
really what the intent of that mode is.
I
think some of the clinicians reacted to that as by doing this kind of labeling
for the X-ray equipment, this would somehow limit their ability to use the
X-ray system as they saw fit, and therefore, they weren't exactly happy with
having manufacturers specify the intended use or the clinical task that a mode
of operation was for.
I
think we don't think that is going to limit the way users could use the
equipment, so that is one of the issues that we are currently looking at is to
how to make clear what we want to be in the users' information and how the user
who reads this information can relate that particular mode of operation to the
clinical task that I want to do with the fluoro system.
We
had some comments about the manner and accuracy of dose display.
This
is just a little cartoon that describes what we are currently proposing to
require, and that is that the user, while they are using the fluoro system, can
look up here and see a display of something related to the dose rate or the
cumulative dose at a particular thing called the reference point, which is
meant to be about where the skin of the patient typically would be, but, of
course, that is not a very precise thing, and this cartoon is not quite to
scale.
This
is meant to be the isocenter of the X-ray system, the point about which this
apparatus would rotate, and the reference point is 15 centimeters toward the
X-ray tube. This cartoon shows a line
here, but in real life it is probably much closer to the table surface in most
patients, the idea being that as this thing rotates around, this location would
be an approximate indication of the kind of radiation dose, air kerma, air
kerma rate reaching the patient.
So,
during the procedure, the radiologist or fluoroscopist would be able to see
that, see what kind of dose rates are being delivered instantaneously, and also
in our proposal, once he stops the exposurer would see a cumulative number
there.
Some
of the comments were--well, let me just say this would illustrate I think what
we were proposing in the proposal, and that is during a radiation, you would
see some kind of display, where this is on a separate little panel. It is shown
on the fluoro image down in the corner.
We didn't specify that sort of thing, but we were contemplating dose
rate information while active fluoro was going on and a cumulative number to be
shown at the cessation of exposure.
One
of the comments from some of the clinicians were we would like to see this
cumulative number all the time, not just at the end, so one approach to that
might be something like this that would have two displays that during fluoro,
active fluoro, you would see this number change and this number change. At the cessation of fluoro, this number
would go away because there would be no rate, but you would have the cumulative
exposure to that point during the procedure shown.
The
manner of this kind of display then is something that we are currently
considering how we should proceed.
Another
question was what is the accuracy of this dose display information. Our proposed amendments suggested that this
display be accurate to plus or minus 25 percent. We later learned, much to our
chagrin, for not having checked this beforehand, that the IEC standard has
requirements for display of air kerma rate, cumulative air kerma, dose area
product, and those are all specified basically with a plus or minus 50 percent
accuracy.
So,
one of the things we got comments on was we shouldn't use this, we should use
the IEC. I think there is some concern
about how useful is a plus or minus 50 percent kind of number if you are
interested in trying to track patients long term, one of the concerns or one of
the potential uses of this kind of dose display information, particularly the
cumulative dose number, is something that could be used in the patient record
or could be used in the concept of a reference dose level, which is a facility
can monitor over a period of time typical numbers and be able to identify outliers,
either procedures, physicians, particular equipment that are resulting in a
typical dose that is higher than usual and maybe compare those with national
norms if that kind of data can be collected.
So,
if the number is only accurate to plus or minus 50 percent, there are questions
about how useful that would be, so this is one of the issues that I think we
are going to have to reach a decision on, and comments from the committee, of
course, would be welcome.
We
are looking at what are the various things that could be involved in
contributing to this uncertainty, what are the factors. It depends on how this number is derived,
whether it is a measured or calculated or an inferred number, but I think there
is some feeling that probably this is clearly doable. This is just at the borderline perhaps and we need to come to
some decision on what is the best approach there.
Other
requirements. A proposal that what we
are really trying to do in this Section 1020.30(q)(2) was to say that users of
systems can have their systems modified.
In fact, if they want to get a system modified that currently exists,
and they want to add a dose display, if that ever comes to be possible, they
could do that to comply with our new proposed regs, and not have to worry about
the kind of certifications required if this is done by the owner provided that
the work that the owner has done for them doesn't lead to a noncompliance with
the standard.
Some
of the comments implied that we were expecting the owner, the physician or the
hospital, to take responsibility technically for this modification, and I think
our response is no, that is not really what we meant. We meant enter into a
contract with somebody that knows what they are doing and is part of the
contract, make sure they assure you that it meet specs when they are done.
We
would still hold the owner who requires this modification to be done is
ultimately responsible, but he should have some fallback to the person having
done this kind of a change.
There
are a number of potential reasons for making these kind of upgrades to existing
equipment that a current technical reading of the standard would sort of say
you can't do, but we want to make it specific that we do encourage upgrading of
some of these features like last image hold, dose display, perhaps even
collimation changes, and this change would make sure that that is understood
that that can be done.
Another
thing that we had some comments on were the issue of the audible signal during
fluoroscopy. We currently have a
requirement that has been in our standard and was adopted in the IEC standard
that came along later, a requirement that during fluoro, there is a timer that
can be set any period up to five minutes.
At
the expiration of that particular length of time, whatever was set, you get an
audible signal that sounds to tell the fluoroscopists that they have exceeded
that amount of fluoroscopy time. That
signal can be silenced by a reset and the fluoroscopy can continue.
This
does not interrupt the exposure, but it just allows a reminder that this
five-minute time period has expired or the four-minute, whatever they set.
We
proposed in our standard that this not be something that continues to sound,
but that it just sound periodically, not require a reset, and every five
minutes you get another sounding of this alarm just as a reminder that that
much time has passed.
We
also asked the question in our preamble would it be better to have this as
something that the physician using the system can set ahead of time. For instance, in many of the interventional
procedures, five minutes of fluoro is a rather short time, and being bothered
by the alarm going off every five minutes is more of an aggravation than a
help, perhaps this ought to be 15 minutes or 20 minutes.
I
think our comments came back where, no, that probably gets us into more trouble
than it would help in that people will set this for a long period of time and
the next user won't realize that and they may think they are going to get a
warning in five minutes and it's 20 minutes before they hear the warning.
Anyway,
this is an issue that we are currently looking at. If we were to proceed with our proposal, we will have a conflict
with the IE standard for X-ray generators 2-7, which prescribes exactly the
requirement we currently have, so our modification would require us to work
with the IEC perhaps to get them to make a similar change in the IEC standard
to do away with the fixed five-minute timer that has to be manually reset if
that would be the way we proceed.
We
also have a question about applying the requirements for dose display and last
image hold to what are referred to as mini-C-arm systems. These are the small, not necessarily
portable, but they started out that way, but I think now most of them are
mounted on carts, C-arm fluoro systems
that have a source-to-image receptor distance of less than 45 centimeters.
These
are labeled currently with a variance if they have this for extremity use
only. We had already proposed that
systems that are this small can have a different source-to-skin distance
requirement, but the other comment was that maybe these systems, because they
are used only on extremities, they are used in situations where we are really
not that concerned about dose and long procedures perhaps, that maybe this
expense of a dose display and a last image hold is more expense than worth it
here on these kinds of systems.
The
converse argument, of course, is that these can be used for interventional
procedures even perhaps if it's on an extremity surgery, those kinds of
things. We don't advocate it, but these
systems might occasionally be used in pediatrics.
So,
there is a question of whether we should include or not include the mini-C-arms
in the requirement for a dose display and last image hold feature. Most of these systems these days, in fact,
are digital systems and many of them, most of them, in fact, come with last
image hold, I suspect, although we haven't done a complete survey to make sure
there is no system that currently doesn't have last image hold.
So,
those are some of the issues that we are currently working through with regard
to this comment.
There
were a number of changes suggested for things we didn't propose, and I will
just briefly mention a couple of these.
One
of the questions or comments we got from several folks was that it would be
nice or you guys ought to require that manufacturers give information in tools
to the purchaser or to the medical physicist working for the purchaser or to
the repairman who comes in as a third-party servicer.
That
would facilitate troubleshooting, repair service, and testing. This was the range from things that would
help the serviceman to things that would help the medical physicists do
acceptance testing or periodic testing.
This
was not something we proposed I think to go this far. We need to thoroughly air such a requirement in a proposal
first. It is also not clear that these
things raise to the level of being radiation safety related directly that we
could actually include in a radiation safety standard although I think people
can make an argument that some of the testing is necessary and important,
whether we should make it mandatory that manufacturers provide this is still
for discussion.
One
of the driving forces for some of these comments has been from the service
industry, the third-party service industry, that find in this day of
computerized devices it is very difficult to do some of this servicing if you
don't have the secret passwords and the codes to get at some of these things.
What
we require in the standard is that the manufacturers have to provide to the
assembler, the person who assembles the X-ray system or puts it together
initially adequate information to allow that system to be assembled and tested in
order to assure compliance with the standard, so that kind of information is
required.
We
have just had some discussions about making clear that that includes computer
programs if that is the only way you can do it and that is the only way you
have described it for the service person or for the assembler, but if that can
be separated out, then, the manufacturer doesn't have to give anything else
other than that assembly instructions to complete what is basically the
manufacturing of the system.
So,
we have got that kind of comment. We
had several comments raised about the specification of the voltage wave form or
the kVp wave. This has to do with the
fact that there are a lot of different generators. Generators have changed over the years from systems that had
quite a bit of ripple in their voltage wave form to basically constant
potential generators, and some of the testing procedures that we have in our
standard, or that the IEC has, can be impacted by the voltage wave form that is
being used for the testing.
I
think we are comfortable that most of what we require is meant to be the way
the system is delivered, so it's the wave form the system puts out, not any
particular kind of wave form, but we are looking at this a little bit more to
make sure we are on firm ground.
I
think our inclination is no, we don't need to specify that, we don't need to
require that that be specified.
We
got a number of comments to use specific requirements from the IEC
standard. The suggestion was that we
use the IEC version of dose information, test procedures, and primary
protective barrier test procedure and limits on the primary protective barrier
transmission.
I
think there are some reasons not to attempt to put this kind of thing into our
standard, having to do a lot with the difference in terminology that is used in
the IEC requirements compared to ours.
We can't just plug them in because they use terms differently and they
are defined differently.
We
could do that, it would be I think somewhat confusing. We think probably we can deal with these
comments without having to go that far.
There
was a discussion or a suggestion from radiologists that, gee, this dose display
you are talking about is great, but there is a better way to do it, and there
have been some publications along these lines.
One vendor actually had a system for a while that did this, and this is
skin dose mapping. The idea is don't
tell me just the maximum dose or, excuse me, the cumulative dose or the dose
rate, show me where on the patient that dose is and how hot it is.
This
was a system offered by Siemen on a previous version of their interventional
X-ray system. This is basically meant
to be a picture. Here is the patient
lying on the table. This is their
abdomen and it has been folded open here, so you have this map of the
skin. So, this is the back shaded, and
this area is the front surface.
During
a fluoro system, this display is presented to the radiologist although I think
in the Siemen system it wasn't out where the radiologist was, it was back at
the control console, but you got an idea of the hot spots on the skin being
developed from this cumulative exposure.
This
is really I think for interventional procedures would be a real nice thing to
have. Apparently, there wasn't a lot of
demand, and the manufacturer that provided this feature didn't on its last
iteration of this system as I understand it.
Anyway,
that is the kind of dose display that some of the radiologists said would be
beneficial to have. I might mention
that FDA is supporting through a small business innovative research grant the
development of a similar kind of approach that might be an add-on to a system,
and we will have to see how that plays out in the future.
Another
comment we got was it would be useful if we could see where the collimators are
adjusted or, in other words, how large is the X-ray field without having to
step on the pedal and make irradiation, in other words, have the computer
display on the image display where the collimator blades are located.
There
are some systems that have such a feature.
I think the radiologists were telling us this would be really nice to
have, too. It would allow a collimation
adjustment deciding on how big to make the X-ray image without actually
exposing or you could make a quick exposure and while viewing that last image
hold image, adjust the collimators to the size you really need to see and then
begin your irradiation lab time.
Again,
something like this would be a step up for a lot of X-ray equipment and would I
think require a proposal in order to get there with comment from the public.
Another
question that came up was something we didn't propose, and that is, you know,
in radiographic systems, the exposure comes on, you see the needles jump or the
lights flash, and you know exposure is terminated when you hear the little ding
that goes ding.
But
in fluoro, I think the assumption--and we have no requirement in our standard
that there has to be a display of when the fluoro is on, because previously,
you looked up at the monitor or you looked at the II output and you could tell
the X-ray was on, but nowadays, with the last image hold and multiple monitors,
there is a concern on the parts of some of the commenters that we really can't
tell in this busy room exactly when there is X-rays being made and when there
aren't.
We
didn't propose a requirement like this, and this is one that I think we need to
look at perhaps. In the IEC standard,
there is a requirement that there be an indicator on the console out in the
control room when fluoro is on, but there is not an indication of a requirement
that there be a clearly visible and unmistakable indication that the X-rays are
being made out in the procedure room.
There
is a requirement in the IEC standard that they provide a means whereby somebody
could hook up a light or an alarm that does provide a signal when the beam is
on, but it doesn't require that that signal be fed to some display out in the
operator's room. So, that is a comment
that we got, as well.
The
last one is a little bit complicated to try to explain, but I will give it a
shot here, and that is the idea that in this day of digital imaging, a concern
was raised that it is hard to tell if the technologist is really doing a good
job of limiting the X-ray field when there might be the capability of adjusting
what you display after the fact, in other words, what we refer to maybe as
image cropping or electronic cropping of the final image.
This
is probably more of an issue in digital radiography rather than in fluoroscopy,
and I think it is something that we will have to think about. I haven't heard a lot of discussion of this
in the community, and I am really not clear as to how many systems this is a
capability on currently.
It
involves the marriage of the digital image capture and some ability to
manipulate that image prior to storing it or prior to storing it and then
bringing it back later to look at it, and we haven't really done a clear
investigation of what is out there, but let me sort of show you what I was
trying to get at here.
The
idea being that in a digital image receptor, let's think of it with a flat
panel perhaps, here is the image receptor, and good radiology practice would
limit the X-ray field to smaller than that, so you don't waste X-rays, but
perhaps you are only interested in this portion of the image.
This
is where the real information is. It
would be possible following the exposure, made what we would say with good
collimation conditions, that if you are worried about storage of lots of data,
you might only want to store this much.
Then, when you bring that image back later, you see the stored image,
but you really don't have any idea of a way to tell how big the X-ray field
was.
On
film currently, you can see the edge of where the film blackening was and know
the technologist used good collimation.
This is a concern if the equipment would provide a feature like this
where here is your image receptor, the solid-state device is only so big, but
in order to make sure I don't miss anything, I open up the X-ray field a good
bit larger.
This
is possible probably, especially when you have an old conventional X-ray system
that has been retrofit with a digital image receptor and the collimator is
manually adjusted. Again, you are
interested in this portion of the image, and following the work, somehow this
is all that is stored because you can electronically crop the image and save
storing all this unwanted information in your PAC system or use all that memory
that would be required, but you can't tell that the X-ray field was much larger
than necessary, even larger than the image receptor.
This
is not an issue that we have pursued a lot here at the Center up until now, but
I think it is one that we will need to look a little bit at. I just wanted to mention this as sort of one
of the things that I think has appeared on our plate as a result of some of
some of these comments.
This
would be an issue perhaps in computed radiography or digital radiography. It's I don't think really an issue in
fluoroscopy.
So,
there are questions here that we have about this electronic cropping. Do we need to address this issue somehow,
particularly for digital systems, and is it an issue only for systems that
store these images afterwards?
Suppose
the technologists, in their pre-review of the image, can do this cropping, and
not give the radiologists the full picture to begin with. That is one of the questions we have, so is
this something that is a concern to the community. I think we will have to be looking at this with value input from
the committee.
We
also had a few things that we didn't quite get right in the Notice of Proposed
Rulemaking. We had a discussion in
there of unique modes of operation.
This was something that should have been taken out because this had
bearing when we were proposing to require manufacturers to describe in the user
information both modes of operation and the doses associated with those modes,
and we were making the point that any dose that was more than 88 milligray per
minute was a unique mode and we wanted to get that dose information.
We,
in fact, decided not to propose that.
We are only proposing a dose display, so there was a little bit of
confusion in the preamble about this, so the point is that doesn't apply
anymore.
We
left off an effective date on our issue describing the addition of filtration
for half-hour X-ray tubes, the idea of having the ability to add additional
filtration above the minimum when that is required, say, for a large patient.
We
also need to clarify how there is an indication of what filtration is being
used. We didn't specifically lay that
out in the standard, and I think we realized that users need to know if
additional filtration has been added and how much it is or what it is that has
been added, so we are working on this requirement to refine it.
It
was pointed out that in our attempt to improve that half-value layer of the
X-ray beam, we proposed, of course, an amendment to increase the minimum
half-value layer. That has an impact on
the requirements for attenuation requirements on material that is between the
patient and the image receptor.
We
have a requirement that says if you are putting material between the patient
and the image receptor--this is things like a cradle to support an infant--you
don't want that to be very attenuating and require extra dose, and it turns out
that by changing the half-value layer of the minimum required filtration, we
effect this.
So,
the numbers here need to be adjusted slightly in the table that presents these
values in the standard, and we would be adjusting these to match the IEC
standard, which has already taken this into account.
There
is a question about the tolerance, a I mentioned, on the dose display, and, in
fact, we proposed two different ways of doing this in the preamble that we
shouldn't have. We proposed (a) that
the manufacturers state what the tolerance is, and then later, over in
1020.32(k), we told them it had to be plus or minus 25 percent. So, this requirement shouldn't have been
there, we didn't mean to propose that.
There
was also a typo in this section that just garbled a sentence having to do with
the alternate location that a manufacturer can specify for this reference
point, so if you reading this section and it's confusing, you are right. We will clear that up.
So,
those are the kind of comments we got, some of the things that we have got on
our plate to deal with. How long is it
going to take to finish this? We think
we will finalize regulatory wording decisions here in the very near future and
be drafting a Federal Register Notice.
We
didn't get a lot of comments on the cost/benefit or the impact assessment, so I
don't think we are going to have to do a lot there. We did get a couple of comments that said we had way
underestimated the benefit, that there was tremendous risk from X-rays and
therefore we were going to do a lot more good than we had estimated.
That
may be true, but I don't think it will hold us up from going forward with the
proposal. We will, of course, have to
have the usual review process in line to deal with what we have done and we are
hopeful that we can have the thing out of here by the end of the year I guess,
but as I have always said when I mention dates like this, don't hold me to it.
One
thing I wanted to mention just briefly is this issue of the IEC standards, and
you heard a little bit about this from Lillian Gill this morning, which was the
relationship between our performance standard and the IEC standards.
I
really said that I wanted to sort of put on the table and out in front of the
public some of the things that we are talking about internally to sort of put
this into context a little bit. I don't
think we have reached any decisions, but I did think it would be useful to hear
from the committee opinions of views on this issue.
Just
sort of to recap, there were no IEC standards early on when we developed our
standard. This was done in the late
'60s, early '70s. The process for
developing an IEC standard is a little bit different. Their standard is based on the consensus of national committees
voting.
They
are maintained by maintenance teams, working groups, who are members of these
national committees, are appointed with the blessing of the national
committees. The structure particularly
of the teams that are doing the X-ray standards currently are kind of being
revised a little bit, but there is active looking at the diagnostic X-ray
standards under the IEC process, sort of on a continuing basis.
The
IEC standards, there is a question about how enforced they are. Clearly, to get the EC mark for marketing in
Europe, you have to deal with a notified body who wants to know that you are
compliant with these standards. Often
that is done by type-testing of a model or factory visits.
We
are not clear, though, how detailed this is in all the various countries, and
one of the things that we have always prided ourselves on I guess to the FDA,
that if we are going to have a standard that is worth enforcing, we want to
make sure that people comply with it.
Another
issue is our FDA standards only address radiation safety performance, very
limited field of view, whereas, the IEC standards cover the gamut of both
radiation safety, all other kinds of safety, and even process, measurement,
methodology, a lot of different things, and sometimes they all get mixed into
one standard.
So,
adopting an IEC standard is a little complicated if we are trying to only pull
out of that the things that address radiation safety. So, one of the questions is could we use these somehow to lighten
our load of standards development, in particular perhaps for medical equipment,
where we have the other regulatory program for medical devices, we might see
some synergy that could be adopted here.
I
am not sure how far we can go with the other non-medical products, but those
are kind of the things that we are discussing here. We would like, I think, comments and views of people on this.
One
of the questions, of course, is if you adopt an IEC standard or use it, how do
you enforce it, what is the impact of doing this on the State Radiation Control
Programs. Most of the state programs
have regulations modeled after the U.S. Standard. They inspect for us, they check compliance just to the same
standard that we are using, not that that couldn't be done and developed for an
IEC standard, but there would be considerable work and perhaps disturbance in
getting there.
What
is the impact of adopting an IEC standard if it's not a formal regulation on
what is currently now there in terms of the federal pre-emption of state regs
when we have a federal reg in place?
So,
those are some of the issues that don't come to mind immediately, but they are
underlying this issue of how can we consider using IEC standards or would that
be appropriate.
Could
we use somehow the medical device authorities that we currently have in
combination with voluntary standards, to somehow at least assure medical
devices provide adequate level of safety?
Some
other questions one could ask, could we do this without legislative
change? It is not clear to me that we
could, but we are just at the beginning of these kinds of discussions, and I
don't think we could reach any conclusions currently.
Would
public health be adequately protected if we placed a lot of reliance on the IEC
standards? Could the FDA or the U.S.
National Committee play a more effective role in making sure that the IEC
standards do what we think are needed?
Often,
in the IEC process, if you are not there at the table, actively involved in it,
you don't have a whole lot of influence, and we have not been as active in some
of the X-ray standard work as we might have liked to have been in the past,
however, we did play an active role in the development of the IEC standard for
the X-ray Equipment Interventional Radiology Safety Standard. Bob Gagne [ph] on our staff was a member of
that working group.
Much
of what we are talking about doing in these amendments will get us in line with
what they did in the IEC standard, but there are a few national deviations that
we are thinking about.
Another
question one could pose is do the current problems with X-ray systems warrant
continued mandatory standards, are we in the mode of operation where this is
still the best way to spend our dollars, enforcing a mandatory standard and
dealing with that. I think valid
discussions could be had on both sides of that issue.
Would
we get a bigger public health impact if FDA were doing other things like
education or data collection or training activities rather than some
enforcement type activity?
So,
there are a lot of questions on our plate here as part of this, looking at what
our rad health future will be, but I think, in summary, we got a lot of
comments, they were generally supportive of our proposed amendment, so we have got a few final decisions to make
on some of the questions that I outlined, and we would welcome the committee's
comments or questions if you have any.
DR.
ROTHENBERG: Thank you, Tom.
Any
comments?
DR.
LIPOTI: I really like the alternative
display of dose information that you described where you would have both the
display of air kerma and the cumulative display. I don't know why didn't think of that before, but that really is
the way to go.
When
I do my exercise equipment, it gives me one or the other, and it is really
annoying.
DR.
SHOPE: Apparently, some of the
radiologists thought that way, that is where we got the suggestion.
DR.
LIPOTI: I met them in the exercise
room.
In
terms of the future role of the IEC standards, I see a difficult problem
because our authority is somewhat limited, and the IEC standard goes beyond
what we would have the authority to enforce.
So, it is also not clear to me, in a state program, we may need
legislative change before we could do that.
Of
course, states look to the FDA's leadership role in a lot of these kinds of
standards, so the way that you are going has a great deal of influence on what
we should be doing. That is a
significant sticking point. I also
wanted to emphasize where would we have the best public health impact.
It
may not be with enforcement of the standard, but it may be with the education,
the data collection, and making that available. I think the next studies are a real example of something which is
non-regulatory, but that has a great impact on public health.
DR.
ROTHENBERG: Yes.
CDR
LOSCOCCO: Were there any concerns about
when you--I also like the air kerma rate and the cumulative rate, but were
there any concerns about indicating what that was versus the skin dose
mapping? Obviously, it is going to be a
little misleading, that is the entrance dose, but you could have panned around
quite a bit.
DR.
SHOPE: Well, the proposal that we made
in the Federal Register was, of course, for dose display of air kerma rate and
then cumulative air kerma at the conclusion of irradiation. That was our proposal.
A
couple of comments came back that we like that, that is good, that is an
improvement, but what we would really like, a dose skin mapping requirement, why
don't you guys think about that. I
think my point here in bringing that up is we have had that suggestion, but it
is not something that we could impose without another notice and comment
process, and understanding, you know, is that feasible, can manufacturers do
that.
Well,
at least one of them has, but how much did it cost and why didn't they keep it,
you know. There are a lot of those
kinds of issues that are still out there, but we think it is probably a useful
feature, and we put some FDA money to look at that a little bit in terms of our
small business innovative research grant that we have made.
CDR
LOSCOCCO: And the new CT systems that
have CT fluoroscopy, is that also covered?
DR.
SHOPE: CT systems, they are not covered
by the fluoro.
DR.
ROTHENBERG: Tom, on the cumulative
display, there is still nothing here about storing that information, is that
correct?
DR.
SHOPE: That is correct. We didn't propose that. Surprisingly, we didn't get any comments
that can come to mind that it ought to be stored anywhere. Clearly, manufacturers in many cases would
store this information in their voluminous computer capability and would have
it there to know what has been happening with the X-ray system.
I
think if the vendors in the community are interested in providing that feature,
it wouldn't be difficult for a manufacturer, if they are displaying it, also to
save it and print it out or do whatever they want to do with it, put it in a
DICOM header if these images are stored, but that was not part of our proposal
and we really didn't get comments advocating that.
DR.
ROTHENBERG: I think certainly for both
this and the CT, it would be excellent to do that. Maybe that has to come in the next round, but I would like to see
at least the committee recommend that you look into that, even though it is not
part of this already issued.
DR.
SHOPE: There is always a possibility of
a slight question, well, I can make the immediate connection that display to
the user, which allows them to change a procedure and save dose as radiation
safety protection. The recording, the
requirement to record that, is that also radiation protection? I think we would have to develop a good
argument for why that is a radiation safety feature as opposed to a convenience
or a recordkeeping or helping do quality assurance feature.
But
we could probably make that argument, but I am just saying I am not sure I know
how to make that argument right now.
DR.
ROTHENBERG: Certainly, if somebody
comes down with these big skin burns sometime later, it would be nice to know
for sure that was the reason.
I
would also like to comment just on the 25 percent versus the 50 percent. I think 25 percent is doable if this is
going to be applied in conjunction with other studies done at other times. I think we would want the smaller, more
accurate measurement.
DR.
BENSON: I definitely agree with
that. Something that varies by 50
percent is not really useful in terms of recordkeeping because you wouldn't be
able to compare from time to time. You
would have no idea what was going on.
DR.
SHOPE: I think most of the times I
wouldn't expect that a system between the first measurement and the second
measurement on the same system you would see that kind of variability. It is just it would be somewhere in that
range constantly and not jumping all around would be my expectation.
So,
you would, I think on a particular system know that the display is pretty well
constant and you are getting a constant relative kind of number, but system to
system, or facility to facility, it raises a lot of issues.
I
think the other thing you have to keep in mind in thinking about this
requirement is what does it take to present this number. This is not something that the meter tells
you, but it is going to have to be a number that is inferred either from
calibration of the technique factors in the X-ray machine and some computation
about where is the source in the patient, so there are a number of factors, and
you start combining those errors, I think that is the reason at least for the
IEC standard, that those numbers got to be probably bigger than 30 percent, and
they used a limit of 50.
But
there may be some ways to look at that and tighten that up, but there are a lot
of factors that could go in. If you
have a direct monitoring system that actually has a meter in the beam, and is
somehow measuring this, and then using that to infer the dose at the reference
point, there may not be as many factors, so we will have to look at how that
can be played out.
DR.
BENSON: Yes, that was the other part of
my question. The air kerma rate, how is
that modified, by collimator distance shielding?
DR.
SHOPE: Well, I mean the rate if 1 over
R-squared in distance from the source.
Collimator really, the number we are talking about is the free in air,
so it's independent of scatters, so if you have at the patient's skin, a
certain amount of radiation, and you enlarge the field, you will get
backscatter from the patient, that will probably make that number on the skin
go up, but the air kerma rate, which is free of backscatter, would not change
as a function of collimation. This is
meant to be the dose to the skin, not how much skin is getting the dose.
DR.
BENSON: Okay.
DR.
ROTHENBERG: One thing with regard to
that accuracy, we have systems that just do dose area product, not based on a
measurement, and they are very close. I
mean they are really accurate, surprisingly accurate.
So,
I think if they can do that in conjunction with collimation information--
DR.
SHOPE: There is an IEC standard for
dose area product meters, and it has a 50 percent spec in it.
DR.
ROTHENBERG: But I mean the actual units
where we measure, they are much better than that, they are not even close to
having a 50 percent or even 25 percent.
DR.
SHOPE: That is the kind of experience I
think we need to have to support this kind of requirement.
DR.
CARDARELLI: I wanted to concur on the
plus or minus 25 percent. I think
technologically-wise, we can do a lot better, so I would definitely concur with
that.
The
other thing is without a question of a doubt, we could develop a strong enough
public health argument to record the cumulative dose. I don't think that that is going to be very difficult. In addition to recording the dose, I would
also go so far as to address the cropping issue of the digital image.
We
could simply record, if it's possible, the field dimension of the X-ray, as
well as the cropping image dimensions, and those two pieces of information will
be able to capture that field size without increasing memory.
DR.
SHOPE: I raised that issue just to
point out that we got some comments on some things that we really hadn't been
considering and would probably take a little work to work out, so if we go
forward on that, you will be hearing from us again I guess in the future on
that kind of an amendment.
DR.
PLATNER: I wanted to step ahead a
little bit off the accuracy, which I agree we need more accurate measurement,
but one of your other points was that you suggested that ultimate responsibility
for modifications should be able to be shifted to contractors that might design
the modification or make the modification.
I
guess I would oppose that sort of change.
I think that the owner or user has to at least share responsibility,
because I know in construction, that is the normal practice. You shift all the responsibility of
contractors and subcontractors and sub-subcontractors until the guy that is
responsible in court is incapable of doing the work.
I
would hate to see that happen here.
DR.
SHOPE: I think our approach would be
that FDA says the user, the owner is responsible for this. My comment was in response to the user
saying, hey, we are not technically competent to know if it's in compliance or
not, and our answer is, well, then don't make the modification unless you are
sure that the person who is doing it for you had that competence and you have
worked out some kind of arrangement, so that you hold him responsible if you
don't want to be responsible, but ultimately, FDA is going to look at the owner
as the responsible person.
Now,
whether that gets to the liability issue is a different story.
DR.
ROTHENBERG: Any other comments?
DR.
SHOPE: It was a status report, as I
said, we are not going to tell you what we are about to do because we are
constrained from doing that.
DR.
LIPOTI: Larry, did you want us to
memorialize some sort of motion that we support the recording of dose?
DR.
ROTHENBERG: Okay. Do you want to make that proposal?
DR.
LIPOTI: Yes. I propose that.
CDR
LOSCOCCO: Can I make one more comment
before you do that?
DR.
ROTHENBERG: Sure.
CDR
LOSCOCCO: I would think some people
might have a problem if you are only recording the maximum dose. We have the
program that Dr. Shope was talking about, and your dose, your peak dose can be
as much as 60 to 70 percent different than the dose--
DR.
ROTHENBERG: Yes, because of the angles.
CDR
LOSCOCCO: So, recording of what?
DR.
ROTHENBERG: Well, as long as it is
understood. I mean for the moment, that
is what the meter is going to give you.
I think it is better than not recording anything with the understanding
that it could vary, and you might know from the type of procedure that was done
that yes, this is going to be pretty close, or, no, this is because the beam is
going to move around a lot, this could be low by a factor of 2 or 3, but you
still have the number, and then you could have something to work with, I would
think.
All
those who would be in favor of recommending that this number be recorded?
Opposed? One.
Abstain? Two.
It
was two, one, and everybody else. You
might want to record just the numbers themselves.
MR.
KACZMAREK: This is not going to appear
in the final rule. This will be a
future consideration.
DR.
ROTHENBERG: Right. Given the discussion, I think you would want
to look into is this the best thing to record, but at least we would like
something recorded, if this is there, and that is all that is there, yes, if it
can be more specific to the procedure.
MR.
MYRICK: In conjunction with any
requirement you might come up with to record this information, you would have
to establish some type of retention policy.
How long are you going to keep that?
DR.
ROTHENBERG: I would think if it's
something that could be added to the digital image data file, then, it would
just stay with that image forever as long as the image were there, and there
are certain legal requirements on the images.
DR.
SHOPE: I think FDA might want to just
say the equipment must provide the mechanism for recording without getting into
the medical practice of how long that is part of the patient's medical
record. We could require the equipment,
give this capability. We couldn't direct
the user what to do with it, I don't think, in terms of an equipment
performance standard.
DR.
CYR: But there are other requirements
on how long the images have to be stored.
MR.
KACZMAREK: My hope would be that once
this rule publishes that we are working on now, that the manufacturers would go
ahead on their own and record the cumulative dose, make it part of the patient
file just because it might be a nice thing to do.
DR.
CARDARELLI: I guess I would disagree
with that. If you make it voluntary on
any manufacturer, they will not do it largely for legal purposes probably. For public health purposes, it is critical
even though the dose itself may not be the true dose the body absorbs.
If
one had to reconstruct, say, with the dose to the bone marrow or some organs or
whatnot, we would then have a starting point to go from. Right now we have nothing to start from
except perhaps a guess what the machine settings were, and then we would have
to reconstruct.
At
least we have a measurement now, and that is why I would be a strong advocate
for recording some level of cumulative exposure or dose with the image, and not
necessarily making it voluntary for the manufacturers.
MR.
KACZMAREK: What I was saying was that
in the interim, in near term, until we got around to making it a requirement.
DR.
ROTHENBERG: You can't add it to this.
DR.
CARDARELLI: I understand.
DR.
ROTHENBERG: Thanks a lot, Tom.
DR.
SHOPE: Thank you.
DR.
ROTHENBERG: Now we are ready for a
presentation by Frank Cerra and Dan Kassiday of the Security Screening Systems.
Security Screening Systems
MR.
KASSIDAY: Hi. I am Dan Kassiday. I am
with the Office of Compliance. Again,
here we are talking about ionizing radiation security systems. Hopefully, this year we will see a few
different things.
The
goals for today are to update you all on emerging issues and new products
especially since 9/11, familiarize the new committee members with the other,
somewhat in the past, controversial items that we have dealt with, and discuss
progress on the previous recommendations and new projects that are ongoing, and
hopefully, hear committee discussion to support and guide these efforts.
Just
a quick overview of what I will be talking about. The good old cabinet X-ray systems have come into some contention
with airport workers recently. Vehicle
and cargo scanners are being bought and installed in many, many ports around
the nation, and could present a significant risk if misused.
There
are some new products that people are talking about, a couple of things that
are getting near to release, and, of course, Personnel Security Screening
Systems. Then, I will talk about what
FDA has been doing with these things and leave you with a few relevant web
links. Then, Frank will go over some of
the studies and reports on personnel scanners that have come out in the last
year, as well as go over a history of what we have done with those products.
These
are cabinet X-ray systems. You probably
recognize the one on the left as something you have put your carry-on luggage
through. The one on the right is
probably used for some sort of quality control on soft foods.
They
appear everywhere. The industrial ones
are still pretty quiet. The ones at the
airports aren't any more dangerous, but there is a perception of risk with
them.
These
two are explosive detection systems.
They are also considered cabinet X-ray systems. You will note that they are rather
large. The one on the left is a spiral
CT system. The one on the right I
believe is a straight slices [ph]. They
are intended for checked baggage, and tend to be the center of the controversy
in most airports, as I understand it.
Airport
X-ray systems went under TSA jurisdiction when the screeners went under TSJ
jurisdiction, which caused some issues with states formally regulating these,
and now they are not regulating these, and generally, people being concerned
about who is regulating these for the use.
We
have been assisting TSA in developing their own internal policy for how these
systems should be used. There have been
a number of worker complaints and concerns especially near the EDS systems. Apparently, Customs workers that work near
those EDS systems have little geiger, you know, crystal pagers for radiation
detection, and they are very sensitive, and occasionally, you will get some
scatter and they will go off.
We
have done surveys in response to that and found nothing unusual in compliance
systems, to the best of our knowledge.
TSA
has contracted for NIOSH to do a study on basically worker exposure, and Dr.
Cardarelli is primary investigator on that.
We
also periodically get questions about what happens if I run my food, drug,
computer through these systems, and we put out a Frequently Asked Questions
document that addresses this, and our response is pretty much the same - as far
as we know, there should be no effect.
The dose range for one of those carry-on screening systems is 1 millirem
or probably much less to any object that goes through.
The
EDS systems only in worst case can get up to 120 mrem. None of these are excessive dose. That is to products going through them. Of course, film can be an exception, and the
EDS systems are the ones most likely to affect film.
Again,
in our Frequently Asked Questions document we publish, we point people to the
manufacturer web site for the film, you know, how should I take care of my film
when I am flying, that sort of thing.
These
are the emerging issues. We have got
cargo and vehicle systems. They are
large systems, they, in general, will either move past the system they are
screening, like the truck on the right, or a truck or a part of the container
is pulled through it, like the system on the left.
Down
below we have what looks like a backscatter image for a vehicle. Some of these systems do both a backscatter
and a transmission image to give various contrast for the people looking at the
images. Backscatter just means it's
resolving the image from bouncing the X-rays off the system or a product being
scanned, and transmission, of course, is image receptor on the opposite side,
much like a normal medical X-ray.
This
is an example of a truck that was crossing the border down in Mexico, and you
will see that there are some inadvertent exposures periodically along with the
bananas.
This
is a relatively new system. It is
basically ISO containers like you would put in cargo ships, and they can be
relocated in a matter of a few days to put where they are needed. You see a tractor on the right side pulling
a truck through.
This
is a concept for an accelerator-based system. Again, it is going to have a
tractor system to pull the vehicles through it. It appears that it is here, a picture here in a port. We can imagine that it might be on borders
or on bridge crossings, et cetera, as well.
All
these systems at present are intended to X-ray these vehicles without any
passengers, without any drivers.
This
is a backscatter-only system. What it
is, is a panel truck, and they have got a similar, but lower powered X-ray
system in there, and they can use that for doing cargo containers, as well as
perhaps personnel or security along parade routes.
As
far as I know, they have not distributed that in the U.S. yet. It is clearly not a cabinet X-ray system and
it really doesn't fall under any of our standards.
As
I understand it, the company is designing it to meet the personnel screening
standard for that mode, but, of course, in this case, it depends on whether the
people or the vehicle are moving at an adequate speed to test what the dose
will be.
A
couple more examples. This one drags
the system around, then, drags the vehicles through it. Another fixed site I believe in Hong Kong,
and that is a transmission image as opposed to a backscatter image.
The
one on the left is a isotope-based system probably cesium or cobalt 60. The one on the right is the first accelerator
mobile system that has gone to the shipyards.
As I understand it, more of those are being built and are fairly
successful.
Of
course, the one on the left is mainly an NRC issue, however, when we get to, in
our participation in an ANSI Committee that we are trying to start to consider
these products, we are going to go ahead and consider isotope systems, as well
as X-ray.
Anyway,
things that are coming along. We have
got the backscatter X-ray van, which has a relatively low output as long as it
is moving along. Many manufacturers
have discussed portals, which you can drive through, which would be intended to
not only screen your car, but you, or trucks, or et cetera, maybe parking
garages.
There
have been any number of places these things have been considered - Andrews Air
Force Base, like when the President is going to fly out of Air Force One, et
cetera, and, of course, various things to do, people and pedestrians.
There
could be some high energy accelerators used for certain cargo containers. The current ones only extend to 6, maybe one
was 8 megaelectron volts. Right now the
high energy ones aren't out there, but there are some uses for them, as I
understand it.
Machine-produced
neutron systems, there is one in development that has been funded by Congress,
and other unpredicted technology which we are going to do our best to try and
stay on top of.
Here
is the concept for the Pulsed Fast Neutron. It is similar to the X-ray systems,
they pull the vehicle through. Several
reports have been done by the National Council of Radiation Protection on
measurements as part of the Environmental Impact Statement for this product, as
well as things going through it, activation of possible cargo and all that sort
of thing.
According
to the NTRP and the manufacturer, there shouldn't be a real problem with the
items coming out of it, although I understand they are also building a concrete
bunker to put it in to shield the neutrons adequately.
The
one on the right is off the same company's web site. It is apparently a mine detection system. They are shooting neutrons into the
ground. I don't know of that being sold
in the U.S. yet, but who knows what is out there.
As
a follow-on to our Personnel Security Screening System's success in getting a
standard out in two and a half years, we are working with Customs, NIOSH, OSHA,
and some other agencies, TSA, to try and begin the development of a consensus
standard that will adequately address these systems that are now being rapidly
deployed, that the cabinet X-ray system is not necessarily appropriate for, and
that cause considerable worker anxiety among the dock workers, et cetera, and
in this case, when they are accelerated, possibly for good reason, if they are
misused, and try and predict what could be coming up and control exposures from
things, so that we don't get so safe that we hurt ourselves.
This
is the typical question we get asked about the personnel systems, "Is
their use justified?" Only if the
risk results in a societal benefit from the increased security.
This
was the first backscatter X-ray system.
As you see, it looks through your clothes, detects the plastic, the gun,
et cetera. This was the second. Those are the only two that have been
reported for sale in the U.S. at this time.
Additionally,
this system has now been reported. It is an transmission X-ray system. To the best of my knowledge, none have been
sold yet. You can see that it looks
through you for contraband concealed within you. We are still discussing things with the manufacturer's
representative, and as a result of basically this system coming along, we have
decided that we need to take our consensus standard and convert it to a
mandatory performance standard, as we discussed last year.
So,
what are we doing? We published
basically a Consumer-Operator Frequently Asked Questions document about cabinet
X-ray on the web. We have participated
in the development of a consensus standard for radiation standards for the
cargo and vehicle systems. We had a
pre-meeting in August. We are hoping to
resume in I believe November with the N43, which is the Health Physics
Society's Radiation Safety Committee before ANSI blessing.
We
have drafted internal guidance, which is moving its way through review about
who to contact about what systems, so at least when a law enforcement agency
comes to us, we can get them to the right people quickly.
There
is a draft guidance for manufacturers.
There is going to be one for users, as well, eventually. We have begun drafting a proposed mandatory
standard for the Personnel Security Screening Systems, and we have hired NCRP
to do a report about personnel security screening systems, that is now
available on the web, and Frank will be discussing that in detail.
So,
what did we cover? In the cabinet X-ray
consumer document, let's call it, what these things are called, security
screening, cabinet X-ray. They come to
the FDA site for more information about what kind of dose am I getting, it's
awfully hard to find it unless there are other terms for them to search on.
Who
regulates them? Is it safe to be near
them? Personnel monitoring, is it necessary?
Food and other products being safe after they travel through these.
On
the question of personnel monitoring, as far as we understand OSHA's
regulations, if the cabinet X-ray system is the only radiation source in an
area, it is not a restricted area, and therefore, there is no personnel
monitoring required at the federal level.
Of course, some states have different regulations.
For
the cargo systems, don't have appropriate standards, we are beginning work on
that. ANSI N43.3 was last updated in
1993 and covers general radiation safety for basically anything that is not a
closed system, like a cabinet.
We
didn't feel that that really adequately addressed the safety needs of large
moving accelerators, and also the fact
that there a lot of them becoming widely distributed.
The
internal directory, as I said, is drafted and in management review. Manufacturer guidance which covers product
evaluation, you know, how we evaluate each one independently because they all
seem to be very different, the basis for our regulatory decisions, basically
supports the use of the N43.17 Radiation Safety for Personnel Security
Screening Systems, that we published last year.
History
of the regulation of these products, applicable FDA regs because there are some
reporting and recordkeeping requirements, and an announcement that we are in
the process of drafting a proposed mandatory standard.
That
has been drafted and is incorporating various comments from within the Agency,
hopefully, will be moving along for management review in the next week or so,
which translates into maybe in a few months it will see the light of day.
We
will be drafting a guidance for the users.
We will essentially take the concerns raised in N43 standards as a basis
for this, how users should record-keep to assure they don't go over individual
limits, user training that is appropriate, those sorts of things.
That
will be coming after we get a draft of a new performance standard, and we will
be taking the highlights of the performance aspects again of N43.17, such as
the effective dose limit of 10 microsievert for a front dose, labeling
requirements, leakage, test methods, those sorts of things.
FDA
and TSA contracted NCRP to evaluate the radiation risk for these sort of
systems just to confirm that we are going in the right direction. That report again has been completed. Frank
will be talking about the details shortly.
This
is where you can find all these good things.
It
is probably easier to let Frank go ahead and talk and then ask questions at the
end.
MR.
CERRA: Thank you. I am Frank Cerra. I will be presenting yet another update on the Personnel Security
Screening Systems, actually, just a continuation of Dan's talk.
Before
I do that, let me give you some of the history for the benefit of those new
members of the committee and also as a review.
The
Personnel Screening Systems were discussed in the September of '98 meeting of
TEPRSSC. At that meeting, the
discussion revolved mostly around the backscatter systems because those were
the ones that were being used in this country.
At
the end of the discussion, it was recommended that a mandatory standard be
drafted by FDA.
FDA,
instead of the mandatory standard, felt that we could go ahead with a consensus
standard, get that in the books sooner, and at the same time, get a lot of
input from the industry and get them to buy into it and maybe that would
suffice.
So,
we led that effort and in April of 2002, we actually had the standard, the
Radiation Safety for Personnel Screening Systems Using X-rays. In June of last year, we discussed
transmission systems which began to show up in this country, not being sold,
but just knocking at the door basically.
Again, the need for a mandatory standard was reaffirmed.
The
recommendations of this committee were that the mandatory standard should be
based on the requirements of ANSI N43.17, but the committee also recognized
that there may be a limited number of uses where it would be desirable to have
a transmission system, for example, where you could use them in lieu of doing a
medical X-ray exam when a suspect had been suspected of swallowing
contraband. In that case, it would
actually save dose to the subject.
So,
it was proposed that the mandatory standard also allow for exceptions to
provide for those uses, and it would provide for the appropriate manufacturer's
instructions on how the equipment or how and when the equipment should be used.
That
is where we felt, "we," FDA, we needed some help from other
organizations and institutions because this is really a societal question on
how to use or when is the use justified when it is non-medical.
To
review the limits, I think Dan has already shown these, the ANSI standard. It is 0.1 microsievert per scan, that's 10
micrograms, and 250 microsievert of effective dose per year to any one
individual.
Since
last year, there have been two new documents from two of the leading
organizations in radiation safety. In February of this year, the Health Physics
Society published a position statement on these products, and also, as Dan
mentioned, we have contracted with NCRP to provide us with guidance, and
presidential report format was chosen for this effort because again it was felt
that it would be completed sooner although there is a strong review process for
presidential reports, it is not as rigorous as the regular NCRP report.
Now,
there has been a lot of confusion about this, I want to reassure you right
now. This does not come from the White
House. Presidential Report refers to
the President of NCRP.
The
principal requirements or recommendations, I should say, of the Physics Society
statement are given here in their entirety.
The practice should be limited to those applications that result in an
overall net benefit to society. When
the practice is used to screen members of the general public, screening systems
and their use should conform to the requirements of ANSI/HPS Standard N43.17,
and the subjects should be informed of the radiation exposure.
Now,
this is a good endorsement of the voluntary standard, and it also leaves the
door open somewhat for the transmission systems, which is consistent with the
recommendation from this committee.
In
addition to that, the position statement also has this sentence. "Appropriate organizations should
develop criteria for determining when the societal benefits of public screening
outweigh the risks associated with ionizing radiation exposure." The criteria should be basically a consensus
of all the interested parties.
Again,
this is where we also felt we needed some guidance. So, in keeping with that statement, FDA with co-sponsorship from
the Transportation Security Administration requested guidance from the National
Council on Radiation Protection and Measurements.
Although
the Presidential Report has now been published, it is also being published as a
Commentary No. 16.
The
FDA's request to NCRP included these points. We asked for a review of risk
assessment for this type of radiation exposure. Again, we asked for guidance on what constitutes appropriate use
conditions, any considerations that should be given to targeted and susceptible
populations, and what the dose limits should be, and should there be informed
consent.
We
also asked for guidance on how to determine when an operator is deemed
qualified to run these systems, guidance on how to determine a net benefit,
again, you know, how do you weigh what is the benefit versus the risk, and
guidance on what kinds of records should be kept by the user facilities, and
should we discriminate between general screening and follow-up evaluations or a
more limited type of screening situations.
The
task of writing the report was given to the Scientific Committee 1-12, which
was formed for that purpose, and, hence, the report's designation SC 1-12.
The
committee responded to those requests in the following manner. The scope of the document is compatible with
present NCRP system of radiation protection.
The committee was not going to rewrite the books and reinvent the wheel,
so anything that came out would have to be compatible.
The
report does include a brief review of risks. It considers potentially screened
populations and susceptible subgroups, such as infants and pregnant women.
It
does make recommendations for dose limits based on radiation safety and
usefulness of the images.
The
report addresses the need for communication of the radiation exposure and its
effects, operator training requirements, recordkeeping, and testing of the
equipment including surveys.
What
it does not address is how to determine a net benefit. The committee felt that this is a societal
question and it is outside of the scope of NCRP.
So,
one of our main concerns was not addressed, however, the report does provide
some real guidance that will be very useful and something that we can use. It is being repetitive, useful, and
something that we can use.
I
will jump to the bottom line. The gist
of the report is that the radiation dose from the systems must conform with the
recommendations in NCRP Report 116 for frequent exposures for the general
public, and that is from all man-made non-medical sources, the dose should not
exceed 1 millisievert per year. That is
100 millirem per year.
So,
everything in the report is basically in support of this.
We
also realized that that would be an impossible task to determine where an
individual has been for the past 11 months or 12 months, so that they would not
be given a dose in excess of the annual limit.
So, therefore, we felt that the administrative control of a quarter of
that 0.25 millisieverts would be a better alternative to impose on a facility,
and that is an alternative that is also in NCRP 116.
Also,
the committee felt that the administrative control would adequately protect all
members of the population including the most susceptible ones.
The
report divided the screening systems into two categories. The General-Use Systems, basically those are
the ones that conform with the ANSI Standard, 0.1 microsieverts per scan. That is effective dose again. Basically, it
includes all the backscatter systems.
For these systems, it would take 2,500 scans in a year to reach the 0.25
microsieverts administrative control, so there really isn't a whole lot of need
for recordkeeping.
The
other category would be everything above that, but we also have an upper limit
of 10 microsieverts per scan, and that would include the transmission systems.
Again,
the General-Use Systems would be acceptable for screening general public. That is consistent with the Health Physics
Society statement also. But the
Limited-Use Systems should be used with discretion, only when following up on
someone who has already been suspected from another screening method of
carrying contraband or weapons.
Before
using the Limited-Use Systems, the report recommends that other non-ionizing
alternatives be considered. Again, the
administrative control of 0.25 millisieverts in a year from one site should not
be exceeded.
To
stress that point, users of Limited-Use Systems must assume responsibility of
providing reasonable assurance that the annual administrative control is not
exceeded. This can be done through
written protocols and rigorous recordkeeping.
The
committee recognized that this is still difficult to do, especially when you
are screening travelers through an airport, who you have never seen before, but
I felt that if any user agency didn't feel that they could adequately provide
this assurance, then, they shouldn't be using these systems at all.
To
summarize the rest of the recommendations in the report, the dose to bystanders
was considered, and it was felt that they should be subject to the same level
of protection as an individual being screened, which is the level for the
general public.
Again,
rather than using the 1 millisievert per year, we are using the 0.25 from one
site.
Operators,
it was felt that it is certainly doable that they be protected at the same
level, and so they should be.
There
are some standard requirements for equipment testing initially and after any
maintenance or repair, which is consistent with all the other standards.
We
addressed operator training and we referred to other NCRP reports which deal
with training in detail. There is a
list of 25 topics to be covered by the training as a minimum requirement, and
also a requirement that annual refresher courses be given followed by testing
to ensure continued proficiency.
The
report recommends that information be given to the people being screened on the
risk, benefit, and comparative examples from the exposure they are going
through. The information should be
provided in terms that are easy to understand prior to the screening, and the
information should also be disseminated and be readily available.
The
examples of leaflets or posters at airports was suggested as a way to educate
potential subjects before they actually arrive at a site and where they don't
really have enough time to digest all the information.
It
was felt that informed consent was not necessary for these types of doses.
To
recapitulate, you have seen the slide at the beginning. TEPRSSC had recommended a mandatory standard
based on ANSI N43.17, which would also allow for some exceptions.
In
conclusion, we now have two of the leading institutions in this country on
radiation safety who went on record on this issue and basically reinforced the
TEPRSSC recommendation and also the ANSI standard.
I
don't have any questions for the committee.
As I said, this was only an update.
I think you made it very clear what you wanted from us, and, in fact,
some of you may be asking where is the mandatory standard.
I
thank you for your attention.
DR.
ROTHENBERG: Thank you very much.
Do
we have questions for either of our two speakers? Yes.
Committee Discussion
DR.
CARDARELLI: Just a quick comment and a
question, the question first. As far as
I know, there are no other international standards out there, so what we are
doing is leading the world with regard to this technology.
The
comment that I would like to make is that that's good that we are doing this,
but again, this is not a consensus that we might have to deal with, with the
IEC or other countries.
Another
question would be since we have done this for personal screening, and there is
nothing out there for the large cargo screening technology, which uses
completely different energies, isotopes, is it something that you want this
committee to recommend in a similar fashion that was done two years ago to get
some standard for that?
MR.
CERRA: Dan has talked about some
efforts that are going on in that area, and certainly you are welcome to
comment on whether we are going in the right direction, or whether there is
something that we are missing on that.
CDR
LOSCOCCO: I just have a quick question
on how a facility will determine that the individual can't get more than the
0.25 millisieverts in a year.
MR.
CERRA: Well, that is a very good
question. In some cases, they can't do
it, and, hence, they shouldn't use it.
In other cases, they may be screening a familiar group of people, for
example, prisoners or employees in a certain building who come in repeatedly.
They
could have a system which could be automated where someone isn't exposed every
single time. They may know it or not
know it whether they are being exposed or not.
This is a system that is being used in the diamond mines in South
Africa. So, that is one way. If they can show that any one individual is
not going to be exposed more than 25 times, if the system is at the limit,
then, they have complied with that requirement.
Now,
when you are dealing with passengers, that becomes more difficult. One way that you could show it is if the
number of inspections was so low in a year that it would be unthinkable that
someone would be exposed that many times, or if the risk was really high, in
which case it would be justifiable to be close to the limit.
For
the risk to be high, like I said, someone would have to have been suspected
through other means of screening.
DR.
ROTHENBERG: Dr. Benson.
DR.
BENSON: Would you clarify for me,
please, in the limited use systems, are they also backscatter systems, but just
employing a higher energy beam?
MR.
CERRA: No. The limited use systems are defined only as being systems that
deliver more than 0.1 microsieverts per scan.
At this point, that only includes transmission systems. All the backscatter systems can do much
better than that.
DR.
BENSON: For the backscatter systems on
page 9 of our Presidential Report, it says, "An effective dose of 0.1
microsieverts per scan would allow 2,500 scans of an individual," and they
say that that is an average of 10 scans a day, a frequency that is unlikely to
be encountered, however, on page 16, it describes backscatter systems as saying
that each person is scanned twice for an examination, and sometimes up to four
times if they do lateral scans.
MR.
CERRA: Right.
DR.
BENSON: So, that cuts into the number
of times that you can examine a person.
MR.
CERRA: That's true. Let me clarify. The 10 microsievert is the upper limit, and it refers to
effective dose. The ANSI standard has
some charts on how to calculate the effective dose based on an exposure
measurement.
The
backscatter systems that are being used are delivering about half of that or
less, maybe 0.03 to 0.05 microsieverts.
One
thing I didn't mention is that the limit refers to a frontal scan, you are
being exposed from the front. When you
are exposed from the back from the same machine, depending on the energy, the effective
dose is going to be lower because most of the vital organs, which are
susceptible to radiation, are in the front of the body, and from the sides,
even lower.
So,
even if you have a system that is close to the limit, it doesn't really double
the dose. You may get maybe one and a
half times the dose. So, it is true, it
may not be 2,500 scans, maybe 2,000 scans before you reach the limit.
DR.
ROTHENBERG: Kim.
MS.
KANTNER: I was looking through and it
wasn't apparent to me about any like quality assurance in terms of verification
of the operating status of the system.
Where is that going to be clarified or can you elaborate more on that?
MR.
KASSIDAY: Right now there isn't a
mandatory standard for what the machines have to do, so there is not a lot we
can evaluate their quality control based on.
Even if we found a machine that was a little bit out of sync, there is
maybe not a lot we could do because it would be hard to show a health risk.
The
point of the mandatory standard is once that's in place, they then have to
report to us how they are certifying that they meet our standard, and in doing
that, we will be looking at their quality control and testing systems, and that
will allow us to go out and start doing field tests hopefully with new
instruments with some luck to actually have some oversight over these.
At
present, the personnel scanners aren't really exploding into use per se. It is more the cargo systems and the other
large systems that actually have fairly high energy which are of greater
concern, which is what we are trying to concentrate on right now.
Does
that answer the question?
MS.
KANTNER: Yes, I guess I was getting
confused on the back here about the status of the mandatory standard. So, that
is under development still?
MR.
KASSIDAY: Very much so.
MS.
KANTNER: Thank you.
DR.
ROTHENBERG: Yes, David.
DR.
LAMBETH: It seems to me that to set the
standard based upon the long-term exposure may be missing the point in that we
don't really understand some of those things, at least I don't, and the rest of
the committee can correct me, but if the standards are set, so that you got the
entire full year exposure in one day, which is the way it is written now, it is
quite viable for that to happen by accident or by whatever, no one would want
that to happen.
If
I were setting a time period of integration, I think I would do it more on the
time scale of the body renewing, the cells renewing, and whatnot. So, on that basis, you would think you would
have an upper limit on a per day or a per few days or a week sort of time scale
rather than only per exposure and then per year.
Is
there any way to address that, or should it be addressed? I will ask my learned colleagues, as well.
MR.
CERRA: It seems to me that if you had
one limit per day, it would be very similar to the per scan, because in most
cases, you are not being screened more than once in one day.
Also,
like I said, we didn't want to invent anything new. We only went with existing recommendations from NCRP. Your point about reaching the limit in one
exposure, that was discussed, and that's why we now have an upper limit for the
transmission systems, which would required 25 exposures to reach the limit, not
just one.
So,
if you did one or two where you didn't keep any records, you are still off by
over 20.
Does
that help at all?
DR.
PLATNER: If you look at some subgroups
where people are working behind security barriers, like flight attendants,
machinists in an airport, construction workers working on nuclear plants or
defense contractor sites, I mean they may easily go through security a half
dozen times, maybe even more per day, and so just because they are going in and
out as part of their job, so it seems like there is a concern that they could
get close to that 25 especially if they are doing multiple scans.
MR.
CERRA: Again, if they were going in and
out several times in one day, then, those would have to be the general use
systems where the limit is much lower.
DR.
LIPOTI: I was interested in the Health
Physics Society position statement where they say that, "Appropriate
organizations should develop criteria for determining when the societal
benefits for public screening outweigh the risks associated with ionizing
radiation exposure," and they go on to say that, "The criteria should
represent the consensus of professional, consumer advocacy, labor, and business
organizations, academic institutions, government agencies, and the general
public."
I
think that should be done. My question
is, what is the appropriate organization for pulling all these people together
to determine the societal benefit?
Apparently, it is not the NCRP, because they say that is outside their
role as defined by the congressional charter.
Is
it the FDA?
MR.
KASSIDAY: In our opinion, it is the
people that would be using these systems to detect threats since they are the
ones qualified to evaluate what the threat is, and since the threats are
sometimes classified, we don't want to know what the threat is, we are happier
that they do and that they are doing what they--but we are trying to work with
those agencies to make them aware of what the risk is, so that when they make
their decision to use the system or not use the system, they are making an
informed decision and doing it for a rational reason.
DR.
LIPOTI: But are they involving this
consensus of all these organizations? I
would say they are probably not. They
are just buying the thing and installing it.
MR.
KASSIDAY: Well, fortunately, they are
not buying them or installing them at the moment. I mean the only agency I know of using personnel scanners is
Customs. They are using a general use system screening people coming into the
country who have already been selected for a patdown search, which means they
are not using it even generally screening.
So,
at the present, while I would love to have that dialogue occur, so I would find
out where we really should be, that may not be necessary since these things
just aren't proliferating yet. We are
trying to be proactive in establishing a mandatory standard before that happens
and to get some guidance out there and lay out things like the NCRP report,
which tells people this is what you are doing when you do this. Do you really want to do this?
For
example, if you go from a backscatter image to a transmission image, which
could be a factor of 50 or 100, are you getting 50 or 100 times more
information that is of necessary use?
That is sort of balancing, but we can't, again, we don't know what the
threat is.
DR.
LIPOTI: I guess I have a follow-up and
that has to do with the backscatter X-ray van that you showed us, that you said
could possibly be used to scan people who are lined up for a parade. I guess I am not clear on how you might use
this, you are driving past people and backscattering them?
MR.
KASSIDAY: The way it was described to
us, one, they can use it in a shipyard doing multiple layers of cargo
containers, and that is fine, they are shooting into a cargo container.
DR.
LIPOTI: But if it's a backscatter unit,
you are only getting the surface.
MR.
KASSIDAY: Well, as you saw in the car
image that was earlier, you can really see pretty deep with backscatter. I would assume they would have to do both
sides.
As
far as the parade route comment, the way it was described to me is they would
go, say, before a presidential parade or a VIP and screen the cars along that
route to look for car bombs and whatnot.
The personnel thing only has come up with reference to applications at
present overseas, as I understand it, where the van would be stationary and
probably covert, to determine if anyone is walking around with a bomb on them.
DR.
LIPOTI: Well, that certainly defeats
any informed consent.
MR.
KASSIDAY: Yes, it does. We are working with them to make sure that
whatever method they have of assuring that no one stands in the beam works
because that is the primary thing, that if the van is stationary, people better
be moving. Most of the other moving
systems have interlocks where if they stop or go slow or something, it cuts off
the beam, which is sensible.
Right
now I don't know where that stands. As
far as I know, it hasn't been reported yet because it is not quite out there
yet, but I think it falls clearly in the cargo scanner side of things with some
applicability of the people scanner side of things.
We
need a standards group to work on this.
DR.
CARDARELLI: I wanted to point that out,
the issue that we are talking about.
The van is not necessarily covered by all of the work that the ANSI and
Health Physics Society has addressed.
The vans and the cargo, it's a whole separate unit, and there is nothing
for us to evaluate what to do about that, and that is one of the challenges
that we are facing.
So,
the question is, that I would pose this to my committee members, as TEPRSSC, to
give guidance to FDA, do we feel it is necessary that we go down a similar
track to address these portable cargo vans and other devices that use isotopes,
accelerators, perhaps neutrons, to scan equipment, and if it ever gets to the
point where they mobilize it, that is what they are doing now where they can
use it for purposes other than scanning stationary equipment, and the public
could be involved.
What
standard do we compare that against?
Right now, there is none.
DR.
PLATNER: I just want to say I think
it's appalling personally that you might have a van coming down spraying you
with x-rays without having any idea it's there. I mean in the airport or in a
port facility or in a sensitive defense installation, I can certainly understand
it and you can get informed consent, but I guess I disagree when you said the
position was that informed consent shouldn't be specifically required.
I
think it should be. I mean it can be
incorporated into signing your airline ticket, but I think that informed
consent is an ideal mechanism for educating people about what the potential
risks are, and I think any Institutional Review Board for human subjects and
research would certainly want informed consent even with these relatively low
X-ray doses if you were in a research setting.
I
don't like the idea of dropping the informed consent for just education.
MR.
CERRA: I am not taking sides on this
issue, but just explain where that came from.
It is really based on other situations where people are exposed from
other sources without knowing it, and they never have to be told.
In
this case, the committee has said that they should be told because this is an
intentional exposure, however, because the doses are the same as what is
allowed to expose the general population from other types of source like if you
live next to a nuclear power plant, and so on, and so forth, then, it would be
inconsistent to require informed consent for that type.
It
also might scare the subjects unduly because if they are asked to sign, then,
they will think twice about it, and they, you know, maybe we should read this a
little more carefully, and then it would make the whole process kind of
meaningless because nobody would let themselves be scanned.
DR.
PLATNER: I guess I wasn't proposing
that the screening be optional for anybody that refuses. In certain settings, that is not reasonable,
but they ought to be able to turn around and go out, quit the job or ride a bus
or, you know, do whatever they choose to do rather than enter through that
security port.
MR.
CERRA: I think they always have that
option. Of course, there are consequences that you are not going to get on the
plane or whatever you are trying to get into.
DR.
PLATNER: Just another question that is
sort of along these same lines. Are
these images that are generated considered medical records or private?
MR.
CERRA: No.
DR.
PLATNER: It seems like before you take
a medical X-ray, you would have to have consent of the patient. Is that true here and what happens with the
data, is it covered by HIPAA?
MR.
CERRA: In all instances, at least in
this country, the images are not stored.
If someone passes the inspection, everything is erased right then and
there. The only time that Customs may
store an image is if they are needed, when they have found something for a
court case or something like that.
DR.
PLATNER: Is that inherent in the
machine? It seems to me that in a
future regulation, there should be a requirement that that data be blanked
unless it is to be used for certain processes.
Right now it is my understanding that when someone comes through Customs
and they think they have swallowed drugs in balloons or something, if they
refuse to give permission for an X-ray, then, they are set in a hospital room
and monitored until they know it has come through, so that they come up with
alternatives that don't require consent.
MR.
CERRA: Customs, in fact, does
that. Anytime they use even the
backscatter systems, they will ask the subject whether they would rather do
that or a patdown search that is voluntary from Customs part.
DR.
ROTHENBERG: I think we have had a lot
of discussion. I would like to thank
you for participating in the committee that drafted this report for the NCRP, I
think it's an excellent report and it has also got lots of additional
worthwhile educational material in there beyond the specifics of these devices.
I
get the sense that maybe our committee would like to encourage the CDRH to
certainly continue to be involved in any of these units which fall within their
purview and report to this committee updates on an ongoing basis.
Would
anyone like to add anything to that or say anything further?
DR.
CARDARELLI: Just perhaps some emphasis
on the lack of anything associated with the mobile cargo scanning type of
technology that is now being used, specifically, the non-person screening
technology. This uses 450 keV, the
accelerators, isotopes. It has been
beam mobilized. It is exposing a
variety of different environments.
DR.
ROTHENBERG: I am sorry?
DR.
CARDARELLI: There is no standard, not
even on exposure limits or leakage or anything like that per se for building
these devices to be used, but they are building them and they are selling them
and using them, and I think Dan had mentioned that that is what is being sold
in America right now, not necessarily these personnel screeners that we spent
all the time on.
So,
one of them we have now in place, a mechanism to identify the standards that we
are going to compare them against, but now we have a whole new technology, that
there is no such standard that applies to it, because it's brand-new, and that
would be the one concern that I am raising at this point.
MR.
CERRA: May I say something about
that? I think that in view of the work,
there certainly is a lot of interest in voluntary standard and we have a pretty
large group who have shown that they are willing to work hard at this issue,
and as this group goes on with their work, it may uncover some real concerns or
not concerns, and at that point, maybe it will be appropriate for this
committee or for us, FDA, to present to this committee about what has been
discovered and where we think the problems lie, and maybe at that point, you
can make a recommendation.
DR.
CARDARELLI: Let the record show that
there is an ANSI Committee or something that is starting to form to address
that issue.
MR.
CERRA: Right. It's not an ANSI Committee yet, it's a group who will be
proposing a new standard to an ANSI-accredited committee.
DR.
CARDARELLI: So, it is being
addressed. Thank you.
DR.
ROTHENBERG: Thank you very much.
MR.
CERRA: Thank you.
MR.
KACZMAREK: We were scheduled for an
open public comment session, but I don't think there is anyone from the public
who wants to make any comments. Is that
true? If so, raise your hand. If not, then, we will just skip that. We can take a short break or go right into
the committee deliberations.
DR.
ROTHENBERG: It is already 4 o'clock and
there may be some people with travel restrictions, so I would recommend, unless
there is a strong sense of urgency to have a break, that we continue with the
committee discussion, which I gather will not be terribly long.
MR.
KACZMAREK: We already sort of started
the committee discussion with the questions that Frank and Dan had. My feeling is that if the committee feels
that they have explored the security screening systems enough, maybe we should
revisit the medical X-ray discussion that Tom had and see if there is anybody
that wants to bring up anything about that.
I know we asked him some questions at the end of the talk, but maybe
somebody wants to bring up some more.
DR.
ROTHENBERG: I thought we had covered
everybody's concerns. Does anyone have
any other information or comments or questions for Tom?
Okay. I have one item I think you would be
interested in which doesn't concern the committee, but there is a new fluoro
regulation that has just been published by New York State for its health code
and if you haven't seen that, I brought a copy for you to look at. It is addressed more at the user and
measurement.
MS.
KANTNER: I know there were some
proposals or some recommendations for direction on I guess IEC standards. I was
just wondering what is the committee's role.
It seems like there have been questions relating to lack of completely
versus there seems to be in one case here there seems to be acceptance of it,
but yet there is still some uncertainty and the points were raised very clearly
in Tom's presentation.
In
kind of looking or considering forward, what would be next steps on the
committee level? I would like to get a
sense of what we would be involved in in trying to address these.
There
seem to be different layers and it doesn't seem like it is necessarily a
blanket, but, you know, we have X-ray activities going on here that started
many years ago, and I think in the circumstance here, there was no IEC at the
time, so there seems to be some questioning of enforcement, you know, items
that I think need to be looked at.
I
don't know if it is a very simple solution or what the options of looking into
that are.
DR.
ROTHENBERG: It sounds like it is very
complex in the sense that in some areas, it seems like it would be appropriate
to proceed along the international path and in others it may not work very
well.
MS.
KANTNER: That's true. I am not getting a strong sense of what the
issues are or how to even, as a member, pursue those.
DR.
ROTHENBERG: Where shall we start?
MR.
MYRICK: It seems to me that the FDA is
somewhat isolated on this issue. There
are other organizations like Underwriter's Laboratories and the FCC that have
adopted at various levels, whether it be just a reference to an IEC standard,
pulling some of the wording from the standard, or adopting the whole standard
in full. UL uses the full wording of the standard and then adds national
deviations, so they must have already dealt with the copyright issues and
enforcement issues. FCC has dealt with
the enforcement issues. So, I would
hope that the FDA would be at least trying to inquire of those organizations
how they have handled it and what they have done.
DR.
ROTHENBERG: It sounds like a good
suggestion. What would be the appropriate group to follow up on that?
DR.
SHOPE: Maybe I could add just a bit of
clarification. Actually, FDA is quite
active in the IEC activities, have discussions underway currently about how to
approach some of these issues, so I think we have a long history, in fact, in
the medical device arena, the recent--I lose track of which amendment it was to
the Food, Drug, and Cosmetic Act--but encourages the use of voluntary
standards, and FDA actually looks at all the available voluntary standards, not
just from IEC, but from other sources as the National Committee for Clinical
Laboratories or ANSI or others, and adopts those officially by publishing a
Notice in the Federal Register, and you can go to our web site and see which
standards have been adopted, but these are adopted, not as mandatory
performance standards, but as standards that can be used by manufacturers
submitting premarket submissions with regard to medical devices and what this
allows the manufacturer to do is rather than submit comprehensive test data in
their premarket applications to the FDA to support a marketing application for
a medical device, they can just say they conform to the following standards
that we have recognized and obviate any additional submissions to us.
We
then verify that during our factory inspections or our visits to them, so it
cuts down quite a bit on the submission paperwork because we have looked at
these standards, we know what they contain, and we say if you cite conformance
to that, that's enough to know about biocompatibility or that's enough to know
about what you have done with regard to electromagnetic or whatever, but those
are different than mandatory standards that are enforced and checked to make
sure there is exact compliance with the requirements in a mandatory standard
because many of these standards are test method kinds of things or other kinds
of issues that are not the kind of things that we enforce, but we do use the
international standards quite a bit in our medical device program.
I
think the thing that the Center is now looking at is trying to balance the
competing issues of demand, public health issues, resources, and the fact that
there now exists a whole body of international standards that weren't there in
the 1960s when we started in this business, and the question keeps coming up,
well, how do we best use what the rest of the world has worked together to do
and do we really need, in our standpoint, to do it all ourselves or can we make
advantage of this collaborative consensus work that has gone on.
I
think we are very early in this process at the Center in terms of thinking
through these things. There are a
number of legal issues, a lot of questions that remain that we internally
haven't sorted through, and you sort of got an early preview of some of the
discussions that are going on internally, and I think that we wanted to do this
in order to let people know that these discussions are occurring to give people
a chance to think about them, to give us your views and your comments and
problems that you may see in that area.
So,
it is very early in the process for us, I think, to determine what we are going
to be doing exactly for any particular product, but it is clearly something
that we are looking at to try to determine what makes sense from a public
health standpoint balanced against the resources that we have.
I
don't know if that helps any or not.
DR.
ROTHENBERG: I guess your intent is to
keep us informed.
DR.
SHOPE: Of course.
MR.
MYRICK: Like you said, it is early in
the process for you, but I believe that other organizations have gone through
at least some of this already, so to contact them and find out what the issues
were and how they resolved them, I think would be helpful.
DR.
PLATNER: I think it's great to look at
all these voluntary consensus standards, you know, it saves a lot of work and
writing regulations, but I think there is a real place for actual regulations
that are mandatory and I think it is important that FDA continue to work in
that arena, as well as working with the consensus committees.
IN
my experience, the consensus standards only really work in work sites where you
have got professionals or folks that are informed enough to know they exist.
I
think in a lot of smaller workplaces, which is the majority of workplaces,
there isn't anybody like that on staff.
DR.
LIPOTI: I would just make one final
comment on this, that the standards which are consensus standards frequently do
not involve all of the stakeholders, and one of the things that it really helps
is when you promulgate regs, it is a proposal and everybody can comment on it,
give input, and you respond to those comments.
I
go back to that Health Physics Society position statement that says you should
have some sort of consensus of professional, consumer advocacy, labor, business
organizations, academic institution, government agencies, and the general
public. You can't get all those people
together when you have a small group working through the issues.
DR.
ROTHENBERG: Comments?
MR.
CERRA: For what it is worth, to comment
on the last comment, that is very true.
The ANSI N43 committee, though, in their charter have makeup of what the
committee should be, and all those groups are represented, however, the purpose
of the committee is for radiation safety, and they don't make value society
judgments, so it is hard to find a group when you asking to consider
justification of non-medical versus medical.
MR.
KASSIDAY: One other thing that we are
trying to do, in fact, later this month, is present some of these issues to a
group called ISCORES, which is an interagency federal meeting on radiation
safety, and try to get them to at least be aware of the issues and be a player
in this, so that it is uniform throughout all the agencies. So, we have some hope of giving them the
right information, so they can make informed decisions.
MR.
KACZMAREK: I just want to reinforce
what Tom was saying. I don't think the
committee should get the impression that the FDA is going to go away and wipe
out everything that is in Part 1000 immediately, because as a matter of fact,
Dan and Frank were talking about writing new regulations where none existed,
so, in fact, you have got kind of a mixed bag there.
As
Tom was saying, we are just beginning to discuss these things ourselves, and we
have the same concerns that, for example, Jill raised about the regulations
making from consensus standards bodies.
We are going to be discussing these in the months ahead and there will
be more opportunity to discuss them I think.
DR.
ROTHENBERG: Does anyone have other
items of concern or future recommendations for the committee?
MS.
BARR: This is just a minor comment on
Tom's presentation before we leave that topic, which I said to him, and it's
just food for thought for the committee, since you seemed to enthusiastically
endorse the idea of having a dual dose display with cumulative dose, I just
wanted to point out as a radiologist who has done thousands of fluoroscopic
procedures that the way the proposal is written now, all you would have to do
to get the cumulative dose display is take your foot off the pedal and every
time you did that you would have a cumulative dose display.
It
might be a disincentive to have the cumulative dose display all the time
because you don't have to take your foot off the pedal, you can just merrily,
fluoroscopically go along. That is just
food for thought when that comes around again.
MR.
KACZMAREK: At this time what I am going
to do is mention that we have some committee members that are going to be
leaving us this year, so this is probably going to be their last meeting since
I don't think there are going to be any TEPRSSC meetings for the rest of the
year.
Three
of those people are here. I have a
suitable recognition of their achievements or their efforts.
Dave
Lambeth, this is his last year on the committee, Michele Loscocco, and Larry
Rothenberg. I am going to be giving
them these plaques and letters, which are letters of appreciation.
The
other people that are leaving are Maureen Murdoch Nelson and Bob Pleasure.
Typically,
normally, we discuss when we might want to have the next meeting. I don't know whether FDA will be ready to
have a meeting in the spring, for instance, of 04. Probably the earliest time
would be the fall of 04.
But
are there any time, does the committee prefer the spring or the fall, for
instance, or July? Washington in
July? No.
What
I am going to do then is just assume that this time frame was probably good and
if we do meet in 04, probably pick around this time. Of course, I will be in touch with everybody on the committee. Also, some of the slides that were shown
were not available until just the time the person was showing them, so I am
going to collect them from the speakers and e-mail them to the committee
members after the meeting. I am also
going to see that they get included in the postings on the web site from the
materials from the meeting.
I
guess we can close the meeting unless somebody wants to bring something else
up.
DR.
ROTHENBERG: I would personally just
like to thank Rick and staff and all of our presenters for their excellent
presentations and thank you all for the opportunity to be involved in
this. I have always learned new things
when I have come to this meeting and enjoyed interacting with some people that
I don't see in my normal rounds in the medical physics AAPM RNSA rounds of
meetings.
Personally,
I am very pleased to have been part of all this.
DR.
LAMBETH: I will second what was very
eloquently said and I agree. Thank you
very much.
CDR
LOSCOCCO: I will third that I guess.
DR.
ROTHENBERG: Thanks to all the committee
members for taking time out of your busy schedules to participate in this
activity.
MR.
KACZMAREK: I want to second that and
thank everybody for coming and giving us the benefit of their opinions and
expertise which we really value.
With
that, I am going to close the meeting. Consider the meeting adjourned.
[Whereupon,
at 4:20 p.m., the meeting was adjourned.]
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