Wednesday, October 1, 2003


8:30 a.m.











Food and Drug Administration

Hilton DC North/Gaithersburg

620 Perry Parkway

Gaithersburg, Maryland







General Public


Lawrence Rothenberg, Ph.D., Chairperson

Richard Kaczmarek, Executive Secretary

Jane Benson, M.D.

James W. Platner, Ph.D., CIH




David Lambeth, Ph.D.

Michael Caswell, Ph.D.

Kimberly Kantner, BSc

Wayne Myrick, MS




Kiyohiko Mabuchi, M.D.

Jill Lipoti, Ph.D.

Michele Loscocco, MS

John Cardarelli, Ph.D.





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


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.


    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, 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. 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.]


[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.


    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.


    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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