SGDEPARTMENT OF HEALTH AND HUMAN SERVICES

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