AT DEPARTMENT OF HEALTH AND HUMAN SERVICES

> UNITED STATES FOOD AND DRUG ADMINISTRATION
>
> CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
>
> ADDITIVES AND INGREDIENTS SUBCOMMITTEE
>
> OF THE
>
> FOOD ADVISORY COMMITTEE
>
> LATEX ALLERGY
>
> Wednesday, August 27, 2003
>
> 8:10 a.m.
>
> St. Regis Hotel
>
> 923 16th Street, Northwest
>
> Crystal Ballroom
>
> Washington, D.C.
>
> PARTICIPANTS
>
> Johanna Dwyer, D. Sci., Chair
>
> Richard Bonnette, Executive Secretary
>
> MEMBERS
>
> Jeffrey Blumberg, Ph.D.
>
> Goulda Downer, Ph.D.
>
> Lawrence Fischer, Ph.D.
>
> Anthony Gaspari, M.D.
>
> Robert Hamilton, Ph.D.
>
> Rachel Johnson, Ph.D.
>
> Brandon Scholz
>
> Steve Taylor, Ph.D.
>
> J. Antonio Torres, Ph.D.
>
> **C O N T E N T S**
>
> Call to Order
>
> Committee Chair 4
>
> Invited Comment from Consumer Advocate
>
> Lise Borel, DMD 5
>
> Questions of Clarification 23
>
> Invited Comment from Latex Glove Industry
>
> Charles Reed, M.D. 35
>
> Questions of Clarification 51
>
> Invited Comment from a Retail Food Provider
>
> John Schulz 96
>
> Questions of Clarification 105
>
> Public Comment
>
> Doris Rittenmeyer 117
>
> Invited Comment from a State with Latex Food Service Prohibition
>
> Marie Stoeckel (by telephone) 125
>
> Questions of Clarification 135
>
> Public Comment
>
> Wava Truscott, Ph.D. 143
>
> Rochelle Spiker 172
>
> Karen Jacpor, M.D. (read by Lise Borel) 178
>
> Christine Andrews 186
>
> Esah Yip 207
>
> Questions of Clarification 192
>
> Invited Comment from a State with Latex Food Service Prohibition
>
> Donald Harrington (by telephone) 220
>
> Questions of Clarification 230
>
> Committee Discussion 236
>
> Adjournment 312
>
> [P R O C E E D I N G S]{.underline}
>
> **Call to Order**
>
> DR. DWYER: Good morning. This is the second day of our meeting on
> natural rubber latex. Thank you for coming a little early. I am going
> to just acknowledge and then the committee will receive in the course
> of the morning eighteen pieces of written comments that various people
> have submitted for our perusal. Twelve are opposed to natural rubber
> latex gloves in food service, three are in favor, two are neutral
> according to the staff. So we may want to peruse them as we reach the
> discussion.
>
> Mr. Bonnette has done a wonderful job of rearranging our schedules to
> try to get at least some of us out today. I am going to stay so there
> is no need to hurry in terms of anything you wanted to get to me. I
> will be here all evening.
>
> But, Mr. Bonnette, would you fill us in on those arrangements and when
> we think is a target for leaving.
>
> MR. BONNETTE: I can only offer my estimation. I am sure, when we
> actually get into the program today, we will know a little better. But
> just looking at how I have been able to move speakers up from the
> afternoon, depending on how long the discussion period lasts, I think
> we will certainly be done around the usual time, probably 5:00 or
> 5:30.
>
> DR. DWYER: Thank you, Mr. Bonnette.
>
> What we will start with this morning, then, is Dr. Lise Borel, who is
> a consumer advocate and who is going to give us an invited comment on
> her views on this important problem.
>
> **Invited Comment from Consumer Advocate**
>
> DR. BOREL: Good morning. I would just like to offer a couple of
> comments about how much I appreciate being invited to speak. As I was
> reviewing what occurred all day yesterday, and it was a long day, I am
> amazed at the process that our country goes through to ensure public
> health and public safety. It has been a really, really beneficial
> experience for myself and I hope for all of you to be part of this
> process.
>
> It is new for me so I am kind of a little wide-eyed, but I am sure for
> all of you, you sometimes take a moment and are just happy, like I am,
> that these things do occur. So thank you.
>
> My name is Lise Borel. I have practiced dentistry for ten years and I
> was diagnosed with latex allergy in 1994. What I would like to do is
> offer a perspective from the other side of the glove, as a consumer
> today. There is not a lot writing. It is a lot of pictures because I
> would like to put a face to this issue.
>
> This picture really struck me as some data from this company that
> provides gloves to many industries including foods. But gloves are a
> controversial subject for many, many reasons; to wear them or not to
> wear them, what kinds of material they are made from and the impact
> that it has on end users and those on the receiving end of the gloves.
>
> My perspective is on the receiving end of the gloves. These are people
> that are affected by latex allergies. Whether you are like Brock
> Williams, here, in the upper left, and who was born with spina
> bifida\--and 4,000 children are born each year with spina
> bifida\--this is a significant impact on healthcare when latex-safe
> environments and safe food is not available to them.
>
> The gentleman in the top middle was one of the guys that was serving
> food at a local food festival. I took some pictures of individuals
> wearing latex gloves at this food festival and he goes, \"Look at my
> eyes. I have got hives and I sneeze and my nose runs whenever I wear
> these gloves.\" This was out of the blue. I was just taking pictures
> for another presentation. So he is probably one of those unknown
> individuals who may be sensitized to natural rubber latex.
>
> Stacy over there is a healthcare worker. That is what happens to her
> when she walks into a room where powdered latex gloves are used.
>
> Debbie Anderson was referred to yesterday by Dr. Tomazac. She is not a
> healthcare worker. She was a teacher and she underwent multiple
> surgeries and developed latex allergy through surgical exposure. Her
> event that led to an awful, awful series of events, was that she spent
> the day in the ER with her niece. She took great care not to be
> directly contacted with latex, but they used powdered latex gloves in
> the facility and people that were handling her niece work latex gloves
> at all times.
>
> She took turns with her sister holding the baby and went home and had
> some typical allergic symptoms, took a Benadryl. But then she ate a
> banana. She was not informed by her physician that it is
> cross-reactive.
>
> The exposure during the day and then the banana at night caused her to
> anaphyax. Her family members were not trained with Epipen and they
> didn\'t know when to use it. So what they did was CPR, and that did
> not work. They used the Epipen after twenty minutes. You will see what
> happened to her later because she did not receive the proper care.
>
> Lieutenant Harold Henderson is a healthcare worker who died in, I
> believe, 1997, 1998. He is one of the few reported cases of deaths
> associated with exposure to latex gloves.
>
> That little boy just represents the poor kid in Italy eating those
> cream donuts for this experiment.
>
> When the original rules were made and developed, they basically
> remained developed in an era where latex-glove use was not prevalent
> outside of the medical community. You didn\'t see people wearing latex
> gloves to do gardening. You didn\'t see Martha Stewart wearing latex
> gloves to stuff a turkey. You just didn\'t see it. It wasn\'t done.
>
> So, at this point, with the advent, and the very sudden advent, of
> latex allergy, it is a good time to take another look at the rules and
> the regulations that are in the books and reevaluate where we stand
> based on the products that are now used to commonly in today\'s world.
>
> Because there are other products on the horizon, alternative products,
> and one of them happens to be an alternative natural rubber latex
> product from the Guayule shrub, I wanted to be very specific for the
> terminology. We are talking about Hevea. It is very important that we
> remember that because, in the future, there are going to be other
> sources of natural rubber. Those are already in the beginning stages
> of manufacturing.
>
> Latex allergy surprised everybody. Anybody who is diagnosed with it,
> particular me\--I, as a dentist, if anybody ever told me you could be
> allergic to gloves, I would have laughed. It is ridiculous. Sadly, the
> opposite is true. It is possible and it significantly impacts people.
>
> This is what happened to Debbie because the EMS only had
> latex-containing medical devices. The ER only had latex-containing
> medical devices. She suffered severe anoxia. She has permanent brain
> damage. She is blind and she is fed through a feeding tube and she
> will always be cared for. Her twins, I believe, are about twelve years
> old now.
>
> Despite some of the coverage that has been in the media over the years
> and despite the efforts of organizations and government agencies,
> truly latex-allergy awareness to be improved. This is a huge issue. If
> we talk to people are not with in the healthcare community, they
> don\'t have a clue. \"Oh, yeah; I saw something on t.v. or my aunt
> says she has latex allergy.\" But they don\'t have a good idea or a
> good education or a good awareness of what the consequences can be.
>
> This is from NIH. These are the statistics that are available to us
> now. I am sure there are some that would probably disagree with these,
> but I believe that these are done with careful consensus and careful
> review of the literature.
>
> We talked about cross-reactivity yesterday. It is an issue but, if you
> review the literature that is out there, I am sure most of you will
> agree that the percentage of people who are cross-reactive to foods,
> that have latex allergy that are cross-reactive to foods, is around 30
> to 35 percent. It is not an overwhelming majority. It does not happen
> in the majority of the cases.
>
> Then we spoke briefly about people who had food allergies that would
> then cross-react back to latex. This percentage is even less. So
> cross-reactivity is something that has to be considered in the studies
> that are available, it is not the big picture. The big picture is
> exposure to Hevea natural rubber latex.
>
> We talked a little bit yesterday about types of reactions and how can
> you predict what the reaction will be. The problem is that you can\'t.
> Within individuals, they don\'t always react to the same exposure
> level at the same time. It is often an issue of how many times that
> person has been exposed over the past week or over the past month that
> heightens their sensitivity. So it does depend on individual
> sensitivity. It does depend on how contact occurs.
>
> It is very important as a patient and, as a consumer, to learn about
> the big things to worry about and the little things to worry about so
> that you don\'t walk around thinking that everything is going to cause
> you a problem because it simply isn\'t so.
>
> We know that latex that contacts mucosal tissues is one of the biggest
> issues. Also, literature cites inoperative reactions
>
> So when I was diagnosed, I was given that lovely list of 40,000 things
> to avoid. I looked at it and I went, like, what do you do with this.
> It took me a little while. What I realized is how products are made.
> It kind of gave me some guidelines about what the importance of what
> these issues were.
>
> I don\'t worry about rubber bands. I don\'t stick them in my mouth and
> suck on them, but I don\'t really worry about them. I do worry about
> the gloves because of the way they are manufactured. They are a
> largest source of bioavailable allergens out there. The other stuff is
> out there but, believe me, it just is not that much of a risk issue.
>
> We learn about exposure routes. When you are a latex-allergic patient,
> believe me, it changes everybody\'s perspective and it changes how you
> travel through life. You do a lot of thinking about the \"what ifs.\"
> But, with time, you know that you can learn to take care of yourself.
> You have the appropriate medications. Your physician gives you the
> appropriate information and you learn to look out for hidden sources
> of latex and you learn what to do in the event the you are exposed to
> mild reactions.
>
> This allergy is totally manageable. What is not so manageable is what
> other people do in their everyday life that you are not aware of. Dr.
> Taylor, you brought up a great point yesterday. I think you talked
> about the lettuce that was fixed in a processing plant and then went
> on to a facility that didn\'t use latex gloves. How do you know what
> the source was?
>
> Many times, it is impossible to trace the source of exposure and
> sometimes you just stop trying. But we know that nonmedical glove use
> is just flying off the charts in terms of what is imported into the
> country. This is a huge increase every year and this represents
> billions of dollars. This is a huge industry with a lot of financial
> incentives to keep producing more gloves.
>
> That is my auto mechanic. He uses latex gloves. Then that was a food
> festival. I went into a doctor\'s office and I found this cartoon and
> I started to laugh until I realized that the woman that was cleaning
> the office was looking a magazine wearing her latex gloves.
>
> This are situations that do not expose the users to bloodborne
> pathogens. There just is no rationale reason for wearing a glove that
> has potential to cause latex allergy. So, while I know there is a
> separation between workers and consumers, I am a worker but I am also
> a consumer. These workers are consumers as well, and that is something
> to consider. We want to be sure that we are not sensitizing other
> populations with pretty much indiscriminate latex-glove use.
>
> We talked a little bit yesterday about how gloves are relabeled or
> repackaged. I first found this out back in 1996, 1997 and I was
> appalled because I looked at how strong the measures or the guidelines
> were through the Center for Devices for gloves. But then the same,
> exact, product could be sold as a food-service glove and have
> absolutely no controls and very little regulations.
>
> I find latex gloves from farm to table. I worked in a farm market a
> couple hours a week when I was in between jobs just because I happen
> to like the farm. I go back into the barn and he has a case of
> powdered latex gloves. I said, \"What are they for?\" He says, \"Well,
> we wear them when we attach the milking machines to the cows and I
> wear them when I pick the strawberries because my hands itch from the
> strawberries.\" He says, \"This year, we just have them there for
> anybody.\" It was, like, a self-serve farm. You could pick your
> strawberries and go out and pick a pumpkin. You could do what you
> wanted. So people were wearing latex gloves to pick strawberries.
>
> So no matter where you are in the process from farm to table, there
> are latex gloves. It is a simple fact of life these days.
>
> Sometimes, they are in boxes and sometimes they are labeled. And
> sometimes, like in this group, you can\'t see very clearly, but the
> gentleman on the far right over there, that is a garbage bag full of
> latex gloves. What he said the restaurant does is they get their
> gloves from the distributor in big barrels, like you see in Home
> Depot, where they throw like tools that are on sale.
>
> There was a barrel this big that was full of any number of brands of
> gloves. There is absolutely no way to track which one is good, which
> one doesn\'t have powder, which one doesn\'t have high protein because
> they are all thrown in the basket. This is what they give these
> individuals to wear.
>
> I would say, out of this food festival, over three-quarters of the
> booths, the personnel were wearing latex gloves. That is a big
> percentage. When you ask them why they are doing it, they are saying,
> \"We don\'t want to get our hands messy.\" There is very little
> indication that they are wearing it to protect the consumer.
>
> Reporting reactions; this was an issue yesterday. I have to tell you
> that I am the author of the website that listed Dr. Klontz\'s
> information. But I would like you to understand the context of which
> his name was listed. I am a huge advocate of civic responsibility. I
> believe in doing the right thing for the right reason and I don\'t
> believe that we can do anything without proper information.
>
> When you go down the list of other agencies that are dealing with
> latex-allergy issues, there are very specific reporting instructions
> and programs. When you go to the FDA CFSAN site, there is not, as a
> consumer. I know that there are programs in place. They also direct
> you to your district office to report food-related reactions.
>
> I have dialed our FDA district office three times, now, in
> Philadelphia. I have never received a phone call back. So, as a
> consumer, this is a bit frustrating to have important information and
> no place to put it.
>
> So this is exactly what was on the website. We explained how to report
> reactions depending on who it was and where the reaction occurred. You
> can see the different categories. We gave a general description of the
> reporting programs that were available and the contact information.
>
> This is an example of FDA MedWatch. This is their MedWatch program for
> reporting adverse events for medical devices. Latex gloves are medical
> devices if they are labeled as medical gloves.
>
> This is what we found. Just about everybody had very formal reporting
> programs with very detailed reporting instructions. When I went to FDA
> CFSAN, I had a difficult time finding anything. I knew at the time
> that FDA was looking at this issue. They had sent several documents in
> and Dr. Klontz was receiving comments. That was basically how that
> whole thing got started. But it was just not his name. It was
> everybody in there. It was in the context of how to report reactions.
>
> This is what you find when you go to www.fda.gov. There is a section
> on how to report problems regulated by FDA. One of the sections is how
> to report non-emergencies with food. This is what they do. If you
> click on that blue writing, it will take you to the list of district
> offices. You then make a phone call to the district office and,
> hopefully, they call you back. That is pretty much what I could find
> in terms of reporting.
>
> I would like, because some of the information that I feel is very
> important to this issue\--I would like to review what is out there
> from other government agencies in terms of recommendations for food
> handlers. I know it is work-related and I know that your
> responsibility is to stay on topic, but the science behind their
> decisions states the same.
>
> This is developed by the American College of Allergy, Asthma and
> Immunology and the American Academy of Allergy, Asthma and Immunology.
> While this went through some painful discussions, from what I
> understand, the general gist of their recommendations is that latex
> gloves should only be used as mandated by universal precautions or
> standard precautions, as they are called now.
>
> They discourage the use to limit the level of content to anybody
> wearing these gloves. It is a very consistent message. Whether you are
> talking about the professional organizations, whether you are talking
> about CDC NIOSH, whether you talking about OSHA Technical Information
> bulletins, the message is the same.
>
> In a 2002 publication that was in the Journal of Allergy and Clinical
> Immunology, again, there is a general review of latex allergy, like
> how far we have come and where we are now. The message stays the same.
> It doesn\'t change.
>
> There was a reference to a worker\'s compensation article yesterday.
> Just to provide another published perspective, I wanted to make sure
> that you knew that there was other information available. The people
> who published this worked very closely with the worker\'s compensation
> cases that were accepted and what the eventual cost of these were. I
> believe, for one of the individuals that they use as an example in
> this paper, the cost was close to \$1 million.
>
> That was not just their case. It was retraining. It was getting people
> in to replace the person who was out of work because of their issues.
> The overall costs are close to \$1 million for healthcare workers.
>
> Oregon has prohibited latex gloves for food handling. This ad was
> place in the Oregonian, questioning, I guess, the wisdom behind that
> decision. As far as I can tell, it is a matter of perspective, whether
> you are one of the millions of people, millions of Americans, affected
> by latex allergy who are instructed by their physicians to avoid,
> avoid, avoid latex or whether you are industry and are in it because
> that it your job and that is how you keep going.
>
> A perspective depends on what side of the glove you are on. I just
> want you to remember that when you are thinking through all the
> science is this issue has a face and has a couple of million of them.
> These faces are counting on you to make the correct decision.
>
> I want to thank FDA for putting this information in the Food Code.
> Believe me, when I was doing advocacy, it has made my job a lot easier
> because it brings the issue where it belongs. It brings it from, \"I
> think there is a problem,\" to, \"There is something published in the
> Food Code.\" So thank you very much.
>
> Everything has changed. There is a big difference between 1963. We are
> all a lot older. Some of the us have healthcare issues now, but the
> fact remains that it is time to look at this in the context of where
> we are now in terms of glove use and what has happened to people over
> the years in terms of increased exposure and increased sensitization.
>
> Any questions?
>
> DR. DWYER: Thank you, Dr. Borel.
>
> **Questions of Clarification**
>
> DR. DWYER: Are there questions?
>
> DR. BOREL: That was easy. Thank you very much.
>
> DR. DWYER: Just give them a moment.
>
> DR. FISCHER: I can ask one. You mentioned that cross-reactivity is not
> nearly as prevalent as some people think.
>
> DR. BOREL: Correct.
>
> DR. FISCHER: Where did you get that information, or how did you come
> to that conclusion?
>
> DR. BOREL: There is a specific article that I don\'t have with me but
> I would be happy to get it for you by Schirer. When you look just
> through a literature review, it is fairly consistent. I am sure there
> are articles out there that cite higher numbers just like there are
> article out there that cite higher prevalences and incidences of latex
> allergies.
>
> But I took the most articles. I did a lot reading and reviewed most of
> the literature out there and this is what I was coming up with.
>
> DR. FISCHER: Thank you.
>
> DR. DWYER: This is Johanna Dwyer. Were you given a list by your
> physician about all these different foods to avoid?
>
> DR. BOREL: That came out of St. Christopher\'s Hospital in
> Philadelphia because they deal with spina-bifida children so much. So
> this was a list that had medical equipment and household products. I
> have to tell you, the lists are extremely inaccurate. If you went by
> those lists, you would be mental. You really would, because they kind
> of assign the same priority in terms of avoidance.
>
> We know that there are very specific products that cause the majority
> of the reactions. That is what I personally think about. I mean, I
> honestly don\'t put a lot of thought into anything except for my
> medical care, my dental care, gloves and balloons. That is pretty much
> it.
>
> DR. DWYER: Mr. Scholz?
>
> MR. SCHOLZ: Do you have education programs around here for either
> consumers or workers? Is there anything on the front end before they
> find out that they are allergic to latex? Are there education programs
> or consumer programs that just kind of reach out and increase
> awareness?
>
> DR. BOREL: There are. Whether or not they are distributed and utilized
> is anybody\'s guess. There is an excellent tutorial on the NIH site.
> Dr. Kenneth Kelly out of Wisconsin has done some work. Johns Hopkins
> has information. The information is out there. It is just a matter
> of\--when it involves you, you tend to look into it and, when it
> doesn\'t, you tend not to.
>
> DR. DWYER: Thank you.
>
> Dr. Johnson had a question.
>
> DR. JOHNSON: Thank you very much.
>
> I am still really struggling with the difference between direct
> contact with latex by the food-service worker\--we heard a lot about
> that yesterday\--and then the contamination of food that, then, an
> allergic person consumes. I wonder if your advocacy work\--it sounds
> like you are probably in contact with a lot of people that have latex
> allergy.
>
> DR. BOREL: Yes.
>
> DR. JOHNSON: Can you give us, even though it is anecdotal\--it seems
> like the data are limited. You didn\'t present anything new, really.
> So, anecdotally or in your work with people with this allergy, in your
> consumer-advocacy work, do you advise people when they go to a
> restaurant to ask if the food has been prepared with latex gloves?
>
> DR. BOREL: I understand what you are saying. Let me give you an
> example. There is a dermatologist in Florida. His big thing is bagels.
> Everything is on the bagel. He used to get his bagels at a little shop
> just down the road but it closed. So he went to Einstein Bagels. I
> know him through association with a nonprofit organization. He has
> been very instrumental in increasing awareness in the State of
> Florida.
>
> He started getting his bagels at Einstein. The first time he went in,
> he ate a bagel and he started to itch. His eyes started to water, but
> he didn\'t really see anybody wearing latex gloves. This happened two
> or three times. He gave me a ring and I said, \"Tell me what you have
> been doing that\'s different,\" because he has been basically
> reaction-free for quite a while.
>
> He told me about the bagel situation. But, he said, \"I don\'t think
> they are wearing latex gloves.\" So he went in again and didn\'t ask.
> He bought himself a bagel and he had anaphyaxed and ended up in the
> ER. His blood pressure dropped. His airways were swollen. He had hives
> and he had very distinct wheezing.
>
> When he finally got out of the hospital, I think they admitted him
> overnight, he called Einstein and found that they were wearing latex
> gloves in the back and it wasn\'t something that he could see.
>
> So what I advised him, based on his experience, was to, \"Before you
> eat food, ask to see the box of gloves that they are using. Even if it
> is not in the front, ask if they use them and then ask to see the
> box.\"
>
> In my own personal experience, I call sometimes ahead to see if they
> use latex gloves. I worry particularly about salads because of the
> wetness issue. I think that is one of the biggest risk factors. They
> will say, \"No; we don\'t use them,\" or they will think I am a health
> inspector and they will say, \"Oh, yes; we wear them all the time.\"
>
> To double check, ask to see the box. Even though they don\'t really
> like it, I have to say probably at least half the time, they are latex
> but they call them plastic. There is very little understanding of
> glove material, of appropriate gloves for appropriate tasks. There is
> very little education and understanding among food workers unless you
> have a problem that is like in Oregon where they make an effort, a
> very distinct effort, to go out and educate people in the
> food-handling business.
>
> So, in general, yes; we do tell people to ask. I am not saying it is
> the most common route of exposure for reactions. I am not saying that
> it is most common cause because it certainly is not. But it is
> something that is avoidable and we are told, as patients, to avoid,
> avoid, avoid. I count on safe food. I live in America where a lot of
> measures are taking place to make sure our food is safe. Safety for
> myself and millions of others means food that is not contaminated with
> Hevea natural rubber latex.
>
> DR. DWYER: Just one last question. I keep struggling with the issue
> of\--this is really considered a medical device, I guess, under the
> law, but all of the people that we see with various food allergies,
> including peanut allergies\--I have heard some very good presentations
> by peanut people, by anti-peanut-allergy people, by the allergy
> people\--the question is how far can society go to help folks who have
> the kinds of problem you have because there are many other people who
> have other conditions. It is a struggle and I think we all want to do
> the right thing.
>
> DR. BOREL: It is a struggle and, of course you want to do the right
> thing. Believe me, I am not sitting in those chairs. You have a very
> difficult job. I believe in prevention. An ounce of prevention to me
> is worth everything. There are alternative ways to handle food that do
> not jeopardize or put at risk people with latex allergy.
>
> What I would also like to see happen is a move should be made to
> prevent further sensitization for food-service workers. A great
> example is I was in an airport. There is a Macdonald\'s there. There
> is a sixteen-year-old girl behind the counter and she has on vinyl
> gloves and then latex gloves.
>
> I said, \"Why are you double-gloving?\" She said, \"Well, I have an
> allergy to latex.\" I said, \"Oh; did you go to the doctor?\" And she
> said, \"Yes.\" But my manager makes me wear latex because it is
> required by law.\"
>
> So this is a general understanding and this is what we are running
> into. She is sixteen years old. I would be furious if my
> sixteen-year-old daughter, who has a history, a six-year history, of
> ten surgeries, who has other allergies, is told to wear latex gloves.
> She is one of those individuals who should not wear latex gloves and
> not be exposed.
>
> It is a precautionary measure, I understand, but the situation is out
> there where glove use in the food-handling industry is escalating
> unbelievably. A lot of these end users are very, very young. These are
> our teenagers. We don\'t need to make more patients. We really don\'t.
>
> DR. DWYER: Thank you very much.
>
> Who else? Dr. Gaspari?
>
> DR. GASPARI: You mentioned early in your presentation about new
> sources of rubber. I want to make sure that I understood you
> correctly. Are you referring to synthetic rubber gloves or there are
> things on the horizon that we should be made aware of?
>
> DR. BOREL: Absolutely.
>
> DR. GASPARI: Can you expand on that a little bit?
>
> DR. BOREL: Believe me. I am not an expert on this but I know what I
> read. In Science News since, I think, 1992, 1993, there has been a
> group out of USDA that has been looking to find other sources of
> natural rubber. One of the ones that seems the most promising is
> Guayule. I know that their crops are planted. They are out in Arizona.
> They are just about up to production speed.
>
> So you are going to have other natural rubber products on the horizon
> and they are making gloves and they are doing medical devices. They
> are taking the lessons learned from the Hevea natural rubber latex
> situation. They are not going to be using any powder, from what I
> understand, and they are going to do their utmost to limit the level
> of total protein so that we don\'t have the same sensitization issues.
> But it is called Guayule.
>
> DR. DWYER: Thank you.
>
> Any other questions? One more. Dr. Hamilton?
>
> DR. HAMILTON: We know of three states that have basically banned latex
> gloves for food handling. Can you speak to the issue of latex gloves
> used in grocery stores that actually come in contact with food but
> that we haven\'t really considered in any of our discussions?
>
> DR. BOREL: They are always considered, but I have to tell you that,
> once grocery chains have an understanding, are given the NIOSH report
> and understand, they are concerned about their consumers but they are
> more concerned about their workers, evidently. It is very easy to get
> a grocery chain to switch. As long as the cost is the same, they just
> don\'t care. But it is another source of exposure for food handling.
>
> DR. DWYER: Anybody else? See, I told you if you just stood there, they
> always ask questions.
>
> DR. BOREL: I\'m sorry. I forgot I was the first one. Thank you very
> much.
>
> DR. DWYER: Thank you very much. We are grateful you came on such a
> rainy, miserable day.
>
> Our next speaker is Dr. Charles Reed who is Professor Emeritus of
> Medicine at Mayo Clinic. Mr. Sholz, he lives far north of you in
> Wisconsin, way up in the boonies. He is also a distant relative of
> Walter Reed. I learned all of this at breakfast.
>
> **Invited Comment from Latex Glove Industry**
>
> DR. REED: Again, I would like to echo the sentiment of the
> appreciation of being here and having the opportunity to speak with
> you. I am listed as a representative of the glove industry but I would
> much prefer to think of myself as a representative of a group of
> patients who have no other one to speak for them.
>
> As a matter of fact, most of these people probably wouldn\'t want me
> to speak for them, but I am going to anyway.
>
> These are the three points I want to bring to your attention. The
> first one is that allergy to latex is a very real thing, as we all
> know. This came to our attention at Mayo back in the 1980s. I remember
> the first patient I saw was a laboratory technician in the blood bank
> typing blood who has asthma, obviously, at work.
>
> We tried, at the time, to associate her occupational asthma to
> exposure to the proteins, enzymes, that were used in blood typing
> unsuccessfully. It took me almost two years to tumble to the fact that
> the problem was the rubber gloves that she was wearing.
>
> After that, we saw more and more of our own employees in our allergy
> clinic with allergic reactions to latex. Thanks to very specific
> things that we have at Mayo that are not available elsewhere, we dealt
> with the problem.
>
> These things are several. First of all, we had the Allergic Disease
> Research Laboratory which had the technology to measure the amount of
> allergenic proteins of any kind and any source. We could measure it in
> the gloves. We could measure it in other rubber products and we could
> measure it in the air of the operating room or other areas around the
> institution.
>
> In my handout, I have reference to a number of papers dealing with
> what we found at the time when this was an issue. This was more than
> ten years ago.
>
> The other thing that is unique at Mayo is that the whole institution
> has one board of governors, one set of administration and it is
> possible to do things that go clear across the whole medical
> situation. So a multidisciplinary committee was appointed to look into
> this problem and recommend solutions.
>
> They did so. This included people from anesthesia, allergy, purchasing
> and so on. What was done was a decision to measure the amount of
> allergen in the products that we bought and buy only products with low
> allergen concentration.
>
> This was quite successful. The number of new patients that we were
> seeing dropped almost completely off and most of the patients, or all
> of the patients so far as I know, went back to work without any
> difficulty. This was about the mid-1990s, 1997, 1998, somewhere along
> in there but about that time, the patients that were coming to the
> Allergy Clinic at Mayo for latex allergy were very different.
>
> These were people who were frightened of their environment, who had
> been so scared by the possibility of these serious reactions that it
> was the fear that was disabling them. It is like they had the
> environmental intolerance syndrome. They were totally disabled because
> of this notion that the slightest exposure to latex is going to kill
> them.
>
> This is a very real fear. The reason for the fear isn\'t real, but the
> fear is real. The source of the fear is some of the statements that
> you have been hearing. Here is an example. There are two points I want
> to bring out. One is the use of the word \"sensitized\" to refer to
> the frequency of the disease and the other is the statement about what
> happens here
>
> Now, it is quite clear that when latex is introduced into the
> circulation in large amounts, anaphylaxis occurs. It is quite true
> that there have been, in the medical literature, two fatal
> reactions\--two. These things do happen, but the statements like this
> greatly exaggerate the fear that some of these individuals have.
>
> The word \"sensitization\" is a useful one. It is easy to do. In
> epidemiologic studies, you can collect blood and test the blood for
> antibody to anything you want to test it for including latex. If you
> do, you find people, a lot of people, with antibody to latex. This
> does not mean that they necessarily have the disease.
>
> As I said, when the exposure is appropriately controlled, people can
> work without difficulty. But these people that are afraid have been
> frightened by this word \"anaphylaxis.\" Anaphylaxis is an ambiguous
> term. For example, back in the early days at Mayo when we were first
> trying to work this problem out, one of my patients was the head nurse
> at the Transplant Unit Ward in the hospital. She had obvious allergy
> and asthma at the time she was working.
>
> We were trying to develop appropriate skin-test reagent and had a
> series of reagents that we had prepared from rubber gloves. We
> skin-tested her to five or six of these different glove extracts with
> intradermal skin tests. As a result of that, she broke out with
> flushing. She was a blonde and had light skin and flushed easily, but
> she was obviously having a systemic reaction to the skin test
> material.
>
> This is not anaphylaxis. This is a systemic reaction. It is relatively
> common in allergy clinics but it was a result of the injection of an
> unreasonable amount of allergen.
>
> The word \"anaphylaxis,\" properly defined, is this. Again, it is a
> very real problem and does exist. It has occurred from latex and it is
> a very real event. But it doesn\'t happen very often and it requires
> heavy exposure of a circulating amount of the antigen.
>
> There are some important principles of allergy that are really
> necessary to remember. This concept that latex allergy is different in
> some way from other allergies is an hypothesis. Hypotheses are the
> source of progress, but, to be accepted, they have to be proved. There
> is no proof at all that latex allergy is any different than any other
> allergy. It is the same.
>
> There is no proof that tiny exposures to latex cause serious systemic
> reactions. They don\'t. But these are the two hypotheses that are
> being advanced that need to be, if we are to take them seriously,
> established by appropriate prospective controlled experimental
> studies. These studies have not been done.
>
> But other studies have told us three things about this immediate
> allergic reaction that leads to anaphylaxis and other acute reactions.
> That is that the severity of it depends on three variables; how much
> antigen is there, how much antibody the person has. Then another
> variable that is very difficult to measure but is probably even more
> important than the first two is the response of that particular
> individual to the mediators that are released from the mast cells
> after the antigen-antibody combination of the surface of the mast cell
> stimulates it to release these mechanisms.
>
> Now, we do know that the mast-cell histamine release and other
> mediator release is like all biologic responses, dose-related, and
> that it follows the class S-shaped dose-response curve so that if you
> put in a trivial amount of antigen, you get a trivial exposure. If you
> put in a lot of antigen, you get a major response.
>
> Now, this is a slide taken from a paper of John Yunginger published
> back in 1993 when John measured the allergen concentration and the
> protein concentration in a very large number of different rubber
> devices. I have chosen to show you the powered, nonsterile latex-glove
> data because that is the kind of gloves that are probably similar to
> what is used in the food industry.
>
> Now, there are three things I want to bring out on this slide. First
> of all, the measurement of allergen was done by a method devised by
> the FDA, by CBER. It is expressed in terms of allergy units. It is an
> IgE inhibition assay standardized with a latex preparation supplied by
> the FDA called E5. This is calibrated in terms of units. The protein
> was measured by a standard protein assay.
>
> The first point that is important here is that gloves are different.
> These gloves have practically very small amounts of allergen. These
> gloves have a thousand times more. The difference is how the gloves
> were made. It is not really appropriate to say that all gloves are
> alike. What we needed to do at Mayo was get rid of these and buy
> these, which we did, and we thought we solved the problem pretty well.
>
> But to say that we should ban all gloves because there are bad ones is
> just not appropriate. It is a \"one size fits all\" controversy.
>
> The second point is that the concentration of allergen and the
> concentration of protein correlate poorly. In this particular group,
> the correlation coefficient is only 0.3. In some of the other studies,
> it is even worse. Nevertheless, the only practical way, at present,
> for people to try to measure allergen in places that are not research
> laboratories is with the protein measurement. So it is the best we
> have got and it is better than nothing, but it is not exactly the same
> thing as measuring the allergen concentration.
>
> The third point I want to make about this slide is date, 1993, ten
> years ago. The data is out of date. All the data you have been hearing
> is out of date. It goes back to this time before we really understood
> the problem, before manufacturers had changed and gotten more of them
> to do manufacturing processes that provide good gloves, fewer making
> bad gloves.
>
> The Malaysian Rubber Institute has established standards that the
> require all gloves made in Malaysia to conform to. The FDA has been
> considering standards. As a result, as I think you heard yesterday,
> the amount of allergen in gloves has very substantially reduced. They
> are not all bad.
>
> Don, I hope I quote you right from your slide. Did you present this
> yesterday? Okay. Well, you know about the slide. Don wanted to find
> out how much allergen could be transferred from a glove to food and
> set up an appropriately designed study to do so. But, to be sure that
> he had the technique and the range that his assay would detect, he
> picked a glove that was very high in allergen content, on the far end
> of the scale, and, because 80 percent of the antigen is on the inside
> of the glove where the powder is to make it slide on and off better,
> he turned the glove inside-out.
>
> Under those conditions, as I interpret it, about 55 nanograms for each
> time the finger touched the lettuce, there were about 55 nanograms of
> allergen transferred. If we try to put that back into conditions of
> gloves that are probably more on the market these days, and worn
> properly, not inside-out, perhaps the concentration would be of the
> order of nanograms per finger contact. This is this concentration that
> we are talking about.
>
> There are problems still here. Suppose as much as 10 nanograms ended
> up on the food that I ate. After eating a protein, swallowing a
> protein, it hits the stomach where the acid tends to denature it. It
> goes on down into the intestine where the proteases digest the
> protein. Very little protein is eaten every gets into the circulation.
>
> It wasn\'t until I was preparing this talk that it occurred to me that
> what we really need is data on what happens when you eat an antigen.
> We know exactly what happens when you take an aspirin, how much of the
> aspirin is absorbed, where it goes, how it circulates, where it is
> excreted.
>
> The technology exists to do this for antigens, too. It just hasn\'t
> been applied. I should have. I never thought of it. But we don\'t
> know. It certainly is going to be a very small amount and the amount
> that gets to the skin, to the heart, to the lungs, is going to be way
> down at a bottom of that S-shaped curve.
>
> Someone, just a minute ago, brought up the issue of peanut allergy.
> This is an example of the sort of study that should have been done for
> latex and wasn\'t. There is one study which is in the written handout
> I gave you where Dr. Castro challenged six subjects who had latex
> allergy with a solution of latex and saline. He had them drink it.
> Three of the six didn\'t have any reaction at all. The other three had
> what is called the oral allergy syndrome; that is, reaction at the
> site of contact between the allergen and the mucus membrane inside the
> mouth.
>
> One of them was a little hoarse. This is the only really study design
> to try to test this. It tested only six patients. The dose was at the
> low end of the range and only topical symptoms at the site of contact
> were elicited.
>
> There have been several other studies. For example, Dr. Franklin in
> Boston had a patient who had one of these reactions in a restaurant,
> so he took a latex glove, stirred a glass of orange juice with this
> glove. He didn\'t say how, exactly. He didn\'t measure the amount of
> allergen in the glove or in the orange juice, but he did do it
> double-blind and had this patient drink good orange juice and
> glove-stirred orange juice. The patient did have a response after
> drinking the orange juice that was stirred with the glove. This is not
> a glove that touched food. This is a glove that was extracted into
> orange juice and we have no idea what the dose was. But it would have
> been much, much higher than that that we are talking about here.
>
> Here is a study that was done with peanuts. Now, peanut allergy is
> truly a very severe allergy. There are quite a few fatal reactions to
> ingested peanut allergy. Wensing and his colleagues designed a study
> to try to determine what the dose of peanut is that elicits this. This
> is important so that the food industry can know how to ban peanuts
> from other food products.
>
> So he took twenty-six subjects\--not six; twenty-six\--did a
> prospective, double-blind challenge with increased dose of peanut. He
> didn\'t measure the allergen. He measured the total proteins so that
> these numbers are not exactly comparable to the sorts of numbers that
> Dr. Beezhold generates. But at least they are in the range that we can
> understand.
>
> All of these people eventually, with a large dose, developed the
> oral-allergy syndrome at the site of contact in the mouth. They chose
> to call this subjective. It is, but it is a real thing.
>
> There was an objective response, they thought, in six. In three of the
> six, it was really a topical response, again swelling of the lips. Two
> of them had laryngeal edema and one of them with laryngeal edema also
> had vomiting.
>
> The point is that the dose required to elicit this in these very
> sensitive peanut people was of the order of 100 micrograms. Remember,
> with latex, we were talking nanograms. This was micrograms to a gram.
>
> Steve, I hope I am quoting your paper correctly. Dr. Taylor was the
> chairman of the group that looked very carefully into the issue of
> what is the threshold dose of allergen that causes food allergy. They
> picked a group of foods that are known to cause serious allergic
> reactions, particular in children. Fish and peanut persist pretty much
> into adult life as well.
>
> One point here is that the dose of these other foods was about the
> same as it was for the peanut and ranged considerably from around 100
> micrograms to as much as 200 milligrams.
>
> Think about the egg a minute. One of the occupational asthma exposures
> that we have been concerned about is egg processing. People who work
> in the egg-processing industry where they crack eggs, put them in cans
> and sell them to restaurants and bakeries for products, 30 percent of
> those individuals that work in those little plants, mom-and-pop
> plants, mostly, in small communities, 30 percent of those people have
> asthma.
>
> Their asthma is severe, much worse than we were seeing in our patients
> at Mayo. None of those people have trouble from eating eggs, although
> their allergy is to the same protein. They don\'t get asthma when they
> eat eggs. They get asthma when they go to work and breathe it.
>
> The concentration of egg protein in the air was milligrams per cubic
> meter whereas the major concentration we have measured in any of the
> places where we have measured around hospitals, dental offices, place
> like that, is about 1 microgram per cubic meter. That is maximum. Many
> of the concentrations that we encountered were in the nanograms per
> cubic meter.
>
> It is an interesting correlation point. It doesn\'t fit.
>
> I think you saw this, as I flashed through the conclusions. I would be
> happy to answer questions.
>
> DR. DWYER: Would one of the staff get the conclusions up so that
> people can see it. Let\'s get the conclusions up and then we will have
> questions.
>
> Go ahead, Dr. Reed. Do you want to speak to your last slide, just
> summarize what you\--
>
> DR. REED: You have read what my conclusions are. I would be happy to
> answer questions if there are any, or try to answer them anyway.
>
> DR. DWYER: Thank you very much for a good presentation.
>
> **Questions of Clarification**
>
> DR. DWYER: Are there any questions for Dr. Reed? Dr. Hamilton and then
> Dr. Gaspari?
>
> DR. HAMILTON: Thank you, Dr. Reed. Personally, I disagree with your
> third conclusion there, the ban will fuel existing unrealistic fear.
> The reason I do is the experience at Mayo Clinic has been very
> important to all of us. We have seen that you can measure allergen in
> a specialized allergy lab of gloves and you can select gloves for your
> institution and you can reduce the overall levels of allergen that
> people are exposed to.
>
> But 99 percent of the United States can\'t do what Mayo Clinic has
> done. When the individual walks into a restaurant or the people
> working in a restaurant, they have no tools to really measure allergen
> like Mayo Clinic does. So, therefore, extrapolating the experience of
> Mayo Clinic and, to some extent, Johns Hopkins, because we have done
> the same thing, to the rest of the United States is very difficult
> because they just don\'t have the tools to accomplish that.
>
> I have always gone based on the premise that knowledge is strength.
> The problem is, when you walk into a facility and you have no control
> over what people are using in the environment and also with regard to
> food contact, you are basically an innocent bystander that has no
> control. Therefore, you are not in a position to make decisions about
> what you are exposed to.
>
> I think that is where the third conclusion really troubles me a great
> deal. If you walk into an environment and you have no control over
> what you are exposed to, then it is reasonable to expect that an
> individual who has had a systemic reaction may have fear. So fueling
> existing unrealistic fear\--I think \"unrealistic\" is probably the
> word I have the most problem with because I think it is a relative
> term that is very abstract.
>
> So I want you to comment a little bit on how you extrapolate Mayo
> Clinic\'s experience to the rest of the United States.
>
> DR. REED: I think you have raised two issues. One is what is the
> current exposure situation. The current exposure situation is
> different than it was in 1993. We have heard this from other people\'s
> presentations. For example, the Malaysian Rubber Institute requires
> gloves exported out of Malaysia to be labeled as to their protein
> content. All you need to do is look at the label.
>
> So it is clear that it is possible to select gloves that are safe. The
> second point, I think, has to do with a difference of opinion between
> us on interpreting the Hippocratic oath which says that the main job
> of a physician and, in this case, a panel, is to do no harm.
>
> Your interpretation of that is that the best way to do no harm is to
> be sure that there is no exposure. No exposure, no risk. That is a
> perfectly reasonable way of interpreting the situation.
>
> My interpretation of it, though, is different because of the different
> experience we have. We are seeing these people whose problem isn\'t
> really allergy to latex. It is that they are so frightened that they
> might be allergic to latex and have serious reactions that their lives
> are terrible. Telling them that the government has decided that, to
> protect them, we have to ban the use of gloves in making food just
> says, \"Oh, I can\'t eat in restaurants anymore.\"
>
> It is really a different way of looking at it. You have got to have
> seen some of these people and see how seriously they are disabled.
> They are not the kind of cases that are really allergy.
>
> DR. HAMILTON: Certainly, they exist. There is no question. But you are
> not suggesting that all latex allergy is fear and psychological. In no
> way, you are suggesting that; right?
>
> DR. REED: No, not at all. What I am very skeptical of is this report
> that we have heard quite a bit of that people are having serious
> reactions because they eaten in a restaurant where the people wore
> gloves. That just doesn\'t make sense.
>
> DR. HAMILTON: Getting to your first point about us being able to
> select gloves coming from Malaysia that have this total protein level.
> First of all, you have shown very nicely in your data that total
> protein and allergenic content don\'t always agree. I tend to agree
> with that, but more recent data would suggest otherwise, from
> Tomazac\'s group.
>
> But remember that total protein doesn\'t really tell us what the
> allergenic potential of that glove is. Therefore, we really don\'t
> have the tools for the gloves coming out of Malaysia to make decisions
> for the person who is running a restaurant in Oregon, for example.
>
> DR. REED: The only gloves that we have measured that had high protein,
> or that had high\--no; that is not true. The correlation is not as
> good as it ought to be but it is the best we can do.
>
> DR. DWYER: Thank you.
>
> Dr. Gaspari and then who else?
>
> DR. GASPARI: I wanted to make a comment and actually get a response
> from you related to your presentation and the issue you related to the
> absorption of antigen into a dose that could potentially elicit an
> allergic response. You cited an example of 10 milligrams, or 10
> nanograms, of antigen being ingested. The assumption was that the
> amount reaching the blood stream would be too small to be significant.
>
> I am not sure that I agree with that. One comment you made I thought
> related to this issue was important, that we need more information
> about the disposition of allergen, but really what I wanted to
> interject was that when you have an oral exposure to an allergen and,
> again, depending on the degree of sensitivity and the circumstances
> and a lot of points that have been raised, there can be reactions as
> soon as an allergen touches a mucus membrane.
>
> Kind of the discussion you presented in your slide implied that
> nothing could happen until the allergen or antigen reached the blood
> stream. But a lot of things could happen immediately upon contact with
> mucus membrane and it is all related to barrier function and
> transmucosal delivery of antigen.
>
> So a lot of things could happen at very early phases, as soon as an
> allergen touches a highly allergic individual. So can you comment on
> that?
>
> DR. REED: Yes; I would like to refer you to the paper of Dr. Ownby,
> way back in the beginning, about the barium-enema problem. This was
> serious allergic reactions from the allergen absorbed from a rubber
> balloon in the rectum. You are probably familiar with the paper. This
> is one of the two published accounts of a fatal reaction.
>
> The point is that this was a balloon that contained a lot of
> antigen\--we don\'t know how much because it wasn\'t measured\--that
> it was in the rectum where there is no acid, where there are no
> enzymes, and from which we know materials are well-absorbed.
>
> This is not the same thing as taking it by mouth into the stomach and
> upper intestine where it is exposed to digestive enzymes and so on.
> For me to accept the hypothesis that a sufficient amount of antigen to
> cause a systemic reaction is absorbed from nanogram amounts ingested,
> I have got to see data that there is, in fact, absorption. And I
> haven\'t seen that. It doesn\'t exist. Claims exist. We have heard a
> lot of them. They are claims. They are not data.
>
> DR. GASPARI: Clarify, then, what you mean by \"systemic reaction;\"
> meaning anaphylaxis is the way you have defined it?
>
> DR. REED: Anaphylaxis is an extremely severe systemic reaction. I
> would define as a mild systemic reaction the event that I told you
> about, the nurse that we tested excessively who had flushing and some
> hives. That is a systemic reaction.
>
> DR. GASPARI: Perhaps I should just state clearly, my point is that it
> is likely that, in some individuals, with these kinds of doses that
> you are hypothesizing, there is a possibility that there could be an
> early reaction upon contact with mucosal surfaces. I think if we had
> more allergic individuals testifying, I think we would\--again, it may
> be a local and milder reaction, but a reaction can occur at a very
> early stage of contact with an allergen in a highly sensitive
> individual.
>
> DR. REED: The reaction occurs in the mouth where the contact is.
>
> DR. GASPARI: Right.
>
> DR. REED: Let me expand on this a little bit. I have tested a lot of
> hypotheses and, when I retired, I had a file drawer full of hypotheses
> I had proved wrong. One of them was that asthma from rag weed\--we are
> in the middle of the rag-weed season here and I am sure some of you
> are having trouble\--that asthma from rag weed was due to a reflex
> from the reaction in the nose causing bronchoconstriction in the
> chest.
>
> So we tested that and spooned enough rag-weed pollen into the nose to
> account for a whole season\'s exposure. Needless to say, these poor
> people who had a history of asthma during the rag-weed season had very
> severe swelling of the nose and sneezing and were not very happy. But
> we talked them into coming back the next week. This was done in
> January.
>
> We had them inhale this huge dose into their mouth. Again, there was a
> major local reaction. Their uvula swelled up. Their mouth itched. No
> asthma. None. They must have swallowed most of this, too, eventually.
> It is the only way they could get rid of it.
>
> Another week later, we had them come back and we put that same amount
> of pollen into a milliliter of salt solution and had them inhale a
> nebulizer, five breaths, which did cause asthma. From this, we assumed
> that asthma from rag week occurs from breathing small particles in,
> not from the reflex. It was another ten years before we had the
> technology that we could prove, yes, this is true, that late in the
> pollen season, almost half of the pollen allergen that is in the air
> immunochemically measured is not in the pollen. It is in small
> particles that can be inhaled.
>
> So, again, it illustrates the point that allergic reactions occur
> where the allergen is and that, for it to occur in the lung from
> airborne allergens, it has got to get into the lung. For it to occur
> in the skin, it has got to get into the skin. For it to affect the
> heart, it has got to get to the heart. And, if this is going to be a
> severe reaction, there has to be a lot of antigen.
>
> The situation we are talking about here just doesn\'t deliver that
> kind of antigen. A bad balloon in the rectum does. An injection during
> a surgical procedure does. Eating a sandwich made by somebody who wore
> rubber gloves doesn\'t.
>
> DR. GASPARI: If I could interject one last comment. I guess your
> pollen work sounds elegant. Again, pollen allergens are not vulcanized
> and heated and degraded into small polypeptides the way NRL
> polypeptides are. Secondly, if you have a significant enough local
> reaction in the oral mucosa and upper airway and the laryngeal edema,
> that could pose a life-threatening situation even though it is a
> localized\--in other words, if you compromise the airway from a local
> allergic response, that potentially could be life-threatening even
> though it is not necessarily anaphylaxis, if you acutely
> compromise\--all the medical personnel here know this very well.
>
> DR. REED: But, again, the amount of antigen it took to do that with
> the peanut exposure was in micrograms.
>
> DR. DWYER: I must say, Dr. Reed, that people in Minnesota will do
> anything to keep busy during the winter, won\'t they?
>
> Dr. Taylor has a more substantive remark, I think.
>
> DR. TAYLOR: I think this idea of trying to figure out what the lowest
> eliciting dose is for natural rubber latex allergens is very important
> and we could sit and conjecture and provide our opinions, professional
> opinions, all day long. Dr. Reed is absolutely right that there is
> almost no data on the lowest eliciting doses of allergenic substances
> taken by mouth.
>
> I happened to sponsor the research done by Wensing\'s group in The
> Netherlands. I just wanted to make the comment that it is quite sad
> that there is no governmental funding anywhere in the world to sponsor
> this kind of research. But yet governmental agencies convene
> committees to come up with learned decisions about lowest eliciting
> doses when there is no scientific or clinical information on it.
>
> This very important piece of information, I agree with you completely,
> could be developed and determined. I would agree that we also don\'t
> know how much allergen might actually get absorbed through the oral
> mucosa if you just held it in the mouth. When you looked at that
> peanut study, there were a lot of reactions that were significant
> reactions but localized. Laryngeal edema, lip swelling; those were the
> first objective reactions that occurred in those highly sensitive
> subjects on oral exposure.
>
> I would anticipate seeing the same thing in latex-allergic individuals
> if they were sensitive by the oral route at some dose. I just don\'t
> know what the dose is. There is an absence of information here but I
> am glad he brought up the peanut study because I think those kinds of
> studies, if you assume that latex and peanut are equivalent\--that
> might be a poor assumption, but at least it would be something to go
> from on a dose-response basis.
>
> DR. REED: For example, Bob, peanut antigen has been\--there is
> recombinant peanut antigen, the assays would be precise. It could be
> done the way you would like to see it done. The same thing is true of
> latex. We have perfectly fine reagents, assays, to do these studies.
> They just need to be done.
>
> DR. HAMILTON: May I comment?
>
> DR. DWYER: Yes.
>
> DR. HAMILTON: We have approached our IRB to try and do some of these
> types of challenge studies. There has been a tremendous amount of
> resistance to permitting us to actually do these studies. Maybe
> possibly in the olden days, they were less restrictive. But, today, it
> is becoming more difficult.
>
> DR. REED: If I were going to design the study, I wouldn\'t pick
> allergic people to do it in. I would do it in normal people. I would
> do a phase I in terms of FDA terminology.
>
> DR. DWYER: I think what you need to do is go to Minnesota in the
> winter. Maryland is much nicer in the winter.
>
> Dr. Reed, I had a couple of questions and I am sure some others have a
> few more before we send you back to Northern Wisconsin. The first is I
> think you have made a point that has troubled me for a day now, that
> the level of evidence is not very impressive. There are case studies
> and there are a whole bunch of other experiments that we would love to
> see.
>
> One thing is why is it that these tests that are used don\'t include
> all the allergenic proteins. I don\'t know if you were here yesterday,
> but they talked about a couple of test kits that didn\'t really have
> all of the various things that are now thought to be allergens. Why is
> it that placebo, some of the more elaborate designs that could
> eliminate placebo effects are not used.
>
> It would seem to me that these are state-of-the-art now and yet we are
> looking at a bunch of case reports. Why is it that the industry or
> universities or somebody hasn\'t really done these studies?
>
> DR. REED: I can\'t really answer either of those questions. They
> haven\'t been done. Bob and I have had a lot of conversations about
> trying to develop a more reliable assay for these antigens. The
> problem there is organizational and money. It would take a large
> multicenter cooperation between people in several places in the United
> States, several places in Europe, Germany, Finland, Italy, Spain, to
> do these.
>
> I am retired. Bob\'s busy. Neither one of us has any money. It just
> isn\'t getting done and I can\'t tell you why. But it needs to be
> done. We have measured the amount of antigen inhaled into the lung and
> recoverable from bronchoalveolar lavage. That has been done. There is
> no reason we couldn\'t just get a blood sample and measure the amount
> of antigen in the blood. It is easy. Nothing to it.
>
> DR. DWYER: Thank you. That is very enlightening. The other question
> has to do with food lists. I am a nutritionist and I understand why
> our previous speaker found the list very confusing and difficult to
> find some rationale. I assume the rationale is something to do with
> the botanical, the Linnean, classification of different plants and
> what they can produce, but what is the rationale behind these lists?
>
> DR. REED: The cross-reactions between latex and other foods?
>
> DR. DWYER: Yes; and are some of those\--in other words, is a potato
> more lethal than an avocado.
>
> DR. REED: This is not one of my areas of particular expertise, but I
> understand that these allergens, proteins, have functions for the
> plant. They are not just sitting around there waiting to cause us
> trouble. They are being synthesized by the plant for the purpose of
> the plant.
>
> Many of them are protective things, to protect the plant from fungal
> infections, insect degradation, and so on. Others have to do with, in
> the case of latex, coagulation. There are the coagulation proteins.
> But these processes in plants are widely conserved across the plant
> kingdom. So it is not surprising that rubber sap and rag-weed pollen
> have similar epitopes. They do.
>
> They are more common, perhaps, in some of the foods like kiwi and
> banana and avocado, but they are really very widely distributed across
> the plant kingdom. It is interesting that these people aren\'t seeming
> to have too much trouble from the foods. Occasionally, they do, but,
> again, it is a big dose from a food compared to what would be
> transferred from a rubber glove to a piece of lettuce.
>
> DR. DWYER: Fair enough. Thank you.
>
> Any other questions? One more.
>
> DR. JOHNSON: At the end, your implication was that the conclusion from
> these case reports that the latex-allergic consumers were having
> allergic reactions when they consumed food that had been in contact
> with the latex gloves was simply nonsensical. So I am wondering if you
> have an alternative explanation for the reactions that these people
> experienced.
>
> DR. REED: I suspect most of them are coincidence. For example, there
> is a syndrome called idiopathic anaphylaxis. When I see these
> patients, I define the word \"idiopathic\" to mean that the doctor is
> an idiot and the patient is pathetic. But really it means unknown.
> People have anaphylaxis that are not allergic to anything. This may be
> the case with a few of these people.
>
> They may have eaten something that had the allergen in a food in large
> amounts that we don\'t know. It may have been pure coincidence. In
> some of these people, the problem is anxiety.
>
> One of the difficulties in diagnosing anaphylaxis is that many of the
> symptoms are similar to an anxiety attach; the shortness of breath,
> the wheezing, and so on. It is a difficult issue and I think that
> everybody is different. Each of these people has got some other
> reason, but my point is that, in none of these cases has there been
> confirmation that the exposure was the result of somebody touching the
> food they ate with a high allergen content block. That is just not
> there.
>
> DR. DWYER: Any other questions? Thank you very much.
>
> At this juncture, I think we are going to take a sort break. After we
> come back, we have one additional change on the program. Dr. Hepp is
> going to come back and try to answer some of the questions we posed
> yesterday to FDA. We asked several things over the course of the day
> yesterday and he will try to address those.
>
> I also bring to your attention a number of handouts that the committee
> has received; Dr. Reed\'s testimony, a statement from the Final Rule
> by the department and Federal Register notices. What else do we have
> here? Something else from NIOSH. So we have got a bunch of materials
> here for our perusal and discussion later on in the day.
>
> So, coffee break, and we will be back in ten minutes.
>
> \[Recess.\]
>
> DR. DWYER: Dr. Hamilton has pointed out that there seems to be some
> confusion about a couple of points on antigens and so forth for some
> of the people who are not immunologists. He has agreed to just give us
> a little sort of two-minute tutorial on this and perhaps some of the
> rest of you who are experts on this would also like to comment, while
> we are waiting.
>
> Rich, would you let me know when you are finished with your
> arrangements and then we will go into the next presentation.
>
> DR. HAMILTON: There has been a lot of discussion of total protein
> antigen and allergen. I thought it might be useful, because I was
> expecting Dr. Tomazac from the FDA to actually overview the whole
> issue of how this history evolved.
>
> I will try, in just a few minutes, to give you a gestalt of this whole
> thing.
>
> DR. DOWNER: If I could interrupt you for one second.
>
> DR. HAMILTON: Please.
>
> DR. DOWNER: Goulda Downer. You keep using \"gestalt.\" I suspect it is
> a foreign word. What do you mean?
>
> DR. HAMILTON: Gestalt. My feeling. I\'m sorry; please forgive me.
>
> DR. DOWNER: The origin of the word is\--
>
> DR. HAMILTON: It is a German word. I\'m sorry.
>
> DR. DOWNER: It means \"the whole?\" Okay. Thank you.
>
> DR. HAMILTON: Thank you.
>
> DR. DWYER: It is because he is from Baltimore. He uses funny words. It
> is where Mencken came from.
>
> DR. HAMILTON: In 1992, when the FDA held its first international
> symposium on latex allergy in Baltimore\--and they held it in
> Baltimore because the FDA government employees could get paid per diem
> in Baltimore but not in Washington, D.C. So they moved it all up to
> Baltimore, not because Baltimore is special.
>
> We had, at that time, a lack of knowledge about what latex contained
> in terms of allergenic materials. We knew that there were several
> components, but we didn\'t know a lot. There were a variety of
> immunologic techniques that were applied using human IgE
> antibody-containing sera from patients that were characterized as
> latex allergic.
>
> The very first assay that was picked up and done was a total protein
> assay on the extracts or the natural rubber latex material coming out
> of the trees. That was the assay that moved toward the ASTM, the
> American Association of Testing Materials, and was developed as a
> reference method or a standard, so to speak, and it was the Lowry,
> which is a very classic total protein assay.
>
> It was modified to precipitate the protein because the protein was
> actually interfering\--I mean, the precipitate, the chemicals in the
> extracts, because they were interfering in the Lowry reaction. So the
> modified Lowry, which involves a precipitation of the chemicals prior
> to total patient assessment as a colormetric assay was the initial
> assay that was used.
>
> Extracts of gloves and also the material that was referred to by Dr.
> Reed, this material from the FDA, this E8\--it initially E5 and then
> it was E8\--is a natural rubber latex, crude latex, which is been
> lyophilized and put in a bottle, or it is actually in a bottle and it
> is supplied to everyone. All of us use E8 as a reference material for
> our allergen assays.
>
> Then, historically, a group, a variety of groups\--Dr. Beezhold was
> one of them\--developed rabbit antisera that detected the proteins in
> the latex and set up a variety of assays for measuring antigen.
> Antigen is a protein that elicits an immune response but is not
> necessarily IgE-antibody-inducing. So some of the antigens are
> allergens but not all of them.
>
> That was the second assay that the group went to the ASTM and actually
> proposed a standard and, in fact, worked on developing an enzyme
> immunoassay called an ELISA, Enzyme Linked Immunosorbant Assay,
> inhibition assay, where they take the extract and put it in with the
> rabbit antiserum and react it, and then they take that mixture and put
> it into a microtiter plate well that has solid-phase antigen. They do
> a competitive inhibition.
>
> So, if there is antigen in the extract, it binds to the antibody and
> it prevents it from binding to the solid-phase antigen. It is
> competitive inhibition. I can\'t explain it quickly but I will do
> better if you are interested later.
>
> That assay has been used in a variety of different settings and it has
> the limitation that it detects proteins that are not allergenic. So,
> when we see total protein and then we see a subset of that which is
> antigenic protein, then we have to look at the subset of a antigenic
> protein that elicits IgE antibody and that is allergenic protein.
>
> In the past several years, the Finnish group, in particular, has come
> out with four assays. We now know that at least there are thirteen
> allergenic components that have been cloned and sequenced, Hev b 1
> through Hev b 13. Dr. Slater very nicely gave us an overview of all of
> those.
>
> The question about how these fit into various categories based on
> plants, there is a fellow from Austria, Breiteneder, who actually has
> very nicely categorized these in terms of their biological functions
> and shows how the cross-reactivity actually has relevance based on
> their plant characteristics, upon their biological properties,
> basically. Some are chitins.
>
> DR. DWYER: Where is that published?
>
> DR. HAMILTON: It is published in the Journal of Allergy and Clinical
> Immunology. In fact, there are a couple of very excellent overviews of
> this. They are actually reviews on this topic. So this is an area that
> has been well examined, at least been nicely presented. The Academy of
> Allergy gave a wonderful presentation.
>
> The Finnish, in particular, developed what they call a two-site
> immunoenzymetric assay. It is a monoclonal antibody that binds to
> allergenic protein that they put in solid phase. Then they came back
> in with a second antibody that binds to another determinant on the
> allergen. So, two-site, immunoenzymetric assay for allergenic
> components.
>
> They have a commercial product for Hev b 1, 3, 5 and 6.
>
> The FDA group, Dr. Tomazac, which I expected her to speak on this
> issue but she didn\'t maybe because it is in the process of being
> published right now, got together a working group primarily from the
> ASTM but all the laboratories throughout the world that have knowledge
> of these assays.
>
> I might digress for a second and say there has been, since 1992, an
> assay for measuring allergenic potency of extracts using human
> IgE-containing sera. It is called the RAST inhibition assay. That is
> the assay that the FDA uses to assess potency of crude extracts.
>
> That RAST inhibition assay is done, at least to the best of my
> knowledge, in the United States in probably three or four research
> laboratories but not in clinical laboratories in general. It is a
> research assay. But it has been calibrated using the E8 based on total
> protein, not based on allergenic components in that E8.
>
> So Dr. Tomazac got together this group of about eight labs across the
> world and she made thirty extracts from a cross section of gloves
> collected from across the world. These extracts were frozen. They were
> sent to all the laboratories and these various methods, the total
> protein, modified Lowry, the antigen assays using rabbit antisera, the
> RAST inhibition assay or nonisotopic component, and then the two-sided
> immunoenzymetric assays for the individual allergens, Hev b 1, 3, 5
> and 6 were all run on the same extracts.
>
> Those data are available and they are being summarized right now for
> publication. They tell us a great deal of the performance of these
> assays and all I can suggest, as a conclusion, is that have now moved
> from measuring total protein, which is very crude, through antigen to
> now having assays that measure four of the primary allergenic
> components.
>
> There is a group in Malaysia, the Rubber Research Institute of
> Malaysia, and also the Thais, the Germans, Australians and a few of us
> in the United States that are all developing monoclonal antibodies for
> the other allergenic components so we can have an assay to measure
> each one of the thirteen allergenic components separately.
>
> The question is how do we design a simple assay for the manufacturer
> at the site so they have one assay that measures total allergenic
> potency when, right now, we have thirteen individual assays that we
> have to really set up.
>
> DR. DWYER: That was great. Thank you. I wish you had taught me
> immunology instead of the person who did.
>
> I think we are back to serious stuff and I guess it is going to be
> you, Dr. Hepp.
>
> DR. HEPP: Good morning. I am the one that is responsible for the
> little package that was left at your place today that has a paper clip
> on it. Yesterday, you agreed to use the definitions that ASTM
> developed for terms, natural rubber, natural rubber latex, things like
> that.
>
> My understanding from Dr. Stratmeyer is that those terms that they use
> in their final rule of labeling were the ASTM definitions. The top
> page on that little handout with the paper clip has those definitions.
> I think, because there was some confusion over what those terms mean
> yesterday, I think it might be worth going into a little bit right now
> just to make sure that everybody is on the same page about what these
> things mean.
>
> In general, a latex is a suspension of small, solid particles in an
> aqueous phase. It is not necessarily a natural rubber latex. Latex
> house paint, for instance, is a suspension of acrylic polymer in
> water. There is no natural rubber in that at all.
>
> A natural rubber latex is obtained by tapping the bark of the natural
> rubber tree. It is the suspension of cis-1-4 polyisoprene in an
> aqueous fluid that contains the most things that are produced
> naturally by the plant. This milky fluid that is a latex obviously is
> not the material that the gloves are made out of.
>
> Latex gloves are natural rubber. In the production of latex gloves,
> they take molds, they dip them into this milky fluid so that the molds
> have a coating of the latex. The molds are then moved into an oven
> where they are heated, the water is driven off and the polymer that is
> left on the mold cross-links.
>
> Once the water is driven off, we no longer have a latex. The only
> things left were the solids that were suspended in the latex. Medical
> gloves and food-service gloves are often called latex gloves, but they
> are made out of natural rubber through a latex process, a dipping
> process.
>
> Not all natural rubber products are made through a dipping process
> using latex. Some are compounded from sheets of dry rubber. The
> dry-rubber process tends to have a lot less available protein, a lot
> less extractable protein, I should say.
>
> So latex gloves are something of a misnomer in that they are really
> natural rubber gloves. Latex allergy, likewise, is somewhat of a
> misnomer in that it is really an allergy to proteins in natural
> rubber.
>
> Which brings me to the next point which was yesterday there were a lot
> of questions about what is the difference between medical gloves and
> food-service gloves. Medical gloves, medical devices, are regulated by
> the Center for Devices and Radiological Health. Each individual device
> is an individual product and they have regulatory authority over those
> products.
>
> So they set specifications on gloves because gloves are medical
> devices. It is important to realize that there is a difference in how
> CDRH regulates things and the way the Center for Foods regulates
> things. The Center for Foods regulates substances that may migrate the
> food as a result of their contact with food. We regulate food-contact
> substances but we don\'t regulate the products. We regulate the
> chemicals that may be used to produce those products.
>
> The second page in the handout that I gave you is a copy of Title 21
> of the Code of Federal Regulations 177.2600. It is our Repeat Use
> Rubber Article Regulation. This regulation provides, among other
> things, a list of chemicals that can be used in the production of
> repeat-use rubber articles. So, basically, the Center for Foods
> regulates food additives based upon a generalized intended use. The
> generalized intended use here is repeat-use rubber articles.
>
> So you will see on the second page of that regulation I highlighted in
> green for all of you, the listing for natural rubber. So there isn\'t
> a regulation that defines food-service gloves. There is a regulation
> that lists all the chemicals that can be used to produce any kind of
> rubber article that can be used to contact food. As long as your
> rubber article complies with that regulation, it is permitted to be
> used in contact with food.
>
> So, there isn\'t a regulation stipulating specifications for
> food-service gloves.
>
> DR. DWYER: But I am reminded of the Supreme Court Justice who said he
> knew pornography when he saw it. How do I know when something is a
> food-service glove versus a medical glove in the world outside the
> Food and Drug and Cosmetic Act?
>
> DR. HEPP: The gloves that are used in food service are required to
> comply with the regulation which means that they are formulated based
> upon the materials in that regulation and they meet the specifications
> at the end of that regulation are extractive limitations, so that the
> final food-contact article must meet those extractive limitations.
>
> Manufacturers, when they sell to the food-service industry\--rather,
> when food-service managers order food-service gloves, they inform the
> manufacturer that these gloves are going to be used in contact with
> food and that they need to comply with this regulation. The
> manufacturers then supply gloves that comply with this regulation.
>
> Now, compliance with this regulation doesn\'t necessarily mean that it
> meets all the standards in the device world. A lot of those standards
> relate to efficacy and we don\'t have efficacy requirements. So gloves
> that don\'t necessarily meet the standard in a medical setting are not
> necessarily substandard in the food setting.
>
> DR. DWYER: So, as I understand it, there is a hierarchy of criteria
> and it starts with the medical glove. Then there is the food-service
> glove. Then there is the garden glove, or the garbage glove or some
> glove that is used for cutting down trees or something like that.
>
> DR. HEPP: I would say that there are many different glove
> manufacturers. Many glove manufacturers produce gloves for the medical
> market. For those manufacturers, they have lines that are set up to
> meet the medical-glove specifications. When they market gloves to
> consumer markets or the food-service market, chances are real good
> that they don\'t have a separate lower-quality line to produce their
> gloves. It is just easy to pull them off the same line.
>
> There are other companies that produce gloves only for the consumer
> market and don\'t attempt to meet the medical standards. Those gloves
> may have various levels of standards, but if they sell them to the
> food-service industry, they have to, at the very minimum, meet the
> criteria in 177.2600.
>
> However, 177.2600, as we noted before, is a regulation that was
> promulgated before the issue of latex allergy became known. Basically,
> the safety studies involve looking at the toxicity, the chemical
> toxicity, of the chemicals that might be expected to migrate from the
> gloves. The allergy issue wasn\'t considered.
>
> DR. DWYER: Thank you.
>
> DR. HEPP: Also included in the package, after the regulation, is a
> copy of the\--the committee asked yesterday for FDA to provide a copy
> of the NIOSH Technical Information Bulletin. Page 7 of that technical
> information bulletin contains the recommendations that Dr. Beezhold
> read to us yesterday.
>
> It is important to realize that the recommendations, the OSHA
> recommendations and the NIOSH recommendations and the American Academy
> of Allergy, Asthma and Immunology recommendations are all developed
> based upon the use of rubber gloves as a personal protective device,
> generally as a personal protective device, for the worker.
>
> The decision to make such recommendations comes easy to occupational
> safety personnel because the risk of certain\--well, if the gloves are
> intended to be used as a barrier to exposure to bloodborne pathogens
> and you are balancing that risk against the possibility contracting a
> latex allergy, it becomes obvious that food-service workers and
> gardeners and housekeepers are not encountering bloodborne pathogens.
>
> So the almost nonexistent risk that they are going to encounter a
> bloodborne pathogen does not outweigh the risk that they are may have
> issues with latex allergy. So that is the context for those
> recommendations about food-service workers.
>
> However, the other thing that is important to cover here is why FDA
> recommends that food-service workers wear gloves. Food-service workers
> wear gloves to transmission of pathogens from the hands of the workers
> to the food which is then consumed by people who buy the food.
>
> Your background papers\--there was basically a one-paragraph
> description of how we arrived at the no-bare-hands contact rule which
> is not a rule or a recommendation that requires the use of gloves. But
> it is easily noted that many-tasks gloves are the preferred implement.
>
> In that background document, it states that, \"Research has shown
> that, when food-service workers\' hands are contaminated with
> foodborne pathogens via the fecal-oral route, hand washing alone is
> not always sufficient to transmit of those pathogens to food.\" So, it
> is important to acknowledge that FDA doesn\'t recommend the use of
> gloves in place of handwashing, but we expect that washed hands are
> put into those gloves and the gloves are intended to prevent the
> transfer of pathogens to food.
>
> DR. DWYER: That is very helpful.
>
> DR. HEPP: I guess the last thing was that you asked for a presentation
> that we didn\'t have slides for, or we didn\'t have handouts for
> yesterday. That is the last thing in the package.
>
> DR. DWYER: Wonderful.
>
> Dr. Hamilton had a question.
>
> DR. HAMILTON: I would just like to go back to one previous question
> that we had which, in reading this 177.2600, it looks to me like there
> is no actual specific designation as glove but more rubber products,
> or rubber articles. Therefore, again, this really refers to all rubber
> articles that come in contact with foods; is that\--
>
> DR. HEPP: This refers to natural rubber, whether it is a
> natural-rubber article that has been made from a latex process or from
> a dry-rubber process, whether it is a natural rubber that is used to
> make a conveyor belt or a glove. Any article that is used in contact
> with food and it is used repeatedly in contact with food is subject to
> complying with this regulation.
>
> DR. HAMILTON: So rubber in an adhesive, in a package that comes in
> contact with my cornflakes, is also included in this?
>
> DR. HEPP: That wouldn\'t be a repeat-use article.
>
> DR. HAMILTON: It is not a repeat use?
>
> DR. HEPP: Packaging is not a repeat-use article.
>
> DR. HAMILTON: You use it once.
>
> DR. HEPP: If it is used to package one food\--it can be confusing
> because the package you use repeatedly. You, the user, use\--you
> don\'t eat the whole box of cereal at once. But the food that is being
> packaged in it contacts that material only once. For food-additive
> approvals, it is not the user\'s perspective that is important.
> Rather, it is how often foods, or how many different types of foods,
> contact that material.
>
> DR. DWYER: Dr. Gaspari had a question, Dr. Hepp.
>
> DR. GASPARI: I wonder why the FDA hasn\'t commented on the use of
> other glove materials as a potential barrier, vinyl gloves or nitrile
> gloves, as an alternative to a barrier. I guess a related question is
> any microbiologic evidence as to the claim that it prevents fecal-oral
> transmission into the food via the hands, either with NRL gloves or
> any other kinds of gloves. There has got to be work on that that is
> based on science.
>
> DR. HEPP: We have commented on the use of alternatives at this meeting
> and that is to say that the barrier properties or the effectiveness or
> the safety of alternative materials will not inform us about the
> safety of latex.
>
> DR. DWYER: We are just to consider the safety of latex.
>
> DR. HEPP: Under our regulations, we don\'t do\--under Section 409 of
> the Federal Food, Drug and Cosmetic Act, we review the safety of a
> food-additive use of a certain chemical and a regulation is
> promulgated based on the safety of its use, not based on whether it
> may be more or less safe than an alternative material.
>
> So discussing issues relating to alternative materials won\'t really
> inform us as to whether latex is safe.
>
> DR. DWYER: We have to go back to this sheet to get the specific
> questions they are asking. It is not always all of the most
> interesting questions scientifically. It is rather specific to the
> regulations. But that was a good point to bring out.
>
> DR. HEPP: Your second question was the evidence, the microbiological
> evidence, that hand-washing alone may not be enough to prevent the
> transmission of foodborne pathogens from workers\' hands to the food,
> in your background paper, Reference 28, lists a number of references
> that go directly to that point.
>
> DR. DWYER: Is it possible to get a copy before this afternoon in our
> deliberations of the Breiteneder paper in Journal of Allergy and
> Clinical Immunology that Dr. Hamilton mentioned?
>
> DR. HEPP: That is the Canadian Journal of Allergy and Immunology?
>
> DR. TAYLOR: No; it is the Journal of Allergy and Clinical Immunology.
> I think it is like January 2002. It is Heimel Breiteneder. I always
> call him Heimel. His first name is Heimel. His first name is way
> easier to pronounce than his last. It talks about pathogenesis-related
> proteins which tend to be allergens. There is PR1 through 15 or
> something like that. These tend to be allergens that, because they are
> pathogenesis-related proteins, they exist in a lot of different foods.
>
> DR. DWYER: We have two people on the committee who are fairly familiar
> with the paper, but others may want to take a look at it. Great.
>
> Any other comments? Dr. Taylor has a question for you, Dr. Hepp.
>
> DR. TAYLOR: We have heard a couple of comments that some of the
> proteins in natural rubber latex are hydrolyzed or degraded. I am
> confused about that. Are these proteins intact or are they somehow
> modified. If I extracted a protein from a glove, would I find the same
> proteins that I would find in the sap taken out of the tree, I guess
> is my question.
>
> DR. HEPP: I think you might find both; that is, when the latex is
> tapped from the tree, it usually drips into a small cup that contains
> an ammonia solution. That ammonia solution keeps the latex from
> coagulating and becomes just a solid lump.
>
> The ammonia solution tends to hydrolyze the proteins. It won\'t
> hydrolyze the proteins completely and the longer it spends in the
> ammonia solution\--it is a rather slow hydrolysis, but it does happen.
>
> DR. DWYER: Are we all set? Any other questions for Dr. Hepp?
>
> Thank you so much for being so responsive, Dr. Hepp. Thank you to all
> the staff for accommodating our questions and doing so well to answer
> them with data.
>
> We will turn now back to the program. We are up to invited comment
> from the retail food provider. John Schulz who is V.P. of Food Safety
> from the Marriott Corporation is going to give us his insights.
>
> Mr. Schulz, thank you for coming. The floor is yours.
>
> **Invited Comment from a Retail Food Provider**
>
> MR. SCHULZ: Good morning, everyone. First and foremost, as a
> food-service industry professional, I want to say that we are all
> looking forward to these hearings as well as in the future, a clear
> decision on what we, as users of gloves within our industry, should do
> so that we can provide a safe environment not only for our associates
> but as well as our guests.
>
> Since the founding of the Marriott organization in 1927, we have
> always been concerned about the genuine comfort and safety of our
> guests. When I joined the organization in 1987 as an executive chef,
> every time I put a plate of food down in front of our guests, I had
> the utmost concern not only that the food was going to taste good but
> that I was not going to be passing on an allergen or any other type of
> food danger to that consumer.
>
> My reputation as well as the reputation of our company was always at
> stake. I am definitely not a scientist so if you have very scientific
> questions, I probably cannot answer those for you today. But what I am
> going to answer for you is my perspective from an industry person on
> the use of gloves as well as where the risks might be.
>
> Obviously, in my current position as Director of Quality Assurance for
> Marriott, I am responsible for the safety of our guests while they
> stay within our hotels on a day-to-day basis and, more specifically,
> the food. We base our decisions not only on, again, the safety of our
> guests but we also have to take the risk into consideration. The
> greatness of that risk does drive how we make our decisions.
>
> You need to understand that Marriott is a company that operates in
> over 56 countries worldwide. We have restaurants in hotels in all of
> our hotels in many different countries. We do our best to specify a
> type of glove that we should use, but understand that, in a company of
> our size, there is definitely the use of what we specify as well as
> gloves that probably aren\'t to our exact standards being used.
>
> We have been using latex or natural rubber gloves within our company
> for the past thirteen years. We use them extensively. We use them
> where they need to be used and we use other things within our
> facilities to limit the use of the gloves.
>
> We use them for obvious reasons I am sure you have heard in the past
> couple of days, but we use them so that we do not pass on to our
> guests pathogenic organisms, specifically things like Staphylococcus
> aureus and Hepatitis A. Again, it is one of our major concerns that we
> do not get involved in a foodborne-illness outbreak and would even be
> brought into the arena of foodborne-illness outbreaks because of the
> liability at stake.
>
> So we take this very, very seriously. What we have seen is we have
> seen a significantly low incident rate of any types of these two
> illnesses within our company the past two years, and to give you a
> couple of examples. In the past ten years, of all of our operating, or
> all of the meals that we have served, we have only had one confirmed
> case of Hepatitis A that has been transmitted from one of our
> associates to our guests. Staphylococcus aureus is the same. It has
> been one case that we have seen transmitted from one of our associates
> to our guests.
>
> Now, whether our record-keeping is absolutely perfect, I cannot
> guarantee that. But I am responsible for overseeing when there is a
> situation where either an associate or a guest has a reaction or is
> made ill by our foods. In running that for the past ten years, we have
> had only two cases in this area.
>
> We have had less than five documented incidences of Hepatitis A and
> two incidences of Staph transmission to a guest over the past year, so
> it has been very, very minimal.
>
> What is our glove policy? We only wear gloves, which was already
> mentioned, over adequately washed hands. What we mean by adequately
> washed is that we wash them for twenty seconds according to the FDA
> requirements. We use an antimicrobial soap. We wash them as often as
> necessary.
>
> We also use them when touching any ready-to-eat foods with our hands.
> So, if we have to make a salad or toss a salad with our hands or if we
> have to place a small garnish onto a plate, we utilize gloves to do
> that, again, obviously, so that we don\'t transmit the organism.
>
> We do have specific requirements for our gloves and we only require
> the use of examination-quality latex and vinyl gloves. We label that
> clearly on the box. It has to be labeled that way so I would consider
> these medical-grade gloves as well.
>
> We do test for specific things in our gloves and we manage that
> through testing for soluble proteins. We take thickness tests as well
> as strength tests. We manage the physical integrity of the product. We
> also test for specific microorganisms on the gloves as they are being
> produced so that we can manage it from that perspective as well.
>
> We do not wear gloves when handling raw foods, meaning if we are
> putting raw chicken onto a grill, we are not going to put a glove
> there. We will use a utensil or some other barrier in place. We wash
> our equipment as much as possible to eliminate the amount of bacteria
> around the facility so we manage it also from that perspective so that
> we don\'t have the ability for someone to cross-contaminate from a
> contaminated surface or product onto a ready-to-eat food product.
> Again, as I said, we use gloves when we touch any type of ready-to-eat
> foods.
>
> We really try to limit the use of gloves because I am sure we have
> heard the argument on both sides of the aisle here. We have heard that
> you should just wash your hands more and more and more and you don\'t
> need to use gloves or then there is the side that says, no, gloves
> does have a practical approach within our industry. I would suggest
> that it is the latter.
>
> I will add that I am not here today to say whether we should use latex
> gloves or not use latex gloves within our industry. We follow the
> recommendations of the FDA and people like you who give us the
> scientific evidence to go the right direction to protect the consumer.
>
> Understand that gloves are not a substitute for washed hands. It is
> obvious that you have to have a diligent hand-washing program in
> place. You have got to constantly train your associates to do that and
> then to use gloves where appropriate. It is not a perfect science. It
> is impossible to regulate\--I have heard comments regarding, well, how
> can you guarantee someone is not going to use a latex glove versus a
> vinyl when someone says they have a latex allergy. You can\'t manage
> it that closely. It is very impossible in our industry.
>
> We use gloves when performing in high-risk transmission areas. So if
> we are doing a catering event for 5,000 people, we want our people
> wearing gloves because the potential for making a lot of people sick
> is there. So, again, it has a significant impact when you are dealing
> with large volumes of people.
>
> We also do it where, again, if a customer comes in and tells us they
> have a latex allergy, we use vinyl gloves in that predicament.
> Honestly, as an executive chef, I prefer to not use of gloves anyway
> because it does impact the tactile ability of your hands to do nice
> food. So that is also in the argument. We minimize, again, the usage
> as much as possible.
>
> Here are some of the assumptions that we have made. We have a minimum
> concern raised by our associates regarding allergenic reactions from
> their use. Our chefs are very close to their people and I talk to our
> chefs on an ongoing basis. They call me very, very frequently and I
> have never heard of any cases other than sometimes a minor rash
> reaction or hives from an associate wearing latex gloves within our
> facilities. Again, we use millions of them.
>
> Again, we look at an examination-quality glove as having significantly
> lower protein content which has been linked to the allergenic reaction
> from their use. We manage the protein levels which we feel is what is
> impacting our low rate of reaction to the gloves.
>
> We, again, manage the thickness and elasticity and resilience of the
> product because, obviously, if you get a latex glove or a piece of
> latex glove into the food, the ability for someone to react it would
> be much greater, so we do manage, as well, a integrity of the gloves
> that we use. Using an examination-quality glove, we have found to have
> a much lower number of pinholes or breakage occurring during their
> use.
>
> Our ultimate goal is to provide a consistent product, not only in a
> product type but in a specification that we can use worldwide that we
> can have manufactured by a variety of different people if necessary.
> The thing to take into consideration is it is not the latex glove that
> you use; it is quality of the latex glove that you used.
>
> If you have latex from poor manufacturers, what we have found is very
> high protein contents which, again, what we are basing our information
> on is that that is what is driving the allergenic reaction for both
> our guests and our associates.
>
> I can only tell you the figures. We have not had any major problems
> over thirteen years. We use extensively latex and vinyl gloves within
> our organization and those are just the bare facts. So how the
> decision goes, whether it is very scientifically based or whatever, in
> our organization, we continue to promote the use of both latex and
> vinyl gloves as a deterrent as well as to protect our associates from
> allergenic reactions as well.
>
> With that, I would like to close out. If there are any questions?
>
> DR. DWYER: Thank you. That was very interesting.
>
> **Questions of Clarification**
>
> DR. DWYER: Can I just start by asking why don\'t you use all-vinyl
> gloves?
>
> MR. SCHULZ: I have to say that probably part of it may be based on
> cost. Again, we use extensive numbers of these. We started with latex
> in the beginning, I guess is another reason. We have just never had a
> problem and we have continued to use a high-grade product. The chefs
> like latex gloves versus vinyl because of their ability to give them
> tactile ability when they are place garnishments and doing the
> culinary stuff that we do.
>
> DR. DWYER: Very good.
>
> Dr. Scholz and then Dr. Gaspari.
>
> MR. SCHOLZ: I always keep getting that upgrade to Doctor. Thank you.
>
> You say that you use vinyl and latex.
>
> MR. SCHULZ: Yes; we do.
>
> MR. SCHOLZ: Has the company done any work to determine if one is
> better or is it based on availability? Is it based on costs? Do you
> have any sense of\--
>
> MR. SCHULZ: I guess you need to define \"better\" for me.
>
> MR. SCHOLZ: Longer lasting, less damage, concern for employees or
> consumers who may\--
>
> MR. SCHULZ: I think I have to say they are probably equal because they
> both act as a good barrier. I think that, in my use of latex gloves,
> and we use the examination quality, again, if you want to define
> \"better\" for me, it gives me better tactile when I deal with plates.
> It also provides a little better strength, I would say. It does hold
> up within the operation better than vinyl. That is just my own
> personal opinion in use.
>
> MR. SCHOLZ: Do you have anything, or have you seen anything from the
> manufacturing community, especially those that might compete with
> latex, to suggest why plastic or vinyl might be better?
>
> MR. SCHULZ: I have heard the arguments on both sides. I have been to
> the Food Production Congress. I have listened the scientific debates
> over the years. I have read periodicals. But I will say that we use
> both and they both work fine for us. We even use the very inexpensive
> plastic gloves which we used to be force to use before anything else
> was available. And they work sufficiently as well for specific
> applications.
>
> MR. SCHOLZ: Thank you.
>
> MR. SCHULZ: You\'re welcome.
>
> DR. DWYER: Thank you, Mr. Scholz.
>
> Dr. Gaspari?
>
> DR. GASPARI: You reported rare transmission of Hepatitis A and the
> case of Staph transmission to guests but you didn\'t mention anything
> about any of your guests having complaints that would be suggestive of
> an allergic reaction as a result of exposure to natural rubber latex.
> Has anything like that ever happened and, if so, have you worked with
> the appropriate consultants to identify whether natural rubber latex
> was involved?
>
> MR. SCHULZ: I can remember\--again, in monitoring our Food Safety
> Hotline, which is a twenty-four-hour process we have had in place for
> approximately ten years, I can remember one case, I would say
> approximately nine years ago, where it was made mention to me that we
> did have a guest who said that she had a minor reaction to an allergy.
> Were we ever able to confirm it through testing? At that time, no. We
> did test food, I remember, and I know that we did. Obviously, she had
> a reaction to something but we were not able to confirm exactly that
> it was latex. And it was only one case over the last ten years that I
> know of.
>
> DR. DWYER: Any others? Dr. Hamilton?
>
> DR. HAMILTON: I may have missed this, but in selecting latex gloves, I
> didn\'t understand whether you went for powdered or non-powdered latex
> gloves.
>
> MR. SCHULZ: We use non-powdered. But I will say that, again, in our
> industry, there have got to be people within our organization using
> powdered gloves because\--I would say one other thing. We do audit our
> properties every year for the use of that specific product that says
> examination quality on the package. We do that worldwide.
>
> But I will say that there are probably some markets where powdered
> gloves are sneaking in and they are being used. But, again, it seems
> to be not impacting the numbers that we hear.
>
> DR. HAMILTON: A second question.
>
> DR. TORRES: May I ask a follow up to that?
>
> DR. HAMILTON: Sure.
>
> DR. TORRES: I am confused now because I remember quite clearly on your
> slide the box said pre-powdered.
>
> MR. SCHULZ: We do use some pre-powdered. We do use some non-powdered.
> I will say that that slide doesn\'t\--that is an old slide that I put
> up there. The current recommendation is non-powdered gloves. But,
> again, I will say it this way. In the vastness of our properties and
> the people that I have within there, I am very sure that there are
> people using powdered gloves out there, especially when you have 400
> franchisees and courtyard hotels that we have very little impact over,
> they are obviously using both.
>
> DR. DWYER: Dr. Torres. You get the prize for sharp eyes.
>
> Dr. Hamilton?
>
> DR. HAMILTON: A second question. I was led to believe by your comments
> that you actually monitor the soluble proteins in the gloves and, if
> so, how do you do that?
>
> MR. SCHULZ: I don\'t have the specifics. As I said, I am not a
> scientist. If you would like, I can provide you with information on
> our specifications for the gloves which probably lists the exact
> things that we monitor.
>
> DR. HAMILTON: So you just look for the specification. You don\'t
> actually take gloves from various sites and actually have them tested
> by a laboratory.
>
> MR. SCHULZ: I believe that those are tested at the manufacturer for
> those levels.
>
> DR. HAMILTON: I see.
>
> MR. SCHULZ: We do have thresholds for those different levels of
> materials.
>
> DR. DWYER: Dr. Downer and then Dr. Fischer, and then you can have
> another crack at it.
>
> DR. DOWNER: Actually, Dr. Hamilton asked my question. I heard him
> mention that they were able to test the specifications for the protein
> content of the gloves and I wanted to know how they did that. So you
> asked the question before I did.
>
> DR. FISCHER: I would like to ask whether you keep records of reports
> of allergic reactions or possible latex-based reactions and, if you
> do, could you give us the numbers? I know you said that you have
> little concern. But we kind of like numbers.
>
> MR. SCHULZ: As I mentioned, in the past ten years, I know of one
> singular case of a customer telling us that they have a reaction to an
> allergy based from, we think, gloves.
>
> DR. FISCHER: I am thinking mainly about the workers at this point.
>
> MR. SCHULZ: Yes; we do. We do keep records through our internal claims
> department when people have to pay out medical bills or that we have a
> claim against us from an associate who may have been made ill by the
> use of that as well. I don\'t have an exact number for you,
> unfortunately.
>
> DR. DWYER: Dr. Torres, did you have another question?
>
> DR. TORRES: No.
>
> DR. DWYER: Anybody over here have follow-up questions?
>
> Thank you very much for an interesting presentation.
>
> MR. SCHULZ: Thank you.
>
> DR. DWYER: And thanks for coming.
>
> We have had some good clarifications this morning. Shall we go to the
> telephone conference now, or what is your pleasure? Any other things
> while we are waiting for the telephone to hitch up?
>
> Let me return, you, Committee, to the charge which is on the
> latex-allergy charge to the committee. The reason I am doing this is
> because we have heard a lot of interesting things and, in the end, the
> agency is really only interested in our answers to these specific
> questions. The better we can answer these questions for them or give
> them guidance, that is where the latex hits the road.
>
> Are we about ready to hear from our colleagues up in Rhode Island?
>
> What we are doing now is we are moving up to Dr. Marie Stoeckel who is
> with the Department of Health Services in Rhode Island, in Providence.
> She is going to be talking about their experiences. Again, this is
> another state of, I think, three states we will be hearing from with a
> latex food-service glove prohibition.
>
> Are we going to see her or is she just going to be a disembodied
> voice?
>
> MR. BONNETTE: She is going to be a disembodied voice.
>
> DR. DWYER: Let me just go over the questions while we are waiting. The
> task, again, is to consider the available information regarding
> food-mediated latex allergic reactions and the use of latex
> food-service gloves in establishments that prepare foods for human
> consumption. So it is not the whole thing. It is just that one
> specific thing.
>
> The agency wants to know, first of all\--just yell at me when you have
> got the people in Rhode Island on the telephone\--has the positive
> relationship been established between natural rubber latex gloves in
> food service and allergic reactions to food served in the food
> establishments or sold there, based on what we have heard and what we
> have read. If it exists, what it the strength of that relationship and
> has it been shown to be causative?
>
> The second question we must answer before we will be allowed to go out
> into the rain is if a positive relationship has been established and
> shown to be causative, then they want us to suggest science-based
> options to mitigate food-mediated latex-allergy risk. If current
> evidence, in our judgment, is not sufficient to establish this
> relationship, we need to give the agency the questions to be addressed
> to adequately understand the issue.
>
> Since we are almost to the end, you may want to jot down what you
> think about each of those questions because what we will, as soon as
> we finish hearing all of the testimony, is we will go around the room
> with each question, get everybody\'s views. If we can get a consensus,
> that is fine. If not, we will put on the record our individual views.
>
> Are we ready now? Five minutes? Okay. Let\'s go on to our next\--do we
> have another person testifying? I see one talk here. Is there another
> talk? Can we take public comment now? I guess what we will have is a
> few minutes to just clarify, if you can just\--does anybody have any
> comments that they want to raise on the committee on the general
> charge, the task?
>
> We can go ahead with public comment. I know we do want the benefit of
> everybody for as long as possible, so I would request the first
> individual who wishes to come up for public comment to come up. How
> long do they have?
>
> MR. BONNETTE: Hi. This is Richard Bonnette. We have a list here of
> people that have registered, both at the front desk and also I have a
> list of people that had contacted me. Going in order from the folks
> that came in today, I think we can start with Doris Rittenmeyer. Her
> affiliation is with Food Handler. Is she with us?
>
> DR. DWYER: How long are they\--
>
> MR. BONNETTE: I would ask that the comments be kept to between five
> and ten minutes, please.
>
> DR. DWYER: Ms. Rittenmeyer, thank you for coming and sharing your
> views with us.
>
> **Public Comment**
>
> MS. RITTENMEYER: Thank you very much. It is a pleasure to be here.
> Again, I am Doris Rittenmeyer, National Manager of Safety Management
> Services of Food Handler, Inc., out of Westbury, New York.
>
> We are a leading manufacturer of barrier-protection products for the
> food industry. We manufacture single-use disposable gloves,
> food-storage bags, aprons, nets and chef hats. We are the first
> manufacturer to have achieved the NSF certification protocol, P-155,
> for single-use disposable gloves. This has become an issue with you
> this week on telling the difference between medical gloves, exam
> gloves and food-service gloves.
>
> NSF established the first comprehensive standards for testing
> food-service gloves with the assistance from a panel of experts
> including the NRA Educational Foundation, FDA, CDC, state health
> departments and industry and consumer representatives. Actually, in
> this room, we have two panel members that served on the committee.
>
> The certification provides for strict and rigorous manufacturing
> processes covering the areas of safety which include toxicology\--are
> the ingredients safe for food contact; biocompatibility\--are the
> ingredients safe for skin contact; material specifications; approving
> the ingredients for all gloves and including latex, natural rubber
> latex gloves for the allowable protein levels of the latex.
>
> The second key point in the certification is cleanliness; are the
> plants ISO compliant. Do they have good manufacturing processes and
> procedures? Do they include HACCP plans in the manufacturing plants?
> Part of this criteria includes unannounced yearly audits by individual
> auditing companies, probably Cook and Thurber which is the NSF
> auditing arm, unannounced product testing anywhere within the chain of
> distribution.
>
> The third key point is durability including visual inspection, foreign
> or embedded materials, off-colors and odors, barrier integrity, water
> testing for leaks and pinholes, elongation standards and
> tensile-strength requirements, also including glove-powder levels and
> the appropriate type of glove powder, labeling requirements for how to
> use each and every glove and latex-allergy warning on the boxes.
>
> Also in the protocol, latex sensitivity is addressed in Section 5,
> material specific requirements, and 5.3, natural rubber latex gloves
> shall meet the dimensional physical and quality requirements shown in
> Table 1 when tested according to Section 6.5 through 6.7. In addition,
> natural rubber latex gloves shall have no more than 200 micrograms per
> decimeter squared of extractable protein when testing according to
> Section 6.4.
>
> In Annex B, guidance document for disposable glove usage, natural
> rubber latex. There is a section I am going to leave out because we
> have covered it. We are talking about suitable tasks with a suitable
> glove. We can go there if you would like, but what about allergens?
> This is verbatim from the protocol.
>
> Allergies to natural rubber latex and other chemicals are important
> considerations in glove selection. Managers and food workers must be
> educated about the potential risks associated with the issue for
> workers and consumers. Natural rubber latex gloves have been reported
> to cause allergic reactions in some individuals who wear latex gloves
> during food preparation and even in individuals eating food prepared
> by food employees wearing latex gloves. This information should be
> taken into consideration when deciding whether single-use gloves made
> of natural rubber latex will be used during food preparation.
>
> Of course, the source for this is the USDA FDA 1999 and 2001 Model
> Food Code.
>
> The above sections are verbatim from the NSFP 155 protocol for the
> manufacturing of disposable food-contact gloves. With appropriate
> standards for the manufacturer, high-quality, low-protein, natural
> rubber latex can be an option to reduce the risk of latex allergies
> associated with food.
>
> Food Handler, Incorporated, has proactively developed end-user
> education in the way of React to Latex, which is an end-user campaign.
> We have also developed a portion of our Crew Safety at Work training
> modules on latex allergies so the education is there for the end user.
> We have also developed a proper gloving video, Safe Hands, Safe Food.
> This leads from our association with the Hand Washing for Life Forum,
> of which we are a founding sponsor.
>
> We, and other glove companies, offer alternative glove choices to the
> food-service workers such as vinyl synthetic and nitrile and, of
> course, powder and powder-free choices. Our company alone offers
> fourteen non-latex choices plus powder-free low-protein in our natural
> rubber latex gloves.
>
> In closing, Food Handler has appreciated speaking in front of this
> group. I do have a copy of the protocol if the committee would be
> interested in having a copy of this. I think it is appropriate for you
> to have this. We work very closely with the National Sanitation
> Foundation in developing\--and not necessarily we as a company\--in
> developing the protocol because that was done by a committee of
> individuals selected by the National Sanitation Foundation.
>
> But we are very proud to say that we are the first company that has
> what is now classified as a food-service or food-contact glove to be
> used in the food-service industry. So the requirements, the
> certification, is there for other companies now to achieve.
>
> Thank you.
>
> DR. DWYER: Thank you. Would you please leave a copy of that so we can
> take a look at it as we deliberate further today.
>
> MS. RITTENMEYER: I will. Thank you very much.
>
> DR. DWYER: Thank you so much, Ms. Rittenmeyer.
>
> Are there any questions?
>
> DR. TORRES: There have been a lot of questions about the cost of the
> different glove alternatives. Can you tell me what the cost is between
> powder-free, protein-free, so I have a sense of the numbers.
>
> MS. RITTENMEYER: I am sorry; I can\'t. I am not in the sales
> department. I am in the Safety Management Services Department and
> these are the kinds of things that we do. I would certainly be able to
> get that information you and get it to you if you would so choose.
>
> DR. DWYER: Thank you very much.
>
> DR. HAMILTON: Could I ask a question?
>
> DR. DWYER: We have got one more and then we will go to the telephone.
>
> DR. HAMILTON: Could you, again, redefine for me single-use disposable
> gloves because I am unsure what single use means? Is it putting it on,
> touching something and taking it off?
>
> MS. RITTENMEYER: We look at gloves as task-specific. So if you were
> doing the same task\--if I am making sandwiches through a lunch period
> at a deli and I am not doing any other tasks, as long as the glove is
> in good condition, I haven\'t touched anything else, whatever, that is
> considered a single-use glove.
>
> We do not time-period our gloves as we don\'t time-period
> hand-washing, either. It is a task-based situation.
>
> DR. HAMILTON: Does your recommendation, or does the recommendation
> there, discuss the issue of powdered versus non-powdered gloves?
>
> MS. RITTENMEYER: It is addressed in the protocol, if that is what you
> are asking.
>
> DR. HAMILTON: Powdered gloves are included?
>
> MS. RITTENMEYER: Yes,
>
> DR. HAMILTON: As the recommended product?
>
> MS. RITTENMEYER: Well, they are not\--this is a protocol and it is up
> to you to decide what is best for you in your facility, whether it be
> powdered or powder-free. But we do offer, again, the powder-free,
> low-protein, latex glove as a option for you.
>
> DR. DWYER: Dr. Gaspari?
>
> DR. GASPARI: Do you have any reporting mechanisms where you receive
> reports of adverse events associated with the use of your gloves?
>
> MS. RITTENMEYER: Yes; we do, in the office. It would be available.
>
> DR. GASPARI: Can you share any of that information with us?
>
> MS. RITTENMEYER: I don\'t have it off the top of my head; no.
>
> DR. DWYER: Thank you, Ms. Rittenmeyer, for your comments? Are there
> any others?
>
> We are going to turn, now, hopefully, to Rhode Island and hear Marie
> Stoeckel who is going to speak about latex food-service prohibitions
> in Rhode Island.
>
> **Invited Comment from a State**
>
> **with Latex Food Service Glove Prohibition**
>
> MS. STOECKEL: Good morning. I am going to talk about latex-glove
> legislation and regulations in Rhode Island.
>
> If I could have the first slide.
>
> This is a history of the background that led to the legislation. In
> 1997, Dr. David Kern, who is an occupational-health physician, advised
> the Rhode Island Committee on Occupational Safety and Health, which is
> a union-sponsored organization for worker safety and health\--he
> advised them that latex allergy was an emerging issue in healthcare in
> the area.
>
> In response, RICOSH worked with the United Nurses and allied
> professionals and the Rhode Island State Nurses Association to start
> to obtain anecdotal information from nurses. They found that latex
> allergies were not uncommon and were told that many coworkers had left
> healthcare because of the problem.
>
> RICOSH brought this issue to the Department of Health in December of
> 2000. In response, we formed a workgroup specifically for education
> and outreach efforts and we started meeting as a group in March of
> 2001 and included representation from unions, a worker\'s comp
> insurance company and the Attorney General\'s Office.
>
> It is very important to note that the then-Attorney General, Sheldon
> Whitehouse, has a son. The son at the time was about seven and is
> highly allergic to latex products. As a result, Attorney General
> Whitehouse was an enormous advocate for pushing forward the issue of
> latex-allergy prevention.
>
> The next slide please.
>
> At the same time we started to meet as a workgroup, one of the state
> legislators sponsored very controversial legislation to ban the use of
> latex gloves in healthcare facilities. There was a very vigorous
> response of opposition from lobbying groups which was led by
> Allegiance through the glove manufacturers, Rhode Island Hospital
> Association, the Rhode Island Medical Society and the Rhode Island
> Dental Society.
>
> In response, the legislator withdrew the ban legislation and submitted
> much less controversial legislation which did pass which merely
> declared the first week in October as Latex Awareness Week and
> required the Department of Health to sponsor educational seminars for
> three areas; healthcare, child care and the food industry.
>
> At the same time, the workgroup was expanded to include the lobbying
> group for balance and included the people from Allegiance, the
> Hospital Association, the Medical Society and the Dental Society. We
> did a lot of collecting of information, had a lot of speakers come in.
> We had very animated discussions and we basically divided on two sides
> of the issue.
>
> As a result, we still needed to move forward on the Latex Awareness
> Week so the Director expanded the workgroup in September and he moved
> forward to finalize the education and outreach chapters.
>
> Once we disbanded, the Attorney General did a really wise thing and he
> invited all the members of the workgroup to join his newly formed
> Latex Allergy Advisory Task Force. In addition to the workgroup
> members, he invited representation from every hospital in Rhode
> Island, which is a very doable thing if you know the size of Rhode
> Island. I think it represented thirteen hospitals or hospital groups.
>
> Anyway, through a series of meetings, he was able to bring the group
> to consensus to support legislation which was submitted in 2001, which
> I will talk a little bit about in a few seconds. His success was, of
> course, due to the presence of the hospitals who had, through
> worker\'s comp costs recognized the cost associated with employees
> developing latex allergies and had already implemented or were in the
> process of implementing various education and minimization programs.
>
> The other reason the legislation went forward very well is that the
> task force members were included in the actual drafting of the
> legislation. This was a very satisfying participation for the lobbying
> group and that the task force members continued to be involved in
> outreach activities for the next year\'s Latex Awareness Week. Then
> we, at the Department of Health, when it came to drafting the
> regulation, included these same people as our stakeholders so that we
> had their input in the final regulation.
>
> The next slide please.
>
> In brief, I know one of the things you wanted to know was what we used
> as our scientific basis for the decision to move forward on the Latex
> Glove Safety Act. I am just going to quote directly from our
> legislation, the five bullets that are in our preamble.
>
> As you can see on the slide, we noted that latex allergies are
> increasingly becoming a problem for people exposed to latex gloves in
> various industries. We reference the American College of Allergy,
> Asthma and Immunology conclusions. We reference the 1997 NIOSH Alert
> and the 1999 OSHA Technical Bulletin and then finalized with the NIOSH
> conclusion that latex allergies are preventable.
>
> Slide 5, please.
>
> The legislation passed without opposition which includes without
> opposition from the food industry or Hospitality Association. The
> Department of Health in our support of the bill, I wanted to point out
> some of the things that\--
>
> DR. DWYER: Could she speak up, please.
>
> MS. STOECKEL: I\'m sorry. The Rhode Island Department of Health
> supported the legislation. In our letter of support, we noted the
> following. We recognize the potential for allergic reactions in some
> individuals using natural rubber latex products, particularly gloves.
> We advocate the prevention of unnecessary exposure to latex through
> education of employees and the public.
>
> We encourage voluntary management strategies to reduce the use of
> disposable latex gloves while recognizing the importance of
> maintaining safety where workers are exposed to bloodborne pathogens.
> And we support the elimination of the use of disposable latex gloves
> in industries where exposure to bloodborne pathogens is not a healthy
> thing, including the food industry.
>
> Next slide please.
>
> I am going to give you a very few brief bullets of what is in the
> regulation, which are relatively short. The regulation pertains to the
> latex gloves by healthcare workers in licensed healthcare facilities
> and by other persons, firms or corporations licensed by the
> Department. These were finalized in May of 2002.
>
> In essence, they only pertain to entities licensed by the Department
> of Health. So the one that you are interested in is the that
> regulation prohibits the use of disposable non-sterile and sterile
> natural rubber latex gloves in licensed food establishments.
>
> Within areas of healthcare providers and licensed healthcare
> facilities, the regulations require initial and annual in-service
> education on latex safety for healthcare workers and they also require
> in the same facilities that healthcare workers be represented on
> either latex allergy or safety committees.
>
> The last two bullets pertain to the entire universe of organizations
> licensed by the Department of Health. Other than in food
> establishments, if latex gloves continue to be used in a facility,
> there has to be a posting of a notice right at the front entrance or
> in a public place that natural rubber products, gloves, are used in
> the facility and that gives several bullets as to the risks associated
> with exposure to the gloves.
>
> In addition, in all entities licensed by the Department of Health, it
> is required that they look at how to minimize their use of latex
> gloves. It includes evaluation of symptoms, evaluation of the
> feasibility of replacing latex gloves with non-latex-gloves, and
> assessing the impact of preventive measures.
>
> These certainly apply to healthcare facilities but, in Rhode Island,
> at the Health Department, we license everything from acupuncturists to
> X-ray facilities and a lot of things in between. So it applies to all
> of them.
>
> The last slide, please.
>
> In summary, with respect to the food industry, the components of the
> Rhode Island legislation that included the banning of latex gloves in
> the food industry did not raise any controversy and appeared to be
> supported by the industry and by its Hospitality Association.
>
> In Rhode Island, we have a food code which includes certified food
> handlers. This has provided an excellent mechanism for communicating
> the latex-glove ban to the industry because of the ongoing training
> requirement. In addition, we have continued to hold outreach
> activities during Latex Awareness Weeks focusing on the industry as a
> concern.
>
> In addition, the members of the Attorney General\'s task force
> continue to be advocates for the latex-glove ban in restaurants. They
> developed flyers. Everywhere they go, they are on purple paper, which
> is the color for the latex awareness, and they distribute them at
> restaurants and among the press.
>
> But the thing that I wanted to share with you last is that most
> compelling testimony for banning latex gloves in the food industry
> came from members of the community who are highly allergic to latex.
> They explained it is very challenging for them to eat in restaurants,
> or at least it was prior to the ban, and they would have to
> call\--even if they had been to a restaurant two weeks ago, they would
> call the day they were planning to go to make sure that they weren\'t
> using latex gloves.
>
> Anyway, that is conclusion of my presentation.
>
> **Questions of Clarification**
>
> DR. DWYER: Thank you very much, Ms. Stoeckel, for your interesting
> presentation. There may be people around the table who wish to ask you
> questions, if you can hear us.
>
> If you do ask a question, I suggest you put your hand on the mike
> because it seems to quiet things down.
>
> My question comes from being in a neighboring state. If I walked into
> some life-span hospital in Rhode Island or into Il Forno, how good is
> the enforcement of this regulation?
>
> MS. STOECKEL: We do it the best we can. I think, overall, it is going
> quite well. We have not a full complement of inspectors but we do get
> out to as many restaurants as we can, clearly, and we certainly get to
> the startup restaurants and we get to the restaurants where there are
> complaints.
>
> The Hospitality Association has shared the ban, information on the
> ban. We have the Awareness Week, outreach activities going on and all
> certified food handlers, of course, include this as part of their
> curriculum. So the word has gotten out. If we get a complaint, we
> certainly enforce the regulation.
>
> DR. GASPARI: I have a question. Does the ban extend beyond restaurants
> to industry where food is processed and subsequently marketed to a
> restaurant? Is it all phases of food handling or preparation or is the
> ban on the NRL gloves in restaurants alone?
>
> MS. STOECKEL: It pertains to all facilities that are licensed under a
> general law requirement. So I believe it is everything that is
> licensed by our Office of Food Protection.
>
> DR. GASPARI: In your history of your process, you described a number
> of sources of information that sounded like they were instrumental in
> making your decision. The first thing\--I jotted some notes and I
> thought one piece of information that you gleaned was information from
> nurses where \"latex allergies were not uncommon.\" That was one
> source.
>
> Secondly, then, there was information on latex allergies from primary
> and secondary sources. Third sounded like there was a source of
> information from workman\'s compensation. Then, fourth, it sounded
> like you used basically statements from QuadAI, NIOSH and OSHA and all
> of these sources of information were used in your decision-making
> process.
>
> So, if it is possible, would you be able to expand on what were the
> primary and secondary sources and, if you did some in-state studies on
> healthcare workers such as nurses, would you be able to provide us
> with some information about the adverse events suffered in those
> populations, and also the relative role of what I think are the four
> major sources of information that you used in your decision-making
> process.
>
> MS. STOECKEL: We did have some worker\'s comp data which was not
> overwhelmingly convincing of the issue, the anecdotal information,
> which was not really documented. It was more people would come and
> testify. They represented groups like elastic or they were nurses who
> were no longer working or they were nurses who were able to work
> because their hospitals had accommodated them.
>
> So I don\'t have any written documentation rather than could get
> access to the current worker\'s comp data. Then, in terms of the
> literature, it is the literature that you all have access to. We had
> speakers from the University of Massachusetts at Lowell\'s Sustainable
> Hospitals Group explain to us about alternatives to latex gloves.
>
> We reviewed the New Jersey guidelines and, of course, the NIOSH and
> OSHA and American Academy of Allergy and Asthma data. But, in terms of
> our own\--when I said primary, I probably should have said people came
> and talked to us directly. But I wouldn\'t say that we did primary
> research. I may have confused that term.
>
> DR. DWYER: Dr. Johnson and Dr. Downer.
>
> DR. JOHNSON: Dr. Rachel Johnson. In your last slide, the last bullet,
> it said that some compelling evidence was the testimony from people
> with latex allergies who had a fear of eating on restaurants.
>
> My question is two-fold. One is, did you have testimony from people
> who actually had reactions, allergic reactions, from food that they
> consumed that they believe was contaminated with natural rubber latex
> and, two, is that testimony in the public record, in the Rhode Island
> public record, that FDA would be able to get a copy of?
>
> MS. STOECKEL: I have some notes in my files. If that is public record,
> you are welcome to that, but it would be almost easier to put you in
> touch, if you wanted, with the two people who gave the testimony. So I
> could actually get their names and numbers if you want and you could
> talk to them yourself.
>
> DR. DWYER: Dr. Downer has a question.
>
> DR. DOWNER: Thank you. With this ban, what system have you put in
> place in your state to prevent cross-contamination? Are you doing
> hand-washing, too? Can you tell me a little bit more about what you
> are doing in the absence of using rubber latex in the industry?
>
> MS. STOECKEL: I can\'t hear the question.
>
> DR. DWYER: I am asking, with the ban in your state, what system have
> you put in place to prevent cross-contamination since you are
> advocating no longer using the rubber latex gloves. Are you advocating
> hand-washing, non-latex gloves, vinyl gloves? What are you
> recommending?
>
> MS. STOECKEL: The question is what are we recommending instead of
> latex gloves? I am still having trouble.
>
> DR. DWYER: Yes.
>
> MS. STOECKEL: In our Food Code, food that is not going to be cooked
> can\'t be handled with the human hand. They can use tongs. They can
> use deli papers. And they can use any appropriate glove that is not
> latex.
>
> DR. DWYER: Dr. Johnson had another question, and then Mr. Scholz.
>
> DR. JOHNSON: I don\'t have another question. I just didn\'t get an
> answer to the first part of my question, if any of those
> testimonies\--were they from people that had a fear of eating in
> restaurants or did they actually have a reaction?
>
> MS. STOECKEL: I am a little fuzzy. It goes back three years. My
> perception was that at least one of them had had a reaction. I didn\'t
> review that prior to preparing this. I was doing this based on
> recollection. So, if you can forward me your name and how to reach
> you, I would be happy to get you whatever I have on the subject.
>
> DR. DWYER: Mr. Scholz.
>
> MR. SCHOLZ: Back to the Food Safety Code. When you banned the use of
> latex gloves, did you do anything with the retail community to relieve
> them of any viability because they are not using gloves and, as I
> understand it, you are just requiring hand-washing. But do you require
> it at every change and have you done anything to relieve the retail
> community of liability that may come from any kind of incident of food
> poisoning or anything else that may happen?
>
> MS. STOECKEL: You cannot use bare hands if it is not going to be
> cooked. You have to use tongs, deli papers or gloves. Are we
> communicating okay?
>
> MR. SCHOLZ: I\'m sorry; so you still require gloves just as long as
> they not latex.
>
> MS. STOECKEL: Absolutely. You have to have\--you can\'t handle food
> with your bare hands. Just don\'t use latex gloves. There is no reason
> to use latex gloves.
>
> DR. DWYER: Any other questions for Ms. Stoeckel?
>
> We enjoyed the presentation. Thank you for being on the telephone. I
> think we can sign off, now. Thank you very much, Ms. Stoeckel.
>
> MS. STOECKEL: Good bye.
>
> DR. DWYER: We can return to our public testimony. Our next speaker
> will be Wava Truscott. Wava Truscott is representing Kimberly Clark
> glove manufacturing.
>
> **Public Comment**
>
> DR. TRUSCOTT: My name is Dr. Wava Truscott. It is Cherokee. To be
> fair, and to expose all other biases, about 20 percent of my
> retirement is in Marriott. I have been working with the glove issues
> probably since about 1987, so it has been a long time with
> gloves\--other products as well, but a lot of gloves.
>
> Just to look at Kimberly Clark, to see what we represent, we have
> about 26 percent of the medical-examination glove market. In
> descending order of volume sold, so that we realize we have got each
> of the different types of gloves, we have powder-free latex, our
> largest volume. We have powder-free vinyl, powder-free nitrile,
> powdered latex, powdered nitrile and powdered vinyl. That is in our
> medical-examination group.
>
> We also sell to consumer markets. We sell examination gloves to
> consumer markets at Sam\'s or CostCo or any of those places. We have
> industrial scientific gloves, which would be for your semiconductor
> use. Certain cleanliness is required in order for specification so
> they don\'t damage the various circuitry. And then we have general
> consumer gloves. That might be your Home Depo, again, any of the large
> retail places, which anyone may buy, whether it be painters
> handling\--out in the garden, or anything else.
>
> This is going to seem like a hodge-podge. I just put this together
> last night for some of the questions that were asked to try and
> address some of those. So jot down if I am not explaining it correctly
> and I also, because I did hurry it last night, may not catch
> everything.
>
> But, in general, for examination gloves\--not surgical\--we also have
> surgical, but that is not the topic for today\--the FDA requirements
> for examination gloves would be exact requirements on AQL, acceptable
> quality level, which would be the limit on the major defects, like
> pinhole leaks, or leaks, coming out of box, not in use\--out of the
> box.
>
> Then, also, the statement contains natural rubber latex is required,
> or a similar type statement. They also, and I didn\'t put this down,
> require for it surgical gloves and it is routinely required for
> examination gloves even though it is not adamant. But it is the dermal
> testing, primary skin irritation, and repeat-insult guinea pig, or
> guinea pig max.
>
> The ASTM, which is the American Society of Testing and Materials, are
> a group of the manufacturers. It is the manufacturers but it also is
> composed now, about the last decade\--about one-third of them is
> usually other interested parties, latex sensitivity groups or whoever
> might feel that they had an interest in the particular topics going on
> at that time. There are always new rules and regulations being
> developed by this particular group.
>
> In a way, you might say that this is the fox in the henhouse. But,
> indeed, we have got to regulate our own industry or we are up for
> litigation or particular\--that is a quote\--or particular other
> issues that might arise. We want to keep the standards up in order to
> keep the industry up.
>
> What are some of the standards that we have put out in this last
> decade? It is the test methodology and, again, working with the FDA
> and other interested groups, NIOSH as well, protein max on gloves is
> 200 micrograms per decimeter squared. It used to be per grams. Now it
> is per decimeter squared, that surface bit. And also how to do the
> test, to make sure that glove is extracted correctly and the same from
> one lab to another.
>
> It also has a powder maximum of 10 milligrams per decimeter squared. A
> powder-free must no more than 10 milligrams per entire glove.
> Basically, you take a flask and you put the glove in it and you shake
> the dickens out of it for a specified amount of time. You pour it
> through a filter. That filter is then dried\--it is preweighed and
> then the powder goes through, and then dry it and then you weigh it
> again and you just determine the amount of powder.
>
> For powdered gloves, you do it several times so you really get all the
> powder off of it. Then there are dimension specifications. There are
> tensile-strength requirements. There are elongation minimums. There
> are two right now for the ASTM. This is why this is so important for
> us. One is a color restrictiveness so that, as I go into a facility, a
> medical facility\--let\'s say there is an emergency decision being
> made the a nurse grabs a glove, is it important for that nurse to be
> able to know that she is grabbing a synthetic glove or a latex glove.
>
> If that is true, then that glove should be restricted as far as color.
> Right now, it has to say it on the box. Is it important for the
> natural rubber latex to look like natural rubber latex or synthetic to
> look like synthetic and the two not mix. That is up before the
> committee right now.
>
> Also, a latex-restricted food handling in gloves is right now before
> ASTM. Should that be restricted so that there are no natural rubber
> latex gloves in food handling or should they be powder-free or a
> certain protein requirement. So we are trying to make those decisions
> right now. And many other things, too, but not relevant to right now.
>
> In the food-handling gloves, in the \'80\'s, there used to be \"USDA
> approved,\" to put it on your box. It meets these requirements. USDA
> has read through what was in your glove and then say\--they bless it.
> They say, \"Okay; you can now stamp it.\" That was stopped in the mid
> to late 1980s. Now, you are self-governing.
>
> Actually, what we do is we send what our glove components are and
> answer questions to a legal group, an outside legal group, who then
> tells us yes, \"That is good for food handling,\" so that when
> Marriott or some other large group calls and asks us about the glove,
> we can say that it meets those requirements.
>
> But Mary Jo down the street with her donut shop or something like that
> is not going to be calling us. This would be the large groups who buy
> in large volume. Latex protein has not been a question that has been
> asked, at least in my knowledge.
>
> Medical-glove rejection, rejects as food gloves, was one of the issues
> brought up yesterday. That sounds awful when you first state it. There
> are requirements for medical gloves. As you were seeing in the
> Marriott, if they require medical gloves, this would not be the case.
> But if you don\'t require medical gloves, you don\'t have quite the
> same requirements as would be required in medical gloves. That was
> roundabout.
>
> If I have a reject because of a blemish, because the color is mottled,
> it looks white and it looks yellow and it looks this and it looks
> that, or if the cuff is to short, such as the dipping tank was allowed
> to get too low so it doesn\'t meet that medical-glove requirement, it
> would then be allowed to be in the consumer market that does not have
> a strict requirement.
>
> So, in that case, for us, it is kind of easy because they come off the
> same line, as Dr. Hepp was referencing. Many manufacturers just make
> for the consumer market and would not fall into of those requirements,
> either protein or powder or length or anything else. So it is going to
> be a real hodge-podge mixture of the quality of the latex gloves.
>
> Latex gloves, away from the former. I think most of it was handled
> yesterday. That which is next to the former, or the mold that looks
> like a hand, will be\--it is a hard surface, so, as it goes through
> all the leach tanks and everything else, it is actually like a sponge.
> It goes into the ovens which are about 300 degrees Fahrenheit for
> about ten minutes so you are really heating it up, you actually have
> the expression of the proteins, mainly to the outside, not only
> because the aqueous situation but even more because the coagulant is
> put on the mold before you ever dip it in the latex and, thus, it is
> the most dense as far as coagulating and forces the protein outward.
>
> So you have about ten times more on that outside of the glove. Since
> most people invert it, the outside of the glove would be lower. But
> that is not always the case, as stated yesterday.
>
> Now, as it comes out of the ovens, if I, right then, rinse it off, I
> will take care of about\--since so much is right there on that outside
> of the glove, away from the mold, if it gets out of the oven when all
> the proteins have been expressed to the surface, and I spray it off or
> wash it, I will take off, within seconds, about 75 percent of the
> protein. So it is really nice to be able to take it down rapidly.
>
> I will never touch, though, what is on the other side of glove if I am
> doing it on line. That thought process is what worked towards that 20
> micrograms per decimeter squared. If I can rinse it off that
> thoroughly, that rapidly, looking at some standard deviations for some
> sort of error, I should be able to get down to 80 to 100 micrograms
> just with that simple wash-off. Standard deviations, then, would take
> me up to 200 for safety and there you have the 200 micrograms per
> gram. Thus, we thought to ensure at least all gloves would be at least
> washed on one surface.
>
> The direction right now is ASTM and FDA, too, is to look at the ELISA.
> As explained earlier by Dr. Hamilton, we are looking at the antigenic
> protein, that which the body recognizes. As we will see in a slide a
> little bit later, that probably represents about 60 proteins. There
> are about 240 different peptides in latex as it comes out of the tree.
> About sixty of them are antigenic and that is ball-park and about
> thirteen, as we saw yesterday, are allergenic.
>
> There are some problems, now. One is that there is a new thing which
> is very good. I am trying to be honest and just open on the different
> facts. Some of them are going to be on one side and some are going to
> be on the other. One of them is enzymes, pretreating with enzymes,
> excellent for eating up, chopping up, the allergenic epitopes. It is
> really degrading the epitopes.
>
> So that is great. So you will come really, really, really low on your
> ELISA and probably your RAST, as well, or allergenic testing. The
> problem is you now have a lot of protein on the surface of glove or on
> the inside of the glove. So when rules are set up, I would highly
> recommend that it is both, at total protein and an ELISA, if we are
> going to go ELISA, so that it would also take care of any of these
> enzymes that might be left on the surface of the glove.
>
> Right now, with ASTM, you can actually go either/or. It is the total
> protein of the 200 micrograms per gram, as we saw earlier, and I
> forgot to put on the slide, it is 10 micrograms per decimeter squared
> for the ELISA test, the antigenic.
>
> This is powder, just as an interest, powder on the surface of the
> glove, and where it would be picking up the protein, either in the
> slurry tank or on the surface of the glove.
>
> One of the things that is not asked on the USDA questions is what is
> just on the surface of the glove, or I should say it is often not
> interpreted. That would be what might be in your slurry tank or
> something like that which is assumed to be really not being mixed into
> the glove. But the coagulant portion, before you dump in the latex,
> has calcium carbonate, calcium nitrate, modified corn starch on some
> of the gloves, cellulosic materials, surfactants, magnesium oxide,
> propylene glycol, phenolic derivatives, waxes and silicones, different
> things that are an issue.
>
> When you chlorinate or remove these, these would be taken away. But if
> you leave it on in a powdered glove, many of these will remain. Not
> every glove will have every one of those. That is an across-the-board
> type thing.
>
> On the other side, which would become the donning surface, would be
> the powdered glove. It is not the cornstarch you eat. It is cornstarch
> that is cross-linked with phosphorous\--epichlorhydrine is phosphorous
> oxychloride. Donning powders, themselves, would absorb anything on the
> surface, not just the protein. They will also take anything that is in
> the glove that ekes to the surface or leaches to the surface. It is
> not gone yet. That would be thiazoles, thiurams, carbamates.
>
> Modified cornstarch, the sodium hydroxide, the surfactants, the
> magnesium oxides, biocides, extremely important. If you take a pipette
> and go down every foot in a slurry tank which is the powder suspended
> water and all the other things that we see before us, it will have
> anywhere from 108, very aerophilic. You will go to more dependent and
> microaerophilic, clear down to severe anaerobes.
>
> As you go down, then, you are going anywhere up to 1012 organisms.
> Thus, the biocides to control that, or the cooling of the units. And,
> as was stated earlier, you end up with endotoxins as well, not an
> issue probably in food handling, but the organisms are. These are exam
> gloves. They are not sterilized, remember. Ammonium salts, sulfurs and
> magnesium oxide, calcium carbonates.
>
> This is the manufacturing process. We were talking yesterday about
> changing in manufacturing. Just to give you an inkling, that unit will
> produce about 10,000 cases a month. Now, if you multiply that out
> times the number of gloves and everything, that is about a million\--I
> think. Yes; a month.
>
> We have 80 to 90, they are just about up, such lines. So it is lot of
> gloves. It is a lot of lines. It is a lot of machinery. It takes up
> about\--it is a little bit longer than a football field, about a
> football field and a half, and it is four stories tall. So, rather
> than this, it goes up to do all of this.
>
> Just to point out, just so that it makes sense, and there will be a
> purpose in my madness, I promise, you will notice that it goes into
> the coagulant here on the yellow. We clean the formers. We then are
> going up and dipping into the latex. You are setting it just a moment.
> It is still gel. If I touch it, it will fall apart.
>
> It goes into two or three or four leach tanks depending upon the glove
> and the manufacturer. They are usually about 55 to 65 degrees
> centigrade. Then, this is what you do, now. They go into the oven at
> 300 degrees for ten to twenty minutes, and you come out and rinse it
> off and then put it in the powder, the slurry. And then you need to
> dry it and clip it and then process it further.
>
> Historically, this is what used to happen in the late 1980s. Instead,
> they went in the leach tank and then they went into slurry. Then, you
> have the old, meaning used to be, donning powder would come on right
> after you go through the leach tanks, donning powder, then go into the
> oven so it bakes it onto the powder. Then you had much higher protein
> content, historically.
>
> Now, instead, we let the protein come to the surface, then rinse it
> off and then put it in the powder slurry. That is why even your powder
> gloves are much lower than they used to be.
>
> DR. DWYER: I need to stop just for a moment because you have run over
> your time.
>
> DR. TRUSCOTT: I\'m sorry.
>
> DR. DWYER: We need to ask the committee if they are willing to listen
> for a few more minutes while you finish up. Is that all right.
>
> Please go on, then.
>
> DR. TRUSCOTT: I apologize. I will try and hurry. That is the
> manufacturing. If you are going to make a powder-free glove, normally,
> you would then go ahead and chlorinate it. The chlorinating, you rinse
> them, you chlorinate them, you neutralize them with a sodium or
> ammonium hydroxide. You then rinse with treated water, multiple
> rinses, maybe deionized water for a surgical glove. You dry it,
> package it and sterilize it.
>
> So you are cleaning off all those things we talked about. So that is
> cool. You can see on it chlorination is an aspect that involves quite
> a few different types of things. If you do it improperly, it can
> affect many different things. It can impact. So there are negatives if
> you don\'t chlorinate properly. This has a purpose, I promise.
>
> If it is a surgical glove, you take every single glove manually, turn
> it inside out, and do it again. Exam gloves allow the water in and out
> enough that you don\'t have to manually reverse every one of them. So,
> you were talking about the difference in prices. For an exam glove,
> you are talking the difference between about 3 cents apiece and now
> you are going to talk about 4 cents apiece. It used to be much more,
> but volume has dictated a lower price.
>
> This is just a pictorial exam of what has been brought out this
> morning. The modified Lowry shows the total protein which is about 240
> proteins, peptides, coming out the tree. The antigenic are about 60
> with a the LEAP or the ELISA test. Then we have the allergenic of
> about 13 and each individual is only allergic to a certain number of
> those.
>
> Now, there is a little bit of misunderstanding today. Latex gloves are
> made from latex. It is the liquid stuff. Anything that you dip, like
> condoms, like gloves, like balloons, they are natural rubber latex,
> meaning that liquid dipping stuff.
>
> The hard rubber is coagulated after it leaves the tree and then you go
> ahead and make crumbed rubber, dry rubber, all that hard stuff like
> with tires, like with injection ports, your combs that are hard
> rubber. They go through a totally different process. They don\'t stay
> liquid. They tap the tree. You coagulate the latex, press it out,
> mince it, wash it, compress it back together, repeat this several
> times. This is for the hard rubber blocks. You form it into blocks or
> sheets for transport, mince it and add solvents to dissolve it so that
> you can go ahead and put it in a molded product. So you can see,
> through all of this, you really wash out, get rid of and then denature
> a lot of the remaining proteins. Thus, it has much, much lower
> amounts. Your conveyor belts and many of your valves would be the hard
> rubber.
>
> This is early experiments in transportation. Just as we talk about how
> low protein the powder-free gloves are, and that is very, very true.
> They have been very, very low, less than 50, less than the measurable
> amount by chlorination. However, there are new methods. How do we make
> that less expensive so people can use more of the powder-free gloves.
> Part of it is using coatings so that you can just whip it off the mold
> without ever having added powder.
>
> The problem with that is you don\'t go through all these washing
> processes I just went through, the chlorination. You might use some
> on-line washing but not this other because that is expensive, very
> labor-intensive stuff.
>
> So I do fear when we talk about just going powder-free that we may end
> up, in the future, with some situations where we will have high
> protein. So you may say powder-free plus a certain level of protein or
> antigen.
>
> Some of these would be the enzyme work, like I mentioned, but also
> just these coatings that are supposed to trap the protein which may,
> or may not, work during use.
>
> From yesterday, water-extractable protein is aqueous leach, aqueous
> spray rinse, aqueous extract for protein determination. All those are
> aqueous, underlined. But some proteins in natural rubber latex are
> hydrophobic, such as rubber-elongation factor. We get them off because
> they are just washing off their loose proteins and they are there. But
> the fact is, we may be pulling out more as it is handling something
> like the raw hamburger or something. We just really don\'t know. Not
> enough work has been done on that.
>
> Yesterday, we also talked about 80\--oh; I\'m sorry. We didn\'t talk
> about this but we talked about expiration dating. When you get a
> glove, when we release it from the factory, it is usually 80 to 85
> percent cured. That means some of it still has open bonds.
>
> Now, as time goes on, we will actually bind it together with the
> sulfur that is still present in the proteins and other components in
> the glove, and we will actually continue to age that glove and be
> perfectly optimal, hopefully, as it is hitting the hospitals. It may
> be about 90 percent. But that way, it has a time of which it will be
> at that maximum tensile strength and a really strong glove.
>
> While it is doing that cross-binding, it will actually decrease in
> protein content because you are trapping more of the proteins. So at
> least historically what we have found is a decrease in protein level.
>
> Thoughts. Powder-free, low antigenic or low-total-protein latex may
> not transfer a significant amount to foods. That was presented
> yesterday. We don\'t know that for sure. We do know that people have
> reacted to foods that have been handled with latex gloves.
>
> Most powder-free gloves are extremely low protein but not all and the
> possibility of a larger percentage of powder-free gloves with higher
> protein counts is increasing because of these advances in technology.
> Enzyme-treated low-antigenic protein gloves can be high in total
> protein because they are just looking at antigenic, may look at just
> antigenic.
>
> Food that is washed after being handled by latex gloves may not have
> residual protein. Natural rubber latex protein on food that is
> subsequently cooked may be adequately denatured so that epitopes are
> no longer recognized. They are submitted to 300 degrees for about five
> or ten\--ten to fifteen minutes but not necessarily higher amounts.
>
> But, you know what? It may just be easier to go to synthetics so you
> don\'t have to stop and think, what am I handling, what am I doing, in
> each situation.
>
> DR. DWYER: Thank you. Are you almost finished?
>
> DR. TRUSCOTT: I am. I am almost there. There were some questions about
> the different barrier properties. Here are some of the last decade.
> There are two more most recently by Dr. Kerr and Dr. Komiewicz, but
> they replicate what is up there. Natural rubber latex is a better
> barrier than vinyl by far, in use. Not out of the box. Same rules as
> far a pinholes, but, as you start manipulating, vinyl does fall apart
> much more rapidly.
>
> Polyethylene would even be more rapid. A nitrile is a very strong
> glove but it is not necessary for all applications. So there is always
> a tradeoff when you are looking at what glove to use.
>
> We put out a request just recently from ASTM to talk about this food
> handling. We put it out to all of these people that you see here. This
> was about two or three weeks ago. Unfortunately, I was not aware of
> this meeting so the deadline is more like a December deadline. But you
> can see all the different organizations, individuals, latex support
> groups, medical professional groups, that would have any interest in
> something like the food handling but also the color initiative\--and
> asked them, as you see here in this comment, to just put in their
> comments, pro or con.
>
> So far, and you haven\'t seen it yet but it is in the packet, I think,
> for you to review, comments we have received so far. But,
> unfortunately, we don\'t have a lot in yet. A lot are still coming.
>
> We have asked them to send their comments to the following people. So,
> pro or con, we expect it to go to, I think, the people who need to see
> it and will come to you as well as it continues.
>
> That\'s it.
>
> DR. DWYER: Thank you very much. I think that is very helpful. Just
> wait one moment, so the committee can ask any questions and then we
> will let you go.
>
> Are there any questions from that? I think it got at some of our
> issues about what kinds of gloves and so forth. Any questions? Dr.
> Johnson has a question.
>
> DR. JOHNSON: Thank you, very much. You said, a couple of times\--in
> fact, you have a slide where it says, \"It has been shown,\" or, \"It
> has been demonstrated,\" that natural rubber latex has contaminated
> food that has been in contact with the gloves and caused adverse
> reactions.
>
> So what data did you use to support that statement because that seems
> to be an issue that we are dealing with.
>
> DR. TRUSCOTT: That which I am pulling from are the articles that you
> have already read and had before you, whether it be the orange juice
> or Dr. Beezhold\'s on the lettuce, but also the various reports that I
> have that you are going to be looking at would be\--Dr. Lise Borel is
> actually here having had reactions. Several people from the Potomac
> Group which is also here have sent in times that they have reacted to
> food that has been handled. Personal cases.
>
> DR. DWYER: That will be next witness, if that is any help.
>
> Dr. Hamilton?
>
> DR. HAMILTON: I would ask you to just remind me what the criteria\--I
> know you gave all the specifications for your medical-examination
> gloves for your company, but do you have any specifications for
> consumer gloves? I sort of missed that.
>
> DR. TRUSCOTT: Actually, what I was giving wasn\'t just for us. That is
> the general ASTM and FDA\--
>
> DR. HAMILTON: I understand that.
>
> DR. TRUSCOTT: Okay. For the medical food handling, it was just that
> that was read earlier; do not contain these chemicals, you are allowed
> to have this, basically, that is in the CFR.
>
> DR. HAMILTON: That is on the box?
>
> DR. TRUSCOTT: No; it is not on the box. If someone went to buy a glove
> right now from us, it does not say USDA approved because they don\'t
> do that anymore.
>
> DR. HAMILTON: Does it say, \"contains natural rubber latex,\" on your
> box?
>
> DR. TRUSCOTT: Yes.
>
> DR. DWYER: Anybody else? Dr. Gaspari?
>
> DR. GASPARI: I wanted to revisit what you said about rejection of
> medical gloves and being marketed, then, as food gloves. You said the
> commonest reasons are blemishes, the cuff is too short or problems
> with leaking. Revisit the protein situation again. Can your medical
> gloves be rejected because they would have too high a protein content?
>
> DR. TRUSCOTT: Yes.
>
> DR. GASPARI: And then they could be sold as a food-handler glove.
>
> DR. TRUSCOTT: Not for us. We have requirements for both. It can\'t
> leave the facility.
>
> DR. GASPARI: In other words, your gloves are never rejected because of
> the protein content?
>
> DR. TRUSCOTT: Yes; they are, but then they would either have to be
> rewashed or not used.
>
> DR. GASPARI: But is it possible that other vendors would have gloves
> that are rejected because of too high a protein content and then they
> could turn around and sell them\--
>
> DR. TRUSCOTT: Yes, because there are no rules out there for that. That
> is correct.
>
> DR. DWYER: Thank you, Dr. Gaspari.
>
> Dr. Fischer had a question, a final one.
>
> DR. FISCHER: Do you have a copy of your slides? Could we get a hold of
> that?
>
> DR. TRUSCOTT: We will get a copy of them. I will run it off. It is
> from a CDROM, so I will run that off.
>
> DR. FISCHER: I have a question. You had a whole list of chemicals that
> might be\--you had a list of chemicals that were associated with
> production and you said they might be on the glove at some point. Is
> this list just the chemicals that might be there or have they been
> found on the glove.
>
> DR. TRUSCOTT: They might be there. If someone uses surfactant, someone
> else may use a silicone derivative. So they will be different, a
> difference with different manufacturers. That is just on the surface
> and just part of the powder or the coagulant process, not the glove,
> itself, which has about 200 different chemicals.
>
> DR. FISCHER: I guess I am asking whether, other than the latex, the
> allergic proteins, or allergenic proteins, are there a slew of other
> chemicals that we need to think about being on the glove and possibly
> getting into people?
>
> DR. TRUSCOTT: Yes; and I guess, being quiet about it, that is part of
> what I am trying to underline, too, is how important the cleaning,
> washing, chlorination is to get rid of those types of things. However,
> do remember that these gloves are submitted to primary skin irritation
> and guinea-pig maximization for those two types of skin reactions,
> Type 4 in irritation.
>
> DR. FISCHER: Tell me why you chlorinate these gloves?
>
> DR. TRUSCOTT: We chlorinate because it hydrolizes so well all the
> surface. It does two things. It washes or gets rid of the protein and
> all the chemicals that are left over there and not bound\--not all of
> them, but the largest portion of them. If, then, the chlorine
> cross-links the surface so you actually have a less permeable surface
> to \"in and out,\" so it is usually better as far as reducing any
> hydration of the glove, itself.
>
> DR. FISCHER: Okay. Thank you.
>
> DR. TRUSCOTT: We do neutralize it so that is not free chlorine that
> running around.
>
> DR. DWYER: Thank you. Any other questions?
>
> DR. GASPARI: One last question. Any ASTM standards related to
> endotoxin content in medical gloves? Did you mention\--
>
> DR. TRUSCOTT: That is one of my big pet exciting things. Yes; we are
> right now developing those standards for surgical gloves, test
> methodology and requirements\--or I should say, with ASTM. It will be
> a voluntary standard, but the FDA is participating and may make it a
> requirement.
>
> DR. DWYER: Thank you. Thanks a lot, Dr. Truscott. You have clarified a
> number of points.
>
> Our next speaker will be Rochelle D. Spiker from the Potomac Latex
> Allergy Association. Ms. Spiker, thank you for coming and joining us
> and thank you for accommodating our schedule.
>
> **Public Comment**
>
> MS. SPIKER: Thank you. I am Rochelle Spiker, Executive Director of the
> Potomac Latex Allergy Association which is an education and support
> organization that talks to and interfaces with people not only in this
> area but around the country and even around the world.
>
> I don\'t think this is probably going to show up too well, but I have
> here a map of the United States. You might be able to see some of the
> states that I have colored in. These represent different people I have
> talked to over the past month about this particular meeting and about
> what type of experiences they have had having allergic reactions to
> latex gloves that have been used in food service.
>
> DR. DWYER: Ms. Spiker, just to help the committee see your visual, if
> you could give it to Mr. Scholz, he will take a look and pass it on,
> if you don\'t need it for your testimony.
>
> MS. SPIKER: Sure. These people are as diverse as a nurse in Alaska, a
> nurse in California, a writer in Florida, an artist in the State of
> Virginia, a respiratory therapist in the State of Maryland, a dental
> hygienist in the State of Wisconsin, a nurse and a teacher in New York
> State and a disabled mortician from D.C.
>
> All these people have reported to me allergic reactions. They bid you
> greetings. They would have loved to have been here if they could.
>
> Today, I have heard some amazing comments that are absolutely
> insulting to anyone who has this allergy which I wouldn\'t wish on my
> worst enemy. I think the worst comment I have heard is that fear is
> the problem and that is what is disabling people. I am also a
> licensed, certified social worker and the practicing psychotherapist
> in the State of Maryland and I will say that that statement about fear
> is baloney. That is a mild way to say it.
>
> If I was afraid, I wouldn\'t be standing here a block from the White
> House while we are at war. I dare so no one here is afraid either.
> People are aware that they need to avoid latex because most people,
> without even knowing about it, were exposed to latex in a restaurant
> or at a grocery store, had a bad reaction, could not fathom why this
> food that they had eaten for so long suddenly caused them a problem.
>
> Then, upon doing some research later, after they had been treated for
> that reaction, found out the problem was the latex, the latex gloves,
> that had been used to handle the food.
>
> I think that there is substantial evidence that latex gloves do cause
> allergic reactions in people who have latex allergy and who eat the
> food, and that goes back all the way to Dr. Schwartz.
>
> So I just want to make a few brief talking points here, the first
> being, because, after talking to a number of people, they wanted me to
> make sure I emphasized this. Latex gloves do cause allergic reactions.
> When latex gloves touch food and latex-sensitive eat that food, they
> can have an allergic reaction. That is the truth. That is what is
> going on.
>
> Latex gloves are sensitizing food-service workers who are wearing them
> to the extent that whole restaurants are saying, \"We don\'t use latex
> gloves anymore because too many people are allergic to them.\" That is
> going on out there. People who would like to avoid latex proteins
> cannot. These are people who are at high risk such as people with
> spina bifida because they don\'t know about whether their food is
> contaminated with these proteins or not unless they do a significant
> amount of research.
>
> Even then, it can get you. I have been to restaurants before where
> they said, \"Oh, no; we don\'t use latex gloves.\" But when you go and
> you see what they are doing, they do use latex. So it is out there.
>
> Gloves in food service tend to be powdered and cheap. They don\'t tend
> to be powder-free and low protein. Whatever is the cheapest is
> generally what food-service workers use. The issue with medical glove
> rejects has already been made, but definitely these are being used in
> food service.
>
> Food-service workers usually have knowledge about what gloves they
> use. I have asked them what kind of gloves they used. They had no
> idea. Furthermore, a lot of them did not speak English. Unfortunately,
> I have yet to see a NIOSH pamphlet or alert written in Spanish,
> despite the fact that Latinas or Latinos are the number-one ethnic
> group in this country and make up a high percentage of food-service
> workers in this area.
>
> What I have observed food-service workers doing with latex gloves is
> astounding including rubbing their noses, using them at the cash
> register and also using them to take out the trash. I have seen
> food-service workers wear gloves that looked filthy. So whatever type
> of education is going out there is not enough and I have doubts that
> any education is happening most of the time with food-service workers.
>
> Lastly, I would like to say this. Alternative gloves are available.
> Why don\'t we use them?
>
> I thank you.
>
> DR. DWYER: Would you mind just waiting a moment in case there are
> questions from our committee? Thank you, Ms. Spiker.
>
> Dr. Torres, did you have a question?
>
> DR. TORRES: I just wanted to ask how many members are there in your
> association, the Potomac Association?
>
> MS. SPIKER: I don\'t keep records on that sort of thing due to
> litigation issues.
>
> DR. DWYER: Anyone else over here have a question or a comment? Thank
> you very much, and we appreciate your coming in and sharing with us.
>
> MS. SPIKER: Thank you.
>
> DR. DWYER: I also am passing around comment from a Dr. Jacpor who is
> an M.D., M.P.H., from Riverside California. The next testimony we
> receive is going to be given by Dr. Lise Borel whom we heard from
> yesterday. But Dr. Jacpor is the actual person who Dr. Borel is going
> to be talking about. This letter from Dr. Jacpor describes her own
> travails as a latex-allergic individual.
>
> Dr. Borel.
>
> **Public Comment**
>
> DR. BOREL: Thank you. \"Dear members of the Food Advisory Committee. I
> am providing these written comments for presentation at the Food
> Advisory Committee Additives and Ingredients Subcommittee Meeting to
> be held August 26 through 28, 2003.
>
> \"The information I am sharing with you concerns my personal
> experience with severe asthmatic and/or anaphylactic reactions on
> multiple occasions after eating food that was handled with latex
> gloves. You may rest assured that this information is highly reliable
> scientifically, well documented through medical records and will be
> useful for your discussions.
>
> \"There is no doubt that food handled with powdered natural rubber
> latex gloves has the potential for causing severe allergic reactions
> in patients with Type 1 latex allergy. I am an
> obstetrician/gynecologist who was diagnosed with a severe Type 1 latex
> allergy in December, 1996. The diagnosis was based on a positive RAST
> test and a very strong clinical history and was later reconfirmed with
> a blinded controlled latex-inhalation challenge test with a 39 percent
> drop in FEV1.
>
> \"I have been evaluated by a number of well-known experts in the field
> of latex allergy including Dr. Loren Hunt, Dr. Kevin Kelly, Dr. Louis
> Roddy and Dr. Suhale Haval as well as others. I have been either
> admitted to the hospital or the ER or 37 occasions since October 26,
> 1996, for asthma, anaphylaxis, ventilatory insufficiency due to
> respiratory steroid myopathy as a result of steroid-dependent
> latex-induced occupational asthma and related complications.
>
> \"I have received 23 shots of epinephrin. In addition to the certainty
> of the diagnosis, because of my medical background, you may feel
> confident that I will not misuse medical terms. I received my M.D. and
> M.P.H. from the University of Michigan. I did two summer research
> fellowships at NIOD. I did my residency training at Harvard\'s Beth
> Israel Hospital. I have been a member of ASTM Consumer Rubber Products
> Committee D1140 dealing with these issues since 1997.
>
> \"In my case, my clinical history is not confounded with a large
> number of cross-reactive food allergies so it becomes obvious that the
> issue is the type of gloves with which the food was handled. I have
> undergone extensive testing for a large number of cross-reactive food
> allergies and all were negative with one exception, carrots, which
> were Class 2. I know not to eat carrots so carrots are not an issue
> during the following severe allergic reactions during eating.
>
> \"January 26, 1998. I went to hospital for a scheduled appointment
> with my allergist. Then I ate a prepackaged salad for lunch and went
> to an appointment with my PMR physician.\" That is her physical
> medicine physician. \"After lunch, there was a dramatic change in my
> condition. I experienced a very severe asthma attack. Initially, my
> peak flow was unmeasurable when I was taken back to the allergy
> clinic. I received vigorous emergency treatment with epinephrine, I.V.
> solumedrol and oxygen but still required transfer to the ER.
>
> \"After I was discharged from the ER that night, I worsened again
> after only a few hours and had to return to the hospital where I was
> kept longer. I later called the store that had prepared the
> prepackaged salad and was told they wear latex gloves. On several
> occasions, at that store, I had witnessed a woman wearing powdered
> natural rubber latex gloves while serving samples of food to
> customers.
>
> \"April 17, 1998. I experienced a sudden severe asthma attack and
> laryngeal edema after eating Muslix cereal. My peak flow went from 330
> to 100 when measurable. Epinephrine was required and I went to the ER.
> Later, I called Kelloggs and they told me that their Kelloggs workers
> don\'t wear latex gloves but the dried-fruit suppliers workers wore
> powdered latex gloves. My RAST test to almonds is negative. I have no
> problem eating Kelloggs cornflakes which has no dried fruits or nuts.
>
> \"November 26, 1998. During Thanksgiving dinner, just after eating a
> croissant, I suddenly developed acute respiratory distress, laryngeal
> edema, choking and vomiting. My peak flow fell from 390 to 130 when
> measurable. There was no latex-safe ER in that area so I treated
> myself with epinephrine, antihistamines and nebulized medication.
>
> \"The allergist called it a major anaphylactoid reaction. I have no
> known sulfite allergy; i.e., I have been able to eat things containing
> sulfites without reaction. My RAST test to celery and thyme were
> negative. When I called the bakery of the croissant, the Quality
> Assurance Department became defensive and refused to answer what types
> of gloves were worn.
>
> \"May 23, 2001. I experienced a severe asthma attack and G.I. distress
> at a relative\'s house after eating catered food which had been
> handled with powdered latex gloves. I had to take epinephrine and went
> to the ER. I learned of the latex contamination after the fact by
> calling the restaurant the next day.
>
> \"August, 2001. I developed asthma and angioedema around the eyes
> after eating some macadamia nuts. My RAST test to macadamia nuts is
> negative. Please see attached written confirmation that the packers of
> the macadamia nuts wear latex gloves in their facility.
>
> \"July 8, 2003. I had acute asthma after eating almonds. Then I
> recalled the earlier letter which stated that almonds and walnuts, in
> addition to macadamia nuts, were packed with latex gloves. My RAST
> test to almonds is negative.
>
> I have recounted for you the obvious examples. I believe there are
> probably several other occasions when I have had more minor reactions
> or I had difficulty pinpointing what happened. Clearly, natural rubber
> latex gloves should be banned from use in food handling. I know from
> extensive personal experience that eating food that has been handled
> with powdered latex gloves can cause a potentially life-threatening
> reaction.
>
> \"You already have medical literature which documents the transfer of
> latex allergen to food and subsequent reactions. I consider the loss
> of my health and career to be an unnecessary casualty as the result of
> a delay in government action.
>
> \"The first FDA meeting on latex allergy was held in 1992. I did not
> fall ill until late 1996, plenty of time for effective governmental
> action. At the very minimum, there should have been much more
> education and warning plus increased rinsing and leaching of latex
> gloves.
>
> \"I have been awaiting the publishing of the proposed FDA rule to
> limit protein levels in latex gloves for a couple of years, now. How
> many more unnecessary casualties will occur? This time, please make
> sure this is more than just another meeting. It is time for the Food
> Advisory Committee, the FDA, OSHA, the Consumer Product Safety
> Commission and other government agencies to take effective and
> decisive action on the issue of latex allergy and don\'t rely on ASTM
> to do your job of protecting the public with voluntary standards
> and/or guidelines.
>
> \"From what I have seen at ASTM meetings, ASTM appears to be a group
> of foxes guarding the chicken coop.
>
> \"Sincerely, Karen Jacpor, M.D., M.P.H.
>
> DR. DWYER: Thank you for presenting that testimony, Dr. Borel.
>
> Are there any questions? Nobody?
>
> DR. BOREL: Thank you.
>
> DR. DWYER: Thank you very much, Dr. Borel.
>
> Our last witness is Ms. Christine Andrews who is representing the
> National Restaurant Association. The committee is now receiving your
> handout but you will need to walk us through it because we haven\'t
> had a chance to read it.
>
> **Public Testimony**
>
> MS. ANDREWS: I will reading this almost verbatim except for some
> corrections for information that I learned yesterday on the statistics
> from FDA as far as the cases that they had.
>
> First of all, I would like to say hello and thank you for giving me
> this opportunity to speak today. My name is Christine Andrews and I am
> the Manager of Public Health and Safety for the National Restaurant
> Association. We would like to commend FDA for their efforts to solicit
> comments from industry and the public on the issue of latex allergies.
>
> The National Restaurant Association, founded in 1919, is the leading
> trade association for the restaurant industry. We represent more than
> 60,000 members and over 300,000 restaurant outlets in the United
> States. The restaurant industry employs over 11 million people and
> serves over 70 billion meals each year. As such, we have a vested
> interest in your discussions here today. Food safety is one of our top
> priorities so making sure there are multiple and effective barriers to
> prevent the hand contamination of foods is crucial.
>
> We need all the options available and more to prevent the hand
> contamination of foods. We do not support the elimination of any
> effective food-safety tools due to theoretical or unproven conjecture.
> If an effective food-safety tool is to be eliminated from the use in
> the restaurant industry, then there must be clear demonstrable science
> to support that removal over the potential negative implications for
> food safety. This is why it is imperative for the National Restaurant
> Association to respond to the inquiry that the use of latex gloves is
> a consumer safety issue.
>
> We believe, at this point, the that body of available scientific data
> or literature does not support the statements by some that there is an
> unacceptable consumer safety risk if foods are prepared using latex
> gloves. Dr. Beezhold\'s study, which attempted to make this
> correlation\--and I used the terminology in my written
> statement\--using poor methodology. We have discussed that at length
> about turning the glove inside-out and that is what I mean when I make
> that statement.
>
> But he also utilized an older generation of latex gloves which
> demonstrated much higher levels of latex proteins than those
> manufactured today. Additionally, it was not indicative of the normal
> food-preparation practices that you are going to see demonstrated in
> the food-service industry today or reflective of the advancement in
> latex-glove manufacturing.
>
> The technological advances established in the manufacturing of latex
> gloves today has greatly reduced the protein content of the latex
> gloves as well as the proteins that can potentially lead to
> sensitivity. Additionally, we do not believe that the modern
> food-handling practices have been appropriately reflected in order to
> make a conclusive correlation.
>
> Now, my next statement discusses vinyl versus latex and I do
> understand that this is not something that you are looking at. But
> studies have supported that the use of latex gloves provides far
> better protection against viral and bacterial transmission than those
> of vinyl which is commonly used for substitution in food service.
>
> In instances where glove usage may be required, and we have found that
> that may the be case, we would not want to prohibit the most reliable
> choice of gloves or would we want to provide only actions that may not
> pose the most effective barrier in the transmission of pathogens.
>
> Again, without more science to support that there is a risk to the
> consumer, it is premature for FDA to come to the conclusion that the
> latex gloves should not be used during food preparation because they
> pose a risk to the consumer. FDA has already made such a statement. At
> the Conference for Food Protection, which was held in Nashville in
> April of 2002, the FDA stated that 91 self-reported cases of
> food-mediated latex allergies from consumers were not clinically
> verified through medical records and it is impossible that some of the
> reactions described could have been due to consumption of foods that
> cross-react to latex protein.
>
> The conclusion coming from the Conference for Food Protection after
> hearing the recommendations from FDA was that there is a need for more
> studies on this topic due to the uncertainty regarding allergens being
> transferred and their effects to the consumer.
>
> In addition, as Doris mentioned when she spoke on behalf of Food
> Handler, NSF, a recognized leader in the development of standards for
> testing procedures for products in food, public health and safety, has
> recently established the first food service NSF disposable glove
> certification, The NSF Protocol 155. This certifications establishes
> criteria for product quality in terms of toxicology, physical
> properties, bioburden, barrier resistance and sanitation.
>
> This protocol was reviewed by a panel of experts including the
> National Restaurant Association Educational Foundation, the FDA, the
> CDC, the USDA, several state health departments as well as others. The
> scope of the protocol covers single-test gloves typically used for
> food handling, preparation and service tasks. This protocol also
> recognizes latex gloves as one of many options for use in food
> preparation in restaurants.
>
> With only suspect studies and without a confirmed clinical case of an
> individual experiencing an allergic reaction after eating food
> prepared with natural rubber latex gloves, we believe any conclusion
> is premature.
>
> At the same time, however, we do recognize that this issue can be a
> worker safety issue which falls under OSHA. As such, we believe that
> the only recommendation FDA can formulate at this point is that there
> is not sufficient data to make this claim or to take action. We
> believe that the FDA should recommend additional research to look at
> this issue more closely in the future to make a determination.
>
> Thank you.
>
> DR. DWYER: Thank you.
>
> Are there questions from the committee? Dr. Hamilton?
>
> **Questions of Clarification**
>
> DR. HAMILTON: Thank you, Mrs. Andrews. You made the statement that the
> levels of allergen in the gloves that Dr. Beezhold used was the old
> generation and that the newer gloves have lower levels of allergen. I
> am not aware of any study that has actually demonstrated that the
> gloves used in food handling are lower levels today than they were
> previously. Do you have any data that suggests that?
>
> MS. ANDREWS: Well, when talking on natural rubber latex gloves, we did
> talk with the Malaysian Council who did provide us with information
> that the technology that is used today in Malaysia and the standards
> that they have set in their gloves have demonstrated lower levels. I
> guess your question is, because there is no standard out there for
> food-service gloves, how I could make that statement. Is that your
> question?
>
> DR. HAMILTON: No. My question is, we know very clearly that medical
> gloves have changed. We have absolutely no knowledge about the
> consumer gloves that have been used in the food-handling business
> which are classified, in some cases, as rejects from medical-glove
> lines. Some cases, we have responsible manufacturers who apparently
> follow the same trends with medical gloves as they do with consumer
> gloves, but there are others that we know don\'t.
>
> So this statement really is not founded in fact. I caution you to make
> this kind of statement.
>
> MS. ANDREWS: I guess I should restate the statement to include that
> there are manufacturers out there who have utilized technology to
> lower the protein levels in current natural rubber latex gloves that
> are used today in food service. However, I would agree with you that
> is not across the board. There is not a standard set at this point and
> we would support a standard or something such as the NSF Protocol to
> bring all manufacturers to that level.
>
> DR. HAMILTON: Would you agree that we should design this strategy
> around the most conservative question which is that there are some
> gloves that are potentially hazardous being used in food handling and
> therefore, instead of focusing on a subset of gloves that may be
> clean, we have to also recognize that there are, or do exist or
> potentially can exist, gloves that have high levels of allergen as
> well. So this paragraph, I think, needs to be rewritten.
>
> MS. ANDREWS: Okay. I take your point. But did I clarify my statement
> better? Thank you.
>
> DR. DWYER: Could you tell us again. I am not sure I did hear that. You
> said the National Restaurant Association would support what?
>
> MS. ANDREWS: Just looking into this further, more research to look to
> see if this claim can be made and also we would support the NSF
> Protocol 155 or similar standards to address the issue once we have
> obtained adequate data to make the determination what may be
> appropriate to set the standard.
>
> DR. DWYER: You said you would support more research. Do you mean that
> you would approve of more research being done or does your trade
> association actually do research and fund research on this issue?
>
> MS. ANDREWS: No; we would recommend that research be done.
>
> DR. DWYER: Not that you would pay for it.
>
> MS. ANDREWS: Not that we would support it, fund it or spearhead it.
>
> DR. DWYER: Have you ever thought of doing some research because this
> is an area where there seem to be a lot of questions that are directly
> relevant to the industry, and with a war going on, government is
> hard-pressed to do it.
>
> MS. ANDREWS: At times in the past, research has been done coming out
> of the National Restaurant Association. It has been limited. When we
> discuss the various issues that we might have a stake in as well as
> our association may not have the funds to provide that type of
> research on their own behalf. But we have done research in the past
> for other issues.
>
> DR. DWYER: Thank you.
>
> Dr. Torres and then Dr. Blumberg and Dr. Gaspari.
>
> DR. TORRES: There have been questions about the lack of information
> also of the incidence of customers eating food that has been
> contaminated with natural rubber latex gloves. Does your association
> maintain any database of incidence that your members are experiencing?
>
> MS. ANDREWS: We do not have a database. We provide information to our
> members if they are asking for information on natural rubber latex
> gloves but we do not have an in-house data system to document if that
> situation has occurred by a member, one of our restaurant members, of
> maybe a consumer that has dined in their establishment. We don\'t have
> that data.
>
> DR. TORRES: How about your workers?
>
> MS. ANDREWS: We do not have that data. However, the restaurants will
> provide that data, as Marriott has spoke. We have risk-management
> sections within our corporations that do have that information and
> collect that, but we have not received that information and we do not
> hold it in an all-inclusive manner at our association.
>
> DR. TORRES: Has there been any discussion about this being an issue,
> claims, cost or anything like that at all?
>
> MS. ANDREWS: It is definitely an issue, as we can see that three
> states have banned the use of natural rubber latex in restaurants. We
> have worked with our states to educate them on what information is
> available. As far as it being a cost issue, we are not the ones that
> are manufacturing the gloves\--
>
> DR. TORRES: No; I am talking about the cost in terms of health costs,
> claims by your workers, compensation claims, anything like that. No
> database maintained?
>
> MS. ANDREWS: I don\'t have that information from our members.
>
> DR. DWYER: Dr. Blumberg?
>
> DR. BLUMBERG: With regard to NSF Protocol 155, you have the broad
> categories like toxicology and physical properties. Does that include
> guidelines for protein and powder content the way the ASTM has
> guidelines? Are you consistent with them or do you have those in it?
>
> MS. ANDREWS: Actually, Doris Rittenmeyer from Food Handler provided
> you with the protocol that includes that language. But, yes; those
> items are included in the protocol.
>
> DR. GASPARI: I had a question related to the statement about latex
> gloves providing far better protection against viral and bacterial
> transmission than those of vinyl. You said studies support this
> contention. Number one, we would be interested in the references and,
> number two, are these studies in the food-handling process or what is
> the scenario where the comparison between vinyl and latex has been
> studied?
>
> MS. ANDREWS: I actually I do not have that for you, but I will say
> that what Wava had presented in her presentation when she was looking
> at vinyl versus natural rubber latex and then nitrile and the
> transmission barrier. Those were the studies that I looked to when
> that statement was made. I believe she has provided that to you. I
> could do that, as well, but those were the same studies that I had
> referenced.
>
> DR. GASPARI: Can I ask you one other question about the restaurant
> industry serving over 70 billion meals a year.
>
> MS. ANDREWS: Yes.
>
> DR. GASPARI: Can you give me a little bit more information? How do you
> gather all that data?
>
> MS. ANDREWS: We actually have a research department in-house and we
> have a quick fax booklet that is distributed annually on behalf of our
> association and I can provide you with the details of that data. I do
> not have any with me, but we do have our own research department where
> you can verify how that research was conducted.
>
> DR. DWYER: Thank you.
>
> Dr. Hamilton?
>
> DR. HAMILTON: In your last paragraph, you state that, with only one
> suspect study without confirmed clinical case of any individual
> experiencing allergic reactions after eating foods. Could you describe
> for me what you consider a confirmed case. What criteria would you use
> to define a confirmed case?
>
> MS. ANDREWS: One that is clinically confirmed, that we hear testimony
> and we hear that there may be linkage between foods that have been
> eaten by a consumer but have they been clinically confirmed, number
> one, and, number two, has that correlation or has that link been made
> between the actual food that was consumed and the person that was
> having the individual reaction.
>
> When we are talking about stories of latex allergies that have
> occurred, we are talking about individuals that have dined in a
> restaurant and have had a reaction but that link has not been
> confirmed that that is where the actual reaction is coming from, from
> an actual food product that was prepared with natural rubber latex
> gloves.
>
> DR. HAMILTON: So you are asking for a challenge of the individuals, an
> actual formal challenge of the individuals, who have reported
> reactions after eating certain foods? Is that what you are asking?
>
> MS. ANDREWS: When we look at foodborne illness and when we work with
> FDA or look at data on documented foodborne-illness cases, we are
> looking at confirmed, cases that have been confirmed and documented in
> a clinical way. They are able to test the food. They are able to make
> a correlation and I guess there is a lack of that in what I have heard
> so far from individuals making claims that they have had a
> latex-allergy reaction due to consumption of the food product.
>
> DR. HAMILTON: So you are asking for double-blind, placebo-controlled,
> food challenge study.
>
> MS. ANDREWS: Since I am not a scientist, I am not sure if that is what
> I am asking for. But I am asking for something that is more concrete
> than personal stories that may be used as examples.
>
> DR. HAMILTON: Okay. The only suggestion I make is\--
>
> DR. DWYER: I think we need to go on to the next person and then we
> will come back to you.
>
> Dr. Downer?
>
> DR. DOWNER: Goulda Downer. In your second-to-last paragraph, you
> mention that you have recently established the first food-service
> disposable-glove certification and, as part of that Protocol 155, you
> mentioned that the bioburden was also established there. Can you
> explain what bioburden is within the context of what we are
> discussing?
>
> MS. ANDREWS: Sure. First of all, I am not sure, did you say that we
> established\--I just want to make it clear that I represent the
> National Restaurant Association and this Protocol is from the National
> Sanitation Foundation.
>
> DR. DOWNER: Okay.
>
> MS. ANDREWS: Bioburden is\--well, latex is a natural product and when
> you are looking environmentally at what we are putting out into the
> world when we are producing products, I believe that is what they were
> looking at with bioburden as a definition. Again, Doris has provided
> the entire protocol so I just gave brief talking points in my
> statement. So her protocol may actually better describe what is all
> encompassed when they talk about bioburden.
>
> DR. DOWNER: But it says here that the National Restaurant Association,
> you, reviewed it. But you are not sure?
>
> MS. ANDREWS: The Educational Foundation. We have the National
> Restaurant Association here in Washington, D.C. and we have the
> National Restaurant Association Educational Foundation who reviews,
> publishes and distributes educational materials. On various task
> forces, et cetera, the Educational Foundation will be the folks that
> actually sit on these panels and play an active role in the
> decision-making process.
>
> DR. DWYER: So you are saying that somebody at the Restaurant
> Association did it, but it wasn\'t you.
>
> MS. ANDREWS: It was definitely not me; yes.
>
> DR. DWYER: Fair enough.
>
> Back to Dr. Hamilton.
>
> DR. HAMILTON: What potential negative implications to food safety has
> the banning of latex gloves in the three states had on your industry?
>
> MS. ANDREWS: On food safety?
>
> DR. HAMILTON: Yes.
>
> MS. ANDREWS: As far as documented cases of foodborne-illness
> outbreaks?
>
> DR. HAMILTON: You say potential negative implications for food safety.
> I am saying\--
>
> MS. ANDREWS: When we are using\--latex-glove usage can be used as a
> barrier to prevent contamination of hands onto food products when
> preparing food. That is an option. It is an acceptable option at this
> point as well as we did talk about other options available to uses as
> barriers. However, we would not want to make a premature statement to
> eliminate\--say we need to eliminate the use of natural rubber latex
> as a barrier when we are talking about food safety when, right now, it
> is in place. It is widely used as well as others.
>
> So, until there is more information out there to provide that there is
> actually a danger, an increased risk to consumer safety, we would not
> want to eliminate that option for the restaurant to our food handler
> when they are preparing foods.
>
> DR. HAMILTON: But wouldn\'t you agree that the three states have
> sufficient evidence to suggest that the banning of a latex glove does
> not negatively impact on the implications of food safety? I mean, we
> have heard from three states.
>
> MS. ANDREWS: But those states have recently enacted the bans and we
> have not seen the data as far as what incidence\--the rates of
> foodborne illness in those states at this point to make that
> determination.
>
> DR. DWYER: Dr. Hamilton, I think if you check your slides, you will
> see that one ban started in March 2003. I don\'t know when Rhode
> Island started and we just tried to find out when Arizona started and
> we don\'t know. Maybe the gentleman from Arizona at 1:15 can tell us.
> August 2002? So we are talking nine months, so I think we are talking
> hypotheticals in terms of any kind of case finding, with all due
> respect.
>
> Are there other questions for the committee to ask our colleague from
> the National Restaurant Association? Thank you very much.
>
> MS. ANDREWS: Thank you.
>
> DR. DWYER: We are through everything except for our colleague from
> Arizona who will be on the telephone at 1:15. If you can try to get
> him a little bit earlier, that would be great because we really do
> have a great deal to do in a very short time.
>
> What I would like to do is reconvene at 1:10 so that we can review the
> charge again and then go right to this last witness. Then we will have
> about an hour and a half. Oh, excuse me. We have one more public
> comment. What I want is for them to call five minutes, at least,
> before these people are supposed to be on so the committee is not held
> up for another half hour while these phone arrangements are made.
>
> I\'m sorry. We thought we had gone all through the list. What is the
> name of the person? Ms. Yip from the Malaysian Rubber Export Company
> has asked to speak. This will be the last public comment between us
> and lunch.
>
> **Public Comment**
>
> DR. YIP: Good afternoon, ladies and gentlemen. I guess everybody is
> tired and that is why they have forgotten about me. First of all, I
> would like to thank you for giving me the opportunity to make a brief
> statement on the subject that is of much interest and that is consumer
> protection and food safety.
>
> As you may know, Malaysia is the largest medical-gloves exporter in
> the United States and we also manufacture and export food gloves. It
> is in that perspective that I would like to share two or three
> important points with you this morning.
>
> First of all, Malaysia, we would like you to know, has taken a very
> serious view of the latex-protein allergy concern and has made much
> effort to address it. You are aware that the latex allergy reported in
> the clinical setting is due to the use of an older generation of
> powdered latex gloves but has not control whatsoever of protein and
> powder levels.
>
> Through years of research on latex proteins and advances in
> manufacturing technologies, the protein content of latex gloves has
> been greatly reduced, as you have heard many times yesterday and
> today. Whereas the older generation of latex gloves, the protein
> content could be as high as more than 2000 micrograms per gram of
> glove. The present generation of latex gloves has protein levels as
> low as 50 micrograms per glove, especially in the case of the
> powder-free gloves.
>
> The use of these improved gloves has been shown to vastly reduce the
> incidence of latex sensitization as reported by seven independent
> recent hospital studies. Not only that, it has also showed that
> latex-sensitive workers wearing synthetic gloves can work side-by-side
> with their coworkers wearing these improved gloves and suffer no ill
> effects. In fact, I have attached a summary of all the references with
> the submission that I sent in earlier.
>
> With regard to latex allergy via food ingestion, it varies. No
> conclusive scientific evidence to support that there is an acceptable
> consumer-safety risk if foods are not handled by latex gloves.
>
> Recent studies have, in fact, suggested that the amount of protein
> transferred is very little into the food when you are using
> low-protein gloves. As the earlier speaker has quoted, at the
> Conference of the Food Protection held in Nashville last year, the FDA
> Center for Food Safety and Applied Nutrition stated in its paper that
> 75 self-reported cases of food-mediate latex allergies from consumers
> have been reported to them between late 2000 and early 2001.
>
> However, the cases reported were not clinically verified through
> medical records. Therefore, it is possible that the reactions they
> reported could be due to cross-reactive proteins from the foods they
> have taken. The conference concluded that there is much uncertainty
> about foodborne allergens being transmitted from latex gloves and
> their effects on consumers, and there is a need for more studies on
> this matter.
>
> My second point has actually something to do with the questions being
> raised this morning by Dr. Gaspari about the alternatives. The point
> is is food safety ensured if latex gloves are not used? Several
> studies by American scientists show that, without exception, the latex
> gloves are much more reliable than some of the alternatives in
> providing barrier protection against possible bacteria transmission
> from the hands of food handlers into food.
>
> The failure rate in barrier performance of vinyl gloves, for example,
> has been reported\--can be as high as 60 percent as compared to a few
> percent shown by latex gloves. The other synthetic gloves that are
> often used are the polyethylene. The studies also showed that the
> barrier performance of these gloves are even less reliable, often
> splitting at glove seams. There is also a list of references attached
> to me submission for your perusal.
>
> Furthermore, while there is a concern about leaching of proteins from
> latex gloves into food, one should be aware that the most commonly
> used vinyl gloves have been shown to leach a very toxic chemical DEHP
> into food. Studies have shown that DEHP causes a lot of adverse
> reaction in animal studies. For example, it is toxic to the heart, the
> kidney, the liver and the lungs and also affects the reproductive
> systems, particularly young developing males.
>
> Therefore, in July 2002, the FDA issued a Public Health Notification
> warning that \"In view of the available animal data, precautions
> should be taken to limit the exposure of the developing male to
> DEHP.\" You may also like to know that, because studies have shown
> that DEHP does leach into food from vinyl gloves, the Ministry of
> Health in Japan has already banned the use of vinyl gloves containing
> DEHP in food-service establishments.
>
> Finally, as gloves are used in the billions, as you have already
> heard, the impact on the environment is a matter of concern after they
> have been used, when you dispose them. In the case of latex gloves,
> they are very environmentally friendly. They are biodegradable and
> they are derived from renewable natural sources.
>
> Studies have also shown\--well, this is something aside from
> that\--have also shown that some 10 million hectares of rubber
> plantations worldwide can be moved. An estimated 363,000 tons of
> carbon dioxide from the earth\'s atmosphere and replace it with an
> estimated 264,000 tons of oxygen on a year basis helping, thereby, to
> counteract the greenhouse gas emissions and global warming.
>
> So, in conclusion, ladies and gentlemen, I would like to say that
> there is an insufficient and also inconclusive scientific data to
> claim that there is an acceptable consumer-safety risk if latex gloves
> are used in food handling. Taking into account of the latest
> development of glove technology, latex gloves actually present less of
> a health risk to consumers than many alternatives.
>
> Clearly, there is a need for many more studies for a better
> understanding of the problem.
>
> Thank you.
>
> DR. DWYER: Thank you.
>
> Let\'s just make sure there are not any questions. Do you use latex
> gloves in Kuala Lumpur?
>
> DR. YIP: Yes; of course.
>
> DR. DWYER: Any more questions? Dr. Hamilton.
>
> DR. HAMILTON: Hi. First, I want to applaud the whole Malaysian
> strategy for dealing with the issue of latex allergen. Do you have a
> global policy for all gloves coming out of Malaysia or just medical
> gloves coming out of Malaysia?
>
> DR. YIP: At the moment, we are doing the medical gloves; yes.
>
> DR. HAMILTON: So you have manufacturers who are producing consumer
> gloves, so to speak, that don\'t fall in the same framework.
>
> DR. YIP: No. But oftentimes the manufacturers produce medical gloves
> and they use the same line to produce gloves that are sold as consumer
> gloves. I mean, well, food gloves.
>
> DR. HAMILTON: But they are also manufacturing consumer gloves that
> don\'t\--
>
> DR. YIP: I don\'t think that there are any manufacturers that would
> actually\--
>
> DR. HAMILTON: I am asking the question. I don\'t know.
>
> DR. YIP: Sorry. The food gloves actually come from medical glove
> manufacturers, mostly. Not that I know of that there are any special
> food-glove manufacturers as such.
>
> DR. DWYER: Dr. Torres?
>
> DR. TORRES: I just want to have an idea. Can you tell me what is the
> breakdown on glove manufacturing? What percentage goes to medical and
> what percentage goes to food?
>
> DR. YIP: I see. Most of the gloves that are produced in Malaysia are
> for medical purposes. But there would be a lesser quantity of the
> gloves that are being sold as food gloves. I don\'t think there is any
> record as such in the sense of our production, but I do know\--well, I
> have gathered some statistics about the usage of food gloves in the
> U.S. You have about, what, \$95 million per year, U.S., per year,
> consumption of food gloves, as compared to about \$2.8 billion in U.S.
> That is a figure quoted in 2001.
>
> DR. DWYER: Are there other questions? Just a final one. What country
> produces most of the food gloves?
>
> DR. YIP: I do not think there is a record in that, but Malaysia is the
> world\'s largest medical-glove producer.
>
> DR. DWYER: We are more concerned, probably, with the others, but do
> you have a guess?
>
> DR. YIP: I don\'t want to give the wrong information.
>
> DR. DWYER: It is not Kuwait, is it? China?
>
> DR. YIP: China, yes. Thank you.
>
> DR. DWYER: Not Taiwan.
>
> DR. YIP: No, no. I don\'t think Taiwan is very active in that.
>
> DR. DWYER: Dr. Fischer and then I think we will be done.
>
> DR. FISCHER: Could you give us an idea about the incidence of latex
> allergy in Malaysia and among the workers, for example?
>
> DR. YIP: Right. You see, when the latex-allergy problem surfaced, we
> were very, very concerned because, you see, our people in Malaysia are
> exposed to latex and latex products every day, especially those that
> work\--those that tap rubber trees every morning, every day and those
> that work in latex-concentrate factories and latex-glove factories.
>
> What we did, we collaborated with Dr. Turjanmaa. We did studies,
> prevalence studies, of the rubber tappers, the latex-concentrate
> workers and the latex-glove workers as well as the hospital people,
> the general hospital. We found that the prevalence was very, very low.
> It was only about 2 percent.
>
> In fact, when we were doing the study, we were a little bored of the
> testing of so many people and there was no reaction, using the
> skin-prick test. The prevalence is really low. This has subsequently
> been confirmed by another study done by Don Savskin with the workers.
> The same low prevalence was reported. Also in the case by Thailand. A
> Thai study has been done, too, with their people and, again, the
> prevalence is very, very low, especially as compared to the 11 percent
> reported by the Canadian study some years ago.
>
> So inference would be that it is not a matter of just exposing
> yourself to latex every day, latex proteins, every day that would give
> you sensitization. I am not a medical doctor, but there is my
> thinking.
>
> You need to have something else; for example, a genetic buildup, some
> predisposition genetically that is required. That, in addition to
> repeat exposure, would do that job.
>
> DR. DWYER: Thank you very much. One more question, Dr. Hamilton.
>
> DR. HAMILTON: I just wanted to suggest that the mode of exposure in
> Malaysia for workers and the mode of exposure for the sensitized
> individuals that we see in the United States is radically different.
> So it can\'t really be compared directly.
>
> DR. DWYER: Are there any other questions over here? Anybody else over
> here?
>
> Then, thank you, Ms. Yip. We appreciate your contribution.
>
> DR. YIP: Thank you.
>
> DR. DWYER: We will adjourn for lunch and we will be back here sharp at
> 1:15.
>
> \[Whereupon, at 12:45 p.m., the proceedings were recessed, to
> reconvene at 1:15 p.m., this same day.\]
>
> [A F T E R N O O N]{.underline} [S E S S I O N]{.underline}
>
> \[1:25 p.m.\]
>
> DR. DWYER: Let me just cope with a little housekeeping here. We are
> grateful to the agency for supplying Dr. Breiteneder\'s papers that I
> have got right here. Dr. Johnson had to leave us because of her
> commitments as Dean at Vermont not allowing her to stay. But I have
> received some written comments from her that I will read into the
> record as soon as we start our discussion.
>
> At this juncture, are we about ready for our colleague in Arizona?
> Wonderful. Thank you very much. We can hear him now, I think.
>
> **Invited Comment from a State**
>
> **with Latex Food Service Glove Prohibition**
>
> MR. HARRINGTON: I am Don Harrington. I am the Food Safety and
> Environmental Services Manager for the Arizona Department of Health
> Services. I was requested to talk on this topic of how we prohibited
> latex-glove usage with food handlers within Arizona.
>
> So, if you will go to the first slide that begins, \"In the
> beginning.\" In the beginning, we had this 1976 Food Code as our
> official food code within Arizona. It was quite out of date, as I put
> in the slide. It was found lacking. It didn\'t relate to anything that
> was currently going on in food safety in terms of many of the
> risk-based factors that we now consider in food safety.
>
> So we opened up the rule package in order that we might try to modify
> that. We went through the process of trying, then, to adopt\--if you
> will go to the next slide\--the Arizona 1999 Food Code which is the
> U.S. Food and Drug Administration or U.S. Public Health Service Food
> Code, but we made some modifications to that.
>
> If you go to the next slide, then, the method that we go through to
> make these types of changes within Arizona involving forming a task
> force of regulatory, industry, academia and citizens to bring a
> collaborative and consensus approach to food-code adoption.
>
> If you will now go to the next slide.
>
> The comment period includes an oral proceeding in which interested
> parties can comment on proposed rule packages.
>
> And the next slide.
>
> In this particular case, we had really perfect timing for this concern
> to be brought to us. During the comment period of the Food and Drug
> Administration\'s rule adoption process for our \'99 Food Code, a
> citizen approached Senator John McCain\'s office vocally here in
> Arizona about latex allergies and wanted to know if there was any kind
> of possible legislation or rules that might be put into place within
> Arizona to deal with these things.
>
> Senator McCain\'s office then referred the citizen to the
> public-health agency in Arizona, which is our Arizona Department of
> Health Services which oversees the food regulation also within the
> state for retail purposes.
>
> If you will go to the next slide.
>
> Now, the comments that we received from her led us to then bring
> together a stakeholder group again so that we could get the same
> collaborative and consensus approach to putting this within our rule
> which, in our particular case, involved, again, the regulator
> community. It involved the Arizona Restaurant Association and academia
> and, of course, regular citizens throughout the state that were
> interested in the food-code rule. Consensus was achieved in adding the
> latex-glove prohibition. So we went back through the system one more
> time.
>
> In the second rule-package process, which is the next slide, please,
> the following comments received from the Arizona Department of Health
> Services modified the rule package to include latex provisions.
>
> So we received a number of comments, if you will go to the next slide,
> that were all in favor the latex ban. We received no negative comments
> about the ban whatsoever from any group, industry representative,
> regulatory community, none of any type.
>
> There were also some written comments received as well. We had some
> folks actually show up to our oral proceedings and they gave us some
> anecdotal information.
>
> If you will go to the next slide, the reasons for the prohibition were
> the comments that we received, as I just mentioned, an anecdotal
> nature described personal experiences involving food preparation and
> latex-allergy reactions. Also, during the time when we were putting
> all this information together, we came across, in the New England
> Journal, a commentary or a correspondence to the editor from a William
> Franklin, M.D., where he discussed the transfer of latex proteins in
> orange juice in a blind test. We also saw a latex-allergy article in
> the National Environmental Health Association Journal that had to do
> with cross-reactants but particularly where they talked about it being
> a public-health issue involving a significant number of people and the
> hypersensitivities that were being developed by medical workers and
> likely might be developed by other folks that might have consistent
> and persistent contact with latex.
>
> Also, there were proceedings from\--it was the Allergy, Asthma and
> Immunology proceedings from their annual conference that we also
> received information from where it discussed the transfer of latex
> proteins involving cheese and the handling by latex gloves.
>
> Those issues were our primary concern. Now, actually, we did have a
> two-fold purpose. To tell you any different would be totally correct.
> Our first purpose was, of course, trying to protect the public health
> and those individuals that were sensitized already and that were
> giving us the testimonies and things as to how they had had trouble
> with food that had been prepared with latex gloves, but our second
> reason, which was outside our regulatory authority, actually, was that
> we could see this was a consistent problem within the medical field.
>
> Knowing that there is a major movement within the food industry to
> have people wear gloves in the preparation of food and that it is the
> very strong public perception in today\'s world that wearing gloves is
> a more sanitary way of preparing food, many companies are going to
> policies where they institute glove use, we didn\'t want to sensitize
> a whole new group of workers.
>
> But, again, that was outside our regulatory authority and we really
> couldn\'t do it from that perspective. However, from the transfer of
> proteins and the ability to consider that, then, as an adulterant to
> food, it fell within our regulatory authority as we saw it.
>
> If you will go to the next slide; hence the responsibility that we
> feel that we have here in Arizona in our rule-making process and that
> the first priority is to be responsive to our citizens. The citizens
> were the ones who brought these concerns to us, not only the original
> person who went to Senator McCain\'s office, but also subsequent
> individuals that provided written information as well as testimony at
> the oral proceeding of their own personal nature.
>
> Within that responsiveness, also we have to act in behalf of public
> health, which we saw this as being consistent with, and we had to be
> diligent in examining all the evidence. Now, the evidence that we had
> was that there was a potential for this, if not an actuality of it,
> and then, also, the personal testimonies of the people that provided
> evidence to us and, then, also, to consider the costs and benefits to
> the stakeholders.
>
> We did an economic-impact survey on this and, at the time we did the
> economic-impact survey, we discovered in our rule that we listed in
> our rule package that, for disposable latex gloves, the cost per
> thousand was \$39.00 at that time. Disposable vinyl general-purpose
> gloves that had the same approximate dexterity and feel of the latex
> gloves were at \$41.00 per thousand, making a two-dollar difference
> per thousand gloves used.
>
> In light of the nominal nature of that, we received no kind of
> negative comments or anything from the industry groups nor the
> regulatory groups. Of course, we also looked into alternatives other
> the one to fit just exactly, much like the disposable polyethylene,
> the very loose-fitting baggy kind of gloves. They were at \$6.50 per
> thousand.
>
> Subsequent to us putting this within our rule package and prior to the
> rule actually being approved by our Governor\'s Regulatory Review
> Council, the cost of the gloves were actually given us to the that
> non-latex gloves had gone below the cost of latex gloves due to a
> number of manufacturing facilities being developed across the world
> and providing these gloves at the lower cost than actually the latex
> gloves were being provided at.
>
> We never actually got affirmative evidence or corresponding evidence
> that that was the case but, even with the two-dollar increase of the
> disposable vinyl gloves, the general-purpose-type gloves, the cost
> factor didn\'t seem forbidding in terms of the reaction by the
> industry representative who would be most likely to bear those types
> of costs.
>
> That pretty much concludes our whole process there. The next slide, if
> you will go to it, provides my current contact information if anybody
> at the meeting would like to have that or like to contact me further
> on this.
>
> Then the following slide gives my future contact information which is
> the reason why I can\'t be there today. We are in the process of
> moving from one location to another and I had to be here for that. So
> the last slide will provide you with that contact information.
>
> I guess the overriding principle on the entire process was the
> public-comment period. We feel very responsive here in Arizona and we
> try to have a very open dialogue with the citizens. We are very
> conscious of the fact that the citizens are the ones who pay our
> salaries and make our jobs possible. As such, we take it very strongly
> that we should be responsive to what they request and present them
> with as much information as possible and listen to their information.
> If we can honor their requests and stay true to the public-health
> mission, then that is our goal.
>
> I guess I am now ready to answer any questions, if there are any
> there.
>
> DR. DWYER: Thank you very much, Mr. Harrington.
>
> **Questions of Clarification**
>
> DR. DWYER: Dr. Gaspari has a question, and Dr. Torres. Dr. Gaspari
> will be first.
>
> DR. GASPARI: In your anecdotal reports that played a role in making
> your decision about this issue, were any of the reports related to
> allergic reactions in individuals where NRL carryover in the food was
> implicated?
>
> MR. HARRINGTON: Yes. On a couple of different ones that I can remember
> right off the top of my head. One was directly with the food handler
> where the person had a reaction and later went back and learned that
> the gloves were used within the food-handling process there.
>
> The second person, which was outside our regulatory authority but they
> gave us the information anyway, was in a more\--some of the powdered
> latex gloves were being used in this case and the powder got into the
> ventilation system and she was actually affecting sitting out in the
> restaurant before she ate anything, she had such a terrific
> sensitivity to latex that she received that.
>
> We informed her that that was outside the parameters of our written
> legal authority, we couldn\'t enforce ventilation from the perspective
> of any kind of air contaminants of that nature, in the restaurant. It
> might be under some kind of air-quality issue in the line down the
> road, but not within our food-code parameters.
>
> DR. GASPARI: In these cases, were the patients confirmed to be NRL
> allergic by RAST testing or skin testing or evaluated by an allergist?
>
> MR. HARRINGTON: They both knew they were. How they had determined
> that, I don\'t know. Both were healthcare workers who had developed
> the sensitivity in their communication with us through their job
> profession. We didn\'t ask them for any kind of medical records or
> anything to substantiate their claim.
>
> DR. DWYER: Dr. Torres?
>
> DR. TORRES: I think I already heard the answer but maybe I am going to
> ask the question more specifically. I am not familiar with the use of
> testimonial information by regulatory agencies in general, but I just
> was questioning whether there are any procedures to check the quality
> of the testimonials received since it seems to be playing such a
> strong role in some of the decisions.
>
> Are there any procedures to request to take a sample of the
> testimonial and request for medical records or some other supporting
> evidence or is it just the testimonial and no further request for
> information is given in general?
>
> MR. HARRINGTON: There hasn\'t been to this point. I would suspect that
> it might very well be the case and something that might involve more
> of an economic burden. That might have been brought up. The local
> industry group, there is a restaurant association, made no qualms
> about putting this into the rule and I think that is probably why
> those further evidentiary things were not considered.
>
> The people there that were talking to us and many that called us on
> the phone and everything depicted many medical conditions. One lady
> actually called me\--again, this is all anecdotal, of course\--she
> called me and she gave me a list of her doctors if I wanted to contact
> them. She gave me a list of local doctors and doctors that she had had
> across the country that have dealt with her, simply every aspect of
> her life, because she is so sensitive, I guess she had had to have
> surgeries, the way she described it to me. They had to order special
> tubing and everything else for her during surgery because she is so
> latex-sensitized that she can\'t have any kind of latex even in the
> operating room in any kind of capacity that might come in contact with
> her.
>
> DR. DWYER: Thank you, Mr. Harrington.
>
> Are there any other questions? Dr. Gaspari has another one.
>
> DR. GASPARI: You commented that you made some investigations into the
> cost of vinyl gloves versus latex gloves and you found there wasn\'t
> much of a cost difference. Does that mean if the vinyl gloves were
> prohibitively more expensive than the latex gloves that would have had
> an effect on your decision. Was that part of your process or had you
> made up your mind about your decision and your studying cost impact
> after the fact?
>
> MR. HARRINGTON: That is a great question. In this particular case, it
> didn\'t involve a great impact so there was really no need to pursue
> it further and industry, who would bear the cost, didn\'t have an
> objection at the cost difference. But, in the hypothetical case where
> there would have been a substantial cost difference to employ this new
> prohibition, I suspect the way we would have proceeded, and, again,
> this is hypothetical on my part, as well, but my guess is how we would
> have proceeded, we would have probably gone into more of the medical
> detail to see how many people were affected by this and what kind of
> costs would bear to industry if it would be a prohibitive type cost
> and have to weigh those measures together and try to bring\--again,
> Arizona is very much a consensus type state in rule-making and we
> would probably try to bring them the industry groups together and the
> anecdotal testimonial folks together and have them meet together to
> discuss all of these issues and present all this evidence and see if
> we could come to some resolution to where maybe industry would say in
> light of all of trial testimonial evidence, we agree, we will bear the
> costs and we will raise the price of our hamburger five cents or
> whatever.
>
> Or the people who want the ban might have said, well, I can understand
> how this would be so forbidding to industry that maybe if we could put
> signs up saying latex gloves are being used, there might have been
> some kind of compromise in a situation like that.
>
> I don\'t think we would have given up the public-health perspective
> because of cost but we might have tried to modify it so that there
> would have been an awareness made. But, again, that is all
> hypothetical. In this particular case, it wasn\'t an issue so it never
> got that far.
>
> DR. DWYER: Any other questions for Mr. Harrington?
>
> Thank you, Mr. Harrington, for taking time out of a very busy day to
> be with us at least by voice. We appreciate your testimony.
>
> MR. HARRINGTON: I appreciate the opportunity.
>
> DR. DWYER: Thank you very much.
>
> Any other comments or questions from the committee? I guess we are
> ready for the main chance, so to speak.
>
> **Committee Discussion**
>
> DR. DWYER: Let me suggest a way of proceeding and then ask for any
> modifications you wish. We have got three questions. We have got a
> little over two hours to answer them and so we will need to move
> quickly. The first question, obviously, has to be answered first
> because the other two are dependent on that.
>
> What I suggest we do is, first of all, focus down on exactly what, of
> all the things we have talked about, is the issue and we can ask, I
> think, if we need to, the agency people for clarification of the
> issue, but it should be on this page in your handout. It is very,
> very, very specific. It is not as broad as some of the testimony. It
> is basically the use of natural rubber latex gloves in retail food
> stores and the food-service industry.
>
> The focus of this is just whether it results in production of unsafe
> food, the gloves result in production of unsafe food. So that is what
> we have got to consider. That is what is meant by a food-mediated
> latex-allergic reaction from the use of these food-service gloves and
> establishments that make food.
>
> So the first question, what I will do is maybe start with Dr. Torres,
> go all the way around and see if we have got agreement, if there is
> any agreement, on the issue. If there is somebody who wants to speak
> to it to start off the discussion, but everyone will have to get on
> the record. If we can get to consensus, that is great. If we can\'t
> get to consensus, the record will reflect, in any event, each of the
> individual opinions of the group.
>
> Is there anyone who wants to start, or shall I just do it, starting
> with Dr. Torres. Dr. Torres, what is your view of the first question?
> Is there a positive relationship between the use of natural rubber
> latex gloves on food-service applications and allergic reactions to
> food that is served in these establishments or in the market based on
> what you have heard today?
>
> DR. TORRES: I feel that there was not sufficient evidence to show the
> relationship, particularly considering the number of people that have
> been affected by this use of the gloves. I am thinking about the 70
> billion number of meals served outside the home. When I look at the
> number of gloves used for food and compare them with the number of
> gloves that are used to treat patients, the number of the gloves that
> are used to treat patients is a much larger number. So the number of
> situations where there would have been a possibility to have some
> reactions is very small compared to the number of reported cases.
>
> So if there was such a strong relationship between the use of the
> natural rubber latex gloves, I would have expected a much larger
> number of even anecdotal evidence. Even that number seems to be small.
>
> That\'s it for now.
>
> DR. DWYER: Don\'t worry. You can chop in again.
>
> Dr. Hamilton?
>
> DR. HAMILTON: Hmmm. First, I would like to say that I think that there
> is conclusive evidence that allergenic proteins can be transferred
> onto foods. The study of Beezhold, barring all of the caveats of
> variables that could have been changed or looked at differently, I am
> convinced that allergenic protein can be transferred onto the surface
> of foods. So that is number one.
>
> Second, there are a couple of reports that lead me to the impression
> that the presence of latex allergen in a food can elicit a clinical
> symptom. Whether it is anaphylaxis or it is another allergic symptom,
> that is an issue that is rather softer. But the orange-juice study of
> Franklin, I thought, was a very interesting study. It is an n of 1. It
> is a very limited n of 1, but it was a double-blinded,
> placebo-controlled, study.
>
> They didn\'t measure allergen in the orange juice. They did have a
> control orange juice. So that gives me some indication that allergenic
> protein in a fluid that is consumed can induce a reported
> allergic-type reaction.
>
> The other studies, by and large, even the Castro study which looked at
> multiple levels of latex allergen put into sugar water, I can find a
> lot of technical concerns about it and potential flaws which make
> interpreting it difficult. So I am led to the notion that there is\--I
> am convinced that the presence of sufficient latex allergen in a
> solution that is consumed has the potential, and very well may be able
> to induce a reaction, but I would say that the relationship, the
> question asked about the positive relationship between latex allergen
> and food and allergic reactions, I would say this relationship is very
> weak in terms of the scientific peer-review data we have available.
>
> So I am right on the edge of answering that it is not a strong
> relationship but I am personally convinced that it can occur.
>
> DR. DWYER: Thank you.
>
> Dr. Taylor.
>
> DR. TAYLOR: I don\'t have a lot to add to Dr. Hamilton\'s comments. I
> think I am in complete agreement with him. I believe that a causative
> relationship has been established. I would certainly agree that we
> have reasonable evidence to conclude that natural rubber latex
> allergens can be transferred to foods from the same study that he
> quoted.
>
> I completely agree that the evidence is rather weak regarding whether
> those allergens can elicit reactions in sensitive individuals. There
> are a large number of unknowns. We don\'t know how many people might
> be at risk and we don\'t have very much information on how much
> allergen can be transferred under various conditions, and we don\'t
> have any really decent evidence on the threshold doses.
>
> But even with all of those uncertainties, I believe that, at some
> level, in some patients, that an adverse reaction could occur. So I
> would have to say that a positive relationship has been established
> although the strength of the relationship is far from strong.
>
> DR. DWYER: Thank you very much, Dr. Taylor
>
> Dr. Blumberg?
>
> DR. BLUMBERG: I am going to concur with the last two comments that I
> think, although it has been a very limited number of experiments, the
> evidence that allergens can be transferred from natural rubber latex
> gloves has clearly been demonstrated. The absence of any good
> information about what the eliciting dose, though, for an allergic
> response to be makes it very hard to begin to extrapolate whether, in
> fact, there is going to be a clinical significance to it.
>
> The orange-juice study certainly suggests that, again, it is possible
> to do it but there are all sorts of questions, then, about what the
> dose was and whether that was a realistic model to do so.
>
> So I think there is certainly suggestive evidence about a positive
> relationship between NRL gloves and allergic reactions, but, in terms
> of the strength of the scientific evidence to substantiate that, it
> falls along the weakest standards of scientific evidence with model
> systems that may or may not mimic real-life situations, studies that
> are of extraordinarily small size all the way down to just one
> subject. Even the larger studies with six subjects were not adequate
> for\--were actually not well controlled or were not adequate for any
> statistical analysis. We haven\'t seen that it any of the things.
>
> The case-series studies from the call-ins from the website I think
> certainly suggest that something is happening out there, but, again,
> it is in epidemiological standards of evidence that is the lowest
> level of standard. We have heard, certainly, in several of the
> testimonies that have been presented, some compelling testimony, some
> anecdotes, but, while anecdotes I think lead to the development of new
> hypotheses and suggestions about how to test it, anecdotal statements
> are not scientific evidence.
>
> I think I am just going to reiterate in saying it makes me believe
> something is really going on there, but, in terms of a scientific
> evaluation, anecdotal statements don\'t reach the level, even close to
> it, of providing proof. It is not to say it is not true. But if we are
> being asked by FDA here to evaluate the scientific evidence, lots of
> anecdotal stories still don\'t amount to that kind of factual
> examination.
>
> DR. DWYER: Thank you, Dr. Blumberg.
>
> Dr. Gaspari?
>
> DR. GASPARI: I pretty much agree with the last few speakers that I
> believe that it is plausible that NRL can be transferred from NRL
> gloves to foodstuffs and cause allergic reactions. I also agree that
> the scientific evidence is consistent with the possibility that this
> transfer can occur.
>
> I totally agree with the statement in terms of the anecdotal evidence
> that clearly it is suggestive that something is going on. It is weak
> evidence. The significance of the problem is unclear from the
> standpoint of the weakness of the anecdotal reports as well as having
> some idea of\--actually having no idea, actually, from any evidence
> whatsoever about the frequency of this occurrence in an at-risk
> population.
>
> So, really, it is a questionable link at this point, a very weak link,
> but I do believe it is plausible. I won\'t reiterate all the other
> points that were made which I think are valid.
>
> DR. DWYER: Thank you, Dr. Gaspari.
>
> We are on to Dr. Downer. I will read Dr. Johnson\'s comments at the
> end.
>
> DR. DOWNER: I concur with my colleagues that a positive relationship
> has been established since natural rubber latex can be transferred to
> food. However, the strength of the relationship is extremely weak.
> What we saw in the testimonies were mostly case studies that we read
> and anecdotal data but none of them provided enough scientific or
> rigorous studies to demonstrate that allergens transferred from food
> onto the gloves meets with current standards\--let me just go over
> that.
>
> There were mostly case studies and anecdotal data available, but not
> enough rigorous scientific studies to demonstrate that allergens
> transferred to food from gloves that currently meet scientific
> standards caused any allergenic reactions.
>
> As such, we were not able to decide on whether or not threshold limits
> were known, because we don\'t know that, both for sensitivity and
> reactivity.
>
> DR. DWYER: Thank you.
>
> Ms. Scholz, do you have any comments?
>
> MR. SCHOLZ: I would just add to that that there is obviously some
> relationship between the two. My sense is that it isn\'t strong but it
> certainly merits finding out more. I am also concerned that, before
> the FDA takes any action or would take any quick action, as some of
> the states have done, they have got to balance out the impact on food
> safety.
>
> It has taken us a long time to get to the point where we are today,
> either in restaurants or grocery stores or wholesalers\--it has taken
> a long time to get the food code that we have in the states that are
> implementing it. If we are going to start to back things out, I would
> be concerned. That is why I asked, I think, Rhode Island what they had
> done. By banning latex gloves, what other options retailers had.
>
> In Oregon, we heard that they are just requiring that they wash their
> hands a little bit more. So, if you are going to ban latex gloves in
> the industry, I don\'t know that grocers and restaurateurs and others
> would object as long as there is something to replace that with. They
> want to make sure that food is safe.
>
> We have heard all sorts of stories and concurred about nobody wants to
> have their restaurant where somebody keeled over. So, if we are going
> to do something, if the FDA is going to do something\--in other words,
> pull gloves out of the process\--then, from the retail side, we have
> to make sure that we are not sending any messages to consumers that we
> are not being careful.
>
> There is an expectation from the consumer\'s point. They expect to see
> those gloves on folks in the deli and in the bakery and in the
> restaurants. They believe that that is safety to them. If the message
> is that we are banning those gloves, we also have to have an equally
> strong message that says we are replacing it with vinyl gloves or
> plastic gloves or other steps to ensure food safety.
>
> I think it would be disastrous to not have that message there.
> Certainly, you need more work. I can\'t disagree with anybody here who
> said that we don\'t need to study it more. You do need to study it
> more. There is some relationship. I guess the question is is it strong
> enough to say we are going to pull latex gloves out of the entire
> food-service, food-retail, wholesale processor side because of the
> incidences that we have heard about today. It just needs more study.
>
> DR. DWYER: Thank you.
>
> Dr. Fischer. How did I miss you? Oh; you were not here. Okay. Sorry.
> We are just answering the first question.
>
> DR. FISCHER: We are on Question No. 1?
>
> DR. DWYER: Yes.
>
> DR. FISCHER: I think I will make it easy on everybody and simply say I
> completely agree with everything that has been said here. I believe
> there is a positive relationship between latex proteins and allergic
> reaction. Therefore, I believe that we can call the latex proteins a
> hazard, meaning that it has the potential to be a real problem.
>
> I agree with the words that indicate that we know nothing about how
> much it takes of the protein to cause the effect. It makes me think
> that\--it makes me doubtful that its appearance in food in what must
> be really low amounts compared to other modes of exposure is actually
> happening. So I am just not sure.
>
> And I agree that the data and the information we get from case
> histories is very weak scientifically although very compelling
> emotionally. I think some of the best we heard today in that letter
> from the physician in California. If that case history were published,
> it would be a contribution, at least to the literature.
>
> So, we are in agreement, it sounds like.
>
> DR. DWYER: Thank you.
>
> Let me now read Dr. Johnson\'s comments. She says, \"The evidence that
> food is contaminated with NRL proteins and that this leads to adverse
> consequences in NRL-allergic consumers appears to be based on, first
> of all, a small number of published single experimental trials, that
> paper where the physician in Boston did the stirring of the orange
> juice. Unfortunately, these trials did not definitively demonstrate
> that the food or beverage was actually contaminated with NRL.\"
>
> Second, she says that that data that she reviewed, \"seems to be based
> on consumer reports generated from a consumer-advocacy website for
> people with NRL allergies. The third source of data is anecdotal
> reports related to the committee in testimony and in the literature.\"
>
> She goes on to say that, \"This type of evidence is at the bottom of
> the scientific hierarchy for strength of the evidence and, hence, it
> is weak. Nevertheless, the case reports are compelling. It is
> important to note that there are data that NRL proteins are
> transmitted to food via contact with NRL gloves, at least
> experimentally.\"
>
> So that was what she concluded.
>
> I would agree that there is evidence that the transmission could
> conceivably occur and I agree that the strength of the evidence is
> exceeding weak.
>
> So it sounds like\--but let\'s open it up now for general comment\--it
> sounds like we are fairly in consensus about Question 1.
>
> DR. HAMILTON: Dr. Torres, you were sort of diverging from most of the
> other comments. Can you clarify your points?
>
> DR. TORRES: I was going to the end result. The end result is
> that\--there have to be events. One, there has to be transmission from
> the glove to the food and then that amount presented has to cause an
> effect. What I am saying is that I don\'t see any evidence of effect.
> Therefore, something before didn\'t happen and what appears to be the
> level is insufficient to cause an effect to be significant.
>
> DR. DWYER: How do the others feel about that? I guess the positive
> association that everybody seemed to agree on was evidence of
> transmission, transmission from the glove of these proteins
> to\--whether they are the right proteins or not, but certainly the
> proteins,
>
> Yes?
>
> DR. TAYLOR: I don\'t completely disagree with Dr. Torres\' comments
> because the experiments that lead you to have some proof that a causal
> relationship exists\--I described the orange juice experiment as
> contrived. It demonstrates that that level of latex proteins ingested
> by that patient provoke that reaction. But what it doesn\'t show is
> that, under some more typical method of orange-juice preparation that
> you would get a similar response because you might not get a similar
> transfer of allergen.
>
> The anecdotal reports seem to indicate that, under normal
> circumstances of food preparation, whatever I might mean by that, that
> people can have adverse reactions. But that has not been documented
> well at all in any kind of controlled clinical trials.
>
> So it hasn\'t been well documented that, under typical food processing
> or food-preparation practices, that sufficient quantities of natural
> rubber latex proteins can contaminate foods to cause reactions.
>
> DR. DWYER: As I understand it, there is evidence of transmission but
> then there needs to be evidence of an affect, an allergic reaction,
> and that is where Dr. Torres feels maybe the evidence isn\'t there and
> you agree with him; is that correct?
>
> DR. FISCHER: What I am convinced of is that there is a way to get
> enough latex in the foods to cause adverse reactions. Whether that
> happens on any kind of a reasonable basis in typical food-preparation
> practice I am less convinced of. But, then, the anecdotal reports lead
> me to think that there are enough of those that lead me to believe
> that that could very well be happening. But we certainly don\'t have
> rigorous scientific proof.
>
> DR. DWYER: Dr. Torres? Then I will go around.
>
> DR. TORRES: I would like to emphasize again the aspect of the numbers.
> The universe of events of this type of occurrences is huge. So if,
> under those huge numbers of events, we have seen such a few number of
> even anecdotal-type evidence suggests there is something strange.
>
> DR. DWYER: The argument is that there is a huge denominator and there
> are only a few cases in the numerator?
>
> Dr. Hamilton wanted to speak to that?
>
> DR. HAMILTON: To that point, the probability that a latex-allergic
> individual will enter into a restaurant that is using latex gloves is
> very low in comparison to the total number of events of individuals
> eating in restaurants that use latex gloves. So I think that your
> comment that the number of potential events is so large and we have
> only seen a small peak or a small number of reported cases, I think
> you are viewing the denominator in a different way than I am.
>
> I am viewing that the number of potential events of latex-allergic
> individuals entering into restaurants and being in the condition where
> they are eating foods that are a transfer of latex allergen is very
> small because you have got so many variables here.
>
> The person may be using a latex glove, but it may not be in contact
> with that particular plate that the individual eats. It is a
> probability thing. I think the probability that all these events will
> mold into a moment when that individual gets that plate of food that,
> in fact, was in contact with that glove in that right way is a very
> low probability. So I think the number of cases we have seen,
> anecdotal cases especially, would be consistent with my notion of the
> low probability of all these events happening, all these variables
> coming together at one time to basically provide the means for that
> individual to have a reaction.
>
> DR. TAYLOR: Besides, the question doesn\'t say anything about the
> frequency. It just says is there a positive relationship. Yes; there
> is\--very, very low frequency. I will buy that. But the question
> doesn\'t say anything about the frequency of the reactions.
>
> DR. GASPARI: But I would question, wouldn\'t the frequency influence
> how important a problem it is. If it is an extremely rare event, is
> that an acceptable risk versus if it is a more common event. I just
> raise that to the panel.
>
> DR. DWYER: Mr. Scholz, you had a comment?
>
> MR. SCHOLZ: Maybe this is better addressed in Question No. 3, but the
> number of incidences that could occur in the next year could decrease
> only because of growing greater public awareness, public education,
> the work of many of the outreach groups so that people are more aware
> of it. Especially if they find that they are allergic to latex, they
> are going to engage in avoidance of restaurants, grocery stores,
> anything where they may put themselves in that situation. That may
> even play to decreasing the number of occurrences that we have now.
>
> So let\'s just take the anecdotal stuff off the table. As the
> Restaurant Association was getting to, let\'s have some research. That
> is what we are going to use. We can\'t rely on what is going to happen
> in the general public even though they are compelling situations.
>
> DR. DWYER: That will be a question that comes up again in 2 and 3. But
> somebody has to pay the piper. It is well enough to say research, and
> the Restaurant Association says research and these other groups all
> say research, but the dollars for the research are necessary before
> the research gets done.
>
> Who else had a comment? Do we want to talk a little bit more about
> that second part of the evidence of an effect? Do you have anything
> over here? Dr. Downer, did you have any comments on the evidence of
> the effect? We talked about some positive evidence of transmission.
>
> DR. DOWNER: It says, if it exists, what is the strength of the
> relationship? I thought it was very weak and there is no cause and
> effect here. I didn\'t see any.
>
> DR. DWYER: Could we talk about that? You said no evidence of cause and
> effect in terms of the\--
>
> DR. DOWNER: What I am looking for is for those persons who are
> exposed, or who are sensitive, to NRL, can we say for sure\--for
> sure\--excluding food proteins\--that the food was not a confounding
> variable? How do we know\--so, if genetics did not play a role, I
> cannot prove cause and effect. I just can\'t. That was not at all\--I
> cannot say that there was cause and effect for this at all based on
> those two points.
>
> DR. DWYER: Dr. Gaspari, did you have a point on that?
>
> DR. GASPARI: The point that I would like to add is the strongest
> evidence would be you identify someone that is NRL allergic, his
> skin-test reactivity and positive RAST, goes to a restaurant and has
> an adverse reaction. Then you could actually study that food and
> demonstrate NRL contamination in that food and then, again, try and
> reproduce signs and symptoms with the levels that are detected in the
> food.
>
> I think that would be strongest evidence. Of course, we don\'t have
> anything close to that. We have no idea about the level of
> contamination of the food that is possibly causing these allergic
> reactions that we are seeing anecdotally.
>
> DR. DWYER: Back to the cause and effect on this side. Yes?
>
> DR. HAMILTON: I would like to make two comments. First, in terms of
> setting the bar for expectation, the technology is just emerging for
> us to measure, in vitro, the individual allergenic components down to
> an analytical sensitivity that we probably can get meaningful data
> from extraction from foods.
>
> But, if you remember the experience with our rubber-stopper studies
> where we had to actually go to intradermal skin testing to get
> sufficient sensitivity to detect the levels of allergen coming out of
> latex rubber stoppers into solutions that were causing systemic
> reactions.
>
> It tells that the in vitro methods may not be sufficient to detect
> levels of allergen and we may have to go to more sensitive methods
> such as in vivo skin testing. So we have to be very realistic that
> right now the technology for actually measuring allergenic material,
> allergenic content, is just emerging into real science.
>
> We have emerged out a total protein and total antigen into allergenic
> assays. The standards are beginning to emerge. The science is almost
> there. But we are not quite there, yet. So it doesn\'t surprise me we
> don\'t have that data for these existing studies.
>
> Now, could you reemphasize your point again, just what you said
> previously?
>
> DR. GASPARI: In other words, what I feel would be the strongest
> evidence that this phenomenon is actually occurring would be to follow
> an individual, an at-risk population, and really have a rapid response
> team, so to speak, that could jump in very quickly and analyze the
> patient and the circumstances where the carryover occurred and, in
> some ways, try and quantitate this carryover and reproduce that in a
> clinical controlled setting.
>
> Now, of course, that is the ideal world. With your technical
> background and experience, you are telling me that, while his may not
> be feasible, this is not difficult. I am not saying that this is kind
> of the best evidence repeatedly over a series of patients that would
> provide me with more convincing evidence that this is real. Is it
> possible, perhaps not at this point in terms of where we are with
> state-of-the-art in terms of measuring NRL in biologic materials.
>
> DR. HAMILTON: But you raised the key question which is what is the
> definitive study. You almost got to where I thought you were going to
> go.
>
> DR. GASPARI: Take me there.
>
> DR. HAMILTON: Which was double-blind, placebo-controlled food
> challenge, just like we have done with peanuts. Hugh Sampson is
> sitting up there in New York. He has been doing double-blind, placebo
> food challenges on children under controlled conditions. There is no
> reason why we couldn\'t take a population of latex individuals. Now,
> to get consent, and to get individuals participating, would be another
> issue.
>
> But that study could potentially be done without our ability to
> actually quantify accurately all the allergenic components in latex.
> The problem is that there are at least thirteen allergenic components
> of which some individuals make specific IgE to many of them and some
> to very few.
>
> So the allergen that we use for challenge is a key question. The
> variability and the sensitivity of the individuals would be a key
> question. So it becomes a very complicated study to document this
> issue from a double-blind, placebo-controlled, food-challenge
> approach. But I think that ultimately is the only way that we are
> going to get at this question.
>
> DR. DWYER: It is lucky that it is complicated, Dr. Hamilton. You will
> have a career that will flourish for many years.
>
> I think we have to work about not emerging science but the science
> that exists right now. We have to answer the questions with the
> science that exists right now, not the science that may exist in the
> future which will certainly be better than what we have today.
>
> So I am a little concerned about that whole issue of the cause and
> effect. I am not sure it is strong.
>
> Who else? Dr. Torres and then back to you.
>
> DR. TORRES: I think that your comments were more addressed to Item No.
> 3. I think, right now, it is not only the method whether they are
> available it is the data that is available. I don\'t care about the
> methods that are available. I care about the data that is available.
>
> With the methods, I don\'t know what we are going to find out, but I
> know that the data is not there. So the question is the data.
>
> DR. DWYER: What I was trying to say, and probably said badly, was we
> have the data that we have and we have the methods that we have. It
> may well be, in the future, there will be a method that could have
> taken the data we have now and made it better but, right now, we
> don\'t have that.
>
> Dr. Hamilton?
>
> DR. HAMILTON: I would like to\--again, in my initial comment, I said
> that the relationship is very, very weak. I support that whole notion
> that I feel we can\'t\--the data does not exist, just as we have heard
> from almost everyone, to conclusively demonstrate the presence of a
> certain level of allergenic latex in a food product when consumed by a
> variably sensitive individual, and that is another variable, will
> induce a systemic reaction. It just does not exist.
>
> We have to be honest with that fact. That is the fact. Now, do we base
> our decision for this first question on the absence of absolute
> scientific data or all of the data composite which would lead us to a
> general conclusion. I think that is the basic question. I don\'t have
> the answer to that question.
>
> DR. DWYER: Dr. Torres?
>
> DR. TORRES: I thought I was given instructions. The instruction
> specifically said, 409 or whatever the regulation, it had to be based
> on scientific data, scientific assessment, and nothing else but that.
>
> DR. DWYER: It has to be based on safety considerations, the scientific
> data with respect to safety.
>
> DR. GASPARI: Can I make a comment?
>
> DR. DWYER: Yes.
>
> DR. GASPARI: If it was a simple yes or no question and we had to
> answer from the standpoint either/or, we would all be responding as
> Dr. Torres responded that there is not ironclad proof in terms of the
> anecdotal data. But I gave a positive response in is it plausible. I
> think the answer is yes, it is plausible, without having the absolute
> convincing evidence.
>
> So we are in the grey area of where the evidence is and the evidence
> is on the anecdotal side and it is on the weak side, and we don\'t
> have all the pieces put together in that convincing set of experiments
> and allergic individuals. So that is where I am coming from and why I
> gave the response that I did.
>
> DR. DWYER: We haven\'t heard from Dr. Blumberg or Dr. Taylor, Fischer.
> Any comments over here?
>
> DR. BLUMBERG: I think I actually already did respond. I think it is
> useful to keep in mind that while, around this table, we may
> understand what we are saying but when we say the evidence is weak, we
> mean the standards of evidence in a scientific hierarchy from
> randomized controlled studies through anecdotal evidence. Again, that
> certainly contributes to the literature, especially that is published,
> but that the usual kinds of information that we judge in peer-reviewed
> journals of full articles\--most of this has been abstracts and
> letters to the editor and so on.
>
> At least certainly in my viewpoint, and what I believe everybody
> around the table is saying, is that the relevant data to answer the
> question is absent. We are not saying that this is both feasible and
> might be real, but that we don\'t have the data to say so.
>
> DR. DWYER: Thank you.
>
> DR. TAYLOR: Well, I already concluded that the data was very weak and
> I think everyone else said that, too. The strength of the relationship
> is not really there because the data is not really there.
>
> DR. DWYER: Dr. Fischer?
>
> DR. FISCHER: I think part of our differences which are very small, if
> they are there at all in terms of how we are thinking about it, maybe
> fits with our belief in case histories or anecdotal data as how
> important that is, or how unimportant it is.
>
> For me, if there were hundreds of case histories reported, then I
> would be more convinced than this just a few that we have had. Not to
> say that those individual reports are worthless, but altogether, if
> you added up lots of those reports, I think I would feel stronger,
> certainly, than I do looking at what we have now available.
>
> Maybe there are a lot of those reports out there waiting to be
> written, just like the one in California. But we don\'t have them.
> Question 1 says we have got to look at the data we have today, so that
> is where our problem is. We just simply don\'t have a lot of data and
> we probably place a different amount of weight slightly on the worth
> of those individual reports.
>
> DR. GASPARI: Could I amplify on something. I think it is important
> point. So there is a lot of data out there, and the data that we have
> looked at is very heterogeneous, too. So we have people responding to
> a website. We have case reports that are published in the literature.
> We have small numbers of patients that are challenged and they are
> challenged in different ways so there is not a lot of uniformity.
>
> So, basically, what I am getting at we need something to\--if we are
> forced to work at the anecdotal level, we need something better like a
> case definition or a set of rigorous criteria that we would accept as
> being a positive case as possibly being a transfer for NRL allergenic
> proteins that elicit a response.
>
> DR. DWYER: Thank you.
>
> Just for the record, my own view is that the totality of the evidence
> for establishing a cause and effect relationship between\--with actual
> allergic reactions in food, I view as weak, that cause-and-effect
> relationship. For me, anecdotal evidence, more anecdotal evidence, a
> thousand times as much anecdotal evidence, is not as compelling as
> more rigorous sorts of trials and experiments.
>
> I guess we have pretty much beaten ourselves to death on that first
> question. Shall we proceed to Questions 2 and 3 and which do you
> prefer to address? I guess we should go to 2 because we have said that
> a positive relationship exists even though the strength of the
> relationship is, perhaps, not as weak.
>
> So the question becomes, if a positive relationship has been
> established, and it has been shown to be causative\--and I guess there
> is some back-and-forth on that one. Can you suggest some science-based
> options to mitigate the food-mediate latex-allergy risk?
>
> So I guess, as we go around the table to discuss this one, the thing
> that would be most helpful to the agency is we have pretty much
> agreed, I think most of us, not, perhaps all of us, that a positive
> relationship exists. The issue is probably we still differ somewhat on
> the causation and probably also on the science-based options.
>
> So would that be an appropriate way to handle that?
>
> \[Inaudible comment from CFSAN\]
>
> DR. DWYER: Fair enough. Okay. So why don\'t we start over with Dr.
> Downer, if that is okay. Could you speak to that issue, your view on
> the causation and then your view on some science-based options to
> mitigate food-mediated latex-allergy risk.
>
> DR. DOWNER: Because there is no cause and effect\--we have a positive
> relationship but it has not shown to be causative. My suggestions
> were, and I think I sort of wrapped Question No. 2 and compiled No. 3
> with it, that we could support and encourage more opportunities for
> rigorous scientific studies and that the scientific studies that I
> would suggest would be double-blind, placebo-controlled, that would
> clearly demonstrate that the allergens that transfer to food from
> gloves cause these reactions. That is what we are looking for.
>
> So that would be my simple, quick response, something more scientific
> like double-blind, placebo-controlled. And what we are looking for is
> to say yes, we are going to deal in it or take out the food proteins,
> just go specifically to see, does the latex proteins or allergens, do
> they actually cause the allergic reactions.
>
> We would also want to look at dose response. One of the things we want
> to be able to find out from most of the research that we looked at and
> the papers and the presentations was somebody who was allergic to
> anything at all. We didn\'t know what dosage. We didn\'t know the
> duration. We didn\'t know any of those specifics and those are the
> things we would want to look for, how long did it take for them to
> become allergic or the reaction to be present, how much it took for
> them to present with the clinical symptoms.
>
> Also, we would definitely want to look at\--I would like for us to
> look at some of the genetic, the possible genetic, predispositions
> because what we are hearing is that it is not just the latex.
> Possibly, they were allergic to different kinds of things and other
> things.
>
> So I would like to tease those out and separate them so we get a clear
> picture of really is it the latex alone or is it in combination with
> other things.
>
> DR. DWYER: That\'s a lot.
>
> Dr. Gaspari?
>
> DR. GASPARI: I think I have already discussed this, what would be
> providing more convincing evidence that this phenomenon is real and it
> does occur, again, following high-risk patients and, when they have
> episodes, site visits and also detailed immunologic studies,
> placebo-controlled challenges, I think, would provide high-quality
> evidence. Also, the site visits from the standpoint is what about the
> gloves that are being used in the food-handers\' gloves and do they
> have a high protein content?
>
> Are all the episodes linked to powdered high-protein-content,
> poor-quality gloves or is it happening with medical-grade gloves. So
> those kinds of correlated information, assuming that even that there
> is a problem with quantitating carryover of NRL antigens into food,
> all of those correlative kinds of issues, I think, would
> epidemiologically provide if there is a common theme, a common
> scenario.
>
> Does the patient that experiences this reaction, does the patient
> react\--have IgE against all thirteen antigens. Is it a highly
> allergic patient or are they moderately allergic? These kinds of
> questions, an intense study of an individual who is a candidate for
> having experiencing this phenomenon and, again, along with site
> visits, would give us a lot of useful information.
>
> So those are some things that I think would be important. Other things
> that I think would help to mitigate the problem is, at this point, I
> am not ready to come out and make a strong statement that we need to
> ban latex gloves across the board, but just as we have heard
> discussions about patients that are peanut-allergic and they are
> provided the benefit of ingredient lists, that, perhaps, I will raise
> this as a point of discussion as well, is whether restaurants should
> be required to label themselves as latex-free or non-latex-free
> environments\--okay; latex-safe environments\--and have, again, a kind
> of global label for the NRL-allergic patient to make a decision
> whether they want to even go into a restaurant.
>
> Then the other thing, again, that came out of a number of the
> discussions was a closer look in possibly applying medical-grade ASTM
> standards to food-handlers gloves. So those are some of the ideas that
> I thought would potentially mitigate the problem.
>
> DR. DWYER: Could I just follow up on one question. You mentioned
> peanut allergy. It seems to me I read a case study, but I am sure Dr.
> Taylor or Dr. Hamilton or others know. This was a study I think where
> they were able to show that some of the people who had the worst
> peanut allergy were allergic, like, to four or five, three or four, of
> the proteins rather than just one or two.
>
> DR. TAYLOR: There are at least three major allergens in peanuts. I
> don\'t think there is any compelling evidence to suggest that most
> peanut-allergic people are sensitive to all three of those.
>
> There are a number of minor allergens in peanuts. There is some
> speculation on the part of some people including me that some of those
> are laboratory artifacts and not actual genuine allergens. So I don\'t
> think it would make much difference to a person\'s degree of
> sensitivity as to how many allergens they might be reactive to.
>
> You could be exquisitely sensitive to one latex allergen and be in
> just a big a risk as some guy that is allergic to all thirteen, I
> would think. It would be hard to put that all together.
>
> DR. DWYER: Dr. Hamilton?
>
> DR. HAMILTON: I would agree. In fact, if an individual had a specific
> immune response to Hev b 6 which is the predominant allergenic protein
> in latex, they would probably be at greater risk than if they had low
> levels to many of the other allergens.
>
> Our greatest, most sensitive, individuals are those individuals with
> atopic dermatitis that actually have developed specific IgE to all the
> allergens we can measure. At that point, it was eight allergens. Now,
> it is thirteen.
>
> DR. DWYER: Good. Thanks.
>
> DR. GASPARI: Perhaps the greatest role of detailed characterization of
> someone who experienced that would just, to get a handle on what the
> profile and, I gather, a cohort of the immunologic profile of someone
> that is, again, a candidate for this kind of reaction and whether they
> are uniform or whether they are heterogeneous, would just, again,
> perhaps, assist in risk assessment.
>
> DR. DWYER: Thank you. Could you just inform me of one other thing and
> that is do people who are latex-allergic have the kind of bracelets
> that people who are diabetic have? Is that a useful strategy, perhaps?
>
> \[Inaudible comment.\]
>
> DR. DWYER: Dr. Blumberg, give us your thoughts.
>
> DR. BLUMBERG: Just looking at the idea that we can look at options to
> mitigate food-mediated allergies, I mean, there clearly are two pretty
> obvious ones and they have been discussed. One is that you simply
> don\'t use the latex gloves and you avoid it that way. The other seems
> to be one that industry has been working on in any event which is to
> lower the amount of protein and the powder.
>
> Whether they are lowering it enough that it is going to have a
> difference, we don\'t know yet but that clearly is the other approach
> to alternatives. I think if we are looking at alternatives to the
> latex gloves, then I think, in a separate effort, you need to look at
> the efficacy and the safety of what those alternative might be.
>
> I certainly would concur with the comments that have already been said
> that another issue in this science-based approach is we need ways to
> better identify who are going to be the people who are sensitive to
> latex, whether they are obvious cases because they already have a
> latex allergy, or they don\'t know they have one yet and have had the
> eliciting dose but not a subsequent challenge.
>
> That would certainly be helpful. Although it doesn\'t directly address
> the question, I think it would certainly be useful to have information
> about the gloves that are used in food service. What we have certainly
> heard today is that some food-service workers have medical-examination
> gloves. Others have all variety of gloves and it seems that we don\'t
> even have a good handle about how many different kinds of gloves are
> available and what degree of the market uses what kind and if there is
> any specificity to different kinds of food-service workers using
> different types.
>
> It seems to be all over the map and just having some basic answers to
> those questions might be helpful in addressing approaches to solve the
> problem.
>
> DR. DWYER: Thank you.
>
> Dr. Taylor?
>
> DR. TAYLOR: Given the rather sad state of the science here, it is hard
> to come up with science-based options to mitigate the hazard. I
> emphasize \"science-based\" on purpose because I don\'t know that any
> of my suggestions will reach that standard of care.
>
> It is hard to separate Questions 2 and 3 entirely, as well, but I will
> do my best. I would like to make a suggestion that I think the Food
> and Drug Administration needs to do a better job of pursuing some of
> these case reports. Simply collecting them on some website that they
> don\'t have control over might not be the ideal way.
>
> They have this new care system that they seem to be pretty proud of. I
> would hope that the care system could somehow be aggressively used to
> identify some of these case reports but, furthermore, that they
> develop some sort of a questionnaire for their field staff so that
> they could actually go and pursue some of these cases.
>
> Just collecting the data will give you the thousand additional
> anecdotal cases that don\'t convince you much more than you are
> convinced today. They really need to get a questionnaire and then go
> visit the restaurants, go visit the patients, and see if they can
> figure out what some of the factors are that may be related to these
> cases because I think it would help to drive the research and maybe
> also to figure out how to best approach this from a regulatory
> perspective.
>
> I was struck by the fact that gloves used by consumers and
> food-service personnel seems to be a completely unregulated part of
> the industry. Certainly, it seems we can document that the medical
> gloves have been improved in quality leading to better occupational
> health and a better situation for the patients as well.
>
> But we know nothing about the gloves used in this industry and the
> protein levels and the degree of hazard and the amount of variability.
> It is always easy to sit here and say that we should do more research.
> Clearly, we should but, while we sit here and do research, affected
> consumers might be at risk of getting sick every time they go to a
> food-service facility or even to packaged-food facility as well.
>
> I would say that, even though I don\'t have enough evidence for this,
> a suggestion that adopting some sort of standard for the protein
> content of some other reasonable standard to control the quality of
> food-service gloves is a reasonable suggestion.
>
> I don\'t know that the NSF standard is the right one. I don\'t know
> how anybody could develop a standard based on the\--with the lack of
> data that we have now. But I am also not quite ready to go to the
> lengths that the three states have done and suggest that a total ban
> of latex gloves is warranted based on the evidence either.
>
> I think the medical industry has proven that you can use latex gloves
> in a reasonably safe manner and that the food industry shouldn\'t
> necessarily be held to a higher standard than that.
>
> Furthermore, I would say that whatever approaches the FDA might wish
> to take should be carried over to all levels of the food industry. We
> heard a lot about food service. That carries over into retail grocery
> stores, but I can certainly conceive of circumstances where the
> contamination could occur at an earlier stage in the food process. If
> there is a regulatory standard put in place, it ought to affect the
> whole industry, not just some segment of it that has been singled out
> for some reason.
>
> DR. DWYER: You are talking about the meat-processing further back or
> whatever it is processing?
>
> DR. TAYLOR: Yes. I would hesitate to set up standards for food-service
> gloves that then allow the packaged-food industry to go ahead and
> package the almonds or the lettuce or whatever it might be with
> poor-quality gloves. I am convinced if you give the guys who sell
> poor-quality gloves a market to sell them in, they are going to find
> it.
>
> So, if you don\'t want this in food, then you have to restrict the
> sales to a certain quality standard. It seems to me that some of the
> industry have very well demonstrated that they can reach those
> standards. The science isn\'t there to say that those standards are
> the right ones or that those standards are going to protect everybody
> all the time. Maybe much more relaxed standards might be okay. So I am
> less convinced I know enough about where to set the standards, but I
> think a completely unregulated industry puts these consumers at some
> degree of risk that the agency ought to be encouraged to take a faster
> look at that while they go about the more leisurely process of
> encouraging the research that is necessary to get a better handle on
> some of these issues.
>
> I would advocate on the research side, the double-blind,
> placebo-controlled, low-dose oral challenge is the way to go. You are
> going to find out what percentage of the latex-allergic population is
> at risk and at what doses they react. Admittedly, those kinds of
> studies are hard to do because I do them with peanuts and eggs and
> other things. But they are going to be really difficult to do for
> latex, but no worse than with some of the other materials. They can be
> done.
>
> DR. DWYER: I wanted to just mention and read into the record that
> there is an article here\--there are two articles that were given to
> us about the\--one of these articles is on clinical reactions or
> implications of cross-reactivity\--oh; this is food allergens.
>
> DR. TAYLOR: Yes; those are on cross-reactions. I would not encourage
> the FDA to be terribly concerned about the cross-reactions issue. When
> people have latex allergy, they need to be appropriately counseled by
> the clinician that they might be reactive to other foods where
> cross-reactions have been seen in a subset of those patients.
>
> But I don\'t know what the FDA could do about that in terms of any
> regulatory approach.
>
> DR. DWYER: Fair enough. I am interested in the research in that being
> done by NIH or by somebody else, to really clarify that.
>
> Dr. Hamilton, how about you?
>
> DR. HAMILTON: One of the advantages of coming later in the cycle is\--
>
> DR. DWYER: You are going to come first next time.
>
> DR. HAMILTON: All of the excellent comments have been made. I think I
> support\--I mean, every\--Dr. Downer, Dr. Gaspari, Dr. Taylor have all
> indicated a broad spectrum of excellent ideas. I would only suggest
> that, if I had a couple of million dollars, that we might be able to
> consider doing a few of those. So it is a cost issue.
>
> I especially wanted to support the notion that a segment of this glove
> industry is unrelated and any suggestion that we could actually reduce
> levels of allergen in gloves used for handling of food would have to
> be done by an overall regulation of gloves that are used in the total
> food-handling industry. So I support that notion very strongly.
>
> Again, I will go back to the notion that I can envision existing
> research centers doing controlled, double-blind, placebo-controlled
> food challenges by taking latex of calibrated levels and demonstrating
> the presence of food of allergenic levels on certain foods as inducing
> reactions. But that is a very complicated study that may be impossible
> to do in its definitive form with the rigor that we expect of science.
>
> It has been done with peanut because of the vast number of
> peanut-allergic cases that have been followed over many, many years
> and the fact that it is such a compelling issue of anaphylaxis whereas
> here we are dealing with morbidity as opposed to mortality as a
> primary issue.
>
> It is very difficult to recruit. I can tell you honestly we have a
> latex immunotherapy study right now and it has been very difficult to
> recruit to that.
>
> DR. TAYLOR: Let me give you an idea how you do this. You do this on
> people who are coming into the clinic to be diagnosed. It is hard to
> convince people that think they are going to get sick to do this study
> but if they might be latex allergic and they are presenting at the
> clinic on that basis, then you need to do a proper diagnosis anyway.
> For peanut, doing a double-blind, placebo-controlled food challenge is
> a reasonably decent idea. So you don\'t have the IRB concerns about
> the benefit to the patient because he is going to talk out with a
> competent diagnosis and a dose-response idea, too.
>
> DR. HAMILTON: But you are doing research. In our institution, that
> study would never fly without going through the Clinical Research
> Unit. Absolutely not.
>
> DR. DWYER: It is good to hear about Johns Hopkins.
>
> Do you have anything to say on that, Dr. Gaspari? I know you have done
> a lot of human studies.
>
> DR. GASPARI: I pretty much agree with what they said. I don\'t have
> anything to add.
>
> DR. DWYER: Fair enough
>
> How about you, Dr. Fischer?
>
> DR. FISCHER: Are we doing to do 2 and 3 together?
>
> DR. DWYER: No. We are going to do 3 as well because we have to get
> everything into the record. So if we can go one-by-one. The transcript
> will reflect everything because it is verbatim.
>
> DR. FISCHER: On Question No. 2, it suggests science-based options to
> mitigate food-mediated latex risk. I am AP, really, and that is
> anti-powder. I mean, I don\'t know why we have to contend with this
> powder stuff because it has been shown that the powder is a major
> portion of the problem\--maybe not the entire problem but a major
> portion. I don\'t know why we continue to use this powder.
>
> If it is hard to put these gloves on because there is no lubricant
> that you can whip them on and off fast, so what? Do it slower or have
> the industry come up with another lubricant or something to make it
> easier.
>
> So I think if we got rid of the powder we would get rid of a large
> portion of the exposures. That is what I have learned from listening
> for the last couple of days. It always comes up that way. So let\'s
> get rid of it. I think that would be a reasonable thing to do.
>
> When it comes to additional questions that need to be answered by
> research, I agree with Dr. Reed\'s comment about we don\'t know
> anything about the fate of the allergen, the protein allergens, in the
> gastrointestinal tract or in the body. We just really need some basic
> information about the stability in the GI tract and what happens to it
> and what tissues does it get to if it gets through intact and so on.
> Those kinds of studies could even be done in laboratory animals to get
> an idea of what is going on there.
>
> The technology is certainly not new to do that, so I think that ought
> to be done instead of guessing about what happens to the allergens in
> the tract, let\'s take a look at what happens to them and have an idea
> of what destruction or degradation of the dose occurs in the GI tract,
> because I have a feeling\--I guess that would be my hypothesis\--that,
> in fact, most of the antigen is destroyed in the GI tract so it may
> be, if you see anything at all in terms of foodborne allergen
> reactions to latex, it might be from a very low dose. Or maybe we
> don\'t see it because we can\'t get anywhere near that threshold dose.
>
> I presume all the double-blind studies and so on that everybody agreed
> upon are being done for at least one purpose and that is to understand
> the threshold, get an idea about the range of the thresholds, that are
> in people for exhibiting an allergic reaction. We need to know what
> that is.
>
> DR. DWYER: Thank you.
>
> Dr. Torres.
>
> DR. TORRES: At the danger of endangering my career potential for my
> colleague here, the first thing I would say that when one conducts
> research, one should conduct research in those high-risk situations.
> So I am not too prone to recommend much more science until we have a
> little more convincing evidence that we really have a problem.
>
> I think that we are at the verge of having a situation created for us,
> for FDA, by outside forces where the experiment is being conducted for
> us. We have three states where these gloves are going to be forbidden
> for use. One would expect that, if there was any evidence that gloves
> will solve some problem with those states, we are going to see some
> differences between incidence of latex in those states as compared to
> the rest of the nation.
>
> So that should not cost \$3 million to conduct. Maybe a \$50,000
> website or some contact information with the health agency in those
> three states and compare with another three states, do they see any
> difference. It has to be done in the future because we have two
> things; the states are doing something differently and the latex
> manufacturers are producing different gloves. So we have to monitor
> what is going on in time.
>
> I think that would be my recommendation for further research for the
> science to support\--maybe it is going to be anecdotal-type
> information that we don\'t like so much, but it will be at least a
> starting point to have a little more compelling reasons to do the more
> science-based research which costs a tremendous amount of dollars.
>
> The tremendous amount of dollars means something is not going to be
> done and that is a high risk.
>
> DR. DWYER: Thank you, Dr. Torres.
>
> Mr. Scholz?
>
> MR. SCHOLZ: I just want to follow up on the three states that you
> mentioned that they might be able to provide some evidence or some
> follow up. Just looking at the presentations and how the changes were
> made\--and correct me if I am wrong\--I didn\'t see a lot of
> science-based reason. It was all classic state legislative, let\'s put
> together a coalition, let\'s go knock on some doors, let\'s get an
> emotional moment and pass a law.
>
> That being the case, I also didn\'t see anything that would suggest
> the one of the things that they were going to do was to collect data
> and information based on these changes. If we are just looking at
> violations of the food code to see if, in Oregon, where it is wash
> your hands instead of wear gloves, food-code violations are going to
> take years to come together before somebody actually is going to have
> enough that they can say this is either working or not working.
>
> Even if you just look back on what it took to get to the current food
> code, that is decades of violations. So I don\'t hold out a lot of
> hope that what is going on those states is going to be able to help us
> drive to any conclusive points.
>
> DR. TORRES: I completely agree with you that the driving forces were
> political forces that some politician found it attractive as an issue
> and probably pushed it and that is why only three states.
>
> Oregon is a particularly interesting state because we do everything by
> voting. We vote on every single issue that you can imagine. It is a
> measure-based state, legislative action. So I agree with you. But we
> need to invest some money. I will say that FDA will have to invest
> some amount of funds, but it would not require the amount of funds
> required to do some of the science-based that has been suggested.
>
> So some kind of better questionnaires, maybe conduct the medical
> doctors doing allergy cases. I don\'t know. I don\'t know how to
> design that part. I am an engineer, so I don\'t do these kinds of
> studies.
>
> DR. DWYER: Let me just make some suggestions and then we will go to
> you, Dr. Hamilton. It seems to me from our experience, the hospital I
> work in was, until recently, associated with a hospital in Rhode
> Island so a lot of standards that they had filtered up to us in
> Massachusetts.
>
> I think there is a place for trying to keep the exposure as low as
> possible. Certainly, in the food service in the hospital, there is an
> increasing use of other kinds of gloves. I think some of it may have
> been spillover but it didn\'t seem to be onerous. The chefs could keep
> their gloves if they wanted, but, basically, it was trying to lower
> that. So the notion of latex-safe makes sense to me.
>
> The second thing I had the pleasure, for many years, to work with
> Lonnie Rosenwasser who is now at the Colorado\--I can\'t remember what
> it is called, National Center for\--National Jewish Hospital\--where
> they do a lot of these studies as others around the table do. I do
> think that some basic data on placebo-controlled studies would be
> extremely useful.
>
> The final thing is I think that industry needs to support some of this
> research because I don\'t think it is going to get done otherwise.
> Simply being crybabies and coming in, in whatever years it is that
> some regulations go in in twenty states, perhaps, is going to cost
> more in the end than it would be to find out the answers to some of
> these questions that are troublesome.
>
> Certainly, we disagree sometimes about the strength of the evidence
> and so forth, but the quality of the science that we were confronted
> with is, in my view, not good and any industry with any sense at all
> is going to try to bring better stuff to this not by trying to put
> pressure on government but also putting some of their own bucks in.
>
> Dr. Hamilton?
>
> DR. HAMILTON: Not having really presented a good suggestion but
> suggesting that others had and in listening to everyone, it has come
> to my thought that the most effective way of addressing this with the
> least expense is to basically eliminate the powdered latex glove. If
> you allow latex, at least allow the non-powdered latex glove
> which\--now, the caveats are, and we have known this since 1994 with
> John Yunginger\'s study, that not all powder-free latex gloves have
> low levels of allergen.
>
> But the majority of them have low levels or nondetectable levels. Even
> today, with the much tighter regulations, we have a better probability
> of getting gloves that essentially have no ability to transfer
> allergen onto anything that we can detect, because we can\'t extract
> it aqueous, in aqueous solutions, and detect it.
>
> So if there were to be one event that would be done, that could be
> done, that would be the least expensive and the most expeditious, it
> would be\--Dr. Fischer got it right\--and that is not powder. It is
> not the powder issue. It is the manufacturing process associated with
> the powder that really leads to the extractable allergenic protein.
>
> Having said that, Johns Hopkins came to the conclusion after making
> that decision that we could not guarantee the powder-free latex gloves
> didn\'t have high levels, occasional gloves coming into the
> institution, didn\'t have high levels. So we essentially banned from
> the institution all latex examination gloves and actually saved money
> in the process. Now, that was an irrelevant comment I made.
>
> But if there were an event that could be done where latex couldn\'t be
> eliminated from the code, by eliminating the presence of powder, that
> process of manufacturing the powdered latex glove, you will
> essentially eliminate the problem.
>
> I really refer to Dr. Tarlow\'s study, a number of very good
> controlled clinical studies in institutions that have suggested that
> going to a powder-free latex environment has essentially eliminated
> new\--minimized or eliminated new cases of latex allergy in those
> institutions.
>
> So the radical approach that we took at Hopkins may not be absolutely
> necessary if you were to go to the midpoint of getting rid of the
> powdered latex gloves. I know there is going to be resistance from a
> couple of manufacturers that have been pushing the issue of powder for
> years. Allegiance is the primary one.
>
> But the one event would eliminate the issue of transfer of allergen
> onto foods and, therefore, would make\--now, could you guarantee that,
> if food handlers were permitted to us latex gloves but non-powered
> latex gloves, that the occasional powdered latex glove will get into a
> food-handling institution or establishment? Well, there is no
> guarantee that they couldn\'t buy a powdered latex glove.
>
> But, by that one decision, you would essentially minimize, or in my
> opinion, minimize the issue to a 99 percent level.
>
> DR. DWYER: Thank you.
>
> Is the group of one mind on that issue that, at the very least, that
> should be done? In food-handling gloves, not in examination gloves. Is
> there a feeling of that? Shall I interpret silence as assent?
>
> DR. HAMILTON: Could I make the caveat that we really have to have
> definition of what powder-free means. I have obtained powder-free
> latex gloves that contain high levels of powder, that contain very
> sizeable levels of powder and those that contain no detectable powder.
> So the definition of powder-free is one that really should fall into
> the realm of the FDA\'s definition of powder-free, or less.
>
> DR. DWYER: So it is 2 micrograms or less? 2 milligrams or less.
>
> MR. HAN: It was established long ago 2 milligrams.
>
> DR. DWYER: If you would like to speak, please identify yourself and do
> so, but do so quickly.
>
> MR. HAN: Yes; I will do it maybe in three seconds.
>
> DR. DWYER: Good. We will count.
>
> MR. HAN: I am from the ASTM and the medical-glove examination is
> established together with FDA to have that standard. And that has been
> fixed as 2 milligrams for gloves. It is a number of years. But people
> still don\'t know that. That is available.
>
> DR. DWYER: Now we all know.
>
> DR. HAMILTON: Ko-Ki, we know that for medical gloves. But for
> food-handling gloves, that is not the case.
>
> MR. HAN: I know. You are now establishing food-service gloves to be
> medical type of glove. We have this discussion in the ASTM, the same
> thing.
>
> DR. DWYER: Good. Hurry and discuss it more. We beat you to it.
>
> DR. GASPARI: I have a question for the gentleman from ASTM.
>
> DR. DWYER: All right. Would you please come up again.
>
> DR. GASPARI: During the manufacturing process that results in a
> powder-free glove, do you then also see as another benefit of that a
> lowered total extractable protein or is that a further step to have a
> low protein powder-free glove?
>
> MR. HAN: No. I mean, the manufacturing process to go to powder-free
> has the advantage of more washing treatment and, thereby, reducing the
> powder to the minimum level.
>
> DR. GASPARI: But does that have any effect on the extractable protein
> content?
>
> MR. HAN: You are talking of extractable protein?
>
> DR. GASPARI: Does that give you a low-protein glove as well?
>
> MR. HAN: Oh, yes, in the powder-free usually less than 15 micrograms.
>
> DR. GASPARI: So, when we heard the earlier presentations about glove
> manufacturing, we heard that there is possible a lower incidence or
> prevalence of latex allergy declining over the last, say, five years
> and the two processes that, perhaps, were thought to be responsible
> for that were the low-protein and powder-free.
>
> MR. HAN: Yes.
>
> DR. GASPARI: So, are there additional steps beyond having a
> powder-free glove that you could further lower the protein to get you
> to that medical-grade glove just by lowering protein? Or are there
> additional steps beyond that?
>
> MR. HAN: Okay. My answer to you is that if you want to set a standard
> for food-service glove, set a powder-free with a protein level, with a
> protein level. If you set it without protein level, preferably taking
> the medical-glove one. This is what ASTM is doing, going towards that
> stage. But they have to be a medical-glove requirement. So I think, by
> doing so, you will be able to accommodate the needs of the industry, I
> mean good barrier properties and less protein.
>
> So I am connected with industry all the time because of\--and FDA and
> all that. We are one group that has everybody inclusive the advocacy
> people. So we have a lot of discussion, not simply come to conclusion
> of adopting a standard but is it economically viable? Is it cost
> benefit? All these things are\--
>
> DR. DWYER: We are addressing the safety issue. We thank you for
> addressing it.
>
> MR. HAN: Thank you very much for allowing me\--
>
> DR. DWYER: Yes. We enjoyed having your remarks.
>
> So we are talking about powder-free and we are also talking about
> protein?
>
> DR. HAMILTON: The protein is the key.
>
> DR. TAYLOR: I just want to comment that, in terms of that being a
> science-based recommendation, we didn\'t see any evidence of the rate
> of protein transfer from powder-free gloves on the foods. So that is
> an unknown. I am willing to accept that it is probably going to be
> lower, but that is an hypothesis. It is not yet proven.
>
> DR. HAMILTON: Can I just interject. I think Don Beezhold, in his
> study, does give us some data to actually support that concept because
> he did use powdered and powder-free latex gloves. As you saw just in
> the crude blots that he ran that the relative levels of allergenic
> material or protein that transferred were substantially lower.
>
> So there is at least a little bit of data in the literature.
>
> DR. DWYER: Dr. Torres?
>
> DR. TORRES: I was going to say exactly the same thing, that there was
> some data.
>
> DR. DWYER: Okay; fine.
>
> DR. GASPARI: The other piece of scientific evidence, then, is the
> dissemination of latex antigens to trigger respiratory attacks, so
> antigen dissemination, airborne dissemination. So there is
> precedent\--at least you could\--the role of powder in disseminating
> antigen.
>
> DR. DWYER: Very good. I am going to press on and try to get your first
> answers at 3:00 because one other member has to leave very shortly.
> But there is food back in the room if anybody wants to go and get it.
> There will be food there after we finish Question 3, too, and also
> beverages.
>
> Let\'s start with Dr. Taylor on Question 3 and finish this up.
>
> DR. TAYLOR: While I think I said that, to me, there is critical
> missing evidence here that is all subject to future research. I don\'t
> think we have a good idea of the number of people at risk from eating
> contaminated food. We have some idea of the number of people with
> latex allergy, but it seems that we have some preliminary evidence
> that perhaps not all of those people would be at risk of ingestion of
> latex through food.
>
> So I think, in terms of doing any kind of risk management, it is kind
> of important to know how many people are at risk. We don\'t understand
> very much about how much allergen is transferred to foods or whether
> they are differences between different kinds of foods and different
> kinds of gloves. Again, we are faced with preliminary evidence. I will
> put in a little plug for my colleague to the right, here, because
> probably hand-in-hand with that is the lack of suitable analytical
> methods to analyze for latex residues from actual food products.
>
> Then we don\'t have information on threshold doses, the lowest
> eliciting dose by mouth. I think if that study could somehow be done,
> it would really help reassure that you are at the right place in terms
> of these regulations. Even though we have heard a lot about anecdotal
> evidence of these reactions, we really don\'t have much of an
> understanding of the frequency of occurrence in the at-risk
> population.
>
> To me, if the FDA is going to enact regulations, it would be awfully
> nice to be able to document that the regulations were effective. One
> way of determining whether they were effective is whether the people
> that are at risk are having a lower frequency of occurrence of these
> reactions, whether you document all of them extraordinarily well or
> not.
>
> If these measures work, then these people should be able to eat with
> an enhanced measure of safety.
>
> DR. DWYER: Thanks, Steve.
>
> How about you, Jeff? Do you have some thoughts about Question 3?
>
> DR. BLUMBERG: I think there is a huge overlap between the questions
> asked in No. 2 and No. 3. It is hard not to just reiterate what some
> of those are. I think the issues about the amounts that are
> transferred from the glove to food, issues of bioavailability, issues
> of identifying at-risk individuals and the variations that account for
> that risk, whether it is genotype or phenotype, cross-reactivity to
> other allergens and so on.
>
> Finally, the idea that we need to test the hypothesis that, indeed,
> going to a medical-type glove, a powder-free glove, is, in fact, going
> to reduce the risk and be as good as, or as effective at reducing
> allergic responses, as just avoiding or maintaining a latex-safe
> environment, period.
>
> DR. DWYER: Thank you, Jeff.
>
> How about you, Tony?
>
> DR. GASPARI: I agree with the approaches that have been suggested. I
> am favoring a combination of epidemiologic research as well as in
> vitro laboratory methods. Of the two, I would recommend starting with
> epidemiologic approaches; in other words, following a cohort of
> high-risk patients and try and determine the number of episodes over a
> defined time period probably\--yes; a very ambitious study to do it
> right, it would probably need to be multicenter in a number of
> different allergy centers across the United States and find out if you
> could detect a defined number of events over a defined number of
> patient years.
>
> Then, attached to that is something that I mentioned a little bit
> earlier. If you do define events, then site visits would be critical
> to find the kinds of gloves that are used, to find the scenario where
> the episodes occur in that, if you find repeatedly a certain kind of
> glove and a certain kind of food stuff is linked to these episodes in
> restaurants, then that would guide the in vitro work in trying to
> determine NRL antigen carryover from a powdered glove to chicken salad
> or powdered glove to butter or powdered glove to whatever food stuff
> is in question.
>
> So I would take that approach and let the epidemiologic studies guide
> the in vitro methods. But I think the in vitro methods that have been
> described are absolutely essential. Of course, it is a field that is
> evolution, as Dr. Hamilton has already mentioned.
>
> DR. DWYER: Thank you. These are great ideas.
>
> How about you, Dr. Downer?
>
> DR. DOWNER: I concur with my colleagues. I guess I did answer that
> question. I confounded it to the other one which was No. 2. But I
> still think I would ask also abut the frequency of occurrence in that
> risk population. That is definite. And I would also look at antigenic
> cross-reactivity between rubber, again, and other plant allergens. I
> also think that is still a very important question that I would like
> to ask.
>
> DR. DWYER: Thank you. Mr. Scholz?
>
> MR. SCHOLZ: Just a couple of things. I want to just follow up on Dr.
> Hamilton\'s idea of why don\'t we just have a powder-free standard.
> Maybe what the FDA may want to consider is a pilot project with a
> chain of restaurants or a chain of grocery stores or food processors.
> It would be beyond me to suggest what you would do in that pilot from
> a science-based perspective, but it seems to me that, in the short
> run, it would be\--I don\'t know if it would be easy, but you
> certainly could enquire to see whether or not somebody would be
> willing to, over a period of time, just make that their standard in
> their places of business.
>
> The second thing I just wanted to mention is it would also seem to me
> that the FDA and HHS could play a significant role in a
> public-awareness and a greater education project. It doesn\'t cost a
> lot of money and, if Tommy Thompson can spend the time telling people
> they ought to eat less and trim up more and walk a little bit and
> smoke less, the power of that office and of the agency and its
> agencies within certainly has the power to heighten awareness amongst
> the public. I think that, in itself, goes a long way to at least
> making people aware.
>
> Finally, I just want to, again, deal with the domino effect of what we
> are doing and that is, if we are, in fact, going to change the
> standard, I would hope that the FDA would take some considerable time
> again to look at what those changes would do to the food code and to
> what the retail-food side has to do with food safety and what they
> have to do to ensure to their customers that nothing has changed, that
> the standard of what they have is exactly what it was the day before
> just because we are using a different pair of gloves, a set of gloves,
> or some other standard.
>
> DR. DWYER: Thank you. These are all good suggestions.
>
> Dr. Torres?
>
> DR. TORRES: When you are at the end of the table, you can all \"all of
> the above.\" There was one part of the presentation that I would like
> to have seen a little bit more. There were some questions, for
> example, what does the process do to the allergens in latex. I don\'t
> know whether time-temperature conditions and manufacturing of those
> gloves are all the same or there are maybe some differences between
> manufacturers and, therefore, you would have also some differences in
> the condition of that allergen after the treatment.
>
> The same for all the other processes and manufacturing; I have no idea
> how standard the processes are, whether other time-temperature
> conditions of drying those gloves would lead to less allergic
> reactions, I have no idea. I would like to look a little more at the
> manufacturing process.
>
> DR. DWYER: So, examine the manufacturing process, especially
> time-temp.
>
> DR. TORRES: Exactly.
>
> DR. DWYER: Very good.
>
> Dr. Fischer?
>
> DR. FISCHER: I agree with all of the comments made, except to say,
> again, that I would add to that studies on the fate of the antigenic
> proteins in the gastrointestinal tract.
>
> DR. DWYER: Thank you. That\'s good.
>
> Dr. Hamilton.
>
> DR. HAMILTON: The bitter end.
>
> DR. DWYER: Almost.
>
> DR. HAMILTON: Well, I have a list of about twelve ideas that came out
> just around the table. I like about 90 percent of them really a lot. I
> was thinking how one could actually design experiments to do these to
> get this information. I could list all of the points that have been
> made, but I won\'t, because they are in the record but I would go back
> to this one very practical potential way of addressing the issue which
> is I like the idea very much of trying to construct a pilot study to
> look at powder-free versus powder.
>
> In part, this has been done in hospital settings already, up in Canada
> primarily where they have been able to distinguish several
> populations. It is a very difficult study to do because it is very
> labor-intensive to go in and actually keep track of all the details
> and variables associated with these.
>
> But I like that idea to try and get some harder data, but I don\'t
> believe we will even arrive at peer-review-level quality data that
> could be published by doing a study of that nature. I think it will be
> very difficult to come up with conclusive data because we will have to
> have latex-allergic individuals actually go into these institutions.
> It is the probability of designing the study and the complexity.
>
> Finally, I like Dr. Gaspari\'s idea of beginning with epidemiology
> which is going to happen anyway because these patients have to be
> evaluated and could be monitored over time. If there were a registry
> or a network of working individuals that could work together, because
> the number of cases, as I feel, are beginning to diminish because the
> avoidance practices are improving in the United States, so this type
> of a study will become more and more difficult to do which would speak
> almost to the issue of well, is the problem going away.
>
> But I don\'t want to go there because I think that the problem still
> exists and it certainly exists for those individuals that are still
> sensitized.
>
> So I have really no substantial additional things to say except that
> the twelve points that have been raised by my colleagues here are
> excellent and I will just sit back and try and figure out how we can
> possibly do some of these research studies.
>
> DR. DWYER: Good.
>
> I will just say \"ditto.\" I think all of the ideas that I might have
> come up with are out and I do think an awareness effort is worth
> really looking at and getting some endpoints that are measurable to
> those awareness efforts.
>
> Dr. Downer.
>
> DR. DOWNER: Johanna, can you read Dr. Johnson\'s response, if you
> don\'t mind, to 2 and 3?
>
> DR. DWYER: Yes; sure. The answer to 2 is that, \"Prohibit the use of
> natural rubber latex gloves in food-service establishments.\" That was
> if we decided\--if the answer was yes. And then, \"Set standards for
> protein content of latex rubber gloves in food-service
> establishments.\"
>
> Her answer to 3 was that she also felt that clinical studies\--several
> people here said it\--\"clearly demonstrating allergic reactions in
> subjects known to have natural rubber latex allergies who have
> consumed a food or beverage that is known to be contaminated and you
> can measure the data on that contamination would be useful to do.\"
>
> So I think we have got her ideas in there.
>
> Any other ideas anywhere?
>
> DR. DOWNER: Thank you.
>
> DR. DWYER: Tell me, do we need to take formal votes? We don\'t, do we?
> It is all in the record.
>
> DR. TAYLOR: May I make one more comment?
>
> DR. DWYER: Of course.
>
> DR. TAYLOR: If the FDA decides to go forward and publish something in
> the Federal Register, I would really like to personally encourage them
> to add in the idea of taking natural rubber latex out of the
> chewing-gum-base regulations at the same time.
>
> DR. DWYER: Do we all agree that that is worth looking at? Is that a
> consensus? To regulate the gloves\--it just doesn\'t look right. It
> makes Tommy Thompson look bad.
>
> DR. TAYLOR: It is probably a frivolous activity because nobody is
> using it, but the simple fact that it is there is kind of an
> embarrassment.
>
> DR. DWYER: Take it out.
>
> DR. TORRES: I disagree. The reason I disagree is that if somebody is
> allergic to latex, they can go to the ingredient list of the chewing
> gum and decide whether to eat it or not. So it is a consumer\'s choice
> to eat it or not. In the case of the situation we are dealing with
> here is that the person attending to the McDonald\'s or whatever
> restaurant they are going, they don\'t have that choice. They don\'t
> know it.
>
> SO I think that is a big difference.
>
> DR. TAYLOR: I would agree if we were talking about peanuts. But we are
> talking about something here that I don\'t the industry even uses. So
> I am not sure you are going to have anybody advocating for the
> continuation of that particular application anyway.
>
> DR. DWYER: I think, at this point, we owe a great hand to Mr. Bonnette
> who has done such a good job in staffing this for us, and to our
> colleagues over here who are old hands at doing this. So we are
> grateful to the contractors who did the arrangements for us.
>
> It has been such a pleasure to meet some old friends from
> methylmercury. We do want to see that methylmercury recommendation
> because it has gone into some black hole and we can\'t get it. We need
> to see that one. We hope for Mr. Scholz that Wisconsin does better
> than its usual in its football.
>
> MR. SCHOLZ: We seem to have won a ball game last year. How about you?
>
> DR. DWYER: Very good. But thank you so much for bearing with us.
>
> DR. DOWNER: Johanna, on behalf of the committee, thank you for a good
> meeting.
>
> DR. DWYER: Great. We always have fun, don\'t we?
>
> \[Whereupon, at 3:30 p.m., the meeting was adjourned.\]