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

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   S E S S I O N

[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.]