AT

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