BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON EDUCATION AND

THE WORKFORCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

HEARING HELD IN WASHINGTON, DC, MARCH 25, 1999

Printed for the use of the Committee on Education

and the Workforce

Table of Contents *

OPENING STATEMENT, VICE-CHAIRMAN CHARLIE NORWOOD, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON EDUCATION AND THE WORKFORCE, U.S. HOUSE OF REPRESENTATIVES *

OPENING STATEMENT, MINORITY RANKING MEMBER TIM ROEMER, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON EDUCATION AND THE WORKFORCE, U.S. HOUSE OF REPRESENTATIVES *

STATEMENT OF DR. ANGELA PRESSON, MEDICAL OFFICER, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, WASHINGTON, D.C. *

STATEMENT OF ELIZABETH D. JACOBSON, PH.D. ACTING DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, WASHINGTON D.C. *

STATEMENT OF LAILENI KICKLIGHTER, ASSISTANT ADMINISTRATOR, RISK MANAGEMENT SERVICES, NORTH BROWARD HOSPITAL DISTRICT, FORT LAUDERDALE, FLORIDA, ON BEHALF OF THE AMERICAN HOSPITAL ASSOCIATION *

STATEMENT OF CHARLES E. REED, M.D., FORMER CHIEF, DIVISION OF ALLERGY AND INTERNAL MEDICINE, AND EMERITUS PROFESSOR OF MEDICINE, MAYO CLINIC, ROCHESTER, MINNESOTA *

STATEMENT OF S. TIMOTHY ROSE, PRESIDENT, AMERICAN DENTAL ASSOCIATION, WASHINGTON, D.C. *

STATEMENT OF F. SAMUEL EBERTS III, ASSOCIATE GENERAL COUNSEL, ALLEGIANCE HEALTHCARE CORPORATION, McGAW PARK, ILLINOIS *

STATEMENT ROBERT G. HAMILTON, PH.D., ASSOCIATE PROFESSOR OF MEDICINE AND PATHOLOGY, JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, ASTHMA AND ALLERGY CENTER, BALTIMORE, MARYLAND *

STATEMENT OF SUSAN Q. WILBURN, RN, SENIOR OCCUPATIONAL HEALTH AND SAFETY SPECIALIST, AMERICAN NURSES ASSOCIATION, WASHINGTON, D.C. *

STATEMENT OF C. EVERETT KOOP, M.D., FORMER UNITED STATES SURGEON GENERAL, WASHINGTON, D.C. *

APPENDIX A -- WRITTEN OPENING STATEMENT, VICE-CHAIRMAN CHARLIE NORWOOD, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON EDUCATION AND THE WORKFORCE, U.S. HOUSE OF REPRESENTATIVES *

 

APPENDIX B -- WRITTEN STATEMENT OF DR. ANGELA PRESSON, MEDICAL OFFICER, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, WASHINGTON, D.C. *

APPENDIX C -- WRITTEN STATEMENT OF ELIZABETH D. JACOBSON, PH.D., ACTING DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, WASHINGTON, D.C. *

APPENDIX D -- WRITTEN STATEMENT OF LAILENI KICKLIGHTER, ASSISTANT ADMINISTRATOR, RISK MANAGEMENT SERVICES, NORTH BROWARD HOSPITAL DISTRICT, FORT LAUDERDALE, FLORIDA, ON BEHALF OF THE AMERICAN HOSPITAL ASSOCIATION *

APPENDIX E -- WRITTEN STATEMENT OF CHARLES E. REED, M.D., FORMER CHIEF, DIVISION OF ALLERGY AND INTERNAL MEDICINE, AND EMERITUS PROFESSOR OF MEDICINE, MAYO CLINIC, ROCHESTER, MINNESOTA *

APPENDIX F -- WRITTEN STATEMENT OF S. TIMOTHY ROSE, PRESIDENT, AMERICAN DENTAL ASSOCIATION, WASHINGTON, D.C. *

APPENDIX G -- WRITTEN STATEMENT OF F. SAMUEL EBERTS III, ASSOCIATE GENERAL COUNSEL, ALLEGIANCE HEALTHCARE CORPORATION, McGAW PARK, ILLINOIS [ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD ON FILE WITH COMMITTEE ON EDUCATION AND THE WORKFORCE] *

APPENDIX H -- WRITTEN STATEMENT ROBERT G. HAMILTON, PH.D., ASSOCIATE PROFESSOR OF MEDICINE AND PATHOLOGY, JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, ASTHMA AND ALLERGY CENTER, BALTIMORE, MARYLAND *

APPENDIX I -- WRITTEN STATEMENT OF SUSAN Q. WILBURN, RN, SENIOR OCCUPATIONAL HEALTH AND SAFETY SPECIALIST, AMERICAN NURSES ASSOCIATION, WASHINGTON, D.C. [ADDITIONAL MATERIALS SUBMITTED FOR THE RECORD ON FILE WITH COMMITTEE ON EDUCATION AND THE WORKFORCE] *

APPENDIX J -- WRITTEN STATEMENT OF C. EVERETT KOOP, M.D., FORMER UNITED STATES SURGEON GENERAL, WASHINGTON, D.C. [COPY OF VIDEOTAPED TESTIMONY ON FILE WITH THE COMMITTEE ON EDUCATION AND THE WORKFORCE] *

APPENDIX K -- LETTER FROM MR. JOSEPH A. CARI, JR., UNGARETTI & HARRIS *

APPENDIX L -- ADDITIONAL MATERIALS SUBMITTED FOR THE RECORD BY THOSE CONCERNED WITH LATEX ALLERGY ON FILE WITH THE COMMITTEE ON EDUCATION AND THE WORKFORCE *

Table of Indexes *

HEARING ON LATEX ALLERGIES AND THE HEALTH

CARE INDUSTRY: DO OSHA'S ACTIONS CONFUSE OR

CLARIFY?

Thursday, March 25, 1999

The subcommittee met, pursuant to call, at 2:28 p.m., in Room 2261, Rayburn House Office Building, Hon. Charlie Norwood [vice chairman of the committee] presiding.

Present: Chairman Hoekstra, Vice-Chairman Norwood, Representatives Roemer, and Scott.

Mr. Norwood. A quorum being present, the Subcommittee on Oversight and Investigations will come to order.

According to Rule 12(b) of the committee rules, any oral opening statements at hearings are limited to the chairman and the ranking minority member. Therefore, if other members have opening statements, they will be included in the printed hearing record. This will allow us to hear from our witnesses sooner and to help members keep to their busy schedule.

Without objection, all members' statements and witnesses' written testimony will be included in the hearing record.

The subcommittee is meeting today to review the Occupational Safety and Health Administration's technical bulletin on natural rubber latex gloves and its usefulness to the health care industry. I would like to take a moment to welcome our witnesses. We appreciate your willingness to take time out of your busy schedules to testify before this subcommittee.

Managing latex sensitivities among health care workers and addressing the needs of latex-sensitive patients are key issues confronting the health care industry today. Today the Subcommittee on Oversight and Investigations will hear testimony on latex allergies in the health care industry and on action taken by the Occupational Safety and Health Administration. We will try to determine if OSHA's actions in this area confuse or clarify matters for health care workers and patients.

First of all, I want to again thank all of our witnesses for taking time from their schedules to spend some time with us here this afternoon to help enlighten us. We benefit greatly from your expertise, and I want to express my appreciation personally for your willingness to be here.

In addition, I understand that many individuals with latex allergies have taken time to call, write, and fax the subcommittee to share their knowledge and information on this issue. I appreciate your time and effort to educate us on the issues surrounding latex allergies.

We have a large panel of witnesses, and given the afternoon's start time for this hearing, I will keep my remarks brief so that we can begin with the testimony.

My focus for this hearing is not on whether or not latex allergy exists. Nor is it on the specific extent of latex sensitivity in the population or among health care workers. Those are important issues, but my concern today is primarily with OSHA's involvement in this issue and whether OSHA's draft technical bulletin helps or adds unhelpful confusion for health care providers who are trying their best to provide quality health care at affordable prices.

As many of you may know, before my election to Congress, I was a practicing dentist in the State of Georgia. So when I first learned of OSHA's activities in this area, I recalled that OSHA's bloodborne pathogens standard requires all dentists to wear gloves for all practical purposes during a routine dental examination. Latex gloves are considered effective and economical barriers for contagious diseases and in all likelihood are probably the most common gloves used in the dental field today. On the other hand, after reviewing various drafts of OSHA's documents, I was concerned that it seemed to advocate a position in favor of alternatives to latex gloves, such as powder-free or reduced-protein gloves.

My first question is, how do you define powder-free or reduced-protein gloves? The OSHA draft bulletin does not specify this information, so I wondered if it is helpful or unhelpful.

Secondly, I am concerned that OSHA's bulletin on latex gloves is not based on a careful, balanced review of the science. As I understand it, researchers and scientists are still gathering information on this issue, and there is no clear evidence that shows which risk reduction method is the best to reduce latex allergies in the workplace.

For that reason, the FDA has taken a cautious, measured approach to make sure that information about latex content is available for persons who might be latex sensitive. Yet OSHA's technical bulletin goes beyond FDA's approach and makes specific recommendations and does not seem to take into account either the uncertainties of the research on latex or questions of the safety of latex alternatives.

And third, the FDA has been working on solutions to latex allergies for over 10 years and is charged with regulating medical devices containing latex. I question whether OSHA should even be stepping into this arena. It seems to me that two Federal agencies regulating in this area without one advocating a particular position in favor of certain types of medical gloves would create confusion for the public.

I feel certain that this panel before us today will be able to offer some very thoughtful opinions. Again, I look forward to all of your testimony, and I very much appreciate your willingness to be with us today.

With that, I would like to now recognize my friend, Mr. Roemer, for an opening statement.

WRITTEN OPENING STATEMENT, VICE-CHAIRMAN CHARLIE NORWOOD, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON EDUCATION AND THE WORKFORCE, U.S. HOUSE OF REPRESENTATIVES SEE APPENDIX A

Mr. Roemer. Thank you, Mr. Chairman. I do want to say, before I even make my opening statement, that I enjoyed being with you over the weekend in an informal setting apart and away from Washington, D.C., in Hershey, Pennsylvania, to get a little bit better acquainted with you and our colleagues on both sides of the aisle. I hope we can bring at least some of that nonpartisan spirit and information seeking to this hearing here this morning.

Mr. Chairman, in that spirit, I would like to thank you for the opportunity we have today to discuss in a public forum a very emotional and serious issue. Latex allergies, without question, can devastate a person's life. Individual sufferers have in some instances had to quit their jobs and revert to lives of seclusion, always running a risk of coming into even the slightest contact with latex. Even the gloved hands of a paramedic seeking to provide aid could lead to potential coma or, in the worst instances, death.

However, the prevalence of allergies this severe in the general population is currently very small. it is very important that we understand the scientific evidence concerning this disability if we are to make informed decisions regarding potential Government guidelines on latex use in the workplace.

At issue today is OSHA's proposed non-regulatory technical information bulletin advising their local offices of potential hazards. This is not a new mandate coming out of the Department of Labor. It is a technical information bulletin that advises their employees of the current body of knowledge about latex allergies. I hope that our witnesses today are able to provide an informative discussion on any areas of contention that this bulletin may or may not have raised, or whether there have been some helpful areas that this has raised.

I know that we have many latex allergy sufferers in the audience today, including a 9-year-old, James Clark, who I had the opportunity to meet with earlier today. I am sure that James and his family and everyone else with a latex allergy share my interest and my concern in hearing this panel's testimony.

I thank the witnesses for coming today, and like the chairman in his opening statement, I look forward to a candid, honest, and nonpartisan discussion of these very important and critical issues. And I thank the distinguished chairman and look forward to our testimony.

Mr. Norwood. Thank you, Mr. Roemer. I appreciate that. I can't help but remark that we probably would have had a better time in Hershey if I could have kept from worrying about how many people are allergic to chocolate. When you are up there, just in the air it is everywhere, and that ought to be a consideration as well as gloves.

Mr. Roemer. I not only was there in the hotel, I toured the chocolate factory, Mr. Chairman, so it really would have been a problem.

Mr. Norwood. Now I will introduce our panel of witnesses. Our first witness today will be Dr. Angela Presson, a medical officer at the Department of Labor for the Occupational Safety and Health Administration.

Our second witness will be Dr. Elizabeth Jacobson, Acting Director for the Center for Devices and Radiological Health at the Food and Drug Administration.

Next will be Ms. Kicklighter, the assistant administrator for Risk Management Services at North Broward Hospital District, who will testify on behalf of the American Hospital Association.

Next we will hear from Dr. Charles Reed, the former chief of the Division of Allergy and Internal Medicine and an emeritus professor of medicine at Mayo Clinic.

Our fifth witness will be Dr. Tim Rose, the president of the American Dental Association.

Next will be Mr. Sam Eberts, the assistant general counsel for the Allegiance Healthcare Corporation.

Then we will hear from Dr. Robert Hamilton, an associate professor of medicine and pathology at St. John's University School. I am sorry, beg your pardon. You would not want me to mess that up, would you? I know. I mean from Johns Hopkins University School of Medicine, Asthma and Allergy Center.

The next witness will be Ms. Susan Wilburn, the senior occupational health and safety specialist for the American Nurses Association.

And, finally, we will hear testimony from Dr. C. Everett Koop, the former United States Surgeon General, who was unable to attend the hearing today, and will be providing his testimony by videotape, which we will be playing later.

Again, thank you all very much for being here.

Before the witnesses begin, I would like to remind the members that they will be allowed to ask questions of the witnesses after the entire panel has testified. In addition, Committee Rule 2 imposes a 5-minute limit on all questions.

Now, with that said, Dr. Presson, you may begin your testimony.

Dr. Presson. Thank you for the opportunity to testify about OSHA's efforts to address the serious occupational health hazards_

Mr. Norwood. Pull that microphone close to you. Try again.

Dr. Presson. Thank you for the opportunity to testify about OSHA's efforts to address the serious occupational health hazards associated with exposures to natural rubber latex. The use of these products may result in several types of reactions, which include localized redness, rash, nasal sinus, eye symptoms, asthmatic symptoms including cough, wheeze, shortness of breath, chest tightness, and rarely systemic reactions with swelling of the face, lips, and airways that may progress rapidly to shock and potentially, death.

Natural rubber latex is found in a variety of products used to provide health care as well as consumer products. Workers exposed to latex include those in latex glove manufacturing, electronics and drug manufacturing, and especially health care workers, who are exposed through the use of gloves.

Glove use in health care settings has risen dramatically since the mid-1980s due to the increased threat of contracting infectious agents such as HIV and the hepatitis B virus and the need for barrier protection. As glove use has increased, there has been a notable increase in reported latex allergy among health care workers.

OSHA's involvement with latex allergy began with our Occupational Exposure to Bloodborne Pathogens standard published in December of 1991. OSHA staff were aware that some health care workers had developed allergic reactions to latex gloves. Because the purpose of personal protective equipment is to protect the worker from a hazard, we were concerned that workers who might develop latex allergy would have no barrier protection if latex were the only glove material used at their workplace. Therefore, the OSHA standard included a requirement that alternatives be readily available to employees who are allergic to the gloves normally provided. FDA-cleared alternative glove materials including nitrile and vinyl.

Variations exist in the reported prevalence of latex allergy, probably due to different levels of exposure, as well as methods of estimating latex sensitization or allergy. Published prevalence studies indicate that approximately 6 to 17 percent of the exposed health care workforce is allergic to natural rubber latex, with a lower rate of 1 to 6 percent in the general population.

Most health care workers are able to use latex products without developing health problems, but OSHA has received numerous letters and phone calls from health care workers whose careers have been ruined and their lives forever changed by the onset of a latex allergy. In response to these concerns, OSHA has developed a technical information bulletin to assist our field staff in responding to questions and concerns of employers and workers. This bulletin is only advisory; it is not a new regulation or standard. Its purpose is to assure that our field staff members have accurate information on this issue. It will be sent to our field staff shortly.

OSHA has worked collaboratively with the FDA and other agencies in the Department of Health and Human Services to assure coordinated activities in addressing the health hazards associated with natural rubber latex. The current FDA regulation regarding latex allergy is limited to labeling. Thus, OSHA has not been precluded from activity regarding safe work practices or other protection for workers.

OSHA understands the need for coordination. We continue to work cooperatively and collaboratively with the FDA and other agencies. We circulated our draft technical information bulletin to FDA, CDC, NIOSH, and other stakeholders for comment. OSHA staff participated in a number of meetings and conferences with professionals at FDA and other agencies. Our physicians have observed the FDA laboratory procedures firsthand.

Last spring, the FDA spearheaded an educational outreach program on latex allergy, joining with OSHA, NIOSH, the CDC, the VA, NIH, and Consumer Product Safety Commission to sponsor a program on natural rubber latex allergy which was broadcast live by satellite. We were especially pleased to have as cosponsors our private sector partners, including the American Nurses Association, the American Dental Association, the American Hospital Association, and a number of glove manufacturers. Our partners helped secure program panelists and provided funding for the downlink sites across the U.S. After months of planning and cooperation, we delivered an interactive educational program to a nationwide audience at over 5,000 sites.

Last May, OSHA and NIOSH testified before the National Advisory Committee on Occupational Safety and Health regarding OSHA, NIOSH, and FDA collaboration in addressing latex allergy. NACOSH is an advisory committee established by the Occupational Safety and Health Act with management, labor, occupational safety and health professions, and the public represented. Committee members were impressed with the degree of collaboration between the three agencies and indicated that these cooperative activities could serve as a model for future projects.

In closing, natural rubber latex allergy is a serious occupational health concern. Appropriate actions are necessary to address this emerging hazard. Please be assured that OSHA has sought and will continue to seek to coordinate its efforts with other Government agencies.

Thank you again for the opportunity to testify, and I welcome any questions.

[The statement of Dr. Presson follows:]

WRITTEN STATEMENT OF DR. ANGELA PRESSON, MEDICAL OFFICER, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, UNITED STATES DEPARTMENT OF LABOR, WASHINGTON, D.C. -- SEE APPENDIX B

Mr. Norwood. Thank you, Ms. Presson. Ms. Jacobson.

Ms. Jacobson. Mr. Chairman and members of the subcommittee, my name is Liz Jacobson. I am Acting Director of the Center for Devices and Radiological Health at the Food and Drug Administration. I am happy to be here today to discuss the issue of natural rubber latex allergy and steps that the agency has taken to evaluate the magnitude and nature of the problem with respect to medical gloves.

FDA regulates surgical and patient examination gloves as medical devices. Both surgeons' gloves and patient examination gloves must be cleared by FDA before marketing. Most gloves on the market today are made of natural rubber latex, which provides good barrier protection against bloodborne pathogens.

The first reports to FDA of latex allergy date back to about 1989. FDA received reports of 15 deaths and numerous other severe allergic reactions associated with patient exposure to latex enema cuffs. Research done by FDA and others demonstrated that the latex proteins in such medical devices as enema cuffs and gloves can serve as allergens, and we began to advise manufacturers to reduce leachable proteins from their finished devices as early as 1991. We also issued an alert to the medical community telling them of the problem of latex allergy and requesting that they send us reports of adverse reactions.

Since the early 1990s, we have received over 2,000 adverse event reports describing allergic reactions to medical gloves containing natural rubber latex. These reports include reactions of patients and of health care workers and include 5 deaths in addition to the 15 associated with enema cuffs I mentioned earlier.

Scientific studies and case reports have documented sensitivity to latex proteins found in a wide range of medical devices. Based on this information, FDA required labeling statements on medical devices and device packaging containing latex, effective September of 1998. Labeling enables health care workers to make informed choices about the gloves and other products that they may come in contact with personally or use on patients who may have sensitivity to latex.

FDA also has significant concerns about the role of glove donning cornstarch powder in sensitization to natural latex proteins. Latex proteins have been shown to bind to cornstarch, and laboratory testing has shown that sensitized individuals can react to these proteins when the powder is inhaled. Airborne glove powder carrying latex proteins may be a significant agent for sensitizing individuals who breathe in the powder. We believe that decreasing the levels of glove powder can help control the problem.

Although natural rubber latex is recognized currently as an excellent overall material for barrier protection in health care settings, the use of powder as a lubricant in glove donning is widespread. Recognition of the existence of latex allergies in patients and health care workers and the concern that powder may play a role in increasing sensitivity to latex are making alternative technologies more attractive and stimulating research into alternatives. Some health care institutions already have discontinued use of latex gloves in favor of synthetic rubbers or other synthetic polymers. Alternative manufacturing processes exist. For example, chlorination of natural rubber latex gloves can eliminate the need for donning powders.

It should be stressed that alternatives to powdered latex gloves are cleared by FDA only if they are as safe and effective for their intended use as other products on the market. The use of such products for protection against bloodborne pathogens remains the primary concern.

Since the problem of latex allergy emerged, FDA has undertaken numerous activities to understand and address this problem, including educational workshops, conferences, research method development on measuring latex protein, providing guidance to manufacturers, and a labeling regulation to require disclosure of the presence of latex in medical devices.

We are continuing these efforts and are also considering additional regulatory options such as further labeling requirements and recommending maximum amounts of natural latex protein and glove powder on gloves. We have, and will continue to collaborate with, other Federal agencies such as CDC and OSHA in our activities.

Recently, concerns have arisen that OSHA's draft technical information bulletin may conflict with FDA regulations and infringe upon FDA's regulatory jurisdiction over natural rubber latex gloves. We do not believe the recommendations contained in the draft bulletin conflict with FDA regulation. Further, FDA has been an active participant as the bulletin has been developed. FDA intends to focus its regulatory activities on aspects pertaining to the products themselves, such as labeling requirements to assure safe and effective use and on effective barrier properties. We defer workplace controls to OSHA and have not preempted OSHA's regulation in the workplace.

I thank you for the opportunity to appear here today, and I will be glad to try to answer any questions you may have.

[The statement of Ms. Jacobson follows:]

WRITTEN STATEMENT OF ELIZABETH D. JACOBSON, PH.D., ACTING DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, WASHINGTON, D.C. -- SEE APPENDIX C

Mr. Norwood. Thank you, Ms. Jacobson. Ms. Kicklighter.

Ms. Kicklighter. Yes, sir. Thank you, Mr. Chairman. I am Laileni Kicklighter, assistant administrator of Risk Management Services at the North Broward Hospital District in Fort Lauderdale. I am also the immediate past president of the American Society for Healthcare Risk Management, which is a personal membership group of the American Hospital Association.

Risk managers identify and investigate patient and health care employee injuries. I am also a nurse with considerable experience in infection control. I am here today to represent the American Hospital Association.

Many health care professionals believe that latex gloves are the most effective at barrier protection, preventing potentially deadly viruses and harmful bacteria from coming in contact with the skin. This, combined with the availability, manual dexterity, and affordability, has made latex gloves the standard in the field.

But as their use has grown, so has our awareness of latex allergies. Safeguarding the health and safety of all workers and patients is a profound responsibility and one our members take very seriously. To fulfill that responsibility, hospitals and health systems are working to reduce the risk of exposure for those who are allergic to latex. This includes evaluating and managing personnel with a latex allergy, establishing methods to watch for latex reactions, purchasing gloves according to barrier effectiveness and worker acceptance, and measuring the impact of preventive measures.

The AHA has provided guidance to hospitals in educational reports and articles, submitted comments supporting the National Institute for Occupational Safety and Health Alert, ``Preventing Allergic Reactions to Natural Rubber Latex in the Workplace,'' and participated in the planning and sponsorship of the Food and Drug Administration's May 1998 video teleconference on natural rubber/latex allergy recognition, treatment, and prevention.

Despite these efforts, there is little scientific knowledge about how to effectively reduce the risk of exposure to people with latex allergies. For example, it is very difficult to determine the precise cause of skin reaction under gloves. Some people are truly allergic to latex, while others are allergic to the chemicals used in making the gloves. There also is confusion over the barrier effectiveness of alternatives such as non-latex, low-powder, or powder-free and low-protein latex gloves, which are often less affordable. And the FDA has reported that the process that removes powder from the gloves introduces other chemicals that could cause allergies.

That is why we believe, as does the Centers for Disease Control and Prevention, that hospitals and health systems should target the use of non-latex and other alternatives to areas of a facility where workers have exhibited reactions to latex. OSHA's draft hazard bulletin makes broader recommendations, including the exclusive use of powder-free latex gloves throughout facilities that are not adequately supported by scientific data.

OSHA's draft also ignores important ramifications of its recommendations, including the relative risks and benefits of powdered latex versus non-powdered and other alternatives, as well as the recommendations' cost implications.

It is critical that a consistent message be conveyed by OSHA, CDC, NIOSH, FDA, and all other relevant Government agencies. Because repeated exposure to latex products can have serious consequences for any allergic individual, health care worker, patient, or consumer, accurate and easy-to-understand information that raises the level of awareness is both necessary and welcome. However, such information must closely adhere to available scientific data and place reported incidents in the proper perspective. In other words, we must not unnecessarily discourage the widely accepted use of natural rubber latex gloves that offer patients and health care workers critical protection from the HIV virus, hepatitis, and other infectious agents.

Mr. Chairman, we urge OSHA to refrain from issuing the hazard bulletin in its present form and to adopt a more balanced perspective, buttressed with solid data and supported by real evidence of the potential benefits of its recommendations. And we look forward to working with Congress and the Federal agencies involved to make sure policy decisions about latex allergies are reasonable, based on sound science, and truly protect health care workers and the patients they serve.

Thank you for the opportunity to be here.

[The statement of Ms. Kicklighter follows:]

WRITTEN STATEMENT OF LAILENI KICKLIGHTER, ASSISTANT ADMINISTRATOR, RISK MANAGEMENT SERVICES, NORTH BROWARD HOSPITAL DISTRICT, FORT LAUDERDALE, FLORIDA, ON BEHALF OF THE AMERICAN HOSPITAL ASSOCIATION -- SEE APPENDIX D

Mr. Norwood. Thank you, Ms. Kicklighter.

Dr. Reed, you may begin.

Dr. Reed. Thank you for the opportunity to be here. I appreciate it. I am Charles Reed, emeritus professor of medicine at the Mayo Clinic. I have done considerable research on latex allergy and was honored to see that OSHA cited one of my research papers in its technical bulletin.

For the last 9 months, I have been a consultant to Allegiance about latex allergy and have been compensated for my time and expenses. My arrangement with Allegiance allows me at all times to express my medical opinions on this issue. The comments I am about to make and the opinions are my own and do not express the policies of Allegiance, the Mayo Clinic, or any other organization.

OSHA's goal of education about occupational allergy to natural rubber is laudable. I have a serious concern, however, that some of the wording in the document will do more harm than good.

By using low-allergen gloves, the Mayo Medical Center has been able to reduce exposure to latex allergy substantially. Our staff members who have allergic disease from latex are now working at their usual positions without difficulty. However, patients coming to Mayo from other locations exhibit a new problem that is much more disruptive of their lives than the cases on our own staff.

Because of the sensationalism that has developed around latex allergy, many health professionals become terrified of their workplace. They have been led to fear that exposure to rubber in any form may kill them and that they can no longer use their years of training and skill. The majority of the cases called latex allergy coming to Mayo now are of this kind. Many of these patients aren't even allergic to latex. They just fear that they are. My concern about the current draft of the technical bulletin is that much of its present wording will feed these fears and make the overall problem worse rather than better.

On the technical side, OSHA's bulletin fails to draw an important distinction between the nature of latex allergy that we see among health care workers and other people occupationally exposed to rubber, and the problem of anaphylaxis, which occurs in patients undergoing surgery and medical examinations. These two conditions have separate and distinct clinical courses. The most common symptom of latex allergy is hives under the glove. The second most common is upper respiratory allergy and asthma from the airborne allergen in the air. This respiratory allergy is fundamentally no different than an allergy to cats or to pollens or any other sort of hay fever or asthma.

Now, anaphylaxis involves many organs, including the heart, and it occurs not from local contact but when the allergen circulates in the blood after injection or absorption through serous surfaces, that is peritoneum or pleura, or from the gastrointestinal mucous membrane.

In searching the medical literature and discussing this problem with my colleagues, I found only two substantiated cases of systemic reactions to airborne latex at work. Both these people responded promptly to treatment.

The occupational allergy from latex is caused by exposure to latex allergens, not to the cornstarch powder. It is to the allergens that are carried on the powder. The focus, therefore, should be on the total allergen level that people are exposed to, not on whether it is powdered or not.

We have found that powder-free as well as powdered gloves can release allergens into the air, and there are powdered gloves on the market that have less allergen in them than some of the non-powdered gloves that are on the market. It isn't the powder; it is the allergen.

I would like to close by leaving you with this thought: If OSHA's technical bulletin is to fulfill its intended purpose of educating people about latex allergy, it must be accurate and not alarming. Unfortunately, there are many inaccurate and alarming statements in the bulletin as it is presently written.

Thank you.

[The statement of Dr. Reed follows:]

WRITTEN STATEMENT OF CHARLES E. REED, M.D., FORMER CHIEF, DIVISION OF ALLERGY AND INTERNAL MEDICINE, AND EMERITUS PROFESSOR OF MEDICINE, MAYO CLINIC, ROCHESTER, MINNESOTA -- SEE APPENDIX E

Mr. Norwood. Dr. Reed, and to all of you, your full testimony will appear in the record. I realize in 5 minutes sometimes we all don't get through, but the full testimony of all of you will be in the record. Thank you very much. Dr. Rose.

Mr. Rose. Good afternoon. My name is Tim Rose, and I am currently the president of the American Dental Association. It is a pleasure to be here today both as a representative of the American Dental Association's 143,000 member dentists and as a practicing periodontist who uses latex gloves on every patient that I treat.

My testimony will focus on the use of latex gloves and latex products as they are used to deliver dental and oral health care to the American public.

Let me clearly state the American Dental Association's current position. OSHA should not be involved at all in the medical latex glove issue. The FDA has taken, and should continue to take the lead, in regulation of this area. It is clearly their job. Voluntary initiatives and self-regulation should be encouraged because they have worked and continue to work.

All practicing dentists must wear gloves when treating patients. At present, most gloves are made of natural rubber latex. They provide excellent barrier protection against bloodborne pathogens, and, in addition, latex gloves are inexpensive, lightweight, tear-resistant, and have a long shelf life. We do know that both dentists and patients are at risk for latex hypersensitivity and that the consequences can be catastrophic for affected individuals. But the extent of this risk is not clear, and no easy solution is readily apparent.

The dental profession is firmly committed to take whatever appropriate actions might be in the future. Our action has been, and will continue to be, through scientific research, professional education, and the adoption of the best practices in dental offices around the country.

I want to offer you some comments about the events that precipitated this hearing. OSHA circulated the first draft of its hazardous information bulletin on latex allergies to outside stakeholders in late 1997. That bulletin was aimed at OSHA inspectors. The agency wanted to alert them to latex allergies as an emerging hazard in the health care workplace. The first draft placed new obligations on employers, despite the fact that OSHA had no authority to do so.

The second draft was an improvement. It contained a disclaimer stating that the bulletin was, and I quote, ``not a new standard or a regulation but, rather, advisory in nature and informational in content.'' The ADA still questions OSHA's authority on this issue.

The ADA never saw the final version of OSHA's technical bulletin on latex allergy. We learned just last week that OSHA had indeed prepared the final version of the technical bulletin in February and distributed it to all regional offices. Three weeks later, OSHA recalled it. We do not know why.

The ADA believes that any Federal regulation pertaining to medical latex gloves belongs to the FDA Center for Devices and Radiological Health. Latex gloves are properly viewed as medical devices. To date, the FDA has done an excellent job regulating latex gloves. Its actions have been responsive and sensible. Steps taken or currently being taken include a comprehensive report on glove powder, requirements for labeling to permit consumers to make informed decisions, regulations on the allowable amount of powder in gloves, and regulations of the allowable level of protein in gloves.

The ADA has undertaken a number of important initiatives to inform the dental profession and the public about this issue. In 1998, an article by Hill indicated that 3.8 percent of the health care workers tested had latex sensitivity.

Since 1994, the ADA Health Foundation has addressed the gap in scientific understanding about latex allergy by screening dentists and other health care workers every year at its annual session. To date, the ADA has screened in excess of 7,000 dentists and dental office employees. The data indicates that 6.2 percent of the dental office employees screened may have had some risk of sensitivity to allergens from natural rubber latex. Both of these studies relied on valid scientific tests to evaluate latex sensitivity.

In February of 1999, an issue of the Journal of the American Dental Association contained a comprehensive report on latex hypersensitivity geared towards practicing dentists. It offers practical recommendations for reducing exposure. Following the publication of that article, voluntary action was taken to revise the guidelines for infection control products that receive the highly respected ADA Seal of Acceptance. This action recognizes that low-protein and powder-free gloves, as well as synthetic gloves, can be used to help protect individuals by reducing the risk of sensitization or allergic reactions.

In conclusion, I would like to emphasize three main points that I made earlier. First, the ADA does not see any need for OSHA to regulate or even offer guidance about gloves or other products containing natural rubber latex. Secondly, the ADA does think that it is appropriate for the FDA to continue to regulate this area. And, third, the efforts of non-governmental organizations should be encouraged and recognized. The ADA will continue to contribute its influence to this process. In the face of emerging science, we take every reasonable action to protect not only our patients but our members and workers in the dental office. We clearly do not need OSHA's help.

Thank you, Mr. Chairman.

[The statement of Mr. Rose follows:]

WRITTEN STATEMENT OF S. TIMOTHY ROSE, PRESIDENT, AMERICAN DENTAL ASSOCIATION, WASHINGTON, D.C. -- SEE APPENDIX F

Mr. Norwood. Thank you very much, Dr. Rose. Mr. Eberts.

Mr. Eberts. Thank you, Mr. Chairman, and thank you for this opportunity to appear before this committee.

Allegiance is very concerned about latex allergy. We manufacture more than 1.5 billion natural rubber latex gloves each year, and we have invested substantial efforts to address the issue of latex allergy. We put latex identification statements on our products before the FDA required it, and we fully supported the FDA's efforts to have others in the industry use the same labeling.

We have developed educational programs for health care professionals. Over half the hospitals in the country today now have standing committees to manage latex allergy, and more hospitals are creating new committees each month.

OSHA's proposed bulletin on latex allergies is a step backward in these efforts. It effectively overrules the FDA's procedures to review and approve medical devices. Hospitals will be subjected to enforcement actions without the opportunity to have been heard in a rulemaking process. And the proposed bulletin simply sends the wrong message about latex allergies and the importance of barrier protection.

While Allegiance would profit considerably by OSHA's recommendations since its recommendations would require our hospital customers to buy our most expensive products, we believe that those recommendations would endanger American lives.

Latex gloves are natural products, and latex allergy is a natural allergy. It is a plant allergy to the rubber tree, similar to allergies to pollen or ragweed. It is a problem for a small percentage of Americans, but it is also a manageable one.

According to the FDA, nearly 15 billion powdered latex gloves were used in the United States in 1996, about 80 percent of the gloves used. They are the gloves of choice by surgeons and other professionals because they preserve sensitivity and meet their clinical needs. To date, there are no documented fatalities from the use of this product, and I believe any claims of fatalities related to the use of powdered latex gloves are unsupported.

Consider that penicillin causes approximately 7.1 fatalities for every 7.5 million uses. Yet no one would suggest banning penicillin because it results in rare fatalities and causes a lesser reaction in a small percentage of people.

In comparison, less than one allergic reaction of any kind has been reported to the FDA for every 49 million natural rubber latex gloves used. Still, there is a conflict between two agencies regarding this product.

The FDA, which is responsible for regulating powdered latex gloves, has cleared them for use by health care professionals. They are safe and effective products. However, OSHA intends to issue a bulletin, which labels these life-saving products as unsafe and directs or recommends clinicians to stop using them.

The proposed bulletin is causing confusion about the safety of natural rubber latex gloves with professionals and the American public. OSHA simply cannot regulate away an allergy. But the FDA has invested millions of dollars over many years regulating natural rubber latex products and has announced that it intends to begin additional rulemaking concerning that product.

We recognize that OSHA has a responsibility to ensure worker safety, but its proposed bulletin would erase advances in latex allergy education and undermine the FDA's specific efforts to regulate these products.

There are also serious credible questions about the unethical and fraudulent science relied upon by OSHA. For example, with the financial interest in promoting a ban on these products, London International Group funded research by more than six researchers that were cited by OSHA. A Federal district court for the United States District Court in Georgia noted that although OSHA is apparently aware of allegations of fraud and other inappropriate conduct by the London International Group, the agency has not pursued the matter further.

We repeatedly informed OSHA that it was relying on Dr. Margaret Fay, whose credentials were proven to be largely falsified. In its most recent version of the bulletin, OSHA finally removed references to Dr. Fay. The reason, in OSHA's words, was that Dr. Fay's lack of credentials ``were objectionable to Allegiance,'' but apparently not to the agency.

OSHA has ignored recognized research that showed that latex allergy is not linked to occupation and has failed to acknowledge the Government's own data on latex sensitization collected by the National Center for Health Statistics. This survey, the largest of its kind, was endorsed by Surgeon General Satcher as the gold standard in data collection.

Some States have already used the proposed draft OSHA bulletin as a basis for State legislation that would ban latex devices, from gloves to condoms, leading to a patchwork of conflicting State regulation and undermining the FDA's role as the standard-setting agency for medical devices.

We believe the actions taken by the FDA are sound, and we would strongly request that the committee consider the following actions. First, through the appropriate use of this committee's investigative and subpoena powers, the committee should investigate the credible claims of scientific fraud and bias since OSHA has chosen not to do so. Second, through this committee, Congress should instruct OSHA not to prohibit the use of medical devices that have been cleared or approved by the FDA.

Mr. Chairman and members of the committee, I want to thank you for giving me the opportunity to testify before you on this issue, and I am happy to answer any questions you may have.

[The statement of Mr. Eberts follows:]

WRITTEN STATEMENT OF F. SAMUEL EBERTS III, ASSOCIATE GENERAL COUNSEL, ALLEGIANCE HEALTHCARE CORPORATION, McGAW PARK, ILLINOIS -- SEE APPENDIX G

Mr. Norwood. Thank you, Mr. Eberts. Dr. Hamilton.

Mr. Hamilton. Thank you, Mr. Chairman, and fellow U.S. citizens.

Allergic disease to proteins in natural rubber latex is a very serious and a real occupational disease that afflicts approximately 10 percent of health care professionals. The presence of allergenic protein in natural rubber products in the workplace represents a hazard both to the occupationally exposed worker as well as to the public that we serve.

I am here today to strongly support the publication of the OSHA bulletin. It is my firm belief that this document, with minor modifications, which I have suggested in my written testimony, will provide unique, current education to the OSHA staff, which is not provided by the aging 1997 NIOSH alert.

In turn, an educated OSHA workforce will then promote safer practices in the workplace and educate our workforce on practical solutions to this latex allergen hazard. OSHA got it right in 1997 when its first draft of the document was labeled ``a hazard information document.''

Almost a hundred years ago to this day, Dr. Halsted, a surgeon from the Johns Hopkins Hospital, contracted Goodyear to manufacture what our historians have told me is the first pair of medical gloves used in a medical environment. Early in this decade, following the advent of universal precautions, cases of natural rubber latex allergy began surfacing in our hospital staff at Johns Hopkins, as they did in hospitals across the country. We chose to be proactive and to initiate changes in our hospital, which have led us to the decision to replace, with synthetic alternatives, medical devices that contain natural rubber latex, including gloves. The reasons and scientific data to support our decisions are enumerated in my written testimony.

Since we purchase over $1 million worth of gloves every year, our volume has permitted us to convert from powdered latex to synthetic non-sterile examination gloves in a safe way, which has essentially cost us no increase over this past year.

In my remaining time, I would like to focus on the suggestion that there is no difference in latex sensitization rates between health care workers and non-health care workers. Some would have us believe that latex allergy is not an occupational disease. This is wrong. The fundamental flaw in the reasoning comes from the artificial segregation of the NHANES III data just alluded to by Mr. Eberts. The NHANES III data was segregated according to occupation, health care worker versus non-health care worker, and not according to the extent that subjects were exposed to latex allergen in the workplace.

For instance, consider the severely latex allergic Baltimore farmer who almost died during surgery before we started instituting a change in latex to synthetic gloves. He would have been classified as a non-health care worker who is latex allergic, and he should have been classified as a worker who was exposed to natural rubber latex allergen. His sensitization came from daily use of powdered latex gloves in the field to protect his hands.

Alternatively, consider our nurse administrators that don't use gloves on a routine basis and our laboratory workers that prefer to use synthetic gloves. These two groups are not exposed to allergen, and, therefore, they would not be expected to develop a latex allergy. So latex allergy is an occupational disease, but one needs to examine it within the context of the extent of exposure to allergen and not using artificial job classifications.

NHANES III, which is a cross-sectional study, was not designed to monitor the extent of true subject exposure to latex and is not designed to give us true prevalence and true risk assessment, based on even Michelle Pearson's assessment from the CDC.

So, in conclusion, latex allergy is a disease, which stems from an occupational exposure to natural rubber latex products. The largest single source, in our opinion at Johns Hopkins, is the powdered latex glove. It is my firm belief that the OSHA bulletin, with minor modifications, will be a great educational tool to the OSHA work staff. In turn, they will educate the American workforce when visiting our workplaces and ultimately help the public that we serve.

Thank you.

[The statement of Mr. Hamilton follows:]

WRITTEN STATEMENT ROBERT G. HAMILTON, PH.D., ASSOCIATE PROFESSOR OF MEDICINE AND PATHOLOGY, JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, ASTHMA AND ALLERGY CENTER, BALTIMORE, MARYLAND -- SEE APPENDIX H

Mr. Norwood. Ms. Wilburn.

Ms. Wilburn. Good afternoon Chairman Hoekstra, Vice Chairman Norwood, and members of the Oversight Committee. My name is Susan Wilburn. I am a registered nurse, and the senior specialist for occupational safety and health at the American Nurses Association. I am here today representing the Nation's 2.5 million registered nurses and on behalf of the coalition of labor unions that represent health care workers to support OSHA's technical information bulletin.

I am disappointed that there are no affected health care workers up here to describe their own stories of how they were treated and what occurred without having the information from this bulletin in the workplace.

As a member of NIOSH's National Occupational Research Agenda Advisory Committee on Allergic and Irritant Dermatitis, I have been working together with NIOSH, OSHA, and the FDA on this problem since 1996. I was a member of the planning committee and a speaker at the FDA teleconference, which other speakers have mentioned, which occurred last May.

ANA is an advocate on this issue because we have seen a dramatic increase in reports of registered nurses being affected and sometimes permanently disabled by latex allergy. Over the past 5 years, this occupational illness has reached epidemic proportions among health care workers.

In general, it is now more dangerous to work in the health care industry than it is to work in mining or construction. According to the Bureau of Labor Statistics, there were over 700,000 reports of injury and illness to health care workers in the last year, and this does not include the estimated over 1 million needle-stick injuries per year. And given that research has shown that 10 to 30 percent of health care workers report the occupational injury and illnesses to the Bureau of Labor Statistics, it is more likely that there are 2 million incidents a year.

Latex allergy is a growing concern among registered nurses and health care workers, and with the prevalence data that research has demonstrated, up to 200,000 nurses in the United States are sensitized to latex.

The prevalence rate of latex allergy among health care workers across the industrialized nations is similar to what we have seen in this country, Canada, the United Kingdom, Germany, and Finland. And the German Government has recently implemented a reduced-protein and powder-free requirement for health care facilities because of the exorbitant rates of workers' compensation in that country. And powder-free gloves are the standard in Britain.

This allergy can be, as you have heard, a debilitating and career-ending illness for nurses. Chronic exposure in an allergic worker can lead to permanent pulmonary and cardiac disease and premature death.

The data, which includes hundreds of studies, show that latex allergy is a real and serious threat not only to health care workers but also to the patients that we care for. And one piece of evidence of the increasing prevalence is the purchase of Medic Alert bracelets. In 1985, over 10 years ago, there were 20 requests for latex allergy ID bracelets, and as of March 8th of this year, there have been over 10,000 requests for these bracelets, which cost $70 and are not an insignificant purchase.

Latex allergy affects 51 percent of children with spina bifida from their repeated exposure to latex products during surgery, and nurses who work in surgery and in the emergency room have the greatest concern because patients often come to them unconscious, in anaphylactic shock, and unable to communicate. Sometimes patients don't know that they have a latex allergy until they are in shock, similar to a bee sting or peanuts. People can have bee stings or they can eat peanuts and peanut butter all of their lives, and one day they reach a threshold of exposure that triggers anaphylaxis.

Take the case of Nurse Cheryl Mohrbacher. Cheryl was at work when she had an asthma attack brought on by exposure to powdered latex gloves. She died subsequently that evening at the end of her evening shift in the emergency room of the small Oregon community hospital where the physicians and nurses used latex gloves while treating her.

Powdered latex gloves are the biggest threat to nurses because of the latex powder that attaches to the protein, as you have previously heard. When you pull on a latex glove, that powder sprays into the air, and you can inhale the latex protein attached to the powder.

Nurses are now wearing up to 50 pairs of gloves per day in the areas like labor and delivery where a lot of gloves are necessary.

So how do we solve the problem?

By exclusively using powder-free or non-latex gloves, we can save lives and prevent health care workers and patients from developing the allergy. ANA and many other organizations have been urging medical facilities to take these simple steps for a few years now. It was in 1997 that the American Academy of Allergy, Asthma and Immunology along with the American College of Allergy, Asthma and Immunology issued a joint statement stating that no powdered latex products be used in the provision of health care. In 1998, the American Academy of Dermatology also called for the elimination of glove powder. These three organizations represent the medical specialists that treat my colleagues that have latex allergy.

Clearly, latex allergy is preventable. There are powder-free gloves as you have heard, and non-latex alternatives that have been approved by the FDA and determined by the CDC to provide adequate barrier protection to prevent exposure to bloodborne diseases.

For example, in the early 1990's, when the Mayo Clinic, a pioneer in this area, decided to change and switch to powder-free, low-allergen gloves in their facilities, they saved $200,000 in the first year because of the competitive bidding process. And they changed because of what they said was characterized as an epidemic of latex allergy in their facilities.

You have heard from Dr. Hamilton about Johns Hopkins' change to vinyl gloves. In addition, Kaiser Permanente's 700 hospitals in California, Sisters of Providence in Oregon, Methodist Hospital in Indiana, and Emory University in Atlanta have all made significant changes to eliminate powdered latex products and to use low-protein, powder-free gloves.

ANA applauds Assistant Secretary Jeffress and OSHA's direction on this issue. Under the Occupational Safety and Health Act of 1970, OSHA is charged with ensuring a safe and healthful workplace. If this bulletin is prevented from immediately going forward, essential and life-saving information will be denied to health care facilities and health care workers across the country.

ANA believes there should be a standard about latex allergy, but we are not discussing a standard today. We are just talking about a technical information bulletin, which is the bare minimum that is needed to protect health care workers.

ANA respectfully requests your support for the immediate publication of this bulletin that is critical to protect the health and safety of millions of nurses, physicians, dentists, and other health care workers, not only in your districts but across the country.

Health care workers need this bulletin not only for our own protection but also for that of our patients. Thank you very much for the opportunity to speak with you today. I would be happy to answer questions.

[The statement of Ms. Wilburn follows:]

WRITTEN STATEMENT OF SUSAN Q. WILBURN, RN, SENIOR OCCUPATIONAL HEALTH AND SAFETY SPECIALIST, AMERICAN NURSES ASSOCIATION, WASHINGTON, D.C. -- SEE APPENDIX I

Mr. Norwood. We will now watch the videotaped testimony of Dr. Koop.

Dr. Koop. [Via videotape.] Mr. Chairman, I would like to express my appreciation to your subcommittee for their courtesy in permitting me to testify by videotape and thus keep an speaking appointment that has been on my books for over a year.

There is an inherent threat to the public safety when one Federal agency competes with another in addressing a regulatory issue in a myopic, uncoordinated, or haphazard manner. I personally witnessed this situation when I was Surgeon General in the early days of the AIDS epidemic. I am greatly concerned that public safety now could be jeopardized by the current handling of natural rubber latex glove regulation.

Latex gloves, like all latex medical devices, are currently regulated by the United States Food and Drug Administration. Since September 30, 1997, the FDA has required that labels warning of latex sensitivity be placed on all natural rubber-containing medical devices. The Occupational Safety and Health Administration and other agencies must not be allowed to invade the province of the FDA to regulate medical devices, especially when the resulting lack of coordination poses a serious threat to the health and safety of the American public.

Mixed messages have already appeared because of such an ill-advised approach. For example, the CDC has long warned that oil-based creams and lotions can degrade the barrier quality of latex. In addition to OSHA, in 1997, the National Institute of Occupational Safety and Health, or NIOSH, also issued an alert which recommended the use of oil-based hand creams and lotions in direct contradiction of the CDC's warning. Although NIOSH later rescinded this recommendation, you can see how the health care community could be confused. In fact, the 1997 alert is still being circulated by some State agencies.

The point is that fundamental barrier protection was imperiled by NIOSH's shortsighted efforts to combat latex allergy. This example of ``throwing the baby out with the bath water'' underscores why it is critical to have a unified and coordinated regulatory approach to the issue of latex sensitivity without losing sight of the far greater problem of halting the spread of deadly infection.

Latex gloves are crucial to health care workers and their patients in the fight against pathogenic organisms, including human immunodeficiency virus, HIV, and hepatitis B and C. Thanks to the use of billions of latex gloves, millions of people live with almost total assurance that medical care they receive will not permit transmission of deadly viruses. Whenever latex gloves are used, both patient and health care worker are protected from infection.

A very small percentage of the population experiences some level of allergic reaction to latex. Put in perspective, as of August 1997, the FDA had received about 1,650 reports of possible allergic reactions to latex gloves even though more than 100 billion gloves were used. None of these reports involved death, and the vast majority of reports involved minor reactions such as skin irritations. In contrast, by the end of 1988, over 46,000 people, 700 of them children, had died of AIDS in just the United States. The situation is not improving. In 1997 alone, just in the United States, over 10,000 people died from hepatitis and another 16,000 died from AIDS.

Numerous studies about latex allergy have been conducted. The most complete and comprehensive study of latex sensitivity to date is the third National Health and Nutrition Examination Survey conducted by the CDC's Center for Health Statistics, known as NHANES III. The study is the largest United States Government-sponsored study of its kind and included the testing of 40,000 randomly selected subjects at 88 locations nationwide over a 3-year period. NHANES III showed that latex allergy is really no different from other common allergies. Over 90 percent of people have no evidence of an allergy to latex.

Perhaps the most important data from this study is that health care workers are no more sensitive to latex than the population at large. This data makes sense considering that as many as 40,000 common objects contain latex, including tires, children's toys, and condoms. These findings are also corroborated by other published studies.

In the past few years, confusion bordering on hysteria has caused latex gloves, especially powdered gloves, to come under attack. This hysteria, reminiscent of the hysteria surrounding AIDS in the early years, has caused health care workers in particular to become unduly frightened about developing latex sensitivity and allergy because of their glove use at work.

OSHA has fueled this hysteria by interjecting itself into latex glove regulation. It has circulated a draft hazard information bulletin throughout the health care industry that, if heeded, would literally eliminate powdered latex gloves from the workplace. On February 17, 1999, OSHA released a technical information bulletin which, just short of an outright ban, strongly discourages the use of latex gloves by all health care workers and encourages the use of powder-free and low-protein gloves by workers who continue to wear latex gloves. The FDA and the CDC's advisory committee have rejected similar recommendations. OSHA's bulletin is directly at odds with the approaches taken by the FDA and the CDC and ignores the data of the CDC-sponsored NHANES III in favor of private studies.

My concern is that OSHA overlooks the big picture, which is that the bulletin's recommendations will undermine the universal precautions taken by health care workers by scaring people away from glove use and by limiting glove choices. A spin-off of this is that years of teaching condom use to prevent sexually transmitted diseases could be undermined as well.

Latex sensitivity is a legitimate matter of concern to those who are allergic and is an appropriate subject of Government study. I am concerned that agencies such as OSHA are eliminating glove choices in the workplace without any regard to the safety of the vast majority of health care workers or their patients who are not allergic to latex. Therefore, I support the regulation of latex gloves by the FDA, the agency that currently regulates latex gloves and all other medical devices.

I served this country as Surgeon General from the onset of the AIDS epidemic, and my mission during that time was to promote safety and to protect the public health. I fear that OSHA's initiatives, while well intended, will jeopardize the safety of the public by discouraging the use of latex as a barrier protection against infectious diseases.

I strongly caution agencies, such as OSHA, from taking independent actions, and instead I strongly encourage them to forward their findings, if any, to the FDA, the agency that has been studying latex allergies for the past 30 years.

Thank you, Mr. Chairman.

[The statement of Dr. Koop follows:]

WRITTEN STATEMENT OF C. EVERETT KOOP, M.D., FORMER UNITED STATES SURGEON GENERAL, WASHINGTON, D.C. -- SEE APPENDIX J

Mr. Norwood. I would like to remind our members that Committee Rule 2 imposes a 5-minute limit on questions, and the chairman will shortly recognize members for any questions that they may wish to ask.

I would like to point out to the panel that I believe sometime in the next 30 minutes we are going to be asked to go to the floor to vote, and we will do that and dispatch ourselves back over here as quickly as we can. Perhaps that will give you a minute to stand up and stretch.

I would also like to observe before we start the questions that there is a clear difference of opinion as to how we should handle this problem. There is a difference of opinion of how large the problem is. That is the whole point of this hearing, for us to very clearly get testimony from people who are involved in this area to understand how we may better solve the problem, if we can solve the problem from the Federal level.

One of the reasons, Ms. Wilburn, that there are not patients sitting at the desk is simply because we do not have any question about the fact that wearing latex gloves could lead to allergies. That is not the point of this hearing. Everybody up here, and I think everybody out there, agrees to that. So that is not what we are after. We are trying to sort out the best way to handle this problem amongst many problems in this country regarding health care, and many different allergies that people have.

Now, I had better start, hadn't I, Tim?

Mr. Roemer. I hope you do that for me.

[Laughter.]

Mr. Norwood. I wish that Dr. Koop could have been with us today because I think his testimony raises an extremely important question of whether the OSHA bulletin could undermine universal precautions taken today by health care workers and basically scare people away from glove use and also limit glove choices.

I fear for that as well, and, Dr. Jacobson, I would love to have you comment on that.

Ms. Jacobson. Well, I think that we certainly feel that latex is a good barrier, and we feel that it is safe and effective for most uses and for most patients. And it certainly has a lot of uses in medical devices.

We also think that allergy is a real problem, and this is one of the reasons we promulgated our regulation requiring that devices be labeled to say that they contain latex so that patients and health care workers who are sensitive can stay away from them.

Mr. Norwood. So it is not the position of the FDA that we should ban latex gloves. It is instead that we should make people aware of the potential harm. Is that_

Ms. Jacobson. Just as with any substance that people can be allergic to, correct. The idea is to let people know that the devices contain latex so that if they are allergic, they can stay away.

I think we also are concerned that we try to prevent the increase of sensitization to the extent that is possible. That is one of the reasons why we have been emphasizing the importance of trying to reduce latex proteins that are contained in the latex products. We have been working hard to come up with test methodologies and since 1995, have allowed manufacturers to make claims of reduced latex protein. We had to wait to do that because we didn't have a good test methodology until 1995.

And so, again, trying to reduce protein levels, trying to reduce powder levels, all of those things should be helpful in trying to deal with the whole issue of allergy, which is a hard issue.

Mr. Norwood. Yes, it is. It is very hard. You never know from whence it came. Is it also your testimony that presently, the latex gloves used today in this country are a good barrier? Are latex gloves the best barrier of choice?

Ms. Jacobson. Well, I think when you say ``best barrier,'' in overall terms, you must take everything into consideration such as costs, relative cost, relative availability, and the fact that people like the tactile sensation that they have with latex; I would say latex gloves are just an excellent barrier. It is not the only barrier, and certainly being an excellent one doesn't mean that it doesn't have any downsides. And one of the downsides is that it does have these natural proteins that some people in the population can be allergic to.

Mr. Norwood. Now, my question for the panel was that OSHA's bulletin could perhaps undermine universal precautions taken by health care workers and basically scare people. Of course, OSHA scares people. It doesn't matter what they say. I don't care if they put flowers on their bulletin. Basically, folks worry when they hear from OSHA. But could it scare people away from glove use? Does anybody want to comment on that? Dr. Hamilton?

Mr. Hamilton. Yes, Mr. Norwood. Johns Hopkins has taken a very proactive role in this process, and we don't feel we have been scared. We don't feel we are frightened. We haven't stopped using gloves. We have just decided to remove the latex glove from our institution.

Mr. Norwood. Why did you do that?

Mr. Hamilton. We did that primarily because the science that we did and that was done at other institutions in the world told us very clearly that we could not define a level of allergen that is safe.

Mr. Norwood. So you did that before OSHA put out anything?

Mr. Hamilton. Exactly. We worked with the Mayo Clinic_

Mr. Norwood. I can't imagine your doing that. Why in the world would you have done something like that without OSHA?

Mr. Hamilton. Well, no, we started doing this in 1994.

[Laughter.]

Mr. Norwood. I am sorry, but the point here is that you took action and that is fine with me. I hope it is the best decision in the world. I am proud of you if it works for you. Are you a physician?

Mr. Hamilton. I am a Ph.D. researcher.

Mr. Norwood. However, generally speaking, the people at your institution figured out that this is something you wanted to do because you were having this problem, without any help from OSHA. And I have a hunch that a lot of people in the country can get this figured out, too. Particularly people who are smart enough to have to use gloves to start with. I mean, the nursing profession is made up of a lot of smart people. They have got this figured out as well, without OSHA playing a part in it.

What we want to do is solve the problem. The question before us today is whether we need any help from OSHA to solve the problem.

My time is up. Dr. Reed, I will speak to you in the next go-around. Mr. Roemer?

Mr. Roemer. Thank you, Mr. Chairman.

First of all, I want to ask Dr. Presson a quick question. With a technical advisory information bulletin that OSHA has issued, is there anything that has a regulatory nature in that?

Dr. Presson. Our technical information bulletin is certainly not regulatory. We do discuss our bloodborne pathogens standard, which is regulatory, but this is simple advice for our compliance officers and meant to inform them as to what other people are doing to figure out the situation.

Mr. Roemer. Now, do you have a draft proposed regulation or a proposed rule that you are contemplating in this matter?

Dr. Presson. We have not even contemplated a rule in this area.

Mr. Roemer. Dr. Koop seemed to indicate that there was kind of a conflictual relationship at times between FDA and OSHA. I seem to have just the opposite indication, that FDA and OSHA have worked pretty closely here, although they have different jurisdictions. How would you categorize your working relationship at this point?

Dr. Presson. We have worked very closely in this area for over 2 years, including numerous meetings and scientific panel presentations. I don't know what basis Dr. Koop would have for making that statement, but we certainly have worked closely together and cooperatively.

Mr. Roemer. Dr. Jacobson, do you agree with that assessment?

Ms. Jacobson. Yes, I think we have different and sometimes overlapping authorities, but we concentrate on the products and OSHA concentrates on the workplace.

Mr. Roemer. One of the interesting things to me here in terms of the overlapping jurisdictions or the distinct jurisdictions is that Dr. Hamilton, being a Ph.D. and being at Johns Hopkins and so forth, has access as a researcher to a great deal of information. What OSHA does, apart from what FDA does_FDA provides important information on labeling and medical devices and so forth. OSHA has a little bit different jurisdiction to the workplace. And when I talked with James Clark and Mrs. Clark a little bit earlier, they were a little bit more concerned about the situation that might take place in the workplace rather than at Johns Hopkins where, if he got hurt and he was on his own and a volunteer fire department official came to take care of him and didn't even have knowledge of the latex glove allergy problem, that could be a big problem for James.

So I think that there is a different jurisdictional issue that you two look at times, too: one, hopefully getting common-sense and scientific-based information out there, Dr. Presson, to the workplace, and Dr. Jacobson's area is a bit different in terms of the medical areas.

Do you see a conflict, Dr. Presson, in simply trying to get more accurate common-sense information out to the workplace in this instance that is of a non-regulatory nature?

Dr. Presson. No, our information is meant to inform our own compliance officers with regard to what is going on in the field.

Mr. Roemer. Does it go to anybody else besides your compliance officers? My information says that the technical advisory information goes only to OSHA employees. Is that correct?

Dr. Presson. It goes to our compliance officers as well as State plans and other places that might have a need for it, such as other State plan consultation services.

Mr. Roemer. Okay. Dr. Reed, I have just a quick question for you. You said, and I appreciate your candor in your opening statement, that you were employed as a consultant by Allegiance?

Dr. Reed. I am sorry. I didn't hear your question.

Mr. Roemer. You said very candidly in your opening statement that you were employed as a consultant by Allegiance. Is that correct?

Dr. Reed. That is correct.

Mr. Roemer. And for how long?

Dr. Reed. Nine months.

Mr. Roemer. Okay. You say in your statement that, and I quote, ``Because of the sensationalism that has developed around latex allergy, some surgeons, anesthesiologists, nurses, and other health care professionals have become terrified of their workplace. Many of their symptoms are due to anxiety attacks. Often, they have been led to fear that exposure to rubber in any form may kill them and that, as a result, they will no longer be able to use their years of training and skill. They often conclude that the professional lives are over. The majority of the cases of latex allergy that my colleagues are seeing now are of this type.''

Now, Dr. Hamilton, I would think, strongly disagrees with that.

Mr. Hamilton. I do.

Mr. Roemer. Now, that is what we run into in Congress all the time. We have two doctors that we have to find out which one has the scientifically based statements here and have it come forward. Can you defend that statement? And I will have Dr. Hamilton_

Dr. Reed. My statement was that for the employees and staff at the Mayo Clinic seen in our division for latex allergy, we were able to take appropriate steps at the Mayo Medical Center to eliminate the problem for these people.

Mr. Roemer. The anxiety problem that they had that they came in for?

Dr. Reed. No. The allergy problem. The exposure to latex allergens was controlled.

Mr. Roemer. You are not talking about, as Ms. Wilburn talked about, the 10,000 people that have requested bracelets that have the allergy?

Dr. Reed. I don't know about_

Mr. Roemer. You are talking about a controlled group.

Dr. Reed. I don't know about those 10,000 people. What I do know is that the patients who are being referred to Mayo or coming there who are_

Mr. Roemer. With an anxiety problems_

Dr. Reed. They are anesthesiologists, they are surgeons, they are nurses, and they have been told at home by their doctor that they are allergic to latex and that if they have the slightest contact with this agent, it may kill them.

Mr. Roemer. Okay.

Dr. Reed. That is what the doctors said.

Mr. Roemer. All right.

Dr. Reed. What the doctor told them is not true.

Mr. Roemer. Dr. Hamilton?

Dr. Reed. They are frightened to death.

Mr. Roemer. Dr. Hamilton?

Mr. Hamilton. It is my impression that when any patient comes into the clinic and is rationally introduced to the issue of latex allergy, accurately diagnosed, given the alternatives, explained what the problem is, they walk away extremely happy and able to work and live in their environment very contentedly. And they are not alarmists. I don't feel that anyone at Johns Hopkins has ever exhibited an alarmist point of view. And I think it is a misnomer to suggest that allergists across the country are alarming people inappropriately. They are educating. Unfortunately, they don't have the tools to diagnose accurately, which is a FDA problem. That is another issue, which we won't discuss today. But I am convinced that they are not alarmed about this issue. They are dealing with it in a very practical manner.

Mr. Roemer. Thank you, Doctor.

Thank you for the extra time, Mr. Chairman.

Mr. Norwood. You are more than welcome. I am glad you noted it.

Dr. Hamilton, what are you a Ph.D. in?

Mr. Hamilton. Immunology.

Mr. Norwood. Immunology?

Mr. Hamilton. Yes.

Mr. Norwood. And, Dr. Reed, you are an M.D.?

Dr. Reed. Yes.

Mr. Norwood. Okay. With that, I would like to turn to the real chairman of this subcommittee, Mr. Hoekstra.

Chairman Hoekstra. I thank the chairman for yielding. Dr. Presson, how is this proposed bulletin used?

Dr. Presson. How will it be used?

Chairman Hoekstra. Yes, how will it be used?

Dr. Presson. It will be used to educate our compliance officers. It started from our compliance officers calling in to our office asking what is this they hear about latex allergy? And we would spend 30 minutes on the phone with a compliance officer explaining these different reactions and that sort of thing. So the bulletin began as an effort to educate the compliance officers and was circulated to stakeholders, so that we could assure accurate information about products, and also to the allergists and other stakeholders, so that we would have good information for our field staff.

Chairman Hoekstra. So it begins with information about the potential allergy.

Dr. Presson. Right.

Chairman Hoekstra. Then it moves into recommended strategies for risk reduction. Does that mean that your compliance officers at that point in time would work with the appropriate people within health care facilities to perhaps implement these strategies?

Dr. Presson. The term ``recommended strategies'' does not mean that they are OSHA-recommended strategies. It refers to strategies that have appeared in the literature and that we are informing our compliance officers of them so that they can inform others. We have health care workers who ask our compliance officers in a hospital what they can do. They can tell them this is what has been done at other places, these are recommendations that have been made by national bodies, and this is what you can do about the situation.

Chairman Hoekstra. Just reading it, I would say that this looks like an OSHA recommendation for what health care facilities should do, but you are saying that is not what it is.

Dr. Presson. It is meant to be a document explaining what has been in the literature as recommended type of strategies.

Chairman Hoekstra. Dr. Jacobson, is the FDA supportive of this technical bulletin? Does it conflict with anything that you have ongoing?

Ms. Jacobson. Well, the technical bulletin really refers to OSHA's area of expertise in terms of the workplace. There are no recommendations in there that conflict with things that we have said. As I said, we tend to concentrate on products and how the products ought to be manufactured and labeled and distributed for proper use. But we don't really get into regulating the workplace.

Chairman Hoekstra. Perhaps there may be potential overlaps or different priorities that the two organizations are working on? I mean, are you protecting medical devices or writing the standards for medical devices? I think those were the words that at least one of you used, that there might be an overlap between the work of the two agencies.

Ms. Jacobson. Well, originally back in the late 1980s and early 1990s, when we were working with products that were made of latex, the big concern, as Dr. Koop said, was in terms of barrier properties. And barrier protection was really our primary concern. When the allergy issue came up, we were concerned initially because we were getting reports from patients, and our job is to protect patients and ensure that devices are safe and effective. We then realized, as the science developed, that obviously the health care workers were also having these allergy problems. So there is somewhat of an overlap.

Chairman Hoekstra. One of the encouraging things that I have heard is that there has been collaboration between OSHA and FDA throughout this process and that you have tried to align and coordinate both agencies. One of the things that we introduced was legislation that talked about harmonization because so often we find that there are conflicting rules and regulations.

Do you have records of the dialogue between the two agencies that shows how you have coordinated the FDA's position with OSHA? Such as the minutes of the meetings and those types of things, where this issue has been discussed, that would show how you worked through these kinds of issues?

Ms. Jacobson. We probably don't have minutes of meetings. We would have dates and times, people who were there, main issues discussed, agendas and things like that. We also would have things that happened as a result of the teleconference that we were involved in sponsoring together.

Chairman Hoekstra. There are no written minutes of the issues that were discussed or the resolution and direction that would clearly state that FDA has no objection to this direction and would state that the direction OSHA is going is consistent with what FDA has stated?

Ms. Jacobson. I am not sure that we have exactly said it in those words. We do have an exchange of letters between our Deputy Commissioner and Mr. Jeffress from OSHA stating the understanding that we are going to concentrate on the products.

Chairman Hoekstra. But nothing on the meetings themselves?

Ms. Jacobson. I would have to go back and look.

Chairman. Hoekstra. Okay. I think that might be of interest to the subcommittee, so that may be a request that we forward on to you. Thank you.

Mr. Norwood. And I do hope all of you understand that we will have written questions for you, and we would appreciate answers in writing. We will never get through everything that we want to ask today.

Ms. Presson, let me just follow up a minute on what Mr. Roemer was saying. Explain to me, why do you need to inform and educate your compliance officers as to the nature of these allergens?

Dr. Presson. Our compliance officers in the field are technical people, industrial hygienists, people who go in and check workplaces. We believe that there has not been as much information in the literature that they would read as there has been in the medical, nursing, and other literature regarding latex allergy. And we believe from our discussions with them that they were unaware of these position statements of the major colleges of immunologists and allergists.

Mr. Norwood. Is every one of your compliance officers an industrial hygienist?

Dr. Presson. No, all of them are not industrial hygienists, but that is generally their background.

Mr. Norwood. What is a compliance officer? Is it sort of like a compliance officer that doesn't let you go too fast on the highways? I mean, is it their job to enforce? What does compliance mean to you?

Dr. Presson. Well, I am not really in the compliance area, so I can't speak fully on that. But they are the people who go out and check institutions to assure that our standards are being met.

Mr. Norwood. Aha. But you don't have a standard.

Dr. Presson. No. That is right. But they still were getting questions from people on those visits about bloodborne pathogens and_

Mr. Norwood. Well, why don't you refer them to experts in the area? Because I can tell you, your compliance officers aren't experts. Refer them to real experts. You can find some experts from the FDA. But if you don't have a standard and you don't have a regulation, I got a sneaky suspicion somebody is not telling me the truth and that 12 months from now, there may be a standard even though it is just a bulletin today. See what I am saying? Compliance officers are the wrong people for you to inform.

I beg your pardon, Mr. Scott. You will certainly get compensated for that interruption.

Mr. Scott. Thank you, Mr. Chairman.

I want to follow up on those comments from a different perspective and ask Ms. Kicklighter if this bulletin is issued, what would you do different than you are doing today? How would that affect the way you run hospitals?

Ms. Kicklighter. We are very concerned about the safety of our employees in our health care organization. If this bulletin is issued as an advisory bulletin, we will continue to educate our employees about alternative barrier mechanisms available for them and continue to advise them where to take any health care concerns.

Mr. Scott. Which is what responsible hospitals are doing now. Is that right?

Ms. Kicklighter. Yes, sir.

Mr. Scott. Dr. Reed, as I understand your testimony, you believe that many of the allegations of allergic reactions are essentially psychological. Is there any way to physically measure whether or not it is truly a reaction or not?

Dr. Reed. Yes, several ways.

Mr. Scott. Could you_

Dr. Reed. Many of these people don't have measurable antibodies to latex, which is the first step. The second step is to expose them under conditions where the exposure has been measured and known, to see whether or not there is a response. This is also what I understand they do at Johns Hopkins.

I am referring to a group of people who do not have antibody, who do not respond with any symptoms whatsoever to deliberate exposure, but who still are very frightened of their environment.

Now, many of these people, when they get through this procedure, are enormously reassured, go back to work, and the problem is over. I wouldn't say that is psychological.

Mr. Scott. Well, the point is_

Dr. Reed. On the other hand_

Mr. Scott. The point is, though, you can measure physically whether or not it is a true allergic reaction.

Dr. Reed. That is correct, yes.

Mr. Scott. Okay. Dr. Rose, do you have any evidence that patients are at risk as a result of the gloves?

Mr. Rose. No, sir. But I would like to comment on that. The study that I referred to, published in 1999 on the 7,000 dentists and dental office workers, showed that on self-appraisal, self-assessment by those folks, almost 20 percent said they had a latex allergy. When in fact, the studies that Dr. Reed is talking about showed that the figure dropped to 3.8 percent of people having the antibody in their bloodstream. So I would suggest to you that there are a lot of other conditions that affect people in the dental profession who stick their hands in latex gloves daily that may, in fact, not be an allergic response to a latex allergen.

Mr. Scott. Does anyone know of any malpractice tort claims that have resulted from the use of the gloves?

Mr. Rose. I am not aware of any.

Mr. Scott. Mr. Eberts?

Mr. Eberts. Congressman, there have been several lawsuits filed on behalf of individuals who are allergic against all manufacturers of powdered gloves, powder-free gloves, and even some others. And I don't believe all personal injury lawyers are motivated only by money. I would not cast aspersions on all of them and would not suggest that we should not take those claims seriously.

However, I think it is also important to realize a context when you hear this debate. As we have said here today, it is a very emotional issue. Plaintiffs' personal injury lawyers have funded and supported conferences. They have funded clients to be independent advocates on this issue. And I think that is cynical and leaves some open doubt as to what is going on.

But let me give you one very quick example. I saw an article about something called the latex protein toxic syndrome. It was not written by a doctor, but I have heard it cited by many doctors at conferences before. It was written by a lawyer. It is not a medical term. It was a scare tactic on the part of the personal injury lawyers because they thought it sounded good.

I think we understand why they did that, and I think that is wrong and dangerous. That fuels this type of debate that is going on. Fortunately, courts refused to permit that type of label to be applied to a plant allergy.

In my opinion, the draft bulletin plays an unwitting and dangerous role in supporting that type of misinformation. I am a little confused today when I hear that people need to be told about this, yet everybody on this panel, regardless of what position they have taken, has told you about the tremendous efforts of the industry, FDA, teleconferences, and all the education that has taken place. I can tell you that whatever the personal injury lawyers may do, I can assure you it won't diminish our efforts or our work with institutions like Johns Hopkins or the Mayo Clinic to continue research or to educate people on latex allergy.

Mr. Scott. Do I understand the answer to that to be that there have been no successful malpractice suits, to your knowledge, notwithstanding the efforts of trial lawyers to find liability?

Mr. Eberts. There have been two actual court decisions, Congressman. One did not find that there was a latex allergy. It was in New Jersey. And there was one in Milwaukee that was the other way. So there have been two, one on each side.

Mr. Scott. Thank you, Mr. Chairman.

Mr. Norwood. Thank you, Mr. Scott.

Dr. Rose, I noticed your eyes blinking on the first question when I was talking about the OSHA bulletin perhaps undermining universal precautions taken by health care workers. Did you want to have a comment about that?

Mr. Rose. Well, only if you think about the average dental office that you hopefully go to on a regular basis. A lot of people walk in and out of that office every day, and we change gloves on every patient who walks in and out. Not only does the dentist change, but every employee who has patient contact changes. And I can tell you that when we look at our statistics across the dental profession, it doesn't appear that the number of folks working regularly in a dental office have any higher incidence of latex allergy than those folks not working in dental offices.

I have two difficulties with what I hear today. One is the difficulty over which regulatory agency has the responsibility. I would tell you the American Dental Association supports the concept that it belongs to the FDA. They regulate many of the other things that we do in delivering patient care, and they should regulate this issue.

The other thing that I hear is a real dichotomy in the scientific evidence that is being laid on the table and the fact that there may not be any real great sound science out there.

Mr. Hamilton. Oh, I disagree.

Mr. Norwood. Time out. Well, there obviously is disagreement on the science, which leads me back to Ms. Presson a little bit. When you are going to educate your compliance officers, are you going to point out to them that there is conflicting literature. For instance, although Dr. Hamilton is positive his way is right, there are other people in other areas that perhaps don't agree that he is right? Are they going to get conflicting stories, as we are getting, or are they going to be told something specific by OSHA that you have decided is the correct way? You don't have to answer that.

Let me ask Ms. Kicklighter from the American Hospital Association: As an association, are you attempting to educate the people that are in your association about latex gloves?

Ms. Kicklighter. Yes, sir. The American Hospital_

Mr. Norwood. Are you, Ms. Wilburn?

Ms. Wilburn. Absolutely.

Mr. Norwood. Of course. Dr. Rose, are you?

Mr. Rose. Yes.

Mr. Norwood. Dr. Rose, you made it pretty clear to me that you feel voluntary educational efforts are a better way to inform workers and patients about latex allergies and frankly, certainly better than OSHA's technical bulletin on the topic. Would you comment on that?

Mr. Rose. The OSHA bulletin is going to go basically to their compliance officers. The journal article that we published 2 months ago went to 143,000 practicing dentists and also the employees in their offices. So I think that we got a lot more coverage than the OSHA compliance bulletin would get.

Mr. Norwood. Do you have any members of your association who change those gloves 50 times a day who perhaps have an allergy related to latex that don't do something about it?

Mr. Rose. I am sure we have people who have the allergy, and I am sure they do things about it.

Mr. Norwood. My partner did, for example.

Mr. Rose. Pardon me?

Mr. Norwood. My partner did. It was amazing. I was amazed. He was a good dentist. I couldn't imagine him figuring out that he had a latex allergy, and then doing something about it. Well, do you think the members of your association have a great concern and a great need to make sure that all the other employees in your office don't have a serious health care problem of any kind, to include the allergy?

Mr. Rose. Clearly, we do, and we have done a lot of effort at that.

Mr. Norwood. Are latex allergies like other allergies to dust or ragweed or a bee sting? Is there any difference, Dr. Reed?

Dr. Reed. No.

Mr. Norwood. It means the same thing?

Dr. Reed. It means the same thing. The big difference between a bee sting and ragweed is the route of administration. The ragweed is in the air and hits the eyes and the nose and a little bit in the lung. A bee sting is injected into the skin.

Mr. Norwood. Should OSHA send out warnings to beekeepers?

Mr. Hamilton. Yes. I am a beekeeper and I am allergic to bees, and I know that OSHA should do that.

Mr. Norwood. You are not as smart as you look.

[Laughter.]

Mr. Hamilton. I have been desensitized.

Mr. Norwood. But the point here is whether we should consider regulating things like ragweed or bee stings or penicillin, and the list goes on forever. Should we consider those hazardous substances? Anybody?

Mr. Eberts. No.

Mr. Rose. I think they are substances that have concerns attached to them.

Mr. Norwood. They have hazards related to them.

Mr. Rose. And we try to speak to those hazards.

Mr. Norwood. If you wanted to send out your compliance officers to all the beekeepers, you couldn't do that anyway, could you? You don't have enough compliance officers to take care of all major safety problems in this country where people are being killed every day, so how are you going to send out your compliance officers to go into every beekeeper. I mean, from what you have said, you are going to educate these compliance officers, these latex cops, on what to do about rubber gloves, and they are going to spread the word across the world. But these associations have already covered much more territory than you ever will be able to cover.

Dr. Presson. We are happy that they have done that, but obviously our compliance officers wouldn't be getting questions from health care workers if all these areas had been covered.

Mr. Norwood. I am going to ask you to say that last part to me again, if you please. Repeat just what you said, please.

Dr. Presson. I said I am really happy that other educational efforts have been made by the professional organizations, as they should be. But if they had been able to reach all health care workers, we would not be getting the questions, and our compliance officers would not be getting questions regarding latex.

Mr. Norwood. Would you furnish this committee with a record of the questions you have been getting?

Dr. Presson. Yes, I will be happy to do that.

Mr. Norwood. Okay. I would appreciate that. They are beating on me about the red light, Mr. Roemer. Thank you, sir, and I recognize Mr. Roemer.

Mr. Roemer. Well, I am not sure I understand too much of the argument here. The American Hospital Association is concerned about this, and they are out there educating and informing people. The American Dentists Association is concerned about this. They admit there is a problem, and they are out there educating people. Dr. Reed says that there is a problem. Dr. Hamilton says there is a problem, although there is a discrepancy here as to how big the problem might be and the interpretation of the problem. Ms. Wilburn says that the American Nurses are very concerned about it.

We are out there educating a lot of people and informing a lot of people about it. Why shouldn't we inform our compliance officers in OSHA about it? I mean, if this is not a proposed regulation and you have jurisdiction over the workplace, something different from FDA; there are very different jurisdictions, although we have some overlap here, between FDA and OSHA. There are very different responsibilities that you have at OSHA in the workplace, too. And if there was information out there stating that there was something hazardous about working in a mine or a particular sweatshop or a particular environment, and there were questions about it, I hope that you would share that.

Now, do you see anything wrong with that statement?

Dr. Presson. I certainly think we should share the idea that there is a hazard, but also the recommendations of the scientific bodies and the experts in this country as to what needs to be done about it.

Mr. Roemer. And you are assuring this body and this committee again that this is a technical advisory information bulletin, and that is far from a draft proposed regulation, that is far from a proposed regulation. You haven't asked for any comment period for a regulation. You haven't put anything in the Federal Register on this. This is a technical advisory bulletin to your compliance officers. Is that correct?

Dr. Presson. Absolutely.

Mr. Roemer. So there is no regulatory impact on that?

Dr. Presson. No. It is not a regulation or a standard.

Mr. Roemer. So that doesn't even get posted in a small business. Do the compliance officers take this new information that you have sent them in terms of a potential hazard and are they instructed to take it to a dentist's office or to a workplace and post it on a bulletin board and warn people?

Dr. Presson. No, this isn't that_

Mr. Roemer. It just stays at an OSHA office, and it is only read by compliance people?

Dr. Presson. They may give it to an employee who asks them for it. There certainly would not be any posting. They could say this is what we have been informed are recommendations in the published literature and by scientific bodies in the country as ways to deal with this.

Mr. Roemer. When Chairman Norwood asked you the question about questions that you were receiving from other people, did you mean to say that you are receiving questions from your compliance people or people out there in the country that are calling compliance officers that are concerned about this as well? Is it both or one or the other?

Dr. Presson. It is both, but our response would be to the compliance officers. They are asking our compliance officers.

Mr. Roemer. All right. Ms. Wilburn, I was interested in your testimony when you said that in 1985 there were 20 requests for ID bracelets, and in 1997, I believe you said there were 10,000 requests for ID bracelets that cost $75 apiece.

Ms. Wilburn. Right.

Mr. Roemer. Is this part of the efforts that we have succeeded in and people getting more information out there to people that everybody at this table should be applauded for? Is this something that we need to do more information and education and not issue regulations on? What do you attribute this to? Do you think there is a growing problem? What is your interpretation of that data?

Ms. Wilburn. My interpretation is that there is a growing problem, and it was as of March 1999 that there were 10,000_

Mr. Roemer. So it was 1999, 10,000 requests.

Ms. Wilburn. Right. And people don't buy a Medic Alert bracelet unless they have a serious problem that, if unable to communicate to an emergency medical technician that comes to their home, the medical technician would not know how to treat them without using latex products that could make them sicker.

So the issue of fear being transmitted is, from my perspective, not an issue of spreading fear of the allergy. Rather, it is fear that people with the allergy have, who buy this medic Alert bracelet, when they can't breathe as a result of an exposure to something, it is frightening. It is frightening not to be able to breathe. It is not spreading fear about the risk. It is just the feelings that they have when they are exposed.

Mr. Roemer. Do they have to qualify scientifically? I mean, Dr. Reed said there is a specific way to diagnose those people scientifically. Do those people have to have that scientifically diagnosed allergy in order to qualify to get that and pay the $75?

Ms. Wilburn. No. It is voluntary.

Mr. Roemer. Voluntary. Okay.

Ms. Wilburn. It is important to get the information out about the different types of responses to gloves so we can have appropriate diagnosis and so that people are treated. And there are some reactions that if you use a synthetic glove, it might have the chemical that also causes that reaction, and this information is provided in the OSHA document.

Mr. Roemer. All right. Thank you, Ms. Wilburn.

Thank you, Mr. Chairman.

Mr. Eberts. Congressman, if you would like, I can follow up on your question and explain why this does have a regulatory effect.

Mr. Norwood. Mr. Eberts, why don't you do that on my time?

Mr. Roemer. He can do it. I am done.

Mr. Norwood. Yes, do it now since we are in this conversation.

Mr. Eberts. I think that is a very good question that has been asked. I operate in the real world, and I operate as a supplier to the employers who use these products, powdered gloves and powder-free gloves. Let me tell you a few things.

Compliance officers enforce compliance, and this does have a regulatory effect directly from OSHA. Under OSHA's General Duty Clause, the failure of an employer to follow a recommendation from OSHA, which, just as Congressman Roemer said, never had a notice period, never was published in the Federal Register, never had a hearing like this. Yet, employers can be cited for not following recommendations and information that is distributed to their technical staff.

Second point. The suggestion that this technical bulletin somehow gets distributed to some people within OSHA and nobody else sees it is frankly wrong, if not disingenuous. The draft has already been published on the Internet. State legislatures take the draft technical information bulletin for informing a compliance officer at OSHA and are proposing legislation based on it. The State of New York tried banning condoms based on this type of technical information bulletin. All glove products were going to be banned in the State of Nebraska. This has a tremendous regulatory effect.

At the American Academy of Allergy, Asthma and Immunology conference in Orlando just 2 weeks ago, a presentation based on the draft technical information bulletin, which supposedly has no enforcement effect, was given on OSHA enforcement actions. The presentation stated that OSHA considers this product a hazardous material and it will be enforced under the General Duty Clause.

As an attorney who deals with other hospital attorneys, I can tell you what the hospital attorneys and risk managers will do. They will look at that recommendation. They will say they do not want a compliance officer coming in and asking any questions, and so they will implement those OSHA recommendations. And the recommendations, as we pointed out in our written comments, have a very serious flaw. When it proposes using low-protein powdered gloves, some of the own data we submitted from the Mayo Clinic showed that some of those powder-free gloves that the OSHA recommendation would enforce are, in fact, higher in allergen levels than some powder-free gloves. So we may be unwittingly actually forcing some institutions at times to use more allergenic gloves for their patients.

Mr. Norwood. I got your full meaning, and that should have been my time.

[Pause.]

Mr. Norwood. The questions have only been partially asked, as you might well imagine, and I think we are going to have to conclude this hearing. But I promise you this committee won't conclude its work, and we are going to continue to ask all of you_

Mr. Roemer. Could I just make an inquiry, Mr. Chairman? We have a number of people that would like to get their testimony in that are latex allergy sufferers, and I am sure it is your intention to accommodate additional submissions.

Mr. Norwood. So ordered.

Mr. Roemer. How long will you keep the record open, Mr. Chairman?

Mr. Norwood. Ten days.

Mr. Roemer. I appreciate that, Mr. Chairman. Thank you.

Mr. Norwood. Ladies and gentlemen, we have to vote on the floor, so we will conclude our hearing. I want to conclude this by thanking all of you, and I hope that we have all come to recognize from this first hearing that there are conflicting views on this. No one is exactly right about how we should handle this problem. Or should we spend less time handling this problem and deal with other allergens that are more deadly and more frequent? That is a fair question to ask ourselves.

Chairman Hoekstra. Mr. Chairman?

Mr. Norwood. Mr. Hoekstra?

Chairman Hoekstra. Just having caught the last part of Mr. Eberts' comments, I think we also really need to get an answer on the impact of the General Duty Clause of OSHA.

Mr. Norwood. We will do that.

Chairman Hoekstra. We need to follow up on that.

Mr. Norwood. I think we all know the answer, though, which is why I don't want you to send your latex cops out. Because the minute you do, you scare the world to death. Personally, as a Member of Congress, I would vote very strongly to allow the Food and Drug Administration to handle this. It is their job to determine if a medical device is a hazard. It is not OSHA's job. I would rather you have gone to the FDA and insisted that they have latex gloves removed from the market based on it being a hazardous material rather than alerting the compliance officers out there that somebody might be doing something wrong.

So, with that, ladies and gentlemen, I thank you very much, and this record will be available to you because it is going to be a lot longer than just what we have said here.

Thank you all.

[Whereupon, at 4:20 p.m., the subcommittee was adjourned.]