1. IntroductionIntroduction Allergic Reactions to Latex Are Real. A Greater Concern Is Unrealistic Fear. The unwarranted fear Is disabling The fear is based on misunderstanding of medical terms and continues despite the absence of scientific evidence supporting the fear. The Ban Proposed Will Only Serve to Increase Patients’ Disability From The Unrealistic Fear.

2. Latex as a “Food” Allergen Allergic reactions have occurred from exposures at work, at home or during medical examinations or surgery. However in 2003 the major problem of allergy to latex is no longer these allergic reactions. It is an unrealistic fear of allergy.

3. Unrealistic Fear of Allergy “Health care workers are at the highest risk of a clinical allergic emergency from exposure to high allergen powdered latex gloves. To our knowledge, no other disease has had greater direct effect on these providers. With the findings that 17% of health care workers in one U.S. hospital were sensitized and 36% of atopic health care workers in one French study were sensitized, no greater threat exists to the careers and potentially the lives of health care workers.” Kelly, K.J., Walsh-Kelly, C.M., Latex Allergy: A Patient and Health Care System Emergency, Journal of Emergency Nursing, 1998; 24:539A5.

4. Unrealistic Fear of Allergy “Sensitization” means detectable IgE antibody. It does not mean allergic disease. Only about half of individuals with IgE antibody have disease. Douglas R, Morton J, Czarny D, O'Hehir RE. Prevalence of IgE-mediated allergy to latex in hospital nursing staff. Australian & New Zealand Journal of Medicine 1997; 27:165-169. Meeropol E, Leger R, Frost J. Latex allergy in patients with myelodysplasia and in health care providers: a double jeopardy. Urologic Nursing 1993; 13:34-44. Meeropol E, Leger R, Frost J. Latex allergy in patients with myelodysplasia and in health care providers: a double jeopardy. Urologic Nursing 1993; 13:34-44. Novembre E, Bernardini R, Brizzi I, et al. The prevalence of latex allergy in children seen in a university hospital allergy clinic. European Journal of Allergy & Clinical Immunology. 1997; 52:101-105. Novembre E, Bernardini R, Brizzi I, et al. The prevalence of latex allergy in children seen in a university hospital allergy clinic. European Journal of Allergy & Clinical Immunology. 1997; 52:101-105. Liss GM, Sussman GL, Deal K, et al. Latex allergy: epidemiological study of 1351 hospital workers. Occupadonal & Environmental Medicine 1997; 54:335-342. Liss GM, Sussman GL, Deal K, et al. Latex allergy: epidemiological study of 1351 hospital workers. Occupadonal & Environmental Medicine 1997; 54:335-342.

5. Occupational allergy to latex is actually not as severe as many other occupational allergies. Of 1258 reported cases of latex allergy in hospital staff only two had severe systemic reactions. None to oral ingestion. When the exposure is appropriately controlled, which does not require complete removal of latex gloves, health care workers with allergic disease to latex can work without symptoms. Occupational allergy to latex is actually not as severe as many other occupational allergies. Of 1258 reported cases of latex allergy in hospital staff only two had severe systemic reactions. None to oral ingestion. When the exposure is appropriately controlled, which does not require complete removal of latex gloves, health care workers with allergic disease to latex can work without symptoms. Unrealistic Fear of Allergy

6. The fear is anaphylaxis. “Anaphylaxis” is often used ambiguously and imprecisely. As a consequence the significance of mild allergic reactions tends to be overstated. No true anaphylactic reactions have been reported from oral ingestion of rubber allergens.

7. Anaphylaxis Definition Widespread explosive release of mast cell mediators causing three or more of the following Flush, urticaria, angioedemaFlush, urticaria, angioedema HypotensionHypotension Airway obstruction, laryngeal and bronchialAirway obstruction, laryngeal and bronchial ArrythmiaArrythmia Loss of consciousnessLoss of consciousness Abdominal pain, diarrhea, vomitingAbdominal pain, diarrhea, vomiting Ideally confirmed by elevated serum mast cell tryptase

8. Dose-Response Considerations Allergic reactions occur at the site of contact. The severity of an immediate allergic reaction is the result of three variables: the amount of allergen, the amount of IgE antibody, and the biological response to the mediators from mast cells generated by allergen-antibody combination. Like all biological reactions the dose-response curve of mast cells to allergens is S shaped. Reactions from trivial amounts of allergen are trivial.

10. Quantitative consideration of transfer of latex allergens from gloves to food. There is no scientific evidence demonstrating that a clinically significant amount of allergen can be transferred from a glove to food. The evidence necessary to support the proposed ban, therefore, is not supported by valid science.

11. Quantitative consideration of transfer of latex allergens from gloves to food. From a high allergen glove worn inside out transfer was 55 ng per finger contact. With currently approved gloves worn with the antigen carrying surface inside transfer would be in the range of 1 ng per finger contact. Beezold DH, Reschkin JE, Allen,JH, Koystal DA, Sussman GL. Latex protein: a hidden “food” allergen? Allergy and Asthma Proceedings 2000: 21; 301-306.

12. Quantitative consideration of transfer of latex allergens from gloves to food. Assuming that under exceptional circumstances as much as 10 ng might be ingested, the protein allergen is subject to degradation by stomach acid and intestinal proteases. The amount remaining to enter the circulation is unknown. Assuming half is absorbed it would be diluted in the blood and body fluids. Maximum concentration in the tissues would be at the bottom of the S shaped dose-response curve, and not clinically significant.

13. Threshold Doses of Peanut Allergens 26 subjects.26 subjects. Prospective double blind challenge with increasing doses of peanut protein, 30 μg to 1 gm.Prospective double blind challenge with increasing doses of peanut protein, 30 μg to 1 gm. Subjective symptoms of in all 26. (oral allergy syndrome) Dose: 100 μg to 1 gm.Subjective symptoms of in all 26. (oral allergy syndrome) Dose: 100 μg to 1 gm. Objective response in 6. No change in FEV 1 or BP.Objective response in 6. No change in FEV 1 or BP. –Lip swelling in 3 Dose 0.1 to 10 mg –Laryngeal edema in 2. Dose 0.3-1 mg –Vomiting in 2 Dose 1 –10 mg Wensing et al. The distribution of individual threshold doses eliciting allergic reactions in a population with peanut allergy. Journal of Allergy and Clinical Immunology 2002;110:915-20

14. Threshold Doses of Food Allergens Taylor et al. Journal of Allergy and Clinical Immunology 2002;109:24-30. Taylor et al. Journal of Allergy and Clinical Immunology 2002;109:24-30. FOODDOSE of PROTEIN FOODDOSE of PROTEIN Peanut0.2-125 mg Egg0.1-200 mg Milk0.6-180 mg Mustard0.3 mg Fish5mg-6 gm (Food)

15. ConclusionsConclusions There is no proof that doses of allergen that might be transferred from gloves to food cause systemic allergic reactions.There is no proof that doses of allergen that might be transferred from gloves to food cause systemic allergic reactions. Threshold doses of known allergenic foods range from 0.1 to 200 mg. This is of the order of a thousand fold more than would be transferred from gloves.Threshold doses of known allergenic foods range from 0.1 to 200 mg. This is of the order of a thousand fold more than would be transferred from gloves. A ban on rubber gloves in the food industry will fuel the existing unrealistic fear.A ban on rubber gloves in the food industry will fuel the existing unrealistic fear.