Docket Management
Docket: 98N-0359 - Program Priorities in the Center for Food Safety and Applied Nutrition
Comment Number: EC -8

Accepted - Volume 7

Comment Record
Commentor Ms. Regina Kellner Date/Time 2002-07-24 03:09:54
Organization National Latex Allergy Network
Category Individual

Comments for FDA General
Questions
1. General Comments DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0359] Please make latex allergy research and rule making a priority. Study and rule making is essential to address the current threat of food contamination by natural rubber latex. Many allergens are a serious threat. The scientific community newly recognizes natural rubber latex allergens in food. However, it is not a new problem for those affected by natural rubber latex allergy. People affected by latex allergy have had trouble breathing, swallowing, hives and other symptoms due to their exposure to natural rubber latex in their food. How many people have died due to anaphylaxis to contaminated food? People affected by the allergy do their best to ask about their food and how it is handled and processed. It is a daunting task to find safe groceries, restaurants and other food sources. It is especially difficult for children to avoid disaster. Children are often offered food in public areas that may cause severe allergic responses. Natural rubber latex is a microscopic contaminant. A child with a peanut allergy can eliminate the obvious peanut butter cookie. A child allergic to latex will not be able to detect which foods to avoid. Most citizens do not have the opportunity to grow and process their own food. We rely on the careful preparation of food by other people. Eliminating latex gloves in food preparation and processing would be an easy remedy for a severe health consequence with life long implications. Latex gloves are not necessary for biohazard protection in food service. Alternative materials other than latex will prevent the development of latex disease for workers and consumers. Aleman, A. Satre, J. Journal of Allergy and Clinical Immunology, January 2002, part 2, Volume 109, Number 1.Madrid, Spain 870 Double-Blind, Placebo-Controlled, Oral Challenge Study With Latex Glove Extract in Patients Allergic to Natural Rubber Latex C De Castro Santiago Quirce M Fernández-Nieto A Alemán Joaquín Sastre Fundación Jiménez Díaz, Madrid, Spain Allergic reactions to natural rubber latex (NRL) may occur after ingestion of latex contaminated foodstuffs. It has been shown by immunologic methods that latex proteins can be transferred to food following contact with latex gloves. The goal of this study was to assess whether latex-contaminated food can provoke allergic symptoms in patients sensitized to NRL. An extract of NRL gloves was prepared at 10% w/v. Thirty 1-cm2 freshly-cut glove pieces (500 mg total weight) were stirred for 30 min in 5 ml of sterile normal saline, finally it was passed through a 0.22 µm filter. Six health care workers (range age 24-34 years old) allergic to NRL were recruited from our hospital. All of them suffered from rhinitis and contact urticaria with NRL gloves and four of them had latex-induced asthma. They all had a positive skin test with NRL extract (20 µg/ml protein, ALK-Abelló, Spain) and specific IgE to NRL (Pharmacia, Sweden). A double-blind, placebo-controlled, oral challenge with latex glove extract was carried out. At 30-minute intervals, the subjects received 10 ml of sugar-water solution as placebo, followed by 0.2 and 0.5 ml of the aqueous solution with increasing concentrations (0.01, 0.1, 1 and 10% w/v) of NRL glove extract. Three patients (50%) showed a positive DBPCOC test, whereas none of the 4 control subjects reacted to this challenge. All of the patients who experienced a positive response to DBPCOC had asthma due to latex, and two of them had food allergic symptoms with fruits (oral allergy syndrome to kiwi and anaphylaxis to banana, respectively). Five of the patients had positive skin tests with fruits (banana, avocado, chestnut and kiwi), but only two patients had allergic symptoms when eating them. These data point out that the intake of NRL-contaminated food by sensitized patients may elicit allergic symptoms. Thus, as part of the latex avoidance measures, we suggest that patients allergic to NRL should be warn about avoiding the ingestion of foodstuffs which have been handled or processed by personnel wearing NRL gloves. Allergy Asthma Proc 2000 Sep-Oct;21(5):301-6 Related Articles, Books, LinkOut Latex protein: a hidden food allergen? Beezhold DH, Reschke JE, Allen JH, Kostyal DA, Sussman GL. Laboratory of Immunobiology, Guthrie Research Institute, Sayre, Pennsylvania 18840, USA. Avoidance of latex allergens is the primary method to prevent adverse reactions. Natural rubber latex is found in many different products in both the health care industry and in modern society, and consequently results in unexpected exposures of sensitized individuals. The use of latex gloves by food handlers provides one potential route for inadvertent exposure to latex allergens. In this study we have used two immunological methods to determine whether latex proteins are transferred to foods following contact with latex gloves. Direct transfer of latex protein to cheese was visualized using a modified immunoblot method. Sliced cheese was touched with a gloved finger. A nitrocellulose membrane was applied to lift the potential fingerprints and a rabbit anti-latex antiserum was used to visualize the transfer of any latex finger-prints. After handling lettuce with gloves, transferred protein was recovered by extracting the lettuce and quantified using an inhibition ELISA for latex proteins. Fingerprints of latex protein were readily detectable on cheese after contact with powdered latex gloves, but not with vinyl gloves. Furthermore, powdered latex glove use resulted in measurable amounts of latex protein on lettuce with an exposure-dependent increase in the latex protein levels. Lettuce alone or lettuce handled with vinyl gloves was negative for latex protein. The use of latex gloves by food handlers is the source of an indirect food additive in the form of latex proteins. It is recommended that food handlers avoid the use of latex gloves to eliminate inadvertent exposure of latex-sensitive individuals.




EC -8