| Comment Record|
Mrs. Ann Marie Collington ||
2001-09-17 22:56:24 |
National Latex Allergy Network |
Health Professional |
| Comments for FDA General |
1. General Comments
September 17, 2001
Dockets Management Branch (HFA-305)
Food & Drug Administration
5630 Fisher's Lane, Rm 1061
Rockville, Maryland 20852
Re: Docket No. 98N-0359
Dear FDA Representative;
I am writing in response to the request for comments regarding Program Priorities in the Center for Food Safety and Applied Nutrition [Docket No. 98N-0359], for FY 2002 regarding planning, budgeting, resource allocation process and work product expectations.
There has been research and documentation in recent years noting the increased prevalence of natural rubber (NR) latex allergy due to the use of powdered latex gloves made of hevea natural rubber. The use of NR latex gloves in many industries has increased dramatically over the past 20 years. I am asking that the FDA allocate resources to establish regulations, which will eliminate natural rubber latex gloves in the food industry. This year several states passed legislation banning the use of latex gloves in food preparation (i.e. Arizona, Rhode Island), this was in response to research which has documented that latex proteins from the gloves are transferred onto the food handled by those wearing latex gloves. The latex proteins are an unsafe food additive and a pose a threat to individuals who are allergic to natural rubber latex and those at risk for the allergy.
The use of latex gloves in food establishments has been overwhelming. OSHA(Occupational Safety & Health Administration) does not regulate the use of latex gloves in food preparation, recognizing that natural rubber latex glove use in food establishments is inappropriate glove use.
While there are many things that cause allergic reactions, life-threatening reactions can occur from the latex proteins contained in the latex gloves, with any food, utensils, plates and surfaces prepared or cleaned by an employee wearing natural rubber latex gloves. Along with the good old-fashioned handwashing, there are many safe, non-latex glove alternatives (such as plastic, vinyl, nitrile)which can be safely used for food preparation. Plastic, vinyl, nitrile and many other synthetic non-latex gloves are available.
Another consideration is the employee wearing latex gloves. People typically become sensitized to latex proteins through the continued low dose exposure, which employees are being subjected to, when they are required to wear them regularly. The incidence of latex allergy is increasing at an alarming rate; many doctors, dentists, nurses and other healthcare workers have lost their careers because of exposure to latex gloves on a regular basis. Please keep in mind that the largest population of latex allergic individuals are children with a condition called spina bifida. These are the most helpless and innocent victims of this allergy.
The National Institute for Occupational Safety and Health in 1997 issued an alert warning employers of the hazards of natural rubber latex gloves in the workplace. The FDA is more than aware of latex allergy addressing it with the requirement of medical device labeling which started in September 1998. However, the gloves handled in food service are not regulated. In 1999, OSHA issued a Technical Information bulletin noting the hazards of natural rubber latex gloves and the potential for latex allergy.
I ask the FDA to address this health hazard by amending the existing regulation to exclude all natural rubber latex gloves, in any aspect of the food industry, from farm to table. Since the Center for Food Safety and Applied Nutrition has allergens listed as an emerging area to be addressed, I would like to recommend that for the safety of millions of Americans with Latex Allergy, that this be a priority for 2002.
Thank you for your time and consideration of this public health issue.
Ann Marie Collington, RN, BSN