Your ACTION is needed!

July 31, 2003

7-30-03

Your Action is Needed!

There are two issues under consideration that are important to Natural Rubber Latex Allergy.

1. The proposed wording for ASTM standards to place restrictions on the
coloring of natural rubber latex and synthetic gloves
2. The proposed prohibition of latex gloves from food services

To submit written comments on these topics please use the Addresses listed below.

The ASTM International is a non-profit organization that provides a forum for the development and publication of voluntary consensus standards for materials, products, systems and services. It is made up of more than 20,000 members representing producers, users ultimate consumers, and representatives of government and academia. The documents they develop serve as a basis for manufacturing, procurement and regulatory activities.
For more information on the ASTM see: www.astm.org

The ASTM is currently in the color proposal draft process. The standardization of glove colors could improve patient and employee safety and prevent possible errors due to
look-a-like gloves.

The American Latex Allergy Association strongly urges its members and those interested in natural rubber latex allergy to write letters of support for this important safety issue.

1. Color (proposed draft)
ASTM is discussing whether to include restrictions on glove colors in upcoming revisions of medical glove standards. Color restrictions would allow individuals to distinguish between latex and synthetic gloves.

X.X. To facilitate the rapid identification of natural
rubber latex gloves by those who must avoid their
use due to latex allergy, glove coloration
should be restricted as follows:
X.X.1. Natural rubber latex glove coloration shall
be limited to the buff, beige and tan tones reflective
of their historical appearance. This limitation also
applies to natural rubber latex/synthetic blends.
Alternatively, the presence of latex may be
distinguished by so designating on each individual
glove.
X.X.2. Synthetic gloves must be readily
distinguished from natural rubber latex
by limiting their finished appearance to
colors other than the buff, beige or tan
tones. Alternatively, gloves may be distinguished
by identifying "synthetic" or the base material
composition (e.g. vinyl) on each individual glove.

2. Food Handling (proposed draft)
Discussions are currently being held as to whether natural rubber latex gloves should be restricted from use in food services. It is proposed that the new ASTM standard on gloves for use in food services shall contain wording similar to the following:

It has been demonstrated that allergens can be transferred to foods when natural rubber latex gloves are worn during food preparation. To avoid the risk of reactions by latex allergic individuals who consume such foods, latex gloves shall be prohibited from use in the preparation or handling of foods.

For more information see:
www.fda.gov
www.fda.gov/cdrh
www.cfsan.fda.gov
www.foodsafety.gov

Individuals, who wish to express their opinions, provide additional data or relate patient or employee experiences relevant to either or both of these topics may address their comments to:

Addresses

FDA:
Dr. David W Feigal HFZ-001
Director CDRH
FDA
9200 Corporate Blvd.
Rockville MD 20850
301-827-7975
dwf@cdrh.fda.gov

Dr. Chiu Lin HFZ- 420
Chief Device Evaluations
FDA
9200 Corporate Blvd.
Rockville MD 20850
301-443-8913
cxl@cdrh.fda.gov

(Food only): Joseph A. Levitt Esq
Director, FDA
Food Safety and Applied Nutrition
200 C Street, S.W.
Room 6815
Washington, DC 20204
301-436-1600
joseph.levitt@cfsan.fda.gov

OSHA:
Dr. Richard Fairfax, Director
Directorate of Enforcement Program
DOL/OSHA
200 Constitution Ave. NW
Washington DC 20210
202-693-2100

NIOSH:
Dr. Al Munson, Director
NIOSH
Mail Stop 020
1095 Willowdale Road
Morgantown WV 26505-2845
304-285-6121
akm5@cdc.gov

Don Beezhold, Toxicologist
NIOSH
Mail Stop 020
1095 Willowdale Road
Morgantown WV 26505-2845
304-285-5720
zec1@cdc.gov

ASTM:
Kok-Kee Hon
ASTM Chairman D11
6324 Meetinghouse Way
Alexandria, VA 22312 1718
KKHON@aol.com

Wava Truscott, Ph.D.
Director, Scientific Affairs & Clinical Education
Kimberly-Clark Health Care
1400 Holcomb Bridge Rd 200/5
Roswell, GA 30076
770-587-8447
wtruscott@kcc.com