[Federal Register Volume 71, Number 34 (Tuesday, February 21, 2006)]
[Notices]
[Pages 8859-8860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1542]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Request for Information on Waste Halogenated Anesthetic Agents: 
Isoflurane, Desflurane, and Sevoflurane

SUMMARY: NIOSH intends to review and evaluate toxicity data for the 
halogenated anesthetic agents of isoflurane, desflurane, and 
sevoflurane.
    The current NIOSH recommended exposure limit (REL) of 2 parts per 
million (ppm) as a 60-minute ceiling for

[[Page 8860]]

the halogenated gases (chloroform, trichloroethylene, halothane, 
methoxyflurane, fluroxene, and enflurane) was established in 1977 
[NIOSH 1977]. The halogenated anesthetic agents, isoflurane, 
desflurane, and sevoflurane, were subsequently introduced and are not 
included in the 1977 NIOSH recommendation. Isoflurane, desflurane, and 
sevoflurane are commonly used for anesthesia in modern hospitals; 
however, no occupational exposure limits exist for these agents. NIOSH 
is requesting: (1) Comments and information relevant to the evaluation 
of health risks associated with occupational exposure to isoflurane, 
desflurane, and sevoflurane, (2) reports or other data that demonstrate 
adverse health effects in workers exposed to isoflurane, desflurane, 
and sevoflurane, and (3) information pertinent to establishing a REL 
for isoflurane, desflurane, and sevoflurane.

ADDRESSES: Comments should be transmitted to the NIOSH Docket Office, 
M/S C-34, Robert A. Taft Laboratories, 4676 Columbia Parkway, 
Cincinnati, Ohio 45226, telephone 513/533-8303, fax: 513/533-8285.
    Comments may also be submitted directly through the Web site 
(http://www.cdc.gov/niosh/review/public/Waste-Anesthetic-Gases/), by e-
mail to nioshdocket@cdc.gov, or by fax to 513/533-8285. E-mail 
attachments should be formatted as Microsoft Word. Comments concerning 
this notice must be received on or before April 18, 2006 and should 
reference docket number NIOSH-064.
    All information received in response to this notice will be 
available for public examination and copying at the NIOSH Docket 
Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

FOR FURTHER INFORMATION CONTACT: Henryka Nagy, Ph.D., M/S C-32, Robert 
A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226, 
telephone 513/533-8369, e-mail HUB1@cdc.gov.

SUPPLEMENTARY INFORMATION: During patient anesthetization, small 
amounts of anesthetic gases can escape from the anesthetic delivery 
system and the patient's respiratory system. Waste anesthetic gases may 
become a source of harmful exposures for operating room personnel.
    Anesthesiologists, veterinarians, dentists, anesthetic nurses, 
operating room nurses, surgeons, operating room technicians, and other 
operating room personnel are at risk of exposure to waste anesthetic 
gases. A concern about harm to the reproductive system, central nervous 
system, liver, and kidneys prompted NIOSH to develop RELs for waste 
anesthetic gases [NIOSH 1977]. In 1977, the current NIOSH REL of 2 
parts per million (ppm) as a 60-minute ceiling was established for the 
halogenated gases chloroform, trichloroethylene, halothane, 
methoxyflurane, fluroxene, and enflurane [NIOSH 1977]. Isoflurane, 
desflurane, and sevoflurane were subsequently introduced and are not 
included in the 1977 NIOSH recommendation.
    NIOSH has not yet developed RELs for isoflurane, desflurane, and 
sevoflurane. Furthermore, the Occupational Safety and Health 
Administration (OSHA) has no permissible exposure limits (PELs) for 
these agents. The Netherlands' 1998 Dutch Expert Committee on 
Occupational Standards (DECOS) derived an occupational exposure limit 
of 20 ppm for enflurane on the basis of reproductive toxicologic data 
[DECOS 1998]. For isoflurane (an isomer of enflurane), DECOS also 
recommended an occupational exposure limit of 20 ppm on the basis of 
assumed structure-related activity [DECOS 1998]. No epidemiologic 
studies are available on the health effects of the halogenated agents, 
isoflurane, desflurane, and sevoflurane.
    NIOSH seeks to obtain materials, including published and 
unpublished reports and research findings, to evaluate the possible 
health risks of occupational exposure to these gases. Examples of 
requested information include, but are not limited to, the following: 
(1) Identification of industries or occupations in which exposures to 
isoflurane, desflurane, or sevoflurane may occur; (2) trends in 
production and use of isoflurane, desflurane, or sevoflurane over the 
past 10 years; (3) descriptions of procedures with a potential for 
exposure to isoflurane, desflurane, or sevoflurane; (4) current 
occupational exposure concentrations of isoflurane, desflurane, or 
sevoflurane in various types of occupational scenarios and, if 
available, data to document these concentrations (5) case reports or 
other health data that demonstrate adverse health effects in workers 
exposed to isoflurane, desflurane, or sevoflurane, or animal data 
(published or peer-reviewed data are preferred); (6) descriptions of 
work practices and engineering controls used to reduce or prevent 
workplace exposure; (7) educational materials for worker safety or 
training on the safe handling of these halogenated agents; (8) data 
pertaining to the technical feasibility of establishing a more 
protective REL for isoflurane, desflurane, and sevoflurane.
    NIOSH will use this information to determine the need for 
developing recommendations for reducing occupational exposure to 
isoflurane, desflurane, and sevoflurane.
    References: DECOS [1998]. Enflurane, isoflurane and cyclopropane: 
health-based recommended occupational exposure limits. Report of the 
Dutch Expert Committee on Occupational Standards, a committee of the 
Health Council of the Netherlands.
    NIOSH [1977]. Criteria for a recommended standard * * * 
occupational exposure to waste anesthetic gases and vapors. Cincinnati, 
OH: U.S. Department of Health, Education, and Welfare, Public Health 
Service, Center for Disease Control, National Institute for 
Occupational Safety and Health, DHEW (NIOSH) Publication No. 77-140.
    The Director, Management Analysis and Services Office has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of meetings and other committee management activities for 
both CDC and the Agency for Toxic Substances and Disease Registry.

    Dated: February 14, 2006.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 06-1542 Filed 2-17-06; 8:45 am]
BILLING CODE 4163-18-P