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Notice

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

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Information about this document as published in the Federal Register.

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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 Start Printed Page 8860the 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.

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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.

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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.

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Dated: February 14, 2006.

Alvin Hall,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.

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[FR Doc. 06-1542 Filed 2-17-06; 8:45 am]

BILLING CODE 4163-18-P