E9-22299. Request for Information on Glutaraldehyde

AGENCY:

National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice of public comment period.

SUMMARY:

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on glutaraldehyde, and develop appropriate communication documents, such as a Criteria Document, which will convey the potential health risks, recommended measures for safe handling, and establish an updated Recommended Exposure Limit (REL) for glutaraldehyde. The current NIOSH REL for glutaraldehyde is 0.2 ppm as a ceiling limit.

NIOSH is requesting information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with glutaraldehyde, (2) information on possible health effects observed in workers exposed to glutaraldehyde, (3) information on workplaces and products in which glutaraldehyde can be found, (4) description of work tasks and scenarios with a potential for exposure to glutaraldehyde, (5) workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to glutaraldehyde occur.

Public Comment Period: Comments must be received by December 14, 2009.

ADDRESSES:

You may submit comments, identified by docket number NIOSH-186, by any of the following methods:

• Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
• Facsimile: [phone].
• E-mail: [e-mail].

All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. A complete electronic docket containing all comments submitted will be available on the NIOSH Web page at http://www.cdc.gov/​niosh/​docket, and comments will be available in writing by request. NIOSH includes all comments received without change in the docket, including any personal information provided.

FOR FURTHER INFORMATION CONTACT:

T.J. Lentz, NIOSH, Robert A. Taft Laboratories, MS-C32, 4676 Columbia Parkway, Cincinnati, OH 45226, telephone [phone].

SUPPLEMENTARY INFORMATION:

Glutaraldehyde is also known as glutaral, glutardialdehyde, glutaric aldehyde, pentanedial, and 1,5-pentanedione. It is a colorless, oily liquid with a pungent odor. It is soluble in water, alcohol, and ether; and is often used in a diluted form ranging in strength from 1 to 50%. Glutaraldehyde is used as a cold sterilant to disinfect medical, surgical, and dental equipment. It has also been used as an antimicrobial in water treatment systems, in leather tanning agents, in embalming fluids, as a biocide in metalworking fluids, as a slimicide in paper manufacturing, as a preservative in cosmetics, as a disinfectant in animal housing, and as a tissue fixative.

Occupational exposure may occur by inhalation and dermal contact. Glutaraldehyde can act as an irritant of the eyes, nose, and throat; and can cause contact and/or allergic dermatitis, asthma, and difficulty breathing. The current REL for glutaraldehyde (0.2 ppm as a ceiling limit) was adopted on the basis of NIOSH comments to the Occupational Safety and Health Administration (OSHA) on the Air Contaminants Standard [54 FR 2329-2984 (1989)]. In 1991, NIOSH published a Current Intelligence Bulletin on aldehydes [DHHS (NIOSH) Publication No. 91-112] which classified acetaldehyde and malonaldehyde as occupational carcinogens and identified glutaraldehyde as a mutagen. Because the carcinogenic potential of related aldehydes had not been adequately evaluated, NIOSH recommended that careful consideration be given to reducing exposures to related aldehydes, including glutaraldehyde. OSHA has no permissible exposure limit (PEL) for glutaraldehyde. The American Conference of Governmental Hygienists (ACGIH) threshold limit value (TLV) for glutaraldehyde is 0.05 ppm as a ceiling limit. In 2001 NIOSH published a brochure about the occupational health effects of glutaraldehyde exposure in hospitals [DHHS (NIOSH) Publication no. 2001-115].

NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible health risks of occupational exposure to glutaraldehyde. Examples of requested information include, but are not limited to, the following:

(1) Identification of industries or occupations in which exposures to glutaraldehyde may occur.

(2) Trends in the production and use of glutaraldehyde.

(3) Description of work tasks and scenarios with a potential for exposure to glutaraldehyde.

(4) Workplace exposure measurement data in various types of industries and jobs.

(5) Case reports or other health information demonstrating potential health effects in workers exposed to glutaraldehyde.

(6) Research findings from in vitro and in vivo studies.

(7) Information on controls (e.g., engineering controls, work practices, PPE) including costs and effectiveness of control measures being taken to minimize worker exposure to glutaraldehyde.

(8) Educational materials for worker safety and training on the safe handling of glutaraldehyde.

(9) Data pertaining to the feasibility of establishing a more protective REL for glutaraldehyde including projected costs of control strategies considered.

(10) Names of substitute chemicals or processes being used in place of glutaraldehyde and type of work tasks.

Dated: September 9, 2009.

John Howard,

Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.