[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Notices]
[Pages 47595-47596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number NIOSH-186]


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.

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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unpublished reports and findings from in vitro and in vivo toxicity 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)

[[Page 47596]]

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:
    <bullet> Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    <bullet> Facsimile: (513) 533-8285.
    <bullet> E-mail: <a href="/cdn-cgi/l/email-protection#97f9fef8e4fff3f8f4fcf2e3d7f4f3f4b9f0f8e1"><span class="__cf_email__" data-cfemail="7a14131509121e1519111f0e3a191e19541d150c">[email protected]</span></a>.
    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 (513) 533-8260.

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.
[FR Doc. E9-22299 Filed 9-15-09; 8:45 am]
BILLING CODE 4163-19-P


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