Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Notices 47595 

personnel, shipping and receiving 

personnel, waste handlers, 

maintenance, housekeeping, and 

laundry workers, and workers in 

veterinary practices who may come into 

contact with drugs or drug waste. Health 

care workers may be exposed to 

hazardous drugs when they compound, 

administer, or dispose of hazardous 

drugs, clean up spills, or touch surfaces 

that are contaminated with these drugs. 

These activities frequently create 

aerosols or generate dust, thus 

increasing the risk of exposure [NIOSH 

2004]. Skin absorption and inhalation 

are the most likely routes of exposure 

for a health care worker. However, 

ingestion (from hand to mouth) or 

injection through a needle stick or 

sharps injury is possible. 

When other types of controls, such as 

engineering controls and the use of 

personal protective equipment do not 

eliminate exposure to hazardous drugs, 

alternative duty or re-assignment away 

from the potential hazard is a type of 

administrative control that will help 

protect the workers and their offspring 

from the potential adverse reproductive 

effects of hazardous drugs [Saiki et al. 

1994; ACOEM 1996; HSE 2003]. 

NIOSH seeks to obtain materials, 

including published and unpublished 

reports and research findings, to 

evaluate mechanisms for alternative 

duty and administrative controls and 

possible reproductive health risks of 

occupational exposure to hazardous 

drugs. Examples of requested 

information include, but are not limited 

to, the following: 

(1) Trends in production and use of 

hazardous drugs over the past 10 years. 

(2) Descriptions of procedures with a 

potential for exposure to hazardous 

drugs. 

(3) Identification of industries or 

occupations in which exposures to 

hazardous drugs may occur. 

(4) Case reports or other health data 

that investigate possible adverse 

reproductive health effects in workers 

exposed to hazardous drugs or related 

animal data (published or peer-reviewed 

data are preferred). 

(5) Descriptions of work practices and 

engineering controls, including costs 

and effectiveness of control measures 

being taken, to reduce or prevent 

workplace exposure to these drugs. 

(6) Educational materials for worker 

safety or training on the safe handling 

of hazardous drugs. 

(7) Guidelines and/or 

recommendations for alternative 

duty/temporary reassignment policies 

in the health care or other industries 

where exposures cannot be controlled 

by conventional methods (engineering 

controls etc). 

(8) Data pertaining to the need for 

alternative duty to limit occupational 

exposures to hazardous drugs for 

couples who are tying to conceive, and 

women who are pregnant or 

breastfeeding. 

(9) Data pertaining to the feasibility of 

these types of recommendations, 

including actual or projected costs of 

alternative duty/temporary 

reassignment strategies considered. 

NIOSH will use this information to 

determine the need for developing 

recommendations for alternative duty/ 

temporary reassignment for individuals 

who may be at reproductive risk and/or 

whose fetus or offspring may be at risk 

from exposure to these drugs. 

References: 

ACOEM (American College of 

Occupational and Environmental 

Medicine) [1996]. Committee report: 

ACOEM reproductive hazard 

management guidelines. JOEM 38(1):83– 

90. 

ASHP [2006]. ASHP guidelines on 

handling hazardous drugs. Am J HealthSyst Pharm 63:1172–1193. 

BLS [2007]. National IndustrySpecific Occupational Employment and 

Wage Estimates from BLS, May 2007 

[http://www.bls.gov/oes/current/ 

naics2_62.htm#(1)]. 

Briggs GG, Freeman RK, and Yaffee SJ 

ed. Drugs in Pregnancy and Lactation, 

7th ed. Lippincott, Williams and 

Wilkins. Philadelphia, 2005. 

Dranitsaris G, Johnston M, Poirier S, 

Schueller T, Milliken D, Green E, Zanke 

B [2005]. Are health care providers who 

work with cancer drugs at an increased 

risk for toxic events? A systematic 

review and meta-analysis of the 

literature. J Oncol Pharm Practice 

11:69–78. 

HSE (Health and Safety Executive) 

[2003]. HSE Leaflet. New and expectant 

mothers at work; a guide to health 

professionals. Available at: http:// 

www.hse.gov.uk/pubns/indg373hp.pdf. 

McInnes S, Schilsky RL [1996]. 

Infertility following cancer 

chemotherapy. In: Chabner BA, Longo 

DL, eds. Cancer Chemotherapy and 

Biotherapy: Principles and Practice. 2nd 

ed. Philadelphia, PA: Lippincott-Raven, 

pp. 31–44. 

NIOSH [2004]. NIOSH Alert: 

preventing occupational exposures to 

antineoplastic and other hazardous 

drugs in health care settings. Cincinnati, 

OH: U.S. Department of Health and 

Human Services, Public Health Service, 

Centers for Disease Control and 

Prevention, National Institute for 

Occupational Safety and Health, DHHS 

(NIOSH) Publication No. 2004–165. 

OSHA [1999]. Categorization of drugs 

as hazardous. In: OSHA technical 

manual, TED 1–0.15A, Sec VI, Chapter 

II. Washington, DC: U.S. Department of 

Labor, Occupational Safety and Health 

Administration [http://www.osha.gov/ 

dts/osta/otm/otm_vi/otm_vi_2.html#2]. 

Saiki CL, Gold EB, Schenker MB 

[1994]. Workplace policy on hazards to 

reproductive health. In: Gold EB, Laskey 

BL, Schenker MB, eds. Occupational 

Medicine: State of the Art Reviews. Vol 

9. Philadelphia, PA: Hanley & Belfus, 

Inc, pp. 541–549. 

Timpe EM, Motl SE [2004]. 

Environmental exposure of health care 

workers to category D and X 

medications. Am J Health-Syst Pharm 

61:1556–1561. 

Dated: September 9, 2009. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. E9–22275 Filed 9–15–09; 8:45 am] 

BILLING CODE 4163–19–P 

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. 

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) 


srobinson on DSKHWCL6B1PROD with NOTICES
47596 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Notices 

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: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1857– 

DR; Docket ID FEMA–2008–0018] 

New York; Amendment No. 2 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

State of New York (FEMA–1857–DR), 

dated September 1, 2009, and related 

determinations. 

DATES: Effective Date: September 10, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Disaster Assistance 

Directorate, Federal Emergency 

Management Agency, 500 C Street, SW., 

Washington, DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: The notice 

of a major disaster declaration for the 

State of New York is hereby amended to 

include the following areas among those 

areas determined to have been adversely 

affected by the event declared a major 

disaster by the President in his 

declaration of September 1, 2009. 

Chenango and Cortland Counties for 

Public Assistance 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 


srobinson on DSKHWCL6B1PROD with NOTICES