47594 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Notices 

(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 1– 

BP. 

(6) Research findings from in vitro and 

in vivo toxicity 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 1–BP. 

(8) Educational materials for worker 

safety and training on the safe handling 

of 1–BP. 

(9) Data pertaining to the feasibility of 

establishing a more protective REL for 

1–BP including projected costs of 

control strategies considered. 

(10) Names of substitute chemicals or 

processes being used in place of 1–BP 

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. E9–22297 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–150] 

Request for Information on Alternative 

Duty: Temporary Reassignment for 

Health Care Workers Who Work With 

Hazardous Drugs 

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: NIOSH intends to publish a 

Current Intelligence Bulletin (CIB) on 

alternative duty and other forms of 

administrative controls for health care 

workers who work with hazardous 

drugs and are trying to conceive, are 

pregnant, and/or are breast feeding. 

Alternative duty involves transferring 

the worker to a similar position, but one 

in which they would not be required to 

handle hazardous drugs. 

Exposure to certain hazardous drugs 

can affect reproduction and have 

adverse health effects on the developing 

fetus. Some hazardous drugs are known 

to be present in the breast milk of 

patients treated with them [Briggs et al. 

2005]. NIOSH plans to develop 

recommendations in this CIB on 

alternative duty and administrative 

controls that will protect the workers 

and their offspring from the potential 

adverse reproductive effects of 

hazardous drugs. 

NIOSH is requesting (1) comments 

and information relevant to the 

potential reproductive effects of 

hazardous drugs, (2) reports or other 

data that investigate possible adverse 

reproductive effects in workers exposed 

to hazardous drugs, and (3) information 

pertaining to alternative duty policies 

and administrative controls for workers, 

particularly couples trying to conceive 

and women who are pregnant and 

breastfeeding, and who are exposed to 

hazardous drugs in health care and 

other industries. 

Public Comment Period: Comments 

must be received within 60 calendar 

days of publication in the Federal 

Register. 

ADDRESSES: You may submit comments, 

identified by docket number NIOSH– 

150, 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, Room 111, 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: 

Thomas Connor, PhD, NIOSH Robert A. 

Taft Laboratories, MS–C23, 4676 

Columbia Parkway, Cincinnati, OH 

45226, (513) 533–8399, e-mail 

tmc6@cdc.gov. 

SUPPLEMENTARY INFORMATION: Drugs 

have a successful history in treating 

illnesses and injuries, and are 

responsible for many of our medical 

advances over the past century. 

However, virtually all drugs can have 

side effects associated with patient use 

[NIOSH 2004]. In addition to risks in 

patients, workers who handle them are 

at risk of suffering these effects. In 

addition, it is known that exposures to 

even very small concentrations of 

certain drugs may be hazardous for 

workers who handle them or work near 

them. Occupational exposures to 

hazardous drugs can lead to adverse 

reproductive events [NIOSH 2004, 

Dranitsaris et al. 2005]. 

The term ‘‘hazardous drugs’’ was first 

used by the American Society of 

Hospital Pharmacists (ASHP) in 1990 

and recent updates to their guidelines 

[ASHP 2006] and is currently used by 

NIOSH [2004] and the Occupational 

Safety and Health Administration 

(OSHA) [OSHA 1999]. Drugs are 

classified as hazardous if studies in 

animals or humans indicate that 

exposures to them have a potential for 

causing cancer, genotoxicity, 

developmental or reproductive toxicity, 

or harm to organs. Many drugs with a 

hazardous classification are used to treat 

illnesses such as cancer (antineoplastic 

drugs) or HIV infection (antiviral drugs). 

See Appendix A of the NIOSH Alert 

[NIOSH 2004] for examples of 

hazardous drugs and a full discussion of 

criteria used to define and classify them 

as hazardous. 

The numbers and types of work 

environments containing antineoplastic 

drugs are expanding as these agents are 

used increasingly for nonmalignant 

rheumatologic and immunologic 

diseases [NIOSH 2004]. 

When exposed to hazardous drugs, 

health care workers face several health 

risks, including reproductive risks. A 

reproductive hazard affects the 

reproductive function of women or men 

or the ability of couples to have healthy 

children [HSE 2003]. Some chemicals, 

including many hazardous drugs, are 

considered reproductive hazards 

because studies in humans or animals 

show that exposure to them may affect 

fertility, pregnancy outcome, or cause 

birth defects. 

Evidence shows that these drugs have 

caused adverse reproductive outcomes 

in health care workers. For example, 

nurses and pharmacists exposed to 

hazardous drugs at their worksite 

reported an increase in adverse 

reproductive events including 

spontaneous abortions, stillbirths, and 

congenital malformations when 

compared with unexposed health care 

workers [NIOSH 2004]. In addition, 

some drugs may negatively affect germ 

cell (sperm and egg) development 

[McInnes and Schilsky 1996]. 

In the United States, an estimated 8 

million health care workers [BLS 2007] 

are potentially exposed to hazardous 

drugs at their worksites and may be 

vulnerable to reproductive risks. These 

workers include pharmacists and 

pharmacy technicians, nursing 

personnel, physicians, operating room 


srobinson on DSKHWCL6B1PROD with NOTICES
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