[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Notices]
[Pages 47594-47595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22275]


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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.

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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:
    <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#bad4d3d5c9d2ded5d9d1dfcefad9ded994ddd5cc"><span class="__cf_email__" data-cfemail="d5bbbcbaa6bdb1bab6beb0a195b6b1b6fbb2baa3">[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, 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 <a href="/cdn-cgi/l/email-protection#8cf8e1efbaccefe8efa2ebe3fa"><span class="__cf_email__" data-cfemail="d8acb5bbee98bbbcbbf6bfb7ae">[email protected]</span></a>.

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

[[Page 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 
Health-Syst Pharm 63:1172-1193.
    BLS [2007]. National Industry-Specific 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


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