National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Request for information and comment.
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft Current Intelligence Bulletin entitled NIOSH Current Intelligence Bulletin: Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare Workers and Recommendations for Reducing Exposures now available for public comment. To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2015-0003 in the search field and click “Search.”
Public comment period: Electronic or written comments must be received March 24, 2015.
You may submit comments, identified by CDC-2015-0003 and Docket Number NIOSH-279, by either of the following two methods:
Federal eRulemaking Portal: http://www.regulations.gov Follow the instructions for submitting comments.
Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, Ohio 45226-1998.
Instructions: All information received in response to this notice must include the agency name and docket number [CDC-2015-0003; NIOSH-279]. All relevant comments received will be posted without change http://www.regulations.gov, including any personal information provided. All information received in response to this notice will also be available for public examination and copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226.
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Background: The NIOSH Current Intelligence Bulletin: Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare Workers and Recommendations for Reducing Exposures reviews and summarizes all published studies on adverse reproductive effects of occupational exposures to antineoplastic drugs. Hazardous drugs, especially antineoplastic drugs, are some of the most potent teratogenic chemicals known. In addition, they can affect germinal cells, reproduction, and exposures can result in spontaneous abortion. This document summarizes results of animal studies, occupational epidemiology studies, as well as adverse effects that have been observed in patients treated with these drugs. While workplaces should be safe for all employees, the unique sensitivity of the developing fetus and the infant who is Start Printed Page 3602breastfeeding necessitate the need for extra precautions when these drugs are handled by both males and females who are trying to conceive, women who may become or who are pregnant, and women who are breast feeding. Recommendations for temporary reassignment of duties or alternative duty are included in this guidance document.
Information Needs: Additional data and information are needed to assist NIOSH to protect the reproductive health of healthcare workers who come in contact with antineoplastic drugs. Information is needed for: (1) Appropriateness of guidance, (2) Effect on work practices, (3) Confidentiality issues, (4) Financial impact.
NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate:
- Relevant publications not included in this document
- Institutional and organizational policies in effect
- Other relevant information related to this topic
Connor TH, DeBord G, Pretty JR, Oliver MS, Roth TS, Lees PSJ, Krieg EF, Rogers B, Escalante CP, Toennis CA, Clark JC, Johnson B, McDiarmid MA . Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J Occup Environ Med 52: 1019-1027.
Connor TH, Lawson CC, Polovich M, McDiarmid MA . Reproductive health risks associated with occupational exposures to antineoplastic drugs in health care settings. JOEM 56: 901-10.
Lawson CC, Rocheleau CM, Whelan EA, Lividoti Hibert EN, Grajewski B, Spiegelman D, Rich-Edwards JW . Occupational exposures among nurses and risk of spontaneous abortions. Am J Obstet Gynecol 206 (327):e1-8.
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FOR FURTHER INFORMATION CONTACT:
Thomas H. Connor, NIOSH, Division of Applied Research and Technologies, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C23, Cincinnati, Ohio 45226, Phone: (513) 533-8399, Email: firstname.lastname@example.org.
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Dated: January 15, 2015.
Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
[FR Doc. 2015-01209 Filed 1-22-15; 8:45 am]
BILLING CODE 4163-18-P