REGULATORY AGENCIES

1. Federal Agencies

a.

Occupational Health and Safety Administration (OSHA)

The Occupational Safety and Health Act of 1970 created OSHA within the Department of Labor. All biomedical laboratories, and their employees, may be subject to the act. Although federal, state, and municipal laboratories were not specifically mentioned in the act, Executive Order 12196 (1980) made all federal agencies subject to the same requirements. The purpose of the act was to reduce occupational injuries and illnesses and each employer is required to furnish to each of his employees a job and a work environment that is free from recognized hazards that are causing, or are likely to cause, death or serious physical harm.

The relevant sections of the Health and Safety Standards (29 CFR Part 1910) are found within the General Industry Standards. Employers of 11 or more employees must maintain records of all injuries and illnesses as they occur. On-the-job accidents resulting in an employee's death or the hospitalization of five or more employees must be reported to the nearest OSHA office within 48 hours. Another relevant section is the Hazard Communication Standard (the "Right-to-Know" rule), which was revised recently to cover all employees exposed to hazardous chemicals, including those working in university research laboratories.

OSHA has documented its interest in the control of biological hazards by publishing an advanced notice of proposed rulemaking concerned with "Occupational Exposure to Hepatitis B Virus and Human Immunodeficiency Virus" (52 FR 45438, November 27, 1987).

Laboratories covered by the act are subject to inspection by OSHA compliance officers and health officers.

b.

National Institute for Occupational Safety and Health (NIOSH)

NIOSH was also created by the Occupational Safety and Health Act of 1970, but was made a component of the Centers for Disease Control within the Public Health Service of the Department of Health and Human Services. NIOSH does not regulate, issue, or enforce safety and health regulations. It has the responsibility to undertake research to eliminate on-the-job hazards to health and safety. When requested by employers or employees, health-hazard evaluations of workplaces are carried out.

c.

Environmental Protection Agency (EPA)

The Resource Conservation and Recovery Act of 1976, as amended, requires EPA to develop and evaluate environmentally sound methods for management of hazardous waste, including infectious waste. In May 1986, the EPA published its Guide for Infectious Waste Management (National Technical Information Service Publication No. PB86-199130, Springfield, VA 22161). This document is intended to provide guidance to persons responsible for infectious waste management at hospitals, medical laboratories, research laboratories, commercial diagnostic laboratories, animal experimentation units, industrial plants and laboratories, and other facilities that generate infectious waste, such as biotechnology companies. Its appendix contains a tabulation of the state regulations pertaining to infectious waste management, including a summary of the requirements and the identity of the responsible state agency.

d.

Food and Drug Administration (FDA)

The FDA issues regulations pertaining to the safety, efficacy, and labeling of drugs and medical devices, including diagnostic reagents and laboratory equipment, under the provisions of the Food, Drug, and Cosmetic Act, as amended, and of biological products under the provisions of the Public Health Service Act. The Office of Medical Devices in the Center for Devices and Radiological Health (CDRH) has the responsibility for laboratory instruments, diagnostic agents, and reagents. The Center for Drug Evaluation and Research (CDER) is responsible for the premarket testing and approval of drug products for human use, and the Center for Biologics Evaluation and Research (CBER) similarly controls biological products for human use, including blood and blood products, bacterial and virus vaccines, and certain diagnostic materials for dermal tests and laboratory tests. The regulations do not directly address issues of safety in biomedical laboratories. These matters are affected indirectly in the regulations covering Current Good Manufacturing Practices (21 CFR, Part 211) and Good Laboratory Practice for Non-clinical Laboratory Studies (21 CFR, Part 58), which apply to laboratories working with infectious materials in the course of research, development, testing, and manufacture of controlled products.

e.

National Institutes of Health (NIH)

The National Cancer Institute issues guidelines for the control of contamination in facilities working with cancer viruses. In conjunction with the Centers for Disease Control, the NIH published guidelines for Biosafety in Microbiological and Biomedical Laboratories, which has been reproduced as Appendix A in this publication. In addition the NIH publishes guidelines on various other aspects of laboratory safety, as well as on laboratory animal care. The NIH Guidelines for Research Involving Recombinant DNA Molecules were first published in 1976. They are updated periodically, most recently in 1986.

f.

Centers for Disease Control (CDC)

The CDC has the responsibility for controlling the interstate shipment of etiologic agents under the Public Health Service (PHS) Interstate Quarantine regulation (42 CFR, Section 72.25). The importation into the United States of etiologic agents and vectors of human disease, and subsequent transfer to other laboratories, requires the issuance of a permit to the recipient by the CDC under the provisions of the PHS Foreign Quarantine regulation (42 CFR, Part 71, Section 71.156). In addition to the CDC/NIH biosafety guidelines mentioned above, CDC publishes recommendations for various other aspects of laboratory safety and operations.

g.

U.S. Department of Transportation (DOT)

In addition to the CDC, the DOT has responsibility for regulating shipment of etiologic agents, diagnostic specimens, and biological products that are shipped in the United States. Its regulation differs in part from the CDC requirements in that packaging materials must have been proven to be adequate to contain infectious material under a variety of environmental and test conditions, and control is exerted over both intrastate and interstate shipments.

h.

U.S. Department of Agriculture (USDA)

The importation of etiologic agents of plant and animal diseases, serum specimens, and other materials of animal origin requires a permit that must be obtained from the appropriate authorities in the USDA. (See Chapter 3, Section G.)

i.

U.S. Postal Service (USPS) The USPS requirements for the mailing of "diseased tissues, blood, serum, and cultures of pathogenic microorganisms" are essentially the same as those of the CDC and DOT.

j.

U.S. Nuclear Regulatory Commission (U.S. NRC)

The U.S. NRC strictly regulates the possession, use, and disposal of radioactive materials under a licensing system.

k.

Health Care Financing Administration (HCFA)

By overseeing both Medicare and Medicaid programs and related medical care quality control, the HCFA has a direct relationship with hospital laboratory services and indirectly influences safety concerns. HCFA currently has the responsibility for licensing and inspecting clinical laboratories, which are subject to the Clinical Laboratory Improvement Act of 1967.

1.

Office of Science and Technology Policy (OSTP)

The Coordinated Framework for Regulation of Biotechnology: Announcement of Policy and Notice for Public Comment (1986) describes federal regulatory policy for ensuring the safety of biotechnology research and products. This document emphasizes mostly technologies for emerging genetic manipulation, such as recombinant DNA, and summarizes previously published policies of FDA, EPA, USDA, OSHA, and NIH.

2.

State and Local Government Regulations

States vary in their regulations applicable to biomedical laboratories and the handling of biohazardous waste. One summary of state laws regarding hazardous waste is found in the appendix of the Environmental Protection Agency (EPA) Guide for Infectious Waste Management (1986). This publication can be obtained from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325.