Occupational Health and Safety Regulations and Recommendations Applicable to Nonhuman-Primate Research Facilities
Once a risk assessment has been completed, the final step before developing a risk management plan pertaining to OHS is understanding pertinent OHS standards. Leadership at institutions where nonhuman primates are used in research, teaching, or testing not only must be aware of workplace hazards and associated risks when developing their OHSP but also must be knowledgeable about and compliant with applicable regulations and guidelines. Those prerequisites can be a challenge in that multiple agencies or regulations may be applicable in a given institution. Regulation may be mandated at the federal and state levels and may depend on whether the nonhuman-primate work in question occurs in a federal facility or a federally funded institution. This chapter describes the important regulations and guidelines and provides contact information on organizations that can provide guidance and education on safety standards. Much of the information in this chapter can be found in Guide for the Care and Use of Laboratory Animals (NRC 1996) and Occupational Health and Safety in the Care and Use of Research Animals (NRC 1997) and is restated here for ease of use.
FEDERAL OCCUPATIONAL HEALTH AND SAFETY REQUIREMENTS
Occupational Safety and Health Act
The Occupational Safety and Health Act of 1970 mandates that all nongovernment employers provide a safe and healthful workplace for
their employees. It also provided for the creation of the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH). The act directs OSHA to develop and issue standards through a public rule-making process. Employers must comply with those OHS standards as they would with any statutory requirement (Blosser 1992).
The most important federal standards governing OHS are found in OSHA standard 29 CFR Part 1910 (www.osha.gov; Standards 29CFR). That document contains many sections that are pertinent to the work conducted in facilities where nonhuman primates are used in research, teaching, and testing. For example, the OSHA bloodborne pathogens standard (29 CFR 1910.1030) requires institutions to provide hepatitis B vaccinations to employees who handle blood, organs, or other tissues from experimental animals infected with hepatitis B virus and to make a confidential medical evaluation available to the employee immediately after an exposure to animal tissues that are contaminated with a bloodborne pathogen. The OSHA standard on occupational exposure to hazardous chemicals in laboratories (29 CFR 1910.1450) requires medical surveillance when monitoring reveals an exposure that routinely exceeds the action level for an OSHA-regulated substance, such as a time-weighted average of 0.75 ppm or a short-term exposure level of 2.0 ppm for formaldehyde (29 CFR 1910.1048). The OSHA standard regulating the use of compressed gases is 29 CFR 1910.101, personal protective equipment (PPE) standards are in 29 CFR 1910.132-1910.140, and electric systems requirements are in 29 CFR 1910. 301-1910.330 although other sections of 29 CFR 1910 might also be applicable.
It is important to note that the OSHA standards are not all-inclusive. They do not directly address every hazard or risk present at every worksite. To address hazards not covered by a particular standard, OSHA may cite Section 5(a)(1) of the Occupational Safety and Health Act (also designated 29 USC § 654(a)(1)); this provision is called the general duty clause because it imposes on employers the general obligation of furnishing workplaces that are “free from recognized hazards that are causing or are likely to cause death or serious physical harm” (Blosser 1992).
Occupational Safety and Health Administration
OSHA (www.osha.gov) is the federal agency charged with protecting the health of employees and preventing occupational injuries, disease, and death. Although OSHA and NIOSH were created by the same act of Congress, they are distinct agencies with separate responsibilities. OSHA is responsible for creating and enforcing workplace safety and health
regulations. It establishes protective occupational standards and enforces them through inspection and monetary penalties. It also provides free on-site support to identify and correct hazards and provides assistance in setting up OHS programs.
National Institute for Occupational Safety and Health (NIOSH)
NIOSH (www.cdc.gov/niosh/homepage.html) is the federal agency responsible for conducting research on and making recommendations for the prevention of work-related disease and injuries. NIOSH and OSHA often work together toward the goal of protecting worker safety and health.
NIOSH can be an excellent source of information on OHS for institutions and individuals. It publishes hazard-specific guidance (“hazard IDs”) such as Cercopithecine herpesvirus 1 (B Virus) Infection Resulting from Ocular Exposure, which is available online at www.cdc.gov/niosh/ and provides a summary of key points, a description of the hazard, recommendations for preventing B virus infections, recommended actions, and references for additional information.
Occupational Health and Safety in Federal Facilities
The Occupational Safety and Health Act in Section 19, also designated 29 USC 668, requires heads of federal agencies to establish and maintain comprehensive and effective OHS programs consistent with the standards set for nongovernment employers by OSHA (such as 29 CFR 1910), although no inspection oversight is detailed. Presidential Executive Order 12196, issued in 1980, further defines the responsibilities of federal agencies, including inspection requirements for federal OHS programs. The inspection requirements for federal agencies are listed in 29 CFR 1960; for example, inspectors must be safety or occupational health specialists or other persons with sufficient training or experience to recognize hazards and suggest general abatement procedures (29 CFR 1960.28(a)); and all agency workplaces must be inspected annually, and more frequent inspections must be conducted in workplaces where there is an increased risk of accident, injury, or illness (29 CFR 1960.25(c)). Furthermore, responsibility for oversight of federal OHS programs is assigned to the Office of Federal Agency Programs (OFAP), which functions as a “mini-OSHA” for federal employees. In essence, federal agencies must comply with the same OSHA standards as nongovernment employers; however, they are inspected by OFAP rather than OSHA, and they are not subject to monetary penalties.
Occupational Health and Safety Requirements for Federally Funded Institutions
The Public Health Service Policy on Humane Care and Use of Laboratory Animals (OLAW 2000) requires institutions that receive federal funds to have an OHS program as part of their overall animal care and use program. PHS Policy requires institutions to use the Guide for the Care and Use of Laboratory Animals (NRC 1996) as a basis of an institutional program for activities involving animals. The Guide includes OHS guidelines related to hazard identification and risk assessment; personnel training; personal hygiene; facilities, procedures, and monitoring; personal protection; and medical evaluation and preventive medicine for personnel. The Guide is discussed further later in this chapter.
The Office of Laboratory Animal Welfare (OLAW), in the Office of Extramural Research at the National Institutes of Health (www.grants.nih.gov/grants/olaw/olaw.htm), plays an important role in the implementation of PHS Policy. OLAW exercises compliance oversight of PHS Policy on research conducted or supported by any component of the PHS through approval of Animal Welfare Assurances. Each institution that receives federal funding must provide a written Assurance to OLAW. The Assurance Statement outlines how the institution will comply with PHS Policy, including how it will comply with the OHS guidelines outlined in the Guide. Once an Assurance Statement is accepted by OLAW, the institution is considered an “Assured” program. OLAW encourages programs to observe applicable industry standards, such as the National Research Council’s Occupational Health and Safety in the Care and Use of Research Animals (NRC 1997).
OLAW also requires the IACUCs of Assured programs to conduct semiannual program reviews and provides a suggested checklist to assist IACUCs in reviews. The OHS portion of the checklist, which is available online, is as follows (www.grants.nih.gov/grants/olaw/sampledoc/chek1a.htm):
Institutional program for a safe and healthy workplace
program is established and implemented
covers all personnel who work in laboratory animal facilities
based on hazard identification and risk assessment
personnel training (e.g., zoonoses, hazards, pregnancy/illness/ immunosuppression precautions)
personal hygiene procedures (e.g., work clothing, eating/ drinking/smoking policies)
procedures for use, storage & disposal of hazardous biologic, chemical, and physical agents
specific procedures for personnel protection (e.g., shower/change facilities, injury prevention
Program for medical evaluation and preventive medicine for personnel
pre-placement evaluation including health history
immunizations (e.g,. rabies and tetanus) and tests as appropriate
zoonosis surveillance as appropriate (e.g., Q-fever, tularemia, Hantavirus, plague)
procedures for reporting and treating injuries, including bites, etc.
Special precautions for personnel who work with primates
tuberculosis screening includes all exposed personnel
training and implementation of procedures for bites & scratches
education regarding Cercopithecine herpesvirus 1 (B virus)
AAALAC International in its review of accredited institutions found the most common deficiencies in the OHSP were: 1) they were not based on hazard identification/risk assessment, and 2) there was inadequate personal protection and hygiene. Less common deficiencies were found in: 1) personnel training, 2) facilities, procedures, and monitoring, and 3) medical evaluation/preventive medicine (DeLong and others 2001). Aspects of the OHSP that are considered by AAALAC International in assessments of animal care and use programs can be found in the Program Description at HtmlResAnchor www.aaalac.org/download.htm.
Federal Nonhuman-Primate Import and Quarantine Requirements and Worker Protection Recommendations
The provisions of 42 CFR 71 seek to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the states or possessions of the United States. Section 42 CFR 71.53 specifically addresses the importation of live nonhuman primates and restricts that activity to registered importers. Live nonhuman primates may be imported into the United States and sold, resold, or otherwise distributed only for bona fide scientific, educational, or exhibition purposes.
The Division of Global Migration and Quarantine in the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (www.cdc.gov/ncidod/dq/) is responsible for preventing the importation and spread of zoonotic illness capable of causing serious outbreaks of communicable disease in humans (such as Marburg/Ebola, monkeypox, yellow fever, and tuberculosis). Its emphasis is on minimizing exposure to imported nonhuman primates during transit and during the mandatory 31-day quarantine period and vigilant surveillance for zoonotic illness.
Nonhuman-primate importers must register with the CDC and certify that the nonhuman primates imported will be used for science, education, or exhibition as defined in the regulations. They must also implement disease-control measures and isolate the nonhuman primates for 31 days. The importers must report suspected zoonotic illness in the nonhuman primates or in workers and maintain records regarding nonhuman-primate distribution. As of this writing, the CDC program has 28 registered nonhuman-primate importers.
CDC’s import-quarantine program activities include development of recommendations for disease-control measures, inspection of quarantine facilities, monitoring of arriving shipments, assessment of disease-control measures, review of animal health records, and investigation of illness reports. Worker-protection measures advocated by CDC for activities in the importation and quarantine of nonhuman primates include:
Limiting access to imported animals and tissues during transit and quarantine
Implementation of an employee OHS program:
Zoonotic-disease risk and prevention training
Respiratory protection program:
Use of appropriate PPE
Worker illness and injury surveillance
Additional requirements and recommendations for registered nonhuman-primate import and quarantine activities pertain to facility design and operation, incorporation of disease-control measures into all standard operating procedures that present risk, engineering controls, waste-handling precautions, and PPE recommendations for all activities during quarantine beginning with the animals’ entrance onto an aircraft.
Requirements Related to Import and Export of Nonhuman-Primate Material
National Center for Import and Export
The National Center For Import and Export (NCIE) of the US Department of Agriculture Animal and Plant Health Inspection Service (APHIS) has regulatory authority over the importation of human or nonhuman-
primate material that is produced in tissue culture or is a potential or actual zoonotic pathogen. For more information regarding import and export requirements of APHIS, see www.aphis.usda.gov.
US Public Health Service
The US Public Health Service (USPHS) has jurisdiction over all human and nonhuman-primate materials (USPHS 42 CFR - Part 71 Foreign Quarantine. Part 71.54 Etiologic agents, hosts, and vectors). Packages containing etiologic agents or vectors originating in foreign locations must have an importation permit issued by the United States Public Health Service. USPHS can be contacted at: Department of Health and Human Services, Centers for Disease Control, Office of Biosafety, Atlanta, GA 30333, or by telephone at 404-639-3883.
US Department of Transportation
The Department of Transportation (DOT) has regulations regarding the transportation of hazardous materials, which include infected live animals or tissues. DOT can be reached at www.dot.gov; questions can be sent via e-mail to DOT information specialists at firstname.lastname@example.org.
STATE OCCUPATIONAL HEALTH AND SAFETY REQUIREMENTS
The Occupational Safety and Health Act allows states to establish their own programs for issuing and enforcing OHS standards. These state programs are subject to certification by OSHA. States may also, subject to OSHA approval, assert jurisdiction over health and safety issues for which OSHA has no federal standard. State standards must be at least as stringent as the OSHA standards. When OSHA adopts a new standard, the state programs must issue corresponding rules. As of this writing, the following states (and Puerto Rico and the Virgin Islands) have chosen to administer their own OSHA-approved programs:
Guide for the Care and Use of Laboratory Animals
As described above, the Guide for the Care and Use of Laboratory Animals (NRC 1996) is prescribed by the PHS policy as the basis for institutional animal care and use programs, including OHS programs. Chapter 1 of the Guide, “Institutional Policies and Responsibilities,” provides substantive guidance on OHS. The Guide emphasizes that an effective program must rely on strong administrative support and interactions among several institutional programs, including the research program (as represented by the investigator), the animal care and use program (as represented by the veterinarian and the IACUC), the environmental health and safety program, occupational health services, and administration (for example, human resources, finance, and facility maintenance). Day-to-day safety in the workplace is the responsibility of the laboratory or facility supervisor (such as, principal investigator, facility director, or laboratory animal veterinarian) and depends on maintenance of safe equipment and facilities as well as performance of safe work practices by all employees. The Guide also provides guidance on hazard identification and risk assessment; personnel training; personal hygiene; facilities, procedures, and monitoring; animal experimentation involving hazards; personal protection; and medical evaluation and preventive medicine for personnel.1
Occupational Health and Safety in the Care and Use of Research Animals
Occupational Health and Safety in the Care and Use of Research Animals (NRC 1997) provides guidelines for the occupational health and safety of institutional employees, visitors, and students who might be exposed to hazards in the course of their work with research animals. The Office for Laboratory Animal Welfare strongly encourages institutions to observe the standards set out in this report, which is also available online.2 The general concepts set forth apply to many categories of institutions: academic, industrial, and government research institutions; biomedical and agricultural research institutions; and medical and veterinary educational institutions. The report provides the following specific recommendations:
We recommend that every institution initiate a concerted effort to address the health and safety hazards and the risks of occupational illness and injury that are associated with the care and use of research animals and broaden its occupational health and safety program as necessary to reduce the risks to an acceptable level.
We recommend that the senior official of an institution demonstrate personal commitment to a safe and healthful workplace, delegate clearly defined duties to those with authority to commit and direct institutional resources, and establish mechanisms for monitoring the success of the occupational health and safety program.
We recommend that every institution develop a multidisciplinary approach to occupational health and safety that permits the continuing evaluation of potential workplace hazards and of the risks to employees working with animals.
We recommend that the determination of need for health-care services be based on the nature of the hazards associated with the care and use of research animals and the intensity and frequency of employee exposure to these hazards.
We do not recommend serum collection and storage as standard components of an occupational health and safety program. They have value only for employees who have substantial likelihood of occupationally acquired infection with an agent that can be monitored serologically.
We do not recommend a physical examination as the principal surveillance tool for periodic health evaluations. We recommend that a careful history based on a knowledge of workplace risks be used for this purpose.
Biosafety in Microbiological and Biomedical Laboratories
Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH 1999) is a major resource for guidelines on safe handling of infected animals as well as for nonhuman-primate cells and tissues. It includes detailed descriptions of criteria for animal biosafety, infectious agents and biosafety cabinets. This document can be accessed online or ordered from the Government Printing Office.3
Online address: www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm; Government Printing Office address: Superintendent of Documents, U.S. GPO, Washington, DC 20402 or online at https://orders.access.gpo.gov/su_docs/sale/prf/prf.html.
Association for Assessment and Accreditation of Laboratory Animal Care International
The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) is a private, nonprofit organization that promotes the humane treatment of research animals through a voluntary accreditation program. This confidential peer review assesses the quality of all aspects of an animal care and use program, including animal husbandry, veterinary care, institutional policies, and the facilities where animals are housed and used. More specifically, AAALAC International carefully reviews OHS programs and assesses their design, scope, and effectiveness in light of the nature of the animal research being conducted. AAALAC International’s standards are based on each country’s regulations, the principles outlined in the Guide for the Care and Use of Laboratory Animals (NRC 1996), and other broadly accepted reference resources. AAALAC International can be reached online at www.aaalac.org or by sending an e-mail to email@example.com.
American National Standards Institute
The American National Standards Institute (ANSI) is a private, nonprofit organization that administers and coordinates the US voluntary standardization and conformity assessment systems. The Institute’s mission is “to enhance both global competitiveness of US business and the US quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity.”
Of particular interest to managers of facilities that use nonhuman primates in research, teaching, and education are ANSI standards Z358.1-1998, “Emergency Eyewash and Shower Equipment,” and Z87.1-1989 (R1998), “Occupational and Educational Eye and Face Protection.” ANSI can be reached on line at HtmlResAnchor www.ansi.org.
ASTM International (formerly the American Society for Testing and Materials) was organized in 1898 and is one of the largest voluntary standards development organizations in the world. The organization’s mission is “to be the foremost developer and provider of voluntary consensus standards, related technical information, and services having internationally recognized quality and applicability that promote public health and safety, and the overall quality of life; contribute to the reliability of materials, products, systems, and services; and facilitate national,
regional, and international commerce.” Familiarity with ASTM International fluid resistance and permeability standards is beneficial when one is researching and selecting personal protective clothing. ASTM can be reached on line at HtmlResAnchor www.astm.org/.
American Conference of Governmental Industrial Hygienists
The American Conference of Governmental Industrial Hygienists (ACGIH®) is a member-based organization that “advances worker health and safety through education and the development and dissemination of scientific and technical knowledge.” ACGIH® is one of the industry’s leading publication resources, with over 400 titles related to occupational and environmental health and safety, including the Threshold Limit Values (TLVs®) and Biological Exposure Indices (BEIs®). ACGIH® can be reached on line at www.acgih.org.
International Air Transport Association
International Air Transport Association (IATA) partners are airline suppliers and service providers who participate through partnership programs that provide a forum through which these companies develop industry solutions. The IATA Live Animals Regulations are the recognized worldwide standards for transporting live animals by commercial airlines. Countries, such as the member states of the European Union, enforce the IATA regulations for the transportation of live animals. Government agencies, such as the U.S. Fish and Wildlife Service, and the management authorities of the Convention on International Trade in Endangered Species also enforce the regulations for the packaging of endangered species for international transport. It is essential that shipping, acceptance, and handling staff as well as all others involved in the transportation of live animals be familiar with IATA. IATA can be reached on line at www.iata.org/cargo/index.htm.