Minimal Clothing Attire and Required Personal Protective Equipment for Work in NIH Laboratories

Supervisors and employees are responsible for assuring that the minimal clothing attire and minimal PPE requirements are adhered to when working in NIH laboratories.  This policy applies not only to persons performing laboratory operations, but also to persons who may be in the laboratory only temporarily.

When present in laboratories, employees must wear appropriate clothing that minimizes direct contact of materials with their skin. Examples of appropriate clothing that fulfil this requirement include long pants or leg covering and closed toe shoes.

In addition to the minimum clothing requirement, appropriate PPE that serve as primary barriers to exposures is required. PPE requirements include:

• A lab coat or equivalent body covering to be worn while performing any laboratory operations or in areas adjacent to work with hazardous materials. Hazardous materials include substances harmful to health or reagents that pose physical hazards.

• Eye protection is mandatory where there is potential for injury. Eye protection (e.g. protective glasses, goggles, face shield) must be appropriate for the type of hazard (e.g. chemical splash and vapors, lasers, ultra violet light).

• Gloves are required when performing laboratory operations. The type of glove must be appropriate for the material being handled.

Additional or specialized PPE may be required depending on the properties of the hazardous materials being worked with or present in the laboratory or as result of risk assessment.  For guidance and assistance with assessing risk of hazardous materials, choosing appropriate PPE beyond that which is minimally required, or precautions such as engineering controls, contact the Division of Occupational Health and Safety (301 496-2960).

Charter for the NIH Occupational Safety and Health Committee

The NIH Occupational Safety and Health Committee (OSHC) provides safety policy recommendations to the Director of the NIH, or his/her designee, in matters pertaining to occupational health, accident control and fire prevention.

Duties of the Committee

1. Meets quarterly, or more often as required, to identify substantive biomedical research areas and institutional support programs where occupational health, safety and fire hazards may exist.
2. Recommends policies regarding occupational health, accident control, and fire prevention.
3. Provides technical advice, assistance and management-level support to the Directors of the Division of Occupational Health and Safety (DOHS), Division of Radiation Safety (DRS) and the Division of Fire the Marshal (DFM) in matters regarding occupational health, accident control and fire prevention.
4. Encourages the development of and supports the activities of IC Safety and Health Committees and maintains liaison with these committees.
5. Monitors and reviews inspection reports, safety and health training programs; plans for abating hazards, medical surveillance initiatives, reports of occupationally acquired illnesses and injuries, responses to reports of hazardous conditions, safety and health program deficiencies and complaints regarding safety and health programs.
6. Provides to the Director, NIH, or his/her designee a summary report reviewing the results of the annual workplace inspections of all NIH facilities.
7. Conducts annual reviews of the NIH Chemical Hygiene Plan and performs Committee responsibilities as specified in the Plan.
8. Establishes working groups and appoints ad hoc members to the Committee, as necessary, to effectively carry out its duties.

Membership and Organization of the Committee

The Committee is composed of 10 or more voting members appointed by the Director of the NIH or his/her designee.

All members should be recognized as persons of good judgment and should represent the diversity of occupational areas and accident experience of the NIH. The disciplines of chemistry, toxicology and medicine must be represented on the Committee. At least 5 members are selected from among the current chairpersons of established IC Safety and Health Committees. One member should be an Intramural Principal Administrative Officer, to provide an administrative perspective and approach. One member is the American Federation of Governmental Employees (AFGE) Health and Safety Officer from the NIH Local. The Director, DOHS or his/her designee, serves as Executive Secretary. The Director, Division of Environmental Protection, Director DFM, Medical Director, Occupational Medical Service, DOHS, and a representative appointed by the Director, Office of Research Facilities Development and Operations, serve as permanent, non-voting, resource members of the Committee. The Director of the NIH or his/her designee selects the Chairperson from among the Committee membership. The Chairperson serves a two-year term. The members serve overlapping terms of three years duration. The Chairperson and members may be reappointed for additional terms.

Charter for the IC Safety and Health Committees

The IC Safety and Health Committee serves as a conduit for communication between the IC employees, management, the Division of Occupational Health and Safety (DOHS) and the Division of Radiation Safety (DRS) concerning occupational safety and health matters. The objective of the IC Safety and Health Committee is to support the development, implementation, maintenance and improvement of a comprehensive Occupational Safety and Health Program that reflects NIH policy to:

• provide the highest practical degree of occupational safety and health for employees in all activities of the NIH;

• minimize losses in human resources and property damage due to accident, injury or work-related illness; and

• comply with Public Law 91-596 (The Occupational Safety and Health Act of 1970), Executive Order 12196, and other regulations, standards and guidelines governing the occupational safety and health of HHS employees.

Each IC is required to establish an IC Safety and Health Committee.

Duties of the Committees:

 The IC Safety and Health Committee will report to the IC Director through the Scientific Director. In those ICs that do not have a Scientific Director, a senior administrator, appointed by the IC Director, will serve to facilitate safety related communication between the Committee and the IC Director. The IC Safety and Health Committee in an effort to monitor and assist in the execution of the NIH's safety and health policies and programs shall:

1. Meet at least on a quarterly basis and report through the Scientific Director to the IC Director.
2. Keep minutes of all IC Safety and Health Committee meetings, distribute the minutes to all members and the IC Scientific Director, and make copies available upon request, to IC employees.
3. Monitor performance of safety and health activities of the IC and make recommendations to the IC Scientific Director on the effectiveness of these activities.
4. Develop policies and programs in coordination with the DOHS and the DRS specific to the IC in regard to occupational safety and health matters.
5. Perform annual workplace surveys with the assistance of the DOHS to assure compliance with NIH and OSHA safety and health policies and standards. These surveys will be conducted using standardized criteria developed by the DOHS. A corrective action plan will be prepared and implemented, addressing any deficiencies found during the survey. The IC will disseminate the results of these surveys and corrective actions to the IC Scientific Director, NIH Occupational Safety and Health Committee (OSHC) and the Director of the Office of Intramural Research, as appropriate.
6. Develop procedures for handling occupational safety and health suggestions, recommendations and reports of hazardous conditions from IC employees.
7. Review and comment on proposed NIH policies, guidelines and standards concerning occupational safety and health as requested by the OSHC.
8. Assist in the development of prevention strategies for work related accidents resulting in personal injury, illness and/or property damage.
9. Assist the Office of Intramural Research, the DOHS and the DRS in the dissemination of safety information in the event of an emergency or on an as-needed basis.
10. Conducts quality assurance checks of biological sample inventories associated with non-registered laboratories. Reports discrepancies to the IC Scientific Director and DOHS.

Membership and Organization of the Committee:

The Committee is composed of IC employees selected by the IC Scientific Director or his/her designee, who represent the diverse occupational areas of the organization. Membership shall include (where applicable), but not be limited to the following individuals.

• Senior research personnel

• Principal Administrative Officer

• Facilities management staff

• A representative from each IC operating component (branch, laboratory, etc.)

• Occupational Safety and Health Specialist

• Health Physicist

The IC Scientific Director or his/her designee shall select the chairperson from among the Committee membership. The chairperson serves a two-year term.
The members serve overlapping terms of three years duration. The chairperson and members may be reappointed to serve additional terms.

Charter for the NIH Institutional Biosafety Committee

The NIH Institutional Biosafety Committee (IBC) provides recommendations for safety policy to the Director, NIH, or designee, and Deputy Director for Intramural Research (DDIR) in matters pertaining to the control of hazards associated with the intramural use of microbiological agents, their vectors and associated recombinant and synthetic molecular technologies. The IBC serves as an advisory body to the Division of Occupational Health and Safety (DOHS), Office of Research Services (ORS). Committee functions include those designated for the Institutional Biosafety Committee in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines).

Duties of the Committee

1. Recommends policies regarding biosafety to the Deputy Director Intramural Research and the Director, NIH.

2. Provides technical advice, assistance, and management-level support to the DOHS, ORS, and to the NIH Biosafety Officer in matters regarding biosafety.

3. Identifies substantive biomedical research areas where biohazards may exist.

4. Performs the functions of an Institutional Biosafety Committee as specified in the NIH Guidelines including the formal review of all infectious disease research performed at BSL-2 and above.

5. Recommends procedures for approving operations involving microbiological agents and their vectors that require maximum containment considerations for biosafety and for agents that, in the judgment of the Committee, may constitute unique or serious hazards.

6. Through the research review and registration process, addresses concerns regarding the Dual Use nature of proposed research by reviewing information submitted by Principal Investigators (PIs) in a Dual Use Questionnaire review process. PIs must address these concerns annually to assess if new research findings impact potential dual-use concerns regarding their work. The NIH IBC will regularly review risk mitigation plans associated with research proposals.

7. Reviews accidents resulting in personnel exposures to hazardous microorganisms or widespread area contamination and reports of non-compliance with established national and NIH policies regarding the safe conduct of research involving hazardous microorganisms.

8. Establishes working groups and appoints ad hoc members to the Committee, as the Committee deems it necessary, to effectively carry out its duties.

9. Annually reviews the NIH Exposure Control Plan for Non-Hospital Personnel Can initiate reviews of emerging biosafety issues of particular interest or concern to the NIH and the surrounding community.

Membership and Organization of the Committee

The Committee is composed of a minimum of ten members appointed by the Director, NIH, or designee. Six members are nominated from among the intramural research community; five are scientists representing a diversity of disciplines relevant to biomedical research, infectious diseases, and recombinant DNA technology including at least one animal research expert and one human gene therapy expert. One scientist is a non-doctoral employee from a biomedical research laboratory. Intramural research community members must be senior, tenured researchers within their respective Institutes.  The NIH Biosafety Officer is a member and serves as the Executive Secretary. A minimum of two members are also selected from the general public who are not affiliated with the NIH apart from their membership on the Committee. One member who is nominated by the Director, Office of Research Facilities Development and Operations, shall have expertise pertaining to design, operational capability, and maintenance of NIH research facilities. The Director, NIH, or designee selects the chairperson from among the Committee membership. The chairperson serves a two year term. The members serve overlapping terms of three years duration. The chairperson and members may be reappointed for 
additional terms.

Charter for the NIH Radiation Safety Committee 

1. Mission Statement
   
   The Radiation Safety Committee (RSC) is responsible to the Director, NIH for oversight of the NIH Radiation Safety Program to ensure the safe use of radioactive materials and all sources of ionizing radiation throughout NIH and those NIH-occupied buildings included in the NIH Radiation Safety Program. The RSC is responsible for formulating policy with regard to radiation protection matters in the intramural research program that involve NIH employees and members of the general public, routine clinical and clinical research programs, and protection of the environment to ensure compliance with Federal regulations, including those of the U.S. Nuclear Regulatory Commission. The Radioactive Drug Research Committee is a subcommittee of the NIH Radiation Safety Committee. The Radiation Safety Officer (RSO) is responsible to the Director, NIH, for management and operation of the Radiation Safety Program as well as policy directives of the RSC. The RSO and RSC shall be provided sufficient authority, organizational freedom, and management prerogative to accomplish these goals. These responsibilities and authorities are limited to the NIH's intramural research program and client agencies served under USNRC license 19-00296-10.

2. Duties of the Committee

   1. Ensures the safe use of all radioactive materials and sources of radiation throughout NIH and those NIH-occupied buildings included within the NIH Radiation Safety Program, for the Director, NIH.

   2. Delegates to the NIH Radiation Safety Officer the authority to implement the Radiation Safety Program and enforce applicable Federal regulations and NIH radiation safety policies and procedures to ensure the radiation safety of persons and protection of the environment.

   3. Provides technical advice, assistance, and management-level support to the Radiation Safety Officer in implementing the Radiation Safety Program and the NIH program for maintaining radiation exposures to employees, patients, and research subjects as low as reasonably achievable (ALARA).

   4. Reviews the Radiation Safety Program at least annually to determine that all activities involving radioactive materials and sources of radiation are being conducted safely and in accordance with applicable Federal regulations and NIH radiation safety policies.

   5. Reviews the qualifications of licensed physicians and grants approval for the use of radioactive materials in human subjects.  If a Committee member is an investigator who may participate in the research being proposed in an application to the Committee, he or she shall abstain from voting on the approval or disapproval of the application.

   6. Performs functions of the Radioactive Drug Research Committee in accordance with applicable regulations of the Food and Drug Administration, HHS.

   7. Approval of the RSC is required before the initiation of approved clinical research studies involving exposure of human subjects to ionizing radiation for research purposes from which the subject does not benefit, i.e., when normal volunteers or patient volunteers are involved and the use of radiation or radioactive materials is not a standard medical procedure which is required for the clinical management of the patient. Research uses subject to this review shall include all studies involving normal volunteers and experimental procedures for diagnosis or treatment, including uses for which an Investigational New Drug (IND) application is required by the FDA and radioactive research drugs regulated under FDA regulations contained in 10 CFR 361, §361.1.

   8. The Chairperson of the Radiation Safety Committee acts for the Director, NIH, in all matters relating to Federal or state radioactive material or radiation source licensing.

   9. Establishes and revises radiation safety policies, consulting with the Office of the Director through the Management Representative on issues that require involvement of upper level management, e.g., in cases when there is significant potential for impact on the NIH mission.

   10. Establishes working groups and appoints ad hoc members to the Committee, as the Committee deems necessary.

3. Membership and Organization of the Committee 
   
   The membership of the Committee shall include the following: The Radiation Safety Officer; a representative of the Office of the Director of the NIH who is not an Authorized User (this person serves as the "Management Representative"); a physician who is authorized by the RSC for clinical use of radioactive materials; a person who is authorized by the RSC for the use of radioactive materials in laboratory research, and a representative of the nursing service. Members are appointed by the Director of the NIH or his/her designee. The Medical Board may be consulted to identify nominees for membership on the RSC to represent clinical care areas; the Board of Scientific Directors may be consulted to identify nominees for other positions. Membership shall include representation of the various types of users of radioactive materials and radiation sources at NIH. Additional members may be added to the RSC, upon recommendation of its Chair to enable effective action by the Committee. The following are highly recommended: The Chair of the RDRC; a health or medical physicist with training and experience in radiation dosimetry of radioactive materials administered to humans, a radiopharmacist; physicians with expertise in diagnostic radiology, nuclear medicine, and radiation therapy; individuals with these qualifications in the list of mandatory members may serve the RSC in these areas of expertise. Members shall serve three-year terms, with staggered terms to provide for continuity. With the member’s consent, the Chairperson may renew a member’s appointment. The Chairperson’s appointment shall be effective until the Chairperson resigns or until another Chairperson is appointed by the Director, NIH. When members are replaced, new appointees shall be chosen to maintain the balance of members required under 10 CFR 35.
   
   The Division of Radiation Safety shall provide administrative support to the Committee and shall maintain the official Committee files.
   
   Meetings shall be conducted at a frequency sufficient to meet the requirements of 10 CFR 35. A majority of Committee members shall constitute a quorum for the conduct of official Committee business.