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Transmittal Notice

  1. Explanation of Material Transmitted: This manual chapter updates the National Institutes of Health (NIH) policy on admittance of minors to hazardous work areas that may contain inherently or potentially hazardous chemicals, radiological hazards, biohazards, or hazardous equipment. Revisions include clarification of safety language, particularly regarding minors working with or near radiological hazards; and links have been updated to reflect current web addresses and policies. This revision also adopt the recently updated Manual Chapter System in accordance with MC-1710 Publishing and  Maintaining Policies in the NIH Policy Manual.
  2. Filing Instructions:

Remove: NIH Policy Manual, Chapter 3015, dated 06/01/2010

Insert: NIH Policy Manual, Chapter 3015, dated 07/26/2017

PLEASE NOTE: For information on:

 

 

 

This chapter updates NIH policy on the admittance of minors to areas that may contain inherently or potentially hazardous chemicals, radiological hazards, biohazards, or hazardous equipment.

B. Background and Scope

Research laboratories and the facilities that support them contain numerous hazards. Of particular note at NIH are biological hazards from pathogens, animal allergens, hazardous chemicals, and mechanical hazards associated with laboratory equipment and facility support equipment (e.g., HVAC equipment, etc.). Specialized training and experience is necessary to safely work in these areas and avoid potential injury or illness. As such, minors should only be permitted in laboratories and laboratory support areas under limited and closely monitored circumstances.

It is the policy of the NIH to allow minors, whether they are NIH employees or visitors, to access non-hazardous areas of the NIH without special approvals.  However, the following policies apply to minors when accessing areas deemed as hazardous at the NIH and require special written approval.

General procedures for obtaining written approval for minors entering areas that have been deemed as hazardous can be found in Section E of this document.

  1. Minors who are Patients / Healthy Research Volunteers – are not exempt from this policy but may have additional restrictions as defined in the Clinical Center (CC) Medical Administrative Policy M92-10, Children in the Clinical Center available at  http://cc-internal.cc.nih.gov/policies/PDF/M92-10.pdf
  2. Minors who are Employees – Minors who are working as student volunteers, special volunteers, or as summer students are considered “employees” for the purpose of this policy.
    1. All minors who are employees working at the NIH must be at least 16 years of age and be appointed as prescribed in NIH Manual 2300-308-1, “Guest Researcher/Special Volunteer Programs”.
    2. Minors that are employees may not work with human and/or nonhuman primate blood, body fluids and tissues.
    3. Requirements for Minors Intending to Use Radiation - Prior to working with radiation (i.e., radioactive materials, radiation producing devices, or sealed source irradiators),   a minor must submit an NIH application for use of Radiation by a Minor to the NIH Radiation Safety Officer (RSO), Division of Radiation Safety (DRS), Office of Scientific Resources (SR), Office of Research Services (ORS), for approval. The DRS will verify the following criteria are met:
      1. Minors under age 16 are prohibited from working with radiation;
      2. Minors 16 or 17 years of age are prohibited from handling source vials and need special permission from the RSO to use other radioactive materials, including performing monthly surveys;
      3. Before working with radioactive materials, minors must have successfully completed the NIH "Laboratory Safety", "Radiation Safety in the Laboratory" and Hands-on practical courses;
      4. If working with radiation producing devices, minors must complete the “Laboratory Safety” and appropriate “Radiation Safety for X-ray Users” courses;
      5. Minors planning to use sealed source irradiators must complete the “Laboratory Safety” and “Radiation Safety for Irradiator Users” courses, and are ineligible for unescorted access to irradiators;
      6. All minors planning to use radiation at the NIH must complete a dosimetry evaluation form;
      7. Written consent of the minor’s parent(s) or legal guardian(s) is required as part of the approval process;
      8. All use of radiation by an RSO-approved minor must be directly supervised by a trained adult NIH staff member at all times;
      9. Failure to supervise a minor while he or she is using radiation will result in immediate suspension of the Authorized User's privilege to order and receive radioactive materials and notification of the IC and OD office management for the staff member responsible for the supervision.
      10. Minors cannot use radiation until their Authorized User or direct Supervisor receives an approved application form signed by the NIH RSO..
    4. Hazardous Laboratories or Animal Areas – Minors who are employees are not permitted in the following areas:
      1. Laboratories posted at Biosafety Level 3 or Biosafety Level 4;
      2. Laboratories posted at Biosafety Level 2 with Biosafety Level 3 Practices;
      3. Laboratories in which known carcinogens, reproductive toxins or other acutely toxic chemicals are being handled;
      4. Areas of high radiation or airborne radioactivity (as defined in 10 CFR 20.1003);
      5. Areas with active Class 3B or 4 lasers;
      6. Nonhuman primate holding rooms; and,
      7. Areas where procedures with awake nonhuman primates are conducted.
  3. Minors who are Visitors
    1. Laboratories - Visiting minors will not be permitted in any laboratory except with the specific written permission of the laboratory director. A laboratory director contemplating a visit by his/her own minor children will obtain written authorization from his/her supervisor.
    2. Clinical Center - - Non-patient minors shall be under adult supervision at all times during their visit. Minors may visit patients in most patient rooms. However, minors under 12 years of age are not permitted into any Clinical Center laboratory, patient care area, or administrative area of the hospital or clinic (including, but not limited to, treatment rooms, physician’s offices, patient isolation rooms, operating or recovery rooms, ICU’s, or other “restricted” areas) unless specific permission is obtained beforehand from the attending physician, head nurse, or other appropriate supervisor.
    3. Hazardous Building, Trade, Craft Areas or Construction Site - Specific written permission by the appropriate supervisor is required before visiting minors are permitted into any shop, mechanical space, or construction site. All minors must be continually supervised while in such areas. Furthermore, minors are not permitted into areas posted with restrictive warning signs. Examples are: “Danger – Asbestos”, “High Voltage”, “Caution – PCB’s”, “Danger – High Noise Hazard”, “Authorized Personnel Only.”
    4. Hazardous Laboratories or Animal Areas - Visiting minors are not permitted in areas posted with radiation warning signs or into any animal facility, except with the specific written permission of the laboratory or animal facility director. Visiting minors and employees under 18 years of age are not permitted in the following areas:
      1. Laboratories posted at Biosafety Level 3 or Biosafety Level 4;
      2. Laboratories posted at Biosafety Level 2 with Biosafety Level 3 Practices;
      3. Laboratories in which known carcinogens, reproductive toxins or other acutely toxic chemicals are being handled;
      4. Areas of high radiation or airborne radioactivity (as defined in 10 CFR 20.1003);
      5. Areas with active Class 3Bor 4 lasers;
      6. Nonhuman primate holding rooms; and
      7. Areas where procedures with awake nonhuman primates are conducted.

D. Responsibilities

  1. All NIH employees have a continuing responsibility to assure a safe work environment exists for themselves, their co-workers, visitors, Clinical Center patients and their guests.
  2. Employees: Any employee who brings a minor into work must have the necessary approval presented in this manual chapter.
  3. Supervisors: When notified that a minor will be in an area for which they are responsible, supervisors should conduct a risk assessment to determine if it is appropriate for the minor to enter. The IC Safety Specialist can assist with this assessment. The supervisor     should inform the Laboratory Director of the assessment and if any safety concerns exist. Supervisors are responsible for ensuring that employees who request to bring minors into workplaces covered by this manual chapter are aware of the requirements of this manual chapter and that proper approvals have been received.
  4. Laboratory Directors: Laboratory Directors are responsible for determining if an area is safe for a minor to enter. In addition, the Laboratory Director must provide written approval to the employee(s) requesting admittance of a minor to a hazardous area.  If the Laboratory Director has any safety concerns, they should contact the Division of Occupational Health Safety (DOHS) or the Safety Specialist assigned to the IC.
  5. Laboratory Supervisors: Laboratory supervisors will notify Laboratory Directors of requests to bring minors into the lab and will not permit minors in the work space unless the Laboratory Director has provided written approval for their admittance.
  6. Division of Occupational Health and Safety (DOHS): A Safety Specialist from the  DOHS is assigned to each IC. The Safety Specialists work to ensure a safe and healthy work environment by providing technical assistance and guidance. This includes working with IC personnel to assess potential risks associated with minors entering hazardous areas at the NIH.  The DOHS coordinates with program directors responsible for educational tours, including the annual “Take Your Child to Work Day”.

    Through this manual issuance, the Division of Occupational Health and Safety (DOHS), Office of Research Services is responsible for the methods used to ensure that internal controls are implemented and working. Compliance will be reviewed during worksite surveys and during annual IC Safety and Health surveys.

  7. Division of Radiation Safety (DRS): Is responsible for meeting the requirements set forth by the US Nuclear Regulatory Commission, Department of Transportation, and Occupational Safety and Health Administration. The DRS provides training, technical assistance, information and guidance on the safe and proper use of radiation at the NIH. The DRS (via the RSO) must review and approve all applications for minor employees prior to working with radiation.

The Radiation Safety Officer (RSO) is part of DRS and is responsible for reviewing applications for minors to enter areas where radioactive materials or equipment may be in use. The RSO also reviews requests for minors to work with radioactive materials (e.g., source vials) and grants written permission where requests are approved.

  1. Program awareness: DOHS will ensure awareness of this policy by integrating awareness training into DOHS sponsored training courses including, “Laboratory Safety at the NIH” and the annual “Laboratory Safety Refresher Course”, found at  www.safetytraining.nih.gov. The policy will also be presented to the Chairpersons of the IC Safety Committees for dissemination to the NIH community ORF personnel will be notified of this policy through periodic training required for all ORF personnel working in hazardous spaces.
  2. Requests for Admittance of Minors to Hazardous Areas: The following procedures apply for supervisors requesting admittance of minors to research laboratories:
    1. All hazardous areas. For a minor to work in any hazardous area at the NIH the supervisor must request written permission from the Laboratory Director or senior management (for mechanical or non-laboratory space). The Laboratory Director or manager, with guidance from DOHS, will evaluate the hazards in the space, and determine if it is appropriate for a minor to work in that area.
    2. Hazardous areas using radioactive materials or equipment. Prior to approval for minors to work around, or with, radioactive materials, an application must be submitted to the NIH RSO. Instructions for applying, the application, and other requirements for minors working with or near radioactive materials and equipment can be found on the DRS website at http://drs.ors.od.nih.gov/training/Pages/minor.aspx.
  3. Review of Internal Controls:
    1. Office Responsible for Reviewing Internal Controls Relative to This Chapter (Issuing Office) - Through this manual issuance, the Division of Occupational Health and Safety (DOHS), Office of Research Services is responsible for the methods used to ensure that internal controls are implemented and working. Compliance will be reviewed during worksite surveys and during the IC Safety and Health surveys.
    2. Frequency of Review - The DOHS will review the effectiveness of this program annually as part of the annual worksite surveys and IC Safety and Health surveys. More frequent evaluations will be performed if there are reports of problems.
    3. Method of Review - The DOHS will maintain oversight and ensure effective implementation and compliance with this policy. DOHS will solicit input from other responsible parties (e.g., DRS and CC Safety Officer, Office of Patient Safety and Clinical Quality) to ensure specific program needs of those organizations are addressed where feasible during annual safety inspections.

The DOHS will coordinate with relevant IC program directors responsible for educational tours, including the annual “Take Your Child to Work Day” and will survey participating laboratories and other worksites for any potential hazards.DOHS, DRS, and CC Safety Office staff will be responsible for surveying spaces that are part of their areas of responsibility (e.g., laboratories using radioactive materials for DRS or clinical spaces for CC Safety Office).

  1. Reviewed Reports are sent to - Reports should be sent as needed to the Office of Research Services (ORS) Director, the Deputy Director for Intramural Research (DDIR), and the Deputy Director for Management (DDM). Status reports for identified concerns should indicate that controls are in place and working well, or any internal management control issues that should be brought to the attention of the report recipient(s).
  1. NIH Policy Manual, Chapter 1743 Keeping and Destroying Records, available at:  https://policymanual.nih.gov/1743
  2. Title 10 of the Code of Federal Regulations, Chapter I- Nuclear Regulatory Commission, Part 20, Subpart A, Section 1003, Definitions; Section 1004, Units of Radiation Dose; Subpart C, Section 1201, Occupational dose limits for adults; Section 1207, Occupational dose limits for minors; and Subpart D, Section 1301, Dose Limits for Individual  Members of the Public.
  3. Biosafety in Microbiological and Biomedical Laboratories, U.S. DHHS, Centers for Disease Control and Prevention and National Institutes of Health. HHS Publication No. (CDC) 21-1112. 5th Edition.
  4. NIH Policy Manual, Chapter 1340 NIH Occupational Safety and Health Management, available at: https://policymanual.nih.gov/1340
  5. NIH Policy Manual, Chapter 1405 NIH Physical Access Control, available at:  https://policymanual.nih.gov/1405
  6. NIH Policy Manual, Chapter 2300-308-1 Guest Research/Special Volunteer Programs, available at: https://policymanual.nih.gov/2300-308-1
  7. NIH Policy Manual, Chapter 3034 Working with Hazardous Materials, available at:  https://policymanual.nih.gov/3034
  8. NIH Policy Manual, Chapter 3035 Working Safely with Potentially Hazardous Biological Materials, available at: https://policymanual.nih.gov/3035
  9. NIH Chemical Hygiene Plan
  10. NIH Clinical Center Policy and Communication Bulletin M92-10 of September 7, 2006.
  11. Deputy Director Intramural Research Letter “Additional Responsibilities and Training Requirements for Working with Nonhuman Primates,” Issued April 1997, signed by Dr. Michael Gottesman.
  12. Deputy Director Intramural Research Letter “Medical Clearance of Transient Visitors into NIH Animal Facilities,” Issued May 2015, signed by Dr. Michael Gottesman.

G. Definitions

  1. Hazardous Area – Any area that poses an actual or potential risk of illness or injury. At the NIH, the primary areas of concern are described in the Policy Section C.3.c. and d. of this chapter.
  2. Laboratory Director – Used in the same context as in “Biosafety in Microbiological and Biomedical Laboratories” (CDC/NIH, HHS No. 21-1112) to mean the officially designated supervisor (Branch Chief or Laboratory Chief) who has responsibility for all activities within a laboratory.
  3. Laboratory Supervisors - This may include Laboratory Chiefs, Branch Chiefs, Principle Investigation, or other NIH intramural program first-line supervisor.
  4. Minor – Any person under the age of 18.
  5. Office – A room which is physically separated from a laboratory. An office that is an integral part of a laboratory room will be considered to be laboratory space.
  6. Radiation Safety Officer (RSO) – A DRS individual, with authority delegated by the Director of Intramural Research, to approve minors working with or near potential radioactive sources.

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