+-----------------------------------+-----------------------------------+
| # Department of Veterans Affairs  | #  VHA HANDBOOK 1200.8            |
+-----------------------------------+-----------------------------------+
| # Veterans Health Administration  | #  Transmittal Sheet              |
+-----------------------------------+-----------------------------------+
| **Washington, DC 20420**          | **June 7, 2002**                  |
+-----------------------------------+-----------------------------------+

#### SAFETY OF PERSONNEL ENGAGED IN RESEARCH 

**1. REASON FOR ISSUE:** This Veterans Health Administration (VHA)
Handbook establishes policies for ensuring the safety of personnel
engaged in research.

**2. SUMMARY OF MAJOR CHANGES**

a\. Paragraph 1: Delineates range of risks to research personnel.

b\. Paragraph 2: Defines hazard categories.

c\. Paragraph 3: Provides general principles for ensuring safety in the
major hazard areas.

d\. Paragraph 4: Outlines responsibilities of personnel at Department of
Veterans Affairs (VA) medical centers.

e\. Paragraph 6: Provides key safety references.

**3. RELATED DIRECTIVE:** VHA Directive 1200, issued November 1, 2001.

**4. RESPONSIBLE OFFICE:** The Office of Research and Development (12)
is responsible for the contents of this VHA Handbook.

**5. RESCISSION:** This VHA Handbook rescinds VHA Handbook 1200.11 dated
August 22, 1997.

**6. RECERTIFICATION:** This document is scheduled for recertification
on or before the last working date of June 2007.

  ------------------------------- ---------------------------------------
                                  

                                  Robert H. Roswell, M.D.

                                  Under Secretary for Health
  ------------------------------- ---------------------------------------

  --------------- ------- ------------------------------------------------
  DISTRIBUTION:   CO:     E-mailed 6/10/2002

                  FLD:    VISN, MA, DO, OC, OCRO, and 200 -- E-mailed
                          6/10/2002
  --------------- ------- ------------------------------------------------

### CONTENTS

**SAFETY OF PERSONNEL ENGAGED IN RESEARCH**

# PARAGRAPH PAGE

1\. Purpose 1

2\. Definition of Hazard Categories 1

3\. Scope 2

4\. Responsibilities 3

5\. CRADO Risk Management Policies 9

6\. References 10

**APPENDIXES**

A Summary of Recommended Biosafety Levels for Infectious Agents A-1

B Infectious Disease Risk Assessment B-1

C Infrastructure of Subcommittee on Research Safety (SRS) C-1

D Format for Subcommittee on Research Safety Meeting Agendas

and Minutes D-1

E Radiation Safety E-1

F Laboratory Security and Emergency Response for Microbiological

and Biomedical Laboratories F-1

G VA Form 10-0398, Research Protocol Safety Survey G-1

H Contact Information H-1

#### SAFETY OF PERSONNEL ENGAGED IN RESEARCH

**1. PURPOSE**

Ensuring personnel safety in Veterans Health Administration (VHA)
research necessitates oversight at the national and local levels. This
VHA Handbook prescribes policies involving the use of potential hazards
encountered in these settings, including, but not limited to:

a\. Biohazards, such as:

\(1\) Pathogens and/or etiologic agents corresponding to Biosafety
Levels (BSL) 1-4, and

\(2\) Organisms and viruses containing recombinant deoxyribonucleic acid
(DNA) molecules.

b\. Chemical hazards.

c\. Physical hazards.

***NOTE:** This Handbook covers safety issues in research laboratories.
It is not intended to replace general occupational safety and health
policy applicable to all Department of Veterans Affairs (VA) employees,
whether or not involved with research, or to replace specific regulatory
programs mandated by law.*

**2.** **DEFINITION OF HAZARD CATEGORIES**

***NOTE:** Hazards encountered in research laboratories will vary among
medical centers according to the nature of research being conducted.
This variability does not affect the mandatory policies described in
this Handbook.*

a\. **[Biohazards]{.underline}.** Biohazards include, but are not
limited to, the following:

\(1\) Pathogens and/or etiologic agents, human and non-human primate
tissues including blood and body secretions, and human cell lines
corresponding to BSL 1-4 (see subpar. 6a);

\(2\) Toxins produced by microbial organisms (see Centers for Disease
Control and Prevention (CDC)-National Institutes of Health (NIH).
[Biosafety in Microbiological and Biomedical Laboratories 4^th^
Edition]{.underline} p. 237);

\(3\) Poisonous, toxic, parasitic and venomous animals or plants;

\(4\) Recombinant DNA molecules (see subpar. 6g.);

\(5\) Select agents, as specified in Title 42 Code of Federal
Regulations (see reference listed at paragraph 6.b);

\(6\) Animals experimentally or naturally exposed to any of the above
(see CDC-NIH. [Biosafety in Microbiological and Biomedical Laboratories
4^th^ Edition]{.underline} pp. 53-75).

b\. **[Chemical Hazards.]{.underline}** Chemical hazards include any
substance or mixture of substances with properties capable of producing
adverse effects on the health and/or safety of humans (see subpar.
6c(9)). Chemical hazard categories include, but are not limited to, the
following:

\(1\) Corrosives;

\(2\) Toxic substances (poisons, irritants, asphyxiates);

\(3\) Sensitizers;

\(4\) Carcinogens, mutagens and/or teratogens;

\(5\) Flammables; and

\(6\) Explosives.

c\. **[Physical Hazards.]{.underline}** Physical hazards include, but
are not limited to, the following (see subpar. 6c(4)):

\(1\) Ionizing and non-ionizing radiation (see App. E),

\(2\) Noise,

\(3\) Vibration,

\(4\) Extremes of temperature and pressure,

\(5\) Explosive hazards,

\(6\) Electrical hazards, and

\(7\) Mechanical hazards.

**3. SCOPE**

a\. Research laboratories are included in the medical center-wide
written occupational safety and health program. The role and
responsibilities of the research office is defined within this program.
Research offices must also maintain a Research Safety Program that is
consistent with VA policies, Federal statutes and regulations from
Occupational Safety and Health Administration (OSHA), the Environmental
Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), etc.,
and any applicable state and local requirements. All applicable National
Institutes of Health (NIH) and/or Centers for Disease Control and
Prevention (CDC) guidelines must be followed (see par. 6).

\(1\) **Biohazards**. The medical center research office must develop a
service-wide safety manual. It shall include a description of biohazard
controls (e.g., engineering, procedures and personal protective
equipment), emergency procedures, and an emergency cascade phone list
specific to the facility. This document must be updated, reviewed, and
approved annually by the Subcommittee on Research Safety (SRS) and
forwarded to the Research and Development (R&D) Committee for approval.
Individual laboratories must adhere to CDC and NIH safety and health
guidelines. Those laboratories that work at BSL 3 containment (see App.
A) must maintain a separate, written, regularly updated laboratory
manual that includes standard operating procedures and emergency
procedures, such as, but not limited to a: spill, power outage, or
breach of security.

\(a\) [Bloodborne Pathogens.]{.underline} The risk of exposure to
bloodborne pathogens will be minimized in the research setting by
ensuring that all research personnel are aware of, and utilize,
universal precautions in the handling of biologic fluids of any type
according to the specifications of the Bloodborne Pathogen Standard (see
subpar. 6c(7)). Similarly, the risk of exposure to airborne pathogens
such as Mycobacterium tuberculosis must be minimized and strict
adherence to all applicable Federal statutes, regulations, policies and
guidelines must be rigorously upheld (see subpar. 6c(3)).

\(b\) [Recombinant DNA Research]{.underline}

[1]{.underline}. VA investigators planning to conduct recombinant DNA
research must comply with the most current Guidelines for Research
involving Recombinant DNA Molecules (see subpar. 6g), regardless of the
source of research funding.

[2]{.underline}. It should be noted that all funded and unfunded
projects and proposals must be reviewed and approved according to the
procedures described in the most current NIH Guidelines for Research
involving Recombinant DNA Molecules. Local SRS and R&D Committee
approvals are also required.

\(2\) **Hazardous Chemicals and/or Waste.** This Handbook does not
address the policies relating to the management of hazardous chemicals
and/or waste in detail. However, the Research laboratory program must
ensure that all Federal and state occupational safety and health,
transportation and shipping, and environmental regulations are
adequately addressed. As an example, Federal regulations (see subpar.
6c(9)) require the development of a "chemical hygiene plan" and the
administration of this plan by a "chemical hygiene officer."

\(3\) **Physical Hazards**. Physical hazards are addressed in the
research safety program to minimize risk and ensure regulatory
compliance. Routine laboratory inspections by facility safety personnel
and research personnel must include a review of all potential physical
hazards. As needed, inspections must be coordinated with program
managers and/or technical experts such as the Radiation Safety Officer.

b\. The provisions of this handbook apply to all research that is
conducted completely or partially in VA facilities, conducted in
approved off-site locations and facilities and/or conducted by VA
researchers while on VA official duty time. The research may be VA
funded, funded from extra-VA sources, or conducted without direct
funding. As a minimum, facility safety personnel must verify that other
or remote facilities adhere to health and safety standards that are
equivalent to VA standards.

**4. RESPONSIBILITIES**

a\. **[Medical Center Director.]{.underline}** The medical center
Director is responsible for:

\(1\) Ensuring that the research safety program is staffed adequately
and that resources are available to maintain full compliance with all
applicable regulations and standards of safety.

\(2\) Ensuring that all Research personnel are included in the facility
Occupational Safety and Health program and that research space is
included in annual workplace inspections. ***NOTE:** Research personnel
must be covered by all other facility safety programs (e.g., respiratory
protection program, fire safety program, etc.).*

\(3\) Ensuring the resolution of any facilities-related deficiencies
identified in inspections.

\(4\) Providing engineering support in conducting ventilation
maintenance and validation of required specifications.

\(5\) Providing technical assistance of facility safety and health
professionals as needed.

\(6\) In cooperation with the Associate Chief of Staff (ACOS) for
Research and Development (R&D) or Coordinator for Research (C for R&D),
ensuring that measures for the security of the research laboratories and
surrounding space will be developed (see App. F).

\(7\) Providing adequate administrative support for SRS, including space
sufficient to provide privacy for conducting sensitive duties related to
biosafety, and the personnel to support the review and record-keeping
functions of SRS, and the timely preparation of investigator
correspondence and other documents.

b\. **[ACOS for R&D or C for R&D.]{.underline}** The ACOS for R&D or C
for R&D is responsible for:

\(1\) Ensuring that safety related communications from the Chief
Research and Development Officer (CRADO) are disseminated to appropriate
personnel in a timely manner after receipt.

\(2\) The responses to safety "holds."

\(3\) Ensuring that research activity ceases until a particular "hold"
is lifted.

\(4\) Continuously developing and evaluating performance standards of
the research safety program.

c\. **[R&D Committee]{.underline}**

\(1\) The R&D Committee must establish either an SRS or multiple
subcommittees dealing with different aspects of research safety. In some
instances alternate safety oversight and review mechanisms may be
developed with an affiliate safety committee or committees.

\(a\) Pre-approval by the CRADO is required to use such an alternate
mechanism.

\(b\) The alternate mechanism does not absolve the R&D Committee from
any responsibilities related to the SRS functions.

\(c\) If using the services of an external subcommittee, VA interests
must be adequately represented by the inclusion of at least one VA
employee with appropriate qualifications.

(d) The SRS must meet the requirements found in Appendix C.

\(2\) The R&D Committee is responsible for:

\(a\) Reviewing all R&D proposals.

[1]{.underline}. Ensuring the SRS review of those protocols and/or
submissions for funding that involve safety hazards to personnel and/or
the environment.

[2]{.underline}. Prior to review of a proposal, ensuring that a complete
list of chemicals designated or identified by OSHA and/or EPA as
"hazardous" (see subpar. 6c(8), subpar. 6e(2), and/or applicable state
requirements) has been reviewed and approved by the Safety Officer.
***NOTE:** This chemical inventory is reviewed and maintained locally;
and it is not submitted along with the research proposal for review in
VA Central Office.*

\(b\) Acting upon SRS recommendations for approval or non-approval of
reviewed proposals for submission to VA Central Office.

\(c\) Reviewing and acting upon SRS minutes.

\(d\) Appointing a Research Safety Coordinator who is responsible for
supervising and operating the Research Safety Program. Specific
responsibilities for this position must be specified in the written
local policy of the Research Safety Program. ***NOTE:** The ACOS for R&D
or C for R&D generally assumes this role.*

\(e\) Appointing a Biological Safety Officer [if]{.underline} research
is conducted at the facility involving:

[1]{.underline}. The use of recombinant DNA at BSL 3 or 4, or

[2]{.underline}. Large scale (greater than 10 liters of culture)
research or production activities involving viable organisms containing
recombinant DNA molecules (see subpar. 6g). ***NOTE:** This may require
establishing a "Biosafety Committee" according to the NIH Guidelines,
which may be merged into the SRS, if all specifications are met. In all
cases this committee or subcommittee must report to the R&D Committee
following review.*

\(f\) Ensuring the development and implementation of the laboratory
Chemical Hygiene Plan. Appointing a Chemical Hygiene Officer to provide
technical guidance on the implementation of the Plan. The Chemical
Hygiene Officer should be a standing member of the SRS.

\(g\) Overseeing compliance with this VHA Handbook by Principal
Investigators (PIs) conducting research at the facility.

\(h\) Ensuring the development and implementation of safety protocols by
the PI for individual research projects as needed.

\(i\) Ensuring that the Research Office provides support to the SRS to
assist in their functions.

\(j\) Ensuring that the minutes of SRS meetings are documented correctly
(see App. D), and maintained by the Research Office. ***NOTE:**
Periodically, the CRADO may request that SRS minutes from at least 2
previous quarters be forwarded to the VA Central Office Biosafety Office
for review.*

\(k\) Providing the ACOS for R&D or C for R&D, and facility or Veterans
Integrated Service Network (VISN) safety officials with adequate
information to evaluate the performance of the R&D safety program.

\(l\) Ensuring coordination with other regulatory programs or committees
such as the Radiation Safety Officer and/or Radiation Safety Committee.

\(m\) Reviewing accident and injury trends reported by SRS. Recommending
and ensuring the implementation of corrective action.

\(n\) Reviewing all citations issued by regulatory agencies and ensuring
that prompt corrective actions are taken by appropriate committee
members and PIs, and coordinating the necessary responses to regulatory
agencies.

d\. **[SRS.]{.underline}** SRS is responsible for:

\(1\) Reviewing all research activities involving biological, chemical,
physical, and radiation hazards for compliance with all applicable
regulations, policies, and guidelines prior to submission for R&D
funding. This includes a review of all research applications for funding
that will be conducted at the VA facility or by VA personnel with VA
funding located off-site.

\(a\) The review of the Research Protocol Safety Survey (RPSS) (see VA
Form 10-0398, App. G) must include a risk assessment of the facilities,
level of containment, laboratory procedures, practices, training and
expertise of personnel involved in the specific research conducted
including recombinant DNA research (see App. B).

\(b\) All research projects involving biological, chemical, physical,
and radiation hazards must be approved by SRS and then by the R&D
Committee prior to commencement. SRS must review proposed research at
convened meetings at which a quorum (majority of voting members) is
present. ***NOTE:** In order for the research to be approved, it must
receive the approval of a majority of those voting members present at
the meeting. A quorum must be maintained for each vote to occur. If a
quorum is not maintained, the protocol must be tabled and only
non-protocol related issues may be discussed.*

\(2\) Providing written notification of the results of SRS review to the
R&D Committee, the Research Office, and the PI.

\(3\) Annually reviewing [all]{.underline} active research protocols
involving biological, chemical, physical, and radiation hazards,
regardless of funding status or source. The date of continuing review
will be based on the date of SRS approval. Research protocol changes not
included in the original application must be documented on an amended
RPSS (see VA Form 10-0398, App. G) and must be submitted to and reviewed
by SRS prior to the implementation of the changes.

\(4\) Ensuring that a complete list of all products containing chemicals
designated or identified by OSHA and/or EPA as "hazardous" (see subpar.
6c(8), subpar. 6e(2), and/or applicable state requirements) has been
submitted to the Safety Officer for review and approval prior to the
submission of a protocol for local review.

\(5\) Coordinating all safety-related activities in research
laboratories including mandatory and non-mandatory training, safety
inspections, accident reporting, and liaison activities with all
facility safety committees and officials; to include:

\(a\) Coordinating follow-up evaluations to ensure that deficiencies
cited during inspections are permanently and effectively abated, and

\(b\) Reporting follow-up results to the R&D Committee.

\(6\) Reporting operational problems or violations of directives to the
Research Safety Coordinator and the Research Office within 30 days of
occurrence or detection, unless SRS determines that a report has been
previously filed by the PI.

\(7\) Identifying the need for health surveillance of personnel involved
in individual research projects; and if appropriate, advising R&D
Committee and Employee Health Practitioner on the need for such
surveillance.

\(8\) Maintaining adequate documentation of all SRS or equivalent
subcommittee activities.

\(9\) Forwarding minutes to the Research Office (see App. D).

\(10\) Ensuring that all laboratory personnel receive annual research
specific safety training.

\(11\) Holding SRS meetings at least quarterly.

\(12\) Ensuring coordination with other regulatory programs, personnel,
or committees, such as the Radiation Safety Officer and/or Radiation
Safety Committee.

\(13\) Ensuring the collection of appropriate personnel samples to make
employee exposure determinations whenever the proposed use of laboratory
chemicals may potentially exceed OSHA Permissible Exposure Limits or
Action Levels.

\(14\) Annually evaluating the effectiveness of the laboratory's
Chemical Hygiene Plan and making necessary revisions.

\(15\) Ensuring the review of investigation reports of all lost-time
injuries and all significant adverse environmental events.

\(16\) Ensuring the proper reporting of injury and illness trends to the
R&D Committee, as appropriate.

\(17\) When appropriate, requesting the appointment of an ad hoc
committee consisting of members with appropriate expertise, to
investigate and report on occupational injuries, illnesses, and adverse
environmental events.

\(18\) Ensuring the development of a policy for the preservation of
employee medical and OSHA exposure records (see subpar 6c(6)) and
environmental records (i.e., hazardous waste, air monitoring).

\(19\) Cooperating with appropriate medical center personnel to review
the quantity and type of hazardous waste generated by each PI annually.

\(20\) Providing technical assistance in the reduction of the quantity
of waste and/or recycling programs, where appropriate.

e\. **[PI or Laboratory Director.]{.underline}** The PI or Laboratory
Director is responsible for research activities conducted in assigned
space, including:

\(1\) Submitting a completed RPSS (see VA Form 10-0398, App. G) to the
medical center research office along with each research proposal to be
submitted for funding.

\(a\) The "Work Proposed" section of the research proposal must
accompany the survey.

\(b\) The research office arranges for review of the proposal and
evaluation by SRS.

\(c\) A complete list of chemicals defined as "hazardous" (see subpar.
4c(2)(a)[2]{.underline}. and subpar. 4d(4)) to be used must be submitted
with each research proposal. ***NOTE:** Not submitting such a list will
result in failure to obtain approval by the facility Safety Officer.
Review and approval by the Safety Officer is required prior to local
review of protocols by the R&D Committee.*

***NOTE:** This chemical inventory is reviewed and maintained locally.
It is not submitted with the research proposal for review in VA Central
Office.*

\(2\) Ensuring that active protocols and new pilot projects have been
reviewed by SRS, regardless of funding status or source.

\(3\) Identifying laboratory specific hazards, and:

\(a\) Ensuring that all personnel receive training specific to the
hazard(s).

\(b\) Advising laboratory personnel of any potential risk to themselves
or the research environment.

\(c\) Establishing and enforcing standards of practice which minimize
employee exposures to biological, chemical, physical, and radiation
hazards.

\(4\) Supervising the performance of the laboratory staff to ensure the
correct use of required safety practices and techniques (including
personal protective equipment).

\(5\) Ensuring that Biological Safety Cabinets are certified annually.
***NOTE:** In research settings involving airborne pathogens,
certification must be performed on a semi-annual basis.*

\(6\) Reporting problems and concerns about operation and containment
practices and procedures to the Research Safety Coordinator, facility
Safety Officer, Veterinary Medical Officer (VMO) or Veterinary Medical
Consultant (VMC) (if applicable), Radiation Safety Officer (if
applicable), and other appropriate authorities.

\(7\) Ensuring that all accidents are reported to the Employee Health
Office and the facility safety office using appropriate VHA forms.

\(8\) Securing approval of the R&D Committee through the SRS for any
significant changes made in the original research plan.

\(9\) Coordinating with appropriate safety staff such as the Radiation
Safety Officer for removal or disposal of all chemicals, biological
agents, radioisotopes, and waste generated by these materials.

\(10\) Notifying all pertinent personnel prior to departure from the
laboratory.

\(11\) Notifying all pertinent personnel prior to relocating the
research laboratory space.

\(12\) Ensuring that a copy of the laboratory's Chemical Hygiene Plan is
readily available to all employees in their work area, that employees
have been trained in the contents of the Plan and that all provisions of
the Plan are implemented in all laboratories under the PI's supervision.

\(13\) Maintaining employee exposure to hazardous chemicals in
laboratory activities at the lowest possible levels. At no time may
employee exposures to chemicals exceed the Permissible Exposure Limits
established by OSHA (see subpar. 6c(5)).

\(14\) Maintaining an up-to-date inventory of all hazardous chemicals
located in the laboratory.

\(a\) Ensuring that all laboratory personnel know the location of this
inventory.

\(b\) Providing this inventory to the facility Safety Officer.

\(15\) Managing all biological and chemical waste in accordance with
Federal, state, and local regulations and all VA, VHA, and facility
policies.

\(a\) Seeking technical assistance when needed to ensure proper waste
management.

\(b\) Implementing waste reduction techniques, where appropriate.

\(16\) Investigating the correct deficiencies cited during all
inspections of work areas. Submitting a written abatement plan for all
deficiencies cited during inspections to SRS within the specified time
limits.

**5. CRADO RISK MANAGEMENT POLICIES**

The CRADO is responsible for:

3.  

a\. Requiring the review of mandatory safety surveys by the Biosafety
Office prior to release of funding for any approved research proposals
(see VA Form 10-0398, App. G). ***NOTE:** Alternate safety surveys may
be submitted following a complete audit and approval of the local
research safety program by the CRADO.*

b\. Establishing standards for acceptance or non-acceptance of submitted
forms. ***NOTE:** Failure to meet these standards will result in an
administrative "hold."* The following is required:

4.  \(1\) The safety form is required for all submissions for funding.

    \(2\) Title of submission must correspond to the title listed on the
    form.

    \(3\) Information, including negative responses, must be completely
    and accurately entered on the form. No blank fields will be
    acceptable for submission.

\(4\) All authorized signatures and dates must be present and approval
must be within 12 months of submission.

c\. Establishing procedures for the field to respond to a Hazard "hold."

\(1\) The VA medical center receiving notification of the "hold" must
respond within 12 weeks of receipt.

\(2\) Responses must be forwarded to the VA Central Office Biosafety
Office (see App. H for additional information).

\(3\) Resubmission of a research proposal does not qualify as a
response, and will result in an automatic "hold." Review for that
funding cycle will proceed, but the application will not be reviewed the
following cycle until a response to the original "hold" has been
received and approved by the Biosafety Office.

d\. Requesting copies of SRS meeting minutes for review. The Biosafety
Office must review SRS minutes. ***NOTE:** Generally, such requests will
be for 2 to 4 quarters of meeting minutes and allows a month for
forwarding the minutes to VA Central Office.*

e\. Scheduling site visits when operational deficiencies in the safety
program are detected following new construction or renovation, or as
appropriate. Failure to correct deficiencies will result in withholding
research funds.

f\. Responding to a CDC notice of failure to comply with the Select
Agent Laboratory Registration Program. This is accomplished by a site
visit and/or by withholding research funds for the specific research
program. Failure to correct deficiencies will result in withholding
research funds.

**6. REFERENCES**

a\. CDC-NIH. [Biosafety in Microbiological and Biomedical Laboratories
4^th^ Edition]{.underline}. CDC-NIH, Washington, DC, 1999.

b\. Title 42 CFR Part 72, Interstate Shipment of Etiologic Agents.

\(1\) Title 42 CFR Part 72.6, Additional Requirements for Facilities
Transferring or Receiving Select Agents.

\(2\) Title 42 CFR Part 72, Appendix A, Select Agents.

c\. Title 29 CFR Part 1910, Occupational Safety and Health Standards.

\(1\) Title 29 CFR Part 1910.38, Employee Emergency Plans and Fire
Prevention Plans.

\(2\) Title 29 CFR Part 1910.134, Respiratory Protection.

\(3\) Title 29 CFR Part 1910.139, Respiratory Protection for m.
Tuberculosis.

\(4\) Title 29 CFR Part 1910.269, Electric Power Generation,
Transmission, and Distribution.

\(5\) Title 29 CFR Part 1910.1000, Subpart Z, Toxic and Hazardous
Substances.

\(6\) Title 29 CFR Part 1910.1020, Access to Employee Exposure and
Medical Records.

\(7\) Title 29 CFR Part 1910.1030, Bloodborne Pathogens.

\(8\) Title 29 CFR Part 1910.1200, Hazard Communication.

\(9\) Title 29 CFR Part 1910.1450, Occupational Exposure to Hazardous
Chemicals in Laboratories.

d\. Title 10 CFR Chapter 1, Nuclear Regulatory Commission, Parts 0-199.

\(1\) Title 10 CFR Part 19, Notices, Instructions and Reports to
Workers; Inspections and Investigations.

\(2\) Title 10 CFR Part 20, Standards for Protection Against Radiation.

\(3\) Title 10 CFR Part 35, Medical Use of Byproduct Material.

e\. Title 40 CFR Chapter 1, Environmental Protection Agency.

\(1\) Title 40 CFR Part 260, Hazardous Waste Management System:
General..

\(2\) Title 40 CFR Part 261, Identification and Listing of Hazardous
Waste.

\(3\) Title 40 CFR Part 262, Standards Applicable to Generators of
Hazardous Waste.

f\. "Radiologic Protection in Biomedical Research," [Annals of the
ICRP]{.underline}, Vol. 22, No., 3, 1991.

g\. "National Institutes of Health Guidelines for Research Involving DNA
Molecules," [NIH Guidelines]{.underline}. National Institutes of Health,
Bethesda, MD, May 11, 1999 http://www4.od.nih.gov/oba.

h\. VHA Directive 1105.1, Management of Radioactive Materials.

i\. VHA Handbook 1105.1, Procedures for Management of Radioactive
Materials.

j\. VHA Manual M-1, Part VII, Chapter 14, Waste Management, dated
September 19, 1994, or superseding VHA policy provision.

k\. VA Directive 7700, Occupational Safety and Health.

l\. National Council on Radiation Protection and Measurements reports:

\(1\) Number 107, Implementation of the Principle of As Low as
Reasonably Achievable (ALARA) for Medical and Dental Personnel
(Bethesda, MD, 1990), and

\(2\) Number 116, Limitation of Exposure to Ionizing Radiation
(Bethesda, MD, 1993).

## SUMMARY OF RECOMMENDED BIOSAFETY LEVELS FOR INFECTIOUS AGENTS

+---+---------------+---------------+---------------+----------------+
| * | ## Agents     | ## Practices  | **Safety      | ## Facilities  |
| * |               |               | Equipment**   |                |
| B |               |               |               | **(Secondary   |
| i |               |               | **(Primary    | Barriers)**    |
| o |               |               | Barriers)**   |                |
| - |               |               |               |                |
| S |               |               |               |                |
| a |               |               |               |                |
| f |               |               |               |                |
| e |               |               |               |                |
| t |               |               |               |                |
| y |               |               |               |                |
| L |               |               |               |                |
| e |               |               |               |                |
| v |               |               |               |                |
| e |               |               |               |                |
| l |               |               |               |                |
| * |               |               |               |                |
| * |               |               |               |                |
|   |               |               |               |                |
| # |               |               |               |                |
|   |               |               |               |                |
| ( |               |               |               |                |
| B |               |               |               |                |
| S |               |               |               |                |
| L |               |               |               |                |
| ) |               |               |               |                |
+---+---------------+---------------+---------------+----------------+
| 1 | Not known to  | Standard      | None required | Open bench top |
|   | consistently  | Mi            |               | sink required  |
|   | cause disease | crobiological |               |                |
|   | in healthy    | Practices     |               |                |
|   | adults.       |               |               |                |
+---+---------------+---------------+---------------+----------------+
| 2 | Associated    | BSL-1         | Primary       | BSL-1 plus:    |
|   | with human    | practices     | barriers =    |                |
|   | disease.      | plus:         | Class I or II | -   Autoclave  |
|   | Hazard:       |               | Biosafety     |     available  |
|   | percutaneous  | a\. Limited   | Cabinet       |                |
|   | injury;       | access.       | (BSC)s or     |                |
|   | ingestion;    |               | other         |                |
|   | mucous        | b\. Biohazard | physical      |                |
|   | membrane      | warning       | containment   |                |
|   | exposure.     | signs.        | devices used  |                |
|   |               |               | for all       |                |
|   |               | c\. "Sharps"  | manipulations |                |
|   |               | precautions.  | of agents     |                |
|   |               |               | that cause    |                |
|   |               | d\. Biosafety | splashes or   |                |
|   |               | manual        | aerosols of   |                |
|   |               | defining any  | infectious    |                |
|   |               | needed waste  | materials;    |                |
|   |               | de            | Personal      |                |
|   |               | contamination | Protective    |                |
|   |               | or medical    | Equipment     |                |
|   |               | surveillance  | (PPE)s:       |                |
|   |               | policies.     | laboratory    |                |
|   |               |               | coats;        |                |
|   |               |               | gloves; face  |                |
|   |               |               | protection as |                |
|   |               |               | needed        |                |
+---+---------------+---------------+---------------+----------------+
| 3 | Indigenous or | BSL-2         | Primary       | BSL-2 plus:    |
|   | exotic agents | practices     | barriers =    |                |
|   | with          | plus:         | Class I or II | a\. Physical   |
|   | potential for |               | BSCs or other | separation     |
|   | aerosol       | a\.           | physical      | from access    |
|   | transmission; | Controlled    | containment   | corridors.     |
|   | disease may   | access.       | devices used  |                |
|   | have serious  |               | for all open  | b\.            |
|   | or lethal     | b\.           | manipulations | Self-closing,  |
|   | consequences. | De            | of agents;    | double-door    |
|   |               | contamination | PPEs:         | access.        |
|   |               | of all waste. | protective    |                |
|   |               |               | lab clothing; | c\. Exhausted  |
|   |               | c\.           | gloves;       | air not        |
|   |               | De            | respiratory   | recirculated.  |
|   |               | contamination | protection as |                |
|   |               | of lab        | needed        | d\. Negative   |
|   |               | clothing      |               | airflow into   |
|   |               | before        |               | laboratory.    |
|   |               | laundering.   |               |                |
|   |               |               |               |                |
|   |               | d\. Baseline  |               |                |
|   |               | serum.        |               |                |
+---+---------------+---------------+---------------+----------------+
| 4 | Dangerous     | BSL-3         | Primary       | BSL-3 plus:    |
|   | and/or exotic | practices     | barriers =    |                |
|   | agents which  | plus:         | All           | a\. Separate   |
|   | pose high     |               | procedures    | building or    |
|   | risk of       | a\. Clothing  | conducted in  | isolated zone. |
|   | lif           | change before | Class III     |                |
|   | e-threatening | entering.     | BSCs or Class | b\. Dedicated  |
|   | disease;      |               | I or II BSCs  | supply and     |
|   | aeroso        | b\. Shower on | in            | exhaust,       |
|   | l-transmitted | exit.         | combination   | vacuum, and    |
|   | lab           |               | with          | d              |
|   | infections;   | c\. All       | full-body;    | econtamination |
|   | or related    | material      | air-supplied, | systems.       |
|   | agents with   | d             | positive      |                |
|   | unknown risk  | econtaminated | pressure      | c\. Other      |
|   | of            | on exit from  | personnel     | requirements   |
|   | transmission. | facility.     | suit          | outlined in    |
|   |               |               |               | the text.      |
+---+---------------+---------------+---------------+----------------+

Text taken from Biosafety in Microbiological and Biomedical
Laboratories; 4^th^ Edition, Pub. May 1999, Pg. 52.

**SUMMARY OF RECOMMENDED BIOSAFETY LEVELS FOR ACTIVITIES**

**IN WHICH EXPERIMENTALLY OR NATURALLY INFECTED VERTEBRATE ANIMALS ARE
USED**

+---+-----------+------------------+------------------+----------------+
| # | ## Agents | ## Practices     | **Safety         | ## Facilities  |
|   |           |                  | Equipment**      |                |
| B |           |                  |                  | **(Secondary   |
| S |           |                  | **(Primary       | Barriers)**    |
| L |           |                  | Barriers)**      |                |
+---+-----------+------------------+------------------+----------------+
| 1 | Not known | Standard animal  | As required for  | Standard       |
|   | to        | care and         | normal care of   | animal         |
|   | con       | management       | each species.    | facility:      |
|   | sistently | practices,       |                  |                |
|   | cause     | including        |                  | a\. No         |
|   | disease   | appropriate      |                  | recirculation  |
|   | in        | medical          |                  | of exhaust     |
|   | healthy   | surveillance     |                  | air.           |
|   | human     | programs.        |                  |                |
|   | adults.   |                  |                  | b\.            |
|   |           |                  |                  | Directional    |
|   |           |                  |                  | air flow       |
|   |           |                  |                  | recommended.   |
|   |           |                  |                  |                |
|   |           |                  |                  | c\. Hand       |
|   |           |                  |                  | washing sink   |
|   |           |                  |                  | recommended.   |
+---+-----------+------------------+------------------+----------------+
| 2 | A         | Animal Biosafety | ABSL-1 equipment | ABSL-1         |
|   | ssociated | Level (ABSL)-1   | plus primary     | facility plus: |
|   | with      | practices plus:  | barriers:        |                |
|   | human     |                  |                  | a\. Autoclave  |
|   | disease.  | a\. Limited      | Have containment | available.     |
|   | Hazard:   | access.          | equipment        |                |
|   | per       |                  | appropriate for  | b\. Hand       |
|   | cutaneous | b\. Biohazard    | animal species;  | washing sink   |
|   | exposure; | warning signs.   | PPEs: laboratory | available in   |
|   | i         |                  | coats, gloves,   | the animal     |
|   | ngestion; | c\. "Sharps"     | face and         | room.          |
|   | mucous    | precautions.     | respiratory      |                |
|   | membrane  |                  | protection as    | c\. Mechanical |
|   | exposure. | d\. Biosafety    | needed.          | cage washer    |
|   |           | manual.          |                  | used.          |
|   |           |                  |                  |                |
|   |           | e\.              |                  |                |
|   |           | Decontamination  |                  |                |
|   |           | of all           |                  |                |
|   |           | infectious       |                  |                |
|   |           | wastes and of    |                  |                |
|   |           | animal cages     |                  |                |
|   |           | prior to         |                  |                |
|   |           | washing.         |                  |                |
+---+-----------+------------------+------------------+----------------+
| 3 | I         | ABSL-2 practices | ABSL-2 equipment | ABSL-2         |
|   | ndigenous | plus:            | plus:            | facility plus: |
|   | or exotic |                  |                  |                |
|   | agents    | a\. Controlled   | a\. Containment  | a\. Physical   |
|   | with      | access.          | equipment for    | separation     |
|   | potential |                  | housing animals  | from access    |
|   | for       | b\.              | and cage dumping | corridors.     |
|   | aerosol   | Decontamination  | activities.      |                |
|   | tran      | of clothing      |                  | b\.            |
|   | smission; | before           | b\. Class I or   | Self-closing,  |
|   | disease   | laundering.      | II BSCs          | double-door    |
|   | may have  |                  | available for    | access.        |
|   | serious   | c\. Cages        | manipulative     |                |
|   | health    | decontaminated   | procedures       | c\. Sealed     |
|   | effects.  | before bedding   | (inoculation,    | penetrations.  |
|   |           | removed.         | necropsy) that   |                |
|   |           |                  | may create       | d\. Sealed     |
|   |           | d\. Disinfectant | infectious       | windows.       |
|   |           | foot bath as     | aerosols. PPEs:  |                |
|   |           | needed.          | appropriate      | e\. Autoclave  |
|   |           |                  | respiratory      | available in   |
|   |           |                  | protection.      | facility.      |
+---+-----------+------------------+------------------+----------------+
| 4 | Dangerous | ABSL-3 practices | ABSL-3 equipment | ABSL-3         |
|   | and/or    | plus:            | plus:            | facility plus: |
|   | exotic    |                  |                  |                |
|   | agents    | a\. Entrance     | -   Maximum      | a\. Separate   |
|   | that pose | through change   |     containment  | building or    |
|   | high risk | room where       |     equipment    | isolated zone. |
|   | of        | personal         |     (i.e., Class |                |
|   | life-th   | clothing is      |     III BSC or   | b\. Dedicated  |
|   | reatening | removed and      |     partial      | supply and     |
|   | disease;  | laboratory       |     containment  | exhaust,       |
|   | aerosol   | clothing is put  |     equipment in | vacuum, and    |
|   | tran      | on; shower on    |     combination  | d              |
|   | smission; | exiting.         |     with full    | econtamination |
|   | or        |                  |     body,        | systems.       |
|   | related   | b\. All wastes   |     air-supplied |                |
|   | agents    | are              |     p            | c\. Other      |
|   | with      | decontaminated   | ositive-pressure | requirements   |
|   | unknown   | before removal   |     personnel    | outlined in    |
|   | risk of   | from the         |     suit) used   | the text.      |
|   | tran      | facility.        |     for all      |                |
|   | smission. |                  |     procedures   |                |
|   |           |                  |     and          |                |
|   |           |                  |     activities   |                |
+---+-----------+------------------+------------------+----------------+

Text taken from Biosafety in Microbiological and Biomedical
Laboratories; 4^th^ Edition, Pub. May 1999, Pg. 75.

**INFECTIOUS DISEASES RISK ASSESSMENT**

Risk implies the [probability]{.underline} that harm, injury, or disease
will occur. In the context of the microbiological and biomedical
laboratories, the assessment of risk focuses primarily on the prevention
of laboratory-associated infections. Choosing the proper level of
containment is very important to reduce the employee's and the
environment's risk of exposure to an agent to an absolute minimum. Risk
assessment can be quantitative or qualitative**.** If the hazard is
known (e.g., residual levels of formaldehyde gas after a laboratory
decontamination), a quantitative assessment is possible. For the most
part, it is not possible to do a quantitative assessment of biohazardous
agents. A number of factors and considerations for a qualitative risk
assessment follow:

**1. ASSESSMENT OF RISK.** The Laboratory Director or Principal
Investigator (PI) is responsible for assessing risks.

a\. **[Factors of Interest.]{.underline}** The factors of interest must
include:

\(1\) Pathogenicity of the infectious or suspected infectious agent,

\(2\) Route of transmission,

\(3\) Agent stability,

\(4\) Infectious dose,

\(5\) Concentration,

\(6\) Origin,

\(7\) Availability of data from animal studies,

\(8\) Availability of an effective prophylaxis,

\(9\) Medical surveillance, and

\(10\) An evaluation of experience and skill level of at-risk personnel.

b\. **[Materials Containing Known Infectious Agents]{.underline}.** Use
the:

\(1\) Information obtained from laboratory investigations, disease
surveillance, and epidemiological studies.

\(2\) Infectious agents listed in Agent Summary Statements (Section VII)
of BMBL and American Public Health Association's manual, Control of
Communicable Diseases.

c\. **[Materials Containing Unknown Infectious Agents]{.underline}.**
Questions to be considered in establishing the appropriate biosafety
level:

\(1\) Why is an infectious agent suspected?

\(2\) What epidemiological data available?

\(3\) What route of transmission indicated?

\(4\) What is the associated morbidity and/or mortality rate?

\(5\) What medical data available?

d\. **[Materials Containing Recombinant Deoxyribonucleic Acid (DNA)
Molecules.]{.underline} *NOTE: ****This includes microorganisms that
have been genetically modified through recombinant DNA technologies.*

\(1\) Use appropriate reference for establishing appropriate biosafety
level: National Institutes of Health publication, [Guidelines for
Research Involving Recombinant DNA Molecules.]{.underline}

\(2\) Evaluate the potential increased biohazard associated with a
particular genetic modification.

\(3\) Select the appropriate biosafety level begins by classification of
non-modified virus. Carefully consider the nature of genetic
modification and quantity of virus when selecting appropriate biosafety
level.

\(4\) Consider the following points:

\(a\) Does inserted gene encode known toxin or relatively
uncharacterized toxin?

\(b\) Does modification have potential to alter host range or cell
tropism of virus?

\(c\) Does modification have potential to increase replication capacity
of virus?

\(d\) Does viral DNA integrate into host genome?

\(e\) What is probability of generating replication-competent viruses?

> e\. **[Materials that May or May Not Contain Unknown Infectious
> Agents.]{.underline}** Always use universal precautions when there is
> no information that an infectious agent is suspected.
>
> f\. **[Animal Studies.]{.underline}** Animal studies:
>
> \(1\) May present many different kinds of physical, environmental, and
> biological hazards.
>
> \(2\) Are unique according to species involved and the nature of the
> research.
>
> \(3\) Need to focus on the animal facility's potential for increased
> exposure to both human pathogens and to zoonotic agents.
>
> \(4\) Need to consider that latent infections most common in
> field-captured animals or animals come from unscreened herds.
>
> \(5\) Must consider animal routes of transmission.

***NOTE:** The described risk assessment process also applies to
laboratory operations other than those involving use of primary agents
of human disease such as chemical hazards.*

**2. REFERENCES**

a\. Richmond, Jonathan Y., and McKinney, Robert W., Editors. "Biosafety
in Microbiological and Biomedical Laboratories," [Public Health
Service]{.underline}, 4^th^ Edition, May, 1999. Risk Assessment,
V:76-83.

b\. Knudsen, R.C. 1998. Risk Assessment for Biological Agents in the
Laboratory. In J.Y. Richmond, Ph.D., R.B.P. (ed.) [Rational Basis for
Biocontainment: Proceedings of the Fifth National Symposium on
Biosafety]{.underline}. American Biological Safety Association,
Mundelein, IL.

c\. Benenson, Abram S., Editor. [Control of Communicable Diseases
Manual]{.underline}. 16^th^ Edition, 1995. American Public Health
Association, Washington, D.C. 20005.

d\. Collins, C.H. [Laboratory-acquired Infections, History, Incidence,
Causes and Prevention]{.underline}. Butterworths, and Co. Ltd. 1983.

e\. Richmond, Jonathan Y., and McKinney, Robert W., Editors. "Biosafety
in Microbiological and Biomedical Laboratories," [Public Health
Service]{.underline}, 3^rd^ Edition, May, 1993.

f\. Sewell, David L. "Laboratory Associated Infections and Biosafety,"
[Clinical Microbiology Reviews]{.underline}, 8:389-405, 1995.

g\. Sulkin, S.E., Pike, R.M. 1949. "Viral Infections Contracted in the
Laboratory," [New England Journal of Medicine]{.underline}. 241:205-213.

h\. Sulkin, S. E., Pike, R.M. 1951. "Survey of Laboratory Acquired
Infections," [American Journal of Public Health.]{.underline}
41:769-781.

i\. Sullivan J.F. Songer, J.R., Estrem, I.E. 1978. "Laboratory acquired
infections at the National Animal Disease Center," 1960-1975. [Health
Laboratory Science.]{.underline} 15:58-64.

j\. National Institutes of Health. Guidelines for Research Involving
Recombinant DNA Molecules. (Washington:GPO, 1998) [Federal
Register]{.underline}. 59FR34496.

**3. OTHER RESOURCES**

a\. NIH Guidelines for Recombinant DNA Molecules:

<http://www.NIH.gov/od/orda/toc.html>

b\. NIH Office of Biotechnology Activities:

[http://www4.od.nih.gov/oba](http://www.NIH.gov/od/orda)

**INFRASTRUCTURE OF SUBCOMMITTEE ON RESEARCH SAFETY (SRS)**

It is recommended that the Subcommittee on Research Safety (SRS) include
member(s) from the facility safety committee, such as the Safety Officer
or the Facility Infection Control Committee; the Institutional Animal
Care and Use Committee (IACUC); the Radiological Safety Officer; and a
liaison from an affiliated university Institutional Biosafety Committee.
Such individuals may be included in the core five members referred to in
subparagraph 1a of this Appendix.

**1.** **[Number and Qualification of Members]{.underline}**

a\. Each SRS must have at least five members, exclusive of ex-officio
members; this must include two members not affiliated with the
Institution, when the research reviewed involves recombinant
deoxyribonucleic acid (DNA) not exempt from the current National
Institutes of Health (NIH) Guidelines for Research Involving Recombinant
DNA Molecules.

b\. It will usually be necessary for the SRS membership to possess
expertise in:

\(1\) Etiologic agents, including bloodborne and airborne pathogens.

\(2\) Chemical carcinogens and other chemical hazards.

\(3\) Physical and radiation hazards.

c\. It is recommended that at least one SRS member possess specific
occupational safety and health, environmental, and Department of
Transportation expertise to ensure that all pertinent hazards in
protocols are identified. It is also advisable this member have first
hand knowledge of the space and facilities assigned to each Principal
Investigator (PI) to ensure that research operations can be conducted
safety.

d\. It is highly desirable that the Veterinary Medical Officer (VMO),
Veterinary Medical Consultant (VMC), or a member of the IACUC be
appointed to SRS.

**2. [Ex-Officio Members.]{.underline}** Ex-officio members must
include:

a\. A liaison member from the local Research and Development (R&D)
Committee (voting).

b.  The Chemical Hygiene Officer (appointed by the R&D Committee)
    (voting).

c\. The Administrative Officer (AO) for R&D or other non-voting
representative from the R&D office.

d\. An employee union safety representative, or other union designee,
whose voting status is determined by the applicable union contract.

**3. [Appointment of Members]{.underline}**

a\. SRS members and R&D Committee members forward the names of nominees
for membership in SRS to the medical center Director. The medical center
Director must officially appoint members in writing. ***NOTE:** In
addition, the length of the appointment needs to be specified.*

b\. The medical center Director appoints the SRS chairperson for the
term of 1 year. The SRS Chairperson may be re-appointed without any
lapse in time; however the SRS chairperson may not simultaneously chair
the R&D Committee or another research subcommittee.

**4.** **[Representatives from Other Medical Center Committees and/or
Offices.]{.underline}** If the facility conducts research with
recombinant DNA, it must comply with all requirements with respect to
composition of an Institutional Biosafety Committee as specified in the
[NIH Guidelines]{.underline}.

## FORMAT FOR SUBCOMMITTEE ON RESEARCH SAFETY 

## MEETING AGENDAS AND MINUTES

Agendas and minutes of the Subcommittee on Research Safety (SRS) must be
prepared according to the following format.

**1. AGENDA.** An agenda is to be developed before each SRS meeting and
distributed to SRS members at least 3 working days before the meeting.
At a minimum, the agenda is to include:

a\. Approval of minutes of previous meeting (date).

b\. Unfinished Business (list pending items and individual responsible).

c\. New Business (identify individual responsible when necessary).

\(1\) Standing recurring reports (identify individual responsible).

\(2\) Issues not previously addressed by the body.

\(3\) **Other.** Any other item that warrants review and/or discussion
by the committee and is not routinely reviewed by the committee.

d\. Announcements.

2.  e\. Date, time, and place of the next meeting.

**2. MINUTES:** Minutes of all SRS meetings must be prepared according
to the following format.

a\. Identification of the subcommittee to be centered at the top of the
page, including the Department of Veterans Affairs (VA) medical center
name and number.

b\. The first paragraph is to include:

\(1\) Place, date, and time of the meeting.

\(2\) Name of presiding officer (chairperson).

\(3\) **List of Attendees.** The attendance record must list all
individuals identified as members. Members are to be marked
"[Absent,"]{.underline} if Chairperson or recorder has not been notified
in advance. Members are to be marked "[Excused]{.underline}," if the
Chairman or recorder was notified in advance. For each member, note
their role on the committee and whether they are voting or non-voting.

\(4\) Indication that a quorum is present. ***NOTE:** A quorum is
defined as more than 50 percent of the voting members are present.*

c\. Succeeding paragraphs are to identify the recommendations, date of
the meeting when the recommendation was initially made, action taken to
date or a realistic date to expect resolution, and the status as
"Closed**"** or "Pending." For each project under consideration, list
the name of the Principal Investigator and the complete name of the
project.

***NOTE**: A recommendation is not to be carried for more than two
meetings awaiting a resolution unless there is clear documentation that
a plan of action is being followed and an anticipated date for
resolution is noted.*

d\. Minutes are not to be recorded verbatim except for recommendations;
however, the substance of the discussion is to be reported clearly and
concisely. After summation of the discussion, the minutes must reflect:

\(1\) **Conclusion.** This indicates what was concluded from the
discussion? (Example: "The follow-up action plan was ineffective, and
the issue is not considered resolved at this time.") If analysis of the
data occurred in the meeting, then the conclusion of the analysis needs
to be in the minutes.

\(2\) **Recommendation.** This includes who or what is expected to
change.

\(3\) **Action.** This includes what action is appropriate in view of
the cause, scope, and severity of the problem and who is responsible for
implementing the action.

\(4\) **Follow-Up and/or Evaluation.** This identifies the date a status
report is due on the action plan, the date the action plan will be
implemented, or the date the action plan will be evaluated for
accomplishment of expected outcome and/or impact of the changes made.

e\. For each new project, the motion passed by the committee (approved,
approved pending clarification, deferred, disapproved) must be recorded
with the exact vote; this must include the number voting for the motion,
the number voting against the motion, and the number abstaining from
voting on the motion. The motion needs to be worded in such a way that
it is clear which members will review revisions and have the authority
to grant approval.

f\. The minutes must note which members excused themselves from voting
on which project(s) to prevent conflicts of interest.

g\. Copies of any internal or external reports or correspondence with
outside agencies referenced in the minutes need to be attached to the
minutes if they are important to understanding the conduct of business.

h\. SRS members having a scientific or monetary conflict of interest for
the protocol under consideration may provide information helpful to the
SRS prior to deliberations, but must excuse themselves from the meeting
once deliberations begin.

i\. Minutes must be written and published within 3 weeks of the meeting
date.

j\. Minutes must be signed by the Chairperson of the SRS.

k\. Approved minutes must be forwarded to the Research and Development
(R&D) Committee for review and approval. The R&D Committee may review
the minutes for content regarding committee functions, protocol review,
education of members, and preparation of minutes. Recommendations for
changes or improvements in SRS procedures may be made, but the R&D
Committee may not alter the SRS minutes.

l\. Minutes must be maintained by the R&D Office and made available to
VA Central Office upon request.

**RADIATION SAFETY**

**1**. The use of radioactive materials within Department of Veterans
Affairs (VA) facilities must comply with the statutory and regulatory
requirements of the Nuclear Regulatory Commission (NRC) and with
Veterans Health Administration (VHA) policies and procedures for the
safety and control of such materials. These policies, procedures, and
regulations collectively control the receipt, uses, and disposal of
radioactive materials in the VHA research programs.

**2.** X-ray devices and their uses, while generally not subject to
regulation in Federal facilities, are nevertheless subject to actual
standards of practice and the important recommendations of influential
national and international councils and commissions. Specific details of
local facility requirements are approved and published by a facility
Radiation Safety Committee (RSC) and implemented by the Radiation Safety
Officer (RSO). The RSC and the RSO are the primary facility resources
for ensuring safe and effective uses of ionizing radiation in research
and always need to be consulted.

**3.** While Federal regulation and the weight of authoritative
commissions establish upper limits for the permissible radiation dose to
workers and the public, one of the most effective tools for education on
dosage is the facility specific As Low As Reasonably Achievable (ALARA)
programs. This is a mandatory commitment to maintain individual and
collective radiation doses as low as reasonably achievable and requires
participation of management, safety personnel, and individual research
users.

**4. REFERENCES**

a\. VHA Directive 1105.1, Management of Radioactive Materials.

b\. Handbook 1105.1, Procedures for Management of Radioactive Materials.

c\. Title 10 Code of Federal Regulations (CFR) Chapter 1, Nuclear
Regulatory Commission, Parts 0-199.

\(1\) Title 10 CFR Part 19, Notices, Instructions and Reports to
Workers; Inspections, and Investigations.

\(2\) Title 10 CFR Part 20, Standards for Protection Against Radiation.

\(3\) Title 10 CFR Part 35, Medical use of Byproduct Material.

# LABORATORY SECURITY AND EMERGENCY RESPONSE FOR

## MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES

The following are offered as guidelines for laboratories [using
biological agents or toxins capable of causing serious or fatal illness
to humans or animals and for the use of radioactive
materials]{.underline}**.** Research, clinical, and production
laboratories working with newly identified human pathogens, high-level
animal pathogens, and/or toxins not covered by Biosafety Level (BSL) 3
or 4 recommendations, also need to follow these guidelines to minimize
opportunities for accidental or intentional removal of these agents from
the laboratory.

**1. Recognize that laboratory security is related to but different than
laboratory safety.**

a\. Review safety policies and procedures regularly.

\(1\) Management needs to: review policies to ensure that they are
adequate for current conditions and consistent with other facility-wide
policies and procedures.

\(2\) Laboratory supervisors need to ensure that all laboratory workers
and visitors understand security requirements and are trained and
equipped to follow established procedures.

b\. Review safety policies and procedures whenever an incident occurs or
a new threat is identified.

**2. Control access to areas where biological agents or toxins are used
and stored.**

a\. Laboratory and animal care areas are to be locked at all times.

b\. Card-keys or similar devices are to be used to permit entry to
laboratory and animal care areas.

c\. Only workers required to perform a job are to be allowed in
laboratory areas, and workers need to be allowed only in areas and at
hours required to perform their particular job.

\(1\) Access for students, visiting scientists, etc., is to be limited
to hours when regular employees are present.

\(2\) Access for routine cleaning, maintenance, and repairs is to be
limited to hours when regular employees are present.

d\. Freezers, refrigerators, cabinets, and other containers where stocks
of biological agents, hazardous chemical, or radioactive materials are
stored are to be locked when they are not in direct view of workers
(e.g., when located in unattended storage areas).

**3. Know who is in the laboratory area.**

a\. All workers are to be known to facility administrators and
laboratory directors.

b\. All workers (including students, visiting scientists, and other
short-term workers) are to wear visible identification badges.

c\. Guests are to be issued identification badges, and escorted or
cleared for entry using the same procedures as for regular workers.

d\. All workers are to challenge or question unknown, unfamiliar or
unidentified persons in the laboratory area.

**4. Know what materials are being brought into the laboratory area.**
Packages containing specimens, bacterial or virus isolates, or toxins
are to be opened in a safety cabinet or other appropriate containment
device.

**5. Know what materials are being removed from the laboratory area.**

a\. Biological materials and/or toxins for shipment to other
laboratories are to be packaged and labeled in conformance with all
applicable local, federal, and international shipping regulations.

\(1\) Required permits (e.g., Public Health Service, Department of
Transportation, Department of Commerce, Department of Agriculture) are
to be in hand before materials are prepared for shipment.

\(2\) The recipient (preferably) or receiving facility is to be known to
the sender, and the sender should make an effort to ensure that
materials are shipped to a facility equipped to handle those materials
safely.

b\. Hand carrying of microbiological materials and toxins to other
facilities is rarely appropriate. If biological materials or toxins are
to be hand carried on common carriers, all applicable regulations
[must]{.underline} be followed.

c\. Contamination or possibly contaminated materials are to be
decontaminated before they leave the laboratory area. Chemicals and
radioactive materials must be disposed of in accordance with local,
state, and Federal regulations.

**6. Have an emergency plan.**

a\. Control of access to laboratory areas can make an emergency response
more difficult. This must be considered when emergency plans are
developed.

\(1\) An evaluation of the laboratory area by appropriate facility
personnel, with outside experts if necessary, to identify both safety
and security concerns needs to be conducted before an emergency plan is
developed.

\(2\) Facility administrators, laboratory directors, principal
investigators, laboratory workers, the facility safety office, and
facility security officials need to be involved in emergency planning.

\(3\) Police, fire, and other emergency responders need to be informed
as to the types of biological radioactive and chemical materials in use
in the laboratory areas, and they need to be assisted in planning their
responses to emergencies in the laboratory areas.

\(4\) Plans are to include provision for immediate notification of (and
response by) laboratory directors, laboratory workers, safety office
personnel, or other knowledgeable individuals when an emergency occurs,
so that biosafety issues can be dealt with, if they occur.

b\. In accordance with standards established by the Occupational Safety
and Health Administration (OSHA), the emergency plan must include, at a
minimum, the following elements (see Title 29 Code of Federal
regulations (CFR) 1910.38):

\(1\) Emergency escape procedures and emergency escape route
assignments;

\(2\) Procedures to be followed by employees who remain to operate
critical plan operations before they evacuate;

\(3\) Procedures to account for all employees after emergency evaluation
has been completed;

\(4\) Rescue and medical duties for those employees who are to perform
them;

\(5\) The preferred means of reporting fires and other emergencies; and

\(6\) Names or regular job titles of persons or departments who can be
contacted for further information or explanation of duties under the
plan.

c\. Laboratory emergency planning is to be coordinated with
facility-wide plans. Such factors as bomb threats, severe weather
(hurricanes, floods), earthquakes, power outages, and other natural (or
unnatural) disasters need to be considered when developing laboratory
emergency plans

**7. Have a protocol for reporting incidents.** Laboratory directors, in
co-operation with facility safety and security officials, are to have
policies and procedures in place for reporting and investigation of
incidents, or possible incidents (e.g., undocumented visitors, missing
chemicals, unusual or threatening phone calls).

**8. References**

a\. Torok TJ, et al. "A Large Community Outbreak of Salmonellosis Caused
by Intentional Contamination of Restaurant Salad Bars," [Journal of the
American Medical Association]{.underline} ([JAMA]{.underline}) 1997;
Vol. 278; 389-395.

b\. Kolavic SA, et al. "An Outbreak of Shigella dysenteriae Type 2 Among
Laboratory Workers Due to Intentional Food Contamination,"
[JAMA]{.underline} 1997; Vol. 278; 396-398.

c\. Report to Congress on Abnormal Occurrences which occurred between
July and September 1995, 3^rd^ Event: NIH Incident, [Federal
Register]{.underline}, February 26, 1996; Vol. 61, No. 38; 7123-7124.

d\. U.S. Nuclear Regulatory Commission, NUREG 1535, Ingestion of
Phosphorus-32 at MIT, Cambridge, MA Identified on August 19, 1995.

e\. U.S. Nuclear Regulatory Commission, Preliminary Notification of
Event or Unusual Occurrence PNO-1-98-052, Subject: Intentional Ingestion
of Iodine-125 Tainted Food (Brown University), November 16, 1998.

f\. National Institutes of Health (NIH) Issuance of Director's Decision:
The NIH Incident, [Federal Register]{.underline}, September 24, 1997, 62
(185): 50018-50033.

g\. Atlas RM, "Biological Weapons Pose Challenge for Microbiology
Community," [ASM]{.underline} [News]{.underline} 1998; Vol. 64; 383-389.

h\. Ruys, Theodorus, "Laboratory Design Principles" In: [Handbook of
Facilities Planning]{.underline}. Ruys, T, ed. New York: Van Nostrand
Reinhold, 1990; 257-264.

i\. U.S. Public Health Service. Final Rule: Additional Requirements for
Facilities Transferring or Receiving Select Agents. [Federal
Register.]{.underline} Oct. 24, 1996; 61 FR 29327.

***NOTE:** Excerpts taken from [Biosafety in Microbiological and
Biomedical Laboratories]{.underline}; 4^th^ Edition, Published May 1999,
pp. 224-228.*

# VA FORM 10-0398, RESEARCH PROTOCOL SAFETY SURVEY

Below is an embedded copy of Department of Veterans Affairs (VA) Form
10-0398. This form can also be found on the Veterans Health
Administration (VHA) Forms Intranet at
<http://vaww.va.gov/forms/medical/searchlist.asp>*.* This is to be used
for local reproduction.

Since this is a low use form, it will not be stocked by the Forms and
Publications Depot.

You should use Adobe Acrobat 4.0 or later to view this form. To print
this form, your printer must be set to "print as image" and "fit to
page."

![](media/image1.wmf)

# 

# CONTACT INFORMATION

1\. Inquiries regarding biosafety issues are to be directed to:

Phone: 301-737-4602

Fax: 301-737-6413

e-mail: drobbins@vairo.org

2\. Information forwarded by mail is to be addressed to:

Department of Veterans Affairs Infrastructure Review Office

Biosafety Office

23330 Cottonwood Parkway

Suite 345

California, MD 20619