Occupational Health and Safety Programs:: An AAALAC Perspective

Occupational Health
and Safety Programs:

An AAALAC Perspective
Section 1
Elements of an
Occupational Health Program:
Deficiencies identified by AAALAC.
David DeLong, D.V.M.

Chief, Veterinary Medical Unit
VAMC, Minneapolis, Minnesota
Elements of an OHS program:
Deficiencies identified by AAALAC
Why does AAALAC assess

occupational health and safety programs?
According to the Guide -

“An occupational health and safety
program must be part of the overall
animal care and use program."
Working with animals

can be dangerous business!

 Physical and chemical hazards
 Protocol related hazards
 Allergens
 Zoonotic diseases
How does
AAALAC assess an OHS program?

 Prior to the site visit, review the
Program Description.
 During the site visit, review facilities

and documents; interview personnel.
The Guide is the basis for the review.

Other documents:

 Occupational Health and Safety in the Care and
Use of Research Animals. 1997. NRC, National
Academy of Sciences.

 Biosafety in Microbiological and Biomedical
Laboratories. 1999. HHS Pub. No.
(CDC) 93-8395.

 Miscellaneous AAALAC resource documents.
What are the required

components of an OHS program?

 Risk assessment and hazard identification.
 Training.
 Personal hygiene and personal

protective equipment.
 Facilities, procedures, and monitoring.
 Medical evaluation and preventive medicine.

What are the hallmarks

of a successful program?

 Strong administrative support.
 Sound implementation strategies.
 Effective coordination of program components.

What trends in OHS Program

deficiencies
have been identified by AAALAC?
Occupational Health and Safety of Personnel
120
100
80
60 Mandatory
Suggestion
40
20
0
1993 1994 1995 1996 1997 1998 1999*
Hazard Identification and Risk Assessment

60
50
40
30 Mandatory
Suggestion
20
10
0
1993 1994 1995 1996 1997 1998 1999*
Personnel Training
60
50
40
30 Mandatory
Suggestion
20
10
0
1993 1994 1995 1996 1997 1998 1999*
Personal Hygiene/Protection
60
50
40
30 Mandatory
Suggestion
20
10
0
1993 1994 1995 1996 1997 1998 1999*
Facilities, Procedures, and Monitoring

60
50
40
30 Mandatory
Suggestion
20
10
0
1993 1994 1995 1996 1997 1998 1999*
Medical Evaluation/
Preventative Medicine for Personnel
60
50
40
30 Mandatory
Suggestion
20
10
0
1993 1994 1995 1996 1997 1998 1999*
More common deficiencies:

 Hazard identification/risk assessment.
 Personal hygiene/protection.
Less common deficiencies:

 Personnel training.
 Facilities, procedures and monitoring.
 Medical evaluation/preventive medicine.

Animal experimentation involving

hazards
This category reflects how OHSP components are
implemented and coordinated to ensure safety in the
face of a particular hazard.
Animal Experimentation
Involving Hazards
60
50
40
30 Mandatory
Suggestion
20
10
0
1993 1994 1995 1996 1997 1998 1999*
OHSP expectations:
 Individual components that are appropriate
for the facility.
 Evidence that the components work effectively

together.
Section 2
Issues in OHSP
Implementation and Participation
Christian E. Newcomer, V.M.D., DACLAM

Research Professor and Director
Pathology and Laboratory Medicine
The University of North Carolina at Chapel Hill
Issues in OHSP
implementation and participation
OHSP implementation: first steps
 What mandates the creation of an OHSP?

 Who authorizes the OHSP?
 Who funds the OHSP?
 Who designs the OHSP?
 Who coordinates the OHSP?

Issues in OHSP
OHSP implementation issues:

What mandates the creation of an OHSP?
• PHS Policy: “The Guide”
• OSHA: CFR 29
• ILAR: “Occupational Health and Safety

in the Care and Use of Research
Animals”
Issues in OHSP

Who authorizes the OHSP?
The senior official must:

• Understand the issues.
• Provide guidance.
• Establish and support policies.
• Have resource authority.
• Assemble the team.
Issues in OHSP
Who funds the OHSP?

• The Senior Official is accountable.
By what funding mechanism?

• The funding mechanism is not of concern
to the AAALAC peer review process!
Issues in OHSP

 Who designs the OHSP?
 Who or what qualifies the OHSP designers?
 Does one design fit all or are there

various successful models?
 Opportunities for cost containment?

Issues in OHSP
OHSP design team members:

 Animal Care and Use Staff
 Research Staff
 Environmental Health and Safety
 Occupational Health/Medicine
 Administration and Management

Issues in OHSP

 Who coordinates the OHSP?
• Single point coordination of OHSP.
• Team management of OHSP.
• Interaction and communication among team

members to refine approach, measure results and
improve outcomes.
 Are participants clear on the available

OHSP services?
Issues in OHSP
OHSP participation issues:

 What is participation in the OHSP?
 Who participates in the OHSP?
 Can personnel waive OHSP participation?
 How are participants identified/enrolled?
 Who tracks OHSP enrollment?
 What are the enrollment recall provisions?

Issues in OHSP
Issues in OHSP
implementation and participation:
 Who reviews OHSP scope and participation?
• IACUC
• OHSP Coordinator
• Senior Official
• AAALAC International
Section 3
Hazard Control
and Risk Assessment
Ron E. Banks, D.V.M.

University Veterinarian & Director
Office of Laboratory Animal Resources
University of Colorado Health Sciences Center
Hazard control
and risk assessment
What is the principal

objective of an OHSP?
 To reduce to an acceptable level, the risk associated
with using materials or systems that have
inherent danger by controlling or eliminating hazards.
Hazard control
and risk assessment
How does risk assessment

relate to the greater OHSP?
 Risk Assessment is the foundation for progressive OH&S
 Risk Assessment is prerequisite to selecting an appropriate

health-care service for employees!
Hazard control
and risk assessment
What is risk?
 The likelihood of a consequence.

Hazard control
and risk assessment
What is risk assessment?

 A measure of the likelihood of a consequence.
 Defining and quantifying a hazard.

Hazard control
and risk assessment
What ‘issues’ enter into risk assessment?
Known / Work Species Facility

unknown Assignment Engineering
Experimental Duration of Specific Agent Current Health
Conditions Study Properties Status
Outside Work / Frequency of Intensity of Required
Play Exposure Exposure Equipment
Facility History Regulatory Prevalence Personnel
Requirements Experience
Hazard control
and risk assessment
When can I stop defining and quantifying hazards?
 Dynamic process – never completed!

Hazard control
and risk assessment
How important is risk assessment?

 Undetected / undefined hazards pose the
most significant problem to research staff…
 Undetected and unrelated hazards are the

most worrisome.
 You can’t protect staff from the unknown …

Hazard control
and risk assessment
Whose responsibility is it
to identify hazards?
 The researcher
 The facility management team
 The care provider
 In short …. EVERYONE!
Hazard control
and risk assessment
How should risk assessment

be used in the laboratory?
 To manage the hazard
 To avoid / control exposure
 To provide therapy when exposure occurs

Hazard control
and risk assessment
What must you know to perform

risk assessment for chemical agents?
 Toxic doses
 Stability
 Form (gas/liquid/solid)
 Type of toxicity (irrit/corrosion/carcin/narcosis/lethality)
 Severity of reaction
 Mode of action
 Metabolic products
Hazard control
and risk assessment
What must you know to perform risk

assessment for infectious diseases?
 Dose-response relationship
 Virulence
 Communicability
 Prevalence
 Route of exposure
 Shedding patterns
 Stability
 Availability of prophylaxis / therapy
Hazard control
and risk assessment
Does the IACUC have a role

to play in risk assessment?
 Yes!
 Protocol review can (and should) include requests

for information on the potential hazards
of a particular study.
 Hazard review can be performed by:

• A committee member
• A H&S committee or board
• The IACUC
Hazard control
and risk assessment
Where can you find information

to assist in risk assessment?
 Scientific literature
 Other scientists
 MSDS
 The researchers themselves
 Your own staff!
Hazard control
and risk assessment
Risk assessment provides
a touch of reality to life!
 The likelihood of occupationally acquired zoonoses
is MUCH lower than is popularly perceived.
 The likelihood of occupationally acquired immune

response to chemical is MUCH higher than
is popularly perceived.
 ‘Substantial animal contact’ IS NOT a sufficient

indicator of the need for enrollment in OH&SP!
Hazard control
and risk assessment
How can I assure AAALAC site visitors

we have a risk assessment based OHSP?
 OHS ‘Committee’ minutes showing program formation / review.
 Note in semiannual review of OHSP assessment (program review).
 Occasional changes in OHSP process (dynamic process).
 Common sense subtle differences (consistent inconsistencies)

in the OHSP between care facilities.
 A suggestion process involving employees

(program enhancements).
 Ready explanations (consistent between employees) to site visitor

inquiry of why they do something a certain way (PPE / process).
Section 4
Training and
Information Management
Barbara Garibaldi, D.V.M., ACLAM

Director, Animal Research Facility
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Training and
information management
An institution’s approach for providing

education and training depends on its:
 Size
 Resources
 Animal species used
 Research activities
 Staff experience and technical expertise

Training and
Information provided to employees should be

developed through the interaction of several
key people:
 A veterinarian
 A health and safety professional
 A research scientist
Training and
What types of occupational health and

safety training should be provided?
Training and
 The use of personnel protective equipment (PPE).
 Good hygiene practices and universal precautions.
 Laboratory animal allergies.
 Zoonotic agents.
 Ergonomics; Physical Hazards; Noise.
 Training sessions in chemical, radiation, biohazardous

material safety, and bloodborne pathogens may be
provided by experts in the appropriate department.
Training and

 Personnel who have contact with

experimental animals should receive training
in the proper handling of the animals that
they will work with.
 Personnel should be instructed to avoid

unnecessary risk when working with
animals, and to seek expert assistance when
in doubt.
Training and

 Most animal inflicted injuries occur because

of inadequate training and experience, or
because of carelessness.
 Training should be provided that injuries,

splashes, animal bites and/or scratches, and
cuts sustained while working with animals
should be promptly reported and the employee
referred to employee health service.
Training and
What type of documentation

does AAALAC look at?
Training and
 Training logs
 Informational Newsletters
 Written Guidelines
 Websites
Training and
How do you ensure that all individuals

have received OHS training?
Training and
 Utilize human resources (HR) to obtain a list

of graduate students, and new employees.
 Name a designee from each approved protocol responsible

for listing new employees on the protocol and contacting the
IACUC coordinator to set up training.
 This individual can serve as a source of information,

guidance, and instruction for their colleagues.
 Some institutions choose to link training to facility access.

Training and
Approaches to achieving investigator/

scientist participation?
Training and
Occupational health and safety goals and how

they will be achieved must be clearly
communicated to all employees through:
 Formal orientation.
 Distribution of written guidelines.
 And periodic refresher training.

Training and
One option is a mandatory course offered

several times during the year:

 “Live" organized class.
 Distance learning i.e. teleconferencing or video.
 Online training/Web site.
 Individual may be asked to take a test verifying

that the information was understood.
Training and
 Training may be conducted in individual investigator

laboratories, instead of organized classes.
 One-on-one training offered by a veterinarian,

occupational health professional, or designee
(smaller institutions).
 Written guidelines appropriately designed to the scope

of the institution's animal care and use program.
 Brochures/pamphlets.
Training and
What would lead AAALAC to conclude

that training is inadequate?
Training and
Have you been offered participation

in the OHS program?
Training and
 "Details of OHS training program were not provided

to employees and did not include foreseeable hazards such
as exposure to animal allergens."
 "Several procedures described in the occupational health

and safety program (OHSP) brochure, used to train
employees, were not being practiced."
Training and
 “Training provided to researchers using animals consisted

of general print-outs and dated booklets and was not
well-matched to the scope of the program of animal care and
use … a training program covering subjects relevant to the

needs of the institution must be developed and
implemented."
 “The communication of the potential hazards of working

with macaques had been done verbally between the
veterinarian and the investigator but had not been formally
documented."
Training and
How are oversight mechanisms reviewed?

Training and
An effective education and training

program requires:
 Resources
 Administrative record keeping
 A mechanism for monitoring its efficiency
Training and
A wide variety of mechanisms exist for

evaluating the success of the education
and training program.
 Site inspections
 Personnel reviews
 Injury and illness records
 Regulatory-compliance citations
 Periodic questionnaires
Training and
How is information managed?

Training and
Record keeping is essential.

 Training records are necessary to satisfy specific
requirements of federal and state environmental health and
safety regulations.
 Establish a simple system with minimal administrative

burden.
 A computer based system may facilitate such an approach.

Training and
Rapid access to employee-specific

exposure information is vital.
The following documentation should be available:
 Occupational exposures
 Safety training
 Medical surveillance
 Work-related injury and illness
Training and
On-line access to health
and safety information could:
 Improve the management and performance of an occupational health
and safety program.
 Make it practical to develop records that are specific for each research
protocol.
 Computer links with other institutions through external networks, such

as electronic mail, are useful for obtaining current health and safety
information.
 Safety bulletin boards should be available for communicating

with other health professionals.
Training and
Training should be a continuing process

A well-informed staff with safe work habits will:
 Minimize injuries and illnesses

 Reduce costs related to:
• Labor time
• Insurance
• Health care
• And legal actions
Section 5
Medical Evaluation
and Preventative Medicine
Dale G. Martin, D.V.M., Ph.D., ACLAM, ACVPM

Director, Laboratory Animal Science and Welfare
Aventis Pharmaceuticals
Bridgewater, New Jersey
Medical evaluation
and preventative medicine
Martin’s Observation #1:
Physicians should not practice

veterinary medicine.

Martin’s Rule #1:
Veterinarians must not practice

human medicine.
Medical evaluation
The Guide states –

 Input from trained health professionals
 Pre-employment risk assessment
 Periodic medical evaluations
 Appropriate immunizations
 Zoonoses surveillance
 Incident reporting
 Primates (special considerations)
Medical evaluation
Who is the appropriate health professional?

 Occupational health physician
 Occupational health nurse?
 General practitioner?
 Contract nurse?
 Attending veterinarian?
 Senior animal caretaker?
Medical evaluation
What services should be provided?

“The occupational health services are often the most
difficult for an institution to plan or carry out because
consensus on what needs to be done has not yet been
established.”
ILAR, NRC Occupational Health and Safety
in Research Animal Facilities.
Medical evaluation
What services can be provided?

 Pre-employment medical evaluation
 Periodic health evaluations
 Episodic health evaluations
 Analysis of adverse outcomes
 Medical management of worker compensation cases
Medical evaluation
What services can be provided? (continued)

 Immunizations/serum banking
 Hearing conservation program
 Ergonomic program
 Allergy program
 Respiratory protection program
 Reproductive counseling
 Non-human primate exposure program
Medical evaluation
For pre-employment or periodic evaluations,

should it include a questionnaire and/or
a physical?
Ideal- questionnaire + physical
Medical evaluation
What questions should be asked?

 Do you have any allergies?
 Are you allergic to animals?
 What hazards were you/will you be exposed to?
 What animals do you/you work with?
 Have you had illnesses associated with working
with animals (zoonoses)?
 Do you have back problems, etc.?
Medical evaluation
Symptoms of allergy and asthma:
Allergy- Asthma
• Sneezing • Coughing
• Nasal congestion • Wheezing
• Itchy eyes • Chest tightness
• Cough • Shortness of breath
Medical evaluation
Components of one
“allergy” program:
 Screening
 Management of the sensitized patient
 Management of the allergic and/or asthmatic patient
 Management of the anaphylactic patient
Medical evaluation
Components of one “allergy” program:

Screening
 Questionnaire- family/personal history
 Testing
• Skin
• RAST- IgE
• ELISA- IgE
Medical evaluation

 Screening
• Avoid exposure (PPE, procedures)

• Questionnaire (symptom progression)
• Enrollment in respiratory protection program
• Pulmonary function testing
Medical evaluation

 Screening
 Management of the allergic and or asthmatic patient

• Periodic pulmonary function testing
• Emmunotherapy?
 Management of the anaphylactic patient

• Emergency (Epi)
Medical evaluation
What immunizations or screening

programs should be included?
 Tetanus (Guide)
 Rabies?
 Hepatitis B?
 Other immunizations?
 TB testing?
 Serum banking?
Medical evaluation
Should serum banking be a part

of an Occupational Health program?
“Only when there is a clear reason for obtaining the specimens
AND there is a plan to analyze the data as a part of a risk assessment
strategy. …..substantial issues should be considered in advance of
instituting a serum banking program including chain of custody,
confidentiality, identification and handling of samples, retention,
potential deterioration of sample quality over time, and cost.”
ILAR, NRC Occupational Health and Safety

in the Care and Use of Research Animals.
Medical evaluation
Special precautions for primates:

 TB testing
 Herpes B program
• Pre-arrangement with health professionals

• Bite/scratch kits
• SOPs for sampling/testing
Medical evaluation
Martin’s Observation #1:

Physicians should not practice Veterinary Medicine.
Martin’s Rule #1:

Veterinarians must not practice Human Medicine.

Martin’s Advice #1:
Obtain and retain appropriate health professionals to set up
and administer the Medical Evaluation and Preventive
Medicine aspects of your Occupational Health and Safety
program.
Occupational Health
and Safety Programs:
An AAALAC Perspective

Occupational Health and Safety Programs:: An AAALAC Perspective

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Occupational Health

and Safety Programs:

David DeLong, D.V.M.

Why does AAALAC assess

According to the Guide -

Working with animals

 Protocol related hazards

 During the site visit, review facilities

The Guide is the basis for the review.

What are the required

 Personal hygiene and personal

 Facilities, procedures, and monitoring.

 Medical evaluation and preventive medicine.

What are the hallmarks

 Sound implementation strategies.

 Effective coordination of program components.

What trends in OHS Program

Occupational Health and Safety of Personnel

Hazard Identification and Risk Assessment

Facilities, Procedures, and Monitoring

More common deficiencies:

Less common deficiencies:

 Facilities, procedures and monitoring.

 Medical evaluation/preventive medicine.

Animal experimentation involving

 Evidence that the components work effectively

Christian E. Newcomer, V.M.D., DACLAM

OHSP implementation: first steps

 What mandates the creation of an OHSP?

 Who coordinates the OHSP?

OHSP implementation issues:

• PHS Policy: “The Guide”

• ILAR: “Occupational Health and Safety

OHSP implementation issues:

The senior official must:

OHSP implementation issues:

Who funds the OHSP?

By what funding mechanism?

OHSP implementation issues:

 Who or what qualifies the OHSP designers?

 Does one design fit all or are there

 Opportunities for cost containment?

OHSP design team members:

 Environmental Health and Safety

 Administration and Management

OHSP implementation issues:

• Single point coordination of OHSP.

• Team management of OHSP.

• Interaction and communication among team

 Are participants clear on the available

OHSP participation issues:

 Who participates in the OHSP?

 Can personnel waive OHSP participation?

 How are participants identified/enrolled?

 Who tracks OHSP enrollment?

 What are the enrollment recall provisions?

Ron E. Banks, D.V.M.

What is the principal

How does risk assessment

 Risk Assessment is prerequisite to selecting an appropriate

 The likelihood of a consequence.

What is risk assessment?