Susan Silk, MS

Director, Division of Policy and Education

Office of Laboratory Animal Welfare, NIH

2015 PHS Policy

This policy requires that
Assured institutions base
their programs of animal
care and use on the
Guide for the Care and
Use of Laboratory
Animals
The 6th Edition of the
Guide was incorporated
by reference into the PHS
Policy in 1985.
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Policy footnote 2

Self Monitoring, Self Reporting

It is far preferable to place primary responsibility

for assuring compliance with NIH guidelines on
committees within institutions rather than
relying on intrusive Federal inspections.
3

Congressional Committee report

1985 Health Research Extension Act

1985 Guide for the Care and Use

of Laboratory Animals
Proper care and humane
treatment of animals used in
research, testing, and
educationrequire scientific
and professional judgment,
which is based on knowledge
of the husbandry needs of each
species and the special
requirements of research,
testing, and educational
programs.
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Guide, 6th Edition 1985

2011 Guide for the Care and Use

of Laboratory Animals
Performance standard means a standard or guideline that,
while describing a desired outcome, provides flexibility in
achieving this outcome by granting discretion to those
responsible for managing the animal care and use program,
the researcher, and the IACUC.
The performance approach requires professional input, sound
judgment, and a team approach to achieve specific goals...
Performance standards can be advantageous because they
accommodate the consideration of many variables... so that
implementation can be best tailored to meet the
recommendations in the Guide. (See Guide pages 6-7.)
http://grants.nih.gov/grants/olaw/positionstatement_guide.htm#performance
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SCAW Conference 1997

June 1997 SCAW sponsored a conference in Baltimore and began
a new initiative focused on how to translate theoretical performance
standards into practical, easy-to-implement guidelines for the
care and use of many species of research animals.
Performance standards require professional judgment that is
supported by real data, measurements and defined outcomes.
Once performance standards have been defined, then different
applications and methods for assessment of outcomes need to be
developed. This meeting was a starting point to begin looking at
these processes.

Performance Standards and Animal Welfare: Definition, Application and

Assessment Parts I & II 1998 (out of print)
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2007 request to NIH

from ILAR Council Chair
on behalf of ILAR Director
regarding the process of
updating the 7th Edition
(1996) of the Guide.

Council members pointed

out the necessity of

preserving, and perhaps
even increasing, the
performance-based nature
of the document.

2011Guide Statement of Task

Where scientifically warranted, the guidance
and recommendations of the 1996 Guide will be
changed to reflect new scientific evidence,
while maintaining the performance standards
of the 1996 Guide.

Guide Appendix C

NIH Position (1)

Performance standards are the most important
component of the infrastructure of PHS oversight
of animal programs at Assured institutions.
IACUCs are able to meet their responsibility to
ensure humane animal care and use while
advancing quality scientific research through the
use of performance standards in their oversight
of institutional animal programs.
http://grants.nih.gov/grants/olaw/positionstatement_guide.htm#performance

NIH Position (2)

OLAW encourages the cooperative application
of diverse expertise to develop outcome-based
performance standards that enhance the quality
of animal care and use programs.
OLAW expects Assured institutions to apply
appropriate professional judgment and experience
to the challenges inherent in developing policies and
procedures to maintain a quality program that
provides humane care to vertebrate animals.
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NIH Position (3)

Implementation of the Guide is expected to have a
minimal impact on institutions that are currently using
policies and procedures based on well-developed
performance standards. These policies and procedures
may not need to be revised as part of the institution's
implementation of the 8th Edition of the Guide.
Institutions that do not currently have performance
standards that meet the criteria stated in this document
are expected to use the benchmarks provided by the
8th Edition of the Guide to develop performance-based
policies and procedures.
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NIH Performance Standard Criteria

A well-established performance standard
meets the following criteria:

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supports scientific objectives;

supports the health and welfare of the animal;
includes a justified performance index; and
has associated outcome criteria.

NIH Position Statement

OLAW Responds to Concerns Regarding
Adoption of the Guide for the Care and Use
of Laboratory Animals: Eighth Edition
December 2, 2011
May 2012 Update

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Guide Implementation Webinars

NIH Adopts 8th Edition of the Guide: A Discussion
December 8, 2011
Use of Non-Pharmaceutical-Grade Chemicals and Other
Substances in Research with Animals March 1, 2012
Performance Standards April 19, 2012
Housing Laboratory Rodents According to the 8th Edition
of the Guide July 19, 2012

http://grants.nih.gov/grants/olaw/educational_resources.htm
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Can Performance Standards be Used

in Determining Rodent Housing Practices,
Including Management of Rodent Breeding Colonies?
Performance standards are to be applied to rodent housing
issues.
While the Guide's space recommendations are accepted
reference points for addressing space needs, performance
standards allow flexibility to improve animal welfare and
scientific research.
Adjustments to recommendations for primary enclosures may
be made at the institutional level by the IACUC.
OLAW FAQ F10 http://grants.nih.gov/grants/olaw/faqs.htm#674
See also Guide pages 56-58
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OLAW FAQ F10 (2)

The IACUC should critically evaluate objective measures of
outcome-based performance. The Guide identifies
examples of performance indices to assess adequacy of
housing including:
health,
reproduction,
growth,
behavior,
activity, and
use of space.

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OLAW FAQ F10 (3)

Rodent cages of the size commonly used in the US
may be appropriate for pair or trio breeding.
The Guide does not add specific, additional engineering
standards for breeding configurations. This empowers
institutions to determine appropriate housing.
The IACUC must consider relevant factors when assessing
the adequacy of cage space according to performance
standards. Examples of these factors may include:

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OLAW FAQ F10 (4)

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average litter size of the strain(s) of rodents;

whether multiple litters are present in the cage;
difference in the age of the pups of different litters;
growth rate;
need for cross-fostering;
cage dimensions; and
overall management and husbandry practices
such as cage sanitation or bedding change.

OLAW FAQ F10 (5)

Blanket, program-wide departures from the Guide for
reasons of convenience, cost, or other non-animal welfare
considerations are not acceptable.
Cages that might be acceptable when litters are born
may have insufficient space as pups grow.
Whatever parameters are used to establish breeding
configurations and weaning procedures, the IACUC must
ensure that cage population does not negatively impact
animal well-being and overcrowding does not occur.

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May Performance Standards

Determine Housing Issues?
Performance standards are to be applied to housing issues.
Outcome-based performance standards are paramount when
evaluating cage or pen space for housing animals used for
research, research training, and biological testing.
While the Guide's space recommendations are accepted
reference points for addressing space needs performance
standards allow flexibility to improve animal welfare and
scientific research.
OLAW FAQ F16 http://grants.nih.gov/grants/olaw/faqs.htm#3285
See also Guide pages 50 63 and 6 - 7.
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FAQ F16 (2)

An institutions animal housing practices must be speciesspecific, appropriate for the animals, and in compliance with
all applicable federal and local regulatory requirements.
Compliance with the applicable regulations (9 CFR
Subchapter A) issued by the U.S. Department of Agriculture
under the Animal Welfare Act are an absolute requirement of
the PHS Policy Footnote 2, page 9.

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May Performance Standards

Determine Environmental Issues?
An institutions environmental enrichment practices must be
species-specific and appropriate for the animals.
Devices that animals climb on or through, perch on, or nest in
contribute to, rather than detract from, the animals living space
and need not be subtracted from the floor dimensions.
Some species are upset by the introduction of novel items.
Animals should not be subjected to the presence of items that
they find distressing.
OLAW FAQ F17 http://grants.nih.gov/grants/olaw/faqs.htm#3286
See also Guide pages 52 - 54
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FAQ F17 (2)

Compliance with the applicable regulations
(9 CFR Subchapter A) issued by the US
Department of Agriculture under the Animal Welfare
Act are an absolute requirement of the PHS Policy
(Footnote 2, page 9).

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Can Performance Standards be Used

in Determining Rabbit Housing Practices?
OLAW concurs with the Guide that animals should be
housed under conditions that provide sufficient space
to meet physical, physiologic, and behavioral needs.
The height of an enclosure can be important to allow for
expression of species-specific behaviors and postural
adjustments. Cage height should take into account the
animals typical posture and provide adequate clearance
for the animal from cage structures, such as feeders and
water devices.
OLAW FAQ F18 http://grants.nih.gov/grants/olaw/faqs.htm
See also Guide pages 50 51 and 56
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FAQ F18 (2)

IACUCs may consider the use of a rabbit cage that is
14 inches in height, if appropriate for specific animals.
The IACUC should establish, through performance indices
related to animal well-being, that the cage provides sufficient
space to meet the physical, physiologic and behavioral
needs of the animal.
For example, the rabbit must be able to hold its ears
in an upright position (if this is natural for the breed)
and ears must not be forced to fold over by contact
with the cage ceiling.
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