Sharing of Acceptable

Performance Standards
Steven M. Niemi, DVM, DACLAM

Washington, DC
April 21, 2015

For the Record

The opinions in this presentation are mine alone,
and may not reflect those of this venues host,
current or past employers, professional
affiliations, colleagues, family or anyone else I
ever met.
I have no commercial or financial conflicts to
declare. Vendors are named only for example
purposes, and their mention does not imply an
endorsement of any products or services.

Todays Remarks
Why PS sharing is vital (literally)
PS examples and outcomes
A framework for PS sharing

(http://www.phrma.org/sites/default/files/pdf/2014_PhRMA_PROFILE.pdf)

In 1995 constant $ (CPI)

R01-Equivalent grants, New (Type 1)

Success rates, by career stage of investigator

What If?
FY14 NIH RPG & RO1 awards
$25.9B for 14,404 awards (ave $1.8M/yr)

Est. animal care direct expenses ~1.67%

of academic institutional research budget
(~$430M)
Est. 20% of $ wasted on unnecessary
engineering standards and convention
($86M, ~48 additional awards)

Percentage of NIH R01 Equivalent Principal Investigators of All Degrees:

Age 35 and Younger vs. Age 66 and Older
Fiscal Year 1980 - 2014

The Graying of Academic Science

1980

2013

The Graying of Academic Science

What About the Future?

FY14 NIH new investigator awards =
144 @ $250K/yr
Est. animal care direct expenses
~1.67% of total academic institutional
research budget ($430M)
Est. 20% of $ wasted on unnecessary
engineering standards and convention
($86M, ~215 additional awards @ 60%
F&A burden)

Valuing Performance Standards*

Financial relief: $ for science, shareholders
Environmental relief: energy consumption, waste
Compliance relief:

How to Start?
Ask four simple questions:
1. Are we doing things right?
2. If so, what would be even better*?

3. Are we doing the right things?

4. If not, what would be even better*?
* faster, easier, more humane, cheaper, safer, less mistakeprone, etc. (i.e., OK even if animal welfare unchanged)

How to Start?
Ask four simpler questions:
1.
2.
3.
4.

What are we doing thats wasteful?

What are we doing thats dangerous?
What are we doing thats error-prone?
What are we doing thats stupid?

Whats Wrong With This Picture?

Air showers + rodent
microisolator technique?
30 sec/shower x 10
techs x 3X/day x 260
days = $1,500/year in
labor costs

Whats Wrong With This Picture?

PPE + rodent microisolator technique?

or

Before and After

Standardizing the Definition of a

Dirty Soiled Rodent Cage
Julieanne Brandolini B.S., LAT
Stefanie Gentile B.S., LAT
Felisberto Pina
Donna Matthews Jarrell, DVM, DACLAM
Center for Comparative Medicine
Massachusetts General Hospital
Charlestown, MA

American Association for Laboratory Animal Science

60th Annual Meeting, Denver Colorado
PS # 30, November 10, 2009

Implications
30% of cages didnt need changing at
scheduled cycles
(27,000 mouse cages, 85% IVC, 15% static)

Lean: labor by >8,000 hrs (4 FTE)/year

Green: >242K changes/yr avoided/delayed
Serene: Mice disturbed less often

More Animal Care Options

Dont sterilize rodent barrier caging, racks
Sterilize incoming bedding only

Allow 20%RH in rodent barrier rooms

during frigid weather
Primary enclosures stay @ 30%RH

Maintain NHP @ 6 fresh air changes/hr

Routine care for non-toxic toxic cages
ABSL-1 for human cell line xenografts

Vet Med, Compliance Options

Replace sentinel rodents with PCR swabs
of inanimate surfaces
IVC exhaust plenums, etc., exptl animals

Eliminate annual review of non-USDA,

non-DOD protocols
Eliminate de novo triennial rewrite and
review of USDA protocols not PHSfunded

How To Share & Promote PS?

- PS must be evidence-based
- Local IACUC approval where appropriate

- Trial M&M, results must be available

- Peer-reviewed publication not necessary

- Need MANY examples in 1 public

repository of locally adopted examples
- No guarantee of applicability or external
(compliance, accreditation) acceptability

Whats Lacking: Courage

Suggested Repository Features

Reliable, secure host and server

User-friendly website, searchable content
Entries by category, other, or not at all?
Entries linked to pertinent section(s) of
the Guide, AWA, other
Share local allowances by USDA inspectors

Password-restricted access?
Invite suggestions from the public?

Repository Management
1st filter only to avoid nonsense, screeds
2nd filter of rotating panel of peers only to
identify obvious content gaps or errors
Beyond that, everythings acceptable
Recruit responsible animal protectionists as
panelists

Invite commentary and annotations

(similarly twice filtered)

Yes, Thats Right

Repository Launch
Logical host: ILAR Roundtable (= ROI)
Funding: dues, subscriptions, donations, grants
If not ILAR RT, then another NGO?

Target timeframe: ASAP

Sharing of Acceptable
Performance Standards
Steven M. Niemi, DVM, DACLAM

Washington, DC
April 21, 2015