Spring 2003 Connection

16 Pages·2003·22.26 MB·English

5 Newly 12 Potential impact of
accredited proposed changes
CCoonnnneeccttiioonn
institutions to ETS 123 AAALAC I
NTERNATIONAL
5 Bayne elected 15 AAALAC receives
VP of ACLAM Cohen Award
6 Who’s responsible 16 Register online
for offsite for the AAALAC
animals? Conference!
Spring 2003 A newsletter for people working with animals in science.
Association for Assessment and Accreditation
of Laboratory Animal Care International
Overcoming the challenges of
Animal transportation
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of commercial airlines willing to carry animals, changing
regulations, and different import and quarantine laws
for each individual country make transporting animals a
time consuming—and expensive—aspect of biomedical
research. This article will discuss some of the current
issues and concerns surrounding animal transportation,
and offer some suggestions for facilitating effective
operations and assuring good animal care.
Welfare, reluctance, and regulations
There are several major issues surrounding animal
transportation. Of overarching concern is the welfare of
the animals during transport. Once animals are turned
over to an airline or ground carrier, control is relinquished
to the carrier and the shipper must rely on a third party to
make sure the animals receive proper care. found better met through the establishment of a dedicated
Though it’s not done intentionally, there are many ground delivery system,” Matthews adds.
examples of animals being poorly treated while under the Nonhuman primates pose additional challenges. “Of
control of carriers. Instances of animals sitting for hours the few commercial airlines that will still carry nonhuman
on runways in airplane cargo holds; animals being lost or primates, most will take only two to four animals at a
misrouted; animals exposed to temperature extremes; or time,” says Christian R. Abee, D.V.M., M.S., Professor and
careless, unnecessary accidents, still occur. Chair of the Department of Comparative Medicine at the
The second issue is the growing reluctance among University of South Alabama’s College of Medicine, and
airlines to transport animals. member of AAALAC’s Council on Accreditation. “So if we
“A year ago, 40 to 50 percent of our shipments were by have a lot of animals, we may need to schedule four or fi ve
air. Now it’s down to 7 to 9 percent,” says Laura Matthews, separate fl ights, or we wind up hiring a charter jet to get
Transportation Manager for The Jackson Laboratory. She them into the country, which is very expensive.”
notes that a large part of the drop is due to the reduced The third, and perhaps most challenging, issue is the fact
number of airlines willing to carry animals on a consistent that every country has its own set of regulations regarding
basis. “Providing consistent service to the customer and the import and export of live animals. Not only do these
optimum conditions for the animals is a necessity that we regulations change, but there is no central information
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resource—no one authority—that is an international agreement between governments
can provide current, live animal to ensure that international trade in wild animals and
shipping requirements for every plants does not threaten their survival. In the U.S., the
country and every regulating Fish and Wildlife Services is the CITES management
organization. authority. (www.cites.org)
Combined, these issues
make transporting animals an • U.S. Customs. Visit www.customs.gov for U.S. import
extremely diffi cult process to and export information.
navigate. But despite these
challenges, it is possible to • Customs laws of the receiving country. Check the
facilitate smooth animal shipments by paying attention to trade laws for each individual country for details.
a few key areas …
• International Air Transport Association (IATA).
The “IATA Live Animals Regulations” set the standard
Understand the regulations and
for transporting live animals by commercial airlines.
provide proper documentation
The publication is considered by many to be an
essential reference for professionals in the business of
When you ship animals to another institution, particularly
shipping live animals. (www.iata.org)
if the institution is located outside the United States, you
may need to comply with regulations and guidelines from
• Animal Transportation Association (AATA).
a half dozen different organizations.
Publishes the “2nd Manual for the Transport of Live
“There is not a single reference point to go to in order
Animals.” (www.aata-animaltransport.org)
to fi nd out what you need to do to ship your animals
nationally or internationally,” says Hilton J. Klein, M.S.,
• Offi ce International des Epizooties (World
V.M.D., Senior Director of Comparative Medicine for
Organization for Animal Health). Works to guarantee
Merck Research Laboratories, and former president of
the transparency of animal disease status worldwide
AAALAC’s Council on Accreditation.
and the sanitary safety of world trade by developing
This makes it critical for someone on staff to become
sanitary rules for international trade in animals and
familiar with the regulatory and oversight organizations,
animal products. OIE standards are recognized by the
and to know where to turn for information about the latest
World Trade Organization. (www.oie.int)
requirements.
Be sure to know the applicable rules regarding
Key organizations include:
quarantine for your shipment, particularly for nonhuman
primates. The CDC and APHIS can provide specifi c
• USDA, Animal and Plant Health Inspection
information on this.
Service, Animal Care. This component of USDA
enforces the Animal Welfare Regulations which include
many requirements for transporting animals.
Designate a point person
(www.aphis.usda.gov/ac/)
Designating a person to be in charge of remaining current
• USDA, Veterinary Services. This division works to on transportation regulations will help ensure compliance.
prevent the introduction of dangerous and costly pests “International regulations are shaped by the country
and disease. They provide information on importing you are shipping to, and the regulations are frequently
and exporting animals. (www.aphis.usda.gov/vs/ncie/) in a state of fl ux,” says Klein. “In order to be effective in
transporting animals, we make sure we have someone
• Centers for Disease Control and Prevention who knows the rules, regulations, and the key people
(CDC). Their Division of Global Migration and at those organizations. It’s not enough to learn this
Quarantine includes information on the importation of information one time—because the next time you ship,
animals into the United States. lots of things may have changed.”
(www.cdc.gov/ncidod/dq/animal.htm) Once you understand the regulations and requirements,
make sure that all necessary forms and related
• U.S. Fish and Wildlife Service (FWS). The FWS documentation are properly completed.
oversees regulations and permits regarding the import Tom Schooler, President of Animal Port Houston (a live
and export of native endangered and threatened animal freight forwarding company) and board member
species. (www.fws.gov) of the Animal Transportation Association (AATA), offers
several paperwork tips ...
• Convention on International Trade in Endangered “First, make sure that all original documents accompany
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AAALAC Connection AAALAC Connection
2 3
the animals. Hand sign all documents—not doing so Goldentyer, D.V.M., USDA’s
can hold up your shipment. Remember that the health Eastern Regional Director.
certifi cate is an offi cial international document, and the “Sometimes people simply don’t
original should accompany the animals,” Schooler says. think through the transportation
process.”
Use quality shipping containers
Communicate clearly
Schooler notes that a great deal of care should be taken to
and often
obtain proper shipping containers.
Matthews suggests starting with a good, hard, rigid Goldentyer reports that one of
shipping container. “Something that won’t get damaged or the biggest problems seen by APHIS is the misrouting of
become soggy if it gets wet.” animals. When this happens, the animals are sometimes
After you fi nd good containers, mark the outside clearly. stranded and may not get fed. Staying in contact with
There are accounts of containers being shrink-wrapped on all parties involved along the way can help avoid these
airport cargo docks because they were not marked “Live situations, and help ensure a smoother trip for the
Animals.” Make sure there can be no doubt about the animals.
contents of the containers. “It seems like a lot of problems occur between the
If you don’t own good containers, there are a number time the animals reach the destination airport and when
of companies that build custom transport crates. These they are delivered to the facility,” Matthews notes. To
containers are made to your specifi cations and also meet prevent these problems, representatives at the receiving
USDA, IATA and AATA standards and requirements. airport need to be given clear instructions on handling
Recommendations by colleagues, the AALAS list of the animals. “Some of our customers choose to be at the
vendors (visit www.aalas.org and click on “vendors”), and airport and pick up the animals themselves—they feel
the USDA’s list of registered handlers (see “Resources” more comfortable doing this,” Matthews says.
on page 4) are good places to begin searching for Abee reports that sometimes shippers will inadvertently
companies. An internet search on “custom built animal expose the animals to contaminants by putting them in
transport crates” will also produce a list of possible a room with other species or by getting the fi lter paper
vendors. on the containers wet. Good communication and a bit of
education can help prevent shipping company personnel
from endangering the animals or compromising their
Monitor enclosures
health.
and ambient conditions
Using high-quality shipping containers will go a long
Decide how you will
way in making sure the animals’ primary enclosure
manage the process
environment is comfortable. Adequate food and hydration
sources must be provided—enough to account for the trip When you’re getting ready to transport animals, there are
plus any possible delays. “It also helps to provide a good, three basic ways to manage the process …
absorbent bedding for the animals,” Matthews says.
Be mindful of food products that could pose a customs
Do it yourself
problem. For example, some fruits or vegetables might
not be permitted into some countries. The same holds As noted earlier, handling the transportation in-house is
true for other materials that might be found in or on best accomplished by designating one person who will
animal crates, such as pieces of bark. be responsible for understanding and remaining current
Just as important are the ambient conditions at the on the regulations and guidelines. The next step is to fi nd
time of shipping. Excessive heat and cold are the biggest reliable and knowledgeable outside partners.
threats to animal health. “You need to create a network of reputable people
“Pay attention to the weather,” says Abee. “If it’s you can trust, and designate one person to oversee the
summer, you want to ship during the coolest part of the process,” Klein says.
day, or perhaps at night.” Abee adds, “We’ve developed really good relationships
“Summer and winter are the most challenging times with our local shipping people and we work closely with
to ship,” says Matthews. “In the summer, between the them in a good spirit of cooperation.”
body heat generated by the animals and the outside Also recognize that when so many partners and
temperature, the animals can be greatly affected if their variables are involved, even the best laid plans can go
microenvironment isn’t properly controlled. The fewer awry. The key is to be prepared for emergency situations.
legs you have on the trip, the better.” “It’s imperative to have an emergency plan in place before
“You need to be aware of each stop along the way and the animals are shipped,” Klein says. “The last thing you
the conditions the animals could encounter,” adds Betty
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want is for animals to be held up get together to give careful, thoughtful consideration
in customs and no one available before implementing more regulations.”
who knows what to do.” The new Homeland Security Act may also impact the
transport of animals. Schooler notes that in light of the
new department, “We need to be ready for the rules to
Work with
an outside specialist change all the time.”
In the meantime, you can get your animals where
The second way to manage the
they need to go, safely and comfortably, through good
process is to get assistance from
management, effective communication, and by developing
an outside company. For a fee,
your own network of reliable vendors who understand
intermediate handlers, like Schooler’s company, can
what it takes to ensure animal well-being during
coordinate your shipments.
transport. §
“Most of our time is spent collecting information for our
customers—the documentation they need for a particular
country, specifi cs on shipping containers and markings,
and proper notifi cations and permits,” Schooler says.
Resources
Abee notes that his organization uses this type of
broker, particularly on the other end of international
· AATA 2nd Manual for the Transport of
shipments. “That way, they can help us make sure we’re
Live Animals, published by the Animal
meeting that country’s regulations,” Abee adds.
Transportation Association,
Talking to colleagues is the best way to fi nd a reliable
www.aata-animaltransport.org
broker. A list of intermediate handlers who are registered
with the USDA is also available at www.aphis.usda.gov/
ac/lists/listh.pdf. · Animal Welfare Regulations,
www.aphis.usda.gov/ac/
Use the other party’s shipping services
· Centers for Disease Control
If available, this is often the easiest and most reliable and Prevention (CDC),
choice since these companies are set up to handle and www.cdc.gov/ncidod/dq/animal.htm
track all of the details. Most large animal breeding
companies such as Charles River Laboratories, Inc.,
· Convention on International Trade in
Harlan, Taconic and the Jackson Laboratory operate their
Endangered Species of Wild Fauna and Flora
own climate-controlled fl eet of trucks and will handle the
(CITES), www.cites.org
shipping for you.
· International Air Transport Association, IATA
What the future holds …
Live Animal Regulations, www.iata.org
Ground transportation (when possible) is likely to
become the most popular option, not only because it’s · Offi ce of International des Epizooties,
more accessible than air travel, but also because it tends www.oie.int
to allow a greater level of control. As noted above, many
of the large breeding companies have purchased their
· U.S. Customs, www.customs.gov
own fl eet of dedicated trucks for this reason—to control
the transport of their animals to customers. There are
also a number of private companies, such as Animal Port · USDA APHIS’ list of registered animal
Houston, Frames Animal Transportation Service, O’Brien carriers, www.aphis.usda.gov/ac/lists/listt.pdf
Animal Transportation and Services, and TransporTech,
that have climate controlled trucks specifi cally for
· USDA APHIS’ list of registered intermediate
domestic transport.
handlers, www.aphis.usda.gov/ac/lists/
The complexity and fl uidity of the regulations is likely
listh.pdf
to prompt increased use of third-party brokers, or
intermediate handlers, to help manage the process. But
· U.S. Fish and Wildlife Service, www.fws.gov
exactly how the regulations will change in the months and
years ahead is unknown.
“I can’t predict the future, but I’m sure transporting · USDA Veterinary Services,
animals is not going to get any easier,” Abee says. “If it www.aphis.usda.gov/vs/ncie/
becomes any more diffi cult, I’m afraid it’s really going to
hurt biomedical research. I would hope countries would
AAALAC Connection AAALAC Connection
4 5
Congratulations to the institutions
that earned accreditation in 2002 ...
• Ace Animals, Boyertown, Pennsylvania • New York Medical College, *
All eight
Valhalla, New York
• Alamogordo Primate Facility, National Institutes Ivy League
of Health, Holloman Air Force Base, New Mexico • Norwegian School schools are
o f Veterinary Science,
• Animal Pharm Services, Inc., Healdsburg, California AAALAC
O slo, Norway
accredited!
• Centocor, Inc., Johnson & Johnson, Malvern,
• Princeton University,*
Pennsylvania
P rinceton, New Jersey
• Chiron Corporation, Emeryville, California
• Purdue Pharma L.P.
• College of Veterinary Medicine, Ardsley, New York
The University of Georgia, Athens, Georgia
• R.J. Reynolds Tobacco Company
• Florida State University, Tallahassee, Florida Winston-Salem, North Carolina
• Genetic Advancement Center • Roswell Park Cancer Institute, Buffalo, New York
Trans Ova Genetics, Hull, Iowa
• Stowers Institute for Medical Research,
• Lampire Biological Laboratories, Everett, K ansas City, Missouri
Pennsylvania
• Theravance, Inc., South San Francisco, California
• Magee-Womens Research Institute
• The University of Chicago, Chicago, Illinois
Pittsburgh, Pennsylvania
• Malcolm Randall VA Medical Center
G ainesville, Florida
Kathryn Bayne elected vice president of ACLAM
KKKKKaatthhrryynn AA.. BBaayynnee,, MM..SS..,, Institutes of Health Small Business Innovation Research
PPhh..DD..,, DD..VV..MM..,, AAAAAALLAACC’’ss (SBIR), and is a member of the American Association
Associate Director, was elected for the Advancement of Science Scientifi c Freedom &
vice president of the American Responsibility Award Selection Panel. Dr. Bayne is past
College of Laboratory Animal president of the Association of Primate Veterinarians and
Medicine (ACLAM). This the DCVMA, and past Vice President of the Scientists
position becomes president- Center for Animal Welfare’s Board of Directors. She has
elect then president over the served on the boards of the National Association for
next three years. ACLAM is Biomedical Research, the American College of Laboratory
a specialty board recognized Animal Medicine (ACLAM), ASLAP and the Lab Animal
by the American Veterinary magazine editorial board. Dr. Bayne served as a member
Medical Association. of the National Academy of Sciences (NAS) committee
Membership currently includes which developed the 7th edition of the Guide for the Care
663 active ACLAM Diplomates. and Use of Laboratory Animals (1996), and the National
Dr. Bayne’s experience with laboratory animal issues is Academy of Science committee that prepared the 1998
extensive. Prior to her position with AAALAC, she worked report, Psychological Well-Being of Nonhuman Primates.
at the National Institutes of Health leading a research During her tenure in the Public Health Service
program on nonhuman primate psychological well-being Commissioned Corps, Dr. Bayne, was the recipient of
and environmental enrichment programs for primates, several awards. In 1993 she received the Henry and Lois
dogs, cats and swine. She has published over forty Foster Award for high score on the practical portion of the
scientifi c articles and is a certifi ed animal behaviorist. ACLAM certifying examination and in 1998 she received
Dr. Bayne currently serves as a member of the AALAS’s Joseph J. Garvey award for work related to
American Veterinary Medical Association Animal Welfare the humane treatment of animals used in biomedical
Committee. She is a reviewer for the Biobehavioral and research. §
Behavioral Processes Study Section of the National
AAALAC Connection AAALAC Connection
6 7
Who’s
Who’s the owner and
responsible who’s responsible?
““TThheerree aarree mmaannyy cchhaalllleennggeess iinn tthhiiss aarreeaa bbeeccaauussee
for Offsite Animals? tthheerree aarree ssoo mmaannyy ggrraayy aarreeaass rreeggaarrddiinngg
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ooff rreesseeaarrcchh ffaacciilliittiieess.. TThhee eexxpplloossiioonn iinn tthhee uussee ooff aannootthheerr iinnssttiittuuttiioonn.. OOrr iinn tthhee ccaassee ooff ccoonnttrraacctt
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nnaattiioonnaall ccoorrppoorraattiioonnss)),, aanndd tthhee rraappiidd ppaaccee ooff rreesseeaarrcchh,, aanniimmaallss aanndd wwhhoo iiss rreessppoonnssiibbllee ffoorr oovveerrssiigghhtt aanndd
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wwiillll ccoonnttiinnuuee ttoo eessccaallaattee aatt aann eevveenn ffaasstteerr rraattee.. ssppoonnssoorriinngg iinnssttiittuuttiioonn ttoo oowwnn tthhee aanniimmaallss.. IInn ootthheerr ccaasseess,,
In many cases, keeping animals offsite offers scientifi c the parent institution requires the offsite organization to
and logistical advantages. But it has also posed some own the animals.
perplexing issues for institutions. Who actually owns these Gerrity notes that issues of ownership and responsibility
offsite animals? Who is ultimately responsible for their may be especially challenging when dealing with
well-being? And if the offsite animals are housed at an primates. For example, if the original owner of a primate
institution that is nnnooottt aaccccrreeddiitteedd bbyy AAAAAALLAACC IInntteerrnnaattiioonnaall,, is conducting a long-term study and doesn’t need the
are there implications for the accredited program? animal for a while, it may loan the animal to another
institution to be held, or perhaps used for blood draws or
other minor procedures. For a number of reasons—e.g.
What’s at stake?
applying the 3 Rs and the scarcity of some nonhuman
primate species—the original institution may wish
Collaboration among institutions—and sharing animals
to retain ownership. The responsibility for decisions
in the process—improves science. It also helps reduce
regarding the health and welfare of the animal on a day-to-
the overall number of animals used. But this type of
day basis should be determined.
collaboration may also make oversight more diffi cult—
Indeed, in any partnership or contract situation, the
especially for institutions that haven’t considered their
issue of who owns the animals—and who will provide
oversight role or other involvement with animals at
oversight and care—should be clearly defi ned and agreed
remote locations.
upon in advance. But there are a number of ways to do
“Today everybody is sharing animals,” says Dennis M.
this and many variables that will affect fi nal decisions.
Stark, D.V.M., Ph.D., Executive Director of Veterinary
Sciences for Bristol-Myers Squibb and an AAALAC
Council member. “This is not just an industry issue, it’s an Ownership and
issue everywhere, including academia.”
proprietary rights to the data
“This is an issue that’s going to get more challenging
as more and more animals are being shuffl ed back and In addition to issues of ownership and responsibility, some
forth,” says Lauretta W. Gerrity, D.V.M., Director of institutions—pharmaceutical companies in particular—
Animal Resources Program at the University of Alabama- are working through possible legal issues surrounding
Birmingham & VAMC, a former member of AAALAC’s animal ownership. Some lawyers representing these
Council on Accreditation who is now an ad hoc Consultant companies feel strongly that animals transferred to non-
to AAALAC. “The question is, ‘who’s in charge of those company (or “host”) facilities must remain the property
animals when they are at each of those places?’” of the parent company. They also want the animals to be
labeled with the company’s name while residing at the
host facility. They believe these measures will help protect
future patent rights.
AAALAC Connection AAALAC Connection
6 7
Stark explains that while pharmaceutical companies The USDA perspective:
are eager to have research generated at collaborating responsibility follows ownership
institutions, legally owning the animals is risky. He
says such agreements between his own institution and According to the USDA, in most cases responsibility for
collaborating institutions are covered by a ‘materials offsite animals is assigned to the institution that owns the
transfer agreement’ that all parties sign. It defi nes who animals. But if more than one facility is involved with a
owns the animals, what standards of IACUC review are particular research study, USDA places responsibility for
expected, what husbandry and veterinary care will be the animals being used not only with the institution that
maintained, and how the animals will be identifi ed. is involved in their housing and care, but also with any
“Some legal opinions note that in order to retain institution that is involved in the planning and execution
proprietary rights to data involving transferred animals, of the study itself.
the source institution must retain ownership of the If an institution merely owns the animals being used
animals,” Stark says. “But some of us in the veterinary in a study—but has no input or is not involved in the
community feel the institution sponsoring the study planning, review, approval, or conduct of the study—then
should be able to retain ownership of the proprietary USDA would not hold that institution responsible for
information generated from the animals, even if the offsite those animals. (In fact, if that was the only involvement
facility assumes ownership of the animals. The partner with animals this institution had, it would not even be
facility should be willing to take on the responsibility of required to be registered since it does not meet the
providing care and doing it right.” regulatory defi nition of a research facility.) If the owning
But while some legal departments are saying they want institution has any say in how those animals were to
to own the offsite animals, others are saying they wouldn’t be used, however, the USDA would then hold them
own them under any circumstances. responsible. USDA representatives say the organization
Stark informally polled his colleagues—industry has encountered this type of situation several times in
veterinarians, most of whom work for pharmaceutical recent years, primarily with regard to transgenic animals.
companies—on the subject. Among those who responded, “It’s important to note that to the USDA, ownership
the majority indicated that their company would nnnooottt oowwnn encompasses more than just ‘sign on the dotted line’
animals held at other institutions or contract research ownership,” Gerrity says. “They also want to know who
organizations. Stark notes that if he had polled the is in cccooonnntttrrrooolll ooff tthhee aanniimmaallss..”” SShhee aaddddss tthhaatt iinn mmaakkiinngg tthhiiss
company lawyers instead of the veterinarians, he may determination, USDA will look at considerations such
have gotten a different response. as: Who wrote the protocol? Whose IACUC is doing the
“The veterinary community is pushing for legal review? Who is conducting the hands-on procedures?
departments to not require that the parent company Who houses the animals? And who provides the daily
maintain ownership,” Bayne observes. But she notes that care?
many lawyers continue to feel that their patent rights may Some believe that the USDA is starting to take a closer
be threatened if they cede ownership to the offsite or look at animals in offsite facilities.
contract facilities. “A lot of these feelings are likely due “I think over the last three or four years we’ve seen
to the complexities of international intellectual property more USDA inspectors paying increased attention to
laws,” Bayne adds. aanniimmaallss aatt ccoonnttrraacctt ffaacciilliittiieess,,”” nnootteess JJaammeess FF.. TTaayylloorr,,
For the foreseeable future, negotiations on this D.V.M., M.S., Director of the Offi ce of Animal Care
topic between the animal care community and legal and Use at the National Institutes of Health (NIH), and
departments are likely to continue. member of AAALAC’s Council on Accreditation. This
means that institutions will need to make sure that offsite
facilities using regulated animals (animals other than rats,
Complying with rules and guidelines
mice and birds) are registered with the USDA if they are
located in the United States. And the parent institution
Whether your institution owns the animals at the host
needs to be able to clearly document ownership and who
facility or not, your institution will, in most cases, be
is responsible for monitoring their care.
subject to certain rules or guidelines. Which rules or
guidelines apply depends on the organizations to which continued next page ...
you are accountable—the USDA, AAALAC International,
OLAW (the Offi ce of Laboratory Animal Welfare), plus
state and local regulations.
“A lot of times, when people get into trouble it’s when
the institutions don’t understand the rules,” says Gerrity.
“It’s not a case of people disregarding them.”
Each of the three organizations—USDA, AAALAC
International and OLAW—have slightly different views on
the issue of offsite animals …
AAALAC Connection AAALAC Connection
8 9
If the offsite facility is also accredited …
Ownership and “The fi rst scenario is that the parent institution—
institution A—has arranged to have research using
AAALAC’s perspective
animals conducted at institution B, and B is also
LLiikkee UUSSDDAA,, AAAAAALLAACC accredited by AAALAC,” Bayne says. “This is an easier
IInntteerrnnaattiioonnaall ffoolllloowwss oowwnneerrsshhiipp scenario to handle.”
iinn tteerrmmss ooff ddeefifi nniinngg wwhhoo iiss During the site visit of the parent institution, the
responsible for animals at an offsite AAALAC evaluators will nnnooottt vviissiitt iinnssttiittuuttiioonn BB,, bbeeccaauussee
facility. If an accredited institution B is already on its own AAALAC site visit schedule.
does not own the animals—if they just own the data that “However, this does not mean that institution A should
results from the studies conducted using those animals— abdicate all responsibility for those animals,” Bayne adds.
AAALAC does not require oversight by the accredited “We would still expect some level of involvement by
program. However, they should ensure that they are institution A’s IACUC.”
partnering with reputable organizations. Although there is nothing in writing and no regulations
Bayne says AAALAC site visitors typically see two that require it, AAALAC generally recommends that
scenarios ... institution A get copies of institution B’s IACUC meeting
minutes and semiannual reviews as they relate to A’s
animals.
“Institution B may want to keep a lot of information
AAALAC’s Rules of Accreditation private, but A certainly has a right to see information that
pertains to its own animals,” says Bayne.
regarding contract facilities
In sum, if AAALAC is site visiting institution A, and
offsite facility B is also AAALAC accredited, AAALAC will
“Institutions may have contractual
nnnooottt vviissiitt BB dduurriinngg AA’’ss ssiittee vviissiitt.. BBuutt,, AAAAAALLAACC wwiillll eexxppeecctt
arrangements for certain aspects of their
A’s IACUC to maintain awareness of—and appropriate
animal care activities with other animal care
involvement in—the work being done on the animals it
agencies/facilities. In some situations, an
owns.
accreditable unit may issue a comprehensive
contract whereby the contractor provides
If the offsite facility is not accredited …
most or all specifi ed facilities, services,
personnel, animals, etc., and the animals are From AAALAC’s perspective, the alternative scenario—
owned by the contractor. In this situation, when the satellite facility is not AAALAC accredited—is
AAALAC International accreditation does not more diffi cult.
extend to the contracted facilities and their “When institution A owns the animals, and offsite facility
associated animal care programs. However, B is nnnooottt aaccccrreeddiitteedd,, AA mmuusstt ddeessccrriibbee BB’’ss aanniimmaall ccaarree aanndd
the accredited unit may have a more limited use program and facilities in its own AAALAC Program
contract in which the accredited unit owns Description and annual report,” Bayne says. “In this
the animals. In this latter situation, AAALAC situation, institution B wwwiiillllll bbee iinncclluuddeedd iinn tthhee ssiittee vviissiitt——
International considers those facilities to be specifi cally, those areas that are related to the animals
an integral part of the institution’s animal owned by A. This includes all housing, support and
care program. The services and facilities procedure areas.” Even if B is geographically far away,
provided by the contractual arrangement AAALAC will evaluate it as part of A’s site-visit process.
must be included in the application and annual But what level of oversight does AAALAC expect the
reports, and the facilities will be visited as a parent institution’s IACUC to have over the animals it
part of the institution’s original and periodic owns at another institution?
site visits to determine compliance with “When the contract or offsite facility is not accredited,
AAALAC International standards. Contractual we suggest that the parent institution ramp up the
agreements made by AAALAC International intensity of its oversight,” Bayne says. She notes that
accredited institutions or applicants must AAALAC typically recommends that this oversight include
provide for the inspection of the contracted a facility inspection as part of the IACUC’s semiannual
facilities by AAALAC International site visit review, along with other forms of long-distance
teams. If the contract facility is separately monitoring.
accredited by AAALAC International and “There’s a risk in partnering with non-accredited
is currently fully accredited, it will not be facilities,” Bayne adds. “The parent institution may be
necessary to visit that facility during the site jeopardized because they are linked with that offsite
visit.” facility. If something happens at the offsite facility—even
if it involves animals not owned by the parent institution,
AAALAC Connection AAALAC Connection
8 9
and even if the report is not factual—the negative public
perception can spill over to the parent institution.”
This is likely the reason why some institutions, the
NIH Intramural Research Program for example, will only PHS Policy on satellite facilities
contract with other AAALAC-accredited institutions.
“We have many animals placed at other institutions—
PHS defi nes a
and the other institutions are all accredited,” says Taylor.
satellite facility this way …
“We will only partner with accredited programs—this is
one of our own ground rules.” “Animal Facility: Any and all buildings, rooms,
He adds that his offi ce dddoooeeesss nnnooottt eexxppeecctt tthheeiirr aanniimmaall areas, enclosures, or vehicles, including satellite
care and use committees to do site visits of those satellite facilities, used for animal confi nement, transport,
facilities. “They may choose to do it, but we haven’t maintenance, breeding, or experiments inclusive
made it a policy that they must,” Taylor says. “We do say, of surgical manipulation. A satellite facility is any
however, that they need to have some form of oversight— containment outside of a core facility or centrally
whether it’s handled by the veterinarian or the project designated or managed area in which animals
offi cer—there needs to be someone who can verify that are housed for more than 24 hours. “
our expectations are being met. But we leave it to the
committees to decide how they will do this.”
It also says that a function of the
AAALAC’s own Rules of Accreditation offer some IACUC is to inspect satellite facilities …
guidelines (see the sidebar on page 8 for details).
“Functions of the Institutional Animal Care and
Use Committee:
Follow the funding:
As an agent of the institution, the IACUC shall
OLAW’s perspective
with respect to PHS-conducted or supported
OLAW, the Offi ce of Laboratory Animal Welfare, has activities:
oversight responsibility for all PHS-funded activities
1. review at least once every six months the
involving animals. Its jurisdiction is based on the source
institution’s program for humane care and
of support, not ownership. Dr. Nelson Garnett, Director
use of animals, using the Guide as a basis for
of OLAW, emphasizes that, “It’s imperative that PHS-
evaluation;
supported institutions that subcontract, collaborate or
have other such agreements with other institutions, 2. inspect at least once every six months all of
clearly defi ne respective responsibilities.” The PHS the institution’s animal facilities (including
Policy requires that all awardees and performance sites satellite facilities) using the Guide as a basis
hold an approved Animal Welfare Assurance.* When an for evaluation …”
awardee institution does not have an Assurance (and
cannot obtain one because it does not have an animal PHS Policy is applied to
care and use program or an IACUC), OLAW negotiates satellite facilities in this way …
an Interinstitutional Agreement Assurance of Compliance
“This Policy is applicable to all PHS-conducted or
whereby the awardee institution will rely on the program
supported activities involving animals, whether
of an Assured institution.
the activities are performed at a PHS agency,
Assured institutions that wish to subcontract or use
an awardee institution, or any other institution
performance sites that are not Assured also have the
and conducted in the United States, the
option to amend their Assurance to cover the nonassured
Commonwealth of Puerto Rico, or any territory
entity. This effectively subjugates the performance site to
or possession of the United States. Institutions
the Assured institution and makes the Assured institution
in foreign countries receiving PHS support for
responsible for the performance site. Garnett adds, “the
activities involving animals shall comply with
Assured institution must then treat the performance site
this Policy, or provide evidence to the PHS
as though it were another component of the institution’s
that acceptable standards for the humane care
program, with responsibility for occupational health,
and use of the animals in PHS-conducted or
training, IACUC review, semiannual inspections, and the
supported activities will be met. No PHS support
reporting and other requirements of the PHS Policy.”
for an activity involving animals will be provided
(OLAW guidance on this is found in NIH Guide notice
to an individual unless that individual is affi liated
OD-01-017.)
continued next page ... with or sponsored by an institution which can
and does assume responsibility for compliance
*Public Health Service (PHS) states that as a condition of receipt
with this Policy, unless the individual makes
of support for research involving laboratory animals, awardee
other arrangements with the PHS. …”
institutions must provide a written Animal Welfare Assurance
of Compliance (Assurance) to OLAW describing the means they
will employ to comply with the PHS Policy.
AAALAC Connection AAALAC Connection
10 11
on what they will track and when. Gerrity sometimes uses
““OOLLAAWW ssaayyss tthhaatt tthhee aawwaarrddeeee what she calls an “off-the-shelf” test to determine the level
iinnssttiittuuttiioonn hhaass rreessppoonnssiibbiilliittyy ffoorr of oversight needed. If her university has an investigator
eennssuurriinngg tthhaatt aallll tteerrmmss aanndd using antibodies produced at a contract lab, she asks if
ccoonnddiittiioonnss ooff aawwaarrdd,, iinncclluuddiinngg tthhee those antibodies are being produced specifi cally for that
PPHHSS aanniimmaall wweellffaarree ppoolliiccyy,, aarree study. If they are, the institution will assume responsibility
mmeett..”” GGeerrrriittyy ssaayyss.. HHeerr for overseeing the animals involved in the production of
iinnssttiittuuttiioonn hhaass iinnvveessttiiggaattoorrss iinn the antibodies. But if those antibodies would be produced
ootthheerr ccoouunnttrriieess aanndd aatt ootthheerr UU..SS.. anyway (i.e. for use at other institutions), her IACUC
iinnssttiittuuttiioonnss ppeerrffoorrmmiinngg labels it a commercial product and leaves the oversight
subcontracted research on behalf of the university. up to the producing site. This approach is consistent
According to OLAW, Gerrity’s institution maintains with OLAW guidance on custom antibody production
some responsibility for those animals because her contained in a March 8, 1995, OPRR Report (http://
institution is the PHS awardee institution. grants2.nih.gov/grants/olaw/references/dc95-3.htm).*
Gerrity also suggests that IACUCs clearly think through
all issues surrounding ownership and responsibility,
What can institutions do including questions about who will pay per diem charges
to ensure proper oversight? and who will determine treatment for the animals.
“You also need to think about what would happen to the
Think through the issue of responsibility animals if the principal investigator leaves,” Gerrity says.
“Will the research continue because it’s a well-developed
“Remember that if your institution receives PHS
program and there are lots of people responsible for it?
funding, even if you subcontract or conduct research at a
Or will it stop because that one investigator is driving the
performance site, you have a legal responsibility for the
research and animal use?”
federal funding your institution receives,” Garnett says.
Other decisions include determining which institution
Part of that responsibility is met by simply ensuring that
has the authority to euthanize the animals (should it
all performance sites are covered by an appropriate PHS
become necessary), deciding if the offsite institution
Assurance.
will provide their written procedures for their IACUC,
“The IACUC needs to establish its realm of
veterinary care, husbandry, etc., to the source institution,
responsibility,” Gerrity says. “IACUC members need to
and also what will happen to animals in the event of a
have it clear in their minds what they are responsible for.”
disaster.
Gerrity’s institution has defi ned responsibility a bit
broader than others. “But our IACUC has said, ‘this is *OPRR Report 95-02 states “In the case that standard
how we’ve defi ned responsibility for ourselves, based reagent antibodies (e.g. mouse-antihuman) are produced
on our interpretation of AAALAC, OLAW, and USDA.’” by a commercial supplier using their own resources and
Gerrity says. “We vvvooollluuunnntttaaarrriiilllyyy sseett aa hhiigghheerr lleevveell ooff offering them for general sale, for example, through a
oversight—this was not required, it was our choice.” catalogue, the institution may consider the antibodies to
At the start of any arrangement, IACUCs must answer be ‘off-the-shelf’ reagents, and the supplier is not required
questions about which committee will have fi nal say in to fi le an Assurance with OPRR. If, on the other hand, a
care and use issues. “Determine which committee has supplier or contractor produces custom antibodies using
priority of review up front,” Stark says. “Is it the person antigen(s) provided by or at the request of a principal
who gave the animal to you and still owns it—or the investigator, the antibodies are considered “customized”
person using it?” and the vendor or subcontractor must fi le an Assurance
with OPRR.”
Develop clear criteria
Create detailed agreements
Defi ning the boundaries of responsibility includes setting
criteria for determining the IACUC’s role in overseeing As a member of AAALAC’s Council on Accreditation,
animals and studies at offsite facilities. “You have to Stark has visited several institutions that keep animals at
develop criteria to identify those offsite studies that will other facilities but have no formal agreement with them.
require IACUC oversight,” Gerrity says. “While these institutions haven’t faced any problems
For example, some questions to help determine the yet, it would be wise for them to outline the specifi cs
institution’s role in oversight might include: Will the of their arrangements—whose committee is ultimately
animals be used for research, teaching and testing? Will responsible, what type of animal care and use procedures
they be cared for and used at a site registered with the will be allowed, and so on—so that there’s something
USDA? Does the site have an approved PHS Animal in writing,” Stark says. “Then if there’s is a problem, it’s
Welfare Assurance on fi le with OLAW? Is the program covered. Even though the USDA doesn’t require it, you
AAALAC accredited? really should do some formal assessment of how things
Many times IACUCs will need to make judgment calls will be handled.”
AAALAC Connection AAALAC Connection