Current Viewpoints from Regulators and Peer Review

Current Viewpoints from Regulators and Peer Review


John Bradfield: Morning. Volume okay? Thanks
for uh, letting me come down to the podium and talk to you for a few minutes about AAALAC’s
perspective on this issue. I will uh, I will confess however that I’ve been struggling
a little bit throughout the morning. This is an audience of very highly educated people.
Am I the only one that there’s this sort of Pavlovian dread by the notes on the board
here? Just brings back, uh, well. I recall this recurring dream I have where I’m back
in college, and I have to make it my way to the final exam in calculus, it’s always calculus.
I’ve not been to class all semester, I can’t remember where the class is, I’m not sure
when the exam is, and this awful sensation that I’ve got to sort of measure up and pass
this exam, and I always wake up in a cold sweat. So I don’t know if I’m the only one
who has that, but I’ve been struggling all morning. That’s exactly what that means, yes.
I pushed the wrong button. Let me try another one. I’ll just push buttons until something
happens and we’ll, we’ll go with the flow. Uh, so I’m gonna give you the AAALAC perspective
and then I’ll drift around a little bit, I do that intentionally, um, there’s been a
lot of discussion on this topic, particularly, recently, since the implementation of the
2011 Guide. That’s both been true with the AAALAC counsel level, and I’ll go into some
of that, and our industry as, as a whole. Um, so is this something new, and the answer
for AAALAC is no, not really, there’s not been any great change in the way AAALAC views
this issue. Um, the 96 Guide did have language about social housing, page 22 example here,
sort of, sort of puts in context a lot of what we’ve heard already this morning and
that conspecific social interaction should be uh, allowed either between or within enclosures,
and then this comment on page 26, now this is, again, the 96 Guide whenever appropriate,
social animals should be housed in pairs of groups. Three statements, I, I won’t say my
search of the 96 Guide was exhaustive, but this is what I turned up. So, it’s not a new
topic, but, nor, is it confined to these three previous statements in the Guide. So if we
look at the 2011 Guide, um, we see a lot more references involved here. In fact, I’ve found,
as we all have, entire sections devoted to social housing of animals. Now this is across
all species. This is animals in the lab so to speak, whatever the lab may be, whether
it be a field study or in a biomedical setting. 33 different text references in separate,
24 separate pages referenced. The Guide has a lot more to say today than it did several
years ago. Hence our discussion, so it stimulated us to think about this topic in a renewed
way. Veterinarians have done this and IACUCs have done this and researchers have done this
from a variety of different angles, but the Guide I think now challenges us to sort of
level the playing field and think about where we are with this topic. A lot more discussion.
Um, Dr. Watson, AAALAC council member, and he’ll remember this when the 2011 Guide came
out, these comments in the Guide, I’ve pulled these out in particular, prompted the AAALAC
council to think long and hard about what is it that AAALAC expects, what do these statements
mean, and how are we going to assess programs, as to whether or not they’re achieving these
goals? Single housing should be the exception. A should in the 2011 Guide is a strong recommendation,
so the council really debated this language. What does this mean? What do we expect? The
answers weren’t terribly clear. Um, the next one includes what I call a should/must dichotomy.
The Guide has this in a variety of places, and boy it creates heartburn at AAALAC. So
I don’t know if you can pick this out in this bullet point number two here, an appropriate
housing space or enclosure should account for the animals’ social needs. Nice, easy
thing to say in one sentence. They should be housed in stable pairs of groups, compatible
individuals unless they must be housed alone. So there’s a should/must thing there, there’s
sort of this implication that we should do this because it’s benefited the animals, but
if we’re gonna single house, there is a must kind of flavor to that, so what does that
mean? So, the long and the short of it is, is that AAALAC developed this position statement
which is sort of a, a proclamation of the direction AAALAC is gonna take on this issue.
It’s sort of a rule of the day, so to speak. It’s uh, telling the scientific community
that, this is AAALAC’s view of this topic, and I’ll get to that in a minute. It’s not
anything new, it’s been out for a couple years now. Also an FAQ to sort of go hand and glove
with this, uh, position statement to provide some guidance about what we expect. Before
I get to that, I’ll uh, briefly mention an analyses of all the findings discussed at
AAALAC’s sight visit exit briefings since the uh, we’ve began using the 2011 Guide.
4815 findings, 671 sight visits, so it’s a big, robust data set. This is the program
components in where we tended to find the most and the least findings. And you can see
that the blue slice of the pie there is animal environment, occupational health and safety,
and then the green larger area is IACUC issues. If we look a little closer at this animal
environment section, about 23% of all those findings in animal environment relate to issues
of social housing. So in that blue section of the pie, the animals environment, almost
25% of the time, we’re talking to you about concerns we may have about social housing.
So that’s what the data shows. Let’s get to the position statement. AAALAC sort of rephrased
the terminology of the Guide and we said we think that should be the default method. We
understand that that’s a paradigm shift. It’s not necessarily the long-standing method,
so based on the verbiage of the guide, and the council was very careful and intentional
about this language, we expect it to be the default. If there is single housing, there
should be justification for that. Based on three broad areas. Incompatibility, behavioral
incompatibility of the animals, veterinary concerns, or scientific necessity. When you
do single house, I want you think about some specific issues very carefully. Number one,
there’d be limited to minimum period necessary. If possible, maintaining visual, olfactory
and protected contact, we’ve heard a lot about that this morning, and the pluses and minuses
associated with that. Again for appropriate species. If there is single housing, we expect
you to think about environmental enrichment in a very careful way, and augment that when
it’s appropriate. An appropriate positive human contact, and intermittent full contact
and play or exercise areas, considerations for those things when animals must be singly
housed. When they are singly housed, it’s not sort of a, �okay forever� kind of
arrangement, we think at AAALAC, that the IACUC and the AV, and probably the investigator
need to rethink this paradigm for those singly housed animals on a regular basis. How often?
Probably depends on the science and the animals and the context of your institution. But I
think we can state this another way. People have had a lot of confusion about AAALAC’s
point of view on this, and I think, I think this captures it. It’s the default mechanism,
social housing, but if you have to singly house, it should be an intentional decision
on the part of the PI and the IACUC to do so, based on those three broad areas of justification.
The bottom line is when the sight visit team comes in the door to do an evaluation of your
program, we expect it will probably see some singly housed animals, and we’ll ask about
that. And if you’ve sort of have your ducks in a row, yup the IACUC knows about it, it’s
justified either in the protocol or by some other method, here’s why, and there’s a rational,
logical, careful, thoughtful process for single housing, we say okay. If we get the deer in
the headlights looks, like, d’oh, we forgot about these animals, then we’re gonna say
that’s not okay. Social animals need to have the consideration for social housing. And
that’ll be a topic of discussion at the exit briefing. So the AAALAC FAQ provides a little
bit more detail on sort of what we think when we’re talking about social housing and, and
what we mean now, now when we say social housing, we mean full time pair or group housing. Continuous.
There’s some debate about whether or not that’s right, but that’s sort of the AAALAC opinion.
The FAQ goes one step below further and we think this, uh, issue of social importance
of this social and environment of animals is a spectrum. On one hand you might have
complete isolation, hopefully we don’t see this, uh, at all, or rarely, maybe when there’s
a scientific necessity perhaps, but frankly we don’t see this very often. So that’s one
end. The other end is full-time continuous housing. But there’s more to it than that.
In other words we think it’s not an all or none decision. The science may dictate that
they can’t be group housed, but there may be other things you can do, we’ve heard about
this this morning. I thought I had all these novel messages to deliver, turns out I’m just
reiterating what others have said. So it’s a continuum. Um, single housing, maintaining
other sorts of visual, auditory, or factory, um, contact with conspecifics. Now I’m beginning
to wonder about our definition of conspecifics and what that means. Thank you very much.
Protected contact may be a little bit further along this spectrum. The FAQ describes uh,
these as other considerations other than just the all-or-none yes-or-no full time social
housing. And then finally part-time group housing, play or exercise areas, the term
intermittent housing earlier, I like that term. So it’s a spectrum. If you have trouble
with full time housing, it’s not immediately full-time single housing. There may be other
strategies you gotta think about that. We need to slice this issue in a little bit more
granular terms. So the council’s thinking about this when we do site visits as they
come in the door. When there is single housing, uh, we’re looking for the institution to have
paid a bit more attention to augmented environmental enrichment. So if single housing is required
by some means, so what do you do? Um, I won’t go into environmental enrichment, but this
is another issue in, in, in which we’ve sort of taken an all or none approach. We’ve put
a few things in the cage and we say Gosh that’s good, and we walk away, we’re not sure if
it’s relevant, salient to the animal, meaningful, maybe causes stress, maybe it spreads disease.
There are a whole host of issues with environmental enrichment that we expect you to consider
carefully. So, species-specific relevant to those species considering both their psychological
and their physical needs addressing sensory and motor needs, the ag-guide has sort of
five areas they define. I like this. There’s social enrichment, occupational, which is
more loco motor or task oriented kinds of enrichment. Physical sensory and nutritional,
it’s how the ag-guide defines it for farm animal species. I like that terminology. Also
increased positive human contact, and we’re looking very carefully for this, increased
behavioral surveillance. If the site visit team, comes in and finds singly housed animals,
and they’re healthy, they’re well adjusted, no aberrant behaviors noted, that’s one scenario.
A lower level concern, we’ll ask about it, whether it’s justified, but if we find aberrant
behaviors, and issues associated with those singly housed animals, we’re gonna be more
concerned, because we had behavioral problems evidenced, and we’re gonna ask you about that.
Have you seen these? Are they on your radar? Were they noted as abnormal? Does the IACUC
know about that? Are you watching that? All sorts of downstream questions will follow
depending on what we see in the cage. So that goes to staff training and experience as well
as the IACUC’s role in being informed about the social experience of these animals. Which
brings up the role of the IACUC. We think that they’re the hub of the wheel like most
things and certainly on this issue we expect the IACUC to set the institutional expectation
for social housing. That 23% of those animal environment findings I showed many times the
IACUC was just not addressing this issue. I can tell you when that occurs when the IACUC
says yeah well you know, we thought about it but we just haven’t really tackled this
problem yet. The Council will call that a mandatory deficiency. So that’s a serious
concern that the IACUC has sort of failed in its role to consider the social needs of
the animals. When you do have single housing there are many ways to sort of consider and
improve that. It’s a matter of scale, it can be protocol by protocol or justification,
maybe the needs of the science dictates social housing. Maybe within species issues, maybe
housing boars together has been completely unsuccessfully at your institution � likely.
So why keep trying to do that? Maybe there’s an exception based on male mice or male boars,
male boars, or boars. Or males of any particular species so there might be a program wide consideration
of this issue that you’ve thought about and the IACUC has sort of made a policy. It’s
a matter of scale. If you only had a few exceptions, protocol by protocol probably makes more sense.
If you’re breeding institution with 50,000 mouse cages, justifying every male mice being
singly housed might get a little onerous. We’re not suggesting that you have to do it.
So it’s a matter of scale. It’s a good idea to document the IACUC’s logic when they approve
single housing. Not just for AAALAC, we’ll be interested in that, but also so you can
be consistent in your decision-making about this issue. We expect the IACUC to monitor
single housing and the effects of social housing, the success of the social housing program,
and monitor those behaviors and interventions associated with aberrant behaviors. So I digress
here a little bit from AAALAC, considerations I think that’s pretty straightforward, AAALAC
says if you’re going to single house animals it has to be intentional. It has to be on
purpose. You have to have a good reason to do it. That’s pretty straightforward, that’s
kind of the end of the AAALAC message. It’s not that quite simple though is it? We all
know better. In consideration of the science, I mean in most of our programs that’s why
they’re there. The duration on study might be an impact if you have a few rabbits on
study for two weeks that’s different than some antibody producing rabbits that might
be in the facility for three years. Two different scenarios. So the science, duration on study
is really impactful. What is their normative behavior? You’ve heard excellent remarks about
this already both in nature as well as in the lab. What is their social repertoire and
aptitude? How likely are they to succeed in the social group settings? And others more
experienced than I have already commented on these issues. I think we’re a bit na�ve
sometimes when it comes to things like individual variation. I’ve been guilty of this, I’m a
veterinarian, I’ve spent a lot of time trying socially house rabbits, and I started that
process thinking they’re rabbits. They’re all the same. They all look the same. They’re
all New Zealand white bunnies. Let’s just-, they all behave the same, right? Wrong. Those
of us that have tried that realize that we were really very na�ve and very ignorant
in our expectations of what success was and how difficult it might be to achieve that.
For all sorts of reasons. So now we understand this is kind of more complex. We must not
forget that we live in a practical world and we have to consider sort of this cost-benefit
analysis both this is true and looking at the animals it’s also an institutional perspective.
We can’t ignore this. How do we know that social housing is working for our program,
for these animals, and for the science? We know that there’s stressors and conflict associated
with social housing, how do we measure that and the impact that has? It’s not an all or
none easy yes or no black and white kind of issue. It has an impact on the science no
question about it. As does single housing. But we’ve single housed over the years and
so scientists have come to expect that as sort of the norm, so if we shift to a social
setting, then all of a sudden we’re shifting maybe some scientific measures. We have to
acknowledge that we’re impacting that science. It’s not necessarily good or bad, it’s different.
Although we tend to characterize any change as bad because we don’t like it. But we know
that social housing will induce a lot of change in some of these scientific measures, we have
to acknowledge that. PI’s have a real concern about the things that we do at the cage side
and for good reason. Kate did an excellent job this morning of raising this point of
managing conflict, and we get this question a lot at AAALAC. Well we got in some bunnies
and we put them together and it was World War III so we stopped and we’re done with
that. And so is that good enough, and that’s a tough question, I’m not sure we at AAALAC
know the answer but we’re going to expect a good faith attempt to really make this work
and sometimes you say well it doesn’t work for these animals or for these groups of animals
but to try once and sort of hang it up probably doesn’t meet the requirements at least in
our view. What exactly is a good faith effort? We expect you to define that. We’re going
to ask you that question. But we get asked that question a lot. So what constitutes a
failure and you have to resort to single housing. Tricky issue. And then there’s institutional
resources. We see this all the time. Well we house our rabbits singly because that’s
all the cages we have, and if we go buy different cages that $750,000 we don’t have. So this
is not a trivial issue. Whether or not it’s a justification that’s a tricky question but
the practical issues do come into play. We see this all the time. We’ve given institutions
at AAALAC a period of time to buy caging, implement new strategies because there are
costs in changes associated with that. But managing the institutional resources of the
program is a real issue. So some trend data, I’ll go quickly through this. This is a little
finer look at that blue section of animal environment. So if we look at all the findings
in the animal environment category, husbandry issues are the most numerous, sanitation and
then this behavioral and social management third, microenvironment is the cages and macroenvironment
is the facility. So that’s where it sort of falls on the spectrum but if we look at it
a slightly different way, if we look at mandatory findings only, those findings that you must
address to maintain accreditation, almost 58% of all those mandatory findings in the
animal environment relate social housing. So clearly this is a paradigm shift for institutions,
you’re on the path but half of our mandatory findings in this category relate to social
housing. That shows that we have a lot of work to do. If we look at all findings, 4815
behavior and social management was ranked third amongst the most commonly cited mandatory
issues. These are cases in which the IACUC has not fully considered the social needs
of the animals. Not institutions that are trying and they have strategies and they’re
working towards that, no, these are institutions where they just sort of forgot. Half of all
mandatory findings relate to social housing in an animal environment so we’re finding
this quite often. We think this will tail off as you get better at dealing with the
strategies. The challenges we see probably won’t surprise anybody. Rabbits? Everybody’s
struggling with rabbits because we thought we could just put them together, and of discussion
but we find that’s not the case. Also some Ag programs where there is a long-standing
history of certain kinds of housing, say with sow confinement, Bernie mentioned this earlier
in the day, there’s been a long history of confinement for gestation or farrowing crates.
If your measure is number of piglets weaned, that looks like a reasonable cage paradigm
but maybe we ought to be looking at other measures with regard to the overall social
complexity of sows. So programs are having challenges dealing with that. Part of that
is caging. Part of that is our thinking. Programmatic uniformity. People think about nonhuman primates,
they think about dogs, we’re thinking about rabbits but sometimes we forget about all
the other species there so IACUCs are not necessarily uniform in the attention they
give to the variety of species at the institution. So we see some ups and downs there according
to species. And the caging, I’ve already mentioned, is expensive, we have to acknowledge that.
So that’s what we see from the AAALAC perspective and I will be quiet. Social housing is conceptually
very easy but it’s very difficult to implement effectively and I think we’ve heard that this
morning and probably will throughout the next day. Thanks.

Author: Kennedi Daugherty

Leave a Reply

Your email address will not be published. Required fields are marked *