Let me introduce you to the leader of the team that's
concerned specifically with implementing the preventive
standards provisions of the new law.
Don Kraemer is the Acting Deputy Director of CFSAN.
Don, let's talk first about prevention controls
in facilities.
How important are they?
How's it going to work?
How is F.S.M.A.
mandate all this?
So preventive controls are just that, they're a system that
a manufacturer would put in place to first, identify what
are the hazards that that product might be associated
with, and then to have a set of scientifically established
controls that are designed to minimize the risk of occurrence
of those hazards.
Who comes up with these controls?
Is this something the FDA tells the facilities, or is it
a collaborative process?
What happens?
The processor is responsible for establishing the controls.
Of course, FDA is in a position of providing guidance to help
that process along.
And how quickly do these controls have to be in place?
Well, the process has really just begun.
The legislation, just a couple months ago.
FDA is now in the process of drafting what we call
a proposed regulation.
The next step is that the interested parties can submit
comments to the agency.
And we then consider those comments.
And then we write a final regulation.
So, this isn't something that a facility is going to have
to come up with in a couple of days and go forth.
This is a process?
Right, there's still time.
I encourage folks to get started, of course,
but there's still plenty time to get these plans in place.
And do all of the requirements apply
to all facilities?
No.
The legislation has some specific exemptions based on
size and who the facility distributes to, whether they
ship to retail, and that sort of thing.
So there are some facilities that will not be covered
by the regulation.
Is that risk based or size based?
The legislation specifically provides exemptions for size.
FDA is also charged to look at certain low risk activities,
especially ones that occur on the farm, that might be
manufacturing, but are still very low risk.
And to put exemptions in place, if we think that's appropriate.
So let's talk about things on the farm, specifically mandatory
produce safety standards.
Again, how does F.S.M.A.
treat these?
How does it work with what's going to happen there?
Okay.
So again, the legislation charges FDA to write
a regulation here.
It again, is designed to reduce numbers of illnesses that occur,
in this case from produce.
So, we've had a process for the past year or so, where we've
done some listening sessions around the country, trying
to understand what this sector is like.
Don, the major paradigm shift in this legislation,
is the focus on prevention, and the fact that we are holding
industry and individual growers responsible
for these kinds of actions.
But, as our role, as verifiers of that, how do we do that?
Well, the first step is education.
What I think's going to be very important is another piece
that's being developed, and that's this
self assessment tool.
We think it's going to be very reassuring for a farmer, who
maybe hasn't experienced this kind of oversight before, to be
able to assess their own operation and say, "Looks like
I'm in pretty good shape, so I'm not worried about the inspection
should it happen someday."
Seems like a win-win for everyone.
Nobody wants to get sick and no one wants
to lose their business.
I think that's very true.
The purpose of all of these regulations is to reduce
food borne illness.
Food borne illness is a problem for everybody, not just
the consumer, but the regulatory community, and of course
the manufacturers and the producers of food, as well.
Recalls because of contamination or illness, are very expensive,
and not at all good for the industry.
So we think it is a win-win for everybody.
Don Kraemer, thank you very much.