December 16, 2024 • 31 mins
Dr. Michelle Danyluk, Professor and Extension Specialist in the Food Science and Human Nutrition Department at University of Florida, provides insight into 7 major FSMA rules that farmers need to know.
Dr. Michelle Danyluk clarifies the relationship between the Food and Drug Administration and the Food Safety Modernization Act (FSMA), highlights proposed legislation yet to be finalized, and provides insight into 7 major FSMA rules including:
1. Produce Safety Rule
2. Foreign Supplier Verification Program (FSVP)
3. Sanitary Transportation Rule
4. Protection Against Intentional Adulteration
5. Accredited Third-party Certification
6. Preventive Controls Rules for Human and Animal Food
7. Voluntary Qualified Importer Program (VQIP)
Resources:
Learn more about food safety and upcoming events and webinars on our website: https://foginfo.org/food-safety-for-producers/
Learn more about FSMA on the U.S. Food and Drug Administration Website:
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:02):
Welcome to Florida Organic Growers podcast series
Food Safety for Farmers.
A project funded by the USDANational Institute of Food and
Agriculture Food Safety OutreachProgram, our podcast provides
information on food safetytopics that farmers can use to
better understand how to complywith the Food Safety
Modernization Act regulations.
Thanks for tuning inregulations.
Speaker 2 (00:29):
Thanks for tuning in.
Hello everyone, Thank you somuch again for tuning in to our
Road to Safe and Healthy FoodProject podcast series.
We're very happy to haveMichelle Danilock with us today.
Michelle is a professor andextension specialist with the
Food Science and Human NutritionDepartment at the University of
Florida.
Hi, Michelle.
Speaker 3 (00:48):
Hey, jc, great to be here.
Speaker 2 (00:50):
Today we're going to be talking about the Food and
Drug Administration, fda, andthe Food Safety Modernization
Act rules, which is somethingthat a lot of our farmers are
probably either familiar with orthey hear these acronyms all
the time.
So we wanted to take a littlebit of time right now to maybe
(01:14):
understand what is therelationship between the FDA and
the Food Safety ModernizationAct, or FISMA as it's often
known.
Speaker 3 (01:24):
Yeah for sure.
So the food safetymodernization act was signed
into law back in 2011.
So 11 years ago now, almost.
And if you can remember backfrom your high school or maybe
middle school civics classes,right, acts are what get passed,
and then out of acts comedifferent specific rules that
(01:46):
propose different sorts ofdifferent, different things for
whatever the act is writtenabout.
So the Food SafetyModernization Act really was a
bipartisan effort that was putforward to modernize the way
foods are regulated within theUnited States.
The way foods are regulatedwithin the United States and I
(02:08):
should caveat that by saying notmeat and poultry products they
had their own regulation thatcame out in 1996 that really
dealt with meat and poultry.
So here we're talking about allthe other types of food that
don't fall under that 1996regulation for meat and poultry,
the meat and poultry, and itreally is the first new food
(02:30):
safety regulation that we've hadwithin the United States to
cover all our foods except meatand poultry Since back in the
early 1900s.
We haven't had a modernizationof the way we regulate food
since that time Again, with theexception of meat and poultry
and seafood, and then there wasalso a juice rule that came into
effect in about 20 years ago,in the early 2000s.
So it was a huge effort thatwas assigned to FDA to really
(02:55):
modernize the way we look atfood safety within the United
States to make it proactiveinstead of reactive.
Historically our food safetyregulations, again from over 100
years ago, have been veryreactive in nature.
So it was really to beproactive, so that everybody was
trying to prevent theseoutbreaks of foodborne disease
(03:16):
instead of just reacting to themwhen they happened.
And so out of the Food SafetyModernization Act, which we call
FISMA I think much to thechagrin of FDA or the early
chagrin of FDA we got reallyseven different rules out of
that, out of that, out of thatact, and that I think we're
(03:39):
going to chat through a littlebit today.
Some of those rules are stillproposed.
They're not final, but we'lltalk through what we've got and
what's missing.
Speaker 2 (03:47):
Absolutely.
And so, yes, you mentioned andI was going to ask or confirm
with you that right now we aretalking about seven rules, and
one of the rules that Iunderstand is sort of one that
maybe our farmers are familiarwith is the produce safety rule.
Speaker 3 (04:09):
Yeah, so the produce safety rule is sort of what we
think about as the first timeever that farmers and that the
farming community has reallybeen regulated by the federal
government in terms of foodsafety.
So it's a groundbreaking effortin terms of it's really the
first time that we've looked atfederal standards for food
(04:32):
safety all the way back in thatgrowing environment on the farm.
Speaker 2 (04:38):
And then the other rule that I have heard but don't
really know a whole lot aboutis the foreign supplier
verification program.
What is that?
Speaker 3 (04:51):
Yeah, so that is another one of the FISMA laws
and I think we should go backand touch a little bit more on
the produce safety reg.
But I think it's great.
Yeah, but it's great to touchon foreign supplier verification
first, because I know a lot ofour growers in the United States
are worried that importers offresh fruits and vegetables are
not being held to the same highfood safety standards that they
(05:15):
are, and so the Foreign SupplierVerification Act is the way
that FDA is holding thoseimporters to make sure that
produce and other food productsimported to the United States
meet the high requirements ofthe produce safety rule.
Speaker 2 (05:34):
That's a little bit like us here at Florida.
Organic Growers can sort ofrelate in terms of organic foods
.
We know what the certifiedorganic farmers here in the
States you know have to complywith, and then the question
sometimes is well, what aboutpeople who want to sell you know
banana, organic bananas comingfrom overseas?
(05:55):
You know they can trust that inorder for that product to come
into the States, it has tocomply with and go through the
same process that farmers herein the country have to comply
with and they get inspected.
And so my understanding is, asyou pointed out, that that also
applies for stuff that's comingout of the country.
Speaker 3 (06:16):
Yep, absolutely, yeah , absolutely Exactly and in an
exactly similar way.
And so we circle back around tothe produce safety rule.
This, this rule really appliesto farms growing fresh fruits
and vegetables meant for humanconsumption, um, and so I'll
tell you, fda has someinteresting definitions of what
(06:37):
they call fresh fruits andvegetables, and they, they have
a list of products that are notfrequently consumed raw.
And so it's interesting, right,because and I will tell you
that this list has evolved overtime and I think will continue
to evolve, because you knowthere's a lot of different
(06:57):
produce out there, right, andyou know.
So you think about somebodygrowing some of these Asian
green vegetables, right?
And I'm sure you've got folkson your call growing them.
Well, I can tell you, fdaprobably has not heard of all
the different types of fruitsand vegetables that the growers
listening to this call aregrowing.
So they're still evolving thatlist of rarely consumed raw, but
(07:19):
they've also exempt from therule, um, growers that are
really small, um, so those,those folks are exempt from the
rule, and then also exempt fromthe rule are, um, somebody
that's growing fruits orvegetables that are going into
processing, so if it's goinginto something like freezing or
it's going into a can, or ifit's going into make make juice,
(07:42):
then those are exempt from theproduce safety rule as well.
But otherwise, growers growingfresh fruits and vegetables are
covered by this rule and, again,it's the first time there's
been a federal rule to covertheir activities.
And I'll tell you, one of thethings I like the most about the
(08:03):
way that FDA has put this ruletogether is that they have
realized that they, as FDA,can't enforce it.
So they're working closely withtheir state collaborators and
those states are the onesactually doing the inspections,
which I think is really good forour growers, right.
Which I think is really goodfor our growers right, because
we know that, like here inFlorida, the folks at the
(08:25):
Department of Agriculture herein Florida have a really great
understanding of what's going onin Florida and what the farms
here should look like, and don'texpect them to look like
something else.
Speaker 2 (08:49):
So I think that's very, very important and thanks
for, you know, sort ofclarifying that.
So we've talked also about this.
You know again, the foreignsupplier verification program
and stuff coming, you know, fromoverseas.
Is there anything else thatmaybe farmers should know about
(09:09):
that in?
Speaker 3 (09:09):
terms of you know what that really means.
Yeah, yeah, it's interestingwhat that really means.
So there's a lot of aspectscovered in the produce safety
rule.
Right, it applies to growersand it talks about really five
main areas worker training andworker health and hygiene, soil
amendments of animal origin,intrusion of wildlife and other
(09:31):
animals, water use and cleaningand sanitizing.
Right, are there really fivesort of focus areas of what the
produce safety rule looks at?
What the preventive controlrule does is it requires anyone
who is the importer of freshfruits and vegetables or, like I
said, any food commodity, toreally make sure that the foods
(09:54):
that they're importing meetthose same requirements as were
in the produce safety rule, andI think it's really interesting
because it puts that onus onunderstanding and ensuring the
food safety in the producesafety rule or other rules.
(10:34):
And what I think is sointeresting about this is when
you think about the way a lot ofproduce is imported right, it's
imported by brokers, right?
Brokers who might neveractually see or touch the
product, yeah, or brokers who'vemaybe never visited the farm
that they're importing theproduct from, but this rule puts
(10:54):
the onus on them now to be ableto prove that it's met that
same safety minimum.
So I think there's a ton ofwork that needs to be done in
that import community to makesure that they are actually
doing this.
And I know this is the foreignsupplier verification rule is
(11:15):
one of those rules where we haveseen a lot of FDA activity in
terms of inspection andregulation, and it's one that I
think we will continue to seeactivity on, because it really
is out there as the rule thatputs on the importer here in the
US the onus of proving thatthat food from overseas has been
(11:37):
produced to the same standardas our domestically sourced food
.
Speaker 2 (11:43):
So what about?
Because it sort of leads me tothink whether we're talking
about, you know, importers, orthe way that the food that is
coming from overseas gets here,or even here in the country, and
the, I guess, thetransportation.
Is there anything abouttransportation or rules when it
(12:05):
comes to the way that produce ismoving from one place to the
next?
Speaker 3 (12:10):
Yeah, so you've hit it right on the head, jc.
There is another rule out therecalled the sanitary
transportation rule, and thisrule looks at the risk posed to
food products from how it'sbeing transported.
Now, I think important for ourtransportation from a field to a
(12:33):
packing house.
That activity of transportationis covered in the produce
safety rule here.
What we're talking about reallyis that transportation sort of
once our product is ready to goto market, all the way through
the chain until it gets to itslocation.
So we're talking about thecontainer ships that might be
bringing produce in fromoverseas, we're talking about
(12:56):
those reefer units that might bemoving produce across the
country to different operations,and it requires that those
folks that are doing thattransportation uphold the
application of risk-basedpreventive controls for hazards
(13:16):
during that transport.
And so I'll tell you,historically, the reason that
this came out was due to somesome allergen concerns and some
other concerns, especially whenyou look at tanker trucks and
difficulty of transportingliquid, liquid food products and
cleaning those inside of thetanker trucks.
Yeah, that's sort of where,historically, how I like to
think about it.
But it really does go beyondthat because it requires those
(13:39):
folks, the transporters, tocomply with transport standards
and that includes things likeproper temperature, right,
keeping the temperature, theright temperature, so you're not
getting folks switching off therefrigeration in their trucks
if it costs too much money.
We're looking at sanitaryoperation and really cleaning
out those vehicles and makingsure that they are not a source
(14:03):
of contamination.
And, like I said, it applies tothe motor, it applies to rail,
it sort of applies to a lot ofdifferent ways of shipping
product.
It doesn't apply, unfortunately, to the actual physical ship or
the air transportation, but itdoes require a bunch of
(14:25):
different standards Again,really making sure that these
equipments are properlymaintained and cleaned and
sanitized and cleaned andsanitized.
Speaker 2 (14:36):
I was going to ask does that mean that there's got
to be some sort of records orevidence to show and that you
know actually get audited orinspected or requested?
Speaker 3 (14:43):
Yeah, it does require proper record keeping for any
sort of cleaning or sanitizing,for the training of the folks
doing that, monitoring formsagain for things like cleaning
and sanitation and temperature.
Those are all required by thisrule, I will say.
(15:03):
The law also requires foodbusinesses to submit to FDA's
authority if they want to do anon-site visual inspection,
especially if there's been somesort of a report of some sort of
a problem with the business Foryour growers.
I do want to highlight oneother thing.
Produce is an interestingcommodity, right, because we
(15:25):
often think about food beingsealed in some sort of a
packaging, but for a lot ofproduce those boxes are vented,
right, we've got vents in ourboxes or in our packaging, and
so there's a lot of questionsand there's a lot of research
being done right now on what therisks of produce are
(15:47):
specifically related to thosevents in the packaging, which I
just find very interesting.
Speaker 2 (15:53):
Well, there's that I think sometimes about.
You know, because it's allabout, in my opinion, you know,
as a consumer, trusting what I'mbuying, but when you know
whether it's the packaging orhow it is that I'm getting that
product, is there anything inthe rule that sort of addresses
(16:14):
whether it's either intentionalexcuse me alteration or things
that can happen to food as iteither is being transported or
as it gets to that end user?
Speaker 3 (16:28):
Yeah, jc, you segued perfectly into another rule that
FISMA addresses, and so anotherrule under the Food Safety
Modernization Act is what'scalled the intentional
adulteration rule, or the AIrule is what is commonly
referred to, and what that rulehas to do with really has to do
(16:49):
with food defense and preventingor coming up with a plan to
keep food from beingintentionally adulterated.
And so you know intentionaladulteration are really fancy
legal words.
What that really means is issomebody like coming in and
purposefully putting somethinginto your food product to make
(17:12):
other people sick, whether it bea chemical toxin or or a
bacteria or or something elseinto your food product to make
other people sick, whether it bea chemical toxin or or a
bacteria or or something else,into your product?
Um, and there are a couple of.
There's a classic example ofhow, um, of how something can be
intentionally adulterated andand sort of the.
The best case example happenedout in State where a cult group
(17:37):
was trying to influence a localelection, and so they went and
put salmonella all over a saladbar in a restaurant, trying to
make a lot of people sick.
Yeah, and so all those peoplewho became sick then couldn't
vote in the election and theirpreferred candidate could be
elected.
So there are examples of this.
(17:59):
Certainly, post 9-11, we saw alot of FDA interest in this area
.
Right, because you could I meanyou could see a terrorist, this
being a possible way for aterrorist to again make a lot of
people sick.
Yeah, especially if we talkabout maybe not the bacterial
toxins or bacterial pathogens,but if we talk about, like, some
(18:21):
of the chemical or bacterialtoxins or chemical contaminants.
Right, you put something likethat into a water supply or into
a milk supply with widedistribution, you can make an
awful lot of folks sick.
So you know, the FD, this isthe one.
I think that for me, is likeCSI foodborne outbreak, where we
(18:42):
, you know, talk about reallysome bad actor going in and
intentionally making productssick, and so really, this whole
regulation requires people tobuild a food defense plan.
Now I will say this this is notrequired by farms.
This is really about foodmanufacturing companies and they
(19:03):
have to build their own plansand use that strategic document
to address how they're going toprevent the potential of right,
intentional adulteration or abad actor intentionally adding
something into their, into theirfood product as a as a
(19:24):
terrorism activity.
Speaker 2 (19:26):
What about something that I that I'm sort of
wondering who is doing in thosecases that we want to make sure
that people are compliant andwhether you know certification
is required Third party, I guesswhat I'm getting at is third
party certification, and I cansort of maybe make a comparison
(19:50):
of who does the certificationfor organic farms.
They're accredited third-partyorganizations that know exactly
what the regulation requires.
Is there such a thing when itcomes to the rules, and is that
part of the rules?
Speaker 3 (20:08):
Yeah, so that is a part of the rule.
It's that there's a wholenother rule on that and it's
called the accreditedthird-party certification and
it's a voluntary program.
So, unlike those other rulesthat are not voluntary, third
party accreditation is avoluntary program.
But it's exactly what you said.
It really is a program wherecompanies or individuals can be
(20:30):
accredited to be a third partyauditor.
This is really important whenwe talk back to that foreign
supplier verification or FSVPrule, because the program is
really targeted at accreditingthird-party auditors so they can
go and do the inspection ofthird-party of those foreign
(20:50):
facilities for the importers.
So it's very much like you justtalked about for organic foods.
Again, it really is trying tomake sure we have those auditors
out there who understand therules that they are auditing to
to really again make sure thatfood coming into the US is very
(21:12):
safe.
Speaker 2 (21:14):
So I think that's one , two, three, four, I think,
five rules.
What is another rule thatperhaps we haven't discussed yet
?
Speaker 3 (21:25):
Yeah.
So there's a couple rules thatwe haven't discussed yet and
those both fall under the sortof large category of preventive
controls rules.
And so preventive controlsrules really took the voluntary
HACCP or the voluntary hazardanalysis, critical control point
(21:48):
regulations or requirements forbuyers and sort of put them on
steroids and put them into allfood manufacturing facilities.
Again, with a few exceptions,but really most large food
manufacturers in the UnitedStates and importing into the
United States now fall underthese rules called the
(22:09):
preventive controls rules, andthere's one for human food,
there's one for animal food.
So we'll talk about human food,so we'll talk about human food
first and we'll talk aboutanimal food after.
Yeah, but so what those rulesdid is they really took again
those HACCP principles andbrought in a bunch of other
things into the rules.
(22:30):
So companies that do have apreventive control plan, they
need to do a hazard analysiswhere they look at all the
potential hazards that could bein their food product, not only
(22:56):
looking for biological, physicaland chemical hazards, but
within that chemical hazardclass we also have to include
radiological hazards, and thatreally came through from sort of
the nuclear meltdown atFukushima over in Japan and the
potential for radioactivematerial to get into our food.
Then, like a HACCP they have todo, after they identify hazards
and do a hazard analysis, theyhave to put in preventive
(23:17):
controls and they bucketpreventive controls into four
different categories ofpreventive controls that have to
be maintained.
They have what they callprocess preventive controls.
Those are preventive controlsin the process where you have to
, you know, make sure you'resystem is operating the way you
(23:38):
think it should be operating.
So whether that's maintainingsanitizer level in a dump tank
or heat treating to a certaintime and temperature standard,
those fall under processpreventive controls.
They have something calledallergen preventive controls and
that really is to preventsomething from being mislabeled
(23:59):
with the wrong allergeninformation in it, so really
focused around labeling andcleaning and sanitizing.
They have something calledsanitation preventive controls
and this is really to preventenvironmental pathogens from
getting onto products from afood facility.
And then they've got somethingcalled supply chain preventive
(24:22):
controls, which are what you putin place if somebody else along
your supply chain is going tocontrol a hazard for you.
So it really builds out thisvery comprehensive food safety
program.
It also requires everybodyfalling under the preventive
control rule for human food havea really comprehensive recall
(24:42):
plan to make sure that thoseproducts can be recalled
appropriately if there is needfor a recall.
So it really does build out avery, very comprehensive food
safety plan for those within themanufacturing sector.
Speaker 2 (24:59):
And I think we're down to the last rule and, if
I'm not mistaken, is that onethat is related to importers.
And you know we were talkingbefore as we're going down
through the, through the rules,the foreign supply verification
program, but is there, is thatlast rule related to that?
Speaker 3 (25:24):
Yeah, so the voluntary qualified importer
program is really linked backinto that foreign supplier
verification program that wetalked about above, and what it
is is a fee-based program sothat foreign food facilities
that intend to import theirproducts to this company can
(25:45):
become registered and verified,so that it really speeds up a
process of inspection andevaluation of their products
coming into the US, whether theybe for food or animal
consumption coming into the US,whether they be for food or
animal consumption.
Speaker 2 (26:04):
Okay, so, michelle, you've shared some, I mean a
really good summary of theseseven rules, but one thing that
I was hoping maybe we can, youknow, discuss in the time that
we have left.
I understand that there aremore, if not new, proposed
regulations.
If ESMA has some newregulations, can you maybe give
(26:27):
us a little bit of a summary oroversight of what that is?
Speaker 3 (26:32):
Yeah, there are a number of them out there.
Probably the one that thelisteners to this might have
heard the most about is the, thefood traceability program.
You know, and I think I think Italked a little bit when we
talked about the preventivecontrol rule, about recalls I
think traceability is a hugeissue within within food in
(26:56):
general and I think especiallywithin within produce, where
we've got perishable commodities, um, one of the one of the
things that that rule that ruleis really sort of bringing
itself together to do, is reallyhelp people or require people
to have very good traceabilityum of of their products.
And so Frankie Honest, who's adeputy commissioner over at FDA,
(27:21):
used to work at Walmart beforehe moved over to FDA, and a
story that he's fond of tellingis that one day he asked his
team at Walmart to tell himwhere the mangoes in his package
of fresh cut mangoes came from.
And I won't, I won't tell youthe whole story, but, okay,
needless to say, they couldn'tdo it very well or very easily,
(27:43):
right?
And and I think that's truewith a lot of fresh produce,
right, we have co-mingling, yeah, label each individual produce
item, and so really, whatthey're working on in this
traceability rule is to come upwith a better way to be able to
better be able to do trace backand accountability when we've
(28:03):
got a food safety issue, and Ido think that's a really great,
great thing for it.
Speaker 2 (28:09):
I certainly do want to know.
You know where my mangoes camefrom.
That's a good story.
I'm actually now curious ofwhat the full story is, but you
know, I certainly think that ourfarmers are going to benefit
from.
You know some of theinformation, or all of the
information that you've sharedwith us today.
(28:30):
Is there things that yourecommend to our listeners when
it comes to these rules and thetopics that we've covered today
and how to find out more?
Speaker 3 (28:42):
Yeah, I mean, I think the number one thing to do is
just do your best to stayinformed and I think, whether
that's working likeorganizations with fog or
reaching out to folks atextension at the universities,
find a way to stay engaged inthe rule.
And I think one of the ways todo that is to engage with FDA.
(29:03):
They have a community listservthat if you do email, you can
sign up for, and they willprobably more often than anyone
wants to send you an email aboutdifferent updates that are
going on in these differentrules.
If you're wondering or curiousabout which of those rules might
affect you, again reaching outto University Extension or FOG
(29:25):
or to FDA as well, there'sdecision trees available on the
website to help see if a ruleapplies to you.
And, yeah, just asking out andasking us for help, we do try to
keep folks as up-to-date aspossible when new rule
information come out, whenthings change.
I mean, like we mentioned atthe very beginning, a lot of
(29:47):
these rules are very, very new.
Implementation and inspectionsare in their very early days,
and so we're seeing evolution ofthem all as folks get more
comfortable with them and wefigure out how to make them work
on all different types ofoperations.
So I think keeping in touch,keeping up to date, doing what
you can, listening to podcastslike this, listening to other
(30:11):
educational content, is great,and then reaching out as much as
you need with specializedquestions about your individual
operations is always encouraged.
Speaker 2 (30:22):
Yeah, and we certainly appreciate experts
like you taking the time to talkto us and to our farmers, our
listeners.
We really, really appreciatethe time you've spent today with
us to clarify and provideinformation about the FDA and
the food safety monitoringsection at Rules.
Michelle, thank you so much.
(30:43):
Yeah, my pleasure, and weinvite everyone to continue to
tune in to our future episodes.
We'll go over more informationto help you understand food
safety.
Don't forget to check ourwebsite for new podcast episodes
and updates and upcomingwebinars.
Please also check us out.
(31:05):
Sign up to receive updatesthrough our mailing list and
feel free to also submitquestions on our website.
Thank you so much.
Speaker 1 (31:17):
Thank you for tuning in.
Visit our Food Safety forFarmers podcast page on our
website, wwwfoginfoorg, to findmore information about episodes
and webinars.
Subscribe to our email list forupdates and submit any
questions you may have aboutfood safety.
Welcome to Florida Organic Growers podcast series
Food Safety for Farmers.
A project funded by the USDANational Institute of Food and
Agriculture Food Safety OutreachProgram, our podcast provides
information on food safetytopics that farmers can use to
better understand how to complywith the Food Safety
Modernization Act regulations.
Thanks for tuning inregulations.
Speaker 2 (00:29):
Thanks for tuning in.
Hello everyone, Thank you somuch again for tuning in to our
Road to Safe and Healthy FoodProject podcast series.
We're very happy to haveMichelle Danilock with us today.
Michelle is a professor andextension specialist with the
Food Science and Human NutritionDepartment at the University of
Florida.
Hi, Michelle.
Speaker 3 (00:48):
Hey, jc, great to be here.
Speaker 2 (00:50):
Today we're going to be talking about the Food and
Drug Administration, fda, andthe Food Safety Modernization
Act rules, which is somethingthat a lot of our farmers are
probably either familiar with orthey hear these acronyms all
the time.
So we wanted to take a littlebit of time right now to maybe
(01:14):
understand what is therelationship between the FDA and
the Food Safety ModernizationAct, or FISMA as it's often
known.
Speaker 3 (01:24):
Yeah for sure.
So the food safetymodernization act was signed
into law back in 2011.
So 11 years ago now, almost.
And if you can remember backfrom your high school or maybe
middle school civics classes,right, acts are what get passed,
and then out of acts comedifferent specific rules that
(01:46):
propose different sorts ofdifferent, different things for
whatever the act is writtenabout.
So the Food SafetyModernization Act really was a
bipartisan effort that was putforward to modernize the way
foods are regulated within theUnited States.
The way foods are regulatedwithin the United States and I
(02:08):
should caveat that by saying notmeat and poultry products they
had their own regulation thatcame out in 1996 that really
dealt with meat and poultry.
So here we're talking about allthe other types of food that
don't fall under that 1996regulation for meat and poultry,
the meat and poultry, and itreally is the first new food
(02:30):
safety regulation that we've hadwithin the United States to
cover all our foods except meatand poultry Since back in the
early 1900s.
We haven't had a modernizationof the way we regulate food
since that time Again, with theexception of meat and poultry
and seafood, and then there wasalso a juice rule that came into
effect in about 20 years ago,in the early 2000s.
So it was a huge effort thatwas assigned to FDA to really
(02:55):
modernize the way we look atfood safety within the United
States to make it proactiveinstead of reactive.
Historically our food safetyregulations, again from over 100
years ago, have been veryreactive in nature.
So it was really to beproactive, so that everybody was
trying to prevent theseoutbreaks of foodborne disease
(03:16):
instead of just reacting to themwhen they happened.
And so out of the Food SafetyModernization Act, which we call
FISMA I think much to thechagrin of FDA or the early
chagrin of FDA we got reallyseven different rules out of
that, out of that, out of thatact, and that I think we're
(03:39):
going to chat through a littlebit today.
Some of those rules are stillproposed.
They're not final, but we'lltalk through what we've got and
what's missing.
Speaker 2 (03:47):
Absolutely.
And so, yes, you mentioned andI was going to ask or confirm
with you that right now we aretalking about seven rules, and
one of the rules that Iunderstand is sort of one that
maybe our farmers are familiarwith is the produce safety rule.
Speaker 3 (04:09):
Yeah, so the produce safety rule is sort of what we
think about as the first timeever that farmers and that the
farming community has reallybeen regulated by the federal
government in terms of foodsafety.
So it's a groundbreaking effortin terms of it's really the
first time that we've looked atfederal standards for food
(04:32):
safety all the way back in thatgrowing environment on the farm.
Speaker 2 (04:38):
And then the other rule that I have heard but don't
really know a whole lot aboutis the foreign supplier
verification program.
What is that?
Speaker 3 (04:51):
Yeah, so that is another one of the FISMA laws
and I think we should go backand touch a little bit more on
the produce safety reg.
But I think it's great.
Yeah, but it's great to touchon foreign supplier verification
first, because I know a lot ofour growers in the United States
are worried that importers offresh fruits and vegetables are
not being held to the same highfood safety standards that they
(05:15):
are, and so the Foreign SupplierVerification Act is the way
that FDA is holding thoseimporters to make sure that
produce and other food productsimported to the United States
meet the high requirements ofthe produce safety rule.
Speaker 2 (05:34):
That's a little bit like us here at Florida.
Organic Growers can sort ofrelate in terms of organic foods
.
We know what the certifiedorganic farmers here in the
States you know have to complywith, and then the question
sometimes is well, what aboutpeople who want to sell you know
banana, organic bananas comingfrom overseas?
(05:55):
You know they can trust that inorder for that product to come
into the States, it has tocomply with and go through the
same process that farmers herein the country have to comply
with and they get inspected.
And so my understanding is, asyou pointed out, that that also
applies for stuff that's comingout of the country.
Speaker 3 (06:16):
Yep, absolutely, yeah , absolutely Exactly and in an
exactly similar way.
And so we circle back around tothe produce safety rule.
This, this rule really appliesto farms growing fresh fruits
and vegetables meant for humanconsumption, um, and so I'll
tell you, fda has someinteresting definitions of what
(06:37):
they call fresh fruits andvegetables, and they, they have
a list of products that are notfrequently consumed raw.
And so it's interesting, right,because and I will tell you
that this list has evolved overtime and I think will continue
to evolve, because you knowthere's a lot of different
(06:57):
produce out there, right, andyou know.
So you think about somebodygrowing some of these Asian
green vegetables, right?
And I'm sure you've got folkson your call growing them.
Well, I can tell you, fdaprobably has not heard of all
the different types of fruitsand vegetables that the growers
listening to this call aregrowing.
So they're still evolving thatlist of rarely consumed raw, but
(07:19):
they've also exempt from therule, um, growers that are
really small, um, so those,those folks are exempt from the
rule, and then also exempt fromthe rule are, um, somebody
that's growing fruits orvegetables that are going into
processing, so if it's goinginto something like freezing or
it's going into a can, or ifit's going into make make juice,
(07:42):
then those are exempt from theproduce safety rule as well.
But otherwise, growers growingfresh fruits and vegetables are
covered by this rule and, again,it's the first time there's
been a federal rule to covertheir activities.
And I'll tell you, one of thethings I like the most about the
(08:03):
way that FDA has put this ruletogether is that they have
realized that they, as FDA,can't enforce it.
So they're working closely withtheir state collaborators and
those states are the onesactually doing the inspections,
which I think is really good forour growers, right.
Which I think is really goodfor our growers right, because
we know that, like here inFlorida, the folks at the
(08:25):
Department of Agriculture herein Florida have a really great
understanding of what's going onin Florida and what the farms
here should look like, and don'texpect them to look like
something else.
Speaker 2 (08:49):
So I think that's very, very important and thanks
for, you know, sort ofclarifying that.
So we've talked also about this.
You know again, the foreignsupplier verification program
and stuff coming, you know, fromoverseas.
Is there anything else thatmaybe farmers should know about
(09:09):
that in?
Speaker 3 (09:09):
terms of you know what that really means.
Yeah, yeah, it's interestingwhat that really means.
So there's a lot of aspectscovered in the produce safety
rule.
Right, it applies to growersand it talks about really five
main areas worker training andworker health and hygiene, soil
amendments of animal origin,intrusion of wildlife and other
(09:31):
animals, water use and cleaningand sanitizing.
Right, are there really fivesort of focus areas of what the
produce safety rule looks at?
What the preventive controlrule does is it requires anyone
who is the importer of freshfruits and vegetables or, like I
said, any food commodity, toreally make sure that the foods
(09:54):
that they're importing meetthose same requirements as were
in the produce safety rule, andI think it's really interesting
because it puts that onus onunderstanding and ensuring the
food safety in the producesafety rule or other rules.
(10:34):
And what I think is sointeresting about this is when
you think about the way a lot ofproduce is imported right, it's
imported by brokers, right?
Brokers who might neveractually see or touch the
product, yeah, or brokers who'vemaybe never visited the farm
that they're importing theproduct from, but this rule puts
(10:54):
the onus on them now to be ableto prove that it's met that
same safety minimum.
So I think there's a ton ofwork that needs to be done in
that import community to makesure that they are actually
doing this.
And I know this is the foreignsupplier verification rule is
(11:15):
one of those rules where we haveseen a lot of FDA activity in
terms of inspection andregulation, and it's one that I
think we will continue to seeactivity on, because it really
is out there as the rule thatputs on the importer here in the
US the onus of proving thatthat food from overseas has been
(11:37):
produced to the same standardas our domestically sourced food
.
Speaker 2 (11:43):
So what about?
Because it sort of leads me tothink whether we're talking
about, you know, importers, orthe way that the food that is
coming from overseas gets here,or even here in the country, and
the, I guess, thetransportation.
Is there anything abouttransportation or rules when it
(12:05):
comes to the way that produce ismoving from one place to the
next?
Speaker 3 (12:10):
Yeah, so you've hit it right on the head, jc.
There is another rule out therecalled the sanitary
transportation rule, and thisrule looks at the risk posed to
food products from how it'sbeing transported.
Now, I think important for ourtransportation from a field to a
(12:33):
packing house.
That activity of transportationis covered in the produce
safety rule here.
What we're talking about reallyis that transportation sort of
once our product is ready to goto market, all the way through
the chain until it gets to itslocation.
So we're talking about thecontainer ships that might be
bringing produce in fromoverseas, we're talking about
(12:56):
those reefer units that might bemoving produce across the
country to different operations,and it requires that those
folks that are doing thattransportation uphold the
application of risk-basedpreventive controls for hazards
(13:16):
during that transport.
And so I'll tell you,historically, the reason that
this came out was due to somesome allergen concerns and some
other concerns, especially whenyou look at tanker trucks and
difficulty of transportingliquid, liquid food products and
cleaning those inside of thetanker trucks.
Yeah, that's sort of where,historically, how I like to
think about it.
But it really does go beyondthat because it requires those
(13:39):
folks, the transporters, tocomply with transport standards
and that includes things likeproper temperature, right,
keeping the temperature, theright temperature, so you're not
getting folks switching off therefrigeration in their trucks
if it costs too much money.
We're looking at sanitaryoperation and really cleaning
out those vehicles and makingsure that they are not a source
(14:03):
of contamination.
And, like I said, it applies tothe motor, it applies to rail,
it sort of applies to a lot ofdifferent ways of shipping
product.
It doesn't apply, unfortunately, to the actual physical ship or
the air transportation, but itdoes require a bunch of
(14:25):
different standards Again,really making sure that these
equipments are properlymaintained and cleaned and
sanitized and cleaned andsanitized.
Speaker 2 (14:36):
I was going to ask does that mean that there's got
to be some sort of records orevidence to show and that you
know actually get audited orinspected or requested?
Speaker 3 (14:43):
Yeah, it does require proper record keeping for any
sort of cleaning or sanitizing,for the training of the folks
doing that, monitoring formsagain for things like cleaning
and sanitation and temperature.
Those are all required by thisrule, I will say.
(15:03):
The law also requires foodbusinesses to submit to FDA's
authority if they want to do anon-site visual inspection,
especially if there's been somesort of a report of some sort of
a problem with the business Foryour growers.
I do want to highlight oneother thing.
Produce is an interestingcommodity, right, because we
(15:25):
often think about food beingsealed in some sort of a
packaging, but for a lot ofproduce those boxes are vented,
right, we've got vents in ourboxes or in our packaging, and
so there's a lot of questionsand there's a lot of research
being done right now on what therisks of produce are
(15:47):
specifically related to thosevents in the packaging, which I
just find very interesting.
Speaker 2 (15:53):
Well, there's that I think sometimes about.
You know, because it's allabout, in my opinion, you know,
as a consumer, trusting what I'mbuying, but when you know
whether it's the packaging orhow it is that I'm getting that
product, is there anything inthe rule that sort of addresses
(16:14):
whether it's either intentionalexcuse me alteration or things
that can happen to food as iteither is being transported or
as it gets to that end user?
Speaker 3 (16:28):
Yeah, jc, you segued perfectly into another rule that
FISMA addresses, and so anotherrule under the Food Safety
Modernization Act is what'scalled the intentional
adulteration rule, or the AIrule is what is commonly
referred to, and what that rulehas to do with really has to do
(16:49):
with food defense and preventingor coming up with a plan to
keep food from beingintentionally adulterated.
And so you know intentionaladulteration are really fancy
legal words.
What that really means is issomebody like coming in and
purposefully putting somethinginto your food product to make
(17:12):
other people sick, whether it bea chemical toxin or or a
bacteria or or something elseinto your food product to make
other people sick, whether it bea chemical toxin or or a
bacteria or or something else,into your product?
Um, and there are a couple of.
There's a classic example ofhow, um, of how something can be
intentionally adulterated andand sort of the.
The best case example happenedout in State where a cult group
(17:37):
was trying to influence a localelection, and so they went and
put salmonella all over a saladbar in a restaurant, trying to
make a lot of people sick.
Yeah, and so all those peoplewho became sick then couldn't
vote in the election and theirpreferred candidate could be
elected.
So there are examples of this.
(17:59):
Certainly, post 9-11, we saw alot of FDA interest in this area
.
Right, because you could I meanyou could see a terrorist, this
being a possible way for aterrorist to again make a lot of
people sick.
Yeah, especially if we talkabout maybe not the bacterial
toxins or bacterial pathogens,but if we talk about, like, some
(18:21):
of the chemical or bacterialtoxins or chemical contaminants.
Right, you put something likethat into a water supply or into
a milk supply with widedistribution, you can make an
awful lot of folks sick.
So you know, the FD, this isthe one.
I think that for me, is likeCSI foodborne outbreak, where we
(18:42):
, you know, talk about reallysome bad actor going in and
intentionally making productssick, and so really, this whole
regulation requires people tobuild a food defense plan.
Now I will say this this is notrequired by farms.
This is really about foodmanufacturing companies and they
(19:03):
have to build their own plansand use that strategic document
to address how they're going toprevent the potential of right,
intentional adulteration or abad actor intentionally adding
something into their, into theirfood product as a as a
(19:24):
terrorism activity.
Speaker 2 (19:26):
What about something that I that I'm sort of
wondering who is doing in thosecases that we want to make sure
that people are compliant andwhether you know certification
is required Third party, I guesswhat I'm getting at is third
party certification, and I cansort of maybe make a comparison
(19:50):
of who does the certificationfor organic farms.
They're accredited third-partyorganizations that know exactly
what the regulation requires.
Is there such a thing when itcomes to the rules, and is that
part of the rules?
Speaker 3 (20:08):
Yeah, so that is a part of the rule.
It's that there's a wholenother rule on that and it's
called the accreditedthird-party certification and
it's a voluntary program.
So, unlike those other rulesthat are not voluntary, third
party accreditation is avoluntary program.
But it's exactly what you said.
It really is a program wherecompanies or individuals can be
(20:30):
accredited to be a third partyauditor.
This is really important whenwe talk back to that foreign
supplier verification or FSVPrule, because the program is
really targeted at accreditingthird-party auditors so they can
go and do the inspection ofthird-party of those foreign
(20:50):
facilities for the importers.
So it's very much like you justtalked about for organic foods.
Again, it really is trying tomake sure we have those auditors
out there who understand therules that they are auditing to
to really again make sure thatfood coming into the US is very
(21:12):
safe.
Speaker 2 (21:14):
So I think that's one , two, three, four, I think,
five rules.
What is another rule thatperhaps we haven't discussed yet
?
Speaker 3 (21:25):
Yeah.
So there's a couple rules thatwe haven't discussed yet and
those both fall under the sortof large category of preventive
controls rules.
And so preventive controlsrules really took the voluntary
HACCP or the voluntary hazardanalysis, critical control point
(21:48):
regulations or requirements forbuyers and sort of put them on
steroids and put them into allfood manufacturing facilities.
Again, with a few exceptions,but really most large food
manufacturers in the UnitedStates and importing into the
United States now fall underthese rules called the
(22:09):
preventive controls rules, andthere's one for human food,
there's one for animal food.
So we'll talk about human food,so we'll talk about human food
first and we'll talk aboutanimal food after.
Yeah, but so what those rulesdid is they really took again
those HACCP principles andbrought in a bunch of other
things into the rules.
(22:30):
So companies that do have apreventive control plan, they
need to do a hazard analysiswhere they look at all the
potential hazards that could bein their food product, not only
(22:56):
looking for biological, physicaland chemical hazards, but
within that chemical hazardclass we also have to include
radiological hazards, and thatreally came through from sort of
the nuclear meltdown atFukushima over in Japan and the
potential for radioactivematerial to get into our food.
Then, like a HACCP they have todo, after they identify hazards
and do a hazard analysis, theyhave to put in preventive
(23:17):
controls and they bucketpreventive controls into four
different categories ofpreventive controls that have to
be maintained.
They have what they callprocess preventive controls.
Those are preventive controlsin the process where you have to
, you know, make sure you'resystem is operating the way you
(23:38):
think it should be operating.
So whether that's maintainingsanitizer level in a dump tank
or heat treating to a certaintime and temperature standard,
those fall under processpreventive controls.
They have something calledallergen preventive controls and
that really is to preventsomething from being mislabeled
(23:59):
with the wrong allergeninformation in it, so really
focused around labeling andcleaning and sanitizing.
They have something calledsanitation preventive controls
and this is really to preventenvironmental pathogens from
getting onto products from afood facility.
And then they've got somethingcalled supply chain preventive
(24:22):
controls, which are what you putin place if somebody else along
your supply chain is going tocontrol a hazard for you.
So it really builds out thisvery comprehensive food safety
program.
It also requires everybodyfalling under the preventive
control rule for human food havea really comprehensive recall
(24:42):
plan to make sure that thoseproducts can be recalled
appropriately if there is needfor a recall.
So it really does build out avery, very comprehensive food
safety plan for those within themanufacturing sector.
Speaker 2 (24:59):
And I think we're down to the last rule and, if
I'm not mistaken, is that onethat is related to importers.
And you know we were talkingbefore as we're going down
through the, through the rules,the foreign supply verification
program, but is there, is thatlast rule related to that?
Speaker 3 (25:24):
Yeah, so the voluntary qualified importer
program is really linked backinto that foreign supplier
verification program that wetalked about above, and what it
is is a fee-based program sothat foreign food facilities
that intend to import theirproducts to this company can
(25:45):
become registered and verified,so that it really speeds up a
process of inspection andevaluation of their products
coming into the US, whether theybe for food or animal
consumption coming into the US,whether they be for food or
animal consumption.
Speaker 2 (26:04):
Okay, so, michelle, you've shared some, I mean a
really good summary of theseseven rules, but one thing that
I was hoping maybe we can, youknow, discuss in the time that
we have left.
I understand that there aremore, if not new, proposed
regulations.
If ESMA has some newregulations, can you maybe give
(26:27):
us a little bit of a summary oroversight of what that is?
Speaker 3 (26:32):
Yeah, there are a number of them out there.
Probably the one that thelisteners to this might have
heard the most about is the, thefood traceability program.
You know, and I think I think Italked a little bit when we
talked about the preventivecontrol rule, about recalls I
think traceability is a hugeissue within within food in
(26:56):
general and I think especiallywithin within produce, where
we've got perishable commodities, um, one of the one of the
things that that rule that ruleis really sort of bringing
itself together to do, is reallyhelp people or require people
to have very good traceabilityum of of their products.
And so Frankie Honest, who's adeputy commissioner over at FDA,
(27:21):
used to work at Walmart beforehe moved over to FDA, and a
story that he's fond of tellingis that one day he asked his
team at Walmart to tell himwhere the mangoes in his package
of fresh cut mangoes came from.
And I won't, I won't tell youthe whole story, but, okay,
needless to say, they couldn'tdo it very well or very easily,
(27:43):
right?
And and I think that's truewith a lot of fresh produce,
right, we have co-mingling, yeah, label each individual produce
item, and so really, whatthey're working on in this
traceability rule is to come upwith a better way to be able to
better be able to do trace backand accountability when we've
(28:03):
got a food safety issue, and Ido think that's a really great,
great thing for it.
Speaker 2 (28:09):
I certainly do want to know.
You know where my mangoes camefrom.
That's a good story.
I'm actually now curious ofwhat the full story is, but you
know, I certainly think that ourfarmers are going to benefit
from.
You know some of theinformation, or all of the
information that you've sharedwith us today.
(28:30):
Is there things that yourecommend to our listeners when
it comes to these rules and thetopics that we've covered today
and how to find out more?
Speaker 3 (28:42):
Yeah, I mean, I think the number one thing to do is
just do your best to stayinformed and I think, whether
that's working likeorganizations with fog or
reaching out to folks atextension at the universities,
find a way to stay engaged inthe rule.
And I think one of the ways todo that is to engage with FDA.
(29:03):
They have a community listservthat if you do email, you can
sign up for, and they willprobably more often than anyone
wants to send you an email aboutdifferent updates that are
going on in these differentrules.
If you're wondering or curiousabout which of those rules might
affect you, again reaching outto University Extension or FOG
(29:25):
or to FDA as well, there'sdecision trees available on the
website to help see if a ruleapplies to you.
And, yeah, just asking out andasking us for help, we do try to
keep folks as up-to-date aspossible when new rule
information come out, whenthings change.
I mean, like we mentioned atthe very beginning, a lot of
(29:47):
these rules are very, very new.
Implementation and inspectionsare in their very early days,
and so we're seeing evolution ofthem all as folks get more
comfortable with them and wefigure out how to make them work
on all different types ofoperations.
So I think keeping in touch,keeping up to date, doing what
you can, listening to podcastslike this, listening to other
(30:11):
educational content, is great,and then reaching out as much as
you need with specializedquestions about your individual
operations is always encouraged.
Speaker 2 (30:22):
Yeah, and we certainly appreciate experts
like you taking the time to talkto us and to our farmers, our
listeners.
We really, really appreciatethe time you've spent today with
us to clarify and provideinformation about the FDA and
the food safety monitoringsection at Rules.
Michelle, thank you so much.
(30:43):
Yeah, my pleasure, and weinvite everyone to continue to
tune in to our future episodes.
We'll go over more informationto help you understand food
safety.
Don't forget to check ourwebsite for new podcast episodes
and updates and upcomingwebinars.
Please also check us out.
(31:05):
Sign up to receive updatesthrough our mailing list and
feel free to also submitquestions on our website.
Thank you so much.
Speaker 1 (31:17):
Thank you for tuning in.
Visit our Food Safety forFarmers podcast page on our
website, wwwfoginfoorg, to findmore information about episodes
and webinars.
Subscribe to our email list forupdates and submit any
questions you may have aboutfood safety.
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