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FSMA Produce Safety Exemptions and Guidance: What You Need to Know for 2019


2019 small farms webinar series hosted
by a very simple my extensions local food systems small firms team
my name is Graham McCarty I’m only the local food systems and small farms
educators housed in Jeff Davis Stevenson and Winnebago counties we appreciate you
joining us for these webinars we will do our best to begin and end within the
space of your lunch hour this is a pretty tight time frame for educators to
deliver in depth actual information so please understand what we are eliminate
your questions to text box if you left during the presentation I will do my
best to make sure our presenters answer them as time allows so as you all know
this presentation will be recorded and Zach will email link to the archived
presentation as soon as possible after this concludes there will also be a link
for very short online evaluation of this presentation and we very much appreciate
your feedback for this this week’s presentation from Zach grant who you’ve
heard from last couple of weeks and he is one of our my fellow local foods and
small farms Extension educators stationed in Cook County
Zach has a BS and agribusiness horticulture from Illinois State
University and a master’s in horticulture from the University of
Illinois urbana-champaign from 2008 to 2015
Zach was the manager and director sustainable student farm at the
University of Illinois a work in small farm laboratory located on fruit
research farm at UIUC the farm specialized in year-round vegetable
production campus also conducted research education and outreach from
2014 until today the student farm has participated in the USDA gap G H P audit
program in 2015 he became the local food systems small farms educator focusing on
urban food production systems programming for a diverse group
stakeholders Zach is also one of Illinois eyes lead trainers for the
produce safety alliances produce safety ruling training for the Food Safety
Modernization Act with that take it away as act all right thanks a lot grant for
the great introduction and it’s great to be here with everyone today not as a
mater but as a presenter so as grant alluded
to part of my work at the statewide level is to is to conduct food safety
training related to the Food Safety Modernization Act and we do this in
collaboration with Cornell University and the produce safety alliance so the
produce safety alliance with Cornell has a cooperative agreement with the FDA to
disseminate training around the produce safety rule in particular and there are
a few other cooperative agreements throughout the United States but this is
the main one this is the main grower training that we’re asking all produce
growers to participate in to be in compliance with at least part of the
rule for FISMA so I’ll show you some resources for the proto Safety Alliance
and where you can look to for future trainings that we actually conduct so
this presentation today is gonna solely focus on FISMA produce safety rule
exemptions and some guidance surrounding that when we do the full day trainings
for the produce safety rule with PSA we often don’t spend a lot of time talking
about who legally has to comply with the federal rule and what these exemptions
actually involve and who can actually get them we do cover it but we don’t
spend a great amount of time so this slide set was actually developed by the
produce safety Alliance to kind of address those particular concerns and
then I also threw in a few of my own slides to talk a little bit about
questions we often get surrounding hydroponics aquaponics operations sort
of non soil based operations mm-hmm and what we’re gonna do is kind of go over
the exemptions what they mean what they look like and some definitions and then
we’ll go through a variety of scenarios and quizzes to kind of get you aligned
with you know potentially what your operation is and if you have to comply
with the Food Safety Modernization Act and then we’ll look at some recent FDA
FDA announcements and updates and a few other sort of 2019 pertinent things so
2019 marks the first year that that inspections by FDA auditors or if you
were in a state that has a cooperative agreement the FDA a state potential
State Department of Ag inspector could come to a produce operation
and see if a farm is in compliance with the produce safety rule so this won’t
apply to all farms will likely start off with very very large farms and will will
kind of get into that a little bit throughout the presentation but but the
produce safety rule is here and it’s actively being enforced so I think it’s
important to highlight the exemptions and highlight guidance and things that
you need to know as a farm moving forward so we’ll go ahead and get
started so for those of you who don’t know what the Food Safety Modernization
Act this was actually passed into law on January 4th of 2011 by President Obama
it was actually the most sweeping reform of u.s. food safety laws in over 70
years and in fact farms produce farms had never been subjected to federal
regulation of any kind and the produce safety rule is only one part of seven
parts of the Food Safety Modernization Act so our training my expertise and
guidance in this webinar today is only really focused on produce safety rule
and it kind of lightly overlaps a little bit with preventative controls rule for
human food the PC rule is what we call that but there’s a completely separate
Alliance that deals with that and that that’s actually more for food
manufacturing food processing and in particular for larger operations people
often have the question of does preventative controls at the federal
level overlap with Illinois cottage food law that we had a webinar about a few
weeks ago and my current understanding that it does not cottage food operations
would not be considered facilities and therefore not regulated at the federal
level under the PC rule but there are some larger farms that are called mixed
type facilities that would potentially have to overlap with both produce safety
rule and preventative controls rule and what you’ll see that in a little bit and
in fact that flowchart that I sent in the email to everyone kind of elucidates
that distinction a little bit more clearly but this this training and my
expertise in this webinar is mainly revolving around the produce safety rule
and again this this is all focused on prevention this is not you know meant to
kind of force farmers into farming in a sterile environment this is all about
risk mitigation elimination so I just I just wanted to
kind of throw that out there and additionally you know I as an extension
agent have a very neutral position about this what I don’t want to get into any
sweeping debate about you know federal overreach in terms of you know what this
rule actually means so we can have that conversation at a different different
time if you have questions related to that but the produce safety rule is here
and and I just want to make everyone I just want to make sure everyone is on
the same page that they know if they have to comply or not so when we do the
full day training we cover all these critical control points or potential
contamination sources in fact there are seven modules and we cover six of them
in depth here with all of these or five of them human health and hygiene soil
amendments wildlife and animal intrusion water is a big section and then
obviously post-harvest and equipment handling so we’re not gonna dive into
the details of that that is what the full day training is for and if you are
interested in the full day training the next slide will show you the Purdue
safety lines website where you can go to learn about some of our upcoming
trainings and we do have a few of them coming up both this spring and then
again in the fall for those of you who need to take the training or or want to
take the training so we will talk a little bit about water a little bit
later on but again this this webinar is not meant to go into depth in any of
these particular areas that’s what the full-day training is for so here is just
a quick screen shot of what the produce safety Alliance website looks like so in
any search engine just go ahead and type in produce safety Alliance Cornell and
you will find this website and this is probably the best catch-all resource for
information surrounding the produce safety rule as part of FISMA so here you
can find where the trainings are you could there’s that there’s a list of
trainings throughout the entire United States as well as other resources news
updates related to this so if you want to find out where the the newest
information is you know you can you can always contact me but you know this is a
direct go-to source there’s even a great listserv a newsletter and and monthly
call sign in sheet that you can get on so you can stay up to date with
the latest and greatest when it comes to the produce safety rule so I just wanted
to show everyone that so you know where to go to look for our full trainings if
you’re interested in in signing up for one of those okay so with that we’re
gonna just jump right in to the material so the big question that people have
surrounding the produce safety rule part of FISMA is is my farm exempt or am i
excluded from the federal legislation okay and that’s an important distinction
the federal legislation because at the state level or the buyer private private
buyer level there may be some other things you want to adhere to and we’ll
talk about that in a little bit but with FISMA in particular there are some
exclusions and exemptions so growers may be excluded based on if they’re growing
the type of commodity they’re growing if it’s a if it’s considered a rarely
consumed raw item by the FDA then that would exclude you if you’re exclusively
growing that and we’ll see that in a second the average annual produce sales
so the size of your business that’s that’s an important distinction that
will elucidate in a little bit personal on-farm consumption so there was a lot
of fear surrounding FISMA and when this was first being discussed and legislated
that you know the the federal government was coming in and preventing you from
growing your own produce at your own on your own property that’s absolutely not
true and so personal on-farm consumption this has FISMA has nothing to do with
that at all you can do whatever you want in terms of growing food if you’re if
you’re you know eating it yourself or you know with your keeping it kind of
within your family now some growers may also be exempt based on processing
activities or commercial processing after they’re they’re one step forward
to the bar that they’re selling it to them we’ll discuss that in a little
detail and then the one thing that everyone wants to know about is the
qualified exemption based on average annual food sales to qualified end-users
and we’re gonna discuss that in great detail because that’s that’s the real
crux of what people want to understand is can I have a qualified exemption to
the produce safety rule and hopefully you’ll understand that by that the end
of this webinar but ultimately I want to point out that all growers should
understand and take action to reduce food safety risk on
on the farm so this is my soapbox sort of Smokey the Bear only you can prevent
forest fires moment so even if you’re exempt from this rule you should I
encourage you to have some level of food safety planning or food safety systems
built into your operation and understand some of these basic concepts so you can
prevent you know foodborne illness outbreaks and getting people sick
frankly so we encourage you to take our training that we do in collaboration
with the produce safety lines yes it costs money but some of them moving
forward are gonna be more expensive than others in fact we have a couple
subsidized trainings coming up from some outside funding so we encourage everyone
to take it you learn basic good agricultural practices as well as how
that ties in to the actual federal legislation itself okay so you know this
slide is just kind of showing you within the federal register you know the
different parts of the register you can you know go to the the food safety
website or I’m sorry the produce safety lands website and look at the actual
federal register the unique thing about arche this training we do with the proto
safety lines is that it ties you know the good AG practices that we’ve done in
older food safety trainings but this ties it directly to the federal
legislation so we have you know tables and charts and the actual letter of the
law if you will in the binders for the training and it cross references it so
every time we come to a section of you know some sort of practice that you
should be doing or you must be doing it ties it directly to the federal
legislation in the binder so it’s kind of unique unique in that sense and
that’s what really separates it from other food safety trainings you may have
taken or with us or with other organizations in the past so let’s talk
about the exclusions based on average annual produce sales and the produce
definition that’s within the produce safety rule so the basic sort of low
cutoff for farms is the $25,000 previous three-year rolling average so of course
this is an adjusted for inflation so if you look in 2018 with the three-year
rolling average inflation adjusted that would be closer to 27,000
in 2018 so so as it stands in 2019 it’ll go up a little bit but for 2018 if you
are selling less than twenty seven thousand dollars worth of produce or 26
thousand nine hundred ninety nine dollars then the produce safety rule
does not apply to your operation okay so that’s that’s the first level of with
engine you might be able to qualify for and in terms of produce what they
actually mean it’s it’s written here so any fruit or vegetable including mixes
of intact fruits and vegetables includes mushrooms sprouts irrespective of seed
source peanuts tree nuts and herbs and we’ll mention sprouts in a little bit
but sprouts is actually there’s another level of complication with sprouts
because there’s there’s a higher level higher risk level with sprouts at least
as the FDA sees it and there’s a few other things you need to know about that
we’re not gonna cover that today and that’s in fact a completely separate
training but it is important to distinguish I guess I’ll do it here the
difference between sprouts and microgreens for any of us on the call
who are doing commercial microgreen production the FDA does recognize the
difference between sprouts and microgreens but they do consider
microgreens produce or vegetable if you will and it has to comply with all the
other parts of the produce safety rule so covered produce is another definition
again the fruits and vegetable produce definition from the previous slide so
you might hear this term RAC or agricultural commodity so this includes
both domestically and imported product obviously most of us in the in the small
farm world what we’re mainly thinking about domestically and in fact very
locally and and and regionally this is what we’re talking about with covered
produce now with embedded within this they actually have somewhat of an
exhaustive list of what the FDA considers to be rarely consumed raw
produce so if you’re growing if you’re opera if your entire business operation
revolves around one of these 34 items or a combination of these 34 items then if
you’re exclusively growing these things and that’s it
then then you actually would have an exclusion or exemption from the produce
safety rule because the FDA considers this not covered produce because they
consider it rarely consumed raw now we could have a debate about this you know
there are some things that cross over a little bit which is strange things like
garden beets which I yes I understand and and they consider both roots and
tops which some people do eat garden beets raw they are mainly cooked
primarily before they’re consumed but some people do consume them raw you know
you can make the same argument with with sweet corn and maybe a few other things
on this list but at least from the FDA’s perspective this is a rarely exhaustive
list of things that they consider rarely consumed raw and therefore aren’t
covered produce with the definition from the previous slide and your farm
wouldn’t have to adhere to the produce safety rule now that being said if you
are growing some of these items right so for instance a produce farmer very
likely could be growing winter squash eggplants garden beets sweet corn but
now likelihood you are growing a number of other produce items that are covered
under the produce safety rule so if your systems are all intermingled and you
don’t have a way to separate that those the production of those things in your
systems from probably seed all the way to post harvest storing and and shipment
then then that’s going to be difficult for you to justify that but it’s just
important to understand this rarely consume raw less because it does exist
so again we covered the personal on-farm exclusion or exemption so anything that
you’re growing for personal use or for your family on the on the farm or
another farm under the same management is not covered so if you’re eating this
yourself for your own personal family household consumption then it’s not
covered under the produce safety rule so the other distinction here that we need
to talk about is the rarely consumed raw or I’m sorry the raw agricultural
commodities or racks that we just defined a moment ago from non racks so
PS are this particular produce safety rule that we’re discussing here does not
cover things like sliced apples you know cut green beans that are frozen or other
processed items those things if you are defined as a
facility and you know you’re doing larger scale commercial processing that
would be covered under the preventative controls rule for human food and not
under the produce safety rule so it’s an important distinction between racks and
things that are not raw or cultural commodities so there’s also covered
activities during harvest so this is something that these are things that
won’t trigger the facility definition that the FDA has and and would be
considered as part of the primary production farm definition so these are
things you can actually do that wouldn’t trigger the facility definition and
therefore you’d have to adhere with the preventative controls rule so this keeps
you within the produce safety rule in other words so things like you know
washing you know the actual harvesting Act trimming outer leaves shellene you
know of a variety of things and activities that are affiliated with the
actual harvest and then there will be some things post harvests as well so if
you’re concerned about whether you know washing or packing makes you a facility
rather than a farm it doesn’t those are actually covered
activities and you would still be considered a farm and not an actual
facility so there are a few other processes that would actually also be
considered covered activities under a primary production farm and not trigger
the facility definition so some of these they consider these sort of low risks
manufacturing or or food processing so things like dehydrating or drying
treating for ripening okay so this is the case for larger tomato growers who
might be ripe ethylene ripening green tomatoes into red tomatoes for shipment
and then packaging and labeling so these activities are you’re still considered a
farm and it doesn’t trigger the facility’s definition okay so there’s
both harvesting activities and then even some processing activities outlined here
that still make you fall under the farm definition and and will not trigger you
to become a facility which is a with just the preventative controls rule and
it’s a whole whole different ballgame if you have to adhere
to that other part of FISMA so it’s an important distinction to make so
commercial processing is another exemption that you may actually have
okay so this would be the case so the best example I can think of as if you
are a large tomato processor or tomato sauce tomato grower that sells directly
to a processor that would you know convert that into something like ketchup
or canned tomatoes okay so if you if you are solely doing that and you have that
specific documentation trail and written assurances between you and the buyer of
your item that’s going to process that material right so validated canning
processes or other validated kill step processes if you have that written
assurance and documentation from your buyer then and that’s all you do that’s
all you’re selling and growing then you would have an exemption via this
commercial processing portion of the PSR okay so that’s an important distinction
to make now if you’re doing this but you’re still selling other raw
agricultural commodities that aren’t being processed then this would still
apply this would only apply if this is all you’re doing so the best example I
can think of is if you’re a sauce tomato grower and and that’s all you do okay
but again there’s still specific documentation and written assurances
that you must have in place in order for this exemption to actually apply now we
get to the the real interest with exemptions and this is the qualified
exemption and qualified end user definition for those of you who have
been following the legislation this was also known as the tester amendment so
John tester and another member of Congress actually submitted this as an
amendment to protect you know essentially smaller farmers so kind of
the audience that we have here with the webinar series so this is this is what
you really need to want have you understand what the qualified exemption
means what qualified end-users are in order to see if your operation actually
falls under that and and it on the surface it seems pretty straightforward
but there is nuance with this and as we go through this quiz a series of quizzes
here in a second you will see some of this nuance
and in in my mind this is a bare minimum a reason why you should at least take
the training with us to understand all of these different potential
contamination pathways a little bit better because you may think that you
have a qualified exemption right now as it currently stands but you you might
see how either as your farm expands or through kind of a technicality with
these definitions you may actually have to be in compliance with PSR so let’s go
over this in a kind of a slow stepwise fashion so you really understand this so
for the qualified exemption the first thing that you have to have compliance
with is that during the previous three-year period okay more than half of
the average annual monetary value of the food okay then that’s important to know
so this is not just produce this is if you are selling meat if you are selling
grain if you are selling jams pickled products any popcorn in an agribusiness
setting that qualifies this food okay it’s not just produce I know this is
this is contentious and there’s probably we get lots of questions and
frustrations with this but as it’s currently written the FDA has it set up
so this is food all food not just produce so let me step back more than
half of the average in your monetary value of all the food the farm sold was
directly to qualified end users and we’ll define that in a second well well I guess we’ll go ahead and
define it right away so the qualified end user is either the consumer of the
food and the consumer does not include a business or a restaurant or retail
establishment that is located in the same state or same Indian Reservation as
the farm that produced the food or not more than 275 miles from such farm so
some of the things that fit under both a consumer of food and the retail food
establishment would be things like roadside farm stands meal kit services
if you were selling to a meal kit service grocery stores convenience
stores farmers markets as well as the consumer of food would be a CSA
participant as well or some other subscribe
in service so it’s it’s it’s you as the farmer directly selling food to the
end-user there cannot be any middle person between you and the end product
so if you’re selling directly to a grocery store that sells it to an end
user that’s fine but if you’re selling it to a produce broker or some sort of
distributor and then they turn around and sell that to a grocery store then
that would not qualify as a qualified end user okay so that’s the first thing
that you have to adhere to the second part is that the average annual value of
all the food remember not just the produce all food on the farm sold during
the three year period so this is an average the three year rolling average
was less than $500,000 okay so this is also adjusted for inflation and if you
took the three year inflation for 2018 it would actually be significantly
higher around a five hundred and thirty nine thousand dollars so 50% or more of
your food is to the qualified end-user and your aren’t selling more than five
hundred and thirty nine thousand dollars in 2018 then you can have then you have
qualified exemption okay that doesn’t mean that you’re completely off the hook
we’ll look at a couple things in a little bit but one of the things that
absolutely means is that in order to establish this qualified exemption if
the FDA or your state regulator wanted to know this you have to keep records of
your food sales so I know that seems like duh right most we are keeping track
of our as a business we are keeping track of our food sales but it’s
important to understand that you know it’s not just produce it’s all food for
your operation and you need to keep track of those sales and have records of
those sales to be able to prove that you are under this $539,000 threshold okay
so it’s important that’s that’s the first record that you should have to
have even if you are going to be qualified exempt so let’s go over a
scenario that was actually submitted to the FDA’s tan which is or although it’s
called the technical assistance Network so those of us doing produce safety
training or just you know citizens can submit questions about the produce
safety rule to the FDA tan and this is a question that was
submitted that I flagged because I thought it was what’s quite interesting
and might be you know analogous to some of your situations out there so let’s go
over this a little bit and figure out this scenario so it’s a produce grower
who sells more than twenty five thousand dollars over the three year average okay
so that would be adjusted for inflation in twenty eighteen twenty six nine nine
nine but less than five hundred thousand okay five thirty nine for inflation
adjusted in all food over that three-year average and in this case this
grower just is producing vegetables they’re not selling any other
value-added or grains or meats or anything like that the grower also sells
within the same state and within two hundred and seventy five miles of where
the produce grown okay so it’s sounding good so far right
forty percent of this grower sales are through local farmers market so the
direct end-user definition right sixty percent of the total food sales go
through a local food hub this local food hub is also within two hundred and
seventy five miles of the same state as where the produce is grown this
particular food hub is an aggregator of raw agricultural commodities and does
not conduct any processing activities the hub handles many other farms produce
from the region and distributes to further markets many of which are not
direct consumers in this scenario with the food hub be considered a qualified
end-user or not and would this grower satisfy for the requirements of the
qualified exemption that we just discussed so if you want to go ahead and
and and put that in the chat box you can because I’m gonna ask you to do that for
a few other quizzes we’re gonna have here in a second so does this grow or
satisfy the requirements for the qualified exemption as I’ve just
explained it to you in the previous slide so I’ll just give you a couple
seconds and then we’ll skip to the next slide if you think that this applies so
just a couple seconds and then I’m going to move on to the next slide if no one
answers so Dawn says no 60% is not sold to the
end-user okay Vanessa says no they’re both right so according to the FDA in
response to this particular situation they’re saying that the food hub does
not meet the definition of a qualified end-user therefore a grower farm is not
eligible for the qualified exemption because 60% of the sales were to this
non qualified end-user now they recognize that some food hubs
have different business models like that operate more like a grocery store right
or even a restaurant but in this case the way that this grower was describing
the food hub this sounds like distributing to further markets this
sounds like a middle distributor or a produce broker so therefore they would
not qualify as either a retail food establishment or an end-user so I wanted
just to kind of point this out because I think you know this scenario probably
isn’t too far off for a lot of us on the call right I mean I know a lot of farms
who are probably under that $500,000 threshold but are you know looking to do
a little bit more wholesaling and maybe even sell through food hubs and some of
these other cooperative agreements so you you have to make sure that you you
are selling directly to a qualified end-user or who you’re selling to is
signed to a qualified end-user or is that that qualified end-user so I know
there’s a lot of nuance here and maybe even this is making it more confusing
for some of you but it’s just important to kind of really understand the
definition of the qualified end-user and the qualified exemption so what we’ll
view we have four or five questions here and this will maybe kind of help you
know make it a little bit simpler for for everyone on the call and go ahead
and in the chat box go ahead and type in you know yes no or you’re not sure A B
or C you can put it in there and then we’ll kind of discuss each question so
the first quiz will be a farm sells $19,000 in produce average over a
three-year period at a local farmers market and through a CSA is this farm
covered by the produce safety rule part of FSMA so most of you are chiming in
no no B no no no you’re absolutely correct in this case no you would not be
covered because it’s less than $25,000 or 26 nine nine
nine inflation-adjusted so in this scenario if this describes
your farm then then you would not be covered under the produce safety rule
excellent so quiz number two a farm sells thirty
five thousand six hundred dollars in produce and also sells six hundred and
fifty thousand dollars and other food products including sauerkraut and jam on
a three-year rolling average do they satisfy the qualified exemption
requirements as described previously okay a couple people said no so we’re
getting a lot of nos a lot of nos alright we’re two for two no this would
not qualify because since the farm is more than 25 thousand dollars an average
annual produce they would not be covered and they also do not qualify for the
qualified exemption since they sell over five hundred thousand dollars in other
food products so this is where it kind of starts to get tricky and I know that
a lot of agribusiness I’m sorry a lot of Agri tourism operations might fit under
this sort of definition where they might sell a small amount of actual raw
agricultural commodity but they do a lot of other food value-added sales for
their Agri tourism operation so this would probably describe a situation like
that and in this case that farm would not satisfy the qualified exemption so
quiz number three a farm sells four hundred and seventy five thousand
dollars in produce on a three-year rolling average two hundred thousand
dollars of that is the wholesale or out-of-state more than 275 miles two
hundred thousand to a local restaurant and seventy-five thousand dollars to a
local grocery store do they satisfy requirements for a qualified exemption
in this scenario so let’s wait a couple seconds see if we can get some answers
in the chat box okay we’ve got some nose nose nose one yes so we’ve got some
different opinions on this one let’s see what the answer is the answer is yes
they do they likely will be eligible for a qualified exemption because the sales
to the qualified end-users so the local restaurant and grocery store
exceed the wholesale sales of $200,000 to the oddest wholesaler out of state
and all sales are less than that $500,000 rolling average so in this case
this situation this farm would qualified exemption okay hopefully this is
becoming a little bit clearer so we’ll do one more and then we’ll do a final
exam at the very end here a farm sells all of their twenty eight thousand
dollars in produce annually to a distributor located more than 275 miles
away and not in the same state of where the produce is grown the farm grows
potatoes pumpkins sweet corn winter squash and has one acre of raspberries
and strawberries is this farm covered by the produce safety rule yes no or I’m
not sure what do you what do you all think okay so we’ve got one yet no
they’re not covered by the produce safety rule yes they are covered no
they’re not covered so again some a little bit more confusion so in this
scenario and and we could ask a few questions from this particular quiz
question in this scenario this farm would be covered yes because raspberries
and strawberries are covered produce and the total produce grown is above twenty
five thousand dollars in total produce includes with the strawberries and
raspberries I’m sorry it includes rarely consumed raw commodities okay so do they
satisfy the qualified exemption no because they grow less than five hundred
thousand dollars in food but they’re selling all of their produce more than
50% of the total to a distributor that’s out of state or more than 275 miles from
where the produce is grown this does not make this buyer a qualified end-user and
therefore this farm were not satisfied the qualified exemption but you could
ask the question what if they sold all this produce within the 275 miles from
where the produce was grown would they satisfy the qualified exemption then and
I think the answer to that would be maybe it would depend on if
over half of their sales work to buyers that fit the qualified end-user
description and you know they are under the $500,000 so part of its required but
that qualified end-user is an important piece so this just illustrates why it’s
not quite as straightforward the the two requirements that we highlighted a few
slides ago are pretty straightforward but you really need to analyze your
total sales your end users and where you’re selling this product to really
figure out if your operation falls under this qualified exemption okay so I
mentioned already that if you do have a qualified exemption that you have to
keep records to be able to prove that but there are a couple other things that
you have to adhere to and these are what they call the modified requirements if
for a qualified exemption so if you have a qualified exemption you still must
follow a couple things and these are important for traceability so if you are
doing any sort of food packaging or food packaging is required so I guess the
best example I can think of for that would be is if you’re selling your herbs
or your salad greens your head lettuce and clamshells for instance under the
the Food Drug and Cosmetic Act the federal level you technically have to
label those items you have to label what it is what it weighs in the description
of the product and on that you would also have to include the name and
complete business address of where the produce was grown so in that scenario
you still have to you know label your if you have to label your product you have
to let people know who you are and how they can get ahold of you now if you’re
not labeling any product like in the case of if you’re in if you’re not doing
anything like I described in that scenario and you’re just selling racks
at a farmers market right then you have to display at the point of sale the name
and complete business address of where the produce is grown okay so and then if
you are selling via CSA is for instance then you you would have a direct link to
your end user so they should know how to get ahold of you anyway so there has to
be some connection between you and the end user in terms of how they can get
ahold of you even if you have this qualified exemption to the proto safety
rule okay this will be final exam question before we get into a
few other things to finish the presentation off okay so a grower is
eligible for the qualified exemption and is only subject to modified physical
requirements like we just described in the last slide however their buyer their
end-user buyer requires a food safety audit in order to accept them as a
supplier does this grower need to comply with these buyers requirements what’s
the answer to this is it yes/no or you don’t know go ahead and answer okay so
some people are saying yes some people are so we’ve got a couple yeses and the
answer to this question is absolutely yes so if you want to sow audits are not
required by the regulation but they’re required by some buyers or end-users so
if you want to sell the certain grocery stores or maybe even certain restaurants
they might actually require you to go through third party food safety
verification okay so what is that so you might have heard of GAAP audits are
different types of audits from you know the USDA AMS service Primus sqf there’s
a lot of third party independent food safety audit programs out there and the
best analogy I can make to this would be very similar to organic certification
Organic certification is not required but if you want to be able to market
your products as certified organic right and there’s even a certain monetary
threshold if it’s more than five hundred thousand five thousand dollars in
produce then you have to have independent third-party verification
that you’re following these practices the same thing happens in the produce
safety world so some end-users may require third party audits like GAAP or
prime minister or sqf there’s a few of them out there so this is voluntary this
is completely industry driven FISMA and the FDA is federally mandated law so
there’s a difference between the two okay now the the interesting thing is if
you’re interested in participating in your buyer requires third-party
verification a lot of these audit services are now aligning their audit
checklist with the produce safety rule so two
birds with one stone essentially and a good example of that would be the USDA’s
harmonized gap program their checklists for that third-party independent audit
service is also in alignment with the produce safety rule part afisma so if
you’re doing that audit then you should also be in compliance with the produce
safety on all those records and documents that you have for that plan
should help you if if an FDA inspector were to ever come to your operation okay
so I just wanted to recap you know there are exclusions and exemptions based on
types of commodities how much you’re selling and where you’re selling it to
the definition and your sales are really you know some of those definitions you
need to really understand those to figure out if you’re gonna be compliant
with PSR or not and I hope that this kind of helped clarify that a little bit
more now what I wanted to do for the rest of the presentation we have about
20 minutes left is just to kind of highlight some updates and some other
questions that we’ve had out there regarding you know certain parts of PSR
or FDA updates these next two slides deal with aquaponic and hydroponic
operations we get this question all the time particularly with my urban
agriculture stakeholders who participate in aquaponics and hydroponics operations
is how do these operations fit in with the produce a true part of FISMA now
there isn’t anything explicit about these types of systems in the rule
itself but in the preamble to FISMA the FDA went through a commenting period
where people submitted these questions and they they submitted their responses
so I kind of deal that a little bit and pulled out some of these salient points
so the FDA does recognize that the growing environments between hydroponics
and aquaponics differ from soil based systems however these systems are not
exempt from the produce safety rule so most of those routes of contamination
that we looked at in one of the earlier slides still apply to these operations
so yes there is no soil in these systems but the worker health and hygiene still
applies the water rules still apply the equipment cleaning and sanitation still
apply so most of those routes still apply okay so that’s important two
distinct justing so one other comment that was thrown out
there was that yeah fish don’t normally carry you coli Salmonella some of these
foodborne pathogens were concerned about and that is true in general but if there
is e coli contamination at high enough levels in water then fish could
potentially become carriers we’re different routes of contamination like
the feed and an aquaponic operation water or sediment that needs to be
filtered out of those particular operations and they also mentioned that
fish carry other potential human health pathogens like Vibrio species OSA that
that could be there’s not there isn’t a lot of data or they’re not throwing our
data out there but this is what the FDA recognized in their comments to these
questions okay the other interesting thing is that the
USDA gap third-party volunteer gap out in service they’re starting to certify
aquaponic and hydroponic operations and this is just kind of an overview of some
of the guidelines for their pilot program looking at aquaponic operations
in particular where they’re requiring a physical separation between the fish
aquaculture and the crop hydroponic area there they recommend filtration to get
out sediments and also are you know recommending treating the water as it’s
being recirculated through the system and they provide a number of different
options or examples like UV treatment chlorine ozone there’s a lot of
different options out there and they want you to have SOPs in place for tools
equipment employees you know water protective clothing and things like that
so all that being said aquaponic hydroponic operations this doesn’t get
you out of the water either for the federal FISMA PSR rule or for these
third-party GAAP audits because there are you know industry large industry
within aquaponics and hydroponics are starting to participate in these
programs so I just wanted to point that out so a few other announcements that
are relevant to 2019 in particular I want to cover these really quickly so
there’s two draft guidance documents for produce growers that might be relevant
to you that the FDA has recently put put out so these were published in the
Federal Register in the fall of 2018 and you
actually you know go and look at these things and submit comments to the FDA
until April 22nd of this year so the first one that applies to produce
growers is the standards for the growing harvesting packing and holding of
produce for human consumption so what a guidance document is is the FDA who is
enforcing the rules for PSR it’s their interpretation of the law so it should
follow you know everything that we cover when we do the big training and
everything I’ve said today but they might provide a little bit more guidance
and a little bit more specific information that might help you in your
operation so I encourage you if you’re interested in that to take just the go
you know any search engine and type in standards for growing harvesting packing
and holding produce FDA you’ll find it read through it and you can even submit
comments the second guide to minimizing food safety hazards a fresh-cut produce
actually applies more to mixed type facilities or farms that may be doing
some processing that isn’t covered that isn’t that we didn’t discuss in the
previous slide so this would be for more for facilities that are doing more
processing they have a guidance document out for that as well that you can also
look over and submit comments as well you’ll notice when you look at this the
first guidance document that I’m discussing the egg water one of the
critical control points that contamination routes is not included in
this guidance document and you’ll see why in a second and this is because of
all the parts of the produce safety rule everything is officially law and being
enforced right now except for the water portion of the rule and back in in
September of 2017 the FDA submitted an extension a potential extension for
water compliance and that’s because the the water rule surrounding the produce
safety rule is very is a little complicated and they want to have a
little gift growers a little bit more time and the FDA a little bit more time
to figure out how they’re gonna enforce this and provide better guidance for
growers when it comes to water sampling and and things like that okay so I or
the proto Safety Alliance hasn’t we haven’t officially heard that this is
actually law but this is a press release from Sept
2017 so farms that will be inspected this year they’ll be inspected an
enforcement will take place for all parts of the Purdue safety rule with the
exception of water compliance there’s there’s a bit of an extension with water
compliance and what that looks like is this so if you are a very small business
so above that 25 K threshold but up to a quarter million then the original
compliance date for your farm would be January of next year ok and then then in
the first rule you would had two additional years the way it was first
written to come in compliance with the water rule but now they’ve extended that
to an additional two years so you you actually won’t have to come into
compliance with subpart E the water portion of the rule until 2024 so and as
you go up depending on the size of your compliant business with the PSR those
are the dates so so right now you know this year and last year started in 2018
all the very large farms and some of the medium-sized farms have to be compliant
with PSR except for water okay and everyone has some some level of
extension as you can see here with with compliance for the water portion of it
so what does this mean in terms of collecting water sampling and this this
can get very very nuanced and I’m just gonna just breeze over this quickly
because there’s a lot of confusion with this does this mean that you need to
have your water compliance by the time 2022 rolls around in for instance for
the very large farms no but that what we think it means is that you don’t have to
technically start testing your water and developing what we call a microbial
water quality profile for your production water and your post-service
water until that compliance date so this slide just kind of illustrates a
flowchart of how you might approach that because we would can we would encourage
growers to start sampling their water sources now with one of these equivalent
testing methods we’ll cover here in a second you don’t technically need to
until your compliance state for your size farm but we’d encourage you to
start beginning familiar with water testing now and developing some part of
your quality profile so when your compliance
they does roll around your you have those records for an inspector if they
were to come to your operation okay so again there is extension with
the water portion of the rule but you should continue testing water if you’re
doing it um and if you haven’t started doing that we would encourage you to do
it okay now for egg water or the production waters or things for like
irrigation crop sprays that type of water testing has to be a quantitative
form of testing so it can’t be pass/fail or qualitative testing like you do for
your home well for instance like for for fecal coliforms it’s those are usually
pass or fail in in for the production water you actually have to quantify how
much but generic e-coli you have in your water that’s the standard that they’re
using for for the PSR rule is gin quantitative generic Ecolab so you know
reach out to a lab you’re working with we have some labs we can recommend and
and and begin doing your water testing as soon as possible for your operation
so one of the things that they updated last year to were these water testing
equivalent methodologies so they do recognize present absence or pass/fail
methods for post-harvest water so this is water that we’re using after harvest
for washing produce for instance or washing our hands or cleaning and
sanitizing our tables this water has a strict requirement they want zero
generic e.coli in that particular water so if you if you are testing that type
of water for generic e.coli you can do pass/fail for that type of test because
you have to have zero generic e.coli anyway but for the production water you
can’t actually have a certain level of generic e.coli in your water and they
want you to quantify that so for your irrigation water crop sprays things like
that you actually want to do a different test for that and they have a number of
equivalencies to the original method that they published in in the rule and
the original methodology was this modified mtech this top one you see it’s
called EPA method 1603 they do recognize a number of other methods
they site here so you would need to contact your lab and make sure that they
they follow at least one of these equivalent methods now the frustrating
part with this is that the quantitative methodology actually requires you
according to the modified mtucker method 1603 to take a water sample and
get it to the lab within six hours so this is frustrating because if you
aren’t close to a lab or you don’t have the ability to get your sample to a lab
within six hours that actually would violate the chain of custody and that
would technically not be a certifiable analysis of generic e.coli so this is
something we’re hoping the FDA gives us more guidance on and maybe part of the
reason why they’ve extended this guideline out for years with the
quantitative testing pass/fail testing you can actually submit the sample to
the lab within 30 hours so overnight shipping of qualitative water sample
would would be okay so again it is confusing I recommend checking out
either well first of all I can recommend taking the training with us and we’ll
cover this in greater detail with our all-day training but also you can visit
the produce safety alliances website and you can understand this a little bit
more they have some guidance documents on here in fact all these equivalent
methodologies they have a good reference sheet on the produce a few lines website
for you to look at so when you contact your lab that you’re gonna use you can
identify the proper testing that you need for water testing so the last thing
I want to briefly discuss is enforcement discretion so this is important because
routine inspections are beginning this spring for the very very large
operations there’ll be no enforcement of subpart E
which is the water part that we just went over in in brief other than for
sprouts I mentioned earlier that sprouts actually has a stricter water quality
test or water quality standard and in fact all the water for a true sprouting
operation has to have generic ecoli for the production or for post harvest there
can be no generic e.coli in the water and they also have a few other stringent
more stringent tests that they actually want you to go through if you’re growing
sprouts now again remember I said they recognized that microgreens are not
sprouts grown differently so microgreens would
not be lumped in with those more strict standards for sprouts so so 2019
enforcement’s beginning this year and you know the very large farms are going
to probably look to potentially be inspected by an FD Auditor so hopefully
the very very large operations will have all their ducks in a row with all the
parts except for the water portion of the produce safety rule okay
and also on if you sign up for the produce safety Alliance a monthly
newsletter in the February 2019 and I can email this to you too because I have
this on my computer they actually have a form that the FDA has submitted to the
public that from what I understand will be the checklist that they would use or
the auditing form that they use for their on-farm inspections for produce
safety rule and FISMA enforcement okay so if you want to get a copy of that and
look and see what that looks like and what specifically they’ll be looking for
I encourage you to go to the produce a felines website and download that or I
can send that to the group as well so you can kind of get a feel for for what
an auditor or an FDA inspector might be looking for so I the other point that I
want to clarify keep saying FDA or state inspector in the state of Illinois is
one of only four states that doesn’t have a cooperative agreement with the
FDA for enforcement so the other states that do have cooperative agreements they
actually the the federal government gave the states money to allow their their
state inspection teams like on the department their Department of
Agriculture to do these inspections so in many states it’ll be the state level
inspectors that will be enforcing FISMA but unfortunately in Illinois because we
do not have a cooperative agreement with the FDA
it will be the FDA coming in and inspecting farms okay so it’s I just
wanted to clarify that a little bit but this this form that the FDA is submitted
for these inspections will likely be the form they use if they do come to your
farm for one of these inspections okay so the kill step exemption this is
remember I was discussing discussing the written disclosure to the buyer or the
buyer assurance to the farm that they actually are using a validated
he’ll step if you’re looking for that commercial processing exemption so it
sounds like in 2019 according to the slide that the it will be at the FDA’s
discretion in terms of following that paper trail so you likely would have to
make still make written disclosure to the buyer that you have not processed
that product adequately but it doesn’t sound like buyer assurance back to the
grower will be required at least this year okay so if this fall’s if you’re
the type of farm that’s only going to be selling no commercial process so this
would apply to you and you can contact the produce safety Alliance or myself
for more detail surrounding that okay so that is the virtually the end here this
is actually a video if you just type in virtual farm inspection tour FDA in any
search engine this is actually a 38 minute video kind of giving you an
overview of what an inspector an inspection would look like for your farm
operation this is actually for a very large produce farm in the Central Valley
in California so it might not apply to your operation but it’ll still kind of
give you a feel for what it might look like if an FDA inspector comes to your
farm so I encourage you to check this video out if you want so with that we
have we do have a few minutes left so if you have any questions that you want to
type in the chat box I don’t think I saw mini typed in the chat box or mainly
mainly I didn’t so if there’s any questions you have we can go ahead and
answer those now and we can take as long as we need I mean if you need to get off
the call feel free to do so so I see this first question from dawn do food
sales include food you buy for resale and do not grow or produce like jams
also do food sales include food sold for immediate consumption on the farm like a
sandwich great question Don so I didn’t I didn’t mention this when I was giving
that description of food sales but yes any food that you buy to resale so if
you don’t have potatoes for instance for your farm stand and you buy that from a
grower down the street the that that resold produce would can be considered
under the food sales now the question about immediate
consumption foods like sandwiches I’m not
100% sure about that if those you know direct immediate consumption foods would
qualify under that food sales rule but I would operate under the assumption that
they would for the time being until I could either clarify that or the FDA
clarifies that a little bit more but I’m pretty sure it would so any food sales
whether it’s you know process items or ready-to-eat foods like in the case of
selling sandwiches maybe out like for an agritourism operation that that would be
included in that definition as well okay great question
any other questions while while we have everyone on the line here you know and
I’ll just remind everyone that again you know this this this is new this is the
first year of inspections I know there’s a lot of sort of fear surrounding FISMA
on the produce safety rule but you know I think at least based on my experience
with you know GAAP audits and doing voluntary food safety audits for farms
there is a lot of fear leading up to an inspector or an audit or coming to your
operation but you know as long as you have a good plan in place a food safety
plan and good systems in place then you know once you get that that first
inspection or first audit done you know a lot of the tension comes out of of you
know preparing for something like this so you know I think it’s good business
practice and in general to kind of plan food safety around your operation and it
should be something you’re doing for the life of your farm and not just kind of
preparing for an inspector to come and then you go back to you know non good
agricultural practices afterwards so you know I would encourage you to take one
of our trainings and like I said if you visit the produce safety Lions website
and filter via Illinois you’ll be able to see when we have some upcoming
trainings near your area so that takes us to the end of our hour again you know
I can hang on for a few more minutes if there’s any questions burning questions
you have related to this you can go ahead and type in the chat box otherwise
you can contact me and I’ll type my email address in here or most of you
have it anyway because I’ve been sending you most of
the email so there’s my email address so if you have any questions feel free to
shoot me a question otherwise thanks thanks for having me on today yes Zach
thanks for joining us today Zach great presentation got a lot of
good information out of it doesn’t look like anyone is typing in any questions
so I guess we’ll wrap up and if you have some burning prep questions you can
email Zach thank you everyone for joining us for this webinar today we got
a lot of good information that will help you in your small farm endeavors
hopefully even something you can put to and put in place yet this winter please
look for an email from Zach with a link to the archived webinar on the Illinois
local foods YouTube channel so it was a very short evaluation the webinar you
have just watched we do look at your feedback and use it and shaping our
future webinars so it’s very vitally important for you us to get these and
with that have a good rest of the day and a productive growing season in 2019
and join us next week for maximizing your production succession and campaign
planting with Lauri George

Reynold King

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