What is the On-Farm Readiness Review (OFRR)?
An educational tool to help operators assess readiness for alignment with the FSMA Produce Safety Rule, the OFRR looks and feels like a farm tour and is a cornerstone of effective education and outreach on the rule. Additionally, the OFRR is an opportunity for State and Extension staff to gain more exposure to local farm operations that may be unique to the region’s commodities and production practices.
What’s involved?
It’s an educational site visit to help operators understand and align their practices with the FSMA Produce Safety Rule.
- The goal is for the visit to lasts not longer than two hours.
- OFRRs should be conducted as close to harvest as possible.
- Two to three ODA and OSU Extension (optional) staff make up the review team.
- Engagement will be conversational — this is not an audit or inspection; rather it’s an educational visit.
- Reviewers follow a standardized decision tree to determine which parts of the rule apply to the operation. These are the only portions of the rule covered in the review.
- No photos or notes will be taken during the review – the OFRR process is confidential.
Credit: Stephen Ward (Cropped from original)
How do OFRRs benefit a farm?
OFRRs identify strengths and weaknesses in operations relative to the FSMA Produce Safety Rule requirements.
You’ll have the full attention of folks who know the rule inside and out.
- Get answers to operation-specific questions about the rule.
- See which aspects of the rule apply to your operation.
State and Extension staff may refer you to other resources to help with understanding and aligning with the rule.
Credit: Bob Rost
Who are the participants?
Oregon Department of Agriculture, OSU Extension and you!
- ODA staff and OSU Extension (optional) — you may already be acquainted with some of these folks.
- You — we ask that someone in a position of responsibility for food safety participate for the entire OFRR.
- Anyone else you would like – neighbor, lawyer, your agronomist, Soil and Water Conservation District staff, etc.
See a checklist and fill out this form for scheduling an OFRR for your farm. It includes a link to a decision-tree. The form asks for you to include: acreage of the farm, harvest period(s), produce crops grown, and activities conducted (growing, harvesting, packing/handling, other processing).
More about the Oregon Farm Food Safety team
In 2018, Oregon State University Food Safety Extension and Research Faculty teamed up with Oregon Department of Agriculture (ODA) to learn more about the On-Farm Readiness Review (OFRR) initiative, intended to provide assistance to Oregon farms that are covered under Food Safety Modernization Act (FMSA) Produce Safety Rule.
Extension and research food safety personnel from OSU (Jovana Kovacevic, Joy Waite-Cusic, Sara Runkel [former], Stuart Reitz, Luisa Santamaria) participated in OFRR training from May 15 to 17, 2018 along with food safety extension, FDA and state government representatives from Alaska, California, Indiana, Montana, and Washington.
Since then, the partnership between OSU and ODA has led to the creation of Oregon Farm Food Safety team. The team has actively been offering Produce Safety Alliance grower trainings and OFRRs to the produce industry in Oregon to bring awareness about the requirements under the FSMA Produce Safety Rule.
Transcript
Introduction
well it's a couple minutes after 11 so I think we'll go ahead and get started with the presentation this morning and I
just want to say uh good morning and thanks all for joining us today for the knafs July webinar and uh this webinar
we're excited today will feature a presentation and discussion about the on Farm Readiness review and this topic has
been identified as something that's of great interest to those in our region uh since fsma inspection is expected to
very different from an audit um which you know many of our Growers are used to having Audits and and many Growers have
never even been through an audit the on Farm Readiness review was developed to help Growers gauge their Readiness for
an inspection on their farm and the mission of neafs is to support the Outreach and education of Growers who
are affected by fsma especially small and medium-sized producers um and we do
that through collaboration and integration of national efforts like the on Farm Readiness review so we are
really thrilled today to have West Klein join us from Recker University to walk
us through this presentation and discussion of the on Farm Readiness review and there will be plenty of time
for questions and conversations at the end so um if you do have a question that comes up you can put it in the chat box
or hold it and we'll unmute everybody at the very end to to ask and have some discussion so with that I want to thank
you and I will turn the presentation over to Wes okay thank you
Elizabeth uh just to give you a little background Meredith and I coordinate the
on Farm Readiness View and and food safety training for Ruckers Cooperative
Extension and some people think that these are full-time jobs but in reality it's about 50% of each of our times so
we end up with essentially one FTE doing on Farm food safety I just want to give
you a background on what is and also how
the Readiness review was developed to give you a better appreciation of what
we've gone through uh just as a little refresher the food safety modernization
Act was signed into law in January of 2011 and the final rules that really
apply to Growers were published final rules were published in August and November of
2015 this has been a big sweeping ch change for FDA and how they operate and
they really change in philosophy they're looking at prevention of contaminate
contaminants and contamination so they're going through a big learning curve of how to work with
Growers since most FDA people are have not been on farms have very little
experience working with Agriculture and they mainly have inspected neutraceutical
plants uh and packing operations and not field situations so you really need to
keep that in mind as we go through this and why we've developed what we
Main Rules
have uh the main rules for a fsma or the produce safety rule which is what uh the
Readiness view was developed for and it's really only for the produce safety
rule but the other rules involved are the preventive controls for human food and that's
manufacturing and and separate packing operations prevented controls for animal
food accreditation of third-party Auditors and this is mainly for offshore
FDA is in the process of accrediting organizations right now to be able to do
inspections offshore because they don't have enough people to do it a foreign
supplier verification program again this is where FDA is putting the onus on
importers to verify that their offshore operations are meeting the same standards as the domestic suppliers
intentional alteration adulteration of rule and the sanitary Transportation
rule so these are the main parts for uh
Whats Covered
fsma what's covered raw agricultural Commodities and there are several crops
that are not covered this is only a partial list this is the list that really apply to the Northeast and
midatlantic so anything that's on this list is not covered by the rule also
food grains are not uh produce consumed on the farm and any processed product as
long as you can show that it's being processed and has a kill
step also the average annual value of of produce sold during the previous three
years is less than $25,000 doar this number increases based on inflation and
for instance the value in 2016 is
$6,950 FDA has a publication if you go on their website and it will list what
the different infl inflation factors inflation factors is for the different
uh uh rules and it's called fsma inflation adjusted cut off
so that's important for especially for extension to be aware uh for
Growers there's also the to qualified exemption if you have the average annual
Qualified Exemption
monetary value of food sold Not Just Produce but all food sold in the previous three years is less
of 500,000 again that number adjusts depending on uh inflation also it must
be direct sales to Consumers and it that can be through a rest restaurant a retail food
establishment as long as in the same state or Indian Reservation or within
275 miles of where it's grown and 51% of those sales must be
retail includes all food and that all food is critical because that includes
animal food that includes milk that essentially includes most things that you're producing on the farm or being
produced on the farm the comp liance States very small
operations which is 25,000 not more than 250,000 is January
2016 uh four years after 2016 excuse me small farms 250 to 500 it's three years
after 2016 and smaller Farms is two years which larger Farms is two years
which means it's into effect now uh there have been changes to for
instance the water standards we know that FDA is revisiting that so those
dates whether it's going to go into effect in two years or not we don't know for sure nor do we know exactly how
they're going to change it these are the main parts of the
Sprouts
produce rule agricultural water which I just mentioned biological soil amendments Sprouts I do want to say that
the onim read review does not cover Sprouts uh there's domestic and Wild
animals worker training health and hygiene equipment and tools so the
review will cover most of these things except for Sprouts how this came about was when FDA
was writing the final rules nasda which is the National Association of
Departments of Agriculture was in discussion with FDA explaining that Growers really do not understand what
FDA is going to do as far as inspection how they're stting to do it what's included so they were asking FD if there
was possible funding to support a program to help Growers get better ready
for inspection nasda along with four state Departments of Agriculture Oregon North
Carolina Michigan and Vermont wrote a proposal to FDA and it was
accepted so the partners involved in this again FDA is the funding agency
nasda is the organization that's handling the money and providing grants to other
individuals USDA AMS are providing uh guidance then the four Departments of
Agriculture Michigan Oregon Vermont North Carolina they all also ask for uh
universities to be involved in developing materials University of Florida extension
michig State Extension North Carolina Cooperative Extension and Ruckers
Cooperative Extension so this makes up the group that's been working on this for about the last two
OnFarm Readiness Review
years so what is the unarm Readiness review we're the philosophy is it's
education before regulation as I said FDA this is a change in mindset for them
but they do want to support support education they do want to bring Growers along before there's any type of real
inspection and enforcement and they're looking at they're going to gain value from the
learning from the industry and Regulators working together in a spirit of of uh cooperation and
partnership uh this has been interesting to work with with FDA on this is the
organization needs to make a lot of changes in how they been operating the objectives of the project
Objectives
are really to offer a voluntary pre-inspection Readiness review for covered Farms so this would be before
there's any type of enforcement or real inspection taking place promote cooperation between
farmers regulators and Educators which is really something new uh there's been
very little cooperation among the three working together and we're trying to develop that
philosophy educ Regulators about on Farm conditions as I said
before FDA has very little experience working directly with Growers and this
is the reason that we got involved because we want to train regulators and
inspectors how you work on a farm what you need to consider and we'll go into more of that in a little
bit also if I identify any educational needs there's a lot of information out
there on what you need to do for food safety for for fsma what we're looking
at is identifying any gaps that may exist not saying we're going to develop materials but to identify them so other
people may de uh develop them also to familiarize non-qualified
Farms with the regulation the reason for this is that if you say you grow less
than $25,000 or gross less than 25,000 at some point you may want to get larger
and we want to make sure Growers are aware of what they need to do to comply
with the inspection if they do have to uh have an
How this came about
inspection so let's talk a little bit about how this has came about and and what we've been
considering uh extension works with the produce safety Alliance using their
framework to develop the components and the recommendations for the on Farm
Readiness review We felt this is very important because it's really a Continuum as it is
with most things in food safety you have a starting point but it really never
ends also s we are very sensitive the extension group to this to the lack of
guidance it's difficult to come up with recommendations at times when you really
do not know what the final uh rule was going to look like or the final guidance
we have a final rule but it's the interpretation of that rule that is a
concern also we want to avoid Mission creep what we were concerned about is we
come up with something and if anyone's had any experience with audits some
Auditors will say well you don't need to do this but it'd be nice or in the
future it' be nice if you did this it's not part of your audit but it' be nice and that's what we were concerned about
so we wanted to get something down written that everyone could refer to
whether it's a grower an inspector or an extension person so hopefully across the US it
will be as uniform as possible realizing we're dealing with humans and different
Modules
people will interpret them differently at times what we did was we put together
modules and there's 11 listed here and and these are used for guidance
documents the best that we can do right now without guidance from FDA uh on
these different areas and you'll notice it's broken into preh Harvest Harvest
and post harvest the reason we did this was you may have a grower who just plants the crop but someone else
harvests it or you may have someone who is running a packing operation but doesn't do the other parts that's why it
was developed this way and it does not full follow exactly the
way the rule is written because we wanted to put it together as parts that
apply to that part of the operation so you may have things for instance with water which may be in section one 11
12.35 and something else it's 112.1 0 and we put those into one
document and I'm going to show you a basic thing of how we did
Regulation
that this is part of the one module we have and you'll notice on the left side
is the regulation this is the text right out of the rule and it says 11
12.12 in the center column it says recommendations or possible activities
that may lead to compliance this is the plain English version as much as we can
do right now the left side is really the lawyer speak the center part is the
extension speak the third column is where we're putting in whether it's a document
that's required or a record or it may just be an observation on the on the inspector's part but we wanted to make
it very easy for a grower to uh look at and try to understand we'll talk about
some of the comments that Growers have made that have looked at this in in a few minutes the other thing we wanted to do
Section Rule
was to try to highlight those areas which were most important if you notice the on the
left side you'll see uh the section rule in red that means that that's what FDA
considers as the most important aspects not meeting other things are not in red aren't important but these are the most
important and things to take very serious when you're working with a grower to meet an inspection
Material Assessment
after we developed the material we tested it uh last summer in Michigan and we had FDA people USDA
people nasda and extension group uh doing these this assessment and we
sought feedback from Growers and also from the inspection and staff what we wanted we've spent the
last year really evaluating our material and modifying it after each time we did
a an on Farm assessment uh some of the challenges we
Challenges
found is far as the extension group is concerned it was too bulky we started out on 8 and a half by
17 or 14inch paper uh can you imagine taking 150 or
two 200 pages on a farm and trying to talk to a grower so we made modifications on that
uh we can't interpret the rule completely because we still don't have the guidance from FDA which they're
working on and we're waiting for those guidances so we don't get on a list of what is gotcha that that they they would
be looking for later on when we did this the extension people
Le LED all the the assessments or the reviews with Growers we did the talking
we did the asking of questions we did not allow and FDA did not want to talk
talk they wanted to listen how we did it and they were very surprised that we
could asked open-ended questions and getting getting long answers and soliciting information from Growers and
being able to come up with the same type of information they were looking for but without asking direct questions that may
respond with yes and no answers we wanted to solicit as much information we could get this led us to developing what
Walkaround Questions
we call walk around questions or walks these are paired with each chapter
in the resource guide and they cover the highlights in the
rule uh there are essentially 11 pages that cover the whole Rule and for each
walk there may be three four or five questions these are not the
final ideas or final words these are areas to open up conversation with the
grower but they do correspond with the the PSA modules and they correspond with
the resource manual we also are we give the grower a resource
manual uh before we leave so they have everything and I will talk about how we
went through the whole process in a minute so why a walk a traditional
regulatory approach is do you have a sick leave policy yeah can I see it yeah
here it is that's they check it that's it they got it with the walk it again
it's more conversational what's your sick leave policy we don't allow workers to touch
produce well how do you know if they're ill or not supervisors look for frequent trips to the bathroom other signs of of
illness we're trying to solicit as much information as possible to see if the grower really understands what they need
for a inspection if one takes
PreHarvest Sanitation
place this is just an example of the the walk around questions for part seven
which is pre Harvest sanitation do you do a pre Harvest inspection of the growing areas what do
you look for again soliciting that information and you notice that number there at the end of that question is
2.112 that's the the section out of the rule so if at a conclusion of your walk
around you can refer to that with the grower and look it up in the resource manual another how do you ensure
contamined produ will not be harvested again there's the section Rule and
there's more questions as you go down if you notice the third one there at the end it has a section number 112.1 123
but also brck it'ss a d that d means that there's a record
required so we want to make these things as clear as possible and as easy as possible for the assessor that will be
going out and working with
Hot Wash
Growers so we talked to Growers about what they thought of this and we had a
what we call Hot wash on the the final day of our reviews with Growers and with
the particip ipants and the The Growers have indicated one the resource document
is easy to read and easy to follow long but easy to follow uh they feel this is is a new
approach it's non-prescriptive it's much more open-ended one concern they had is they
would like to see it aligned more with a a thirdparty audit they would like to
see things are essentially the same in reality that's not going to quite happen
going to happen however FDA I'm sorry USDA is in the process of rewriting
their harmonized audit to try to come as close as possible with the fsma rule and
also I know some other private firms are doing the same thing they also wanted us to improve the
efficiency of the tool they did know why a grower needed to answer questions that
didn't apply to them they would like to see questions that if they didn't apply
then they could get ignored and they especially wanted that so the inspectors understood that this part of the rule
did not apply to them so based on their interest we developed what we call
Decision Tree
decision tree and these are just some of the questions for instance have you completed the PSA grower uh training or
an equivalent yes or no if no the website is there where Growers could go
to get get more information do you have operations covered under the produce role if they
did not know then again there is the website and in our resource manual we
actually have the uh decision tree that FDA developed to help Growers look through it to see if they apply everyone
has to do health and safety hygiene uh if if yes then then you check
that and I'll show you that form in a minute if no if operations are exempt recordkeeping requirements apply
depending on the particular exemption and I'll show you that module in a second also but this is the type of
question we ask there essentially 11 questions to help guide what parts the
grower would need to be inspected for or reviewed these are the actual list and
what you do as you go through those questions you check which ones you would would need to review so for instance if
they're not using ological soil Ms of animal origin that would get ignored so
that helps narrow down how much time it takes for the grower and really what's
important to look at at the farm if you may qualify for the
Qualifying Exemption
exemption qualified exemption then these are the questions and again this is a separate sheet in the guide do you grow
only or sell these crops which are the ones that are not covered uh do you grow only for personal you could check if it
is yes yes uh do you grow commercially processed with a kill step do you sell
less than $25,000 if you answer most of these then
you would qualify for the exemption uh if not then this is the
next step is how much you sell where you sell it what percentage uh and what your
dollar value is whether it's yes or no if you answer yes to both of
these your farm is eligible for qualified exemption and then the only thing that applies in that case of
course is is the labeling rules which go into effect later
on once we developed these materials and we did a couple on Farm assessments we
OnFarm Assessments
wanted to develop material that could be used for training everyone needs to understand
that right now we are not training assessors we're training we're working
on developing our materials and approving our materials before we start training assessors on a national
basis so what we've done is essentially the introduction which part of what I'm going over now uh expectation of
assessors and on Farm etiquette we feel this is very important especially with
you're working with people who have not been involved in agriculture what do you do when you get
to a farm how do you greet the individual uh what if a gate is open or
a gate is closed do you accept uh samples for instance step by step what
you consider one thing with with FDA is they have some people uh in the program
that are with the National Health Service and they're they're uniformed individuals so we've tried to stress
that they should not wear a uniform when they're doing the assessments we also go through the walk
around questions and a walk through what you should look at how you do it what
you leave behind with the grower uh We've made the decision that
any notes that are taken should be left with the grower you should not leave with anything it's the Grower's
information remember this is confidential it's voluntary you leave them the resource guide and any notes
you may have taken with this is about a half day that part then we do
action uh scenarios these scenarios are
actual Farmers interacting with a group of trainees to in the classroom to get a
feel how they work with Growers and then we critique them after each
scenario we then do farm visits where generally two were the first one the
trainers do the on Farm assessment with the grower and then the second one is
the trainees do the on Farm assessment and then we go through and critique them on how well and what what they may have
missed then we asked the Growers again on a separate day to tell us what they
thought of how the process went went we feel this is a a basic outline of how
training will be done in the future we're finishing up you'll notice on the
Testing Locations
next slide these are the testing locations we've done so far the actually
the last one is this week in Michigan once we finish these then we're going to
review all of our materials and make any final changes actually starting next
week we will be reviewing each SL slide set to make any changes we need to make
for for the training that will be coming up later
Team Approach
on so who carries out the on Farm Rance reviews it's hoped that it's a team
approach would be an extension person some from someone from the State Department of Agriculture or health
depending on uh who has responsibility for the FDA Grant and before the rule
goes into effect an FDA person this is not going to be always possible we know
that and FDA will stop uh going on them once the rule take goes completely into effect but we hope
the extension and someone from one of the state departments will be involved it's much better to have more than one
person do it uh that's why we think these are the logical persons to do
Funding
it who pays for this this is always the question is is money is tight especially
with the extension groups uh getting less funds and asking to do more things
Food and Drug Administration has provided grants to 42 States and
additional State I know has uh received funding this year so it's 43 this is a five-year project we're into this second
year of this five-year project some States including New Jersey are
subcontracting with universities to carry out the educational portion of the grant uh I know in New Jersey that the
the department of a felt that we could do a better job of doing that so we're already working with Growers on food
safety and this is a very much a close collaborative effort in this state
between the department and us where we meet on a regular basis and the department attends all of our
trainings I would encourage extension in any state to contact their Department of
a or health again depending who has the grant to see how you fit into this
organization there is money available for training there is money available to
carry out the on Farm Readiness reviews and I would strongly encourage you to
get involved sooner than later if you're interested and the reason for that is it
is a five-year project however the extension portion this is being front
loaded so it's if you're getting involved now you may be able to get resources to carry out something you may
already be doing just want to mention a little bit
Audit vs Inspection
about the difference between an audit and inspection because most Growers if
you're a wholesale grower especially have been probably involved in audits or at least you know about them audits are
usually point-based they're annual they're crop specific you in some cases
you may have one crop on the farm audited and none others and the consequences of failure loss of sales or
potential loss of sales inspection is not Point based it's intermittent it not
annual it may be for instance every five years it may be based on the commodity
you're growing the high-risk crops like such as leafy greens it does cover the
whole farm and there are regulatory consequences of non-compliance and those can be
uh additional visits those could be at some at very egregious situations
shutting down of an operation if you look at an audit this
is the USDA Gap audit and you notice the question there where it's in red Crop
Production areas are monitored for presence of signs of wild and domestic animals entering the land with an audit
a grower may say I can afford to lose those five points I got enough points to
part pass this I really don't want to do this but you can still pass the audit however with a fsma inspection
FISMA Inspection
it's not the same situation again if you look at the fourth block down there
where it says You must it does not say well it'd be nice if you did this you
must do this so this is this can lead to corrective action reports it can lead up
to follow-up inspection in some states depending on what the authority is there may be in fines
involved or worse so this is much different than an audit how does the on Farm readings
review fit into this it's really between the two we're we are preparing Growers
to take an inspection without the on Farm rais review having any regulatory
Authority we're trying to help Growers why would Growers want to do this it
Why would growers want to do this
helps match what they're doing to what's required in the rule it helps them figure out what they
may be missing they get a second set of confidential eyes on the farm that's
very important this is just for that farm and no one else it is
voluntary and again it is confidential and it'll improve the
likelihood of someone passing an inspection and I can't stress enough that it's confidential and it's
voluntary because the minute information is written down passed to someone else
it's no longer confidential and you're going to let lose uh working with those Growers on a
a regular basis so again as a review it's not
Its not pointbased
point-based it happens once in reality it may be more once if a grower want you
to come back and give for instance technical assistance and that may open up areas for additional activities for
extension it does cover the whole Farm covers critical areas on the farm
that are part of the rule and remember we're talking about just what is in the rule nothing else again voluntary and
Voluntary and confidential
confidential the way we see this it should be a Continuum Again The Growers should take the grower training the the
produce safety Alliance training or an equivalent then the Growers that take
that training can go through the on Farm read review and then they should be
ready inspection I know some states such as Vermont their idea is to have Growers
take the training and go through the on Farm race review before there would be any regulatory inspections and I think
that's a very good model because we want to bring Growers along we want to help them develop the
philosophy of food safety and that's really what we're trying to do and we're trying to protect Food Supplies and The
Growers bottom line so how will States be involved and
States involved
individuals in the states as I said previously what we've been doing is
developing the material developing the lesson plans to train individuals
uh series of trainings are planned across the United States starting in late fall of this year and through the
summer of of 2018 the idea again these will be Regional trainings it will not be state
byst state and there should be Grant funds through your state grants to
provide uh for this training and we will uh go around the state around the
country do the trainings and I'll show you where we're proposing right now so it's important that each state picks
the individuals who are going to be involved at the extension level and at the State Department of aen Health level
to take these trainings and also we will be having FDA people at these
Mentoring program
trainings so these are the proposed reg uh locations right now for the regional
trainings these have not been solidified uh the dates may change somewhat but these are the rough
locations of what we're we're talking about also there been some discussion
about a mentoring program where once someone goes through this training then
they would have an individual or a group of individuals they could contact if they needed additional help and in some
cases the trainers may be going out with Growers or I'm sorry with these teams uh
for a couple visits to see how they're doing so that's just in discussion and
we'll be having a meeting next month to go over this and make final
decisions so what if you want more information the National Association of
Contact information
State Departments of Agriculture you can see that phone number there and also the ad their email address you can contact
them about additional information and if you want to propose maybe a location for
a Regional training you can also so contact them so this gives you a quick overview
of where we are uh what we've done so far we will be meeting as I said in
September to go over the final documents and also getting ready to publish those
and hopefully we'll be starting the trainings in uh November the idea is to
do these trainings where we'll actually be able to go out on Farm after we do the the uh classroom training because we
want to make sure everyone understands what the steps are and how this is supposed to work are there any
Questions
questions great thank you Wes so much so I am going to go ahead and unmute
everybody and um if you are muted on your uh personal location you can go
ahead and unmute yourself or put something in the chat box and I also
wanted to in this time open it up I know we have some folks from the produce safety Alliance and from the Vermont
produce safety team on the webinar um to give them a chance to to add any final
comments or questions um for the group to to get the discussion going
Are growers in season
here so uh I have a call I have a a question in the chat box um from Angela
Shaw and she asked do Growers have to be in season for a Readiness
review Growers need to be in season yes because we want to see the operation how
they work how they pack uh if they're packing uh sanitation how maybe how they
they're sanitizing we want to see those things so yes they need to be in operation
Any questions
great any other questions and go ahead and you can speak up because everybody is unmuted so you can just uh just talk
and everyone will hear you or if you feel more comfortable putting it in the chat box that's fine too and again um I
guess I'll Betsy I don't know if you have anything you wanted to add or I see that Emma and Christina from Vermont are
on if you have anything to add from the pilot process that you guys just went through um first of all I think Wes did
My biggest concerns
a great job so I thought that was a a really good overview and summary um as I
think is I guess I'll throw out there some of my biggest concerns and I think Wes hit on these a little bit um without
inspector training without guidance some of this is is really tough as an extension educator I like going out
there and feeling confident in you know giving them information um but I think
there's a lot of unknowns yet but um the process so far has has gone really well
and and I think um I think Wes really really captured it well in his
FDA inspector training
presentation yeah and and I will reinforce what what Betsy said inspector
training is just starting FDA will have their first pilot uh in the Northwest in
August so they we are ahead of where they are and this is a big concern on
our part because we're not involved in that inspector training uh we would like to be but at
this point we are not so we're not exactly sure how they're handling
More questions
that okay great and we had a couple more questions come in the chat box um these
are in the theme of registration once uh we can start offering the trainings and
so the question is how big will the training classes be is there a limit to the number of participants
um will there be a Registration site and how will we be notified once the dates
and registration process is finalized and trainings are available some of that I can answer uh
Registration site
we honestly don't know how many people we're going to have in a training uh that's what we're going to decide in in
September some of those final things you'll be notified nasda will be putting
out information on where they will be how you register so those will be
forthcoming once we have those dates uh firmed up but as far as the number we honestly have not discussed that yet so
Press release
will um nasda be doing a big press release or a big announcement for that or is that something we should just be
checking back on their website for no they'll definitely be doing a a big press release and getting it out all
to all the state Departments of Agriculture and health to make sure they know and through extension we will get
it out uh to all the different extension services across the
US okay great uh so another question we have is does every farmer who grows
produce um have to have a Readiness review and can an extension person hold
a review on one farm for a group of farmers that's a good question and I
think that may be the way it would need to work in some areas however to me
that's more of a training and you still would need to do the individual Farms
reason being is that each Farm is unique and there may be things on one farm that
don't apply to another Farm or they may do it different which may have a different impact but as an initial
training I think that makes a lot of
Resources
sense okay great and then uh in reference to the documents that you discussed in the webinar um when will
they be available or other resources and and where will those also be on the um
nasda website uh nasda is as soon as we finish the final uh forms in in next month uh
meaning September because we're in August uh nasda will print those and they will make it available to at each
of the trainings to everyone uh we have not discussed whether it's going to be on their website or not but that's
something we can explore okay and you had mentioned that if you
Regional Training
wanted to hold a Regional training that wasn't already scheduled you could call and and do that is there a limit to the
number of trainings that you guys plan to roll out or is that pretty like if
there's a need that you'll you know try to make that happen well in reality right now there's
four of us doing the trainings or five of us doing the trainings uh and we only
have so many days and hours to do this so we have not made the final list I me
what we put up there is what we had proposed we could do uh if there are more then we need to discuss that among
the group to see if we can do it or not but if if you really think you need a
Regional training and I'm emphasizing Regional it will not be state by state
then contact nasda and express your interest okay great great and how long
uh will it take one Farm to complete the Readiness review it depends on the size of the
How long will it take
operation but we're looking at uh say two hours we hope that will be enough
but if it's a huge operation you know it may take a lot
Minimum number of hours
longer okay but we should be budgeting at least two hours minimum at the low
end that that's correct okay and so another question is um if there are
farmers who must comply by 2018 and the assessors are not trained
until after June of 2018 in the Northeast for example where
no date is given is it conceivable that the FDA would be going onto a farm
before a Readiness review is completed well I can be vicious and say
No date given
that's fda's decision well it is fda's decision but what we and again Vermont has uh is
going to do proposed is that they do on Farm Rance reviews first before there
are any inspections and FDA I think has bought into that but again we don't have
anything in writing and until you have something in writing you don't have anything for
Vermont model
sure okay Christina yeah I was just gonna say Christina do you guys want to talk a bit about the model you have in
Vermont and what you're planning to do yeah and so I'm just to clarify
that's kind of our our hope is that we'll be able to provide on Farm Readiness reviews to any farm that um
wants one before we undergo an inspection on that farm um you know
that's going to be subject to cooperation with our Growers and also um
you know the resources that we have in terms of staff um
FDA on a farm
but I would also just to clarify the previous question um in Most states at
this point it will be the state inspectors who are on a farm so I think
that certainly FDA could show up on a farm regardless of whether a farm has had an on Farm Readiness review but for
routine inspections um I think a lot of states are looking at at the very least
offering on Farm Readiness this reviews prior to inspections and some cases you know really pushing for that to be the
model um the one thing that I can't speak to with a great deal of depth but I will share is that there is also a
nasda inspectional approach working group um I'm a part of kind of a different arm of the working group than
those folks that are actually looking at what's going to happen on an inspection
but there are a number of states and FDA and nasda looking at a model for the
initial inspection on any produce Farm Really focusing on education so it's going to
be very different from an on-farm rating n review but um we are looking at a model where we would in very limited
cases take enforcement actions on those initial inspections and where those
inspections would really be focused on education and um kind of getting ready for a subsequent routine inspection
where there could be um some enforcement
consequences yeah and I I think something that Christine mentioned too is you know there's states have a lot of
leeway on how they handle the inspections or on Farm Readiness reviews
or in reality whether they do on Farm Readiness reviews or not uh We've
developing materials to hopefully help Growers prepare for an inspection and
that is really the role of this
project okay any other questions in the folks would like to ask we've got plenty
of time and I'd love to keep the conversation going because this is
great or if there are any other thoughts or comments from folks who are part of the on Farm Readiness review development
or Pilot process that want to jump in please feel
Any other questions
free I think I mean this is Betsy
again I see there's a lot of questions about what to expect from compliance and
can we get out there will we be trained I think there's a whole lot we just don't know um about expectations there's
educate before you regulate but there aren't Regulators trained the power is lying at the state level so
it could be that states choose different ways of doing this and um I think the
important thing is to engage in this conversation and to be aware of it so
that we're Nimble enough to make modifications when we need and as we go
How to budget for this
and um I just I kind of feel like our feet are on
a bit of sand on this one and in the sense that it keeps shifting a bit and
um and I think in extension we're used to being pretty Nimble um it gets kind
of wacky with funding that has deliverable dates I think that's what I'm struggling with now how to budget for this stuff if you're going to do it
um West in New Jersey I think has a a pretty good example of the Department of
egg working closely with extension that's not true in every state and um and so I think you if you're on here I
think you have to figure out what your State's doing and how to be part of that conversation and then stay on top of it
so that you know how to modify um to make it work I don't know if other
people agree with that or if that's just muddying the water too much but um it's kind of Loosey Goosey right now
I guess yeah this is Wes and I agree with
Betsy I there is you know 50 states of which 43 have
grants uh how you get involved with those again is is going to be state byst
state do you have someone You' have worked with in the past that you could contact uh is there already a mechanism
set up either through the University or through the either agriculture or Health Department you just need to I'll be
frank weasle your way in there if you're interested in doing this because if not
you're not going to be involved and your Growers are going to be excuse me your
Growers are going to be worse for it so I think if you're really interested now is the time that to get involved because
there is money available and it will be available for a relatively short
time so there was a question to I think just pull on some clarification a little bit there um which I think you just
offered Wes but uh must States participate in this training to do the far on Farm Readiness review or is there
Is there anything written stone saying
flexibility if you're going to do on Farm Rus review uh you need to go through the
training now is there anything written Stone saying you can't use the materials no there is not but we really encourage
you to go through the training if at all possible so I think the the question is
Are they required to participate
also um speaks to the states I think the Departments of a and health is what um
the question is targeting is are they required to to participate in this training or to provide the training I
guess to Growers or is there flexibility in and what they provide that they are not required to
Are there flexibility
provide the training there's no regulation saying they have to do this
uh what again what we're trying to do is develop materials that will help them work with Growers
Are there other questions
okay are there other questions that folks are eager to
ask and did that Diane I just want to make sure that that clarified what you
were trying to yes ask okay great
Thank you
thanks and Angela I guess I'll ask you you had a lot of questions in the beginning did you have any other
questions that you want wanted to pull
out no okay
great and I'll give another opportunity for last comments from people who have been involved in the process who want to
chime in how about Chris do you have any last
words yeah this is Chris so my I my involvement with the ofrr was um going
through the Vermont pilot um and so first thing I'd like to say is um thanks
to Wes for covering it in today's webinar so well uh really to me did a a
super job sort of getting the points across and giving a good overview of the of the tool and the process um and we
had a ton of people on um which uh to me suggests that it was something people were were uh very interested in hearing
more about so thanks for that um the process from my perspective again being
very involved in it in a very limited way has been a heavy lift and I really
appreciate everybody who's put so much time into developing the tool and uh the resources and the
materials um to to me it's sort of a critical link between the national
curriculum uh from the Proto safety Alliance and the uh inspectional um
activities that'll happen Downstream and um it also serves as a great way for um
extension Educators and other Educators to get more coordinated with uh State
and uh State Regulators in particular um so I I see it as a really critical link
between um you know in in the overall uh produce safety
um education and Regulatory Frameworks so that's all I really have to offer
just appreciate everybody's interest in participation thanks
Chris and I'll give it one last chance if folks want to put a question in the chat box before we end
today okay well thank you so much Wes for taking the time to do this and
provide us with this overview it's it's much appreciated and um thanks everybody for
joining in your interest and oh sorry there's just one more question that came in uh just to confirm is it intended for
extension person to lead the ofrr the yes I that's a short answer yes
we feel again this is the group me talking for the group put it that way we feel the extension has the best ability
to do this because they're working usually working with Growers they know how what to react with Growers I
also when we have have done the on Farm part of this in the past uh we started
out where only one person would ask questions and the other person would stay in the background we've changed
that a little bit if you have two people you can ask questions but one person must be the leader of that group and
that person we feel should be the extension person leading it and have in the final discussion the again the uh
extension person leads the final discussion
great thanks Wes okay so um it would be intended for the Department of a person
to I'm sorry it would not be intended for the Department of egg person to lead it but it would be best for them to be
there oh absolutely they should be there I it I think it's very important
realizing there's only so many people and so much time but if at all possible
I think someone from the Department of a and extension be should be there together going through it so they're
seeing the same thing and they're asking the same type of question so everyone
understand what's going on I just one other thing Elizabeth which I forgot to mention is you know some of the initial
contact can be done over the phone for instance if you may be able to do some of those checklists before you even get
to the farm uh which would again save some time and since these are voluntary
you know the Growers would be contacting say extension or the department of EGS and we would like to have one of these
the other thing is that Growers do need to go through the grower training the PSA training or equivalent before the on
Farm Readiness review that is very critical because the on Farm reads
review is really tied to the PSA modules it's a part of that Continuum
Egregious conditions
that I talked about before
okay we do have another question so at an earlier meeting it was explained that in the event of a finding of egregious
conditions on the farm the visit could become regulatory does that still apply if extension is leading the
meeting that is an interesting question uh my feeling this is personal
this is not coming from nasda is that if I'm an extension person
and I'm working with a grower and this is confidential uh uh visit if there is an egregious
position I will work with that grower on that egregious position uh I am not an inspector I'm
not a regulator I'm an educator thus I will help them change what the issue may
be okay and then there is a question about the voluntary nature of the the ofrr so there is some question about
there was a thought that um Farms would have to go through this review process therefore making it not voluntary is
that can you provide some clarification on that it is voluntary no one has to go
through this what again what we're trying to do is develop materials to help the grower be able to pass an FDA
or a state regulatory inspection does not mean they have to do it
but it sounds like from what Vermont is trying to do is that they were they are hoping to get everybody to go through it
but not um mandatory rather on a voluntary
basis yeah I think you know there's some state state tostate differences
obviously and each state is going to handle things a little bit different ways uh but as far as we're concerned
it's not a mandatory thing to do but a state probably could make it mandatory if they wanted
to okay any other
questions that was a good uh trickle of questions that came in there prompting a
little more discussion so I'll give it a second um and again if
I don't see anything I would like to I'll thank Wes again for his time and effort on this and everybody else for
joining and um appreciate your time today and with no further questions
coming in I'll go ahead and say have a great afternoon and thanks for joining today folks thanks Wes yep thank you all