Good morning and welcome everyone if you could please take your seats we're gonna
go ahead and get started welcome back to the public meeting day number two I'd
like to go over a few housekeeping items as everyone's getting settled so as a
reminder this meeting is being webcast live so please note that this is a
public meeting it's being recorded to video and if your publicly speaking in
the auditorium today you will be part of those recordings there is no expectation
of privacy the video recording the presentations and the transcript of the
meeting will be posted on the FSIS website shortly after the conclusion of
the meeting wings 4 and wings 5 in the building have restrooms for your
convenience and please note that food and drink are not permitted here in the
Jefferson auditorium so to open the meeting today I'd like to introduce Paul
kicker he's the Acting Administrator of FSI US
in the US Department of Agriculture
morning everyone my name is Paul kicker and I'm the Acting Administrator for the
food safety inspection service I want to thank everyone for being here today and
also thank those that are participating on the web as well I also want to thank
Food and Drug Administration for working together with us on this meeting so
yesterday we heard a lot about the regulatory framework that's in place and
we heard concerns that people were bringing up that pertain to that today
our focus is not going to be specific to food safety but it's going to focus more
on labeling of these products to make sure that the products are identified
according to customer expectations and so that the products are are labeled and
don't don't come up with any type of a advantage or a disadvantage to those
that are either producing this product or other products that would be in
competition with them so with that I just want to invite everyone to really
participate today and make your comments known yesterday was a little bit slow at
times today we we hope to keep things moving along a little bit if we get done
a little bit sooner than work than expected that's fine but we want to make
sure that everyone has the opportunity to make their comments known today so
with that I want to turn it over to Susan Maine with the Food and Drug
Administration thank you
okay good morning everyone as you heard my name is Susan and I direct FDA's
Center for Food Safety and applied nutrition you heard a lot yesterday
about potential safety hazards of foods and products created using cell culture
technology what comparators to use in interpreting those potential safety
hazards and potential strategies for addressing them today focuses on another
important part of our mission which is ensuring that food products are
truthfully labeled and are not misleading this is essential for giving
consumers the confidence in products developed using new technologies it
enables consumers to make informed decisions about their diet and what they
feed their families my colleagues dr. Douglas Valentine who directs FDA's
office of nutrition and food labeling and Malcolm Bertoni our associate
commissioner for planning will be joining the conversation today about the
labeling issues associated with the development of animal cell cultured food
products we need to be looking at how technology and transparency can go
together this is a theme we hear repeatedly consumers are increasingly
interested in the foods they eat and want transparent labeling as we think
about labeling of these products what information do consumers need for
transparency we also heard about the desire for labeling that can ensure that
consumers who have food allergies can identify the source of products to which
they might be allergic at both FDA and USDA improper labeling for allergens is
the leading cause of food recalls here we have an opportunity to hear about
things we may not have considered from such a diverse group of stakeholders and
to do this right in advance of products coming to the market public dialogue
like this is crucial to openly address both the opportunities and challenges in
being transparent that are presented by emerging food technologies such as
animal cell cultured foods in the nutrition innovation strategy announced
by Commissioner Gottlieb in March we committed to exploring how to make
ingredient information on food labels easier to understand
as the food supply becomes more innovative and diverse it's even more
important that we look at how we label foods one thing we want to hear about is
how much consumers understand now about food products produced by animal cell
culture technology do they understand the nature of the technology do they
have a perception as to whether it is more or less healthful or nutritious
than traditionally bred animals poultry and fish
what essential elements to consumers need on a food label for sell cultured
food products to truly understand what they are getting should the labeling
address how the product is made would such labeling give the consumer the
impression that the sell cultured product is equivalent to or
significantly different from traditionally bred animals poultry and
fish and when we consider appropriate labeling how much did nutritional
composition of these foods be a consideration and labeling how would
specific label terms affect how consumers perceive the nutritional value
of these products as you will hear today USDA and FDA work closely together on
labeling and food safety issues where appropriate we harmonize label elements
for consumer clarity so we are seeking your input today as to how labeling can
be most transparent and truthful and not misleading when it comes to these
innovative products we look forward to hearing your thoughts about labeling
considerations to ensure that consumers have the information they need whether
it be for nutrition or for safety for example with regard to allergens when
food produced from animal cell culture technology come to the marketplace and
you will hear more about this today from our experts in FDA and FSIS thank you
Thank You mr. kicker and dr. Maine some when you get started with session five
if you're following along in the agenda we're going to talk about the regulatory
frameworks for food labeling the mandatory elements so dr. Douglas
Valentine the director of the office of nutrition and food labeling at the FDA's
office Sif's Ann is going to begin with his overview of regulatory frameworks
for mandatory labeling elements following that mr. Jeffery Canavan the
deputy director in the office of policy and program development labeling and
program delivery staff at FSIS will give his presentation dr. Valentine
good morning everyone it's a pleasure on behalf of the Food and Drug
Administration to be here this morning and to share with you the regulations
that we have in place that govern our our food labeling I think you'll you'll
find that you know we work quite closely with FSIS I mean Jeff and I have worked
together on food labeling and Codex our teams talked to one another on a on a
regular basis so I think you'll you'll hear what FDA does and you'll hear what
USDA does and you'll see that there's quite a lot of alignment for the most
part between our approaches to labeling so I think by the time you hear us both
you'll have a good picture on how the labeling rules that are in place could
might be applied to products produced from cell culture technology food
labeling regulations have been around for a long time it started in 1906 with
the pure foods and Drug Act it was amended in 1938 where it was renamed the
Federal Food Drug and Cosmetic Act which we still use today and that that Act is
the primary law that we follow still today that governs labeling and
packaging of food products and as dr. Maine has said one of the overriding
principles around labeling is providing information to consumers that is
truthful and not misleading and to make it clear to consumers what the foods
that they're getting are what's in them how much is in them what the nutritional
composition of those what the ingredients are so I will go over how
that how those those come together whoops let's see somehow that doesn't
look like the right one
where is it here
maybe go back one is that one shouldn't be where it is they're weak mmm dudududu
that's good let's see here you go back one more
actually this looks like my presentation for this afternoon so
while they find some slides I can continue a little bit alone to keep us
moving so there's some other regulations in place that govern our food labeling
regulations there's the food additives amendment that was added in 1958 that
governed the regulatory structure for allowing food additives and food we had
the nutrition education and labeling Act of 1990 that really put into place many
of the the Nutrition Facts label in requirements and a number of the other
nutrient content claim requirements there's the FDA Modernization Act of
1997 that that governed additional labeling requirements and finally that
was felt in 2004 which really put the requirements in place around allergens
and foods and that put the mandatory labeling of the the big 8 allergens in
place so those are some of the main regulations that you can find online
that govern labeling of food products there's some other regulations as well
that govern food products there's the fair packaging and labeling Act which
put in place their requirements for net content statements so that consumers
could accurately compare one product to another product in terms of knowing that
they can know how much the way it is they compare price they can compare
value so that assured that consumers had an idea of what was in products and then
there's a number of other food labeling regulations that can be found in 21 CFR
part 101 and then Sif's and issues a food labeling guide to help companies
weighed their way through many of these regulations in more consumer friendly
terms and we issue a number of food policy guides that that that govern food
labeling so those are really the laws and the regulations that we use to guide
our our compliance work in terms of food labeling and one of the things that is a
difference between FSIS and and FDA is we do not do pre-market
approval of food labels we we do approval or we look for food labels for
compliance based on our inspection post market
I think though so while they go on just to be clear what constituted its
labeling so from an fda point of view labeling is all the written material
that appears on a on a package both the principal display panel and and the
other display panels of a package so any wrapper or packaging material it also
can go to accompanying material so shelf talkers or shelf tags that might be put
adjacent to a product in a grocery store can be considered labeling and when a
company website is is put on the package material that is then linked to the web
content is also considered in in many instances to be an extension of labeling
of that food package so in in terms of modern technology where we have a lot of
e-commerce we have a lot of information available on websites labeling can be
considered to be quite broad in terms of the the information that might be
considered web labeling as part of a food food product so when we think about
labeling FDA regulates foods and beverages that you find in most grocery
stores we regulate food if it contains less than two to three percent meat
otherwise USDA regulates those products that contain meat so it does read some
confusion so for example FDA would regulate a cheese pizza whereas USDA
will regulate a pepperoni pizza so there are some buttons and some differences on
which one of our organizations would regulate the product depending upon how
much meat or poultry or fish would be in those products we also regulate labeling
of seafood and game meats for some products such as catfish which you heard
yesterday we share jurisdiction with USDA what we're USDA is now doing the
inspection part of catfish but we still regulate a certain amount of the
labeling of those particular products and as I said before we do not pre
approve labels but we we view labels as part of inspections so as our inspectors
go out and do Safety and inspections around the various factories that you
heard about yesterday from Doug Stern and others we will look at the labeling
materials and and we will determine whether or not the labeling of those
particular products being manufactured is in compliance with the labeling
regulations so we do have quite a bit of compliance activity that that we do to
make sure that labeling is accurate and and consistent with our regulations and
so one of the roles we have in terms of labeling is education and and and these
great electronic worlds you still can't get one file from one place to the other
Canada so we do issue guidance documents and a variety of regulations and
compliance guides to make it clear what the labeling regulations are and how
they might apply to various food products particularly as we we are
seeing an emergence of many new and novel food products that are being put
into place particularly because of either consumer preference or new ways
of production or new ways of manufacturing so an example that would
be is is using cell based technology we also work internationally on food
labeling through Codex Alimentarius where we participate in the food
labeling committee in addition to the nutrition committee so that helps us
also guide food labeling for international commerce so we can assure
effective trade with with partners around the world so that's another
element that we work and we work quite closely in those areas with USDA as well
I'm not gonna get there no I can just keep going that's fine jeff has slides
and he has a lot of pretty pictures that will basically show you what I'm talking
about so we'll just keep going it'll be fine so when it comes to food labels
that FDA regulates there are a number of elements that are required mandatory and
then there's a another group of elements that are considered to be optional or
voluntary so the mandatory elements and it came up yesterday one of them one of
the most important ones is really the regulatory name that a product must
carry we call that the statement of identity and I'll spend quite a bit a
little bit more time a little later in my talk talking about statement of
identity but statement of identity is really the regulatory name that a
product must carry so that a consumer knows what that product is there must be
a statement of quantity of contact contents and that needs to be present in
in both pounds or ounces but also in metric that determines the amount of
material in a product there must be an ingredient statement on the product that
captures the the ingredients on them they're listed in the order of
descending amounts and they must be listed in either in a regulatory name or
the common unusual name of the product the ingredient statement would not
contain for example an incidental additive or certain process AIDS for
example as they aren't alternately ingredients in the final product
unless exempt the it must also contain the name and the address of the
manufacturer or the co-packer or the importer if it's some product coming in
from outside of the United States the information must have a street address
so that that consumers or FDA can contact that manufacturer and it would
be considered not an acceptable label if that information is not on the product
it must have nutrition information there are a few examples where they're
exempt but for the most part it must have nutrition information as I said
earlier with FAL pup if it contains any of the the Big Eight declared allergens
it must disclose the presence of those allergens on the food package and it
must have information that would disclose other material facts that might
be related to the safety of a product and I'll come to that in a little bit
later and there's a number of voluntary elements on the food label all of which
might must be truthful and not misleading and that could be a variety
of claims which we'll talk about this afternoon or other information that a
manufacturer would think might be important to providing transparency to
the consumer about the particular product that's being sold so I'll come
back to going over the required elements in a little bit more detail and then
spend a little bit more time on the the statement of identity so the statement
of identity as I said before is really the regulatory name of the product the
the statement of identity is is oftentimes if there is a standard
specified in the state standard of identity of a product that has been
established in regulation other examples are common in usual names
so oftentimes a product that's used over a long period of time has a common
unusual name an example is honey for example it doesn't have a state standard
of identity or maple syrup but over time people know what honey is and they know
what maple syrup is if there isn't a common unusual name that that is a that
has been arrived at over time then there must be a statement of identity that
could be a simple term if that was sufficient or it might be a statement
that that better describes what a particular product may or may not be and
oftentimes sometimes a fanciful name might arise as equivalent to
a common unusual name so for example two two examples might be vanilla wafers is
a short but descriptive term for what a vanilla wafer might be and sometimes
brands become synonymous with a particular food for example most people
know what an oreo is and you don't need any further description to determine
what what that particular product is if it's a traditional Oreo there must be a
net quantity of contents as I said before that must be an inch pounds or or
in metric and you're not allowed to quantify that further like large or
jumbo although large or jumbo might appear someplace else on the package and
as I said there must be there must be an ingredient list let's say so now we'll
come to the Nutrition Facts label as many of you know we've just recently
modernized and updated the Nutrition Facts label it was updated in May 27th
of 2016 but we issued the final rule we have recently updated the compliance
date from July 26 2018 to January 1st 2024 large manufacturers in January 1st
2021 for small manufacturers you'll start to see those labels appear in the
marketplace now quite a few labels have already been updated I was going to show
you some pretty pictures on what the old label and the new label look like but
but what you'll see is that the basic iconic form of the label was retained
but serving size and calorie information was bold and made larger particularly
with the need to make sure consumers understood how many calories were in a
food product and what the serving size for that particular food was
particularly we thought that was important to address the obesity crisis
that continues to to grow in the United States some of the other changes we made
is we've now required the addition of added sugars to the label as the intake
of added sugars results in nutrient dilution and
is it difficult for consumers to get the nutrition they need within their calorie
needs so we've added that we've changes some of the requirements in terms of the
mandatory nutrients that are required in labeling so now vitamin D and potassium
are two nutrients that are required or as vitamin C and vitamin A are no longer
mandatory elements of the label because they are no longer a public health
concern so we've made some additions to that the other update is the quantity of
vitamins and minerals as they're expressed or not only expressed as
percentage of the DV which which is what they were historically but also have
milligram amounts so those are some of the changes we've made to the label
we've also made some changing in terms of the serving size rule so when a
product is up to 300 percentage of the serving size or the rack as we call it
you must have dual column labeling because those particular products could
easily be consumed in one eating occasion and we wanted to assure that
consumers not only knew what the nutrition information was per serving
but also the nutrition information per package and we made some some other
changes in terms of large products that might be consumed in single servings so
for example up to a 20 ounce bottle of a beverage will be considered a single
serve and must be listed as a single serve so when you look at the nutrition
information there you'll see the calorie information and the nutrition of that
whole package again making sure that consumers have the information they need
to be aware of what they do if they consume that packages one whole
container I've already talked about food allergens
and just to acknowledge that the major food allergens are milk egg fish
crustaceans shellfish tree nuts wheat peanuts and soybeans so those are those
are the main food allergens as we see technology emerging for example we
discussed it yesterday in terms of cell based technologies where the same
proteins that we would expect to be allergens in traditional agriculture we
would expect to be present in in cell based agriculture so we'll need to
consider allergy labeling so we're seeing a number of changes related to
food manufacturing and allergen labeling that need to be taken into account and
the other thing that our if there's material facts that are important
particularly from a safety perspective we expect that to be on the label so for
example you can buy psyllium husks that are ground up to use as a source of
dietary fiber if they're not dissolved appropriately they can they can create
choking hazards so there's a warning statement to avoid choking hazards
there's another example is low-fat vegetable oil based spreads are not
suitable for frying and there needs to be a warning label on the package or an
advisory label on the package to just say not suitable for frying because the
the water content of those low-fat products leads to extreme spattering
which which creates a health hazard so we that's the type of information that
we would also require on a labeling as part of material of fact so I'll come
back quickly to statement of identity one more time just because that that's
really the key regulation that involves the naming of products and just to
reiterate that those are the types of that's the regulation which is not
easily understood but really applies to to what would be the appropriate
regulatory name and and the name that that would are sure that a consumer
understands what a product is and what a product is not
just see whether this anything here that would um that would add to what I've
already said
so what we would say is the general principles that we use for determining
naming of products is is the name sufficient to describe the basic nature
of the food that people know what it is and what its intended use is we just dr.
main brought it up this morning is that the name of the food sufficient to
determine whether or not a particular food has a different nutritional content
so for example would you need to name a product that is simply a source of
protein or a vegetable based protein but doesn't have a lot of other nutrients
simply to reiterate protein content or a protein type food whereas products that
are more complete and nutrition that would would would be used as part of for
example Dietary Guidelines food group intake you'd want to see labeled in a
different way so that a consumer would really know how those particular
products not only in the naming but also in terms of nutritional composition fit
into their diet patterns to assure that consumers know the appropriate use of
those particular products within their dietary context another aspect of of
common unusual names might have to do with percent characterizing ingredients
so you know something that is 50% of more of a particular ingredient or an
oil or something like that would characterize it as one source of it
whereas something that is less than 50% of another ingredient would characterize
it as something else so for example what you might see in the marketplace is
there's now a lot of products out there that are blends of butter and vegetables
to make them healthy so if the butter content is 50% or higher then butter
would be the characterizing ingredient in that particular food whereas if the
oil was let's say a canola based spread was 50 or 51 percent then the canola oil
makes the dominant part of the label and that would be the characterizing
ingredient that would be used in determining the name
so characterizing ingredients and the predominant ingredients do take a role
in in naming of these particular products so we have a number of general
principles that we've applied that you can see in the CFR that would that you
can be referred to that that looks at how we go through in determining
appropriate naming of particular products and we would apply these
particular rules to any new products that are appearing in the marketplace so
I think that more or less wraps up what I wanted to share with you this morning
I've shared with you the the mandatory elements that need to be on food labels
and some of the voluntary elements that are required on food labels and some of
the principles around naming of particular foods these are the the
regulatory frameworks that we would use toward thinking about how you might
label and name products that would be emerging from cell based technology for
example so thank you for your time
thank you and good morning I'd like to emphasize that you know what reiterate
with Doug mentioned you know FDA and USDA of a very long history of working
closely together and I think you'll will see as we taught up the discussions
today about the mandatory elements regulatory and guideline development you
know consistency across all food categories is an important consideration
as we develop regulations and other policies and so I'd like to start off
today's discussion with talking a little bit about the principal display panel
it's it's similar to FDA's definition it's the part of the label that is most
likely to be displayed presented or shown or examined under customary
conditions of display and so looking at the picture here on the slide
FSIS would consider the the from these packages as they're displayed in the
retail case the principal display panel and so FSI as does have specific
requirements for certain mandatory features to appear on the principal
display panel and those include the product name that we'll talk a little
bit more depth about inspection allege in the USDA mark a handling statement
and also the net weight statement in some cases so here's just an example of
a principal display panel if you could see this product displayed in a retail
case at your local grocery store it has the the required features there the USDA
mark in the lower left hand corner net weighed handling statement and a product
name so as Doug was mentioning there's quite a bit involved in the identity the
naming of a product there's many factors that come into play want to be if there
is a standardized name there's standardized names in the regulations
and also in in informal policy standards as well so for example FSIS has a
standard of identity for a frankfurter or a hotdog it can it's pretty specific
to fat limitations or combination of fat and water limitations limitations on the
certain use of ingredients and others regulatory standards can be a little bit
less prescriptive and for example a beef stew really the identity
he just specifies the minimum meet requirement which in the case of a beef
stew is 25% a ground beef is one that it's a little bit more prescriptive it
is very I should say limiting in a sense has a maximum fat requirement of 30% it
actually prohibits certain ingredients such as water binders extenders and
phosphates so really you're limited to dry continental seasonings that can be
added to ground beef other within the absence of a standardized name the next
here would be is there a common or usual name that would apply and so a beef
ribeye steak you'll you'll see that's commonly used in the marketplace
referenced in various publications as a common or usual name that consumers are
familiar with for a particular cut of meat and so that would be an acceptable
product name cheese quesadilla pepperoni pizza would also be an example we don't
have regulatory definitions or so I should say standards of identity for
these products but they are considered acceptable
Konnor unusual names there's also products in the marketplace that have a
descriptive name in the absence of common or usual name these could be a
unique blend of various ingredients some meat and poultry and some ingredients
under FDA as well and so I think a good example would be some type of mixture of
chicken and vegetables with cheese and a pastry it doesn't doesn't necessarily
have a common or usual name or standardized name but it accurately
describes the characterizing components of that product and then sometimes we
also have what's called a nonspecific name and this would be one that really
can't stand alone as a product identity it doesn't give the consumer enough
information on the characterizing ingredients of that product it's not
specific to the species of meat or kind of poultry that is used and so an
example would be a chuck wagon patty and so we would expect that that would be
followed immediately by the ingredients statement or possibly followed by a
descriptive name so here's an example of a chicken nugget product whole grain
bread it shaped chicken breasts with rib meat patties
the next emphasize requirement is a handling statement this would be where a
product requires special handling to maintain its wholesomeness typically
you'd see keep refrigerated or keep frozen there are certain situations
where a product is distributing Commerce in a frozen state and then thawed prior
to retail sale and sold in refrigerated state and that would have the last
example of the handling statement there about previously handled frozen and
there's an example of the handling statement of keep frozen the net weight
statement it's required for all products sold at retail there are some caveats to
the net weight for random weight consumer sized packages that way can be
applied prior to retail sale it does not have to be applied by the federal
establishment and there are certain exemption for example products that are
going to hotel restaurants and similar institutions and there's an example of a
net weight of 5 pounds the USDA mark of inspection is one
feature that's unique to FSI as regulated products every establishment
that has a grant of inspection has a unique number associated with that
establishment and so the mark of inspection that's applied there's
there's two marks but talking about a meat or poultry the one on the left
there is for meat and the other is for the poultry and the establishment number
is required to be displayed it doesn't have to be in the mark of inspection it
can but it can be placed elsewhere on the package and that helps identify the
product in commerce if there's a need same event of a voluntary recall or some
type of other market withdrawal and so there would be an example of the poultry
mark of inspection on this poultry product now the information panel is a
particular location on the package other than the principal displaying a lot of
times it's not feasible to put all the required features on a principal display
panel and also it's not a regulatory requirement so there are certain
features such as the ingredient statement nutrition facts panel and
signature line or address the name and address of the Packer that
can appear on the information panel and one requirement and our regulations is
for one of those features are presented on the information panel they have to be
presented together in a contiguous manner and you can see this example
where the nutrition is off to the left and the ingredients in the address liner
to the right but they're all placed together now a very important labeling
features the ingredient statement and it's required when there's two or more
ingredients are used to make a product FSIS as regulations we also have
guidance available that further clarify ingredient labeling requirements going
back to the regulation for a moment there is a requirement that all
ingredients be listed in descending order of predominance course with
labeling there are exceptions one would be is for ingredients that are added
that are considered minor in nature there's provisions for listing them in
any order provided it's prefaced with a statement such as contains 2% or less of
the following and then those ingredients can be placed in the order we also have
I mentioned guidance of particularly clarifying some ingredient labeling
requirements we work very closely with FDA in the joint FDA and emphasize
ingredient approval process that oftentimes we get questions for example
how flavorings should be labeled you know spices such as black pepper and
white pepper and red pepper can be listed by common a usual name but they
can also under our regulations be listed as spice or flavoring that's not such
the case with ingredients of animal origin so if a hydrolyzed beef protein
may be used for flavoring but we require the species of livestock or the kind of
poultry to be declared so you couldn't label that as flavor and have to be
labeled as hydrolyzed beef protein and there's an example of an ingredient
state
well it's not a whole lot of time on this it's the the name and address of
the manufacturer if it's the name of the establishment the federal establishment
on the grand of inspection it can just be the name and then also the the city
state and zip when listed in the phone directory it
can identify the the name of the company that the establishment is producing it
for maybe it says particular grocery store chain for example but in that case
it would have to be prefaced with a term such as distributed by or manufactured
for to indicate that it's the name and address of that entity as opposed to the
manufacturer and there's an example the address line nutrition facts we we have
regulations in place that's required for most products again with labeling there
are certain exemptions want to be small business exemptions or products for
hotels restaurants institution that you know they're not intended for retail
products for further processing now an important part of these exemptions
though is that the label cannot bear any nutrition information or claims that
would kick it out of the exemption and then require Nutrition Facts information
so there's an example the safe handling instructions is one feature that's
unique to meat and poultry products and it's also unique compared to other
labeling features and they can appear anywhere on the label so it can be on
the information panel the Principate principal display panel front riser
panel and it needs to be on any meat or poultry product that's not ready beats
of raw raw meat the ribeye steak for example would have safe handling
instructions on and it provides consumers additional information on how
to handle the product to prevent cross-contamination cook thoroughly and
also how to properly handle leftovers and so there are exemptions for example
products going for further processing at another establishment consumers would
not see these products and there are requirements for how it needs to be
displayed such as a one-color finally with the require Lamy features for
products that are imported into the United States they have to identify the
the country of origin underneath the product identity on a media container so
here's an example of a product of Denmark
of canned ham product name so here's just an example of a label for ground
beef where all the product all the labeling features I should say are on
the principle display panel the follows an example where they're split and you
can see that the required features the mark the name that wave handling
statement are the PDP the restaurant the information panel that would be in
compliance with emphasize regulations and as mentioned yesterday and Doug
mentioned this morning FSIS does implement a prior label
approval program and this is we draw our authority to regulate meat products from
the federal Meat Inspection Act and there actually is language in the fmia
as you can see in the second bullet here where it talks about labeling and
containers which are not false or misleading and which are approved by the
secretary are permitted and so USDA has always interpreted that as that
statutory language as mandating pre approve of all labels prior to their use
and commerce offered for sale now we've established based on that Authority
we've established regulations related to the prior label approval system which
we'll talk about here in a moment and then also about other labeling
requirements they talk they they tie back to the misbranding provisions of
the Act we have certainly other types of labeling requirements such as product
name qualifiers than our regulations that we've conducted rulemaking for and
it's all related to making sure that the consumer has the appropriate information
at the time of purchase to make an informed purchasing decision and also to
make sure that that label is truthful accurate and not misleading so I will
talk a little bit about the types of label approval and types of labels that
you'll see on products generic labeling you know we talked about how all labels
are approved by the agency there is a subset that are approved by the agency
they're just not physically submitted to the agency for approval they're
generally more basic in nature and have the required features a sketch
approval the whether it's a sketch label which is really the concept of a label
and we do require certain sketch labels to be submitted to the agency for
evaluation and approval and will ultimately give those sketch approval or
sketch modified which we'll discuss more in a moment we also have final labels
those are the labels that are actually apply applied to the finished product as
they go out into commerce and we also have labels that are considered
temporary which are used in certain situations so for the labels that need
to be submitted to FSIS for evaluation honors prior label approval program we
met at our regulations in 2013 effective 2014 to require four categories these
include labels for temporary approval if you're not familiar with temporary
approval if a label is deficient in some particular maybe an ingredient is listed
out of order but it doesn't create a health or safety situation and does not
provide the company and economic advantage we can grant temporary
approval to use that label why changes are made so just a couple examples if a
company was making a claim such as grass you know made meatball made with
grass-fed beef and they had some issues with their supplier and they wanted to
use beef that was not grass raised we would not grant that temporary approval
clearly a granting that temporary would provide that that company economic
advantage so we would not do that relating to ingredients I mentioned
minor changes but for example of salt was you know tenth in the order of
predominance and now they wanted to adjust it to be second and it
significantly changed the nutritional profile that product so the amount of
sodium was was greater than 20% of the declared on the label that's another
situation where we would not grant temporary approval because it would be
of concern to some individuals particularly and although sodium dye for
example so we evaluate those on a case-by-case basis labels for products
produce honors religious exemptions very small category essentially they may
deviate from some part of a regulations such as head on feed on poultry
labels for products with export of labeling deviations and this is you know
we've been talking today and we'll talk later today about domestic labeling
requirements we do allow deviations from those domestic labeling requirements if
they're for export only and if they're in compliance with the importing
countries labeling requirements and so when we conduct our label approval we're
looking for information to support that it is the label is in compliance with
the importing countries labeling requirements and finally the largest
category of labels that we see fall into this special statements and claims and
we publish guidance that identifies not only the examples of label claims that
are commonly used on meat and poultry products but also in some cases the
documentation that needs to be submitted to support the label claim for label
approval and the reason why FSIS requires these four categories is
because it felt that these four categories were more likely to present
significant policy issues relating to health or economic factors so we're good
transition into a little bit here about the the labeling records we do have
requirements we actually updated them in the 2013 rulemaking as well
the final label again that's the label is applied to the product needs to be
included in the labeling record product formulation process and procedures and
anything to support other claims that may be made on the label to support that
they are truthful and not misleading and so these these labeling records are
important because our inspection program personnel that are in the plants are
conducting label verification activities which whilst us a little bit greater
detail in just a moment and so they need to have that information available to to
not only verify label approval in some cases but also to conduct that
verification activity in one such activity falls under directive
directives provide permanent instructions to our inspection program
personal personnel and unless they're deleted modified or amended so we have
permanent structures in place for the ongoing formulation verification has
as mentioned yesterday in a presentation you know there's been a sustained number
of recalls for undeclared allergens many of which were the result of implant
inspection activities and so this this directive is targeting particularly
products that are multi ingredient products contain other ingredients such
as purchased seasoning mixes or other purchased foods if you're making a
meatball and it's formulated with bread that's gonna be a purchase component and
so the inspectors are looking at what's actually going into the formulation
comparing it to the product formula and the labeling record also comparing it to
what's declared on the label and our specific instructions on how to document
a non-compliance and also to prioritize the highest risk products essentially
when conducting that label verification activity again we're targeting these
multi ingredient products that may contain one of the big eight allergens
and then there's a jump when a head there's a general label of verification
activity and this is republished in 2014 when we update our prior label approval
and so it provides instructions to inspection program personnel on how to
conduct a label verification activity essentially what features should they be
looking for them the mark of inspection the handling statement are they in
compliance with their the regulations and its focused again on the final label
a sketch is an important part if you're if you need to get your label approved
by the staff but really what we're verifying is that the label on the
product is it consistent with the product formula and what's in the record
to protect public health and so when labeling is not compliant there are some
corrective actions that an establishment can take they could submit for temporary
label approval and we would evaluate on a case-by-case basis whether temporary
approval is appropriate again ensuring that there's no public health or safety
issues or providing the company economic advantage in other cases the label can
be brought into compliance with pressure sensitive stickers essentially to cover
a feature that may not be compliant to bring it into compliance and finally I
wanted to talk today about procedures for rescinding or refusing approval and
our regulations for the rules of practice we do have the authority if a
label is found and we made agency might find an label on a product in commerce
that's not in compliance they would bring that to the attention the labeling
staff or maybe from a competitor that might find a product in commerce that
they don't think is in compliance so we'll evaluate those on a case-by-case
basis and determine whether they're in
compliance with emphasized regulations in the case they're not we can reduce a
label to temporary approval if there's no health or safety issue
or we could resend the label to prevent its future use and so there's a lot of
ongoing working with our inspection program personnel as you can see with
with the verification activities and also in some cases resetting or refusing
approval we're working closely to get more
information about the products and then how to and then what actions may be
taken if they're found to be not in compliance and that concludes my
presentation thank you thank you Jeff and thank you Doug I think that was a
lot of really helpful information and you can certainly tell they're both
experts in their field next we want to talk about the current landscape for
food labeling we're gonna start off with Matthew Michael he is the director of
the issuances staff in the office of policy and program development and FS is
followed by dr. Douglas ballantine the director of the office of nutrition and
food labeling it's of San Matthew
good morning as Selena said the topic of this session
is the current landscape for food labeling and I'm gonna get there by
telling you about a petition that USDA received back in February this petition
is one of several catalysts behind not only the current ongoing examination of
animal cell culture technology by USDA and FDA but also a catalyst for this
meeting
so as Selena said I am the director of the issuance of staff in the office of
policy and program development at FSI us not surprisingly the issuance staff and
the office of policy manages the development of policy issuances these
would include Federal Register publications such as notices proposed
rules and final rules which could pertain the labeling guidance to
industry which also could pertain to labeling instructions to our inspectors
which many of you will know as emphasize directives and notices which could
pertain to the verification of the truthfulness of labeling and FSIS
responses to petitions
so let's talk about petitions a petition for rulemaking which is what we
typically call it is it is a written request to FSI us to issue amend or
repeal a regulation or policy anyone can file a petition with FSIS we have
regulations governing the petition process in volume nine of the Code of
Federal Regulations in part 392 the regulations contain instructions on how
to submit a petition describe the type of information that may help FSIS to
review a petition in a more efficient manner and they also permit interested
parties to comment on the petition while we're reviewing it after a petition has
been filed FSI evaluates the requested action to determine whether we should
grant or deny the petition we consider the supporting information included with
the petition as well as any comments we receive after we complete our review we
inform the petitioner in writing of whether or not we will grant or deny the
petition what action will take and we post our response on our web page as
well all our petitions comments and responses to comments are available to
the public both in our docket room here in the South building and also online in
the event where we have a petition that generates a lot of public interest and a
lot of public comment we often also put it on regulations.gov and that's the
case in the petition in question I'll be talking about today
and this is a screenshot of regulations govern it you can get there for our
petitions often by a link on the FSIS website petition page but you could also
go directly here and they have a number of ways you can search for our
regulations or petitions comments and those of other federal agencies so the
petition in question this is a petition is was followed by the US Cattlemen's
Association or us CA as I'll call them concerns the labeling of cell cultured
meat products and other products that may be marketed like meat but are not
meat necessarily it was submitted to USDA on February 9th we've received over
6,000 public comments all of which are on regulations gov I looked yesterday
there's six thousand one hundred and fifty nine right now it's still under
consideration we continue to examine the petition and the supplementary material
that was provided with it it was a lengthy petition a lot of attachments
we're looking at all the comments on the petition and we'll be considering the
comments made at this meeting and submitted in writing in response to this
meeting
so what did you SCA request first they asked us to limit the definition of beef
to products from cattle born raised and harvested in a traditional manner second
they asked us to lemon that limit the definition of meat to the tissue or
flesh of animals that have been harvested in the traditional manner and
notably they made a point in their petition that they wanted these
definitions to distinguish traditionally produce meat not only from product
products cultured from animal cells but also from products made from plants or
insects that are labeled or marketed like meat also interestingly the
petition does not request that we change our regulations they don't request that
we go through rulemaking to affect these definitions instead they ask that we
amend what's known as the FSIS standards and labeling policy book the policy book
is guidance it's intended to help industry produce labels that aren't that
are neither false or misleading but also you can use the the guidance to create
what are called generically approved labels labels that would not have to go
through prior approval so the the policy book is incorporated by reference into
our regulations but it's not a regulation in itself it's it's guidance
you can use and that's an interesting facet of this petition
so our response to this petition in light of the development of cultured
sell products will obviously be an example of how we respond to the
labeling of new meat and poultry products and again we'll be considering
all the comments we received the supplementary information information
before we respond FSIS has a lot of experience in regard
to the labeling of new meat and poultry products because it being developed all
the time as well as novel processes to treat those products and I'll give you a
few examples so we have irradiated products we published regulations in
1999 so we actually have regulatory requirements for them for their labeling
which include the inclusion of the red aura it's the radiation symbol on the
label as well as a statement that the product was irradiated or the way use of
the word irradiated as part of the product name we also have advanced meat
recovery products we have labeling requirements that are determined by the
constituents of the the final product of advance me recovery it determines
whether it can be called pork for example or mechanically separated pork
instead we also have it's not totally new it's developing a process high
pressure processing we don't have positive labeling requirements for those
to you you don't have to state that on the label but we have reviewed a number
of claims regarding high pressure products high pressure treated products
on the labels of those products and then a final example is products with
modified atmosphere packaging and we have labeling requirements for those
products depending on the gas that is used for the modified atmosphere in the
package so for all of these products and for future products such as cell culture
products we would apply the same statutory and regulatory standards
ensuring that the labeling is neither false or misleading and to make sure
that consumers are given enough information to make an informed purchase
so I hope this discussion by getting there by way of talking about the
petition was helpful in in showing how FSI Asst reviews the labeling of new and
novel products thank you
so this time I wasn't planning to ask slide so we're we're in a little better
shape I'm just in it make some brief comments about the the current landscape
I think as well where where the the food marketplace is rapidly changing in
innovating as new technologies are being matured and and become economically
viable to use to produce new products in novel ways I mean for example the the
topic of this particular public meeting is looking at how cell culture
technology is being developed for the applications of producing new food
products bringing unique products into the marketplace we've seen rapid
advances in in agricultural changes for example we've gone to greenhouses too
now we are entering the age of vertical farming where we have large warehouses
growing fresh produce that are across from large distribution centers that are
rapidly allowing fresh products into the marketplace that's changing the dynamics
of how we get agricultural products we see the emergence of insect proteins
being explored as a way of cheap inexpensive high-quality proteins to
assure that there's sufficient protein available for meeting the needs of the
the growing population and through biotechnology and bioengineering we're
seeing the evolution of typically food ingredients that would only appear in
from animal sources are now being produced from plant-based sources so we
have hemoglobins being produced in plants that can be used in in production
of plant-based patties we're seeing dairy proteins being put into a variety
of plant sources that will allow those proteins to be produced from yeasts and
other plant sources so the landscape is rapidly changing
so we're can we're looking at that landscape and looking at how we need to
add our view of our regulations to take into
account the rapidly changing landscape clearly will continue to always focus on
the principles that clear truthful and not misleading labeling will be critical
foundations to making sure that consumers are understanding the products
that are coming into the marketplace and can understand how they are either
similar or different from more traditional products in the marketplace
with a focus on making sure that these products are both safe and keeping track
of whether or not these new products are nutritionally adequate or how they're
nutritionally different from more traditional products because we do
believe that that truthful and not transparent and transparent labeling is
really critical so that consumers can build diet patterns that are consistent
with our national guidelines because those diet patterns are essential to
public health and in doing this we do maintain very strong partnerships we
work closely with USDA and and this meeting is an example of one of those
partnerships we also work closely with CDC and NIH in order to make sure that
all of our work is is based on sound science so we really do you that this is
a critical time for us to be looking at the emerging landscape of how the food
landscape is changing and that we think we can really make sure that we can
advance public health as a public health agency by empowering consumers with the
right information to facilitate building healthy diet patterns and at the same
time enabling industry to innovate into the changing landscape and marketplace
as you might all be aware of Commissioner Gottlieb who spoke
yesterday announced earlier this year our nutrition innovation strategy which
is looking ahead at how FDA can begin to take a fresh look at how its regulations
can be applied in part to this changing food landscape in order to help
build healthier diet patterns so while the strategy is still in in its earliest
stages of development we are looking at how we might amend our food standards
principles to take into account the rapidly changing food landscape to make
sure that it has the flexibility to do what it needs to do but also allow
product innovation we sit with that we're going to update that the
regulatory definition of healthy and we hope to to be coming forward with the
proposed rule on what that new definition might look for and we're
looking at at looking at how we approach our health claims which I'll talk about
this afternoon we did have a public meeting earlier this year on July 26 to
begin the public dialog similar to this meeting around how the nutrition
innovation strategy might be developed and evolved and we had an open docket
that closed on October the 11th just a couple weeks ago we received over 5,000
comments from the public into that docket and are currently looking at
reviewing those dockets as that that public comment period is really critical
to inform us in part on the way forward and I would all encourage you all to
also take advantage of the opportunity to provide comments into the docket that
will be open for this particular meeting because public comments are critical the
petition process and that you heard from USDA F FDA has a similar petition
process where citizens or groups can petition the FDA asking us to consider
changes in our policies or regulatory actions and as USDA had received a
petition around labeling of these cell-based products we've received a
citizen's petition from the good foods Institute who you heard speak yesterday
asking us to consider a naming framework on how standardized terms such as milk
or meat might be used in the naming of plant-based alternative foods so we've
received that petition it's it's up in the docket so people can also look at it
and comment to that docket and similar to USDA we are currently looking at a
petition and considering how we might respond to that petition but public
comment again is critical to helping us make sure that all can have an informed
and voice in how we might move forward in reviewing that petition that would
set that the basis for how we might name a variety of plant-based alternative or
alternative food products that will be emerging in the marketplace in the
future so in closing I'd really like to say that this morning we did share with
you some thoughts on food labeling and you can see that that there is a lot of
consistency between the labeling approaches of both USDA and FDA we
really look forward to continuing the dialogue today and hearing your views
and your input on on food labeling because your input is critical so thank
you
okay well we're running a little early this morning we're running ahead of
schedule so we're gonna take a break a little bit early let's reconvene back
here in 15 minutes so that'll be five minutes to the hour we'll see you then
you're gonna go ahead and take your seat so we'll get started in one minute
okay welcome back I hope everyone got a chance to stretch your legs we're going
to go ahead and move on to our next session which is open public comments
and I want to introduce Malcolm Buitoni who is the associate commissioner for
planning at FDA welcome back everyone and good morning my name is Malcolm
Bertoni and the associate commissioner for planning at FDA and I'll be your
moderator for this next session as you know from yesterday if you were here or
if you haven't I'll just explain that one of the important purposes of today's
meeting is to gather input and commentary from the public and this
session here is an open comment period so you do not have to have signed up if
you have some particular thoughts that you would like to share we very much
want to hear them we are soliciting comments on the labeling aspects of the
discussion that we've had so we would appreciate it if you have comments that
you do share them on labeling and if we have time we can perhaps entertain some
other comments as well but we will we have two microphones down here near the
front of the stage here and we have some uh sure's who can help maintain orderly
lines and we ask that you just come down and the ushers will direct you to one of
the two microphones now in order to make sure that we allow everyone to have an
opportunity to speak today we do have a three-minute time limit for each comment
so there's a screen where you can monitor your time available also we very
much would like for you to state your name and your affiliation
so without any further ado let's start the session and begin with our first
speaker
hello my name is Liz Holtz and I'm speaking today on behalf of the Animal
Legal Defense Fund I'm set to give formal comments later this afternoon but
I'd like to offer the following comments about the issue of safety addressed
yesterday I want to first thank the USDA and FDA for the opportunity to
participate in this public meeting the Animal Legal Defense Fund commends the
agency is forgiving this critical issue of animal agriculture technology such
careful consideration the potential for animal cell culture technology to
transform how we produce meat and other animal products cannot be overstated
conventional production and slaughter practices are inhumane unsafe and
environmentally destructive and more and more consumers want alternatives in
light of the enormous benefits this technology offers we urge USDA and FDA
to employ an efficient and transparent regulatory pathway that Spurs innovation
while ensuring product safety instilling consumer confidence and preventing
deceptive labeling for all animal products whether made from slaughtering
animals or culturing cells on the question of safety innovation in the
meat industry is urgently needed conventional methods rely on the
intensive confinement of animals in unsanitary and inhumane facilities these
unnatural conditions require extensive use of antibiotics to address diseases
that proliferate among the crowded stressed animals contributing to the
spread of drug-resistant superbugs animal slaughter further involves broad
potential for adulteration as meat comes into contact with fecal matter and other
contaminants these adulteration risks are compounded by overly fast
slaughtering speeds that make detection of contaminants and disease more
difficult and the turning over to ill-trained slaughterhouse workers of
critical food safety inspection tasks a program USDA is at this moment poised to
expand a pig slaughterhouses nationwide in contrast to slaughtering live animals
meat produced using animal cell culturing can be produced in a septic
controlled environments that present significantly fewer and different food
safety threats the vast differences between these production methods
that USDA would not be the appropriate agency to regulate their safety even if
it had jurisdiction over their production instead FDA should build on
its significant experience regulating other cell culture technology
applications to develop a process that ensures food safety for these new animal
products thank you thank you for your comments and I know we have some
technology to help us with the time line but it does require a manual step so we
need someone to help me in the clock
great thank you
thank you for the opportunity to submit these comments I'm Jessica Alma I'm the
policy director from the good food Institute we appreciate the agency's
thinking through these issues to ensure that adequate information is provided to
consumers and bright lines are created for producers thinking about labeling
cell based products consumers are enthusiastic about these products we did
a poll with the confirmed analytics and we found that two-thirds of Americans
are willing to try meat grown from cells without slaughtering animals and 40%
said they would pay a premium for these products the expectations are that these
products are healthy safe and environmentally sustainable while
looking and tasting the same as conventional meat as to the FDA's
specific questions yes the source of the cells the species from which the cells
come should be required information on the label this is important to protect
consumers from potential allergens as dr. valantine pointed out earlier we
also think that there needs to be flexibility for labeling requirements
standards of identity have shown that they have limited utility in light of
other disclosures on labels and it's difficult if not impossible for federal
agencies to keep up with the growing choices in the marketplace fundamentally
standards of identity or state excuse me statements of identity must follow to
the two principles that dr. Mane enumerated in her remarks this morning
for all aspects of the label that they be truthful and not misleading
plant-based products regularly reference mate counterparts to convey information
on their flavor profiles and how they're used they also use modifiers like
plant-based or vegan on their labels so long as consumers are not misled these
products are not mislabeled we of course urge FDA to grant GFI's petition which
was mentioned before the break we have every expectation that cultured meat
companies will have incentives to set their products apart when they're first
introduced into the marketplace initially the products will be clearly
communicated the way that their products have been produced because it's
important to consumers and they will command a price premium over time we
think it's important to see whether the production process is material to
consumers as mr. Canavan said labels should provide consumers the information
they need to make purchase decisions in the supermarket moreover they should not
advantage some producers over others we look forward to providing formula and
comments on this topic and thank the FDA in USDA for this opportunity thank you
for your comments
good morning my name is Barbara kowalczyk I'm from the Ohio State
University and please forgive me I have a bad cold but I'd like to make a couple
of comments on labeling and risk communication which has been basically
talked about this morning I would like to preface this by saying I'm an
epidemiologist and statistician by training my PhD is in environmental
health and I would love to see food products that can be developed that can
be that can be proved produced in environmentally and sustained friendly
and sustainable ways that said I have some significant concerns about some of
the claims that are being made about these products these products have been
put out in the public purview as being clean meat which may give consumers the
miss miss representation that these project products are sterile they will
not be sterile as a member of the food say of the FDA science board although I
do not speak on behalf of the FDA science board and I encourage everyone
to read the transcripts from Monday's discussion which we had in depth they
product the environment in which cell based products are grown in cell culture
medium is very conducive to the birth of all pathogens and so if that becomes
contaminated there won't be contamination in the ultimate product in
addition the scaffolding elements that the owners used in scaffolding was
allowed no products may have hazardous effects on the public and that needs to
be clearly labeled during the consider during the labeling process how do we
available what has gone into growing the product and then in the cell culture
medium so for example in some cases based on the research that I read human
growth hormones are being used to produce to in the culture medium and how
is that going to go into the labeling process the other thing that I think and
I see my time's running out the other thing that I think that is important for
the agencies to consider is these products are being touted as being more
environmentally friendly and sustainable than traditional meat and poultry
products I have no idea I do understand that there are significant environmental
impacts through a traditional production but I want to understand how is this
going to differ I think that the impacts would be different but I still think
there will be impacts at the FDA science board meeting on Monday it was stated
that it will take five thousand liters of fluid to produce one to two kilograms
of product that's half of a milk tanker what happens when we have contaminated a
product that that cannot be put put out onto the market pace where is that we
call product going to go where the byproducts of this process going to go
if companies start marketing this as being environmentally sustainable do we
have a definition of that for the labeling process and that's something
that I think my times up so I will stop there thank you thank you very much
we've did your name and affiliation hi my name is Michael Hanson I'm a senior
scientist at consumers Union the at the advocacy Division of Consumer Reports an
independent nonprofit organization with 7 million members worldwide
nationwide that works side-by-side with consumers for truth transparency and
fairness in the marketplace and I'd like to talk about is we did a survey of a
nationally representative phone survey using random digit dialing of 1018 US
adults this June and the data were statistically waited so that respondents
in the survey are demographically and geographically representative the u.s.
population the first question we basically asked is how Americans think
the packages should be labeled and the first question we asked is if you were
to see a package for purchase at a grocery store or other location
containing food that is produced in a laboratory from animal cells to look and
taste like meat how do you think the package should be labeled only 5% said
it should be called meat without any further explanation
a little over half 52% said it should be meat but accompanied with an explanation
as to how it was a produced 43 percent should've said it should be labeled
something other than me we then asked people for what should actually should
it say on the label we gave them seven choices and we actually randomized those
choices in terms of how we ordered them those seven were lab-grown meat
artificial or synthetic meat something without the words meat beef pork third
was animal free meat such as no pig pork kalus beef cultured meat clean meat and
in in-vitro meat the two that were at the top lab-grown meat 35% said that it
should be labeled at 34% should it said it should be labeled artificial or
synthetic meat and at the bottom were clean meat at 9% in vitro meat
8% and then a little about that at 11% was cultured me so we think consumers
have made it clear that how they would like to see this product labeled is
number one it should make very clear how it was produced and number two they
should use terms that consumers understand and from our sampling that
clearly shows it's either lab-grown meat or artificial meat because those
collectively got almost 70 percent of the samples and again at the bottom
where in vitro meat clean meat and cultured meat so we think this should be
labeled as either lab-grown meat or artificial or synthetic meat because
that's what consumers have said the and one potential problem with cultured meat
or even so cultured is some consumers might think might not realize what
culture means they could think that oh does cultured meat is a cultured meat
product one that for example likes opera and all these other things which is a
different form of culture so I think we have to use term that consumers
understand and will submit this will also make detailed comments and sub sub
submit this survey to the docket thank you very much
my name is Ames Perry I'm with the director of food resource which is a
regulatory consulting group to the food industry and I just wanted to know
yesterday during session two dr. which was the potential hazards for cell
culture of Technology products derived from livestock and poultry dr. Fasano of
FDA mentioned the nutritional manipulation of cultured meat and
poultry products the possibility to do that which of course will impact
nutrition claims but I think there are a lot of other claims that could be made
about the altered nutrition that need to be considered when we're looking at who
needs to regulate this and I think because FDA does not do prior label
approval I would also make the case that those considerations would make it more
natural fit for FSIS Thanks thank you very much
hello Mike Selden co-founder and CEO Phyllis foods in terms of Waveland I
just wanna make one quick point lab-grown meat has a name is not just
wrong it is it's just incredibly inaccurate we are not going to be
producing anything at scale in a lab a lab is by its nature single like small
experiments it's the same way that beer is prototypes like in any brewery that
you go to you will find like a white room lab coats science type benches
black tabletops and that's where they'll be prototyping and designing new types
of beer which is then produced in a brewery and so to use the word lab-grown
meat and to even suggest if that as an option in this case is intentionally
misleading and also not setting up a fair playing field if we are lab-grown
meat then beer is lab-grown beer so if you're gonna change our label change
that one - thank you thank you
yet again good morning my name is Eric Scholes I am the vice president of
product and regulation and Memphis meets as Secretary Purdue noted yesterday in
the next 50 years the world will demand as much protein as has been produced in
all of human history to this point to feed the growing planet protein
production must increase and become more efficient this will require many
innovative partners including traditional food producers large and
small as well as cell based meat poultry and seafood companies to meet this
challenge this pursuit of innovation must occur not only in industry but also
within government appropriate existing regulation allows for such innovation
while ensuring safety through sound risk-based policies and no one company
industry or government agency can address this alone
Memphis meets strongly believes and has stated previously at cell based products
and Technology are an and and not an or solution recognizing our shared desire
to support innovation and feed the growing world Memphis meats uses the
term cell based meat and poultry to describe the products that are result of
animal cell culture we know that a wide array of terms have been used to
describe our products and technology in this room in the media by stakeholders
and even within our nascent industry and I'd like to take a moment to explain why
we believe that cell based meat poultry and seafood is the right term to
describe our products and technology some terms like fake synthetic or
artificial meat are intended to not only cast our products in a negative light
but are also simply false and misleading we're making real meat and seafood and
that's the whole point the term lab dome has an act accuracy
problem as well as with many familiar and currently marketed food products the
early development of our products happens in food labs but the products
that we bring to consumers will be produced in food production facilities
not labs we also no longer believe the term clean is the right term well we've
used it in the past primary intent was to highlight the
sustainability aspect and control production environment we are developing
since then we've heard feedback from many stakeholders and we've learned that
the term clean can be confusing is perceived as disparaging and does not
fully convey our process and product to consumers and we value that feedback
that's why Memphis means has begun using the term cell-based meat poultry and
seafood this term is clear factual and inclusive it organizes products into
categories that will help consumers it is distinct from plant-based proteins in
animal-based meats it differentiates our products will also clearly convey that
Memphis meat earth that cell-based meat is in fact real meat we are encouraged
by the fact that others are beginning to use this term cell-based as well now we
know that determining the appropriate terminology for food labeling depends on
certain factors including the characteristics of the finished product
and applicable standards of identity or other regulations as we continue to
continue to answer these regulatory questions we hope that using the term
sell basis open the door for a broader conversation and commitment from all
stakeholders to describe the products of animal cell culture and a clear accurate
and transparent way moving forward we look forward to working with
stakeholders as well as USDA and FDA to clarify the appropriate labeling
terminology and regulatory framework for cell based meat poultry and seafood
ingredients we think the agencies for convening this important meeting and for
the opportunity to comment thank you thank you
it looks like the line has died down so I'd encourage people who are thinking to
come on up and offer your your comments
too-tall hi everybody my name is Alice tan I'm the CEO of simple foods
collaborative or just simple a new research and development company
intending to one day commercialize blended cell based lean fish products
along with Memphis meats we've been calling the products we hope to
commercialize one day at sell base since July for all those reasons I am very
lucky my mother passed away two years ago at 90 in love and in peace
completely healthy mom used to say there were two kinds of people in the world
those who ate to live and those who live to eat she was one who lived to eat and
Cornish hens lamb chops and ground beef were her proteins staples therefore I'd
like to start by thanking the USDA and FDA for your organization's important
work in keeping us all safe fed and healthy past present and future
I'd like to then extend my thanks to all of meat and poultry and seafood if
you're here I will never forget my gratitude for helping to give my mother
such a long healthy life we have an extraordinary safe food system in the
USA so I'd like to circle back to the conversation about allergens and build
on what Mike Selden brought up yesterday around allergies to fish and also build
on what Susan May raised here earlier today around how improper listing of
allergens is the leading cause of recalls quick poll how many a quick poll
how many of you know what yellow perch is or wahoo their species of commercial
fish so it is estimated at four point zero point four percent of the u.s.
population is allergic to fish that's 1.3 million Americans who are allergic
to fish that's not selfish which is another 2% of the population that
overlaps I believe the right thing to do for cell-based fish for maximum consumer
safety is that the ingredients label and allergy contains labels must not only
make it clear that the food product in question contains a specific species but
also make it clear that it's fish fish is one of eight allergens with
specific labeling requirements of the food allergen labeling and Consumer
Protection Act of 2004 under that law many factors of packaged food products
sold in the US and containing fish or a fish product as an ingredient must
identify on the ingredient label in clear language the specific type of fish
use so as I understand it it must list the species but because we don't know
what these things are wha-hoo people are who are lured to one
fish are generally advised to avoid all species of fish unless they specifically
know they are not allergic to that fish so unless we learn otherwise it's safe
to assume that the proteins responsible for fish allergies will be present in
the cell based fish protein we intend to one day grow and harvest that's why it's
not enough to list the species name to minimize serious allergy reactions for
1.3 million Americans the ingredients label and contains label need to make it
perfectly clear without ambiguity that by considering this product the consumer
is consuming fish and is consuming wahoo it's also why we can't call it
artificial because then people will wonder if they're going to be allergic
to it or not in conclusion to avoid serious dangers to those with fish
allergies all cell based seafood will need to include labeling this has both
fish and wahoo both the word fish and the name of the species in closing I'd
like to remind us that everyone here wants to feed people safe healthy and
clean food we share the same interest thank you again to the USDA FDA and
everyone here from racing a rational thoughtful collaborative and empathetic
science-based approach to regulating cell based meat poultry and seafood
thank you thank you and let us know if you if those are going to be your formal
comments or okay great thank you
so the line has died down again I'm going to display if I can the second set
of a slide a second set of questions on the other slide just in case that
inspires some additional thoughts that folks may want to share so would anyone
there we go
thank you for sharing your name and affiliation Danny beer the US
Cattlemen's Association I just want to thank start by thanking all of USDA and
FDA for having this I know it was kind of the answer to our petition that that
brought this up and certainly appreciate your collaboration on this so the
questions that you guys have asked I would say yes to all these questions we
should have standards of identity to identify these products as different
than beef and meat we feel that beat and meat have already been defined consumers
when I travel tell me all the time that when they purchase product at the
grocery store they think of what we're doing is families on the land taking
care of the land taking care of those cattle every day they don't think about
somebody putting a group of cells together and growing a new product
that's not beef should the methods by which animal cell culture proteins are
produced be communicated as well yes it should be I truly think people people
know how beef is produced historically this is a new method it needs to be
explained explicitly should the source of the
animal cells be put on the label yes how should products containing both
animal cells and cultured products or traditional meat be labeled I really
think they shouldn't be combined that's my opinion if they do I think you need
to label that as such and probably they need their own identification and
inspection system altogether I don't think it should be the same beef
inspection system at all thank you thank you
hello alert I'm Brian Spears co-founder and CEO of
New Age meats we make pork so pork from animal cells instead of animal slaughter
and I'd like to I have the distinct and rare privilege of being able to taste
our cell based meat so I remember the first time I did taste it which was
about a month and a half ago we were making it for the first time and we had
several containers of meat some of which we had bought in the store port we
bought at the store we ground it up because it was similar to what we were
producing and then we also have the stuff that we made we had them in
different concentrations and we had a chef there that was cooking up our meat
and we're trying first we've tried one sample and I ate it and said ok that's
bacon recognize bacon so what's next and the other chef said no no that's that's
your meat and so I said wait that's it's not like when I ate it it's not like it
was or was like meat it was meat it was perfectly mistakable for me because it
is meat in fact we then fed it to 40 people who came and had our cell based
pork sausage and including a reporter from Business Insider and to quote her
it tasted like meat then again it is meat I wasn't sure I would have been
able to tell the difference between this pork sausage and any other when we go to
market and label this it will be simply dishonest to label it as anything other
than meat thank you thank you
so if there are any other folks who are planning to give their formal public
comments or anyone who would like to provide some additional comments you may
come forward
Barbara Kowalczyk The Ohio State University I don't have any formal
comments this is just an additional comment I think it's really clear from
the good discussion this morning that there's a lot of debate about how to
label these and I think that this is something that the agencies are going to
have to look at very carefully involve social and behavioral scientists in
determining how to label this one thing that always strikes me when I come to
these meetings and other scientific meetings is we get into these
discussions as should it be cell based or cultured every person in this room is
not normal okay we know things that most of the American public does not
understand and so what we think it should be labeled in some ways is
irrelevant we need to engage normal average consumers in in-depth studies
and that's going to require a lot of engagement of social behavioral
scientists in figuring out how to label this appropriately so that the average
American consumer who may not know what a culture is and may not remember what a
cell is as sad as that may sound to adequately describe this risk to them
okay there are going to be risks with this product it's not going to be
risk-free and we have a hard time explaining the risks with traditional
food products to the American public and I for those of you that don't know me
and I want to also comment and I have my grandstand here you know I've heard a
lot of people talk about how safer our food supply is and it is
it is one of the safest in the world and I do want to commend the agencies for
the work that they do but there have been a large number of recalls from both
agencies just in the last week and someone made the comment earlier that
most people understand how our food is produced no they do not
most Americans are out of touch with how products are produced in this country
and so I want to caution us in making a lot of assumptions about what people do
and do and do not understand about these risks and that's going to require the
agencies to do a lot of work which is actually pretty difficult for them to do
given some of the the data reduction act and things like that doing the kind of
social and behavioral research that we need to do around these products is
difficult so it's going to require partnerships from academia and from
industry to get that done before we can have a full vetted conversation about
how these products should be labeled and I'm going to make it a stab a play I'm
going to also request again that we think about how these are going to be
really labeled in terms of environmentally sustainable and clean I
know I'm at my limit but one of the things that I've heard is repeatedly on
Monday yesterday and today is the fact that antibody antibiotics are not going
to be used in these products that is not true
and microbials will be used in these products if they produced in an aseptic
environment they have to use antimicrobials to get there and so these
are things that consumers are aware of their environment they're concerned
about the environment they're concerned about antibiotic stewardship and if
these products are not labeled properly so that consumers have the information
they need to make informed decisions it's going to be misleading I'm not
saying I have the solution I'm just saying that there's a lot of work that
needs to be done to figure this out thank you thank you
next speaker
hello I'm sure Natan glued for many years I worked at FDA doing
communications and and stakeholder engagement I am now a private consultant
and I monitor a number of these issues and I'd like to make a comment one about
communications in to about stakeholder engagement
the one about Communications builds on what Barbara just said I am aware of the
consumer research that both sides have done and I don't think anyone's
surprised by the findings that both sides have come out with based on who
they are and I would urge that for anyone truly
interested in this issue now is the time to get it right
spend the money take the time to do real consumer research not just serving
surveying simply what oh here's five names what do you think of them what
does this mean to you that that this that's an important step it's not the
first step it's not the key step this is a new technology it has to do with food
you have to put your communications and thinking of the naming in the context of
how people eat what they think about their food why they want to consider a
different type of meat why they love the meat that they eat whether they'll
consider how does this fit all together really listen to them it's not a quick
survey of here the five names or here the you know more names and what do you
think they don't know enough about it so rather than just tell asking them for
the names probe deeply to understand how they think about it and how it will fit
what the context is and I think from that everyone will be able to come out
with something that will be far superior I also think that it's wonderful I heard
memphis meats and some others talking about the stakeholder engagement and
that it actually moved them away from the term clean
I think that's remarkable and wonderful I think it's completely understandable
that the industry hated the term clean for obvious reasons and that was very
good that they spoke up about that and it's very good that that there are those
who are considering what other alternatives are if there's that kind of
reasonableness if there's a true willingness to have USDA involved and
FDA involved in their respective complementary manners I think that we
can do a lot better than what happened with GMOs and so I would hope that maybe
some of the lessons of what FDA did on FISMA collaborative forums that were
hosted by in that case it was pew look for some groups who have not staked out
such a strong position but can be the true mediators and bring together I
think there's much that everyone in this room can come out with something it's
ultimately all about consumer confidence and and the more that they're seen as
being two sides who are battling each other the more that that raises concerns
among consumers about eating meat and eating this this cell-based meat or
whatever the term is that ultimately is decided thanks very much thank you
next speaker
hello I'm Brett Kinsey I'm a cattle rancher from South Dakota I'm here as an
individual and this is not my official statement I do have a couple impromptu
statements that I've come up with as I listen to this and I've gained a
tremendous appreciation for what USDA and FDA do
I appreciate what they do and I appreciate the task that they have ahead
of them statement 2 again unofficial in last two
years live cattle supply chain ranchers have dramatically changed their use of
antibiotics people made to call and we answered now a vet prescription is
required for all antibiotic use label directions have been changed for
antibiotic use we've always had withdrawal times for antibiotic use then
one more thing I thought of well I came up here is antibiotics are expensive
people we only use them when we need them I'd like to finish her the question
how will antibiotic use be regulated in cell culture technology will they have
prescriptions to get will they have withdrawal times to respect thank you
thank you very much do you have another commenter
see I don't know if I'm tall enough Eric my name is Jack Bogle I'm with in tracks
on and just a couple of comments the first is that I think a lot of the
challenges with labeling that have been raised this morning apply to our entire
food system I think that consumers really don't understand many consumers I
think it's about a quarter don't understand whether or not a cow was
involved in producing low-fat milk so any we need to recognize the starting
point that we have for the entire food system and so there definitely
challenges I think people have never cared more nor known less how their food
is produced and that's a challenge for all of us
people care passionately and they're asking for things and changes to our
policies and yet they have very little understanding what our food system is
all about today so there are broader goals that we need to achieve in terms
of educating the public about what our food system is and I guess I don't
really see a huge amount of difference in this room on the labeling question I
think that on one hand we have the companies they're producing cell based
products that passionately want to convey to the consumer that their
product is different so if they want to convey that information then the
question is how to convey that information and so I think we need to go
through the process of making sure that we convey it in the best way possible
so I think that on both sides of this conversation everybody wants that to be
the case so hopefully we'll focus on the things that we have in common
I think it's also worth pointing out that people love innovation almost as
much as they despise change and there's no place they despise change more than
in the food they eat food is what brings us together as family as friends and if
you mess with my food you're messing with my family but if we don't change
how we produce food everything will change
and so I that you know we need to recognize that
the agriculture industry has changed dramatically over the last thirty years
it uses 50 percent less water to produce a kilogram of beef from the livestock
industry they've done amazing things and this is just one more change we need to
produce 50% more protein by 2050 if a hundred percent of that was cell-based
it wouldn't impact a single livestock producer on the planet and so I think
that you know there are opportunities here and that we're going to achieve
that in multiple ways so I guess I'd like to close by saying that we have the
best food system in the history of the world but it's also the worst food
system we'll ever have because it's going to get better as we go forward
thank you thank you very much
so we have some additional time it's not Sunday so we can't break for brunch so
if you're thinking about a particular comment or perspective that you'd like
to be considered now is a great time to come on up
you might be on the edge teetering should I offer it can I need you toward
the microphone there we go hopefully he's heading this way not that way thank
you hi I'm Nigel burrow I'm an attorney I'm speaking on my behalf
here on on the question of labeling and kind of a statement of identity for
these products I don't think at this stage we should be prescribing a
standard or prescribed nomenclature I think you know putting a bunch of people
in a room and asking them whether they're you know linguists or scientists
or marketers asking them to kind of come up with a new word that people are
actually going to use is pretty much impossible whatever these products end
up being called I'm pretty sure it's probably gonna be something that no one
has thought of in this room no one suggested at this meeting so as a
starting point I would look at the kind of appropriately descriptive term branch
of common or usual names for these products describe perhaps different
companies will describe differently what the product is as long as consumers are
aware of the basic nature of these these products that should be fine as a
starting point and then as consumers become familiar with them and and
perhaps adopt their own term or perhaps like the Oreo a certain branded term
will kind of take over the the entire category as kind of a shorthand for
these products like you know Xerox or Kleenex or in some quarters even Coke is
kind of shorthand for any soft drink that could very well happen here so so
long story short I think that developing standard prematurely
for what colles products is is not the way
agency should go and so that's that's my comment on the labeling issue I have
formal comments that I'll give later thank you thank you very much I think
this is a point where we say that no specific mention of a particular brand
constitutes an endorsement by the FDA or the USDA if you are sitting there
thinking that you know I have a perspective that's a little different
from any of those that have been expressed to date you might seriously
consider income coming up and offering that perspective it's important that we
hear from a broad range of viewpoints and we have the time or if you're
thinking that you might want to get out a little early and give your formal
comments this morning instead of this afternoon that would be fine
as well great we have a taker
Aric sumption from south dakota cattle producer just one quick comment our
industry's taken a lot of heat over hormones antibiotics things like that it
comes down to an educational issue with me nobody's ever educating me how this
process works and what it involves we talk about consumers consumers are very
important if we don't educate them so they understand this product no matter
what we label it are they really gonna interpret what is it me as a cattle
producer if we've worked a long time to build trust between consumers and stuff
like that that's why I urge these companies or individuals that are doing
this technology to maybe step back and educate us so we understand it it might
help us be more accepting to what you want to accomplish thank you thank you
very much
my name is rocky foreman from south dakota
i believe that the definition of meat should be restricted to the tissue of
animals that are born raised and harvested in the traditional manner i
bring two perspectives to the conversation the first is that as
someone who grew up on a ranch in south dakota and who has worked with family
farmers and ranchers throughout my adult career i've seen firsthand the time and
sacrifices producers make to raise raised safe high-quality meat for their
families that consumers around the world with each with each successive
generation these ranching families have worked to improve the stainability of
their operations and the quality and safety of their products I also bring a
unique consumer perspective as a father I became increasingly aware of food
labeling when my four-year-old daughter Meili was diagnosed with celiac disease
if he came clear to me how important clear straightforward and honest food
labels are for the health of health and safety why proteins produced using
animal cell culture technology don't pose the same immediate threat to
Malee's health there are still many questions about the safety and nutrition
of these products I am confident in the quality safety nutritional value in meat
products that derive from the tissue of animals born raised and harvested in a
traditional manner I do not have the same confidence in cell culture products
and have a right to know the difference when purchasing a product labeled as
meat by law FDA and the FSIS have a responsibility to implement this
standard the federal Meat Inspection Act requires FSIS do tema meat or meat food
misbranded if it if it's labeling is false or misleading in any particular
the Federal Food Drug and Cosmetic Cosmetic Act requires FDA to deem of
food misbranded if it is an imitation of another food and is not clearly labeled
as such family farmers and ranchers have take great pride in providing a
sustainable safe nutritious food supplied with this and any food label
they want to be able to take credit for their hard work at this time consumers
want to know they are purchasing enough safe and nutritious product the bottom
line is consumers want to know and producers want to tell them thank you
thank you and with that your formal comment that great thank you very much
hi this is Sarah sorcerer from CSPI I had talked enough yesterday I wasn't
planning on giving comments today but you know the discussion over stands of
identity has been really interesting for me and I wanted to comment on that you
know first of all I say CSPI does think that there should be clarity around web
so that consumers will know whether or not they're eating sell cultured meat or
traditional meat because you know some consumers will be seeking this product
out and others really would want to avoid it and they should be able to make
that choice we had always thought of this as something that could be done
under the general authority over misleading labeling either by FDA or
USDA but I you know it's interesting to think about applying standards of
identity this you know traditionally these standards were developed to
prevent food fraud right so it was about making sure someone couldn't call
something butter when it was actually margarine and here you sort of want the
world to accomplish both things you want it to you know make sure that you people
who want to avoid this product and avoid it but also people who are seeking out
can seek it out so I don't know if it would be like I don't know what that
standard would look like would you have a minimum threshold for the percent of
the product that had to have so cultured meat in it or would you have a maximum
and say that you know or you would you say it had to be called cell based meat
if it had any of this product in it so I think in a way this is a clunky tool for
addressing the problem and also you know what would you do about existing
standards could you call it beef stew if it was cell based beef stew so I think
maybe USDA needs to look or FDA if it ends up being FDA it needs to look a
little bit beyond the standards and develop something that's more
comprehensive to address these these issues thank you very much
so again if there's anyone who has not recognized their point of view being
expressed we're quite happy to entertain additional comments here in this open
public forum or if you would like to share your formal comments early we're
happy to accommodate that as well
mmm not not seeing in it much energy here like I say we're a little bit short
on brunch opportunities here so we may make a little change in the program and
move the afternoon first afternoon set of presentations up to here unless
hearing that inspires someone to come forward with their comments otherwise
we're going to continue the session here but we'll have some additional
presentations that were originally scheduled for after lunch okay
thank you very much Thank You Malcolm and thank you to all our commenters
certainly this time is for you and so we don't want to take any of that time away
so I just want everyone to be aware that there are additional opportunities to
comment later this afternoon but let's go ahead and move with a move ahead with
the program so I'm going to ask Geoff Canavan and dr. Douglas Valentine to
come back up and we're gonna move on to the presentations on the regulatory
frameworks for food labeling claims
Geoff canavan is the Deputy Director for labeling and program delivery staff in
the office of policy and program development at FSIS and dr. Valentine he
is the director of the office of nutrition and food labeling at SIF san
and we'll go ahead and get started with Jeff's presentation first
thank you this is a tough time right before lunch so I'll try and make it
interesting so okay I think my presentations Durden
well as we pull up the presentation one of the objectives today as I wanted to
highlight some of the differences between claims whether to their
regulatory or maybe the subject of a policy and then also provide some
examples of areas where FSIS has developed some regulations and also some
policies for the use of various claims
and so some claims are defined in emphasized regulations and the big one
that I think of right off the bat are our nutrition-related we have a number
of nutrient content claims defined in our regulations relating to the good
source of nutrients good source of protein high-fiber more claims light
low-fat low-cholesterol these all have very specific regulatory requirements
that were established through public notice common and rulemaking and then
there's also claims that are not defined in regulations and that doesn't
automatically mean that they can't be used it just means that they cannot be
misleading again I think you've heard this a number of times today that all
information especially claims on labeling need to be truthful not
misleading and there's specific regulations that address that and so if
there is there's the opportunity Matthew mentioned this morning you know
provided an overview of the petitions process interested parties can petition
the agency to develop make regulatory changes which can include the
development of new claims regarding not only nutrition but anything related to
the meat and poultry so I've mentioned that evidence is in the absence of a
regulation may publish labeling guidelines which we have done in the
past and I'll go over a few specifically as examples but it's really important to
note that and I think you heard this earlier with Doug and myself is that you
know the agencies really worked closely together and so you'll see in the
development of certain guidelines we've worked closely with FDA we work closely
with agriculture marketing service on animal production raising claims and
also the Center for nutrition policy and promotion
so we don't develop these guidelines or policies in a vacuum we're certainly
collaborating with other organizations government agencies and again I want to
emphasize the consistency with food labeling policies and regulations across
all food categories is a very important consideration for the agency and so
here's an example of a policy guide that we developed we were presented with some
labels through a prior label approval system that wanted to make claims or
statements I should say about the amount of omega-3 fatty acids you know in a
product and you know this is not a nutrient that's in the nutrition facts
panel that mega threes are not specifically called out
so we developed a guideline that explained if the the the mega three
fatty acids occurring in the meat were increased through the fee the animal was
given you could make a statement we wouldn't need data that would be
submitted with that label application supports a specific level that you're
declaring but also felt that it was important if the mega threes are being
introduced in a different manner say through a particular ingredient that it
was important that the consumer know where the source of the omega-3s are
coming from and so that would be a different type of claims such as X
milligrams and mega three fatty acids from the fish oil and the breading and
so here's an example of a beef patty product that had a claim and similarly
we had a guidance document relating to Whole Grains we were presented with some
labels where a company wanted to make or highlight the fact that the breading in
the product had a certain amount of whole grains and so we were through the
policy development you know looking at potential claims we felt that it could
potentially be false and misleading if there was not a significant amount of
whole grains in the product the consumer would could potentially be misled into
thinking it was a there significant amount of that product and so we worked
with FDA and CNPP and in our guideline we established that
you know to make a statement of this type it should have a significant amount
which should be at least eight grams per serving
and so here's an example of a chicken nugget product making such a claim about
10 grams of whole wheat per serving and so with these compliance policy guides
the agencies typically will will put the guidelines out for 60 days for public
comment so they'll go out on a draft form and then ultimately be published in
a final form at that next slide
I think the roads not working here
oh here we go and moving on to other types of claims that are not defined our
regulations there's those called negative claims and it might sound kind
of not right I mean how can you make a claim that's negative but they're
negative in the sense that you're highlighting the absence of a particular
substance ingredient or class of substance like no preservatives would be
a class or no MSG or no soy and so through a prior label approval system
we're seeing a significant number of those types of claims on meat and
poultry products next slide please we've also approved statements relating
to non-genetically engineered claims it's another example of a compliance
guideline we've published it's currently in the draft for more value in the
comments but it establishes the criteria for which FSIS will approve labels for
claims of this type they're required to be under a third party certification
program and so the claim would consist about the absence of genetically
engineered feed and an animal's diet or the absence of genetically engineered
ingredients in a product the claim would also be expected to identify the
certifying entity as well as provide a website so the consumers could obtain
additional information on the specific standards that are being applied under
the third party certification program thanks a lot
and so here's just an example of a label has multiple claims raised without
antibiotics and added hormones but it also has an example of a claim about the
no GMO feed ingredients and in this case is using the USDA Organic Program as the
third-party certifying entity we've also have approved statements about the
presence of genetically engineered ingredients can be specific to a
particular ingredient or more general in cases where one or more genetically
engineered ingredients may be used I may also describe the purpose of use
another I think very good recent examples animal raising claims we've
seen a growth in this area and claims over the last 25 years recently
published a guideline that described the types of information that would needed
to be submitted with the label applications support a particular claim
such as a breed claims such as Angus raised without antibiotics grass fed
we're also under an AMS process verification program so for most animal
production claims the required documentation I think it's important to
emphasize you know as we talk about the types of documentation that emphasizes
jurisdiction starts at the slaughterhouse
so these claims are encompassing a number of raising practices that have
have occurred outside of our jurisdiction on the farms so this is why
we needed additional information such as detailed written protocol explaining the
controls in place for assuring the production from birth to harvest and
we'll have some examples here in a minute signed affidavits declaring the
specifics of the animal production claim how they were you know for example
raised without antibiotics and also tracing and segregate segregation
mechanism so if you are making a raised without antibiotics claim and you have
to treat the animal and event of illness how are you going to segregate those
animals from the from the herds and to maintain the validity of the labeling
claim of fur the rest of the animals once they're slaughtered a protocol for
the identification controls segregation and non conforming animals that was just
talking about feed formulations in the case of feed claims and certainly a
third party certifying verification claims they're going to see a copy the
certificate and so this this compliance policy guideline we received a lot of
feedback from industry you know requesting clarification on the types of
documentation so it was published in 2016 and we're currently going through
those comments and to publish that and final so one of the years that I really
wanted to discuss today is the new labeling focus on claims or evocation if
we go back rewind to 2010 or we conducted rule base
require nutrition labeling on ground single ingredient products and ground or
chopped meat there was in that final rule it talked about how FS I was going
FS eyes was going to collect samples of raw ground beef for nutrient analysis
and then in order to verify compliance with what's being declared on the label
and so the project goal for FS iOS was to do this surveillance sampling you
know it's surveillance to get an idea of are the products we sampling in
compliance and determine whether you know whether the information is accurate
or whether further testing is going to be needed and so one of the criteria for
this sampling with our labs is that there had to be consumer ready packaging
so they could do the analysis and then also compare to what is on the product
label of how the product is would being marketed in commerce and so again this
is based on there was there was ongoing concern about whether the claims being
presented make sure we have a prior label approval process but also it you
know it helps to have this post market surveillance activities to determine if
these claims are truthful non-misleading or in the case of nutrition labeling of
what's being stated on the label accurately represents the product so in
2018 we also expanded the raw ground we started sampling and we expanded the raw
ground beef sampling doubling the number of sample samples analyzed in the
laboratory and as I mentioned earlier we have seen a growth of the use of certain
claims through a prior label approval systems such as no soy negative claims
such as no or raised without antibiotics so in it so in 2018 we also expanded as
part of this laboratory surveillance sampling program to look at raw ground
beef products with negative no hormone claims raw chicken parts with negative
no antibiotics claim and radiate products with negative and no soy claims
so we'd be looking at doing continue with our nutritional analysis but then
also looking at other types of claims on these products as well and again this
was to verify used as a surveillance mechanism I should say to verify
industry's compliance with with information on the labeling being
truthful not misleading and also to determine whether the claims were also
truthful anonymously thank you good I think I stand between all you guys and
lunch so I will do my best to talk about claims I think you'll see they'll
there's a lot of commonality between how FDA views claims and and and FIS has
been reviewed some sorts of claims but there are differences in that FDA
doesn't regulate meat so we don't deal with organic and we don't deal with
hormone free and that sort of thing but we have a whole variety of other claims
including health claims that that we have to deal with so I'll spend a little
bit of time going over claims from the FDA perspective the basis of most of the
the current claims are were established in in 1990 when the nutrition labeling
and Education Act was revised that gave us authority over what we call nutrient
content claims and health claims informal health claims and well and I'll
come to it in and then because of court litigations we've also then developed
the alternative of what are now called qualified health claims and I'll discuss
each of those there are other truthful and not misleading claims that we look
at on food labeling it could be made with sea salt it could be something like
you know made with real maple syrup it could be something like you know you
know vegetables only grown by American farmers and we would look at each one of
those to make sure that in fact it was truthful and not misleading and that
that that a company manufacturing the product
could substantiate that that claim was in fact backed up by fact in science so
start with nutrient content claims and and these are this have been quite
popular on packaged food products they would be something like low in fat low
in saturated fat low in sodium sugar-free high in oak bran
those sorts of nutrient content claims that are high and low in and they're
based predominately on having a daily value or reference amount that that that
claim would be based on it also there also could be terms including free high
and low well comparative claims such as more reduced light or nutrient content
claims the regulated term healthy arm is a nutrient content claim or you could
have simple amount of percent claims which would be factual statements that
captured the amount of a particular component think when we looked at at
simple amount of percent claims a little bit like FIS we would be looking to make
sure that that that the percents were that were declared were meaningful in
terms of the nutritional and public health content con context these are
just all of the the regulations that that that provide that the detailed
regulations that describe these various claims and I won't go through them but
you can see them in the CFR 21 there's an additional claim that was established
in na la which will call for demand notifications and and that was a basis
that said in some circumstances when an authoritative body like a Dietary
Guidelines committee or do i panel it makes a certain statement
that there is considered to be scientific consensus around those
particular statements and rather than petitioning FDA for the use of those
particular claims we can be informed that based on that authoritative
statement that a particular claim health claim or nutrient content claim can be
justified because there already is general scientific agreement around that
particular claim one comment and Jeff alluded to it in labeling this morning
is that some products do not require nutritional labeling but when you begin
to make a health claim or a Content claim nutritionally labeling is then
required to go along with it so one of the the requirements of doing nutrition
based claims is nutrition facts information must then be provided with
it so the general requirements of nutrient content claims they're
generally based on nutrient levels they're generally based on what we call
wraps or serving sizes from an FDA perspective or reasonable amounts
customarily consumed that's the typical amount that consumers use and that will
be the serving size information that is on nutrition packages today one of the
the policy discussions that we've been recently discussing with FIS is that
with dual column labeling what would be the basis of those nutrient content
claims on packages now whether it would be on the larger serving size or the
traditional rack and I think we're we we believe it should stay with the the
traditional rack of those particular products and when there's a nutrient
content claim let's say a good or excellent source of vitamin D or vitamin
C iron ore protein for example if that
particular product contains excessive amounts of sodium added sugars or
saturated fat for example you'll see a disclosure statement that refers the
consumer to the nutrition facts panel to make sure that they don't think that a
product just because it has a nutrient content claim on it is is also healthy
in all aspects and to make sure that they're referred to the nutrition facts
where they can refer to the content of saturated fat or sodium for example in
order to to make sure that consumer has full information about how to judge that
how to fit those products into their their their diets nutrient content claim
healthy that's one that that's been quite popular on on food labels the
original nutrient content claim describing healthy was put into
regulation in 1994 it was based on the nutrient content of foods of providing a
meaningful amount of some of the key nutrients info in shortfall but not an
excessive amount of sodium cholesterol saturated fat or total fat for example
as you are aware we've been revisiting that definition we held a public meeting
last year to get get input around redefining the definition of healthy we
also received a citizen's petition as he has to considered a definition and we're
currently working on on how we might modernize that that definition this just
provides some of the background about the comments we got into the the public
docket I think it it it shows that the value of public comment and then clearly
one of the things that came out of the public
comment is is a desire for somehow that we take food groups into account and not
just nutrients as we consider a modernized or updated definition of
healthy and we're looking at how that may or may not be able to be
accomplished within the regulatory framework but I think those types of
comments are quite helpful to us as a regulatory agency as we strive to to do
that and the other aspect we're looking at is how could we better make sure that
modern definition of healthy is aligned and consistent with Dietary Guidelines
and and as you know USDA does a lot of work in terms of Education on Dietary
Guidelines so it's another place where we collaborate with USDA and in terms of
how can we best make sure that our labeling requirements are also helpful
in fostering the goal of getting Americans to build diet patterns that
are consistent with our guidelines
another group of claims that that were come out of Nara that that we as an
agency spend a lot of time reviewing because we have statutory authority to
approve what are called formal health claims and these are relationships
between a substance in a fluid or a food and reduce risk of a disease
relationship and that may be in the general population or it could be in a
sub population these are risk reduction claims and they're not claims that I'll
talk about the ability of any substance to reduce the risk of a disease or to
well its ability to reduce the risk of a disease but not to treat prevent cure or
mitigate an illness those are drug territory not food territories and like
I said FDA must review and authorize the use of both significant scientific
agreement claims and qualified health claims
so the general requirements for these health claims and
the petitions that would ask us to consider health claims are in 21 CFR and
it's under 101.1 for for those that want to and we we generally spend quite a bit
of time consulting with with firms that want to submit health plan petitions to
make sure that the petitions are robust and based on the best science possible
so as I said there are three types of health claims that that can appear on
food packages the strongest ones are significant scientific agreement claims
these are claims where we believe that the science is the strongest that that
really is robust in that there is general agreement among scientific
experts that the relationship between the substance and the diseases is
supported by by strong science in some cases rather as I said rather than us
reviewing the claim if there is an authoritative statement about a similar
relationship it's called Fidelma that is another path to having those claims
authorized there are some claims that have been authorized through Fidelma but
they aren't common now and then we have what are known as qualified health
claims and that is response to First Amendment considerations in the United
States and that the view that we can't prevent expression of claims that are
that are substantiated by some science but that we issue enforcement discretion
around that those claims and we we make sure that we provide appropriate
qualification as to the strength of the science that might support that
relationship when it does not meet a significant scientific agreement level
of scientific evidence so all health claims that appear have to have some
basic facts they have to have a substance that the claim is based on
that might be a nutrient it might be a food but that there clearly is a
substance it must be a disease or health-related condition and the
discussion of the relationship between those particular things for example we
have claims on the relationship between Oprah and reduce risk of cardiovascular
disease based on cholesterol reduction it's an example of a type of of health
claim a label health message that could be health messages for example dietary
guidance statements or other messages on on packages that might be related to
health that would be a truthful and not misleading claim on on packages but
those sorts of messages cannot relate between a diet and disease relationships
so for example talking about the importance of whole grains in in healthy
diet patterns would be a health type message but it would not be a health
claim and as with nutrient content claims there are disqualifying levels
for a variety of nutrients where if you exceed those you are not able to make a
health claim and that's the amount of saturated fat cholesterol sodium and
total fat or all factors that we take into account and because of the
relationship between those dietary components and increased risks of Public
Health so we put those the the regulation does allow us to to give
exceptions to some of those claims so for example we have a claim on the
relationship between eating certain nuts or olive oil and reduce risk of
cardiovascular disease and those particular nuts and seeds or oils do
contain meaningful amounts of saturated fat so because saturated fat is
naturally occurring in those foods we we give an exclusion to the saturated fat
content of those and they can still it be authorized to use the claim and those
are examples of that so I've already talked about significant scientific
agreement claims I won't go but currently there are 12 significant
scientific claims that we've we've authorized for use in foods an example
of another one is diets low in saturated fat and cholesterol made to reduce the
risk of heart disease that's another example of a significant scientific
agreement claim another one is low fat diets rich in fiber containing grain
products fruits and vegetables and they reduce the risk of some types of cancer
but it gets a little bit qualified because we say a disease is associated
with many factors so that's another example of a type of significant
scientific agreement claim and again disqualifying gluten nutrient supply so
it seems like I'm going backwards sorry pushing the wrong button okay and I've
already talked about food and that claims in saying that they are based on
authoritative statement so an example of one of those is diets containing foods
that are a good source of potassium and low in sodium may reduce the risk of
high blood pressure that's an example of one of the authorized claims that came
from fed Anna so then I'll come to qualified health claims and these are
the more typical claims that we as an agency are authorizing via enforcement
discretion a rather than significant scientific agreement claims simply
because the level of evidence for a significant scientific agreement is a
very high threshold so the qualified health claims must be supported by
scientific evidence but they're below significant scientific agreement we
authorize them through enforcement discretion letters where we specify
specific claim language and we also qualify the the level of scientific
support for the relationship of the claim for example an example of one
would be supportive but not conclusive evidence or research shows that eating
1.5 ounces per day of walnuts as part of a diet low in saturated fat
and low in cholesterol not resulting an increase in caloric intake may reduce
the risk of coronary heart disease and when their we say see nutrition
information for fat and calorie content so it's quite a mouthful but but those
are the types of claims that we will consider authorizing under qualified
health claim requirements other claims and statements can be put on packages so
long as they're truthful and not misleading and I think we we heard some
comments this morning about production methods
you see claims on packages now that talk about not made with bioengineered foods
so you see some of those particular claims that are used on packages we have
claims around yet gluten-free grown on a family-owned form for example so there
are a variety of those sorts of claims that can be put on packages that that
marketeers can do on a voluntary basis and we we judge them based on whether
whether they're truthful and not misleading and for food for further
information we have a food labeling guide that that really provides a lot
more information about claims so thank you
thank you so much so that does conclude our presentation portion for today but
we won't have an opportunity this afternoon to hear from you again as you
can make open public comment and we will round out the day with a formal public
comment session so right now I think we're going to break for lunch let's
meet back here at 12:30 and we'll begin the next open public comment session as
a reminder the USDA cafeteria is in a wing 3 and they do have quite a lunch
selection there so please enjoy yourselves
thank you
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