An Expert’s Insight & Tips on Facing FSSAI/FDA Audits
Sr. No. Index Pg. No.
1. About the Author 2
2. Chapter 1: What is FSSAI, FSSA & FSSR ??? 3
3. Chapter 2: Offences & Penalties under the Act, 2006 6
4. Chapter 3: Powers of FSSAI 11
5. Chapter 4: Rights of a Food Safety Officer (FSO) 13
6. Chapter 5: Rights of the Consumer 15
7. Chapter 6: Rights of the Food Business Operator 18
8. Chapter 7: What should you do in case of a 20
Complaint?
9. Chapter 8: Types of Audit 26
10. Chapter 9: Preparation Before an Audit 28
11. Chapter 10: How to Face a FSSAI / FDA Audit 31
12. Chapter 11: Post Audit Actions 33
13. Conclusion 35
About the Author: Ashwin Bhadri is the Head of Business
Relations for Equinox Labs. He is a Graduate
from University of Austin, Texas. He Majored in
Chemistry and Computer Science and followed
by an MBA in Marketing.
He is also a Certified Food Auditor and has
completed the Global Food Safety
Management Program from Cornell University.
For the last 9 years he has developed his Expertise in Hygiene &
Food Safety. He works with many top brands to help them develop
Food and Water Safety Programs and Corporate Compliance Policies.
He has been featured in many Newspapers and News Channels.
He has trained over 10,000 people on Food Safety Implementation
and FSSA Compliance. He consults over 500 Companies on Food
Safety Compliance and Employee Health and Safety.
For more information visit: http://in.linkedin.com/in/ashwinbhadri
Chapter 1: What is FSSAI, FSSA & FSSR?
By now, I believe every Food Business Operator (FBO) in the
country must have acquainted himself with FSSAI (Food Safety
Standards Authority of India), the regulatory body governed by the
Ministry of Health & Welfare that is responsible for implementation
of Food Safety & Standards Act (FSSA), 2006 in India. I understand
that this book is more on 'How to deal with Food Safety Officers
(FSO) who would audit your facility' & how to understand the audit
process in general but, it is also essential to understand the body that
governs you, its powers, the rights that you have as a FBO, the rights
of an FSO and the Consumer. So, the first few chapters would actually
be a prelude to the actual crux of the matter.
The Food Safety Standards Bill was passed on the 23rd
August 2006
by the parliament. As we are all aware that initially an Act is known as
a Bill & only once it has been passed by the parliament, it comes to
be known as a law that needs to be abided by. This Act also aims to
establish a single reference point for all matters relating to food
safety and standards, by moving from multi-level, multi-
departmental control to a single line of command. To this effect, the
Act establishes an independent statutory Authority – the Food Safety
and Standards Authority of India with head office at Delhi.
The Government of India established the body as mentioned earlier
under Food Safety & Standards Act, 2006 known as the Food Safety
Standards Authority of India, which we all know as FSSAI. Food Safety
and Standards Authority of India (FSSAI) and the State Food Safety
Authorities shall enforce various provisions of the Act. The
Chairperson and Chief Executive Officer of Food Safety and Standards
Authority of India (FSSAI) have already been appointed by
Government of India. The Chairperson is in the rank of Secretary to
Government of India.
FSSAI was created with the aim of to lay down standards based on
science to regulate all FBO’s involved with food or beverage, viz.,
manufacturers, relabels, importers and businesses dealing with
storage, transportation, sale & distribution of any kind food. Basically
everyone in the food chain.
The Act goes on to take under its purview various Central Acts like
Prevention of Food Adulteration Act, 1954, Fruit Products Order,
1955, Meat Food Products Order, 1973, Vegetable Oil Products
(Control) Order, 1947, Edible Oils Packaging (Regulation) Order 1988,
Solvent Extracted Oil, De- Oiled Meal and Edible Flour (Control)
Order, 1967, Milk and Milk Products Order, 1992 & any other order
issued under the Essential Commodities Act, 1955 (10 of 1955
relating to food). What this means is that you no longer have to go
through the pain of obtaining multiple licenses if you fall under any of
these Acts. However, the Weights & Measures Act, 1976 still remains
solely by itself and does not come under the purview of FSSAI.
The Food Safety & Standards Authority of India introduced the Food
Safety & Standards Regulations (FSSR) in 2011 which brought the
entire law into effect, making it mandatory for every FBO to procure
a license, depending on their annual turnover. The licensing system
was further split into Central & State, again depending on the annual
turnover & production capacity. Through this the FSSAI decentralized
its powers to State Level making it easier for its implementation.
Chapter 2: Offences & Penalties under the Act, 2006
When I first read this part of the law, I couldn’t help but
recollect some infamous people and the incidents that led to it, viz.,
the Panipuri “Pee-in-puri” incident, IIT- Powai food poisoning. I
remember that the penalty imposed on the Panipuri vendor was a
mere night behind bars & a fine of Rs. 1,000, & in the case of the IIT
incident, the caterer was suspended only to be probably recruited
back again or to find himself working elsewhere. Today with the
addition of the imprisonment clause in case of any violations of any
of the provisions of the Act, FBO’s are more cautious.
While deciding the quantum of penalty, the Adjudicating
Officer or the Tribunal, as the case may be, shall take the following in
to consideration:-
(a) The amount of gain or unfair advantage, wherever quantifiable,
made as a result of the contravention. For instance – In case a milk
supplier adulterated the milk before he supplied it to various sectors,
the profit that he individually & the profit he gained through the
other sectors would be quantified and the penalty would accordingly
be imposed.
(b) The Amount of loss caused or likely to cause to any person as a
result of the contravention,
(c) The repetitive nature of the contravention,
(d) Whether the contravention is without his knowledge, and
(e) Any other relevant factor,
OFFENCES PENALTIES
Substandard food Fine that may extend to 5
lakhs
Misbranding Fine that may extend to Rs. 3
lakhs
Misleading advertisement Fine that may extend to Rs. 10
lakhs
Food containing extraneous matter Fine that may extend to Rs. 1
lakh
Any non compliance with the Penalty not exceeding 2 lakhs
provisions of this act and regulations
or as directed by the FSO
Unhygienic / Unsanitary conditions Fine that may extend to Rs. 1
lakh
Possession of Adulterant not injurious Not Exceeding Rs. 2 lakhs
to health
Possession of Adulterant injurious to Not exceeding Rs. 10 lakhs
health
Contravention of any of the Fine may extend to Rs. 2 lakhs
provisions of Act for which a penalty
is not defined
Unsafe food but does not cause 6 months imprisonment with
immediate injury a fine of Rs. 1 lac
Unsafe food causing non- grievous 1 year imprisonment with a
injury fine of Rs. 3 lakhs &
compensation of up to Rs. 1
lakh in case of injury.
Unsafe food causing grievous injury 6 years imprisonment with a
fine of Rs. 5 lakhs &
compensation of up to Rs. 3
lakhs in case of grievous
injury.
Interfering with seized goods Imprisonment that may
extend to 6 months with a fine
that may extend to Rs. 2 lakhs
Providing any false information Imprisonment that may
extend to 3 months & a fine
that may extend to Rs. 2 lakhs
Obstructing or Impersonating an FSO Imprisonment that may
extend to 3 months & a fine
that may extend to Rs. 1 lakh
Operating without a license Imprisonment that may
extend to 6 months & a fine
that may extend to Rs. 5 lakhs
Well, I don’t want to scare you but caution you against what you
can be pulled up for. Having said this, it is equally important you
know your rights, the rights of the FSO & consumer so that you not
only safeguard yourself, but are informed about the law & system
that governs you.
Chapter 3: Powers of FSSAI
FSSAI has been mandated by the FSS Act, 2006 for performing
the following functions:
- Formulate the regulations to lay down guidelines so that a
certain set of standards can be enforced equitably across all
sectors. The guidelines have been devised keeping in mind
the standards followed globally.
- Guiding & providing procedures for the accreditation of
certification bodies that certify food safety management
systems of various food businesses.
- Laying down procedures and guidelines for accreditation of
laboratories and notification of the accredited laboratories.
- To provide scientific advice and technical support to Central
Government and State Governments in the matters of
framing the policy and rules in areas which have a direct or
indirect bearing of food safety and nutrition.
- Collect and collate data regarding food consumption,
incidence and prevalence of biological risk, contaminants in
food, residues of various contaminants in foods products,
identification of emerging risks and introduction of rapid
alert system.
- Creating an information network across the country so that
the public, consumers, Panchayats etc receive rapid, reliable
and objective information about food safety and issues of
concern.
- Provide training programmes for persons who are involved
or intend to get involved in food businesses. - Contribute to the development of international technical
standards for food, sanitary and phyto-sanitary standards.
- Promote general awareness about food safety and food
standards.
Chapter 4: Rights of a Food Safety Officer (FSO)
Before you actually understand the audit process, I think you
should be informed about what are the rights the FSO (or food
inspector / auditor) in order to protect your interests. Clause 38 of
the FSS Act, 2006 enlists the rights or as stated the functions of the
FSO.
- Collection of sample of any food that is in contravention
of the provisions of the Act
- Inspect your premises
- Reimburse the cost of the article of food taken from a
consumer for testing shall be paid at which it was sold to
him.
- Destroy any article of food that has been seized if found
to be unfit for consumption
- Issue a notice for an inspection by a police officer (with a
search warrant)
- Give a notice in writing of his intention
- Request the FBO to provide sterile bags or containers for
collection of samples, if necessary
- The sample will be correctly marked & sealed and the
signature/thumb impression of the FBO taken.
- The sample will be divide in 4 parts
1 part to the Food Analyst
2 parts to the Designated Officer (safe custody)
1 part to the Accredited Laboratory (on request of the FBO)
- In case the results of the both laboratories varies then a
sample from the Designated Officer will be sent to a Referral
laboratory and those results will be considered as final.
- The Designated Officer has to submit the sample for analysis
within 1 day.
Understanding your rights as an FBO also goes hand in hand with
what I have discussed above and this will be discussed in the
upcoming chapter.
Chapter 5: Rights of the Consumer
Consumer is King!!! Customer is King!!! This is very true for all
businesses. For a Food Business Operator, the Consumer & the
Customer should not be considered a King…. But a GOD! You need to
take as much care of the Consumer as you would take of your deity.
The new law empowers your Consumer with a lot of Power.
He has the right for Safe and Wholesome Food. If he doesn’t get
Safe and Wholesome Food, he has many tools at his disposal to
ensure that the Food Business Operator that didn’t give him his
right, gets punished.
The Consumer has the following tools at his disposal:
1) FSSAI Hotline: This is a hotline run by FSSAI where a
Consumer can call and register a compliant anywhere in the
Country. FSSAI will note his complaint and pass it along to
the local enforcing body to investigate.
To make this even better FSSAI runs a Reward Scheme, that if
the Consumer who registers a complaint, and it is found to
be true, then the Consumer will be rewarded Rs. 500. Don’t
think of quitting your day job and start registering complaints
for a living just as yet, because, if FSSAI finds you abusing this
rule for personal gain, you could be penalised Rs. 1,00,000/-.
2) Local FDA: The Consumer can also lodge a complaint with
the local FDA, which will trigger a visit or a raid based on the
nature of the complaint.
3) Media: This is a very powerful tool which can be used by the
consumer. Media is always hungry for news that its readers
would love to read. If a Consumer finds a worm in your
food, and if decides to go to the media, then you will have a
long month ahead of you, trying to convince your customers
that your food is worm free. Remember one thing about
Media; it’s a double edged sword. If it can make you
famous, it can also make you bankrupt. So tread very lightly
when a consumer is threatening to go to the Media.
4) Consumer Guidance Society of India: This is also a tool
available to the consumer. If your case is taken to them, they
do have a lot of influence in the government and can become
a big problem for you, if you have done something wrong.
The Consumer has become more powerful than ever before
and your need to understand that and respect that. In the years to
come you will perceive the Consumer as a much bigger threat to your
business than FSSAI or FDA.
Chapter 6: Rights of the Food Business Operator
Now that you have read about the rights of the FSO and the
Consumer, I want you to know your rights. This is very important,
because if you don’t know your rights, people can take advantage of
that.
Firstly when a person comes to audit or inspect your
premises and he tells you that he is from FDA or FSSAI or any other
local body, ensure that you ask him for an ID card. Please check this
carefully but respectfully.
Once you ascertain the auditor is genuinely from FSSAI or FDA,
and then let him continue the audit. During the Audit all the Non
Compliances that get raised, can be discussed at the end of the audit. If
you think that your process is right, you can try to make him see your
point of view. If you can prove to him that your way of doing things can
keep the food safe, he may remove that Non Compliance.
You should show him only relevant records. In case he asks
you your turnover or any other sensitive data, you will need to show
him only one piece of documentation that satisfies that criteria. You
don’t have to open up all your books to him. Also while showing him
records; he has the right to see records which are pertinent to food
safety and FSSAI Compliance. He can’t ask you to for records which
don’t have anything to do with food safety or FSSA Compliance.
When he raises Non Compliances, which he will, do ask
him against which clause that Non Compliance is being raised
against. This will force him to ensure that he is raising the right
number of Non Compliances.
When a Customer comes to you with a Complaint, if you
think that there is something fishy, you can ask him to produce a
receipt, to prove that he has actually purchased your product.
Before asking him about this, please ensure that you do issue a
receipt or a bill with every purchase.
The Last but not the least, is your right to Recall food. In
case you find out that your food is tainted, you have the right to
recall it. You need to be sure what will trigger a Recall. Do ensure
that your Food Safety Management System (FSMS) plan has a Recall
plan attached to it, so as to ensure that when you need to recall
your product, you have all the procedures, protocols and formats in
place. You may never need to use this, but it is best to be prepared.
It’s like buying Life Insurance, you hopefully never need to use it
immediately, but it is always better to have it.
Chapter 7: What should you do in case of a Complaint?
If you are lucky the complaint comes directly to you, and
does not go directly to the Authorities.
When the Customer Complaints to you, you are in the best
possible position to close the complaint satisfactorily and
discreetly. You will get 3 types of Complaints.
1) Minimum Risk Complaint: This is the best kind of
Complaint that you will get. It is something minor like:
- Hair in Food
- Stone in Food
- Water smells funny
These Complaints need to be handled quickly and closed
on the spot. Ensure that your staff is trained to appease
the Customer, so that he doesn’t create a scene or
launch a Complaint with FSSAI / FDA or worse … Media.
This kind of complaint should be closed by offering that
particular item / dish for free, a certain discount on the bill
or a free dessert. Ensure that your staff is empowered to
take these decisions and also ensure that these small
complaints get noted and a root cause analysis is done.
Even a small matter should be discussed with the
staff internally and a permanent solution should be
implemented so as so to ensure that it doesn’t repeat
again.
Things NOT To Do
Never argue with the Customer about the matter. That
will only make the matter worse for you.
If a Customer Complaints, you should in an apologetic
manner, let them that it will be looked into immediately. If
there is a GAP, then offer a complementary dish or
discount or dessert, which ever fits.
2) Moderate Risk Complaint: This is a more serious
complaint and should be handled by the Owner or a
senior member of the Business. The Complaints would be
like:
- Food Poisoning
- Dysentery or Diarrhoea
- Vomiting
If a Customer calls or visits you and tells you that they
experienced any of the above symptoms after eating at
your location or taking away food from your location,
you need to address it seriously.
Step 1: Note down their complaint. Ask them which
food item they consumed and when.
Step 2: If that batch of product is still in your location,
draw 2 samples of the same and have 1 sample sent to a
NABL Accredited Lab for Food Pathogen Testing. The 2nd
sample should be labelled correctly and stored in a
refrigerator.
Step 3: When the food testing results come back, check
if the sample failed. If the sample passes, do let the
Customer know about it. If the sample fails, you need to
inform the Customer about it and offer a small
compensation. Please ensure that this is a monetary
compensation and not a meal voucher or a free meal at
your location. (Would you want to eat at a place where
you got food poisoning??? I know I wouldn’t… and I
haven’t)
Note: If you get more than 1 complaint about a particular
batch of food, or a batch with a common ingredient, then
you may want to initiate a Food Recall. (Read Chapter 6).
3) High Risk Compliant: This type of complaint should
be handled by the Owner for the Company. These
Complaints would be :
- Customer is Hospitalised due to Food Poisoning
- Customer dies from Food Poisoning (Rare
but possible)
In case a Customer complaints, that due to eating at your
location or your food product, they had to be hospitalised
or their near and dear one died from food poisoning, then
you going to face a whole new level of trouble.
Here are the following steps which you need to take
immediately.
1) Get a Lawyer: Yes, you will need to get yourself a good
lawyer, someone who has experience in Food and Food
Safety Laws. There is going to be a case which you will
have to fight. You will have to prove your innocence (if
you are innocent that is). The new law will put the onus
of proving that all required food safety norms were
followed during the preparation of the food, unto
the Food Business Operator. 2) Get all Food Safety Documents Ready: You will be
having some documents related to your food safety
process with you. You need to start compiling them
together. This will act as evidence in court. In case you
are not sure about this, please hire a Good Food Safety
Consultant immediately, who can help you with this. This
is a very crucial step, as these are the only documents
which will help prove that you were following Food
Safety Practices. The documents will include your FSMS
Plan, Storage Records, Temperature Records, Cleaning
Records, Health Check up Records, Food Testing Report,
Water Testing Reports, GAP Audit Reports, Pest Control
Records, Training Records, etc.
3) Get the Samples Tested : The Samples that you received
a Complaint about, should be drawn by a external 3rd
Party Lab, in duplicates and one batch of it should be
sent for testing to a NABL Accredited Lab for Food
Pathogen Testing. The 2nd
set of samples should be
labelled correctly and stored in a refrigerator. If these
samples pass, then they become a great piece of
evidence which help your case. But if these samples fail,
then you will have to evaluate the option of going for
an out of court settlement with the Customer.
Note: We normally recommend that if you are not at
fault, then you should fight the case, because you will
win it, but if you do not have adequate evidence,
then you should go for an out of court settlement.
Chapter 8: Types of Audit
There are 3 types of Audits:
1) Scheduled Audits: These are audits in which the FSSAI or FDA
will inform you about the day and time when the Audit
would take place. This rarely happens, but the Government is
working to ensure that over sometime, most of the regular
audits would be scheduled.
2) Unscheduled Audits: These are the audits in which the FSSAI
or FDA officer shows up at your doorstep, unannounced. This
is what normally happens in India, as there is a lack of Food
Safety Officers, so they will visit one area at one time. The
downside of this is that there is no time to prepare your
documentation and your premises for the audit.
The above 2 types of audits are normally done once a year to
ensure that you are complying with all food safety and FSSAI
norms.
3) Raids: These Audits or Raids are based on a specific
complaint or trends in adulteration known to FSSAI / FDA.
When a Customer / Consumer complaints to FSSAI or FDA
about a malpractice or food safety violation done by a FBO,
this gets recorded and must be investigated. Based on the
seriousness of the Complaint, the time frame of action is
decided by FDA. If the Complaint is minor, like piece of
plastic found in bread, it may not trigger a Raid. But if 5
people lodge a complaint saying that they all eat at a
particular joint and have fallen ill, or if they find worms in
food, etc, this will definitely trigger a Raid. Let’s just hope
that this is not something that will ever happen to you, but
its best to be prepared for it.
Note: A Raid if not published, may not hurt you as much,
but if it gets media attention and if you are a bigger brand,
this will hit you hard, very hard!!! You will have to create a
disaster recovery plan to ensure that your brand name
doesn’t get affected in the long term. You will need to hire a
professional in handling this, so it doesn’t affect your
business in the long term.
Chapter 9: Preparation Before an Audit
Before you prepare to face an audit, you should know what
the auditor is going to look for. The auditor will look at the following:
1) Infrastructure: The Auditor will look at the Infrastructure
provided by you for the Storage, Preparation and Serving
of Food. The Auditor will see the following:
- Walls, Ceilings, Floor: Are they Clean? Are they
Cracked? Do they need immediate repair? Are there
any pests? Are there any problems which can lead
to food safety being compromised?
2) License: The Auditor will look at your license copy and
ensure that it is up to date and the right kind of license.
He will check what kind of business you are into and in
what capacity, and will check if your license reflects the
same. He may also ask you for other business related
licenses and ensure that they are also OK. You need to
ensure that all your licenses are up to date.
3) Documentation: The Auditor will also check your FSMS
Plan, and ensure that it covers all the areas required. He
will also check if you are following all the points in the
FSMS Plan. FSMS plan is the first document that every
FBO should have as it lays down the foundation for any
Food Safety Related Activity. The Auditor will also check
if you have all the other food safety related records like
food temperature record, critical storage temperature
records, training records, material storage record,
wastage record, pest control record, etc. These records
need to be up to date and filled by the right person. You
don’t need a highly educated person filling these records,
it just that they must be filled.
4) Process: The Auditor will study the process of food
storage, preparation and serving or dispatch. The
following points would be looked at:
- Raw material receiving
- Raw material quality control and storage
- First In First Out (FIFO) for Stored Items
- Preparation Process
- Control points for Sanitization and Temperature
- Post Cooking Storage
- Dispatch or Serving Process
- Left Over Storage Process
- Recall plan (If needed)
- Complaint Handling, etc
5) People: In any business the quality is controlled by the
people in the process. The Food Business is no exception.
At every Stage it is the people that control the Quality of
the Food Produced. The Auditor will check if they are
aware of basic food safety norms. He may either do that
by talking to them or by observing what they are doing.
He will also ask for the health certificates of all the
people working in your location. This is mandatory as per
the new law and needed as the food handler can easily
pass on a disease or infection through the food to its
recipient.
Now that you know what the auditor will look for you can
be better prepared to handle the audit.
Chapter 10: How to Face a FSSAI / FDA Audit
Now that you have prepared to face the audit, the
process should be pretty simple.
Before the audit starts, always find out what is the purpose
of the audit. Is it a regular check, or did they receive a complaint.
Because if FDA conducts an Audit or a Raid due to a complaint, they
will look more aggressively for compliance, as there was an active
complaint.
During the Audit always be very patient with the Auditor. If
he raises any non compliance, make a note of it promptly. Always
assure him that you will get it fixed immediately. Every Auditor will
give you advice on what needs to be fixed. If he thinks it’s a big
food safety hazard, he will mark it as a Non Compliance. But if it
doesn’t directly affect food safety, he may put it down as an
observation or he may just mention it to you.
The Non Compliances raised should be against a clause in the
Law. If you think that the auditor is being unfair, then you can ask
him, during the course of the audit or at the end, against which
clause he has given a Non Compliance. This is your right, but I don’t
personally believe in arguing with the auditor about this, as this may
push him into looking deeper into your audit, which will not end
well for you. If he really decides to go very deep, he will find at least
20 gaps in your system and penalise you for all of them.
The Law says that when the auditor finds a small gap for
the first time, he should issue you an improvement notice. If you
don’t comply with the notice, then a penalty would be applicable.
Chapter 11: Post Audit Actions
Congratulations! Your Audit is now complete. But don’t
celebrate yet. After every audit you will have to make a list of all the
improvements you need to bring in your organisation and in your
process to ensure that the audit process is smoother the next time.
During every audit many gaps are discovered either by you or they
are made evident to you by your auditor. These gaps need to be
closed within a certain timeframe so as to ensure that your end
product stays safe.
After every audit you have 2 outcomes.
1) You have passed the audits without any Non
Compliances.
2) You have received Non Compliances.
In the first case you need to spend time with your team
and understand improvement points and the timeline to
implement them.
But in the second case you need to take more serious and
immediate action. Whether the audit is by FDA / FSSAI / Internal
Auditor or a 3rd
party Consultant, you need to take the audit findings
more seriously and ensure that the Preventive and Corrective
Actions are taken quickly and correctly.
I have seen so many FBOs facing an Audit, learning a lot from
the process, but not acting on it.
“Experience is a good school. But the fees
are high.”
In my experience the best way to ensure all this happens is to
allocate each corrective action to a team member and also give him a
time frame to finish it in. Then review on a regular basis to ensure
that the progress is on track.
Over many years of auditing and implementing food safety
systems across the country, I have found the key, the secret of success.
If you want a Food Safety plan to work, you must have 1 single person
in your organization to take charge of this. If there is a single point
responsibility then things get done. If that person knows that if this
doesn’t get done, he will lose his job, then it gets done.
Conclusion
I think the reason I was inspired to write this book was
that I learnt post the release of my earlier book “13 Steps to Protect
yourself from the Consumer & Regulatory Authorities” that it wasn’t
enough help given to the FBO, who always stands in the line of fire.
Hence, I thought it would be best to armour him still further through
this book. After all, “Ignorance is not always blissful.” I would like to
sign-off with a very thought provoking quote.
“Knowledge & Human Power are synonymous, since the
Ignorance of the Cause Frustrates the Effect.”
- Francis Bacon
To know more about Complying with FSSAI Standards, you can
reach me on [email protected]
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