FSMA Requirements for Grain Businesses

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Food Safety Modernization Act
Focus: Grain Quality and Tracking

Food Safety is a big deal
Every year, 48 million people
get sick from foodborne
diseases.
That’sone out of every six
Americans.
128,000 people are
hospitalized.
3,000 people die.
Statistics from the Food and Drug Administration

COULD THE U.S. FOOD SUPPLY BE
INTENTIONALLY CONTAMINATED?
After the September 11th attacks in 2001, concerns intensified. The
food safety issue expanded to include the question…

Researchers found the short answer: YES.
To increase safety, the
Public Health Security and
Bioterrorism
Preparedness and
Response Act was created
in 2002.
FSMA was signed in 2011
to begin the enforcement
process, focusing on
PREVENTION
instead of
REACTION.

How does FSMA work?
Preventive controls and regulations to stop intentional
contamination, and catch naturally occurring hazards
Inspection of some facilities
FDA access to records
Mandatory recalls if contamination happens and a
company doesn’t start a voluntary recall
Enhanced tracking and tracing record-keeping

How does FSMA affect grain businesses?
Even though grain
businesses are technically
exempt from FSMA
regulations, if the FDA
believes food is tainted in
any way, it can stop
production.
If you’re in the customers’
supply chain you’ll have to
provide records – within 24
hours.

“Wait! My elevator is exempt, right?”
Don’t buy that!
Customers expect you to establish some protocols on
food safety anyway, so the exemption is “in name only."
Elevators handle commodities delivered by many
growers.
– You have minimal quality control over the growers.
It’s up to you to know about the grain in your facility.
Source: Dr. Charles Hurburgh, Iowa State University

Expert advice at GEAPS
Dr.Angela Shaw
Assistant Professor at Iowa
State University spoke
about:
– Good Manufacturing
Practices
– Training
– Preventive Controls

Good Manufacturing Practices Involve…
Personnel and training
Facilities and grounds
Sanitary operations,
facilities and controls
Equipment and utensils
Processes and controls
Warehousing and
distribution
Source: Dr. Angela Shaw

Training
Employees at facilities that manufacture, process, pack
or hold food should be qualified to perform their duties.
– Knowledge can come from education, training or experience.
Should include principles of food hygiene and safety –
– Maintaining cleanliness to avoid contamination
– Hand-washing,unsecured jewelry, clothing, etc.
Training must be documented.
– Date, type, individual trained

Preventive Controls
Controls must be validated to make sure those you’re
serving won’t get sick or die.
Records should be kept and reviewed, especially to
know what should happen if an emergency arises.
An auditor – an employee, hired expert or consultant –
will ensure preventive controls are maintained.
– Must have auditing experience
– Should be FSMA-accredited

Expert advice at GEAPS
Dr. Charles Hurburgh
Professor at Iowa State
University spoke about:
– Developing a Preventive
Control Plan
– Basing the plan on Quality
Management Systems
– Hazards
– Procedures

Preventive Control Plan
Your qualified employee will managethe plan.
Plan manager must follow Good Manufacturing Practices.

Preventive Control Plan Gather
info
Analyze
data
Improvement
Customer
Satisfaction
Plan should be based on the
principles of quality management
systems:
• Structured way of doing
the things the same way
each time, consistently.
• Traditional focus of
quality management is
customer satisfaction,
but it’s easy to add
compliance to regulatory
and food safety into the
objectives
• Always must have
objectives – short, clear,
documentable, less than
a page, trainable in 5-10
minutes.
LOGIC
CIRCLE
OF INFO
Source: Dr. Charles Hurburgh

Criteria for designing
procedures
• Understand the facility –
Which activities happen?
What are the processes?
• This can help you see
where food safety issues
might develop.
• Identify whether you’re in the
supply chain documentation
for your buyers.
• If so, you’re just as
involved in FSMA as the
feed mill or processing
plant that’s buying your
grain.
• Get a good flow diagram of
the facility.
• Identify transfer points
and places where
hazards can either come
in or be taken out.

What are hazards?
• Physical hazards – foreign
material in grain
• Naturally occurring – mycotoxins,
disease, decomposition
• Most hazards are naturally
occurring.
• Chemical hazards – treated seed,
antibiotic residue in by-products,
allergens
• It may be unclear whether
your grain will be for human
consumption, so trace
amounts of wheat and
soybeans should be
considered allergens in
other grains.
• Cross-contamination
should be minimized.

Writing procedures isn’t complicated, but it should be disciplined.
• Decide which operations are important and affect food safety.
• Establish a standard procedure for those operations.
• When you identify procedures you know make a difference, get people
thinking in organized ways about the procedures.
• Start at the operations level, not with broad objectives.
• Use data you already haveto formulateprocedures. No need to reinvent
the wheel.
• Must havetraining documentation.
• Diagrams are very helpful.

Every procedure should have:
A reason An objective
Clear, simple
process
Way to
measure
success
List of things
to do if a
problem arises
Process for
training

Bottom line:
Know your facility and write simple, clear
operating procedures that meet multiple needs
simultaneously for both grain quality and food
safety.

If a recall happens, could you furnish
information for reporting within 24 - 48
hours?

Yes, IF....
…you have a binning system
that tracks where your grain
came from, where it goes in
your facility and where it ships.
The system also should
capture key information,
including grain quality.
Do you have a system like this?
FSMA is near for you and your
buyers.
You need one!
Contact us for more info!

FSMA Requirements for Grain Businesses

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FSMA Requirements for Grain Businesses