FSMA Requirements for Grain Businesses

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Food Safety Modernization ActFocus: Grain Quality and Tracking


Food Safety is a big dealEvery year, 48 million people get sick from foodborne diseases.

That’s one 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

PREVENTIONinstead of REACTION.


How does FSMA work?

Preventive controls and regulations to stop intentional contamination, and catch naturally occurring hazardsInspection of some facilities FDA access to recordsMandatory recalls if contamination happens and a company doesn’t start a voluntary recallEnhanced tracking and tracing record-keeping


How does FSMA affect grain businesses?

Even though grain businesses are technicallyexempt 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 trainingFacilities and groundsSanitary operations, facilities and controlsEquipment and utensilsProcesses and controlsWarehousing and distribution

Source: Dr. Angela Shaw


TrainingEmployees 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 ControlsControls 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 manage the plan. Plan manager must follow Good Manufacturing Practices.


Preventive Control Plan Gatherinfo

Analyze data

Improvement

CustomerSatisfaction

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 have to formulate procedures. No need to reinvent

the wheel.• Must have training 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 arisesProcess 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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