What You Need to Know About the Food Safety Modernization Act

We work in an ever evolving industry.  Evolving with technology, and evolving for the consumer demanding transparency and trust in the food they bring home to their families.  Food Safety has an increasing influence on consumers.  Understandably, they want to trust that their food is safe and was raised responsibly.  Enter PQA, the Common Swine Industry Audit, and soon to be the Food Safety Modernization Act (FSMA).

What’s the Food Safety Modernization Act?

Many producers are unfamiliar with FSMA.  Signed into law January 4th of 2011, the FDA has been continually working on the Proposed Rule – fine tuning and tweaking until the final rule was published in September of 2015.  With upcoming changes influencing feed mills, producers are keeping a close watch.

Dr. Joel DeRouchey of Kansas State University joined Pipestone Grow Finish clients in February and presented information assembled by Dr. Cassie Jones also of K-State for an overview of FSMA and how it will impact feed mills in the upcoming year.  Dr. DeRouchey sums up the goal of FSMA. “[FSMA] aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.”  A goal both consumers and producers can get behind. The regulation has two key parts:

1)      The Current Good Manufacturing Practice (CGMP) requirements to ensure feed is being manufactured in accordance with new CGMPs, and

2)      The Hazard Analysis and Risk-Based Preventive Controls requirements (HARBPC) to develop a food safety plan to identify and minimize human and animal food safety hazards.

Dr. Joel DeRouchey highlighted the following points in his presentation:

When will this go into effect?

compliance dates


millWho must comply?

1.  All registered facilities (manufacturers, processors, packers, or holders of animal food.)  The individual ultimately responsible for compliance is the owner, operator or agent in charge of the facility (feed mill).

2.  Farms that meet the ‘primary production farm’ or ‘secondary activities farm’ definition don’t need comply with any part of FSMA.  Most smaller swine producers with their own mill would meet the definition of farm if they only supply feed to their own animals. However, a producer who owns or manages a feed mill and either utilizes contract growers or manufactures feed for another producer would not meet the exemption, and must comply with all parts of FSMA.

3.  Facilities with less than $2.5 million in total annual sales need to comply with Current Good Manufacturing requirements, but do not need to comply with the HARBPC requirements.

4.  All mill employees engaged in the manufacturing process, including maintenance and housekeeping, will need to meet the definition of being a “Qualified Individual,” meaning they have had training on animal food hygiene and safety, including the importance of employee health and personnel hygiene.

5.  Feed safety at each mill will be under the direction of a “Preventative Controls Qualified Individual.”  This person is not required to be at the facility (they could be at a corporate office or another mill), but it is recommended. Watch for training sessions beginning in June 2016.  HACCP training alone will not be sufficient.

What facility changes are necessary to comply with CGMP requirements?

The CGMPs are observable practices that an inspector would be able to see, and typically do not require documentation. Some examples include:

  1. Required handwashing, no jewelry
  2. Shatterproof lights
  3. Clean so as not to encourage pests
  4. Water that is safe for use
  5. Brooms and equipment in sufficient condition so as not to be a source of contamination
  6. Control of rework and flushes
  7. Inspection of bulk vehicles prior to loading

Documentation and Preventative Controls

Although most of these safety checks are already in place at feed mills, Dr. DeRouchey said there will be a greater focus on documenting preventative controls on things like below:

  1. Layout the process flow and products produced
  2. Identify hazards that may occur within each end product
    a. What hazards should you consider?
    i. Physical – metal, rubber, plastic, wood
    ii. Chemical – chlorinated pesticides, drug carryover, mycotoxins, nutrient deficiencies or toxicities
    iii. microbiological – PEDV
  3. Evaluate the severity and probability of those hazards, and provide written justification for that evaluation.   a. Measures, such as biosecurity plans and mycotoxin monitoring plans, that reduce the probability of hazards ocurring may be considered when evaluating probability
  4. Create a control plan for hazards that have a high probability of occurrence and would have a high severity if they were to occur. a. Develop documentation, monitoring, corrective actions, verification, validation to ensure the controls are effective
    b. Many facilities may not need this step if sufficient measures are implemented in Step 3a.
  5. Develop a recall plan for hazards in Step 4 (it is recommended you complete this step even if there are no hazards in this step)

What should you do in the meantime?

  1. Determine if you are exempt from any part of the rule; and if so, gather documentation for that exception.
  2. Determine whom in your operation should be a Preventive Controls Qualified Individual and make sure they attend an FSPCA-certified animal food course (offerings beginning in June).
  3. Begin to evaluate hazards associated with each process step and/or ingredient and ways to either sufficiently reduce its probability or to control the hazard.

Dr. DeRouchey expressed that there were still details being worked out, but the main takeaway is for feed mills to be prepared for an increase in training and documentation required by the FDA.

As both producers and consumers, we understand the importance of food safety and regaining the consumers trust.  The Food Safety Modernization Act will prove as another bridge to show consumers how we care for our animals in every step of production and ultimately theirs and our food.

For more questions regarding FSMA, contact Dr. Cassie Jones at jonesc@ksu.edu or Joel DeRouchey jderouch@ksu.edu.