LE MARS, IOWA — The roll-out and implementation of the Food Safety Modernization Act has brought change to all aspects of food and beverage manufacturing. Food Business News recently spoke with the food safety team at Wells Enterprises Inc., Le Mars, to learn how the company prepared for the recently implemented F.S.M.A. regulations, which were signed into law by President Obama on Jan. 4, 2011. The regulations aim to shift industry focus from responding to contamination to preventing it. This mandatory legislation went into effect July 14.

As with all commercially produced and distributed food, ice cream manufacturers must make food safety the No. 1 priority. Many processors go above and beyond what is deemed mandatory by federal regulations. This includes Wells, the largest privately held, family-owned ice cream and frozen treat manufacturer in the United States. Wells produces more than 150 million gallons of ice cream a year, including its signature brand, Blue Bunny and the iconic Bomb Pop. Wells also manufactures licensed frozen treat brands including Weight Watchers frozen novelties.

Food Business News spoke with Brad Swart, senior director-quality assurance, food safety and environmental health and safety, and Brian Kraus, senior manager-food safety and regulatory compliance, at Wells Enterprises about how the new regulations have affected the company’s operations.

Food Business News: Food safety starts with employee education. What type of training do employees complete before working on the production floor? Is there an on-going safety education program?

Mr. Swart: Our new employee orientation program includes food safety and Good Manufacturing Practices (G.M.P.) training. Annually, employees complete refreshers on a variety of topics, including allergens, food safety and G.M.P.s.

Mr. Kraus: Regulatory training is required for employees that manage a food safety plan (F.S.P.). These employees are identified as Preventative Controls Qualified Individuals (P.C.Q.I.). We are only required to have one person per plant to be trained, but at Wells, 45 people have completed the training.

Wells Enterprises
Before touring Wells' facility, guests must watch a safety video.

Even guests must watch a safety video before touring the manufacturing facility. When did this get implemented and why?

Mr. Swart: Wells implemented the safety video in 2008. We take this very seriously because we want visitors to adhere to the same G.M.P. requirements as our employees. This is important for the safety of the visitor, our employees and for food safety reasons.

Wells received level three certification from the Safe Quality Food Institute (S.Q.F. III) in 2008. How did this impact your business back then and how has it prepared you for F.S.M.A.?

Mr. Kraus: Becoming certified enhanced our verification and validations process, and our food safety documentation. The certification really helped to lay the ground work for F.S.M.A., putting rigorous protocols into place that are now required.

How has F.S.M.A. impacted day-to-day operations and how did Wells prepare and implement the rules?

Mr. Kraus: Wells has updated its F.S.P., which followed the principles of Hazard Analysis and Critical Control Point (HACCP). This plan establishes science-based preventive control measures to reduce the risk of food contamination, which some refer to as Hazard Analysis and Risk-Based Preventive Controls (HARPC). Under the new F.S.P., Wells has identified and implemented science or risk-based preventive controls, replacing the critical control points (C.C.P.s) as required by the conventional HACCP system. The validity of these preventive controls for minimizing the significant food risks is supported by scientific data or authentic scientific literature. Additionally, allergen control is a growing concern within the food manufacturing industry and one that F.D.A. specifically mandates within the new rule. Wells has allergen control verifications steps in place and has validated the allergen control program. Furthermore, Wells has more than required P.C.Q.I. to oversee the F.S.P.

Wells Enterprises
Prior to starting a production line, a final pre-operational inspection is conducted by Wells' quality team.

What are some voluntary food safety/sanitation upgrades Wells has implemented in recent years and why?

Mr. Swart: Wells is committed to providing safe ice cream products for consumers to enjoy, and regards food safety with the utmost seriousness. Wells has a strong organizational commitment to a robust environmental monitoring program, which includes a very thorough root cause analysis process aided by advanced microbiological analytical methodologies.

A few of the items we implemented over the years to enhance our food safety program include a thorough review of our pathogen environmental monitoring program, adding product contact testing to further verify the food safety of our product processing environment. We also now include allergen verification and validation procedures for all cleaning practices. Finally, prior to starting a production line, a final pre-operational inspection is conducted by our quality team.

Mr. Kraus: Pending a successful pre-op inspection, the line can then be released to operations to commence production. Our checklist includes pre-operative inspections. For example, this includes visual inspections aided by Adenosine Triphosphate (A.T.P.) swabs to measure the presence of organic matter on the line. We also review all the pre-operation, product micro-analysis and environmental data to determine sanitation efficacy daily and weekly.

Condensation is a potential carrier of undesirable microorganisms, in particular the omnipresent Listeria. What steps does Wells take to prevent condensation from forming, and if it forms, from making contact with food?

Mr. Kraus: To combat condensation, we have done the following: increased employee awareness, made line modifications, developed condensation trays, implemented additional environmental temperature controls, made heating, ventilation and air conditioning upgrades to condition the air within the plant, and made piping modifications.

Wells Enterprises
Wells produces more than 150 million gallons of ice cream a year, including its signature brand, Blue Bunny and the iconic Bomb Pop.

Air, too, also carries microorganisms. What voluntary steps does Wells take to ensure only the cleanest air is circulated throughout the plant?

Mr. Kraus: The air defined as “point-of-contact air” is filtered through .01 micron, which is considered sterile.

To assist employees with identifying team members, as well as new employees who might need extra guidance with implementing food safety procedures, Wells uses a color coordinated uniform and hard hat system. Please describe this program and how it assists with operations.

Mr. Swart: Different areas of the production facility have different colored hard hats designated for that respective area. This prevents cross-contact and cross-contamination between production areas.  New employees wear a yellow hard hat during their probationary period, ranging from 4 to 12 weeks. The program is designed to keep both the product and employees safe by easily identifying the new employees.