Offering solutions for FSMA compliance

by Dr. Gerardo Morantes
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The Bühler pelleting system HYPAC unites state-of-the-art hygienizing  and compacting technology with the most rigorous safety standards.
Photos courtesy of Bühler.
The U.S. feed industry manufactures around 190 million tonnes per year, in approximately 6,000 feed mills, with broiler feed production leading the way, followed by swine, layers, dairy and beef. In this context, the Food Safety Modernization Act (FSMA) regulations (first part), including the animal food rule, went into effect in September 2016.

The law enacted in 2011 has been called the most sweeping reform of U.S. food safety laws in more than 70 years.

It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it, which intends to better protect public health (human and animal), by adopting a modern, preventive, and risk-based approach to food safety regulation (Title 21 of the Code of Federal Regulations, part 507-Animal Food).

The seven pillars of the law aim to have a distinct role to comprehensively regulate and modernize all aspects of the food industry, including the “animal food industry.”

The animal food rule establishes new Current Good Manufacturing Practices (CGMPs), Hazard Analysis and Risk-Based Preventive Controls (HARPC), specifically for the manufacturing, processing, packing and holding of animal food. It includes new preventive control provisions, and applies to domestic and imported animal food, including pet food, animal food, and raw materials and ingredients.

Feed mills with more than 500 full-time employees will need to be in compliance with the Preventive Controls by Sept. 18, 2017. Those same facilities should already be in compliance with the Current Good Manufacturing Practice since Sept. 19, 2016.

Requirements are established for a written food safety plan, a hazard analysis, preventative controls for known or reasonably foreseeable biological, chemical, and physical hazards. It includes process and supply-chain controls, as well as a recall plan.

This area represents the biggest opportunity for customers in this segment. Training takes relevance as a priority to fully understand the breadth and the scope of the regulation requirements. Both the Food Safety Preventive Controls Alliance (FSPCA) and private companies and industry associations are offering training programs to help on the practical side of a facility’s implementation program.

The expectation to reanalyze the Food Safety Plan at least every three years, and/or when a significant change that creates a new hazard, or it becomes obsolete after an unanticipated food safety problem, is part of the 21 CFR 507.50 (a) federal codes of regulations.

Corresponding validation, monitoring, corrective actions, verification and associated records are also required. Bühler offers Smart Validation Services to help customers that need to have a validation of their biological hazards control step in their process.

Many of these activities must be conducted (or overseen) by a preventive controls qualified individual. A preventive controls qualified individual is a qualified individual who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. Records documenting the required training in the principles of animal food hygiene and animal food safety must be established and maintained.

If a manufacturing facility has identified in its raw materials and ingredients a hazard that requires a preventive control, the facility needs to address the how, who and when the control activities happen. Not only that, but those actions need to be properly documented (records) to prove that they happened. Access to records is one of the prescribed actions granted to enforcement agencies. It includes electronic records, which need to be available in the case of a facility inspection.

Bühler’s automation solutions offer a food safety specific solution (WinCoS) to ensure proper process record integrity and traceability capabilities reporting.

In summary, the new regulation creates new CGMPs requirements for animal food facilities. In addition, the regulation creates new requirements for certain animal food producing facilities to establish and implement risk-based preventive controls.

The first stage (year 1) of FSMA compliance involves CGMPs. They are nothing more than the baseline standard in terms of plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations management and raw materials, as well as holding and distribution conditions.

In addition, animal food producing facilities subject to the supply-chain program requirements of this rule are responsible for ensuring that ingredients are only sourced from approved suppliers and it has to be verified through audits, testing of raw materials and review of supplier’s food safety records.

The range of supply chain solutions, offered by the Bühler Sortex platform, to help manage the chemical and physical hazards risk in the grains supply chain have already established a proven track record of performance in many different food-related industries.

In this platform, optical sorting is used to detect and separate grains damaged by mold growth therefore containing high levels of mycotoxins.

Compliance with the supply-chain program is tied to the implementation of the PCAF rule (six months delay).

Bühler has been on the food safety journey for a long time, given its global scope, keeping abreast of the trends all over the world. Translating those trends into new product development and services has been essential to convey practical solutions to customers, which can address the requirements of the FSMA and other countries’ regulations.

These efforts are coupled with extensive, continuous employee training, as well as establishing partnerships with industrial and scientific institutions to offer state-of-the-art food safety solutions.