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From: The eUpdate, 4.23.13

FSMA and the Peanut Butter Industry

Ensuring food quality in light of prior Salmonella illnesses linked to peanut butter

by Kelly Kuchinski

Over the last several years, the food and beverage industry has been plagued with recalls and food borne illnesses, affecting revenues and brand reputation. More so, the concern to consumer safety made the passing of the Food Safety Modernization Act (FSMA) more than necessary.

Prior to the FSMA, companies produced and distributed product throughout the global supply chain—from supplier, to manufacturer, to wholesaler, to distributor, and finally to retailer. In the event of an adverse event, companies were required to notify the FDA, retailers, and consumers and withdraw all products from supply chain.

Unfortunately, in some cases, manufacturers knowingly distributed contaminated products that were used by other manufacturers in their product production.

One of the largest recalls in the U.S. involved a supplier’s peanut products that were contaminated and distributed to more than 200 companies. This resulted in the recall of more than 3,900 products containing peanuts, tarnishing the images of many popular brands. The industry lost an estimated $1 billion and eventually forced the supplier to shut down operations.

Up until recently, there were no regulations in place that enforced suppliers to track products, and inevitably protect peanuts from getting contaminated. This meant that peanut butter companies had no visibility into how the peanuts were produced, processed, and distributed.

The introduction of FSMA brought greater insight into how peanut butter was being produced to ensure product safety. Some of the improvements made by the FDA to make peanut butter safer included:
• Mandatory recalls and inspections;
• Evaluating data every two years to determine what contaminates food, taking a risk-based approach to focus on threats rather than current processes;
• Stricter regulations requiring importers to verify foreign suppliers are meeting U.S. standards; and
• Enforcing almost every food company to implement a quality assurance system to create a preventative-control program.

These reforms entitle the FDA to make more onsite visits and have a say in recalls. If a peanut butter or any food and beverage manufacturer isn’t meeting safety requirements, the FDA can shut down operations and take over the facility.

By requiring data to be evaluated every other year, the FDA can determine which raw materials pose a greater risk to the food and beverage industry. Products containing peanuts have a higher risk of contamination, holding peanut butter companies responsible for any contaminated raw materials from suppliers.

Recently, federal prosecutors filed criminal charges against the former owner and several employees from the Peanut Corporation of America, the source of a 2009 Salmonella outbreak that killed nine people and sickened more than 700. The indictment charged those involved with misleading customers when tests revealed the presence of Salmonella in its peanut products. The charges also described an arrangement made to devise certificates of analysis that stated the shipments were safe, when they were actually contaminated or had never been tested at all.

Quality Management
Although it is easier to source raw materials from local vendors, in today’s marketplace it is more common that raw materials are sourced from all over the globe. Ensuring the quality of the supplier is instrumental in developing a safe and compliant product. Manufacturers can verify that the supplier meets set requirements through diligent auditing and testing. This can be done through company or third-party auditors. Reviewing farms or production facilities can verify the thoroughness of their quality control and quality assurance processes.

The issue may not solely lie with suppliers, it could also stem from inside a facility or the third-party manufacturers or packagers. Companies have a responsibility to safeguard the quality and safety of the products that they manufacture and sell.

Internally, companies need to perform raw material and finished product testing in-house or at a qualified outside facility. Each product batch needs to pass analytical, physical and microbial testing to ensure the product is in specification and free from contamination or adulteration. By enforcing supplier risk-based audits, manufacturers can be more proactive in safety measures by auditing the facility to make sure equipment is up to par and being properly sanitized and ensure production is safe and meeting regulatory requirements before the product is distributed.

Monitoring contract manufacturers and packagers for these same regulatory requirements also ensures the product that bears the name of the brand owner meets the quality standards of the brand. A proactive approach to risk-based audits at the facilities and to those products that have a higher risk of contamination can provide insight early on to the quality of their suppliers and proactively protect the brand reputation from high profile product recalls.

An integrated quality management framework can automate quality and workflow process into an enterprise pillar system that meets regulatory and corporate requirements for management of investigations, root cause analysis, Corrective and Preventative Actions (CAPA), and change control.

This allows these keys changes to be effectively processed and documented throughout the entire enterprise to ensure compliance and reduce ongoing errors in production, testing, packaging, and others key areas of the plant.

By implementing an enterprise quality management software solution, food manufacturers can create the preventative-control program set forth by the FSMA to:
• Centralize information that manages enterprise auditing to reduce costs and create efficiencies by sharing information between multiple audit groups;
• Provide transparency by tracking and managing resources inside and outside the facility for better business decisions; and
• Create greater efficiencies with critical issues and KPIs throughout the enterprise to help streamline current processes.

Under the FSMA, FDA has the power to enforce recalls and suspend factory operations without a court hearing. As a result, the FDA investigated and closed down the Sunland New Mexico plant, which was linked to the recent Salmonella outbreak in the U.S. Implementing a quality management framework can help all food and beverage companies avoid this outcome and ensure product quality and safety, protecting their brand and market share.

Kuchinski is the industry solution director at Sparta Systems. She can be reached at



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