Seventy-two years: That's how long it had been since the FDA's food safety laws have been significantly overhauled.
Yet every year, 48 million Americans are affected by food-borne illnesses, resulting in more than 3,000 deaths annually. Congress and the president simply had to act. And their passage of the Food Safety Modernization Act (FSMA) is certainly a step in the right direction.
The new regulations signal major changes for the food manufacturing, packaging and distribution industries. Among them are expanded FDA powers, which will enable the administration to:
- Conduct more frequent inspections and set testing requirements of food facilities
- Standardize mandatory recalls and the closing of facilities
- Provide access to additional records and a more comprehensive collection of data
- Assist state and local governments in handling food emergencies
- Establish new regulations and ensure that imported foods meet the same standards
Following What's Already Working
Interestingly, much of the language in this new law is actually very similar to the standards already set by non-governmental organizations such as the Global Food Safety Initiative (GFSI) and those already included in Hazard Analysis & Critical Control Points (HACCP), both of which have been around for more than a decade.
GFSI is a collaboration between some of the world's leading food safety experts from retailers, manufacturers and food service companies, as well as service providers associated with the food supply chain. HACCP, on the other hand, is a management system in which food safety is addressed through the analysis and control of biological, chemical and physical hazards-from raw material production, procurement and handling to manufacturing, distribution and consumption of the finished product.
In early 2008, Wal-Mart became the first U.S. nationwide grocer to require suppliers of private-label and select food products to have factories certified according to one of the approved GFSI standards. Since then, a number of other retailers and food service organizations in the United States have begun requiring GFSI standards certification in order to be suppliers.
The FSMA mirrors much of the same language found in these standards. And that's a good thing; it means that the government is trying to catch up to methods and processes the industry has recognized and largely followed for more than a decade. Adopting what's been proven to work means that the FDA doesn't have to reinvent the wheel.
Who Will Be Affected?
For the food manufacturing facilities that are either certified to a GFSI-recognized standard or are in the process of certification, the FSMA will probably have minimal impact. Many of the requirements for certification-which include the development and documentation of a food safety plan, lot traceability and recall management-are anticipated to be compatible with new regulations.
Similarly, for companies that have adopted and implemented HACCP, the new requirements introduced by the FSMA will probably have minimal impact in regard to the prevention of food safety problems. Most large and midsize food facilities today most likely grew to their current size by distributing their products to one or more of the larger retailers already requiring GFSI standards certification.
However, for the food facilities that are neither participating in the GFSI standards certification nor are required to participate in HACCP, the new regulations and inspections could be a challenge. Small regional and local food facilities with annual revenues over $500,000-those businesses too large to fit within the FSMA amendment to exempt small, local food producers and processors-will invariably be challenged by the new record-keeping and track-and-trace requirements.
To comply, they will have to increase prices to cover the additional costs of compliance or risk fines for noncompliance. It will be just a matter of time before many have to choose between closing their doors or being acquired by larger organizations that have the expertise and resources to comply with the new regulations.
Where the Law Falls Short
Granted, these prevention and intervention measures have merit. Some, in fact, are badly needed. But missing from any of this legislation are measures to drastically improve the response to food safety outbreaks.
Rather than requiring food companies to upgrade manual tracking and tracing methods to electronic record-keeping applications, the new regulations call for a pilot project to explore and evaluate the methods for rapid and effective tracking and tracing.
Essentially, the law as a whole is requiring much more of food companies in terms of their ability to respond to outbreaks, yet it fails to require that these companies implement the type of record-keeping system necessary to respond effectively. Not only that, but it also forgoes any decision on the topic for up to three years after enactment.
Too Much at Stake
Forward-looking producers are not sitting on the sidelines. Recognizing that their entire business could be at risk if a contaminated lot was not rapidly identified and traced in the event of an outbreak, these companies have adopted enterprise software to automate and integrate traceability across the multiple steps in their supply chains.
Track and trace capabilities enable manufacturers to trace a finished product lot in both directions: forward to all distribution points and back to all raw ingredient lots and sources. This kind of technology helps businesses pinpoint every step in the manufacturing process at any time-all done in minutes. In the event of a safety alert, this capability can help prevent illness and death. Think about the huge impact of adopting these capabilities: reducing food-borne illness by just 1 percent would keep about 500,000 Americans from getting sick each year; reducing food-borne illness by 10 percent would keep about 5 million from getting sick.
Food manufacturers are also seeing increased demand for brand protection measures from their larger customers in retail and distribution. Many of these companies have instituted food safety audits and mock recalls that require rapid access to accurate summary product lot information with detailed supporting results.
The cost of a failed mock recall can be catastrophic for a food manufacturer. And, in the case of a safety recall, not having lot-specific information in a timely manner may force the manufacturer to expand the size of the recall. In effect, the manufacturer would potentially need to recall all existing lots in distribution centers, on store shelves and in consumers' cupboards, due to the inability to accurately identify the affected lots. This can result in economic disaster to the manufacturer.
Tracking and tracing technology is no longer a luxury. In an environment of tougher regulations, greater risks and increased consumer awareness, prevention measures must be supplemented with rapid-response capabilities.
Jack Payne is vice president, Enterprise Software at CDC Software. CDC Software offers hybrid enterprise software solutions that include (ERP), manufacturing operations management, enterprise manufacturing intelligence, supply chain management, global trade management, e-Commerce, human capital management, CRM, complaint management and aged care solutions, in on-premise or cloud deployments.
