FSMA and Hand Washing. Yes, Hand Washing

Embedded in the myriad rules and regulations of the Food Safety Modernization Act (FSMA) is a significant cultural shift in food manufacturing.

How so? The new law requires the food industry (and its many suppliers) to provide day-to-day management of all aspects of food safety, or suffer the consequences of government fines and public opprobrium. This represents a dramatic change from the largely voluntary approach of decades past amid a patchwork of vague, sometimes conflicting laws and regulations.

A perfect example of this transformation involves a simple procedure long associated with public health: hand washing. It’s long been standard practice (and a health code regulation) that employees working around or with food, whether in a restaurant, a growing field, or on a food manufacturing production line must wash their hands – thoroughly and regularly – while on the job.

handwashingPractically speaking, however, various studies over the years indicate that proper hand washing doesn’t occur as regularly or as thoroughly as needed or required. Even the ubiquitous hand sanitizer dispensers don’t offer the germ protection necessary to prevent contamination. Just as problematic is sketchy enforcement of hygiene. For food manufacturers and processors, hygienic requirements have always been nebulous. Many producers and processors have adopted the hand washing procedures outlined in the FDA Food Code or similar procedures. Yet the Food Code is only a set of recommendations and doesn’t carry the force of law.

With FSMA, these recommended procedures now become mandatory. Under FSMA’s required preventive controls,known by the acronym HARPC (Hazard Analysis and Risk-based Preventive Controls), manufacturers must create and maintain a thorough hygiene discipline throughout their facilities. Specifically, the new law says “management of covered facilities must ensure that all employees who manufacture, process, pack or hold food have the necessary education, training, and/or experience and ensure they receive training in the principles of food hygiene, food safety, and employee health and hygiene.” Such training includes thorough and regular briefings on proper hand washing protocols, as well as hand washing records available for FDA inspection.

Regulatory overkill? Perhaps. Hand washing seems like a such a small issue in the midst of a wholesale re-direction of food safety regulations under the Food Safety Modernization Act. Yet hand sanitation is a critical frontline technique to prevent the spread of harmful bacteria that can lead to outbreaks of Hepatitis and other illnesses. This has been the FDA’s intention for decades; now, with FSMA, proper hand washing carries the force of law.

That’s a clear cultural shift that will impact workers, managers, and manufacturers all along the food supply chain.


The Challenge of FSMA Transparency


The critical importance of food transparency was underscored by the results of a recent global survey on consumer attitudes about overall food safety. Bottom line, confidence in food safety has declined, and consumers look to manufacturers and retailers to be proactive in preventing food contaminations and recalls. Read about the survey results here:


The new Food Safety Modernization Act (FSMA) presents food manufacturers and their suppliers with a significant challenge: how to efficiently filter FSMA preventative controls down the food supply chain to encompass the thousands of suppliers and vendors that will have to create and manage their own food safety plans?

The answer lies in a key section of FSMA, which codifies in its regulations the concept of “supply chain transparency.” Under the new regulations drawn up by the Food and Drug Administration (FDA), a manufacturing/processing facility must have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control. In other words, at every step along the food chain from farm to table, manufacturers and producers must be fully cognizant of the safety controls of their suppliers – and have the records to prove it.

Actually, transparency has been around for several years in business-to-business circles. A series of disastrous food recalls traced to suppliers who either didn’t know what they were doing, or intentionally sold adulterated, unsafe product, prompted businesses here and abroad to begin putting their suppliers on notice: unsafe practices will not be tolerated. Under FSMA, manufacturers are obliged to hold their suppliers to the same food safety standards they must follow.

(Transparency and another descriptor, traceability, are often used interchangeably, but have slightly different meanings. Traceability usually describes the technical ability to verify the identity, history, location or application of an item, while transparency is used when talking about broader collaborations among trading partners in the food chain).

For the FDA, supply chain transparency is part of the agency’s new operating model that emphasizes strengthened collaboration and improved information sharing and gathering among trading partners, data-driven risk analytics, and the smart allocation of resources for food safety management.

food mfg close upThere are many places along the manufacturing production line where unintentional food adulteration may accidentally occur. Water used to hose down equipment may contain harmful bacteria. The lubricants used to keep the machines running at peak efficiency might touch the product as it whizzes by. And so on.

Suppliers of material used in manufacturing, such as lubricants, are required under FSMA to demonstrate that their products are properly formulated, labeled, stored and used to prevent compromising food safety, and that only “food grade” lubricants are allowed in those parts of the manufacturing facility where the food is produced. Lubricant manufacturers also must document their processes so that if a food safety problem arises, preventative control records and product formulations are readily accessible should a problem arise.

Over time, transparency will become second nature for manufacturers and their many supply chain partners. For the time being, however, companies all along the food chain are quickly realizing that the new way of doing business to prevent food contaminations will require time, attention and management focus not just inside their own operations, but also up and down the supply chain.