Rules to Follow
By Patrice Charlebois
With regulations on food safety getting more stringent, no risk is too small for food producers
In the third quarter this year, the Canadian Food Inspection Agency (CFIA) issued 32 mandatory recall alerts for contaminated or mislabelled foodstuffs. In the third quarter of 2011, 39 health hazard alerts were issued; recalls were voluntary.
What spurred the change to more stringent regulations?
In 2011, the U.S. enacted the Food Safety Modernization Act (FSMA), a legislation that would have a major influence in framing Canada’s own Safe Food for Canadians Act (SCFA), which came into effect in January 2019.
Broadly speaking, the SCFA regulations (SCFR) align Canadian regulatory regime with FSMA, only with fuller coverage. For example, it covers poultry and meat, whereas in the U.S. they remain under the Department of Agriculture (DEA) jurisdiction.
Like FSMA, the Canadian reforms shifted the emphasis in risk mitigation from “should do” to “must do,” with increased emphasis on prevention. Inspection regimes and penalties were toughened, with the Canadian regulations also extended to non-food issues such as weights and consumer protection.
Canadian producers with FSMA or third-party food safety certification, or an effective HAACP program to eliminate potential hazards, are already largely SFCR-compliant.
Those manufacturing, processing or packaging meat, fish, dairy or egg products are required to have a Preventive Control Plan to identify and minimize risks in their operations.
The Current Good Manufacturing Practices (cGMPs) under FSMA CFR Title 21 117.40 detail the cleanability and cross-contamination standards plants must meet. They provide a good baseline on which to inform purchases of new equipment.
Yet, even with FSMA-compliant processors, there may be seemingly innocuous but preventable risks that can elude even a well-managed safety program, particularly in maintaining older equipment.
Most can be identified and corrected at relatively little cost through regular audits.
Typically, these issues involve the exposure of food contact surfaces to contaminants in compressed air—through inadequate filtration or leakage.
They can also be the result of leakage of non-food grease or other liquids, or be caused by the bacteria or dirt lodging in avoidable nooks and crannies.
Naturally, metal shavings and other fine metal particles or chemical residue in food will cause a recall just as surely as salmonella or e-coli bacteria.
A food contact surface, as defined by the FDA, is one that comes into contact with food or to which food drains “in the normal course of operations.”
The European regulation is more stringent:
“It is any area where food can come into contact with the surface, or drip, drain or diffuse or be drawn onto it, even incidentally.”
The CFR Title 21 117.40 requires all equipment and utensils to be designed and manufactured so as to be “adequately cleanable” and be maintained to protect against allergen cross-contact and contamination.
Some of the most pressing design and maintenance considerations, include:
• All components and utensils should be designed—or in the case of replacement parts, selected—to avoid contamination from lubricants, fuel, contaminated water, metal fragments, etc.
It is important not to overlook locations where contaminants can puddle or collect. Small design choices, like squared rather than preferred rounded corners, can become dirt/bacteria traps.
Food contact surfaces in proximity to food must be corrosion-resistant.
Products designed primarily for food zones must not only provide the necessary corrosion-resistance and cleanability, but also offer a longer service life and other benefits.
For example, Festo’s clean-design IP-69K valve manifold MPA-C doesn’t need a protective control cabinet. As a bonus, by locating the manifold close to the process, tubing lengths are shortened for more repeatable cycle times (and potentially higher production rates) or reduced compressed air consumption.
• If you use a lubricant on a machine, you must know know it’s food-safe. Most pneumatic actuators do not use food-safe grease, and will leak grease over time.
To address this issue, consider incorporating cylinders like Festo’s clean-design CRDSNU that uses FDA-approved NSF-H1 grease. If such grease comes in contact with the food zone, it’s acceptable.
In addition, the tubing itself should be resistant to cleaning agents and, if the process requires it, high temperatures or high pressure.
Festo offers a broad range of food- and beverage-appropriate tubing rated for regular cleaning, for intensive cleaning, or for use particularly demanding environments—namely the rugged new food-safe PTFEN tubing with high temperature and chemical resistance.
There are also food-safe sealing options for cylinders, like Festo’s A3 for very aggressive operations, enabling the cylinder to function even after all its grease washes off.
• Exposed thread on a fitting is a potential contaminant trap. In general, we highly recommend parallel threads such as a G thread for all fittings and tubing in the food area.
When threading a tapered thread, the debris that can come off can enter your process or pneumatic system. You can only detach and reattach such a fitting three or four times before thread wear results in too much damage, or leakage.
For food-safe operations, avoiding exposed thread is always a good idea.
For non-food zone equipment like secondary packaging and palletizers, the regulations require only that they must be capable of being kept clean and sanitary—not that they always be clean and sanitary.
That said, I expect to see growing demand for more easy-to-clean packaging equipment, especially the machinery located right after primary packaging—labelers, case-packers and more.
• As for the critically important issue of compressed air quality and leakage, neither the 21 CFR 117.40 nor SFCR impose a standard, although Many trade and certification bodies recommend filtering to a 0.01-micron level for the food zone.
For example, SQF Code Edition 7.2 Implementation Guidance (section 11.5.7, Air Quality) recommends final stage filtration of 0.1 with an efficiency of 99.999-percent.
It is a fact that effective and aggressive filtration will extend the service life of actuators and associated components.
In addition, recent advances in leak detection, like the Festo MSE6 energy efficiency modules, will detect leaks at an early stage.
Because compressed air also can be released through faulty tubing, or even something as innocuous as the venthole on a manually adjustable cylinder, Festo has eliminated the venthole (and associated risk) with self-adjusting cushioning (PPS) that adjusts optimally to changes in load and speed. It’s an option available with many types of Festo food-safe cylinders and actuators.
For a deeper dive into food safety regulations and componentry, Festo offers several white papers on food safety, cleaning in the food zone, and compressed air quality for food production—all available at www.festo.ca.
Patrice Charlebois is the industry segment manager for food and beverage at Festo, Inc., leading supplier of industrial automation.