On May 26th, 2011, The U.S. Food and Drug Administration (FDA) issued a release seeking public comment on preventive control measures for food facilities through a public docket opened as part of the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January.
The FSMA requires registered food and feed facilities to evaluate the food safety hazards that could affect food and feed they manufacture, process, pack, or hold and to identify and implement preventive controls to address those hazards. The agency opened the docket to solicit specific recommendations from stakeholders on what preventive control measures are appropriate, and any other pertinent information and recommendations, including measures that are workable for small businesses.
The FDA is required to issue guidance with respect to hazard analysis and preventive controls, and information submitted to the docket will be considered in the development of that guidance.
As a stakeholder serving food and feed facilities, Nilfisk Industrial Vacuums found it appropriate and necessary to submit our public comments regarding preventative control measures, as they apply to proper housekeeping. The following is our official public comment.
August, 2011
Re: Public Comment for Preventive Controls for Registered Human Food and Animal Food/Feed Facilities: Docket No. FDA-2011-N-0238
We appreciate the opportunity to submit our comments regarding the FDA’s Food Safety Modernization Act, as it relates to Preventative Controls for Registered Human Food and Animal Food/Feed Facilities. As a leading provider of HEPA filter industrial vacuum cleaners for more than 50 years, Nilfisk Industrial Vacuums is highly aware of the challenges and concerns today’s food manufacturers face as they attempt to produce a high-quality product, free from contamination, while simultaneously meeting government and industry guidelines. Our Product Manager and Application Engineer regularly field questions from customers looking to us for advice on how to efficiently and cost-effectively keep their plants clean through the use of industrial vacuum cleaners. While we enjoy these calls and do our best to advise our customers, Nilfisk Industrial Vacuums is not a regulatory authority; we can only provide information as it pertains to our products, and therefore see the need for well-defined preventative control guidelines that address housekeeping best practices within food manufacturing facilities. We hope you’ll take our below recommendations into consideration.
COMMENTS:
The below general comments are in regards to these points, as specified in section II of Docket No. FDA-2011-N-0238
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Implementing process controls
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Implementing sanitation controls
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Allergen control (human food) including…procedures and practices to prevent the unintentional incorporation of a major food allergen into a food by cross contact during manufacturing, processing and holding food.
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Preventative control approaches and practices that are practical for small and very small businesses to implement
From transferring and preparing ingredients, to mixing, baking, and packaging, food manufacturing facilities often generate large amounts of dust throughout the manufacturing process. If not collected at the source by a vacuum cleaner integrated into the processing system, the dust quickly settles on floors, machinery, hard-to-reach, and overhead areas. This dust is a breeding ground for insects, rodents and many different types of bacteria. For this reason, it is critical that food manufacturers implement a comprehensive maintenance plan that keeps dust levels at a minimum. Currently, food facilities use many different tools for keeping dust at bay, and while some may work well, there are definite advantages offered by certified HEPA filtered industrial vacuum cleaners that the other methods lack. For this reason, we encourage the FDA to better define best housekeeping practices, and to consider the following:
• While mops, brooms, and compressed air all have their place in maintenance plans, these methods often leave particles of dust and debris behind. Actually, compressed air only moves dust from one place to another; it does nothing to eliminate the dust. Also, mops and brooms promote growth of bacteria and can easily spread bacteria and pathogens to many areas of a facility. Industrial vacuum cleaners equipped with multi-stage filtration, including a certified HEPA filter, trap and retain collected materials, without distributing it back into the atmosphere.
• In addition to general maintenance, specialized industrial vacuum cleaners can be utilized for source capture to collect dust at the point of generation before it can accumulate in various areas of the plant. This can also improve allergen control, by containing dust (ie. peanut dust) at the source before it can spread to other processes.
• Housekeeping should be as easy and ergonomic as possible (lightweight and user-friendly)
• Industrial vacuum cleaners can be equipped with food grade hose and accessories customized for the food industry, such as those for overhead cleaning and hot oven cleaning.
• Currently there is no homogenous color coding system for the food industry. Manufacturers create their own coding system (eg. blue wall brushes for cleaning allergen production lines). We recommend the creation and implementation of a standard color coding system in the food industry in order to decrease cross contact of allergens and bacteria.
• Not all industrial vacuums are equal.
• The food industry should use industrial vacuums equipped with High Efficiency Particulate Air Filters (HEPA) that at a minimum remove 99.97% of particles, down to and including 0.3 microns. These filters should be tested and approved by a private testing body.
• High quality HEPA filter industrial vacuum cleaners are often available in stainless steel. Stainless steel vacuums won’t chip like painted vacuums (another possible source of contamination) and are easy to clean.
• Currently, many manufacturers use “shop-style” vacuums in some capacity. While these may be adequate to collect dust, they are often known for their short lifespan, which often cost manufacturers more in the long run through replacement costs. (See supporting document for ROI analysis)
• Also, shop-style vacuums should NOT be used to collect hazardous dust, such as flour and grain (reference OSHA’s Combustible Dust NEP). Using these vacuums to collect combustible dust can cause a fire/explosion due to their plastic construction, exposed motors and tendency to overheat.
SUPPORTING MATERIALS
Please view the attached supporting materials:
- Published Article: Survey Says: Clean for Safety and Profitability
- Published Article:Left in the Dust: Industrial Vacuum Cleaners Outperform Mops, Brooms, Shop-style Vacuums
- Case Study: McDonald’s Bun Facility Finds Vacuum Worthy of High-Tech Operation
-Video Case Study: Harris Woolf Almonds Receive AIB Recognition with the use of an Industrial Vacuum Cleaner
Sincerely,
Paul R. Miller
Vice President & General Manager
Nilfisk-Advance America, Inc.
A combination of efficient design and powerful suction, our Nilfisk VT60CR is a cleanroom vacuum that simultaneously picks up wet and dry debris without special adapters or filter switching. It is ideal for cleanroom applications across various industries such as semiconductor, food, pharmaceutical, and biotechnology. 
