FE 2011 4 Supplements

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Badman, Lorna

From: [email protected]: Monday, November 28, 2011 9:16 AMTo: Robert Almblad

Subject: 2nd Open letter: ClarificationAttachments: Cocoa ice.pptx

After some discussions of my first open letter, there are a couple points I need to clarify.

All the ice machine brands that I tested have excluded a dustproof barrier and therefore either push orpull air through the food zone. We use cocoa powder to test because that is also what the US military

uses. The attached photo are test results of another ice machine that "pushes" air through the food zone.

The photo shows ice dispensed into clear cups and allowed to melt before taking the photo.

The absence of the dustproof barrier makes the ice machines in violation of the FDA Food Code as adoptedby all 50 States and enacted into law by most, if not all States. (for example, in the case of Florida, the

FDA Food Code was adopted in 1999 and passed into law in 2005). Once the Code is enacted into law ,the fact that an ice machine has an NSF approval does not have any bearing or authority over State law.

The State is obligated to enforce these codes and punish offenders with fines and imprisonment, see FDA

guidelines at bottom of this letter. They are severe.

This is a serious problem for ice machine manufacturers and NSF is not a solution. There is a machinedesign error that needs to be corrected and corrected quickly to reduce liability.

When I first presented my HEPA technology to the ice machine industry, your customers compared it to

other cleaning systems like UV. But, now that it can be used to create a dustproof air barrier, I don't think

it will be compared to other cleaning systems. This is a system that gets them into Code compliance and ifit additionally keeps the ice machine cleaner, that is a plus point, but not the reason they will do this.

This is a giant liability to all the ice machine companies and their customers, particularly in high risk

locations like hospitals where there is stricter enforcement of Codes.

The absence of a dustproof barrier is a State Health Code violation and really has nothing to do with HEPA

filtered air. It is a problem by itself and every OEM will have to deal with it one way or another. I am justsuggesting a way of handling the situation with HEPA filtered air and the "Black Box" I designed. Black Box

= I have designed and tested the best ways of creating dustproof barriers and filed patent applications onthese methods. But, as I said, when the dust settles, I don't think anyone will want ice machines with just

a dustproof barrier and no HEPA system. HEPA filtered air is just a better way of storing and dispensing

ice.

I am willing to license everyone on a reasonable basis and we can quickly handle this problem by using all

my research and experience in this area. The HEPA system is easy and inexpensive to implement and the

costs can be passed on to your customer. In turn, your customer will have to pay for monthly filterchanges, which is an additional cost, but still less than the cost of weekly cleanings, as recommended by

some healthcare institutions (and they think ice machines just store ice in non-moving ambient air).


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Copy Paste from FDA Food Code:

"Examples of how some jurisdictions have set fines, sentences, and penalties:

California law provides:

A. For Wholesale Food Violations:Criminal fines and sentence for violations of up to $1,000 and up to one year imprisonment if there is shown anintent to defraud or mislead, and Civil penalties of up to $1,000 per day for certain violations.

B. For Retail Food Violations:Criminal fines and sentence for violations of not less than twenty-five dollars ($25) or more than one thousanddollars ($1000) for each offense, or by imprisonment in the county jail for a term not exceeding six months, orby both such fine and imprisonment.

Maryland law provides:Criminal fines and sentence for certain misdemeanors of up to $10,000 and one year imprisonment, and in thecase of repeat code violation convictions, up to $25,000 and three years imprisonment; andCivil penalties of up to $5,000 for each violation and for each day the violation continues.

Texas law provides:Criminal fines and sentence for certain violations of up to $10,000 and two years imprisonment; andAssessment of five "severity" levels of administrative or civil penalties with base amounts ranging from $1,250through $10,000. Base amounts can be decreased or increased by as much as 50% considering factors such aspast performance, good faith, direct impact on health and safety, high-risk populations involved, etc.

Though rarely used with retail food establishments, Federal law provides under the Criminal Fine EnforcementAct of 1984 for a fine up to $100,000 for a misdemeanor by a corporation or individual not resulting in deathand,for misdemeanors resulting in death, a fine of up to $250,000 for individuals and $500,000 for corporations."


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Badman, Lorna

From: [email protected]: Wednesday, September 28, 2011 10:11 PMTo: Badman, Lorna

Cc: Susan Clickner; Davison, PatrickSubject: State level enforcementAttachments: Restaurant Inspections FDA Food Code.docx

Hi Lorna,

Sorry to trouble you again, but can you please add this short note and the attachment to my last

communication to the JC Chairman:

I just did a quick internet search and you can see that enforcement of the FDA Food Code for ice machines

separating the condenser unit from the food zone is taking place in some places at the state level. Pleasesee attached.

Thanks,

Robert


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Restaurant Inspections: PocahontasPancake- Waffle Shoppe - Virginia Beach

Go to:


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Bella Pizza, #101 - 4640 Shore Drive, Virginia

Beach, VA - Restaurant inspection findingsand violations

Restaurant: Bella PizzaAddress: #101 - 4640 Shore Drive, Virginia Beach, VirginiaPhone: (757) 363-8999

Total inspections: 11

Last inspection: Oct 7, 2009

1280 - The Ice machine does not have a dustproof barrier between the condenser unit and food or

food contact surface.

November 6, 2007

1280 - The Ice machine does not have a dustproof barrier between the condenser unit and foodor food contact surface.

Install a dustproof barrier between the condenser unit and food contact areas to prevent dust

contamination of food.

Read more: http://www.city-data.com/va-restaurants/Bella-Pizza8.html#ixzz1ZIi0pfRb

McDonald's, 13707 Jefferson Davis Hwy,

Woodbridge, VA - Restaurant inspection

findings and violations

Read more: http://www.city-data.com/va-restaurants/McDonald-s58.html#ixzz1ZIiJZJNm


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1280 - The @Ice maker@ does not have a dustproof barrier between the condenser unit and food

or food contact surface.

March 9, 2004

1280 - The @Ice maker@ does not have a dustproof barrier between the condenser unit andfood or food contact surface.

Install a dustproof barrier between the condenser unit and food contact areas to prevent dust

contamination of food.

Read more: http://www.city-data.com/va-restaurants/McDonald-s58.html#ixzz1ZIitrWrl

Restaurant Inspections: Gino's Pizzeria 01-

1745 - Virginia Beach

1479 General Booth Boulevard ##101/102

Virginia Beach, VA 23454

Inspection Date:August 17, 2005

Inspection Type:Routine

Critical Violations: 5

Noncritical Violations: 18

Violation Code: 1280


14/22

Badman, Lorna

From: [email protected]: Wednesday, September 28, 2011 7:22 PMTo: Badman, Lorna

Cc: Susan Clickner; Davison, PatrickSubject: Retrofit HEPA Filter SystemAttachments: Safe Ice Wall Mount.pptx

Hello Lorna,

Here is one more addition to the background of my issues document.

JC Chairman:

I think it is possible to get all he current ice machines manufactured in the US compliant with the FDAFood Code "dustproof barrier" and NSF 5.1.2 in maybe 9 to 12 months. This could be done by having

Ecolab retrofit a HEPA filter system when a new ice machine is delivered to the customer.

Please see attached drawing.

The ice machine companies would only need to punch a hole into the food zone and provide an electrical

plug to Ecolab's specification. That is the only change they would have to make. And, they can easilymake those changes and additions in 9 to 12 months from now, assuming we can all agree to this or

similar solution soon.....

About 2,000 ice machines are sold each week to different locations in the US that have the "dustproofbarrier" problem. Ecolab has about 3,000 wrench welding technicians that are already servicing most of

those locations, so they have the manpower capacity to perform this retrofit in the field.

When the new machine arrives at a location (any brand), an Ecolab tech can install the ice machine and/or

just commission the HEPA filter system. Ice machine is usually a simple operation because most icemachines of this type are replacement machines for one that is broken and takes about 1 hour or less. To

commission the HEPA filter system, it takes about an additional 15 minutes.

(This installation is practicing the Standard 12, Protocol 398 we have been working with Patrick Davison atNSF. I copied him on this email, so he may want earlier emails on this subject.)

The HEPA filter system's electrical connection would enable the ice machine to operate. Without thisconnection, the ice machine would not operate. This would be by design. This way the NSF certification

can be used on the ice machine when it leaves the factory floor because only with the secondary Ecolabfield activation of the HEPA filter system, does the ice machine actually have a dustproof barrier and

therefore earn the NSF seal of approval.

Anyway, I have had more time to think about this anybody, simply because I was the first to discover ice

machines were pushing or pulling large amounts of unfiltered air through the food zone. And, of course,


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UNIVERSALHEPAFILTERSYSTEMCANBEFITTEDTOANYICEMACHINEINTHEFIELDHEPA terandblower

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Badman, Lorna

From: [email protected]: Tuesday, September 27, 2011 3:52 PMTo: Badman, Lorna

Cc: Susan ClicknerSubject: RE: Standard 12

Hello Lorna,

Thanks, I appreciate the help.

Could you pass the note below , along with my earlier note to the JC Chairman? This is additional

background information regarding the Issue Document I sent regarding separation of the condenser unitfrom the food zone. Or, if I should re-submit the background information on the NSF published form, just

let me know and I will do that instead.

At Origin Tech we have developed and are testing a universal retro kit for adding HEPA filtered air to anybrand of ice machine in the field. For instance, we showed a prototype to Subway's equipment manager

and he said, and I paraphrase, "We don't normally mandate what equipment our franchisees buy, but with

Safe Ice's HEPA system we just might mandate it."

I am now discussing with Ecolab how to put together a program to convert existing ice machines at foodservice locations, like at Subway, with HEPA filtered air, regardless of the age or the brand of ice machine.

The retro-kit effectively creates a dustproof barrier between the condenser unit and the food zone bycreating positive air pressure, which acts as a dustproof barrier.

The basic retro-fit program for Ecolab is to clean the machine, install the retro-kit and then confirm it'seffectiveness with a certified particle counter, (the same particle counter that is used to classify

cleanrooms). Then, on a regular basis, Ecolab would return to change water and air filters and take culturesamples to verify sanitary conditions are maintained inside the ice machine and lastly, to annually re-

classify the cleanroom status with the particle counter.

What just came to mind is that maybe NSF can use the Ecolab retrofit program to keep all the ice machinemanufacturers moving forward with NSF approved machines, with their current design, even though they

push or pull air through the food zone. The idea is that maybe NSF could certify section 5.1.2 with the

caveat that the ice machine needs to be retrofited with Ecolab's Safe Ice within a certain period of timeafter it is installed in the field. This would be a lot easier than trying to get all the manufacturers to

change their design and not push or pull air through the food zone.

Allowing the machines to be retrofitted after or when they are installed in the field would be the leastdisruptive way to handle this situation of manufacturers passing NSF STD 12, section 5.1.2 regarding a

design for sanitary dispensing of ice. As I mentioned in my earlier note, it would be an economic hardship

for the manufacturers to try to seal 100 holes on machines that are already being mass manufactured.

As you know, Ecolab is already serving 95% of the food service customers like Subway, and so they would


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Then, some day when the manufacturers stop pushing or pulling air through the food zone and can pass

NSF STD 12, section 5.1.2, then they can remove the NSF caveat.

I hope this helps.

Thanks,

Robert AlmbladCEOOrigin Tech

727 742 9064

-------- Original Message --------Subject: RE: Standard 12From: "Badman, Lorna"

Date: Tue, September 27, 2011 11:11 amTo: "[email protected]"

Mr.Almbad,YourissuepaperhasbeensubmittedtotheJCchair. OnceIhearbackfromIwillprocessyourpaperaccordingly.

Lorna Badman, MS | Standards Manager | NSF International | Phone: 734.827.6806 | Fax: 734.827.6108 | E-mail:[email protected]

Pleaseconsidertheenvironmentbeforeprintingthisemail

From:[email protected] [mailto:[email protected]]Sent: Monday, September 19, 2011 9:32 AM

To: Badman, Lorna; StandardsSubject: Standard 12

Hello Lorna,

I have another request for a change in Standard 12, so I am sending it to you directly as well as

to the general mailbox because the form requests that I send it to the general mailbox.

Please see attached.


19/22

Badman, Lorna

From: [email protected]: Sunday, September 25, 2011 2:21 PMTo: Badman, Lorna

Cc: Davison, Patrick; John; Susan ClicknerSubject: Background and patent position

Hello Lorna,

I wanted to give you some background information on dustproof barriers in ice machines and someindication of what we are willing to do from a patent point of view.

As you may know, we have been working with Patrick Davison to develop a HEPA filter protocol underSTD-12 for Automatic ice machines.

When we discovered, 3 months ago, that sometimes the condenser fan on ice machines wasoverwhelming our HEPA filter system, we asked the ice machine manufacturers why they were pushing orpulling air through the food zone. And, everyone said they were unaware their ice machines in fact didthis. After demonstrating this to all the ice machine companies at the ASHE (American Society ofHealthcare Engineers) trade show, which was attended or exhibited by all the ice machine companies, noone was arguing or denying that they are not pushing or pulling air through the food zone.

So, after it was abundantly clear to everybody that we had discovered why ice machines were gettingdirty so fast, I submitted a request to add the FDA Food Code 4-204.18 "dustproof barrier" section to theNSF STD 12. And, it is not just because the FDA Food Code says to do this that we should do it. When wedemonstrated air blowing through the food zone to hundreds of attendees at 2 medical trade show, almosteveryone said something like: "don't they regulate against this?"

From a practical standpoint, it is going to be very difficult for the manufacturers to comply with 4-204.18because sealing a complex piece of machinery that is currently being mass manufactured is a daunting

task at best. Realistically, these machines would have to be redesigned from the bottom up with theintention to seal the two zones from each other. I have done a lot of work in this area and can give youmore information if it will help, but sooner or later, everyone will agree that making a "dustproof barrier"is very difficult and will cause severe economic hardships on the ice machine companies.

However, putting a HEPA filter system on the ice machine is relatively easy and cheap. It also provides abetter level of protection for ice because in addition to creating a dustproof barrier, the ice is surroundedby air that has been cleaned of any particles instead of the relatively dirty ambient air.

In NSF Policies 2004.pdf in Section 13: Patent in NSF Standards it states in part:

"a license will be made available to applicants under reasonable terms and conditions that aredemonstrably free of any unfair discrimination."

Currently we are working with Ecolab to set up a service agreement for ice machines that have HEPA


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Now it could be that I am wrong and the ice machine companies can reasonably comply with FDA FoodCode 4-204.18 by installing a dustproof barrier, (without running into our patents, of course) but I doubtit. In any case, if you suggest that they should be compliant with FDA Food Code 4-204.18, they will letyou know how hard or how easy it is.

Lastly, I have been working on cleaning up ice machine designs for years and spent $ millions doing it. Allthe ice machine companies know me.

http://www.tampabay.com/news/business/finally-a-clean-ice-machine-says-tarpon-springs-inventor/1151052

and

http://www.manitowocfsusa.com/?xhtml=xhtml/eno/us/en/pressrelease/2006_01_05_enodis_focusses_on_technology_alliances.html&xsl=pressrelease.xsl

A major university, USF, is doing an independent study of the efficacy of HEPA filtered ice machines andthis is being directed by Dr Daniel Lim

http://usfweb2.usf.edu/abl/index.asp

I don't know if I am giving you too much or too little information. Please let me know if there is anything I

can do to help you in your process of handling this matter. Feel free to call or email.

Thanks,Robert AlmbladCEOOrigin Tech.727 742 9064


21/22

Badman, Lorna

From: [email protected]: Monday, September 26, 2011 8:06 AMTo: Badman, Lorna

Cc: Davison, PatrickSubject: website

Hi Lorna

I forgot to include the website for HEPA filtered ice machines. It describes the HEPA technology and theproblems it solves.

www.safeicehealthcare.com

Thanks,Robert


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Amedicalicemachinesexposuretococoapowder:

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