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Task Group on NSF/ANSI 12 Teleconference Meeting Summary February 28, 2012

This document is the property of NSF International (NSF) and is for NSF Committee purpose only. Unless given prior approval from NSF, it shall not be reproduced, circulated, or quoted, in whole or in part, outside of NSF.

Participating members: Jim Brady (Wawa) Matt Allison (Scotsman Industries) Dan Bottens (IMI Cornelius Inc.) Daryl Erbs (Manitowoc, Inc.) Jim Frantz (Follett Corp) Mike Kohler (NSF) Absent members: Tony Gagliardi (Consultant Public Health)

Howard Ricketts (Ice-O-Matic) Stephen Schaefer (Hoshizaki America, Inc.) Todd Stephens (South Carolina Dept. of Health) Steve Tackitt (Barry-Eaton District Health Department)

Secretariat: Lorna Badman (NSF)

Participating observers: Robert Almblad (Origin Tech Center) Daniel Fenlon (Manitowoc, Inc.) Kevin Fink (Scotsman Industries) Deirdre Flynn (NAFEM) Mark Mittleman (Scotsman Industries) Art Miller (Scotsman Industries) Mike Rind (Origin Technologies) Supplemental Materials Referenced FE-2011-4 Condenser Unit Separation FE-2011-4 Supplements TG Final Draft Action Items:

Dave Richards (Origin Technologies) Charlie Souhrada (NAFEM) Ron Sobian (Legacy Companies) Larry Thompson (Sales) Ewan Todd (Ewan Todd Consultants) Bob Weber (Ice-O-Matic)

J. Brady will write an issue paper to be submitted for discussion at the June 2012 annual JC meeting on air flow (positive/negative pressure) through ice machines. Discussion L. Badman read the antitrust statement and took roll. J. Brady welcomed everyone and reviewed the meeting agenda. J. Brady moved to discussing the committee purposes. An outline is included below: 1

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a. Task Groups i. Specific to particular types of Equipment and Standards ii. Technical in nature to understand the scope of the issues submitted as they relate to equipment design therefore membership is heavily weighted on the manufacturer end with some representation from end users and regulatory. They do not set the standards but submit their findings and recommendations to the Joint Committee on Food Equipment. If the issue is not resolved at the task group level or if for any reason further direction is needed, the issue can be forwarded to the Joint Committee b. Joint Committee i. Consists of equally divided membership of regulatory, manufacturers and end users. ii. They are the ones who act of task group information and recommendations. iii. They may at times refer the issue back to the task group with specific directions on how to proceed or they may upon approval submit their recommendations to the CPHC. c. Council of Public Health Consultants i. Consists of over 30 regulatory agencies including the FDA. They also have a technical committee who analyze the recommendations and approve, reject or make further recommendations to the JC. So all certified standards get a thorough regulatory review before approval. d. Chairperson i. Sets agenda based on submitted material and needed feedback ii. Facilitates the meeting J. Brady moved to discussing the ground rules for the teleconference which included identifying yourself prior to speaking, do not interrupt the speaker and the issue described in the issue paper is the topic of discussion. J. Brady described that an issue paper is submitted to propose a change to a Standard. L. Badman indicated once the Standards Department receives an issue paper, it is given a tracking number and sent to the Joint Committee Chair for review. The Joint Committee Chair has the following options: to draft a ballot, have a task group formed or send to an existing Task Group, or hold the issue until it can be discussed in an open forum at the next Joint Committee meeting. J. Brady read issue paper FE-2011-4 Condenser Unit Separation into the record. The issue paper is included at the end of the summary. J. Brady added the following additional information:
NSF/ANSI 12 Automatic ice making equipment excerpt 5.17 Entry ports

Entry ports through which piping, thermometers, equipment, rotary shafts, or other functional parts enter into a food zone shall be sealed at the point of entry or shall be protected by a deflecting apron. Condensing compartments shall be sealed from the ice making compartment. NSF/ANSI 170 Glossary of food equipment terminology excerpt 3.179 sealed: Manufactured without openings, to prevent entry or leakage of liquid or moisture.

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The TG has been given allot of information. At this time J. Brady feels the TG should hear from the manufacturers and regulators. J. Brady called on the manufacturers in alphabetical order according to the roster. Manufacturer Feedback on the Stated Issue Scotsman Ice Machines The following was read by Mr. Fink during the teleconference. NSF requested Scotsman Ice System to provide the language below for inclusion in the summary:
OpeningRemarks  x Scotsman industries is a leading company and the safety of our products is critical to our customers and to our success. We have been developing and manufacturing ice machines for over 60 years. So, we take the claims that Mr. Almblad has made very seriously. We appreciate the opportunity to address Mr. Almbladserroneousclaimsandmischaracterizationsthataremeanttoservehiscommercialpurposes  Assuch,  o Wehaveperformedextensivetestingofourmachines. o Wehavereviewedtheissuedocumentandthematerialsofferedinsupportindetail. o WehavereviewedtheFDAFoodCodeandNSF12. o We asked Dr. Miller and Dr. Mittelman, highly qualified experts on food safety and public health issues,toadviseus.  x Dr. Art Miller has over 35 years of experience with the USDA, the FDAs Center for Food Safety and Applied Nutrition, and food safety consulting. At the FDA he was the Senior Science Advisor to the Retail Food Team and also served as FDAs Advisor to the technical council of the Conference for Food Protection, which formulates recommendations for changesintheFoodCode.  x Dr. Marc Mittelman is a microbiologist with over 25 years of experience with microbiological contamination detection, including work with companies that make medicaldevices,focusingonbiofilmpreventionandinfectioncontrolstrategies.  x WeseeabsolutelynothingtowarrantanychangetoNSF12.  o Letmetakeyouthrusomespecificdetails o First,ourtestingrefutesMr.Almbladsclaims. x Inparticular,hisclaimthatgasesarebeingsuckedfromfloordrainsintotheequipmentis justflatwrong.Noneofourmachinesdothis.  x Healsomakesspecificclaimsaboutairflowthroughthefoodzoneonnuggeticemachines used for patients in hospitals. We have tested our nugget ice machines and found no air beingblownorpushedthroughthefoodzonebythecondenserfanonanyofthem.None. 

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Second, our experts tell us that there is no evidence of airborne particles contaminating ice machinesandcausingillness. x Mr. Almblad has no scientific or medical evidence, and our experts cannot find anything in any medical or scientific study, describing a single occurrence in which airborne contaminationinfectedanicemachineandcausedanillness.  x There are over 2 million ice machines in service. They have proven to be extremely safe over decades of use when proper sanitation practices are followed. There is simply no probleminthefirstplace. x If it would be helpful to the task group, our experts, Dr. Miller and Dr. Mittelman, are available today to answer questions on food safety and health claims made by Mr. Almblad.

 o Finally, Mr. Almblad misinterprets the FDA Food Code to suit hiscommercial purposes. The fact is thatourmachinesdohavedustproofbarrierswithinthemeaningoftheFDAFoodCode. x The Food Code makes it clear that the purpose of the dustproof barrier is to protect the food zone from dust that is accumulated and blown about by the condenser fan.  Thats spelledoutinAnnex3oftheCode.  x All of our machines have walls that physically separate the condenser from the food zone. Those walls do just what the Food Code requires  they prevent dust in the condenser compartmentfrombeingblownintothefoodzonebythecondenserfan. x  x TosummarizeThereissimplynoreasontochangeNSF12 Our machines are NSF 12compliant and NSF 12 is completely consistent with the FDA FoodCodeinthisrespect.

K. Fink indicated Scotsman Industries has seen Mr. Almblads video. J. Brady asked Scotsman how the cocoa powdered got up into the ice bin and why Scotsman is claiming this cannot happen. Scotsman responded that their machines were tested in house and they did not measure any airflow through the drain in any of the various configurations. J. Brady requested that manufacturers identify what they think was happening in the video and if ice machines have been reported as a problem.. IMI Cornelius Inc. D. Bottens indicated his company does not make bench type cubers. IMI makes sealed continuous ice makers (flaker type machines). IMI does not have the potential to have this issue based on their type of ice makers. D. Bottens is unaware of any field issues with their machines. Manitowoc Ice Inc. D. Erbs indicated that K. Fink summed up the issues nicely. Manitowoc takes great care in manufacturing their machines. Design configurations do not allow air to get up into the machines. Manitowoc complies with FDA Food Code and NSF/ANSI 12. Their machines are listed with NSF International. Manitowoc has 4

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not had any field reports on their machines relating to the issue Mr. Almblad has raised. The video shows a number of different situations. It appears to be in a lab setting and a vacuum simulating device might have been used to create certain situations. This situation does not represent real world situations. More information regarding the testing needs to be known. Sanitization for ice machine covers several dimensional including the constructions, the IPC procedures used etc. This seems to be a narrow facet. Manitowoc does not feel additional language is needed because the Standard already addresses the issue. Ice can become contaminated in several different manners such as human contact, scoops & other accessory items. Ice contamination is rare. Follett Corp J. Frantz is in agreement with what the previous manufacturers have stated and does not see a need to make any modifications to NSF/ANSI 12. Mr. Almblads issue is currently covered by the language included in the Standard today (section 5.17). Ice-O-Matic H. Ricketts indicated that Scotsman addressed their concerns. Hoshizaki America, Inc. S. Schaefer thanked K. Fink & D. Erbs for their comments. Hoshizaki America has supplied ice machines to the US for the last 30 years and safety is their utmost concern. Hoshizaki America would like to add 2 additional statements to the discussion. 1. There is no evidence from the restaurants that this was a critical design flaw. If the area was of critical concern, it was so noted. If a dust proof barrier was missing it was corrected. What & where is the evidence of the problem? Did the owner of the machine not have something missing or inappropriately attached? This does not seem to be an issue in the field. 2. Ice machines are sealed. Hoshizaki America has not been able to replicate how air is getting into the machine. The condensers are separated from the ice making units. It appears the cocoa is bringing brought into the dispenser, bin but do not how it is getting in. Hoshizaki America would like to see further research completed. Hoshizaki America cannot replicate Mr. Almblads results. R. Almblads response to the Manufacturers Feedback R. Almblad stated cocoa powder was used because the military uses cocoa powder in their dist proof barrier tests. Generally speaking, there is a known problem with air borne contamination. Subway and other restaurants that have yeast in the air clean their machines more often due to the yeast. It is well known yeast gets into the machines. Many ice machines are on lease and are leased out to various locations. Locations with yeast in the air pay more for their lease because of the contamination concern. For the manufacturers to deny this fact is wrong. Air borne contamination is a well known fact. This is purely physics. Mr. Almblads company had no way of knowing that air was moving through the food zone. It was in attempt to add a HEPA filter into the ice machine that this was discovered. The FDA was aware of this issue and required that a dust-proof barrier between the condenser and the ice making unit was needed. Air should not be flowing through this area. It is bad enough that ice sits for 3 4 5

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days without it being eaten. Having air flow through this area is even worse. This why the FDA created a recommendation/requirement for a dust proof barrier to keep these areas separated. Mr. Almblad indicated that all the testing done by his company has found air borne contamination in way or another. There are various types of ice machines. Some of the machines were worse than others. The testing demonstrated all the machines were contaminated. The test instruments used in clean rooms etc. were used in the testing. Cocoa powder was used as a substitute for microorganisms and calibrated instruments such as a certified particle counter and device for measuring air flow were used. No sub-standard machines were used and they were not tricked. Off the shelf ice machines were used in the testing. Mr. Almblad does not understand the position the manufacturers are taking unless it has to do with the cost to fix the issue. Mr/ Almblad did not create the problem. He did discover the problem and is now trying to resolve the problem. For the last 6 years, Mr. Almblad has spent millions trying to resolve the problem. This is a known problem that needs to be resolved. Studies going back 40 years show that eating food items in a dark place that is wet and not protected from the air let alone blowing through the area. A problem exists here everyone knows it. Mr. Almblad stated he knows the ice machine manufacturers have worked hard over the past several years to keep their ice machines clean. In his opinion, no one was aware of the air blowing the machines. If this occurred in a refrigerator without the condenser unit being separated, it would be seen in the energy costs. Mr. Almblad is not blaming the ice machine manufacturers or feels that this was done intentionally. It is no different than backing out of your drive way and hitting your neighbors car. The problem needs to be fixed. Mr. Almblad inadvertently found that air was blowing through the food zone. The FDA was aware of this issue and included a requirement in the Food Code to eliminate this problem. Mr. Almblad indicated the manufacturers were helpful to him when he was trying to solve this issue. Regulatory Feedback on the stated issue and manufacturer feedback J. Brady asked K. Fink to summarize his statement for the regulatory participants. After his summary, Dr. Mittelman and Dr. Miller added the following: Dr. Mittelman, a consultant to Scotsman Industries, spoke to the air borne contamination in ice. This is not a well known or documented issue. Dr. Mittleman indicated he has read the papers reference by Mr. Almblad. In rare occasions where ice contamination has occurred, the contamination has been due to poor sanitization practices, scoop contamination or dirty water feeding an ice machine. Poor sanitization practices etc affect all equipment and industries. There is no documentation linking contamination to air-borne contaminants. This is not a well known problem. Repeating that air-borne contamination is a problem over and over does not make it so. Dr. Miller added while he cannot speak for the FDA, he did work for the FDA. A fair amount of his time was focused on retail food issues. He served as Sr. Advisor for retail food team at CFSAN. During his time at the FDA this never came up. Dr. Miller would characterize Mr. Almblads statement regarding this being a well known problem to the FDA as false. His statement regarding the FDA including this statement 29 years ago in the Food Code simply reflects the fact that FDA has been providing Model Guidance since the 6

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1930s. The Food Code, as known today, was formulated in 1983. It is Dr. Millers understanding today that this statement was carried from the older public health documents and grandfathered into the Food Code. J. Brady noted that there is a link provided to the studies referenced by Mr. Almblad. Mr. Almblad was provided the opportunity to respond to Dr. Mittelman and Dr. Miller. On the subject of this issue being well known, air borne contamination in ice machines was not well known. What is well known is that air borne contamination existed and still exists. This is one pathway to infection. The CDC does not have a requirement for tracking down air borne contamination in ice machines. Mr. Almblad submits that if air borne contamination ice machines was known by the early CDC other researchers (movement of air through the food zone of an ice machine) that their conclusions and research studies would come out differently. Mr. Almblad stated this was his speculation and is not included on his website. His website states that air borne contamination is well known in many cases and circumstances. Mr. Almblad didnt mean it was well known by everyone that air borne contamination in ice machines exists and people are getting sick. It is quite the opposite. Those doing research in the last 30 40 years were unaware that air blows through either positively or negatively in the ice machines. This is now known and research can be conducted to further research the issue. Todd Stephens Based on the manufacturer feedback, the issue as discussed and your background/experience in the regulatory field, T. Stephens indicated at this time he does not believe a change is needed to the Standard. This should be further researched but there is not enough science to elicit a change at this time. Steve Tackitt S. Tackitt, based on the information provided, asked what makes the bin accessible to dust. S. Tackitt indicated for there to be air flow, whether positive or negative, voids must exist. On todays teleconference, manufacturers have indicated there are barriers in place between the condenser and the ice making unit. What makes it accessible and where are the voids located? Mr. Almblad responded that each ice machine is different and the voids are located in different locations. The basic physics is there. There is a condenser unit blowing air in or out of the combined unit ice machine. A positive or negative airflow is created in the condenser (in the mechanical zone) which allows the air to either be pulled or pushed through the food zone. The voids are holes that connect refrigeration lines through the pusher (pushes the ice out), the top, sides and bottom of the ice machine. This is where the seal is needed between the condenser unit and the food zone. This area is not dust proof or air proof. It allows the passage of air. At the highest rate of air moving through was 900 ft/minute and went down from there depending on the unit. The problem is there are voids between the condenser unit and the food zone, which is where the air is pushed or pulled through the food zone. Mr. Tackitt stated realizing that an ice machine just by design and operation is subject to air contamination, not just through a condensing unit zone but by opening the bin, sliding the door. The integrity is compromised. The ice bin area is subject to not only air contamination but external contamination (human, syringes etc). Even though your product would place this under a positive pressure, once the opening is exposed there are other ways ice can be contaminated not including the void areas in the condensing unit. How can the deduction be made that the air is causing the contamination and not the external factors? 7

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Mr Almblad responded that Mr. Tackitt was correct. Over the years ice machines in category 4 or higher areas have been a combination of dispenser and ice making unit. There is no longer the opportunity for syringes, hands etc to come into contact with the ice. This has been an ongoing modification seen in the last 30 40 years. You are even seeing dispenser units in hotels. Accessing the ice via a persons hand is a very dangerous situation. In Mr. Almblads discovery where access exists, air is getting into the food zone and negative pressure can draw air/gases from drains into the food zone. People cannot be trained to solve this issue. Technology has improved over the years. Mr. Almblad does not believe that category 4 areas allow an open bin ice machine. The infection control manager would never allow this type of an ice machine to be in this area. A dispenser is required in category 4 areas. Mr. Almblad is unaware of anyone looking at an ice bin and air flow. K. Fink responded to Mr. Almblads statement regarding the gases from the drain getting into the food zone. In the testing Scotsman Industries has done, gases from a drain have not gotten into the food zone. While he is not familiar with all machines in the industry, all the manufacturers on this teleconference indicated they could not duplicate Mr. Almblads results. The methodology behind the testing is being called into question. Dr. Mittelman added that in the rare cases when an ice machine was associated with a patient infection, the contamination has come from the water supply, in proper sanitization of the unit, contaminated scoops etc. The source of the contamination was known and was not the air in the food zone. In each case, even those on Mr. Almblads website, the contamination sited was well understood not air. If the papers are read carefully, air is not stated as the cause of contamination. Mr. Almblad indicated that someone in the microbiological business put together the studies listed on his website. The Johns Hopkins study by Gabo was mentioned. Mr. Almblad indicated all the studies he has reviewed he knows that air was being blown through the ice machine and the water source etc was not the cause of the contamination. The researchers have been trying to figure out why there was contamination in the machine when there was no source of contamination. Mr. Almblad has studied the methods they used and determined they did not look for air contamination because they did not think air was moving through the ice machine. This has not been looked at for over 30 years. This is new and researchers will be looking for air contamination now. The drains and sinks where the surgeons have washed their hands have been designed because of air borne contamination coming up from the drain. There is no sucking, blowing etc in this application. There is a drain under each ice machine. The drain is one of the most dangerous environments to have with a drain line. If there is no air blowing through the food zone, this will improve the situation but will not eliminate the situation. The ice machines studied by Mr. Almblad have had some air flow through the food zone because a dust proof barrier does not exist between the condenser unit and the food zone. This is just plain physics. Gas is moving between the 2 zones because of the condenser unit. If the condenser unit is turned on, you will see air movement in the food zone. If the condenser unit is turned off, there will be no air in the food zone. This is very clear. There are many instruments, such as COPA, that will measure the air flow. The manufacturers participating on this teleconference today were not using this type of instrument or the instrument was not calibrated appropriately. S. Tackitt indicated the reference that Mr. Almbald is referring to is GEBO 2002 publication Clinical Infectious Diseases. S. Tackitt does not see a reason to modify NSF/ANSI 12 or the Food Code. From a local regulatory perspective, a contamination problem exists in the ice bin and has been documented as a people problem 8

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and the fact it is not cleaned properly, contaminated scoops, human contact, contamination on a grommet etc. More research needs to be conducted to determine if a problem exists. The void areas need to be found but this does not necessitate a change to the Standard or Food Code presently. Yes, the contamination could be air borne. Mr. Mittelman stated that the mycobacterium problem in GEBO 2002 publication Clinical Infectious Diseases was due to a contaminated water source. This issue was resolved when the water contamination was rectified. There has been no more contamination issues since this was corrected. It is important that TG meetings contain honesty and scientific fact. This was not an air borne contamination problem. Action as it relates to the Issue Recommendation Based on the feedback, the potential issue may not be as stated in the issue paper. J. Brady suggested submitting an issue paper addressing the issue discussed on the teleconference today. The initial issue was the dust proof barrier and what it seems to be is more of a water contamination issue. Water contamination is rare. Human contamination is a bigger issue. The use of technology has eliminated the contamination issues with hands, contaminated scoops etc. As far as airborne contamination is concerned, Mr. Almblad submits that air moving through the ice machine is new. It is not new that ice machines get contaminated. Air borne contamination exists and should be taken into serious consideration because this is one pathway for contamination. People near death, eat ice. Air borne contamination needs to be paid attention to. Ice machines in category 4 situations do not have contaminated water or scoops. 99,000 people are dying from HIAs. Paying attention to this good idea and whether air is moving through the food zone is important. Thinking that the air is not moving, and the cocoa powdered is a figment of an imagination is not a smart conclusion. From microbiological perspective and a category 4 situation, this needs to be paid attention to. T. Stephens would like to see Mr. Almblads methods used by NSF International to see if the results can be replicated. The areas in questions are areas that do not get cleaned a drain line is a discharge. T. Stephens & S. Tackitt maintain a change is not needed at this time. Public health is always looking at ways to eliminate risk. Questions have been raised that need to be further researched. It was suggested that NSF should look at some ice machines and determine if voids are present. Appropriate measuring devices should be used to determine if a positive or negative pressure passes through the ice storage bin when the condenser unit is operating. M. Kohler indicated that NSF could look into some the testing. It is possible some of the tests run on biosafety hoods could be used. An airflow study could potentially be done. This information could then be reported to the TG or Joint Committee. Manufacturers would need to provide ice machines for testing. S. Tackitt added that if the testing demonstrated air was present, he is not convinced the air is a bigger problem than human contamination. Mr. Almblad would like to see third party verification. Human contamination is no longer problem because of the technology in the field. J. Brady wants to ensure the information gathered is what is needed to help the regulatory community make a decision. S. Tackitt believes the direction being discussed would be helpful but until the data elicits a need 9

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for a modification to the Standard, a modification should not be made. T. Stephens indicated that just because air is present does not solve the issue. If sealants, grommets etc fixes the problem, change would not be needed. This would provide another option for manufacturers to fix the issue. J. Brady indicated this could be specific to certain ice machines. He has looked at ~ 5 different ice machines. Because of the differences in the machines, cleaning the machine may or may not fix the issue. If research is completed, J. Brady wants to ensure it the correct research. M. Kohler clarified that NSF could do testing. He indicated that it seems unclear if the data received from this study would provide the information required. The issue paper submitted was based on dust and the TG is discussing air, which is somewhat related. In M. Kohlers mind the air contamination is a different issue. He suggested that a new issue paper addressing air flow could be submitted for discussion at the June Joint Committee meeting. If the Joint Committee feels that testing would be valuable, the TG could proceed from there. E. Todd indicated that based on the discussion today, he does not feel that an issue does not exist. So he feels that the Joint Committee should be consulted and determine if additional testing is needed. The TG unanimously agreed that no modification is needed to NSF/ANSI 12 at this time based on the issue paper submitted. FE-2011-4 has been addressed and is no longer in needing further discussion. J. Brady will submit a new issue paper on the air flow issue through the ice machine bin for discussion at the upcoming Joint Committee meeting. The issue paper will be based on todays teleconference. L. Badman explained that the Joint Committee meeting is open and anyone can attend via teleconference or in person. J. Brady thanked everyone for their participation and hopes to see everyone in June.