05-09 Doc #20-1 Attachment NSF Minutes

7/30/2019 05-09 Doc #20-1 Attachment NSF Minutes

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EXHIBIT A

Case: 1:13-cv-01297 Document #: 20-1 Filed: 05/09/13 Page 1 of 11 PageID #:65


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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)

Howard Ricketts (Ice-O-Matic)Stephen Schaefer (Hoshizaki America, Inc.)

Todd Stephens (South Carolina Dept. of Health)

Steve Tackitt (Barry-Eaton District Health

Department)

Absent members:

Tony Gagliardi (Consultant Public Health)

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)

Dave Richards (Origin Technologies)

Charlie Souhrada (NAFEM)

Ron Sobian (Legacy Companies)Larry Thompson (Sales)

Ewan Todd (Ewan Todd Consultants)Bob Weber (Ice-O-Matic)

Supplemental Materials Referenced

FE-2011-4 Condenser Unit Separation

FE-2011-4 Supplements

TG Final Draft

Action Items:

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:



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a. Task Groups

i. Specific to particular types of Equipment and Standardsii. 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 FoodEquipment. 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 Committeei. 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 onhow 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 makefurther 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 ofdiscussion.

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 openforum at the next Joint Committee meeting.

J. Brady read issue paper FE-2011-4 Condenser Unit Separation into the record. The issue paper is includedat the end of the summary. J. Brady added the following additional information:

NSF/ANSI 12 Automatic ice making equipment excerpt

5.17 Entry por ts

Entry ports through which piping, thermometers, equipment, rotary shafts, or other functional parts enter intoa food zone shall be sealed at the point of entry or shall be protected by a deflecting apron. Condensingcompartments 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 themanufacturers 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 Scotsmanindustriesisaleadingcompanyandthesafetyofourproductsiscriticaltoourcustomersand

tooursuccess.Wehavebeendevelopingandmanufacturingicemachinesforover60years.So,wetake

the claims thatMr.Almblad hasmade very seriously.We appreciate the opportunity to addressMr

Almbladserroneous

claims

and

mischaracterizations

that

are

meant

to

serve

his

commercial

purposes

Assuch,

o Wehaveperformedextensivetestingofourmachines.

o Wehavereviewedtheissuedocumentandthematerialsofferedinsupportindetail.

o WehavereviewedtheFDAFoodCodeandNSF12.

o WeaskedDr.MillerandDr.Mittelman,highlyqualifiedexpertsonfoodsafetyandpublichealth

issues,toadviseus.

x Dr.ArtMillerhasover35yearsofexperiencewith theUSDA, theFDAsCenterforFood

SafetyandAppliedNutrition,andfood safety consulting.At theFDAhewas the Senior

ScienceAdvisortotheRetailFoodTeamandalsoservedasFDAsAdvisortothetechnica

council of the Conferencefor Food Protection, whichformulates recommendationsfor

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,our

testing

refutes

Mr.

Almblads

claims.

x Inparticular,hisclaimthatgasesarebeingsuckedfromfloordrainsintotheequipmentis

justflatwrong.Noneofourmachinesdothis.

x Healsomakesspecificclaimsaboutairflowthroughthefoodzoneonnuggeticemachines

usedforpatients inhospitals. Wehavetestedournugget icemachinesandfoundnoair

beingblownorpushedthroughthefoodzonebythecondenserfanonanyofthem.None.



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o Second, our experts tell us that there is no evidence of airborne particles contaminating ice

machinesandcausingillness.

x Mr.Almbladhasnoscientificormedicalevidence,andourexpertscannotfindanythingin

any medical or scientific study, describing a single occurrence in which airborne

contaminationinfectedanicemachineandcausedanillness.

x Thereare

over

2

million

ice

machines

in

service.

They

have

proven

to

be

extremely

safe

over decades of usewhenproper sanitationpractices arefollowed. There is simply no

probleminthefirstplace.

x If itwould be helpful to the taskgroup, our experts,Dr.Miller andDr.Mittelman, are

available today to answer questions on food safety and health claims made by Mr

Almblad.o Finally,Mr.AlmbladmisinterpretstheFDAFoodCodetosuithiscommercialpurposes.Thefactis

thatourmachinesdohavedustproofbarrierswithinthemeaningoftheFDAFoodCode.

x TheFoodCodemakes itclearthatthepurposeof thedustproofbarrier istoprotectthe

foodzone

from

dust

that

is

accumulated

and

blown

about

by

the

condenser

fan.

Thats

spelledoutinAnnex3oftheCode.

x Allofourmachineshavewallsthatphysicallyseparatethecondenserfromthefoodzone

Thosewalls dojustwhat the Food Code requires theyprevent dust in the condenser

compartmentfrombeingblownintothefoodzonebythecondenserfan.

x OurmachinesareNSF12compliantandNSF12 is completely consistentwith theFDA

FoodCodeinthisrespect.

x TosummarizeThereissimplynoreasontochangeNSF12

K. Fink indicated Scotsman Industries has seen Mr. Almblads video. J. Brady asked Scotsman how thecocoa 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 icemakers. 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 manufacturingtheir 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



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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 havebeen 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 criticaldesign 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 somethingmissing 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 researchcompleted. 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 otherrestaurants 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 todeny 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



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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 usedin the testing.

Cocoa powder was used as a substitute for microorganisms and calibrated instruments such as a certifiedparticle 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 knowsit.

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 thisissue 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 sanitizationpractices, 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 doesnot 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 timeat 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



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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 ofthis 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. Almbladsubmits 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 websiteHis 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 StandardThis 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. Tackittindicated 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 toeither 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 allowsthe 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?



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Mr Almblad responded that Mr. Tackitt was correct. Over the years ice machines in category 4 or higherareas 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 andnegative 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 inthis 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 hasreviewed 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 inthe 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 beendesigned 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 improvethe 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 notusing 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



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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 foundbut 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 InfectiousDiseases 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 icemachine 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 havecontaminated 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 acategory 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 icestorage 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. Manufacturerswould 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 biggerproblem 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



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05-09 Doc #20-1 Attachment NSF Minutes