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E. Coli Confession: Part 8

Editor’s Note: This is the eighth installment in a series written by John Munsell of Miles City, MT, who explains how the small meat plant his family owned for 59 years ran afoul of USDA’s meat inspection program. The events he writes about began a decade ago, but remain relevant today.

The Food Safety and Inspection Service’s justification for saying I could not lower the temperature inside my processing room to 45 degrees was that I didn’t have a copy of an approved scientific study in my files proving a 45-degree temperature was acceptable. However, if I increased it to 50 degrees, FSIS would find no fault. 

In other words, plant management can’t make any decision to change operations until they can find a scientific study that validates the efficacy of every specific decision.

Attempts to persuade the agency to re-implement National Standards to provide “safe harbors” to plants as they establish meat production protocol have been totally fruitless.

Instead, in the absence of common sense national standards (a benefit of deregulated HACCP), FSIS can badger and intimidate small plants. Mind you, the agency doesn’t provide answers, but merely rejects numerous common sense decisions plants make, only to hagride plant owners to the point that the owners close the doors and walk away to circumvent this senseless scenario.  Please don’t get me wrong here; although the vast majority of inspectors believe the agency desires to close down small plants, I disagree.

My perception is that FSIS could care less if small plants continue to exist. Instead, FSIS wants to be relieved of the responsibility of providing inspection services to small plants. The best way to accomplish this is to torment and harass small plant owners, especially with worry and dread, until the owner gets so exasperated s/he walks away. Another win for public health! No, another win for an agency that only wants to provide deregulated service to the largest plants. Not only would the agency’s payroll budget decrease, but also the agency would no longer have to worry about its thousands of inspectors revealing details of the agency’s failed HACCP theory to the public. Much easier to micro manage a smaller work force.  

A comparison of the relative number of agency enforcement actions at small plants versus large plants is easily seen by comparing the number of Noncompliance Records (NRs) at some large plants versus small plants in 2010. Through a recent Freedom of Information Act request, FSIS provided me the number of NRs at various large plants in the U.S. At the following three companies, I eliminated the “outliers,” that is, the highest and lowest figures, some of which were way above or below the average of the other plants:

Tyson 14 Plants 114 Average

Cargill 7 Plants   71 Average

Smithfield Packing   3 Plants 53 Average

Both National Beef and Seaboard Foods have only three plants each, so I did not eliminate any outliers.

National Beef 3 Plants 87 Average

Seaboard Foods 3 Plants 43 Average

With the exception of Seaboard Farms’ bacon plants, the large plants listed above kill thousands of beef, pork or chicken daily, yet they average only 43 – 114 NRs annually.

The number of NRs issued at two small plants in Montana in 2010 provide us food for thought.  FSIS assessed 158 NRs at Ranchland Packing in Butte and 115 at Stillwater Packing in Columbus.  

In four meatingplace blogs in January through March 2011, former USDA Under-Secretary for food safety Dr. Richard Raymond discussed agency behavior at these two Montana plants, generating a record number of meatingplace responses.  Following Dr. Raymond’s embarrassing revelations, FSIS immediately decreased the number of NRs at these two small Montana plants by over 50 percent. The agency also retroactively rescinded many NRs that had been closed out in 2010 at the two plants.  

Please refer to Part 4 of this narrative, which explained that Nebraska Beef filed suit against FSIS because it had been assessed 58 NRs, which its complaint alleged constituted evidence of the inspectors’ bias. If Nebraska Beef, with 1,100 employees, is justified in filing a bias claim against FSIS because of 53 NRs over four months, should a small plant with only 12 employees which receives 158 NRs in 12 months be likewise justified?

However, FSIS apparently has no concerns over well-deserved litigation potentially stemming from small plants, perhaps because the small plants lack the political clout and financing to challenge the agency. Small plants are much easier enforcement prey.

The volume at these two Montana plants is incredibly small, and their kill floor speed is negligible. These two plants have not invested millions of dollars to determine how they can remove visible fecal material from the kill floor, because the production lines move so slowly workers can readily observe and quickly remove any contaminant.

Likewise, their HACCP Plans lack the multitude of independent third party scientific theories that the biggest plants proudly parade. The kill floors at these two small plants lack the steam pasteurization interventions employed at the high-speed plants, because the small plants don’t need the intervention.

Back to my 50 degree temperature problem with FSIS.  At the time the agency was hassling me on this issue, FSIS just didn’t seem to have copies of any scientific articles available to assist small plant ignoramuses like me. The agency was fully cognizant of a number of temperature-related articles, but wouldn’t divulge them. Much more fun to watch plant owners squirm and sweat blood!

When the agency created the position of Consumer Safety Officers (CSOs), the agency instructed the CSOs to make such scientific demands, but to NOT provide copies of the required scientific articles. How do I know this? Because dozens of agency employees have told me so. Other plant owners related the same sad tale. Admittedly, when the agency morphed CSOs into Enforcement, Investigation and Analysis Officers (EIAOs), the agency did an about-face, and instructed the EIAOs to proactively provide copies of such articles, or at least the links required to access the articles.  

So, for several weeks the agency threatened enforcement actions against me for lowering my processing room temperature five degrees, and I steadfastly resisted to go back up to 50 degrees. For some unknown reason, the agency let this issue suddenly disappear, never to resurrect it again. One of the few battles I won. Perhaps the agency knew that their position on this was so petty, FSIS wanted to avoid a PR debacle if it ever went public.  

Do you perceive now what FSIS-style HACCP had devo
lved to? Instead of inspecting meat production lines, agency personnel were busy beavers inspecting written HACCP Plans, and ensuring that plants had an abundance of bullet-proof scientific articles justifying every decision appearing in the plant’s HACCP Plan.

Who cared if pathogen-laced meat was flowing down the production lines?  FSIS prefered to closely inspect the theoretical bases of all company decisions, dedicating precious time to auditing all company-generated paper flow and its library of scientific articles. 

Who cared about actual meat production lines?  As long as the written HACCP Plan appeared to be in order, FSIS assumed that all meat produced at the plant must be safe.  

A superlative example of how this played out came in the aftermath of a Federal Register Notice issued by FSIS on Oct. 7, 2002.  The notice required all meat plants to reassess their HACCP Plans to determine if E.coli 0157:H7 was a Hazard Likely To Occur.  As a result of our recall, and our experiencing four lab positives for E.coli O157:H7, I had already determined that E.coli O157:H7 was indeed a hazard likely to occur, and had taken numerous steps to address this hazard.  The Minneapolis DO had already dictated these changes during the four months of disputations in early 2002.  

In 2003, FSIS sent their CSOs (Consumer Safety Officials, supposedly the ultimate HACCP experts) into the field to determine if all plants were compliant with the agency’s demand to reassess HACCP Plans to determine if E.coli O157:H7 was a Hazard Likely To Occur. Two CSOs visited my plant from Sept. 15 to 18, 2003, not only to ensure my compliance, but also to review all details of my HACCP Plan.

One of the CSOs was already intensely familiar with my HACCP Plan, because he was the primary agency spokesperson for the Minneapolis District Office (DO) during the four months of negotiations with me in early 2002, the four months during which I was prohibited from grinding under the USDA Mark of Inspection.  

Some incredible agency demands were made of me during the four days the two CSOs were at my plant.

When they arrived, my “raw ground” HACCP Plan had six Critical Control Points — CCPs —  the points in the production line where we could intervene to prevent, eliminate or reduce pathogens to an undetectable level.

This narrative previously referred to consultant Dr. Helmut Blume, who provided services to my plant in 2002 to resolve my problems with the Minneapolis office.  Dr. Blume thought that it was totally unnecessary for me to have six CCPs in my “raw ground” plan, because in his view six CCPs were dramatic overkill. Many others in the industry agreed. 

However, because the Minneapolis DO had “suggested” (in other words, mandated) these six CCPs during our four months from hell, I had quickly implemented them into my HACCP Plan.

When the CSOs visited with me in September 2003, they also agreed that not only should I not have these six CCPs, but also stated that all six should be removed!  For some reason that will never be revealed, the Minneapolis DO did an abrupt about face on my HACCP Plan.  Apparently, science had changed (for the umpteenth time). This scenario again reveals that the agency was noncompliant with its previous promise that plants could write their own HACCP Plans, and that the agency can’t tell plants what must be in their HACCP Plans.

When agency EIAOs and other touring officials tell small plant owners to jump, we ask “how high?” Refusal to play this game enables agency officials to conduct a witch-hunt at the plant, and the agency always wins.

 I stayed late at work on Sept. 17, 2003, and made pencil changes that removed all six CCPs to fully comply with the “suggestions.” Upon their return to my plant the next day, they asked what CCP I then intended to use as a replacement for the six that had been removed.  I replied that I was not aware of any which would be appropriate.  One CSO then suggested that I list Salmonella as a Hazard Likely To Occur, and to control it with temperature.  I complied with his “suggestion,” and I now had but one CCP.   

And please remember that the six CCPs, which were removed, had originally been implemented because of mandates from the Minneapolis DO. Now, 15 months later, at the insistence of the newest agency visitors at my plant, I deleted all six CCPs, and replaced them with one, the details of which were mandated by these two CSOs.  Whatever had happened to the agency promise that each plant could write its own HACCP Plan, and that FSIS couldn’t tell plants what must be in their HACCP Plans?  

At the same time, the two CSOs stated that it was inappropriate of me to list E.coli O157:H7 as a “Hazard Likely To Occur.” I disagreed, stating that my plant had already experienced a recall for E.coli-contaminated meat, and had experienced four adverse lab reports that revealed E.coli O157:H7 at my plant.

I stated that if there was one plant in the country that should have concluded that E.coli O157:H7 was a Hazard Likely To Occur, it was MY plant. The two CSOs disagreed, yet again denying me the right to author my own HACCP Plan.  

Plants across the country already knew that if they disagreed with CSO suggestions, the plants were almost guaranteed to be issued a NOIE (Notice of Intended Enforcement) from the agency. A NOIE is an agency warning to a plant, stating that if the alleged violation was not resolved within 72 hours, the agency could withdraw inspectors, essentially closing the plant. 

Because of this historical fact, I submitted to all “suggestions” from the CSOs, and implemented their demands. Therefore, when the CSOs demanded that it was inappropriate for me to list E.coli O157:H7 as a Hazard Likely To Occur at my plant, I fully complied.    Although I had never experienced a positive sample of Salmonella at my plant, these two CSOs demanded that I must conclude that Salmonella is a Hazard Likely To Occur at my plant.  Conversely, although I had already experienced one E.coli O157:H7 recall and four adverse lab tests for E. coli at my plant, these two CSOs demanded that I no longer list E. coli O157:H7 as a Hazard Likely To Occur.

I have to wonder if this craziness was being dictated from top FSIS officials in D.C., but only the two CSOs can answer that question. Regardless of the source of these conflicting demands, it again shows that FSIS personnel regularly mandate what must be in individual plant’s HACCP Plans, but only at small plants. And, that their mandates are typically inconsistent with and contradictory to previous agency mandates. Science continually evolves!

My wife Kathryn participated in one of these meetings with the two CSOs. Kathryn discussed constantly changing, contradictory and conflicting demands from each new FSIS visitor to my plant, all of whom mandated changes to my HACCP Plan, while criticizing changes I had previously initiated at the demand of previous agency employees.

Exasperated, Kathryn finally asked, “Who is in charge here?”  After a long hesitation, one CSO admitted “Well … no one.” This CSO response reveals a central failure in FSIS-style HACCP:  FSIS lacks consistent standards, energizing each new FSIS visitor to unilaterally require whatever subjective bias s/he has, even though the newest mandate is diametrically opposed to all previous agency requirements. Plants’ decisions must be scientifically supportable, but agency decisions do not.  

During and immediately after this four-day session with these two CSOs, I maintained copious records of all events that transpired during the four days. I hope these records will be sub
poenaed in a future court proceeding, where the agency and their two CSOs can provide their side of the story.  

Another interesting agency action occurred during another CSO visit to my plant on March 13, 2002.  During this visit, as I unlocked the file and removed the HACCP Plan, the FSIS personnel saw a pistol in the file drawer. This pistol is used to shoot buffalo, and I kept it locked up for safe keeping.

The following week, Dr. Daryl Burden came to my plant again, and in his own words, stated that the agency had commenced a “Violence in the Workplace” inquiry against me. I was incredulous, and asked for an explanation. Dr. Burden stated that since I kept the pistol in the same drawer as my HACCP Plan, that agency personnel allegedly had felt intimidated.

The inquiry was concerned that I was subtly implying that if agency personnel asked to view my HACCP Plan, they might be looking down a pistol barrel instead.  I immediately relocated the pistol into another locked file.

Dr. Burden interviewed all pertinent agency field force, who essentially laughed in his face, and said they did not feel threatened in the slightest. Dr. Burden’s response to this alleged Violence in the Workplace inquiry included the following statement on March 22, 2002:

“I have never witnessed anything at Est 7679 which could at all be considered threatening or intimidating by the management, nor have I been able to find any record of such concerns in the past.”

This is but another example of FSIS concocting trumped-up charges against “rebellious” plant owners who attempt to stand up for their rights.  

    

Ask any small plant owner in America, who will admit that an agency official (CSO, EIAO, Front Line Supervisor, etc.) arrives at their plant, and “suggests” that numerous changes be made in the plant’s HACCP Plan.  Any attempt to object results in agency-sanctioned harassment and retaliation.  Therefore, we’ve all learned to implement whatever the agency mandates/suggests.  

Six weeks later, another agency official arrives, reviews the recently changed HACCP Plan, and requires that the recent changes be rescinded, and replaced with “suggestions” from the newest agency visitor. If the “suggestions” are not implemented, Noncompliance Reports and NOIEs are guaranteed.  So, we implement the “suggestions,” regardless of how frivolous

Subsequently, another agency employee shows up at our door, reviews our HACCP Plan (not the production line), and thoroughly repudiates the most recent agency-mandated changes, and mandates/suggests an alternative protocol. 

And think about it, folks.  As FSIS continues this façade, this shell game of ever-changing HACCP changes (most of which have zero connection to food safety), the agency continues to endorse the right of the large source slaughter plants to ship into commerce intact cuts of meat whose surfaces are liberally laced with E.coli O157:H7.

Remember, FSIS states that intact cuts of meat that are surface-contaminated with E. coli are NOT adulterated. Therefore, even if the agency successfully shutters all small plants, ongoing outbreaks and recurring recalls continue. Well FSIS, whom will you blame this time?  

I implemented HACCP in January 2000, a true believer in HACCP protocol. But as time went on, I witnessed serious discrepancies in the way that FSIS responded to issues in the field.  I slowly came to realize that I was living a lie, but couldn’t put my finger on the true source of the lie. I simply could not identify what was happening right before my eyes, it was so deceptive.

It wasn’t until August of 2009 that I was informed of the origin of the lie:  FSIS-style HACCP is not true HACCP!  Suddenly, all of the agency’s behavior made sense.  I am no longer living the lie.  Just as my understanding the enormous differences of FSIS-style HACCP compared to Pillsbury HACCP has enabled me to connect the dots to explain our ongoing outbreaks, my goal is that this report will enable all Americans to connect the dots revealing the agency’s intentional bastardization of scientific principles.

This shell game has allowed the agency to abdicate its legislative mandate to protect public health, and to use pseudo science as its justification.  

FSIS sowed the seeds of outright deception when it authored its faulty version of HACCP.  Consumers are now reaping repetitive outbreaks caused by the agency’s unscientific policies.   

This agency-sponsored conundrum also reveals the need for effective tracebacks to the source, instead of focusing agency investigations and enforcement actions at the downstream destination plants that unwittingly purchase meat that was previously contaminated with invisible pathogens.

Historical agency actions continue to reveal that the agency overtly prevents tracebacks to the true source of contamination, via intentional obfuscation of source evidence at the time of sample collection. The agency’s insulation of source plants from accountability virtually guarantees ongoing outbreaks and recurring recalls

Here we are, a full 13 years since the largest plants implemented HACCP, and we continue to experience a spate of ongoing outbreaks and recurring recalls.  For consumers’ sakes, FSIS must be forced to remove its head from the sand.

FDA and FSIS jointly hosted a public hearing on Traceback Protocol on Dec. 9 and 10, 2009, meetings which went all day, both days. One statement made by Jerold Mande, the FSIS Deputy Under Secretary of Food Safety, was as follows:

“We [FSIS] often don’t have all the information we need to protect public health.”

Finally, an admission by a high-ranking FSIS official that agency traceback protocol is inadequate. 

Not to be outdone by this two-day joint venture with FDA, FSIS was the sole host of a subsequent Traceback Hearing in D.C. on March 10, 2010.  In stark contrast with the FDA Hearing, this FSIS Hearing was completed in three and a half hours.

One of the audience participants who stepped up to the audience microphone with a statement was Scott Goltry, the vice president for Food Safety and Inspection Services at the American Meat Institute (AMI). While AMI membership is open to meat plants of all sizes, AMI primarily represents the interests of larger plants. One of Mr. Goltry’s comments was as follows:

“Except in the case of high event periods, AMI is unaware if a change to the trace back follow up sample procedure would have a significant improvement to public health.”  

In other words, improving trace back protocol would not benefit consumers. AMI concludes that definitive determinations of the true source of contamination, and agency enforcement actions at the source, would provide no additional benefits for public health purposes.

Instead, let’s just continue to assess full responsibility against the downstream further processors that unwittingly purchase previously contaminated meat, and maintain the agency’s current practice of insulating the source originating slaughter plant from accountability.  

To the agency’s credit, it issued Notice 58-03 on Oct. 8, 2010, entitled “Collecting Supplier Information At The Time Of Sample Collection For Escherichia coli (E. coli) 0157:H7 In Raw Ground Beef Products And Bench Trim.”  Sound familiar?  This is the same protocol that the agency demanded in the afore-mentioned email from FSIS headquarters in Washington, DC, on July 26, 2002, days before NBC News carried my story.

It’s the same pro
tocol which FSIS rescinded two months later, “for legal reasons,” as stated by an agency official. If FSIS utilizes a truly science-based meat inspection system, the agency would have demanded copious source documentation from day one of HACCP’s advent. Even when I had high school and college lab classes 40 plus years ago, we were taught the obvious need to document in real time all evidence to describe the ingredients that went into our lab project.  FSIS disagreed, until Notice 58-10 was released. After numerous embarrassing and painful outbreaks and recalls, FSIS is more willing to document source slaughter evidence.  

Is there a need for tracebacks? Consider this:  between Jan. 1, 2009 and Nov. 30, 2010, FSIS-conducted testing resulted in 64 positives for E. coli O157:H7. Of these 64 positives, 29 were from plants that did not slaughter and used only one source in the tested lot. Nearly 50 percent should have been easily traced to the source, but were not.  FSIS-style HACCP prohibits tracebacks to the true source.  

Tracing back to the true source, and then forcing the true source to implement meaningful corrective actions to prevent recurrences would greatly benefit public health, in spite of opposition from FSIS and AMI.

In fact, the idea of “prevention” is at the top of the priorities shared by the agency’s new Under Secretary for Food Safety, Dr. Elisabeth Hagen, and the agency’s administrator, Al Almanza.  To their credit, they have proactively embraced prevention as a means of promoting public health imperatives.

Theirs is an unpopular and dangerous position, diametrically opposed to the agency’s historical primary focus on “corrective actions” since HACCP’s advent in 1998.  Prior to the current focus on prevention, FSIS has been content to require corrective actions at downstream further processing plants, ignoring the need for prevention at the source.  

FSIS is currently launching a dynamic data analytics system called the Public Health Information System (PHIS), developed as part of the agency’s effort to collect, consolidate and analyze data.  The FSIS website makes the following statements about PHIS:

“It will integrate and automate our paper-based business processes – often found to be inefficient, time-consuming and limiting – into one comprehensive and fully automated data-driven inspection system.  PHIS will significantly improve the way FSIS detects and responds to foodborne hazards.


“PHIS will enable FSIS to respond more quickly when threats are realized.”

Only time will tell if PHIS will reveal when the agency unfairly targets individual plants for unusually high numbers of NRs. If so, the agency’s inappropriate actions against these two small Montana plants would be red flagged for the world to observe. A central issue within PHIS is whether FSIS officials will continue to enjoy carte blanche authority to perform such targeting, or will PHIS require accountability for all agency employees.

One feature being designed into PHIS, in proposal form now, would require inspectors to document onto their laptops source information whenever the inspector collects meat for microbial analysis at USDA labs.  If implemented as proposed, the following data will be documented for the source slaughter provider for the meat being sampled at the time of sample collection:

– Name and Establishment number of supplier

– Establishment Phone Number

– Establishment contact

– Name, Title, Email, and Fax #

– Supplier lot #

– Production dates

– Name of beef components used in implicated products

– Amount of lot

Previous agency data collection efforts have indeed collected statistics, which have not always forced the agency to initiate meaningful enforcement actions, or even beneficial conversations with impacted meat establishments.  An example is the agency’s STEPS system, or “System Tracking E.coli Positive Suppliers.”

Whenever a plant experiences an E. coli O157:H7 positive lab sample, or a recall for E. coli-contaminated meat, FSIS personnel have accumulated a list of all the source slaughter suppliers from which the impacted plant has purchased its products. All these suppliers are entered onto the STEPS data system as a “potential” supplier of the contaminated meat that caused the pathogen problem at the plant in question.

Over time, if one source slaughter provider’s name should reappear many times on STEPS, FSIS could then consider initiating some actions at the slaughter plant, such as a Food Safety Assessment (FSA), or an increased incidence of agency-conducted microbial sampling. 

 

In a July 2008 STEPS Reporting of “Suppliers Identified 3 or More Times” since FY 02, the highest reporting six plants were as follows, ranked by number of hits:

Nebraska Beef, Ltd. Est 19336 21

Beef Products, Inc. Est 19872 15

Moyer Packing Co. Est 1311 15

Greater Omaha Packing Co. Est 960A 13

Farmland Nat’l Beef Pk. Co. Est 208A 10

Gibbon Packing Est 5511 10

Questions I have which stem from data on this report can only be answered definitively by FSIS bureaucrats in Washington, D.C.  One question is a potential connection between Nebraska Beef’s 21 appearances in STEPS in July 2008, and Nebraska Beef’s two recalls in July and August, 2008, as reported on page 35 of this report.

I’d like to know what types of communications or enforcement actions, if any, were initiated by the agency with or against Nebraska Beef once the company’s name appeared on STEPS 10 times, let alone 21 times.  FSIS cannot claim that the two recalls were the agency’s actions, because the two Recall News Releases both mentioned that the recalls were due to a foodborne illness outbreak that on Aug. 8, 2008 included 31 cases in 12 states and Canada.  

FSIS continues to develop its technology allowing inspectors with laptops to accumulate reams of statistics. The real question that remains to be answered however is agency willingness to respond appropriately when it receives incontr
overtible evidence revealing that a source slaughter plant is shipping meat into commerce that is laced with enteric pathogens.

It appears that STEPS data have not generated meaningful agency response. Will PHIS suffer the same fate?  Will FSIS bureaucrats have the ability to manipulate numbers in the PHIS database?  Or to unilaterally remove discomforting statistics?  In order to maintain the agency’s semi-retirement comfort level, will FSIS be able to discredit embarrassing PHIS entries by inspectors by stating that the entries are but “personal opinion” or “hearsay”?  Will the agency destroy damaging evidence by claiming “the inspector had no right to make that statement”?  Past agency behavior gives us little reason for confidence.

The mere accumulation of damaging data is valueless if FSIS is unwilling to act on it.  

Another question I would pose to FSIS is what authority the agency has to initiate enforcement actions, even when in possession of damaging microbial evidence that proves that a source slaughter plant has shipped into commerce meat laced with enteric pathogens. 

FSIS sold its version of HACCP to the industry with the four promises listed earlier in this series. The agency promised that it would no longer “police” the industry, that it would be forced into a “hands off” non-involvement role, and that it would voluntarily disband its previous “command and control” authority.  

If we believe that FSIS can be held true to these promises, the agency has intentionally eviscerated itself of any meaningful authority in the industry. So, will the agency comply with all its promises, or be noncompliant?  FSIS must publicly decide: is its primary goal to promote agency comfort with the large plants, or to promote and protect public health?  

Many articles have been written this century about the agency’s cozy “revolving door” relationship with the big packers and their national associations. While the two partners continue to share employees, we can’t accuse them of illegal associations, but the conflict of interest is obvious.  

Poking holes in FSIS-style HACCP is easy, as agency misdeeds and inaction have provided us limitless fodder.  More difficult however is clearly defined changes the should be implemented to promote public health concerns.  Part 9 will provide numerous suggestions for long overdue changes.

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John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

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