As I See It- EPA’s Office of Inspector General (OIG) suddenly claims the agency’s intellectual property, a published, patented and licensed product, ERMI, has not been validated for public use
By Ritchie Shoemaker, M.D.
Scott McMahon, MD
At least two things are true about government agencies. First, they never do anything quickly. Second, if there is an issue that they want to use to make their scientific stance appear accountable to the American public, they’ll do so by highlighting their response to a complaint, often acknowledging error in public documents. Responses to complaints, however, are prime areas for agencies to install political spin on important issues. Read what they say looking for double talk! We can almost guarantee that embedded in the error acknowledgement is usually another dig that supports a political opinion rather than a scientific one. The EPA’s shifting opinions on DNA testing for molds in wet buildings is a great example.
Each Cabinet level government agency has an Office of Inspector General, an office funded independently from cash allotted to agencies themselves by Congress. OIGs are designed to root out fraud, increase efficiency, get the bad guys ripping off the agency and provide cost control. Basically, it looks to us like the OIG is essentially a Department of Internal Affairs, an internal police force if you will. For the OIG of the EPA (www.epa.gov/oig/about.html, accessed 3/5/2104), its goals include: “Contribute to improved human health, safety and the environment.”
The Inspector General for EPA is Arthur Elkins, Jr, an attorney from Ohio appointed by President Obama in 2010. He has no evidence of experience with any issues on WDB or litigation involving human health effects from exposure to interior environments in WDB based on what we could find.
Yet his opinion about testing in WDB is one that we find dangerously off base about human health and safety of buildings. When agencies change their public stances, especially when it is CDC or EPA, we feel that something hidden, likely political, is happening. Given the number of issues some US Senators are expressing about Mr. Elkins, maybe it is time for some bright sunshine to come to bear on the ERMI issue.
Perhaps Senator Vitter (R, La) will pick up on our criticism of the EPA OIG statement on ERMI as he has (in particular) lambasted the EPA OIG for desultory procedures, practices and susceptibility to political pressure regarding actions by EPA Region 6 taken against a natural gas company (Range Resources) and the odd case of fake spy, John Beale. Senator Vitter, on February 18, 2014 in fact reported that EPA “had failed Congress in recent investigations.” And… “I can only suspect that the office has abandoned its pledge to minimize waste, fraud and abuse at the EPA.”
OIG has defended its actions but it seems to me that politics isn’t an arena suitable for answering questions of logic and integrity. So can we leave politics out of this discussion? No way. The problem with EPA and ERMI affects all of us, local or not.
The ERMI case is possibly worse even than fracking and spying concerns as over 50% of US buildings are adversely affected by water intrusion and microbial growth (NIOSH, 2011). For all the ongoing cover-up of the magnitude of the public health disaster that is the crux of this essay, we are talking about 150 million people at risk. The problem isn’t just Hurricane Katrina cover-up in New Orleans or Hurricane Sandy cover-up in the North East: it is just plain cover-up everywhere.
Beginning in 2004, EPA’s Microbial Exposure Research lab in Cincinnati, run by Dr. Steve Vesper, has brought fantastic advances to clinicians to help understand why “sick buildings” make people sick. Basically, the EPA research group proved that buildings with water damage (WDB) host entirely different ecosystems compared to non-wet buildings. WDB have a stereotypical ecosystem that thrives with elevated humidity, temperatures without much variation from 62-78� year round, and one that is out of the wind and out of the rain and snow. Of course, that is not what we see in great outdoors. But non-wet buildings are also out of the wind and snow. Yet the non-wet buildings have fungal communities that are just like the great outdoors. The difference in the two fungal communities is moisture.
Just like your Chia pet: adverse human health effects come when one just adds water.
Dr. Vesper’s group used fancy DNA testing (MSQPCR) to confirm the differences in fungal communities indoors but his group’s creation, the Environmental Relative Moldiness Index (ERMI), only looks at fungi. We all know that in wet buildings we will find gram negative bacteria and their metabolic products as well as actinomycetes and mycobacteria. ERMI is therefore a “unifocal” analysis. No one has ever claimed it is more than that.
So let’s look at what happened when someone (a lawyer?) allegedly complained to the Office of the Inspector General (OIG) that some people (horrors!) were using the Environmental Relative Mold Index (ERMI) to evaluate homes for indoor mold, even though the EPA hadn’t “validated the ERMI for public use.” The OIG report presents the response to the undocumented complaint, together with the official EPA response. The document is short, full of repetition and white space, so it won’t take long to review. (Click hereto view No. 13-P-0356, dated 8/22/13,or visit http://www.epa.gov/oig/reports/2013/20130822-13-P-0356.pdf )
As we go through the arguments below, we’ll keep a running total of errors that the OIG and EPA made as they attempted to attack ERMI. I found 27, noted by number in parentheses (27). There is a roster of the 27 elements at the end of this opinion. We would hope that those who disagree with us will respond to the 27 theses. Please send your comments to the www.survivingmold.com website.
It is not argued that EPA researchers who developed ERMI published their findings after internal agency peer review (1). The paper(s) were published after rigorous peer review (2). Then the EPA obtained patent(s) from the U.S. Patent Office (3). And then the EPA proceeded to license their technology for private use (4). More than $330,000 flowed to EPA because of licenses (5). In government terms, 300 grand sounds like chump change, but as a symbol of acceptance by the Feds, it’s worth millions.
Every ERMI paper put forth by EPA researchers contained similar language about EPA validation. In 2006, in the Synergist, Dr. Steve Vesper published the nuts and bolts for the lay community. The standard disclaimer at the end of the article says: “EPA…partially funded (6) and collaborated (7) in the research described here. It has been subjected to the agency’s peer review and has been approved as an EPA publication. Another 2006 paper (J Occup Environ Med (2006; 48: 852-858), has the disclaimer: “EPA…funded and collaborated in the research described here. It was subjected to the agency’s peer review and has been approved as an EPA publication.” Add to the constant agreement from EPA that this research is valid by reading the same kind of disclaimer from the Journal of Exposure Science on ERMI as a predictor of childhood illness: “EPA … funded and collaborated in the research describe here. It has been subjected to the Agency’s peer review and has been approved as an EPA publication…MSQPCR technology was patented by the US EPA (#6 387 652). Thus, EPA has a financial interest in the commercial use of this technology.”
The kind of validation that EPA provided is acceptable to all researchers and it was for EPA, too. That is, until the politics changed.
ERMI was simply a method to describe the mold burden in a home. It was not “for public use” or “not for public use.” It’s a measurement tool. The EPA took the results of this new research and used it to license use of the DNA testing, called MSQPCR, generating income from private industry and allowing the Federal research to be used by the public for public good (8). Who’d believe that selling a license to mycology labs to use ERMI wouldn’t result in the labs selling the test to the public?
The OIG report states, “EPA intended them for public domain use by transferring the technology under the Federal Technology Transfer Act. Each of the 10 active license agreements noted the EPA’s desire that the licensee make MSQPCR available to the public in the shortest possible time (8).”
So how is it again that the EPA didn’t know that the public would use ERMI? That old man politics is back playing with words and trying to change history.
Face it: Research is validated as having scientific merit or not; not for some gratuitous ad hoc appellation of “validated for public use.” Dr. Vesper’s work was simply outstanding, revolutionary in its accuracy and reproducibility, elements always missing from air sampling.
And so it was from 2006 through 2012. Then, coinciding with major mold litigation, including some involving U.S. military housing interests where ERMI plays a major role in the plaintiffs’ cases, suddenly EPA became worried that the agency hadn’t validated the test for public use. ERMI was fine for research on members of the public, using samples collected by the public, but it couldn’t possibly be safe for use by the public (9)?
Does this make logical sense? Something stinks. Don’t forget EPA’s behavior toward its workers sickened by the EPA Waterside Mall facility on M Street in Washington, D.C. (Chapter 9, Jerry Koppel, in Surviving Mold). The EPA doesn’t want to admit anything about humans being hurt by exposure to wet buildings partly because of their own egregious behavior to the human beings affected by mold in agency buildings. No wonder the OIG won’t acknowledge what made people sick in Waterside and all other wet government buildings (10).
And now the OIG and EPA as a whole agree that the EPA “had not validated the test for public use.” OK, what is the basis for that accusation? Where is the proof, the facts? If there is no validation that must mean that there is an established method used to document such validation is missing in this discussion. That makes sense, right?
Is EPA required to establish validation? Nope. Oops.
We mustn’t forget that the OIG report states on page 1 “…there are no Federal laws and no EPA procedures that address the level of validation needed before or after transferring federally developed technologies to the private sector (11).” The OIG also adds, “There are no EPA regulatory requirements for developing or validating indoor mold test methods or assessing indoor mold levels (12).”
Since 11 and 12 above are true, those regulatory realities would have ended this “public use” hysteria before it even started. Unless politics are involved.
Still, let’s think for a minute about who this powerful complainer might be, because the hysteria recently accelerated. What’s the motivation? Do they have any bias? If the complainer is a defense attorney, then the plaintiff needs to know about the complaint and the defense attorney(s) involved should be sanctioned. If the complainer isn’t real — if this is just politics — then the EPA needs to be sanctioned. Let there be sunlight.
There are credibility issues here. It’s time for a Senate investigation examining whether EPA was required to validate ERMI for public use. The OIG says EPA didn’t validate the ERMI for public use, even though there are no laws or regulations that say such validation must be done.
Why would somebody in EPA want to slam ERMI? Here’s a tool that’s been handed down by EPA itself. The decision was fine until the politics got complicated.
Of course, when ERMI came out, the public used it. Our group did the validation to show that the ERMI test of building health could be correlated with human health (13). And countless members of the public did the same. EPA didn’t need to validate the test for public use: public use validated the test! ERMI was shown to have utility by our group in 2007 (SAIIE) and again in 2008 (When SAIIE meets ERMI).
For all those youngsters who didn’t hear George Carlin bust the hypocrisy and pompousness of politicians, let us share a memory with you. George had a great routine in which he changed to word “kill” to something of another four letters. “Sheriff, I am going to ---- you but I am going to ---- you real slow” was one clip. The point was well taken. Substitute one word for another and see how the meanings of the words change.
Imagine if we hypothetically tried to understand the OIG’s unscientific attack on ERMI by putting the term “pickaxe” in its place. If EPA invented a pickaxe — a fabulous new tool — and found it useful to pierce hard surfaces and dig trenches under those hard surfaces, permitting the public to use this tool would be a great help to the working men who have struggled to dig trenches without it. And in the course of human events, some working person would look at the other spiky half of the tool, finding an implement that could cut roots. Now, it wouldn’t take long before a worker could dig a trench and he could cut any roots that might be in the way of progress in trenching. What a great tool! But then some person from the government could stop the work after a hush-hush internal review showed that the use of the other side of the pickaxe hadn’t been validated.
Here is where it gets sticky. What if the government was simply acting on the request from a pick company (“Handsomely-Picked”) that had tons of government contracts that were now in jeopardy due to the popular acclaim for the pick-axe? They needed a way to get rid of its competition, as the pickaxe iced the pick in performance of trenching in the presence of roots. Handsomely-Picked [Editor’s note: This name is made up and should not be thought to actually represent a real company] tried to discredit the pickaxe by calling it a mattock but that word was soon off limits (sounded too much like buttock). Handsomely-Picked needed to do something radical to get their contracts back, even though their product was inferior.
Given that (a) money drives politics and (b) politics drives science, we may conclude that (c) money drives science.
The EPA didn’t let anyone know their opinion was swayed by the big bosses who wanted Handsomely-Picked to appear to be better. So it was decided that the EPA would help preserve the public safety by saying to the sweaty trencherman, “No, you can’t use the tool to cut roots. All we did when we invented it was to show it helped cut trenches. It has to be validated as a root cutter.” [Editor’s note: The putative EPA guy in this image looks just like the EPA inspector in the movie Ghostbusters who shuts down the power to the ghost-trapping device.] The next scene in this fictional movie would be the EPA inspector trying to pull the root-cutting spike of the pickaxe from his chest, saying “You can’t use the tool for this. We haven’t validated use of the pickaxe to impale EPA inspectors.”
How long would the EPA be allowed to stop the pickaxe from being used in more than one way? If the EPA said we couldn’t use the pickaxe to cut roots and dig trenches in hard surfaces, but it was in the public domain, who’d care about the EPA’s opinion anyhow (14)?
Still — and this issue is critically important to credibility — we have to look at the OIG’s credentials to serve as the provider of the Supreme Opinion in this case (15). Granted, the cloak of authority hangs mightily over the Office of Internal Affairs of the EPA. What does the OIG know about mold illness? After all, the Feds must be aware of the 2008 U.S. GAO report that fully acknowledged the role of inflammation and immune activation in patients sickened by exposure to the interior environment of water-damaged buildings (WDB) (16). Indeed, one of the made-for litigation pieces used by mold defense consultants (AAAAI, 2006, now retired from active use) was singled out for criticism leveled by the GAO for failure to consider immunological aspects in cases. Further, the GAO attacked the absence of any logical cooperation among Federal agencies charged with protecting human health as a huge waste of taxpayer’s money.
And the OIG would be expected to know about chronic inflammatory response syndromes discussed by the World Health Organization in 2009 (17). But I didn’t see it. And it wasn’t referenced either. Yet, even with absurd deletions of world-accepted knowledge, there was still hope for the OIG to build credibility by actually going to the Mother Lode of fact, data and real science in the POA report of 2010 (View Here). The fact that OIG didn’t (18) adds to my disgust at their attempt to say they can pass judgment on ERMI.
Now let’s just pile on some abuse. Every aspect of the OIG opinion is untenable but I’ve saved the most abusive of all for last: OIG has no idea what the illness that ERMI helps show actually is.
Go to page 1 of the OIG report. Look at the five “specific reactions to mold exposure that can include:”
- Allergic reactions
- Hypersensitivity pneumonitis
- Irritant effects
- Opportunistic infections
That’s all they wrote. Anyone see anything missing? Anything the entire rest of the world knows to be present? Is the EPA OIG unable to read what is the physiologic basis of illnesses caused by wet buildings? Either (1) the OIG is without credibility for their lack of awareness or (2) that office is without credibility because they intentionally ignored pertinent and relevant information that did not support their opinion. This is why the OIG has no legitimate seat at the intellectual table to talk about ERMI, let alone to judge it in any way (19).
Anyone besides us think it odd that they said nothing about inflammation? Or immunological problems?
To stop the belaboring of the point that the OIG has no knowledge of immunological problems and inflammatory problems caused by the chemical stew found in the interior environment of water-damaged buildings, I’ll simply submit that the OIG opinion would be discarded in any court of reason and logic.
This idiotic idea that anyone, any agency, can continue the charade of ignoring inflammatory illness caused by exposure to the interior environment of water-damaged buildings must stop.
Now, if the EPA were trying to use the farce of a complaint —one whose source they never revealed — as a cover-up to say that no inflammatory illness exists, that wouldn’t be surprising. We can guarantee you that we’ll soon hear of the OIG documents being cited in court cases showing that inflammation isn’t listed as an illness caused by exposure to WDB by the EPA’s OIG. Therefore, it couldn’t exist. I already am seeing some Internet advertising from anti-ERMI groups pushing their bogus air sampling by saying EPA says ERMI isn’t validated.
Remember back in January of 2012, when the EPA was asking for testimony from people who had information about ERMI in the run-up to this puppet decision? They wanted ERMI expunged. The witch-hunt was underway.
One of us (RS) submitted his application materials to be included as a knowledgeable party about ERMI. Of course, they’d listen to his testimony. After all, he had human health data on over 2000 people who submitted ERMI tests. Our group had shown that HERTSMI-2 was an inexpensive and far superior way to show safety-or not- of exposure. RS quickly held his breath about having to travel to Washington D.C. in winter to testify. Still waiting. Looks like they made their decision without input from any practitioners who’ve actually ever used the ERMI test (20). Sad.
By now you could have read OIG report, published in January 2014, which included the July 2013 comments coming from EPA about the study by OIG investigation completed in May 2013. The OIG was critical of an EPA website specifically that of the Office of Science Policy, which suggested that the EPA had validated and endorsed MSQPCR for public use (21). That one was taken down fast after having been up for a long time.
The OIG appears to have concerns that the “public may make inappropriate decisions or take unnecessary actions regarding mold, due to their belief that the mold tests were based on research tools that are fully validated and endorsed by the EPA. Further, if samples from the same home were sent to two or more MSQPCR licensed labs, there is no guarantee that the homeowner would get the same test results.”
Inter-lab reproducibility remains one of the biggest challenges in any lab discipline (22). Sequential results must agree: there is no room for a culture to be positive one day and negative the next on the same specimens. Such a concern has nothing to do with the EPA. If the EPA were serious about protecting the public, they might look at the methods that different mycology labs use to produce ERMI results. We agree; some labs give results that are just pure nonsense.
As far as discrepancy between laboratories, a variety of companies have licensed the QCPR technology developed by the EPA in 2006, including the lab that we can show has the most accurate results (Mycometrics). [Editor’s note: Drs. Shoemaker and McMahon have no conflict of interest to report regarding any companies that produce ERMI]. Every company uses their ERMI license on a proprietary basis. Variables that are noted that could impact the observed relative insensitivity of one lab include extraction percentage of DNA as well as recovery rate, with reduced recovery rate being associated with perturbation of reported detection limits. Similarly, there are a variety of primers or probes used by laboratories. Some are the originals from Life Technologies and others are less expensive. Of all the Real Time PCR techniques that employ the open array, Real Time TAQ MAN is the standard in the industry. Use of other primers reduces sensitivity.
Additionally, there is variation of instrumentation use to run these QPCR assays, and concerns about calibration are ongoing.
The EPA did take the OIG’s opinion seriously; they agreed in July 2013 to develop and finalize a fact sheet for the public on indoor mold, MSQPCR and ERMI. That confession by EPA, that they needed to write up something for the public urgently, is the only apparent basis to let EPA itself off the hook for not validating the test that they never had to validate ever anyway.
To date, this fact sheet is not available (23).
What was really disappointing was the absence of any discussion on the known defects in ERMI (24). The EPA could have known about use of ERMI by auditing records of those labs that licensed the test. Then they could have sent out requests to the ordering physicians for voluntary disclosure of deidentified human health parameters to see just what ERMI actually means. They could have let me testify! Due diligence or don’t do diligence?
Does it bother anyone besides us that many of the same Feds who talk about mold issues since they knew about treatment of sick people in 2001 still are doing nothing to help affected patients (25)?
Why go to all the trouble to say no one knows what ERMI means to human health when our group gave the EPA information on 2,400 ERMI test results? And we have a thousand more too, all collated, analyzed and ready for review. The EPA has none. Nada.
Even worse, the EPA hasn’t learned why HERTSMI-2 is incredibly more sensitive than ERMI in detecting indoor fungi that really are important, such that people with prior illness can know if a building will make them sick or not. But that, in turn, would mean that EPA acknowledged that people with CIRS really do have illnesses that really are due to uncontrolled inflammation and are immunologic in origin (26). That action would run smack into the monolith of the OIG’s opinion. And right behind, Waterside Mall.
Finally, how was the ERMI developed (27)? According to the OIG’s own report (page 3), “As a part of a HUD-sponsored [editor’s note - U.S. Department of Housing and Urban Development] American Healthy Homes Survey, dust samples were collected from a nationwide random sampling of 1,096 homes and analyzed by MSQPCR for the 36 indicator species.” Why was this done? Again, from the same page, “Because ERMI was developed using a nationally representative sampling of homes, the EPA and HUD researchers believed that one could compare any newly sampled home in the United States to ERMI, and assess the home’s mold burden relative to the national sampling of 1,096 homes”. These were HUD homes being sampled with the expectation that other homes would be compared to them. How much more “public use” does it get?
Who decides these agency opinions? Is policy directed by career scientists and researchers? Nope. The mold attitudes we see in EPA, CDC and HUD are decided by elected politicians. I gather up my verbal stones and prepare to cast them in the direction of those politicians who steadfastly show they don’t really care about the health of the American public.
But they do care about their re-election and the moneymen who bankroll their re-elections. Just once I’d like to see someone run for office on the platform that EPA must document academic reason and logic in their decision-making process. Just once.
Specific lapses in judgment
- All EPA research must pass multiple layers of a rigorous review and criticism beginning with directors of each EPA lab. The next layers rise progressively in hierarchy until the agency itself stamps the research as approved. Each layer of higher rank is closer to the political sphere of influence compared to the lower ranks of scientific influence.
- Another layer of verification of good science comes from the editorial and peer review process of the journals. This gauntlet is another layer of integrity passed by Dr. Vesper’s group.
- US patents aren’t just passed out. A rigorous process is followed by a completely separate Federal agency to assure integrity, uniqueness and validity of the invention.
- Once a patent is issued to an agency, licensing is under the review of (guess what?) the OIG! The very group that has now concluded there must be validation for public use has approved licensing to private businesses who sell to the public
- Cash payments obtained through the licensing process are recorded by the OIG. If the research isn’t valid, what in the world is EPA doing taking the royalty and license cash. Isn’t that fraud?
- EPA agency required language is added to all agency approved research.
- EPA agency required language is added to all agency approved research.
- Agency science is intended to be made available to the public once it is approved by the agency.
- Sampling protocols are incredibly easy to follow. As long as a person can measure 3 feet by 6 feet and document passage of five minutes of time, vacuum samples are user friendly for the public. For every argument that says the public might not do the test right I will point to defense interests in litigation that obtained air samples with the windows open, and then opining that the fungi indoors were the same as the fungi outdoors.
- The latest gambit by the EPA in Jerry’s case is to say that my (RS) opinion supporting his claim is invalid since Dr. Shoemaker is a PhD and not an MD. This isn’t an error in logic: this is a lie. Shame on you, EPA and shame on you, OIG. Senator Vitter needs to know about this incredible abuse of agency power.
- The OIG faults EPA for not validating the ERMI in spite of the fact that OIG acknowledges that there is no law requiring such validation. Governments do not validate science, accurate science validates itself.
- The OIG acknowledges there are no EPA requirements for validating levels of indoor molds. And then OIG says there is a problem since the test isn’t validated by something that doesn’t exist? Did the EPA break any laws by not doing some fantasy land validation? Nope.
- ERMI is a building health index. No one ever said it was a human health index. The ERMI was correlated with human health parameters prospectively in multiple studies done by our group.
- Seriously, does the official EPA opinion about validation of a tool actually have influence on what a member of a free country does with that tool?
- The OIG of EPA is an attorney with no experience in assessment of indoor mold; no experience in assessment of health effects caused by exposure to damp buildings and has never participated in a mold litigation case that I could find.
- The US GAO report reviewed the importance of the immunological aspects of exposure to particulates in WDB, a fact omitted by the OIG in his assessment of human health effects. Ironically, the GAO concluded that there must be better coordination among Federal agencies about the issue of wet buildings; the OIG never even read GAO, as if he had, it would have been cited.
- The WHO report on wet buildings of 2009 has lots of references to chronic inflammatory responses seen in affected patients.
- The POA of 2010 was approved after internal review by 22 experts in indoor air quality and human health.
- Here is my concern that the EPA is hiding a message in its apology. Nowhere does it acknowledge the role of inflammatory illnesses; an entity noted by every agency and Federal publication, including the EPA in their own 2004 publication on wet buildings published with the team at University of Connecticut.
- Since EPA doesn’t diagnose or treat patients, how would they know what use of ERMI was out there without asking for testimony?
- Here is the EPA saying one can’t believe that what the EPA is saying. I agree.
- Labs have constant worries about quality control. Failures of labs that license the ERMI techniques to do the test the same way aren’t questioned. If protection of the public were the concern in this issue then tell me how some labs use unknown testing methods that they sell as real ERMIs?
- No fact sheet on ERMI in over one year? I know I said agencies are slow but this one page report could take at least 15 minutes to write up and check. And EPA used this dodge to escape punishment from the IG? And the OIG didn’t check to see that the work was done?
- Several mycologists have expressed concerns about ERM to me. Their concerns have never been addressed by the agency.
- I remain astounded that the same people saying the same illogical things about human health are still in power. We vote out incompetent incumbents sometimes: let’s get rid of the same uninformed career EPA mold administrative group.
- Continuous denial of the reality of CIRS only serves to hurt affected patients. Public health concerns are noted by the OIG yet he ignores the hundreds of thousands of affected people.
- ERMI was created by evaluating public homes for the intended use of creating a standard by which mold burdens in other public homes could be evaluated. This is “public use” and it was intended to be public use from the beginning. The subsequent government doublespeak is nothing more than a thinly veiled attempt to discredit the science to cover up certain “inconvenient truths”.