U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF INSPECTOR GENERAL

Public May Be Making 

Indoor Mold Cleanup Decisions 

Based on EPA Tool Developed 

Only for Research Applications 

Report No. 13-P-0356 August 22, 2013 

Scan this mobile 

code to learn more 

about the EPA OIG. 
 

 

Report Contributors: Rick Beusse 

 Bao Chuong 

 Jim Hatfield 

Abbreviations 

CRADA Cooperative Research and Development Agreement 

EPA U.S. Environmental Protection Agency 

ERMI Environmental Relative Moldiness Index 

FY Fiscal Year 

HUD U.S. Department of Housing and Urban Development 

MSQPCR Mold Specific Quantitative Polymerase Chain Reaction 

OIG Office of Inspector General 

ORD Office of Research and Development 

Cover photo: Extensive mold contamination of ceiling and walls. (EPA photo) 

Hotline 

To report fraud, waste, or abuse, contact us through one of the following methods: 

email: OIG_Hotline@epa.gov write: EPA Inspector General Hotline 

phone: 

fax: 

1-888-546-8740 

202-566-2599 

1200 Pennsylvania Avenue, NW 

Mailcode 2431T 

online: http://www.epa.gov/oig/hotline.htm Washington, DC 20460 
 

 

 

U.S. Environmental Protection Agency 13-P-0356 

August 22, 2013 Office of Inspector General 

At a Glance
 

Why We Did This Review 

An Office of Inspector General 

hotline complaint alleged that 

firms were using the 

U.S. Environmental Protection 

Agency-developed 

Environmental Relative 

Moldiness Index tool to 

evaluate homes for indoor mold 

even though the EPA had not 

validated the tool for public use. 

The EPA developed ERMI as a 

way to objectively describe the 

mold burden present in a 

home. The index is based on a 

national sample of indoor mold 

values. These mold values 

were determined using an 

EPA-patented technology 

called mold specific quantitative 

polymerase chain reaction. 

MSQPCR is a way to identify 

and quantify indoor mold 

species. As of January 2013, 

the EPA had 10 active licenses 

of the MSQPCR technology. 

We sought to determine 

whether MSQPCR and ERMI 

had been properly peer 

reviewed and validated for 

public use. 

This report addresses the 

following EPA Goal or 

Cross-Cutting Strategy: 

 Advancing science, 

research, and technological 

innovation. 

For further information, contact 

our Office of Congressional and 

Public Affairs at (202) 566-2391. 

The full report is at: 

www.epa.gov/oig/reports/2013/ 

20130822-13-P-0356.pdf 

Public May Be Making Indoor Mold Cleanup Decisions 

Based on EPA Tool Developed Only for Research Applications 

What We Found 

We substantiated the allegation that firms were using the mold index tool 

although the EPA had not validated the tool for public use. The EPA readily 

acknowledged that it had not validated or peer reviewed MSQPCR or ERMI for 

public use. The agency said it considers MSQPCR and ERMI to be research 

tools not intended for public use. Although the EPA has licensed MSQPCR to 

companies for introduction into the marketplace under the Federal Technology 

Transfer Act of 1986, neither federal law nor the EPA’s procedures address the 

level of validation needed before or after transferring federally developed 

technologies to the private sector. In addition, there are no EPA regulatory 

requirements for developing or validating indoor mold test methods or assessing 

indoor mold levels. 

Licensees were marketing MSQPCR to the public as part of the ERMI tool. In our 

view, one current and one past licensee’s advertising could mislead the public 

into thinking that these research tools are EPA-approved methods for evaluating 

indoor mold. The license agreements stipulate that the licensee should not state 

or imply in any medium that the EPA endorses MSQPCR. In addition, information 

that appeared on an EPA webpage suggested that the EPA validated and 

endorsed MSQPCR for public use. Consequently, there is a risk that the public 

may make inappropriate decisions regarding indoor mold on the belief that 

MSQPCR and ERMI results were based on research tools fully validated and 

endorsed by the EPA for public use. Public awareness of indoor mold has risen 

over the past several years, and trade industry and other publications have 

raised concerns about the legitimacy of some firms offering remediation services. 

Because of the numerous questions the EPA received from the public regarding 

the ERMI tool, the EPA drafted a fact sheet on indoor mold, MSQPCR, and 

ERMI. Informing the public about the ERMI tool and monitoring compliance with 

license agreements would improve assurance that the public is not misled about 

the ERMI tool and understands its limitations. However, the EPA has not finalized 

or published this fact sheet. 

 Recommendations and Planned Corrective Actions 

We recommend that the EPA periodically review licensee advertising of the 

MSQPCR tool to determine whether licensees have violated the terms of the 

license agreement and take appropriate actions as necessary. We also 

recommend that the EPA remove or clarify potentially misleading statements on 

its webpage, and finalize a fact sheet on indoor mold, MSQPCR and ERMI to 

inform the public that MSQPCR and ERMI have not been peer reviewed or 

validated for public use. The agency generally agreed with our report and 

provided corrective actions and estimated completion dates that meet the intent 

of our recommendations. Also, the agency has removed a webpage containing 

potentially misleading statements; thus, we are closing this recommendation. 
 

 Lek Kadeli, Principal Deputy Assistant Administrator 

 Office of Research and Development 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

THE INSPECTOR GENERAL 

August 22, 2013 

MEMORANDUM 

SUBJECT: Public May Be Making Indoor Mold Cleanup Decisions Based on EPA Tool 

Developed Only for Research Applications 

 Report No. 13-P-0356 

FROM: Arthur A. Elkins Jr. 

TO: 

This is our report on the subject evaluation conducted by the Office of Inspector General of the 

U.S. Environmental Protection Agency. This report describes issues the OIG identified and makes 

recommendations to address these issues. The report represents the opinion of the OIG and does not 

necessarily represent the final EPA position. Final determinations on matters in this report will be 

made by EPA managers in accordance with established audit resolution procedures. 

Action Required 

You are not required to provide a written response to this final report because you agreed to all 

recommendations and provided corrective actions and planned completion dates that meet the intent 

of our recommendations. Recommendations 1 and 3 remain open with corrective actions ongoing. 

Please update the EPA’s Management Audit Tracking System as you complete the planned 

corrective actions for recommendations 1 and 3. Since the Office of Research and Development 

already completed actions that meet the intent of recommendation 2, we are closing that 

recommendation. Please notify my staff if there is a significant change in the agreed-to corrective 

actions. We will post this report on our website at http://www.epa.gov/oig. 

If you or your staff have any questions regarding this report, please contact Assistant Inspector 

General for Program Evaluation Carolyn Copper at (202) 566-0829 or copper.carolyn@epa.gov, 

or Director for Air Evaluations Rick Beusse at (919) 541-5747 or beusse.rick@epa.gov. 
 

 

 

 

Public May Be Making Indoor Mold Cleanup Decisions 13-P-0356 

Based on EPA Tool Developed Only for Research Applications 

Table of Contents 

Purpose........................................................................................................................ 1
 

Background ................................................................................................................. 1
 

The EPA’s Efforts to Address Indoor Mold ........................................................... 1 

The EPA’s Development and Transfer of the MSQPCR Technology .................. 2 

The EPA’s Development of ERMI ........................................................................ 2 

Scope and Methodology............................................................................................. 3
 

Results of Review ....................................................................................................... 4
 

MSQPCR and ERMI Are Research Tools That Have Not Been 

Validated or Peer Reviewed for Public Use ................................................... 4 

Licensee Advertising Could Mislead the Public Into Thinking That 

An EPA Office of Science Policy Webpage Suggested That the EPA 

Risk That the Public May Make Inappropriate Decisions on Belief That 

MSQPCR and ERMI Results Are Based on the EPA’s Validated and 

MSQPCR is an EPA-Approved Test Method for Evaluating Indoor Mold ...... 5 

Had Validated and Endorsed MSQPCR for Public Use ................................. 6 

Endorsed Research Tools .............................................................................. 6 

Conclusions................................................................................................................. 7
 

Recommendations...................................................................................................... 7
 

Agency Comments and OIG Evaluation ................................................................... 8
 

Status of Recommendations and Potential Monetary Benefits.............................. 9
 

Appendices 

A Agency Comments on Draft Report .................................................................... 10
 

B Distribution ............................................................................................................ 13
 
 

 

 

 

 

Purpose 

The Office of Inspector General received a hotline complaint that alleged firms 

were using the U.S. Environmental Protection Agency-developed Environmental 

Relative Moldiness Index® tool to evaluate homes for indoor mold even though 

the EPA had not validated the tool for public use. We sought to determine 

whether the EPA’s ERMI tool1

 had been properly peer reviewed and validated for 

public use. 

Background 

According to the EPA, the presence of molds in indoor environments is a growing 

concern in the United States, but there is no practical way to eliminate all molds 

and mold spores in the indoor environment. The way to control indoor mold 

growth is to control moisture, according to the EPA. Eliminating mold growth can 

prevent damage to building materials and furnishings and prevent health effects 

and symptoms associated with exposure to mold. Specific reactions to mold 

exposure can include: 

 Allergic reactions.
 

 Asthma.
 

 Hypersensitivity pneumonitis.
 

 Irritant effects.
 

 Opportunistic infections. 

The EPA’s Efforts to Address Indoor Mold 

One of the EPA’s indoor air quality priorities is to reduce exposure to asthma 

triggers such as mold. The EPA’s Office of Radiation and Indoor Air addresses 

indoor mold concerns by various means, including educating the public on the 

health risks associated with mold exposure and how to reduce mold exposure, 

creating partnerships with public and private sector entities to encourage the 

public to minimize their risk and mitigate indoor mold problems, coordinating and 

collaborating with other federal agencies, and conducting research. 

The EPA’s Office of Research and Development’s National Exposure Research 

Laboratory conducts research to develop the knowledge and tools necessary to 

assess potential exposures and risks to emerging environmental threats, and 

mitigate exposures to known contaminants and environmental stressors. This 

includes developing detection methods for microbial pathogens and assessment 

tools. The mold specific quantitative polymerase chain reaction technology and 

ERMI are products of the National Exposure Research Laboratory’s research. 

1

 In this context, the ERMI tool refers to the process of collecting samples in accordance with the ERMI protocol, 

analyzing the samples using the MQSPCR and calculating a score using the ERMI algorithm. 

13-P-0356 1 
 

 

 

 

 

Currently, the EPA does not have any regulations or standards for airborne mold 

contaminants. Further, there are no regulatory requirements for test methods used 

to quantify mold levels, such as those that exist for regulated pollutants and 

contaminants. There are also no federal requirements for remediation of indoor 

mold. 

The EPA’s Development and Transfer of the MSQPCR Technology 

To understand the significance of mold exposure, a standardized technology was 

needed for the identification and quantification of mold species. To address this 

need, the EPA developed MSQPCR, a DNA-based method of mold analysis. 

MSQPCR can identify and quantify over 100 species of mold. The U.S. Patent and 

Trademark Office granted the EPA a patent for MSQPCR in May 2002. The two 

EPA scientists identified on the patent as the inventors assigned their patent rights 

to the EPA. 

Under the Federal Technology Transfer Act of 1986, the EPA has licensed 

MSQPCR to 21 companies since August 2000. The primary purpose of federal 

technology transfer is to aid the U.S. economy by making U.S. products more 

competitive in world markets. The concept is for federal labs to get the ideas, 

inventions and technologies developed with taxpayer dollars into the hands of the 

private sector as quickly as possible in a form useful to that community. Federal 

labs must support activities to enhance the awareness, adoption and use of their 

technology products. Federal law does not specify validation requirements for 

technology transfer.2 

Of the 21 companies licensed to use MSQPCR, 10 had active licenses as of 

January 2013. License agreements were typically valid for 3 to 12 years and may 

be renewed for successive periods up to 5 years. Two of the 10 active licenses had 

been renewed for at least one 5-year period. 

Nine of the 10 companies with active licenses planned to market the technology 

to various industry sectors, including indoor air quality, environmental laboratory 

and real estate (e.g., homeowners, commercial building owners). MSQPCR has 

been applied to assess indoor air and indoor surfaces for molds, such as pre- and 

post-remediation testing, to show adequate cleaning of problematic mold species. 

According to the EPA, from fiscal years 2009 through 2012, the EPA’s National 

Exposure Research Laboratory and the EPA inventors of the MSQPCR 

technology received over $336,000 in royalties from the licensees. 

The EPA’s Development of ERMI 

Although MSQPCR provides a method for identifying and quantifying fungi 

mold, there had been a lack of a standardized method for describing the mold 

2 Federal law on technologies developed with federal funds is outlined in 15 U.S.C. §§ 3701-22. 

13-P-0356 2 
 

 

 

burden in a home. In 2007, EPA and U.S. Department of Housing and Urban 

Development researchers developed ERMI as a way to objectively describe the 

mold burden present in a home. These researchers determined that 36 mold 

species were sufficient to describe the mold burden of a home. As part of the 

HUD-sponsored 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. The ERMI values were then calculated for each of the 

1,096 homes. The values were assembled from lowest to highest and divided into 

quartiles. The values ranged from -10 to 20. 

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 (i.e., lowest 25 percent, highest 

25 percent, etc.). According to the EPA, as of January 2013, researchers have 

applied ERMI in childhood asthma studies in cities across the United States, 

including Cincinnati, Chapel Hill, Detroit, Boston, Kansas City and San Diego. 

The studies found higher ERMI values in homes of asthmatic children compared 

to controls. 

Scope and Methodology 

We conducted our review from December 2012 to June 2013 in accordance 

with generally accepted government auditing standards. Those standards 

require that we plan and perform our review to obtain sufficient, appropriate 

evidence to provide a reasonable basis for our findings and conclusions based 

on our objectives. We believe that the evidence obtained provides a reasonable 

basis for our findings and conclusions based on our objectives. 

To accomplish our objective, we interviewed the complainant, as well as ORD, 

Office of General Counsel, and Office of Radiation and Indoor Air staff; and 

managers in Washington, D.C.; Research Triangle Park, North Carolina; 

Cincinnati, Ohio; and Denver, Colorado. We also reviewed documents provided 

by the complainant and ORD, as well as information we gathered from Internet 

searches. We reviewed the license agreements and associated documents for all 

10 active licensees and one former licensee. These documents included 

development and marketing plans, and cooperative research and development 

agreements. We reviewed the websites of the EPA and current and former 

licensees for information on MSQPCR, ERMI and indoor mold. We reviewed an 

ORD-requested external peer review of MSQPCR and ERMI, and EPA articles on 

the development of MSQPCR and ERMI that were published in peer-reviewed 

journals. We also obtained information on the amount of royalties the EPA and 

the EPA researchers received between FYs 2009 and 2012. 

13-P-0356 3 
 

 

Results of Review 

The EPA readily acknowledged that MSQPCR and ERMI have not been validated 

or peer reviewed by EPA for public use. The agency considers MSQPCR and 

ERMI to be research tools not intended for public use. However, the manner in 

which one active and one inactive licensee advertised MSQPCR and ERMI has 

the potential to mislead the public into thinking that these research tools are 

EPA-approved methods for evaluating indoor mold. Also, information appearing 

on an EPA Office of Science Policy webpage suggests that the EPA has validated 

and endorsed MSQPCR for public use. The EPA has developed but has not 

finalized a fact sheet on MSQPCR, ERMI and indoor mold for the public. 

Consequently, there is a risk that the public may make inappropriate decisions or 

take unnecessary actions regarding indoor mold on the belief that MSQPCR and 

ERMI results were based on research tools fully validated and endorsed by the 

EPA for public use. 

MSQPCR and ERMI Are Research Tools That Have Not Been 

Validated or Peer Reviewed for Public Use 

The EPA managers stated that both MSQPCR and ERMI are research tools that 

have not been validated or peer reviewed by the EPA for public use. However, the 

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. According to the agreements, this would serve the 

public interest by providing improved products and processes for identifying and 

quantifying mold. Further, the licensee development and marketing plans 

explained how the licensees would commercialize MSQPCR. One licensee, in its 

application, described the potential to use ERMI to determine whether a house is 

normal or abnormal with respect to moldiness. 

Based on EPA’s guidance, if the EPA were to publish MSQPCR as an EPA 

approved method, a multi-lab validation study would be conducted to ensure that 

labs could obtain consistent results using the MSQPCR technology. However, 

none of the licensee development and marketing plans we reviewed included a 

plan to participate in a multi-lab validation study. Since the EPA does not regulate 

indoor mold, there are no regulatory requirements regarding the development of 

indoor mold quantification technology or its use. 

Although MSQPCR and ERMI had not been validated or peer reviewed for public 

use by the EPA, the development of these tools was published in peer-reviewed 

journals. Also, numerous studies based on using these tools were published in 

peer-reviewed journals. Further, in February 2010, the EPA conducted an external 

peer review of the science behind MSQPCR and ERMI. 

13-P-0356 4 
 

 

According to the EPA, the external peer review: 

 Concluded that the MSQPCR technology was an advancement in mold 

characterization. 

 Provided several areas for further improvement, particularly sampling. 

 Supported the ERMI approach as a research tool for assessing the 

relationship between mold growth from water damage and health impacts. 

This external peer review did not address the readiness of MSQPCR and ERMI 

for public use. 

Licensee Advertising Could Mislead the Public Into Thinking That 

MSQPCR is an EPA-Approved Test Method for Evaluating Indoor Mold 

Statements on the websites of a current licensee and a former licensee could be 

interpreted to suggest that MSQPCR was an EPA-approved method for evaluating 

indoor mold levels. The license agreements prohibit licensees from making any 

claims that EPA endorses the licensed technology, and violation of the terms of 

the license agreement could result in termination of the license. All license 

agreements stipulate the following: 

 The license agreement does not constitute an endorsement of MSQPCR by 

the EPA. 

 The licensee should not state or imply in any medium that such 

endorsement exists as a result of the license agreement. 

However, at the time we concluded our review in May 2013, one active licensee’s 

website stated that “the science and technology [of MSQPCR and ERMI] is 

backed by the EPA.” Further, the website of an inactive licensee, whose license 

expired nearly 3 years ago, included the following statement: 

The United States Environmental Protection Agency (USEPA) 

developed a standard for indoor mold analysis called ERMI .... 

Due to the establishment of a standard, this new test makes 

obsolete all previous tests used to identify potential mold related 

issues, including traditional microscopic analysis of spore traps, 

tape lifts, and swabs. [Company name] is one of 16 labs worldwide 

to be licensed by the EPA to perform ERMI analysis. 

In our view, these statements suggest endorsement by the EPA, which would 

violate the terms of the agreement. The above statements suggested that ERMI, 

along with MSQPCR, had been validated and that the EPA endorsed these tools 

for public use. In particular, referring to ERMI as an EPA-developed standard is 

misleading as the general public may interpret the term standard as applied to the 

EPA to refer to establishment through the regulatory process. 

13-P-0356 5 
 

 

Federal technology transfer staff at the EPA stated that they do not have a 

program to monitor licensees’ compliance with the current terms of the license 

agreements. We have informed the agency of the misleading advertising by the 

active and inactive licensees so that they may take appropriate actions. 

Additionally, we found instances where firms that were not issued MSQPCR 

licenses by EPA either stated or suggested on their websites that ERMI is an 

EPA-approved method for mold analysis. In one instance, a firm’s website 

included the EPA’s logo in advertising its services for ERMI analysis. The use of 

the EPA logo is prohibited for commercial purposes such as the promotion of a 

product or service. Unauthorized use would suggest government approval of the 

privately provided product or service. 

An EPA Office of Science Policy Webpage Suggested That the EPA 

Had Validated and Endorsed MSQPCR for Public Use 

As of May 2013, an EPA Office of Science Policy webpage contained statements 

suggesting that the EPA had validated and endorsed MSQPCR for public use. The 

webpage contained the following statement: 

Anyone, anywhere, if the technique [MSQPCR] is used properly, 

should get the same identification and quantification for the target 

mold as anyone else. 

Further, a list of the MSQPCR applications on the website included the following 

language: 

Determining if an environment is abnormally mold contaminated; 

testing homes for potentially pathogenic molds . . . 

In our view, these statements suggest that MSQPCR has been validated and 

endorsed by the EPA for public use. 

Risk That the Public May Make Inappropriate Decisions on 

Belief That MSQPCR and ERMI Results Are Based on the EPA’s 

Validated and Endorsed Research Tools 

There is a risk that the public may make inappropriate decisions or take 

unnecessary actions regarding indoor mold due to their belief that their mold tests 

were based on research tools that are fully validated and endorsed by the EPA for 

public use. Because MSQPCR and ERMI have not been validated and peer 

reviewed for public use, the work necessary to assure that mold test results are 

accurate has not been done. 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. 

13-P-0356 6 
 

 

If mold samples are not collected in accordance with the sampling procedures 

used to develop the ERMI, the results would be of questionable value. At least 

five of the 10 companies with active MSQPCR licenses offered to test homes for 

the 36 indicator mold species using MSQPCR and then calculate an ERMI value 

for the client. We found one instance where a licensed company produced an 

ERMI value for a commercial building even though the ERMI values are based 

on testing of residential homes. Consequently, homeowners and building owners 

are at risk of spending tens of thousands of dollars to remediate their homes or 

buildings based on test results that may or may not be accurate. Further, other 

homeowners and building owners may not take needed remedial actions to 

address indoor mold risks based on the test results. 

Given the increased public awareness of indoor mold and, according to an EPA 

manager in the Office of Radiation and Indoor Air, an increase in the number of 

indoor mold remediation firms, it is important that the public is aware of the 

strengths and limitations of the ERMI tool. EPA has received questions from the 

public regarding ERMI, including the interpretation of ERMI values. In some 

instances, people contacting the EPA asked for the EPA’s recommendations on 

which labs to use in obtaining ERMI evaluations. To ensure consistency in the 

agency’s response to such questions, the EPA has developed, but not finalized, 

a fact sheet for the public on indoor mold, MSQPCR, and ERMI. 

Conclusions 

The EPA readily acknowledged that it had not validated MSQPCR or ERMI for 

public use. However, public use of these tools has resulted from the transfer of the 

MSQPCR technology to licensees. Public inquiries received by EPA staff suggest 

that there is a risk the public may make inappropriate decisions regarding indoor 

mold based on the belief that the ERMI tool has been fully validated by the EPA 

for public use. Information that has appeared on the EPA’s webpage and on those 

of some of the licensees, as well as the fact that EPA has licensed the use of the 

technology, could have contributed to this misconception. Based on public 

concerns about indoor mold and its possible health impacts, there is the potential 

for firms or individuals to overstate the implications of the ERMI tool results to 

clients in order to persuade them to undertake more costly remediation services. 

In our view, the EPA has an obligation to inform the public on the limitations of 

this tool and explain the EPA’s position on its use for assessing indoor mold 

concerns. 

Recommendations 

We recommend that the assistant administrator for the Office of Research and 

Development: 

1.	 Periodically review licensee advertising to determine whether licensees 

have violated the terms of their agreement by implying the EPA’s 

endorsement of MSQPCR and take appropriate action based on the results 

of this review. 

13-P-0356 7 
 

 

2.	 Remove or clarify statements on the EPA’s website that imply or suggest 

the EPA validated or endorsed MSQPCR for public use. 

3.	 Finalize the fact sheet on indoor mold, MSQPCR and ERMI to include 

discussion on the limitations of these tools and make it available to the 

public, including posting the fact sheet on the EPA’s website. 

Agency Comments and OIG Evaluation 

ORD generally agreed with our recommendations and provided a corrective 

action plan with milestone dates to address recommendations 1 and 3. ORD’s 

proposed corrective actions and planned completion dates for recommendations 1 

and 3 meet the intent of our recommendations. These recommendations will 

remain open pending completion of the proposed corrective actions. 

For recommendation 2, ORD removed the webpage in question. Therefore, we are 

closing recommendation 2. 

No further EPA response to this report is required. Appendix A contains the 

agency’s response to our draft report, including its planned actions for each 

recommendation. 

13-P-0356 8 
 

 

 

 

 

 

Status of Recommendations and 

Potential Monetary Benefits 

POTENTIAL MONETARY 

RECOMMENDATIONS BENEFITS (in $000s) 

Rec. 

No. 

Page 

No. Subject Status1 Action Official 

Planned 

Completion 

Date 

Claimed 

Amount 

Agreed-To 

Amount 

1 7 Periodically review licensee advertising to 

determine whether licensees have violated the 

terms of their agreement by implying the EPA’s 

endorsement of MSQPCR and take appropriate 

action based on the results of this review. 

O Assistant Administrator for 

Research and Development 

9/30/14 

2 

3 

8 

8 

Remove or clarify statements on the EPA’s website 

that imply or suggest the EPA validated or 

endorsed MSQPCR for public use. 

Finalize the fact sheet on indoor mold, MSQPCR 

and ERMI to include discussion on the limitations 

of these tools and make it available to the public, 

including posting the fact sheet on the EPA’s 

website. 

C 

O 

Assistant Administrator for 

Research and Development 

Assistant Administrator for 

Research and Development 

7/26/13 

11/22/13 

O = recommendation is open with agreed-to corrective actions pending 

C = recommendation is closed with all agreed-to actions completed 

U = recommendation is unresolved with resolution efforts in progress 

13-P-0356 9 

1 
 

 

 

 

 

 

 

 

Appendix A 

Agency Comments on Draft Report 

July 26, 2013 

MEMORANDUM 

SUBJECT: Response to the Office of Inspector General Draft Report, Results of Hotline 

Complaint Review of the EPA’s Tool of Evaluating Indoor Mold, Project No. OPEFY13-0007, June 12, 2013 

FROM: Lek G. Kadeli, Principal Deputy Assistant Administrator 

TO: Arthur A. Elkins, Jr., Inspector General 

Office of Inspector General (OIG) 

Thank you for the opportunity to respond to the OIG draft report titled, Results of Hotline 

Complaint Review of the EPA's Tool for Evaluating Indoor Mold. The Environmental Protection 

Agency (EPA) is committed to protecting the public health and appreciates the OIG's efforts to 

ensure that the public does not make potentially inappropriate decisions regarding indoor mold. 

The Agency generally agrees with the OIG's recommendations and can improve monitoring 

efforts to ensure licensees' compliance with terms of license agreements under the Federal 

Technology Transfer Act (FTTA). However, we believe that the decision to license the 

technology in question was proper and in full accordance with the intent of the FTTA. In 

response to both public and the OIG's inqui ry, the EPA's Office of Research and Development 

(ORD) has acknowledged that an indexing tool (ERMI) and patented method for characterizing 

mold (MSQPCR), licensed to private companies, had been properly peer reviewed but not 

validated for uses other than research. 

The MSQPCR patent was licensed in accordance with the Patent Act, 35 U.S.C. § 207, and the 

FTTA, 15 U.S.C. § 3710a. Congress enacted the FTTA in 1986 to promote the speedy and 

efficient transfer of the fruits of federal laboratory research into the market place1

 and delegated 

decision-making authority to laboratory directors expressly to bypass some of the impediments 

common in other types of agency programs.2 

It appears that the hotline complaint is based on the assumption that the patented method and 

indexing tool should have been validated for routine public use before EPA/ORO licensed the 

technology. Federal law does not specify validation requirements for technology transfer. 

Licensing the MSQPCR patent (already found “new and useful” after the rigors of the patent 

1

 For example, see: S. Rep. No. 99-283, at 1, “The purpose of this bill is to improve the transfer of commercially 

useful technologies from the federal laboratories and into the private sector.” 2

 For example, see: S. Rep. No. 99-283, at 4, “A requirement to go to agency headquarters for approval of
 

collaborative arrangements and patent licensing agreements can effectively prevent them.” 

13-P-0356 10 
 

 

 

 

application process) and the use of the ERMI tool allows the technology to be assessed and 

potentially improved by its actual, real-world application. 

In addition, federal agency technology transfer programs operate differently from more familiar 

agency programs, like rule-making, permitting and product and labeling approvals. In these 

programs, agencies gather information (often through validation and peer review processes), 

identify and debate options at length, and then establish enforceable standards that manufacturers 

and others must meet. In technology transfer programs, the EPA and other agencies look to the 

private sector to improve, test, use or even reject technology produced in federal laboratories. 

In conclusion, we thank you again for the opportunity to provide our comments to the OIG's 

report. The EPA's responses to the OIG's recommendations are provided below. 

AGENCY RESPONSE TO REPORT RECOMMENDATIONS 

No. Recommendation Corrective Action (s) Estimated 

Completion 

Date 

1 Periodically review 

licensee advertising to 

determine whether licensees 

have violated the terms of 

their agreement by implying 

the EPA's endorsement of 

MSQPCR and take 

appropriate action based on 

ORD/OARS Federal Technology 

Transfer Act (FTTA) staff has started 

the process of reviewing websites of all 

active MSQPCR licensees to look for 

language that suggests endorsement or 

validation by EPA. FTTA staff will 

work with OGC to address any such 

issues with licensees. 

9/30/2013 

the results of this review. The FTTA staff will institute a more 

comprehensive, annual review of all 

First annual 

review 

active FTTA licensees to look for will be 

language that suggests endorsement or completed by 

validation by EPA. FTTA staff will the end of 

work with OGC to address any such FY14 

issues with licensees. 

2 Remove or clarify statements 

on the EPA's website that 

imply or suggest the EPA 

validated or endorsed 

MSQPCR for public use. 

ORD has removed the website. Complete 

3 Finalize the fact sheet on 

indoor mold, MSQPCR and 

ERMI to include discussion 

on the limitations of these 

tools and make it available to 

the public, including posting 

the fact sheet on the EPA's 

website. 

ORD/NERL will finalize the fact sheet 

and make it available by posting on an 

EPA website and providing it to the 

public when questions arise about the 

technology. 

To be 

completed 

within three 

months of the 

issuance of 

OIG's final 

report 

13-P-0356 11 
 

 

 

 

Should you or your staff have any questions, please contact Deborah Heckman at (202) 564­

7274. 

cc: Ramona Trovato 

Bob Kavlock 

 Alice Sabatini 

 Jennifer Orme-Zavaleta 

 Fred Hauchman 

13-P-0356 12 
 

 

Appendix B 

Distribution 

Office of the Administrator 

Principal Deputy Assistant Administrator for Research and Development 

Agency Follow-Up Official (the CFO) 

Agency Follow-Up Coordinator 

General Counsel 

Associate Administrator for Congressional and Intergovernmental Relations 

Associate Administrator for External Affairs and Environmental Education 

Associate Assistant Administrator, Office of Research and Development 

Deputy Assistant Administrator for Science, Office of Research and Development 

Director, Office of Administrative and Research Support, Office of Research and Development 

Director, National Exposure Research Laboratory, Office of Research and Development 

Director, Office of Science Policy, Office of Research and Development 

Audit Follow-Up Coordinator, Office of Research and Development 

13-P-0356 13