#• o %
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.

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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:	1-888-546-8740	1200 Pennsylvania Avenue, NW
fax:	202-566-2599	Mailcode 2431T
online:	http://www.epa.gov/oiq/hotline.htm	Washington, DC 20460

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

i	\ Office of Inspector General	August 22,2013
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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.aov/oia/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.

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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
T?	1 "a	^ f\
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.
FROM:
Arthur A. Elkins Jr.
TO:
Lek Kadeli, Principal Deputy Assistant Administrator
Office of Research and Development

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Public May Be Making Indoor Mold Cleanup Decisions
Based on EPA Tool Developed Only for Research Applications
13-P-0356
Table of C
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
MSQPCR is an EPA-Approved Test Method for Evaluating Indoor Mold		5
An EPA Office of Science Policy Webpage Suggested That the EPA
Had Validated and Endorsed MSQPCR for Public Use		6
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		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
B Distribution	
10
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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 Indexฎ 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.
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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. งง 3701-22.
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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.
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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.
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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.
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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.
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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.
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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.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec.
No.
Page
No.
Subject
Status1
Action Official
Planned
Completion
Date
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.
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.
Claimed
Amount
Ag reed-To
Amount
Assistant Administrator for 9/30/14
Research and Development
Assistant Administrator for 7/26/13
Research and Development
Assistant Administrator for 11/22/13
Research and Development
1 0 = 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
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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. OPE-
FY13-0007, 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 inquiry, 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. ง 207, and the
FTTA, 15 U.S.C. ง 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 I, "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."
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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
the results of this review.
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 FTTA staff will institute a more
comprehensive, annual review of all
active FTTA 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.
First annual
review
will be
completed by
the end of
FY 14
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
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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
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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
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