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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Catalyst for Improving the Environment
Hotline Report
Results of
Hotline Complaint Review
of EPA's Antimicrobial
Testing Program
Report No. 09-P-0152
May 27, 2009
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Report Contributors:
Stacey Bond
Ganesa Curley
Jerri Dorsey
Jeffrey Harris
Lauretta Joseph
Abbreviations:
ATP Antimicrobial Testing Program
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FY Fiscal Year
OECA Office of Enforcement and Compliance Assurance
OIG Office of Inspector General
OPP-AD Office of Pesticide Programs—Antimicrobial Division
SOP Standard Operating Procedure
Cover photo: The cloudy liquids in three of these test tubes show that bacteria have started
growing. The one tube with clear liquid contains a surface coated with penicillin;
this new method, developed by researchers at The University of Southern
Mississippi, prevents bacteria from growing in the tube. (Credit: The University
of Southern Mississippi)
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PRtf
U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
09-P-0952
May 27, 2009
Catalyst for Improving the Environment
Why We Did This Review
The Office of Inspector General
(OIG) received a Hotline
complaint that alleged that EPA
is withholding information on
product failures in the
Antimicrobial Testing Program
(ATP) from intended users.
Background
The EPA's Office of Pesticide
Programs—Antimicrobials
Division (OPP-AD) is
responsible for all regulatory
activities associated with
antimicrobial pesticides. A key
project of OPP-AD is the ATP,
the post-registration testing
program designed to evaluate the
effectiveness of EPA-registered
disinfectants. The focus of the
ATP is on disinfectants most
crucial to infection control:
sterilants, tuberculocides, and
hospital-level disinfectants.
For further information, contact
our Office of Congressional,
I Public Affairs and Management at
(202)566-2391.
To view the full report, click on the
following link:
www.epa.gov/oig/reports/2009/
20090527-09-P-0152.pdf
Results of Hotline Complaint Review
of EPA's Antimicrobial Testing Program
What We Found
We found that the allegation against EPA's ATP was unsubstantiated. The
program policies and procedures require OPP to notify the Office of
Enforcement and Compliance Assurance (OECA) and manufacturers when a
product fails testing. OPP-AD is not withholding information on product
failures from these intended users. As of February 2009, 325 of the 671 EPA
registered disinfectant products had been tested under the ATP. ATP
anticipates completing efficacy testing of all currently registered disinfectant
products by 2011.
The OPP-AD procedures specify what type of action is to be taken based on
testing results. When a product fails, OPP-AD follows its Standard Operating
Procedure (SOP) for product failures. OPP-AD decides whether a regulatory
or enforcement action should be pursued for products that fail. OECA makes
the final decision regarding any enforcement actions to be taken against
manufacturers.
The report does not contain any recommendations; however, we make several
observations regarding OPP policies and practices that could be improved.
OPP-AD could:
• provide publicly-accessible information on effective hospital
disinfectants and tuberculocidal products as it does with other
disinfectants.
• amend its SOPs to include products without a hospital disinfectant label
claim.
• develop a plan to sustain the program after testing is completed in 2011.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
INSPECTOR GENERAL
MEMORANDUM
SUBJECT:
FROM:
TO:
May 27, 2009
Results of Hotline Complaint Review of EPA' s
Antimicrobial Testing Program
Report No. 09-P-0 152
Wade T. Najjum
Assistant Inspector General
Office of Program Evaluation
Jim Jones
Acting Assistant Administrator
Office of Prevention, Pesticides, and Toxic Substances
This is our Hotline report on the subject evaluation conducted by the Office of Inspector General
(OIG) of the U.S. Environmental Protection Agency (EPA). This report contains our finding
regarding the Hotline allegation. The report does not contain any recommendations; however,
the OIG makes several observations regarding Office of Pesticide Programs policies and
practices that could be improved. The OIG's review of this Hotline complaint is completed with
the issuance of this report.
The estimated cost of this report - calculated by multiplying the project's staff days by the
applicable daily full cost billing rates in effect at the time - is $89,833
This report will be available at http://www.epa.gov/oig.
If you or your staff have any questions regarding this report, please contact me at (202) 566-0827
or najjum.wade@epa. gov; Jeffrey Harris, Director of Cross Media Issues, at 202-566-0831 or
harris.ieffrev@epa.gov; or Lauretta Joseph, Project Manager, at 212-637-3049 or
ansah.lauretta@epa.gov.
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Results of Hotline Complaint Review of 09-P-0152
EPA's Antimicrobial Testing Program
Table of Contents
Purpose 1
Background 1
Prior Reviews 2
Scope and Methodology 2
Results of Review 3
EPA Is Not Withholding Information on Product Failures from Intended Users 3
OPP-AD Could Further Improve Its Procedures 3
Conclusion 4
Agency Responses and OIG Evaluation 4
Status of Recommendations and Potential Monetary Benefits 5
Appendices
A Agency Comments and OIG Evaluation 6
B Distribution 10
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09-P-0152
Purpose
The Office of Inspector General (OIG) of the U.S. Environmental Protection Agency (EPA)
receives Hotline complaints of fraud, waste, and abuse within EPA programs and operations.
These complaints include mismanagement or violations of law, rules, or regulations reported by
EPA employees, program participants, and the general public. In October 2008, the OIG
received an allegation against EPA's Antimicrobial Testing Program (ATP). The complaint
alleged that EPA was withholding information on high failure rates for hospital disinfectants and
tuberculocial products from intended users. Based on information provided in the complaint, our
objective was to determine whether EPA is withholding information on product failures from
intended users.
Background
Antimicrobial pesticides are substances or mixtures of substances used to destroy or suppress the
growth of harmful microorganisms on inanimate objects and surfaces. Disinfectants, in
particular, are used on hard inanimate surfaces and objects to destroy or irreversibly inactivate
infectious fungi and bacteria. The EPA Office of Pesticide Programs-Antimicrobials Division
(OPP-AD) is responsible for all regulatory activities associated with antimicrobial pesticides.
These activities include evaluating and registering products. A key project of OPP-AD is ATP,
the post-registration regulatory program designed to evaluate the effectiveness of EPA-registered
disinfectants. The focus of the ATP is on disinfectants most crucial to infection control:
sterilants, tuberculocides, and hospital disinfectants. As of February 2009, EPA had registered
671 disinfectant and tuberculocidal products. Of those registered products, EPA has tested 325.
OPP expects to complete efficacy testing of all currently registered products in 2011.
According to OPP-AD, products are selected for efficacy testing annually. Samples are collected
directly from a manufacturer1 by EPA regional or State inspectors, or purchased directly from
the marketplace. Testing is conducted by the OPP Microbiology Lab in Maryland and three
State-contracted Department of Agriculture laboratories, in Michigan, North Carolina, and Ohio.
To evaluate products, ATP utilizes standard testing methods from the Association of Official
Analytical Chemists.
To evaluate hospital disinfectant product effectiveness, a "60 carrier" use-dilution test is used.
To "pass" the test, no more than one of 60 contaminated test surfaces can show growth by the
target microorganism after product treatment. If a product passes efficacy testing, the Agency
sends a letter to the manufacturer which contains a copy of each product's test results. If the
product fails testing, either a regulatory or enforcement action is taken. Table 1 shows the type
of action based on the number of test failures.
1 A manufacturer can be the owner, operator, or agent of the producing establishment.
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09-P-0152
Table 1: ATP Action Based on Hospital Disinfectant Test Results
Failures (out of 60)
<1
2-3
4+
Type of Action
Manufacturer Notification
Manufacturer Notification and Regulatory Options
Manufacturer Notification and Enforcement Options*
*OECA makes the final decision regarding any enforcement action
Source: OPP-AD
If two or three failures occur, the manufacturer is notified and the product is referred for
regulatory action. According to OPP-AD procedures, regulatory actions can be (1) a change to a
product label claim, or (2) a retest by the manufacturer under different conditions, using an
independent lab, or (3) a retest of a reformulated product. Options for bringing the product into
compliance are sent to the manufacturer via a memo sent from an OPP-AD Product Manager.
The manufacturer has 45 days to respond to the memo or the product can be suspended or
cancelled under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6.
If four or more failures occur, the product is referred for an enforcement action. Per its
procedures, OPP-AD sends OECA a product evaluation report and an enforcement case review.
OECA analyzes this information to determine whether the evidence is sufficient to support an
enforcement action. According to OECA, enforcement actions may also result in a range of
options, including Stop, Sale, Use, or Removal Orders and civil administrative complaints.
Enforcement actions from OECA can result in a press release to the general public concerning
the product.
Prior Reviews
In 2007, the OIG report, EPA Did Not Properly Process a Hospital Disinfectant and Sanitizer
Registration, No. 2007-P-00018, found that OPP-AD accepted registrants' submitted label
claims that were supported by appropriate data and did not conduct its own pre-registration
efficacy testing. The OIG further noted that 2005-2006 efficacy testing results available to the
Agency indicated a 40 percent failure rate for tuberculocidal products and a 29.5 percent failure
rate for hospital disinfectants. The OIG recommended that OPP-AD perform a detailed root
cause analysis to identify why EPA-registered products fail post-registration efficacy testing.
According to OPP-AD, the root cause analysis was conducted and the action items noted are
being addressed.
Scope and Methodology
We conducted our work from February to March 2009. We conducted our work in accordance
with generally accepted government auditing standards unless otherwise noted. These 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
objective. An assessment of management or internal controls was not relevant to this review and
therefore was not conducted.
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09-P-0152
In this review, we defined intended users as those notified of product failures in OPP-AD's
procedures: manufacturers, OPP, and OECA. Notification of product consumers (i.e. hospitals,
nursing homes, and other health care facilities) is not addressed in OPP-AD procedures and was
therefore not within our scope.
To accomplish our objectives, we:
• Reviewed OPP-AD policies and procedures for conducting product labeling compliance
(efficacy testing);
• Reviewed OPP-AD Standard Operating Procedures (SOPs) for product failures and
resulting enforcement actions;
• Interviewed ATP staff at Headquarters to discuss policies and procedures related to
testing failures and enforcement actions;
• Reviewed and analyzed FY (fiscal year) 2008 ATP efficacy testing results for hospital
disinfectants and tuberculocial products (16 products tested); and
• Tracked ATP actions following FY 2008 test failures to determine if OPP withheld
information about failed products from intended users.
The review focused on determining whether information was being withheld and therefore was
not a full assessment of the efficiency and effectiveness of ATP.
Results of Review
EPA Is Not Withholding Information on Product Failures from Intended Users
We found that EPA is not withholding information on efficacy testing results of hospital
disinfectant and tuberculocidal products from intended users. OPP-AD's policies and procedures
require intended users (OECA, OPP, and manufacturers) to be notified when a product fails
efficacy testing. Our review of seven product failures in FY 2008 found that OPP-AD followed
its SOP for product failures by recommending designated regulatory or enforcement actions.
OPP-AD procedures specify what type of action is to be taken based on testing results.
OPP-AD Could Further Improve Its Procedures
OPP-AD staff indicated that the program is in transition. The program is now exploring new
options to increase program capacity for sample collection. OPP-AD staff also indicated that the
program is developing a database to track efficacy test results. The database is scheduled to be
available in 2009. In addition to these improvements, we found that OPP-AD could further
improve its procedures.
We observed that OPP-AD does not maintain a comprehensive Website listing of tested EPA-
registered effective hospital disinfectants and tuberculocidal products as it does with other
disinfectants. For example, a listing of selected EPA-registered effective disinfectants targeting
HIV-1 and the Hepatitis B virus are publicly available on EPA's Website. Additionally, we
2http://www.epa.gov/oppad001/chemregindex.htm
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09-P-0152
observed that OPP-AD does not have a SOP for products that are tested as hospital disinfectants
but do not have a hospital disinfectant label claim. Moreover, OPP-AD staff stated that the ATP
program plans to finish efficacy testing of all currently EPA-registered hospital disinfectants and
tuberculocides by 2011. However, OPP-AD workplans do not state what they will do with the
results of its testing program or what will happen to the program after 2011.
Conclusion
We found that the allegation against EPA was unsubstantiated. We found no evidence of
withholding information per OPP-AD's established procedures. When a product fails, OPP-AD
follows its SOP for product failures. The SOP requires OPP-AD to notify applicants
(manufacturers), OECA, and OPP of efficacy testing results. We also found that OPP-AD could
improve its procedures. OPP-AD could provide publicly accessible information on effective
hospital disinfectants and tuberculocidal products, amend its SOPs to include products without a
hospital disinfectant label claim, and develop a plan for the program after completing efficacy
testing in 2011.
Agency Responses and OIG Evaluation
The Office of Pesticide Programs agreed with our finding and is addressing our suggestions. The
Agency's comments and the OIG's evaluation of those comments are in Appendix A. OPP and
OECA both provided additional technical comments. We made revisions to the report as
appropriate.
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09-P-0152
Status of Recommendations and
Potential Monetary Benefits
POTENTIAL MONETARY
RECOMMENDATIONS BENEFITS (in SOOOs)
Planned
Rec. Page Completion Claimed Agreed To
No. No. Subject Status1 Action Official Date Amount Amount
No recommendations
0 = recommendation is open with agreed-to corrective actions pending
C = recommendation is closed with all agreed-to actions completed
U = recommendation is undecided with resolution efforts in progress
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09-P-0152
Appendix A
Agency Comments and OIG Evaluation
The Agency response to our draft report consisted of a transmittal memorandum from OPP and
OECA. Below we provide our evaluation of the Agency's main points discussed in its
transmittal memorandum.
MEMORANDUM
SUBJECT: Comments on the Draft Hotline Report "Results of Hotline Complaint Review of
EPA's Antimicrobial Testing Program, Project No. OPE-FY09-0006 April 22,
2009"
FROM: Debra Edwards, Ph.D.
Director, Office of Pesticide Programs
TO: Jeffrey K. Harris
Director for Cross-Media Issues
Office of Program Evaluation
Office of Inspector General
This memorandum responds to your request for a response to the draft report prepared by the
Office of the Inspector General, which investigated a Hotline Complaint that the Office of
Pesticide Programs (OPP) is withholding from intended users information on antimicrobial
pesticide product failures identified through the Antimicrobial Testing Program (ATP).
The draft report concludes that the allegation was unsubstantiated and that information is not
being withheld from intended users and I concur with this finding. As noted in the report, OPP
has SOPs in place that address internal and external communication of ATP actions.
The draft report further stated that the Program could provide publicly-accessible information on
effective hospital disinfectants and tuberculocidal products as it does with other disinfectants.
We concur, and OPP is in the process of posting on the web all ATP results covering the
eighteen-year program history. In the near future, we plan to make the ATP web page publicly
accessible to a broad user community including hospitals, nursing homes, and other health care
facilities. This is in addition to our responsibility under the Federal Insecticide, Fungicide, and
Rodenticide Act, which requires the owner, operator, or agent in charge of any inspected
establishment where a sample was collected for testing to be furnished with a copy of the
analysis results if the collected sample is analyzed. The report also suggested that OPP develop
a plan to sustain the program after testing is completed. OPP is already in the process of
developing a strategy that will move the program forward, taking into consideration all the
various aspects of the program and the entities involved, to help build a more robust and
sustainable post-market disinfectants testing program.
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We have provided factual corrections as track changes on the attached draft document and e-
mailed a Microsoft Word version of this memorandum and the track changes to
ansah.lauretta@epa.gov as requested. If you have questions, do not hesitate to contact me or
Marty Monell at (703) 305-7090.
Attachment
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09-P-0152
MEMORANDUM
SUBJECT: Response to the Office of the Inspector General's Draft Hotline Report, "Results
of Hotline Complaint Review of EPA's Antimicrobial Testing Program," Project
No. OPE-FY09-0006 (April 22, 2009)
FROM: Catherine R. McCabe
Acting Assistant Administrator
TO: Jim Jones
Acting Assistant Administrator
Office of Prevention, Pesticides, and Toxic Substances
This memorandum is OECA's response to the draft Office of Inspector General (OIG)
Hotline Report, "Results of Hotline Complaint Review of EPA's Antimicrobial Testing
Program." The draft report focuses on an October 2008 complaint alleging that EPA's
Antimicrobial Testing Program (ATP) was withholding information on product failures from
intended users. This response is limited to the factual accuracy of language in the report related
to enforcement.
At A Glance Cover Sheet The report concludes that the ATP is not withholding
information on product failures from intended users and identifies the Office of Pesticide
Programs - Antimicrobial Division (OPP-AD), the Office of Enforcement and Compliance
Assurance (OECA), and applicants (manufacturers) as the intended users of the information. We
suggest that OIG consider revising the draft report to reflect that hospitals, nursing homes, and
other health care facilities are also intended users of information on product failures.
OIG Response: In this review, we defined intended users as those notified of product
failures in OPP-AD's procedures: manufacturers, OPP, and OECA. Notification of
product consumers (e.g., hospitals, nursing homes, and other health care facilities) is not
addressed in OPP-AD procedures and was therefore not within our scope.
Background Section, vase 1, third paragraph The draft report states, "If a product
passes efficacy testing, a memo is sent to the manufacturer citing the test results." This
statement requires clarification. We suggest that OIG revise this statement, as follows: "If a
product passes efficacy testing, the Agency sends a letter to the manufacturer which contains a
copy of the product test results of each product tested by the ATP."
OIG Response: The wording in the background section has been amended to provide
greater clarity.
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Background Section, page 2, second paragraph The draft report states, "For product
failures of 4 or more out of 60 samples, the product is referred for an enforcement case review
(enforcement action)." This statement is inaccurate. We suggest the OIG revise this statement,
as follows: "For product failures of 4 or more out of 60 carriers, OPP-AD prepares a product
evaluation report and an enforcement case review specifically about the product(s). OPP
forwards these documents to OECA for consideration. OECA analyzes the referral package to
determine whether the evidence is sufficient to support an enforcement action. If OECA
determines that the referral includes sufficient evidence to bring a case, OECA forwards the file
to the regional enforcement office for appropriate action."
OIG Response: We amended our description of the "60 carrier" use-dilution test for
greater clarity. Our description of OECA enforcement options is unchanged as we did
not review the disposition of enforcement review cases stemming from 2008 products
test failures.
Should you have any questions or concerns regarding this response, please contact
OECA's Audit Liaison, Gwendolyn Spriggs at 202-564-2439.
cc: Adam Kushner, OECA
Margaret Schneider, OECA
Lauren Kabler, OECA
Gwendolyn Spriggs, OECA
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Appendix B
Distribution
Office of the Administrator
Acting Assistant Administrator for Prevention, Pesticides, and Toxic Substances
Acting Assistant Administrator for Enforcement and Compliance Assurance
Acting General Counsel
Agency Follow-up Official (the CFO)
Agency Follow-up Coordinator
Acting Associate Administrator for Congressional and Intergovernmental Relations
Acting Associate Administrator for Public Affairs
Audit Follow-up Coordinator, Office of Prevention, Pesticides, and Toxic Substances
Audit Follow-up Coordinator, Office of Enforcement and Compliance Assurance
Acting Inspector General
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