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

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF INSPECTOR GENERAL 
 

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) 
 

 

 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, 

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. 

U.S. Environmental Protection Agency 

Office of Inspector General 

At a Glance 
 

May 27, 2009 

MEMORANDUM

SUBJECT: Results of Hotline Complaint Review of EPA’s 

Antimicrobial Testing Program 

 Report No. 09-P-0152 

FROM: Wade T. Najjum 

 Assistant Inspector General 

 Office of Program Evaluation 

 

TO: 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.jeffrey@epa.gov; or Lauretta Joseph, Project Manager, at 212-637-3049 or 

ansah.lauretta@epa.gov. 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460

OFFICE OF 

INSPECTOR GENERAL
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 
 09-P-0152 

 

1 

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. 
 09-P-0152 

 

2 

Table 1: ATP Action Based on Hospital Disinfectant Test Results 

Failures (out of 60) Type of Action 

≤ 1 Manufacturer Notification 

2-3 Manufacturer Notification and Regulatory Options 

4+ 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. 
 09-P-0152 

 

3 

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 EPAregistered 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.2

 Additionally, we 

 

2

http://www.epa.gov/oppad001/chemregindex.htm 
 09-P-0152 

 

4 

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.
 09-P-0152 

 

5 

Status of Recommendations and 

Potential Monetary Benefits 

RECOMMENDATIONS 

POTENTIAL MONETARY 

BENEFITS (in $000s) 

Rec. 

No. 

Page 

No. Subject Status1 Action Official 

Planned 

Completion 

Date 

Claimed 

Amount 

Agreed To 

Amount 

 No recommendations 

1 O = 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 
 09-P-0152 

 

6 

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. 
 09-P-0152 

 

7 

We have provided factual corrections as track changes on the attached draft document and emailed 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 
 09-P-0152 

 

8 

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. 

Background Section, page 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: 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. 

OIG Response: The wording in the background section has been amended to provide 

greater clarity. 
 09-P-0152 

 

9 

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.” 

 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 

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. 
 09-P-0152 

 

10 

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