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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Catalyst for Improving the Environment
Evaluation Report
EPA Needs to Assure
Effectiveness of
Antimicrobial Pesticide Products
Report No. 11-P-0029
December 15, 2010
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Report Contributors:
Daniel Carroll
Jerri Dorsey
Jeffrey Harris
Lauretta Joseph
Calvin Lin
Kalpana Ramakrishnan
Abbreviations
AD
Antimicrobial Division
ATP
Antimicrobial Testing Program
EPA
U.S. Environmental Protection Agency
FIFRA
Federal Insecticide, Fungicide, and Rodenticide Act
GAO
U.S. Government Accountability Office
OECA
Office of Enforcement and Compliance Assurance
OIG
Office of Inspector General
OPP
Office of Pesticide Programs
SOP
Standard Operating Procedure
SSURO
Stop Sale, Use, or Removal Order
Cover photos: From left. Staphylococcus aureus bacteria; Pseudomonas aeruginosa
bacteria; and Mycobacterium tuberculosis bacteria. (Centers for Disease
Control and Prevention photos)
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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
11-P-0029
December 15, 2010
Catalyst for Improving the Environment
Why We Did This Review
We initiated this review to
evaluate whether U.S.
Environmental Protection
Agency (EPA) systems ensure
that registered antimicrobial
pesticide products are effective
or that appropriate corrective
actions are taken when products
are found to be ineffective.
Background
Antimicrobial pesticides are
designed to destroy or suppress
harmful bacteria, viruses, and
other microorganisms on
inanimate objects and surfaces
in hospitals and other settings.
EPA's Office of Pesticide
Programs initiated the
Antimicrobial Testing Program
(ATP) to test antimicrobial
products in response to a 1990
U.S. Government
Accountability Office report,
which concluded that EPA
lacked an enforcement strategy
to ensure that registered
disinfectants sold and
distributed worked as claimed
on product labels.
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.qov/oiq/reports/2011/
20101215-11-P-0029.pdf
EPA Needs to Assure Effectiveness of
Antimicrobial Pesticide Products
What We Found
ATP's design and implementation cannot provide assurance to the public that
the product label claims are valid. ATP has been testing to ensure antimicrobial
products, including hospital disinfectants and tuberculocides, meet stringent
efficacy standards. However, after nearly 19 years, over 40 percent of
registered products have not been tested. Those that have been tested have
experienced a consistently high failure rate. During our review, EPA was
requesting test sample submissions from manufacturers using a voluntary
process known as the ATP "direct shipment" initiative, adopted in December
2008. However, the process is considered insufficient for enforcement actions.
Also, EPA does not have a strategy for informing hospitals and other likely
end-users of failed test results or when enforcement actions are taken. EPA's
implementation of the ATP has not delivered on its mission. Rather than
providing increased assurance that antimicrobial products are efficacious, it
raises concerns regarding the integrity of EPA's product registration process.
Ultimately, there may be products on the market that are ineffective.
Sometimes, the response to ATP test failures is retesting, which can take years.
Meanwhile, the product may remain available for use in hospitals and the
public. Testing of samples obtained through the ATP voluntary direct shipment
initiative lacked appropriate chain of custody and therefore the results could not
be considered adequate to support an enforcement action.
What We Recommend
We recommend that EPA redesign its process to verify antimicrobial
effectiveness. The new program should have a testing program that provides
reasonable efficacy assurances for all registered tuberculocides, hospital-level
disinfectants, and registered sanitizers; and all subsequently registered
products. Also, the program should provide an efficient sampling protocol that
enables regulatory and enforcement actions as well as consistent monitoring of
enforcement actions taken by EPA regions.
The Agency agreed that the program should be redesigned, and agreed with
most of the findings of the draft report. The Agency did not agree with how we
characterized some aspects of the program as voluntary. While the Agency did
not explicitly agree with the recommendations, we found the Agency to be
responsive to our recommendations.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
December 15, 2010
MEMORANDUM
SUBJECT:
EPA Needs to Assure Effectiveness of Antimicrobial Pesticide Products
Report No. ll-P-0029
FROM:
Arthur A. Elkins, Jr.
Inspector General
TO:
Steve Owens
Assistant Administrator for Chemical Safety and Pollution Prevention
This is our report on the antimicrobial pesticide products evaluation conducted by the Office of
Inspector General (OIG) of the U.S. Environmental Protection Agency (EPA). This report
contains findings that describe the problems the OIG has identified and corrective actions the
OIG recommends. This 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.
The estimated cost of this report, calculated by multiplying the project's staff days and expenses
by the applicable daily full cost billing rates in effect at the time, is $690,128.
Action Required
In accordance with EPA Manual 2750, you are required to provide a written response to this
report within 90 calendar days. You should include a corrective actions plan for agreed-upon
actions, including milestone dates. Your response will be posted on the OIG's public website,
along with our memorandum commenting on your response. Your response should be provided
as an Adobe PDF file that complies with the accessibility requirements of section 508 of the
Rehabilitation Act of 1973, as amended. The final response should not contain data that you do
not want to be released to the public; if your response contains such data, you should identify the
data for redaction or removal. We have no objections to the further release of this report to the
public. We will post this report to our website at http://www.epa.gov/oig.
If you or your staff have any questions, please contact Wade Najjum at 202-566-0832 or
naiiurn. wade@epa.gov, or Jeffrey Harris at 202-566-0831 or harris.ieffrev@epa.gov.
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EPA Needs to Assure Effectiveness of
Antimicrobial Pesticide Products
11-P-0029
Table of C
Chapters
1 Introduction 1
Purpose 1
Background 1
Noteworthy Achievements 2
Scope and Methodology 2
2 Antimicrobial Testing Program Is Not Ensuring
Efficacy of Products in the Marketplace 3
EPA Has Yet to Test All Registered Antimicrobial Pesticides 3
Registered Antimicrobial Pesticides Frequently Fail Efficacy Testing 4
EPA Actions Vary in Response to Product Failures 5
Since 2008, Enforcement Actions Curtailed by Voluntary Manufacturer
Sample Submissions 6
EPA Relies on the ATP Website to Notify Hospitals and Public Health
Users of Product Failures or Enforcement Action 7
Conclusions 8
Recommendation 9
Agency Comments and OIG Evaluation 9
Status of Recommendations and Potential Monetary Benefits 10
Appendices
A Agency Response 11
B Distribution 17
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Chapter 1
Introduction
Purpose
The objective of this evaluation was to determine whether EPA systems
ensure that registered antimicrobial products are effective or that appropriate
corrective actions are taken when products are found to be ineffective.
Background
Antimicrobial pesticides are designed to destroy or suppress harmful bacteria,
viruses, and other microorganisms on inanimate objects and surfaces in hospitals
and other settings. These pesticides are regulated under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) by EPA's Office of Pesticide Programs
(OPP). EPA reviews test data submitted by manufacturers to verify that products
with a public health claim are effective during the registration process.1 The
Antimicrobial Division (AD) within OPP leads the Antimicrobial Testing
Program (ATP) effort and works closely with OPP's Biological and Economic
Analysis Division, as well as the Office of General Counsel, the Waste and
Chemical Enforcement Division in the Office of Enforcement and Compliance
Assurance (OECA), and regional enforcement offices.
The ATP is a post registration efficacy testing program. According to the Agency,
the intent of the ATP is to determine whether products in the marketplace are
efficacious and continue to perform in a manner consistent with the product's
initial registration. EPA focuses its oversight on infection control products2:
tuberculocides and hospital-level disinfectants.3 The ATP was initiated in
response to a 1990 U.S. Government Accountability Office (GAO) report.4 The
GAO found that EPA lacked an enforcement strategy to ensure that once
registered, disinfectants sold and distributed in the marketplace worked as
claimed on product labels. The GAO noted that historical enforcement and other
data estimated that 20 percent of disinfectants marketed did not work as claimed,
posing health risks to users.
1 Under FIFRA, the registrant of a product with a public health claim is required to submit efficacy, or effectiveness,
data to EPA in support of the product's registration. EPA reviews the effectiveness data as part of the registration
process for each product. If the data meet efficacy standards and all other requirements for registration are met, the
product qualifies for registration and is issued a distinct identification number, or EPA registration number, that
appears on the product's label along with other required statements.
2 Sterilant testing was completed in 1993. In 1996, regulatory authority for certain liquid chemical sterilant products
was transferred to the Food and Drug Administration.
3 A hospital disinfectant must be effective against at least two microorganisms: Staphylococcus aureus and
Pseudomonas aeruginosa. Tuberculocidal products must also be effective against Mycobacterium bovis.
4 GAO/RCED-90-139, Disinfectants: EPA Lacks Assurance That They Work (1990).
11-P-0029
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Noteworthy Achievements
The AD is undertaking a "lean review" of the ATP in an effort to improve the
program by increasing efficiency. The review will focus on process flow in an
effort to streamline the program's processes and activities and eliminate
unnecessary or redundant steps. The first meeting to initiate this review was held
in June 2010.
Scope and Methodology
We performed our evaluation between October 2009 and September 2010 in
accordance with generally accepted government auditing standards. Those
standards require that we plan and perform the review to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our review objectives. The evidence obtained provides a
reasonable basis for our findings and conclusions based on our objectives.
To evaluate EPA's response to ATP product failures, we randomly selected a
sample of 24 hospital disinfectants that failed efficacy tests from fiscal years 2004
through 2009.5 For each sample item, we reviewed the case files and interviewed
appropriate regional and headquarters staff. We interviewed staff from the AD,
OECA, and EPA Regions 2, 3, 4, 5, 7, 8, and 9.
We also reviewed reports and data in support of the status of products tested and
products needing to be tested. Additionally, we met with external stakeholders
and laboratory staff regarding the ATP testing protocols.
Prior Audit Coverage
EPA Office of Inspector General (OIG) Report No. 09-P-0152, Results of Hotline
Complaint Review of EPA's Antimicrobial Testing Program, was issued May 27,
2009 (www.epa.gov/oig/reports/2009/20090527-Q9-P-0152.pdf). In 2008, OIG
received a Hotline allegation that the AD was withholding information on product
failures from its intended users. The report concluded that the Hotline claim was
unsubstantiated.
5 During our sample review, we noted that one of the sample files was lost due to flooding damage at an EPA office.
Only 23 samples were reviewed from our initial random sample of 24.
11-P-0029
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Chapter 2
Antimicrobial Testing Program Is Not Ensuring
Efficacy of Products in the Marketplace
The ATP's design and implementation cannot provide assurance to the public that
the product label claims are valid. The ATP has been conducting post registration
testing to ensure products meet stringent efficacy standards. However, after nearly
19 years, over 40 percent of registered products have not been tested. Those that
have been tested have experienced a consistently high failure rate. Sometimes the
response to ATP test failures is retesting, which can take years. Meanwhile, the
product may remain available for use in hospitals and the public. In December
2008, EPA adopted a voluntary process to acquire test samples from
manufacturers, known as the ATP "direct shipment" initiative. However, testing
of samples obtained through the initiative lacked appropriate chain of custody,
and therefore the results could not be considered adequate to support an
enforcement action. Also, EPA does not have a strategy for informing hospitals
and other likely end-users when enforcement actions are taken but rather relies on
the ATP website to communicate product status to potential end-users.
Ultimately, there may be some products on the market that are ineffective.
EPA Has Yet to Test All Registered Antimicrobial Pesticides
The ATP has been testing antimicrobial products since 1991 with the goal to
ensure that products in the marketplace meet stringent efficacy standards. As of
July 22, 2010, EPA advised that it had tested 379 of 6566 active hospital
disinfectants registered by EPA for efficacy. Over 40 percent of active hospital
disinfectants have yet to be tested. The AD intended to complete efficacy testing
of the remaining 277 (of 656) untested registered hospital disinfectant products by
the end of 2010. Furthermore, while focusing on products with the greatest public
health impacts, the ATP has limited the types of products that it tests to hospital
disinfectants and tuberculocides. However, sanitizers, while a public health
antimicrobial product, are not currently part of ATP and therefore have not been
subject to post registration efficacy testing by EPA.7
Starting in December 2008, the AD requested that product samples be directly
shipped to AD laboratories for efficacy testing, in an effort to increase the number
of products tested. The process was implemented to improve the post-market
evaluations of products, promote product stewardship and efficiency, and obtain
samples of all untested remaining products. Prior to December 2008, the AD
6 AD set the universe of products to be tested as products registered as of September 30, 2009.
7 Sanitizers are used to reduce, but not necessarily eliminate, microorganisms from the inanimate enviromnent to
levels considered safe as determined by public health codes or regulations.
11-P-0029
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relied on sample collection by official federal and state inspectors. According to
OECA staff, using inspectors for sample collection was resource intensive and did
not provide a great number of products being made available for testing. While
this initiative did increase the number of products submitted for testing, it
curtailed EPA's ability to conduct enforcement actions on failed products
discussed in greater detail later in this chapter.
In December 2008, November 2009, and March 2010, the AD issued letters to
primary registrants asking them to voluntarily send samples of their products to a
specified EPA laboratory for testing. During our review, products were only being
tested if manufactures voluntarily submitted samples for testing. Manufacturers
that did respond either submitted samples to be tested, or informed EPA that their
product was not currently in production.8 Over 60 percent of the remaining
untested products have not been scheduled for efficacy testing. AD staff stated
that manufacturers for these products have responded to the direct shipment
letters stating their products are not currently in production. According to AD, it
is their practice to only test products that are currently in production. Therefore,
the AD has removed these products not in production from their list of products to
be tested by December 2010. While these products may not be in production, they
may be available on the market.
One consequence of not having tested over 40 percent of the products is the
potential presence of ineffectual products on the market for extended periods of
time. During our sample review of 23 failed products, we found that the average
time between product registration and product efficacy testing was 14 years.9 The
length of time between product registration and testing of efficacy potentially
increases the amount of time ineffective products are available on the market and
in use in hospital settings.
Registered Antimicrobial Pesticides Frequently Fail Efficacy Testing
Registered EPA antimicrobial pesticides fail EPA's post-registration efficacy tests
at a high rate. Since 2004, on average, more than one-third of tested hospital
disinfectant products have failed efficacy tests under the ATP. Figure 2-1
illustrates that the frequency of hospital disinfectant product failures has been
consistently high since at least 2004. Moreover, half of products tested as
tuberculocides have failed efficacy testing.
8 Manufacturers are requested to submit samples for products that are packaged, labeled, and ready for release for
shipment.
9 This was calculated using the product registration date. However, EPA did not start testing products until 1991.
Many of the products were registered and on the market for years prior to the creation of the ATP.
11-P-0029
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Figure 2-1: ATP product failure rates 2004-2009
~ Total Tested Ĥ Failed
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£ 00
Ĥ H
a
Q.
o
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70
60
50
40
30
20
10
2004 2005 2006 2007 2008 2009
RscalYear
Source: OIG based on analysis of Agency data.
EPA Actions Vary in Response to Product Failures
When registered products fail efficacy testing, EPA is responsible for ensuring
actions are taken to return the product to compliance. The type of action depends
on the severity of the failure.10
The ATP's product failure standard operating procedures (SOPs) state that if 2 or
3 tubes of growth occur, the product is referred for regulatory action. Possible
actions include the manufacturer modifying the label claim, deleting the label
claim, or retesting. If 4 or more failures occur, the product is to be referred to
OECA for an enforcement action. Possible enforcement actions include, but are
not limited to, Stop Sale, Use, or Removal Orders (SSUROs) and Civil
Administrative Complaints. EPA may issue a SSURO prohibiting the person who
owns, controls, or has custody of a violative pesticide or device from selling,
using, or removing that product except in accordance with the provisions of the
SSURO. EPA uses the FIFRA Enforcement Response Policy to determine the
appropriate enforcement response and penalty amount for violations of FIFRA.
EPA may issue a civil administrative complaint to any person who violates
FIFRA. Complaints are usually resolved through issuance of a consent agreement
and final order, which requires payment of a civil penalty and may also require
correction of the violation.
111 Severity as indicated by the number of tubes with microorganism growth out of 60 using the Use Dilution Test.
11-P-0029
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We selected a random sample of 24 products that failed efficacy testing from
2004 through 2009. Eleven of the products were addressed using regulatory
actions. Under regulatory actions, the following options can be considered for
resolution: label amendments, retesting of the product, reformulate the product,
and product cancellation. However, we found that for five failed products for
regulatory corrections, no actions have yet been taken because the manufacturers
requested for their product to be retested.
ATP staff stated that once a sample of the failed product is received from the
manufacturer, it will be placed in the testing queue for retesting. On average, for
the five failed products in our sample, 3.8 years have passed since they had their
first efficacy test. As of August 2010, products on the retest list have not been
retested and are most likely still available on the market.
In contrast, we found that the 12 cases referred to OECA and the regions were
addressed with some form of enforcement action. The various enforcement
actions included payment of fines, voluntary recalling and stop sales of products,
and product label changes. Nine of the 12 manufacturers of the failed products
either voluntarily recalled their products and/or paid fines. In the course of our
case reviews, we noted different regional office reactions to the same failure rates.
Where some regions issued SSUROs for cases involving failed antimicrobial
products, others did not. According to OECA staff, when a SSURO is issued, the
manufacturer is required to provide documentation that it has met the terms and
conditions of the SSURO. However, we found that limited followup is conducted
to ensure compliance.
Since 2008, Enforcement Actions Curtailed by Voluntary Manufacturer
Sample Submissions
Since December 2008, the direct shipment initiative has been used to obtain ATP
test samples and has increased the number of products available for testing.11
However, the initiative curtailed enforcement actions from taking place for failed
products. According to the AD's SOP, if a hospital disinfectant is tested and 4 or
more failures occur, the product should be referred to the regions for an
enforcement action.12 However, we found 25 of the 32 failed products received
via direct shipment are being addressed by regulatory actions instead of an
enforcement action. EPA deviates from its SOPs regarding testing failures of
products received via direct shipment.13 It also refrains from enforcement actions,
such as issuing SSUROs and assessing fines under FIFRA statute.
11 Only 2 of the 24 randomly tested OIG sample items were possibly submitted using the direct shipment method.
Both samples were addressed using regulatory corrections instead of enforcement.
12 Standard Operating Procedure for the Review of Product Failures in the Antimicrobial Testing Program,
September 26, 2007.
13 The AD stated that as a result of the lean process, modified SOPs will be updated and finalized by the end of the
calendar year 2010.
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During our review, OPP maintained that products received by direct shipment
were not enforceable because they did not have a chain of custody. Chain of
custody is often a point of dispute during enforcement trials for failed efficacy
results. The chain of custody is important to ensure that the product sample is not
potentially contaminated during transport from manufacturer site to the lab.
OECA staff said that they would not be able to pursue enforcement cases for
products that do not have chain of custody. According to OECA, enforcement
relating to product failures associated with the voluntary direct shipment initiative
samples could be compromised if sample integrity cannot be assured from the
point of shipment by the registrant or producer to the receiving test laboratory or
if the laboratory fails to adequately implement chain of custody procedures upon
receipt of the direct-shipped samples. If the integrity of the product sample can be
adequately documented, enforcement would not be compromised on the basis of
chain of custody concerns. Regional staff also stated that the direct shipment
letters could request products to be sent using chain of custody. However, the
direct shipment request letters have not required, nor instructed how, to ensure
proper chain of custody.14
According to the Agency during voluntary direct shipment initiative, they retained
its ability to collect products during inspections and therefore could utilize
regulatory and/or enforcement actions where appropriate. AD staff stated that if a
product has "egregious" test failures, or those with 10 or more tubes of growth,
the product would be obtained via the traditional sample collection process and
retested later. This process would require a state or regional inspector to
physically obtain the samples to ensure chain of custody. However according to
OECA, although regions were available during FY2010 to collect ATP samples
upon request, no such on-site sample collections occurred during the period from
October 1, 2009 through September 30, 2010.15 As a result no enforcement
actions were taken during that period.
EPA Relies on the ATP Website to Notify Hospitals and Public Health
Users of Product Failures or Enforcement Actions
EPA does not have a communications strategy for informing end-users16 of
antimicrobial test results or enforcement actions but relies on the ATP website to
communicate product information. Because EPA does not conduct pre-
registration testing, independent verification testing performed by ATP may be
the public's only validation of label claims. EPA's verification of compliance is
through the ATP. While EPA has conducted outreach to healthcare associations to
14 As stated in the Agency's response to the draft report, EPA has taken the first steps to develop additional
procedures to strengthen chain of custody and further facilitate the pursuit of enforcement actions in the future for
direct shipment of products.
15 According to the Agency's response to the draft report, beginning in the first quarter of FY 2011, EPA will be
resuming collection of samples through inspections.
16 In addition to hospitals, other establishments such as beauty and tanning salons, small clinics, veterinaries, and
nursing homes are potential end-users of antimicrobial pesticide products.
11-P-0029
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learn about their use of hospital disinfectants and to discuss the Agency's
registration and review of products, including the ATP, current procedures only
require that the AD notify OECA and the manufacturer when a product fails. The
AD is not required to notify the general public. OECA and regional offices
conducting enforcement actions have the discretion to notify the public of actions
related to product failures. A notification can consist of a press release describing
EPA enforcement actions taken to address noncompliant antimicrobial products.
However, we found that some regions do not issue press releases for cases related
to failed antimicrobial products. Enforcement actions have implications for users
nationwide but may be publicized only within a single region or not at all.
According to AD, EPA relies on the website to inform end users of product
failures.17 However while the website provides information regarding product
status, the website does not clearly identify products that are considered
ineffective.18
Conclusions
As currently executed, the ATP does not ensure that hospital disinfectants and
tuberculocides in the marketplace meet efficacy standards. Although
approximately 60% of the products have undergone post-registration efficacy
testing by EPA, more still needs to be done. Many products have yet to be tested,
and of those that have been tested, failure rates are high. Additionally, sanitizers,
while a public health antimicrobial product, are not currently part of ATP and
have not been subject to efficacy testing by EPA. Neither the design of the
program nor its implementation assures the public that the manufacturer's public
health claims on the label are valid. Additionally, test results of samples that are
submitted via the direct shipment initiative were not considered sufficient for
enforcement. Due to the fact that each region has its own communication policy
and there is no national requirement for issuing enforcement case press releases,
enforcement actions, when taken, are not always communicated to end-users. The
AD's implementation of the ATP has not delivered on its mission. Rather than
providing increased assurance that antimicrobial products are efficacious, the
ATP's program value and the continued high failure rate of products raises
concerns regarding the integrity of EPA's product registration process.
17 In June 2009, EPA developed a web page on the testing status of registered hospital disinfectant products.
18 The ATP web page was updated in October 2010, subsequent to our draft report issuance, to provide the public
with information regarding the total number of registered hospital disinfectant products, which products have been
tested, and those that are in compliance.
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Recommendation
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention:
1. Redesign the process used to verify antimicrobial effectiveness.
Specifically, we recommend a new program design that includes:
(a) A testing program to provide reasonable assurance of the efficacy of
currently registered tuberculocides and hospital-level disinfectants
by the end of 2011. Subsequently registered products should be
subject to same program.
(b) An efficient sampling protocol that enables regulatory and
enforcement actions as appropriate.
(c) Consistent implementation, communication, and followup of
enforcement actions by EPA regions.
(d) A testing program to provide reasonable assurance of the efficacy of
registered sanitizers.
Agency Comments and OIG Evaluation
The Agency agreed that the program should be redesigned, and agreed with most
of the findings of the draft report. The Agency also provided technical
corrections. Based on our analysis of the Agency's comments we made
appropriate corrections. The Agency did not agree with how we characterized
some aspects of the program as voluntary and the implications of the direct
shipment on the Agency's ability to conduct enforcement actions. We believe we
accurately reflect the nature of the voluntary direct shipment initiative that was in
place during the course of our evaluation. Furthermore, based on the Agency
comments, EPA has taken first steps to address chain of custody issues with the
direct shipment initiative to further facilitate the pursuit of enforcement actions in
the future for direct shipment of products.
While the Agency did not explicitly agree with the recommendations, we found
the Agency to be responsive to our recommendations. These recommendations
remain open pending agreed-to corrective actions. We look forward to the
Agency's response to the final report, which should include a corrective action
plan for all agreed-upon actions and milestone dates for accomplishing each of
those actions.
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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
Claimed
Amount
Agreed To
Amount
Redesign the process used to verify antimicrobial
effectiveness. Specifically, we recommend a new
program design that includes:
(a) A testing program to provide reasonable
assurance of the efficacy of currently
registered tuberculocides and hospital-level
disinfectants by the end of 2011.
Subsequently registered products should be
subject to same program.
(b) An efficient sampling protocol that enables
regulatory and enforcement actions as
appropriate.
(c) Consistent implementation, communication,
and followup of enforcement actions by EPA
regions.
(d) A testing program to provide reasonable
assurance of the efficacy of registered
sanitize rs.
Assistant Administrator for
Chemical Safety and
Pollution Prevention
1 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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Appendix A
Agency Response
The response from the Assistant Administrator was signed on October 26, 2010
and received on November 1, 2010.
MEMORANDUM
SUBJECT: Comments on OIG's Draft Evaluation Report "EPA Needs to Assure Effectiveness of
Antimicrobial Pesticide Products" (September 24, 2010/ProjectNo. OPE-09-0020)
FROM: Stephen A. Owens
Assistant Administrator
TO: Arthur A. Elkins, Jr.
Inspector General
This memorandum is in response to the Office of Inspector General's (OIG) Draft
Evaluation Report, entitled EPA Needs to Assure Effectiveness of Antimicrobial Pesticide
Products ("Draft Report"), which evaluated the Agency's Antimicrobial Testing Program (ATP).
The Agency thanks the OIG for this opportunity to comment on the Draft Report and offers the
following comments to clarify characterizations of the ATP for the Final Report.
The Agency agrees with the OIG that the program should be redesigned and with most of
the findings of the Draft Report. The ATP program is critical to EPA's mission of protecting
human health and the environment, and EPA is actively working to improve this program. It is
important to note, however, that the ATP is not a voluntary program, nor is it a stand-alone
program. We want to assure you that the process to register disinfectants making a public health
claim, including products for use in hospitals and healthcare settings, is rigorous. Registrants
conduct efficacy tests according to the Agency's product performance guidelines, using the
methods that are outlined in those guidelines. A product is registered only after the Agency
determines that submitted efficacy data support a finding of product efficacy, and the product
meets other applicable requirements. The ATP complements the registration process by
determining through laboratory evaluations whether hospital disinfectants and tuberculocides
meet the Agency's efficacy standards once they are registered and in the marketplace.
Over the past two years, the Agency has been communicating on a regular basis with
healthcare associations, whose members are the front-line purchasers and users of the hospital
disinfectant products. We inform them about the efficacy of hospital disinfectants, including the
products that fail testing. In fact, the ATP and the issue of failing products were discussed at the
annual meetings of two healthcare associations this year. The associations have informed the
Agency that antimicrobial disinfectants are one part of comprehensive infection control
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programs in hospitals and other healthcare settings. Other important factors in preventing the
spread of infections in healthcare settings, such as how often and how thoroughly the healthcare
staff wash their hands, are also critical. Disinfection of hard surfaces is an important practice,
but it is only one component of a larger program to control the spread of infection in healthcare
settings.
Although there remain products that are currently registered as hospital disinfectants and
that have not been tested, the Agency believes that the majority of the products actually being
used in hospitals and healthcare institutions have, in fact, been tested under the ATP. EPA has
attempted to collect each of the products currently registered under the ATP. As discussed
below, some of these products are not, and have not been for some time, in production.
Generally, those products being produced and marketed were available for collection, have been
collected, and have been tested.
EPA Has Efforts Underway to Improve the Effectiveness of the ATP
The Office of Pesticide Programs (OPP) has undertaken a management effectiveness
review, called the "LEAN Review of the ATP," to increase the efficiency and effectiveness of
product collection, testing, and the resolution of product failures. EPA appreciates that the
OIG's Draft Report highlights the LEAN Review as a noteworthy achievement and states that
the LEAN Review is off to a positive start. As a result of the LEAN Review and the
reestablishment of regular communication on ATP issues across the Agency, EPA has taken the
first steps toward developing a more streamlined and effective program including:
Clarifying the roles and responsibilities of Agency programs and staff to eliminate
redundancies and to shorten the time to test products and act upon results.
Revising Standard Operating Procedures (SOPs) for the collection of sample products by
the EPA regional offices to ensure consistency. The list of targeted samples includes all
remaining products originally requested under the direct shipment program that are in
production but have not yet been sent in by the registrants for testing. The products will
be collected to ensure they are tested or in the queue for testing by December 31, 2010.
Establishing a database to better track milestones for products from the time of receipt by
the lab, through testing and resolution of any testing failures.
Developing amendments to the letter sent to pesticide registrants concerning
antimicrobial product testing failure, to include both regulatory and enforcement actions
and stringent timeframes for response.
Developing additional chain of custody procedures that instruct registrants about how to
ship in a manner that adheres to chain of custody requirements and in a manner that can
be documented. These procedures will be incorporated into the direct shipment letters.
Changes in receipt and handling of the direct shipments at the labs will also be included
in the procedures and will serve to strengthen chain of custody and further facilitate the
pursuit of enforcement actions in the future for direct shipment of products.
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In addition to these efforts, EPA has established intra-Agency teams to examine the long-
term structure of the program. These teams are charged with the following:
Reviewing the method in which failures were handled in the past and how they should be
handled today and in the future. This includes both chemistry and efficacy failures.
Establishing specific timelines for handling failures, such as setting timeframes for failure
letters, as noted above.
Charting a new course for the ATP program. Developing recommendations for new
paradigms for product registration, including examining options for mandating a new
testing paradigm.
Determining the appropriate steps to ensure that sanitizer products are efficacious.
Registration of Antimicrobials
It is important to recognize that the ATP is one part of a larger regulatory framework for
pesticides. EPA registers all antimicrobial products under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA). EPA requires companies seeking to register public health
antimicrobial pesticides, including hospital disinfectants and tuberculocides, to ensure the
effectiveness of their products before the products are registered. Companies are required to
submit efficacy data demonstrating the effectiveness of those kinds of products against specific
microorganisms. Companies conduct efficacy testing according to the Agency's product
performance guidelines, using the methods that are outlined in those guidelines. The Agency
uses efficacy test data to substantiate and determine the adequacy of product use directions and
label claims of efficacy. Once the label is approved and the product is registered, it may enter
the marketplace.
The intent of the ATP is to determine whether products in the marketplace are efficacious
and continue to perform in a manner consistent with the product's initial registration. Post-
registration testing under the ATP is conducted using the same Agency-approved testing
methodologies by which the products were registered.
ATP Is Not a Voluntary Program
It is important to recognize that the ATP is not a voluntary program, as the Draft Report
suggests. In 2009, the Agency instituted an interim voluntary direct shipment program as a one-
time effort to collect previously unavailable products for testing. The Agency retains its ability
to collect products during inspections and to utilize regulatory and/or enforcement actions where
appropriate. Under the interim voluntary direct shipment program, samples were sent to the
laboratory directly by companies in response to a request by the Agency and the chain of custody
was not retained in some instances. Beginning in the first quarter of FY 2011, EPA is resuming
collection of samples through inspections. An inspector will be sent to collect an official chain
of custody sample from each company that failed to respond to the Agency letters requesting
them to submit a product for testing under the direct shipment program. If testing indicates that
the product does not meet the efficacy standards, the Agency will pursue enforcement and/or
regulatory action as appropriate.
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The Draft Report mistakenly indicates that the voluntary direct shipment initiative has
completely eliminated enforcement for failed products, and recommends that the program be
redesigned to establish a sampling protocol that enables enforcement, and that enforcement
actions should be implemented and communicated consistently by EPA regions. While the ATP
direct shipment program was initially focused on a regulatory resolution scheme for failed
products, EPA is establishing revised sampling protocols to ensure that future samples will be
collected in a manner that will facilitate enforcement when samples fail testing. These protocols
will help to ensure consistency in how regions will follow-up on failed samples.
In addition, in December 2009, the Office of Enforcement and Compliance Assurance
(OECA) revised its Federal Insecticide, Fungicide, and Rodenticide Act Enforcement Response
Policy (FIFRA ERP). The FIFRA ERP is used to ensure national consistency in enforcement
actions and is used as a guide by headquarters and the regions in considering the facts and
circumstances of each case. The ERP prescribes a range of enforcement options, which include
the issuance of a Notice of Warning (NOW), a civil administrative complaint, or a Stop Sale,
Use, or Removal Order (SSURO), depending upon the facts and circumstances of each violative
action and establishes a consistent standard for determining when each enforcement option
should be used. NOWs are used to address relatively minor and easily corrected violations.
More serious violations are usually addressed through civil administrative complaints and are
usually resolved through issuance of a consent agreement and final order which requires
payment of a civil penalty and may also require correction of the violation. SSUROs are used to
prohibit violative pesticide products or devices from being sold, used, or removed except in
accordance with the provisions of the SSURO.
Clarification of Actions Taken When a Product Fails under the ATP
Under the ATP, a product passes efficacy testing if no more than one out of 60 tubes
shows growth of the test organism. Under this scenario, the Agency notifies the company
manufacturing the product that its product has passed efficacy testing.
If 2 or 3 tubes of growth of the test organism occur, the company is notified. The
company then has the option of retesting its product, amending the label to delete the claim, or
voluntarily cancelling its product. If retesting is conducted and the product passes, the Agency
will review the data and, if found acceptable, no further testing under the ATP will be conducted.
The product will be deemed to be in compliance and the company will be notified. If the
company's testing results in 2 or 3 tubes of growth of the test organism, actions consistent with
those described below for 4 or more positive tubes will be considered.
If 4 or more tubes of growth of the test organism occur, the registrant must take
corrective action, and regulatory and/or enforcement actions may be taken. Specifically, the
registrant may voluntarily cancel the product, or revise the label to request removal of the
organism(s) for which it is ineffective, along with all references for use of the product in
healthcare settings. Alternatively, the registrant may modify the label directions (e.g., increase
the contact time from 5 minutes to 10 minutes) or reformulate the product. If either of these
latter options is pursued, the product must be retested by the company and the data submitted to
the Agency for review. If the Agency determines that these data demonstrate that the product is
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now efficacious, the Agency will confirm the company's findings by retesting the product under
the ATP.
EPA Targets the Most Critical Products for ATP Testing
As the Draft Report notes, a number of products were not in production when the
registrant received the direct shipment letter. The Agency agrees with the OIG that expeditious
testing of products currently being sold and used in hospitals is a priority. However, there are
various "not in production" scenarios that result in different likelihoods (or not) of a product
being in the current channels of trade. In some business models, one product may be
manufactured to meet current or anticipated demand, and then the production line may switch to
another formula due to different demand. Because it takes approximately 18 months for
products to move through the channels of trade, it is likely that recently produced products are
still available in the marketplace. On the other hand, products for which no production has
occurred for a number of years are unlikely to be available in the marketplace. This scenario
occurs because under FIFRA, registrants are permitted to maintain a registration without
producing a product as long as the company pays an annual maintenance fee.
As mentioned previously in this memorandum, in 2009, the Agency requested ATP
samples be sent in voluntarily by registrants. As a result, registrants declared 143 products to be
"not in production." EPA then researched production data for these 143 products and found that
114 of them had not been produced since 2007. Subsequently, EPA conducted an internet search
and learned that only about 5% of the 143 products were available in the marketplace. Although
the number of these purported "not in production" products available on the marketplace is
small, EPA intends to conduct a rigorous assessment of the status of each product and have
inspectors collect available products.
To further ensure that the Agency targets the most critical products in the ATP, we are
exploring the use of hospital product purchase data to prioritize sample collection and testing.
This information would also help the Agency alert hospitals about product failures.
EPA Works to Communicate Product Failures
EPA has worked hard to communicate product failures to the public. Since 2008, OPP
has conducted outreach to healthcare associations to learn about their use of hospital
disinfectants and to discuss the Agency's registration and review of products, including the ATP.
The Agency has also stressed to industry and many user groups the importance that these
products play in protecting public health. In June 2009, the Agency developed a webpage on the
testing status of registered hospital disinfectant products. On October 15, 2010, OPP updated,
expanded, and improved the website as a part of the LEAN Review. The revised webpage has
information on the status of registered hospital disinfectant products, indicating products meeting
efficacy standards; products not meeting efficacy standards; and products under Agency
(regulatory and enforcement) review. Healthcare facilities can access the webpage for help in
making product purchasing and use decisions.
Recently, the Association for the Healthcare Environment (AHE) (formerly called the
American Society for Healthcare Environmental Services) and the Centers for Disease Control
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and Prevention (CDC) agreed to add links to EPA's ATP webpage to their websites, which will
broaden the audience for this important product efficacy information and provide greater
visibility to the user community. In addition, OPP, OECA, and the regions will continue
partnering on communications. For example, Region 1 has an active hospital communication
program that includes quarterly bulletins, list-serve notices, and an informative website. EPA
will send ATP updates to end users through this network, in addition to expanding the program
to other regions.
Thank you again for the opportunity to comment on the Draft Report. I hope that my
clarifications of EPA positions and facts are helpful as you complete the final report. We will
continue our work to realign the ATP and will develop corrective actions based on the final
report. If you have questions, do not hesitate to contact me or Marty Monell, Deputy Director of
the Office of Pesticide Programs, at (703) 305-7090.
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Appendix B
Distribution
Office of the Administrator
Assistant Administrator for Chemical Safety and Pollution Prevention
Agency Followup Official (the CFO)
Agency Followup Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Audit Followup Coordinator, Office of Chemical Safety and Pollution Prevention
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