i o
_
V ^
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Chemical Safety
EPA Needs a Risk-Based
Strategy to Assure
Continued Effectiveness of
Hospital-Level Disinfectants
Report No. 16-P-0316 September 19, 2016
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This is one of the U.S. Environmental Protection Agency Office of Inspector General's
products associated with antimicrobial testing and disinfectants. For details on other
reports in this area, go to:
• Results of Hotline Complaint Review of EPA's Antimicrobial Testing Program
(09-P-0152. issued May 27, 2009)
• EPA Needs to Assure Effectiveness of Antimicrobial Pesticide Products
(ll-P-0029, issued December 15, 2010)
• Quick Reaction Report: Complete and Clear Information on the Effectiveness of Ebola
Disinfectants Will Better Inform the Public (15-P-0064, issued January 21, 2015)
Report Contributors: Laurie Adams
Daniel Carroll
Jerri Dorsey
Jeffrey Harris
Thane Thompson
Abbreviations
ATP Antimicrobial Testing Program
C. difif Clostridium difficile
CDC Centers for Disease Control and Prevention
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
GAO U.S. Government Accountability Office
OIG Office of Inspector General
TB Mycobacterium tuberculosis (M. tuberculosis)
Cover photos: Cleaning supplies (left) and a hospital room (right). (Centers for Disease
Control and Prevention and California Department of Public Health photos).
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tftD STA/.
U.S. Environmental Protection Agency 16-P-0316
^ \ Office of Inspector General September 19,2016
At a Glance
Why We Did This Review
We conducted this review of the
U.S. Environmental Protection
Agency's (EPA's) Antimicrobial
Testing Program (ATP) to
determine whether the program
ensures the efficacy of EPA-
registered hospital sterilants,
disinfectants and tuberculocides
("hospital-level disinfectants");
and to evaluate options for
improving the ATP.
Antimicrobial pesticides are
designed to destroy or suppress
harmful bacteria, viruses and
other microorganisms on
inanimate objects and surfaces
in hospitals and other settings.
The EPA has a testing
program— the ATP—whose
purpose is to ensure that EPA-
approved hospital disinfectants
and tuberculocides in the
marketplace continue to meet
stringent efficacy standards.
Products found to be effective
are reported to the public on an
EPA website, and those that do
not meet the ATP efficacy
standards need to be brought
into compliance.
This report addresses the
following EPA goal or
cross-agency strategy:
• Ensuring the safety of
chemicals and preventing
pollution.
Send all inquiries to our public
affairs office at (202) 566-2391
or visit www.epa.gov/oiq.
Listing of OIG reports.
EPA Needs a Risk-Based Strategy to Assure
Continued Effectiveness of Hospital-Level
Disinfectants
What We Found
As currently designed and implemented,
the EPA's ATP does not assure that
hospital-level disinfectant products
continue to be effective after they are
registered. Infrequent testing and
reliance on voluntary manufacturer
participation reduce program
effectiveness. Specifically, we found:
EPA-registered hospital disinfectants
help suppress microbes that cause
thousands of serious illnesses every
year. The EPA needs to ensure the
continued efficacy of these
registered products in the
marketplace to protect public health.
• Once the EPA tests a product and it passes, it is listed as Agency Confirmed
Efficacy on the agency's website and is typically not tested again; the long-
term efficacy of the product cannot be assured.
• The EPA relies on manufacturers to voluntarily submit product samples for
testing. In the last 3 years, out of the approximately 300 registered hospital
disinfectant products that have not been tested, manufacturers submitted
only 12 samples to EPA for ATP efficacy testing.
The current ATP design does not consider risk factors when prioritizing and
selecting which antimicrobial products to test, and some of the microorganisms of
greatest concern do not fall within the ATP's current scope.
The EPA is currently re-registering all antimicrobial products and, thereby,
recertifying the efficacy of all registered products. This one-time review of
registered antimicrobial pesticides is a comprehensive review that includes a
review of efficacy. The EPA anticipates the re-registration of antimicrobial
pesticide products to be completed by fiscal year 2021. The EPA testing
conducted by the ATP is redundant in the short term while the EPA is also
re-registering antimicrobial pesticides. However, following this one-time
re-registration review, the EPA needs to have a risk based strategy in place that
assures continued efficacy of public health products, and deters and detects
noncompliance.
Recommendations and Planned Agency Corrective Actions
We recommend that the Assistant Administrator for Chemical Safety and Pollution
Prevention suspend administering the ATP until completion of the one-time
re-registration process, and then develop and implement a risk-based testing
strategy. At a minimum, the antimicrobial testing strategy should include a
framework for periodic testing, define program scope, identify risk factors and
methods for selecting products to test, and designate a date to commence risk-
based post-registration testing. The EPA agreed with our recommendations and
proposed acceptable corrective actions. All recommendations are resolved and
open pending completion.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
September 19, 2016
MEMORANDUM
SUBJECT: EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of
Hospital-Level Disinfectants
Report No. 16-P-0316
FROM: Arthur A. Elkins Jr.
TO:
Jim Jones, Assistant Administrator
Office of Chemical Safety and Pollution Prevention
This is our report on the subject evaluation conducted by the Office of Inspector General (OIG) of the
U.S. Environmental Protection Agency (EPA). The project number for this evaluation was
OPE-FY16-0001. 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 EPA office having primary responsibility for the issues evaluated in this report is the Office of
Chemical Safety and Pollution Prevention's Office of Pesticide Programs.
Action Required
In accordance with EPA Manual 2750, your office provided planned corrective actions in response to
the OIG recommendations. All recommendations are considered resolved. You are not required to
provide a written response to this final report because you provided agreed-to corrective actions and a
planned completion date for the report recommendations. The OIG may make periodic inquiries on your
progress in implementing these corrective actions. Please update the EPA's Management Audit
Tracking System as you complete planned corrective actions. Should you choose to provide a final
response, we will post your response on the OIG's public website, along with our memorandum
commenting on your response. You should provide your response 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 along with corresponding
justification.
We will post this report to our website at www.epa.gov/oig.
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EPA Needs a Risk-Based Strategy to Assure
Continued Effectiveness of Hospital-Level Disinfectants
16-P-0316
Table of C
Chapters
1 Introduction 1
Purpose 1
Background 1
Responsible Office 5
Scope and Methodology 5
2 EPA Needs a Risk-Based Strategy for ATP to
Assure Continued Effectiveness 6
ATP Design Not Ensuring Efficacy of Hospital-Level Disinfectants 6
Antimicrobial Re-Registration Temporarily Makes ATP Redundant 8
Future Program Design Should Have a Risk-Based Approach 9
Conclusion 10
Recommendations 10
Agency Response and OIG Evaluation 11
Status of Recommendations and Potential Monetary Benefits 12
Appendices
A Details on Scope, Methodology and Prior Reports 13
B Agency's Response 15
C Distribution 17
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Chapter 1
Introduction
Purpose
We conducted this review of the U.S. Environmental Protection Agency's
(EPA's) Antimicrobial Testing Program (ATP) to determine whether the program
ensures the efficacy of EPA-registered hospital sterilants, disinfectants and
tuberculocides; and to evaluate options for improving the program.
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. All pesticides—including antimicrobials—sold and distributed
in the United States are regulated and registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)1 by the EPA's Office of Pesticide
Programs. The EPA must ensure that pesticides registered for use in the United
States will not have unreasonable adverse effects on humans and the environment.
The registration process is a scientific, legal and administrative procedure through
which the EPA examines data submitted by registrants to identify the ingredients
of the pesticide; and determine potential risks and benefits associated with the
proposed use sites, application rates, use frequency and timing, and storage and
disposal practices. As illustrated in Figure 1, as part of the registration process,
the EPA evaluates potential human health and environmental effects associated
with use of the product. FIFRA also requires pesticide manufacturers to
consistently formulate a pesticide based on the initial registration.
Although antimicrobial pesticides are subject to the same basic regulatory
provisions of FIFRA as are other pesticides, antimicrobial pesticides are subject to
additional registration requirements. For example, registrants must conduct
efficacy tests according to the agency's product performance guidelines, using the
methods outlined in those guidelines.
1 FIFRA, 7 U.S.C. § 136 et seq.
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Figure 1: Elements of EPA's pesticide registration process
Evaluation of
Human Health
Risk
Pesticide
Registration
Evaluation
Evaluation of
Environmental
Risks
Risk
Assessment &
Peer Review
I
Source: EPA OIG.
Antimicrobial pesticide products are categorized as either "public health" or "non-
public health," depending on the specific claims made on each product's label.
Public health antimicrobial pesticides are regulated more stringently than other
pesticides because serious consequences could arise from use of ineffective
antimicrobials in medical settings. During the registration process for public
health antimicrobials, the EPA reviews the efficacy test data submitted by
manufacturers to verify that products with a public health claim are effective.
According to the EPA, a public health antimicrobial pesticide product is
registered only after the agency determines that submitted efficacy data support a
finding of product efficacy, and the product meets all other applicable
requirements.
Importance of Public Health Antimicrobials
Antimicrobial disinfectants are one part of a comprehensive infection control program in
hospitals and other healthcare settings. Disinfection of hard surfaces is only one
component of a larger program to control the spread of infection in healthcare settings.
According to the EPA, other important factors in preventing the spread of infections in
healthcare settings, such as how often and thoroughly the healthcare staff wash their
hands, are also critical.
Unlike other pesticides where results are usually observable, an end-user of
antimicrobial products cannot visually verify that the product is effective. Due to the
public health implications and the fact that users cannot readily know whether the
products actually kill the germs as claimed, it is imperative that antimicrobial pesticides
used in hospital settings are effective.
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As illustrated in Figure 2, there are various types of public health antimicrobials.
Through the ATP, the EPA currently focuses its post-registration oversight on
infection control products: hospital-level disinfectants and tuberculocides.
Sanitizers are not tested under the ATP, and sterilant testing was completed in
1993. Subsequently, in 1996, regulatory authority for certain liquid chemical
sterilant products was transferred to the Food and Drug Administration.
Figure 2: Antimicrobial pesticides classifications
Products currently tested
by the ATP.
Sterilant
Sanitizer
Limited
Tuberculocide
Hospital
General
Non-Public Health
Public Health
Disinfectant
CL
LO
Source: EPA OIG.
As depicted in Figure 2, disinfectants can be registered as hospital, general or
limited. According to the ATP website, as of July 2016, there were over 600 EPA
registered hospital disinfectants. To be considered as a hospital disinfectant, the
product must be effective against at least two microorganisms: Staphylococcus
aureus and Pseudomonas aeruginosa. Details on these microorganisms follow.
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Risks for Pseudomonas aeruginosa and Staphylococcus aureus
Risks for Pseudomonas aeruginosa infection
According to the Centers for Disease Control
and Prevention (CDC), patients in hospitals—
especially those on breathing machines, with
devices such as catheters, and with wounds
from surgery or burns—are potentially at risk for
serious, life-threatening infections.
Risks for Staphylococcus aureus infection
According to the CDC, anyone can develop a staph
infection, although certain groups of people are at
greater risk, including people with chronic conditions
such as diabetes, cancer, vascular disease, eczema
and lung disease. In a healthcare setting, the risk of a
more serious staph infection is higher because patients
often have weakened immune systems, have
undergone procedures such as surgery, or have
intravenous catheters.
Pseudomonas aeruginosa bacteria.
(CDC photo)
Staphylococcus aureus
bacteria. (CDC photo)
Additionally, the EPA conducts post registration testing of tuberculocide
antimicrobial products. Tuberculocide antimicrobial products must be effective
against Mycobacterium bovis BCG, which according to EPA is a surrogate
organism closely related to Mycobacterium tuberculosis.
Risks for Mycobacterium tuberculosis (M. tuberculosis [TB])
Risks for TB infection
According to the CDC, transmission of TB is a
recognized risk to patients and healthcare
personnel. Transmission of M. tuberculosis in
healthcare settings has been associated with close
contact with persons who have infectious TB,
particularly during the performance of cough-
inducing procedures such as bronchoscopy and
sputum induction. TB can also spread through the
air and travel long distances.
Mycobacterium tuberculosis
bacteria. (CDC photo)
The ATP is intended to complement the registration process by determining,
through laboratory evaluations, whether hospital disinfectants and tuberculocides
are formulated correctly and continue to meet the agency's efficacy standards
once the products are in the marketplace. Under the ATP, samples of EPA -
registered hospital disinfectant and tuberculocide products are tested, and a list of
products found to be effective are reported to potential end users and the public
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via the EPA website, on the ATP web page. Products that do not meet the ATP
standards are subsequently brought into compliance through regulatory or
enforcement measures.
Responsible Office
The EPA office having primary responsibility for the efficacy testing of
antimicrobial pesticides is the Office of Chemical Safety and Pollution
Prevention's Office of Pesticide Programs.
Scope and Methodology
We conducted our work from September 2015 through July 2016. We conducted
this performance audit in accordance with generally accepted government
auditing standards. Those standards require that we plan and perform the audit to
obtain sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that the
evidence obtained provides a reasonable basis for our findings and conclusions
based on our audit objectives.
In support of the objectives, we reviewed relevant guidance documents, testing
standards, and the FIFRA. We also reviewed reports and data in support of the
status of products tested and products needing to be tested. We interviewed staff
involved in administering the ATP from the Office of Pesticide Programs'
Antimicrobial Division and the Biological and Economic Analysis Division. We
also interviewed a staff member in the Office of Enforcement and Compliance
Assurance. Additionally, we met with external stakeholders and staff from the
CDC. Further, to answer the objective of determining which option is the most
beneficial for improving the EPA's ATP, we reviewed the existing testing
program and evaluated the proposed options.
Details on our scope and methodology, including prior reports on this subject, are
in Appendix A.
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Chapter 2
EPA Needs a Risk-Based Strategy for ATP to
Assure Continued Effectiveness
The ATP is intended to ensure that EPA-approved hospital disinfectants and
tuberculocides in the marketplace continue to meet stringent efficacy standards.
However, as currently designed and conducted, the ATP does not assure that hospital
disinfectant products continue to be effective after they are registered. Infrequent
testing, as well as a reliance on voluntary manufacturer sample submissions, reduces
the program's effectiveness. The agency's ongoing one-time re-registration of
antimicrobial products, including hospital-level disinfectants, will recertify the
efficacy of all registered products in the marketplace. However, upon completion of
the re-registration process, the agency needs to design a risk-based testing strategy
that assures efficacy, and deters and detects noncompliance, to ensure that hospital-
level disinfectants continue to work as labelled to protect public health.
ATP Design Not Ensuring Efficacy of Hospital-Level Disinfectants
Program Design Does Not Ensure Continued Efficacy
The ATP is not administered in a way that assures products continue to meet efficacy
standards. Once the EPA tests a product and it passes, the product is listed as
Agency Confirmed Efficacy on the agency's website, and typically is not tested
again. While this one-time test does determine the efficacy of the product at the time
of testing, it cannot assure that any product on the effective list continues to be
effective. Even though FIFRA requires pesticide registrants to consistently formulate
a pesticide based on the initial registration, a risk exists that the formulation could
change, rendering the product less effective or ineffective. According to the EPA,
some possible causes of a formulation change include:
• Inconsistencies in distributor products.2
• Product degradation over time.3
• Production facility problems (e.g., improper quality assurance).
Since the EPA only tests products once, there could be products listed as effective
on the agency's website that were tested several years ago but could now be
ineffective, due to the reasons cited above.
2 Each primary product may support tens and sometimes hundreds of "supplemental distributor" products.
According to the EPA, these products, which are sold by other companies, must be identical in both claim and
formulation with the primary product. However, inconsistencies in distributor products could occur. EPA staff added
that primary registrants are responsible for ensuring that supplemental distributors sell products that have identical
formulations and claims to the parent product.
3 Storage stability data (1 year) is required for all products during the initial registration.
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Problems With Collecting Samples for ATP Testing
The number of ATP tests conducted, and the source of test samples, has
fluctuated over the course of the program. Prior to 2008, the EPA relied on
sample collection by federal and state inspectors. In December 2008, the agency
instituted a direct-shipment initiative whereby the EPA requested manufacturers
to voluntarily ship product samples to the EPA for efficacy testing. This change
allowed the EPA to increase the number of samples received, and the number of
tests conducted in 2010 and 2011. While this voluntary direct-shipment initiative
did increase the number of products submitted for testing, it curtailed the EPA's
ability to conduct enforcement actions on failed products, due to chain of custody
concerns. As depicted in Figure 3, after a surge of testing in 2010 and 2011,
voluntary submissions to the ATP fell sharply. According to the agency, it did not
actively request sample submissions while waiting for the anticipated
improvements to the efficacy testing method.4
Figure 3: Antimicrobial hospital disinfectants tested for efficacy, 2004-2015
120
100
80
60
40
20
0
Antimicrobial Hospital Disinfectants
Tested for Efficacy
114
38
24 ¦ 26 25
I I I I
16
¦ _1 3 i
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Source: OIG analysis of EPA data.
While the EPA has continued to rely on the voluntary submission by
manufacturers of product samples for testing, this method of collection has
presented challenges. Of more than 300 untested registered hospital disinfectant
products, only 12 were tested for efficacy by the ATP in the last 3 years.
According to ATP staff, not all registrants were willing to submit samples, and
the ATP staff also had concerns that some registrants could create "special"
batches for testing. ATP staff added that some of the 300 untested products, while
registered, are currently not in production. Lastly, as sample submission was
4 In November 2013, the agency adopted the most recently revised Use-Dilution Method published by the
Association of Official Analytical Chemists International, an international non-profit scientific organization that
develops microbiological and chemical standards and analytical methods.
16-P-0316
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voluntary, the ATP staff said they could not anticipate when samples would be
received, creating work-load challenges.
Currently, registrants of hospital disinfectants in liquid form have the option of
voluntarily submitting data for their products that were tested using the 2013
version of the Use-Dilution Method for Testing Disinfectants.5
Antimicrobial Re-Registration Temporarily Makes ATP Redundant
The EPA initiated the one-time re-registration of antimicrobial pesticide products,
which included products with public health-related efficacy claims, in part, to
ensure the products are supported by acceptable efficacy data. Re-registration
includes a data request to registrants for efficacy test data. If acceptable data are
not received, the EPA can take those
products off the market. Because of
advances in scientific knowledge, the
law requires that pesticides first
registered years ago be re-registered to
ensure they meet current scientific and
regulatory standards. This one-time
re-registration process requires
registrants to submit efficacy data
using the new test method, or ensure
that the data submitted previously
complies with the current standards
and guidance.6 The EPA anticipates the
re-registration of antimicrobial
pesticide products to be completed by
fiscal year 2021.
Re-registration of
Antimicrobials Pesticides
The re-registration process was authorized
by the 1988 amendments to FIFRA.
Re-registration is a one-time re-evaluation
of pesticides first registered before
November 1984. In evaluating pesticides for
re-registration, the EPA obtains and reviews
a complete set of studies from pesticide
producers, describing the human health and
environmental effects of each pesticide.
The agency imposes any regulatory
controls needed to effectively manage each
pesticide's risks. The EPA then re-registers
pesticides that can be used without posing
undue hazards to human health or the
environment.
It is redundant for the EPA to be testing antimicrobial hospital-level disinfectants
for continued post-registration efficacy while these products are also being
re-registered by the EPA. The re-registration of antimicrobial pesticide products is
a more comprehensive approach to ensure product efficacy, rather than only
testing a few products a year under the ATP. According to Office of Pesticide
Programs staff, the re-registration process will increase the level of confidence in
the efficacy of registered hospital-level disinfectant products. However,
following this one-time re-registration of antimicrobial pesticides, the EPA needs
5 This option is not available for other formulation types, such as spray and towelette products, or for products with
claims against Mycobacterium.
6 According to the agency's July 2015 Efficacy Testing Standards for Product Data Call-In Responses, registrants
must comply with the testing standards found in the agency's current 810 series. Product Performance Test
Guidelines, published in 2012. These guidelines identify the efficacy data needed to support re-registration based on
the product-specific efficacy claims. This includes data on the organisms needed to support general efficacy label
claims (e.g., disinfectant, sanitizer, etc.); as well as any additional bacterial, viral and fungal organisms on the
product label.
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to have a testing program in place to ensure that registered public health
antimicrobial products continue to be effective once on the market.
Future Program Design Should Have a Risk-Based Approach
The current ATP design does not consider risk to prioritize and select
antimicrobial products for testing. The ATP has consistently focused on testing
tuberculocides and hospital disinfectant products to ensure efficacy post
registration. The ATP design considers all hospital-level disinfectants equal in
their importance to controlling environmental transmission of infectious
microorganisms. Further, the EPA intended to test all registered tuberculocides
and hospital disinfectant products. However to date, according to the agency's
website, all of the registered tuberculocides and hospital disinfectants have not
been tested. According to the agency, with over 600 hospital disinfectants
registered and a capacity for testing a limited number of products every year, it
struggled to get through all products in the market.
Despite having limited testing capacity, the ATP is not designed to target products
for testing based on risks to public health. For example, the ATP currently does
not take into account product label claims or CDC prevalence data when
determining which products to test. Furthermore, while the EPA currently focuses
its ATP efficacy testing on tuberculocides and hospital disinfectant products, the
microorganisms of greatest concern for healthcare-associated infections are not
specifically tested in the ATP. For example, Clostridium difficile (C. diff) has
become an increasing public health concern; however, testing the efficacy of label
claims associated with C. diff is not part of the scope of the ATP. Healthcare-
associated infection prevalence data could be an important consideration for EPA
decisions on which products to target for testing.
Clostridium difficile: A Public Health Concern
Clostridium difficile (C. diff) is a bacterium that causes
inflammation of the colon, known as colitis. C.diff
became an increasing public health concern between
2007 and 2008. According to the CDC, C.diff is
responsible for 337,000 infections and 14,000 deaths
in the United States every year. In 2009, the agency
issued interim guidelines to evaluate the effectiveness
of any product applying for a C.diff claim. This
guidance was updated in June 2014. According to the
agency, of the over 600 registered hospital
disinfectants, 48 products have label claims for
efficacy against C.diff.
Additionally, the agency could consider other risk factors—such as compliance
history, sales and production data, and historical testing data—when determining
which products should be tested in a given year. The agency is currently
considering the future direction of the ATP and making an allowance for a
Medical illustration of
Clostridium difficile.
(CDC image)
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redesign of the program. ATP staff have acknowledged that having a targeted
sampling approach should be part of their redesign. A risk-based prioritization for
future testing would provide a roadmap for which disinfectants to target.
To further ensure that the agency targets the most critical products to be tested in
the ATP, some factors to consider when developing a risk-based review process
are outlined below.
Factors That Could be Considered by the EPA in Conducting a
Risk-Based Sampling Approach
•
Compliance history.
• Public health priority areas.
•
Historical test data.
• CDC prevalence data.
•
Re-registration efficacy data.
• Development of new testing methods.
•
Sales data.
• Elapsed time since last EPA review.
•
Production data.
• Product label claims.
•
Distributor products.
• Product use site.
•
Organisms that cause
healthcare-associated infections.
Conclusion
The ATP is intended to help protect public health by ensuring that registered
hospital disinfectants and tuberculocides in the marketplace continue to meet
stringent efficacy standards. Although the program as currently designed and
conducted does not assure that most hospital disinfectant products continue to be
effective, at this point it is redundant and unnecessary to make adjustments, since
the EPA is concurrently having the products re-registered. However, following
re-registration, the EPA needs to implement a risk-based strategy for a post
registration testing regime. The strategy needs to assure that antimicrobial
products used in hospital settings remain effective while in the marketplace. The
strategy also needs to deter and detect noncompliance, to ensure that hospital-
level disinfectants continue to work as labelled to protect public health.
Recommendations
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention:
1. Suspend administering the current Antimicrobial Testing Program until
completion of the one-time re-registration process.
2. Develop a risk-based antimicrobial testing strategy to assure the
effectiveness of public health pesticides used in hospital settings once
products are in the marketplace. At a minimum, the strategy should:
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a. Include a framework for periodic testing to assure products
continue to be effective after registration.
b. Define a program scope that is flexible and responsive to current
and relevant public health risks.
c. Identify risk factors for selecting products to test.
d. Identify the method to be used for obtaining samples for testing.
e. Designate a date to commence risk-based post-registration testing.
Agency Response and OIG Evaluation
The agency agreed with our findings and recommendations, and provided
corrective actions and estimated completion dates that meet the intent of the
recommendations. Based on the agency's written response, the recommendations
are resolved and open with corrective actions ongoing. No further response to this
report is required. The agency's detailed response is in Appendix B. The agency
also provided technical comments on the draft report, which we incorporated into
our final report as appropriate.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Rec.
No.
Page
No.
Subject
Status1
Action Official
Planned
Completion
Date
Potential
Monetary
Benefits
(in $000s)
10 Suspend administering the current Antimicrobial Testing
Program until completion of the one-time re-registration
process.
10 Develop a risk-based antimicrobial testing strategy to
assure the effectiveness of public health pesticides used in
hospital settings once products are in the marketplace. At a
minimum, the strategy should:
a. Include a framework for periodic testing to assure
products continue to be effective after registration.
b. Define a program scope that is flexible and
responsive to current and relevant public health risks.
c. Identify risk factors for selecting products to test.
d. Identify the method to be used for obtaining samples
for testing.
e. Designate a date to commence risk-based post-
registration testing.
Assistant Administrator for 11/30/17
Chemical Safety and
Pollution Prevention
Assistant Administrator for 11/30/18
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 unresolved with resolution efforts in progress.
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Appendix A
Details on Scope, Methodology and Prior Reports
In support of the objective, we reviewed the FIFRA, relevant background information, guidance
documents and efficacy testing standards. Specifically, we reviewed the Pesticide Registration
Manual relating to antimicrobial registration. We reviewed the EPA Strategic Plan for fiscal
years 2014-2018, and relevant budget information. We reviewed reports and data in support of
the status of products tested and products needing to be tested. We analyzed the status of the
ATP list of products tested on the EPA website. We gathered data on the most recent samples
tested and actions taken based on the testing results. We obtained information and guidance
documents on recent upgrades made to testing methods and the pesticide re-registration process.
We interviewed staff in the Office of Pesticide Programs' Antimicrobial Division involved in
administering the ATP. We also met with an Office of Enforcement and Compliance Assurance
staff member to obtain an understanding of their role and activities regarding the oversight of
antimicrobials and the ATP.
The Office of Pesticide Programs requested our assistance in reviewing future design options for
ATP, and requested guidance in developing the future direction of the ATP. In response to this
request, the objective of fieldwork was to evaluate options for meeting the goals and intent of the
ATP. To answer the objective of determining which option is the most beneficial for improving
the EPA's ATP, we reviewed the existing testing program and evaluated the proposed options
for costs, stakeholders and agency's considerations. We reviewed the options provided by the
agency to see if:
• The option was consistent with the statement mission.
• The design option would address the risk that product formulations could change over time.
During our discussions with the EPA, Office of Pesticide Programs staff provided us with
potential options in redesigning the ATP. We also gathered information from the Office of
Pesticide Programs' Biological and Economic Analysis Division regarding its role, capacity and
resource capabilities under the options being considered. We reviewed the options based on the
information provided by the agency. Additionally, we met with external stakeholders, including
manufacturers, an organization that represents end-users of hospital disinfectant products, and
staff from the CDC.
Prior Reports
U.S. Government Accountability Office (GAO) Report No. RCED-90-139, Disinfectants:
EPA Lacks Assurance They Work, issued August 30,1990: GAO found that the EPA did not
know whether disinfectants kill the germs claimed on product labels. GAO reported that market
forces cannot be relied upon to control disinfectant efficacy problems because users cannot
visually identify ineffective products. GAO also found that the EPA lacked an enforcement
strategy to ensure that, once registered, disinfectants sold and distributed in the marketplace
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worked as claimed on product labels. GAO noted that historical enforcement and other data
estimated that 20 percent of disinfectants on the market did not work as claimed, posing health
risks to users. The ATP program was initiated in response to this GAO report.
EPA OIG Report No. 09-P-0152, Results of Hotline Complaint Review of EPA '.s
Antimicrobial Testing Program, issued May 27, 2009: In 2008, the OIG received a hotline
allegation that the Antimicrobial Division was withholding information on product failures from
its intended users. The report concluded that the hotline claim was unsubstantiated. The report
did not contain any recommendations.
EPA OIG Report No. ll-P-0029, EPA Needs to Assure Effectiveness of Antimicrobial
Pesticide Products, issued December 15, 2010: This report recommended that the EPA improve
its ATP program by redesigning its process to verify antimicrobial effectiveness. The EPA issued
a letter in February 2012 stating that all agreed-to actions had been completed.
EPA OIG Report No. 15-P-0064, Quick Reaction Report: Complete and Clear Information on
the Effectiveness of Ebola Disinfectants Will Better Inform the Public, issued January 21,
2015: The OIG found that the EPA's web pages should have ongoing, clear information about the
effectiveness of disinfectants for use against the Ebola virus. The report included
recommendations to modify EPA web page information to indicate the status of the EPA's ATP
testing on all products listed, and that product testing status was clearly reported. The agency
agreed with the recommendations and completed corrective actions prior to issuance of the report.
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Appendix B
Agency's Response
August 24, 2016
MEMORANDUM
SUBJECT: OCSPP's Comments on the OIG's Draft Report: "EPA Needs a Risk-Based
Strategy to Assure Continued Effectiveness of Hospital-Level Disinfectants"
Project No. OPE-FY16-0001
FROM: James J. Jones, Assistant Administrator
Office of Chemical Safety and Pollution Prevention
TO: Arthur A. Elkins, Jr.
Inspector General
This memorandum is in response to the Office of Inspector General's (OIG) Draft Report
entitled "EPA Needs a Risk-Based Strategy to Assure Continued Effectiveness of Hospital-Lev el
Disinfectants." The Office of Chemical Safety and Pollution Prevention (OCSPP) appreciates
the OIG's evaluation of EPA's Antimicrobial Testing Program (ATP) to determine whether the
program ensures the efficacy of EPA-registered hospital sterilants,1 disinfectants and
tuberculocides; and to evaluate options for improving the program.
The OCSPP welcomes the Draft Report recommendations for redesigning the ATP with a
risk-based testing strategy. We agree that the recommendations will improve the program's
effectiveness and that the combination of the on-going antimicrobial re-registration process and
the revised Use Dilution Method will increase the quality of the efficacy data supporting hospital
disinfectant product registrations. In a separate document, OCSPP is also providing the OIG with
Technical Comments on the Draft Report. We plan to implement the recommendations, as
detailed in the following:
I. OCSPP's Response to the Recommendations
Recommendation 1: Suspend administering the current ATP until completion of the re-
registration process.
o OCSPP Response: The OCSPP agrees with the OIG's recommendation to suspend the
current ATP program until completion of the re-registration process. We agree with the
OIG report noting the redundancy of the ATP program with the antimicrobial re-
1 Sterilant testing was completed in 1993. In 1996, regulatory authority for certain liquid chemical sterilant products
was transferred to the Food and Drug Administration.
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registration process. Through the submittal of a combination of new studies and citation
of higher quality studies, the re-registration program will increase the level of
confidence in the efficacy data supporting all hospital disinfectant product registrations.
Furthermore, the re-registration regulatory process enables the EPA to upgrade the
information supporting many products over a short period of time in contrast to the
current ATP. The Office of Pesticide Programs (OPP) will develop a plan to coordinate
and implement the discontinuation of the present-day ATP.
Timeframe: OCSPP will close the ATP program by November 2017.
OIG Recommendation 2: Develop a risk-based strategy to assure the effectiveness of public
health pesticides used in hospital settings once products are in the marketplace. At a
minimum, the strategy should:
a. Include a framework for periodic testing to assure products continue to be effective
after registration.
b. Define a program scope that is flexible and responsive to current and relevant public
health risks.
c. Identify risk factors for selecting products to test.
d. Identify the method to be used for obtaining samples for testing.
e. Designate a date to commence risk-based post-registration testing.
OCSPP Response: The OCSPP agrees with the OIG's recommendation that a risk-based
strategy is needed to assure the effectiveness of public health pesticides used in hospital
settings once products are in the marketplace. In developing a risk-based strategy, the
program will consider all five recommendations listed in the OIG report. OCSPP will
consider developing the strategy using a two-year phased approach - defining the criteria for
completing recommendations stated in (a) and (b) in the first year, and defining the criteria
for completing recommendations stated (c), (d) and (e), in the second year.
Timeframe: By November 2018, OCSPP will develop a risk-based strategy to assure the
effectiveness of public health pesticides used in hospital settings once products are in the
marketplace.
II. Conclusion and Contact Information:
Overall, OCSPP is pleased with the thoughtful nature of the OIG's Draft Report in
providing direction regarding the future of the ATP, and looks forward to the implementation of
the recommendations.
If you have any technical questions regarding these responses, please contact Jennifer
McLain, OPP, mclain.iennifer@epa.gov. If you have other questions, please contact Janet
Weiner, OCSPP's Audit Liaison, at weiner.ianet@epa.gov.
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Distribution
Appendix C
Office of the Administrator
Assistant Administrator for Chemical Safety and Pollution Prevention
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Deputy Assistant Administrator for Chemical Safety and Pollution Prevention
Director, Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention
Audit Follow-Up Coordinator, Office of Chemical Safety and Pollution Prevention
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