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OFFICE OF INSPECTOR GENERAL
Catalyst for Improving the Environment
Public Liaison Report
EPA Did Not Properly Process
a Hospital Disinfectant and
Sanitizer Registration
Report No. 2007-P-00018
March 29, 2007

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Report Contributors:
Tapati Bhattacharyya
Larry Dare
Bao Chuong
Paul McKechnie
Christine Baughman
Abbreviations
EPA	U.S. Environmental Protection Agency
GAO	Government Accountability Office
OIG	Office of Inspector General
OPP	Office of Pesticides Program
OPP-AD	Office of Pesticides Program-Antimicrobials Division
PRIA	Pesticides Registration Improvement Act
PSB	Product Science Branch
RMB II	Regulatory Management Branch II

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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
2007-P-00018
March 29, 2007
Why We Did This Review
We did this review in response
to a hotline complaint alleging
that a pesticide product was
improperly registered by the
U.S. Environmental Protection
Agency (EPA) in 2004, over
staff concerns and without the
required fee. We sought to
determine whether the product
contained a new active
ingredient, which would have
lengthened the approval
process and required EPA to
bill the registrant a $50,000
registration fee. We also
looked at whether EPA
resolved staff concerns and
science review deficiencies
prior to registration.
Background
The product reviewed is a
disinfectant and sanitizer
designed to kill bacteria and
viruses on hard, non-porous,
inanimate surfaces, primarily in
hospital patient care areas. The
product has failed EPA efficacy
tests and EPA has asked the
manufacturer to voluntarily
withdraw the product. We do
not include the name of the
product or manufacturer in this
report due to possible
enforcement action.
For further information,
Contact our Office of
Congressional and Public
Liaison at (202) 566-2391.
To view the full report,
click on the following link:
www.epa.qov/oiq/reports/2007/
20070329-2007-P-00018.pdf
Catalyst for Improving the Environment
EPA Did Not Properly Process a Hospital
Disinfectant and Sanitizer Registration
What We Found
EPA's Office of Pesticides Program-Antimicrobials Division (OPP-AD) did not
properly process registration for an antimicrobial pesticide that was the subject of
our review. Specifically:
•	OPP-AD did not properly recognize that the antimicrobial pesticide
product contained a new active ingredient. As a result, OPP-AD did not
collect the registration fee for products with new active ingredients.
For this particular product, the fee would have been $50,000.
•	OPP-AD branch management did not address all staff concerns regarding
product registration. Staff consistently indicated a former manager
exerted verbal pressure for them to approve the product reviewed. This
contributed to a working environment of distrust, fear, and confusion that
current OPP-AD managers must work hard to overcome.
•	OPP-AD branch management did not resolve all science reviewers"
concerns regarding the product.
The deficiencies generally occurred due to a lack of procedures. Throughout our
review, a lack of documentation made it difficult for us to identify the rationale
for decisions made. Post-registration testing, at the Director's request, found
problems regarding the effectiveness of the product. This led to EPA
enforcement officials asking the registrant to voluntarily withdraw the product
from the marketplace.
What We Recommend
We recommend that the Director, Office of Pesticides Program, establish
procedures to determine the accuracy of active ingredient status and to assign
responsibilities, document and resolve discrepancies between staff concerns and
management decisions, and document the resolution of data deficiencies. We
also recommend surveying staff to determine if they still have concerns about
their work environment and, if so, take steps to resolve their issues. In addition,
we recommend performing a detailed root cause analysis of products similar to
the one that failed to identify why a significant number of antimicrobial products
are not effective. The Agency generally agreed with our conclusions and
recommendations and is taking action to correct the issues identified in our
report.

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^tDS%
|	\	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
|	|	WASHINGTON, D.C. 20460
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OFFICE OF
INSPECTOR GENERAL
March 29, 2007
MEMORANDUM
SUBJECT:
FROM:
EPA Did Not Properly Process a Hospital Disinfectant and
Sanitizer Registration
Report No. 2007-P-00018
Eileen McMahon
Assistant Inspector General for Congressional and Public Liaison

TO:
Jim Gulliford, Assistant Administrator for
Office of Prevention, Pesticides, and Toxic Substances
This is our report on our review of the issues surrounding the registration of a hospital
disinfectant and sanitizer that resulted from an Office of Inspector General (OIG) Hotline
complaint. The report contains findings and recommendations that describe needed
improvements the OIG has identified and corrective actions the OIG recommends. This report
represents the opinion of the OIG and the findings contained in this report do not necessarily
represent the final U.S. Environmental Protection Agency (EPA) position. Final determinations
on matters in this report will be made by EPA managers in accordance with established
resolution procedures.
The findings in this report are not binding in any enforcement proceedings brought by EPA or
the Department of Justice under the Federal Insecticide, Fungicide, and Rodenticide Act to
recover costs.
The estimated cost of this report - calculated by multiplying the project's staff days by the
applicable daily full cost billing rates in effect at the time is $300,881.
Action Required
In accordance with EPA Manual 2750, you are required to provide this office with a written
response within 90 days of the final report date. You should include a corrective action plan for
agreed upon actions, including milestone dates. We have no objections to the further release of
this report to the public. This report will be available at http://www.epa.gov/oig.

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If you or your staff have any questions, please contact me at 202-566-2391; or Paul McKechnie,
Product Line Director for Public Liaison, at 617-918-1471 or mckechnie.paul@epa.gov.

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EPA Did Not Properly Process a
Hospital Disinfectant and Sanitizer Registration
Table of C
Chapters
1	Introduction		1
Purpose		1
Background		1
Scope and Methodology		2
Prior Audit Coverage		4
2	Lack of Procedures Led to Registration Not Being Processed Properly		5
Misclassifying Active Ingredient Status May Have Resulted in Lost Fees		5
OPP-AD Did Not Appear to Address Staff Concerns		7
Not All Science Review Deficiencies Resolved		8
Distributor Products Were Subsequently Registered		10
Post-Registration Efficacy Test Results Show Problems		10
Conclusions		11
Recommendations		11
Agency Comments and OIG Evaluation		12
Status of Recommendations and Potential Monetary Benefits		14
Appendices
A Chronology of Product Registration	 15
B Agency Response to OIG Draft Report	 17
C Distribution	 27

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Chapter 1
Introduction
Purpose
On May 5, 2005, the U.S. Environmental Protection Agency (EPA) Office of
Inspector General (OIG) received an anonymous hotline complaint. The
complaint alleged improprieties within EPA's Office of Pesticides Program-
Antimicrobials Division (OPP-AD) in the registration of an antimicrobial
pesticide for use as a hospital disinfectant and sanitizer. In particular, the
complainant alleged that the product contained a new active ingredient but was
not registered as such, resulting in EPA not billing the registrant for the $50,000
registration fee. The complainant also alleged EPA registered the product over
the objections of staff, and that a former branch chief coerced staff into approving
the registration.
Our overall objective was to determine whether EPA appropriately registered the
hospital disinfectant and sanitizer product in question. Based on concerns raised
in the hotline complaint, we sought to answer the following questions:
1.	Did the product contain a new active ingredient and, if so, was the
application processed as though it did?
2.	Did staff express concerns about the product registration and, if so, what
steps did EPA managers take to resolve their concerns? What pressure, if
any, did EPA managers exert on staff to approve the registration?
3.	Were science review deficiencies resolved? Were the active ingredients
listed on the label complete and accurate?
We do not disclose the name of the product or the product's manufacturer in this
report due to possible enforcement action.
Background
Institutions, such as hospitals, and individuals spend about $1 billion each year on
antimicrobial products. More than 5,000 such products, containing about 275
active ingredients, are currently registered with EPA and sold in the marketplace.
Nearly 60 percent of antimicrobial products registered, such as the one reviewed,
are intended for use in hospitals and other health care environments.
In 2004, EPA conditionally registered an antimicrobial pesticide manufactured by
a privately held company. The pesticide was to be used primarily as a hospital
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disinfectant and sanitizer. The registrant submitted its application to EPA on
March 22, 2004. EPA conditionally approved the product on October 21, 2004.
This approval allowed the registrant to market the product and enter into
negotiations with distributors. A chronology of events is in Appendix A.
The registrant claimed the product was a broad spectrum, ready-to-use public
health disinfectant, cleaner, and food contact sanitizer. "Broad spectrum" refers
to a product that is efficacious against both gram-positive and gram-negative
bacteria. "Ready-to use" means the product does not need to be diluted or mixed.
The company said the product is primarily intended for general use in hospitals on
hard, nonporous, inanimate objects and surfaces. This would include non-critical
medical devices, surgical tables, and anesthesia machines in patient care areas.
The product reviewed was in liquid form.
EPA conducts post registration testing only of active ingredients of some products
with hospital and tuberculocidal claims. The registrant-reported composition of
the inert ingredient component of the product was not confirmed because EPA
does not verify the composition of ingredients listed as inert. Thus, EPA tests
confirmed only the presence and percentage of active ingredients in the product,
not the composition of inert ingredients.
OPP-AD, within EPA's Office of Prevention, Pesticides, and Toxic Substances, is
responsible for all regulatory activities associated with antimicrobial pesticides.
This includes product registrations. Within OPP-AD:
•	The Product Science Branch (PSB) conducts acute toxicology, efficacy,
and product chemistry data reviews of antimicrobial pesticides, and
identifies any data deficiencies that should be resolved by the Regulatory
Management Branches prior to registration approval.
•	The Regulatory Management Branch I is responsible for registering
some antimicrobial products, outreach and communication efforts, and
requesting post registration product testing.
•	The Regulatory Management Branch II (RMB II) is also responsible
for registering antimicrobial products, including ones with the active
ingredients in the subject product, as well as re-registration. It approves or
denies approval for all original products and can override others'
objections to the registration.
Scope and Methodology
We performed our review in accordance with Government Auditing Standards,
issued by the Comptroller General of the United States. We conducted the review
from August 8, 2005, to September 28, 2006. We performed most of our work at
OPP-AD in Washington, DC. We also visited the OPP Microbiology and
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Analytical Chemistry Laboratory Offices, Environmental Science Center, Fort
Meade, Maryland.
For all three objectives, we reviewed the product's official records (the "jacket")
from the 2004 registration application to the present, and reviewed other pertinent
documents. We also reviewed applicable laws, regulations, policy, and guidance.
We obtained information primarily from OPP and EPA's Intranet site. We
interviewed OPP-AD staff members from RMB II and PSB who were involved in
the registration. We interviewed EPA Fort Meade laboratory scientists to discuss
the scientific evaluation of the product health claims and product chemistry
analysis. We observed a demonstration of how the laboratory evaluated the
product health claims. Throughout the review we met with OPP-AD managers to
discuss the status of our work and obtain feedback.
For Objective 2, we interviewed the current and former OPP-AD associate
director, its current director, RMB II and PSB branch chiefs, the former RMB II
branch chief, and the OPP ombudsman. For Objective 3, we analyzed scientific
data, and reviewed PSB's assessment of the data from scientific studies to
determine whether the conclusions drawn by the registrant or its contract
laboratories were scientifically sound.
We interviewed the Office of Enforcement and Compliance Assurance official
who reviewed the Fort Meade laboratory test results and referred the case to the
appropriate EPA region for enforcement action. We also contacted the
regional enforcement case officer to obtain the current status of the case.
Our review of management controls and compliance was limited to those related
to the registration process for the subject product. However, written internal
controls were inadequate due to a general lack of written procedures. We
obtained Office of Prevention, Pesticides, and Toxic Substances Fiscal Years
2004 and 2005 Federal Managers' Financial Integrity Act assurance letters.
These letters did not identify any old or new management control weaknesses or
management challenges. However, OPP-AD officials were unaware of their role
in the preparation of the assurance letters. They could not provide us with their
branch or divisional level input toward the final assurance letters. Thus, we could
not draw any conclusions regarding the absence of reported weaknesses in the
assurance letters.
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Prior Audit Coverage
In 1990, the Government Accountability Office (GAO) issued a report,
EPA Lacks Assurance Disinfectants Work (GAO/RCED-90-139). The report
noted that EPA lacked sufficient internal controls to ensure the quality and
integrity of the disinfectant efficacy data that registrants submitted. It also noted
registrants submitted selective data to EPA, and EPA lacked an enforcement
strategy to ensure that marketed disinfectants worked as claimed. According to
EPA officials, they have generally implemented GAO's recommendations. We
did not verify EPA's claims because it was not within the objectives of our
review.
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Chapter 2
Lack of Procedures Led to Registration
Not Being Processed Properly
OPP-AD did not properly process registration for the antimicrobial pesticide that
was the subject of our review, and failed to recognize a new active ingredient in a
hospital disinfectant and sanitizer product. Also, OPP-AD did not address
concerns regarding the effectiveness of the product. Specifically:
•	OPP-AD did not properly recognize that the product contained a new
active ingredient. As a result, EPA did not bill the registrant the fee for
products with a new active ingredient. For this particular product, the fee
would have been $50,000.
•	Former OPP-AD branch managers did not address all staff concerns
regarding product registration. Several staff consistently indicated that a
former manager exerted verbal pressure for them to approve the product,
contributing to a working environment of distrust and confusion.
•	OPP-AD branch managers did not resolve all science reviewers' concerns
regarding product approval.
The deficiencies generally occurred due to a failure to identify a new active
ingredient and a general lack of procedures regarding handling registrations.
Throughout our review, a lack of documentation made it difficult for us to
identify the rationale for decisions made. Post-registration testing demonstrated
problems regarding the effectiveness of the product. At EPA's request, the
registrant voluntarily withdrew the product from the marketplace.
Misclassifying Active Ingredient Status May Have Resulted in
Lost Fees
OPP-AD staff and managers indicated they did not assess or collect the
registration fee required for products containing a new active ingredient. Based
on the applicable fee schedule and other factors, the fee would have been $50,000.
OPP-AD did not recognize that the product contained a new active ingredient.
New Active Ingredient Not Designated as Such
The current RMB II branch chief believed that the active ingredient "X" in the
product was not treated as a new active ingredient because the ingredient had
been identified as an active ingredient in a previously registered product.
However, that product's registration was canceled and thus no longer registered.
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OPP-AD's current management team agrees that this product should have been
processed as containing a new active ingredient. The current RMB II branch chief
said he initially believed once a chemical was an active ingredient in a registered
product it cannot again become a new active ingredient, even if the prior product's
registration is canceled. However, he agreed that based on additional OPP
clarification, the product should have been considered as having a new active
ingredient. Other OPP-AD managers agreed. In an email, the current branch chief
also noted that in hindsight it would appear that this should have been treated as a
new active ingredient procedurally given that there were no currently registered
products with active ingredient "X" listed as an active ingredient when the
application was received.
Further, there were inadequate procedures to determine when a product with an
active ingredient has been canceled. Without adequate procedures, confusion
resulted. The OPP-AD division director said that the PSB chemist should have
identified that there was a new active ingredient through his review of the Product
Code related to the canceled registration. However, the director also said that
product coding in the database does not distinguish between current and canceled
registrations. Consequently, staff may not have been aware the prior product was
canceled. The PSB chemist indicated he should have caught the classification
mistake. RMB II staff believed the former RMB II manager was responsible for
the mistake because that person had agreed during the pre-regi strati on meeting to
register the product without a new active ingredient designation.
In addition to costing the registrant the $50,000 fee, the designation of a new
active ingredient could have taken up to 1.5 years to register. OPP-AD staff noted
that most products are registered in less than a year.
Key Decision Documents Not Available
The official record did not contain key decision documents. The record contained
no documentation regarding the new active ingredient determination. It did not
contain a record of key meetings, such as the pre-regi strati on meeting. It did not
contain documentation of how and why the former RMB II manager overrode
staff objections about the way the product was registered. As a result, staff and
managers had differing recollections of how the product was registered without a
new active ingredient designation.
OPP-AD's written guidance notes that within 30 days after the pre-application
meeting, OPP-AD is to provide a set of minutes. The minutes are to describe the
matters discussed, any commitments made, and any conclusions reached. Staff
involved in the meeting should concur with the contents of the meeting record
prior to its issuance to the company. Both the OPP-AD associate director and
PSB team leader said it is important to record and keep an EPA-approved copy of
the pre-registration meeting in the official file, referred to as the "jacket."
However, both acknowledged this is not consistently followed. The OPP-AD
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associate director noted that if such records were kept, the misunderstandings and
controversies regarding the pre-registration meeting discussion and the registrant
agent's claim regarding this product could have been avoided.
Pre-registration meetings should not be used to make decisions such as the
acceptability of test data. The purpose is clearly to ensure that all forms, data, and
other relevant information needed for a new registration are contained in the
package. Application package content is a primary function of these meetings. In
his response to our draft, the OPP director noted that pre-application meeting
guidance is posted on its Website and that application content is a primary focus
of those meetings.
Because the jacket did not contain all documentation critical to the registration
decision, we relied on staff and managers to describe the circumstances
surrounding the misclassification of the product. As OPP's director noted in the
response to our draft report, the jacket is not intended to contain all documents
related to the registration, such as the actual laboratory studies.
OPP-AD Did Not Appear to Address Staff Concerns
OPP-AD managers did not have written procedures to determine whether there
were staff concerns regarding a product registration approval, or to address or
document those concerns. OPP-AD managers and staff could not describe how
staff concerns should be resolved, nor provide detailed procedures on the
resolution process. As a result, staff and management had differing opinions
about duties and responsibilities. Staff made verbal statements indicating their
manager exerted verbal pressure to approve registration of the product reviewed.
However, due to the lack of documentation, neither we nor staff could find
evidence that this occurred. While we do not intend to imply that this one case is
indicative of the division in general, it is a serious and continuing concern among
staff and should be addressed by OPP-AD management. OPP commented that it
does have established procedures to resolve staff concerns and will again
disseminate them to all staff and managers.
Staff told us the product was registered against their verbal objections regarding
the new active ingredient issue and unresolved science deficiencies. Although
their concerns were not documented, they unanimously and consistently told us
they had informed the former RMB II branch chief about these matters.
The primary RMB II product reviewer for active ingredient "X" said he told the
former RMB II chief that he believed the product contained a new active
ingredient and that the product chemistry report deficiencies should be resolved
prior to approval. He said he felt so strongly that he refused to sign the
registration approval form. Rather than addressing his objections, the branch
chief instructed another staff member to prepare and approve the registration
form. Although the product took 3 months longer than the division's 4-month
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goal, the product reviewer said he believed the former RMB II branch chief and
OPP-AD divisional director pressured him to approve the product because they
had promised the registrant a "quick" registration. The former branch chief
acknowledged that the new active ingredient registration takes much longer than
the registration of a product with "old active." However, the division director and
former branch chief denied these allegations and said they did not recall the staff
raising concerns.
The RMB II product manager who approved the registration also stated she had
product chemistry concerns. However, she said she was new at the time and did
not feel she should hold up the product's approval. Further, she noted she was a
microbiologist, while the branch chief was a chemist and the unresolved issues
were primarily chemistry-related. However, she said employees reluctantly
performed tasks because they "did not want to be in trouble." She said she and
other staff approved the registration "because the branch chief told them to do it."
A third product reviewer said she was glad her involvement with the registration
of this product was minimal. She said that the registrant's agent was putting an
"extreme amount of pressure on the staff' to get the product approved "within the
promised timeframe." This product reviewer declined to be involved with the
registration or sign the approval letter. She was able to convince the former
branch chief to not give her further responsibilities related to this product, noting
she feared approving the product "would come back to haunt her."
We discussed the staff concerns issue with the current OPP-AD associate director
and RMB II branch chief. The associate director told us that OPP-AD began
evaluating the division's working environment in May 2006. The associate
director also said the Division initiated team building exercises. Both the
associate director and branch chief expressed their willingness to continue taking
measures to prevent reoccurrence of similar situations in the future.
Not All Science Review Deficiencies Resolved
OPP-AD procedures did not require PSB scientists to conduct product reviews
and analyses that would help them determine whether registrants' conclusions
were scientifically sound. Although OPP stated that critical analysis is the
essence of a PSB reviewer's job, the PSB scientists did not agree. Questionable
data and conclusions also went unnoticed during supervisory reviews. OPP noted
that, because this was a routine package, managers would likely not get involved
in the product science review. We agree that manager involvement in routine
cases may not be necessary. However, in this case, a brief management review
may have provided the vehicle for staff to have their concerns heard.
Some of these data clearly questioned the efficacy of the product (the product's
ability to produce the desired effect). PSB scientists and their team leader told us
their job did not require them to critically analyze data or question the data.
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OPP's response noted that when the registrant resubmitted sanitizer claim test
results that concluded the product was efficacious, the sanitizer claim had to be
accepted. Others raised questions about product chemistry and its storage
stability. Because neither the registrant's filing nor its jacket at OPP-AD
contained all required data, we could not definitively determine why the process
failed.
Although staff raised concerns about certain deficiencies in the registrant-
submitted data, they failed to recognize other noticeable inconsistencies that were
indicators of potential problems. Procedures do not require that the PSB manager
and team leader ensure that staff critically review registrants' data. In some cases,
the unidentified inconsistencies were more significant than the concerns the PSB
staff raised. For example, data submitted by the registrant for its sanitizer claim
showed that the contact time needed to pass the sanitizing test was longer than
contact time necessary to pass the tuberculocidal test - the opposite of what you
would expect because the tuberculosis bacteria are more difficult to kill than most
other species of bacteria.
Also, the registrant submitted required data from efficacy and toxicity studies, but
did not submit all required product chemistry data. Because the subject product
was produced by an integrated system, the registrant was required to submit all
product chemistry data, including data on water solubility, vapor pressure, and
octanol/water coefficient. Certain chemical and physical characteristics of the
product (e.g., color, odor, physical state) are needed for EPA to respond to
emergency requests for identification of unlabeled pesticides involved in
accidents and spills or implicated in poisoning episodes. Data on stability,
oxidation/reduction potential, flammability, explodability, storage stability,
corrosion characteristics, and dielectric breakdown voltage are used for hazard
assessment.
Initial product chemistry reviews, conducted by the PSB chemist, found some
data unacceptable because the data did not meet regulations or EPA guidelines, or
were not addressed in the application submission. Prior to registration, the
registrant clarified certain issues raised, and requested waivers for others.
However, the jacket did not contain all records of decisions reached regarding
waiver requests, nor could OPP-AD staff or management provide copies of the
waiver approvals. Management believed these unresolved deficiencies did not
affect OPP-AD's ability to make a decision about registering the product.
Nonetheless, documentation on the final disposition of the waiver requests is
needed to support decisions and provide for transparency.
During post-registration testing, the Fort Meade laboratory does not typically, nor
in this case was it asked to, analyze a sample of the product reviewed to determine
all its specific ingredients. Therefore, we could not determine whether the inert
ingredients listed on the label were complete and accurate.
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Distributor Products Were Subsequently Registered
In January 2006, EPA laboratory tests determined that the product was ineffective
against Staphylococcus aureus and Pseudomonas aeruginosa and, therefore, EPA
could not substantiate its health claims. OPP-AD's PSB prepared the required
official memo to the EPA Office of Enforcement and Compliance Assurance for
taking enforcement action to have the product withdrawn from the marketplace.
However, in April 2006, 10 weeks after the product was determined ineffective
and 7 weeks after OPP-AD's PSB prepared the official memo, another OPP
division - the Information Technology and Resources Management Division -
approved the registration of three products manufactured by the same company
with the same ingredients but distributed under different names by a different
company.
EPA asked the registrant to voluntarily withdraw the original and all distributor
products from the marketplace. After being informed by EPA of the failing
laboratory evaluations, the registrant asked the distributor product company to
stop distributing the products.
Upon receiving the distributor product registration application, EPA does not
currently check the status of the original product for any pending adverse actions.
The OPP-AD manager agreed that the problem was the timing of the various
actions. He also acknowledged that those who register distributor products had
no way of knowing that there was an imminent action and would not know there
was a pending action unless they routinely checked with the Office of
Enforcement and Compliance Assurance. He stated that improving the distributor
product registration process could help prevent distributing products that are not
effective.
Post-Registration Efficacy Test Results Show Problems
OPP-AD accepts registrants' submitted label claims that are supported by
appropriate data and does not conduct its own pre-regi strati on efficacy testing.
Further, OPP-AD does not currently have the statutory authority to conduct pre-
registration testing itself. Post-registration hospital disinfectant and antimicrobial
test results available to us showed a 40-percent failure rate for tuberculocidal
product tests (25 failures out of 62 tests). It also showed a 29.5-percent failure
rate for hospital disinfectant tests (76 failures out of 259 tests). EPA does not
have a mechanism to track and determine the root cause of such failures.
In a 1990 GAO report, EPA Lacks Assurance Disinfectants Work (GAO/RCED-
90-139), GAO noted that EPA lacked sufficient internal controls to ensure the
quality and integrity of the disinfectant efficacy data that registrants submitted.
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The current OPP-AD associate director acknowledged that this is a key issue and
improvements are still needed in this area. We believe that fully implementing
our recommendations should help reduce the rate of post-registration efficacy
failures.
Conclusions
OPP-AD did not have written, detailed procedures to guide the antimicrobial
pesticide registration process. Because staff and managers did not correctly
identify whether the product reviewed contained a new active ingredient, EPA did
not bill the registrant the $50,000 registration fee. Also, staff and managers are
unclear about how to resolve staff concerns about registration deficiencies.
Product science branch reviewers disagreed with their managers about their duties
and, as a result, did not critically review and analyze key product data. The
registrant's jacket did not contain key decision documents. OPP-AD's lack of
procedures resulted in confusion among the staff and different perceptions
regarding responsibilities between the staff and management. Uncertainty about
responsibilities and authority created an environment of distrust and confusion
within OPP-AD. Current management believes this environment has improved
and management is committed to resolving any remaining issues.
Recommendations
We recommend that the Director, Office of Pesticide Programs:
2-1 Establish procedures to:
•	Correctly identify the status of each active ingredient to ensure that an
ingredient previously recognized as active is not part of a product for
which registration was subsequently canceled.
•	Assign responsibilities and authority to identify new active ingredients and
prepare detailed workflow instructions to process registration applications.
•	Determine the necessity of meeting with registrants and their agents, and
document the purpose and outcome of all such meetings.
•	Resolve and document discrepancies between staff concerns and
management decisions related to product registration.
•	Encourage all staff to critically review registrant-submitted data to ensure
data are scientifically sound and raise appropriate concerns about the
product's chemical composition, toxicity, and efficacy.
•	Ensure that the approval or disapproval of waivers and resolution of all
data deficiencies are documented in the jacket.
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•	Prevent distributor product registrations when the original product is under
consideration for enforcement action. Require staff to timely share failing
post-registration test results with appropriate divisions responsible for
reviewing distributor product registration applications and granting
approval.
•	Document the resolution of all data deficiencies.
•	Determine and assess registrant fees.
2-2 Determine whether OPP-AD employees still have concerns about their
working environment and, if so, work to resolve staff issues. In the interim,
continue divisional and/or branch team building exercises that would include
clarification of roles and responsibilities and management expectations.
2-3 Perform a detailed root cause analysis of antimicrobial pesticides similar to
the subject product that failed post-registration testing, and identify
appropriate actions to minimize the registration of failing products. Such steps
could include developing a pre-registration, sample check program, or similar
effort that would provide the added assurance.
Agency Comments and OIG Evaluation
EPA generally agreed with our conclusions and recommendations and stated that
in many cases it has begun taking, or completed, actions to correct issues that we
identified. EPA made detailed comments on our draft report and, where
appropriate, we made revisions. EPA's complete response is in Appendix B. We
redacted one line in EPA's response because it may contain Confidential Business
Information.
OPP agreed that the product should have been processed as a new active
ingredient and the registrant should have been billed a registration fee. It has
taken steps to more consistently document pre-registration meeting results, posted
pre-application meeting guidance on its Website, and noted that it makes every
effort to ensure its files properly document Agency decisions.
OPP agreed to remind staff about procedures to address staff concerns about
registration issues. OPP did not agree that the one registration we reviewed was
indicative of larger management issues. We do not intend to imply that this one
registration should be viewed as an indictment of the entire Antimicrobials
Division. We do note that other staff and managers were unsure about how to
resolve scientific differences and did not share the same opinion about their duties
and responsibilities. OPP's willingness to refresh staff understanding about their
duties and how to resolve differences should help alleviate confusion.
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Science reviewers consistently told us that, in part because they are not present
during testing, they did not believe they were in a position to question a
registrant's pre-regi strati on test results. Science reviewers stated that if the
registrant submits all required data and that data supports the product claims, it is
not up to EPA science reviewers to question the validity of the data. We disagree
and noted several examples that should have caused EPA reviewers to question
the efficacy of the product that was the subject of this review. For example,
reviewing the data the registrant submitted, we found the tuberculocidal contact
time relative to the sanitizing contact time to be inconsistent with expectations.
We believe OPP staff should have questioned the registrant about these contact
time claims and/or required the registrant to conduct more tests before registering
the product.
We removed the recommendation to collect the registration fee because OPP
noted that it does not have legal authority to collect back registration fees. We
added language to recommendation 2-1 for OPP-AD to add procedures for
accurately identifying and assessing registrant fees.
We do believe that there is merit in analyzing staff attitudes and the general
working environment. Although OPP correctly notes that this was one incident,
involving a manager who no longer works for EPA, current staff told us they were
reluctant to raise concerns and are confused about their duties and responsibilities.
We believe it is important that current Antimicrobials Division leadership
demonstrates its willingness to move forward from the past and work with staff to
correct any confusion and mistrust that staff may harbor.
We clarified our statement on page 10 regarding pre-registration testing
requirements. We noted that OPP does not conduct in house pre-registration tests.
We added language to recommendation 2-4 encouraging OPP to pursue a sample
check program, or similar effort, in an attempt to improve product efficacy test
results.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec.
No.
Page
No.
Subject
Status1
Planned
Completion
Action Official	Date
Claimed
Amount
Agreed To
Amount
2-1 11 Establish procedures to:
•	Correctly identify the status of each active
ingredient to ensure that an ingredient previously
recognized as active is not part of a product for
which registration was subsequently canceled.
•	Assign responsibilities and authority to identify new
active ingredients and prepare detailed workflow
instructions to process registration applications.
•	Determine the necessity of meeting with registrants
and their agents, and document the purpose and
outcome of all such meetings.
•	Resolve and document discrepancies between staff
concerns and management decisions related to
product registration.
•	Encourage all staff to critically review registrant-
submitted data to ensure data are scientifically
sound and raise appropriate concerns about the
product's chemical composition, toxicity, and
efficacy.
•	Ensure that the approval or disapproval of waivers
and resolution of all data deficiencies are
documented in the jacket.
•	Prevent distributor product registrations when the
original product is under consideration for
enforcement action. Require staff to timely share
failing post-registration test results with appropriate
divisions responsible for reviewing distributor
product registration applications and granting
approval.
•	Document the resolution of all data deficiencies.
•	Determine and assess registrant fees.
2-2 12 Determine whether OPP-AD employees still have
concerns about their working environment and, if so, work
to resolve staff issues. In the interim, continue divisional
and/or branch team building exercises that would include
clarification of roles and responsibilities and management
expectations.
2_3 12 Perform a detailed root cause analysis of antimicrobial
pesticides similar to the subject product that failed post-
registration testing, and identify appropriate actions to
minimize the registration of failing products. Such steps
could include developing a pre-registration, sample check
program, or similar effort that would provide the added
assurance.
Director, Office of
Pesticides Program
$50,000
Director, Office of
Pesticides Program
Director, Office of
Pesticides Program
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
Chronology of Product Registration
January 2004
February 19, 2004
March 17, 2004
March 22, 2004
March 23, 2004
June 23, 2004
July 7, 2004
July 15, 2004
July 20, 2004
July 2004
July 21, 2004
August 11, 2004
October 21, 2004
Action
New Law Signed: The Pesticide Registration Improvement Act was signed
by the President, providing more specifics on implementing the Federal
Insecticide, Fungicide, and Rodenticide Act. The President's approval
triggered a 60-day implementation period for EPA prior to the March 23,
2004, implementation, under which EPA took a number of steps to implement
the new Act.
Pre-Registration Meeting Held: The registrant's agent met with former
RMB II branch chief and other OPP-AD staff to propose registering product.
Federal Register Notice Issued: EPA published Federal Register notice
related to fees and timeframes. According to fee schedule, registrant would
have been billed a $50,000 fee if product had a new active ingredient.
Application Submitted to Agency: The registrant submitted application.
The registrant's package claimed OPP-AD agreed the product qualified for a
120-day review and active ingredient "X" would not be considered a new
active ingredient.
New Law Effective: The Pesticide Registration Improvement Act goes into
effect.
OPP-AD Letter Sent to Registrant's Agent: The letter indicates that the
registrant's application was deficient, noting acute toxicity data were
incomplete.
Agency Product Chemistry Review Performed: Reviews found the
concentration of listed actives on the registrant's confidential statement of
formula consistent with the label and that all ingredients in the formulation
were acceptable for use.
Additional Data Submitted Via Email: The registrant's agent submitted
additional efficacy data for sanitizing claims requested by an OPP-AD
scientist.
OPP-AD Letter Sent to Registrant's Agent: EPA informed the registrant
that the application was further deficient because efficacy and product
chemistry data did not support the product's use. The letter also suggested
label revisions.
Some Requirements Waived: PSB staff told us that they waived some data
requirements forflammability, explodability, and dielectric voltage breakdown,
but denied waivers for data requirements of stability, melting point, boiling
point, dissociation constant, ocanol/water partition coefficient, water solubility,
and vapor pressure. We were unable to verify staff statements because the
files did not contain documentation of their decisions.
Additional Data Submitted: The registrant submitted additional efficacy
data.
Agent Response Submitted: The registrant's agent responded to EPA's
July 20 letter addressing deficiencies, and stated the letter appeared to
contradict agreements in the February 19 pre-registration meeting.
Conditional Registration Granted: OPP-AD granted conditional
registration.
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I Date
Action
December 28, 2004
Amendment Accepted: OPP-AD accepted an amendment to the
registration with conditions - (1) submitting storage stability study by
March 31, 2006, and (2) submitting eye and dermal acute toxicity studies.
January 13, 2005, and
January 18, 2005
Old Active Validation Requested: The registrant's agent requested
confirmation that the active ingredient - active ingredient "X" - was not
considered a new active ingredient. The request resulted from "a few States"
asserting that the ingredient is a new active ingredient.
January 24, 2005
Letter to OPP-AD Submitted: The registrant's agent submitted toxicity
studies/amendments required by the December 28, 2004, letter.
January 2005
Branch Chief Leaves EPA: The RMB II branch chief at that time left EPA to
work for a private company.
June 23, 2005
Letter Regarding New Active Ingredient Sent: OPP-AD sent letter to
registrant's agent in response to request for confirmation that active
ingredient "X" was not a new active ingredient. OPP-AD replied that it had
concerns with the accuracy of the listed ingredient declared on the product
label.
June 27, 2005
Amendments Conditionally Accepted: OPP-AD conditionally accepted
amendments based on January 24, 2005, toxicity data.
July 28, 2005
Amendment Application Received: The registrant added a new organism
and new enforcement analytical method to the label.
September 2005
Samples Collected: OPP-AD requested that EPA's Fort Meade laboratory
collect samples for efficacy and chemical formulation analysis tests.
January - April 2006
Laboratory Results Provided: EPA received laboratory results from Fort
Meade.
February 16, 2006
Enforcement Memo Prepared: PSB prepared an enforcement referral
memo to EPA Office of Enforcement and Compliance Assurance.
April 6, 2006
Distributor Product Registrations Approved: Another OPP division
granted conditional registration to three distributor products from another
company. These products contain the same active and inert ingredients as
the product reviewed, but are marketed by another company under different
trade names. OPP approves distributor product registration without any
evaluation of the status of the original product.
July 5, 2006
Enforcement Memo Transmitted: PSB sent the February 16, 2006, memo
to the EPA Office of Enforcement and Compliance Assurance, which was
received by that office on July 10.
July 31, 2006
Voluntary Withdrawal Requested: EPA Region 9 sent a letter to the
registrant requesting voluntary withdrawal of the product in our review.
August 7, 2006
Show Cause Letter Issued: EPA Region 9 sent a "show cause" letter to the
registrant.
August 28, 2006
Laboratory Data Requested by Registrant: The registrant's attorney
responded to EPA's August 7 "show cause" letter requesting laboratory
results. The letter stated the registrant remains committed to working
cooperatively with EPA staff to resolve the matter. The letter stated the
company is not distributing the product for commercial purposes so EPA did
not need to issue a Stop, Sale, Use or Removal Order.
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Appendix B
Agency Response to OIG Draft Report
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: OPPTS Comments on the Draft Public Liaison Report:
EPA Did Not Properly Process Hospital Disinfectant and Sanitizer Registration
This memorandum responds to your request for review and comment on the draft report prepared
by the Office of the Inspector General which evaluates a Hotline compliant that the Office of
Pesticide Programs, Antimicrobials Division did not properly process a registration application
for a hospital disinfectant and sanitizer product.
In reviewing the document, it is clear that your staff have done an exceptional job of
understanding our registration program under the Federal Insecticide, Fungicide and Rodenticide
Act and its most recent amendment, the Pesticide Registration Improvement Act (PRIA) which
was enacted in 2003. While no one looks forward to being under the scrutiny of an IG
investigation, your staff conducted themselves with a high degree of professionalism and
sensitivity that I believe contributed to the overall effectiveness of the investigative process.
In general my staff agree with the findings but are concerned that an isolated incident is being
used largely to indict an entire Division. I share this concern and encourage your staff to
strongly consider this issue as they finalize the report. Detailed comments are provided below.
FROM: James J. Jones, Director
Office of Pesticide Programs
TO:
Paul D. McKechnie
Director for Public Liaison
Office of the Inspector General
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Finding #1
•	OPP agrees that the subject application should have been processed as a new active
ingredient.
•	The correct fee amount at the time of this application for this action would have been
$50,000. This was the fee associated with a new active ingredient falling into the A42
fee category, which covers non-food, indoor use as described in FIFRA Section 2(mm).
•	It would be more accurate to say that a fee of $50K would have been billed or assessed to
the registrant. PRIA includes a provision for small business waivers of fees. The
registrant in this case would likely have applied for such a waiver, which would have
then been evaluated by the Agency. It is likely the company would have met the waiver
criteria.
•	PRIA did not change the definition of a new active ingredient. OPP provided additional
clarification on the website as to how to interpret the fee categories listed in PRIA. It was
at that time that the additional phrase "currently registered products" was added to
articulate OPP's long-standing policy on new active ingredients.
•	Page 5, Paragraph 2: This discussion could be simplified to make the point that the
current management team agrees that the product should have been handled and
processed as a new active ingredient.
•	An A42 has a 540 day completion requirement under FIFRA Section 3(h), so it is more
accurate to say that had the chemical been designated as a new active ingredient, it could
have taken up to 540 days to complete the action. It should also be noted that given the
nature of (redacted), and what is understood about that chemical, it is unlikely that a large
database would have been required, which would also have shortened the potential
review time needed.
•	Page 5, Paragraph 5: Reference to "managers" is inappropriate since, based on our
understanding of the investigation, only one manager was involved in that decision, the
former Chief of RMB2 (Regulatory Management Branch 2).
•	Guidance on pre-application meetings has been posted on the Agency website at
http://www.epa.gov/oppad001/preapplmeet010.htm for a number of years. The purpose
is to ensure that all forms, data, and other relevant information needed for a new
registration are discussed. Application content is a primary focus of these meetings.
•	OPP agrees that the implementation of Division guidance regarding the documentation of
pre-regi strati on meetings must be applied consistently. AD has taken steps to place
renewed emphasis on this policy by re-issuing the policy and having follow-on
discussions with staff in Branch and PRIA meetings about the importance of timely
documentation of pre-registration meetings.
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•	OPP makes every effort to ensure that all product jackets contain documents critical to
the registration of the product. It appears that documentation of the resolution of some
key issues around this application was not developed or was not included in the file
jacket (e.g., waiver determinations). Jackets do not normally include the actual studies
themselves or, in many cases, reviews of studies since there are other document
management systems in place to store those types of records. The jacket system is not
designed to house all documents pertaining to a particular registration.
Finding #2
•	There are established procedures within OPP to address the concerns of staff that hold a
dissenting opinion on a give matter. Current AD management is aware of these
procedures which describe how staff concerns should be resolved. Staff should also be
aware of this policy since it was disseminated throughout OPP. Nevertheless, we will
again provide staff with the policy.
•	This finding is based on conflicting recollections of the events surrounding this
registration action amounting to a "he said, she said" situation. The lack of
documentation of the concerns raised in the interviews greatly weakens the assertion that
OPP-AD management did not appear to address staff concerns. Further, the finding is
exceedingly broad. Even if the information provided during the interview process is
considered valid, this would have to be considered an isolated incident involving one
manager who no longer is employed by the Agency. Therefore, the finding, if retained,
should be very specific to pertaining to an isolated event in the past. Further, inference
should not be made that there is a "working environment of distrust, fear and confusion".
The report is silent on the condition of the current working environment in both the
Branch and the Division, which would be more pertinent when considering
recommendations.
•	In terms of the statement regarding a "quick" registration it should be noted that the
normal time frame for the type of action that this was classified as is 120 days. However,
the action took almost 7 months to complete.
Finding # 3
•	The role of science reviewers in OPP is to provide an independent, critical analysis of
registrant submitted data in determining whether to register a product and how to label
such a product to protect human health and the environment. This is the essence of these
positions; therefore, the information presented on Page 7, Paragraph 5, appears to have
been taken out of context.
•	The PSB Team Leaders are responsible for final review and approval of all data that are
submitted to the Branch. Therefore, it is not customary or necessary for the PSB Branch
Chief to engage in the final review process. However, the Branch Chief is involved in
the review process when it involves a new technology or submission that requires
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management oversight. Since this was a routine application, the PSB Branch Chief did
not review the data or conclusions made by the science staff.
•	Efficacy concerns over sanitizer claims were sent to the company indicating that all
sanitizer claims had to be removed. The registrant later submitted efficacy data to satisfy
the sanitizer claim for which an acceptable review is in the product registration file.
•	In reference to the chemistry and efficacy data submitted to support the application,
mention is made of OPP staff failing to "recognize other notable inconsistencies that
were indicators of potential problems". OPP has not received the analysis that was used
by the IG to come to this conclusion, so it is not possible to comment on the accuracy of
this statement.
Recommendations:
OPP agrees with bullets 1-8.
2-2
PRIA does not include provisions for charging a registrant a fee after a registration action has
been completed. OPP is not aware of any process or procedure for legally billing a registrant in
a case like this. Therefore, OPP does not believe it has the legal authority to implement this
recommendation. Further, the term "collect" is not appropriate. OPP issues an invoice to
registrants, who either pay the fee or request a waiver. Therefore, the appropriate language
would be to "Issue an invoice... " Based on our limited knowledge of the company, we believe
that, if a large fee were invoiced to this company, it is likely that they would seek and receive a
fee wavier. Also, the correct fee amount at the time of this application for this action would have
been $50,000. This was the fee associated with a new active ingredient falling into the A42 fee
category which covers non-food use, indoor uses as described in FIFRA Section 2(mm).
2-3
OPP disagrees with this recommendation. The finding that relates to this recommendation is
based on conflicting recollections of the events surrounding this registration action amounting to
a "he said, she said" situation. The lack of documentation of the concerns raised in the
interviews greatly weakens the assertion that OPP-AD management did not appear to address
staff concerns. Further, the finding is exceedingly broad. Even if the information provided
during the interview process were considered valid, this would have to be considered an isolated
incident involving one manager who no longer is employed by the Agency. Therefore, the
finding, if retained, should very specifically pertain to an isolated event in the past, and the
inference should not be made that there is a "working environment of distrust, fear and
confusion". The report is silent on the condition of the current working environment both in the
Branch and the Division which would be more pertinent when considering recommendations.
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2-4
OPP-AD is gathering data towards understanding the possible causes for antimicrobial products
passing the efficacy requirements at the time of initial registration, but failing the same
requirement during the post registration testing program. Based on the database, we will
evaluate the active ingredients used to formulate the products, possible anomalies in the manner
in which the products were tested for registration versus post-registration testing, and other
issues that have been brought to AD's attention regarding the test methods. In addition, due to
the documented problems with repeatability and reproducibility within the qualitative Use-
Dilution test methods, AD is working in conjunction with the Organization for Economic
Cooperation and Development (OECD) to validate and adopt a quantitative test method for hard
surface disinfectants.
2-5
On page 9, the report states "OPP-AD does not currently have the statutory authority to require
pre-regi strati on testing." This statement is not accurate. OPP does require the applicant for
registration to conduct pre-registration testing, and our evaluations are based, in part, on the
resulting data. However, OPP-AD plans to investigate the feasibility of a sample check program
for select hospital disinfectants. This may reduce the number of products that ultimately fail the
post-registration surveillance. OPP-AD believes the remaining recommendations from the
GAO's 1990 report, EPA Lacks Assurance Disinfectants Work (GAO/RCED-90-139) have been
implemented, as outlined in the July 6, 2006, memo (see attachment).
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Attachment
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
July 7, 2006
MEMORANDUM
Subject: GAO Report Recommendations
GAO/RCED-90-139
From:	S/Michele E. Wingfield, Chief
Product Science Branch
Antimicrobials Division (7510C)
To:	Tapati Bhattacharyya, Project Manager
Office of Congressional and Public Liaison (OCPL) (3 AI00)
The Antimicrobials Division, Office of Pesticide Programs, provides the following response to
your request for an update on the recommendations made by the Government Accounting Office
(GAO) in their 1990 report entitled, "Disinfectants, EPA Lacks Assurance They Work." Please
feel free to contact me if you have any additional questions.
Recommendation # 1:
To increase the degree of certainty that disinfectant efficacy test methods and standards
are valid, we recommend that the Administrator, EPA, develop a detailed plan, including
cost estimates and milestones, to resolve the controversies surrounding existing methods
and standards. The plan should include a research strategy that addresses problems with
the alleged variability in test methods, adequacy of lab tests to simulate actual use, and the
validity of performance standards, as discussed in this chapter.
Response: Test Methodology Development
The Agency has had a guidance strategy in place since 1987 outlining the need for investigation
of the test methods used to support efficacy claims of antimicrobial products. In 1990 and 1991,
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the Agency awarded three cooperative agreements for research and development of test methods
to address sporicidal, tuberculocidal, and virucidal testing. The research for these three
cooperative agreements was completed in the late 1990s. Of the three, the sporicidal test method
was further developed into a "universal" method that could evaluate the efficacy of spores,
mycobacterium, vegetative bacteria, fungi, and viruses. This new method has a quantitative
performance (based on log reduction) rather than the previous qualitative (presence/absence)
standard that is used for the existing AO AC test methods. As a part of international
harmonization efforts, in 2002, the Agency hosted an Organization for Economic Cooperation
and Development (OECD) workshop to begin discussions on harmonizing test methods for
public health antimicrobial products. Following the workshop, a steering committee has been
working towards developing a test method specifically for hard surface disinfectants. If
approved, the data generated from this method would be acceptable in all OECD member
countries. The Antimicrobials Division has representation on the steering committee and the
Biological and Economic Analysis Division's Microbiology Laboratory will participate in the
validation of the new method. The method proposed for international validation is based upon
the "universal" method funded by EPA.
Further, we recommend that the Administrator, EPA, convene the FIFRA Scientific
Advisory Panel to assist in developing the plan and overseeing the research strategy
direction and management.
Response: Use of the FIFRA Scientific Advisory Panel to Review Test Methodology
A microbiology sub-panel of the FIFRA Scientific Advisory Panel was established in FY 91.
Members were chosen from academia and the Centers for Disease Control and Prevention. EPA
has utilized the expertise of the SAP sub-panel for guidance and review of the test methodology
research cooperative agreements and for review of an EPA policy for the acceptance of protocols
and/or method modifications which deviated from the standard accepted methods. The Agency
continues to use a SAP External Review panel for evaluating new methods for antimicrobial
pesticides. In recent years, the panel has provided recommendations for a variety of novel
technologies, including but not limited to, biofilm protocols, fruit and vegetable washes,
antimicrobials used for pathogen reduction in water in food processing plants, dental unit
waterline applications and bacteriophages.
Recommendation # 2:
In addition, we recommend that the Administrator, EPA, develop and publish a policy that
establishes specific criteria for evaluating the validity of new disinfectant efficacy test
methods and modifications to methods, including criteria for determining when
independent laboratory data, such as data from a collaborative study, are needed to
demonstrate the validity of proposed methods and modifications.
Response: Policy for Evaluating New Efficacy Test Methods and Method Modifications
In 1991, a workgroup was established to develop an EPA policy detailing the criteria and process
which should be used to accept new protocols and modifications to standard methods. By the
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end of the second quarter FY91, the workgroup had drafted a document entitled, "Systematic
Process and Criteria to Assess the Validity of EPA/Registrant/Commercial Laboratory Proposed
Test Methods and Modifications." The document was presented to the SAP microbiology sub-
panel in May 1991. The SAP approved the document, stressing the importance for scientific
review of new test methods, protocols and modifications to standard methods. In addition, the
Agency has posted on the Antimicrobials website, guidance to applicants outlining the review
process for new test protocols.
Recommendation # 3:
To improve EPA controls over the quality and integrity of registrant-submitted data, we
recommend that the Administrator, EPA, implement a pre-registration-testing program to
verify selected disinfectant efficacy data. The Administrator could target pre-registration
tests on those claims that are of the greatest public health significance and/or products with
suspected efficacy problems.
Response: Pre-registration Testing of Sterilants - Post-registration Testing of Sterilants,
Tuberculocides, and Hospital Disinfectants
Since they are the most critical to infection control, EPA initiated pre-registration testing of all
new sterilant claims. This testing was conducted by the Indiana State Chemist Laboratory
located at Purdue University. Since the August 3, 1996 Food Quality Protection Act
amendments to FIFRA, removed liquid chemical sterilants from the definition of a pesticide
(these products are now regulated by the Food and Drug Administration) this pre-registration
program is no longer in place.
The Agency also initiated a Post-registration Antimicrobial Testing Program to evaluate the
claims for sterilants, tuberculocides, and hospital disinfectants. Again, since sterilant products
are the most critical to infection control, these products were tested first. More than half of the
registered liquid chemical sterilants were removed from the marketplace by enforcement actions
because of failures in the testing program or through voluntary cancellation by the affected
registrants. With the assistance of state laboratory support from North Carolina, Ohio, and
Michigan, and the establishment of the Office of Pesticide Programs Microbiology Laboratory,
efficacy testing of tuberculocides and hospital disinfectants in ongoing. Approximately one third
of these products are failing efficacy testing, resulting in enforcement actions (cancellations,
fines), removal of label claims, and reformulation of products to bring them into regulatory
compliance.
To improve the effectiveness of the data review, lab inspection, and data audit programs,
we recommend that the Administrator, EPA:
Direct the Laboratory Data Integrity Assurance Division to identify all laboratories that
have performed efficacy studies submitted to EPA to support disinfectant registrations and
meet the division's goal of inspecting these labs at least every 2 years (at a minimum, direct
LDIAD to use the Office of Pesticide Programs Pesticide Document Management System,
which contains the best available information for identifying the labs);
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Response: The Office of Compliance Monitoring conducted a manual review of efficacy studies
submitted to the Agency of identify performing laboratories. Routine procedures have been
implemented to identify new laboratories at the time of study submission.
Direct LDIAD to establish a check sample program as part of the lab inspection program
to better assess the ability of labs to perform disinfectant efficacy tests;
Response: EPA did not establish a check sample program because the resources required for
such a program would be substantial, and the information provided would not be very useful.
Instead, the Agency assures the quality of data through inspections of laboratories performing
antimicrobial efficacy testing.
Direct the Office of Compliance Monitoring to review its internal controls for ensuring that
inspections/audits are processed on time; and
Response: OCM implemented new procedures for conducting antimicrobial lab audits and
Good Laboratory Practice inspections. In addition, a GLP Inspection Review Committee was
established to review/process inspection reports in a timely manner.
Direct the Office of Pesticide Programs and the Office of Compliance Monitoring to
develop and implement specific guidance for data reviewers, lab inspectors, and data
auditors to follow; further, direct these offices to develop, publish for comment, and
implement detailed policies and guidelines to decide what registration and/or enforcement
action to take on the basis of findings from lab inspections and data audits.
A Reference Guide/Training Manual for Conducting Efficacy Reviews is available for all
efficacy reviewers in addition to the Standard Evaluation Procedures guidance. Criteria for
rejecting studies have been established. Standard efficacy reporting templates, to be used by the
regulated community when submitting efficacy studies, have been posted on the Antimicrobials
Division's website. As stated above, OCM has established procedures for lab inspectors and
data auditors to follow when conducting inspections.
Recommendation # 4:
We recommend that the Administrator, EPA, develop, publish for comment, and
implement an enforcement strategy to ensure that the marketed disinfectants work as
claimed. This strategy should specify (1) the mechanisms and procedures for identifying
potentially ineffective disinfectants; (2) the procedures for investigating and verifying
complaints about potentially ineffective disinfectants, including, where necessary, the use of
independent laboratory testing; and (3) the criteria and procedures for initiating
registration and/or enforcement action against disinfectants found to be ineffective.
Response: The Office of Enforcement and Compliance Assurance and the Office of Pesticide
Programs has developed and implemented the Antimicrobial Testing Program (ATP), a national
program strategy which included a regulatory and enforcement strategy. This program
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addresses, among other things, the three GAO specifications (namely, procedures for identifying
potentially ineffective disinfectants, inspection/investigation procedures, and criteria for
initiating actions.)
In light of federal budget constraints, we also recommend that the Administrator explore
options for pooling resources from the states, user groups, and industry to implement a
national disinfectant efficacy enforcement strategy.
Response: During the sterilant phase of the testing program, the Agency entered into an
Interagency Agreement with FDA and cooperative agreements with the Mississippi State and
Indiana State Chemist to conduct efficacy testing for sterilant products. EPA currently has
cooperative agreements in place with state laboratories from North Carolina, Ohio, and Michigan
and in the past, Florida, to assist with testing tuberculocidal and hospital disinfectants. EPA also
has a state-of-the art research microbiology laboratory that, among other activities, conducts
efficacy testing for the ATP. In addition to efficacy testing, formulation chemistry analysis is
conducted on all products in the ATP.
Recommendation # 5:
We recommend that the Administrator, EPA, develop a detailed cost/benefit analysis of
alternatives for operating a laboratory facility to research and test the efficacy of disinfectants,
including the option of charging fees to register disinfectants to help finance such a facility, and
submit the results of its analysis to the Congress so that the Congress may weigh the advantages
and disadvantages of various alternatives.
Response: In 1996, the Office of Pesticide Programs Microbiology Laboratory was opened at
the Environmental Science Center on the grounds of Ft. Meade, Maryland. This state-of-the-art
facility also houses the EPA's Analytical Chemistry Laboratory. In addition to testing
tuberculocides and hospital disinfectants for the ATP, the OPP Microbiology Laboratory has
conducted test methodology research on sporicides and disinfectants, and aided the
Antimicrobials Division in reviewing protocols for new label claims.
In March 2003, the Pesticide Regulatory Improvement Act established fees for the registration of
pesticides, including antimicrobial products. While these fees were not used to finance the
research laboratory they are used, in part, to fund external review of data for regulatory
decisions.
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Appendix C
Distribution
Office of the Administrator
Assistant Administrator, Office of Prevention, Pesticides & Toxic Substances
Agency Followup Official
Agency Followup Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Director, Financial Management Division
Audit Followup Coordinator, Office of Prevention, Pesticides & Toxic Substanaces
Acting Inspector General
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