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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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