U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
December 15, 2010
Catalyst for Improving the Environment
Why We Did This Review
We initiated this review to
evaluate whether U.S.
Environmental Protection
Agency (EPA) systems ensure
that registered antimicrobial
pesticide products are effective
or that appropriate corrective
actions are taken when products
are found to be ineffective.
Antimicrobial pesticides are
designed to destroy or suppress
harmful bacteria, viruses, and
other microorganisms on
inanimate objects and surfaces
in hospitals and other settings.
EPA's Office of Pesticide
Programs initiated the
Antimicrobial Testing Program
(ATP) to test antimicrobial
products in response to a 1990
U.S. Government
Accountability Office report,
which concluded that EPA
lacked an enforcement strategy
to ensure that registered
disinfectants sold and
distributed worked as claimed
on product labels.
For further information,
contact our Office of
Congressional, Public Affairs
and Management at
(202) 566-2391.
To view the full report,
click on the following link:
EPA Needs to Assure Effectiveness of
Antimicrobial Pesticide Products
What We Found
ATP's design and implementation cannot provide assurance to the public that
the product label claims are valid. ATP has been testing to ensure antimicrobial
products, including hospital disinfectants and tuberculocides, meet stringent
efficacy standards. However, after nearly 19 years, over 40 percent of
registered products have not been tested. Those that have been tested have
experienced a consistently high failure rate. During our review, EPA was
requesting test sample submissions from manufacturers using a voluntary
process known as the ATP "direct shipment" initiative, adopted in December
2008. However, the process is considered insufficient for enforcement actions.
Also, EPA does not have a strategy for informing hospitals and other likely
end-users of failed test results or when enforcement actions are taken. EPA's
implementation of the ATP has not delivered on its mission. Rather than
providing increased assurance that antimicrobial products are efficacious, it
raises concerns regarding the integrity of EPA's product registration process.
Ultimately, there may be products on the market that are ineffective.
Sometimes, the response to ATP test failures is retesting, which can take years.
Meanwhile, the product may remain available for use in hospitals and the
public. Testing of samples obtained through the ATP voluntary direct shipment
initiative lacked appropriate chain of custody and therefore the results could not
be considered adequate to support an enforcement action.
What We Recommend
We recommend that EPA redesign its process to verify antimicrobial
effectiveness. The new program should have a testing program that provides
reasonable efficacy assurances for all registered tuberculocides, hospital-level
disinfectants, and registered sanitizers; and all subsequently registered
products. Also, the program should provide an efficient sampling protocol that
enables regulatory and enforcement actions as well as consistent monitoring of
enforcement actions taken by EPA regions.
The Agency agreed that the program should be redesigned, and agreed with
most of the findings of the draft report. The Agency did not agree with how we
characterized some aspects of the program as voluntary. While the Agency did
not explicitly agree with the recommendations, we found the Agency to be
responsive to our recommendations.