PRtf
U.S. Environmental Protection Agency
Office of Inspector General

At   a  Glance
                                                                                          09-P-0952
                                                                                       May 27, 2009
                                                                Catalyst for Improving the Environment
Why We Did This Review

The Office of Inspector General
(OIG) received a Hotline
complaint that alleged that EPA
is withholding information on
product failures in the
Antimicrobial Testing Program
(ATP) from intended users.

Background

The EPA's Office of Pesticide
Programs—Antimicrobials
Division (OPP-AD) is
responsible for all regulatory
activities associated with
antimicrobial pesticides. A key
project of OPP-AD is the ATP,
the post-registration testing
program designed to evaluate the
effectiveness of EPA-registered
disinfectants.  The focus of the
ATP is on disinfectants most
crucial to infection control:
sterilants, tuberculocides, and
hospital-level disinfectants.
For further information, contact
our Office of Congressional,
I Public Affairs and Management at
(202)566-2391.

To view the full report, click on the
following link:
www.epa.gov/oig/reports/2009/
20090527-09-P-0152.pdf
              Results of Hotline Complaint Review
              of EPA's Antimicrobial Testing Program
               What We Found
              We found that the allegation against EPA's ATP was unsubstantiated. The
              program policies and procedures require OPP to notify the Office of
              Enforcement and Compliance Assurance (OECA) and manufacturers when a
              product fails testing. OPP-AD is not withholding information on product
              failures from these intended users. As of February 2009, 325 of the 671 EPA
              registered disinfectant products had been tested under the ATP. ATP
              anticipates completing efficacy testing of all currently registered disinfectant
              products by 2011.

              The OPP-AD procedures specify what type of action is to be taken based on
              testing results. When a product fails, OPP-AD follows its Standard Operating
              Procedure (SOP) for product failures. OPP-AD decides whether a regulatory
              or enforcement action should be pursued for products that fail.  OECA makes
              the final decision regarding any enforcement actions to be taken against
              manufacturers.

              The report does not contain any recommendations; however, we make several
              observations regarding OPP policies and practices that could be improved.
              OPP-AD could:

                 •  provide publicly-accessible information on effective hospital
                    disinfectants and tuberculocidal products as it does with other
                    disinfectants.
                 •  amend its SOPs to include products without a hospital disinfectant label
                    claim.
                 •  develop a plan to sustain the program after testing is completed in 2011.

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