September 10, 2014
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*	 U.S. Environmental Protection Agency	14-P-0350
mm "z Office of Inspector General
At a Glance
Why We Did This Review
Our objective was to determine
to what extent the
U.S. Environmental Protection
Agency (EPA) Office of
Pollution Prevention and
Toxics' (OPPT's) Risk
Assessment Division (RAD)
uses and implements quality
management policies during
chemical risk assessments.
The goal of the quality
management system is to
provide a foundation to "ensure
that environmental data are of
sufficient quantity and quality to
support the data's intended
use." Each EPA office that
collects, evaluates and uses
environmental data is required
to develop a Quality
Management Plan. That plan
defines an organization's
quality-related policies,
procedures, roles,
responsibilities and authorities.
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
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The full report is at:
EPA's Risk Assessment Division Has Not
Fuiiy Adhered to its Quality Management Pian
What We Found
RAD has adhered to some but not all aspects of its
current Quality Management Plan. RAD has not
fully implemented key aspects of its plan related to
training, internal audits and plan revisions.
Additionally, unlike other agency offices, RAD does
not post its Quality Management Plan online as a
good business practice.
Without a robust quality
management system,
RAD risks making
environmental and
human health policy
decisions that rest on a
faulty foundation.
RAD is not ensuring managers and staff take in-house formal quality assurance
training. RAD, instead, relies on branch chiefs and project managers to informally
train staff through mentoring. OPPT is aware of the need to provide formal quality
assurance training to its staff. The Quality Assurance Manager acknowledged the
quality assurance training gap and plans to develop specific quality assurance
training. Additionally, RAD did not conduct a formal quality assurance training
needs assessment.
The RAD Quality Assurance Coordinator has not conducted internal audits of
quality assurance programs. Moreover, RAD has not revised its Quality
Assurance Annual Report and Work Plan or Quality Management Plan when
changes occurred to its program activities that involve major risk assessment
responsibilities. Lastly, RAD does not post its Quality Management Plan on its
Intranet, which can facilitate internal sharing and ease staff access. The EPA
needs to have accurate, reliable and relevant Quality Management Plans
because they are an essential part of valid and reliable decisions. Chemical risk
assessments using high-quality data are critical to maintaining public trust in the
Recommendations and Planned Agency Corrective Actions
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention develop formal quality assurance training, direct RAD to
conduct internal quality assurance audits and training needs assessments, and
ensure that relevant RAD Quality Management Plans are updated when changes
to quality assurance activities occur. In addition, the Office of Chemical Safety
and Pollution Prevention needs to provide RAD's Quality Management Plan on
the OPPT Intranet and conduct a quality assurance analysis of OPPT to
determine whether all divisions have fully implemented their quality management
plans. The EPA agreed with our recommendations and has proposed acceptable
corrective actions. All recommendations are resolved.