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about the EPA OIG.

EPA’s Risk Assessment 

Division Has Not 

Fully Adhered to Its 

Quality Management Plan

Report No. 14-P-0350 September 10, 2014

 

RAD Quality 

Management 

Plan

Contribute to 

OPPT Annual 

Report

Provide 

Formal 

Training

Conduct 

Internal Audits

Document 

Revisions and 

Updates

Assign a 

Quality 

Assurance 

Coordinator

Conduct 

Management 

Reviews

Identify 

Training Needs

U.S. ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF INSPECTOR GENERAL
Report Contributors: Bakari Baker

Heather Drayton

Jeffrey Harris

Lauretta Joseph

Kalpana Ramakrishnan

Abbreviations

EPA U.S. Environmental Protection Agency

FY Fiscal Year

IRIS Integrated Risk Information System

OEI Office of Environmental Information

OIG Office of Inspector General

OPPT Office of Pollution Prevention and Toxics

QAC Quality Assurance Coordinator

QAM Quality Assurance Manager

RAD Risk Assessment Division

TSCA Toxic Substances Control Act

Cover photo: Elements of the RAD Quality Management Plan. (EPA OIG image—

colors chosen at random)

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 14-P-0350

September 10, 2014

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

or visit www.epa.gov/oig.

The full report is at:

www.epa.gov/oig/reports/2014/ 

20140910-14-P-0350.pdf

 

EPA’s Risk Assessment Division Has Not 

Fully Adhered to Its Quality Management Plan

 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.

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 

EPA.

 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.

U.S. Environmental Protection Agency

Office of Inspector General

At a Glance

Without a robust quality 

management system, 

RAD risks making 

environmental and 

human health policy 

decisions that rest on a 

faulty foundation.
September 10, 2014

MEMORANDUM

SUBJECT: EPA’s Risk Assessment Division Has Not Fully Adhered to Its 

Quality Management Plan

Report No. 14-P-0350

FROM: Arthur A. Elkins Jr.

TO: Jim Jones, Assistant Administrator

Office of Chemical Safety and Pollution Prevention

This is our report on the subject evaluation conducted by the Office of Inspector General (OIG) of the 

U.S. Environmental Protection Agency (EPA). This report contains findings that describe problems the 

OIG has identified and corrective actions the OIG recommends. This report represents the opinion of the 

OIG and does not necessarily represent the final EPA position. Final determinations on matters in this 

report will be made by EPA managers in accordance with established audit resolution procedures. 

The offices with primary jurisdiction over the issues evaluated in this report are the Office of Chemical 

Safety and Pollution Prevention’s Office of Pollution Prevention and Toxics, and the Office of Pollution 

Prevention and Toxics’ Risk Assessment Division.

Action Required 

You are not required to provide a written response to this final report because you provided agreed-to 

corrective actions and planned completion dates for the report recommendations. The OIG may make 

periodic inquiries on your progress in implementing these corrective actions. Should you choose to 

provide a final response, we will post your response on the OIG’s public website, along with our 

memorandum commenting on your response. You should provide your response as an Adobe PDF file 

that complies with the accessibility requirements of Section 508 of the Rehabilitation Act of 1973, as 

amended. 

We will post this report to our website at http://www.epa.gov/oig.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

THE INSPECTOR GENERAL
EPA’s Risk Assessment Division Has Not Fully 14-P-0350

Adhered to Its Quality Management Plan

Table of Contents

Purpose ..................................................................................................................... 1

Background ............................................................................................................... 1

Responsible Offices.................................................................................................. 4

Scope and Methodology........................................................................................... 4

Results of Review ..................................................................................................... 4

Conclusions .............................................................................................................. 7

Recommendations ................................................................................................... 8

Agency Comments and OIG Evaluation .................................................................. 8

Status of Recommendations and Potential Monetary Benefits ............................. 9

Appendices

A Agency Response to Draft Report and OIG Comments................................. 10

B Distribution ....................................................................................................... 15
14-P-0350 1

Purpose

Our objective was to determine to what extent the U.S. Environmental Protection 

Agency’s (EPA’s) Office of Pollution Prevention and Toxics’ (OPPT’s) Risk 

Assessment Division (RAD) uses and implements quality management policies 

during chemical risk assessments.

Background

Since 1979, the EPA has required all organizations1supporting environmental 

programs to participate in the agencywide quality system. The EPA’s Office of 

Environmental Information (OEI) is responsible for developing quality assurance 

and quality control requirements2and overseeing the agencywide quality system. 

The goal of the quality management system is to “ensure that environmental 

data. . . are of sufficient quantity and adequate quality to support the data’s

intended use.”3 A consistent quality management system, when implemented, will 

provide the EPA the needed technical practices and management to assure that the 

agency decisions are supported by adequate environmental data. 

Each EPA office that collects, evaluates and uses environmental data is required 

to develop a Quality Management Plan. The Quality Management Plan defines an 

organization’s quality-related policies, procedures, roles, responsibilities and 

authorities. According to the EPA Quality Manual for Environmental Programs,

4

the OEI reviews and approves an office’s Quality Management Plan, which is 

then valid for 5 years. 

To assess the effectiveness of the approved quality management plan, program

offices are required to submit a Quality Assurance Annual Report and Work Plan

to the OEI. The OEI also conducts periodic assessments of the EPA’s 

environmental programs to determine the effectiveness of their mandatory quality 

systems and recommend corrective actions.

 

1 EPA Policy CIO 2105.0 (EPA Order 2105), Policy and Program Requirements for the Mandatory Agency-Wide 

Quality System, defines an organization as an office, region, national center or laboratory that collects or uses 

environmental data.

2 Quality assurance is an integrated system of management activities to ensure high-quality processes and products. 

Quality control, in contrast, focuses on the quality of technical and operational activities. We focused on quality 

assurance and related management activities in this report.

3 EPA Order 2105 provides minimum quality system requirements for EPA organizations that collect or use 

environmental data. EPA Policy CIO 2106.0, EPA Quality Program Policy, “provides the structure and procedures 

to ensure and enhance the effectiveness of the quality program and its application to agency products and services.”

In addition, the EPA issued its Information Quality Act guidelines in 2002.

4 The EPA Quality Manual for Environmental Programs provides the minimum program requirements for 

implementing the mandatory Quality System defined in EPA CIO 2105-P-01-0.
14-P-0350 2

OPPT and Its Quality Management Plan

OPPT manages programs under the Toxic Substances Control Act (TSCA). The 

objective of TSCA is to “allow the EPA to regulate new commercial chemicals 

before they enter the market, to regulate existing chemicals when they pose an 

unreasonable risk to human health or the environment, and to regulate their 

distribution and use.”

5 OPPT gathers data to provide the EPA information that can 

be used and analyzed to reduce the risk of chemical exposure. OPPT helps to 

ensure that chemicals used and sold in the United States do not harm human 

health and the environment. OPPT has six divisions to address the production, 

importation, use and disposal of both existing and new chemicals (see figure 1).

Figure 1. OPPT organizational chart

Source: OPPT.

OPPT’s Director is responsible for the overall quality of OPPT’s programs, in

accordance with their quality management plan. The OPPT Director delegates 

management of quality assurance activities to the Quality Assurance Manager

(QAM). The QAM has full responsibility and authority to implement OPPT’s 

quality assurance activities with respect to the agency’s quality management 

systems. The QAM is the official point of contact for all quality assurance matters 

and is the liaison between OPPT and OEI. The QAM is responsible for reviewing 

and approving each OPPT division’s Quality Management Plan and quality 

assurance project plans. Each OPPT Division Deputy Director works as the 

Quality Assurance Coordinator (QAC) and oversees the division’s quality 

assurance activities. 

OPPT began an office reorganization in the fall of 2013 which coincided with 

OPPT’s 5-year Quality Management Plan renewal deadline. OPPT requested an 

extension to submit the renewed Quality Management Plans to OEI and OEI 

approved the extension. OEI may grant an extension if it recently conducted a 

quality systems assessment, and OEI had conducted a quality systems assessment 

 

5

15 U.S.C. §2601.
14-P-0350 3

of OPPT in November 2012. OEI’s 2012 quality systems assessment found that 

OPPT’s quality systems were in compliance with their Quality Management Plan.

OPPT must submit an updated Quality Management Plan to OEI by September 

2014. Although OPPT has its own Quality Management Plan, each of its six 

divisions are responsible for implementing its own divisional Quality 

Management Plan.

RAD and Its Quality Management Plan

RAD consists of four branch offices (see figure 2) and is responsible for 

numerous activities assessing the health and environmental hazards and risks of 

new and existing chemicals and microorganisms for both regulatory and 

non-regulatory programs. The division’s responsibilities include assessing the 

hazards of high-production-volume chemicals. The main components of these 

assessments are reviewing and evaluating test data submitted under TSCA for 

environmental and health effects. RAD also manages the Structure-Activity 

Team, which is responsible for initial assessment of fate and effects of chemicals.

Figure 2. RAD organizational chart

 

Source: RAD.

According to RAD’s Quality Management Plan, it uses numerous tools to ensure 

data quality.

6 RAD develops Quality Assurance Project Plans and uses standard 

operating procedures and other guidance documents to prepare work products and 

risk assessments. RAD uses external peer reviews, such as the agency’s Science 

Advisory Board; journal article and paper peer reviews; and, occasionally, the 

Office of Pesticide Program’s Science Advisory Panel. The RAD QAC is 

assigned the responsibility to assess quality assurance training needs and conducts 

annual internal audits of its quality assurance program. The branch chiefs are 

responsible for ensuring that needed training is scheduled, funded and taken. OEI 

guidance provides information on minor and major revisions. Minor revisions to 

the Quality Management Plan must be documented in the annual quality 

assurance report. Major revisions or reissuance of the Quality Management Plan 

are required when there is a significant mission change or major reorganizations. 

Similar to OPPT, RAD has committed to submitting an updated Quality 

Management Plan for approval to OEI by September 2014.

 

6 The RAD “Quality Management Plan exists in the context of the OPPT Quality Management Plan,” which is under 

the control of the OPPT QAM. 
14-P-0350 4

Responsible Offices 

The offices responsible for the issues evaluated in this report are the Office of 

Chemical Safety and Pollution Prevention’s OPPT and OPPT’s RAD.

Scope and Methodology

We conducted this performance audit in accordance with generally accepted 

government auditing standards. Those standards require that we plan and perform 

the audit to obtain sufficient, appropriate evidence to provide a reasonable basis 

for our findings and conclusions based on our objectives. We believe that the 

evidence obtained provides a reasonable basis for our results based upon our 

objectives. We conducted this audit from January to July 2014.

We reviewed relevant documents, including laws, regulations, policies and 

procedures. We focused on management activities listed in EPA Order 2105 and

the EPA Quality Manual for Environmental Programs. We also reviewed quality 

guidance documents, including the current OPPT and RAD Quality Management 

Plans.

7

Our review of the current RAD Quality Management Plan focused on quality 

assurance training, internal audits and Quality Management Plan revisions. We 

interviewed agency officials, including OEI’s Director of Quality Staff, OPPT’s 

Deputy Director of Programs, OPPT’s QAM, RAD’s Division Director and 

Deputy Division Director/QAC, and other RAD personnel. We reviewed the 

RAD’s Quality Assurance Project Plans, standard operating procedures, and the 

fiscal years (FYs) 2009/2010, 2012/2013 and 2013/2014 annual quality assurance 

reports and work plans. We obtained information regarding quality assurance 

training and types of RAD work products. We reviewed quality management 

plans from the Office of Pesticide Programs and the Office of Research and 

Development. We also reviewed annual quality assurance reports from the Office 

of Resource Conservation and Recovery and the Office of Pesticide Program’s 

Biological and Economic Analysis Division.

Results of Review

According to the RAD’s Quality Management Plan, the division uses the elements

shown in table 1 to ensure data quality. During our review, we found that RAD 

has adhered to some but not all aspects of its current Quality Management Plan. 

RAD did not fully implement key aspects of its Quality Management Plan related 

to training, internal audits and plan revisions. Additionally, we found that, unlike 

other agency offices business practices, RAD does not post its Quality 

Management Plan online.

 

 

7 For both OPPT and RAD, the 2008 Quality Management Plan is the most current version.
14-P-0350 5

Table 1: RAD adherence to quality assurance activities

Quality assurance requirement Adherence

RAD QAC assigned. Yes

Management review of quality assurance project plans and 

standard operating procedures.

Yes

Identification of quality assurance training needs. No

Provide in-house quality assurance training. No

Contribute to the OPPT annual report. Yes

Revisions and updates to Quality Management Plan. No

Yearly internal audits of divisional quality assurance program. No

Source: OIG analysis of quality management plan requirements.

Quality Assurance Training

Within its Quality Management Plan, RAD lists “providing in-house formal 

training classes” as a training mechanism. Yet RAD is not ensuring managers and 

staff take in-house formal quality assurance training—a key aspect of its current 

Quality Management Plan. RAD training mechanisms include: attending 

scientific and professional society meetings and workshops, attending seminars 

and training classes offered by various software and vendors, and offering 

recertification classes and informal peer-to-peer training. The Office of Water 

offered quality assurance training in FY 2013 that only seven RAD staff members 

attended; however, although applicable to the environmental data RAD works 

with, the training was not RAD-specific. 

RAD senior management stated that RAD does not have formal quality assurance 

training.

8 One of RAD’s four branch chiefs commented that he could not 

remember taking any quality assurance training since becoming a branch chief.

The RAD division director informed the Office of Inspector General (OIG) that 

their training process is informal. In FY 2012/2013, informal training was 

achieved through a technical discussion of topics presented to a team of peers. 

RAD also relies on branch chiefs and project managers to train staff through 

mentoring. However, without formal quality assurance training, RAD will be 

unable to ensure that the information passed from mentoring is consistent or the 

best quality assurance information is available. Additionally, without formal 

training in place, institutional knowledge can be lost with employee attrition.

 

8 OEI does not provide a formal overall quality assurance training program. 
14-P-0350 6

OPPT is aware of the need to provide quality assurance training to its staff. The 

QAM acknowledged the quality assurance training gap and plans to develop 

specific quality assurance training for OPPT, which will include RAD. The QAM 

stated that there are plans to design training with other agency QAMs, which 

would potentially establish a more solid program for the entire OPPT quality 

assurance system. Additionally, a meeting was held in March 2014 with the EPA 

quality assurance community to discuss ways to better serve their respective 

program offices. 

In addition to requiring quality assurance training, RAD’s current Quality 

Management Plan states that the QAC is responsible for conducting formal 

quality assurance training needs assessments. Training needs assessments are 

necessary to ensure that quality assurance-related training needs are addressed and 

the resources are available to complete the training. However, according to 

OPPT’s quality assurance annual reports (FYs 2009, 2012 and 2013), RAD did 

not conduct a formal quality assurance training needs assessment.

Internal Quality Assurance Audits

The RAD QAC has not conducted internal audits of their quality assurance 

programs. A quality audit is defined as “a systematic and independent 

examination to determine whether quality activities and related results comply 

with planned arrangements and whether these arrangements are implemented 

effectively and are suitable to achieve objectives.”9 As stated earlier, the role of 

the QAC is to ensure quality assurance of their division. According to the current 

RAD Quality Management Plan, the division’s QAC is required to conduct annual 

internal quality assurance audits of their programs. According to OPPT’s quality 

assurance annual reports (FYs 2009, 2012 and 2013), RAD did conduct routine 

reviews of work products by staff and the assigned management teams. RAD also 

had external peer reviews of scientific data. However, these activities do not

qualify as annual internal quality audits by RAD QAC. Moreover, during 

interviews, RAD senior management acknowledged that their division has not 

conducted any internal quality assurance audits. Routine internal quality 

assurance audits help identify potential deficiencies in data quality and 

management controls.

Quality Management Plan Revisions 

RAD has not revised its Quality Management Plan when changes occurred to its 

program activities, including major risk assessment responsibilities. The EPA 

Quality Manual for Environmental Programs requires that the Quality 

Management Plan be reviewed annually and updated or reissued as needed. 

Necessary updates include major revisions to program roles and responsibilities. 

The current RAD Quality Management Plan specified that they develop and 

prepare Integrated Risk Information System (IRIS) assessments. In contrast, RAD 

 

9 Defined by the EPA Quality Manual for Environmental Programs, CIO 2105-P-01-0, May 2000.
14-P-0350 7

stopped producing IRIS assessments in 2011 and a subsequent Federal Register 

notice announced the elimination of RAD’s role in the IRIS preparation. 

However, the revisions to their quality assurance activities regarding IRIS 

assessments have not been documented in either the quality assurance annual 

report and work plan or a revised Quality Management Plan. In addition, the 

current RAD Quality Management Plan included information on the Chemical 

Assessment and Management Program, which is a program that ceased in 2009. 

Although this change was contained in the FY 2009 annual quality assurance 

report, it was a major shift in quality assurance activities for RAD and, therefore,

should have resulted in a revision or reissuance of their Quality Management Plan 

in accordance with the EPA and RAD quality assurance guidance.

Quality Management Plan Accessibility

RAD does not post its Quality Management Plan on its Intranet. Posting the plan 

would increase transparency and enhance availability to the EPA staff. As a good 

business practice, we found that other agency offices make their quality 

management plans available to all by posting it on the EPA’s Intranet. Quality 

management plans, annual quality assurance reports, internal audits, and revisions 

to the plans that are posted to an intranet can be easily found by managers and 

staff. For instance, the Office of Pesticide Programs has its Quality Management 

Plan online. Its Quality Management Plan includes training requirements for its

QAM, quality assurance officers and contracting officer representatives. It goes 

further to list the specific quality assurance training that these individuals must 

take. The Office of Research and Development includes revisions or updates to its

Quality Management Plan on the Office of Research and Development’s Intranet. 

Conclusions

The lack of adherence to several aspects of RAD’s Quality Management Plan 

creates the risk that RAD’s quality system cannot meet the EPA’s quality 

management system’s goal. Without a robust quality management system, RAD

risks having environmental and human health policy decisions that rest on a faulty 

foundation. To enhance its quality management system, RAD needs to implement 

quality assurance training and conduct training needs assessments to ensure that 

managers and staff obtain relevant quality assurance knowledge. RAD’s QAC 

needs to conduct annual independent reviews of the division’s quality assurance 

processes to assure the quality of work products. 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 EPA. 
14-P-0350 8

Recommendations

We recommend that the Assistant Administrator for Chemical Safety and 

Pollution Prevention: 

1. Develop formal quality assurance training that enhances awareness and 

understanding of relevant quality management policies and requirements 

for managers and staff to prevent loss of institutional knowledge and 

comply with their Quality Management Plan.

2. Direct RAD’s QAC to conduct annual internal quality assurance audits in 

accordance with RAD’s Quality Management Plan.

3. Direct RAD to identify and document individual staff training needs to 

ensure that RAD addresses quality assurance-related training gaps.

4. Ensure that RAD’s Quality Management Plan and/or OPPT’s quality 

assurance annual report and work plan are updated accordingly when 

minor and major changes to RAD’s quality assurance activities are made. 

5. Provide internal online access to RAD’s Quality Management Plan to 

increase staff accessibility to relevant quality assurance activities.

6. Conduct a quality assurance analysis of OPPT to determine whether all 

divisions have fully implemented their Quality Management Plans.

Agency Comments and OIG Evaluation

The agency agreed with our recommendations, and provided corrective actions 

and estimated completion dates that meet the intent of the recommendations. 

Based on the agency’s written response, we have determined that the 

recommendations are resolved and open with corrective actions ongoing. One 

recommendation is closed due to being implemented prior to the final report 

issuance. No further response to this report is required. The agency’s detailed 

response is in appendix A and our response to the agency is embedded in 

appendix A. The agency also provided technical comments on the draft report, 

which we have incorporated into our report as appropriate.
14-P-0350 9

Status of Recommendations and 

Potential Monetary Benefits

RECOMMENDATIONS

POTENTIAL MONETARY 

BENEFITS (in $000s)

Rec. 

No.

Page 

No. Subject Status1 Action Official

Planned 

Completion 

Date

Claimed 

Amount

Agreed-To 

Amount

1 8 Develop formal quality assurance training that 

enhances awareness and understanding of 

relevant quality management policies and 

requirements for managers and staff to prevent 

loss of institutional knowledge and comply with 

their Quality Management Plan.

O Assistant Administrator for 

Chemical Safety and 

Pollution Prevention

12/31/14

2 8 Direct RAD’s QAC to conduct annual internal 

quality assurance audits in accordance with RAD’s 

Quality Management Plan.

O Assistant Administrator for 

Chemical Safety and 

Pollution Prevention

9/30/15

3 8 Direct RAD to identify and document individual staff 

training needs to ensure that RAD addresses 

quality assurance-related training gaps.

O Assistant Administrator for 

Chemical Safety and 

Pollution Prevention

9/30/15

4 8 Ensure that RAD’s Quality Management Plan 

and/or OPPT’s quality assurance annual report and 

work plan are updated accordingly when minor and 

major changes to RAD’s quality assurance 

activities are made.

O Assistant Administrator for 

Chemical Safety and 

Pollution Prevention

9/30/15

5 8 Provide internal online access to RAD’s Quality 

Management Plan to increase staff accessibility to 

relevant quality assurance activities.

C Assistant Administrator for 

Chemical Safety and 

Pollution Prevention

7/29/14

6 8 Conduct a quality assurance analysis of OPPT to 

determine whether all divisions have fully 

implemented their Quality Management Plans.

O Assistant Administrator for 

Chemical Safety and 

Pollution Prevention

9/30/15

1 O = Recommendation is open with agreed-to corrective actions pending.

C = Recommendation is closed with all agreed-to actions completed.

U = Recommendation is unresolved with resolution efforts in progress.
14-P-0350 10

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

Appendix A 

Agency Response to Draft Report and OIG Comments

July 30, 2014

MEMORANDUM

SUBJECT: Response to Office of Inspector General Draft Report No. OPE-FY14-0012 

“EPA’s Risk Assessment Division has Not Fully Adhered to Its Quality 

management Plan,” dated June 30, 2014 

FROM: James J. Jones

Assistant Administrator for Chemical Safety and Pollution Prevention

TO: Arthur A. Elkins, Jr.

Inspector General (OIG)

Thank you for the opportunity to respond to the subject audit report. This memorandum provides 

the Agency’s response to OIG’s recommendations, and identifies corrective actions the Agency 

will be taking in response (Attachment A). In addition, the Agency has suggested technical 

corrections to improve the accuracy of the report (Attachment B).

Every day the Office of Pollution Prevention and Toxics (OPPT) produces and uses scientific 

and technical work products that inform Agency decision making. We make approximately 

1,000 new chemicals decisions a year based on assessments that are unchallenged by industry 

and other stakeholders. Our tools and models are used around the world for chemicals-related 

decision making. OPPT scientists play leading roles internationally in such bodies as the OECD 

to develop the next-generation of chemical assessment guidelines and risk assessment 

approaches. OPPT’s Work Plan risk assessment program for existing chemicals is producing 

assessments that are subjected to independent, expert review that surpasses in rigor federal and 

Agency guidelines for peer review. It is notable that the external peer reviews of all the Work 

Plan assessments we have completed thus far have supported our overall assessment 

methodologies and conclusions. OPPT’s record of strong and sound science is consistent with 

OIG Response: The scope of our evaluation did not include a review of the quality of 

OPPT’s scientific and technical work products.
14-P-0350 11

the fact that your office’s review of our quality system found no concerns with the quality of 

OPPT’s scientific and technical work products.

The administrative recommendations that have resulted from your audit are very useful, and we 

look forward to implementing them. The report contains a total of six recommendations:

Recommendation 1. Develop formal quality training that enhances awareness and understanding 

of relevant quality management policies and requirements for managers and staff to prevent loss 

of institutional knowledge and comply with their quality management plan.

Recommendation 2. Direct RAD’s QAC to conduct annual internal quality assurance audits in 

accordance with RAD’s Quality Management Plan. 

Recommendation 3. Direct RAD to identify and document individual staff training needs to 

ensure that RAD addresses quality assurance-related training gaps.

Recommendation 4. Ensure that RAD’s Quality Management Plan and/or OPPT’s quality 

assurance annual report and work plan updated accordingly when minor and major changes to 

RAD’s quality assurance activities are made.

Recommendation 5. Provide internal online access to RAD’s Quality Management Plan to increase 

staff accessibility to relevant quality assurance activities.

Recommendation 6. Conduct a quality assurance analysis of OPPT to determine whether all divisions 

have fully implemented their Quality Management Plans.

The Agency concurs with all of the report recommendations and will begin steps to implement 

the corrective actions identified in Attachment A. 

We do take issue with one finding. The draft report states (p. 7) that OPPT’s changes in program 

activities since 2009 have led to a major shift in quality assurance activities, and implies that its 

current Quality Management Plan is not accurate, reliable, or relevant. The final report should 

take care not to convey this implication. Our QMP is relevant to and supportive of all OPPT 

scientific and technical activities, including our new and existing chemical risk assessments. 

While the policy goals and programmatic focus for conducting data reviews and evaluations 

within OPPT have changed over the past 5 years, the sources and types of data, the evaluation 

approaches and tools, and the QA/QC activities associated with using this data have not changed 

significantly or substantively. This is largely due to OPPT’s adherence to Agency assessment 

guidelines and contract management processes and procedures. We did not make changes to the 

QMP because changes in program activities were explained in the Quality Assurance Annual 

Report and Work Plan (QAARWP), and the QA/QC activities did not change in any substantive 

way. Each QAARWP has a section for addressing changes to the QMP. In each of the 

QAARWPs for 2008-2013, OPPT noted that no changes to the QMP were warranted; the 

QAARWPs were submitted to and accepted by the Agency’s Office of Environmental 

Information. 
14-P-0350 12

If you have questions or need further information about this response, please contact Deborah 

Hartman, OCSPP’s Audit Liaison at (202) 564-1488. 

OIG Response: The OIG did not state that RAD’s current QMP is not accurate, reliable or 

relevant. We specifically state that RAD has adhered to some but not all aspects of its 

current quality management plan. OEI’s guidance was used to determine RAD’s use and 

implementation of its QMP. Our review of OEI guidance and RAD’s activities indicated 

that certain RAD program changes were major activities and thereby should have resulted 

in an updated QMP. OIG suggests that OPPT contact OEI to obtain more information or 

request updated guidance that further clarifies how to determine a major activity.
14-P-0350 13

Attachment A: Corrective Action Plan

EPA’s Risk Assessment Division Has Not Fully Adhered to Its Quality Management Plan 

Report No. OPE-FY14-0012 (June 30, 2014)

Recommendation Corrective Action Target Date

Recommendations to OCSPP Assistant Administrator

1. Develop formal quality 

training that enhances 

awareness and 

understanding of 

relevant quality 

management policies 

and requirements for 

managers and staff to 

prevent loss of 

institutional knowledge 

and comply with their 

quality management 

plan.

OCSPP accepts the 

OIG recommendation.

OPPT will develop a 

formal quality training

program.

FY15; Q1

2. Direct RAD’s QAC to 

conduct annual internal 

quality assurance audits 

in accordance with 

RAD’s Quality 

Management Plan.

OCSPP accepts the 

OIG recommendation.

The OPPT-RAD QAC 

will conduct internal 

quality assurance 

audits.

Annually, beginning in FY15.

3. Direct RAD to identify 

and document 

individual staff training 

needs to ensure that 

RAD addresses quality 

assurance-related 

training gaps.

OCSPP accepts the 

OIG recommendation.

OPPT-RAD will 

identify and document 

Division staff training 

needs in the annual 

QA/AC report.

Individual staff 

training needs will be 

addressed in 

Individual 

Development Plans

Annually, beginning in FY15.

4. Ensure that RAD’s 

Quality Management 

Plan and/or OPPT’s 

quality assurance 

annual report and work 

OCSPP accepts the 

OIG recommendation.

OPPT-RAD will more 

explicitly identify and 

Annually, beginning in FY15 or when a 

major change in QA/QC activity occurs.
14-P-0350 14

plan updated 

accordingly when 

minor and major 

changes to RAD’s 

quality assurance 

activities are made.

document, in the 

annual QA/QC report, 

when changes to 

quality assurance 

activities are made.

5. Provide internal online 

access to RAD’s Quality 

Management Plan to 

increase staff 

accessibility to relevant 

quality assurance 

activities.

OCSPP accepts the 

OIG recommendation.

OPPT has posted its 

QMP on the intranet. 

Completed

July 29, 2014

http://intranet.epa.gov/opptwork/qualitymanagement/

6. Conduct a quality 

assurance analysis of 

OPPT to determine 

whether all divisions 

have fully implemented 

their Quality 

Management Plans.

OCSPP accepts the 

OIG recommendation.

FY15
14-P-0350 15

Appendix B

Distribution

Office of the Administrator 

Assistant Administrator for Chemical Safety and Pollution Prevention 

Agency Follow-Up Official (the CFO) 

Agency Follow-Up Coordinator 

General Counsel 

Associate Administrator for Congressional and Intergovernmental Relations 

Associate Administrator for External Affairs and Environmental Education 

Deputy Assistant Administrator for Chemical Safety and Pollution Prevention 

Director, Office of Pollution Prevention and Toxics, Office of Chemical Safety and 

Pollution Prevention

Director, Risk Assessment Division, Office of Pollution Prevention and Toxics, 

Office of Chemical Safety and Pollution Prevention

Audit Follow-Up Coordinator, Office of Chemical Safety and Pollution Prevention 

Audit Follow-Up Coordinator, Office of Pollution Prevention and Toxics, 

Office of Chemical Safety and Pollution Prevention