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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Protecting America's Waters
EPA's Bristol Bay Watershed
Assessment: Obtainable Records
Show EPA Followed Required
Procedures Without Bias or
Predetermination, but a
Possible Misuse of Position Noted
Report No. 16-P-0082
January 13, 2016

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Report Contributors:	Patrick Gilbride
Randy Holthaus
Luke Stolz
Erin Barnes-Weaver
Ganesa Curley
Abbreviations
CWA
Clean Water Act
EPA
U.S. Environmental Protection Agency
HISA
Highly Influential Scientific Assessment
OIG
Office of Inspector General
OMB
Office of Management and Budget
ORD
Office of Research and Development
OW
Office of Water
PLP
Pebble Limited Partnership
QAPP
Quality Assurance Project Plan
Cover photo: The Bristol Bay, Alaska, watershed study area. (EPA photo)
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U.S. Environmental Protection Agency	16-P-0082
^ SL "s 0ffice of Inspector General	January 13 2016
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At a Glance
Why We Did This Review
Based on congressional
inquiries and hotline
complaints, we conducted this
review regarding the actions of
the U.S. Environmental
Protection Agency (EPA) and
its decision to conduct an
assessment of the Bristol Bay
watershed in Alaska.
We sought to determine
whether the EPA conducted
the assessment in a biased
manner; predetermined the
outcome; and followed policies
and procedures for ecological
risk assessment, peer review
and information quality.
The Bristol Bay watershed,
home to 25 federally
recognized tribal governments,
contains large amounts of
copper and gold. The EPA
conducted its watershed
assessment from February
2011 through January 2014 to
determine the significance of
Bristol Bay's ecological
resources and evaluate the
potential impacts of large-scale
mining on those resources.
This report addresses the
following EPA goals or
cross-agency strategies:
•	Protecting America's
waters.
•	Launching a new era of
state, tribal, local, and
international partnerships.
Send all inquiries to our public
affairs office at (202) 566-2391
or visit www.epa.gov/oiq.
Listing of OIG reports.
EPA's Bristol Bay Watershed Assessment-
Obtainable Records Show EPA Followed Required
Procedures Without Bias or Predetermination,
but a Possible Misuse of Position Noted
What We Found
Based on available information, we found
no evidence of bias in how the EPA conducted
its assessment of the Bristol Bay watershed, or
that the EPA predetermined the assessment
outcome. We also found that the EPA's
assessment appropriately included sections on
the three primary phases discussed in the
agency's ecological risk assessment
guidelines. Further, the EPA met requirements
for peer review, provided for public involvement
throughout the peer review process, and
followed procedures for reviewing and verifying the
assessment before releasing it to the public.
The EPA addressed
guidelines and followed
policies and procedures
when conducting the Bristol
Bay watershed assessment.
We found no evidence of
bias or a predetermined
outcome. We did find a
possible misuse of position
by a Region 10 employee
who retired in 2013.
quality of information in the
We did find that an EPA Region 10 employee used personal nongovernmental
email to provide comments on a draft Clean Water Act Section 404(c) petition
from tribes before the tribes submitted it to the EPA. We found this action was a
possible misuse of position, and the EPA's Senior Counsel for Ethics agreed.
Agency employees must remain impartial in dealings with outside parties,
particularly those that are considering petitioning or have petitioned the agency to
take action on a matter. This employee retired from the EPA in April 2013.
Scope Limitations
In conducting our review, we obtained email records and documents from the
agency and an external source. The agency was unable to provide all
government emails for the retired employee. In addition, despite issuing a
subpoena, we were unable to obtain additional personal emails for the retired
employee. Our report therefore reflects findings based on available information.
Recommendations and Planned Agency Corrective Actions
We recommend that the EPA incorporate, in the agency's ethics training,
examples of misuse of position in interactions with stakeholders, and define and
incorporate in mandatory EPA tribal training the appropriate and ethical
parameters of tribal assistance. We also recommend that the Regional
Administrator, Region 10, issue a memo to staff emphasizing the importance of
adhering to standards of ethical conduct, particularly when dealing with external
parties with an interest in regulatory or administrative action. The agency agreed
with all of our recommendations and proposed adequate corrective actions.

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I Q \
i	|	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
%	o*	WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
January 13, 2016
MEMORANDUM
SUBJECT: EPA's Bristol Bay Watershed Assessment: Obtainable Records Show
EPA Followed Required Procedures Without Bias or Predetermination,
but a Possible Misuse of Position Noted
Report No. 16-P-0082
FROM: Arthur A. Elkins Jr. /'V^/^
TO:	Avi Garbow, General Counsel
Office of General Counsel
Jane Nishida, Principal Deputy Assistant Administrator
Office of International and Tribal Affairs
Dennis McLerran, Regional Administrator
Region 10
This is our report on the subject evaluation conducted by the Office of Inspector General (OIG) of the
U.S. Environmental Protection Agency (EPA) based on congressional inquiries and hotline complaints.
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 EPA offices with responsibility for the recommendations in this report include the Office of General
Counsel, the Office of International and Tribal Affairs, and Region 10.
Action Required
In accordance with EPA Manual 2750, your office provided acceptable corrective actions and milestone
dates in response to OIG recommendations. All recommendations are resolved and no final response to
this report is required.
We will post this report to our website at www.epa.gov/oig.

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EPA's Bristol Bay Watershed Assessment:	16-P-0082
Obtainable Records Show EPA Followed
Required Procedures Without Bias or Predetermination,
but a Possible Misuse of Position Noted
Table of C
Chapters
1	Introduction		1
Purpose		1
Background		1
Responsible Offices		4
Scope and Methodology		4
Scope Limitations		5
2	EPA's Bristol Bay Watershed Assessment		7
Events That Led to EPA's Decision to Conduct the
Bristol Bay Watershed Assessment		7
Issuance of EPA's Bristol Bay Watershed Assessment		9
EPA Issued Notice of Intent to Make a CWA Section 404(c)
Determination		9
3	Obtainable Records Showed No Evidence of Bias or
Predetermination, and EPA Followed Policies and Procedures
While Conducting Assessment		11
Obtainable Records Showed No Evidence of Bias or
Predetermination Related to How EPA Conducted Assessment		11
EPA Addressed Guidelines on Risk Assessment, and Followed
Procedures on Peer Review and Information Quality		11
4	Possible Misuse of Position May Have Occurred
Prior to the Assessment		15
Possible Misuse of Position by EPA Employee Involved With Petition		15
Conclusion		17
Recommendations		17
Agency Comments and OIG Evaluation		18
Status of Recommendations and Potential Monetary Benefits		19
-continued-

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EPA's Bristol Bay Watershed Assessment:	16-P-0082
Obtainable Records Show EPA Followed
Required Procedures Without Bias or Predetermination,
but a Possible Misuse of Position Noted
Appendices
A Details on Scope and Methodology		20
B Analysis of Assessment's Adherence to Procedures for
Ecological Risk Assessment, Peer Review and Information Quality		23
C Agency Response to Draft Report		27
D Distribution		30

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Chapter 1
Introduction
Purpose
We received multiple congressional inquiries and hotline complaints regarding
the actions of the U.S. Environmental Protection Agency (EPA) leading up to its
decision to conduct its Bristol Bay watershed assessment. This included the
processes the EPA used to develop and issue the resulting report, An Assessment
of Potential Mining Impacts on Salmon Ecosystems of Bristol Bay, Alaska
(hereafter, "the assessment").1 Based on these inquiries and complaints, we
sought to determine whether the EPA adhered to laws, regulations, policies and
procedures in developing its assessment. Specifically, we addressed:
•	The reason the EPA conducted the assessment and whether there was any
evidence that the EPA conducted the assessment in a biased manner or it
had a predetermined outcome.
•	Whether the EPA followed ecological risk assessment policies and
procedures when conducting the assessment.
•	Whether the EPA followed peer review policies and procedures.
•	Whether the EPA followed the Information Quality Act and related
policies and procedures.
Background
Bristol Bay Watershed
The Bristol Bay watershed is located in southwestern Alaska. According to the
EPA, the watershed's streams, wetlands and other aquatic resources support
world-class, economically important commercial and sport fisheries for salmon
and other fishes, as well as a more than 4,000-year-old subsistence-based way of
life for Alaska Natives. The area is home to 25 federally recognized tribal
governments.
The Bristol Bay watershed also contains large mineral deposits. The Pebble
deposit is the largest-known deposit in the area, and the most explored for future
mining potential. The Pebble deposit contains large amounts of copper, gold and
molybdenum.
Figure 1 shows a map of the Bristol Bay watershed.
1 The full version of this assessment can be found on the EPA's website for Bristol Bay.
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Figure 1: The Bristol Bay watershed, composed of the Togiak, Nushagak, Kvichak,
Naknek, Egegik and Ugashik River watersheds and the North Alaska Peninsula
NUSHAGAK
NORTKALASmk PENINSULA
N
A

A
0 50
100


0 50
100


"A" Approximate Pebble Deposit Location
• Towns and Villages
Watershed Boundary
Parks, Refuges, or Preserves
Bristol Bay
Cook Inlet
Source: EPA's proposed determination issued in July 2014.
The Pebble Limited Partnership
In 2001, Northern Dynasty Minerals Ltd. began studying the Bristol Bay
watershed area for the purpose of undertaking mining activities in the Pebble
deposit. According to EPA staff, they became aware of exploration in the area in
the early 2000s. The EPA began working with Northern Dynasty in or about 2003
regarding the potential mine. In 2004, state and federal agency representatives2
started reviewing study plans and attending annual meetings that Northern
Dynasty sponsored.
In 2007, the Pebble Limited Partnership (PLP) was created by Northern Dynasty
and Anglo American pic.3 Since then, PLP has been the corporate entity exploring
the idea of constructing a mine at the Pebble deposit.
Beginning in 2007, EPA representatives participated in various technical working
groups with PLP to facilitate a coordinated process for reviewing and
commenting on environmental and project design studies in advance of any
permitting actions related to the Pebble Mine project. PLP suspended these
technical working groups in early 2010.
2	Among the representatives included were staff from the U.S. Fish and Wildlife Service, the U.S. Army Corps of
Engineers, and the state of Alaska.
3	Anglo American pic withdrew from the partnership in late 2013.
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In February 2011, Northern Dynasty formally submitted information4 to the
U.S. Securities and Exchange Commission to develop a large-scale mine at the
headwaters of Bristol Bay's Nushagak and Kvichak River watersheds. This
information, along with preliminary mine details put forth by Northern Dynasty5
and other information, was used by the EPA as the basis for developing various
mining scenarios, included in the Bristol Bay watershed assessment.
Clean Water Act
The 1972 Clean Water Act (CWA) establishes the basic structure for regulating
discharges of pollutants into waters of the United States. CWA Section 104(a)
allows the EPA to conduct research, investigations and studies relating to the
causes, effects, extent, prevention, reduction and elimination of pollution into
waters of the United States. Per Section 104(b), the EPA can cooperate with other
federal departments, state water pollution control agencies and individuals in the
research, and then collect and publish research results. The EPA conducted the
Bristol Bay watershed assessment under these authorities.
CWA Section 404 regulates the placement of dredged or fill material into waters
of the United States, including wetlands. The U.S. Army Corps of Engineers or an
approved state has responsibility for issuing CWA Section 404 permits. A CWA
Section 404 permit would be required to discharge dredged or fill material
associated with construction or operation of a mine at the Pebble deposit. Under
CWA Section 404(c), the EPA:
.. .is authorized to prohibit the specification (including the
withdrawal of specification) of any defined area as a disposal site,
and [it] is authorized to deny or restrict the use of any defined area
for specification (including the withdrawal of specification) as a
disposal site, whenever [it] determines, after notice and
opportunity for public hearings, that the discharge of such
materials into such area will have an unacceptable adverse effect
on municipal water supplies, shellfish beds and fishery areas
(including spawning and breeding areas), wildlife, or recreational
areas.
Before making such determination, the EPA shall consult with the U.S. Army
Corps of Engineers. The EPA has used its CWA Section 404(c) authority 13 times
to issue a final determination to restrict or prohibit disposal activities.
4	Referred to as SEC 2011.
5	Referred to as Ghaffari et al. 2011.
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Responsible Offices
The EPA offices with primary responsibility over the issues discussed in this
report include:
•	Office of Water (OW):
o Immediate Office
o Office of Wetlands, Oceans and Watersheds
•	Office of Research and Development (ORD):
o National Center for Environmental Assessment
o National Health and Environmental Effects Research Laboratory
o National Risk Management Research Laboratory
•	Office of International and Tribal Affairs
o American Indian Environmental Office
•	Office of General Counsel
o Ethics Office
•	Region 10:
o Regional Administrator's Office
o Office of Ecosystems, Tribal and Public Affairs
o Office of Regional Counsel
o Alaska Operations Office
Within the Office of General Counsel, the Principal Deputy General Counsel is
the Designated Agency Ethics Official.
Scope and Methodology
We conducted our review from May 2014 through October 2015 in accordance
with generally accepted government auditing standards. Those standards require
that we plan and perform the review to obtain sufficient, appropriate evidence to
provide a reasonable basis for our findings and conclusions based on our
objective. We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our objective.
To address our objective, we reviewed relevant materials pertaining to the process
used to develop the EPA's Bristol Bay watershed assessment, including policies
and procedures for conducting such assessments. We reviewed the processes used
to conduct the assessment, not the scientific content. We interviewed key staff
within the EPA's OW, ORD, Administrator's Office and Region 10. We also
interviewed a retired Region 10 Ecologist. In addition, with the assistance of our
Office of Inspector General (OIG) Office of Investigations, we obtained email
databases from the EPA's Office of Environmental Information for the employees
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discussed below. After using search terms to narrow our focus, we reviewed
8,352 emails sent or received from January 1, 2008, through May 18, 2012, for:6
•	The former acting Assistant Administrator for Water, given allegations
regarding her involvement with a former employer.
•	The Region 10 Regional Administrator, as he was the key regional
decision maker in taking any CWA Section 404(c) action.
•	A retired Region 10 employee, given allegations of the person's central
and influential involvement in the EPA's decision to take a CWA Section
404(c) action. This employee, a GS-13 Ecologist, was responsible, at a
staff level, for implementing and overseeing CWA provisions for portions
of Alaska and was one of 20 authors of, and an EPA technical lead for, the
assessment.
We reviewed these emails to look for any indications of bias in the EPA's actions
leading up to the decision to conduct the assessment and any indications of bias
during the assessment. We also looked for any evidence showing that the EPA
predetermined the outcome of the assessment. In addition, for the former acting
Assistant Administrator for Water, we also looked for documentation showing
improper contact with her former employer. We did not find any instances of
improper contact related to the scope of this review.
We also completed other steps, as described in Appendix A, to address the four
sub-objectives.
Scope Limitations
We are reporting scope limitations for this review. We could not review all emails
from the retired Region 10 employee's EPA email address. Region 10 identified
25 months of missing emails for the retired employee that overlapped with the
52-month time period of our review (January 1, 2008, through May 18, 2012). As a
result, we are unable to draw any specific conclusions related to that employee's
emails during that period. This limitation applies to the findings discussed in
Chapter 4 of this report.
In June 2014, the EPA notified the National Archives and Records Administration
of this potential loss of electronic documents. In March 2015, the EPA provided a
follow-up report related to the gap in email records. On June 24, 2015, the
National Archives and Records Administration provided a letter to the EPA
stating that it believes the EPA acted appropriately in addressing the absence of
6 We obtained email databases from EPA's Office of Environmental Information in the fall of 2014. Those
databases included information available at the time of retrieval. If an employee had deleted emails prior to our
retrieving the database, those deleted emails were not available. The EPA also provided us access to emails collected
in response to Freedom of Information Act and congressional requests. We did not perform a detailed review of
these emails but rather searched for information as needed. We also received and reviewed emails provided to us by
an attorney who represented six federally recognized tribes.
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email as an unauthorized and accidental loss of federal records. The letter closed
the file on this matter, stating that the EPA complied with the requirements
governing the reporting of allegations of possible loss of federal records.
We also attempted to obtain access to the retired employee's personal email
records regarding Bristol Bay activities because we found that the employee had
used personal email to review the draft petition. We issued a subpoena to the
former employee's legal counsel, as we could not identify the former employee's
location. The former employee's legal counsel refused service, stating that she
was not authorized to accept service on behalf of her client.
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Chapter 2
EPA's Bristol Bay Watershed Assessment
Events That Led to EPA's Decision to Conduct the Bristol Bay
Watershed Assessment
From 2007 through 2010, EPA representatives participated in technical working
groups with PLP. One EPA participant was the EPA Region 10 GS-13 Ecologist
based in Alaska whose responsibilities included conducting CWA Section 404
permit reviews and enforcement, wetland monitoring and assessment, and grants
management; and general outreach and collaboration with federal, state, local and
tribal partners on wetlands protection and restoration. This Region 10 employee—
who had retired effective April 30, 2013—told us that he initiated discussions
with his supervisor and EPA managers on the possible use of CWA Section
404(c) for the Pebble Mine project based on his job duties listed in his
performance standards and his experience with mining.
The CWA Section 404(c) process could restrict, prohibit, deny or withdraw the
use of an area as a disposal site for dredged or fill material. Discussions were
initiated prior to the receipt of a May 2010 tribal petition. The idea to use CWA
Section 404(c) eventually was briefed to, and considered by, the Region 10
Administrator and the then EPA Administrator Lisa Jackson. In January 2010,
EPA staff briefed then Administrator Jackson on the proposed Pebble Mine
project and various options for EPA involvement, with one option being a CWA
Section 404(c) process.
On May 21, 2010, the EPA received a petition from six federally recognized tribal
governments requesting that the EPA initiate a CWA Section 404(c) process to
identify wetlands and waters in the Kvichak and Nushagak river drainages where
discharges associated with potential large-scale mining could be prohibited or
restricted. Following this letter, three additional federally recognized tribal
governments signed on to this letter. The EPA also received letters from multiple
stakeholders expressing their interest and concerns regarding potential EPA action
to protect Bristol Bay fishery resources. Some requests favored immediate action
to comprehensively protect Bristol Bay via any tools available, including CWA
Section 404(c). Others favored a targeted CWA Section 404(c) action that would
restrict only mining associated with the Pebble deposit. These stakeholders
included additional tribes, other tribal organizations and others.
Also in 2010, the EPA received requests to refrain from taking action under
CWA Section 404(c). These requests included those that asked for more time to
understand potential implications of mine development in the Bristol Bay
watershed, and others that requested that the EPA wait until formal mine permit
applications had been submitted and an environmental impact statement
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developed. These stakeholders included federally recognized tribal governments,
other tribal organizations, the Governor of Alaska, and attorneys representing
PLP.
In June 2010, EPA staff presented a briefing on the proposed Pebble Mine project
to the EPA Region 10 Administrator. In August 2010, EPA staff gave a
presentation to the then Deputy Assistant Administrator for Water and a
presentation to the then Senior Policy Counsel to the Administrator. The
presentation for the then Senior Policy Counsel included discussion of future
options, including a possible CWA Section 404(c) process.
We found that there were discussions within the EPA prior to the assessment
regarding the following three options on how to respond to the requests:
1.	Take no action under CWA Section 404(c) at that time.
2.	Initiate the CWA Section 404(c) process ("intent to issue notice of
proposed determination").
3.	Gather additional scientific information through a public process.
Some in Region 10 believed that option 1 was the best way to respond to requests,
while others believed option 2 was the best response.7 In November 2010, another
briefing was given to then EPA Administrator Jackson, during which option 3
was recommended. On February 7, 2011, the Region 10 Administrator issued a
news release announcing the agency's decision to conduct the ecological risk
assessment. The assessment—a collaboration among EPA Region 10, OW and
ORD—sought to determine the significance of Bristol Bay's ecological resources
and evaluate the potential impacts of large-scale mining on those resources.
According to the EPA, since some of the requests specifically referenced the use
of CWA Section 404(c), it was expected that this scientific information-gathering
effort would provide a base of information for any agency decision on whether to
use CWA Section 404(c), either immediately or in the future.
After the announcement, the EPA formed an Intergovernmental Technical Team
of federal, state and tribal governmental representatives to provide opportunities
to contribute and review information. The purpose of the team was to bring
together experts with scientific and traditional ecological knowledge who could
7 We obtained an EPA Office of Water budget document entitled "FY11 Proposed Investment: Bristol Bay 404(c)"
that, according to OW's principal technical lead on Bristol Bay, was developed in November or December 2010 to
inform funding priority discussions taking place within OW. This document states, "Region 10 believes that
additional information gathering and analysis must be completed in order to support a decision to formally initiate
[a] 404(c). It's still possible that a veto will not prove necessary, but a decision to move forward has created the need
for upfront analysis and outreach regardless." According to the OW technical lead, at the time the budget document
was developed, the agency had not yet decided how it would proceed. In the event that an option with an expedited
schedule was selected, this budget document estimated potential immediate funding needs. The OW technical lead
said that this document was used internally within OW, and was not used to request funding from the Administrator.
The OW technical lead also said that all budget documents were revised once a version of option 3 was selected.
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provide input on the collection and evaluation of scientific and technical
information for the assessment.
Issuance of EPA's Bristol Bay Watershed Assessment
In May 2012, the EPA issued its initial draft assessment for public review and
comment and received approximately 233,000 comments. In seeking public
comment on this draft, the EPA held eight public meetings. After the issuance of
the initial draft assessment, an external peer review was also conducted,
consisting of a panel of 12 scientific experts. In April 2013, the EPA issued its
revised draft assessment for public review and comment and received
approximately 890,000 comments. The EPA also reconvened the 12 scientific
experts to evaluate whether the revised draft responded to the experts' comments
on the initial draft assessment.
On January 15, 2014, the EPA published the final assessment. According to the
EPA, the assessment did not reflect any conclusions or judgments about the need
for or scope of potential government action, nor did it offer or analyze options for
future decisions. Rather, it was intended to provide a characterization of the
biological and mineral resources of the Bristol Bay watershed, increase
understanding of the risks from large-scale mining to the region's fish resources,
and inform future government decisions. Throughout the process, the EPA also
consulted with tribal governments in the Bristol Bay area. According to the EPA,
they invited all 31 federally recognized tribes in the area to consult with them, and
20 tribes participated in these tribal consultations.
EPA Issued Notice of Intent to Make a CWA Section 404(c)
Determination
On February 28, 2014, the Region 10 Administrator sent a letter to the U.S. Army
Corps of Engineers, the state of Alaska, and PLP stating the agency's intent to
proceed under its CWA Section 404(c) regulations to review potential adverse
environmental effects of discharges of dredged and fill material associated with
mining the Pebble deposit. According to the EPA, it based this action on available
information, including data collected as a part of the agency's assessment, mine
plans submitted to the U.S. Securities and Exchange Commission, and materials
provided by PLP. The EPA also said this action was in response to petitions from
the public.
On July 18, 2014, EPA Region 10 issued a proposed determination to restrict the
use of certain waters in the Bristol Bay watershed for disposal of dredged or fill
material associated with mining the Pebble deposit. The EPA received about
670,000 public comments on its proposed determination. In August 2014, the
EPA held seven public hearings in Alaska on its proposed determination.
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In November 2014, a federal judge in Alaska issued a preliminary injunction,
based on allegations related to the Federal Advisory Committee Act, stopping the
EPA from continuing with its CWA Section 404(c) process. If the injunction is
lifted, the Region 10 Administrator can either withdraw the proposed
determination or prepare a recommended determination. As of January 11, 2016,
the injunction was still in place and a recommended determination had not been
issued, nor had the proposed determination been withdrawn.
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Chapter 3
Obtainable Records Showed No Evidence of Bias or
Predetermination, and EPA Followed Policies and
Procedures While Conducting Assessment
Obtainable records showed no evidence of bias in how the EPA conducted the
Bristol Bay watershed assessment or that the EPA predetermined the outcome of
the assessment to result in initiating a CWA Section 404(c) process. Also,
regarding allegations that the assessment did not follow requirements for
ecological risk assessments, peer review and information quality, we found that:
•	The assessment included sections on the three primary phases discussed in
the agency's ecological risk assessment guidelines.
•	The EPA followed recommended EPA and Office of Management and
Budget (OMB) procedures for peer review of highly influential scientific
assessments (HISAs).8
•	The EPA followed agency policies and guidance for reviewing and verifying
the quality of information in the assessment before its release to the public.
Obtainable Records Showed No Evidence of Bias or Predetermination
Related to How EPA Conducted Assessment
Based on available information, interviews, and review of emails we were able to
obtain, we found no evidence of bias in how the EPA conducted the assessment.
We also found no evidence that the EPA predetermined the outcome of the
assessment to initiate a CWA Section 404(c) process in the Bristol Bay
watershed. There were EPA staff and managers who were considering a CWA
Section 404(c) process prior to the EPA's official announcement to conduct the
assessment, but we did not uncover any evidence of a predetermined outcome in
any of the documents or emails we reviewed or interviews we conducted.
EPA Addressed Guidelines on Risk Assessment, and Followed
Procedures on Peer Review and Information Quality
Ecological Risk Assessment
The EPA's Guidelines for Ecological Risk Assessment (1998) define ecological
risk assessment as a process that evaluates the likelihood that adverse ecological
8 A scientific assessment is considered "highly influential" if the agency or OMB's Office of Information and
Regulatory Affairs determines that the dissemination could have a potential impact of more than $500 million in any
1 year on either the public or private sector or that the dissemination is novel, controversial, precedent-setting, or has
significant interagency interest.
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effects may occur or are occurring as a result of exposure to one or more stressors.
The guidelines note that the EPA designs and conducts ecological risk
assessments to provide information to risk managers about the potential adverse
effects of different management decisions. We found that the Bristol Bay
watershed assessment included sections on the three primary phases discussed in
the agency's ecological risk assessment guidelines, and Table B-l in Appendix B
includes our analysis of how the assessment addressed each phase.
Peer Review
The EPA's 2006 peer review policy states that the EPA strives to ensure that the
scientific and technical bases of its decisions are based upon the best current
knowledge and that they are credible. The policy notes that peer review—
a process based on the principles of obtaining the best technical and scientific
expertise with appropriate independence—is central to sound science. The EPA
requires peer review of all scientific and technical information intended to inform
or support agency decisions. The EPA's peer review policy further requires that
influential scientific information, including HISAs such as the Bristol Bay
assessment, be peer reviewed in accordance with the agency's Peer Review
Handbook. We found that the following peer review work was conducted
regarding the Bristol Bay watershed assessment.
Primary Review. The EPA tasked a contractor with conducting an external
peer review of the agency's May 2012 draft assessment. In the performance
work statement, the EPA required that the contractor's work be in compliance
with the EPA Peer Review Handbook. The contractor assembled a 12-member
external panel of reviewers in such fields as mine engineering, salmon
fisheries biology and Alaska native cultures. The contractor conducted an
external peer review panel meeting August 7-9, 2012, and invited the public
to provide oral testimony during the first day. As part of the peer review, the
panel had access to public comments received during the public comment
period following release of the May 2012 draft assessment, as well as oral
comments made during the August 2012 peer review meeting. The same
12 external peer reviewers conducted a follow-on peer review of the EPA's
April 2013 revised draft assessment, and the EPA provided another 60-day
public comment period following the release of the April 2013 draft
assessment.
Supplemental Review. During public comment on the May 2012 draft, the
EPA received feedback on additional technical reports to consider for the final
assessment, seven of which the EPA identified as relevant and potentially
useful to the assessment. Because the seven suggested reports had not been
peer reviewed, the EPA arranged for the same contractor to conduct a
supplemental "letter" peer review of each report in November and
December 2012. The contractor selected 15 reviewers, two of whom were also
on the external peer review panel for the May 2012 draft. The EPA ultimately
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cited five of the seven supplemental reports in the final assessment. The EPA
did not cite the other two reports due to questions concerning their quality and
the reputation and objectivity of one of the coauthors of the two reports.
Tables in Appendix B show our analysis that the EPA followed OMB (Table B-2)
and agency (Table B-3) requirements during the primary and supplemental peer
reviews—specifically for HISAs, transparency and conflict of interest.
In addition, we sought perspectives from all 12 external peer reviewers on the
EPA's peer review process. We received responses to our questions from 11 of
the 12 external peer reviewers. Overall, they found the process sufficient.
Reviewers stated they had either no or very limited contact with the EPA. Table 1
below notes additional responses.
Table 1: External peer reviewer responses
OIG Questions
Res
ponses
No
Yes
Found the EPA's charge questions to be appropriate.
1
10 (91%)
Found the peer review schedule to be appropriate given the
scope/charge.
1
10 (91%)
Found that the process included adequate opportunities for
public involvement.
0
10 (100%)9
Found the external peer review panel was balanced in terms
of reviewer expertise.
0
11 (100%)
Thought the EPA adequately addressed external peer review
comments.
1
10 (91%)
Source: OIG summary of information obtained from 11 external peer reviewers.
All three "no" responses were provided by the same peer reviewer. This reviewer
thought the charge questions were confining in terms of scope and that the EPA
might have received broader viewpoints had charge questions not been so
limiting. The reviewer also felt that the peer review schedule did not provide
enough time initially to review the assessment and provide comments. The
reviewer also did not believe the EPA fully addressed his comments on the first
draft, although the reviewer could not recall specific comments he felt went
unaddressed. The reviewer said he raised concerns to the EPA on the
supplemental papers described above and that the EPA did not follow the usual
peer review process on the supplemental papers. According to ORD, it has no
"usual" process for conducting peer reviews of non-agency reports. No other peer
reviewers expressed these concerns.
Information Quality
We found that the EPA followed policies and guidance for reviewing and
verifying the quality of information in the assessment before its release. ORD
accomplished this through its quality assurance, peer review and clearance
9 One of the 11 did not provide a response to this question.
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processes. Peer review (discussed above) is a major element of how ORD directly
addresses the question of whether the type, quantity and quality of the data and
information used in assessments are appropriate for their intended use.
The EPA hired a contractor to perform environmental data analyses related to the
baseline condition of the Bristol Bay watershed, potential mining scenarios, and
fisheries; and to do a predictive risk assessment for the effects of mining on
salmon and non-salmon fish. The ORD required this contractor to develop two
quality assurance project plans (QAPPs)—one for the draft report and one for the
final. The EPA's quality policy requires that all environmental data used in
decision making be supported by an EPA-approved QAPP. This applies to both
EPA offices and contractors. The QAPP provides a project-specific "blue-print"
for obtaining the type and quality of environmental data needed for a specific
decision or use.
Both QAPPs developed for the Bristol Bay watershed assessment included all
necessary elements from the EPA Requirements for Quality Assurance Project
Plans (2001, re-issued 2006). These requirements include basic information
(e.g., what the quality assurance activities are and who is responsible) as well as
what standards will be used to evaluate the data used or produced. For example,
the QAPP for the final report identifies how and by whom the initial, technical
and quality assurance reviews of analyses and final products will occur. The
QAPP for the draft report also includes copies of the contractor's standard
operating procedure for conducting literature searches for technical data,
acceptance factors, and guidelines for evaluating secondary data.
Both QAPPs for the assessment were approved by the EPA's Quality Assurance
Managers in accordance with the ORD's National Center for Environmental
Assessment Quality Management Plan (2007, 2013). Under the EPA Requirements
for Quality Assurance Project Plans, the contractor was responsible for oversight
and implementing the quality assurance activities in the EPA-approved QAPPs for
the assessment. We did not review contractor oversight or implementation.
For HISAs such as the Bristol Bay assessment, the EPA followed the appropriate
ORD Quality Management Plan clearance processes before releasing the draft and
final reports to the public. The final assessment report includes both a cautionary
statement about using report data for other than its intended purpose (Chapter 1)
and a readily identifiable section (Chapter 14) that discusses data quality and
limitations as required by the EPA Quality Manual for Environmental Programs
(2000). In addition, the final assessment incorporates the five elements that the
EPA's Information Quality Guidelines (2002)10 recommend, including in any
final influential scientific risk assessment that is presented to the public. See
Table B-4 in Appendix B for our analysis.
10 EPA Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information
Disseminated by the Environmental Protection Agency (October 2002).
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Chapter 4
Possible Misuse of Position May Have Occurred
Prior to the Assessment
We found an instance in which an EPA Region 10 employee used his personal
nongovernmental email to review and provide comments on a draft CWA Section
404(c) petition from tribes before they submitted it to the EPA. This action is a
possible misuse of position under the Standards of Ethical Conduct for Employees
of the Executive Branch. Whether the employee's actions resulted in an actual
misuse of position depends on other considerations that we were unable to
discern. The employee's supervisor told us that he was not aware that the
employee had taken such action and he would not have allowed the employee to
interact the way he did. The supervisor thought it inappropriate that the employee
would review a draft petition that the agency could later act upon.
Possible Misuse of Position by EPA Employee Involved With Petition
Prior to six federally recognized tribes submitting their petition to the EPA on
May 21, 2010, an attorney representing the tribes sent a draft version of the
petition, along with other documents, to a Region 10 GS-13 Ecologist's personal
email, and asked him to review it. This retired employee, at a staff level, was
responsible for implementing and overseeing CWA provisions for portions of
Alaska and was one of 20 authors of, and an EPA technical lead for, the
assessment. This petition requested that the EPA initiate a CWA Section 404(c)
process in the Bristol Bay watershed.
The tribal attorney sent the petition in an email to the EPA Region 10 employee's
nongovernmental personal email account on January 8, 2010. The attorney again
sent it on March 1, 2010, and March 11, 2010. On March 11, 2010, the Region 10
employee replied using his personal email saying he would look it over. The
attorney again emailed the petition to the Region 10 employee on April 11, 2010.
On April 12, 2010, using his personal email, the Region 10 employee replied to
the attorney with suggested edits to the tribes' CWA Section 404(c) petition
letter.11 The Region 10 employee provided six edits on word choice and one
comment to add some language on ecological effects not directly related to
fisheries. The final tribal petition letter sent to then EPA Administrator Jackson
included changes suggested by the Region 10 employee.
The agency did not receive the petition from the tribes requesting that the EPA
take CWA Section 404(c) action until May 21, 2010. While reviewing the
Region 10 employee's official EPA emails, we found that he forwarded the initial
11 We also found an instance where this Region 10 employee was informed by another external party, via email to
his EPA work email dated April 14, 2010, that a CWA Section 404(c) action request would be coming to the EPA.
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email from the attorney dated January 8, 2010, to his EPA work email address on
July 7, 2010. However, we found no evidence that the Region 10 employee
forwarded the email in which he provided edits to his EPA work email account.12
There is no requirement in the CWA or the EPA's regulations pertaining to a
process for petitions for CWA Section 404(c). According to OW staff, letters and
petitions requesting that the EPA initiate a CWA Section 404(c) action are entered
into the agency's Correspondence Management System. OW staff said that this
petition from the tribes followed this process.
As set forth in the Standards of Ethical Conduct for Employees of the Executive
Branch,13 employees shall not use their public office for their own private gain or
for the gain of those with whom they are affiliated in a nongovernmental capacity,
and shall endeavor to avoid any actions creating the appearance that they are
violating the law or the ethical standards. Whether particular circumstances create
an appearance that the law or these ethical standards have been violated shall be
determined from the perspective of a reasonable person with knowledge of the
relevant facts.
The Region 10 employee's job duties included providing advice and assistance to
tribal governments on matters relating to the development, execution and
monitoring of environmental protection policies, plans and programs. According
to the EPA, this person was the only EPA employee working from a small office
remotely located in Alaska, where telecommunication challenges occasionally
required the employee to conduct EPA work using his personal email account.
When reviewing the draft petition, it was not clear whether the Region 10 employee
participated in a personal or official capacity. It was also not clear whether
commenting on the draft petition using personal email was allowable under the job
duties of the Region 10 employee. The employee's supervisor stated that while the
employee was allowed to talk with tribes and interact with them based on his
responsibilities, the supervisor did not approve the employee's action to review and
comment on the draft petition. In fact, the supervisor stated that the employee never
asked if he could review the petition, so the supervisor was unaware that the
employee reviewed it. The supervisor told us that he would not have allowed the
employee to interact with an external attorney in this manner and said that it seems
inappropriate that the employee would review a draft petition that the agency could
later act upon. As discussed in Chapter 2, the EPA decided to conduct the assessment
instead of initiating the CWA Section 404(c) process in 2011.
12	Other than the January 8, 2010, email, the other emails discussed in this section were provided to us by an
attorney who represented the six federally recognized tribes. As mentioned in Chapter 1, Scope Limitations, we
attempted to obtain access to this employee's personal email records but were unable to legally obtain access. We do
not know if this instance is isolated.
13	The U.S. Office of Government Ethics published the standards on August 7, 1992, and the regulation became
effective on February 3, 1993.
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We also asked various other EPA officials involved with the assessment if they
were aware that the Region 10 employee had reviewed the draft petition. In all
cases, EPA officials said that they were not aware of it until we brought it to their
attention. Region 10's Regional Counsel stated that staff interacting with tribes
are not always aware of the boundaries with tribes when staff seek to meet
government-to-government trust responsibilities.
We found no evidence that any law was violated, but possible misuse of position
did result from the Region 10 employee's actions. The EPA's Senior Counsel for
Ethics agreed that this was a possible misuse of position. Whether the employee's
actions resulted in an actual misuse of position depends on other considerations
that we were unable to discern because we could not access all of the employee's
work emails and nearly all personal emails of the employee. In addition, although
we interviewed the former Region 10 employee after his retirement, we were
unable to ask any questions related to this issue as we had not uncovered the issue
at the time of the interview. As we do not know the current location of the former
employee, we contacted the employee's legal counsel to see if the employee
would answer additional questions, but did not receive a response from the legal
counsel. We were also unable to discern specific distinctions in the employee's
job duties as they relate to communication with and assistance to tribal
governments. As this employee is retired, no administrative action can be taken.
Conclusion
We found that an EPA Region 10 employee used personal nongovernmental
email to provide comments on a draft CWA Section 404(c) petition from tribes
before they submitted it to the EPA. This action was a possible misuse of position.
Agency employees must remain impartial in dealings with outside parties,
particularly those that are considering petitioning or have petitioned the agency to
take action on a matter.
Recommendations
We recommend that the Principal Deputy General Counsel in the Office of
General Counsel—the EPA's Designated Agency Ethics Official:
1.	Incorporate in the EPA's ethics training examples of misuse of position in
interactions with stakeholders related to the OIG's findings in this report.
We recommend that the Assistant Administrator for International and Tribal Affairs:
2.	Work with the EPA's Designated Agency Ethics Official (the Principal
Deputy General Counsel) to define appropriate and ethical parameters of
tribal assistance and include that in EPA's mandatory tribal training.
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We recommend that the Regional Administrator, Region 10:
3. Issue a memo to Region 10 staff emphasizing the importance of adhering to
the Standards of Ethical Conduct for Employees of the Executive Branch,
particularly when dealing with external parties with an interest in
requesting or petitioning the EPA to take regulatory or administrative
action.
Agency Comments and OIG Evaluation
On November 10, 2015, the agency provided a coordinated response to our draft
report on behalf of Region 10, the Office of International and Tribal Affairs, the
Office of General Counsel, the Office of Water, and the Office of Research
Development (see Appendix C). The agency agreed with all three
recommendations and proposed adequate corrective actions. While the EPA did
not initially provide a date in its response for taking action on Recommendation 2,
we followed up with the agency and the agency subsequently provided a
satisfactory date of November 2016 for taking the corrective action.
The agency also provided technical comments on the draft report. Where
appropriate, we incorporated changes to the report based on the agency's
technical comments.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
POTENTIAL MONETARY
BENEFITS (In $000s)
Rec. Page
No. No.
Subject
Status1
Action Official
Planned
Completion
Date
Claimed
Amount
Ag reed-To
Amount
17 Incorporate in the EPA's ethics training examples
of misuse of position in interactions with
stakeholders related to the OIG's findings in this
report.
17	Work with the EPA's Designated Agency Ethics
Official (the Principal Deputy General Counsel) to
define appropriate and ethical parameters of tribal
assistance and include that in EPA's mandatory
tribal training.
18	Issue a memo to Region 10 staff emphasizing the
importance of adhering to the Standards of Ethical
Conduct for Employees of the Executive Branch,
particularly when dealing with external parties with
an interest in requesting or petitioning the EPA to
take regulatory or administrative action.
Principal Deputy General 10/31/16
Counsel, Office of General
Counsel
Assistant Administrator for 11/30/16
International and Tribal
Affairs
Regional Administrator, 1/31/16
Region 10
1 0 = 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.
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Appendix A
Details on Scope and Methodology
The overall objective of our review was to determine whether the EPA adhered to laws,
regulations, policies and procedures in developing its assessment of potential mining impacts on
ecosystems in Bristol Bay, Alaska. Specifically, we addressed:
•	The reason the EPA conducted the assessment and whether there was any evidence that
the EPA conducted the assessment in a biased manner or it had a predetermined outcome.
•	Whether the EPA followed ecological risk assessment policies and procedures when
conducting the assessment.
•	Whether the EPA followed peer review policies and procedures.
•	Whether the EPA followed the Information Quality Act and related policies and
procedures.
We reviewed the processes used to conduct the assessment, not the scientific content. The EPA
began its assessment in February 2011 and issued its final assessment report in January 2014.
Our review encompassed this entire timeframe and the time leading up to the decision to conduct
the assessment.
Documents and Interviews
We reviewed the following criteria documents:
•	Clean Water Act Sections 104(a) and (b) and 404(c).
•	Key materials on EPA's Bristol Bay website, including:
o EPA's final watershed assessment, An Assessment of Potential Mining Impacts on
Salmon Ecosystems of Bristol Bay, Alaska (January 2014).
o EPA's Proposed Determination of the U.S. Environmental Protection Agency
Region 10 Pursuant to Section 404c of the Clean Water Act, Pebble Deposit Area,
Southwest Alaska (July 2014).
•	Ecological risk assessment guidance, including the EPA's:
o	Training materials on watershed ecological risk assessment,
o	Framework for Ecological Risk Assessment (February 1992).
o	Guidelines for Ecological Risk Assessment (April 1998).
o	Framework for Cumulative Risk Assessment (May 2003).
o	Guidance for Risk Characterization (February 1995).
o	Risk Characterization Handbook (December 2000).
•	Peer review guidance, including:
o OMB's Final Information Quality Bulletin for Peer Review (December 2004).
o EPA's Peer Review Policy (January 2006).
o EPA's Peer Review Handbook 3rd Edition (December 2009).
o EPA's conflict of interest review process for contractor-managed peer reviews of
highly influential scientific assessments (March 2013).
o ORD Policies and Procedures Manual (September 1995).
•	Information quality guidance, including:
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o The Information Quality Act (2000).
o EPA's Quality Policy (2008), Procedure for Quality Policy (2008), quality
management and quality assurance project plans and additional guidance
documents.
o EPA Quality Manual for Environmental Programs (2000).
o EPA's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility,
and Integrity of Information Disseminated by the Environmental Protection
Agency (2002).
o EPA Requirements for Quality Assurance Project Plans (2001, re-issued 2006).
•	Tribal policies and procedures, including:
o Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments (November 2000).
o EPA Policy for the Administration of Environmental Programs on Indian
Reservations (November 1984).
o EPA Policy on Consultation and Coordination with Indian Tribes (May 2011).
o EPA Region 10 Tribal Consultation and Coordination Procedures (October 2012).
•	Ethics and scientific integrity guidance, including:
o U. S. Office of Government Ethics Standards of Ethical Conduct for Employees of
the Executive Branch (July 2011).
o EPA's Scientific Integrity Policy (enacted February 2012).
o White House guidance on scientific integrity (issued in March 2009) and
implementing guidance from the Office of Science and Technology Policy
(December 2010).
•	Relevant prior OIG reports and testimony before the House Committee on Science,
Space and Technology, and House Committee on Natural Resources.
•	Materials from PLP.
We interviewed:
• EPA staff and managers in:
o Region 10
¦	Regional Administrator and Deputy Regional Administrator.
¦	Technical Lead for the Assessment
¦	Personnel within the Regional Counsel's Office; the Office of Ecosystems,
Tribal and Public Affairs; and the Alaska Operations Office.
¦	Retired employees, including the former project manager for Bristol Bay,
regional mining coordinator, and an ecologist.
o OW
¦	Former acting Assistant Administrator.
¦	Technical Lead for the assessment.
¦	Chief of Staff.
¦	Assistant to the Chief of Staff.
¦	Staff from the Office of Wetlands, Oceans and Watersheds,
o ORD
¦	Principal Technical Lead for the assessment.
¦	Principal Investigator for the assessment.
¦	Peer Review Leader.
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¦	Peer Review Coordinator and Quality Assurance Manager,
o Administrator's Office
¦	Deputy Chief of Staff.
¦	Former Senior Policy Counsel to the Administrator,
o Office of General Counsel
¦	Senior Counsel for Ethics.
•	Three external peer reviewers of the draft Bristol Bay watershed assessment
(obtained responses via email from the other nine).
•	Chief Executive Officer for PLP.
•	Alaska Attorney General and Assistant Attorney General.
•	Former legal counsel to Alaska Native tribes that petitioned the EPA to take CWA
Section 404(c) action.
•	Tribal representatives of the United Tribes of Bristol Bay and from Alaska Native
Corporations (Iliamna Development Corporation and Alaska Peninsula Corporation).
•	Members of the Intergovernmental Technical Team from the U.S. Fish and Wildlife
Service, National Oceanic and Atmospheric Administration, and National Park Service.
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Appendix B
Analysis of Assessment's Adherence to
Procedures for Ecological Risk Assessment,
Peer Review and Information Quality
Table B-1: Ecological risk assessment phases addressed in the Bristol Bay watershed assessment
Phase
Procedural guidance and OIG analysis
1. Problem
Formulation
This phase results in three products: (1) assessment endpoints14 that
adequately reflect management goals and the ecosystem they represent,
(2) conceptual models that describe key relationships between a stressor15 and
assessment endpoint, and (3) an analysis plan.
The assessment included sections on the three primary phases discussed in
this guidance. The assessment has two main sections, one of which is problem
formulation (Chapters 2-6). While the EPA did not develop separate
assessment endpoint and analysis plan documents, the EPA described
endpoints in Chapter 5 and the analysis plan throughout problem formulation in
Chapters 2-6. EPA OW and ORD staff said they focused the assessment on
the endpoint of large-scale porphyry copper mining effects on salmon
fisheries.16 The EPA worked with the individual participants on the
Intergovernmental Technical Team to scope the assessment by developing and
updating a conceptual model17 based on input from team participants. Chapter
6, Section 6.4, summarizes this model. The EPA met with several stakeholders
as the agency formulated the assessment, including PLP and tribal interests.
2.	Analysis
3.	Risk
Characterization
Analysis examines risk, exposure and effects, and their relationships between
each other and ecosystem characteristics. Risk characterization clarifies these
relationships to reach conclusions on the occurrence of exposure and the
adversity of existing or anticipated effects.
The assessment included sections on the three primary phases discussed in
this guidance. The assessment has two main sections, one of which is risk
analysis and characterization (Chapters 7-14). We evaluated the assessment
against the EPA's "Risk Characterization Handbook" (2000) and met with EPA
ORD's Principal Technical Lead and Principal Investigator and discussed
whether the assessment met the 12 elements18 of risk characterization listed in
the handbook. They described how the assessment met 11 of 12 elements.
They said that the remaining element ("policy choices") was not required
because the assessment was not a decision document. We believe the EPA's
responses were adequate.
Source: OIG analysis.
14	The EPA's "Guidelines for Ecological Risk Assessment" (1998) defines endpoints as "explicit expressions of the
actual environmental value that is to be protected, operationally defined by an ecological entity (e.g., a species,
community, or ecosystem) and its attributes."
15	In the assessment, the EPA defines stressors as "physical or chemical entities that may directly induce a response
of concern."
16	In the assessment, the EPA said one endpoint was the "abundance, productivity, or diversity of the region's
Pacific salmon and other fish populations."
17	A conceptual model is a written description and a visual representation of predicted relationships between
ecological entities and the stressors to which they may be exposed.
18	The 12 elements are: (1) key information; (2) context, (3) sensitive subpopulations, (4) scientific assumptions,
(5) policy choices, (6) variability, (7) uncertainty, (8) bias and perspective, (9) strengths and weaknesses, (10) key
conclusions, (11) alternatives considered, and (12) research needs.
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Table B-2: Adherence to OMB's "Final Information Quality Bulletin for Peer Review"
Procedural requirement
OIG analysis
Ensure transparency by making available to
the public the charge to peer reviewers; the
peer reviewers' names; the peer reviewers'
reports; and the agency's response to the peer
reviewers' reports.
Primary: Via Federal Register notice, the EPA
provided public comment periods of 14 and 21 days,
respectively, for the nominations of peer review
panelists and the EPA's charge questions to
reviewers. The EPA made peer reviewers' names
publicly available in various sources, and the
agency's archived Science Inventory website
included both the peer review report and the
agency's response.
Supplemental: The EPA did not publicly announce
that supplemental peer review took place until the
EPA released the April 2013 draft assessment, at
which time the agency publicly released the peer
reviewer's reports along with the reviewed reports
themselves. ORD's Principal Technical Lead said
that public disclosure and comment were not needed
because the reports were not agency products and
the decision to use them as part of the assessment
had yet to be made. He said the assessment team
wanted input from technical reviewers to assess
whether the reports were based upon good science
and, if not, understand any potential limitations
associated with the documents.
Provide a link to the peer review reports on the
Science Inventory website.
Met for both the primary and supplemental
reviews.
Include the review in the Peer Review Agenda
for HISAs (Science Inventory).
Met for both the primary and supplemental
reviews.
Prepare and post on the Science Inventory a
written response to the peer review report
explaining the agency's agreement or
disagreement with the views expressed; the
actions undertaken to respond to the report;
and the reasons the agency believes those
actions satisfy any key concerns.
Primary: The EPA released "response to comments"
reports following the May 2012 and April 2013 drafts.
Each "response to comments" report included a
summary of the comment made, the source of the
comment, the EPA's response (agree/disagree), and
any changes in the draft to address the comment.
Supplemental: While the Science Inventory site
contains the seven reports and the "letter" peer
reviewer's comments on each, the site does not have
any EPA "response to comments" on the agency's
agreement or any actions as a result of the
comments. ORD's Principal Technical Lead said that
the EPA did not cite the supplemental reports until
peer reviews showed that the data cited were sound.
Source: OIG analysis.
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Table B-3: Adherence to EPA's "Peer Review Handbook"
Procedural requirement
OIG analysis
Conduct an external peer review and list names
and affiliations of reviewers in the peer review
report.
Met for both the primary and supplemental
reviews.
Ensure that charge questions meet essential
elements of a charge.
Met for both the primary and supplemental
reviews.
For a contractor-managed review, ensure that
EPA:
•	Obtains stakeholder input and provides the
list of charge questions to the contractor.
•	Reviews the contractor's list of potential
reviewers for conformance to work
assignment specifications and any conflicts
of interest.
•	Ensures that the Statement of Work
addresses conflict of interest as a matter
bound by contractual clause.
•	Ensures that the conflict of interest inquiry
took place and appears in the peer review
record.
•	Provides background material to the
contractor to distribute to peer reviewers
(i.e., the EPA limits direct contact to the
contractor's designated representative and
does not have general contact with the
contractor's staff or peer reviewers).
Primary: The EPA had a 21-day public comment
period for the charge questions prior to the EPA
distributing the questions to the contractor. EPA
ORD reviewed the contractor's list of external peer
reviewers' qualifications and potential conflicts of
interest, and the contractor narrowed the list of
candidates based on the EPA's review. The
contractor's Statement of Work included specific
tasks and deliverables on conflict of interest, and
EPA ORD's Peer Review Leader ensured that the
conflict of interest inquiry took place before review
of both the first and second extramural review
drafts, and that it was documented in the peer
review record. The Statement of Work noted that
the contractor was to distribute documents to
reviewers. It also required limited engagement
between the EPA and reviewers at the public peer
review meeting (except for minor clarifications) to
prevent the EPA from biasing or influencing
reviewers' discussions. Further, the peer review
report described what background materials the
contractor provided to reviewers.
Supplemental: The EPA met all of the procedural
requirements except for obtaining stakeholder input
on the charge questions. As noted in Table B-2
above, the EPA did not publicly announce the
supplemental peer review until after it had been
completed. ORD's Principal Technical Lead said
that public disclosure and comment were not
needed because the reports were not agency
products and the decision to use them as part of the
assessment had yet to be made.
Source: OIG analysis.
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Table B-4: EPA's recommended elements for presenting influential risk assessment information
Information quality element
OIG review of the final assessment report
1
Each population addressed by any
estimate of applicable human health risk or
each risk assessment endpoint, including
populations if applicable, addressed by any
estimate of applicable ecological risk.
Chapter 5 states the EPA considered three endpoints
in this assessment: (1) the abundance, productivity
or diversity of the region's Pacific salmon and other
fish populations; (2) the abundance, productivity or
diversity of the region's wildlife populations; and
(3) the health and welfare of Alaska Native cultures.
2
Expected risk or central estimate of human
health risk for the specific populations
affected or the ecological assessment
endpoints.
Chapter 5 states that expected risks to salmon and
other fish populations are evaluated in terms of direct
effects of mining on habitat. Chapters 12 and 13
explain that "data are insufficient to predict wildlife
population impacts"; as a result, the report
qualitatively considers impacts via the loss of both
salmon as a food source and marine-derived
nutrients as a source of productivity.
Chapter 12 says that for Alaska Native cultures, the
initial effect of a mine accident or failure would be the
loss or decrease of subsistence and salmon
resources downstream; the magnitude of
subsistence loss or geographic disruption cannot be
quantified. Chapter 13 provides examples of
subsistence uses offish and wildlife potentially
affected for each mining scenario described in the
report.
3
Each appropriate upper-bound or lower-
bound estimate of risk.
For salmon and other fish, Chapter 13 estimates risk
in terms of potential direct losses in habitat: between
43.2km (lower-bound) and 69.5km (upper-bound) of
streams; 1.28km2 (lower-bound) and 2.06 km2
(upper-bound) of water bodies; and 7.9km2 (lower-
bound) and 27.1km2 (upper-bound) of wetlands.
The report states that it only considers indirect
impacts for wildlife and Alaska Native cultures due to
insufficient data. As a result, the risk cannot be
quantified by upper- and lower-bound estimates for
wildlife and Alaska Native cultures.
4
Each significant uncertainty identified in
the process of the assessment of risk and
studies that would assist in resolving the
uncertainty.
Chapter 14, "Integrated Risk Characterization,"
identifies and describes uncertainties for the overall
assessment and the mine designs and scenarios
used. Sections within the individual chapters also
address any significant uncertainties associated with
that specific element of the assessment.
5
Peer-reviewed studies that support, are
directly relevant to, or fail to support any
estimate of risk and the methodology used
to reconcile inconsistencies in the scientific
data.
Chapter 15: References list all source documents
used and organized by report chapter. Generally, the
references used in the assessment report were either
internally or externally peer reviewed.
Source: OIG analysis.
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Appendix C
Agency Response to Draft Report
[November 10, 2015]
MEMORANDUM
SUBJECT: Response to Office of Inspector General Draft Report No. OPE-FY14-0039
"EPA's Bristol Bay Watershed Assessment: Obtainable Records Show EPA
Followed Required Procedures Without Bias or Predetermination, But Possible
Misuse of Position Noted," dated October 26, 2015
FROM: Kevin Minoli, Principal Deputy General Counsel
Office of General Counsel
Jane Nishida, Principal Deputy Assistant Administrator
Office of International and Tribal Affairs
Dennis McLerran, Regional Administrator
Region 10
TO:	Carolyn Copper, Assistant Inspector General
Office of Program Evaluation
Thank you for the opportunity to respond to the issues and recommendations in the draft subject
audit report. Following is a summary of the Environmental Protection Agency's (EPA or
Agency) overall position, along with its position on each of the report recommendations. The
Agency agrees to implement the three recommendations provided by the Office of Inspector
General. We are providing our response to those recommendations and estimated completion
dates. For your consideration, we are also including technical comments in the attachment to
supplement this response. The EPA is providing this coordinated response on behalf of Region
10, the Office of International and Tribal Affairs, the Office of General Counsel, the Office of
Water, and the Office of Research and Development.
The EPA recognizes the OIG staffs diligence in conducting this evaluation and learning about
the history of the Agency's development of the Bristol Bay Watershed Assessment. The EPA
appreciates the OIG's comprehensive evaluation, including the review of an extensive volume of
information provided by the EPA and other parties. The EPA worked thoroughly to provide the
full spectrum of information sought by the OIG including guidance documents, policies, and
procedures, briefing materials, access to EPA employees and officials, access to email databases
and calendars, external correspondence, meeting participant lists, and the EPA responses to
Congressional document requests.
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AGENCY'S OVERALL POSITION
The EPA acknowledges the OIG's findings that in conducting the Bristol Bay Watershed
Assessment, the EPA successfully followed ecological risk assessment, peer review, and
Information Quality Act policies and procedures. We are pleased that the OIG found no evidence
of bias by the EPA in its development of the Bristol Bay Watershed Assessment. The OIG's
findings are consistent with the EPA's intent to conduct a public process that accounted for all
perspectives and engaged all interested stakeholders to ensure that the resulting document was a
valuable scientific resource. In addition to creating and maintaining an open and transparent
process, the EPA also sought to guarantee that the assessment incorporated high quality data and
that all findings were scientifically sound by conducting an independent, external peer review
process. We appreciate your coordination with Region 10, the Office of International and Tribal
Affairs, the Office of General Counsel, the Office of Water, and the Office of Research and
Development.
AGENCY'S RESPONSE TO REPORT RECOMMENDATIONS
The EPA has reviewed the recommendations of the OIG and we concur with all
recommendations. We are providing our response to those recommendations and estimated
completion dates.
Agreements
No.
Recommendation
High-Level Intended Corrective
Action(s)
Estimated
Completion
Date
1
Incorporate in the EPA's
ethics training examples of
misuse of position in
interactions with
stakeholders related to the
OIG's findings in this
report.
The Office of General Counsel/Ethics
will address misuse of position in
upcoming ethics training. In
particular, the training will include at
least one example of collaboration
with stakeholders and the ethical role
of employees.
For the 2016
annual ethics
training, to be
launched in
October 2016.
2
Work with the EPA's
Designated Agency Ethics
Official (the Principal
Deputy General Counsel) to
define appropriate and
ethical parameters of tribal
assistance and include that
in EPA's mandatory tribal
training.
Coordinate with OGC/Ethics for them
to write at least one slide to be
included in mandatory tribal training
that explains the ethical obligations of
EPA employees when working with
stakeholders.
For the next
"Working
Effectively with
Tribal
Governments"
Training.
3
Issue a memo to Region 10
staff emphasizing the
importance of adhering to
the Standards of Ethical
Conduct for Employees of
the Executive Branch,
The Regional Administrator will issue
a memo to Region 10 staff
emphasizing the importance of ethical
integrity in carrying out regional
activities, and in adhering to the
Standards of Ethical Conduct for
January 2016
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particularly when dealing
with external parties with
an interest in requesting or
petitioning the EPA to take
regulatory or administrative
action.
Employees of the Executive Branch,
particularly when dealing with
external parties with an interest in
requesting or petitioning the EPA to
take regulatory or administrative
action.

CONTACT INFORMATION
If you have any questions regarding this response, please contact David Allnutt, Director, Office
of Ecosystems, Tribal and Public Affairs, EPA Region 10 at (206) 553-2581.
Attachment
cc: Lek Kadeli
Principal Deputy Assistant Administrator for Management, Office of Research and
Development
Joel Beauvais
Acting Deputy Assistant Administrator, Office of Water
Avi Garbow
General Counsel, Office of General Counsel
Justina Fugh
Senior Counsel for Ethics, Office of General Counsel
Kim Farnham
Audit Follow-up Coordinator, Region 10
Ryan S. Humrighouse
Audit Follow-up Coordinator, Office of International & Tribal Affairs
Charles Starrs
Audit Follow-up Coordinator, Office of General Counsel
Heather Cur si o
Audit Follow-up Coordinator, Office of Research and Development
Marilyn Ramos
Audit Follow-up Coordinator, Office of Water
Nic Grzegozewski
Agency Audit Follow-up Coordinator
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Appendix D
Distribution
Office of the Administrator
General Counsel
Principal Deputy General Counsel
Principal Deputy Assistant Administrator for International and Tribal Affairs
Regional Administrator, Region 10
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Principal Deputy Assistant Administrator for Management, Office of Research and Development
Deputy Assistant Administrator, Office of Water
Senior Counsel for Ethics, Office of General Counsel
Audit Follow-Up Coordinator, Office of General Counsel
Audit Follow-Up Coordinator, Office of International and Tribal Affairs
Audit Follow-Up Coordinator, Office of Research and Development
Audit Follow-Up Coordinator, Office of Water
Audit Follow-Up Coordinator, Region 10
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