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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Operating efficiently and effectively
EPA Does Not Always
Adhere to Its Established
Action Development
Process for Rulemaking
Report No. 21-P-0115
March 31, 2021
Average Adherence to
EPA's Rulemaking
Process
Average Nonadherence
to EPA's Rulemaking
Process
Average Undetermined
Adherence to EPA's
Rulemaking Process
-------
Report Contributors: Patrick Gilbride
Erin Barnes-Weaver
Alicia Buchanan
Allison Krenzien
Fred Light
Lumi Mema
Abbreviations
ADP
Action Development Process
ANPRM
Advance Notice of Proposed Rulemaking
C.F.R.
Code of Federal Regulations
CERCLA
Comprehensive Environmental Response, Compensation, and Liability Act
EPA
U.S. Environmental Protection Agency
GAO
U.S. Government Accountability Office
GHG
Greenhouse Gas
NESHAP
National Emission Standards for Hazardous Air Pollutants
NPRM
Notice of Proposed Rulemaking
OAR
Office of Air and Radiation
OCSPP
Office of Chemical Safety and Pollution Prevention
OIG
Office of Inspector General
OLEM
Office of Land and Emergency Management
OMB
Office of Management and Budget
OP
Office of Policy
ORPM
Office of Regulatory Policy and Management
OW
Office of Water
RSC
Regulatory Steering Committee
RTR
Risk and Technology Review
TSCA
Toxic Substances Control Act
U.S.C.
United States Code
Cover Image: Graphic depiction of color-coding used in the report to demonstrate the results
of our analysis—variation in the EPA's adherence to its Action Development
Process checklist steps ranged from 44 to 100 percent. (EPA OIG graphic)
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At a Glance
Why We Did This Audit
We conducted this audit to
determine whether the
U.S. Environmental Protection
Agency adhered to its Action
Development Process for
selected rulemakings.
The EPA designed the ADP
over 30 years ago to equip rule
writers with the tools necessary
to write regulations. We
developed a checklist to assess
58 Tier 1 and 2 rules with
tiering dates from fiscal
years 2015 through 2019 for
ADP adherence. Tier 1 and 2
rules include four major
milestones per the EPA's
Action Development Process:
Guidance for EPA Staff on
Developing Quality Actions. For
each rule, we reviewed
available information in the
EPA's ADP Tracker system
and requested and reviewed
needed documentation from
the EPA's Office of Policy and
rule leads in program offices.
This audit addresses the
following:
• Operating efficiently and
effectively.
This audit addresses this top
EPA management challenge:
• Complying with key internal
control requirements (data
quality; policies and
procedures).
Address inquiries to our public
affairs office at (202) 566-2391 or
OIG WEBCOMMENTS@epa.gov.
List of OIG reports.
EPA Does Not Always Adhere to Its Established
Action Development Process for Rulemaking
What We Found
Based on analysis of the progression of 58 selected rules
through the rulemaking process, we found wide variation
in the EPA's adherence to its ADP, ranging from 44 to
100 percent. Using a checklist to assess adherence, we
found approximately 81 percent adherence, 14 percent
nonadherence, and 6 percent undetermined adherence
to steps in the rulemaking process.
ADP goals are to
deliver actions that
are based on sound
science, promote
economic
efficiency, and are
implementable and
enforceable.
We found variation in ADP adherence by program office, economic significance
of the rulemaking, and major milestone. For example, adherence for
economically significant rules was 5 percent less than overall adherence to the
checklist. Additionally, average adherence for major ADP milestones was less
than overall adherence to the checklist. We identified two reasons for
nonadherence in the rules evaluated:
• The Office of Policy allowing milestones to be skipped by designating them
as "moot," a term or practice not addressed in the ADP Guidance.
• The Office of Policy and program offices not maintaining documentation on
major milestones in ADP Tracker. We found that 30 of 58 rulemakings
contained less than half of major milestone documentation in the system.
Interviewees and notes in ADP Tracker indicated that reasons for designating
milestones as moot included expediting rulemaking timelines and considering
milestones as unnecessary for specific rulemakings. Missing documentation
stemmed from inconsistent program office approaches to data entry, confusion
on some items, and a lack of system monitoring by the Office of Policy for data
quality. Interviewees said ADP training could be improved, and we found that
resource constraints, staff unavailability, and competing demands have not
allowed time to conduct formal, in-person training for several years. Key Agency
stakeholders said that the ADP should be followed and that the ADP results in
consistently high-quality rules when implemented appropriately.
Recommendations and Planned Agency Corrective Actions
We recommend that the Office of Policy annually reinforce the administrator's
expectation on following the ADP, including waiver procedures for Tier 1 and 2
actions. We also recommend that the office query rulemaking stakeholders on
the use of the moot designation and, if necessary, define and clarify its
applicability and expected documentation. Additionally, we recommend that the
office define key regulatory decisions and information, to include in the tracking
database, and coordinate with program offices on periodic system checks.
Finally, we recommend querying EPA staff on the adequacy of training. One
recommendation is resolved with corrective actions pending, and four
recommendations are unresolved with resolution efforts in progress.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
March 31, 2021
MEMORANDUM
SUBJECT: EPA Does Not Always Adhere to Its Established Action Development Process for
Rulemaking
Report No. 21-P-0115
This is our report on the subject audit conducted by the Office of Inspector General of the
U.S. Environmental Protection Agency. The project number for this audit was QA&E-FY20-0067. This
report contains findings that describe the problems the OIG has identified and corrective actions the OIG
recommends. Final determinations on matters in this report will be made by EPA managers in accordance
with established audit resolution procedures.
The Office of Policy is responsible for the issues discussed in this report.
In accordance with EPA Manual 2750, your office provided acceptable planned corrective actions and
estimated milestone dates for Recommendation 3. This recommendation is resolved with corrective action
pending.
Action Required
Recommendations 1, 2, 4, and 5 are unresolved. The resolution process, as described in the EPA's Audit
Management Procedures, begins immediately with the issuance of this report. Furthermore, we request a
written response to the final report within 60 days of this memorandum. Your response will be posted on
the OIG's website, along with our memorandum commenting on your response. Your response should be
provided as an Adobe PDF file that complies with the accessibility requirements of Section 508 of the
Rehabilitation Act of 1973, as amended. The final response should not contain data that you do not want
to be released to the public; if your response contains such data, you should identify the data for redaction
or removal along with corresponding justification.
FROM:
TO:
Victoria Arroyo, Associate Administrator for Policy
Office of the Administrator
We will post this report to our website as www.epa.gov/oig.
-------
EPA Does Not Always Adhere to Its Established Action
Development Process for Rulemaking
21-P-0115
Table of C
Chapters
1 Introduction 1
Purpose 1
Background 1
Responsible Office 6
Promising Practices 6
Scope and Methodology 6
2 ADP Adherence Varied and Was Lower for Major Milestones
and Economically Significant Rules 8
Details on OIG's Checklist and Adherence to Checklist Items 11
ADP Adherence Varied by Office, Rule Significance, and
Major Milestone 13
3 Several Factors Contribute to ADP Nonadherence 16
Waivers Used for Tier 1 Rules Despite Clear Administrator Direction 16
Undefined Moot Designations Resulted in Lower Adherence 17
Lack of Documentation in ADP Tracker Hindered Adherence
Determinations 19
ADP Training Should Be Improved 25
Conclusion 26
Recommendations 27
Agency Response and OIG Assessment 27
Status of Recommendations and Potential Monetary Benefits 29
Appendices
A Internal Control Assessment 30
B Detailed Scope and Methodology 31
C OIG Checklist Used to Assess ADP Adherence 35
D Adherence of Selected Rulemakings 37
E Agency Response to Draft Report 44
F Distribution 49
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Chapter 1
Introduction
Purpose
The U.S. Environmental
Protection Agency Office of
Inspector General conducted
this audit to determine
whether the EPA adhered to
its Action Development
Process for selected
rulemakings.
Background
EPA's Regulatory Development
The EPA is one of the most active
Developing environmental regulations
is one of the Agency's principal tasks,
and much of the EPA's environmental
success and organizational credibility is
directly linked to the quality of this
work. Therefore, it is important for the
EPA's actions to be based on sound
scientific, economic, legal, and policy
analyses and for the Agency to involve
the public throughout development.
EPA Action Development Process:
Guidance for EPA Staff on Developing
Quality Actions (March 2018)
The EPA designed the ADP over 30 years ago to equip rule writers with the tools
necessary to write regulations. Per the EPA's Action Development Process:
Guidance for EPA Staff on Developing Quality Actions (dated March 2018), also
known as the ADP Guidance, the ADP is designed to bring together a diverse
group of professionals throughout the Agency to work collaboratively to develop
and deliver "agency actions" that are based on sound science, promote economic
Top Management Challenge
This audit addresses the following top management
challenge for the Agency, as identified in OIG Report
No. 20-N-0231, EPA's FYs 2020-2021 Top Management
Challenges, issued July 21, 2020:
• Complying with key internal control requirements
(data quality; policies and procedures).
regulatory agencies in the federal
government, and writing regulations is one
of the most significant tools the EPA has to
protect human health and the environment.
An overarching goal in Working Together:
FY 2018-2022 U.S. EPA Strategic Plan is
to have more effective partnerships,
including increasing public platforms for
meaningful participation in regulatory
development. The plan includes strategies
for the EPA "to reinvigorate its approach to
regulatory development," prioritize meeting
statutory deadlines, and ensure that Agency
actions are defensible and consistent with
its authorities.
EPA's Action Development Process
21-P-0115
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efficiency, and are implementable and enforceable. The ADP Guidance uses the
term "agency actions" to refer to a variety of actions, including proposed rules
and final rules signed by the EPA administrator. The Administrative Procedure
Act, specifically 5 U.S.C. § 551(4), defines "rule" to mean "the whole or a part of
an agency statement of general or particular applicability and future effect
designed to implement, interpret, or prescribe law or policy." For purposes of this
report, we refer to Agency actions involving proposed or final rules as "regulatory
actions."
The ADP serves as a comprehensive framework to ensure the use of quality
information to support EPA actions and an open process for action development.
It also provides opportunities for early senior management involvement and
provides guidance and direction to staff at key points in the process. Per the ADP
Guidance, the ADP also relies on collaborative involvement at the staff level
across the Agency to ensure that actions are discussed and developed using all the
available and appropriate Agency expertise. As such, the ADP encourages using a
staff workgroup to share information and draft rulemaking materials. Table 1
describes the five major stages of the EPA's ADP Guidance.
Table 1: Five major ADP stages
1
Tiering the Action. Agency actions developed through the ADP are assigned to
one of four tiers based on the ADP Guidance criteria. Tier 1 and 2 actions may
require extensive cross-agency involvement, new science, or nonroutine
application of existing science or have the potential for precedent-setting
implementation issues, policy implications, or economic considerations. The tier
determines the complexity of the process that the workgroup will use to develop
the action. During development of an action, the lead office may adjust the tiering
designation with justification and approval.
Actions include proposed rules, also called a notice of proposed rulemaking, and final rules.
If used, an advance notice of proposed rulemaking also follows the ADP at the appropriate
tier level.
2
Developing the Proposed Rule/Draft Action. Once the action has been tiered,
the lead program office and the convened workgroup begins developing the action.
3
Requesting Office of Management and Budget Review (if necessary). Actions
deemed significant generally require OMB review under Executive Order 12866,
Regulatory Planning and Review. This stage involves preparing the action for OMB
review and addressing input received as a result of the OMB's review. Executive
Order 12866 lists four factors that define a "significant regulatory action," one of
which includes economic significance.
A regulatory action is "economically significant" if the OMB determines that the action is
likely to have an annual effect on the economy of $100 million or more or adversely affect—
in a material way—the economy; a sector of the economy; productivity; competition; jobs;
the environment; public health or safety; or state, local, or tribal governments or
communities. For all "economically significant" regulations, Executive Order 12866 directs
agencies to provide a more detailed assessment of the anticipated benefits and costs of the
action, as well as an assessment of the benefits and costs of potentially effective and
reasonably feasible alternatives.
4
Signing and Publishing an Action in the Federal Register and Soliciting and
Accepting Public Comments. This stage includes requesting a signature of the
21-P-0115
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appropriate EPA official on proposed and final actions, publishing actions, and
soliciting and accepting public comments for proposed rules.
Developing the Final Action. The workgroup reconvenes to finalize the action.
This stage also includes efforts to comply with the Congressional Review Act.
Source: OIG summary of the ADP Guidance. (EPA OIG table)
Stages 2 and 5, on proposed and final rules, include four major milestones or key
documents that the ADP Guidance describes as typically required for Tier 1 or
Tier 2 actions. Table 2 shows the relationship between tiering and the
development process for the four major milestones called for under the ADP.
Table 2: ADP requirements for four major milestones by tier
Tier 1
Tier 2
Tier 3
Early Guidance
Initial guidance from senior management,
including policy priorities and expectations
of the workgroup.
Must be
addressed
Must be
addressed
Optional
Analytic Blueprint
A workgroup's plan for conducting analyses
to support action development.
Must be
addressed*
Must be
addressed*
Optional
Options Selection
The workgroup identifies significant issues
and a range of options to resolve each
issue. Senior management then selects the
options that would best achieve the goals of
the action.
Must be
addressed
Must be
addressed
Optional
Final Agency Review
The last point for internal EPA review of an
action. For Tier 1 and 2 actions, final
Agency review meetings are held to confirm
that all issues have been resolved or
elevated for resolution; the action package
is ready for OMB, if required, or signature;
and all EPA and external requirements have
been met.
Must be
addressed
Must be
addressed
Optional
(workgroup
closure)
Source: ADP Guidance. (EPA OIG table)
*Updated as needed by the workgroup after proposed rule stage.
Though presented as a step-by-step guide, the ADP is not intended to be a rigid
process, as the ADP Guidance notes that "[flexibility is often appropriate during
the application of the ADP when developing a quality action." It indicates that the
workgroup and senior management should work out details of the process for
each action. When needed and appropriate, the workgroup may collectively adjust
the process for actions to address timing and sequencing concerns with the
addition or deletion of milestones. Individual milestones may be waived if the
workgroup agrees that the milestone in question is not needed or that an expedited
action development cycle is required to meet critical, time-sensitive
commitments, such as court deadlines or the administrator's target dates. The
ADP Guidance describes the process to waive a milestone.
21-P-0115
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While approved waivers allow for flexibility in the process, the ADP Guidance
notes that regulatory actions that meet Tier 1 or Tier 2 criteria should be
developed through the Agency's ADP. Additionally, on August 22, 2018,
then-Administrator Andrew Wheeler issued a memorandum to all assistant and
regional administrators to "reinforce compliance with the ADP to the maximum
extent possible as we develop agency actions."
Then-Administrator Wheeler also added:
Particularly for Tier 1 and 2 actions, I expect that the ADP process
will be followed and that all major ADP milestones will be met. I
do not intend to waive ADP milestones for Tier 1 rules, which are
defined under the ADP as those actions reflecting the
Administrator's top priorities and requiring extensive cross-office
coordination. As a reminder, requests to waive Tier 1 or Tier 2
milestones generally require the approval of the Associate
Administrator for the Office of Policy.
Additionally, the EPA's Scientific Integrity Policy "requires adherence to Agency
documents that address the use and characterization of scientific information in
Agency policy development, such as EPA's Action Development Process."
Offices Involved in the ADP
As noted above, the ADP is a collaborative process that encourages using a staff
workgroup to share information and draft rulemaking documents. As part of the
tiering process, the lead office formally charters a workgroup and other interested
program offices, including the EPA's Office of Children's Health Protection and
regional offices, assign representatives. Additionally, according to the ADP
Guidance, the following "core" EPA offices should be invited to participate in
workgroups for all Tier 1 and Tier 2 actions:
• Office of Policy.
• Office of General Counsel.
• Office of Enforcement and Compliance Assurance.
• Office of Research and Development.
The workgroup chair and members work together to develop an action and
represent their office's or region's management positions on issues. The ADP
Guidance lists several workgroup responsibilities, including ensuring that the
documentation of issues raised within the members' individual offices and the
views of all workgroup members are heard and considered during workgroup
deliberations.
The OP's associate administrator oversees the regulatory process. The OP and its
staff within the Office of Regulatory Policy and Management manage the
21-P-0115
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regulatory development process for the Agency, as well as the day-to-day
operations and information systems that underpin the process. The ORPM helps
to ensure that the EPA uses the most appropriate analytic information to
determine regulatory policy; serves as the liaison to other federal agencies for all
actions; and manages the ADP and its infrastructure, such as the tracking systems
described below. The ORPM works with program offices as early as possible in
the ADP. Additionally, in the context of typical workgroup activities, two OP
divisions are particularly active:
• Policy and Regulatory Analysis Division. This division assigns a
workgroup member who participates in nearly all tiered actions; serves as
the OP's primary point of contact; and provides policy analysis, advice,
and a cross-media perspective.
• Regulatory Management Division. This division assigns a desk officer to
each program office to serve as the point of contact for management and
procedural aspects of ADP-related activities, such as transmitting
documents to the OMB for interagency review.
Additionally, the ADP includes a Regulatory Steering Committee to integrate and
carry out the operational details of the ADP. The RSC is a standing body with
representation from each program office and region; the general counsel; and
cross-media offices, such as the Office of Children's Health Protection.
ADP Resources, Tracking, Reporting, and Record Keeping
The OP maintains resources on its online ADP Library to assist with the process,
which includes links to guidance, templates, executive orders, and self-paced
training materials and webinars. The ADP Library also contains links to
information about the ADP Tracker system. The EPA developed ADP Tracker in
2012, which replaced a previous database, to better help the Agency manage and
track actions, milestones, workgroups, and workflow. A 2013 memorandum from
the RSC chair to all RSC members states that documentation associated with the
four major ADP milestones listed in Table 2 must be uploaded into ADP Tracker.
The ORPM manages ADP Tracker. Since the EPA is moving away from Lotus
Notes-based systems, such as ADP Tracker, the OP plans to launch a
replacement, called the EPA Action Management System, in the summer of 2021.
The OP has been developing the replacement system since 2016.
Every fall and spring, federal agencies, including the EPA, combine efforts to
publish a comprehensive report describing regulations under development or
recently completed. These reports are bundled and published as the Unified
Agenda of Federal Regulatory and Deregulatory Actions. Each agency' s
contribution is called a semiannual regulatory agenda. Once a year, each agency
releases a regulatory plan as a subset of the fall regulatory agenda in accordance
with Executive Order 12866. Agencies' regulatory plans describe the most
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important regulations that the agencies reasonably expect to propose or finalize
during the upcoming fiscal year, and the EPA's website notes that "these are the
regulatory actions that embody the core of our regulatory priorities."
ADP Tracker houses key decisions and information on the Agency's rulemakings.
The Federal Records Act requires agencies to make and preserve records
containing adequate and proper documentation of the agencies' decisions.1
Guidelines from the National Archives and Records Administration define
trustworthy records as being reliable, authentic, integral, and usable. Additionally,
Section 6.2 of the EPA's Interim Records Management Policy requires the
Agency to document the formulation and execution of basic policies and
decisions.
An official record-keeping system is
an "information management system
which captures, manages and
provides access to records through
time" and can be electronic or paper-
based, until an appropriate electronic
record-keeping system becomes
available.
EPA Interim Records Management
Policy (August 2018)
The OP is responsible for the issues
discussed in this report.
Promising Practices
Desk officers within the OP's Regulatory Management Division noted that their
director, after assuming the role in April 2019, developed useful work aids, such
as written procedures with screenshots and directions for database tracking.
Interviewees also lauded the RSC for providing valuable cross-agency input and
information on rulemakings and the Regulatory Management Division's director
for working through the RSC to further improve the ADP.
Scope and Methodology
We conducted this performance audit from January 2020 through February 2021
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 audit objective. We believe that the evidence obtained
provides a reasonable basis for our findings and conclusions.
1 44 U.S.C. § 3101.
The EPA's Records Center confirmed that
the ADP Tracker and the anticipated EPA
Action Management System are registered
information systems and are not designated
as official record-keeping systems.
According to the OP, the EPA uses other
enterprise record-keeping tools to preserve
official records.
Responsible Office
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As detailed in Appendix A, we assessed the internal controls necessary to satisfy
our audit objective.2 In particular, we assessed the internal control components
and underlying principles—as outlined in the GAO's Green Book—significant to
our audit objective. Any internal control deficiencies we found are discussed in
this report.
To address our objective, we reviewed relevant statutes, executive orders, and
OMB materials on regulatory actions. We reviewed the EPA's 2015 and 2018
ADP Guidance and related materials, memorandums, trainings, and websites. We
also reviewed materials on the Agency's ADP Tracker system and the EPA
Action Management System. To understand different ADP roles and
responsibilities, we interviewed OP managers and staff and RSC members. We
also interviewed staff in the Office of Research and Development and the Office
of Enforcement and Compliance Assurance as these are two of the four core
offices designated by the ADP Guidance to participate in all Tier 1 and Tier 2
workgroups. We also interviewed staff in the Office of Children's Health
Protection and the Office of Congressional and Intergovernmental Relations, as
well as the EPA's scientific integrity official.
We used the Agency's ADP Guidance to develop a 15-step checklist to assess
58 rules for ADP adherence. We selected Tier 1 or 2 rulemakings from fiscal
years 2015 through 2019. For each rulemaking, we reviewed available
information in ADP Tracker and requested and reviewed documentation from the
OP and rule workgroup chairs or program office points of contact. As needed, we
interviewed OP analysts and workgroup chairs or points of contact to ask rule-
specific questions to verify information on activities and decisions. We did not
perform analysis to determine the statistical significance of any differences we
observed.
Appendix B provides additional details on our scope and methodology.
Appendix C contains the checklist we developed to assess ADP adherence.
2 An entity designs, implements, and operates internal controls to achieve its objectives related to operations,
reporting, and compliance. The U.S. Government Accountability Office sets internal control standards for federal
entities in GAO-14-704G, Standards for Internal Control in the Federal Government (also known as the "Green
Book"), issued September 10, 2014.
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Chapter 2
ADP Adherence Varied and Was Lower for Major
Milestones and Economically Significant Rules
We analyzed 58 of the rulemakings designated as Tier 1 or Tier 2 from fiscal
years 2015 through 2019 using the 15-step checklist we developed using the ADP
Guidance. We assessed ADP adherence for each rule based on the rule's
progression through the rulemaking process from the time the rule was tiered until
January 22, 2020, when we first met with the Agency about this evaluation. For
simplicity, we assigned each checklist step equal weight in our analysis. We
found wide variation with each individual rule's ADP adherence, ranging from
44 to 100 percent. We determined approximately 81 percent average adherence to
checklist steps and 14 percent average nonadherence to checklist steps in the
rulemaking process.3 Average ADP adherence was unable to be determined for
6 percent of checklist steps in the rulemaking process because of a lack of
sufficient documentation. Ten rules were 100 percent adherent to our checklist
steps. These average adherence values should not be extrapolated to the broader
group of all EPA rulemakings.
The number of applicable checklist questions for each rule varied based on the
rule's progression through the Advance Notice of Proposed Rulemaking, Notice
of Proposed Rulemaking, and final rulemaking phases of the rulemaking process.
Out of the 58 rules we reviewed, five had an ANPRM phase, 55 had an NPRM
phase, and 27 had a final phase. Most rules we evaluated had only an NPRM
phase or an NPRM phase and a final phase. Figure 1 shows which phases the
rules we reviewed completed.
Figure 1: Frequency of applicable phases in 58 selected rulemakings
Source: OIG analysis. (EPA OIG graphic)
1 Totals throughout do not always equal 100 percent because of rounding.
21-P-0115
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Tables 3 and 4 show those rules with the highest and lowest adherence, ranging
from 44 to 100 percent. Appendix D lists the range of checklist step adherence
rates for all 58 rules. Because some rules were under development during our
audit, information, such as Executive Order 12866 significance or tiering level,
may have changed since we initiated our review. Our analysis includes 17 of the
48 EPA actions in the Fact Sheet: List of Agency Actions for Review under
Executive Order 13990: Protecting Public Health and the Environment and
Restoring Science to Tackle the Climate Crisis 4 Five of the 17 rules included in
this list are among the ten rules in our sample that were least adherent to the ADP,
as noted in Table 4.
Table 3: Rules most adherent to the ADP
Rule title
Program
office
OMB
significance
Yes
ADP adherence*
No Undetermined
Financial Responsibility
Requirements under
Comprehensive
Environmental Response,
Compensation, and Liability
Act Section 108(b) for the
Petroleum and Coal
Office of
Land and
Emergency
Management
Significant
100%
0%
0%
Products Manufacturing
Industry
Financial Responsibility
Requirements under
CERCLA Section 108(b) for
OLEM
Significant
100%
0%
0%
the Chemical Manufacturing
Industry
Office of
Review of Dust-Lead Post-
Chemical
Abatement Clearance
Safety and
Significant
100%
0%
0%
Levels**
Pollution
Prevention
Oil and Natural Gas Sector:
Emission Standards for
Office of Air
Economically
Significant
New, Reconstructed, and
and
100%
0%
0%
Modified Sources
Radiation
Reconsideration**
Control of Air Pollution
From Aircraft and Aircraft
Engines: Proposed
Greenhouse Gas Emissions
OAR
Significant
100%
0%
0%
Standards and Test
Procedures**
Clean Energy Incentive
Program Design Details
OAR
Significant
100%
0%
0%
4 Executive Order 13990 (dated January 20, 2021) directs all executive agencies to review regulations and other
agency actions promulgated, issued, or adopted during the preceding four years and consider suspending, revising,
or rescinding any that conflict with objectives set forth in the executive order.
21-P-0115
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Rule title
Program
office
OMB
significance
Yes
ADP adherence*
No Undetermined
National Emission
Standards for Hazardous
Air Pollutants: Generic
Maximum Achievable
Control Technology
OAR
Nonsignificant
100%
0%
0%
Standards Residual Risk
and Technology Review for
Ethylene Production
NESHAP: Integrated Iron
and Steel Manufacturing
Facilities RTR
OAR
Nonsignificant
100%
0%
0%
Endangerment Finding for
Lead Emissions from
OAR
N/A
100%
0%
0%
Piston-Engine Aircraft Using
Leaded Aviation Gasoline
Clean Water Act 404
Office of
Water
Assumption Update
Regulation
N/A
100%
0%
0%
Source: OIG analysis. (EPA OIG graphic)
* "Yes" includes percent of checklist items that adhered to the ADP (includes approved waivers); "no" includes
percent of checklist items that did not adhere to the ADP (includes moot steps, a term not included in the ADP
Guidance); and "undetermined" includes percent of checklist items for which ADP adherence was unable to be
determined.
** Included in the list of 48 rules to be reviewed under Executive Order 13990.
Table 4: Rules least adherent to the ADP
Rule title
Program
office
OMB
significance
ADP adherence*
Yes No Undetermined
Repeal of Carbon
Pollution Emission
Guidelines for Existing
Stationary Sources:
Electric Utility Generating
Units
OAR
Economically
Significant
67%
33%
0%
NESHAP: Coal- and Oil-
Fired Electric Utility
Steam Generating
Units—Reconsideration
of Supplemental Cost
Finding and RTR**
OAR
Significant
65%
24%
12%
Addition of Certain Per-
and Polyfluoroalkyl
Substances to the Toxics
Release Inventory
OCSPP
Significant
64%
18%
18%
Renewable Fuel
Standard Program:
Standards for 2020,
Biomass-Based Diesel
Volumes for 2021, and
Other Changes
OAR
Significant
63%
0%
37%
Fuels Regulatory
Streamlining
OAR
N/A
63%
13%
25%
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Rule title
Program
office
OMB
ADP adherence*
Yes No Undetermined
Definition of "Waters of
the United States" -
Recodification of
Preexisting Rule
OW
Economically
Significant
57%
24%
19%
Strengthening
Transparency in
Regulatory Science**
Office of
Research
and
Development
Significant
50%
33%
17%
Modernizing the
Administrative
Exhaustion
Requirements for
Permitting Decisions and
Streamlining Procedures
for Permit Appeals**
Office of
General
Counsel
Nonsignificant
45%
27%
27%
The Navigable Waters
Protection Rule:
Definition of "Waters of
the United States"**
OW
Significant
44%
31%
25%
The Safer Affordable
Fuel-Efficient Vehicles
Rule for Model Years
2021-2026 Passenger
Cars and Light Trucks**
OAR
Economically
Significant
44%
56%
0%
Source: OIG analysis. (EPA OIG graphic)
* "Yes" includes percent of checklist items that adhered to the ADP (includes approved waivers); "no" includes
percent of checklist items that did not adhere to the ADP (includes moot steps, a term not included in the ADP
Guidance); and "undetermined" includes percent of checklist items for which ADP adherence was unable to be
determined.
** Included in the list of 48 rules to be reviewed under Executive Order 13990.
We describe below additional details on our analysis of 58 selected rulemakings
and adherence rates by program office, economic significance, and major
milestone.
Details on OIG's Checklist and Adherence to Checklist Items
As shown in Figure 2, we defined adherence when we answered applicable
checklist items with yes, an approved waiver was provided, or a date in ADP
Tracker was verified by documentation.5 We defined nonadherence when at least
one item was answered with no or "moot," a term not included or defined in the
EPA's ADP Guidance. Chapter 3 of this report notes additional findings on
"moot" designations. We also included an undetermined adherence classification
in which at least one item lacked sufficient documentation to determine adherence
against the checklist. After several attempts to obtain documentation explicitly
confirming adherence from the EPA, we concluded that there was not sufficient
evidence to determine adherence for some checklist steps. Reasons for
5 We could not obtain tiering forms because of mandatory telework during the coronavirus pandemic.
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undetermined adherence include incomplete ADP Tracker information and
inaccessible digital records because of employees changing positions or leaving
the Agency.
Figure 2: Determining ADP adherence
> Developed checklist based on ADP Guidance documents.
> Evaluated 58 rulemakings designated as Tier 1 or 2 from fiscal years 2015 through
2019 at various phases in the rulemaking process (ANPRWI, NPRM, final}.
> Determined ADP adherence for each rule based on the number of checklist
questions applicable to the rule.
•Completed checklist
step.
¦ADP step and date
verified in ADP
Tracker.
¦Milestone
designated "waived"
by the prescribed
procedure in the
ADP Guidance when
steps are deemed
unnecessary by the
workgroup.
¦ Incomplete
checklist step.
•ADP step was not
performed.
•Milestone
designated "moot."
Source: EPA OIG analysis. (EPA OIG graphic)
(
S)
>
0
u
c
•Completion of
checklist step
CD
could not be
determined.
<
¦a
¦ Documentation
<
of ADP step
-o
O)
tz
could not be
provided upon
"1
OIG request.
-------
Figure 3: Distribution of rule adherence
25
20
15
E -g 10
22
22
10
4-4-50% 51-80% 81-99% 100%
Percentage ADP adherence to checklist steps
Source: OIG analysis. (EPA OIG graphic)
ADP Adherence Varied by Office, Rule Significance, and Major
Milestone
ADP Adherence Varied by Program Office
Rules were developed by multiple program offices, and Figure 4 notes the number
of rules within each program office.
Figure 4: Rule adherence by program office
OAR (32) 5%
OCSPP(11) 5%
OLEM (5) 3°/
OW (7) 8%
AVERAGE 6% I
Undetermined ¦ Nonadherent ¦ Adherent
Source: OIG analysis. (EPA OIG graphic)
Note: The OP, the Office of General Counsel, and the Office of Research and Development each had
only one Tier 1 or 2 rule from fiscal years 2015 through 2019. These offices are excluded from Figure 4
because of infrequent rulemaking compared to other program offices. Average adherence is based on
an analysis of 58 rules progressing through various phases of rulemaking.
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Economically Significant Rules Had Lower ADP Adherence
The 58 selected rulemakings included 42 that were classified as significant under
Executive Order 12866 and eight that were not significant. The significance level
was not yet determined under Executive Order 12866 for eight of the 58 rules. Of
the 42 significant rules, ten were economically significant. The significance level
is an indicator of the impact of the rulemaking, as noted in Table 1. All ten
economically significant rules were Tier 1 in part because they had a large scope,
cost, level of impact, or level of public interest. One of the ten economically
significant rules was initially Tier 1 but was later reduced to Tier 2. Tier 1 rules
may have greater policy impacts and implications and may be supported by
precedent-setting applications of new science. We found that adherence was
75 percent for economically significant rules, 81 percent for significant rules, and
85 percent for nonsignificant rules. Nonadherence was 23 percent for
economically significant rules, 13 percent for significant rules, and 7 percent for
nonsignificant rules. Figure 5 illustrates how ADP adherence varied by
significance.
Figure 5: Rule adherence by Executive Order 12866 significance level
Economically Significant (10) 2'
23%
75%
Significant (32) i
Nonsignific ant (8)
13%
81%
8%
7%
85%
AVERAGE <
5%
14%
81%
Undetermined ¦Nonadherent "Adherent
Source: OIG analysis. (EPA OIG graphic)
Note: Executive Order 12866 significance levels had not been determined for eight of the
58 rules and are not included. Average adherence is based on an analysis of applicable
checklist steps for 58 rules progressing through various phases of rulemaking.
Adherence Lower for Major ADP Milestones
We found that adherence varied by the four major ADP milestones: early
guidance, analytic blueprint, options selection, and final agency review. As shown
in Table 5, average adherence for major milestones varied from 58 to 72 percent,
which was less than the overall ADP checklist adherence of 81 percent. Similarly,
average nonadherence varied from 20 to 36 percent, which was greater than
overall ADP checklist nonadherence of 14 percent.
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Table 5: Average rule adherence by major milestone3
Major Milestone
Adherent
Nonadherent
Undetermined
Early Guidance
59%
¦SM
5%
Analytic Blueprint
72%
7%
Options Selection
58%
30%
3%
Final Agency Review
59%
20%
21%
Source: OIG analysis. (EPA OIG table)
a Rules were evaluated based on their progression through the rulemaking process and
applicable major milestones.
One reason average milestone adherence may be lower than overall average ADP
adherence is that our checklist included steps that the EPA must complete, such as
sending a rule to the GAO or Congress before implementation. In contrast, the
four major ADP milestones are solely governed by the ADP Guidance and are
more flexible.
Additionally, interviewees indicated that early administrator involvement outside
of the formal milestone meetings may contribute to lower-than-average milestone
adherence. For example, a clear action plan and accelerated schedule may make
early guidance or options selection meetings redundant. According to the OP,
final agency review adherence may be lower because positions provided verbally
during these meetings are not always documented. While final agency review is
the opportunity for all internal rulemaking stakeholders to comment on the rule
before signature and publication, we observed a lack of written positions
documenting assistant or regional administrator concurrence or nonconcurrence of
the participating office or region for some of these milestone meetings.
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Chapter 3
Several Factors Contribute to ADP Nonadherence
Writing and implementing regulations are significant tools that the EPA uses to
protect human health and the environment. The EPA designed the ADP to equip
rule writers with the tools necessary to write rules through an open process that
consistently yields high-quality actions. OIG-assessed ADP adherence ranged
from 44 to 100 percent. We also noted lower adherence to the process for
economically significant rules and major ADP milestones. We identified two
reasons for nonadherence for the rules we evaluated:
• Program offices skipping milestones, without workgroup concurrence,
and, as a result, the OP designating milestones as "moot." We noted
inconsistent documentation for moot justifications.
• The OP and program offices not maintaining documentation on major
milestones in ADP Tracker. We found that 30 of 58 rulemakings
contained less than half of major milestone documentation in the system.
Interviewees and notes in ADP Tracker indicated that reasons for designating
milestones as moot include expediting rulemaking timelines and considering the
milestone as unnecessary for specific rulemakings. Missing documentation in
ADP Tracker stemmed from inconsistent program office approaches to data entry,
confusion on some items, and a lack of system monitoring by the OP for data
quality. Additionally, several interviewees said ADP training could be improved.
Given the OP's resource constraints, staff unavailability, and competing demands,
as well as requests for shorter, on-demand training, the OP has not conducted
formal, in-person training for several years.
Key Agency stakeholders, such as rule workgroup chairs and OP analysts,
expressed confusion about the decision-making process in selected rules. In
response to our questions on risks to rule quality absent clear direction and
communication, all OP analysts and others interviewed indicated that the ADP
should be followed. They also shared that rules are consistently high quality when
the ADP is implemented appropriately and when the Agency's leadership treats
the ADP as necessary and important for quality actions.
Waivers Used for Tier 1 Rules Despite Clear Administrator Direction
When reviewing rules and available documentation in ADP Tracker, we included
waivers in our calculations for adherence as the ADP Guidance includes a formal
waiver process. The ADP allows adjusting the process depending on changing
circumstances. According to the ADP Guidance, those adjustments should be
documented in waivers approved by senior management in cases in which the
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workgroup deems that a step is unnecessary. Of the 58 rules analyzed, we noted
that the OP associate administrator approved waivers for 20 rules. Additionally,
we found no evidence of a requested waiver being disapproved. According to the
ORPM director, milestone waivers are nearly always granted by the OP associate
administrator, and participating offices typically agree to the waiver.
While thqADP Guidance allows for using waivers, then-Administrator Wheeler,
in an August 2018 memorandum, said, "I do not intend to waive ADP milestones
for Tier 1 rules, which are defined under the ADP as those actions reflecting the
Administrator's top priorities and requiring extensive cross-office coordination."
The memorandum reiterates the ADP requirements for requesting waivers,
suggesting that the administrator's memorandum only spoke to intent and did not
prohibit waivers. Even so, of the 20 rules with waivers, seven were Tier 1 rules at
some point during the review period, and six of those had at least one waiver
approved by the OP after the date of the administrator's memorandum. Notably,
of these six waivers, four pertained to milestones that were marked as
"completed" and not "waived" in ADP Tracker. During our review, we
considered all waivers granted at any point during our scope as adherent if the
waivers were requested in accordance with ADP Guidance.
Undefined Moot Designations Resulted in Lower Adherence
Moot designations contributed to lower OIG-assessed adherence rates, including
for economically significant rules. We found that 14 of 58 rules had milestones
designated as moot. It is unclear who is responsible for approving moot
designations, though OP desk officers ultimately enter designations, and
13 individual entries for five different rules in ADP Tracker indicated that
OP management directed the moot designations. Seven interviewees expressed
confusion on the meaning and usage of moot designations, including conflating
moot designations with the waiver process, and said the term should not exist in
the ADP.
ADP Guidance Does Not Define Moot, Resulting in Confusion on
Justifications for Its Use
The ADP Guidance does not define or discuss moot designations. We, therefore,
included milestones designated as moot in our calculations for nonadherence
because the step was not completed, and the waiver process was not followed.
Nonadherence because of moot designations occurred in 14 of 58 rules.
The ORPM director said that moot designations occur when circumstances have
evolved; for example, if a milestone is overtaken by events, such as an
unexpected schedule change, or a policy directive from a political appointee had
accomplished the intent of a particular ADP milestone. In such circumstances, the
OP determines whether it would be useful to complete a milestone because
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previous events made the milestone "moot." OP managers said they use the term
in the ADP Tracker system when running reports on upcoming milestones.
Interviewees provided various reasons for using the moot designation, some of
which we found overlapped with parameters for seeking waivers, indicating staff
confusion on the moot designation. We noted the following circumstances in
evaluating ADP Tracker and documents provided by program office staff, as well
as from interviews with workgroup chairs and points of contact for rules with
moot designations:6
• Retroactively designating a milestone as moot. For example, the
rulemaking was sent to the OMB for review before completing all major
milestones; later, the uncompleted milestones were designated as moot.
Eight rules noted this circumstance, and five of those listed OMB review
as the event precipitating the moot designation.
• Milestone waived at the NPRM phase and designated as moot for final
phase. One rule noted this circumstance.
• ADP Tracker stated that the OP designated the milestone as moot and no
further information was provided. Seven rules noted this circumstance.
• Compressed rulemaking schedule. Four rules noted this circumstance.
• Milestone not necessary for the type of rulemaking. For example, in
annual rulemakings with quick turnarounds involving frequent
conversations with leadership, formal milestones were not necessary. One
rule noted this circumstance.
Per the ADP Guidance, the formal waiver process could have been followed for at
least the last two circumstances, resulting in improved adherence to the process.
6 When rules had multiple moot justifications, we considered each independent justification when generating the
overall list.
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Use of Moot Designations Resulted in Lower Adherence, Particularly
for Economically Significant Rules
Of the 58 rules analyzed, 14 rules had
milestones designated as moot.
Additionally, 42 rules were OMB
significant, including ten economically
significant rules. Of those ten rules, six had
at least one moot designation and comprise
43 percent of all rules with moot
designations within our selection, as shown
in Figure 6. As mentioned earlier,
economically significant rules are
designated as such because of their
potential impact on the economy, the
environment, public health, or other factors.
According to the ORPM's director, decisions made at the political level result in
skipped milestones that OP career staff designated as moot. For example, Agency
staff said that in one economically significant rule, its moot designation resulted
from decisions or directives by political personnel and were beyond the
workgroup's control.
Interviewees Want Clarity on Moot or No Use of Moot Designations
There was confusion regarding the meaning and usage of moot designations
among the six OP analysts we interviewed. For example, three analysts suggested
that additional guidance and a process for utilizing the moot designation was
needed, and two analysts indicated that formally waiving milestones per ADP
Guidance is a better, more appropriate approach. Workgroup chairs interviewed
on selected rulemakings were also unaware of the meaning of moot designations.
Two OP analysts and a representative from a core office said that the term should
not exist as part of the ADP. While not explicitly supporting the use of moot
designations, one interviewee noted that, as a manager of the ADP, it was the
OP's prerogative to introduce and accept such designations.
Lack of Documentation in ADP Tracker Hindered Adherence
Determinations
The OP uses ADP Tracker to manage all actions that follow the ADP, and ADP
Tracker training describes the system as the EPA's database for managing and
tracking regulatory documents and information. ADP Tracker system goals
include tracking milestones and workflow and managing workgroups. However,
we noted missing and inconsistent documentation. Federal and EPA record-
keeping requirements apply to regulatory decisions, and a March 2017
administrator memorandum requires program and regional offices to report all
Figure 6: OMB-significance level
for rules with moot designations
Source: OIG analysis. (EPA OIG
graphic)
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regulatory actions in a management system. Additionally, while a 2013
memorandum to all RSC members generally required program office staff to
upload materials associated with four major milestones into ADP Tracker, we
found that ADP Tracker contained less than half of major milestone
documentation for 30 of 58 rulemakings (52 percent). Our assessment of the
EPA's adherence to the ADP was inhibited by poor data quality and a lack of
complete documentation in the ADP Tracker database. We also noted issues with
ADP Tracker information related to reliability, integrity, usability, and
authenticity.
The OP and the EPA's Records Center do not consider ADP Tracker an official
records-management system, and the OP's senior leaders said the system was
never intended to house "all" information on every rule. Program office staff
responsible for entering information into ADP Tracker said that they include
different levels of documentation, from dates to uploading decision documents.
They also noted challenges in keeping information in the database up-to-date
because of turnover and heavy workloads. We also found that the OP does not
formally monitor the system for data quality but rather revises dates as necessary
when generating reports for the Semiannual Regulatory Agenda. We agree that
not all information needs to be captured in ADP Tracker. However, the ADP
Guidance, ADP training, administrator memorandums, and the 2013 RSC
memorandum explicitly require tracking information on the four major ADP
milestones. This information is used to update the EPA's senior managers, the
OMB, and Congress.
Federal and EPA Record-Keeping Requirements Include Regulatory
Decisions
Federal employees are required to maintain
federal records per the Federal Records Act.
Specifically, 44 U.S.C. § 3101 requires the
head of every federal agency to "make and
preserve records containing adequate and
proper documentation of the organization,
functions, policies, decisions, procedures,
and essential transactions of the agency and
designed to furnish the information
necessary to protect the legal and financial
rights of the Government and of persons
directly affected by the agency's activities."
National Archives and Records
Administration regulations, specifically
36 C.F.R. § 1222.22, state that:
A record "includes all recorded
information ... made or received by a
Federal agency under Federal law or
in connection with the transaction of
public business and preserved or
appropriate for preservation by that
agency ... as evidence of the
organization, functions, policies,
decisions, procedures, operations, or
other activities of the United States
Government or because of the
informational value of data in them."
44 U.S.C. § 3301(a)
To meet their obligation for adequate and proper documentation,
agencies must prescribe the creation and maintenance of records
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that: . . . (e) Document the formulation and execution of basic
policies and decisions and the taking of necessary actions,
including all substantive decisions and commitments reached
orally (person-to-person, by telecommunications, or in conference)
or electronically.
Implementing this regulatory provision, the EPA's Interim Records Management
Policy states that:
EPA must properly and adequately document Agency business in
accordance with [National Archives and Records Administration]
NARA regulations. To meet these obligations, EPA employees and
non-employees who manage records must create and maintain
records that: . . . Document the formulation and execution of basic
policies and decisions and the taking of necessary actions,
including all substantive decisions and commitments reached
orally (person-to-person, by telecommunications, or in conference)
or electronically.
Although ADP Tracker is not an official records-management system, inputs to
ADP Tracker document regulatory decisions and actions and, therefore, constitute
Agency records. According to EPA Records Schedule 1023, these types of
"nonsubstantial rulemaking records" may be closed at the end of the calendar year
or upon completion of the relevant action and destroyed 20 years after file
closure.
Additionally, EPA and National Archives and Records Administration sources
note four components of trustworthy records: reliability, authenticity, integrity,
and usability.
OP Should Oversee Data Accuracy in ADP Tracker
The ORPM maintains the ADP Tracker system. While the OP oversees the
system as overall process manager for the ADP, the OP shares system data-entry
responsibility with program offices. According to the OP's ADP Tracker Data
Entry Responsibilities guidance, dated August 15, 2013, the lead office
developing or revising an action is ultimately responsible for the accuracy,
consistency, and completeness of the data in ADP Tracker. If the lead office is
unable to update its data in a timely fashion, the OP can update particular data
fields when necessary for accurate reporting to the EPA's senior managers, the
OMB, Congress, or others. Such OP updates do not negate the lead office's
responsibility for overall data integrity, nor does it mean that the OP has assumed
ongoing responsibility for the data fields that were updated. Additionally, the OP
is responsible for entering process-management data—which are items like moot
designations and waiver approvals for which the OP is the decision-maker—and
for interacting with the OMB.
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In a March 24, 2017 memorandum, then-Administrator Scott Pruitt said that "to
both expand and improve our internal mechanisms for information sharing,"
Agency offices "shall report all regulatory actions in the agency's regulatory
management system." He added that "[ojfficials entering information in the
system must certify its accuracy and update the information in a timely manner."
Per then-Administrator Pruitt, these efforts would help the EPA, "as one of the
most active regulatory agencies in federal government," ensure that its
policymaking process is of the highest quality. In his August 2018 memorandum
on the EPA's internal regulatory development process, then-Administrator
Wheeler further emphasized vigilantly on reviewing and updating information in
the EPA's regulatory tracking system.
OP senior leaders emphasized the role of the program offices in maintaining
documentation on rules. They also noted that the rulemaking docket is the official
repository for documentation of substantive decisions made during the
rulemaking process, but it does not house information about the four major ADP
milestones because these milestones pertain to the EPA's internal process rather
than substantive support for rules' contents. Additionally, the ORPM director said
that the ADP tracker has the capability to house various documents but that
offices are not consistently utilizing that capability. Since the OP is within the
Office of the Administrator and it oversees ADP Tracker, the OP is responsible
for reinforcing documentation expectations and system capabilities with program
offices and periodically monitoring the system for data quality.
Most Selected Rulemakings Lacked Milestone Documentation in ADP
Tracker
As noted above, the 2013 RSC memorandum generally required program office
staff to upload materials associated with four major milestones for Tier 1 and
Tier 2 actions—early guidance, analytic blueprint, options selection, and final
agency review—into ADP Tracker. The 2013 RSC memorandum specified that
lead program office staff are required to upload key documents supporting early
guidance, analytic blueprints, and options selection, while OP staff are required to
upload final agency review summary memorandums. Moreover, some of these
same documents were noted as "products of quality actions" in OIG Report
No. 13-P-0167, Efficiency of EPA's Rule Development Process Can Be Better
Measured Through Improved Management and Information, issued on
February 28, 2013. See Appendix B for details on this report.
Out of 58 rulemakings, 30 (52 percent) had less than half of major milestone
documentation in ADP Tracker (Figure 7). For this analysis, we accepted
documentation, such as meeting summary memorandums, decision documents,
final agency review memorandums, and any detailed analytic blueprint. We also
accepted alternative documentation that provided evidence of the content of
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milestone meetings, dates when meetings occurred, and meeting attendees.
Incomplete documentation was not accepted as evidence of milestone completion.
Figure 7: Use of ADP Tracker for required documents on major milestones
Percentage of documents
n ADP Tracker
100%
99-75%
49-25%
24-1%
I 1 1 1 1
0 5 10 15 20
Number of rules
(out of 58 total rules)
Source: OIG analysis. (EPA OIG graphic)
Out of the 58 rules we reviewed, five had an ANPRM, 55 had a NPRM, and 27 had
a final rulemaking phase. We found the following:
• ANPRM—For the five rulemakings that should have had documentation on
key milestones in ADP Tracker, four rulemakings, or 80 percent, had less
than half of the required items in the system. ADP Guidance notes that
ANPRM follows the ADP at the appropriate tier level.
• NPRM—For the 55 rulemakings that should have had documentation on
key milestones in ADP Tracker, 29 rulemakings, or 53 percent, had less
than half of the required items in the system.
• Final—For the 27 rulemakings that should have had documentation on key
milestones in ADP Tracker, 13 rulemakings, or 48 percent, had less than
half of the required items in the system.
Our analysis identified 11 rulemakings that had all (100 percent) of required
major milestone documentation in ADP Tracker.
Concerns on Trustworthiness of Some Documentation
in ADP Tracker
ADP Tracker houses internal decision points on the Agency's rulemakings, and
internal stakeholders should be able to rely on the information pertaining to those
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decisions. As stated previously, the EPA and the National Archives and Records
Administration state that the four components of trustworthy records are
reliability, authenticity, integrity, and usability. "Reliability" includes having a
full and accurate representation of all transactions, activities, or facts to which the
records attest and can be depended upon during subsequent transactions or
activities. Information in records must be complete and unaltered to preserve its
integrity. Usable information in records must be retrieved, presented, located, and
interpreted when needed. "Authentic information" in records can be proven to be
what it claims to be, have been created or sent by the persons claiming to have
created or sent it, and have been created or sent at the claimed time.
Using the above definition, we identified data quality issues in the ADP Tracker
database, including:
• Decisions from the various program offices and the OP were not officially
documented and maintained. For example, because of decisions being
made at a high-organizational level and a subsequent lack of
documentation of those decisions, interviewees were unaware of the
ultimate status of milestones reflected in ADP Tracker.
• Information in ADP Tracker was incorrect, missing, or outdated. For
example, for the six rules that had waivers after the administrator released
his 2018 memorandum, four were not marked as "waived" but rather as
"completed." Other areas in ADP Tracker were also mislabeled. Over a
dozen rules had discrepancies between dates or milestone status noted in
ADP Tracker and actual dates on source documents or status of milestones
provided by program offices.
• Confusion from EPA staff, in response to our document request, on
whether ADP Tracker accurately showed milestones as waived or as
designated moot. For example, one response indicated "waived as moot."
• Difficulty in locating or retrieving requested documentation.
• At least one instance of a milestone backdated to depict subsequent
milestones as on track.
EPA staff responsible for entering data into ADP Tracker said that there are few
individuals who are responsible for keeping milestones updated in the database.
They added that there is at least one office that does not have a dedicated person
in that role and that office has struggled to keep up with the ADP data-entry
responsibilities. Program office staff responsible for entering data each described
varying levels of documentation ranging from entering dates only to uploading
decision documents. They also noted challenges in keeping database information
updated because of turnover and heavy workloads.
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OP staff said that the system always has some outdated data given that hundreds
of actions are in development at any given moment and each action has many data
fields. OP managers said there is no realistic scenario in which all the data in ADP
Tracker are accurate and current. The ORPM's director added that these
challenges exist for information management systems generally and are not
unique to ADP Tracker.
Interviewees Expressed Support for Using ADP Tracker for Its Fullest
Capabilities
Three OP staff we interviewed indicated that ADP Tracker could be better utilized
and more accurate and complete. Other interviewees, such as rule workgroup
chairs, said they use ADP Tracker inconsistently. Additionally, one RSC member
said that the system could include not only dates but also all memorandums,
waiver requests, and documentation generated for rulemakings. OP managers said
nothing prevents offices from fully utilizing ADP Tracker and that the OP
emphasizes this and periodically monitors the system as ADP managers.
The EPA plans to transition from ADP Tracker to the EPA Action Management
System during the summer of 2021; however, absent consistent data entry and
monitoring for data quality, the new system may include the same types of errors
and deficiencies we identified. Rulemaking is fundamental to the Agency's
mission. Improved oversight of the tracking database could help the EPA achieve
its objectives of efficiently and effectively managing the ADP.
ADP Training Should Be Improved
According to the OP's website, the ORPM manages the EPA's action
development and review process and provides comprehensive action development
training for EPA staff and managers. The workgroup chairs we interviewed
recalled few specific, formal ADP training opportunities and said that most
training has been on-the-job and through self-paced training and webinars on the
OP's ADP Library. One OP analyst told us that new political appointees used to
be briefed on the ADP, but the analyst did not note the status of this training for
new political appointees. The OP said that the ORPM director has briefed
political appointees and that individual program offices can also provide training
within their own organizations or request that the OP provide training. The OP
previously held a formal, in-person, three-day training course for staff at least
annually, but that training has not been held in several years because of resource
constraints, staff unavailability, and competing demands. OP managers added that
there have been requests from EPA staff to move away from more formal training
in Washington, D.C., to online, module-style training.
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In our analysis of 58 rules and through our interviews, we noted situations that
demonstrate, in part, the impact of not having training, including:
• The OP staff needing to remind workgroups of what to do to comply with
the ADP. One OP analyst said most workgroup chairs are not familiar
with the ADP process.
• Cross-media offices, which are invited to participate in workgroups for all
Tier 1 and Tier 2 actions, may be perceived as less important than other
offices and their input may not always be appropriately considered during
rulemakings. For example, staff and managers we interviewed in the
Office of Children's Health Protection said that their office is often
forgotten or left out of the process. Both the OIG and the GAO have
reported on the need to consider children's health in rulemaking
(Appendix B).
• EPA staff did not fully document some ADP milestones.
• As noted above, interviewees were confused on the difference between
waivers and moot designations.
Given the significance of rulemaking as one of the EPA's primary tools to protect
human health and the environment, familiarity with the ADP is critical for the
Agency's success in achieving its mission. The ADP is a complex process
involving many different internal stakeholders; steps; and a myriad of
considerations, such as executive orders to consider children's health and
environmental justice impacts. The EPA relies on staff to develop high-quality
rules to accomplish their missions. Training could help provide consistent ADP
application and give Agency staff the breadth and depth of knowledge it takes to
develop quality actions.
Conclusion
As the Agency notes in its ADP Guidance, much of the EPA's environmental
success and organizational credibility are directly linked to the quality of the
EPA's active regulatory work. Taking action to address ADP nonadherence,
confusion on milestone designations, tracking system documentation, and training
could enhance the credibility of the Agency's rulemaking process. Regulations
that are based on sound science, promote economic efficiency, and are
implementable and enforceable allow the EPA to achieve its mission to protect
human health and the environment.
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Recommendations
We recommend that the associate administrator for Policy:
1. On an annual basis, reinforce the expectation that the Action Development
Process will be followed for all regulatory actions, including procedures to
waive milestones for Tier 1 and Tier 2 actions.
2. Query key internal rulemaking stakeholders, such as the Regulatory Steering
Committee, workgroup chairs, and Office of Policy staff, on the use of the
moot designation and determine whether the designation is necessary and
appropriate. If a decision is made to use the moot designation, define moot,
clarify its applicability, and institute documentation requirements for using the
moot designation in the Action Development Process.
3. Define for program offices the key regulatory decisions and information that
offices are expected to include in the Action Development Process tracking
database.
4. In coordination with program offices, develop a plan to improve oversight of
the Action Development Process tracking database that includes periodic
assessments or system checks to verify that the database includes identified
key regulatory decisions and information.
5. Query EPA staff, through Regulatory Steering Committee representatives, on
the adequacy of existing Action Development Process training and revise
training methods and reallocate resources for training as needed.
Agency Response and OIG Assessment
While the Agency agreed with our recommendations and provided corrective
actions and completion dates for all recommendations, more specific details are
required to resolve recommendations. Specifically:
• Recommendation 1 previously stated, "On an annual basis, reinforce the
EPA administrator's expectation that the Action Development Process will
be followed for all regulatory actions, including procedures to waive
milestones for Tier 1 and Tier 2 actions." We struck reference to the EPA
administrator given the change in administration. In its response, the OP
said that the incoming administrator "will issue a memo affirming the
importance of the Action Development Process." Additionally, per our
recommendation, the OP as ADP managers should annually reinforce
adherence to the process and waiver procedures. This recommendation is
unresolved pending clarity on the OP's annual efforts to reinforce the
ADP in addition to the new administrator's memorandum.
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• The OP's planned corrective action partially addresses Recommendation 2
on querying internal rulemaking stakeholders but does not address specific
steps we noted once a decision is made regarding the use of moot
designations. The estimated completion date in the OP's response is
unclear whether it is for the first part or the full recommendation. As such,
this recommendation is unresolved.
• Recommendation 3 is resolved with corrective actions pending. We note,
however, that our recommendation is not dependent on development of
the EPA Action Management System and that key information should be
defined for ADP Tracker if the transition to the new system extends
beyond the OP's estimated completion date.
• The OP's planned corrective actions for Recommendation 4 to "initiate a
discussion" on a plan does not meet the intent of our recommendation to
"develop a plan" that includes periodic assessments or system checks to
verify that the ADP tracking database includes identified key regulatory
decisions and information. As such, this recommendation is unresolved.
• Recommendation 5 is unresolved pending evidence of the OP's training
survey results and training plan adjustments.
Additionally, the OP provided general feedback on the content of the draft report
for our consideration. While we acknowledge that the ADP Guidance is an
internal document and represents an expected, but not mandatory, process for
developing EPA regulatory actions, we also note that the ADP is the Agency's
decades-old process for developing regulatory actions and that decisions and
actions resulting from ADP milestones are regulatory decisions.
The OP's response also noted that ADP Tracker is not a record-keeping system.
We agreed and reiterate, however, that ADP Tracker includes records of the
Agency's regulatory decisions and major milestones. Therefore, the designation
of ADP Tracker as an information tracking system has no bearing on whether
information input to that system includes records nor on the retention schedule
applicable to those records.
Finally, the OP's response included comments on the methodology used for this
report. For example, due to the inconsistent data entry, we could not solely rely on
ADP Tracker information on milestone meetings. The Agency correctly asserts
that if there was no documentation of such a meeting occurring, we did not
consider it as adhering to the ADP. We did consider a range of documentation as
appropriate when assessing ADP milestone adherence. The OP also notes that it is
within the administrator's discretion to provide direction outside the context of
the formal ADP milestone meetings. We agree and noted the importance of
documenting these decisions as part of the Agency's established process for
developing quality actions. The Agency's full response to our draft report is in
Appendix E.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Potential
Planned
Monetary
Rec.
Page
Completion
Benefits
No.
No.
Subject
Status1
Action Official
Date
(in $000s)
26 On an annual basis, reinforce the expectation that the Action
Development Process will be followed for all regulatory actions,
including procedures to waive milestones for Tier 1 and Tier 2
actions.
27 Query key internal rulemaking stakeholders, such as the
Regulatory Steering Committee, workgroup chairs, and Office of
Policy staff, on the use of the moot designation and determine
whether the designation is necessary and appropriate. If a
decision is made to use the moot designation, define moot,
clarify its applicability, and institute documentation requirements
for using the moot designation in the Action Development
Process.
27 Define for program offices the key regulatory decisions and
information that offices are expected to include in the Action
Development Process tracking database.
27 In coordination with program offices, develop a plan to improve
oversight of the Action Development Process tracking database
that includes periodic assessments or system checks to verify
that the database includes identified key regulatory decisions
and information.
27 Query EPA staff, through Regulatory Steering Committee
representatives, on the adequacy of existing Action Development
Process training and revise training methods and reallocate
resources for training as needed.
Associate Administrator
for Policy
Associate Administrator
for Policy
Associate Administrator
for Policy
Associate Administrator
for Policy
Associate Administrator
for Policy
9/30/21
1C = Corrective action completed.
R = Recommendation resolved with corrective action pending.
U = Recommendation unresolved with resolution efforts in progress.
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Appendix A
Internal Control Assessment
This table identifies which internal control components and underlying principles are significant
to our audit objectives.
Which internal control components are
significant to the audit objectives?
Wh
ob
lich internal control principles are significant to the audit
ectives?
X
Control Environment
The foundation for an internal control
system. It provides the discipline and
structure to help an entity achieve its
objectives.
X
1. The oversight body and management should
demonstrate a commitment to integrity and ethical
values.
X
2. The oversight body should oversee the entity's internal
control system.
3. Management should establish an organizational
structure, assign responsibilities, and delegate authority
to achieve the entity's objectives.
4. Management should demonstrate a commitment to
recruit, develop, and retain competent individuals.
X
5. Management should evaluate performance and hold
individuals accountable for their internal control
responsibilities.
X
Risk Assessment
Management assesses the risks facing the
entity as it seeks to achieve its objectives.
This assessment provides the basis for
developing appropriate risk responses.
X
6. Management should define objectives clearly to enable
the identification of risks and define risk tolerances.
X
7. Management should identify, analyze, and respond to
risks related to achieving the defined objectives.
X
8. Management should consider the potential for fraud
when identifying, analyzing, and responding to risks.
X
9. Management should identify, analyze, and respond to
significant changes that could impact the internal
control system.
X
Control Activities
The actions management establishes
through policies and procedures to achieve
objectives and respond to risks in the
internal control system, which includes the
entity's information system.
X
10. Management should design control activities to achieve
objectives and respond to risks.
X
11. Management should design the entity's information
system and related control activities to achieve
objectives and respond to risks.
X
12. Management should implement control activities
through policies.
X
Information and Communication
The quality information management and
personnel communicate and use to
support the internal control system.
13. Management should use quality information to achieve
the entity's objectives.
X
14. Management should internally communicate the
necessary quality information to achieve the entity's
objectives.
15. Management should externally communicate the
necessary quality information to achieve the entity's
objectives.
X
Monitoring
Activities management establishes and
operates to assess the quality of
performance overtime and promptly
resolve the findings of audits and other
reviews.
X
16. Management should establish and operate monitoring
activities to monitor the internal control system and
evaluate the results.
X
17. Management should remediate identified internal
control deficiencies on a timely basis.
Source: Based on internal control components and principles outlined in GAO-14-704G, Standards for Internal
Control in the Federal Government (also known as the "Green Book"), issued September 10, 2014.
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Appendix B
Detailed Scope and Methodology
Rule Review Checklist and Selected Rulemakings
We used the A DP Guidance to develop a 15-step checklist to assess selected rulemakings for
ADP adherence, repeating some steps for applicable phases of the rulemaking process, such as
ANPRM, NPRM, and final, for a total of 38 checklist items to assess. Appendix C contains the
checklist we used to assess ADP adherence.
We used two rules to test our checklist methodology—one randomly selected from the OAR and
one randomly selected from the group of OCSPP, OLEM, and OW rules. Our selected
rulemakings originally included 86 Tier 1 and Tier 2 rules tiered during fiscal years 2015
through 2019 or from October 1, 2014, through September 30, 2019. We excluded the proposed
rule "Repeal of Emission Requirements for Glider Vehicles, Glider Engines, and Glider Kits,"
82 Fed. Reg. 53442 (November 16, 2017), which the OIG had audited per a congressional
request, resulting in 85 rules for analysis. This group included high-profile rules explicitly
subject to the ADP per the ADP Guidance and a mix of in-process and completed rules to
illustrate different stages of the ADP. Because some rules were ongoing during our audit:
• We did not review any documents on our selected rulemakings developed after
January 22, 2020, when we first met with the OP about this topic.
• Information, such as Executive Order 12866 significance or tiering level, may have
changed since we initiated our audit.
TheADP Guidance was updated in 2015 and again in 2018 with minor changes. Therefore,
when creating the checklist and evaluating the rules, the team made no distinction between the
versions. The checklist focuses on items that were consistent between the two versions.
Items included in the checklist are:
• Significant milestones or milestones required for all Tier 1 and Tier 2 rulemakings, such
as tiering, early guidance, and options selection as described in Tables 1 and 2 in
Chapter 1.
• Areas of concern in the ADP from prior OIG work, such as workgroup involvement and
analytic blueprint development.
• ADP steps to comport with OMB and other regulatory requirements, such as an
appropriate signing official and submission to Congress and the GAO, before the rule
takes effect.
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More information on the items above is described in the following flowchart (Figure A-l) that
depicts the EPA's A DP for Tier 1 and Tier 2 actions.
Figure A-1: ADP for Tier 1 and Tier 2 actions
Source: EPA ADP Library process flowchart "General Process for Tier 1 & 2 Proposed Rules."
(EPA graphic)
After requesting the supporting documentation for the checklist items from either the OP or
program offices, we learned that some items were too burdensome to provide, time limitations
did not allow for sufficient OIG review, or hard-copy documents could not be retrieved from
EPA headquarters because of the coronavirus pandemic. Therefore, we decided not to pursue
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collecting the supporting documentation and we excluded corresponding checklist items,
resulting in the final 15-step checklist we used for our analysis.
After completing initial checklists on each of the 85 rulemakings, we developed three criteria to
exclude a group of rules from our summary analysis. Criteria included:
• The only milestone that occurred before January 22, 2020, was tiering and a workgroup
may or may not have been formed.
• The rulemaking was withdrawn or canceled from the regulatory agenda before ANPRM
(if applicable) or being published in the Federal Register during NPRM.
• The rulemaking was a minor wording change or extension of effective date.
Using these exclusion criteria, the full checklist and summary analysis applied to 58 rules.
Appendix D lists both the rules we analyzed and those we excluded.
For each selected rulemaking, we reviewed available information in ADP Tracker and requested
and reviewed needed documentation from the OP and rule workgroup chairs or points of contact.
As needed, we interviewed OP analysts and workgroup chairs or points of contact to ask rule-
specific questions to verify information on activities and decisions. We did not perform analysis
to determine the statistical significance of any differences we observed, and average percent
adherence values should not be extrapolated to all EPA rulemakings.
Throughout our audit, we noted inaccurate or incomplete information in ADP Tracker for our
selected rulemakings. We also heard concerns from interviewees about the accuracy and
completeness of information in ADP Tracker. Chapter 3 of this report summarizes shortcomings
we noted with the EPA's ADP Tracker system. We used ADP Tracker information to the extent
we could, though not solely (except to determine the tiering date of an action as we could not
access tiering forms because of the coronavirus pandemic), and we sought as much additional
documentation as practicable outside of ADP Tracker to support our findings and conclusions.
Prior Audit Coverage
We reviewed prior relevant reports issued by our office and the GAO, including:
• OIG Report No. 20-P-0047, EPA Failed to Develop Required Cost and Benefit
Analyses and to Assess Air Quality Impacts on Children's Health for Proposed Glider
Repeal Ride Allowing Used Engines in Heavy-Duty Tracks, issued on
December 5, 2019. The OIG found that the EPA did not follow the ADP in
developing the proposed Glider Repeal Rule, nor did it meet Federal Records Act
requirements. The OIG noted that, according to EPA managers and officials, then-
Administrator Pruitt directed that the Glider Repeal Rule be promulgated as quickly
as possible and that he directed the OAR to develop the proposed rule without
conducting the analyses required by the executive orders. The OIG found that the lack
of analyses caused the public to not be informed of the proposed rule's benefits, costs,
potential alternatives, and impacts on children's health during the public comment
period. Among other recommendations, the OIG recommended that the EPA
document decisions, including substantive decisions reached orally; comply with
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applicable record-keeping and docketing requirements, including those found in the
Federal Records Act; and comply with both the EPA's Interim Records Management
Policy and theADP Guidance. The Agency agreed to implement corrective actions to
address two of the three recommendations. As of September 30, 2020, the third
recommendation remains unresolved.
• OIG Report No. 13-P-0167. Efficiency of EPA's Rule Development Process Can Be
Better Measured Through Improved Management and Information, issued on
February 28, 2013. The OIG found that the EPA had limitations in rulemaking
documentation and guidance, and the Agency was unable to evaluate the efficiency of
the rulemaking process or identify delays in its rulemaking activities. Some
limitations included tracking and documentation, which challenged the Agency's
ability to monitor, evaluate, and assure the efficiency of EPA rulemaking. The OIG
found that the EPA's database for creating and tracking rules was sparsely populated
and did not contain the necessary documents or information to allow the team to
complete its review. The OIG found program offices were not adequately utilizing the
Agency's database because of a lack of standardized procedures from the OP
describing who was responsible for uploading the developmental documents to the
databases used to manage the ADP process. The OIG recommended that the associate
administrator for OP establish guidance, maintain database documentation, and track
resources to enhance the Agency's ability to determine the efficiency of the
rulemaking process. Corrective actions were completed for all three of the report's
recommendations.
• GAP-18-22. Federal Regulations: Key Considerations for Agency Design and
Enforcement Decisions, dated October 19, 2017. The GAO found that the EPA's
procedures require that enforcement officials participate in ADP rule-drafting groups
for rules involving "precedent-setting policy implications" and "extensive cross-
agency participation." The GAO also found that the Office of Enforcement and
Compliance Assurance's training and guidance materials encouraged rule writers to
incorporate compliance principles, such as clarity, consistency, and transparency, into
their decision-making and consider how regulatory design choices can influence later
compliance and need for enforcement. The report made no recommendations.
• GAO-13-254. Environmental Health: EPA Has Made Substantial Progress but Could
Improve Processes for Considering Children's Health, dated August 12, 2013. The
GAO found that the EPA could not be assured that it had thoroughly addressed risks
to infants and children because the Agency neither systematically evaluated nor
consistently documented how it considered children's health risks in rulemaking. The
GAO also found that the EPA had not taken the steps necessary to improve the Office
of Children's Health Protection's ability to use the rulemaking system efficiently to
identify actions involving children's health, such as which regulatory workgroups
would be appropriate for staff participation. The EPA agreed with the GAO's
recommendation that the EPA require lead program offices to document their
decisions in rulemakings and other actions regarding how health risks to children
were considered. According to the GAO's website, the corrective actions have been
implemented.
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Appendix C
01G Checklist Used to Assess ADP Adherence
Item*
Question
Number
Question Wording
General
1
Q1
When was the rulemaking tiered?
2
Q2
Was a workgroup formed for the rulemaking?
3
Q5
Were executive orders and applicable analyses addressed in the rulemaking's
preamble?
4
Q15
Was the final rule submitted to the Congress and the GAO before it took effect?
ANPRM
5
Q3(A)
Did an early guidance meeting or approved waiver occur?
6
Q4(A)
Was an analytic blueprint developed?
7
Q6(A)
Did an options selection meeting or approved waiver occur?
8
Q7(A)
Was a final Agency review meeting held for the rulemaking?
9
Q8(A)
At the final Agency review, were the written positions of the AAs/RAs represented to
the workgroup chair, RSC representative, and the appropriate Regulatory
Management Division desk officer?
10
Q9.1 (A)
If one nonconcurrence occurred and no agreement was reached on how to proceed,
did the lead office include the comments in the Action Memorandum with an
explanation of why it could not satisfactorily address them?
11
Q9.2(A)
If more than one nonconcurrence occurred and no agreement was reached on how
to proceed, did OP alert the regulatory policy officer about the nonconcurrence?
12
Q10(A)
Was the rulemaking signed by the appropriate EPA official?
13
Q11 (A)
What was the date the docket was made publicly available?
14
Q12(A)
Was the docket made publicly available no later than the date of issuance/publication
of the action?
15
Q13(A)
Did the published rulemaking include instructions on when, where, and how to
submit public comments?
16
Q14(A)
Prior to final rule, did the workgroup consider significant public comments relevant to
the proposed rule or draft action submitted during the comment period (including new
information prompting reconsideration of options or supporting material)?
NPRM
17
Q3(N)
Did an early guidance meeting or approved waiver occur?
18
Q4(N)
Was an analytic blueprint developed?
19
Q6(N)
Did an options selection meeting or approved waiver occur?
20
Q7(N)
Was a final Agency review meeting held for the rulemaking?
21
Q8(N)
At the final Agency review, were the written positions of the AAs/RAs represented to
the workgroup chair, RSC representative, and the appropriate Regulatory
Management Division desk officer?
22
Q9.1 (N)
If one nonconcurrence occurred and no agreement was reached on how to proceed,
did the lead office include the comments in the Action Memorandum with an
explanation of why it could not satisfactorily address them?
23
Q9.2(N)
If more than one nonconcurrence occurred and no agreement was reached on how
to proceed, did OP alert the regulatory policy officer about the nonconcurrence?
24
Q10(N)
Was the rulemaking signed by the appropriate EPA official?
25
Q11(N)
What was the date the docket was made publicly available?
26
Q12(N)
Was the docket made publicly available no later than the date of issuance/publication
of the action?
27
Q13(N)
Did the published rulemaking include instructions on when, where, and how to
submit public comments?
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Item*
Question
Number
Question Wording
28
Q14(N)
Prior to final rule, did the workgroup consider significant public comments relevant to
the proposed rule or draft action submitted during the comment period (including new
information prompting reconsideration of options or supporting material)?
Final
29
Q3(F)
Did an early guidance meeting or approved waiver occur?
30
Q4(F)
Was an analytic blueprint developed?
31
Q6(F)
Did an options selection meeting or approved waiver occur?
32
Q7(F)
Was a final Agency review meeting held for the rulemaking?
33
Q8(F)
At the final Agency review, were the written positions of the AAs/RAs represented to
the workgroup chair, RSC representative, and the appropriate Regulatory
Management Division desk officer?
34
Q9.1 (F)
If one nonconcurrence occurred and no agreement was reached on how to proceed,
did the lead office include the comments in the Action Memorandum with an
explanation of why it could not satisfactorily address them?
35
Q9.2(F)
If more than one nonconcurrence occurred and no agreement was reached on how
to proceed, did OP alert the regulatory policy officer about the nonconcurrence?
36
Q10(F)
Was the rulemaking signed by the appropriate EPA official?
37
Q11 (F)
What was the date the docket was made publicly available?
38
Q12(F)
Was the docket made publicly available no later than the date of issuance/publication
of the action?
* Any item could have been considered "N/A" depending on the rule. Rulemakings were only evaluated against items
that applied to an individual rulemaking.
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Appendix D
Adherence of Selected Rulemakings
Table D-l lists the rules we reviewed and range of adherence, nonadherence, and undetermined
adherence. We categorized the table by applicable rulemaking phase, from the time of rule
tiering through January 22, 2020.
Table D-1: Reviewed rules and level of adherence
Rule title
Program
office
OMB
significance*
Yes
ADP adherence**
No Undetermined
ANPRM phase only
Methylene Chloride;
Commercial Paint and Coating
Removal Training, Certification
and Limited Access Program
OCSPP
Significant
92%
8%
0%
Increasing Consistency and
Transparency in Considering
Costs and Benefits in the
OP
Significant
70%
30%
0%
Rulemaking Process
Addition of Certain Per- and
Polyfluoroalkyl Substances to
the Toxics Release Inventory
OCSPP
Significant
64%
18%
18%
ANPRM and NPRM phases
Control of Air Pollution from
New Motor Vehicles: Heavy-
Duty Engine Standards
OAR
Nonsignificant
93%
7%
0%
ANPRM, NPRM, and final phases
Repeal of the Clean Power
Plan; Emission Guidelines for
GHG Emissions from Existing
Electric Utility Generating
Units; Revisions to Emission
OAR
Economically
Significant
74%
26%
0%
Guideline Implementing
Regulations
NPRM phase only
Financial Responsibility
Requirements under CERCLA
Section 108(b) for the
Petroleum and Coal Products
OLEM
Significant
100%
0%
0%
Manufacturing Industry
Financial Responsibility
Requirements under CERCLA
Section 108(b) for the
Chemical Manufacturing
Industry
OLEM
Significant
100%
0%
0%
Review of Dust-Lead Post-
Abatement Clearance Levels
OCSPP
Significant
100%
0%
0%
Control of Air Pollution From
Aircraft and Aircraft Engines:
Proposed GHG Emissions
OAR
Significant
100%
0%
0%
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Program OMB ADP adherence-
office significance* Yes No
Standards and Test
Procedures
Clean Energy Incentive
Program Design Details
OAR
Significant
100%
0%
0%
Endangerment Finding for
Lead Emissions from Piston-
OAR
N/A
100%
0%
0%
Engine Aircraft Using Leaded
Aviation Gasoline
Clean Water Act 404
OW
N/A
100%
0%
0%
Assumption Update Regulation
Trichloroethylene; Rulemaking
under Toxic Substances
Control Act Section 6(a); Vapor
Degreasing
OCSPP
Economically
Significant
92%
8%
0%
N-Methylpyrrolidone;
Regulation of Certain Uses
under TSCA Section 6(a)
OCSPP
Significant
92%
8%
0%
CERCLA Financial
Responsibility Requirements:
Electric Power Generation,
Transmission, & Distribution
Industry, Petroleum & Coal
OLEM
Significant
91%
9%
0%
Products Manufacturing
Industry, & Chemical
Manufacturing Industry
Peak Flows Management
OW
N/A
86%
14%
0%
Designating perfluorooctanoic
acid and
perfluorooctanesulfonic acid as
CERCLA Hazardous
OLEM
Significant
86%
0%
14%
Substances
Trichloroethylene Use in Dry
Cleaning and Aerosol
Degreasing -TSCA Section
6(a)
OCSPP
Significant
85%
15%
0%
Renewables Enhancement and
Growth Support Rule
OAR
Significant
83%
17%
0%
NESHAP: Miscellaneous
Organic Chemical
Manufacturing RTR
OAR
Significant
83%
0%
17%
Effluent Limitations Guidelines
and Standards for the Steam
Electric Power Generating
Point Source Category
OW
Economically
Significant
82%
18%
0%
Pesticides; Agricultural Worker
Protection Standard; Revision
of the Application Exclusion
OCSPP
Significant
82%
18%
0%
Zone Requirements
Increasing Consistency and
Transparency in Considering
Benefits and Costs in the
OAR
N/A
80%
0%
20%
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Program OMB ADP adherence-
office significance* Yes No
Clean Air Act Rulemaking
Process
NESHAP: Organic Liquids
Distribution (Non-Gasoline)
RTR
OAR
Nonsignificant
77%
8%
15%
Review of the National
Ambient Air Quality Standards
OAR
N/A
75%
25%
0%
for Particulate Matter
Clean Water Act Section
OW
N/A
75%
25%
0%
404(c) Regulatory Revision
Treatment of Biogenic Carbon
Dioxide Emissions under the
OAR
N/A
86%
14%
0%
Clean Air Act Permitting
Programs
Revisions to the Prevention of
Significant Deterioration and
Title V GHG Permitting
Regulations and Establishment
of a GHG Significant Emission
Rate for GHG Emissions
OAR
Significant
69%
31%
0%
Under the Prevention of
Significant Deterioration
Program
Decabromodiphenyl Ether;
Regulation of Persistent,
Bioaccumulative, and Toxic
OCSPP
Significant
69%
8%
23%
Chemicals Under TSCA
Section 6(h)
Fuels Regulatory Streamlining
OAR
N/A
63%
13%
25%
Office of
Strengthening Transparency in
Regulatory Science
Research
and
Development
Significant
50%
33%
17%
Modernizing the Administrative
Exhaustion Requirements for
Permitting Decisions and
Streamlining Procedures for
Permit Appeals
Office of
General
Counsel
Nonsignificant
45%
27%
27%
NPRM and Final Phases
Oil and Natural Gas Sector:
Emission Standards for New,
Reconstructed, and Modified
Sources Reconsideration
OAR
Economically
Significant
100%
0%
0%
NESHAP: Generic Maximum
Achievable Control Technology
Standards RTR for Ethylene
OAR
Nonsignificant
100%
0%
0%
Production
NESHAP: Integrated Iron and
Steel Manufacturing Facilities
RTR
OAR
Nonsignificant
100%
0%
0%
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Program OMB ADP adherence-
office significance* Yes No
Implementation of the 2015
National Ambient Air Quality
Standards for Ozone: State
OAR
Significant
95%
5%
0%
Implementation Plan
Requirements
Clean Water Act Hazardous
Substances Spill Prevention
OLEM
Nonsignificant
95%
5%
0%
NESHAP: Site Remediation
RTR
OAR
Nonsignificant
93%
7%
0%
Supplemental Finding that it is
Appropriate and Necessary to
Regulate Hazardous Air
Pollutants from Coal- and Oil-
OAR
Significant
91%
9%
0%
Fired Electric Utility Steam
Generating Units
Oil and Natural Gas Sector:
Emission Standards for New,
Reconstructed, and Modified
OAR
Significant
87%
13%
0%
Sources Review
Procedures for Evaluating
Existing Chemical Risks under
OCSPP
Significant
82%
18%
0%
the TSCA
Renewable Fuel Volume
Standards for 2019 and
Biomass-Based Diesel Volume
OAR
Economically
Significant
82%
18%
0%
for 2020
Review of Standards of
Performance for GHG
Emissions from New, Modified,
and Reconstructed Stationary
OAR
Significant
81%
19%
0%
Sources: Electric Utility
Generating Units
Prevention of Significant
Deterioration and
Nonattainment New Source
OAR
Significant
80%
20%
0%
Review: Project Emissions
Accounting
Model Trading Rules for GHG
Emissions from Electric Utility
Generating Units Constructed
OAR
Significant
83%
17%
0%
on or Before January 8, 2014
Municipal Separate Storm
Sewer System General Permit
Remand Rule
OW
Significant
77%
14%
9%
Renewable Fuel Volume
Standards for 2017 and
Biomass-Based Diesel Volume
OAR
Economically
Significant
77%
23%
0%
for 2018
Renewable Fuel Volume
Standards for 2018 and
Biomass-Based Diesel for
2019
OAR
Economically
Significant
77%
23%
0%
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Program OMB ADP adherence-
office significance* Yes No
Modifications to Fuel
Regulations to Provide
Flexibility for E15;
Modifications to Renewable
Fuel Standard Renewable
Identification Number Market
Regulations
OAR
Significant
77%
5%
18%
Procedures for Prioritization of
Chemicals for Risk Evaluation
under the TSCA
OCSPP
Significant
76%
24%
0%
Amendments to Implementing
Regulations for Reviewing and
Acting on Clean Air Act Section
111 (d) State Plans
OAR
Nonsignificant
76%
6%
18%
Methylene Chloride;
Regulation of Paint and
Coating Removal for
Consumer Use Under TSCA
Section 6(a)
OCSPP
Significant
73%
18%
9%
Repeal of Carbon Pollution
Emission Guidelines for
Existing Stationary Sources:
Electric Utility Generating Units
OAR
Economically
Significant
67%
33%
0%
NESHAP: Coal- and Oil-Fired
Electric Utility Steam
Generating Units-
Reconsideration of
Supplemental Cost Finding
and RTR
OAR
Significant
65%
24%
12%
Renewable Fuel Standard
Program: Standards for 2020,
Biomass-Based Diesel
Volumes for 2021, and Other
Changes
OAR
Significant
63%
0%
37%
Definition of "Waters of the
United States" - Recodification
of Preexisting Rules
OW
Economically
Significant
57%
24%
19%
The Navigable Waters
Protection Rule: Definition of
"Waters of the United States"
OW
Significant
44%
31%
25%
The Safer Affordable Fuel-
Efficient Vehicles Rule for
Model Years 2021-2026
Passenger Cars and Light
Trucks
OAR
Economically
Significant
44%
56%
0%
Source: OIG analysis. (EPA OIG table)
'According to publicly available sources such as reginfo.gov.
** "Yes" includes percent of checklist items that adhered to the ADP (includes approved waivers), "no" includes
percent checklist items that did not adhere to the ADP (includes moot steps), and "undetermined" is unable to
determine ADP adherence due to a lack of documentation.
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Table D-2 lists the rules excluded from analysis and the reason for their exclusion.
Table D-2: Rules excluded from analysis and criteria for exclusion
Rule title
Program
office
Applicable exclusion
criteria*
Federal Plan Requirements for GHG Emissions from
Electric Utility Generating Units Constructed on or
Before January 8, 2014
OAR
2
Development of Significant Impact Level for Ozone in
Prevention of Significant Deterioration Regulations
OAR
2
NESHAP for Coke Ovens: Pushing, Quenching, and
Battery Stacks
OAR
2
Emission Guidelines for the Existing Oil and Natural
Gas Sector
OAR
2
Standards of Performance for Glass Manufacturing
Plants
OAR
1
Reconsideration of Standards of Performance and
Emission Guidelines for Municipal Solid Waste
Landfills
OAR
1
Renewable Fuel Standard Program: Modification of
Statutory Volume Targets
OAR
2
Review of Primary National Ambient Air Quality
Standards for Ozone
OAR
1
On-Highway Heavy-Duty Trailers: Review of
Standards and Requirements
OAR
1
NESHAP: Generic Maximum Achievable Control
Technology II - Cyanide Chemicals Manufacturing
RTR
OAR
1
NESHAP: Primary Magnesium Refining RTR
OAR
1
NESHAP: Primary Copper Smelting RTR
OAR
1
NESHAP: Carbon Black Production RTR
OAR
1
NESHAP: Generic Maximum Achievable Control
Technology Standards for Spandex Production RTR
OAR
1
NESHAP: Semiconductor Manufacturing RTR
OAR
1
NESHAP: Flexible Polyurethane Foam Fabrication
Operations RTR and Flexible Polyurethane Foam
Production and Fabrication Area Sources Technology
Review
OAR
1
NESHAP: Refractory Products Manufacturing RTR
OAR
1
NESHAP: Mercury Cell Chlor-Alkali Plants RTR
OAR
1
NESHAP: Chemical Manufacturing Area Source
Technology Review
OAR
1
Advancing Clean Aircraft Engines and Reforming
Particulate Matter Test Procedures Under Clean Air
Act Section 231
OAR
1
Pesticides; Certification of Pesticide Applicators Rule;
Reconsideration of the Minimum Age Requirements
OCSPP
2
Pesticides; Certification of Pesticide Applicators Rule;
Extension of Effective Date
OCSPP
3
Polychlorinated Biphenyls; Reassessment of Use
Authorizations for Polychlorinated Biphenyls in Small
Capacitors in Fluorescent Light Ballasts in Schools
and Daycares
OCSPP
2
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Rule title
Program
office
Applicable exclusion
criteria*
Extension of Compliance Date forTSCA Reporting of
Chemical Substances When Manufactured or
Processed as Nanoscale Materials
OCSPP
3
Pesticides; Agricultural Worker Protection Standard;
Reconsideration of Several Requirements
OCSPP
2
Water Resources Reform Development Act Farm
Amendments to the Spill Prevention Control and
Countermeasures Rule
OLEM
1
Effluent Limitations Guidelines and Standards for the
Construction and Development Point Source
Category; Correcting Amendment
OW
3
Source: OIG analysis.
*Applicable exclusion criteria:
1. The only milestone that occurred before January 22, 2020, was tiering and a workgroup may or may not have
been formed.
2. The rulemaking was withdrawn or canceled from the regulatory agenda before ANPRM (if applicable) or being
published in the Federal Register during NPRM.
3. The rulemaking was a minor wording change or extension of effective date.
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Appendix E
Agency Response to Draft Report
SJ^ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
0-
" " OFFICE OF POLICY
mzj
PRO"54
MEMORANDUM
SUBJECT: Response to the Office of Inspector General Draft Report, Proj ect
No. OA&EFY20-0067, "EPA Does Not Always Adhere to Its
Established Action Development Process, " dated February 1, 2021
FROM: Vicki Arroyo, Associate Administrator
Office of Policy
Arroyo, Victoria
TO: Patrick Gilbride, Director
Environmental Research Programs Directorate
Office of Audit and Evaluation
Digitally signed by Arroyo, Victoria
Date: 2021.03.02 17:33:42 -05'00'
Thank you for the opportunity to respond to the issues and recommendations in
the subject draft audit report. Following is a summary of the U.S. Environmental
Protection Agency's overall response, along with its position on each of the
report's recommendations. We have provided high-level corrective actions and
estimated completion dates.
AGENCY'S OVERALL RESPONSE
The events and issues outlined in the draft report occurred over the past several
years, before the arrival of the new senior leadership at EPA. My colleagues and I
support the purpose and goals of EPA's internal Action Development Process
(ADP), particularly that EPA's regulatory actions should be developed with input
from across the agency and based on sound policy, analytical, and scientific
foundations. Many people from the incoming senior leadership team, including
those joining the Administrator's Office and major program offices, have already
been briefed on the ADP and the important role it plays.
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The IG's report identifies some concerning examples of process deviations,
including conclusory determinations by political leadership in the last
Administration that preempted robust engagement through the ADP process. New
leadership at EPA understands the importance of adhering to the ADP process to
inform development of sound policy and is committed to correcting any
deficiencies that occurred in the past.
While we agree that process improvements can be made and we are generally
supportive of the recommendations in the draft report, we have some concerns
about the report's methodology and content. For example, the ADP Guidance is
an internal guidance document that outlines the expected process for developing
EPA regulatory actions. These internal guidelines, however, are not the same as
mandatory requirements, and the ADP was never intended to result in a rigid
checklist to determine "adherence." In fact, the guidance itself sets out
expectations for an internal process that is deliberately designed to be flexible and
accommodate many of the needs and contingencies of regulatory action
development.
The draft report presents ADP Tracker as a records management system.
However, ADP
Tracker was never designed to be one, it is not used as one, and it is not
designated as one by EPA's Records Center. In fact, under the retention schedule
that applies to ADP Tracker, entries in the system are disposable and can be
deleted when no longer needed for business purposes.
This is important context for the nature and type of information stored in ADP
Tracker. Similarly, ADP Tracker is not designed or intended to include or
preserve information regarding substantive decisions related to rulemaking.
Those decisions, and any analysis and justification for them, are properly stored in
official recordkeeping systems and in the official docket for the rule. Finally, the
information in ADP Tracker is generally internal, deliberative, and predecisional,
making it distinct from information contained in the public docket that would
facilitate public participation in rulemaking. The absence of specific
documentation in ADP Tracker related to individual internal rule development
steps is not a sign of agency recordkeeping shortcomings and does not speak to
the adequacy of the substantive record for an individual rule.
Further, EPA has some concerns regarding methodological issues in the draft
report. It is not possible, for instance, to verify that adherence values for
individual rules, as defined in the report, are correct. It is also not clear exactly
what criteria would lead to a designation of adherence, nonadherence, or
undetermined for a specific rule milestone, or what level of documentation would
be sufficient to show adherence. This is important for understanding the report
because it appears that if a rule development meeting happened as expected, but
some paperwork related to the meeting is not contained in ADP Tracker, that
would be deemed as not "adhering" to the ADP. Finally, it should be noted that
EPA, with OIG agreement, did not conduct an exhaustive search for requested
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documentation or records, for example, in the case where the originator of the
information is no longer at the Agency. Even if it were determined, by some
established criteria, that documentation for an internal procedural meeting was
insufficient, that would not support more sweeping statements in the draft report
regarding possible adverse effects on litigation and enforcement, the compromise
of e-government transactions, or the impairment of program operations.
The report makes assertions about the level of adherence for different rule types.
But with the uncertainty in how adherence was defined and applied, the amount of
undetermined adherence, and in many cases the small number of rules in different
subcategories, it is likely that apparent differences in the level of adherence for
different rule types are not meaningful, and certainly are not indicative of any
larger set of EPA rules. This issue should be corrected or at least acknowledged,
since it impacts much of the content and analysis in the draft report.
While current EPA leadership will strive to use the ADP as designed and
acknowledges that doing so has many advantages, the formal meetings outlined in
the ADP are not the sole way that policy direction can be conveyed by the senior
leadership of the agency. One of the goals of the ADP is to ensure the senior
leadership of the agency can provide direction at key moments during rule
development. However, it is also within the Administrator's discretion to provide
rule development instructions outside of the usual ADP framework when
necessary. External events, such as the vacatur of a rule, can result in very
explicit policy direction. In these and other circumstances, policy level direction
has been provided or predetermined and it would be duplicative and unnecessary
to then hold the corresponding ADP milestone meeting. Although these relatively
rare circumstances are not discussed in the current ADP Guidance, portraying the
lack of a particular milestone meeting as inherently inappropriate is misleading,
and implies that the Administrator is precluded from offering direction outside the
confines of a few formal meetings described in internal guidance.
The draft report also implies that some waivers, which are explicitly allowed
under the ADP, were somehow inappropriately granted because the waiver
requests occurred after a previous Administrator stated in a memo that he did not
intend to waive milestones for certain rules. This is an inappropriately rigid
reading of the memo, as it only speaks to intent. In fact, the same memo
reiterates, consistent with the ADP Guidance, that any waivers require the
approval of the Office of Policy Associate Administrator. While the OIG draft
report directly quotes this prior Administrator memo, this crucial context, which is
in the very next sentence of the memo being quoted, is omitted from the draft
report. As we contemplate having the new Administrator affirm the ADP and
express his intent to follow it to the maximum extent possible, such a memo
should not preclude the agency from using the flexibilities already included in the
ADP.
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Thank you for reviewing the Action Development Process. We agree that the
process serves as a strong foundation for developing actions that protect human
health and the environment and fully support its use across the Agency.
AGENCY'S RESPONSE TO DRAFT A UDIT RECOMMENDATIONS
No.
Recommendation
High-Level Corrective
Action(s)
Est. Completion
Date
1
On an annual basis, reinforce the EPA
administrator's expectation that the Action
Development Process will be followed for
all regulatory actions, including procedures
to waive milestones for Tier 1 and Tier 2
actions.
The incoming EPA Administrator or
other senior political official will issue a
memo affirming the importance of the
Action Development Process.
Q3, FY21
2
Query key internal rulemaking
stakeholders, such as the Regulatory
Steering Committee, workgroup chairs, and
Office of Policy staff, on the use of the
moot designation and determine whether
the designation is necessary and
appropriate. If a decision is made to use the
moot designation, define moot, clarify its
applicability, and institute documentation
requirements for using the moot designation
in the Action Development Process.
Office of Policy staff will discuss
internally and with the Regulatory
Steering Committee the use of the moot
designation to clarify its current use and
inform a decision as to whether it or
some other designation should be
formally incorporated into the ADP
Guidance.
Q3, FY21
3
Define for program offices the key
regulatory decisions and information that
offices are expected to include in the Action
Development Process tracking database.
The Office of Policy will provide
information to the Regulatory Steering
Committee that clarifies the appropriate
information to be entered into EAMS as
part of the transition from ADP Tracker.
Q4, FY 2021
4
In coordination with program offices,
develop a plan to improve oversight of the
Action Development Process tracking
database that includes periodic assessments
or system checks to verily that the database
includes identified key regulatory decisions
and information.
The Office of Policy will initiate a
discussion with the Regulatory Steering
Committee about the development of
such a plan.
Q3, FY2021
5
Query EPA staff, through Regulatory
Steering Committee representatives, on the
adequacy of existing Action Development
Process training and revise training methods
and reallocate resources for training as
needed.
The Office of Policy surveyed the
Regulatory Steering Committee in
October 2020 about training needs and is
adjusting future ADP training to be
responsive to the input received.
Q2, FY2021
CONTACT INFORMATION
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If you have any questions regarding this response, please contact the Office of the
Administrator's Audit Follow-up Coordinator, Michael Benton, at
benton.michael@epa.gov or 202-564-2860.
Attachment
cc: William Nickerson, Office of Policy
Erin Barnes-Weaver, Program Manager, OIG
Andrew LeBlanc, Agency OIGFollow-Up Coordinator, Office of the Comptroller
Michael Benton, Audit Follow-Up Coordinator, Office of the Administrator
Marc Vincent, Audit Follow-Up Coordinator, Office of Air and Radiation
Janet Weiner, Audit Follow-Up Coordinator, Office of Chemical Safety and Pollution
Prevention Gwendolyn Spriggs, Audit Follow-Up Coordinator, Office of Enforcement
and Compliance Assurance
Shanquenetta Anderson, Audit Follow-Up Coordinator, Office of General Counsel
Lenore Connell, Audit Follow-Up Coordinator, Office of International and Tribal
Affairs
Kecia Thornton, Audit Follow-Up Coordinator, Office of Land and Emergency
Management
Kelly van Bronkhorst, Audit Follow-Up Coordinator, Office of Research and
Development
Tiffany Crawford, Audit Follow-Up Coordinator, Office of Water
Regional Audit Follow-Up Coordinators, Regions 1-10
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Distribution
Appendix F
The Administrator
Associate Deputy Administrator
Assistant Deputy Administrator
Chief of Staff
Deputy Chief of Staff
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Associate Administrator for Policy, Office of the Administrator
Director, Office of Continuous Improvement, Office of the Chief Financial Officer
Audit Follow-Up Coordinator, Office of the Administrator
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