* n \
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Report Contributors: Sarah Davidson
Jeffrey Harris
Natasha Henry
Chad Kincheloe
Barry Parker
Abbreviations
EPA U.S. Environmental Protection Agency
OCSPP Office of Chemical Safety and Pollution Prevention
OECA Office of Enforcement and Compliance Assurance
OIG Office of Inspector General
TSCA Toxic Substances Control Act
Cover Image: Examples of GenX chemicals uses. (EPA OIG graphic)
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Learn more about our OIG Hotline.
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www.epa.gov/oiq
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tffcD ST/ff.
• U.S. Environmental Protection Agency 20-E-0177
^ \ Dffirp nf Insnprtnr ^pnpral May 28, 2020
• UiOi 11 I V 11 Ul 11 I ICr I I Id I I I UICUII
¦ — - \ Office of Inspector General
® I
At a Glance
r-<
^ PRO"**-
Why We Did This Project
The U.S. Environmental
Protection Agency's Office of
Inspector General conducted
this evaluation to determine
what actions the EPA took to
verify compliance with the
requirements of the 2009 Toxic
Substances Control Act
Premanufacture Notice
Consent Order with DuPont
(responsibilities transferred to
The Chemours Company in
2015) to prevent the release of
GenX chemicals in the Cape
Fear River in North Carolina.
GenX chemicals are a type of
per- and polyfluoroalkyl
substances, known as PFAS,
found in surface water,
groundwater, drinking water,
rain water, and air emissions.
There is toxicological evidence
that some PFAS chemicals
have adverse developmental
and immunological effects in
animals and humans.
This report addresses the
following:
• Ensuring the safety of
chemicals.
EPA Toxic Substances Control Act Consent
Orders Need Better Coordination
What We Found
We found insufficient communication and
coordination between the two EPA offices
responsible for developing and enforcing
the consent order requirements designed
to reduce risks in the manufacture of
GenX chemicals.
Regions need to be aware of the
TSCA Section 5(e) Consent Orders
in their region, and the Office of
Enforcement and Compliance
Assurance should approve, in
advance, the terms and conditions
of each consent order.
In 2008, the EPA received premanufacture notices from DuPont to manufacture
two new GenX chemicals. In 2009, the Office of Chemical Safety and Pollution
Prevention issued the company a TSCA Premanufacture Notice Consent Order
with terms and conditions related to the manufacturing of the chemicals. The
Consent Order required the company to determine how to recover and capture
99 percent of GenX's manufacturing discharges and air emissions. However, the
Consent Order was not reviewed or approved by the Office of Enforcement and
Compliance Assurance, which is responsible for conducting inspections to verify
compliance. Until June 2017, the EPA's actions to verify compliance with the
2009 Consent Order and new chemicals testing requirements consisted of
tracking and reviewing information provided by the manufacturer.
Following the local media coverage of the presence of GenX chemicals in the
Cape Fear River in 2017, Region 4 and EPA contractors conducted the EPA's
first on-site compliance monitoring inspection at the Fayetteville Works facility,
which manufactures GenX. We found that the Region 4 inspectors were unaware
of the 2009 Consent Order and its requirements until the inspection was
requested by EPA headquarters.
Recommendations and Planned Agency Corrective Actions
We recommend that the EPA establish and implement processes:
1. For the Office of Enforcement and Compliance Assurance to review and
approve the terms and conditions of TSCA Section 5(e) Consent Orders
that it is responsible for verifying during compliance monitoring and
enforcement activities.
Address inquiries to our public
affairs office at (202) 566-2391 or
PIG WEBCQMMENTS@epa.gov.
List of PIG reports.
2. To provide final TSCA Section 5(e) Consent Orders to regions and verify
that the regions have the final consent orders.
The EPA did not provide an acceptable corrective action for Recommendation 1,
and we consider this recommendation unresolved. For Recommendation 2, the
Agency provided an alternative course of action that we find acceptable. We
consider Recommendation 2 resolved with corrective action pending.
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^EDSX
¦? A \
I S UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Vl'r Q* WASHINGTON, D.C. 20460
"41 PRO^
THE INSPECTOR GENERAL
May 28, 2020
MEMORANDUM
SUBJECT: EPA Toxic Substances Control Act Consent Orders Need Better Coordination
Report No. 20-E-0177
FROM: Sean W. O'Donnell
TO: Alexandra Dapolito Dunn, Assistant Administrator
Office of Chemical Safety and Pollution Prevention
This is our report on the subject evaluation conducted by the Office of Inspector General of the
U.S. Environmental Protection Agency. The project number for this evaluation is OA&E-FY19-0348. 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 evaluation resolution procedures.
The Office of Chemical Safety and Pollution Prevention is responsible for the issues discussed in this
report.
We made two recommendations in this report. In accordance with EPA Manual 2750, your Office
provided an acceptable corrective action and estimated milestone date for Recommendation 2. This
recommendation is resolved, and no final response is necessary
Action Required
For Recommendation 1, your Office did not provide an acceptable corrective action and estimated
milestone date. Therefore, Recommendation 1 is unresolved. In accordance with EPA Manual 2750, the
resolution process begins immediately with the issuance of this report. We are requesting a meeting within
30 days between the assistant administrator for Chemical Safety and Pollution Prevention and the OIG's
assistant inspector general for Audit and Evaluation. If resolution is still not reached, the Office of
Chemical Safety and Pollution Prevention is required to complete and submit a dispute resolution request
to the chief financial officer.
We will post this report to our website at www.epa.gov/oig.
-------
EPA Toxic Substances Control Act Consent
Orders Need Better Coordination
20-E-0177
Table of C
Purpose 1
Background 1
Scope and Methodology 4
Results 5
EPA Actions to Confirm Consent Order Compliance 5
Requirements of 2009 Consent Order 6
Conclusions 7
Recommendations 7
Agency Response and OIG Assessment 7
Status of Recommendations and Potential Monetary Benefits 9
Appendices
A Agency Comments on Draft Report 10
B Supplemental Comments on Draft Report 14
C Distribution 17
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Purpose
The U.S. Environmental Protection Agency's Office of Inspector General
conducted this evaluation to determine what actions the EPA took to verify
compliance with the requirements of the 2009 Toxic Substances Control Act
Premanufacture Notice Consent Order with DuPont to prevent the release of
GenX chemicals in the Cape Fear River basin, located in North Carolina. In 2015,
DuPont's manufacturing rights and interest for the chemicals subject to the
Consent Order were transferred to The Chemours Company.
We limited our review to the EPA's actions related to the 2009 TSCA Consent
Order with DuPont, now Chemours. Other authorities that are not covered in this
review also address impacts of the Cape Fear River GenX contamination. For
example, in 2019, the North Carolina Department of Environmental Quality
signed a consent order with Chemours and other parties regarding chemical
contamination, including GenX releases in the Cape Fear region. This North
Carolina order requires Chemours to address all sources of per- and
polyfluoroalkyl substances, known as PFAS, at the Fayetteville Works facility, a
chemical plant located adjacent to the Cape Fear River. North Carolina's order is
designed to prevent further impacts to air, soil, groundwater, and surface waters
and is intended to provide relief to people around the facility and communities
downstream.
Background
EPA New Chemical Program Regulation of GenX
Under TSCA, the EPA is responsible for assessing and managing risks to human
health and the environment before a new chemical substance is introduced into
commerce. Section 5 of TSCA requires a premanufacture notice to be provided to
the EPA before a new chemical substance for a nonexempt commercial purpose is
manufactured in or imported to the United States.
The Office of Chemical Safety and Pollution Prevention reviews premanufacture
notices to identify any risks that the new substance could pose to human health
and the environment and develops TSCA Section 5(e) Consent Orders to address
risks, if necessary. As shown in Figure 1, the Office of Enforcement and
Compliance Assurance at EPA headquarters and the Enforcement and
Compliance Assurance Divisions in the EPA regions conduct inspections to verify
compliance with the consent orders.
20-E-0177
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Figure 1: EPA Section 5(e) Consent Order roles and responsibilities for the
Fayetteville Works facility
OCSPP
- Negotiates consent
order with the
company.
- Reviews company
protocols for quality
assurance and testing
results.
Source: OIG analysis.
In 2008, the EPA received premanufacture
notices from DuPont for two chemical substances
that are used to manufacture GenX chemicals.
GenX chemicals, which are a type of PFAS, are
used in many applications because of their unique
physical properties such as resistance to high and
low temperatures, resistance to degradation, and
nonstick properties. PFAS chemicals have been
used in the United States since the 1940s and are
found in many consumer products such as paints, food packaging, and stain
repellants.
The EPA's review of DuPont's GenX premanufacture notices found the
following:
• The information available to the Agency was insufficient to permit a
reasoned evaluation of the health and environmental effects of the
chemicals.
• The uncontrolled manufacture, import, processing, distribution in
commerce, use, and disposal of the chemicals may present an
unreasonable risk to health or the environment.
• The chemical substances will be produced in substantial quantities and
will likely enter the environment in substantial quantities, and there may
be significant or substantial human exposure to the substance.
These findings constituted the basis for the TSCA Section 5(e) Consent Order
with DuPont.
OECA
Region 4
- Conducts
compliance
monitoring and
enforcement
activities.
- Conducts
inspections.
GenX chemicals have been
found in surface water,
groundwater, drinking water,
rain water, and air emissions.
There is toxicological
evidence that some PFAS
have adverse developmental
and immunological effects in
animals and humans.
20-E-0177
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In 2009, the EPA and DuPont signed a TSCA
Section 5(e) Consent Order, which stipulated
terms and conditions for DuPont to manufacture
premanufacture notice substances in the United
States, including in Dupont's Fayetteville
Works facility. The 2009 Consent Order
provided requirements to recover and capture
(destroy) or recycle premanufacture notice
substances from all effluent process streams and
air emissions at an overall efficiency of
99 percent, allowing for up to 1 percent of the
discharges and emissions generated from the
manufacturing, processing, distributing in commerce, using, and disposing of the
substances to be released into the air and water. According to OCSPP staff, it was
up to the company to determine how to achieve compliance with this requirement.
The Consent Order also controlled worker exposure by requiring the use of
personal protective equipment, such as respiratory and skin protection, and testing
for human health or environmental effects from exposure to the premanufacture
notice substance. Testing protocols and results were to be sent to the EPA.
GenX Released into the Cape Fear River
In June 2017, local media in North Carolina reported the presence of GenX
chemicals in the Cape Fear River. In July 2017, the governor of North Carolina
sent a letter to the EPA concerning chemical releases into the Cape Fear River.
The letter identified the GenX discharge as problematic since the chemicals are
unregulated and do not have an established maximum contaminant level. The
letter stated that the EPA bears sole responsibility for regulating the introduction
of new chemicals and asked the Agency to review the 2009 Consent Order.
Chemours' Fayetteville Works Facility
The North Carolina Department of Environmental Quality is the lead stewardship
agency for the protection of the state's environmental resources. According to its
website, the Chemours Fayetteville Works facility has historically discharged
water in the Cape Fear River and has operated various sources of air emissions
and air pollution control technology pursuant to an air quality permit.
Under certain circumstances,
EPA can use a TSCA Section
5(e) Consent Order to place
restrictions on the
manufacturing of a new
chemical pending development
of test data. The order allows
the manufacturing of the new
chemical be subject to
restrictions on processing
methods, production volume,
or use that reduce or limit risks
to human health or the
environment.
20-E-0177
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Figure 2: Map of Fayetteville Works facility
Chemours Fayetteville Works facility.
VIRGINIA
NORTH
CAROLINA
SOUTH
CAROLINA
GEORGIA
Source: The EPA OIG.
Scope and Methodology
We conducted this evaluation from October 2019 through January 2020 in
accordance with the Quality Standards for Inspection and Evaluation published in
January 2012 by the Council of the Inspectors General on Integrity and
Efficiency. Those standards require that we plan and perform the evaluation to
obtain sufficient, appropriate evidence to provide a reasonable basis for our
findings, conclusions, and recommendations based on our evaluation objective.
We believe that the evidence obtained provides a reasonable basis for our
findings, conclusions, and recommendations based on our evaluation objective.
To understand the Agency's oversight of the 2009 Consent Order, some of the
documents we reviewed include:
• OECA and OCSPP National Program Guidances.
• OECA Compliance Monitoring Strategy.
• The 2009 TSCA Section 5(e) Consent Order, with confidential business
information redacted.
• Inspection reports, with confidential business information redacted.
• February 2019 Notice of Violation to Chemours.
We interviewed staff from the OCSPP, OECA, and Region 4. We also reviewed
information and documentation from the North Carolina Department of
Environmental Quality website.
20-E-0177
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Results
Until June 2017, the EPA's actions to verify compliance with the 2009 Consent
Order and new chemicals testing requirements consisted of tracking and
reviewing information provided by Chemours. Following the local media
coverage of the presence of GenX chemicals in the Cape Fear River, Region 4
and EPA contractors conducted the Agency's first on-site TSCA compliance
monitoring inspection at the Fayetteville Works facility in June 2017. Region 4
was unaware of the 2009 Consent Order and its requirements until the inspection
was requested by EPA headquarters. We found that insufficient communication
and coordination between OECA, the OCSPP, and Region 4 hampered the
Agency's ability to monitor and determine compliance with the 2009 Consent
Order requirements.
EPA Actions to Confirm Consent Order Compliance
EPA Tracked Consent Order Testing Requirements
For this 2009 Consent Order, the OCSPP tracked and reviewed information
provided by Chemours regarding compliance with the testing requirements.
According to an OCSPP manager, a program manager is assigned to each
TSCA Section 5(e) Consent Order and is largely responsible for
communicating with the premanufacture notice submitter and verifying
compliance with any testing requirements included in the order. According to
OCSPP personnel, there were no known issues with Chemours performing the
Consent Order's testing requirements. The OCSPP provided the OIG with a
spreadsheet documenting Chemours' compliance with the testing
requirements. An EPA review of these data was the extent of enforcement and
compliance oversight of the Consent Order until 2017.
EPA First Inspected for TSCA Compliance in June 2017
EPA headquarters requested that Region 4 conduct an on-site TSCA
compliance monitoring inspection at the Fayetteville Works facility after local
media reported the presence of GenX chemicals in the Cape Fear River.
Region 4 and EPA contractors conducted the Agency's first on-site TSCA
compliance monitoring inspection at the Fayetteville Works facility on
June 28 and 29, 2017. Region 4 personnel informed us that they do not know
all the headquarters-negotiated consent orders within their Region. In fact,
they did not know about the 2009 Consent Order with Chemours until the
inspection was requested. Upon request, OECA supplied the 2009 Consent
Order to Region 4 in June 2017.
We asked OCSPP staff for an Agency policy or procedure for disseminating
final consent orders to applicable regions. The OCSPP provided a September
2019 transmittal document that describes a process in which EPA contractors
20-E-0177
5
-------
develop a memorandum to send to the applicable region, notifying it of a
consent order. The OCSPP could not identify an EPA policy that contained
defined roles and responsibilities, such as how the contractor receives the
information to develop the memorandum and how the EPA knows the regions
and OECA received the consent orders. The OCSPP needs written policies
and procedures to verify that applicable regions receive final consent orders so
that the regions are aware and knowledgeable of TSCA activities to assist in
prioritizing inspections.
Results of TSCA Inspection
On April 24, 2018, Region 4 issued a report on the results of the Fayetteville
Works TSCA compliance inspection, which included a review of the
2009 Consent Order. On February 13, 2019, OECA's Office of Civil
Enforcement sent a TSCA Notice of Violation to Chemours, which was
applicable to two facilities using the GenX manufacturing process: the
Fayetteville Works facility and the Washington Works facility in West
Virginia. The Notice of Violation did not include any violations of the
2009 Consent Order at the Fayetteville Works facility.
According to the Notice of Violation, "The EPA continues to investigate and
review information concerning the compliance status of these and other
Chemours facilities relating to TSCA. ... The EPA may find additional TSCA
violations as the investigations continues."
Requirements of 2009 Consent Order
As shown in Figure 3, the 2009 Consent Order required the GenX chemical
manufacturing process operations to "recover and capture (destroy) or recycle the
[premanufacture notice] substances at an overall
efficiency of 99% from all the effluent process
streams and the air emissions (point source and
fugitive)"
According to OCSPP personnel, the 99 percent
removal efficiency requirement was a stringent but
"achievable" level and recognized that a 100 percent
removal efficiency requirement was not achievable
when negotiating the terms of the 2009 Consent
Order with the manufacturer. They also stated that
consent orders commonly either require no
emissions or discharges of certain substances or set a
numerical limit for emissions or discharges of certain
substances rather than a percentage requirement.
OCSPP staff added that it was up to the company to
determine how to achieve compliance with this
requirement. OECA, which is responsible for on-site
Figure 3: Consent Order requirement
99%
Premanufacture
notice substances
removal efficiency
required for
compliance
Source: The EPA OIG.
20-E-0177
6
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compliance inspections for this requirement, was not consulted when the
requirement was established.
We believe that OECA should review and approve, in advance, the TSCA
Section 5(e) Consent Order compliance monitoring and enforcement requirements
for which it is responsible.
Conclusions
While the EPA has taken steps to verify compliance with the 2009 TSCA Consent
Order, improved communication between OECA, the OCSSP, and Region 4
would help the Agency to better determine compliance with its requirements.
Region 4 did not receive a copy of the Consent Order when it was signed in 2009
and had to request it prior to conducting an inspection in 2017. The OCSPP
should implement procedures to improve coordination between the offices and
assist the EPA in determining compliance with this Consent Order.
Recommendations
We recommend that the assistant administrator for Chemical Safety and Pollution
Prevention:
1. Implement a process so that the Office of Enforcement and Compliance
Assurance reviews and approves the Toxic Substances Control Act
Section 5(e) Consent Orders terms and conditions that it will be
responsible for verifying during compliance monitoring and enforcement
activities.
2. Implement a process to provide final Toxic Substances Control Act
Section 5(e) Consent Orders to regions with facilities subject to the terms
and conditions of the Consent Orders in an appropriate time frame, and
verify that EPA regions acknowledge receipt of the final Toxic Substances
Control Act Section 5(e) Consent Orders.
Agency Response and OIG Assessment
The Agency provided a response to our draft report on April 17, 2020
(Appendix A). The EPA's proposed corrective action for Recommendation 1—to
memorialize a protocol for OECA engagement during the development of TSCA
Section 5(e) Consent Orders—did not meet the intent of this recommendation
because the response did not explicitly state that OECA would agree or concur
with the conditions of the consent orders that it would be responsible for ensuring
compliance and enforcing. On April 28, 2020, the Agency provided a revised
response (Appendix B), which included a statement that the proposed protocol
will provide a consultation role for OECA on the conditions of future Section 5(e)
Consent Orders. The OIG concluded that the proposed corrective action does not
20-E-0177
7
-------
meet the intent of this recommendation because the response does not explicitly
state that OECA would approve the compliance monitoring and enforcement
requirements of the consent order.
The EPA's proposed corrective action for Recommendation 2 provides an
alternative course of action that meets the intent of this recommendation. The
OIG recommended that regions be directly notified of new consent decrees within
their jurisdictions. The Agency has identified a corrective action that will provide
a searchable database of TSCA Section 5(e) Consent Orders that will enable
regions to focus on compliance monitoring and enforcement activities they
perform per OECA's National Program Guidance for fiscal years 2020-2021. The
search tool is expected to be completed by December 31, 2020. The OIG
considers Recommendation 2 resolved with the corrective action pending.
The Agency provided specific suggestions for our consideration, and we made
revisions to the report as appropriate.
20-E-0177
8
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Rec.
No.
Page
No.
Subject
Status1
Action Official
Planned
Completion
Date
Potential
Monetary
Benefits
(in $000s)
1
7
Implement a process so that the Office of Enforcement and
Compliance Assurance reviews and approves the Toxic
Substances Control Act Section 5(e) Consent Orders terms and
conditions that it will be responsible for verifying during
compliance monitoring and enforcement activities.
U
Assistant Administrator for
Chemical Safety and
Pollution Prevention
2
7
Implement a process to provide final Toxic Substances Control
Act Section 5(e) Consent Orders to regions with facilities subject
to the terms and conditions of the Consent Orders in an
appropriate time frame, and verify that EPA regions
acknowledge receipt of the final Toxic Substances Control Act
Section 5(e) Consent Orders.
R
Assistant Administrator for
Chemical Safety and
Pollution Prevention
12/31/20
1 C = Corrective action completed.
R = Recommendation resolved with corrective action pending.
U = Recommendation unresolved with resolution efforts in progress.
20-E-0177
9
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Appendix A
Agency Comments on Draft Report
% UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\ 72 I WASHINGTON, D.C. 20460
\s. .c/
April 17, 2020
MEMORANDUM
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
SUBJECT:
FROM:
TO:
Response to Draft Report for Project Number OA&E-FY19-0348
Alexandra Dapolito Dunn
Assistant Administrator
Sean W. O'Donnell
Inspector General
ALEXANDRA Digitally signed by ALEXANDRA
DAPOLITO DUNN
DAPOLITO DUNN Date: 2020.04.17 21:34:07 -04'00'
This memorandum responds to the OIG's Draft Report entitled "EPA Toxic Substances Control
Act Consent Orders Need Better Coordination," dated April 8, 2020.
I. General Comments:
The Office of Chemical Safety and Pollution Prevention (OCSPP) appreciates the OIG's effort in
evaluating EPA's actions to verify compliance with the requirements of the Agency's 2009 Toxic
Substances Control Act Premanufacture Notice Consent Order with DuPont/Chemours. That consent
order required certain actions by the company to prevent the release of GenX chemicals, which are a
type of PFAS, into the Cape Fear River in North Carolina.
The Office of Enforcement and Compliance Assurance (OECA) and OCSPP have reviewed the
Draft Report and generally agree to the recommendations. Consequently, this response includes a
discussion of our actions to implement those recommendations, which in our view are sufficient
to declare the recommendations to be completed and resolved at the issuance of the Final Report.
We also discuss below our specific concerns with the Report's characterization of the Agency's
regulatory actions with respect to PFAS. Separately, we are conveying to your office the
Agency's Technical Comments, which we respectfully request remain internal to EPA.
20-E-0177
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II.
The Report Mischaracterizes Existing and Ongoing PFAS Regulatory Actions:
The Draft Report states that there are "no federal regulatory guidelines for PFAS." This
statement is significantly erroneous; there are numerous regulatory actions that have been taken
involving PFAS under TSCA, as well as other Agency actions related to PFAS.
First, the review of new chemical submissions puts in place restrictions as necessary to ensure no
unreasonable risk, using Section 5 Consent Orders and Significant New Use Rules (SNURs),
which constitute regulatory actions. Second, OPPT has promulgated SNURs for hundreds of
PFAS that are existing chemicals under TSCA. For a list of existing chemical SNURs
promulgated under TSCA, see the webpage: Risk Management for Per- and Polyfluoroalkyl
Substances (PFAS) under TSCA.1
Furthermore, PFAS actions are a top EPA priority, and EPA has made significant progress in
implementing its PFAS Action Plan.2 The PFAS Action Plan demonstrates the agency's critical
national leadership by providing both short-term solutions and long-term strategies to address
this important issue. The Action Plan provides a multi-media, multi-program, national research,
and risk communication plan to address this emerging environmental challenge.
OPPT has several actions tracked in the Action Plan including the addition of PFAS to the
Toxics Release Inventory (TRI) and the finalization of the Long Chain PFAS Significant New
Use Rule. The FY 2020 National Defense Authorization Act (NDAA) added certain PFAS
chemicals to the TRI effective on January 1, 2020 and set up a process for reviewing and
potentially adding others. In 2015, EPA proposed a TSCA SNUR to require manufacturers,
importers and processors of PFOA and PFOA-related chemicals to submit a notice to EPA
before starting or resuming new uses of these chemicals in any products. On March 3, 2020,
EPA issued a supplemental proposal for this rule. This rule would give EPA the opportunity to
evaluate these uses and, where necessary, take action to prohibit or limit the activity before it
occurs. The NDAA requires EPA to finalize the PFAS SNUR by June 22, 2020.
An inventory of other EPA regulatory and management actions completed or underway by other
EPA Offices are outlined in the Agency's PFAS Action Plan.
OIG RESPONSE: The OIG statement was intended to address the lack of PFAS maximum
contaminant levels in drinking water and listing PFAS as hazardous substances, enabling the
EPA to use the Comprehensive Environmental Response, Compensation, and Liability Act for
cleanup orders and cost recovery, as identified in the EPA's February 2019 PFAS Action Plan.
We realize that this is under the heading of the EPA's New Chemical Program Regulation,
which might confuse the reader. As such, we deleted the sentence from the final report.
1 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-and-polYfluoroalkvl-
substances-pfas
2 https://www.epa.gov/pfas/epas-pfas-action-plan
20-E-0177
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III. Response to the Recommendations:
Recommendation 1: "Implement a process so that the Office of Enforcement and Compliance
Assurance reviews and approves the Toxic Substances Control Act 5(e) Consent Orders terms
and conditions that the Office will be responsible for verifying during compliance monitoring
and enforcement activities."
Recommendation 2: "Implement a process to provide final Toxic Substances Control Act 5(e)
Consent Orders to regions with facilities subject to the terms and conditions of the consent order
in an appropriate time frame and verify that EPA regions acknowledge receipt of the final Toxic
Substances Control Act 5(e) Consent Orders."
Corrective Actions Underway and Completed: OECA and OCSPP have already enhanced
coordination and developed new tools to assist with compliance monitoring activities by OECA
and the Regions. These efforts include:
• Enhanced tracking of TSCA section 5(e) orders and elevation of PFAS chemicals as an
enforcement focus area for TSCA section 5 compliance monitoring activities: OECA has
already implemented an internal protocol for tracking TSCA section 5(e) orders received
from OCSPP, which includes reviewing and capturing specific information from each
order in an internal database broadly covering substances regulated under TSCA section
5. OECA has populated the database with Regional and facility-specific information and
shared it with the Regions via OPPT's Confidential Business Information (CBI) LAN,
accessible through the Virtual Desktop Infrastructure (VDI). OECA and the Regions can
consider this information as part of a consolidated Core TSCA targeting and compliance
monitoring approach (see Compliance Monitoring Strategy for TSCA).3 OECA issues
regular enforcement program guidance that focuses on specified national compliance
monitoring activities and priorities. OECA identified PFAS chemicals as a priority area
for TSCA section 5 compliance monitoring activities in OECA's National Program
Guidance for fiscal years 2020-2021.4
• Developing new chemical database search functionality: Since implementing the Virtual
Desktop Infrastructure in 2016, OCSPP, OECA and Regional users can remotely access
the Chemical Information System (CIS) and search for TSCA section 5(e) orders by
company or chemical. To improve geographic and facility-based queries of substances
regulated under TSCA section 5, OECA and OPPT are developing a dynamic search tool
that will enable OECA and Regional users to have full access to documents that are part
of the TSCA section 5 chemical review and regulatory process. This search tool will
extract information from a variety of chemical databases housed on the OPPT LAN,
including chemical risk and facility location information. The search tool is expected to
be completed by the end of calendar year 2020.
• Developing a new model TSCA section 5(e) order and protocol for OECA input in the
development of orders: OECA and OCSPP have collaborated on an updated model TSCA
3 https://www.epa.gov/sites/production/files/2014-01/documents/tsca-cms.pdf
4 https://www.epa.gov/sites/production/files/2019-06/documents/fV-20-21-oeca-np-guidance.pdf
20-E-0177
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section 5(e) Order. The offices worked together in 2019 to strengthen and clarify the
model document that will serve as the baseline in negotiations between EPA and
companies with regard to the new chemical substance submissions. Discussions are
underway between offices to memorialize a protocol for OECA engagement during the
development of TSCA section 5(e) orders. The protocol is expected to be completed by
the end of calendar year 2020.
OIG RESPONSE: The EPA's proposed corrective action for Recommendation 1—to
memorialize a protocol for OECA engagement during the development of TSCA Section 5(e)
Consent Orders—did not meet the intent of this recommendation because the response did not
explicitly state that OECA would agree or concur with the conditions of the consent orders
that it will be responsible for ensuring compliance and enforcing.
The EPA's proposed corrective action for Recommendation 2 provides an alternative course of
action that meets the intent of this recommendation. The OIG recommended that regions be
directly notified of new consent decrees within their jurisdictions. The Agency has identified a
corrective action that will provide a searchable database of TSCA Section 5(e) Consent Orders
that will enable regions to focus on compliance monitoring and enforcement activities they
should perform per OECA's National Program Guidance for fiscal years 2020-2021. The
search tool is expected to be completed by December 31, 2020. The OIG considers
Recommendation 2 resolved with corrective action pending.
cc: All OCSPP DAA/AAAs
Program Office OD, DODs
Jeffrey Harris, OIG
Sarah Davidson, OIG
Natasha Henry, OIG
Chad Kincheloe, OIG
Barry Parker, OIG
Janet L. Weiner, OCSPP Audit Liaison
John Latham, OPPT Program Office Audit Liaison
Susanna Blair, OPPT
Susan Bodine, OECA AA
Larry Starfield, OECA PDAA
Rosemarie Kelley, OECA/OCE
James Miles, OECA/OCE
Gwendolyn Spriggs, OECA Audit Liaison
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Appendix B
Supplemental Comments on Draft Report
£ \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\ ^^7 I WASHINGTON, D.C. 20460
PRCrtfc
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
April 28, 2020
MEMORANDUM
SUBJECT: Clarification on Proposed Corrective Actions in Response to Draft Report for
Project Number OA&E-FY19-0348
FROM: Alexandra Dapolito Dunn ALEXANDRA Digitally signed by ALEXANDRA
Assistant Administrator DAPOLITO DUNN Date2020.04.2819:2335-ww
TO: Sean W. O'Donnell
Inspector General
This memorandum provides additional requested clarification about the Agency's proposed
Corrective Actions to respond to the OIG's Draft Report entitled "EPA Toxic Substances
Control Act Consent Orders Need Better Coordination," dated April 8, 2020.
Amended Response to the Recommendations:
Recommendation 1: "Implement a process so that the Office of Enforcement and Compliance
Assurance reviews and approves the Toxic Substances Control Act 5(e) Consent Orders terms
and conditions that the Office will be responsible for verifying during compliance monitoring
and enforcement activities."
• Development of a new Model TSCA Section 5(e) Order and Protocol for OECA input in
the development of orders: OECA and OCSPP have collaborated on an updated Model
TSCA Section 5(e) Order. In 2019, the offices worked together to strengthen and clarify
the Model Order, which will serve as the baseline for negotiations between EPA and
companies with regard to new chemical substance submissions. In 2020, OCSPP and
OECA are working to memorialize a Protocol for OECA engagement during the
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development of TSCA section 5(e) orders. The Protocol will provide a consultation role
for OECA on the conditions of future TSCA section 5(e) orders. (OCSPP and OECA
expect they will agree on those conditions.) OCSPP will complete the Protocol by
December 31, 2020.
Recommendation 2: "Implement a process to provide final Toxic Substances Control Act 5(e)
Consent Orders to regions with facilities subject to the terms and conditions of the consent order
in an appropriate time frame and verify that EPA regions acknowledge receipt of the final Toxic
Substances Control Act 5(e) Consent Orders."
• OECA has already implemented an internal protocol for tracking TSCA section 5(e)
orders received from OCSPP, which includes reviewing and capturing specific
information from each order in an internal database broadly covering substances
regulated under TSCA section 5. OECA has populated the database with Regional and
facility-specific information and shared it with the Regions via OCSPP/OPPT's
Confidential Business Information (CBI) LAN, accessible through the Virtual Desktop
Infrastructure (VDI). Since implementing the Virtual Desktop Infrastructure in 2016,
OCSPP, OECA and Regional users can remotely access the Chemical Information
System (CIS) and search for TSCA section 5(e) orders by company or chemical. To
improve geographic and facility-based queries of substances regulated under TSCA
section 5, OECA and OCSPP/OPPT are developing a dynamic search tool that will
enable OECA and Regional users to have full access to documents that are part of the
TSCA section 5 chemical review and regulatory process. This search tool will extract
information from a variety of chemical databases housed on the OPPT LAN, including
chemical risk and facility location information.
To enable Regions to focus compliance monitoring and enforcement activities required
by OECA's National Program Guidance for FY2020-2021, the Agency will develop a
searchable database of TSCA 5(e) orders. OCSPP/OPPT will complete the search tool by
December 31, 2020.
OIG RESPONSE: The corrective action in this amended response falls short of meeting the
intent of Recommendation 1. The amended response states, "The Protocol will provide a
consultation role for OECA on the conditions of future TSCA section 5(e) orders. (OCSPP and
OECA expect they will agree on those conditions.)" This language does not provide sufficient
assurance that compliance monitoring and enforcement requirements in future TSCA 5(e)
orders will be agreed to by the OCSPP and OECA. Therefore, the OIG considers this
recommendation unresolved.
cc: All OCSPP DAA/AAAs
Program Office OD, DODs
Jeffrey Harris, OIG
Sarah Davidson, OIG
Natasha Henry, OIG
Chad Kincheloe, OIG
Barry Parker, OIG
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Janet L. Weiner, OCSPP Audit Liaison
John Latham, OPPT Program Office Audit Liaison
Susanna Blair, OPPT
Susan Bodine, OECA AA
Larry Starfield, OECA PDAA
Rosemarie Kelley, OECA/OCE
James Miles, OECA/OCE
Gwendolyn Spriggs, OECA Audit Liaison
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Appendix C
Distribution
The Administrator
Assistant Deputy Administrator
Associate Deputy Administrator
Chief of Staff
Deputy Chief of Staff/Operations
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Assistant Adminstrator for Chemical Safety and Pollution Prevention
Assistant Administrator for Enforcement and Compliance Assurance
Regional Administrator, Region 4
Principal Deputy Assistant Administrator for Chemical Safety and Pollution Prevention
Deputy Assistant Administrator for Chemical Safety and Pollution Prevention
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Director, Office of Continuous Improvement, Office of the Administrator
Principal Deputy Assistant Administrator for Enforcement and Compliance Assurance
Audit Follow-Up Coordinator, Office of the Administrator
Audit Follow-Up Coordinator, Office of Chemical Safety and Pollution Prevention
Audit Follow-Up Coordinator, Office of Enforcement and Compliance Assurance
Audit Follow-Up Coordinator, Region 4
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