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U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Ensuring the safety of chemicals
Compliance with the law
EPA's Chemical Data Reporting
Rule Largely Implemented as
Intended, but Opportunities
for Improvement Exist
Report No. 18-P-0226
July 27, 2018

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Report Contributors:	Ganesa Curley
Jeffrey Harris
Chad Kincheloe
Barry Parker
Abbreviations
CBI
Confidential Business Information
CCD
Chemical Control Division
CDR
Chemical Data Reporting
EPA
U.S. Environmental Protection Agency
HQ
Headquarters
IUR
Inventory Update Rule
OECA
Office of Enforcement and Compliance Assurance
OIG
Office of Inspector General
OPPT
Office of Pollution Prevention and Toxics
TSCA
Toxic Substances Control Act
U.S.C.
United States Code
Cover Photo: Miscellaneous chemicals. (EPA image)
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July 27, 2018
x^fcD ST/ff.
• U.S. Environmental Protection Agency	18 P-0226
	 \ Office of Inspector General
mZ I
At a Glance
Why We Did This Project
The U.S. Environmental
Protection Agency (EPA),
Office of Inspector General
(OIG), conducted this audit to
determine (1) how the EPA is
ensuring that companies are
compliant with Chemical Data
Reporting (CDR) Rule
requirements under the Toxic
Substances Control Act (TSCA)
and (2) whether the EPA is
using CDR data to prioritize
chemicals for the purpose of
identifying their potential risks
to human health and the
environment.
Under the CDR Rule, the EPA
collects information about the
types, quantities and uses of
chemical substances produced
domestically and imported into
the United States. The EPA
uses this information, which
manufacturers and importers
are required to submit every
4 years, to screen and prioritize
chemicals for the purpose of
identifying potential human
health risks and environmental
effects, per the methodology
outlined in the agency's TSCA
Work Plan.
This report addresses the
following:
•	Ensuring the safety of
chemicals.
•	Compliance with the law.
Send all inquiries to our public
affairs office at (202) 566-2391
or visit www.epa.gov/oiq.
EPA's Chemical Data Reporting Rule Largely
Implemented as Intended, but Opportunities
for Improvement Exist
Implementing policies for data quality
checks will help tailor the information
reported by manufacturers and
importers to meet the EPA's needs
and improve its usefulness.
What We Found
As required by the TSCA, the EPA is
using CDR data to help assess the
risks of chemicals in U.S. commerce.
We determined that the EPA is
implementing the risk evaluation
process as outlined in its TSCA Work
Plan to assess chemicals for human health and environmental risks.
In addition, the EPA uses tools such as on-site inspections to monitor companies'
compliance with the CDR Rule, and the agency takes enforcement action when
violations are identified. However, we noted that while the EPA conducts data
quality checks of the chemical information submitted by companies every
4 years, the agency lacks documented policies and procedures that specify how
to select and conduct these data quality checks. Policies and procedures would
help the EPA implement future data quality checks that meet its information
needs, as well as help prevent the possible loss of institutional knowledge during
periods of staff turnover or absence.
We also noted that public stakeholders and EPA employees we interviewed cited
issues regarding accessing and extracting CDR information from the EPA's CDR
database. Our attempt at accessing information from the agency's database also
proved difficult. However, during the course of our audit, the EPA took steps to
help users more easily navigate the data by providing Microsoft Excel files and a
data dictionary. These improvements are intended to enhance the public's ability
to obtain information about chemicals in U.S. commerce.
Recommendation and Planned Agency Corrective Action
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention develop and implement a policy and/or procedures for how
the agency will conduct data quality checks of CDR Rule data submitted by
companies to the EPA.
The Office of Chemical Safety and Pollution Prevention concurred with our
recommendation and provided an acceptable corrective action with a milestone
date. The proposed corrective action, when completed, will meet the intent of the
recommendation.
Listing of OIG reports.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
July 27, 2018
MEMORANDUM
SUBJECT: EPA's Chemical Data Reporting Rule Largely Implemented as Intended,
but Opportunities for Improvement Exist
Report No. 18-P-0226
FROM: Arthur A. Elkins Jr.
TO:
Charlotte Bertrand, Acting Principal Deputy Assistant Administrator
Office of Chemical Safety and Pollution Prevention
This is our report on the subject audit conducted by the Office of Inspector General (OIG) of the
U.S. Environmental Protection Agency (EPA). The project number for this audit was OPE-FY17-0025.
This report contains findings that describe the problems the OIG has identified and corrective actions the
OIG recommends. This report represents the opinion of the OIG and does not necessarily represent the
final EPA position.
The EPA's Office of Chemical Safety and Pollution Prevention is responsible for implementing the
recommendation in this report.
In accordance with EPA Manual 2750, your office provided an acceptable corrective action and
milestone date in response to the OIG recommendation. The recommendation is resolved, and no final
response to this report is required. However, if you submit a response, it 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.
We will post this report to our website at www.epa.gov/oig.

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EPA's Chemical Data Reporting Rule	18-P-0226
Largely Implemented as Intended,
but Opportunities for Improvement Exist
		Table of C	
Purpose		1
Background		1
CDR Rule		1
EPA Chemical Risk Evaluation Process		2
EPA Monitors CDR Rule Compliance		4
Public Access to CDR Rule Data		5
Responsible Offices		5
Scope and Methodology		5
Results		6
EPA Uses CDR Data to Assess the Risks of Chemicals in Commerce		6
EPA Targets CDR Noncompliance Through Monitoring, Inspections
and Penalties		6
EPA Needs Policies and Procedures for CDR Data Quality Checks		10
EPA Can Improve CDR Data Transparency and Accessibility		11
Conclusions		12
Recommendation		12
Agency Response and OIG Evaluation		13
Status of Recommendations and Potential Monetary Benefits		14
Appendices
A Agency Response to Draft Report	 15
B Distribution	 17

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Purpose
The Office of Inspector General (OIG) of the U.S. Environmental Protection
Agency (EPA) conducted this audit to determine the following:
•	How the EPA is ensuring that companies are compliant with Chemical
Data Reporting (CDR) Rule requirements under the Toxic Substances
Control Act (TSCA).
•	Whether the EPA is using CDR data to prioritize imported and
manufactured chemicals for the purpose of identifying the potential for
human health and environmental risks.
Background
CDR Rule
The TSCA provides the EPA with the authority to develop reporting, record-
keeping and testing requirements and to establish restrictions relating to chemical
substances and/or mixtures. Since the TSCA was enacted in 1976, the EPA has
taken a number of actions to support its statutory responsibilities:
•	In 1977, the EPA promulgated a rule under TSCA Section 8(b), 15 U.S.C.
§ 2607(a), that requires the agency to compile an inventory of chemical
substances in commerce. This inventory is referred to as the TSCA
Inventory.
•	In 1986, the EPA promulgated the Inventory Update Rule (IUR) under
Section 8(a) of the TSCA to facilitate the periodic update of information
about chemical substances listed in the TSCA Inventory. The IUR also
supports other activities associated with the implementation of the TSCA.
•	In 2003, the EPA promulgated extensive amendments to the IUR that
require the reporting of additional data for certain chemicals to assist the
EPA in screening potential exposures and risks.
•	In 2007, the EPA identified areas where IUR data collection could be
improved to allow the agency to better identify and take follow-up action
on chemicals that may pose potential risks to human health or the
environment.
•	In 2011, the EPA amended the IUR, changing its name to the CDR Rule.
This name change was intended to better reflect the distinction between
CDR data collection, which includes exposure-related data, and the TSCA
Inventory itself, which only involves chemical identification information.
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During the CDR rulemaking process, which the agency undertook in 2011, the
EPA outlined its four primary goals for the reporting of chemical data (Table 1).
Table 1: Primary goals of the CDR rulemaking

Goal
1
Tailor the CDR information collected to better meet the EPA's overall information needs.
2
Increase the EPA's ability to effectively provide public access to CDR information.
3
Obtain new and updated information relating to potential exposures to a subset of
chemical substances listed on the TSCA Inventory.
4
Improve the usefulness of the information reported.
Source: TSCA Inventory Update Reporting Modifications; Chemical Data Reporting, Final Rule.
In the preamble to the final CDR Rule, the EPA stated that it believes the goals
outlined in Table 1 can be accomplished in two ways:
1.	Expanding the range of chemical substances for which more in-depth
processing and use information is to be reported.
2.	Adjusting the specific information to be reported, the method and
frequency of collecting that information, and confidential business
information (CBI) requirements.
Under the CDR Rule, the EPA collects basic exposure-related information from
manufacturers (including importers) on the types, quantities and uses of chemical
substances produced domestically or imported into the United States. This
information constitutes the most comprehensive source of basic exposure-related
data on chemicals available to the EPA, and it is used by the agency to assess
potential chemical risks to human health and the environment.
Manufacturers (including importers), with certain exceptions, are required to
report CDR data every 4 years on chemicals in commerce when yearly production
volumes for those chemicals are 25,000 pounds or greater during that 4-year
reporting cycle. If manufacturers meet or exceed the yearly production volume in
any 1 year (or more) of that cycle, they must report yearly production volumes for
all 4 years. Collecting the information every 4 years provides the EPA and the
public with up-to-date information on chemicals that are produced in large
quantities.1 For the 2016 CDR 4-year reporting cycle, which comprised
years 2012-2015, the EPA received information from 2,247 companies regarding
8,707 chemicals in commerce.
EPA Chemical Risk Evaluation Process
A primary use of CDR data is in the EPA's chemical risk evaluation process. The
EPA developed a TSCA Work Plan Chemicals: Methods Document in 2012 to
1 The public only has access to non-CBI for these chemicals.
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identify existing chemicals with the highest potential for exposure and hazard; to
assess those chemicals as part of the agency's chemical safety program; and, if
warranted, to subject those chemicals to risk reduction actions. The work plan
methodology details the use of hazard, exposure and persistence/bioaccumulation
criteria;2 the use of data sources; and how the EPA scores chemicals to identify
candidate chemicals for further assessment. The initial 2012 TSCA Work Plan
resulted in the identification of 83 chemicals for the EPA to assess.
In 2014, the EPA issued an updated work plan to reflect updated industry data
about chemical releases and potential exposures submitted to the EPA through the
2011	Toxics Release Inventory3 and the 2012 TSCA CDR cycle. The updated
2014 TSCA Work Plan identified a total of 90 chemicals for the EPA to assess.
This updated work plan modified the original list of 83 chemicals identified in
2012	by "removing 15 of the original chemicals ..., consolidating one chemical,
and adding 23 chemicals."
In 2016, the TSCA was amended by the Frank R. Lautenberg Chemical Safety for
the 21st Century Act. The amended TSCA provided a framework for progressing
the understanding and management of risks associated with existing chemicals, with
the goal of preventing unreasonable risks posed by the manufacturing, processing,
distribution, use or disposal of these chemicals. The act requires the EPA to identify
high- and low-priority chemicals and to evaluate high-priority chemicals against a
new risk-based safety standard. By December 2019, the EPA must complete risk
evaluations for the first 10 high-priority chemicals, ramp up the risk evaluation
process so that 20 high-priority chemicals are under evaluation at all times, and
identify 20 low-priority chemicals that will not undergo further evaluation.
The EPA's chemical risk evaluation process for assessing the safety of existing
chemicals consists of three stages:
•	During the prioritization stage, the EPA conducts a risk-based screening
process to designate chemical substances as either high-priority or low-
priority substances for risk evaluation.
•	The chemicals designated as high-priority substances undergo a risk
evaluation, which determines whether these chemicals, under the
2	Hazard criteria are used to assess risks to human health (e.g., carcinogenicity and toxicity), while exposure criteria
are used to assess how widely used the chemicals are (e.g., in consumer products or commercial use) and where they
can be found (e.g., in drinking water or indoor air). Persistent and bioaccumulation criteria are used to assess how
long organisms will possibly remain exposed to the chemicals.
3	Unlike the TSCA Inventory, which lists all chemicals in commerce, the Toxics Release Inventory tracks the
management of toxic chemicals that may pose a threat to human health and the environment. U.S. facilities in
different industry sectors must report annually how much of each chemical listed in the Toxics Release Inventory is
released to the environment and/or managed through recycling, energy recovery and treatment.
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conditions of use,4 present an unreasonable risk to human health or the
environment. Chemicals designated as low-priority substances are taken
out of consideration for further assessment at this time.
• If the EPA determines that a chemical presents an unreasonable risk to
health or the environment, the chemical then enters the risk management
stage. At this point, the EPA imposes regulatory restrictions on the
manufacture, processing, distribution, use or disposal of this chemical to
eliminate the unreasonable risks.
Figure 1 illustrates the three stages of this risk evaluation process.
Figure 1: EPA chemical risk evaluation process
Impose Restrictions to
Eliminate the
Unreasonable Risk
EPA determination of
Unreasonable Risk
Chemical designated
High-priority
for Risk Evaluation
EPA determination of
No Unreasonable Risk
Chemical designated
Low-Priority
Prioritization
Risk Evaluation
Risk Management
Source: The EPA, "How EPA Evaluates the Safety of Existing Chemicals" webpage.
In 2016, the EPA announced the first 10 high-priority chemicals that it had
identified to undergo risk evaluation, as required by the amended TSCA. In
addition, the EPA continues to consider strategies for the future use of CDR data
for pre-prioritization and risk assessment. On December 11, 2017, the EPA held a
public meeting to focus on possible approaches for identifying candidate
chemicals to be prioritized for the risk assessment process under the TSCA. The
EPA described and took comments regarding a number of possible approaches
that could guide the agency in this identification process.
EPA Monitors CDR Rule Compliance
The Office of Enforcement and Compliance Assurance (OECA) monitors
compliance with the CDR Rule and takes enforcement actions against companies
4 The term conditions of use refers to the circumstances, as determined by the EPA, under which a chemical
substance is intended, known or reasonably foreseen to be manufactured, processed, distributed in commerce, used
or disposed of.
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that are not compliant with CDR requirements. OECA oversees compliance and
enforcement pertaining to the manufacture, import, use, processing and
distribution of chemicals in U.S. commerce. Under the New and Existing
Chemicals Program, which is known as the Core TSCA Program, OECA works
with five participating EPA regional offices to execute its CDR Rule compliance
and enforcement responsibilities. The Core TSCA Program is a federal-only
program; there is no state compliance monitoring or enforcement.
Public Access to CDR Rule Data
The EPA makes non-CBI CDR data available to the public. The EPA's
2016 CDR cycle database and ChemView database, both available on the
agency's website, provide the public, government officials, nongovernmental
organizations and industry with access to non-CBI data regarding the
manufacture, import, processing and use of chemicals in commerce.
Responsible Offices
The Office of Pollution Prevention and Toxics (OPPT), within the Office of
Chemical Safety and Pollution Prevention, is responsible for implementing the
CDR Rule. Under the TSCA and the Pollution Prevention Act, the OPPT
evaluates new and existing chemicals and their risks. The Office of Civil
Enforcement and the Office of Compliance, both within OECA, are responsible
for monitoring compliance with the CDR Rule and taking enforcement action
against companies that are not compliant with CDR requirements.
Scope and Methodology
We conducted this performance audit from September 2017 through June 2018 in
accordance with generally accepted government auditing standards. These
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 objectives. We believe that the evidence obtained provides a
reasonable basis for our findings and conclusions based on our audit objectives.
We reviewed the TSCA, as amended by the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, and the federal regulations for implementing the CDR
Rule. We reviewed the EPA's policies, procedures, guidance and TSCA work
plans. We reviewed compliance and enforcement information, including the
OECA TSCA compliance monitoring strategy; the EPA TSCA enforcement
response and penalty policy; and inspection, enforcement and penalty
information. We also reviewed documentation related to the EPA's quality
assurance and quality control activities for CDR data.
We interviewed EPA headquarters (HQ) management and staff within the Office
of Chemical Safety and Pollution Prevention and OECA, as well as
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representatives from an environmental nongovernmental organization and an
industry trade association. We also queried the EPA's publicly available CDR
data to better understand the transparency and ease of use of the data.
Results
The EPA uses CDR data to prioritize imported and manufactured chemicals to
undergo the chemical risk evaluation process for potential human health and
environmental risks. In addition, the EPA uses tools—such as inspections and
data quality checks of submitted chemical data—to verify that companies are
compliant with CDR Rule requirements, and the agency takes enforcement
actions as appropriate. However, some improvements can be made to the internal
controls for CDR data quality checks so that the EPA can adapt to shifting
environments, evolving demands, changing risks and new priorities.
EPA Uses CDR Data to Assess the Risks of Chemicals in Commerce
The EPA uses CDR data, along with additional
exposure and hazard data sources, to assess the
risks of chemicals in commerce, as required by
the TSCA.
Through our analysis of documents and
interviews with EPA personnel, we determined
that the EPA is implementing the risk evaluation
process documented in its TSCA Work Plan and
is using CDR data to assess chemicals with the highest potential for exposure and
hazard according to this work plan.
EPA Targets CDR Noncompliance Through Monitoring, Inspections
and Penalties
As one component of the EPA's Core TSCA Program, OECA works with five
participating EPA regional offices to monitor compliance and take enforcement
actions against companies in violation of CDR Rule requirements.
Since fiscal year 2001, the Core TSCA Program has been centralized in OECA
HQ, except for a field presence at EPA Regions 2, 4 and 5. According to OECA
management, OECA has been working with the regional offices since fiscal year
2016 to re-establish a Core TSCA Program enforcement presence. As of
April 2018, OECA and EPA Regions 2, 3, 4, 5 and 9 conduct compliance
monitoring activities and enforcement. EPA Regions 1, 6, 7, 8 and 10 do not
participate in the Core TSCA Program. These regions make referrals to OECA for
review and potential follow-up.
Chemicals released into the
environment as a result of their
manufacture, processing, use or
disposal can threaten human
health and the environment.
The EPA gathers and assesses
information about the risks
associated with chemicals, and it
implements risk management
strategies when needed.
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According to OECA staff, there are approximately five full-time employees at HQ
dedicated to Core TSCA compliance monitoring and enforcement. The five
participating EPA regions use, on average, one and one-half full-time employees
for Core TSCA Program activities.
The OECA Compliance Monitoring Strategy for the Toxic Substances Control Act
(TSCA) (2016) provides overarching, multiyear guidance on developing and
implementing compliance monitoring activities for the Core TSCA Program.
When a potential CDR violation is suspected, OECA and regional offices may use
the following compliance monitoring tools found in the TSCA compliance
monitoring strategy:
•	Telephone inquiries with a potential violator that may provide the EPA
with useful information regarding compliance and/or that may clarify
previously reported data.
•	Information request letters to formally request the submission of
additional information or records by a potential violator. This tool can be
particularly effective when followed by on-site inspections.
•	Subpoenas to request additional information from a potential violator to
determine compliance. Subpoenas can be issued in lieu of conducting an
inspection.
•	Desk inspections or audits, where EPA staff conduct a documentary
inspection (e.g., review and analyze documents submitted in response to
an information request).
•	On-site inspections of a company's facility to determine compliance.
Inspections can be for-cause in response to a suspected violation or tip,
criteria-based in response to selected criteria or targeting, or neutral
scheme for general deterrent effects.
The fiscal years 2016-2017 OECA National Program Manager Guidance
suggests that regions implementing the Core TSCA Program focus on the
2016 CDR Rule requirements when conducting monitoring activities.5 OECA HQ
staff said that their highest priority for CDR Rule monitoring and enforcement
activities is nonreporting companies. OECA also listed other priorities, such as
priority chemicals, sectors with lapsed review and facilities in remote locations.
OECA said that staff review the EPA's internal data from the CDR cycle and
ChemView databases, as well as data from external sources and the internet, to
identify leads about potential noncompliance related to companies, specific
5 The fiscal years 2018-2019 OECA National Program Manager Guidance directs EPA regions to adhere to the
OECA Compliance Monitoring Strategy as appropriate for TSCA programs.
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chemicals of concern being manufactured or imported, or industrial sectors.
OECA also coordinates with the Office of Chemical Safety and Pollution
Prevention to identify particular focus areas for CDR compliance monitoring,
address questions about which chemicals are required to be reported under the
CDR Rule, and participate in quarterly conference calls to discuss topics related
to the CDR Rule.
OECA HQ staff said that previously submitted CDR data are used for both data
mining and targeting the office's compliance and enforcement activities. For data
mining, OECA has reviewed CDR data from past reporting cycles to identify
companies that did not report chemicals in the current CDR cycle that were reported
in previous CDR cycles. For enforcement activities, OECA has used CDR data to
identify manufacturers of certain chemical compounds that are in close proximity to
impacted communities or contaminated water supplies. OECA HQ staff said that
CDR data are also used to identify trends and target on-site inspections.
Core TSCA Inspections
OECA HQ staff said that they typically conduct 20-25 Core TSCA
inspections per year (Table 2). In addition to OECA HQ, EPA Regions 2, 3, 4,
5 and 9 also conduct Core TSCA inspections. OECA HQ staff said that
most—if not all—Core TSCA inspections of a company's facility include a
CDR compliance review.
Table 2: Core TSCA inspections conducted by EPA region

EPA region

Fiscal year
2
3
4
5
9
HQ a
Total
2013
5
0
15
0
0
28
48
2014
5
0
16
9
0
27
57
2015
8
0
13
5
0
27
53
2016
12
2
14
1
14
25
68
2017
12
3
16
1
23
b0
55
Total inspections
42
5
74
16
37
107
281
Source: EPA Integrated Compliance Information System.
a OECA HQ conducts Core TSCA inspections on behalf of EPA Regions 1, 6, 7, 8
and 10.
b According to OECA management, in fiscal year 2017, HQ staff conducted joint
inspections with EPA Regions 3 and 9. These inspections were recorded in the
agency's Integrated Compliance Information System as regional inspections.
An OECA HQ inspector we interviewed said that companies are typically
given advance notice of an inspection and what information they will need to
provide for review. Some companies will then aggregate data and prepare
quality control procedural documentation, flow charts and other records that
an inspector will use to identify types of chemicals, including any
intermediate chemicals, byproducts and other chemicals that are exempt from
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the CDR Rule. The inspector said that during this review, the EPA and
companies have the opportunity to identify any gaps or deficiencies in the data
that the companies are reporting to the agency under the CDR Rule. In some
cases, these inspections can result in an EPA request for additional
information from a company or the detection of a violation.
Core TSCA Enforcement
Violations of the CDR Rule found by the EPA during an inspection or other
compliance monitoring can include nonreporting of chemicals; late reporting;
false, incorrect or misleading reporting; or failure to report after the EPA has
requested missing information or a correction of erroneous information. For
example, in fiscal year 2016, the EPA found that several companies failed to
report the manufacture or import of multiple chemicals and that other
companies submitted production data after the CDR deadline had passed.
When a violation is found, the EPA can issue a notice of noncompliance,
assess a civil penalty, seek injunctive relief or criminal sanctions, or perform
some combination of these actions. According to the EP A's Enforcement
Response Policy for Reporting and Recordkeeping Rides and Requirements
for TSCA Sections 8, 12, and 13 (1999), an administrative civil penalty is the
appropriate response for most violations. Not all enforcement actions taken
are a result of inspections. For example, under the EPA's audit policy,
companies can voluntarily disclose to the EPA violations of the CDR rule in
exchange for penalty reductions. From fiscal year 2013 through fiscal year
2017, the EPA has taken 49 enforcement actions with penalties assessed at
over $6 million (Table 3).
Table 3: CDR enforcement actions and penalties
Fiscal year
EPA region
Total
2
3
4
5
9
HQ a
2013
1
0
2
2
0
3
8
2014
0
0
6
0
0
1
7
2015
0
0
4
0
1
0
5
2016
3
0
6
0
0
5
14
2017
3
1
5
0
2
4
15
Total enforcement actions
7
1
23
2
3
13
49
Total penalties assessed
$729,270
$18,063
$1,776,557
$157,099
$337,845
$3,446,653
$6,465,487
Source: The OIG.
a OECA HQ conducts inspections and takes enforcement actions on behalf of EPA Regions 1,6,7,8 and 10
since those regions do not currently participate in the Core TSCA Program.
The EPA is using CDR data not only to prioritize chemicals for risk
evaluation but also as tools to help target potential noncompliance with the
CDR Rule.
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EPA Needs Policies and Procedures for CDR Data Quality Checks
The EPA conducts quality checks of the chemical data submitted by companies to
determine whether data are submitted correctly and to look at chemical
information of interest to the agency. However, a lack of documented quality
assurance and quality control policies and procedures presents a risk that there
may be a loss of institutional knowledge about how data quality checks should be
conducted in cases of staff turnover or absence. Policies and procedures would
help the OPPT to more consistently implement future data quality checks to meet
the agency's information needs each reporting cycle.
According to the U.S. Government Accountability Office's Standards for Internal
Control in the Federal Government, GAO-14-704G (September 2014), program
managers should continually seek ways to improve accountability in achieving an
entity's mission. A key factor in improving
accountability is to implement an effective internal
control system, which helps an entity adapt to shifting
environments, evolving demands, changing risks and
new priorities.
For each 4-year CDR cycle, OPPT staff said that the
OPPT Chemical Control Division (CCD) team
determines what data areas the agency wants to examine (e.g., production volume
or where each chemical is used) and the conditions of each check or query. For
example, for the 2016 CDR cycle, the CCD conducted 30 different data quality
checks of chemical data submitted by companies. These checks included
production volumes, chemicals used in children's products, and chemicals that
were reported but were not required to be.
CCD staff said that the responsibility for selecting the data queries for each CDR
cycle depends on who is on the CCD CDR team at each 4-year interval. Some
queries are removed, added and modified based on CCD CDR team feedback. For
the 2020 CDR cycle, OPPT staff projected that some of the 30 data quality checks
from the 2016 reporting cycle will be replaced with new queries. Once the queries
are selected, the OPPT Information Management Division builds a database of the
requested information so that OPPT staff can run the queries.
CCD staff said that data quality checks have helped to identify reporting errors.
For example, in the 2016 CDR reporting cycle, one company misreported an
industrial use chemical as being intended for use in children's products. These
checks have also, in some cases, alerted the OPPT to CBI issues or resulted in
referrals to OECA.
For the 2016 reporting cycle, CCD staff developed a summary document that lists
which CDR data reporting fields should be used for each individual data check or
query, how the data should be displayed, and the results. The CCD said that this
Known as The Green Book, the Standards
for Internal Control in the Federal
Government provides managers with
criteria for designing, implementing and
operating an effective internal control
system. The Green Book defines the
standards through components and
principles and explains why they are integral
to an entity's internal control system.
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document can be used by staff for future reference during the next reporting cycle.
Another summary document developed by the CCD provides a detailed overview
of some of the steps and challenges associated with data quality checks during the
2016 reporting cycle. However, none of these documents describe the overall data
quality check process, such as how roles and responsibilities should be assigned
based on division or staff position, how queries should be selected, or what
general processes and steps should be followed when conducting a data quality
check. Policies and procedures would help the OPPT consistently implement data
quality checks for each CDR cycle and meet the agency's information needs.
EPA Can Improve CDR Data Transparency and Accessibility
CDR data inform the EPA, other agencies and the
public about chemicals manufactured in, imported
into and used in the United States. In addition, an
EPA website provides the public, government
officials, nongovernmental organizations and
industry with access to non-CBI data regarding the
manufacture, import, processing and use of chemicals in commerce. Making CDR
data readily available to the public enhances the transparency and accuracy of
EPA prioritization, assessments and regulatory development.
Difficulties Extracting Data from the CDR Database
Nongovernmental organization and industry stakeholders we interviewed
identified difficulties accessing the CDR data in the publicly available
database. These stakeholders stated that the CDR database platform lacks
functionality for public use of information. In addition, the stakeholders said
that the system could use updates to make it user friendly and that data
reporting, analysis and dissemination systems for the CDR are not reflective
of current technologies or practices.
EPA staff also cited issues accessing the agency's database. According to
EPA staff, the system is not user-friendly, and extracting data is a grueling
process for anyone not familiar with the system. In addition, EPA staff stated
that it is very difficult for them to query the system and that system queries
could not be easily viewed. EPA staff reported that they have identified and
use "workarounds" to complete their queries.
To test CDR data transparency and accessibility, we accessed the public CDR
cycle database to conduct queries. We queried two of the 10 priority
chemicals that the EPA identified in 2016 for risk evaluation, per the amended
TSCA: Trichloroethylene and 1-Bromopropane. For both chemicals, we
queried the database for the total pounds of aggregate production volume and
the total number of manufacturers and importers for each; this information is
used by the agency to identify chemicals for a risk evaluation. We were able
Under the EPA's fiscal years
2018-2022 strategic plan
(Objective 2.2), the EPA aims
to increase transparency and
public participation with
industry, environmental groups
and other stakeholders.
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to obtain the information but noted that accessing data from the public
database required downloading a Microsoft Access database to run queries.
When opened in Access, the data were displayed in a series of specific tables
and queries. We had difficulty identifying the correct tables or queries to
retrieve information about these chemicals due to our unfamiliarity with the
data and the fields within the database. In addition, the category names of the
fields were not easily identifiable. We searched for but were unable to find an
online user guide for the database. We contacted the agency staff and
requested access to a user guide, and we were informed that a user guide and
data dictionary were under development.
Since our communication with agency staff regarding CDR data access issues,
the EPA has provided additional options for accessing CDR data. The EPA's
website, Chemical Data Reporting under the Toxic Substances Control Act,
has been updated to include Microsoft Excel files (specifically, Comma
Separated Values files) that contain 2016 CDR public database information.
The EPA has also provided a data dictionary on this website, with the stated
purpose of providing users with assistance in navigating CDR data.
Conclusions
The EPA uses CDR data to prioritize imported and manufactured chemicals for
the purpose of identifying their potential risks to human health and the
environment. The agency also uses tools—such as targeted inspections,
enforcement actions, and data quality checks of company submitted data—to
determine whether companies comply with the CDR Rule. However, policies
and/or procedures for data quality checks would help tailor information to meet
the EPA's needs and improve the usefulness of information reported.
As a result of our audit, the EPA made publicly available on its website Excel
files to improve access to CDR information and a data dictionary to help users
navigate the CDR data. Improving public accessibility to CDR data helps the EPA
to increase the agency's ability to effectively provide public access to CDR
information—which ultimately enhances the public's ability to obtain exposure-
related information about chemicals in U.S. commerce.
Recommendation
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention:
1. Develop and implement a policy and/or procedures that identify staff
roles, staff responsibilities and the general process for how the agency will
conduct data quality checks of Chemical Data Reporting Rule data each
reporting cycle.
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Agency Response and OIG Evaluation
The Office of Chemical Safety and Pollution Prevention concurred with
Recommendation 1 and provided an acceptable corrective action and planned
milestone date. Recommendation 1 is resolved with corrective action pending.
In addition to a response to our recommendation, the agency provided technical
comments on the draft report. Based on the technical comments received, we made
revisions to the report where appropriate. Appendix A contains the complete
agency response.
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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)
1 12 Develop and implement a policy and/or procedures that identify	R Assistant Administrator for 10/25/18
staff roles, staff responsibilities and the general process for how	Chemical Safety and
the agency will conduct data quality checks of Chemical Data	Pollution Prevention
Reporting Rule data each reporting cycle.
C = Corrective action completed.
R = Recommendation resolved with corrective action pending.
U = Recommendation unresolved with resolution efforts in progress.
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Appendix A
Agency Response to Draft Report
PR01fe
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D C. 20460
"JUL -3 2018
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
MEMORANDUM
SUBJECT: Response to Draft Report entitled "EPA's Chemical Data Reporting Rule Largely
Implemented as Intended, but Opportunities for Improvement Exist."
This memorandum is in response to the Office of Inspector General's (OIG's) June 11, 2018,
Draft Report entitled "EPA's Chemical Data Reporting Rule Largely Implemented as Intended,
but Opportunities for Improvement Exist," Project No. OPE-FY17-0025.
The Office of Chemical Safety and Pollution Prevention (OCSPP) appreciates the OIG's effort in
evaluating the following:
•	Whether the EPA is using Chemical Data Reporting (CDR) data to prioritize imported
and manufactured chemicals for identifying the potential for human health and
environmental risks.
•	How the EPA is ensuring that companies are compliant with CDR Rule requirements
under the Toxic Substances Control Act (TSCA).
OCSPP agrees with OIG's evaluation of how the agency uses CDR data and ensures that
companies are compliant with requirements.
FROM: Charlotte Be
Acting Principal Deputy Assistant Administrator
TO:
Arthur A. Elkins Jr.
Inspector General
I. General Comments
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II.
OCSPP's Response to the Recommendation:
Recommendation 1: Develop and implement a policy and/or procedures that identify staff roles,
staff responsibilities and general process for how the agency will conduct data quality checks of
Chemical Data Reporting Rule data each reporting cycle.
OCSPP Corrective Action: OCSPP will develop a standard operating procedure document that
describes roles and responsibilities and the process to ensure that quality Chemical Data
Reporting information is received and used by the agency.
Target Completion Date: October 25, 2018.
cc: Janet L. Weiner, OCSPP
John Latham Jr., OPPT
Bobbie Trent, OCFO
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Appendix B
Distribution
The Administrator
Deputy Administrator
Chief of Staff
Chief of Operations
Special Advisor, Office of the Administrator
Assistant Administrator for Chemical Safety and Pollution Prevention
Assistant Administrator for Enforcement and Compliance Assurance
Regional Administrators, Regions 1-10
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for Public Affairs
Principal Deputy Assistant Administrator for Enforcement and Compliance Assurance
Deputy Assistant Administrator for Chemical Safety and Pollution Prevention
Deputy Assistant Administrator for Enforcement and Compliance Assurance
Director, Office of Continuous Improvement, Office of the Administrator
Director, Office of Regional Operations
Director, Office of Pollution Prevention and Toxics, Office of Chemical Safety and
Pollution Prevention
Director, Office of Civil Enforcement, Office of Enforcement and Compliance Assurance
Director, Office of Compliance, Office of 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 Coordinators, Regions 1-10
Audit Follow-Up Coordinator, Office of Pollution Prevention and Toxics, Office of Chemical
Safety and Pollution Prevention
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