U.S. ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF INSPECTOR GENERAL 

Catalyst for Improving the Environment 

Evaluation Report 

EPA Needs a Coordinated Plan to 

Oversee Its Toxic Substances 

Control Act Responsibilities 

 Report No. 10-P-0066 

 February 17, 2010 
 

 

 

 

 

 

 

 

Report Contributors:	 Steve Alderton 

 Natasha Besch-Turner 

Stacey Bond 

 Jill Ferguson 

 Manju Gupta

 Natalie Hanson

 Jeffrey Harris 

 Calvin Lin

 John Patrick

 Michael Wilson 

Abbreviations 

CBI Confidential Business Information 

EPA U.S. Environmental Protection Agency 

FY Fiscal Year 

NOC Notice of Commencement 

OECA Office of Enforcement and Compliance Assurance 

OECD Organisation for Economic Cooperation and Development 

OIG Office of Inspector General 

OPPT Office of Pollution Prevention and Toxics 

OPPTS Office of Prevention, Pesticides, and Toxic Substances 

PMN Premanufacture Notice 

SNUR Significant New Use Rule 

TSCA Toxic Substances Control Act 

Cover: From left to right: Toxic chemicals (photo courtesy New York State Department of 

Environmental Conservation); chemical testing (photo courtesy EPA); storage tanks 

at a chemical facility (photo courtesy U.S. Department of Homeland Security). 
 

 

 

U.S. Environmental Protection Agency 10-P-0066 

February 17, 2010 Office of Inspector General 

At a Glance 

Catalyst for Improving the Environment 

Why We Did This Review EPA Needs a Coordinated Plan to Oversee Its 

We conducted this evaluation Toxic Substances Control Act Responsibilities 

to review the U.S. 

Environmental Protection 

Agency’s (EPA’s) 

implementation of the Toxic 

Substances Control Act 

(TSCA) by determining how 

well EPA’s processes for 

oversight and regulation meet 

the objectives of TSCA, and 

whether the performance 

measures accurately reflect 

EPA’s assurance that the 

objectives of TSCA are met. 

Background 

EPA is responsible for ensuring 

that new chemicals entering 

commerce do not pose 

unreasonable risk to human 

health and the environment. 

The Office of Pollution 

Prevention and Toxics (OPPT) 

is responsible for reviewing 

industry submissions and 

managing risks from new 

chemicals. The Office of 

Enforcement and Compliance 

Assurance (OECA) provides 

assistance and monitors 

compliance. 

For further information, 

contact our Office of 

Congressional, Public Affairs 

and Management at 

(202) 566-2391. 

To view the full report, 

click on the following link: 

www.epa.gov/oig/reports/2010/ 

20100217-10-P-0066.pdf 

What We Found 

EPA does not have integrated procedures and measures in place to ensure that 

new chemicals entering commerce do not pose an unreasonable risk to human 

health and the environment. We found that EPA’s New Chemicals Program had 

limitations in three processes intended to identify and mitigate new risks – 

assessment, oversight, and transparency. The program is limited by an absence 

of test data and a reliance on modeling because TSCA does not require upfront 

testing as part of a Premanufacture Notice (PMN) submission. PMN submitters 

are required to submit health and safety data in their possession and a description 

of data known to or reasonably ascertainable by the submitter at the time of its 

submission. Nonetheless, the majority of PMN submissions do not include 

chemical toxicity or environmental fate data. Oversight of regulatory actions 

designed to reduce known risks is a low priority, and the resources allocated by 

EPA are not commensurate with the scope of monitoring and oversight work. In 

addition, EPA’s procedures for handling confidential business information 

requests are predisposed to protect industry information rather than to provide 

public access to health and safety studies. 

OPPT’s and OECA’s respective performance measures for managing risks from 

new chemicals do not accurately reflect program performance in preventing risk, 

nor do they assure compliance. In cases where full information does not exist or 

analyses are limited, OPPT reports the new chemicals as not having risk, while 

the limitations in the measure are not disclosed. OECA’s performance measure 

is not outcome based; rather, the measure tracks program activities. 

What We Recommend 

We recommend that EPA better coordinate risk assessment and oversight 

activities by establishing a management plan that contains new goals and 

measures that demonstrate the results of OPPT and OECA actions. We 

recommend that the Office of Prevention, Pesticides, and Toxic Substances 

establish criteria for selecting chemicals or classes of chemicals for low-level 

exposure and cumulative risk assessments, and develop confidential business 

information classification criteria to improve EPA’s transparency and 

information sharing. Finally, we recommend that OECA develop a management 

plan for Core TSCA enforcement that includes training, consistent enforcement 

strategies across regions for monitoring and inspection protocols, and a list of 

manufacturers and importers of chemicals for strategic targeting. The Agency 

agreed with our recommendations. 
 

 

 

 

 

 

 

 Assistant Inspector General 

 Office of Program Evaluation 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

INSPECTOR GENERAL 

February 17, 2010 

MEMORANDUM 

SUBJECT: EPA Needs a Coordinated Plan to Oversee Its 

Toxic Substances Control Act Responsibilities 

Report No. 10-P-0066 

FROM: Wade T. Najjum

TO: Bob Perciasepe 

 Deputy Administrator 

 Steve Owens 

Assistant Administrator for Prevention, Pesticides, and Toxic Substances 

 Cynthia Giles 

 Assistant Administrator for Enforcement and Compliance Assurance 

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

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

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. 

Final determinations on matters in this report will be made by EPA managers in accordance with 

established resolution procedures. 

The estimated cost of this report – calculated by multiplying the project’s staff days by the 

applicable daily full cost billing rates in effect at the time – is $786,181. 

Action Required 

In accordance with EPA Manual 2750, you are required to provide a written response to this report 

within 90 calendar days. You should include a corrective actions plan for agreed-upon actions, 
 

including milestone dates. We have no objections to the further release of this report to the public. 

This report will be available at: http:www.epa.gov/oig. 

If you or your staff have any questions regarding this report, please contact me at 202-566-0827 

or najjum.wade@epa.gov, Jeffrey Harris at 202-566-0831 or harris.jeffrey@epa.gov, or Jill 

Ferguson at 202-566-2718 or ferguson.jill@epa.gov. 
EPA Needs a Coordinated Plan to Oversee Its 10-P-0066 

Toxic Substances Control Act Responsibilities 

Table of Contents 

Chapters 

1 Introduction .......................................................................................................... 1
 

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

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

Noteworthy Achievements.............................................................................. 4 

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

2 EPA Lacks a Coordinated Process for Ensuring Risk Mitigation..................... 6 

Limitations of Risk Assessment of New Chemicals........................................ 6 

Limited Oversight of New and Existing Chemicals......................................... 7 

Lack of Systematic Collaboration between OECA and OPPT........................ 10 

Public Access to Health and Safety Data Not Assured .................................. 11
 

PMN Fees Do Not Defray EPA’s Costs.......................................................... 12 

Measures Do Not Reflect Performance ......................................................... 13
 

Conclusions ................................................................................................... 14 

 Recommendations ........................................................................................ 15 

Agency Comments and OIG Evaluation ........................................................ 16 

Status of Recommendations and Potential Monetary Benefits................................. 17 

Appendices 

A New Chemicals Program Logic Model ................................................................ 18 

B Agency Comments on Draft Report .................................................................... 19 

C Distribution ............................................................................................................ 25 
 

 

 

 10-P-0066 

Chapter 1

Introduction 

Purpose 

The objective of this evaluation was to assess the U.S. Environmental Protection 

Agency’s (EPA’s) implementation of the Toxic Substances Control Act (TSCA), 

with a focus on EPA’s policies, procedures, and authority for managing risks to 

human health and the environment posed by new chemicals. Specifically, we 

sought to answer the following questions: 

(1) How well do EPA processes for new chemical oversight and regulation 

meet the objectives of TSCA? 

(2) Do the performance measures accurately reflect EPA’s assurance that the 

objectives of TSCA are being achieved? 

Background 

In 1976, Congress passed the Toxic Substances Control Act to protect human 

health and the environment from risks associated with toxic chemicals.1 The Act 

authorized EPA to collect information on, and to regulate the production and 

distribution of, chemicals. TSCA required EPA to (i) create an inventory of 

“existing chemicals” already in commerce, (ii) regulate unreasonable risk from 

“new chemicals” introduced into commerce subsequent to the Act, and (iii) make 

health and safety information available for examination while protecting 

manufacturers’ confidential business information (CBI). 

TSCA authorized EPA to identify and regulate unreasonable risks from new 

chemicals prior to manufacture or import. However, TSCA limits EPA’s 

authority to require industry to conduct health and safety studies. Therefore, 

EPA’s oversight is largely dependent on available data on comparable chemicals 

and any information provided by manufacturers and importers. To request 

additional information on chemical safety from industry, EPA must first make a 

determination that the chemical presents an unreasonable risk. In addition, EPA 

must ensure that the burden of EPA’s request is commensurate with the potential 

harm from exposure to the new chemical. Although TSCA does not specifically 

authorize EPA to continually review the safety of a chemical once it enters 

commerce, Section 8(e) of TSCA requires producers and importers to maintain 

records and report to EPA any newly identified risks or harm from their chemicals 

– whether existing or new. 

1

 TSCA excludes chemicals in pesticides, food, pharmaceuticals, tobacco, and firearms that are regulated by other 

statutes. 

1 
 

 

 

 10-P-0066 

The New Chemicals Program 

Manufacturers and importers must submit a Premanufacture Notice (PMN) to 

EPA at least 90 days prior to introducing a new chemical into commerce. EPA’s 

multistep review process and tools to review PMNs are illustrated in Figure 1-1. 

Teams of EPA technical experts, including scientists, engineers, and toxicologists, 

use computer models to predict the potential toxic effects of a chemical based on 

available data. A PMN remains valid indefinitely once it has gone through the 

90-day review period regardless of when (or whether) the chemical is 

manufactured or imported. Within 30 days of manufacture or import, a Notice of 

Commencement (NOC) must be submitted to EPA, at which time EPA adds the 

substance to the TSCA inventory. 

Figure 1-1: New Chemicals Review Process 

Day 1 Days 8-12 Days 9-13 Days 15-19 Days 23-61 Days 79-82 Day 90 

Company 

withdraws PMN 

Final 

Decision 

Meeting 

<20% of 

PMNs go 

through 

further 

review 

Initial 

Risk 

Management 

Decision 

Meeting 

Hazard, Fate, 

& Exposure 

Meetings 

(includes 

structure 

activity 

relationship) 

Chemical 

Review 

Meeting 

New 

Chemicals 

PMN 

Regulatory 

action 

80% of PMNs 

are dropped 

from further 

review 

PMN dropped 

with no 

regulatory 

action 

Source: EPA. 

EPA can manage potential unreasonable risks found during the PMN review 

process through Consent Orders2 and Significant New Use Rules (SNURs).3 

Between 1996 and 2008, EPA received approximately 1,500 PMNs annually, on 

average. As illustrated in Figure 1-2, on average, less than 10 percent were 

regulated. 

2

 Through a Consent Order, EPA places certain conditions on the manufacture/import of the chemical, often 

including a requirement for more testing to be done on the chemical. 3

 A SNUR extends the requirements of a Consent Order to other manufacturers/importers, or puts restrictions on 

uses of the chemical other than those identified in the PMN. If EPA makes a determination that a chemical will 

cause harm to human health or environment, TSCA gives EPA authority to ban the chemical from manufacture or 

import. 

2 
 

 10-P-0066 

Figure 1-2: Average Fate of PMNs Submitted to EPA 

Withdrawn 

5% 

Regulated 

8% 

Not 

Regulated 

87% 

Source: EPA. 

TSCA also implements the intent of Congress that health and safety studies for 

chemicals introduced into commerce be made available to the public. However, 

manufacturers and importers can request protection of CBI in health and safety 

studies submitted pursuant to PMN and Section 8(e) notice requirements. 

Finally, TSCA directs that EPA collect a fee to defray the costs of assessing risks 

from new chemicals. The PMN fee is capped at $2,500 and $100 for large and 

small businesses, respectively. This fee cap has remained the same since TSCA 

was enacted in 1976. EPA began charging the fee in 1988. 

EPA’s Implementation and Oversight of TSCA 

Two offices at EPA are primarily responsible for implementing TSCA: the Office 

of Prevention, Pesticides, and Toxic Substances (OPPTS) and the Office of 

Enforcement and Compliance Assurance (OECA). Within OPPTS, the Office of 

Pollution Prevention and Toxics (OPPT) is responsible for reviewing submitter 

information and managing risks from new chemicals. As EPA’s compliance and 

enforcement arm, OECA is responsible for providing assistance, monitoring, and 

enforcing compliance with TSCA by inspecting manufacturers and importers. 

OPPT activities related to managing risk from new chemicals include: 

•	 Developing guidance and tools for PMN submission review 

•	 Reviewing PMNs and NOCs 

•	 Maintaining the TSCA and CBI inventories, with periodic updates from 

information received under the Inventory Update Rule 

•	 Restricting the manufacture of certain chemicals (based on results of 

PMN review) with Consent Orders and SNURs 

•	 Reviewing risk information identified on Section 8(e) notices 

•	 Making health and safety data available to the public 

3 
 

 

 

 

 10-P-0066 

OECA activities related to Core TSCA4 include providing compliance assistance 

and incentives as well as conducting inspections to ensure manufacturers and 

importers: 

•	 submit required notices to EPA such as PMNs and NOCs, 

•	 comply with terms of Consent Orders and SNURs, 

•	 report any newly identified risk or harm as Section 8(e) notices, 

•	 maintain all records of manufacturing, and adverse reactions to health or 

the environment by a chemical, as required by TSCA. 

Noteworthy Achievements 

EPA established an inventory of 62,000 existing chemicals when TSCA was 

enacted. Since then, EPA has added 23,000 new chemicals to the inventory. 

Through September 2008, EPA had regulated 1,432 chemicals by means of 

Consent Orders and issued a total of 1,415 SNURs. In addition, OPPT’s New 

Chemicals Program developed and shared risk assessment models with industry. 

Scope and Methodology 

Our evaluation focused on EPA’s strategy and processes for preventing risk from 

new chemicals under its Core TSCA responsibilities. Specifically, we evaluated 

how OPPT assesses and regulates risk from new chemicals through the PMN 

review process (TSCA Sections 5 and 8) and how OECA ensures compliance 

with Core TSCA submissions and manufacturing and importing restrictions 

(TSCA Sections 4, 5, 8, 12, and 13). We did not review EPA’s management of 

risk from “existing chemicals”; however, incidental references to existing 

chemicals are included when relevant to the current discussion. We also reviewed 

EPA’s policies and processes for making significant risk information from 

chemicals available to the public (TSCA Section 14). In addition, we reviewed 

the amount and history of the PMN submission fee (TSCA Section 26). We 

performed our evaluation between December 2008 and December 2009. 

We conducted literature reviews, interviewed EPA staff and external experts, and 

analyzed EPA processes, measures, and data. We evaluated OPPT goals, 

measures, and data related to the prevention of unreasonable risk from new 

chemicals, as well as OECA goals, measures, and data for compliance assistance, 

inspections, and enforcement for regions and Headquarters. Appendix A includes 

a logic model we developed to identify shared or overlapping responsibilities of 

OPPT and OECA for managing risk from new chemicals. The logic model also 

shows how their activities, outputs, and outcomes contribute to the meeting of 

4

 Core TSCA is the generic name for Title I that includes the major provisions of Sections 4, 5, 8, 12, and 13. TSCA 

consists of Title I: Control of Toxic Substance (also known as Core TSCA), and the subsequent amendments: Title 

II: Asbestos Hazard Emergency Response, Title III: Indoor Radon Abatement, and Title IV: Lead Exposure 

Reduction. 

4 
 10-P-0066 

EPA’s long-term goal of protecting human health and the environment from new 

chemical risks. 

We conducted this review in accordance with generally accepted government 

auditing standards. Those standards require that we plan and perform the review 

to obtain sufficient, appropriate evidence to provide a reasonable basis for our 

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

obtained provides a reasonable basis for our findings and conclusions based upon 

our objectives. 

5 
 

 

 

 10-P-0066 

Chapter 2

EPA Lacks a Coordinated Process for 

Ensuring Risk Mitigation 

EPA is responsible for meeting TSCA’s objective that new chemicals entering 

commerce do not pose an unreasonable risk to human health and the environment. 

However, EPA does not have integrated procedures and measures in place to 

ensure that it is achieving this objective. We found limitations in the three 

processes intended to identify and mitigate new risks – assessment, oversight, and 

transparency. EPA’s New Chemicals Program is limited by the absence of test 

data and a reliance on modeling, because TSCA does not require upfront testing 

as part of a PMN submission. PMN submitters are required to submit health and 

safety data in their possession and a description of data known to or reasonably 

ascertainable by the submitter at the time of their submission. Nonetheless, the 

majority of PMN submissions do not include chemical toxicity or environmental 

fate data. Oversight of regulatory actions designed to reduce known risks is a low 

priority, and the resources allocated by EPA are not commensurate with the scope 

of monitoring and oversight work. Finally, EPA’s procedures for handling CBI 

requests are predisposed to protect industry information rather than to provide 

public access to health and safety studies. 

Limitations of Risk Assessment of New Chemicals 

EPA’s New Chemicals Program is limited by an absence of test data and the 

resulting reliance on existing information and models to overcome data gaps. To 

perform new chemical reviews, OPPT uses the information manufacturers submit 

on PMNs. According to OPPT managers, approximately 50 percent of the PMN 

submissions contain no test data, and close to 85 percent contain no toxicity data. 

In addition, only a few submissions contain environmental effects and fate data 

for the chemical. In the absence of test data, OPPT must rely upon expert 

analyses, comparisons with structurally similar chemicals, and models in order to 

perform its risk assessments. Specifically, reviewers utilize analog data on other 

PMN chemicals, Section 8(e) data, modeling tools, and/or regulatory options to 

support screening-level risk assessments. 

External reviewers, including nongovernmental organizations, academics, and 

peers, have repeatedly expressed concerns that EPA’s New Chemicals Review 

Process is limited because of its dependence on risk assessment models. As far 

back as 1994, a review by the Organisation for Economic Cooperation and 

Development (OECD) found that due to a paucity of experimental data, EPA has 

to rely on predictive methods that estimate the properties of a chemical.5 

5

 Organisation for Economic Co-operation and Development, US EPA/EC Joint Project on The Evaluation of 

(Quantitative) Structure Activity Relationships, OCDE/GD(94)28, Environment Monograph No. 88, 1994. 

6 
 

 

 

 10-P-0066 

According to the OECD report, the models in use by OPPT at the time of its 

review had good predictive capabilities for ecotoxicity, but had limited predictive 

capabilities for general systemic health effects. 

More recently, Environmental Defense Fund scientists expressed concern that the 

models are not accurate in predicting risks from prolonged low-level exposure to 

chemicals. Currently, OPPT analyzes each new chemical in isolation without 

factoring in potential risks from multiple exposure pathways or from exposure to 

multiple chemicals. The National Research Council recently recommended that 

EPA revise its risk assessment process to assess cumulative exposure risks from 

multiple chemicals, because human health and environment are not exposed to 

one chemical at a time.6

 Additionally, pervasive CBI redactions inhibit 

independent peer reviews and oversight by independent and external 

knowledgeable parties.7 

In order to complete PMN risk assessments, OPPT also refers to information on 

similar existing chemicals found in EPA’s Integrated Risk Information System 

database. The database currently contains only 553 of the more than 80,000 

chemicals in the TSCA inventory. At present, just 67 of those 553 substances 

have complete toxicological information. 

The incomplete information available on existing chemicals further limits the 

amount of information upon which OPPT can assess the risk of new chemicals. 

Because OPPT depends on information reported by industry, it might miss 

chemical risks not self-disclosed by manufacturers. The models OPPT has 

developed are useful tools for estimating the risk of new chemicals, but are not as 

reliable as actual test data, particularly for some health threats. 

If no potential risks are identified within the 90-day review period, the chemical 

may be manufactured after submitting a NOC. However, given the limitations of 

the review process, EPA’s assurance that new chemicals or organisms introduced 

into commerce do not pose unreasonable risks to workers, consumers, or the 

environment is not supported by data or actual testing. 

Limited Oversight of New and Existing Chemicals 

Oversight of regulatory actions designed to reduce known chemical risks is a low 

priority. The resources allocated by EPA are not commensurate with the scope of 

monitoring and oversight work. One of OECA’s responsibilities is to develop 

strategies, tools, and priorities to ensure compliance with Core TSCA regulations. 

We found that OECA’s oversight of Core TSCA-regulated entities is inconsistent 

and presents a minimal presence. Further, OECA does not provide feedback to 

6

 Committee on the Health Risks of Phthalates, Phthalates and Cumulative Risk Assessment: The Tasks Ahead,
 

National Research Council, 2008.

7

 Denison, Richard A., “Ten Essential Elements in TSCA Reform,” Environmental Law Review, 2009. 

7 
 10-P-0066

OPPT regarding the results of its oversight activities, preventing an Agency 

assessment of how effectively EPA’s New Chemicals Program is implemented. 

 

Enforcement resources are not commensurate with the scope of work. The 

number of inspectors is declining and their allocation is not determined by 

potential risks. Over the course of the Core TSCA program, OECA has shifted 

responsibility for conducting inspections among regions; OECA headquarters; the 

Core TSCA Enforcement Center in Denver, Colorado; and combinations thereof. 

During the last resource shift in 2001, regions were offered the responsibility for 

ensuring compliance. Only Regions 2, 4, and 5 assumed responsibility for Core 

TSCA enforcement, while OECA Headquarters and the Core TSCA Enforcement 

Center assumed responsibility for the remaining seven regions. This dispersed 

responsibility has led to an inconsistent approach and process that hinders 

effective oversight. 

EPA claims that deterrence is an essential element in its environmental 

compliance monitoring and enforcement program. However, only 56 Core TSCA 

inspections were conducted in Fiscal Year (FY) 2008 in a universe that is 

estimated to include hundreds of thousands of regulated entities. We found that 

there was minimal or no oversight in some regions (i.e., 3, 6, 8, 9, and 10). Figure 

2-1 illustrates the trends in inspections from FY 2005 through FY 2008. 

According to Region 6 and 9 personnel, these two regions have a high 

concentration of chemical manufacturers and importers. Despite the large ports in 

Region 9 and numerous chemical manufacturers in Region 6, there are no TSCA 

inspectors to monitor compliance or coordinate with U.S. Customs and Border 

Protection inspections. Moreover, these regions are not informed of OECA 

inspections within their jurisdiction because OECA Headquarters staff does not 

coordinate inspections with these regions. 

Figure 2-1: Number of Core TSCA Inspections by EPA Region and Headquarters, 

 Fiscal Years 2005- 2008 

0

5

10

15

20

25

30

35

40

45

50

55

60

65

R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 HQ

EPA Regions (R) and Headquarters (HQ)

Number of Inspections 

FY 05

FY 06

FY 07

FY 08

 Source: OECA data. 
 

 

 10-P-0066 

OECA’s allocation of inspection resources to Core TSCA enforcement reflects 

Core TSCA’s low priority. Regions 2, 4, and 5 each have only one full-time 

equivalent employee conducting inspections. Until recently, OECA had tasked 

the oversight for the remaining regions to two inspectors in the Core TSCA 

Enforcement Center in Denver.8 The Acting Branch Chief of OECA’s Chemical 

Risk and Reporting Enforcement Branch explained that it is difficult to compete 

for EPA enforcement resources when other programs assess $10 million fines. 

OECA prioritizes EPA enforcement actions by outputs that will result in the 

highest fines rather than those that will reduce the most risk or exposure. Core 

TSCA’s low fines make TSCA a low priority among the statutes EPA enforces. 

Additionally, Core TSCA enforcement actions have decreased in the past 5 years 

(FY 2004 to 2008), and the total number of Core TSCA inspections conducted 

declined from FY 2005 to 2008 nationwide, from 114 inspections to 56. 

Figure 2-2 illustrates the variation and decline in Core TSCA enforcement 

actions. Between 1996 and 2008, a total of 193 Administrative Actions were 

completed for the Core TSCA violations identified. Regions 2, 4, and 5 (the three 

regions maintaining a Core TSCA enforcement presence) were responsible for 

over 50 percent of the penalties administered. 

Figure 2-2: Core TSCA Enforcement Actions, Fiscal Years 1996-2008 

0 

5 

10 

15 

20 

25 

30 

35 

40 

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008 

Fiscal Years 

Number of Actions

 Source: OECA data. 

Finally, OECA’s oversight of TSCA is hindered by an incomplete knowledge of 

the universe of manufactures and importers. With a lack of knowledge of the 

Core TSCA universe and low-level, geographically limited monitoring, OECA 

8

 Core TSCA oversight responsibilities are being centralized in Headquarters and the inspections previously 

conducted by OECA staff in Denver will be conducted by OECA contractors out of Washington, DC. 

9 
 

 

 10-P-0066 

cannot measure the impacts of its activities. OECA personnel we interviewed 

stated that the number of manufacturers and importers subject to Core TSCA 

regulations is large, but a complete list has not been identified as required.9 

Neither OECA nor the regional inspectors were able to provide us with the size of 

their regulated universe. However, both stated that the mix of the universe has 

changed and continues to change every year. They stated that the number of 

chemical manufacturers within the United States has decreased, while the number 

of importers has been increasing. This trend is a concern because inspectors 

believe that importers are at a higher risk of noncompliance. 

Lack of Systematic Collaboration between OECA and OPPT 

EPA implements TSCA through OPPT regulating risk from new chemicals 

entering commerce, and OECA monitoring industry for compliance with Core 

TSCA requirements and EPA regulatory actions. Although these activities are 

interconnected, EPA does not have an effective system in place requiring 

information sharing between the two activities. In addition, TSCA is not a shared 

priority between these two EPA programs. As a result, the two offices operate 

independently, each focusing its efforts only on the scope of work for which it is 

directly accountable. 

OECA depends on timely and current information from OPPT to effectively 

execute its monitoring and oversight activities. Specifically, OECA needs 

information from OPPT databases on PMNs, NOCs, and Section 8(e) notices. In 

return, OPPT needs OECA to ascertain that manufacturers and importers submit 

PMNs and NOCs for each new chemical that enters commerce. In addition, 

OPPT depends on OECA inspections to (1) ensure that the manufacturers and 

importers submit all studies and information that identify new risks from 

chemicals, and (2) provide assurance that industry complies with Consent Orders 

and SNURs. However, in examining the TSCA implementation process in its 

entirety, we found a lack of systematic and timely communication between OPPT 

and OECA. Some examples include: 

•	 According to EPA’s regional inspectors, as of May 2009, their scheduled 

monthly conference calls with OPPT and OECA had not been held in 5 

months. 

•	 As of May 2009, OPPT had not provided regional inspectors with the 

current data that industry periodically submits to EPA in accordance with 

the 2006 TSCA Inventory Update. 

•	 Inspectors reported that poor information sharing between OPPT, OECA, 

and regions was inhibiting the ability of inspectors to know their universe 

and select targets. 

•	 Because of the minimal presence of OECA’s Core TSCA activities, 

OPPT does not receive convincing feedback on industry’s level of 

9 OECA’s Operations Manual for the Core TSCA Compliance and Enforcement Program, February 2003. 

10 
 10-P-0066 

compliance with their regulated actions, nor on whether industry is 

providing all required studies and risk information to OPPT. 

The lack of collaboration between OECA and OPPT results in an uneven 

emphasis placed on the screening and regulation of new chemicals, with minimal 

follow-up and compliance assurance. The success of the New Chemicals 

Program depends on comprehensive screening, regulating when there is potential 

risk through regulatory actions (Consent Orders, SNURs, and/or bans), and 

support by vigilant and frequent monitoring of the regulated entities. However, 

EPA does not have effective guidance or a plan for shared priorities and 

accountabilities between OPPT and OECA. 

Public Access to Health and Safety Data Not Assured 

Another objective of TSCA is for chemical health and safety data to be made 

available to the public. However, we found that EPA’s current process for 

handling CBI requests is weighted toward the protection of industry information 

rather than public access. Current CBI procedures, based on the TSCA statute, 

also do not allow EPA to discuss CBI with other countries such as Canada or the 

European Union unless companies provide permission to do so. TSCA provides 

protection for data that reveal the manufacturing processes of a chemical or 

mixture, and data that reveal the composition of a mixture. According to OPPT’s 

Chief of TSCA Security Staff, companies are required to address a series of 

substantiation questions when requesting confidentiality for information 

submitted under TSCA. The CBI requests granted by EPA apply to information 

including the chemical manufacturer, chemical name, facility location, and 

quantity of chemical produced. When such basic information is assigned 

permanent CBI protection, the public cannot be fully informed about the health 

and safety data. The health and safety data are of limited value, for example, if 

the chemical the data pertain to is unknown. An increased disclosure of health 

and safety data would also provide academia and researchers information on risk 

data that could be used for further independent studies and external oversight. 

The OPPT Chief of TSCA Security Staff estimated manufacturers and importers 

are sending a large percentage of submissions with requests for CBI protection (as 

high as 90 percent of PMNs and 50 percent of Section 8(e) notices). Despite the 

intention of TSCA to provide access to health and safety data, OPPT does not 

conduct any systematic verification or validation of the requests, instead deferring 

to the submitter’s determination. EPA administratively tracks the presence or 

absence of CBI requests but does not comprehensively assess the merit of the 

claims. In some cases, the information claimed as CBI is publicly available 

through the manufacturer’s advertising materials or even other EPA databases. 

Furthermore, the current procedures for submitting PMNs and Section 8(e) 

notices allow manufacturers and importers to make the determination with regard 

to the length of time they would like CBI protection. Commonly, CBI 

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designations have no expiration date. Since there is no systematic verification or 

validation done for CBI requests, CBI protection on information in health and 

safety studies can potentially remain in effect indefinitely and, in some cases, 

incorrectly. For example, after a recent review of TSCA Inventory Update 

submissions (some dating back to 1998), EPA announced it will release 

information on 530 chemicals after finding that, without requests from submitters, 

it had needlessly provided confidential treatment for the chemical’s health and 

safety data. 

In addition to limiting public access, information sharing across EPA offices is 

often constrained by the TSCA CBI protections. Hard copies of CBI documents 

are housed at the CBI Center at EPA Headquarters. Some CBI information is 

available on OPPT’s CBI Local Area Network, but it is only accessible to staff 

that deal directly with the PMN and Section 8(e) notice reviews. Sharing CBI 

with other EPA staff is a time- and labor-intensive process, because CBI must be 

handled in a secured manner in accordance with the TSCA CBI Protection 

Manual. Despite other national security clearance procedures, only individuals 

who have undergone CBI security training and have been granted clearance from 

OPPT may access CBI. 

PMN Fees Do Not Defray EPA’s Costs 

TSCA authorizes EPA to charge a fee to businesses submitting a PMN 

application. The fee is intended to defray the cost of EPA’s review under the 

New Chemicals Program. Currently, the fees collected from manufacturers and 

importers do not reflect actual costs. In 1988, the fee rule went into effect at 

$2,500 maximum, and it remains unchanged. For the past 5 years, fees collected 

by EPA for PMN reviews have amounted to approximately 11 percent of its costs 

(Table 2-1). Moreover, the monies collected are not directly used to fund EPA’s 

review. Collected fees are deposited into the general Treasury and are not 

directed to the review program or even EPA. 

Table 2-1: PMN Program Budget and Fees, Fiscal Years 2004-2008 

FY2004 FY2005 FY2006 FY2007 FY2008 

PMN Budget $12,166,700 $12,435,700 12,879,200 12,416,400 12,654,300 

Fees Collected $1,300,000 $1,390,000 $1,360,000 $1,290,000 $1,320,000 

Percent 10.7 11.2 10.6 10.4 10.4 

Defrayed 

Source: EPA. 

Every year since FY 2001, EPA has sought permission to lift the maximum fee 

amount, but Congress has not approved an increase. The 2010 President’s Budget 

proposes to eliminate the $2,500 cap on the fee, which EPA estimates would 

bring in an additional $4 million. An elimination of the fee cap would defray 

about 40 percent of the review cost. This proposal is consistent with government12 
 

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wide efforts to appropriately align program costs to those who benefit directly 

from such services. Of note is that EPA initially drafted a proposal to raise the 

cap to $12,500, not eliminate it completely. Also not mentioned in the published 

budget is the EPA proposal to establish a separate account within the Treasury for 

the PMN fees collected. This account would be accessible to the review program 

to defray review costs, and would be in line with the statute’s intent. 

Measures Do Not Reflect Performance 

TSCA performance measures for prevention and compliance are deficient. 

OPPT’s and OECA’s respective performance measures for managing risks from 

new chemicals do not accurately reflect program performance in preventing risk 

or in assuring compliance. In cases where full information does not exist or 

analyses are limited, OPPT reports the new chemicals as not having risk, while 

the limitations in the measure are not disclosed. OECA’s performance measure is 

not outcome based; rather, the measure tracks program activities. 

Assurance of Protection from New Chemicals Overstated 

EPA’s New Chemicals Performance Measure: Percentage of new Program seeks to prevent any chemicals or organisms introduced into new chemical from entering commerce that do not pose unreasonable into commerce that poses an risks to workers, consumers, or the unreasonable risk. EPA’s environment. Target: 100 percent assessment of whether this 

objective has been met is based 

on self-disclosures from chemical manufactures and importers. OPPT’s 

performance measure is calculated by comparing the risks identified on Section 

8(e) notices received in the fiscal year to previously reviewed PMNs. The intent 

of the comparison is to measure present-day performance of the PMN review 

process. The question answered during the calculation of the measure is “what 

would the program conclude if it received the same chemical information 

[submitted and reviewed as a PMN] today?” If the risk identified in a Section 

8(e) notice would not be correctly identified and mitigated by the review, then 

according to OPPT, it has failed to meet its target percentage. For FY 2005 and 

FY 2006, OPPT reported to Congress and the public that 100 percent of chemicals 

introduced into commerce did not pose any unreasonable risks. In FY 2007, it 

identified one failure resulting in a report of 96 percent success. 

EPA receives approximately 300 Section 8(e) notices annually. Of those 300, 

approximately 30 are applicable to chemicals that had undergone the PMN 

review process. The applicable Section 8(e) notices may relate to chemicals that 

underwent PMN review as many as 20 years ago. Therefore, the notices do not 

necessarily relate to chemicals being introduced into commerce in the current 

year. While industry is required to submit these notices for any potentially 

unreasonable risks identified, industry is not required to conduct any regular 

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testing. Moreover, the measure does not include risks identified in scientific 

studies conducted by other organizations or through EPA’s own data collection 

efforts; information from these sources is not required to be submitted through 

Section 8(e) notices. 

Due to the allocation of limited resources to oversight activities, as discussed in 

the oversight limitations section of this report, EPA does not have assurance that 

industry submits all Section 8(e) notices for identified risks. One such example 

is the Agency’s settlement with E. I. du Pont Nemours in 2005 resulting in a 

$10.5 million penalty – the largest EPA settlement under the TSCA statute. 

EPA’s monitoring did not uncover the industry failure to inform EPA of newly 

identified risk. Rather, an attorney working on a class action suit on behalf of the 

citizens of Ohio and West Virginia brought this information to EPA in 2001. 

EPA issued a press release on July 8, 2004, and announced that OECA filed an 

administrative action against the company for two violations of TSCA Section 

8(e). The press release stated, “The violations consist of multiple failures to 

report information to EPA about substantial risk of injury to human health or the 

environment from a chemical during a period beginning in June 1981 through 

March of 2001.” 

OECA inspectors emphasize assistance and oversight of smaller establishments, 

unlike DuPont, with the assumption that the larger companies are more likely to 

be cognizant of the regulations and more capable and inclined to comply. 

Core TSCA OECA Performance Measures 

In EPA’s annual reports, OECA reported the number of inspections conducted, 

violations found, and fines issued for Core TSCA as results of performance rather 

than the amount of risk prevented or compliance assured. OECA does not report 

any other performance measure for Core TSCA. 

OECA reports the number of inspections conducted as a measure of compliance 

success. This measurement method is insufficient for several reasons. First, it 

does not demonstrate that OECA’s monitoring and enforcement activities are 

helping EPA prevent risk from toxic chemicals. Second, TSCA inspections are 

few in number compared with the estimated size of the universe of manufacturers 

and importers. Third, inspections are not strategically selected to cover a 

meaningful cross-section of the universe, and OECA has not provided a consistent 

targeting scheme to be used across regions. 

Conclusions 

EPA lacks a coordinated process for ensuring risk mitigation from new 

chemicals. OPPT and OECA need a coordinated, consistent, and strategically 

designed approach to Core TSCA implementation and enforcement. EPA cannot 

provide assurance that that all risks from new chemicals are regulated and that 

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the restrictions are followed by industry. While OPPT invests many resources in 

the review and regulation of new chemicals, OECA views TSCA as a low 

enforcement priority. Lack of consistency in procedures for information and 

priority sharing between OPPT, OECA, and regions has reduced effectiveness 

and efficiency by limiting access to necessary shared information. OECA has not 

instituted a nationwide strategy to maximize compliance assurance in a way that 

effectively uses its limited resources. Further, the lack of a collective EPA 

strategy for Core TSCA oversight and regulation can result in less effective risk 

mitigation and reduced public confidence. 

Recommendations 

We recommend that the Deputy Administrator: 

2-1 Link the execution of OPPT’s New Chemicals Program with OECA’s 

Core TSCA program, establishing areas of mutual responsibility for 

managing new chemical risks. 

2-2 Link the TSCA goals of OPPT and OECA and devise performance 

measures that ensure accountability of each office, while demonstrating 

EPA’s overall assurance of meeting the objectives of TSCA. 

2-3 Request statutory authority to increase PMN fees to recover PMN review 

costs with justification for lifting the fee cap without a new fee limit, or to 

establish a new fee limit to defray the review costs. 

We recommend that the Assistant Administrator for Prevention, Pesticides, and 

Toxic Substances: 

2-4 Establish criteria and procedures outlining what chemicals or classes of 

chemicals will undergo risk assessments for low-level and cumulative 

exposure. Periodically update and revise risk assessment tools and models 

with latest research and technology developments. 

2-5	 Develop a more detailed TSCA CBI classification guide that provides 

criteria for approving CBI coverage and establishes a time limit for all 

CBI requests to allow for eventual public access to health and safety data 

for chemicals. 

We recommend that the Assistant Administrator for Enforcement and Compliance 

Assurance: 

2-6 Develop a management plan for Core TSCA enforcement and 

compliance processes, including: 

a.	 Regularly scheduled Core TSCA education and training of OECA and 

OPPT personnel. 

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b. 

c. 

Consistent enforcement strategies across regions for monitoring and 

inspection protocols. 

Periodic assessment and evaluations of techniques and strategies 

employed. 

2-7 Ensure the planned enforcement strategies meet the objectives of TSCA 

while maximizing resources across regions and leveraging input from 

OPPT technical experts. 

2-8 Develop a methodology to create and periodically update a list of known 

regulated entities. For unknown regulated entities or nonfilers, develop a 

profile of entities of interest for use by inspectors, as well as OPPT 

personnel. 

Agency Comments and OIG Evaluation 

The Agency concurred with our recommendations and agreed to implement them. 

It stated that TSCA authority is outdated and does not provide EPA with the tools 

to adequately protect human health and the environment. In September 2009, the 

Administrator announced a set of core principles to strengthen U.S. chemical 

management laws and in January 2010, listed, “assuring the safety of chemicals” 

as one of seven EPA priorities. The Agency commented that legislative reform of 

TSCA may take time and it will utilize its current authority to the fullest extent in 

the meantime. 

Our recommendations are intended to result in more effective coordination of risk 

assessment, oversight, and enforcement activities for TSCA-regulated chemicals. 

In addition, the Agency’s overall assurance of meeting the objective and intent of 

TSCA should be more accurately reflected in performance measures and public 

reports. The Agency has already started to take actions that will address our 

recommendations and there is potential to integrate new tools and authorities as 

they become available. The recommendations are open pending completion of 

corrective actions. 

The Agency’s complete response is included in Appendix B. 

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Status of Recommendations and 

Potential Monetary Benefits 

POTENTIAL MONETARY 

RECOMMENDATIONS BENEFITS (in $000s) 

Planned 

Rec. Page Completion Claimed Agreed To 

No. No. Subject Status1 Action Official Date Amount Amount 

2-1 15 Link the execution of OPPT’s New Chemicals O 

Program with OECA’s Core TSCA program, 

establishing areas of mutual responsibility for 

managing new chemical risks. 

2-2 15 Link the TSCA goals of OPPT and OECA and O 

devise performance measures that ensure 

accountability of each office, while demonstrating 

EPA’s overall assurance of meeting the objectives 

of TSCA. 

2-3 15 Request statutory authority to increase PMN fees O 

to recover PMN review costs with justification for 

lifting the fee cap without a new fee limit, or to 

establish a new fee limit to defray the review costs. 

2-4 15 Establish criteria and procedures outlining what O 

chemicals or classes of chemicals will undergo risk 

assessments for low-level and cumulative 

exposure. Periodically update and revise risk 

assessment tools and models with latest research 

and technology developments. 

2-5 15 Develop a more detailed TSCA CBI classification O 

guide that provides criteria for approving CBI 

coverage and establishes a time limit for all CBI 

requests to allow for eventual public access to 

health and safety data for chemicals. 

2-6 15 Develop a management plan for Core TSCA O 

enforcement and compliance processes, including: 

a. Regularly scheduled Core TSCA education 

and training of OECA and OPPT personnel. 

b. Consistent enforcement strategies across 

regions for monitoring and inspection 

protocols. 

c. Periodic assessment and evaluations of 

techniques and strategies employed. 

2-7 16 Ensure the planned enforcement strategies meet O 

the objectives of TSCA while maximizing resources 

across regions and leveraging input from OPPT 

technical experts. 

2-8 16 Develop a methodology to create and periodically O 

update a list of known regulated entities. For 

unknown regulated entities or nonfilers, develop a 

profile of entities of interest for use by inspectors, 

as well as OPPT personnel. 

Deputy Administrator 

Deputy Administrator 

Deputy Administrator 

Assistant Administrator for 

Prevention, Pesticides, and 

Toxic Substances 

Assistant Administrator for 

Prevention, Pesticides, and 

Toxic Substances 

Assistant Administrator for 

Enforcement and 

Compliance Assurance 

Assistant Administrator for 

Enforcement and 

Compliance Assurance 

Assistant Administrator for 

Enforcement and 

Compliance Assurance 

 O = recommendation is open with agreed-to corrective actions pending 

 C = recommendation is closed with all agreed-to actions completed 

 U = recommendation is undecided with resolution efforts in progress 

17 

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Appendix A 

New Chemicals Program Logic Model 

This conceptual logic model for the New Chemicals Program illustrates the interrelated responsibilities 

among industry, OPPT, and OECA in meeting TSCA objectives. The logic model shows how the 

coordinated long-term outcomes of the three can contribute to the meeting of EPA’s long-term goal. 

Source: OIG analysis. 

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Appendix B 

Agency Comments on Draft Report 

(Received on January 15, 2010) 

MEMORANDUM 

SUBJECT: Draft Evaluation Report: EPA Needs a Coordinated Plan to Oversee Its Toxic 

Substances Control Act Responsibilities 

FROM: Bob Perciaseppe 

Deputy Administrator 

TO: Jeffrey Harris 

Director for Program Evaluation, Cross-Media Issues 

Thank you for providing the opportunity to review the draft evaluation report: EPA 

Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities. We 

appreciate and concur with OIG’s recommendations. This memorandum includes the corrective 

actions the Agency commits to take in response to the recommendations, as well as planned 

completion dates for each action. 

We note that OIG acknowledged in their report the limitations regarding the Agency’s 

authority to regulate chemicals under the Toxic Substances Control Act (TSCA). It is true that 

TSCA authority is outdated and does not provide the tools to adequately protect human health 

and the environment as the American people expect, demand and deserve. As stated by 

Administrator Lisa Jackson in her testimony before the U.S. Senate Committee on Environment 

and Public Works about chemical management reform, the time has come to bring TSCA into 

the 21st century. 

TSCA was signed into law in 1976 and was intended to provide protection of health and 

the environment against risks posed by chemicals in commerce. However, when TSCA was 

enacted, it authorized manufacture and use, without any evaluation, of all chemicals that were 

produced for commercial purposes in 1976 or earlier years. Thus, manufacturers of these 

“grandfathered” chemicals were not required to develop and produce data on toxicity and 

exposure that are needed to properly and fully assess potential risks. Further compounding this 

problem, the statute never provided adequate authority for EPA to evaluate existing chemicals as 

new concerns arose or as new scientific information became available. 

TSCA does provide some authority to EPA to mandate industry to conduct testing, but 

even in these cases it has taken years to obtain data and information. As a result, there are large, 

troubling gaps in the available data and state of knowledge on many widely used chemicals in 

commerce. As OIG’s report acknowledges, TSCA also does not place any legal obligation on 

producers to conduct testing on new chemicals being introduced into commerce. They are 

required only to supply existing data to EPA and are not required to provide all the data 

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necessary to fully assess a chemical’s risks. The Agency should have the necessary tools to 

quickly and efficiently require testing, or obtain other information from manufacturers that is 

relevant to determining the safety of chemicals, without delays and obstacles currently in place, 

or excessive claims of confidential business information. All of this must happen with 

transparency and concern for the public’s right to know. 

In addition, we believe it is also important to evaluate TSCA enforcement with a clear 

understanding of the statutory and regulatory framework. Enforcement of Core TSCA is critical 

to ensuring environmental protection, but TSCA lacks the broad information-gathering and 

enforcement provisions equivalent to other major environmental protection statutes. For 

example, TSCA lacks the administrative authority to seek injunctive relief, issue administrative 

orders, collect samples, and quarantine and release chemical stocks, among other key authorities. 

For these reasons and others, there is a compelling case that TSCA must be updated and 

strengthened. The following are the Administration’s core principles to strengthen U.S. 

chemical management laws as announced by Administrator Jackson on September 29, 2009: 

•	 Chemicals should be reviewed against safety standards that are based on sound 

science and reflect risk-based criteria protective of human health and the 

environment. 

•	 Manufacturers should provide EPA with the necessary information to conclude that 

new and existing chemicals are safe and do not endanger public health or the 

environment. 

•	 Risk management decisions should take into account sensitive subpopulations, cost, 

availability of substitutes and other relevant considerations. 

•	 Manufacturers and EPA should assess and act on priority chemicals, both existing 

and new, in a timely manner. 

•	 Green chemistry should be encouraged and provisions assuring transparency and 

public access to information should be strengthened. 

•	 EPA should be given a sustained source of funding for implementation. 

Because legislative reform may take time, the Agency will utilize the current authority 

under TSCA to the fullest extent to protect the American people and the environment from 

dangerous chemicals. The recommendations contained in your report are consistent with the 

Agency’s approach to effectively manage chemicals and we accept them. In accordance with 

EPA Manual 2750, below are responses for each recommendation contained in the OIG report. 

Response to Specific Recommendations 

The report recommends that the Deputy Administrator: 

2-1 Link the execution of OPPT’s New Chemicals Program with OECA’s Core TSCA 

program, establishing areas of mutual responsibility for managing new chemical 

risks. 

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The Agency accepts this recommendation. OPPTS and OECA share responsibility for 

managing chemical risks and have already implemented several activities to ensure better 

communication and coordination. Specifically, senior managers of OPPT and OECA 

began discussions in the summer of 2009 regarding fostering better coordination across 

all TSCA enforcement and programmatic activities (including the New Chemicals 

Program). At the senior leader level, the two offices agreed to conduct formal quarterly 

meetings between the Assistant Administrators for OPPTS and OECA; the first two such 

meetings occurred in October and December 2009. The Assistant Administrators for 

OPPTS and OECA have continued to meet on several occasions to discuss TSCA 

enforcement matters. 

Additionally, OPPTS and OECA conducted a national meeting in October with the 

Regions to discuss how to better coordinate our mutual responsibilities and to help 

identify priorities for 2011. Finally, OPPTS and OECA have also begun development of 

a document that enhances collaboration between the two offices and establishes clear 

areas of responsibility. The document is intended to provide structure for collaboration 

between the two offices to maximize the efforts to achieve the shared strategic goals of 

protecting public health and the environment by reducing risks. The target date for 

finalizing the document is June 30, 2010. Finally, at the staff level, greater collaboration 

between the offices is already taking place in the area of sharing information and 

developing focus areas. One example of this collaboration is an agreement to initiate a 

joint project in the 2nd quarter of FY 2010 to develop the criteria and supporting data 

needed to target for compliance inspection certain regulated facilities subject to New 

Chemical Significant New Use Rules (SNURs) and Low Volume Exemptions. 

2-2 Link the TSCA goals of OPPT and OECA and devise performance measures that 

ensure accountability of each office, while demonstrating EPA’s overall assurance of 

meeting the objectives of TSCA. 

The Agency accepts this recommendation to devise related measures that ensure 

accountability yet reflect the separate functions of each office. As a first step, OPPTS and 

OECA will coordinate in the development of their respective National Program Managers 

(NPM) guidance. The NPM guidance establishes programmatic priorities and 

implementation strategies for the respective offices. An integral part of the NPM process 

is the development of the Annual Commitment System (ACS) accomplishments. The ACS 

is the central repository of Agency performance measurements. OPPTS and OECA will 

work to coordinate performance measures in the 2011 NPM and ACS processes. The 

draft NPM guidance is due to OCFO by February 12, 2010, the final guidance will be 

issued by OCFO on April 23, 2010 and full implementation will begin on October 1, 

2010. 

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2-3 Request statutory authority to increase PMN fees to recover PMN review costs with 

justification for lifting the fee cap without a fee limit, or to establish a new fee limit 

to defray the review costs. 

The Agency accepts this recommendation and has already taken steps to address the 

issue. In fact, the Agency has included in its President's Budget submissions since 1999 

language to increase the PMN fees. Note that the U.S. Department of the Treasury 

collects the fees for the PMN program; they are not received by the Office of Prevention, 

Pesticides and Toxic Substances to recover PMN review costs. Moreover, as discussion 

of TSCA reform continues, we would like to highlight Administrator Jackson’s core 

principal of giving EPA a sustained source of funding for implementation. 

We recommend that the Assistant Administrator for Prevention, Pesticides and Toxic 

Substances (OPPTS): 

2-4 Establish criteria and procedures outlining what chemicals or classes of chemicals 

will undergo risk assessments for low-level and cumulative exposure. Periodically 

update and revise risk assessment tools and models with latest research and 

technology developments. 

OPPTS agrees with this recommendation, and recognizes the need to conduct cumulative 

risk assessments where appropriate. Such an assessment requires an understanding of the 

mode of action of the chemical or class of chemicals, and an understanding of common 

exposure pathways. Developing a better understanding of cumulative risk is a high 

priority of the Agency’s science agenda. Under the authorities currently granted by 

TSCA, this level of understanding is not generally available for most PMNs in the New 

Chemicals Program. However, this information is available for some classes of 

chemicals in the Existing Chemicals Program; assessments of these chemical classes can 

inform the New Chemicals program when PMNs for similar chemicals are submitted. As 

stated in Administrator Jackson’s principles for TSCA Reform, manufacturers should 

provide EPA with the necessary information to conclude that new and existing chemicals 

are safe and do not endanger public health or the environment. 

To this end, OPPT is initiating cumulative assessments of eight phthalates as outlined in 

the Action Plan release on December 30, 2009. EPA intends to lay the groundwork to 

consider initiating rulemaking under TSCA Section 6(a) to regulate the eight phthalates 

in 2012. In preparation for the rulemaking, EPA intends, in cooperation with the U.S. 

Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug 

Administration (FDA), to continue to work to fully assess the use, exposure and 

substitutes for these chemicals. In its further review, EPA plans to consider the future 

results of the cumulative assessment that will be developed by the CPSC. The 

cumulative assessment approach under development by CPSC, which may be completed 

in 2012, as well as the ongoing review of phthalates at the FDA and the assessment for 

EPA’s IRIS program, are due to be completed in 2012. 

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In addition, with regard to the recommendation that the Office periodically update and 

revise risk assessment tools and models with latest research and technology 

developments, OPPTS agrees with this recommendation, and, in fact, does this on a 

routine basis. OPPT will report on progress on November 1, 2010. 

2-5	 Develop a more detailed CBI classification guide that provides criteria for 

approving CBI coverage and establishes a time limit for all CBI requests to allow 

for eventual public access to health and safety data for chemicals. 

OPPTS accepts this recommendation. As stated in one of the Administration’s core 

principles for TSCA reform, public access to information should be strengthened. The 

Agency is committed to transparency and believes that the public right to know about the 

hazards of chemicals is integral to sound chemical management practices. Since the 

summer of 2009, OPPTS has been making important strides in this area. In July 2009, 

OPPTS published notice that the Agency was shifting 530 chemicals from the non-public 

to the public portion of the TSCA Inventory. Another example is the new initiative to 

addess CBI claims in TSCA Notices of Substantial Risk (TSCA Section 8(e) filings). In 

early 2010 OPPTS will publish a Federal Register Notice that will inform chemical 

companies that they may not claim chemical identify as CBI in an 8(e) submission when 

the substance is listed on the public portion of the TSCA inventory. These efforts and 

others will be part of a multi-faceted approach, which will include periodic but systematic 

review of CBI claims made in TSCA filings classified as containing health and safety 

data. 

It should be noted, the criteria for making CBI claims for TSCA are located generally at 

40 CFR 2.208 and 2.306 but there are also TSCA rule specific regulations that provide 

criteria as well. 

We recommend that the Assistant Administrator for Enforcement and Compliance 

Assurance (OECA): 

2-6	 Develop a management plan for Core TSCA enforcement and compliance processes 

including: 

a.	 Regularly scheduled Core TSCA education and training of OECA and OPPT 

personnel. 

b.	 Consistent enforcement strategies across regions for monitoring and 

inspection protocols. 

c.	 Periodic assessment and evaluation of techniques and strategies employed. 

The Agency concurs with the recommendation that a plan be developed that includes 

training and education as well as the development of consistent national enforcement 

strategies and periodic assessment. We have made significant progress to address this 

recommendation. Specifically, OECA is working with OPPTS and the Regions to 

develop a TSCA Compliance Monitoring Strategy (CMS). The CMS is a plan to 

maximize available resources and develop consistent enforcement strategies across all of 

TSCA. A draft CMS document has been developed and is currently being reviewed by a 

Headquarters and Regional workgroup. Because the CMS covers all of TSCA and not 

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just the sections reviewed by the OIG, it is anticipated that drafting of the CMS will 

continue through the spring of 2010. 

OECA is also currently revising the February 2003 Core TSCA Operations Manual and 

Inspection Manual to ensure the most current techniques and approaches are used to meet 

the objectives of TSCA. A regional workgroup is currently reviewing the first draft of 

both the operations and inspection manuals and comments are due to OECA by January 

29, 2010. 

Also, OECA will work with OPPTS to explore the development of a Core TSCA national 

meeting beginning in FY2011. The purpose of this meeting will be to provide training on 

current inspection and enforcement techniques as well as highlight best practices. 

2-7	 Ensure the planned enforcement strategies meet the objectives of TSCA while 

maximizing resources across regions and leveraging input from OPPT technical 

experts. 

The Agency concurs with the recommendation that enforcement strategies align with the 

objectives of TSCA, that we maximize resources and leverage input from OPPT. OECA 

and OPPTS believe that quarterly meetings at the Assistant Administrator level, a 

coordinated NPM and ACS process, a CMS and revised operations and inspection 

manuals will address the concerns identified in this recommendation. Specific actions and 

dates are included in other responses to recommendations found in this document. 

2-8	 Develop a methodology to create and periodically update a list of known regulated 

entities. For unknown regulated entities or nonfilers, develop a profile of entities of 

interest for use by inspectors, as well as OPPT personnel. 

The Agency concurs with the recommendation and agrees that enforcement could be 

enhanced with a targeted list of facilities. It is important to note that neither the TSCA 

statute nor the regulations require companies to notify EPA they are in the business of 

manufacturing, importing, or using chemicals. By introducing a new chemical into 

commerce, any facility could become newly regulated. As a consequence, OECA and 

OPPTS do not have complete and accurate information on the universe of regulated 

entities. However, OPPTS has recently made significant progress in integrating 

regulatory data systems and by early 2010 will integrate over 6,300 TSCA facility 

records with EPA’s facility registry system (FRS). As more of the Agency’s data 

systems become integrated, EPA’s ability to define the universe will steadily improve. 

Finally, OPPTS and OECA will work together to identify a profile of potential targets 

within the universe of regulated entities in the revision to the Core TSCA Operations 

Manual. 

Again, we appreciate the opportunity to review and comment on this draft report. Should you 

have any questions or concerns regarding this response, please contact Megan Carroll in OPPTS 

at 202-564-2814 or Rosemarie Kelley in OECA at 202-564-4014. 

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Appendix C 

Distribution 

Office of the Administrator 

Deputy Administrator 

Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances 

Assistant Administrator, Office of Enforcement and Compliance Assurance 

Agency Follow-up Official (the CFO) 

Agency Follow-up Coordinator 

General Counsel 

Associate Administrator for Congressional and Intergovernmental Relations 

Associate Administrator for Public Affairs 

Audit Follow-up Coordinator, Office of the Administrator 

Audit Follow-up Coordinator, Office of Prevention, Pesticides, and Toxic Substances 

Audit Follow-up Coordinator, Office of Enforcement and Compliance Assurance 

Acting Inspector General 

25