to Produce

Assessments and

Implement the Toxic

Substances Control

Act

United States Government Accountability Office

GAO incorporated as appropriate.

can have negative health and environmental consequences. EPA’s ability

to effectively implement its mission of protecting public health and the

environment depends on its credible and timely assessments of the risks

posed by chemicals. The agency’s Integrated Risk Information System

(IRIS) Program identifies and characterizes the health hazards of

chemicals and produces chemical assessments that contain this

information. Several program and regional offices at EPA use these

chemical assessments in their statutorily mandated risk management

The Toxic Substances Control Act of 1976 (TSCA) provides EPA with the

(Lautenberg Act), which amended TSCA to expand EPA’s authority and

responsibility related to regulating toxic chemicals, and established

response to NAS’s and our recommendations, the IRIS Program began

making changes designed to increase transparency about the program’s

processes and methodologies, increase the use of a systematic review

process,

and modernize information collection. In addition, we previously

recommended that EPA develop an agency-wide chemical management

strategy to address the unmet needs of EPA program offices and

This area was

added to the High-Risk List as a government program in need of broad-

based transformation. While several areas of EPA carry out chemical risk

assessments, this report focuses on the IRIS Program and EPA’s

implementation of TSCA, as amended.

assessments and (2) the extent to which EPA has demonstrated

remain.

To describe the extent to which the IRIS Program has addressed

identified challenges and made progress toward producing chemical

assessments, we interviewed IRIS officials, including leadership and staff,

and leadership in EPA’s National Center for Environmental Assessment,

which manages the IRIS Program. We also interviewed the leadership (as

of September 2018) in EPA’s Office of Research and Development

(ORD) and officials from EPA program and regional offices that request or

from our prior work with the IRIS Program. In addition, we obtained

program documentation from 2012 through 2019 from IRIS officials and

through our own searches of EPA’s website on changes to IRIS Program

management practices, use of new tools and techniques, and timelines

for the development of chemical assessments. We reviewed applicable

EPA guidelines and program management practices, including the lean

management system being implemented at EPA.

We also compared

EPA’s actions to establish priorities with federal standards for internal

in the Risk Assessment Division—responsible for risk assessment. In the

groups organized by discipline that bring together experts from across

OPPT branches. To gain perspective from outside stakeholder

organizations with interests in EPA’s chemical management strategies, in

addition to the two stakeholder organizations we identified above, we also

interviewed additional representatives from one environmental

stakeholder organization that have followed EPA’s implementation of

TSCA and one industry stakeholder organization that represents

companies affected by changes to TSCA. Our interviews with stakeholder

organizations were designed to collect anecdotal information rather than

resources associated with OPPT and EPA’s cost estimates for TSCA

implementation.

We conducted this performance audit from March 2018 to March 2019 in

accordance with generally accepted government auditing standards.

Those standards require that we plan and perform the audit to obtain

According to EPA, risk assessments provide information on potential

health or ecological risks.

Information from risk assessments, in

combination with other information, provides the basis for risk

management actions, as illustrated in the risk assessment model in figure

1.

Division uses those risk assessments to prepare risk management plans

Prior to 2016, environmental and industry stakeholder organizations

expressed concern that public confidence was decreasing regarding the

safe use of chemicals in commerce and that federal oversight should be

strengthened. For example, according to an American Bar Association

new TSCA guide,

the desire for reform was driven by a proliferation of

chemicals.

In June 2016, Congress passed the Lautenberg Act, which amended

TSCA in several ways. Table 1 summarizes some of the major changes

in the act, along with the purpose and application of TSCA’s major

sections.

on what conditions of use EPA must consider in a chemical risk

other areas such as the methodologies EPA uses in its systematic review

approach, the extent to which companies’ data are exempt from

disclosure, and the extent to which the fees rule accurately reflects EPA’s

costs for implementing TSCA. Some of these issues have resulted in

litigation.

The IRIS Program has addressed many process challenges, such as by

making changes to address the length of time it takes to develop

assessments and the level of transparency in how the program prepared

assessments. The program has made some progress since the beginning

assessment-related documents. These changes were made in response

to program implementation challenges identified by governmental,

industry, academic, and non-governmental stakeholders in recent years.

For example, in its 2011 report, NAS identified timeliness and

transparency as issues.

Developing IRIS assessments has historically been a lengthy process.

Because of the rigor of the IRIS process and the amount of literature that

program staff must search and consider, producing an assessment

typically takes several years, as we found in December 2011.

length of time it takes for the IRIS Program to complete its assessments,

they prefer these assessments as sources of information over other

agencies’ toxicity assessments.

To address the length of time it takes to produce assessments, the IRIS

Program is (1) employing project management principles and specialized

software that enable the program to better plan assessment schedules

products that address specific agency needs;

peer review process as much as possible.

The first way in which the IRIS Program is addressing the length of time it

takes to produce assessments is by utilizing project management

principles and new software that enable the program to better plan

assessment schedules and utilize staff. IRIS officials said that by using

process track and resolve screening conflicts.

Additionally, an official from EPA’s National Health and Environmental

Effects Research Laboratory said that the laboratory uses a similar

screening process. The laboratory worked with the IRIS Program to

identify similar constructs in their processes and used each other’s results

to make changes and validate tools used by both. According to IRIS

officials, as a result, the use of these tools has created more efficient

workflow processes, leading to considerable cost and time savings. The

incorporation of systematic review software tools has greatly helped the

program more efficiently carry out tasks like screening literature,

wide-ranging assessment, the program can produce assessments that

office needs, reducing the amount of time IRIS staff needed to search for

information, synthesize it and draft, review, and issue an assessment. For

example, if the Office of Air and Radiation needed a chemical

assessment that examined only inhalation exposures, the IRIS Program

could limit its assessment to a single exposure pathway, which would

reduce the amount of data that staff review and extract and, with less text

to draft and less complex peer reviews, allow the assessment to more

quickly move through the process.

An assessment on perfluorobutane sulfonic acid (PFBS) was also

consensus on their reviews. As a result, SAB and NAS peer reviews can

produce more fit-for-purpose assessments that are smaller in scope, they

plan to utilize letter reviews as appropriate, to streamline the peer review

process. IRIS Program officials said they also hope that other changes

they recently implemented—primarily, increased transparency and

systematic review—will help speed up the peer review process by

producing a higher-quality overall draft.

Another major category of NAS recommendations that the IRIS Program

has addressed is the need for greater transparency in how the program

review, which provides a structured and transparent process for

identifying relevant studies, reviewing their methodological strengths and

weaknesses, and integrating these studies as part of a weight of evidence

analysis, and (2) increased outreach efforts with stakeholders and the

public, both in terms of the frequency and the depth of content about

assessment preparation.

investigation that focuses on a specific question and uses explicit,

prespecified scientific methods to identify, select, assess, and summarize

the findings of similar but separate studies. The goal of systematic review

methods is to ensure that the review is complete, unbiased, reproducible,

and transparent. By using systematic review, the IRIS Program can

demonstrate that it considered all available literature in forming

conclusions and deriving toxicity values. Utilizing the new software tools

described above allows program staff to search more widely than before

and to identify the most relevant results faster and more accurately. The

Additionally, new software allows the IRIS Program to save and publish

others for review and inclusion. The software also allows multiple staff to

check searches and concur or not-concur with the initial assessment

about including a scientific article in the draft assessment. IRIS officials

told us that the transparency associated with systematic review and

clearer explanation of methodologies in assessments (as well as

releasing subsidiary documents, such as IRIS Assessment Plans and

Assessment Protocols) will improve stakeholders’ understanding of how

the program arrives at its conclusions.

when to expect assessments, as well as what those assessments will

cover. To prepare the 2015 Multi-Year Agenda, the IRIS Program

December 2015.

When new leadership joined the IRIS Program in early

2017, the new officials began reaching out to individual program and

regional offices to re-confirm their needs and priorities. IRIS officials said

this effort was in part to ensure that the IRIS Program was delivering what

the program offices needed, as well as to help the IRIS Program keep its

priorities up to date and ensure that resources (primarily staff) were

updated list of assessments that were being developed with anticipated

known together as the Framework Rules. EPA responded to the 1-year

deadlines to establish three of the four Framework Rules.

These three

rules are

group told us that, while EPA has met a number of major statutory

deadlines, the agency’s rules and other actions do not reflect the best

available science and are contrary to both the letter and intent of the new

and the agency continues to meet important deadlines required by the

utilizing the best available science and a weight of the evidence approach

to make high quality chemical management decisions. Representatives

from industry stakeholder organizations we interviewed told us they

believe the rules are consistent with TSCA, but that EPA is not

consistently meeting the 90-day deadline to make determinations on new

chemicals or the 30-day deadline to make determinations on low-volume

exemptions.

EPA faces challenges with its ability to implement TSCA, such as

managing the risk posed by ongoing litigation, ensuring appropriate

resources, developing guidance documents to ensure consistency, and

Specifically, the environmental

EPA and chemical industry intervenors respond by

devote additional resources to implement the relevant provisions of

TSCA. For example, if the suit involving the risk evaluation rule is

successful, EPA may be forced to redo parts of its risk evaluations close

to the December 2019 deadline to finalize these evaluations. EPA is

required to complete its first 10 existing chemical evaluations not later

than 3 years after the date on which it initiated the risk evaluations, which

was December 2016. TSCA also allows for an extension of the risk

evaluation deadlines for up to 6 months if the agency deems it necessary.

The Lautenberg Act greatly increased OPPT’s workload. Prior to the

enactment of the Lautenberg Act, EPA did not have deadlines for

represents a tight deadline, according to EPA officials.

Furthermore, the

law requires EPA to ensure that 20 risk evaluations are ongoing for high-

priority substances 3-1/2 years after enactment and that at least 20

In addition, under TSCA prior to the Lautenberg Act, a new chemical

could enter commerce after 90 days unless EPA took action to the

contrary. Under the Lautenberg Act, EPA is required to make a

determination on a new chemical before it can be manufactured—another

source of increased workload.

Partially because of the increased workload, some OPPT officials told us

bring together experts from across OPPT branches. The Risk

Assessment Division is particularly affected by the heavy workload,

according to OPPT officials and representatives from an industry

hire 40 additional FTEs. As of October 2018, OPPT officials told us that

hire more employees. OPPT officials told us that reaching an appropriate

OPPT officials said they expect that the recently announced initiative to

have a positive impact on these efforts.

purchasers find products that perform and are safer for human health and