1. No category

At the Intersection of Health, Health Care and Policy
Cite this article as:
Sarah A. Vogel and Jody A. Roberts
Why The Toxic Substances Control Act Needs An Overhaul, And How To Strengthen
Oversight Of Chemicals In The Interim
Health Affairs, 30, no.5 (2011):898-905
doi: 10.1377/hlthaff.2011.0211
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Regulating Chemical Use
By Sarah A. Vogel and Jody A. Roberts
10.1377/hlthaff.2011.0211
HEALTH AFFAIRS 30,
NO. 5 (2011): 898–905
©2011 Project HOPE—
The People-to-People Health
Foundation, Inc.
doi:
Sarah A. Vogel (svogel@jffnd
.org) is a program officer at
the Johnson Family
Foundation, in New York City.
Jody A. Roberts is the
associate director of the
Center for Contemporary
History and Policy at the
Chemical Heritage Foundation,
in Philadelphia, Pennsylvania.
Why The Toxic Substances Control
Act Needs An Overhaul, And
How To Strengthen Oversight
Of Chemicals In The Interim
ABSTRACT The Toxic Substances Control Act gives the Environmental
Protection Agency (EPA) the authority to regulate industrial chemicals
not covered by other statutes. Today there are more than 83,000 such
chemicals. However, the law is widely perceived as weak and outdated,
and various stakeholders have called for its reform, citing the EPA’s
inability to regulate the use of asbestos, among other substances. We
analyze the flaws in the act and suggest ways in which the EPA might
better position itself to manage chemical risks and protect the public’s
health. In addition to the new tools and technologies it is adopting, the
agency needs new allies—both inside and outside the government—in its
efforts to identify and control hazardous chemicals.
I
n 1976, after five years of negotiation
and debate, President Gerald Ford
signed into law the Toxic Substances
Control Act. The last of the major environmental statutes of the 1970s, the act
gave the Environmental Protection Agency
(EPA)—which had been established six years earlier—the authority to regulate the safety of industrial chemicals, to protect the environment
and human health. Specifically, the act gave the
EPA authority to require reporting, testing, and
restrictions on chemical substances not covered
by other regulatory statutes.
Prior to the act’s enactment, the federal
government had conducted limited oversight
of chemicals through a patchwork of regulations
governing the safety of pesticides, specific hazards in air and water, and some chemicals in
food. Missing from this fractured system were
the tens of thousands of industrial chemicals
that did not fall under the jurisdiction of these
narrowly tailored statutes. Some examples of
chemicals covered under the Toxic Substances
Control Act are asbestos, benzene, formaldehyde, mercury, polychlorinated biphenyls
(PCBs), and polybrominated diphenyl ethers
(PBDEs).1
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When the Toxic Substances Control Act was
passed, the exact number of chemicals in production was unknown. Even the names of many
chemicals were not public knowledge, let alone
their properties, uses, and hazardous characteristics and how much of each chemical was being
produced annually. The 1976 act gave the EPA
the authority to obtain information from manufacturers on industrial chemicals, including data
on health and safety, production, and use. In
addition, the agency now had the authority to
control or restrict chemicals that posed what the
act called an “unreasonable risk of injury to
health or the environment.”
However, the EPA’s ability to obtain safety information and set regulatory standards as outlined under the Toxic Substances Control Act has
fallen far short of expectations. This is due to a
combination of limitations in the statute and a
series of events over the past thirty-five years,
including reductions in the EPA’s budget in the
1980s, changing political leadership and shifting
agency priorities, limited oversight by Congress,
and successful challenges by the chemical industry to limit the EPA’s authority.
To work around these obstacles, the EPA has
increasingly relied on voluntary programs and
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procedures such as the High Production Volume
Challenge Program,2 designed to encourage
chemical producers to provide the agency with
data.3 Over the years, the Toxic Substances Control Act itself has received negligible attention
from members of Congress, environmental advocates, and the public health community. The
act has never been substantially updated. As a
result, profound gaps in the most basic health
and hazard information about the vast majority
of commercial chemicals persist today.4–6
Since 2009, however, various stakeholders—
including the chemical industry, environmental
and public health advocates, and the EPA—have,
for the first time, all called for some reform of the
act.7–9 The push to amend the law is the result of a
combination of rising consumer concerns about
product safety; the implementation of a new
chemicals management program in the European Union, called Registration, Evaluation, Authorisation, and Restriction of Chemicals, or
REACH;10 and the passage of individual chemical
bans and creation of comprehensive chemicals
policy programs in some US states.11
Growing interest in chemicals policy in general among public health advocates, health care
providers, disease groups, and health insurance
companies can be attributed to an emerging scientific consensus that environmentally relevant
levels of industrial chemicals—concentrations
detectable in the ambient environment or the
human body—may present important risks for
chronic disease.12,13
This marks an important shift.When the Toxic
Substances Control Act became law, health concerns focused on chemicals as carcinogens,
mutagens, and teratogens—agents that cause
cancer, genetic mutations, and embryonic or fetal abnormalities, respectively. Now there are
increasing concerns about the effect of everyday
chemical exposures on a number of chronic
diseases.
Public interest advocates, industry representatives, and legislators are debating ways to improve the Toxic Substances Control Act, but it is
not clear that broad reforms will be made in the
near future. A promising development is that the
EPA is taking steps to integrate new tools and
scientific knowledge into its chemicals program.
We recommend some additional steps that could
be taken to support the EPA in its efforts to
protect the public’s health from chemical
threats, given the limitations of the Toxic Substances Control Act.
Intent And Scope Of The Act
The Toxic Substances Control Act gives the EPA
three major responsibilities: to gather informa-
tion on new and existing chemicals being manufactured in the United States; to collect and produce data for use in assessing the risks of
chemicals; and to properly control those chemicals deemed to present—in the words of the
act—an “unreasonable risk of injury to health
or the environment” through rule making that
includes restrictions, labeling, and bans.4
The EPA’s first task after the enactment of the
law was to create an inventory of all chemicals
already in commercial use. Although a handful of
them had become household names by the early
1970s, the scope and magnitude of chemical production was largely unknown. The initial inventory listed 62,000 chemicals in production. Today the number is greater than 83,000, but there
is no truly accurate count.3
New Chemicals For new chemicals, defined as
those substances entering production after the
EPA’s initial inventory, the Toxic Substances
Control Act requires producers to notify the
agency prior to manufacture by submitting a
“premanufacture notification.” As part of the
notification, manufacturers must provide the
agency with information on the new chemical’s
name, physical properties, and use, along with
any available data on its toxicity. However, the
act does not mandate any toxicity testing. The
EPA then has ninety days to decide whether or
not additional information is required before
allowing the chemical onto the market.
Initially, this provision was widely regarded as
the weakest aspect of the act because it did not
require enough information and gave the EPA so
little time to make a decision. Despite these concerns, however, the provision is considered by
some former EPA officials to be one of the
agency’s most effective programs. This effectiveness is attributed to the EPA’s investment in the
development of methods for assessing chemical
toxicity by comparing new chemicals to structurally analogous ones already in use.
Using these comparisons—known as structure-activity relationships—allows the agency
to evaluate hazards rapidly, even in the absence
of adequate data about new chemicals. Information obtained from the structure-activity relationships on the potentially hazardous properties of a substance can discourage manufacturers
from submitting notifications for chemicals that
may raise concern.3,14,15 Although this process
may help prevent chemicals of concern from
coming onto the market, the EPA has experienced a far greater challenge in pulling hazardous substances off the market.
Existing Chemicals The vast majority of
chemicals currently in commercial use fall in
the category of “existing chemicals,” those in
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came law. Section 6 of the act, which promulgates rules for regulating existing chemicals, includes no requirements for testing these chemicals. By default they are presumed to be safe, and
the burden of demonstrating an “unreasonable
risk” falls on the EPA. Before the agency can
issue a regulation applying to one of these chemicals, the act requires it to demonstrate that the
chemical “will present an unreasonable risk” and
that the proposed regulation uses the “least burdensome requirements.”4,11,16
The barriers to both assessing and managing
the risks posed by existing chemicals have
proven to be nearly insurmountable. As a result,
thirty-five years after the passage of the Toxic
Substances Control Act, there remains a profound gap in data about chemicals that pose a
public health risk, and a lack of action to reduce
that risk.
What Went Wrong
No single event, statutory clause, or implementation decision led to the current weakness of the
act. Instead, its inability to function as intended
results from a series of legal, organizational, and
political challenges.
The Data Trap With no safety testing required
for existing chemicals, the EPA is responsible for
obtaining data in order to assess their risks. Yet
the Toxic Substances Control Act puts the agency
in what has been described as a “Catch-22” situation when it seeks to require new testing. Before the EPA can test a chemical for risk, the
agency must demonstrate that the product poses
“unreasonable risk.”6 Given unavoidable uncertainties and gaps in data, the agency has frequently found it difficult to meet this requirement. Consequently, over the past three
decades the agency has issued few orders for
new tests of existing chemicals.17
Where adequate health and safety data do exist, the process for issuing regulations on
existing chemicals is extensive and laborious,
consuming considerable time and resources.
Furthermore, the Toxic Substances Control Act’s
requirement that the EPA show that its proposed
rule to restrict the use of a chemical is the “least
burdensome” also consumes time and resources.18 The agency’s failure to regulate asbestos is
clear proof of the unintended consequences of
these requirements.
The Case Of Asbestos The EPA decided to use
each of the major provisions and powers that the
Toxic Substances Control Act granted it, to better
understand the act’s capabilities and limitations.
The agency chose asbestos as its test case for
developing regulatory restrictions.19 It worked
on a risk assessment of asbestos for ten years,
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The barriers to
assessing and
managing the risks
posed by existing
chemicals have proven
to be nearly
insurmountable.
collecting thousands of pages of published studies and developing a robust and detailed analysis
of risk and the economic impacts of regulation.
The agency eventually issued a regulation that
would have banned almost all uses of asbestos.
Asbestos producers, already facing many expensive lawsuits, immediately challenged the regulation in court.20 The Fifth Circuit Court of Appeals ruled that the EPA had failed to meet the
Toxic Substances Control Act’s high burden of
proving with “substantial evidence” that an “unreasonable” risk existed and that the proposed
regulation, which would ban most uses, presented the “least burdensome” approach.21 The
act’s requirement of “substantial evidence” is a
higher evidentiary burden than the “arbitrary
and capricious” standard outlined in the Administrative Procedures Act of 1946 and used by most
federal agencies.
In choosing not to appeal the decision, the EPA
effectively surrendered its authority to develop
rules that would place even limited restrictions
on chemicals. According to the agency’s leadership at the time, staff morale plummeted after
the decision, particularly among those who had
worked on developing the asbestos regulation.22
E. Donald Elliott, general counsel to the EPA
under President George H.W. Bush, later remarked that the court’s decision was “a public
policy and public health disaster and should be
explicitly overruled by Congress.”23
Without the power to regulate even a welldefined hazard, the agency lost a crucial tool
for protecting public health. It turned instead
to what it could do with greater ease—namely,
develop alternative, largely voluntary programs
to collect and assess data, such as the High Production Volume Challenge Program.2
An Orphan Statute Some of the challenges
faced by the EPA in implementing the Toxic Substances Control Act might have been surmount-
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The EPA has taken
some important steps
to reassert its
authority under the
current statute.
able had there been proper government oversight and investment—in terms of political
power as well as finances—coupled with interest
on the part of the public. But few politicians were
interested in championing chemicals policy
while the powerful chemical industry consistently supported the status quo.24
In the absence of regular congressional hearings, the EPA was left without strong political
allies willing to hold it accountable for properly
implementing the Toxic Substances Control Act.
Public-interest groups, environmental organizations, and labor unions rapidly lost interest in
the subject after the act’s passage.1,25 And all of
this occurred in the context of internal
government scrutiny and resource cuts that
undermined the authority and morale of all
federal regulatory agencies.26
New Demands For Chemical Safety
And Reform
Pressure From Europe With the turn of the
twenty-first century came renewed attention to
chemical safety in the United States and Europe.
From 1999 to 2006 the members of the European
Parliament negotiated a comprehensive chemicals management program, REACH.10 As in the
United States, the vast majority of chemicals on
the European market had been presumed to be
safe, with no requirements for testing.
Applying what is called the “no data, no market” rule, REACH reverses this policy by requiring manufacturers to submit safety data for both
new and existing chemicals produced in or exported to Europe. Chemicals must be registered,
evaluated, and authorized for use by the European Chemicals Agency, an organization established under REACH. Because Europe is the largest market for chemicals in the world, the
implications of the new requirements have potentially enormous impacts on the global
market.27,28
State Legislative Actions As Europe negotiated a new chemicals management program,
state governments in the United States began
to take actions to limit the market for hazardous
chemicals and promote safer chemical production. From 2003 to 2010 state legislatures passed
seventy-one chemical safety laws aimed at restricting the use of specific chemicals in products, including lead in toys and bisphenol A (better known as BPA) in baby bottles.29 In addition,
California, Maine, and Washington passed
broad chemicals management laws. Public support for restrictions on the use of chemicals and
stricter safety standards comes not only from
environmental advocates but also from firefighters, nurses, physicians, and disease groups.
Also, some retailers are demanding greater
transparency in and availability of safety data.
Congressional Response In response to
growing political pressure from environmental
and public health advocacy organizations for reform of the Toxic Substances Control Act, Sen.
Frank Lautenberg (D-NJ)30 and Reps. Henry
Waxman (D-CA) and Bobby Rush (D-IL)31 introduced separate bills in Congress in 2010. Both
pieces of legislation attempt to address the problems of data collection, testing requirements,
and information disclosure. Most notably, both
bills would require manufacturers to submit
some safety data for both existing and new
chemicals.
However, the bills were both introduced at the
end of the congressional session and on the heels
of a contentious midterm election. Today, with a
deeply divided Congress, the prospects for legislative action are uncertain. In addition,
congressional attacks on the EPA’s budget are
now at the front line of a coordinated effort to
roll back environmental regulations.
Strengthening Chemicals Policy
Under Current Law
Despite the uncertain fate of reform efforts and
potential budgetary constraints, the EPA has
taken some important steps to reassert its authority under the current statute. Importantly,
these new actions are being bolstered by the incorporation of scientific and technological
breakthroughs.
Lisa P. Jackson, EPA administrator, launched
a comprehensive approach to reviewing what the
agency calls “chemicals of concern” through the
use of “chemical action plans”32 as part of a
Chemical Safety and Sustainability Program.
The action plans are a centerpiece of the agency’s
stated objective of shifting away from its reliance
on voluntary data programs toward what it calls
an “action-oriented approach” to obtaining and
reviewing chemical data.32
“Chemicals of concern” are divided into seven
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categories. These include chemicals that have a
high production volume; pose a potential risk to
children’s development; appear in biomonitoring, or measurements of chemical concentrations in blood, urine, serum, amniotic fluid,
breast milk, or other sources of human biosamples; or are what is called “PBT”—meaning that
they are persistent or long-lasting, are bioaccumulative (become concentrated within the
bodies of humans or animals), and are toxic. A
review of one of these chemicals may lead to a
number of possible regulatory outcomes: restricting or banning its use, requiring a label
on it, demanding additional testing, or no further action, should the review process remove
any possible concerns.33 Through this effort, the
agency is actively seeking to use its authority to
regulate existing chemicals under section 6 of
the Toxic Substances Control Act—an authority it
has not asserted since the asbestos ruling.
The EPA faces strong resistance to these efforts
from the American Chemistry Council, the
chemical industry’s trade association, which
has questioned the agency’s prioritization of
chemicals of concern as overly subjective.34 At
the same time, the agency is facing expanding
demands to integrate new tools and technologies
into its chemicals program in order to increase
the efficiency of its review process.
For example, the EPA’s latest program,
Advancing the Next Generation of Risk Assessment—a collaboration with the National Institute of Environmental Health Sciences, the National Toxicology Program, the Centers for
Disease Control and Prevention, the Agency
for Toxic Substances and Disease Registry, the
National Human Genome Research Institute,
and California’s Environmental Protection
Agency—is intended to develop cheaper, faster
tests or screens that use advances in molecular
biology to identify high- and low-hazard chemicals.35 We consider such collaborations promising efforts to integrate exciting new technologies—such as high throughput screens, or rapid
tests that identify gene or protein expression or
other biological activity of a compound, and
computational toxicology, or the use of modeling to predict toxic effects—into chemical hazard
assessments. Like many of the voluntary programs developed by the EPA during the past
three decades, including the High Production
Volume Challenge Program,2 these new programs and technologies add tools to the agency’s
arsenal for chemicals management.
The American Chemistry Council supports the
development and use of rapid screening approaches for prioritizing chemicals for additional testing and identifying those compounds
that need no further testing. However, the indus902
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The EPA could ask
individual scholars
and professional
societies to conduct
reviews of chemicals
of concern.
try has no incentive for supporting the use of
these new methods to rapidly and cheaply identify priority chemicals for market restriction.36
Determining how information from these new
tests and screens will be used to restrict and
regulate chemicals, therefore, will probably involve a contentious debate among the regulated
industries, regulators, and the public-interest
community.
What these technological and testing innovations cannot solve, therefore, is the persistent
problem the agency has in exercising its authority to restrict chemicals that present important
risks to health. This is the central limitation on
the EPA’s power to protect the public, as demonstrated in the asbestos case.
The chemical action plans aim to exercise both
arms of the agency’s authority under the Toxic
Substances Control Act: to collect and review
data, and to regulate chemicals that pose serious
hazards. However, the action plans risk falling
into the same trap of a lengthy, contentious review process that the agency has experienced
with other substances, including formaldehyde
and dioxin as well as asbestos. The cycle of seemingly endless analysis followed by a failure to
regulate is due more to the political and economic stakes of the outcome than to any problem
with the agency’s science. For this reason, the
solution will not come from new technologies or
new tests alone. The EPA also needs independent
analysis and review of data that can help mitigate
scientific debate.
One possible way to address the agency’s persistent difficulty in rapidly reviewing and regulating chemicals of concern is to develop collaborative partnerships among the EPA and
academic institutions and professional societies.
In a recent open letter to Science, representatives
of eight major scientific organizations offered
their support to the EPA and the Food and Drug
Administration by volunteering to serve on scientific panels, review specific chemicals, and de-
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To be able to restrict
the use of chemicals
that present a threat
to human health, the
EPA needs support
beyond Washington.
policy making. Researchers at the University of
California, San Francisco, are working with scientists and health practitioners to develop a critical review methodology for use in environmental
health research that could serve as a model.39
This type of support would require no change
to the Toxic Substances Control Act. Moreover,
the production of such reviews could give the
EPA more time and resources to devote to managing risks of chemicals of concern through rule
making and protecting the public’s health.
Conclusion
velop new testing guidelines.37
An example of an ongoing research collaboration between academic laboratories and the
federal government, including the Food and
Drug Administration and the National Institute
of Environmental Health Sciences, involves a
series of studies on bisphenol A, a high-production-volume chemical that has gained a great
deal of attention recently. Through this collaboration, regulatory science—the tools and study
designs used by the agencies—is being updated
and integrated with cutting-edge tools and scientific knowledge developed in academic laboratories around the country.38
To build on and further institutionalize this
academic enthusiasm for working directly with
government agencies, the EPA could ask individual scholars and professional societies to conduct reviews of chemicals of concern. Guided
by evidence-based criteria, transparency, and
strict policies to prevent conflict of interest,
these reviews would apply the expertise of the
academic community to improving chemicals
The authors thank James Aidala, Charles
M. Auer, J. Clarence Davies, Charles L.
Elkins, Mark Greenwood, and Steve
Jellinek for participating in the Chemical
There is a broad consensus today that the Toxic
Substances Control Act needs to be revised to
take advantage of twenty-first-century scientific
knowledge and technological capabilities. We
know far more now about the health risks of
environmental exposures to industrial chemicals than we did thirty-five years ago, when
the act became law. But while stakeholders
debate statutory reform and lawmakers wait
for a window of opportunity to introduce legislation, the EPA needs to continue to build partnerships with other agencies and with groups
outside the federal government to increase the
speed with which it can review high-priority
chemicals.
For the agency to be able to restrict the use
of chemicals that present a threat to human
health, it needs support beyond Washington.
The wider academic community can help by
generating rigorous, transparent, and independent reviews of chemical risks. What’s more,
strengthening the EPA’s existing programs
will be useful in any transition that may come
with reforms of the Toxic Substances Control
Act. ▪
Heritage Foundation’s Oral History
Project of the Toxic Substances Control
Act. This article reflects the individual
views of its authors, not those of the
Johnson Family Foundation or the
Chemical Heritage Foundation.
NOTES
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ABOUT THE AUTHORS: SARAH A. VOGEL
Sarah A. Vogel is a
program officer at
the Johnson Family
Foundation.
In this issue, Sarah Vogel and Jody
Roberts examine whether the Toxic
Substances Control Act, which has
regulated industrial chemicals
since it became law in 1976,
protects the public’s health from
chronic disease risks. They
conclude that the law has fallen
well short of its original intent.
This paper is the first time they
have collaborated, although they
were colleagues for many years,
and their research areas overlap. A
year ago Roberts started an oral
history project on lessons arising
from the toxic substances law, and
he has interviewed many
Environmental Protection Agency
(EPA) administrators and chemical
Health Perspect. 2010;118(6):
A326–7.
&
JODY A. ROBERTS
policy officials. Vogel has been
researching a book on the history
of chemical policy in the United
States.
According to Vogel, conducting
research for the paper allowed her
and Roberts to analyze historical
data on chemicals policy. “We
believe this history is critical,” she
says, “if we are to understand the
problems accurately” and create a
“robust system” to handle the
challenges ahead.
The most surprising result of
their research was understanding
far more fully the “profound lack
of congressional oversight and
public attention to chemical policy
in the perceived failure” of the
Toxic Substances Control Act.
Vogel is a program officer for the
Johnson Family Foundation, which
provides national grants for
environmental health, sexuality,
education, and local development
issues. She has published several
papers on chemicals, plastics, and
public safety. She has a doctorate
in sociomedical sciences from
Columbia University’s Mailman
School of Public Health and
Medicine, a master of public health
degree from Yale University, and a
master of environmental
management degree from Yale’s
School of Forestry and
Environmental Studies.
Jody A. Roberts is
the associate
director of the
Center for
Contemporary
History and Policy
at the Chemical
Heritage
Foundation.
Roberts is the associate director
of the Center for Contemporary
History and Policy at the Chemical
Heritage Foundation. His work
explores molecular sciences and
public policy. He has a master’s
degree in science and technology
studies and a doctorate in
technology studies from Virginia
Tech.
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