A Note on the Toxic Substances Control Act (TSCA)

Since 1976 industrial chemicals typically enter commerce via the legal
authority of the Toxic Substance Control Acts (TSCA) Premanufacture Notification
(PMN) provisions (older substances were grandfathered into commerce). Once
products are in commerce if the EPA, another public health agency, or independent
scientists discover that some substance causes adverse human health effects, it would
typically be addressed by provisions under TSCA or other environmental health laws
such as the Clean Air Act, Safe Drinking Water Act, or the Occupational Safety and
Health Act, to name a few. Common to these laws is that in large measure the
appropriate health agency is authorized to act to protect the public once the product is
shown to be a human health hazard and pose risks or actually cause harm to the
public; that is, after a product is shown likely to cause adverse health effects.

Some history is as follows. In the decade of the 1970s as Congress became
concerned about potentially toxic substances entering the environment, it passed a
variety of laws to try to control chemical risks in the environment through various
mediathe air, rivers, drinking water, consumer products, and the workplace, inter
alia. Some of the legislation was based on nuisance law from torts.
1
Nuisances
include smoke, dust, unpleasant odors, excessive light, loud noises, along with
repeated and annoying phone calls, all of which could interfere with the use or
enjoyment of land. Nuisance law is a postmarket, post-harm law in that a person
whose enjoyment of his land was interfered with (and harmed in this sense) could
bring a legal action for compensation or in less common circumstances for an
injunction against the activity. Thus, with some guidance from older nuisance laws
media-based environmental health laws became postmarket, post-harm enforcement
laws, with some minor qualifications.
However there remained a gap: none of this legislation addressed chemicals
as such, independent of the media in which they appeared. Trying to control toxic
substances media by media was inefficient and duplicative. Consequently, Congress
developed a law that addressed the problem of potentially toxic chemicals more
generally--the Toxic Substances Control Act (TSCA). This established a substantive
blueprint to guide the entry of the vast majority of new humanly created chemicals
(eighty to ninety percent) into commerce. After products have entered commerce,
TSCA and other postmarket laws establish both procedural and substantives to guide
agencies in identifying and reducing risks from the products. These authorize an
agency to conduct appropriate fact-finding to identify risks that exist or harms that
have occurred from environmental or workplace exposures (e.g., a scientific task).
They then empower the agency to issue a rule through a specified procedure to
reduce or eliminate the risks or harms to bring exposures to the substance into
compliance with the law (a combined legal and scientific task).
According to the Council on Environmental Quality (CEQ), which played an
influential role in spurring and supporting the legislation, two goals of TSCA were a)
to avoid repairing damage after it has been done; [and b) not allowing] the general
population to be used as a laboratory for discovering adverse health effects.
2
In
effect the CEQ rejected both the tort system and existing postmarket laws to control

1
William H. Rogers, Environmental Law, 2d Ed., (St. Paul., Minn.: West Publishing Co., 1994),
pp.
2
U.S. Council on Environmental Quality, Toxic Substances, Washington, D.C., 1971, p. 21
(emphasis added).
exposures to toxicants, endorsing instead some kind of licensing mechanism of the
kind that exists for prescription drugs and pesticides.
3
Congress failed to follow the
CEQs recommendations.
One gesture in TSCA toward trying to detect the toxicity of chemicals before
public exposures result led to a pre-market premanufacture notification provision
for each new chemical. Companies seeking to manufacture new chemicals or use
existing chemicals for substantial new purposes must notify the EPA by submitting a
Premanufacture Notification (PMN) to the EPA before they may manufacture the
product. The PMN must include all available data on chemical identity, production
volume, by-products, use, environmental release, disposal practices, and human
exposures.
4
If a company has conducted any toxicity tests, it must submit them, but
if it has not, there is nothing to submit. The EPA must take what it is given.
5

Unfortunately and quite importantly, the law requires no routine toxicity or
health effects data before a product is proposed for manufacture and
commercialization, unless it is likely to pose unreasonable risks to public health or
the environment. Of course, a company is not likely to have data on unreasonable
risks unless it has conducted appropriate tests. Legislators and others perhaps hoped
at the time that companies would do more toxicity testing and report their results in
order to protect the public.
6
This voluntary option has not been taken and in fact
many companies ceased testing their creations at all. Some closed their toxicology
departments.
7
Quite significantly, TSCA explicitly forbids promulgation of blanket
testing requirements for all new chemicals.
8

If the EPA can discern from the minimal information in a PMN that a
substance proposed for manufacturing poses an unreasonable risk (mainly from the
structure of the chemical suggesting adverse biological activity and perhaps
analogues to known toxicants), by issuing a test rule it may order the company to
conduct toxicity tests of the product.
9
If the company challenges it and EPAs
determination is well supported, it is required to file an injunction in the U.S.
District Court, a quite burdensome and time-consuming process.
10
As of September
30, 2005, EPA reported it had taken 3,899 regulatory or voluntary actions to gather
data or restrict use of roughly 10% of all PMNs. Most of these were based on
consent orders with a few based on a rule-making.
11
Other data suggest much lower
numbers, at least for required testing.
12

However, issuing a rule is not a burden that is easily carried: it is a
burdensome task that requires substantial time and effort along with finding or
developing data that the substance poses unreasonable toxic risks. Moreover, the

3
Applegate, Synthesizing TSCA and REACH, p. 107.
4
EPAs New Chemicals Program Under TSCA: The Basics, located at
http://www.chemalliance.org/topics/?subsec=27&id=689
5
John S. Applegate, Synthesizing TSCA and REACH: Practical Principles for Chemical
Regulation Reform, Ecology Law Quarterly 35 (2009): pp.721-768, at pp. 735.
6
Linda-Jo Schierow, The Toxic Substances Control Act (TSCA): Implementation and New
Challenges, Congressional Research Service, Report # 7-5700 (July 28, 2009), p. 2, 4,
7
Myron Melman and David A. Eastmond.
8
Linda-Jo Schierow, The Toxic Substances Control Act (TSCA): Implementation and New
Challenges, Congressional Research Service, Report # 7-5700 (July 28, 2009), p. 4.
9
Schierow, pp. 2-3.
10
U.S. Environmental Protection Agency, Appendix: The Toxic Substances Control Act: History
and Implementation, p. 111, located at www.epa.gov/oppt/ newchems/pubs/chem-
pmn/appendix.pdf (accessed 4/22/10).
11
Schierow, p. 9.
12
Joseph H. Guth, Richard A. Denison, Jenifer Sass, Require Comprehensive Safety Data for All
chemicals, New Solutions, Vol. 17(3) 233-258, 2007
agency is understaffed and underfunded, exacerbating the problem. As John
Applegate has argued, in order to require the testing of a substance the EPA must
demonstrate that the chemical may present an unreasonable risk, and thus needs
additional information to make a decision about regulation, [but this] creates a
regulatory Catch-22: EPA must have chemical information in order to prove that it
needs it, but it needs the information because it does not have it.
13
Lynn Goldman,
former Administrator of Pesticides and Toxic substances, concurs: [I]ts almost as if
we have to, first prove that chemicals are risky before we can have the testing
done to show whether or not the chemicals are risky.
14

Under other postmarket laws, none of which have a PMN provision, only
after a substance has been identified as toxic (under some laws) or a suspected
toxicant (under others) may the respective public health agency take some
appropriate action to reduce risks or prevent harm. The Occupational Safety and
Health Act, the Safe Drinking Water Act, the Clean Water Act and the Clean Air Act,
inter alia, are all reactive laws in this sense. The public is protected by a public
health agency taking a post-harm or post-risk action after data reveals that
citizens are likely put at risk (or harmed) and relevant provisions of the applicable
law have been violated.
15
If these laws are inadequate to the task, the EPA has the
authority to reduce risks under TSCA.
16


Because TSCA and other postmarket laws typically permit substances to
remain in commerce until the appropriate public health agency makes a scientific and
legal case for reducing risks, the public remains exposed to toxicants for a substantial
period of time. The Toxic Substances Control Act, section 6 provides one legal
mechanism that aims at reducing unreasonable risks from substances already in
commerce. However, because of high evidentiary hurdles and a quite adverse court
decision, this has nearly paralyzed the EPA in regulating toxic substances under
section 6.
17
There likely will be no future enforcement actions under this section. For
example, the agency after a decade of work and a 45,000 page record tried to ban
virtually all uses of asbestos, but was prevented from doing so by a cramped

13
Applegate, at 738.
14
Schierow, p. 12.
15
For instance, for toxic exposures in the workplace the Occupational Safety and Health Act
requires that the Occupational Safety and Health Administration (OSHA) must set a workplace
health standard that most adequately assures, to the extent feasible, that no employee will
suffer material impairment of health or functional capacity even though the employee has regular
exposure to the substance for his working lifetime (forty-five years). (OSHA Act, section 655(b)(5)
(1970)) If the EPA under the Clean Air Act finds that the public is exposed to a hazardous
substance such as a carcinogen, taking into account sensitive subpopulations such as the elderly,
children and those with pre-existing diseases, it is authorized to address it. This can only occur
after the carcinogen has been identified and put on a list for EPA action. The EPA is not required
to identify carcinogens emitted into the air before they may be emitted. The EPA must then set
standards that will achieve this goalthe most exposed person must have no greater than a one in
a million risk of contracting cancer from the exposure. If technology controls can reduce exposures
to such substances sufficient to protect the public, the EPA is done. However, if technology-based
controls are inadequate, the agency must set residual risk standards that protect public health with
an ample margin of safety.
16
Schierow, p. ___
17
Linda-Jo Schierow, The Toxic Substances Control Act (TSCA): Implementation and New
Challenges, Congressional Research Service, Report # 7-5700 (July 28, 2009), p. 17, located at
www.crs.gov (citing Robert B. Haemer, Reform of the Toxic Substances Control Act: Achieving
balance in the regulation of toxic substances, Environmental Lawyer, v. 6, n. 99 (1999), pp. 118-
119).
interpretation of the law and a decision from Fifth Circuit Court of Appeals.
18
Other
agencies, e.g., OSHA, the Consumer Product Safety Commission, and other
subsections of the EPA, working under within their jurisdictions face somewhat
similar postmarket enforcement difficulties, but they are not as onerous as those
under TSCA section 6. Nonetheless agencies can be quite slow to identify toxic risks
and act to reduce them
One indication of how slowly agencies protect the public under postmarket
laws is the length of time it took for environmental health agencies to act on known
carcinogens when the scientific data was available (the Office of Technology
Assessment study noted earlier
19
). Another is how long it takes for the EPA under its
Integrated Risk Information System (IRIS) to evaluate information on health effects
that may result from exposure to environmental contaminants for protecting the
publics health.
20
The EPA has worked more than twenty years on trichloroethylene
(a known human carcinogen, cause of Parkinsons disease, cause of birth defects, and
common contaminant in drinking water [not completed]), more than 25 years on
dioxin (known human carcinogen and contaminant in food and from many other
sources [partially finished]), thirteen years on perchlorate (a common contaminant in
water and known to retard neurological development in developing children [not
completed]), eleven on formaldehyde (a known human carcinogen and leukemogen
and common in many household products [not finished]), and nine for naphthalene
(resulting in military exposures) before work was suspended on it.
21

Once exposures to substances have been found sufficiently toxic to violate
the law, postmarket laws frustrate and delay comparatively quick administrative
actions to remove substances and prevent further violations that cause harm to others.
First, an agency must discover whether or not exposure to a product poses risks or
causes harm in violation of the pertinent law. Thus, agencies typically carry out
typical steps of risk assessment: they determine whether the substance is a hazard,
what exposures exist, and whether, given those exposures, there are risks to the
public that exceed substantive legal standards. Recall that OSHA must find that a
working lifetime exposure to a product will result in material impairment of
employees health or functional capacity. Under the Clean Air Act the EPA must find
that exposures to hazardous substances do not protect the publics health with an
ample margin of safety, taking into account sensitive subpopulations.


18
Ibid., pp. 17-18.
19

20
U.S. Environmental Protection Agency, Integrated Risk Information System (IRIS), located at
http://www.epa.gov/IRIS/
21
General Accounting Office, Chemical Assessments: Low Productivity and New Interagency
Review Process Limit the Usefulness and Credibility of EPAs Integrated Risk Information System,
Report number GAO-08044 (2008).