Environmerttal Protection
Agency
UKA MU/e
Toxic Substances
EPA Chemicals
and the
Regulatory
Facts of Life
-------
EPA is charged by Congress to protect the Nation's land/ ail
and water systems. Under a mandate of national en-
vironmental laws focussed on air and water quality, solid
waste management and the control of toxic substances,
pesticides, noise and radiation, the Agency strives to for-
mulate and implement actions which lead to a compatible
balance between human activities and the ability of natural
systems to support and nurture life.
-------
Chemicals
and the
Regulatory
Facts of Life
Remarks by
The Honorable Steven D. Jellinek
Assistant Administrator for Toxic Substances
The United States Environmental Protection Agency
Prepared for Delivery Before the
Monsanto Corporate Environmental
Control Workshop
St. Louis, Missouri
Wednesday, May 24, 1978
-------
The ti'Ie I've chosen for my remarks this es'ening is
"Chemicals and the regulatory facts of life." If I
accomplish nothing else, I hope to leave you with a
better appreciation of the challenges posed by chemical
regulation and with the certain knowledge that EPA is
moving vigorously ahead to meet those challenges.
The Toxic Substances Control Act of 1976—or
TSCA, as it is known—gives EPA a mandate to protect
public health and the environment from the unreason-
able risks of chemical substances.
TSCA, of course, is not the first Federal law to ad-
dress the serious health and environmental problems
associated with toxic chemicals in our society. Fourteen
other major Federal laws also have such provisions; six
of these are administered by EPA—the remainder by
the Food and Drug Administration, the Occupational
Safety and Health Administration, the Consumer Prod-
uct Safety Commission, and the Department of
Transportation.
With all of these other laws, you might ask, doesn't
TSCA seem a bit redundant?
Much of the 5-year debate in Congress that preceded
TSCA's final enactment in October 1976 focused on
various aspects of that very question. In the end, Con-
gress and the President concluded—with the support of
an extraordinarily broad-based coalition of industry,
labor, environmental, consumer, and other groups—
that enactment of TSCA was necessary to fill a number
of significant gaps that exist in the other Federal toxics-
related laws.
One of the major concepts—and one of the major
distinctions—underlying TSCA is that the public in-
terest requires EPA to have the capacity to act before
harmful substances threaten human health or the en-
vironment. The other laws, Congress found, largely
enable the government to take action only after wide-
spread exposure and possibly serious harm has
occurred.
And this gets to the very heart of TSCA's purpose—
and distinctiveness—as perhaps our most far-reaching
public-health law yet.
TSCA provides EPA with comprehensive and flexible
authority to gather certain kinds of basic information
on chemicals, to identify harmful substances, and to
control those toxic chemicals whose risks of injury to
public health and the environment outweigh their bene-
fits to society and the economy. The reach of the law is
extremely broad. It encompasses the estimated 70,000
chemical substances manufactured for commercial pur-
poses and several million research and development
chemicals.
It makes the entire chemical industry subject to com-
prehensive Federal regulation for the first time. EPA's
authority under TSCA is extended into virtually every
facet of industry—product development, testing, manu-
facturing, processing, distribution, use, and disposal.
And because the Act treats importers of chemical sub-
stances as if they were domestic manufacturers, it also
-------
expands EPA's responsibilities into certain aspects of
the multibillion-dollar international chemical trade.
Most of TSCA's authorities, however, are discre-
tionary—that means Congress has given EPA the
necessary flexibility to apply a variety of non-regulatory
and regulatory options in controlling the problems
posed by toxic-chemical hazards in our society.
Our actions can range from jawboning to non-
mandatory guidelines, limited regulation of handling,
use, and labeling, or outright bans on manufacturing
and processing.
With all of TSCA's flexibility and discretion, given
limited resources, and in light of the enormous number
of potential targets for attention, EPA's efforts to
implement this law must be well-focused and deliberate.
In this regard, EPA has already set a number of
policy and program priorities:
From the standpoint of policy:
• We will give highest priority to substances that pose
the greatest risk as a function of both toxicity and ex-
posure.
• Chemical substances that may produce chronic and
irreversible health effects such as cancer, birth defects,
and gene mutations will take higher priority than those
that produce acute effects such as eye and skin irrita-
tions.
• Substances that are widely dispersed in the environ-
ment and that may significantly disrupt ecosystems will
take a higher priority than those that threaten individ-
ual species other than man.
Programmatically, in our initial efforts under TSCA:
« We will give highest priority to testing and
information-gathering and to establishing the pre-
manufacture notification program. This will help to
build a firm basis for fulfilling TSCA's preventive
health promise and for controlling potentially hazard-
ous substances about which we currently know little or
nothing.
• At the same time, we will focus a significant propor-
tion of our resources on assessing the risks of known
high-toxicity, high-exposure substances and on taking
early regulatory action where those risks outweigh the
chemicals' benefits.
• We will use actions under TSCA to promote effective
control of toxic substances under other laws.
I believe that these are sound priorities. They
represent a responsible approach to the mammoth
task we face in carrying out Congress's intent.
Yet I am also aware of—and quite concerned
about—an attitude of some within the chemical in-
dustry these days: that government is on some kind
-------
of a chemical "witch hunt"—that we viesv all chemiea
as inherently "bad" until proven "good," and that we
make our regulatory decisions largely on the basis of
fear, emotion, and hidden bias against chemicals.
Those who embrace this point of view often portray
government regulators as naive, unscientific types who
casually arrive at regulatory decisions using a dart
board that's one big bull's eye and labeled "industry."
Although I'm sure that this kind of paranoia about
EPA is not widely shared by representatives of industr;
it is indicative of much of the current national concern
about over-regulation. In my experience, over-
regulation simply is not one of the regulatory facts of
life.
On the contrary, the regulatory facts of life tend to
temper the process of administering TSCA. They make
it very unlikely that EPA would be able to foist sloppy
or poorly developed decisions on an unsuspecting in-
dustry. Let me give you a few examples:
First, under the law EPA is bound to implement
TSCA in a "reasonable and prudent manner," and we
must "consider the environmental, economic, and socio
impact of any action" we take under the Act.
Second, the law provides ample opportunity for
public and judicial review of EPA actions or non-
actions, including the following:
• TSCA and the Administrative Procedures Act require
that all rules under TSCA be subject at least to com-
ments from the public in writing, and in many cases
public hearings are required that may involve cross-
examination.
• Further, all actions under TSCA are subject to
judicial review. Actions to remove imminent hazards
can only be taken through U.S. District Courts. And
EPA is subject to lawsuit on each and every regulation
it promulgates under TSCA.
• Also, citizens may bring actions to compel EPA to
perform non-discretionary duties under TSCA, and to
compel violators to comply with TSCA if EPA does not
do so.
• And finally, citizens may petition EPA to initiate
rulemaking proceedings; if EPA does not do so, they
may go to court to try and force EPA to do so.
Third, in order to minimize the chance that we will
be sued—and to maximize the chance that we will win
if we are sued—EPA has to do its homework. We must
be well-prepared. Our decisions have to be documented
and defensible. For example, the regulations for the
chemical inventory reporting took literally thousands of
hours to develop. And we estimate that it will take a
-------
similar investment in resources to complete the
regulatory process on any given chemical in a way that
is scientifically respectable and legally sufficient.
Fourth, beyond the requirements of the Administra-
tive Procedures Act, EPA is committed to involving the
public—including the chemical industry and other in-
terested groups—in our decision-making process. The
inventory regulations are again instructive. EPA held
eighteen public meetings on them between December
1976 and October 1977. On these occasions representa-
tives of industry, labor, environment and other groups
met with EPA staff to work out differences on how the
inventory procedures should be carried out. All parties
agreed that the regulations were improved by that pro-
cess.
Fifth, at each step of the way toward a regulation
EPA's decision makers are subject to careful scrutiny
by interested parties inside government as well as by our
outside constituencies. EPA's own internal decision and
rulemaking procedures require extensive coordination
with other offices. Our colleagues in the Council of
Economic Advisors, the Council on Wage and Price
Stability, and the Department of Commerce keep close
tabs on our activities. The Office of Management and
Budget takes a special interest in our resource re-
quirements and monitors the record-keeping and report-
ing we may require of industry. And five separate Con-
gressional Committees exercise the Constitutional pre-
rogatives of guidance, oversight, and appropriations.
Sixth, the system subjects EPA to a number of other
constraints that 1 doubt are shared by our counterparts
in industry. Our staffing levels—though growing—are
limited by the need to keep overall Federal employment
down. We now have about 150 people on board and
hope to add 200 more to the TSCA-related staff of the
Office of Toxic Substances by the end of next year.
Once we've been authorized to hire a person, it takes
an average of 6-9 months to fill the vacancy on our
staff—from the time the position becomes available to
the time the person actually reports for duty. That kind
of delay is formidable when you consider the fact that
we are competing in the open job market for highly
sought-after scientific talent.
The seventh regulatory fact of life concerns the need
to make decisions in the face of uncertainty. I briefly
mentioned earlier the many unknowns we must deal
with every day. Let me elaborate. We don't even know
yet how many chemical substances are in commerce.
For most substances we know little if anything about
how they are used, what health or environmental effects
they may cause, who gets exposed to them and how,
and what is the result of such exposure. Although we
will use TSCA's powerful testing and information tools
to narrow the gaps in our knowledge, we will never be
able to answer every question to everyone's satisfaction.
-------
In order to fulfill our public trust we must often act c
the basis of partial or incomplete evidence.
The regulation of carcinogens provides a perfect ca<
in point. Some things are certain about cancer:
• It is the second leading cause of death in the U.S. t°
day.
• Its symptoms do not show for many years after ex-
posure.
• Some chemicals cause cancer in laboratory animals.
• With one or two exceptions, every chemical that
causes cancer in humans also causes it in laboratory
animals.
Other things about cancer are still the subject of ex-
periment and investigation. For example:
• whether any given benign tumor will transform into
malignancy;
• whether there is a threshold below which exposure t<
a chemical does not cause cancer;
• whether every chemical that causes cancer in animals
also causes it in man.
Science cannot prove beyond doubt the connection
between cancer in humans and cancer in the animals
used in toxicological studies. Yet we are responsible fo
protecting the public from exposure to carcinogens. W
can't wait for proof-positive in the form of dead
bodies.
Instead, we must assume—in the public interest—thg
a benign tumor may be the precursor of a malignant
tumor, that any exposure to a carcinogen may pose
some risk, and that a chemical shown to be carcino-
genic in animals is potentially carcinogenic in humans.
Risk, of course, is only one side of the equation.
TSCA explicitly requires us to take the benefits of a
chemical substance into account. We can only act
against a chemical if we can demonstrate that it poses
an unreasonable risk—that is, if the risks to health or
the environment outweigh the social and economic
benefits of the chemical.
Implicit to this balancing of risks against benefits is
the need for us to concentrate on real-life problems-
problems whose actual or potential magnitude present
the greatest possible opportunities for assessing risks in
relation to benefits.
There's one final regulatory fact of life under TSCA
that I want to mention this evening. From industry's
point of view, it's probably the most important one of
all.
-------
Although EPA is responsible for carrying out this
law, the industries affected by TSCA must shoulder a
tremendous share of the burden for making sure that
the law works, and that it works well.
1 am not talking about the need to enlist industry in
the ranks of those who support the underlying prin-
ciples upon which TSCA is founded—namely, that the
Nation has a right to be protected against unreasonable
chemical risks. Most responsible members of industry
are already in those ranks, and have been for some
time.
Instead, I am talking about some specific forms of
cooperation under TSCA that are very much in in-
dustry's self-interest. Let me give you a few frank ex-
amples:
• First, in submitting chemical data to EPA under
TSCA, industry must avoid frivolous claims of con-
fidentiality. We are aware of industry's concerns about
confidentiality, and have developed procedures for
handling confidential industry data that we believe are
second to none, in government or in industry. But in
order to work properly, our data security system must
not become overburdened with "confidential" informa-
tion that really isn't confidential at all. Already there
have been a few isolated cases where companies have
submitted data under TSCA as confidential when we
know the same information has been given non-
confidentially to other agencies. We consider this to be
an abuse of the protection TSCA provides against
unauthorized disclosure of confidential business infor-
mation, and we are not going to tolerate it. A manu-
facturer making obviously frivolous claims of confiden-
tiality will in the eyes of the Agency cast doubts about
the veracity of future claims. Such a practice on a
broad scale will force the Agency to tighten its policy as
to the circumstances under which claims will be
honored.
• Second, industry must make every effort to comply
rationally with TSCA's key pre-manufacture notifica-
tion and review provisions under section 5. Industry
should view our recommended guidelines for testing and
other kinds of data as minimum requirements, and
should exercise its best scientific judgment in assessing
the risks of new substances and uses. We view these
data as essential to performing our required review of
new chemicals and significant new uses of existing
chemicals. Where a scientifically responsible decision
would be to perform additional tests, we expect in-
dustry to do so rather than wait for EPA to intervene.
Further, industry should only submit notices for
chemicals that it actually intends, in good faith, to in-
troduce into commerce. Otherwise, a central element in
TSCA's preventive approach will become paralyzed
with unnecessary work—and if this happens, I assure
-------
you that EPA will seek stronger pre-manufacuiring
review authority to remedy the situation.
• Third, companies that have not yet done so must
establish logical internal procedures for deciding wha
kinds of information need to be reported to EPA un
TSCA's section 8(e) authority to require notices of
substantial risk. Non-compliance with this provision
the Act, or malicious compliance—that is, submitting
notices of non-substantial or obscure risk—will discn
industry and force EPA to take strong enforcement
measures that industry would not favor. Moreover, ii
dustry should not stop ongoing or planned testing sir
ply in order (o avoid the requirements of section 8(e)
• Fourth, industry must insure that data it submits tc
EPA under TSCA meet the high standards for good
laboratory practices. Our recommended standards un
section 4 of TSCA should, if followed, go far toward
avoiding the kinds of outrageous and fraudulent prac
tices that have been the focus of recent national alien
tion. And again, we will forced to take tough remedi;
action if failure to voluntarily adopt such practices
compromises our ability to fulfill TSCA's national m;
date.
My purpose in laying out this final regulatory fact <
life is to encourage industry to protect its own prerog,
lives under the present version of TSCA. The Dexibili
and discretion that TSCA provides apply to industry ;
well as to EPA, and must be exercised with equal
restraint, reason, and common sense.
Knowing more now than you might have before ab(
some of the regulatory facts of life under TSCA, it
should be clear to you that many of the toughest deci
sions under this law are yet to be made. The course th
we take in the coming months and years largely depen
on how wisely we chart our way through these early
days. As each day passes, our knowledge about toxic
substances seems to grow exponentially. Yet we remaii
humbly aware, as Walter Lippmann once wrote, that
"the distance between what we know and what we net
to know appears to be greater than ever."
Closing that gap in an area that bears singnificantly
on the Nation's future health and environmental quali
is what TSCA is all about.
I reflect the hope of many at EPA and in this Ad-
ministration that, with the continued advice, support,
and cooperation of industry, history will prove TSCA
to have been a good idea, well executed. D
-------
If you have suggestions,
questions, or requests
for further information,
they may be directed
to your nearest
EPA Regional
public information office.
EPA Region 1
JFK Federal Bldg.
Boston MA 02203
Connecticut, Maine, Massachusetts.
New Hampshire, Rhode Island,
Vermont
617-223 7210
EPA Region 2
26 Federal Plaza
New York NY 10007
New Jersey, New York. Puerto
Rico. Virgin Islands
212-2642525
EPA Region 3
6th and Walnut Streets
Philadelphia PA 19106
Delaware, Maryland, Pennsylvania,
Virginia, West Virginia, District of
Columbia
215-597 9814
EPA Region 4
245 Courtland Street NE
Atlanta GA 30308
Alabama, Georgia. Florida,
Mississippi. North Carolina. South
Carolina, Tennessee, Kentucky
404-881 4727
EPA' Region 5
230 S. Dearborn
Chicago IL 60604
Illinois, Indiana, Ohio, Michigan,
Wisconsin, Minnesota
312353-2000
EPA Region 6
1201 Elm Street
Dallas TX 75270
Arkansas, Louisiana, Oklahoma,
Texas, New Mexico
214-767-2600
EPA Ragion 7
1736 Baltimore Avenue
Kansas City MO 64108
Iowa, Kansas, Missouri, Nebraska
816-374-5493
EPA Region 8
1860 Lincoln Street
Denver CO 80203
Colorado, Utah. Wyoming, Mon-
tana, North Dakota, South Dakma
303-8373895
EPA Region 9
215 Fremont Street
San Francisco CA 94106
Arizona, California, Nevada, Hawaii,
Guam, American Samoa, Trust Ter-
ritories of the Pacific
415-556-2320
EPA Region 10
1200 Sixth Avenue
Seattle WA 98101
Alaska, Idaho, Oregon, Washington
206-442-1220
------- |