Environmerttal Protection
       Toxic Substances
EPA   Chemicals
       and the
       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.

and the
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
  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
  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
  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-

 • 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-

 • 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

 •  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
  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-

•  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-
   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°

• Its symptoms do not show for  many years after ex-

• Some chemicals cause cancer in laboratory animals.

• With one or two exceptions, every chemical that
causes cancer in  humans also causes it in laboratory

  Other things about cancer are still the subject of  ex-
periment and investigation. For example:

• whether any given benign tumor will  transform into

• 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
   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

   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
   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-

 •  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

 •  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;

  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.
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