United States
Environmental Protection
Agency
Office of
Public Affairs (A 107}
Washington DC 20460
Volume 10
Number
December 1984
Protecting Public Health
-------
Rush hour commuters at a busy downtown
intersection in Washington, D.C. EPA
assesses and manages environmental risks
to protect all segments of the population.
Protecting Public Health
Why are risk assessment and risk
management so important in
EPA's efforts to guard public
health? What do they mean?
How are they working?
EPA Journal asked such
questions in an interview with
the agency's administrator,
William D. Ruckelshaus, who has
established risk assessment and
risk management as basic tools
at EPA. The interview is featured
in this issue of the magazine.
The Journal then asked three
top agency officials to explain
various aspects of risk
assessment and risk
management. Bernard Goldstein,
Assistant Administrator for
Research and Development,
reports on developments that
will be strengthening the practice
of assessing risks to health. John
Moore, Assistant Administrator
for Pesticides and Toxic
Substances, explains the nuts
and bolts of some risk
management decisions.
Josephine S. Cooper, Assistant
Administrator for External
Affairs, describes the challenge
of communicating risk to the
public. Strategies to unify EPA's
approach in using risk
assessment and risk
management are spelled out in
an article by Bob Burke, who is
on the staff of the agency's
Office of Public Affairs.
Judith E. Ayres, administrator
of EPA's Region 9, describes the
use of risk assessment and risk
management in environmental
decision making. Her piece, the
fourth in a series in the Journal
by the agency's regional offices,
views the cleanup effort in
California's Santa Clara Valley,
better known as Silicon Valley.
The pros and cons of using
animal testing to assess
chemical risks to human health
are discussed from two different
viewpoints by Dr. David P. Rail,
Director of the National Institute
of Environmental Health
Sciences and the National
Toxicology Program, and Dr.
George Roush, Jr., Director of
Medicine and Environmental
Health at the Monsanto
Company.
Several articles in this issue
look at other subjects of interest
at EPA: the recently passed
amendments to the Resource
Conservation and Recovery Act
(RCRA); the kind of people who
work at EPA; and the use of
trained dogs to track down
hazardous wastes. A drive by the
3M Company in Minnesota to
stop industrial pollution before it
occurs is described in another
article.
Wrapping up this issue of the
magazine are two regular
features—Update, which sums
up recent developments at EPA,
and Appointments. [ i
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United States
Environmental Protection
Agency
Office of
Public Affairs (A 107)
Washington DC 20460
Volume 10
Number 10
December 1984
X-/EPA JOURNAL
William D. Ruckelshaus, Administrator
Josephine S. Cooper, Assistant Administrator for External Affairs
Jean Statler, Director, Office of Public Affairs
John Heritage, Acting Editor
Susan Tejada, Associate Editor
Jack Lewis, Assistant Editor
EPA is charged by Congress to
protect the nation's land, air, and
water systems Under a mandate of
national environmental laws, the
agency strives to formulate and
implement actions which lead to a
compatible balance between human
activities and the ability of natural
systems to support and nurture life
The EPA Journal is published by
the U S. Environmental Protection
Agency The Administrator of EPA
has determined that the publication
of this periodical is necessary in the
transaction of the public business
required by law of this agency. Use
of funds for printing this periodical
has been approved by the Director
of the Office of Management and
Budget. Views expressed by
authors do not necessarily reflect
EPA policy Contributions and
inquiries should be addressed to the
Editor (A-1071. Waterside Mall. 401
M St., S.W.. Washington, D.C.
20460. No permission necessary to
reproduce contents except
copyrighted photos and other
materials.
£V\
v9
rw
O
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foreign countries is $25.00 a year.
The price of a single copy of the
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The requests should be mailed to:
Superintendent of Documents
GPO, Washington, D.C 20402.
EPA's Strategy
to Reduce Risks 2
An Interview with
William D. Ruckelshaus
Strengthening the
Assessment of Risk •-•
by Bernard D. Goldstein
Making Decisions
About Risk 8
by John Moore
Helping the Public
Weigh Health Threats 10
by Josephine S. Cooper
Some ABCs in
Addressing Risk
by Bob Burke
-
Controlling the Dangers
from High-Tech
Pollution
by Judith E. Ayres
Is Animal Testing
Overrated?
Two Views 'IS
Summing Up the
New RCRA Law 20
by Jack Lewis
The People
at EPA 23
by Margherita Pryor
Four-Footed Detectives 25
by Susan Tejada
Making Pollution
Prevention Pay
by Dr. Robert P. Bringer
Update: Recent
Agency Developments
Appointments at EPA :-v
As the EPA Journal went to
press, President Reagan
named Lee M. Thomas as his
choice to succeed William D.
Ruckeishaus as Administrator
of the EPA. Thomas is
currently the agency's
Assistant Administrator for
Solid Waste and Emergency
Response. Ruckelshaus has
announced his resignation to
become effective January 5.
Front cover: Village of Stowe, Vt.
Photo by Michael Philip Manheim,
Folio Inc.
Design Credits: Robert Flanagan;
Ron Farrah.
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EPA's Strategy to Reduce
Risks
An Interview with
William D. Ruckelshaus
EPA Journal discussed with
Administrator William D. Ruckelshaus
the concepts and the issues involved in
risk assessment, risk management, and
risk communication as practiced by the
agency. The interview follows:
Q
In a speech to the National
Academy of Sciences last year, you
established risk assessment and risk
management as guiding principles for
EPA's future. What do these terms mean,
and why are they so important?
A
Let me answer your second.
question first. I think it's important for
the agency to have a consistent
conceptual framework as a basis for
understanding our mission and how
we're going to achieve that mission.
When we first started at EPA in 1970, we
didn't have that conceptual framework.
To a certain extent, we were groping in
the dark. During the decade between the
time I left here and came back, an
awareness developed that the needed
framework might be founded on the
distinction between the assessment of
risk and the management of risk.
As for our definitions of the terms: risk
assessment is simply an effort to
understand what the problem is—what is
the risk that you're attempting to reduce
in order to protect the public health and
environment? Strictly speaking, even the
assessment of risk isn't a purely scientific
exercise. We do have to make some
assumptions—which have a scientific
base, but, nevertheless, are assumptions.
Now, once we've defined the problem,
we can move to the next stage of our
regulatory responsibility: deciding what
to do about the risk. This is the risk
management stage. We try to balance
the risk against other social concerns,
such as the benefits associated with the
use of a particular chemical, and the cost
of reducing its use.
Q
Q
Looking over the past 18 months,
what progress has the agency made in
implementing the concepts of risk
assessment and risk management?
A
We have just proposed guidelines
for assessing risk across all of the
program areas of the agency. They are
primarily for internal guidance, to ensure
consistency across the agency in the way
we assess risk for carcinogens,
mutagens, teratogens, etc.
EPA will be using these proposed
guidelines internally while the public
comment process is going on.
Meanwhile, we are attempting to come
up with a consistent set of guidelines
within the risk management agencies of
government for the assessment of risk, it
could be that through that process we'll
change our mind about exactly how risk
should be assessed. But if we're going to
have any chance of getting a consistent
assessment of risk across all the
risk-management agencies of
government, we've got to start inside
EPA.
Q
Should our environmental statutes
be modified to better reflect the
concepts of risk assessment and risk
management?
'» Congress has given us such a wide
array of assignments that it, like EPA, is
sometimes confused as to exactly what
we're supposed to do and whether or not
we are making progress. The task of
overseeing our administration of the laws
would be much easier if the statutes
themselves explicitly distinguished
between what is primarily a scientific
exercise in assessing risk and the
political—small "p"—political exercise of
deciding what to do about it.
Does EPA intend to propose such
statutes in the next Congress?
f^ The short answer to your question
is yes. So far, however, I have refrained
from recommending such changes
because I've felt the Congress was
unlikely to be receptive. I haven't wanted
to run the risk of discrediting any useful
approach by suggesting it in a highly
politicized climate. The longer answer to
your question, therefore, is that,
assuming the climate is modified, I think
we have a chance of getting a fair
hearing in Congress.
Q
Could you cite a particular instance
in which risk assessment and risk
management have been utilized
particularly well?
r\ Actually, we operate under the
same general formulation in virtually
every decision that we make. In my own
view, the effort that the agency made to
control EDB was a success. The risk
assessment of EDB exposure contains
great scientific uncertainty insofar as the
ability to extrapolate to humans the
information we had on EDB's effects on
animals. Given that uncertainty, we did a
fair job of describing the risk to the
public. Then we managed the phasing
down, and eventually the phasing out, of
EDB, taking into account the cost of
doing it, the pace of doing it, and the
residual health exposure of people, I
think we integrated these things into a
risk management approach that carried
the day in a highly politicized, emotional
atmosphere.
Q
How are you ensuring good science
in risk assessment?
A
In the first place, I think we're very
open about the assumptions we make in
assessing risk. We subject our
methodologies to extensive peer review.
We subject the scientific studies on
EPA JOURNAL
-------
which we base our risk assessment
decisions to peer review. Then the risk
assessment documents are reviewed by
our own Science Advisory Board. So that
we go through a widespread, open, peer
review process before we come to some
judgment about the nature of the
problem. That does more to ensure that
our science is sound than anything else.
It also is important that we manage our
scientific research effort in such a way
that we ask the right questions in
sufficient time so that the
decision making can be based on a solid
scientific foundation.
Administrator Rucke/shaus
Once we agree on the facts, people
may still disagree on how we ought to
assess the risk. As I pointed out earlier,
there are assumptions involved in risk
assessment. I've had scientists sit here in
my office and be poles apart on the risks
associated with a particular substance.
Then it's up to me to make a judgment.
Q
As the facts are being gathered on
the risk assessment side, when does the
policy-maker step in and say, "That's
enough. We have sufficient information
to make a decision"?
Q
A
What about disagreements? What
does EPA do when scientists within the
agency offer conflicting risk assessments
for the same substance?
r\ We have recently established a risk
assessment forum. When there is a lack
of consensus on a chemical's risk, the
forum attempts to find out why.
Differences may be caused, on the one
hand, by scientific uncertainties, or they
may result from different methodologies
being applied to come up with a risk
number. In the latter case, the forum can
help straighten things out by seeing that
common methodologies are utilized.
That's going to vary. Sometimes the
decision is hastened by public pressure
to act on a particular substance.
Sometimes a certain time frame is
mandated by statute. And sometimes the
policy-maker decides that we know
enough, even though a lot more
information would be helpful and make
the policy-maker feel more comfortable.
Getting information can be very
expensive and very, very time
consuming. There is such a thing as
paralysis by analysis, and it can come
into the area of risk assessment just as it
can in any analytical forum. Sometimes
you simply have to act in order to ensure
that local, state, and federal governments
can move forward.
Q
When emotionally charged issues,
such as the threat of cancer or declines
in real estate values, are involved, do
you think that rational public dialogue
on risk is possible?
A
It's not only possible, it's essential if
the public's involvement in the risk
management side is going to be
intelligent, informed, and worth anything
to us. It is extremely hard to
communicate these risk assessment
judgments to the public, because the
public does not react well in the face of
scientific uncertainty. They tend to
believe that we really know what the
problem is and that we just won't tell
them.
Q
Wasn't this the problem you faced
concerning the smelter in Tacoma,
Washington?
r\ Exactly. When the residents of
Tacoma first heard about the
uncertainties associated with our risk
assessment of arsenic, they became
angry, suspicious, and, in some cases,
outspokenly hostile. But after we spent
literally weeks being as open as we know
how to be about this risk, and
communicating it to them, and they saw
the kinds of steps that it was possible to
take to reduce the risk, they then moved
toward a consensus that we should
reduce that risk as much as possible and,
at the same time, permit the smelter to
continue to operate.
\j. How much does public involvement
mean in your decision-making?
r\ The public input will be weighed
very heavily in certain cases. In Tacoma,
the health impact was almost exclusively
local; beyond a certain circumference
around that plant, the population's health
was essentially unaffected. In many
cases, the people within that
circumference were also affected
economically. Therefore, "How do you
DECEMBER 1984
-------
believe this balance should be struck?" is
a very logical question to ask these
people. Nobody has a bigger stake in
that question than they do.
The judgment is mine. But I weighed
heavily what the people of Tacoma
thought, simply because they have a
large and identifiable stake in the
outcome of my decision.
Public involvement is much more
difficult to get on a national scale. Where
I have a decision that affects the whole
country, such as setting an ambient air
quality standard, I tend to fall back on
more general principles. I do weigh the
public input, but I don't give it as much
weight as I would when the effects are
mostly local.
Q
What is the agency doing to create
trust and understanding between the
public and EPA?
A\ The only initiative that will work is
openness. We simply lay out, for
everybody to see, the factors we take
into account in arriving at a risk
assessment and the criteria we use to
make a judgment as to how that risk
should be balanced against other social
concerns. To the extent that the public
understands what we're doing, they will
give us the benefit of the doubt. To the
extent they think that politics or any sort
of extraneous factor is involved, they
won't trust us.
Q
How close is the agency to your
goal of winning the public confidence?
f\ We're a ways away, and I don't
know that we're going to get to the
ultimate anytime soon. Part of that is
because we've been given assignments
by Congress, in the form of these
abandoned hazardous waste sites, to
deal with a lot of local problems where
the people see no benefit whatsoever in
a balance of a reasonable level of risk
against other social concerns. There's
essentially no cost to those people to go
to zero risk: the cost is borne by the
whole society. And the benefit in going
to zero is great for the local population.
This creates constant pressure on the
agency to act in ways that are
inconsistent with the broader definition
of the public interest that we're assigned
to pursue; and it puts us, in many
respects, into an irreconcilable conflict.
And that ensures that our
trustworthiness, wisdom, and objectivity
will be constantly attacked by those
affected.
Q
What future do you see for the
implementation of risk assessment and
risk management concepts?
f* I hope, as we get these hazardous
waste sites cleaned up to a reasonable
level and some of the public outcry
subsides, that we would see our
statutory base encompassing the
distinction between risk assessment and
risk management. Likewise, I'd like to see
that same formulation applied to all risk
management activities within
government. If that were done, then I
think there would be a greater likelihood
that the public would understand what it
is we are trying to do in both assessing
and managing risk and, thereby, accept
that the government was acting in the
broad public interest.
Q
Is trying to harmonize risk
assessment and risk management
practices among federal and state
agencies a major agency concern?
A
I think it's more a concern of mine
than it is of EPA's. As the administrator
of this agency, as somebody working
within a governmental complex that
involves more than one effort to manage
and assess risk, I think it's my
responsibility to ensure that that
consistency across the government takes
place. To the extent that I can advance
that possibility, I think I will have
contributed a considerable amount in my
current role.
Q
Do you have anything that you
would like to add?
*"» Only that I think that it is very
useful to use the concepts of the
assessment and management of risk in
determining how we go about dealing
with the myriad of problems that EPA
and other agencies wrestle with in this
country. I underscore "in this country,"
because what we're really about here is
seeing whether free institutions can
successfully wrestle with the
management of risk in the face of
uncertain science, high public emotion,
and disproportionate impact of the cost
of managing that risk. It's an open
question how successful a free society
can be in dealing with these problems.
But I think this country will only prosper
to the extent that we improve our ability
to do so.
It is likely that other free societies
throughout the world will adopt free
institutions if they see that they work
here. Therefore, I think the work that
we're engaged in here is very important,
not only for the protection of public
health and environment, but for the
advancement of freedom in the world. ! ;
EPA JOURNAL
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Strengthening the
Assessment of Risk
by Bernard D. Goldstein
EPA has taken several steps to
strengthen its risk assessment process
by improving the consistency and
technical quality of its risk assessments,
and by narrowing the inherent
uncertainties as much as possible.
When Administrator Ruckelshaus and
Deputy Administrator Aim returned to
EPA, they convened a task force to study
ways to improve the consistency and
technical quality of EPA's scientific
decisions. The task force endorsed the
National Academy of Sciences'
definitions of risk assessment and risk
management and the agency's intent to
honor that distinction. The task force also
recommended the development of
cross-agency risk assessment guidelines
to ensure consistency and technical
quality in EPA's scientific'decisions. It
further recommended establishment of a
Risk Assessment Forum of senior-level
scientists to resolve scientific disputes.
The guidelines were developed by
cross-agency work groups of scientists
skilled in each topic. Then they were
submitted to groups of 10-30 experts in
government, academia, industry, and
environmental groups for comment. The
work groups were chaired by personnel
from EPA's Office of Health and
Environmental Assessment.Office of
Research and Development. The
guidelines define EPA's procedures for
assessing risk in the areas of
carcinogenicity, mutagenicity,
developmental toxicity, chemical
mixtures, and exposure.
The proposed guidelines published in
November are the first product resulting
from implementation of the task force's
recommendations. These five guidelines
are open for public comment for 60 days,
and will be reviewed by the agency's
Science Advisory Board (SAB) before
being issued late in 1985. The agency
intends that they be living documents,
and will continually revise them as risk
assessment approaches change and as
test methods improve. In addition to
these five guidelines, work is continuing
(Goldstein is EPA's Assistant Administrator
for Ri
on guidelines for systemic toxicants (i.e.,
toxicity to specific organs and organ
systems), and on male and female
infertility aspects of reproductive toxicity.
One of the aims of the guidelines is to
promote consistency across EPA risk
assessments by developing common
approaches to risk assessments. Another
aim is to promote quality of the science
in EPA risk assessments by:
• external scientific review of the
guidelines,
• public comment on the guidelines,
• SAB review of the guidelines, and
• establishment of the Risk Assessment
Forum.
The guidelines will:
• explicitly set out EPA's approach to
risk assessments,
• be general enough to allow
appropriate technical judgment, and
• be used by skilled scientists; they are
not cookbook, step-by-step procedures for
non-scientists.
The guidelines should have an indirect
effect on the regulatory process. Through
peer review of the guidelines, together
with uniform application of them across
the agency, EPA's risk assessments will
be more consistent. Risk assessors from
industry, state and local governments,
and environmental groups will be able to
estimate EPA's scientific response to
problem situations. For example, this
could help in:
• planning new products, or new uses
for existing products,
• setting priorities for cleanup strategies,
and
• developing controls for specific point
sources.
The ultimate goal is to have a
common, explicit, consistent, technically
sound approach to risk assessment. This
DECEMBER 1984
-------
•:,4's Analytical Chemistry Laboratory in
Beitsville, Md., chemists Diane Rains
•if Greer conduct an analysis to
determine if the pesticide FOB /s pre:;.
baked food products. 1'he agency has
carried out a ma/or effort to assess and
manage EDB's risks.
does not prevent the risk managers—the
administrators of the laws EPA carries
out—from using the resultant scientific
assessment in ways consistent with the
particular law for which they are
responsible, or from blending legal,
political, economic, or social
considerations into their decisions. The
evaluation of the scientific information,
however, will remain the same.
The next step in strengthening risk
assessment is the establishment of the
Risk Assessment Forum. Although the
guidelines build a framework for
consistency in risk assessment, they are
of necessity general enough to permit
use of good technical judgment.
Therefore, scientists can and will differ in
their evaluations. The Risk Assessment
Forum is a panel of senior
scientists'managers who meet regularly
to resolve scientific disputes. The Forum
provides a mechanism for interchange on
science issues in risk assessment,
advises the Administrator and Deputy
Administrator on precedent setting cases
and important risk assessment issues,
and recommends revisions or updates to
the risk assessment guidelines, as
appropriate.
The Forum is the managerial
responsibility of the Office of Research
and Development, and is chaired by the
Office of Health and Environmental
Assessment (OHEA). It includes scientists
from every part of the agency. As of this
writing, the Forum has delivered its first
report to the Deputy Administrator and
has a half dozen issues under
consideration.
Finally, the risk assessment process
can furnish a research agenda for the
agency. It can do so in one of two ways.
First, individual risk assessments may be
particularly uncertain because of missing
scientific information. Agency scientists
can organize their experiments around
developing this critical information. For
instance, it may involve better
monitoring of exposure to
hexachlorobenzene, recommending an
appropriate new cancer bioassay for
trichloroethylene or perchloroethylene, or
evaluating more completely the
metabolic pathways of a particular
pollutant like arsenic.
Secondly, the risk assessment process
can provide a research agenda aimed at
narrowing uncertainty by doing basic
research to better define and resolve the
factors that give rise to uncertainty.
Narrowing these uncertainties is
important to risk managers and to
society, because cleanup of pollution is
costly. When we are uncertain about risk
assessments,, we tend to err on the
protective side in setting allowable levels.
If we can make our scientific judgments
more accurate and precise, we can learn
just how much control is appropriate,
and, hopefully, save dollars as well as
lives.
I am confident that EPA's new
guidelines will improve the quality of
EPA's science by making our judgments
more consistent and by narrowing
uncertainty as much as is now
technologically possible. However, their
greatest long-term impact may be in
focusing on the remaining areas of
uncertainty, and suggesting areas for risk
assessment research. By using the
guidelines as an outline, we can lay out a
research program that will, over the next
decade, make significant progress in
bringing more certainty to risk
assessment.
I would like to discuss the challenge of
narrowing uncertainty with several
examples. The first has to do with health
risks where we have a sufficient data
base to define some of the specific issues
which have led to the uncertainty.
Because we can pose the specific
questions, much of our needed
knowledge can be obtained through
carefully planned and focused research
over the next decade.
There are several such problems in the
field of cancer risk assessment. Scientists
throughout the world are seeking to
understand the basic mechanisms of
cancer, how and why it starts, and how it
spreads. We cannot predict just when the
research progress that is being made will
be translated into an unraveled mystery.
However, we can identify some areas of
research that will help EPA scientists and
others to better understand the
significance of various data. Two of these
topics include:
• Evaluation of the significance o1
mouse liver tumors. Some strains of
mice used in cancer evaluations
exhibit a high spontaneous incidence
of liver tumors even when there has
been no exposure to chemicals. There
is substantial scientific controversy,
which needs to be resolved, over the
significance for assessment of risk to
humans when mice exposed to
pollutants develop these liver tumors
and no others.
• There is a need to develop
appropriate risk assessment models
to reflect the different biological
mechanisms of cancer. We currently
use one risk extrapolation model.
However, we believe there are at
least two steps—cancer initiation and
cancer promotion. We need to
understand these processes and their
interaction, and then develop
appropriate mathematical models for
each of the processes.
EPA currently intends to convene a
workshop to look at this cancer risk
assessment area for purposes of
developing a comprehensive research
program which will help narrow these
uncertainties.
The above relates to the hazard
assessment aspects of risk assessment.
Let me also discuss another component,
exposure assessment. Currently, EPA
EPA JOURNAL
-------
exposure analysis is based on available,
usually limited, ambient monitoring data
coupled with use of computer estimates
of pollutant dispersion. Improving the
quality of our data collection and the
sophistication and reliability of these
dispersion models will improve our
knowledge of whole body exposure, but
not of the effect of these doses on the
organs at risk. An emerging research
area is that of biological dosimetry. We
must develop in vitro or external test
systems which properly evaluate dose
response relationships at the affected
organ. Then from improved exposure
estimates and metabolic information, we
can estimate more precisely the amount
of pollutant invading the liver or the lung
or other affected organs. The product of
these two efforts is more precise
knowledge of the relationship between
ambient exposure and health effects.
Often our research data base is more
limited, and we are not as able to ask the
right questions and pinpoint our
research. Many of these are non-cancer
related problems in which the agency's
efforts are much newer.
One of these newer areas of interest is
assessment of mutagenicity, i.e., the
likelihood of a pollutant causing changes
which can then be passed on to future
generations. Until recently, mutagenicity
experiments had been used primarily as
screening indicators of potential
carcinogenicity. More recently, we have
become interested in mutagenicity as a
health effect, per se. We have knowledge
of many test systems which exhibit
mutagenic effects, but we are less
confident of their relevance for
evaluating the potential for creating
human defects that can be passed from
generation to generation. EPA's proposed
guidelines are steps in that direction, but
much basic research still needs to be
done to establish that link with certainty.
Similarly, much more information is
needed to understand and assess chronic
systemic toxicity due to pollutants. These
include cardiopulmonary disease,
immunotoxicity, neurobehavioral toxicity,
and liver and kidney toxicity. Little
information exists about specific toxic
effects, let alone the uncertainty of the
risk assessments. Prime examples are the
potential effects from low dose, long-
term exposure. Because of the historic
focus on cancer and on acute short-term
effects, this area has had little research.
For instance, we have much data on
the acute reversible respiratory effects of
the criteria air pollutants (the six major
air pollutants EPA regulates); in fact,
much of our information here is based
on human experimentation, precisely
because the effects are acute and
reversible, and disappear as soon as the
exposure is reduced. We do not know,
however, whether long-term low-dose
exposure causes iong-term effects, e.g.
emphysema, or leads to secondary
disease, e.g. increased respiratory
infection.
These, then, are our steps for
strengthening risk assessment:
development and use of risk assessment
guidelines, establishment of a Risk
Assessment Forum to resolve scientific
disputes, and use of our risk assessment
experience to establish a research
agenda for acquiring risk assessment
information and developing new risk
assessment methods. As this occurs,
EPA's established reputation for scientific
quality in decision-making and
pioneering in risk assessment will further
improve. There can be no better legacy
for a scientist in a regulatory agency. [ .
DECEMBER 1984
-------
Making Decisions About Risk
by John Moore
"Oo what are you gonna do about it?"
OThis statement—part question, part
challenge, and part cry for help—goes to
the heart of the risk management
decision. In general, once the risk
assessment procedure has resulted in
some estimate of the potential dangers
associated with a specific situation, the
decision as to the appropriate course of
action still remains to be made. Or as
someone has said, "Now comes the hard
part."
I would like to discuss the risk
management process from the point of
view of someone who has sworn to use
the legislative authorities at his
command to protect public health and
the environment from "unreasonable
risk" (in the language of TSCA, the
Toxics Substances Control Act) and from
"unreasonable adverse effect" (in the
language of FIFRA, the Federal
Insecticide, Fungicide and Rodenticide
Act). Furthermore, risk management
activity is carefully constrained by the
specific legislation applicable to any
given circumstance. Although the
process will be somewhat different for
EPA risk managers who administer other
laws, such as the Clean Air Act and
Superfund, many of the elements and
concepts are common to all risk
management decisions.
Definition
and Operation
The flow diagram illustrates the
conceptual framework in which we
consider risk: how to estimate it and
decide what to do about it. Risk
assessment involves the elements
included in circle A: hazard identification,
dose-response assessment, exposure
assessment, and risk characterization.
Risk management involves the elements
included in circle B: risk characterization,
non-risk aspects, and the final decision
on "unreasonable risk."
The need to determine the
"unreasonableness" of the risk/adverse
effect involved distinguishes FIFRA and
TSCA as "risk/benefit statutes." That is,
risk of some magnitude is not sufficient
to justify action. Non-risk factors—such
as the availability arid effectiveness of
controls, the existence of alternatives,
and any benefit that would be lost as a
result of control—must be considered in
the process of reaching a decision. In
'.nor for
Substances.)
some cases, the weighing of the risk and
benefits will be such that the benefits
outweigh the risks. In such a case, the
risk management decision would be to
take no regulatory action. In other cases,
the risks are such, relative to the benefits,
that the reasonable thing to do is to take
action to reduce the risk. As the diagram
illustrates, this decision feeds back to
earlier elements in the framework,
usually resulting in a reduction in the
exposure to the extent that the risk is put
back into balance with the benefits.
Both FIFRA and TSCA present a range
of control strategies to the risk manager.
For example, a pesticide can be declared
a "restricted use" pesticide, which means
that in order to use the chemical, a
person must first have taken a course
designed for pesticide users. The special
training focuses on the proper methods
for handling these materials so that
human and environmental exposure is
minimized. Therefore, the most important
uses of the pesticide are retained, since
someone who thinks using the pesticide
is important will take the course. Other
possible controls authorized by FIFRA
include cancellation of registrations for
some or all uses, lowering of tolerance
levels on food crops, restrictions on
levels of impurities in the product, and
formulation or application restrictions.
The array of control options available
under TSCA includes banning, labeling,
formulation controls, geographic
controls, process quality controls, and
record keeping. The legislation instructs
the decision maker to choose the least
Circle A
Dose-Response
Assessment
restrictive control that will reduce the risk
to a level which is not unreasonable.
The risk management process usually
involves more than one decision. This is
because the degree of risk often varies in
the different phases of product use. For
example, pesticide "X" is capable of
being absorbed through the skin and
causing damage to the kidneys, that is, it
has hazard potential. Further, the doses
that can cause this effect are quite low. In
evaluating its method of production and
use there are four areas where exposure
may occur—when the chemical is made,
when it is mixed and applied, when a
vegetable is picked, and when it is eaten.
Since the chemical is rapidly destroyed
by sunlight, the level of exposure during
picking and eating is practically zero, so
no risk management issue is involved.
Exposure during manufacture of the
chemical is kept to acceptable levels
because the manufacturer plans to use a
method of production that is totally
enclosed. Exposure during mixing and
application of the liquid pesticide
approaches levels that may cause kidney
damage. However, it is known that the
chemical can be made in a granular as
well as the originally planned liquid form.
In this form, absorption through the skin
is decreased 500-fold. The risk
management decision is to deny use as a
liquid, and permit use in a granular form.
This risk management decision only
could be reached because one was able
to reduce the exposure part of the risk
assessment equation. There might also
be two other risk management decisions
associated with this theoretical pesticide:
prohibit entry for 1-2 days immediately
following treatment of the vegetable field
and require harvest intervals between the
date of last treatment and harvest. These
actions would be to ensure breakdown of
the pesticide prior to harvest and
consumption.
RM
Characterization"
Regulatory
Decision
_^ Non-Risk ^T /
Analyses /
Contr&l /
Options
*
i __
i_ rrrrr.
i 1
Risk Assessment and Risk Management
8
EPA JOURNAL
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The regulation of polychlorinated
biphenyls (PCBs) further illustrates
important aspects of risk management.
PCBs are chemicals which have
significant benefits when used in certain
large pieces of electrical equipment (like
transformers), found in most large
buildings across the country. Because
PCBs also happen to be toxic, very
persistent (long-lived once they get into
the environment), and tend to
bio-accumulate in fish and other food
sources, Congress decreed in the original
TSCA bill in 1976 that PCBs should be
banned.
Consequently, EPA has been
implementing processes that remove
PCBs from our environment. These
chemicals are no longer produced or sold
in this country. The agency has issued
regulations designed to ensure that PCBs
are disposed of without generation of
unreasonable risks.
In 1979, we began permitting the use
of high temperature incinerators to
dispose of PCBs. Careful EPA
investigations revealed that the emission
of chlorinated dibenzo-p-dioxins (CDDs)
and chlorinated dibenzofurans (CDFs)
was associated with the incineration of
PCBs. Among the CDDs/CDFs formed
was the notorious 2,3,7,8-
tetrachlorodibenzo-p-dioxin (2,3,7,8-
TCDD), which has gained fame as a toxic
contaminant of the herbicide Agent
Orange and is the subject of a 1984-85
study by the agency to determine the
extent of contamination at a variety of
sites in our country. The chemical is
sometimes loosely referred to as
"dioxin." The hazard identification and
dose-response assessment case for this
compound were well established.
The agency conducted a series of
emissions tests during PCB incineration
to determine the extent of human
exposure in neighborhoods near the
incinerators. The study revealed that
something like one tenth of a millionth
millionth of a gram would be inhaled
daily by a person under the worst case
conditions. The risk characterization
associated with this extremely low level
of exposure was so small compared to
Harvesting gr.i:
risk management decisions regarding the
use of pesticides on fruits and ve& I
non-risk factors like alternative methods
of disposal (e.g., land disposal or
"midnight dumping") that the benefits of
incineration were judged to outweigh the
exposure risk; the risk management
decision was to approve incineration as
an appropriate method for disposal of
PCBs.
The decision not to take regulatory
action in this case does not mean,
however, that there are no
"unreasonable risks" associated with
PCBs. In recent years we have learned
that when PCB-containing transformers
and capacitors are involved in building
fires, the production of "dioxin"-like
compounds can result in cleanup costs
that run into the tens of millions of
dollars.
This PCB case differs from the
incineration situation primarily in the
exposure assessment. Smoke from low
temperature, low efficiency building fires
can lead to much higher acute and
chronic exposures to combustion
products than can the very low levels
emitted from high temperature, high
efficiency incinerators. Therefore, I have
reached the risk management decision
that the risk related to PCBs involved in
building fires is unreasonable and should
be brought back into balance with the
benefits of continuing to use PCBs until
the equipment can be replaced.
After considering the costs involved, I
am recommending that we introduce a
series of control options ranging from
isolating this equipment from the
building ventilation system to marking
the buildings so that firefighters will be
aware of the special nature of the fire
that may be burning within.
Conclusions
The activities leading to characterization
of risk are more fraught with
assumptions and subjectivities than one
would like. Similarly, the methods
available for analyzing the non-risk
factors in a quantitative manner are
weak. Therefore, risk management
decisions are anything but
"cut-and-dried." But then, that's the way
it is with risk assessment/risk
management...not predictable perhaps,
but always interesting!
Risk managers need to use their best
judgment, carefully weighing all the
factors, and make what is often a very
difficult decision that will affect millions
of citizens. As one of those risk
managers, I can only promise you that in
this process I do my best to assure that
human health and the environment are
protected from unreasonable risk. [ i
DECEMBER 1984
9
-------
Helping the Public
Weigh Health Threats
By Josephine S. Cooper
•
(Cooper is EPA's Assistant Administrator for
External Affairs.)
The head of an intelligent corps of
scientists, engineers, and managers,
whose mission is to protect people and
their surroundings, stands before a bank
of television cameras and asks the nation
to "calm down."
"We have a problem, but it is not one
of monumental proportions," he reports.
"It's a chronic circumstance—one we can
deal with in an orderly fashion without
going into a panic and disrupting our
lives and our economic stability."
This in essence is what EPA
Administrator William D. Ruckelshaus
said on February 3, 1984, when he
opened a press conference to announce
actions EPA was taking to protect the
people from ethylene dibromide—EDB.
It sounded like a rather simple
message. At the beginning it was.
It was followed, however, by
information that was highly technical. It
included recommendations for maximum
allowable residue levels at specific parts
per billion in raw grain, in products made
with processed grain such as flour and
cake mixes and, finally, in ready-to-eat
foods such as bread and cereal.
It was so technical that no housewife
or store owner or grain elevator operator
in the country could have gone to the
cupboard, or the shelves, or the grain bin,
and figured out what had to be thrown
out and what coutd be kept.
It was technical because, of the
thousands of words used to describe the
outcome of the risk assessment process,
the only ones that carried a commonly
understood message were flour, cake
mixes, muffins and CANCER. And it's
hard for many people to calm down
when they see experts discussing a
relationship between the foods they eat
every day and CANCER.
Still, the broadcast was one of the most
successful efforts to date to communicate
with the American public about risk. It
was successful perhaps because an
individual with recognized credibility
stood before the people and gave them a
personal assurance that they could
relax—that they could "calm down."
Clearly communicating risk is one of
the ultimate challenges we face.
Administrator Ruckelshaus, in speeches,
in reports, and in interviews, has pointed
out the need to find ways to explain risk
"in terms that the average citizen can
comprehend."
When dealing with matters affecting
the environment and public health, our
society through its laws has decided the
public must be involved more than ever
before in history in the decision making
process.
We need, Ruckelshaus points out,
public understanding so people can
participate effectively in the
decision making process; and,
conversely, they need a government that
EPA JOURNAL
-------
speaks in language they understand so
they can join in the dialogue.
In the end we may find it impossible to
communicate, to scientists' satisfaction,
the nature and degree of risk to a public
not sophisticated in the conventions of
risk assessment methods and risk
management decision making. We can,
however, give people the facts they need
in a form they can understand so they
can follow and participate in the process
and act in a rational way.
The question is: how do we address
the problems of risk communication
without giving an impression that we are
trying to manipulate the public instead of
bringing it into a full partnership role in
this process?
First, it is critical to recognize that risk
assessment and risk management are
fledgling sciences. With microscopes,
spectrographs, and sophisticated
calculations, scientists weave a cloth of
uncertain threads. The blanket they
produce is supposed to offer the public
security—security based on uncertain
beliefs in uncertain risks with uncertain
solutions.
Communicating the result of this
complex effort means communicating
uncertainty. Yet social psychologists such
as Paul Slovic point out with well-
documented research that people fear
most the things they don't understand,
can't see, and can't control. In short, the
thing they fear most is uncertainty.
Of course, those in the business of
measuring risk and trying to
communicate it want a different kind of
response. They want the public to see
that inherent in the process are complex
hazard identification steps: studies of
dose-response relationships, exposure
assessments, and analyses of risk
exposure channels. The results of these
steps are then expressed in conservative,
probabilistic outcomes, still containing
uncertainties.
Furthermore, they want the public to
see the importance of balancing various
risks in a risk management process that,
depending upon the risk involved and the
legislative dictates for how such risks are
to be handled, analyzes alternative
actions in the context of complex
analytical tools called risk-benefit,
benefit-cost, and cost-ettectiveness.
Scientists are coming to know the
precise meaning of these terms of art.
But the general public—people worried
about whether or not they should feed
their children cereal in the
morning—hasn't the foggiest notion what
these terms mean. While people may not
be averse to accepting risk, they want to
be able to understand and have some
choice regarding the risks they accept.
The second step we must take if we
are to succeed in meeting the risk
communication challenge is to look at
what we have been doing and candidly
test the results.
In the EDB case, the Roper organization
asked some questions in their periodic
surveys that would test the public's
reaction to EPA's communication effort.
They had heard Mr. Ruckelshaus say,
"Calm down." How had they reacted?
The returns indicated a total of 33
percent of those polled said EPA acted
"very responsibly," while 26 percent said
the state governments acted "very
responsibly." EPA got a stronger vote of
confidence despite the fact that some
states had gone beyond the EPA
guidelines in setting allowable residue
levels. The only group ranked higher in
the public's eye was the supermarkets.
People in this group, whom the public saw
actually removing food from shelves as a
protective step, were given a 37 percent
confidence rating.
Another analytical effort now being
carried out by consultant Harold I.
Sharlin looks at the EDB event and asks
exactly what EPA was trying to
communicate and how well it succeeded.
Sharlin's work indicates that, like
two trains safely passing in the night, the
agency and the public were traveling on
separate, albeit parallel, tracks.
EPA was sending out messages about
risks to the public at large while John
and Jane Citizen were sitting at home
waiting to hear whether or not their
cupboard should be cleaned out. In
Sharlin's words, EPA was talking about
"macro risks" while the people wanted to
know about the "micro risk"—the risk to
them personally and to their families.
In the national print media, EPA efforts
to communicate were received and
presented to the public in the
sophisticated, analytical "macro risk"
form.
In local newspapers and in television
reports, however, the message was
confused as reporters and commentators
searched in vain for solid, salient quotes
about the micro risk—the risk the
individual faced from eating an
EDB-contaminated bran muffin for
breakfast in the morning.
The third step in meeting the challenge
we face in risk communication then is to
find a way to fill the need for micro risk
information so people can understand or
at least get some idea of what the risk
means to them so they can participate in
the dialogues and act in a rational
manner.
Some new measures, simpler
techniques, or perhaps some better
words or symbols would help. Many
scientists, however, respond that their
work is too complex or complicated to
communicate simply. Communicators, on
the other hand, might suggest that this
response is a modern-day "cop out."
Something of the same dilemma
existed in another scientific area back in
the 1930s. People were designing
buildings, roads, and dams, and making
risk management decisions by juggling
complex sets of information on a range
of geological variables.
One scientist, however, came up with a
logarithmic scale ranging from one to
ten, that has since been used to express
the magnitude of total energy released
by a sudden geologic shift—information,
incidentally, that is used to communicate
future risk to people and structures. It is
known as the Richter Scale. "One"
means a slight tremor, while a "ten"
means disaster. Not only did his
colleagues understand the measure; so
did the man in the street.
The U.S. Forest Service offers another
example. When you drive into a national
forest you pass a sign on the side of the
road with five colors on it—red, orange,
yellow, green, and blue. An arrow points
to one of the colors. If it points to red
you learn immediately—while traveling at
55 miles per hour—that the risk of fire is
too great to allow you and your family to
have a campfire that evening. The risk is
assessed and, once assessed, is
communicated almost instantly.
The average citizen is also accustomed
to dealing with risk in the context of the
weather and, in some cities, air pollution
indices. A 50 percent chance of rain may
mean Joe takes a raincoat to work with
him. The main point is that risks can be
communicated and people can make
responsible decisions on how to deal
with them.
Of course, from a pure communication
perspective, it doesn't take a marketing
genius to recognize that consistency in
use, repeated exposure, and easy
understandability could be keys to
success.
People respond to fear as scientists do
in the risk assessment business when
faced with conflicting data and
uncertainty. They feel a duty to stack up
conservative assumptions—better to err
on the side of conservatism when
dealing with a macro risk to public
health. Likewise, when protecting
themselves and their children, people
want to err on the side of safety. This
means they too are going to go with the
most conservative assumption, or
statement, on the market. In short, they'll
believe the widely broadcast worst-case
scenario.
To communicate risk we perhaps need
to collectively search for ways to do so
conceptually just as Richter did, just as
the forester does, just as others have. We
need to talk simply to people, and we
need to find ways to answer their
questions.
It can be done. It will simply take
creative concentration. D
DECEMBER 1984
11
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Some ABCs
in Addressing
Risk
by Bob Burke
EPA is forging an integrated strategy
for assessing and managing risks
because the major health and
environmental challenges the agency
now faces from heightened public
concern about toxics issues are more
complex and more subtle than those it
confronted at its inception in 1971. This
article briefly describes these challenges
and the risk assessment approaches EPA
is developing to address them.
The Toxic Chemical
Challenge
There are four distinct yet interrelated
problems associated with health and
environmental risks from toxic
substances which must be addressed by
an integrated risk strategy.
Numerous and diverse toxic wastes:
More than 65,000 industrial chemicals
have been produced since 1945. Several
thousand of these demonstrate various
toxic effects or exist in sufficient volume
to be of concern.
Elusive hazardous substances:
Hazardous substances often do not
respond to actions that are meant to
isolate or destroy them. The task of
keeping tabs on the movement and safe
disposal of persistent pollutants is
complicated by the fact that they can
often produce health risks at exceedingly
small concentrations.
Varying mandates on toxic substance
risk: The issue is complicated by the fact
that EPA is regulating toxic substances
under no fewer than eight different
legislative acts. Each statute has resulted
in the establishment of independent EPA
programs with different risk requirements
and mandates. Some require or allow
EPA to base regulatory decisions on risk
reduction, while others are based solely
itturko IS on tin: shitf a! the I PA Office of
Piittht: 4,',',K/.x I his mild'. ••! primarily
on ,) :;uon tu i>c pul I itled
R;sk Assessment and Hisk N'
• .'!)/ [ PA's Toxic !<,;•. i;'.'''on
^ / tl'Cf I
on employing the best available control
technology to reduce toxic pollutants in
the environment.
Dealing with internal integration:
Legislative and program differences have
often led to different risk assessments
within EPA for the same substance. Risk
decisions must be integrated to prevent
transfer of pollution from one medium to
another (i.e. from air and water to the
land), and to prevent the duplication of
research on essentially the same
chemical or set of chemicals. The
strategy for integrating risk assessment
isn't intended to abrogate these
legislative responsibilities. But it does
seek to strengthen the credibility and
coherence of what EPA says about the
risks of individual toxic substances to
reflect the harm they cause to health and
the environment, independent of whether
they did it through air, surface water,
drinking water, or the land. Most people
probably don't care as much about the
medium a chemical traveled to get to
them as they do about the risks it poses
to their health, and what can be done to
identify and reduce these risks.
EPA is working to achieve this risk
assessment process through two sets of
steps. The first involves the confirmation
of a logic for assessing risks. The second
is to strengthen certain risk assessment
guidelines pertaining to specific adverse
effects of toxic chemicals.
Risk Assessment
Logic
The logic that EPA is employing to
integrate the assessment of health
involves a four-step process that can be
framed almost as a set of questions to
which answers are sought.
1. How hazardous is the substance? This
first step involves weighing available
evidence to determine if a particular
chemical substance has the inherent
capacity to cause harmful effects. This
analysis is wholly independent of how
much of the substance is involved or
whether any living thing has had contact
with it. The substance could be located in
somebody's backyard or in the safest
confines of a laboratory.
2. How much is harmful? If the substance
is likely to cause a particular effect, it is
then necessary to know how potent it is.
This step looks at the risks posed by the
substance at various levels of exposure.
For example, both saccharin and dioxin
cause cancer in animals, but it takes
literally millions of times more saccharin
than dioxin to produce equivalent effects
in laboratory testing.
3. What is the nature of the exposure?
The next step is to estimate the nature of
exposure in terms of how many people it
affects and the time span in which this
exposure has occurred. For many
substances and incidents, exposure
analysis involves an entire population of
consumers who have been exposed over
several years. For others, a shorter-term
focus involves the maximum level of
exposure on people living near a specific
source.
4. What are the risks in a particular
situation? The final step in the risk
assessment logic focuses the preceding
factors to determine the actual risks of a
certain substance in a particular
circumstance. This process considers the
strengths and weaknesses of all the
evidence and recognizes that the
assumptions which go into assessing
risks invariably have individual and
collective margins of error.
There may always be uncertainties
about the environmental and health risks
of a toxic substance even when
legislative deadlines and regulatory
mandates require that some decision be
made about controlling its use or
presence in the environment. It should
also be clear that the risk assessment
A risk assessment process may consider
health threats to special segments of the
population such as children, the elderly,
people with respiratory disease, or pregnant
women.
12
EPA JOURNAL
-------
logic described earlier is simply what its
name implies. In the case of risk
assessment, this logic must be
supplemented with methods for
evaluating specific adverse health effects
and the conditions under which they
cause risk. This is why EPA is proposing
new guidelines for risk assessment or
proposing amendments to the ones it
already has. These guidelines are being
proposed to standardize the scientific
assumptions used, and therefore to aid in
improving consistency and credibility in
risk assessment.
Risk Assessment
Guidelines
EPA's risk assessment guidelines are
aimed at improving the consistency and
technical quality in assessments of
human health risks from the thousands
of toxic substances under the agency's
purview. The six risks are:
1. Cancer: That certain toxic substances
cause cancer and that others may do so
is no longer seriously questioned within
th§ scientific and health community.
Guidelines developed in 1976 to assess
these risks are being updated to reflect
more recent knowledge about the causes
of cancer and recent developments in
methods for assessing cancer risk.
2. Mutagenicity: Mutagenicity refers to
the potential of an agent or substance to
induce alteration in the genetic material
of living organisms. Until recently,
mutagenicity information was used
exclusively to predict the potential for
cancer. In 1980, EPA proposed guidelines
for assessing mutagenic risks as health
effects, per se. These new guidelines are
an update of the 1980 proposal.
3. Reproductive effects: The male and
female reproductive systems and the
developing fetus are potentially sensitive
targets for the action of toxic agents.
Birth defects research includes an
extremely diverse set of impacts, and
there have not been any previous risk
assessment guidelines published for this
class of effects. Guidelines for assessing
risks to developing fetuses were
proposed in November 1984. Work on
guidelines assessing male and female
fertility effects is just beginning.
4. Systemic effects: Exposure to toxic
substances can also lead to adverse
health effects on other organs of the
body such as the liver, the kidneys, or
the lungs. These effects can range from
very minor impacts to severe organ
dysfunctions, physical debilitation, and
even death. Because of the number of
toxic effects and organ systems involved,
work on this guideline has been slower.
It should be proposed next year.
5. Assessment for chemical mixtures:
Most risk assessments address the health
impact of individual chemicals, but EPA
has a need to know what happens when
people have been exposed to a mix of
chemicals since this is often what
happens in the real world. The new
guidelines will include procedures for
assessing the risks from exposure to
chemical mixtures.
6. Exposure assessment: As noted
earlier, decisions on controlling toxic
substances must often be made in the
absence of complete environmental data.
As such, the decision maker must often
make a risk assessment based only on
estimates. What tools can be used or
developed to make these estimates as
accurate as possible? The new risk
assessment guidelines tell what
information is needed for exposure
assessment, and articulate a format for
reporting this information. The guidelines
also propose a method for estimating
and reporting uncertainties in exposure
assessment.
A Word About
Risk Management
An integrated risk assessment process
can organize the scientific information
needed to make regulatory decisions
about controlling substances, but it can't
make these decisions. Judgment is
needed to integrate risk assessment with
economic and financial considerations,
considerations of feasibility, and
"common sense."
This is where risk management comes
into the equation. Risk assessment and
risk management are two distinct though
complementary parts of the regulatory
decision process. Risk assessment is the
process used to estimate risks to public
health. Because of the uncertainties in
currently available scientific information,
the agency estimates risk conservatively
and reports that estimate as an upper
limit of hazard or virtually safe exposure
level together with estimates of increased
risk, if measurable, from higher exposure
levels. Risk management then looks at
the economic and social implications of
each level of protection.
Therefore, EPA's objective is not to join
risk assessment and risk management
but to clearly separate the two so that
scientific judgments comprising risk
assessment can be made independently
and then balanced against the economic,
social, and community considerations
that might be adversely affected by any
decision addressing the risks involved. !
DECEMBER
-------
Controlling the Dangers
from High-Tech Pollution
by Judith E. Ayres
This is the fourth article in a series by
EPA's regional offices on major
environmental problems they are
addressing. The topics of the articles
have ranged from efforts to clean up
Boston Harbor pollution to the
involvement of the public in protecting
the Biscayne Aquifer in Florida. Ayres is
Regional Administrator of EPA Region 9.
How can risk assessment and risk
management best be used to address
actual environmental problems? EPA is
now engaged in a special project in the
Santa Clara Valley of northern California
to explore this question. The agency's
Integrated Environmental Management
Project, conducted in close cooperation
with state and local governments,
industry, and environmental groups in
the area, is designed to help officials at
all levels of government manage the
complex problems of toxic substances in
the air, surface water, ground water, and
land of the Santa Clara Valley.
The Santa Clara Valley is better known
as Silicon Valley, a remarkable center of
high-technology manufacturing which
has become the symbol for our national
industrial renaissance. In the past twenty
years, hundreds of electronics,
semiconductor, and computer firms have
located here—or have sprung up from
the inventiveness of local engineers.
Today, Santa Clara County is one of the
fastest-growing areas of the country, and
San Jose, once a sleepy orchard town
and now a center of the high-tech
development, is one of the nation's
fifteen largest cities.
All of this industrial activity is hard to
notice, however. Driving from Stanford
University in Palo Alto to the green hills
east of San Jose, one sees no
smokestacks at all, and hardly anything
that even looks like a factory.
Semiconductors and electronics
components are made in campus-like
buildings interspersed with housing. The
air above San Jose is clear, except for
occasional smog from the ever present
autos; the industries that dominate the
area have a long-standing reputation for
cleanliness. It is largely due to Silicon
Valley's reputation that state and local
governments all over the country have
been encouraging similar developments
within their borders.
Recently, however, it has become
obvious that the absence of smokestacks
does not mean an absence of
environmental problems. The industry
uses a wide variety of solvents and other
organic substances and these have been
leaking from underground storage tanks
so as to threaten the Valley's drinking
water aquifers.This has generated
widespread public concern, and resulted
in a reassessment of the industry's
impacts on the environment. These
contamination incidents have also,
unfortunately, led some elements of the
press and the community to overstate
the magnitude of the environmental
health problem: "high-tech toxics" make
best-selling headlines.
EPA responded in 1984 to the
immediate threats to the area's ground
water by adding 19 sites in Santa
Clara County to Superfund's National
Priorities List. The agency was involved
in the area even earlier through its
Integrated Environmental Management
Project (IEMP). This innovative project
uses state-of-the-art techniques of risk
assessment to define risks to public
health from exposure to toxics in the
Valley. These assessments will then be
used to develop strategies to manage
those risks more effectively.
This project is a joint effort of Region 9
and the Office of Policy Analysis at EPA
headquarters. It embodies three of the
agency's central principles: the
separation of science from political
concerns in order to guarantee sound,
credible risk assessment; the use of risk
management to make sure that we are
reducing risk the furthest where it
threatens us most; and a firm
commitment to doing the public's
business in a public way.
For risk assessment, this means
considering exposures to toxics in a
highly site-specific context. The agency
has learned in recent years that the
nature and magnitude of toxics problems
vary widely from place to place,
depending on local hydrology,
meteorology, industrial patterns, and so
on. This is nowhere more obvious than
in Silicon Valley, where futuristic
manufacturing processes present
problems far distant from those of
smelters and steel mills. The
hydrogeology of the Valley, too, is like
that of few other places in the country;
ground water here moves at several feet
per day. The routine application of
national models will not do. Through a
detailed case study of a particular area,
however, we can take those site-specific
factors into account.
The IEMP also aims explicitly at
comparing the risks from toxics problems
in all environmental media—air, surface
water, ground water, and land. Public
attention in the Valley has been riveted
on ground water, yet half of the Valley's
population drinks surface water imported
from elsewhere in the state. Are our
surface water problems just as serious as
those from ground water, in terms of
their impacts on human health? How are
the relative risks from surface and
underground supplies likely to vary in the
years ahead? What about toxic air
pollution? We don't currently know the
answers to these questions. But we are
finding out. Without this kind of
comparison of risks, we will never know
whether we are spending our resources,
those of state and local governments,
and those of the industries we regulate,
in ways that buy the most public health
protection for the money we collectively
spend.
Ways to achieve those larger payoffs
will be the focus of the second stage of
the project, which is scheduled to begin
in January 1985. For any given problem,
we can apply any number of "fixes"; the
question is which will do the most good.
In the case of ground-water
contamination in the Santa Clara Valley,
we can apply tighter controls on new or
existing underground tanks. We can
require more monitoring around the
tanks, so as to catch any spills before
they escape to the aquifer. We can
contain and clean up certain spills. We
can impose tighter controls on other
possible sources of ground-water
contamination, such as pesticide
application, or landfills, or sludge
farming. We can monitor the drinking
water wells more frequently and more
closely. We can even institute treatment
of ground water, parallel to the ways that
surface water is now treated. Which of
14
EPA JOURNAL
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TOXIC SPILL SITES
IN SUNNYVALE *ND
MOUNTAIN VIEW G*« V
these options, or what combination, will
reduce risk the most? At what cost? At
whose cost? These are some of the
questions the IEMP will answer in Santa
Clara. Again, the answers must be
site-specific, because no real problem fits
the national average case.
An undertaking like the IEMP could
never succeed without the active
involvement of state and local agencies.
In the Santa Clara Valley, we are working
with upwards of a dozen such bodies,
sharing data, expertise, and insights on
the problems. In an important sense, the
project is an experiment in a new
partnership of federal, state, and local
governments, in which true cooperation
and collaboration replace traditional
delegation and oversight. The results, so
far, are extremely encouraging. "Getting
people to sit down at the table" and
"sharing data among agencies" are two
of the oldest chestnuts in government,
but the dividends are enormous when
the cooperation is real and continuous.
Our efforts in this regard are supported
from the very top of the local
government structure. At its outset, the
IEMP established an Intergovernmental
Coordinating Committee, consisting of
county supervisors, mayors, city council
members, and members of the elected
boards of regional regulatory agencies.
The committee meets once a month with
EPA staff to discuss the progress of the
project, to suggest modifications and
new directions for the work, and to
ensure that the project remains useful
not only to EPA but to the local
governments and regional agencies in
whose communities we are working.
Their support has been indispensable to
the project.
If improved ties among various
agencies of government are crucial to the
lEMP's success, so is the active
involvement of the public. We have been
fortunate, in the Santa Clara Valley IEMP,
to work actively with industry, with the
U.S. '•'
ansiA
.
leaders of the environmental community,
and with the universities whose presence
helped create Silicon Valley in the first
place. Once a month, EPA staff meets
with the lEMP's Public Advisory
Committee, where these and other
groups offer criticisms and suggestions.
This is no public relations exercise. We
firmly believe that only in the light of
such scrutiny can we develop sound,
defensible strategies for the complex
problems confronting the Valley. And
only if we are open with the public can
we earn the public's confidence.
EPA has not, of course, abandoned its
traditional role in the Santa Clara Valley.
We maintain a strong enforcement
presence, and stand ready to act swiftly
in cases where direct federal involvement
is called for. Our Superfund listings are a
case in point. We will not allow the IEMP
to be used as an excuse for
procrastination where EPA determines
that action is necessary. Analytic projects
like the IEMP were never conceived as a
substitute for active, aggressive
regulatory programs; instead, the two
must work hand in hand.
The IEMP can, however, help us to
achieve several important goals. It will
result in better long-term strategies to
manage environmental risk in the Santa
Clara Valley, strategies hammered out in
conjunction with the state, with local
governments, with industry, and with the
public. It will also, we hope, help EPA
address toxics issues nationally; along
with companion studies in Philadelphia
and Baltimore, the 1EMP sheds new light
on variations in those problems from
place to place, and on flexible strategies
to control risk. Finally, by working toward
the rational solution of the problems
which now confront the Santa Clara
Valley, we are helping to ensure that the
new industrial renaissance, symbolized
by those smokeless factories, wilt not
occur elsewhere at the expense of
human health and the environment. With
the help of our state and local partners,
the industrial community, and the public,
we can ensure environmental health here
in Silicon Valley, and in other Silicon
Valleys not yet built. D
DECEMBER 1984
15
-------
Is Animal Testing
Overrated?
Two Views
by Dr. David P. Rail
Testing the health effects of chemicals
in laboratory animals is an approach in
wide use. How accurately does it
indicate dangers to human health? The
EPA Journal asked two scientists
concerned with the assessment of
chemical hazards to humans to speak
to the subject. Their articles follow.
The first piece is by Dr. David P. Flail,
Director of the National Institute of
Environmental Health Sciences and the
National Toxicology Program. The
second is by Dr. George Roush, Jr.,
Director of Medicine and Environmental
Health for Monsanto, a chemical
manufacturing company.
Modern civilization has learned to
develop methods and to use the
products of these methods to provide for
human sustenance and comfort. This
technology has created tremendous
benefits as well as rapid changes in our
environment. The lifespan of the average
U.S. citizen has increased dramatically in
the last century. While curative medicine
and preventive vaccines played an
important role, the results of
technological innovation have been
critical factors—improved nutrition,
sanitation, shelter, and water supply.
However, this increasingly rapid rate of
innovation and our inability to anticipate
the consequences of these changes
should continue to be cause for concern.
One of the most innovative areas has
been in the chemical process industry,
leading to inexpensive plastics,
agricultural chemicals, etc. These have
contributed to a better, longer life for all
of us. We have come to learn, however,
that some chemicals can act like a
double-edged sword: while most offer
real benefits to mankind, a few can also
pose a threat. Society obviously needs
the fruits of the chemical industry, but at
the same time it needs protection from
those few chemicals that can adversely
affect human health.
The hazards of some of these
chemicals have been well studied. It is
known that many human diseases can be
traced to chemical exposure: male
sterility to Kepone and
dibromochloropropane; neurologic
disease to Kepone, methyl mercury, lead,
and methyl butyl ketone; lung cancer to
asbestos, arsenic, bis(chloromethyl)ether
and others; liver hemangiosarcoma to
vinyl chloride; mesothelioma to asbestos,
etc.
Fortunately, most chemicals are
relatively non-toxic and require few if any
controls to protect human health. It
appears that only a small fraction of
chemicals are highly toxic. Thus, to
protect the public health and to prevent
disease, this fraction should be
accurately identified so that appropriate
methods of control can be considered.
The mainstay of this hazard
identification process is the laboratory
animal toxicity study. A lifetime toxicity
study of experimental animals, usually
rats and mice—beginning at weaning,
ending at death, using multiple dose
levels of the chemical being
tested—provides information on the
kinds of toxic effects caused by the
chemical and the doses or concentrations
causing these toxic effects. This standard
test determines if a chemical causes
cancer and produces damaging effects
on certain organ systems in
animals—liver, lung, kidney, and
endocrine systems. In the absence of
relevant epidemiological'clinical data,
these data typically constitute the
primary basis for human hazard
identification.
Historically, laboratory animal
investigations have provided the basis
for understanding disease processes and
for developing new and better medicines.
It should not be surprising that the
results of toxicological testing in
laboratory animals predict reasonably
well the effects of chemical exposure in
humans.
The molecular, cellular, tissue and
organ functions are strikingly similar in
all animal species; processes such as
Na"1 and K + transport, ion regulation,
energy metabolism, and DNA replication
vary little as one moves along the
phylogenetic ladder. The classic work on
the transmission of neural impulses in
the squid axon is directly relevant to
man. Extensive studies of renal function
16
EPA JOURNAL
-------
After exposure to environmental jyents,
this white tat /s being observed foi
tremors that reveal effects on ••
system Scientists fit the National Institute
of Environmental Health Sciences
developed this observation method ui.
• lastic stand coupled with an
electronic monitoring system.
by Dr. George Roush, Jr.
in fish, rodents, and dogs provide the
basis for current understanding of renal
function and the treatment of
hypertension in man.
As long ago as 1966, Cancer
Chemotherapy Report in Volume 50
described the testing of a series of 18
anti-cancer drugs in laboratory animals
after the toxicity of these compounds had
been determined in clinical trials with
cancer patients. The animal tests
mimioked the dose schedule and route of
administration. The results in mice and
rats showed that the toxicity—essentially
the maximum tolerated dose in
laboratory animals and patients when
expressed on a chemical doses per unit
body surface area basis—was quite close,
generally within a two- to three-fold
range. The greatest differences were
about ten-fold.
The relevance of laboratory animal
toxicity studies as well as carcinogenicity
studies has been extensively considered
and was reaffirmed in the 1977 National
Academy of Science-National Research
Council report on Drinking Water and
Health. Almost all of the known human
carcinogens as defined by the
International Agency for Research on
Cancer (IARC) are carcinogenic in
appropriate laboratory animal studies. In
fact, animal data showing a carcinogenic
response to a chemical have even
preceded human case reports or
epidemiological findings in a number of
instances. Examples of chemicals for
which initial indication of carcinogenic
potential occurred in animal studies
include aflatoxin, 4-aminobiphenyl,
bis(chloromethyl)ether, diethylstilbestrol,
melphalan, mustard gas, and vinyl
chloride.
It is certainly true that not all
animal carcinogens have been shown to
cause cancer in humans. This may be
because we have not yet developed the
epidemiologic or clinical tools we need to
relate disease to a specific chemical
which has been shown to be toxic in
animal experiments. However, most
scientists recognize the importance of
animal data as an indicator of human
carcinogenic potential. For instance, the
IARC has long taken the position, as
stated in its most recent monograph on
the evaluation of the carcinogenic risk of
chemicals to hurnans, that:
In the absence of adequate data on
humans, it is reasonable, for practical
purposes, to regard chemicals for
which there is sufficient evidence of
carcinogenicity in animals as if they
presented a carcinogenic risk to
humans. The use of the expressions
'for practical purposes' and 'as if they
presented a carcinogenic risk'
indicates that at the present time a
correlation between carcinogenicity in
animals and possible human risk
cannot be made on a purely scientific
basis, but only pragmatically. Such a
pragmatical correlation may be useful
to regulatory agencies in making
decisions related to the primary
prevention of cancer.
In conclusion, it seems clear that
laboratory animal data will continue to
play an essential part in identifying the
potentially toxic effects of chemical
exposures and in protecting the human
population from them. In addition, such
data will often be used to confirm the
identification of hazards and support the
findings from epidemiological
investigations. Further, as increasing
emphasis is placed on the question of
biological relevance in assessing possible
human health hazards, laboratory animal
data may provide essential scientific
insight into issues such as mechanisms
of action and effective target dose. Data
emanating from clinical or
epidemiological studies remain the best
indicators of toxicity. However, when
adverse health effects are observed in
humans, it indicates that we have failed
to prevent human exposure, which is the
goal of public health.
Finally, in the absence of relevant
epidemiological data, laboratory animal
studies will continue to offer the primary
means for determining and perhaps
preventing the likelihood of adverse
effects on human health. It is this critical
first step which provides the basis for
effective regulation of hazardous
chemicals and can help to prevent
unnecessary regulation. D
Few recent scientific endeavors have
been subjected to more criticism than
the use of mice and rats in determining
whether certain chemicals may pose a
cancer risk to people. This criticism has
ranged from the highly technical to the
simply ludicrous—cartoons of bloated
rats guzzling hundreds of cans of diet
soft drinks.
All of this attention indicates the
importance of the issue, namely whether
feeding large amounts of a suspect
substance to several hundred test
animals for two years, then probing their
organs for cancer, can tell us anything
valuable about the potential effects of the
same substance on ourselves. And while
animal studies of this sort may be an
easy target for the satirist, their
importance to human health decisions
and to the fate of everyday products
merits a more thoughtful discussion.
To begin with, there is almost no
aspect of the animal-to-people translation
not beset with uncertainty and embroiled
in intense scientific debate. Points of
contention include the extent to which
human versus animal cells are able to
combat potentially carcinogenic
molecules, how human organ systems
may differ from those of animals in the
way they handle or metabolize various
substances, and how actual human
exposure to these substances compares
with that of laboratory animals under test
conditions.
All of these factors come together in a
fundamental dilemma of animal testing
for potential cancer agents. This is that
many of the 20 or so known carcinogens,
such as asbestos and vinyl chloride, also
cause cancer in rats or mice, but the vast
majority of the more than 1,000
compounds that cause cancer in one or
more animal species do not do so in
people, to the best of our collective
scientific knowledge. Substances in this
category include saccharin, lead and
phenobarbital.
So, while there are apparently some
similarities between people and animals
in reacting to some cancer agents, this
relationship is hardly simple, direct or
consistent. If it were, the past few
DECEMBER 1984
17
-------
Animal Testing: continued
decades of our exposure to substances
that have caused cancer in rodents
should have steadily driven up the
occurrence of the disease among
ourselves. But they haven't. Too many
Americans now die of cancer (about one
in four), but the age-adjusted death rate
from cancer among the population as a
whole has remained nearly constant
since the 1930s. Further, the rate of
occurrence of most types of cancer has
remained stable or declined. One notable
exception is lung cancer which has been
increasing, due mostly, the experts feel,
to the effects of smoking tobacco.
Despite the tentative nature of its
usefulness, animal testing remains the
best experimental tool now available for
detecting substances with a carcinogenic
potential.
Obviously, we cannot deliberately
expose people to questionable materials
in order to judge the outcome. Further,
despite the arguments of the proponents
of such short-term, test-tube screens as
the Ames test, most experts agree that
not enough research yet exists to support
their use in place of animal studies.
In addition, our collective experience
with animal tests has taught us a number
of things to bear in mind as we both
design these studies and attempt to
interpret their results. For example, we
know that some substances will cause
cancer in some animal species but not in
others. Thus, the dye intermediate,
beta-naphthylamine, causes tumors in
dogs and hamsters but not in mice and
rats. In fact, we know that for some
species and some substances, sex
differences exist in the development of
tumors. To control for problems of
species differences, all reputable
researchers in government, industry and
academia now use more than one
species in testing a substance.
We also know that considerable
caution must be used in drawing
conclusions about the potential
carcinogenicity of a substance based
upon studies in mice. These animals are
particularly prone to spontaneous
development of tumors, especially liver
and lung tumors. As a result, some
researchers avoid using mice, and others
again compensate for this problem by
employing a second animal species. But
the knowledge of these and other caveats
still does not give us much confidence in
drawing conclusions about cancer for
people from animals. To improve this
process, we must do more basic research
in the area of pharmacokinetics. This
means we must learn more about the
similarities and differences between
people and specific experimental animals
regarding:
• how test substances behave in the
bodies of each;
• how these substances are transformed
or metabolized in the bodies of each, and
what breakdown products or metabolites
are formed;
• how long these materials remain in the
bodies of people versus animals;
• which organ systems they affect;
• and whether the metabolites, rather
than the parent compound, may be
carcinogenic.
The recognition of the importance of
these questions is growing among all of
those involved in the animal-testing
debate. Experts in and out of government
are starting to focus on the need for
answers. Provided the right research is
undertaken, we will be able in the near
future to make more meaningful use of
animal test results than we are now.
No discussion of animal testing would
be complete without touching upon that
issue which has sparked so much of the
human versus rodent debate: the use of
the "maximum tolerated dose" or MTD.
This is the highest dose that won't
reduce an animal's lifespan due to effects
other than tumors.
Critics of the MTD approach point out
the absurdity of its size in relation to
human exposure. For example, they
might cite two studies on
trichloroethylene (used to decaffeinate
coffee and for many other purposes)
which involved the human equivalent of
millions of cups of coffee a day.
The scientific critics also make a more
technical objection: that tumors
produced in animals under high-dose
conditions may reflect not the inherent
toxicity of the test substance but the
effects of bodily stress caused by organ
systems attempting to metabolize the
high doses in unusual ways.
Advocates of the MTD approach
contend that because so few animals
(relative to the human population) are
used in these studies, they must be
exposed to extremely high doses to
determine if the chemical has any
cancerous effect at all, particularly if it is
thought to be a weak carcinogen.
Fortunately, the debate is not at a
standstill. For product registration
purposes, regulatory agencies such as
EPA sometimes recommend the use of
three doses in chronic animal feeding
studies—the MTD, a low dose aimed at a
no-effect level, and a dose somewhere
between these two. Similarly, the
National Toxicology Program, the federal
government's principal animal-testing
arm for chronic effects, now has begun
to employ three doses in its studies.
These procedural changes are a
commendable attempt on the part of
federal agencies to obtain a more
complete and realistic picture of the
carcinogenic potency, if any, of test
substances. For example, the variety of
data yielded by several dosing levels can
help regulatory agencies construct better
"dose-response curves" against which
human exposure levels can be measured
and from which estimates of human risk
can be drawn.
Of course, this will only happen if
regulatory agencies use the data in this
way. But their record in this regard has
been spotty at best. Too often, we in
industry still see risk assessments
consisting mainly of mathematical
calculations based upon high-dose levels
in single animal species. These are of
18
EPA JOURNAL
-------
Weight check for a rodent, a routine pan of
tests for the effects of cancer agents on
these animals.
limited use. They are only one piece in
what ought to be a more fully developed
picture of potential human hazard. To get
this picture, the full complement of
information on a substance must be
considered, including its biochemistry and
pharmacokinetic aspects.
I would offer two other thoughts
regarding risk assessment. They concern
both how regulatory agencies, such as
EPA, use animal tests in this work, and
how they don't use other, equally (or
perhaps more) valid information.
Single positive animal studies have
been sufficient to put the agency's
rulemaking wheels in motion. But no
number of negative animal tests seems
adequate to keep these wheels from
spinning. A single negative study ought
not neutralize a positive, but several
negative findings contrasted with one
positive ought to cause regulators to
consider whether the appropriate next
step should be further research as
opposed to precipitate regulatory action.
A more troubling aspect of the
agency's risk assessment process is its
apparent lack of respect for well
conducted human epidemiological
studies. Now women and men seem to
count less than rodents in the
decision-making process. This despite the
fact that numerous scientific bodies have
stressed the importance of epidemiology
in determining human risk. As recently as
last August, an interdisciplinary panel
convened by Oxford University's Dr.
Phillipe Shubik reported that: "Human
data provide the only direct evidence that
a chemical produces cancer in
man....Because of their central role in the
identification of human risk,
epidemiological studies are indispensable
and require substantial expansion."
I'm not arguing for the use of human
evidence to the exclusion of animal data.
Instead, I'm urging that EPA take into
account as much quality information as
is available on a particular substance:
animal test results, human mortality and
morbidity, the route and extent of human
exposure, and studies that elucidate
species' similarities and differences.
The Roman poet Horace wrote that
"the mountains will be in labor, and the
birth will be an absurd little mouse." The
controversy over animal testing has
turned this couplet on its head: the
mouse has produced a mountain of
scientific debate. But as we scale up and
down this mountain, we need to keep in
sight the common destination—animal
testing systems that will allow us to do
what is right and reasonable in
protecting both our health and our
economic well-being. [ J
DECEMBER 1984
1')
-------
Summing Up
the New RCRA Law
by Jack Lewis
In November President Reagan signed
into law a bill reauthorizing and
amending the Resource Conservation
and Recovery Act (RCRA). RCRA is
administered by EPA's Office of Solid
Waste and Emergency Response
(OSWER).
RCRA is intended to prevent hazardous
waste disposal practices known to pose a
threat to human health and the
environment. Its provisions, geared to
the present and the future, complement
those of another EPA statute, also
administered by OSWER. The
Comprehensive Environmental Response,
Compensation, and Liability Act
(CERCLA)— better known as
"Superfund" — cleans up sites polluted by
unwise disposal practices used in the
past. Because of its preventive
orientation, the long-range importance of
RCRA is likely to be even greater than
that of CERCLA.
The new RCRA legislation will broaden
government restrictions on land disposal
of hazardous waste and greatly increase
the number of waste generators subject
to EPA regulation. Other provisions in the
new bill will significantly improve the
quality of landfills and surface
impoundments and place underground
storage tanks under EPA regulation.
Singled out below are the amendments
likely to have the greatest impact on the
future of hazardous waste disposal in the
United States.
Land Disposal Bans
and Restrictions
By specified dates, EPA must decide
whi.'ther it is safe to continue land
dispo:.. irge variety of hazardous
wastes. Should EPA fail to meet these
deadlines, so-called "hammer clauses"
go into effect prohibiting such disposal.
Deadline
Hazardous Waste
(Lewis is
Journal.)
/ ditoi ot ihu I PA
November Solvents and dioxin
1986
July "California" wastes
1987 (Wastes currently banned
by the State of California)
August 1/3 of EPA's listed
1988 hazardous wastes
November Underground injection of
1988 solvents, dioxin, and
California wastes
June 2/3 of EPA's listed
1989 hazardous wastes
May All listed and characteristic
1990 wastes
If EPA fails to make a determination
during the allotted time for California
wastes, dioxins, solvents, characteristic
wastes, and the "last third" of listed
wastes, land disposal of such waste
will be prohibited.
If EPA fails to make a determination by
August 1988 and June 1989 for the "first
and second thirds" of the listed wastes,
disposal in a landfill or surface
impoundment may continue only if (1)
the generator certifies that there is no
alternative capacity available, and (2)
disposal takes place in compliance with
the minimum technology requirements.
However, if EPA still has not made a
determination by May 1990, land
disposal of all such waste will be
prohibited.
In addition to ruling on various types
of land disposal, EPA must promulgate
regulations specifying methods of
treatment capable of substantially
reducing the toxicity of the waste or its
likelihood of migration from a disposal
unit or injection zone. Wastes which are
so treated will be exempt from the ban
on land disposal.
Petitioners defending any disputed
method of land disposal must
demonstrate to EPA that there will be no
migration from a disposal unit or injection
zone for as long as the waste remains
hazardous.
Regulation of
Underground Storage Tanks
The new RCRA legislation brings
underground storage tanks containing
hazardous substances under EPA
regulation for the first time. Corroded or
leaking underground storage tanks have
been linked with serious instances of
ground-water pollution. EPA must set
final standards for three types of
underground storage tanks according to
the following schedule:
Deadline
Type of Tank
February
1987
August
1987
August
1988
Petroleum tanks
New tanks containing
CERCLA hazardous
chemical products
Existing tanks containing
CERCLA hazardous
chemical products
By May 1985, installation of certain
types of underground storage tanks must
cease.
EPA's final standards must include
certain requirements for existing and
new tanks. Regulations for existing tanks
must cover leak detection and tank
testing, record-keeping and reporting,
corrective action, financial responsibility,
and closure. Regulations for new tanks
must include design, construction,
installation, release detection, and
compatibility standards.
The states have the option to
administer their own equally stringent
version of EPA's underground storage
tank program. They may apply for such
permission 30 months after enactment.
By November 1985, EPA must
complete a study of petroleum tanks. The
agency has until November 1987 to
conduct studies of (1) underground tanks
containing other "regulated substances,"
and (2) certain "exempted" tanks.
EPA JOURNAL
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Work crew installs double liners at new
landfill in Cape May County, NJ. Under
new amendments by Congress, EPA will
issue regulations or guidance on the use of
double liners.
Improvements
in New and Existing
Land Disposal Facilities
The new version of RCRA calls for
upgrading standards applicable to new
landfills, surface impoundments, and
waste piles, it also proposes
improvements in existing surface
impoundments through a process known
as "retrofitting."
EPA has until November 1986 to issue
regulations or guidance documents on
the use of double liners. In the past,
single liners have been sufficient to meet
EPA requirements. Liners are continuous
layers of synthetic or earthen material
placed beneath hazardous waste to
prevent its escape into areas surrounding
a landfill or surface impoundment. Prior
to the November 1986 deadline, EPA's
new double liner requirement may be
satisfied through the installation of a
synthetic or clay liner system that meets
certain specifications.
Owners or operators of interim status
land disposal units that first receive waste
after April 1985 must comply with RCRA
requirements for double liners and
leachate collection when expanding or
replacing landfills, impoundments, and
piles. In addition, most interim status
surface impoundments must retrofit with
double liners and leachate collection
within four years of enactment
of the RCRA amendments. (Interim status
facilities are those that comply with a
certain set of EPA requirements and are
allowed to operate, while their application
is being processed.
Inclusion of
Small-Quantity Generators
Prior to enactment of the new RCRA
legislation, EPA regulated persons who
generated at least 1,000 kilograms/month
of hazardous waste. Now EPA must
promulgate standards, no later than
March 31, 1986, for persons who
generate between 100 and 1,000
kg./month of hazardous waste. This
provision will expand the population of
RCRA-regulated waste generators from
14,000 to approximately 100,000.
By July 1985, waste generated in
quantities between 100 and 1,000
kg./month must be accompanied by an
EPA manifest if shipped off-site. By
September 1, 1985, all manifests must
contain a certification by the generator
that the quantity and toxicity of the waste
shipped off-site has been reduced to the
maximum degree economically
practicable.
Subtitle D
Facilities
Subtitle D of RCRA deals with solid
waste management facilities (e.g.,
municipal landfills). EPA's previous
criteria for these facilities were
enforceable by the states, but not EPA.
The new RCRA also gives EPA
enforcement authority. EPA is to step in
if the states fail to meet deadlines for
developing programs to ensure that their
solid waste management facilities comply
with RCRA's existing and added criteria.
By March 31, 1985, EPA must revise its
criteria for solid waste management
facilities that may receive hazardous
household or small-quantity generator
waste. At a minimum, EPA must require
ground-water monitoring, establish
location criteria, and provide for
corrective action, where appropriate.
Listing
of Hazardous Wastes
The new RCRA legislation stipulates that
EPA must make listing determinations on
21 specific substances. After analyzing
their proportions, the agency has to
decide which of these substances should
be regulated as hazardous wastes.
Deadlines have been set for agency
action on each substance.
By November 1986, EPA must also
make various additions to its list of
hazardous characteristics. First, RCRA
requires the agency to determine
measurements of organic toxicity.
Second, the law requires EPA to identify
a medium for toxicity testing that
accurately predicts the leaching potential
of hazardous wastes.
The new RCRA also changes the way
EPA must handle petitions to "delist"
specific wastes. Companies submit
delisting petitions to EPA if they believe a
specific waste differs significantly from
its apparent counterpart on the EPA list,
so much so that it can be considered not
hazardous.
Under the old law, EPA could consider
only factors weighed in its original listing
decision when processing delisting
petitions. The new RCRA states that EPA
must consider additional factors when
evaluating delisting petitions. The law
also specifies that "temporary" delistings
granted by the agency are to lapse
automatically after 24 months if EPA
does not finalize them.
DECEMBER 1984
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Underground storage tanks will be regulated
by EPA under amendments to RCRA
(Resource Conservation and Recovery Act}.
Permitting of
Hazardous Waste
Facilities
The new RCRA requires that permits for
hazardous waste facilities be renewed
every ten years. Land disposal permits,
however, are subject to more frequent
review: every five years.
Applications for permit renewal are
subject to all the regulations that pertain
to the issuance of new permits. RCRA
also specifies that these applications
must reflect improvements in control and
measurement technology that have
occurred since the previous permit was
issued.
The new RCRA legislation sets the
following timetable for Part B permit
applications. Part B is a more detailed,
narrative application that must be filed
pursuant to a briefer Part A form.
Facilities run the risk of losing their
interim status if they miss these Part B
application deadlines:
Facility
Land
disposal
Interim Status
Terminates
Unless Part B
Submitted
November November
1985 1985
Incinerators November November
1989 1986
Other November November
facilities 1992 1988
Part B permit applications for landfills
and surface impoundments must be
accompanied by an assessment of the
potential for public exposure to any
hazardous substances that might be
released from these units.
EPA, for its part, has to meet the
following deadlines in processing Part B
applications:
Deadline
November
1988
November
1989
November
1992
Type of Part B Application
Land disposal
Incinerators
Other facilities
for appropriate relief. EPA will exercise
these powers as necessary on a case-by-
case basis to protect human health and
the environment.
Citizen
Under the new RCRA legislation, EPA
is authorized to issue temporary permits
for experimental facilities without first
issuing permitting standards. Such
permits are limited to one year, but are
renewable each year for up to four years.
They are designed to foster innovation in
the hazardous waste industry.
Corrective Action
Requirements
Under the new RCRA, EPA will be
required to promulgate regulations
requiring handlers of hazardous waste to
furnish evidence of financial
responsibility for corrective action. The
new legislation extends responsibility for
corrective action beyond the facility
boundary and mandates that EPA should
issue regulations to this effect as soon as
possible. All permitted facilities and
interim status landfills, impoundments,
and piles that received waste after July
26, 1982, will be subject to these new
regulations. EPA also is authorized to
require corrective action for releases of
hazardous waste or constituents from
any solid waste management unit,
regardless of when the waste was placed
in the unit, or whether the unit is closed.
Owners or operators of such facilities
must also ensure that they have adequate
funds to cover the cost of cleaning up
these releases.
Under the new RCRA, EPA is also
authorized to issue an administrative
order requiring corrective action for
releases of hazardous waste from interim
status facilities. In addition, the agency is
empowered to commence a civil action
Suits
Under Section 7003 of the new RCRA
legislation, private citizens are authorized
to bring legal action in cases where past
or present hazardous waste management
practices pose an imminent danger. They
can bring this action against companies,
governmental entities, or individual
citizens engaged in imminent hazards.
Section 7003 applies to past generators
as well as to situations or sites where
past acts or failures to act may have
contributed to a present endangerment
to human health and the environment.
Citizen rights to sue are limited,
however, (1) if EPA or the state
government is diligently bringing and
prosecuting a related action under
Section 7003 of RCRA or Section 106 of
CERCLA, or (2) if EPA or the state has
settled a related action by entering into a
consent decree.
Neither citizens nor EPA can take
action against common carriers for
imminent hazards arising after shipments
are delivered to the consignee.
EPA has several responsibilities
pertaining to citizen rights under RCRA.
The agency has to notify local officials
and post a sign at any site thought to
pose an imminent and substantial threat
to human health and the environment.
EPA also has to provide for public notice
and comment before it enters into any
settlement or covenant not to sue under
Section 7003. Finally, RCRA stipulates
that EPA must establish an Office of
Ombudsman to provide information to
the public, and to receive and assist in
resolving citizen complaints. D
EPA JOURNAL
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The People at EPA
by Margherita Pryor
Bureaucrat is not a nice word. It's
usually preceded by words like
"paper-pushing," "faceless," or "petty."
Even the dictionary refers to a bureaucrat
as "an official who works by fixed
routine without exercising intelligent
judgment."
And if movie images are any gauge of
popular sentiment, bureaucrats occupy a
niche in the public's heart only slightly
above that of used car salesmen.
Whether foreclosing on family farms,
nitpicking businesses into bankruptcy, or
harassing innocent citizens, they exist
only to inspire instant loathing. When the
obnoxious EPA official in Ghostbusters
was insulted by the stars and then
drowned in marshmallow fluff, audiences
cheered.
Once government agencies were the
good guys. Their employees were
represented by the likes of Robert
Bedford. Now they are portrayed as a
collection of nerds, wimps, and
pettifoggers. Beyond the lure of a steady
paycheck, what could possibly induce
people to work for an organization
supposedly characterized by red tape,
low public esteem, and frustration?
' ,
Public Atf,:.-
At EPA, the motives are as varied as
the 13,000 people who work here.
They're a diverse lot professionally. As
might be expected, many pursue
occupations such as engineering,
chemistry, office management, law,
economics, accounting, computer
science, and public administration. But
others are involved in less expected
areas such as urban planning,
horticulture, psychology, geography,
genetics, agronomy, sociology, and
meteorology.
Many employees applied to work for
EPA because they wanted to help solve
environmental problems; some were
"inherited" from other agencies and
offices when EPA was created in 1970;
still others just needed a job. Once they
reached the agency, however, most
employees came to share a deep belief in
EPA's mission and a desire to contribute
to its success.
David Hawkins, a former Assistant
Administrator for Air, Noise, and
Radiation, came to EPA from the Natural
Resources Defense Council. Having
worked on both sides of the
environmental fence, he concludes that
almost everyone at EPA is genuinely
motivated to do the best job possible. "If
you're interested in the implementation
of federal environmental laws", says
Hawkins, "EPA is the only place to work.
its mission is strongly supported by the
public, so you teel that you're working in
the public interest. But even though the
public supports what you're doing, that's
not the feedback you get. The typical
feedback comes from the regulated
industry or some member of Congress
complaining that you are doing your job.
Out of 50 complaints, I'd say that 49 are
that you're doing your job too diligently."
Nevertheless, Hawkins recommends
working at EPA. "The agency has many
different types of people, and I enjoyed
that variety. It was a very positive
experience, very stimulating. It was a
challenge."
"Challenge" and "meaningful" are the
two words most frequently used to
describe work at the agency. "My
expectations were very low when I
started here", says one employee. "I
didn't think it would be possible to see
real changes. But in fact, I've experienced
a lot of satisfaction. My background is in
health and nutrition, and my M.S. is in
public policy. I'm being challenged to use
all my experience to help bridge that gap
between science and government.
"Sometimes I feel like I'm using a
chisel to hack at a mountain, but I really
enjoy my work and the people I work
with. EPA is just not like any place else in
government."
Many employees have also found EPA
an exceptional place for reasons aside
from its environmental mission. "I
DECEMBER 1984
-------
EPA employees work in man
• out shan
comi: .
Here, Administrate! Wn
shakes hands and chats with agency
employees at an infoi .t May
marking the first year a:: ' '•;:«/'
swearing-in.
started here as a secretary," says one
woman, now a program analyst. "The
agency has challenged me. EPA is one of
the few government agencies that
encourage and allow people to cross
from clerical to professional positions. Its
upward mobility program really is a good
incentive for people and it's taken
seriously."
This perception by EPA employees that
they and their agency are a breed apart
was confirmed in a recent study
conducted by the National Academy of
Public Administration (NAPA). It included
a questionnaire survey of more than ten
percent of EPA employees, and was
based on extensive interviews with top
EPA leadership, with employees in all
regional offices and major laboratories,
and with outside experts. NAPA found
that:
• Many employees joined government
solely or primarily to work for EPA;
• Many employees view their jobs as
"noble challenges" rather than just
economic necessities. (Ninety-one
percent of those polled in the survey said
that the chance to accomplish something
worthwhile was very important to them);
and
• Many employees in offices not directly
related to environmental concerns—
administration, personnel,
finance—nevertheless view their jobs in
terms of helping EPA do its work.
EPA has more than 13,000*
employees in over 200 job
categories, but almost 40 percent of
them fall into four groups:
sanitary engineer 1,673
secretary 1,129
physical scientist 1,082
environmental protection 1,000
specialist
Here is another way of looking at
the EPA work force.
Men 7,599
Women 5,707
Blacks 2,263
Hispanics 367
Asians 346
American Indians 35
• All figures as oi 9/30/84
As one employee commented, "I
studied business and management in
college. I carne when the agency was
formed because I felt that the
environmental field was the only place to
work, that it was something I could be
enthusiastic about on a day-to-day basis.
I guess I really was affected by Earth
Day. In spite of the last few years, I still
have enthusiasm, still enjoy working for
the agency. I'll probably end my federal
career right here at EPA."
NAPA concluded that the agency's
success is in great part due to the
commitment and dedication of its
employees, almost 2,000 of whom have
been with EPA since it began. "They
clearly want to be where they are, and
doing what they are doing. . . . That the
agency works as well as it does is a
tribute to its people."
EPA Administrator William Ruckelshaus
said the same thing before a Senate
committee in May 1983: "EPA's greatest
resource today is the same as when we
started: its people." And as another
employee says, "Yes, this is socially
responsible work that contributes to the
world's betterment, but what it really
comes down to is this: I'm doing this for
my children. It's their future I'm taking
care of." G
24
EPA JOURNAL
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Four-Footed Detectives
by Susan Tejada
At 10:30 a.m. on November 9, 1983,
about 40 people gathered at the site
of an old World War II Army depot in
Edison, N.J., to find out if a newly trained
hazardous waste worker could make the
grade.
On this pleasant, breezy day, the
worker's task was specific: go to a
half-acre site normally used as an
obstacle course in training emergency
response personnel, and find samples of
toluene that were hidden either in the
obstacles or in the ground.
Before the test began, an examiner
with an organic vapor analyzer moved
toward one of the toluene targets. His
instrument should have been able to
detect less than one part per million of
toluene. But the examiner couldn't get
any reading at all until he placed the
probe of the instrument right next to the
ground where the sample was buried.
The crowd was skeptical. The scientific
instrument hadn't performed so well.
How could a new worker do any better?
The test began. Approaching from 50
feet away, the worker almost
immediately uncovered the first toluene
sample hidden in the jack of a flatbed
truck. A few minutes later the worker
discovered the same toluene sample that
the instrument had failed to detect from
a distance and, a few minutes after that,
another sample partially submerged in
rainwater in a tire.
The worker had passed a difficult test,
but didn't seem anxious to celebrate with
a beer down at the local hangout.
Instead, this worker was more interested
in playing with a Frisbee. This worker
was a dog.
Common sense
"It's common sense that a dog can be
sensitized to identify specific pollutants,"
says Hugh Masters. "They've been doing
it for years with other substances like
narcotics."
(Tejada is Associate Editor of the
EPA Journal.;
Masters is the project officer for the
recently completed EPA experiment
officially known as "Toxic Area
Delineation by Canine Olfaction." Over
an eight month period running from
August 1983 to April 1984, the project
tried to find out if trained dogs could be
safely put to good use in environmental
programs. The project was carried out
under subcontract to EPA's Oil and
Hazardous Materials Spills Branch in
Edison, part of the agency's Municipal
Environmental Research Laboratory.
Masters' reference to a long-standing
reliance on the scent detection
capabilities of dogs is accurate. Use of
dogs to track people or sniff out bombs
and narcotics is well known and well
documented. Some dogs have also been
trained to detect termites and gypsy
moth nests.
Glen Johnson, operator of the
Guardian Training Academy for tracking
dogs in Windsor, Ontario, has trained
dogs to detect leaks of insulating fluids
from underground electric power
transmission cables. In his book,
Tracking Dog: Theory and Methods,
Johnson describes another
environmental use for dogs.
"In 1974," Johnson writes, "I was
commissioned to train dogs to search for
and locate leaks in a brand new natural
gas pipeline...The consulting engineering
firm that designed the line...had
attempted, unsuccessfully, to locate these
leaks with every instrument known to
modern technology..."
Johnson trained three dogs to detect
the odor of butyl mercaptan, a substance
in the leaks. "By the time we had
completed [going over the 94-mile]
pipeline three times," Johnson reports,
"the dogs had successfully detected over
150 leaks, 4 leaky valves (one of them
over 12 feet above the ground), through
snowstorms, zero degree weather, [and]
quicksand...and over rivers, highways,
and plowed fields. The smallest leak was
microscopic [and] was buried 18 feet
deep..."
As a professional dog trainer with 15
years of experience, Herb Skovronek was
familiar with the tracking dog work of
Glen Johnson and others. As a
professional scientist with a Ph.D. in
chemistry and several years of
experience at EPA's Edison lab,
Skovronek was also familiar with the
problems encountered at hazardous
waste sites.
Seven years ago, Skovronek proposed
to EPA the idea of using canine olfaction
at such sites. His suggestion evoked no
interest at all, probably, he explains,
because "we weren't as keyed in to
hazardous waste issues then as we are
now." Two years ago Skovronek, by then
a private consultant, tried again, and this
time the Edison lab decided to give it a
shot. Masters was named project officer
not only because of his scientific
qualifications, but also because he, like
Skovronek, moonlights as a dog trainer.
For the project staff, says Masters, in
addition to Skovronek, "We went to the
best experts we could find": Glen
Johnson and dog breeder and trainer
Don Arner, co-founder of the North
American Canine Olfaction Society.
With the human staff complete, the
next task was to find the right animals. In
order to produce search and retrieval
results fast, the staff decided to use dogs
and handlers who had already carried
out scent-related work successfully. The
two dogs selected were Justa, handled
by owner Joyce Arner, and Niner,
handled by owner Melvin Manor.
Search and retrieval
The goal of the first stage of the project
was to train Justa and Niner to recognize
toluene and 2,4,5- and
2,4,6-trichlorophenol at levels that could
not be detected as quickly or efficiently
with conventional field instrumentation.
The animals were to seek out and
retrieve articles contaminated with these
chemicals, or dig at the site of a
simulated ground contamination.
The particular chemicals were chosen
partly because of their potential presence
at actual sites. Toluene is a component of
DECEMBER 1984
25
-------
jt SUCC(:~- •
German Shepherd, leads ham.: •
Amor to a hazardous waste samp i
in a lire
gasoline. Trichlorophenols are often
found along with dioxin, and in fact are
often the precursor of dioxin.
The chemicals were applied by
hypodermic syringe to cotton balls
placed inside containers (wooden dowels
and plastic film canisters) perforated with
holes. While vapors diffused out of the
containers, the animals were protected
from direct contact with the compounds.
At the low levels used, the odors soon
became undetectable to the handlers.
Blanks—containers without
chemicals were also hidden to further
test the dogs.
As training proceeded, concentrations
of toluene were reduced, samples were
allowed to age up to 24 hours, and
distances were increased. Both dogs
rapidly reached the point where,
according to the project report, they
could "smoothly and consistently find 0.1
gram of toluene that was as much as 24
hours old and from distances of as much
as 50 feet. To chemists familiar with the
volatility of toluene, this must be quite
surprising, since it is unlikely that any
toluene remains at the source after 24
hours, much less in the ambient air at
such distances from a source." Training
with the trichlorophenol also progressed
quickly.
By November 1983, the dogs were
ready for their field test. Justa worked
outdoors; Niner, indoors. As described
above, Justa found three contaminated
samples. Returning later in the day with
Niner, she found all the remaining
samples except one.
Indoors, Niner worked in a large
warehouse where samples had been
hidden in tires, wooden pallets, drums,
and chunks of concrete. He found four
samples and one blank during the test.
Perimeter delineation
In the second stage of the project, the
staff wanted to train a dog to respond at
the first whiff of toxic and hazardous
chemicals without advancing to the
source. Since this goes against both the
animal's instincts and normal training
protocols, the staff decided to use a dog
with no previous training. Yeller was
acquired from the local pound, and
trained and handled by Don Arner.
The goal was to teach Yeller to sit the
moment he detected the scent of his
target chemical. The intent was to
demonstrate that a dog could delineate
the perimeter of a contaminated area
without entering the hot zone. The
chemical—1,2,3-trichloropropane—was
chosen because it was a key pollutant at
the planned test location, Tyson's Dump,
an abandoned waste site near King of
Prussia, Pa., that is on the Superfund
priority list.
There was a bad storm on March 28,
1984, the day of the field test, with heavy
winds and torrential rain. Yeller
responded as he had been trained to do
when he was brought to a nearby seep
from the downwind direction, but his
other responses were inconclusive.
Viable
Based on training and field test results,
the project team determined that "the
concept of using dogs to assist
environmental workers in locating
pollutants and in defining the perimeter
of toxic and hazardous chemical
presences in the environment is
viable...Once a dog has been trained to a
search protocol with one or more specific
chemicals, it is possible and practical for
him to adapt quickly to other chemical
stimuli, thus allowing one trained dog to
be used for a multitude of specific
problems as they arise."
Last April, this experiment to find out
just how much a dog's nose knows
ended. According to Hugh Masters, the
New Jersey Institute of Technology, in
collaboration with Herb Skovronek, has
submitted a proposal to continue the
experiment with more dogs and more
sophisticated equipment. If this
cooperative research project is awarded,
predicts Masters, scientifically defensible
data supporting the use of dogs will be
the result.
For the present, Masters and
Skovronek view two uses for trained
dogs as most promising. The first is
detecting gasoline leaks from
underground tanks. It is estimated that
underground tanks at one-fourth of the
nation's 2.3 million operating service
stations are leaking, and Congress
recently authorized EPA to regulate such
tanks. The challenge, Skovronek explains,
is to train a dog to differentiate between
the odor of fresh gasoline, the odor of
gasoline coming up from underground,
and the odor of gasoline that has aged in
ground water. "Can the dog differentiate
between these scents?" Skovronek asks.
"We think it can. We have to prove it."
The second use they foresee is in
double-checking decontamination of
heavy equipment after a site cleanup.
Normally the equipment is hosed down
after use, and decontamination is verified
by random swab tests. Dogs could speed
up the process by locating contamination
in inaccessible parts of equipment that
are not easily swabbed.
These particular uses are so promising
because they are relatively safe. Gasoline
vapors are not highly toxic, and
decontamination checking puts a dog in
contact only with small amounts of
chemicals.
Other potential applications are at a
standstill right now because the safety of
the animal cannot be guaranteed. For
example, it is sometimes necessary to
take a large number of samples at a
suspect site to define the extent of
contamination. At one dioxin site in
Missouri, about 8,000 samples out of
v
EPA JOURNAL
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«* - *
m
.
V.
r.
:
more than 10,000 collected turned out to
be negative. Using dogs to pretest or
screen samples could save considerable
lab costs, but, says Skovronek, "I have
not yet found a way to design a dioxin
experiment that would be safe to the
handler and the dog, and that stymies
me." He thinks that, were it not for the
same safety problem, dogs could also be
used to delineate the area of a PCB spill
or to detect PCB leaks. But the first
questions you have to askr says
Skovronek, are "What's there? Is it
dangerous? If it is, I'm not going to bring
my dog there."
It is unlikely that dogs will ever be
used to scout out an abandoned site
where there is no information on the
chemicals present. For one thing,
explains Royal Nadeau, a member of
EPA's Environmental Response Team,
"You need prior knowledge of the site to
know if the dogs have been trained to
detect what's out there." For another, it's
too dangerous. "You would never let the
dogs go to ground zero," says Nadeau.
"You would never go into a situation
where the handler has protective gear
and the dog doesn't."
Of the three dogs who participated in
the project, none exhibited any ill effects
due to that participation. In fact, it was
the consensus of their handlers that the
animals would have been exposed to
more hazardous chemicals in a flea dip
than through working in this experiment.
The project report concludes "the use
of canine olfaction introduces an
innovative and potentially cost-effective
technique for quickly locating pollutants
in the environment." After working with
the dogs, handler Joyce Arner agrees.
Once a dog has been trained to locate
the pollutants, she says, "it can do it a lot
faster and more accurately than human
beings, and can find more minute doses
at greater distances than instruments."
As a matter of fact, warns Skovronek, the
dog's ability to locate minute doses can
actually be a problem. "Do we really
need to detect parts per quadrillion?" he
asks. And though the dogs may detect
chemicals before instruments do, use of
instruments is not likely to disappear. "If
I used a dog," says Nadeau, "I would still
want instrumentation for backup in case
we went to court for cost recovery."
Masters and Skovronek have few
doubts about the ability of trained dogs
to assist at hazardous waste sites.
Nevertheless, they caution that the
animals' contributions should be kept in
perspective. "The dogs won't solve all
our problems," says Skovronek. "But
they will solve some of them." G
(Copies of the Toxic Area Delineation by
Canine Olfaction project summary sheet are
available from Hugh Masters, Environmental
Protection Agency, OHMSB/MERL, Edison,
NJ 08837; phone 2011321-6740.)
DECEMBER 1984
27
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Making Pollution Prevention Pay
by Dr. Robert P. Bringer
Pollution Prevention Pays. That
phrase was put into capital letters
in 1975 when the 3M Company made it
an integral part of its worldwide
manufacturing operations and
environmental policy.
And 3P—short for Pollution Prevention
Pays—has, indeed, paid off.
Now 10 years old, the 3P program in
the United States can point to these
totals for pollution prevented annually:
Air pollutants—85,000 tons.
Water pollutants—10,000 tons.
Wastewater—590 million gallons.
Sludge/solid waste—142,000 tons.
Most of 3M's manufacturing is done in
the United States, at plants in 37 states.
But the company also has manufacturing
operations in 30 foreign countries on six
continents and there, too, 3P is helping
the environment. Overseas, the totals of
pollution prevented annually are 8,000
tons of air pollutants, 400 tons of water
pollutants, 400 million gallons of
wastewater and 3,000 tons of sludge and
solid waste.
The environment hasn't been the only
beneficiary of 3P.
Worldwide, the program has achieved
savings of more than $200 million in the
past decade, 80 percent of it in the
United States.
The savings are the result of pollution
control equipment purchases that were
eliminated or delayed, raw materials
saved and operating costs reduced,
energy saved, and sales retained on
products which might otherwise have
been taken off the market as
environmentally unacceptable.
"Pollution Prevention Pays" became a
part of 3M manufacturing operations at a
time when many new and complicated
environmental laws and regulations were
being generated by the states as well as
the federal government. The new
requirements were generally viewed by
industry as a no-alternative mandate. The
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conventional response was to install
costly add-on pollution control
equipment in order to filter out
contaminants at the end of the
manufacturing process.
The company looked beyond the
negatives of cost and paperwork in this
new regulatory climate and found a
positive side, an alternative way to show
concern for the environment: Don't
create pollution in the first place.
Eliminate or minimize pollutants at the
source, in the manufacturing process.
As a result, 3P was born. Today, ten
years later, it keeps growing, reducing
pollution, conserving resources, saving
money and spawning innovative
technology.
The pollution-prevention approach is
not unique and does not, of course,
displace pollution control as an important
strategy to ensure continued
environmental compliance by the firm's
numerous and widespread
manufacturing activities. But as an
organized company- wide program, 3P has
been an increasingly profitable and
valuable ally in the firm's environmental
management strategy. The program
seeks pollution prevention answers in
four areas:
(1) Can the product be formulated with
substitute, non-polluting raw materials?
(2) Can the process be changed?
(3) Can the equipment be redesigned?
(4) Can materials be recycled and
reused?
Technical employees in manufacturing,
engineering, and product research
laboratories have provided the answers.
Since 1975 more than 1,200 proposals
have won the coveted designation,
"Approved 3P Project."
A proposed 3P project has to eliminate
or minimize a pollutant, save resources
and money, and also show a technical
achievement. Projects are judged by a
committee of technical peers. It's a tough
jury. More than half the proposals
submitted fail to win approval.
The savings don't have to be dramatic
or the technology complicated to win
recognition. Here are some examples:
• Removing a chemical discharge solved
a water pollution problem and
simultaneously created a new
revenue-producing product.
• A hazardous waste was minimized,
materials were saved and clean-up time
reduced simply by using a shallower pan
for a coating solution.
• By substituting an aqueous for a
solvent-based coating for medicine
tablets, the need for costly pollution
control equipment was eliminated.
• Energy-rich solvent-filled air was
rerouted from the stack and incinerated
in a converted boiler and now provides a
fifth of the manufacturing plant's normal
steam needs; air pollution was prevented
and the energy bill reduced.
• A process modification to reclaim and
reuse a solvent cost $4,000 to install and
saved $12,000 the first year.
"Pollution Prevention Pays" has
provided benefits beyond the more
obvious ones of protecting the
•
EPA JOURNAL
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environment, wiser use of resources,
money saved and technology advanced.
A significant, though not readily
apparent plus is the fact that
pollutant-free products don't create
cleanup or disposal problems for the
consumer. When pollution is exported, it
means that ultimately more resources,
time and money have to be spent to deal
with it.
Facilitating compliance with
environmental regulations is a second
benefit. With the 3P touch, air and water
quality standards are not only met but
often are exceeded.
The 3P success story has contributed
to an increasing awareness in the
industrial community of the possibilities
and rewards of pollution prevention. The
firm has shared its experiences, including
how to organize a comprehensive
company-wide 3P program, with
hundreds of inquiring private and public
organizations in the United States and
abroad.
A fourth benefit is that the 3P track
record has given us improved credibility
with legislative and regulatory bodies.
This facilitates technical conversations
with the agencies, enabling us to share
experience and expertise in a manner
that contributes to meaningful and
reasonable environmental protection
measures.
Finally, because 3P applies to both
conventional pollutants such as
suspended solids in water and
nonconventional pollution such as toxic
substances, it has helped position the
company to deal with environmental
issues no less complicated or demanding
than those industry and government
have faced in the past. Major ones for
the foreseeable future include hazardous
waste and toxics control.
The challenges are complicated, but
I'm encouraged to see a moderation in
the combative climate that, in the past,
too often accompanied the resolution of
environmental problems. There seems to
be a change in attitude from
confrontation to cooperation between
government and industry, and I think
positive industry programs such as 3P
have helped bring about the change.
Government is now more interested in
the technical knowledge of industrial
professionals concerning the
development of environmental
regulations. Where such information was
once regarded with suspicion and as
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self-serving, it is now accepted as
valuable input.
When cooperation and understanding
replace conflict, technical solutions to
environmental problems aren't all that
difficult.
Answers to pollution questions don't
always have to be hammered out in the
public arena, of course. Many are to be
found in industry's own house, as 3M's
Pollution Prevention Pays program has
demonstrated.
The 3P approach, while not a solution
to all of 3M's cleanup needs, will
continue to solve pollution puzzles to
help the environment and many firms
throughout business and industry. Its
ultimate goal is to eliminate industrial
pollution entirely. That's Utopian,
certainly, but still a goal worth striving
for. D
DECEMBER 1984
-------
UPDATE
A review of recent major EPA
activities and developments in the
pollution control areas.
AIR
Rules for Pristine Areas
EPA has proposed federal
regulations under the Clean Air
Act for new pollution source
review and monitoring
requirements for 34 states which
failed to adopt such measures in
order to protect visibility in and
around pristine areas.
In December 1980, EPA
published visibility requirements
for states near certain national
parks, wilderness areas, and
international parks. Under the
requirements, those states were
to issue regulations for the
review of new industrial sources
of air pollution and establish
monitoring requirements that
would protect the clarity of the
air in federal areas where the
agency determined that visibility
is desirable.
States adjoining or
surrounding these areas, which
are protected under the
Prevention of Significant
Deterioration (PSD) requirements
of the Act, were required to
amend their state
implementation plans (SIPs) to
provide for visibility protection.
Of the 36 states required to
develop and adopt plans, only
Alaska's and Louisiana's plans
have been approved.
In 1982, the Environmental
Defense Fund filed suit to
compel EPA to develop plans for
the deficient states. EPA and EOF
reached a negotiated settlement
on this issue on April 20, 1984,
and EPA's current proposal is a
result of that settlement.
EPA is proposing disapproval
of the visibility new source
review and visibility monitoring
provisions of the 34 states' Clean
Air Act implementation plans. In
addition, the agency proposes
that federal regulations be
carried out by EPA in lieu of the
approved state implementation
plans for those provisions.
EPA is proposing a national,
rather than state-by-state,
visibility monitoring program in
cooperation with the Department
of the Interior and the
Department of Agriculture in
order to take advantage of
existing federal monitors and
ongoing work.
Strip Mines Listing
EPA has proposed making many
future surface coal mines, or
strip mines, subject to
construction permitting
requirements for major sources
of air pollution under the Clean
Air Act.
If finalized, the proposal would
require that "fugitive" emissions
from these sources be taken into
account in determining if a
source is a major emitting facility
required to meet preconstruction
permit requirements. Fugitive
emissions are those not vented
through a stack. In this case,
they often involve dust and
particulate matter emitted into
the air from mining procedures.
EPA is also issuing a final rule
retaining and clarifying its 1980
rules specifying that fugitive
emissions from 30 listed source
categories be included in
determining emissions rates.
Proposed Air Standards
EPA has proposed nitrogen
oxide standards for light and
heavy-duty trucks and particulate
standards for heavy-duty diesel
trucks. This represents the first
time that particulate emissions
from heavy-duty diesels would
be controlled.
The new standards would
prevent significant increases in
nitrogen oxide (NOx) and
particulates which could cause
difficulty for some areas of the
country in meeting the National
Ambient Air Quality Standards in
the future. With stringent
controls on passenger cars,
heavy trucks now contribute the
bulk of NOx and particulate
emissions from motor vehicles.
Starting with the 1987 models,
all light trucks weighing up to
6,000 pounds gross weight
would meet a 1.2 grams per mile
(gprn) nitrogen oxide (NOx)
standard. Light trucks weighing
over that amount (up to 8,500
pounds) would meet a 1.7 gpm
NOx standard. The existing NOx
standard for both classes of
light-duty trucks is 2.3 gpm.
The agency said the 1.7 gpm
standard for these trucks is
based on the technological
problems of also meeting the
applicable paniculate standard
(0.26 gpm) for the 1987 model
year. The interaction between
NOx and particulates makes it
difficult to control both of them
at low levels in heavier vehicles.
Proposed Radionuclides
Standards Withdrawn
EPA has announced the
withdrawal of its 1983 proposed
standards for radionuclide
emissions under the Clean Air
Act. The standards would have
applied to phosphorus plants,
Department of Energy (DOE)
facilities, non-DOE federal
facilities, Nuclear Regulatory
Commission (NRC) licensed
facilities, and underground
uranium mines.
Radionuclides are radioactive
materials which break molecules
into electrically charged
fragments called "ions" and
thereby produce chemical
rearrangements that may lead to
permanent cellular damage.
They occur naturally in rocks or
minerals and are produced in
nuclear reactors, nuclear
weapons production procedures,
and nuclear accelerators.
The withdrawal of the
proposed standards for
phosphorus plants, DOE
facilities, NRC-licensed facilities,
and non-DOE federal facilities is
based on an EPA determination
that current practices provide an
ample margin of safety to
protect public health from the
hazards associated with
exposure to airborne
radionuclides. For underground
uranium mines, the agency has
concluded that the risks are
significant, but that rules based
on the original proposal could
not legally have been issued
under the Clean Air Act.
The agency is also issuing an
Advance Notice of Proposed
Rulemaking (ANPRM) to
consider developing standards
for radionuclides from licensed
30
EPA JOURNAL
-------
uranium mills and another
ANPRM for underground
uranium mines to obtain
additional information on control
technologies.
Voluntary GM Recall
The General Motors Corporation
is voluntarily recalling
approximately 750,000 1981 and
1982 vehicles to repair catalytic
converters that may be defective.
California vehicles are included
in the recall.
The 1981 vehicles have V-8
engines built by both Pontiac
and Oldsmobile. Vehicles
included in the recall are the
Pontiac Bonneville/Catalina,
Firebird, Grand Prix, LeMans and
LeMans Safari Wagon; Buick
Century, Century Wagon and
Regal built with Pontiac 4.3 liter
(L) engines, as well as Buick
Electra, Estate Wagon, Custom
Cruiser Wagon, Delta 88,
Ninety-eight and Toronado
models built with Oldsmobile
4.3L and 5.0L engines.
The 1982 vehicles are
equipped with only V-8 engines
built by Oldsmobile. Models
involved are the Buick Electra,
Estate Wagon and Riviera; the
Oldsmobile Custom Cruiser
Wagon, Cutlass Supreme,
Cutlass Cruiser Wagon, Delta 88,
Ninety-eight and Toronado
equipped with 4.3L and 5.0L
engines.
All of the recall vehicles are
equipped with dual-bed catalytic
converters which have
experienced high rates of failure
due to the breakup of the
ceramic pellets within the
converters.
Voluntary Mazda Recall
The Mazda Motor Corporation
will voluntarily recall
approximately 47,000 vehicles to
service an emission control tube
that may deteriorate after contact
with road salt.
The voluntary recall campaign
will include all 1981 and 1982
Mazda 628 models currently
registered in the following high
salt usage states: Connecticut,
Delaware, Illinois, Indiana,
Maine, Maryland, Massachusetts,
Michigan, Minnesota, Missouri,
New Hampshire, New Jersey,
New York, Ohio, Pennsylvania,
Rhode Island, Vermont, West
Virginia, and Wisconsin. Vehicles
registered in the District of
Columbia will also be included.
The vehicles are equipped with
a steel tube that conveys air
from an air pump to the catalytic
converter which controls auto
emissions. This air provides
oxygen which facilitates the
reactions that occur in the
catalytic converter.
In areas of high salt usage
during winter months, the tubes
may corrode and may develop
leaks. If the tube leaks air, the
performance of the catalytic
converter will be impaired and
the vehicles may exceed
applicable federal emission
requirements for hydrocarbons
and carbon monoxide.
HAZARDOUS WASTE
Storage Tanks Advisory
EPA's Office of Toxic Substances
has issued a Chemical Advisory
to alert owners and operators of
underground storage tanks to
the potential problems that can
be caused when these tanks
begin to leak gasoline and other
motor fuels.
EPA has estimated that there
are approximately two million
underground motor fuel storage
tanks currently in use in the
United States. EPA's Chemical
Advisory discusses the potential
legal liability of the tank owner
or operator in the event of a
leak, the availability of insurance,
methods of detecting leaks, and
tank repair and replacement.
Approximately a quarter million
copies of this Advisory were sent
to interested groups throughout
the country.
Gasoline, other petroleum
products, hazardous wastes, and
other chemicals are stored in
above-ground and underground
tanks of varying sizes,
construction materials, and
designs. These tanks may be
operated at commercial gasoline
stations, farms, transportation
fleet headquarters, military
installations, and other facilities.
Preliminary data indicate that
leaking underground storage
tanks can cause ground-water
contamination, which may lead
to serious contamination of
drinking water supplies.
PESTICIDES
INTERNATIONAL
AFFAIRS
World Industry Conference
The United States participated in
the first World Industry
Conference on Environmental
Management (WICEM), which
was held on Nov. 14-16 at
Versailles, France. EPA
Administrator William D.
Ruckelshaus and U.S. Steel
Chairman David M. Roderick
were convenors for the
conference.
The French government was
host to the conference, which
was sponsored by world
industry in cooperation with the
U.N. Environment Program
(UNEP) and the International
Chamber of Commerce.
The United States, Canada, the
People's Republic of China,
Japan, Kenya, Zambia, and most
Western European and Latin
American governments were
represented at the conference by
ministerial level delegations.
Other participants included
organizations concerned with
environmental problems. The
primary industry sectors
represented at the conference
were pulp and paper, oil
production and electrical
generation, the chemical
industry, and iron and steel.
Emergency Pesticides
Exemptions
EPA intends through
negotiations with interested
parties to develop proposed
revisions to its regulations
permitting emergency uses of
pesticides.
An EPA project known as
"Negotiated Rulemaking," which
was first announced in the
Federal Register of February 22,
1983, will test whether, and
under what circumstances,
affected interest groups can
reach a negotiated consensus on
which the agency can base
Notices of Proposed Rulemaking
(NPRMs). EPA is exploring
whether this process can
produce better regulations while
reducing litigation and
uncertainty among affected
parties.
The agency recently began
addressing the emergency
pesticide exemption rulemaking
through "Negotiated
Rulemaking." In the fall of 1982,
the Office of Pesticide Programs
performed an internal audit of
the emergency exemption
regulations. A similar audit was
conducted by the House
Subcommittee on Department
Operations, Research and
Foreign Agriculture. Both reviews
raised concerns about the current
regulations and revealed that they
could be improved with some
revisions.
The Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA) allows the EPA
Administrator, at his discretion,
to exempt federal or state
agencies from certain pesticide
restrictions if he determines that
emergency conditions exist
which merit the broader use of a
particular pesticide.
DECEMBER 1984
31
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Appointments at EPA
TOXICS
PCB Transformer Fires
EPA has announced proposed
rules to reduce human health
risks from fires in electrical
transformers containing
polychlorinated biphenyls (PCBs).
Based upon EPA's evaluation
of recent transformer fires in
Binghamton, N.Y., San Francisco,
and Chicago, the agency believes
that the combustion of PCBs in
these transformers presents
significant risks to humans and
the environment.
To reduce these risks, EPA is
proposing an amendment to its
August 1982 PCB transformer
rules that will place additionai
controls on this type of
equipment.
PCB combustion can result in
the formation of polychlorinated
dibenzofurans (PCDFs). Tests on
rats have show PCDFs to cause
anemia and other blood
problems. When chlorinated
benzenes are present with the
PCBs, combustion can result in
the formation of polychlorinated
dibenzodioxins (PCDDs) as well.
PCDDs are a chemical family
that includes the dioxin
2,3,7,8-TCDD. This dioxin was
found in soot samples taken
after a Feb. 5, 1981, fire in
Binghamton and in the May 15,
1983, fire at the One Market
Plaza Building complex in San
Francisco.
PCB transformers are
frequently found in or near
apartment buildings, office
buildings, and shopping malls.
They may be located in
basements, or on floors of
buildings. The fact that the vast
majority of PCB transformers are
located in or near buildings
where pollution created by
combustion can enter areas of
high human occupancy is of
particular concern to EPA. ; .
Dr. Tudor T. Davies has been appointed
Director of EPA's new Office of Marine
and Estuarine Protection. This position
gives Davies responsibility for
administering the Marine Protection,
Research and Sanctuaries Act and for
such Clean Water Act issues as
incineration of hazardous waste at sea,
ocean dumping of sludge, and secondary
treatment waivers for sewage treatment
plants that discharge into marine waters.
Dr. Davies has been at EPA for over
13 years. He joined the agency in
November 1971 as a consultant in the
Office of Research and Monitoring, the
forerunner of today's Office of Research
and Development. For five years prior to
1971 he was an Associate Professor of
Geology at the University of South
Carolina.
After serving a year in the Office of
Research and Monitoring, Dr. Davies was
appointed Director of EPA's lab in Grosse
He, Mich. He held that position for three
years. In August 1975 Davies became
Deputy Director of EPA's Environmental
Research Laboratory in Gulf Breeze, Fla.,
where he worked for the next four years.
In December 1979 Dr. Davies became
Director of EPA's Environmental
Research Laboratory in Narragansett, R.I.
He returned to EPA headquarters in
January 1983 to become Director of the
Office of Program and Management
Operations in the agency's Office of
Water.
Dr. Davies studied geology at the
University of Wales (Swansea), where he
received his B.S. in 1960 and his Ph.D. in
1964.
Dr. Peter W. Preuss has been named
Deputy Director of EPA's Office of Health
and Environmental Assessment. In his
new position, he will assist Dr. Elizabeth
Anderson, the Director of that office, in
supervising technical assessment groups
at headquarters, in Cincinnati, and in
Research Triangle Park.
Dr. Preuss comes to EPA from the
Consumer Product Safety Commission,
where he has been Associate Executive
Director for Health Sciences for the past
five years. From 1974 to 1979 he was
Special Assistant to New Jersey's
Commissioner of Environmental
Protection and Director of the New
Jersey Toxic Substances Program.
During that time, Preuss also served as a
member, and then as Chairman of the
EPA Administrator's Toxic Substances
Advisory Committee.
From 1971 to 1974, Dr. Preuss was
Senior Scientist and Acting Deputy
Director at Israel's Environmental
Protection Service. For two years prior to
that, he worked as a research scientist in
the Department of Organic Chemistry at
the Hebrew University in Jerusalem. From
1967 to 1969, Preuss was a National
Institute of Health postdoctoral fellow.
Dr. Preuss studied chemistry and
mathematics at the Polytechnic Institute
of Brooklyn and at Brooklyn College,
where he received his B.A. in 1963. He
was awarded a Ph.D. in biology by
Columbia University in 1967.
Dr. Preuss is the author of numerous
scientific papers. In 1980 and 1983 he
was honored with the Chairman's Award,
the highest award of merit at the
Consumer Product Safety Commission. D
•'.'
EPA JOURNAL
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Snow-covered tree near Buffalo Mills, Pa.
Back cover: Skiing in Bolton Valley, Vt Risk
assessment and risk management are
concerned with protection of the natural
environment as we/I as public health (see
interview on p. />). Photo by Michael Philip
Manheim, Folio Inc.
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X ,
fii / /"- ' J
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