of
: Affairs (A-107)
lington DC 20460
Volume T1
Nun--
June 1985
-------
1/114
Reducing Risks
from Toxic Substances
El'A enijiloijce Kiltij Miller totes u /icriri/ /odd: i-
m/umr.s o/ die ('/irmi'ru/ Sub.sKntrr.s /nrr/ilonj. <"or;i/ji/rd
under auiliorini of the To.vic .Snb.siniuv.s ('ontrol Act. the
Inrenumi includes (laid o/i more r/inn ' fiemlca/s.
EPA lias major responsibilities
under Ihc Toxic Substances
Control Act to help protect
Americans from toxic chemicals.
In this issue, the EPA Journal
examines how these duties are
carried out.
The agency's policies anil
directions under the Toxic
Substances Control Act (TSCA)
are presented by Marcia
Williams, EPA's Deputy
Assistant Administrator for
Pesticides and Toxic
Substances. In an interview,
Don K. Clay, Director of the
Office of Toxic Substances,
discusses the issues involved in
administering TSCA.
EPA's program to reduce risks
from new chemicals is explained
and six observers of this key
TSCA component present their
views on its strengths and
weaknesses. Another article
describes how TSCA fills a major
gap in the federal government's
armament of environment
statutes.
A feature explains the science
behind TSCA—a storv of
detective work in parts per
billion. An article describes the
launching of a new toxics
control program to aid schools
in asbestos cleanup.
Concerning other issues,
excerpts are provided from a
recent speech by EPA
Administrator Lee M. Thomas
spelling out directions for the
agency. Another article in the
Journal series EPA Diary
reports on three days in the life
of an oil-scene coordinator on
an emergency.
An article describes EPA's
strategy to deal with toxic
chemicals in the nation's air. A
new "preventive medicine"
approach to ensuring
compliance with EPA rules is
reported.
In the ninth article in a
Journal series. EPA Region 8
describes its response to
pollution fears that swept a
Denver suburb.
The issue ends with two
regular features—Update and
Appointments at EPA, LJ
-------
United States
Environmental Protection
Agency
Office of
Public Affairs (A-107)
Washington DC 20460
Volume 11
Number 5
June 1985
«*EPA JOURNAL
Lee M. Thomas, Administrator
Josephine S. Cooper, Assistant Administrator for External Affairs
Paul A. Schuette, Acting Director. Office of Public Affairs
John Heritage, Editor
Susan Tejada, Associate Editor
Jack Lewis, Assistant Editor
Margheiita Pryor, Contributing 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-107). Waterside Mall. 401 M
St.. S.W.. Washington, D.C.
20460. No permission necessary
to reproduce contents except
copyrighted photos and other
materials.
Regulating Toxic
Substances:
An Overview
by Marcia Williams 'J
Issues in
Toxics Control:
An Interview with
Don R. Clay
Reviewing
New Chemicals
by Jack Lewis 6
Information:
TSCA's Cutting Edge
by Frank Kover 8
The Importance
of Billionths
by Miles Allen
and Roy Popkin 10
Debating EPA's
New Chemicals Program:
A Forum 12
Launching a
New Toxics Program
by Michael Stahl 16
Spelling Out
Directions for EPA
by Lee Thomas 18
On-Scene Coordinators
Don't Eat Quiche
by Susan Tejada
Protecting the Public
from Toxic Air
Pollutants
by David Patrick
Environmental Audits:
A New Enforcement Tool
by Richard Mays
Responding to a
Cancer Scare
by Rich Lathrop
Update 30
Appointments at EPA 31
Front cover: A worker takes a
chemical sample during the
production process at a plant in
Westville. N.J. EPA has a major
role in regulating industrial
chemicals under the Toxic
Substances Control Act. Photo by
Earl Dotter/American Labor
Education Center.
Design Credits:
Robert Flanagan:
Ron Farrah.
EPA Journal Subscriptions
The annual rate for subscribers
in the U.S. for the EPA Journal
is 820.00. The charge to
subscribers in foreign countries
is $25.00 a year. The price of a
single copy of the EPA Journal is
$2.00 in this country and $2.50
if sent to a foreign country.
Prices include mail costs.
Subscriptions to the EPA Journal
as well as to other Federal
Government maga/.ines are
handled only by the U.S.
Government Printing Office.
Anyone wishing to subscribe to
the EPA Journal should fill in the
form at right and enclose a check
or money order payable to the
Superintendent of Documents.
The requests should be mailed to:
Superintendent of Documents,
GPO. Washington. D.C. 20402.
Na
me
Firs
t, 1 ,
iSt
PL
EAS
»i: P
RINl
Co
npa
ny r>
arm
: or
Add
tion
al Ac
Idre
3S L
ne
Str
eet
^dd
ess
Cit
/
Sta
te
Zip
Coc
e
I I Payment enclosed (Make checks payable to Superintendent of Documents)
LJ Charge to rny Deposit Account No
-------
Regulating
Toxic Substances:
An Overview
by Marcia Williams
Society has become increasingly
dependent upon chemicals over the
last 40 years. Most of the products that
make our standard of living so high and
allow us a long and full life would not
exist without the benefit of the myriad of
chemicals produced by the chemical
industry, Yet even as we enjoy the
benefits of chemicals, there can be no
doubt that as a society we need to be
aware of and concerned about the
possible risks associated with exposure
to chemicals, whether in the workplace
or in everyday life. We need to balance
the benefits of a chemical against its
potential risk in deciding vvhether a
particular use of the chemical makes
sense.
I believe that we in government and
industry and environmental groups have
all done a relatively poor job of educating
the public about the various factors that
go into such a balancing. When we as
government regulators deal with
chemicals in a public way, we need to be
especially careful to explain the
trade-offs involved, rather than just
presenting the dry numbers found in
our risk assessments.
In some cases, people accept risks in
order to enjoy the benefits of a product.
Thus, the public by and large is willing
to accept the risk of a therapeutic agent
(such as a drug for chemotherapy) when
viewed in the context of the benefit it
will provide (hopefully, remission of
cancer).
But in most contexts people tend to
see risks In absolute terms, e.g.. if a
chemical is a "carcinogen," it is often
thought it should just be banned
without regard to the potential benefits
which It brings to society, the
magnitude of the risk from a particular
use (which can be quite small), and the
availability of safe (or safer) substitutes.
That is, the public seems to think that
the chemical should be banned unless
doing so would infringe too greatly upon
people's personal lifestyles, as in the case
of cigarettes, saccharin, or alcohol,
where, by and large, the public seems
willing to accept relatively large risks.
(Wiliitims i.s Deputy Assistant
AdministratorJor K/W's O//KV <>/
I'eslicides and 7'o.vrr Substances.I
.Vur.sr Socorm BalmeSprepares a patient's drucy ireatma
can::er. People arc n'illiny to (iccept certain chemical risks.
such as those posed by chemotherapy drnys. il they hetiec-
I/if benetits are irorth if.
It is in the context of balancing the
various factors about a chemical that
TSCA comes into the picture. TSCA is a
risk/benefit statute. Unlike some other
EPA offices, the TSCA office is not at
liberty to ban a chemical just because it
is a carcinogen, or causes any other
particular effect. We are charged with
the task of carefully balancing the
potential health and environmental
impacts of chemicals against the
benefits they bring to society. We are
only permitted to act when our analysis
of all the facts indicates that an
unreasonable risk is present.
That does not mean that we use a
strict mathematical model to balance the
various benefits of a chemical against its
potential risks in terms of lives lost,
chronic or acute diseases caused, fish
killed, etc. What it does mean is that we
need to be especially sensitive to the
conflicting values present in our society,
Thus, when we make decisions about
chemicals we think about such factors
as likelihood of harm and costs to
society (in terms of reduced standard of
living or effects on particular companies
or industries). At best, science will only
give us partial answers to the difficult
questions which we must address.
Common sense must be used to reach a
conclusion on whether and how
particular chemicals need to be
regulated.
TSCA contains a wide array of
statutory authorities to help us protect
public health and environment. EPA has
the power and authority to follow
chemicals from their first introduction
into commerce, through their life cycle,
to their ultimate disposal. We have
far-reaching and powerful
information-gathering tools. We are able
to require the testing necessary to allow
the federal government to make
reasoned decisions.
Also, we have the ability to evaluate
and take appropriate actions with
respect to multi-media chemical
problems. Looking at chemicals from a
cross-media perspective is quite
important because it helps to ensure
consistency among governmental
actions. Perhaps most importantly, it
also reduces the chance that a problem
found in one medium will just be
transferred to another. Finally, TSCA
has important preventive aspects—it
helps us to prevent some of tomorrow's
"Superfund" sites, the development of
new "PCBs" without any review by
government, and so forth.
I see a number of significant
challenges which we In the Office of
Pesticides and Toxic Substances must
meet over the next several years to allow
TSCA to achieve its full potential. We
have generally proceeded chemical by
chemical, but we will need to make more
effective and bold use of categorical
approaches to really make a dent in the
review of the 62,000 chemicals with
which we are confronted.
While we have a great deal of
information at our disposal, we have not
been as effective as we would like in
getting others to know about and use
our data. We have tended to focus our
attention on cancer but we need to
broaden our focus to consistently
encompass other health and
environmental effects. We need to devise
more efficient ways to require the
submission of testing and other data to
support our needs. Finally, we need to
devise more direct ways to be of support
to the other EPA programs (such as the
Office of Ground-Water Protection in the
implementation of its ground-water
strategy).
I am confident that TSCA's goal of
protecting society and the environment
from unreasonable risks from chemical
substances is obtainable and that it will
be even more fully realized as we
continue toward TSCA's full
implementation. D
EPA JOURNAL
-------
Issues in
Toxics Control
An Interview With
Don R. Clay
As Director of EPA's Office of Toxic
Substances, which he has headed
since 1981. Don R. Clay is
responsible for developing and
operating programs to assess and
control hazardous chemicals under
the authority of the Toxic
Substances Control Act (TSCA).
TSCA, passed in 1976, empowers
the federal government to perform
three basic functions for the
protection of public health: first, to
gather information from chemical
manufacturers concerning
chemicals currently in use and
those proposed for future use:
second, to review new chemicals
prior to commercial or industrial
use: third, to regulate chemicals
judged to pose unreasonable risks
of injury to human health or the
environment.
TSCA does not cover foods, drugs,
cosmetics, or pesticides, but its
authority does embrace virtually
every chemical used in the U.S.
today, whether domestic or
imported.
The EPA Journal asked Clay to
share some of his insights into
EPA's TSCA program, both its
achievements to date and its future
direction:
% *
How does TSCA differ from the
other environmental statutes
administered by EPA?
A
Most EPA statutes are organized by
media. That is, a statute such as the
Clean Air Act focuses attention on issues
involving emissions to air. the Water Act
is concerned with discharges to water,
etc. TSCA, on the other hand, is not
specific to any particular medium. It
allows us to focus on all possible routes
of exposure, arid follow chemicals from
cradle to grave.
Why would Congress pass a law
at cuts across all the particular
media with which the agency is
familiar?
/x Well, I think Congress saw that
chemicals often present multi-media
problems. One chemical can be a
problem in the air, in the water, in the
workplace, etc. I think Congress was
looking for a place that could analyze the
problem in all the media and then try to
figure out an appropriate strategy.
Which could mean referring the
chemical to another agency. Or it could
mean that EPA would do its own
regulation of the chemical under either
TSCA or the other EPA statutes
depending on what made the most sense
in the particular circumstances.
TSCA was formed about eight
years ago, and yet it isn't as
well-known as some of EPA's other
programs. Why is that?
i
*r
^^^&
•
Laboratory animals plaij cm important
role in chemicitl U\sn'ruy that can he
reifiiired under the Toxic
Control Act.
i\ A lot of the things we do are not as
much in the public eye as many other
EPA actions. For instance, if there's a
Superfund site near your house, that's
something that gets a lot of attention. If
TSCA requires that a low-volume
chemical be tested, that's helping society
because someday that chemical may be a
high-volume chemical, but in terms of
the public attention or interest in such
an action, there's very little.
Could you tell us a little bit about
the information you have gathered
under TSCA?
/v A great deal of significant data has
been gathered under TSCA.
First, we have produced the only
complete inventory of industrial
chemicals in commerce in the United
States. This involves over 62.000
substances and excludes only foods,
drugs, cosmetics, or pesticides. The
inventory also gives underlying
information on those chemicals. It'll tell
you generally what the production
volume is, where it's manufactured, and
other very basic information.
Second, we have more detailed data on
the production, use, and emissions of
over 300 chemicals, many of which are
chemicals on the action lists of other
EPA programs. Examples include
toluene, methylene chloride, various
phthalate esters, and more specialized
chemicals such as alkyl tins. We have
JUNE 1985
-------
unpublished health and safety data
(including monitoring data) on the same
group of chemicals. There currently are
over 7,300 studies in our files on these
chemicals.
Finally, we have a very active chemical
testing program that allows us to require
Industry to conduct whatever health,
environmental, or exposure testing we
(or anyone else in the agency) need if
certain basic findings are made. To date
we have taken action on over 500
chemicals, and received over 400 new
health or environmental effects tests.
How does your new chemical
review program work and what
chemicals are covered?
A
The law requires that 90 days
before any company can manufacture or
import a chemical which is not on the
Inventory, it must notify us. We call this
premanufacture notification or "PMN". If
we identify problems, we can order the
company to test the chemical and we
can require controls pending testing.
In the period since this program began
in 1979, we have reviewed nearly 5,000
PMN submissions. We are currently
receiving about 1,200 chemicals a year
for PMN review. Last year we regulated
47 chemicals received in the PMN
program. Whenever issues arise during
PMN review that might affect other EPA
programs, we make it a point to consult
with them. We also are issuing follow-up
rules for PMN chemicals which, while
not presenting an unreasonable risk
during their initial introduction into
commerce, would be of concern to us if
the production volume increased
significantly, if the uses changed, or if
certain control practices were not
followed.
You mentioned that you also act
to prevent unreasonable risks posed by
chemicals. What does the term
"unreasonable risk" mean?
A
There's no clearcut definition of
unreasonable risk, but it involves a
balancing process. The Act does not seek
absolute safety, realizing that that would
be an impossible goal. Instead it takes
the concept of risk and puts it into the
real world. It does this by taking into
account factors such as the health and
environmental effects of the chemical,
the exposure to the chemical, the
economic value of the chemical, and the
cost of regulation. EPA is then asked to
balance these factors and determine
whether the chemicals under evaluation
present an unreasonable risk, and if
they do, to limit those risks.
What kinds of action have you
taken to limit such risks?
/A First, let me state that there are a
variety of ways in which we can act.
There is the direct exercise of regulatory
authority, ranging from banning a
chemical to requiring simple labeling
changes. Second, we can decide that the
type of problem identified can best be
resolved using a different statutory
authority and refer the chemical to
another agency or program. Finally, we
have issued what we call "chemical
advisories".
With respect to direct control actions,
we have issued a variety of rules
concerning the use and disposal of
PCBs: regulated aerosol use of
chlorinated fluorocarbons; and regulated
the disposal of dioxin-containing
materials. We have issued a rule
requiring local schools across the
country to check to see if their buildings
contain asbestos in what we call a
"friable" form, that is, in a form which
crumbles when you touch it. If they have
friable asbestos, they have to notify
parents and employees. There didn't
seem to be any other authorities in the
government that could deal with that
type of issue, so it was a good use of the
TSCA authorities.
We are also in the final stages of
evaluating control needs for various
other chemical substances, including
4.4-methylenedianiline, MBOCA.
nitrosamines in metalworking fluids,
formaldehyde, glycol ethers,
1,3-butadiene. and asbestos. About 60
other chemicals are in various stages of
our detailed evaluation process.
What are these chemical
advisories you mentioned?
•iv Chemical advisories are
non-regulatory documents which advise
the public and affected industry about
the likely risks posed by particular
chemical substances, giving practical
ways to minimize the risks. We have
issued advisories on used motor oil,
nitrosamines in cutting fluids, leaking
underground storage tanks, and
P-TBBA.
y What would you say your key
priorities for TSCA are right now?
/\ I would say that the first thing we
need to focus on is getting more test
data on existing chemicals. We are
getting a fair amount of test data now,
but I think that we should be able to get
data on a considerably larger number of
significant chemicals in an easier way,
both for us and industry. I also think
that one of the things that's very
important for us to do is to make a
clearcut decision on how we fit with
other federal agencies and EPA programs
in terms of controlling chemicals that
present unreasonable risks. Those are
the two things that are really important
to us now.
In the new chemical area, I would say
that the program we have now is an
evolving one, but I don't anticipate any
dramatic changes in that area. Our goal
is to get more data on new chemicals
without unnecessarily impeding
innovation.
Has the existence of TSCA
changed the way manufacturers in
America do business?
r\
Well, I think that especially in the
new chemical area it's had an impact.
We've been told by several companies
that the mere fact that a company has to
let the government know 90 days before
it intends to manufacture these
chemicals means that some companies
are not going to be manufacturing some
"nasty" chemicals. Just our very
existence has had that generally positive
effect. In addition to that, the fact that
we are reviewing new chemicals means
that companies must take that into
account. We believe that this has led to
more testing being conducted prior to
introduction into commerce. Companies
tend to look at the issue of whether or
not a new chemical presents an
unreasonable risk more carefully than
they did before because of the existence
of TSCA.
EPA JOURNAL
-------
TSCA Compliance Program
Enforcement of the Toxic
Substances Control Act {TSCA) is
carried out by personnel in EPA's
ten regional offices. Regional
offices target, schedule, and
conduct compliance monitoring
inspections at facilities subject to
TSCA requirements for PCBs,
asbestos, chemical testing and
reporting, importing, and
premanufacture notification.
In Fiscal Year 1984. EPA, along
with four state agencies (Ohio,
Massachusetts, Connecticut, and
Maryland) cooperating under the
terms of enforcement grants-in-aid,
conducted 1,440 PCB compliance
monitoring inspections. With the
American Association of Retired
Persons and the State of California
operating under cooperative
agreements, EPA also conducted
1,945 asbestos-in-schools
inspections. Additional compliance
inspections were made lor
chlorofluorocarbons, dioxin.
premanufacture notification,
chemical testing and reporting.
and imports.
Where violations of TSCA are
identified, EPA may levy either
administrative or criminal
penalties, as well as civil actions to
compel compliance. In FY
1984, most of the enforcement
actions involved violations of the
PCB rule, the asbestos-in-schools
requirements, and
premanufacturing notification
requirements. The agency filed a
total of 283 administrate
complaints as a result of PCB
inspections, eleven complaints
were issued for violations of the
premanufacture notification
requirements, and 82 complaints
were issued for violations of the
asbestos-in-schools requirements.
At mid-year in FY 1985. the
regions have conducted 2,517
TSCA inspections and have issued
309 complaints. The compliance
accomplishments achieved by the
cooperative efforts of regional and
headquarters personnel and state
agencies reflect the high priority
given to enforcing the various
sections of TSCA.
Voj Do you think that this has had an
adverse effect on innovation?
-rx We have had an impact on
innovation, but we generally find it to be
minor. There are some specialty
chemical companies that need to deliver
chemicals on a week's notice. And if
these are new chemicals, that creates a
problem, because EPA makes them wait
at least 90 days. We have done two
things about this. We've issued an
exemption for chemicals manufactured
in small quantities (under 1,000
kilograms per year) and another
exemption for certain kinds of low-risk
polymers. But other than that, I think
most people would agree that it is really
important to make sure that new
chemicals get a close look, and we do
that. In other areas, our evaluations
show only the most minimal of effects,
except where prohibition of manufacture
or use is clearly called for. In these
instances there is a significant boost to
the development of safer substitutes.
Is the information that you have
proving to be useful to other parts of
EPA or other federal agencies, even
state agencies?
•f\ Yes, and we are looking to increase
the flow of information to other agencies
and to the states. An example is
asbestos, where we required all the
asbestos manufacturers and most of the
processors to identify themselves and to
tell us how much exposure there was to
how many people and so forth. That was
an important rule, and we got a
tremendous amount of information
which we made available to the
Occupational Safety and Health
Administration and to various parts of
EPA. We also make risk information
available to the states and to other parts
of the agency. We have computerized
data bases: we do qualitative risk
assessments, chemical hazard
information profiles, and a wide variety
of other information that we make
available.
Q
Is there a danger that in carrying
out TSCA, EPA will interfere too much
with the marketplace, become too
much of a presence in the
marketplace?
A
1 don't think so. If we were seeking
a zero risk from these 62,000 chemicals,
then I think that there would be
potential to have undue impacts. But
TSCA takes into account the impacts on
innovation, the impacts on the economy,
and so forth, while nevertheless
preventing unreasonable risks. We do
see our primary job as dealing with risks
that are unreasonable, and dealing with
them in the least burdensome way that
will accomplish the goal of protecting
our health and environment.
Q
The TSCA program has been
underway for several years. Do you feel
that TSCA needs amendments to make
it work better?
A
I think TSCA is a very rational
statute. The notion of dealing with
unreasonable risks and not seeking a
risk free society makes a lot of sense.
The only area that 1 think we ought to
look at is the procedures under TSCA. I
can get done what 1 feel needs to get
done, but it takes me longer than I'd like
it to take.
The last question is: Do you have
any further comments that you'd like
to make?
A Yes, 1 think that TSCA is a stalule
that has just begun to realize its
potential. It has incredible potential
because it has a wide array of unique
authorities to gather information, to
have chemicals tested, to have
companies identify the chemicals which
they manufacture, and to control
chemicals posing unreasonable risks. I
would look for TSCA over the next
several years to have a more active and
visible role, especially in the
information-gathering area. LI
JUNE 1985
-------
Reviewing New Chemicals
by Jack Lewis
We all live in a safer world because of
TSCA's new chemicals program. The
purpose of this program is to identify
chemicals that might pose unreasonable
risks and require that they be controlled
or tested before they are used extensively
in the United States. Congress
instructed EPA to carry out this task
without unduly impeding new chemical
innovation.
Under TSCA—which became law on
January 1, 1977—manufacturers and
importers are required to notify EPA 90
days before they intend to manufacture
or import any new chemical for
commercial purposes. The notification,
called a PMN, must contain certain
information and be filed on a special
form. New chemicals are those that are
produced or imported in the U.S. and
are not listed on EPA's 1979 Inventory of
Existing Chemical Substances. About
5,000 new chemicals have been reviewed
by EPA since the program was put in
place in the summer of 1979. In FY
1985, the agency expects to review at
least 1,500 new chemicals.
Section 5 of TSCA gives EPA a wide
range of responsibility for regulating
new chemicals. The statute requires the
agency to review new chemicals for both
health and environmental effects
throughout their total life cycle. Thus,
the agency reviews the potential effects
in the factory, water, air, and at disposal
sites. Consumer exposures are also
carefully reviewed.
The review of a new chemical must
take place in an atmosphere of
considerable uncertainty. A high degree
of certainty can only be obtained from a
wide range of tests for both health and
environmental effects. Because of the
(Lcici.s is /Ys.siskini Editor ot the I-'.PA
Journal)
high costs associated with such testing
(often well over one million dollars), it is
not practical to require such testing on
most new chemicals. Therefore, data
from similar existing chemicals are used
to identify potential hazards of new
chemicals.
Because new chemicals vary so much,
decisions on what testing is appropriate
for a given chemical are made on a
case-by-case basis. This allows the
agency to focus its resources and the
resources of industry on chemicals of
potential concern.
Teams of highly trained EPA experts
conduct the EPA's PMN review of new
chemicals. The agency's new chemical
program has a matrix organization that
brings together chemists, chemical
engineers, pharmacologists, oncologists,
economists, and other specialists. They
evaluate and weigh the new chemical's
possible risk to public health and
environment as well as the economic
benefits of the substance.
As of June 1985, more than 200 PMNs
were identified as potentially posing
unreasonable risks. All have been
subject to some kind of agency
regulation. In nearly 100 other cases,
industry has voluntarily completed
toxicity studies to address EPA concerns
about possible health risks.
One significant group of EPA-regulated
new chemicals are corrosion inhibitors
used in metalworking fluids. EPA found
that when nitrosating agents are added
to these formulations, nitrosamines are
formed. These are powerful carcinogens.
Acting under Section 5 of TSCA, EPA
issued immediately effective bans on the
addition of nitrosating agents to four
new corrosion inhibitors used in
metalworking fluids. The agency is also
conducting a regulatory investigation of
similar existing chemicals used in
metalworking fluids. In addition, EPA
issued chemical advisories on similar
existing corrosion inhibitors to let users
know about the problem.
What about the roughly 4,700 new
chemicals EPA has decided no( to
regulate? It turns out that these
EPA JOURNAL
-------
Only authorized personnel
u'trh computer coded III curds
can enter the /-"P.-\ storage area
for neic chemical data.
The information
is protected under t!\e
Confidential Ihisiness
Information clause
of the Toxic Substances
Control Act.
chemicals do not appear to present any
significant risks under the conditions of
use. If the intended use of new
chemicals could change to a riskier one,
then EPA issues a Significant New Use
Rule which allows EPA to review the new
use and regulate, if necessary.
EPA has issued two broad exemptions
for new chemicals. The first covers high
molecular weight polymers which
constitute roughly 25 percent of the
PMN's filed with EPA. These substances,
used in the manufacture of plastics and
other products, are generally viewed as
posing little or no risk to health or the
environment. Consequently. EPA has
recently exempted them from the
standard PMN review process by
providing for a shortened notification
and review period.
The second exemption covers low
volume chemicals produced at less than
1,000 kilograms. These constitute
approximately 20 percent of the PMNs
filed. As with exempted polymers, EPA
has introduced a streamlined 21-day
notification and review process. The
exemption stipulates that producers of
low-volume new chemicals must undergo
the full 90-day review should future
production volumes rise above 1,000
kilograms.
TSCA's new chemicals program has a
proud record of achievement and a
promising future. EPA will continue to
zero in on problem chemicals. As a
result, the American public can look
forward to even better protection in the
years ahead. D
JUNE 1985
-------
Information:
TSCA's Cutting Edge
by Frank Kover
When a "chemical of the week" like
formaldehyde or methyl isocyanate
hits the news, EPA's Office of Toxic
Substances JOTS) is flooded with calls
for additional information. More and
more, other program offices in EPA,
other government agencies, and a variety
of non-government organizations rely on
the unique information data bases of the
Toxic Substances Control Act (TSCA) to
help serve their data needs.
Until Congress designed and enacted
TSCA, a notable deficiency in the federal
government's armament was the
authority to gather the exposure data
and toxicological information needed for
reliable assessments of the risks
presented by chemicals to human health
and the environment.
Risk assessments require information
on both exposure and hazard. The use of
chemicals usually involves both exposure
and hazard to varying degrees, and EPA
considers the magnitude of both
components in order to assess the risk.
For chemicals now in commerce, TSCA
concentrates data-gathering authority
mainly in two sections: in Section 8,
which requires industry to report certain
existing information to EPA and keep
records; and in Section 4, which enables
EPA to require testing by industry. Also,
Section 5 requires that information be
submitted when industry' develops new
chemicals and significant new uses of
certain existing chemicals.
Notices of Substantial Risks
The first reporting requirement under
TSCA was effective with the Act on
January 1, 1977. When industry obtains
new information indicating that a
chemical presents a substantial risk of
injury to health or the environment. EPA
must be notified immediately. Since the
effective date of TSCA. more than 540
initial submissions have been received
by EPA and given priority evaluation and
follow-up attention. In addition.
companies have volunteered more than
390 "For Your Information"
submissions.
Substantial risk notices often include
preliminary findings from toxicity
testing programs, such as cases of
excess tumors developing during the
course of a study on rats or mice. Other
notices may report untoward effects on
humans in the workplace, or ecological
effects data, while a few have reported
ground-water contamination.
EPA's implementation of this provision
has brought about heightened industry
awareness of potential chemical risks.
For example, many companies reported
that in direct response to their
submissions, they voluntarily took action
to notify workers, customers, and
others; changed labeling and handling
practices; initiated further toxicity and
exposure studies; or ceased production.
Filing Allegations
Another TSCA regulation requires the
chemical industry to keep records of
alleged "significant adverse reactions" to
chemical substances and mixtures. An
allegation is a statement of an
individual's belief that a chemical
substance or mixture has caused harm
to him or her, another person or
persons, or to the environment. Proof or
evidence is not required, but written
allegations must be signed and there
must be a link between the substance or
process involved and the claimed effects.
The allegations can be made to the
company by employees, their unions.
health authorities, plant neighbors, or
other parties. EPA can inspect the files
and request copies of the allegations.
Subsequent investigations by
companies as a result of receiving
allegations have sometimes involved
additional test findings or identification
of a pattern of effects. Such results have
led to submission of notices of
substantial risk.
Since almost anyone anywhere has the
right to file these allegations, EPA has
undertaken an outreach program to
extend awareness and understanding of
the rule.
TSCA Inventory
A major early task under TSCA was to
compile an inventory of all chemicals in
commerce in the United States. EPA
published the first issue of this TSCA
Chemical Substances Inventory in 1979,
based on information reported by
domestic manufacturers and importers.
The inventory numbers more than
62.000 chemicals that are now or have
been in commerce at any time since
January 1, 1975.
The inventory provides a listing of
substances according to chemical name,
synonyms, molecular formula, and a
unique accession number or Chemical
Abstracts Service Registry number for
each: and information on production
volume, plant location, and whether the
substance is site-limited or shipped from
the production site.
Since the inventory has become
increasingly outdated, the agency
proposed recently to update its most
critical elements. Under these new
provisions, data will be updated every
two years where production has changed
significantly.
o/ i/ic ('i
Scrrciimi/ linuuli in the .
(Virmirn/ .•Vs.sc.ssmrril Division o/
O/'/icv o/ /'
EPA JOURNAL
-------
EPA employee Kenneth Bnckner ctiecks
a clicmical reti-rence niamiiil. The
O/'/iYc1 <)/ To.vtr Substances cutulociucs
Information on lo.vic clu'miruJs irhicn is
used by EPA and other aycncics.
Health and Safety Studies
EPA can require chemical companies to
submit unpublished health and safety
studies on chemical substances and
mixtures. Respondents to these rules
must submit two types of data: copies of
studies in the possession of, or available
to, the company: and lists of ongoing or
completed studies that the company
knows about, but does not have.
By using a "model rule." EPA is able to
ensure, in a relatively easy fashion, that
it has all available unpublished health
and safety data on specific chemicals of
concern. A model rule is used by simply
adding those chemicals for which
reporting is desired to an established list
of reporting requirements. Reported data
are used to assess potential risks and, in
some cases, to support decisions about
whether to require industry to test those
chemicals when data are insufficient.
Data-Gathering
TSCA also allows the collection of
production, use, and exposure data from
chemical companies, and can be used to
require the retention of certain records.
Because rulemaking is often a lengthy.
difficult, and expensive process, EPA
developed a "model rule" to collect the
basic, readily obtainable data needed for
preliminary risk assessments on
specified substances. To date, EPA has
used this rule to gather data on
approximately 350 chemical substances.
The agency now is planning a second
model rule to gather more detailed
information. To be called the
Comprehensive Assessment Information
Rule, its reporting form will include an
extensive list of questions for which
answers by chemical companies may be
required. Each time data are needed
EPA will amend the rule by adding the
subject chemicals and identifying the
specific questions to be answered.
Toxicity Testing
As a result of ongoing OTS evaluations,
some existing chemicals will be found to
have insufficient data available on them
to allow an assessment of risk. In such
cases, OTS may require toxicity testing to
develop the needed data. In addition, the
Interagency Testing Committee (ITC).
created by TSCA, periodically
recommends to EPA priority lists of
chemicals for which toxicological (or
other) testing may be necessary. When
the ITC designates chemicals to EPA,
OTS collects basic production and
exposure data and health and safety
studies. Where data collected are
insufficient to characterize risk, OTS
may require development of the needed
data through appropriate testing.
Follow-Up Activities
Of growing importance is the Office of
Toxic Substances follow-up program.
After a preliminary assessment of a
chemical's risk, OTS may defer
regulation because of a low or unknown
degree of exposure concern. In such
cases, follow-up monitoring of future
uses of the chemical by rule will ensure
that the agency is made aware of
potential increases in the exposure.
which in turn may indicate increased
risk. This affords EPA an early
opportunity to act if necessary to reduce
potential risks. D
JUNE 1985
-------
The Importance of Billionths
by Miles Allen and Roy Popkin
At the Midwest Hem-arch Institute
in Kansas Citu. .\/<>..
analyticut chemist Maryie \Vickhani
injects an extract from n water sample
into a c/a.s chmmcilMiraph
mass spectrometer. She is measuring
minute qitiintili'-s <>/
chlorinated dio.vm.s.
Tmagine yourself sipping from a freshly
Ibrewed cup of coffee while standing
beside a 50-meter Olympic-sized
swimming pool. A competitor climbing
from the pool jostles your arm slightly
and a few drops of coffee splash into the
water. As you watch, the spot of Java
quickly diffuses into the pool. Now
imagine returning several hours later,
after scores of swimmers have assisted
the mechanical pumps in churning the
pool so that your small splash of coffee is
evenly distributed throughout more than
200.000 gallons of water. Taking a clean
cup, you scoop up some water and
examine it. You cannot see any coffee
color. You cannot taste any coffee flavor.
And you certainly cannot detect any hint
of that lovely aroma. You may think that
no one could ever tell that any coffee had
spilled in that enormous pool.
In reality, you'd be wrong. There would
be about one part of coffee per one
billion parts of pool water in that cup,
an amount which scientists could
readily find with today's technologies.
But why should anybody care? Certainly,
such small amounts could be of no
significance. . . Wrong again! Consider
this information from a recent EPA
publication on dioxln:
"The Centers for Disease Control
considers one part per billion of dioxin
in soil to be a level of concern in
residential areas. The Food and Drug
Administration recommends . . . not
eating any fish with greater than 50
parts per trillion of dioxin." (To reach a
ratio of 50 parts per trillion, you would
have to spread your coffee droplets
through 20 swimming pools.)
i Ml en and !\>pkin arc on tlic slat! ql the
Office 0) i'nhiic Allans.)
Like searching for a needle in a
haystack? If you had a rather large
haystack, the proportions would be
about right (one billion needles would fill
approximately 10 cubic yards) but the
task is even more difficult because the
"needle" would be broken up into almost
infinitely small pieces scattered
randomly throughout the stack.
Not too long ago, determining the
presence of chemicals in such small
proportions was not possible. As recently
as 1972, EPA was forced to cancel
hearings on dioxin because the
analytical technology was insufficient to
determine risks. Yet it took only five
years to remedy that situation, and
today scientists are measuring some
substances at levels of parts per
quadrillion. (A quadrillion is a thousand
trillion, or a million billion.)
Even when dealing with substances
that are not toxic in such small
amounts, the need to measure minute
levels remains. Some chemicals tend to
accumulate in the fatty tissues of
humans so that, in time, even the
tiniest amounts may build to dangerous
levels.
The main tool used by EPA sleuths on
the trail of toxic contaminants is
gas-liquid chromatography, coupled with
either an electron-capture detector or a
mass spectrometer to identify the
chemicals in the specimens. The
electron-capture detector is extremely
sensitive for detecting small amounts of
material, while the mass spectrometer
provides a unique signature for each
residue detected. A key element in the
improved ability to detect trace
quantities of chemicals is the agency's
development of procedures to remove
unwanted materials from the specimen
prior to its analysis with gas
chromatography.
EPA's scientists have often employed
these high-tech methods to determine
levels of a particular chemical. For
example, the General Services
Administration once requested a study
of PCB levels in the blood and tissue of
government electricians who worked
around transformers containing the
toxic substance. Or, the scientists may
search for numerous chemicals, as in a
recent study of milk samples from
mothers residing in industrial urban
areas.
In both cases analytical techniques
capable of measuring chemical residues
at the parts per billion level were
required.
The agency's detection skills have been
utilized in international projects, such
as a recent seven-nation program
seeking to determine the levels of lead
and cadmium in the blood of people not
occupationally exposed to those metals.
The study, which used atomic absorption
spectrometry, was done in collaboration
with the World Health Organization and
the United Nations.
Whether used to discover levels of
contaminants in exposed populations, or
to establish baseline data for
comparisons (see box), or to determine
the relationship between dose rates and
medical problems, the ability to measure
residues present at the parts per billion
level can be helpful in assessing
environmental risk. Most of
us cannot even conceive of a
quadrillionth of anything. So it's
comforting to know that there are
scientists capable of scouting the
micro-frontier and alerting us to the
molecular dangers hiding there. D
10
EPA JOURNAL
-------
Discovering What We're
Made Of
In order to protect the public health
through sensible and effective
regulations. EPA must often set limits
on how much of a given substance may
be discharged into our environment. To
determine limits, it is helpful to have
information on the amount of a
substance in the environment and the
amount taken into, and retained by. the
human body. This requires a clear
picture of what chemicals are normally
in the body and at what levels they occur
throughout the population.
It is difficult to say whether a specific
source of contamination—sewer pipe.
smokestack, waste dump, or
whatever—has actually contributed to
increased levels of a toxic substance in
the exposed population without having
baseline data available for comparison.
To establish these baseline data, EPA
operates a continuing human tissues
monitoring program. The Exposure
Evaluation Division of the Office of Toxic
Substances (OTS) runs the program,
which obtains specimens from a
network of pathologists and coroners
around the country. About 45 such
sources are used each year, with
approximately 1000 adipose (fatty) tissue
specimens collected on the basis of
demographic requirements and specified
as not to come from individuals who
worked in the chemical industry or who
were involved in a hazardous materials
accident.
Tissue samples typically weigh about 5
grams (approximately the size of a large
grape). They are packed in chemically
clean containers provided by EPA and
shipped frozen to designated
laboratories operating under EPA
contracts. Over two-thirds of the
specimens tested each year come from
autopsies, the remainder from routine
surgical biopsy procedures. All are
collected in accordance with Department
of Health and Human Services
requirements on privacy and informed
consent.
The primary goal of the tissue
sampling program is to establish the
distribution of levels of selected toxic
chemicals in a national cross-section of
the U.S. population, which allows
comparisons based on age. sex, and
place of residence. Martin Halper,
Director of EPA's Exposure Evaluation
Division, is looking for OTS to expand
the program in 1986 and 1987 to
include blood and mother's milk
specimens as well as to broaden the
range of TSCA-related chemicals being
analyzed.
JUNE 1985
11
-------
Debating EPA's New
Chemicals Program:
A Forum
What are the strengths and
weaknesses of EPA's effort to reduce
risks from new chemicals? EPA
Journal asked six observers with
different vantage points to
comment. The answersJollow:
Dave Durenberger
U.S. Senator (R-Minn.)
Chairman
Toxic Substances and Environmental
Oversight Subcommittee
Senate Environment and Public Works
Committee
The public has a right to expect that
the EPA is making good on the
promise of the Toxic Substances Control
Act that newly marketed chemicals will
not later harm public health or the
environment.
Like the preacher's wife, the new
chemical review program should be
above reproach. Not only should it fulfill
its mission, it should be beyond doubt
that it is doing so.
How does the program measure up to
this goal? Not well, I fear, and the fault
lies as much with Congress as it does
with the agency. Consider these facts:
• Staff levels have remained steady while
the number of chemicals that require
assessment has increased dramatically
since the program's inception:
• At the present time, the agency must,
on the average, perform a new chemical
assessment and reach a decision every
90 minutes;
• Half of these assessments are
performed without benefit of any toxicity
data whatsoever;
• Voluntary new chemical testing
guidance issued over four years ago has
been ignored:
• Virtually a]J risk-relevant data that are
included in premanufacture notices are
screened from public view by the
industry's blanket claims of
confidentiality.
The message from the industry and
the agency is simply this: "Trust us.
Trust us to make reliable assessments
without benefit of data and with only
sketchy ideas of future uses and amount
of exposure." And that is the program's
major disadvantage. It is a black box. No
one outside the process can know how
decisions are made. No one can tell
whether it is working well or not. 1
would venture to say that informed
critics will continue to question the
integrity of decisions made inside that
black box until they see more data going
into it and glimpse its internal decision
machinery.
Perhaps the major advantage of the
present program is simply that it exists.
Chemical industry officials have told me
that the prospect of taking a potential
new product to EPA for review has
changed substantially the way
companies make product research and
marketing decisions. Many new
chemicals that once would have been
marketed now are laid aside because
they are unlikely to pass muster with the
agency. Even so, dozens of new
chemicals have been blocked or
restricted by agency action. But how
many that should have been restricted
have passed undetected because of
inadequate test data? There is no way to
know.
Considering the burdens placed on the
agency and the inability to require
needed risk data, I believe the able and
dedicated agency staff has made a good
showing. The agency should continue to
develop the authorities it already has in
present law, and Congress should
consider improving those authorities,
especially as they relate to new chemical
test data and confidentiality. Only then
can the agency and the regulated
industry give credible assurances that
the program is working as intended.
Ronald A. Lang
Executive Director
Synthetic Organic Chemical
Manufacturers Association
Despite what one sometimes reads in
the press, we at the Synthetic
Organic Chemical Manufacturers
Association (SOCMA) believe it is
abundantly clear that the Toxic
Substances Control Act is working. New
chemicals which pose unreasonable
risks to public health or the
environment are not reaching the
market and the objectives of Congress in
passing TSCA more than seven years ago
are being met. Questionable chemicals
are not making it through the
premanufacture notification (PMN)
process or, in many more cases, are not
even being submitted for review because
adverse effects show up in company
testing programs.
In my view, it is extremely important
to keep this perspective clearly in rnind
as Congress considers possible
amendments: TSCA is working, and
probably working better than
comparable laws anywhere in the world.
At the same time, however, there are
areas where the experience of the last six
years has made it clear that some
changes in the law, the regulations or
their interpretation can help to improve
TSCA's effectiveness in ensuring public
safety while at the same time
minimizing the burden on an American
industry in the midst of a tough
worldwide competitive struggle for
markets.
12
EPA JOURNAL
-------
As an association, one of SOCMA's key
roles parallels that of Ihe agency—
making certain our companies, most of
which are small to medium-sized.
understand the complex regulations and
find ways to comply without seriously
weakening the innovation which is so
critical to many of them.
From that perspective, we believe the
agency's recent decision to provide an
exemption for small-volume chemicals
which clearly do not pose a public health
risk is a significant step forward. It will
remove an important millstone which
has slowed new product development
over the last few years as lines of
research have been abandoned because
complexities or costs of a formal PMN
process simply could not be justified.
One area where the agency's approach
is continuing to cause problems for
SOCMA's members involves the
increasing use of Section 5(e) as a
regulator}' mechanism. This in effect
delays PMN approvals for the significant
period of time necessary for the PMN
submitter to negotiate and EPA to
approve a consent order.
It is important for EPA to continue to
work closely with industry, public
interest groups, and others in better
defining the kinds and quantity of data
needed to do effective PMN reviews, how
to handle new or growing use of
particular chemicals, and how best to
apply Section 8 to gather necessary
information. SOCMA is already talking
with such groups about the changes
Congress should consider in
reauthorizing TSCA; such a "reasoning
together" process can be a very effective
way of making the system work.
We continue our commitment to
working with Congress and the agency
in ensuring that our members meet both
the letter and spirit of TSCA while at the
same time finding ways of doing so
which will not threaten the viability of
the hundreds of companies which make
up the organic chemical industry in this
country. Despite occasional
disagreements, we believe TSCA is
working, we believe the agency is doing
a good job under very difficult and
complex conditions, and we hope
cooperation rather than confrontation
will form the basis for addressing
legitimate public concerns in the future.
Sheldon Samuels
Director
Health, Safety, and Environment
Industrial Union Department,
AFL-CIO
A five-year legislative campaign was
waged by environmental and labor
organizations to pass the Toxic
Substances Control Act. After nine years
of implementation, what have we
accomplished?
The labor movement wanted to
stimulate basic changes in the direction
of chemical innovation, manufacture,
and use. It wanted the generation of,
and access to, more information.
Generic market and pre-market
regulation of chemicals was seen as an
expected result of complementary social
and technical paths: research.
enforcement, testing, and information
dissemination. Labor wanted these
objectives achieved in a program not
only integrated with other activities in
EPA, but in close collaboration with
other agencies that regulate the
environment and with the health
research institutions of the Public
Health Service. By these standards, very
little has been accomplished. Why?
With the exception of the regulation of
PCBs, the agency was given overly broad
discretion to achieve these objectives.
The industry to be regulated was given
easily-abused responsibilities (which
they quickly abused) in testing,
reporting, and in the determination of
confidential business information.
The naive assumption was made that
any President would have sufficient
concern about the issue and Ihe power
JUNE 1985
to ensure interagency coordination and
to protect the public interest (as distinct
from the special interests of industry.
labor, consumer, and environmental
organizations).
Incredible, retrospectively ludicrous.
confidence was placed by government,
the environmental-labor coalitions, and
industry in a sub-set of our culture
called "science" to define the adjective
"toxic"—or at least develop a consensus
on its meaning—through the production
of objectively interpreted laboratory.
clinical, epidemiological, and ecological
data reflecting a broad range of effects.
New necromantic techniques
consistent with the shamanism of
current environmental assessment
produce increasingly controversial data
on an increasingly narrow set of effects
agent-by-agent. We know, for example,
that about 1,500 chemicals have
possible cardiovascular effects. The
development of methods to test for these
effects is hardly taking place and what
little we now know is not being applied.
Scientists respond to market demands.
just like the rest of us. but the market
for better determination of "toxicity" has
not been created.
In assessing the agency's performance
in implementing the Act, it is easy to
point to instances of lax, co-opted, or
shortsighted administration. A company
called CBI (Confidential Business
Information) seems to manufacture and
use most of the chemicals in our society.
The formula, effects, and identity of the
exposed populations have a common
name called BLANK. Expertise to
understand the work
environment—which the Act treats as a
concern equal to the ambient
environment—is so sparse and diffuse as
to effectively not exist.
Defenders of the agency can point to
an equal list of achievements, which
would have to include gathering some of
the best scientists and most dedicated
administrative staff found in either
government or the private sector Into
one agency to at least begin the very
hard work of regulation.
Criticism or defense of EPA's effort to
reduce risks from new chemicals that
excludes an examination of the
assumptions of the program is unlikely
to reveal the fundamental lesson of the
past: chemical innovation is a runaway
chain reaction that will be contained
only by a new program built on a new
set of assumptions.
13
-------
J. Ronald Condray
Director
Regulatory Management, Toxic
Substances
Monsanto Company
Monsanto Company, like some other
chemical firms, had in place a
program to assess the health and
environmental effects of new chemicals
well before the passage of the Toxic-
Substances Control Act (TSCA) in 1976.
But the premanufacture notification
(PMN) requirements of TSCA have
brought a new dimension to the
Monsanto program. EPA's PMN efforts
have improved Monsanto's internal
program, although not without creating
some problems for us.
A major strength of EPA's PMN
program has been the oversight it
provides lor new chemical development.
This oversight benefits manufacturers
by providing an independent audit of
any risks which might be posed by a
new substance. This lessens the
likelihood of a new substance presenting
an unreasonable risk to health or the
environment, and should result in a
reduction in liability claims.
The public also gains from the new
chemical review carried out by EPA. The
new chemical assessment process
administered by the professionals at EPA
requires a uniform, comprehensive
examination of all new chemicals
regardless of their source. EPA helps
assure the public of a new chemical's
safety by double-checking the quality of
risk assessments done by the
manufacturer and by requiring
additional safety tests or controls if
needed.
For all of its benefits, EPA's
administration of TSCA's new chemical
review provisions has not been
trouble-free from Monsanto's viewpoint.
Perhaps the most burdensome aspect of
EPA's work has been the time delays and
unnecessary costs associated with the
review of new compounds that pose
minimal risks. To date, the agency has
been overly cautious with materials such
as polymers, site-limited intermediates,
and other low-exposure materials.
This sometimes has caused
manufacturers to delay new chemical
introductions by six months or more
and has cost them certain customer
opportunities. Monsanto, in a few
instances, has actually abandoned the
development of new chemicals because
of costly health-effects testing
requirements not warranted by the risk
to health or environment of the new
products.
Both industry and EPA resources that
are expended to resolve EPA concerns in
these low-risk areas could be put to
better use in other more significant
elements of the PMN process, such as
follow-up of new chemicals after they
enter commerce. The current TSCA
orders and Significant New Use Rules
(SNUR) used for follow-up, while
effective, are burdensome to develop and
implement. Commitment of resources to
improve this phase of the PMN process
seems justified.
Monsanto has been working with EPA
to overcome problems of this sort and,
in general, we feel the strengths of EPA's
PMN program far outweigh its
weaknesses. We want to cooperate with
others interested in EPA's PMN program
to build upon its strengths. Pushing the
program to its limits through
overzealousness or battling over its
administration through the courts does
not serve any of us well.
Jacqueline M. Warren
Senior Staff Attorney
Natural Resources Defense Council
The purpose of premanufacture
notification (PMN) is to permit EPA
to make a reasoned evaluation of the
health and environmental effects of new
chemicals, before rather than long after
their entry into commerce. In order to
carry out this statutory responsibility.
EPA must necessarily have a certain
amount of toxicity and exposure data
about the new chemical.
As presently written, however, the
Toxic Substances Control Act does not
require PMN submitters to generate and
submit any toxicity data on the new
chemical or any information on exposure
beyond the workplace. Thus, the agency
has assumed the burden of assessing
the potential hazards of new chemicals
without specific data on the effects of
the new chemical being evaluated.
To accomplish this feat, the agency
has had to rely almost entirely on
information concerning
structure-activity relationships (SAR).
i.e., EPA assesses the potential risks of
new chemicals by studying available
information on similar chemicals. The
problem is compounded by the fact that
relatively little toxicity information is
available on the vast majority of existing
chemicals, as the National Academy of
Sciences pointed out in a 1984 report
entitled Toxici(y Testing.
In NRDC's view, the existing PMN
program is not accomplishing the
objective of accurately identifying
potentially hazardous new chemicals
before they enter commerce. Since the
program began in 1979. EPA has
received more than 4.500 PMN notices.
Agency figures show that consistently
EPA JOURNAL
-------
almost half of the notices have been
submitted with no data whatever on the
toxicity of the new chemical. This
statistic suggests that the PMN program
as currently implemented is not
encouraging the voluntary development
of premanufacture health and
environmental effects data, not even the
most basic acute toxicity data.
There is a similar dearth of
information on likely exposures to the
new chemical as it develops
commercially. Under the existing system,
many new chemicals enter commerce.
where they may greatly increase in
volume and exposure, although they
remain untested and uncharacterized for
adverse health and environmental
effects.
In an effort to follow changes in
exposure patterns of new chemicals
about which EPA has concerns, the
agency is attempting to track some of
them by issuing significant new use
rules. These are designed to apprise the
agency of major departures from the
conditions approved in the original PMN
submission. Only a few new chemicals
can be followed in this way. however,
and each rule involves a lengthy
administrative proceeding before it can
be put in effect. The agency could also
require follow-up reporting on new
chemicals on the Inventory by issuing
rules under Section 8(a), although this
approach does not permit the
Administrator to prevent the new
exposures from occurring while hazard
information is being generated. Only a
Section 5(e) order to prohibit or restrict
manufacture of a new chemical can
accomplish this basic goal of TSCA on a
case-by-case basis.
The legislative history of TSCA
strongly suggests that Congress
intended in Section 5 to put an end to
the "use first, test later" approach to
chemicals manufacture. Nevertheless,
eight years later, it is clear that EPA is
still allowing most new chemicals to
enter commerce with little or no toxicity
testing and very little information about
potential exposures. To remedy this
problem, the agency should use its
authority under Section 5(e) more
aggressively to require data for
suspicious new chemicals. At the same
time, Congress should amend TSCA to
authorize and require pre-market testing
of new chemicals so that chemical
producers selling in the United States
will have to do at least as much to
anticipate the adverse health and
environmental effects of their chemicals
as they are required to do before
entering the European market.
Dr. Thomas A. Burke
Director
Office of Science and Research
New Jersey Department of
Environmental Protection
From a state perspective, the
preventive approach of Section 5 of
the Toxic Substances Control Act is
perhaps the most important part of this
legislation. Properly implemented, this
section provides EPA with a broad range
of information on new chemicals prior to
their manufacture. This should enable
the agency to anticipate and prevent
environmental and public health
problems which may be associated with
the manufacture and use of new
substances.
The preventive approach of TSCA
should be a key component of our
federal environmental programs. Every
state in the nation is now burdened with
environmental problems resulting from
our past ignorance about toxic
substances. Whether the problem be
PCBs in our lakes and rivers, volatile
organics in our ground water, or
asbestos in our schools, toxic
substances have done irreversible
damage to our environment, have had
unmeasurable effects on public health.
and have presented enormous economic
burdens which are shared by all
segments of our society.
Since 1979, EPA has evaluated
thousands of new chemical substances,
and for over 90 percent of these
substances allowed manufacturing to
proceed without any regulatory controls.
These decisions have been based upon
toxicity evaluations and exposure
assessments. Toxicity evaluations have
been hindered by the limited amount of
data, particularly on chronic effects,
submitted with new chemical notices.
This has forced EPA to rely upon
structural activity relationships to assess
toxicity. This technique, though useful,
does not substitute for traditional
laboratory toxicity studies.
Implementation of TSCA could be
strengthened if EPA required more
detailed toxicity information from
manufacturers.
Exposure assessments are also an
important part of the EPA evaluation of
new chemicals. This is an area where
the state, with a wealth of experience in
environmental and human exposure
monitoring, could provide valuable
insights to EPA. Unfortunately, there is
no formal mechanism for states to
participate in this evaluation process.
Very little of the data supplied to EPA in
the premanufacture notification is
shared with states. This is due in large
part to the right of a company to claim
all or part of the information as
confidential. Thus, an Individual state
may be completely unaware of plans to
manufacture a new substance within its
borders. States cannot participate in the
EPA decision of whether the expected
exposures from manufacture and use
present an unreasonable risk to health
and the environment.
It is difficult to measure the impact of
EPA efforts to reduce risks from new
chemicals. Undoubtedly the regulatory1
controls imposed on many new
substances will have beneficial effects in
the states. However, these benefits could
be enhanced through a more active
federal-state partnership. The chemical
evaluation process should include states
so as to provide EPA with an Improved
measure of the impact of new chemical
production. States could also provide
valuable follow-up to the
premanufacturing notice, assuring that
new chemicals are manufactured and
used appropriately and safely. D
JUNE 1985
15
-------
Launching a New
Toxics Program
by Michael Stahl
On August 10, 1984, Congress
approved the final version of the
Asbestos School Hazard Abatement Act
(ASHAA). The major provision of the Act
called for establishment of a loan and
grant program to help schools pay for
asbestos abatement projects. Less than
10 months after ASHAA was passed,
EPA was scheduled to distribute S45
million in grants and loans to schools
and meet the deadline of June 6, 1985,
imposed by ASHAA.
The tight statutory deadlines, the
visibility and emotionally charged nature
of the asbestos-ln-schools issue, and the
problem of translating statutory
language and Congressional intent into
workable program policies and
procedures, all combined to make
implementation of the loan and grant
program a formidable challenge for EPA.
ASHAA provided procedural guidelines
for the loan and grant program. First.
EPA develops and distributes an
application form to all LEAs (Local
Education Agencies), i.e.. public school
districts, private school systems, and
individual private schools. Next, LEAs
forward these applications to their state
Governors (or the Governor's designee)
so the applications can be ranked by the
state. Once ranked, the states forward
all applications and rankings to EPA.
Then, EPA reviews all applications to
assess the severity of the asbestos
problem within a given school and the
financial need of the LEA.
The agency was faced with two very
difficult questions in connection with its
new responsibilities under ASHAA: How
can EPA identify and resolve the literally
hundreds of policy and procedural issues
associated with the implementation of
the loan and grant program? And how
can EPA best utilize Its scientific,
technical, and administrative resources
to meet the June 6 deadline for
distribution of funds?
i.s ('h(<;/ iif (hf -Sch*»/
ScclJon of the /Vs/xvsfos Arft'on
in Kf'A'.s <)//'/(•(• ()/ /Vsu'a'c/rs unrl To.vir
•• •
EPA's First Steps
Responsibility for administering the
ASHAA loan and grant program was
assigned to a newly created Asbestos
Action Program (AAP) headed by Susan
Vogt. The AAP is a staff unit of the
Office of Pesticides and Toxic
Substances.
The agency's first task was to develop
an application which would elicit all the
information EPA might conceivably need
to evaluate an applicant's asbestos
hazard and financial need. Drawing on
the experience of EPA's asbestos experts
and on the knowledge of education
association officials and Department of
Education personnel, a work group
headed by Cindy Stroup of the Office of
Toxic Substances (OTS) developed an
application form. In mid-December, EPA
mailed applications and asbestos
guidance documents to 33,000 LEAs
across the nation. This was followed in
January by a loan and grant program
policy statement which explained how
EPA would administer the loan and
grant program.
The next task was to develop a
uniform method for evaluating and
ranking asbestos hazards so that states
could rank the hazards in their schools
and EPA could produce a national
ranking. After considerable discussion
and review among EPA's asbestos
specialists, David Mayer of AAP and Joe
Breen of OTS developed a method which
sorted asbestos hazards into six
categories according to the degree of
damage to the asbestos-containing
material, whether the material was
exposed, and whether the material was
located in an air plenum (a space
between a roof deck and a false or
suspended ceiling). These characteristics
were judged to be the most important in
categorizing asbestos hazards and
evaluating their severity. The method
utilized a limited set of data from the
form, and proved relatively simple to
use.
Developing a financial need formula
was the next task in implementing the
program. Discussion with
representatives of public and private
school associations led to the conclusion
that there was no single school financial
indicator which EPA could use to assess
the resources available to public and
private schools. Sharon Hagan of the
Economics and Technology Division of
OTS developed a formula which
measures the cost of an LEA's
abatement projects against the amount
of per capita income for a public school
district or the amount of operating
budget per pupil of a private school. The
fewer resources a private school or
public school district possessed, the
more money it would receive.
Assisting the States
Given the difficult time constraints of
the program, EPA recognized that
assistance to states in fulfilling their
ASHAA responsibilities was going to be
crucial to the success of the program.
EPA recommended that states impose a
deadline of February 15. 1985 for LEAs
to submit their applications to state
ASHAA designees. This would give states
one month—until March 15,
1985—to review and rank the
applications and submit them to EPA.
To assist the states during this period,
EPA provided temporary assistance
through a contractor: a data entry clerk,
a personal computer, and a hazard
ranking software package to any state
that needed these resources to complete
application processing. Forty states took
advantage of this assistance, and all
participating states submitted their
applications to EPA by the deadline.
Reviewing the Applications
EPA received 1,100 applications from
LEAs around the country. These
applications contained funding requests
for 8,300 abatement projects in 4,800
individual schools.
Bryon Griffith and Steve Young of
EPA's Office of Information Resources
16
EPA JOURNAL
-------
Children studij beneath a schoolroom
ceiling insulated iriih triable
spraijed-on
D
The reports filed by the inspectors
were used in the technical review of each
individual project. This phase allowed a
detailed review of the hazard, financial
need, and grants regulations aspects of
each abatement project on the
preliminary award list. The principal
architect of this review was Larry
Culleen. an attorney on the staff of the
AAP. During technical review, pictures of
all project sites were reviewed, and, if
necessary, the inspector or the LEA was
called for further information. Kathy
Chovan and Karen Hoffman led the
effort to make these personal contacts
with the regions or LEA. The technical
review team analyzed over 900 projects
during the first half of May. Final
approvals or disapprovals for each of
these projects resulted from this review.
After final approvals totaled $45
million, the final award list was handed
to Tom Hadd of the Grants
Administration Division. About 500
award offers were processed over a
10-day period by Division personnel, an
extremely quick turn-around for such a
high volume of awards. A policy for
offering and monitoring loans was also
developed, the first procedures EPA has
ever put together in this area.
Meeting the Deadline
Management managed the formidable
task of completing data entry for all
applications in 10 days, developing the
computer programs necessary for
analysis of the application data, and
setting up systems to maintain and
retrieve LEA records in an orderly
fashion. This work was indispensable to
the successful completion of the
program.
It was necessary to mail requests back
to many LEAs for clarifications and
corrections of certain key data elements.
Hundreds of correction requests were
mailed out and returned between March
25 and April 3.
The next task was to develop a
preliminary award list which ranked all
projects in each hazard category
according to the number of exposure
hours. Each project on the list also had
an award amount assigned to it based
on the financial need of the LEA as
assessed by the program's financial need
formula.
A "working list" of awardees was now
in hand, and we requested that on-sile
inspections of potential awardees be
conducted by regional personnel. EPA's
Regional Asbestos Coordinators, along
with regional staff hired under an
existing grant with the American
Association of Retired Persons,
conducted more than 700 pre-award site
inspections.
As the Journal went to press. EPA was
scheduled to notify all applicants of
award decisions and announce the
results of the grant and loan program ii
accordance with the June 6 deadline.
Through the talent and cooperation of
state officials, school district personnel
and EPA headquarters and regional
staff, a very complex task was made
manageable. Although everyone
associated with the program can think
of ways to simplify or improve the
process, the ASHAA loan and grant
program was a significant
achievement. D
JUNE 1985
17
-------
Spelling Out
Directions for EPA
by Lee M. Thomas
In linnrnsville. Tex., in April,
/•;P/\ ijllicial Edicin Johnson, left.
* to the voice ill public opinion.
More tlirui :l.000 people attended (his
public hearing on ocean incineration.
rtmunifiy involvement
in KI'A proarcuns is a hiyh
priority oj Lee Thomas.
EPA Administrator Lee M. Thomas
recently addressed the National
Press Club in Washington. D. C..
spelling out the priorities oj the
agency. Here are excerptsfrom. his
speech:
George Bernard Shaw once observed
that there were two kinds of work in
the world. The first consisted of moving
objects from place to place on the
surface of the earth and the second
consisted of telling other people to do so.
While environmental protection consists
largely of the first type—moving stuff
from a place where it may do harm to a
place where it won't—EPA's role is to
define when, where, and how the move
should take place.
Doing this sort of work right requires
an enormous amount of careful thought.
"Careful" because the laws of nature,
which rule that work, are unforgiving,
and not subject to amendment on
Capitol Hill. Doing it right also requires
a minimum amount of stability.
continuity, and consistency. It can't be
done in a firehouse atmosphere. If it is
done "carefully" and "right", the benefits
for us and our children can be immense.
For that reason, we must dedicate the
next four years to obtaining measurable
environmental results. We must improve
the management of our programs and
increase our understanding of what the
federal environmental protection
enterprise can really accomplish.
Beyond that, we must begin to pursue
a neglected facet of EPA's original
charter. That is the integration of all
environmental programs into a managed
system, capable of focusing federal
authority on the reduction of
environmental impacts wherever they
are found, in the most effective and
efficient way.
This is a pragmatic approach to a set
of issues that have often been dominated
by symbolic and political concerns, but I
think its time has come. EPA has been
given—perhaps not in the most
thoughtful way possible—an almost
frightening armory of powers. It can
affect almost every aspect of American
life—what we eat and drink and how
much we pay for it, what we drive, what
kind of gas we use. the kinds ot jobs we
can work at. From the laundry room to
the board room. EPA is there.
We must make sure that our efforts
over the next four years are concentrated
on the reduction of important
environmental risks, at places and in
situations where the federal power is
essential. It is not efficiency alone that
demands this discipline.
Nothing erodes the public's tolerance
of a regulatory agency more than the
imposition of burdens that appear to
have only petty results in terms of some
substantive public benefit. At the same
time, nothing erodes the public's faith in
a regulatory agency more than the
appearance that it is not. for whatever
reason, acting aggressively in the public
interest.
My perception is that we have at this
point achieved a reasonable balance
between these two poles. I don't want to
see the pendulum start swinging again,
because if it does, the agency will once
again be distracted from its important
goals by controversy and political
friction.
What, then, are some of the important
problems? Where do we think our efforts
must be concentrated over the next four
years to achieve the maximum
environmental improvement? Such
efforts must involve taking fresh looks at
the problems of the older programs that
form the backbone of EPA. They also
include ensuring that some of the newer
ones are making progress in real
environmental terms.
Sewage treatment is important. We
have spent nearly $40 billion on this
program. The good news is that a
steadily increasing percentage of
Americans are being served by adequate
treatment; 57 million people have been
added to the system since 1972.
However, 13 percent of [he 3,600
largest systems do not comply with their
permits. Others are overloaded or
subject to frequent breakdowns. Many
communities have chosen not to, or are
not able to, operate and maintain their
plants properly.
Our efforts in this area will be focused
on stiffening our enforcement against
municipal facilities, and providing
technical advice to the states on
18
EPA JOURNAL
-------
operation and maintenance problems.
Additionally, we must do this while
exploring ways for converting the federal
construction grants program to
something states and localities can
manage on their own. It was never
intended to be a permanent federal
program.
Controlling ozone and the other major
air pollutants is another important area.
While I appreciate the concern about
more exotic toxic air pollutants, we
should not forget that controlling the
criteria pollutants remains the best way
of preventing public health and property
damage from the effects of air pollution.
There are still 54 urban areas that
clearly do not meet ozone standards and
72 areas that do not meet carbon
monoxide standards. We have until 1987
to bring all of them into compliance.
Also, we are starting to see that our
basic strategy for dealing with these
pollutants, a strategy that assumes that
the major environmental effects are in
the airshed where they are released, may
be mistaken in some important cases.
We may have to start taking a regional
view when establishing pollutant
limitations.
It is now also becoming apparent that
atmospheric chemistry is far more
complicated than we imagined only a few
years ago. Many pollutants interact;
changing the level of one may decrease
or increase the level of another. Part of
the difficulty we have faced in deciding
on the best way to deal with the acid
rain issue is only the most familiar of
these problems. There are others.
Non-point source water
pollution—another important area. If we
don't do something about this kind of
water pollution, which comes from
drainage off farms and urban areas,
then on many water bodies we will never
reach the ambitious goals of the Clean
Water Act. It won't matter how hard we
clamp down on point sources such as
industrial outilows, the water will stay
dirty.
What we do about non-point pollution
will have an enormous impact on the
nation's wetlands—and wetlands are
important. They are the most productive
areas for a host of environmental values.
In the past two centuries we have
converted about half of America's
original body of wetlands in the lower 48
states to other uses.
We have the problem whose apparent
importance has eclipsed that of all
others in recent years—what to do about
toxic substances and all that hazardous
waste.
I think we recognize that nothing is
more critical than continuing and
completing our review of all existing
chemical and pesticide products. We
must ensure that our most stringent
health-based standards are complied
with. At the same time we cannot
neglect the thorough review of new
products proposed for the market.
As far as hazardous waste is
concerned, I am beginning to sense a
change in attitude on the Superfund
side of this issue reflected in the kinds
of questions we have been getting from
Congress. I believe this is the result of
our increased understanding of the
dimensions and complexity of the
problem.
In its recent report, the Office of
Technology Assessment (OTA) came to
an important realization, one that we in
EPA had reached through first-hand
experience. It is that our clean up
program is operating on the cutting edge
of pollution control technology. Each site
JUNE 1985
19
-------
presents a complex and unique problem,
whose solution strains current analytic
tools.
Although we do not want to slow the
momentum of the Superfund program,
we must realize that we run the risk of
serious errors if we try to force technical
solutions at sites where they are really
not appropriate. OTA recognized that it
makes little economic or environmental
sense to undertake costly long-term
cleanup projects until we are sure that
we have the technology to do it right.
Of course, we must continue to locate
immediate environmental and public
health threats and deal with them
effectively, which is what we have been
concentrating on. Our proposed
extension of Superfund will enable us to
continue with these important actions.
I believe we need to pay a lot more
attention to community relations in
those places most affected by hazardous
wastes, in the belief that local people can
help us make intelligent risk
management decisions when we share
the available information with them. For
that matter, citizens can contribute to
making better decisions in all
environmental areas. 1 Intend to stress
community involvement in each of our
line programs.
I have been talking about
concentrating on the important
problems, but just as important is the
manner in which we exercise this
concentration. It is by now well known
that pollution can move among the
environmental media—from air to water,
from surface water to ground water,
from water to soil, and so on.
But EPA is composed of individual
programs, each carrying out a particular
statutory mandate. These are typically
focused on individual media. It is
understandable that someone under the
gun for Instituting water cleanup may
not have paid the closest attention to the
effect on the air resulting from that
cleanup. But someone should have.
From now on, someone will.
I mentioned the importance of
improving sewage plant performance. I
will add that the settling ponds and
lagoons used in many of these plants
are, in a number of industrial areas, a
significant source of toxic air pollutants.
The toxics come from industrial plants
that discharge into the sewer system.
We will be able to control much of this
problem through pre-treatment—the
removal of the toxic material at the
source. But if you have followed my
argument you can see that this is yet
another inter-media transfer—from
water into hazardous "solid" waste,
which will have to be disposed of in
some way.
This circle game has to stop. It is
expensive. At best it is misleading—we
think we are solving a problem and we
aren't. At worst, it is perverse—it may
increase rather than reduce pollution
risks. It seems to me that the solution to
this problem is the consistent
application across all agency programs of
what we have been calling risk
management.
Reducing risk—to human health and
environmental values—is after all the
reason we remove pollutants from the
environment. It is the currency of our
business. By closely watching the
movement of pollutants that results from
regulatory options and calculating the
attendant risks for each, we can assure
the public that our actions are indeed
connected with a measurable,
permanent good.
In summary, then, I see a four-point
environmental management plan
emerging over the next four years. First,
we will make sure that our priorities are
those that can have important
environmental results. We will take steps
to ensure that measuring those results
becomes a centra] part of agency
management. Over the next few years 1
want to complement and in some cases
replace the largely administrative
measures in our internal accountability
system with indicators of environmental
progress for each program.
Second, we will continue the strong
movement envisioned in our
environmental statutes to decentralize
our programs and delegate additional
responsibility to regions and states.
Environmental protection is too large a
dog to be wagged by a tail clutched in
Washington. We intend to do everything
we can to increase the flexibility with
which states and localities may
implement federal standards. We will
also strengthen our technical support
and oversight role. We must continue to
change policies and long-standing
practices that impede this movement.
In this regard, we will continue our
efforts to collect information on risk in
particular areas subject to unusual
environmental stress. Such information
gives us the ability to work with states
and localities to tailor environmental
solutions to the varying needs of
different geographical areas.
Third, we will increase the emphasis
we give to community involvement and
public education. At present, we require
a detailed community relations plan for
all Superfund sites. We have
recommended that this be embodied in
law. I have also asked that all the line
programs develop community relations
and public outreach strategies. If what
we are doing makes sense, we ought to
be able to communicate that to the grass
roots better than we have in the past.
We must also establish forums that
consistently provide input to us from the
public as we make decisions which affect
people's lives.
Finally, we must plan control solutions
with a multimedia perspective. We have
to reduce risk and not merely transfer it.
Building an integrated management
structure at EPA will not be easy. But we
have some of the elements in place, and
we have the will to do it. We must focus
our resources on the most important
problems, and fix them so that they stay
fixed. D
20
EPA JOURNAL
-------
EPA Diary
On-Scene
Coordinators
Don't Eat
Quiche
by Susan Tejada
(Another special report on how some
EPA employees spend their working
days.)
Some people call them "cowboys"
because of their independence and
machismo.
Others call them "little corporals"
because of their Napoleonic flair for
commanding the troops in a crisis.
But in the more prosaic terms of the
bureaucracy, they are On-Scene
Coordinators, or OSCs.
Under the Superfund program,
On-Scene Coordinators from EPA take
charge of hazardous waste emergencies
on land and in non-tidal inland waters.
(The U.S. Coast Guard handles oil and
hazardous waste spills in coastal and
inland tidal waters, and the Army Corps
of Engineers handles longer-term
cleanups.) About 70 OSCs are stationed
in EPA regional offices across the
country.
For On-Scene Coordinators, life is an
endless string of midnight dumps.
highway accidents that release
hazardous cargo, pesticide fires,
chemical explosions, and polluted lakes,
lagoons, and wells. OSCs work
accompanied by a persistent chorus of
vocal citizens, aggressive reporters, and
never-ending paperwork. The "on-scene"
in their title is accurate. They have to
spend many of their days in mobile
command posts, many of their nights in
tacky motels.
George Moein, 48. came to the United
States from Iran 30 years ago as an
exchange student in engineering and
earth sciences. After graduate studies
and work for the U.S. Navy in
oceanography, Moein joined EPA in
1970. He spent three years working at a
desk in Washington, D.C., writing
regulations for cleaning up oil spills. But
he had an itch to work on the "front
lines," as he puts it, so in 1973 he
joined the staff of the EPA regional office
(Tejada is Associate Editor of KPA
Journal.)
t
George Moein on (in
response.
I
in Atlanta as an OSC. He became Chief
of the region's Emergency Response and
Control Section in 1982. For the past
year and a half, his region has led the
country in total number of emergency
responses undertaken and completed.
This article describes one of George
Moein's emergency responses.
January 30, 1985, 11:00 a.m.
In the office catching up on some
paperwork, George Moein receives an
urgent call from his boss Al Smith, chief
of the region's Emergency and Remedial
Response Branch. Congressman Bill
Hendon of North Carolina has just
informed the regional administrator of
an immediate need to remove two
chemical drums discovered in his
district. According to labels on the
drums, they contain BZ/CS, a chemical
warfare agent manufactured for the
Army during the Vietnam war for the
purpose, as Moein later puts it, of
"immobilizing enemy soldiers and
making them go crazy."
BZ/CS, which was never actually used
during the war, is an extremely potent
combination of hallucinatory drug and
tear gas. A mere speck of the BZ. an
odorless white powder, can induce
severe disorientation for up to seven
days. A release from the drums could
spell disaster for the several hundred
workers at the North Carolina chemical
plant where the drums were found and
for the general public.
In OSC jargon, another "screaming
emergency" is under way.
Moein immediately sets out to learn
what he can about the two drums. They
are sitting above ground in a wooded
area at a site where various companies
have been manufacturing chemicals for
the U.S. Army since World War II. Many
chemicals have been stored or buried
throughout the 1,000-acre facility; and
the two drums in question represent.
says Moein. "the tip of the iceberg in
terms of what is there." The site is
already on the Superfund National
Priority List for remedial action.
Exactly how dangerous is the BZ/CS?
Moein talks to a former employee who
worked for the company that
manufactured the now-discontinued
drug. After being accidentally exposed to
a minute dose of the substance, the
employee had spent five days in a
hallucinatory nightmare, wandering
aimlessly through the woods until he
was found.
Moein calls the company to begin
discussions about who will dispose of
the drums and who will pay for the
operation. The upshot of the
conversation is the scheduling of a
meeting between Moein and company
officials for 9:00 the next morning.
1:30 p.m.
In the midst of a furious ice storm.
windshield wipers slapping the sleet off
the glass, Moein leaves Atlanta and
starts the four-hour drive to the
company site in North Carolina.
"Emergencies." he notes wryly, "either
happen in awful weather or outside
normal working hours."
2:30 p.m.
In Commerce. Ga., Moein pulls off the
road to make some phone calls. No less
accurate than the "on-scene" part of an
OSC's title is the "coordinator" part.
With a lot of the coordinating done by
phone, it's hardly surprising that, in a
school assignment, one OSC's young
daughter once described her father as a
man "with glasses, curly hair, and a
phone in his ear."
Moein dials Andrew Anderson, a
civilian expert on BZ for the Army, to
discuss procedures for neutralizing the
drug. The next call—back to the regional
official in charge of EPA's remedial
investigation at the site—confirms
Anderson's technical information.
7:00 p.m.
Delayed for more than an hour by the
storm, Moein arrives at the motel where
he will be staying near the company site
in North Carolina. A stack of messages
waits for him and, for the next few
hours, Moein returns "a whole bunch of
phone calls" from company and regional
officials.
JUNE 1985
-------
January 31, 1985, 8:00 a.m.
Moein notifies the EPA emergency
response contractor to put workers
on standby for neutralizing the contents
of the drums. Then he checks in with
his office. "It's an unwritten policy in
Region 4," Moein explains, "to cal! the
office twice a day when you're in the
field. You let management know what's
going on, and get their feedback. You
also need to let them know how well
you're holding up in some rather bad
situations."
9:00 a.m.
Moein sets out for his meeting with
company officials. What he finds when
he arrives gives him a jolt: an army of
reporters representing newspapers and
TV stations from as far as 200 miles
away. "They were standing outside the
company gatehouse in the sleeting rain,"
Moein recalls. "They weren't allowed
inside until later. But they were
persistent. They stayed all day."
Though Moein did not expect to find
so many reporters hot on the story, he
isn't surprised either. "An OSC becomes
seasoned to this," he explains. "In fact,"
he continues, "sometimes you worry if
the reporters are not there. Because if
you're frank and aboveboard with them,
in many cases they can help a lot. If
they're accurate, and don't overplay a
story, they can inform citizens of the
facts they need to know without creating
panic."
9:20 a.m.
The scheduled meeting begins.
Representing EPA are Moein and Freda
Griffis, a contractor with the region's
technical assistance team. Representing
the company are its president,
environmental coordinator, and several
technical people.
The company agrees to the fact that
the drums do indeed contain
BZ/CS—not pure BZ/CS. but debris
contaminated with the substance. EPA
wants the company to take responsibility
for disposal of the drums. However,
since the substance was manufactured
by another firm, long before the present
firm occupied the site, the company feels
the Army should take responsibility for
disposal.
A conference call is put through to
Anderson, the Army's point man for the
site, and negotiations begin. The Army
refuses to accept the fact that the drums
contain BZ/CS unless the contents are
confirmed by lab analysis. It refuses to
accept liability for moving the drums to
its incineration facility in Pine Bluff,
Ark. And it says that the neutralization
procedures discussed earlier will be
99.99 percent effective.
22
At this point, a company official
produces an official Army document
stating that the neutralization
procedures are not effective. This, says
Moein in a classic example of
understatement, "caused a lot of
confusion."
10:00 a.m.
Moein calls Al Smith, who tells him that
the company lawyer has relayed a
message to the regional administrator:
get Moein out of there until the regular
remedial process is completed. The
average length of a remedial cleanup,
from planning to construction, is about
four years.
Such interference is a common
delaying tactic, Moein contends. "It just
doesn't work in this region because our
regional administrators trust the
technical judgment of the OSCs."
10:30 a.m.
Moein finds a lab in North Carolina that
will accept samples of the drum contents
and run tests on a priority basis. He
puts the lab on standby.
10:53 a.m.
With Moein present, company officials
call Anderson to continue negotiations.
Because information on BZ/CS is
classified, a literature search will turn
up little useful material. But the Army
now provides additional information on
exposure levels, and it is not reassuring.
A release of minute doses of BZ/CS
would be enough to warrant an Army
designation of "alarm level."
Neutralization procedures are
discussed. The earlier discrepancy
between Anderson's advice and the Army
study is resolved: the study had been
based on neutralization of pure BZ/CS,
while the advice was based on
neutralization of BZ/CS-contaminated
material, the situation that exists on
site.
1:12 p.m.
Although disposal plans have not been
finalized, Moein begins emergency
planning arrangements in case of an
accident. He notifies local hospitals and
rescue squads about the situation. He
gives physicians an Army telephone
number to call for information about the
drug's effects and antidotes. And he
advises on the best treatment for
someone exposed to BZ/CS: keep the
individual locked in a padded cell to
prevent self-destruction until the drug
wears off. The local medical community,
says Moein, is not exactly thrilled to hear
all this.
Such planning is routine. "We always
do it in these kinds of cases," says
Moein. "If someone gets hurt, the
hospitals have to know how to treat
him."
Moein is particularly anxious about
accidents at this site because of the
continuing bad weather. "1 don't worry
about explosions, fire, all hell breaking
loose—that stuff we can control," he
says. "It's the simple little freak
accidents that concern me. It had been
raining and sleeting for days. The
ground was slippery. Someone could
easily fall and spill the contents of the
drums."
2:00 p.m.
Having eaten nothing for the past 30
hours, Moein decides it might not be
such a bad idea to grab a bite. As he and
Griffis drive to a restaurant, he notices a
Startling sight in his rear view mirror:
eight cars filled with reporters are on his
tail.
"As I munched on a sandwich, they
bombarded me with questions," Moein
recalls. "I told them no decisions had yet
been made on who was responsible, but
I would give them a decision by the end
of the afternoon, because if no one else
would take responsibility, EPA would."
3:00 p.m.
Back at the company, Moein finds
another stack of messages. The company
had made a conference room available to
him, and it is from here that Moein
returns the calls. When no phone lines
are available, he runs outside to the
phone in his van, where the reporters,
huddled in the rain, follow him in an
attempt to eavesdrop.
The phone calls do not bring good
news. The lab that had earlier agreed to
test drum samples now refuses to do so.
The lab's chemists have threatened to
stage a walkout rather than handle
BZ/CS.
4:35 p.m.
The company president reaches a
decision. The next morning, when it is
light, he will have the contents of the
drums neutralized and removed to a
disposal facility.
"That was the first good thing I'd
heard all day," recalls Moein.
5:00 p.m.
More good news comes from the EPA
contractor in Atlanta, who informs
Moein that he has located an approved
landfill in Pinewood, S.C., that will
accept the neutralized contents of the
drums for disposal.
February 1, 1985, 7:00 a.m.
The contractor's site crew, having
arrived at midnight, takes samples of
the drum contents, although a lab that
will accept the samples has not yet been
found.
EPA JOURNAL
-------
8:00 a.m.
In a reversal of the president's decision
of the previous day, the company
attorney informs Moein that the
company can accept no responsibility for
the presence of the drums and can take
no action to neutralize or remove their
contents at this time.
In that case, Moein states, he will
undertake an emergency response under
Superfund. The attorney says he is not
very happy about that. "Neither." says
Moein, "am I."
1:15 p.m.
As sleeting rain continues to fall.
members of the EPA contractor's site
crew use a sodium hydroxide-based
solution and chemical hydrolysis to
neutralize the contents of the two
drums. They stay in radio contact with
Moein, who has established a command
post in a nearby shack.
1:50 p.m.
Moein holds a press conference in an
open field to inform the shivering
reporters that the neutralization process
Is underway.
2:10 p.m.
Region 4 Director of Public Affairs Frank
Redmond informs Moein that the State
of South Carolina is having second
thoughts about allowing the neutralized
drum contents to be disposed of in
Pinewood. The civil defense director in
Pinewood has threatened to shut down
the landfill unless he receives assurances
that all traces of BZ/CS in the drums
have been neutralized.
3:45 p.m.
The site crew completes the
neutralization process without incident
and returns to the command post. The
drums are then packed into larger
recovery drums supplied by the
company. The recovery drums are sealed
to secure them against tampering and
protect them from the weather.
For the next two hours, Moein tackles
the paperwork required to document the
events of the past two days, and wrestles
with the Catch-22 dilemma the response
now presents: Pinewood will accept the
drums only after their contents have
been certified as BZ/CS-free by a lab, but
no lab will touch the stuff.
7:30 p.m.
In weather just as crummy as when he
started out, Moein begins the drive back
home to Atlanta.
Over the next four days, Moein
continues the search for a lab that will
accept the drum samples for testing,
finally locating one in Birmingham, Ala.
He uses all his persuasive powers to
convince the Army to provide the lab
with classified material on BZ/CS so it
can perform the analysis. Test results
show that no trace of BZ/CS remains in
the drums. That means that the
neutralization has been successful, and
the Pinewood landfill will accept the
drums for disposal.
February 1. 1:15 p.m.:
Moon-suited workers in \orih Carolina
rtvnorc BZ CS-contaniinated waste
Jrom drums. Other workers, far right,
stand by. ready to spray the ivaste
icith neutralizing solution.
On February 5, 1985. the drums.
followed by a convoy of reporters, are
shipped to Pinewood. George Moein
holds a news conference to announce
completion of the emergency response.
The life of an On-Scene Coordinator,
according to Moein, takes a heavy toll.
OSCs work on a rotation system. Being
on call day or night, weekday or
weekend, their lives lack a normal
routine. "You can't take evening
courses," says Moein, "or watch your
kids' soccer games, or go to church on
Sunday. A couple of times, my beeper
went off when I was receiving
communion. After that I decided to
forget the beeper and just stay close to
the phone."
OSCs operate under enormous
pressure. Part of that pressure is the
power they wield: power to authorize
expenditures of up to SI million with
the stroke of a pen, power to control a
diverse team of scientists, laborers, and
company presidents. To handle the
pressure without burning out, an OSC,
according to Moein, needs three
characteristics: the strong desire to
accomplish something, the ability to
manage incredibly complex and
dangerous operations, and the gift of
serenity." An OSC," he says, "has to stay
cool while everyone else around him is
shouting. As for me," he continues, "1
stay calm. Then I go back to the motel
and start kicking the walls. There are a
lot of gray hairs in this program."
Why do OSCs take it? "EPA's mission,"
Moein explains, "is to protect public
health and the environment. OSCs work
at the grass roots, doing exactly that. We
are the firefighters of this agency."
Moein doesn't see the need for OSCs
diminishing any time in the near future.
"In Region 4," he says, "there are about
1,500 to 2,000 incidents involving oil
and hazardous substances a year.
Seventy-five to 80 percent of the
incidents are spills caused by
transportation-related accidents. To
think that these accidents aren't going
to happen is Utopian." (H
JUNE 1985
23
-------
Protecting the Public from
Toxic Air Pollutants
by David R. Patrick
(At press lime. EPA plans regarding an
air toxics strategy were under way.
Announcements regarding thai strategy
are possible at any time.)
'"Proxies, dioxin. methyl isocyanate,
JL formaldehyde, asbestos: these and
similar alarming terms are frequently
front page news. We ask ourselves: "Will
I or my family get cancer from the air we
breathe? Should I move away from the
industrial operation nearby?"
How much of this alarm is
well-founded is a very difficult question
to answer. Certainly, Bhopal was real, as
real a tragedy as can occur. But, was it a
freakish accident that is unlikely to
happen again?
More and more is being learned about
the complex issues that make up the
toxic air pollutant problem, and EPA is
building a strategy for better
management of this problem in the
future.
The Air Toxics Problem
Almost any human activity, from making
steel to driving automobiles, releases
pollutants into the air. The pollutants
dissipate. Some break down under
action of sunlight while others react to
form new substances. Still others
remain unchanged and build up in the
air or soil. Because the atmosphere is
vast, humans normally are exposed to
relatively low concentrations of each of
these substances, usually concentrations
measured in parts per billion.
While these numbers may seem
vanishingly small, some of these toxic
substances can adversely affect humans
at those low levels. Others may
l!'
-------
Localized problems - Another portion of
the air toxics problem arises from
sources of pollutants that, while not
national, are big enough to possibly
affect people in the limited areas where
such sources are located. In these
Instances, local regulations likely can be
implemented more quickly and cheaply
than federal regulations, and can be
better tailored to the specific situation of
the source and the surrounding
population.
A pilot state control program is
currently underway on the chemical
acrylonitrile. This chemical, which
causes cancer in animals, is made and
used at 26 industrial facilities in the
United States but, because of various
local regulations and other factors, only
a fraction of these facilities result in
relatively high risks to humans. While
state and local governments will handle
primary regulation of these situations,
EPA will play a large role by providing
technical, administrative, and resource
assistance.
Multiple source problems - The final
portion of the air toxics problem deals
with areas of the country impacted by
several sources of toxic air pollutants.
These geographic situations usually
occur in industrialized cities or
industrial complexes. At present, EPA is
furthest from understanding and dealing
with this part of the air toxics problem.
Current activities include developing
more comprehensive inventories of
sources, pollutants, and locations.
The Future
Although many different issues remain
to be resolved, it is clear to EPA that a
fundamental change in the air toxics
program in the future is necessary to
better protect the public health. The
Section 112 program is moving and
being expanded: a state/local pilot
program is underway to verify the
usefulness of this type of response; and
data gathering has begun to better
define the potential for, and risks
associated with, multiple source
problems. EPA also is working with
Congress to enact the most useful
legislation to deal with air toxics. A more
effective air toxics control program is
definitely being constructed. D
.A scenic I'ii'ir ojlluailionse Roif in Philadelphia.. The cii\\ is
one of three urban areas in lite ronmny f/iur tjanicipaied in
art KI'A study to identil'ij palhti'dtjs o/'nir toxics into ihe
environment.
JUNE 1985
25
-------
Environmental Audits:
A New Enforcement Tool
-
U'a.sfr (/cc/) in n ir/irul Held, l
employees »t Pennsylvania Pouv
I.K/nf ('niDjiiuni <-t>n
-------
comprehensive environmental assurance
program. Yet, the company's own report
on the disaster at its subsidiary in
Bhopal admitted that key elements of
that program were not followed. When
asked about the failure of their program
to safeguard against such a disaster,
Warren Anderson, Chairman of Union
Carbide's Board of Directors, stated:
"Safety is the responsibility of people
who operate in our plants. It's a local
issue." That is a potentially dangerous
delegation of responsibility.
A number of recent events vividly
demonstrate that high-level corporate
oversight of environmental safeguards is
needed—not only because of possible
EPA or state enforcement action, but
also because the very future of the
company may be severely affected by
failure to observe environmental
diligence.
Consider the following cases:
Love Canal, the infamous hazardous
waste landfill, has generated claims
running into hundreds of millions of
dollars for cleanup, property damage.
and persona] injury against its former
owner, Hooker Chemical Co., and its
successor, Occidental Chemical Co.
The claims of thousands of asbestos
workers and their families for disability
or death benefits due to exposure to that
substance have driven Johns-Manville
Corp. and other asbestos companies to
seek the protection of bankruptcy
courts.
The release of a highly toxic cloud of
methyl isocyanate from the Union
Carbide plant in Bhopal, India.
reportedly claimed some 2.000 lives and
caused 200,000 injuries, resulting in
damage claims running into the billions
of dollars.
There are many other, less spectacular
cases in which releases of chemicals into
the environment have caused and
continue to cause businesses to incur
major costs. EPA's Superfund program
alone envisions expenditures by the
private sector of several billion dollars.
As science continues to develop methods
of linking chemical exposure to illness
and disease, "toxic tort" suits will
undoubtedly increase. The potential for
corporate exposure to liability for harm
to the environment and health grows
daily.
In many cases, the financial health of
some of the country's largest
corporations has been or may be severely
affected. The threat of financial ruin
through an environmental disaster is
just as real as failure due to faulty
business transactions. This threat will
undoubtedly do more to get the
attention of top corporate management
than any EPA or state enforcement
action. The incident at Bhopal—which is
to the chemical manufacturing industry
what Love Canal has been to hazardous
waste disposal—has already caused some
companies to reassess their
environmental and safety programs.
The need for such reassessments
throughout industry may be too
important to rely on the voluntary action
of individual corporate management.
More environmental calamities should
not be required to convince corporate
management to examine its
environmental policies and procedures.
There is a growing school of thought
within EPA that the agency should do
more to encourage a higher level of
corporate consciousness toward
compliance with environmental laws.
This encouragement could be supplied
in the context of EPA enforcement
actions against a company for violations
at one or more of its facilities. As part of
those actions, the company might be
required to assess its environmental
policies, procedures, organizational
structure, operations, and
management—or lack of them—to
determine whether they are designed
and implemented to ensure maximum
compliance. This is called an
environmental audit.
This approach would have effects far
beyond those produced by the traditional
enforcement action. Any improvements
in the company's environmental
operations resulting from the
assessment would apply throughout the
entire company, raising the level of
environmental compliance at all
facilities. This would also be a highly
efficient and effective use of EPA's
enforcement resources, a fact important
to EPA at this time of expanding
enforcement workload.
An "environmental audit" could be
similar to an audit of a company's
financial records and procedures,
performed by an outside consultant
or—less desirably—by a company's
internal environmental audit team. For a
number of years, EPA has been
interested in the concept of
environmental auditing as a method to
promote voluntary compliance with
environmental laws, and we encourage
the regulated community to conduct
these audits as a matter of good
business practice. However, the idea of
using an enforcement action to negotiate
for an environmental audit is relatively
new.
The inclusion of environmental audits
in enforcement actions is particularly
appropriate. Inspections at some
company facilities may indicate a pattern
of violations which reflect a lack of sound'
corporate environmental policies and
management procedures. That pattern of
violations is likely to be repeated at all of
the company's facilities. Likewise,
environmental audits would also be
appropriate in cases involving any
company which has a history of repeated
significant violations.
An environmental audit may be as
broad or as narrow as the number,
scope, and severity of a company's
violations seem to require. In a narrowly
focused audit, a company with an
otherwise good record of compliance
might be called upon to review only a
small part of its operations which had
been presenting chronic instances of
noncompliance. In its broadest form, an
audit might require a company to
examine its entire environmental
management policies, procedures, and
organizational structure, and programs
affecting all company employees and
operations.
This new dimension to enforcement
will undoubtedly be met with mixed
emotions among the many companies
regulated by EPA. Some will view it as
an investment toward reducing their
exposure; not only to future EPA
enforcement action, but also to the
potential corporate-wrecking
environmental disaster. Others will
oppose what they will characterize as
government intrusion into corporate
management. Environmental audits will
probably be opposed as much over
principle as over costs.
As with any innovative concept, there
are many questions which will be asked
of our agency. Will the company get a
credit against penalties if it agrees to
perform an environmental audit? Will
EPA be entitled to access to the audit
report or its supporting documents? If
the audit report discloses violations of
which EPA was unaware, will the agency
use the company's own report to initiate
an enforcement action?
These are all legitimate questions. To
anticipate and answer them, EPA is
developing a policy on the role of
environmental audits in enforcement
actions. We will attempt to preserve
enforcement prerogatives and capability,
while providing sufficient latitude and
flexibility to give companies the
incentive to perform an environmental
audit.
If EPA is successful in requiring
violators to perform environmental
audits, it will have gone beyond the
traditional enforcement reponse of
addressing only the outward
manifestation of the problem—the
violation—to look behind that violation
for what may be the real cause of
noncompliance. If corporate
management is required to focus on
addressing the root problem—the lack of
environmental management policies and
procedures—then the company, EPA, and
the public will all benefit greatly. D
JUNE 1985
27
-------
Responding to
a Cancer Scare
by Rich Lathrop
Manlier* til on El'A cuiuruclor rrcii>
preserve irufrr .s-am/j/r.s collected Jrvni «
sump /jump in the basement <>l ti home
in l-'riendhf Hills. Coin.
ILdthmp, EPA Region 8 ncu's ojticcr Jor
'.'i i/<'ar.s. is currently on detail in
Boulder County, Colo., under a program
of the Intergovernmental Personnel Act.)
Responding to the public's fears of
cancer and other threats from
environmental contamination can be
costly, complicated, and
time-consuming. And one is never sure
how it will end ... as recent events in
Region 8 well demonstrate.
It all began with a phone call to EPA's
Denver offices from Rebecca Parr. Late
in 1982, Mrs. Parr had begun to think
that her Denver suburb of Friendly Hills
might be misnamed. She had learned
that several children within a few blocks
of her home had developed cancer. Two
had died of neuroblastoma, a cancer
which attacks brain cells. Another had
succumbed to leukemia. And one child
had died of spinal meningitis. Feeling
that the illness rate was unusual for a
neighborhood of about 4,000 people, she
asked EPA for help.
Her information was sketchy at best.
neither comprehensive nor detailed
enough to warrant the immediate
diversion of limited staff and budget
resources from other priority activities.
Nevertheless, she was advised to
document the problem as fully as
possible to clarify the basis for her
concern and the need for an official
investigation.
So Parr set out to gather more
information. Using a questionnaire first
developed by environmental activists at
Love Canal, volunteers canvassed
surrounding homes, asking residents
about unusual health problems
experienced since moving to the area.
The results were disturbing. Within a
one-mile radius of the Parr home, in
addition to the children's diseases, 17
people reported kidney problems. There
were 28 cases of tumors, including four
in children. Neighborhood concern
increased. Environmental and health
agencies began to pay attention.
Also paying increased attention was
Colorado's chapter of the Citizen Action
Network (CCAN). Tied in with the
National Campaign Against Toxic
Hazards, CCAN was actively promoting
reauthorization of Superfund and the
Resource Conservation and Recovery
Act. CCAN linked itself to the emerging
Friendly Hills issue, urging Parr and
other neighbors to go public. The
newly linked organizations fired off a
letter to EPA Regional Administrator
John Welles. They then held a news
conference at which a "cancer map" of
the area was displayed, and official
agencies were charged with being
unresponsive to the situation.
28
EPA JOURNAL
-------
Some public officials were reluctant to
spend scarce time and money chasing
what they perceived to be a
will-o'-the-wisp. After looking at maps,
earlier reports, and the results of various
limited spot investigations, they were
ready to dismiss the citizens' concerns
as unfounded.
But residents needed answers to very
real questions. Can we eat vegetables
from our garden? Can our children play
here? How many other Denver areas are
contaminated with whatever it is? Will
Superfund buy us out? Are we still being
exposed? And, overriding all others, the
questions: When will EPA and the State
of Colorado do something about this?
When will they give us the answers?
Each day, the news media covered
escalating developments. As the
government's response took shape, the
agencies and elected officials urged
citizens to form an advisory group
through which all new information
would be channeled to cut down the
proliferation of anxiety-producing
rumors.
The residents seemed to be divided
into three groups: those who were
convinced there was a menace to their
health; those who felt it was a
rumor-fueled panic which was
destroying their property values; and a
third group willing to wait and see. The
second group urged residents not to
participate in the expanding health
canvassing by Parr and CCAN. Everyone
agreed, however, that more information
was needed.
The residents, of course, wanted quick
answers. Scientists who were called in
wanted to progress deliberately with a
careful sampling plan. Under this plan,
EPA would look for environmental
contamination and the Colorado
Department of Health would check
cancer registries and other medical data
to determine if significant variations in
disease rates were present. The state
was forced to patch a team together to
do this; the health department's
epidemiology section had lost its funding
three months earlier.
Congressman Dan Schaefer (R-Colo.)
hosted a community meeting where the
plans were presented to residents and
other interested groups. By now, the
story had become national news and
some commentary added to the
residents' anxieties by comparing the
situation to Love Canal and the Valley of
the Drums. This comparison was
strengthened one Friday afternoon when
investigators found 62 abandoned
drums across the street from a water
supply that served the troubled
neighborhood. More stories flared up
over the weekend, before it was
determined that the drums were not
leaking and that their contents were not
toxic.
The activists saw the methodical
approach as agency foot-dragging. They
continued their own research and held a
news conference to announce an
"obvious" health hazard the experts had
missed: abandoned uranium mines that
dotted the area.
Was radioactivity the problem? People
began to report strange odors and found
mysterious white crystals on basement
walls. A former county health official
reminded everyone that fires at a
weapons plant several miles away had
released plutonium in 1957 and 1969.
Other commentators raised the spectre
of microwave radiation from
broadcasting towers on a nearby
mountain.
EPA moved to check the mines, invited
citizens along on the inspections, and
quickly discounted the abandoned mines
as a contributor to the problem.
Air samplers were placed in homes
where disease was reported and in
control homes. Outside radiation
concentrations were measured by
hand-held detectors and by an EPA van
equipped with instruments so sensitive
they could register, from the street
outside, radiation from a radium-dial
clock inside. Samples were taken of soil,
surface water, drinking water, and water
that had collected in sumps in
basements. The samples were analyzed
for radium, thorium, uranium, cesium,
and radon gas. Microwave radiation had
been tested and ruled out years earlier.
Conclusion: Radiation was not a
problem.
Similar thoroughness marked the
other sampling work. The area's general
setting was analyzed in terms of geology,
hydrology, history, and weather—aspects
that could be important in interpreting
test results. Samples were collected of
air, drinking water, surface water,
basement sump water, sediments, soil,
and fertilizers used in the area. Analyses
were done on these samples to identify
organic and inorganic chemicals,
pesticides, and heavy metals. By
mid-December, almost all of the 6.500
sample analyses had been completed
and, in the careful and precise language
of the scientists, "no exceedances of
criteria applicable to human health were
observed."
So, no cause was found . . . but what
of the problem?
State health officials, upon completing
their cancer registry analysis, concluded
that the number of childhood cancers
was higher than "normal" but
represented a statistical "clustering of
cases." Such clustering is not unusual
with cancer, nor is the prevalence of the
disease in children—it is the number
two killer of children in America. There
was no pattern which indicated an
environmental threat.
These facts were presented to the
residents in a public meeting. Most were
satisfied and tremendously relieved.
Their children could play outside again.
Realtors could close deals again
(although the stigma still affected
negotiations). Many were anxious to put
the matter behind them and resume
their lives. Some set about closing the
rifts that had opened between
neighbors.
Some residents and reporters pressed
for absolute answers. "Does this mean
the area has a clean bill of health?" The
scientific answer, while reassuring,
wasn't absolute. The exhaustive
sampling plan was designed to look for
environmental contamination that could
account for an apparently high level of
illness in the area. None was found. But
sophisticated monitors had not been
placed in, around, and under each and
every house. Cancer and other health
records had been reviewed, but intensive
health testing was not done on each and
every resident. According to the
scientists, it was possible, though very
unlikely, that some key variable was
overlooked.
Even if those extra steps had been
taken and the same results achieved,
would everybody have been satisfied?
It comes down to a question of
trust—which was why the investigation
was done in the first place. Although
some scientists felt there wasn't
sufficient reason for the probe, and
some managers worried about diverting
staff and money from other priorities.
the public concern had been real and
had to be dealt with. People had been
worried about their family's health and
had turned to EPA and the state for
answers and reassurance. They got both,
and said so at the final public meeting.
Even though no pollutants or toxics
had been found and dramatically
removed on the evening news, the
"danger" had been removed from their
minds. The agencies had served the
community well. D
JUNE 1985
29
-------
Update
A review of recent major EPA activities and developments in the pollution control areas
AIR
Ford Recall
The Ford Motor Company is
voluntarily recalling
approximately 180.000 1981
model year passenger cars to
ensure that the vehicles will
meet federal exhaust standards
for hydrocarbons and carbon
monoxide.
The affected 1981 model year
cars are the Ford Mustang,
Granada, and Fairmont models
and the Mercury Capri, Cougar,
and Zephyr models equipped
with 2.3-liter, four-cylinder
engines. California vehicles were
recalled in September 1984 to
remedy similar emission
problems.
Ford decided to recall the cars
after EPA testing revealed that
they were exceeding the 1981
hydnx-arbon and carbon
monoxide exhaust standards.
The repairs will consist of
modifications to the air injection
system as well as inspection
and—if necessary—repairs of the
exhaust gas oxygen sensor and
exhaust gas reeirculation
system.
Ford will send notification
letters informing owners of the
recall and requesting that
vehicles be brought to Ford or
Lincoln-Mercury dealers where
the repairs will be made at no
cost to the owner.
HAZARDOUS WASTE
Clean Sites
EPA has authorized Clean Sites.
Inc., a private organization
created to expedite private-party
cleanup at abandoned
hazardous waste sites, to begin
considering whether and how
the group should get involved in
the cleanup of 19 sites.
Clean Sites requested
authorization to evaluate these
19 sites under an earlier
agreement In which EPA said it
would indemnify the group
against third-party liability.
Under the indemnification
agreement struck earlier this
year, EPA agreed to Indemnify
Clean Sites and certain
representatives against third-
party liability at preauthorized
sites, up to S5 million per site.
and 810 million per fiscal year.
to be paid directly from the
Superfund trust fund. The trust
fund, earmarked for cleanup of
hazardous waste sites, was
established under the
Comprehensive Environmental
Response. Compensation and
Liability Act (CERCLA).
All 19 sites are on EPA's
National Priorities List (NPL).
That means EPA considers them
candidates for priority long-term
cleanup, either directly with the
aid of Superfund or through
private-party cleanup.
Dioxin Wastes
EPA will regulate the
management of
dioxin-containing wastes, the
agency has reported. The dioxin
wastes will be added to the list
of those subject to the
hazardous waste management
standards of the Resource
Conservation and Recovery Act
(RCRA).
This regulation is a key part
of EPA's dioxin strategy', which
is designed to prevent
mismanagement of
dioxin-contaminated wastes. By
listing these wastes under
RCRA, EPA is taking broader
control over the disposal of
dioxins than it has previously
exercised under the provisions
of the Toxic Substances Control
Act (TSCA). The chemical
2.3.7.8-TCDD was the only
variation of dioxin regulated
under TSCA.
Regulation of Underground
Storage Tanks
Service stations and certain
other small businesses,
industries, and individuals may
no longer install many types of
commonly used underground
storage tanks containing
petroleum products and
hazardous substances. EPA has
announced.
The prohibition is effective
under the November 1984
amendments to the Resource
Conservation and Recovery Act
(RCRA). Under the amended
version of RCRA, EPA is now
required to develop a
comprehensive program to
control the quality and
operation of underground
storage tanks used to store
petroleum products and many
hazardous substances.
The RCRA amendments will
affect as many as 100,000 new
tanks installed each year. They
prohibit the underground
installation of new storage tanks
and piping unless the tank will
prevent releases caused by
corrosion or structural failure.
leakage from these tanks may
result in soil and ground-water
contamination.
From now on, the only types
of underground storage tanks
that may be installed are those
that are constructed of a
noncorrosive material,
cathodically protected, steel-clad
with a non-corrosive material, or
designed to prevent releases of
stored substances. In addition,
material used to construct or
line tanks must be compatible
with the stored substance to
prevent corrosion. An exception
for corrosion protection applies
to tanks located in certain types
of soil.
PESTICIDES
Emergency Pesticide Uses
EPA has proposed revising its
pesticides regulations to clarify
when the agency will grant state
and federal agencies emergency
exemptions to use pesticides for
applications for which they were
not registered.
These proposed revisions were
developed through the
regulatory negotiation process.
This process allows persons
outside EPA with different
interests to actively participate
in the development of agency
rules and regulations. During
these negotiations, all interested
parties can meet face-to-face to
discuss and resolve issues.
The revised regulations would
set stricter conditions for
agencies to meet before EPA
grants them an emergency
exemption.
Cyanazine Review
A special review of the pesticide
cyanazine has been initiated by
EPA after the agency determined
that workplace exposure to this
product may pose an
unreasonable risk to public
health.
The agency's action is based
on data which show that
cyanazine causes birth defects
in the offspring of laboratory
animals and may pose a
significant risk to women of
childbearing age who apply this
pesticide. EPA is principally
concerned with risks from
exposure to cyanazine by
mixer/loader and applicator
personnel. There is no
significant exposure from eating
food crops treated with this
pesticide.
A special review is a formal
public process in which the
agency assesses all the risks and
benefits of a pesticide before
reaching a final regulatory
decision on its continued use.
Cyanazine, a herbicide, was
first registered with EPA in
1971. It is manufactured by
Shell Chemical Co. under the
trade name Bladex. Ninety-six
percent of the cyanazine
produced is used on corn to
control annual grasses and
broadleaf weeds. It is also used
on cotton, grain sorghum and
winter wheat crops.
Dinocap Use To Continue
EPA will allow continued use of
the pesticide dinocap based on
the agency's review of new
laboratory studies undertaken to
determine the product's
potential risks.
In early November 1984,
Rohm & Haas—the sole
manufacturer of dinocap—
voluntarily suspended until April
1, 1985, all sale and distribution
of dinocap products after tests
showed that this pesticide
caused birth defects in rabbits
which were fed with it. Since
then, EPA has conducted
another study which produced
similar effects in mice who had
ingested dinocap.
In the meantime, Rohm &
Haas completed additional skin
penetration and birth defects
studies. EPA has evaluated these
tests. They show that exposure
EPA JOURNAL
-------
Canada goose and goslings near an inland in the
Chesapeake Bay. Preserving the nation's wetlands by
controlling non-point source water pollution is an important
concern of EPA. See story on page 18.
Back cover: An outing on a sunny day. Photo by Edtt'ard
Clark. Folio. Inc.
-------
* -v?
Un/fed States
Environmental Protection
Agency
Washington DC 20460
Third-Class Bulk
Postage and Fees Paid
EPA
Permit No. G-35
Official Business
Penalty for Private Use $300
------- |