United States
Environmental Protection
Agency
Pollution Prevention
and Toxics
(7407)
Fall 1996
EPA749-R-96-001C
Chemicals in the Environment
Public Access Information
TSCA at Twenty
The Toxic
Substances
Control Act at
Twenty
This issue of Chemicals in the Environment
commemorates the twentieth anniversary of the
Toxic Substances Control Act (TSCA) and
provides some of the highlights about the
programs initiated by this law. In the past twenty
years, TSCA underwent numerous changes, and
EPA faced many challenges in its implementation.
TSCA evolved with the enactment of
amendments and new laws, changes in
information technology, and changes in the way
government does business. This
issue will provide insight to
TSCA's past, present, and
future.
Chemicals found in nature and
created in laboratories are at the
heart of our highly industrialized,
technology-based society. They
are found in everyday products
used in our homes, businesses.,
and industry. Chemicals help
protect our health, control pests, manufacture
clothes, provide shelter and serve many other
basic functions considered necessary in today's
society.
The chemical industry plays a vital role in the
economy of the United States. The production of
chemicals and allied products accounts for
roughly five percent of the Gross National
Product employing about 1.1 million
people. Approximately 70,000
chemical substances are presently
manufactured or processed for
commercial use in the United States,
«. and almost one thousand more are
introduced each year.
Although most chemicals present little
or no danger to human health or the
environment when used properly, in the
past few decades some chemicals
commonly used and widely dispersed have been
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Chemicals in the Environment
Fall 1996
Contents
...
The Toxic Substances Control Act at Twenty
Tfestefdt® i
Events Leading Up to the Passage of TSCA, by Frank Kover
:The TSCA OtemicalSab&ance Inventory:
TSCA Sectiott 8(e) Substantial Msfe Reporting and the8(ej CAP, by T«ny O'Bryai
Evolution of the TSCA Interagency Testing Committee, by 3oha Walker
The New Chemicals Program* . A ,
A Legaeyof Progress, by Paul Sickart. ' - ^ ' ' ' * /**
A Legacy of Prevention and l^sfc Reduction, bjrT>avM JDI Fiore
nteOPPTStrattorfeAefivity Team, IsyBsck^ tees , ' ,
OPPT's Cfaemical T«s^ng ft-y Matt Isy S^tt ShWo^s:
TSCA as a Tool for Integrated EnvironntentalManagenrent, by Ciadj^ FoumiCT
CAS Nuinbers? Unique IdentiSer^ E-t Oiemlie^s,, t^ Doug SeB^ns
latortnation CoBectibn, by IMaacy Vosel
Information Dissemination - Past dad Present, by Etoiis BJocfe
3WC4 Tomorrow '' " > » ' <,,"*.'
The Use of Environmental Chemical Databases Witibin OPPT, by Beefy Jones
ErnerrangRight-to-Know Tite«KS ISadter TSCA, by Steve1'!e«i>ere-<1Sisa
New- Caemicals Program Embodies PoBntinn Prevention,, fey R<3g?Seid^stBia
HowOPPT Woits witfe Owtside Partte^<»l»pteiBe»t and Gaia Cwnpaaoce wltb TSCA,
byKenMoss > » < »s ;
Perspectives ' > ^ s .
The legislative History of TSCA, by Wimm Misr
No Rose Garden for the Taste Ssbstssaees: Contol Act, by Glesa Selxweitzer
Ilie Birth ofEPA and TSCA, by Terry Bavfes
.
TSCA Consent Ordter Process for Testing, by Robert M. Sassraaa.
The Program Gatibers Momeatuo*, by DOR it Clay
^ 5 '. '-^ -"- » < V -
Chemicals m&eE»wonmfMt^P»b^A£(:^sI^ormMon}sy^^&\^}^^h^&Q^A of Politttioa
Tftevention aodToxics{OPPT)taiHoreasB^bIjc swareaesssf iautl access to JaformafKHKHi toxic dtatakstis atad
pollution prevention avaaabJetiHau^bLQPFX. Ifeiesoutoejs a&oayailableoin Sie World Wide Web at
http^MTVTV^pa,gov/docs/cie/. Maiuing address: Chemietfls in the Envir&nment- Public Access Information,,
U. S EPA, Office ofPonuSonPreveirficaxand 1oxiKis(7407), 401 MSt, S-.W,*
Advisory Board > ' ' -v
Prefect Manager. {Seorgianae McDi Letty Tabaft, Iffi395; Derase KeamS,
CMD * <», «
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Issue No. 4
TSCA Yesterday
TSCA at Twenty (continued)
found to be significantly harmful. In 1971, the
President's Council on Environmental Quality
developed a legislative proposal, for coping with
the increasing problems of toxic substances. After
five years of public hearings and debate,
Congress and President Gerald Ford enacted
TSCA in the Fall of 1976.
By enacting TSCA, Congress established a
number of new requirements and authorities for
identifying and controlling toxic chemical hazards
to protect human health and the environment.
Programs now exist under TSCA to gather
information about the toxicity of particular
chemicals and the extent to which people and the
environment are exposed to them, assess whether
they cause unreasonable risks to humans and the
environment, and institute appropriate control
actions after weighing then: potential risks against
their benefits to the Nation's economic and social
well-being. Eight product categories are exempt
from TSCA's regulatory authorities: pesticides,
tobacco, nuclear material, firearms and
ammunition, food, food additives, drugs, and
cosmetics. Many of these product categories are
regulated under other Federal laws.
To obtain a copy of TSCA and its amendments,
as well as other documents that will assist in
understanding the scope,of the law, call the
TSCA Assistance Inform
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Chemicals in the Environment
Fall 1996
Events Leading Up to TSCA (continued)
In the summer of 1972, Et^ created the Office of
Toxic Substances ( OTS ) in anticipation of passage
of TSCA. The key philosophical question then was
whether TSCA was an umbrella act or a stop-gap
measure. Most thought it would turn out to be a
catch-all statute. They considered the most
important part of the Act to be the seemingly open-
ended authority in Section 6 to address risky
chemicals with anything ranging from labeling to
outright banning a chemical.
.
OTS was a small staL. opjice under the Assistant
Administrator for Categorical Programs with about
ten people under an acting director. There were
chemists, biologists, a toxicologjst, program
analysts — one serving almost exclusively as the
legislative liaison on the E511-- and two support
staff. The main mission of the group was to support
legislative efforts • with background and Q & A
documents and to identify potential chemical
problems.
EPA used multi-media assessment and other
analytical efforts to define and investigate potential
problems. For example, in May of 1973, a field
investigation team was dispatched to Ascension
Parish, Louisiana to determine the source of
hexachlorobenzene (HCB) contamination in cattle
grazing hi Ascension Parish. They determined a
quarantine zone and recommended an action level
for HCB in fat above which the cattle needed to be
destroyed. (The situation that existed recently in
England that resulted in
cattle being destroyed there
was unrelated to HCB
contamination.)
In 1974, OTS
initiated several
efibrts, mainly
to prepare
literat
u r e
review
fognlafrutom mcroc *ad protect bma*a hu3& «ad ft* environment
ty requiring totting «ad nocenuiy me re*trictio»« oa e«mia chemical
xobttULcac, *ad &r other pmpa«M.
Be it essctod by the Etaute and Howe of Repreuntithw* of the United fitstoc
Of .Asuric* in Coagnu utMmblcd,
SECTION L SHOKiT TITLE AND TABLE OF CONTENTS.
lfek Aot m«y bo o&d u th* Toxio Snbrttaooc Control Act*.
documents on chemicals of potential concern
(categories of chemicals in many cases). In
addition, although personal computers were not
available back then, a couple of projects explored
a then-experimental analytic tool, looking at
chemical structure-biological activity relationships
(SAR) as possible tools for assessing "new
chemicals" with little or no hazard data on them.
(Today our scientists perform this complex set of
comparisons using computers at their desks.)
As time passed, TSCA legislative activity continued.
When Congress did not pass TSCA in one session
of Congress after another, the strategy of OTS
became to perform an early warning service to
identify potential industrial chemical problems. All
the while, the Office anticipated that TSCA would
pass and staff could begin risk management efforts
on those chemical problems identified. OTS devoted
considerable resources to better define concerns
with polychlorinated biphenyls (PCBs), the
"showcase" chemical problem designated for action
by Congress in TSCA.
About this same time there was also a project to
create a "toxics agenda" and prepare a small booklet
on this topic. However, the "filthy fifteen"chemicals
selected for the toxics agenda never really
-------
Issue No. 4
TSCA Yesterday
Events Leading Up to TSCA (continued)
became the Office priorities, probably because not
everyone folly accepted the concept.
While awaiting passage of the Act, many tried to
ensure that actions taken by any one of our sister
Offices were consonant with actions taken (or
contemplated) by OTS and other Offices. This was
done was through active participation on an Agency
Steering Committee. OTS was often seen to be
meddling in the process, perhaps because we
thought the Office had license to pursue problem
analysis on a multi-media basis. However, OTS'
comments were constructive and on balance had a
salutary effect. A good example of their effect was
the Office of Water's implementation of the Clean
Water Act, Section 301 (Effluent Limitations), as
well as other areas like sewage sludge land disposal
and ocean dumping.
Finally, TSCA passed in October of 1976. OTS had
grown to about 40 people since March of 1973.
After waiting four years, final passage of TSCA was
somewhat anticlimactic. Nevertheless, its passage
marked an important change in the treatment of
toxic chemicals in this country that continues to this
day.
The TSCA Chemical Substance Inventory: An Historical Perspective
Henry Lau, Economics, Exposure, and Technology Division
Soon after the enactment of TSCA in 1976, one
of EPA's top priorities was to compile an
inventory of chemical substances, as required
under Section 8(b) of the
Act. The primary
objective of the Inventory
was to define, from a
regulatory standpoint, the
chemical substances that
existed in U. S. commerce
for the purpose of
implementing the New
Chemicals Program.
Substances that were not
already included on the
initial Inventory were
considered "new" and
were subject to the
P r e m a n u f a c t u r e
Notification (PMN)
requirements that would become effective on July
1, 1979.
To ensure a complete and reliable Inventory, EPA
promulgated the Inventory Reporting Regulations
(40 CFR 710) in 1977. These regulations defined
the scope of the Inventory. The challenge that
EPA faced was how to define a workable subset
of commercial chemicals that
would ultimately constitute the
initial Inventory out of the
several million substances
known to exist. Although
Congress specifically excluded
many types of substances (e.g.,
pesticides, drugs, food, food
additives, cosmetics, mixtures,
etc.) from the reporting
requirements under TSCA,
EPA used the Inventory
Reporting Regulations to
further narrow the scope by
exempting such substances as
impurities, byproducts, and
chemicals considered as
"incidentally" formed upon the manufacture,
processing, or use of another substance.
Additionally, to minimize the reporting burden on
the regulated community, EPA required only
those persons who were considered
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Chemicals in the Environment
Fall 1996
TSCA Inventory (continued)
"manufacturers" or "importers" of commercial
chemical substances to report. Generally, most
chemical processors did not have to report.
How to represent the various types of commercial
chemicals that might be reported on the Inventory
was another major challenge for EPA. Since the
Inventory was to perform the regulatory function
of defining what chemicals existed in U.S.
commerce, the chemical listings on the Inventory
had to accurately and unambiguously define these
commercial substances. EPA worked closely with
the regulated community to develop specific
guidelines that would govern how to report
particularly difficult types of these substances,
e.g., petroleum refinery streams, polymers, soap
and detergent chemicals, and substances with an
unknown or variable chemical composition. EPA
recognized that each chemical listing should be
neither too broad nor too narrow. While a broad
listing might encompass too many chemicals and
thus defeat the purpose of the Inventory, an
unreasonably narrow listing would impose an
unnecessary reporting burden for the regulated
community. The close interactions with the
various segments of the chemical industry enabled
the Agency to develop an Inventory that satisfied
the Congressional mandate without imposing an
unreasonable burden on the submitters.
The Inventory was originally intended to be only
a listing of commercial chemicals. However, after
reviewing public comments to the proposed
Inventory Reporting Regulations, EPA decided to
expand the scope to also require the reporting of
plant site location and production volume data for
each chemical. In this way, EPA was able to
develop a more comprehensive profile of the
production characteristics of the chemical
industiy. The Inventory was therefore able to
provide basic information for chemical screening
and priority setting under TSCA. This
information was so useful that EPA subsequently
promulgated the Inventory Update Rule to
require the reporting of current production and
plant site data on a regular basis.
The Inventory is a growing list. EPA adds newly
manufactured chemicals that have completed
PMiM review to the Inventory. Since its
establishment in 1977, the number of chemicals
included on the Inventory has increased from
61,000 to over 75,000 today. The Inventory
continues to function as an important part of
TSCA. Both EPA and the chemical industry
routinely rely on the Inventory to determine what
substances are reportable under the New
Chemicals Program. It has also become the
model for other countries in the development of
their chemical inventories and chemical reporting
regulations.
For further information on the TSCA Inventory,
contact Henry Lou at (202) 260-1555 or by email
at lau.henry@epamail.epa.gov.
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Issue No. 4
TSCA Yesterday
TSCA Section 8(e) Substantial Risk Reporting and the 8(e) CAP
Terry O'Bryan, Chemical Screening and Risk Assessment Division
TSCA Section 8(e) requires industry to report
information on chemicals or mixtures that
reasonably supports the conclusion that the
chemicals present a "substantial risk" of injury to
health or the environment. The kinds of information
submitted typically include results of toxicity studies
using laboratory animals. Studies may relate to
reproductive toxicity, nervous system
effects,cancer, mutation, environmental effects and
exposure, among other areas. This information may
be of value to those working with the chemical that
was the subject of the submission or to others
working with structurally-related chemicals
exhibiting similar properties. If
information has already been published or
submitted to EPA under other
authorities, it is exempt from
8(e) reporting.
The Section 8(e) reporting
requirement began with the
effective date of TSCA on
January 1, 1977. The Agency
published interpretive guidance
in 1978. Since then, EPA has
provided further clarifications
through meetings, question-and-
answer sheets, and other forms
of communication. Up through 1991, the Agency
had received approximately 1,350 new 8(e) notices.
As a result of an enforcement case, EPA suspected
that a large number of companies may not have
been correctly interpreting the 8(e) reporting
guidance. Consequently, in 1991, the Agency
established a voluntary audit program called the
Compliance Audit Program (CAP), It allowed
companies to submit studies that they should have
provided to EPA earlier at reduced monetary
penalties. One hundred twenty three companies
participated; collectively, they will pay over $20
million in penalties. EPA received nearly 11,000
submissions — a majority of the 13,800 8(e)
submissions received to date — under the CAP.
The CAP was to be conducted in two phases.
Phase One covered toxic effects data, while the
second phase was to focus on environmental
exposure data. As a result of Phase One, the
Agency received 10,522 new 8(e) submissions.
Each submission may contain several stetdle^" so the
number of studies received was substantially higher
than the number of submissions.
Because of this large influx of 8(e)
submissions, OPPT found it necessary to
develop a streamlined process to review
the data. Each study
received a hazard ranking
of high, medium or low,
and chemicals were further
screened based on
production volume, uses,
existing risk management
status and other supporting
information. The aim of
the hazard ranking and
screening was, and
continues to be, to identify
candidates for further
assessment or referral. This process makes it
possible to focus limited Agency resources on those
cases that may present the greatest level of
unmanaged risk.
The unpublished 8(e) data have contributed to the
development of risk assessments on a number of
important industrial chemicals, such as glycol ethers,
formaldehyde, acrylamide and 1,3-butadiene. The
assessments, in turn, have prompted a number of
risk reduction activities by EPA, OSHA and the
chemical industry. EPA encourages 8(e) submitters
to report all voluntary risk reductionand risk
management actions as part of the 8(e) notices.
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Chemicals in the Environment
Fall 1996
The 8(e) CAP Program (continued)
Data submitted under Section 8(e) ho» also been
used on a regular basis to support the OPPT New
Chemicals Program. It is stored in a data base that
uses structure-activity relationships to predict the
toxicity of new chemical substances submitted by
industry in premanufacture notices required under
Section 5 of TSCA.
In June of 1991, EPA suspended it's reporting
guidance for exposure data. The guidance and
requirements for toxic effects dafey representing the
majority of 8(e) reporting, remained*!? effect. The
Agency announced that the second phase of the
CAP would be conducted only after revised
exposure guidance had been published. However,
Phase Two was canceled after the Agency
concluded that the submission of old exposure data
would be duplicative and would most likely have
little value in identifying or assessing current risks.
Thus, the Agency is in the process of formally
closing the CAP.
In the meantime, EPA proposed revised exposure
guidance in the Federal Register in July of 1993.
This guidance tries to avoid duplicative reporting
without losing the opportunity to obtain information
on previously unreported situations of widespread
environmental contamination. Based on the
comments received, EPA revised the proposed
guidance and provided another opportunity for
public comment in March, 1995. EPA hopes to
have the new guidance ready for publication in late
1996 or early 1997. Concurrently, EPA is working
with industry representatives to develop a question-
and-answer document that will further clarify the
guidance through the use of numerous case
examples. When the final exposure - related
guidance is published, it will be prospective; that is,
information obtained before the guidance was issued
will not need to be reported.
Complete copies of all 8(e) studies are available at
the OPPT Public Docket and on microfiche from
the National Technical Information Service (NTIS).
All 8(e) studies are indexed by a variety of terms,
such as CAS number, chemical name, submitter's
name, and study type. They are included in the
TSCA Testing Submissions data base, which is
available as part of the National Library of
Medicine's TOXNET System and a commercial
data base called Chemical Information System.
"Status Reports" or "Submission Summaries" were
prepared on all submissions through fiscal year 1991
(approximately 1,350 submissions) and are available
through the TSCA Public Docket. Additionally,
bound volumes of status reports through 1990 are
available from NTIS. The results of "triage" hazard
evaluation and screening of CAP studies and other
recent 8(e) studies are captured in an electronic data
base available to the public. The current product,
which contains only a segment of the CAPs, is
available on diskette and EPA's World Wide Web
Site on the Internet. Over 500 copies of the data
base have been distributed on diskette, and it is
accessed by approximately 30 users per month on
the Internet. The revised version of the Triage
information product will include all CAP
submissions, in addition to other recent 8(e)
submissions. It is expected to be available to the
public by early 1997.
8,
-------
Issue No. 4
TSCA Yesterday
Evolution of the TSCA Interagency Testing Committee
John D. Walker, Office of Pollution Prevention and Toxics
Introduction
The Interagency Testing Committee (ITC) was
created by the U.S. Congress under Section 4(e)
of TSCA as an independent advisory committee
to the EPA Administrator. Its purpose was to
recommend chemicals to which EPA should give
priority consideration when requiring chemical
testing under TSCA Section 4(a).
i'Q 16 U.S. Government organizations
represented on the ITC, including the EPA,
Consumer Product Safety Commission, Interior
Department, Food and Drug Administration,
National Cancer Institute, National
Institute of Environmental Health
Sciences, National Institute for
Occupational Safety and
Health, and the Occupational
Safety and Health
Administration.
The ITC is responsible for
establishing the TSCA Section
4(e) Priority Testing List,
revising the List at least every
six months, identifying and
coordinating the Federal
Government's data needs for chemicals
on the List, and recommending these chemicals to
the EPA Administrator for further action. The
ITC meets monthly as a full Committee to satisfy
its responsibilities under TSCA Subcommittees
of the ITC form partnerships with the producers,
processors and users of recommended chemicals
to discuss Federal data needs. The Committee
also reviews and summarizes unpublished data for
recommended chemicals and transmits semiannual
Federal Register reports to the EPA
Administrator.
Since its creation, the ITC has:
> convened 270 meetings;
*• issued testing decisions on 40,000
chemicals;
> recommended 3,500 chemicals for testing;
* established dialogue groups with 30 trade
associations;
*• reviewed 30,000 unpublished studies;
*• prepared 1,500 chemical dossiers; and
> transmitted 39 semiannual reports to the
EPA Administrator.
The history of the ITC was recently published hi
a peer-reviewed book (Walker, 1993,451-509).
1970-1976 -
The ITC was created after several
years of intense debate hi Congress
over proposed toxic substances
control legislation. In 1970, the
President's Council on
Environmental Quality expressed
concern about chemicals that
were not regulated under the
Federal Insecticide Fungicide and
Rodenticide Act and the Federal
Food Drug and Cosmetic Act and the
need for a committee to coordinate
interagency concerns on chemical testing.
In 1971, the Nixon Administration proposed toxic
substances legislation. It was passed by the U.S.
House of Representatives and the U.S. Senate,
but compromise could not be reached. Two years
later, hi 1973, the Chemical Manufacturers
Association (CMA) lobbied Congress for a study
to address the need for toxic substances
legislation. In 1975, two bills that addressed
chemical testing were proposed. One proposed
that all existing chemicals be tested within five
years of TSCA enactment; the other proposed
creation of an independent advisory committee to
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Chemicals in the Environment
Fall 1996
ITC (continued)
the EPA Administrator to recommend a
prioritized list of chemicals for testing. On
October 11, 1976, TSCA was enacted with an
effective date of January 1, 1977, and the ITC
was created.
1977-1980
When the ITC was established, the TSCA
Inventory from which chemicals could be selected
for recommendation to the EPA Administrator
had not yet been created. To implement ITC's
statutory agenda, member organizations provided
lists of chemicals for which there were concerns
about the adequacy of test data. The ITC
organized a Chemical Scoring Workshop to
prioritize these chemicals for consideration. From
the ITC's first meeting hi February 1977 to its
117th meeting hi October 1980, all the chemicals
that were deferred or recommended in ITC
Reports 1 through 7 were from the first Chemical
Scoring Workshop.
1981-1988
Chemicals chosen for consideration from 1981 to
1988 were selected from Chemical Storing
Workshops; chemicals were deferred for testing
or recommended in ITC Reports 8 through 24.
1989-1996
Chemicals selected for consideration from 1989
to 1996 were nominated by ITC members
because their organizations had clearly defined
data needs for these chemicals. In addition, the
ITC organized subcommittees to review,
prioritize, and coordinate these daiaja?eeds;
developed a computerized system for idv^Jrying
potentially hazardous chemicals in chemical
groups; and established partnerships with the
CMA and other trade associations to discuss the
needed data and develop databases of
unpublished studies.
References
Walker, J.D. The TSCA Ihterageney Testing Committee,
1977 to 1992: Creation, Structure, Functions and
Contributions. In Environmental Toxicology and Risk
Assessment: Second Volume (ASTM STP 1216). eds.
Joseph W. Gorsuch, F. James Dwyer, Christopher G.
Ingersoll, and Thomas, W. La Point, 451 -509. Philadelphia:
American Society for Testing and Materials, 1993.
The New Chemicals Program: A Legacy of Progress
Paul Bickart, Economics, Exposure and Technology Division
In July of 1979, the first premanufacture notices
(PMNs) began arriving at EPA These notices
are required under TSCA for new chemicals that
manufacturers want to produce for the first time.
We expected, at most, a few hundred notices a
year. A study prepared for the Agency projected
that, if testing and paperwork costs were kept
low, the American economy might be able to turn
out 400 new chemicals a year. That was
considered optimistic. Thus, after receiving
30,000 notices, we are at a fine vantage point for
looking back on the past twenty years.
The initial, few PMNs gave only a few hints of
changes brewing in the chemical industry. Even
so, in the first year there were suggestions of a
trend toward manufacturing chemicals that were
better from an environmental point of view.
.fO-
-------
Issue No. 4
TSCA Today
Legacy of Progress (continued)
Examples included the synthesis of a pesticide
with negligible toxicity toward mammals and
birds, a resin to increase the tread life of tires, and
a new lubricant derived from a renewable source.
As the flow of notices increased, we started to
see other trends emerge. When crude oil prices
were high, we saw a surge of energy-efficient
coating materials. When the fear of an oil crisis
abated, use of some energy-efficient coatings fell
off in favor of less costly solutions. At the;
.time; use of other coatings continued to
Why? The other coatings met strict new air
quality standards to lower the emission^* volatile
organic compounds.
Nearly half of all notices werelied for polymers,
a class of chemical distinaMied by tfear Mg$l
molecular weight amr repetitive ctiessbai
structure. ^_^After~yljars of experience* we
recognize< i tftat about hajf of all polymers
presented DO real risk to tbalt& or
environmei ft, either because of thek <
or their pn >|>eities,' We devised chemical <
to classify feese relatively sde j
expedited internal, review^ fad IjTl^S^ lot
exemption from seme of the rigors of PMM
reporting.
expanded
for
steps, we i
in 1995, the polymer exemption wa&
6 eliminate PMN reporting altogether
jyja.ers, (MotwithsJanding these
1 get maayaotice^Jfer polymers.)
The PMN^xro^essl^fieettdtie growth of the
microelectronic revolution. Somt
have been created for the semiconductor itself,
while others are for photolithographic
manufacture of the microchips, like photoresists,
contrast enhancers, and sensitizing dyes. Still
: for peripheral devices, such as liquid
display devices, dyes for inkjet
\colorants for sublimation-transfer
, an i charge-control agents for toners for
/laser jjrlnt« rs, to name a few.
M tbe las^ couple of years, we have seen an
trend towards inherently safer
is, design of safer and less waste-
chemical processing, and greater
recycling of wastes and byproducts. We are
encourage these trends
_ such as
C&engs&y''"' Cfeateage \and the
L Technologies Mtiative.
trends &st we
l&e
We looked forward to i
we not yet
;echnology
would have produced more jPMNs by
icals for
iut we have
to see more
but as long
in the
re supercoi
iyoae
jerials from renewable:
LcaHwek>|^tosee,mfatafePMNs? Asa
[ a long-time scienee.fiction buff, I am
Jooktag §Mward to self-assembUng molecular
and eventually, a whole new chemical
iustry based on nanotechnology - but I am not
holding my breath.
The New Chemicals Program; A Legacy of Prevention and Risk Reduction
David Di Fiore, Chemical Control Division
As we recognize the 20th anniversary of TSCA,
the New Chemicals Program is nearing a major
milestone of its own—the review of 30,000 new
chemical notifications. Since the implementation
of TSCA, the New Chemicals Program has acted
as gatekeeper for new chemicals seeking to enter
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Chemicals in the Environment
Fall 1996
Legacy of Prevention (continued)
the commercial marketplace in the U.S. Only
those chemicals that can be manufactured,
processed, used and disposed of in a safe manner
are allowed unrestricted market entry.
Substances that present unacceptable risks to
human health or the environment may be
restricted entirely from commerce.
While the vast majority of chemicals proposed for
manufacture do not pose a concern for human
health or environmental effects, a significant
minority do—about 10% of all submissions or
roughly 200 chemicals per year. In these cases,
OPPT raises a cautionary flag by taking some
form of regulatory action. For example, the
program might require testing prior to any
nranufacture, to refine the toxicity and risk profile
of a chemical. Testing might be followed up with
certain control measures, for example, a
restriction of releases to water. Or, manufacture
might be allowed without prior testing only under
specified conditions, such as restricting discharges
to a stream or landfill or providing workers with
protective equipment.
Requiring chemical manufecturers and processors
to implement protective measures limits
exposures to potentially toxic substances and
thereby lessens the risk of harm to people and
their environment. The potential beneficiaries of
these actions are many. They may include, for
example, the worker who weighs or. mixes
substances at a chemical plant, the environment
and aquatic life surrounding a facility, and the
individuals living hi a plant's vicinity who might
drink water from nearby rivers or wells
or eat fish from
local streams.
Many times the
harm that is
avoided involves
chronic effects, like
cancer or lung
disease, which m
-------
Issue No. 4
TSCA Today
The OPPT Structure Activity Team
Becky Jone^; Health and Environmental Review Division
The OPPT Structure Activity Team (SAT) is a team
of expert scientists, including chemists, biologists,
lexicologists, and information specialists. The
function of the SAT is to evaluate the potential
health and environmental hazards and environmental
fate of chemicals through the use of chemical
structure - biological activity relationships.
(Chemical structure - biological relationships, or
SAR, refers tQ^the-link between a chemical's
structure and -ib- effects on people and
environmental organisms.) A hazard assessment
developed by the SAT relies on available test data
(although frequently little or nothing is known about
the chemical) and expert judgment to provide a
preliminary 'assessment of chemical hazards and
environmental fate.
The health hazard assessment includes a description
of the potential for a chemical to be absorbed
through the skin, lungs, and intestinal tract. It also
identifies how the chemical may be changed in the
body and the potential for the chemical to cause
acute toxicity, neurotoxicity (effects on the brain
and other nerves), effects on internal organs such as
the liver or kidneys, bath defects, infertility, effects
on DNA, and cancer, if exposure to the chemical
occurs.
The environmental fate profile predicts how quickly
the chemical will degrade if released into the
environment. Additionally, the potential transport
of the chemical through the environment is
predicted. The environmental hazard profile judges
how toxic the chemical will be to plants and
environmental organisms living in water (such as
fish) or on land (such as birds).
Important factors in developing hazard assessments
are information on the subject chemical, information
for structurally similar chemicals, known toxicity of
chemical classes or parts of a chemical, and the
knowledge and judgment of SAT members.
| Joseph Seifter; MIX* one of &e osgtual members of OPPT's celebrated
Stmetare AetiyitjrTeasa, was a remarkable individual and. scientist who
-was cental to the earfy technical development and establishmentof the
SAT. Dr. Settler's work with, the SAT eapped1 an eminent career
spanning more titan 50 years which produced major eontribatiofls in
basic medical research and outstanding service as-a teacher,
experimentalist (over 200 scientific publications), administrator, and
sctefttifie advisor, Br, SeSler*s profound understanding of the cbernksal
basis of pharmacology and toxicology was seminal in establishing aad
guiding the SAT through; its early years. His death ia 1982 brought a
remarkable career to a. close. Though we mss Mm still, the analytic
approach, insights* aad technical: excetence wMch. he exemplified., and: freely extended to others as
botl a coBeagpe and mentor coaHnoe to fesosate ia tiie SAT asd k the careers of <&e jaany
ittdividoab i^asejive£ %e fofdied wi enriched; — CfiorfesM. AwrjEwectaf^ Chemical Control
.13.,
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Chemicals in the Environment
Fall 1996
Structure Activity Team (continued)
The SAT was originally formed in 1979 to evaluate
new chemicals (that is, chemicals not currently made
or used in the U.S.) submitted to OPPT under
Section 5 of TSCA. Since that time, the SAT has
evaluated over 30,000 chemicals. Today, the SAT
reviews over 2,500 new chemicals each year. The
SAT is also called upon to screen chemicals which
are already being made or used in the U.S. Over
3,500 existing chemicals have been evaluated for
OPPT and other EPA offices, including regional
offices and other government agencies.
During the past year, the SAT
evaluated approximately 60
chemicals in support of EPA's
Office of Solid Waste for two of
their hazardous waste listings. The
SAT also evaluated over 50 chemicals
for the Office of Air and Radiation as
an early step in identifying
replacements for chlorinated solvents and
chlorofluorocarbons (CFCs) that are being phased
out because of their effects on the ozone layer.
Presently, the SAT is in the process of evaluating
approximately 1,500 inactive ingredient chemicals
added to pesticide products.
The SAT interacted with the U.S. chemical industry
to share the SAR principles routinely used in
evaluating chemicals. Ideally, this type of
cooperation will result hi the design and use of less
toxic chemicals.
The SAT recently participated in a joint study with
the European Union (EU) to determine how well
the SAR methods employed by the SAT work. The
SAT evaluated the chemicals in the usual way and
then compared the assessments to the results of
studies that were submitted to the EU. This'
exercise found that the SAT was
highly successful both in predicting
the environmental fate and
environmental hazard and
identifying potential human health
effects of the chemicals. Since
that time, the methods employed by
the SAT have been studied by the
Canadian, Japanese, and Australian
governments, as well as the members of the
European Union, for possible use hi programs to
screen chemicals that are of concern in their
respective countries.
For more information about the SAT and the risk
assessment process for chemicals see the Winter
1995/1996 issue oj Chemicals in the Environment
OPPT's Chemical Testing Program
Dave Williams, Chemical Control Division
Under the Toxic Substances Control Act (TSCA) of
1976, EPA is given broad authority to gather
health/safety and exposure information on, and
require testing of, chemical substances and
mixtures. TSCA states that "it is the policy of the
United States that adequate data should be
developed with respect to the effect of chemical
substances and mixtures on health and the
environment and that the development of such data
be the responsibility of those who manufacture [and
import] and thosewhoprocess such chemicals and
mixtures." This article provides a brief history of the
TSCA ChenricalJesting Program in EPA's Office of
Pollution Prevention and Toxics (OPPT).
Before requiring companies to test chemicals, EPA
reviews numerous publicly available data sources as
well as the data we collect through our reporting
rules. Based on this information, we must decide
that:
.14.
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Issue No. 4
TSCA Today
Chemical Testing Program (continued)
1. Existing data show that the chemical "may
present an unreasonable risk of injury to
health or the environment" and that there is
probably exposure; and/or
2. The chemical is produced or imported in
substantial quantities, and, either enters the
environment in substantial quantities pi
results hi significant human exposure; and
3. Existing data cannot reasonably predict
human health or environmental effects; and
4. Testing is necessary to develop adequate
data to conduct a risk assessment.
In the early years of TSCA, EPA used a
complicated two-phase rulemaking process to
require chemical testing under Section 4 of TSCA.
In the first phase, following issuance of a proposed
rule for public comment, EPA issued a final rule
identifying the chemicals and the type(s) of testing
required. This final rule required industry to submit
test protocols and study plans for EPA review.
EPA accepted the protocols (including public
comments on them) through a second rulemaking.
This approach gave the chemical industry a
maximum amount of flexibility in developing testing
protocols, but it proved very cumbersome. In fact,
EPA was sued by the Natural Resources Defense
Council (NRDC) in 1980 because the Agency was
not meeting its statutory deadlines for Test Rules on
chemical designatedfor testing by the TSCA
Interagency Testing Committee (ITC). ( See
Walker article this issue.) The Agency launched an
effort to obtain testing via "Negotiated Testing
Agreements" (NTAs) with the chemical industry.
This effort was successful in many ways and
resulted in important dialogue between EPA and the
chemical industry. However, the NTA process
lacked public input and enforceability under TSCA,
which resulted hi another NRDC lawsuit in 1983.
The court found the NTA process illegal.
In collaboration with NRDC and the Chemical
Manufacturers Association (CMA), EPA developed
a formal "Enforceable Consent Agreement/Order"
(EGA) process hi the mid-1980's that encourages
public participation. EPA also streamlined the
process by developing formal Test Guidelines,
which allows EPA to simply cite the appropriate
testing methodology in Test Rules. In the mid-
1980's, therefore, EPA felt that it was well on its
way to affecting a strong Chemical Testing
Program.
The Program had continuing legal challenges,
however. During the mid-1980's, CMA and EPA
agreed that EPA's risk finding (#1 above) is based
on both the toxicity of the substance and exposure
to it. However, CMA and EPA differed over three
specific questions — whether EPA: (a) must find
that an unreasonable risk is more-probable-than-not,
(b) must specifically rebut any industry evidence
suggesting no human exposure by direct evidence of
exposure, and has the authority to issue a test rule
where any individual's exposure is an isolated, non-
recurrent event. In response to a lawsuit filed by
CMA, the court upheld EPA's views that a Test
Rule is appropriate where EPA has substantial
reason for suspecting that some amount of exposure
takes place and the chemical is sufficiently toxic at
that exposure level to present an "unreasonable risk
of injury to health."
In the late 1980's, CMA again sued EPA, charging
that the Agency had not sufficiently developed and
publicized its
criteria for making
the substantial
exposure finding
(#2 above). This
lawsuit delayed the
Program for over
three years while
the Agency
developed and
officially
announced its
-------
Chemicals in the Environment
Fall 1996
Chemical Testing Program (continued)
criteria in 1993. Although EPA still was able to
obtain some testing through EGAs, the Agency also
looked to voluntary industry initiatives to bolster the
Testing Program. EPA encouraged members of the
chemical industry to initiate voluntary testing
activities to develop data needed to protect human
health and the environment. EPA now has 3 primary
tools to obtain testing: Test Rules, EGAs, and
Voluntary Testing Agreements.
EPA continued to receive much criticism from the
U.S. Congress and others about the slow pace of its
testing program in the early 1990's. Along with the
issuance of the exposure criteria in 1993, OPPT
issued a Chemical Testing Program Vision
Statement with the following goals:
>• Increase the overall productivity of the
Chemical Testing Program;
>• Establish a clear agenda for chemical
testing;
»• Ensure that testing is directed toward
meeting data needs, not just filling data
gaps;
*• Redefine success to recognize the
contributions of each of the 3 primary tools
to fill data needs;
*• Emphasize pollution prevention initiatives to
reduce exposure or risk as a possible
substitute for, or adjunct to, testing;
*• Promptly review and evaluate test results;
and
*• Improve internal and public access to test
data and EPA reviews.
Finally, OPPT has developed a "Master Testing
List" (or MTL) to establish the agenda and priorities
for the Testing Program and to serve as a
cornerstone by presenting the universe of existing
chemicals that have the greatest need for testing.
The MTL identifies the testing needs of the federal
government and international programs of U.S.
interest (e.g., Organization for Economic
Cooperation and. Development (OECD) "Screening
Information Data Set" (SIDS) * xogram. See CIE,
Spring/Summer 1996, pp. 14-15.) Based on broad
public input, the MTL both focuses on priority
chemical testing needs
and publicizes those
priorities, to encourage
voluntary industry
testing. Listing on the
MTL occurs via formal
requests from other
EPA Program Offices,
from other Federal
agencies, from within
OPPT's Existing Chemicals Program (see CIE,
Spring/Summer 1996, pp. 11-12), or by way of
designations by the TSCA Interagency Testing
Committee.
It is important to note that'OPPT has been using the
MTL since 1990 to set the agenda for the Chemical
Testing Program. Since 1979, about 550 chemicals
have been tested (almost all of these are U.S. High
Production Volume or HPV chemicals), and more
than 50% of these actions occurred in the last
several years. In addition, EPA has issued
approximately 250 TSCA 4 Section "Decisions-
Not-To-Test" since 1979; many of these DNTs have
also involved HPV chemicals. The MTL currently
contains over 500 specific chemicals and more than
15 categories - virtually all of these are currently in
testing or a testing action is under development. A
revised MTL, which also contains a list of those
chemicals removed from the MTL (because, e.g.,
testing has been completed), was issued on
December 13, 1996 (see 61 Federal Register
65936).
Today's TSCA Chemical Testing Program can be
characterized by the following attributes:
> EPA has a clear testing agenda; the MTL
presents a consolidated public list of the
priority industrial chemical testing needs of
EPA and other Federal agencies;
.16-
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Issue 4
TSCA Today
Chemical Testing Program (continued)
»• More chemical testing is being conducted --
more than 300 tests are underway, and
OPPT is developing testing actions on over
200 chemicals;
>• EPA will continue to develop testing actions
by using a mix of Test Rules, Enforceable
Consent Agreements, and Voluntary Testing
Agreements.
»• Many U.S. chemical companies appear
willing to conduct testing and to establish
voluntary product stewardship programs for
their chemicals;
*• International efforts such as the voluntary
OiiCD/SIDS testing program continue to be
integral to OPPT's Testing Program, and we will
continue to encourage U.S. industry participation;
> Enforceable Test Agreements and Voluntary
Testing Agreements offer an increased role
for pollution prevention and risk reduction
measures as an offset to some testing;
> Efforts are underway to further improve
public access to OPPT test data.
Evolution of Risk Management of Existing Chemicals Under TSCA
Ed Brooks, Chemical Control Division
Birth of Section 6
From 1971 to 1976, while several toxic
substances control bills were being debated in
Congress, three concerns animated the drive for
an authority to control existing chemicals (i.e.,
commercial chemicals already in production):
» The cancer mortality rate had been
accelerating since before World War II;
> Industrial chemicals were believed to be a
major cause of the increase; and
> Authorities to control many problems
posed by industrial chemicals were either
non-existent or inadequate.
Prevailing opinion regarding the first two
concerns was captured in Dan Rather's
introduction to a CBS documentary, aired at the
time, entitled The American Way of Cancer:
"The news tonight is that the United
States is number one in cancer. The
National Cancer Institute estimated that if
you're living in America your chances of
getting cancer are higher than anywhere
else in the world. Evidence indicates a
link between rising cancer rates and
industrialization, and we have led the
world in both."
The third concern was articulated in a 1971
Council on Environmental Quality (CEQ) Report
entitled Toxic Substances, which noted that:
•> The Federal Water Pollution Control Act
had no authority to regulate specific toxic
chemicals in effluents;
*• There was no Federal authority to
regulate disposal of toxic substances; and
»• There was no Federal authority to
regulate toxic substances in consumer
products that were not food, drugs or
pesticides.
Moreover, even where adequate authorities did
exist to control toxic substances, the reach of
those authorities was restricted to particular
environmental media (such as air, water, or land)
or to particular settings or applications (such as
workplaces, food, drugs, or pesticides). A
Federal authority was needed that could
effectively address risks posed by toxic chemicals
found in more than one medium or setting or that
could move from one type to another.
-.17-
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Chemicals in the Environment
Fall 1996
Risk Management (continued)
juased on these concerns, the CEQ recommended
passage of a Federal authority that would fill the
regulatory gap by, among other things,
empowering EPA "to restrict or prohibit the use
or distribution of a chemical sub
restriction were necessary to prot
the environment". Congress
enacting Section 6 as part of TS
section provided not only the authority,
restrict production or use of toxic chi
also to regulate disposal of such chemi
require labeling and notification
Following enactment, questions
whether TSCA was actually intend
regulatory gaps, or whether it was int
a broader "umbrella" role, when
become the primary Federal statut
with toxic substances. In either
anticipated that, at a minimi
chemical problems not effe
under other statutes would be
by rules promulgated under S;
limit use of chemicals that
risk — where unreasonable
somewhat imprecisely
outweighing the benefits
To this end, EPA's Offii
(subsequently renami
Prevention and Toxi
next several years
chemicals that (1)
standard, and (2) w;
other authorities.
The Early Years
That goal proved elul
apparent hurdles to bi
unreasonable risk standan
Congress subsequently enacted other statutes that
essentially closed the void Section 6 was designed
to fill.
With respect to the unreasonable risk issue, after
taking action under Section 6 to curb aerosols
containing chlorofluorocarbons (CFCs), the
Agency came to view Section 6 rulemaking as an
?pnd complex undertaking that
*'i>ect of resulting in success.
to new legislation, following
CEQ report Congress passed
Conservation and Recovery
lorizing Federal control of
of toxic substances;
ater Act, authorizing, for the first
regulation of specific toxic
s hi effluents;
Product Safety Act,
among other things, banning
iroducts posing unreasonable
and the
Water Act, authorizing the
tent to establish maximum
ions of specific
lie water supplies.
subsequently
•egulatory gap
to address.
;es between
ctory situation,
sparsely. The
of
that,
to ban or
chlorinated
;hromium, and
iis period, successive
administrations became increasingly aware of
both the difficulty and the inefficiency — hi an
area fraught with uncertainties — of attempting to
CO
risks of
Safe
federal g
Ibwable
anees
•w. ipartjibecause of the
.18=
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Chemicals in the Environment: Public Access Information
(Supplement to Issue No. 4)
Some of the many people instrumental in creating and implementing the Toxic Substances-Control Act have
agreed to share their personal recollections about TSCA. Chemicals in the Environment thanks them for
sharing their thoughts with us. <• ~ •' -
In the Creation of EPA Lay the Seeds of TSCA
~ Terry Davies, Director, Center for Risk Management, Resources for the Future
(Assistant Administrator, Office of Program Planning and Evaluation, »1989-1991) T
One of the things that makes life both interesting and
confusing is that each of us mentally writes history from our
own unique and sometimes peculiar vantage point. For me, the
creation of EPA and the origins of TSCA are jntertwined. .
* -v jf
In 1967, having spent two'years as (ttie first ever) budget
examiner for environmental programs at the Bureau of the
Budget (now the Office of Management and Budget), I
returned to academic life. Like all good academics, I had to
write a book. Naturally enough, I wrote one entitled The
Politics of Pollution,'-which was published early in 19JO.'
According to the conventions of the day, books of this kind
had to have a concluding chapter that made recommendations
to cure all the ills that had been identified in the previous
chapters. In my concluding chapter I wrote:"*'
"Each year hundreds of new'chemical
compounds and new uses for existing chemicals -
and,metals are being intrbduced'in the United ^ ,
States.' And this is done -with little regard for
their effects on human health or on ecology.... > "
What is needed is a Federal agency -with'
responsibility for determining the health effects
of all such substances^ setting standards for
human exposures to them, registering and
'approving new chemicals, and monitoring the
^course ofsuch^substances in the environment,
thus tracing the sources of human exposure,"
In 1969, as a consultant to the President's Advisory Council •
on Executive Organization, I worked on the new Federal
-agency which became EPA. When I went to work for the
Council on Environmental Quality the following year; one of
my first projects was to draft legislation for "registering and
approving new chemicals." I was assisted by Charles Lettow,
a young lawyer who was also a chemical engineer.- The
, ;chemicals legislation was; cfrafted"af-the^ same time that
Congress was 'considering the reorganization plan to create
EPA. Forme, the legislation that became TSCA was intended
to take the same holistic, integrated, balanced approach to
environmental problems as the new agency. Neither the
" legislation nor the agency exactly turned out that way - a sad
commentary on both the pollution control system and my
ability as a forecaster. "/
The Passage of TSCA: A Lesson in Compromise ,
_ Warren Muir, President, Hampshire Research
(Director, Office of Toxic Substances, 1977-1981)
The fact that TSCA, unlike virtually any -other federal
environmental law, has had no significant amendments since
its original passage in 1976 does not mean that its legislative
history was uneventful. On the contrary, (differences over the
vision of toxic substances control legislation were so great that
it took three full congresses before a compromise version was
passed.
Competing versions were passed in each House by large
margins in 1972,1974, and 1976. The Senate wanted all new
TSCA Perspectives
_ P-1 -_
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Chemicals in the Environment
FalM 996
chemicals registered by EPA after premanufacture review.
The House of Representatives wanted EPA review limited to
those new chemicals that EPA, by rule, listed as high priority
concerns.
The compromise struck was the current system in which EPA
is given notice at least 90 days in advance of manufacture and
supplied with existing information. (No testing is required.)
If EPA does not act within the review period, the new
chemical can be manufactured freely. If EPA finds during the
review period that the chemical may, pose an unreasonable
risk, it can seek to prohibit or restrict the chemical's use
pending the development of additional information. If the
submitter objects to EPA's finding, EPA must go tojiourt
before the end of the review period and obtain a court order to
impose its determination.
In the I970's, it was taking EPA years to register a relatively
few new pesticides. Many observers felt at the time of
enactment that the compromise would fail because of the
burden on EPA to act on hundreds or thousands of poorly
characterized chemicals in a 90-day period, requiring this
aspect of TSCA to be revisited quickly.
Even after Congressional action on this compromise, its fate
was uncertain as President Ford seriously considered vetoing
the bill, even though the idea of TSCA was originally aNixon
administration proposal that had been supported by President
Ford. In the end, with the urging of both the Manufacturing
Chemist Association (now the Chemical Manufacturers
Association), organized labor, and the environmental
community, he signed the bill into law.
Looking back now, it is clear that the new chemical review
program that was the big compromise after contentious debate
has been TSCA's greatest success. More than 20,000 new
chemicals have undergone EPA premanufacture review. On
nearly 10 percent, EPA has acted to restrict use and/or obtain
more data. No EPA orders have been challenged in court.
And most importantly, none of the environmental problems of
concern today seem to be tied to chemicals that have been
reviewed under the law.
No Rose Garden for the Toxic Substances Control Act
[from Glenn Schweitzer, former Director, Environmental Monitoring Systems Laboratory, Office
of Research and Development, in: Borrowed Earth, Borrowed Time, Healing Amen'ca's
Chemical Wounds (Plenum, 1991)]
When TSCA finally overcame all the hurdles in the Congress
and arrived at the White House for signature, President Ford
delayed his response to the very limit of the time allowed until
a pocket veto would take effect. Only a few hours remained
when he finally signed the legislation into law in the privacy
of his office in October 1976.
But why did he delay? Why didnt he celebrate the passage of
this complicated legislation with a signing ceremony in the
rose garden? Environmental and industrial leaders,
congressional and cabinet officials, and labor and foreign
trade executives who had repeatedly clashed during the
incubation of the legislation could have joined hands in an
unusual display of national consensus. President Ford's
campaign for reelection desperately needed demonstrations of
support from all sides. Perhaps the President's staff correctly
judged that the new legislation was politically insignificant in
comparison with education, welfare reform, crime, and other
social and economic issues confronting the nation. Perhaps the
impassioned congressional debates, the intensity of the
lobbying efforts, and the media accounts of the cancer crises
had exaggerated the threat of toxic chemicals. But isn't
legislation that could affect the daily workings of tens of
thousands of industrial firms throughout the country of
considerable importance? The White House inner circles
wanted the chemical problems which regularly punctuated the
Washington Post and the New York Times to go away. After
struggling until the last minute to understand the complicated
provisions which Congress had crafted, they undoubtedly
concluded that the new legislation would help, even though
it could hardly be considered monumental in their eyes.
Meanwhile, the Chemical Manufacturers Association and the
Chamber of Commerce had advised the White House of their
desires to have the legislation signed and thereby end the
regulatory uncertainty that had hung over the chemical
industry for five years. The Sierra Club, the Natural
Resources Defense Council, and other environmental groups
assured the presidential aides that their concerns had been
addressed. The AFL-CIO argued that safety was even more
important than jobs and that the law should be enacted. The
Office of Management and Budget, the EPA, and;other
agencies endorsed the legislation. Even some of the states
had become vocal advocates for the law which would shift to
the federal government many of the politically charged
problems of public health threats that they were encountering
every day. Since no one seemed to object, any need for the
President to be concerned with the fine print must have
appeared very unimportant in comparison with the large
issues of the reelection campaign. In any event, the President
clearly missed a useful opportunity to enhance his image as
a responsible advocate of environmental protection by not
taking center stage in the rose garden.
TSCA Perspectives
_ P-2
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issue No. 4 (Supplement)
Perspectives on TSCA
Looking Back: Twenty Years Later
Marilyn C. Bracken, Ph.D., Bracken Associates, L.L.C. (Deputy Assistant Administrator for Toxics
Integration, Office of Toxic^Substances, 1980-1983)
When I reminisce about the early days of TSCA, L am
reminded of the youth and enthusiasm of the staff and the
challenges of implementing ,a new law. In my case, some
particular challenges were organizing and publishing the
Inventory of Chemicals, writing Section 8 rules, working with
member countries of the Organization for • Economic
Cooperation and Development on .international activities in
chemicals, and using the integration authorities of TSCA to
coordinate and disseminate information: We were pushing
"technology trying to get computers to talk to each other.
'Twenty years later, we can all log on to the Internet and find
information on chemicals, their uses, exposure data, product
data, test data, etc. — much of it a byproduct of the^
information collection and dissemination statutory authority
' of TSCA.
A real benefit of TSCA was dausing a change hi the way
companies organize" and track information on chemicals.
Now companies routinely track exposure, seek ways to
prevent releases and negative impacts to human health and
the environment, and concern themselves with product
stewardship.* -There is a new awareness of quality
management,of chemicals that TSCA clearly impacted,
perhaps not as explicitly as the original implementers thought
but nevertheless a pervasive influence.
The TSCA Program Gathers Momentum
Don R. Clay, President, Don Clay Associates, Inc.
(Director, Office of Toxic Substances, 1981-1986),
From 1981 to 1986 — my tenure as head of the Office of
Toxic Substances — were exciting and productive years/ We
established the new" chemical review program without bringing
the American chemical industry to its knees, the .first
Premanufacture Notice (PMN) exemption for polymers was
developed, and the great debate within the Organization for
Economic- Cooperation and Development over the use of
structure activity versus using a base "set of data was raging.
Section 4 testing rules were being developed at a rapid rate
and the existing chemicals program was struggling to^regulate
asbestos." Rules were being written for polychlorinated
biphenyls (PCBs), and'a lot of time was spent deciding
whether or not formaldehyde is a,4 (f) chemical. (OTS later
determined mat formaldehyde is a 4(f) chemical.)
Unlike many of EPA's offices, the TSGA Office had the
luxury of being able to devote some resources to looking
ahead, rather than being driven exclusively by deadlines
imposed by statute or court order. As a result, we were able
to predict that biotechnology would become a growth
industry and that, at least initially, we would need some level
of review to assure,, the public that these living products
would not harm ttiem. Thus was ,bom a series of
biotechnology regulations, a program that continues to this -
day. - .'„ „ - -
The TSCA Chemical Inventory
Bob Hagerman (RegulatoryAssociate, Dow^Chemical, 1955-1995)
A review of the Toxic Substances Control Act upon its
enactment twenty years ago demonstrated that it provided the
EPA powerful, perhaps unique, authority to gather from
manufacturers, processors, and users of chemicals data:
needed to evaluate and regulate risks associated with industry-
products and activities.
The first application of this authority was the development of
the TSCA Chemical Inventory reporting rule as required by
Section 8(b) of the Act. A small subgroup of the Chemical
Manufacturers Association (CMA) Chemical Regulations
Action Committee (then MCA-CRAC) met with its EPA
counterparts over an extended period to determine what -
'information would be both useful and practicably obtainable
for the. purpose of compiling a list of chemicals in U.S.
commerce: This was a pioneering effort because neither side
had experience with a law such as TSCA and many of those
involved at the time had no experience with the regulatory
process. '
TSCA Perspectives
_ P-3 .
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Chemicals in the Environment
FalM 996
Initially the effort was aimed at developing a simple list of
chemicals in US commerce. This was complicated following
proposal when, on a brigh» Jkinday morning on May 1977,
Administrator Charles Quarles appeared on "Meet The
Press." Chagrined by lack of an answer when asked how he
hoped to regulate chemical risks without knowing where they
were produced, by whom and hi what quantity, Mr. Quarles
vowed to rectify the situation.
Very shortly we were involved in a drastically revised
proposal. In addition to this pivotal issue, in always lively
and frequently spirited discussions we addressed other major
issues including: What information could be treated as
confidential business information? How should quantitative
production data be reported and revealed to the public? How
should polymers be identified? How should process
intermediates be treated? What about chemicals used for
research and development? :
The process illuminated the perspectives of all interested
parties and led, I believe, to a regulation which served at least
the essential needs of each. In addition, the effort provided
a model for cooperation between industry and EPA in
regulation development.
TSCA Consent Order Process for Testing
Robert M. Sussman, Latham & Watkins (Deputy Administrator, EPA, 1993-1994)
An important milestone in the history of TSCA was the
development of a framework for enforceable consent orders
requiring testing on existing chemicals. This framework has
not been a panacea for all of the shortcomings of the TSCA
testing program but it has provided a useful and often
effective technique for initiating testing that supplements the
rulemaking process established in the statute itself.
In its early years, the TSCA testing program proceeded in fits
and starts. EPA was slow to develop proposed test rules, in
part due to uncertainties about its statutory authority, and the
first groups of testing recommendations issued by the
Interagency Testing Committee (ITC) languished without
follow-up action by the Agency. (See related article about
the ITC in CIE, no. 4.)
The Natural Resources Defense Council (NRDC)
successfully sued EPA in 1980 to compel the Agency to
address ITC-designated chemicals within twelve months
either by proposing a test rule or by determining that
rulemaking was unnecessary. With the support of the
chemical industry, EPA began entering into voluntary testing
agreements responsive to data needs on several ITC-
designated substances. However, NRDC filed suit again,
arguing that these agreements could not substitute for test
rules because they were not enforceable and had not been
developed through notice-and-comment rulemaking.
After NRDC once more prevailed in the courts in 1984,
CMA approached EPA and NRDC representatives to explore
developing a legally acceptable process that would
preserve the benefits of negotiated agreements, including
the opportunity for early technical dialogue between
knowledgeable experts and the ability to minimize delay and
controversy hi launching needed testing. All perceived the
value of a cost-effective alternative to the TSCA rulemaking
process, and productive discussions were soon underway
which led to agreement on a new system of negotiated
consent orders under Section 4. The hallmarks of this
system, which were reflected in a procedural ;rule EPA
published in 1986, were a transparent negotiation process
accessible to the public, a strict timetable for developing a
consent order or proceeding with rulemaking, and
enforceability of consent orders on the same basis as test
rules. Simultaneously, the consent order system enabled
EPA to conserve resources by eliminating the need to
develop and support the findings required for test rules as
well as the administrative burdens created by the notice-and-
comment process. « :v
The consent order process has shown impressive staying
power: EPA has used it for about fifty chemicals over a ten
year period. At the same time, EPA has continued to use
rulemaking where it seeks testing that is complex or
controversial. r " .,,---"
The Section 4 testing program is not without critics; many
observers remain disappointed with the pace and scope of
EPA's testing activities while others argue that EPA on
occasion seeks unnecessarily extensive testing. There is little
argument, however, that the availability of consent orders has
enhanced the effectiveness of Section 4 — demonstrating the
wisdom of CMA, NRDC, and EPA in working together to
create an alternative to formal rulemaking ten years ago.
TSCA Perspectives
P-4 .
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Issue 4
TSCA Today
Risk Management (continued)
coerce private sector behavior by regulatory
edict. The emphasis gradually shifted from
adversarial confrontation to negotiated and
voluntary agreements, and to cooperative efforts
to find solutions to toxic chemical problems.
TSCA Section 6 is now viewed as an option to be
used only when private sector cooperation is
lacking, and where there are no other suitable
regulatory authorities.
Cgm-sit Operations
While-" regulation remains an option when
circumstances so dictate, management of existing
chemical problems today more frequently
employs suasive approaches involving
dissemination of information, participation by all
factions, and multi-party negotiations to arrive at
consensual and effective solutions. Typical
specific strategies are highlighted below.
Assisting other public sector officials - OPPT
provides technical and analytical expertise to
Regional, State, and local entities to support their
counterparts' efforts to reduce toxic chemical
risks. In a typical example, OPPT's assessment
of a serious and continuing toxic chemical
exposure in Hammond, Indiana enabled Region 5
and the State authorities to initiate actions that
virtually eliminated that risk.
Preventing pollution - In recent years, the Office
has undertaken several projects that have
prevented pollution by: (1) identifying safer
substitutes for toxic chemicals used in commerce
and encouraging their use; (2) compelling
removal of toxic chemicals from commercial use,
often within the context of potential regulation;
and (3) providing technical assistance to
industries in developing ways to eliminate or
reduce emissions of injurious chemicals into the
surrounding environment.
Empowering communities - Under the authority
of the Emergency Planning and Community Right
to Know Act, OPPT collects annual data on the
location and amounts of toxic chemicals released
to the environment by industrial facilities. The
Office has now begun disseminating analyses of
these industrial emissions, to communities
identified as having excessive loadings, as a
means of enabling citizenry to resolve problems at
the local level.
Utilizing assessments - In order meet its
regulatory responsibilities, a substantial fraction
of OPPT's resources are devoted to identifying
and assessing risks po'sed by specific toxic
chemicals. These assessments, which may require
two or more years to complete, almost always
entail intensive involvement with the relevant
industries to obtain and interpret the necessary
information. While these assessments generally
conclude that the identified risks do not warrant
regulation, they also typically find that the risks
are nevertheless not insubstantial. In these
circumstances, the Office has now started using
the completed assessments to exhort
manufacturers, processors and commercial users
of the chemicals to voluntarily find ways to
reduce the attendant risks. As a further
inducement to action, the assessments are often
publicized.
Generating consensus - To ensure that issues are
examined from the broadest perspective, all
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Chemicals in the Environment
Fall 1996
Risk Management (continued)
potentially affected parties are brought togethei
at the outset of every OPPT regulatory
assessment, and their collective involvement is
encouraged throughout the investigation. The
Office has found that the very process of
developing a common understanding of issues
goes a long way toward achieving consensus
regarding solutions. In these instances, industry
will often voluntarily undertake remedial actions
that would have taken far more time and effort to
achieve by regulation. More importantly, ths*
interactive process generates cohesive :^
mutually respectful relationships that stand in
stark contrast to the divisive bitterness that often
accompanies rulemaking.
Establishing accountability - Most contemporary
industries and trade associations have voluntarily
developed and adopted Codes of Conduct or
Product Stewardship programs that stipulate,
among other things, how member companies
should handle toxic chemical problems prevalent
in their respective areas. OPPT is now beginning
to determine how well individual companies live
up to these standards, and to give public
recognition, both to those that excel and to those
that fall below par.
Interagency Committee Improves Cooperation
Matt Gillen, Environmental Assistance Division
Section 9 of TSCA describes the relationship
between TSCA and other Federal laws. Under
this section, if EPA finds that a toxic chemical
poses an "unreasonable risk" that could be
reduced by an action taken by
another agency, then EPA can file
a request to the other agency to
take action. Section 9 also calls
for EPA to consult and coordinate
with other agencies. Because
toxic chemical risks can affect
consumers and workers, EPA
coordinates with other agencies
that have primary authority for
protecting these groups.
Employees working directly with
chemicals typically have greater
opportunity for exposure in
comparison to members of the
public, so this is an area of special
concern. EPA chemical screening
activities often lead to questions or concerns
about the possibility or need for reducing
occupational exposures.
In order
to improve coordination among Federal
agencies on worker
toxics issues, EPA
entered into a
memorandum of
understanding with two
other occupational
agencies in 1987. The
agencies were the
Occupational Safety
and Health
Administration
(OSHA), which is part
of the Department of
Labor, and the National
Institute for
Occupational Safety
and Health (NIOSH),
which is part of the Department of Health and
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Issue 4
TSCA Today
Interagency Committee (continued)
Human Services.
The agreement
created a standing
committee, called
the ONE (QSHA,
MIOSH, EPA)
Committee, to
provide a forum for
agency managers to
discuss worker
toxics issues. In 1990, the Mine Safety and
Health Administration (MSHA).,also from the
Department of Labor, was added. (The acronym
ONE was retained.)
The ONE Committee has provided a useful
vehicle for the agencies to learn more about each
other's authorities, projects, and priorities. Each
agency has different, although related,
responsibilities and objectives for addressing
worker toxics issues. OSHA and MSHA have the
lead role for risk reduction and regulation of
existing chemicals. NIOSH has the lead role on
research and on tracking the rates of work-related
disease. EPA has the lead role for regulation of
workplace risks in two areas: new chemicals
(under TSCA) and field worker exposure to
pesticides (under other laws). EPA also has the
lead role for testing and collecting information on
existing chemicals.
The ONE Committee meets monthly to discuss
ongoing activities, to initiate joint efforts where
appropriate, to avoid potential duplication of
effort, and to plan collaborative projects. Two
examples illustrate how the agencies can work
together:
> Skin permeation testing - There are many
substances without any data as to whether
or not they can penetrate the skin. This
important information can be taken into
account when establishing workplace
exposure standards. OSHA does not
;,, have the authority to require testing, but
EPA does. The agencies &io working
together, with EPA using its testing
authority to require chemical
manufacturers to perform tests for 80
chemicals so that OSHA can use the
results to inform employers and adjust
their workplace standards.
> Metalworking Fluids - OSHA, NIOSH,
and EPA are working together with
industry and labor stakeholders to
•. ;. identify, evaluate, and remittee-risks from
exposures to these materials. They are
used by large numbers of workers during
metal machining operations. NIOSH
pulled together the available information
and performed-an initial review of the
issues, and OSHA will convene
stakeholders to further evaluate the risks
and to recommend approaches for risk
reduction so that regulations can be
developed. EPA is coordinating with
both agencies so that data gaps found to
pose an obstacle to risk reduction can be
filled using TSCA testing tools.
In summary, our national laws divide up the
various roles to be played on worker toxics issues
to different agencies. The ONE Committee is the
forum by which these agencies coordinate and
collaborate to help insure that a comprehensive
approach can be taken where appropriate.
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CJiemicals in the Environment
Fall 1996
Section 21 Petitions Highlight Citizens' Concerns
Michelle Price, Environmental Assistance Division
Section 21 of TSCA provides that any person may petition
EPA to initiate proceedings for the issuance of rules under
Sections 4, 6, and 8 of TSCA. Such a petition must set
forth the facts which the petitioner believes establish the
need for the rules requested. EPA is required to grant or
deny the petition within 90 days. If EPA grants the
petition, the Agency must promptly commence an
appropriate proceeding. If EPA denies the petition, the
Agency must publish its reasons in the Federal Register.
Since the creation of TSCA, EPA has received
approximatery 60 TSCA Section 21 petitions from states,
trade associations, environmental groups, individual
citizens, businesses, public interest groups, and unions.
They have covered a wide range of issues, from
polychlorinated biphenyls (PCBs) and asbestos to
requesting actions on various individual chemicals.
' One well-publicized action under Section 21 recently
culminated in a report entitled, "Summary of Information
Collected from U.S. Parent Companies of Maquiladoras
Relating to the New River." (Maquiladora is the
Mexican term for a foreign-owned factory operating in
Mexico that uses local labor to manufacture goods for
export) The report followed investigation into three
Section 21 petitions from citizens living in the vicinity of
New River who expressed concern about the river's
pollution and potential threats to health and the
environment
Publication of this report in February 1996 marked the
end of information gathering efforts begun in 1994 in
response to the New River petitions. It describes EPA's
information collection efforts and the pollution of New
River. It also summarizes information collected from
U.S. parent companies of maquiladoras with facilities in
Mexicali, Mexico in the vicinity of the New River. This
information was provided to EPA in response to both
EPA's April 1994 letter and subpoenas issued under the
authority of Section 11 of TSCA. It was collected to
determine whether these subsidiaries manufacture,
process, or otherwise use, import, export, or dispose of
chemicals that could be contributing to industrial
contamination of the New River.
In the case of New River, EPA denied the initial petition,
and the two subsequent petitions were withdrawn by the
petitioners based on actions taken by EPA to address the
issues raised in the petitions.
Based on the releases reported by U.S. parent companies
of 83 maquiladoras, they do not appear to be major
contributors to industrial pollution in the New River.
However, the information contained in the responses from
the U.S. parent companies was insufficient to permit EPA
to independently assess whether the data are
representative of the actual releases of industrial pollutants
from the maquiladoras. Further, EPA does not currently
possess the data necessary to make such a determination
and believes that the continued monitoring of the New
River is the most effective way to provide accurate
information on the pollutants in the river.
Even though the petitions were denied in this instance,
EPA's actions under Section 21 of TSCA have clearly
increased the community's knowledge about sources of
pollution of the New River.
For information on other TSCA Section 21 petitions and
their disposition, contact the TSCA Non-Confidential
Information Center at (202) 260-7099.
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Issue 4
TSCA Today
Evolution of CB! Policy under TSCA
Scott Sherlock, Information Management Division
"I think the essential element of this
legislation is that it has attempted to provide
the individual - not only who works, but for
the rest of society - the right to know what is
in store as far as the toxicity of chemicals is
concerned." Senator Pearson, Legislative
History of the Toxic Substances Control Act
(1976) Chapter 2, S.3149, Senate debate,
218.
"(T)he Committee recognizes that some
information which the Administrator may
obtain will be of tremendous competitive
advantage to the person providing it.
Accordingly, section 14 contains specific
prohibitions against release of such
information so that the competitive
position of those supplying information
will be protected." Committee
Report, Legislative History of the
Toxic Substances Control Act
(1976) Chapter 3, H.R. 14032, 457.
These two comments succinctly summarize the
competing interests for EPA in implementing TSCA:
right-to-know versus the obligation to protect
proprietary data. Since 1976, we have struggled to
find a balance between these interests.
In its effort to achieve balance, EPA was hampered
because it operated in essentially uncharted territory.
TSCA was the first statute that allowed the Agency
to address the risks of toxic chemicals from cradle to
grave. TSCA gives EPA the authority to manage
substances from the research and development stage,
to manufacturing, use and, finally, disposal. In order
to adequately address its obligations under TSCA,
EPA required the regulated community to direct an
unprecedented amount of sensitive, confidential data
to the Agency.
One important initiative, little remembered now, was
the effort to secure the confidence of industry that
the we could protect this sensitive information.
Securing that confidence was an absolute
precondition to successful implementation of the
statute. Keeping that trust is an ongoing
responsibility.
The second critical initiative, which
continues today, is addressing EPA's
statutory obligation to advise the public
on the risks of chemicals in commerce.
This issue of keeping the public
apprised and ensuring opportunities
for public participation in
chemical management
proceedings under TSCA has
always been a cornerstone of the
Federal toxics program. It has
become even more important
since 1986 when the Emergency
Planning and Community Right-to-Know Act
was passed. This Act called for creation and
dissemination of the Toxics Release Inventory (TRI).
With the successful implementation of TRI, the
Agency recognized the tremendous power given the
public by requiring chemical manufacturers and
processors to provide to the public basic information
on chemicals released into the environment. As a
result, the public became an indispensable party in
environmental protection and a powerful force in
reducing releases of toxic substances into the
environment.
EPA has struggled to fulfill the right-to-know
component of TSCA. In 1994, it devised a
multifaceted strategy to reduce inappropriate CBI
claims and to increase the availability of TSCA data
to the public yet maintain our traditional vigilance to
protect genuine CBI. Efforts have included:
=23=
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Chemicals in the Environment
Fall 1996
Evolution of CBI (continued)
Educational Programs: Cooperative efforts with
industry to advise the regulated community of what
may and may not be claimed as confidential.
TSCA Information Products: By increasing
availability of TSCA products, OPPT increases the
public's interest in TSCA data.
State Programs: States are a natural constituency
for TSCA information and OPPT information
products. Fpsteiing and building this constituency of
state chemical managers encourages the regulated
community to reduce inappropriate CBI claims.
Sculpted Regulations: Since 1994, the Agency has
proposed a number of regulations that were carefully
crafted to limit burden but which ensure that CBI
claims are well thought out and limited to only that
information which is sensitive and must be claimed as
confidential.
These programs have succeeded in limiting some
inappropriate CBI claims. We fully recognize,
however, that what has been achieved so far is not
enough. While EPA recognizes the absolute need to
protect CBI information in a manner consistent with
the statute, the Agency needs to continue to address
its obligation to make information on toxic chemicals
available to the public. To this end, EPA is strongly
considering additional voluntary and regulatory
initiatives which will reduce unnecessary CBI claims
for plant site identities and for ensuring "retirement"
of older CBI claims.
TSCA as a Tool for Integrated Environmental Management
Cindy Foumier, Chemical Management Division
A major purpose of TSCA was to fill gaps left by other
media-specific environmental statutes. For example, in
the absence of TSCA, regulations limiting the air
emissions of a toxic chemical could result in increased
water emissions of that chemical. Now, however, EPA
can consider and manage total human or environmental
exposure of a chemical, by using TSCA authority to
regulate all aspects of the manufacture, processing,
distribution, use and disposal of toxic chemical
substances. If the EPA Administrator determines that
any of these activities pose an unreasonable risk to
health or the environment, Section 6 of TSCA contains
a number of risk management tools that EPA may use.
These tools include:
• bans or limits on manufacturing, processing, or
distribution
• labeling requirements for products
• recordkeeping requirements for manufacturers
and processors
• bans or limits on commercial uses
• specific disposal requirements
hazard communica-
tion requirements
for manufacturers
and processors
Before a TSCA Section 6 rule
can be issued, EPA must consider
health effects, environmental effects, magnitude of
exposure, the benefits of the substance, the availability
of substitutes for the substance, and the effect that such
a rule will have on the economy. EPA is also required
to choose the least burdensome regulatory tool that
will adequately address the risks of a substance.
Because Congress was so concerned about the health
and environmental effects of polychlorinated biphenyls
(PCBs), a specific ban on the manufacture, processing,
distribution, and use of PCBs was incorporated
intoTSCA Section 6. PCBs were manufactured as a
fire-resistant insulating fluid for electrical equipment.
They are potential carcinogens that can also cause skin
disorders and adversely affect reproduction and
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Issue 4
TSCA Today
TSCA as a Tool (continued)
development. In the environment, PCBs are toxic to
fish and impair reproduction in mammals and birds.
The PCB regulations cover the marking of PCB
transformers and other electrical equipment that are
still in use, clean up of spills, procedures to be followed
in the event of a PCB transformer fires, and disposal
methods.
Another example of comprehensive regulations that
address a single chemical involves asbestos. Asbestos,
which is a naturally-occurring fibrous mineral, has been
extensively used in thermal insulation, fireproofing, and
acoustical applications. Inhalation of asbestos fibers
can cause lung and other cancers, as well as asbestosis,
or "white lung." The emission of
asbestos fibers has been regulated by
the Clean Air Act since 1973.
However, these regulations are
intended to safeguard air quality in
general, rather than protect workers
and other building occupants. To address
these risks in schools, EPA used the authority
of TSCA Section 6 to regulate asbestos-
containing materials in school buildings. This
1982 rule required primary and secondary
schools to inspect their buildings for the types of
asbestos that are most likely to release fibers into
the air. In 1986, Congress superseded the old
asbestos-in-schools rule with the Asbestos Hazard
Emergency Response Act, which required schools to
conduct thorough inspections, prepare asbestos
management plans, and respond appropriately to
asbestos hazards present in their buildings. Also in
1986, EPA issued a regulation to protect the health of
state and local government employees who perform
asbestos removals and who are not otherwise
coveredby OSHA or an OSHA-approved state plan.
Although the asbestos-in-schools and worker
protection rules covered serious gaps in the regulations
under the Clean Air Act and the OSHA standards, they
did nothing to prevent future health risks caused by
manufacturing, processing, use, and disposal of
asbestos-containing materials. In 1989, EPA issued the
Asbestos Ban and Phaseoui Rule, which banned, in
stages, most of the common uses of asbestos. Nearly
all aspects of this regulation were overturned by the
Fifth Circuit Court of Appeals in 1991. The Court's
decision shows how important it is for EPA to fully
consider all of the factors required by TSCA § 6, such
as economic effects and the availability of substitutes.
According to the Court, EPA had not demonstrated
that the Asbestos Ban and Phaseout Rule was the least
burdensome regulation that would address the risks.
Also, the Court was concerned that EPA had not
adequately explored the effects on mqtoi; vehicle safety
that could result from requiring automobile
7 manufacturers to substitute other materials for
• asbestos in brake linings.
_ J^ EPA has also used TSCA
flp n ^Jy Section 6 to reduce
environmental risk!* from
chlorofluorocarbons (CFCs),
which adversely affect the
earth's ozone layer. In March 1978,
EPA banned the manufacture and
processing of CFCs for use as aerosol
propellants and required annual reports
from manufacturers and processors on
CFCs for these uses. Before TSCA, there
was no effective way to regulate CFC
propellant emissions, because CFCs are not air
pollutants in the traditional sense. They are not
considered poisonous and pose no risk to workers.
This rule is a good example of how TSCA § 6 can be
used to control chemical hazards where other
environmental laws cannot.
The broad scope of TSCA § 6 means that actions taken
under its authority can have severe consequences on
the economy and other factors. This explains why EPA
has been so careful in regulating chemicals under this
provisioa In addition to the three chemicals described
above, EPA has used TSCA § 6 to issue regulations
covering two other situations, the disposal of dioxin-
contaminated waste and the use of hexavalent
chromium in comfort cooling towers. EPA also has
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Chemicals in the Environment
Fall 1996
TSCA as a Tool (continued)
published proposed rules to limit acrylamide in
grouting materials and lead and zinc in fishing sinkers.
While it has been argued that the Court's ruling on the
Asbestos Ban and Phaseout Rule may dissuade EPA
from taking future actions under this section of TSCA,
it has more likely provided us with valuable lessons in
using this powerful tool to protect human health and
the environment.
CAS Numbers: Unique Identifiers for Chemicals
Doug Sellers, Information Management Division
Under TSCA, OPPT collects a wide variety of
information on chemicals. These various information
collections are described elsewhere in this publication.
However, with tens of thousands of chemicals on
the Inventory, including classes of
closely-related chemicals, one
critical question that must
always be answered is, "How
can we be sure we are
referring to precisely the
same chemical
substance?" OPPT
does this by relying on
the Chemical Abstract
Service (CAS)
Registry Numbers.
CAS numbers are
assigned by the
Chemical Abstracts
Service to identify
unique chemical
substances. Even different
forms of the same chemical
structure will have a unique CAS
number. OPPT needs this kind of
identification because of the uncertainty
of chemical names. There can be different names for
a single chemical. Some generic names cover several
substances. On the other hand, chemical names can be
very specific and complicated, describing the location
and attachment of every atom in the structure. What
Methyl IsobutylKeto
this means is that chemical names are not a useful and
convenient method of specifically identifying a given
chemical substance.Precise chemical nomenclature is
very important in OPPT's chemical information
activities. The original chemical inventory
collected under TSCA in 1977 was
based on CAS numbers. (See Lau
article this issue). CAS
numbers provide more precise
definition for the regulated
community, to assure that
OPPT requests and they
provide information on
the exact chemical
needed. Chemical
assessments and studies
rely on correct
chemical identification.
OPPT uses CAS
numbers to clearly
dentify chemicals in its
public databases and
information products.
numbers are easy to locate.
re frequently included on
product labels. Additionally, there are both
printed and computer-based systems available in your
local library that confirm CAS numbers. Including the
CAS number in a request for information will ensure
that OPPT provides you with the information that you
are seeking.
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Issue 4
TSCA Today
Changes in Information Technology under TSCA
Information Collection
Nancy Vogel, Information Management Division
Advances in information technology are underway in
the TSCA docket. The Agency workgroup focusing o n
docket issues is encouraging regulation developers to
submit large support documents (such as meeting
transcripts) to the docket in electronic (diskette)
format, as well as on paper. In addition, we are
working with the Office's Federal Register staff to
begin uploading docket indices to the Internet. OPPT
is also experimenting with ways to facilitate the
electronic submission of public comments (on rules,
policies, etc.) to the dockets.
In 1994, OPPTS began accepting comments
electronically on the proposed biotechnology rule and
the lead SNUR. (SNUR means Significant New Use
Rule, which may be issued by EPA when a company
identifies a new way of using an "^^K' exis
ting chemical.) Beginning in 1995, as ^^^ a
result of these and other pilot projects throug
hout the Agency, Federal Register notices for all TSCA
rulemaking actions contained instructions for how the
public could submit commentsand data electronically.
Submissions containing no TSCA confidential busifless.
information, in ASCII or WordPerfect format, may
now be sent via electronic mail to
OPPT.NCIC@EPAMAIL.EPA.GOV. EPA transfers all
comments received electronically into hard copy
format as they are received. These paper copies are
placed in the official record, which also includes all
comments submitted directly in writing. These efforts
should conserve resources as well as increase the speed
and accuracy of handling.
Information Dissemination - Past and Present
Doris Bloch, Information Management Division
At the inception of TSCA and for some years
thereafter, EPA's information dissemination
practices could be summed up by two types of
outputs: copies of paper documents and products
from large, mainframe systems.
EPA received all information either in paper format
or, a small percentage, on computer-readable tapes
formatted for mainframe use. The same was true for
dissemination: the majority of information was sent
out as paper, in some cases reports extracted from
mainframe systems, or on tapes.
For instance, EPA published the
TSCA Inventory in two
formats; a five-volume book
available from the Government
Printing Office and computer
tapes available for purchase from
the National Technical Information Service. Other
major distribution channels were individual
responses to written Freedom Of Information Act
(FOIA) requests and external onlinedatabase
providers such as the Chemical Information System.
(FOIA responses, especially, involved only small
parts of larger data bases or document collections.)
Only in recent years has EPA used other options for
sharing information with a wider public. For
example, EPA publishes data for chemicals on the
TSCA Inventory, Notices of Substantial Risk
submitted by industry under Section 8(e), and other
data bases on diskettes and CD-ROM; we distribute
the TSCA Test Submissions data base containing
various studies, test results and notices on
microfiche.
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Chemicals in the Environment
Fall 1996
Dissemination (continued)
More recently, EPA has begun publishing a wide
variety of document files on EPA's Internet home
page. This change is largely due to the
proliferation of desktop computing in so many
offices and homes and the expectation that large
numbers of people can use information in an
electronic format.
We also realize that the extent of the data
received under TSCA could be unmanageable and
,, overwhelming without an electronic mechanism
jfc»-organize it and assist those who are interested
in finding relevant information quickly and
effectively.
TSCA data are no longer exclusively mainframe-
based, as that approach was recognized to be too
restrictive. While OPPT is moving to an
electronic environment, the Office recognizes that
the change will not occur immediately, either
internally or externally. And some of our public
clients and customers will prefer to receive paper
copies, even after internal systems are automated.
Paper-based dissemination through FOIA, the
docket, and the TSCA Hotline and for Federal
Register notices will remain as a distribution
option inherited from the past and projected to
continue far into the foreseeable future.
New Chemicals Program Embodies Pollution Prevention
Roy Seidenstein, Chemical Control Division
The Pollution Prevention Act of 1990 ranks the
preferability of general methods of controlling
chemical risks as follows: source reduction,
recycling, treatment, and disposal. The rationale
for this ranking is that it is usually better,
environmentally and economically, to
avoid creation of a pollutant than to
subsequently control exposures and
releases which often results in shifting
a pollutant among environmental
media (i.e., land, air, water).
EPA's New Chemicals Program,
mandated under Section 5 of
TSCA, plays an important role in
preventing pollution. Section 5
authorizes EPA to review new
chemicals before they enter the
market for the risks they may pose
to human health and the
environment. This statutory authority, enacted in
1976 and covering chemicals from cradle to grave
and across all environmental media, embodies the
modem pollution prevention paradigm.
Since the New
Chemicals Program
started in 1979, EPA
has reviewed almost
30,000 new chemicals.
In approximately 2,000
cases, EPA took
regulatory action to
prevent pollution or
risks to human health
that otherwise might
have resulted from the
manufacture, process,
use and disposal of
these chemicals.
.28.
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Issue 4
TSCA Tomorrow
Pollution Prevention (continued)
Under the New Chemicals Program, anyone who
plans to manufacture or import a new chemical
substance must provide EPA with a
premanufacture notice (PMN) at least 90 days
prior to commencing such manufacture or import.
To determine whether a substance is "new," the
company must consult EPA's Inventory of
Chemical Substances (commonly known as the ,
TSCA Inventory). If the substance is not listed on
the TSCA Inventory, it is a "new" chemical.
EPA scientists from various disciplines
work together to predict the
potential risk to humans and the
environment from each new
substance. The evaluation uses
data submitted on or with the
PMN form, other
information available to
EPA, and exposure and
release modeling. Since
EPA revised the PMN form
in 1991, it has contained a
page encouraging
companies to provide
information telling EPA about
any pollution prevention
advantages of the new chemical.
After reviewing the PMN, EPA may take
a variety, or a combination, of actions:
(1) If EPA determines that a new chemical may
pose an unreasonable risk, EPA can enter into a
consent order permitting the company to
manufacture or import the new substance under
restricted conditions intended to control exposure
and releases of the substance. The consent order
may require a Pollution Prevention Plan for the
chemical either before production begins or when
a certain production volume is reached.
(2) Besides regulating risky new chemicals,
EPA has begun sending letters to certain PMN
submitters recognizing selected new chemicals
that may constitute safer substitutes or be
developed via pollution prevention processes.
Only about half of all chemicals that go through
the PMN process ever go into production, which
makes such encouragement all the more
important. Criteria include actual test data on the
PMN substance itself, less toxicity associated
with the new chemical or related chemicals,
reduced exposures and releases, conservation of
energy and water and environmentally beneficial
uses. The letter to -the
manufacturer of such a
chemical notes their
contribution to preventing
pollution. It also asks
the company to inform
EPA of the
commercial success
of the product over
time, and of any new
toxicity and
exposure data that
become available.
(3) Whether or not
EPA decides to regulate a
PMN substance, EPA may
suggest the use of "green
chemistry" to help the company
identify alternate synthetic pathways that
will help reduce toxicity and pollution in the
production of the chemical.
Additionally, as an exemption from the PMN
requirement, EPA has promulgated a new Low
Exposure/Low Release Exemption Rule that
provides an abbreviated 30-day review period for
substances that meet specified criteria for
negligible exposures and releases.
For more information on pollution
prevention in the New Chemicals Program,
contact Roy Seidenstein at 202/260-2252.
.29.
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Chemicals in the Environment
Fall 1996
Emerging Right-to-Know Themes Under TSCA
Steve Newburg-Rinn, Information Management Division
From its inception, TSCA addressed regulatory
control as well as information gathering. Some
sections of TSCA (for example, Sections "4 and 5,
which provide for chemical tesjEmgjatid approval
of new chemicals) seelTto g^M^iiifermation,
albeit through regulatory means: "Sections 6 and
•*4
r
In contrast, the intent of Sectioa & off SCA was
rf ^M IT^""* j * w> *
clearly informgtioa gathering. v (Section &
addresses a variety olf activities, inefsding record-
keeping by rndustr&jareatlon of Ifae Inventory,
and submission of^h|alth pad safety studies to
EPA.) Section l^JcoficWoiag^ exports, was
information dissemination, r
The Agency, and we |'& individ\Ms.J ^
the more direct approach; of regulatory control
Staff would study a situation, marshal their fact
and build a record^arkl ultimately" tfee Agenc
would impose sp^Bic ijeqEarements on tl
industry sector beitig examidiei But regulatioi
were not nearly as'cjean aad aeaf 3$ we had|
anticipated. Toxico^gJistsexamlBiag compounds^
would often disa^^on*Jb^d.egree of risk thejj
posed. Our procedures leelme drawa out anc
lengthy. Whett EPA'washable'to fiaafis"
regulations, it founEitself sub^cf'to what seeme
to be an endless round of litigation. The result
was that the hoped-for changes were delayed,
and the risks continued.
During TSCA's infancy, we began to realize that
regulatory approaches, while important, were not
necessarily the only way to achieve good public
policy and risk reduction. As early as 1979, the
Office began experimenting with negotiation
among EPA and industry scientists to define the
testing needs for particular chemicals. While
subject to occasional litigation and adjustment,
this basic approach has continued to this day.
The public policy objective of the program was to
obtain all the testing data that was needed on
chemicals ta questioil «s expeditiously and cost-
effectively as posses.* then to assess the results.
EPA also makes the re&uits pubic Should the
findings be adverse, the testing information
collected woul& jjrobably sttve to change
behavior .long befi?^EP4 y^atd be able to
develop a new^omnaafld-atia** oatrol regulation.
The initial TSCA Inventory; a»d its successors
have given EPA staff aftd'fke piblic a better
understanding of the chemicals, in commerce and
^where tiiey might tie retasBiifaetured. The
ublished health ami safety todies collected
jder Sectioa ) O* T^SCA have proven quite
ifetors and researchers alike, as
Icolar chemicals Substantial risk
tiees received oifcler Section 8(e) have long
: used to directly aad immediately influence
aorafe behavior through the Office's active
gemination «f the iafonaalian they contain.
5 Office also issued Letters of Concern under
existing cfceffiieafe program as another
tive, tdiere a legaktor^ abroach might
|e too loag ot otherwise be inappropriate.
the Office evolved, these information
and dissemination activities were still at
the periphery of our conceptualization of our role,
until the passage and implementation of the
Emergency Planning and Community Right-to-
Know Act of 1986. The Toxics Release
Inventory (TRI), with its requirement for the
active public dissemination of information without
being filtered through EPA as regulator,
fundamentally changed the Agency's
understanding of the various arrows in its quiver.
Premanufacture review and regulation of
hazardous chemicals under Sections 5 and 6 of
-------
Issue 4
TSCA Tomorrow
Emerging RTK Issues (continued) *
TSCA are
no less
important
than they
ever were,
and they
remain an
essential
underpinni
ng of any
effort to
voluntarily
change behavior. But OPPT also came to realize
that information, by itself, could be a powerfiil
tool both to the public and to industry itself for
reducing risks from chemicals. When the CEOs
of large chemical companies suddenly were
confronted with their own: data showing that a lot
of valuable product was going up into the air
rather than being sold, they began to ask why.
They also asked their plant managers to do better.
The huge success of EPA's 33/50 program for
reducing releases of selected chemicals would not
have been possible without data collection to set
the initial baseline and as a measure of progress.
TRI provided the Office with a further tool in
examining the issues posed by chemicals which
might present risks. The Pollution Prevention Act
of 1990 added still more information which has
proven important as we seek pollution prevention
solutions. A significant part of programs such as
Design for the Environment or Green Chemistry
is the conceptualization that information and then
the technology transfer of better solutions will
yield important risk-reduction results. By
Executive Order, Federal facilities are now
required to comply with EPCRA.
As the Office enters its third decade, several
right-to-know initiatives are high on its list of
importance. Last year, the Office doubled the
number of chemicals covered by TRI to include
other chemicals of similar or greater toxicity as
those already in the TRI program. Secondly,
EPA has proposed that TRI be extended to
several industrial sectors (such as power
generation) that use the TRI chemicals and
account for a significant amount of toxics loading
to the environment. Once the regulatory process
to add these sectors is finished, expansion to
other sectors will be examined. The Office has
also proposed expanding the information
collected to include chemical use and materials
accounting tfajte.' These data additions will allow
more compreB'Sasive understanding of the roles of
chemicals in our lives, and they will provide
additional opportunities for pollution prevention
and risk reduction.
Finally, the Office has the lead for reinventing
how information is collected from the many
entities we regulate. We have proposed
collecting a common, consistent set of facility
identification information about each of those
700,000 or so entities. This would, in the long
term, allow elimination of duplicative reporting,
facilitate consolidation of collection of data from
those entities, and make public access to data
both easier and more meaningful. Thus,
information collection and right-to-know have
become important partners to regulatory
approaches for OPPT in fulfilling its mission.
-------
Chemicals in the Environment
Fall 1996
How OPPT Works with Outside Parties to implement and Gain
Compliance with TSCA
Ken Moss, Chemical Control Division
While OPPT's relationship with external constituent
groups has ebbed and flowed over the 20 years of
TSCA, there are many at EPA who have believed
that unless there is some healthy friction between
the Agency and its numerous public customers, we
are not doing our job correctly.
Times change, however, and EPA has increasingly
shifted to an approach of actively working to
engage our constituent groups. EPA now strives to
engage industry 0arge and small businesses), trade
associations, environmental groups, labor unions,
environmental justice groups, and others in the
general public in cooperative identification and
management of risks from exposures to industrial
chemicals. This improves our mutual understanding
of chemical exposures and risks and the needs and
perspectives of all our customers. We have done
this, for example, by exploring the relationship
between the chemical industry's Responsible Care
and EPA's TSCA chemical risk management
programs and by recognizing our common need for
information.
The Agency communicates its belief to industry and
the environmental community of the importance of
high quality toxiciry, use, and exposure
data for risk assessment to
permit a better
evaluation of
the health
o r
environmen
tal benefits
of new
products.
This helps
a 1 1
interested
parties to
better
understand comparative risk assessment and some
of the many choices to be made in the selection of
environmentally preferable products. Toxicity data
are valuable to the Agency as well as industry and
other external groups both for hazard identification
and to help design safer substitutes.
Meeting with the various constituent groups has
resulted in the identification of cross-cutting issues
and shared environmental concerns. We have found
that there is considerable power in pursuing the
many common environmental objectives in
partnership with these groups, rather than
unilaterally. The Office has hoped to build and
expand upon dialogue, trust, and cooperation,
using forums, public meetings, information
exchange, and product stewardship partnerships.
We have sought to empower the public with
knowledge of pollution prevention and sound
environmental management, EPA also strives to
provide assistance to chemical users and share tools
and risk management techniques with others in
efforts to address local environmental concerns.
OPPT now actively seeks partners within relevant
industry sectors to identify alternatives to the
traditional ways we have gone about
managing potential risks under
TSCA. This has
ushered in a new
generation of novel
approaches, such
as consent
agreements with
chemical
companies,
wherein the legal
requirements have
been scaled back
in response to
real, voluntary
.32.
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Issue 4
TSCA Tomorrow
How OPPT Works (continued)
steps taken by industry to foster skie handling of
their products by downstream users. We have
worked to include all levels of the market in formal
product stewardship partnerships between the
Agency, companies, and trade groups. Products of
these efforts have included the development of
product stewardship guides for select groups of
both new and existing chemicals, coordination of
risk reduction efforts with the; environmental
insurance industry, and working with chemical
manufacturers to establish fundaigi'the purchase of
personal protective equipment either technology
that would help smaller businesses afford the
equipment needed to reduce exposures in their
workplace.
As part of our overall effprts to encourage pollution
prevention and the development of safer chemicals
or cleaner industrial processes, OPPT continues to
engage the chemical industry in dialogue to discuss
issues or concerns, jointly develop focused testing
programs or novel risk management approaches,
implement product stewardship programs, and
encourage innovation in commercially promising
chemicals. The future is cooperative and lies in
finding solutions to common problems.
The Use of Environmental Chemical Databases in OPPT
Becky Jones, Health and Environmental Review Division
The introduction of chemical databases into OPPT's
workflow dramatically changed and streamlined the
chemical review and information dissemination
processes. OPPT developed a variety of computer
data bases to manage the information that is
submitted under various sections of TSCA. The
data bases are used to track the submission of
information, facilitate use of the information in
reviewing individual chemicals, look for similar
effects for related chemicals, and make the
information available to the public.
Computer programs have also been developed to
estimate physical/chemical properties of chemicals
(such as water solubility), to predict exposure to
wildlife and people from releases to the
environment, to determine what levels will be
harmful to plants and animals that Eve in water, and
to predict how likely a chemical is to cause cancer.
In the future, OPPT intends to combine many of
these data bases to further increase the efficiency of
the chemical review processes and provide easier
public access to the non-confidential information.
.33.
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NEED HELP FINDING OUT ABOUT TSCA?
CALL THE TSCA HOTLINE!
The TSCA Assistance Information Service provides up-to-date information and
assistance about programs implemented under the Toxic Substances Control Act
(TSCA), the Asbestos School Hazard Abatement Act (ASHAA), the Asbestos
Hazard Emergency Response Act (AHERA), the Asbestos School Hazard
Abatement Reauthorization Act (ASHARA), the Residential Lead-Based Paint
Hazard Reduction Act, and the Pollution Prevention Act (PPA).
The TSCA Hotline is staffed by professionals who are trained to answer technical
inquiries about TSCA, ASHAA, AHERA, ASHARA, the Lead-Based Paint Hazard
Reduction Act and some Pollution Prevention activities, including the 33/50
program.
The TSCA Hotline stocks a variety of documents, including Federal Register
notices, reports, informational brochures, and booklets. These are available free
of charge.
For more information or to request a document,
Call: (202)554-1404
TDD (202) 554-0551
Monday-Friday
8:30 a.m. - 5:00 p.m. (EST)
Fax: (202)554-5603
7 days, 24 hours
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JOIN THE TSCA CELEBRATION!
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