»EPA
United States
Environmental Protection Agency
Pollution Prevention and
Toxics (7407)
Fall 1998
EPA 747-N-98-001
Chemicals in Our Community
News and Information
CHEMICAL
TESTING
Welcome to Chemicals
in Our Community
Lynn R. Goldman, M.D.
Assistant Administrator for Pollution Prevention,
Pesticides & Toxic Substances
At EPA we believe that giving people information on the chemicals to which
they are exposed is the right thing to do and the smart way to reduce pollution.
We know industrial facilities emit chemicals. But so does the local dry cleaner.
And we are exposed to chemicals used in our schools, grocery stores — and
homes. Chemicals are in thousands of consumer products we use every day, such
as household cleaners — even children's toys. Every citizen has a right and need
to know the chemicals that are transported, stored, released and used in their
communities. Citizens now have some of that information, but they need more.
Citizens need information on chemicals' toxicity and safe exposure levels, on
how the chemicals act in the environment: Do they persist? Do they accumulate
in our bodies? In other words, what are the risks?
Armed with this information, citizens could better decide for themselves
which household products to buy, whether to allow their children to play in the
school yard, or swim in a nearby lake or stream. They would be better able to
persuade owners of a small local business or a giant multi-national corporation to
switch to safer chemicals or reduce chemical use. Armed with good information
on chemicals in their communities, citizens could simply better protect them-
selves and their children and create a safer world.
on 2)
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Welcome to Chemicals in
Our Community
(continued from 1)
The Toxics Release Inventory and
other chemical right-to-know initiatives are
making this vision a reality. Since TRI
reporting began in 1988, industries required
to report reduced their emissions by almost
half, despite enormous growth in our
economy. And we have seen an explosion
in the public's demand for information on
chemicals in their communities. Public
access to existing web sites with right-to-
know information now averages over a
million "hits" or "visits" a day.
We are working hard to get all the
information citizens need to make decisions
to protect their health. This first issue of
Chemicals in Our Community focuses on an
important chemical right-to-know problem: a
complete lack of publicly available basic
toxicity data for 43 percent of the most
widely produced industrial chemicals, and
incomplete data for almost all the others. Not
knowing if many of the thousands of chemi-
cals to which we are exposed are toxic means
that we cannot assess the health and environ-
mental risks.
On the eve of Earth Day, Vice President
Gore once again championed citizens right-
to-know by announcing that EPA was
challenging the chemical industry to provide
health and ecological testing data for 3,000
of the most widely used chemicals in this
country. EPA will issue a follow-up rule to
require industry to fill in any gaps. And for
the first time we will require TRI reporting
about persistent chemicals that are toxic at
very low levels and that build up in animal
and human tissue and breast milk. We will
direct special attention to those chemicals
that children are most likely to encounter.
EPA is committed to taking direct
actions to protect public health and the
environment from industrial chemicals, as
well as enabling citizens to better protect
themselves from these potential threats. In
the months and years ahead, we hope
Chemicals in Our Community will help you
to learn more about these efforts.
Welcome to Chemicals in
Our Community Cover
Chemical Right-to-Know 3
Chemical Hazard
Availability Data 5
OECD Screening Informa-
tion Data Set (SIDS) 7
Considering the Costs
of Testing 8
Electronic Health & Safety
Studies 9
Chemical Testing for
Endocrine Disruptors 11
OECD Test Guidelines in
Health & Env. Effects 12
Hazardous Air Pollutant
Test Rule 13
Master Testing List 14
PMN Chemical Testing
Issues 15
Dermal Absorption Rate
Testing for OSHA 16
ChemAlliance: Compliance
Assistance Centers 17
What's New 18
Chemicals in Our Community is published
by EPA's Office of Pollution Prevention &
Toxics (OPPT) to increase public awareness
of and access to news and information on
toxic chemicals and pollution prevention
available through OPPT. This resource is
also available on the Internet at: http://
www.epa.gov/opptintr/opptpub.htm.
Mailing address:
Chemicals in Our Community
US EPA (7407)
Office of Pollution Prevention & Toxics
401 M Street, SW
Washington, DC 20460
Advisory Board:
IAB Project Manager: Georgianne McDonald
EAD Project Manager: Mary Wigginton
Publisher: Maria Hendriksson
Senior Editors: Georgianne McDonald,
Diane Sheridan, and Mary Wigginton
OPPT Divisional Representatives:
Dan Fort (EETD), Odelia Funke (IMD),
Patricia Grim (OPME), Leonard Kiefer
(RAD), Chris Tirpak (CCD), and Chen
Wen (PPD).
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Chemical Right-to-Know
A New Era of Environmental Protection
William H. Sanders, III, Dr. P.M., P.E.
Director, Office of Pollution Prevention and Toxics
It's not often one gets the chance to
hear the Vice President of the United States
explain bioaccumulation to a group of
fourth-graders. Not only did this unlikely
event take place during Earth Week, but he
did a terrific job. The kids were genuinely
interested and went back to their classes
with a lot to think over.
The occasion was the Vice President's
announcement of the Chemical Right-to-
Know Initiative, a major and important
undertaking for OPPT that will greatly
expand the information available on thou-
sands of high-priority chemicals. ChemRTK
arose from the realization that, even for the
most common chemicals in commerce, there
is very little data available on health and
environmental effects. OPPT's "Chemical
Hazard Data Availability Study" (see article
on page 5) revealed that fewer than 7% of
high-production volume (HPV) chemicals
have a full set of baseline testing data
publicly available, and almost half the
chemicals have no data available whatsoever!
The full study is available on OPPT's home
page (www.epa.gov/opptintr/chemtest).
The Chemical Right-to-Know Initiative
will fill in these gaps, and provide the basis
for better and faster decisions on where
chemicals present hazards to human health
and the environment, and on steps to elimi-
nate or manage these hazards. As such,
ChemRTK is fast becoming one of the most
visible and highest-priority efforts at OPPT.
It focuses, at the outset, on the three specific
actions identified by the Vice President:
Get baseline testing done on the 3,000
HPVs.
EPA will challenge industry to voluntar-
ily undertake baseline testing on HPV
chemicals on a very rapid schedule, using
internationally-recognized testing protocols.
Chemicals that are not covered by the
voluntary challenge program will be subject
to test rule requirements. We expect to
publish a test rule proposal in early 1999.
Conduct extensive testing on chemicals to
which children are disproportionately
exposed.
Children can be especially sensitive to
chemical exposures. OPPT will work with
other offices, agencies and stakeholders to
identify the chemicals in consumer products
that lead to significant exposures in children,
and will identify a battery of health tests
needed to better screen the risks of these
chemicals. Voluntary agreements, such as
on 4)
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4)
enforceable consent agreements (EGAs), will
be established with companies to test these
chemicals. The chemicals not covered by such
agreements will be included in a Children's
Health Test Rule which EPA will propose by
the end of 1998 and make final in 1999.
Collect TRI release information on high-
priority PBT chemicals.
Persistent, bioaccumulative, toxic
chemicals (PBTs) are of special concern due
to their environmental persistence and
tendency to concentrate in body tissues. Yet,
many PBTs are not covered under the Toxics
Release Inventory (TRI), the database which
contains information about potentially
hazardous chemicals and their use. We will
propose a rule to lower the threshold for
reporting of PBTs already on TRI, and to add
other PBTs (also at the lower thresholds) to
reporting requirements. EPA will propose the
PBT Rule by the end of 1998 and make it
final in 1999.
At the core of ChemRTK is EPA's
commitment to making data available to the
public in a form that is easy to access, use
| and understand. Virtually all of the informa-
| tion generated from this initiative will be
| made readily available through the Internet
| and in other forms, so that the public can
| access information about the chemicals in
I use in their homes, schools, workplaces and
I elsewhere.
I Of particular importance to me as the
I Director of OPPT is the development of a
I comprehensive Chemical Right-to-Know
I Strategy to put these activities into a larger
I context. Data alone can be a powerful agent
I for change, but OPPT clearly has a responsi-
I bility beyond simply providing new data.
I We must be prepared to act in a timely and
I decisive fashion when new information
I suggests heretofore unrecognized risks. The
I Chemical Right-to-Know Strategy will lay
I out the approaches OPPT will use to assess
I risks, establish priorities for testing and for
I risk reduction, and to take actions so that
I there are no industrial chemicals which pose
I "unreasonable risks."
I This truly is the beginning of a new era
I in environmental protection. Stay tuned to
I this publication for more information.
For further information about EPA's
Chemical Right-to-Know Testing Program, please contact:
Frank D. Kover, Chief - Chemical Information & Testing Branch
or Barbara Leczynski, Chief - Existing Chemical Branch
Chemical Control Division (7405)
Office of Pollution Prevention & Toxics
U.S. Environmental Protection Agency
401 M Street, S.W.,
Washington, D.C. 20460
Phone: (202) 260-8130 or (202) 260-3945
Fax: (202) 260-1096
E-mail: kover.frank@epa.gov or leczynski.barbara@epa.gov
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Chemical Hazard Data Availability Study
EPA's Chemical Hazard Data Availability Study finds major gaps in
the basic information that is readily available to the public on high
production volume chemicals.
Charles Auer, Director
Chemical Control Division
In an Earth Day 1998 announcement,
Vice President Gore and Administrator
Browner committed EPA to three initiatives
aimed at strengthening the public's right and
ability to know about the potential health and
environmental risks from toxic substances.
These initiatives build on OPPT's work in our
Right-to-Know and TSCA programs. In the
near future, OPPT will be asking chemical
manufacturers to voluntarily increase critical
testing for 3000 high production volume
(HPV) chemicals, pursuing new rules to
guarantee that the chemicals children are
exposed to are fully tested for their health
effects, and proposing
new, lower reporting
thresholds for the most
persistent and
bioaccumulative chemi-
cals on EPA's Toxics
Release Inventory (TRI).
The announcement on
the testing of high
production volume
chemicals is a direct result
of OPPT recent analysis of
the public availability of
basic testing and screening
information on chemicals
produced or imported at
more than 1 million
pounds per year (HPV
chemicals). EPA/OPPT
recently released its analysis on the availability
of SIDS (Screening and Information Data Set)
test data on US HPV chemicals (see article on
page 7). SIDS is considered the minimum set
of tests that can allow an informed screening-
level evaluation of a chemical's hazards. A full
text of the EPA report, entitled "Chemical
Hazard Data Availability Study: What do we
really know about the safety of high production
volume chemicals?", is available on the
Internet at www.epa.gov/opptintr/chemtest/
hazchem.htm.
The study found that of the 3,000 U.S.
HPV chemicals, a full set of SIDS testing was
publicly available for only 7% of the chemi-
Office of Pollution Prevention & Toxics
CHEMICAL HAZARD
DATA AVAILABILITY
STUDY
What Do We Really
Know About the
Safety of High
Production Volume
Chemicals?
ERA'S 1998 Baseline of
Hazard Information That Is
Readily Available to the Public
(April 1998)
cals and that no SIDS data were available for
43% of the chemicals. The report also
considers specific subsets of chemicals
including TRI-listed chemicals, those with
occupational exposure standards, and those
used in certain consumer products. In
addition, the report discusses the costs of
completing the tests needed to fill the data
gaps on these chemicals and offers a prelimi-
nary look at how individual companies who
produce HPV chemicals compare in terms of
the data available on their products.
Here are some of the highlights we found
when we analyzed the available data on these
subsets of chemicals of
special interest.
Chemicals reported
under TRI—203 HPV
chemicals appear on the
TRI list. One would
expect TRI chemicals to
be relatively well tested,
and, in fact, over half of
these high-volume TRI
chemicals have all six of
the basic screening tests,
and all of the TRI HPV
chemicals have at least
some data available.
Clearly, there are more
test data available on the
TRI chemicals than on
the full set of all HPV
chemicals, but there are still data gaps —
about 20% of the HPV TRI chemicals were
missing 2 or more of the basic SIDS tests.
On the other hand, many of the HPV chemi-
cals not listed on TRI lack the basic informa-
tion needed to determine if they should be
listed on TRI — nearly half of the non-TRI
listed HPV chemicals have no data available
and fewer than 4% have the full set of basic
tests. (See Figure 1, next page.)
Chemicals in the products we use —
Chemicals contained in consumer products
are of concern due to the likelihood of their
exposure to children, as well as other
on 8)
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5)
inn -r——
-$_•
c
ai
o RH -
Ti|r
Hazard Data Availability for U.S. HPV Chemicals
42.5
0-
0
13-S 10.3 9.3 9.0 8.1 7.1
1 23456
Number of Tests Available
Figure 1
jc
II, l\J ixI i
Proportion of Hazard Data Available for
830 U.S. HPV Chemical Companies
Q.
E
o
o
as
_Q
250
200
150
100
50
0
148
1flfi
189
164
118
Sd.
Ill 21
0/6 1/6 2/6 3/6 4/6 5/6 6/6
Proportion of Hazard Data Available
Figure 2
sensitive populations. Fortunately, the
industry has completed basic testing for more
of these chemicals than is the case for other
HPV chemicals — of the 491 HPV chemicals
listed on EPA's Indoor Air Source Ranking
Database, 25% have data publicly available
for all six SIDS tests, while only 7% have no
data available. Nonetheless, the great
exposure potential of consumer products and
the fact of children's exposure suggests the
need for additional testing beyond the SIDS
level so that we can adequately assess the
risks of such chemicals.
Chemical companies need to do more to
deal with this problem: Our preliminary
analysis shows that, out of 830 companies
making HPV chemicals in the US, 148
companies have no SIDS data available for
any of their products. An additional 459
companies sell products for which, on
average, half or fewer of the SIDS tests are
available, while only 21 companies produce
chemicals that are fully tested. (See Figure 2)
Much remains to be done — While
these groups of chemicals are relatively
more fully tested than the bulk of HPV
chemicals, it is alarming that basic testing
on human health hazards and ecotoxicity
have been not completed on such large
numbers of HPV chemicals. EPA is
launching a Chemical Right-to-Know
Initiative aimed at creating the information
base that is needed to accurately assess the
potential risks posed by the trillions of
pounds of chemicals in commercial use
today. A key element in this initiative is
focused on engaging chemical manufactur-
ers, interest groups, and other Federal
agencies in the US, along with government
and industry in other countries, in an
enlarged effort to rapidly complete SIDS
testing on all HPV chemicals.
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OECD's Screening Information
Data Set (SIDS)
Richard Hefter
Risk Assessment Division
Since the 1970's, member countries of
the Organization for Economic Cooperation
and Development (OECD) have been working
together to address issues of chemical safety.
The OECD includes the U.S., Mexico,
Canada, European countries, Japan, Korea,
and Australia. One of the major problems is
that of evaluating the tens of thousands of
chemicals already in commerce - "existing
chemicals." OECD members decided to
focus on the chemicals having the highest
worldwide production (over 2 million
pounds), and to collect for each one a
standard minimum set of data. OECD would
then use the data to screen these "high-
production-volume" (HPV) chemicals for
their potential risks to society. By 1990, the
United States and the other OECD member
countries were ready to start this voluntary
international testing program.
The basic level of testing and other
information gathered is called the Screening
Information Data Set, or SIDS. The SIDS
includes information on the identity of the
chemical, its physical and chemical proper-
ties, uses, sources and extent of exposure.
The testing required is designed to answer
basic questions about the chemical. For
instance, environmental fate testing can tell
us whether the chemical degrades quickly in
the environment and how it is distributed
throughout the environment.
The toxicity testing is designed to
measure how potent the chemical is from
acute or one-time exposures such as from
accidental ingestion or skin contact. Other
tests measure the effects from longer expo-
sures as might be encountered in the work-
place or in communities near production
facilities, such as mutagenicity tests which
could indicate a potential to cause cancer.
Tests are also required that measure the
chemical's ability to interfere with reproduc-
tion (fertility) and fetal development. Finally,
a number of studies are required that indicate
the potential for environmental effects such as
to fish and aquatic plants should the chemical
be released to water from production and
wastewater treatment facilities. While all
these tests do not fully measure a chemical's
toxicity they do provide a minimum set of
information that can be used to determine if
additional testing is necessary.
Once sponsor countries and their indus-
tries have selected chemicals to work on, they
collect data; prepare SIDS Dossiers (standard-
ized summaries of the available information)
and Testing Plans (for chemicals lacking
some of the SIDS data); circulate SIDS
Dossiers and Testing Plans to other countries
for review and approval; review and comment
on the documents prepared by other coun-
tries; carry out SIDS testing and add the new
data to the Dossier; and prepare a SIDS Initial
Assessment Report (SIAR). OECD review of
SIARs (at SIDS Initial Assessment Meetings,
or SIAMs) determines whether chemicals
have a low priority for further work or
whether further (Post-SIDS) testing or
analysis of more detailed exposure informa-
tion is needed.
The results of the SIDS program are
available to all countries through the Interna-
tional Registry of Potentially Toxic Chemi-
cals (IRPTC) and the International Program
for Chemical Safety (IPCS). The program
also cooperates with other international
programs concerned with chemical safety,
such as the World Health Organization.
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Considering the Costs of Testing
Lynne Blake-Hedges
Economics, Exposure and Technology Division
Chemical toxicity testing is often
required by the EPA under Sections 4 and 5
of the Toxic Substances Control Act (TSCA).
Manufacturers of the chemicals are generally
responsible for paying the cost of testing.
Costs of testing can vary significantly, and
certain tests can be expensive. The Agency
estimates that many tests can exceed
$100,000 and some, such as cancer toxicity
tests, can exceed $100,000. A Screening
Information Data Set (SIDS), a typical battery
of testing, generally ranges from $200,000 to
$280,000. Recent Chemical Marketing
Reporter (June 29, 1998) estimates for
chemical industry value of shipments exceed
$391 billion, some percentage of which is
attributable to those chemicals with little
toxicity information.
Therefore, to balance the need to gather
information about chemical toxicity against
the desire to minimize costly regulatory
actions, the Agency considers testing costs in
its decisions about chemical testing. This
consideration of the costs of testing require-
ments is a relatively straightforward concept.
Agency economists carefully anticipate which
companies will be subject to the requirements
of the rule. They assess the value of sales
from a chemical, usually based upon the
estimated volume produced and/or processed
and the chemical sales price.
In cases where the chemical is new and
not yet commercialized, price and produc-
tion projections from the manufacturer are
used. Judgments are then made about the
affordability of the testing when multiple
manufacturers produce a chemical, and
they might share testing costs. The Office
of Pollution Prevention & Toxics (OPPT)
generally considers that test costs exceed-
ing 1 percent of sales value suggest a
possible adverse effect on the businesses
involved. In this case, the Agency will
more closely examine the testing require-
ments. Similarly, the Agency also evalu-
ates the potential effects on small busi-
nesses of chemical testing.
For existing chemicals, the value of all
sales is compared with the costs of the testing
requirements to assess the industry's ability to
afford the testing without adverse effects.
With new chemicals, the Agency considers
both the ability to afford testing and the time
at which testing costs are recovered based
upon projected production.
Estimates of the costs of testing include
laboratory costs (equipment, supplies, etc.)
and laboratory labor hours. Other costs
considered include costs of soliciting labora-
tory bids, selection of laboratories, preparing
test protocols, monitoring tests under
progress, and preparing reports to EPA on the
testing. The cost of testing requirements can
extend beyond the actual test itself and
include forming agreements with other
manufacturers for cost-sharing and export
notification. Further, if EPA requires
chemical testing, that chemical is automati-
cally covered by export notification require-
ments. That is, if the chemical is exported,
the company must notify EPA, and EPA
notifies the destination country that they are
receiving this chemical.
The results of the EPA's analysis of the
costs can be used to help shape the testing
requirements put forth by EPA. Frequently,
testing requirements may be tiered, such
that more expensive or advanced testing
may be required only if results of a screen-
ing test suggest a need for further testing.
For new chemicals, the time at which test
results are required is often related to the
estimated time for those costs to be recov-
ered through sales.
Given the number of industrial chemi-
cals available today that have little or no
toxicity data, toxicity testing will clearly
continue to be necessary. In meeting the
challenge to ensure the availability of such
information while minimizing the costs to
the businesses that provide it, the EPA will
continue to include costs as one of the
considerations in developing testing
requirements.
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Electronic Health and Safety Studies
John Nowlin
Information Management Division
Chemical manufacturers have been
submitting health and safety studies to the
EPA since the inception of the Toxic Sub-
stances Control Act (TSCA) in 1976. These
studies, submitted under Sections 4 and 8 of
TSCA, include studies of chemicals or
mixtures that may present an "unreasonable"
(Section 4a) or a "substantial" (Section 8e)
"risk of injury to health or the environment."
EPA also asks for studies (Section 8d) on
chemicals for which there are insufficient
data. Most of these studies were submitted in
response to chemical testing recommenda-
tions made by the TSCA Interagency Testing
Committee (ITC). Every year the ITC
reviews numerous Section 8(d) studies and
decides whether testing for health effects,
environmental fate, or ecological effects is
needed. To date there are over 100,000
studies covering over 9,000
chemicals in EPA's TSCA test
submission database called
TSCATS.
Summary
information from
the TSCATS
database can be
accessed free of
charge through the
Right-to-Know
Network (RTKNET)
located at www.rtk.net.
RTKNET allows the user
to select the level of detail
they want in their report. There are
three levels of reports, the first of which
allows the user to chose a report that will
produce a description of each reference
matching the search criteria. The second
type of report provides the same informa-
tion as well as a list of specific chemicals
and studies. The third report provides all
the information mentioned plus the full text
of abstracts.
Although the health and safety studies
themselves are not currently on-line, they are
available from the EPA's Confidential
Business Information Center (CBIC) located
at 401 M Street SW, Room E-G099, Wash-
ington, DC 20460. A new EPA web site is
being developed to allow industry submission
of health and safety studies electronically.
This effort, started over two years ago, is part
of an Agency-wide initiative to improve
electronic commerce throughout the EPA.
In July 1996, as part of the EPA's
electronic commerce initiative, the EPA's
Office of Pollution Prevention and Toxics
(OPPT) invited industry, organizations,
public interest groups, laboratories, the press,
federal agencies and individuals to meet with
the EPA in an open session to discuss ways
to improve the timeliness, accessibility and
quality of information reported under TSCA.
The meeting generated tremendous energy,
and resulted in a commitment to the elec-
tronic submittal and dissemination of health
and safety data. The group agreed
that the best way to collect health
and safety data would be to
convert the existing paper-based
health and safety data (HaSD) form
into an electronic means of submit-
ting the data. This electronic HaSD
form will allow for the direct
uploading of health and
safety summary data
directly into TSCATS
and to electronically
attach the full study.
Less than a year after
the first meeting, the
electronic HaSD form
was put into use.
The electronic HaSD form is
currently being used to collect health and
safety data for the ITC. To date, the ITC has
reviewed over 40,000 chemicals and will soon
be using TSCATS to post information on these
chemicals on their web site. To learn more
about the ITC, visit www.epa.gov/opptintr/itc.
OPPT's new Chemical Right-to-Know
(CRTK) program will also use the electronic
HaSD form and TSCATS to post chemical
information on EPA's web site. CRTK
includes collecting studies on almost 3,000
high production volume chemicals - chemi-
cals that are produced or imported in quanti-
ties greater than a million pounds a year.
on 10)
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9)
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i -v*
TSCATS
Figure 1
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lC-infiT-. If.y.1 •.HiiSIJ! I1ir l\i> '.-'i Kki.ln.iii
Figure 2
Data on these chemicals will be made
available to the public under Vice
President Gore's Chemical Right-to-
Know initiative, an initiative to allow the
public to easily access to information
about chemicals in their community (see
article on page 3).
OPPT plans to publish health and
safety information on the EPA web site.
The design of the web page includes a
user-friendly interface that will allow the
public easy access to information on
chemicals of interest. The new web site
will include the ability to access health
and safety information at various levels of
complexity (depending on the user's
needs). OPPT will continue to improve its
ability to collect and disseminate informa-
tion to fulfill the communities' right to
know about chemicals. As part of this
commitment, OPPT holds regular open
sessions on the electronic submission and
dissemination of TSCA data.
To request information on the next
electronic open session meeting, write to:
John Nowlin (7407), US EPA, 401 M
Street, SW, Washington, DC 20460 or
send an e-mail to nowlin.john@epa.gov.
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Outside Experts Recommend Chemical
Testing Process for Endocrine System Effects
GaryTimm
Chemical Control Division
In recent years, increasing scientific
and public attention has been focused on
the potential effects of synthetic chemi-
cals on the hormone, or endocrine,
systems of people and wildlife.
The endocrine system consists of the
glands and the hormones they produce
that help guide the development, growth,
reproduction and behavior of animals
including human beings. The glands of
the endocrine system include the pitu-
itary, thyroid, and adrenal, as well as the
ovaries and testes. The hormones pro-
duced by these glands travel through the
bloodstream and affect functions in other
parts of the body. For example, adrenaline
helps stimulate physical activity; estrogen
affects the female reproductive system;
and androgen affects the male reproduc-
tive system.
Chemicals that interfere with the
normal function of these complex systems
are known as "endocrine disrupters." For
example, some chemicals may mimic a
natural hormone, "fooling" the body into
over responding to the hormone. Other
chemicals may block the effects of a
hormone in parts of the body normally
sensitive to it.
In response to the increasing concerns
about potential endocrine effects, Con-
gress included provisions in the 1996
Food Quality Protection Act and amend-
ments to the Safe Drinking Water Act that
require EPA to develop by August 1998 a
program for screening and testing chemi-
cals for adverse effects to endocrine
systems. To meet this ambitious Congres-
sional deadline and to include the latest
scientific thinking, EPA established the
Endocrine Disrupter Screening and Testing
Advisory Committee (ED STAC) to provide
advice and recommendations.
The EDSTAC met nine times between
December 1996 and June 1998, and will
submit its final recommendations by Septem-
ber. The committee focused on screening
pesticides, contaminants, and commercial
chemicals for estrogenic, androgenic, and
thyroid hormone effects. With the universe of
chemicals to be prioritized for endocrine
screening and testing numbering more than
86,000, the committee has recommended a
tiered process to detect endocrine disrupting
chemicals and quantify their effects that
includes initial sorting of chemicals, priority
setting for chemicals to be tested, and a
battery of eight in vitro and in vivo screening
assays, and a battery of four multi-generation
(rodent, fish, invertebrate) tests.
Updates on OPPT and EDSTAC
activities can be found on the Internet at
www. epa. gov/opptintro/opptendo.
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OECD Test Guidelines in Health and
Environmental Effects
Michael C. Cimino
Risk Assessment Division
Differences in test guidelines between
offices of the U.S. Environmental Protection
Agency have the potential of leading to
confusion and to unnecessary testing of
chemicals. Similarly at the international
level, differences in test guidelines between
nations lead to unnecessary testing of
chemicals in world commerce. To avoid
duplication of testing, the Office of Pollution
Prevention and Toxics (OPPT) and the Office
of Pesticides Programs (OPP) have been in
the process of harmonizing their guidelines
for human health and ecotoxicity testing into
a single set of guidelines for the Office of
Prevention, Pesticides and Toxic Substances
(OPPTS), and in the process are harmonizing
these OPPTS guidelines with those of the
Organization for Economic Cooperation
and Development (OECD).
The OPPT/OPP project
was begun in 1990 and is
nearing completion. The
harmonization effort
between OPPT with OECD
had been ongoing since
the mid 1980's.
International harmo-
nization of test guidelines
has been a high priority for
Assistant Administrators of OPPTS since
1990. By cooperating closely with other
Federal agencies, states, tribes, and non-
governmental organizations, and with their
counterparts in other countries, the EPA is
reducing the burden to regulated industry,
increasing efficiency in collecting test data
and in assessing risk, avoiding duplication of
effort, saving animal lives and expense,
reducing non-tariff trade barriers and foster-
ing the mutual acceptance of test data
between the U.S. and other countries.
OPPT has published 118 guidelines not
only in the areas of human health and
ecotoxicity, but also in environmental fate
and physical chemistry. OECD has pub-
lished 55 guidelines in the same four areas.
OPP has a total of 97 test guidelines in these
areas, plus 129 additional guidelines for
other specific requirements for OPP's
evaluation of pesticides (e.g., product
identity, performance, composition, applica-
tion exposure).
Presently, 30 health effects guidelines
and six ecotoxicity test guidelines have been
harmonized between EPA/OPPT and OECD.
Ten health effects guidelines and 13
ecotoxicity guidelines have been harmonized
between OPPT and OPP to produce guide-
lines which are unique to OPPTS. Some of
these OPPTS test guidelines incorporate
recent and significant advances in the
scientific knowledge and methodologies,
particularly in the areas of neurotoxicity,
developmental neurotoxicity, develop-
mental and reproductive biology,
aquatic plant toxicology and sediment
toxicology. OPPT is currently
leading many of the
efforts to harmonize these
improved guidelines with
OECD. These guidelines
are being revised in light of
OPP Science Advisory
Board (SAP) comments in
May and October 1996.
In July 1998, EPA
will publish 45 OPPT/OPP
harmonized guidelines in health effects for
key toxicity tests (acute toxicity, specific
organ/tissue toxicity, subchronic toxicity,
chronic toxicity, genetic toxicity, neurotoxic-
ity, reproductive and developmental toxicity,
immunotoxicity and metabolism and
pharmokinetics) will be published in the
Federal Register. They will also be available
electronically in PDF (portable document
format) on the EPA World Wide Web site at
www.epa.gov/epahome/research/htm, or via
the U.S. Government Printing Office (GPO)
at ww.access.gpo.gov or in disk or paper
form (call GPO at 202-512-0132).
It is expected that at least 10 guidelines in
ecotoxicity (the 850 series) should be harmo-
nized and finalized by the end of this year.
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Hazardous Air Pollutant Test Rule
Richard Leukroth
Chemical Control Division
Since the Clean Air Act was amended in
1990, EPA's Office of Air and Radiation
(OAR) has used a "technology-based" and
performance-based approach to significantly
reduce emissions of air toxics from major
sources of air pollution. Under this approach,
OAR develops standards for controlling the
routine emissions of air toxics from each
major type of facility within an industry
group. These standards — know as
"maximum achievable control technology"
(MACT) standards — are based on emission
levels that are already being achieved by the
better-controlled and lower-emitting sources
in an industry. To date, OAR's Office of Air
Quality Planning and Standards has com-
pleted work on some 22 MACT standards.
Eight years after a MACT standard is issued,
OAR must assess the remaining health risk
(also called residual risk) from that source
category. If the residual risk assessment
indicates a continued concern about potential
health effects that may occur at MACT
standard exposure levels, then OAR may
implement additional standards that address
any significant remaining risk.
While OAR focuses efforts on develop-
ing MACT standards, they have asked EPA's
Office of Research and Development to
develop an approach to assess residual risk
(see Residual Risk Report to Congress; 63 FR
19914; April 22, 1998) and to collaborate
with EPA's Office of Pollution Prevention
and Toxics (OPPT) to use TSCA section 4(a)
as a means to obtain identified data needed
for this future assessment. The data obtained
through TSCA would be used to implement
several provisions of section 112 of the Clean
Air Act, including determination of residual
risk, estimation of the risks associated with
accidental releases of chemicals, and determi-
nations regarding whether substances should
be removed from the Clean Air Act Section
112(b)(l) list of hazardous air pollutants. In
addition, the data will be important for EPA's
Chemical Right-to-Know program as well as
for other Federal agencies—the Agency for
Toxic Substances and Disease Registry, the
National Institute for Occupational Safety and
Health, the Occupational Safety and Health
Administration, and the Consumer Product
Safety Commission—for assessing chemical
risks and taking appropriate actions within
their programs.
As an initial effort to build this database,
OPPT proposed the HAP Test Rule in June
1996. OPPT identified 21 High Production
Volume chemicals from the List of Hazardous
Air Pollutants that require additional data. The
proposed rule would require that industry test
these HAP chemicals for health effects from
inhalation exposures using the eleven OPPTS
harmonized test guidelines published in the
Federal Register (FR6243820, April 15, 1998).
This is the first TSCA chemical test rule
that gives industry the opportunity to submit
alternative testing proposals which, if
acceptable to EPA, would permit industry test
sponsors to enter into Enforceable Consent
Agreements (EGAs) with the Agency that
would use state of the art methods to perform
route-to-route extrapolations of health effects
of chemicals from existing data where the
route of exposure was not by inhalation.
These methods — pharmacokinetics and
mechanistic data—describe how the body
absorbs, distributes, metabolizes, and excretes
a chemical. OPPT has received alternative
test proposals for almost half of the chemicals
listed in the HAPs rulemaking.
On December 24, 1997, the proposed
rule was amended to cross-reference the
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Master Testing List (MIL)
Frank Kover
Chemical Control Division
he
Since 1990, EPA's Office of Pollution
Prevention and Toxics (OPPT) has used the
Master Testing List (MTL) — a list of
industrial chemicals that are considered to
be the highest priority for its chemical
testing program under the mandates of
Sections 2 and 4 of TSCA. The MTL helps
EPA program managers focus limited
Agency resources on the highest priority
chemical testing needs, publicize OPPT's
industrial chemical testing priorities,
obtain public input on program priorities,
and encourage voluntary industry initia-
tives to conduct needed testing. OPPT adds
individual chemicals and chemical catego-
ries to the MTL as a result of the TSCA
Interagency Testing Committee activities
and requests by other EPA program offices,
other Federal agencies, as well as OPPT's
Existing Chemicals Program.
The MTL currently lists over 600
chemicals and more than 15 chemical
categories such as endocrine disrupters,
oxygenated fuel additives, paint stripping
products and chemicals, and hazardous air
pollutants. All of the chemicals and catego-
ries on the list are "active" in ongoing testing
programs, testing action development, or
testing needs development.
With Vice President Gore's 1998 Earth
Day announcement, EPA anticipates the
size of the list to increase significantly
with the addition of chemicals that may
pose the greatest risks to children and the
3,000 chemicals, labeled High Production
Volume (HPV) chemicals, that are pro-
duced or imported in amounts over one
million pounds per year. EPA expects to
issue the next version of the MTL some-
time in 1999. Given the expanded scope
from adding the HPV chemicals, it may be
necessary to reformat the list.
The current (1998) version of the MTL
is available in hard copy from OPPT's
Public Docket and the TSCA Hotline, (202)
554-1404. The electronic version is on the
Internet at www.epa.gov/opptintr/chemtest/
index.htm.
(continued
proposed testing requirements to the new
eleven harmonized TSCA guidelines. In
this amendment, the Agency removed
certain testing requirements; revised the
economic assessment; proposed criteria
to help determine who is required to test
a HAP chemical that is a byproduct or
impurity; and described other changes
and clarifications to the proposed test
rule. To help meet requirements con-
tained in the proposed amended rule,
EPA also solicited EGA proposals on
HAP chemicals for which proposals had
not been received.
Once again, on April 21, 1998, the
proposal was amended to modify the
provisions for identifying persons who are
required to test and to provide additional
guidance in determining what their
responsibilities would be under the rule.
With the close of the comment period,
June 22, 1998, OPPT staff is working to
complete the EGA negotiations and finalize
the rule as soon as possible. Comments and
support documents for the HAPs rulemaking
can be found, on the Internet at
www.epa.gov/fedrgstr/EPA-TOX/1997/
December/Day-24/s-t3 3451 .htm.
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PMN (Premanufacture Notice)
Chemical Testing Issues
David Schutz
Chemical Control Division
In implementing the Vice President's call
to gather basic test data on the most widely
used chemicals, EPA will have the ability to
screen these chemicals for potential effects on
human health and the environment. EPA's
ability to perform toxicity screening has been
substantially developed through its New
Chemicals Program. Under this Program, the
Agency routinely screens chemicals before
they are manufactured for commercial use.
EPA's New Chemicals Program sets the
pace for the chemical industry's testing of
new chemicals for potential health risks.
Section 5 of TSCA requires that anyone
wanting to manufacture a "new" chemical,
i.e., one that is not on EPA's list of chemi-
cals in commerce known as the TSCA
Inventory, must submit a Premanufacture
Notice (PMN) for EPA approval. OPPT's
New Chemicals Program then assesses the
proposed chemical for its uses, benefits,
and its potential to harm human health and
the environment.
EPA's assessment of a chemical's
potential risk is based partly on test results
submitted its PMN and partly on existing
information on similarly structured chemi-
cals. EPA has been collecting and evaluating
data on chemicals for
almost 20 years, and
as a result the
program has built an impres-
sive storehouse of information
on the hazards such chemicals
can pose.
Although TSCA
requires that a manu-
facturer submit to the
Agency any toxico-
logical or environ-
mental test data it has
on a chemical at the
time of its PMN
application, there
is no defined
base data set of
hazard informa-
tion, and TSCA does not require prior
testing of new chemicals. Less than half of
the PMN applications include toxicological
data. In evaluating PMNs for which no or
little data is provided, EPA scientists
predict toxicicity by assessing the
chemical's structural similarity to chemi-
cals for which toxicological data are
available in a process called structure-
activity relationship analysis (SAR).
The Agency's SAR knowledge base has
largely been accumulated through the New
Chemicals program and through testing
submitted under sections 4 and 8 of TSCA.
When data available to the New Chemicals
Program is not adequate to assess the
toxicity and risk of the new chemical, the
Agency often requires that additional data
be generated.
EPA toxicologists, chemists, biochemists,
engineers, and experts in other disciplines
work together to predict the potential risks to
human health or the environment from each
new substance. Most of the new chemicals
submitted to the program complete the review
process without being restricted or regulated
in any way. However, if the Agency deter-
mines that a new chemical substance may
pose an unreasonable risk or that production
volume and potential worker or environmen-
tal exposure is substantial, EPA can take
action to control the new chemical.
EPA uses a variety of
approaches in obtaining test
data needed to assess or
manage new chemicals
risks: (1) permit the
PMN submitter
to manufacture
or import the
new substance
under specified
conditions,
S where deviation
from the conditions would require
submission of test data; (2) require
ubmission of test data before a speci-
on 18)
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Dermal Absorption Rate Testing for OSHA
Keith Cronin
Chemical Control Division
EPA is developing a proposed Test
Rule under Section 4(a) of the Toxic
Substances Control Act (TSCA) that could
require manufacturers (including importers)
and processors of 47 chemical substances of
interest to the Occupational Safety and
Health Administration (OSHA) of the
Department of Labor to conduct dermal
absorption rate testing.
EPA was asked by the TSCA Interagency
Testing Committee (ITC) to require the
chemical industry to test about 80 chemicals
for dermal absorption rates. The request came
from OSHA, which needs absorption rate data
to determine whether workers need to wear
protective equipment when handling certain
chemicals. In anticipation of this request, the
Office of Pollution Prevention and Toxics
(OPPT) and ITC developed a method for in
v/'/ro-dermal absorption rate tests for screen-
ing workplace chemicals. On the basis of the
test method, EPA solicited Enforceable
Consent Agreement (EGA) testing proposals
from industry. Through an EGA, industry
agrees with EPA to conduct specific tests on a
specified schedule. The EGA is a more
flexible tool for all parties than rulemaking.
EPA received one offer from industry to test
one chemical via an EGA. OPPT is currently
preparing a proposed TSCA Section 4 Test
Rule for 47 chemicals with the highest
production volume and highest number of
workers exposed for which no adequate data
have been reviewed. At a later date, EPA
will propose testing for the remaining
chemical substances of interest to OSHA.
fied production volume or date is
reached (known as "triggered" testing);
or (3) permit the PMN submitter to
suspend the review period while devel-
oping additional test data (this approach
works best where the needed testing can
be completed relatively quickly). EPA
takes action to control new chemicals for
about 10% of the cases.
When the Agency specifies (using a
consent order under Section 5) condi-
tions under which it will permit manu-
facture or import of a new substance
pending development of test data,
manufacture of the new substance can take
place under precautions for workers or
environmental safeguards (e.g., protective
equipment, use restrictions, methods of
waste disposal) which the Agency believes
provide a remedy for the possible risks. In
cases where the Agency determines that a
new substance will present an unreasonable
risk, EPA can prohibit the manufacture,
processing, or distribution in commerce of
the substance.
For more information on this program
visit the New Chemicals Program website at
www .epa. gov/opptintr/newchms.
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ChemAlliance
Compliance Assistance Center Coming Soon!
David Piantanida
Environmental Assistance Division
Who is ChemAlliance?
ChemAlliance is a compliance assistance
center designed for the chemical industry. It
was established in the fall of 1997 under a
cooperative agreement funded by EPA's
Office of Enforcement and Compliance
Assurance (OECA). EPA has partnered with
the National Center for Clean Industrial and
Treatment Technologies (CennCITT), Pacific
Northwest National Laboratory (PNNL), and
the University of Wisconsin - Solid and
Hazardous Waste Education Center
(SHWEC) in this effort.
The Center's objectives in serving each
of these markets are to assist the company
level individual in understanding and
maintaining compliance and to enhance the
capabilities of industry by providing useful
and accurate information.
Why ChemAlliance?
ChemAlliance will help users to sort
through existing information and direct them
immediately to the best solution.
What is ChemAlliance?
ChemAlliance is designed to assist the
chemical industry to more efficiently achieve
and maintain compliance with environmental
regulations with an emphasis on pollution
prevention. Specifically, ChemAlliance will:
• Provide information that addresses the
environmental compliance needs of the
chemical industry.
• Improve information transfer between
individual companies and EPA, and
among assistance providers.
• Provide practical information on how
chemical manufacturers can improve
compliance while reducing costs and
improving quality.
• Help chemical manufacturers decrease
the costs and increase the effectiveness
of compliance.
Information will soon be provided via
a World Wide Web site and will contain an
"expert help desk" function that will
enable users to locate important informa-
tion quickly. The ChemAlliance web site
and toll-free hotline will be launched in
September 1998.
Who are Expected to be the Primary Users
of this Center?
• Individual company representatives
charged with compliance at one or
several facilities
• Individuals or organizations that
provide assistance to industry
I6VC
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What's New
1996 TRI Data Release
Announced
Through its Toxics Release
Inventory (TRI), the U.S. EPA
recently reported industrial
releases of toxic chemicals in
U.S. communities decreased
from 2.5 billion pounds in 1995
to 2.4 billion pounds during
1996, a decline of 4 percent or
100 million pounds. Since
industry first began reporting
releases in 1988, releases have
decreased by almost 46 percent.
The 1996 TRI report also
includes industry-specific analyses
of five major industry sectors that
are required to report their toxic
chemical releases. Over the past
10 years, all of these industries
have reduced the amount of toxic
pollution they report to EPA. Of
these five industry sectors,
declines in TRI chemical releases
were led by chemical manufactur-
ing, followed by primary metals,
electrical equipment, pulp and
paper, and petroleum refining.
EPA will complete a report later
this summer containing analyses
of the additional 15 industries
that report to the TRI.
Information on TRI is
available in public libraries, or
on-line at www.epa. gov/
opptintr/tri, or by calling the TRI
User Support at (202) 260-1531.
New Standards and
Information Program Help
Protect Families and
Children from Lead Paint
Hazards
EPA has proposed new
standards and is issuing a final
rule, effective June 1999, that
addresses health hazards from
lead-based paint. The proposed
standards identify levels of lead
and provide consumers with
information about lead-based
paint hazards of renovating or
remodeling their homes. The new
rule will require renovators, who
are working for compensation, to
give homeowners and tenants
information on how to protect
themselves from lead hazards
before renovation begins.
The new rule and proposed
standards cover homes built
before 1978. There is an estimated
80 percent of all residences built
before 1978 which contain some
lead-based paint. Although it can
usually be safely managed, when
lead-based paint is disturbed
during renovation it can contami-
nate dust and soil and pose a
significant hazard, especially to
young children. Almost one
million children under the age of
six have unsafe levels of lead in
their bodies, making lead poison-
ing the number one environmental
health hazard for young children.
Copies of both the proposed
and final rules as well as a
pamphlet on lead hazards in the
home for renovators to use are
available on EPA's web site at
www.epa.gov/lead or by calling
the hotline at (800) 424-LEAD.
Final Report on Endocrine
Disruptors Screening Due
in July
At a final meeting of EPA's
Endocrine Disrupter Screening
and Testing Advisory Committee
(EDSTAC), committee members
provided final comments on the
draft report. This report recom-
mends a strategy for screening and
testing chemicals to determine
whether they have potential to
affect endocrine function in
humans, fish, and wildlife.
The EDSTAC was established
to implement a provision of the
Food Quality Protection Act and
Safe Drinking Water Act amend-
ments that require screening and
testing protocols for chemicals
suspected of endocrine disrupting
effects. More information on
EDSTAC can be found on the web
at www.epa.gov/opptintr/opptendo/
index.htm or by calling the Key-
stone Center at (970) 468-5822.
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What's New
EPA Publishes Final
Guidelines for Ecological
and Neurotoxicity Risk
Assessment
EPA completed guidelines for
doing ecological and neurotoxicity
risk assessments. Both guidelines
were developed to foster consis-
tency across the Agency for
planning and conducting risk
assessments. The guidelines for
ecological risk assessment
describe three phases of the
process, general principles, and
examples of how the principles
can be applied to situations such
as hazardous waste clean-up, new
pesticide registration, or water-
shed management. The neurotox-
icity risk assessment guidelines
are intended to guide the
Agency's evaluation of chemicals
suspected of causing adverse
neurological effects, with a focus
on the vulnerability of infants' and
children's nervous systems. The
guidelines are available on EPA's
web site at www.epa.gov/ncea.
New Software Identifies
Building Products for
Environmental Performance
As part of its Environmen-
tally Preferable Purchasing
(EPP) Program, EPA has con-
tributed to the development of a
software program that helps to
identify products that will reduce
energy use, improve air quality
and other conditions that can
improve the environmental
performance of buildings. The
software program, Building for
Economic and Environmental
Sustainability (BEES), was
developed under an Interagency
Agreement by the National
Institute of Standards and
Technology with funding from
EPA. The program will help
federal facility managers make
decisions about how to purchase
building products based on cost
and environmental consider-
ations. For more information see
the web site at www.usgbc.org.
OPPTS Assembles
Community-Based
"Tool" Box
OPPTS has published an on-
line version of Act Locally, a
compilation of OPPTS databases,
programs, funding opportunities,
hotlines, training opportunities,
and other pesticide/toxics related
activities that can be used by
communities to gather more
information for improving their
local environments. The listings
will be updated periodically and
nominations for new items are
welcome.
Pollution Prevention
Centers Across US
Network for Better Service
EPA has established a new
network for pollution prevention
information and technical
assistance through a grant
program that is funding nine
regional pollution prevention
centers. In February 1998,
representatives from each of the
centers met to develop a decision
making process, standardize
bibliographies, establish quality
assurance protocols, and discuss
evaluation and measurement
issues.
In addition to the grant
program, OPPT allocated an
additional one million dollars to
fund activities in each of these
centers that improve state
cooperation. Without the states'
investment of staff time and
resources, regional centers
cannot survive. The network,
called the Pollution Prevention
Resource Exchange (P2Rx)
provides information that is
readily accessible and updates
technical information. The
network is easy to search,
collect, synthesize, and identify
experts and other sources of
information. More information
about the network can be found
on EPA's web site at
www.epa.gov/p2.
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