Lynn Goldman, Assistant Administrator (November 1998)
TSCA: Looking Back -- Looking Forward
Remarks Prepared for Delivery by
Lynn R. Goldman M.D.
Assistant Administrator
Office of Prevention, Pesticides and Toxic Substances
U. S. Environmental Protection Agency
Washington, D.C. 20460
"Living With TSCA"
Sponsored by Chemical Manufacturers Association
Synthetic Organic Chemical Manufacturers Association
Renaissance Hotel
Washington, D.C.
November 13, 1998
Good morning. Thank you ... for that kind introduction. I would also like to thank the sponsors of
this important conference for inviting me --- CMA, SOCMA, API, the Chemical Specialties
Manufacturers Association, the National Association of Chemical Distributors, the National Paint
and Coatings Association, and the Society of the Plastic Industry. It's always a pleasure to be
here. As you know, I will be leaving EPA at the end of year, so I am especially pleased to have
the opportunity to look back with you and take stock of what we have accomplished as well as
assess the challenges ahead.
When I came into this job, many of us were expressing frustration with TSCA. There was a sense
that at after 20 years it had become outdated. We needed new and different authorities to
adequately protect Americans from chemical risks. EPA's chemicals program seemed to be
running in place -- and TSCA's reauthorization was not on the horizon. Today -- five years later -- TSCA still needs to be updated, but I am struck by the progress we have made without its
reauthorization. The program is beginning to deliver the kind the environmental and health
protection Americans need. Much of the credit for that progress goes to you in industry and to
many of you.
I think several important changes have pushed us forward. Each is a major accomplishment in its
own right and each has had a galvanizing effect as well -- I am thinking of citizens' right to know,
government reinvention, the globalization of chemical safety and industry's product stewardship.
Over the past five years, the greatest single catalyst to better chemical regulation has been
citizens' right-to-know. Awareness by citizens and businesses of the tremendous amount of
chemicals being released in communities and by specific facilities has brought about a fundamental
change in the way all of us -- citizens, government and industry -- approach chemical regulation
and safety.
We have found that arming citizens with information is the single most effective way to reduce
risks. The Clinton Administration has acted on that conviction. Under the leadership of President
Bill Clinton and Vice President Al Gore, we nearly doubled the number of chemicals and chemical
categories that must report emissions in TRI, and expanded by 30 percent -- to 31,000 -- the
number of facilities that must report. As a result, since 1988, publicity on TRI has prompted
companies to cut nearly in half releases of toxic chemicals -- without any additional command and
control regulations. These reductions reflect the hard work of facilities that refined their
processes, took advantage of source reduction opportunities and undertook outstanding
housekeeping practices.
The Internet has intensified the power of citizens' right-to-know. EPA's web sites and
Environmental Defense Fund's site, Scorecard, which includes information on relative toxicity of
emissions, are making it as easy for people to get information on local emissions as is for them to
log on to their computer. More than 150,000 citizens visit these Web sites each month.
Recognizing the central role that information plays in environmental protection, I would like to
take moment to say a few words about the Y2K problem. I do not have to tell you how much
both EPA and industry depend on the free flow of electronic information to carry out our work.
As you may know, Congress passed legislation to enable companies to share information about
their experiences trying to fix the problem without the fear of lawsuits. Goverment and industry
also need to tackle this problem together. We will be following up later to give you the names of
persons in the TSCA program who will be available to work with you to on Y2K. For ongoing
information on EPA's efforts to deal with Y2K, you can check our Y2K web site at
www.epa.gov/year2000.
Returning to the subject of citizens' right-to-know -- we have recently taken a giant step --
together -- to give citizens the information they need to protect themselves. Last April Vice
President Al Gore challenged you, the chemical industry, to close the huge gap in the public's
access to basic health effects information for high production volume chemicals that are released
every day into our air, land and water and contained in thousands of consumer products. These
are the chemicals that the United States imports or produces at more than 1 million pounds per
year. You rose to the challenge, and last month the Vice President announced a new voluntary
chemical testing program developed jointly by EPA, the Chemical Manufacturers Association and
the Environmental Defense Fund.
Why is this testing needed? Because no publicly available basic toxicity information exists for 43
percent of all HPV chemicals and only 7 percent of these chemicals have full sets of basic toxicity
data publicly available. We have a full set of screening quality toxicity data for only about half of
the chemicals on TRI. I think we all can agree that citizens have a right and a need to know more
about a chemical emitted in their community than just its name.
This chemical right-to-know challenge builds upon a foundation created by the Organization for
Economic Cooperation and Development in the late 1980's to assure that basic information is
available on international HPVs. The chemical right-to-know challenge complements the OECD
program by adopting the same internationally agreed-upon set of minimal tests known as the
Screening Information Data Set or SIDS. Our program will give a huge boost to the OECD's
program -- and to citizens right-to-know worldwide
The immediate next step is for chemical companies to come forward and commit to making their
existing data publicly available and, where necessary, to conduct testing to fill in the gaps. Please
take this message back to your management. To ensure that SIDS data are available for all HPV
chemicals, EPA will issue a rule by the end of 1999 for testing those chemicals that companies do
not elect to test voluntarily.
As each American company voluntarily steps forward and tests the chemicals it produces and
discloses the information publicly, that company's community, its employees, its stockholders --
and its customers, the American public -- will know that Responsible Care is not just a slogan.
I am heartened by this program. It is a huge undertaking. I know that my office and Administrator
Browner will work cooperatively with you -- especially with smaller chemical companies -- to
ensure that you have the support you need to carry out the pledges you have made.
Recently, we have launched another important new chemical testing program -- which also
depends on your support. It will initially screen and test 15,000 chemicals produced in volumes
of greater than 10,000 pounds a year for their potential to disrupt human endocrine systems. It,
too, is a huge undertaking, and will fill in critical gaps in health effects information for our
citizens. Required by the 1996 Food Quality Protection Act, the program must begin screening
and testing next year. It is worth noting that it is the first time since enactment of the 1976 Toxics
Substances Control Act that Congress has directed EPA to require chemical testing.
EPA proposed the program in August following advice by an expert scientific panel, which
included CMA and other major stakeholders. The effort responds to growing concern that some
chemicals can "mimic" our body's hormones, disrupting the endocrine system and causing
developmental and reproductive health problems. Chemicals that will be a high priority for
screening will certainly include all the pesticides, and many of the chemicals found in thousands
of everyday products and used in workplaces across this country. The results of the screens will
be used to determine which chemicals require full testing for endocrine disrupting effects and
subsequent possible regulatory controls.
Because of right-to-know, Americans are better equipped to tackle environmental problems by
demanding more information and greater emissions reductions. And just as right-to-know has
injected new energy in the TSCA program so, too, have the programs that fall under the umbrella
of government reinvention -- stakeholder partnerships and collaborations, innovative and flexible
approaches to regulation, and pollution prevention.
In the past, the primary aim of our environmental programs was to control, treat or clean up
pollution. Now we know that it is far better to focus on the source of pollution, through process
redesign, conservation and product life cycle management. To achieve that goal, rigid EPA-prescribed procedures are being supplemented or supplanted by more flexible approaches that
reflect industry's determinations on how best to meet performance-based standards. EPA had
often found itself an adversary of industry; now we understand the value of working cooperatively
to achieve environmental results.
Citizens' right-to-know has been a major force behind this shift and a primary catalyst for
pollution prevention. As companies began replacing dangerous chemicals with safer alternatives
and redesigning manufacturing processes to reduce emissions by preventing pollution, both
industry and government quickly learned that pollution prevention made sense in every way. It
costs less over the long term and can be more effective than end-of-the pipe controls because
there is less waste, disposal costs, and potential for environmental liability. Most importantly,
preventing pollution broke the defeatist cycle of shifting dangerous contaminants from one
environmental media to another.
In the past five years, the chemical industry and EPA have worked together on reinvention
projects, and through those efforts, we have found new ways to eliminate sources of pollution. I
am thinking of The Design for the Environment program, and our Green Chemistry Challenge, in
which new, safer materials and processes are being invented.
At the same time, we have been trying to take a more holistic approach. Traditional single
pollutant, single-media approaches are giving way to multi-media considerations, so pollution is
not simply shifted from our air, to our water, to our land. On that score, I am happy to say that
this Monday EPA will announce the details of a new strategy which -- for the first time -- will
fully coordinate its resources and statutory authorities to tackle the challenge of reducing
persistent bioaccumulative toxics, or PBTs.
These substances, such as DDT, PCBs and chemical byproducts, such as dioxins -- persist in
our environment and are very mobile. As they move up the food chain, they concentrate and
accumulate in animal and human fatty tissue. Highly toxic, these pollutants are linked to
serious health effects -- dysfunction of the immune and metabolic systems, neurologic deficits,
reproductive abnormalities, and cancer, as well as endocrine disruption.
Like the chemical right-to-know challenge, the effort to tackle PBTs grew in part out of our
international commitments. Under the U.S.-Canada Great Lakes Bi-National Toxics Agreement,
the United States agreed to take actions to reduce emissions and uses of 12 high-priority
PBTs. For example, we pledged a 50 percent reduction in the release and use of mercury by
2006, reductions of 75 percent for dioxin releases and a 90 percent reduction in the use of
PCBs in electrical equipment by 2006.
Under the PBT strategy, we will develop and implement national action plans to reduce
emissions of the 12 PBTs covered by the U.S.-Canada treaty. Each plan will target reductions
across environmental media, minimizing instances in which a pollutant is simply transferred
from one media to another. The first draft plan -- a prototype for others -- has been completed
for mercury, and Monday it will be released with the strategy for public comment.
An expansion of citizens right-to-know is pivotal feature of PBT strategy. We will add new PBTs
to the TRI list and lower reporting thresholds for others already on the list so that the public can
be aware of local sources of these pollutants. The problem has been that many PBTs are generally
emitted in amounts that fall well below the 10,000 pound-per-year level that triggers the TRI
public reporting requirement.
At the same time, we will take steps to ensure that new PBTs are not introduced into
commerce, using the tool of choice, pollution prevention. Under the strategy, TSCA will play a
key role here. On October 5, EPA announced a policy to develop a new category of persistent,
bioaccumulative, and toxic substances for regulation under TSCA's new chemicals program.
Basically, the new policy calls for a tiered testing scheme based on specific criteria reflecting the
potential for risk. PBTs falling into the first tier are those that show a half-life persistence in
aquatic environments of between two and six months and a bioaccumulation factor of between
1,000 and 5,000. For these substances, we would use consent orders requiring controls on
releases to protect against exposure, and would require testing as a condition of approval.
The next tier would include chemicals meeting a persistence criterion of more than 6 months and a
bioaccumulation criterion of equal to or more than 5,000. Chemicals meeting these criteria have
properties consistent with substances widely acknowledged to be highly persistent,
bioaccumulative, and toxic. PCBs and DDT are examples. This same criteria for screening for
PBTs can be found in CMA's product risk guidance manual and underscores CMA's commitment
to Responsible Care. For chemicals meeting this second-tier criteria, EPA would restrict
manufacture until the chemical's testing is complete and risks have been evaluated.
In addition, we are considering basing the determination of potential risk from a new chemical on
its total environmental load and have asked for public comment on this approach. Releases to all
environmental media would be factored into the determination, including air emissions from
stacks, wastes disposed of in landfills or on land, and effluent discharged into water.
New chemicals characterized as suspected persistent bioaccumulative toxic substances might need
to undergo further testing on persistent and bioaccumulative endpoints. If confirmed, they would
undergo toxicity testing, with control requirements set as appropriate.
Under the strategy, we will look for opportunities to promote cleaner technologies and
substitutes. We will work with partners in industry to prevent pollution. Already, EPA has
partnered with the American Hospital Association to reduce mercury use in hospitals across the
United States. Similarly, the chloralkali industry has pledged to voluntary reduce its mercury
emissions by 50 percent. The automobile manufacturing industry is moving to replace mercury
switches in auto lamps with a safer substitute.
OPPTS also is using technical experience gained in the TSCA program to help other offices
reduce PBTs and prevent their introduction into commerce. One example is the Waste
Minimization Prioritization Tool, which we have designed with the Office of Solid Waste to use in
targeting 53 hazardous wastes with PBT characteristics for waste minimization.
Our efforts to reduce PBTs demonstrate how regulation of chemicals in the United States is both
pushing forward and being pushed by international commitments on chemical safety.
Last summer, 102 countries began negotiations under the auspices of the United Nations
Environment Program on a global agreement to eliminate emissions of almost the same 12
PBTs -- Persistent Organic Pollutants, or "POPs" as they are called internationally, and to
indentify criteria and a process for identifying and managing other POPs.
There are other new developments in global chemical safety. Last summer, the United States and
94 other countries reached an historic agreement to give countries the ability to restrict the
importation of 27 toxic industrial chemicals and pesticides. These 27 chemicals have been
banned or severely restricted by at least two countries. The agreement, which would establish
a procedure for prior informed consent for trade of these chemicals, has been signed and sent
to the home countries of its signatories for ratification. When ratified, it will require
participating countries exporting these 27 chemicals to first receive permission from the
importing country before shipping the chemicals.
We also are tackling the important job of harmonizing international approaches to chemical
review, registration and standard-setting and making the information as accessible as possible
through computerized data bases and registries. The benefits are potentially great -- improving
food safety, reducing huge regulatory and resource burdens on national governments and
corporations, and improved science through greater information exchange -- as well as reduced
trade problems.
For example, the Organization for Economic Cooperation and Development has laid the
groundwork for harmonization by adopting approximately 140 test guidelines and principles for
good laboratory practices to ensure the reliability of test data and to make the data acceptable to
the member countries for use in their risk assessments. And a few weeks ago, the OECD
countries reached an agreement on an international classification scheme for chemicals for toxicity
to the aquatic environment and a number of categories of human toxicity. Next steps will include
using hazard classification agreements to label chemicals for transport and on workplace Material
Safety Data Sheets. This voluntary system will be a major step toward global chemical safety.
I recently heard an industry colleague lauding PIC as "good common sense." PIC, like voluntary
testing on the scale of the HPV chemicals, represents a real change in attitude on the part of
industry. Right to know, FQPA, Responsible Care, liability -- all have played a role in changing an
ethic which held in essence that a chemical was "innocent" until proven otherwise. Now we
assume there may be a risk, unless proven safe. There is no doubt that industry is taking ever
greater responsibility for the safe management of the chemicals that they manufacture and use.
In passing the Toxic Substances Control Act in 1976, Congress gave us a basic framework to
protect citizens against risks from new and existing chemicals, and because of it we have made
enormous gains. Every day the law's basic functions continue to move forward. Every day TSCA
is responsible for requiring companies to evaluate substantial risk information on chemicals or for
keeping some toxic substances off the market. Yet, we know that TSCA is not up to the task at
hand. So we must ask ourselves: How can TSCA be strengthened?
Over the past 20 years, we have learned something about environmental strategies for the 21st
century. We know that they need to take into account the interrelationships of pollutants in the
full array of exposure routes -- air, water, and land. They need to deal with pollutants within an
international framework and the framework of prevention, with reductions in use and waste.
They need to reflect sound science, encourage right-to-know, promote environmental justice and
protect children and other vulnerable populations. They need to come about with the
participation and insight of the full range of stakeholders who are equipped with relevant
information. They need to be flexible and based on common sense.
There is widespread agreement that regulatory decisions need to be based on strong science and
sound data. But to better accomplish this, the Agency needs more information with which to
make decisions about risk from chemicals, including toxicity and exposure. This is a shared
responsibility.
A case in point involves Section 5, which requires companies to give EPA premanufacture
notification for chemicals before they enter commerce. More than half of all premanufacture
notifications are submitted without any test data. To deal with this situation, the Agency
developed tools to use Structure Activity Relationships (SAR) to predict and assess the fate and
effects of new chemicals. The time has come to revisit this situation.
Other systems, most notably the pre-marketing notification scheme used in the European Union,
require that notifiers develop and submit a base set of testing on new chemicals. We need to
consider requiring the minimum data set of tests like SIDS when chemicals that have gone to
market become high production volume chemicals.
I would like to take a moment to talk about concerns over the provisions in Section 6 for
responding to unreasonable risks from existing toxic chemicals.
Impediments to using Section 6 are severe, particularly when compared to the cost-benefit
analysis required under the Federal Insecticide, Fungicide and Rodenticide Act, which has a cost-benefit test but puts the burden on the pesticide registrant to demonstrate the safety of a proposed
pesticide use.
Given the constraints, the Agency has been able only to issue a handful of actions on existing
chemicals since 1978 under TSCA. This contrasts with hundreds of actions under our pesticide
reregistration program.
Under Section 6's requirements the hill up which EPA must roll the boulder before taking
regulatory action is steep, particularly in light of the decision by the U.S. Fifth Circuit Court of
Appeals to remand the 1989 asbestos ban and phaseout rule to EPA.
First, the court's decision appears to impose a burden of proof on EPA that significantly increased
the level of analysis on potential substitutes and on identifying the least burdensome approach for
any future Section 6 action. In most cases, EPA will never have the staffing or budget to meet
such a burden.
Second, the court's interpretation of the least burdensome alternative under Section 6 appears to
be that end-of-pipe solutions, where toxic substances are controlled after they are distributed into
the environment, are less burdensome than pollution prevention solutions, where toxic substances
are reduced or eliminated at their source.
Due to the limitations in Section 6, our existing chemicals program has increasingly used
voluntary measures to promote pollution and reduce risk. We have worked with various
stakeholders -- industry, states, community and environmental justice groups, and EPA regions --
to fashion voluntary accords to produce real-world results.
Although voluntary approaches will continue to be our tool of first choice, a stronger TSCA is
needed to make the voluntary approach meaningful, and when voluntary approaches don't work,
the nation needs a strong TSCA Section 6 as a backstop.
For the past 20 years, EPA has sought to balance our statutory duty under TSCA to protect the
public against the risks of chemicals in commerce and our statutory duty to protect industry
proprietary information. But looking at the information landscape under TSCA for recent years
reveals some troubling signs. For example, more than 65 percent of the information filings
directed to the Agency through TSCA were claimed as confidential. Submissions under the
recent Inventory Update Rule show that about 20 percent of facility identities were claimed as
confidential. And probably 40 percent of Section 8(e) substantial risk notices still have chemical identity claimed as confidential.
Importantly, states cannot receive CBI filings under the statute. Probably the lion's share of the
chemical risk management decisions in this country are done at the state and local level under a
variety of statutes. With 65 percent of data filings submitted under TSCA claimed as confidential,
effective governmental risk management clearly is frustrated.
So we need to revisit the CBI provisions under TSCA. I am certain there are better ways to give
the public the information it needs about chemical risk while protecting the interest of business.
In concluding these remarks, I want to thank you for you support these past five years. You have
educated me, and I thank you for that. I have come not only to respect your judgment, but to
realize that without your input none of the more innovative types of actions to protect public
health would have been possible because they depend on the people who know the chemicals and
the processes; they depend on people like you and your colleagues who work with chemicals
every day.
I am impressed with the progress we have made over the last few years. Many of you no doubt
recall that it was only three years ago that I stood before this group to decry efforts to weaken
environmental protection -- by Congress and supported by many in industry. Today it is clear we
have entered a new age of environmental stewardship; it is based on giving citizens the
information they need to make choices; it is based on voluntary action by industry, and on
forward-looking developments in the design, manufacture, and use of chemicals and chemical
products. Where we are in agreement on our goals, we need to tap into that creativity and
knowledge for strengthening TSCA to provide the most forward-looking tools. There are critical
opportunities for transforming TSCA's 1970s' strategies into ones that will carry us into the 21st
century. Together, we can move toward a more sustainable world. Thank you.
