Chemistrys Impending Brush with the Law:

Long-Awaited Reform of the

Toxic Substances Control Act
Richard A. Denison, PhD
Lead Senior Scientist

Main US Chemical Safety Legislation

Toxic Substances Control Act of 1976 (TSCA)
Covers most chemicals used in industry and in commercial/consumer products
Excludes:
Uses in drugs, cosmetics, food, and food packaging regulated by FDA
Uses in pesticides covered by EPA under FIFRA
Basic provisions have never been amended

What Is Meant by Chemical Policy?

Set by all three branches of government
Legislation (TSCA 100 pages long)
Enacted by Congress
Provides an agency with authority to implement
Regulation (TSCA regs 1,500 pages and counting)
Adopted through administrative rulemakings
Court decisions (case law)
Usually result of legal challenge of a regulation

Drivers for Chemical Policy Reform

Chemicals Are Ubiquitous

10 trillion pounds produced per year in the US
90 pounds per person per day
Used to make 96% of all materials and products
Large but unknown number of chemicals in US commerce
85,000 listed on Toxic Substances Control Act (TSCA) Inventorynot all in commerce
today
62,000 were on the market in 1979 (first inventory)
23,000 new chemicals added since then (500-1000/year)

Chemical
Production and
Use Are Growing

Source: Wilson and Schwarzman (2008) Green

Chemistry: Cornerstone to a Sustainable California,
University of California, based on data from
American Chemistry Council 2003; OECD 2001;
United Nations 2004.

Chemical production: 25x increase globally

Growth in number, types of chemicals has been less
dramatic

Diversity of use is dramatically rising, especially in

consumer products and building materials
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Science Drivers: Connecting the Dots

Certain chronic diseases are on the rise

Science Drivers: Connecting the Dots

Certain chronic diseases are on the rise
Certain chemicals are linked to those same chronic diseases

Science Drivers: Connecting the Dots

Certain chronic diseases are on the rise
Certain chemicals are linked to those same chronic diseases
Many of those same chemicals are in us

Rising Incidence of Diseases/Disorders Linked to Chemical Exposures

Source: Wilson and Schwarzman. (2008). Green Chemistry: Cornerstone to a Sustainable California, University of California.

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Rising Incidence of Diseases/Disorders Linked to Chemical Exposures

Source: Wilson and Schwarzman. (2008). Green Chemistry: Cornerstone to a Sustainable California, University of California.

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Diseases Linked
to Chemical
Exposures

Cancer
Learning and developmental disabilities
Parkinsons and Alzheimers disease
Reproductive health and fertility problems
Asthma
Diabetes
Obesity
Immune disorders
Cardiovascular disease
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Whats Changed Since 1976?

Understanding of extent and pathways of chemical exposures
Long-range transport
Migration of chemicals from products into environment, people
Coal tar-based sealants used on parking lots
BFRs in furniture foam
Disproportionate exposures: environmental justice issues
Advent of biomonitoring
Early-life exposures

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Some of the
Chemicals Widely
Detected in US
Population
through
Biomonitoring

Chemical

Phthalates
(Seven kinds)
Bisphenol A
Perfluorinated
compounds
(Four types)
PBDEs
(many)
Triclosan
PCBs
(many)

Source: Woodruff, T.J., Program on Reproductive

Health and the Environment, UCSF.

Percent of US
population
with measurable
levels*

Sources

5097%

Flooring, wall covering, medical

devices, food wrap, personal care
products, lacquers

92%
91-99%
100% (with at least
one congener)

Polycarbonate plastic, food can

lining, dental sealant
Nonstick cookware, stain
resistant fabrics, food packaging,
dental products
Chemical flame retardants,
upholstery, carpet, electronics

80%

Antimicrobial agent, soaps

100% (with at least

one congener)

Banned in 1977persistent
through food

*Representative US sample from NHANES/CDC generally from 2003/2004, PCBs for women
ages 16-39
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Early Life Exposures Can Lead to Adverse Outcomes Later in Life

Prenatal exposures to toxic chemicals and
suspected human health consequences
BPA
Behavioral abnormalities like
hyperactivity and aggressiveness
Flame retardants
Learning disabilities
Impaired motor skills
Phthalates
Attention deficit hyperactivity disorder
(ADHD)
Complex,
carefully orchestrated human
Abnormal
reproductive
development
starts at development
the point of
fertilization

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Whats Changed since 1976?

Risk assessment evolution and controversy
Red Book (1983), and a major update Silver Book (2009)
Key challenges
Human variability
Uncertainty
Cumulative effects and exposures
Multiple chemicals
Chemicals and other stressors

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Whats Changed since 1976?

Emerging high-throughput testing: Tox21
Potential to:
Address huge backlog of untested chemicals
Consider multiple cell types and life stages
Test at many different doses
Assess mixtures
Inform green chemistry

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Why Legislative Reform?

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TSCA: Problems
with Current
Paradigm

Existing chemicals
Presumption of innocence: TSCA grandfathered 62,000
chemicals
Default: no or uncertain info = no action
High hurdle to require testing
Proof of harm needed to regulate
Government shoulders burden of proof
Contrast to pesticides, drugs
Excessive trade secret allowances deny information to
the public and the market

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TSCA, the Dog that Didnt even Bark

By the numbers:
62,000 chemicals grandfathered in when
TSCA was passed in 1976
Required testing on <300 in 36 years
Five chemicals have been regulated in
limited ways
22 years since EPA last tried (and failed)
to regulate a chemical: asbestos

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TSCA: Problems with Current Paradigm

New chemicals
No data, no problem: no upfront testing requirement or minimum data set
Unlike virtually every other developed country in world
Guessing game: EPA is forced to heavily rely on limited prediction models
No reliable models for most mammalian tox endpoints
Catch-22: to require testing, EPA must first show potential risk or high exposure
Anti-precaution: lack of evidence of harm taken as evidence of no harm

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Why Now?

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Drivers for TSCA

Reform

State legislation and policy changes

Shift from bans to policies: CA, ME, WA
Top priority of last two EPA administrators
Market demand, especially from downstream users
Retail regulation
Major reform of others policies:
European Unions REACH Regulation
Canadian Environmental Protection Act

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REACH: Why All

the Commotion?

No data, no market
Addresses legacy of grandfathered chemicals
Shifting the burden of proof
Industry required to show safety
Information flow in supply chains
Two-way flow between suppliers <--> customers
Authorization required to use substances of very high
concern (SVHCs)

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The Global
Impact of REACH

Countries adopting aspects of REACH:

China
Japan
Australia
South Korea
Turkey
Taiwan
India
Vietnam

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Industry Position Shifts

The publics confidence in the federal chemical management system has been
challenged.
Cal Dooley, President, American Chemistry Council
Congressional testimony, February 26, 2009
In the absence of reforms to TSCA we are seeing a plethora of State actions that are
serving to create tremendous uncertainty in our markets.
Linda Fisher, Chief Sustainability Officer, DuPont
Congressional testimony, March 9, 2010

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TSCA Reform Bills (Five Successive Congresses)

US Senate

Congress

First bill: Kid-Safe Chemicals Act of 2005

Revised and reintroduced in 2008

109th

Became Safe Chemicals Act in 2010

Revised and reintroduced in 2011, 2013

110th-112th

May 2013: Chemical Safety Improvement Act

First bipartisan TSCA reform legislation
13 Republican and 12 Democratic cosponsors

113th

US House of Representatives
Toxic Chemical Safety Act of 2010

110th

Feb 2014: Chemicals in Commerce Act

Only a discussion draft

113th
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Start of a Paradigm Shift

Current: unless there is evidence of harm, assume safety and dont look any further
Needed: require affirmative evidence of safety to enter or remain on the market

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For More Information

EDFs chemicals policy webpage
www.edf.org/health/policy/chemicals-policy-reform
EDFHealth blog
http://blogs.edf.org/health/

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