08 - chemistry's impending brush with the law - long-awaited reform of the toxic substances...
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Chemistry's Impending Brush With the Law - Long-Awaited Reform of the Toxic Substances Control ActTRANSCRIPT
Chemistry’s Impending Brush with the Law: Long-Awaited Reform of the Toxic Substances Control Act
Richard A. Denison, PhD Lead Senior Scientist
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
Main US Chemical Safety Legislation
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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
What Is Meant by “Chemical Policy”?
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Drivers for Chemical Policy Reform
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) Inventory—not all in commerce
today 62,000 were on the market in 1979 (first inventory) 23,000 new chemicals added since then (500-1000/year)
Chemicals Are Ubiquitous
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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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Certain chronic diseases are on the rise
Science Drivers: Connecting the Dots
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Certain chronic diseases are on the rise
Certain chemicals are linked to those same chronic diseases
Science Drivers: Connecting the Dots
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Certain chronic diseases are on the rise
Certain chemicals are linked to those same chronic diseases
Many of those same chemicals are in us
Science Drivers: Connecting the Dots
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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. 10
Rising Incidence of Diseases/Disorders Linked to Chemical Exposures
Source: Wilson and Schwarzman. (2008). Green Chemistry: Cornerstone to a Sustainable California, University of California. 11
Diseases Linked to Chemical Exposures
Cancer
Learning and developmental disabilities
Parkinson’s and Alzheimer’s disease
Reproductive health and fertility problems
Asthma
Diabetes
Obesity
Immune disorders
Cardiovascular disease 12
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
What’s Changed Since 1976?
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Some of the Chemicals Widely Detected in US Population through Biomonitoring
Source: Woodruff, T.J., Program on Reproductive Health and the Environment, UCSF. 14
Chemical
Percent of US population
with measurable levels*
Sources
Phthalates (Seven kinds) 50–97%
Flooring, wall covering, medical devices, food wrap, personal care products, lacquers
Bisphenol A 92% Polycarbonate plastic, food can lining, dental sealant
Perfluorinated compounds (Four types)
91-99% Nonstick cookware, stain resistant fabrics, food packaging, dental products
PBDEs (many)
100% (with at least one congener)
Chemical flame retardants, upholstery, carpet, electronics
Triclosan 80% Antimicrobial agent, soaps
PCBs (many)
100% (with at least one congener)
Banned in 1977—persistent through food
*Representative US sample from NHANES/CDC generally from 2003/2004, PCBs for women ages 16-39
Complex, carefully orchestrated human development starts at the point of
fertilization
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) Abnormal reproductive development
Early Life Exposures Can Lead to Adverse Outcomes Later in Life
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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
What’s Changed since 1976?
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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”
What’s Changed since 1976?
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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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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
TSCA, the Dog that Didn’t even Bark
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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
TSCA: Problems with Current Paradigm
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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 Union’s 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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“The public’s 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
Industry Position Shifts
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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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Current: unless there is evidence of harm, assume safety and don’t look any further
Needed: require affirmative evidence of safety to enter or remain on the market
Start of a Paradigm Shift
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EDF’s chemicals policy webpage www.edf.org/health/policy/chemicals-policy-reform
EDFHealth blog http://blogs.edf.org/health/
For More Information
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