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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