TSCAThe Toothless Tiger

by Craig Collins, Ph.D. ©

Toxic Chemicals: Creeping CrisisBetween 1 & 2 thousand new

chemicals are marketed every year.

• Many are dangerous at extremely low doses. – Some are harmful in parts per trillion.

(1: 1,000,000,000,000)* *A stack of a trillion dollar bills lying on it side

would circle the Earth 2.73 times.

• Latency: Harmful effects may not appear for decades after exposure.

• Toxic substances bioaccumulate.– Humans are the top of the food chain.

• Toxic substances often persist– They don’t break down for decades.– When they do, they often produce

toxic by-products.

An Ounce of Prevention?• In 1976, Time magazine

warned readers that, “chemists are introducing new compounds at the rate of more than 1,000 a year.” It encouraged Congress to enact a law that would “carefully spot & screen potentially hazardous substances before they get into the environment.”

• This preventative policy was exactly what the Toxic Substances Control Act (TSCA, 1976) was supposed to do.

TSCA: The Mother of AllEnvironmental Laws?

• In theory, TSCA possessed a proactive, preventive mandate of sweeping breadth & scope.

TSCA’s Goal:To restrict or ban dangerous chemicals before they are marketed in specific products; used in particular settings; or transformed into pollution.

Lamed by Loopholes

• It took 4 years for TSCA to make it through Congress.

• By then it was riddled with gaping loopholes.

But TSCA Failed Miserably--Why?Problem #1) EXCLUSIONS:

Instead of screening ALL chemicals…

• Lobbyists from the pharmaceutical, nuclear power, cosmetic, pesticide, food & tobacco industries insisted their products should get a free pass because they were already covered in some way by other statutes.• Consequently, pesticides, tobacco, nuclear material, drugs, cosmetics & certain food additives were all excluded from TSCA’s controls.

Regulating Old & New ChemicalsProblem #2) The

“Unreasonable Risk” Loophole:

• TSCA gives EPA the authority to control old & new chemicals* that present an “unreasonable risk of injury to health or the environment.”– Unreasonable is a slippery

legal “wiggle-word” that chemical company lawyers have used time & time again to successfully challenge chemical regulation in court.* Old chemicals (sec. 4) were on the market

before TSCA became law; new chemicals (sec. 5) were produced after this.

Safe Until Proven DeadlyProblem #3)

The Testing Loophole:– Under TSCA, industry does its

own testing on OLD chemicals.• These tests have been shown to be

incomplete & fraudulent.– Majority of IBT labs 10,000 plus tests found to be

“invalid.”

– EPA cannot do further tests unless it can demonstrate that a chemical may pose an unreasonable risk.

– But without further testing this is very difficult to establish.

• The EPA has NO information on 80% of the 48,000 toxic chemicals in its old chemical inventory.

• Less than 10% have been tested for long term cancer, reproductive, or mutagenic effects.

More Roadblocks After showing unreasonable risk, the EPA must:– Choose the least burdensome

regulation to reduce risks to a reasonable level;

– Make sure that the benefits of regulation outweigh the costs.

• The court ruled that EPA could not ban asbestos although 10,000 Americans die each year (about 30 deaths per day) from diseases caused by it.(Corrosion Proof Fittings v. EPA)

Rushing New Chemicals to Market• TSCA requires industry

to notify the EPA 90 days before releasing a new chemical into the market.– Notices* are suppose to

contain testing data, but tests are not mandatory.

– If EPA does not ban, restrict or require further testing within 45 days, industry is free to market the chemical after 90.

*These are called a Premanufacture Notices (PMNs)

Before EPA can ban, restrict or require further tests, it must show that this new chemical may present an unreasonable risk. But it usually lacks the scientific basis to show this in court because industry has not submitted enough data.

Unknown Dangers…• About 67% of the new chemicals

surveyed lacked ANY toxicity data; 85% had only limited testing data.

• Of the high-volume new chemicals surveyed industry did not provide:– Carcinogenetic tests for 63%.– Reproductive toxicity data for 53%.– Neurotoxicity tests for 67%.– Immune system toxicity tests for 86%.– Studies evaluating the impact on

children for 90%. – Any tests for the synergistic impacts of

multiple chemicals.

Risk Assessment —> Risk Management(1) Hazard Identification:

What healthproblems are linkedto this chemical?

(2) Dose-Response Assessment:What’s the relationship between the

level of exposure & the probability & types of health effects?

(3) Exposure Assessment:What levels of exposure are people

experiencing in the real world?

(4) Risk Characterization:How serious are the dangers of

exposure to this chemical?

– Determine what levels of exposure constitute an “unacceptable risk.”

– This decision is based on politics & economics as much as health.

Another Approach To RiskThe Precautionary Principle…

Forces potential polluters to bear the burden of proof that their activities are safe in an open, informed, democratic policymaking process.

• When an activity raises threats of harm, precautionary measures should be taken even if some cause & effect relationships are not fully established scientifically.

• The proponent of an activity, rather than the public, should bear the burden of proof.

• This principle must be applied in an open, informed & democratic manner & must include potentially affected parties.

• It must involve an examination of the full range of alternatives--including no action.