More than 30 years after Congress enacted the Toxic
Substances Control Act, it is clear that we are not doing anadequate job of assessing and managing the risks of chemicals
in consumer products, the workplace and the environment. It
is now time to revise and strengthen EPA’s chemicals
management and risk assessment programs.
-- EPA Administrator Lisa Jackson, Jan. 23, 2009

Office of Pollution Prevention and Toxics2• On September 29, 2009, Administrator
Jackson announced plan to enhance
EPA’s chemical management programthat included the release of a set ofAdministration principles on TSCA reform.
• On April 15, 2010, Sen. Lautenberg
introduced the “Safe Chemicals Act of 2010.”
Administrator Lisa Jackson• On July 22, 2010, Congressmen Waxman andRush introduced the “Toxic Chemicals Safety Act of 2010.”

Office of Pollution Prevention and Toxics

13• Enacted in 1976, TSCA set a national program to:– Gather information on new and existing chemical substances and mixtures– Require testing of chemicals and mixtures– Screen and control unreasonable risks of new and existing chemicals andmixtures– Coordinate with other Federal agencies• Only major environmental statute not reauthorized• TSCA was intended to be the primary means of regulating theproduction and use of industrial chemicals

Office of Pollution Prevention and Toxics

4:• Lists existing chemicals in commerce -- originallycontained 60,000 chemicals.
• Current Inventory contains more than 84,000 chemicals• EPA collects production level and some exposure and use
information every five years• Information becomes publicly available, unlessconfidentiality is claimed

Office of Pollution Prevention and Toxics

5• Notifications required in advance of manufacture• Subject to a 90-day review• Unless EPA takes action, chemicals enter commerce
without further consideration• To date, EPA has reviewed more than 35,000 new
chemical notifications

Office of Pollution Prevention and Toxics

6• No comprehensive statutory requirement to test, prioritize oraddress existing chemicals• Testing of chemicals must be done through rulemaking
process and must make specific findings• Taking action to limit or ban chemicals is complex andburdensome– Only attempted nine ban actions under TSCA, including failed asbestos
banOffice of Pollution Prevention and Toxics

7• Voluntary phase-out of chemicals• Formal stewardship/commitment programs like 1998
High Production Volume Challenge– After 10 years, still working to fill gaps on sponsoredchemicals– Still lack data on a significant number of chemicals notsponsored in the Challenge, now using test rules– Since the Challenge began, more than 500 additional
chemicals have at some point been produced in highvolumeOffice of Pollution Prevention and Toxics

8• No mandatory program to determine the safety ofexisting chemicals.
• Difficult legal and procedural hurdles to limit or banchemicals• Significant hurdles to request the generation andsubmission of health and environmental effects data
• Confidential Business Information claims limit accessto information by the public & other governments

Office of Pollution Prevention and Toxics

9Office of Pollution Prevention and Toxics

10Chemicals Should Be Reviewed Against Safety Standards That
Are Based on Sound Science and Reflect Risk-based Criteria
Protective of Human Health and the Environment.

No mandatory review to determine the safety of existingchemicals
All chemicals on the market reviewed to determine safety

Office of Pollution Prevention and Toxics

11Manufacturers Should Provide EPA With the Necessary Information toConclude That New and Existing Chemicals Are Safe and Do Not Endanger
Public Health or the Environment.

Only data already available required from manufacturers for new chemicals– no data requirements for existing chemicals – additional informationcollected only through lengthy rulemaking.

Manufacturers required to submit vital data on all chemicals incommerce – EPA given clear authority to quickly require
submission of any other necessary data

Office of Pollution Prevention and Toxics

12Risk Management Decisions Should Take into AccountSensitive Subpopulations, Cost, Availability of Substitutes
and Other Relevant Considerations
Obstacles to quick and effective regulatory action to limit
or ban chemicals found to cause risks
Clear authority to take risk management actions whenchemicals do not meet the safety standard

Office of Pollution Prevention and Toxics

13Manufacturers and EPA Should Assess and Act on Priority
Chemicals, Both Existing and New, in a Timely Manner
Review of chemicals are hindered by weak requirements
and procedural hurdles. No requirement to review oldchemicals

Clear, enforceable and practicable deadlines set forcompletion of chemical reviews, in particular thoseimpacting sensitive sub-populations

Office of Pollution Prevention and Toxics

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Green Chemistry Should Be Encouraged and Provisions Assuring
Transparency and Public Access to Information Should BeStrengthened

Green chemistry efforts not mandated—substantial amounts ofimportant information claimed as confidential or not available tothe publicGreen chemistry explicitly encouraged and confidentiality
claims substantially limited— more and improved
information available to the public
Office of Pollution Prevention and Toxics

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EPA Should Be Given a Sustained Source of Funding forImplementation

Manufacturers pay nominal fees for review of new chemicals
but fees do not directly support EPA’s work

Fees assessed to cover the costs of reviewing chemicals—
directly supporting the work necessary to ensure the safetyof chemicals

Office of Pollution Prevention and Toxics

16• House and Senate bills share many elements• House bill introduced following stakeholder discussions• Burden placed on manufacturers and processors
to prove chemical substances and mixtures meet safety
standard• Significantly expands EPA authority to collect data andregulate use of chemicals• New and existing chemicals subject to same safety standard• New concepts include safety determination and mandatory
minimum data set
Office of Pollution Prevention and Toxics

17• Declaration of current manufacturing or processing within 1year• Rulemaking by EPA to establish minimum data set for all
chemical substances and mixtures within 1 year

• Minimum Data Set submission required for:– priority list chemicals within 18 months of listing– high volume chemicals within 3 years of enactment– moderate volume chemicals within 4 years– low volume chemicals within 5 years– new chemicals at submission of pre-manufacture notice• Order authority to compel testing
Office of Pollution Prevention and Toxics

18• Establishes priority list, starting with 19 substances• Within 1 year, EPA must expand list to no fewer than
300 existing chemical substances– list must always have a minimum of 300 existing chemicals– listed at EPA’s discretion, based on various factors– mixtures may also be added• Requires identification and expedited exposure
reduction for persistent, bioaccumulative and toxic
substances
Office of Pollution Prevention and Toxics

19• EPA must:– Apply a safety standard which “takes into account aggregate exposure
to a chemical substance or mixture and ensures that, for all intended
uses with regard to public health, there is a reasonable certainty thatno harm will result, including to vulnerable populations; and the publicwelfare is protected.”– Determine whether the substance or mixture meets the standard“taking into account any existing conditions or controls already ineffect, or can be made to meet the safety standard through theimposition of additional conditions,” or whether intended uses that
don’t meet the standard are critical

Office of Pollution Prevention and Toxics

20• Substances or mixtures which do not meet the safety
standard are effectively banned 1 year after thedetermination– EPA can extend this period up to 3 years• EPA may set conditions on use including:– prohibitions or limits on manufacturing, processing, distribution incommerce and uses

– may require marking with warnings and instructions on use• Critical use exemptions allowed

Office of Pollution Prevention and Toxics

21• Requires safety determinations in the pre-manufacture stagefor:– new chemical substances– new uses of existing chemical substances• Minimum data set submitted with new chemical premanufacture notices• EPA determines within 90 days if new substance or use is a
critical use or requires a safety determination• Safety determination must be completed within 9 months

Office of Pollution Prevention and Toxics

22• Publicly accessible database with all significant information,
including significant decisions• Ingredient disclosure throughout supply chain• Limits on confidentiality claims:– chemical identification and health and safety studies cannot be
claimed– requires substantiation and EPA review of a sample of claims whileallowing data sharing with other governments– approvals limited to no more than 5 years

Office of Pollution Prevention and Toxics

23• Preemption– no preemption unless simultaneous compliance with State and Federalrequirements is impossible• Hot Spots– establish criteria to define disproportionate exposure– identify localities disproportionately exposed– develop action plans• Safer Alternatives and Green Chemistry– must create market incentives for the development of safer alternatives,including an approval process and exemptions from certain requirements– establish a green chemistry research network• Minimize use of animal testing
Office of Pollution Prevention and Toxics

24The new legislation goes a long way toward ameliorating the major
structural flaws of TSCA.
Richard Denison, Environmental Defense Fund,July 22, 2010

We must strike the right balance and our assessment of [the House bill]as currently drafted promotes unworkable approaches to chemicals
management. It creates additional burdens that do not contribute toand, in fact, detract from making advances in safety, while coming up
short with respect to promoting innovation and protecting Americanjobs.
Cal Dooley, American Chemistry Council, July 29, 2010

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. . . we have serious concerns with this bill. And many of us genuinely
believe that if this legislation is passed as written and as amended theninstead of helping us create more jobs in America, it will help us lose
more jobs in America.
Rep. Ed Whitfield, Ranking Member, House
Subcommittee on Commerce, Trade and Consumer
Protection, July 29, 2010

We clearly need to protect the public, but we need to do so in a way that
does not stifle innovation and that protects American manufacturing andindustry, something that we have been hearing quite a bit about lately.
The United States has at this time a very fragile economy and we cannot
afford to lose any more jobs in this country than we have already lost.
Rep. John Dingell, Chairman Emeritus, House Energy &Commerce Committee, July 29, 2010
Office of Pollution Prevention and Toxics

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I’ve talked to [Senator] Lautenberg a lot on this subject. I can’t really tell
you the specifics or the ingredients that would come into a good TSCA
bill. I think we need to have one and he thinks so, too, and we mightsurprise everyone and come together on something.
Sen. James Inhofe, Ranking Member, Senate
Environment & Public Works Committee, Nov. 19, 2010
(as quoted in Inside EPA)

Office of Pollution Prevention and Toxics

27• TSCA and EPA’s Enhanced Chemical Management
Program: http://www.epa.gov/opptintr/• Legislative information from the Library of Congress:
http://thomas.loc.gov/

Office of Pollution Prevention and Toxics

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