1. Industry Perspective on TSCA Modernization ABA Conference June 11, 2010

2. ACC’s 10 Principles for Modernizing TSCA 1.Chemicals should be safe for intended use 2.EPA should prioritize chemicals 3.Efficient and expeditious safety decisions 4.Companies should provide information necessary to make safety decisions 5.Children’s risks should be a factor in safety decisions

3. ACC’s 10 Principles 6.Flexible risk management authority for EPA 7.Enhance public access to chemical information 8.Rely on valid scientific data and information 9.EPA resourced to ensure chemical safety 10.Modernized TSCA should encourage innovation and preserve the industry’s competitive position

4. State of Play On April 15, 2010 – Safe Chemicals Act of 2010 (S. 3209) – Toxic Chemicals Safety Act of 2010 (House discussion draft) – Similar, not identical Would overhaul TSCA If passed, would directly impact – All manufacturers (including importers) of chemicals – All processors (including formulators) of chemicals

5. Prioritization EPA to establish a rolling Priority list of 300 chemicals for a safety determination Selection at EPA’s discretion Factors to consider: – Risk as compared to other chemicals – Presence in organisms and environment – Use – Production volume – Toxicity, persistence, bioaccumulation, etc.

6. Prioritization - Concerns Scope – all chemicals and mixtures are headed to the list Petition process to add – but not delete – from the list Lack of distinct focus on chemicals of highest concern in this process Notice and comment? Workability 6

7. Information on Chemicals Each manufacturer and processor must submit a declaration to EPA for each chemical it manufactures or processes that includes – Available health and environmental data – Where produced, volumes, uses, customers Within 5 years of enactment, EPA must: – Reset TSCA Inventory based on submitted declarations – Categorize all chemicals 7

8. Information on Chemicals EPA to identify a minimum data set for all chemicals – Hazard, exposure, use information EPA may require additional testing – By rule or order, identifying who must test – Hazard or exposure information, including biomonitoring Failure to submit minimum data set or testing as required can lead to prohibition of manufacturing/ processing

9. Minimum Data Set For new chemicals - submit minimum data set at time of premanufacture notification For existing chemicals - within 18 months after listing and must also submit additional information to show the chemical meets the safety standard

10. Minimum Data Set: New Uses of Existing Chemicals For new uses without a safety determination, must submit minimum data set prior to new use. For new uses with a prior safety determination, minimum data set must be updated prior to engaging in new use. New use of chemical with a prior safety determination triggers redetermination

11. Information and MDS – Concerns “New use/new chemicals” – stifle innovation Cost/benefit out of balance No explicit provision for varying required information based on toxicity or use/exposure Burden, especially given expansion of scope to mixtures and articles

12. Safety Determination If chemical does not meet the safety standard, no more manufacturing, processing, or distributing chemical No judicial review of a negative safety determination (Senate) Determination may include controls (bans, use and production restrictions) necessary for chemical to meet the safety standard. Critical use exceptions

13. Safety Standard (Senate) “Reasonable certainty of no harm” Means: – aggregate exposure and cumulative exposure – of the general population or of any vulnerable population – to the chemical or mixture – presents a negligible risk – of any adverse effect – on the general population or a vulnerable population

14. Safety Standard (House) Safety standard: -- takes into account aggregate and cumulative exposure -- to chemical substance or mixture -- and provides reasonable certainty of no harm -- including to vulnerable populations -- and protects public welfare -- from adverse effects -- including effects to environment

15. Safety Determination and Standard - Concerns No opportunity to comment on safety determinations No opportunity to comment on risk management controls Aggregate and cumulative exposure “No harm” standard “Any adverse effects”

16. Confidential Business Information No confidentiality protection for identity of existing chemicals Up-front substantiation of confidentiality claims required Confidentiality claims only last 5 years EPA can disclose CBI to states that take steps to protect it – Also foreign governments (House)

17. Other Provisions of Concern Preemption Elimination of regulatory exemptions – Polymers; low release/exposure Expedited Action Jurisdictional Lines Implementing International Conventions