# TSCA Overview for Chemical Safety Advisory Committee Jeff Morris, PhD, Deputy Director Office of Pollution Prevention and Toxics Office of Chemical Safety & Pollution Prevention 

### May 11, 20162 

# EPA Organization
Office of the Administrator Headquarters offices Regional offices Office of Administration & Resource Management Region 1/Boston Office of Air & Radiation Region 2/New York Office of Chemical Safety & Pollution Prevention (OCSPP) Region 3/Philadelphia Office of Chief Financial Officer Region 4/Atlanta Office of Enforcement & Compliance Assurance Region 5/Chicago Office of Environmental Information Region 6/Dallas Office of General Counsel Region 7/Kansas City Office of Inspector General Region 8/Denver Office of International & Tribal Affairs Region 9/San Francisco Office of Research & Development Region 10/Seattle Office of Solid Waste & Emergency Response Office of Water Office of Chemical Safety & Pollution Prevention3 

# Office of Chemical Safety and Pollution Prevention Office of Chemical Safety and Pollution Prevention Assistant Administrator Deputy Assistant Administrator Office of Pesticide Programs (OPP) • Biological and Economic Analysis Division • Biopesticides and Pollution Prevention Division • Health Effects Division • Field and External Affairs Division • Antimicrobials Division • Information Technology and Resources Management Division • Environmental Fate and Effects Division • Pesticide Re-evaluation Division • Registration Division Office of Pollution Prevention and Toxics (OPPT) • Chemical Control Division • Chemistry, Economics and Sustainable Strategies Division • Environmental Assistance Division • Information Management Division • National Program Chemicals Division • Risk Assessment Division • TRI Program Division Office of Science Coordination and Policy (OSCP) • Exposure Assessment Coordination and Policy Division

Office of Chemical Safety & Pollution Prevention http://www.epa.gov/oppt/pubs/opptdiv.htm4 

# OPPT Organization

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# Toxic Substances Control Act (TSCA) Covers new and existing chemicals and mixtures in commerce in the United States. Section 4. Testing by manufacturers and processors Section 5. Premanufacture notification for new chemicals Section 6. Control of new and existing chemicals and mixtures that present unreasonable risks Section 8. Information reporting and recordkeeping on new and existing chemicals and mixtures Section 9. Requires coordination with other Federal agencies Among others, food, drugs, cosmetics and pesticide substances generally are excluded from TSCA. Office of Chemical Safety & Pollution Prevention6 

## Other TSCA Provisions Section 7. Imminent Hazards Section 9. Relationship to Other Federal Laws Section 12(b). Export Notification Section 13. Import Certification Section 14. Disclosure of Data, Confidential Business Information Section 21. Citizen Petitions

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## National Program Chemicals Polychlorinated biphenyls (PCBs) : TSCA Section 6(e) - Manufacturing, Processing, Distribution in Commerce and Use Prohibitions. http://www3.epa.gov/epawaste/hazard/tsd/pcbs/index.htm 

### Mercury: Mercury Export Ban Act of 2008 • Amended TSCA section 6: To prohibit the sale, distribution, or transfer of elemental mercury by Federal Agencies effective upon enactment. • Amended TSCA section 12: Prohibits the export of elemental mercury beginning January 1, 2013 with allowances for essential use exemptions. http://www.epa.gov/mercury/

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## National Program Chemicals (continued ) Asbestos : TSCA Title II – The Asbestos Hazard Emergency Response Act (AHERA); EPA Asbestos Worker Protection Rule (Section 6) http://www.epa.gov/asbestos 

### Lead : TSCA Title IV – Residential Lead - Based Paint Hazard Reduction Act of 1992. Federal strategy for reducing lead paint exposure. http://www2.epa.gov/lead 

### Formaldehyde : TSCA Title VI – Formaldehyde Standards for Composite Wood Produc Establishes limits for formaldehyde emissions from composite wood products (hardwood plywood, medium density fiberboard, and particle board). EPA is in process of finalizing rule to implement Act. http://www.epa.gov/formaldehyde
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# TSCA Inventory

• TSCA section 8(b) requires EPA to compile, keep current and publish a list of each chemical substance that is manufactured or processed, including imports, in the U.S. for uses under TSCA. • Referred to as the “TSCA Inventory” - plays a central role in the regulation of chemical substances in the U.S. • Based on chemical manufacturer and processor reporting; was initially published in 1979, and a second version, containing about 62,000 chemical substances, was published in 1982. • When production commences of new chemical that has undergone PMN review, it is added to the inventory • Inventory now lists about 85,000 chemical substances.

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# TSCA
- New Chemicals Program

“New Chemicals”: Chemicals not on the TSCA Inventory 

### Under TSCA section 5(a), manufacturers, including importers, of new chemicals must submit a premanufacture notice (PMN) to EPA 90 days prior to manufacture/import. PMN Information: • Chemical identity • Use • Anticipated production volume • Exposure and release information • Only existing test data known to or reasonably ascertainable by the submitter Office of Chemical Safety & Pollution Prevention11 

# TSCA New Chemicals Program
• Pre- Manufacture Notices required in advance of manufacture or import. Includes available health and environmental data. • EPA has 90 days to complete review. • Unless EPA takes action to require additional data, restrict or regulate based on concerns, chemicals can enter commerce without further consideration • Since 1976, EPA has reviewed more than 38,000 new chemicals • Receive 1000 or so Pre- Manufacture Notices (PMNs) a year. • About half go on the market • Significant New Use Rule (SNUR) – requires notification and EPA reivew of new uses of “dead” chemicals 

### • Emerging technologies leading to new substances; e.g., Nanotechnology and Synthetic Biology Office of Chemical Safety & Pollution Prevention 1112 

# TSCA Existing Chemicals Program
• No statutory requirement to test, prioritize or address existing chemicals. • Requiring testing must be done through rulemaking and requires making specific findings. • Section 6 gives EPA authority to limit or ban chemicals which present “an unreasonable risk of injury to health or the environment.” • Procedural and analytical requirements have proven challenging; • Only six TSCA ban actions, including failed asbestos ban • Until this year, EPA has not attempted Section 6 action since the asbestos ban was largely remanded in 1991. 

### • Utilizing three- pronged approach to enhance TSCA Existing Chemicals Program
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## Three Pillars of EPA’s Existing Chemicals Program ❶ Risk Assessment and Reduction • Comprehensive assessment of highest priority chemicals with risk management, where appropriate 

### ❷ Increasing Access to Chemical Data • Providing data to users allows for more informed decision makers • Toxics Release Inventory 

### ❸ Promote the Design and Use of Safer Chemicals • Incentivize the development of safer chemicals and make it easier for consumers to find these options in the marketplace.

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# TSCA Section 6
• TSCA § 6(a) provides EPA with the authority to take a wide range of actions to reduce risks, including prohibiting or limiting the manufacture, processing, distribution in commerce, use or disposal of a chemical or mixture. • EPA must make certain findings before a § 6(a) rule may be finalized: • There is a reasonable basis to conclude that a chemical substance or mixture “presents or will present an unreasonable risk of injury to health or the environment.” • The regulatory option chosen is the least burdensome option that adequately protects against such risk. 

## • EPA’s rules under §6(a) may preempt state or local requirements designed to protect against the same risk from the same chemical. Office of Chemical Safety & Pollution Prevention 14 Internal - Deliberative15 

# Weighing Costs and Benefits of Chemical Regulation under TSCA Section 6

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### To learn more about TSCA and EPA’s Chemical Management & Pollution Prevention Programs: 

# http://www.epa.gov/oppt