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, 2016
EPA Organization 2

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 Prevention
Office of Chemical Safety and Pollution Prevention 3

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

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

Office of Chemical Safety & Pollution Prevention
7 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/

Office of Chemical Safety & Pollution Prevention
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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 ProducEstablishes 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

Office of Chemical Safety & Pollution Prevention
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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 Prevention
11 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

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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.

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Internal - Deliberative
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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