Toxic Substances Control Act - The Here and Now of TSCA
Pacific Rim Summit on Industrial Biotechnology & Bioenergy San Diego, CA December 10, 2013
© 2013 Biobased and Renewable Products Advocacy Group. All Rights Reserved. © 2013 Biobased and Renewable Products Advocacy Group. All Rights Reserved.
Toxic Substances Control Act - The Here and Now of TSCA
Pacific Rim Summit on Industrial Biotechnology & Bioenergy San Diego, CA December 10, 2013
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Toxic Substances Control Act (TSCA)
• TSCA
• All chemicals (including renewables) in commerce » Unless subject to another regulation
© 2013 Biobased and Renewable Products Advocacy Group. All Rights Reserved.
• TSCA
• All chemicals (including renewables) in commerce » Unless subject to another regulation
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• $100,000+ penalties? • Production halted? • Tarnished reputation?
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TSCA and New Technologies
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HELP IS AVAILABLE
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Key TSCA Provisions
» NOTE: There are other important TSCA requirements not covered here
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• Inventory • Notification • Information Collection
» NOTE: There are other important TSCA requirements not covered here
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Inventory
TSCA Inventory
TSCA Inventory
status
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XI – Thou shall know thy product’s
TSCA Inventory
TSCA Inventory
» Statutory 90-day review period – But delays typical, so expect longer
– For renewables, delays can be considerably longer
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• Not listed on the Inventory? » Notify PRIOR to manufacture
» Statutory 90-day review period – But delays typical, so expect longer
– For renewables, delays can be considerably longer
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• Identify ALL materials manufactured or imported » Neat chemicals
» Mixtures
» Byproducts
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• Identify ALL materials manufactured or imported » Neat chemicals
» Mixtures
» Byproducts
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• Is the substance water or a naturally occurring substance?
» YES -- no CDR reporting needed Before you start celebrating….Processing restrictions for “naturally occurring”
• Is the substance a pesticide, tobacco, nuclear material, food additive, drug, cosmetic, or medical device?
» YES -- no CDR reporting needed
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• Is the substance water or a naturally occurring substance?
» YES -- no CDR reporting needed Before you start celebrating….Processing restrictions for “naturally occurring”
• Is the substance a pesticide, tobacco, nuclear material, food additive, drug, cosmetic, or medical device?
» YES -- no CDR reporting needed
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Determining Reportability for CDR (cont’d)
• Is the substance a polymer, microorganism, or certain form of natural gas?
» YES -- no CDR reporting needed UNLESS substance is subject to certain requirements
• Is the substance in question listed on the TSCA Inventory (public or confidential)? Public Inventory available at www.data.gov
» NO -- no CDR reporting needed
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• Is the substance a polymer, microorganism, or certain form of natural gas?
» YES -- no CDR reporting needed UNLESS substance is subject to certain requirements
• Is the substance in question listed on the TSCA Inventory (public or confidential)? Public Inventory available at www.data.gov
» NO -- no CDR reporting needed
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Summary Flowchart -- Always Check EPA Guidance to Confirm Reporting Obligations
Is the substance water or a naturally occurring substance?
• YES -- no CDR reporting needed
• NO -- go to next question
Is the substance a pesticide, tobacco, nuclear material, food additive, drug, cosmetic, or medical device? • YES -- no CDR reporting needed
• NO -- go to next question
• Is the substance a polymer, microorganism, or certain form of natural gas?
• YES -- no CDR reporting needed UNLESS substance is subject to certain requirements
• NO -- go to next question
© 2013 Biobased and Renewable Products Advocacy Group. All Rights Reserved.
• Is the substance a polymer, microorganism, or certain form of natural gas?
• YES -- no CDR reporting needed UNLESS substance is subject to certain requirements
• NO -- go to next question
• Is the substance in question listed on the TSCA Inventory (public or confidential)? Public Inventory available at www.data.gov
• NO -- no CDR reporting needed
• YES -- go to next question
Subject to potential reporting under CDR
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• Reporting Thresholds » 2,500 pounds for chemicals subject to certain TSCA rules/orders
(Sections 5, 6, 7)
• Per calendar year
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• Reporting Thresholds » 2,500 pounds for chemicals subject to certain TSCA rules/orders
(Sections 5, 6, 7)
• Per calendar year
• Industrial processing and use data » Type/function/sectors, number of downstream sites and workers,
production percentage per application
• Commercial use data » Sector codes, concentration, production percentage per use,
number of workers
• Consumer use data » Sector codes, concentration, production percentage per use,
used by children
© 2013 Biobased and Renewable Products Advocacy Group. All Rights Reserved.
• Industrial processing and use data » Type/function/sectors, number of downstream sites and workers,
production percentage per application
• Commercial use data » Sector codes, concentration, production percentage per use,
number of workers
• Consumer use data » Sector codes, concentration, production percentage per use,
used by children
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Exemptions from Part III Reporting
• Certain listed chemicals -- mainly petroleum process streams -- exempted from Part III reporting
• EPA time estimates to complete Form U » Parts I and II -- about 55 hours for single substance » Parts I, II, and III -- about 123 hours for single substance
• BRAG -- Works to get members’ biobased process streams exempted
© 2013 Biobased and Renewable Products Advocacy Group. All Rights Reserved.
• Certain listed chemicals -- mainly petroleum process streams -- exempted from Part III reporting
• EPA time estimates to complete Form U » Parts I and II -- about 55 hours for single substance » Parts I, II, and III -- about 123 hours for single substance
• BRAG -- Works to get members’ biobased process streams exempted
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• May or may not have commercial value
• Nonetheless produced for commercial advantage because it is part of the manufacture of a chemical product for a commercial purpose
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• Produced without separate commercial intent
• May or may not have commercial value
• Nonetheless produced for commercial advantage because it is part of the manufacture of a chemical product for a commercial purpose
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Characterization of Byproduct Reportable under CDR
• A mixture, composed of two or more well-defined chemical substances to be named and listed separately
• Multiple CAS Numbers
• Unknown or Variable composition, Complex reaction products and Biological materials (UVCB) = a reaction product to be listed as a single chemical substance, using one name that collectively describes the products or the reactants used to make the products
• Volumes of individual chemical components
• Single CAS number
© 2013 Biobased and Renewable Products Advocacy Group. All Rights Reserved.
• A mixture, composed of two or more well-defined chemical substances to be named and listed separately
• Multiple CAS Numbers
• Unknown or Variable composition, Complex reaction products and Biological materials (UVCB) = a reaction product to be listed as a single chemical substance, using one name that collectively describes the products or the reactants used to make the products
• Volumes of individual chemical components
• Single CAS number
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QUESTIONS?
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QUESTIONS?
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2200 Pennsylvania Avenue, N.W. Suite 100W
Washington, D.C. 20037 kroberts@bc-cm.com
www.bc-cm.com
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Kathleen M. Roberts B&C® CONSORTIA MANAGEMENT, L.L.C.
2200 Pennsylvania Avenue, N.W. Suite 100W
Washington, D.C. 20037 kroberts@bc-cm.com