biobased chemicals and the toxic substances control act ... · unsaturated trialkyl glyceride and...

© 2015 Bergeson & Campbell, PC. All Rights Reserved.

Richard E. Engler, Ph.D. Bergeson & Campbell, P.C. Washington, D.C. www.lawbc.com

Biobased Chemica ls and the Tox ic Subs tances Cont ro l Ac t Th ings Every B iobased Producer Needs to Know

Advanced Bioeconomy Leadership Conference 2015 Government Agency Outlooks and Updates

© 2015 Bergeson & Campbell, PC. All Rights Reserved. 2

Requirements under TSCA

§  The Toxic Substances Control Act (TSCA) requires substances imported or manufactured to be listed on the TSCA Chemical Substances Inventory (TSCA Inventory)

§  TSCA substances: catch-all for uses not regulated by other statutes

§  If not listed, must notify the U.S. Environmental Protection Agency (EPA) via Premanufacture Notice (PMN)

§  TSCA is triggered by what you make and what you use it for


TSCA Nomenclature

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§  Single, defined substances (Class 1) are named and listed on the Inventory as such

§  Class 1 substances can be made by any means without changing the identity

§  For example: Ethanol can be made by fermentation using brewers yeast, an engineered microorganism, or addition of water to ethylene


§  Unknown or variable composition, complex reaction products, and biological materials (UVCB) are not single, defined substances (Class 2)

§  Class 2 substances are named with the source and/or process in the name or as part of the definition, which counts as part of the name

TSCA Nomenclature (cont’d)


Class 2 Substances §  Straight Run, Kerosene (petroleum)

Ø A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 180° C to 300° C (356° F to 572° F)


Class 2 Substances (cont’d) §  Corn oil

Ø Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic, and stearic (Zea mays)

§  Soybean oil Ø Extractives and their physically modified

derivatives. It consists primarily of the glycerides of the fatty acids linoleic, oleic, palmitic, and stearic (Soja hispida)


Class 2 Substances (cont’d) §  Vegetable oil

Ø Extractives and their physically modified derivatives. It consists primarily of the glycerides of the fatty acids arachidic, behenic, capric, lauric, .alpha.-licanic, eleostearic, eurcic, lignoceric, linoleic, linolenic, myristic, oleic, palmitic, ricinoleic, and stearic. (Mixed vegetable)


Feedstock Flexibi l i ty

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§  System to provide some flexibility on feedstocks: “Soap and Detergent Association (SDA) Nomenclature”

§  Categorizes surfactant supply chain substances into alkyl ranges and functional classes


§  Glycerides, C16-18 and C18-unsatd

Ø  This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00. Consult SDA Substance Identification Procedure

§  Fatty acids, C16-18 and C18-unsatd

Ø  This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid and SDA Reporting Number: 11-005-00. Consult SDA Substance Identification Procedure

SDA Nomenclature


SDA Nomenclature (cont’d) §  Fatty acids, C16-18 and C18-unsatd.,

compds. with diethanolamine

Ø  This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid diethanol amine salt and SDA Reporting Number: 11-006-13. Consult SDA Substance Identification Procedure

BUT…


Oils with fatty acids that may be called “C16-C18, C18 unsatd”

SDA Nomenclature Sources

“Alkyl groups derived from other natural sources are not covered by this procedure.”


SDA Nomenclature Identi t ies of Other Oi ls §  EPA position: Triglycerides from any

organism other than those 35 must be listed on the Inventory with the source as part of the name

§  The source is carried forward to the next step unless the proportion of fatty acids is changed


What Does This Mean? §  Each oil is listed separately; new oils require

notification

§  Each downstream product is listed separately; new products require notification

§  May throttle market for non-food oils as customers shy away from feedstocks requiring notification, or

§  May lead to dozens, or hundreds, of notifications for nearly identical substances as new organismal sources are brought to market


Possible Solut ions

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§  Biobased chemical company can refine triglycerides to specific chain lengths

§  After review of new triglyceride, allow use of SDA nomenclature (requires rulemaking)


§  Rare opportunity to influence TSCA reform:

Ø Ensure statutory authority for new nomenclature rules

Ø Empower EPA to make substantial equivalence decisions

Ø Harmonize rules with Europe

Consider TSCA Reform Measures


§  Stakeholders, like biobased chemical producers and their customers, need to be engaged

§  Consortium approach to inform EPA, point out need for change

Be Engaged!


Thank You Richard E. Engler, Ph.D.

BERGESON & CAMPBELL, P.C. 2200 Pennsylvania Avenue, N.W.

Suite 100W Washington, D.C. 20037

[email protected] www.lawbc.com

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biobased chemicals and the toxic substances control act ... · unsaturated trialkyl glyceride and...

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