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Underlying Foundation of Science used in Regulation of Industrial Chemicals
Smithers Information Ltd, April 2009, Pages: 136
Underlying Foundation of Science used in Regulation of Industrial Chemicals reviews the relevant chemical nomenclature issues in the EU and in the US and their impact on regulatory compliance. In particular, during the pre-REACH period, chemical identities frequently were described differently by different manufacturers for the same chemicals.
The importance of having consistent nomenclature rules under REACH is related to the establishment of Substance Information Exchange Forums (SIEF) by ECHA after the pre-registration process, and, ultimately, industry consortia to meet registration requirements. If consistency is not established, there is a substantial risk that multiple registrations for the same substance will occur in conflict with the "One Substance, One Registration" (OSOR) principle under REACH.
Underlying Foundation of Science used in Regulation of Industrial Chemicals discusses the relationships between and among various nomenclature systems and how chemical identity issues are to be addressed under REACH, along with comparative examples of chemical issues under TSCA in the US.
Chemical identity issues are of central importance to the successful implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), both for the regulated community and for the European Chemical Agency (ECHA) responsible for REACH's implementation.
A variety of nomenclature systems exists, some with similar naming convention but also with critically important differences. These systems include: International Union of Pure and Applied Chemistry (IUPAC) which is used in European Union (EU) countries and that provides the primary nomenclature system to be used in the implementation of REACH; Chemical Abstracts Services Registry Names and Numbers (CASRN), which is used in the United States and Canada, and will be used as an adjunct to IUPAC under REACH; common names and trade names; and the use of SMILES (Simplified Molecular Input Line Entry System) notation designed for computer use by chemists.
Introduction: Importance of Science in the Implementation of TSCA and REACH-Chemical Identity and Risk Assessment
- Hazard Assessment
- Exposure Assessment
- Risk Assessment in Practice
- Risk Assessment under the TSCA
- Risk Assessment under REACH
International Conventions for Naming Chemicals
- IUPAC Naming Conventions
- CAS Naming Conventions and CASRN
-- CAS Registry
-- CASRN and the TSCA Inventory
- SMILES Notation
- Multiple Names for One Common Substance: Ethyl Acrylate
Nomenclature Problems under TSCA
- Exemptions from the Definition of 'Chemical Substance'
- Scope of 'Persons' Subject to TSCA
- 'Iso' and 'Branched' Modifiers to Alkyl Group Descriptors
- Alkyl Range Descriptors
-- Natural Source Descriptions
-- SDA Identification
-- Non-SDA Alkyl-Range Descriptions
- Chemistry of Nonylphenol and Nonylphenol Derivatives
-- Historical Perspective
-- Chemical Identity of Nonylphenol: Alkylation of Phenol with Propylene Trimer
- Naturally Occurring and Minimally Processed Substances
- Inorganic Chemical Nomenclature Issues
-- Silica Nomenclature
-- Inorganic Glasses, Ceramics, and Frits
Technical Guidance Document: Substance Identification and Naming in REACH
- The Basics: What is a Substance?
- Guidance for well-defined and poorly-defined Substances
-- Well-Defined Substances
-- Poorly Defined Substances or of Variable Composition
- Section 7 of the TGD: Examples of Complex Product Registration Issues
- Section 8 of the TGD: Description of Substances in IUCLID 5
Polymer Definitions, Naming Conventions, and Regulatory Consequences under TSCA & REACH
- Polymer Definitions and Other Considerations under TSCA
-- Polymer Definitions and CAS Naming Conventions under the TSCA
--- Polymer Definition
--- Polymer Reactant and SRU Naming Conventions
-- The Two-Percent Rule: Used versus Incorporated
-- Post-Polymerisation Treatment and Devolvement
-- Polymer Exemption under the TSCA
- Complex Polymer Naming Issues: The Epoxy Example
-- Common Raw Materials Used in Epoxy Manufacture
-- Use of Common Raw Material to Make Epoxy Polymers with Different CAS Names
- Polymer Requirements and Confidentiality Issues under REACH
-- Polymer Definition under REACH and the 'No Longer Polymer' List
-- Polymer Confidentiality Issues under REACH
--- Pre-registration and Registration of Polymers: The Acrylate Example
--- Approaches to Monomer Registration and Protecting CBI
-- Legal Challenge to the Monomer Registration Requirement
- Regulation of Polymers in Canada: A Different Perspective
Treatment of Nanotechnology under TSCA and REACH
- Chemical Identity Issues: EPA's Dilemma
- Determination of Whether a Chemical Substance Is New or Existing
- Assessing the Risk of Nanoparticles
- Regulation of Nanoparticles under the TSCA
-- Carbon Nanotubes (CNT) As New Substances
-- SNUR for Nanomaterials
- Regulation of Nanoparticles under REACH
Summary and Future of the Science and Regulation of Chemicals
- Regulation of Nanotechnology and Lessons Learned from the TSCA
- Regulation of Polymers
Dr. Plamondon has had a long and distinguished career, and is well known in the chemical community. He brings a wealth of experience from his prior positions in industry with Rohm and Haas Company and Akzo Nobel. In addition to his work within the chemical industry, he has spent over ten years consulting with chemical companies on a broad range of TSCA issues, and he is currently a Senior Scientist at the law firm of Bergeson & Campbell, P.C. and its consulting affiliate The Acta Group, L.L.C.
Dr. Plamondon has made TSCA presentations at many conferences and professional meetings, e.g., the American Chemistry Council's Global Chemical Regulations Conference (Living with TSCA), among others, and has written extensively on chemical regulatory matters.
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