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U.S. Environmental Protection Agency


Report Title: Certain New Chemicals; Receipt and Status Information
Report ID: 106
Date: 12/1/2008
Author: Chandler Sirmons, Acting Director, Information Management Division, Office of Pollution Prevention and Toxics
Report Type: Notice
Publication: Federal Registar, vol. 73, No. 240, December 12, 2008
Country: United States of America
Organization: U.S. Environmental Protection Agency
Summary: In this report, the Environmental Protection Agency (EPA) stated that Section 5 of the Toxic Substances Control Act (TSCA) requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. The EPA added that under sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish a notice of receipt of a premanufacture notice (PMN) or an application for a test marketing exemption (TME). It also must publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from November 3, 2008 through November 14, 2008, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this period.



Report Title: TSCA Inventory Status of Nanoscale Substances—General Approach
Report ID: 80
Date: 1/1/2008
Report Type: General Report
Country: United States of America
Organization: U.S. Environmental Protection Agency
Summary: In response to the rapid development of nanotechnology and introduction of nanoscale substances, the EPA issued this report stating it will maintain its previous evaluation process to determine whether nanomaterials are new chemicals. The EPA currently determines whether a substance is a “new” chemical according to the Toxic Substances Control Act (“TSCA”) by determining whether it has the same molecular identity as a substance already in the TSCA Inventory. If the chemical substance does not have an identical molecular identity to a substance on the TSCA Inventory, then it is considered a new chemical substance. The EPA considers chemical substances to have different molecular identities when they have any of the following: different molecular formulas, the same molecular formulas but have different atom connectivities, the same molecular formulas and atom connectivities but have different spatial arrangements of atoms, the same types of atoms but have different crystal lattices, different isotopes of the same elements, or are different allotropes of the same element. The EPA added that systematic chemical nomenclature conventions may not exist for all nanoscale substances identified as new chemicals, but the EPA is working on developing appropriate nomenclature conventions to meet these needs. Furthermore, any substance determined to be a “new” chemical is subject to the TSCA regulations before it may be manufactured or imported. However, the EPA may use different approaches when making regulatory stats determinations under its other authorities (e.g., the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)). However, in adopting this approach under TSCA, the EPA is not establishing a precedent on how nanotechnology issues arising under other EPA programs, other Federal Government agencies, or other federal statutes will be addressed. The EPA encouraged manufacturers and importers to contact the New Chemicals to program to determine whether their nanoscale substance is a new chemical. To help promote nanotechnology research, Italy has created four technology districts (TD) under the direction of the Association of Technology Districts (ADITE) in 2006. ADITE, along with various other public organizations, is working to increase funding opportunities and build up effective collaborations. Ecoffier concludes that these collaborations between public and private sectors have helped overcome the biggest hurdles in Italy's nanotechnology research and should be encouraged in the future. Finally, Ecoffier suggests that Italy's must increase their national initiative in order to better advance the country's nanotechnology research.



 
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