Many nanoscale materials are regarded as "chemical substances" under the Toxic Substances Control Act (TSCA). To ensure that nanoscale materials are manufactured and used in a manner that protects against unreasonable risks to human health and the environment, EPA is pursuing a comprehensive regulatory approach under TSCA. This four-pronged approach includes:
Premanufacture notifications; a Significant New Use Rule; an information gathering rule; and a test rule.
Since 2005, EPA has received and reviewed over 100 new chemical notices under TSCA for nanoscale materials, including carbon nanotubes, and that number will increase over time. The Agency has taken a number of actions to control and limit exposures to these chemicals, including:
* limiting the uses of the nanoscale materials,
* requiring the use of personal protective equipment, such as impervious gloves and NIOSH approved respirators,
* limiting environmental releases, and
* requiring testing to generate health and environmental effects data.
he Agency has also allowed the manufacture of new chemical nanoscale materials under the terms of certain regulatory exemptions, but only in circumstances where exposures were tightly controlled to protect against unreasonable risks.
The Agency is developing a SNUR under section 5(a)(2) of TSCA to ensure that nanoscale materials receive appropriate regulatory review. The SNUR would require persons who intend to manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to submit a SNUR to EPA at least 90 days before commencing that activity.
The SNUR (Siginificant New Use Rules)would identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary NMSP (Nano scale stewardship programm)and other information.
The SNUNs would provide the Agency with a basic set of information on nanoscale materials, such as chemical identification, material characterization, physical/chemical properties, commercial uses, production volume, exposure and fate data, and toxicity data. This information would help the Agency evaluate the intended uses of these nanoscale materials and to take action to prohibit or limit activities that may present an unreasonable risk to human health or the environment.
Fully understanding the environmental applications and implications of nanotechnology requires the concerted efforts of scientists and policy makers across the globe. EPA is working collaboratively with stakeholders both domestically and internationally to address nanoscale materials, to identify and address nanotechnology research needs, and to develop international standards for nanotechnology.
International organizations such as the International Organization for Standardization (ISO) and the Organization for Economic Cooperation and Development (OECD) are engaged in nanotechnology issues.
EPA is actively participating in the Working Party and contributes to all of the projects which help leverage international expertise and resources. The project on Safety Testing of a Representative Set of Manufactured Nanomaterials, in particular, will help address important data gaps. The WPMN has identified a representative list of manufactured nanoscale materials for environmental health and safety testing, including:
* fullerenes (C60)
* single-walled carbon nanotubes (SWCNTs)
* multi-walled carbon nanotubes (MWCNTs)
* silver nanoparticles
* iron nanoparticles
* carbon black
* titanium dioxide
* aluminum oxide
* cerium oxide
* zinc oxide
* silicon dioxide
* polystyrene
* dendrimers
* nanoclays
The WPMN has also published a list of testing endpoints in the following areas:
* nanomaterial information/identification
* physical-chemical properties
* material characterization
* environmental fate
* environmental toxicology
* mammalian toxicology
* material safety
A number of countries and organizations are sponsoring testing. EPA is sponsoring environmental effects and fate testing of fullerenes, single-walled carbon nanotubes, multi-walled carbon nanotubes, silver nanoparticles, and cerium oxide. The United States is also contributing testing for iron, carbon black, titanium dioxide, aluminum oxide, and dendrimers. The outcome of this and other OECD projects will contribute to EPA's efforts to enhance its regulatory oversight of nanoscale materials.
Premanufacture notifications; a Significant New Use Rule; an information gathering rule; and a test rule.
Since 2005, EPA has received and reviewed over 100 new chemical notices under TSCA for nanoscale materials, including carbon nanotubes, and that number will increase over time. The Agency has taken a number of actions to control and limit exposures to these chemicals, including:
* limiting the uses of the nanoscale materials,
* requiring the use of personal protective equipment, such as impervious gloves and NIOSH approved respirators,
* limiting environmental releases, and
* requiring testing to generate health and environmental effects data.
he Agency has also allowed the manufacture of new chemical nanoscale materials under the terms of certain regulatory exemptions, but only in circumstances where exposures were tightly controlled to protect against unreasonable risks.
The Agency is developing a SNUR under section 5(a)(2) of TSCA to ensure that nanoscale materials receive appropriate regulatory review. The SNUR would require persons who intend to manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA Inventory to submit a SNUR to EPA at least 90 days before commencing that activity.
The SNUR (Siginificant New Use Rules)would identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary NMSP (Nano scale stewardship programm)and other information.
The SNUNs would provide the Agency with a basic set of information on nanoscale materials, such as chemical identification, material characterization, physical/chemical properties, commercial uses, production volume, exposure and fate data, and toxicity data. This information would help the Agency evaluate the intended uses of these nanoscale materials and to take action to prohibit or limit activities that may present an unreasonable risk to human health or the environment.
Fully understanding the environmental applications and implications of nanotechnology requires the concerted efforts of scientists and policy makers across the globe. EPA is working collaboratively with stakeholders both domestically and internationally to address nanoscale materials, to identify and address nanotechnology research needs, and to develop international standards for nanotechnology.
International organizations such as the International Organization for Standardization (ISO) and the Organization for Economic Cooperation and Development (OECD) are engaged in nanotechnology issues.
EPA is actively participating in the Working Party and contributes to all of the projects which help leverage international expertise and resources. The project on Safety Testing of a Representative Set of Manufactured Nanomaterials, in particular, will help address important data gaps. The WPMN has identified a representative list of manufactured nanoscale materials for environmental health and safety testing, including:
* fullerenes (C60)
* single-walled carbon nanotubes (SWCNTs)
* multi-walled carbon nanotubes (MWCNTs)
* silver nanoparticles
* iron nanoparticles
* carbon black
* titanium dioxide
* aluminum oxide
* cerium oxide
* zinc oxide
* silicon dioxide
* polystyrene
* dendrimers
* nanoclays
The WPMN has also published a list of testing endpoints in the following areas:
* nanomaterial information/identification
* physical-chemical properties
* material characterization
* environmental fate
* environmental toxicology
* mammalian toxicology
* material safety
A number of countries and organizations are sponsoring testing. EPA is sponsoring environmental effects and fate testing of fullerenes, single-walled carbon nanotubes, multi-walled carbon nanotubes, silver nanoparticles, and cerium oxide. The United States is also contributing testing for iron, carbon black, titanium dioxide, aluminum oxide, and dendrimers. The outcome of this and other OECD projects will contribute to EPA's efforts to enhance its regulatory oversight of nanoscale materials.
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