EPA's Proposed TSCA Rules for Nanoscale Materials
On April 6, 2015, the US Environmental Protection Agency proposed a new reporting/recordkeeping rule regarding nanoscale materials that are already in commerce. If finalized, the rule will require companies that manufacture or process chemicals at the nanoscale level to electronically report to US EPA information about the materials' chemical identity, production volume, methods of manufacture and processing, uses, exposure, and release data and available health and safety data.
The proposed rule is an attempt by EPA to gather information on nanomaterials that are already in commerce to determine if these materials require further regulation under the Toxic Substances Control Act (TSCA). In some cases, chemicals manufactured at the nanoscale have different properties—and pose different dangers to the environment—than those same chemicals manufactured at non-nanoscale levels. Properties that may vary based on size include the temperature at which it melts, how reactive it is, at what point it will fluoresce, and how mechanically strong or electric-conductive it is.
How Are Nanoscale Materials Used in Commerce?
Manufacturers use nanomaterials in a wide variety of products:
One of EPA's concerns is that nanomaterials may mobilize and react in the environment (air, soil, or water) faster and may create other problems that the same materials at larger scale would not pose. For instance, nanomaterials released to soil may be well absorbed and therefore immobile, but are small enough to fit between soil particles and so might travel farther before becoming trapped, enlarging areas of contamination (and thus increasing cleanup costs and liability). Read EPA's white paper on nanotechnology here.
How Are Nanomaterials Regulated Now Under TSCA?
Under the current TSCA chemical reporting and recordkeeping requirements, new nanomaterials are subject to the same Pre-Manufacture Notification (PMN) procedures as any other chemicals. In compliance with 40 CFR 720, manufacturers must submit a PMN to EPA 90 days prior to the date manufacture will commence. During this 90-day review period, EPA determines whether the chemical can be manufactured for distribution in the US. EPA has received hundreds of PMNs for nanomaterials since 2005. As with larger-scale chemicals, many nanomaterials become subject to either a TSCA §5(e) consent order or a Significant New Use Rule (SNUR), both of which limit or prohibit some or all of the substance's activities (manufacture, processing, distribution, use, or disposal).
Proposed rules are subject to a 90-day period of public comment. On July 2, EPA extended the public comment period on this proposed rule through August 5, 2015. Now that the period of public comment has closed, EPA will evaluate all comments and issue a final rule.
More details on EPA's ongoing nanomaterial research can be found here.
Convenient, Interactive TSCA Regulations Online Course
Be confident you know what you must report, record, and keep on file to meet your TSCA chemical reporting and recordkeeping requirements with the easy-to-use TSCA Regulations Online Course. Get up to speed with the latest rules and management requirements for chemical manufacturing, handling, storing, and processing chemical substances. Interactive, engaged online learning will prepare you to keep your business in compliance and avoid costly EPA civil penalties.
What Are Nanoscale Materials?
Nanoscale materials, or nanomaterials, are defined as those in the 1–100 nanometers (nm) size range. For perspective, a sheet of paper is 100,000 nm thick. A strand of human DNA is 2.5 nm in diameter.The proposed rule is an attempt by EPA to gather information on nanomaterials that are already in commerce to determine if these materials require further regulation under the Toxic Substances Control Act (TSCA). In some cases, chemicals manufactured at the nanoscale have different properties—and pose different dangers to the environment—than those same chemicals manufactured at non-nanoscale levels. Properties that may vary based on size include the temperature at which it melts, how reactive it is, at what point it will fluoresce, and how mechanically strong or electric-conductive it is.
How Are Nanoscale Materials Used in Commerce?
Manufacturers use nanomaterials in a wide variety of products:
- Nano silver is used in medical equipment, textiles, cosmetics, fabrics, and plastics.
- Carbon nanotubes are used in vehicles, sports equipment, coatings, plastics, and integrated circuits in electronics.
- Cerium dioxide is used in electronics, plastics, biomedical supplies, and fuel additives.
- Titanium dioxide is used in sunscreens, cosmetics, paints, and coatings.
- Nano iron is used to break down chlorinated hydrocarbons in hazardous waste sites.
- Micronized copper is used as a preservative in pressure-treated lumber.
One of EPA's concerns is that nanomaterials may mobilize and react in the environment (air, soil, or water) faster and may create other problems that the same materials at larger scale would not pose. For instance, nanomaterials released to soil may be well absorbed and therefore immobile, but are small enough to fit between soil particles and so might travel farther before becoming trapped, enlarging areas of contamination (and thus increasing cleanup costs and liability). Read EPA's white paper on nanotechnology here.
How Are Nanomaterials Regulated Now Under TSCA?
Under the current TSCA chemical reporting and recordkeeping requirements, new nanomaterials are subject to the same Pre-Manufacture Notification (PMN) procedures as any other chemicals. In compliance with 40 CFR 720, manufacturers must submit a PMN to EPA 90 days prior to the date manufacture will commence. During this 90-day review period, EPA determines whether the chemical can be manufactured for distribution in the US. EPA has received hundreds of PMNs for nanomaterials since 2005. As with larger-scale chemicals, many nanomaterials become subject to either a TSCA §5(e) consent order or a Significant New Use Rule (SNUR), both of which limit or prohibit some or all of the substance's activities (manufacture, processing, distribution, use, or disposal).
Proposed rules are subject to a 90-day period of public comment. On July 2, EPA extended the public comment period on this proposed rule through August 5, 2015. Now that the period of public comment has closed, EPA will evaluate all comments and issue a final rule.
More details on EPA's ongoing nanomaterial research can be found here.
Convenient, Interactive TSCA Regulations Online Course
Be confident you know what you must report, record, and keep on file to meet your TSCA chemical reporting and recordkeeping requirements with the easy-to-use TSCA Regulations Online Course. Get up to speed with the latest rules and management requirements for chemical manufacturing, handling, storing, and processing chemical substances. Interactive, engaged online learning will prepare you to keep your business in compliance and avoid costly EPA civil penalties.
Tags: EPA, new rules, reporting and recordkeeping, TSCA
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