Summary of EPA's Proposed Rule for Nanoscale Substances

EPA’s Proposed TSCA Rule for Information Collection on Chemical Substances When Manufactured or Processed at the Nanoscale

Deadline for comment: July 6, 2015 

Statutory authority: Section 8(a) of TSCA, 40 C.F.R. Part 704

Overview

• EPA is proposing to collect information from companies that have manufactured, imported, or processed chemical substances at the nanoscale in the three years prior to the effective date of the rule.  Reports are due 6 months from the effective date of the rule. 
• EPA also is proposing to establish a permanent program of premanufacture reporting for companies who will manufacture, import, or process discrete forms of new or existing reportable substances for the first time after the effective date of the rule.  Reports will be due 135 days prior to engaging in non-exempt commercial activity.
• Information on chemical identity, physical chemical properties, impurities, byproducts, production, use, disposal and exposure needs to be submitted.
• Small manufacturers and processors are exempt from reporting if total annual sales, including parent company, are <$4 million.

Scope

• A “reportable chemical substance" is a “solid at 25°C and atmospheric pressure that is manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm and exhibit unique and novel characteristics or properties because of their size” and discrete forms of these substances.
• A discrete form is different due to:
  • A change in size and one or more of the following properties:  zeta potential, specific surface area, dispersion stability, or surface reactivity.  The changes in size and property have to be greater than 7 times the standard deviation of the measured value for the already reported form.
  • A change in morphology (shape). 
  • Use of a different coating on the same reportable chemical substance.

Excluded from Reporting

• Zinc oxide and nanoclays.
• Chemical substances manufactured at the nanoscale as part of a film on a surface.
• DNA, RNA, proteins.
• Chemical substances which disassociate completely in water to form ions smaller than 1 nm.
• Chemical substances for which EPA has received a premanufacture notification (PMN), significant new use notification (SNUN), or low volume/low exposure submission (LVE/LoREX) on or after January 1, 2005.
• Information that has been submitted to the Nanoscale Materials Stewardship Program does not need to be re-submitted if it is for the same discrete form.

Information EPA Proposes to Require

• Common name, trade name, specific chemical identity by Chemical Abstracts Index Name,  Chemical Abstracts Service (CAS) Registry Number, and molecular structure.
• Material characteristics including particle size, morphology, and surface modifications.
• Physical and chemical properties.
• Maximum weight percentage of impurities and byproducts resulting from manufacture, processing, use or disposal.
• Annual production volume for prior three years and an estimate of the maximum 12-month production volume during the next two years.  If a discrete form of the reportable chemical substance is first manufactured or processed after the effective date of the rule, EPA wants an estimate of the maximum 12-month production volume in the first three years of production.
• Use information by category, function, and application, estimates of the amount manufactured and processed for each category of use, and an estimate of the percentage in the formulation for each use.
• Detailed methods of manufacturing or processing.
• Exposure information with estimates of the number of individuals exposed in their places of employment, descriptions and duration of occupational tasks, and descriptions and estimates of any general population or consumer exposures.
• Release information with estimates of the amounts released, a description and the duration of the activities that cause the releases to occur, and whether the releases are directly to the environment or to control technology. 
• Risk management practices describing personal protective equipment (PPE), engineering controls, control technologies used, any hazard warning statement, label, safety data sheet, customer training, and other information provided to persons who are reasonably likely to be exposed to the substance regarding PPE, safe handling, transport, use or disposal.
• Existing data concerning environmental and health effects.