• A prepublication version of a Toxic Substances Control Act (TSCA) Section 8(a) proposed rule was issued on March 25, 2015 by the U.S. Environmental Protection Agency (EPA). This rule would require manufacturers and processors of certain chemical substances at the nanoscale to report electronically to EPA specific information. The comment period will last for 90 days after the publication of the proposed rule in the Federal Register.

     

    With this proposal EPA aims to provide a useful guide to gathering necessary information on existing chemical substances manufactured at the nanoscale. This proposed rule contains criteria for defining which chemical substance is subject to reporting and which is excluded, and what information is required for future reporting.

     

    Which Chemical Substances subject to Proposed Rule

    You can make your comment on the proposed rule until July 6, 2015.

    The chemical substances which would subject to the proposed rule should be:

    • solid at 25 °C and atmospheric pressure
    • 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 because of their size.

    The chemical substances which contain only traces of primary particles, aggregates, or agglomerates in the size range of 1-100 nm and therefore do not exhibit the unique and novel characteristics or properties; they are not subjected to the rule.

    Food, food additive, drug, cosmetic, medical device and pesticide are not included to the proposed chemical substances, according to TSCA Section 3(2).

    The following substances are also excluded from the rule:

    • Zinc oxide
    • Nanoclays
    • Chemical substances manufactured at the nanoscale as part of a film on a surface
    • DNA
    • RNA
    • Proteins
    • Chemical substances which dissociate completely in water to form ions that are smaller than 1 nm

    Information to be Submitted

    EPA requires a one-time reporting of the following information:

    • Common trade name, specific chemical identity, and molecular structure of each chemical substance or mixture
    • Material characteristics, including particle size, morphology, and surface modifications
    • Physical/chemical properties
    • Maximum weight percentage of impurities and byproducts resulting from the manufacture, processing, use, or disposal of each chemical substance
    • Production volume information
    • Detailed methods of manufacturing or processing
    • Exposure information
    • Release information
    • Risk management practices
    • Existing data concerning the environmental and health effects

    During the comment period, EPA looks for public comment on the following issues:

    • Identifying the chemical substances that would be subject to reporting.

    EPA seeks comment in order to find out determine the chemical substances that would be subject to the reporting requirements of the rule.

    • Distinguishing between nanoscale forms of a reportable chemical substance.

    This should be based just on the behavior of the reportable chemical substance.

    • Reporting discrete forms at least 135 days before commencement of manufacture or processing.

    EPA seeks comment on whether this time-period should be 135 days as proposed, and why the time period is appropriate.

    • Considerations for EPA’s economic analysis.

    EPA is looking for information that would ease further evaluation of the potentially affected industry and firms.

    • Electronic reporting.

    With electronic reporting EPA enables potentially reporting entities to save time, improve data quality and increase efficiencies for both the submitters and the Agency.

    • Consideration of potential future rulemaking regarding periodic reporting.

    EPA wants to know whether it is possible to apply a future rule that would require periodic reporting of chemical substances manufactured at the nanoscale, similar to reporting that exists under the Chemical Data Reporting (CDR) rule.

    http://www.lawbc.com/regulatory-developments/entry/tsca-epa-proposes-reporting-and-recordkeeping-requirements-for-nanoscale-ma

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    This entry was posted on Monday, April 13th, 2015 By admin

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