Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > Proposed Amendments to AICIS General Rules Include Clarifying Criteria for Industrial Chemicals Introduced at the Nanoscale
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Lynn L. Bergeson Managing Director Bergeson & Campbell, P.C. |
Abstract:
According to Australia, after the first year of operation of the Australian Industrial Chemicals Introduction Scheme (AICIS), the regulated industry and staff within the Office of Chemical Safety have identified "minor operational issues" that require amendments to the details set out in the Ministerial Rules.
August 25th, 2021
Proposed Amendments to AICIS General Rules Include Clarifying Criteria for Industrial Chemicals Introduced at the Nanoscale
According to Australia, after the first year of operation of the Australian Industrial Chemicals Introduction Scheme (AICIS), the regulated industry and staff within the Office of Chemical Safety have identified "minor operational issues" that require amendments to the details set out in the Ministerial Rules. Australia is proposing targeted amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019 that are intended to clarify the operation of the Ministerial Rules within existing policy. See https://www.industrialchemicals.gov.au/consultations/consultation-proposed-amendments-general-rules The proposed amendments address the following issues:
- Clarifying criteria for industrial chemicals introduced at the nanoscale;
- Declarations about data ownership;
- Annual declarations;
- Clarifying recordkeeping for listed introductions, specified classes, designated releases to the environment, and "internationally-assessed";
- The authorization process for movement of industrial chemicals into or out of Australia that are subject to the Rotterdam Convention; and
- Transitional provisions.
The consultation paper lists the following amendments regarding the requirements for industrial chemicals introduced at the nanoscale:
- Schedule 1, Clause 1 of the Exposure Draft: The proposed amendments are to the definition of specified classes of introductions, in particular to the criteria for introductions at the nanoscale. They would improve clarity for introducers on how these criteria apply in practice. (There is no actual change to criteria proposed.)
- Schedule 1, Clauses 2, 3, and 4 of the Exposure Draft: These proposed amendments are for research and development (R&D) introductions (nanoscale) in the exempted introduction category. They would improve clarity for introducers on how these criteria apply in practice. (There is no actual change to criteria proposed.)
- Schedule 1, Clause 5 of the Exposure Draft: These proposed amendments relate to non-functionalized surface treatment of listed chemicals in the exempted introduction category.
- Schedule 1, Clauses 6 and 7 of the Exposure Draft: The proposed amendments are for industrial chemicals introduced at a low volume solely for R&D in the reported introduction category.
- Schedule 1, Clauses 8, 9, and 10 of the Exposure Draft: The proposed amendments are for industrial chemicals introduced for R&D (other than nanoscale) in the reported introduction category.
- Schedule 1, Clauses 11 and 12 of the Exposure Draft: The proposed amendments clarify the nanoscale criteria for determining the indicative human health risk of an introduction.
- Schedule 1, Clauses 13 and 14 of the Exposure Draft: The proposed amendments clarify the nanoscale criteria for determining the indicative environmental risk of an introduction.
- Schedule 1, Clauses 15 and 16 of the Exposure Draft: The proposed amendments clarify the recordkeeping requirements related to the nanoscale criteria for exempted introductions introduced solely for R&D.
- Schedule 1, Clauses 15 and 16 of the Exposure Draft: The proposed amendments clarify the recordkeeping requirements related to the nanoscale criteria for reported introductions introduced solely for R&D.
The consultation paper lists the following amendments regarding the pre-introduction reporting requirements for industrial chemicals introduced at the nanoscale:
- Schedule 1, Clause 20 of the Exposure Draft: The proposed amendments clarify the pre-introduction reporting requirements related to the nanoscale criteria for reported introductions introduced solely for R&D.
- Schedule 1, Clause 21 of the Exposure Draft: The proposed amendments clarify the pre-introduction reporting requirements related to the nanoscale criteria for reported introductions where the highest indicative risk is low risk.
Comments are due September 17, 2021.
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