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Consultation: Proposed amendments to the Poisons Standard - ACCS meeting, March 2019

Invitation to comment

10 January 2019

This consultation closed on 8 February 2019.

MCPB has been added to the proposals to amend the Poisons Standard, referred by the delegate of the Secretary to the Department of Health, to the March 2019 meeting of the Advisory Committees on Chemicals Scheduling (ACCS) as a late addition to the agenda.

Scheduling amendments referred to expert advisory committee

Subdivision 3D.2 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides to refer the proposed amendment to an expert advisory committee. These include, under regulation 42ZCZK, that the Secretary publish (in a manner the Secretary considers appropriate) the proposed amendment to be referred to an expert advisory committee, the committee to which the proposed amendment will be referred, and the date of the committee meeting. The Secretary must also invite public submissions to be made to the expert advisory committee by a date mentioned in the notice as the closing date, allowing at least 20 business days after publication of the notice.

In accordance with regulation 42ZCZK of the Regulations, the Secretary invites public submissions on this late addition to the scheduling proposals referred to the March 2019 meetings of the Advisory Committee on Chemicals Scheduling (ACCS #24).

Submissions must be received by close of business 8 February 2019.

Proposed amendments referred for scheduling advice to ACCS #24

2.3 MCPB

2.3 MCPB

CAS Number:

94-81-5

Alternative names

4-(4-chloro-o-tolyloxy)butyric acid (IUPAC)

Applicant

Private applicant

Current scheduling

MCPB is currently listed in Schedule 5 of the Poisons Standard as follows:

Schedule 5

MCPB

Index

MCPB

Schedule 5

Proposed scheduling

It has been proposed to amend the Poisons Standard as follows:

Schedule 5 - Delete Entry

MCPB

Schedule 6 - New Entry

MCPB

Index - Amend Entry

Schedule 5

Schedule 6

Key uses / expected use

Agriculture

Reasons for proposal

Potential for salts of MCPB in a herbicide product to cause irreversible eye (corneal) damage. MCPB acid, and one form of MCPB salt have been shown to be moderately acutely toxic via the oral route.

What will happen

All public submissions will be published on the TGA website at Public submissions on scheduling matters, unless marked confidential or indicated otherwise in the submission coversheet (see Privacy information).

Following consideration of public submissions received before the closing date and advice from the expert advisory committee/s, decisions on the proposed amendments will be published as interim decisions on the TGA website: Scheduling delegate's interim decisions & invitations for further comment on 6 June 2019.

Privacy and your personal information

  • The TGA collects your personal information in this submission in order to:
    • Contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • Help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
  • The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site.
  • Any text within the body of your submission that you want to remain confidential should be clearly marked ‘IN CONFIDENCE’ and highlighted in grey.
  • Please note that the TGA will not publish personal information about you/others without your/their consent unless authorised or required by law.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.

Enquiries

Any questions relating to submissions should be directed by email to medicines.scheduling@health.gov.au (for substances referred to the ACMS or Joint ACCS-ACMS) or chemicals.scheduling@health.gov.au (for substances referred to the ACCS).