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Consultation: Proposed amendments to the Poisons Standard - Joint ACCS/ACMS meetings, March 2020

6 January 2020

This consultation closed on 10 February 2020.

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 scheduling proposals referred to the March 2020 meeting of the Joint Advisory Committee on Medicines and Chemicals Scheduling (Joint ACMS-ACCS #24).

Submissions must be received by close of business 10 February 2020. See How to respond.

Note

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1. Proposed amendments referred for scheduling advice to the Joint ACMS-ACCS #24

Definition of marker dyes and pigments in Part 1 of the Poisons Standard

Applicant

Delegate of the Secretary of the Department of Health

Current scheduling

The definition of markers dyes and pigments has not been previously considered.

Proposed scheduling

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

Part 1 of the Poisons Standard, Interpretation - New Entry

"Marker dyes or pigments" means any substance used to temporarily impart colour to:

  1. an agricultural product intended for spot- or boom -spraying to detect missed spots or to avoid spraying a plant or area multiple times; or
  2. a veterinary product for the purpose of identifying treated or selected animals.

Key uses/expected use

Veterinary and agriculture use

Reasons for proposal

  • Marker dyes or pigments are added to colour an agricultural or veterinary product for the purpose of identifying where that product has been applied.
  • As of October 2019 there are 47 products sold as marker dyes registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA). All of the registered products are marketed purely as marker dyes, and may be primarily used to assist in the identification of treated plants or areas, and in the case of animal products, to identify treated or selected animals.
  • There is a lack of clarity regarding the scheduling of markers dyes used in the agricultural and veterinary industry. This relates, in particular, to whether such marker dyes can be covered under the definition of paints or tinters. These substances (often grandfathered from State and Territories prior to the creation of the National Registration Authority for Agricultural and Veterinary Chemicals (NRA)/APVMA) may be available in a concentrated form before being added to other products e.g. herbicides and parasiticides. They will be present at dilute concentrations in the finale prepared product and have no other effect than to colour the primary product to aid users in identifying which surfaces (plant or animal) have been sprayed.
  • The Poisons Standard currently includes reference to 'hair dye' products; 'dyeing of eye lashes and eyebrows', 'azo dyes' and a number of dyes which are specifically named e.g. basic orange 31. There is currently no explicit definition for 'hair dyes' or 'dyeing' in Part 1 of the Standard.
  • The current proposal does not seek to exempt 'marker dyes and pigments' from scheduling. The creation of a new definition does not alter any current substance entries in the Poisons Standard. The intention of this proposal is not to capture 'inks' or 'ink additives'; 'skin colouring or colouration' products including those used in tattooing; dyes used by the general public to changing the colour of clothing, hair, etc; or colours used in food and beverages.
  • In making creating this proposal, the Delegate took into account the APVMA definition for dyes which are described as 'commonly used for spot- or boom -spraying herbicides to detect missed spots or avoid spraying a plant or area twice)'.[1]
  • The Delegate also considered the majority view in the advice provided by the Advisory Committee on Chemicals Scheduling provided in October 2019, that the existing definitions for 'tinter' and 'paint' in Part 1 of the Poisons Standard are distinct from marker dyes.
  • The applicability of the proposed definition to existing and/or new marker dye or pigment products are subject to a separate consideration under an amendment to the Poisons Standard.

Australian regulations

  • As of October 2019, there are 47 products sold as marker dyes registered with the Australian Pesticides and Veterinary Medicines Authority (APVMA). The approved uses include:
    • agriculture (36 registered products);
    • veterinary medicine (10 registered products); and
    • veterinary pesticide (1 registered product).
  • With respect to the APVMA registered products, the constituents include:
Use Active constituents Other constituents Scheduling status of APVMA registered products

Agricultural

rhodamine B

rhodamine

sulphonated aromatic acid dye

CI acid blue 9, disodium salt (hidacid azure blue 65%)

direct red 254

acid blue 9 liquid

sodium alkyl ether sulfate

1-dodecanol

blue colourant

sodium lauryl ether sulfate

fatty alcohol

sodium alkyl ether sulfate

diethylene glycol

diethylene glycol monobutyl ether

Schedule 6: 2

(product IDs: 86463, 67770)

Schedule 5: 1

(product ID: 57913)

Unscheduled:33

Veterinary medicine

oestradiol benzoate

progesterone

testosterone propionate

oestradiol benzoate

trenbolone acetate

oestradiol 17 beta

zeranol

ortho-dichlorobenzene

hydrocarbon liquid

detectable marker

Schedule 6: 5 (product IDs: 53869, 49955, 49954, 47311, 47248)

Schedule 5: 5

(product IDs: 53269, 49956, 49620, 48945, 46111)

Unscheduled: 0

Veterinary pesticide

Nil identified

hydrocarbon liquid

Schedule 5: 1

(product IDs: 53270)

Unscheduled: 0

  • The APVMA definition for dyes is as follows 'commonly used for spot- or boom -spraying herbicides to detect missed spots or avoid spraying a plant or area twice'.
  • According to the guidelines for the registration of agricultural adjuvant products, marker dyes are considered as adjuvants and when added to the pesticide product, they must not unduly affect the crop.[2]

International regulations

  • According to the United States (US) Environmental Protection Agency (EPA), there is not a separate registration category for marker dyes. A number of dyes are included in the EPA approved list for inert ingredients, and these can be included in pesticides at low levels. Other dyes are available and can be added to pesticides however do not appear to be registered as pesticides.
  • The European Union and Canada do not separately register marker dyes.


How to respond

Submissions must:

  • be relevant to the proposed amendment;
  • address matters mentioned in section 52E of the Therapeutic Goods Act 1989;
  • submitted by the closing date of 10 February 2020 to medicines.scheduling@health.gov.au for substances referred to the ACMS or Joint ACMS-ACCS, or chemicals.scheduling@health.gov.au for substances referred to the ACCS. (Please include 'Proposed Amendments to the Poisons Standard (Medicines/Chemicals)' in the subject line of the email);
  • include whether or not you support the amendment/s; and
  • be accompanied by a completed TGA Consultation submission coversheet.

Submissions might also include:

  • Suggested improvements; and/or
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

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 10 June 2020.

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 (please complete the coversheet, see How to respond above).
  • 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).