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

Invitation to comment

24 April 2019

This consultation closes on 24 May 2019.

The following chemicals have been added to the proposals to amend the Poisons Standard, referred by the delegate of the Secretary of the Department of Health, to the June 2019 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) as late additions 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 these late additions to the scheduling proposals referred to the June 2019 meetings of the Advisory Committee on Chemicals Scheduling (ACCS #25). Submissions must be received by close of business 24 May 2019. See How to respond.

1. Proposed amendments referred for scheduling advice to ACCS #25

1.1 Lambda-cyhalothrin

1.1 Lambda-cyhalothrin

CAS Number

91465-08-6

Alternative names

3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethyl-cyano(3-phenoxyphenyl)methyl cyclopropane carboxylate, (R)-cyano(3-phenoxyphenyl)methyl (1S,3S)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propen-1-yl]-2,2-dimethylcyclopropanecarboxylate

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Proposed scheduling

To amend the Schedule 5 entry for lambda-cyhalothrin in the Poisons Standard as follows:

Schedule 7

LAMBDA-CYHALOTHRIN, except when included in Schedule 5 or 6.

Schedule 6

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 25 per cent or less of microencapsulated lambda-cyhalothrin; or
  2. in emulsifiable granule formulations containing 25 per cent or less lambda-cyhalothrin; or
  3. in other preparations containing 1.6 per cent or less of lambda-cyhalothrin

except when included in Schedule 5.

Schedule 5 - Amend Entry

LAMBDA-CYHALOTHRIN:

  1. in aqueous preparations containing 1 per cent or less of lambda-cyhalothrin; or
  2. in aqueous preparations containing 2.5 4 per cent or less of microencapsulated lambda-cyhalothrin.

Index

LAMBDA-CYHALOTHRIN

Schedule 7

Schedule 6

Schedule 5

Key uses / expected use

Insecticide

Reasons for proposal

Acute toxicity of the formulated product meets the criteria stipulated in the Scheduling Policy Framework, with the exception of the estimated acute oral toxicity, which was determined based on the up-and-down method.

1.2 Sarolaner

1.2 Sarolaner

CAS Number

1398609-39-6

Alternative names

IUPAC Name: Ethanone, 1-[5'-[(5S)-5-(3,5-dichloro-4-fluorophenyl)-5(trifluoromethyl)-4,5-dihydro- 1,2-oxazol-3-yl]-3'H)-spiro[azetidine3,1'-[2]benzofuran]-1-yl]-2-methanesulfonylethan-1-one.

Other names: PF-6450567; 1-(5'-((5S)-5-(3,5-dichloro-4-fluorophenyl)-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl)spiro(azetidine-3,1'(3'H)-isobenzofuran)-1-yl)-2-(methylsulfonyl)-ethanone.

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Proposed scheduling

To amend the Schedule 5 entry for sarolaner in the Poisons Standard as follows:

Schedule 6

SAROLANER except when included in Schedule 5.

Schedule 5 - Amend Entry

SAROLANER in veterinary preparations for the treatment, prevention and control of fleas and ticks in dogs in oral divided preparations each containing 120 mg or less of sarolaner per dosage unit.

Index

SAROLANER

Schedule 6

Schedule 5

Key uses / expected use

Veterinary medicine

Reasons for proposal

The spot-on product line for cats, containing 60 mg/mL selamectin plus 10 mg/mL sarolaner has a significantly reduced acute oral toxicity to sarolaner per se which, together with other acute toxicity endpoints for sarolaner, does not meet the Scheduling Policy Framework criteria for Schedule 6.

1.3 Broflanilide

1.3 Broflanilide

CAS Number

1207727-04-5

Alternative names

3-(benzomethylamino)-N-[2-bromo-4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl)-6-(trifluoromethyl)phenyl]-2-fluorobenzamide (CAS), N-[2-bromo-4-(perfluropropan-2-yl)-6-(trifluormethyl)phenyl]-2-fluoro-3-(N-methylbenzamido)benzamide (IUPAC)

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Proposed scheduling

To include broflanilide as a new entry in the Poisons Standard as follows:

Schedule 6 - New Entry

BROFLANILIDE, except when included in Schedule 5.

Schedule 5 - New Entry

BROFLANILIDE, in preparations containing 3 per cent or less of broflanilide.

Key uses / expected use

Insecticide

Reasons for proposal

This cut-off is considered appropriate based on the clear thresholds below which no effects are observed. All proposed products would be captured by this Schedule 5 entry.

1.4 Trifludimoxazin

1.4 Trifludimoxazin

CAS Number

1220411-29-9

Alternative names

1,5-dimethyl-6-thioxo-3-[2,2,7-trifluoro-3-oxo-4-(prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]-1,3,5-triazinane-2,4-dione (IUPAC), Dihydro-1,5-dimethyl-6-thioxo-3-[2,2,7-trifluoro-3,4-dihydro-3-oxo-4-(2-propyn-1-yl)-2H-1,4-benzoxazin-6-yl]-1,3,5-triazine-2,4(1H,3H)-dione (CAS)

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Proposed scheduling

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

Appendix B, Part 3 - New Entry
Substance Date of entry Reason for listing Area of use
TRIFLUDIMOXAZIN [TBD] a 1.1
Key uses / expected use

Agricultural herbicide

Reasons for proposal

The toxicology profile is well characterised for this agricultural herbicide. There is low acute toxicity at the highest tested dose. The product is not intended to be used in the home garden, with intended uses limited to the agricultural sector. Due to the low toxicity, no personal protective equipment was required during use of the product.

1.5 Saflufenacil

1.5 Saflufenacil

CAS Number

372137-35-4

Alternative names

2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide (CAS), N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)benzoyl]-N-isopropyl-N-methylsulfamide (IUPAC)

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Proposed scheduling

To amend the Schedule 5 entry for saflufenacil in the Poisons Standard as follows:

SAFLUFENACIL except when included in Schedule 5.

Schedule 5 - Amend Entry

SAFLUFENACIL in water dispersible granules preparations. or a water-based suspension concentrate.

Index

SAFLUFENACIL

Schedule 7

Schedule 5

Key uses / expected use

Agricultural herbicide

Reasons for proposal

The restriction of the current Schedule 5 entry to wettable granule formulations was based on data from a dermal absorption study with a suspension concentrate formulation. It is proposed that this formulation is added to the Schedule 5 entry.

How to respond

Submissions must:

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 cover sheet (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 12 September 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 (please complete the cover sheet, see How to respond).
  • 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).