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Consultation: Proposed amendments to the Poisons Standard - ACMS and ACCS, November 2019

Invitation to comment

29 August 2019

This consultation closes on 26 September 2019.

Note: In addition to the substances listed below, there will be up to five (5) additional substances referred to the November 2019 scheduling meetings. It is anticipated that invitation for public comment on these five substances will be published on the TGA website on 12 September 2019.

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 November 2019 meetings of the Advisory Committee on Medicines Scheduling (ACMS #28) and the Advisory Committee on Chemicals Scheduling (ACCS #26).

Submissions must be received by close of business 26 September 2019. See How to respond.

1. Proposed amendments referred for scheduling advice to ACMS #28

1.1. Paracetamol

CAS Number

103-90-2

Alternative names

Chemical/IUPAC Name: Acetamide, N-(4-hydroxyphenyl)ethanamide or N-(4-hydroxyphenyl) acetamide

INCI Name: Acetaminophen

Applicant

Delegate of the Secretary of the Commonwealth Department of Health

Current scheduling

Paracetamol is currently listed in Schedules 2, 3 and 4 and Appendix F and H of the Poisons Standard.

Proposed scheduling

It has been proposed to amend the Schedule 4 and Schedule 2 entries for paracetamol in the Poisons Standard as follows:

Schedule 4 - Amend Entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 30 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in Schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection;
  9. in liquid preparations for oral use except when in Schedule 2.

Schedule 2 - Amend Entry

PARACETAMOL for therapeutic use:

  1. liquid preparations for oral use containing no greater than 50 mg per mL of paracetamol in 100 mL with a maximum of 50 g paracetamol per container;
  2. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
  3. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
  4. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
  6. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  7. in other preparations except:
    1. when included in Schedule 3 or 4; or
    2. in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
      2. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      3. not labelled for the treatment of children 6 years of age or less, and
      4. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. packed in blister or strip packaging or in a container with a child-resistant closure,
      2. in a primary pack containing not more than 20 tablets or capsules,
      3. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      4. not labelled for the treatment of children 6 years of age or less, and
      5. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

Key uses/expected use

Human therapeutic use (analgesic and antipyretic)

Reasons for proposal

  • The paracetamol entries in Schedules 2, 3 and 4 of the Poisons Standard aim to minimise the risk of accidental poisoning by limiting the total dose in a pack. However, there is no limit on the amount of paracetamol that can be supplied in the liquid form in Schedule 2.
  • A product containing large quantities of paracetamol, particularly in liquid form, carries a potential for significant human toxicity (including delayed irreversible hepatotoxicity) if the product is accidently ingested or deliberately misused.
  • In view of the known risks of paracetamol toxicity to humans (the acute toxic effects include hepatic and renal tubular necrosis) and in the interests of public health, it is appropriate to limit the volume or maximum paracetamol mass in Schedule  2 paracetamol liquid preparations.
  • Liquid paracetamol products are marketed in formulations containing:
    • 24 mg/mL paracetamol in 50, 100, 200 and 500 mL pack sizes;
    • 48 mg/mL paracetamol in 50, 100, 200 and 500 mL pack sizes;
    • 50 mg/mL paracetamol in 60, 100, 200 and 1000 mL pack sizes;
    • 100 mg/mL paracetamol in 5 and 20 mL pack sizes; and
    • 32.5 mg/mL paracetamol + 1 mg/mL dextromethorphan in 120, 240 and 360 mL pack sizes (intended primarily for use in children, are currently available as a Pharmacy Medicine (Schedule 2)).

International restrictions

Paracetamol is on the World Health Organisation's List of Essential Medicines,[1] which lists the most effective and safe medicines needed in a health system.



1.2. Hyoscine butylbromide

CAS Number

149-64-4

Alternative names

N-butylhyoscinium bromide; Scopolamine-N-butylbromide; N-Butyl scopolammonium bromide; and scopolamine butylbromide

Applicant

Private Applicant

Current scheduling

Hyoscine butylbromide is currently listed in Schedule 2 of the Poisons Standard as follows:

Schedule 2

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.

Index

HYOSCINE BUTYLBROMIDE

Schedule 2

HYOSCINE
cross reference: HYOSCINE BUTYLBROMIDE

Proposed scheduling

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

Schedule 2 - Amend Entry

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance:

  1. in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide; or
  2. in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide.

Key uses/expected use

Medicine indicated for the treatment of spasms of the gastrointestinal tract, biliary spasm and renal spasm and as a diagnostic aid in radiology.

Reasons for proposal

  • The oral tablet dose form of this medicine containing either 10 mg or 20 mg of hyoscine butylbromide per tablet in preparations containing 200 mg or less is currently scheduled as a Schedule 2 (Pharmacy Only) medicine in Australia. This application seeks to amend the Poisons Standard to classify the (undivided) oral liquid dose form for preparations containing 20 mg or less per dose unit in a pack containing 200 mg or less hyoscine butylbromide from a 'Prescription Only' (Schedule 4) to a 'Pharmacy Only' (Schedule 2) medicine. This will result in the harmonisation of the scheduling of the oral tablet and liquid dose forms when supplied in packs containing equivalent amounts of hyoscine butylbromide per dose unit and in the entire pack.
  • Abdominal cramping and pain is not life-threatening, but it has a significant impact on the patient's quality of life and subsequent socioeconomic consequences.[2] Abdominal pain is one of most common reasons for people seeking medical care and hyoscine butylbromide has been proven to be safe and effective when used for relief from pain and discomfort of stomach cramps and spasm. The down-scheduling of the oral liquid dose will provide a significant benefit for paediatric and elderly patients, or other patient groups with dysphagia and difficulty swallowing the tablets (the currently available oral dose form, and classified under Schedule 2).
  • The rescheduling of the oral liquid dose form of hyoscine butylbromide at the suggested strength in the respective pack size will not impose any safety risks to the Australian population as the total amount of active pharmaceutical ingredient being sold per pack is the same as in the oral tablet packs; and, control over the medicine is maintained as the pharmacist can refer the individual to their doctor to establish clinical need if they present symptoms that are potentially due to another underlying disorder or illness.

International restrictions

  • Hyoscine butylbromide is currently registered as an over-the-counter (OTC) product in Belgium, Germany, Italy, Luxembourg, the Netherlands, Spain, Switzerland, the United Kingdom (UK), Argentina, Colombia, Mexico, Venezuela, Japan and South Korea.
  • Hyoscine buytlbromide is on the World Health Organisation's (WHO) List of Essential Medicines, the most effective and safe medicines needed in a health care system.
  • The European Chemicals Agency (ECHA) hazard classification and labelling for hyoscine butylbromide is as follows: 'Danger...this substance is harmful if swallowed, is harmful if inhaled and causes serious eye damage.'

Footnotes


1.3. Calcifediol monohydrate

CAS Number

63283-36-3

Alternative names

IUPAC: (3β,5Z,7E)-9,10-secocholesta-5,7-10(19)-triene-3,25-diol monohydrate

ANN: Calcifediol monohydrate

Applicant

The Therapeutic Goods Administration

Current scheduling

Calcifediol monohydrate is not specifically scheduled in the current Poisons Standard. However, it is considered a derivative of vitamin D and is therefore covered by the existing schedule entries for vitamin D.

Vitamin D is currently listed in Schedules 3 and 4 and Appendix H of the Poisons Standard as follows:

Schedule 4

VITAMIN D for human internal therapeutic use except:

  1. in preparations containing 25 micrograms or less of vitamin D per recommended daily dose; or
  2. when included in Schedule 3.

Schedule 3

VITAMIN D for human internal therapeutic use in preparations containing 175 micrograms or less of vitamin D per recommended single weekly dose except in preparations containing 25 micrograms or less of vitamin D per recommended daily dose.

Appendix H

VITAMIN D

Index

VITAMIN D
cross reference: COLECALCIFEROL, ERGOCALCIFEROL

Schedule 4
Schedule 3
Appendix H

Proposed scheduling

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

Schedule 4 - New Entry

CALCIFEDIOL MONOHYDRATE for human internal therapeutic use except in preparations containing 10 micrograms or less of calcifediol monohydrate per recommended daily dose.

Index - New Entry

CALCIFEDIOL MONOHYDRATE

Schedule 4

Key uses/expected use

Source of vitamin D in human dietary supplements.

Reasons for proposal

  • Vitamin D (in both the colecalciferol and ergocalciferol forms) has a well-established profile and history of use. Calcifediol is the immediate metabolite of colecalciferol and is the circulating form of Vitamin D in the human body.
  • The TGA has identified that calcifediol provides the same health benefits as colecalciferol, however the potency appears to be approximately three times greater. The safe daily dosage recommended by the TGA after evaluation is <10 micrograms/day in comparison to the Vitamin D scheduling limit of <25 micrograms/day.
  • Calcifediol, as a direct metabolite of colecalciferol, would fall within the current scheduling entry for Vitamin D; i.e. it would be unscheduled at a daily dose of less than 25 micrograms per day. However, a safety evaluation performed by the TGA showed that the safe dosage for calcifediol is less than 10 micrograms per day. As such, it is proposed that a separate schedule entry be created for calcifediol to restrict the daily dosage to less than 10 micrograms per day unless medically prescribed.

1.4. Lidocaine

CAS Number

137-58-6

Alternative names

2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide (IUPAC), lignocaine, xylocaine

Applicant

Private Applicant

Current scheduling

Lidocaine is currently listed in Schedules 2, 4 and 5 of the Poisons Standard as follows:

Schedule 5

LIDOCAINE in aqueous gel preparations containing 4.5 per cent or less of lidocaine, for the dermal spray-on administration to post-surgical wounds associated with 'mulesing' of sheep; tail docking and castration of lambs; or castration and disbudding/dehorning in calves.

Schedule 4

LIDOCAINE except:

  1. when included in Schedules 2 or 5;
  2. in dermal preparations containing 2 per cent or less of total local anaesthetic substances per dosage unit; or
  3. in lozenges containing 30 mg or less of total anaesthetic substances per dosage unit.

Schedule 2

LIDOCAINE in preparations for topical use other than eye drops:

  1. containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
  2. in divided preparations containing 200 mg or less of total local anaesthetic substances, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

LIDOCAINE

Schedule 5
Schedule 4
Schedule 2

Proposed scheduling

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

Schedule 2 - Amend Entry

LIDOCAINE in preparations for topical use other than eye drops:

  1. containing 10 per cent or less of total local anaesthetic substances, except:
    1. in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
    2. in aqueous sprays for oromucosal use containing 0.6 per cent or less of total local anaesthetic substances; or
  2. in divided preparations containing 200 mg or less of total local anaesthetic substances, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

Key uses/expected use

Medicines

Reasons for proposal

  • Lidocaine 0.6% throat sprays can appropriately be classified as 'exempted from scheduling' as set out in the Scheduling Handbook.
  • Lidocaine 0.6% throat sprays can be supplied with reasonable safety and without any access to health professional advice on the same basis that lidocaine throat lozenges are currently available at higher doses without access to health professional advice.
  • The proposed amendment meets and exceeds all of the factors for Schedule 2.
  • There are legitimate reasons for people to prefer the use of a low-dose spray in preference to a lozenge in relieving the pain of a sore throat.
  • Changing the classification of lidocaine 0.6% throat sprays to unscheduled will allow people to choose between those dose forms without having to visit a pharmacy.

1.5. Paracetamol and ibuprofen

CAS Number:

Paracetamol: 103-90-2

Ibuprofen: 15687-27-1

Alternative names

Paracetamol: N-(4-hydroxyphenyl)acetamide (IUPAC); 4′-Hydroxyacetanilide; 4-Acetamidophenol, N-Acetyl-4-aminophenol; N-acetyl-p-aminophenol (APAP); Acetaminophen

Ibuprofen: (RS)-2-(4-(2-Methylpropyl)phenyl)propanoic acid (IUPAC); α-Methyl-4-(isobutyl)phenylacetic acid, (±)-2-(4-Isobutylphenyl)propanoic acid; isobutylphenylpropionic acid

Applicant

Private Applicant

Current scheduling

Paracetamol is currently listed in Schedules 2, 3 and 4 and Appendix F and H of the Poisons Standard.

Ibuprofen is currently listed in Schedules 2, 3 and 4 and Appendix F and H of the Poisons Standard.

Proposed scheduling

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

Schedule 4 - Amend Entry

PARACETAMOL:

  1. when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
  2. when combined with ibuprofen in a primary pack containing more than 3050 dosage units;
  3. in slow release tablets or capsules containing more than 665 mg paracetamol;
  4. in non-slow release tablets or capsules containing more than 500 mg paracetamol;
  5. in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
  6. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
  7. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
  8. for injection.

Schedule 3 - Amend Entry

PARACETAMOL when combined with ibuprofen in a primary pack containing 3050 dosage units or less except when included in or expressly excluded from Schedule 2.

Schedule 2 - Amend Entry

PARACETAMOL for therapeutic use:

  1. when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 1230 dosage units per pack except in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
  2. in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
  3. in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  4. in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
  5. in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
  6. in other preparations except:
    1. when included in Schedule 3 or 4; or
    2. in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
      2. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      3. not labelled for the treatment of children 6 years of age or less, and
      4. not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaifenesin; or
    3. in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:
      1. packed in blister or strip packaging or in a container with a child-resistant closure,
      2. in a primary pack containing not more than 20 tablets or capsules,
      3. compliant with the requirements of the Required Advisory Statements for Medicine Labels,
      4. not labelled for the treatment of children 6 years of age or less, and
      5. not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

Appendix F, Part 3

PARACETAMOL

Warning Statements: 97 (Adults: Keep to the recommended dose. Don't take this medicine for longer than a few days at a time unless advised to by a doctor); AND/OR 98 (Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor); 99 (If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26; New Zealand 0800 764 766) or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage); 100 (Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist).

Appendix H

PARACETAMOL.

Index

PARACETAMOL
cross reference: ASPIRIN, IBUPROFEN, METOCLOPRAMIDE, SALICYLAMIDE, CAFFEINE

Schedule 4
Schedule 3
Schedule 2
Appendix F, Part 3
Appendix H

Key uses/expected use

Medicines

Reasons for proposal

  • This application proposes a logical sequence of controls on paracetamol/ibuprofen combinations based on pack size with 12 dosage units or less as 'exempted from scheduling', 13 to 30 dosage units or less as 'Pharmacy Medicine' (Schedule 2), 31 to 50 dosage units or less as 'Pharmacist Only Medicine' (Schedule 3) and larger pack sizes as 'Prescription Only Medicine' (Schedule 4).
  • Paracetamol and ibuprofen used separately have long been recognised as safe and effective for the treatment of simple self-limiting pain. The risks that do exist are addressed by label warning statements with small packs being available for general sale and larger packs being available in Schedules 2 or 3.
  • The proposed pack sizes for the combination in terms of days' treatment per pack are broadly consistent with pack sizes currently available without prescription for paracetamol or ibuprofen used separately. Quantities of up to 17 days' supply may legitimately be required for short term treatment of intermittent pain over a period of time or where more than one person in a household uses the same medicine. This is currently the case for ibuprofen in Schedule 2 and is now being proposed for the combination in Schedule 3 where pharmacist advice represents a further level of safety.
  • The two 'originator' products approved by TGA (XXXX and XXXX) have now been available in Australia since 2013/2014 and in New Zealand since 2011. During that time there have been no 'serious' adverse events reported to TGA or to Medsafe and the number of adverse reactions relative to sales has been small.
  • In New Zealand XXXX and XXXX have been available since 2011 as 'general sales' items in packs of 20 and as 'pharmacy medicine' items in packs of 100. In addition, the maximum daily dose of XXXX in Australia is less than half the maximum daily dose of XXXX and exactly half the maximum daily dose of XXXX in New Zealand.
  • It has been accepted that the risk of consumers confusing their temporary pain condition with more serious diseases or conditions is very small.
  • In recognition of the differences in approved dose between the two major brands of paracetamol/ ibuprofen (XXXX and XXXX) and between these products and paracetamol and ibuprofen used separately XXXX proposes to draw attention to the '1 tablet dose' of XXXX on the front of pack.
  • Combinations of paracetamol and ibuprofen are able to be supplied in pack sizes of up to 12 dosage units, with reasonable safety, without access to health professional advice and this small pack size falls outside the factors for Schedules 2, 3, 4 or 8 in the same way that small packs of paracetamol or ibuprofen used separately fall outside these factors.
  • Ongoing long-term treatment with any analgesic requires medical intervention. The proposed Schedule 4 pack of more than 50 dosage units will achieve this while enabling medical practitioners to prescribe larger quantities when appropriate.

2.Proposed amendments referred for scheduling advice to ACCS #26

2.1. Carbon monoxide

CAS Number

630-08-0

Alternative names

Carbon monooxide, carbonous oxide, carbon (II) oxide, carbonyl, flue gas, monoxide

Applicant

Delegate of the Secretary of the Commonwealth Department of Health

Current scheduling

Carbon monoxide is not specifically scheduled in the current Poisons Standard.

Proposed scheduling

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

Schedule 7 - New Entry

CARBON MONOXIDE except when included in Schedule 6.

Schedule 6 - New Entry

CARBON MONOXIDE in pressurised gas canisters or cylinders

Appendix E - New entry

CARBON MONOXIDE

Appendix F - New entry

CARBON MONOXIDE

Part 1 - Warning Statements

Part 2 - Safety Directions - General

Appendix J, Part 2 - New Entry

CARBON MONOXIDE

Index - New Entry

CARBON MONOXIDE

Schedule 7
Schedule 6
Appendix E
Appendix F
Appendix J, Part 2

Key uses/expected use

Industrial use.

Reasons for proposal

To mitigate public health risks of deliberate inhalation.

2.2 Momfluorothrin

CAS Number

609346-29-4

Alternative names

CAS Name: 2,3,5,6-tetrafluoro-4-(methoxymethyl)phenyl)methyl 3-(2-cyano-1-propen-1-yl)-2,2-dimethylcyclopropanecarboxylate

IUPAC Name: 2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1RS,3SR)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate

Applicant

The Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Momfluorothrin is currently listed in Schedule 6 of the Poisons Standard as follows:

Schedule 6

MOMFLUOROTHRIN.

Index

MOMFLUOROTHRIN

Schedule 6

Proposed scheduling

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

Schedule 6 - Amend Entry

MOMFLUOROTHRIN except in preparations containing 0.2 per cent or less of momfluorothrin.

Key uses/expected use

Insecticide for indoor and outdoor use

Reasons for proposal

  • The proposal is to amend the Schedule 6 entry for momfluorothrin to include a concentration cut-off for preparations containing 0.2 per cent or less of momfluorothrin. This proposal is consistent with the original consideration for scheduling, when momfluorothrin was included in Schedule 6 without a cut-off. The Scheduling delegate's final decision on momfluorothrin, published on the TGA website on 19 November 2015, noted that it may be possible to consider a lower schedule for products with a low percentage content of momfluorothrin at a later time.
  • The data provided with this application supports a lower schedule for products containing momfluorothrin at 0.2 per cent or less, through the evaluation of acute toxicity tests conducted using a product containing 0.17% momfluorothrin and 0.33% d-phenothrin. The acute oral toxicity tests on the product were conducted using modern protocols that were tested up to 2000 mg/kg bw, with no adverse clinical signs.
  • In acute toxicity studies in rats, momfluorothrin was of low acute oral toxicity, low acute dermal toxicity and low acute inhalation toxicity. Momfluorothrin was a slight eye irritant in rabbits, but was not a skin irritant in rabbits or a skin sensitiser in guinea pigs (maximization test).
  • The cut off of 0.2 per cent or less is considered to be supported by the data evaluated by the APVMA, based on the toxicity study results from formulations containing 0.17 per cent momfluorothrin in either a hydrocarbon or water based formulation.

2.3 Methiozolin

CAS Number

403640-27-7

Alternative names

IUPAC name: 5RS)-5-[(2,6-difluorobenzyloxy)methyl]-4,5-dihydro-5- methyl-3-(3-methyl-2-thienyl)-1,2-oxazole

Applicant

The Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Methiozolin has not been previously considered for scheduling.

Proposed scheduling

The Applicant's proposed amendments to the Poisons Standard are:

Schedule 5 - New Entry

METHIOZOLIN.

Index - New Entry

METHIOZOLIN

Key uses/expected use

Agricultural herbicide

Reasons for proposal

  • It is proposed that methiozolin be included in Schedule 5 of the Poisons Standard, based on sufficient toxicological data being available to recommend a scheduling decision.
  • The data supports that methiozolin has very low toxicity across the toxicological database and does not appear to present any substantial toxicological hazard. Methiozolin has very low acute toxicity by oral, dermal and inhalational routes.
  • Methiozolin is not a skin irritant or sensitiser but causes a slight eye irritation in rabbits. The active was not genotoxic in a battery of in vivo and in vitro assays. There were no adverse effects on reproduction or development observed. Methiozolin was not neurotoxic in an acute study.
  • The product, (containing 250 g/L of methiozolin), has low acute toxicity by the oral, dermal and inhalational routes, is moderately irritating for the skin and eye, but is not a skin sensitiser in guinea pigs by the Buehler method. There are no other concerns in relation to the potential health hazard when used according to the proposed draft label.
  • The management of methiozolin toxicological risks would be adequately achieved through a listing in Schedule 5 of the SUSMP with no cut-off or exemptions.

2.4 Lambda cyhalothrin

CAS Number

91465-08-6

Alternative names

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

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Lambda-cyhalothrin is currently listed in Schedules 5, 6 and 7 of 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

LAMBDA-CYHALOTHRIN:

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

Index

LAMBDA-CYHALOTHRIN

Schedule 7
Schedule 6
Schedule 5

Proposed scheduling

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

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 2.510 per cent or less of microencapsulated lambda-cyhalothrin.

Key uses/expected use

Insecticide

Reasons for proposal

Based on the product acute toxicity, and providing that adequate warnings and safety directions are displayed on the product label, the product formulation containing lambda-cyhalothrin meets the Scheduling Policy Framework (2018) criteria for Schedule 5 of the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). There are no other concerns in relation to the potential health hazard when used according to the proposed draft label. The product is presented in a similar manner to a range of other commonly available insecticidal sprays. No specialised equipment, apart from standard agricultural personal protective equipment (PPE), is required for safe use.

2.5 Tetraniliprole

CAS Number

1229654-66-3

Alternative names: 1H-pyrazole-5-carboxamide, 1-(3-chloro-2-pyridinyl)-N-[4-cyano-2-methyl-6-[(methylamino) carbonyl]phenyl]-3-[[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl]-; 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)- 2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide

Applicant

Australian Pesticides and Veterinary Medicines Authority (APVMA)

Current scheduling

Tetraniliprole has not previously been considered for scheduling.

Proposed scheduling

To exclude tretraniliprole from scheduling

Key uses/expected use

Insecticide

Reasons for proposal

The data supports that tetraniliprole has low toxicity across the toxicological database and does not appear to present any substantial toxicological hazard.

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 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 February 2020.

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Enquiries

Any questions relating to submissions should be directed by email to medicines.scheduling@health.gov.au or chemicals.scheduling@health.gov.au.