Consultation: Proposed Amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, March 2018

Mixture of eprinomectins B1a and B1b;

(2aE,4E,8E)-(5'S,6S,6′R,7S,11R,13S,15S,17aR,20R,20aR,20bS)-6′-[(S)-sec-butyl]-5′,6,6′,7,10,11,14,15,17a,20,20a,20b-dodecahydro-20,20b-dihydroxy-5′,6,8,19-tetramethyl-17-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 4-O-(4-acetamido-2,4,6-trideoxy-3-O-methyl-α-L-lyxo-hexopyranosyl)-2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranoside (major component);

(2aE,4E,8E)-(5′S,6S,6′R,7S,11R,13S,15S,17aR,20R,20aR,20bS)- 5′,6,6′,7,10,11,14,15,17a,20,20a,20b-dodecahydro-20,20b-dihydroxy-6′-isopropyl-5′,6,8,19-tetramethyl-17-oxospiro[11,15-methano-2H,13H,17H-furo[4,3,2-pq][2,6]benzodioxacyclooctadecin-13,2′-[2H]pyran]-7-yl 4-O-(4-acetamido-2,4,6-trideoxy-3-O-methyl-α-L-lyxo-hexopyranosyl)-2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranoside (minor component).

Schedule 5 - Amend Entry

EPRINOMECTIN in preparations for internal use containing 0.5 per cent or less of eprinomectin.

• Eprinomectin preparations are currently registered for use in Australia as a pour-on formulation for beef and dairy cattle.
• This application is for a long-acting injectable product for use in cattle.
• Advice from the APVMA is that there are no objections on human health grounds for the registration of an injectable product containing eprinomectin.

(6R,25S)-5-O-Demetyl-28-deoxy-25-[(E)-1,3-dimetyl-1-butenyl]-6,28-epoxy-23-oxomilbemycin B 23-(E)-(O-metyloxime) (WHO);

Milbemycin B, 5-O-demetyl-28-deoxy-25-(1,3-dimetyl-1-butenyl)-6,28-epoxy-23-(metoxyimino)-, [6R,23E,25S(E)]- (USAN)

Schedule 5 - Amend Entry

MOXIDECTIN:

1. in preparations for external use for the treatment of animals other than cats and dogs, containing 0.5 per cent or less of moxidectin;
2. in preparations for external use for the treatment of cats and dogs, containing 2.5 per cent or less of moxidectin packed in single dose tubes with a volume of 1 mL or less; or
3. for internal use for the treatment of animals:
   1. in divided preparations for dogs, containing 250 micrograms or less of moxidectin per dosage unit in a pack containing six or less dosage units; or
   2. in other preparations containing 2 per cent or less of moxidectin. or
4. in preparations for injection for the treatment of sheep and cattle, containing 10 per cent or less of moxidectin.

Schedule 4 - Amend Entry

MOXIDECTIN in preparations for injection containing 10 per cent or less of moxidectin except when included in Schedule 5 for the treatment of dogs containing 10 per cent or less of moxidectin.

(2RS)-2-[4-(4-chlorophenoxy)-2- (trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl) propan-2-ol (IUPAC);

alpha-[4-(4-chlorophenoxy)-2-(trifluoromethyl) phenyl]- alpha-methyl-1H-1,2,4-triazole-1-ethanol (CAS).

• The available toxicological data for mefentrifluconazole is considered to be sufficient for the purposes of recommending a scheduling decision.
• Advice from the APVMA is that there are no objections on human health grounds for the approval of the active constituent.

Ethenyl acetate (IUPAC);

Vinyl acetate (INCI);

Acetic acid ethenyl ester (CAS);

Vinyl acetate monomer (VAM).

Not currently scheduled.

To be included in the Poisons Standard from 1 October 2018, as follows:

Schedule 6

VINYL ACETATE MONOMER (excluding its derivatives) except:

1. in preparations for therapeutic use; or
2. in preparations for domestic use containing 1 per cent or less of vinyl acetate; or
3. in preparations containing 0.01 per cent or less of vinyl acetate as residual monomer in a polymer.

Appendix E, Part 2

VINYL ACETATE

Standard Statements: A (For advice, contact a Poisons Information Centre or a doctor); R1 (If inhaled, removed from contaminated area. Apply artificial respiration if not breathing).

Appendix F, Part 3

VINYL ACETATE

Warning Statement: 11 (Vapour may be harmful).

Safety Directions: 8 (Avoid breathing vapour); 9 (Use only in well ventilated area).

Schedule 6 - Amend Entry

VINYL ACETATE MONOMER (excluding its derivatives) except:

1. in preparations for therapeutic use; or
2. in preparations for domestic use containing 1 per cent or less of vinyl acetate; or
3. in preparations containing 0.01 per cent or less of vinyl acetate as residual monomer in a polymer used in direct contact with the body, such as cosmetic preparations.

• To ensure that the scheduling of preparations not intended for skin contact that contain residual monomer vinyl acetate in a polymer are exempt from scheduling.
• Preparations containing over the cut-off level of point (b) of more than 1 per cent would still be captured by the Schedule 6 listing.

PROSTAGLANDINS:

• Carboprost
• Cloprostenol
• # Dinoprost
• # Dinoprostone
• Etiproston
• Fenprostalene
• Fluprostenol
• Gemeprost
• Misoprostol
• Prostianol

Due to inconsistencies with the inclusion of prostaglandins that have obstetric/gynaecological indications in Appendix D Item 1, it is proposed to standardise the scheduling of all applicable prostaglandins with obstetric/gynaecological indications with one of the following options:

• place all applicable prostaglandins in Appendix D Item 1 and include a general entry in Appendix D Item 1 for PROSTAGLANDINS "when used in obstetrics/gynaecology".
• OR
• remove those prostaglandins currently listed in Appendix D Item 1;

Due to queries at both Commonwealth and state/territory level on the meaning of the cannabidiol entry and how it affects products it is proposed to amend the following entries for cannabidiol, cannabis and tetrahydrocannabinols to ensure that the cannabidiol entry is clearly understood: