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Revised final decisions amending, or not amending, the current Poisons Standard to correct for minor administrative errors, September 2018

Scheduling medicines and poisons

28 September 2018

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4.3 Appendix J

Part B: Amendments to the Poisons Standard not referred to an expert advisory committee

4. Delegate-only decisions on agricultural and veterinary chemicals

4.3 Appendix J

Delegate's final decision

The delegate's final decision under regulation 42ZCZU of the Therapeutic Goods Regulations 1990 (the Regulations) is to amend Appendix J of the Poisons Standard as follows:

Appendix J - Schedule 7 Poisons requiring additional controls on availability and use

Part 1 - Authorisation considerations for availability and use

All poisons included in this Appendix are not to be available except to authorised or licensed persons.

The use of a poison may be restricted for a particular purpose. Controls recommended for the Schedule 7 poisons listed in the table below may be implemented through poisons controls or other State or Territory legislation.

Authorisation considerations
a Poisons marked with 'a' are restricted to analytical or research purposes only.
p Poisons marked with 'p' have been identified as representing a significant risk to public health. Additional restrictions on their possession and use must be applied through an authorisation or licensing process which includes a case by case assessment of risks to public health.

PART 2

A poison listed in this Appendix is to be available in accordance with the authorisations considerations specified beside it in the "Authorisation Considerations" column.

Note

New text is shown as green, larger font, with a horizontal line above it.

Deleted text is shown as red, smaller font, with a strikethrough.

Poisons Authorisation considerations
ABAMECTIN  
ACIBENZOLAR-S-METHYL  
ACROLEIN  
ACRYLONITRILE  
ALACHLOR a
ALLYL ALCOHOL  
4-AMINOPROPIOPHENONE ap
4-AMINOPYRIDINE  
ARPRINOCID a
ARSENIC p
AZOCYCLOTIN a
BENZENE  
BIFLUORIDE  
BORON TRIFLUORIDE  
BRODIFACOUM  
BROMADIOLONE  
BROMINE  
BRUCINE  
CALCIFEROL  
CAPTAFOL a
CARBADOX  
CARBON TETRACHLORIDE
CARBONYL SULFIDE  
CHLORDECONE a
CHLORDIMEFORM a
CHLORINE  
CHLOROMETHIURON a
CHLOROPICRIN  
4-CHLORO-o-TOLUIDINE a
COLECALCIFEROL  
COUMATETRALYL  
CYANOGEN  
CYHEXATIN a
4,4-DIAMINODIPHENYLMETHANE  
1,2-DIBROMO-3-CHLOROPROPANE a
1,3-DICHLOROPROPENE  
DIFENACOUM  
4-DIMETHYLAMINOAZOBENZENE a
DINITROCRESOLS a
DINITROPHENOLS a
DINOSEB a
EPICHLOROHYDRIN  
EPIDERMAL GROWTH FACTOR  
ETACONAZOLE a
ETHYLENE DIBROMIDE a
ETHYLENE OXIDE  
FLUOROACETAMIDE p
FLUOROACETIC ACID p
FOLPET  
HALOFUGINONE  
HALOGENATED DIBENZODIOXINS AND DIBENZOFURANS a
HCB a
HYDROCYANIC ACID AND CYANIDES p
HYDROFLUORIC ACID  
HYDROSILICOFLUORIC ACID  
IODOMETHANE  
MADURAMICIN  
MERCURY  
METHACRIFOS  
METHOXYETHYLMERCURIC ACETATE a
METHOXYETHYLMERCURIC CHLORIDE  
METHYL BROMIDE  
4,4'-METHYLENEBIS[2-CHLOROANILINE]  
MIREX a
MOLINATE  
NICOTINE  
NITROFEN a
PHENYLMERCURIC ACETATE  
PHOSPHIDE, metallic  
PHOSPHINE  
PROPYLENE OXIDE  
PYRINURON a
STRYCHNINE p
SULCOFURON a
TETRACHLOROETHANE  
2,2',6,6'-TETRAISOPROPYL-DIPHENYL-CARBODIIMIDE  
THALLIUM p
o-TOLIDINE  
VINYL CHLORIDE  

I have also decided that the following three factors are added to Appendix J criteria in the Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018):

  1. Significant, or potential to cause, severe and possible irreversible injury may occur without the individual being aware of exposure - whether that is a single or repeated exposure or a low or high dose exposure.
  2. Specialised skills and/or equipment are required to mitigate the risks of using the poison.
  3. The patterns of use of the poison pose an unacceptable risk resulting from direct or indirect exposure to the public.
Implementation date: 1 October 2018
Reasons:
  • Appendix J poisons be available only to authorised or licensed persons.
  • The use of Appendix J poisons that are banned, obsolete or subject to international conventions should be restricted to analytical and research purposes only.
  • States and Territories use Appendix J to inform regulatory controls and practices.
  • The use patterns for 27 of the 80 Appendix J poisons have changed over time due to factors such as:
    • Being subject to international conventions to which Australia is a party
    • Being banned based on evidence of harm to people and/or the environment
    • No longer registered for pesticide and veterinary uses with the Australian Pesticides and Veterinary Medicines Authority (APVMA). These poisons were not identified as having a use beyond analytical or research purposes. The use of a poison in this context does not pose a significant public health risk although some of them are still permitted for use or are being manufactured in other countries. Therefore the possibility of unlawful supply and possession of these poisons and potential public health risk in Australia remains.
  • Regulatory agencies will benefit from additional guidance on poisons subject to national or international restrictions to ensure appropriate controls are applied.
  • Previous Appendix J included four conditions (1-4), although only two of the conditions were applied (1 and 3).
    • Condition 1 (Not to be available except to authorised or licensed persons) applies to 76 of the 80 poisons;
    • Condition 3 (Not to be used except by or in accordance with the directions of accredited government vermin control officers.) applies only to 4 -aminopropiophenone, fluoroacetic acid, fluoroacetamide and thallium.
  • Condition 3 is outdated with respect to current vertebrate pest management practices and terminology. The intent of the control to limit the use of the specified Appendix J poisons is supported by State and Territory vertebrate pest management frameworks that identify persons accessing and using these poisons.
  • Trichloroisocyanuric Acid - no longer has an S7 listing and thus does not meet the current inclusion requirements for Appendix J

Cyanide, strychnine, thallium, fluoroacetic acid, fluoroacetamide, hydrocyanic acid and arsenic - these poisons were previously listed in Part 3 paragraph 41 of the SUSMP as poisons representing such a risk to public health that persons seeking to possess and use them had to hold specific authorisation from an appropriate authority. An inadvertent omission in 2015 removed the additional control over possession from the current version of the SUSMP. The controls need to be reinstated to ensure the continued management of public health risk.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate for the decision include:

  • The outcomes report of the Appendix J review conducted by the Interjurisdictional Working Group Poisons Control (IJWPC) which includes consultation responses;
  • The letter to the Secretary of the Department of Health from the chair of the IJWPC dated 18 April 2018;
  • An email from the IJWPC dated 27 July 2018 confirming Appendix J amendments;
  • Appendix J consultation paper dated May 2017;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • Section 52E of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.
Applicant's scheduling proposal and reasons for proposal

The review of Appendix J completes the actions that were agreed to by the Australian Health Ministers Advisory Council (AHMAC) to achieve national consistency of controls on poisons in response to the 2008 Productivity Commission Research Report on Chemicals and Plastics Regulation.

Background information for Appendix J
Appendix J Review:
  • Review of Appendix J is the final deliverable - AHMAC 2013 Implementation Plan for Productivity Commission's Chemical Regulation Reforms.
  • DECISION RIS The NCCTG Strategies to implement a national approach to poisonous chemical controls:
    • Undertake assessment of risk posed by the chemicals.
    • Update the poisons currently in Appendix J that are subject to additional controls to reflect contemporary use patterns.
  • Qld agreed to lead with support from interjurisdictional working group formed under AHMAC.
  • Review commenced in 2015.
Appendix J - current status
  • Appendix J currently contains eighty (80) S7 poisons identified as requiring additional controls on their availability and use.
  • These poisons have uses in industrial, manufacturing, agricultural, veterinary, research and analytical purposes.
  • There are variations in the way jurisdictions have implemented controls over Appendix J poisons.
  • Controls are administered by agriculture, health and/or workplace health and safety portfolios.
  • Some jurisdictions also have expanded the scope beyond Appendix J.
Review process
  • Examine the availability, contemporary use patterns and potential for public exposure of Appendix J poisons.
  • Review toxicity - updated profiles, studies etc. if available.
  • Examine non-Appendix J S7 poisons currently subject to jurisdictional controls of availability, possession, and use.
  • Examine adequacy of existing controls.
  • Develop criteria for inclusion of S7 poisons in Appendix J.
Review findings
  • Discontinued uses
    • applies to 27 of the 80 Appendix J poisons.
    • subject to international conventions, are banned or no longer registered by the APVMA.
  • Scheduling review
    • Trichloroisocyanuric acid - no longer an S7 poison.
    • 4-dimethylaminobenzene - could be included in the current broader review of the scheduling of azo dyes.
  • Errors
    • An inadvertent omission in 2015 resulted in removal of public health controls over certain poisons listed in Part 3 paragraph 41 of the SUSMP.
  • Review current controls
    • Appendix J includes four conditions, although only two of the conditions are applied as per table below:
    # Condition Condition status
    1. Not to be available except to authorised or licensed persons. In use
    2. Not to be used in printing inks. Not in use
    3. Not to be used except by or in accordance with the directions of accredited government vermin control officers. In use
    4. Not to be used in industries which handle, process or store foods, animal feeds or packaging materials. Not in use
  • Condition 1 applies to 76 of the 80 poisons
  • Condition 3 applies only to PAPP, fluoroacetic acid, fluoroacetamide and thallium
Changes to Appendix J Endorsed by AHMAC December 2017
  • All 78 poisons to be only accessed and used by authorized or licensed persons
  • Authorization may be under WHS, agricultural or health legislation
  • Two poisons to be referred for scheduling review
  • Outdated conditions to be removed
  • 27 poisons with discontinued use to be only used for analytical or research purposes
  • Controls for possession and use for 7 poisons in the former Part 3, 41(3) of SUSMP to be reinstated
  • Name to be changed to "Schedule 7 Poisons Requiring Additional Controls on Availability and Use"
  • Endorsed the scheduling factors for inclusion of a Schedule 7 poison in Appendix J
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • The applicants scheduling proposal to update Appendix J
  • The outcomes report of the Appendix J review conducted by the Interjurisdictional Working Group Poisons Control (IJWPC) which includes consultation responses;
  • The letter to the Secretary of the Department of Health from the chair of the IJWPC dated 18 April 2018;
  • An email from the IJWPC dated 27 July 2018 confirming Appendix J amendments;
  • Appendix J consultation paper dated May 2017;
  • The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • Section 52E of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

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