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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, May 2013

23 May 2013

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Interim decisions on proposal referred to an advisory committee: ACCS March 2013

1. March 2013 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) - ACCS # 7

1.1 Abamectin

Scheduling proposal

The Chemicals Scheduling Delegate considered a proposal to amend abamectin Schedule 6(a) entry to raise the cut-off from 2 to 4 per cent or less of abamectin in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Chemicals Scheduling (ACCS) for advice.

Scheduling history

In November 1984, the Poisons Schedule (Standing) Committee (PSC) considered scheduling of a 1 per cent avermectin B1 (a synonym for abamectin) injection to be used as an antiparasitic agent in animals. Based on toxicity, PSC decided to include this substance in Schedule 7. However, the PSC also noted the intent to only market a sealed container product for use with automated injection equipment and agreed to a Schedule 6 cut-off for such preparations when included in 10 mL or less injections.

In May 1992, the Drugs and Poisons Schedule Standing Committee agreed to a request to change the name of avermectin B1 in the schedule entries to abamectin, noting that this was the name approved by the Standards Association of Australia (now called Standards Australia).

In August 1994, the National Drugs and Poisons Schedule Committee (NDPSC) decided to include emulsifiable concentrate formulations containing abamectin at 18 g/L or less in Schedule 6.

In August 1995, NDPSC agreed to include ≤ 1 per cent abamectin for animal internal use in Schedule 5.

In June 2008, the NDPSC decided also to include slow-release plastic matrix ear tags for livestock use containing 1 g or less of abamectin in Schedule 6.

In October 2009, the NDPSC considered whether preparations for pesticidal use containing 0.0015 per cent or less of abamectin were consistent with the Schedule 5 criteria. It was agreed that although low concentration of abamectin were likely to be less hazardous, because insufficient data had been provided to allay the concern regarding the high acute oral, dermal and inhalation toxicity of abamectin, it was decided that the existing scheduling was appropriate, i.e. no changes.

Scheduling status

Abamectin is currently listed in Schedules 5, 6 and 7 and Appendix J.

Public pre-meeting submissions

No public submissions were received.

ACCS advice to the delegate

The ACCS recommended that the Schedule 6 cut-off for abamectin for pesticidal use be increased from 2 per cent to 4 per cent or less of abamectin.

The ACCS recommended an implementation date of 1 September 2013.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (b) the purpose for which a substance is to be used and the extent of use of a substance, (d) the dosage, formulation, labelling, packaging and presentation of a substance and (f) any other matters.

The reasons for the recommendation comprised the following:

  • the product was efficient against certain mites and insect pests of food crops.
  • the risk of health effects associated with potential exposures have been adequately addressed.
  • the MOE values were sufficient and a 1000-fold safety factor was considered to be protective of all toxicological findings.
Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not publically available);
  • scheduling application;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors1 ; and
  • other relevant information.
Delegate's interim decision

The delegate decided to accept the ACCS advice and to increase the Schedule cut-off to 4 per cent.

The proposed implementation date for this decision is 1 September 2013.

The relevant matters considered by the delegate under section 52E (1) of the Therapeutic Goods Act 1989 includes (c) the toxicity.

The decision to increase the Schedule 6 cut-off from 2 per cent to 4 per cent or less for abamectin for pesticidal use incorporated the following reasons:

  • the toxicity of abamectin is well characterised and increasing the Schedule 6 cut-off from 2 per cent to 4 per cent retains an adequate margin of exposure for workers using this product.
Schedule entry
Schedule 6 - Amendment

ABAMECTIN - Amend entry to read:

ABAMECTIN:

  1. in preparations for pesticidal use containing 4 per cent or less of abamectin except when included in Schedule 5; or
  2. in slow-release plastic matrix ear tags for livestock use containing 1 g or less of abamectin.

1.2 Carbonyl sulfide

Scheduling proposal

The Chemicals Scheduling Delegate considered a proposal to create new Schedule 7 and Appendix J entries for carbonyl sulfide in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Chemicals Scheduling (ACCS) for advice.

Scheduling history

Carbonyl sulfide (COS) has not been considered previously.

Scheduling status

COS is not listed in the SUSMP.

Public pre-meeting submissions

No public submissions were received.

ACCS advice to the delegate

The ACCS recommended that carbonyl sulfide when packed and labelled for use as a fumigant be included in Schedule 7.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (b) the purpose for which a substance is to be used and the extent of use of a substance, (c) toxicity and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The following reasons were noted:

  • COS was efficient against stored grain pests and imported biological products. It would be an efficient substitute for other toxic fumigants.
  • There was a risk of acute toxicity for applicators and bystanders.
  • COS has a steep acute dose response curve and neurotoxicity.
  • Toxicological database was limited.
  • The toxicity profile of COS satisfies the criteria for Schedule 7.
  • As a fumigant, it will require specialist training and equipment for use.
Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not publically available);
  • scheduling application;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors2 ; and
  • other relevant information.
Delegate's interim decision

The delegate accepts the recommendation of the ACCS that carbonyl sulfide be listed in Schedule 7 and Appendix J.

The proposed implementation date for this decision is 1 September 2013.

The relevant matters considered by the delegate under section 52E (1) of the Therapeutic Goods Act 1989 includes (a) the risks and benefits (b) the purpose, (c) the toxicity and (d) the dosage, formulation, labelling, packaging and presentation.

The decision to include carbonyl sulfide in Schedule 7 and Appendix J incorporated the following reasons:

  • COS has the potential to cause neurotoxicity and must be carefully handled. However, the availability of an alternate fumigant to possibly replace other more toxic fumigants is a potential benefit.
  • The acute toxicity of COS appears to fit with Schedule 6 criteria, but the steepness of the dose-response curve, the potential for neurotoxicity with chronic exposure, and the gaps in the available toxicity data suggest that Schedule 7 would be more appropriate.
  • Workers using COS as a fumigant will need appropriate training and specialist equipment to mitigate exposure.
Schedule entry
Schedule 7 - new entry

CARBONYL SULFIDE when packed and labelled for use as a fumigant.

Appendix J Part 2 - new entry
Poison Condition
Carbonyl sulfide 1
  1. [Secretariat note: Condition 1. Not to be available except to authorised or licensed persons.]

1.3 Chlorfenapyr

Scheduling proposal

The Chemicals Scheduling Delegate considered a proposal to create a new Schedule 5 entry for preparations containing 0.5 per cent or less chlorfenapyr, with consequent amendments to the current Schedule 7 and Schedule 6 entries in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Chemicals Scheduling (ACCS) for advice.

Scheduling history

In February 1996, the NDPSC considered the scheduling of chlorfenapyr. The NDPSC noted that in the dog an approximate oral LD50 of 9 mg/kg was determined when a single dose of 10 mg/kg resulted in the rapid death of 2 females. In chronic rat and dog dietary studies high doses were also reported to cause mild non-regenerative anaemia, which was unrelated to blood loss. A NOEL of 2.6 mg/kg/day in a rat dietary study was based on reduced weight gain and neurological lesions in male rats receiving higher doses. A NOEL of 2.1 mg/kg/day was determined in a 12 month dog study based on elevated creatinine levels in dogs receiving higher doses. In a rat developmental study no significant abnormalities were seen at the highest dose of 225 mg/kg/day. Based on the toxicology profile of chlorfenapyr, the NDPSC decided to include it in Schedules 6 and 7.

Scheduling status

Preparations containing 36 per cent or less chlorfenapyr are listed in Schedules 6 and all other preparations are listed in Schedule 7.

ACCS advice to the delegate

The ACCS recommended that chlorfenapyr in preparations containing 0.5 per cent or less of chlorfenapyr be included in Schedule 5.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (b) the purpose for which a substance is to be used and the extent of use of a substance, (c) toxicity and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The following reasons were noted:

  • chlorfenapyr is efficient against domestic and commercial insect and arachnid pests.
  • risk arises from the mechanism of toxicity of the product and its LD50.
  • dosage and formulation fits the criteria for Schedule 5, i.e. available in a ready use pack and the risk is reduced by the packaging.
Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not publically available);
  • scheduling application;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors3 ; and
  • other relevant information.
Delegate's interim decision

The delegate accepts the advice of the ACCS and agrees that products containing 0.5 per cent or less meet criteria for listing in Schedule 5. Accordingly, the delegate proposes to create a new Schedule 5 entry for chlorfenapyr.

The proposed implementation date for this decision is 1 September 2013.

The relevant matters considered by the delegate under section 52E (1) of the Therapeutic Goods Act 1989 includes (c) the toxicity and (d) the dosage, formulation, labelling, packaging and presentation.

The decision to include 0.5 per cent or less chlorfenapyr in Schedule 5 incorporated the following reasons:

  • the toxicity of chlorfenapyr is well characterised and creating a new Schedule 5 entry for a product containing 0.5 per cent retains an adequate margin of exposure for workers using this product.
  • the product under consideration is to be formulated in a ready-use pack, which is expected to minimise exposure potential for workers using the product.
Schedule entry
Schedule 5 - new entry

CHLORFENAPYR in preparations containing 0.5 per cent or less of chlorfenapyr.

Schedule 6 - amendment

CHLORFENAPYR - Amend entry to read:

CHLORFENAPYR in preparations containing 36 per cent or less of chlorfenapyr except when included in Schedule 5.

Schedule 7 - amendment

CHLORFENAPYR - Amend entry to read:

CHLORFENAPYR except when included in Schedules 5 or 6.

1.4 Eubacterium sp

Scheduling proposal

The Chemicals Scheduling Delegate considered a proposal to create a new Schedule 5 entry for Eubacterium sp in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Chemicals Scheduling (ACCS) for advice.

Scheduling history

In February 2009, the NDPSC considered scheduling of Eubacterium sp. strain DSM 11798. The NDPSC noted that strain DSM 11798 had low acute dermal toxicity in rats, was not a skin or eye irritant in rabbits and was not a skin sensitiser in guinea pigs. The applicant also submitted a 90-day sub-chronic oral study in rats, but no acute oral study nor a scientific argument as to why one was not provided. The NDPSC noted that strain DSM 11798 showed no evidence of toxicity or adverse effects up to 4.52 x 105 CFU/kg bw/day, equivalent to 200 mg/kg bw/day, via repeated oral administration. The NOEL was therefore > 4.52 x 105 CFU/g or 200 mg/kg bw/day. The NDPSC noted that there were insufficient data provided on various toxicity studies and decided not to make a scheduling decision.

Scheduling status

Eubacterium sp. is not specifically scheduled.

Public pre-meeting submissions

No public submissions were received.

ACCS advice to the delegate

The ACCS decided that it is unable to make a scheduling recommendation on Eubacterium sp. or on strain DSM11798 on the basis of the insufficiency of the data provided.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (b) the purpose for which a substance is to be used and the extent of use of a substance, (c) the toxicity and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The reasons for the recommendation comprised the following:

  • reduction of adverse effects of feed mycotoxins in intensive animal production.
  • additive to feed of pigs and poultry to minimise the effects of feed mycotoxins. Potentially widespread use in animal industries.
  • insufficient data on the specific characteristics of the organism to species level and quality assurance for the strain purity.
  • in addition, requiring informed comment on substrate specificity.
  • insufficient data on potential human pathogenicity and/or infectivity of the organism by all potential exposure routes, including intramuscular and intraperitoneal and intredermal.
  • submitted data indicated low toxicity except for acute inhalation.
  • presentation as a coarse particle feed premix.
Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not publically available);
  • scheduling application;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors5; and
  • other relevant information.
Delegate's interim decision

The delegate has decided to make a new entry for Eubactrium sp. strain DSM11798 in Appendix B.

The proposed implementation date for this decision is 1 September 2013.

The relevant matters considered by the delegate under section 52E (1) of the Therapeutic Goods Act 1989 includes (a) the risks and benefits and (c) the toxicity.

The decision to include Eubactrium sp. strain DSM11798 in Appendix B incorporated the following reasons:

  • this bacterial product has low toxicity and mild irritancy potential. The mild irritancy potential could be linked with physical abrasivity of formulation ingredients rather than the bacteria itself.
  • the applicant had adequately determined the pathogenicity of the naturally-occurring bacterial strain, low pathogenicity could be inferred from the arguments presented (mainly around it being an obligate anaerobe). The lack of specific pathogenicity tests should not be a reason to further defer a scheduling decision.
  • overall toxicity profile was consistent with several other bacterial substances currently listed in Appendix B, and accordingly the delegate decided to accept the recommendation of the evaluation report to make a new entry in Appendix B for Eubactrium sp. strain DSM11798.
Schedule entry
Appendix B, PART 3 New entry
Substance Date of entry Reason for listing Area of use
Eubacterium sp. strain DSM11798 Sep 2013 a 2.4

Part 1
Reasons for entry

  • a Low Toxicity

Part 2
Area of use

  • 2. Veterinary
    • 2.4 Feed additive

1.5 Pyroxasulfone

Scheduling proposal

The Chemicals Scheduling Delegate considered a proposal to delete the current pyroxasulfone Schedule 7 entry and amend the current Schedule 6 entry to a simple entry with no exemptions in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Chemicals Scheduling (ACCS) for advice.

Scheduling history

In September 2011, the delegate decided to create new Schedules 6 and 7 entries for pyroxasulfone. This decision included a cut-off to Schedule 6 from Schedule 7 for water dispersible granule preparations when used as a pre-emergence herbicide.

The delegate made this decision following the recommendation from the ACCS. The ACCS noted that while there were minimal acute toxicity concerns, there were serious repeat dose concerns, noting effects on the cardiac muscle even in short term studies. In addition to the cardiac concerns, there were nerve tissue effects at quite low exposure levels, and developmental neurotoxicity in longer term study. The ACCS also noted that a high margin of exposure (MOE) had been determined by the evaluator. However, the ACCS felt that the severity of the endpoints was such that the ACCS could not ignore the possibility of exposure. The Committee generally agreed that Schedule 7 was appropriate for the pyroxasulfone parent entry.

The ACCS noted that the evaluator had asked for a cut-off to Schedule 6 for products containing 85 per cent or less pyroxasulfone for pre-emergence herbicidal use. The ACCS agreed that the percentage component was unnecessary, particularly as the toxicity difference between the high concentration cut-off and the 100 per cent substance was likely to be minimal.

The ACCS noted that the likely exposure to pyroxasulfone given the use pattern was dermal and via inhalation, and that repeat dermal exposure was the main concern. The ACCS noted that this concern was significant enough to not allow any cut-offs from a Schedule 7 parent entry. The ACCS contended, however, that this concern was sufficiently mitigated for water dispersible granule formulations, due to their lower absorption potential. The ACCS suggested that this presentation could be the basis for a cut-off to Schedule 6. The ACCS agreed, noting the high MOEs determined by the evaluator for the water dispersible formulations, its minimised exposure potential and the additional risk mitigation measures intended to be implemented by the regulator through labelling.

Scheduling status

Pyroxasulfone is listed in Schedules 6 and 7.

ACCS advice to the delegate

The ACCS recommended that pyroxasulfone be rescheduled from Schedule 7 to Schedule 6 with no cut-offs.

The ACCS recommended an implementation date of 1 September 2013.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (c) the toxicity of a substance, (d) the dosage, formulation, labelling, packaging and presentation of a substance and (f) any other matters that the Secretary considers necessary to protect public health.

The following reasons were noted:

  • new data allowing more informed judgement showing that findings, whilst still treatment-related, were not toxicologically significant.
  • pyroxasulfone is no longer considered to be a developmental neurotoxicant.
  • it would be unlikely that there would be any variation in toxicity between 100% and 85 per cent.
  • lack of data to determine a cut-off.
Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not publically available);
  • scheduling application;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors5; and
  • other relevant information.
Delegate's interim decision

The delegate has decided to accept the advice of the ACCS and the scheduling recommendation of the evaluation report, and consolidate the scheduling of pyroxasulfone in Schedule 6, with no cut-off.

The proposed implementation date for this decision is 1 September 2013.

The relevant matters considered by the delegate under section 52E (1) of the Therapeutic Goods Act 1989 includes (c) the toxicity and (d) the dosage, formulation, labelling, packaging and presentation.

The decision to include pyroxasulfone in Schedule 6, with no cut-off incorporated the following reasons:

  • the primary reason for including pyoxasulfone in Schedule 7 when originally scheduled was concern over its developmental neurotoxicity potential. This concern has been ameliorated by the presentation of new data and argument relating to the signal toxic event in rat studies. While the human relevance of the renal papillary tumours seen in male rats is still not completely resolved, the delegate agrees with the ACCS that this finding does not warrant retaining pyroxasulfone in Schedule 7.
  • the high concentration of pyoxasulfone in the product under consideration does not allow for differentiation of its toxicity from the technical grade active substance. Hence no cut-off to a lower schedule is proposed.
Schedule entry
Schedule 6 - Amendment

PYROXASULFONE - Amend entry to read:

PYROXASULFONE.

Schedule 7 - Amendment

PYROXASULFONE – Delete entry

1.6 Sulfoxaflor

Scheduling proposal

The Chemicals Scheduling Delegate considered a proposal to create a new Schedules 6 and/or 5 entries for sulfoxaflor in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Chemicals Scheduling (ACCS) for advice.

Scheduling history

Sulfoxaflor was not considered for scheduling previously.

Scheduling status

Sulfoxaflor is not specifically scheduled.

Neonicotinoid insecticides such as, clothianidin, imidacloprid, thiamethoxam are listed in Schedules 5 and 6, and nitenpyram, thiacloprid, and acetamiprid are listed in Schedule 6.

Public pre-meeting submissions

No public submissions were received.

ACCS advice to the delegate

The ACCS recommended that sulfoxaflor be included in Schedule 6 with a cut-off to Schedule 5 for preparations containing less than 25 per cent of sulfoxaflor.

The ACCS recommended an implementation date of 1 September 2013. The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (b) the purpose, (c) the toxicity of a substance and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The following reasons were noted:

  • efficient against damaging insect pests and many agricultural and horticultural crops.
  • toxic effects to applicator therefore require PPEs and label warning statements.
  • not for domestic use.
  • moderate toxicity of the active ingredient and lower toxicity of the preparation containing 24 per cent sulfoxaflor.
Delegate's consideration

The delegate considered the following in regards to this proposal:

  • the evaluation report (not publically available);
  • scheduling application;
  • ACCS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors6; and
  • other relevant information.
Delegate's interim decision

The delegate accepts the advice of the ACCS and agrees that sulfoxaflor meets criteria for listing in Schedule 6. The delegate also proposes to create a new Schedule 5 entry for products containing 25 per cent or less sulfoxaflor.

The proposed implementation date for this decision is 1 September 2013.

The relevant matters considered by the delegate under section 52E (1) of the Therapeutic Goods Act 1989 includes (c) the toxicity and (d) the dosage, formulation, labelling, packaging and presentation.

The decision to include sulfoxaflor in Schedules 5 and 6 incorporated the following reasons:

  • the acute and chronic toxicity profiles of sulfoxaflor are consistent with the criteria for Schedule 6. The delegate accepts ACCS advice that the human relevance of the observed hepatocellular adenomas and Leydig cell tumours in rats is adequately addressed by the MOA studies.
  • the proposed product containing 24 per cent sulfoxaflor demonstrates an adequate margin of exposure (MOE) estimates for its use by workers when used with appropriate personal protective equipment (PPE). This, along with its reduced acute toxicity profile justifies inclusion of the product in a lower schedule (Schedule 5).
  • the basic recommendation that sulfoxaflor be included in Schedule 6 with a cut-off to Schedule 5, has been adopted, but a minor change to the Schedule 5 wording is proposed for consistency with other SUSMP entries relating to cut-offs.
Schedule 5 - new entry

SULFOXAFLOR in preparations containing 25 per cent or less of sulfoxaflor.

Schedule 6 - new entry

SULFOXAFLOR except when included in Schedule 5.

Footnotes

1-6Scheduling Policy Framework for Medicines and Chemicals

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