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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2016

Scheduling medicines and poisons

12 May 2016

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1.16 Methyldibromo glutaronitrile

Part A - Interim decisions on scheduling proposals referred to an advisory committee (March 2016)

1. Advisory Committee on Chemicals Scheduling (ACCS#16)

1.16 Methyldibromo glutaronitrile

Referred scheduling proposal
  • To resolve an apparent ambiguity between the Schedule 6 and Schedule 10 entries relating to duplication of the exception clause "except in preparations intended to be in contact with the skin, including cosmetic use"
Scheduling application

On 30 November 2015 the chemicals Delegate identified possible ambiguity in the current SUSMP entries for the chemical. The proposal is to amend the Schedule 6 entry to remove the exception clause "except in preparations intended to be in contact with the skin, including cosmetic use".

Specific issues/questions raised by the delegate

The reasons the Delegate has referred this substance to the Committee were to seek advice on appropriate amendments to remove ambiguity in the current Schedule 6 and 10 entries for MDBG.

In previous versions of the SUSMP, listing in Appendix C was used to designate specific uses of substances that should be prohibited. The previous heading of Appendix C was:

SUBSTANCES, OTHER THAN THOSE INCLUDED IN SCHEDULE 9, OF SUCH DANGER TO HEALTH AS TO WARRANT PROHIBITION OF SALE, SUPPLY AND USE.

In some cases, this message was directed to the relevant regulatory agency (e.g. TGA for therapeutic uses), while it is understood that some State/Territory jurisdictions automatically applied controls analogous to those of Schedule 7 to control those uses of substance listed in Appendix C.

Previous versions of the Poisons Standard (SUSMP4 and 5, 2013-2014) used a 'dagger' to designate substances in Schedules 4, 5 and 6 that were also listed in Appendix C, with a page header that drew attention to those listings ('Substances marked † are listed in Appendix C'). When Appendix C was transitioned to Schedule 10 in SUSMP6 (2015), the 'dagger' designation was discontinued. Instead, exception clauses were added to Schedule 10 listings for substances where the primary listing was in Schedules 4, 5 or 6. The addition of these exception clauses was designed to follow the 'cascading principle' where listing of a substance in the most restrictive schedule is used as the primary listing, with cross-references to listings in other less restrictive schedules designated by exception clauses.

The delegate is concerned that the cascading principle may be inappropriate for substances listed in Schedule 10, that was intended to apply quite selective controls, and that the use of exception clauses in Schedule 10 could introduce ambiguities.

The Delegate has sought advice on the following questions:

  • The current Schedule 10 entry for methyldibromo glutaronitrile sodium is intended to prohibit its use in products (including cosmetics) that are intended to be directly applied to human skin. For other uses, the Schedule 6 entry applies relevant controls. Does the ACCS agree that the exception clauses added to both the current Schedule 6 and 10 entries is potentially ambiguous (The S10 exception clause was not included in previous versions of the Appendix C)?
  • Does the ACCS agree that deletion of the exception clauses in either the Schedule 6 or 10 entries will fix the ambiguity? Is the exception clause in the Schedule 6 entry potentially the one that should be deleted because it appears to exempt products applied to the skin from any scheduling controls.
  • If it is impractical to re-introduce the 'dagger' system of identifying substances in Schedules 4, 5 and 6 that are also listed in Schedule 10, does the ACCS consider that re-introducing a page header for these schedules that could draw attention to possible listing in a more restrictive schedule. Such wording could be 'Substances in this schedule may also be listed in Schedule 10, where additional restrictions may be applied. Readers are urged to consult the index for other listings'. Alternatively, the heading of Schedule 10 could include words like: 'Listing in Schedule 10 imposes restrictions additional to those that may result where the substance is listed in other schedules. Readers are urged to consult the index for other listings'
Substance summary

How to access a pdf document

Please refer to the NICNAS Chemical assessment report for methyldibromo glutaronitrile (pdf,293kb) which is available from the NICNAS website.

Figure 13. Structure of methyldibromo glutaronitrile

Figure 13. Structure of methyldibromo glutaronitrile

Current scheduling status

Methyldibromo Glutaronitrile is currently listed in Schedules 6 and 10 and Appendix F.

Schedule 6

METHYLDIBROMO GLUTARONITRILE except in preparations intended to be in contact with the skin, including cosmetic use.

Schedule 10

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use except when in Schedule 6.

Appendix F, Part 3

Warning statement 28

Safety directions 1, 4, 7

Relevant scheduling history

Methyldibromo glutaronitrile (MDBG) was first considered for scheduling in June 2008. Due to an administrative error the substance was reconsidered at the October 2008 meeting.

The Committee decided: to include MDBG in Appendix C when in preparations intended to be in contact with the skin, including cosmetic use; and in Schedule 6 except when in preparations intended to be in contact with the skin, including cosmetic use. Appendix F warning statement 28 and Safety directions 1, 4 and 7 were also agreed.

The current wording of the Schedule 10/Appendix C entry was published in the first version of the Standard in 2015 <https://www.legislation.gov.au/Details/F2015L00128>.

Pre-meeting public submissions

Two public submissions were received. The first submission did not support the proposed amendments. They noted that MDBG is entered in the ARTG ingredient list and is allowed in therapeutic goods as an excipient in OTC medicines. They requested that the ACCS considers exemptions (from either Schedule 6 or Schedule 10, as appropriate) for the use of the substance as an excipient in therapeutic goods, with a suitable cut-off concentration if appropriate. The second submission supports clarification of the current Schedule entries and included proposed wording for an amended Schedule 6 entry.

The public submissions are available at: Public submissions on scheduling matters.

ACCS advice to the delegate

In response to the Delegate's request, the Committee advised that the current schedule entries for MDBG were ambiguous. They recommended that the entries could be improved by simplifying the cross reference between the entries as follows; for the schedule 6 entry, replacing the exception clause with “except when in Schedule 10”, and for the Schedule 10 entry, referring to the use that is subject to prohibition and deletion of reference to the Schedule 6 entry.

The Committee recommended the following amendments to the Poisons Standard:

Schedule 6 - Amend entry

METHYLDIBROMO GLUTARONITRILE except when in Schedule 10

Schedule 10 – Amend entry

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use.

The Committee recommended an early implementation date (1 October 2016).

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: f) amendments clarify which uses are subject to prohibition in Schedule 10.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACCS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors16;
  • Other relevant information.
Delegate's interim decision

The delegate notes, and accepts, ACCS advice to amend the Schedule 6 and 10 entries for methyldibromo glutaronitrile , since they appeared to contain mutually exclusive exemption clauses. The purpose of the Schedule 10 entries was to prevent the availability of products that would be directly applied to human skin. Retaining the existing Schedule 6 entry would be consistent with SPF criteria for such a listing and would ensure that labelling and supply restrictions for other types of products are retained.

The delegate notes the industry submission that seeks an exemption from the entries where the substance may be used in therapeutic goods. The chemicals scheduling delegate has therefore referred the matter to the medicines scheduling delegate for further consideration.

The proposed implementation date is 1 October 2016. This is a clarification of existing schedule entries, so it should be implemented in the earliest revision of the Poisons Standard.

The delegate considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (b) the purposes for which a substance is to be used and the extent of use of a substance; and (c) the toxicity of a substance.

Schedule 6 - Amend entry

METHYLDIBROMO GLUTARONITRILE except when in Schedule 10

Schedule 10 – Amend entry

METHYLDIBROMO GLUTARONITRILE in preparations intended to be in contact with the skin, including cosmetic use


Footnotes

  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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