F2024C00396 Chemical information holder when introducer does not know

[Mike Dewhirst]

1. An eligible INCI name has been added to the mix of permissable names if CAS and IUPAC names are not known. No change to the software is required beyond slightly updating the help-text.

2. If none of the above is known to the introducer then we need a name of a person in the Chemical information holder (CIH) field who has provided or is expected to provide identifying information to the Executive Director.

3. We also need a note indicating the basis of the expectation that the person named will give the identifying information to the Executive Director if requested.

The records being kept are actually in the Chemintro Data report.

Thus, with the Information availability field set to "Introducer does not know ..." and with a non-blank Chemical information holder field, the only two changes to the software will be to:

Produce a templated Chemical information holder: Basis of expectation note where the Chemical information holder field is not blank.

and

Under all circumstances it will be an error if all three of CAS, IUPAC and INCI names are blank and the Chemical information holder field is also blank.

Correction here: There is no point raising an error if the only issue is the user happens to be saving data entered before (yet) entering those names. In fact the error will will be raised if the user selects "Introducer does not know ..." in the Information availability field while simultaneously leaving the Chemical information holder field blank.

If there is a CAS number and the three fields are blank it will certainly be anomalous but not an error. CAS number appears to satisfy AICIS requirements.

These April 2024 amendments to the Rules make similar changes to record keeping (mentioned in a comment below) where the basis of belief also needs to be documented. At this stage, a single note for documenting that basis ought to be sufficient.

[Mike Dewhirst]

This ticket also covers <= 10kg introductions for R&D

[Mike Dewhirst]

The current Chemintro MoU design imperative was that no overseas supplier would accept being bound by a written undertaking to reveal trade secrets to a government body. They would sooner scrap their Australian market.

Larger introducers would obtain source documentation or not bother importing in the first place. Only smaller introducers are likely caught by written undertakings.

These April 2024 amendments suddenly make the MoU exactly the instrument required for those smaller players.

Previously, all introductions where the introducer didn't hold source documentation were subject to a written undertaking.

The big change is source documentation is only required if AICIS request it for particular chemicals.

Now, the introducer only needs to document the basis of their belief that it will be provided.

Such belief cannot be held unless the overseas supplier knows what might be requested**

The local introducer whose business depends on the supplier not scrapping their Australian market can quite legitimately and honestly say to an overseas supplier ...

"Sign this MoU which describes information which MAY be requested by AICIS for this particular chemical. Further, this MoU will be the basis of my belief that, also understanding the particular consequences involved, you intend to provide that information if AICIS requests it."

As indicated, the MoU sets out the consequences of failing to provide AICIS-requested information.

There is therefore a real and properly informed choice to be made by the overseas supplier in their role as the Chemical Information Holder - if AICIS request the information.

[Mike Dewhirst]

• The templated "Basis of expectation" note is auto-created if there is a value in Chemical information holder
• An error is raised if there is no value in Chemical information holder when the Information availability field indicates there should be, ie., the introducer does not have the information.
• The MoU has been simplified (and will evolve in response to user comments)