Dear Environmental Protection Authority,

I write as a New Zealand citizen.

In your application decision made 11 February 2021 (APP204176) "To determine under section 26 of the Hazardous Substances and New Organisms Act 1996 if the SARSCoV-2 vaccine BNT162b2 (COMIRNATY) is a new organism" (source: https://www.epa.govt.nz/assets/FileAPI/h...), it was concluded that "that the SARS-CoV-2 vaccine BNT162b2 (COMIRNATY) is not a
new organism for the purpose of the Act.".

Given the application made the following considerations and determinations:

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13. "...The Committee therefore concluded that BNT162b2 cannot be considered to be a virus and, by extension, BNT162b2 cannot be a micro-organism."

15. "...The Committee therefore rejected the notion that BNT162b2 could be considered to be a ‘genetic structure'"

16. "...The Committee further considered description (e) and agreed that BNT162b2 is a genetic structure that is artificially created. Because such an mRNA is constructed so that it can neither replicate itself nor re-form into the structure of the vaccine formulation, it does not constitute “…a developmental stage of an organism”."

18. "...Therefore, the Committee further determined that it was not necessary to consider BNT162b2 against the definition of a new organism (section 2A of the HSNO Act)."

19. "...The Committee noted that none of the other definitions of “organism” in the Act are applicable to BNT162b2."

20. "...The Committee considered that the modifications made to the chemistry of the BNT162b mRNA molecule relative to a naturally-occurring mRNA ... had no bearing on the relevant criteria in the definition of ‘organism’ in the HSNO Act."

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It is clear that a 'new organism' determination was warranted.

However, given this determination and the fact that the product SARSCoV-2 vaccine BNT162b2 (COMIRNATY) contains novel nano-material (ALC-0315 and ALC-0159) and potentially toxic/flammable/explosive substances:

Can you please explain why this product would not be classed as a substance and/or hazardous substance under the HSNO Act 1996 and provide any documentation/correspondence held by the EPA or related entities which would lead to not determining as such?

Note: As a reference to it's hazardous nature, I refer to Pfizer's own Safety Data Sheet under 5.2 Special hazards arising from the substance or mixture:

- Fine particles (such as mists) may fuel fires/explosives
- Formation of toxic gases is possible during heating or fire

Source: https://safetydatasheets.pfizer.com/MyDo...

Yours faithfully,

Maxwell