Determination of SARSCoV-2 vaccine BNT162b2 (COMIRNATY)
Maxwell made this Official Information request to Environmental Protection Authority
The request was successful.
From: Maxwell
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:
==============================
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."
==============================
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
From: Ministerials
Environmental Protection Authority
Good afternoon
Thank you for your request of 8 October 2021.
This has been logged and assigned to a team member to draft a response.
Kind regards,
Lisa MacKenzie (she/her)
Official Correspondence Advisor, Government Engagement and Official Correspondence
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Our New Zealand Business Number Is 9429041901977.
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-----Original Message-----
From: Maxwell <[FOI #17092 email]>
Sent: Friday, 8 October 2021 9:31 am
To: Ministerials <[EPA request email]>
Subject: Official Information request - Determination of SARSCoV-2 vaccine BNT162b2 (COMIRNATY)
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:
==============================
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."
==============================
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
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From: Lisa Mackenzie
Environmental Protection Authority
Good afternoon
Please find attached a response to your request.
Kind regards,
Lisa MacKenzie (she/her)
Official Correspondence Advisor, Government Engagement and Official
Correspondence
+64 4 474 5442
[1]EPA_logo_teal_96dpi
Follow us on [2]Facebook, [3]Twitter and [4]LinkedIn.
Our New Zealand Business Number Is 9429041901977.
This email message and any attachment(s) are intended for the addressee(s)
only.
If you receive this message in error, please notify the sender and delete
the message and any attachment(s).
-----Original Message-----
From: Maxwell <[5][FOI #17092 email]>
Sent: Friday, 8 October 2021 9:31 am
To: Ministerials <[6][EPA request email]>
Subject: Official Information request - Determination of SARSCoV-2 vaccine
BNT162b2 (COMIRNATY)
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:
[7]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:
==============================
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."
==============================
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:
[8]https://safetydatasheets.pfizer.com/MyDo...
Yours faithfully,
Maxwell
-------------------------------------------------------------------
This is an Official Information request made via the FYI website.
Please use this email address for all replies to this request:
[9][FOI #17092 email]
Is [10][EPA request email] the wrong address for Official Information
requests to Environmental Protection Authority? If so, please contact us
using this form:
[11]https://fyi.org.nz/change_request/new?bo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[12]https://fyi.org.nz/help/officers
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
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Erika Whittome left an annotation ()
Messenger ribonucleic acid is developed in vitro and this is in the Hazardous Substances and New Organisms Act 1996:
genetically modified organism means, unless expressly provided otherwise by regulations, any organism in which any of the genes or other genetic material—
(a)have been modified by in vitro techniques; or
(b)are inherited or otherwise derived, through any number of replications, from any genes or other genetic material which has been modified by in vitro techniques
No gazette notice can change what's in the Act either: https://www.legislation.govt.nz/act/publ...
Link to this