Obligation in Regard to Genetically Modified Organisms

Proprietors of licensed animal remedies or registered pesticides are advised that the new organisms provisions of the Hazardous Substances and New Organisms (HSNO) Act 1996 have been in effect since April 1998. All genetically modified organisms are subject to those provisions.

Separate obligation
Genetic modification of organisms was not a factor that was relevant to licensing or registration under the Animal Remedies and Pesticides Acts. In addition, there was no statutory obligation to withhold a licence/registration until an ERMA NZ approval was issued. Therefore, commencement of the new organisms provisions of the HSNO Act did not invalidate existing licences/ registrations, but it has imposed a separate statutory obligation. All ‘genetically modified organisms’ require an approval from ERMA NZ. Licensees/registrants must not presume that having a current licence/registration meets that separate obligation.

Definition
Under the HSNO Act, the relevant definition of an ‘organism’ is broader than the traditional view. In addition to a whole, viable living entity, an organism may also be:

• a genetic structure, other than a genetic structure derived from a human being, that is capable of replicating itself, whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity; and
• a reproductive cell or developmental stage of an organism.

It must also be noted that not all organisms that have been modified fit the definition of a ‘genetically modified organism’ as specified in the HSNO Act and its Regulations. The determinant factor is likely to be if any recombinant technology or techniques were used in any stage in the development/modification of an organism.

Transition
When the ACVM Act commences the ACVM Group must not register a product containing a genetically modified organism without first confirming that an ERMA NZ approval has been issued. Therefore, the Group will not be able to transfer existing licensed/registered trade name products containing organisms to ACVM registrations unless either:

• each organism is not a genetically modified organism; or
• there is an approval issued by ERMA NZ for the release of any particular genetically modified organism present in the trade name product.

The ACVM Group will send a letter to licensees/registrants of products containing live organisms, advising them of their responsibility to know the genetic modification status of any organisms in their products. However, because of the limitations in the trade name product database, the Group may not identify every product that contains organisms. Licensees/registrants are advised to take the initiative and contact ERMA NZ if their products contain genetically modified organisms or if they are uncertain as the genetic modification status of the organisms in their products. To facilitate the transition process, proprietors of licensed/registered products containing organisms are also encouraged to advise the ACVM Group of the genetic modification status of the organisms in their product.