Keep an eye on hazardous substances rule changes

September 2003

Industry needs to keep an eye on new rules for hazardous substances and new organisms, or live with the consequences - and the costs, says Theresa Le Bas.

In essence, the Hazardous Substances and New Organisms (HSNO) Act 1996 is a good thing. It was designed to simplify management of the manufacture and importation of substances and organisms, previously regulated by no less than eight different statutes.

In practice, it centralises assessment and regulations in one statute and through one body - the Environmental Risk Management Authority, or ERMA.

On the hazardous substances side, the Act pulls together lots of nasty things - and some not so nasty things - that were previously regulated by a complex web of Acts, regulations and Gazette notices.

The new organisms section of the Act may raise the spectre of genetic modification, but also includes the application process for the import of any normally evolved plant or animal that is new to New Zealand - an immigration policy for seeds, viruses and fruit bats, if you like.

This control was strangely lacking before HSNO, apart from various restrictions in the Plants and Animals Acts. So, theoretically, if you wanted to import water buffalo for your lifestyle block in Ramarama, you could with relative ease compared to the legal regime that now applies.

What isn't so good about the Act is the transfer process required to bring thousands of existing substances into the HSNO framework. As substances are transferred to the new regime, they have to be assessed and then categorised according to their hazardous properties.

After categorisation, regulations have to be written - or rewritten - setting "cradle to grave" rules for every individual substance.

Add to this the list of existing substances that were outside the scope of the previous legislation. They too need to be assessed, regulated and moved into the HSNO regime.

In parallel, ERMA has to process all applications for new substances and organisms.

It's a huge job. At present, ERMA hopes to have all substances regulated and brought under the new HSNO regime by July 2004.

The current deadline is thought optimistic by many in the industry, although the Government has proposed a new strategy to simplify the transfer process for some existing substances and for less dangerous new substances.

However, a discussion paper on these new processes is only expected in November 2003, with implementation the following year.

In the interim, transitional arrangements are in place - which means you need to comply with existing regulations and statutes until substances are transferred to the new regime.

However, don't let the sedate pace of transfer lull you into a false sense of security or ignorance.

Anyone who imports, manufactures, stores, uses or disposes of substances covered by the Act has a simple choice: get involved in the consultation on the regulations or live with the results - and the compliance costs - once the regulations have been approved.

Regulations range from transportation of substances in bulk to labelling and packaging - are your containers sufficiently child-proof, for instance? How prominently is the word "poison" displayed on your label?

So what action should you take? One good point is that ERMA has a comprehensive website at www.ermanz.govt.nz, which will help you monitor the situation.

If you deal with hazardous substances, you first need to check what is covered by the new Act. There are some obvious - and some not-so obvious inclusions.

You might have guessed that arsenic, mercury and sulphuric acid would be listed as toxic substances, but would perhaps be more surprised to find avocado oil, beeswax, ceramics, lanolin, numerous essential oils, oxygen, silver and even good old vitamin B12 - so be careful how much you keep in the bathroom cabinet.

Substances previously regulated as explosives, dangerous goods, toxic substances including deadly, dangerous or standard poisons, pesticides and animal remedies now fall under the HSNO regime.

ERMA has already considered over 50% of pesticides used in New Zealand. Changes are already in force for those who use poisons to control possums, vermin or other animals.

Once you have identified substances that you use or handle, check the current timescale for consultation and confirmation of regulations.

In some cases, ERMA has held consultation seminars on proposed regulations. In most cases, a consultation document is issued with submissions requested from interested parties - your chance to have your say.

Whatever forum is available, it is essential that you keep a watching brief on the ERMA website for substances that affect your business.

Given the wide range of uses that substances can be put to, it would be near impossible for ERMA to maintain expertise across all industries and sciences.

In some cases, this has resulted in restrictive regulations being proposed which suit one industry, but were potentially disastrous for another. Industry involvement is therefore critical.

When dealing with organisms, the Act is slightly clearer. It covers anything capable of replicating itself - from bacteria through seeds and plants to elephants and octopuses.

Interestingly though, the HSNO Act's definition of an organism differs from the scientific community's definition, for instance the inclusion of viruses, so further debate may be required.

Any organism that existed in New Zealand before the new organisms part of the Act came into force on 29 July 1998 is exempt.

To import any other organisms, you will need to get ERMA and MAF approval before you bring it in. These rules also apply to any genetically modified organism.

There is an emergency process - for instance, if virus samples were required by a laboratory to try and counter an emerging disease, as happened with SARS earlier this year.

The same requirements apply to anyone wishing to import or manufacture a new and potentially hazardous substance.

The application process raises concerns about the security of the intellectual property in new organisms or substances.

An ERMA application will require full disclosure of the nature, components, intended use and manufacture of a substance or organism. There is an intention that the ERMA process be completely transparent - including the publication details of all products online.

It is still unclear how ERMA will implement this process, but it obviously raises commercial concerns for any company or individual investing time and capital into hazardous substances or new organisms.

Lastly, if you are making decisions about producing or investing in the production of anything likely to be covered by HSNO, get onto ERMA's website sooner rather than later.

First published in Biotech Unlimited, September 2003.