Problems with Exotic Reptile Legislation/Regulation

Problems with Exotic Reptile Legislation/Regulation and Administration
Processes with respect to the Venom Industry
Peter Mirtschin Venom Supplies Pty Ltd

Our business represents 3 companies namely Venom Supplies Pty Ltd, Antiven Pty Ltd and Venom Science Pty Ltd. Venom Supplies Pty Ltd produces freeze dried venoms, venom fractions, antibodies to the fractions and genetic material from snakes, spiders, bees. Antiven Pty Ltd is a dedicated antivenom producer. Venom Science Pty Ltd develops Intellectual Property surrounding the uses of venoms and their fractions or derivatives. We are involved with the keeping and venom extraction from exotic snakes which is only made possible by our linkage with a government institution called the Insutitute of Medical & Veterinary Science. All 3 companies are affected by the various laws, regualations and administrative policies and practices
affecting exotic snakes.

Background

Venoms are mixtures of many components. They are like soups. Some of the types of components are:
Components causing necrosis
The exact cause of necrosis is still unknown. Whether it is a single component or caused by multiple components, is yet to be determined. Venom Supplies Pty Ltd and the IMVS are currently carrying out investigations to try and determine the causes and evaluate different strategies for treatment and determine the efficacy of antivenoms in reducing necrotizing effects.
See photos of necrosis

Neurotoxins
Neurotoxins block signals from the brain to the muscles. There are a number of types. The most common are the presynaptic and postsynaptic neurotoxins.
See diagram and photo of neurotoxins

Myotoxins
Myotoxins are toxins which break down muscle cells. Not only does this impair muscle function but it causes myglobin to leak into the blood stream and can cause kidney blockagae and failure.
See Pictures of myotoxic damage

Haemotoxins
Haemotoxins are toxins in venoms that cause interference with blood clotting, damage blood vessels or blood cells.. Some of these are enzymes have proved invaluable in haematology. There are a number of commercial diagnostics currently available. Ecarin, Bothropase, Protac and textarin are just some made from different venoms.

Stypven, made from Russells viper venom, was the first therapeutic treatment for haemophilia. Ancrod, made from the Malayan pit viper venom is used widely to break down clots and is currently one of the best drugs used in stroke management.

Clotting factors

Clotting factors or procoagulants cause blood clotting. They do this by activating various blood factors in the clotting cascade.
See pictures and diagram of procoagulants

Spheroechonocytosis
Many phospholipase components in snake venoms cause deformation and damage to red blood cells. We have studied this property and found that it is widespread in venoms of many types. This type of problem has the potential to cause ischaemia to vital organs which may lead to multiple organ failure.
See picture of spheroechinocytosis

Effects on blood vessels
Many venoms affect blood vessels. Most cause vasodiltation. There is at least one venom, from the burrowing asp from the Middle East, that causes vasoconstriction.
See diagram showing vaso-acting toxins.

To be successful in marketing venoms and venom derivatives our businesses needs to offer:
Competitive Prices
Fast Delivery times
Broad range of Venoms
Good Backup Service
The Federal & State Laws/Regulations/policies affect all of the above.
Supply of Exotic Snake Venoms
Importation of stock
There are 2 methods of gaining approval to import stock.

Gaining Approval to import Under the current arrangements, our businesses
follows the steps below to obtain new stock and gain approval.

The steps are similar in all states. The state agencies use a variety of names in the respective states.


Steps required to gain approval and keep new stock if for scientific purposes in SA
NB. State authorities have different names in other states.


Steps required if importing and gaining approval to keep new stock for other purposes in SA (zoos, reptile parks).
NB. State authorities have different names in other states.
Ongoing Compliance
Once approval to keep exotic snakes has been given, there are ongoing comitments with EA, APCC and AQIS.

APCC
Annual stock take
Movement approvals/transfers

AQIS
Full permit renewal each year - comprehensive 5 page submission
Fee $550 per year
6 monthly inspections
Restrictions on stock movement - includes native species.
Movement approvals - transfers, veterinary.
The restrictions placed on our laboratory means that any snakes kept in the same building (exotics and native species) are covered by the restrictions. We agree with this for a reasonable quarantine period after aquisition of new snakes. . We have 2 Naja melanoleuca which have been in Australia since 1985 and are still quarantined for no other reason than AQIS will not specify diseases of concern and therfore the snakes cannot be checked. The snakes have had no indications of any infectious problems other than a salmonella infection which was treated in one of the snakes some years ago. When this restriction was placed on us, we had to destroy hundreds of newly born native snakes because we did not have the facilities to care for them whilst awaiting an imposed 90 day quarantine period.



Snakes frozen due to AQIS restrictions

Whilst we believe the various disease controls on exotic snakes are reasonable, we do not believe that they should be indefinite.
Environment Australia Environment Australia (EA) administers CITES restrictions on CITES listed species. The venoms that this legislation affects with the species we keep or trade with either directly or with our overseas partners, is venom derived from all Asian Naja species and king cobra Ophiophagus hannah. Both genera are listed on CITES schedules and therfore any product derived from these species is affected by CITES controls. One of the most serious problems is the affect it has had on a product made from Naja kaouthia venom called cobra venom factor (CVF).



Naja kaouthia is one of the commonest snake species throughout Asia and is responsible for many deaths and extensive morbidity throughout its range. It’s listing on CITES schedules is bewildering and appears to be more for political reasons rather than conservation motives.

Administrative procedures
Initially a submission to EA is required to obtain a permit to export the venom.
There is an annual permit required which acknowledges the venom was only obtained from snakes bred in a captive breeding colony - An annual fee is required.
There is also a permit required for each consignment - $150.00/consignment.
The customer in the importing country (from CITES signatory countries) also is required to obtain an import permit.
Uses of CVF

CVF is used widely in immunology laboratories for removal of complement from serums both in-vivo and in-vitro in research settings. See diagram of CVF uses

One of the important areas of research
is in organ transplant. Complement suppression for a period of time after organ transplant, dramatically improves the long term organ acceptance.
The outcomes of the CITES Controls
Initially, export of CVF and Asiatic Naja spp. venom from Australia stopped. The rest of world continued to export these products unfetted. Later the rest of the world came into line and more or less enforced control of venom products from Asiatic cobras as specified by CITES controls. Now, only Asian countries trade in Asian Naja spp. venom Their success is unknown but they produce vast quantities of this venom.

There is a world shortage of CVF made from Naja kaouthia venom.

Antivenoms

Currently there is a world shortage of antivenoms.


Many producers are finding the increased liability risks in relatively small markets is unwarranted. There has also been an unprecedented increase in compliance costs which are the same as for drug and vaccine products but since the markets are significantly smaller, the returns are not as great.

Venoms, whilst they appear to be costly, they have been one of the lowest costs in antivenom production. This is changing rapidly.

The costs of producing venoms is escalting rapidly with new safety health and welfare compliance costs, difficult to obtain and expensive public liability insurance and the raft of governmental compliance permit restrictions and costs on obtaining, transferring and keeping snakes in captivity most of which bear little relevance to the conservation requirements of the species concerned.

Universal Elapid/Sea Snake Antivenom
Antiven Pty Ltd and Venom Science Pty Ltd and the Institute of Medical & Veterinary Science (IMVS) have been working on new antivenom developemnt for the last 7 years and is currently registering a new veterinary brown snake antivenom against the Australian Pseudonaja genus and in the last 2 years have developed a new anti-elapid antivenom.



This concept was initially proposed by Calmette at the end of the 19th Century but he was unable to demonstrate efficacy against venoms that weren’t used as antigens to make the antivenom. Our sucessful trials, although still preliminary, are extremely encouraging given we have only tested crude serums to date. We have tested the antivenom against a range of of venoms including: cobra venoms, kraits, sea snakes and a number Australian snake venoms. We have used a number of in-vitro and in-vivo test systems. Further serum purification will inevitably produce even more superior results.



Our group of companies support controls that cater for:
Environmental risk
Primary Industry risk
Security
Disease risk
Threat to Amenity
Public safety risk
Animal welfare concern


Unfortuantely these controls are duplicated and sometimes triplicated across State and Federal government departments.

Concern	AQIS	EA	APCC	VPC	State Fauna	Local Govt.
Risk to Environment	Y	Y	Y	Y	Y
Risk to Primary Industry			Y
Security	Y	Y	Y	Y	Y
Disease potential	Y				Y
Amenity						Y
Public Safety			Y			Y
Animal Welfare			Y		Y

The duplication, triplication and quadruplication of controls by State and Federal government bodies, causes increased costs to government (taxpayers) and the applicant and also increases significantly the time taken to process applications. It is a major disincentive for applicants. This overlap does not produce better controls (see conference conclusions).
The Federal Government also believes that biotechnology is an important feature of the Australian economy.



Senator the Hon Nick Minchin Minister for Industry, Science and Resources says:
“Commonwealth Government support for biotechnology R& D... exceeds $250 million per annum”.

“Biotechnology... is likely to play a key role in Australia’s future prosperity”.

To Continue to do this work efficiently:
We need a rationalised compliance system in Australia