Risk Management 
Proposal  
Biological Products   
BIOLOGIC.ALL  
 
 
 
 
[Document Date]   
 
 
Disclaimer  
This risk management proposal does not constitute, and should  not be regarded as, legal advice. While every 
effort has been made to ensure the information in this document is accurate, the Ministry for Primary Industries 
does not accept any responsibility or liability whatsoever for any error of fact, omission, inte rpretation or opinion 
that may be present, however it may have occurred.  
© Crown Copyright - Ministry for Primary Industries  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Requests for further copies should be directed to:  
Minis try for Primary Industries (MPI)  
Agriculture and Investment Services  
Animal Imports  
PO Box 2526  
Wellington 6140  
Email: animal.imports@mpi.govt.nz  
Telephone:  04 894 0304  
 Biological Products  [Document Date ] 
 Contents  
 Purpose  1 
 Background  1 
 Objective  2 
 Requirements for all importations of biological products  2 
4.1 Culture media  2 
4.2 Polynucleotides  3 
4.3 Restriction enzymes  3 
4.4 Biological products derived from animal tissues (excluding blood)  4 
4.5 Products derived from eggs  5 
4.6 Products derived from blood  6 
4.7 Test kits  8 
4.8 Amino acids  8 
4.9 Products derived from microorganisms  8 
4.10  Small molecular weight fermentation products  9 
4.11  Antimicrobials/antibiotics  9 
 Products covered by other IHSs that have been integrated into revised biological products 
IHS 9 
5.1 Nonviable animal specimens from all countries  9 
5.2 Specified animal products and biologicals  10 
5.3 Teste d, filtered and irradiated foetal bovine serum, calf serum and bovine serum from 
Australia  11 
5.4 Foetal bovine serum, calf serum a nd bovine serum for further processing from Australia  11 
 Other biological products not covered by IRA 2005  12 
6.1 Agricultural Compounds and Veterinary Medicines  12 
6.2 Glyoxal as an alternative tissue fixative  13 
6.3 Commo dities eligible for clearance under another IHS  13 
 
 
 
 Biological Products  [Document Date ] 
Ministry for Primary Industries  1 
 Purpose  
The purpose of this document is to:  
 Show how options for the m anagement of risk o rganisms have been assessed.  
 Provide recommendations for import requirements.  
 Background  
Biological products are considered a risk commodity, with the potential to harbour exotic risk organisms . In 
December 2005,  the Ministry of Agricultu re and Forestry (MAF; super seded by the Ministry for Primary Industries 
(MPI )) completed a n import risk analysis (IRA) : Non-viable Biological Products, Microorganisms and Other Viable 
Cells into Ne w Zealand  (IRA 2005) . The IRA 2005 was used to develop  the Import Health Standard (IHS) for 
Biological Products ( Including Samples)  (2010).  
Part 1 of t he IRA 2005  looked at non -viable products that have been derived from living organisms , or are 
identical to products derived  from living organisms , and which are predominantly used by laboratories.  Due to the 
number of products offered for sale by suppliers of biological products  being too numerous, generic groups of 
products were  considered  within the IRA  2005 . 
The following categories of biological products  that are predominantly used in laboratories  were included in the 
IRA 2005 analysis : 
 Amino acids  
 Antimicrobials (antibiotics)  
 Biological products derived from animal tissues  
 Culture media  
 Polynucleotides  
 Products derived from blood  
 Products derived from eggs  
 Products derived from microorganisms  
 Restriction enzymes  
 Small molecular weight fermentation products (including  alcohols, organic acids and esters)  
 Test kits  
The scope of the IRA 2005  did not include the following categories of biological products as they fall under other 
legislati on not the Biosecurity Act 1993 : 
 Human medicines  (Medicines Act 1981 – administered by the Ministry of Health)  
 Veterinary medicines  (Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM Act) )  
 Food and food supplements ( Food Act 2014 ) 
 Agricultural products  (ACVM Act)  
The IHS  for biological products  contains generic import requirements. These requirements manage the 
biosecurity  risk of importing  biological  products  from all countries.  Guidance will be issued by MPI and this will 
provide commodity specific guidance information .  
Import requirements for microorganisms and cell cultures and other live cells from plants and animals (covered in 
Parts 2 & 3 of the IRA 2005) fall within other import health standard(s).  
Under Article 3.3 of the World Organisation for Animal Health (OIE) Agreement on the Application of Sanitary and 
Phytosanitary Measures (the SPS Agreement), risk manageme nt measures which provide a level of protection 
greater than provided by international standards may be imposed only when they can be scientifically justified on 
the basis of a risk assessment.  Biological Products  [Document Date ] 
Ministry for Primary Industries  2 For a detailed analysis of potential hazards and their risks please refer to the supporting document, Import R isk 
Analysis: Non -viable Biological Products, Microorganisms and Other Viable Cells into New Zealand which 
contains the relevant risk assessment and an analysis of  risk management options  for each risk commodity 
group . 
The following biological products , predominantly used in laboratories,  which were included in the preliminary 
hazards list were found to be of negligible concern and were not considered to be potential hazards requiring 
further investigati on: 
 Amino acids  
 Antimicrobials (antibiotics)  
 Small molecular weight fermentation products  
The IRA 2005 concluded that risk management measures were justified for the following imported non -viable 
biological products:  
 Products derived from blood  
 Products de rived from eggs  
 Products derived from microorganisms  
 Products derived from animal  tissues  
 Objective  
The objective is to effectively manage biosecurity risks associated with the import of  non-viable biological 
products , consistent with New Zealand’s domesti c legislation and international obligations.  
 Requirements for all importations of biological products  
(1) This section covers the biological products considered in the IRA 2005, discusses the risk management 
options presented and makes a recommendation for inc lusion in the IHS.  
(2) The IRA 2005 has a section titled ‘clearance to enter New Zealand ’. It states that biological product 
importers must have a valid import permit which may document any specific restrictions that apply. The 
IHS for biological product s currently does not have this requirement for all classes of product. In general 
import permits  are only issued for products that require direction to a transitional facility, or if there are post 
arrival conditions, or if there is a Chief Technical Officer  (CTO ) direction that need s to be communicated. It 
is intended that this risk management proposal (RMP) reviews and identifies  biological products which 
pose a negligible risk and may be cleared at the border without requiring an  import permit.  
(3) The resulting  IHS will require:  
a) No import permit for commodities  of negligible risk; or  
b) An import permit issued for commodities assessed by MPI and concluded to be of negligible risk but 
where that product is not listed as negligible risk within the relevant IHS (a general import permit); or 
c) An import permit issued for commodities  assessed by MPI  and concluded to pose a risk to New 
Zealand’ s biosecurity but for which the risk can be manage d by directing the product to be held in 
and/or used in a transitional facility (a restricted import permit).  
4.1 Culture media  
The IRA 20 05 states  that culture media should be classified according to the risk goods they are comprised of (for 
example, media containing whole serum, blood, or animal tissues that have not been sterilised should be 
assessed against the s pecific risk analysis for each  risk ingredient ). 
Commercially manufactured and packaged f ormulated media and media ingredients which do not  contain whole 
blood or serum or animal ingredients  will be free from infectious pathogens. Therefore, these products do not 
need to be kept in a transitional facility and are elig ible for biosecurity clearance . Biological Products  [Document Date ] 
Ministry for Primary Industries  3 As the release estimation  in the IRA 2005 is negligible , risk management measures are not necessary for 
commercially manufactured and packaged pre -plated culture media . Sterile c ulture m edia products could be  
eligible for biosecurity clearance.  
4.1.1 Recommendation  
(1) Commercially manufactured and packaged non-sterile  culture media may be imported from any country  
when  accompanied by a signed and dated manufacturer’s declaration  (on manufacturer  letterhead  paper ) 
confirming  the product do es not contain any ingredients of animal origin, including blood, whole  serum, 
animal proteins or animal tissues . 
(2) Commercially manufactured and packaged sterile culture media (including those that contain animal 
serum, blood and proteins) may be imported from any country  when labelled for in-vitro use only and 
accompanied by a signed and dated manufacturer’s declaration (on manufacturer letterhead paper ) 
confirming the product has been sterilised . 
(3) Culture media , from any country, which is not commercially manufactured and packaged must be 
accompanied by an  import permit which requires the product to be held and/or used in an appropriately 
approved transitional facility (as listed on the import permit).  
(4) Culture  media for use  in the manufacture of veterinary medicines, animal feeds  or agricultural compounds  
(as defined under the ACVM Act) requires a  specific  biosecurity assessment by MPI  and, if MPI considers 
the risk can be effectively managed,  must be accompanied by an import permit . This includes sterile 
products.  
4.2 Polynucleotides  
The IRA 2005 states purified DNA or RN A not contained in a host is not a self -replicating organism.  Those gene 
sequences that have been cloned into live host organisms (including viruses, phages and cell cultures) are 
considered living organisms and should be imported as per the microorganism im port health requirements.  
As the IRA 20 05 concludes the risk of purified DNA and purified RNA being contaminated with viable source 
organisms  is negligible , risk management measures are not needed and such items could be eligible for 
biosecurity clearance without an import permit.  
 
Currently, these commodities fall on the negligible risk register in the current import health standard  (2010) . 
4.2.1 Recommendation  
(1) Purified DNA and purified RNA (naked) may be imported from any country.  
4.3 Restriction enzymes  
The IRA 20 05 discusses that r estriction enzymes, also known as restriction endonucleases, are produced from 
cultures of microorganisms.  
Although the restriction enzymes are not biosecurity hazards, they could be contaminated with pathogenic 
organisms. However, the likelihood that reputable commercial companies would offer contaminated restriction 
enzymes  is negligible.  
As the risk of restriction enzymes is estimated to be negligible  in the IRA 2005 , commercially manufactured and 
packaged restriction enzyme risk mana gement measures are not necessary and could be eligible for biosecurity 
clearance.  
4.3.1 Recommendation  
(1) Commercially manufactured and packaged restriction enzymes may be imported  from any country . Biological Products  [Document Date ] 
Ministry for Primary Industries  4 4.4 Biological products derived from animal  tissues (excluding blood)   
The IRA 2005 states the range of products that could be classified as biological products derived from animal 
tissue is so great that it is not feasible to consider single risk products. Instead, the general principles of the risk 
involved in importing t he substances should be taken into consideration.  This section excludes biological products 
derived from blood (refer to section 4 .6 of this document ). 
The source of the product, whether it is free from infectious pathogens, the extent of product purificat ion and the 
sterilisation process should be assessed. The IRA 2005  lists the following sterilisation processes:  
 Filtration using membranes with pore sizes 0.2 m will remove microorganisms, with the exception of 
viruses  and mycoplasma 1. 
 Gamma irradiation wi ll render viruses and other organisms non -viable but this method is rarely used on 
biological products offered for sale . 
 Appropriate time and temperature h eat treatment will destroy organisms of concern but will also 
denature many biological products.  
 Chem ical treatments are more commonly used to destroy viruses in blood products intended for 
medicinal human use. The assessed biological products catalogues did not make reference to this 
particular treatment . 
The laboratory -based catalogues used to help info rm the IRA 2005 included, but in no means are limited to, the 
following categories of commodities extracted from biological products of animal origin:  
 Enzymes  
 Hormones  
 Crude tissue extracts  
 Monoclonal antibodies  
 Molecules extracted from tissues  
 Fatty acids  
 Actin and myosin  
 Cholic acid  
It was surmised that  most of the products offered for sale in catalogues can be considered safe as they:  
 Are highly purified;  
 Are produced from animals that do not have organisms which are a biosecurity risk ; 
 Are produced usin g harsh methods that will destroy all microorganisms . 
The IRA 2005  exposure assessment discussed the  transmission of a pathogenic organism from a facility where 
the contaminated product is being used would only be possible if the product  was: 
 Transferred from the transitional facility to a location outside the transitional facility  where animals and / 
or plants are exposed to the biological product . 
 Injected into or administered to a live animal or  used to infect plants outside the transitional facility 
where it is being held and then transmitted to ‘in contact ' animals or plants ( for example,  embryo 
culture media containing serum  that is implanted into a recipient animal ). 
 Injected into or otherwise used in animals or plants in non -secure facilities and then transmitted in 
waste water, urine, faeces, etc. or by aerosol to animals or plants outside the laboratory . 
If commercially manufactured and packaged  products are being us ed in a laboratory’s appropriately approved 
transitional facility, the risk  of contamination of animals, people or the environment  is considered to be negligible . 
Because the commodities within the catalogues assessed  are sold for laboratory use, it would be unlikely that 
they would contain harmful viable microorganisms. However, the risk is still deemed to be non -negligible.  
                                                           
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3584481/  Biological Products  [Document Date ] 
Ministry for Primary Industries  5 Biological products derived from animal tissue intended to be used in animals need to be imported on an import 
permit which restricts  importation to a specific batch number(s). Additional requirements for the importation of 
such products would be needed. This includes, but is not necessarily limited to:  
 The health status of the donor animals and their herds and countries of origin,  
 Manufacturing methods, auditing of the manufacture process in the country of origin,  
 Contents of the compounded product,  
 Specified tests for freedom from infectious agents with the testing carried out by an i ndependent 
competent authority approved laborator y and not by the manufacturer or supplier . 
4.4.1 Recommendation  
(1) Commercially manufactured and packaged highly purified or sterilised laboratory reagents / products 
produced from animal tissues  (excluding bloods , serum , and serum proteins)  may be imported from any 
country  if accompanied by a signed and dated manufacturer’s declaration (on manufacturer letterhead 
paper ). The manufacturer’s declaration will need to confirm the laboratory reagents / products produced 
from animal tissues (exclu ding bloods, serum, and serum proteins)  are c ommercially manufactured and 
packaged highly purified or sterilised . 
(2) Catalogued and commercially manufactured and packaged products produced from animal products 
comprising of risk goods (excluding bloods , serum , and serum proteins) may be imported from any country 
when  accompanied by  an import permit  which  requires the product to be held and/or used in an 
appropriately approved transitional facility (as listed on the import permit).  
(3) Non-commercially manufactured  and packaged biological products derived from animal tissue (excluding 
bloods , serum , and serum proteins) may be imported from any country  when  accompanied by  an import 
permit  which requires the product to be held and/or used in an appropriately approved transitional facility 
(as listed on the import permit).  
(4) Non-purified products derived from animal tissues  (excluding bloods , serum and serum proteins)  may be 
imported from any country when  listed on an accompan ying import permit which requires the product to be 
held and/or used in an appropriately approved transitional facility (as  listed on the import permit).  
(5) Biological products of animal origin  derived from animal tissue intended to be used in animal s may be 
imported from any country  when  accompanied by  an import permit which directs the product  into an 
appropriately approved transitional facility  (as listed on the import permit) . Use of such products in or on 
animals requires additional permission from the CTO . 
4.5 Products derived from eggs  
The IRA 2005 excludes fertile hatching eggs from the scope. They are classified as living organisms  and are 
covered by a separate risk analysis and import health standard . 
Biological products derived from eggs were considered as a potential hazard due to the range of i nfectious 
diseases that can affect both animals and humans.  
The IRA 2005  reviewed laboratory -based manufacturer catalogues and found a range of biological products 
derived from eggs . Examples include:  
 Lecithin  
 Choline  
 Antibiotics produced in eggs  
 Egg yolk  emulsions  
 Egg yolks  
 Egg white  
 Cystatin  
 Avidin  
 Conalbumin  Biological Products  [Document Date ] 
Ministry for Primary Industries  6  Lysozyme  
 Egg white powder  
 Proteins derived from egg whites  
Products derived from egg and  sold for use in culture media (such as egg yolk emulsions)  are covered in section 
4.1 of this document . They  will be sterile and will be resterilised before use in media and again after use before 
disposal.  
Since there are a large number of products  derived from egg  and the production methods are not specified, the 
risk is assessed to be non -negligible.  
Additionally, the importation of products intended to be used in birds requires an import permit for each batch 
imported as well as any quality control requirements (the testing should be carried out by an independent 
competent authority  approved laboratory and not by the manufacturer or supplier). CTO approval would also be 
required to use the product(s) in animals  in a transitional or containment facility setting . Information regarding the 
health status of donor animals and their flocks, country of origin, manu facturing methods (including auditing  the 
manufacturing process in the country of origin) , composition of the compounded product and tests for freedom 
from infectious agents would need to b e provided at a minimum.  
4.5.1 Recommendation  
(1) Commercially manufactur ed and packaged highly purified, sterilised or chemically synthesised laboratory 
reagents or products produced from egg may be imported from any country. This would include most 
catalogue products . The shipment is to be accompanied by a signed and dated ma nufacturer’s declaration 
(on manufacturer letterhead paper ) confirming this.  
(2) Non-purified products derived from egg must be accompanied by an import permit  which  requires the 
product to be held and/or used in an appropriately approved transitional facility  (as listed on the import 
permit) .  
4.6 Products derived from blood  
The IRA 2005  states that all blood products are derived from a common source – therefore, the risks involved in 
importing non -purified and purified blood products is similar. The health status and species of the donor animals 
will impact on the likelihood the product is contaminated with harmful microorganisms (for example, bovine viral 
diarrhoea  type 2 has been isolated from  imported foetal calf serum ). 
Blood products include:  
 Serum  
 Antisera  
 Plasma  
 Hormones  
 Albumins  
 Globulins  
 Antibodies  
 Proteins derived from blood  
Antisera from laboratory animals  
The IRA 2005 discusses a ntisera from laboratory animals (such as mice and rabbits)  has a  negligible biosecurity 
risk as the rabbit and mouse viruses are not considered to be of importance to New Zealand . The  use in and/or  
on laboratory animals  must be in accordance with t he transitional facility standard  and requires CTO approval.  
After further consideration by MPI in 2019, the biosecurity risk of importing commercially manufactured blood 
products from laboratory animals (ra bbits, hamsters, guinea pigs, mice, and rats) into New Zealand for laboratory Biological Products  [Document Date ] 
Ministry for Primary Industries  7 use was reassessed. It was concluded that certain hazards may enter New Zealand via imported blood products 
from laboratory animals, deeming the risk of these products to be non -negligible.  
Products purified from blood  
Products purified from blood such as plasma proteins (albumin and globulin), hormones and affinity purified 
antibodies are less likely to be contaminated with microorganisms than non -purified serum and plasma.  
Produ cts derived from blood and intended to be used in and/or on animals  
Some animal products may be imported with the intention of using them in the manufacture or formulation of 
products that will directly be used in animals – for example, in the manufacture of embryo media. This involves  a 
higher risk  and needs to be assessed according to the individual components within the media.  
The IRA 2005  release assessment concludes without adequate manufacturer guarantees regarding the freedom 
of blood products from c ontaminating microorganisms (including viruses), the risk likelihood is non -negligible.  
Where the origin and manufacturing procedures are unknown, the likelihood that blood products  may carry 
infectious pathogens cannot be adequately assessed.  
Risk goods could be held and/or used  in an appropriately approved  transitional facility with a special condition 
noting that these products must be kept in a transitional facility and are not permitted to be injected or used in 
animals unless special clear ance has been obtained from the CTO.  
Biological products  derived  from blood that are intended to be used in animals need to be imported on an import 
permit which restricts importation to a specific batch number. Additional risk assessment undertaken before  the 
importation of such products would be needed. Additional information required to undertake this assessment may  
include, but is not necessarily limited to:  
 the health status of the donor animals and their herds and countries of origin,  
 manufacturing m ethods, auditing of the manufacture process in the country of origin,  
 contents of the compounded product,  
 specified tests for freedom from infectious agents with the testing carried out by an independent, 
competent  authority approved laboratory  and not b y the manufacturer or supplier  
4.6.1 Recommendation  
(1) Commercially manufactured and packaged highly purified or sterilised products for laboratory use that are 
derived from blood  (including antibodies, antisera, globulins, hormones)  may be imported from any 
countr y. The shipment is to be accompanied by a signed and dated manufacturer’s declaration (on 
manufacturer letterhead paper ). The manufacturer’s declaration will need to confirm the products for 
laboratory use are derived from blood (including antibodies, anti sera, globulins, hormones)  and are 
commercially manufactured and packaged highly purified or sterilised products .  
(2) Commercially manufactured and packaged a ntisera and antibodies from laboratory -raised  animals (guinea 
pigs, hamsters, mice, rabbits, rats) for laboratory use may be imported from any country.  A specific 
biosecurity risk assessment must be undertaken by MPI and , if the biosecurity risk assessment concludes 
the risk is effectively managed, a general import permit is required.  Otherwise, the pro ducts will require an 
import permit that requires direction to an appropriately approved transitional facility.  
(3) Commercially manufactured and packaged products  for laboratory use  (excluding test kits)  that comprise 
of risk goods  (including, but not limited  to, bovine serum albumin and foetal calf serum)  may be imported 
from any country as long as they are accompanied by  an import permit which requires the product to be 
held and/or used in an appropriately approved transitional facility (as listed on the imp ort permit) . 
(4) Non-purified  products derived from blood  may be imported from any country  as long as they are 
accompanied by  an import permit which requires the product to be held and/or used in an appropriately 
approved transitional facility, as listed on th e import permit . Biological Products  [Document Date ] 
Ministry for Primary Industries  8 (5) Products derived from blood or serum and intended for use a s veterinary medicines will need to be 
assessed as per ACV Ms in the IHS, and special conditions may be imposed.  
(6) Biological products derived from blood  intended to be used in animal s may be imported from any country 
as long as they are accompanied by an import permit which requires the product to be held and/or used in 
an appropriately approved transitional facility (as listed on the import permit).   Use of such products in or 
on ani mals requires additional permission from the CTO.  
4.7 Test kits  
The IRA 2005  acknowledges there are a very large number of test kits available for the diagnosis of animal and 
plant diseases a nd other analytical procedures. Test kits will be generally used in a  laboratory environment but 
certain types of kits may also be used in the field .  
Commercially manufactured and packaged test kits can be regarded as safe as long as they do not contain live 
organisms.  Therefore, these do not need to be restricted goods. Commercially manufactured and packaged test 
kits that contain live organisms should be assessed according to the most appropriate import health standard.  
As the risk of test kits that do not contain viable microorganisms is estimated to be negligible  in the  IRA 2005 , 
commercially manufactured and packaged test kits that do not contain live organisms could be supplied without 
requiring the test kits to be imported into, and used in, an appropriately approved transitional facility.  
4.7.1 Recommendation  
(1) Commercially manufactured and packaged test kits  intended for laboratory use and that do not contain live 
organisms may be imported from any country.  
(2) Commercially manufactured and packaged test kits that contain live organisms should be assessed 
according to the most a ppropriate import health standard.  
4.8 Amino acids  
The IRA 2005 considers  that the purification processes for amino acids will produce purified low molecular weight 
products which are free from contaminating viable microorganisms. The IRA 2005 concludes the ri sk of 
commercially manufactured and packaged amino acids is negligible with no necessary risk management 
measures required. Therefore, commercially manufactured and packaged amino acids could be eligible for 
biosecurity clearance.  
It should be noted t he IRA 2005 does not consider crude mixtures of amino acids and small peptides produced by 
hydrolysis of proteins to  be classified as amino acids. Such products are described as peptones or hydrolysates 
and should be assessed as per the section on culture medi a (section 6.4 of IRA).  
These  commodities fall on the negligible risk register in the current import health standard (2010).  
4.8.1 Recommendation  
(1) Commercially manufactured and packaged amino acids  intended for laboratory use may be imported from 
any country.  
4.9 Products derived from microorganisms  
The IRA 2005 states a  large number of enzymes and other biological products (mainly proteins) are offered for 
sale to laboratories  (products extracted directly from the tissues of animal s (including blood) and eggs have  been 
discussed in the relevant sections ). Most other products are derived from microorganisms, with the majority of 
these being proteins . Products derived from microorganisms also include s some long chain fatty acids , starch, 
sugars and  alcohol.  Biological Products  [Document Date ] 
Ministry for Primary Industries  9 Since the  medium the microorganisms grow on  is sterile, the only organisms that could contaminate the end -
product are the donor organism(s).  
The risk in the IRA 2005 is estimated to be negligible for the presence of viable contaminating microorganisms in 
purified p roducts.  Therefore, the implementation of risk management measure s is not justified. Products derived 
from microorganisms could be eligible for biosecurity clearance.  
4.9.1 Recommendation  
(1) Commercially manufactured and packaged purified products derived from microorganisms  and intended 
for laboratory use  may be imported from any country . 
4.10 Small molecular weight fermentation products  
The IRA 2005 states small molecular weight fermentation products include alcohols, organic acids and esters and 
concludes the likelihood small molecular weight products sold as highly purified products for lab oratory  use would 
contain contaminating unwanted organisms is negligible . 
For the purpose of the IRA  2005 , highly purified small molecular weight fermentation products are n ot considered 
to be potential risk goods for this analysis and could be eligible for biosecurity clearance . 
4.10.1  Recommendation  
(1) Commercially manufactured and packaged highly purified small molecular weight fermentation products  
for laboratory use  may be importe d from any country.  
4.11 Antimicrobials/ antibiotics  
The IRA 2005 considers all antibiotics derived from non -pathogenic microorganisms or those which are 
synthesised or semi -synthesised products. The IRA 2005  also states a ntibiotics produced from microorganisms 
are always purified.  
The IRA 2005 concludes the risk of antimicrobials/antibiotics  as being negligible with no necessary ris k 
management measures required . Antibiotics could be eligible for biosecurity clearance.   
Currently, these commodities fall on the n egligible risk register in the current import health standard (2010).  
4.11.1  Recommendation  
(1) Commercially manufactured and packaged antimicrobials/antibiotics for laboratory use may be imported 
from any country.  
(2) Antimicrobials /antibiotics intended for use as veter inary medicines will need to be assessed as per ACVMs 
in the IHS, and special conditions may be imposed.  
 Products covered by other IHSs  that have been integrated 
into revised biological products IHS  
5.1 Nonviable animal specimens from all countries  
Certain clauses from the  Import Health Standard  for Non-viable Animal Specimens from All Countries , 
INESPEIC.ALL  have been incorporated into the revised biological products IHS.   
In addition to the current requirements of INESPEIC.ALL , the following ha ve been inco rporated:  Biological Products  [Document Date ] 
Ministry for Primary Industries  10  The minimum percentage of fixative has been included (where relevant) . These  have been bolded in 
this RMP ; and  
 The requirement of a declaration of the percentage of fixative has been included (where relevant). The 
declaration will be either stated on the label of the container containing the preserved specimen(s ) or 
stated on a paper declaration accompanying the preserved specimen(s).  
 Specimens of animal tissue equal to, or less than, 2mm thick fixed in glyoxal.  
The following categories are e ligible for biosecurity clearance ( no import permit is required):  
 Whole animal specimens that have been preserved with a minimum of  10% liquid formalin or 70% 
alcohol.  
 Whole animal specimens accompanied by a certificate o f irradiation issued by an official government 
department or a recognised institution stating that the whole animal specimens have been subjected to 
a minimum dose of 5 mrad (50kGy)  and that the whole animal specimens have been sealed in a 
hermetically seal ed container and identified in a manner which can be reference d to the certificate of 
irradiation.  
 Specimens of animal tissues and animal faeces preserved in a minimum of  10% liquid formalin or 
70% alcohol.  
 Specimens of animal tissue less than 2mm thick fi xed in 2 to 4% glutaraldehyde for electron 
microscope imaging , OR larger samples fixed in 2 to 4% glutaraldehyde by intravascular active 
perfusion.  
 Microscope slides of animal tissue , bacteria and protozoa fixed onto glass microscope slides under 
glass coverslips . 
 Specimens of animal tissue equal to, or less than, 2mm thick fixed in glyoxal.  
The clauses from INESPEIC.ALL  that have not been proposed for incorporation  are intended to be included as 
part of the revision scheduled for the Import Health Stand ard: Ornamental Products of Animal Origin, 
INETROIC. ALL and within the I Personal Consignments of Animal Products , PERSONAL.ALL . 
5.2 Specified animal products and biologicals  
Certain clauses of the Import Health Standard  for Specified Animal Products and Biologicals (INEPROIC.ALL)  
have been incorporated into the revised biological products IHS. 
Under INEPROIC.ALL , the following categories are eligible for biosecurity clearance (no import permit is 
required):  
 [INEPROIC.ALL , clause 6. 6] Commercially manufactu red antibiotics, medicines and vaccines intended 
for human use from any country may be given clearance.  
 [INEPROIC.ALL , clause 6. 7] Products composed only of human tissue from any country may be given 
clearance .  
 [INEPROIC.ALL , part of clause 6. 9] Heparin and heparanoid from any country may be given clearance 
provided the product is commercially packaged.  
 [INEPROIC.ALL , clause 6. 15] The following surgical implants  may be given clearance:  
– Lonescu Shirley low profile cardiac valve prostheses manufact ured by American Edwards Labs, 
Santa Ana, California, United States of America  
– Mitroflow TM pericardial heart valves manufactured by MNZ Ltd, Richmond, BC, Canada  
– Unilab Surgibone manufactured by Unilab Inc, Hillside, New Jersey, United States of America   
– SJM Epic cardiac valve prostheses manufactured by St. Jude Medical Inc, United States of 
America  
– Pericardial Tissue Bioprosthetic Devices (of bovine and porcine origin) of USA or Australian origin 
only, manufactured by Edwards Lifesciences AG, Switzerla nd  
– CYPHER Sirolimus -eluting stent from Australia supplied by Johnson and Johnson Medical  
– Mastergraft Matrix, manufactured by Integra Lifesciences Corporation (ILC), Plainsboro, New 
Jersey  Biological Products  [Document Date ] 
Ministry for Primary Industries  11  
Clause 6.7 of INEPROIC.ALL has been included in the revised biol ogical products IHS under the section of Part 1 
relating to eligibility. Biological products derived from humans are not subject to the  IHS and are eligible for 
biosecurity clearance.  
Clause 6.15 of INEPROIC.ALL has been included and extended in the revise d biological products IHS under the 
section under Part 2 relating to biological products for human use.  
5.3 Tested, filtered  and irradiated foetal bovine serum, calf serum and 
bovine serum from Australia  
All of the Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine 
Serum from Australia , BOVFBSIC.AUS  has been incorporated into the revised biological products IHS.  
The importation requirements under BOVFBSIC.AUS  state:  
 Product must be imported pre -packaged ready for use by the end -user and sealed so that 
contamination cannot occur during transit.  
 The veterinary certificate completed by the exporting country’s Competent Authority must be in 
English.  
 The product must be subject ed to: 
– filtration to 0.22 micron  or les s and irradiation with a single or multiple irradiation dose totalling 5 
mrad (50 kgray); or 
– triple 0.1 micron membrane filtration; and  
– irradiation with a single or multiple irradiation dose totalling 2.5 mrad (25 kgray); and  
– testing to confirm absence of disease of mycoplasma, bovine virus diarrhoea, infectious bovine 
rhinotracheitis, bluetongue and parainfluenza -3 using the methods described in the relevant 
Australian standard or, in its absence, described by relevant OIE guidelines.  
5.3.1 Recommendation  
(1) Amende d to include New Zealand -origin serum  that is further processed in Australia . Otherwise, n o 
change to requirements of the Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine 
Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS . 
5.4 Foetal bovine serum, calf serum and bovine serum for further 
processing from Australia  
The majority  of the Import Health Standard for Foetal Bovine Serum, Calf Serum and Bovine Serum for Furth er 
Processing from Australia BOVSFPIC.AUS  has been incorporated into the revised biological products IHS. The 
exception s are the transitional facility clauses which are deemed to be a requirement of the transitional facility 
standard and are not importatio n requirements.  
The importation requirements under BOVSFPIC .AUS state:  
 Product must be imported pre -packaged ready for use by the end -user and sealed so that 
contamination cannot occur during transit.  
 An import permit is required.  
 The veterinary certificat e completed by the exporting country’s Competent Authority  and the 
accompanying certified manufacturer’s declaration  must be in English.  
 Prior to the product leaving the exporting country, the product must be:  Biological Products  [Document Date ] 
Ministry for Primary Industries  12 – Manufactured using processes which comply with  an industry accepted code of good 
manufacturing practice and using a quality system equivalent to the current version of ISO 9001 
that records details of  
• the product description ; 
• the origin and nature of each batch of product ;  
• the manufacturing process ; 
• the quality control testing carried out ; and  
• packaging and consignment details.  
– derived from cattle born and reared in Australia  and/or New Zealand  (in the case of foetal bovine 
serum, the serum must be obtained from blood collected from foetuses whose dams were born and 
raised in Australia  and/or New Zealand ); and 
• sourced from abattoirs and derived from animals which passed ante -mortem and post -mortem 
inspection and were processed in premises under the supervision of the controlling authority 
and in acc ordance with the regulations of Australia  or New Zealand ; or  
• sourced from donor herds and derived from herds that were under veterinary supervision and 
the animals were clinically free from infectious or contagious diseases.  
 The product must be directed t o an appropriately approved transitional facility and subject ed to testing, 
treatments or procedures required by the Director Animal Health and Welfare , including  
– filtration to 0.22 micron  or less; and  
– irradiation with a single or multiple irradiation dose  totalling 5 mrad (50 kgray).  
 Once the testing, treatments or procedures have been completed in the transitional facility, the product 
may be given biosecurity clearance.  
5.4.1 Recommendation  
(1) Amended to include New Zealand -origin serum. Otherwise, n o change to importation requirements of the 
Import Health Standard for Foetal Bovine Serum, Calf Serum and Bovine Serum for Further Processing 
from Australia BOVSFPIC.AUS .  
 
 Other biological products not cove red by IRA 2005  
6.1 Agricultural Compounds and Veterinary Medicines  
Agricultural compounds are  defined in the A gricultural Compounds and Veterinary Medicines (A CVM ) Act 1997  
and are used in plant or animal management. They include veterinary medicines, agricultural chemicals, oral 
nutritional compounds , fertiliser s, and vertebrate toxic agents.  
Agricultural compounds which contain imported ingredients of biological origin must u ndergo a biosecurity 
assessment as part of the ACVM registration or approval process , unless the imported biological ingredients in 
the product are listed in the Negligible Risk Ingredient Schedule included in the Biosecurity Approval of Imported 
Agricultural Compounds and Veterinary Medicines – ACVM Guidance  document . This assessment is now linked 
with the ACVM applications.  For veterinary medic ine (excluding specified serological products and agricultural 
compounds intended for potency testing in animals ) and vertebrate toxic agent  categories of agricultural 
compounds , the assessment will be managed by the Animal Imports Team . The a gricultural chemical  category  
will be assessed by the Plant Product Imports  Team .  
The risk assessment will use all existing MPI risk analyses , or may include assessment by the MPI Risk Analysis 
Team .  Biological Products  [Document Date ] 
Ministry for Primary Industries  13 Products that do no t require ACVM registration (that is, are exempt from registration under the ACVM Act), and 
contain imported ingredients of biological origin, must meet an existing IHS or be accompanied by an import 
permit.  
6.1.1 Recommendation  
(1) Agricultural compounds (as defined in the ACVM Act)  that contain imported ingredients of biological origin , 
and excluding specified serological products and agricultural compounds intended for potency testing in 
animals , and excluding those that are listed in the Negligible Risk Ing redient Schedule included in the 
Biosecurity Approval of Imported Agricultural Compounds and Veterinary Medicines – ACVM Guidance  
document , that are ACVM Act registered  or approved will be subj ect to an MPI biosecurity risk 
assessment. If the biosecurity risk assessment concludes the risk is effectively managed, the product may  
be imported from any country.  
(2) Specified ACVM products ( such as  plasma for transfusion) that have  testing requirements  for each 
consignment  may be impo rted from any country when the import permit requirements are  met. This may 
include provision of a veterinary certificate.  
(3) Agricultural compounds exempt from ACVM  Act registration which contain  imported ingredients of 
biolog ical origin, excluding those that are listed in the Negligible Risk Ingredient Schedule included in the 
Biosecurity Approval of Imported Agricultural Compounds and Veterinary Medicines – ACVM G uidance  
document, may be imported from any country as long as they meet an existing IHS or are accompanied by 
an import permit.  
(4) Biological ingredients imported as raw materials for formulation into agricultural compounds in New 
Zealand , excluding those that are listed in the Negligible Risk Ingredient Schedule included in the 
Biosecurity Approval of Imported Agricultural Compounds and Veterinary Medicines – ACVM Guidance  
docum ent, will be subject to an MPI risk assessment to determine if they are eligible to be imported . If the 
biosecurity risk assessment concludes the risk is effectively managed , the product  may be imported from 
any country when accompanied by an import permit .  
6.2 Glyoxal as an alternative tissue fixative  
Advice received from the MPI Animal and Aquatic Biosecurity Science & Risk Assessment Team in May 2018  
discusses the use of glyoxal as an alternative tissue fixative.  
Glyoxal has rapid tissue penetration and sho uld be a safe alternative to use as a tissue fixative, especially in 
2mm or less thin sections of tissue. Although not effective in inactivating prions, it was surmised the likelihood of 
animal exposure to fixed thin sections of tissue or microscope slides  is negligible.  
6.2.1 Recommendation  
(1) Specimens of animal tissue no more  than 2mm thick fixed in glyoxal may be imported from any country . 
6.3 Commodities eligible for clearance under another IHS    
Biological p roducts, including samples,  which  are eligible for clearance under another IHS must be cleared under 
that IHS.  
Biological p roducts, including samples, which do not comply with the clearance requirements of another IHS may 
be imported from any country on an import permit if the import perm it requires the product to be held and/or used 
in an appropriately approved transitional facility (as listed on the import permit).  
Biological products that have an unknown health status, or are known to contain or have a risk of harbouring 
unwanted or exo tic organisms are a risk to New Zealand’s biosecurity. Such biological products may not be 
eligible for movement or clearance, subject to a risk assessment of that product and depending on whether or not 
the transitional facility has been approved for that  type of product . Biological Products  [Document Date ] 
Ministry for Primary Industries  14 If the intention is to carry out microorganism enrichment, isolation and / or culture on the products, including 
samples, they must be imported under  the import health standard that relates to microorganisms .