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Non-Proliferation of Weapons of Mass Destruction Act, 1993 (Act No. 87 1993)

Declarations

Declaration of certain Biological Goods and Technologies as Controlled Goods and Control Measures applicable to such Goods

Annexures

Annexure A - Human Pathogens, Zoonoses and Toxins

 

ANNEXURE A

 

 

I. HUMAN PATHOGENS, ZOONOSES AND TOXINS, AS FOLLOWS:

 

a. Viruses, whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material, including living material which has been deliberately inoculated or contaminated with such cultures, as follows:

 

▪ Chikungunya virus;
▪ Eastern equine encephalitis virus;
▪ Western equine encephalitis virus;
▪ Venezuelan equine encephalitis virus;
▪ Oropouche virus;
▪ Rocio virus;
▪ Dengue fever virus;
▪ Yellow fever virus;
▪ Japanese encephalitis virus;
▪ Tick-borne encephalitis complex viruses, including Russian Spring-Summer encephalitis, Kyasanur Forest, Louping ill, Omsk haemorrhagic fever and Powassan;
▪ St Louis encephalitis virus;
▪ Murray Valley encephalitis virus;
▪ Rift Valley fever virus;
▪ Crimean-Congo haemorrhagic fever virus;
▪ Hantaviruses, including Hantaan, Seoul, Dobrava, Puumala and Sin Nombre;
▪ Arenaviruses, associated with haemorrhagic fevers including Lassa fever, Junin, Machupo, Lymphocytic choriomeningitis, Sabia, Flexal, Dandenong, Lujo and Guanarito;
▪ Variola virus;
▪ Monkey pox virus;
▪ Ebola virus;
▪ Marburg virus;
▪ Hendra virus;
▪ Nipah virus.

 

b. Rickettsiae, whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material, including living material which has been deliberately inoculated or contaminated with such cultures, as follows:

 

▪ Coxiella burnetii;
▪ Bartonella quintana (Rochalimaea quintana, Rickettsia quintana);
▪ Rickettsia prowazekii;
▪ Rickettsia rickettsii.

 

c. Bacteria, whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material, including living material which has been deliberately inoculated or contaminated with such cultures, as follows:

 

▪ Bacillus anthracis;
▪ Brucella abortus;
▪ Brucella melitensis;
▪ Brucella suis;
▪ Chlamydia psittaci;
▪ Clostridium botulinum;
▪ Clostridium perfringens, epsilon toxin producing types;
▪ Clostridium tetani;
▪ Enterohaemorrhagic  Escherichia coli, serotype 0157 and other verotoxin producing serotypes;
▪ Francisella  tularensis;
▪ Legionella pneumophila;
▪ Burkholderia mallei (Pseudomonas mallei);
▪ Burkholderia pseudomallei (Pseudomonas pseudomallei);
▪ Salmonella typhi;
▪ Shigella dysenteriae;
▪ Vibrio cholerae;
▪ Yersinia pestis;
▪ Yersinia pseudotuberculosis.

 

d. Toxins, as follows, and subunits of toxins thereof:

 

▪ Abrin;
▪ Botulinum toxins;
▪ Cholera toxin;
▪ Clostridium perfringens toxins;
▪ Conotoxins;
▪ Modeccin;
▪ Ricin;
▪ Saxitoxin;
▪ Shiga toxins;
▪ Staphylococcus aureus toxins;
▪ Tetanus toxin;
▪ Tetrodotoxin;
▪ Trichothecene mycotoxins, such as T-2 toxin, HT-2 toxin and Diacetoxyscirpenol toxin;
▪ Verotoxins;
▪ Microcystin (Cyanginosin);
▪ Aflatoxins;
▪ Volkensin;
▪ Viscum album Lectin 1 (Viscumin);

 

Except:

1. Any goods in the form of a vaccine or toxoid.

A vaccine is a medicinal or veterinary product in a pharmaceutical formulation licensed by, or having marketing or clinical trial authorisation from, the relevant South African regulatory authorities, which is intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered.

 

2. Botulinum toxins and Conotoxins meeting all of the following criteria:
(a) are pharmaceutical formulations designed for testing and human administration in the treatment of medical conditions;
(b) are  pre-packaged  for  distribution  as  clinical  or  medical products; and
(c) are authorised  by the relevant  South African  regulatory authority to be marketed as clinical or medical products

 

e. Fungi, as follows:

 

▪ Coccidioides immitis;
▪ Coccidioides posadasii.

 

II. ANIMAL PATHOGENS, AS FOLLOWS:

 

1. Viruses, whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material, including living material which has been deliberately inoculated or contaminated with such cultures, as follows:

 

▪ African swine fever virus;
▪ African horse sickness virus;
▪ Avian influenza virus, which can be:

 

1. Uncharacterised; or

 

2. Defined as having high pathogenicity, as follows:
i. Type A viruses with an IVPI (intravenous pathogenicity index) in six-week-old chickens of greater than 1.2; or
ii. Type A viruses, H5 or H7 subtype, for which nucleotide sequencing has demonstrated multiple basic amino acids at the cleavage site of haemagglutinin;

 

▪ Bluetongue virus;
▪ Foot-and-mouth disease virus;
▪ Goat pox virus;
▪ Porcine herpesvirus (Aujeszky's disease);
▪ Swine fever virus (Hog cholera virus);
▪ Lyssaviruses;
▪ Newcastle disease virus;
▪ "Peste des petits ruminants" virus;
▪ Porcine enterovirus type 9 (swine vesicular disease virus);
▪ Rinderpest virus;
▪ Sheep pox virus;
▪ Teschen disease virus;
▪ Vesicular stomatitis virus;
▪ Lumpy skin disease.

 

2. Mycoplasma mycoides subspecies mycoides SC (small colony), whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material, including living material which has been deliberately inoculated or contaminated with such Mycoplasma mycoides (mycoides SC).

 

3. Mycoplasma capricolum subspecies capripneumoniae ("strain F38")

 

Except:

 

Any goods in the form of a vaccine or toxoid.

 

III. PLANT PATHOGENS, AS FOLLOWS:

 

a. Bacteria, whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material which has been deliberately inoculated or contaminated with such cultures, as follows:

 

▪ Xanthomonas albilineans;
▪ Xanthomonas campestris pv. citri, including strains referred to as Xanthomonas campestris pv. citri types A, B, C, D, E or otherwise classified as Xanthomonas citri, Xanthomonas campestris pv. aurantifolia, Xanthomonas campestris pv. citrumelo, Xanthomonas axonopodis pv. citri, Xanthomonas axonopodis pv. citrumelo, Xanthomonas axonopodis pv. aurantifolii;
▪ Xanthomonas oryzae pv. oryzae;
▪ Xylella fastidiosa;
▪ Clavibacter michiganensis subspecies sepedonicus (Corynebacterium michiganensis subspecies sepedonicum or Corynebacterium sepedonicum);
▪ Ralstonia solanacearum races 2 and 3 (Pseudomonas solanacearum races 2 and 3 or Burholderia solanacearum races 2 and 3).

 

b. Fungi, whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material which has been deliberately inoculated or contaminated with such cultures, as follows:

 

▪ Colletotrichum kahawae (Colletotrichum coffeanum var. virulans);
▪ Cochliobolus miyabeanus (Helminthosporium oryzae);
▪ Deuterophomonas tracheiphila (syn. Phoma tracheiphila);
▪ Microcyclus ulei (syn. Dothidella ulei);
▪ Monilia rorei (syn. Moniliophthora rorei);
▪ Puccinia graminis (syn. Puccinia graminis f. sp. tritici);
▪ Puccinia striiformis (syn. Puccinia glumarum);
▪ Magnaporthe grisea (Pyricularia grisea/Pyricularia oryzae).

 

c. Viruses, whether natural, synthetic, enhanced or modified, either in the form of isolated live cultures or as material, including living material which has been deliberately inoculated or contaminated with such cultures, as follows:

 

▪ Banana bunchy top virus;
▪ Potato Andean latent tymovirus;
▪ Potato spindle tuber viroid.

 

IV.        GENETICALLY MODIFIED MICRO-ORGANISMS AND GENETIC ELEMENTS, AS FOLLOWS:

 

a. Genetically modified micro-organisms or genetic elements that contain nucleic acid sequences associated with pathogenicity, or may lead to pathogenicity of non-pathogenic sequences in organisms specified in (I.a) to (I.c) or (II) or (III).

 

b. Genetically modified micro-organisms or genetic elements that contain nucleic acid sequences coding for any of the toxins specified in (I.d) or subunits of toxins thereof.