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     2.  - (1) Where any of the conditions or group of conditions set out in paragraphs (2) to (5) is satisfied, something which would otherwise fall within section 58(4)(a) of the Act is not to be regarded as a dangerous substance.

    (2) In the case of a pathogen or toxin, those conditions are:

(a) that it exists in the form of, or is included in, a medicinal product; or

(b) that it is an immunological product intended to diagnose whether a state of immunity to certain diseases exists in human beings or animals.

    (3) In the case of a pathogen, those conditions are:

(a) that it is modified for use to be administered to one or more human beings or animals for a medicinal purpose; or

(b) that it is kept in such a way that it is no longer in a state that will allow it to be propagated; or

(c) that it is kept - 


(i) as part of a clinical specimen for diagnostic purposes, and

(ii) for no longer than is reasonably practicable for its disposal after the time when the diagnosis has been made.

    (4) In the case of a toxin which is neither a botulinum toxin nor a clostridium perfringens toxin (other than clostridium perfringens alphatoxin), those conditions are:

(a) that, in the case of premises which are not divided into secure parts, the amount of the toxin in question kept at any particular premises does not exceed 5 milligrams (whether or not the amount of that toxin taken together with any other toxin at those premises exceeds that amount); or

(b) that the amount of the toxin in question kept at any particular secure part of any premises does not exceed 5 milligrams (whether or not the amount of that toxin taken together with either - 


(i) any other toxin kept at the same secure part, or

(ii) the same or any other toxin kept at another secure part of the premises in question,



exceeds that amount).

    (5) In the case of any toxin, those conditions are:

(a) that it exists only as an immunotoxin; or

(b) that it has not been deliberately isolated or extracted from its natural source.

    (6) In this regulation:

"administer" has the same meaning as in section 130(9) of the Medicines Act 1968[2];

"immunotoxin" means a conjugate of one cell specific monoclonal antibody and a toxin or subunit of a toxin, that selectively affects diseased cells;

"medicinal product" means any substance or article which is held in a form which is ready to be administered to one or more human beings or animals for a medicinal purpose;

"medicinal purpose" has the same meaning as in section 130(2) of the Medicines Act 1968; and

"secure part", in relation to premises, means a part of the premises which is securely divided from any other part of the premises at which a toxin is kept.

     3.  - (1) Where the condition set out in paragraph (2) is satisfied, a pathogen which would otherwise fall within section 58(4)(b) of the Act is not to be regarded as a dangerous substance.

    (2) Subject to paragraph (3), that condition is that the substance for the time being mentioned in Schedule 5 to the Act infects or is otherwise carried by:

(a) any animal, alive or dead, or anything which is or was a part of it;

(b) any human corpse, or any part of it;

(c) any food or food source within the meaning of the Food Safety Act 1990[3]; or

(d) any feeding stuff.

    (3) Paragraph (2) does not apply if the occupier of the premises where any of the things set out in sub-paragraphs (a) to (d) of that paragraph is kept:

(a) knows or ought reasonably to have known that the thing in question had been deliberately infected by a pathogen or that it otherwise carries a pathogen as a result of a deliberate act, and

(b) keeps the thing in question for longer than is reasonably necessary for its disposal.

    (4) In paragraph (2)(d) "feeding stuff" means - 

(a) a product of vegetable or animal origin in its natural state (whether fresh or preserved);

(b) a product derived from the industrial processing of such a product; or

(c) an organic or inorganic substance, used simply or in a mixture,

whether or not containing additives, for oral feeding to animals.


John Denham
Minister of State

Home Office
4th May 2002

[2] 1968 c.67; section 130(9) was amended by paragraph 3(10) of Schedule 1 to the Animal Health and Welfare Act 1984 (c.40).back

[3] 1990 c.16; "food" and "food source" are defined by section 1 of that Act.back

  Prepared 14 May 2002