Commission Decision 2006/437/EC approving a Diagnostic Manual for avian influenza
10.—(1) Commission Decision 2006/437/EC approving a Diagnostic Manual for avian influenza is amended as follows.
(2) In Article 2, for “Member States” substitute “The appropriate Minister”.
(3) After Article 2, insert—
“Article 2a
For the purposes of this Decision—
(a)“the appropriate Minister” means—
(i)in relation to England, the Secretary of State;
(ii)in relation to Northern Ireland, the Department of Agriculture, Environment and Rural Affairs;
(iii)in relation to Scotland, the Scottish Ministers;
(iv)in relation to Wales, the Welsh Ministers.
(b)“the competent authority” means the appropriate Minister for the relevant constituent part of the United Kingdom.”.
(4) Omit Article 3.
(5) The Annex is amended in accordance with paragraphs (6) to (11).
(6) In Chapter 1 (introduction, objectives and definitions)—
(a)in paragraph 1, in the words before point (a), for “Community” substitute “United Kingdom”;
(b)in paragraph 6(b)—
(i)in point (i), omit the words from “organised” to “laboratory)”;
(ii)in point (ii)—
(aa)omit “by the Community Reference Laboratory”;
(bb)omit the words from “the results” to the end.
(7) In Chapter 5 (diagnostic virological tests and evaluation of results), in paragraph 4—
(a)in subparagraph (b)—
(i)for point (iii) substitute—
“(iii)immediately undertake confirmation and full characterisation of all HPAI, H5 and H7 isolates.”;
(ii)in the words following subparagraph (iv), omit the second sentence;
(b)omit subparagraphs (c) and (d).
(8) In Chapter 6 (molecular tests and evaluation of results), for the words after the first unnumbered paragraph, substitute—
“The Weybridge National Reference Laboratory has produced protocols for molecular tests including conventional RT-PCR and rRT-PCR to be followed as standard. If test parameters, such as cycling and ramp times, are varied from those recommended in the specified protocols they must be demonstrated to be consistent with paragraph 6 of Chapter I of this diagnostic manual prior to use. ”.
(9) In Chapter 8 (serological tests and evaluation of results), for the fifth unnumbered paragraph (and the website reference below it) substitute—
(10) “The Weybridge National Reference Laboratory standard protocols for serological tests and evaluation of their results must be followed”.
(11) For Chapter 13 substitute—
“CHAPTER 13Dispatch of viruses and samples to the Weybridge laboratory
Any samples to be sent to the Weybridge National Reference Laboratory must comply with legislative requirements for the transport of dangerous pathogens.
The outer packaging must indicate whether it contains avian influenza virus or tissues and other materials for testing, and be marked as follows:
‘ANIMAL PATHOGEN — PACKAGE ONLY TO BE OPENED AT THE AVIAN VIROLOGY SECTION, WEYBRIDGE LABORATORY, NEW HAW, SURREY, TK15 3NB’”;
(12) In Chapter 14—
(a)in paragraph 1, in the second unnumbered subparagraph, for “In the Community” substitute “The”;
(b)in paragraph 5—
(i)in the first subparagraph, for “in Member States” substitute “that report to the appropriate Minister”,
(ii)in the second subparagraph, for “of the Member States” substitute “that report to the appropriate Minister”,
(iii)in the third subparagraph, for the words “Community” to “
(iv)United Kingdom,” substitute “National reference laboratory are the national rules that”.