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The Transmissible Spongiform Encephalopathies (England) Regulations 2010
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Approval of laboratories
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10.—(1) The Secretary of State must approve laboratories to test samples taken under paragraph 8 if the Secretary of State is satisfied that the laboratory—
(a)will carry out the testing in accordance with Chapter C of Annex X to the EU TSE Regulation;
(b)has adequate quality control procedures; and
(c)has adequate procedures to ensure the correct identification of the samples and notification of the test results to the consigning slaughterhouse and to the Secretary of State.
(2) The Secretary of State may charge the fees set out in the following table for the initial approval and ongoing quality assessment of a laboratory—
Fees
| Laboratory approvals and quality assessments | Fee (£) |
|---|---|
| Initial approval | 29,770 |
| Annual proficiency testing and follow-up inspection for the first year after approval | 8,834 |
| Annual proficiency testing from the second year after approval | 4,135 |
| Single proficiency test (in the event of a failure in the annual proficiency testing) | 1,385 |
| Hourly rate of an inspector (for any additional inspections that are necessary to check for compliance with the matters set out at sub-paragraphs (1)(a) to (c)) | 87.24 |
(3) For the purposes of this paragraph and paragraphs 8 and 9, an “approved testing laboratory” means—
(a)a laboratory approved under this paragraph;
(b)a laboratory approved under corresponding legislation elsewhere in the United Kingdom;
(c)an EU National Reference Laboratory; or
(d)a diagnostic laboratory approved by a member State in accordance with Annex X to the EU TSE Regulation.
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