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The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Regulations 2021

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There are currently no known outstanding effects for the The Health Protection (Coronavirus) (International Travel and Operator Liability) (Scotland) Regulations 2021, PART 4. Help about Changes to Legislation

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PART 4STesting following arrival in Scotland

Part 4: application and interpretationS

11.—[F1(1) Subject to F2... regulation 18 (persons not required to comply), this Part applies to a person (“P”) who is an arrival.]

[F3(1A) Regulations 15 and 16 apply to a person (“P”) who is—

(a)a red list arrival, or

(b)an arrival who is not an eligible vaccinated arrival.]

F4(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) For the purposes of this Part—

“day 2 test” means a test which complies with regulation 14(9) and is undertaken in accordance with regulation 14(2),

“day 8 test” means a test provided in a testing package with a day 2 test which complies with regulation 14(9) and is undertaken in accordance with regulation 14(4),

“testing package” means—

(a)

in the case of a red list arrival or an F5... arrival who is not an eligible vaccinated arrival, a booking for a day 2 test and a day 8 test,

(b)

in the case of F6... an eligible vaccinated arrival, a booking for a day 2 test,

“test provider” means a provider who provides a test in accordance with regulation 14(9).

(4) In regulations 15 and 16, references to sharing designated accommodation means sharing the place where such persons are staying (as defined by regulation 21(3) and (4)).

Textual Amendments

Commencement Information

I1Reg. 11 in force at 20.9.2021, see reg. 1(2)

Requirement to possess testing packageS

12.—(1) Where P is an adult, P must, on arrival in Scotland, possess a testing package—

(a)for P, and

(b)for any child aged 11 or over with whom P is travelling and for whom P has responsibility.

(2) Where P is an adult who arrives in Scotland without possessing a testing package in accordance with paragraph (1), P must obtain a testing package as soon as practicable on arrival.

(3) Where P is a child aged 11 or over and who is unaccompanied by an adult who has responsibility for P, a person with responsibility for P must obtain a testing package for P as soon as is practicable after P arrives in Scotland.

(4) A person who possesses a testing package must provide evidence of it if requested to do so by an immigration officer.

(5) Where P is required to comply with Part 5 (managed isolation), P is deemed to have complied with this regulation where P purchases a testing package as part of a managed isolation package in accordance with that Part.

Commencement Information

I2Reg. 12 in force at 20.9.2021, see reg. 1(2)

Requirement to provide informationS

13.—(1) Subject to paragraph (2), at the time the testing package is booked, P must notify the test provider that P is required to undertake the test or tests to which the testing package relates under these Regulations, and provide the test provider with—

(a)P's full name,

(b)P's sex,

(c)P's date of birth,

(d)P's NHS number (if known and applicable),

(e)P's ethnicity,

(f)the date of P's arrival in the United Kingdom,

(g)P's coach number, flight number or vessel name (as appropriate),

(h)the date on which P last departed from or transited through—

(i)a red list country, [F7or]

[F8(ii)failing which another country, territory or part of a country or territory which is not in the common travel area,]

(i)the country or territory P was travelling from when P arrived in the United Kingdom, and any country or territory P transited through as part of that journey,

(j)P's email address,

(k)P's telephone number,

(l)P's passport number or travel document reference number (as appropriate), and

(m)P's home address, and, where relevant, the address or addresses of the specified premises where P intends to stay in accordance with Part 6 (self-isolation).

(2) Where P is a child, or a person with a disability who is unable for that reason to provide the notification and information set out or referred to in paragraph (1) to the test provider—

(a)the notification and information set out or referred to in paragraph (1), other than the information set out in paragraph (1)(j) and (k), must be provided to the test provider on P's behalf by another person (“X”), and

(b)either the information set out in paragraph (1)(j) and (k) must be provided by X to the test provider or, where appropriate, X must provide their own telephone number and email address to the test provider.

(3) At the time the testing package is booked, the test provider must give a test reference number to P and, where appropriate, also give that test reference number to X.

(4) For the purposes of paragraphs (2) and (3), where P is a child, “X” means a person who has responsibility for P.

Textual Amendments

Commencement Information

I3Reg. 13 in force at 20.9.2021, see reg. 1(2)

Requirement to undertake testsS

14.—(1) P must undertake the test or tests in their testing package in accordance with this regulation.

[F9(1A) If a test is to be self-administered, P must undertake a test in accordance with the manufacturer’s instructions for use.]

(2) P must undertake the day 2 test no later than the end of the 2nd day after the day on which P arrived in Scotland.

(3) Where P's day 2 test generates a positive result and P would otherwise be required to take the day 8 test, P is not required to undertake the day 8 test.

(4) Where P is required to undertake the day 8 test, P must undertake that test no earlier than the end of the 7th day after the day on which P arrived in Scotland.

(5) Where P is a child aged 11 or over, any person who has responsibility for P must, so far as reasonably practicable ensure that P undertakes a day 2 test and, where relevant, a day 8 test.

(6) Where P does not undertake either a day 2 test or a day 8 test by reason of a reasonable excuse (see regulation 30), P must, as soon as practicable after the matters giving rise to the reasonable excuse no longer apply, undertake a replacement test complying with the requirements of paragraph (9).

(7) Where a replacement test is undertaken instead of—

(a)a day 2 test, P is to be treated as if P had undertaken a day 2 test in accordance with this regulation,

(b)a day 8 test, P is to be treated as if P had undertaken a day 8 test in accordance with this regulation.

(8) Where a test is undertaken by P after this regulation applies, and that test meets the requirements of paragraph (9) and generates a positive result, P is not required to undertake a subsequent day 2 test or day 8 test, as the case may be.

(9) The requirements of this regulation are that—

(a)the test is provided by a public provider, or where P is [F10not a red] list arrival, a public provider or a private provider, and

[F11(b)the test is—

(i)where P is a red list arrival or not an eligible vaccinated arrival, a test which complies with paragraph (9A), or

(ii)where P is an eligible vaccinated arrival, a test which complies with paragraph (9B).]

[F12(9A) For the purposes of [F13paragraph (9)(b)(i)], a test complies with this paragraph if—

(a)it is a semi-quantitative test for the detection of coronavirus which—

(i)targets a minimum of two distinguishable SARS-CoV-2 genes other than the S gene and performance reference controls,

(ii)includes routine in silico assurance against every variant of concern, and

(iii)produces a test solution that provides extracted nucleic acid that is suitable for whole genome sequencing using a specified method,

(b)it is, in relation to a red list arrival, a test that can be self-administered,

(c)the manufacturer of any device used for the purposes of the test states that the device—

(i)uses an established molecular detection method,

(ii)in relation to a day 2 test, has a specificity and a sensitivity greater than or equal to 99% (or a 95% two-sided confidence interval entirely above 97%),

(iii)in relation to a day 8 test, has a specificity greater than or equal to 97% (or a 95% two-sided confidence interval entirely above 95%),

(iv)in relation to a day 8 test, has a sensitivity greater than or equal to 95% (or a 95% two-sided confidence interval entirely above 90%),

(v)has a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, and

(vi)is suitable for identifying every variant of concern, and

(d)any device used for the purposes of the test—

(i)can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002, other than solely by virtue of regulation 39(2) of those Regulations, and

(ii)has been validated no more than 18 months before the test is administered or provided to P.]

[F14(9B) For the purposes of paragraph (9)(b)(ii), a test complies with this paragraph if—

(a)it is a test for the detection of coronavirus which uses one or more of—

(i)mid-turbinate or anterior nares nasal swabbing,

(ii)tonsillar swabbing,

(iii)saliva,

(b)the test is uniquely identifiable,

(c)the test is provided in accordance with the test manufacturer’s instructions for use including, in particular, instructions as to the target use, target user and target use settings, and

(d)any device used for the purposes of the test can be put into service in accordance with Part 4 of the Medical Devices Regulations 2002, other than solely by virtue of regulation 39(2) of those Regulations.]

(10) In this regulation, “public provider” means a test provider who provides or administers a test under—

(a)the National Health Service (Scotland) Act 1978,

(b)the National Health Service Act 2006,

(c)the National Health Service (Wales) Act 2006, or

(d)the Health and Personal Social Services (Northern Ireland) Order 1972.

(11) In this regulation “private provider” means a day 2 test and a day 8 test provider, other than a public provider, who—

(a)has made a self-declaration to the Department of Health and Social Care that the provider meets the minimum standards that private sector providers must meet for coronavirus tests for persons arriving in England in terms of schedule 8 to the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 M1 and DHSC guidance, and

(b)is currently on the UK Government published list of private day 2 test and day 8 test providers for persons arriving in England M2.

[F15(12) For the purposes of paragraph (9A)—

(a)“specified method” means a targeted sequence method specific to SARS-CoV-2 or an equivalent—

(i)amplicon method, or

(ii)sequence bait capture method,

(b)“validated”, in relation to a device, means confirmed as having the required sensitivity and specificity using at least 150 positive clinical samples and 250 negative clinical samples against a laboratory-based RT-PCR test that is itself within the performance specification of the target product profile published by the Medicines and Healthcare Products Regulatory Agency for laboratory based SARS-CoV-2 PCR tests, by—

(i)the Secretary of State, or

(ii)a laboratory which is accredited to ISO standard 15189 or ISO/IEC standard 17025F16 by—

(aa)the United Kingdom Accreditation ServiceF17, or

(bb)an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (“ILAC”) Mutual Recognition ArrangementF18 or the European co-operation for Accreditation (“EA”) Multilateral AgreementF19,

other than a laboratory which processes tests provided by the test provider for the purposes of this Part or which is owned by the test provider or the device manufacturerF20,

(c)“variant of concern” means a variant of SARS-CoV-2 identified in a designation published by the UK Health Security Agency for the purposes of this paragraphF21.]

Textual Amendments

F16ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. ISO 15189 Medical Laboratories requirements for quality and competence was published in November 2012. ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories was published in November 2017.

F17The United Kingdom Accreditation Service is a company limited by guarantee incorporated in England and Wales under number 3076190.

F18ILAC is an international organisation which coordinates the work of its signatory national accreditation bodies which are themselves involved in the accreditation of conformity assessment bodies, testing laboratories, and medical testing laboratories.

F19EA is a regional organisation which coordinates the work of its signatory national accreditation bodies. EA is recognised by and works closely with ILAC.

F20A body corporate established under section 232 of the Health and Social Care Act 2012 (c. 7).

F21Technical briefing documents on novel SARS-CoV-2 variants are published by the UK Health Security Agency and are available online at https://www.gov.uk/government/publications/investigation-of-sars-cov-2-variants-technical-briefings.

Commencement Information

I4Reg. 14 in force at 20.9.2021, see reg. 1(2)

Marginal Citations

M1S.I. 2021/582. Relevant amending instruments to schedule 8 are S.I. 2021/682, S.I. 2021/865 and S.I. 2021/914.

M2The list can be accessed through this web-site: https://www.gov.uk/find-travel-test-provider.

Requirement to self-isolate on failure to undertake a testS

15.—(1) Paragraphs (2) to (4) apply where—

(a)either—

(i)P fails to undertake a day 2 test, or

(ii)P's day 2 test generates a negative or inconclusive result, and

(b)P fails to undertake a [F22required] day 8 test.

(2) Where P is required to comply with Part 5 (managed isolation), P must remain in the accommodation designated as part of P's managed isolation package in accordance with regulation 21 until the end of the 14th day after the day on which P arrived in Scotland.

(3) Where P is required to comply with Part 6 (self-isolation), P must remain in the specified premises in accordance with regulation 26 until the end of the 14th day after the day on which P arrived in Scotland.

(4) Where P is a child, any person who is sharing designated accommodation or specified premises with P must remain in such accommodation or premises until the expiry of the period mentioned in paragraph (2) or (3) (as the case may be).

Textual Amendments

Commencement Information

I5Reg. 15 in force at 20.9.2021, see reg. 1(2)

Consequences of test resultsS

16.—(1) Where a test undertaken by a person (“P”) in accordance with regulation 14(2) or (4) generates a positive result—

(a)P no longer has a defence under—

(i)regulation 31(3)(a), where P is required to comply with Part 5, or

(ii)regulation 32(2)(a), where P is required to comply with Part 6, and

(b)P and, subject to paragraph (2), any person who is sharing designated accommodation or specified premises with P (“B”), must remain in that accommodation or premises in accordance with regulation 21 or 26 (as the case may be) until the end of the 10th day after the day P undertook the test.

(2) Paragraph (1)(b) does not apply to B where—

(a)the test referred to in paragraph (1) is P's day 8 test, and

(b)B undertook a day 2 test that generated a positive result.

(3) Where an earlier test undertaken by P after this regulation applies meets the requirements of regulation 14(9) and generates a positive result, the requirement for P to remain in such premises or accommodation under paragraph (1)(b) only applies until the end of the 10th day after the day P undertook that earlier test.

(4) Where an earlier test undertaken by B after this regulation applies meets the requirements of regulation 14(9) and generates a positive result, the requirement for B to remain in such premises or accommodation under paragraph (1)(b) only applies until the end of the 10th day after the day B undertook that earlier test.

(5) Where P's day 2 test and P's day 8 test both generate a negative result, P must remain in the designated accommodation or specified premises until—

(a)the later of—

(i)the date specified in regulation 21(1), where P is required to comply with Part 5, or

(ii)the date specified in regulation 26(2), where P is required to comply with Part 6, or

(b)the day on which P receives the result of P's day 8 test.

(6) Subject to regulation 15, where a test undertaken by P generates an inconclusive result, P must remain in the designated accommodation or specified premises until—

(a)the end of the 10th day after the day P undertook the test,

(b)where P undertakes a test to which paragraph (8) applies and the test generates a negative result, the later of—

(i)the end of the period of 10 days beginning with the day after the day of P's arrival in Scotland, or

(ii)the day on which P receives the negative result, or

(c)where P undertakes a test to which paragraph (8) applies and the test generates a positive result, until the end of the 10th day after the day P undertook the test.

(7) Where paragraph (6)(c) applies, P is not required to undertake a day 8 test.

(8) This paragraph applies to—

(a)a day 8 test, and

(b)a replacement test—

(i)complying with the requirements for a day 8 test other than the requirement that the test be administered or provided to P no earlier than the beginning of the 7th day after the day on which P arrived in Scotland,

(ii)undertaken in the circumstances specified in regulation 14, and

(iii)undertaken during the period referred to in paragraph (6)(a).

Commencement Information

I6Reg. 16 in force at 20.9.2021, see reg. 1(2)

[F23Eligible vaccinated arrivals: notification of result of self-administered testS

16A.—(1) This regulation applies where P—

(a)is an eligible vaccinated arrival,

(b)undertakes a day 2 test but it is not a test that complies with regulation 14(9A), and

(c)the test is not administered—

(i)by the test provider, or

(ii)at a site operated for the purposes of administering such tests by a test provider.

(2) Subject to paragraph (3), P must provide the test provider with the information set out in paragraph (5) within 15 minutes of the test’s read time as determined by the manufacturer’s instructions for use.

(3) If P is—

(a)a child, or

(b)a person with a disability who is unable for that reason to provide the information to the test provider,

regulation 13(2) and (4) applies instead of paragraph (2).

(4) For the purposes of paragraph (3)—

(a)regulation 13(2) is to be read as if it referred to the information set out in paragraph (5),

(b)regulation 13(2)(b) is to be disregarded.

(5) The information is—

(a)a single photograph clearly showing—

(i)the test device in such a way that it is identifiable as having been provided by the test provider,

(ii)the test reference number provided pursuant to regulation 13(3), and

(iii)the test result, and

(b)the address at which P is able to receive a confirmatory test pursuant to regulation 16B.

Textual Amendments

Eligible vaccinated arrivals: confirmatory testS

16B.—(1) This regulation applies where P—

(a)is an eligible vaccinated arrival,

(b)undertakes a day 2 test but it is not a test that complies with regulation 14(9A), and

(c)receives notification that the test has generated a positive result.

(2) P must as soon as reasonably practicable undertake a confirmatory test provided by a public provider. In this regulation “public provider” has the same meaning as in regulation 14(10).

(3) For the purposes of paragraph (1)(c), a person who self-administers a test is deemed to receive notification of a result in relation to the test when the person determines the result in accordance with the test manufacturer’s instructions for use.]

Textual Amendments

Charge for testing packageS

17.—(1) The Scottish Ministers, or a person designated by the Scottish Ministers, may impose a charge in respect of a testing package provided by a test provider in accordance with regulation 14(9).

(2) The Scottish Ministers—

(a)must publish details of the charges in such manner as they consider appropriate, and

(b)may recover any sum owed by a person pursuant to such a charge as a debt.

Commencement Information

I7Reg. 17 in force at 20.9.2021, see reg. 1(2)

Part 4: persons not required to complyS

18.—(1) [F24A] person (“P”) is not required to comply with this Part where P is—

(a)a child (without prejudice to regulations 12(1)(b) and (3), 13(2), 15 and 16),

(b)a person who—

(i)has arrived from England, and

(ii)is in Scotland, temporarily, for a reason mentioned in regulation 32(2)(a) to (j),

(c)a person who has arrived in Scotland from elsewhere within the common travel area in order to travel immediately onwards to—

(i)another part of the United Kingdom, or

(ii)elsewhere outside of the United Kingdom,

[F25(d)a person who, on arrival in the United Kingdom—

(i)passes through to another country or territory outside the common travel area without entering the United Kingdom, or

(ii)enters the United Kingdom for the sole purpose of continuing a journey to a country or territory outside the common travel area and—

(aa)remains within their port of entry until their departure from Scotland, or

(bb)travels directly from their port of entry to another port of departure in Scotland,]

[F26(da)a person who—

(i)arrives in Scotland on a cruise ship, and

(ii)is due to depart from Scotland on the same cruise ship within 48 hours of their arrival,]

(e)a person described in paragraph 1(1)(a) to (h) or (k) of schedule 4 or a member of the family forming part of their household,

(f)a person described in paragraph 1(1)(i) or (j) of schedule 4 where the conditions in paragraph (2) are met,

(g)a member of the family forming part of the household of a person referred to in sub-paragraph (f) where the Foreign, Commonwealth and Development Office—

(i)has been notified of P's arrival, and

(ii)has confirmed that P is not required to comply with this Part,

(h)a specified person travelling to the United Kingdom to conduct official business with the United Kingdom, where—

(i)P was invited to the United Kingdom by the Secretary of State for Foreign, Commonwealth and Development Affairs, and

(ii)Prior to P's departure to the United Kingdom, the Foreign, Commonwealth and Development Office has confirmed in writing to P that they are travelling to the United Kingdom to conduct official business with the United Kingdom and are not required to comply with this Part,

(i)a member of the family forming part of the household of a person to whom sub-paragraph (h) applies, where—

(i)the Foreign, Commonwealth and Development Office has been notified of P's arrival, and

(ii)the Foreign, Commonwealth and Development Office has confirmed that P is not required to comply with this Part,

(j)a person described in any of the following provisions of schedule 4—

F27(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)paragraphs 2 to 6 (except for [F28paragraphs 4A and 5(1)(c)]) (Crown servants, government contractors etc.),

(iii)paragraphs 8 to 15 (except for paragraph 11) (transportation),

(iv)paragraphs 17 to 19 (extradition),

(v)paragraph 28 (oil workers),

(vi)paragraph 34 (telecommunications),

(vii)paragraphs 35 or 36 (healthcare and human tissue carriers), or

(viii)paragraph 42 (elite sportspersons).

(2) The conditions referred to in paragraph (1)(f) are that, prior to P's departure to the United Kingdom—

(a)the relevant head of the mission, consular post, or office representing a foreign territory in the United Kingdom, or a Governor of a British overseas territory (as the case may be), or a person acting on their authority, confirms in writing to the Foreign, Commonwealth and Development Office that P is required to undertake work in the United Kingdom which is essential to the foreign territory represented by the mission or consular post, the foreign territory represented by the mission or consular post, the foreign territory represented by the office or the British overseas territory, and

(b)the Foreign Commonwealth and Development office has then confirmed in writing to the person giving the confirmation referred to in sub-paragraph (a) that—

(i)it has received that confirmation, and

(ii)P is travelling to the United Kingdom to conduct official business with the United Kingdom and is not required to comply with this Part.

F29(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) A word or expression used in this regulation has the same meaning as it has in schedule 4.

Textual Amendments

Commencement Information

I8Reg. 18 in force at 20.9.2021, see reg. 1(2)

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