Public Health, England Citation, commencement, extent and application 1 1 These Regulations may be cited as the Health Protection (Coronavirus, International Travel and Operator Liability) (England) (Amendment) (No. 9) Regulations 2021. 2 Save as is provided in paragraphs (3) to (5), these Regulations come into force at 4.00 a.m. on 30th August 2021. 3 The following regulations come into force at 4.00 a.m. on 28th August 2021— a this regulation; b regulation 8(1) and (3); c regulation 19. 4 The following regulations come into force on 21st September 2021— a regulation 7; b regulation 8(4); c regulation 9; d regulation 10; e regulation 16(3)(a) and (b); f regulation 17(3)(a); g regulation 20(4) and (5) ...; h regulation 21. 5 Regulation 18(3) comes into force on 1st October 2021. 6 These Regulations extend to England and Wales, and apply in relation to England only. Amendments to the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 2 The Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 are amended in accordance with regulations 3 to 20. Amendment of regulation 2 3 1 Regulation 2 (interpretation) is amended as follows. 2 In paragraph (1)— a after the definition of the “common travel area”, insert— “ the Conference of the Parties ” means, except in relation to the Kyoto Protocol and the Paris Agreement, the Conference of the Parties to the United Nations Framework Convention on Climate Change; “ the COP ” means the conference convened by the Conference of the Parties, comprising— a the 26th session of the Conference of the Parties, b the 16th session of the Conference of the Parties serving as the meeting of the Parties to the Kyoto Protocol, c the third session of the Conference of the Parties serving as the meeting of the Parties to the Paris Agreement, and d all related pre-sessional meetings, sessions of subsidiary bodies and additional meetings, convened in the United Kingdom; “ the COP World Leaders summit event ” means— a the event organised by Her Majesty's Government between 1st and 2nd November 2021 in connection with the COP, or b a meeting, connected to the event described in sub-paragraph (a), between representatives of States, foreign territories or organisations which are represented at the event; ; b after the definition of “immigration officer”, insert— “ the Kyoto Protocol ” means the Protocol to the United Nations Framework Convention on Climate Change signed in Kyoto on 11th December 1997 ; ; c after the definition of “operator”, insert— “ the Paris Agreement ” means the agreement adopted at the 21st Conference of the Parties of the United Nations Framework Convention on Climate Change, signed in Paris on 12th December 2015 ; ; d after the definition of “tunnel system”, insert— “ United Nations Framework Convention on Climate Change ” means the United Nations Framework Convention on Climate Change adopted in New York on 9th May 1992 . Amendment of regulation 3 4 1 Regulation 3 (requirement on passengers to provide information) is amended as follows. 2 In paragraph (10), in the opening words, for “paragraph (11)” substitute “ paragraphs (11) and (12) ” ; 3 After paragraph (11), insert— 12 Notwithstanding paragraph (10), a person (“P”) is required to comply with this regulation if— a P is a person described in paragraph 1(2) of Schedule 4, where the relevant international event referred to in that paragraph is the COP, and b P is not— i a person invited by Her Majesty's Government to attend both the COP World Leaders summit event and the COP, or ii a person described in Schedule 4A. . Amendment of regulation 5 5 1 Regulation 5 (requirements relating to tests) is amended as follows. 2 In paragraph (1)— a in sub-paragraph (d) omit “or in paragraph 44A (Euro 2020 invitees)” . b in sub-paragraph (e)— i in the opening words, for “or (15)(ib)” substitute “ , (15)(ib) or (15)(ic) ” ; ii move the terminal “or” from after paragraph (xx) to after paragraph (xxi); iii at the end insert— xxii paragraph 49 (London Fashion Week invitees) . 3 In paragraph (6)— a in sub-paragraph (d), insert at the beginning, “ subject to paragraph (7A), ” ; b omit sub-paragraph (g) . 4 After paragraph (7), insert— 7A Notwithstanding paragraph (6)(d), regulation 6 applies to a person who— a is a person described in paragraph 1(2) of Schedule 4, where the relevant international event referred to in that paragraph is the COP, and b is not— i a person invited by Her Majesty's Government to attend both the COP World Leaders summit event and the COP, or ii a person described in Schedule 4A. . Amendment of regulation 9 6 1 Regulation 9 (further requirements on arrivals from category 2 countries and territories) is amended as follows. 2 In paragraph (15)— a omit sub-paragraphs (ea) and (eb) ; b after sub-paragraph (ib) insert— ic in paragraph 49(1) of Schedule 4, P satisfies the requirements of paragraph (2) if P complies with the conditions specified in paragraph 49(3) of that Schedule; . Insertion of Part 4A 7 After Part 4 (requirements on operators) insert— PART 4A Requirements on private test providers and diagnostic laboratories Requirements on test providers 18A 1 A private provider who provides a test for the purposes of regulation 6 (requirement to book and undertake tests) must comply with the requirements set out in the following provisions of Schedule 8 (mandatory testing after arrival in England)— a where the test to be provided is a day 2 test, paragraphs (a) to (m) of paragraph 7(1) (day 2 tests: private provider requirements); b where the test to be provided is a day 8 test, paragraphs (a) to (m) of paragraph 9(1) (day 8 tests: private provider requirements); c in any event— i paragraph 10(5) (requirement for private provider to give test reference number); ii paragraph 11(2) (notification of test results). 2 A test provider who provides a test for the purposes of regulation 9(16) (optional testing to cease self-isolation requirement early) must comply with the requirements set out in the following provisions of Schedule 10 (optional testing after arrival in England)— a paragraphs (a) to (j) of paragraph 3(1) (test providers); b paragraph 5(2) and (4) (notification of test results). 3 In this regulation, “ private provider ” has the meaning given in paragraph 1(e) of Schedule 8. Requirements on other persons carrying out testing services 18B 1 A person who carries out an element of a single end-to-end testing service on behalf of a test provider must comply with the requirements set out in the following provisions so far as relevant to the carrying out of that element— a in relation to a day 2 test provided for the purposes of regulation 6, paragraph 7(1)(m)(i) to (iii) of Schedule 8; b in relation to a day 8 test provided for the purposes of regulation 6, paragraph 9(1)(m)(i) to (iii) of Schedule 8; c in relation to a test provided for the purposes of regulation 9(16), paragraphs 3(1)(c) to (i) of Schedule 10. 2 In this regulation, “ single end-to-end testing service ” has the meaning given by paragraph 3(2)(c) of Schedule 10. . Amendment of regulation 19 8 1 Regulation 19 (offences and penalties) is amended as follows. 2 After paragraph (1)(i) insert— ia without reasonable excuse P contravenes a requirement in paragraph 16(aa) of Schedule 11 (requirement for responsible adult to quarantine with child); . 3 In paragraph (2) for sub-paragraph (c) substitute— c Schedule 11— i in paragraph 3, if P enters England at a place other than a designated port in the circumstances specified in regulation 18(2), or ii in paragraphs 5 to 7 or 10, if accommodation or transport booked is no longer available for reasons beyond the P's control. . 4 After paragraph (13A) insert— 13B A person who, without reasonable excuse, contravenes a requirement in— a regulation 18A(1) or (2) (requirements on test providers); or b regulation 18B(1) (requirements on other persons carrying out testing services), commits an offence. . Amendment of regulation 20 9 In paragraph (9) of regulation 20 (fixed penalty notices)— a in the opening words of sub-paragraph (a), after “operator offence” insert “ or a test provision offence ” ; b after sub-paragraph (b), insert— ba in relation to a test provision offence, “ authorised person ” means the local authority in whose area the offence is alleged to have been committed and for the purposes of this sub-paragraph— i the reference to “ local authority ” includes a reference to a county council; ii a county council for an area for which there is also a district council is to be regarded, with respect to its functions under this regulation, as a relevant health protection authority for the purposes of the Public Health (Control of Disease) Act 1984; ; c in sub-paragraph (c)— i in paragraph (i), after “operator offence” insert “ or a test provision offence ” ; ii in paragraph (ii), after “operator offence” insert “ or a test provision offence ” ; d in sub-paragraph (d), at the end insert— ; e “ test provision offence ” means an offence— i under regulation 19(13B), or ii under regulation 19(14) in relation to a function relating to an offence under regulation 19(13B) . Amendment of regulation 21 10 In regulation 21 (prosecutions)— a in paragraph (1), after “operator offence” insert “ or a test provision offence ” ; b in paragraph (2), after “operator offence” insert “ or a test provision offence ” ; c in paragraph (3)— i for sub-paragraph (a) substitute— a “authorised person”— i in relation to an operator offence, has the meaning given by regulation 20(9)(b); ii in relation to a test provision offence, has the meaning given by regulation 20(9)(ba); ; ii in sub-paragraph (b), at the end insert— ; c “ test provision offence ” has the meaning given by regulation 20(9)(e) . Amendment of Schedule 1 11 1 Schedule 1 (category 1 countries and territories) is amended as follows. 2 In the appropriate place in the alphabetical order insert— a “The Azores”; b “Canada”; c “Denmark”; d “Finland”; e “Liechtenstein”; f “Lithuania”; g “Switzerland”. Amendment of Schedule 3 12 1 Schedule 3 (category 3 countries and territories) is amended as follows. 2 In the appropriate place in the alphabetical order insert— a “Montenegro”; b “Thailand”. Amendment of Schedule 4 13 1 Schedule 4 (exemptions) is amended as follows. 2 In paragraph 1— a in sub-paragraph (2)— i in paragraph (a)(i), for “England”, the second time it occurs, substitute “ the United Kingdom ” ; ii in paragraph (b), at the end, insert “ or, where the relevant international event is the COP, P is a registered participant for the COP ” ; iii in paragraph (d), at the end, insert “ and has not withdrawn this confirmation ” ; b in sub-paragraph (4)— i in paragraph (d)(ii), for “sub-paragraph (a)” substitute “ sub-paragraph (i) ” ; ii in paragraph (ga)— aa after sub-paragraph (i), insert— ia the COP; ; bb after sub-paragraph (ii), insert— iia the COP World Leaders Summit event; ; iii after paragraph (ga), insert— gb “ registered participant ”, in relation to the COP, means a person who has been registered to attend the COP with the secretariat of the United Nations Framework Convention on Climate Change, and has confirmation of their registration from the secretariat; ; iv in paragraph (h), for “G7 event” both times it occurs, substitute “ relevant international event ” . 3 In paragraph 44, in sub-paragraph (3)(b) after “Tokyo” insert “ or Beijing ” . 4 Omit paragraphs 44A and 44B . 5 At the end insert— 49 1 A London Fashion Week invitee. 2 For the purposes of this paragraph— a a person (“P”) is a London Fashion Week invitee if— i P has travelled to England in order to undertake work, or to care for a child who is to undertake work, at or in connection with one or more events forming part of London Fashion Week, ii P's work, or the work that the child for whom P is caring, is integral to the operation of the events mentioned in sub-paragraph (i), iii P, or the child for whom P is caring, could not reasonably undertake the work if required to self-isolate, iv the British Fashion Council has confirmed in writing to the Secretary of State that— aa P is travelling to England to undertake activities as described in sub-paragraph (i); bb P's activity is as described in sub-paragraph (ii); and cc P could not undertake the activity if required to self-isolate, and v the Secretary of State has confirmed in writing to the British Fashion Council that P is a London Fashion Week invitee and has not withdrawn that confirmation; b “ London Fashion Week ” means the fashion events approved by the British Fashion Council for the London Fashion Week schedule taking place in London between 17th September and 21st September 2021 and includes activities taking place in advance of those dates which are related to London Fashion Week. 3 The conditions referred to in regulation 9(15)(ic) are that— a P possesses, on arrival in England, written evidence from the British Fashion Council of P's status as a London Fashion Week invitee; and b P travels directly to and remains in any place where P will be self-isolating apart from when P is travelling to or from, or attending the location of any London Fashion Week event or location at which P is required to undertake activities in connection with a London Fashion Week event. . Insertion of Schedule 4A 14 After Schedule 4, insert— SCHEDULE 4A Conference of the Parties Representatives Regulation 3(12) 1 A representative of a party to the United Nations Framework Convention on Climate Change, a party to the Kyoto Protocol or a party to the Paris Agreement who is, or is to be, a representative at the COP. 2 A representative of an observer state who is, or is to be, a representative at the COP. 3 A representative of the Executive Board of the Clean Development Mechanism who is, or is to be, a representative at a meeting hosted by the Executive Board forming part of the COP. 4 An executive head of a specialized agency of the United Nations, or a person acting on their behalf, who is, or is to be, a representative at the COP and who is participating in or performing official functions in connection with the COP. 5 An officer of a specialized agency of the United Nations, other than a person who is locally recruited and assigned to hourly rates of pay, who is, or is to be, a representative at the COP and who is participating in or performing official functions in connection with the COP. 6 An expert performing a mission for a specialized agency of the United Nations who is, or is to be, a representative at the COP and who is participating in or performing official functions in connection with the COP. 7 An official of the Adaptation Fund, the Green Climate Fund or the Global Environment Facility who is, or is to be, a representative at the COP and who is essential to the participation of that organisation in the COP in order to enable that organisation to discharge, and report on, its mandate to— a the 26th session of the Conference of the Parties, b the 16th session of the Conference of the Parties serving as the meeting of the Parties to the Kyoto Protocol, or c the third session of the Conference of the Parties serving as the meeting of the Parties to the Paris Agreement. 8 An officer of the United Nations, other than a person who is locally recruited and assigned to hourly rates of pay, who is participating in or performing official functions in connection with the COP. 9 An expert, other than an officer of the United Nations, who is performing a mission on behalf of the United Nations in connection with the COP. 10 A representative of an international organisation, within the meaning of paragraph 1(4)(e) of Schedule 4, who is participating in or performing official functions in connection with the COP. 11 In this Schedule— a “ observer state ” means an observer state referred to in— i paragraph 6 of Article 7 of the United Nations Framework Convention on Climate Change, ii paragraph 8 of Article 13 of the Kyoto Protocol, or iii paragraph 8 of Article 16 of the Paris Agreement; b the specialized agencies of the United Nations are— i the Food and Agriculture Organization; ii the International Civil Aviation Organization; iii the International Fund for Agricultural Development; iv the International Labour Organization; v the International Monetary Fund; vi the International Maritime Organization; vii the International Telecommunications Union; viii the United Nations Educational, Scientific and Cultural Organization; ix the United Nations Industrial Development Organization; x the Universal Postal Union; xi the World Bank, comprising— aa the International Bank for Reconstruction and Development; bb the International Development Association; cc the International Finance Corporation; dd the International Centre for Settlement of Investment Disputes; and ee the Multilateral Investment Guarantee Agency; xii the World Health Organization; xiii the World Intellectual Property Organization; xiv the World Meteorological Organization; xv the World Tourism Organization. . Amendment of Schedule 5 15 1 Schedule 5 (list of sporting events) is amended as follows. 2 Omit the following entries— a “GB Taekwondo Fight Night II – International Taekwondo, Para Taekwondo and Karate Event”; b “Boxing Road to Tokyo”; c “Manchester Squash Open 2021”; d “Royal Windsor Horse Show”; e “The 2020 UEFA European Football Championship”; f “European Tour – English Championships”; g “European Tour – Farmfoods European Legends Link Championship”; h “European Tour – Aberdeen Standard Investments Scottish Open”; i “Ladies European Tour – Aramco Team Series”; j “R & A – The Open Championship (including open final qualifying)”; k “European Tour – The Senior Open Presented by Rolex (including qualifiers)”; l “European Tour – Wales Open”; m “European Tour – ISPS HANDA World Invitation presented by Modest Golf Management”; n “European Tour – Staysure PGA Seniors Championship”; o “Ladies European Tour – ISPS HANDA World Invitational”; p “The Coral Eclipse – Sandown horse-racing”; q “The Moet & Chandon July Festival at Newmarket horse-racing”; r “QIPCO King George Diamond Weekend horse-racing”; s “Qatar Goodwood Festival horse-racing”; t “European Tour – Hero Open”; u “European Tour – English Open”; v “Ladies European Tour – Trust Golf Women's Scottish Open”; w “R & A – The AIG Women's Open (including qualifying)”; x “Allam British Open Squash Championships”; y “British Reining Sherwood Circuit “Summer Sizzler”; z “44Cup Cowes”; aa “Rugby League World Cup”. 3 At the end insert— Professional Darts Corporation – Women's Series Men's British Basketball League Women's British Basketball League World Snooker Tour – Scottish Open Qualifiers Motorsport UK – Goodwood Revival Car Race International Boxing – Scott Calow Promotions CEV Champions League Volleyball HSBC UK National Time Trial Championships 2021 HSBC UK National Circuit Race Championships 2021 HSBC UK National Road Race Championships 2021 World Snooker Tour – European Open Qualifiers Motorsport UK – Formula Ford Festival Motorsport UK – Walter Hayes Trophy Motorsport UK – RAC Historic Trophy World Snooker Tour – English Open World Snooker Tour – Welsh Open Qualifiers World Snooker Tour – UK Championship Champion of Champions Snooker Scottish Badminton Open 2021 Canary Wharf Squash Classic 2021 Professional Darts Corporation – Grand Slam of Darts Professional Darts Corporation – Players Championship Finals The Killik Cup Motorsport UK – Roger Albert Clark Rally UEFA Women's Euro England 2022 Football Championships . Amendment of Schedule 8 16 1 Schedule 8 (mandatory testing after arrival in England) is amended as follows. 2 In paragraph 10 (required circumstances for undertaking a day 2 test or a day 8 test)— a omit sub-paragraph (3A) ; b in sub-paragraph (4)— i in the opening words, omit “or (3A)”; ii in paragraph (a), omit “and (3A)”. 3 In paragraph 11 (notification of test results)— a in the opening words of sub-paragraph (2), for “within 24 hours of the result becoming available” substitute “ within 48 hours of the time when the sample taken for the purposes of the test is received by the diagnostic laboratory ” ; b in sub-paragraph (4), after “4ZA” insert “ , 4ZB ” ; c in sub-paragraph (5), omit paragraph (ba). Amendment of Schedule 10 17 1 Schedule 10 (optional testing after arrival in England) is amended as follows. 2 In paragraph 4 (required circumstances for undertaking testing)— a omit sub-paragraph (ba) ; b in sub-paragraph (c)— i in the opening words, omit “or (ba)”; ii in paragraph (i), omit “and (ba)”. 3 In paragraph 5 (notification of test results)— a in the opening words of sub-paragraph (2), for “within 24 hours of the result becoming available” substitute “ within 48 hours of the time when the sample taken for the purposes of the test is received by the diagnostic laboratory ” ; b in sub-paragraph (6), omit paragraph (ba). Amendment of Schedule 11 18 1 Schedule 11 (additional measures applicable to arrivals from category 3 countries and territories) is amended as follows. 2 In paragraph 2— a in sub-paragraph (1) i in paragraph (g)— aa in sub-paragraph (i), at the beginning, insert “ subject to sub-paragraph (2A), ” , bb in sub-paragraph (x) , after “Georgia” insert “ , Montenegro ” , ii omit paragraph (m) ; b after sub-paragraph (2), insert— 2A Notwithstanding paragraph 2(1), this Schedule applies to a person (“P”) who— a is a person described in paragraph 1(2) of Schedule 4, where the relevant international event referred to in that paragraph is the COP, and b is not— i a person invited by Her Majesty's Government to attend both the COP World Leaders summit event and the COP, or ii a person described in Schedule 4A. 2B Where sub-paragraph (2A) applies, and P also satisfies— a the requirements in regulation 2A(3), (4), (4A), (5), or (6), or b the requirements in sub-paragraphs (2C) and (2D), this Schedule applies to P as if, in paragraph 10(a), the reference to “10 days” were a reference to “5 days”. 2C P satisfies the requirements in this sub-paragraph if— a P has completed a course of doses of an authorised vaccine, and P received the final dose before the start of the period beginning with the 9th day before the date of P's arrival in the United Kingdom, b P has participated, or is participating, in a clinical trial regulated by the relevant regulator in the country where the trial is carried out of a vaccine for vaccination against coronavirus, or c P is under the age of 18 when P enters the United Kingdom for the purposes of attending or facilitating the COP. 2D P satisfies the requirements in this sub-paragraph if P has declared on the Passenger Locator Form that P meets the applicable requirement in sub-paragraph (2C). 2E For the purposes of sub-paragraph (2C)— a P has completed a course of doses of an authorised vaccine if P has received the complete course of doses of the authorised vaccine as specified in the manufacturer's guidance for that vaccine; b “ authorised vaccine ” means a vaccine against coronavirus authorised, in relation to doses received in another country, for supply in that country— i following evaluation by the relevant regulator for that country, or ii otherwise by the government of that country, or pursuant to its authority; c in paragraph (b), “ another country ” means a country other than the United Kingdom or a country which is a relevant country for the purposes of regulation 2A. . 3 In paragraph 4, after sub-paragraph (fa) insert— fb Newcastle International Airport; . 4 In paragraph 16, after sub-paragraph (a) insert— aa if no person has responsibility for P when P is travelling to England— i a responsible adult must be nominated before P arrives in England, to have responsibility for P during P's period of self-isolation in accordance with this Schedule, ii P must on their arrival in England be in possession of a booking for the responsible adult nominated under paragraph (i) for a place in accommodation with P, and iii the responsible adult must reside in the place where P is residing in accordance with paragraph 17; . 5 In paragraph 18— a in sub-paragraph (3)(a) for “2020” substitute “ 2021 ” ; b after sub-paragraph (3) insert— 3A P is also a relevant person if— a P is a child on the day P arrives in England; b P travels to the UK for the purposes of receiving education at a further education institution or higher education provider in England or Wales at which education and accommodation is due to be provided for P; c P is not accompanied into the UK by an individual who has responsibility for P; and d the Secretary of State has confirmed in writing that this paragraph applies in relation to P and has not withdrawn that confirmation. . c in sub-paragraph (7), at the end insert— d “ further education institution ” means an institution within the further education sector within the meaning of section 91(3) of the Further and Higher Education Act 1992 ; e “ higher education provider ” has the meaning in section 83(1) of the Higher Education and Research Act 2017 . . Amendment of Schedule 13 19 1 Schedule 13 (prohibition on the arrival of aircraft and vessels into England) is amended as follows. 2 In paragraph 2(1), move the terminal “or” from after paragraph (b) to after paragraph (c), and after that insert— d the circumstances specified in regulation 18(2)(c) apply in relation to the aircraft. . 3 In paragraph 4— a after sub-paragraph (fa) insert— fb Montenegro; ; b after sub-paragraph (ia) insert— iaa Thailand; . Amendment of Schedule 14 20 1 Schedule 14 (amounts of fixed penalties) is amended as follows. 2 In paragraph 11 for “or 16(a)” substitute “ , 16(a) or (aa) ” . 3 In paragraph 12A , in the opening words for “or 16(a)” substitute “ , 16(a) or (aa) ” . 4 After paragraph 16A (fixed penalty for breach of operator system records requirement) insert— Regulation 19(13B)(a) 16B Breach of requirement under regulation 18A(1) or (2) (requirements on test providers)— a in the case of a first fixed penalty notice, £2,500; b in the case of a second fixed penalty notice, £5,000; c in the case of a third fixed penalty notice, £10,000. Regulation 19(13B)(b) 16C Breach of requirement under regulation 18B(1) (requirements on other persons providing testing services)— a in the case of a first fixed penalty notice, £2,500; b in the case of a second fixed penalty notice, £5,000; c in the case of a third fixed penalty notice, £10,000. . 5 In paragraph 17 (fixed penalty for wilful obstruction), after sub-paragraph (d) insert— da obstruction of a function relating to regulation 18A(1) or (2) or 18B(1)— i in the case of a first fixed penalty notice, £2,500; ii in the case of a second fixed penalty notice, £5,000; iii in the case of a third fixed penalty notice, £10,000; . Amendments to the Health Protection (Notification) Regulations 2010 21 1 The Health Protection (Notification) Regulations 2010 are amended as follows. 2 In regulation 4 (duty to notify PHE of results of influenza and SARS-Cov-2 tests)— a in paragraph (2)— i after sub-paragraph (a) insert— aa the date and time the sample was received by the diagnostic laboratory; ; ii in sub-paragraph (l), after “positive” insert “ or indeterminate ” ; b in paragraph (3A), for “A notification” substitute “ Subject to paragraph (3D), a notification ” ; c in paragraph (3C), for “A notification” substitute “ Subject to paragraph (3D), a notification ” ; d for paragraph (3D) substitute— 3D A notification which— a is under paragraph (1)(a) or (b) or (1A)(a), and b relates to— i a day 2 or a day 8 test within the meaning of regulation 6 of the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021, or i a test undertaken in accordance with regulation 9(16) of those Regulations, must be provided within 48 hours of the time the diagnostic laboratory received the test sample. 3 In regulation 4ZA (duty to notify PHE of results of mandatory tests)— a in paragraph (2), omit sub-paragraph (d)(viii) and (ix). b for paragraph (3) substitute— 3 Where the specimen is to be sent to another laboratory for the purposes of sequencing pursuant to paragraph 7(1)(h) or 9(1)(h) of Schedule 8 to the International Travel and Operator Liability Regulations, the operator of the diagnostic laboratory must provide that other laboratory with the specimen number used to fulfil the obligation in paragraph (2)(d)(iii). . 4 After regulation 4ZA insert— Duty to notify the UK Health Security Agency of the results of genomic sequencing of mandatory test samples under the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021 4ZB 1 The operator of a sequencing laboratory must notify the UK Health Security Agency in accordance with this regulation. 2 The notification must include the following information so far as it is known to the operator of the sequencing laboratory— a where the sequencing laboratory is not the source laboratory— i the name and address of the source laboratory; ii the date and time that the specimen was received by the sequencing laboratory; b a report of the results of the sequencing; c the date of that report; d where the specimen has been sequenced on or after 15th March 2021, a sorted BAM file containing all reads aligning to the SARS-Cov-2 reference genome with unaligned human reads removed; e any metadata required to reproduce the analysis which produced the results of the sequencing; f the following information about the specimen— i any laboratory comments; ii the organism code; iii the specimen number; iv the specimen type; v the specimen date; vi the test method applied; vii cycle threshold values; viii whether the specimen is a variant of concern or a variant under investigation. 3 Where the sequencing laboratory is not the source laboratory— a the notification must be provided in writing within 96 hours of receiving the specimen, and b the sequencing laboratory must— i ascertain the specimen number that the source laboratory used to fulfil its obligation in regulation 4ZA(2)(d)(iii) in respect of the specimen, and ii use the same specimen number to fulfil the obligation in paragraph (2)(f)(iii). 4 Where the sequencing laboratory is the source laboratory— a the notification must be provided in writing within 120 hours of the time SARS-Cov-2 is identified in the specimen, and b the sequencing laboratory must use the same specimen number to fulfil the obligation in paragraph (2)(f)(iii) as it used to fulfil the obligation in regulation 4ZA(2)(d)(iii). 5 It is an offence for the operator of a sequencing laboratory to fail without reasonable excuse to comply with this regulation. 6 Any person who commits an offence under this regulation is liable on summary conviction to a fine. 7 In this regulation— “ director of a sequencing laboratory ” means— the clinical microbiologist, consultant pathologist or other registered medical practitioner or other person in charge of the sequencing laboratory, or any other person working in the sequencing laboratory to whom the function of making a notification under this regulation has been delegated by the person mentioned in sub-paragraph (a); “ operator of a sequencing laboratory ” means the corporate body that operates the sequencing laboratory or, if there is no such body, the director of the sequencing laboratory; “ sequencing laboratory ” means a laboratory which sequences a sample pursuant to paragraph 7(1)(h) or 9(1)(h) of Schedule 8 to the Health Protection (Coronavirus, International Travel and Operator Liability) (England) Regulations 2021; “ source laboratory ” means the diagnostic laboratory which provided the notification required by article 4(1) and 4ZA(1) in respect of the specimen. . 5 In regulation 4A (duty on test providers to notify test results)— a renumber paragraph (7) as paragraph (6); b in sub-paragraph (a) of paragraph (6) (as renumbered in accordance with this regulation), for “(6)” substitute “ (5) ” ; c renumber paragraph (8) as paragraph (7); d renumber paragraph (9) as paragraph (8); e renumber paragraph (10) as paragraph (9). 6 In paragraph (1)(a) of regulation 7 (electronic communications)— a after “4(1)” insert “ and (1A) ” ; b after “4ZA” insert “ , 4ZB ” . Nadine Dorries Minister of State Department of Health and Social Care