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Welsh Statutory Instruments
Public Health, Wales
Made
at 2.15 p.m. on 6 August 2021
Laid before Senedd Cymru
at 5.00 p.m. on 6 August 2021
Coming into force in accordance with regulation 1(2) and (3)
The Welsh Ministers, in exercise of the powers conferred on them by sections 45B and 45P(2) of the Public Health (Control of Disease) Act 1984( 1), make the following Regulations.
1.—(1) The title of these Regulations is the Health Protection (Coronavirus, International Travel and Operator Liability) (Wales) (Miscellaneous Amendments) (No. 4) Regulations 2021.
(2) Except for regulation 7, these Regulations come into force at 4.00 a.m. on 8 August 2021.
(3) Regulation 7 comes into force on 23August 2021.
2. The Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020( 2) are amended in accordance with regulations 3 to 7.
3. In regulation 2A(2), omit “or Metropolitan France”.
4. In Schedule 3 (exempt countries and territories outside the common travel area), in Part 1, at the appropriate places insert—
“Austria ”
“Germany ”
“Latvia ”
“Norway ”
“Romania ”
“Slovakia ”
“Slovenia ”.
5. In Schedule 3A (countries and territories subject to additional measures)—
(a) at the appropriate places insert—
“Georgia ”
“Mayotte ”
“Mexico ”
“Réunion ”;
(b) omit—
“Bahrain ”
“India ”
“Qatar ”
“United Arab Emirates ”.
6. In Schedule 1E (specified testing events), at the appropriate place insert “R & A – The Curtis Cup”.
7.—(1) Schedule 1C (mandatory testing after arrival in Wales) is amended as follows.
(2) In sub-paragraph (b)(ii) of paragraph 1 (day 2 test requirements)—
(a) after “greater than” insert “or equal to”;
(b) for “with” substitute “or”.
(3) For paragraph 2 (day 8 test requirements) substitute—
2. A day 8 test complies with this sub-paragraph where—
(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) the manufacturer of any device used for the purposes of the test states that the device—
(i) uses an established molecular detection method,
(ii) has a specificity greater than or equal to 97% (or a 95% two-sided confidence interval entirely above 95%),
(iii) has a sensitivity greater than or equal to 95% (or a 95% two-sided confidence interval entirely above 90%),
(iv) has a limit of detection of less than or equal to 1000 SARS-CoV-2 copies per millilitre, and
(v) is suitable for identifying every variant of concern, and
(c) 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( 3) , 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. ”
8. In regulation 5C of the Health Protection (Coronavirus, International Travel, Pre-Departure Testing and Operator Liability) (Wales) (Amendment) Regulations 2021( 4), omit paragraph (4).
Eluned Morgan
Minister for Health and Social Services, one of the Welsh Ministers
At 2.15 p.m. on 6 August 2021
(This note is not part of the Regulations)
These Regulations amend the Health Protection (Coronavirus, International Travel) (Wales) Regulations 2020 ( S.I. 2020/574 (W. 132)) (the “International Travel Regulations”) and the Health Protection (Coronavirus, International Travel, Pre- Departure Testing and Operator Liability) (Wales) (Amendment) Regulations 2021 ( S.I. 2021/48 (W. 11)) (the “Operator Liability Regulations”).
The International Travel Regulations impose requirements on persons entering Wales after having been abroad. They include a requirement for persons arriving in Wales to isolate for a period determined in accordance with those Regulations. The requirements imposed by the International Travel Regulations are subject to exceptions, and certain categories of person are exempt from having to comply. Persons entering Wales after being in one or more of the countries and territories listed in Schedule 3 to the International Travel Regulations are not required to isolate. The countries and territories listed in Schedule 3 are referred to as “exempt countries and territories”.
Regulation 3 amends regulation 2A of the International Travel Regulations so that the exemptions in regulation 2A now extend to persons travelling from Metropolitan France.
Regulation 4 amends Schedule 3 to the International Travel Regulations to add Austria, Germany, Latvia, Norway, Romania, Slovakia and Slovenia to the list of exempt countries and territories outside the common travel area.
Regulation 5 amends Schedule 3A to the International Travel Regulations, which contains the list of countries and territories subject to additional measures. Non-exempt persons are prohibited from entering Wales where they have been in a country or territory listed in Schedule 3A within the last 10 days of arrival, pursuant to regulation 12E of the International Travel Regulations. Regulation 5 adds Georgia, Mayotte, Mexico and Réunion to the list in Schedule 3A and removes Bahrain, India, Qatar and the United Arab Emirates.
Regulation 6 of these Regulations amends Schedule 1E to the International Travel Regulations to add the Curtis Cup to the list of ‘specified events’. This removes relevant persons at the event from the testing provisions in regulation 6AB of the International Travel Regulations and instead requires them to adhere to the requirements in regulation 6L of those Regulations.
Regulation 7 amends paragraphs 1 and 2 of Schedule 1C to the International Travel Regulations to bring the technical requirements for day 8 tests into line with the more stringent requirements for day 2 tests.
The Operator Liability Regulations impose requirements on persons operating international passenger services (“operators”) arriving into Wales from outside the common travel area. In accordance with those requirements operators must, for example, ensure that passengers travelling on such services possess notification of a negative test result and have made arrangements to take further tests following their arrival.
Regulation 8 makes a consequential amendment to regulation 5C of the Operator Liability Regulations in light of the amendment to regulation 2A of the International Travel Regulations to extend the exemptions in regulation 2A to persons travelling from Metropolitan France.
The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, a regulatory impact assessment has not been prepared as to the likely costs and benefits of complying with these Regulations.
1984 c. 22. Part 2A was inserted by section 129 of the Health and Social Care Act 2008 (c. 14). The function of making regulations under Part 2A is conferred on “the appropriate Minister”. Under section 45T(6) of the 1984 Act the appropriate Minister as respects Wales, is the Welsh Ministers.
S.I. 2020/574 (W. 132), amended by S.I. 2020/595 (W. 136), S.I. 2020/714 (W. 160), S.I. 2020/726 (W. 163), S.I. 2020/804 (W. 177), S.I. 2020/817 (W. 179), S.I. 2020/840 (W. 185), S.I. 2020/868 (W. 190), S.I. 2020/886 (W. 196), S.I. 2020/917 (W. 205), S.I. 2020/942, S.I. 2020/944 (W. 210), S.I. 2020/962 (W. 216), S.I. 2020/981 (W. 220), S.I. 2020/1015 (W. 226), S.I. 2020/1042 (W. 231), S.I. 2020/1080 (W. 243), S.I. 2020/1098 (W. 249), S.I. 2020/1133 (W. 258), S.I. 2020/1165 (W. 263), S.I. 2020/1191 (W. 269), S.I. 2020/1223 (W. 277), S.I. 2020/1232 (W. 278), S.I. 2020/1237 (W. 279), S.I. 2020/1288 (W. 286), S.I. 2020/1329 (W. 295), S.I. 2020/1362 (W. 301), S.I. 2020/1477 (W. 316), S.I. 2020/1521 (W. 325), S.I. 2020/1602 (W. 332), S.I. 2020/1645 (W. 345), S.I. 2021/20 (W. 7), S.I. 2021/24 (W. 8), S.I. 2021/46 (W. 10), S.I. 2021/48 (W. 11), S.I. 2021/50 (W. 12), S.I. 2021/66 (W. 15), S.I. 2021/72 (W. 18), S.I. 2021/95 (W. 26), S.I. 2021/154 (W. 38), S.I. 2021/305 (W. 78), S.I. 2021/361 (W. 110), S.I. 2021/454 (W. 144), S.I. 2021/500 (W. 149), S.I. 2021/568 (W. 156), S.I. 2021/584 (W. 161), S.I. 2021/646 (W. 166), S.I. 2021/669 (W. 170), S.I. 2021/765 (W. 187), S.I. 2021/826 (W. 193), S.I. 2021/863 (W. 202), S.I. 2021/867 (W. 203)and S.I. 2021/915 (W. 208).