Distribution date: 07 October 2021 | Final date for Comment: 22 November 2021

TITLE: Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program; Supplemental Proposal AGENCY: Environmental Protection Agency (EPA) ACTION: Supplemental notice of proposed rulemaking SUMMARY: Pursuant to the U.S. Environmental Protection Agency's Significant New Alternatives Policy program, the Agency is proposing, as an additional option, to list for a limited period of time certain substances in the foamblowing sector, extruded polystyrene: Boardstock and billet end-use, as acceptable, subject to narrowed use limits. This proposal supplements the Agency's 12 June 2020, proposal with respect to the proposed listings in the foam-blowing sector, taking into consideration public comments and information received since issuance of the initial proposal. In the 12 June 2020, proposal, EPA proposed to list three foam blowing agent blends as acceptable. In this supplemental proposal, EPA is proposing an additional approach to list these blends as acceptable, subject to narrowed use limits, in the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, from the effective date of a final rule based on this supplemental proposal until 1 January 2023. The Agency is providing an opportunity for public comment on this additional approach for the listings in the foam blowing sector, as well as reopening the public comment period for the proposed listings in the foam blowing sector in the 12 June 2020, proposal. The Agency is not reopening for comment those other portions of the 12 June 2020, proposal which are addressed in a separate final rule issued 6 May 2021. DATES: Comments on this supplemental proposal must be received on or before 22 November 2021. Any party requesting a public hearing must notify the contact listed below under FOR FURTHER INFORMATION CONTACT by 5 p.m. Eastern Daylight Time on 12 October 2021. If a virtual hearing is held, it will take place on or before 21 October 2021 and further information will be provided on EPA's Stratospheric Ozone website at www.epa.gov/snap. This supplemental notice of proposed rulemaking and previous actions notified under the symbol G/TBT/N/USA/1626 are identified by Docket Number EPA-HQ-OAR-2019-0698. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OAR-2019-0698/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with the regulator and will also be submitted to the Docket on Regulations.gov if received within the comment period.

Products Covered: Chemical substances

Regulation Type: Addendum to Regular Notification

Distribution date: 08 October 2021 | Final date for Comment: 09 May 2025

The proposed maximum residue limits (MRLs) for Bifenthrin notified in G/SPS/N/JPN/706 (dated 17 December 2019) were adopted and published on 23 April 2020.The specified MRLs are available as below:

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 08 October 2021 | Final date for Comment: 09 May 2025

The proposed maximum residue limits (MRLs) for Diazinon notified in G/SPS/N/JPN/711 (dated 17 December 2019) were adopted and published on 23 April 2020.The specified MRLs are available as below:

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 08 October 2021 | Final date for Comment: 07 November 2021

Amendment of the provisions for Potency test in the “Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)”. Amendment of the provisions for Final bulk and final product in the “Polyethylene Glycol-treated Human Anti-HBs Immunoglobulin”, and for Test procedures in the “Test for Measuring the Potency of Human Anti-HBs Immunoglobulin”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 12 October 2021 | Final date for Comment: 09 May 2025

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Products Covered: Pharmaceutical products (HS code(s): 30); Essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS code(s): 33); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, fly-papers). (HS code(s): 3808); Pharmaceutics (ICS code(s): 11.120); Pesticides and other agrochemicals (ICS code(s): 65.100); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Addendum to Regular Notification

Distribution date: 14 October 2021 | Final date for Comment: 09 May 2025

Products Covered:

Regulation Type: Corrigendum to Regular Notification

Distribution date: 15 October 2021 | Final date for Comment: 14 November 2021

Amendment of the provisions for fee and quantity in the “Recombinant Adsorbed Hepatitis B Vaccine (Prepared from Yeast)”. Deletion of the provision for MPL content test in “Recombinant Adsorbed Bivalent Human Papillomavirus-like particle  Vaccine (derived from Trichoplusia ni cells)”. Deletion of a part of the provision for  potency test in “Human prothrombin complex” and “Freeze-dried activated human blood coagulation factor VII concentrate containing factor X.” Deletion of the provision for rabbit pyrogen test in “Freeze-dried ion-exchange-resin treated human normal immunoglobulin” and “Human anti-thrombin III.”

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 18 October 2021 | Final date for Comment: 09 May 2025

The Resolution – RDC number335, 24 January 2020 - previously notified through G/TBT/N/BRA/961 – which establishes the criteria and procedure for the import of Cannabis-based products per individual person, for personal use, upon medical prescription from a legally qualified professional, for health treatment, was changed by Resolution - RDC number 570, 6 October 2021. 

Products Covered: HS CODE: 30049099; 3006; 5302 (cannabis-based medicine, its derivatives and synthetic analogues)

Regulation Type: Addendum to Regular Notification

Distribution date: 20 October 2021 | Final date for Comment: 09 May 2025

We are publishing a protocol under regulation 39A of the Medical Devices Regulations 2002 which will allow certain Coronavirus test devices to remain on the market after 31 October without approval under regulation 38A(5).  These tests are the subject of a pending application for validation approval and will have to be removed from the market within 10 working days if their application is refused.  Permitting the tests listed in the protocol to remain on the market without approval is considered a necessary and proportionate measure to address the serious public health risk that a shortage of tests could create over the winter.  The protocol will expire on 28 February 2022.

Products Covered: HS3822

Regulation Type: Addendum to Regular Notification

Distribution date: 21 October 2021 | Final date for Comment: 20 December 2021

This Working Draft East African Standard defines the terms used in the disinfectant and antiseptic industry.

Products Covered: Disinfectants, put up in forms or packings for retail sale or as preparations or articles (excl. goods of subheading 3808.59) (HS code(s): 380894); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification