Regulatory Updates

Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program

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Distribution date: 23 May 2022

TITLE: Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program; Withdrawal of Proposed RuleAGENCY: Environmental Protection Agency (EPA)ACTION: Proposed rule; withdrawal and partial withdrawalSUMMARY: On 6 October 2021, the U.S. Environmental Protection Agency issued a supplemental proposed rulemaking under the Significant New Alternatives Policy program to list certain substitutes to ozone- depleting substances in the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, as acceptable, subject to narrowed use limits, from the effective date of a subsequent final rule until 1 January 2023. This followed EPA's 12 June 2020, initial proposal which proposed to list three foam blowing agents, which are hydrofluorocarbon blends, as acceptable. Taking into consideration information available to EPA since issuance of that initial proposal, EPA proposed narrowed use limits and time-limited use of the substitutes in the supplemental proposal. Based on further information available to EPA, EPA is now withdrawing the proposed listings for the three foam blowing agents described in the initial and supplemental proposals. This document summarizes the proposed listings and provides an explanation for the Agency's decision not to finalize the proposed actions.DATES: The U.S. EPA is withdrawing the proposed rule published on 6 October 2021 (86 FR 55549; FRL-7826.1-02-OAR); and is partially withdrawing the proposed rule published on 12 June 2020 (85 FR 35874; FRL-10009-66-OAR), by withdrawing the listings described in the table ("SUMMARY OF PROPOSED NEW LISTINGS FOR XPS FOAM BLOWING AGENT") published at 85 FR 35888-35889 on 12 June 2020, as of 20 May 2022.This proposed rule; withdrawal and partial withdrawal 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.

Products Covered: Chemical substances

Regulation Type: Addendum to Regular Notification

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 23 May 2022 | Final date for Comment: 22 July 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Afidopyropen.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Mate and spices (HS codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.01, 10.04, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Pesticides Food safety Human health

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 23 May 2022 | Final date for Comment: 22 July 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Afidopyropen.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.04, 08.05, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Mate and spices (HS codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.01, 10.04, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Pesticides Food safety Human health

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 23 May 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Ampicillin.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Veterinary drugs Food safety Human health

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 23 May 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug: Ampicillin.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Veterinary drugs Food safety Human health

Rectification of annex II - Conformity Identification Seal, of Inmetro Ordinance No. 456, 16 November 2021, published in the Official Gazette on 18 November 2021, pages 62 to 64, section 1.

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Distribution date: 20 May 2022

https://www.in.gov.br/web/dou/-/retificacao-401098771 

Products Covered: Hydraulic brake fluids for automotive vehicles (HS 381900)

Regulation Type: Corrigendum to Regular Notification

Rectification of annex II - Conformity Identification Seal, of Inmetro Ordinance No. 456, 16 November 2021, published in the Official Gazette on 18 November 2021, pages 62 to 64, section 1.

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Distribution date: 20 May 2022

https://www.in.gov.br/web/dou/-/retificacao-401098771 

Products Covered: Hydraulic brake fluids for automotive vehicles (HS 381900)

Regulation Type: Corrigendum to Regular Notification

National Standard of the P.R.C., Medical electrical equipment –Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

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Distribution date: 18 May 2022 | Final date for Comment: 17 July 2022

This document applies to the basic safety and essential performance of functional NIRS equipment intended to be used by themselves, or as a part of an ME system, for adjunctive diagnostic purposes.Not included within the scope of this particular standard are:a) the equipment, as a part of ME equipment,  measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules);b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining functional NIRS equipment output;c) pulse oximeter equipment, which is not intended for obtaining functional NIRS equipment output. The requirements for pulse oximeter equipment are found in YY 9706.261.d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy may be subject to different test procedures than those defined herein.e) functional near-infrared spectroscopy equipment, which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin may be subject to different test procedures than those defined herein.

Products Covered: Near infrared functional brain imaging device, near infrared spectral functional brain imaging system, quantitative brain function imaging device (HS code(s): 901820; 902750; 903149); (ICS code(s): 11.040.55)

Regulation Type: Regular notification

Human health

National Standard of the P.R.C., Medical electrical equipment –Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

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Distribution date: 18 May 2022 | Final date for Comment: 17 July 2022

This document applies to the basic safety and essential performance of functional NIRS equipment intended to be used by themselves, or as a part of an ME system, for adjunctive diagnostic purposes.Not included within the scope of this particular standard are:a) the equipment, as a part of ME equipment,  measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules);b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining functional NIRS equipment output;c) pulse oximeter equipment, which is not intended for obtaining functional NIRS equipment output. The requirements for pulse oximeter equipment are found in YY 9706.261.d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy may be subject to different test procedures than those defined herein.e) functional near-infrared spectroscopy equipment, which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin may be subject to different test procedures than those defined herein.

Products Covered: Near infrared functional brain imaging device, near infrared spectral functional brain imaging system, quantitative brain function imaging device (HS code(s): 901820; 902750; 903149); (ICS code(s): 11.040.55)

Regulation Type: Regular notification

Human health

National Standard of the P.R.C., Self-rescuer For Coal Mine

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Distribution date: 18 May 2022 | Final date for Comment: 17 July 2022

This document stipulates the category, technical requirements, testing methods, inspection rules, marking, packing, transportation and storage of coal mine self-rescuer( including chemical oxygen self-rescuer and compressed oxygen self-rescuer).This document applies to chemical oxygen self-rescuer  and compressed oxygen self-rescuer used in coal mines.

Products Covered: Self-rescuer for coal mine(including chemical  oxygen self-rescuer and compressed oxygen self-rescuer) (HS code(s): 9020); (ICS code(s): 13.100)

Regulation Type: Regular notification

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