TITLE: Trichloroethylene; Regulation of Vapor Degreasing Under TSCA Section 6(a); Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a); Reopening of Comment Periods AGENCY: Environmental Protection Agency (EPA) ACTION: Notice; Reopening of comment periods SUMMARY: In the Federal Register of 19 January 2017, EPA issued two proposed rules under section 6 of the Toxic Substances Control Act (TSCA). The first action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of trichloroethylene (TCE) for use in vapor degreasing; to prohibit the use of TCE in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping. The second action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N- methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. This document reopens and extends the comment periods for each proposed rule for an additional 30 days. Commenters requested additional time to submit written comments for the proposed rules. Comments, identified by docket identification (ID) number EPA- HQ-OPPT-2016-0387 and by docket identification (ID) number EPA-HQ-OPPT- 2016-0231 must be received on or before 19 May 2017.
Distribution date: 03 May 2017 | Final date for Comment: 30 April 2025
Products Covered: Trichloroethylene (TCE)
Regulation Type: Addendum to Regular Notification
Commission Implementing Regulation (EU) 2017/731 of 25 April 2017 amending model veterinary certificates BOV-X, BOV-Y, BOV and OVI set out in Annexes I and II to Regulation (EU) No 206/2010, the model certificates GEL, COL, RCG and TCG set out in Annex II to Implementing Regulation (EU) 2016/759 and the model certificate for composite products set out in Annex I to Regulation (EU) No 28/2012 in relation to the rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (Text with EEA relevance)
Distribution date: 03 May 2017 | Final date for Comment: 30 April 2025
Amendments of the model certificates for imports of live domestic bovine animals, fresh meat and minced meat of bovine, ovine and caprine origin, gelatine, collagen, raw material for production of gelatine and collagen, treated raw material for production of gelatine and collagen and of composite products with products of bovine, ovine and caprine origin, as regards the public health attestation for BSE: - Clarification of the text concerning import of live domestic bovine animals and products of animal origin from bovine, ovine or caprine animals. - Amendment of the requirement for import of carcasses of bovine origin, as the requirement to indicate a blue stripe on the label when removal of the vertebral column is not required, is changed to indicate a red stripe on the label when such removal is required. - Modification of the import requirements for the products coming from countries with a negligible BSE risk, to allow also for import when such products originate from raw material from countries with controlled or undetermined BSE risk, provided that SRM has been removed.
Products Covered: Domestic bovine animals, fresh meat (including minced meat) of domestic bovine, ovine and caprine animals, gelatine, collagen, raw material for production of gelatine and collagen, treated raw material for production of gelatine and collagen, composite products.
Regulation Type: Regular notification
TITLE: Trichloroethylene; Regulation of Vapor Degreasing Under TSCA Section 6(a); Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a); Reopening of Comment Periods AGENCY: Environmental Protection Agency (EPA) ACTION: Notice; Reopening of comment periods SUMMARY: In the Federal Register of 19 January 2017, EPA issued two proposed rules under section 6 of the Toxic Substances Control Act (TSCA). The first action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of trichloroethylene (TCE) for use in vapor degreasing; to prohibit the use of TCE in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping. The second action proposed to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N- methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. This document reopens and extends the comment periods for each proposed rule for an additional 30 days. Commenters requested additional time to submit written comments for the proposed rules. Comments, identified by docket identification (ID) number EPA- HQ-OPPT-2016-0387 and by docket identification (ID) number EPA-HQ-OPPT- 2016-0231 must be received on or before 19 May 2017.
Distribution date: 04 May 2017 | Final date for Comment: 30 April 2025
Products Covered: Methylene chloride and N-Methylpyrrolidone
Regulation Type: Addendum to Regular Notification
Indirect Food Additives: Polymers; Final Rule
Distribution date: 05 May 2017 | Final date for Comment: 30 April 2025
The Food and Drug Administration (FDA) is amending the food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closuresealing gaskets for food containers because this use has been abandoned. This action is in response to a petition filed by Keller and Heckman LLP on behalf of the Society of the Plastics Industry, Inc.The rule is effective 4 May 2017.The text is available at http://members.wto.org/crnattachments/2017/SPS/USA/17_2174_00_e.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Amendment to the Enforcement Order of Industrial Safety and Health Act and related ordinances about the 10 substances
Distribution date: 08 May 2017 | Final date for Comment: 15 June 2017
The Enforcement Order of Industrial Safety and Health Act and related ordinances are to be partially amended to place obligations on the business operators relating to the 10 substances.
Products Covered: Asphalt (HS 2706), 1-Chloro-2-propanol (HS 2922), 2-Chloro-1-propanol (HS 2922), S-tert-butylthiomethyl O,Odiethylphosphorodithioate (HS 2930), Phenyl isocyanate (HS 2929), 2,3-Butanedione (HS2914), Boric acid (HS 2810), Portlamd cement (HS 2523), 2-methoxy-2-methylbutane (HS2909), Carbonyl sulphide (HS 2830) and preparations containing them (hereinafter referred to as the "10 substances")
Regulation Type: Regular notification
Proyecto de Reglamento que regula la expedición del certificado de liberación de lote de productos biológicos: vacunas o derivados de plasma humano (Draft Regulation on the issue of batch release certificates for biological products (vaccines or human plasma derivatives)) (6 pages, in Spanish).
Distribution date: 08 May 2017 | Final date for Comment: 02 August 2017
The aims of the notified draft Regulation are to: · establish the rules governing the issue of batch release certificates for biological products (vaccines or human plasma derivatives) issued by the National Authority for Pharmaceutical Products, Medical Devices and Sanitary Products; · establish the information to be included in the documents required for the issue of batch release certificates for biological products (vaccines or human plasma derivatives).
Products Covered: Pharmaceutical products classified under Chapter 30 of the Harmonized System or Customs Tariff
Regulation Type: Regular notification
Proyecto de Reglamento que establece las reglas de clasificación y los principios esenciales de seguridad y desempeño de los dispositivos médicos (Draft Regulation establishing the classification rules for and the essential principles of safety and performance of medical devices) (34 pages, in Spanish)
Distribution date: 08 May 2017 | Final date for Comment: 02 August 2017
The aims of the notified draft Regulation are as follows: · to establish the rules governing the classification of medical devices by risk level, pursuant to Article 6.2 of Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products), for sanitary registration purposes; · to establish the essential principles of safety and performance to be respected by the manufacturers of medical devices in order to demonstrate that such products are safe and perform in accordance with the manufacturer's intended end use.
Products Covered: Medical devices classified under Chapter 30 of the Harmonized System or Customs Tariff
Regulation Type: Regular notification
The Republic of Colombia hereby advises that Articles 10 and 14 of Resolution No. 689 of 3 May 2016 of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development "Adopting the Technical Regulation establishing the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps, and introducing other provisions", notified on 12 May 2016 by the World Trade Organization in document G/TBT/N/COL/214/Add.1, have been amended pursuant to Resolution No. 837 of 4 May 2017. Text available from: http://extranet.comunidadandina.org/SIRT/public/index.aspx Enquiry point: Contact person: Daniel Héctor Rico R. E-mail: [email protected]; [email protected] [email protected] Calle 28 N° 13A - 15, tercer piso Bogotá, D.C., Colombia Tel.: (+57-1) 606-7676, Exts. 1690 and 1340 Website: http://www.mincit.gov.co/publicaciones.php?id=33051 https://members.wto.org/crnattachments/2017/TBT/COL/17_2202_00_s.pdf
Distribution date: 09 May 2017 | Final date for Comment: 30 April 2025
Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;
Regulation Type: Addendum to Regular Notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 16 May 2017 | Final date for Comment: 15 July 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Flutolanil.
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 and 03.04) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.08, 08.10 and 08.11) - Coffee, tea, mate and spices (HS Codes: 09.03 and 09.10) - Cereals (HS Codes: 10.01 and 10.06) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02 and 12.12)- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 16 May 2017 | Final date for Comment: 15 July 2017
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Isoxathion.
Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08)- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07 and 12.12)
Regulation Type: Regular notification
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