Distribution date: 15 September 2017 | Final date for Comment: 06 November 2017

The U.S. Nuclear Regulatory Commission (NRC) has received a petition for rulemaking from Matthew McKinley on behalf of the Organization of Agreement States (OAS) (the Petitioner) dated 14 April 2017, requesting that the NRC revise its regulations to add radionuclides and their corresponding activities to the list of “Quantities of Licensed Material Requiring Labeling.” The petition was docketed by the NRC on 21 June 2017, and has been assigned Docket No. PRM-30-66. The NRC is examining the issues raised in PRM-30-66 to determine whether they should be considered in rulemaking. The NRC is requesting public comment on this petition, including specifically on the question of what products or technologies, other than the germanium-68 generators cited in the petition, are being or could be negatively affected because the radioactive materials required for these products or technologies are not currently listed on the table in appendix B of 10 CFR part 30.  Additionally, NRC solicits feedback on whether the petition raises other issues not addressed by questions in the notice about labelling or decommissioning financial assurance for radioactive materials.

Products Covered: Radioactive materials

Regulation Type: Regular notification

Distribution date: 14 September 2017 | Final date for Comment: 15 October 2017

Under Article 41 of the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Regular notification

Distribution date: 14 September 2017 | Final date for Comment: 08 December 2017

The proposed regulations amend the Regulations on fertilisers etc. of organic origin and the Regulations relating to the payment of fees for specific services provided by the Norwegian Food Safety Authority ("sewage sludge-based fertiliser" etc.). The proposed regulations introduce amendments to the national regulations concerning organic fertilisers containing, amongst other components, also sewage sludge. The proposal introduces the following amendments: - Products with the product designation "sewage sludge-based fertiliser" is to be subject to less stringent use-restriction compared to other sewage-sludge;- The use of the product designation is to be subject to an authorisation from the Norwegian Food Safety Authority. Authorisation may only be given if the product has been treated using methods where the temperature during the hygienisation period is at least 55 degrees Celsius. Furthermore, the product must have a balanced nutrient content adapted to the annual needs of the plants and be suitable for use with at maximum addition of 100kg dry matter per decare per year of the sewage sludge component; - All operators in the delivery-chain are required to keep a record with information necessary for tracing the products. The users of "sewage sludge-based fertiliser" are also required to keep a record stating which enterprise the sludge product was received from, the product's trade name, the quantity received and the date on which it was received. The record shall also contain outline maps showing the areas where the sludge has been used. It must be stated what quantity of sludge has been used per decare and the date on which it was spread; - The records must be stored for at least ten years. The operator is to pay a fee of 3,675 NOK for the authorisation.

Products Covered: Organic fertilisers containing sewage sludge (under Chapter 31.01.0000)

Regulation Type: Regular notification

Distribution date: 12 September 2017

Technical Regulation introducing amendments in the current regulation to include methanol in the definition of solvent and make more effective the control over that product due to its potential to adulterate gasoline and hydrated ethanol. It includes article 7A in Ordinance 312, 27 December 2001, and revokes subsection VIII of article 1st of the Ordinance 170, 20 October 1999.

Products Covered: HS (290511) Methanol (methyl alcohol); HS (2904) Hydrocarbon derivatives.

Regulation Type: Regular notification

Distribution date: 12 September 2017 | Final date for Comment: 08 December 2017

The proposed regulations amending the Regulations on fertilisers etc. of organic origin and the Regulations relating to the payment of fees for specific services provided by the Norwegian Food Safety Authority (‘sewage sludge-based fertiliser’ etc.) introduces amendments to the national regulations concerning organic fertilisers containing, amongst other components, also sewage sludge. The proposal introduces the following amendments:  Products with the product designation ‘sewage sludge-based fertiliser’ is to be subject to less stringent use-restriction compared to other sewage sludge.  The use of the product designation is to be subject to an authorisation from the Norwegian Food Safety Authority. Authorisation may only be given if the product has been treated using methods where the temperature during the hygienisation period is at 55 degrees Celcius. Furthermore, the product must have a balanced nutrient content adapted to the annual needs of the plants and be suitable for use with at maximum addition of 100 kg dry matter per decar per year of the sewage sludge component.  All operators in the delivery-chain are required to keep a record with information necessary for tracing the products.  The users of ‘sewage sludge-based fertiliser’ are also required to keep a record stating which enterprise the sludge product was received from, the product’s trade name, the quantity received and the date on which it was received. The record shall also contain outline maps showing the areas where the sludge has been used. It must be stated what quantity of sludge has been used per decare and the date on which it was spread.  The records must be stored for at least 10 years. The operator is to pay a fee of 3,675 NOK for the authorisation.

Products Covered: 31.01.0000. Organic fertilisers produced from i.e. sewage sludge.

Regulation Type: Regular notification

Distribution date: 12 September 2017 | Final date for Comment: 11 November 2017

So far, composts made of animal wastes as raw materials applied with flocculants and coagulants are only allowed if registered by the Minister of Agriculture, Forestry and Fisheries prior to producing and selling them as fertilizers. Thereafter, by amending the Official Specifications, regulations are to be deregulated to enable composts with flocculants and coagulants to be produced and sold by submitting notification.For details, see the attachment.

Products Covered: Fertilizer (HS: 3101)

Regulation Type: Regular notification

Distribution date: 11 September 2017

Products Covered: Antifreeze

Regulation Type: Addendum to Regular Notification

Distribution date: 06 September 2017

As was announced in G/SPS/N/JPN/471/Add.1 dated 14 November 2016, the revised Article 45 of "the Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control" will enter into force on 1 November 2017, and raw milk/milk products will be added to the list of items subject to animal health quarantine.   In G/SPS/N/JPN/471/Add.2 dated 16 February 2017, MAFF proposed the draft Animal Health Requirements to set out detailed import conditions including required statements in the health certificate to be applied to raw milk/milk products to be imported into Japan from 1 November 2017(*).   In G/SPS/N/JPN/471/Add.3 dated 1 May 2017, MAFF proposed the adopted Animal Health Requirements for raw milk/milk products to be exported to Japan and the model format of the health certificate.   This is to notify Indonesia is added on Listed countries of the Annex of the adopted Animal Health Requirements as attached: http://members.wto.org/crnattachments/2017/SPS/JPN/17_3945_00_e.pdf   (*) Note: Raw milk/milk products arriving in Japan on and after 1 November 2017, including products exported from exporting countries before 1 November 2017, will need to be accompanied by the health certificate issued by the competent authority of the exporting country in accordance with the AHRs.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017

The notified Ministerial Resolution prohibits the use throughout national territory of ethion-based veterinary products, such as anti-fly, anti-larval, anti-mange, anti-lice and anti-tick products, as pour-ons or for environmental application. The use of ethion is permitted exclusively in anti-tick products administered by dipping or spraying.

Products Covered: Veterinary products containing ethion

Regulation Type: Regular notification

Distribution date: 05 September 2017 | Final date for Comment: 03 November 2017

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Pyraclostrobin.

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) - 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, 07.06, 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: 09.01, 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, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)                           

Regulation Type: Regular notification