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Top International News in Chemical Policy and Regulation- April 25, 2017: Americas and Asia

AUSTRALIA

NICNAS Requests Information About Products In The Trade Name Annex Of The AICS: On March 7, 2017, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published a Chemical Gazette notice requesting information about products in the Trade Name Annex of the Australian Inventory of Chemical Substances (AICS). For each industrial chemical making up a trade name product listed in the Trade Name Annex as of March 7, 2017, the following information on the chemical identity is required:

  • Chemical Abstracts Service (CAS) name;

  • CAS number; and

  • Molecular formula.

Where a product’s name has changed and differs from that in the Trade Name Annex, but the product has the same chemical ingredients as the listed product, NICNAS asks that companies provide the chemical composition of the rebranded product and details of when the product was rebranded. Any such chemical may, on application to NICNAS, be included in the confidential section of the AICS if certain criteria are met. Once NICNAS receives the requested information, it will add the particulars of the industrial chemical(s) making up a trade name product that is not already on the AICS to the AICS, and then remove the trade name product. Responses are due March 9, 2018. If NICNAS does not receive information about each chemical making up a trade name product by the due date, NICNAS must remove the trade name product from the AICS.

Australia Publishes 20th Tranche of IMAP Assessments: NICNAS published for public comment the 20th tranche of human health and environmental assessments for chemicals identified as part of the Inventory Multi-tiered Assessment and Prioritization (IMAP) Framework. NICNAS states that it seeks comments where information that has the potential to affect the outcome of an assessment has not been considered. The 20th tranche assessments include excluded use chemicals. In Stage Two of IMAP, NICNAS is screening the AICS for chemicals that are used exclusively for therapeutic, agricultural, veterinary, or food purposes (excluded uses). NICNAS states that it does not consider excluded use chemicals to be relevant industrial chemicals, and they do not need Tier II assessment. According to NICNAS, this is part of preparatory (pre-prioritization) work to identify criteria for the identification of higher risk chemicals requiring assessment. Comments on the 20th tranche of assessments should be evidence-based and the relevance of submitted information should be highlighted. Comments are due May 12, 2017.

BRAZIL

Brazil Proposes Additional Requirements For Hazardous Waste Management: Brazil’s Lower House of its Congress, the Câmara dos Deputados (Chamber of Deputies), has proposed legislation (the Bill) that would strengthen the requirements contained in its existing hazardous waste-related law, the Política Nacional de Resíduos Sólidos (National Solid Waste Policy, No. 12.305/2010), which has been in effect since 2010. If passed by both houses of Congress and signed into national law, the Bill, which is not presently available online, would mandate that hazardous waste operators install tracking devices, that could be accessed remotely, on vehicles used to transport hazardous waste throughout the country. Furthermore, the Bill includes a provision that would mandate the National Registry of Hazardous Waste Operators to develop a process that would be capable of remotely tracking hazardous waste at all points in its lifecycle, from generation to storage to transport and ultimately to disposal.

CANADA

 Mandatory Surveys Concerning Certain Substances Require Information For Risk Management: On April 1, 2017, Canada published in the Canada Gazette two Canadian Environmental Protection Act, 1999 (CEPA) Section 71 notices to obtain information for the risk management of approximately 80 substances. Canada states that it needs information from manufacturers, importers, and users of these substances to identify current commercial data, such as quantities and applications of these substances in Canadian commerce. Canada staggered the information gathering initiative through two separate notices with staggered reporting timelines. The Summer 2017 survey applies to approximately 21 substances that are toxic or proposed to be toxic as defined under CEPA Section 64:

  • Part 1 -- Hexavalent chromium compounds;

  • Part 2 -- 2-Propanone, Reaction Products with Diphenylamine (PREPOD) and related substance;

  • Part 3 -- Dechlorane plus (DP), decabromodiphenyl ethane (DBDPE), and decabromodiphenyl ether (decaBDE); and

  • Part 4 -- Refractory ceramic fibers.

Every person to whom the notice for Summer 2017 applies is required to comply no later than June 28, 2017, 3:00 p.m. (ET). The Fall 2017 notice applies to 50 substances that are toxic as defined under CEPA Section 64:

  • Part 1 -- Toluene diisocyanates;

  • Part 2 -- Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- (DTBSBP);

  • Part 3 -- 2,4,6-tri-tert-butylphenol (2,4,6-TTBP);

  • Part 4 -- Bis(2-ethylhexyl) phthalate; and

  • Part 5 -- Tetrachloroethylene (PERC), trichloroethylene (TCE), and nonylphenol and its ethoxylates. 

Every person to whom the Notice for Fall 2017 applies is required to comply no later than September 27, 2017, 3:00 p.m. (ET). Guidance is available for companies to help determine if they are subject to the notice and for assistance with completing the sections of the notice. According to the guidance, mixtures and products that may contain reportable substances include, but are not limited to:

  • Prepared formulations;

  • Homogenous and heterogeneous alloys;

  • Hydrates;

  • Reaction mixtures that are characterized in terms of their constituents;

  • Brake fluids;

  • Fuels;

  • Lubricants;

  • Paints and coatings;

  • Ink toners and colorants;

  • Cosmetics and personal care products (e.g., lipstick, mascara, toothpaste, mouthwash, creams, and lotions);

  • Cleaning liquids, gels, or sprays; and

  • Adhesives and glues.

CHINA

 China Publishes The Final Version Of The New Regulation On Pesticide Administration: On April 1, 2017, the State Council of China published Decree Number 677 of the State Council of China (China Decree 677), the final version of the new “Regulation on Pesticide Administration (RPA),” which will become effective on June 1, 2017.

The first version of RPA became effective on May 8, 1997, and was revised by China Decree 326, which took effect on November 29, 2001. China Decree 677 includes the following eight chapters -- General Provisions, Pesticide Registration, Production of Pesticides, Distribution of Pesticides, Uses of Pesticides, Supervision and Management, Legal Liability, and Supplementary Provision -- and has significant changes to the current version of RPA (China Decree 326). The key changes in the new RPA are as follows:

  • Streamline the administration process:

    • Pesticides will now be administered by the Ministry of Agriculture (MOA), instead of multiple ministries.

    • Licensing systems for pesticide production and distribution will be implemented.

    • Promote the reduction of pesticide uses and enhance the management of highly toxic pesticides.

  • Clarify the responsibilities:

    • Manufacturers, sponsors of the contracted manufacturers, and distributors are responsible for the safety, efficacy, and quality of pesticides.

  • Prevent and punish adulteration of pesticides and enhance enforcement:

    • Increased fines and blacklisting are included to strengthen the punishments for adulteration.

  • Revise the registration process:

    • Temporary pesticide registration is no longer an option. The MOA will formulate the relevant rules and measures for the pesticide registration and establish the Pesticide Registration Review Committee, but no timeline is provided.

    • The review times for pesticide registration are included. The MOA should complete its review within 40 working days for the notification of field trials of new pesticides after receiving accepted notification application. The provincial department of agriculture should submit its preliminary review recommendations to the MOA within 20 working days after receiving accepted pesticide registration application of domestic products and the MOA should complete its review within 20 working days after receiving preliminary review recommendations from the provincial department of agriculture. The registration of overseas pesticide products will be directly submitted to the MOA by applicant.

    • Registration holder is allowed to transfer its data used for the registration but not the registration certificate to others.

    • Exemption of residue and environmental tests is allowed to register pesticides with the same composition as well as the same application scopes and methods as a registered pesticide, but authorization by the registration holder is required for the registered pesticide within the six-year protection period from the date of registration.

  • Revise pesticide labeling requirements:

    • All pesticide labels must be approved by the MOA.

    • False or misleading labeling is not allowed.

    • Changes to approved label content are not allowed without approval by the MOA.

  • Improve the recording and tracking system of pesticide uses:

    • Manufacturers and distributors/retailers of pesticides must maintain the required records for at least two years.

    • Overseas enterprises cannot distribute or sell pesticides in China directly and will have to distribute or sell pesticides through either their own distribution entity in China or pesticide distribution agents in China.

  • Establish the pesticide recall and pesticide waste recycling systems:

    • Manufacturers are responsible for recalling timely pesticides deemed to have serious toxicity or great risk.

    • Promote the recycling of pesticide wastes by manufacturers and distributors/retailers. The Ministry of Environmental Protection (MEP), MOA, the Ministry of Finance, and the relevant ministries will formulate the relevant rules and measures for its implementation, but no timeline is included.

VIETNAM

Vietnam Updates Draft Existing Chemicals Inventory: Vietnam Updates Draft Existing Chemicals Inventory: The Ministry of Industry and Trade announced on March 13, 2017, the availability of an updated draft existing chemicals inventory. The draft inventory includes 4,927 substances, an increase from the 3,300 on the draft inventory published in September 2016. Once a final inventory is published, substances not listed will be considered new chemicals. According to the announcement, Vietnam continues to accept comments and nominations of additional chemicals.

© 2017 The Acta Group All Rights ReservedNational Law Review, Volume VII, Number 115

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