Top International News in Chemical Policy and Regulation- December 2017: Americas and Asia
Argentine Ministry Of Health Severely Restricts Malathion In The Country: On November 24, 2017, the Argentine Ministry of Health (MOH) notified the World Trade Organization of its promulgation of Resolution 2158-E /2017 (Resolution 2158-E), which effectively restricted the import, production, and use of malathion in the country. Specifically, Article 1 prohibits the import into Argentina of malathion (Chemical Abstracts Service (CAS) No. 121-75-5), in “any presentation, as [a] therapeutic agent for the control of human diseases”, while Article 2 directs “the importation is forbidden in all the territory... [for the purpose of] marketing and use of the malathion product for vector control of importance to public health.” Those entities which presently have the substance in Argentina should take particular note of Article 4, which instructs the “agencies in charge of pesticide deposits [registration and management] for public health use to identify … pesticide products containing malathion in its formulation to be disposed of finally as hazardous waste ….”
Resolution 2158-E specifically cites the facts that the United States Environmental Protection Agency (EPA) has suspended the registration of products based on malathion for residential use, that MERCOSUR (Mercado Común del Sur) has established a technical regulation for sanitizing and disinfectant products (here: pesticides) (MERCOSUR / GMC / RESOLUTION No. 18/10) which prohibits the import and/or use of mutagenic substances in its member states, and that the International Agency for Research on Cancer (IARC) has incorporated malathion in group 2A for non-Hodgkin lymphomas and prostate cancer, as well determining that malathion induces genetic and chromosomal damage in humans and behaves as a hormone disruptor.
Brazil Publishes Reports Regarding Comments On Draft Chemicals Bill: The National Chemical Safety Commission (CONASQ) recently published two reports listing the hundreds of comments received on the 2016 draft bill establishing a chemical regulatory scheme that would include a registry of chemical production and imports; a risk assessment process; and a risk management program authorized to regulate chemicals and impose use restrictions. CONASQ began reviewing the comments in summer 2017. In July 2017, it divided the comments into four categories: matters of law; matters of regulation; out of scope; and other issues. The first report lists almost 700 comments received on matters of law. The second report lists comments that fall into the other three categories. A CONASQ spokesperson stated that CONASQ’s responses to matters of law will be published only when it has concluded discussing the entire report.
Chile Issues Draft Regulation Regarding Classification, Labeling, and Notification of Chemical Substances and Mixtures: On November 13, 2017, the Chilean Ministerio de Salud (Ministry of Health) issued its Draft Reglamento de Clasificación, Etiquetado y Notificación de Sustancias Químicas y Mezclas (Regulations on the classification, labelling and notification of chemical substances and mixtures; Draft Regulation).
The Draft Regulation, among other aspects, implements the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) in Chile, while informing the population about the dangers of chemical substances and mixtures via a variety of hazard communication methods. In addition, the Draft Regulation attempts to prevent misleading practices and negative effects that could arise from the intrinsic hazards of chemical substances.
Comments are due to the Ministerio de Salud by January 12, 2018.
Report On National Action Plan For Chemicals Expected In 2018: As reported in our August 4, 2017, Global Regulatory Update, in April 2017, the Ministry of Environment, Forest, and Climate Change formed the National Coordination Committee to prepare a National Action Plan for Chemicals under the World Bank-aided Capacity Building for Industrial Pollution Management Project being implemented by the Ministry. An action plan for chemicals that are produced, imported, and consumed in India may include:
A policy framework, particularly where registration of chemicals is needed;
Phasing out chemicals over a short- or long-term period based on safety to human health and the environment;
Creating an infrastructure to analyze chemicals and their derivatives and effects on users; and
Revisions to existing legislation; and
India’s involvement in international programs and agreements.
After holding a series of meetings with industry in June 2017, the National Coordination Committee is preparing a report that will provide recommendations and priorities for action. The draft report is expected by January 2018, and the final report by March 2018. It will be discussed at a national-level stakeholder workshop that will include industry associations, government agencies, and NGOs.
Paraguay Drafts Resolution for Outdated Phytosanitary Products Management: The Paraguayan Servicio Nacional de Calidad y Sanidad Vegetal y de Semillas (National Plant and Seed Quality and Health Service, SENAVE) has issued a Proyecto de Resolución (draft resolution) that addresses the management of various outdated substances used in the agricultural industry. The draft, titled "Por la cual se Reglamenta la extensión de fecha de validez; retiro de circulación del mercado y disposición final de productos fitosanitarios, fertilizantes, enmiendas y afines con fecha vencida" (“Regulating the extension of the validity date, the market recall and final disposal of outdated phytosanitary products, fertilizers, soil conditioners and related substances”; Draft Resolution), was issued on October 26, 2017, and manages the items specified in its title.
Specifically, the Draft Resolution (which interestingly does not contain an Artículo (Article) 3 – rather it proceeds from Artículo 2 to Artículo 4) speaks to a variety of steps to be taken once the entitled products reach the end of their defined shelf lives. Among these are: SENAVE has the authority to order the withdrawal of such expired products from the marketplace (Artículo 4), all commercial entities which have such expired products must store them properly in authorized warehouses and inform SENAVE within 60 days of the expiration(s) (Artículo 6) and directing specific methods of disposal (Artículo 12). The Draft Regulation does provide, in certain circumstances, however, the ability for the entities to have “extending the validity date” (Artículo 9). In such instances, SENAVE may grant an extension of one calendar year from the date an “Extension Certificate” is issued, provided an application requesting such is made, and that analytical test results support that the product is still efficacious (Artículo 9). Products for which the extension is granted must bear a SENAVE-supplied sticker (Artículo 10).
Paraguay Issues Draft Resolution Regarding Technical Grade Active Substances: On November 3, 2017, SENAVE issued a Proyecto de Resolución "Por la cual se modifica la resolución N° 446/06 en lo referente a la Categoría de Exportación; se establecen nuevos lineamientos para el Registro de sustancias Activas grado Técnico en esta categoría; y se implementa un Sistema de Control Interno" ("Amending Resolution No. 446/06 on the export category; establishing new guidelines for the registration of technical grade active substances in this category; and implementing an internal control system"; Draft Resolution).
As the name suggests, the Draft Resolution amends Resolution No. 446 of 2006, implemented by Resolution No. 371 of 2007 ("Regulations For The Registration And Enabling Of Means Of Transport Of Active Ingredients And Pesticides Formulated For Agricultural Use Of The National Service Of Quality And Plant Health And Seeds (SENAVE)”), that established the requirements for the registration of new agrochemicals in the country. Among the key aspects of the Draft Regulation are:
Artículo 3: Permits the registration of foreign (produced) active substances, provided that various criteria (e.g., the provision of a registration certificate from the foreign competent authority, toxicological information a safety (data) sheet, and so forth);
Artículo 4: Implements an Internal Control System for traceability between the active substance technical grade product and the formulated product;
Artículo 9: Establishes a time frame (up to 10 days after the import of the active substance that the entity desiring registration must submit the required documentation to SENAVE (including a Certificate of Analysis, analytical methodology and so forth); and
Artículo 14: Requires that phytosanitary products managed under this Draft Resolution must bear a sticker containing codes which “lead to electronic information within the SENAVE database,” which may also be accessible to the public.
Comments were due December 3, 2017.
Ministries Advise Companies To Self-Report TCCA And CCA Violations: In a November 21, 2017, announcement, the Ministry of the Environment (MOE) and Ministry of Justice (MOJ) urged companies to seek penalty exemptions for failing to comply with the notification requirements and other rules under the Chemicals Control Act (CCA) and the earlier Toxic Chemicals Control Act (TCCA) by voluntarily reporting their violations. MOE and MOJ encourage companies to come forward if they have failed to submit:
A confirmation letter for chemical substances;
A declaration of toxic chemical substances imported; or
A declaration of manufacturing/import of observational substances.
Companies are encouraged to report if they failed to obtain:
Permission for importing restricted substances;
Permission for manufacture, import, or sales of prohibited substances; or
A business license for handling hazardous chemical substances.
Companies will be exempt from penalties if they report before the May 21, 2018, deadline. Cases that are currently under investigation or prosecution will be considered for lesser penalties. Penalty exemptions will not apply to a situation where an accident was caused as a result of a breach of the legislation. Reports are due May 21, 2018.