Memoranda

On April 16, 2010, the European Chemicals Agency (ECHA) published a list of substances that companies intend to register under the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation by the November 30, 2010, deadline. The list is based on feedback received from companies and registrations already submitted via the authorized channels. One reason that this exercise is likely being undertaken now by ECHA is to enable ECHA to identify...

Companies located in European Union (EU) countries have expressed relief at news that they may have won more time to comply with a significant new chemicals control law adopted by the Turkish government. This memorandum explains why. Meeting of Interested Parties A delegation of EU chemicals manufacturers and exporters organized by the European Chemical Industry Council (CEFIC) visited the Turkish Ministry of Environment and Forestry (MOEF) in February to ask for more time to comply...

In a March 2010 fact sheet, the U.S. Environmental Protection Agency (EPA) describes how to determine whether a cleaning product is a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, pesticide products must be registered if they are considered to be intended for a pesticidal purpose. EPA states that products are considered to be for a pesticidal purpose “if the person who distributes or sells them claims, states or implies that...

More than 30 years have passed since the U.S. Environmental Protection Agency (EPA) issued its initial set of regulations on the use and distribution in commerce of polychlorinated biphenyls (PCBs) and PCB items. Now with three decades of experience and information on PCBs and PCB items, EPA has decided to exercise its authority under the Toxic Substances Control Act (TSCA) and reassess the regulations governing PCB use authorizations and distribution in commerce. On April 7,...

On March 29, 2010, the U.S. Environmental Protection Agency (EPA) announced its action plan on bisphenol A (BPA). In its press release, EPA states that the BPA action plan “focuses on the environmental impacts of BPA and will look to add BPA to EPA’s list of chemicals of concern and require testing related to environmental effects.” EPA notes that, in January 2010, the Food and Drug Administration (FDA) announced that it had some concerns about...

On March 17, 2010, the U.S. Environmental Protection Agency (EPA) announced that it is preparing action plans for nonylphenol/nonylphenol ethoxylate (NP/NPE), hexabromocyclododecane (HBCD), siloxanes, and diisocyanates. EPA is also preparing final action plans for the chemicals remaining on EPA’s initial list — bisphenol A and benzidine dyes. EPA chose the chemicals based on a range of criteria, including identification as persistent, bioaccumulative, and toxic; high production...

On March 10, 2010, the European Chemicals Agency (ECHA) Board of Appeals (Board) issued a document, Practice Directions to Parties to Appeal Proceedings Before the Board of Appeal of the European Chemicals Agency (Practice Directions), to provide guidance on various aspects of the appeals proceedings, including communications with the Board, procedures for lodging a notice of appeal and other pleading documents, the rights of parties to confidentiality, and procedures for parties...

On December 30, 2009, the Chinese Ministry of Environmental Protection (MEP) adopted the newly amended new chemical notification scheme “Measures on Environmental Management of New Chemical Substances” (新化学物质环境管理办法), Order 7. The new program enters into force on October 15, 2010. This memorandum provides a general overview of this critically important new program. Background The new regulation is intended in part to align China with other leading regulatory...

On March 5, 2010, the U.S. Government Accountability Office (GAO) released a report entitled Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). The Federal Food, Drug, and Cosmetic Act (FFDCA) exempts generally recognized as safe (GRAS) substances, which include spices, artificial flavors, emulsifiers and binders, vitamins and minerals, and preservatives, from the general requirement that companies obtain Food and Drug...

On March 9, 2010, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled “Business Perspectives on Reforming U.S. Chemical Safety Laws.” Senator Frank R. Lautenberg (D-NJ), Chair of the Subcommittee, convened the hearing with leaders of businesses that manufacture or use chemicals to examine their business perspectives on reforming the Toxic Substances Control Act (TSCA). Only two other Senators...

Today the U.S. Department of Transportation’s Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a final rule narrowing the list of hazardous materials (hazmats) that require security plans when transported in commerce. 75 Fed. Reg. 10974. The rule is effective on October 1, 2010, although voluntary compliance is authorized as of April 8, 2010. The final rule also revises the regulations applicable to the content of and training associated with security...

Today the European Chemicals Agency (ECHA) proposed to identify eight chemicals as substances of very high concern (SVHC) and possible candidates for authorization under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. The detailed proposals are available on the ECHA website online. Comments are due April 22, 2010. Potential Additions to the SVHC Listing Denmark, France, and Germany proposed identifying eight substances as SVHCs. ECHA...

On March 4, 2010, the House Committee on Energy and Commerce Subcommittee on Commerce, Trade, and Consumer Protection held a hearing entitled “TSCA and Persistent, Bioaccumulative, and Toxic Chemicals: Examining Domestic and International Actions.” The Subcommittee held the hearing to examine U.S. and international efforts to protect public health and the environment from persistent, bioaccumulative, and toxic (PBT) chemicals, how the Toxic Substances Control Act (TSCA) is currently...

On March 1, 2010, Health Canada began a public consultation on its adoption of the Interim Policy Statement on Health Canada’s Working Definition for Nanomaterials (Interim Policy). Although Health Canada is accepting comments, it states that the Interim Policy “is effective immediately.” In preparing the Interim Policy, Health Canada states that it sought the informal feedback of some international stakeholders, industry trade groups, standards associations, and...

On February 25, 2010, the House Committee on Energy and Commerce Subcommittee on Energy and Environment held a hearing entitled “Endocrine Disrupting Chemicals in Drinking Water: Risks to Human Health and the Environment.” The Subcommittee intended the hearing to examine the science and regulation of endocrine disruptors that may be found in sources of drinking water. Witnesses included: The witness testimony is available online. Subcommittee members criticized the slow pace of...

Today the U.S. Environmental Protection Agency (EPA) published its final clarification under which certain activated phosphors that are not on the Toxic Substances Control Act (TSCA) Section 8(b) Chemical Substance Inventory (TSCA Inventory) will be considered to be “new” chemical substances under TSCA Section 5, and thus will be subject to applicable notification requirements under TSCA Section 5. According to EPA, the clarification is necessary because EPA’s statements in...

On February 18, 2010, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released a report entitled EPA Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities, urging EPA to coordinate better risk assessment and oversight activities by establishing a management plan that contains new goals and measures that demonstrate the results of Office of Pollution Prevention and Toxics (OPPT) and Office of Enforcement and Compliance...

On February 19, 2010, the U.S. Environmental Protection Agency (EPA) proposed important revisions to the procedures for development of enforceable consent agreements (ECA) to generate test data under Section 4 of the Toxic Substances Control Act (TSCA). 75 Fed. Reg. 7428 (Feb. 19, 2010). The proposed rule includes some sweeping changes for when and how negotiations will be initiated, conducted, and concluded, and limits the timeframe within which these activities will take place. Companies that...

In a February 18, 2010, Politics Daily article, Lynn L. Bergeson commented on regulations being developed by the U.S. Environmental Protection Agency (EPA) that would increase reporting of nanomaterial products. Bergeson stated that she expects EPA to propose that businesses provide data only for new products, and that those on the market would be grandfathered in....

The U.S. Environmental Protection Agency (EPA) Scientific Advisory Panel (SAP) has released the minutes of its November 3-5, 2009, meeting regarding evaluation of the hazard and exposure associated with nanosilver and other nanometal pesticide products. Before summarizing the SAP’s primary conclusions and recommendations, we note a few general observations. First, the SAP final recommendations address nanosilver almost entirely, and little or no mention is made of “nanometal...