Memoranda

The Office of the U.S. Trade Representative (USTR) and the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) issued a May 19, 2011, memorandum to U.S. departments and agencies to highlight the importance of regulatory transparency and openness to promoting international trade. The memorandum is important as it telegraphs the growing importance of trade considerations in domestic regulatory issues, and the Administration’s renewed emphasis on...

According to a Federal Register notice scheduled for publication in the May 11, 2011, Federal Register, the U.S. Environmental Protection Agency (EPA) is amending the Toxic Substances Control Act (TSCA) Section 8(a) Inventory Update Reporting (IUR) regulations by suspending the next IUR submission period, which would otherwise run from June 1, 2011, to September 30, 2011. The IUR requires manufacturers, including importers, of certain chemical substances included on the...

On May 6, 2011, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT), which was the subject of premanufacture notice (PMN) P-08-199. Under the final SNUR, persons intending to manufacture, import, or process MWCNT for a use that is designated as a significant new use by the final rule...

In an important and little noticed May 3, 2011, Federal Register notice, the U.S. Department of Commerce International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the European Union (EU) that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports. Of critical importance, the ITA plainly recognizes and acknowledges that the main impediments to...

EPA states: “The Office of Pesticide Programs (OPP) initiated and recently completed an internal review of the use of conditional registrations. The review looked at the variability in the use of the term “conditional registration” in the program, how the internal computer coding associated with conditional registrations has been applied, the status of actions that have been characterized as conditional registrations, and the potential for improvements and...

MAY 9, 2011 — SAVE THE DATE Bergeson & Campbell, P.C. (B&C), B&C Consortia Management, L.L.C. (BCCM), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that B&C will host a webinar to discuss Senator Frank Lautenberg’s (D-NJ) recently reintroduced bill to amend the Toxic Substances Control Act (TSCA), the Safe Chemicals Act of 2011, on Monday, May 9, 2011, from 1:00 p.m. to 3:00 p.m. (EDT). This...

On April 14, 2011, Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011, which is intended to modernize the Toxic Substances Control Act (TSCA) to require chemical companies to demonstrate the safety of industrial chemicals and the U.S. Environmental Protection Agency (EPA) to evaluate safety based on the best available science. The bill is co-sponsored by Senators Amy Klobuchar (D-MN), Charles Schumer (D-NY), and Barbara Boxer (D-CA). Lautenberg previously introduced...

The U.S. Environmental Protection Agency (EPA) released on April 13, 2011, chemical action plans for methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI), and related compounds. According to EPA, Americans may be exposed to these chemicals when they are used in certain applications, such as spray foam insulation, sealing concrete, or finishing floors. EPA states that diisocyanates are used to make polyurethane polymers. Most polyurethane products, such as foam mattresses or bowling...

The European Chemicals Agency (ECHA) announced on April 13, 2011, that it has updated REACH-IT to allow the submission of notifications for substances in articles. Beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import that were included on the substances of very high concern (SVHC) Candidate List before December 1, 2010, if both of the following conditions are met: ECHA states that, to explain the actual submission process,...

Three Subcommittees of the Green Ribbon Science Panel (Panel) have scheduled several teleconferences between April 4 and April 19, 2011, to discuss potential revisions to the California Department of Toxic Substances Control’s (DTSC) Safer Consumer Product Alternatives (SCPA) regulations. These teleconferences are open to the public and comments may be provided. The three Subcommittees and the scheduled teleconferences are as follows: As noted, the teleconferences are open to the...

On April 1, 2011, the European Chemicals Agency (ECHA) announced the availability of an update to the Guidance on Requirements for Substances in Articles. The update replaces the previous Guidance. Beginning June 1, 2011, companies must notify to ECHA substances present in articles they produce or import that were included on the substances of very high concern (SVHC) Candidate List before December 1, 2010, if both of the following conditions are met:...

Two of the trade associations named as negotiators by the U.S. Food and Drug Administration (FDA) regarding its proposal for the imposition of generic drug user fees have filed comments regarding the proposal that may frame their negotiating posture with the Agency going forward. The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceutical Task Force and the European Chemical Industry Council’s (CEFIC) Fine Chemicals Group urged FDA to impose a registration fee...

On March 29, 2011, the U.S. Senate Committee on Environment and Public Works held a hearing entitled “Oversight Hearing on Disease Clusters and Environmental Health.” Committee Chair Barbara Boxer (D-CA) and Senator Mike Crapo (R-ID), Ranking Member of the Superfund, Toxics, and Environmental Health Subcommittee, introduced the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76), also known as Trevor’s Law, on January 25, 2011. The bill...

On March 30 and 31, 2011, the Center for Food Safety and Applied Nutrition (CFSAN) of the U.S. Food and Drug Administration (FDA) will hold a Food Advisory Committee meeting on the possible link between synthetic dyes in food products and behavioral issues in children, such as attention deficit hyperactivity disorder (ADHD). Members of the Food Advisory Committee have been charged to “consider available relevant data on the possible association between consumption of certified color...

Now that the number of substances included on the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Candidate List is up to 47 and counting, it is important to pay closer attention to requirements pertaining to substances of very high concern (SVHC). Article 7 of REACH requires producers, importers, and suppliers of articles to notify the European Chemicals Agency (ECHA) of the presence in articles of SVHCs that have been on the Candidate...

Effective April 18, 2011, Jim Willis, Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) Chemical Control Division (CCD), will join the United Nations Environment Programme (UNEP) as the Executive Secretary of the Basel, Stockholm, and Rotterdam Conventions. Willis has been with EPA for more than 20 years in various staff through senior management positions. He also worked with UNEP for a number of years before returning to...

On March 12, 2011, China’s State Administration of Work Safety (SAWS) issued Decree 591, “Regulation on the Safe Management of Dangerous Chemicals,” which concerns the safe use of chemicals. The regulation is very wide ranging in scope and “sets the tone” for future chemicals legislation. As one of the more immediate impacts, State Decree 591 uses the National Standards GB 13690-2009 on the general rules for the classification and hazard communication of chemicals,...

Last month, the U.S. Environmental Protection Agency (EPA) updated its table listing the sunset dates of chemicals subject to final Toxic Substances Control Act (TSCA) Section 4 and related Section 12(b) actions. The table lists, in ascending Chemical Abstracts Service (CAS) Registry Number order, all chemical substances and mixtures that are and/or have been the subject of final TSCA Section 4 test rules and/or TSCA Section 4 enforceable consent agreements/orders (ECA) issued by EPA under...

On March 11, 2011, the U.S. Consumer Product Safety Commission (CPSC) announced the availability of the SaferProducts.gov database mandated by Congress, as part of the Consumer Product Safety Improvement Act. CPSC encourages consumers to visit www.SaferProducts.gov to submit reports of harm or risks of harm, and to search for safety information on products they own or may be considering buying. According to CPSC, reporting product safety incidents through the site will help CPSC...

On March 4, 2011, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed to list four chemicals as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65) under the “Labor Code mechanism” for listing contained in Health and Safety Code Section 25249.8(a). The four substances are: Chemical CAS No. Endpoint Reference Cyclopenta[cd]pyrene 27208-37-3 Cancer (2010a; 2010b) Ethanol in alcoholic beverages —...