Memoranda

Taiwan is likely to publish a draft national inventory of existing chemical substances by the end of 2011. During an interagency meeting held the week of June 20, 2011, participants chose to delay publication of the draft inventory to align it with legislation for new chemicals notification. Taiwan will introduce new chemicals notification by amending two laws — the Labor Safety and Health Act (LSHA), managed by the Council of Labor Affairs, and the Toxic Chemical...

The Nanotechnology Caucus will hold a lecture entitled “Nanotechnology 101” on June 22, 2011, at 11:00 a.m. (EDT) in Room 253 of the Russell Senate Office Building. The agenda includes: Lynn L. Bergeson is Chair of the NanoBCA Environment, Health, and Safety Committee and worked closely with Senator Wyden’s staff in organizing the meeting. To RSVP, please contact Vincent Caprio at vincent@nanobca.org....

On June 14, 2011, the U.S. Food and Drug Administration (FDA) took long-awaited action to update regulations for testing and labeling over-the-counter (OTC) sunscreen products. The Agency emphasized that the primary intent of its initiative was to establish a consistent standard for testing and labeling sunscreen products to reduce consumer confusion and encourage proper use of these products to enhance their protective function. The most significant elements of FDA’s action include...

Senators Frank Lautenberg (D-NJ), Chair of the Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health, and James Inhofe (R-OK), Ranking Member of the Senate Environment and Public Works Committee, announced that their staffs will co-host on June 21, 2011, the first of several stakeholder meetings concerning reform of the Toxic Substances Control Act (TSCA). Lautenberg introduced the Safe Chemicals Act of 2011 (S. 847), which is intended to modernize TSCA to...

On June 9, 2011, the Food and Drug Administration (FDA or the Agency) posted on its home page a Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology. The Agency states that this document is the first step in providing regulatory clarity about the use of nanomaterials in FDA-regulated products and other more product-specific guidance documents are likely to follow. Specifically, the Draft Guidance is “intended to help industry and others...

The U.S. Environmental Protection Agency (EPA) released on June 9, 2011, a pre-publication copy of a forthcoming Federal Register notice describing several possible approaches for obtaining certain additional information on the composition of pesticide products. EPA focuses particularly on information about what nanoscale materials are present in registered pesticide products, and defines “nanoscale material” as “an active or inert ingredient and any component parts thereof...

On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials”...

On June 6, 2011, the California Court of Appeal for the First Appellate District affirmed the 2009 decision by the Alameda County Superior Court upholding the Office of Environmental Health Hazard Assessment’s (OEHHA) use of the Labor Code mechanism to add chemicals to Proposition 65. California Chamber of Commerce v. Schwarzenegger (Div. 1, No. A125493). This effectively means that the so-called Labor Code mechanism is a viable listing mechanism for Proposition 65 purposes. This...

Under the revised notification process published this month by Japan’s Ministry of Economy, Trade, and Industry (METI), companies exporting to Japan will be better able to protect confidential business information (CBI). Previously, only Japanese entities could notify information on the required substances. The new notification process provides that, if a notifier (manufacturer or importer in Japan) has “extreme difficulties in identifying a certain chemical substance or its...

As of June 1, 2011, notifications for substances of very high concern (SVHC) identified on the Candidate List before December 1, 2010, contained in articles must be performed. The current Candidate List is available online. Thirty-eight substances are impacted by the June 1, 2011, notification deadline with an additional eight substances to be notified by June 15, 2011. The European Chemicals Agency (ECHA) conducted a webinar on May 19, 2011, to provide practical guidelines...

Three Subcommittees of the Green Ribbon Science Panel (Panel) have scheduled several teleconferences between May 31 and June 16, 2011, to discuss potential revisions to the California Department of Toxic Substances Control’s (DTSC) Safer Consumer Product Alternatives (SCPA) regulations, as required by AB 1879. These teleconferences are open to the public and comments may be provided. The Panel had previously convened three Subcommittees to discuss issues related to chemical...

Bergeson & Campbell, P.C. (B&C), The Acta Group, L.L.C. (Acta), and The Acta Group EU, Ltd (Acta EU) are pleased to announce that on June 23, 2011, Lynn L. Bergeson, Lisa R. Burchi, and Leslie S. MacDougall will participate in a webinar entitled “The Evolving REACH Data Citation/Compensation Scheme: What to Watch for and Why.” The European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation is a complex chemical...

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 greater trade...

On April 25, 2011, the U.S. Environmental Protection Agency (EPA) released a website regarding conditional registrations granted under Section 3(c)(7) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The website, entitled “Conditional Registration,” is available online. A related press release is available online. As discussed more below, the new website appears to raise as many questions as it seeks to answer. EPA states: “The Office of Pesticide...

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,...