Memoranda

The Organization for Economic Cooperation and Development (OECD) recently released three documents on pesticide minor uses: (1) Guidance Document on Regulatory Incentives for the Registration of Pesticide Minor Uses (Minor Use Guidance); (2) OECD Survey on Regulatory Incentives for the Registration of Pesticide Minor Uses: Survey Results; and (3) OECD Survey on Efficacy & Crop Safety Data Requirements & Guidelines for the Registration of Pesticide Minor Uses: Survey...

The Congressional Research Service (CRS) has released two reports concerning the Toxic Substances Control Act (TSCA) — a February 23, 2011, report entitled “The Toxic Substances Control Act (TSCA): A Summary of the Act and Its Major Requirements,” and a July 25, 2011, report entitled “Proposed Reform of the Toxic Substances Control Act (TSCA) in the 112th Congress: S. 847 Compared with Current Law.” Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals...

On July 26, 2011, the Office of the Secretary of the Department of Health and Human Services (HHS), in coordination with the Office of Science and Technology Policy (OSTP), issued an advance notice of proposed rulemaking (ANPR) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. The ANPR seeks comment on how to protect better human subjects who are involved...

The U.S. Environmental Protection Agency (EPA) is currently scheduled to publish on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). EPA will request comments on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA will also seek comments on requiring environmental testing consisting of sampling and monitoring for BPA...

The Green Ribbon Science Panel (Panel) met on July 14-15, 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. Under AB 1879 and Health and Safety Code (HSC) 25253, DTSC is required to adopt regulations “that establish a process for evaluating chemicals of concern in consumer products, and their potential alternatives, to determine how best to limit...

On July 14, 2011, the House Science, Space, and Technology Subcommittee on Investigations and Oversight held a hearing on the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program. According to the hearing charter, the hearing was prompted in part by the recent National Academy of Sciences (NAS) report on EPA’s formaldehyde assessment, which focused on the process EPA uses to develop initially draft IRIS assessments and which is separate from...

On July, 14, 2011, the Senate Committee on Commerce, Science, and Transportation’s Science and Space Subcommittee held a hearing on national nanotechnology investment. The hearing was held to examine the potential of nanotechnology, federal initiatives to coordinate research investments, barriers to commercialization, possible environmental and health risks, and steps Congress can take to improve the return on federal nanotechnology investments as the Committee works on drafting a...

On July 11, 2011, the U.S. Environmental Protection Agency (EPA) announced a proposed significant new use rule (SNUR) for 14 glymes, a class of chemicals structurally related to glycol ethers. According to EPA, the proposed rule, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), would require persons who intend to manufacture, import, or process the glymes for an activity that is designated as a significant new use to notify EPA at least...

On June 30, 2011, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a proposed rule seeking to narrow certain recycling exemptions under the Resource Conservation and Recovery Act’s (RCRA) “Definition of Solid Waste” (DSW) provisions. The rule should be published in the Federal Register within the next two weeks. A pre-publication copy of the rule and related information can be accessed online. EPA will accept comments on the rule for...

The European Chemicals Agency (ECHA) has sent to the Partner Expert Group (PEG) a draft of a second version of the guidance on data sharing for phase-in and non-phase-in substances under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) (Data Sharing Guidance). The first edition of the Data Sharing Guidance was published in 2007. ECHA has revised the entire Data Sharing Guidance document, including correcting mistakes and inconsistencies, proposing to remove...

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...