Memoranda

The U.S. Environmental Protection Agency (EPA) released on August 2, 2011, the pre-publication copy of the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The rule was published on August 16, 2011. 76 Fed. Reg. 50816. Bergeson & Campbell, P.C. will host a webinar on the CDR Rule in mid to late September and will provide under separate cover webinar registration details....

The U.S. Environmental Protection Agency (EPA) announced on August 2, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The CDR is intended to enable EPA to collect and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures on the TSCA Chemical Substance Inventory (TSCA Inventory). This includes current information on...

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...

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...

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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 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 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 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 July 1, 2010, the Minnesota Department of Health (MDH) released its list of “chemicals of high concern.” Under the 2009 Toxic Free Kids Act, a “chemical of high concern” is a chemical “identified on the basis of credible scientific evidence by a state, federal, or international agency as being known or suspected with a high degree of probability to”: The Act instructs MDH to “consider chemicals listed as a suspected carcinogen, reproductive...

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. Please note that the location has been corrected....

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...

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...

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...