Memoranda

On November 15, 2011, the Congressional Nanotechnology Caucus will host a briefing on the impact of nanotechnology on job creation. Topics to be addressed include the best ways to encourage private/public partnerships; what kind of jobs nanotechnology investment can create; and where private capital is investing money in nanotechnology. Guest speakers will include: Robert D. "Skip" Rung, President and Executive Director, Oregon Nanoscience and Microtechnologies Institute;  Doug Jamison,...

The Nanotechnology Industries Association (NIA) will hold a workshop on November 30, 2011, entitled "Defining Nano!? Compliance Requirements & Market Impact of the EU Definition of 'Nanomaterials.'" The workshop, which will be held in Brussels, Belgium, is intended to answer questions such as which market sectors will be affected by additional regulatory compliance, the economic impact on current and future applications of nanotechnologies, how the European Union (EU) definition will be...

On November 17, 2011, the Senate Environment and Public Works Committee and the Committee's Superfund, Toxics, and Environmental Health Subcommittee will hold a hearing on legislation intended to reform the Toxic Substances Control Act (TSCA), the Safe Chemicals Act of 2011 (S. 847). Senator Frank Lautenberg (D-NJ), who introduced the legislation on April 14, 2011, and is Chair of the Subcommittee, will chair the hearing. The Safe Chemicals Act is intended to modernize TSCA...

On November 8, 2011, CropLife America and the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) Pesticides, Chemical Regulation, and Right-to-Know Committee convened a program entitled "What's New, What's Hot in Pesticide Law and Policy." Rosemarie Kelley, Director of the U.S. Environmental Protection Agency's (EPA) Office of Civil Enforcement's Waste and Chemical Enforcement Division, gave a presentation concerning EPA's pesticide enforcement priorities....

On October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an "informal draft" Safer Consumer Products Regulations (SCPR). DTSC proposed these regulations after ten months of meetings following the California Secretary for Environmental Protection's instructions to DTSC to stop working on issuing proposed regulations and instead "take additional time to be responsive to the concerns raised and revisit the proposed regulations." Memoranda providing background...

The National Toxicology Program (NTP) published an October 31, 2011, Federal Register notice inviting written comments on its proposed Report on Carcinogens (RoC) review process and announcing a public listening session to receive oral comments. 76 Fed. Reg. 67200. The RoC is a Congressionally mandated, biennial document that identifies agents, substances, mixtures, or exposure circumstances that may pose a hazard to human health by virtue of their...

The U.S. Environmental Protection Agency (EPA) Science Advisory Board (SAB) recently posted a list of fiscal year (FY) 2012 initiatives intended to enhance public involvement in advisory activities. According to the SAB website, in response to suggestions received at a June 1, 2011, session on public involvement, the SAB Staff Office developed additional practices to enhance public involvement in activities of the SAB, Clean Air Scientific Advisory Committee (CASAC),...

On October 25, 2011, Office of Chemical Safety and Pollution Prevention (OCSPP) Assistant Administrator Stephen A. Owens announced his resignation from the U.S. Environmental Protection Agency (EPA). In his message to EPA staff, Mr. Owens stated: I am writing to tell you that, after more than two years of working closely with all of you to protect Americans' health and environment, I have made the difficult decision to leave EPA. My last day in the office will be November 30, 2011.As many of you...

The October 21, 2011, Federal Register includes two test rules concerning high production volume (HPV) chemicals: a final test rule for certain chemicals from the third group, and a proposed test rule and proposed significant new use rule (SNUR) for the fourth group of chemicals. See 76 Fed. Reg. 65385 and 65580, respectively. The proposed "SNUR plus test rule" represents a novel approach for the U.S. Environmental Protection Agency (EPA) in handling HPV...

On October 20, 2011, the National Nanotechnology Initiative (NNI) released its 2011 Environmental, Health, and Safety Research Strategy (Strategy), which is intended to provide guidance to the federal agencies that produce scientific information for risk management, regulatory decision-making, product use, research planning, and public outreach. The Strategy lists the following core research areas providing this information: (1) nanomaterial measurement infrastructure; (2)...

The European Commission (EC) adopted on October 18, 2011, a Recommendation on the definition of a nanomaterial. The Recommendation "invites" member states, European Union agencies, and economic operators to use the following definition of nanomaterial "in the adoption and implementation of legislation and policy and research programmes concerning products of nanotechnologies": "Nanomaterial" means a natural, incidental or manufactured material containing particles, in an unbound state or as an...

On October 6, 2011, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on "Chemical Risk Assessment: What Works for Jobs and the Economy?" According to the background memorandum, the hearing was intended to explore the U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS), and the relationship between IRIS and EPA's regulatory requirements, "specifically whether IRIS is producing high quality science-based risk assessments...

On September 28, 2011, the U.S. Environmental Protection Agency (EPA) issued its final guidance on the weight-of-evidence (WoE) (Final WoE Guidance) analysis that it will use to evaluate the results of data submitted in response to test orders issued for Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP). This WoE analysis, in turn, will be used to determine what substances merit further study under Tier 2 as substances that have the potential to interact with the estrogen,...

The House Energy and Commerce Subcommittee on Environment and the Economy will hold a hearing on October 6, 2011, on "Chemical Risk Assessment: What Works for Jobs and the Economy?" The hearing will begin at 9:00 a.m. The witness list is not yet publicly available. We understand the U.S. Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) process will be a subject of discussion....

On September 19-20, 2011, the Pesticide Operations Management (POM) Working Committee (WC) of the State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research & Evaluation Group (SFIREG) met in U.S. Environmental Protection Agency (EPA) offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and the Association of American Pesticide Control Officials (AAPCO) created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and...

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SEPTEMBER 15, 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 complimentary webinar on the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule on Thursday, September 15, 2011, from 1:30 p.m. to 3:30 p.m. (EDT). This webinar will provide an overview of the new...

Embracing new social media tools, the U.S. Environmental Protection Agency (EPA) on August 18, 2011, invited stakeholders to provide feedback on its new approach for identifying priority chemicals for review and assessment under the Toxic Substances Control Act (TSCA). Noting that EPA's online discussion forum will remain open until 5:00 p.m. (EDT) on September 14, 2011, EPA invited public input on its "Discussion Guide: Background and Discussion Questions for Identifying...

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...

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...

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 in research, while facilitating...

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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 exposure or to...

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 the overall...

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 90 days before commencing that...

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": Harm the normal development of a fetus or child or cause other developmental toxicity;  Cause cancer, genetic damage, or 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 60 days...

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: Opening Remarks: Vincent Caprio, Executive Director, NanoBusiness Commercialization Association (NanoBCA);  Senator Ron Wyden (D-OR);  Sally Tinkle, Ph.D., Acting Director, National Nanotechnology Coordination Office, Nanoscale Science, Engineering, and Technology...

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 changes in...

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...

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 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 identify...

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" that occur at...

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....

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 concentration rate...

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...

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...

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 the...

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...

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 must notify...

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...

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 clarifications." EPA begins by...

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...