Memoranda

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...

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...

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 on May 19, 2011, to provide practical guidelines...

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 —...

March 1, 2011, is the deadline for owners or operators of facilities covered under Section 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA) to file annual “Tier II” reporting forms to the appropriate state and local agencies. Under EPCRA Section 312, any facility required under Occupational Safety and Health Administration (OSHA) regulations to maintain material safety data sheets (MSDS) for hazardous chemicals and that stores these chemicals on-site during the...

On February 10, 2011, during a hearing on “Regulatory Impediments to Job Creation,” the House Committee on Oversight and Government Reform released a preliminary staff report entitled Assessing Regulatory Impediments to Job Creation. In December 2010, Committee Chair Darrell Issa (R-CA) sent letters to over 150 businesses, industry organizations, and think tanks asking for examples of existing and proposed regulations that have negatively impacted job growth, as well as...

Both Turkey and South Korea are working to implement chemical management programs to comply with broader international initiatives. In December 2009, Turkey implemented new legislation concerning the classification, labeling, and packaging (CLP) of dangerous substances and preparations, and a regulation on safety data sheets (SDS) for dangerous substances and preparations. South Korea has initiated a process for the management of chemicals, with the objective of minimizing the harmful effects...

On February 3, 2011, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled “Assessing the Effectiveness of U.S. Chemical Safety Laws.” Subcommittee Chair Frank Lautenberg (D-NJ) last year introduced the Safe Chemicals Act of 2010, a bill that would have reformed the Toxic Substances Control Act (TSCA) by shifting the burden of proof to industry to show chemicals are safe, rather than the U.S....

On January 18, 2011, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a proposed rule that would revise EPA’s February 6, 2006, final rule concerning protections for subjects in human research. According to EPA, the proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The proposed amendments would also disallow participation in third-party pesticide...

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) published on January 19, 2011, a “plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.” See FDA News Release, “FDA to improve most common review path for medical devices” (Jan. 19, 2011), available online. That path is the Premarket Notification, or 510(k) process, used for the bulk of...

On January 7, 2011, the U.S. Consumer Product Safety Commission (CPSC) announced that it will hold two live web conferences on the publicly available consumer product safety information database. During the first web conference, scheduled for January 11, 2011, CPSC will demonstrate key functions of the database, such as how a consumer will be able to use the new online reporting form to submit a report of harm related to the use of a consumer product...

The Acta Group, L.L.C.’s (Acta) thoughts are below on what may be headed our way in 2011 from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). In short, the general trends established by the Obama Administration during the past two years are expected to continue notwithstanding the 2010 election results. At the same time, the impact of the election results, notably with the new Republican majority in the House...

The California Department of Toxic Substances Control (DTSC) released a December 23, 2010, letter from Linda S. Adams, California’s Secretary for Environmental Protection to Assembly Member Mike Feuer, the author of the 2008 law (A.B. 1879) that would require regulations to address chemicals and chemical ingredients in consumer products. In the letter, Secretary Adams responded to Feuer’s letter outlining his concerns about the DTSC’s November 16, 2010, release of revisions to...

On December 6-7, 2010, the State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research & Evaluation Group (SFIREG) held its semi-annual full committee meeting at the U.S. Environmental Protection Agency’s (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 cooperation between the...

On December 17, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) issued proposed regulations that would specify hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (CDTSC) will develop. CDTSC will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of...

Korea has taken a major step toward achieving full compliance with the United Nations Globally Harmonized System (GHS) for the classification and labeling of chemicals by identifying 151 substances as “hazardous” for consultation. The Ministry of the Environment (MoE) in Korea also is placing more responsibilities on manufacturers and importers by introducing new rules regarding updating and content of material safety data sheets (MSDS). The MoE has given companies just ten days to...

On December 9, 2010, the U.S. Consumer Product Safety Commission (CPSC) promulgated the final rule establishing a publicly available consumer product safety information database, as required by Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The database must be publicly available, searchable, and accessible through CPSC’s website. CPSC’s final rule interprets various statutory requirements pertaining to the information to include in the database, and...

The U.S. Environmental Protection Agency (EPA) will announce in a Federal Register notice scheduled for publication on December 13, 2010, that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the studies as part of an ongoing...

Monday, December 20, 20101:30 p.m. – 3:30 p.m. (EST) Bergeson & Campbell, P.C. (B&C) is hosting a free webinar on endocrine disruptors on December 20, 2010. This webinar will provide an introduction to the issues associated with endocrine disruptors and testing strategies under the U.S. Environmental Protection Agency’s (EPA) Endocrine Disruptor Screening Program (EDSP), while focusing on recent EPA developments that expand the regulatory scope beyond pesticide...

SAVE THE DATE January 27, 20111:00 – 5:30 p.m. (EST) NANO GOVERNANCE: THE CURRENT STATE OF FEDERAL, STATE, AND INTERNATIONAL REGULATION Please mark January 27, 2011, on your calendar for an exciting teleconference under development by the American Bar Association, Section of Environment, Energy, and Resources, Pesticides, Chemical Regulation, and Right-to-Know Committee. Program Overview: More details to follow....