Memoranda

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 EPA in...

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...

Thank you for participating in Bergeson & Campbell, P.C.’s webinar on endocrine disruptors Monday, December 20, 2010. We are delighted that you were able to participate, and hope that you found the information and format useful and convenient. Request the materials from this webinar....

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...