May 15, 2015

Ninth Circuit Issues Decision in Civil Rights Case in Review of California SIP

On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations.  This...
May 14, 2015

TSCA Reform: House Subcommittee Holds Markup of Revised Draft TSCA Bill and Passes Amended Draft

On May 14, 2015, the House Energy and Commerce Subcommittee on Environment and the Economy held a markup of a revised discussion draft of the TSCA Modernization Act of 2015, prepared by Subcommittee Chair John Shimkus (R-IL) and released on May 12, 2015. The May 12, 2015, press release announcing the revised discussion draft and markup emphasizes the bipartisan nature of the bill, which is supported by Shimkus, Subcommittee Ranking Member Paul Tonko (D-NY), Committee Chair...
May 6, 2015

TSCA Reform: Detailed Analysis of Substitute Version of Frank R. Lautenberg Chemical Safety for the 21st Century Act

Background A new version of the Frank R. Lautenberg Chemical Safety for the 21st Century Act was considered for markup by the Senate Environment and Public Works (EPW) Committee on April 28, 2015. The revised version, which we identify here as Lautenberg2, includes changes that appear to be intended to address issues and concerns identified by Senators with the previous version of the bill (Lautenberg1). Our review of Lautenberg1 is available online. We reviewed the...
May 5, 2015

DOT Issues Final Rule Strengthening Tank Car Standards And Operational Controls For High-Hazard Flammable Trains, and Other Recent Transportation Developments

DOT Inspector General To Audit PHMSA Progress In Meeting Congressional Mandates: On May 5, 2015, U.S. Department of Transportation (DOT) announced that its Inspector General (IG) has launched an audit of DOT's Pipeline and Hazardous Materials Safety Administration (PHMSA) at the request of Representative Peter DeFazio (D-OR), Ranking Member of the House Transportation and Infrastructure Committee. In its announcement of the audit, the IG's office stated...
May 4, 2015

FDA Issues Draft Guidance For Assessment Of Drugs With Potential Estrogenic, Androgenic, Or Thyroid Pathway Activity, and Other Recent FDA Developments

FDA Announces GUDID Public Website: On May 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that the data submitted to the Global Unique Device Identification Database (GUDID) are now publicly available. The website, in partnership with the National Library of Medicine, is part of the phase-in for the Unique Device Identification compliance timeline and offers anyone access to search or download...
May 1, 2015

Global Regulatory Update for May 2015

AUSTRALIA Australia Publishes Thirteenth Tranche Of IMAP Assessments: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published for public comment the thirteenth tranche of human health and environmental assessments for chemicals identified as part of the Stage One implementation of the Inventory Multi-tiered Assessment and Prioritization (IMAP) Framework. NICNAS states that it seeks comments on information...
April 30, 2015

Jim Aidala Quoted in BNA Daily Environment Report Article “EPA Pushes Back Against IG Criticism Of Pesticide Inspections in North Dakota”

The April 30, 2015, Bloomberg BNA Daily Environment Report discussed correspondence between the U.S. Environmental Protection Agency (EPA) and its inspector general over the value of pesticide inspections.  The article quoted James V. Aidala. Tempest in a Teapot Jim Aidala, a senior consultant at the firm  Bergeson  and Campbell and the former head of what is now the EPA's Office of Chemical Safety and Pollution Prevention, described...
April 29, 2015

TSCA Reform: Senate Committee Holds Markup and Passes Bipartisan Substitute Bill

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider several bills, including the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Prior to the hearing, on April 27, 2015, Senators Tom Udall (D-NM), Sheldon Whitehouse (D-RI), Jeff Merkley (D-OR), and Cory Booker (D-NJ) announced a bipartisan compromise agreement intended to strengthen protections under S. 697, while expanding states' authority. During the...
April 23, 2015

Lynn L. Bergeson to Participate in Key Upcoming Nanotechnology Meetings and Conferences

Earlier this month, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its long-awaited Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale (see our memoranda EPA Proposes Reporting and Recordkeeping Requirements for Nanoscale Materials and EPA Opens Docket for Proposed TSCA...
April 22, 2015

EU Trade Negotiation Tracker Keeps You on Top of TTIP

EPPA, The Acta Group's (Acta®) strategic partner in Brussels, has developed a powerful interactive business tool delivering comprehensive, constantly-updated news, data, documentation, and analysis on European Union (EU) trade negotiations, with a special focus on the ongoing Transatlantic Trade Investment Partnership (TTIP) negotiations between the EU and the U.S. The EU Trade Negotiation Tracker (Tracker), a joint initiative of EPPA and Deloitte, is available on a subscription...