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FDA Issues Draft Guidance For Assessment Of Drugs With Potential Estrogenic, Androgenic, Or Thyroid Pathway Activity, and Other Recent FDA Developments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 information submitted for...
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...
April 20, 2015

DTSC Releases Final Priority Product Work Plan

On April 16, 2015, the California Department of Toxic Substances Control (DTSC) released its much anticipated Final Priority Product Work Plan under the Safer Consumer Products Regulations. The Work Plan, initially proposed on September 12, 2014, describes product categories it will use to evaluate and identify product-chemical combinations to be added to the Priority Products. The purpose of the Work Plan is to provide a “level of predictability to potential manufacturers, importers,...
April 14, 2015

TSCA Reform:  House Subcommittee Holds Hearing on TSCA Modernization Act

On April 14, 2015, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on the discussion draft of the TSCA Modernization Act of 2015 (TMA DD) introduced by Subcommittee Chair John Shimkus (R-IL) on April 7, 2015. As noted in our April 9, 2015, memorandum, “Shimkus Releases Discussion Draft of TSCA Reform Legislation,” in the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then...
April 9, 2015

TSCA Reform:  Shimkus Releases Discussion Draft of TSCA Reform Legislation

On April 7, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a Discussion Draft of the “TSCA Modernization Act of 2015” (TMA DD). In the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a revised discussion draft of the bill, CICA2. In addition, Shimkus held “countless” hearings concerning reform of the Toxic...
April 8, 2015

TSCA:  EPA Opens Docket for Proposed TSCA Section 8(a) Rule for Nanomaterials

The U.S. Environmental Protection Agency’s (EPA) 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 was published in the April 6, 2015, Federal Register. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity,...
April 8, 2015

K-REACH:  List of Priority Existing Substances Submitted for Consultation

On April 1, 2015, the Korean Ministry of Environment submitted the list of priority existing substances for consultation in accordance with Article 9 of Korea’s Registration, Evaluation, Authorization, and Restriction of Chemicals (K-REACH) regulation. The list identifies in Korean and English 518 phase-in (existing) substances that are considered a priority and thus part of the first phase of registration under K-REACH. The deadline for submitting comments is April 30,...
April 6, 2015

TSCA:  EPA Proposes Reporting and Recordkeeping Requirements for Nanoscale Materials

On April 6, 2015, the U.S. Environmental Protection Agency (EPA) issued a Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production volume, methods...
April 5, 2015

House Bill Would Block EPA From Vetoing Dredge And Fill Permits Issued By Army Corps Of Engineers, and Other Recent CWA Developments

House Bill Would Block EPA From Vetoing Dredge And Fill Permits Issued By Army Corps Of Engineers: On March 3, 2015, West Virginia’s entire House of Representatives delegation re-introduced a bill that is intended “to stop the federal Environmental Protection Agency’s unprecedented overreach,” according to the bill’s sponsor, David McKinley (R-WV). The bill (H.R. 1203) would amend the U.S. Environmental Protection Agency’s (EPA) authority to revoke...
April 2, 2015

ECHA Publishes List Of Pending Article 95 Applications and Other Recent BPR Developments

ECHA Publishes List Of Pending Article 95 Applications:The European Chemicals Agency (ECHA) announced in a March 31, 2015 press release, that to increase transparency ahead of the September 1, 2015, deadline for the compliance with Biocidal Products Regulation (BPR) Article 95, it has published a list of all pending Article 95 applications. The list contains applications for which the ECHA has not yet taken a decision, and ECHA will update it regularly. ECHA will synchronize its...