February 5, 2016

Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Organisms

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to “prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.” The notice...
February 4, 2016

REACH Enforcement: Notes from ANSI Chemical Network Presentation

On January 21, 2016, the American National Standards Institute (ANSI) hosted a presentation on enforcement under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. The topics covered included “Enforcement — the Actors and the Activities”; “[the European Chemicals Agency (ECHA) Forum for Exchange of Information on Enforcement (ECHA Forum)]’s Role and Initiatives”; “Enforcement Targeted to...
February 3, 2016

EPA Seeks Comment on Draft Guidelines for Human Exposure Assessment

On January 7, 2016, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register the beginning of a 45-day comment period on the peer review draft of the Guidelines for Human Exposure Assessment (draft Guidelines). According to EPA, the draft Guidelines benefit from over two decades of experience with assessments conducted by EPA programs under their respective authorities and constraints, as well as from input from external panels, including the...
February 2, 2016

OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products.” The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas. The third public meeting...
January 7, 2016

FDA Issues Final Rule Amending Food Additive Regulations

On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances (FCS) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. All three of the FCSs contain extended perfluorinated alkyl chains greater than or equal to eight carbons in length and as such are long-chain...
January 5, 2016

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2016

Click here for a PDF version of the memorandum. Even if Toxic Substances Control Act (TSCA) legislation is not enacted, 2016 will be a momentous year. As the curtain closes on eight years of the Obama Administration, there are a number of items expected to be among the “legacy” issues in the chemical and pesticide regulation space. Enhanced protections for farmworkers, more protective assessment policies, and a re-energized toxic chemical assessment program are among the...
December 22, 2015

TSCA Reform: Detailed Summary of Key Changes in Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as Compared with S. 697 Passed by Senate EPW in June

This analysis reviews the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as passed by the Senate on December 17, 2015, and compares it to the previous version of S. 697 (identified as Lautenberg2 in this analysis), passed by the Senate Environment and Public Works (EPW) Committee in June 2015. This review also briefly compares S. 697 to H.R. 2576, the [Toxic Substances Control Act (TSCA)] Modernization Act of 2015, which passed the...
December 17, 2015

Congressional Negotiators Reach Deal on LWCF Reauthorization and Include Language Concerning Labeling Guidelines for GE Salmon

On December 16, 2015, the House Appropriations Committee released the Consolidated Appropriations Act, 2016. The 2,009-page bill includes full appropriations legislation and funding for the 12 annual appropriations bills through the end of fiscal year (FY) 2016. The bill would reauthorize the Land and Water Conservation Fund (LWCF), which expired on September 30, 2015. This reauthorization is likely what prompted Senator Richard Burr (R-NC) to inform Senate Majority Leader Mitch...
December 14, 2015

HCS: OSHA Issues Letter of Interpretation on Import/Export Labels for Hazard Communication Standard (HCS 2012)

On November 23, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued a Letter of Interpretation (LOI) on labeling packages for import and export. The LOI discusses labeling scenarios and details OSHA’s interpretation of the Hazard Communication Standard (HCS 2012) requirements for those scenarios. Background On May 26, 2012, OSHA issued a final rule modifying its HCS to conform to the United Nations’ Globally Harmonized...
December 11, 2015

Proposition 65:  OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important “clear and reasonable warnings” requirements under Proposition 65 (Prop 65); and (2) it replaced it with a new proposed rule that will repeal and replace the Prop 65 Article 6 regulations (Proposed Rule),...