September 3, 2015

Bergeson & Campbell, P.C. Quoted in Inside EPA Article “New EPA Guide Aims To Improve Synthetic Biology Algae Project Reviews”

A September 3, 2015, Inside EPA article regarding EPA’s efforts to improve how it reviews companies’ proposals to develop synthetic biology products, and specifically biotech algae, featured quotes from Bergeson & Campbell, P.C.: In a recent memo to clients, the law firm Bergeson & Campbell calls the announcement of the algae guide update "hugely important for the industrial biotechnology communities," adding that "EPA's announcement suggests a broader Agency...
September 1, 2015

Global Regulatory Update for September 2015

CHINA Guidance On The Catalog Of Hazardous Chemicals Includes Mandatory GHS Classifications: On August 19, 2015, the State Administration of Work Safety (SAWS) released guidance on the Catalog of Hazardous Chemicals. The guidance includes mandatory Globally Harmonized System of Classification and Labeling of Chemicals (GHS) classifications for all 2,828 listed chemicals. It also provides instructions on how to determine if a mixture is...
August 25, 2015

EPA Schedules Workshop on Considerations for Risk Assessment of Biotechnology Algae

The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the...
August 3, 2015

EPA Posts Information on Biotechnology Algae Project

The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology.  EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches.  EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae...
July 31, 2015

Lynn L. Bergeson Quoted in BNA Daily Environment Report Article “Companies Invited to Help Develop Algae Guidance”

The July 31, 2015, Bloomberg BNA Daily Environment Report spoke with Lynn L. Bergeson regarding EPA’s plans to develop updated guidance for companies making chemicals with genetically engineered microorganisms under the Toxic Substances Control Act (TSCA). “EPA's posting of the synbio algae project is hugely important for the industrial biotechnology and synthetic biology communities,” Lynn  Bergeson, managing partner of Bergeson  & Campbell P.C., told...
July 27, 2015

HCS:  OSHA Issues Inspection Procedures for Hazard Communication Standard (HCS 2012)

On July 20, 2015, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) issued OSHA Directive Number CPL 02-02-079. The Directive is intended to establish "policies and procedures to ensure uniform enforcement of the Hazard Communication standard" (HCS 2012). The Directive repeals previous instructions CPL 02-02-038 and CPL 02-02-039. It also cancels both enforcement memorandums effective February 9, 2015, and May 29, 2015, respectively. For more...
July 10, 2015

Endocrine Disruptors:  EPA Releases Endocrine Disruptor Screening Program Tier 1 Assessments

The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant benchmark in the program since the original List 1 test orders were initially issued in October 2009. Fifteen of the original 67 List 1 chemicals were subsequently cancelled or discontinued by the respective pesticide registrants. The intended purpose of the Tier 1 screening was to identify potential...
July 9, 2015

TSCA Reform:  House Passes TSCA Modernization Act:  Senate to Consider TSCA Soon

On June 23, 2015, the House passed the TSCA Modernization Act of 2015 (H.R. 2576) by a vote of 398-1. The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill "would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee." According to the press release, support "has poured in for this bill as it works to improve the protection of human health and...
July 6, 2015

Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of...
July 1, 2015

China Publishes Revised New Chemical Notification and Registration Guidance for Public Comment

After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the "Guidance for New Chemical Substance Notification and Registration (Draft)" (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (guidance@mepscc.cn). In addition, MEP-SCC will hold a...