Category: Biotechnology/Synthetic Biology

September 1, 2022

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

 On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics such as what microorganisms are regulated, permit...
September 1, 2022

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

By Lynn L. Bergeson and Carla N. Hutton   On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: “Questions & Answers -- Working with Microorganisms Developed Using Genetic Engineering Under 7 CFR part 340”: The questions and answers (Q&A) cover topics...
July 12, 2022

Register Now for “TSCA New Approach Methodologies”

The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better...
July 6, 2022

Register Now for “TSCA New Approach Methodologies”

Wednesday, August 3, 202212:00 p.m. - 1:00 p.m. (EDT)Register Today The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace...
May 18, 2022

Proposed Rule Concerning CBI Claims under TSCA Addresses EPA Review of Confidentiality Claims and Related Revisions to Other TSCA Rules

As reported in our May 17, 2022, memorandum, on May 12, 2022, the U.S. Environmental Protection Agency (EPA) proposed new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA in 2016 included many new...
May 9, 2022

Register Now For “Domestic Chemical Regulation And Achieving Circularity” – May 18, 2022, From 12:00

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful lives. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and...
April 28, 2022

Register Now for “Domestic Chemical Regulation and Achieving Circularity”

Wednesday, May 18, 202212:00 p.m. - 1:00 p.m. (EDT)Register Today A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a...
April 28, 2022

Register Now for “Domestic Chemical Regulation and Achieving Circularity”

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable...
April 4, 2022

Register Now for “Domestic Chemical Regulation and Achieving Circularity”

Wednesday, May 18, 202212:00 p.m. - 1:00 p.m. (EDT)Register Today A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a...
February 22, 2022

Canadian Government Introduces Bill Intended to Modernize CEPA

Environment and Climate Change Canada (ECCC) announced on February 9, 2022, that the government introduced in the Senate the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), intended to modernize the Canadian Environmental Protection Act, 1999 (CEPA) and make related amendments to the Food and Drugs Act (FDA). The bill was initially introduced in the 43rd Parliament in April 2021 as Bill C-28, but it was not considered due to the federal election...