Archive for September, 2016
On September 15, 2016, the White House posted a blog unveiling two documents as part of the Administration’s continuing effort to modernize the federal regulatory system for biotechnology products . These two documents also clarify various roles of the Environmental Protection Agency, Food and Drug Administration and Department of Agriculture in evaluating new biotechnologies.
These two documents are:
- Proposed Update to the Coordinated Framework for the Regulation of Biotechnologyto clarify current roles and responsibilities, open public comment.
- National Strategy for Modernizing the Regulatory System for Biotechnology Products to set forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.
EPA has published the following notice:
“The U.S. Environmental Protection Agency has revised the emerging viral pathogens guidance for the claims that can be made for EPA-registered disinfectant products intended to combat emerging viral pathogens. This document provides general guidance that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens. The revisions to the guidance are in response to input received by the agency. The guidance outlines an expedited process for registrants to provide useful information to the public on effective products.