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Showing 6 posts in Biotechnology. View our practice description for Biotechnology.

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology.  The first document, a proposed update to the 1986 framework, intends to clarify the current roles of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) – the three primary agencies involved in the regulation of biotechnology products.  Members of the regulated industry, other stakeholders, and members of the broader public may submit comments on the proposed update until November 1, 2016.  The second document presents a national strategy outlining future steps that the Agencies intend to take to ensure that the regulatory system addresses novel biotechnology product types going forward.  As directed by the Executive Office of the President last year, the Agencies have also commissioned development of a third document by the National Academies of Sciences, Engineering and Medicine (NAS) to address future biotechnology products and opportunities to enhance capabilities of the regulatory system.  The NAS expects to release its report at the end of 2016.  Read More ›

First-Ever Federal Labeling Requirements for Bioengineered Foods Signed Into Law

On July 29, President Obama signed into law a bill establishing first-ever federal requirements for the labeling of food containing genetically engineered ingredients.  The bill, known as S.764, directs the U.S. Department of Agriculture (USDA) to issue rules to establish mandatory labeling requirements for so-called “bioengineered foods.”  In preparing its new regulations, USDA must determine the threshold levels of a bioengineered substance that will subject a food to the labeling requirements and develop a process for manufacturers and others to obtain a determination from the Agency concerning the status of a given food item under the new program. USDA must issue these rules within the next two years, and food manufacturers, technology developers, and other interested parties are expected to have opportunities to submit comments throughout the rulemaking process. Read More ›

USDA Declares “Do-Over” on Overhaul of Biotechnology Regulations

The U.S. Department of Agriculture’s (“USDA”) Animal and Plant Health Information Service (“APHIS”) is renewing efforts to amend or replace its existing rules governing plant-based biotechnology, while highlighting possible changes to its regulations that may significantly expand the scope of biotechnology products and processes subject to APHIS jurisdiction.  Akin to an advance notice of proposed rulemaking, APHIS’s Notice of Intent seeks public input on scoping for a Programmatic Environmental Impact Statement (“PEIS”) under the National Environmental Policy Act (“NEPA”).  APHIS’s non-exclusive proposals range from status quo to transformative, and its notice provides a rare opportunity for agriculture and biotechnology stakeholders to help shape what may become a wholly new regulatory program to replace APHIS’s three-decades-old regulations at 7 C.F.R. Part 340.  Comments are due by March 7, 2016. Read More ›

APHIS Withdraws 2008 Proposal to Amend Regulation of GE Organisms

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2015 that it is officially withdrawing a six year-old proposal that originally sought to substantially amend the agency’s decades-old regulatory program governing the introduction of certain genetically engineered (GE) organisms into the environment.  The 2008 proposal, among other key changes, would have expanded the scope of GE organisms subject to APHIS regulation while establishing a new and comprehensive permitting system to replace APHIS’ current notification and permitting procedures.  It now has been formally withdrawn so that APHIS can “begin fresh stakeholder engagement aimed at exploring alternative policy approaches.”  A brief overview of APHIS’ withdrawal action follows. Read More ›

Court Victory for Genetically Engineered Crop

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service and the agriculture-biotechnology industry received welcome news on January 5, 2012.   Read More ›

TCEQ Seeks Public Comment on Penalty Policy Revisions

TCEQ has proposed revisions to the agency’s Penalty Policy that would increase statutorily authorized penalties, cap the penalty enhancement attributable to compliance history to implement the provisions of TCEQ’s Sunset Bill and other legislative enactments and provide that all avoided cost returns earned by respondents (with the exception of political subdivisions and non-profit organizations) will be included in the total assessed penalty. Read More ›