How the Federal Government Regulates Biotech Plants
The Federal government has a coordinated, risk-based system to ensure that new biotechnology products are safe for the environment and human and animal health. Established as a formal policy in 1986, the Coordinated Framework for Regulation of Biotechnology (PDF, 479KB) describes the Federal system for evaluating products developed using modern biotechnology. The Coordinated Framework is based upon existing laws designed to protect public health and the environment. The U.S. government has written new regulations, policies, and guidance to apply these laws to biotechnology-derived products.
The U.S. Government agencies responsible for oversight of the products of agricultural modern biotechnology are the USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). Depending on its characteristics, a product may be subject to the jurisdiction of one or more of these agencies. Regulatory officials from the three agencies regularly communicate and exchange information to ensure that any safety or regulatory issues that may arise are appropriately resolved.
Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting agriculture from pests and diseases. Under the Plant Protection Act, USDA-APHIS has regulatory oversight over products of modern biotechnology that could pose such a risk. Accordingly, USDA-APHIS regulates organisms and products that are known or suspected to be plant pests or to pose a plant pest risk, including those that have been altered or produced through genetic engineering. These are called "regulated articles." USDA-APHIS regulates the import, handling, interstate movement, and release into the environment of regulated organisms that are products of biotechnology, including organisms undergoing confined experimental use or field trials. Regulated articles are reviewed to ensure that, under the proposed conditions of use, they do not present a plant pest risk through ensuring appropriate handling, confinement and disposal.
USDA-APHIS regulations provide a petition process for the determination of non regulated status. If a petition is granted, that organism will no longer be considered a "regulated article" and will no longer be subject to oversight by USDA-APHIS. The petitioner must supply information such as the biology of the recipient plant, experimental data and publications, genotypic and phenotypic descriptions of the genetically engineered organism, and field test reports. The agency evaluates a variety of issues including the potential for plant pest risk; disease and pest susceptibilities; the expression of gene products, new enzymes, or changes to plant metabolism; weediness and impact on sexually compatible plants; agricultural or cultivation practices; effects on non-target organisms; and the potential for gene transfer to other types of organisms. A notice is filed in the Federal Register and public comments are considered on the environmental assessment and determination written for the decision on granting the petition. Copies of the USDA-APHIS documents are available to the public.
For more information, visit: http://www.aphis.usda.gov/aphis/ourfocus/biotechnology
The EPA through a registration process regulates the sale, distribution and use of pesticides in order to protect health, and the environment, regardless of how the pesticide was made or its mode of action. This includes regulation of those pesticides that are produced by an organism through techniques of modern biotechnology. The Biopesticides and Pollution Prevention Division of the Office of Pesticide Programs, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), regulates the distribution, sale, use and testing of pesticidal substances produced in plants and microbes. Generally, Experimental Use Permits are issued for field testing. Applicants must register pesticidal products prior to their sale and distribution, and the EPA may establish conditions for use as part of the registration. The EPA also sets tolerance limits for residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug and Cosmetic Act.
For more information, visit: http://www.epa.gov/pesticides/biopesticides
The FDA is responsible for ensuring the safety and proper labeling of all plant-derived food and feed, including those developed through genetic engineering. All food and feed, whether imported or domestic and whether derived from crops modified by conventional breeding techniques or by genetic engineering techniques, must meet the same rigorous safety standards. Under the Federal Food, Drug, and Cosmetic Act, it is the responsibility of food and feed manufacturers to ensure that the products they market are safe and properly labeled. In addition, any food additive, including one introduced into food or feed by way of plant breeding, must receive FDA approval before marketing. (The term "food additive" refers to substances introduced into food that are not pesticides and are not generally recognized as safe by qualified scientific experts.)
The FDA ensures that food and feed manufacturers meet their obligations through its enforcement authority under the Federal Food, Drug, and Cosmetic Act. To help sponsors of food and feed derived from genetically engineered crops meet their legal obligations, the FDA encourages manufacturers to participate in its voluntary consultation process. Developers routinely consult with FDA prior to marketing. The goal of the consultation process is to ensure that human food and animal feed safety issues or other regulatory issues are resolved prior to commercial distribution.
For more information, visit: http://www.fda.gov/Food/IngredientsPackagingLabeling/GEPlants/default.htm
Read the rest here:
Regulation of Biotech Plants | USDA
- Angel Biotechnology (ABH) - Video [Last Updated On: November 28th, 2011] [Originally Added On: November 28th, 2011]
- Curing the entire world through biotechnology [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Biotechnological innovation on Farming Skill [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Growth and development of Biotechnology [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Biotechnology: Boon to Human being [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Philippines banks on biotechnology to deal with enviromentally friendly issues, food security considerations [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Philippines banks on biotechnology to deal with enviromentally friendly issues, food security considerations [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Biotechnology: Boon to Human being [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Growth and development of Biotechnology [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Biotechnological innovation on Farming Skill [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Curing the entire world through biotechnology [Last Updated On: December 18th, 2011] [Originally Added On: December 18th, 2011]
- Scientists make ethical stem cells from skin of a rat [Last Updated On: January 22nd, 2012] [Originally Added On: January 22nd, 2012]
- India emerging as a global hub for stem cell research [Last Updated On: January 22nd, 2012] [Originally Added On: January 22nd, 2012]
- India emerging as a global hub for stem cell research [Last Updated On: January 22nd, 2012] [Originally Added On: January 22nd, 2012]
- Scientists make ethical stem cells from skin of a rat [Last Updated On: January 22nd, 2012] [Originally Added On: January 22nd, 2012]
- Alzheimer Disease - New Drugs, Markets and Companies [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- Amazing Stem Cell Therapy Results | Before [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- Stemcell therapy for pets - Mi Mascota - Video [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- Stem cells for dogs? New pain management therapy works for pets - Video [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- Riot's Lameness Moving Exam Pre Stem Cell Therapy - Video [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- Riot's Lameness Palpation Exam Pre Stem Cell Therapy - Video [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- Ariel's Stem Cell Miracle! - Video [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- South Korea again gives a go ahead to use of human eggs in cloning research [Last Updated On: February 5th, 2012] [Originally Added On: February 5th, 2012]
- South Korea again gives a go ahead to use of human eggs in cloning research [Last Updated On: February 5th, 2012] [Originally Added On: February 5th, 2012]
- Angel Biotechnology - Contracts with Materia Medica [Last Updated On: February 7th, 2012] [Originally Added On: February 7th, 2012]
- Cellerant Therapeutics Appoints Lowell E. Sears to Board of Directors [Last Updated On: February 21st, 2012] [Originally Added On: February 21st, 2012]
- Angel Biotechnology - Grant of Share Options [Last Updated On: February 27th, 2012] [Originally Added On: February 27th, 2012]
- RBCC Closes Deal with Game Changing Biotech Firm [Last Updated On: March 16th, 2012] [Originally Added On: March 16th, 2012]
- The year of the dragon looks auspicious for Australian Biotechnology [Last Updated On: March 25th, 2012] [Originally Added On: March 25th, 2012]
- The year of the dragon looks auspicious for Australian Biotechnology [Last Updated On: March 25th, 2012] [Originally Added On: March 25th, 2012]
- David Allan Lauded for Leadership – Biotechnology Leader Named to Industry Award [Last Updated On: May 9th, 2012] [Originally Added On: May 9th, 2012]
- Angel Biotechnology - Angel signs new contract with ReNeuron [Last Updated On: May 17th, 2012] [Originally Added On: May 17th, 2012]
- MYOS Names Veteran Biotechnology Executive Dr. Sol J. Barer to Chair Scientific Advisory Board [Last Updated On: June 27th, 2012] [Originally Added On: June 27th, 2012]
- StemCells and Keryx Biopharmaceuticals Showing Strong Gains as Biotechnology Industry Soars in 2012 [Last Updated On: July 24th, 2012] [Originally Added On: July 24th, 2012]
- Osiris Therapeutics and Pluristem Therapeutics Showing Impressive Growth as Biotech Industry Thrives in 2012 [Last Updated On: August 4th, 2012] [Originally Added On: August 4th, 2012]
- Allele Biotechnology Announces New Advance in Production of Human Stem Cells [Last Updated On: September 14th, 2012] [Originally Added On: September 14th, 2012]
- BIO Announces Therapeutic Workshops for 11th Annual BIO Investor Forum [Last Updated On: September 25th, 2012] [Originally Added On: September 25th, 2012]
- Biotech Industry Applauds Introduction of the High Technology Small Business Research Incentives Act [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Biotech Industry Look to Benefit From New Act Designed to Promote R&D Joint Ventures [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- David Lichtenstein: Biotechnology is Rich Area for Investment [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Donna Dickenson introduces Bioethics - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Coare Biotechnology and ChemDiv Establish Co-Marketing and Service Collaboration [Last Updated On: November 9th, 2012] [Originally Added On: November 9th, 2012]
- blood banks | Umbilical Cord Blood Banking Could Be an Investment in Our Future Health - Video [Last Updated On: November 12th, 2012] [Originally Added On: November 12th, 2012]
- Research and Markets: Research Report on the Biotechnology Market in India 2012 [Last Updated On: November 18th, 2012] [Originally Added On: November 18th, 2012]
- Life Un(Ltd), Charis Thompson, Three Times a Woman- A Gendered Economy of Stem Cell Innovation Pt. 2 - Video [Last Updated On: November 30th, 2012] [Originally Added On: November 30th, 2012]
- Life UnLtd, Charis Thompson, Three Times a Woman A Gendered Economy of Stem Cell Innovation Pt 1 - Video [Last Updated On: November 30th, 2012] [Originally Added On: November 30th, 2012]
- Biotechnology: Things you should know about Gene Therapy [Last Updated On: December 2nd, 2012] [Originally Added On: December 2nd, 2012]
- Biotechnology: Things you should know about Gene Therapy [Last Updated On: December 2nd, 2012] [Originally Added On: December 2nd, 2012]
- Top trends for Biotechnology [Last Updated On: December 9th, 2012] [Originally Added On: December 9th, 2012]
- Top trends for Biotechnology [Last Updated On: December 9th, 2012] [Originally Added On: December 9th, 2012]
- Angel Biotechnology losses widen [Last Updated On: December 10th, 2012] [Originally Added On: December 10th, 2012]
- Why Biotech ETFs are a Top Sector in 2012 [Last Updated On: December 19th, 2012] [Originally Added On: December 19th, 2012]
- Things to know about the real fountain of youth [Last Updated On: January 11th, 2013] [Originally Added On: January 11th, 2013]
- Things to know about the real fountain of youth [Last Updated On: January 20th, 2013] [Originally Added On: January 20th, 2013]
- DNA testing is Good or Bad: Let’s Discuss [Last Updated On: March 2nd, 2013] [Originally Added On: March 2nd, 2013]
- Computer Review Announces New Tools to Deal with the Flood of Information from the Biotechnology Sector [Last Updated On: March 7th, 2013] [Originally Added On: March 7th, 2013]
- DNA testing is Good or Bad: Let’s Discuss [Last Updated On: March 10th, 2013] [Originally Added On: March 10th, 2013]
- The Mystery about Cyanide Taste [Last Updated On: March 31st, 2013] [Originally Added On: March 31st, 2013]
- The Mystery about Cyanide Taste [Last Updated On: April 14th, 2013] [Originally Added On: April 14th, 2013]
- Are Biodegradable Heart Stents Safe? [Last Updated On: April 17th, 2013] [Originally Added On: April 17th, 2013]
- Piper Jaffray Biotechnology Analyst Participates in Historical Medical Event at the Vatican [Last Updated On: April 17th, 2013] [Originally Added On: April 17th, 2013]
- Are Biodegradable Heart Stents Safe? [Last Updated On: April 21st, 2013] [Originally Added On: April 21st, 2013]
- TaiGen Biotechnology Announces Submission of New Drug Application for Nemonoxacin in Taiwan and Mainland China [Last Updated On: May 17th, 2013] [Originally Added On: May 17th, 2013]
- How good to use home pregnancy tests [Last Updated On: June 1st, 2013] [Originally Added On: June 1st, 2013]
- How good to use home pregnancy tests [Last Updated On: June 2nd, 2013] [Originally Added On: June 2nd, 2013]
- Questions you should ask to doctor for Alzheimer disease [Last Updated On: July 6th, 2013] [Originally Added On: July 6th, 2013]
- Questions you should ask to doctor for Alzheimer disease [Last Updated On: July 7th, 2013] [Originally Added On: July 7th, 2013]
- BetaStem Therapeutics Retains Conditas Biotechnology Group for Business Development and Corporate Strategy [Last Updated On: July 18th, 2013] [Originally Added On: July 18th, 2013]
- Sanguine BioSciences Announces Distribution Partnership with AMS Biotechnology [Last Updated On: August 8th, 2013] [Originally Added On: August 8th, 2013]
- Matric Revision: Life Sciences: Genetics: Biotechnology (5/9): Cloning (1/4) - Video [Last Updated On: October 27th, 2013] [Originally Added On: October 27th, 2013]
- Matric Revision: Life Sciences: Genetics: Biotechnology (6/9): Cloning (2/4) - Video [Last Updated On: October 29th, 2013] [Originally Added On: October 29th, 2013]
- History of biotechnology - Wikipedia, the free encyclopedia [Last Updated On: December 16th, 2013] [Originally Added On: December 16th, 2013]
- Exciting business ideas in biotechnology and healthcare - Video [Last Updated On: February 19th, 2014] [Originally Added On: February 19th, 2014]
- Crippled canines get new leash on life [Last Updated On: March 27th, 2014] [Originally Added On: March 27th, 2014]
- Stem Cell Treatment for Dogs - pet insurance [Last Updated On: March 27th, 2014] [Originally Added On: March 27th, 2014]
- New patenting guidelines needed for biotechnology, experts argue [Last Updated On: April 24th, 2014] [Originally Added On: April 24th, 2014]
- New tumor-targeting agent images and treats wide variety of cancers [Last Updated On: June 24th, 2014] [Originally Added On: June 24th, 2014]
- San Diego Hosts World's Largest Biotechnology Convention - Video [Last Updated On: June 28th, 2014] [Originally Added On: June 28th, 2014]
- Shot in the arm for research on disease biology [Last Updated On: July 13th, 2014] [Originally Added On: July 13th, 2014]
- biotechnology -- Encyclopedia Britannica [Last Updated On: August 28th, 2014] [Originally Added On: August 28th, 2014]