BIOTECHNOLOGY & GENETICS LAW

Biotechnology & Genetics-Related Statutes Federal Food, Drug, and Cosmetic Act (FFDCA) - 21 USC 9 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - 7 USC 136 Federal Plant Pest Act - 7 USC 7B Toxic Substances Control Act (TSCA) - 15 USC 53 Biotechnology & Genetics-Related Regulations EPA Regulations Regulations under FIFRA/FFDCA - 40 CFR Parts 152, 172, 174, 180 Plant-Pesticides, Supplemental Notice; Proposed Rule - Federal Register: May 16, 1997 (Volume 62, Number 95). Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act; Proposed Rule - Federal Register: November 23, 1994 (Volume 59, Number 225). Microbial Pesticides: Experimental Use Permits and Notifications - Federal Register: September 1, 1994 (Volume 59, Number 169). Regulations under TSCA - 40 CFR Part 725 - Reporting Requirements and Review Processes for Microorganisms Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act - Federal Register: April 11, 1997 (Volume 62, Number 70). USDA Regulations 7 CFR 340 - Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests. Simplification of Requirements and Procedures for Genetically Engineered Organisms and Products - Federal Register: May 2, 1997 (Volume 62, Number 85). Genetically Engineered Organisms and Products; Notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status - Federal Register: March 31, 1993 (Volume 58, Number 60). Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests - Federal Register: June 16, 1987 (Volume 52, Number 115). USFDA Regulations Statement of Policy: Foods Derived from New Plant Varieties - Federal Register: May 29, 1992 (Volume 57, Number 104).

MegaLaw Books: Biotechnology Law From Aspen Publishers: » Biotechnology: Law, Business, and Regulation by Michael J. Malinowski. Looseleaf (Dec. 2002) Price: $235.00 From Amazon.com: » Patents for Chemicals, Pharmaceuticals and Biotechnology: Fundamentals of Global Law, Practice and Strategy by Philip Grubb. Hardcover (Apr. 1999) Price: $90.00 » Understanding Biotechnology Law: Protection, Licensing, and Intellectual Property Policies by Gale R. Peterson. Hardcover (May 1993) Price: $195.00 » Body Parts: Propety Rights & the Ownership of Human Biological Materials by E. Richard Gold. Paperback (Mar. 1998) Price: $21.95 » Regulatory Practice for Biopharmaceutical Production by Anthony S. Lubiniecki & Susan A. Vargo (Editors). Hardcover (July 1994) Price: $225.00 » Exploding the Gene Myth : How Genetic Information Is Produced and Manipulated by Scientists, Physicians, Employers, Insurance Companies, Educators, and Law Enforcers by Ruth Hubbard. Paperback (May 1999) Price:$12.25

• Environmental Protection Agency (EPA) - Regulates biotechnology products including microbial/plant pesticides, new uses of existing pesticides, and novel microorganisms.
  • Office of Pesticides Programs — Biopesticides
  • Office of Pollution Prevention and Toxics
  • Plant Pesticide Regulatory Decisions
• U.S. Department of Agriculture (USDA) - Regulates biotechnology products including plant pests, plants, and veterinary biologics.
  • USDA's Agricultural Biotechnology Website
  • Animal and Plant Health Inspection Service (APHIS) - Regulates the movement, importation, and field testing of Genetically Engineered Organisms (GEOs) through permitting and notification procedures.
  • APHIS Veterinary Biologics - Inspects biologics production establishments and licenses genetically engineered products.
  • Food Safety Inspection Service (FSIS) - Responsible for the safe use of engineered domestic livestock, poultry, and products derived from them.
  • Foreign Agricultural Service (FAS) - Monitors foreign regulations and restrictions of GEOs.
  • Agricultural Research Service (ARS) conducts in-house research on GEOs.
  • Economic Research Service (ERS) - Conducts research on the economic impact of GEOs.
  • Cooperative State Research, Education, and Extension Service (CSREES) - Administers the biotechnology risk assessment program as well as research programs in gene mapping, sequencing and biotechnology applications.
  • Agricultural Marketing Service (AMS) - Facilitates the strategic marketing of agricultural products including seed regulatory and testing services and granting of intellectual property rights for certain plant varieties.
  • Grain Inspection, Packers and Stockyards Administration (GIPSA) - Facilitates grain and oilseed marketing by providing quality standards and inspection services.
  • GIPSA Reference Laboratory - Addresses the market's need for standardization and validation of testing methods used commercially for determining if products were derived from biotechnology through its .
• U.S. Food and Drug Administration (FDA) - Regulates biotechnology products including food, feed, food additives, veterinary drugs, human drugs and medical devices.
  • Policy for Foods Developed by Biotechnology

New Trait/Organism	Regulatory Review Conducted by:	Reviewed for:
Viral Resistance in food crop	USDA EPA FDA	Safe to grow Safe for the environment Safe to eat
Herbicide Tolerance in food crop	USDA EPA FDA	Safe to grow New use of companion herbicide Safe to eat
Herbicide Tolerance in ornamental crop	USDA EPA	Safe to grow New use of companion herbicide
Modified Oil content in food crop	USDA FDA	Safe to grow Safe to eat
Modified flower color ornamental crop	USDA	Safe to grow
Modified soil bacteria degrades pollutants	EPA	Safe for the environment

• Ag Biotechnology Patents and New Technologies
• BIOBIN - A Co-operative Resource on Safety in Biotechnology, developed between OECD's BioTrack Online and UNIDO's BINAS.
• Biodatabases.com
• Biodrugtechnology.com/
• BioFind - Proclaims to be the Internet's "one-stop-shop" for world wide Biotechnology industry information, gossip and news.
• BioInfoSeek
• BioInfoSeek Laws & Regulations
• Biosafety Information Network and Advisory Service (BINAS) - A service of the United Nations Industrial Development Organization (UNIDO) that monitors global developments in regulatory issues in biotechnology.
• BioMedNet
• Biotech Browser - Company research and business information tool for the biotechnology industry.
• BiotechCentral - Portal to the biotech industry.
• Biotechnology Industry Organization - Biotechnology information, advocacy and business support.
• Biotechnology: Patenting Issues
• Biotechnology Regulations Throughout the World - from the Biosafety Information Network and Advisory Service.
• Biotechnology Risk Assessment Research Grants Program - USDA Cooperative State Research, Education, and Extension Service, Agricultural Research Service, Updated September 27, 2001.
• BiotechWatch
• BioTrack Online - Focuses on information related to the regulatory oversight of products of biotechnology which is used by governments, industry and other stakeholders.
• BioWorld Online - Worldwide biotechnology news and information source.
• Center for International Development at Harvard University (CID)
  • Aquaculture
  • Innovation Systems
  • Evolution of the Biotechnology Industry
  • Biotechnology and International Trade
  • Biotechnology and Intellectual Property Rights
  • Biotechnology and International Relations
  • Biodiversity and Traditional Knowledge
  • Biotechnology at Harvard
  • Biotechnology in Developing Countries
  • Environmental Aspects of Biotechnology
  • Biotechnology and Human Health
  • Ethics, Social Values, and Biotechnology
  • University Research
  • Conferences
  • Journals
  • Precautionary Principle
• Center for Science, Policy and Outcomes Working Papers
• Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction - Entered into force on March 26, 1975, among the UK, US and Soviet governments.
• Creating the Next Generation: Scientific Developments - Comments from Dr. Keith Campbell, Ph.D., a scientist on the team responsible for the cloning of Dolly the sheep and co-inventor on the patent.
• DNA Patent Database
• EuGenesis
• The Future of Public Plant Breeding Programs: Principles and Roles for the 21st Century - From the USDA’s Advisory Committee on Agricultural Biotechnology, Aug. 2001.
• Genetically Modified Pest-Protected Plants: Science and Regulation (2000) - From the National Academy of Sciences.
• Grain Crop Improvement Research
• Inter-Agency Network for Safety in Biotechnology (IANB)
• International Food Policy Research Institute Publications
• Human Genome Project
• HumGen Genetic Policy Info Database
• Merging Food Biotechnology and Human Health Therapies Down on the Farm - Project from Chicago-Kent College of Law.
• National Academy Press
• National Biotech Register
• Patent's Place - A must-see. A humorous, cartoon, user generated soap opera about Biotech folk.
• Permiting, Notification, and Deregulation of Genetically Engineered Plants and Microorganisms - USDA, including forms.
• Pharmaceutical Online
• Pharmalicensing.com - Tool for pharmaceutical and biotech licensing executives.
• Pharmalicensing's Licensing Directory
• Publications in the field of Biotechnology and Food Safety - From the Organization for Economic Cooperation and Development (OECD).

MegaLaw.com® is a registered trademark of MegaLaw.com, LLC.

Copyright © 2000 - 2004 MegaLaw.com, LLC
All rights reserved.