US Biotechnology Law
Compiled and edited by Dr. Roland Vogl
Executive Director, Program in Law, Science and Technology, Stanford Law School
- Stem Cell Therapeutic and Research Act of 2005, Pub. L. 109-129 [Alternate link], 119 Stat. 2550.
- Plant Protection Act, Pub.L. 106-224, Title IV, 114 Stat. 438 (June 20, 2000), codified at 7 U.S.C. 7711~7719
- 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, Code of Federal Regulations (CFR) Title 7 Subtitle B Chapter III Part 340, latest amendment in in 72 FR 43523 (August 6, 2007).
- Federal Plant Pest Act, Pub.L. 85-36, 71 Stat. 31 (May 23, 1957), codified at 7 U.S.C. 150aa
- Repealed. Pub. L. 106-224, Title IV, § 438(a)(2), 114 Stat. 454 (June 20, 2000), codified at 7 U.S.C. 7711~7719
- Simplification of Requirements and Procedures for Genetically Engineered Organisms and Products Federal Register, Volume 62, Number 85, (May 2, 1997)
- Genetically Engineered Organisms and Products; Notification Procedures for the Introduction of Certain Regulated Articles; and Petition for Nonregulated Status Federal Register: Volume 58, Number 60, (March 31, 1993)
- 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: Volume 52, Number 115 , (June 16, 1987)
- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Ch. 125, 61 Stat. 163(June 25, 1947), codified at 7 USC 134-136
- Plant-Pesticides, Supplemental Notice; Proposed Rule, Federal Register: Volume 62, Number 95 (May 16, 1997), 40 CFR Parts 152
- Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act; Proposed Rule, Federal Register: Volume 59, Number 225 (November 23, 1994) 40 CFR Parts 172,
- Microbial Pesticides: Experimental Use Permits and Notifications, Federal Register: Volume 59, Number 169 (September 1, 1994) 40 CFR Parts 174 [Alternate link]
- Statement of Policy; Microbial Products Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Toxic Substances Control Act, Federal Register: Volume 51, Number 123 (June 26, 1986) 40 CFR Parts 180
- Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988, Pub. L. 100-532, 102 Stat. 2654 (Oct. 25, 1988), codified at 7 U.S.C. 136a-1 Reregistration of registered pesticide
- Federal Pesticide Act of 1978 , Pub. L. No. 95-396, 92 Stat. 819 (Sept. 30, 1978), codified at 7 U.S.C. 136 w-1 to w-4
- Federal Food, Drug, and Cosmetic Act (FFDCA) (Copeland Pure Food and Drugs Act) (Food, Drug, and Cosmetic Act) ("FDCA") (Humphrey-Durham Act), Ch. 675 (June 25, 1938), 52 Stat. 1040, codified at 21 U.S.C. Ch. 9
- Statement of Policy: Foods Derived from New Plant Varieties , codified at Federal Register: Volume 57, Number 104 (May 29, 1992)
- Guidance on Consultation Procedures under FDA's 1992 Statement of Policy , FDA/CFSAN, Oct. ,1997
- Proposed Rule: Premarket Notice Concerning Bioengineered Foods , Federal Register: Volume 66, Number 12 (January 18, 2001)
- Guidance for Industry: FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues (January 19, 2001) in accordance with Good Guidance Practices , 21 CFR 10.115. 65 FR 56468; September 19, 2000. Recommendations withdrawn on April 25, 2008. See Federal Notice 73 FR 22716.
- Dietary Supplement Health and Education Act of 1994 , Pub. L. 103-417, 108 Stat. 4325 (Oct. 25, 1994), enacted at 21 U.S.C. 343-2, 350b, Subchapter IV of FFDCA
- Rare Diseases Orphan Product Development Act of 2002 , Pub. L. 107-281, § 1, 116 Stat. 1992 (Nov. 6, 2002), enacted at 21 U.S.C. 360cc & 360ee, Subchapter V, Part B of FFDCA
- Animal Drug Availability Act of 1996 , Pub. L. 104-250, § 1(a), 110 Stat. 3151 (Oct. 9, 1996), enacted at 21 U.S.C. 354, 360b, Subchapter V, Part A of FFDCA & & Animal Drug and Patent Term Restoration Act Pub.L. 100-670, § 1(a), 102 Stat. 3971 (Nov. 16, 1988), codified at 21 U.S.C. 360b
- Generic Drug Enforcement Act of 1992 , Pub. L. 102-282, § 1(a), 106 Stat. 149 (May 13, 1992), enacted at 21 U.S.C. 335, Subchapter III of FFDCA
- Radiation Control for Health and Safety Act of 1968 , Pub. L. 90-602, § 1, Oct. 18, 1968, 82 Stat. 1173, enacted at 21 U.S.C.A. §§ 360hh to 360ss, Subchapter V, Part C of FFDCA
- Statement of Policy: Foods Derived from New Plant Varieties , codified at Federal Register: Volume 57, Number 104 (May 29, 1992)
- Toxic Substances Control Act (TSCA) , Pub. L. 94-469, 90 Stat. 2003 (Oct. 11, 1976), codified at 15 U.S.C. 53
- Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act , codified at 62 FR 17910 (April 11, 1997), 40 CFR Part 725 - Reporting Requirements and Review Processes for Microorganisms
- Wholesome Meat Act (Meat Inspection Acts) , Pub. L. 90-201, 81 Stat. 584 (Dec. 15, 1967), codified at 21 U.S.C 601~691, Ch. 12
- Poultry Products Inspection Act , Pub. L. 85-172, 71 Stat. 441 (Aug. 28, 1957), codified at 21 U.S.C. 451~471, Ch. 10
- Egg Products Inspection Act , Pub. L. 91-597, 84 Stat. 1620 (Dec. 29, 1970), codified at 21 U.S.C. 1031~1056, Ch. 15
- Virus-Serum-Toxin Act , Ch. 145, §1 [part], 37 Stat. 832 (Mar. 4, 1913), codified at 21 U.S.C 151 ~ 158, Ch. 5
- Public Health Service Act (PHSA) , Ch. 373, 58 Stat. 682 (July 1, 1944), codified at 42 U.S.C. 201 ~ 300, Ch 6A
- National Environmental Policy Act of 1969 (NEPA) , Pub.L. 91-190, 83 Stat. 852 (Jan. 1, 1970), codified at 42 U.S.C. 4321 ~ 4347
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