Advancing biotech, such as human longevity biotech, requires abiding by the U.S. lab-animal testing federal, state, and local laws, if you’re a U.S. biotech business such as my Robocentric.
I pay very close attention to, and actually read, the U.S. lab-animal testing federal, state, and local laws that are freely available on the Internet, because I need to know the U.S. biotech laws intimately for my biotech research, development, and commercialization endeavors in the U.S. and outside of the U.S.
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First of all, what U.S. federal agencies regulate biotechnology?
The U.S. Environmental Protection Agency (EPA), the U.S. Department of Health and Human Services’ Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) regulate biotechnology at the U.S. federal level.
What are the U.S. regulations governing the biotech industry?
The U.S. federal laws that EPA, FDA, and USDA use to regulate biotechnology products are the following.
Plant Protection Act (PPA) administered by USDA
Animal Health Protection Act administered by USDA
Federal Food, Drug, and Cosmetic Act (FD&C Act) administered by FDA
Public Health Service Act (PHS Act) administered by FDA
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) administered by EPA
Federal Food, Drug and Cosmetic Act (FD&C Act), Section 408 administered by EPA
Toxic Substances Control Act (TSCA) of 1976 and as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act administered by EPA
Endangered Species Act (ESA) administered by EPA and FDA
The United States Code, available at uscode.house.gov, is a consolidation and codification by subject matter of the general and permanent laws of the United States. It is prepared by the Office of the Law Revision Counsel of the United States House of Representatives.
The United States Code Title 7 Agriculture, and Title 21 Food and Drugs, in particular contain the U.S. federal laws that are applicable to biotech.
The United States Code Title 7 Agriculture, Chapter 54 Transportation, Sale, And Handling Of Certain Animals (Sections 2131 To 2160)—also known as the Animal Welfare Act—is the only Federal law in the United States that regulates the treatment of certain animals in research, teaching, testing, exhibition, transport, and by dealers. The Animal Welfare Act is enforced by the USDA through the Animal Care division of APHIS (Animal and Plant Health Inspection Service). A biotech research laboratory, that performs testing on certain live animals covered by the Animal Welfare Act, must abide by the Animal Welfare Act. I intend to perform animal testing on the Animal Welfare Act covered animals for developing and commercializing biotechnologies, so the Animal Welfare Act as well as other U.S. biotech laws are of great interest and importance to me. According to my estimation, operating a biotech research facility with live animal testing capabilities that is applicable and conforming to the Animal Welfare Act will require at least US$1 million annual overhead or biotech business expense, so it’s a significant, if not an enormous, business commitment and financial resource expenditure.
The requirements of the Animal Welfare Act are set forth under the Regulations and Standards in the Code of Federal Regulations (CFR). These requirements are found in Title 9 CFR, Chapter 1, Subchapter A – Animal Welfare, Parts 1, 2, and 3.
The Code of Federal Regulations (CFR) is not to be confused with the USC, the United States Code, which represents statutory law, not regulatory law.
I’ll eventually look more into all the applicable U.S. federal, state, and local biotech laws, including and especially but not limited to medical biotech laws. I’ll also look into the difference between the U.S. federal statutory law and regulatory law; I don’t have a formal educational background in law, so I need to learn.
I’ve a multidecadal commitment to advancing biotech; I’ll do everything that is required for advancing the human longevity biotech and other biotechnologies that I envision and pursue as specified in my book titled The Future, and at Robocentric.com/About.
You can invest in my startup company with as little as US$100, for supporting advancing AI, robotics, biotech, and nuclear-fusion powered outer space tech. Visit Robocentric.com/Investors to invest in my startup.
My books on advancing AI, robotics, biotech, and nuclear-fusion powered outer space tech are available at Robocentric.com/Checkout, Amazon, Apple Books, Spotify, Google Play Store, and other online audiobook retailers.
I am Allen Young; I’m an Asian-American man who focuses on advancing AI, robotics, human longevity biotech, and nuclear-fusion powered outer space tech.