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Legal and Ethnic Issues in Epigenetics. Genetic Information DNA Mutation. T. A. Mutation. nuclear. Cell . Genetics: Take Home Message. DNA codes Proteins Protein Binds DNA to Regulate DNA Behavior DNA Sequence Coding Region and Regulating Region
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Genetic Information DNA Mutation T A Mutation
nuclear Cell
Genetics: Take Home Message • DNA codes Proteins • Protein Binds DNA to Regulate DNA Behavior • DNA Sequence • Coding Region and Regulating Region • Coding Region Determine Protein Sequence • Regulating Region Regulates DNA Behavior
DNA DNA Packing Chromosome
Epigenetic Modification Does not Change DNA sequence. Mutation Epigenetic Modification T A
Normal Epigenetic Regulation
Epigenetics: Take Home Message • No change in genetic code. • More often than genetic mutations. • Inheritable. • Affected by: • natural process • Disease: Adult Onset Disease, Cancer • Live Style: Smoke, Diet, Alcohol • Environment: Air Pollution, Toxin, Radiation. • Aging • Reversible and cumulative
Ethical Implications • Environmental protection • Privacy and Confidentiality in Health Care • Equitable Access to Health Care • Personalized Treatment • Intergenerational Equity
Legal Issues • Environmental Regulation • what epigenetic effect trigger regulatory action? • should epigenetic toxicity be evaluated? • Mitigation: reverse epigenetic effect? • 2. Food and Drug Regulation • should epigenetic toxicity be evaluated? • drug to reverse epigenetic effect. • drug to treat disease with epigenetic effect. • whether genetic modified food any safe.
Legal Issues • 3. Occupational Safety and Health Regulation • how to evaluate the safety of a workplace. • does existing law cover epigenetic effect? • 4. Litigation Issues: • Inheritable damages. • 5. Employment Against Fertile Women: • fetus more prone to epigenetic effect • epigenetic effect could be racial specific • 5. GINA
Legal and Ethical Issues - The story of BPA • widely used in making plastic bottles • recent studies link BPA to epigenetic changes • one experiment with rats used 50mg/kg body weight per day • EPA safe level: 0.05mg/kg body weight per day. • what you get from plastic bottle: 0.0000125 mg/Kg body weight per day • = 1300 lbs of food and beverage/per day
Legal and Ethical Issues (inheritable, cumulative) Should government regulate? FDA has not formally banned BPA, but said it has “some concerns.” FDA is conducting further studies. Voluntary Ban by Retailers. Liability Law Suit?
Kerns v. Hobart Brothers Company 2008 WL 1991909 • Facts: • -former chemical employee gave a birth of a child with birth defects. • -the child was conceived when employed. • -exposed to mixture of chemicals including BPA. • -sued for failing to comply with state and federal guidelines regarding the use of • the chemical, causing child’s chromosomal damage and birth defects. • experts testimony that evidence showed that chemical can cause damage. • but there are unknown reasons causing chromosomal damages. • Ohio law requires that an expert be able to discern ALL potential causes of a • particular injury before being able to isolate the single cause.