X-Message-Number: 28285 From: Subject: Re: Embryo cryonics-- CI officially rejects the idea Date: Sat, 5 Aug 2006 04:02:49 US/Eastern human screener <> wrote: > In a startling new development, (startling to me, that > is)-- CI has officially indicated to me via an email > from Andy Zawacki, CI facility manager, that they > will not accept embryos for storage and that there are > no plans to do so in the future. It appears that this > was decided at a recent board meeting of the CI > directors. There was no reasoning behind the decision > in the email I recieved about this-- only the > decision. I'll likely ask Alcor for their official > position soon. I'll explore the implications and > extrapolations of the CI position in a later posting > to Cryonet. For many reasons I would be delighted if CI could offer cryopreservation services for embryos, cord blood stem cells, etc. However, the capital requirements could be large, especially if we were to attempt to comply with all the regulations. On the advice of legal council CI is not going to venture into these areas at the present time. Some of the regulations can be found among the US government Code of Federal Regulations (CFR), also denoted United States Code (USC) http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1 Title 21 United States Code (USC) Controlled Substances Act 21 USC Section 301 (The Federal Food, Drug, and Cosmetic Act) 21 USC Section 301 has been amended by additional stringent regulations intended to prohibit human cloning. http://thomas.loc.gov/cgi-bin/query/z?c109:H.R.1822: Title 21 Code of Federal Regulations (CFR) Food And Drugs Administration 21 CFR Part 1271 (Concerning Human Cells, Tissues and Cellular & Tissue-based Products) 21 CFR Part 1271 is intended to prevent the introduction, transmission & spread of communicable disease. There are requirements to establish donor eligibility, with all procedures requiring review and approval. Donor screening must test for HIV 1 and 2, Hepatitis B, Hepatitis C, HTLV I and II, Treponema pallidum, CMV (Must have SOP for release of positive products) -- by FDA licensed, approved or cleared tests. Storage facilities must satisfy FDA requirements for environmental control, equipment, supplies & reagents, processing & process control, labeling controls, pre-distribution shipment & distribution. Staffing must be approved for number and training of staff. There are extensive record-keeping requirements. Penalties for failure to comply with FDA regulations can be severe, including fines and imprisonment: http://www.fda.gov/opacom/laws/fdcact/fdcact3.htm Biologics are subject to additional precautions based on the Public Health Service Act, aimed primarily at control of transmission of infectious disease: Title 42 Code of Federal Regulations (CFR) Public Health (42 USC, Chapter 6A, Part F). The Chamberlains attempted to create Cells4Life when they were at Alcor. Although I don't know much of about the details, I understand that the result was a financial disaster. I can understand why there might be a lack of enthusiasm for repeating this project among Alcor Directors. -- Ben Best, President, Cryonics Institute Rate This Message: http://www.cryonet.org/cgi-bin/rate.cgi?msg=28285