X-Message-Number: 28285
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)


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.


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:


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   

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