Having just received the below from an official with a national milk
banking organization (who shall, for now, remain anonymous, unless
and until I get permission to share that information with you), it's
pretty clear where this would be headed.  You don't have to be a
lawyer to recognize that this letter has "Law Suit" written all over
it.

Again, if anybody has any suggestions as to how to make this
recipient/donor referral service fly, safely and without fear of
legal recriminations, I'd really love to hear them.  I've received so
many positive responses from people (professionals) who couldn't
wait to be able to use this information exchange, and it just breaks
my hear to be muscled out by the big business milk bank interests,
but I just can't afford the liablity and almost certain suits.  Sigh.

--------Begin Forwarded Message:


I have had several people forward your original e-mails to me,
announcing the formation of the Milk Exchange.  I have also looked up
your web site.

I also understand that you reside in California where it is my
understanding that all milk banking operations must be licensed tissue
banks operating according to California legislation and public health
regulation.  The Milk Exchange does not comply with these laws in any
way, shape, or form.  According to your web site disclaimer you are
not doing the very things required of anyone running a donor milk
banking operation.

And donor milk by its very nature is an exchange of milk from one
person to a biologically unrelated recipient.  Facilitating this
exchange is "milk banking."

Since you were last involved in donor milk banking in the late 1970's
the donor milk banking picture has changed dramatically.  Thanks to
the advent of HIV, there are now guidelines for safe operation of
donor milk banks. These guidelines were developed with advice and
input from the Centers for Disease Control and Prevention and the
Food and Drug Administration and first published in 1990, with annual
revisions.  "Kitchen" milk banks similar to "Milk for Life" in New
York in the 1970's are no longer allowed because of their lack of
quality control and safety, and all milk banks currently must operate
in a hospital or similar facility and have medical oversight.  All
donors must be thoroughly screened by blood test and all
milk must be pasteurized to prevent transmission of both viral and
bacterial diseases to recipients who are ill and therefore
immunocompromised.  A prescription must be obtained before milk is
dispensed.  We are no longer talking about just alternative nutrition
here, we are also talking about medicinal therapy and an ongoing
tissue transplant.

Your Milk Exchange flies in the face of all the safeguards and puts
you as the clearinghouse operator (and your family by extension) at
extreme risk for liability (despite your disclaimer) because you are
providing a formalized mechanism for people to share their milk
without ensuring that any of the safeguards are in place.  People who
access donor milk through a formal milk bank can be assured of
getting milk from screened donors that has been heat treated.  The
milk bank has covered the cost of the donor screening.  What is there
in place to ensure that parents of potential recipients will get all
the screening required from potential donors or be able to cover
these costs?  What assurance do you have that parents will acquire
pasteurized milk or pasteurize it themselves?  There
is currently no method of home pasteurization that has been approved.
There is no quality control involved in placing a pot of milk on the
stove.  What temperature should the mother of the recipient heat it
to?  How long should she heat it? What excess damage to the milk is
occurring from uncontrolled processing?

You may also be violating Food and Drug Administration rules if you
are helping to arrange interstate shipping of milk through your
exchange. When milk banks need milk they can always get it from
willing donors.  Milk banks also share milk with each other if one
runs short, knowing that donor screening has occurred already.  When
they do not need milk, (i.e. recipient demand drops) they do not take
donors.  This is the current situation with many milk banks today -
they already have ample milk stores and there is no point in
accepting more milk when they have no place to put it!

While your motivation for doing this milk exchange may be of the
highest degree of altruism, you are doing donor milk banking a great
disservice. Should there ever be an accidental transmittal of disease
from your milk exchange, all donor milk banking services in this
country would likely be closed down or would suffer from such a lack
of trust that they would have no recipients and no donors.  It has
taken us years to only partially recover from the distrust of donor
milk created when HIV came on the scene. There is still much
education of health professionals to be done.

I respectfully request that you remove your Milk Exchange from its web
site and cease this milk banking operation.




cc:     Kenneth Dominguez, MD, Centers for Disease Control
        Board of Directors, Human Milk Banking Association of North
America, Inc.
        Clint Venable, California Department of Health

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