comment to FDA on medical PVC R-To-K petition

[ttweed@wildrockies.org (Tony Tweedale)]

hope I'm not repeating a previous posting, but i see Health Care W/out Harm
persuaded FDA (or FDA was obliged) to take comment on HCWH's petition
that'd require a risk warning label on all PVC medical decvices that leach
phthalate plasticizers (and require long-term or pregannt i.v. users to be
warned they may receive a high dose of plasticizer).  It'd also require
promotion of alternatives.

I didn't see this one because EPA's FR listservs don't carry many FR
notices from other agencies (and I don't know the last day to comment), but
if granted, it'd go a long way--in an instant--towards taking this market
away from PVC.

comment to FDADockets@oc.fda.gov --must include your full name, the Docket
# (99P-2077CP 1) and the title:
"Citizen Petition for a Regulation or Guideline to Label Medical Devices
Containing Phthalate plasticizers and to Establish a Program to Promote
Alternatives."


If you need things to say:

- PVC & plasticizer free alternatives are already on the market.

- DEHP (the plasticizer for iv bags, tubes, etc.) has serious health
effects, at doses to which regular users of i.v. already receive!),
according to Health Care without Harm..  DEHP is a carcinogen and is toxic
to many organs.  Unlike many other situations, you approve the highly
leachable toxin being delivered directly to the blood.

- Developing organisms are generally a little to millions of times more
sensitive than adults, yet much of the data relied on by FDA to market
these medical devices rely on toxicologic tests using adult animals.  Thus
FDA is failing in its mission to protect the public.  In fact, FDA does run
the proper toxicology "experiment", except that it is uncontrolled
(therefore the results are unknowable), and the risks make it unethical, as
FDA is using the American people as its subjects.  The instant petiton is
an excellent way to achieve a measure of informed consent (and reduce tort
liabilty that health providers, perhaps even the federal government, might
face).

-Such PVC medical devices add to the medical waste stream, much of which is
incinerated, leading to one of the largest sources of dioxins and other
highly toxic, persistent & bioaccumulative organo-chlorine compounds being
dispersed into our breathing air.

Tony Tweedale

Causality is a concept not subject to empirical demonstration. -David Hume
(1711-'76)

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