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M E M C 3 A N Dv-U M ---------------------------- "
Re: Polyvinyl Chloride Plastics and Vinyl Chloride Monomer Problem
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In light of infornatioi us, on behalf of The Society of,' we are deeply concerned about tj we understand may now be under polyvinyl chloride plastics foot fearful that some of the salient stood and that, unless they are,|j
plastics industry will be sevaj any concomitant benefit to the general interest.
tich has recently reached Plastics Industry, Inc.,
_/pe of regulatory approach federation relative to
lekaging materials. We are |cts are not clearly under-
f taken into account, the idversely affected without j.c health, safety or
Ever since October were submitted in response tion's first proposed rulemaJ its prior sanctioned status*..^ sanction be reaffirmed but tf for the first time to assure monomer {which is not prior 41
We continue to urge recommend strongly that the fc favorably and et. ployed approprj rulemaking which we now underdj
fewh en SPI's Comments and Drug Administra
te ly vinyl chloride and ^advocated that the prior
Rations be spelled out tere will be no vinyl ied) in the food supply.
'-i"^adopt this approach and
concepts be considered in the redrafting of Is taking place:
1. In our view,
the most
important things the-;.
and Drug
Administration can an#j i'oulci do in
dealing with this probp is to employ
the Preamble of any prt" >sal to explain
carefully tnat, while
syl mo nonunin may
be a carcinogen V and'U'S not the 'sub
ject of a prior sanctadn as the same is
defined in the Food Additives Amendment
1958, polyvinyl chloride is an
w
"*7 It is conceuee that vinyl monomer, a highly volatile gas
at room tempera trr a, is a carcinogen when inhaled in high
doses over long p riods of time. There is no conclusive data
to indicate that -i.-.e same *s true as reaards ingestion of vinyl
monomer; it may r.et, there :cre, be do tit with as having beer,
found to indue- : ;.-.ce: af*. s costs "aopropriato for the evalu
ation Of tlv . : -v of : :
-,cd ; civ -r, . "
VC3863
*, f * 'V` - **
*.-;
y >v- **>' &-
entire*'/ airier..-,
wav that tox.c c.:
-."C 1 171
chloride (table salt")
hy.rV:
as inert, hat beet.
jbj :c 11 "tter.s ive
feeding i
mve 'shc-t. it '-J he
hamlets ,en he
id, hence, is very
properly the subj,<
tprior sanction
under the Focd Add|
lendr.ent.
2'.'. It is our .sanction should^
..COUldr ^sanctior
?S4
chloride,
iian.
proyj A* vs.
of r,*sv. tpJ
'M; ttith
jS 'sSCt'i Si.*W
it Us our urgent
rea fifi rmation. r( that it
polyviny)
equipr.eni
and safe
monomer
t/actlonj ptoc
exaggerates in tenSS
and f2) that a Si
extractabi1i i
birr
:guli
the prior
id a van * hough
pjrt need not be
li^r.ce prior
fierpt from
ires Amendment,
has been
jSB^yyinyl * t n
^inqe 'its.
ft ashd&result
`-^ondAer^ J
rus-bthatti
|i clllorit
thwhile. codrrter
-t:-m
ier vth*n ^ iJr,
IP's score,*,!; imposed, in the
appropriately
bat-'the presence
11 not-fei` ier^a
t
TjT pitions foremost,
a prior sanction
ae proposed and
all forms of
fing or processing
'prior sanctioned
|Ls. no detectable^/-
J_'">exr..using ex-; -
isonablv
w of use,
he'for analysing
in s- ft .1 tr-
fa!th rrgard tn
1.
Jv? : r,; ,.
3'
>&
F- ' ^r - Vi*'* *$3
V"A
.. ^ - -TCi, ^
VC3B64
S^r ;; -I*
%
the metrod pit I ish r*<; , itbe or.o t.. it. his beer at ij validat . i .c'.o w.li be relf
practical day-to-day apoi believe that the`Food tration's Staff has d methodywhich carrot reafiinaartt^pn pfg V> i
We
%-l&i
sthl he
>ss 5exac
fcFssS'i lO'&fi
rated, e__ jis -not'*#
-v pSl Si
:a*ss| liJtopctatr
ratios ?"ddrti|fea|
. .^e caters < X px^jpoSi t'"o f the . ' if^fcbe Food arid Ogua^
; ' deeffls. ji t^'iid^isab^.. of*^j " might visirto nota thii
>coiaCRdenua*yv BE?on-sxV . calieuJiHRG-^e^pmi.llriVtn
will. monomer enfeirs^rl fbodjt
- ov^r, ,inetted
'w
( I.
^K-'
:' i^;
.-r__t_ah___ei__l_f-_l_^lisi___m__tr_r_in_t____a_t__i_i-t_-s^tl--prn_r-n____w_~s--_o'_^i_ujz,elljd9l1.--Fbe-o-*__ca__ ^l
&*L`-
"far more seveco^tfiar. 'ra
' ' already bfap imposed ^r; Safety arid He^lm . - hnnju ^ + .. circurst.--.son vl -re e^p^ chloride ~or.C'f't it noti'af^'
m
ceptaal possibility, bu-t certainfy;; "The OS.:;. \ .re pofmite vote e r exncf.ro of" pafTmi 11 ion for a:. c f .v
rde- H i -` f..
________
Sth
tr.. .
r.l5,j
W-
'1
iction A
|KoreIg that pa
id be ,
fclt.ior.al ItOSHA) So vinyl
car. ,.ufc o Standardt1*",-
. T. 1
VC hftf C.
every word in u::v. ""is -if
equiva.i
pern it.i.To 1(
vinyl cr.i:n_s ir. tie ted .diet
be ingested daily, i: such;
which it is obviously not
interesting to note that'
Research Group participal
the OSHA procesdir.gr whii
. adoption of its Standi
not appeal the! OSES- dec!
did. in fact'i>HRG sj
ieved^to ftwe be
thepi niornC.that / *
ory hadbbeen yjf
^theia^iafe:
V* -r,5j , 4`- ". . ,,c&, J tration should
>a and Drug Adminis>e principles outlined
as is provided in
ienminwaaf ipj mM; P^y'-xel
Several motivating or lich we feel comoelied
rC&x,
V* Our da.Q t--t*.e**. n,ti'Vo,vnv'^lPl
r%v 'T s*.. i- r
status
contact'
r%h -its ry an&: very
fcsit with
feated
sL ...
re concern
of 'the^
the food
customers
rstics in-
Any formal pi
iich, though
d as-only a
adds to ,,they
le climate^wi^
)tedly- cai;
grcxs ^unjustifiable
vis-a-i '
*?*.!>
ic*s sense ofysecui
3^.-
-*
: .?.rH>fc '
_
- It is generally?
that the,
txy b .now, supply*
ily vinyl gfV
"L>*` is :i^'-' iici$j
to i ts'... visigni^-
^fron 'tli a iin the nar-.e^Blaceh
fcalS' that j JT O
. the HRC rr? fcrero^c cutrue
, submitted. Th_ uvniibi 111
m
n,i
'^,1 -SAr-t
'Jcy.Shf,
5
these new materials can be documented. Use of them will assure there can be no reasonable expectation that poly vinyl chloride packaging materials will lead 'to vinyl monomer becoming a com ponent of foods, or will be ingested.
He believe that many
.ng resin
and compound supplying
ties have
already advised the Foci
Drug
Administration on an ini
1 basis
as to the changes that
rbeen made
in their food packagi
le products
to provide this type
/assurance. If
more data is needed,
r, we can
ask that it be supplied; d'would urge
that the Food and Dr
stration
receive the same bef
es any
precipitous action
injure
the indus try' s reputh'
parably.
Heckman id Heckman
unsel for iety of the cs Industry, Inc
i V
A
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I
-3*
VC3867