ML19322C270

Decision to Withold Distribution of Potassium Iodide During TMI Event:Internal Working Document

ML19322C270
Person / Time
Site:	Crane
Issue date:	03/28/1979
From:	Macleod G PENNSYLVANIA, COMMONWEALTH OF
To:
References
TASK-TF, TASK-TMR NUDOCS 8001160733
Download: ML19322C270 (28)

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~he Cecision to Withhold Distribution or Potassium Iodide during The Three Mile Island Event:

Internal Working Documen:

Gordon K. MacLeod, M D., P.A.C.P.

Secretary of Health Common 3*ealth of Pennsylvania O.

sex 90 narriscurg, Pennsylvania

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On Saturday morning, March 31, 1979, a meetine.was held at the Pennsylvania Emer ency Manac.emen Authori v '~s (Civil v

Defense)~ headcuarters.

Present were top PEMA officials, clus Clifford Jones and Thomas Gerusky fr== the Department of Environmental Resources, and Dr. Gcrdon MacLeod and Emmet: Welch from the Department of Health.

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A total of 237,000 bottles, manufactured under Lo Numbers J103N, J104N, and J105N, were received and inspected.

During the inspection, it was noted t.nat many.o:. tn.e cott_,es in the first shipment (J103N) contained hairlike filamentous material and other particulate matter, which indicated the

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I

_,._ S.,. _ aSSow_... w _,.w 4 _ oW_ _.. s. e _. _..,,._. _-...

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v we has been..,oun to be eminent.3y suita=_3e :.or :nyro:c...cAccp:.ng a

oses.

e,v a s s.4.,.

4 o A.4.c e b _1 o Cx s _.n.

3.d.e, :

_ _t.1,.

y-f

- r..

a _3mos: '.nec.' ate _$ v, wit. the onset of b_3ock..n nav n=.

ceen cemonstratec 30 minutes after oral administration.

.-.nc wnen c.:.ven in su:::clent amounts,

e. n t r v. c:. rac:.olocine into the thyroid can vi_ ually be.=revented (1% in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />).

o -..=... # a c

_ _'. c a" - = _d.. _4.., s a._d.e. # a c., v.

'. _' o "x.'..

4.

..e e.

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_'s

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e y,y o s.. _..

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he c,,_,k c_e cne ae_,,,a _a. _ve

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a

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I l

50%)- is attainable only during the first 3 to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />.

For.

4 l

a mcre pro _onged exposure, owever, n2 w _, _. continue to be j

,, e e _e._. _' =..=.. v.

c _d..

d"

_d. -

..".e a..r w^ = "-_ e,..'.". s _'

a.'.. " ' d. " =.

e -

_ m.. _".. _" s. a _- a. d eva.. _' _#

_4. wa s

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,4

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.....,a_.

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c_...

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e.c.= ' -

=.'.a. d.

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s " e - - a. e s d o.,

=.....--

a-d^se 4

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r.

0 0.....: -- -- - -.

a nataa a,

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-a;

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-a

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.e

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i.

d-.

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s'ow,

~~

4 in an adequate block.

The National Council on Radiation Protection has suc.c.ested that dailv. doses be continued to an accumulated limit of between 1 and 1.5 grams of iodide, or for 8 to 10 dav.s.

The NCRP also suc.c.ests that after.10 dav.s of the iodide regimen, an..escac.e errect.. occurs wn10.w..Orevents.

..Se '.hv. odd # om.ak.4.7c. on o

.-=..='..'.7

'"-..".e-doses cotassium locice.

a niatus or severa, cav.s must tnen taxe ce a _e^.. ve'v.

e=cr--.. s a e.

-'aca e o e

• -.7e ^-*"y m a v.

c., '." o u

.'m...h e "o s s.'." 4 ' '.": c3 a.

es

=c.e.

e.h a...r me..-.. 4 s e

.= s -

..a... 4 ^ n e d 4 a m. em.,-~a a..d "..

-a

=

^= a..^...

. e. -.. - _- ";

e I

a

^#

..he W.h.'.=.

~d.e " s e a- = " "-, s~ma. -

sa,-.=.me...

'd wa.. Wa-'.a

-a 1

among the experts as to the legitimacy of this effect ac.carently exists.

Dr. Reed Larson of Harvard Medical School most emphatically denied its existence in a telephone

--.ve_sa- 'o..

..he De,a-me..

".a.=._'.'.-

D.

a so. - =-= ' - -

c..es.e...na.

D.

va h..=-----

a w._a.-

.; e i

os.-._-.....%.

f-.

.... O.

.. g h

8 8

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g-1

'd -

m.J gJJ

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'./..,.

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JJ8 a

4 p

m.. c..n.-ge.-

3...

.sg 77.--a

.-J.g J bq.

• g JJs

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a. -. m.e 4. g

.g.m=;

b.3

... e..

- - - =..e.

m w;

w...;

77

... g.. a y e..n..,. L. g J *

• e g. 4.%. -. ; g A.. 4. g--;,agg.

4...o.4 m.....

y--

1..... e.

u..

..w. a. '.J. e.m. i..b.

J

• e......e. w... -....c -

L.

__O,a

.J t,q..

e ec-v..

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- s.. a -....i n...

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%.a.u.

.ne e-

,-a n..

J:

a g r ase

^#

. =.. exe'os've

=~as- -.".-."..'ec-e~e....

e Emergency Advisory For Protection of the Thyroid Gland from Radio-Active Iodine (I-131) i l

l I.

Ucon announcement o:. :ne 1=minen:

11xel.hooC o:. s eni:1 cant.raciation exposure,.c.rotect.vourse :..

ov remain ng in an area removed from the outdoors, such as a basement room or other such protected area.

Anticipate the need i

i

or water anc,coC s u =. c a v..

1 Even if stavine. in a er a:

II.

the time of announcemenotected area, t of the i=tinen:

i c. ' # 4 c =...

a d.' c-..

,4-

. xe_-.Scod o#

tax. s...-.. 3c assium.'o..

e 11gulO oC Ce

exposure, a a-e. -...m,..,.; e ;.:. -.. u e, ok.

2. c o a s.e.:..

oCice Wila. recuCe :ne amount or raclo-o u.4 7 e *. a k e..

.'..".~. o V o u - *..". v. - ^ '.#. C.' =.".#

J

. a x e

%,4. u..t.,.

J.o s.voL..s cJ a a

n

..C;a.e.

exposure, anC wil3 beloe at least some Va, US 1

ne 1.".1:la Case is taxen ut 2:

i 22 nours a::er racia:1on exposure.

J

.. PotasSlum a.oC1Ce n.Cministration AA..

L1qu1C r,nc~er one a

vear or ac.e. r... ut one

~

w O

(3 CroD.o: 3otassium otice e..lc.ulO a

r s s a..,. a. e_ 4_

so.1.,. e o

4...

...nn.o._.ss--...

oC44e, SSKI) in a glass of water or juice.

I i

=

l l

l l

l

ny..--...g

= _,

.a...,

_.z..a_..:

. _, s e.._....

- _ n.. a.

-a r _,.._. _. _.._._ ;

a.-

_ =- --.......__e_e

_-.:=,

ss

.e e r.- s _.. _.

.a_e,

.: w,

..,...... g e

,.__-_,_._a,a_

p.

ggna.

a~e

. e a-d = v.

. =..

's.',

- =...";

e

('^i av.s (.5 =. ' =.. =.. a d. #.s e d

=.. a., n...,

-2.,-,._

.o e.-. -.... a....

.. l:are).

we.

Gordon K.

Mac~eod, M.D.,

FACP S e.. e. a.- ": o#

=. = _ .. '.

Commonwealth of Pennsylvania March 31, 1979 D.

Supplv The n.otassium iodide crec.ared for Harrisbure. was

=.ackac.ed in, one-ounce sc.uare, amber glass be :les or two-ounce round, Ember glass bottles 1/2 full.

Each 4

bottle contained at least 30 c='s of KI solution.

The droppers received were' calibrated to deliver 30 dr, ops i

per cc. c:- so_, ution, t.w.us each bottie wou_,c east,v. s u r. e.., v.

900 d:co.s.

Given the labellec. cally dosage o:. two crc =s :.or anc

.k_a_nA.e..,

gnA ona c-

._.:m.

a p,.1 - e 2,

-.. - n ~. s, _ ~ _.as.

estimatac :.at eacn cottz.e wou_c crovice,, 0 cerson-doses, l

or would supply 45 people for 10 days.

The shipments of 1

KI delivered to Harrisburg would, then, be =cre than enough to =rovide a full blockine. rec.imen for all =.ersens d#

a.

_d_ek. o# exposu =_ --..". e v _4 _= _' e - s " _' # ke d_'*._ _d'ou.ad

-^

persons who would assure their being shared with severa.

-_ne-.

_:.e

._; a's d"-

_4..-

...=.. =...

a- ". =

1. -d.

".o..,_-=..~..=..

_=. =... d a ": - - a..= ~. m..=.... _'=. wo"-'d k

'-=d de

-e.-=.-"-------

...=.

i

.. a-

.n a

e

.w....o.

w.

\\..

...-=2 e-.

w

...e.

.....,... _,.e.e

---...D u -----

e.....

.u.e 4 -

.e.a.. : - -e.. -

.e... e. e...

3-e, w...

---.e..

---

as-.

.r.

..a....,

casa

a-.e

.c.o v.. -

3-.assi". dodide is a e'a-dve'" s

="'e, e..-3..

d--

.w

-o y

A-"c.

.5.=..".a s Saeen "-sed as a.. exc.e

- =... ' -

..a..v. "e=

s in the treatment of asthma and other bronchial conditiens with few, if an.v, side effects.

In the treatment of resc. iratorv. insu_,_,iciencie s,

is a= ministered n

oses of 2 to 10 times the.cotencv. of those recommended for thyroid blocking; thus, few side effects are expected from troc.hv. lactic administration because of the low dosage and short regimen.

As with any drug, however, there is always some risk

=

associatec wit.s.

ts ingestion.

,s.e incuct on c:.

env.rosexicosis nas seen o. servec in ts.e =rochv.a. acts:

.. e a me... o ' 4 d ' ne d e = 4 ~ ' e...-

c. d.e, ~..'.o,.". '. uw.x c' mn c e.,._, _.y e, y oc-n.---t.,.

og -a.

gn _ e :

c-a g s

.u. a s a

a 4

..'.a.

U.._d.ed.

.c..=. a s.

Neve_-..he ' a s s, d o d d..a_

i..e.. - a d-3

_d.e.-

may occur in areas c: su::: len iodine intake anc. snou3 c be watched for in the 4% of the population with nodular goiter conc:: ons.

-ee:-

wG...DG

-ww--G.e

.-..e.e

..w..

.e

--ww...--

w----C-y b..

..h. o.

.g---

• b...- 4 4 a

.,.f. e_ n.

ob W,.

-3. 3 =. -,. -,;. w g..-.. -. 4 g.

7 -;

..;-w--r

.. s*

.a...

s.....n..= ~;. d

=..b.';' = a.4 2 w.4 4. J.o..=. =. c A c. *'4..c..= c 4 =. =.... b. e.w.e.

o w

..A...

.b. g.. e.

.", e a..'. ** *"...

• y". - 7...'..'. ;

• * ~

^--

A.

7w J*..... m... b.

. n' g. a. 4. e.

4.. J m.

m..c.

4. m.

_J

_g

........ e.

. _. _4

. m. A W w w ;..

y y

b.,;.

..b. o ] a m g w.=.6 =.

w.J

• c..m..*

..b. p 4... e.s. =. 4.w..,

34 - eg e.'.#.". e o.

m y

p=

w

_2 _._=._ _ _a.u.... _a.m..

..... u. e,.,.. _a _. _,._ _a m.

o..u.,.

-,... c...

women may be ad=inistered.. prophylactica,y, they advise s.

...a.

..".e s e wem. e.. be y _' a ed_ ur.de. _= _do-.

's

_=_-=_.

.The taking of iodides has been associated in a limited nenber of cases 'with either hvo. o or hv.o. erthv.roidism s.

in natients wno had no crevious utstorv. c:. t.nv.roic cisease.

"hese reactions would be unpredicted due to :ne lacx c:

previous history, but may be expected to occur in 1 :: 4%

of the ecoulation.

e..

ce e::ects may a.,so occur wu.len co not invo_,ve the u.

t.nv.ro c c._,anc.

ese ine,u;c :ocice caro: t s an uncommon r

complication resembling the swelling of the salivary glands as is :cuac in mu=ps.

Cutaneous socism, a rare cut extreme _,v.

..-m=.Jo..

,,,.-.-e e.4 s k i.. e.- ' r. 4 ^., ~ =. - - "-

4..

-..d'vid a'e who ingest large doses of iodine over long periods.

Eved less common are such systemic mani:estat ons as :ever generalized skin rash, arthralgia, swollen joints, changes

.. tn.e naar and nal_,s, and gastric upset anc clarrhea.

g

..".a. s e # a v 0 ' - -.a.....'.',,......#..#...

..".a.

". a. _*.*."..=. _~ " -**.. _# '

a 2._.

.._a

..- -.a. n...a -.,

.a..-_

...e

.a.

__c w, _ -

2 s -..._..a...,. _...

.n..._an._a.-

e nsa,

---_..a

..k.a...,.-,.

_...c.....

..y a.

g..u.g-.

..%. g

_, m.*

--..,m_a.g.a..

,-a, yn.. 2

..%.e.

~% g.- a. m.. 4.- a. :.

.e.,_4.y c e. n e..

A. e s 4 a 4 e-

_4

.s.

4 oc_4 A.a..a _4. s.s.

w._4..s. _4 a,ew c.av.s a::er ciscontinuine. loc ce inc.ession, monitoring of the individual need only continue for that period of tioe.

• ha. #c'1owd n e... a. a c. a.h s e.' a. _d..;-

o o.a..._d='

- sk.

were taken from the inser?. entitled " Patient Information Use of Saturated Solution of Potassium Iodide (SSK:) for Thyroid 31ockinc" which was developed by the FDA for Ad

- s..dbu__ dor. wi b

.h e m. e d d a

_4 c r..-

Wh - C a.. "- = >. =. o. = s = _d " ~..

o - _d d a. 0 "v..' e e s " a. u d

2 a - a. a ' t a -.'.-

_ o - _- " a,

' d

.vou av.a.v.e

.a cotassium lodide as directed.

.ven 1: vou a-a

.a.d..d.7q a

.b.;~- _ _d d 5. ^ -.. ~+ n e

.4 -. ---d"-.

1. c an u..de ac__dve

..h.v-. d *

'=..d,

.=.>_#..-

e-a.7 a..4

• hv c4#

- - u

=. ~..-'.'a - = -..# **=.

=t.hv.**4#

c. l a..d.,

.vo u ~a.v s._d _' _'.

women may a_. =.k e

-._=.e s _# "~..

loc ce, Pregnant so taxe it.

Side Effects:

On general, the side effects c: cotassium loc:.de have been seen wn.en hiener coses or potassium lodice nave c.een taxen :or a lone time.

You should be esoeciallv cautious

.n.o. uoo A. ea.- *ne s-..ae.n..O-Cose

.,x..

. w o. a s s d u r.

.d o d _i d a.

. 'o.-e

....h =.

.d.. s._- _.. =. 4..

m..b. a _- a.

are two Kincs C s1Ce er:Sc:s:

those nO:

e

1

_J

_S o.4

- _ w a.

. 6... - = 4 4

._.,...A

.A

. u.e s a p

1

.=w s

w-

.o

-.w

_4..o _*. 4...De

_..W....._4A

. _ c*.. A.

]

-w

-_Ae_

a. : : a n. _..e.

_4.., _..... a. e.

. u..._ _ _a :

A.

m. e..,.,._..; n. _. n a _. ; 6. a.e a

--.a.a

• _..u.

- _ a_

.a

--aw

,e_.

w w-c'-i*.'..

_~_s.hes, s w e _' _'.'..; ^.#

..".a.

s = _ _' ". a -"; ~.' a.. d.e w

y (na-d.4Aa.... ys"),

a..#

_#. # _d.e t~..a*.*__'_'~

~..*. s c.

_w

u.. _.. a.

_4

. u e

..n l

u. c.,. A s'w- - a_ *18.c.e.

C.:

._..- n a,

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at times severe shortness o,.=reann recurring i= mediate medical attention.

Side effects involvine the thvroid gland:

The taking of lodide has been associated with overactivity c:. the thyroic g_3and, under-activity of the thyroid gland, and enlargement of the thyroid gland (coiter).

Goiter may occur also in in: ants corn to mothers who took., arc.e c.oses c:. cotass_, um locide tu..rouc.hout

c. r e c. n a n c v..

What to do If Side Effects Occur:

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A an or Onese s1ce e: ects occ"r, C a.3 _. vour

.anvsician or ub_31c hea_,th autnoritv. :or instructions.

If the svmOtcms are minor, vou may be advised to continue takine. t.ocassium iodide.

If vou have an allergic reaction, discontinue tak'ng potassium iodide and seek i= mediate medical attention.

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However, the taking of iodide has fpeen associated with overactivity of the tnvroic clan:. In elc.erov mersons witn..eart 3

disease.

The svmo. toms c: an overactive :nv.roic gland are verv similar to those associated with anxiety and include nervousness, sweating, anc rapid heartbeat.

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d particularlv. to workers on the island, were to continue for a period of weeks or months, they would conceivably have to go through several c" 'as o# - o.e.._' w../.no

--.e.._' o n a s

..k.e.v Ingestec, ciscontinued, then re-ingestec :ne medication.

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prudent simply to make,the SSK.I available on the 1s_,and wn.ere it cou_,c ce acministerec w thin 30

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quality of the solution of SSKI, and the conflicting reacmmendations,or the lengen. c:. acministrat. on were also factors.

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s

- = <.

At a request from the White House on April 2, 1979,'

Dr. Julius Richmond, the Surc.een General.,.cre. cared a letter of

" guidance" from Federal health officials unbeknownst to the

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. provicinc..cr ecau:Lonarv. socine

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4 3 %.._._. _ s _. c. _ 4, n, ac.-

the National Cancer Institute.

Dr. Ricnmonc,s letter was :orwartec :

Secretary Cal..:ano,

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. ave workers

_,n en.e p.,an: anc c:ners on ene is_,anc n

1; begin taking blocking deses now.

.a nave =otassium 10cice new cersona.._v ava_ ar e to all.=ersons whose.=r=ximity := the site is such.

(c. erhao. s u=. to ten miles distant) that they will no hcve as much as 30 minutes advance warning of I-131 exposure.

3)

" ave potassium iodide available at convenient distribution points for distribution to other persons who may be exposed, such that they can have the medication at leas 30 to 60 minutes in advance of possible exposure.

4)

Accompany all distribution with notification to the effect that:

All persens nav take rotassium

. 1 cersons who:

iccice sa:elv. :or a shcr: tine, n_

a) have c.oiter or known thv.roid disease, er b) are

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J vou devise amount on One.,abe. s.

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Instructions or nas :

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.gooc c: sur::c ent advance warning c:.

releases.

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and nuclear Officials who were actually en the scene and presumably in the best position :: evaluate the danger.

In light of the directive to " Eave workers in the plan and others on the island begin taking blocking doses now"...

Drs. MacLeod and Wald and Mr. Denton re-eva'luated thei original decision regarding the administration of potassium iodide.

Their analysis of the situation--Federal recc=mendations notwithstanding--resulted in a reaffirmation of the original position.

Dr. Wald documented his advice to Dr. MacLeod in the following memorandum:- ~

~

I have reviewed the memorandum.cf April 2,

1979, from Joseph Califano to the Honorable Jack' Watson regarding thyroid blocking.

The recommendations are very useful but may not fit our local cir-cumstances o=:1ma__,v.

Mv views accu

ne sue,. ec area ciscussec in ne recc=menc.ations were arrivec at following a review of pertinent literature, including NCRP Reper: No. 55, " Protection of the m..w.:. _e e C _' a.nd- _4....he eve.. ^- ' Ra _' a.a s e e

^#

..- - _' a. -

='

locine,n wnlcn was a==rovec or a__-

counc;_, members of the National Council of Radiation Protection and Measurement.

a _, s e h e., c. ciscussions w :n 2

Dr. Eugene Saenger, the Chairman of the committee that prepared the report.

In summary, my views are as follows:

The thrust of the thyroid blocking concept is to protect the gland which is at real risk of receiving absorbed doses of at least 10 rads or =.cre.

This shous, e..ce basec. on tn.e cose es:1 mates ceve_,cpec.

following a major accidenta.1 release Of I-121, and

..k.e

__- =_ = _me.n. s ho u ' " ' e c_ _' ". e. w _' _'._'.. a ' =k '..." _ s l

after such an accidental release.

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u D. _,, u, As Secrcr.ary of U:alth for the Com aonver.lth of Pennsylvania, I with to comment on your April 6 article about the IIealth, 1.ducation and Mcifaro Secretary roccanendinc the administra: ion

.a cf potassium.iod..e to : nose in ne mmod:.. ate v:.c:. nary c:. the LOhrec. iile Icland (0:1I) Plan. - A: the time we received the Secret:ry's-recor.tendation, it seemed inappropriato to admin:. uter the drug uhon there was no scientific indication of any signifi-can radiation.

Accoriing to Secretary Calife.no's own tes:imony before the Senate Subconmittee on Health ar,f. Scientific Research on April 7, the maxinum e::posure to any 2erson was no r. ore than '

05 millirems--a level considered by authoritics in the field to

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As potassium iodide was shipped into ?cnnsylvania', the

' Department of Ucalth was in a constant state of readiness to dir.ributo it to c.11 people in the area, not only those at the o_.m.

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Pro ccti:n, C..'.'.s Durcau of Radiation Health in the Food and 1

Drug Administration

(.".DA),

the Iuclear Regulator.- Comission

(.";C3), the Departson of Tnergy, and some of the country's

^

leading medic:1 soecialists in radiation health.

All agreed

hat we hold the drug in readiness and not administer it unless there was an expectation of i:=ninent expcsure to at least 10,000

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Consecuentiv I fcit c'lic.ed to" advise Governo: hCrnburvh that a

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cer, ziTc. pp.31-245.

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iation Researc.n.

.r,..

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1 e,

2 0.. 34-50.

Commission on Radio _,ogica:, <rotection.

.ne interna:1ona:,

Radiation Protection: Recommendations. Pergamon Press.

New York, 27 January 1977.

National Council on Radiation Protection and.\\basurements.

Protection of the Thyroid b.lanc.

in :.

or_

Releases _o_:Raciolocine: Recor: Ro. -,n,e.

ev ent

2.

National Council on Raciation, 1977.

,,Patien: An:ormation Use or. Satura:ec solution or Potas-sium

.oc... ice (SSr.,,1 ;

or.hyroic..miocxing.,, -ooc. anc l

t Drug Administration, 1979.

Testimony of Secretary Joseph A. Califano, Jr., DHSW, be:. ore :.ne Su.ccommittee on h.ea_,:n anc Scient :..::

1 Research, Committee on Human Resources, United State's Senate. April 4, 1979.

1 1

L.p r o n,.s, r tnur C.,, Ra c,. oolological _::u.:ects or.. Low Doses:

i Implications for Raciological' Protection." Radiation

)

Research, Vol. 71, pp. 51-72 1977.

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p.

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