Agenda 2/18-20/13

1. Questions?
2. READING: LEGALLY POISONED: INTROD!TION" A##$ Int%o
and &on&'usion to !(A)TER 2$ !(A)TER *" A##$ !(A)ATER+ ," -" ./
A##0
3. Distinguis1:
To2i& 3%odu&ts/&ou'd 4e d%ugs o% 3esti&ides" o% so5e indust%ia' &1e5i&a's
To2i& ing%edients in 3%odu&ts/5ig1t 4e to2i& ing%edients in 6oods 7a
de'i4e%ate 6ood additi8e"0 o% in 8a&&ines 75e%&u%90" o% in &onsu5e%
3%odu&ts su&1 as &ad5iu5 o% 'ead in &1i'd%en:s ;e<e'%9.
=di%e&t> 3o''utants/di%e&t e66'uents 6%o5 s5o?esta&?s into t1e ai% o%
3i3e'ines into t1e <ate%.
=indi%e&t> 3o''utants/3o''utants t1at 1a8e ente%ed t1e en8i%on5ent" 4ut
t1en %etu%n 4a&? to &onta5inate us" e.g." 5e%&u%9 in 6is1 76%o5 &oa'-6i%ed
3o<e% 3'ants0" )!@s %e'eased 9ea%s ago %etu%n in t1e 6at o6 4ee6 o% &1i&?en
o% 6is1" o% 6'a5e %eta%dants t1an 1a8e si5i'a% ;ou%ne9.
!(A)TER ,: RE!A#E++ NATION: (OB ECI+TING #AB+ DAI# TO
)ROTE!T !(I#DREN
*. T1e to%t 'a< as =3%e8ention:> Sindell v. Abbott Labs and Mink v.
University of Ci!a"o
,. O8e%8ie< o6 3ost5a%?et 'a<s and 1o< t1e9 se%8e =3%e8ention>/
1andouts: #a<s 6o% (ea't1 )%ote&tion 7,A0 and (ig1'ig1ts o6 a )ost5a%?et
Regu'ato%9 #a< 76%o5 #E+ 1000 7,!0.
A #ost$%arket 'a< 3e%5its 3%odu&ts to ente% &o55e%&e <it1out an9 3%e-
5a%?et testing and %e8ie< o6 %is?s t1e 3%odu&t 5ig1t 3ose.
A 3u4'i& 1ea't1 agen&9 on'9 %e8ie<s t1e sa6et9 o6 a 3%odu&t in t1e 5a%?et
i6 t1e%e a%e data s1o<ing it 3oses %is?s in 8io'ation o6 t1e unde%'9ing
statute.
)ost-5a%?et 'a<s a33'9 to t1e 8ast 5a;o%it9 o6 su4stan&es to <1i&1 <e a%e
e23osed 780-F0G0.
T1ese 'a<s 1a8e a'so 4een &a''ed =3o'i&ingH o% =&o3s and %o44e%s> 'a<s.
T1e9 a%e %e'ated to a 5o%e t%aditiona' a33%oa&1 to 3o''utants.
-. O8e%8ie< o6 3%e5a%?et 'a<s and 1o< t1e9 se%8e =3%e8ention>/
1andouts: #a<s 6o% (ea't1 )%ote&tion 7,A0 and (ig1'ig1ts o6 a )%e5a%?et
Regu'ato%9 #a< 7,@0 .
A #re$%arket 'a< %eIui%es 3%odu&ts to 4e tested 6o% &e%tain ?inds o6
1aJa%ds and %is?s 4e6o%e t1e9 ente% t1e 5a%?et.
!o53anies 5a9 not &o55e%&ia'iJe t1ei% 3%odu&ts unti' t1e ad5inist%ati8e
agen&9 is 3e%suaded t1at t1e9 5eet t1e sa6et9 %eIui%e5ents s3e&i6ied in
t1e 'egis'ation.
)%e-5a%?et 'a<s go8e%n on'9 a %e'ati8e'9 s5a'' nu54e% o6 su4stan&es
7a4out 10G" 3ossi4'9 u3 to 20G0. T1ese a33'9 to #ar%a!e&ti!als'
#esti!ides and ne( food additives.
nde% su&1 'a<s" t93i&a''9 i6 a &o53an9 see?s to int%odu&e a 3%odu&t" it
1as a 'ega' o4'igation to test it and de8e'o3 data su66i&ient to 3e%suade an
ad5inist%ati8e agen&9 t1at it satis6ies 'ega' %eIui%e5ents.
.. T1e To2i& +u4stan&es !ont%o' A&t 71*--1,20.
Ne< !1e5i&a's/Pre%an&fa!t&re notifi!ations: A &1e5i&a'
su4stan&e" not a 3esti&ide" 31a%5a&euti&a' o% ne< 6ood additi8e"
3%o3osed 6o% 5anu6a&tu%e unde% t1e To2i& +u4stan&es !ont%o' A&t
5ust on'9 1a8e" =A## AKAI#A@#E DATA ON !(ELI!A#
IDENTITM" )ROD!TION KO#LE" @M-)ROD!T+" +E"
ENKIRONLENTA# RE#EA+E" DI+)O+A# )RA!TI!E+" AND
(LAN EC)O+RE+.> NO TOCI!ITM DATA I+ REQIRED.
E2isting !1e5i&a's: =I6 In see?ing to 3%ote&t t1e 3u4'i& 6%o5 a
su4stan&e a'%ead9 in t1e 5a%?et unde% t1e T+!A" t1e E)A 5ust
s1o< t1at a &o53ound =5a9 3%esent an un%easona4'e %is?> to
1u5an 1ea't1 o% t1e en8i%on5ent. . . T1e E)A is %eIui%ed to
dete%5ine <1at a54ient e23osu%es %esu't in a %is? t1at is
=un%easona4'e.> T1e agen&9 5ust &onside% t1e 3%o4a4i'it9 and
se8e%it9 o6 an9 %is?s and 4eneNts to t1e 3u4'i& 6%o5 t1e 3%odu&t. It
needs to assess t1e &osts o6 %egu'ation" i53a&ts on s5a'' 4usinesses"
su4stitutes 6o% t1e su4stan&e" and so on" and t1en &1oose t1e 'east
4u%denso5e 5eans o6 %edu&ing %is?s. +atis69ing t1ese
%eIui%e5ents is Iuite s&ien&e- and in6o%5ation-intensi8e.> 7And
a'5ost i53ossi4'e to a&1ie8e" e.g." as4estos.0 Di8e 7,0 to2i&
su4stan&es add%essed in 30 9ea%s.
8. T1e 'ogi& o6 t1e a%gu5ent:
Ra<'sian ;usti&e" as a5ended 49 Danie's" %eIui%es t1at 6ai% eIua'it9 o6
o33o%tunit9 s1ou'd a33'9 to 1ea't1 &a%e institutions 4e&ause o6 t1ei%
st%ategi& i53o%tan&e in ensu%ing &itiJens &an 4e no%5a' 6u''9 6un&tioning
3e%sons o8e% a &o53'ete 'i6e.
Oust 1ea't1 &a%e %eIui%es
o T1at institutions %ini%i)e de#art&res 6%o5 no%5a'
s3e&ies 6un&tioning 49 adeIuate'9 and eIua''9 #reventin"
diseases and d9s6un&tions t1at &an ad8e%se'9 a66e&t eIua'
o33o%tunit9 o8e% a 'i6eti5e.
o T1at institutions adeIuate'9 and eIua''9 !orre!t and treat
diseases and d9s6un&tions t1at ad8e%se'9 a66e&t
o33o%tunit9 at di66e%ent 'i6e stages t1at 1a8e not 4een
3%e8ented.
o Do% t1ose t1at &annot 4e &u%ed" t1at institutions
adeIuate'9 and eIua''9 %aintain #eo#le 7<1e%e 6easi4'e0
as !lose as #ossible to bein" nor%al' f&lly f&n!tionin"
#ersons over a !o%#lete life s#an.
Lan9 diseases and d9s6un&tions t1at a%ise as a %esu't o6 e23osu%es to
to2i&ants du%ing de8e'o35ent a%e Iuite di66i&u't to !orre!t 7un'i?e 5an9
t%aditiona' diseases0" indeed 5an9 &annot 4e &o%%e&ted$ t1us" t1e9 5ust 4e
3%e8ented 7see )%e8enting Diseases t1at A%ise Du%ing De8e'o35ent 7,D00.
T1e 'ega' s9ste5" es3e&ia''9 ad5inist%ati8e o% %egu'ato%9 'a<" is t1e 5ain"
and 3%o4a4'9 t1e on'9" institutiona' 5eans 49 <1i&1 t1ese diseases and
d9s6un&tions &an 4e 3%e8ented in t1e 6i%st 3'a&e.
E2isting 3ost5a%?et 'a<s go8e%ning 80 to F0G o6 indust%ia' &1e5i&a's"
so5e to2i&" 3oo%'9 3%o8ide t1ese 3%ote&tions" <1et1e% t1ese a%e
te!nolo"y$based" a%bient e*#os&re level o% (arnin" 'a<s. Lan9 annua'
&o1o%ts o6 &1i'd%en <i'' 4e 3ut at %is? 6%o5 diseases and d9s6un&tions
t1at &an a%ise du%ing de8e'o35ent as a &onseIuen&e. T1e &1ie6
s1o%t&o5ing 'ies <it1 t1e To2i& +u4stan&es !ont%o' A&t 7T+!A0.
!onseIuent'9" to 4est ensu%e" o% %at1e% t1e on'9 <a9 to ensu%e" t1e
3%e8ention o6 diseases and d9s6un&tions t1at a%ise 6%o5 t1e de8e'o35enta'
4asis o6 disease as a %esu't o6 e23osu%es to indust%ia' &1e5i&a's is to
add%ess su4stan&es t1at &an &ont%i4ute to t1e5 49 3%e5a%?et to2i&it9
testing and 'i&ensing 'a<s.
F. +OLE LAOOR DINA# I++E+ !ON!ERNING )O+TLARAET
#AB+
10. @u%den o6 )%oo6:
nde% 3ost5a%?et 'a<s" t1e state 7E)A" O+(A" !)+!" and so on0 as te
b&rden of #roof to so( a s&bstan!e is to*i!' to establis an a##ro#riate
te!nolo"y +&nder te!nolo"y$based la(s, to %edu&e &on&ent%ations o6
su4stan&es as 'o< as te&1no'og9 &an a&1ie8e" or to follo( !ertain
#ro!ed&res and to establis an a##ro#riate -safe. e*#os&re level in te
environ%ent &nder a%bient e*#os&re le"islation. I6 t1e%e a%e s1o%t&o5ings
on an9 o6 t1ese di5ensions" t1e state 5ust %e&ti69 t1e 3%o4'e5s. T1e
3u4'i&:s 1ea't1 %e5ains at %is?" if a s&bstan!e #oses risks" unti' t1e state
agen&9 satis6ies a'' t1e 'ega' %eIui%e5ents 6o% in&%easing 3%ote&tions and
t1e9 a%e 6u''9 31ased in 7+ee 1andout ,A0.
nde% !a'i6o%nia:s )%o3osition -, t1e state as te b&rden of #roof to so(
tat a s&bstan!e is a re#rod&!tive or !ar!ino"eni! to*i!ant$ a6te% t1at te
!o%#any %&st bear a b&rden of #roof to so( t1e%e is no signi6i&ant
e23osu%e o% e'se 5ust 3ost <a%nings o% &1ange t1ei% 3%odu&t so t1e 3u4'i&
is not e23osed. T1e &o53an9 is %es3onsi4'e 6o% &a%%9ing out 8a%ious
3%o8isions o6 )%o3. -," on&e a su4stan&e is 'isted and at 'ega' %is? 6o% not
&a%%9ing out t1e 3%o8isions. (o<e8e%" t1is <a%ning 'a< does not
ne&essa%i'9 ensu%e t1at 3eo3'e" in&'uding de8e'o3ing &1i'd%en a%e not
e23osed to to2i&ants. It on'9 <a%ns 3eo3'e <1en t1e9 a%e in t1e 3%esen&e o6
a to2i&ant.
nde% #re%arket 'a<s a !o%#any as te b&rden to #rod&!e te s!ientifi!
eviden!e abo&t safety 7and e66i&a&9 in t1e &ase o6 d%ugs0 and to satisfy any
oter !onditions s#e!ified in te la( o8e%a'' to 5a%?et t1e 3%odu&t. T1e
3u4'i& is 6%ee 6%o5 an9 %is?s 6%o5 t1e 3%odu&ts as 'ong as t1e9 1a8e not
4een a33%o8ed 6o% ente%ing &o55e%&e. I6 testing 5isses a to2i& su4stan&e"
t1e state 1as t1e 4u%den o6 3%oo6 to s1o< a su4stan&e is not su66i&ient'9
sa6e and 5ust 4e <it1d%a<n 6%o5 t1e 5a%?et" on&e it 1as 4een a33%o8ed
6o% &o55e%&e. 7E2a53'e: it too? 10 9ea%s a6te% )a%'ode' &aused a %a6t o6
ad8e%se %ea&tions 7e.g." diJJiness" seiJu%es" st%o?es" 1ea%t atta&?s0 4e6o%e it
<as 6ina''9 %e5o8ed 6%o5 t1e 5a%?et.0 7+ee 1andout ,A0
11. No +&ien&e" No )%ote&tions 71-10:
!o53anies (a8e No #ega' Dut9 to )%odu&e E8iden&e a4out t1e To2i&it9 o6
t1ei% 3%odu&ts un'ess ordered to do so 49 t1e .+. E)A 7unde% T+!A0.
Ot1e%s" in&'uding ta23a9e%s" o6ten 5ust 3a9 to 3%odu&e t1is e8iden&e.
!o53an9 Ru'e o6 t1u54: don:t 3%odu&e e8iden&e t1at &an 1a%5 9ou%
3%odu&t. +&ienti6i& studies &an ta?e a 'ong ti5e" e.g." go8e%n5enta''9
aut1o%iJed ani5a' studies a'one" o6ten a 5a;o% sou%&e o6 to2i&it9 e8iden&e"
&an ta?e at a 5ini5u5 o6 . 9ea%s 73%o4a4'9 si5i'a% ti5e 6o% inde3endent
%esea%&1e%s to 5ount a stud90$ &osts in 5i''ions o6 do''a%s.
!o53anies !ast Dou4t on Ot1e%s: +&ien&e/To4a&&o and ot1e% indust%ies:
=Dou4t is t1ei% 3%odu&t.>
!o53anies +1o<ing T1e9 A%e on t1e +ide o6 +&ienti6i& Ange's De5and
Lu'ti3'e +ou%&es o6 E8iden&e and Lo%e studies 7An9t1ing to de'a9
3%o&eedings0: I6 agen&ies a&Iuies&e in t1is" it de'a9s 4ette% 1ea't1
3%ote&tions 6o% 9ea%s o% de&ades 7e.g." T!E 7a so'8ent/neu%oto2i&ant$ 20P
9ea%s0" dio2in 7a 3o''utant/?no<n &a%&inogen$ 2,P0" 3e%&1'o%ate 7a %o&?et
6ue' and 6i%e<o%?s &o53onent/neu%oto2i&ant$ 13P0" 6o%5a'de19de 7an
ing%edient in 3'9<ood and ot1e% 3%odu&ts/?no<n 1u5an &a%&inogen$ 11P0"
na31t1a'ene 7an ing%edient in ;et 6ue'/%e3%odu&ti8e to2i&ant$ FP0 7GAO"
200,0.
!o53anies +o5eti5es ado3t #ess (ono%a4'e st%ategies: !1eat on studies
t1e9 &ondu&t" 6udge t1e e8iden&e. !1ina 4enJene stud9 su33o%ted 49 t1e
A5e%i&an )et%o'eu5 Institute.
T1e 3s1ot: G%eat Igno%an&e a4out t1e To2i&it9 o6 )%odu&ts and T1ei%
Ing%edients 7see s'ides0.
.+. !1e5i&a's: )o'i&ies and !o53anies: @e1a8io% a%e /e!kless to<a%d
t1e )u4'i&:s (ea't1.
12. Lo%e Dunda5enta' Issues:
)ost5a%?et 'a<s a%e too 'ate to )%ote&t !1i'd%en 71.0-1.20:
+&ien&e ta?es ti5e/1as its o<n 3a&e$ t93i&a''9 no g%eat u%gen&9 to
unde%stand 31eno5ena" a3a%t 6%o5 3e%sona' 5oti8ations o6 s&ientists$
4ut it 5atte%s 6o% 3u4'i& 1ea't1.
)ost5a%?et 'a<s 6%ust%ate t1e de8e'o35ent o6 s&ien&e/4e&ause none
1as 4een 3%odu&ed and inde3endent s&ientists o% agen&ies 5ust &ondu&t
t1e studies. T93i&a''9" ta23a9e%s 5ust 3a9 6o% %esea%&1 t1at &o53anies
&ou'd 7s1ou'd?0 1a8e done in t1e 6i%st 3'a&e. T1is is an e*ternality
i53osed on ot1e%s <1en &o53anies a%e not %eIui%ed to test t1e to2i&it9
o6 t1ei% o<n 3%odu&ts.
o An e*ternality is a Qso&ia' o% 5oneta%9R !O+T 7negati8e e2te%na'it90
o% Qso&ia' o% 5oneta%9R @ENEDIT 73ositi8e e2te%na'it90 t1at a66e&ts
a 3a%t9 <1o did not &1oose to in&u% t1e &ost o% t1e 4ene6it.
o E2te%na' so&ia' &osts o% 4ene6its a%e not in&'uded in t1e 3%i&e o6 t1e
3%odu&ts o% a&ti8ities t1at 3%odu&e t1e5. Negati8e e2te%na'it9: ai% o%
<ate% 3o''ution" <o%?3'a&e to2i&ants t1at 1a%5 e53'o9ees o% to2i&
su4stan&es t1at ad8e%se'9 a66e&t ot1e%s. QT1e so'ution/in&'ude t1e
ad8e%se so&ia' &osts into t1e 3%i&e o6 t1e 3%odu&t: =T1e &ost o6 t1e
3%odu&t s1ou'd 4ea% t1e 4'ood o6 t1e <o%?ing5an.>R @ene6i&ia'
e2te%na'it9: 59 3'a9ing !1o3in:s No&tu%nes 6o% t1e neig14o%s ;ust
a4out 4edti5e 7assu5ing t1e9 'i?e t1e50 o% 59 &%eating a 'ig1t1ouse
6%o5 <1i&1 ot1e% s1i3 o<ne%s 4ene6it <it1out 3a9ing 6o% it. 7Do%
5o%e dis&ussion see 33. 232-23*.0
!ausa' %e'ations1i3s a%e t93i&a''9 di66i&u't to identi69" &o53a%e" e.g."
4i''ia%d 4a'' &ausation <it1 to2i& &ont%i4utions to )a%?inson:s Disease"
o% s9nt1eti& est%ogens: &ont%i4ution to 4%east &an&e%.
I6 su4stan&es 3ose %is?s to de8e'o3ing &1i'd%en" fro% te %o%ent at
(i! e*#os&re be"ins ea&1 annua' &o1o%t is at %is? unti' t1e %is? is
%e5o8ed.
!o3s and Ro44e%s #a<s 71.2-1.*0: 6o% 5ost &o3s: and %o44e%s: 'a<s t1e%e
is a s1a%ed and 3u4'i& 3e%&e3tua' s3a&e t1at &an assist t1e &o3s against t1e
%o44e%s. Not so 6o% to2i& su4stan&es. A'so" agen&ies a%e o8e%<1e'5ed"
3oo%'9 6unded" unde%sta66ed" 4adge%ed 49 !ong%ess" e8en 1e'd 1ostage 49
senato%s.
Nuisan&e #a<s A%e )oo% Lode's 71.*-1.-0: Nuisan&e 'a<s 3%o8ided t1e
5ode' 6o% 5an9 en8i%on5enta' and en8i%on5enta' 1ea't1 statutes
a&&o%ding to 'ega' 1isto%ians. Nuisan&es: inte%6e%e <it1 t1e &ondition and
en;o95ent o6 one:s 'and 49 =8i4%ation" 4'asting" dest%u&tion o6 &%o3s"
3o''ution o6 a st%ea5 o% <e''" and Sooding.> +5o?e" dust" un3'easant
odo%s" e2&essi8e 'ig1t" 'oud noises" %e3eated and anno9ing 31one &a''s
5ig1t distu%4 a 3e%son:s &o56o%t o% &on8enien&e. =A 3ond 6u'' o6 5a'a%ia'
5osIuitoes> t1%eatening one:s 1ea't1 <ou'd &ount. @a<d9 1ouses o%
6une%a' 1o5es t1at 3e%tu%4ed one:s 3ea&e o6 5ind &ou'd 4e nuisan&es.
T1ese a%e Iuite di66e%ent 6%o5 t1e in8isi4'e" t93i&a''9 taste'ess"
undete&ta4'e int%ude%s t1at a%e 5o'e&u'es. !onseIuent'9" 3eo3'e a%e not in
a 3osition to ?no< o6 5o'e&u'a% in8asions as t1e9 ?no< a4out t93i&a''9
nuisan&es" so t1e9 &annot %es3ond Iui&?'9 to a&1ie8e 'ega' %ed%ess.