Bailey,  et al
ICF, Inc.
Washington, D.C.
December 1981
         National Technical Information Service

                                        EPA 5 60/TI IS-3 2-00 5
                   VOLUME 3:
               Project  Officer:
              Arnold  M.  Edelman
Preoared under Contract  No:  63-01-6038 for the
         Office of Toxics  Integration
  Cf'fics of Pesticides  and Toxic Substances
       Environmental  Protection Agency
                December  1981
                  SPRINGflElD, Vft 22161









     A major factor that contributes to integration of EPA
as well as interagency activities on chemicals is under-
standing the purposes and major objectives that must be
considered by each statute when designating chemicals .for
regulation.  Because of the numerous statutes and regulations
with differing purposes that designate hazardous materials,
wastes or substances and toxic pollutants or substances,
confusion often results.

     The purpose of this four volume study is to lay out the
key factors required by the statutes and their implementing
regulations that must be considered when designating chemicals
The document serves as a ready reference to those faced -,vith
designing as well as complying with federal regulatory
actions regarding chemicals.
                              Walter W. Lovalick,

   ^-•?.3j.ca. .". .'..:"ar.cas  Designation  is  a :sur v erase  report, of which this is
            isax  to  ese entire series  follows the  Table of Ccntanes  for
           s volume  C3mplemer.
ir::,r.g t::e fn,.^wi.-.g  agencies:
          7b_s volume  C3mplemer.es Volume .; ' s review  of £?A author 1^7 by
        (Z':  Oapartaene of Transportation
        .3'  Fooc  and  Drug Acaiais"ration
        '-»;  L'~itad  States Depareneat  of A.^r. culture

        •,'•:,  %";c.ear Regulator?' Gcemiss .on

        en i/e examined.   The statutory  reviews cover the statutory
.."•-• ic-..;   . s,r:.-' .ativs h-story, court  ciaes and settiesier.es that  ara relevant
;  35::". -jri..-.;."' 3  authority co issigr.ace hasarcous  chemicals.  The  regulatory
,v »\«  -  „-. =  c ,  -.-.ci  reijulsri.'cs pr-tr-ulgitad u.r.»er each statute, and, sere
,£.. . .!..:«..," i  t r e  criteria '..ssi to '^issignaea c:iesccals or products  rar

   T .£• atirutorj  and raguls.tory rev.a'-s  ire tinalvc^.d  ir:. Volume  1  and the
•.=:.,_• _-!.-•  ™-i=,, -\a;ad  are '.r-cluced  ^3.  the  ^atr^x caapris:j.g Volume  -.
                                             I V

                          TABLE OF  CONTENTS
                             VOLUME  III



          Introduction                                                  1--
          Caselaw Review                                                1-5
          Section 3(3) and  the Significant  Risk Test                   i-i:
          Section 6(b)(5) and Feasibility  in General                   1-1:
          The Standard of Review:   Section  5(f)                        1-2:
          Overview                                                      :
          Chemical by Chemical Analysis                                 1-
          The CSKA Cancer Policy                                        1-55
          Generic Hazard Identification  and labelling                  1-53

          Explosives and Other Dangerous  Articles Act
          Hazardous Materials Transportation Act
          Dangerous Cargo  Act
          .Bulk Flammable and Combustible  Liquids Act
         ' Ports and Waterways Safety  Act   •
                                 '^l"**'Ti^KT  A *****    "«^ **»«^ ( MI^^T^ **
                                 .Ai.CN  ACT --  .\icv-*^i. _ji:
          Explosives  and  Blasting  Agents
          Flammable and Combustible  Liquids
          Flannaabie Solids
          Organic Peroxides
          Corrosive Materials
          Comprassad  Gasas  (Tlitsmabie  and Ncn-Flaacaola)
          Etio logic Agents
          Radioactive Materials
          Other Regulated Matarial (CRM)
          liazardcus Wastes,-  Hazardous  Substances, and CRM

drips' Store  zr.c Supplier                                       2-32
Bulk Solid  K£~£rd.eu.s Material;  nv '•",,•<,;;=»_                       2-23
Bulk Licuid Dangerous Cargoes  :•-' .?£<•>,,                         2-3-
Dar. serous Cargoes or. Waterfront. 'r,;-;^l»- -,±z,                     2-26
:'ci.d  "rug,,  and r.:?::iet-.r. Act  cf 19 33
     Statutory .,'ri;9,-ia and Factors for Regulation

     I.1.;or3it:.rt: Reauirec  for Approval
     •-C "ancatcry Reverting Requirements

     £*ac,,tcr7 Cm.ria ?-nd Factors for Reg-latior.            2-19
     Ir.f crssat :.:r,  \s-qu.red  for .--pproval                         3-21
     .-c 'U.-d£ ::""/ r r.ocrt ;_ng Rec-_: ecoents
C;jl';r Ac^L'ive <1..'ner.r^xer.ts  of  19:."

     S.atutcry Cr.tsria and 7acto:s for Regulatiori
     Inforaation Required  fcr Approval
     No Mandatcr" Reccrt^;',^ Racu.r/einents
     Caemizal  S-cs-ar.ces  v-overac
     Infcrsarisr^ Required fcr  Approval
     Ho Masia-srv Re;.cmng  Recu^reaienrs                       3-25
jr-g Aner.dments c£ 196".                                         3-27
     rheiical  Substances  Covered                               3-2"
     I~fcr3ct.:.cr. Re rjir'ii fcr  Approval                         3-36

                              TABLE OF CONTENTS

                                 VOLUME III



              Aniaai Drug Amendment of 1963                                3-33
                   Chemical Substances Covered                             3-38
                   Statutory Criteria and Factors for Regulation           3-39
                   Information Required for Approval                       3-iO
                   Mo Mandatory Reporting Requirements                     3-<*l
              "poisonous or Deleterious Substances" and Other Previsions   3-<*2
                   Poisonous or Deleterious Substances                     3-^2
                   Poisonous or Deleterious Packaging                      3-^2
                   Medical Devices                                         3--2

         FOOD, DRUG AND COSMETIC ACT -- REGULATORY REVIEW                  3---*
              Introduce ion                                                 3 ~ --
              Pesticide Chemicals                                          3--3
                   Chemical Substances Regulated                           3-<-3
                   Designation Criteria                                    3--9
              Unavoidable Poisonous or Deleterious Substances              3-56
                   Chemical Substances Regulated                           3-36
                   Designation Criteria                                    3-56
              Food Additives                                               3-53
                   Chemical Substances Regulated                           3-56
                   Designation Criteria                                    3-55
                   GXAS Food Additives                                     3-60
                   Pesticide Chemicals on Processed Food
                     as Food Additives                                     3-62
              Color Additives                                              3-6^
                   Chemical Substances Regulated                           3-6-
                   Designation Criteria                                    3-6-
              New Drugs                                                    3-66
                   Background                                              3-66
                   Chemical Substances Covered                             3-66
                   Approval Criteria
              New Animal Drugs
                   Chemical Substances Regulated
                   Designation Criteria
              Medical Devices
                   Substances Covered
                   Acoroval Criteria

;~CIVCT2 IN3PE-.ION  A.JT -- STATUTORY  REVIEW                    --1
 Ir.tr eduction                                                    *-'.
 ^ v*« ^ "L.JLHc£s wCversc                                              <^ — ^

 ? *pc:'t_ns Requirener.ts                                         i-5

:?C,I'"s."TS INSPECTION  ACT -- RE3ULATCRY REVIEW                   i-9

                                                                    . ^
;N "K.~"."-I\~rON'  rirKArlNG ATT --  E'TATYT'.'R'f REVIEW                5-16

;:~iz:-.  \V.ODTJCT SAJITY ACT -- STATUTORY REVIEW                    5-20
 2a;;,(.a"r3unc                                                      5-20
 Suhs~i:r.cis Covered and Statutory  Criteria                     5-21

'JiL K-iZARIiCUS  SU3STA.MCI ACT ••-  REC-ULAT3RY REVIEW               5-22

 ?r'3CJcts 3aclarec ~c be Hazardous Substances                  5-2?
 L-..jiing sr" Strong Ser.sirizers                                  5-28
 Prsc-acts Requiring Special Labelling                          3-il
 'Jannsd Hazardous  Substances                                    5--1
                         v'i I I

                              TA2LE OF CONTENTS
                                 VOLUME III

              Introduction                                                 5-45
              Regulatory Criteria                                          5-45
              Regulated Substances                                         5-47
         FLAMMA2LE FA3RICS ACT -- REGULATORY REVIEW                        5-50
              Overview                                                     5-50
              Standards                                      -              5-50
       '  CONSUMER PRODUCT SAFETY ACT -- REGULATORY REVIEW                  5-51
              Intr cduct ion                                                 5-51
              Regulatory Criteria
              Regulated Substances
              C?SC Action on Asbestos
              C?SC Action on Lead Paint
              C?SC Action on Chloroflurocarbcns
              C?SC Proposed Action on Uraa-Foraaldahyda
                Foam Insulation                                            5-61

         ATOMIC ENERGY ACT -- STATUTORY REVIEW                             6-2
         ATOMIC ENERGY ACT -- REGULATORY REVIEW                            6-4

                      '.varvLr'  or  bspra-ae  ^ou.r*  .•io.J.ins;s  is

                                   -'.':. jr.ol z g*? ,
                      Heal-. ::_ S-.anaaras  fsr Tex, c  ar.d H«L:ardcas  Sucs~.ir.cas
i!C-',I3IT  1-4          CSiy\_'_s ;_ I!asirr.atior.Cri"sr I.?, t'cr  Tc.xic  ir.d
                      Th',rt.agn Car--r.cger.s  Des izr..'~ac  .is  Toxic  ^r.d
                                  ^"_'jg ____ j.r.d Cosnetic Act  - Ma'sr
                      Css-.e: -cs  AC~
                                  f t-a  ,-;od. HTMS.  ar.d  3jsae":i"  Act


                     Overview cf Cgr.suaer  Prccuct Safary Cancissisr.   5-32
                     Substances and Articles  Desigr.atad l'-der  the      3-29
                     Fedsral H2_zardcus  Su.bs~2-r.css .^ct

                     Subs~£r.ces Des igr.sxeci for S~ecial Packagir.g       5 ->*6
                     Recui-rener.ts - ii  C~R 1'OC.li
iI-Z-IIBIT 5-3          Asbestss Products  -  Regularsr*' Chrsnclogy         5-58

iXHIBZT 5-9          Lsad-3ased Pair.-:  - Reg^larsry whrcr.olagy          5-6C

^I!ZiI2 IT 5-10         Chlorsflurscarbcns - Regula-cr/' Thrcr.slcgv        3-61


     The Occupational Safety and Health Administration  (CSHA)  is  responsible
for the implementation of the Occupational Safety  and Health Act  of  1970.   The
legal reviews and analyses that follow do not necessarily  represent  the
official position of CSHA or the Department of Labor.   Moreover,  this  aateriai
has not been officially endorsed by the £?A as its ur.cerstar.ding  of  3SKA
authority over toxic materials.  The contractor, 1C? Incorporated,  is  solely
responsible for ail analyses and interpretations.  The  .-atarial  ir.cluo.es
statutory and regulatory events through February 1.5, 1931  only.

     The Cccupafionai Safety and Health  Act  (GSH Act) becane law en December
"9, 19"0.;  Gn« "urpose of the CSH  ACT. is  to authorise ar.forsanie.nt of occu-
pa~. icn.il sjnsiy and health standards  "to assure  safe and healthful working
conditions :o.- vorkir.g sen and wcnen.'1*

     An occupational safety and health st incard  as definad by the GSH Act  is
''a standard viich requires conditions, or  the adept ion c: use of one or ncra
practices, zeans,  methods, operations, or  processes, reasonably necessary  or
appropriate t; provide safe or healthful -inploytaent and places of
esployt:ant. 3  There is no definition  of  toxic or aa'ardous substances
included in tr.e GSK Act.

     T;:r---se sections of the CSH Act  authorise OSHA to promulgate occupational
safety and health standards to control toxic and hazardous substances.

          '1   5 act ion Si" a', required  CSKA to quickly promulgate as
               r-aaltn stancards existing national consensus
               i'.^r.dards  and established "ecarai standards.1*

          ^-^  Section 6Cb'. expressly authorizes CSrlA to "promul-
               gate, scdify or revoke any occupational safety or
               health standard" if  the Agency caterair.es that a rule
               should be  issued in  crder to  serve the "objectives"
               of the Act.
     ;?ur, 1. 51-596,  29  U.S.C.  §  651  et sec.

     *':SH £c- Section  1,  29  U.S.C.  §  651.

     3CSH Act Section  2(3),  29  C.S.C.  3 652.

     w 'The tars  'national consensus standard'  seans any occupational  safety
and healtr. standard  or aodification thereof which (1),has been  adopted and
oronulgatsc by a  nationally  recognized standards-producing crga:cizatic:i under
procedures wharaby  it  can be determined by the Secretary that persons
ir.tarastac arid affected by the  scope  cr provisions of the standard  havj
reached substantial  agreeaent or. its  adoption, j_2H-'as forsulated  in a manner
vr.ich  ifforded an opportunity for  diverse views to be considered  and  ^3j_has
,-een J 23 igr.s:,ac  as  such a standard by the Secretary,  after consultatic- wvth
:-h-r  itprttrirta raderal 2;sncias,"'  (CSH Act Section 2(9))

     '''".:•= -;s.r^   established  -"ederal standard'  aeans any operative occupations
? if sty  and healtr. stancarc established ;y ar.y agency  of the ",'nitad  States  ar.c
:  i%s«nt".T IT.  effect,  or csntamad  in any Act of Congress in forca on  tee cats
0-  ?ni ct~e" t  - f  tr.is -ict.'"  (CSH Act  Secticr. 2'. 1C))


          (3)  Section 6Cc) authorizes GSHA to establish an eaer-
               gency temporary standard to protect employees from
               "grave danger" resulting from exposure to "toxic or
               physically harmful" substances.

    Section 6(a1.   In accordance with Section 6 (a) cf the OSH Act, CSrLA pro-
mulgated an initial standards package on May 29,  1971 which incorporated ex-
isting federal safety and health standards as well as national consensus stan-
dards.  The incorporated federal standards were primarily those standards
originally contained in the' Valsh-Healy Public Contracts Act.*  The national
consensus standards adopted by OSHA were issued previously either by the
American National Standards Institute or by the National Fire Protection
Association (36 PR 10466);   ANSI Standards were issued primarily to deal with.
product liability; NTPA for fire prevention (i.e_. , property protection),
worker safety and health were, secondary considerations.

    The initial standards package designated about 4QG chemical substances as
air contaminants and adopted threshold limit values  (from the national consen-
sus standards) as exposure standards for them.  See  29 CT3. 1910.1QCC.

    Section 6(b).   CSHA has designated for regulation twenty-three toxic and
hazardous suostances under Section 6(b).  The statutory criteria for detamn-
ing which chemicals are designatad for regulation ara the "objectives" cf tne
Act.  These objectives include:   "To assure so far as possible every working
aan and woman in the Nation safe and healthful working conditions and to pre-
serve cur human resources."

    Section 6(b) directs GSHA to express the standards "in tens cf objective
criteria and of the performance desired".  Standards developed under Section
6(b) may include provisions for permissible exposure limits, action lavels,1
labels or other forms cf warning to apprise employees of hazards, suitable
protective equipment, control procedures, monitoring and measuring of employee
exposure, employee access to the results of monitoring, and medical
examinations at no cost to employees.  In addition,  Section 3(c) cf the CSK
Act permits standards to prescribe recordkaeping requirements where "necessary
or appropriate for the enforcement of the Act or for developing information
regarding the causes and prevention of occupational  accidents and illnesses.'1
     The Walsh-Healy Public Contracts Act of June 30, 1936 prohibits haz-
ardous or dangerous working conditions for employees engaged in the- perfcr^;-
anca of contracts with the United States Government.  Other fadersl standards
incorporated into CSHA's standards package include operative occupational
safety and health standards in effect on April 23, L9~l, and established by
the Department of labor pursuant to Section 10? of the Contract Work Hours ar.c
Safety Standards Act, as amended (40 U.S.C. § 333); Section 41 of the long-
shoremen's and Harbor Vcrxers'  Compensation Act, as amended .'33 U.S.C. * 5-1);
the Service Contract Act of 1965 (41 U.S.C.- § 351); or pursuant to the Na-
tional Foundation on the Arts and Humanities Act (20 U.S.C. § 951).

    'An action level triggers monitoring and aedical surveillance require-
ments prior to exceeding the permissible exposure limit.

     ,.~5 -uostantive requirements  :or  nea.tr.  stanaarzs  are specified in
S = ct;.?,: £ b'. ;5  where the  level cf protection that  standards aust provide is
£.-- plamec.  As Section 6(b)(5) statas,  CSrlA,  ''in  promulgating standarcs
csa__--g •-:.-- toyic materials  .  . ., shall  set tne  standard v.iich r.ost
atecuata."  assures, to tns  extent  feasible, on tne  basis  of the best available
e~. -sancs, t.-.at no ezployea  wi.l suffer material  lapairaent of health or
f_unc_tiona.  cat a city even if such ecployee  has regular exposure to tr.e hanard
dea.lt vitn  cy su.cn standard for the pence cf his working life" (asp has is

     Tr.i3 statutory provision  also stipulates the  factors CSI-iA aust consider
-.'her cave lot ing health standards.  These  factors  are:

         '    "the attainment  of the highest  decree of  health and
              „.£ -„ ____  „_,•__ C__ ••_-	1  .-,"»

     Judicial review of the health standards also has clarified the aear.ing of
"feasibility" as a criterion for developing health standards.  The asbestos
standard decision confirmed GSHA's authority to consider economic and techno-
logical feasibility in setting standards.  laThe U.S. Court of Appeals for
the Second Circuit (in reference to the vinyl chloride standard) decided that
consideration.'  of technological feasibility were not limited to exposure
control devices already developed and in use.  The Court assarted that stan-
dards could require imprcveaents in existing technologies or require the de-
velopment of new technology.11  Feasibility is discussed in sore detail

     Section 5(c1 .   Several 6(b) rulaaiaking proceedings establishing
permanent health standards began with the development of emergency temporary
standards under Section 6(c) (e.g., the asbestos standard).  Emergency
temporary standards take effect immediately upon publication in the Federal
Register and are effective for 6 months or until superseded by a permanent
standard or stayed judicially, whichever occurs first.11  ETS ' s have not
been extensively used by CSHA for controlling toxic substance exposures in the


     In the area of toxic substance regulation, GSKA workplace standards have
been a significant source of litigation.  Recently, the Supreme Court
addressed QSKA's authority in this area and the kinds of risks it can
regulate.  Other cases have concerned the role of economic factors and t.-.e
aeaning of "feasibility".

     Court review of OSHA standards has centered on three orovisions of the
CSH Act:

          (1)  Section 3C3)--Definition of an "occupational safety
               and health standard."

          (2)  Section oCb*1 (5) --Rec.uireger.ts for promulgation of
               stancards dealing with "toxic materials or harmful
               physical agents"; and,

          (3)  Section 6(f;--The review process for s. challenged
               CSKA stancard.

     The Supreme Court's benzene decision will be reviewed in ccn;unction witr.
the discussion of Section 3(3).  The different holdings of the Justices will
be reviewed as summarized in Exhibit 1-1.  Cther key cases will se ciscussec
as aoorocriate.  These cases ara suimanzec  in Exnioit 1-2.
      '•'• ScciatT cf the Plastics  Industr^. Inc. v. I SKA
in tms review.

                              EXHIBIT 1-1

                   CVERY'EW C? SU?',£MZ CCUT" HCL2""NG3
                        IN ITS BENZINE DECISION
7iic. be:isene regulation is  invalid because CSHA  didn't    Stevens
fxrst :^ake a  finding that  a "significant risk"  '         Burger
e.xis-ad,                                                  is t swan

Y.V! be::.~a~e rsg'^latic^ is  invalid because CSHA           Powell
d,,CLr. ~ sicw 3  "reasonable  relationshi.?" berweer.
_~s iot-s anc  bar,ef its.

Tb.s barj:ir.s reeu.aticn is  ^r.valid because Congress       •xehnquist
-t£v^ ^^r*.." to'ca—«."  i^ace^uate ^uicancs on new to
set a stancarc.

The Dari^sne. regulation is  valid and CSKA is not          Marshall
racu-red to find either  a  ''significant risk" cr  a        Brennan
reasonable cost-benefit  relationship.                    white

CSI^. ~3.~ regulate  risks  that are not subject to          Powell
quantification on  the basis of the best available        Marshall
evidence.                                                 Brennan
                                                          Vhit e





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                       ;-  rice  ::as unexpectedly  fumec out tc oe 5 £e<7

                       ?,rA  ."ar^st,   ^evertheless,  it is tne basis  for  £
 :-:,': icr. , .:•  ciarmes  a  vorKr_ace stanc,£.r:i £.3  one  requiring work practices
  - .' «~"."  ~ :~,i i." a~ E .

      r. &£... t :i i:u 1 eco!client  anc. olsces or eirlcvsent."

 .-.  * se  v.15", the Circuit  Courts have interpreted  Section 3(8) as giving
 ~~r..'i^er it  .a discretion in adopting protective  workplace standards.   For
 .a,  ir,  tas.  c,.sse of the  cotter, oust standard,  industry argued that aedical
 i,l;.™c? i^:;-L!: would procsct against aateriai  ir.pairaent of health.   The
 - ,~".::.', ';:..•"- cf Ap-pealr.,  however, helc: tr,£t  -SKA has the discretion to
 r.;t  tr.-=,  •;=.!:• an  exposure ccntrci str-'.tegy  >.g  ,  control technology,
             _•'_   ^	v°.-    ^^- ^-, f'   "^- .. — . ~   «   •*        *..    ,*'
 -  -j;.  :',•--:  -e  ;y C3MA aa  a pri-sar™ ::>&„::*  ,: providing safe workplaces.

 "•':v-'e:  5action 3'8} vas  interpreted in s. verv different fashion by the
 ;.~',,-~  >.':c:t of Appeals in its review of CSnA's benzene decisicn.
 ;-;'••  t'-.d ',', S, Supreme Court,  hearing the benzene  case on appeal,
 .i,^:.er  ,,i.-.s :. senzene  stancarc.   wni.e section  .(s;  wa.s tne cstensio-e
  •!  •:;• Cf-iis :on.  the.  7ifth Circuit's "reascnibli  relationship"
 brns:_•: test was not affiraed by the Supreme  Court.   Instead, a
. _ fica: 7 r s tc  ": thresnold  requirement WAS reac  fr-~  the ohrase
 .-.'v. c_gn v* _-3view  the  Derivation or the significant risk recuireme-t  in
 .  3«lcw, we first caution the reader tiaat tnis  case is a weak precedent.
 -ic<..rrvr t.tir:or.s were  filed and a majority  of  Justice.s did not agree  on
-_on.;lfe f-r invalidating the standard (See Exhibit 1-1).

 *':;a':  ^oes ~~z& phrase  "reasonably necessary or  appropriate" in Section
 3^ar"   7.SH.A argued  that Section 3(o) iraooses no substantive restriction
 s« .~  is a merely definitional provision; thus, it allows any rational
,.rrd   Industry  argued that, as held ay the Fifth Circuit Court of
    ::-. ?. tr.it trie  terns   signiricant  rerers  tc  tae crcsasility or  an
 t!_ rut-ess  not  the severity, nor the nunber  of  individuals affected.
 ':" -  / 'J; 1 units  OSHA's  iuthoritv to "material" impairments,  in  any
   }'..r :r.~rDc;r = . the number of individuals affected is not germane  bec.ause
 •:•:,-••  "c -.'-.",=  to  regu'.ate  hazardous chesicals  encountered by only  a
 sc :'.•.::.;&: •-.:  wcrxers  (e.


Appeals, "reasonably necessary" means chat the standard's benefits must bear  a
reasonable relationship to its coses.  The Supreme Court held that Section
2(3) requires OSKA to first find that a standard be "reasonably necessary and
appropriate" to remedy a "significant risk" of material health impairment.
This is termed a "threshold" finding because it must be satisfied before CSI-1A
can proceed to develop a protective standard.

     Vhat is a significant risk?  The Court explained that if the odds are one
in a billion that a person will die from cancer by taking a drink of chlorina-
ted water, the risk "clearly could not be considered significant."  On the
other hand, if the odds are one in a thousand that regular inhalation of gaso-
line vapors containing two percent benzene will be fatal, the risk could raa-
scnably be considered significant.  The Court, however, leaves a vide gray
zone between .001 and .000000001.  Most toxic substances risks will probably
fall right in this gray zone.1*  This formulation suggests that agency
regulations may be challenged as inadequate if they do not reduce the
significant risk to a one in a billion chance of fatality.  Moreover this
approach works best for unidiaensional health effects.  It is not immeciately
clear how different types of health effects risks (e.g., cancer deaths, birth
defects, chromosomal changes) are to be aggregated to determine if they
constitute a significant risk.  It is also unclear whether Total exposures
(including occupational exposures and exposures to other toxics in the
environment) should be considered.  There ara tr.us several unanswered

     The phrase "significant risk" appears nowhere in the CSH Act.  This
threshold test was derived through the application of the following c.-.ain of

          (1)  A standard must be reasonably necessary or appropri-
               ate for workplace safety and health (§ 3(3)).

          (2)  A standard can only be necessary or appropriate when
               there exists an unsafe or unhealthful workplace or
               the risk of one.

          (3)  "A workplace can hardly be considered 'unsafe' unless
               it threatens the workers with a significant risk of
               harm" (Justice Stevens).

          (i)  Therefore, a standard can only be necessary or appro-
               oriate when it can racuca 2 significant risk of harm.
      ' *7or example, under the Claar. Water Act, the Z?A cetermines the quan-
tities of hazardous polluting substances whicn may be harmful to the puoli:
health and environment if spilled into the waters.  The I?A accomplishes  tr.is
using a worst case scenario combined with a significance  factor of a cr.e  in  a
million risk of fatal cancer.  The Supreme Court's opinions say encourage seme
legal challenge to this methodology.

     .:.: :  r£iScr.ir.z,  vr..icz z,as £ certai.-  attract iOijic, may  nor,  .icwever,
,,,;•» "..:;"..i tc  ezta:: _ish £ r.arrir of  raf°_ty for t:.e protection of workers, ir.

:.-'.:.. :.:.:: rei.?ec  senr itiviry cf susceptible individuals anc possible multiple
v ..-fr.c-  of  ar. increased risk"  due to benzene exposures  at or  below 1C  pom.
".:-;  '.. :.ur'  criticized the agency  because CSKA saae no finding that exposure to
 ~cr_sr.e  : t  1C  ppc nad ever in  fact caused leukemia.  But  the Justices
ex;.:cit]y  did ncj. express an  opinion on "the more difficult question of what
 -.ict-i..  ,: 3-.i---itaticns would warrant a conclusion tnat significant risks are

      Th",  plu-al_ry opinion, however, did not seen to take into  account o::
ur.der'itar.d  the scientific-medical aspects of the case  when  it demanded CisKA  to
snow  so3E: escirical evidence documenting a leukea.ia  risk  at 10  ppra.  That  10
ore  e>roo;ure  level had been established by CSHA only in 1971. .This would be
 ar.  insufficient tiae period to  evaluate the effectiveness of the standard.   • '
Leu.-tecia  can  appear nine to 20  years after exposure  to benzene  has ceased.
      •s":':urie,r. of proof"  is  a  legal concept with  important ramifications.
Tre  party with the burden  is generally at a disadvantage.   The courts  have
3CDcti;ufe£. placed the burden  on the agency issuing the standard and other  tines
r.ave  tlaced ~ne ourcen on  challengers.  There  is  no  settled rule of  law.

Many of benzene's health effects are irreversible and often  fatal  (e.g.,
aplastic anemia).  It is far too soon to know exactly how safe the  existing  1C
ppm standard will prove to be, particularly since QSHA  is directed  by  Section
6(b)(5) to set standards which assure no satariai health impairments will
result even from regulated exposure throughout working  life.


     The Court in Industrial Union summarized Congressional  thinking about
the feasibility requirements included in the CSH Act:   "Congress does  not
appear to have intended to protect employees by putting their employers cut  of
business—either by requiring protective devices unavailable under  existing
technology or by aaking financial viability generally impossible."1*

     The following review of feasibility is divided  into two sect ions--one
discussing technological feasibility and one discussing economic feasibility.
This coincides with the treatment given feasibility  by  the courts  in their
discussions of the.issue.  However, no court has indicated that an  OSHA
standard would be invalidated solely because it was  deemed eccnsaical'.y
infeasibie.  Furthermore, the OSK Act treats ''feasibility" as a single
concept.  Therefore, "economic feasibility" and "technological feasibility"
should be viewed as two separate considerations which CSHA addresses under the
general feasibility requirement.

     Technological Feasibility.  Technological feasibility is a crucial con-
sideration in setting an occupational safety and health standard.   Sines the
CSH Act does not set guidelines for determining what is feasible,  the  concept
has not been completely fleshed-out, but the broad outlines  are established.
In The Society of the rlastics Industry, Inc. v OSHA,17 the  Second
Circuit Court of Appeals seemed to interpret technological feasibility as a
broad conceot which entailed at least three components:
      •* Industrial Union, oo. cit. at p.  1629.  It  is  interesting  to  r.cta
some dicta in ATI-CIO, v. 3rannan, 3 CSHC  1320,  1323  (3d Cir.  19") whicn
tempers this statement:  "We co not question  that there are  industrial
activities involving hazards so great and of  such little  social utility that
the Secretary would be justified in concluding  that  their total prohibition  is
proper if there is no technologically feasible  method  of  eliminating  t.-.e
operational hazard."  While the CSH Act places  some  limits en what standards
can require from a tachnological and economic standpoint, not all  acts dealing
with human health ars so temperate.  Regarcing  the  Clean  Air  Act Azer.cmer.t3  of
1970, one court has noted that ''Congress  aada it clear t.-.at  consideraticn  cf
economic cost or technical feasibility wara a.ways  to  be  subordinate  to
consideration of puslic health."  N1CC v, i?A,  -.39  ".Id 39Q,  -11--12  i'15"-;.
See also, Regulatory Analysis Methccs:  A Review of  ?ast  Health-Related
Efforts,  "Appendix 3:  Legal Issues ~o± Regulatory  Analysis'  ;lraft;   137
Inc., 1979), for a discussion of the feasibility and standard of review issues.

          '*    ^t.gmeermg tecnno—Oirv

          *    personal protective  gear.

 ,nyl ir.lcrice was —feasible because  engineering controls could never acnieve
 ve 1 rpc level.   The Court reasoned that:

          "    the industry underestimated  its  technological

          •    tr.ere were work practice  controls  and personal pro-
               tective gear which supplement  tne  engineering con-
               trols, anc whicn could  be combined to "definitely"
               attain tne goal of the  lowest  detectable level.'"'
  e court statad:   -n tne area or  sarety  tne  secretary is not restrictec 07
  e status quo.  He nay raise standards  which  require icprovetaents in existing
  onnclogies or which require the development  of  new technology, and he is not
 imited to issuing standards based  solely  on devices alreacy fully devel-
     Tr.i Third Circuit, in ATI - Z~ 3  v  3rannan, ' '  asserted that GSHA could
 ~r.sio.er tacnnolcgical feasibility  with  regard  to non-toxic hazards:  "If  the
 ocretary -sy c::::sider technological  feasibility with respect to the eli=:.na-
 -L^in c « n
any appropriate technology which. "looms en today's horizon.""3  Technologi-
cal feasibility, therefora, "implies consideration both of existing  techno-
logical capabilities and imminent acvancas in the art."2"

     In American Iron and Steel Institute, at al. v OSHA,15 technological
feasibility was further explained.  The Court again relied on the  industry's
experience in decreasing exposure lavels and indicated that this trend pointed
to the industry's potential technological capabilities.  The Court was con-
vinced by evidence accumulated by the Secretary that the new PEL could be
achieved if the industry would apply itself to the task.1*  In any event,
the Court made it clear that the certainty of technological feasibility need
not be absolute:
     23 _Id.,  at p. 1329.  Note, however, that the Fifth Circuit has used
its benzene decision (American Petroleum Institute, at al. v. 2SHA, 531 ".Id
^•93 (1978)) as authority to limit what nay be required of employers in this
respect:  "The Secretary may promulgate a standard requiring employers to
implement technological methods not yet developed out loosing on the horizon
only if the Secretary can show by substantial evidence that the emplcyner.-
conditions imposed by the proposed standard ars reasonably necessary to
provide safe or healthful places cf employment," Marshall v  V?st Point
Pepperell, Inc. 338 F.2d 979 (5th Cir. 1979).  This reasoning was -pnelc on
other terms by the Supreme Court, 	 U.S. 	 (13SC).

     2k Id.  The concept cf "imminent advances" indicates that time is an
important factor--affecting both technological and economic feasibility.  A
standard with a five-year lead-in period might be considered technologically
feasible, whereas the same substantive standard requiring immediate compliance
might not be feasible.   Similarly, a lead-in time might bring within the realm
of economic feasibility a standard otherwise infeasible.

     15377 ?.Id 315, 6 CSHC 1-51 (3d Cir. 1573) (coke even emissions).

     ISThe PEL was based on results from tests at one cf  the industry's best
facilities for limiting exposure levels.  There also was  such testimcny
highlighting "innovative technology currently in the experimental s.age
readily adaptable to old(sr) facilities."  Id., p. 1-53.  Vhile this might be
considered suppor- for che general conclusion tr.a- technological feasibility
encompasses PELs based on industry-leader experience, t.ie ccica oven case
involved a unique situation:

          (T)he coke even incus try is unusually r.omcgeneous ,  nearly
          all facilities conform to the sane basic tasizn.
          Therefore, the control capacilities of tne incus try leacer
          fairly approxima-ad waat otner facilities could.
          accomplish.  Tnere are faw instances in which the
          homogeneity cf the regulated industry is so pronounced.

Berger and Riskin, "Economic and Technological Feasibility...'' " Ecology lav

                  citne evicar.r  tr.st  a particuar  safer™ and health
                  •_ - — p ~ ^. - e      — 3 ~ - -^ ^ *-.;.-—;:   ^-  * ••- * a 3 ^ • '•- " o  Q —
                 -*~~~B.~«. ._ *.  ,  ,  .. V. „.._*.._,. ,, „_,»„.»._ ^  ..... .. v« . w .. _ , W .
               The  Ccurt nctec  tnat uncer appropriate conditions,
               v--:ir.ces vers available when  eng.~^.feerir.g controls
               ;.j;;i  .'»r:; pricrrr.es  s.c r.s~ trirxg  abcur the riicuired
 yr. : or s _•„-.« v;.:;. drsclj.^3 certsir.tv i.iat ever;." l;;.rzj in the  ir.iu.str" ca:: meet
,::i ;r. .ir..,ir;    1^  crc-»r "..,; caz3s.straf.e f aasi;ili:y,  r.oveve::,  CSHA nu.st show
•:•'.. i^rrex:' "-^chnclcgr has "conceived" ci strategies or devices that ar

     Economic Feasibility.  It appears that no court has requirec  in  explici
terms that CSHA must consider economic factors in determining feasibility.
It is clear, however, that OSHA considers economic factors to be crucial  in
the promulgation of standards, and that the courts expect the sucject to  oe
traated by OSHA.  In all practicality, then, the issue of the economic effec
of a standard oust be treated by CSKA.

     Perhaps the simplest explanation of feasibility was given by  the Court
Industrial Union:  "(I)t would comport with common usage to say that  a stan-
dard that is prohibitively expensive is not 'feasible'."z'  This is in
keeping with the Court's interpretation of the CSH Act's legislative  history
that "practical considerations can temper requirements."3'  Industrial
"Jr.ion established the tone of subsequent judicial discussions or ecor.cmic
feasibility.  The salient principles espoused by the court are:

          •    A standard can substantially increase production
               costs without rendering the standard infeasible.

          •    A standard can be economically feasible even if it
               adversely affects profit margins.

          •    A standard can result in the "economic  demise of an
               employer who has lagged behind the rest of the indus-
               try in protecting the healt.i and safety of employees
               and is consequently financially unable  to comply vitn
               new standards as quickly as ctr.er employers."

          •    If economic demise assumes industry-wide
               proportions, economic feasibility is called into

     The Court in ATI-CIO v 3rennan endorsee as "a proper construction" of
the CSH Act, the Incustrial Union court's practical constraints on feasibil-
ity.31  The Court in AFL-CIO intimated that the economically infeasible
standard is characterized by "massive economic dislocation."  The  court sug-
gested that economic infeasibility would result in widespread evasion of  a
standard, and that enforcement difficulties would be insurmountable   Thus,
economically infeasible standard would not be effective because compliance
could not be enforced.
       -?9 7.Id -67, 1 CSHC 1621, 1639 (emphasis added).

     ; 3 Id.  Cne commentator suggests that ''the concept of economic  feasi-
bility as a qualification to the mandate for aosolute safety vculc accear tc
encompass only the most extreme kond of ccsts--tncse so large as to  put sig-
nificant portions of entire industries out of business."  R.S. Smitn, The
Occupational Safety and Health Act (All:   Washington, 3.C. 15*5).

     3 :;30 ~.Zd 109, 3 CSHC 1320, 1330.

                                                            cne court  rerers
."ecreTiry ere  -_":cuj~ry  groups  producec studies  01  tne co

                to adequately protect employees from the hazards
               associated with coke oven emissions.J!

It is fair to suggest that balancing came within the rule that "practical
consider at iocs can tamper protective requirements"  laic down by the Ir.dus -
trial Union Department court.  If so, it would be one of the factors CSHA
could, but was not required to, consider in deciding whether a standard  is
economically feasible.  The court concluded that it had no basis to find that
OSKA had not inquired into the economic feasibility of the standard, or  that
the standard was infeasible.  The Court also gave extra credence to the  "nitad
Steelwcrkers'  support of the standard, reasoning that the workers had as much
to lose as anyone if the standard was economically  infeasible.

     Snrmary cf ?easibility:  Technological ar.d Zcsncaic

     The concept of technological feasibility, as developed by the courts,
allows GSHA considerable latitude:

          •    An occupational safety and health standard can be
               technology-forcing.  The standard can go beyond the
               technological status quo and require currant technol-
               ogy to be improved and new technology to be developed.

          •    Technological feasibility is net achieved strictly
               through engineering controls, but encompasses work
               practices and personal protective gear.
               The courts will not require that a standard's
               technological feasibility
               before it is promulgated.
echnological feasibility be absolutely certain
     15 Id., pp. 1*59-1460.  Although the Suprase Court has net directly
addressed the economic feasibility issue, it has granted review and heard oral
argument in the cotton dust litigation.  The Court has fccusec its raview on
the economic issues.  STo court, to data, has held that CSKA ~ust conduct a
formal cost-benefit analysis before it promulgates a standard.  In the cotton
dust litigation, the D.C. Circuit seated that "Congrass concluded that the
benefits of health protection warranted the expense of an affective stan-
dard. ...  Further, cost-benefit analysis wculd not necessarily improve agency
health and safety determinations.  These techniques require the expression  tf
costs, benefits and performance in often arbitrary, measurable ca~s.  Tr.ey
say hie a assumptions and qualifications in the saemmg oo-activity of
numerical estimacas.  Especially where 3. oclicy aims to trotact the healtc  anc
lives of thousands of people, the difficulties in comparing widely dispersed.
benefits with sore ccncentratac and calculable costs cay overwnelm tne
advantages of such analysis."

                                        st  our~£s£  casset i>6 tlaced os  isdi*
 ic-icatac that economic feasibi.ity  is  set cestroyed by:

          '    cs increase  is production costs;
               ;: De  -se oeacraarsc  or  ecoscs. _c is: easi.~i_i~y is a  ssassiv«
eccrcni- c:is loca:i=n" cf "he  iscusiry  affect id by -he siancard.  Tiiere  arst so
cu.er Dsusas set by the courts,  out factors  which cas be considered  is
ac..i_ti'js "o these listed above  are:

          •    Effect os csfflpetitics--fcreign, ir.tar-isdustry, and
               i", -." 2 • isdus t r1-*;  =.sc

          •    Er.fcrceaest difficulties .

jS.-i.-.  .3 a-..parsr.tly sot limited  by  these  factors,  asd oey consider other
factcvs i:: additics to or is  lieu  of these f actor.'".   Econcaic  feasibility,
tserezo-s. does set raqu.irs the fisascial burdes to be Eisi^al or eves
rea.jir-s.oli. but it does require the burdes to stop short of causis.g  a -as.»ive
cisru-tio:. cf trie tarset isdustrv.
     '.so vtasdard cf  review  is  a  legal tern: which refers to the  test  whics
  •. rts apply -z agency  actions  such as regulating toxic substance  exposures.
  urti us« d_; rarest  tests  for  different situations.  Is general,  a  "factual1
  teriisatios is reviewed under a different test thas is a "policy"
               Tie substastial  evidence test is usually applied  to
               adjudicator?  proceedings or icraal ruieaiaking. 3 '

               Tae questions arising in these situations are  usual.ly
               f actual  is  nature.   A definition cf "substantial
               evidence" was gives recently by the Fifth Circuit--
               Euastantial evidence is "such relevant evidence as  a
               reasonable  zind  might acceot as adecuate to suoport  a
        Industrial Usion  DesartTest ^  ATI-C:0 v_^ Hodgson.  A99  F . 2d i67,  :


               conclusion."}'  Thus, when an  administrative  action
               (such as a regulation) is based on  a  factual  record,
               seme facts contained  in  -he  raccrd  aust  support  -he
               action taken aver,  -hough other facts  in  the  record
               would support a totally opposite  conclusion.

          •    The arbitrary or irrationality test is usually
               applied to 'essentially  legislative tasks,"--i.e.,
               policy determinations.  That is,  a  workplace  standard
               cannot be arbitrary or irrational.31

Another way of locking at these two  "yardsticks'* was  articulated by  the C.C.
Circuit Court:

          •    A choice based on  detarainable facts  must  be
               supported by evidence in the record.

          •    A choice based on  policy judgments  aust  be
               explicitly based on considerations  which the
               adainistrator found persuasive.

     Which standard of review is  chosen is  theoretically  important,  because
each denands that different requirements be set  by the  record on vhi:h an C5KA
standard is based.  In the final  analysis it  is  net  the title appliec to t.ia
     57 Marshall v. West Point Pepoerell,  Inc.,  333  ?.2d  579,  935  (13:9).
Another articulation  is that  evidence  is  "suostar.tial"  when '"from it 'the
evidence) an inference of the  fact nay be  drawn  reasonably.'"   Aaencir. Ir:r.
and Steal Institute,  at al v.  CSHA,  i77. F. 2d  325,  6  QSHC  1-51,  1-55  (2-re. Cir.
1973).  The Court was quoting  Schvarz,  Administrative Lav 595  i'197")    Cr.e
cocaientator has suggested a practical  view of wnen ~o apply substantial
evidence review:  "The ability to apply the substantial evidence  rule
obviously depends upon the degree to which a  particular decision  is
susceptible to  evidentiary development."   Taylor,  Donald,  "Reasonable
Xulesaking Under CSHA:  Is It  Feasible?"   9 S:.  Mary's  lav Journal 215, 223

     31 Industrial Union Decartssr.t. AJ1-CIC  v.  Hodgson,  1 CSHC 1621,
1627.  The agency is  to aake  its policy determinations  in such "'a aanner
calculated to negate  the dangers of  arbitrariness  and irrationality  in  the
foraulaticc. of  rules  for general application  in  the  future','1  Industrial
Union lepartaent, op. cit., p. 1=27, ind  Society of  the Plastics  Industry,
Inc. v. CSHA, 2 CSHC  1-96, Ii93, (2d Cir.  1975)  (vinyl  chloriie) ,  anc 3.
legislative task aust be carried out "in  a aanner  reasonable ur.car the  state
of the record. . ." Asterican Patroleuna Institute,  at al.  v   2S?IA, 6  CSHC  1959,
'1961  (5th Cir.  1973)  (benzene).   Nota  tnat  the  5t-  Circuit r;
interpreted Section  5(f)  of  the  CSH  Act  to  reouire  application of the
"substantial  evidence"  standard  to CSHA's policy (or legislative)
determinations  as well  as  to  its  factual determinations.   Texas Independant
Sinners  Assoc.  "  Marshall,  3  CSHC 22C5, 22C9-221C  ,'3tn Cir  '.93C ,

                •-re  -ourt ,  ouc :.- = suoscar.c = ;: c.:=  rs.-iew  taat is irapcr-
         ~..e.  courts  nave  giver. scze guic.sr.-s =.s to  the  characteristics o:: a
         , v» -policy  aecerzinaticr. anc a factual dete— ir.ati:;n.   These charac-
         : '.~:~ circus see  c-elow.

         -.:" ~'e~a~inatior..s .   CSrli policy c.ersrz^r.acicr.s  were deened tc e;:is"
         T .^;;"»"i^£  suiis c;  s i,C"iiS~ nns :

               Tner.  s,  particular questicr. is =n the "frsr.tiers of
               aci&^~_fi:  cic'vedge  and the c.a~a  relevant to such a
               qufestion  is  msufficient  tc sa^e a fully i;ifcrrned
               factual detaniziatics." a pclicy situation exists;*'

          *    W"rer.  z. standard is set and "reliable  data is not
               currently available with respect to the  precisely
               predictable  health effects cf various  levels of
               exposure" to scae hazardous subftance, the final
               setting of  a permissible axpcs^r's level  is a policy
               cr.cics to b« ^c'cie by the Secretary .**  The Secre-
               tary  aay  rely on "rsspectasle cpinisc" that such
               Ifrvels do exist. ij

     Ti_; rfi=OiT.it:.cn that  policy decisions conf'-und the application of  tests
 : i :.it:.:".,-i lly spil.eJ tc factual detarsinaticns ':.,a.s  been rscagnised in
 •;; -later- areris ctaer  than occupational safety and healtn:

          Loot:in.£ to the future, and conasandec by  Congress to aake
          policy  a  rulemaking agency necessarily  deals less  with
          "a' icentiary"  disputes than with normative conflicts, pro-
          • a-.. i:,ons fron  :.cperfect data, experiments  and simulations,
          as.-cg.ted predictions, differing assessaents of possible
          ris&s , and the like.  The process is quasi* legislative in
     *" JLr-   CThe  Court  also quoted the Supreme  Court's  language in the
Persian jasis_Araa Rate  Case.  290 U.S. 747, 311  (1968):   "Where existing
-et.-cccl-:gy or  research  in a new area of regulation  is  deficient, the agency
r.etss3&r".ly »n;oys oroad discretion to attempt to  formulate a solution to  the
best cf  its ao:.l;.ty on the basis of available information.")

     "'" IT- '  Sse-.aTv sf  the Plastics Industry, og.  cit. ,  p. 1502.

     ": 3yr.tr.etic  _3rg£nic Cheaical Manufacturers Association v. Srennan,
506 ?.Cc'32--, csj^t.  cenied, 422 U.S. 386 (1973;; 2  CSKC  1402, 1-C6  (3rd Cir.


          character, and one will search  it  in  vain  for  those inter-
          mediate "fia.din.gs" of  fact which mark the  midway point in
          an adjudicator's  linear march from raw evidence  to single,
          ultimata conclusion.*3

     "actual Determinations.   If the Secretary's "task consisted primarily of
evaluating data and drawing conclusions"  from that data,  the court will apply
the substantial evidence test.*"  OSKA's  determinations  were characterised
as factual, subject to the  substantial evidence review test, in the following
S Z.~Tii&'C iCHS •

          •    whers the hearings regarding  revocation cf  a.
               standard had been rich in  statistical evidence
               submitted by parties on both  sides of the
               controversy;**  and

          •    where the Secretary's determination had oeen based
               upon '"overwhelming  scientific evidence'" including
               "chemical analysis and various epideoiological
               studies;" testimony  by the Assistant  Director of
               N'lQSK; a 1370 report to the Surgeon General entitled
               "evaluation  cf  Environmental  Carcinogens" by the ad
               hoe Committee on  the Evaluation  of Lew Levels cf
               Environmental Chemical Carcinogens  (summarizing the
               opinions of  numerous experts), and the majority
               resort of the Secretary's  Advisor-/ Committee. *5
     ": Amoco Oil Co. v. E?A,  501  7.2d  722,  725  (D.C.  Cir.  197-)  (leac-free
gasoline).  C'as'es involving  other  regulatory agencies  confirm this  viewpoint
(see,  for example, The  Superior  Oil  Co.  v  7ERC,  363  F.2d 191,  231  (5tn Cir.
     *"  Industrial Union,  op.  cit.,  at  p.  1=27  (asbestos).

     *s  ATL-CIO v. 3rannan.  530  7.22,  109,  3  CSH 1320  (3d Cir.  19751    This
case involved  revocation of  the  "no  hands  in die'1  requirement  of the
mechanical power press  standard.

     14'  American Iron  and  Steel  Institute,  at al.  •-•.  CS'-IA,  5~~ 7 2c  325.  :
CSKC 1-51, l-55-l-5cj  (2c Cir.  1973)  (cotca  ovens)    This  standarc,  r.cwaver,
arrears  to be  an exceotion in  regard to the  detail contained in the  record:
"CSHA  took a  long time  to  prepare  this  standard,  held unusually extensive
promulgation  hearings,  and compiled  an  extraordinarily detailed record en
these  issues.   If OSKA  begins  to set acre  standarcs,  it  will r.ot .tave as  r.uc.i
time and resources to  devote to  any  one hazard."   Berger,  Jeffrey,  anc Siskin,
•Steven,  "Economic and Technological  Feasibility in Regulating  Toxic  S'lostancas
'."near  the Occupational  Safety  and  i-Iealtr. Act,"  ~  Ecology Law Cuartarl", 155,

         -. r.cu.c  ae  nccac,  nowever , tr.at  wm.e tne reccrc .lav  ccr.-c.ir. great
".<-"-,.;.-. a. cut  a  decision,  it still 227  involve sclicy  'uczner.ts  and r.Ttr2"
     Ir. iucraary,  1:1 industrial Ur.ior..  tr.e Court sade an interesting
ccservs:;.:,:, wr.-cr almost hac, tae  appearance cf an institut isnal- cuid cro
~;£c.   -SKA 'nac  txp-mded its ir.foraa.1 hearings ~~ ir.ci-ce  aleaer-.s vrzica
"i--,-"ic-i  -, ^r;r-=  c,a»£iled reicrd  (i.e.,  easier fsr £ ccar*  :o  apply the
     rr*. .£.  ?r.  i6Tj.ce tast; tsan szncri"  rscuirec 37 tae wlsr.  Ac*.   ..ie c;urt
t ."„•_-••-  ' i;  ?"';ill7 the par"; of "«iicc~  c~.d res»rn~~ en our par"  cc show a
^.^rri.ra;'.=  : li.xiri.iiy,  anc ro ba  always  rind.ul tr.sr st laast  scae
", ig~s .a. iv6  "uc.~:ar.;s carjuc- ba ancncrsc  secu.rel"." ar.d sclelv  ir. deccr.5~r2.2le
Lict '"*  <~^£.-  seems re be acknowledged,  rnerefcre, is ina: 3£rIA  will tr? ~o
£.sse:-2le  as  c.c;:ple~e a record as passible sc a raviaw ^.g csur* ' s  task will  oe
fac»li'a::=d,  ar.d  thar the ccurt will  give cue regard -.o the Secretary's pclic;.
r.at.i-—,ir..iticr:a  wr.thcut requiring too  auch irsa tr.a ra^crd  cr  acccrcing false
pr&iicia:.. to  the  facts provided^   "Vhat we are entitled to at all events is a
:.i-Qf~'.  .denti:;ication by trie Secretary ...  of trie reasons why  he chooses to
r'o'Lcw c-.f  c;::j.:rss rather than another."*5
     * "i.s  tie  iiuprene Court has  indicated ir. another regulatory area, what
,i .--.-CTti.r t  is.  the nature of the  Decision:

           ".o  the extent tnat factual  ceter~:inaticn.s were  involved in
           *i n*2  ...cr^ir^ission s decision  to  graricizatcier incst existing
           .crab maticr.s, t.iey were  primarily of a judgmental  or pre-
           o.i:tive nature ...   In such circumstances, conr.plete :ac-
           tu.l support ir. the record  for the Ccaanission' s  judgment
           :,r  prediction is net possible or requir-ed; "a forecast of
           tee  iirection in which future public interest lies necess-
           sirily involves deductions  based on the expert  knowledge
           cf  t:.e agency."  FCC v.  National Citizens Cocas,  for
           Broadcasting, i36 "J.5. TT5,  815-14 (1573).

Sir.-e cf  the  factual determinations to which the court  referred were "whether  a
c-.vestiv.ure  retuireaent would result  in trading of stations  with out-of-town
owners;  vnetr.er new owners would perform as well as existing cross owners,
either  :...-.  tne  short run or in the  long  run; whether losses  to existing owners
would  result  froa forced sales;  whether such losses would discourage future
investment ir.  cuality programming; and  whether new owners would have su::fi-
tienT  working  capital to finance local  prograaiaing."

         Ic. ,  £:. D. 1638.


     This paper reviews the Occupational Safety and Health Standards  for  Toxic
and Hazardous Substances promulgated or proposed under the authority  of Sec-
tion 6 of the Occupational Safety and Health Act (QSK Act).  The  paper will:

          •    discuss OSHA's approach to designating chemicals as
               toxic and hazardous substances;

          •    identify the chemical substances which have beer-
               designated for regulation as toxic and hazardous

          •    review the health standards established by CSHA; and

          •    soecifv the basis for the standards.

     In accordance with Section 5(a) of the CSK Act, CSHA  initially  designate:
i-00 chemical substances as air contaminants and promulgated  exposure
standards for them (29 CFR 1310.1000).  Appendix A  lists the -00  chemicals  anc
their threshold limit values in units of milligrams per cubic aeter  of  air

(23/3 ) and parts per million (pptn).  Exposures to  substances are limited  to
acceptable ceiling concentrations and/or 3-hour tiae weighted average
concentrations.  See the CSHA Statutory Review for  a discussion of the
authority for this action.

     Through Section 6(b) proceedings, CSHA designated and promulgated  health
standards for these twenty-three  substances:

           (1) Asbestos
           (2) --Aminodiphenyl
           (3) i-N"itrobiphenyl
           (i) Alpha-Xapthylamine
           (3) 3eta-Mapthyla=ine
           (6) •*-•*'- Methylene bis  C2-chloro-ar.ilme; '
                   uirsnenio or tne L-W»~ dc- -ere not  laet  ov  tne  -»-—  ..etnv-ene
                   jie) standard.  The Court found that  CSHA  viol at ec, the  ti~e
                    outlined in Section 5fb^ of the CSH Act  because  tne  --<-
                   .loro-aniline} proposed  rule vas puolisned refers  tne  acvi-
                   submitted its rape".

                    r.v.  —r.-crc2£:

           (13)  Il-Acetylamincf lucrene
           ^1~)  ^-Dimethy 1 as inc an c benzene
           '„'.;   N'-v;.::rosociaethylan:ine
           'It;  "'invi Chloride
           (17)  ^Inorganic Arsenic
           ,1£)  leac.
           (19)  3 ens en e  (vacated by the  Supreme Court, T/2/80)
           (1C)  '"oka oven emissions
           '*la; "c-ton susr  in  cacccn  gir.s (vaca-ed)
           ' H. *)  L £**'**' b"*cc3C"" 3 ~ c'n" c^oc^ co^ne f D3*!!^ "5
     The stiT.dirds were pronuigatec  as  Subpart Z -- Tcxic and Hazardous  Sub-
s"=r.jer c: T'.tle Zq Ccce. cf Federal  Regulations.  CSHA alsc has proposed
~. *=.'.~~. s"5.r.i£,r=3 :~r bsrylliun,  sulfur  dicxicie,  trichlsroetryleae, toluene,
=-ii-cr__= .  =?.c. a r'iv.iod asbestos  standard.

     Exn^bit 1-2 pjssents a chronological  review cf the regulatory actions  in-
volved '*~~z -S-iA s health standards.  The  date and Federal Register citation
a.; = induced for each emergency  temporary  and permanent standard promulgated.
Ir. dccir.cr. , the date and citation  for  the proposed beryllium and asbestos
standards are listed.

     Zxnibit I -<- sussarices the  various criteria used by CSI-IA to designate
chemual : -ostancea for regulation.   CSKA  relied on two primary criteria:

          ['.]   'iealth Effects
     The three types cf health  effects  considered were acute health effects,
chronic health effects  (non-carcinogenic),  and carcinogenicity .   In seme
cases, CSKA relied only on  acute  health effects to designate a chemical sub-
stance for regulation  (e.g.,  cotton dust in cotton gins) whereas  in other
cases, CSKA relied solely on  evidence of carcinogenicity of a chemical  (e.g.,

     Lxhi::it 1-- also  lists the types of data, i.e., epidemiological ,  ani:ial
bioassay. short-terra assay, or  chemical analysis, on which OSHA based
detertiinations that a  chenicai  substance was a human carcinogen.

     Vhtn carcmcgeiicity of  a  chemical served as a criterion for standard
setting, CS'-lA followed  a general  policy that if safe exposure levels for
carcinogenic substances could net be scientifically determined, standards were
established s.~. tne lowest feasible level.   In determining the lowest feasible
leve., CSMa consicerec  economic and technological feasibility for each
c'r,snr.i:a_ substance regulated.

                                                 22CHI327 1-3
                                              OCC::?V:ICNAI. SATST? AME  »;AiT3
                                     rea TOXIC xso tASAasccs SCSSTAMCSS

May 29, 1371
Jectnoer 1, 1371
June 7, 1372
My 2, 1373
January 29, 1974

April -, 1974
Cctcsar 4, 1374
3«cacs«r 1974
-eoruary 5, 1975
Cctooer 1, IS"1!
Cctcaer 5, 13~S
CctcEer 17, 137=
Cctooer 29, 197 =
Noveso«r 24, 1375
August 20, 1975
Cctooe: 22, 1975
May 11, 1377
Septemoer 9, 19"'"
January 17, 1373
fteeuaey 13, 1973
Marcr. 17, 1973
May 5, 1973
Jcr.e 23, 1973
Jun« 23, 197S
Cctcser 3, 1973
Novemoer 14, 1973
January 22. 1330
July :, 1330
August 12, 1330

Nevflffioar 17, 1330

January IS, 1331
Januarv 29, 1331
                                                                                 f«d«r»i R
400 \s.c .'»fif aainjn-  standards  prcmul^acta
         latrg«nc-/ TsBootjry  Standard
         ?«rain«n: Standard pccoulqaced
          Temporary  Standards  :uu«d  for  14
                (including 4 ,4 'M«tr.yi«n«-oi» (2-eftlorianili^e
Standards sromuigatad  lor  14 Carcinogens
    (including MBCCA)
'Hay I Chlarid* iS^r^cncy Tsaporary  Standard issued
Vinyl CSlarid« ?«raan«ne Standard promulgated
M30CA Standard vacated 3y  »i;*h  Circuit Court off Appeals
Standard  reproposed  Jar MSCCA
?ropos*d  Sevisions  to  Asnestos  Standard
Toluene Standard proposed
3«ryiliua Standard  proposed
Trichloroetaylene 3tanda;d proposed
sulJur :isxid« Standard proposed
M3CCA deleted from Carcinogen  Standards
Ccne 3ven Smissionj  ?eraan«nt  Standard prsmuigated
benzene Sa«rgency Temporary  Standard  issued
ISC? -:n«rsency Tsnporary Standard issued
Acrylonitrile laec^ency Temporary Standard issued
3«nzene Permanent Standard prooulgated
:3C? ?«raanent Standard prcaulgated
Inorganic Arsenic Permanent  Standard  promulgated
Cotton lust ?«raianent  Standard  promulgated
Cotton Cust :n Cotton Si.is Standard promulgated
Aery lonitr lie Periianent Standard promulgated
lead Peraanent Standard promulgated
CSHA Cancer ?olicy  promulgated
Benzene Standard invalidated =y  Supreme Court
"Candidate" Carcinogens list puoiisned ander  1/22/30
   Generic Carcinogens Policy
Cotton 5 in Ring Standard invalidated by ?i:t-1  Circuit
   Court  o; App«a.s
Hazard Identification  (laoeiing) Standards proposed
Proposed  I^aoel.ng Standard vi^r.dr-iwn
36 " 1^466
15 ~5 1220"
37 r?. 11213
23 r* 1:923
33 ?3 2 "5 5

39 ??. 12342
29 ~3 35393

40 T?. 4922
;C -"3 -47532
43 r? 46235
40 "3 ;3314
43 rs 49022
40 "?. :4J2:
41 TH 35134
41 rs 4S742
42 ~ 22515
42 r? 4533 =
43 r"R 2336
43 "? -313
43 r3. 11514
43 ?s 13424
43 r^ 2"25C
43 "3 27413
43 ??, 43572
43 r^ :3352
42 f?. :332
4a " -412
4S ??. _1C2C

•5.     X      X      X
                           s      —       0          t  -^       a
                          ~      2      ~i         	w
                           ^       5      -r  *      1  -      t
o          >        I



     This section, reviews each chemical substance designated 27 CSHA  for  regu-
lar ion as a toxic or hazardous substance under Section 6(b) of the CSIi Ac..
The criteria used by OSHA to designate the substance for regulation and t:.e
rationale'behind each standard is discussed.


3asis for Designation

     Asbestos2 was designated for regulation under Section 5(b) because t-is
substance at high concentrations is causally related to asbestosis (lung-
scarring).  At the tine of designation, it had been veil established  that
asbestcsis was a major cause of disability and death among workers regularly
exposed to asbestos dust.  A British Occupational Hygiene Society Study1
suggested that the incidence of asbestos is would be markedly diminished by the
reduction of occupational exposure in factories and during end product use.

     Reports also indicated that workers exposed to asbestos during factory
production of asbestos products and in their subsequent use wars at increased
risk of developing several types of cancer, including lung cancer and
mesothelicma.  The specific concentration level below which exposure  to
asbestos was safe was disputed.  Because of the long lapse cf time between
onset of exposure and biological manifestations, CSHA did not have accurate
measures of the levels of exposure which occurred 20 or 20 years ago  and
subsequently gave rise to cancer.  The relationship between extent of asbestos
exposure and risk of asbestos-associated cancer had not been defined.  As a.
result, QSHA proposed asbestos exposure levels to  prevent asbestos is and
"hoped" the permissible exposure levels would be restrictive enough, to also
minimize asbestos-associated cancer."


     A standard for occupational exposure to asbestos was included in the
initial promulgation of GSKA air contaminant standards (26 7R 1C5C6 ,  May  29,
1971).  This standard was derived from a 1965 federal standard issued ur.cer
the Valsh-rleaiy Public Contracts Act.  The standard established an exposure
-  .  *  Asbestos  includes chrysotile, ancsita, crccidolite, trsmolite,
anthophyllite, and actmolits."  (19 C7K 19 i: . 1CC1 (a) (I/; .

    3"Hygiene Standards for Chrysotile Asbestos for the Prevention cf
Asbestos is", British Occupational Hygiene Society,  1966.

    "Proposed Standarc for Occupational Exposure to Asbestos, Cctooar  1=,
1973, C-C ?R -76.;:).

                                                         .,„ —, \
                       -----  , o_ — — - — -  - «..»_.  _  ~*^ .„ _ —«J _— - ,
                     o c
.-  aaoestcs risers .-reatar mar. ; n:i.:rcr:s  ir.  .ar.g'tn;  per zi__i_iter
     Ir, £ iccria-'^Cr witr.  Section  5 [c)  cf  -he CSH Act,"an anergsncy"t'e.T.pcr3ry
s"_3r.i£rz .=E  first issued  for  asbestos  (36  Fs. 22257, December 7, IS"1),  This
"ancard was  .~asec on CSHA's determination  that employees were exposed  tc
"grave car.ger" free exposure tc  asoescos.   A permanent standard was prcmulga-"
r.a- en Jure ", 15 "2 (2T  FH  11-12) which  established ar. 3-hcur tiae-weightad
average  '7-'»/  c:3r.c?:^trat.ior. exposure  iisit  of five fibers (lor.g-er rh.sc  5
r.: ,:rrn:.etar3 ~  per  curie centir.erer of  air, arid s. ceiling lir;itatic-. against any'
exposure ir. excess sf ten  sucz fibers per cubic centimeter.   Furthermore, the
star.card ;r=vicea that tr.e  S-hour 7«TA be reduced to tvo fibers, effective July
1, 1?"5.  The regulation specified  engineer:.r.§ methods ano vork practices for
coctliancs vith the standards.   In  addition,  cautionary sign specifications
anc labeling  requirements  were incluaed  in  the regulations.

     The N'ICSH Criteria  Document  for  asbestos had pointed out that nost
Tiedical opinion was divided between advocating a two-fiber standard or  a
five-fiber standard.5  3SrlA decided to promulgate the acre restrictive
rvo-fiber standard, with a  ceiling  value of 10 fibers/oc as the permanent
standard ifter Ju'.y 1, 1976 because:'

          •    there rust  be one  standard governing exposure to
               all varieties of  asbestos and all workplace exposures;

          *    setae employees  with  regular  exposure to asbestos
               had already  accuaulated great doses of asbestos
               fibers, due  to  higher  levels of exposure in the past;

          •    it appeared that  levels of exposure which might be
               safe with regard  to  asbestosis night not be safs with
               regard to aesothelioaa;

          •    "he statute  required the  protection of every
               employee, even  one who sight have regular exposure to
               asbestos  during a  working life which Eight reach or
               even exceed  -0  years;

          •    the conflict in the  aedical  evidence should be
               resolved  in favor  of the  health of employees.

     An intena standard (permitted until July 1, 1975) of five fibers  wa.s
instituted to give employers a transitional period in which to sake the
:,:ecas5arv arrangements for complying  with  the acre stringent two-fiber
    5''RecoE3end.itions  for  An Occupational Exposure Standard, for Asbestos  by
    Nancnal  Institute for Occupational Safety and Health", 1971.

    '?rear;ole to the  Standard for Ixocsure to Asbestos Dust, 37 FE  11213,


     Prior to its adoption, GSKA considered the feasibility of -ha standard by
identifv"ing those industries which would meet compliance difficulties  (e.g.,
textile, manufacturing, and marine installation).   After evaluating the extent
of redesign and relocation of equipment necessary for these industries tc
comply, OSHA determined that the transitional five-fiber standard would
"provide all employers a reasonable time to comply" (37 7R 11319, June 7,
1972) with the two-fiber standard.  Furthermore, OSKA determined that
technological controls and appropriate work practices would provide the "best
protection against asbestos fibers feasible" (37 FR 11319).

     QSKA proposed revisions to the asbestos standard in October 1573  (~0 jTR
i7652).  To data, no final revisions have been promulgated.T

     The proposed revisions were based on new information concerning the toxic
effects of asbestos and on the experience gained by CSHA through three years
of enforcement and administration of the current asbestos standard.  Specifi-
cally, OSHA identified the widening spectrum of cancers associated with
asbestos exposure and the various manifestations of asbestos disease in
individuals exposed to relatively low concentrations of dust as the primary
factors necessitating a revised asbestos standard.  The proposal intended t =
rafocus the primary function of the standard from preventing asbestcsis to
reducing the incidence of asbestos-associated cancer, particularly

     The proposal, if promulgated, would revise the definition of "asbestos''
in the present standard.  It would add to the existing definition of
"asbestos" the phrase "and every product containing any of these air.era.ls".
This proposed change reflected CSHA's "concern for the morphology and  toxicity
of the regulated substance rather than its geologic or mmeralcgic origin"  '-3
TS. i7552).

     OSHA also proposed to lower the 3-hour exposure limit (TWA) to 0.5
asbestos fibers per cubic centimeter and to lower the ceiling exposure to 3
asbestos fibers per cubic centimeter.  The proposed change vas based en CSHA's
determination from new medical and scientific evidence that asbestos vas a
human  carcinogen.  As a human carcinogen, there is no known safe exposure
level  for asbestos.  Consequently, "there should be no detectable
concentrations" in the workplace (CO FH ^7652).  However, CSHA is required to
consider technological and economic factors when setting permissible exposure
levels so the orocosed standards were established at the lowest feasible level.
     NIOSH racentlv recommended a 0.1 asbestos fibers oer cubic centimeter
3-hour exposure limit.  CSHA is examining this racocnendaticn to saa  if  it  13
technologically and economically feasible.  This information is from
discussions with CSHA's Health Standards Staff.

     The chemicals  listed  in  Exhibit  1-5  were designated fcr regulation under
Section : ';, z: the CSH Act because CSHA  coiisicerac them tc be carcinogens.
Ar.jzr.er c,r.emical, *-i'- -ethylene  bis  (2-chloro-aniline),  was designated fcr
regulation because  cf  its  carcinogenic potential,  bur was  deleted from tt.e
reflations on August  20,  1976  (^1 ?R  2513«i)  following a U.S. Court cf Appeals
remand c: the standard tc  CS?LA  (See Footnote  1) .

     l-.aii.ri review  dccuaents  submitted by N'lOSH  to CSHA for each suspected
carcmcgen were mstruaental  in  CSHA' s aesignation o: the  fourteen chenic.als.
The hazarc review docucents sv.CTiariaec health effects of t-.e suspected
carcir,cgens including  experiaental aninal and epideaiologic, data.  The
ir.ferr£t;.cn found in each  document vill be reviewed below.
     .^e cnez:.c.3.-s are aerinec  in  tae  regulations in terns cr Chemicai
Abstracts Service Registry Numbers  (CAS  nuabers).1   Exhibit 1-5 lists th«:
CAS nuabers corresponding to  each  checical  :iaae and the section in the Code cf
?adaral r.sgulations which defines  each chemical.

     The cesi.rr.iticn of  twelve  of  the  chemicals is  derived from a list of
c3.rcmog?.c.s orscarsd bv  the American Conference of  Government Industrial
Hygienists  (AC^IK; .  CSrlA selected all but  one of the substances listed by
ACC-IH "IT: order to take  advantage  of the work and judgment of that group".'
CSHA did not  Designate dimethyl sulfate  even though it was on the AC3IH list
Because documentation of its  carcinogenicity was  inadequate.1*

     ~^ addition to the  chemicals  on the ACGIH list, CSHA designated alpha-
r.apthylan:ir;e  because:

           (".}  alpha-napthyiamine  had  frequently been found, in
               industrial experience and in epidemic logic studies.,
               to be carcinogenic,  and

           (2)  experimental animal studies  demonstrated alpha-
               napchylaaiine's independent carcinogenicicy.
      '"or  one  chemical,  3,3'-Dichlcrobennidine (DC2) ,  CSHA designated  it:;
salts  in addition  to  the substance classified 'under the Chemical Abstracts
Service Registry Number.

      'Preamble to  Occupational Safety and Health Standards for Carcinogens,
35 FR  27.36,  January 29,  1974.

          In  its  designation of the carcinogens, CSHA  excluded solid or liquid
     aixtures  containing lass than specified percentages  of  the listed substances.
     products  which are considered useful in industry  and even in cancer researcn,
     and  about which the record contains very  little  information" (29 73. 3739).

           Mixtures  of seven of the carcinogens  containing less than 1 percent by
     weight  or volume are excluded from the standards.   Furthermore, solid or
     liquid  natures containing less than 0.1  percent  of six other designated
     carcinogens are excluded.  The exclusionary  percentage for mixtures of  these
     six  substances is 0.1 percent (rather than 1 percent) because "these sub-^
     stances are known to be potent huaan carcinogens".   (29 TS. 3739, see ixr.ibit
              T'W j ..*• a^n  f a »•-• •» i^
              S2JZ3IT 1*5

iccer.s Hesicnatsd  as  Toxic and Hazardous Substa
Onder Section 5fb) of tne OSH
Chemical Mama
4-Aaincdipher.yl (4-ADP)
Alpha-Napthy lamina (1-NA)
3eta-Na? thy lamina (2-NA)
Methyl Chlorcarethyl Ether
2,3' -Cichlorocensidine (DC3)-/
bis-Chlorcmethyl Ether (3OE)
Ethyler.eimina (El)
3eta-?ro3iolactone (3?L)
2-Acety laminof luorane ( 2-AAT)
l-Siae«ylaai.-.o4soo«r.2«n« C3A3)
JJ-Nitroscciaenhy lamina (CMS)
57573 •
29 CT? E:c=
:lusicr.ary Percentage
for Mixtures
_. J
* A
— . w
— . 0
1. C
*. 3
1 . C
2/ <** C^r^ ' •• ,-53^.',•»»•• ..*,»»0»  »'«*j»*,»-ioe  T™^ T3  e a 1 ^ -•
— wCrijri 3 —CS — --..^—•Cii  — .*t- — ^GSS  u^w-2  5&»» —^5 .

     Tr.s tnirteen standards control  exposures  tc  carcinogens by isolating the
£.rcs.s e:f possible srtpcsure with,  engineering  controls  and work practice re-
quirements.  Far example, closed systems.  aech.ar.ical  seal;;,  remote controls,
local £xnaust ventilation, laboratory  recces,  anc  transfer point operations are
usec to achieve an isolated system.  In  addition,  open vessel operations are
barbed  ^39 72 2739).  some cf the  standards  also  require personal protective
elctair.g and equipment to be used.   No permissible exposure  liaits were pre-
s^risad for the ^.h^r~ser: carc:_ncgens.  CSH.A  preferred ro prescribe engi::eering
centre Is and verk practice requirements  because the Agencv believed the;»e
n&t^ccs ''aost effectively isolated eerpleyees  fren potential  ccnt,ar:ir.ati:;n!!
'35 ~H :;."39).  CSKA considered the ecenccie  and technological fsasibili':y of
the standard's prior to their adoption.

     72e next section will examine the health  effects which  CSKA cited ,is the
rationale for designating and regulating each  carcinogen. Any special .regu-
lator"* erevisicas arclicable to  a  ^articular  chenical substance also will be
                               7ne  designation  cf »-Aninodiphenyl was based
on accumulated experimental and  epide=iclogic  evidence demonstrating that
-.-AZ? w=s the "acst hazardous  aromatic  anine  regarding carcinogenic potential"
(29 F?v ;:~56).  >*-ADP was shown to  induce  bladder cancer in huaians and t:
incuce malignant tumors in rabbits  and  nice.

     --N'itrobiphenyl .  In the  hazard  review documents, KIOSK demonstratsd the
structural similarity cf 4-Nitrobiphenyl  and  i-Aminodiphenyl ,   It documented
experimental evicence for the  in vivo formation of i-Aminodiphenyl froz
--.Nitrowiphenyl .  S'ICSH's review included epidemic logic investigations vaich
shoved the potential of 4-Aniziodiphenyl to  induce bladder cancer in huaans .
CSKA designated --Nitrobipher.yl  as  a  carcinogen en the basis of this evidence,
?r.e :- -:.he possibility that cases  of  hum as urinary bladder cancer, attributed
to only --Azitodiphenyl, aight have been  induced by exposure to <*-N"itrobi-
rhenyl ^29 TS. 3757) .

     A l::ha *Nat thy laaine ( 1 -NA'i .  Alpha-N'apthylanine is readily metabolized to
various cerivatives, several of  which have  a  demonstrated carcinogenic
potential in experimental animals.  In  particular, one metabolite of 1-S'A,
N-I-iydrcxy- l-naphthylasine, possesses  great  carcinogenic potential.
Ip icerrc logic studies have failed to eliminate an active role for 1-MA as a
human bladder carcinogen,  "or these  reasons,  OSHA designated 1-N'A as a
carcinogen and established health  stancards  for it.

     Beta-Napthylamine (2-N'A) .   In designating beta-napthylaarine , OSKA citad
studies wnich aenonstrated that  2-MA  induced  cancer of the urinary bladder in
dogs, rnesus monkeys, and hamsters.  In addition, studies showed that tumors
were incuced in other organs of  rats  and  mice exposed to 2-MA.  CSKA also
consicered epidemic-agio investigations of worker populations exposed to 2-NA
vhicn "clearly demonstrated that this substance was carcinogenic in hunans"


     QSKA excluded, operations involving the destructive distillation  of
carbonaceous materials from the 1-NA and 2-NA regulations because thess
chemicals will be controlled in separate regulations as components of  coke
oven emissions (29 CFR 1910.1009(a)(3)).

     Methyl Chloronethvl Ether.  Designation of this chemical was based  on
experimental animal investigations involving chemically purified methyl
chloromethyl ether which demonstratad that this substance possessed a
carcinogenic potential.  Additionally, epidemiclogic investigations which
strongly implicated aethyl chlcromethyl ether as a human carcinogen were citad
by OSKA.

     Unlike nest of the other carcinogen standards, this standard cid  not
include wash requirements for closed systems or transfer operation uses  of  the
chemical.  OSHA's rationale for this exclusion was that aethyl chlcrcnethyl
ether was a volatile material which would not be present long enough  for
routine washing or showering to offer any significant protection for  employees
working in areas where volatile materials were present.

     3.3'-Dichlorsber.zidine CDC31.  Controlled animal studies involving  rats,
mice, and hamsters showed DC3 to be carcinogenic in animals.  This evidence
served as the basis for QSHA's cetarsination that CC3 was potentially
carcinogenic in humans.  Extrapolation of animal studies to ."umans was the
sole designation criterion.  The NICSH hazard review document gave evidence
that DC3 was detected in the urine of workers receiving a minimum of
exposure.  However, the metabolism of DC3 was unknown, so CSHA did not rely on
this evidence in designating DC3 as a carcinogen or in setting the standard.
investigations with experimental animals  (sice and rats) '.
that 3 CHE was a "very hazardous carcinogenic substance." (39 F?,  2757)   These
investigations included skin application  and subcutaneous  injection  of  3CMZ  ir
experimental animals which resulted in malignant  lesions at the  site cf
application or injection and in malignant tumors  cf the  lungs.   In addition,
studies showed that 1 ppm or 0.1 ppm cf 3CME in air induced lung cancar in
mice and rats.  CSHA concluded from these studies that employee  exposure  to
3CMZ was extremely hazardous and, hence,  designated 3CME for regulation.

     Benzidine.   GSKA designated benzidine as a human ca.rcir.ogen because
experimental animal investigations involving rats, dcgs, hamsters, and  sice
demonstrated the carcinogenicity of benzidine.  Additionally,  epideaiclogic
investigations of worker populations exposed is benzidir.e  "clearly
demonstrated that this substance and its  salts (e.g., benzicine  sulfate)  '-era
also carcinogenic in humans."  (39 •"?. 2756)  The  epidemic logic studies  sr.cwec
that the incidence of urinary bladder cancar in workers  exzosed  to oenziiir.e
greatly exceeded the incidence cf this disease in the general  peculation.

     Although benzidir.e salts were shewn  to be carcinogenic in humans .  t.-.sy
ars net covered by the regulations.  The  Chemical Abstracts Service  Registry
Number  (92373) used to define benzidir.e in the regulations cces  not  induce
benzidine salts.

                          :.".',".  ':".-,e  carciTiCeEniciry of 1?L vas  descnstratad
  • nics. rats  ar.c nassters   The casigr-sticr. of 3?1 was based  solely qn  :hese
  'iz-- 1 «c.al*.~  effects becav,r<» er .cezio-logic -vidsnce dssonstratirig BrL t: be
  r-  -osrr.  •  " = "   'oa-ar-s vs.:, -st  avail?.':, .e  (2r 7- ~"~~

"*ol"i^j;  Titi.   .IIT.&,  racciti  ciogs , hamsters  ar,.; fowl were  ;itad ~''~ CSrlA as
avi :anca tnat  2--AA"  vas carcinogenic.   These stuc.ias demonstrated that 2-AA?
vas 3eta:;s.»r.ec  .n ar.iaals to for~ a  ncre  car.incgenic metabolite, N-hydroxy-
2-Ai7.   Jtner  studies shoved, tha: a'iaar.s  also ne:,abol;^2e ^-aAF  to the s&ae

2',s is or r.UTercu?  reports aemccstrating DAB  t: ?? carcincgsnic  in rats, dogs,

oenonsiruting  tr f.  .larcinogani: it} of  DM.N  ir  t.-.e 'iver, kidney,  lungs and nasal
area cf  :he  -a.~  as instrumental  in desissat in;; DM5 as a huaan carcinogen.   In

deocnstrating  :he  carcinogenicLty of  DMN  for the souse, hamster,  guinea pig,
"""Cfc**   '**d  se^'a^s1  ^oecias o~ £ish.

     DMN vas the  last of the zhesicals  regulated by 25HA in  the group of
     Vir.yl  c::l:mde:'' vas designated for regulation on  the  basis of
experimental  a::,isal arid auaan epidemic logic studies demonstrating its

     "he  carcinogenioity cf vinyl  chloride for rats, nice,  and hamsters
•s::-cseG  :y  msa'.aticn vas cocuaented in several studies  and a dose-dependent
relationship  f::r inductior. of tumors in rats and mice was demonstrated.
Exposure  con::a:itration.s as low  as  50 ppm vinyl chloride  induced 2.ngiosarcoma
cf the  liver  1:1 rats and mice.
       ^-ir.;".  c'-.l::r:r.e means  "vinyl  cr.lcriae mcnomer"  (29  CFH
      ~.~ .',':.   "^,  ,   ' (chlcroTthane} ,  Chemical Abstracts  Service Registry Numbe:

' ~ ., •.-.•:.rv!  i-.^.-r.:ie hoao-:o 1 virer  ;-  coaclvni'jr before such  is  converted tc  a


     Epidemic logical studies documented a. significant number of confirmed
cases of angiosarcoma of the liver among employees exposed to VC.  Cons icering
the extreme rarity of angiosarcoma of the liver in the U.S. adult male
population, this "is compelling evidence that exposure of humans to vir.yl
chloride induces this tumor."ia  OSHA cited additional evidence of tumor
induction in a variety or other organs, including lung, kidney, brain,  skin,
as well as non-malignant alterations, such as fibrosis and connective tissue
deterioration in designating vinyl chloride for regulation.  After considering
these animal and human studies, OSHA concluded "that VG must be regarded as a
human carcinogen, and the probable cause agent of angiosarcoma of the liver,
and that exposure of employees to VC oust be controlled."  (39 F3 35391).


     As with asbestos, a standard for occupational exposure to vinyl chloride
was included in the initial promulgation of OSKA air contaminant standards
under Section 6(a) of the OSH Act.  (36 FU 10506, May 29, 1971).  The standard
was derived from a 1969 federal standard issued under the Waish-Healy Public
Contracts Act and established an exposure ceiling for VC of 5CC parts per

     Pursuant to section 6(c) of the OSK Act, an emergency temp -rary standard
for vinyl chloride was established reducing the exposure ceilir:^ to 50  ppc  (29
T5. 12342, April 5, 1974).  QSHA cited the following reasons fcr establishing a
more restrictive emergency standard:

          (1)  New studies showed that tumors were observed in animals  exposed
to VC at concentrations as low as 250 pom.  QSHA concluded on the basis cf
this experimental animal data that VC was carcinogenic in hunans at tr.e level
of 250 ppm.

          (2)  Experimental results in rats, hamsters, rabbits, and dcgs
indicated that exposure to VC at concentrations of 50 ppm failed to induce
tumors.  OSHA concluded from this evidence that occupational exposure of
employees to concentrations of 50 ppm or below throughout their working
lifetime would be without detrimental health effects.

          (3)  The 50 ppm standard was "the lowest level that could ba
complied with immediately" (39 FR 12342).

     OSHA promulgated a permanent standard for exposure to vinyl chloride on
October 4, 1975 (39 FR 35390).  This standard prohibited asployee exposure  to
vinyl chloride at concentrations greater than 1 ppo averaged over any 5-hour
period, prohibited employee exposure to VC at concentrations graatar tnan 5
ppm averaged over any period not exceeding 15 ainutas, and prohibitec employee
exposure to VC by diract contact with liquid vinyl chloride (29 CTR
1910.1017(c)).  The standard was based on the demonstrated evidence of  VC' s
carcincgenicity in three animal species and the substantial probability that
      •*.-reamoia to tr.e Stancarc for exposure to Vinyl

. „ r.ad :. sfe- tr.s causa,  agent  ir.  cases  or  . iver ar.giosarcoaa found in wor:<-
er.     In setting the  vinyl  cnlcnce  standard,  the overriding consicerc.tion
was  tr.«: prct&cticr; of  employees,  even tncse w-o nay have regular exposures to

considerations, 2SKA would have  limited employee exposure to "2 to "no c.etec-
cai-e lt:Vil'' Because safe exposure levels  for carcinogenic substances cc.uld
not oe scientifically determined (29 ??. 25390).

     Upon consideration of .feasibility,  CSKA determined that 1 ppm was the
lowest «.tanc.ard the VC  industry  could  achieve with new technology and work
practice^ > ~? .'A*. vwc*«>^ .  uVen a . oca staiicarc wou_d oe acmevao.e, acc.ording
to CSKA, only (29 73 25390, emphasis added)  "for most job classifications
rest ;f tie tune'1 .  Subsecuent experience has demonstrated this to be
                               Isorgar.ic  Arsenic

Basis frr "esijr.aticn

     Incrgaz.-; arsenic': was  desigr.ated  because 2SHA determined that
-xpcsurs. tc mcrsanic  arsenic pcsed a cancer ris:< to workers.  CSHA's
iftterm.r.aticn was based  on  epideciologic studies of arsenic-exposed workers
•.nich showei ar.  excess risk of lung cancer ascng exposed workers, and  ir.dica-
-ec that, excass  cancer risk increased consistently with increasing degrsie  and
exposure, to inorganic  arsenic.   In addition, the studies suggested that  copper
aceto-arsenite,  sodiua arsenite,  and porassiun arsenite might be causal  agents
for lyrsp-iatic cancer.''*  CSKA considered NVICSH's view that, "when all  rs-
ports o: occupational  exposure to inorganic arsenic are considered together,
N'ICSH believes it undeniable  that there  have been carcinogenic effects which
asust be attributed  to  inorganic arsenic."11'

     It should be noted  that  there were  no positive animal studies to  confirm.
the epicene logical findings  of excess respiratory cancer mortality aocr.g
workers exposed  to  inorganic  arsenic.  Animals are so sensitive to arser.ic
t;jai they dis before cancers  can arise.   Thus, OSHA relied solely on
apiaeziclogical  data to  designate inorganic arsenic.

     2SHA designated both  trivalent arsenic (arsenite) and pentavalent
arsenic (arsenate)  for regulation.  The  distinction between trivaient  and
      *:"'Inorganic  Arsenic'  means copper aceto-arsenite and all  inorganic
 iontiounc.s  containing arsenic except arsine, measured as arsenic  (As)."   (29
      1ISC-rper  aceto-arsenite,  sodium arsenite, and potassiua arsanite  are
  overed  in  the regulations under the definition of inorganic arsenic.

       '  I'----'-'S.:--~--  Safety and Health Reporter, Volume 7, Number  30,  Mcy


pentavalant arsenic is important because  t rival ear.  arsenic  is  sera  toxic to
humaas than pentavalaat arsenic.  Ipidemiological studies clearly indicated
that trivaieat arseaic was aa important factor ia the  observed excess
mortality from lung cancer whereas  the role of pentavalent  arsenic  in
respiratory cancar was not so clearly defined.   CSHA based  the decision to
designate pentavalent arsenic as a  carcinogen on:

          (1)  Recommendations  ;rom the National Cancer  Institute and  NICSH to
regulate peatavaleat arsenic;

          (2)  One epidemic logical  study  which showed  a  substantial excess
cancar mortality among workers  exposed principally  to  peatavaleat arseni-
cals;'s and,

          (3)  The chemical similarities  between pentavalent  and trivalent
arsenic, and the strong evidence that trivalent  arsenic  is  a  carcinogen.


     OSHA adopted a consensus standard for "arsenic and  its compounds" uncar
section 6(a) of the QSH Act on  May  29, 1971 (36  ?R  10466).  This standard
established threshold limit values  of 500 ug/mj  for arsenic,  IcG '-ig/33 for
lead arsenate, and 10CO ug/m5 for calcium arsenata.:7

     A permanent standard for inorganic arsenic  was promulgated en  May I, 1373
which limited employee exposure to  10 micrograms per cubic  aecar of air bases
on an 8-hour time-weighted-average  (43 FR 19624) .  This standard was  basec or.
the body of epidemic logical evidence discussed above which  indicated -hat
inorganic arsenic was a human carcinogen.

     CSHA chose the 10 ug/a' standard because it was the lowest feasible
level for exposure to inorganic arsenic in terras cf technological considera-
tions.  OSHA's policy for carcinogens was to assume that there was  no  safe
level of exposure.  As a result:, a  zero level cf exposure would be  ideal,
except that technological feasibility must also  be  considered  in regulating
substances under Section 6(b) of the CSH  Act.  According to CSHA, 13 ug, -:
represented the lowest level which  could  be achieved by  using  engineering anc
worix practice concro_s in most  cooper smellers ano,  ctner trcces3£5  in  wniin.
inorganic arsenic was used.  The 10 ug/ni3 level  would  "minimize, to zhe
maximum extant feasible, excess lung cancar deaths  resulting  frca exposure to
inorganic arsenic" (43 73. 19624) .

     CSKA aisc analyzed the econcaic impact cf the  standard or. all  affactad
industries including the copper smelting  industry,  t.ie Isac smelting industry,
zinc smeltars, anc glass manufacturers.   CSHA ccr.cluc.ed  cr.at  the 12 -g. ~:
standard would not oresant ''overlv-burcansome" costs of  cocoliar.cs  to
      1SM. CH, 5. Holder, K. Gordon,  "Raspiratery  Cancer and Cccupaticn:
Hrpcsure to Arsanicals" Archives  Znvironmantal  Health 23,  2.30-;  (137-.'.
      • Arsenic,  lead  arsaaats,  anc  calcium  arsenata  ara  coverac in tna
permanent  regulations  unser  the  definition  of  inorginic  arsenic.

     Lea-:"* was designated  for regulation  by  CSKA  because of S3ec.ic.al and
scientific evidence - indicating lead  adversely affected the health of workers
ir. t.-.e lead industry.  This evidence induced epidemic logical studies and
•.xpenrer.tal investigations.  The  adverse  Lee', en  effects associated" witn
•r.xpc ?._•:.£ -3 isiti :nd cited  by 2?KA as  r :.ticr.a..a  for lead's designation,
u l.;iic ciam. £?! ~c.  four oasic iumar.  system::   neurological,  renal,
reproductive arid hens synthesis  (wnich is  : aspens ible  for oxygen rranspor" in
living systass;.
     A national csnsensus standard  cf  rb.e  Aaerican National Standards
Inr'irute was adopted by CSEA  for lead pursuant  ~o Section 6(a) of the OSH Ac:
in 15 ~1.  T^e permissible exposure  licit was  200 ug/a'  as determined by an
S-hour tiae -weight ad -aver age.  When CSrlA originally adopted the consensus
stinaard, nc rcitr.onala was provided for the  level selected.

     C£K.i "srosulgated a oersanent lead 5tar,;c.a:rc  en Novesoer 1—, 19~3 (43 r~R
52;5-) .   Tae permissible exposure  licit  (?HL)  set  by this standard was 50
iicrcgra.-:;. c<:: leas, per cubic neter  of  air  ;50  -j-g/m3) averaged over an 5 -hour
lerioc.   In addition, the standard  contained  a formula to calculate persissi-
ule s.xpcsurs l;j=i,ts  for exposures  longer than  8 -hours; this formula lowered
tne PEL as time exposed increased.   An action  level  of 20 ug/a3 (tiae-
weigntsd-averags based on an 3-hour work-day)  was  also established.

     The decision to establish  the  PEL was  based en  considerations of health
effects  associated win exposure  to  lead, feasibility issues, and the corre-
         • airocme concentrations  of  lead  with blood lead levels that were
associated with acverse effects  and  symptoms  of lead exposure.''3

     In evaluating tae adverse health  effects associated with.exposure to
lead, CSliA cecidac that "early stages  of  the  disease process characterised by
central nervous system symptoms,  behavioral changes, peripheral nerve damage,
ar.emii, reduced kidney function,  and adverse  reproductive effects represent
material impairment of the worker and  should  be prevented in order to elimin-
ate further development of disabling disease  and death."  (43 7R 32S63).
Thus, CSHA developed the permissible exposure limit.to protect workers from
"tne earliest ..ndioacions of  the  onset cf disease," as well as from -"the most
     ''"'Lead' means metallic  lead,  ail  inorganic lead compounds, and
organic  lead soaps.  Excluded  from this  definition are all other organic lead
compounds"  C? CTR  :--9iO . 1025 (b)) .

     1'Preamble to  Occupational  Exposure to Lead Final Standard, 43 ~R
;2S£3, November 14,  1978.


 overt  symptoms  of  illness."   OSHA intended this standard to prevent occupa-
 tional disaase  resulting from both acute and prolonged or chronic exposure to
 lead.   The standard also was  promulgated "to guard against the onset,
 progression,  or severity of  chronic degenerative diseases of aging workers.
 Furthermore,  the PEL was based on providing a degree of protection to "the
 acre susceptible,  as well as  the more robust members of tne exposed group  (-2
 TS. 52S63).""

      In order to establish a permissible exposure limit, CSHA estimated the
 blood  lead levels  associated with adverse effects of lead exposure and
 correlated these blood lead  levels wih airborne concentrations of lead.  CSHA
 utilised a physiological modal to calculate the predicted blood lead
'distributions at various air lead levels.

      GSKA determined that to  protect enployees from ''material impairment of
 health or functional capacity .  .  .  for the period of their working lives" (as
 required by Section 6(b)(5)  of the GSK Act), the mean blood lead level cf  lead
 workers should  be  kept below 40  ug/lOOg.  The provisions of this lead standard
 were designed to achieve an  airborne lead-level which would limit bleed lead
 (?b3)  levels  to a  mean blood level of 40 ug/lOOg.  A PEL of :C ug;3 	,,^

 not maintain  the blood lead  levels of all occupationally expcsec workers
 below  40 ug/lOOg.   However,  this PEL would substantially reduce the numser cf
 exposed lead  workers who would have blood lead levels above j.0 ug, 1-Cg at  any
 one time.   It was  this improvement that CSHA cited as the rationale for the

      OSHA based the action level standard of 20 ug/m: on evidence which
 indicated that  blood lead levels of workers (men and women) who wished to plan
 pregnancies should be maintained at less than 20 ug/lGOg during this tericd
 "(43 F3 52963).

      In setting the PEL and  the action level, CSHA considered the feasibility
 of the lead standard which must be met by engineering controls, wonc
 practices, and  personal protective equipment.  In evaluating whether
 compliance was  feasible, CSKA identified affected industries and investigates
 potential compliance methods including the available technology in these
 industries.  Furthermore, CSrIA estimated the length of time necessary to
 implement the technology required and tooK. into account tne firm's neec to
 plan,  construct, and test their efforts.  CSHA also assured tnat the standard
 reflected compliance time periods which would enable firms in each industry to
 comply with the standard "without serious economic repercussions to tne
 industry as a whole'' (-2 F3. 52973;.

      CSHA identified primary and secondary saeltars, pigment manufacturers,
-brass/bronze  foundries and battery manufacturers as the industries witr. tne
 greatest potential difficulties in complying with engineering controls.  The
 50 ug/m: exposure  limit was  the lowest level for which tr.ere was evidence  cf
 feasibility for these industries.   CSHA stated that the :C ug/m3 PEL was the
 level  which represented the  "best intersection oetween maximisation ef .tealtr.
 benefits and feasibility" (43 F3 52S62).

     •reuzsns"" was cesignatsc or. trie oasis c:  s-ientinc  eviaence whicz
estarlisned that employee exposure to benzene  presented  a cancer hazard.
5sr.zer.s -as snowE to attack t.~e hesatopcistic  (oload-fcr-ing)  systems and the
bone narrow.  Adverse •hesatcpc.ie.tic effects cf benzene including leukesia were
ciicui.er.ted in a variety cf industries and occupations such as  the rubber,
snofe. rotogravure, painting, cnesicai rrocessir.*;,  and can sanuf acturir.g
ir.nustr :.es .  "ae types of studies cited by GSKA were single huaiar. case
rsccrts  crrss -ssctisaal huzar. studies, retrospective studies  of scro.idif,' and
scrtality  ascng a defined cohort of workers industrially  axposed to benzene,
anc experiaental deaonstrations of zarrow toxic:ty"in anisals  exposed to

     i N'ICSrI report cited by CSHA in the designation of  benzene for regula-
tion stated:

           N'ICS'li considers the accusulated eviaer.ce froa  clinical as
           «ell as epideciologic data tc be conclusive at  :his  tiae
           that benzene is leukeiogenic.  Because it causes progress-
                 £nc.s, tnat ror regulatory turposes,  oenzene can we
          considered carcinogenic  in man.1'

     After considering all the scientific/medical  evidence available, CSKA
concludes that benzene exposure was causally  related to  the induction of
leuKe-ii, various cytopenias  (decreased  levels  of  a  fomed element in the
circulating blood), aplastic  anexia (a non-functioning bone marrow),  and
CHTOCOSc~aI aberrations.   .o  mnir^ize tnese woricer nea*tu risr^s resulting rrort!
cnronic exposure to  low  levels of  benzene,  CSrLA designated benzene for
— —O "
          CSHA adopted the benzene  consensus  standard cf the Anerican National
Standards Institute in 1571 under the  authority of Section 6(a) of the 3SH
Act.  This standard prescribed  an 8-hour  time-weighted-average of 10 ppa with
a ceiling concentration, of 25 ?pm,  and allowed  excursions above the ceiling to
a aaxizua peak concentration of 50  ppm for  10 minutes in any 3-hour work
period.  This standard was set  to protect against adverse health effects of
benzene, including blood  changes and  aplastic anenia, but not including
laukazogenic effects.
     :c'"3enzene'  (C.H.)  (CAS Registry N'o.  C0071432)  means solid,
                     o  c
liquef.ed or gaseous benzene.   It  includes  mixtures of liquids containing
benzene and the vapors released by these  liquids" (29 C?R 1910.102S(b)).

     "N'ICSrL Criteria  Document  for Occupational Exposure to Benzene, 1976.


     N'ICSH submitted to CSHA a criteria document in August  1975 which
conduced chat benzene was a leukasiogen, and recommended that  "no worker  oe
exposed co benzene in excess of 1 ppm in air."  NIQSK acknowledged  t.-at no
"safa" level for benzene exposure could be established.

     In response co the criteria, CSKA issued an emergency  temporary scar.card
for occupacional exposure co benzene in May 197" (42 FR 12515), under  the
authority of Section 6(c) of the Act.  A limit of  1 ppm benzene in  air for  an
8-hour time-weigiiced-average was included.  This standard never officially
went into effect because of legal challenges filed both in  the Court of
Appeals for the District of Columbia (Industrial Union, AT1-CIC v.  3ir.gham,
Mo. 77-1295) and in the Court of Appeals for t.ie Fifth Circuit  'API v. CSI-lA,
No. 77-1515).

     A final permanent benzene standard was promulgated en  February 13, 1373
(43 F3 5513) and invalidated by the Supreme Court  in July 1980.1J   This
standard limited employee exposure to 1 ppm as an  3-hour tiae-veighted-average
concentration with a ceiling level of 3 ppm for any 15 minute  pence curing
the 3-hour day.  The standard also prescribed limits on eye  and skin contact
with benzene.  The focus of the benzene scancard was en minimizing  wcrsar risk
resulting from chronic exposure to low levels of benzene.

     CSHA selected the 1 ppm exposure level for the benzene  standard because
it was the lowest feasible level.  It was CSHA's view that  "cnca tne
carcincgenicity of a substance has been established qualitatively,  any
exposure must be considered to be attended by risk whan considering any given
population"  (43 F3 5932).  Thus, CSHA prescribed that the permissible  exposure
to benzene be reduced to the lowest feasible level.

     To determine the lowest feasible level, CSHA  evaluated  the technological
feasibility and the economic impact of the benzene standard  on affectad indus-
tries.  Compliance costs for petroleum refineries, coke plants, petrocnemical
facilities, bulk terminals, oil and gas industries, transportation  operations,
and rubber products manufacturers wers assessed by CSKA.  ~rctn this study of
compliance costs, CSHA determined that the 1 ppm standard was  economically
                             Coke Over. Zmissicr.s

Basis for Designation

     CSHA designated coke oven emissions1J  for  regulation primarily  secausa
of evidence indicating tnat CCK.S oven emissions playec  a causal  role
     ".ne supreme '.curt -ustices  fai.ec.  to  agree on  a  rationale  for
invalidating the standard.  Industrial "nion. ATL-CIC v. American  Petroleum
-nst itut a , 43 .3In» 5C22, 19SO .

     *3"'Coka  oven emissions mean the benzane-solucla  iracrirr  ;f  totcl
particulata matter cresent during  the destructive distillation or  carrcni^i-

:,r. -.:*  --culler,  or  lung iar.ce:1 2nd ?ir..tc-^r_r.a:"-  tract  cancer Lz exposed
C!cpulati.:rs .  T;.i« eviaence induced epice-iclog_oal  surveys .  ar.iaal studies,
anc _.-.sz.-2.1 analyses  of coke ever, emissions.

     ^wii'i s~"z~ scissions are £ c~~plex "ixture cf ^articulates, vapors, 2nd
gases,  ii' vr_icr. cultiple carcinogens anc cocarcincgens  h.avs  beer. ic.eniif iec.
T.-.s cr.«r.:;ils fcusd  is coke over., saissicns *r.ich sre  generally  recognized as
-s.rcizcg'L^s are:
          "    3esio(a)  pvrene,
          »    Beazo(b)  az'hraceriS
          *    Chrysene,
          •   • Aa-iracene,
          •    Phenan'hrene,
          •    Acridiaa,  and
          *    Pyrens.

Agents k::;ow~  to  enh.auca  "he effec~ of chemicil c.arcia.ogar.s  aspecially an the
: s-spirit-ry tract  were  also identified in coke oven  ezissicns.   No one
su.bst3r.ee u:  cose  over.  sKissions was selected for  regulation "because neither
tr.e 3£rr.«r in whic-  such substances interact no.: the specific causative agent
had beer, identified  vith regard to the aultipla  -7?es  of  c:Er.cer resulting  from
exposure to coke oven emissions."  (i-1 ?K 467^5;.

     In Designating  coke oven ecissions for regulation, CSHA also cited
cossrvat:,ons  of  anunals  and of husan populations which deacnstratec that skin
fuacrs could  be  induced  by  constituents of coke  oven emissions.  "This evidence
vas ralaied to increased skin cancer mortality in  coke oven workers.  Fir.aliy,
t'SIiA ccn:i iderec  epideniological studies which showed an elevated risk of
ncr.--r.£_i:-a^.t respiratory diseases sucn as bronchitis  and esphyseaa in cake
     Standards  limiting worker exposure to coke  oven  emissions first were
adopted  37 CSJia  under Section 6(a) of the CSH Act  as  established Federal
standards.  The  CSHA standard set a coal tar pitch volatile (defined as the
bencene  scluable fraction and listing certain carcinogenic components
      1 *A.,.tha-nc.t;~hylaaine and beta-napthylamine were  regulated by OSKA  in
tze grcur  of  thirteen carcinogens, but the regulations  excluded coke oven
errissicr.! .  Both  substances are covered under the  permanent coke oven
esLiss ICT.S.  s tancard .


anthracene, benzo(a)pyrene, phenanthrene, acridme, chryser.e,  and pyrar.e)

threshold limit value of 2QOug/m  .  No rationale was provided  by GSKA  for
selecting -his level.

     The permanent coke over, emission standard was promulgated en October  22,
1376 (il FR 467i2) .   This standard established a permissible exposure  limit
(PEL) of 130 micrograms per cubic meter of air detarmined as an 3-hour
average.  The criteria used to determine this standard included the health
effects data cited above and the technological and economic feasibility  of the

     In evaluating the technological and economic feasibility, C5KA focus ec  on
the steel industry because it was the major industry affected  by the coke  evar.
standard.  GSHA cited, as indicative of the minimal economic impact and  rha
technological feasibility of the standard, the fact that none  of the stael
industry spokespersons testified that the proposed standard for coke oven
emissions would "imperil the existence" of the U.S. coke incus try (-1 T3.
     As with the other carcinogens regulated by GSHA, no safe  Laval cf
exposure to ccka oven emissions was known.  Thus, tne PEL was  sat  as
restrictive as technological and economic feasibility considerations  allowed.
                                   :tton Just
     CSHA's designation of cotton dust-' for regulation was based on  epi-
demic logical and clinical evidence that cotton dust produced  adverse  health
effects asong cotton workers.  These adverse healtn effects included  acute
affacts, such as depression of pulmonary function  incicators, chest-tightness,
shortness cf breath and coughing, and chronic obstructive  oulscnar"" disease.
Syssinosis is a respiratory disease specifically attributable to the  action  of
cotton dust on respiratory passages.  Syssinosis causes healtn  effects  ranging
from acute to chronic and from reversible to disasling, which have  ^aen "con-
clusively shown" to be causally related to exposure to cotter, dust.   (-2 r?.
273^2).  Thus, GS?IA designated cotton dust for regulation  to  racuce the risx;
of cotton dust-inducad respiratory ciseasas in workers.
     i5Thesa compounds ara covered by the present stancarc..
          ^ __ i  _; __
         <^o«ton cus t                      *              ig    —
processing of cotton, which aay contain a mixture of many suostancas  inducing
grounc-up plant matter, fiber, bacteria, fungi, soil, pesticicas,  non-cotter.
plant aattar anc other contasinanta which nay have  accuaulatac with the  cotton
during the growing, harvesting and subsequent processing or  storage per ices
Any oust present curing the handling anc processing of  cotter, througn  tr.e
weaving or knitting of fabrics, and dust present  in otr.er cperatir.g cr  manu-
facturing procasses using new or wasta cotton fibers cr cotton fioer  :"-pr:o,-
ucts from taxtile mills ara considered cotton cust'1   19 C77. I?".!1  !!-].:''

~z~ rag—it ion Because tr.e  active  agent  or  azer.ts  ir. cotter, dust have net beer.
ia^-t_i.ec,:,  Zy orcac.ly defining cotter,  cust,  CSKA assured tr.at the causative
iSer.ti cc.~ta:_".ec. in tne cotter.  e.ust  mixture would  be covered by the regula-
     C-SHa. adopted a standard of  1000  ug/a:  for "ccttor. dust (raw)" under
Section 6 a; cf the OSH Act in  1571.   This  standard originally was ar.
a?t,a:lis:.ec Fecs.ral standard uncer  the *alsr.-Healy Public Contracts Act,

     CSHA adcpt&c a permanent cotter,  dust  standard an June 22, 1S7S (-2 FH
2~253^,  The permissible  exposure  limit in  the standard varies according  t:
tr.e t'.-De ci industrv as displayed  in  Exhibit  1-c.
     ..ie cexti.e mcustry stancarc  was  oasec priaarily on an epiaenic.cgica.
stucy vhicn evaluated the prevalence  of byssinosis in the United States
textile i::custry.  Approxiaateiy  2,000  workers  employed in S cotton and
cotton-synthetic, blend £ills,  control synthetic nills and wool mills were
in*, p.stigated.  The study desonstrated a strong  linear association between the
prsv.ildr.cis ~: byssinosis and  the  concentration  cf lint-free respirable dust.

     The N'ICSH Cotton Dust  Criteria Dccunent prepared in September 19Ti
re-ccsnencad to CSHA that "no  environmental  liait cf cotton dust will prevent
3.1, acverse effects on workers  health".  Recognizing the absence of any known
''safe level of exposure" to cotton  dust,  CSrlA set the permissible exposure
li^it >'?!!) of 100 ug/ts" for  the  textile industry on the basis of feasi-
bility consideraitions.  CSKA  concluded  that "on the basis cf all the currently

available evidence, 200 ug/m   of  respirabie cotton dust appears to represent
the lowest possible level." (43 77.  27253).   The epideziological data iz-ica-

tac that ,1 200 ug/'m"  PEL would result in a  prevalence of byssinosis of 12.7
percent, -hich CSHA considered "to  provide  substantial protection for eo-
p.cyees e:

     GSHA established an exposure limit of 500 ug/m   for non-textile  indus-
tries without the aid of quantitative dose-raspon.se data as was  available  for
establishing the PEL in the textile industry.  OSHA instead relied en  evidence
which suggested that cotton dust affected workers in  a similar manner  wherever
cotton dust was generated.  Citing the dose-response  data  for the textile
industry, OSHA determined that cotton dust levels in  non-textile industries

also posed health risks, and sat the 500 ug/a  PEL as the  lowest feasible
                                 EXHIBIT  1-6

                          Cotton Dust Standard a/

                                       Permissible Exposure  Lave
      Type of Industry                  (over 3-hour work  shift'i

Textile                                        200 ug/nT

Textile (Slashing and Weaving)                 750 ug/m

Non-textile                                    500 ug/m
     In the development cf these three co-ton dust  standards, CSHA  evaluated
the economic and technological  feasibility of each  standard.  Evidence  demon-
strated that in textile and non-textile  industries, modification  and  acapta-
tion of existing dust control systems would permit  compliance with  t.te  stan-
dards in the vast majority of workplaces.  In the assessment cf economic
feasibility, CSKA conducted a thorough study of the economic impacts  en
affected industries.  CSHA concluded  from this study  that  the cctton  cust
standards were economically feasible  and that the regulated industries  vcu.lt
oe acie to survive tne cost or  compliance.
     a,'  .ne 5tanc,ard apo.ias to  .int-free  rastirac^a  cotter,  oust  whit.t  -3
defined  in the regulations as  ''particles cf  cotton  dust  of approximately  li

                                       in c:.-ten g_ns was based or.  2SKA's

 cute respiratory dysfunction.  The  previous section cf this paper  concerning
 rie general cotton dust standard  describes  tnese adverse health effects  i::
 etail.   .-Icverse health effects associated  with cotter, dust in cotter,  gin;; can
 -e a:rp-»ct3C to se the same  as  adverse  haalth effects associated with cust
 .-,-.'.ri.-^c at all ctr.e.- stages  cf  cotton prc-ca.ss ing.  Evidence indicates  that

 urtnerr:c::e, cotton cust generated  during girding contains the saae subst^mcas
 S rotten dust generated at  all other  stages of cotton prces>ssir.g.

     l.;K.~. tronulgated a. separate  standard specifically for cotton  dust in
 otter. s~-s Because cf the  unique characteristics cf cotton gizaing which
 icsssiiatad cifferent treatment  froa  other segaer.ts of the cotton  industry.
" :r r..xar:p-e, tna pattern of  exposure to cotton dust in gins is different  ::ros
,-,? pattern ir. tr.e rest cf  the cotton  incus",r-   'workers in cotton  gins  are
;xT,-csec ;o cotton dust only  for brief,   r. -a.™;, »"tor.t periocs.  rather than  Icr.g,
 -iar- round -ixposurs.  No evidence exist;; of -hror.ic respiratory disease  acsong
gir. vri'.srs exposed to current levels  c: cus • in. U.S.  gins.  Tnus,  3SKA  d«ci-
:iu "c '.s":;i:. -sr, z stinkard  specif ical lv ior the Aiming ses^nent  of the  cc;tton
     The final standard  for  cotton dust in cotton gins did not  establish per-
rissiole exposure  lisits  as  were  established for other segments cf  the  cotton
industry.:;!  Instead,  CSKA adopted vork practice controls and respiratory
conrr: Is :.r.cluci_ig nedical surveillince and enployee education.   OSHA  con-
tlucec tnst worv. practice and  respiratory controls would provide  "an  accep-
tarle =r:r;;in cf safety for ginning employees'1 (i3 FR 27422).  This  standard
-..as vacated and remanded  to  CSHA  by the Fifth Circuit Court cf  Appeals.

     OSHA considered  the  economic and technological feasibility of  this  stan-
dard prior to its  promulgation.   A study of :he standard's econonic impact: en
affected industries was  conducted and the costs of coapliance estimated.  The
study indicated that  application  of the 200 ng/m  permissible exposure linit
(the ?IL for the rest of  the cotton industry) to the cotton ginning industry
     2'"'Cotton  dust'  means  dust present in the air during  the  handling o:r
processing cf  cotton which nay contain a mixture of many substances  including
grcund-vp plar.t  natter,  fiber, bacteria, fungi, soil, pesticides,  non-cotton
,; l:-.-:r.  a?tter   rid  otter  contaminants which say have accumulated with the
setter, during  the  growing, harvesting, and subsequent processing or  storage
par iocs'1  ,[29 CFR 1310 . 10»6 (b)) .

       -3 " 2"-lS  June  23,  19TS.

                                    .-3 -

                                   (•*3 FR  27il3) .   However,  -he study concluded
that ~he work practice controls and  respiratory  controls  required by the
cotton dust standard for cotton gins would be  economically  and technologically
                     l,2-Dibrcmo-3-chloroT3regane  (

Basis for Designation

     CSIiA established a standard  fcr occupational  exposure  to  DSC?-'  en the
basis of scientific evidence that employee  exposure  to  DSC? presentad a hazart
of cancar and sterility.  Results cf animal  studies  mcieacad  DEC?  to be a
potant carcinogen in two sexes of two mammalian species at  two cose levels.
Additionally, DBC? caused positive results  in microbial assays designed.to
detect chemicals capable of tnutagenes is.

     The conclusion that DBC? posed a sterility hazard  was  based en ar.imal
studies demonstrating that oral dosages of  DBC? induced degeneration of tasti-
cular tissue, reduced sperm count and initiated abnormal sperm cell develop-
ment.  Furthermore, these tasticular effects were  confirmed in humans.   Reear.:
studies have indicated that a large number  of male  enployees e.xpcsac re lew
levels of DBC? in the manufacture and formulation  of pestiiiies  suffer from
sterility and infertility.  Cn the basis cf  this  evider.ca,  C3HA  concludec t.-.a'
DSC? had "proven carcinogenic and stenlant  potential"  '|-2  ?R  11516',,, ar.c
thus, should be regulated in the workplace.


     Sased on a determination that employee  exposure to DBC? preser.tac =
"grave danger" of sterility as well as  cancer, CSKA  published  an er.ergency
temporary standard on September 5, 1S77 (i3  F"R -3536} regulating DEC? exposure
in the workplace.  Issued 'under the authority of  Section 6(c1  cf the CSH Act,
this emergency "standard established an  8-hour time weighted average ?I1 of 13
parts DBC? per billion parts cf air, with a  permissible ceiling  of  £0 ppb as
averaged over any 15 minute period in the workplace

     The final permanent DSC? standard  was  promulgated  on March  '.',  1973 (-3
73 1151i).  The standard limits employee exposure  to DSC? to 1 part DSC? per
billion parts of air (1 ppfa) in an 3-h.cur tiase-weightec-average  concentra-
tion.  The standard also prohibits eye  and  skin contact with D3C?.   The rasas
for the final standard were human and animal data  demonstrating  t.-.at  DBC?
causes sterility and animal data  indicating  that  exposure ~z DBC? presents a
cancar hazard to wcrxers.  "CS>Li maintains  that a  substance whicr. causes
cancar in animals aust be considered as tcsing a  carcir.ozsr.ic  ris.-c  to vene-
ers" (-3 ?S 1152C).
     1""DEC?' means  l,2-dibremo-3-chlorepropane,  Chemical  Abstracts  Service

     ™"."~  1 ctb  ccT.cer.traticn level rscrssentec tn.e lovert  extsosurs  level
dc.-._eva; .e -S :_•:.£  present tec^c.ogy.   Sir.ce  users were no  cose -response iata
. -^r ..unia^.1 exposures  »c *Jt***~ ;  wwr^i — .s 2 un* S-C  .zat any *eve* or  exposure tc ./^*«.
r-csec, a  ,:ar cine genie risk tc exposed individuals.  In" addiiior.v tsere'.wa.s
•iviuencg  tna~ ISC?  mcuced sterility =nc  infertility ir. workers  exposed to *0
exist -*r...cr.  crevice's  5sir*icisi.* mrcr^ation  zc accurate. v "Dredic"  a  sa..s  cr
' nc effect'  level,  assuiair.g one exists ,  viih respec': ^o tae sterilar." effaces
~f Z2C?,"   S^  F?, 11120).  Taking inio  canside-~at;ior. The "nature cf the
r.anarc^ :::f 3'3C?  exposure and "he mani-ir."  cc ue: ermine an exposure level -'r.=.~
v"'   ° '  ' ** i "^- -* * e  the  *"*3k o^ cane*1* IT and  ste*"**"*"7f   Q^"i S"* ^'"^e  ^"''  » — ^- "*'2^o a —
the lowest  level tecnnoiogic.all" feasible.

     ~.z assess  the  feasibility cf the  D3C?  standard, CSHA considered ,"-; the
levels  j:, -2C?  exposure attainable using existing controls;  (2) trie
sophistication  of existing control aethodologies ; (3) the economic  inosnrives
ror cent ^.nLiec .»ww.  oroi^uoticn, mc.uo.in^ tne costs ct coct'.ianwej  tne
me . as 1 1 cnt3;*  c~  oecianc, tne ^iziite^.  sca*e c* trocuctio^n^ a^^ic  tne  pcss-io*s
cn^-nsrSi  ;^. s£rs:et structure with respect tc  DBC?; anc ( — '! the relative
so' r.isti:.£"ior.  cf :,ae companies producing Z'3C? v;,th rsspec: to  csr.tr :1
ta-'hnc Ic :;v.   Ir;  li^ht cf these consicaraticns , OcKA determined  the  1 ppb ?ZL
~" w^ ,- e "..nrx-1 ^ oz »c £._ . v a_~i r eccncctic.il -'*'  ieas~»i.,6  '**3 r"R 11.S21).

     Tr.e  D3'J? standard does net apply  to exposures which result solely froa
tne aptli.cat ;or  ar.d use of D3C? as s. pesticide.  QSHA beliaves  the  control of
23C? as .-, pesticide by I?A under the Federal Insecticide, 'Fungicide, and
Racer. t_nde  ict  irovices "an effective  aroroach to protecting all  workers
against the  zarards of exposure to D3C?"" (-3 FR 11522). :o
;-3.sis  rrr  jes i^T.atior.

epidemic logical  data indicating  that  exposure to AN presented  a cancer hazard
tc wcr.iers.   Experimental studies  showed excess incidences  cf  tumor forsula-
tirr. ...~.  ;_v^expc;je.d ar.iziais and epideciological data indicated  excess cancer
dcong  vorkers  expcs.ec to AN.  Moreover,  AN was sncwn to be  capable of mducin=
=utatior.£  i
      3SZ?A  issued a Notice of  Intent  to Cancel for 03C?  on  October 29, 1=79
 ;—. F?.  £5125).   A Notice of Intent  to Cancel gives'the public an opportunity  '
tc request  a hearing to review the  cancellation of the registration of a
pesticide.   A hearing for DBCP was  scheduled to begin in September 1980, but
was delayed until further notice.   EPA requested the delay  to negotiate an
igreener:: with registrants and environmental groups.  At the  time of the
car.' el la;. 10:; ncticfe, £?A also  suspended the use of DSC?  until the cancellation
issue  is  res^lvec..

      '•'"  Aery lonitrile'  or 'AN'  means aery lcr.it rile acnoaier,  chemical fors-


     GSEA cited, as evidence of AN's health risks, the results of  the National
Cancer Institute's carcinogenicity testing program which  "recognized
acrylonitrile as carcinogenic to experimental animals."   Additionally, N'lOSIi
concluded that the results from experimental animal studies  "strongly suggest
that AN is carcinogenic in man."  OSHA also cited results of studies conducted
by the International Agency for Cancer Research  (IASC) of the World Health
Organization and the Food and Drug Administration in the  determination t.-.at AN
is a. human carcinogen.

     Liquid AN11 also was specified for regulation to assure that  all
intermediate products of the AN polymerisation process were  covered by the


     Occupational exposure to AN was limited by  OSHA to an 3-hour  time-weighted
average of 20 ppm in 1971, under Section 5(a) of the QSH  Act.  This 20 ppm
standard was not based on carcincgenicity of AN, but was  based on  its high
acute toxicity and its similarity to hydrogen cyanide.

     On January 17, 1973, CSHA issued an emergency temporary acrylcnitrile
standard (^3 TR 2536).  This emergency standard  was based on CSKA's
determination that "exposure to AN posed a grave danger to humans  because of
AN's carcinogenic potential."  The standard established a PEL of  2. ppm as an
3-hcur time-weighted-average with a ceiling limit of 1C ppm  (15-amuta

     7ne final AN standard was promulgated on October 3,  1973 (-3  73. -573:).
It adopted the emergency standard and set the PEL at 2 ppm (3-ncur average),
with a ceiling level of 10 ppn (15-minute average).  In addition,  the final
standard established an action level of 1 ppa as an 3-hcur time-weighted-
average.  As discussed above, the basis for this standard was CSKA's datar-
minatior. that AN posed carcinogenic risks to workers.  CSHA  believec  t.-.at
standards for substances which had been found to pcse cancer risks to workers
must assure "maximum benefit (i.e., prevention of serious illness  cr deatnj
constrained only by the limits of feasibility'' (-3 7R -5790).  Accordingly,
the PEL represented the lowest level which OSHA  believed  to  be generally
achievable through the use of engineering controls, wcri<  practices and respi-
rators.  The standard was based upon analysis of the affsetae industries  taken
as a whole because a facility-by-facility approach would  have been extremely
difficult to implement.

     In accordance with Section 6(b) (5) of the CSH Act, CSrIA ccnsiisrac the
economic and technological feasibility of tr.a AN standard.   The  extermination
that the PEL was technologically faasibile was oasad on nearly universal
      3:"Liquid AN' means AN mcncmer  in  liquid  form,  and  liquid  or  semi-
liquid polymer intermediates,  including  slurries,  suspensions,  emulsions,  ar.d
solutions, produced during the polymerination  of AN"  (23  C7K  1313 , 13-5 ";)] .

 .z~2&~^r~.  :y  the  affected companies that e,;.:stir.2; techr.clogv  and rr.odif.Lcaticns
 f e:;i$t _r.g technology  would be ca~ar:le of recucing  exposures  in most cosra-
 icr.s re oelow  the  PEL.   To assess t.ie economic feasibility of the AN stan-
 ar::, trie  cost:- rf  compliance were estimated and the  imoac.cs  on crinca.1
 s2,"-,;ria_,: , r.ar:-'e;: structure, pro-cuctivity,  asplcyment,  energy,  and prices were
 -x/::ir. -c, ftr  ::.*  A.I  nidus .ry.   Tie results  ;;" t.ia s.ucy  mcicirad r.'r.d'; c.ie AiN'
 "^r:.c.ari «a.i  e:.cnczic£lly feasible for the affected  indus-ries.
     7^e des;.gr.arioa  ef  berylliu=::  for regulation under  tie  CSK icr was
ba.se; on epices:ioiogic.a.l and clinical evidence of acute and chronic b.eal:h
affacts ;j; workers  exposed to berylliua, and on experiaental  animal data
showing that berylliuz cocpounds  produced cancer in  laboratory annals.   Acute
*ea-zh effscs cf berylliua cited  by CSHA included effects  on  the eye and skin
area and restiratory  effects.   Chronic health effects  included pneuaonitis,
sy-itensi. cisease,  and puizcnary cysfunction.
     C;rl:'. initially  asopted the Aaerican National Standards  Institute's
    _ „ i «ir.* stcn.c.arw m  accordance witn section c(a^ or  tne  Qoii Act.   *^*i
standard prescribed  an  s-hour tiae-weighted-average cf  2.0  vig/a  with a
c-eiling concentration of 5.0 ug/a" .   In addition, the standard allowed a
peak concentration above the acceptable ceiling  concentration for an 3-hour
shift of 25 •-g/=w,  for  a  =axiru= duration of 2C sinutes.   Tnis  standard vas
Ociseo on exo^.r z^nent a _  anunai c>ata anc on analogy witn  incustriai air ^inits
for sucn toxic hea\-y metals  as aercury. cacxiun , and thalliuc;  the ceiling was
ia,sac or. act-,2.1  cos»/ respcns0 data taken in -pi an:.

     OSH.A proposed  a berylliun standard on October  17,  1973  (iO ~R i381i)
recucing tne permissible  employee exposure for an 8-hour  tine-weighted-average
concentration :o 1.0 ug/a .   The proposal also set  a 5  ug/m   ceiling limit
for e^csures to airncrne concentrations of beryllium  (15-2inute averagi.r.g
tiae]1 ,  e»iz:inated the  peak concentration level of 25 ug/m ,  and proposed a
dermal exposure,  limit.

     In developing  this proposed standard, CSIiA considered reconnendatio.r.s
contained in the NICSH  document, "Occupational Exposure to Beryllium (Criteria
for a Hecssmenc.ee Standard)"1* and the Atomic Energy Commission's Control
     3:"'Beryllium'  means elemental beryllium and  compounds  and alloys o:
bt —-lliuTi  ;as  elemental beryllium) that may be  released  into the place o:
ecrolo'.Tsent  as  ^articulate matter or that snav be  oresent  in the olace of
      3"N-:CSH,  «aihingtcn,  D.C., C?KS, KiMH^) ,  19:2,  (HSM 72-10258).

Recuiraser.ts for Beryllium, as well as almost everything  alsa  puolished  en  the

     CSIiA dacidad Co lever the PEL to 1.0 ug/3~ because cf  evidence
indicating that beryllium exposures in aost cases ware being controlled  ''to

well below the currant standard" of 2.0 ug/rn  (40 ?R 43813, October  17,

1375).  The 1.0 ug/m  proposed standard represented a compromise  "between
the best medical and scientific evidence on the one hand  and practical
consideration cf technological and economic feasibility on  the other."  (4Q  7R
43313)  GSHA included a dermal and eye exposure limit for bulk forms  of
beryllium1* in the proposed standard because of human and animal  studies
demonstrating that the "soluble salts of berylium" upon contact,  produced
adverse affects to the skin and eye arsa.

     To date, no final beryllium standard has been promulgated by CSKA.  The
agency is determining whether the standard is needed or net.34


     CSKA promulgated a set of regulations on January 11, 1980 (45 ~R 5002)
for the identification, classification, and regulation of toxic suostancas  for
which there is reported to be evidence of carcinogenic potential  in  humans.
These regulations are referred to as "The CSKA Cancer Policy"  and wars  issuec
as Part 1390 of Title 19 of the Code of Federal Regulations.

     The announced purpose of the regulations are:
          (1)  to provide an orderly, comprehensive,  consistent,  and  scien-
tifically feasible system for regulatory  actions  to  reduce  or  prevent wcrke:
exposures to potential carcinogens;
           (2)  to persit CSKA to  regulate potential  carcinogens  in  a  timely
                o present the  factors CSKA will  consider  ir.  setting  priorities
for the regulation of potential carcinogens;  and

           (4)  "-o carry out the  intent of the  [CSK]  Act with  respect  to
identification, classification, and  regulation  of  potential  occupational
carcinogens"  (29 73  1990. 102).
      35   3ulk  foms ' aeans beryllium which  is  not  airborne  but  wmch  pcsas
3. demal hazarc to amployees upon  contact with,  or  penetration cf  t.ie  skin.
— ucn  rcrms mej.uo.e so — uo«e oery .*ium, cocrtoouncs  or  soiic  ~or^s  v i • a . ,  zr^'s *
tals, chips, shavings,  etc.) of soluble or  insolusla  ber*/llium wcich  could
penetrata the skin."  (29 C73  IS 10.1026(b)).

      "Scurca.  2SHA Staff.

categories expending, on  ''t.ie  nature  and extent cf the availasla,,scier.tif :.c
evidence    The classification  syster. clear .y specifies the criteria CSKA vill
rel-- cr. vher. -lasignating  substances  as  circ.L:^c~er.ic anc, -hen ssta::lisr.ir.|.
s :.£r.carc.s f;r taem under  trie  CSH  Act.

     Specifical ly, a substance  is  identified, classified, and regulated as  s.
C.afjgcry I Potential Carcinogen if the  substance meets the definition cf a
potential occupational carcinogen37  in:   _fi_j.huaans,  cr (ii) in a single
^a.Ts=,l_ar, species in a long-term  bioassay wr.are the results are in concordance
vit^. seta--. :~~'i- scientifically  evaluated evidence of a potential carcinogenic
hazard cr ...li:.} in a single mammalian species ir. an adequately .conducted
lcr.g-te—. bicassav,  in appropriate circunstancss . "  (29 C73 1990 .112 ,'a)) .
Conccrc.ar.ca is dencnstratad by  any cf the following:  "positive results iron
^ndepends.nt tasting  in the saae cr ether species,  positive results in
short-tera tests,51  or induction  of  tuners at injection or implantation
sitas."  (25 CTR  199C.112(a)) .

     Category II Potential Carcinogens  include substances which:   (1) "meet
-ne critarii. se-  fortn in .SS0.112(a;  ; f or a Category I Potential Carcinogen;,
sut t:.e fevicencs  is  founc to  be only 'suggestive'" or (2) "neet the  crita.ria
set forth in 199C.112(a)  in a single aasaaliaii species vitbout evidence cf
conocrcar-ca" ;29  :?R 199C . 112(b)) .

     CSI-L?. distinguished  between Category I 

Priority Setting Provisions

     The regulatory provisions are intended to establish a "flexible process
for screening evidence on substances that may be potential occupational car-
cinogens and for setting priorities among such substances for full scientific
evaluation and regular'on as potential occupational carcinogens."  >;-3 FA

     The regulations require CSHA to establish two priority lists for regu-
lating potential occupational carcinogens.  Each list should include "approxi-
mately ten candidates for rulenaking."  One list should be for Category I
Potential Carcinogens while the other should include candidates for Category
II Potential Carcinogens.  The factors, specified by CSHA, to be consicarec
when setting priorities  include:

               (1)  "The estimated number of workers exposed;

               (1)  The  estimated levels of human exposure;

               (2)  The  levels of exposure to the substance which
                    have been reported to cause an increased
                    incidence of neoplasms in exposed humans,
                    animals, or both;

               \,**)  The  extent to wnicn regu.accry action ccu.i^
                    reduce not only risks of contracting cancer but
                    also other occupational and environmental health

               v, j j  'rthetner tne mciecu^ar structure or tne sucstance
                    is similar to the molecular structure cf another
                    substance which meets the definition of a poten-
                    tial occupational carcinogen;

               (5)  Whether there are substitutes that pose a lower
                    risk of cancer or other serious human health
                    problems, or available evicence otherwise sug-
                    gests that the social and economic costs of
                    regulation would be small; and

               (7)  CSHA will also consider its responsibilities for
                    dealing with other health and safety hazards and
                    will consider the actions being tasan or planned
                    by other governmental agancias in dealing with
                    the  same or similar heaitn and safer" hazards
Rulesakinz Procedures

     The CSI-IA Cancer Polity prescribes specific rulemaxing procecures  for
occupational carcinogens.  The raouired contents of orooosac stancarcs  and
emergency tssrccrary standards for both categories of potential laroir.oser.s
specified.  This is to acnieve consistency among future  rulemakmgs  :cr

     _-er.s r;._ rrrtvisicns  for tne use cf =.r_i.-:;.; ,-nd husar.  data  also are included
_r. ~.~.e Ii"-L-. Cancer  Policy.   These zrovisicns review zest  cf the  scientific
_s.:ues cci-.cs.ri.ing  carcinogens  anc establish general riles  concerning the use
c: scientific  information cr. carcincgsnesis   In addition, Part  1990.,1-46 lists
tns issues * n .:c;: .say  be  considers— • r rctantial carcinogen rulenskings .   The
purtc-s-i cf tzes-; sections is  tc irprcve bet::: the efficiency  arid specificity
-2 :nc.i ritual  r.lamaklngs,  ensure uniformity cf treatment  and avoid continual
re., tigst icr. cf issues  alreacy clearly resolved" (i5 F3  2212).

     Tinally,  tLe  CSHA  Car.car  rclicy presents tvo racdel  standards for DSHA tc
rcllcv ir. carcinogen  r^leaaking proceecir.§s.   These exanple standards include
=. per^ans-.-.; stancard  foraat anc. an emergency tesporary standard  fcraat.   CSHA
ixplainec. that  'tne inclusion  cf nodel standards is expected  to  isrorsve OSKA' s
ao'_litT to restsnd  aporooriatel™ to scientific evidence  concern—ng potential
ccc.utatiC'.za_ carcinogens  anG tnereoy neip tiransto_wj tne  Cancer r^o*icy into
tan^iz^^ «uut_oyee  protection  \.**-^ -"• 2***>Ss •

31'T.y.r" rL-.rA?-_"rT.NTI7ICATICS'  .--NT) LABELING

     2Si-La nas  proposed  and subsequently withdrawn generic  hazard
•.o-inT. -,f ic at ion .me  labeling standards for iheicica.s categorized  as physical
:.£,car^s , =cute, subacute  health hazards, and chronic health hazards.33  The
f; .lcvir.£ Tsv.av ;f the  trctcsed standard is for information  only.

     Tner a were four  aajor provisions tc the; proposed rule.   First,
3 a. |, ,  DrJ'iuZH!  ,   «ARN_NG! ,  or  CALT..CN! ) , a statement or nazaras,
pr&cautior.sry  statements, instructions in case of fire,  spill, or leak,
ar.t_cc*.e  .nforaation,  and instructions for container handling and storage.
7r...rd  manufacturers  and industrial users were required  to provide eaployees
'•""-"-•- ~."~j--a-  safatv  data saeets to supplement the information on hazard
warning Iaoels.  Tne  data sheets were to include detailed  information about
tr,i properties <3nd handling of hazardous substances and  mixtures, and were to
be updated according  to  procedures specified in the proposed  standard.
Fourth, to enable  workers to aake their own hazard determinations and to
evaluate their' employer's determinations, aianufacturers  and iaroorters were
required re maintain  hazard evaluation files containing  references, studies,
reports, and other  documents usec in hazard evaluation.
      :3CS"-LA  Prc-ocsed Rules Cn Hazard Identification,  »6  TR ^412, January Is,
       W:.tncrawn  February 12, 1981, i6 FR  12020.


     The proposed hazard identification and labeling rule applied to
substances and mixtures which fall into two general hazard categories.
Category A included physical hazards and Category B included  acute/subacute
and chronic health hazards as displayed in Exhibit 1-7,  Substances and
mixtures, with the exceptions of nuclear material, food, and  tobacco, which
aet the definition for one or mare classes of hazards were to be covered by
the proposed rale.*'

     To determine if substances and mixtures net the criteria of Category  A c:
3, manufacturers and iaporters were required to evaluate scientific reports
and other data according to the procedures presented in Appendicies A and  3 o:
the proposed rule.  Mixtures were to be evaluated for hazards on the basis of
their constituent substances unless hazard data concerning a  mixture as a
whole were available.*1
     "*"Substances and mixtures used  for scientific  experimentation,  chemical
research, or produc- development were covered only  by  the hazard  evaluation
rile requirements.

     14 "'According to CSHA's proposed rule, a mixture poses  tne hazards  of  its
constituent suostances  ir.

           (1)  "The mixture contains  a constituent substance  in  an
     amount of at least 0.1*  (by weight) which  is determined  to  be  a
     carcinogen.  .  .  ."

           (2)  "Any of  the constituent substances cf  the mixture in
     an amount of at  least 1.0% (by weight) meet the  definition  for
     one or more Category A or 3atagory 3 hazarcs.  .  ."


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                        DEPARTMENT OF TRANSPORTATION
    Both the'Department of Transportation's Materials Transportation Bureau
(MT3) and the U.S. Coast Guard (USCG) promulgate regulations concerning the
transport and handling of hazardous chemicals as authorized by several
statutes.  These statutes are reviewed in the following pages:


         •   Explosives and Other Dangerous Articles Act
         •   Hazardous Materials Transportation Act  (HMTA)


         •   Dangerous Cargo Act (DCA)
         •   Bulk Flammable and Combustible Liquids  Act (3FCLA)
         •   Port and Waterways Safety Act  'PV'SA)

    Although the KMTA authorizes DOT/MT3 to regulate "any safety aspect" of
the transportation of hazardous materials "by any mode," DOT retains
independent regulatory authority under several other laws including the
Federal Aviation Act, Federal Railway Safety Act, Motor Carrier Act, Natural
Gas Pipeline Safety Act, and the Hazardous Liquid Pipeline Safety Act.  These
laws are not reviewed here.

    The statutory and regulatory reviews that follow have net been reviewed by
the Department of Transportation or the U.S. Coast Guard and do not
necessarily represent the official position of those agencies.  Moreover,  this
'material does not necessarily represent EPA's official understanding of DCT
 (MT3/USCG) authority.  Tne contractors 1CF  Incorporated and Lawrence V.
Sierlein, P.C. are solely responsible for all interpretations and analyses.


    T~is statute was repealed very recently.  Although  it  is  no  longer on the
.-ccks and 20 longer serves to support specific regulatory  action,  its  place in
history provides auch guidance in interpreting activities  of  hazardous;
materials transportation regulators to date.  This  is the  statute  undnr which
the first hazardous materials transportation regulations  (49  CTX 1CO-1.S9) were
issued by the Interstate Commerce Ccsmission.  Although acre  recent  statutes
now support those regulations, those regulations reaain auch  as  they were
under the Explosives and Other Dangerous Articles  (IDEA) Act.   In  addition,
references in other statutes and regulations to "explosives and  other
dangerous articles'* may be traced to this statute.

    Only six aateriais are aentioned in the definition  section  (Section 321)
of thes statute.   Four of them are to delineate between  similar-sounding
ir.ass;   detonating fuzes, fuzes, fuses, and fusees.

    The two other definitions were added in 1960 in  an  effort to clarify
authority over two types of hazards that the statute previously  covered
inaccurately as  poisons:  '"Radioactive aateriais' aeans any  materials! or
combination of aatarials that spontaneously enit ionizing  radiation;"  and,
'"Itiolcgic agents' means tr.e causative agent of such diseases  as  aay  from
tine r:o tise be listed in the regulations governing  etiologic agents
prescribed by ~ha Interstate Gonaaerca Ccoaiission under  .'.3  USC 33~."

    Specific acts with regard to explosives were deamed criainal in  Sfiction
52T.  The materials were "dangerous explosives, such as and including,
dynamite, blasting caps, detonating fuzes, black powder, gunpowder,  or other
like explosive."  Joined with these explosives were  radioactive  aater:.als and
etiologic agents.  Paragraph  (b) of this statutory  section listed  certain
other explosives (liquid nitrogiycarin, fulainate  in bulk  in  dry condition)
"or other siailariy dangerous explosives," or radioactive  ziatanais  o::
etis logic agents.  The regulating agency was given  the  power  "from tine to  "
tiae ':o detaraine and prescribe what explosives are  'other similarly dangerous
explosives.'"  Other than by the examples of nitroglycerin and fulainate, no
guidance was gi%ren to the agency to aake this determination.

    section 32^- provided authority to ''formulate regulations  for the  safe
transportation within the "Jnitad States of explosives and  other  dange.rous
articles, including radioactive aatarials, atiologic agents,  flananabl'i

liquids, flammable solids, oxidizing materials, corrosive liquids, compressed
gases, and poisonous substances."  These terms, generally called
classifications, wera not defined by the definition section of the statute
(Section 331),  but served to provide examples to the agency of the types of
hazard to be regulated in transportation.

    The regulations ware to be "in accord with the best-known practicable
means for securing safety in transit."  Generally speaking, therefore, the
authority was limited to governing materials that posed a threat of acute
injury or infection while being transported.  Concern for property was
addressed only indirectly, in Section 322, where the regulating agency was
given the power to allow small quantity shipments on passenger vehicles that
were determined "to involve no appreciable danger to persons or property,"
Other references to property are in describing non-passenger carriers as
carriers of property, as that class of commercial entity is regulated by the
Interstate Commerce Commission,

    This statute, frequently referenced as the HMTA, supplanted the Explosives
and Other Dangerous Articles Act as the legislative basis upon which the
Department of Transportation (EOT) issues and administers the Hazardous
Materials Transportation Regulations, 49 CTR 100-139.

    This regulatory authority under the Explosives and Other Dangerous
Articles Act had been limited to carriers engaged in interstate or foreign
commerce and their shipper customers.  The regulating agency's authority  and
jurisdiction were broadened to permit DOT to govern transportation that is
both interstate commerce or that "affects" interstata commerce.  This
generally is recognized as the broadest grant of authority Congress can sake
under the Commerce Clause of the Constitution.

    The HMTA contains a general definition to guide the Secretary of
Transportation in designating materials as hazardous.  "Hazardous natarial" is
defined in Section 1302(2) as "a substance or material in a quantity and  fcra
which may pose an unreasonable risk to health and safety or property ween
transported in commerce."  The transportation intended includes "any movement
of property by any aode, and loading, unloading, or storage incidental" to the
transportation.  The tsrm "property" in this context is not defined.

    Section 1303 gives DOT broad "discretion" to designate natanals for
regulation..  Upon a Secretarial "finding .  . .  that the transportation of a
particular quantity and fora of aatarial in commerca nay pose an unreasonabla
risk to health and safety or property, he shall designate such quantity and
        USC § 1301 at seq.

fcrr cf materia. cr group cr c_ass cr  such mdteria.s  as  a hazardous
catar«al ."  Vhils taere  is referer.cs to  "findings"  and to "designation," the
statute is silar: or. the mecrxanisz. for these  functions,  but it has been
asi-unec tr.at tze rule making power granted to DCT uaaer  Section 130- of the
I-2TT.1 is at least one appropriate nechanisa taat  may be used.   The materials,
dea .gnatec. say include, but are net limited to,  "explosives,  radioactive
sat.-in als,  etiolcgi" agents, flann;able liquids or solids, combustible liquids
c"z series <  pcisc'~ .-, cxicizmg or corrosive £aateri,a.»s,  an~c cccitressed ^ase£ .
fnc.se vsms, howaver, are set statutorilv defined.

    T^e section-~"-section analysis of this statute in Senate Ccmaercs
Co=ittae Report No. 93-1192, 93d Cong., 2d Sess.,  September  30,  13 7-, says o:
Section 13C2:   "Tnis section provides  that the Secretary is to designate &
3ata:ial cr a. quantity cf caterial as  a  hazardous aatarial after  finding ::hat
tae trans:;ortation of that material cr a quantity or  fora cf  material in
scmnerce aay pose an unreasonable risk to health and  safety or property.  The
Secretary is not linited in the kinds  of materials  which are  within this
purview; the section names certain kinds of possible  hazardous saterials by
way o: illustration rather than limitation."   The series of "possible
bazirdous  materials" given in the list cf examples  clearly is drawn fron the
si.nlar series ^c Section S3i of the earlier  explosives  and Other Dangerous
irt -lies ..ct  discussed  above.
    r?,e purpose of the statute  is  to  give  DOT the authority  to protect the
.•^ati^n adequately against the risks to  life  and property which are inherent in
tne transportation of hazarccus naterials  in ccaaerce."  (Section 1301.)
S*guli.tic;is authorized in Section  1305  "may  govern any safety aspect of the
transportation of hazardous materials which  the Secretary deens necessary cr
appropriate, including, but not linited to,  the packing, repacking, handling,
l^oeling; narking, placarding,  and routing (other than with respect to
pipelines;, of hazardous materials,  and  the manufacture, fabrication, marking,
icamtenance, reconditioning, repairing,  or testing cf a package cr container
which is  represented, marked, certified, or  sold by such perscn (sic) for use
in the transportation of certain hazarcous materials."

                     U.S. COAST GUARD — STATUTORY REVIEW

    The Explosives and Other Dangerous Articles Act provided that regulations
issued thereunder would be binding upon carriers engaged in interstate or
foreign commerce by land, and the shippers who used their services, as vail as
upon shippers of hazardous materials via any carrier engaged in intarstata or
foreign commerce by water.  The regulations, therefore, did not apply by -hair
own tarss to water carriers.

    This coverage was provided by the Dangerous Cargo Act (DCA) .  lika the
ECDA Act, the DCA provides specific statutory prohibitions with regard to
specifically identified materials.  For example, under Section 170(2), no cne
nay ship or carry "fulminates or other detonating compounds in bulk in dry
condition, or explosive compositions that ignite spontaneously or undergo
narked decomposition when subjected for forty-eight consecutive hours to a
temperature of one hundred and sixty-seven dagraes Fahrenheit, cr compositions
containing an ammonium salt and a chlorate, or ather like explosive. '  It is
unlawful under Section 170(4) to carry on any passenger vessel ''any high
explosives such as, and including, liquid nitroglycerin, dynanita,
trinitrotoluene, picrates, detonating fuses, fireworks that can be exploded an
masse, or other explosives susceptible to detonation by a blasting cap cr
detonating fuze . "

    Regulations issued by the Coast Guard must be followed in transporting or
using aboard vessel "any other explosives or other dangerous articles or
substances, including flammable or combustible liquids, flammable solids,
oxidizing materials, corrosive or combustible liquids, compressed gasas,
poisonous articles or substances, hazardous articles, and ships' stores and
supplies of a dangerous nature."  (Section 170(5).)

    Section 170(7) compels the Coast Guard, however, to accept and adept the
"definitions, descriptions, descriptive names (and) classifications" tsar were
adopted under the Explosives and Other Dangerous Articles Act for
applicability to shippers by water.

    This statute vests the Coast Guard witn broad authority ever tanx vessels,
which carry hazardous materials in bulk (not oac.-;agsd or containerize", .  3y
    3-6 USC ! 170.

    *4c USC § 19la.

rsgulaticj-.. nor-b-Ik  quantities  ar? .governs; under the HJTTA,  2r.fi  bulk
C'^^n* — ~ " ^^  £.~ "i ',1T.C.? JT  3 3C~ " C~  ~ *" * c.  i" T.I1C H""*"" "°'"lc^rs " S nQ "•—••• * a * -' -^  * — *"*"& ZJvx**^ i
-'..£'; co™<;ls ;'-;.s  division.   Section  391i is hc-sec -per. a Congressional
statement cf policy that  declares ""he carriage or vessels of certain cargoes
in sulk or  in residue creates  substantial hazards to life, property,  rhe
r.svi2£.-lfc wafers of ;he United  Srazes  Cizcludir.§ -he quality  thereof) and the
resources c=r.ta:jicc therein  and  to the adjcir.ir,.§ land, iritludiag  but  not
limited t;s  fish, shellfish,  and  wildlife, ss£rir,e snd coastal  ecosystems, and
recreational and scenic values  ^Section 3?lsv'ri) / • "

    V"ni,le granting substantial  regulatory pcwer to the Coast  Guard,  the
discretion  to designate materials is  limited by tae Statute.  The BFC1A, in
paragraph  '1)(C),  defines  "hazardous  aaterials" as "any liquid  material  or
substance wnich is -- (i)  flaznable or combustible.;  or (ii) designated a
hasarccus substance under  Section 311 Co) of the Federal Water Pollution
-ontrcl1 Act, as amended  (33  USC  § 1221(b));. or (iii) designated a hazardous
satsrisl -under Section  10^- of  the Hazardous Materials Transportation  Act O9
"ZZ i 12C.V."

    Tr.e "narine envirosaent"  is  defined in paragraph C2)(D) as  including all
navigable waters,  all waters  and fishery resources over which jurisdiction is
asserted by the "J  £., the  seabed and  subsoil of the Outer Continental Shelf as
wsl. as tiie Vc.tg.r5 and  resources adjacent thereto, and the recreational,
ecor.^zic, and scenic  values  of  such waters and resources.  Congress  found
s-xistins ."tancarcs nust be sere  stringent and coanrrehensive for the  mitigation
ur i^e  ^iazarvs 'o  .ire, property, anc tne uiarine »nvircnmen»>

    an  in":arast:jag feature of  the 3FCLA is its treatment of the economic costs
associate::  with protective standards.   Regulations are to be  based  on 3es:
.-.va_laale Technology  (3AT) unless the result is undue economic  impacts which
are iot outweighec by the  benefits of the standards.  The approach  used  by the
£?i, to  establish National  Emission Standards for Hazardous Air  Pollutants
bears some  similarities  to this  mandate:  EPA's policy is to  establish a level
cf protection based on  Best  Available Technology supplemented by  a
cansicersfion o: the  reasonableness of tae residual risk, if  any.5


    This statute is both  a safety and an environmental protaction act.  Tie
Congressional declaration of policy in Section 1221 declares, among o.ther
things, "that ng.givation  and vessel safety and protection of  the  marine
     *See  complete  discussion in Regulatory Seview, Clean Air  Act,
Section  1..2

     *33 U2C  §  1221 et  sea.

environment are matters of major national importance.''  Congress further r.ctas
Thar increased supervision of vessel and per: operations is necessary "to
rsduce the possibility of vessel or cargo loss, or damage to lira, property,
or the marine environment," and "to insure that the handling of dangerous
articles and substances on the structures in, on, or immediately adjacent to
the navigable waters of the United States is conducted in accordance with
established standards and requirements."

    The Coast Guard may issue broad vessel operating requirements under
Section 1223.  In carrying our these responsibilities, the Secretary of the
Department within which the Coast Guard is located must "take, into account all
relevant factors concerning navigation and vessel safety and protection of the
marine environment, including but not limited to (1) the scope and degree of
the risk or hazard involved; (2) .  . .  the presence of any unusual cargoes;
.  .  .  (5) environmental factors; and (7) economic impact and affects. ..."

    With regard to waterfront safety, the Secretary say take such action as is
necessary "to protect the navigable waters and the resources therein frca harm
resulting from vessel or structure damage, destruction, or loss.  Such action
nay include, but need not be limited to (A) establishing procedures, measures,
and standards for the handling, loading, unloading, storage, stowage, and
Movement on the structure (including the emergency removal, control, 2nd
disposition) of explosives or other dangerous articles and substances,
including oil or hazardous materials as those terms ara defined in Section
»^17a of the Revised Statutes, as amended (46 USC § 39la) . .  .  ."  Oil is
defined in Section 39la of "oil of any kind or in any form, including, but not
limited to, petroleum, fuel oil, sludge, oil refuse, and oil nixed with wastes
other than dredged spoil."  Hazardous nateial is defined to include all
hazardous substances designated under Section 311 of the Clean Watar Act and
all hazardous materials designated under the Hazardous Materials
Transportation Act.

                       -F 7?J>.NS?C?.TATT-N'  --
    The followz^ig reviews discuss regulations  prseulgated under the
 eviewed previously.  The first regulatory  review covers hazardous
 egulations promulgated under HHTA, the  second review c.overs those
 oz-uiisterec by the Coast ju,.£rd.  Only reigulatisns propicsed or praa
 hrough January "., 19S1 are included.
    'The regulatory reviews of  2QT and USC3 regulation;; were prepa:
Lawrence W.3ierlein, P.O., subcontractor to ICF Incorporated.


    The majority of this regulatory review will focus on the hazardous mate-
rials transportation regulations administered now by the Department of Trans-
portation (DOT).   The need for this focus is the multitude of other regulatory
schemes that adopt or cross reference DOT hazard designations.  Throughout
transportation, but also in non-transportation regulatory programs, the  influ-
ence of the DCT regulations is fait.  This impact is not necessarily  consid-
ered by DCT or reviewed by other program managers when basic DCT changes  are
made.  Therefore, it is essential to have a thorough knowledge of the core  of
these regulations, in order to assess the merit of their utility in other con-

    The federal Hazardous Materials Regulations ara published by DCT  in  Parts
100-139 of Title 49 C7?..  The regulations are issued under the authority  of
the Hazardous Materials Transportation Act (HMTA), 43 "SC 1 13C1, 1SC4.   Tr.ay
may be applied to all carriers and shippers of hazardous materials, ar.d  all
makers of packaging sold for hazardous materials, moving in commerce
"affecting" interstate or foreign commerce.

    Section 1303 of the HMTA, describing DCT's authority to designate hazard-
ous materials, authorizes controls over any materials including "but  not  limi-
ted to" explosives, radioactive materials, etiologic agents, flammable liquids
or solids, combustible liquids or solids, poisons, oxidizing or corrosive
materials, and compressed gases.  (See tne Statutory Review for further
details).  The HMTA regulations to date have only been expanded significantly
beyond those enumerated hazards to accommodate EPA-designad hazardous
substances and hazardous wastes in the CRM-I class, described zcre fully  below.

    Under Section 13C2, in order to designate a. material as hazardous, the
Secretary of Transportation mist find it is in a quantity and form that  say
pose an unreasonable risk to health and safaty or property in transoorta-
tion.  There is no separate procedural mechanism to identify new materials  re
be brought under transportation regulatory controls.  To data, to the axtant
designation has occurred under the HMTA, it has takar. placa in the informal
and loosely structured dialogue of agency ruleaaking.  The regulations cur-
rently appearing in 49 C7R were issued as HMTA regulations with an effective
date of January 3, 1977, but the rules cid not come into being at that zim«.
They had seen in place for cany cacaoes, administered first by the Intarstata
Commerce Commission and then by DCT uncar authority contained in the  Ixplo-
sives and Other Dangerous Articles Act, 13 USC § 321-525 (since repealed;

    Neither the facts necessary for cesignaticn of new hazardous materials
under the HMTA nor the auantitative criteria uocn which a desiznation decision

would be based are specified 37 DOT, and perhaps  are  not  ever, know
c£"£,.cp£C nc sys—&za»ic n~~noc rcr ns& assessment  or evaluation.
consistent ccr.sicersti;T. ~f tne quantity cr  form  of materials in :
assessment.  There is no .
 impact,  the agency is  likely to be persuaded to ameliorate its proposal.  In
 no  clear sense,  however,  is  there any agency program or obligation to choose
 the less expensive of  two proposals that nay work squally well.

     COT  has the  authority to expand and revise the classifications and ha-s
 done so  in recent  years with the creation of the Blasting agent and Other
 Regulated Materials (ORM-A,  3,  C, D,  and E)  classes.  Wnile many GRM-A, 3, C,
 and D materials  had been  subject to some controls in transportation, the rule
 changes  creating the OKI  classes made applicability of the federal regulations

     Currently regulated DOT  classifications  and their 4-9 CFR definition
 sections are as  follows:

     Explosives,  Class  A,  3 and  C (173.50, 173.53, 173.33, and 173.ICO)
     Blasting agents (173.ilia)
     Flammable and  Combustible liquids (173.115)
     Flammable solids (173.150)
     Cxidizers (173.151)
     Organic peroxides  (173.15la)
     Corrosive materials  (liquid and solid) (173.2*0)
     Compressed gases (flammable and non-flammable) (173.3CO)
     Poisons, Class A and  3 (173.326 and 173.343)
     Irritating materials  (173.381)
     itiologic agents (173.386)
     Radioactive  aatarials (173.339)
     ORM-A, 3, C, D and Z  (173.500)

     In virtually every classification,  there is a aechanism whereoy hazardous
 materials that do  not  exactly "fit" the class may be relegated to -hat class
 nonetheless.  In addition, for  some classes  there is a aethod to remove tne
 material from the  class despite the fact that it does fit technically.  The
.legality of this awkward  process has never been challenged.  As the various
 classifications  are described below,  those paragraphs by which 3CT adopts the
 fit of the classification will  be highlighted.  In general thesa are little
 used sechanistas  with almost  no  procedural precedent, and they are unlikely to
 be  used  extensively in the future.  The abova classifications will each be
 described in turn.


     An explosive (whether Class A, 3, or C)  is defined as "any chemical com-
 pound, aixrurs,  or device, che  primary or common purpose of which is to func-
 tion by  explosion, i.e.,  with substantially instantaneous release of gas and
 ~eat, unless such  compound,  aixture,  or device is otherwise specifically
 classified" elsewhere  in  the 3GT regulations.

    .ne exp.osives c.assif icatior, is an cecity.  It is the  one DCT  class
cation (along with the related Blasting agent class) ~o~  left to  tne  di:
t:.or. cf the shipper of the procuct.   The shipper of an article that say
explosive first must submit that material to the 3ursau of  Explosives, ,
n:.cal arm of the Association of American Railroads.  This is a private,
governmental laboratory that for over 73 years has performed this funct
A,ft,ir testing, the Bureau cf Explosives will classify the material  and,
is assigned to the explosives class, will prescribe the A,  B or C desiz
ticn.  Under 49 CFR 172.26, the classification of commercial explosives
reserved to the Bureau of Explosives.  Explosives develcpec. for the Ene
Research and Development Administration or the Army may be  classified b
two agencies.)  While there is no shipper discretion to classify  explos
the shipper does have the obligation to know that there ar
Alcohol, Tobacco and Firearms (3A..-) regulations which new  incorporate  iafini-
ticns of blasting agents."  (43 FR 57393, December  11, 1973)  With  creation of
the new class chere wera simultaneous creations of  new shipping  names,  libels
and placarding requirements for blasting agents.

    A blasting agent is defined in 49 CT3. 173.11^a  as, "a material  designed
for blasting which has been tasted in accordance wih  (prescribed test)  and
found to be so insensitive that there is very little  probability of accidental
initiation to explosion or of transition from deflagration  to detonation.   The
definition includes tests that must be passed,  including a  blasting cap sensi-
tivity test, a differential "hernia! analysis tast,  a  thermal stability  tast,
an electrostatic sensitivity test, an impact sensitivity test, ar.d  a fira
test.  After performance of the tests the aianufacrurer in addition  must
receive DOT approval for his assignment of the  blasting agent classification,
unless specific laaaratories or agencies have written that  there are no
significant differences in hazard characteristics relative  to a  blasting agent
already approved by DCT.  The examination and tentative- classification  of  new
blasting agents must be done by the Bureau of Explosives, the Department of
Energy or the Department of Defense.

    While this is a new classification tiec to  the  explosives group as  cppcsac.
to the oxidizer gcup, it is not an explosive A, 3 or  C, but is an incepencent
classifcation.  The label on the blasting agants looks similar in color to an
explosives label, but does not carry the "exploding bomb" uN symbol.  DCT  said
in its final amendment that no symbol is displayed  "due to  the fact that
blasting agents present a much lower level of hazard  in terms of their
detonation potential than Class A and 3 explosives  for which an  ''exploding
bomb'1 is displayed on the label."

    As noted above, the Bureau of Explosives has the  primary responsibility
for assigning articles to the explosives class.  The  work of the Bureau of
Explosives has evolved since the 19th century and has frequently beer, criti-
cized for a lack of procedural consistency or quantification.  Much of  the
classification decision is based upon the experience  of the person  running the
test and his subjective reaction to the performance of materials in the test,
relative to the performance of other materials  in other tests.   The Department
of Transportation has long had a low priority project to revise  the explosives
classification to more quantitatively and consistently define maiarials in
that class, but the conclusion of this r-lamaking may be years away,

    Another factor that must be noted about this class is that tie  classifi-
cation is inextricably lir.kad to the ''primary or cooaacn purpose'' cf tr.e mate-
rial to function by explosion, as statad in .xe definition.  Iitarall;*,  ".113
means that a material which may explode, but coes not have  the purpose  -f
explccing, does not fit the DCT definition.  While  th_s factor nas  seen raises.
in criticism of the definition, it has never been judicially resolved.

    It should be noted that the ''reactive" category in tne  E?A ragulations
under Section 2C01 of the Rasourca Conservation and Recover? Act -.'ill induce

aany explosives that are discarded,  bur  that  category c,oes act overlap  the
explosives classification exactly.

    49 CFP. 173.115 declares that  a  DOT- regulated f 1 ammab 1 e 1 iqu id is one
havirg a closed-cup flash point below  100°F.  (37 . 8aC. ) ,  with certain speci
axe-, scions.  The arceptioas basically  are  those which fall within the
flaisiabis  liquid class by the closed-cup  flash point tester, but by logic
i:ct f t it.  These includes gases and  materials having minor amounts of
CE-.-.— ,a,i.n : Jig radiants that give extramely  low or high flash point readings  i
the closed tester, without regard to their true fire hazard.
       _      ih la liquid , defined  in  49  CFR 173.113,  is one posing  less  or
£ iansmabili":y hazard, having a. closed-cup flash point  at or above IOC0!.  (2
C.} and below 20Q°F. (93.3°C.).  The  combustible liquid class also  has  cer
exceptions based upon  illogical  results  of test methods.  For example,  an
aqueous solution containing 24%  or less  alcohol by volume is "considered :
h-we'1 a flash po-jit ro  less than 1GG°F  ,  i.e.,  is  a combustible liquid,  i:
ratrainder y£ the solution does not meat  the definition of another mazardcL
xatisr \al .   Such liquids  are assigned  to  the combustible liquid class desp;
'iv.j f.ict triey otherwise  seat  :he fj^ammar^la liquid definition, because cf
mi? Ie,ii.ciri5f; 'test results  caused by  the ilosed-up test  method when appliec :
             j.c"  liquids  also  ara  regulated by DOT and ar« described  ir.  +1-
             the  class  definition  section,  but they do net fora a separa.t
 lassification.   For DOT  purposes  a pyroprtonc liquid is my that ignites
               :jo.  dry or Tioist  air  at or below 1303?.  (54..5°C.).
    '."be f Lammas le and  combustible  liquid classes were revised by DOT  over
period of several years  in  the  1970's,  in rulemaking Docket No. KM- 102
"wunvTy 7'.:.rposas of  the  HM-102  redefinition of the flammable the comfau;>ti
liquid classes were    (1) to  raise the  definition limit for flammable  :iq-
fioaj 30°?. to  100 °F.,  and  (2) to  change the basic methodology from  the  cp
the cnosec-c-j.p tester.   The first  change was not, justified on the basi:>  o
transportation safety  but,  rather ,  on  administrative consistency with is im
definitions under federal Occupational  Safety and Health 1.QSHA) Regulatio
C?l.5 ™f;< 1:U0.136).   A  similar purpose  was cited abova ,  for creation of  th
3 .astini; age.it rlass.  The  primary rationale for changing to the closed-c
"ester vas & parallel  drawn between a  closed transportation vehicle and -
closed -cur taster,  in  the trapping of  fumes from a liquid that night  not
5 reading of f lannaability  in  an open tester.  The only other major  federa
de£i£iticr of  f laramability  at that time was administered by the Food  and
AdEir-istr -t lor. but ws,s prescribed  by statute at 80°F (see statutory revie
Federal Hazardous Substances  Actl.

    The 100-200°?. combustible liquid flash polar definition was taken from
CSEA regulations as they reflected National Fire Protection Association  (N7?A)
standards.  This is a classification of materials generally not subjected to
substantive DOT regulations.'  No HMTA regulation applies to unit quantities
smaller than 100 gallons (unless these materials are hazardous wastes or
hazardous substances), and even in bulk land transportation the requirements
are only of a communications nature -- shipping papers and vehicle placards.
The primary concern with creation of the combustible liquid class was proper
notification to fire personnel when a bulk unit of such materials was involved
in an accident.  Too many very burnable materials had been aovmg in tank
trucks bearing a "Nonflammable" placard.

    The suggestion in HM-102 rulemaking, that the class be defined by an upper
flash point limit of 140° like the U.N. definition, was not adopted because
there was no contention that liquids in this flash point range pose a safety
hazard in transportation.  As noted earlier, the shift from 3C3 to 100°?. also
was unsupported on safety grounds, but was adopted because of the consistency
thereby derived with the Occupational Safety and Health Regulations.  £?A's
recent adoption of an upper limit of 140°?. for its ignitabla vast a definition
is not based upon transportation concerns, but upon disposal site considera-
tions.  Thus, a ten-gallon pail of an I?A  ignitable waste with a flash point
of 12C37. will be not be regulated as a flammable liquid uncer DCT, but will
be consigned to the miscellaneous class of QRM-E, discussed aora fully below.

    i.9 CTS. 173.115(3) of the DOT regulations is one of the unique provisions
mentioned earlier, providing DOT with designation flexibility.  It reads:
experience or other data indicate that the hazard of a material is greater or
less than indicated by the criteria specified (in the flammable liquid defini-
tion), the Department aay revise its classification or naka the material sub-
ject to the requirements" of the Hazardous Materials Regulations.  A specific
product of concern to DOT at the tine of the HM-1C2 ruiemaking was nitro-
methane, which does not meet the flash point definition of flammable liquid
and yet had been involved in three major transportation explosions.  When the
flammable liquid class was redefined, this paragraph was inserted to provide a
published mechanism by which a material not otherwise fitting the class could
be forced into that class based upon experience or other data.  Presumably a
material could also be removed from the class, but to date tnis has not been
cone via this paragraph.

    The flammable solid class is described only generally in the DCT regula-
tions.  Under 49 CT3. 173.130, the tara includes "any solid material, other
than one classed as an explosive, which, under icnditicns normally  ir.cidant to
transpcrtaton is liable to cause fires through friction, retained heat froa
manufacturing cr processing, or which can be ignited readily and when ignited
bums so vigorously and persistently as to create a serious transportation
hazard."  This class includes spontaneously combustible solids and
water-reactive materials.

    is c ~_r, ;e  ;.aar.  ;TOC tnis  3erin.ition, "cere ire s.svera*  suoiective and

lr.li.-ii •. :iii w.p .--^r.ves  »lissif i cat it:.,  the assijrjsent cf  a material to tnis
class is entirely  at tae discrrttion cf ta& snipper of the  material.   Cf
course, towever,  if the material is classed by the Sureau cf  Explosives as an '
tAtl.-s:ve, ;.:  ie:-,ritaly cannot also be in the flammable solid class.  "Ja.der
~.T ..nta —:tr?.:ic-i, "conditions normally incident to transpcrtation"  do not
_-__^:.e ac-~.ce^t  :ircusstaaces, but do include the vibration  and abuse 2. mate-
ri.-.l •«!.. 1  receive  m usual  cargo trar-.spcrt.ati en.  In air transport theses con-
ii:i-ns also induce variations in pressure, temperature, and humidity :Lue to
rar.ic changes  in  altitude.   In land transportation they  include all
           :al  ccnditions likely to oe encountered, including  temperatures up

    Tie :a  are  three alternative elements to trie definition.   The material
^nier r. :rmal conditions must  pcse tae danger cf caus ing  fires through (1)
fr:-non,  C2)  ratamed heat,  or (2) ready ignition accompanied by vigorous and
;-c _--:."„ i. •: bu:"ur. g.  ^c,ie of  these elements of the definition has been
•7 ". c ,". ~ if .. J C .

    Tr.« spenfic,  inclusion cf water-react-.or. materials ir. the flammable solid
c.ast :.s tails ad '-~y  the DOT system of requiring a material to  fall withzji an
•*::iatu-.g classif-.caricn before it may ae regulated.  Vazetr-reactive materials
ire de::._-,ec ir -5  C!TR  1*1.3 as those vhicn through interaction with water are
_ik?»•"  *.c  bectxs  spontaneously flancsable or to ^ive off  flammable or tcixic
gists ,.r. dangerous  quantities.  Although a solid material that gives  c:f a
Tsxic ;;:2.s  »asn wet  coes not pose a f 1 amiability hazard,  for administrative
ccr.van..enr.e :~ has  been assigned to the flamaaole solid  classification,  in
adc;.ti.:nal r:'.*.ioriale  for this assignment is that the most likely sourca of
si.tr.if L'-ant c.iiar.titles of water in transportation is a fire hose, and -aming
fir a parsonn«l that the material becomes more hazardous  when  wet is the pri-
mary rurpose of  the regulation cf water reactive materials.   Through DCT's
recentlv acccted  four-digit hazard information system, emergency response
personnel  will be  advised tc  the specific hazards of the. material
' f lazmability  or  toxicity^  in a manual, .and in the interim  they will r.ot have
sprayed it with  water.

    The flanaable solid class if icato^,, because of its subjective nature and
its non-specific,  unquantified terms, has been one of the most difficult to
acm^nister for DCT and shippers.  It is presumed generally  that a shipper in
coubt will classify his material as a flammable solid  if for no' other reason
than to minimize  the  civil liability that might attach in the event of an
accident injuring third parties.  In essence, this class would be assigned as
parr ,;f the shipper's  duty of due care :;o others, regardless  of regulatory
    Many  necple have sought to quantify this  definition for their own, purposes
rr- having testing done by varous independent  laboratories.   It is known that
tre-. !:ure=w cf  Explosives will run tests and assign a classification i:l

requested by a contracting shipper.  For several years, DOT has had a low
priority project underway to quantify this definition, but implementation cf
such changes is years away.


    DOT defines an oxidizer as a chlorate, permanganate, inorganic peroxide o:
nitrate that yields oxygen readily to stimulate the combustion of organic
natter.  Here again, while the definition is somewhat acre specific than the
flammable solid definition, the terms still are subject to varying interpreta-
tion,  "or example, it is unclear what level the oxygen yield must be to
stimulate the combustion of organic matter to pose a danger in transportation.

    With both the flammable solid and oxidizer classes, many materials
recognized by DOT as being within these classifications are listed as such by
name in the alphabetical table of materials in  49 C7R 172.101.  when a
material is not so listed, the shipper must determine on his own data and at
his peril whether the definition and classification fit his material.   In =cs"
cases, guidance on the applicability of the rules will not ccme until aftar
the fact, i.e., after an accident or enforcement action leads to


    "CT defines organic peroxides in C9 CFR 173.L51(a).  The definition used
to be linked directly with that of flammable solids and cxidizers but, in
Docket No. HM-112, it was broken out as a specific classification to recognizs
the unique properties of these materials.  An organic peroxide is "An organic
compound containing the bivalent -0-0- stricture which may be con- sidered a
derivative of hydrogen peroxide where one or more of the hydrogen atoms have
been replaced by organic radicals."  Exceptions to this definition are
materials that have been classed as explosives, materials forbidden in
transportation because of their instability, aatarials meeting the definition
of flammable liquids not specifically assigned to the organic oercxide class
in 49 CT5. 172.101.

    In this classification, thera is another provision giving -CT flexibility
in their designation function.  This one is in 49 CF3 173.151(a)(-), saying
that any material meeting the definition of an organic peroxide must be so
classed unless "according to data on file with the Materials Transportation
Bureau, it has been determined that the aaterial does not present a hazard in
transportation."  This paragraph, unlike the one discussed azcve witn rsgarc
to flammable liquids, does not give the agency authority -a put aatariils
ir.to the class that do not otherwise fit.  It only provides a aecnanism to
caKe materials out of the class.  The phrasing of this is also different from
many of the other paragraphs on the same subject, since it only requires data
to be on file at DOT and does not appear to require an agency raspcnsa to
finding to ranove the aaterial from the classification.

                                                      tiuroasas in i9 "?R
„;,_-,.  i corrosive material.  is  a  -iquic or so. id that  causes a visible
obstruction or irreversible  alterations  in ruaan skin tissue a.', the site of
can-as.:: , cr ir. the case of leakage frco  its  packing a liquid that has a savers
c;:-:',£ 10;-. rate: en steel."  These general  descriptions are quantified by a
jpec,i';ic "k-hour rabbit skin  test and a corrosion rate test on steel giving
results ir. uvcaes per year  (0.250  I?Y) .

    This classification has undergone  fairly recant substantive revision  in
DCT's ruleaaking Docket No. Hh-57.   This  docket,  concluded in the early
19TO's, examined the quantification  of  the definition in light of specific
tests to be run.  HM-57 took the  fen  of  advanced notices of proposed rui-issak-
ing a^d several notices followed  by  an  amendment  and several corrective
acer.csents, each sak^ng significant  acjustments in the definition.

    Tbe rabb.t skin test  is described  in  Appendix A to part 173 of the DCT
r.:g"j ".2" ior.s .   It is similar to, but  not the same  as, a now Consumer Product
wtfity Ic::>s:is3icn test methodology for  skin irritants.  (See regulatory review
c: ."feceral Hazardous Substances Act  and analysis  cf generic hazard classifica-
tion:: ;,n Vcluiie .")   The  ?romin.ant factor in the  DOT test is that the ski;i
r.e-ic nr- :;>e  icrauec  and  consequently  niany materials that might be found
regulars:: uncer the ether tests ars  net regulated by DCT.  Tissue at the  site
cf caritac:: ziust be destroyed or changed irreversibly, and this has been
clcrif.ed by -CT to aean  actual necrosis  of the tissue.   Reddening or soreness
cr irritation that vill heal does  not  fall within this definition.

    "nder the rabbi": skin test an exposure period of four hours or lass i:s
pr«s ari'^e::.   longer periods were  proposed in the  early ruieinaking, but it was
ceter^mec by tae agency  that the likelihood of a transportation worker kuep-
;_'^ spili sd material on his hands  without washing for a period in excess  <;f
:rur r.cur: vas so small as  to not  warrant regulation.  The four-hour period  is
KST. ed to *.,he typical transportation  worker's day, where it is likely he will
was:; iidva.y t-rough the day prior to eating.

    ~~. the process of quantification cf the corrosive classification in Docket
No. H^.-ST, DCT considered and rejected a  pH test  as being a criterion not
sufficiently bread to cover ail materials that have a destructive effect  on
-.issue.  Notably, pH criteria exclude  purely organic chemicals (such as
isines";, and also do not  relate well on the basic (as opposed to acidic)  :>ide
cf the scile tc materials corrosion.

    For both DCT and EPA  purposes, the corrosion rate on szael is determined
by a recognised test of the National Association of Corrosion Engineers
'N'ACi,' .  jCT also proposed  that materials corrosive to alun.inum be regulated
IT, lane transportation but, for a variety of reasons including the particular
c;r.iarn v;.th sir transportation,  the aluminum corrosive qualification was not
aC - 3 ", i C. i',~ ,? 1 1 S3C CCS .

    The corrosive materials classification, as many of  those  already
discussed, includes a flexibility paragraph reading:  "If human  experience or
other data indicate that the hazard of a material  is greater  or  lass  than in-
dicated by the results of the tests specified in (49 CF3 173.240(a)),  the
Department nay revise its classification or make the material  subject  to the
requirements" of the regulations.  This paragraph, similar  to  that  found unde:
the flammable liquids classification, allows DOT on' the basis  of  data  other
than prescribed tast results to put a material in  or take it  out  of the clas-
sification.  Unlike the comparable oxidizer paragraph,  the  statement  clearly
requires some action on the part of DOT in response to  the  submission  of in-
formation on human experience, or other data.

    The corrosives definition revised in Docket No. KM-57 was  significantly
affected by international deliberations on a similar definition.   It  is known
that additional work on the corrosives classification has been cctnplatad in
the international forum and may result in changes  to the DOT  definition in the

    Regulation of corrosives, particularly those that are not  damaging to
human tissue, is one of the few areas where DOT clearly controls  aatsrials
because of a threat to property.  Historically it  is understood  that  the con-
cern with property in transportation focuses en damage  to transportation
equipment and on other packaged freight moving with the regulatac commodity.
There is no historical record that the transportation regulatory  ccncarn with
corrosive materials has ever extended to damage to the  environment, i.e,  dam-
age to natural resources that could not be considered private  property.

    Even in its regulation of property-corrosive materials, DGT's primary
concern has been the impact on transportation safety that might  be  caused
through destruction of adjacent packaging containing other  hazardous
materials, or the destruction of a structural element of a  transport  venicle
leading to a transportation safety hazard.  Mere damage to  adjacent
unregulated articles is a matter more appropriately left to commercial loss
and damage claims procedures and has not received  a graat deal of
consideration in the evolution of DOT's corrosive  classification.   Without '
question, development of the corrosive satarials classification  in  its
historical beginnings as well as in Docket No. HM-57 occurred  without  any
consideration of impact en the environment caused  by the spill of any
hazardous materials.

r~MC'3~~-~'3 "ACTS •'T-iwv
    . r.E. concern  *;cc.ressec  :nstcrica...7 Dy trie _C.  regulations  is safetv in
i ™?,~' rt iti-T. .  As  £  result,  tne £— s daf mition is  stated  in  terms cf ores*
;--•:- t.-.£t misst  be  encountere-d ur.cer conditions normally  incident to trarspcr-
--?,-. on.   .is noted earlier,  this inciuaes temperatures  up  to 130°?.   Within
th-..-. definition  are  materials  otherwise net considered gases,  but flammable
lie-ids s.avir.s :i high  vapor pressure when exposed  to tamper atures likely to be
<-.-: count*- ad m "r^r.spcrtaticn.  Cf course, any flammable  material not having a
• --ocr "assure :;•_:: ::icient ly higa to raeet the gas definition is regulated under
~:.t- flasa-b.e  1.. quids  class,

    ^est.ts the  fact that  the  section defines "compressed gas," this tern: is
n-t itself  -. r.l,iss-..f icatian.   A gas is classed either  as  a  "riannsable gas" or
"•-cn-f lasras-l-i <e i.cre  ".hiin  IS inches beyona an izrition source  with the container valve
coer, fully  or viz.i 3  flame flashing back arid burning  at  the valve with any
je?r -« o: vs'.v.«  c-senir.g,  C2; having any sigr.if icant  propogation of flame away
~~-r "he i;r-.i:ion  source  ^n the Bureau of Explosives open drum apparatus, or
;*  ;;:-ving an e;cplasicn of the vapor air ai::ture using the Bureau of
ixoli-sivss closed-drum apparatus.  These tests and apparatus are described in
icc'iaents avail.ible from  the Bureau of Explosives.

    Tr.e cr.ly  significant  difficulty in implementation  cf  this definition
r^lstes ~. 3 a  Lack  of data  involving vapor pressure curves cf flammable liquids
an", -r.ier cs:<2  :n  the  properties of gases at various temperatures.  While the
class.: ic.atioc  :s  within  the discretion of the shipper, the distinction be-
:veer. flasmarle  and nonflammable gases makes heavy use of Bureau of Explosives
t e-.icds   and the  Bureau continues to be  involved  in this function .
    Materials  regulated by DCT as poisons are  those  posing a very significant
 zreat to human  aealth when transported.  Materials  that might be regulat.ed by
ot'-er a2«:r.c:,a,-5 because of toxic properties  in  the  home or in the workplace are
 o . necessarily  ragl^-«d by DCT, since tne  hazard  to the industrial transpor-
;a;ion wor.or  a.2~  aot be present.  Within the  poison definition there ars;
:c.ree classes:   roisor. A, Poison 3, and  Irritating materials.

    Prison  A  is  defined in 49 CF3 173.326 and,  again,  the definition is not
raally a aefmition at all.  The section declares  that Class A poisons are
"'cisoncus  gases c-r liquids of such nature  :ha:  a  very small amount of the
jas  ~.r v^pcr  o* the liquid, mixed with  air is  dangerous to life."  Like many
cr t^e 1CT  cefmiticn sections, the true definition  is given by example rather

chan by quantitative criteria.  In 49 CTR 173.326 there ara eleven
specifically named materials that are designated poisons, Class A.

    Poisons that pose a lesser hazard are in the Poison 3 group, defined  in
49 CFR 173.343 as, "Those substances, liquid or solid (including pastes and
semi-solids), other than Class A poisons or irritating materials, which are
known to b« so toxic to man as to afford a hazard to health during transporta-
tion; or which, in the absence of adequate data en human toxicity, are pre-
sumed to be toxic to man because they fall within any one of (three
prescribed) categories when tested on laboratory animals."  The QCT definition
thereafter gives the following quantitative test methodologies,  for determining
oral, inhalation, and skin absorption toxicity:

    Oral Toxicity.  Those which produce death within 43 hours in half or
    acre than half of a group of 10 or more white laboratory rats
    weighing 200 to 300 grams at a single dose of 30 milligrams or lass
    per kilogram of body weight, when administered orally.

    Toxicity on inhalation.  Those which produce death within 43 hours
    in half or more than half of a group of 10 or acre white laboratory
    rats weighing 200 to 300 grams, when inhaled continuously for a
    period of one hour or lass at a concentration of 2 milligrams or less
    per liter of vapor, mist, or dust, provided such concentration is
    likely to be encountered by aan when the chemical product is used in
    any reasonable foreseeabla sanner.

    Tcxicity by skin absorption.  Those which produce death within 43
    hours in half or mora than half of a group of 10 or sore rabbits
    tested at a dosage of 200 milligrams or lass per kilogram body
    weight, when administered by continuous contact with bars skin for 2-
    hours or less.

     Once again, 3. paragraph is inserted in this definition to  give regulatory
flexibility to the Class 3 poison classification.  This cne reads:  "The
foregoing categories (of Class 3 poison descriptions) shall not apply if  the
physical characteristics or the probable hazards to humans as shown by experi-
ence indicate a substance will not cause serious illness cr death.  Nait.ier
the display of danger or warning labels pertaining to use nor the toxicity
tests set forth above shall prejudice or inhibit the exemption  cf any sub-
stances form the provisions" of the QCT rag-nations.  An example of aatarial
that may be relieved from regulation despite its technical inclusion within
the Class 3 poison classification is one shipped in units so small that a haz-
ardous dose for the nest foreseeable human exposure -ever is present m a
single shipment.  In this instance, compliance of the full scope of
regulations has bean considered unwarranted, ana regulation is  set applied.
     In contrast to similar paragraphs having to do with regulator
	:ibility, this paragraph does not appear to require the  filing cf  a:
material with DCT, nor any form cf ~CT response.  This paragraph gives

cisiretion to the sr.ipper cr  the  sataria-  to  aetemine whether ois orocuct is
r=g-l27sc :r not  regardless  of test  results.   Due- to potential for civil
Las-lity,  nowever  it is not believed  that tr.is  mechanism has beer, used
frequent;? by snippers of toxic material?  wi:.r.eut filing supportive documents
with the agency.

     -— .^Illj-l—g. _±-ler-A- is defined  in  40  C7R  173.381 as "*>. liquid or
sell- ?uss tar.ce vn..™ upcr. contact  with firs  or when exposed to air gives off
ccingercus cr -jntsniely irritating runes,"  such as certain specifically naned
materials out r.c.  Deluding any Class A pcisans.   This is a very limited class
aeiliz? prisaril1- *ith tsar gas,  chezici.1  aatr.in.ition, and other materials
—fracuer.:.IT eacs'-itarec in transportation.
     AT. eticlcgic or disease-producing  agent  is  defined by DCT as "A viable
-icroorgarisn, or its toxin, which  causes  cr  nay cause human disease/'  This
cefinitis:: is limited to specifically  listed  agents identified by the
Lepartneni: if Health and Hunan  Services  in ^2 CTS. 72..25(c).  Etiologic ag«r.ts
were net regulated  in transportation prior to 1960.  Amenca«nts to the
I.;tl^s;.-es and Cthdr Dangerous  Articles  Act (18  USC 321-325)  at that tine
n'rec: f i"=.I ly author lied direct  regulation  of  such materials.   DOT regulation
cf d^iolo,;:::.c agar~s to data has net been substantive,  but is a likely area fo:
"Normal fora radioactive material" means radioactive materials  that  ars  net
"special fora."  Special fora radioactive materials are those vhicn,  "if
released from the package, might present some direct radiation  hazard but
would present little hazard due to radiotoxicity and little possibility  cf

     Tie DOT rales on radioactive materials are essentially the sane  as  those
adopted by the International Atomic Energy Agency  (IAEA).  The  definitions,
other than the bare definition of radioactive materials quoted  above,  take  the
fora of specifically named materials or activity levels.

     Prior to amendment of the Explosives and Other Dangerous Articles Act  in
1960, the Interstate Commerce Commission (now DOT) ragulatad radioactive
materials as a Class D poison.  The classification did not smoothly  fit  the
nature of the hazard and authority was granted by Congress to clearly me
directly regulate radioactive materials in transit.

     The authority of the Department of Transportation significantly  overlaps
that of the Nuclear Regulatory Commission (NRC).  This overlap  is  addrsssad  in
a longstanding memorandum of understanding between the two agencies.   In
general, while direct regulatory authority exists within DOT to govern these
materials in transit, ti» designation function is performed by  nuclear experts
in NRC and in international regulatory bodies.

     The regulation of radioactive materials is one of the few  examples  cf  COT
concern extending beyond the threat of immediate or acute damage from mate-
rials in transit.  Wails long te-rm health effects  are net discussed  in the  DOT
regulations, clearly these effects have been considered by the  technical
personnel in NRC and IAEA who have defined many of the teras and cavelcpec  the
regulatory concepts.


     An "Other Regulated Material" is any aatarial that does not aeet the
definition of a hazardous material, other than a combustible liquid  in pack-
agings having a capacity of 110 gallons or less, and is specified (in -9 C73
172.101) as an QR.M material or that possesses one or aore of the
characteristics described" in the CRM-A, 3, C, D, or E classifications.

     Most of the CRM classifications were created  in Docket No.  HM-11I in
1976.  The classifications were to accomcc'ata the historical nature  cf tr.e  ZCT
system which requires a class before aatariais aay be regulated.   Since  all
other classes are cevoted to specific general hazards, thera was a r.aac  f:r
miscellaneous hazard classes.  For the most part,  thesa hazards ara  not
general in nature but are specific to given modes of transportation    In other
words, a material that is harmless in one node but dangerous in anctner, such
as an aluminum-corrosive liquid, is regulated in an CRM class so impact  cf  the
regulation can be focused on the acde in question.  Being a miscellaneous

                  i, the 3RM  classifications  ars  readily susceptible to
=_xpac.; _or.,  as evid.e~c.ed by recent  creation  of  the CRM-E class.

     The suffix letters cf the CRM classes  0.0  not convey any meaning, but are
merely IT. alphabetical sequence.   In  other  words, -the QSM-S class having to do
i.'tih environmental hazards has no  correlation  with the fact that '"environment"
   ins with t-e lifter "e."  It was merely  the designation next in line after
     CF.M-A  i3 a. material vhicn  has  an  anesthetic,  irritating, noxious,
icxic, or other similar property which can  cause  extreme annoyan.ce or
-iiscozfc-rt to passengers and crew  in  the event  cf leakage during
transportation. '  These materials  are particularly hazardous in a. cargo
transportation 'is.it tnat also encloses people,  passengers or crew, such a.s a
vessel or an aircraft.  GHM-A materials,  therefore,  are almost never subject
to regulation in truck or rail transport, unless  they are being regulatec
because cf tr.ei.r environmental impact as hazardous substances, or as
hais.rr.cus wastes defined 'under Section 3001 of  RCRA.

     The majority cf materials in  the 2RM-A classification would inrpair
breatnmg cr vision and are take fross a  sir.:.L.ar list  of materials that hs've
Dear regulated for vears in the international  air transportation field by IATA
>"":;t£—national Air Transport Association).   Under the IATA regulations, these
notarial.:, vers called ORA (Other Regulated  Articles).  Some materials foitnerly
-istac by the Ccast Guard as hazardous articles also  have come into the CRM-A
class.  In Docket No. EH-112, DCT  exaaied all  such IATA and Coast Guard regu-
"ated materials for their hazard potential  in  air or  water transportation.
Net all listings were adopted by DOT. Those included in the ORM-A class:.fica-
t..=r. are specifically listad by nane  in  49  C73  173.5G5 throgh 173.655, c:r fall
r*-;-,ir, d.  'CPJl-si, n.c.s." shipping description.   3RM-A, n.o.s., iteas ares not
spa- ,fic:-.;iy listed but pose the type of hazard described in the basic OK*-A
.tef _;nti::r .  The ORM-A definition  is  highly subjective and depends heavily on
the juagsent and caution of the shipper  rather  than on quantitative cricsiria.

     ORM-5 is another classification  adopted in the EM-112 rulenaking.  i^n
CSM-3 is defined in 49 C7R  173.500 as a  "material (including a solid, wh«n wet
with water) capable of causing significant  damage to  a transport vehicle or
vessel from leakage during  transportation."  Materials in the ORM-3 class; are
either specifically designated by  chemical  name in the alphabetical tabl« in
49 CTR 1"'2.101, or fall within the class based  upon the results of a giv«n
SACZ aluminium-corrosion test.  If a  liquid has a corrosion rate .in exce:;s of
0.15C mcnes per y&ar on aluminum  under  tnis test, and exhibits no other
regulatec hazards, it falls within the QRM-B classification.  This
classification generally is limited to substantive restrictions in air
trsn-.pcrtaticn  (although some also are regulated by water) and is keyed
directly to the potential to damage to the  aircraft or vessel if the material
'»erc t: .= t;.~l and aitack aluminum  structural members.  While the concern in
this --. es: gnat ion is orotection of  trooerty, it  is a property-protective

concern linked direcry to safety, since destruction of any structural member
of an aircraft or vessel has an obvious safety impact.

     An ORM-C is a "material which has other inherent characteristics not
described as an CRM-A or QRM-3, bur which made it unsuitable for shipment,
unless properly identified and prepared for transportation.  Each GRM-C mate-
riai is specifically named in 49 CTR 172.101 of the DOT regulations.  This
classification does not have an n.o.s. shipping name.  As noted in the defini-
tion, it is limited to articles specifically named in the DOT regulations.  To
a. large extant, these materials had been regulated under Coast Guard authority
under the tara "hazardous articles."  Understandable confusion between the
tarns "hazardous materials" and "hazardous articles" was one of the reasons
for changing the name of the latter.

     One of the purposes of Docket No. EM-112 was to bring air, water, and
land transportation regulations into a single volume of the Code of Federal
Regulations.  The air riles had appeared in Title 14, the water riles in Title
46, and the rail and highway rules in Title 49 CFR.  Upon consolidation of all
nodes into Title 49, with certain exceptions air-regulated materials became
CRM-A's, and water-regulated material became QRM-3's and ORM-C's.

     The hazard common to most ORM-C entries is spontaneous combustion.  In
other words, these are solid materials such as vegetable fibers, tankage,
metal borings, and oiled material that have a strong potential for spontaneous
heating and ignition, and when enclosed in a vessel in bulk in the presence of
humidity.  In other modes of transportation, unit quantities are smaller and
the environment is different and does not warrant the regulation cf CRM-C
materials.  Generally speaking these materials are regulated only in the watar
node.  An CRM-C regulated only in air transport, however, is magnetized
material.  An exception to these modal limitations occurs if an CRM-C material
also is a hazardous substance or hazardous waste under RCRA definitions.  In
that case, it is regulated in all modes of transportation because of its
environmental hazard, but is regulated under the QRM-C classification.

     ORM-D is a novel entry in the DOT regulations.  This classification did
not, in fact, have a predecessor class but is a new grouping of materials
created in the Docket EM-112 rulemaking.  An CRM-D is defined in 43 CFR
173.JOO as, "A material such as a consumer commodity which, though otherwise
subject to the regulations of this subchapter, presents a limited hazard dur-
ing transportation due to its form, quantity or packaging."  In ether words,
products in the CRM-D class are those which fall within definitions cr ether
general DCT classifications, but do not warrant substantive regulation.  The
strong contention that these materials may not warrant any regulation has
never been fully answered by the Department of Transportation.

     The only articles currently in the new CRM-D classification ara consumer
commodities.  "Consumer commodity'' is defined in 49 CTR 171.3 as, "A material
that is oackaged and distributed in a form intended or suitable for sals

tr.rcugr. retail sales agencies cr instrumentalities for consumption  by  indi-
vicvuals for purposes cf personal care cr nousenold use.  This  term  also  in-
cluces crugs and mecicines."  While the 3RM-3 classification is  not
structure.ly limited to consumer commodities, at tnis time these are the  c;nly
materia.s vitnm the classification.

     Net every consumer product falls within the classification.  The  consumer
product must be one for which general except;ons (i.e., small  quantity
exclusions^ ars pemittad  as listed in ->9 C~"; 172.101.  It also  must be within
packaging limitations for  the consumer zarke: as well as specific quantity
limits anc packaging types prescribed in --B C7H 173.120C.

     An article is reviewed first by its shipper for its hazard,  for example,
flammaciliry.   If, for example, the article is (1) a flammable liquid,  (2\  a
consumer commodity (as defined), (3) is granted exceptions due to its  small
size in various "limited quantity" paragraphs of the regulations (e.g. i3 CFR
173.11a(d;), and (i) is in specifically described packages less  than 65  Ibs.
gross weight,  it may be reclassifiec from the "laizmable liquid class into the
DRM-D c,a.;3,  ORM-D in effect, is a secondary classification for materiaij;
tr.dt primarily aeet basic  definitions but, cue to small size packaging and
regulation, imposed by other agencies (such as the Consumer Product  Safety Com-
m_s3ior.,, , need not be subjected to substantive DCT regulation  in transpcr"a-
cion.  Most, general DCT regulations do not apply to ORH-D materials and,  "o
the exten: there is regulation, it is distinctly related to air
transportation, not other  nodes.
     Hazardous wastes are defined by EPA under Section '3C01  of  the  Resource
and Conservation Recovery Act.  Z?A definitions implementing Section 3001
appear in iO CT?. Part 261.  It is clear from the statement of Congressional
interest in passage cf RCRA that control of hazardous wastes  in transportation
was envisioned., and that the E?A requirements on such transportation should be
consistent with those adopted by the Department of Transportation.   Implement-
ing tnis intent, DCT in conjunction wita Z?A proposed regulation of hazardous
wastes in transportation in DOT Docket No. HM-145A.  After a significant
consent period, Docket Nos. HM-I-oA on hazardous wastes  and  1453 on hazardous
substances were adopted by the Department of Transportation  on  May  22,  1930
(-5 7R 3iScO;.

     With the acsmistrative determination that DCT would administer the
transportation regulations for hazardous wastes defined  by E?A,  it  was  neces-
sary to create a mechanism for this regulation.  To simply establish a  new
classification would have been unduly confusing, since many  EPA-designated
wastes already were covered by the DCT regulations.  Basically  the  approach
followed by DCT in their rulemakmg was to overlay the DOT regulations  with
the £?A definition.  As a result, for example, any flammable liquid that was
alreacy regulated by DCT continues to be regulated in the flammable liquid

class,  but its properties as a waste are highlighted by container markings
by the waste manifest.

     Because definitions applied by both agencies are sot identical,  there  are
places where the EPA regulations apply and no DOT rules were in place.   In
overlaying the COT classes with the SPA waste definition, there was  extension
beyond the purview of the existing DOT rales at certain points  For  those
materials in this extended area that were unregulated prior to KM-1*5, DOT
created a new classification--ORM-E.  This classification is discussed mora
fully below but, in short, is made up of articles that are environmentally
threatening, but that do not pose a safety threat in transportation  under
traditional DOT definitions.

     Hazardous substances are also regulated by DOT now.  This was an error:
undertaken in Docket No. HM-145B.  Amendments adopting hazardous waste and
hazardous substance rales were developed concurrently and consequently are
somewhat coordinated.  Like hazardous wastes, the list of approximately  300
hazardous substances developed by SPA under Section 311(b) of the Clean  Vatar
Act included many items already regulated by DOT for their safety hazards.
Materials in all of the traditional classifications as well as many  in the
OKI-A, 3, C and D classes were designated as hazardous suastancs by  the  SPA.

     For practicality, DOT adapted EPA's definition of hazardous substance  to
fit transportation principles.  Under new 49 CT3 171.8, "hazardous substance"
for DOT purposes "means a quantity of material offered for transportation  in
one package, or transport vehicle when the material is not packaged,  that  --
(a) equals or exceeds the reportable quantity (RQ) specified for the  satarial
in EPA regulations at 40 CIS Parts 116 and 117; (b) is identified by -he
letter "S" in column 1 of Part 172.101; and when in a mixture or solution  in
any package offered for transportation is in a concentration which equals  cr
exceeds the following (based on the RQ weight quantities specified in -9 C~R

                        RQ           Concentration by Weight
     RC Pounds       Kilograms       Percent           ?PM

       5000           2270            10             100,000
       1000            454            2              20,000
        100             45.4          0.2            2,000
         10              4.54         O.Q2           200
          1              0.45         0.302          20

     The key element of this definition is that, at a minimum, cr.a dees  not
have a hazardous substance until the reportable quantity for that substance is
contained within a single.package.  3y this aechanism, DCT avoids the
applicability of unnecessary regulation to trace amounts of hazardous
substances that may be present but not in significant amounts.  Whereas  it  is
theoretically conceivable that trace amounts of hazardous sucstances  in  a  full

transportation unit, cumpec  in  its  entirety  ir.  a navigasie waterway, zignt in

Clear. i"c:te.r ,~c., DCT found tnat practical  experience in transportation
a. c clients ~a.ce tnis circumstance ur.  ikely.   It  is not impossible, but the
exrr&me burden upon transportation  carriers  in  particular, who would have to
ancnesati rally aggregate all trace  quantities  on one vehicle before moving,
nr.r  net fel:. vc:t»i,-c.ile in ligh: of  tne  goels to be achieved.  In a subsequent
FeciraL Rt?iste,r publication, ErA concurred  in  this interpretation of the
LH_:.-ir  .'its:: Act ::or transportation  purposes  (45 FR 61517).

     Ai with the hazardous waste definition,  the hazardous substance defini-
tion dex-alipec sy DCT was laid  over  the  classifications traditionally con-
tair.ec in the Hazardous Materials Regulations.   Requirements for materials
alreacy regulatec: by DCT by  name were  adjusted  to include a reference to the
repcrtasle quantity (RQ), to appear  on shipping documents and package mark-
ings .  Requirements for materials regulated  by  DCT but not by their chemical
nases wera modified so documents and package narking would include the E?A-
listed nase.  Rules applicable  to materials  in  the ORM-A, 3, C and D classifi-
cations ve.:e rod if led so that a material that,  is a hazardous substance or a
-dzardous vasts is regulated in all  modes  of transportation, regardless of
-.\<; -act tr.at :r its non-hazardous  substance cr non-waste fora it is only
r?v---tec in a«r o.- water ccEsierce,  An  ORM-A,  for example, that is covered by
i.is r.£zarc':u£ substance csfinition  now is  regulated as an ORM-A in all modes
of -.r2r.sfCTtarr.cn and must be marked and documented as an ORM-A hazardous
     As v.:n the hazardous  waste  definition,  the hazardous substance defini-
tion ;ic rat fit neatly  over  the  DOT regularad materials.   There were several
mctarials tnat cic not  fit  any  historic DOT hazard definitions.  For these DO"
has issigned the CRM-E  classification.   Tnis is the same class applied to haz-
arsou:" wastes that do not meet  another  DCT definition.   QRM-E as a new
c.,3ssif icj :on :s ciscussed  more fully below.

     1". vill b«i noted that  the  hazardous substance definition makes reference
;o tne le-:cer "Z" appearing in  column 1 of 49 Ci"R 172.101.  Use of this  lette:
conveys only the correlation between the word "environment," which begins witi
tna- letter, and has no direct  relation to the QRM-E classification.  Not
every itec. so noted fits the ORM-E  class,  nor is every item so noted
necessarily a. hazardous substance  if the RQ qualifications are not met.  The
letter "E" is merely a  signal that  environmental rules may apply, not that
they necessarily do apply.   It  is  a signal to the reader to look further.

     CRM"£ is a very recent addition to the DCT list of classifications.  It
was accptec in Docket No. HM-145A,  published in the Federal Register of  May
22, 1980  (i5 FR 34560).  Under  the  new  amendments, an ORM-E is a material
sucje.ct zz DCT regulation that  is  not included in any other DOT hazard class.
^a"aria,s ;.n the GRM-E  class now include hazardous wastes (as defined by EPA
ur.c.e: Sec-ion ."001 of RCRA) and hazardous substances (as designed by EPA but
defined by DC" ir. 49 CTR 171.8  of  the DOT Regulations).  The class is

structured to accommodate more materials in cha future, e.g., materials
reguiatad under Superrand, P.L. 96-510.

     Craaticn of the CRM-E class and other hazarous waste and substance  regu-
lations adopted in Docket Nos. HM-l«oA and 1453 are the first claar  entry  by
DOT into regulation of materials that are environmentally hazardous, but that
may not pose direct threats to people or transportation property.  A question
of the agency's authority under the HMTA to issue such regulations was raised
in comments en Docket No. HM-1453.  The answer of th agency, published en  May
22, read:  "The pertinent language in Section 311 of the Clean Water Act (33
USC 1221), £?A's autnority for designating hazardous substances,  13  contained
in paragraph CD)(4), which provides for extermination of 'these quantities  of
... any hazardous substances the discharge of "which nay be harmful to the
public health or welfare...."  Clearly, many of the risks involved  in tha
transportation of hazardous materials relate to the possibility cf
unintentional release, and such releases aay involve discharges into the
navigable waters of the United Statas.  To the extant that IPA has desi^r.atad
certain substances in specific quantities as potentially haraful, it is
appropriate for (the Materials Transportation Bureau) to designate those
quantities of those materials as hazardous materials under the HMTA.
Moreover, should MT3 not take this action, it would be left to I?A to fill  trie
void covering the transportation of those hazardous substances not  raac.-ed  by
DCT regulations.  Such a split in regulatory coverage wculc be inefficient  and
3. hinderance to all concerned."   (45 FR 34569)

     DCT's response to the issue of their authority does nothing  to  dispel  the
contention that there was uncertain basis in the HMTA, at the tine tnese rules
were adopted, for DCT to regulate environmentally hazardous substances.  The
designation criteria under the Claan Water Act and the I-IMTA ara tccall/  cif-
    Le lagal weight.  A hazarcous aatarial in the DCT statute is definec  as
one posing an unreasonable risk to health or safety and property, and that
definition has not been changed by Congress.

     The Comprehensive Environmental Heponse Compensation and Liability Act  of
1330 (Superfund),  Public Law 96-510, was signed by the Prasicant en Decamoer
11, 1330.*  Section 3C6(a) of this Act compels the Secretary o;
Transportation to list as a hazardous material under the HMTA, any r.atarial
designated as a hazarcous substance in the new statute.  The tara hazardous
substance in the new statute, of ceurse, includes acra than merely Section
311(3) Claan Water Act aatariais customarily described by that term.  Tha cars
now includes watar pollutants, air pollutants, materials receiving ittanticn
uncer T2CA, hazarcous wastas, and ether aatariils that aignt latar :e
designated as hazarcous substances by the Acministrator of I?A.  Listing  a
                    review inc.ucac in volume ...

hazarccui susstancs  in  -he  DCT  regulations fcr purposes of documentation and
no'ics, .icw ever,  a ay  not  be trie same as ar. alteration of the SiTA  statutory •
ds ir.itict of  sar.arcsus material.   The orcer in 3uperrand fcr  DOT  TO  list
I?,--cas;.rr.ac nsiardous  susstaacss  does not necessarily give DOT  "he dirs.ct
authority tc initiate the designation of materials that endanger the
erx-ircnaer.-, but  pose no  direct threat-to human health cr safety or com-
^.er-::-.", prop*.-~7  in transpe;-aticn,  as s. hazardoiis iuaterials.  .la  other words,
tn.« ?Iv~ri f-aru-cry criteria ranein unaffacted by the Scperfund Act.
    In ::rn;lisira,  under  the  HMTA the Department of Transportation  has  clear
authoritv to designate  materials  as aazaraous when transported  in commerce.
Thar, authority has  net  been used, except 1.1 rars .instances,  to  designates new
materials.  Rather,  DCT -^sad  its  authority to take materials  designated under
a pr^ce;:a£5or statute  in  a blanket adoption of those designations and
rsctii.~£::erts for  these  natarial?  as "new law" regulations.   (Docket No.
r?/-lj-. -. Fs 25 IT"  Sept,  ?,  1376.)

    !"..&;,£ .i .-x; iiirii.^shed aechanisx cr quantitative basis  upon which  DCT
=ic~s ;^. lesigr.ctica of  materials.  The aatsrials oust be  classed before being
re^ul^te.;. ar.r the  classes themselves are ambiguous, subjective, inconsistent,
s.~2 ret. iuscapt irsl*  to  rsadv  ce*miticn or quantification.   There is no basic
-issicn s-ateoent cr policy position guiding the agency or the  public on DCT
actions uncar the ?2frA.   Tae  process is subjective and informal and musi: be
viewed ., ith a certain  degree  of skepticism by those who would prefer a
quantitative, consistent  apprcacn to controls >

    T:;e prirsry value  of  the  DCT systsc is that it is there,  and within its
ior.t-rTt it \s faziliar  to people  who ara regulated by it.  Without  question,
-r.e esr.y '.~ru:t  ~-f regulation cf materials in transit dealt with the acute
                  jf  tae  materials.   New that DOT has embarked  on the designa-
tion  (c.r at  least  the  listing^  cf materials that pose  environmental hazards or
long  'certs 'ita..ta hazards,  it is unclear what limit there  is  to the HMTA

                     U.S. COAST GUARD--REGULATORY REVIEW
    As noted ia the Statutory Review, the Dangerous Cargo Act, 46 USC  §  170,
was developed to augaent the statutory authority in the Explosives  and Other
Dangerous Articles Act, 18 USC § 331-335.  The latter statute applied to
shipners by all modes including water, but needed to be statutorily extended
to water carriers .  The authority under the Dangerous Cargo Act is  exercised
by the United States Coast Guard, a part of the Department of Transportation.

    The Dangerous Cargo Act required the Coast Guard, in exercising this
authority, to accept and adopt the "definitions, descriptions, descriptive
names and classifications" adopted under the Explosives and Other Dangerous
Articles Act.  Those designations of hazardous materials now occur under  the
successor statute, the Hazardous Materials Transportation Act, implemented by
the Department of Transportation with input from the Coast Guard.

    In DOT's rulemaking Docket No. HM-112, completed in 1976, regulations
applicable to water transportation of most packaged hazardous materials were
relocated from 46 CTR into 49 C?R Part 176.  Many of the provisions unique to
water transportation were removed to that Part and also are reflected  in  the
creation of the QRM-A, QRM-3 and ORM-C classifications discussed in the HMTA
regulatory review.  Not all Coast Guard regulations cf materials, however, ara
addressed in Title 49.  The Dangerous Cargo Act still supports regulations
appearing elsewhere in the Code of Federal Regulations.  These and other  Coast
Guard regulations dealing with hazardous substances are discussed below.
    One active area appears in 46 C7R Part 146 entitled,  "Transportation or
storage of military explosives on board vessels."  In Subpart  146 . 2C , the
Coast Guard sets out detailed regulations governing explosives.  Explosives
here are defined as they are in Title 49.

    This coincidence of classification definition, however,  is somewhat
misleading in the regulations en handling military explosives.  It was found
that the csnmercial regulations for ocean shipment of explosives and ether
hazardous materials were too restrictive for vessels that wars cevotad to
transportation of ammunition, such as those operated for  the military.  The -9
C~R regulations simply do not provide enough alternatives for  the loading and
stowage cf explosives to satisfy the needs of a vessel  for military  axplcsives.

    Consequently, in 46 CTR 146.29-100, there is  in entirely different systam
of "classification" of explosives.  These classifications ara  fsr tne purpose
of segregating materials to assure compatibility  and to designate stowage
locations aboard amaunit ion-carry ing vessels.  Thus, for  example, one finds
Class I made up of small arms amauz.it ion (without explosive  bullets),
denotating fuses, DOT Class C mechanical time fuses, and  like  it arcs.  Class

,,-:•. .: ::-r.e  ...  --.-  nu..-: prcpe_-£rts  s,ucr.  as  3a.--is.i-e, cordite,  propellant
r_.:*T'=>j   -,c.  ';.-.-e-...p  Dag cnarges  in  cutsi.de snipping ccr.ti:;_r.ers.   Class IV
.,-::... .r.:-,:.  •_".--.  ,;;.-:  £?;::.-fixed ;.=unition  wit:: explosive loading  projectiles.
1,-ii.',  ", .I;  -„ ,  -....es various i^r.e  fur.es, ilascing caps and detonators.   Class
X-C  induces  ~u_c:ed missiles anc.  solid  propellant zctors packed  with or w:.th-
cut warsni=ads.   Class XI-3 includes  non-lethal chemical ammunition.   Clas:;
'-.'I-- -5-re^ ;.~; i;.~;»rs _r containers  for guided missiles and  rockers.

     .r,t±s\: vnjri»*—s  zr&c~assirications , ecus —c— m& sa^cs or s^&da-.M^&d c«^..ca— y
-ranspcr-ri^icc..  say cr nay act be  ;sr.sisres.r wi-"n -he criginal Class A, 3 and
w ~ — ^3 c iji"., ca~icns  ^eve^oo&c 1*1 »11 — 3 -^7 anc  Te-&irsncec in . .1— _e  "+0.   ^ne *r i^ic^s
A, B ar.c  .1  explasives ail included  in  several of the military  classifica-
tions   I;:  Class XI-D mentioned above,  the "cxicizers" are classed  under Title
49 as  tor.rosive liquids, ncn flarsable  gases and oxidizing materials without
ar:" of  tr-sa being  classed as Title  ^9  explosives for sooanersial  pu:rposes.

    This  .s an  escteric area of classification developed for the specialised
use cf  =i.li.T.ar:,' shipments of acnunition.   It is oriented toward  the loading
?-:,'«  stow_.:•?, of  rateriils to aiz.:.ffii2:e incidents in transportation where this
76ss«-  is filled *ith a variety of  explosives.  Because of its liaitec
=.pp .-iacility.  it  11 net discussed  in  greater depth.
    Part  l.'C  of *6 "JSC authorises the  Coast Guard to develop  regulations :o
control trie us_e of hazardous naterials  aboard vessels.  These regulations are
published  in  -6 CFR Part Ii7 and are entitled, "Regulations governing use of
cancer.;.,:.  ="tic,l-s as ships' stores and supplies on board vessels."

    "h;.-*3  stc- = s and supplies ara -defined in 46 CFR 14.7.02-1 as  "any article
cr sues :.£••.;-  wr..ci :s '.isec on board a  vessel subject to the regulations of
. tne Coas:. Caere) for tae upkeep and aaijatenance of the vessel;  cr for the
safety  or  comfort of the vessel, its passengers or crew; or for  the operations
^- navi?a::ion of the vessel  (except fuel for its own machinery);  except siip-
rscir*  r.iJ..ia>;,,cr," Tegulatei  <>isewhere.   46 CTR 14.7.02-2 defines  ships' stores
''of &  can>rers-s nature."  For the purpose of these regulations,  materials with
''suea  aa.ari,cterist;ics properties as will cause the substance  to  properly clas-
sify as e:.ther an explosive, inflaamable liquid, inflammable  solid, oxidizing
material,  corrosive liquid,  compressed gas, poisonous article, hazardous arti-
cle or  ccsibustiile liquid in accordance with the definitions  for  such sub-
stance  zz  ccntainfed in the regulations  in this subchapter are defined as
sh.i?s   stores arid supplies of a dangsrous nature."

    Because of & r-erias of rulesaaking  actions elsewhere over  the  past few
years,  t.r.:.s cefin-tion is incomprehensible.  For exanrple, at  the  latter por-
uion of the quota where it speaks of definitions of substances  as-contained
"in this,  >u- ihapc-ir," one finds there  ara nc- such definitions in the sub-
chaptar c :i.ti.ir.:^..- these regulations today.  This is a vestigial  reference to
A 5
liquid and solid ara now outdared.  In Tide 49, oxidizing  materials  ara
called oxidizers .   "Hazardous articles" ara chose that became  GRM-A,  GR_M.-3  or
ORM-C in Title 49.  Combustible liquids at the tine this  regulation was devel-
oped meant liquids with a flash, point of 30°?. to 150°?,  whereas  today in
Title 49 that definition begins at 100°F. and goes up to  200°F.   There is no
reference whatsoever to the new OJW classifications.  In  short, the regula-
tions on ships' stores and supplies are fatally defective and  give  Little
illustration of what is required.

    In practice, it is understood that these rules apply  to all articles
classed as hazardous material in Title 49.  This is not written anywhere .  It
is merely known in the regulated community and by the Coast Guard.

    These regulations are more akin to occupational safety  and health rales
than to hazardous materials transportation riles.  The reference  to the 3 07
regulations, therefore, perhaps indicates a deficiency in these riles.  There
are many hazards encountered in the use of a product that are  aot prassnt in
transportation and, therefore, are not addressed in the DOT "riles in  -*9 CFR.

    The handling of various regulated materials that do not need  to be spe-
cially "certificated" or approved by the Coast Guard is addressed in
46 CFR 147.05-100.  The materials are described and by their various
properties are limited in use.  These properties may or may not coincide  with
elements of the 49 CFR classifications.  For example, the definition  of
combustible liquid in 49 CFR extends from  100° to 2GO°F.   End use  regulations
in Title 46, however, often refer to goods with flash points of 1.3 03F.
Hazardous materials not covered by this table are intended  to  be  identified as
in 49 CFR 172.101 and require special Coast Guard cartif icatisa before they
nay be used en board vessels.  Some materials ara not permitted for use,  but
this is not written in the regulations.
    The Dangerous Cargo Act includes authority  for  the  Coast  Guard to  regu-
late shipments of bulk solid hazardous materials by vessel.   Section l"C(6)(a;
of the statute prohibits transportation of bulk solid hazardous  materials  or.
board any vessel unless authorized by Coast Guard regulation  or  other  special
authorization.  The term "hazardous materials"  for  these  purposes  is defined
in 46 C7R 143.01-1 to mean hazardous materials  as defined in  49  CFR Parts
170-39.  Materials listed in Section 143.01-7 by the Coast  Guard as authorized
for carriage  include a variety of flammable solids,  oxidizing aararials  ar.d
CRM materials, as veil as lew specific activity radioactive materials.   Ir.
acdition to the specific listed articles permitted  oy regulation,  tnera  _s a
procedure for seeding special permission to carry oulk  soli
orocadure is  outlined in -*6 CFR 143,01-9 and.  153.31-11.

    -cast 3w.s.rd regulation  of hazardous  materials in bulk tankers and barges
3c;_r= under "_„»£  iccsacn. 7  references  as  Succaapcer 3 and Suochapter 0 regu-
lations.  iu.3Kiar.-er D, made up  of  Parts 30-40 of 46 CJTR, addresses liquids
anc liquefied gases bearing  the  hazards  of ::1 amiability or combustibility, but
without additional hazards.  Generally these are hydrocarbons.  Suhchapter 0,
aa-o up cf -6 CT'. 111-154,  addresses  cheaicai bearing ether hazards that may
IT c. luce f laaziariliry and  combustibility  as well.   Each Subchapter prescribes
requirements, but tnere is  heavy cross-referencing between Sub-chapters for
ie-iinitions  and other requirements.

    Within Subchapter D,  Part 30 contains  general requirements; Part 31,
genera, inspection and certification  rules ::or tankers; Part 22., special
equipment. machinery, and hull requirements;  Part 33, lifesaving equipment;
Part i-, firafighting equipment; Part 25,  tanker operations; Part 36, elevated
temperature  cargoes; Part 37, special construction, arrangement and other pro-
visions for  nuclear vessels  carrying  flammable cr combustible cargo; Part 38,
liquefied and compressed  flammable  gases;  and, Part 40, special construction
arrangement, and ^her provisions for carrying vinyl chloride in bulk.

         n Subchapter 0,  Part 151 addresses unmanned barges carrying certain
         srcus .i-irgoes; Part 152, safety rules for self-propelled vessels
         nazarcaus liquics;  and  Part  154,  sarety standards for self-propelled
•vessel:, carty-ing bulk liquefied  gases.

    Regulations en unmanned barges  are  issued by the Coast Guard under the
authority of the Dangerous  Cargo Act, 46 I'SC 170, as well a.s 46 USC 39la.  The
uncanned oarge .regulations  are set  forth in 46 CTR Part 151 and contain uni-
fsrs sminus requirements for transportation of liquids or liquefied gase;s in
bult:  ctr.er  tiian flaanaables  and  combustibles regulated unde^.r Subchapter I1),
m.-luding r.2far-.2ls not regulated under  the HJfTA.

    As v-..th  the regulations  in ships' stores and supplies, the regulations on
unmanned barr-as also suffer from inconsistencies and inaccuracies relatec. to
ruleaakirig changes elsewhere.  For  example, in 46 CFR 151.01-1 there are  lists
ci iargo«:s aftected by these regulations and the list includes hazardous  arti-
cles now properly classified as  ORid-A,  3 and C materials.  There are many sec-
tional cross-references to  regulations  that no longer exist -- predecessors to
hazard definitions now appearing in 49  CTR.  The requirements on unmanned
barges dc: not. involve the designation of hazards, but cross-reference
cesignaticns nade elsewhere in 46 CTR and in 49 CFR.

    Coas:: Guard regulations  in 46 CFR Part 153 on bulk chemicals aboard sielf-
prope-led vassals,  issued jointly under  46 USC 170 and 391a, also adopt she
hazarr.c'is tsterials classification definitions published  in 49 CTR.  An ssxcep-
zictj to "-his =rs definitions of  flammable and combustible liquids that appear
in -c ~~i 153.1.  There,  a  flammable liquid is defined as it is in  Subchapter
D. :.- -6 C7R 3C.1C-22, and  a combustible liquid as it is  defined in 30.10-IS.

     The referenced definition sections are published as part of "he Sub-
 chaprer D.   The definitions in Subchapter D predate changes that took place in
 HM-102 and continue to draw distinctions and limitations from that aarlier
 period.  These are the defin.'":ions applicable to bulk tankers (including
 manned and unmanned barges).   46 C7E 30.10-22 defines a flammable liquid as,
 "any liquid which gives off flammable vapors (as determined by flash point
 from an ooen cup tester as used for test of burning oils) at or below a
 temperature of 80°?."  Flammable liquids are referred to by grades as
 follows:  (a)  Grade A, any flammable liquid having a Reiad vapor pressure of
 14 Ibs. or more; (b) Grade B, any flammable liquid having a Reid vapor
 pressure under 14 Ibs. and over 3-1/2 Ibs.; and (c) Grade C, any flammable
 liquid having a Reid vapor pressure of 3-1/2 Ibs.  or less and a flash point of
 30*7.  or below.

     46 CFR 20.10-15 defined combustible liquid to mean, "any liquid having a
 flash point above 30°?. (as determined from an open cup tester,  as used by
 test of burning oil)."  In Subchapter D, combustible liquids also are rafarrad
 to by grades,  as follows:  Grade D, any combustible liquid having a flash
 point below 150°7.  and above 80a?.; and Grade E, any combustible liquid having
 a flash point of 150°?. or above.

     The flammable liquid definition here stops at 30° ?., as it used to for
 land regulations before Docket No. HM-102 changes.  The combustible liquid
 definition is interesting because of the classficication of combustibles below
 1-30°?., rather than 200°T. as in 49 CT3.   Even more importantly, regulation
 as a combustible liquid occurs with any material with a flash point frcn
 150°?. to infinity.  This means, for example, that aolasses in a bulk tanker
 is shipped as a combustible liquid.

     Materials listed in Farts 30 and 153 nay be carried in bulk (vhan the
 vessel is certificated for such carriage by the Coast Guard) as long as the
 published rules are net.  Materials not listed by name in either part aust be
 made the subject of a special application for a Coast Guard certificate, in
 order to be carried in bulk aboard any self-propelled vassal or tank ship.
 There are no published criteria upon which such a certificate is granted or

     Coast Guard rules on self-propelled vessels carrying bulk liquefied gas as
' are issued under the authority of 46 CSC 391a, and ara published in 46 C7R
 Part 154.  la 46 CFR. 154.3, a liquefied gas is defined as a cargo having a
 vapor pressure of 15 psi or acra at 37.3aC. (100°?.).  The regulations provide
 for carriage of specific listad gases.  This list was developed over time froa
 known gasas for vhich a great need, was fait or gases that were specifically
 requested by individual applicants to be aoved in bulk vassal operations.   The
 list is in Table 4 3f Part 154.

              'flaaenable cargoes' is defined  in  -*6  CF3  154.3  as  including "he
r> 11 owing gases ::rce Table ^:                                      •

         aieta-denyde             Ethylene oxide
         Butadiene                Methane  (ING)
         Butane                   Methyl acetylene-propadiene mixture
         Burylene                 Methyl bromide
         7, laeth'*'.. u.:.ine            Methyl chloride
         £-nane                   Propane
         "L ihy-dsijie               Propylene
         iisy. m.oriae            vinyl  cnloriae

    "Tcxi;. cargoes" are defined to mean  the  following  liquefied  gas.es froc.
T ab s 4

         Acataldehyde             Ethylene oxide
         Anhycrcus ammonia        Methyl brocide
         I'isecsy Lasine            Methyl chloride
         I thylamina               Sulfur dioxide
         Itryl chloride           Vinyl  chloride

    ::atsr:.als re.julated in bulk include  all  "hose  falling within the defir.i-
zioa cf 2 hazarccus material as well  as  other  combustible liquids.   For the
shipment of a hazardous material or a mixture  of hazardous materials that is
net authorized specifically by name in these various parts of Title 46, it. is
necessary to go rhrough a special approval process  before the vessel nay be
certificated by :ha Coast Guard to carry the material.   The process may or may
not result, in the issuance of a certificate.   Generally  speaking the applicant
for certification is subjected to  a variety  of requirements that are keyed to
the given material.  It has occurred, however,  that certification has been
aen_ec for materials too dangerous to be carried in bulk.   There is no
assurance that tae conditions attached to issuance  of  a  certificate would be
witnin tne realm of economic feasibility.  It  does  not appear that in mak:.ng
thase cetsrsinations, the Coast Guard uses any published criteria.   Each
decision :.s a case unto itself, and decisions  are  made on an
applicatisn-by-application basis.


    Under the Ports and Waterways  Safety Act,  33 USC §  1225,  the Coast Guard
has issued regulations published in 33 CTR 126 pertaining to the handling of
explosives c~ other dangerous cargoes within or contiguous to waterfront
facilities.  46 CFR 126.07 defines dangerous cargo  to  mean all explosives and
other hazardous materials or cargo covered by  regulations of the Coast Guard
in -6 CFR 23-23, 146, and 148.  In addition, the definition includes hazardous
materials except those preceded by an "A" in Title  49  CFR Parts  170-179.
Those preceded sy an "A" in the hazardous materials table, of course, are only
regulated by air (unless they are  hazardous  wastes  or  hazardous  substance;.).

    33 CT3. 125.10 lists  cargo of particular hazard  ,  acting  those  of higr.
hazard such, as explosives and others that pose  a  significant  dar.gar in bull<
quantities.  Under these regulations, the primary concern  is  the  safety of the
waterfront facility.  Judging by the materials  regulated under  Part 125,  it is
clear that the acute injury potential caused by fire  and explosion  are the
priaary concerns in establishment of these regulations.  The  aechanisai of con-
trol is the issuance of permits to people engaged in  activities  involving
hazardous materials coming to or being held at  waterfront  facilities.


                        FOOD AND DRUG ADMINISTRATION
    The Food and Drug Administration is responsible for the implementation cf
several statutes authorising the regulation of chemical substances, including:

         Federal Food, Drug, and Cosmetic Act
         Pesticide Chemical Act
         Food Additives Amendment
         Color Additives Amendment
         Drug Amendments
         Animal Drug Amendments
         Medical Devices Amendments

    The legal reviews and regulatory analyses that follow do not necessarily
represent the official position of the FDA or the Department of Health and
Human Services.  Moreover, this material has not been officially endorsed by
the EPA as its understanding of FDA authority.

    The FDA statutory and regulatory reviews focus on the health and safa.y
aspects of FDA authority and do not consider the FDA's powers vxth respect ~o
product efficacy, standards of product purity, accuracy in labeling and ether
issues apart from the regulation of risks to health and safety posed by
chemical substances.

                    FOOD, DRUG. AND COSMETIC ACT OF 1938

    Responding to increasing public awareness and growing political pressure,
Congress passed the landmark Pure Food and Drug Act in 1906.''  The bill
aimed to protect  consumers and to insure the purity of their purchases by
p-uohibxting the sale of adulterated or misbranded foods and drags.  By  1933,
hcwevsr, changing conditions had sada the bill obsolete.  Moving  to revitalise
Consumer rntection in the area, Congrass replaced the old law with the
Federal Food. Drug, and Cosmetic Act (FDCA).1 •

    The new Act retained most features of the older legislation but greatly
expanded its scope.  For example, coverage was extended to cosmetics5 and
therapeutic devices* (medical devices) for the first time.  The Act also
stipulated that drug manufacturers had to prove that their new products wara
safe before they cauld be aarketed.5  In addition, the legislation  increased
fovemaer.t's enforcement powers by authorising factory inspections,'
"2C!uirmsi companies to maintain records cf interstate shion
•?.=rscwerir.g courts to enjoin violations.*
    lJune 30, 19C6, ch. 391.3, 34 Stat. 763.

    zJuae 25, 1938, ch. 675, 52 Stat.  1040, codified  as  21  USC  §301  et
sec.  When it was passed, the FDCA was statutcrily  administered by the
Secretary of Agriculture.  3y regulation, however,  administration  cf the law
was transferred within the Department  to the Food and Drug  Administration
(FDA).  In 1S4G, the FDA was transferred to the Federal  Security Agency, and
in  1953 to HEW.  With the creation of  the Department  of  Education  in 193C ,  HEW
•was ranaiaed the Departaent of Health and Hunan Services.  Over  time, actual
administrative authority has remained  with the FDA.   For simplicity, the
statutory analysis will use the word "Secretary" instead of identifying the
particular Secretary and Department which had authority  at  any  one ti;

    3:: '.;sc §§ :«1-353.

    *21 JSC I 351 e_t sec.

    sll JSC § 255.

    S22 'JSC § 3''i.
     i -
      22 "3C  3  222.


    In another major step, the FDCA provided that an added "poisonous or
deleterious substance" could be safely present in foods under carefully
regulated conditions.9  Previously, any food containing an "added poisonous
or deleterious substance" was automatically considered "adulterated"--even if
'.he concentration of the substance was so small that the Secretary believed
".hat no health hazard existed.  The FDCA moved away from this absolute
approach.  Instead, it allowed the Secretary to permit a specified tolerance
of a deleterious substance in a food if (a) it was required  in production or
could not be removed by good manufacturing procedures, and (b) it did not
exceed a level that endangered public health.  This provision was Congress'
first recognition that a potentially toxic substance may be  safely consumed in
small, carefully regulated concentrations.  The idea is now  widely applied
throughout the Act; the Secretary may approve the use of raos~ chemicals  as
long as they are safe for  intended use.  In fact, when approving most types
of substances, the Secretary must specify the conditions under which they may
be safely used.

    Since 1938, the basic  FDCA has been substantially augmented.  Major  amend-
ments have extended government control over food  and color additives,'
.pesticide chemicals on raw agricultural commodities,11 drugs and animal
drugs,12 and medical devices.13  Those amendments, outlined  in Exhibit
3-1, contain the Food and  Drug Administration's  (FDA) primary powers to
identify and regulate toxic  and potentially toxic substances.  Following a
discussion of  the definition of hazard and the  general mandatory reporting
requirements specified in  the FDCA, the major amendments to  the statute  will
be examined.

Statutory Criteria  for Regulation  and Factors  for Regulation

    The FDCA regulates the safety  of  foods, drugs, medical devices,  and
cosmetics.   Potentially  toxic  chemicals  specifically  covered include any "food
additive,"  "color  additive," "drug,"  "animal  drug,"  "pesticide  chemical  in  or
on  raw  agricultural  commodities,"  and  any  "poisonous  or  deleterious  substance"
In  foods, drugs, medical  devices,  or  cosmetics.   Statutory provisions  relating
to  each  of  these substances,  summarized  in Exhibit 3-2,  will be  carefully
explored  below and  in  the  following  sections.   The regulation of  efficacy of
drugs,  product purity,  and the  like,  is  not  considered  in  this  review.
     921 USC § 346.

     10Sept. 6, 1933, Pub. L. No. 85-929, 72
 L". No. 86-618, 74 Stat. 399.

     xlJuIy 22, 1954, ch. 559, 68 Stat. 511; July 12, 1960, Pub. L. No.
 86-618, 74 Stat-.  397 .

     120ct. 10, 1962, Pub. L. No. S7-781, 76 Stat. 781-783, 7S4, 7S5, 796;
 July  13,  1962, Pub. L. No. 90-399, 32 Stat. 343,351; Oct. 24,  19oS, PUD. :
 No. 90-639, 82 Stat. 1361, 1362.

     1JMay  28, 1976, Pub. L. No. 94-295, 90 Stat. 575.

                                 EXHIBIT 3-1

                       HE ?QOD, DRUG. AND COSMETIC ACT
                            AND MAJOR AMENDMENTS
Act or Amendment                                  Yaar Enactad

"cod, Drug, and Cosmetic Act                      1938

Pesticide Chemical Act                            195<*

Tood Additives Amendment                          1953

Color Additive Amendment                          1960

Drug Amendments                                   1962

Animal Drug Amendments                            1963

Medical Devices Amendments                        1976

                  EXHIBIT 3-2

Chemical on
Raw Food
New Drag
N'ew Animal
Prohibited if
or Unsafe










X (some)
Mandatory Delanev
Reporting Clause

0 0

0 X

0 X
0 C
X 0


X 0
X = Required
0 = Not required

    ""::€ }"~.:Z.-. tax.es ax. extreme.;-* cautious  approach  toward the iaentiiication
i^id resulitior. cf potentially toxic  substances.   In  general,  new substances
coverec D" tc.e Act are presumed to be -unsafe  and  are prohibited from
ir.carst.it:1 commerce ur.less the Secretary  has  approved and act withdrawn
appr-va. if the use of the substance.  Examples include approval of a new drag
2pp.lic3tiir.  'NIA), an investigaticnal new dreg  (IND) notice and certification
or releasi of drugs containing insulin or antibiotics (see also note 115
below;.  Tood and color additives, pesticides used on agricultural
camcod-ties, bus an and animal drugs, ane  medical  devices are all subject to
this approach.  Tr.e only cneaical substances  covered by the Act which are not
pras-^ifcc ~c be unsafe are those which are used  in  cosmetics.   If-the FDA
aeterziae; tnst any such chemical is "poisonous or deleterious" however, Lts
use may oe, regulated or prohibited as an  "adulterated" cosmetic. 14  In
Helens Curtis_Egterprises. Ino. v. ?ruitt,xs  the  Fifth Circuit Court of
Appeals stated:   'In order for cosmetics  to be  'adulterated,' they must cause
hara under conditions of use which are prescribed by the directions or oust be
used in trie customary and usual fashion."
    The Act discusses safety standards only  in  the most general terms.  The
approach is typified by the food  additive provisions.   For example, no food
acr.it.ive aay se aarketed in interstate cccaerce until  a regulation approving
its -se h.is beer, issued.1'  The Secretary cannot approve s-ach a regu- lation
unless "a fair evaluation of the  data  .  . .  establish[es]  .  .  .  that the
prcpcsed use of the food additive, under the conditions of use to be specified
i^. the re-julatic-n, will be safe".17  Similarly  broad safety standards apply
to substances throughout the Act,  except in  the case of carcinogens.  More
restrictive clauses, inserted  largely through the efforts  of Representative
Jdsres Delaney, aandate that food  additives,  color additives, and new animal
drugs aay not be approved as safe if they are carcinogenic.11   Proponents of
the clause reason that because the mechanisms which cause  cancer are unknown,
    '-'21 "JSC § 343.
              I  342(c)(3)(A)  (food  additives);  21 USC § 376(b)(5)(3).(color
add_tives), 21  'JSC  §  360b(d) (1) (H)  (new aniaal drugs).  An exception to t.he
Delaney clause  permits  the use  of  a carcinogenic food additive in aniaal
feeds.  Such  an additive may  be approved if it does not adversely affect the
anical fed, and if  no residue of the additive  is found "in any edible portion
cf such animal  after  slaughter  or  in any food  yielded by or derived from the
living animal."  21 USC §348(c)(2)(A).   This exception also applies to
carcincganic  cclor  additives  used  in animal feeds and carcinogenic new animal
c.~gs. I: l'SC i276(b)(5)C3);  360b(d) (1) (H) .


no safe tolerance can be set for carcinogens. Thus,  the Secretary may net
permit even small amounts of carcinogens to be prasent in foods or animal

    Because of its wide coverage, the FDCA has been the subject of much
litigation.  Again and again, the courts have held that the Act is to be
broadly construed.11  These are the oft-cited words of the United States
Supreme Court:

          The historical expansion of the definition of drug, and
          the creation of a parallel concept of devices, clearly
          show, we think, that Congress fully intended that the
          Act's coverage be as broad as its literal language
          indicates -- and equally clearly, broader than any strict
          medical definition might otherwise allow.  .  . .  But we
          are all the more convinced that we must give effect to
          congressional intent in view of the well-accepted
          principal that remedial legislation such as the Food,
          Drug, and Cosmetic Act is to be given a liberal
          construction consistent with the Act's overriding purpose
          to protect the public health, and specifically, § 507's
          purpose to ensure that antibiotic products marketed serve
          the public with 'efficacy' and 'safety.IJ3

This liberal construction has colored the judicial opinions in this area and
is reflected in many of the decisions which are cited in this statute—/ revia'.

    Although the ?DCA has been interpreted broadly,  it has not been interpre-
ted to affect the administration of other statutes.   In Continental Chemista
Corporation v. Ruckelshaus,81 for instance, the Seventh Circuit Ccurt of
Appeals held that merely because the use of an economic poison in compliance
with directions on the label caused certain food to become "adultaratsd" unde:
the FDCA did not mean that the poison was "misbranded" under the Federal
Insecticide, Fungicide, and Rodenticide Act.

    Exhibit 3-3 contains a brief description of the safety determination and
FDA action which must occur before a regulated product can be marketed.
    11 See, for example , United States v. An Article cf Drug  .  .  .
Bacto-Unidisk, 394 U.S. 784  (1969), rah, denied, 395 U.S. 954  (1369); Ag?
                                                                 ' .
       > rah, denied, 355 U.S. 917  (1969); United _Statas "  S'aremco .  Inc.,
'553 F.2d 1133 -(3tn Cir. 1977); Maserey v  Unit ad States, —7 F_2up? . 5-8
(D.C. Nev.  1377).

    :3 3act3-Cnidisk. supra ,  394 U.S. at 793.

    21461 F.2d 331 (7th Cir.  1372).

                                 i:~-:i2:T 3-3

Pesticide Chemicals  "    A tolerance for residues on raw agricultural
                          consBod.ities must be set "to the extent necessary  to
                          protect the public health."
                     «    The level of the tolerance is based on a  broad
                          cost/ benefit analysis which examines the economic,
                        J  environmental, and health effects  resulting  fr«m  use
                          of the pesticide chemical.

Food Add;.tives       •    A regulation must be issued "prescribing  the
                          conditions under which the addit:.ve may be saf«ly
                     •    The regulation is based primarily  on  the  safety
                          risks of the additive.
                     •    Generally, the maximum permissible concentration
                          of the additive must be 1" or less of the
                          concentration which produces no effect .in
                          experimental animals.

Color Additives      •    A regulation must be issued "prescribing  the
                          conditions under which the additive nay be saffily
                     •    The regulation is based primarily  on  the  safety
                          risks of the additive.
                     •    Generally, the maximum permissible concentration
                          of the additive must be 1% or less of the
                          concentration which produces no effect .in
                          experimental animals.

New Drug             •    A new drug application may only be approved  afi:er
                          the FDA determines that the drug  is safe  and
                          effective for use "under the conditions prescribed,
                          recommended, or suggested in the proposed labeling."
                     •    Approval as safe is based on a balancing  of  this
                          therapeutic risks and benefits of  the drug.

                                 EXHIBIT 3-3

New Aaimal Drug
Medical Devices
A new aniaal drag application may only be approved
after the FDA determines that the drag is safe and
effective for use "under the conditions prescribed,
recommended, or suggested in the proposed labeling.1
Approval as safe is based on a balancing of the
therapeutic risks and benefits of the drag.

For Class III devices, the FDA must approve the
device after determining that it is safe and
effective "under the conditions of use prescribed,
recommended, or suggested in the proposed labeling.'
Approval as safe is based on a balancing of the
therapeutic risks and benefits of the drag.

Ho FDA approval is necessary before a casaetio cr
cosmetic ingredient may be marketed.
If the FDA demonstrates that a cosmetic cr
ingredient is a "poisonous or deleterious"
substance, then it is considered adulterated ar.d
barred from interstate commerce.


          Resortins Requirements
    Befsra z. saanuf acturer or processor can marks-  a  food  containing an added
chemical substance, or distribute a drug, aninal drug, or medical  device,  he
must petition the Secretary to approve the food additive, drug,  animal drug,
or device as safe.2"  The petition must carefully  identify  the  substance ::or
which approval is sought and fully report all information pertaining to the
safezy of tne item.23  Any study or investigation  which indicates  that the
item nay be unsafe oust be included.2"

    Generally, anca the Secretary has approved the use of an  item,  furthe::
inforaatirn concerning possible dangers or safety  violations  does  net have to
be reportad.  There are, for example, no statutorily mandated reporting
requirements for incidents concerning food or color  additives or pesticide
chp.c-Lcals on raw agricultural products.  Cosmetic  aanufacturers, who do not
need to obtain preaarket approval for their products or ingredients, are also
not sandated to report safety violations or incidents.  The Act  does require
the manufacturer cf any approved drug, animal drug,  or medical  device to
report any information he obtains which may indicate that the regulated i:esn
is unsafe.  (See Exhibit 3-2.)  Similarly, he must report any information
concerning the safety of a. drug, animal drug, or medical  device, which is
exespt fr=n the general approval process because it  is being  used  solely for-
investi^aticnal uu
    :I21 USC  §§  3^8  (food  additive),  355  (drag),  360b (animal drug), 360*
 (device).  Efficacy  issues  are  not  included in this  review.


    Hi a Pesticide Chemical Act25 was designed to modify and es.la.rga  a pro-
vision of the 1933 FUCA which was underutilized by the government ana food
industries.  The original FDCA allowed the Secretary to approve the  use of  a
"poisonous or deleterious substance" in a food if the substance was  required
in production or could not b« avoided by good manufacturing practice.is
When granting an approval, the Secretary was to prescribe a maximum  concentra-
tion for the substance in foods "to such extent as he finds necessary for the
protection of public health."17  Before he could set the concentration
level, the Secretary had to hold formal public hearings and snake detailed
findings concerning safe residue levels in foods.  Unfortunately, the process
was lengthy and cumbersome.  As a result, while most pesticide chemicals would
have been considered poisonous or deleterious on foods, only one formal toler-
ance for a pesticide was set between 1938 and 1954.  Instead, industries and
the govemnent followed unofficial tolerance levels.2*

    Recognizing pesticide chemicals as uniquely necessary "poisonous and
deleterious substances", and wishing to afford greater protection to the
public health by simplifying and speeding up procedures regulating such
substances, Congress enacted the Pesticide Chemical Act of 1954.:s   While
the older provision cnly allowed the government to regulate pesticides which
had been identified as "poisonous or deleterious," the new section automati-
cally covered all pesticides.3'  In addition, the bill prescribed specific
time limits for regulatory review to assure that petitions for approval would
be evaluated expeditiously.5:

Authority for Regulation under the Act

    In general, the FUCA is administered by the Secretary of Health  ar.d Hunan
Services through the Ccomnissicner of the FDA.  Since 1970, however, the
Administrator of EPA has overseen the use of pesticides on raw agricultural
commodities.  Petitions for approval are submitted to the Administrator who
must first certify that the pesticide is useful and then evaluate its safety
and set a maximum tolerance for the substance.
    "July 22, 1954, ch. 559, 68 Stat. 511, codified as 21 USC § 3ioa.

    1121 CSC § 346.
    2*S. Rep. No. 1635, 33rd Cong., 2nd Sess. , reprinted  in U.S. Coca Ccr.z.
and Ad. News. 2526-2623 (1954).
    J121 'JSC § 346a(d) .

             :r. a:ose m Ir.-ircnnigntal  jefar.se:  Fund  v.  U.S.  Department of
                  C A^ — 0 — ;
.-_* ' wnetner tr.& Secretary or r_iw    r,ac  to wait  untii  trie secretary or
Agriculture ieregisterec. D2T before HEV could  establish sere tolerances
i* ,   The court hfcld that HZ,*' did net  save  to wait,  saying:

         While it is obvious that the responsibilities  of the two
         Secretaries are interrelated and  ought to  be coordinated,
         we think their individual responsibilities are quite clear
         and quit-; separate.  The Secretary of HZV  is given the pri-
         ssrv responsibility for determining the  amount of residue
         sf a pesticide which cat: safely  -- from  the viewpoint of
         the food consumer  — be left en  raw agricultural commodi-
         ties.  It is true  that in establishing a tolerance, the Sec-
         rrtary of HZV must take into account  the Agriculture Secre-
         tary's opinion regarding the agricultural  usefulness of the
         pesticide, but that is only  one  of many  factors which HSV
         oust consider.  In cur judgment,  the  Act's language re-
         quires taat HZW sake its own independent judgment, based on
         public health consiaerati'ics, as  to the  tolerance which
         siaould he set for  pesticide  residues  on  raw agricultural
         cotciacdities and not. abdicate its  responsibility to the
         Desartm«m; of Agr: c.u.1 ture . 3 *
    The a^'snded TDCA covers  any  "pesticide  chemical" that is "used in the pro-
cac.t--.cn, storage, or transportation  of  raw  agricultural commodities. "3S  The
tens "pesticide fchssical" aeans  any  substance which, alone or in combination
with any other substances,  is  a  pesticide as  defined by the Federal Insecti-
cide, Fungicide, and Rodeaticide Act (FTJRA).'!   "Pesticide chenicals" in
processed feeds are net  covered  by this section.   They are treated as "facie
additives" under Section -.09 of  FUCA.37

Statutory Criteria and Factors  for Regulation

    Any "pesticide chemical" used on a  raw  agricultural commodity "shall be
deemed unsafe" unless:
     3I42S F.2d  1033  (D.C.  Cir.  1970).

     33Now. Health  and  Hunan  Services.   See note 2, supra.

     3"42B F.2d  at  1087.

     3821 USC  §  321(c).

     3S  Tb_..d.  FirRA  is  found at 1  USC  § 136 et sec.  See the statutory
and  regul,stjrv  reviews  of  that  Act.


         1.   The Administrator has set a tolerance  for the chemical
              on that commodity,

         2.   The Administrator has exempted the chemical  from  a
              tolerance because "such a tolerance is not necessary
              to protect the public health," or

         3.   The pesticide is "generally recognized as safe"

    In setting a tolerance, the Secretary should liait the concentration  cf
the "pesticide chemical" on the food "to the extent  necessary to protect  the
.public health."7'  The Administrator should at least consicsr:

         1.   the necessity of the chemical to the production of an
              "adequate, wholesome, and economical food supply,"

         2.   other ways in which the consumer may be affected  by
              the same or similar substances (i.e.,  other
              exposures), and

         3.   the usefulness of the chemical."'

Pesticide chemicals in or on a raw agricultural commodity  ara net coverac by  a
Delaney-type clause.  The court in Inviror.gier.tal Defense Fund v. U.S.  Depart-
ment of rZV,>; said, "[W]e do not think the Delaney  anticancer  amencaent
can be held to apply full force to pesticide chemicals."   That  court  also quo-
ted both the Senate and House Reports on the Pesticide Chemical Act:

         Before any pesticide-chemical residue may remain  in or on a
         raw agricultural commodity, scientific data must  be presen-
         ted to show that the pesticide-chemical residue is safa
         from the standpoint of the food consumer.  Tne burden  is en
         the person proposing the tolerance or exemption to estab-
         lish the safety of such pesticide-chemical  residue.1*2

Thus, the court concluded that if a substance is found to  be a  carcinogen, the
Secretary may permit tolerances for it greater than  zero,  but he would :'be
recuired to explain the basis on which he determined such  tolerances  to be
     "21 USC § 246a.

     3'21 USC § 346a(3).


          F.2d 1083,  1091  (D.C. Cir.  1970).

     ilFootnota emitted.  i2S ?.2d  at  1092.

          :._,ir.: »., 3 »az~3  the Administrator  to  approve the use of £ pesticide
         ;z n igr; cultural  icrsont"  zust  prove that  the substance is s_a.fe
          LUis,-" i~ e   •"'*e *""--- sur~;.t  £  petition containing:
          ^A.s  tse name, checical  ide-Ci™,  and  zosroositias of the
              pesticide chesicai;
              vtsticide che: ;.cs.l

         (T':  r.,.1 reports  cf  investigations  made  with respect to
              ~,-;e  safety of  the pesticide  clerical;

         £2",  tie  results cf tests  on  tha  amount of  residue remain-
              ing  [on commodities],  including a  description of the
              analytical aethods  used;

         flj  practicable methods of removing residue which exceeds
              s.^"  rTopcsed  ts.erance:

         ','?';'  proposed tolerances for  the  pesticide  chemical if tol-
              erances are proposed;  and

         '""  reasonable grounds  in  support  of the petition.kfc

The Hist:ct cf Columbia Court  of  Appeals,  in  Environmental Defense Fund v.
C.5. jqrdrtser.t of HZ'*',** cocoaented  as  follows on  these requirements:

         Beth House  and Senate reports  emphasize that the formal
         requirements for a petition are to  be flexibly administered
         in the interest of safeguarding the  public  health:

                   1 It is intended  that a  rule of  reason
              should dictate the  nature and  extent of the
              information which should be  submitted  with a
              petition,  vfnat  is  contemplated is data ade-
              quate  to permit  an  accurate  appraisal  of
              safety ~s protect the  public health.  In
              this respect  the data  as  to  a  particular
              s.haaioal will depend  upon many  variable fac-
              tors,  including  its physical and chemical
              properties, recommended  purpose, toxicity,
              and  rate of disappearance.   The emphasis to
    '"I! "SC  §  3-6a(d)(l).

    *sroctncte  omitted.   i2S  ".2d 1082,  1089 (2. C.  Cir. 1970)


              be placed on any such factor will similarly
              depend on the particular pesticide chemical
              under consideration and its proposed us-
              age. * * *'

So Mandatory Reporting of Incidents

    Once a pesticide chemical has been approved for use and tolerances have
baea set, the FDCA imposes no mandatory requirements to rsport incidents or
contaminations concerning the substance.

    £.Lr.:c e  -5;£, th*-,  FDCA  "rchibitad the use c:! unsafe substances  in  food.
rrxcr ":• l:i<:, oeiore  the use  of s. cangerous cnemical could be banned,  how-
ever, tzis  fece.ral government had to prove it was "poisonous or deleterious."
C-nce a suspicious chemical was  identified,  it often took two years or more to
cocp.ete, sci£n':il_c  testing  to'prove whether tae 'substance was unsafe."'*
Durir.: :.r.at  .-e.riod,  unscrupulous food procetscrs could ccntinue to use  the

    ~: acdrass tne csngerous situation, Cor.grass passed the Food  Additive
iaencae--  of  1953" '  which shifted the burden cf srcof to processors  by
requiring  then to descnstrata  that an additive was safe before it could be
used.  This  action net  only  extended further protection to consumers, it also
aiced hcaest  f:cd processors.   The great majority of processors--accounting
:or i~ percen- cf -occstuffs producec--conducted their owa. safety tests for
food ac:iitives.  "Jntil  trie passage of this  aaancaear, they were subject to
unfair price  cscpetiticn  frsa  the processors vho ignored safety considerations,
•• i_s£li.---  £ irst£T ces  .everas

    T*e ;i.:ier:c3:2r.': srcacly  defines  "food additive." as "any substance  the  inten-
ded ute ci which results or  aay reasonably be expected to result,  directly or
indirectly, in  its  Decoding  a  cotsponent or otherwise affecting  the chars^cter-
isti-.:s cf  any food.""'  Substances which are generally recognised  as  safe
(GRA3; by  scientific  experts  are a major exception; they are not considered
food additives.*5   This GRAS  provision was added to exempt substances  from
scientific safety testing  if  their safety aad already been deaicnstrated  by
long tars  coscacn use  in food.*'   The term "food additive" also  excludes
"cclor .-cc-itives, '*   certain  pesticide chemicals, and substances which  hsive
been previously  approved unaer the FDCA, tae Poultry Products Inspection Act,
or tn

    Any radiation used in producing, manufacturing, packing, processing, pra-
caring, treating, packaging, transporting, or holding food  is also  considered
a food additive.Sl  Lika other food additives, radiation nay not be used
without regulatory approval.

    Tne legislative history sheds some light on the intended coverage of the
food additives provisions.  The Senate Report on the Food Additives Amendment
of 1953 stated:

              The legislation covers substances which are inten-
         tionally added to  food.  These additives are generally re-
         ferred to as 'intentional additives.'
              The legislation also covers substances which  may rea-
         sonably be expected to become a component of any food or to
         affect the characteristics of any food.  These substances
         are generally referred to as  'incidental additives.'
              The principal examples of both intentional and inci-
         dental additives are substances intended for use in produc-
         ing, manufacturing, packing, processing, preparing, treat-
         ing, packaging, transporting, or holding food.
              Gn the other  hand, substances which may accidentally
         get into a food, as for example, paints or cleaning solu-
         tions used in food processing plants, are not covered by
         the legislation.   These additives are generally referred to
         as  'accidental additives,' since these substances  if prop-
         erly used may not  reasonably be expected to become a compo-
         nent of a food or  otherwise to affect the characteristics
         of  a food.  If accidental additives do get into food, the
         provisions of the  Food, Drug, and Cosmetic Act dealing with
         ooisonous and deleterious substances would be applica-

    Several  courts have had occasion to rule on the scope of the substances
covered by the term "food additive."   In considering a product called Jarro-
Lac, the Fifth Circuit Court of Appeals held:

         It  does net matter under the Act if Fsrro-Lac is in fact
         safe or whether the residues would be different if the
         individual ingredients were tasted.  Tne sole criterion
         for identifying a  food additive is whether a substance
         wnich may become a component of or affect the
         characteristeics of any focd be not generally recognized
         anong Qualified experts as having been shewn to be safa, 11
         USC § 221(s)."
     *J  Ibid.

     "S. Rep. N'c.  2^22,  3;th Cong.,  2nd  Sess. ,  r«-=rintec  in  ". 5.
Cong,  and  Ad. Sews,  5200, ;202-52Ci  (1953).

     5''Zmchasis  added,  "nitad  Stat?^  v.  — 1  Casas.  Mora  cr Lass,

                                        . rrer . ' '  tne  court  ::e_c taat rooc-
                                        focc  additives.   The court stated:

         The orcfdly ~rctscti*/e intent  cf  this  legislation antissrs
         :r" "e legislative history thereof,   The  Sensta Co~~ittae
         rspcrt contains the statement,  'We  want "he record to show
         tnat in cur spinier. the bill is aimed  at preventing the
         addition to the food our people eat  cf  any  substanoes the
         ir.^est ~.'.T o; which reasonable  people wo-ld  exsect to t>ro-
         iu,-£ -ot ;ust cancer but any disease or disability.'   Sen.
         ?.p-.. No. :-I2, £Sth Cong., 2d  Sess.  (1552),  3  U.S.  Cade
         ;=nr_. a^d Acrin. News. p. 5310  (1958).   The legislative
         history furtner estab.ishes that  the House  subcosrittee
         analvring the bill considered,  and  ejeplicitly  rejected on
         the ground of surplusage, a proposed aaendaient that wou'ld
         have brougnt  'food additive1 within  the definition, of
         'food.'  The subconcittee spokesman, Rep. John sell
         Wi_lians, stated:

              'It was the feeling of the Cocaitcee that
              such a provision would be  surplusage since
              the Present Food and Drug  law,  in  section
              201(53 [21 U.S.C.A. § 22lCf)3  already  de-
              fir.ei "food" as including  all  cctnpcnents
              thereof.  Since substances which  gat into
              fscd incidental Iv in its  aanufacture ,  hand*
              ling or packaging would be dealt  with  as  a
               'food additive" under the  bill, there  ap-
              peers to be no need  to  have  such  substances
              also defined as a  "food."'"

A later case. Monsanto Csaroany v.  Kennedy,57  set some limits on what food
paikagm;; ~ar- be  rounc; to oe fnoc  aacitives.  The District of Columbia Court
of Appeals ^elc triat the FDA nay net  find  that  food-packaging aaterials seccae
a component of the food contained  in  it  merely  on the basis of the diffusion
principle, '.'hich  states that "any  two substances that are  in contact will
tend to Diffuse into each other  at a  rate  that  will be detersmec as a
function of time, texpersture, and the nature of the substances" . s *   The
ccurt fo^nd that  "Congress did not intend  that  the component requirement of a
'food adcitive' would be satisfied by a  mere  recitation of the diffusion
principle, a mere finding of any contact whatever with food."*'
    3538= ?  Sure.  79i  CD.:. Mass.  1975),  affiraed,  525 F.2d 1103 (1st Cir.
13"-). cart, denied, i29 U.S.  819  (1976).

    5*Sciae citations omitted.   289  I.  Supp.  at  797.

    s'6i: ?.2d 947  (D.C. Cir.  1979).

    5!E=-:.hasii ir, original.  612 F.2d  at  955.


     Other cases hava interpreted the coverage of the food additives provisions
 rather broadly.  For example,  in United States v.  Zwjg 3ros. Co.. Inc.,'3
 the Court held that DDT and dieidrin found in smoked fish were fccc additives
 despite the fact that these substances were in the raw fish even before tne
 soaking process began.   In National Nutritional Food Association v.
 Kennedy,*'  the court upheld a regulation wnich allowec vitanins anc mine-
 rals in dietary supplements which are not generally recognised as safe to be
 treated as  food additives.  In so ruling, ths Court also held that a substance
 nay qualify as a food additive even if it also qualifies as a food under the

.Statutory Criteria and "actors for Regulation

     Following the preventive principles of the FDCA, any food additive is
 considered unsafe unless the Secretary (1) has approved a regulation gcvarr.ing
 the conditions under which the additive "may be safalv used" or (2) has
 granted an exemption for investigational use by qualified experts.'J  The
 court in United,,States  v.  Articles of Feed . j.j. Buffalo Jerky82
 interpreted the effect of this section as follows:  "The language of the
 statute establishes a presumption that the food additives ara unsafe unless
 one of the  exceptions is established."

     When evaluating the safety of a "food additive," the statute directs the
 Secretary to consider at least:

               (A)  the probable consumption of the additive and of
          any substance formed in or on food because of the use of
          the additive;

               (3)  the cumulative effect of such additive in the
          diet of man or animals, taking into account any chemically
          or pharmacologically related substance or substances in
          such diet; and

               (C)  safety factors which in the opinion of experts
          qualified by scientific training and experience to evaluate
          the safety of food additives are generally recognised as
          a-ocrooriata for the use of animal experimentation data.11
     '"502 F.2d 715 (7th Cir.  1374),  cart,  da^iad, -20 U.S. 9-5 (1375).

     !::i use § 3^3.

     *:i56 F. Supp. 207, 213 C-.C.  Nebr.  1573).

     <<121 'CSC 2 343 (c) (5).

.r.e concept ~r surety was or  signincant  importance to rae legislators  in
                                  .        .                 ~       "
               The concept of  safety used in this legislation in-
          vrlves the question  of whetner  a su.3S~aijce is hazardous ~c
          :he health of man  or animal.   Safety requires proof of a
          rssonaola certamry  chat  no b.ara vill result fram the pro-
          pcs*c -use cf as. additive.   It  does ^ot -- and cannot --
          r-.cuire prscf bevcnd arry  possible iouot that no h

Information Required for Approval

    When submitting an application for approval of a food, additive, the appj
cant's petition nust include:

              (A)  tie name and all pertinent information concerning
         such food additive, including, where available, its chemi-
         cal identity and composition;

              (3)  a statement of the conditions of the proposed use
         of such additive, including all directions, recommenda-
         tions, and suggestions proposed for the use of such addi-
         tive, and including specimens of its proposed labeling;

              (C)  all relevant data bearing on the physical or
         other technical effect such additive is intended to pro-
         duce, and the quanitty of such additive required to produce
         such effect;

              (D)  a description of practicable methods for deter-
         mining the quantity of such additive in or on food, and any
         substance formed in or on food, because of its use; and

              (I)  full reports of investigations made win respect
         to the safety for use of such additive, including full in-
         formation as to the methods and controls used in conducting
         such investigations.'*

No Mandatory Reporting Requirements

    Cnce a food additive has been approved for use, there ara no statutory
requirements to report incidents or contaminations concerning it.
      '21 'JSC § 343(b)(2).

     Prior  ;c  r.-e  tsssag-e of -'-.e 2clor Accitive  Amendments of 1?60,!9 the
Co^ri^t.o'.vEr  of "n^ n.A nac certified 11;  color additives for use in foods,
~..:.gs,  cr  i-:;;:t.t ..i-.  "   Z~..~ 19 of tr.css colors,  however, were approved  for
,-iSc  in  :«c;r.$   crugrv.  znc ccsccetics,  As sciar^tific  testing methods improved,
t.-.e  .-Ji  oscan to  receive information wnicn  indicated that many approved  colors
were toxi:  under  certain extreme conditions.  The original FDCA prohibited the
~ ~~~- .r_- st ion ::~  ,'.".7 unsafe color; and the  saf ?- for -intended-use approach,
c..i:: ,?-  ;:,L  : ~N: c  a.d;t_vt;s in 1936, did r.ct  cover color aaditives.  As a  re-
"-'-"•  '••>•  Cr=c.is.,_ r.ar  had to ce-'-artif" sevtr,  ::; the 19 colors with unre-
strict'it  =op:ov= ..   ^.cre ce-certif icstiins were expected and industries  began
to  :aer  ttat  it wsulc be lapossihle to find  the approved colors they needs.d
for  foocs,  cr-_gs,  and cosmetics.  Political  pressure, began to build for  action
sirilar  tc  tae food additives amendaent whicr. would allow the Secretary  to
approve  a  color acditive if it was safe for  use in  a specified manner and
-itnin  set  to.ar.ances.   Tnese pressures were supported by a 1956 National
Academy  c:'  Sciences study which had recoEtaended such an approach for the  regu-
    .- r.r-.'-.r  s: j^-ilur;  for the li'.l was the specific  plight of the citrus  in-
— '-""•"•     s~  IS'-.  -n'«estiga.tions revealed that  Red  Dye #31,  the color us;ec   -
o.  gr.>.ers  to  eye  naturally greenish nature oranges,  was toxic under soae
cor.; it ior.£..  ~:;c-gn  it  was safe for coloring oranges,  the ?DA was statutoriiy
forci-i to  cscertif"  t.ie color because it was not  safe undar all ccnditionsi.

    Througz  sp«c_al  legislation, Congress allowed growers to continue using
-.r.e cy? -.arpcrari.1y    In 1959, further legislation substituted the newly de-
*->lwTec lt:C  I'ya  .;2  for  .?32.   The new color was  itself toxic under seme condi-
- ,on. . -u;;  rosed a  Lesser t.-r^at than ^32.  T.ie legislation specified thai: Red
                            :til iugust 1961, -unless Congress; took further  ac-
    li. '. Sr:C, the  Color Additives Aaendaent resolved  the problem.  It moved
avc?" free, "ha  absolute requirement of safety  and  permitted the Secretary ':o
•••irtif" f, color  for  use if it were safe under conditions which he prescribed.
The aaensiier-  furtner  required that each "batch"  of  a  dye ba certified by the
Secretary as sife fcr  use.
       u.ly  12,  1960,  Pub.  L.  Nc.  86-618, 74 Stat.  399,  generally codified  as
           ~ t.
    ""Thi'i paragraph  is  generally from H.R. Rep.  No.  1751,  36th Cong., 2nd
iess .  , r_e?_rint.ed  in U.S.  Code and Cong. Ad. News,  2887-2391 (I960).

      *7he following three paragraphs were developed  generally from S. Rep.
No. :?;, -:oth  3cng.,  1st Sess.  (1959) and K.R. Rep.  No.  1761, 36th Cong.', 2nd
Sess,, -_rrr_int_e_d  in 'J. S.  Code Cong,  and Ad. News  2887  (1960).


Cheaical Substances Covered

    '«hiie the original FDCA covered only coal-tar based colors, the  amended
Act regulates ail color additives.  The statute exempts materials whicn  izpart
color but are used solely far other purposes:

         The tern 'color additive' means a material which--

              (A)  is a dye, pigment, or other substance made by a
         process of synthesis or similar artifice, or extracted,
         isolated, or otherwise derived, with or without intermedi-
         ate or final change of identity, from a vegetable, an-imal,
         mineral, or other source, and

              (3)  whan added or applied to a food, drug, or cos-
         metic, or to the human body or any part thereof, is capable
         (alone or thrugh reaction with other substance) of impart-
         ing color thereto;

         except that such term does not include any material which
         the Secretary, by regulation, determines is used (or inten-
         ded to be used) solely for a purpose or purposes other than

For example, pesticides and nutrients which color as a side effect are nat
covered by this section; they are regulated in separata provisions of the Act.

Statutory Criteria and Factors for Regulation

    Any color additive is considered unsafe 'unless (1) it is approved for the
particular use by the Secretary and comes from a certified "batch" of dya or
batch that has been exempted from certification requirements, or (1) it  has
been granted an exemption for investigaticnal use by experts 7:  Because of
the small number of colors used in foods, drugs, and cosmetics, tnera is no
need to exempt some colors froa the approval process by creating a generally
recognized as safe (GHAS) category similar to that 'used in the food additives
provisions.   In evaluating the safety of a "color additive" the Secretary must
consider at least the following:

         (i)  the probable consumption of, or ether relevant expo-
         sure from,  the additive and of any substance formed in or
         on food, drugs or cevicas, or cosmetics because of t.ie use
         of the additive;'
    T121 CSC § 221(t)(l).  In 21 CSC § 321(tj(2;, an exception from this
definition is made for certain agricultural chemicals that affect colcr :
as a by-product of their main function.

               ;_i;  trie  cucu.ati-'e  errect,  ir  any,  cr sue:: ac.citive
         ir. t2e iiet  cr  nan  cr  inirials}  tar.ir.g into account "he same
         cr £.-;-• chemically or pr.araaco logic ally related subs ranee cr
         2UDsc.arr.as in sue::  diet;                   "         " *      ~

               i:ii;   safety  factors  which,  12.  t' :  opinion cf experts
         qualified by scientific  training  and  experience to evaluate
         tae safety of colcr additives  for  the use  cr uses fcr which

'w w OI M* * *. v^ O

    Cosmetics were not covered by the 1906 Pure Food and Drug Act.  As pras-
surs to expand the scope of that law arose ia the 1930s, however,  legislators
recognized that federal law did not protect consumers from adulterated or ais-
branded cosmetics.  Indeed, in the years just prior to the enactment of the
FDCA, consumers were flooded with deceptive advertising claims concerning
cosmetics.  This led to the inclusion of cosmetics in the Act's coverage in

Chemical Substances Coverad

    Cosaetics are defined under FDCA as:

              (1)  articles intended to be rubbed, poured, sprinked,
         or sprayed on, introduced into, or otherwise applied to the
         human body or any part thereof for cleansing, beautifying,
         promoting attractiveness, or altering the appearance, and
         (2) articles intended for use  as a component of any such
         articles; except that such term shall not include soap.75

Unlike most other products covered by the FDCA, cosmetics do not require prs-
aarketing approval before they can be sold in interstate commerce.  Instead,
if the government determines that a cosmetic contains a "poisonous or deie-
terious substance," the product will be deemed adulterated and prohibited from
interstate commerce.rj  Thus, the government may regulate toxic substances
in cosmetics, but it bears the burden of proving that a cosmetic or an ingre-
dient is unsafe.  This nay not be an extremely heavy burden, however, sinca,
in a personal injury case, one court has ruled that nail polish base coat nay
reasonably be found to contain a "deleterious substance" if the polish causes
''nuch allergic reaction .   . . particularly so where the labeling does not warn
of the possible reaction and indicate proper precautions."*1

    The F3CA specifically excludes coal-tar hair dyes which are properly
labeled from classification as poisonous or deleterious.*1  There  is also no
Delaney-type clause prohibiting the presence of any carcinogen in  a cosaetic.
    "21 USC §§ 261-262.  See generally, H.R. Rep. No. 2129,  75th Cong.,  3rd
Sess. (1933).

    TS21 USC 5 22,1'i).

    "21 USC § 361, § 321.

    11 Sober v. 3 avion. Inc. , 317 ?.2d i-7, 52 Oth Cir.  1963).

    I221 USC § 261(a).

    Because  cosmetics and their  ingredients  dc nor require premarKering .accrc-

ber*re :_:.trocu:.-_r.g -iieir prcducz ir.ro  mrersrars csnanercs.

Nc Man^£"frv Rencrring Hesuiraser-rs
    "snuf acr^rers  are not required  to  report any incident or  ccntaeinaticn
 cr^err.i.r'.g  rcxics  in cosaetits,


    For several years before the passage of the Drag Amendment of  1362,|:
legislators had been concerned about inadequancies in the laws affecting drug
safety.  Drug refonn legislation was pending before the 57th Congress when
aedical researchers traced thousands of birth defects in European  infants to
the use of the drug thalidomide by pregnant women.  That discovery helped spur
Congressional efforts to pass the pending legislation.

    The legislation addressed several weak points in the original FDCA.  ?ra-
viously, drug manufacturers ware raquirad to adequately cast the safaty of
their drugs befora they wera aarketad.  However, unless the 7DA could conclude
that a drug was unsafe six months after a drug application was submirtad, the
application was automatically approved.  Another weak point raquirad manufac-
turers to show their drug was effective only if it was used to treat lifa-
thraatening diseases or if it appeared to produce serious toxic affacts.
Finally, once a new drug was approved, manufacturers wera not requirad tc ra-
port naw information concerning adverse patient reaction ~o the drug.

    The Drug Amendments of 1962 addressed these problems by requiring manufac-
turers to prove both the safaty and efficacy of all new drugs, extending tea
FDA's application review period, and craating aandatory reporting requirements.

Chemical Substances Covered
    F^CA defines "drug" as

         (A) articles recognized in the official United States Phar-
         macopoeia, official Homoeopathic Pharmacopoeia of the
         United States, or official National Formulary, or any sup-
         plement to any of them; and (3) articles intended for use
         in the diagnosis, cure, mitigation, treatment, or preven-
         tion of disease in man or other animals; and  (C) articles
         (other than food) intended to affect the structure or any
         function of the body of man or other animals; and (D) arti-
         cles intended for use as a component of any article speci-
         fied in clauses (A), (3), or (C) of this paragraph;  but
         does not include devices or their components, parts, cr

Any drug introducad into interstate commerce is subject co the provision of
the amendments as a naw drug unlass it is:

         a.   generally racogniied as safa and affective by
              axperts,  or
    I30ct. 10, 1962, Pub. 1. No. 37-731, 75 Scat. '31-733, 73-, 73;, 796,
generally ccdifiad as 21 :JSC § 253.


                        a tre-l^ww  «ru ~ w r*i c n * z.2 s u t ^ ^ ~ *" ~~ ~ '? °
                        ?u re  Jcod  anc Drug Ac. and "-.'"nose laoel rep-
                        resentations  concerning conditions of use
                        nave  net  cnanzed. E5   -                ,,,.,-_
   s tnat •_^.._:"e previous  aaen^rer.s  Discussed,   generally recognized'' hers
   .-c.es :;ct:i safety and effectiveness.   However, throug:: these -wo excep-
   r.s, cir-.gs wiich have srocd  the  test  of time need not be subjected to  the
   li-atio^ procedures for truly new  or  less -accepted crugs .
    T~e cs^rt^ hava  interpreted  the  statutory definition of "drug" very

          ?urthfcr=cr&, the  legislative  history,  read in light of tne
          scatutfe's  raaediil purpose, directs us to read the classi-
          fication  'drug' broadly, and  to confine the device excep-
          tion as nearly as is possible to the types of items Con-
          gress suggested in the  debates.  .  . United States v. An
          Article sf Drug . .  .  3acto-L'r.idisk . * *

          ?. ir.ce -he  o-ly significance in classifying AMP's products
          ss ^it.-.s;  ' ;.rugs ' or  'aevices'  is  that if they are  'drugs'
          they say be subject to  the 'new c.rag'  provisions of the
          ict, we rust classify  then ^itr. reference to the purpose
          -or v'r.i.->  Congress enactec -.hose provisions.  That purpose
          --as. v----'  clearly, to  kaep ir.idecruately tested aecical and
          rslE.ec irocacts whirh  si^ht  cause widespread danger to
          v'-rsr, _i;«. 3 ut cf _n»;sr3tace  ccnaerse.  The product whic.2
          -.^•Ee^i.-itely precipitar.ee Congress icnal concern -- 'Elixir
          SL.lri2-.lar.ide' -- was  a dr-ig  witiia the everyday, narrow
          sense cf the word, but  we  would hardly suppose that when
          lor.grass incorporated  the  'new drug'  bills resulting fron
          -ha 'Elixir Sulf anilanioe ' tragecy into an Act which con-
          tained an  extremely broad  definition of the word 'drug' it
          intended that the operation cf those provisions should be
          :-esrt i;;ted to products  cosnor.ly called 'drugs,' and that
          prccu-ts such as  ligatures , which  might present the very
          dangers trie provision  were designed to meet, should be
          excluced.  We would, moreover,  be  reluctant to give a nar-
          row construction to this statute,  touching the public
          aaalta as  it does.  AM? , Inc .  v .  Gardner . * 7
     '21 ;:.'SC § 321 (p) .
    |r2S9 r.2d 525, 829-320  (2nd Cir.  1968),  cert,  denied, 393 U.S. 325
(1968), r?..-.. ce-iad, 395 U.S. 917  (1969).


          From  the  preceding discussion, it is clear that whenever
          chare is  a problem of construction,  the duty of the courts
          is  to liberally construe provisions  of the Act, being
          mindful of its  overriding purpose to protect the public
          health.   Meserey v.  United States."'

 In  this  last case,  the court went on to say:   "Under the Act, the safety of an
 article  is not the determining factor.   Instead, the determination under the
 Act is based upon  the article's listing in the Pharmacopoeia or its intended
 use."*5   In  short,  it natters not how dangerous something is, but only
 whether  it falls within the statutory definition of a 'drug,' as this term is
 broadly  construed.58

     It has repeatedly been held that the intended use of an article determines
 whether  it is  a 'drug'  for purposes of the F3CA.  As stated in Hans or. v.
 United States:'1

          Thus, it  is the intended use of an article which
          determines whether or not it is a 'drug,1  and even the mcst
          commonly  ingested foods and liquids  are 'drugs' within the
          meaning of the Act if their intended use falls within the
          definition of §221(s)(1)(3).

 This case and  several others12 have, under this rule, held laetrile tc be a
 drug subject to the FDCA.  Not even the use of that drug by terminally ill
 patients is  exempted.13   The reach of the definition is so far that it
 includes honey, when it is claimed to be a panacea,"1 and peppermint taa
     "447 F.  Supp.  5-3,  553 (D.C.  Nev.  1977),

     "447 F.  Supp.  at 553.

     "This broad constriction is not to be taken too far, however:  "Here
 again,  in our construction of this explicit Act, we must be sensitive to what
 Congress has  written, and recall that 'It is for us to ascertain  -- neither ~:
 add nor to subtract,  neither to delete nor to distort.'"  Fleming v. Florida
 Citrus. Exchange, 353  U.S. 153, 166 (1953), rah, denied, 353 U.S.  3-c (1559).

     ''•Citations omitted.  417 F. Supp.  30, 34 (D.C. Minn. 1967),  affirmed.
 54Q ~.2d 947  (3th Cir. 1976).  See also the cases citad there; C-a.clar v.
'U.S.,  425 ?.  Supp.  24- Q.  Mian. 1977)  and cases citad there at 246-2-7;
 National Nutritional  Foods Association v. Mathevs,  557 F. 2c 225 (2nc 2ir.
 1377)  anc cases citac thera at 223-23«-.

     51  Hanson v. United States, suora;  United States v.Articles  of Feed
 and Drug, •*—•* F. Supp. 256 (3.C. 2.D. Wise. 1373).

     13  United States  v.  Rutherford, 442 U.S. 544 (1379).

     5 u  United Statas  v.- 250 Jars .  .  .  U.S. Fmcv Pure Hcnev  213 F. Suet;.
 2'C 3 (i  2  u" ch  1362^  a~~" ~"m ec  3 -V- r ^* 2c 233 C;tz 2"~   "365N

 •. ;ve< . ..v,~r.  :.  ' e.-.-e.,  ~.c be u*ec as cruzs . ""'   1"  does  not ever; matter irc.£t
 -.•-v itt .__  -_f.i;;  cf  "he procu;;t 15..  "Regardless cf the actual physical  sf-
 .&:.i  :r tr.t ;:r?c.^c.t,  ones it is established  that  its intended use brings  it
 .•:-.in: :.ne  c™.ig ::& fir.it ion, it will be ceeaed  a drug for purposes cf the
    T";e courts  have  also adcrassec, or. numerous  occasions, the question  of  how
tiis ' u:.te:.cad  use '  is  to be aeterained.  The  -curt in United Stares v.  JLrti-
IilL_il.,iZVii_-2^.'.*T -star.ee:  "Courts have uriforsiy helc that the search
f" -.:„&   i;ts.t..ei -i.se'  cf a prscuct is not Liaitec to the label on the con-
* a ir.?.r  £nd =s^  axtenc  to oral and -rritten r ep revert at icns about the proc-
~:~.z "  ir. i-itirasting  rationale for this ~ile vas given in United Statas v.
          T;.a  real  test is hov was this product  being sold?  If as a
          food,  was  it for the famishing of  energy and body biiild-
          ~,g?   Or  was it being sold for the  treataent and mitiga-
          tion  of disease?  The answer is presented ail through the
          evidence  that treatment, cure, litigation and prevention
          cf disease was the purpose for which >iucorhicin was sold
          by the --efincants and ocught (and very frequently pre-
          s-cr;',-;ei';  by the purchasers.  No natter how loud and long
          one  ~sj declaim that black is '-a:.te, black is nevertheless
 ie rapres(tn;?:i;r.s  that may be used to determine the intended use of  an  arti-
 Le irelude  ':-s  label,  accocpanying labeling,  promotional material, advertis-
 :g, in:, ary ccher  relevant source. "'*
    Si '-'"i-ad  States  v.  Kohensee, 243 F.2d  367  (3rd Cir.  1937), cert .
de-iad, 253 U.S.  376  (IP57), reh. denied. 354 U.S.  927 (1957).
             ey  v.  United States, 447 7. Supp.  548,  553 (7J.C. Nev.  1977).

    ":£3 ?.  Supp.  212 (D.C. Nebr. 1967).

    !8:.:,7 J.  Sipp.  375,  386 (D.C. V.D. ?enn.  1964),  affirsed. 347  ?.2d  233

    'S "'i'-'-iSi. states "  Article  .  .  .  Consisting of 216 Cartoned Bottles
    .  '"utfcen ~:har.2e, " 409 F.2d  734, 729  (2nd Cir.  1969) and cases cited


    An interesting line of cases concerning creams promising  to  smooth
wrinkled skin deals with the issue of determining  -he  status  of  such  crsaas
under the ?DCA.  The first of these to be discussed here, Unitad Stares  v.
Article Consisting of 36 Boxes,  . .  .  "Line Away Temporary VrirJcls  Smoother.
Cor?,"1" found that "Lina Away Temporary Vrinkle  Smoother" was  a drug,
stating "a Court should be reluctant to give the Act a narrow construction,
touching as it does the lives and health of people who are largely  beyond
self-protection."1'1  In 1369, the next year, a similar product,  "Sudden
Change," was also found to b« a drug,  so long as it is claimed to give  a "faca
lift without surgery" and to "lift out puffs."112  The central issue  thera
was whether these claims were mera puffery which virtually everyone would
accept as such and discount appropriately.  The court  held that:

         In other words, with the exception of those claims which
         have become so ass-ociatad with the familiar exaggerations
         of cosmetics advertising that virtually everyone can be
         presumed to be capable of discounting them as puffery,  the
         question of whether a product is  'intended to affect the
         structure * * * of the body of man * * *' is  to be answered
         by considering, first, how the claim sight be understood by
         the 'ignorant, unthinking or credulous' consumer, and sec-
         ond, whether the claim as so understood may fairly be said
         to constitute a representation that the product will affect
         the structure of the body in some aedicai --  or drug-type
         fashion, i.e., in seme way other  than aerely  'altering  the

    The test enunciated in Sudden Change was utilized  two years  later in a
case dealing with "Magic Secret."'a*  The  opposite conclusion was reached
there, however, because the claims for "Magic Secret"  were less  exaggerated
than in the prior two cases just discussed.

    Just because a substance is  a drug does not aean that it  nay net  be  dis-
tributed i2. interstate commerce.  There are two aajor  exceptions, as  indicated
at the beginning of this section.  The exception which is of  greater  intarast
here is the one requiring that the drug be generally recognized  as  safe  and
        ..I'.- we "3  genera.." rsccgnizac   s.s  the™ appear ir. 21
        U.J.Z. s »21vr) srs tarrns of  art  2;;;: their ir.tarDra-3.-io"
        s.s  1:1 :ha. context of crug -sage poses  various  pr obi ens that
        have lac to tn-e ia.se Law cevelcpnent of  ::srtain objective
        indications of recognition  and non-recognition.

.is  ccur-  ir mat -ase went on to discuss  these indications:

        Ine umciition that a drug  is ^ot  gaasraliv recognized- -
        atcn.^ •V>i---if-?d experts as  safe an::  efrsctive  for its in-
        tescec use, tr.st setae Courts  aave  accepted1, is the absence
        of  a.~y sublessee aedical or scientific literature relating
        to  tss visage of the drug since the lack  of documented
        Knowledge of the drug's effectiveness  or  safety.   This test
        by itself has bean recognized  as  determinative of 'newness'
        by sav.ril cases especially  in  this  district.13*

        >:. -r .,--.-:::,: ~~zv~ sears,-,ed for  prcuf of general recognition
        -~ diirtren:, sc:it;r directions  and have required a higher
        cei:ri£- ci troof to establish ncn-recags.it ion.
        3oae cifficulty has been encountered  by the Courts in
        aeteri'-ning precisely wr.at degree  of  recognition both in
        quantity and quality constitutes  'general  recognition'
        under thi statuta and that task  is  rendered all the acre
        difficult when ir oust be accomplished within the strict
        csnf.ir.fii of the summary judgment  rule on the basis of can-
        ~"lic::_ig affidavits which ail  ciaia expertise in the
        field.  Sons »ases have taken  the  position that the aere
        existence of conflict between  qualified experts in s'upport-
        in£ affidavits establishes a lack  of  general recognition as
        d natter of law while other Ccur^s  in dicta attenpted to
        soften the mere conflict rule  where a genuine difference of
        roinicn axists since general recognition ought not mean
        iz.sniasous recognition.                              "
   :"3-5 ?. Sup?. 57'., 574  (D.C.  N.D.  111.  1972).

   :"I-  Uni_:ed States v. Article  of  Drug  .  .  .  "3entax Ulcerine", 469
.2c 375 (5th C.r. 1972), cert, denied,  412  U.S.  938 (1973), the court
:nsiders:c "alnsst non-existent"  literature  relating to the product persuasive
it not cc-ncl-isiva evidence of non-recognition,  although it, ultimately held
iat tr.e ^"jg was rc_t generally recognized  as  safe and effective.


         In addition to the various rules -hat have evolved in
         regard to the weight given affidavits in such an action
         certain guidelines developed pertaining to the qualifica-
         tions of the affiants and the content of the affidavits.
         Seme Courts have pointed out that the personal opinions of
         experts are not adequate to establish general recognition
         and that the affidavits should instead attest to the exis-
         tence of the opinion or recognition in the general commun-
         ity.  Furthermore, the affiant expert oust be one qualified
         by scientific training and experience to evaluate the
         safety and ftffactiveness of drugs and cannot simply be a
         medical practitioner whose only knowledge is based on pre-
         scribing the drug for his own patients.:J7

    Whatever test is used,

         [T|he hurdle of 'general recognition' of effectiveness
         requires at least 'substantial evidence' of effectiveness
         ...  In the absence of any evidence of adequate and veil
         controlled investigations supporting the efficacy of [the
         product], a fortiori [it] would be a 'new drug' subject to
         the provisions of the Act.la*

As stated in U.S. v. Articles of Drug Labeled Cclchicine,;3' "The critical
test is not whether the product is in fact safa,  but whether there is  general
recognition among qualified experts as to that fact."  Thus, only by  fulfill-
ing the tests mandated by the statute and the courts can a product be  found  to
be generally recognized as safa and affective.  As indicated in a law  review
article dealing with the FDCA,:ia this could lead to an anomalous result:
"[A] safe drag not generally so recognized would be a new drag, and con-
varsaly, an unsafe drug generally recognized as safa would be an old  drug.''

    Drugs can be deemed to be new drugs under the 72CA not only because they
are actually new and do aot fit under the two enumerated exceptions,  but
because they are being put to a new use or ara part of a new combination  of
drugs (even though the component parts ara all tried and tested).  For exam-
ple, a drag which is generally recognized as safa and effective  in single
    lsrCitations omitted.  345 F. Supp. at 574-575.

    13'Footnote omitted.  Weinberger v. Hynson. Vescott a Running,  -12  ",'.;.
609, 629-630 (1973).

    l"Zmphasis added.  442 F. Supp. 1236, 1242 (3.C. S.D.N'.'f.  1973).

    liJI1-rug Ifficacy and the 1367 Dr_g Amendments," 50 Gaergatovn  l.J.
*ac  'fl— ^1c — ^ ^
i2J , j.3; i, is/ .) .

~3Sd~-, ~~r~  .tas  oeer. he.c ~~ oe £ net c.rug  in  time release capsules . ' * *
Si;r,i_.irly  m  L'r.itec ?tater v.  Article of I— .15 .  .  .  "M~kocart , 'f : ~2  a  drug

genst-'i.". 1;. ic-c^r.^iec as  safe anc effective,  was  he.d  to be a sew  drug.

    As car: DS  easily seen,  the provisions of the ~DCA relating to drags  have
engercere:: a good  deal of litigation.  It may  well be asked what  purpose 5.11
cms  liriS'tion  serves.   As stated in National Nutritional Foods  Association
T_. _ ,^£L^£i} : ' " '   "The aeterziiatis- t.iet 22  article is properly regulated as
a cr~-j   r.;;w «ve r ,  is  net  left to the Cocniss '.oner ' s unbridled discretion  tc  act
to prc~ac:. ".^e p-iilic health but aust be is,  accordance with the statutory
dtf initiar;.    Tia  court  system acts as a check en the I"DA ir. carry:^:g  cut its
vital rc_;. ~.  pr:tectia.g tae public.  Perhaps  this role is best summarized  by

               7.26 nstory of the Food, Drug,  aad -osasetic Act is.
          the  courts demonstrates that there is  no shortage of
          pecd.ers who claia that their miracle  drug  must be made
          available  to the consunir.g public  without further delay.
          A  parallel history of product liability litigation also
          cere'istr ates the danger that new  drrags may  be released
          •--  - * i,.-"  , *ia^"^3*".i ~ac'**r^'^  """j^j o™*"O"'l  ^^*""*" *"T"?'^*("
          ^..  .ll«w.»  ^lk.;^.c, es .   The balance between these competing
          c-r.s .--.. a,", ions _s one which has already been struck by
          ^or.grc.js5  anc  it is cr.e wnich has  seen repeatedly upheld
          DV th-j.  courts.  Cnly recently the  Supreae Court reaffirmed
          tr.ir, judgnert  in Weinberger v. Hynson, Vescott & Dunr.ing.
          -;:.  •J.ii.'bCS,  £22, 92 S.3t. 2^69,  2479,  37  L.id.2c. 207
           ! .  .  .   Congress surely has great  Leeway in setting stas-
           :.arc.s  frr  releasing or. the public,  drugs which may well be
           r-ir-ides or,  or. the otner hind,  merely aasy money-making
           schemes  through use of fraudulent  articles labeled in mys-
           terious  scientific dress.  The  staiidards of "well-cen-
           tre lied  investigations" particularized by the regulations
           is  a  protective measure designed to ferret out those drugs
           for vh.ca  there is no affiraa-ive,  reliable evidence of
           ef f t. :t .veness .  . . . '
     :i: 'J-5-  "•  Articles of .Drug Labeled  Colchicine, 442 7. Supp.  1236
VT. ~., S.-..<  :'.  l'?~5).   See also Hoffman v.  Sterling Orug, Inc., 435  ?.2d 122
(3r- Cir.  15"3j  and citations there  at  137.

     ::z3ii T.  Sup?. 571 (D.C. N.D. 111. 1972).

     i;3S;T F.2d  125,  234-325 '(2nd Cir.  1977).   See also Weinberger v.
H^c-  Wescott  a Winning, 412 U.S.  609  (1973).

     l:"-i: ?   Supp. 30, 27-38 (D.C.  Minn.  15"6) .


Scars-pry Criteria

    Mo new drug may be introduced or delivered for introduction to  interstate
commerce unless the Secretary has approved the use of she drag.1''1  The
Secretary will cot approve a new drug application (NBA) 'unless he finds  chat
the manufacturer's application demonstrates that the drug is safe and
effective for use "under the conditions prescribed, recommended, or suggested
in the proposed labeling."11'  Approval will also be refused unless the
Secretary finds, among other requirements, that "the methods used in,  and  the
facilities and controls used for, the manufacture, processing, and  packaging
of such drug are [adequate! to preserve its identity, strength, cuality. and

    The starute sets out the evidentiary showing which oust be fulfilled for
the Secretary to be able to determine that a new drug is sufficiently  effec-
tive.  The requirement is "substantial evidence that the drug will  have  the
effect it purports or is represented to have,"1'1 where "substantial
evidence" is defined as:
    Ii521 USC § 355(a).  The Secretary approves new drugs through the  new
drug application (NLA) process  (21 C?5 314) while exemptions  from 21 USC  §
355(a) (prohibiting unapproved new drugs from  interstate commerce)  for
investigational purposes are obtained by wa of an investigational new  drug
(IND) notice (21 CFS 312).  It should also be notad that any  drug containing
insulin or antibiotics is misbranded and hence may not be introduced into
interstate commerce unless the Secretary has certified or issued a  release  fo:
the batch from which the drug comes and such certificate or release is still
in effect (although the Secretary aay exempt certain drugs containing
antibiotics from this rile).  21 CSC 331(a), 25.200, 352(1),  256,  357.  For
simplicity, the discussion in tae sain text is limitad to new drugs and does
not specifically deal with drugs containing insulin or antibiotics.

    11S21 USC § 355(d).  To gain approval for drugs regulated under the
original 1933 FT.CA, manufacturers only had to demonstrate that their new drug
was safe.  The 1962 amendments provided that drugs previously approved under
the 1938 Act would retain their approval even though they had not been demon-
s-rated as effective.  (21 'CSC § 2010, note.)  Such drugs were subject to the
other provisions of the amendments, however, and could have their approval
revoked if the FHA finds that there is a "lack of substantial evidence" that
the drug is effactive.  21 USC 355(e).  Pre-1962 drugs which  were marketed
Without an approval because they were generally recognised as safe  were also
a-xecptad from the requirements of demonstrated effectiveness.   However, if  ner.
evidence suggests that they are either unsafe or ineffective,  tne FT.A  nay
classify them as new drugs subject to all of the requirements of ether new

    Ii721 USC § 255(d).

           .*^i-_c:ce  cons istir...? or acecUi.T = sr»c i?s_--ccr.trc:-..ec inves-
           ti£3.iior..s ,  mcluc.ir:r clin.ica.1 investigations,  by experts
           rualifiec  by scientific training and experience  to evalu-
           zr. -  TCLC  effectiveness of the c.rug involved,  on the basis
           _"  >':.;r.r.  it  cc-lc fairly and. rssocr.sibl"  De  ior.cluded by
           scr,*  experts c^ar -he c—j.g will have rhe  effect  :.z pur-
           ports  sr  -s  represented to have under the  conditions  of
           use  prescribed,  recocaended, cr suggested  in the labeling
           or •:r;^csad  labeling thereof, ''*

~'ZA L'nits-c Stites  Suprsae  Ccurt has helc, that "the  reach of scientific izi-
                    under  this  section as it is '.inder the  ''generally recosjnized
                    ve"  requirement discussed above. ~ii

    -rugs beir.g tested  for  safety and effectiveness aay be  exespted by rssgula-
:i-r. rrc:: tr.e ^er.ars.1 provisions  of this aaendaent . : 2 '"

                    full  reports  of investigations which  have  been
              •.:ace  to  snow  wnetaer cr not suon crug  is  saza  for use
                                             s used as  components  of
               (3)  a  full  statement of the cotspositicn of  such drug;

               »  *  full  description of the methods used  in,  and the
               facilities  and  controls used for, the manufacture,
               processing,  and packing of such drug;

               ', 5}  such  samples of such drug and of the  articles  used
               as  components thereof as the Secretary may  require;  and

               (6)  specimens of the labeling proposed to be  used  far
    "" '**-nberger  v.  3er.tex Pharmaceuticals, Inc.. 412  U.S.  645,  653


Mandatary Resorting Requirements

    Section 305(j)123 of the FDCA authorizes  the  Secretary  to  raquira  hold-
ers of an approved drug application to "establish and  oa.iivta.iz such raccrds,
and make such reports to the Secretary" of  information he may  need  "to deter1
nine, or facilitate a determination, whether  there is  or may be ground" for
withdrawing approval for the drag because it  may  be unsafe  or  ineffective.
Siailarly, Section 50S(i)llfc permits the Secretary to  racuira  safety and
effectiveness reporting for drugs under investigation  by experts.
    l:321 USC § 255 (j).

    -1":: USC § 255(i).

    " r.e T'JZA was  primarily desijnec to  regulate  procucts intended  for. nussaii
use.  -s &  r £_!:,  ;.:: jv.ncns concerning  zr.irDal  drugs were scattered  tnrct.gh-
cur -.a- a;;-  -,:.  :oc :  ..  ^o.^rcuicitec,.  A  :.e*  -_;_:2al  drug," for instance,  could
be  rtgu..a:;ec n;- ,.-  „;&,;•; ions ccncer.i_ng  'new  drugs," "antibiotics ,"  cr "food
3.£c.iti~es. "  I: v~.o often sore ccrtplicatec  to  get a "sew aninal  drug" arorcved
tnar. to gs.in apprcval  fcr a new huaan dr-ag.   Is  responsa, Ccr.gress  passed -he
IrcS assascjse-^s  :c  ccr.sclida-e the provisions  canceming aaiaal  drugs.'2*
Elii^na-i::* ds_27s  i-  the approval of safe  and affective atinial  drugs benefits
be _r, rroc~.ic.ars s.nc  c
            few  esc -;ticn.s ,  ary ar.iaal drug  i."troduced into interstate  conaierce
            tc. tje  provisions cf z.*ie Animal  Drug Amer-daests as a new  anisal
         a.    gei-i-sllj recr:gr.izac as safe  and effective, or

         :: .    a  pre-l?23 drug v'r.,io- was  SUDJ act to the Pure Food  and
               I rug  =*t and whose label representations concerning
               cor.c.: '.'ic-s of use have net  changed. •• '

Any dninal dr-g  rreviously approved as a  "drug/' "antibiotic.," or "food addi-
ri>'e ' r'it.iir-s  i"s  spprsvai as safe hut it  is  subject to the general provisions
cf the .-juendae-'cs .   Ar.y animal drugs marketed without approval before  1S68
because ti:;ey were  generally recegsized as  safe are exesipt from the new ef::ec-
tiveness -requnesjents as long as their labeling does not change.

    Several  ;ases  dealing witr. aniaal drugs  nave held that sinilar standards
app.y to ::hese drugs as apply to non-animal  drugs.  For exact? le,  the  cou—: in
-nitec ^t.n-ii-  "   Ar*-i:.-e cr .(rue
"intrcl-C Medicated"':I7  ruled that
the sase ,;tazdard  of general reccgnition  of  safety and effectiveness  applicable
to £cr.-an:,jsal  crugs  applies to animal drugs  and that general recognition :or
the coErso:..ent  parts  of a drug supports a  contention that the drug  is  not A new
drug only  if the combination is net itself greater or newer than its  part:.
•'ac-ii the  similarity -o the discussion of nee-animal drugs &~ notes  112 -o
*--' 5"~~;.Jr•   -a acdition, the cour~t in United  States v. Articles  of  ~ocd
sjid Drug "cr.sistir.g  of Coli-Trol 80. F^-C-60  Feed Grade. £ntrol-S Medicated,
Entrol-?"'^ rel-ed on cases dealing with  noc-aniaal drugs in establishing
the levsl  of proof necessary to demonstrate  general recognition of safety and
effect iv;. isss .
     "'.Tu'.y  .2.  196S,  Pub. L. No. 90-299,  82  Stat.  243, 351, generally

Statutory Criteria and Factors far Regulation

    Any new animal drug covered by the FDCA is unsafe for distributives  u;
interstate commerce -unless the Secretary has by regulation  approved  the  use  of
the dru?.12*  Tae Secretary must find that the manufacturer's  application
demonstrates that the drug is safe and effective for use "under  the  condi".ior.s
prescribed, recommended, or suggested in the proposed labeling.""13  The
Secretary must also find, among other requirements, that "the  sethocs  used in.,
and the facilities and controls used for, the manufacture,  processing, and
packaging of such drug are [adequate] to preserve  its identity,  strength,
quality,  and purity.";3:

    When reviewing a new animal drug application "the Secretary  shall  consider,
among other relevant factors":

              (A)  the probable consumption of such drug and of  any
              substance formed in or on food because of the use  of
              such drug,

              (3) the cumulative effect on man or  animal of such
              drug, taking into account any chemically or pharmaco-
              logically related substance,

              (C) safety factors which in the opinion of experts,
              qualified by scientific training and experience  to
              evaluate the safety of such drugs, are appropriate for
              the use of animal experimentation data, and

              (D) whether the conditions of use prescribed, recom-
              mended, or suggested in the proposed labeling are  rea-
              sonably certain to be  followed in practice.i3:

    Drugs being testae for safety and effectiveness by experts say be  exempted
by regulation from the general requirements of these provisions. ::J

    In general, the Secretary may not approve the  use of a  "new  animal drug''
if it "induces cancer when ingested by man or animal."13"   However,  "if  the
Secretary finds that, 'under the conditions of use  specified in proposec
    :I321 CSC § 360b(a).

    135:i CSC § 36Gb(d).

    ; 3 '• To id.

    13:21 "JSC § 260b(d)(2).

    ::::i U3C § 26Cb(j).

    '•"3:i "3C § 36Cb(c.:. t'-XH} .

iDe.ir.g  and ra.iscr:a.-l7 certain co be followed in practice  (i;  such drug will
:t  acversc..y affect ;?.e animals for which ;,: is intended,  and  (ii) no residue
f  such  drug vi._ r.-j found .  .   . in any edible portions  of  such az.img.ls after
.au^r-ier  =r in any :ooc -gelded by or derived froc  the  living  aniaals," then
-.&  5ecra:ary i4~ azprcve tae use of a carcinogenic  animal  crug.lls
                    approval of s. new aniaieLl drug  shall  cczrair.:
             N., ;  ru.ll  records of invest iga:. icns which  have  been
             z«.de tc sac« whether or not s\iih drug  is  safe  and ef-
             fective for *jse;

             (:,)  a ful. list of the articles used as components cf
             such ™*j,g;
             ^;)  a, full stateaent of the composition  of  such drug;

             ('•)  i full description of the methods  used  in,  and the
             facilities snd controls used for,  the  manufacture,
             proce-isi^g, and packing cf such drug;
             (:!;  3.. th samples of such drag and of  the  articles used
             = :; -.ocrcnents thereof, of any aniaal  feed for use in.
             or or- which such drag is intenced,  and  of the edible
             portions or products  (before or after slaughter)  of
             animals to which such drug  (directly  or in or on  ani-
             oal  feed) is intended to be administered,  as  the  Sec-
             retary aay require;

             (6)  specimens of the  labeling proposed  to be  used for
             such drug, or in case such drug is  intended for use in
             animal feed, proposed labeling appropriate for such
             u;.e.  and specimens of the labeling  for  the drug to be
             manufactured, packed, or distributed  by the applicant;

             ('')  a description of practicable methods  for  determin-
             ing  the quantity, if  any, of such drug  in or  on food,
             and  any substance formed in or on food, because of its
               t;  and
             (S) the proposed tolerance or withdrawal  period or
             other use restrictions  for such  drug  if  any tolerance
             c- withdrawal period or other use  restrictions are
             required in order to assure  that the  proposed use of
             such drag will be safe.13'
      21 'JSC § 36Cb(b) .


Mandatary Reporting Requirements

    Section 512(1) of the FDCA137 authorises "he Secretary  to  require  ho le-
ers of an approved new animal drug application to "establish and  aair.tain  such.
records and oake such reports to che Secretary" of  inforaaticn he say  need ''to
determine or facilitate a deteraination, whether there  is or may  be  grour.cs'1
for withdrawing approval for the drug because it may be unsafe or ineffec-
tive.  Similarly, Section 512(j) of the FDCA131 permits the Secretary  to
require safety and effectiveness reporting  for new  animal drugs under  investi-
gational use by experts.
    -37:i -JSC § 26Cb(l).

    :"I1 "SC § 260b(j).

    In ac.iiticr.  to  tne  previously identified previsions concerning potentially
toxic cnemii-Lls,  tr.e  ~3Ci  regulates "poisonous or deleterious  substances" ir.
foccs ;  '?•: isorc-js cr  deleterious  substances" in packages containing foods,
-r-gi j ifcii-.al cevices,  inc.  cosaseiics;  and aedical devices.
    Senarill;-, 2  foci  is  considered "adulterated" if it contains  any poisonous
cr deleterious substance  »r.ich "aay render it injurious to health."14"
~occ,i *it:. naturally occurring toxins are not considered adulterated "if the
~u£zi°.~t"~ -,'r sucz  suostancs  in sucn zooc coes not ordinarilv  render  it in*uri*

    -»":,sn an added "poisonous  cr detericus substance" is required  in production
          oe removed  througn  good aanuracturing process,  then  the Secretary
will issue .-, regulation  setting a tolerance for the substance  "to  such extent
as r.e fines necessary  for  the protection of public health."''*1

?cisc:.cus rr Isleteric'—s Packaging'k 3

    Any  :::oc,  crug,  aedical  device,  cr cossetic is considered  "adulterated" if
its container  is  ''conposec.,  in wncle  or in part, of any poisonous  or deleteri-
cu.s subsr.utce  "»r..lr,"  aav  render tne contents injurious to health."1*"  ~ood*
pacjngir.5 materials  aay  be considered food additives as discussed  above ia the
text accc-^t.ar.'-'ir.s notes  55 to 59.
    Under the r_.C&,  the  ters "device" is generally defined  as:
         ;iace,  : replant,  in vitro reagent, or other similar  or  rela-
         -;ec  article,  including any component, part, or  accessory,
         which  :.s~-
     ::s:i USC  §?  3^2(3.;  and

     -4021 USC  §  342(3).
     :"::i USC  §  3-6.

     Ik3:i USC  §§ 3-:(a),  351(a), and-361(d)

     • * *  "* V -' ^

     ;"5I1 USC  I  360c et seq.


                   (1)  recognised in the official National Formu-
              lary, or the United States Pharmacopeia, or any sup-
              plement to them,
                   (2)  intended for use in the diagnosis cf disease
              or other conditions, or in the cura, aitigation,
              treatment, or prevention of disease, in nan or other
              animals, or
                   (3)  intended to affect the structure or any
              function of the body of man or other animals, and

         which does not achieve any of its principal intended pur-
         poses through chemical action within or on the body of man
         or other animals and which is not dependant upon being
         metabolized  for the achievement of any of its principal
         intended purposes.1*8

This is a much broader definition than had been in effect before the Medical
Devices Amendment cf  1976. l*T  The purpose of that Amendment was to affect
the regulation of medical devices, not really to altar the regulation of toxic
chemicals.1"1  However, such chemicals nay be affected by the regulation of
devices since they may be a "component'1 of devices.  The aedical devices pro-
visions of FuCA permit the Secretary to ban the use of any aedical device
which presents "substantial deception or an unreasonable and substantial risk.
of illness or injury."1*'  In addition, he aay control the use cf dangerous
chemicals as components or ingredients of a Class III medical dex-ice (Class
III devices require premarket approval), if the substanca makes the device

    "Medical device"  provisions, like these for "new drugs" and "new animal
drugs", require the holder of an approved application or investigaticnal ex-
emption to make reports of any information the Secretary may need to assure
the safetv and effectiveness of the device.1S:
    Ikl21 USC § 321(h).  Familiar examples cf devices are such things  as
pacemakers, X-ray machines, and I'JDs.

    1<>7May 23, 1976, ?ub. L. No. 94-293, 90 Stat. 375.

    ;i"The legislative history of the Medical Devices Amendment of  1976 is
found in S. Rep. No. 94-33, 94th Cong., 2nd Sess., reprinted in U.S. Cede
Cong.  and Ad.  N°ws  1070  (1976).

    :*'21 CSC 3 360f.

    "SJ21 CSC § 360e.  Control of such chemicals  as components or ingredi-
ents of a device is also possible under 21 CSC §  260d, authorising  the Secre-
tary to promulgate  regulations for Class II devices, which are subject to per-
formance standards.
     : s i
       21 CSC I 260i.

                          DCZ . DRUG .  ANT)
     ,2e Feed. Drug, and Cosmetic  Act  (7DCA)  is  the major statute grafting
a,:"_crit*-"  :=r t:ie :: pi rations cf  the  ~ooc  and  Drug Administration (FDA).  The
A~r gives "-lift "HA bread power  to ensure that  f ocas , crugs ,  medical devices
arc cosa&tics distributed  in interstate commerce are safe for use by consumers.

     In j-ereral. any product covered by the FDCA which is unsafe or contains
an unsafe  :.he-r.ical component is  considered "adulterated" and prohibited  from
distr _buti.;r. cr sale.  To  protect  against unknown risks, the statute also pro-
hibits manufacturers from  using  or distributing  a "food additive," "color
additive," "pesticide chemical used  in or on  raw agricultural comnodities , "
''new crug,"' "new aniaal drug"  or "nedical device" 'unless it use has b-een
cipprovec z- tne Secretary  (see note  115  in the Statutory. Review) .  Exhibit 3-i
! ists "he  regulated substances ar.d summarizes for each:
     "    :.he  ~Tptt cf  regulation  authorized,

     •    the  cr-.tsria  for  the  standard,

          :.r.e  basis  for  setting standards,

     *    :,,,;e  -pa~~'f  with the  burden of proof,  and

     *    whether a  risk/benefit  analysis  is  required for regulation.

     As aas'inced, the FTCA  is  quite  comprehensive ;  over 3000 pages cf  regula-
tions mte:~r*t and  inplenent the Act.   ?or the most part, these regulations
closely follow thsi provisions of  the statute.   The following sections  explore
the regulations as they  concern the various categories of chemical substances
governed sy- t.ie Act:

     *    Pesticide  Residues  en Food                 40 CTR 180

     •    Unavcicable  Poisonous cr                    21 CTS 109
            deleterious  Substances

          l-"ood Acditives                             21 C?R 193

          Color Additives                             21 CTR 70

          New  Drags                                   21 CTS. 300-460
                                                        (Sub-part D)

     *    Sew  Animal Drugs                            21 CFR 556

          Ccsaetics                                   21 C?H 700

          '^ecical Devices                             21 CT3. 860

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                                                         '52   M
                             ~±— "**a 3 ** •* — *• C. *•" £1 C** '  3 ™ • ^V^ ^  • * * —  .. — — v.*
                             VM ..... — c ~»*w -*- 1. . " ^ w— w. » ... wi.3 ,     a  * *~ ^ — .*.
chenical  is sry  substance vr.ich,  alone or ir. ccnbinaticr. with other
suostarces  ii a  'pesticide" as defined by the Federal  Insecticide, Fungicide,
~ ~ d \wC£~™ c " ~e. -c1-  1'™ ""^Lr1 )  •' - 2 C^*""* § 1 5C . '  ' '•" ^ V|
                                                     h  bears sr ccn^air.s  a
~3T ci r..ie I?A  ~.3^s  se.  i "olerar.ce ^i-a- aax^aur:  permissible concanzra'icn.)
rr-r t^e c~!u2^c;l  en the ccaaodity '21 "JSw §3»6a) .   Before the Accmistrator
cir. sat su::c a  tcler?-ace,  rswever, tne "pestic^da"  coct.air.in.g the "pesticide
     -riles:. tr.e  r sgulatisr. fixing the concentration  specifies otherwise,  tr.s
  lowcble : clarences  aoplv only to residues resulting from pre-harvest  appli-
  ticn cf tne rp.st-.cice  (»C C??. liSC.l^i);.  Residues resulting frci post-
  rvest ar;::licjt : -:.  of  a cr.es.ical are typically-  controlled by a food adcitive
  •-.: l.rr ; ;r, at T"  IT?  3152.   (Mosr frerucctly, postharvest residues result  froa
  e '--3e rf p&i ; i; _..es  _,~ s:.jTi,je a;d procisring  areas cr en the outside of
 ._. •'. focc pacii^sj    Tr.es e reruldt . ens , and those  generally concerning  pesti-
 :.:.•-• •.rt-i-;al.: c:  rrr.cessec foods ; • a d:scuss".d  larer in the resort under  "cod
     Approximately  270  pesticides or pesticide  groups  have been approved  for
use en raw agricultural commodities.   They  are  listed,  along with their masi-
=ur permissible  concentrations on specific  crops,  at 40 CTR §180.101  through
150.279.  Exhibit 2-5  contains an alphabetical  listing of pesticides  with ap-
proved tcl irances,.

     Twc c. it * genes  of  pesticide chesicals  m£y  be  used on foods without a
regulatory residue  tolerance navir.g been set--pesticide chemicals which are
generally  recognized as safe (GRAS^ and tnosc which have been specifically
exesptac froa  a  tolerance by the acsmistrator.  Regulations currently  list 15
substances as  CS^S  and  note that as a general rule, pesticide chesiicals not
tontair.ec  »r. the list  are not 3RAS C-3 ^^R  180.2).
      •slAlacst  a..l  of the regulations  implementing the ?DCA are promulgated
by the "A.   However, all of the powers granted to the FDA to establish tcler-
ar.cas for  ies-,.c.ids chftsiicals were transferred  to the EPA by Seorgaaizaricc
?:.ir:  ^c.  "  of  •" "C .   23 F" 15623 October  6,  1970.


     The second category of pesticide chemicals which do not  require  toler-
ances are -hose specifically exempted according to 21 USC  §2-6a(c).   That  pro-
vision allows the Secretary (Administrator) to grant an exemption  wr.en  a
tolerance "is .not necessary to protect the public health."  Pursuant  to tnat
rule, over 600 •'3 !1 inert chemicals" listed is. *0 CFR 130.1001(c) car.  oe
applied to growing crops or to raw agricultural commodities aftar  harvest;
those listed ia 130.100i(d) may only be applied to growing crops;  and those  IT.
130.1001(e) may be applied to animals.  In addition, the regulations  list
approximately 70 active pesticide chemicals which are exempt  from  the toler-
ance requirement (40 CFR 130.1001 through 130.1045).

     All of the pesticide chemicals which have been exempted  aust  be  applied
"in accordance with good agricultural practice."  In ct.ier words,  they  -ust  be
applied by aethods and ia amounts commonly used when the exemption was  granted.

Designation Criteria

     The regulations do not expand on the statutory safety standard that sust
be met when a tolerance is set for a pesticide chemical.   The statute mandates
that the Secretary (Administrator) should set tolerances "to  the extant neces-
sary to protect the public health."  (21 USC §346a(b)).

     In prescribing the maximum allowable concentration of a  chemical en a raw
agricultural commodity, F3A nust broadly consider the risks and the oenefits
of that chemical.  The FDCA specifically states that F3A should consicar the
usefulness of the chemical and the necessity of the chemical  for the  produc-
tion of an "adequate, wholesome, and economic food supply."   Other ways in
which the consumer may be affected by the same chemical or by relatad substan-
ces that are poisonous or deleterious aust (21 CSC §346a(b))  also  be  consid-
ered.  Regulations implementing this last consideration stipulate  that  LT.
addition to considering the amount of residue which a person  may consume di-
rectly through the raw agriculatural products in his diet, consideration is
always given to residues which aay be consumed indirectly  by  ingestion  of
milk, eggs, meat, and poultry derived from animals fad the raw agricultural
products (40 CFR 130.6).

     In following these statutory and regulatory directions,  the Administra-
tor's decision concerning tolerancas for "pesticide chemicals in or en  raw
agricultural products" is acre broadly based "an other safety decisions .-can-
dated by the F2CA.  For these substances, the Administrator considers t.-a
economic, social, ar.d environmental costs and benefits of  using a
pesticide.1"  Most otnar safety decisions under the 73CA  involve  only
health considerations.
      l!:Some substances say have been  counted  tvica.   Pesticide  chemicals
appearing  in -G CFR  130.1CClCc) or  (d) say  also  be  listed  in  13C. ICCKe)

      l!"Cooper, "The Role of Regulatory Agencies  in Risk-sens:it  decision

     At ';i~e;  ::..:e Secretary aav  have  tc  o;escribe a cero tolerance  level
       :.;: rajir.y.e  ;f  -he pesticiae  cnemieal)  to ensure chat trie treated
      .a"  a sere -;?ve_ or  :ae pesticide  checica. ^n rhe d^ez of rwo
          d^ifs,rsn~ species or wara-blood.ee  an.imals has set; been
          reli£.ciy derersined,  [or]

      r=;  -he c,ht..-.^C;,l is  care^ioger.ic cr  has  crier alaraii^g physi-
          clcg.i-'l effects on "esr  animals fed The subsranca.

      7.ie saae secz-cr. allsws  -he  Secretary to  set a zers tslarance vhare  accep-
ted industry practice el^r^nates  all  residue of the checical.  He may set such
i level :.f  ,,-0 Ci'S ISO.5):

      ;c)  the thesical is  toxic but  it is  r.oraally applied at a time
          or ir. a aattsr that raw agricultural commodities will not
          -crsally bear residues,  [or]

      fd)  all residue of the  chemical is normally retocved through
          ,:ooc agricultural practice  such  as washing or brashing cr
          through weathering  or other changes  in the chemical
          itself, prior to introduction of the raw cctsaiodity into

     ?in.;lly, in considering whether  a raw agricultural cocaodity bears ;m
unsafe  concentration of pesticide residues,  "chemicals that  cause related
pharrsacolog.cal efrects will  be regarded,  i.r. the absence of  evidence to "he
contrary, as haviag additive  deleterious action."  (40 CTS. ISO.3).  As an
example. the regulations state  that  all chlorinated organic  pesticides are
consider'?;:  to h?,ve related pharmacological effects.

      Generally, if an agricultural  commodity contains pesticide chemicals with
related paarsaiclogical effects,  and  analytical methods do not permit a pre-
cise  quantitative extermination of  the amount  of each chemical present, then
the tota. residue from the related  pesticides  cannot exceed  the lowest toler-
ance  set for *.ny individual pesticide in that  group.  However, when iden::ifi-
cat_on  mfftr.cas car, prscisely  determine the amount of each chemical present,
then  a  mathematical rule is followed.  The actual concentration of each chemi-
cal is  divided oy the maximum permissible  concentration, and the results  are
sunned  fcr  each chemical.  That sum cannot exceed one.
                                actua. concentration
                             oerzissible concentration
A small :ri£ber  ~,f  exceptions  to the general rule have been issued  for  spsici:
cnemicals vitr,  added  deleterious effects.   They are listed at 40 C73 180.3(:

                              3-51                    .	
                                                        Reproduced  from     ^
                                                        best available  copy.
                              EXHIBIT  3-5
                                                                      , .-
                                                                      ' '""' "
                              AND ™1MOI-ECJLAA CYCJC ANHYDROSCLHDE5

 AMMONIUM Sl^.FAMAT2 ,.......'.'..'. [[[ lln'~tl
 AQUEOUS EXTRACT OF SEA W«D .          ......................................... lin''"-
                                  "              ....... '
 S-SENZYlABENtNE ...........              ........................................  .n'i-T
 SIFHNOX ......................     [[[ J~-:;f
 BIPHENYL. ......................... """""""'.'.'.'.'.'.'.'. .................................. i^r:.
 u:-3is(p<3ii.oRopHs.NYL).i^;.-nucHLOROErrfANCL ..... i. !!!!!!;;;;;;;"!;!!"';";"' ,w;«i
 8ORQN .......... . .....                                              •--•   .ij-
 3ROMACL ................... [[[  !;-;•
                                ................................................ ''vi'-'~
 Wwr.3UTYL-2-CHLOROPKE.NYl. -.fETHn.' METHYLPHCSPHORAMlbAVs ..................  ' 3o':9<
 CAPTAN ............           .................................
 CARBARYL ................                                                 ;'"'
 CARBCFCRAN    ..         [[[ 50-!'9
 CARBON oioxice  .....       .................................................  30-'i
 CAR3OPHENOTH10N ...........  [[[ 30.^9
 CAR8OX1N ............         [[[  'SO.. .16
 CHLORBENSIDE ........ [[[  :SO.:OI
 CHLCR3ROMURON .....     [[[  !30..a»

                                   " A :=                                     NUM8EX'

IH- ORCX'JRC "i  [[[ J80JI16
.:--'Loa"YR.rcs [[[ iso.w:
c.?r     [[[ ;so.!8i
                                                    ............................ 180.119
                                                 i"HYL~iHY;.; 3EN3NS  *C3-
     xs;iDi.i5 :N  CORN FCRACE. CORN  ^CDOES., COR.N sn^cs,  CORN STOVES..  ,»>JD
                         STt [[[ 180.U7»
                         -O^TOSpRODVCTSiN MI1K  ............................  ISO.ii'b
                                                                             iio.: is
.. CIC.-.LOR; i--e:i^>-r:'HV.?tie.vi"., ETHANE ........................................ iso.139
:.-;•!.-;.-,'. or r-  v-.HL.jRj/N'.c^c-i-TiiA^NE ....................................... iso.us
                                                              E ................ 1SOJ80
l..'-D!CHL-ROv;,NY'_ 31METHYU PHOS'r'HATZ .......................... ~... ____ ................. - ............. 180.^35
- ;LCCOP ••'. iTHY'. .............. . ____ ........................... _ ........ - .......... _ .................................... I80J8J
C.iiLiRIN [[[  180.13"
  .».N^'~OKYCr,'. ANAi.CC .................................................. 180.308
v .,- ;T'i-:> ..  - .'!^>:TXG-*-TRir,LDROMETHrL»-/7i-?H£Ni'l^.N"EOUMlNE ............. ISO-ir
C.C-Dii.Ti<:l.-i ;-,rr:-.YLr-!IC)ETHYl.;PHCSPHORCOrTKIOATE ........................ 180.J83
                          >-Mr:HY.— »YR:M:DINY'_) PKOSPHOROTHIOATE ......... iso.i53
                           nN YL^PHEN Y^; PHOSPHORCTHICATE ................... ISO-MJ
C!:"=^;uc^-^:  [[[  iso.369
D:!-JC:(vBEs~ENE ...................................... . .......................... 180J77
  5LL.-ONA,Mia= ................................. , ..................................... ISO-4!
DI^E-HOATH INC. JDINC ~3 OXYGEN ^NALOC   ........................................ i8o.i&»
  "SCXYCI:  ANALOG [[[ 180.133
!J.C!MTr:iY;-J-»'VIETHYLTHIOlPHENY!. METHYLCARSAMATi:  ......................... ISOJS)
                                       3 <4H)-VL.'.IETHVL)  PHOSPHORODtTHlOAT^ 180.134
                                       3 (4HVYLMSTHYL)  PHCSPHOROOrTHIOATE
  •nN'2'CR :~ VST A8CUTE3 IN MILK ............................................... I80.15*a
N  - DI,-;r7H't"_.':Ft"R!2!NlL'V. CHLOR.'DE  ..................................... 180.38-i
01WETKVL .->• CSPrtATE OF 3-HYDRCXY-N, N-DIMETHYL-cu-CHOTCNAMtDE ............... 180.^99
EIMETH YL ?u OS^KAra OF 3.HYDROXY-,s.METHYL-cij-CROTONAMlDE ................... ISOJW
Dl.METV'Y'. si-CS^KATE Of a -METH YLScN'ZYL J-HYDROXY-tfu-CROTONAT^. ............ . 180.^0
O.<- SiMSTH V 1. =hOS? HORAWIDOTHiOATE .............................................. , . 180.3 15
atV.ETh" I TcTR-CHUOROTEREPHTHALATc ............................................ ISO. 185
DIN S~f'-'. .i_:.:-'RJC'-.LORO-l-HYSRO'L) PHOSPHONA72 ........................ 180.198
;.;.. ^Ai  "'HT'..-" R:::'r-.JY:_SlCSPHCL!"' "      ................ . ..................... 180.372
                                                                  .................. 180.365

                                3-53 '
                             SXHI3IT 3-5


                                  NAME                                  NUMBER

SNORIN	 '30.131
BPS	 180.119
ETHEPHON 	 180.300
STHIOLATE	 180.343
ETH1ON	~	-	—	 130. :T3
5THOFUMESATE	_.....„.„	...........	_	_	-	 180.3*5
STHOPROP		_«..__	............		 ISO.iS:
ETHOXYQLIN 	-	„	 180.173

FERBAM	 180.11 *
FOLPET 	 180.191

GLYPHOSINE	 180.3 !•»
HEXAZ1NCNE 	180.:%
  MIDE	 i8Q.::s

LINOA.SE	 '	 !SO.:33
LINURON  	.'	 [80.13J
MALATHION  	 180.111
MANES	 :80.;;o
METHANE.-I.SSONIC-«.c:o	  iso"I*9
vtETriAZCLE 	  '..'.'.'..'.'..'. :io~:~:~
METT-ilDATHiON	                    'SC "-S
METHOMYL   	   	 'So"'-
MET>OPR£>E   	'  '.'''." '  '.' '.to~'9

                             .uec ;
MA7S ir.a '"-':-tTHY1_?ROPYL.JPH=NYL
-..--_•• _..c"t -" "-"scxv-xc^-'c *'•:; 	
" =:-^IV "-~~'^-S^?fa^xi— -:^BC~^NO«.~ airms .NDMWISOMERS" '
- -- - -• ---.c D-- '-?>3LiNC\A~'v-;-CNE
- "." " ,. !.-:-•:*•'-,:'.. .l~'-"-*»~HYL AV.'NCI °HOS,°H1NCTM1OY'_:OXY)
«....:--v. »vRROU2CN£ 	 	 	
vi'S "X^ Gi'
SA,. -2
i- ,/,?t.— iA;_£NE«C~ AMIDE 	 	 	
- *, „. 2-"--:.^ T\TE ^ - ' 'C AC'D
:> x -,.--." -icx'r *".,"..:. *c:2 	
'"''"' >r • , ,, ..-,.., 	

'^ , 	 ....
~;-:. "r-^f :-3cx-o£ 	
OX -:.TA- 0> 	
1- 1 . . V'
" .X ' " '~ :, ^ 'r- C^INE . ... - . 	
• »;. ,'. -.:C"- cs ;~ ':£THY', HOMOLCC 	
:.-• - ^r'- "R^NHROEHNZiNT 	
,-r.--- "^Nc
;;?. =~-.,r,-~.
: - -_i- -,f ., „•..
-j!'\-ii^,"> r — ^ *'OD""'t"V ""
-P--;- .-r
•--!C .ALONt 	
" ' " ~'%~*>-"
* t>"^'^.vv1 ^' ""Jv*^£
* - ~ c^ i j AAe""NiT~
$-?' jPv' "If1*'"1? " *"HIOCARBAMATE
-' \~ z " * 	 	 	 - 	
'--__• '•'__-•• s'- 	
----=. A_^ 	
^Vi'-'st.- 	 ' ' '
;t_; •- S1 ?'ME7HY,3iTHIOCAilBAMA7E 	
5^.?,', •,' .. i. " ''F - C F' L'Ol'.F'- x 	
'cr> LV -RU v.DJCAcr-r^T^ 	
;;.;,. -T ,;\C' . 	
c .-•--,-•,£ ,.- ,' onoP4E'-.Y BHcN'Y!. 5l.LrONEl 	
"s,^ i- : v ,- ^— . "-
" "Z r ~* r± D D 0 1
- - - > - ., ' ^ - n.
~T- ^ "
""•-•' ^ - ' ;
-5 ; , •-, v ' • - s -
~- .' ; ;-s 	 	
.... 180.338
. . ,» ;r
1 80 36S

130 :'s

. 180.260
	 180 J«
'80 "03

.... 180.291
180 P9
. . . 180.243

180 123
, 180.196
	 180.! 12
	 180. Iff?

                             2XSI3IT  3-3

                   WITH ESTABLISHED  TCLE3ANC23  (Cor.-^r.usc)


TiTilADlFON [[[  ISO.iTi
TETTlAETHYt. PYRCPHOSPHATa ..................................................  :M.J*7
                                                            !lAZONc .     'SO :95
rrfU3ENOA20L£ [[[  1SO.:«
iHTHIOCfANOMETHYUTHIOlBENZOTHlAJOLE .......................................   iSO.iSS
TH1RAM [[[  '.M.131
TOXAPHHNH [[[  :30.:33
TS1BU7YL PHOSPHOROTSiTHlOrTi ................................................  '.SO.IU
3-:.j.j-TXiC-!LOROALJ.i'I.DIlSOPROPr'-~riICCAaaAMA7E ............................  IJO.jU
•nUCKLOROBENZYLCHLORIOE ....................................... . .................  ISO.;"
U,4-TiUCHLOROPHENYLACSTTC ACO  .............................................   ISO.ZSj
TRIFORINS ........................................ ~ [[[  !30 JS:
TXIfLURAUN [[[ 30.1^

     .-__t::-,..;;:    -   ---i .-_.>,,-.. trcni-itec  tae;  us a  of poisonous cr deleterious
substances  ir  tosd.  it contained nc prevision  requiring prsaariceting approval
f-rr fscd additives.   As a result, food  processors could prepare  food with
eniitiv*:  t~at  ::,r  ir: been tested for  safety.   The federal government  could
;:.'••• :-»-• ;-ti-r.;  .,ier. i: ceuld trcve that  trie  added substance was  poisioncus
z~ ^s.it;>r• C-.A    I:;  lc"-'2, tne Food additive Amendment reversed the  required
buriir. •_,: rr:c:;  it  provided that no processor  could use a food  additive un-
less -=. -..t-l-  trcve  t.-£t t.-.s susstance  vas  safe.   Today, any aacitive th.it has
net ^eer. approvec  as  safs is automatically  considered unsafe and banned from

     .".silacting  the  strength cf the food  additive amendment, regulations iin-
pleDer.*:i.-g  21  "JSC  §r'»o, the original FUCA provision dealing vith pcisonciis cr
:<2 letari: _•;  food  additives, specify that  such  substances will gensraily be
csr.trs^l2:c  r-y  -.-.*  riewtr feed additives  amendment  (21 CTs. 109.6).  ,?or in-
stance, ::  --,,  ~.~r. t-'.-.tratior of a substance  is  safe for ingastion, then  L" can-
.-ct ?e ; = g-:«itj.  i_  _r. a;prcved focc additive.   However, i:: the  substance is
un=.vcida: ly  prsst,-:  ir. rtcds because cf wide-spread environmental cont.ais;j.a-
tir-, t:.~ rJ«  Mil  -••ant :o regulate the foods  containing the substance.   Since
t::e fscc aud-.ti'-'et  :-stjndrenr canrot be  used,  the  FDA will control the substan-
ces thro'igr.  .olei-i/ces or action levels issued  under 21 CSC §3<*6.
     . ne .-,A  -lay  :st;ue a tolerance permitting tne presence cr a  poiscnou:; c
      ~i:,'.^ sub«t'.»anc2 ;'21 7??. 109 -i': when.
                          iemior. 2e avcicec  c/  good aanuracturing
           "Tie  ".olftrarce established  is  sufficient fcr the protec-
           - ,-r.  ;,f  ".he p-.'blic v\&.alth,  taking  into account the extent
           ~.£_iji;-"'" ~ae orese"ce cf the substance cannot be avoiaed
           and  tr;e  stner ways in wtidh the  consumer may be affected
           ry tn&  saae 3r related poisonous or  deleterious substan-
           cfes,'1 Cesphasis added) and,

           "Sc  teciinclegical or other  changes  are forseeabls in  the
           r,€,.ir  ruture that zight affect  the  appropriateness of  the
           ;,:ler&J2ce established."

          ".=.•. *.%;;  :.::nditio:is are net bv-t  forseeable technological  changes nay
          r  lerfe'  of tha appropriate tolerance,  then the prerequisites  for
          •5 i  t-lars,u & have not been met.   Instead, the agency nay  set tin
          'i.ct_-,-:  level. '  The ''act_on level'1  represents the point at which the
          :  cc-.-e»  as-air.it feeds ccntaining  unavoidable contaminants.   If a


formal tolerance for an added poisonous or deleterious substance has  not been
issued, any presence of the suhstance--even if it is an unavoidable substance--
violates the' provisions of the FDCA (21 USC §342(a)(C)).  Section  336,
however, allows the agency to refrain from prosecuting minor violations.
     Action levels do not carry the same legal force as formal reguatory  tol-
erances.  Any food which contains residues above the appropriate tolerance
level ara automatically considered adulterated and barred from interstate com-
merce.  The FDA only has to demonstrate that the tolerance has been exceeded.
When proceeding against a food with residues that ara higher than  an  action
level, however, the FDA must defend its action level in court.

     The FDA also uses action levels to protect against residues of pesticide
chemicals not covered by an EPA tolerance.  The EPA could actually set  toler-
ance levels for unavoidable residues of pesticide chemicals under  21  USC  §3^6,
but they have act exercised that authority.  Instead, if the pesticide  chemi-
cal has not been regulated under the pesticide chemical amendment  (pesticide
chemicals in or on raw agricultural commodities) or under the food additive
amendment (pesticide chemicals on processed foods), the FDA sets an acticn
level.  Such a situation occurs when the EPA withdraws the registration of a
pesticide, but its widespread use in the past and a slow rate of decomposition
asean that residues are unavoidably present in foods.

     The safety standard used to regulate unavoidable poisionous or deleten-
ous substances is not as strict as the standard used to regulate other  food
additives.  In addition to considering the public health, the FTA must  con-
sider "the extent to which the presence of the substance cannot be avoided."
(21 USC §346; 21 CFR 109.6)

     Lars;.-*'  r^testing the statutory cefinition,  regulations  identifv ''food
eoc,iriva£  as   2,1  sucstar.ces. . . -he intenc.ec use  of wr.ich results  or a ay rea-
scr.aolv b- -."teotrd "c result,  directlv  or  indirectlv, either  in tneir beccE-
ir_~ i co-r: c Tier. ~  zi  food or ctaervise affecting the characteristic  of food'1 (2'.
Cr?. ."C.l     The  regulations ccntir.ue by emphasizing the broad sweep of the
cirur-i-:.o/ .   -ever,  substances used in packages  and containers  are food add.L-
~ ivsri i.^  .,,^1^^ x^.j^r^.»^ i* •. £: * * tros t^*e pac^^A^-ng to tz^e rocc,-   .«any snostwices
are speci:,-c.5,11"  c-x-.1 luc.ec from t.ie definition  however.  Substances which -ire
'e'".:.^::.',',_' r'itc~.:..:£"  a:; safe (C-RAS"!., "pesticide checicals usad ir.  or on r;iw
;,^ricul~."::s...  c^taccities'' or used in ths production, storage  or transport.iticr
   rav  agricultural products, 'color additives",  "new animal  drugs," and :>ub-
        ="trcr,'S;C  Jcr  use before 1953 ur.der  the FDCA or under  the Meat and
     r«3 *-v  -.'*  in'-  *^  ^t ~,*zz cn'?.»iMci^ suostances  covered oy tne j^ct,  no r
~-,*-~ :,.-,'•   »* ..sec -n  j*cd unless a regulation nas been pronulgated by the 7DA
 •.-^•;- ;et.; n-r-K;  ccrc'.it.oas of use for the  substance.  In general,  these regu-
.atirr.s a,e issued in response to a request  by a petitioner who  wishes to use
t.~e ac.dit:vB.    Ir.  subcittir.g uis application the applicant crust  provide i:ifor-
L:ST:C^ wh:or.  a^cr.g other tr:jigs proves  that  the food additive will be safu.
Vhe oet, t •.on'vr  i££S  net have to prove that the adcitive will be  safe unde::
all oirt'i:.".s t inc.es.   In fac:, the regulations state, "It is  impossible ir> the
prsser." s.ats »f scientific knowledge to  establish with complete certainty the
abscluta  -..arzilessness of tae use of any substance." (21 CTR l"0.3(i)).
l.-^:%ac.,  a petitioner aust demonstrate  taat  "there is a reasonable certainty
in t.ie a^-.ii  of  os ape tent scientists that  the substance is not harzful under
a-     «.    _,».a    ."      w     lf
"n —  ^nt^tt.^ec  icndtions or use.

     In rsviewi.-g safety cata sx.bcitte

     Safety "actor.  When setting a tolerance  (i.e. maximum permissible  con-
centration) for the prasanca of 3. food additive in a  food, the FDCA  directs
the FDA to consider safety factors used to extrapolate  from animal experimen-
tation data to safe human consumption levels  (21 USC  §3-3(c)(5)(C)) .   Regula-
tions stipulate that the safety factor used is 100 to 1  (21 CTR  170.22).   In
other words, the maximum concentration of an  additive in  a food  -Trust be  one
percent or lass of the amount which produces  no harsi  in  animals  during long-
tara toxicological investigations.  The 100 to 1 safety  factor say be modified
only if the petitioner demonstrates that another safety  factor  is  appropri-
ate.  (This factor is inapplicable to cacinogenic  food  additives.  The Delaney
clause prohibits any concentration of a carcinogenic  food additive  (21 USC

     The decision to approve a food additive  is thus  based on safety sens it-
erations.  The 7DA does not balance the economic benefits of the additive
against its safety risks.

     The focus on safety resulted from a Congressional  desirs to limit F-A 3
interference with the food market.  Congress  did not  want to prevent a safe
additive from gaining access to the market because the  FDA dcusted  its utility
or because its benefits were already available from another additive.   In-
stead, all safe substances would be approved  and the  market would weigh  the
value of additives with similar effects.155

     Regulations governing the use of food additives  and  setting maximum con-
centrations for their presence in foods span  almost 200  pages in 21  CFR  172-
178.  3y statute (21 USC §343(c)), these regulations  also include the follow-
ing conditions:
      (1)  .restricting the additive to use  en  certain foods,

      (2)  specifying levels of purity for  the additive,

      (3)  specifying the manner  in which the  additive can be
          applied, and

      (i.)  mandating directions,  labeling,  or  packaging requirements
          necessary to  insure the safe  use of the  additive.

      Once a  tolerance has been sat,  any feed  which containes  a greatar concen-
tration of the  additive is  automatically considered "adulterated"  and prohibi-
ted  from interstate cotnmerce.

Additive Toxic  Effects.  As witn pesticide chemicals,  whenever two rr ^cra
fooc  acditives  tnat causa similar or related  paarmacological  ccnsequencas  3.: =

r™  I"!  .~    iTr.ere t;i<= -_n;iiv:c.uiCos:r.i^ rd as s?.fe   Setmd, for  subst3j;cas used, in  foods Before 195S, t;ie
~sar tne ~, :c, .-tc'i ;-"i  cicer^e.it was passed, experts  aiay generally rscojjnize
a a'.;bs*£;- c:  . ^  .-•,*'«  :,,-.'•.:,.--. ' e.xpfl r- enc« '.3.SFd or, [its]  coziscn use in  food."
Ac.c-;;r,i:-..,  -.-;  rh.-  ~'A. *b-3:i sr.ie;r;..:,c procsdure  is used to show that  a sub-
stance  i..-  !?„•*;.  tr.e  "quantity  and quality" of the evidence must be equal to
t.-.e s" dr.c s?'.-.s r2t;u;;*3d co p.~ave  -;:ie  safety cf a  food additive.15'  The cLas-
sif i"ti.:n of s. substance as SRAS based or. its scmcicn  safe use in food p:rior
to 1?5J  .:..oes  nac.  require the same .evel of evidence.157

     Tr.e  jRAS avcectior. to tne defmiton cf food additive was designed t:s
2vc_; -c-'.,-_iv? =3.: i,-;;-:-:urers of sucstances which were already recognised  ds
safe fro::  hs.-ing  t.'  suozit to  i'orsal regulatory procedures.  In addition, it
was ccr.s :. zer^d wasteful to require expensive safety  investigations for sub-
stances  vr.ose safety had already  been desonstrated through comncn use in foods.

     "Juf srtunateiy ,  in the initial years after the passage if the Food Addi-
tive Aiaer.daent.  zany checicals were  added to the developing list of GRAS addi-
tives C-"..  «-~"^ 17C.wQ(e)') vithout  an  adequate review  of their safety.   As the
use of  additives  in  processed  foods  grew tremendously throughout the  196(3 ' s ,
several  3RA3  substances were discovered to be carcinogenic or toxic.15*
        ;:=  ?R 3-19i (September  23,  1974)
      . s»  «
          •Is,li_grai : N'e^ 1 ect,  Joseph Heghland, Marcia Fine, and Robert  Boyle.


     Rising public and Congressional concern prompted the President  to  ask  the
FDA to begin a large scale review of food additives classified  as GRAS.   That
review, begun tan years ago, is still continuing.  Any  ingredient which is
reviewed and confined as GRAS is transferred from the  original GRAS list at
21 CTS. 132 to updated lists--21 C7R 184 if it is directly added to food,  and
21 C?R 136 if it is an indirect additive which comes in contact with foods.
(Indirect additives are often substances used in package wrappings which  si-
grate in ssall concentrations to food they ccme in contact with.)

     The regulations specifically state that these lists do not contain all
GRAS substances (21 C7R 170.30).  The large number of such ingredients  makes  a
comprehensive list impractical.  This is especially true for  the "raw agri-
cultural commodities and other substances of natural biological origin" which
are used in processed food.  As a rasuit, the regulations recognise  that:

          A food ingredient of natural biological origin that has
     been widely consumed for its nutrient properties in the  United
     States prior to January 1, 1953, without known detrimental
     effects, which is subject only to conventional processing  as
     practiced prior to January 1, 1953, and for which  no known
     safety hazard exists, will ordinarily be regarded  as GRAS  with-
     out specific inclusion in Par" 132, Part 134 or Part 136.1 of
     this chapter.

Ingredients which do not fit this category are considered to  present a  higher
safety risk and are currently being examined through the food additive  re-
view.  If a question arises as to whether any substance is GRAS, the 7DA  has
administrative authority, subject to court review, to determine the  status  cf
the ingredient.  (21 C7R 170.35(h)(4)).  Similar authority concerning the
status of new drugs has been upheld by the Supreme Court.;ss

     As with food additives, the Commissioner may set conditions en  the use cf
a GRAS substance.  The FDA aay, for instance, find that a substance  is  GRAS at
or below a certain concentration on a food, when used for certain purposes, cr
when applied in certain ways.  This authority stems from the  agency's general
authority to regulate food additives and exempt GRAS substances -under 21  "JSC
§343.  If a manufacturer or processor does -ot comply with the  conditions sat
by the 7DA, then the ingredient is not GRAS for his intended  use.14'  In-
stead, he must seek a new GRAS approval for his particular use  or apply for a
food additive regulation permitting that use.
     l" Weinberger v. H-^r.san. V°stcstt.  and ^unning,  412  US  5C9  (19*2;.

     •"41 73. 526C1 (December 1, 1976).

        	,....'.-.'.5 .   fit, ti^es,  new evidence raises  questions ascut  ::he
c;.~-.~.*. ~~  ^  ~ccc.  ^cciti"^  CT j-r.JiS  5 ~.c^ ~ an c&.   1« <; ucr.  a  casst the F3A Ccsxn^.s*
sic-ar icay prc-au.gate an 'interim  focc  aco.it:.ve regulation   permitting con-
tir.uec us? of  tna -rocket  :.f it  is  "reasonably certain that  trie substance  is
net r.£™,7"..-  ?.n;  trie.  r:c r.s.T3 to  ~r J  ~M2l_; r.iidl^h well result frcis zha csr.~

''vr.£-ever  luLira':i=^s -he ^csciss-sr.er  aeeas  ^o be appropricire unaer -he  c.ir-
cur.stinca: . "   Iz  ac.ci.ior., -he sar.ufactvirer cr processor  aus1- show wi-'nin  50
c,2'-s '.-,c.  sv-d:',e.? ir.ves-igaiing  the  safety of r.lie substance  have beer, unde.r-
     . .is ;.-'--.  is  respcc.sir.fe rsr ragisterir-g pesticiaas,  reg-j..atir.g sethccs  cr
^.vp lii^-iiir. ,  and ssriir-g raleranca  levels fcr pesticide  residues on food.   As
axr.ij-r.ec  IT.  3.  pvevicus section, pesticide tolerances en raw agricultural
p^-ic-i-i are  regulatsc unaer 11 'JSC  §3-*6a.  Once tae processing of the  food
sftgms, r»cwaver,  t.ie FDA governs pesticide rstsidues under the food additive
                 a c- '- _-•
                                       that if.
                                         cctiror^zs vit^i «»
           r s s i .iu i ru.- T,S .
           good a.anufacturmg practices  are followed  in  processing to
           reacvs resi'-ues C-e. washing  and peeling),  and

           the  pesticide concentration on processed food does  not
           exceed the tolerance for  the  original raw  agricultural
men the  : DOC  »i'.l -.rt be "adultaratec."  (21 C7R  170.19).   Generally,  focds
;r.at exsesc  tae ro.erar.ce for their  raw  agri;
",er£"-ad  ar.i  birr id free interstate  commerce.
;r.at ex;:aec tae  :o.erance for their  raw  agricultural counterparts are adul-
     Bcycri  '.:,:i»"i. |?..ier.i_ r^las ,  the Conniss:.oner asy  further control a  speci-
fic oast^-,;c.e  on a urc-cessad  food through a food additive  regulation.  Ap-
proxisateV.'  60 pesticide chemicals  are governed by specific regulations  is  21
C7?v 193.   M.ar.y of these regulations control the application of pesticides  to
crops  aftsr  thay have been harvested or on wrappings and containers of bulk
rcccs    jriers  govern tne  application or pes::icic.e caesica.s to surraces  in-
side pro-assing plants.  Finally,  some raise the permissible resicue tolerance
';, a processed  fooc arcve  that  allowed in the raw product.   Such a rule  is
.•-sua.il/  oronulga-ed to account  for the natural .Increase  in residue concentra-
"-J.CJ-- t.iit  :c~^:rs whan a raw  agricultural commodity is  dried.  Some of  the
cr:.ec  procccts  £ ,:~».f:zed, for  instance, are raisins, prunes,  and teas.  These
::_gr.i*  7c.,'2ra.-cs:j ';,.iii be  ,;e.sea on the safety standards  required of other food


     The statutory and regulatory framework which divides authority between
the FDA and the EPA has produced widely different safety standards for food
additives versus pesticide chemicals.  The FDA is primarily restricted to  an
examination of health risks in approving food additives.   It examines the
benefit of an additive only to ascertain that it serves the function claimed
for it.  The Delaney clause limits the approval process by specifying that r.c
food additive aay be approved if it is found to induce cancar.  EPA, en the
other hand, broadly considers the risks and benefits of a pesticide chemical
used on a raw agricultrual product.  (21 USC §3«-5a).  Safety is balanced
against the usefulness of the chemical.  Thus useful pesticide chemicals aay
be used, and their residues may be present on raw agricultural procucts, even
if they are toxic or carcinogenic.  The Delaney clause does not cover pesti-
cide chemicals used on raw agricultural products.

     Food additives, then, are regulated under anuch more stringent safety
standards than pesticide chemicals, although they both may be present in food.

     An added exception (21 USC §342(a)), extends the safety test for pesti-
cide chemicals on raw agricultural products to pesticide chemical rasicu.es on
processed food--even though the latter are statutorily defined as food addi-
tives.   As previously noted, a processed food containing pesticide chemical
residues is not considered adulterated if it aeets the three requirements  of
21 C7R 170.19.  Under this provision, pesticide chemicals or. processed
foods--normally defined as food additives--do not have to aeet the safety
requirements for other food additives.  Thus, a carcinogenic pesticide chemi-
cal residue aay be allowed on a processed food, in contravention of the gena-
ral thrust of the Delaney clause.

     A final twist further complicates the safety standards.  If the concen-
tration of a pesticide residue en a processed food exceeds the ccrrsspcncmg
saximum concentration for the raw agricultural commodity, then the safety
standard exception from 21 USC §3^-2(a) does not apply.  Such a situation may
occur with dried commodities like raisins or teas.  Since they don't fit the
exception, these residues are again treated as food additives.  Their aaximum
permissible concentraton is set according to the traditional focus on safety
and the Delaney clause which prohibits the use of any carcinogenic substance.

     3;:;. tne statute  and  tne  regulations  define a "color additive"  as  any
rc'-s.r-.a_ t~at 'is s.  -ye, pigaent  or  other  substance. .'. [which] ..." when  applied
-: ,-. ;ce,;, irur   :r  cc».aetit,  or  the huaan body or any part thereof, is  capa-
;',~  'a..o:.e cr t.-.rough  reaction with  another substance) of iispcrting  a  cole::
            .11 -2"  §221.'t",  21 CTR  70,2-,'fy).   The regulations further  specify
            j.ser.  to  eye  packaging are considered "color additives" if  it  i;;
           forsshsole  that  taey will transmit soae of the color to the  con-
           e par.kiga.  Natural food  ingredients like cherries, that  add  thiiir
           o foocs  they  are  ci^ed with,  are not color additive unless  they  are
           erately  to  color  the other food.  Beet juice, when used to  iapa::t

           -, is a color  additive.   Finally,  aaterials used solely  for
                nan coBaring,  anc  pesticiaes  or nutrients us«a on procuce  ire
                color  additives."
     r.egul.= t ions concerning  ths  safety of color additives closely resezble  the
'.-Ifcj dedl.n^ .it":,  f.ci  ricitives.   For example,  the FDA nay not approve  the
use of s. c::lcr aaditive  unless "there- is  convincing evidence that establishes
with reasonable certainty  that no  harm will result from the intended use  o::
the color idcitivs.'1   (11  CTR  70.3(i)}.  In addition, the regulations  specify
that color acditives with  sisilar  pharaaco logical effects are presumed to have
added to;<_,:ity.  Food  additives  and pesticide chemicals whose effects  are
similar to these of a  color  additive are  also considered to be tcxicologic.il ly
acditive (.'.'. 177. 70.11)    Finally,  the approval decision focuses on safety
rises' :.t ::oes not  involve a risk/benefit analysis.  As with food additive;;,
tie safety factor used to  apply  aniaal data to san is 100 to 1 (21 CFR 70. -*0).

     AS with ether  substances  covered by  the FDCA , the FDA Coooissioner is
authorinec to prescribe  broadly  the conditions under which the color additive
sa>* be safely enplsy&c (21 CFR 70. i2).   Possible conditions include restric-
      (1)   licit ing  the  additive to use on particular foods, drugs or
           T.osaet ics ,

      (;,'   -,pecif"..-g  tae  aaxiaun quantity of the additive that aiay
           •.sea  in ary itan,.

      . ."   :nar»d&ti;:f  labeling,  directions, or packaging which the
           icditive  oust bear to assure its safety, and

      ;,-^   i^ec ,,rvmg  which dilutants aiav be used with the additive.


     The statute directs the FDA to consider -the probable consumption, cf the
additive before it issues a regulation allowing the color to be used.  When
examining such, information, the FDA may discover that the color cannot be
safely consumed under all of its proposed uses.  In such a situation, ragula-
ticns require the ?DA to solicit input from all interested parties about hew
tolerances for the additive should be allocated among the competing neecs.
After analyzing the various viewpoints, the FDA will decide how to allocate
the use cf the color (21 CTX 70.45).

     Regulations specifically mention the tests which will normally be suffi-
cient to determine the safety of externally applied color additives (21 CTR
7Q.42(b)).  The required tests include investigations of acute oral toxicity,
primary irritation, sensitization, subacute dermal tcxicity on intact and
abradad skin, and carcinogenicity by skin application.  (These tasting
requirements are analyzed in Volume I.)  Where any such test is not necessary,
the FDA may waive it.

     In implementing the Delaney clause the regulations differentiate between
color additives that will be ingested and those that will not be (21 CF3
70.50).  Whenever cancer is shown to be caused by a color additive that will
be ingested the additive cannot be approved.  Where the additive is not expec-
ted to be eaten, however, then the carcinogenicity of the substance will nor-
mally be tested by a route other than ingest ion.  Thus, a color additive which
causes cancar when ingested may still be used in external drugs and cosmetics
if its use in those products does not induce cancar.

     There is no GKAS category for color additives; all must be approved by
regulation before they can be used in foods, drugs, or cosmetics.  In addi-
tion, to guarantee the quality of color additives, each "batch" of a color
must be certified by the FDA.  (21 "SC §376(c)).  Where such certification is
not necessary to protect the public health, the FDA nay exempt the color acci-
tive from the requirement.  Approximately 150 color additives have been ap-
proved for use by the FDA.  Two-thirds of the additives have been exempted
from batch certification and are listed at 21 CFR 73.  The ether additives are
separately listed in 21 CFR 74.

     Before  1551,  the  ITJCA required the manufacturer cf  any new drug to demo
strate tn = safety  cf the drug before it was distributed  in  interstate com-
scree.  ~:.-  =,tatu: o~  provision:: were weak, however, because any New Drug
At-l_c£t.:.r  'NT* A)  was  autosatically arstroved at the enc  of  sis months if the
Ti~ r.i.r. r.ct  ns-eo an  order declaring that the drug's  safety had not been es
t-iol-scec.   I." strengthening tr.e FDCA, the Drug Anendaent of 1962 eliminated
-^e. autccitic  approval of drugs after sis ncnths.  Today, no new drug can be
rarxatec unless  the FDA has specifically approved a NBA  for the drig.  In
acc-itisr., the  1562 aaeadaenr now requires manufacturers  to  prove that their
r.ev arugs are  bcth safa ar.d effective.

Cher.ir.a 1 ii.ubstareas Covered

     Eegulstiriis irccnorate by reference the definition of "new drag" co::-
td.-^r — :.ie  statut>  ;,21 C" 21C.3).1Si  As previously  stated, the Drug
i-:^ncr:a-t rf 1?;2  rvar.ibits v'-iH distribution of ary "new drag" unless the Fu
z.i". -s.;_7rc;-=J 3 "OA csrtif/iiig "he drag as safe and effective.   Regulation:;
_2:plexe::t.,r.2 tse erjendaer.t insure that no "ae-too'1 drags introduced after
Jar.uary 1, 1562  will be marketed without ~DA approval.   Today, a product is
c^r.sidera;i 3 neu drag  requiring its own NUA if"(21 CFR 310.3):

      'i;  it is  comprised of any new substance regardless of whether
          it is  an active or inactive ingredient,

      2,  t*c  or 

     Actually, not every "new drug" requires a. complete N3A.  If the FDA  is
alraady satisfied that: a basic drug is both safe and aff active, it say requir
cr.iy an abbreviated new drug application (ANDA) for a new product.   (21 CF5
31».l).  "or instance, a manufacturer's generic substitute  fcr an already
approved new drug nay only re-quire an ANDA.  Because the issues are not ir.
question, an ANDA does not aeed to contain the extensive safety and effective-
ness proof generally required for a NDA.  The ANDA must contain any
information available to the applicant concerning adverse effects of the
drag.  As with a NLA, the applicant oust provide adequate data about the
bioavailability of tha drug--the rate at which the active ingredients ir.  the
drug become available at the site of the drug action.  (21  CFR 2}>.l(f)).

     Where two or more drags claim to be equivalents which  can be used inter-
changeably, the FDA may establish a bioequivalence standard which the drugs
aust aeet. (21 CFR 320.51).  (Bioequivalent drugs have tha  same essential
bioavailability.)  Drugs with an approved NDA, as well as those with an ap-
proved ANDA, nay have to aeet the bioequivalent standard.

     Vhen submitting a r.ew drug application, the petitioner aust provide  an
exhaustive report describing among other things, the chemical properties,
aanuf acturing techniques, safety, and eff activcaness of the drug.   (21  -FH
Sli.l).  In addition, the MBA must include copies of the labeling proposed fcr
use with the drug.  No drug will be approved unless the NUA demonstrates  that
the drug is "safe [and effective] under the conditions prescribed,  recom-
mended, or suggested in the proposed labeling."  (21 C7R 31-. 111).

     Unlike food and color additives which are approved largely upon an. eval-
uation cf their safety risks, drugs are approved for use only after a balanc-
ing of therapeutic risks and benefits.   "In practice, safe aeans that thera-
peutic benefits outweigh risks in a significant patient population . '* ~

     As a result of this balancing test, aany toxic drugs have been approved
by the FDA.  Drugs used in chemotherapy, for- instance, oftan have quite
harmful effects.  Vhen used, under the recommended, conditions, however,  tha
therapeutic benefits of the drugs outweigh their risks.

     Every new drug aust also prove, through substantial evidence,  to have the
affect it purports to have.  Substantial evidence demands "adequate and well
controlled investigations, including clinical investigations, by experts _.-'
qualified by scientific training and experience to evaluate the effectiveness
of the drug involved,"  (21 CF5 31i.lll).
     i51Coc?er, "The Role of Regulator-/ Agencies in Risk-Benefit -ecisior.
Making," 33 Food. Drug, and Cossetic law Journal 753  (1378).

      r.  ri'.r ;nei SsiiiiV rec°-iires3er.; is  is'oosec cr.  -r-gs con~di.in.ng msu-in or
£i.t _:'.ctic.;.   3uc.r.  ^rugs ~'jst  rscsive  mi cfir*i.ncji~ ion .ici  every ba~cr.
"rccuiei,  is  well  2.3  ~eetir»g  ~ne zsneral' ssf&rv  inc effectiveness reG"wi.reajen~s

sr.srrr":  sr.  ir.;i~i2"ic  f_r:n:  2£.^ch cer'ifica^ior. i:f i~ is "not  necessary"  to
ir.sure  Sa,r*~7 &na  arficacv cf  use.   ^11  -5C I257(c)).

Chemical Substances Covered

     Repeating the statutory definition, the regulations  identify  a  "new
animal drug" as "any drug intended for use in animals other  than man,
including any drag intended for use in animal feed but not including such
animal feed."  (21 C7S 510.3).  Like the statute, regulations  specifically
exempt drugs which ara:

     (1)  generally recognized as safe and affective  (GRASS) and
          which have been used to a material extent under the  condi-
          tions recommended on its labeling, or

     (2)  pre-1938 drugs which were subject to the Pure Food and
          Drug Act and whose label representations concerning  condi-
          tions of use have not changed.

     No new animal drug may be sold, distributed, or  used in interstate  com-
merce unless the FDA has approved a new animal drug application  (NA2A) which
demonstrates that the substance is safe and effective.  To avoid the type of
problems that occurred when drug manufacturers tried  to mar-cat their "re-tcc'T
drugs as GRA5, an animal drug is considered new, and  requires  the  submission
of another NADA whenever (21 C7R 510.3(i)):

     (a)  it is comprised of any new substance regardless of
          whether it is an active or inactive ingredient,

     (b)  two or mere drugs are combined into a new product, even  if
          the individual drugs were previously approved,

     (c)  ingredients are combined in new proportions,

     (d)  it is intended for use in a new species of  animal,

     (e)  it is used in a new way to diagnoses, cure, mitigate,
          treat, or prevent a disease, or to affect a structure  or
          function of the animal body, or

     (f)  it is used in a new dosage, or administered differently,
          or any other condition of use recommenced in the labeling
          is changed.

     Animal feeds which contain a new animal drug are also governed  by  tr.e
FHCA and its regulations.  Increasingly, animals grown for food  production  ar=
being treated with drugs added to their feed.  The drugs  decrease  procucer's
and consumer's costs by reducing losses from diseased animals  and  increasing
yields.  No feed containing a new animal drug aay be  marketed  unless the  ~A
has approved the feed.  As a first step toward that approval,  feeds  can  ;nly
contain drugs that have already been approved as animal drugs  by tne FHA.   "-'.

     .::e "egu.ations  do  not  expand en -lie statutory safety  standard prescribed.
for £ new ar.ir,:.. drug.   They repeat the requirement tnat  the  "DA say net
3r_-r=v-- = N.-JIA   unless  i -  finds  tnat -.-a applicant has demons-rated that :he
erv.g will 'z-i  'safe  and  effective uncer its intended conditions  of use'1 (21 CFE
51-. 1C5 : ::l-.lll).  As with  new  drugs, the safety decision  ;.s based or a
b_3'._an.c_a =:: the taerspeutic risks and benefit:; cf the drug.183   The
pet ant 12.1 e_£o:::vBi_c  Benefits  cf the crug i^ loweriig the costs cf aaat arid
CL .ry troiiucts are  r.ot  »ot.sidersd.

     .-..t.-.-ugl-. the applicant  proposes conditions of use in his N'iDA,  the ~A
sets tr.s .fuial ccnditions  in its raguiation approving the drug.   Such conc.:,-
tions say ir.cluda allowable  aethods cf use; dosage levels;  vithdrawal per:,cds
sefcra  :lduzr,ter; tc'lerancas for tne crug or its metabolites  in edible prod-
ucts cf fcic-prsiutisg  animals;  labeling or other requirener.es  necessary :o
assure  sa::= and  effective  use cf crugs used in animal feeds;  "or other use
res ;ricti;;ns . "   (Li CF?.  51^.ICS).

     r^ei;: tor-ar.ning sew  aniaial drugs will only be approvec.  if the drug i.s
•os=d _r. tr.a jeed acccrcirig to the conditions established  by regulation vns:n
tns cr-ug vas approvec ,'21  CSC §260b(M); 21 CirH .556.4).  To  further ensure the
safer-  cf feecs  containing new anisal drugs, the nanufacturer of a drug ir.ten-
iad for use in feed sust have a  written statenent from the  person receiving
th-3 c.rug tnat .ie holes  an  approved anutal read application  issued by the FDA

     An additional  safety  standard is imposed on antibiotic new aniaal drugs.
As provided by statute  (21 USC §357), any antibiotic drag coaposed in any part
cf penici,.lm. streptomycin, chcrteracycline, cb.ioranphea.icol,  bacitracin, or
ar.y cf  t.-<=ir derivatives aust also receive FDA certification  for every batch
prccucsc ..n adcition  to  seating  trie general safety and effectiveness tests.
Th* ~D« sav exempt  an antibiotic frca batch certification if  it is not neces-
sary tc insure that the  drag "conforms to the standards of  identity, quality,
anc purit^^  aoo.icacie  to  tne drug.

     ?-ars.;ar;t to thss*  safety standards, the FDA has promulgated several nisjcr
lists of regulations  concerning  approved new animal drugs.   Drugs that do not
require certification are  contained in Parts 520-29 of the  Code of Federal
Regulations, Title  Li.   Antibiotic drugs are listed in Parts  539-555, and
drugs use:; in animal  feeds are contained in Part 553.  In addition, toleriinces
far residues of  animal  drags in  food are detailed in Part 556.
      li:Cooper,  "Tne Role cf Regulatory Agencies  in Risk-Benefit Decision
Making,"  12  "cod.  Drug.' and Cosmetic Law Journal  756  (1978).


     As previously explored in the statutory analysis,  the  FDA's  authority to
reguiata hazardous chemicals in cosmetics is quite  lim  ced.   If the  government
can prove -hat a cosmetic contains "any poisonous or deleterious  substance
which may render it injurious to users under the conditions  of use prescribed
is. the labeling...or...as are customary or usual,"  then the  cosmetic is  deemed
adulterated and barred from interstate commerce  (21 USC §361).  The  FDA  has  no
authority to require premarket clearance for cosmetic ingredients.

     Under -his  limited authority the FDA has  issued regulations  prohibiting
or severely restricting the use of the following cosmetic  ingredients:

          •    Eggs in shampoo preparations

          •    Bithicnol
               Vinyl Chloride  in  aerosols

               lialogenated Salicylanilides  (tribromsalan--T3S,  3,
               4', 5- tribromosalicylaniiide, dibrotncsalan--G3S,
               5-dibromcsalicylanilide, oetabromsalan--KBS,  3,
               5-dibromcsalicylanilide, and  3,  3!,  4,
           •    Zirconium  in  aerosols

           •    Chloroform

           •    Chlcrofluorocarbons

Those regulations  appear  at  21  C7R  TOO.

     Despite  these  actions,  a  1973  report  by  the  3AC1S"  concluded  that  about
125 chemicals  listed  in the  Cosmetic,  Toiletry, and  Fragrance  Association's
Cosaatic  Ingredient Dictiior.ary are suspected of  causing cancer; about  25  ara
suspected of  causing  birth defects.   In  total,  approximately 600 of  the 2,750
ingredients reviewed  are  at  least suspected of causing toxic effects.   The
chemicals  are  still used  in  cosmetics, however, because  the  ability  of  these
ingredients to cause  toxic effects  through cosaetic  use  has  not been catar-
      •"*  Lack  of  Authority  Kanreers  Attenrpts  to  Increase  Cosseti: Safety,
General Accounting  Office,  August 3,  1973.   HSJ3-73-139.

    ." r.i.carc;us  coszetic ingredients,  t.ie J"~-. has issued  several regulations

          :rccuc:i=r ars requested  tr.  f..le procuct ingredient stata.ner.ts  (jll
           )    5-oh stateaents woiilc  ioentif" the comocsition of each
_r.zraci~r.^ usec.  in the cosaetic.  ?iaally,  :~d'.isiry  firas  are requested tc
f-,le vc I".:."Err  rsrjcrts about ar.v  acverse cr unusual  cosmetic reactions about
v::i=h :-*.  f.zn  learr.s '[21 C~ 7QC.30).


                               MEDICAL DEVICES
Substances Covered

     The Medical Devices Amendment was designed to insure the safety and
effectiveness of devices used "in the diagnosis of disease or other condi-
tions, or in the cure, mitigation, treatment, or prevention of disease, in mar.
or other animals."  (21 USC §321 (h)).  Familiar medical devices induce pace-
makers, x-ray machines, and lUDs.  Although the amendment was not proposed to
regulate potentially hazardous chemicals, any toxin which is contained in a
"medical device" and which makes it unsafe, may be indirectly controlled by
restrictions en the device.


     The statute creates three categories of medical devices (21 'JSC §360(c);
21 C7R 360.3).  The safety and effectiveness of a Class I device can be as-
sured through the general provisions of the statute dealing with labeling,
adulteration, record-keeping, registration of producers, and the banning of
hazardous devices.  The safety and effectiveness of Class II devices can be
assured only with additional provisions requiring the promulgation of an FDA
approved performance standard.  Finally, Class III devices are those wnich:

      (a)  present a potentially unreasonable risk of illness or in-
          jury, or which

      (o)  are used in supporting or sustaining huaan life, or ara of
          substantial importance in preventing impairment of human
          health, and which cannot be safely regulated as Class I cr
          II devices,

require premarket clearance by the FDA before they can be scld.

Approval Criteria

      A Class III device will not receive approval for marketing unless the
petitioner applying for clearance demonstrates "reasonable assurance that the
device is safe  [and effective] under the conditions of use prescribed, reccn-
mended, or suggested in the proposed labeling thereof "(21 'JSC §26Ce<.tXzy) .
While the .regulations do net elaborate on the safety criteria used for the
particular decision, they do clarify the health-based risk/benefit considera-
tions generally applied to medical devices.  In categorizing a device into
Classes I, II, or III, for instance, the regulations specify that the ccjecc
is safe when the probable health benefits of the device, wnen used as inten-
ded,  outweigh any probacle risks  (21 CF3 560.T(d)).:5S
      •*'A similar test is us ad to determine effectiveness.  A device is ef-
fective when a significant portion of the target population that uses the da-
vica  according to its Intended uses experiences clinically significant results
'21 ™?v 360 . T (e)) .

           ".-= rsgulaticr.  prcvic.es tr.ct tne  FDA nay :incer~s.ic.e such action

                                                                       Is  £T
          .:,zcu~ wr.srr.sr  -r.e  risx. cf __lness  cr injury is  subs;ar.~iai. .  "he  "DA
vill cc~sic.ar  '.'h e^ner  the  c,ecep~ior. cr  risk... is ispcr.ajir ,  nsterial  or
sigr.if iia.'.r  ir. relanon to  the benefit to  the puolic health  ircz  [the
cevica ' ?   ccr.tiruec sarketir-g."

                       U.S. DE?A?.TH>'~ C? AGRICULTURE
     The following reviews cover thrae statin as and  regulations proculgatsd
under these acts administered by the Department of Agriculture  r~S2A) .   Tha
statutes include:

          •    Federal Meat Inspection. Act

          •    Poultry Products Inspection Act

          •    £35 Products Inspection Act

     The legal reviews and regulatory analysis that  follow dc not  necessarily
represent the official position of USSA.  Moreover,  this satsrial  has  net  bee:
officially endorsed by the EPA as its understanding  of USDA authority.   The
contractor, 1C? Incorporated, is solely responsible  for all analyses  and

                    INSPECTION ACT.1- AND Z3G PRODUCTS

    The Federal .Meat Inspection Act (FHIA), the Poultry Products  Inspection
Act (??IA),  and Egg Products Inspection Act (I?IA) provide  for  routine,
mandatory federal inspection of slaughtering, meat-canning,  salting,  packing,
or rendering operations, or similar establishments which  slaughter  certain
livestock or poultry and process the products.  The Acts  also cover
establishments and facilities which process eggs and products made  from  them.
If the operator of a plant refuses to destroy any "adulterated" products  when
have been condemned, the federal inspectors may be withdrawn from his
facility.  This sanction is a deterrrent,  for most meat,  poultry, or  egg
products cannot be sold in interstate commerce unless  it  has not  been
federally inspected.  Criminal and civil  actions may also be initiated
concerning dealings in adulterated, misbranded, or uninspected  products,  and
other violations of the Acts.

    Two of the Acts, the FMIA and the PPIA, were updated  and expanded by  the
Wholesome Meat Act (VMA) in 1967 and the  Wholesome Poultry  Act  in (V?A)  in
1963.  Since 1906, meat and meat food products prepared for interstate or
foreign commerce have been regulated under the Federal Meat Inspection Act.
Poultry products prepared for interstate  or foreign commerce have been
similarly regulated since 1957 by the Poultry Products Inspection Act.

    Despite these earlier Acts, a large amount of the  nation's  aeat and
poultry products was not being inspected.  In 1967, for example,  15 percent  o
the animals commercially slaughtered in the United States for aeat  were
regulated only by State laws because they were not prepared for interstate or
foreign commerce."-  Hearings before the  Senate Agriculture and Forestry
Commission indicated "that Z5 percent of  commercially  prepared  aeat products
[were] prepared without Federal inspection and to a significant degree  r_ver=]
not subject to adequate State or local  inspection."*-  The  House  Agriculture
Committee found in 1963 that 13 percent of the poultry slaughtered  in tr.e "J.5
each year was not subject to Federal inspection.SJ
     l-21 USC  §601  et  sec.

     :-21 USC  §4.51  e_t  sac.

     :-21 USC  §1031  e_t  3°q.

     "-3. Rep. No.  799,  90th  Cong.,  1st  Session,  1967,  reprinted in 196
  .5.  Code  and Cong. Ad. N'ews  2190.
     *-H.R. lep. N'c.  1222,  90th  Cong.,  2nd Sess. ,  1363,  reprinted in 196
U 3. Ccce  and Ccr.z.  Ad.  N'ews  3-27.

• — «-*>*•— — • — — — *S *•»..-•• ^* J w .  ?1 £,.... w «_.» u« v ', 1* ^** £"» /  •. w *lw^l^ .»*..«_ _ w w £ ,  wwwO€..SL.e * _ _ *A ,
anc oarti.illv func  State  inspection  crogracs . '-   After an initial  period,
tr.e Se^rrtary -as to  extend  tne  Federal Inspection program to  meat cr  poultry
preparsc for ir.~rs.sr3-a cccmerce IT.  any scare vh^:h failed cc  develop  or «*as
           ,•,'&-:.• e-fariing  reqiiirsments equal zc federal reruirener.es.
           .is s-aruze which  covers  prodac-s z'zaz are "ir; ineerstace  or foreign
             suoszar-tially affect  such ccrnaerce," Congress exercised its
    Tne i'sceral Meat  Inspection  Act subjects foreign facilities  wr.ich oraoare
seat :cr ercpcrt to  tne  wnitec  states to recuireaents at  .east  equal  to t.iose
spplicacle to coaestic  facilities.8-   Foreign poultry estaclishnerits  are
subject ;.c similar  regulation."11'
    ~z& :l?Ii, enacted in  1ST3,  subjected aggs and egg products  to  safety and
inspection stancarcs similar to those employed by the VMA and  V?A.   Congress
found that "eggs  and egg  products  are an iapcrtant source of the Nation'.5
total supply of food. ...  It is essential, in the public interest,  that the
health and welfare  of consuaers be protected by the adoption of measures
precribe-: nere_n.''  This  Congressional Statement of Findings cites destruction
of 3ari:e.:s. unfair  competition, and consumer injury as ills that  the  Act is
    Eacn of tse three  Acts  deals with the primary substance  (i.e.,  poult.ry,
seat, eggs; and the  "products"  of the substances.  "Meat"  is not  defined,  but
"poultry'  is defined as  "any domesticated bird, whether  live or dead,"11-
and "egg''  is defined as  "the shell egg of the domesticated chicken,  turkey,
duc.<. goc.se, or guinea". :3-
     T-'I1 "J.S.C.A.  §§  45- (??IA) ,  661 CFMIA) .
      -S«e  Ibid. ,  §  -i-66,  9  CF?v 3S1, Subpart ~ .

     '•••  Ibid,  §  102 1.   This parallels the Congressional  findings for the
    •-  (§  "ii;  and  the FMIA (§'oC2).

     ::-  Ibid..  1-53 (e).


    The "products" of these three substances are defined  in  -ha  sane  general
3 anr. e r :

         •    "Meat food produce" includes any produce capable cf
              use as human food and which is made entirely or
              partially from the meat or any other part of the
              carcass of cattle, sheep, swine, goats, or  equines .
              The Secretary may exempt (1) a product which, has a
              "relatively small proportion" (undefined by the sta-
              tute) of meat or other portions of the carcass, or  (2)
              products which "historically have not been  considered
              by consumers as products of the meat food industry
              •under such conditions as he aay prescribe to assure
              that the meat c: portions of the carcass used  in the
              product are not adulterated and that such exempted
              products are not represented as meat food product. "*-

         •    "Poultry product" includes all or a portion of the
              poult— / carcass and any product that is wholly or
              partially composed of the poultry carcass or a por-
              tion of it.  As with the definition for "seat  food
              product", the Secretary aay exempt a product froa  tne
              definition in a d_e sir, is is situation anc. where

              as coming from the poultry  food  industry under  such
              conditions as he may prescribe to assure that the
              exemption does not result in the use of adulterated
              poultry ingredients and that exempted products  ara not
              represented as poultry products.'SJ

         •    "Igg products" include "any dried,  frozen,  or liquic
              eggs, with or without added ingredients."   The  sane
              two exemption situation exist, subject to  the sane
              kind of regulator*/ action bv ehe Secretarv of

    One reported case''7- deals with the exemption  from the definition of
"poultry product."  At the time this case was  decided, there  was different
statutory  language that authorized an exemption:   "CVinless exem-gtsc.  b-- the
Secretary, any human  food product consisting of any eligible  part of  poult";
     '•'•  3orcen Co. v. Trseman,  :55  ?.  Supp.  ;92  (D.  S.J.,  l-cc),  aff' i 29-
7.Id -Ot,  cert,  ceniea,  236  C.3.  2c9.

      t  'an:c.~s.si3 addad%> .  The  Court  considered the statuto.rv exe:c™ticr.  t;3
      'seer. .iirswr. with  2. view  to relieving the Secretary of the unc-ly
      .s "riK ".3.3?" of suoerv: s ir.2  "hs  asniif ac~ure ir.c S3.is cf 'irocucts  tr.s."  '".2vs
     Tne reg'-l=.::icr  in question  had exenptec. products (this particular
l;,-.5£.t«c~ csncstrned soups) vith less  than 2* poultry naat and, among other
things, t,-. = t had no  false  cr  misleading labeling.   Tne court found the
           a reasonabe  definition  of what products ire to be
          considered,  exezpt  fron  the tera "poultry product."  This
          regulation  is  "a sensible  exercise of judgment" by the
          Secretary;  for it  provides for the best possible workable
          cocprccise  between the  policies of (1) insuring against
          the use cf  false or rsisleading labels and (1) allowing the
          Secretary to divest himself of jurisdiction over products
          vr.ose poultry  content  is ainisial . : *-

Altnougn the ca.se does not specifically address seat or egg products,  rh is a ceiling), and (2) the percentage oz
rr.e g*nc>ra.l product (e.g., poultry soups) that are execptad cannot be  too
large (it is net clear tnat  90%  still subject to regulation is a floor).
    Cne of tne major  concerns  of these Acts is to protect the  public  from
adulterated  food  products.   Each Act sets forth criteria, only one  of which
irust be aet.  for  a  covered  product to be considered adulterated:

          •    A product  is  adulterated if it bears or contains a
              poisonous  or  deleterious substance that may make the
              product injurious to health.  If the poisonous or
              deleterious  substance is not an added substance,
     ;!-  Ibid.,  o.  600.

               however, the produce will not be adulterated  if the
               quantity of the substance "does not ordinarily randei
               [the product] .... injurious to health. "i:-

               A product is adulterated if the Secretary considers
               it unfit for human consumption due to an added
               poisonous or added deleterious substance borne on or
               contained in the product.11-1

               A product is adulterated if it is wholly or
               partially a raw agricultural commodity and bears or
               contains a pesticide determined to be unsafe  under 21
               § 3^6a  (Food, Drug and Cosmetic Act (7DCA)),  if it
               contains a food additive that is unsafe under § 3-3
               (FDCA), ox if it contains a color additive that is
               unsafe under § 376 (FDCA).   Even if a substance
               within these three categories is considered safe
               under the FDCA, its presence in cr on a product will
               make the product adulterated if the Secretary has
               promulgated regulations prohibiting the use of the
    ilJ21 U.S.C.A. §§ 453fg)(l)(A) (?PIA), 601(31) (1)  (7MIA), and  lC32(a)(l)
(SPIA) (emphasis added).

    2J-  Ibid..  §§ i53(g)(2)(A) (??!A), 601(3)(2)(A)  (7MIA),  and
lQ23(a)(2)(A) (I?IA).

    Z5-  Ibid..  §§ 453(g)(2)(3)-(D) (??IA), 601(m)(2)(3)-
               A crccuct is aau.tsrite::  _r  it vnc_-y  cr  part..a_.y
               consists cf a decomposed, putrid,  or filmy
               surstar._e, or is for any  ctr.er reason  unsound
               ur.r.eal tr.y , unwr.olesome, or otnsrvise unfit  fcr human
               A procucr is adulterated  if  it has  been  packed,
               prepared, cr held under unsanitary  conditions  sc  that
               i. "either aav have becotce acntasizared with filth
               or] xav have oeccse injurious  co  health. I5-

               tnar. by s laugher cr,  in the  case  of eggs,  the  product
               is wholly or partially composed cf  eggs subjected to
               A procuct is acu.tarated  ir  it.s  container is  wno^^y
               cr partially coapcsed of  a poisonous  or  deleterious
               susstance that :r.av make the  contents  injurious to
               A product is adulterated  if  it  has  been
               intentionally subjected to radiation,  -unless  the
               radiation, has been exeapted  under  § 3^3 of the
    Repcrti-d cases under the FM1.A have  interpreted the tera "adulterated.
a case dealing with excess fat, a seat  food  product was alleged to be
adulterated because fat had "beer, substituted  in  oart  for beef or ... added
    '"-  ILL=-- - -55Cg)(2)  (??1A),  601Ca)C3)  (?MIA) ,  and 1023 (a) (2) (EPIA.) .

    "-*-  IbJ;d., §§ i53(g)(i)  (P?1A),  601(a)(4)  (TMIA),  and 1033(a)(i) CI?1A) .

    Sl-  Ibid., §§ 453(gX5)  (PPIA),  601(m)C3)  (FMlA) ,  and 1033(a)(5) CE.-1A .1 .

    "-  l£^i-. i|""2U)C5)  (PPIA),  601(a)(6)  (FMIA),  and 1033(a)(6) (I?IA) .

    Is-  Ib:d., ii *53(«)(7)  (??IA) ,  601CaX7)  ("MIA),  and 1033(a)(7) C2PIA) .
         Ncte that each cf  the Acts  contains  a provision related to "econotaic
         a;:Lulteration""essentially  aaking a  sroduct  appear better than it
         is.  See ibid..  SS  i;2(g)(3)  (PPIA),"6Cl(m)(3)"(7XIA),  and
         lC22(a)(3)  (EPIA).  Note  also  that the FMIA,  § 601(ta)(9), has a final
         criterion that the  other  two Acts lack:   margarine containing aniiaal
         fat  is deemed  adulterated if any of  its raw  materials consisted i:i
         whole or in- part cf any  filthy,  putried,  or  decomposed substance.

so as to recuce the qua-ity or strengtn or  tne seat  rccc  product.  "-
The Court, in finding -hat the produce was  adulterated, noted 'hat

               [a]n adulterated product not only  includes  one not
               fie co be eaten, "but  also one to  which  almost
               anything has beer, added or extract ad  to  sake  the
               product seem better than it  actually  is."  (quoting
               U.S. v. 500 Pounds. etc., Veal and 3eef,
               319 F. Supp. 966, 967  .(N.D.  Gal.,  1970). 33^

    In the MDM case,31-1 the Unit ad States District Court  for D.C.  er.joir.ed
the Department of Agriculture fron giving further effects  to in intenced
regulation prescribing 3. standaro. for "aecnnicall;: debcnea seat ,MDM',  '   7_:s
court held that the Department did not comply with the  Administrative
Procedures Act in issuing the standards without public  notice 2nd  public
cooment.  The Court also rejected the Government's argument  that tne bcr.e
particles in MEM were really part of  the neat52-  and therefore,
MDM-containing products could not be  adulterated.  In this rsgara,  tne court
held that "meat" did not include MTM  because  it contained  bcne particles.  ~:
Court, however, noted that the record before  it was  an  inacecuate  basis  for
deteraining whether the use of MDM reduced  the quality  of  seat food products
(such reduction would violate the economic  adulteration provision  of section
6C1(3)(3)).  In addition, the Court noted that the Secretary was required

               to have aade a determination that  there  is  no
               substantial possibility that the presence  of  ocne
               particles in a concentration of  .i.5%  in  procassec
               products containing MUM could  ham the health of
               those ingesting the product.33-
    ''-1 U.S. v.  36Z3 Pounds. More  or  Less,  of  Veal  anc 5eef,  336  F.  Suco .
1-0, Ii3  (N'.D. Gal., 1971),  supplemented  332 F  Supp.  1C91    In aco.ition to
the "adulteration"  issue,  this  case dealt with labeling issues.

    33- Ib id.

    3 :- Comtnunitv Nutrition  Institute v.  sutz,  -23  F.  Suoo.  "51,  7£5
(D.C.D.C.,  197=).

    3 "-The  Secretary's  arguaenr  was based or. his  regulation  >. 9  37?.
3G1.2(tt);  that, in part,  provio.es that seat  includes  ''tne portions  of oor.e,
skin,  sinew, ner™."s, and blocc vassels vnicn ncmally accosoanv  ~ne c^uida
tissue and  which are not  separatee froa  it  in  tne process  of  irass.-j ''  Tr.e
Court, however,  reac this  not to include  "[g]rounc  up  bits zi bone entering
tne aeat  in tne aecnanica.  ceocning  process,  or  entering a processac seat -itn
the addition of MDM.  .  ."   Ibid.,  o.  735

             ;',: 1" ari-s  products  ir.  vmch it is used.

              .-  fir.cir.s  tnat  trie  bcr.s  "articles are no- de-t actable
              rv tcucr.  ~r  tasts  cess not satis f"* trie requirements
              cf Secticr. = ~1^, ;i;  (see tr.e first criteria discussed
              uncer  "Harm  to  oe  Avoided"; .

              Nutritional  benefit aicne is  nor a sa.fficien.t  reason
              :c: ;ind^r.g  Cur.der  sector. 6C1( = ),"-); that the product
              :t -ct  ir.;uricus tc health.
              ._^.. z.s  cctis^cie^ecL  a
              Secretary  considers several specific -questions  (raised
              ^LV me  rnecuca^  literature out not aG,o.r&ssec r^y  crxe
              Secrsti"*)  concer^uig the uscLioa.1 effects of the

    The .v.£r,t, roi-.try,  and  Egg  Products Inspection Acts do net specificallv-
require ~~.'~ ragulatsd  cosinesses  to  report incidents of. contaminations
:elatir-5 to fieiz products.  However,  anv sale,  transportation or  offer  for
sals or "onsy-crtation ~- use of  such products  a,ay trigger cri=ir.al  penalties
-.• ether e::f orcaser •_ actions under  the Acts.   Federal inspectors  are routi
present in plants where slaughtering,  preparing and packaging occurs.3S-
They carefully ir.spect facilities,  products and operations.  In addition,
rancon samples o: the  industries'  produces are  analyzed under CSDA's
scnitorir.g programs.   Finally,  conmercial sellers, buyers, slaughterers,
packagers, processors,  randerers,  warehouse operators,  and transporters aust
samtair; ''such records as will  fully and correctly disclose  all transactions
involved i:: their business.":'-   They mus~ allow authorized  representatives
c:" -.-c Secretary aocess to  their  facilities and the opportunity to  examine
-heir facilities, inventory and records.
    3S-Several snail  plants  often share an inspector who splits his,tiae
oetveen thaa.
    2s"-:i U.S.:.A. ||i60(b)  (??IA) ;  6«12(a) (FMIA), 1040  (Z?IA) .   The  £?IA
reocrtirig requirements  apply to "transporting, shipping, or  receiving .  .
cosaerce or he Icing  such  articles so received, and all egg handlers.  .  ."

                           ACT—REGULATORY REVIEW

    Regulations promulgated under these acts reflect the specific outline  of
the statures themselves.  In all three cases, Congress prohibits the  sale,
transport, or offer for sale or transport of any products which are
aisbranded, adulterated, or have not been handled, processed  and sold  in
accordance with the provisions of the act.

    Regulations under the Acts, as amended by -ha Wholesome Meat Act,  the
Wholesome Poultry Products Act, and the Egg Products Inspection Act,   were
first promulgated in 1970 for Meat Products,37-  1972 for'Poult--
Products,3 >J and 1971 for Egg Products.33-1.  The regulations  contain
mandatory inspection requirements and other provisions designed to prevent  zhe
sale or distribution of "adulterated" and nisbranded products.

    The regulations primarily complete the definition of "adulterated"  given
in the statutes by supplying the criteria for evaluation of facilities,
product quality, packaging, processing, and shipment of aeat, poultry,  and  egg
products.  The regulations primarily deal with required procedures, rather
than the designation of certain products or substances considered hazardous.
The next three sections discuss the aeat, poultry, and egg product regulations.
    The Mandatory Meat Inspection regulations are published  in 9 CF3.  3C1-22;
The regulations have specific requirements for procedures  involved  in
processing aeat from the live animal en to the cocking,  labeling, and
packaging of meat products.  The main section applicable to  this analysis  is
Part 213.7 dealing with chemical substances used in the preparation cf neat
products.  Meat products are considered "adulterated""0- and may r.ot be
sold, if they contain additives (as defined by the Food, Drug, and Cosmetic
Act (FDCA) ,  in quantities considered unsafe under the FDCA,  or contain ct.-.er
substances not approved by the Food Safety and Quality Service of USDA.
    3:-25 T3.' 1555^ October 2, 1S7C.  See 9 C7R 201 to 22.5 .

    3'-37 F3 9706 May 16, 1972.   See 9 CFR 231.

    3'-26 FR 98U May 25, 1971.   See 7 C7R 2259.

    *5-9 CFR 201.2(aa) Definition of adulterated.  See statutorv review.

.i—i.~;,ve:  ars  ir.itii.-..'1-" sva_uatac ~v  -j.-.,  out  -i^.i nav ace restrictions

prccucts    ; IT-v  213.7 contains a list c~  c..neaiial substances usec  as
ac--.t_vei   rr;c.^.c~s  rr.ey are used f;r. ar.d  aiiovabie cortcsr^ra-icr-s  of  -hose
used ur. :.r.e pro: ess ing cf near prscuc'r?  C-xnibi*  i-l).   These include  such
•;.-i.::gs a:, rir.^ers,  an-icxic.ar.rs, fl  -crir.gs ,  fillers,  enulsifiers,  and curing
5ger.rs.  Part  213.7 (b) also contains a special  discussion cf sodiuz nirrire,
2.sccr;£tfc, ini isoascorbare in bacon, focusing  or. resring requiraaenrs re
i-*:,;,-":.*:?• £:.d  li.r-.'.  nirrssazine (a suspecr  carcinogen)  levels after caotcing.
    M£r.s.£tor"?  Poultry Products Inspection  regulations are oublishsc  at  9  CFH
Z?",.  The^  ars  sisilar to the Meat Products  Inspection regulations,  describing
various pnases  :f  poultry processing.  Part  381.i"  contains a list of
siiTstsnces ,  including uses and aacunrs,  allowed  for the processing of poultry
    Regulations  promulgated unaer the Egg  Procucts Inspection Act  of  137C are
puolisr.e:.  =.~  ~ '~~~. 2S59.   They require  inspect :on of all egg facilities,
inclu-in.|;  procuctisn,  processing and pacl-cagr^rig  of egg products.  There is no
"-isTir.g '.-.  allowed or  prohibited accirives  or tolerances for contaminants in
egg prcc.:ci5 ,

                                       EXHIBIT »-l

                     7CCD  SUBSTANCES:    MEAT  PRCEUCTS  a/
I V xcstanct        Suoiune*
                : iod. aoou" citfn«  To ar«v«f»t cvnrtg    ?'*
                                                      •rvmtocx.            *ti«
                                                                         •0 m
                                                                               y   *oamm   ; v«i«
                                                                               10 3KXX -' rt»)»d           .30  - 	-	30   -  —.   	    ..30

                               	_ 3O  	3O  .		2O
                                    3O  	__^_,._	30. .	  ..- 3O          3 OO6
                                                                                       oon a,
                                                                                       •nn ;


               nyaraxyvv9o*«>                           or i comorvoon c(                  '^
                                                      lucn 'it ino

             3MT iburv»ai«<3          ...00..—..	.	.. .  	30		_.3o
                     	 00     	.  	3Q	„	  ..- 30
                             	...   	30   	„. .._  	30 			 3O
                          			3O .  -	.  .«_30 			_.  ..^.30
             T3K) uwni»ry          ..._3o			-.30 		    3O          0 C2 ;
                                   ..JO .	 .	JQ 		_ ._  0 03 3*rc**lt  A CC  5*i
                                                      >0wn u
                                                      lAusr;* Tiaoa "*m                 ;s^i*^i

                                    ao  ...._	JQ  	^.    so

                                    30                 30                 30


                                       To t
                                                              OMI or MCI trie
                 &HA iburncMS
                 BHT f

                                                                                                 0 CJ pwewil
                                      IKX! Ortlv
                                      •tin SHA
                                      M»»c an
                                    00' s«rc»ni
                                       To •rend ana
                                                            3r»«cir»; mi. uucn

                   IOMJIOM gumi
                 Sooum caMiniii

!•.  i', ,   • "^H
                                       To •nano and to
                                         subwn oroeuci
                                         ,«iio cam*-!


                                         1  oo        ....
                                       To rnvnum  umlorm
                                                         ... Eao ro»	
                                                            WMI «i-o
                                         i»rrv «c
                                        To c»or cannot or
                                                 ! 11:3

                     0 15 pwexit
  10? m Pmn 3IS 01
  tfn uiocnaonir
Imrtauon sausao*.
  nontoaotic ioa««3.
  totnN. nmn
                       Mfl «ro


                                  EXHIBIT  4-1  (Conrinued)

                            FOOD  SUBSTANCES:    MEAT  PRODUCTS
 <*••;« «l
  tour tie«anaru
Ciong samtttun   Aacerac sxa..
  --nun a uses am
  ft cmroruoon nmn
                                        To o>»»»oi '
                                          3« CJAT«3 goOOl
                                                            0 05 e»tc»m

                                                            001 33 m«at x ^«4i 3v-
                                                              ^•cCL-cr. '0 ;z.*csnt io*uu:n
                                                              la suiaess 31  r-icu  iuis
                                                              5ncr '0 sscxflOifK;. 1^.3 uf9
                                                              3) suen season  "--Jii  net
                  3k:- 3<=u«  CI
                                                               0 e«ecm  sjra •»»•:  '-i
                                                               :z 13 'CO * Ttt»i ir rruil
                                           'oca oraeucL         s-.-dc=jc: 10 svcsni v:^-

                  Soaun wtnorc^i* 	     3o —
                  C.KX *aa or voawn        ao ...
                                            ao .
                                                                .>. wvai ana
                                                                                 5on 01 a c.— r.fe
                                                                                 0' *7%oiaajr4 K7 sT-3 z*
                                                                                 uC^ or  '/I '0 2-J/C9f1t
                                                                                 'jon ji£3 13 irrcv ^.
                                                                                 01 curoo 0:13 rjnor -3
                                                                                 o<>-^ '.o
                                        To ':•« ?::K
                                                                                 •0  100 '5 ir>CC! ^r. --J0
                                                                                 :"<  ci :p TC o  ;.-.c:io
                                                                                 7* tin 
                  Scoum caoonata .... ...     so ....	
                  ZQ&vtri ctuconata ...  -       00     ....	
                  SOOHXTI rrvoro«o«  	      00  	. . .
                  Soowjm ri«i**'*caia          oo .-	- .
                                             oo   ... —	
                  2iac«vt tarnuc actQ
                    man ot mono aoo

                  vaono ano t


To amuisry orocuc:
  laijo is arOCUC.


3«no*r«c ammai tat   Svftxaent  'or
  01 a comsmawm ct    ana
  sucn tat wttn
                                    I tat
                       or a carnomauon r.t
                       men tat «*tri
                                                           05 !
                             wtafs ol
                    f«stnawl to
                    to ai
                             I animai tat    Suttioani -or puipoM
                       y I comom«tw»i of
                       IUCTI tat w«tn
                               i lai <
                            \ not :
                       by stanoaros ol
                    ana atrv«rwtsc rmMung

                    5 '2' i '.2CUI 01 trw
                    FOOO AOC3lln«
                             inv**o» (20)
                              l tor UM i
                       9*>«a 30005
                        used >ntn aoiYtonaia  60
                        ttw eowieinao total !:iaii not
                        •>ca«a '  Bwcant
                                                                      .. ana toco«ncs
                                                                 ano n tn«
                        »n« jrvcol.
                     ano o*sto^ ci
                     ana «ny aoos

                            i c"«j ot
                                                               Shonamng to 0» usm  3 0 p«rce"i
                                                                 lex ca»» ongt and
                                                                                     SuAo«nt lor suroosa
                                                                                                        aiorw :i
                                                                                       •K* cstrtsinoa aisi snan 1x31
                                                                                       aic**o '  aercam.

                                              CO  .


                                EXHI3IT  i-1
                           FOOD  SUBSTANCES:    M2AT PRODUCTS
»»ui«ma» and
                                   '0 3*v«»oc
                 u«ur» 01 trx
                 acjocomu* rye*. Hex
                 ton uwt«r or cuilus*
                                   ' 3 itaia flavor
               C-tnc 400
               Corn SVTUO VMS. corn
                                   To aonci
To flavor OroOUO


                  Cnm COrl carno
                  S«ua«o«  n.
                                                       ^>M sioducu

                                          (-wci«ci 'Uivor
                                                          i'  ana
                                                                        Surtio«ri 'o«
                                                                        0 !  svcant
i 0 ytKKit
  cr» ^AA

                                                                        2 5 owcern
                                    'o 't*y
ir-xa; an
•Wl III 14 tliC OUFW^
B«aioon«t« 01  JCG»_.
To no n
                 *nc«Cium oro»on»i*

    oo -
To we >

                                                                                Q 01
                                                                                  jro c»
x -----   .. —  ?tmn oo««

*3 --- -..___.  Dn«l ma«s
                                                                                301  Mrexni on  B»ta a'  '«;
                                                                                  content n comonauc" wnn
                                                                                0 01  swtft on Bun at uaui
                                                            Lure «na inonwuog
                 i<*oTy.iyve»oo« citriio
                                                            Lara  !f>ori*-'in$ "«n  3 02 pwcnm
                                                              oort :

                               EXHIBIT i-1   (Conrinuad)

                         FOOD  SUBSTANCES:   MEAT  PRODUCTS

                     SuOtane*             Puna*              ^roouca              A/nount

 . IOM ao*na    Sodwn BMHIITIM	 To rwnow nw          «oo. CWCUM*    Suflowi •« purcou
 i o« fniM»«u DT Sooun   o-               ao 	_.___._      ao		    Co.
num.           l«HC¥l grouo
                 graoonmntKr C..
                 C,i *na not M* Tan
                 99 owctm C. to C«J.
                SOOMTI ju««w ...... ..........     ao ....... — ..... ------    30 ------ ....... .. ......     So
                Soowrft mpo*ypfl9*CA4jM     do _____ _..«„«......    oo — ...... ____ .......    Oo.
                Su0QM ....... _____ ........      30 .„__ ______ ^ ____  .     3Q . ____ „.„„.„.„„    3o.
                Tnwaum ene*on«M ...      ao .- ..... -----------    do ...... ----------    Co
                Pouaawn tom*tt -------- To rviara mou grown  Or? uus*)» ................. 25 9«c«nt » ««i«.  sauoon
                                                                            •nar  Kuttcno.  or
                                                                            nwv &• aoo*a m  tauaon
                                                                            jm to stuffing.
                                    To y«««rK prooucl   Cl•<»'^•rq«m• or      3.1 3«fe»m 3v »«•?" " in»
                                      and !o rcura moid     rmr^nn*.           Wanw ^•omw^ann*  cr
                C*eun onoaum. £DTA To arn«r<« anauc.       90 ....... --------- 7! »m 9«r -mtion ?
                 icxoum aaooum       ma '.a prowc: n*vor                       21 TO
                     paraocn ipfooyt   To nt«rs moM grow  Ory uu»g« — ------ 2.3 swewil n ««t«r  joiuuon
                                                                            rn«v M »oo«el 'o  ca
                                                                            tntr  nunmq.  9r  u
                Soaum.Bcveon*u ------- TO fmmta» ocna   RvntMrx) !aa. xuct.  SurtiaOTn icsr aurcos*.
                                                         cjnnq pou*.
                               ........ To r*wa motd jroirtl  P^3» avst ------ __ ..... O.
                                  „     OQ ..... ___ ._ .........      30  ...............     Oo
                Sodmyn n^aroiia* .......  To CWCTWM imoum   Caifu n«mi. porn     ««» 9« -u*a oniv n
                                      91 C9OMO out MOM.   snouo»r >c'j-j ina    'xxi  WITT:
                                                         loma. onn«4 rums    rioo 31 iou>  ^i
                                                         «oa am mouxMr     onan to  sr«  p
                                                         pr^wa. «na          »vcroi»»:  :n« ccmorv««xi
                                                         jrooucu co-rarw By    snail not «c*«d S  :7rc>r»
                                                         }319'0*ai;         ui  ami*  11  10
                jaoofjfn arrn  al
                                                                                 .n >oouct lo
                                                                            soiuooo  -nay  a*
                                                                            ^im e>oovx::!.
                                        oo  ..........      ao        .....     3o
                Sodnjn                  da         ....     30   ....         2*3
                Saoum rt>oiTO
       S -, 1 5 - 'i ~, \
       i" 5 a-1 S.~ i
    '4  ?ii»» fls
    « r .S 5 •« .2 lj -•'S
   "5! I • s §< i i i
    11 3?33= 5=5
    i~ S ; 3 s ^ Sag.

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iilMlaMHlHHI^a 5!
=-|s3S S§SS22SS3|    =
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fjlm'iu el;|
ruljunboli BO (p-j^Ds^olltilont
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tf «:|L'J« ol fall end lolly icldi

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1 _ 1

    Tha Cw-suaar Produce Safety Ccaanissioc.  :.s  rsspcasibia for -he .^plementa-
ticr. ;f tr.::ae Aczs of Ccngrass ccncarr.^r.g hazardous  chan^cals :

       -  •    Federal Hazardous Substances  Act,

         *    Poison Prevention Packaging Acr.

         •    Flammable Fabrics Act,  and

         *    Consumer Prsduc- Safety Act.

    The statutory and ragulatory  reviews  that  follow do not necassaril"
r?prasent the official position of  the Cctnmissr.cn and have not been reviewed
or aprrcvec by the Cccaission.  Moreover, this  material has not besn officialy
f.ndcrsad by -;ha EPA as it understanding of  CPSC authority.  The contractor 1C?
Inccrroratad _s solelv resoonsibla  for all  analyses  and ir.tarorstations.

                              ST.VTJTCRY REVIEW

    3y I960, advances in the field of applied chemistry  had  resulted  in  2
proliferation of new and useful household aid products which, while quite
beneficial overall, had outstripped the ability of existing  regulations  to
help prevent ham resulting from their use. :j  The Federal Caustic Poison
Act had been enacted in 1S271-1 and required  informative  labeling  of only a
fraction of the potentially deadly chemicals then on  :he marxat.  Similarly.
the labeling requirements of the Federal Food, Drug,  and Cosmetic Act
(F2CA):-  and the Federal Insecticide, Fungicide, and  Rodenticide  Act
(FIFRA)*J were not sufficiently broad to adequately protect  the public.5-
These facts, together with the estimated SCO deaths annually resulting  free
500,000 incidents of children swallowing household aids  ana  t.-e additional
death and injury to adults from household substances  sot bearing  cautionary
labels, cromptad the passage of the Federal  Hazardous Substances  Labeling A:
in I960.'-
    .ae ,-icuse Committee on interstate anc .-creign ^rrsceroe  .xepcr-  statac  tr.e
purpose of the Act as follows:

         The purpose of this bill is to provide nationally  uniform
         requirements for adequate cautionary  labeling  of packages
         of hazardous substances which are sold in  interstate
         commerce and are intended or suitable for  household use.

              The labeling requirements will advise the user of
         these hazardous substances in the use cf t.ie product  and
         sake available immediate information  for physicians wno are
         called upon to treat cases of accidental injury.   It  snculi
         also provide a pattern which States may follow in  enacting
         similar legislation.'-
    ;- H.R. Rep. No. 1361, 36th Cong., 2nd Sess. ,  reprinted  in  "J.3.  Tcda
Cong,  and Ac. News 2333, 2334  (I960)  (hereafter  cited  as House  \epcrt".

    '• -5 USC -Cl-ill  (partially repealed by the Federal Hanarccus  S-icstan-
ces Act and i.s 1969 amendment).

    '- 21 USC 2C1 at sec.
     -  .  -iu i3o at SBJ.

    s-  House Report at  2S3i.

    > _  —* , -

     -  House Retort at  2323.

. .ie c.:i;:ir.= - -ict was.,  as  its  naze izrp.ies, ,t,.;iin.-y a  _aoelms,  act.   It was,
however, suasequ'=::t.y  brcacen&d   Ir. 1966, trie Act was  amer.ced1-  to allow
tr.e banning cf  coys  anc  ctzier chilcrer.'s articles as well  as  certain substan-

tne.T safe for household  use.   Tae purtscse cf this aner.caent was:

         [T]c ban tae  sale  cf toys and other children's  articles
         containing  hazarcous suastances;  to authorize  the Secretary
         of Hftilth,  iiuiaricr:,  and Welfare ts b,=r. the sale cf ether
         s iibstances  whicc. are sc hazardous ir. nature that  they car.-
         .ict De aace suitable fcr use in cr .ircunc the  household  by
         cautionary  labeling; to extend coverage of  the  Hazardous
         Sue-stances  Labeling  Act to unpackagec as well  as  packaged
         hazardous  substances intended for household use;  arid to
         ajake it clear tnat household products rrsated  with pesti-
         cides  are not exaapt from that act.1-

Tne naae sf the Act  was  changed to the Federal Hazardous  Substances Act
CrT-ISa^ , its present  title,  tc reflect this wider scope.

    The A;.t v>is  35a:.-,  aaended ir. 1569 to cover ^iaitrical, mechanical, and
-.•.erra.1 n=!.zarc,5 rcaec  a/ coys and othtr children's articles.10-1   The func-
"icr.s  of the Secretary of Health, education, and Welfare  under ~HSA were
    This statutory  review of FHSA will deal mainly with  the definition of
"hazardous  substance,"  "nisbranded hazardous substance," and "banned hazard-
ous substance."  Through a discussion of each of  these terss,  the workings o:
FliSA will ae  revealed.

     .-iSn celines   nazarcous suostance  as:

               (1)   (A)  any suostance or mixture of  substances  whic-
          ;i)  is tcxic,  (ii) is corrosive, (iii) is  an  irritant,
          fiv)  is  a strong sensitizer, (v) is flammable or
         combustible,  or Cvi) generates pressure  through
    *J Chile  Protection Act of 1966, Pub. L. No.  59-756,  80 Stat. 1303,
1304,  130.:.

    !- H.?.. Rep.  No,  2166,  89th Cong., 2nd  Sess. ,  reprinted in U.S. Code
Ccng.  and Ad.  News  »093 (1966).

    •s-'  Child Protection Act of 1969, Pub.  L. No.  91-113,  33 Stat. 187-189.

    '. '..  • ~  •• --  "• - C I" 3 1
         j. .1  w » w  .. -1 7 v a j .


         heat, or other me'ans,  if such substance or mixture of sub-
         stances may cause substantial personal injury or substan-
         tial illness during or as a proximate result of any cus-
         tomary or reasonably foreseeable handling or use, including
         reasonably foreseeable ingestisn by children.

              (3)  Any substances which the Secretary by regulation
         finds, . .  . meet the requirements of subparagraph (1)(A)
         of this paragraph.

              (C)  Any radioactive substance, if, with respect to
         such substance as used in a particular class of article or
         as packaged, the Secretary determines by regulation that
         the substance is sufficiently hazardous to require labeling
         in accordance with this chapter in order to protect the
         public health.

              (U)  Any toy or other article intended for use by
         children which the Secretary by regulation determines,
         ...presents an'electrical, mechanical, or thermal"-1

The categories specified in this definition are carefully defined in FKSA.
Exhibit 3-1 lists the definitions of the categories mentioned in
§12Sl(f)(1)(A), while Exhibit 5-2 lists some of the definitions used in
§12Si(f)(1)(3)-(D) and elsewhere in the Act.  Exemptions from this definition
of "hazardous substance" for certain substances covered by other statutes are
given in §1261(b)(2) and §1261(b)(3) :

         (2)  The term 'hazardous substance' shall not apply to pes-
         ticides subject to the Federal Insecticide, Fungicide, and
         Rodenticide Act, nor to foods, drugs and cosmetics subject
         to the Federal Food, Drug, and Cosmetic Act, nor to sub-
         stances intended for use as fuels when stored in containers
         and used in the heating, cooking, or refrigeration system
         of a house, nor to tobacco and tobacco products, but such
         terms shall apply to any article which is not itself a pes-
         ticide within the meaning of the Federal Insecticide,
         Fungicide, and Rcdenticide Act but which is a hazardous
         substance within the meaning of paragraph (1) of this sub-
         section by reason of bearing or containing such a pesticide.
    •-J see ixnioit o-_ ror cafinitions or  aiectrica.,   mecnanica.,  and
 'thermal" hazards.

    :3J 15 USC 1261(f)(l).

                 ?N;S CF TZ?.MS "SE2 IN" 13 'JSC 1261
                                    Shall apply to any substance  (o::her
                                    than a radioactive substance^1  which
                                    has the capacity to produce personal
                                    injury or illness to ssan  through  in*
                                    gentian, inhalation, or absorption
                                    through any bccy surface.   §12i:.^g).

                                    Airy substance which in contact vith
                                    living tissue vil! cause  destruction
                                    of tissue by chemical action;  but
                                    shall not refer to action on  insmi-
                                    mata surfaces.  §12sl(i).

                                    Any substance net corrosive vitr.in
                                    this section which on  immediate,  pro-
                                    longed, or repeated  contact  with  nor-
                                    aal living tissue will  induce  a  local
                                    inilaicmatorj reaction.   §1261(j^.

g S€:r.sitiz=r                        A substance which will  cause on  nor-
                                    mal living tissue through  an allergic
                                    or phctodynaaic process  a  hypers ess i-
                                    tivrlty which becomes evident on  reap-
                                    plication of the same  substance  and
                                    which is designated  as  such  by ::he
                                    Secretary.  Before designating any •
                                    substance as a strong  sensitize:1,  the
                                    Secretary, upon consideration  o::  the
                                    frequency of occurrence  and  severity
                                    of the reaction, shall  find  chaT  the
                                    substance has a significant  potential
                                    for causing hypersiensitivity .

            '                        Shall be defined by  regulations  is-
                                    sued by the Ccmaisision.   §1251(". )•

                                    Shall be defined by  regulations  is-
                                    sued by the Commission.*  §1261{'l).
 ~ 15 US" §1261 Cl) C4') provides:   "I'ntil  such  time  as  the  Ccm-
 Tiiasicn issues a regulation  .  .  . defining the  terra  "combusti-
 ble" as applied to  liquids,  such tera shall  apply to any
 liruid vr.icr. has a  flash point above  eighty  degrees  Fahrenheit
 [up' to ani including one hundred and fifty  degrees, as
 cetis—ir.ed ;y  the Tagliabue  Open Cup Tester.

                                 EXHIBIT 5-2


    Tera                                      Definition  and Section

Highly Toxic                             (1)  Any subs-3r.cs  which falls witnin
                                         any of the  following categories:
                                         (a) Produces  death  within icurtaer.
                                         days in half  cr  mcra thar. half of a
                                         group of tan  or  acre laboratory whita
                                         rats each  weighing  between two hun-
                                         dred and three hundred  graas ,  a:;  a
                                         single dose of fifty ailligrsas :r
                                         lass per kilogram of body weigr.t,
                                         when orally adamistarad;  or  ^V  pro-
                                         duces death within  fourteen days  in
                                         half or acre  than half  of a group of
                                         ten or aore laboratory  white  rats
                                         each weighing between two hunorac ar.c.
                                         three hundred grass,  whan inhaled
                                         continuously  for a  period of  one  hour
                                         or less at  an atmospheric concentra-
                                         tion of two hundred parts per -nillion
                                         by volume  or  less of gas or vapor or
                                         two milligrams per  liter by vcluse or
                                         less of list  or  oust, providec such
                                         ooncar.traticn is likely to be encoun-
                                         tered by aan  when the substance is
                                         used in any reasonaoly  fcrashed-Is
                                         aanner; or  (c; produces ceath within
                                         fourteen days in half or aors thar.
                                         half of a  group  of  ten  or -era rab-
                                         bits tasted in a dosage of two hun-
                                         dred ailligrans  cr  lass per kilcgria
                                         of body weight,  wr.an administered 07
                                         continuous  contact  with the ;ar=  s^in
                                         for twenty-four  hours or lass.
                                          ,_y   .r  t.ie  secretary  rinc,s  t.-.at

                                          w"' t h  an v s ub s t ^ ** ca  Tnd*^~-"3  ~asu"""
                                          dirrarant free tr.csa ootainec or.  ar.:
                                          aais  in  the  arove-nasec  dosages  cr
                                          concentrations,  tne huaan  cata snalJ
                                          take  precedence.   jlZsl^h^ •


     -/ennitior. ana Section
oi.all be defined by  regulations  is*
sued by tae Cotncission.   §1261(1).
A subs73c.ce r-hich  emits  ionizing
rs.ciac ion.
Art article nay be determined  co pre-
sent an electrical hazard  if,  in nor-
ms.! use or when, subjected  to  reasona-
bly foreseeable damage  cr  abuse, its
•ie.s iga cr manufacture say  cause per-
.Svir.al injury or illness  by eleccric
shoe/..  §I2£l(r).
Ar. article a ay be deterr.iiied to pre-
5«:r:t a mechanical hasard  if,  ir. nor-
mal r.se o: when  subjected to reasona-
bly .foreseeable  damage  or abuse,  its
design or manufacture presents an
unreasonable  risk of personal injury
or illness (1) from  fracture, frag-
mentation, a: disassembly of the ar-
        (2)  froa  propulsion of the  -
article  (or  any  part  or accessory
thereof),  (3)  from  points  or other
protrusions,  surfaces,  edges, open-
ings, or closures,  (»)  from moving
parts,  (5)  from  lack  or insufficiency
of coatrols  to reduce or stop motion,
(6) as  a result  of  self-acherir.g
char.actarisr.ics  cf  the atrcicle,
(""; >.ec,,j-use  the  article Cor any part
or accessory thereof) may  be aspira-
ted cr  ingested,  (3)  because o:
instability,  or  (9) because of any
other aspect of  the article's c.esign
or manufacture.   §12Sl(s).

                             EXHIBIT 5-2


Tara                                      Definition and Section

    Hazard                           An article may be determined to pra-
                                     sent a thermal hazard if, in noraai
                                     use or when subjected to reasonably
                                     foreseeable damaga or abuse, its de-
                                     sign or manufactzra prasants an un-
                                     reasonable risk, of personal injury or
                                     illness because of heat as froa
                                     heated parts, substances, or sur-
                                     faces.  §1251(t).

                  ..-.= ~er~  nazarucus suz-stincfe   sc.fi..  not  ir.c_ada  any source
                ,  special nuclear material, cr byprocuct  saterial  as  defined
        1.1 tne iirccic Energy Act of 195-,  as amensed, and regulations  issued
        rursuant cnersto bv the Atomic Enar;;" Commission.

   ~h&r  =.;•; thus  rwc basic --ays that a  subsiar.ce  is deemed hazardous  under
 5A,   Cne is taat  under 15 USC 1261 (f) (1) (3). , (C),  and  (D),  the  Commission
ay designate, sy regulation, certain substances  as  hazardous.  The  ether is
  the zfer-zs =: the statute itself,  15 U3C  12= l(f) ('.) (A) .  The  House Report
iscu3jid t^s .
              Further, as above noted, the bill requires that there
         be a risk of the occurrence of injury or illness' during or
         as a proximate result of any customary or reasonably fore-
         seeable handling or use' of the package or substance.  This
         phrase, again, is intended to be read in the light of the
         purpose of the bill.  This purpose includes customary or
         reasonably foreseeable accidental handling or use, not only
         by the purchaser or intended user of the product, but by
         others in the household, especially children who are prone
         to swallow or tamper with household aids left within their
         reach.  It is common knowledge that the very color and at-
         tractive modem packaging of a poisonous household sub-
         stance, such as furniture or silver polish, aay induce a
         small child to investigate and to swallow it.1*-

The Senate Report echoed aany of the points aade above by the House Report,,
and added:

         It is intended by the definition of a hazardous substance
         to bring within the scope of this bill those substances
         which, as packaged, nay cause substantial personal injury
         or substantial illness during or as a proximate result of
         any customary or reasonably foreseeable handling or use.
         Tnis includes ingestion by children whenever such is
         reasonably foreseeable (and the bill recognises that it is
         often reasonably foreseeable) .  It is also intended by
         these definitions to draw as clear a line of distinction as
         possible between the substances covered by this bill and
         the substances which are unaffected by its employing the
         language of the common law of civil liability in drawing
         such a line.  In order to insure that the definitions will
         include all substances which should be within the scope of
         the bill, these definitions are broad in scope.  They are
         not intended, however, to include substances where the
         hazard is minor taking into account on the one hand the
         risk or chance of injury and on the other hand the degree
         of injury probable or possible in case of accidental or
         intentional misuse.'*-

   • The definition of hazardous substance in ~i3A operates mainly through  the
rubrics 'aisbranded hazardous substance' and 'banned hazardous substar.es',
both of which are prohibited from interstate commerce by 15 USC 1252.   'Mis-
branded hazardous substance' is basically defined as:

         [A] hazardous substance (including a toy, or ether article
         intended for use by children, wnich is a hazardous sub-
         stance, or which bears or contains a hazardous substance in
     '•"- House Report at Z227.

     '•'- 3. Rep. So. 1153, 5cth Cong., Ind Sess.  1C-11  (IJcC).


     £,,.;r.  ~£.:,r,er as to be susceptible cf access by  £  child  to
     •-non;  su:.:: toy or ether article i? entrusted? ir.rer.ced,  cr
     t.iCK.a?sc. in a form suitable, for — S€ in tne household  cr bv
     cr.ilc.rer., if the packaging cr labeling cf such substance 'is
     i:_  "lola-icr. of an applicable regulation. ,  .  or  if  sues.
     suis~;ji:.e,  except as otherwise prcvia.ec. . .  ., fails to
     o-«er  c  label--

               (1)  which states conspicuously (A)  the name  and
          p_;ice  of business of the aanufacturer, packer,  dis-
          tr:_butcr cr seller; (3) the common or usual  name  or
          ::.i« thasical naae ^if there c-e no cocssor.  or  usual
          ziae'/  of the hazardous substance cr of each  conoonent
          •«rn:.ch  contributes substantially to its hazard,  unless
          tn« Secratary by regulation persits or requires the
          us« c: a recognized generic name; (C) -he signal  word.
          'liLN'GZ?.' en substances which are extremely  flazma-
          :;lfi;:(-  corrosive,''7-  or highly toxic;ilj
          :r; the signal word 'WARNING' or 'CA'JTICN*  on all
          ether  hazardous substances; (I) an affiraatiave state-
          sent of the principal hazard o:: hazards,  such as
          'riasrrable', 'Cocbustible', 'Vapor Harzful',  'Causes
          3u:ms' ,  'Absorbed Through Skin! , or similar  wording
          descriptive of the hazard;   (?) precautionary measures
          describing the action to be followed cr avoided,  ex-
          cept wnes modified by regulation cf the Secre-
          tary.  .; (G) instruction, when necessary  or  appro-
          priate,  for first-aid treatment; (K} the  word 'poison'
          for any hazardous substance which is defined as
          'highly toxic'  by subsection (a) of this  section;
          (1)  instructions for handling -2nd  storage  of  packages
          wnicn require special care in handling  or  storage;  arid
          £.T  the stateaent (i) 'Keep out of  the  reach  of chil-
          dren'  or its practical equivalent,  or,  di)  if  the
          article is intended for us.e by children and  is  net  a
          cannec hazardous substance, adequate  directions for
          the  protection of children fros the hazard,  and
'•'-  See Exhibit 5-2 fcr statutory statement  concerning "extremely
; "-  See Exhibit 5-1 fcr definition of  "corrosive."

•l-  See Exhibit 5-2 for definition of  "highly  toxic.


                   (2)  or. which any statements required under  sub-
              paragraph (1) of this paragraph are  located promi-
              nently and are in the English language  in conspicuous
              and legible type in contrast to typography, layout,  or
              color with other printad aatter on the  label.1'-

"Banned hazardous substance" is defined by If 'J3C  1261(q)(l):

         The tera 'banned hazardous substance' means  (A) any  toy,  or
         other article intended for use, by children,  which  is a haz-
         ardous substance, or which bears or contains  a hazardous
         substance in. such manner as to be susceptible of access by
         a child to whom such toy or other article  is  entrustec; or
         '3; any hazardous substance intended, or  packaged  in a fora
         suitable, for use IT. the household, which  the Secretary by
         regulation classifies as a 'banned hazardous  substance' on.
         the basis of a finding that, notwithstanding  such  caution-
         ary labeling as is or aay be required under  this chapter
         for that substance, the degree or nature  cf  the hazard in-
         volved in the presence or use of such substance in house-
         holds is such that the objective of the protection ci  the
         public health and safety can be adequately served  only by
         keeping such substance, when so intended  or  packaged,  cu:
         of trie channels of interstate zcrinerca, ~ ~-

    These two definitions are particularly important  because  15 USC  1153  pro-
hibits the introduction into, delivery for introduction  into, or the  rscaipt
in interstate commerce of either category of substance.11-  Intarstata
commerce has been interpreted rather broadly.  One  case, tor  example,  has he!
that Congress, under  its power to regulate interstate commerce, 337  ever.  rag-.
late wheat consumed on the f am where it is grown  (that  is, wheat  t.-at is
never sold to anyone).1*-  With respect to FK3A, interstate sr.ipsan.z  c^s
been held to be proven if the evidence shews that  the procuct  in  issua was
found in the stata but aan-factured elsewnere  'in  other worcs,  d:.r-?ct  proof ;
the shipment is not necessary).:3-
    '•'-1 15 USC 1251(p).  This definition  also  includes  certain improperly
labeled or packaged household substances  covered  by  the Poison Prevention
 fry regulation)  from  clause  ;'A. .
    -"-  .nis seeder:  a.so  prrni^its  t.ia  acu.
suostancas and certain  other  acts.

           ::.er :ases r.avi  interprets"  tne coverage c: ;.-.;.-..   _n worries •-•
 c;.cl fa.-s wirr-ir. -.13 aef miticr.  of  .-.azardous substance'  unaer "-ISA,'5-
 c.1.- ~c~ :ecu.ir5 laoel.mg as  i  naaaraou s substance under  the  Aat secause i
  n?t rerrularly purchasea by  consigners for household use.   Another casa,
 ,vui™LLL" ;J_     Cases. Cracker  Balls  *"-  fcunc ~cst cracker  balls are a
           -' car.ce , anc are sue j eat  zo ~HSA  aoe_^g rsc'u.;.ra2ier..C.s .   Two c ;.~
           HHA £"clicabls "o  cr;a  substano&s involved. *'-

           t.ie Isdding case on  FrISA is F^rss-ar v. Consumer  ?radu-t Safaiv
",~:.  " lar.. * •  in wman resu-ations  estao_isn—ng stanaaras  rsr  tne .tianurac-
ra  sr.a -c..:^ lir..§ of acst bicycles were challenged.  The  first  set ;f issues
;cussec ::,y the court involved whether the powers cf tne ccEE.ission under
;A  induced the power to establish design, as well as performance, stan-
rc.s.   Th2  court held that it did have such power and, in  addition, that it
jo  r.ea ' ::hs power to maks distinctions betveer. prcducts within a single
        urt next addressed the  issue cf how the Ccasission  tray  regulate
        :,. are. capable of use  by both adults and children.   The  hazardous
        ,:efi":,ricn of 15 'JSC  §1*61 (?) (i; :T") dealing with  alectrical, the
       -•? ;;.iz :.;.', hazaras covers  only toys or other articles  "intenaed f
       	ran." but bicvcles  are  alearlv used bv aaults also.   The court
        T"hs la-'^'-ag-s ana  intent  of the .-.-ISA turn upon  intended
        ,,.se...  [T]he relevant  intent is like that in  tort  law --
        2. result is intended  if  it is a reasonably foreseeable
        result of one's actions.   Incidental use of an iten by
        idults would net  deprive the Ccamission cf jurisdiction to
        regulate the itea under  the 7XSA, and incidental  'use by
        children would not  create suah jursiaiation.

  ls-  25: ?. Supp.  771  (D.C.  Tex.  1966).

  :T-  Vnited States v.  Chalaire,  215 ?. Supp. 54!  (B.C.  La.  1970)

              Determination of such 'intent,' however, is vested in
         the sound discretion of the Commission.  This is particu-
         larly so '[bjetween the [  ] [sic] ends of the spectrum,'
         where ...full-sized bicycles fall.  In view of the evi-
         dence considered by the Commission in this case, we cannot
         conclude that it abused its discretion or acted contrary to
         law in determining that all bicycles except those excluded
         from the regulations are 'intended for use by chil-

    The next issue in front of the District of Columbia Court of Appeals was
the question of whether the power of the Commission under FHSA was limited to
establishing labeling requirements for "bicycles intended for use by adults
and children of sufficient maturity to understand and head the instrue-

         We conclude that the Ccmmission is free in its sound dis-
         cretion to adopt design and performance requirements deal-
         ing with hazards that are susceptible to elimination by
         these means.  The precise outline of the proviso must be
         determined only (1) where the design or performance regula-
         tions would seriously compromise the function of the arti-
         cle regulated, or (2) where the Commission seeks to ban a
         product outright rather than permitting its sale with warn-
         ings.  The Commission has not sought to ban bicycles out-
         right.  A determination that the regulations issued do not
         seriously compromise the function of bicycles underlies the
         decision to promulgate the regulations...  For the present,
         we find that it is not contrary to law for the Commission
         to rely in part upon design and performance rsquirements
         affecting bicycles for persons of sufficient aaturity to
         understand and follow instructions.::j

    The other aajcr issue considered by the court was the level of risk which
the Commission is required to find before the Commission is empowered to
act.:3j  This question arose in the context of whether an article poses a.
mechanical risk.  Such risk exists only when "an unreasonable risk of personal
injury or illness" is presented.:UJ   The court concluded:
    3i- Emphasis in original.  Footnote omitted.  539 F.2d at 785.

    :- 359 F.:d at 736.

    J1* 359 F.ld at 737.

    l:- The issue of unreasonableness of risk was also addressed  in 31av=r
Idaa Company v. Consumer Product Safety Commission, 335 F. Supp. 5c3
^Z.TJ.N.Y. 197-) .   There, the Commission failed to prove that the risk of
injury from plastic toy mouthpieces was unreasonaole.

    3i- 15 rJSC 1251(5 j .

         rr.ers- ..& nr.  indication  in -he language cf -he Act cr  its
         lsg_s l.:t _ve  history  t.iat  the "oscissicr. was bound to
         •leva .cp  a precise,  'bccy count  of actual injuries that  will
         .;e r<;c.'.iz^c :y  each  regulator" ~revision. . .   We conclude
         :.r.£t -';  -recise  statistical  showing is required.

              The Zoczcissicn  is,  however,  permitted, by the FHSA  to
         regu.ate only  aechanical  hazards  that present 'an unreason-
         able ris:-:' cf  consumer  injury.   This aeans that the Coinsis-
         •Jim xus- determine  (1;  that the  risk posed by the hazard
         is an 'in.rsasonaole  one,  and  (1) that there is a sufficient
         :n&ia:s ;;e.veen  the  regulation and  the hazard it is designed
         ic prevent.  The requirement that tae ri^k be 'unreasona-
         :le' necessarily involves a  balancing test like that  fanil-
         lar  .In tcrt  law:  Tne regulation  aay issue if the severity
         ;f the in;ury  that  say  result from the product, factored by
         :ne  likelihood of the injury, offsets the hara the regula-
         tion itself  i=rposas  upon  aanufacturers and consumers.3 ij

    In support ;:f this  last  point, the court citad the legislative history, a
portion '. '. w-ich  provided,  "Before ".he Secretary banned such iteas he would
-,c:;-. -. •„?.: Suez f.actors as  the  utility  cf the object, the degrae  of danger it
pr-iser.ti . ar.d the feasibility of designing out that danger."38-  Balancing
tasti  surh AS that suggested  here  are cosaaon in the iaw.37J

    Nc*.e, howev-ir, that the  reasoning of the court aay not be  applicable to
all r.azar icus sabstances  under THSA.   Only children's articles  posing
rechar.iial and tharaal  hazards under  the statute are based on  the notion of a:
' inreasor.d2le risk" of  injury cr illness,  on which the court placed  its
--apnas »s ^e.rs.  Other FHSA  provisions do not incorporate this  concept anc. so
i~? re-: : s',a,7s;.ril7 subject  to the court's analysis of this issue.

    Ketv.'T.ing ?gain tr  the  statute itself, FHSA provides criminal penalties
-~- vicliting II  USC  1262, ai-  allows  for seizure of misbrar.ded  or banned
.-.azarccus subst.inces,J'-  and  gives the Commission other powers  necessary to
.-.arrv out the Aet.*"-
    3SJ ?octnots  OKirred.   SS9 ?.2d at 788-739.

        559 ?.2d  at  7SS  n.21,  quoting trots 5.  Rep. No.  91-237,  91st Cong.,
       s.  ~  (19 :5 ) .

    ' '' ~'ee»  f""  exansle,  the  Statutory Review of  the  Consuaer  Product
3afetv Act.
     *8- ''  i  ,  li  'CSC 1262 Cpowfer to promulgate  regulations  and sake exezp-
 :icasv,  15  -SC 1270 (e^ac:inaticm.3 and investigations);  15 L'SC 127 L (access to

    In addition, FH3A states that,  in  general,  if  the Comaissicn has adopted a
regulation relating to a hazardous  sucstanca  linear this Act,  then r.c state or
local government osay establish or continue  in affect a regulation designed to
protect against the same risk of  illness  or  injury unlass it  13 identical to
the federal regulation."'-   In certain circumstances,  however,  a stricter
s- s.ta or local regulation is peraiss ibie. l*:-


    FHSA prohibits the entry into interstate  commerce of substancas which are
improperly labeled ("nisfaranded hazardous substances") or banned because of
the hazards they pose to children or to adults  despite proper labeling
("banned hazardous substances").  The  definitions  of tnese phrases are cased
on the Act's definition of "hazardous  susstancs,'1  which is tnerefcr? of cen-
tral iapcrtanca.  A substance is  hazardous  either  as a rasult of regulation
under the Act or because it  is  in one  of  the  categories listed in Exhibit 5-1
and poses the required risk of substantial  personal injury or substantial ill-
ness .
    " :- See '15 'J3CA  1151 aota;  ?ub   1.  No   3e--il3,  ;'.?,  formerly 17  --1"
11, 1360, 7-i. Stat. 23C,  is  anencsd  ?uo.  L.  \c   3'5-"5c,  §-."2.; ,  Ncv.  2, '.:••;-
Stat.  12C5; renumberai  5^.d  anendec  .-uo.  1.  N'c   ? 1-112,  I1-(a .  :":'' 1  , Sov
1 = 69,  23 Stat. 15?,  15C: Pub.  1.  N'


        ,.cr-=.- ~,'-.ze:  five years  zf age were involved  is  sane  two-thirds of the
       5 ", .Z mgesticns cf drugs and pcter.-ia.ily tcxic household products ::e-
pcrto-i ry  "he. national  clearinghouse for poison careers  in  1963. '"-1   During
:?6~ , 22i  children  died fron accidental poisoning.1-   As  stated by -he Koui;a
"-.sscri cr.  the Pciscn  Prevention Packaging Act cf 157C,  "Vaila the total of 325
c.nild caaths fros: this  cause may not appear large in proportion to the 105,000
ingssticr.  mcxdents reported fcr this age group, it  is a  tragic ar.d needless
tell ^,-hic.h dictates that every effort be employed to reduce and,  if possible,
      itt  :-, ''-  The Pciscn Prevention Packaging Act  cf  1S~Q (???A/, *- by
      ..-.i;  :cr "special  packaging to prc-tect children from serious personal
       rr  i«rr.cus illness resulting from handling,  using,  cr ingesting hou;se-
                 •1 "•           r*            •,   ~ -        ^       ,
      ioct;',r.c^s,  '•• was tr.a wcngressiona. =.;rort tc  tms  enc.

         -life  spe-.it-l  packaging of any household substance if it
         finds  tr.at--

               i'i;   the degree or nature of the hazard to  children in
         '.'..;e  availability cf such substance, by reason of its pack-
         r'rir.g,  is  such th^t special packaging is  required to prs-
         ~_.sct  children frosi serious personal injury  or serious ill-
         nass  rss'Jliing frsa handling, using, or  ingesting such sub-
         s'; ar. ess;  'End
     '•- H.?. Ret;.  No.  91-1642, 91st Cong., 2nd  Sess  ,  reprinted in U.S. Code
Cong  and Ad.  News  5226 (1970).
    *-  15  'JSC  §1'*71 et seq.

    !-  :-:.«;.  ?.e~   So.  91-1642, 91st Cong.,  2nd  Sess.,  reorintad in U.S. Coc.e
Co-is,  ar.d  Ad.  News  5326,  5327 (1970).

    s-  The  functions  under ??PA were originally  given to the Secretary of
Heilth. icuoation,  and Welfare, but were  transferred to the Consuaer  Product
Saferv  Co::=issic;s in  1972.  15 "JSC §2079(a).

              (2)  the special packaging to be required by such
         standard is technically feasible, practicable, and appro-
         priate for such substance.7-

"Speciai' packaging" is specifically defined under 15 USC §1471(4):

         The term 'special packaging'  means packaging that is de-
         signed or constractad to be significantly difficult for
         children under five years of age to open or obtain a toxic
         or harmful amount of the substance contained therein within
         a raasonable time and not difficult for normal adults to
         use properly, but does not oean packaging which all such
         children cannot open or obtain a toxic or haraful amount
         vithin a reasonable time.

"Household substance" is also defined in the Act:

         The term 'household substance'  aeans any substance  which
         is customarily produced or distributed for sale for
         consumption or use, or customarily stored, by individuals
         in or about the household and which is--

              (A)  a hazardous substance as that term is defined in
              section 125l(f) of this title [the Federal Hazardous
              Substances Act]; (3) a food, drug, or cosmetic as
              those terms are defined in section 321 of Title 21
              [the Federal Food, Drug, and Cosmetic Act]; or (C) a
              substance intended for use as fuel when stored in a
              portable container and used in the heating, cocking,
              or refrigeration system of a house.1-1

In addition, the Commission is given the authority, but is r.ot required, to
establish special packaging standards, since the statute uses the words "may
establish."  In establishing special packaging standards, the Commission is
required to consider a number of factors:

              (1)  the reasonableness of such standard;
         •,     (2)  available scientific, aedical, and engineering
         data concerning special packaging and concerning childhood
         accidental ingestions, illness, and injury caused by house-
         hold substances;
              (3)  the manufacturing practices of industries affac-
         ted by this Act; and
    r- 15 CSC §1472(a).

    '- 15 USC §1471(2).

                    t.ie  nature  anc UFS cf -he hcuser.cld su.2star.ce. 3-
    r,- c..r :•: i sun  frets  thss r.i'^^.c  ^'*»t, vitn  m*3 sx c it. t icr* ct certain  substances mt^ncec  rcr
 se  as rueli, ':-   ;r.e  subscanc.es regulated :y ???A  are  all defined ir» ariG
;,' s r subject tr rsgulaticr. ur.cer the ~ecer=.l Hazardous  Substances Act
, ~".±L ' "•' ^r the  Federal Food,  Drug, and Cosmetic  Act  (FDCA) . :l-   For ac-
iiticria. -_r.f crrsaMor,  an  these  defm-ticns, the  reader  is  referred to the  sta-
 •;*.:."• r.rievs cr tr.ese  Acts.

    _r s"C'_~;. i..iic;  2e nctec  tr.at 1; «3C 3".~. 2 a__sws  rcr  paci-iagmg cf a
..-usenold substar.cs which does  sot cscpiy vith  established special packaging
 tanc.ard.5 f = r "ha purpose cf zaking such substances available to elderly  or
                            ^MMABIZ FABRICS ACT  --
    Originally anactad in 1953 and subsequently  amended  in  135-,  the Floanable
Fabrics Act (FTA) was revised in 1967. lj  Trie purpose  of this  legislation is
to prohibit interstate commerce in fabrics and wearing apparal  which are so
highly flammable that they ara dangerous when worn by  individuals.

    Authority to issue flammability stancards and associated  regulations was
conferred initially on the Department  of Commerce; this  authority was later
transferred to the Consumer Product Safety Commission  -pen  enactment of tze
Consumer Product Safety Act.

    Regulatory authority is specified  in Section * of  the FTA.  The  Commission
is authorized to institute regulatory  proceedings whenever  it  fines  that a
standard "may be needed to protact the public against  unraascrabla risk of t.ta
occurrence of fira leading to death or personal  injury,  ~-  signficant property
damage."JJ   This language has not beer, reviewed  in any legal  proceedings.

    Authority granted by Section <*'a}  is further defined in Section  -(b;.
That provision describes a -umber of ''findings"  -hat must oe  mace in support
of a flammabilitv regulation:

         *    Regulation "is needed to acecuatelv crotact »r.~
              public against unreasonable risk of the
              occurrence of fire leading to  death, injury,  or
              significant property damage"

         •    Rules must be "reasonable, technologically
              practicable, and appropriate"
         •    atancarcs aust oe  limitec.  to  rabrics ,
              materials, and prccucts whicn have  beer.
              determined to present unraascr,able  risks.

    Furthermore, while  exemptions ara authorized,  they  -say  be  limited utcr. a
finding that the fabric, material, or prccuct  ''is  so nigr.ly flammable as  to aa
dangerous when used by  consumers" as intended.

    The FTA contains other provisions such  as  injunction  anc concemnation
authority ''Section 5) anc specifically prsemots any  inconsistent  staca :r
local laws (.Section 15"^ .
       15 "J3C 11131 et sac.

       Section -'3.,, 15 'JSC §113:; = '

    .zrcugncut tne nineteen  sixties  anc  early nineteen seventies, .numer
statutes were enacted re zininize  -he  dangers to consumers from hazardous
substances and products.  "The Federal  Hazardous  Substasc.es Act of 1960 ,''J
~±e Na:ic:.al Traffic and Motor Vehicle Safety Act of 1566,:-  the- Flaccablei
i-acurs ict .-.sen en en ts  of 1?57,3-  -he  Poison "revencicn Packaging Act  of
19";,"- s::d others addressed specific  hazards. 5-J   In 1967, the National
"cm, ££ io:: en Product Safety was established to  exacine the adequacy of  laws
protecting consumers from unreasonable risks.*-   Despite the statutes
covering specific hazards, the National  Coniaissior. found a general absence:  o:
fecsral action in an area which  it believed required a strong and vigorous;
fece;al presence:

         ?ecig.rzl products safety legislation consists of a series of
         ..sclatec a.-~-3  treating, specific hazards in narrow product
         •:atescr-.as   No Gcverrjr.ent  agency possesses general author-
          t~~ to '"'~~ o—oduc— s wh" ch na rbo — ur "sasonable "**SKS o^ to
         ::ec"j.irp 7n t consumer trocucts  confer"  -c ziiniicus safety
         '•ucr. .iaiited "ederai  authority as  does  exist is scattered
         .snong many agencies.  Jurisdiction over a single category
         of products say be  shared  by  as many as four different
         c.er.art3ents or agencies.   Moreover,  where it exists, Fed-
         *ral procuct safety regulation .is  burdened by unnecessary
         •:roc.ecursl obstacles, circumscribed investigative powers,
         maaequate anci ill-fitting sanctions,  bureaucratic iassi-
         :uae, tis:d acainistration, bargain-baseaent budgets, dis-
         :.crted priorities,  and  nisdirected technical resources. rj
    ;- 1J CSC §1261  at  sec.   See  Statutory Review, pp. 5-1 through 5-15.

    :j 15 USC §:381  et  see.

    :- 15 "iC §11?1  e_:  see.   See  Statutory Review, p. 5-19.

    "- 15 L'SC |I»71  e_t  sec.   S«e  Statutory Review, pp. 5-16 through  5-18.

    !- Ser; A_ts  cited  in  K.R.  Rep.  No.  1153,  91nd Cong., 2nd Sess. 22  (1972)

    E- K.R. Sep. No.  1153,  92nd Cong.,  2nd Sess.  22  (1972).


    To fill this gap, Congress created the Consumer Product  Safety  Comsissicr
(the Commission) in 1972. '•  It was designed to reduce  the estimated  20
million injuries (resulting in 110,000 permanent disabilities  and 20,300
deaths) that were occurring in and around American homes  every year,  and  to
save, as far as possible, the loss of five billion dollars annually that  one
source placed as the cost to the economy of product-related  injuries.'-   The
House Committee Report introduced its discussion of the Consumer Product
Safety Act (C?SA);":i as follows:

          This legislation proposes that the Federal Government
          assume a major role in protecting the consumers from
          unreasonable risks of death, injury, or serious or fre-
          quent illness associated with the use or exposure  to con-
          sumer products.  To carry out that objective, this bill
          would create a new, independent regulatory commission with
          comprehensive authority to take action across the  full
          range of consumer products to reduce or prevent product
          related injuries.  The powers and procedural  requirements
          contained in this legislation, for the most part,  draw and
          improve upon concepts and practices which the Congress has
          previously employed in other safety laws.11-


     The CPSA gives the Commission broad powers, including:   to develop con-
sumer product safety standards,11- to ban hazardous consumer products, ''•
to test consumer products,l*J to conduct research, studies,  and investiga-
tions on the safety of consumer products and improving  such  safety,:s- to
maintain an Injury Information Clearinghouse,LSJ to inspect  factories, vare-
houses, or ether places where consumer products are manufactured or held,17-
to institute court actions against imminently hazardous consumer products,'•*-
    '- 15 USC §2033.

    '- >:.R. Rep. No. 11.33, 92nd Cong., 2nd Sess. 21  (1972).

    11J 13 I'SC §2051 e_c sea.

    ll- H.R. Rep. Mo. 1153, 92nd Ccng., 2nd Sess. 21  (1972).

    -1- 15 USC §2053.

    ;:- 15 USC §2057.

    '•*- 15 USC §205i.

    :!- 15 USC §205-.

              — ss.L  vitr. -ne rncs t. 3 i^nif icEn z  c f "base .   The  £7Jp reach vil 1
-~.v"  r,::.. .;u.~er  t.r:;.cucr  and cr.-?. affair  cf  rr.ese on zr.e Zcnnnssi^r. s
 . j-.-_nx  r~,   '•-:*,-  csverac vill se the  acricr.s rae Cossissisn  car.' cake virh

_:. ;-".•.'   liclu^ec. ii this w^l". De ar.  i^vesiigazisr. cf tr.^s  risk ar.d the tarz
"rsiscns;"."/  rsc.£ss=.ry" as it applies to  star.cards established iir.dsr the C?SA.
~r.-.:- v -.11  ie fell owed by a discussion  of some cf the other  requirements that
• __ :   "Si  L-n:c6ei.  IT.  aazuf act-rsrs .  This review will close  with a brief
iisziss ir,". cr  cue  effect cf t::e "?3A or.  state cr.d local regulation.

I "j r_.~ ;:;.::" cf  '''Icr.Su.~er Product'1 £r.d Juris diet:, or. cf the  3erar.issic~
    A:-  ,-s;:  be  seer.,  the C?SA deals nair.ly with coiis'tiaer products,  which it
I?-drill?  ief-jaea  as:

         Any article,  or coEponer.t part  thereof,  produced or  dis-
         triouti«c.  \i^  .or sa.e to a  consu^ezr «or use in or  arour*\»  a
         sersariijnt or taarpcrary household or resiaence, a school,  in
         recreation,  or otherwise, or  (11)  for the personal use,
         :vr.a.irr:tion o:- eniovaer.t cf a consumer in or around  a  oer-
          rener-t  cr t^sporsry .-ouscno.d  cr  rasi-ence, a scnccl,  in
          recrai:ion,  ci othervise...*3-

Thers ars  a  irizser cf aajcr exaspticns  froa this definition,  nanely, tobs.cco
ir.c tccdcc-  products, actor vehicles  or cotar vehicle equipment,  pesticides
indsr tna  Federal Insecticide, Fungicide,  and Xocenticide Act,2'-  iteas
suo^ect r.c tax under 15 USC §4131"-  or any component thereof,  aircraft smd
c.srtain ^iircrar* ecuionient, certain  woats,  vessels, anc re^atec equmoen*.,
c-igs, cevicss,  and cosaetics as  defined in 21 USC §221(g^,  (h),  and (i)  (the
Fe-.eral "coc,  Drug, and Casaetic  Act),  and food.23J

    S-nc':  the  definition cf "cons-user product" establishes  the  jurisdiction o:
~~e -cT-^.LSsicn,  it has been the subject of a significant aaount of litiga-
•.ic •..,  >i>;.r.y  of the cases dealing  vih  this  issue have interpreted this
c,crinif.':n brcaciv:
            SC §136 et sec.
     "-  r'lsrcis,  revolvers,  firearms  (other than pistols  and revolvers),
shsl.s,  i-nc  cartridges.


         The most unequivocal expression of  congressional  intent to
         be gleaned from the legislative history  of  the  Act  is  that
         "he definition of 'consumer product' be  construed broadly
         to acvanca the Act's articulated purpose cf protecting con-
         sumers from hazardous products.  The report of  the  Senate
         Committee on Commerce, for example, points  out  that,  rather
         than attempting 'to catalogue those items included  •within
         the concept of "consumer product,'" the  Act's drafters
         chose to delineate the concapt by excluding particular
         items from its range.  Similarly, the  report of the House
         Committee on. Interstate and Foreign Commerce observes  that
         the braadth of the definition reflects the  purpose  of  Con-
         grass 'to vest omnibus product safety  authority in  a single
         Federal agency.'  An additional factor in favor of  an
         expansive interpretation of the Act generally  is  th-a Act s
         character as remedial legislation directed  at  a widespread,
         specifically identified threat to the  public safety.-*-

For example, rides in amusement paries have generally been held  to be consumer
products,15- despite the fact that they are  large in size, are  not con-
trolled by consumers, and are not themselves sold to consumers, althougn cr.e
case has reached the opposite conclusion.z'-  Similarly,  another heavily
litigated product, residential aluminum wiring  systems,  has  been held to oe a
consumer product in two cases,17- while two  other cases  question this rul-
    :"- Citations omitted.  Ccr.s-i.-3er
Chance Manufacturing Co., Inc., —1 F.  Supp.  223,  231  (7J.C.  2,2.  1577),  -.-e
first two sentences of which ara quoted in  Robert  K.  3° 11  Zntarprises ,  Inc. v
C?SC ,  N'o. 73-C-iO-C (D.C.N.7J. Ckla. 1930).   See  also  L'nitad  S tat as  v.
Anaconda Co . . -i5 F. Supp. -36, -92 ^D.C.D.C.  19""):   'The plain  vcrcs  :.; tr.e
statute suggest an extremely broad definition  of  consumer  procucts . "

    :'- C?SC v. Chanca Manufacturing  Co..  Inc.,  •*-! F.  Supp   223  ^.C.D  C
19")   ,'the  'Zipper"); The State Fair  ;f Tsxas  v.  United  Statas  C?SC. -31 F.
Supp.   1070  (TJ.C.N'.D. Tex. 1979) (aerial tramway);  Robert :<.  3ell  Intar-
orises , Inc. v. CFSC , Nfc . 79-C-^J-C ^TJ , C .N.7J .  Ckla.  153C"  ,' /en ?.c:l 5k%-
        Walt TJisnev Productions v  "nitad  States  C?SC,  N'o.
discussion of the Disney  case:   'Acuorcmg.y,  tnis  Court will  fr.lcw the =.p-
oarantly scrs thcrougnl'"  rasaarc.".ad  ir.c  settar-raascnec caci^ior. in Chants,
sutccrtad sv the iacisicn in  Stats 7i'_r.'

Kaisar Aluminum anc Chemical  CoTCcnticr. v.  "nitec  St^tas C?SC.  3"- F.2c l"i
       ::. 1?73), cart. tar.iac,  -29  -.5.  331  (1973).

     . cis^* - celling  wita  ar.crr.er  procucr,  virec glass, raised several
     esting issues  relating tc  tne  scope cf  tae Commission's lurisdiction.
      r tzar architectural  glazing  materials,  ar.c in particular wired glass,
          , ..-  « c i° ~*w w «  • .z~iu*. —•— . — -.en  c~  wii£  dor's c.s - mi. - i_cn o i  ccns uiusc
         procTitr' specifies a  req-^ireaer-t  thar rhe procuci must be
          custcmarii?  produced  cr  distributee fcr sale to, cr vise or
          c.cns«is^ti3i^ bv ,  or er."oynent  cf ,  a consumer. ' .  .  .   TA.1
         prccvci 3ust  be   cusccsaril"'  --  act jv.st occasionally --
         •;r-c~c.ad cr distributee  rcr r,he use of cccsumers .  Juris-
          ci:r;cr. coes  net  racuirs  a  snowing t^at a -najcrirv cf
         "rscuct sa.es are tc  consumers, but tiiere zust be a sig-
         nifxc.ant aarketing cf  the product as a distinct article of
              rce fcr  sale to  consumers  or fcr the use of consumers
                the product say be considered as ' oustocarilv '  pro-
Tae court found sufficient aaricetir.g  of  the  architectural glaring materials  in
issue t:: give the Cczsissior.  jurisdiction.
               Vie raised  in  the  vired  glass  case was whether the Commission
               sr the  Secretary  cf  Labor  under the Occupational Safety and
Healtr. .ict  . «£>lay vculd have  authority over  such materials.  The court found
that ' t:ve "res: i^sion acted reasonably  in  setamming that the risk of injury
associated vita architectural glazing  materials could not be reduced  'to  a.
sufficient extent' under  CSIiA and thus required regulation under C?SA."s:-
The raa:,;or. for this conclusion seemed  to  be:

         Under CSHA, which is designed to provide a safe working
         environment,  the Secretary aay net  act directly against a
         manufacturer  of  an  unsafe  product unless that product poses
         a hazard tc the  manufacturer's employees.  Obviously even a
         safe place of manufacture,  organized to protect employees
         fully, may be engaged in the  production of items that will
         be dangerous  to  consumers . 3 lj

Products that Pose an  "Unreasonable Risk  of _ Injury"

    Returning now to the  statute itself,  if  there is an "unreasonable risk cf
injury associated with" a consumer  product,  the Commission may promulgate a
consumer product safety standard to prevent  c;r reduce that risk.33-   15 "J3C
§2CcC^sX-) provides,  "Tae tern  'risk  cf  injury' means a risk of death,
    ~*~ ASG.Industries  v.  CPSC.  593  F.2d 1323 (D.C.  Cir. 1S79), cert.
denied. —- U.S. 36*  (1979).

    ='- Citation omitted.   Ibid,  at  1328.
    3:- Ibid  at  1329.
    --• Joctnste omitted.   Ibid,  at  1329.

    3:- 15 US:  12056.

personal injury, or serious or frequent illness."  A safety standard must
cons is" of any combination of:

         (1)  Requirements as to performance, composition, contents,
              design, construction, finish, or packaging of a con-
              sumer product,  [and]

         (2)  Requirements that a consumer product be marked with or
              accompanied by clear and adequate warnings or instruc-
              tions, or requirements respecting the form of warnings
              or instructions . : "J

To foster innovation and competition,35-  "The requirements of such a stan-
dard Cother than requirements relating to labeling, warnings, or instructions
shall,  whenever feasible, be expressed in tarms of cerformanca require-

    If, however, the Commission finds that

              (1)  a consumer product is being, or will be, distribu-
         ted in commerce and such consumer product presents an un-
         reasonable risk of injury; and

              (2)  no feasible consumer product safety standard
         under this chapter would adequately protect the public from
         the unreasonable risk of iniurv associated with such orcd-
it nay designate such product a "banned hazardous product."  For both a con-
sumer product safety standard and a rule declaring a product to be a banned
hazardous product (both called "consumer product safety rule" or simply "rule"
in the C?SA) , the Commission must consider and sake findings with raspect to:

               (A)  the degree and nature cf the risk of  injury the
          rile is designed to eliminate or reduce;

               (3)  the approximate number of consumer products, or
          types or classes thereof, subject to such rile;
    3i- 15 USC §:C56(a).

    3!- H.R. Rep. No. 1152, 92nd Cong., 2nd 3ess. 22  (19T2;

    Ji- 15 L'SC §2C56(a).

              ,. „'  trie neac ct tne puh_ic  rcr  tne  consuner oroducts
         sur'sct to sucr. rule, anc ths  trocar Is  effect  of sucn ru] ft
         '.:-" -r.e uti.ity, cost, or  avi.i_a:: iliry of  such products to
         3set s-icr. neec; an;

                   any aediis o; acnis'/mg  the  objective of the order
         •«-_ls siiis^zizg acverse effaces  on  oompe'i-isr. or disrup-
         noz "r disloca~icr. of nsnuficturmg  ind  ether conmercial
         rract^cas ==nsistant witr. tns "public  aealzh and safety. :"J

Ir. addit,:-, any such ''rule" ccust be based on.  these  findings:
               ,A,  tr.at tne ru.e  ;,inc.uc.ing  its  eiractive cate; :LS
          reaso^abiy necessary to  elimnate or  reduce an unreasona-
          ble risk, of injury associated vita  such product;

               CB)  that the proaulgaticn  of  the  rule is in the pub-
          lic interest; and
          bar.u'ed hazardous product, tr.at no  feasible  consumer prod-
          uct safety standard under this chapter  would acequareiy
          prctect riie public from the unreasonable  risk of injury
          associated with such product. 35-

    As zay be expected, t.ie question of whether  a rule is "reasonably neces-
   " to =.l:-j2ir.ate cr reduce an unreasonable  risk  of injury" has been central
   scae of the litigation in this area.  The legislative history is quits
                                 which will  be discussed here referred to it:
         It should be noted that the Cotssissicn's  authority to pro-
         mulgate standards under this bill  is  limited to instances
         •where the hazard associated with a consumer product pre-
         sents an unreasonable risk of  death,  injury, or serious or
         frequent illness.  Your cosaittee  has  net included a defi-
         r.itior cf 'unreasonable hazards' within  tnis bill.  Pro-
         rec:icr: against unreascnaOie  risiis  is  central to many
         Fees ;a.l and State safety statutes and  the courts have had
         broad experience in interpreting the term's  meaning and
         application.  It is generally expected that  the
    3I-  15 USC §2C5S(c)(l).

    2S-  15 "JSC §2058 (c) (2).

    ":-  Acua._Slide  'N'  Dive Corporation  v.  CPSC,  569 ~.2d 331 (3th Cir.
   :^: " I. Sear. St.  Sons Co. v. CPSC,  57-. F. 2d 643 (1st Cir.  1973).


         determination of unreasonable hazard -ill  involve  "he
         Commission in balancing -he probability that cha risk will
         result in harm and tne gravity of such harm against  tne
         effect on the product's utility, cost and  availability to
         the consumer.  An unreasonable hazard is clearly one wnich
         can be prevented or reduced, without affecting  the  product's
         utility, cost, or availability:  or one which  the  effect on
         the product's utility, cost or availability is outweighed
         by the naed to protect the public from the hazard
         associated with the product.  There should be  no
         implication, however, that in arriving at  its  determination
         the Commission, would be required to conduct and compiata a
         cast-benefit analysis prior to promulgating standards 'under
         tnis act   Of course, no standard would be expected  to
         impose added costs or inconvenience on the consumer  unlass
         there is reasonable assurance that the frequency or
         severity of injuries or illnesses will be  reduced.''-

Aqua Slide 'M'  Give v. CPSC,"1- perhaps the leading case on the issues
involved here,  stated that:

         The legislative history, and the holdings  of other cases
         decided under similar statutes, do discuss the meaning of
         'unreasonable risk.,' and indicate that tarm is intarralatad
         with the 'reasonably necessary' requirement.   The  necessity
         for the standard depends upon the nature of trie risk, and
         the reasonableness of the risk is a function of the  burden
         a standard would impose on a user of the product.

    The subject matter of Acua Slide 'N' Dive was safety standards  for
swimming pool slides.  The court in that case was working from the propcs •„ tion
that, ''if any part of a standard is not 'reasonably necessary,' tr.en  tr.e wnola
fails the statutory requirement unlass tr.e offending parts  are set  asica.''"'-
After raviawing legislative history, the court looked at how  "unreasonable
risk" was handled in cases under tae Federal Hazardous  Substances Act**-  anc

         In this case, the legislative history specifies the  costs
         to consumers that ara to be considered.  increases in
    4'-- Impaasis added.  H.R. Rep  So.  1152, 92nd  2-ong.,  2r.c  Sess .  22
(1972).  For a ratnar scathing attack or. how the Commission has  attampta:
define ''inraascnabla risk," saa "The Consumer  Procuct  Safaty  3cmmi3Sior.
Search of a Regulatory Pattam," 12 Colum.  J 1. and  3oc.  ?rco. 292   '.-•"

                  -. •  a i q ;';-'- •"• • -  ' 1 ~ a •.
                  — ,  ^^7 ,->.„ *	  .^/,»/.
        See statute" review of that Act.

          ,'icucticns  IT.  trccuct useruinsss .  -.rr'c.icit  •"  this
          -^c.ysis  is  an understanding trxat trie regularise  is  a
          • e.-,5-.-!<;  raetnoc of  racucing me  nsK,.
         i-sc,  an  mtiortar.t  trsdicate to Cccstissicn  action is that
         ccnsuzners  be  unaware of either the severity,  frequency, or
         ..••rys of avciding tae risk.  If consumers hav-e  accurate
         ir-rmatier.,  and still cnocse to incur  tr,e  risk,  t.ier. their
                         ive court rounc sigriricazt  t.-e  races tr.at tr.e
se'/iirity of nsx.  is  great  (parapelegia1* ;  but that this  risk itself is very
s~^ — ' ,2.OQUt en*,  in  10  zi__ior.) .   It was  he*c,:

         Given "..he severity of the injury, however,  and the prece-
         der.t c:'  ether  cases,  ;-  seess likely that  a standard which
         aacually protcised to  raduce the risk without unduly hamper -
         .IT, 5 tne  availaci:. ity  of  the slides cr decreasing their
         .; ____ "-•  could  rer.cer  ;hu. risk  ' unreasonable •    The -ques- .
         tior. t:-.er. is vhatner  tie specific previsions cf the stan-
         dard vhitc.  Aqua Slide challenges have been shown to accctr-
         rlish ::s-:r  task.'s-

                  question, the court pcsed another:

         In veiling the 'reasonable necessity   for the signs, the
         crucial  question  then,  is whether tr.e benefit  has a. reason-
         able relationship to  the disadvantages  the sign requirement
V-t.~ respect  to  the  warning signs and iacaer caain  in issue in tnat case,  tr.e
court held  that  the  Comsissicn had not shown this relationship; there was  not
suif icier.t  support  for the balance it struck between benefits and costs.   The
;-?tst if  :.:.e standard was  upheld.

    This balancing  test approach was also specifically adopted by the court  in
Z_. - _ Be a:-. __&_ Sor.s  Cc.  v.  CFSC,**-  dealing with  safety standards for
natcasocks.   The court stated:
    *'- Citations  oaitted.   >cua Slide  'N'1 Dive  Corpcratjoi: v. C?SC. 369
?.2c. iil,  S3?  (3th Cir.  1ST8).
     "'-  .: T.  ?.:d  6-2 '1st Cir. 19TS).


         Only aftar the axistanca of a hazard and the  likelihood of
         its reduction at a reasonable cos* have beer,  established, by
         the Commission nay is be said ~haz "he raquireaiar.es  are
         'raasonablv necassarv.'
         [A determination of 'raascnabiy necassary'] entails  a
         balancing of the magnitude of the likely reduction in
         hazards to consumers against the increased cost to
         consumers and manufacturers.*5J

In that case, the "gsneral" requirements of the safety standard ware  upheld,
while the "performance" requirements were set aside based en  this balancing

Other Major Provisions of the C?SA

    Returning onca more to the statute, consumer product safety standards  and
the appellation "banned hazardous product" are important because  13 USC  51353
siakes it unlawful to "manufacture for sala, offer for sale, distribute in
commerce,3 3J or import into the United States" any consumer product whicr.
"is act in conformity with an applicable consumer proauct safety  standarc" or
"has been declared a banned hazardous product."  Violations cf this section
say carry severe civil and criminal penalties.5'-

    In addition to these penalties, manufacturers, distributors,  and  retailers
of consumer products are subject to penalties5:-  for failing  to report to
the Cocnission:

         11 information which reasonably supports the conclusion -hat
         such product--

                   (1)  fails to conply with  an applicable consumer
              product safety rule; or

                   (2)  contains a defect which could create  a
              substantial oroduct hazard.  . . .5:-
        Ibid. at 649.

    sa- Defined broadly in 15 USC §;C52(a)(11).

    5 :- 15 USC §2069,' 207C.

    sz- 15 'JSC §2063 (a) (i) and 2C69, 2070.

    !:- 15 rJ3C §2C6i(b).

                _;   a  rrai.ure  to  cocp.y vitr. ar. £pp_icac-_e ccnsuser
         rrocuct sr.faty  rule  w~ic.-. crashes a suostantis.1 r^ss  cf

               ,2;.   a  procuct  defect union Because cf the pattern of
         cefect  the  nunoer of defective products distributed  in
     peruse is _=p errant  net  only for the reporting requirements  just  me-i-
     :.. :.;ui s._ss because  tae  Coa^nissic" a ay crder nctif icaticc  to the  pu:lic,
     actu,rers , distributors,  or  retailers,  and/ or owners cf  the proouct if it
aers— :_ns.is after i nearir.g  that  such a hazard exists and that notification is
necessary to  adequately protect  the public.15-   The Cccnission  nay also
crctr  a manufacturer,  distributor,  or retailer tc take additional action,  if
in the public, interest, such  as  repair, replacenent, or refund  of the  purchase
true  'tie terser: tr »hoai the crder is directed say elect among these
options) s*-   ; a:, lure  to  coap .y  with either type of order may carry stiff

    labeling  rsgulaticns  nay  be  issued -under the authority of either Section 7
cr Section I""*.) of tne C?SA.  T"r.e Section 7 autnority is lizited to consuaer
rroducrr vhith present an unreas enable riik and requires the C?SC to formally
.v.iKe spe, „;'»;. ::i:,nir<.gs .   Section »7,'e", or. the ether hand, is applicable to
.HJT.V ccns".iS3er  rrc—ucts  anc does not recuir'5 the specific findings  listed in
Section '?;c.,  T.: the C?SA .   Section Z"(s) v«.s used in the rule -making on urea-
i=r:3c.lce>.yce  f::ar3 insulation  ^see further Discussion in C?SA regulatory
"av* lew) .

    In closing  the relationship between the C?SA and state  and local
regulations saculd be  discussed.  15 "J3C §1075 provides that state and local
sovernsejics "ay, in general,  establish or continue  in effect standards
relating to consumer product  safety designed to deal with the same risk of
injury a.s an  existing  federal standard only if the  state or  local standard is
io.sttic.^,1 to  the applicable federal standard.  Under certain circuastanc.es,
state  ar.d locil standards whicn  differ fron federal standards will be
    "s'- 1= "3C  §206-(a) .

    !5- 1; CSC  §206-(c).

    %l- 15 "J5C  §206^(d).

    s?- lo USC  §:C68(a)(5)  and 2069, 2070.

    5 i. • .- r z"  ;•)-- =



    Under the C?SA, the Consumer Product Safety Commission  is  given bread
powers to ragulata consumer produces.  The Commission  -.5  autr.cri-ed,  asicr.:
other things, to develop standards for consumer products  arc  to  ban these
products wh^ch can act be mads reasonably safe even with  such  stardarr  .   Tha
major points of controversy which the courts have been  asked  to  settle  are (1}
what is included in the taras "consumer product" and  (2) what  consumer product
safety rales are "reasonably necessary to eliminate or  raduca  ar. unreasonable
risk of injury associated with" a consumer product.  The  judicial raspcr.se has
been to interpret the tera "consumer product" rather broadly  and to employ a
balancing tast in evaluating consumer product safety riles, balancing the
reduction in hazard to the consumer on the one hana  against ;-a  increased
costs and ether disadvantages to consumers and manufacturers  en  the otr.er r.an-c.


-.e  "oniucer ^rccuct  Safe."  Cc=sissisn  ;C?SC) regulates  hazardous sucstan-
.C = -  tr.r =*: statutory  2.urr.cri-ias:

    •     7-jders.l Hazardous  Subscs^icas A--,

    «     P-iscr. ?TSv«inticn  Packaging Ac",

    •     "lacsable Fabrics  Ait,  a."d

    *     Ccnsiiaer Prsc-j.cz  Safety Act.

"ll;r. ^r-g cisc^ssicn  rev^evs the regulations  promulgated under each  Act,
.-is :.v.e -,;.tg'ia used re  c.esignaza substances  for  regulation, ar.d identi-
-re reguictec substances    An overview 3; 3?SC regulatory authority is




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              to acsmister the Federal Hazardous  S (instances  Ac- '.-.-ISA) was
transferrsc iron tae Department cf Health,  iducation,  and Welfare to CPSC in
1.-T.   A1: t.-at tine, certain checicals and  products  were  already designated
.iszarccu': according to the fallowing  four categories.

         •    products declared to be hazardous  substances under
              section 3(a) of tae Act  (16 CF3  1500.12);

         •    strong sensitizers  (16  CF3  1300.13);
              prccucts requiring special  .aoe.ing  unoer section
              3'(b) of the "Act  (16 CFR  1500.14);  and

              banned hazardous substances  (16  CF3  1500.17).
iin-e 1972, CPSC has r.ct substantially  augmented  these lists and has issued
FHSA regulations primarily for products  intended  for use by children (toys,
crios,  rattlas, pacifiers, and bicycles).   ?or  various reasons the Cotzaission
tsncs to regu.bH.te prccucts containing Hazardous suostances  under t.^e Ccnsuiner
Product Safety Act  (CPSA) instead of the 7HSA,  and as a result has not often
seen required to utilize criteria for designating products  containing such
sucstancas under the FHSA.;-  Nevertheless,  C?SC  is  responsible for
regulating the four categories of hazardous  substances that were already
cesigr.atftc or listed in the JK3A regulations  (16  C7R 15CC)  as transferred in
. r"Z,  Exhibit 5--* provides a chronology 01  the regulations and related
       Although C?SC had been receiving  petitions  to regulate products con-
         taining hazardous substances  under  the  FHSA,  it decided instead to
         regulate the products under the Consumer  Product Safety Act.  For
         example, CPSC received petitions  to regulate  consumer patching
         cocpounds containing respirable free-fona asbestos under the FHSA.
         But because the ruleaiaking proceedings  would  be significantly shorter
         and sere public participation would be  allowed under,the CPSA than
         uncer the FliSA, and because CPSA provides additional incentives to
         cotsply in the fora of civil penalties,  CPSC decided to regulate the
         consumer patching compounds under the CPSA (42 F5 63354, December 15,
         IS"").  CPSC adopted this strategy  in two other cases:  lead-based
         taint (-1 •"?, 23637, August  10,  1976) and  chlorcfluorocarbcn
         », .„.,,, •'-_„_ / ' i 7-3 T ; R<~, 7  A-.T- - 1  ~>Q   1 Q7Q >
         », ~ ™- i^JS . *. ^.» .3 '^^^ ~ *^ te^uw/, dw «..A •* •' i :* s • ~ j .

                       7I3ERAL HAZAagous SUBSTANCES ACT
                             REGULATORY CH^CN'CLCC-Y

                    ACTION                                 CITE

         Carbon tatrachloride banned as               16 C73  1500.1
         a hazardous  product by "DA

         Charcoal briquettes regulated                15 C7"R  15CC  I
         under sections  3 (a; and 3 To?                  If 3??.  150C.1
         by TDA.

         Liquid drain cleaners containing             16 C7?.  15CC.1
         sodium and potassium hydroxide
         banned as hazardous products'
         by F3A unless contained in
         child-resistant packaging

         Charcoal briquettes subjected to             15 C7R  15CC.1
         sections 3 (a) and  3(b',  labeling              1= 37?,  15 :'3.1
         requireaents  by FDA

         General-use  asbestos-containing              16 "3.  1500.1
         garments banned as
         hazardous products  bv FDA
         ieir-prassurizec,  procucts

         acnomar banned  as
         hazardous products  oy  C?S
    As indicated by the  regulatr.ry chronology ^n Exhibit 5--,  tr.e T.CS":  rscar.c
cnsmical substance to be  regulated by "?SC uncer the 7-icaril Hazardous  5u:-
stances Act was vinyl chloride  icncaer in 15 7i.   The fact that C?SC  has  cnosan
in racant vaars to ragulate  chemical susstancas  undar ths Coasuner rrocuct
Safety Act (see footnote  1)  instaad of the 7H5A taspers sosewhat the
usefulness of analyzing  the  7HSA ' s criteria frr  casignating suotancas  is
hazardous.  However,  ir.  view of t.ie icora^e Court's racar.c jer.r.ane ruling,
C?SC 3ay find it necessary to  resort to tr.e ler.g';."*" trscest;.r.gs tiar.-azic  :--~

surstancas rules.  If this -rar.c.  cc'/elopa, the 7H5A ' s ces igr.at icn critern  :;r
.lazarccus substances  
    ;•- ;:. atutory  .isr^r.itior.,  z. .tazarious  su2szar.ce  is  a SUES lance or mixture
cf - «_i z.:.-ios i  -^a;  nay causa  ''5v.DS~3r.~i.al personal  injury cr illness."  Vhile
tz...   cri'.eric::  Le£."es  such to be interpreted  '..i.e.,  tne precise a ear: .in g :>f  the
-erz  ' iucstantia..' ^  both C?SC and FDA have  iescnsrra-.ec in various ways tnat
surrstar.cas  ~b.ey designated for regulation may cause  substantial personal
ir/.r*' -"  :llue.ws    Usually regulation was  imposed when exposure to a
P£~ ,.,"". ,.  thfe "HSA regulations provide specific methods for testing toxic
substances,  pr:unary irritants, eye irritants, and flannability.  For other
t*.*->es  of hazards,  C?SC arid FDA relied on  more general evidence provided on  a
case-by-case oasis.   The Federal Register notices of proposed rales did not
eccuser.t t.-.ese  tests to the degree of detail  as provided in the r'KSA
r?gulatisns.  Thus,  there is no way to evaluate the consistency with which
^ssts -*s.re used  to support a need for regulation.

C~£C_>.as Cc-ij_iierable Leeway in Designating a susstance as Hazardous

    CTO;; ~~3l establishes jurisdiction over a particular substance,  it  has  a
f-ir  aascunt cf flexisility in detemining whether a substance  is hazardous  cr
2j..  Asi evidenced by TDA's previous regulatory actions under the  FHSA,  as
lonz  zs there vas  sufficient evidence that  a  substance may cause "substiintial"
_n-u:7 .;r  illness,  :;hen the substance could be declared hazardous.  Although
_:a,5 ...^  _,_ Ui-:i;.ir-. ru^'is as to what constitutes sufficient evidence  c:r
s ;^--".-iT.':-•,;, —•-•jrr,  it 13 tat c.lear that  such rules  are necessary.  Because of


the differing nature of health effaces from exposure to different hazardous
substances and because of the varying degrees to which individuals aay  raact
to a given subszan.ce, it is important chat C?SC be allowed some amour."  of
ragulatory flexibility in declaring a substance- to be hazardous.


    Section 3(a) of the ?HSA authorizes C?SC -to declare as hazardous a
substance or mixture of substances that meets the "hazardous substance"
definition of Section 2(f)(l)(A) of the Act (also restated in 16 CTS.
1500.3(b)).  The Act categorizes hazardous substances very specifically, as
discussed in the statutory review.  However, tarms within the definition of
"hazardous substances", such as "highly toxic", "corrosive", etc., ara  aefined
in 16 cm 1500.3(c).  The definitions and further explanations provide
criteria for C?SC to decide whether to designate a substance as hazardous.

    For example, the tern "highly toxic" refers to any substance which
"produces death within fourteen days in half or more than half of a group of
ten or nora laboratory white rats each weighing between two and three hundred
grams	"  (16 C7R  1500.3(b)(6)).

         •    Thus,  if C?SC possessed data which indicated that
              exposure (also defined in the regulations) to a
              substance produced death within fourteen days in at
              least half of a group of laboratory white rats, then
              the Commission could declare such a substance to be
              highly toxic and thus subject to the labeling
              regulations for hazardous substance under FHSA Section

    The label zust bear the common name of the hazardous substance, the
chemical name of the substance if there is no common name, or the generic r.aae
if permitted by C?SC.  In addition, the word "Danger'1 aust appear en the label
for substances which are extremely flammable, corrosive, or highly toxic.  The
word  "Warning" or "Caution" oust appear on the labels of all other hazardous
substances.  Other labeling requirements under section 16 CF3 1500. 3 (bK-)
involve identifying  the principal hazards and providing precautionary
measures, antidotal  information, handling instructions, and ether important

    The labeling regulations state that a hazardous substance intended, or
packaged in a form suitable, for use in the household or by children will be
tamed "aisbranded"  if it does net bear a label that warns the consumer of
pctentia*. 3.azar^-s pcsec oy tne suostanca.  ~r a cac-arac nazar—ous sucst^nc3
is deemec a aisbranded hazardous substance it is subject to prohibition,
penalties, or seizures under the THSA.
       C?SC determines that  faasible cautionary  labeling cannot  adequately
protect the public from the  hazard posed by the  substance,  it aay dec 1ara a
product to be a "banned hazardous product."


    T"r ~'"IEr.  ri,v	eZicns  l_st " = ^rod-ct. issclarad  tc  oe z. hazardous susstanzs
-nccT seedier.  2s   or  tie Act:   cr.arcca- ir:cur.ttss  and ctnsr ferns of
".aroca.1  _- containers  for retail sale anc  ir.tanaec  for cooKing or heating  '16
~7?.  .:-'  ~- .   "his  product was  declarsc to  se  =  hazardous suos~ar.cs oy the
~o~a"****~a**" -• -'  "-.*-' ~••   ~ducEtiCT,   and W°'l'"a~"s  c  "ood  3"d ~'"*uff Adni"^*s~~"*'*•*-Q^
 rii-.. , -?..i~:.  ".a.:;  o:i^iz.d^ jiir^5-^.czior. ovar  :.aa JliS.-..

    Ir, 1~*C, TZn.  proposed that  charcoal briquettes  be  subject to the labeling
raquirexe.-ts c;f  section  3(a) because when burned, this product is capable of
prr.cue..r.; ''pe::s;:r.s,l  ir.jury and  death to nan  through  reasonably foreseeable
^3^c,l_r.g  anc  .si;"  '25  73  138ST,  Septenber :,  19~C).  72A had re\'ie.wed death
cert^fic=res ,md  ^nfsraation froz ether sourcas which  indicated that at least
37 ;"£t=.l^.;i~2  f:r=i  carscn acncxida poisoning  had  occurred because individuals
usec tr.e  Briquettes  for  cooking  ar heating purposes  indoors, in tents, or in
similar ccnfmec  araas.   Based  on this evidence,  FDA concluded that
:^iiivic.uc.ls vculd be unliksly to bum charcoal  in confined spaces if they knew
it coulc  cause death.   C-n August 11, 1ST"., FDA  issued  a final rules to list
cnarcoal  -riquettes  as  a  hazardous substance  under  section 3(a) of the Ac.t  (26
'-11 "1^' _^:I_J~^rv;I ;E>isrr::;Hs - 16 ITS. sErriON  isoc.is

     7',','  :-i".  "..-;'_rzuus  substance'1 aav accl/ to  any substance or rsixture cf
?•-.„?, tar._ =r "hat  •_.-  a  strong sens it in er.  16 CFR  1JOC . 3(b) (9 )  of the FKSA
rsgu.aticns cefmss strong sensitiner as "a substance which will cause 0:1
ncrtaal living tissue  through an allergic or photocynamic process a
r.'/persansitivity  which becomes evident on reapplication of the saiae
substance." Ceapb-asis added.)  As a hazardous substance, a strong sensitizer
_s su3,;3':.t to tne labeling requirements of the  FKSA, including tnisbranded
h£.zard~u'= substances  and bannec hazardous substances.

    7hs THEA  regulations list five strong sensitizers (see Exhibit 5-5).
Cmce C?SC assuased administrative respcnsibilitjT for the FKSA, no new strong
sen=itiz5.r3 have  been adaed to the list (16 CFR  1500.13).

    In tie si ST. at ing a  substance as a strong sensitizer,  C?SC nust consider  the
rrscuer.cry cf  occurrence  and severity of the reaction, and find that the
substance has a.  significant potential for causing hypers ens it ivity.    (16 CFR
                    SPECIAL LABELING -  16 c:-'~  SECTION i5
    "or  jubsta:;ces  or mixtures of substances  declared to be hazardous,  the
laoeling  requirements of section 2(p)(l) may  be  inadequate to protect  the
general  public  health and safety.  Thus , section 3(b) of the FHSA allows C?SC
to estat'.isn  reasonable variations or additional labeling requirements  as
~.e."e^S£r 7 .  Tha saae criterion for designating  substances as hazardous  under
'..*• Z7~. Sittion  ljOC.3(b)f» applies to  this category.  In addition, the
-ibe.n.s  rsc':i::err.ents of 2(p)(l) sust be deemed  inadequate before C?SC  can
aasign=.ti a hazarcous product as requiring special labeling under secticn 3(b)


































































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      I        °


    The FKSA regulations identify seven products that require special  labeling
including the label content and size where appropriate (16 C7?, 15CC.li).
Exhibit 5-5 lists the seven products.


    In order to be classified as a banned hazardous substance, a product sust
at first meet the 16 C?H 1500.3(b)(4) definition of "hazardous substance."
Beyond that, if the degree and nature of the hazards are such that adequate
cautionary labeling cannot provide adequate protection, then the public health
and safety may be protected by a ban on the substance.

    The FH3A regulations list ten banned hazardous substances (see
Exhibit 5-5) (16 C73 1500.17).  With the exception of self-pressurized
products containing vinyl chloride monomer, certain firework devices,  and
firecrackers, all of the substances on the list wera banned by the FDA.  For
purposes of contrast and comparison, we examine CPSC's and FDA's banr.ir.g
procedures in the following cases:

         •    Self-pressurized products containing vinyl chloride

         •   general-use garments containing asbestos;

         •    Liquid drain cleaners containing sodium and
              potassium hydrochloride; and

         •    Carbon tetrachloride and mixtures containing it.

Self-?rassurized Products Containing Vinyl Chloride Monomer r3?SC'i

    In 157^, C?SC added self-pressurized products containing vinyl cnloride
monomer to FDA's original list of banned hazardous sucstances.  C?SC cased its
decision to classify such products as banned hazardous substances on ~zs
following factors:

         •    Reports of deaths cf several chemical company
              employees who had been exposed to vinyl chloride

         •    Results of animal studies linking vinyl chloride
              acncmer exposure to liver tumors;

         •    Testimony of aedi-al experts ar.d information
              contained in medical literature in support c: the
              position that vinyl chloride ncnomer is associated
              with liver cancer and with other diseases.

              ..•-tcmaticr. containec in an ^ccupationa.  safety  and
              Healtr. Administration notice of proposed  ruiemakir.g
              scplicacle to the use cf vinyl chloride monomer  as  £.n
              _r.grecient cf self-pressurized drug and cosmetic

              Animal studies cited by the Environmental  Protection
              Agency in crcering an emergency suspension of
              pesticide stray rroducts containing vinyl  chloride.
              Results of the studies indicated that  angiosarcoma  of
              the liver had been observed in aice exposed to  low
              concentrations (50 parts per zillion)  cf  vinyl
              cnlorice;  ana

              Exposure studies which indicated that  vinyl chloride
              may be present in the air in concentrations as great
              as iOO parts per million after household  use of
              self-tsressurized containers with vinvl chloride  in  the
    Tr~= tr.', "federal Register notice which summarized  these  findings  (39  ?R
.-.-C.I, August 11  197-), it is apparent that C?SC based  its  designation of
cart a in vinyl c.h.lcri-ie monomer products as banned hazardous  substances  or. two
ma; or c-iteria:   health effects and exposure significance.   The  health
-iffsets  'primarily malignant tumors) were c.ocumented in  animal studies  and
,-ctu=,~ cises indicating a relatively high mortality rate among chemical
;c=.pany earployees exposed to vinyl cnlcride monomer.   C?SC considered these
''r.azarccus substance."  Under section 2(q)(l)(B) of  the  7KSA,  C?SC further
classified vinyl chloride monomer as a "banned hazardous substance" because
tne cautionary labeling required under the act would not be  sufficient to
protect the public healer, and safety from the hazards  associated with exposure
to vmv  en*orice

    The exposure studies also led C?SC to conclude that  the  risk of serious
personal illness from the household use of vinyl chloride monomer produces was
n-it minimal.  The Commission found that the concentrations of  vinyl chloride
in cne air after household use of certain vinyl chloride monomer products may
have been as much as eight times the concentration which induced tumors in

General "se laments Containing Asbestos  (TDA)

    In much tae same procedural pattern followed by  C?SC in  the vinyl chloride
case, F3A proposed to ban garments for general use containing  asbestos because
(1) they presented an unwarranted hazard  of toxiciey and (2)  even caueionary
labelinr would be inadequaee eo protect the public health and  safety from such
hanarzs [2" FR 26-^5, February 18, 1972).

    Certain g2r.Tients constructed from imported  fabric that contained eight
oe.c'jnt ajsestcs, ware being marketed in the "Jnited States.   Upon learning
t;.i; , ~".-i ccnvened an ad hoc ccamitr.ee of five asbestos  toxicity expere.s to


evaluate the health, risks associated wicn the  garments.   The  committee
concluded that the use of asbestos in garments  for  general  use  presented
unwarranted hazards and recommended that appropriate  action be  taker..

    3asad on the committee's findings and tr.e  2 SKA  asbestos cust  standard .'26
73. 222C8, December 7, 1S7I), F3A classified general-use  garnar.ts  containing
asbestos as a banned hazardous sucscance (27 FR  36-o ,  February  13,  1372).

Liquid Drain Cleanars Containing Sodium and Potassium Hydroxide 'T^A'

    In a proposal to ban liquid drain cleaners  containing 10  percent  or xcra
of sodium and potassium hydroxide, F3A cited its own  investigations  into
consumer complaints, death certificate reviews,  and animal  studies  as  =a;cr
sources of information concerning t.ie nazarcs  associated witr. tr.a procuct  2:
T3. 17746, November 13, 1970).  These sources indicated that the liquid tram
cleaners caused a large nuaber of serious injuries  and some deaths  following
accidental ingestion of these solutions by children.   In 1969,  159  accidental
ingestions were reported to "IJA, II rf these cases  required hospitalization.
    Aniaai studies snowed tnat contact vit.i  -sss  t.-an  one  tsaspocr;r-i-  o:  a
strong sodium hydroxide solution produced  ir  less  than three  seconds  full
thickness destruction of the esophagus.  No  antidote would be of  any  value in
such an event.

    72A concluded that despite existing  requirements to labs, the drain
cleaners as poisonous and to provide other cautionary  information,  accidental
ingestion could still occur and result in  tragic  deaths   Because of  tr.e
degree and nature of the hazard involved in  the presence of such  drain
cleaners in or around the housanold, FDA eventually banned -.he product froa
the aar'set.  The FHSA regulations exempt such  liquid drain cleaners  from  t.-.e
ban if they are packaged to prevent  children under  tr.e age of five  free;
gaining access to the container's contents :'16 C??>  1530.17).
    "sad primarily in industrial  applications,  carbcn  tetrachlorice  is  an
extremely toxic substance capable of  causing  extensive dasage  to  tne  liver,
kidneys, lungs, ana heart upon  ingestion,  inhalation or absorption  thrcug.1
skin and mucous membranes.  Ingestion of  three  to  five cc  of  this substance
nay be fatal.  Caa taaspoonful  of carbon  tetrachloride placed  in  an
unventilated 6'xlC'xS' room will  vaccrize  and oroduce  a concentration cf ICC
ppm.  Cne-half pint would produce a concantration  of -,-20  opm VH.IO."  could
prove fatal to most individuals,  iapending on the  length of exposure

    In 1370, 73A proposed to classify as  banned .lazardous  suostancas  laroon

based oart of its decision to ban tne susstanca on evidence introduced  at a
       r.earing that vas held to cst.ermine  the  csgr^a  ~.~  nature  of  hazards
tresantad ov carton tatracn.orice

    .-t "r.t tuc.ic  .learins,  .-~i was inrorae.i t.-.at  consumer:, nave seer,  anc:  v:	
co-.tin-c  ~~ D-s  imposed  un:

    Under Section 3(a) of the Poison Prevention Packaging Act  (PPPA),  C?SC  =27
require special packaging of any "household substance"  if special packaging is
needed to prevent children from gaining access to the substance.  This
provision of the Act is intended to "protect children from  serious  personal
injury or serious illness" resulting from handling, using,  or  ingesting  such
substances.  Regulations aay be issued for hazardous substances  subject  to  the
FHSA as well as food, drugs, and cosmetics (Section 2(2)).

    Most of the regulated substances were designated scon after  the ???A was
passed in 1S70; the evidence of accidental ingestion by children under fiva
years of age around that tiae was undeniably alaming.   As  aany  as  2,C92 cases
of ingestion were reported between 1363 and 1970 to the National Clearinghouse
for Poison Control Centers for just one substance:  turpentine.  Of tnese
ingest ions, 249 haspitalizations were reported.  Two ingestions  rssultad in


    The Consumer Product Safety Cocmission has followed a clear  pattern  in
promulgating special packaging riles for household substances.   Basically,  the
steps involved are:

         *    Identify that the degree or nature of the hazard to
              children (by reason of its packaging) is  such that
              special packaging is required; and

         •    Find that the special packaging to be required by  a
              standard is feasible, practicable, and appropriata.

    In general, the first step has been accomplished by showing  that  children
under five years of age have had access to and ingested household substancas,
and that the accidental ingestion resulted in adverse health effacts.  As evi-
dence of accidental ingestions, C?SC and FDA have used  data froa the  National
Clearinghouse for Poison Control Centers which indicate the nuaber  cf
ingesticns and hospitalizaticns within a given tiae span by type cf suostanca
ingestec*  <*tner sources or inroraation, typica..y oiecica.  -itaraturs, ccnz i~ rr*
the adverse1 health effects of  ingesting such substances.  There  is  no r.ir.i^u=:
nuaber of ingestions or frequency of ingestions below which C?SC can  net take
regulatory action.  There apparently also is no 3inur.ua acverse  effect tnat
must cccur oerore soecia^ packaging 12 consicerec.

    «n tne seconc step, w. 3*** is requ.irsc to rinc tnat tne trocosec  stecia.
packaging is feasible, practicable, and appropriate.  Finding  feasibilit
involved citing tne fact that  a nuaber cf package cesigns seat tne

i ";":."• r.ess  ~ ;7Uirs2Jtnts  cr spG:;ii._ packaging  as  specinsc in iC w.-r>.
",,"C. 1"   Thi.  ,"-3Z'-il£" icr. sats up tne prctocc- for  tasting the ability cf
•: r-_ ; ii- T i.-i—jitg  to  rasi.sc oper.r-ng ry cm_c.rer...

    >r£.-ti-i.:: il:,ry has  meant tnat the speci.il packaging  is adaptable to modem
-as i tr;cur.ti;r,  s.nd asser^oly line •.eonr.iques,  Appropriateness has meant that
trit rac&aicirg  is availacle  in forms tnat are not detrimental to the integrity
if  :re  s;:s£t£™ia and  that do net ir:ter_ere vita  its  storage and use.

    ';~.":;^g;  it  is entitled the Poison Prevention Packaging Act, neither the
Act z'~  its rsg'-iatisas explicitly srsvice a aefmition  cf the tera "pci:;cn."
ln£7.aa- vr.e regulations set up criteria to decide if the substance should be
regulate;:.  T^e  lethocs used to establish tae "serious personal injury or
serious  :,..ness" criterion  are implied in the regulatory provisions for
sxerptit:::^ uncar the  Act.   In orcer to clan an  exemption from the speci.il
pac-:.igi.-,j. requirement,  a petitioner zust follow  certain  guidelines.  These
guicelir.as are  indicative cf the information that C?SC would consider in
Deciding vhich  substances  are subject to regulation  under the ?P?A and v!nch
suostznc6.s are  exespt.

    "or rfxarpls, ir. claiming an sxerption, a petitioner  must justify hew the
.- T.". cr '!.exi.c.i^y anc  trie i.ac£ or acverse dutnar. eicoerience surocrts tne
•t v. ^ ~rct ^ ^ r_.  * r* £.n WJ,MW processes an exempt icn c - a 12,  it considers a petition to
toxics-logical evaluation necessary fcr a particular household  suascance,
indicating the criteria C?SC uses in deciding whether to  regulate  or  exempt  a
substance.  Because C?SC considers the amount cf data r.eecec for a particular
substance to be proportional to tne expected exposure cf  man to that
substance, it has separated the relevant experimental data  requirements  Lite
three subsecticns (16 C7H 1702.9):

         1.   Minimum acute animal toxicity data which must be
              submitted for all petitions;

         2.   Additional data which must be submitted for drug
              products and all other household substances whitr. are
              normally intended to- be used in or on tr.a human  bccy;

         3.   Additional data which should be submitted for
              substances not intended for use in or en the  cunan cr
              animal body.


    C?SC regulates 15 substances or categories of substances -under the ???A  as
shewn in Exhibit 5-6.  The ?ocd and Drug Administration promulgated ???A
regulations for the first eleven substances while ac^ir.istrat .on of the  Act
was under its authority.

    Six of the fifteen substances currently regulated by  C?SC  are  substances
that are intended for oral ingestion in controlled doses.   Improperly
packaged, they present a potential for accidental ingestion cy children  in
dcses that aay be harmful even in amounts normally prescribed  for  adults.  The
remaining substances regulated by C?SG ara either common  household product-
like furniture polish or substances us=c as ingredients in  cenjscn  hcusehc-ld
products.  Improperly pacxaged, t.aese products and suostancas  also pcse
serious potential hazards.

    C?SC,  in its most recant rulemaking activity under  the  ???A.  promulgated
requirements for child-resistant packaging of acetaminophen preparations  on
August 21, 1979 (i4 FR 51211).  The rule applies to  such preparations  that ara
in a dosage form intended for oral administration and that  contain  tore  than
'one gram of acetaminophen in a single package.

    Acetaminophen Rulamaking.  C?SC reviewed medical literature,  injury  data,
anc ceatn certificates before concluding that a special packaging regulation
was needed for acetaminophen in crcer to protect children  incer  fiv*  years cf
age.  Ingest ion cf excessive amounts cf acatamincpr.en can  cause  serious  toxic
affects including liver damage and deterioration cf  liver  function.   Cverdose
cases could prove fatal.  In a response to comments  regarding  its prcpcsac
special packaging requirements fcr acatacinopcen, T?SC  indicated  that  tne
ccnsacuenca of death was not a necessary criterion  fcr  justifying a special
packaging rule ^^- FR 5121-s August 21, 1979).  The  ccrr.men.tar  hac zuesticned
the propriety cf establishing a causal link between  rspcrtac deatns anc

Aspirin and preparations containing  aspirin.

Liquid furniture polish  vnonerr.ulsicn type)  ccr.tair.ing 10
2&rcent -i "~rs cf ~:mer3l seal  oil  and/cr  other  oetrp-  leu
distillate and having visccsiry of  less  than  IOC Sayboit
•universal secor.cs at  IOC"?, stzie"  -s.ac  t.iose packaged in
 rsssurised spray cs
Liquid prepara~_cns -cnrair.ir.g asre  :has  5  percent  by weight
cf nethyi salicylata  (vmtergrean  oil) ,  st'aer  tnan  tho'se
packaged in pressurized spray containers.

Controlled substances sucject to the Drug Abuse ?reven:isn
and Cor.trcl Act cf  19 "C

;'r"wSe'".cli suLsta'";c;s  ccnt-Ti™" scdiua  a;id/sr  tctassi—n
 ^^^^^  ^ ,• ^ w<-> — «- — ..< —~*-  w^.* »v> -- f. A_» £g         ^» , — —  ,r -f — w « »
            Induces  houser.clc  lye,  oven  cleaners,  ana drain
Household substances  in  liquid  farm  containing 1C percent or
mere cf turpentine.

Certain liquid kindling  and/or  illuminating preparations
containing 10 percent or core of  petroleua distillates,  and
having viscosity of  less than 100 Saybolt  universal seconds
at 100°?.

Household substances  in  liquid  form  containing methyl alcohol

Household substances  containing 10%  or more by weight of
sulfuric acid.

Human prescription drugs in oral  dosage fora.

?Iousehold substances  containing 10%  or acre by weight of
ethylene glycal, including peraanent-type  auto antifreeze and
certain automotive bra.^e fluids.

Iron containing drugs.

dietary Supplements  containing  iron.

Liquid paint  solvent preparations containing petroleum
distillates,  benzene,  toluene,  xyiene, or  combinations
tnerecf.  Inciuaes thinners,  removers, brush cleaners for
3?,in:, varnish   lacquer, and  similar surface coating


acetaminophen ingestion.  CPSC responded that "in any event, "here is ample
evidence of non-lethal adverse effects associated wih acetaminophen sufficient
to warrant the special packaging requirement."

    CPSC's promulgation of final rules for child-resistant packaging of
acetaminophen preparations involved the following findings in accordance with
the ???A's requirements:

         •    Serious illness or injury.   From 1969 to 1975 there
              were reported ingestions of acetaminophen-containing
              products among children under five years of age.
              Four-hundred sixty-two of these cases exhibited
              symptoms; 129 of these required hospitaiization.  Two
              of the 6,523 cases resulted in death.  Data from
              another source indicated that for 1976 and 1977, there
              were 901 reported ingestions of acetaminophen-
              containing products; 17 resulted in hospitalization.
              Reports in the medical literature state that acute
              acetaminophen ingestions are highly toxic.   These
              studies, plus the data showing numerous ingestions  lac
              CPSC to conclude that acetaminophen was packaged in
              such a way as to produce potential serious personal
              injury or serious illness in children under five years
              of age.

         *    Technical feasibility, practicability, and
              appropriateness.   CPSC found that acetaminophen is
              marketed in tablets, powders, and capsules-, and in
              various liquid formulations.  For each form of the
              product there are numerous suitable package designs in
              accordance with the poison packaging prevention
              standards (16 CFR 1700.15Cb)).  As a result, special
              packaging requirements for acetaminophen would be
              technically feasible.

    CPSC also found that the proposed requirements were practicable as there
would be no najor supply or procurement problems for the packagers of
acetaminophen products, nor for the manufacturers of chile-resistant
packaging.  Finally, CPSC found that special packaging was appropriate because
packaging is available that would sot be detrimental to the integrity of the
substance and that would not interfere with its storage and -j.se.

    In summary, CPSC based its promulgation of child-resistant packaging
requirements en tne following considerations:

         •    the reasonableness of the standard;

         •    available scientific, sedical, and enginermg data;

         •    the manufacturing practices of industries affactad
              by the standard;  and

         •    the nature and use of acetaminophen.

    r 1 ::i=3c,r 1 = Jerries  Act  (_-.-A)  regulations proculgated by  the Cons-uaaer
rrraucr. Safety Concession  are  cccified at It CFH 1600  (Subchapter D).   The
r = i - . i:. i OTIS prescribe  procedures fcr developing flaamability  standards as well
                 23.cil.ir"" st.anc.ards thecselve.s .
    Th=. procedural  rules  adept  the criteria included  in  the  rrA withou:
furtne:: elabcratica.  Thus,  the Conmissicr. must find  that  a  fiaanabiliry
standard ''xay be needed to prctect the public against unreasonable risj of the
cc~urr=nca of fire  leading to  death or personal injury,  or significant
property manage."   (16 CTTR 16CT.6)  Tiie other statutory  criteria are similarly
i^iil'-C'sci in me r=tg"—laticns.   The rules include no definition of 'unre.iscnable
                  stt^noarcs  are cerm^c ^.cr
incl--.r..mg ilcthing textiles (16 C~R 161C), vinyl plastic  film (16 ~T3. 1611),
•-.~: l::r-jn s slsepware  (16  CFR 1615,  1616), Carpets and  rugs  (16  CTS. 1630,
Ii21\ and nattrasses  and mattress  pads (16 CFR 1632).  These regulations
essc.rt.;.illy prescribe  testing methods and procedures for  flammability
datern.:natio2S,  along  vith  labeling,  record-keeping, and  other  requirements.
The ra::,-latio_ns  do net designate cheaical substances which  a ay  net be
incorpsratad  in  classes of  fasrics  or which aust be  liaited as  additives.
           no  further  consiaeration of these regulations  is required.


    Under the Consumer Produce Safety Ace,  C?SC  regulates  consumer products
containing hazardous substances if the products  present  an unreasonable risk
of injury.  Is the past, unreasonable risks  associated with consumer products
have been brought to CPSC's attention via petitions  submitted by interested
citizens or organisations.  Several of these petitions involved chemical
substances; the remainder concamsd consumer products  vhicn presentee possible
safety hazards unrelated to chemical substances.   C?SC took regulatory action
on the following substance-related petitions:

         •    petition to ban consumer patching  compounds  and
              artificial emberizing materials  containing raspirable
              petition to oan paint  ana  similar  sur race -co at ing
              materials for consumer use that  contain lead  or la ad
              compounds ;

              petition to require  labeling  of  self -pressurized
              consumer products containing  chlorof luorocar'tcns ;  and
                 X~ 1.QH ~ O rSCIl — JTS 3,  S ~ .ilXIClcifc .^  . C ^  C 3 "~ 3l>H
              insulation that releases  formaldehyde  gas.

C?SC action on these products ara discussed separately following a review of
C?SA!3 regulatory provisions for designating  hazardous substances.

    Unlike the Federal Hazardous Substances Act vhic.i was  transferred to C?2C
in 1372, the Consumer Product Safety Act has  been under C?SC ' s  jurisdiction
since its enactment.  Thus, an analysis of C?SA regulations  provides an
opportunity to investigate how an independent regulatory commission interprets
the Act within the context of setting safety  standards z-  banning hazardous
products.  It is important to note that because C?SC regulates  consumer
products as defined in the statutes, it is not the  Commission's
responsibility to designate chemicals per se  for  regulation.  However,  J?SC
23 a v take  and has tak^n  C^SA ? ^~ • T* ^^ -^-^ ^^.i^.c — 3  — ~ a**  ..-.* — -..,  «~a,,,, --'
substances .

    According to the Consumer Procuct Safety  Act  Segu.itions 'li C7?> .11-" 11' ,
C?SC bases its decision on -.•nether or not a consumer product prssenij an
unreasonable risk of injury on the following  factors.

         •il)  Frequency and severity of injuries  associated  vitn i

               "~ ~. s~.~.~*s, , TCT £ -cnsuiijer  procuct ~o cause  cr.ror.ic
               il Ir.ess anc ir.juries vr.ich  co net Deccme evicant until
               scrae  "ue £ft=.r use  --r  exposure to the product.

               Nature of -he risk cr  injury in tanas of its
               r Ciir £.s efec.3 i .„ ity oy trie  consumer .

               5: e-i.il vulnerability  cf  children, elderly,  and
               r.j'r : i.-.appad ccnsusers  to  t.ie riSK cf injury  presented.

                                         trie consumer, taking  into
               ccns: iteration such tr.ings  as the suaber cf  units in
               use.  frequency of use,  and likelihood cf exposure to
               "h,s  idsntif 12- risiv  cf  injur^ curing tvoical  use.
          •['')   Arty additional criteria  which would lead the
               Co:-..:i.Sc icr. to treat  a  petition as high priority natter.

    !;" •_;. .  '!',:•,'„;:: -,^i:  -:„-"* ti^at t csnsu.~er product presents  an unreasonable
 is ^ t! ~  i.ii**«r.'^ ,  ^.  ^u^y '^.w^^'i-^op stE.nc.arwS  c.esi^riec# to reouce  or eliminate  tne
 .ik ~~  -".  "&":' c-cclir--- tne pzocuct to  be  a 'banned hazardous  product" based or.
 £ f i.r.;i;_r, ,;  tr.=.t  t:is product will be  distributed in commerce  and that it pre-
  -ti  a::  ,mr f- H.F . ; _:i 1 e  r^^K "f  injury fcr  which no feasible  consumer product
  f:-tv st.indard oricit  the C?SA would adequately protect  the  public"  (16 CFR
 110 - ~, .  Tne^CI-SA regulations la  not  provieie explicit criteria for
  si~.it i.-£: c:ie::ical sucstances as 'toxic'1, "hazardous",  cr  otherwise subiect
         ____ .rrtericT' ror aasignating  a consumer, crocuct  as  aazaraous is t.iat  a
         : - rjJ!^: J! __ ~L- ^^.^as enable  ris.< c-f injury.

         :!s.ui;irs  ccnsidtrec by tae C?SC in showing that  an  unreasonable risk
          :ae  d..rect^v -TOE the regulations (16 CFR 1110.11).   In cases
         .  hai:r:icu5 products, C?SG uses  this regulation as  a checklist to
         ,.ts  ~..." .i.t aiur.A, efforts.   Much enphasis is placed upon describing the
         ' =;.nd  scvari'y cf injuries associated with a consumer product and  upon
    To support  -ts findings that  a  product presents  an  unreasonable risk,  C?SC
has used  (in  addition to other  evidence. >  epidemic logical  studies cis well  as
an.insal b:.oassa.y cats.  Usually, the results of the studies  have been sumn.ar-
i,r.ac for  ~?5~  :.-. setitions requesting regulatory action.   C?SC relies a |;reat
uial ~-~^-.  pt; it -.oners to convince the Coaunissicn *hat unreasonable risks  are
actually  srssen; ;_istaad of conducting its own research to  substantiate the
clai=.  1!?SC  r,.a,s no* tended to  initiat--, action on its own;  products have  come
up fcr c:.n.= : d»i=ticn primarily  through petitions and consumer complaints.

    Lx.il'" it 5-7 presents for  each substance-related  action  the types of
ir.fc™at..or. use. :••: support cesignation,  including other  agency regulations  or

                                          S3HI3IT 5-7

                                              roa a»amcco3 3g
                                           OTOES  C?SA
                                               Asoestcs    land
Designation as Hazardous
I.  Health Effects Data

    i?idei»ioiogical data  (occupational)       X
    Jpidemiological data  (non-occupational)   X
    Aniaal sioassay data
    Ouer agency regulations or data          X
    Csaulative effects data                   X
    Information contained in petitions        X
    Ot.ler iciantifio stadias
    Consumer ccaplaints

2.  Exposure Considerations

    Significant Zxposure                      x
    Widespread anvironaental pollutant        X

Designation as 3anned aaxardous
1.  Ho tnovn safe taresnold                   X
2.  No adverse economic effects as
      a result of 2an                         'X
3.  No adverse environmental effects
      as rtsult of oan                        X
4.  Availability of aucstitutes               X
S.  No feasible alternative tAat
      would adequately protect puolic
      from onreasonaole :ixx of injury        X

Designation for laoeling aequinraent
1.  Sconoaic Considerations
        Snvironaer.tal Considerations


       •; _ -rr-;;r;-:  sea's  rue unreasonable  risk  criteria, 3?SZ may  promulgate a
       . • ••  -  ,-.-r  • : ••  pr:-c'-c~ .. f "r.c feasible  consumer product  safety s~ar.da.rd
      . -,i.:'.gs to iar.  consumer patching compounds  ar.d artificial  eniberizing
      ,i ..." cc::t::_nin£  restirabls frse-fcrs  asDestss and 1 sad -based  ~aint and
          ?:j...'j:  ?vtj!l]  rec'-iras C?SC to  csr.sicsr the degree  ar.d nature of
      :.- '.•::  ,~r, .  "':  apprcxi.-nate r.usDer  ;f  troaucts to be affactec,  the

      .r.; ;.  l..?t.3  •;.-,&  :ac^=ri ac- = iae.re^  by  CT51 _n banr.i.?.g tne  particular

       t.'lQ 35O::'jT.C5  C.sie,
      .r-;sr.cl, •,  5;  asoescos exocs-re has vet to be determined.
     r -" -''  'rv - £.€Li. '--£-""g - = gu - at irr.s  tcr  procucts .

     r  •: -v  T :  ••adur."  cr eliminate the unreasonable risks of  injury
     _:;i   - \. -: r.cns^ae; rrocuct, C?5C say promulgate rules to  require
      ---    _> .   --  :..'?. t-rc-tt5!.  Ser.tioris  7  and 9 require the C?SC tc
      •„;   - .  ,.     -.  ™r .- .;.,.-ure ;.: :..e  ~.s^  ir.vclvei, tne nuiber  cf products
    :;c- ',   -,«   ..-i.ctad, tne public ~eea  f::r  the product,  and  the economic
    -:..-  .:  ,-'• T:,V    A.l:.ematsl-"-, "he  '*?SC lay promulgate rules requiring any
    ;-i.-  :-'-;   :   -or.s.user proauccs to  jive notice of "perfcraance and technical
      r:.,»e>:  -:r sa.:aty to both purchasers  and  prospective purchasers.  This
     ;;. *."   e',  sutbci '.ty is broaaer tr.an ciia  labeling authority included in
     ;r.^  '  v^= ^ .  because xio finaings  c:  unreasonable risk,  for  exaaple, are
    _r='. .   SiT:i-.-. 17'e, zutr.C'.— ry was  used  as  the basis for issuing varning
    :~*:'r.   i  : :r "r.Ic::r.f:urccarbons as  wel'.  as  tne proposed  labeling rules for
          --~"it  . ".th a hazardous procuct.  C?SC can choose betveer. regulating
    'n .: -«3c-ra;e section on designating hazardous substances  under the
F^'-sre.l I-azardous Substances Act, we  noted that CPSC has  tended to promulgate
r_.~es  -: «fc~  t.ie  Consumer Product Safety Act instead of the  FHSA.   This option
^resents ?. potential source cf confusion as well as a source of duplica::ive
e fforts.

    In '.'"",,  ~.ss Fccc. and Drug Administration declared paint and other similar
surface-ccat ing  materials int.enaed, cr  packaged in a form suitable, for use  in
and aro.nc f:« rouseholc, to be a baaied hazardous product under the Federal
Ho.r.arc.c..3 ic:jtances Act.  The regulation pertained to products in which  the
Lear. -:;•'.*.-,,;t  J»a? :r, excess of 0.6 percent of the total weight  of the contained
3-",:,; :.l  ,ne  ::rocu:" er.terec interstate commerce aft-er  December 21, 1973.   Up
•^rti"  t:.3-: ;,.-".£.. but after December  21, 1S72, the regulated lead content  level

                                    3 -30

    As detailed in this  section  C?SC  issued a proposal under the 3?SA to oar.
paint or other surface coating materials  containing Isad coapcunds in wnicr.
the lead content  is  in excess of 0.06  percent oy weight of c.ie total
nonvolatile content  of the  paint or the weignt of the dried paint fil.t  "-1 FR
23627, August 10, 1976).  C?5C subsequently revoked the FHSA regulations
concerning laac.-ba.sed paint for  products  aanufactured after February 27. 13~3
(15 CF3. 1500.17(6)(iii)).   The resulting  C?SA regulations are presusacly -era
cocprahensive than the FHSA regulations.   Nevertheless, cases of this type ,tay
serve as striking examples  of duplicative efforts in tarns of reviewing
evidence and engaging in the entire regulatory process again.


    As of January 1, 1981,  there are  twelve final cr proposed safety
regulations under the C?SA  (16 C7R  1201 to 1-Ci); five of these regulations
deal with products containing hazardous chemical substances.   These five
regulations involve  four substances:   asbestos,  lead, chlcrof luorccarbcr.s ,  and
urea-fomaldehyde foan insulation.   These regulations are reviewed next.


    3scveen July  1976 and April  1977,  C?SC received three oetiticr.s calling
for regulatory action on certain products containing asbestos under the
Federal Hazardous Suostances Act (see  Ixhioi: 5-i,  Regulatory Chronology
Prior to issuing  a proposal on the  matter. C?5C  detertiinei tr.at it vas in tne
public interest to regulate these products under the C?SA rather tnan uno,er
the FHSA even though general-use garments containing asbestos had been oarmed
•under the FHSA (16 CFR 15C0.17,  -2  FH  633S-).   C?SC adopted this strategy
aainly because the FHSA  r-alezakin§  process (governed by Section 713(e^ of the
Federal Food, Drug,  and  Cosmetic Act)  would have involved lengtny hearings and
".nnecassary delays in promulgating  a  regulation.  Although Section 9'a,(2)  of
the C?SA requires the Conrcissicr. to provice an opportunity for oral presenta-
tion cr coaaents  before  issuing  a rule, the oral presentation is informal s.~d
ncnadversarial, and  is less likely  to  involve extensive celays.   Anctner
reason vhy C?SC opted for regulating  the  asoestos products ur.ier tna C?5A
instead of the FHSA  is because the  C?SA provides for civil penalties vhic;:
night serve as an added  incentive to  cc-m'sly with a rule.
-etining the Products

    The regulations  define  asbestos  as  "a group of aineral fibers composed of
hydrated silicates,  oxygen,  hydrogen,  and other eleaents sucn as sociua, iron.
sagr.esiusi, and  calciua  in diverse  cocoinations and are:  Aniosita, chrvsotile,

asbestos.''  Free-fort:  asbestos  is  'tr.at wnicn is not oo'ur.d, or ctnarvrse
lcc:cec-in to a  product  by rasir.s cr  ctr.er bonding agenii, cr vn:.en iir. riic.il".'
   :xe i

    C?SC declared  the  following oroduct£ containing frea-forr. asoastcs to be
b anned h an a—to us o^oducts "~da*" ~ ~ &  "^<;---  *—T-^ , ;^*a — ^5—----^^- -^«,«r. .^--  .-^^  —

zatanals used  in  firaolaces to simulate lira ertoers rr.c asr. ,'..- Z~~.  12C- in.-.

       _;  . - *i™  " ^  _/£F ^Ztl — '" £ AS £ £5 ~ OS  r"T ~ ~UC -.!•  2.S r.£.n3.r — OUS

       ::r~er  t:  aesirna~a a product  as  hazardous .  CPSC must  determine r;:a~ the
        r.r«s = n -s  H^ -^ire.-iscnai Is r:.s*  of  i.:.,;urrv .   The risks  associ.az.ec wi-h
       "  7^ .I~ Zn .L^-A" CC™OO wJH.G.w &r/.d c.r"^ .1 IT ^ C.l.£ . 2HlDG.r i_Z,^-Tlt u!2-* €iIT — 3. — S  »-Ctl »&JL*1^»I1£
     n •= friers  and -he prcDabilitv  of  i^c.-^rrir.g -hese health  effecrs.  Taese
     cl'5s  ir  :"irn era a rjaczion of o~her fac.rsrs such as
     n.c " i~ •. cr.i   ? i", exposure.
                               r.se because  the asbestos in  cocsuaer pa- ihing
-.^rr- r.u-. '.s  .ir.c.  irtificia'. eriseri^isg za~srials are capable cf  becscmg airscrne
cT.d  •T.U.-; res;-irs.3le.   M^jcir.5 cf ccusuxer  patching sscpouads prior to
ippliia-ic.1, sanding  of tse product after it is dried, and  cleanup after
applicatisn  rs lease asbestos fibers that  can be inhaled.  Asbestos fibers  in
esbers tind as;:,  can ce moved about the  household by ordinary air currents.

     Substantial evidence has indicated that the inhalation  cf asbestos  fibers
is, ansociatec :;:.t;-. the risk of cancar.   Specifically, the most common diseases
l-r-kac ~o  ii'v^s-cs exposure are asbestosis. bronchogenic carcinoaa, aesa-
"..• .:'__ ;i ..  a;..J  -.r:,c.sr  cf ii.a .Ttonach, coloc, a^nd rectua.  These diseases
                            cf potential  health effects from exposure to free-'

     I\v '::-:.". -r. ;• : :rp-:unc:e': v'ren exposure :.s ta^er.  into consideration.   It
rs;  .it:  '-••'•,-».  r-ic-sri^red tnr.t continuous  and niga. levels of occupational
iripc-., pir-i ".c  a^oestss  could laad to diseases.  Mo"e recent data indicate  that
eve- lew levels s: exposure ts asbestos,  as is non-occupational settings,  or
brief cr mtersittent exposures to higher levels, can also  lead to cancer.
The  cnl7 kiiova  .study  of consumer exposure to asbestos in spackli^ig and  ether
: s " th iz i ccspcunds indicated that procuct users and other household aesbers
vere a.xocse:-. tc significant concantrations  of asbestos.  The  presence :n the
ho use he- Id  o: persons, such as children,  who may be particularly vulnerable to
-.arc in? sens  vould ennance the risk of  asoestos exposure.

     ~?SC te-.'i'wec, inforaation contained in numerous studies (i2 F?. 387S>9 ,  July
«:• ,  15""!',  prcciies £  cstrplete list of  references) before concluding thiLt the
seric;u;,ners  cf  ;he :.n;u::ry and the potential for consumer exposure balanced
ag-iir.f: ~he  cists of  regulatory action supported a finding  of unreasonable
ris^ o:: injury.  Based on this -determination, C?SC treated  consumer patching
cozpcunci)  ana  artificial eaberizmg materials containing respirable frue-fom
asbest:. s as  canned hazardous products.

                   esisnate Asbestos Products as Banned Hazardous Products
    A second,  although not necessarily discrete, consideration for CPSC  in
dasi.rn.::,ticg  products as banned hazardous products is whether or not any
feasible  standard under the CPSA  can  adequately protect  the  public from  an
•jr.r;_s:.njole risk cf injury.  As  CPSC reviewed the available information on
~~;Za.t^.::.s  ri?«s.  it discovered some  uncertainties about the health effects oi

asbestos.  For example, minimal exposure levels required  to  cause  disease  are
not known.  Furthermore, the actual risk of adverse health effects  may  be
understated as malignancies can arise twenty years, or acre after exposure  ar.d
many more cases of illness may still arise.

    Because there is no known threshold level below which exposure  to
respirable free-fora asbestos would be considered safe, C?SC concluded  that  no
feasible standard under C?SA could adequately protect the public fron risks
and that a ban on consumer patching compounds and artificial emberizing
materials containing respirable free-form asbestos would  be  necessary.

                                 EXHIBIT 3-3

                              AS3ESTOS PRODUCTS
                            REGULATORY CH5CNOLCGY

        7-15-76        Natural Resources Defense Council
                       and Consumers Union petitioned C?SC
                       under FHSA

         2-9-77        Public Citizens Health Research Group
                       petitioned C?SC under FHSA
        4-15-77        Private consumer and Environmental
                       Defense Fund joined in petitioning

        8-29-77        Proposed to ban respirable free-      42 FR  23752
                       form asbestos in certain consumer
                       patching compounds and artificial
                       emberizing materials

       12-15-77        C?SC issued final rule to ban         42 FR  62254
                       certain products containing
                       respirable frse-forn asbestos


    C?SC recently declared paint and other consumer products ior.taining sera
than a safe level of lead to be banned hazardous products.  C?SC's  involvemer
with lead-based paint and other articles began with a  1972 laad-Based  Paint
Poisoning Prevention Act (L3PPPA) directive to the Chairman of C?SC  to =scar-
tain a safe level of lead in residential paint procucts.  Sased en  animal
studies conducted for the Commission, CPSC found a 0.5 percent level cf laao
in paint to be safa.  This level was then incorporated in regulations  ccr.csrr
ing lead-based paint, including CPSC's Federal Hazardous Substances  Act


                                 Z.3c percent, cut not over  0.5  percent,  was
                 C vas  unaoie  to determine inat paint containing  over C . 06%
                -r.t  containing more tr.ar. >1 06 p-arcenc lead  became the basis
                  Ir • - ,  C.-b^  prapesec to 3an _eac-based paint  and other
                  g  lead-based  paint that fell under the jursidicticn of the
                  afety  Act  (-3 ~3 2363T).  (See Exhibit 5-9,  Regulatory
                  p::or=i.._ ptrtainec to consumer products  cor.tai:iing acre than
                  ".eat as  uater=inec ir. tbs 13FPPA proceedings.   C?SC ij.suec a
                 ins;  :r.esa urccucts to be sanned b.asardou.s troducts  on
   T'.-.e ian applies  to  "paint  or other similar surface coating material:;
'.*v. - .1 ~^*, .™/^ »^w' or  .eac. co£?rjc^ncs anci in vnic«i tne Xead content (.ca^cuiiited as
%•-.-; «e:a.  is i.i excess  of  C.06 percent 07 weight of the total nonvolatile
c:r.=-: cr ;.-a paint or t.-e  weight of tne dried paint film"  (16 CT3 13C3.2).

   l:,:.r r prod-rt-  Declared  as banned hacardsus products are:

         '.   Trv;  jji'.d  otner articles intended for use by children
             -'.at  ;aar -eao,* containing paint, and

         ',?,,  F-^rr-iture articles (except for metal furniture)  for
             ccinsviner  usa  that "sear lead- containing paint.

--'*'-.-  "- s ed ;o Designate  Lead-Based ? air t Products as Hazardous
           d tne unreasonable risk of in jury criterion to  designate products
 :.ta_;_r£ lead-based  paint  as hazardous .   Lead-based paint is  the main source
f ledc pcijcr.ing in children (-2 ?R iilSS), especially those with pica (a
 r.dit: 2n evolving the  repetitive ingest ion of nonfood substances), who
 ti.'-tiZ'SS e:i.t leaa- containing paint or peelings from toys or furniture.  The
r;fc,;-s ~; such poisoning  include hyperactivity , slowed learning ability,
                      ana ever, deatn.
   In issuing the  final  rule to ban the lead -containing products,  C?SC noted
 at tne seriousness  of the lead poisoning problem was well  documented in a
 ticnal Acadaoy  of Sciences report.

„ i:~r:.2 '.."sej tc  Jesizr.ate  Lead-Based Paint Products as Banned Hazardous
   r?::C bassi  its  decision to designate she products  containing lead-based
 inr, is banned hazardous  products on the lack of any  feasible safety sitandard
 a- v*"ulc. adequately  protect the public froo unreasonable  risks associated
 ;:•. t.<,ir.: ccr.taining  nore than 0.06 percent lead.  CPSC  stated that it was
: •: .v-'re :f  a  -fechn^-logically feasible procedure for  detoxifying a hazardous
;ar.ti:v "f  leas  when  present in oaint (42 ~R ^^199).


    In banning paint and -he articles containing paint: with  acre  than C. 36
percent lead, C?SC also considered economic  factors  such  as  the availability
of substitutes and whether or not "he ban's  impact on the utility,  cost,  and
availability of paints, ate., would cut*fai~h tne need to  protect  the  publ_c.
See 15 CTR 1105.9(e).
                                 EXHIBIT 5-9

                              LZAD-BASED PAINT
                            RZGTJLATCRY CH3CNCLCGY

        2-2--7S        Consumers Union petitioned  C?SC

        3-10-76        C?SC proposed to ban paint  and other     il  7R 3262"
                       articles under its jurisdiction  that
                       contain more than a safe  level of

       12-16-76        C?SC held aarings on issue               -2  7R 9--C-

         9-1-77        C?SC issued final rule to establish
                       lead containing paint and certain
                       consumer products bearing lead-
                       containing paint as bannec  hazardous

    CPSC's involvement with chlorofluorocarocns  CC7C}  began  vith  a 19"-
petition froa the Natural Resources Defense  Council  that  requested, a oar. on
all aerosol products containing certain C7J  compounds  ''see Exhibit 5-12.
Regulatory Chronology}.  The petition  alleged  that the release  of tr.ese
coapcunds into the atacsphere causes, depletion of trie  ozone  layer and couli
ultiaataly lead to adverse health erects.  C?SC  denied the petition because cf
a lack of sufficient information

    In 1975 and 1976, C?SC receives additional petitions  related  to C7C
procellants.  In Ncvember 1975, C?SC preliminarily found  that  aerosol prccucts
containing CFC propellants presented an unreasonable risk of injury.   The
finding eventually led C?SC to prooose a  rule  to regulate C7Cs  in consumer
products (-2 7R 213C7) .

    Initially, C?SC had  intandec to "rcpcse  that the prosuots  oe  cesignatei is
oannec nacarcous products, scwever  tne  invironaenta.  protection .igency s
authority under TSCA to  regulate non-essential  uses of  certain C7C  propel l.ir.ts
altered this strategy.   An EPA proposed ban  on  the products  voulc navs
randarsc CPSC action unnecessary.   Although  C?SC  decizad against a  ban 'indar
Section 3 of C?SA,  it  found tnat soce  regulator"*  action -n  the orocucts vas

recuinr.i;  -am ins laoels on aerosol  products cor. taming C"C prcpellar.ts  in
    >cr tne  purposes of the regulation (16 Z: s. 1^01),  chlorcf luorocarbcr.  means
"any fully ha.ogenated ch.lsrcfluoroalk.ane" and propellani aear.s "a  l^quisfiec
or -r:fs: =£.-ec  s^3s «~ a c,or.~i^ner,  where a purpose cr  -he liquefied  cr  C::E-
p.o-:o.i-, ga=  :s  '. c ,:.xrel 2a.ar_al  rras the ccctainer."   The labeling
:'-••-,_;,-?a.£r;  ct:,-" i*--s •*.; ''self-pressurized products oonraizing fully  halcsar-ated
               "•" r?~. ?.
    C?3"  D3.se,:.  : t.T finding that  aeroscl products using C?C propellants
present ad  ar..  -nreiisnable risk cf  injury on information contained  in  petitions
ar.c sc-.";=ti;::.;;  reports.  .nese petitions ana reports  mcicatac that  t.ie
•or--:-: .;>  __•  u.ie:.ti-n say mil rest lv pose serious  adverse health effects.   In
~a.~~. -.;- -ar.  Cl'Ci. rtleasec into the  atacsphere may oause depletion cf the
s^" r-T^L 'vf.£r.-«c  c"v?ri€* vmcz^ is ^rnocrtant in prctectm^  tne eartn »roc  tne  3un s
jrrrtvs1. e ult.ra' lolet r.= y; .  Tr.is depletion :^L turn could lead to a  si£-
...:i;'i.r:  :r,-r.-. i.- = e ;n s> :.r. cancer.   Ar-cthe:r possible consequence cf ozore
IS'Z'.'i',", T_  l.s   l^JT-fctiC. C~.dT.2S.

    je ;,a-j.i a-  C?'_,3 r.ac sear, widely  used as p rope Hants  in c. r.unber of  coiLSuaer
:.ercs-.l pro-;u:ti ?.rd oecausa use  of the products  resulted in the release  cf
C~Cs ir:to tie  ctacsphere, ^?SC determined that regulatory action was necessary
is prs*:.ec:  t:.e  public from the unreasonable risk  cf injury associated with the
                                   EXHIBIT 5
                             REGULATORY CHRONOLOGY

        H-2C-"-        Natural  Resources Defense Council
                        petitioned CPSC

         5-::D-"I        CPSC denied petition on  the  grounds
                        that sufficient information  was

        12-23-73        CPSC received more petitions and
       •>  2-2^-~s        information


                                 EXHIBIT 5-10

                            REGULATORY CHRONOLOGY

       10-14-76        Chemical Specialties Manufacturers
                       Association, Inc., petitioned C?SC
                       to issue a labeling rule for aerosol
                       products with certain CFC propellants

        4-29-77        C?SC proposed a rule to regulate         42  FR  213G7
                       CFCs in certain consumer products

        3-24-77        C?SC issued final rule   '                42  F3  42730

    CPSC's involvement with urea-formaldehyde (U.F.)  foam  insulation  provides
an inrerssting example of regulatory response in the  waka  of numerous  consumer
complaints about a product.  In the fall of  1976, C?SC  received  a petition
about the possible adverse health affects associated  with  the  ralaase  of  for-
maldehyde gas from U.F. foam insulation (see Exhibit  5-11, Regulatory  Chronol-
ogy).  It was not until spring 1979 when C?SC had received 195 ir.cidar.ts  cf
health problems that it began to undertake further investigations ir.to the
matter.   3y March 1980 CPSC reportedly received over  l.COO consumer ccnp-iair.ts
about U.F. foao insulation, and in June 1980, it issued a  proposal to  regulate
the sale of the product to consumers (45 FR  39434) by requiring  manufacturers
to include information en the sales contract concerning the risk cf acute
illness caused by the release of formaldehyde gas.  In  February  1951,  after
receiving the rapcrt of a faderal panel established to  assess  the risk of
chronic injury associated with formaldehyde, the CPSC proposed a bar.  cf the

Defining the Product.

    The proposed definition of the product to be regulated is  as follows:

         "Urea-formaldehyde (U.F.) foam insulation",  also  rafarrad
         to as formaldehyde-based foam insulation, or
         foamed-in-place insulation, is a cellular plastic thermal
         insulation material which contains  as  a component chemical
         formaldehyde, formaldehyde derivatives, or any ctr.ar
         chemical from which fcrmalder.yde can be ralaasad.  The
         produce is manufactured at the jcbsita by mixing  two  licuid
         chemicals -- urea-formaldehyde based (or urea-based)  rasir.
         and a foaming agent-- and, generally, pressurized air,
         through a foaming equipment systam.  The resultant mix  has
         a shaving cream-lika consistency and is usually pumped
         through ralatively small holes ir.to the vails  of  standing
         structures.   After it is in the wall,  the product cures ar.d
         becomes firm or self-supporting.

     .r.i  rd-.ic  criterion  «?£,. usec in designating  '-'.?.  foam insulation  a:;  a
 Hrsr.;v.j tr~cuct  was  the unreasonable ris:< of  injury  caused by tne release  of
 "T.il-.  -••• . - 3;^    I.t  addition to consumer complaints,  C?SC based its  p'ropcsal
 .. r^;-.i"-  ..„•',  isar  ._r..su. itic:: on various tnedicai  and scientific reports.
 •;e rvpsrt,  a  National Ataceny cf Sciences stuay  for C?SC,  involved an
 i.r.-.i.-'.'.r.: cf  vhather  there  is a to.lerable level  cf. formaldehyde in the  air  of
 :n-i.    ir.-:.-.r.ft r  •s;ucy, conducted oy the Chemical  Industry Institute for
 ,::.-.1 L .'£-,  v«.pv:rter. pr&lusmary test results showing  that formaldehyde  causes
 iuc-,r  j_r. some:  laboratory animals.   C?SC considered  a  report prepared  by  a
 =-.:er:i;  pantl  evaluating the chronic toxicity of  formaldehyde.  The panel
 :r.c;ucic mat  foraalcenyde  should be presumed  to pose a carcinogenic  risk to
 ;san= .  CPi'J  also took  into account actions taken by  state and other  federal
 .^3r,~.£ii wi'it-  r«s*^act  to ^..r.  roam msu^a^.ion.

    "rc:r. tnese  sources C?SC  learned that formaldehyde  released from insulation
 an cause serious  illness in hunans.   Among the more consaon short-term
 ^actions are  eye,  ncsej  and throat irritations,  coughing,  shortness of
 re^tn.  sV,:.n irritation,  nausea, headaches, and dizziness.   The forsialc.ehyde
 ,.„•=.-.it  icr.  '..:ad to 10re serious reactions for  oersons with respiratory
    C?S" /ol.owfed  up  on some of the consumer  complaints with in-depth
;—• -ss- .i'.~-~~~s  --'  document the types of reactions  caused by exposure to
f::—dl.:.er.vc?  gas and  also to measure the amount  of formaldehyde gas released
i-.: - tie ho;aes   In air sample measurements,  3PSC  investigators utilized  the
-• -.'.ictii,. 1.-s~'.'-".'* for Occupational Safety and Health procedure for ai.r
: ; ,lcc.:,...ou arc  .aboratory analysis.

    insthe:  :riterion C?SC used in designating the foam insulation as  a
:.._r.crd:;us product  vas the amount and duration of exposure to formaldehyde
,;ij    ;• '.::v-rsity cf Iowa quantitative study on the release of the gas  from
"_ . ?.  ; :;am insulation  and technical data presented  by an expert at the
'-,;-._vsr', ity ;::' '-.asnington supported the  following (45 PR 39426):

         'J 7   toar:: insulation will release; a  measurable amount of
         formalcenyae after it is manufactured;  and

    :,'..*  Tie  Insulation may release formaldehyde gas into the home
         fcr  az indefinite period of time after  installation.


                          EXHIBIT 5-11

                     U.7.  FOAM INSULATION
                     REGULATORY CHRONOLOGY

LO-20-76         Metropolitan Denver District Attorney'
                Consumer Office petitioned C?SC to
                develop safety standards for certain
                types of home insulation

 3-12-77         C?SC held public hearing to discuss
                issues raised by petition

 6-10-73         C?SC published proposed rule to
                notify purchasers of 0.?.  foaa
                insulation of the possible adverse
                health effects associated with the
                release of formaldehyde gas

 12-3-79         C?SC announced it vould hold puolic
                hearings to obtain more information
                on the safety of formaldehyde gas
                relaased frots 'J F  foam insulation


    The following reviews discuss statutes and regulations  adainistarad by
NRG.  The statutory review discusses the Atomic Energy Act  of  195*,  the
regulatory review covers regulations promulgated under the  Act.

    The legal review and regulatory analyses that follow do not necessarily
represent the official position of N~RC.  Moreover, this saterial has not been
officially endorsed by the EPA as its understanding of NEC's authority.  The
contractor, ICF Incorporated, and its subcontractor, Lawrence  V. 3ierlein,
P.C., are solely responsible for all analyses and interpretations.

    The Atomic Energy Act is directed to  "he  safe development of nuclear power
and the uses of atomic anergy.  The scope of  activity conducted under "he
statuf-i is somewhat linitd by definitions of  the nateriais to be regulated.
•'Ithcu rh discrst:.on to regulate these materials  is broad,  the authority to
cesi^ru-i.ri sateriiis within the definitions  is  cumbersome and inflexible..
    Section 2012 contains Congressional  findings,  including (1)  The
processing and utilization or source, byproduct,  and special nuclear mc.tarial
mist be. rag-dated in the national  interest  and in order to provide for the
coaascn dafanse and security and to protect  the health and safety of the
j'ii.ic," and (2? "Source and special nuclear  material production facilities,
ind utilization facilities are affected  with  the  public interest, and
regulation by the United States of the production and utilisation of atomic
•ia?.r^7 and of the facilities used  in connection therewith is necessary in the
-JT ir:i.Ll interest LO assure the common defense and security and to protect the
li'i..-. 1" ". in^ safatv oi the oublic."

    T -, r.ii~ "atcnic energy" is the statute aeans all forms of energy -.released
,_n ~.'~<^ :^"^~.-~. of unclear fission or nuclear transformation.  "Byproduci:
-•*,:*•:  '". ' '.curtd material," and  "special  nuclear material" are defined  in
    T^is tart, ''byproduct aatarial'1 means  (1)  any radioactive aatariai  (.ixcept
•special tuclsar aatarial) yielded in  or  made radioactive by exposure  to  the
radi-Ltian :_neident to the process of  producing or utilizing special nuclear
ta-.arial, and  (2} the tailings or wastes produced by the extraction or
.one .'" : rat ion of uranium or thorium from any ore processed primarily  f.:r its
icnt^s ;-3.t3r..a_ content..

    The "2-rr "source aatarial" means  (1) uranium, thorium, or any other
^itar'i.. '-r.i.:h is determined by  the Commission, pursuant to the provisions  of
Sect ic~ 41  f-2 USC 2091) to be a source  material; or (2) orss containing one
or acre if  the fcragoing materials, in such  concentration as the Commission
i:ay bsi regulition determine from time to time.

    Trie  ;arm "special nuclear material"  means (1) plutonium, uranium  enriches
in the isois'De 223 or in the isotope  22.3,  and any other aatarial which  the
Comrcission, 3ursuant to the provisions of Section 31 (*2 rJSC 2271), datarmmes
zo be spec-al  nuclear aatarial,  out does not include source material; or (2)
2n~ material arf.f icially enriched by any of the foregoing, but coes  not
induce scui--.a aatarial.
                  5T  S SC

    Sec-ion 2091, granting the Commission authority to determine what
ccnstitutas source material, requires a finding that the material is essential
co the production of special nuclear material and that the determination is in
the interest of the common defense and security, and that the President has
agreed in writing.  Section 2071 says that, before making the determination
that something is special nuclear material, the Commission must find that tr.e
material is capable of releasing substantial quantities of atomic energy and
must find that such a determination is in the interest of the common defense
and security and that the President agrees.  These determinations in turn must
be submitted to Congress before they nay become effective.

    The tern "nuclear incident" means any occurrence, including an
extraordinary nuclear occurrence, within the United States causing,  within or
outside the United States, bodily injury, sickness, disease, or death, or loss
of or damage to property, or loss of use of property, arising out of or
resulting from the radioactive, toxic, explosive, or otner hazardous
properties of source, special nuclear, or byproduct material.

    Within the Nuclear Regulatory Commission, the Director cf Nuclear Reactor
Regulation reviews the safety and safeguards cf all facilities, materials,  and
activities under the Atomic Energy Act, including, but not limited to,
monitoring, tasting and recommending upgrading of systems designed to prevent
substantial health or safety hazards, and evaluation methocs of transporting
special nuclear and other nuclear materials and of transporting anc. storing
high-level radioactive wastes ~o prevt.^; iadia-ue hazards to employees and
the general puolic.

    The Office cf Nuclear Material Safety and Safeguards has a similar role
with an emphasis on safeguards against threats, thefts, and sabotage of
licensed facilities and materials.


    .ne regulations of  the Nuclear  Regulatory Commission are issued  under  the
authority of ths Atoxic Inargy  Act  of 1954,  42 'JSC Section 201'1.  The
resulat xon? are t ."."-lished in  10 C7"H Parts  0*170.

    "srt .':" ci 10 Cl"r, prescribes  standards for protection against radiation.
"ecticn 1', .2 vitnin this Par: offers  several definitions pertinent to  the
cesisnat'..™ ;:! radioactive satarials.   Radioactive aaterial is defined as,
"r-T.v sucr. s?t«ir:.al "-nether or net subject  tc licensing control by the  (Nuclear
regulator™; ^ocnissist".  Radiation is defined in this section as "any or  all
of the following:  alpha rays,  be*-a rays,  ganma rays, X-rays, neutrons,  high- .
speec electrons, high-speed protons,  and other atonic particles; hut not sound
cr radio vaves, or visible, infrared,  or ultraviolet light".

    Part 20 prescribes  standards  in teras  of "permissible dose levels  and
c :nce~,trs tionr." ?• r,vd;.3t ion  exposure for  workers and the public,  various
prec-auticiary  oro-ecures, arc  prescribed.   The basic-controls of the  Nuclear
kejuratory Cc.=;..snon -irs carried out through various licensing progress for
rj-;urce B&tarial. ;oecial nuclear material, and by-product material.  These are
ragulrcacl in ?i.rtj -C ,  ~C and 3C, respectivily of 10 CIR.  Part 40 cefinsis
scuris scitsrial as, "("-", uraniun or thorium, or any combination thereof, in
a~7 physical or caenical fsrrj cr (1)  ores  which contain by weight one-
~.sr.tieti: of one percent  ,'O.C5%)  or aore of:  'vi) uraniuni,  Cii) thoriun c:r
•'.11' any csobinatior thereof.   Source ssaterial does not include special
r.uc.esr aaterial".

    Spec..ia; nuclear aateriai  is defined in Ssction 70.4(m) as "(1) olutoniuz,
u-^.iur 121:, •-rc.n-um  enriched in the isotope 223 or in the isotope 235,  .and
~:~~*^ otne*!' niater^c. vciicn tne  '>.>otHwission,  pursuant to tne provisions  or 5action
21, of the ACT, detsratnes to  be special nuclear material, but does not include
source 3;.tc::s.-, cr  '1^ any material artificially enriched by any of the
:cregsin(; OUT  s.ots net  include  source aatarial".

    3y--;™ocuc.r saterial is defined  in Section 30.4(d) as, "any radioactive
aar-erial  ,'«cept special nuclear aaterial)  yielded in or made radioactive by
ftxpos'-re to »."U; rad_ation incident  to the  process of producing, or utilizing
special nuclear aaterial".  The sane term is given a somewhat different defi-
nition i.:: Section -0.-*(a-l).  There,  by-product material is defined  as,  "the
tailings sr wastes produced by  the  extraction cr concentration of uranium  or
thorium  froc a::y ore  processecs primarily for its source material content,
    s?rs'parsc  ',y  Lawrence W.  Sierlem, ?.C,, subcontractor to  ICT

including discrete surface washes resulting from uranium solution extraction
processes.  Underground ore bodies depleted by such solution extraction opera-
tions do not constitute 'by-product' material within this definition".  ~~
should be noted that the definition of by-product material  in Section -0.-  is
limited to the use of that term in Parr 40, whereas the definition  in Section
30.4 is for use in Part 30-35.

    Waereas the definitions of basically regulated materials are virtually
identical to definitions for these terms in the Atomic Energy Act,  there  is an
exercise of discretion in application of regulatory requirements to these
materials.  In addition, there appears to be significant use of exemption
authority to relieve certain defined materials from either  certain  regulations
or all regulations.

    Throughout the operative parts of the NRG regulations in 10 C7H, there  are
frequent references to exemptions and "specific exemptions".  The examp-  ticns
include exemptions by rule for low-hazard materials or people governed under
other regulations, or people who have only a peripheral contractual in-
volvement in the handling of radioactive materials.  Part 30.14, for axaspla,
is entitled "Unimportant Quantities of Source Material" and describes low-risk
materials and exempts people handling those materials from  various  require-
ments, generally including exemption from licensing requirements.  Throughout
the regulations one also finds reference to specific exemptions.  Part 30.11
reads that "The Commission may, upon application of any interested  perscr. or
upon its own initiative, grsnt such exemptions from the requirements of the
regulation in this part as it determines or authorized by law and will r.ct
endanger life or property or the common defense and security and ara otherwise
in the public interest".  In its deliberations upon an application  for exemp-
tion, the SRC must consider and "balance" the following factors:  ''(1) whether
conduct of the proposed activities will give rise to a significant  acverse
impact on the environment and the nature and extent of such impact, if any;
(2) whether redress of any adverse environmental impact or  ccncuct  of the pro-
posed activities can reasonably be effected should such redress be  r.ecassary;
(3) whether conduct of the proposed activities would foreclose subsequent
adoption of alternatives; and (4) the effect of delay in conducting such
activities on the public interest.  During the period of any exemption grantad
pursuant to this paragraph, any activities conducted shall  be carried cut in
such a manner as will minimize or reduce their environmental impact".

    Exemption alternatives such as that just quotad appear  in the following
parts:  20.501, 21.7, 30.11, 34.51, 40.14, 50.12, 51.-, 55.7, 70.1~, "1.6,
110.10(a), and 140.a.

    As can be seen from the proliferation of exemption sections, in idaiticr.
to exemptions by rule, the NEC's designation authority taxes the form of  con-
designation of hazardous materials.  In other words, the Atomic Energy Act  of
1954 defines materials to be regulated, and this statutory  rigidity is amelio-
rated by the exemption process through which specific people, materials and

ncti;:;-..',.  irr relieved  frcs the full  :_npact of regulatory requirements.  -:ri-
.ril"  ...ismir.;;.  ilthcugh ^ze rsgu.la-icr.s do discuss  rhe generic  ca.sg'iri
  ".cr.ia:—,  ?uc.b is  the scncsrn for the  public interest and the er.virazm^r.t,
.ese  ^"zerj i.re r^oc iz any fcras quantified acr is  the applicant for  an
espticr.  advised by the regulations
£^",:ti;:n  2.rcl;.nation.