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                                   3-25

'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
1938.7f

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).

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    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,

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                                   3-27

DRUG AMENDMENTS Cr 1962
    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
         accessories.'"

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.

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                                    2-2S

                        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).

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                                    3-29

          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

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 •. ;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

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                                   3-31

    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
         appearance.'l'J

    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
effective.
     l"2S
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        ..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.
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                                   3-33

         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/ .) .
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~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) .
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                                   3-35

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
purity."117

    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
drugs.

    Ii721 USC § 255(d).
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           .*^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
-------
                                   3-27

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).
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    " 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
•c."ifi
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                                   3-39

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
           Re
                    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) .
-------
                                   3-41

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.
-------
                                   3-43

                   (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
unsafe.1!3

    "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.
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                          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
-------
                                            3-45
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                             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.
-------
                                   3-«*9

     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
         PESTICIDES  WITH ESTABLISHED  TCH^ANC^S
                                                                     SECTION
  AC3PHATE
  ALAOU.OR
  ALL'MINUM PHOSPHIDE
                                                                      , .-
                                                                      ' '""' "
                              AND ™1MOI-ECJLAA CYCJC ANHYDROSCLHDE5

 AMMONIUM Sl^.FAMAT2 ,.......'.'..'. [[[ lln'~tl
 AQUEOUS EXTRACT OF SEA W«D .          ......................................... lin''"-
                                  "              ....... '
 3ARSAN
 BASIC ZJNCSULFATE
 3ENOMYL
 (BHCBEN2E.NHHEXAC-B.C1UDE
                        ................
 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 ................... [[[  !;-;•
                                       '
 3ROMOXYNIL
 3U7RAUN
                          .
                                ................................................ ''vi'-'~
 Wwr.3UTYL-2-CHLOROPKE.NYl. -.fETHn.' METHYLPHCSPHORAMlbAVs ..................  ' 3o':9<
                                                                •
 CALCUM CYANIDE
 CAPTAN ............           .................................
 CARBARYL ................                                                 ;'"'
 CARBCFCRAN    ..         [[[ 50-!'9
 CARBON oioxice  .....       .................................................  30-'i
 CAR3OPHENOTH10N ...........  [[[ 30.^9
 CAR8OX1N ............         [[[  'SO.. .16
 CHLORBENSIDE ........ [[[  :SO.:OI
 CHLCR3ROMURON .....     [[[  !30..a»
-------
                                                                            S£~!OV
                                   " A :=                                     NUM8EX'

IH- ORCX'JRC "i  [[[ J80JI16
.:--'Loa"YR.rcs [[[ iso.w:
c.?r     [[[ ;so.!8i
                                                                             i«o.is3
                                                    ............................ 180.119
                                                 i"HYL~iHY;.; 3EN3NS  *C3-
                                                                             180.575
                                                                             180.306
                                                                             ISO.M:
                                                                             iso.sjc
                                                                             180.1*6
     xs;iDi.i5 :N  CORN FCRACE. CORN  ^CDOES., COR.N sn^cs,  CORN STOVES..  ,»>JD
                         STt [[[ 180.U7»
                         -O^TOSpRODVCTSiN MI1K  ............................  ISO.ii'b
                                                                             180.105
                                                                             180J53
                                                                             1JQ.~
                                                                             isoj^i
                                                                             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
                                                                             180.100
                                                                             ISGJSI
                                                              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
o,c/-o-~.-. VL. ^-;-'VRAZ;NYL PHCSPHOROTHJCATS AND ITS OXYGEN ANALOG ......... ISOJSM
C!:"=^;uc^-^:  [[[  iso.369
D:!-JC:(vBEs~ENE ...................................... . .......................... 180J77
S-(C.C-'J!fSO"ROPv^ PHOSPHOROO.THlOATa) OF N-iI-MERCAPTOETHYi.)  BEN2NE-
  5LL.-ONA,Mia= ................................. , ..................................... ISO-4!
DI^E-HOATH INC. JDINC ~3 OXYGEN ^NALOC   ........................................ i8o.i&»
O.C-DtME~HYL O-tf-'DlMETHY', SUU-AMOYL) PHENY!. PHOSPHOROTH1OATE INCLUDING
  "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
                                                                             i80.j«
                                                                      CROTO-
                                                                             180.341
                                                                             180.231
-------
                                3-53 '
                             SXHI3IT 3-5




    PESTICIDES  WITH £STA3I.ISKSD  TGLZ3ANCSS  (Caaiiiued)

                                                                        SECTION
                                  NAME                                  NUMBER

DOOECACHLOROOCrAHrDRO-IJ.WKETHENO-m-OrC.OBUTAledlPEVTAL2.NE.	 ISO.:.'!
OOOINE	 ISO.It
ENOOSULFAN	 130.182
ENDOTHALL	 130^93
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
5-ErHOXY-%TRICHLOROMET>!YL.lJ.<-THlAOIAZOLE	 1SOJ70
S-ETHYL CYCLOHEXYLETHYLTHlOCARflAMATE	 ISO_:i:
ETHYL 4,*-OIOILOROBENZILATE	 ISO. 109
S-ETHYL DUSO8UTYLTHIOCAR8AMATS	 1SOJ3:
S-ETHYL OIPROPYLTH1OCAR8AMATE	.-.. 180.1 IT
ETHYLSMEOXIDE	 IIO.I.M
S-ETHYL HEXAHYDRO-! H-AZS?!NE-i-CARBOTHIOATE	._._.	 ISO-US

0-ETHYL S-PHSNYL ETHYL?HOSPHORCDtTH!OATE	 130-^1
0-ETHYL 0-WMETHYLTHIO) PHENYL S-PROPYL PHCSPHOROOITHIOATs	 130.JT4
N-(l-ETHYL?ROPYL>J,J-OIMETHYL-2.4-OIN!TRO8ENZ.\M!NE	 180.361
S-a-iETrlYLSULnNYL'.ETHYLl O.O-OIMETHYL PHOSPHORCTHIOA™  	 180.330
FsNTHION	 ISO^U
FERBAM	 180.11 *
FLLC-iLORALIN 	 !SO.:6:
FLUOMETURCN 	 180^19
FLL'ORINE COMPOUNDS	 '.80.1^5
FLL'OROOIFSN	 180^90
FOLPET 	 180.191
FCRMETANA—HYDROCHLORIOE	 180^76

GLYCD1N	 ISO.::*
GLYPHCSATE	 I30J64
GLYPHOSINE	 180.3 !•»
GOSSYPLURE  	 ISO.IWJ
HEPTACHLCR AND HEPTACHLOR EPOX1DE	 180.104
HEXACHLOROPHENE	 130.30:
HEXAKlSC-METHYL-2-PHENYLPROPYLi DISTANNOXANE 	 ISO.ra:
HEXAZ1NCNE 	180.:%
HYDROGEN CYANIDE	180.130
HYDROGSNATED CASTOR OIL	 130.1336
INORGANIC 3ROMIDE RESIDUES IN ?£ANUT HAY AND PEANUT HULLS	 180.U6a
INORGANIC 3ROM1DES OR TOTAL COMBINED 3ROMIDE RESULTING FROM rVMlGATION
  WTTH ETHYLSNE 01BROMIDE  	 180.1*6
INORGANIC 3ROMJOES RESULTING FROM FUMIGATION WITH METHYL 3RCMIDE	lSC.li:
INORGANIC  3ROMIDES RESULTING FROM SOIL TREATMENT WITH ETHYL2NE OI3RO-
  MIDE	 i8Q.::s
INORGANIC  3RCMIDES  RESULTING  FROM SOIL TREATMENT  WITH  ia-OIBRCMO-J-
  CHLOROPROPANE	 :SO.;97
INORGANIC  3ROMIDES RESULTING .-ROM SOIL TREATMENT WITH COMBINATIONS OF
  CHLOROP'CaiN  METHYL 3RCM1DE. AND ?RCP«.RAGYL 3ROM1CE	 180.199
INTERIM TOLERANCES	 '80-11?
ISGPROPAL.N	  ISO.; 13


LINOA.SE	 '	 !SO.:33
LINURON  	.'	 [80.13J
MAGNESIUM ARSENATE	 1 SO. 195
MALATHION  	 180.111
MAL21CHYDRAZ:SE	 ISO..-;
MANES	 :80.;;o
MANGANOUS OIMETHYL3ITH1OCARBAMATS  	 ISO 151
MAGNESIUM PHOSPHIDE  	  ISO..'*!
MERCAPTOBENZCTHIAZCLE
NnMERCAP^CMETXYLj ?HTHAL..M1DE S-0,0-Cl.MSTriYL PHCS
  ITS OXYGEN ANALOG	   :30.:SI
METHANE.-I.SSONIC-«.c:o	  iso"I*9
vtETriAZCLE 	  '..'.'.'..'.'..'. :io~:~:~
METT-ilDATHiON	                    'SC "-S
METHOMYL   	   	 'So"'-
MET>OPR£>E   	'  '.'''." '  '.' '.to~'9
METHCXYCHLCR  	  80.::a
-------
                             .uec ;
                                   SECTION
                                   NUMBER
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 	
^.;;:^T^^::jnA-AV1CACr 	
'"''"' >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 	
"•HC';?sA-.r.Dcv 	
" ' " ~'%~*>-"
* t>"^'^.vv1 ^' ""Jv*^£
* - ~ c^ i j AAe""NiT~
5-P90PY!, 3LT*. l-ETHYLTHIOCARSAMATc 	 	 	
$-?' jPv' "If1*'"1? " *"HIOCARBAMATE
-' \~ z " * 	 	 	 - 	
'--__• '•'__-•• s'- 	
----=. A_^ 	
SE3CM 	
^Vi'-'st.- 	 ' ' '
srriLMAKSE.s-.7i 	
;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 	 	
	 180.339
	 180.318
.... 180.338
. . ,» ;r
1 80 36S
ISO i"S

	 180.309
130 :'s

	 ;^
	 I80.16T
	 180.1050
. 180.260
	 150.J66
	 180.30*
	 180 J«
'80 "03

	 180.12!
.... 180.291
	 180.163
	 I80.J-S
	 180.278
180 P9
	 180.206
. . . 180.243
	 180.239
	 180.29:

	 180.238
	 I80.2W
	 180.316
180 123
	 180.166
180.102
	 180.213
, 180.196
	 180.152
	 180.383
	 180.310
	 180.245
	 180.! 12
	 180.1-9
	 180. Iff?
	 180390
	 180.209
	 180.352
	 180.333
	 180.245
-------
                               3-55
                             2XSI3IT  3-3




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

                                                                        SECTION
                                  NAME

TSXPSNE POLYCHLCRINA7SS [[[  130.16*
TiTilADlFON [[[  ISO.iTi
TETTlAETHYt. PYRCPHOSPHATa ..................................................  :M.J*7
THTRAHYORO-JJ-OlMETHYl.-aiH)-PYRIMIDINONa3-(*-n«n.UOROMETHY'_iPHSNYI_j-
                                                            !lAZONc .     'SO :95
                                                                         :SO.!62
0.0.0' .O'-TaTHAMETHYT. O.O'-THlCDI-p-PHENYLSNE PHCSPHORQTHICATH  ..........  :SO.!'0
rrfU3ENOA20L£ [[[  1SO.:«
iHTHIOCfANOMETHYUTHIOlBENZOTHlAJOLE .......................................   iSO.iSS
TH1OPHANATE-METHY1. [[[  1SO.J7 1
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
TTIICYC.OHEXYI.77N HYDROXIDE [[[  !30.l«
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
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                                   3-57

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)
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     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
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                                   3-59

     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
§343(c)"(3)(A)).

     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.: =
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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.
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                                   3-61

     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).
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        	,....'.-.'.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
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                                   3-62

     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.
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     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.
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                                   3-65

     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.
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     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 
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                                   3-67

     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.

         Criteria
     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).
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      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)).
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                                   3-=9
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.   "-'.
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     .::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).
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COSMETICS


     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,
               5'-tetrachlorosalicylanilide—TCSA)
           •    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-
mined.
      •"*  Lack  of  Authority  Kanreers  Attenrpts  to  Increase  Cosseti: Safety,
General Accounting  Office,  August 3,  1973.   HSJ3-73-139.
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    ." 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).
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                                   3-73

                               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.

Background

     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)) .
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           ".-= 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."
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                       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
interpretations.
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             FZSE5AL MEAT INSPECTION ACT, 1J POULTRY PRODUCTS
                    INSPECTION ACT.1- AND Z3G PRODUCTS
                   INSPECTION ACTJJ  -- STATUTORY RZVIIV
INTRODUCTION

    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.
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• — «-*>*•— — • — — — *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).
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                                   i-3

    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
              Agricultural-

    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.
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      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.
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               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
               U.S.C.A.
               § 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
               substance.23J
    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)-
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               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.  .  ."
-------
                                   i-9
                FEDERAL MEAT INSPECTION ACT, POULTRY PRCITJCTS
                 INSPECTION ACT. AND EGG PRODUCTS INSPECTION
                           ACT—REGULATORY REVIEW
INTRODUCTION

    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 ,
-------
                                             •4-11
                                       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 ;

                                                                                       3HT

               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 ;
                                                                                       3HT
                                   ..JO .	 .	JQ 		_ ._  0 03 3*rc**lt  A CC  5*i
                                                      >0wn u
                                                      lAusr;* Tiaoa "*m                 ;s^i*^i


                                                      3C««
                                    ao  ...._	JQ  	^.    so


                                    30                 30                 30
-------

                                                                                           Amouni
                                       To t
                                                              OMI or MCI trie
                                                              Oon
                 &HA iburncMS
                                                                                 001
                 BHT f
                                                               dc..

                                                               ao
                                                                                                 0 CJ pwewil
                                      IKX! Ortlv
                                      •tin SHA
                                      •no/or
                                      6MT
                                      M»»c an
                                      i*t
                                      eonwnt
                                    00' s«rc»ni
                                      tn
                                      csmcxi*-
                                      oon
                                                                                                 001
                                       To •rend ana
                                                            3r»«cir»; mi. uucn

                                                                ao		
                   IOMJIOM gumi
                                           00
                 Sooum caMiniii
          '^JSI


!•.  i', ,   • "^H
                                       To •nano and to
                                         subwn oroeuci
                                         ,«iio cam*-!

                                         3TOCUC1

                                           ao
                                           ao
                                         1  oo        ....
                                       To rnvnum  umlorm
                                         •ncosiry.
                                                     il
                                                   rr.tnor.
                                                         ... Eao ro»	
                                                            WMI «i-o
                                        To
                                         i»rrv «c
                                           ao
                                        To c»or cannot or
                                                 ! 11:3
                         DC
                         Oo

                         Oe
                     0 15 pwexit
StUMO*.
  10? m Pmn 3IS 01
  tfn uiocnaonir
Imrtauon sausao*.
  nontoaotic ioa««3.
  totnN. nmn
    00      	
    OOI.C>
                       m«iart«i
                       Mfl «ro
-------
                                                  4-13





                                  EXHIBIT  4-1  (Conrinued)

                            FOOD  SUBSTANCES:    MEAT  PRODUCTS
 <*••;« «l
  tour tie«anaru
                  Seoum
Ciong samtttun   Aacerac sxa..
  --nun a uses am
  ft cmroruoon nmn
                                        To o>»»»oi '
                                          3« CJAT«3 goOOl
                                                               90..
                                                               C3..
                                                            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:^-

                                                                         •j
                  Soaun wtnorc^i* 	     3o —
                  C.KX *aa or voawn        ao ...
                                            00
                                            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
                                                                                 porcaru
                                                                                 ace,
                                        To ':•« ?::K
                                                                                 •0  100 '5 ir>CC! ^r. --J0
                                                                                 :"<  ci :p TC o  ;.-.c:io
                                                                                 7* tin 
-------
•ic*.oroio»i
                  Scoum caoonata .... ...     so ....	
                  ZQ&vtri ctuconata ...  -       00     ....	
                  SOOHXTI rrvoro«o«  	      00  	. . .
                  Soowjm ri«i**'*caia          oo .-	- .
                                             oo   ... —	
                                             ao
                  2iac«vt tarnuc actQ
                    man ot mono aoo
                  lacimn

                  vaono ano t

                    •1C.)
    00			

To amuisry orocuc:
  laijo is arOCUC.
                                              Co
                                              Co
                                              Oo
                                              Oo
                                              00
                                              CC
                                              Oo

                                              Oo.
                                                                                        Do

                                                                                        Do
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)
                                                                 ssmposnion
                              l tor UM i
                              oaiau
                       9*>«a 30005
                        used >ntn aoiYtonaia  60
                        ttw eowieinao total !:iaii not
                        •>ca«a '  Bwcant
                                                                      .. ana toco«ncs
                                                                 ano n tn«
                                                                 iooos
                        »n« jrvcol.
                     ano o*sto^ ci
                     ana «ny aoos

                            i c"«j ot
                                                                 10009-
                                                               Shonamng to 0» usm  3 0 p«rce"i
                                                                 lex ca»» ongt and
                                                                                     SuAo«nt lor suroosa
                                                                                                        aiorw :i
                                                                                                             ?0
                                                                                       •K* cstrtsinoa aisi snan 1x31
                                                                                       aic**o '  aercam.
                                                                Snonaninc,
                                                                                         Oc
                                              oo

                                              CO  .
                          90


                          30
-------
                                             4-15
                                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
                   00
               Corn SVTUO VMS. corn
                 »vnjo.
                                   To aonci
To flavor OroOUO

    10

    •x
                                       30
                                       oo
                                       00
                     do
                  Cnm COrl carno
                  S«ua«o«  n.
                                                       ^>M sioducu
                  various'

                      30
                                          (-wci«ci 'Uivor
                                                          i'  ana
                                                                        Surtio«ri 'o«
                                                                        0 !  svcant
   JO
i 0 ytKKit
  «C^v«>
  cr» ^AA
                                                                           Co

                                                                           "o
                                                                        2 5 owcern
                                    'o 't*y
-------
                                                                 »-oouen
ir-xa; an
•Wl III 14 tliC OUFW^
       01
B«aioon«t« 01  JCG»_.
       itxjrm«o
    so
To no n
                 *nc«Cium oro»on»i*
                          ,s«o»on«i»
    oo

    ao
    oo -
To we >
    oe
                    as
                    as
                    w
                    oo
                                                                                    Oo
                                                                                    Oo
                                                                                    Oo

                                                                                    3c.
                                                                                    Do
                                                                                    Oc
                                                                                001
                                                                                Q 01
                                                                                  jro c»
                                                                                3.0C3
                                                                                  in
x -----   .. —  ?tmn oo««


*3 --- -..___.  Dn«l ma«s
                                                                                301  Mrexni on  B»ta a'  '«;
                                                                                  content n comonauc" wnn
                                                                                  anuouoanis.
                                                                                0 01  swtft on Bun at uaui
do
30
                                                            Lure «na inonwuog
                                                            Lure,
                                                                                0.02
                                                              son
                                                              rmuis
                 i<*oTy.iyve»oo« citriio
                                                            Lara  !f>ori*-'in$ "«n  3 02 pwcnm
                                                              oort :
                                                              mncu.
-------
                                               4-17
                               EXHIBIT i-1   (Conrinuad)


                         FOOD  SUBSTANCES:   MEAT  PRODUCTS


                     SuOtane*             Puna*              ^roouca              A/nount

                     fv
 . 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.
                                                                                        an
                                  „     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
                                                         :*con
                jaoofjfn arrn  al
                                                                                    '0
                                                                                 .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.

     C !*S;*3 S * 5 5"


iilMlaMHlHHI^a 5!
=-|s3S S§SS22SS3|    =
S — S C   O  O  3  «    O
                       I
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                                f
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ii^ll
f* tf> O 4?
                                       I JS

                                      all!
                                       Ss!
                                       O 
                •S-J-3
                1
                s.
                           s; i-
                          :isil^ = :.«
                          . s 3 • a 3 •«  . a :

                          f-|?l;  . -
                          • • 15 i 3 *   5
                          '*i5lf-|-3-"|
                            . 5. d 
•a
' • £
• H's
jt^J
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Slll^
i u u 02

•S ' • •
IS •
*3««'
litr
S J S"»
ill s
^ in i K.
                                 'I  •
                                *
                                          'HI
                                          a  5S
   r •
   S J
                                 r.o •S
                                   s
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-------
    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.
-------
                                      f-1
                     FEDERAL HAZARDOUS SUBSTANCES ACT--
                              ST.VTJTCRY REVIEW
BACKGROUND

    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.
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. .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.

SI"; STA>'CI."  C?X~~ED  AKD  STATUTORY CrilTZRIA
     .-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
         c.econrocsition,
    *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 .
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                                   5-3

         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
         hazard.i3J

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).
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                 ?N;S CF TZ?.MS "SE2 IN" 13 'JSC 1261
                                         je
                                    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 .
                                    §1261(k;.

            '                        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.
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                                    J-0
                                 EXHIBIT 5-2

                   DEFINITIONS OF OTHER TERMS USZS  IN  7HSA



    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^ •
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     -/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).
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                               2-7
                             EXHIBIT 5-2

               DEFINITIONS OF GTHZR TZR.M.S USED I.N FHSA
                             (Continued)


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).
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                  ..-.= ~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 .
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              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).
-------
                               5-10

     £,,.;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.
-------
                                   5-11

                   (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.
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           ::.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)
 .ver-
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                                   5-13

              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-
         dren.'38^

    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-
ticns."3:j

         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 .
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         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
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    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*:-

SU^IARY

    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'
510.
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        ,.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).
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                                   5-17
              (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).
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                    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
j.
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                                   5-19
                            ^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:; = '
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                       CONS
    .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).
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                                   3-21

    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-

SU3STANCIS COVERED AND STATUTORY CRITERIA

     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-.
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              — 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.
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                                   5-23

         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%-
Rice").
    i!-
        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).

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     . 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.
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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-
taents."3^.

    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).
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              ,. „'  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).
-------
                                   5-27

         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
held:

         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.
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          ,'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
                                       1*
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).
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                                   5-29

         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
test.

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).
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                _;   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"  ;•)-- =
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                                   5-31

SUMMARY

    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
activities.
       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 .
-------
                                    5-35
                       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
-------
                                   5-37

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.


PRODUCTS CSCLARZ3 TO 3£ HAZARDOUS SUBSTANCES - 16 CFR SECTION 1500.12

    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
              2(?)(1).

    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
warnings.

    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."
-------
                                    5-28

    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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                                   3-41

    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.


BANNED HA2AKDOU  SUBSTANCES - 16 CF3 SECTION 1500.17

    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
              monomer;

         •   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
              monomer;

         •    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
              products:

              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
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                                   5-43

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
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    .-t "r.t tuc.ic  .learins,  .-~i was inrorae.i t.-.at  consumer:, nave seer,  anc:  v:	
co-.tin-c  ~~ D-s  imposed  un:
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            POISON PREVENTION PACKAGING ACT -- REGULATORY  REVIEW
INTRODUCTION

    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
death.

REGULATORY CRITERIA

    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
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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
b
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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;
              and

         3.   Additional data which should be submitted for
              substances not intended for use in or en the  cunan cr
              animal body.

RZC-ULATZD SU3STANCES

    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
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                            '•>L'
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
(aethanci).

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
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                                   5-49

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.
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    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.
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            THE CONSUME?. PRCDCCT 3AFITY ACT  --  REGluATCRY  HEVTEV
INTRCr/JCTICN

    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
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               "~ ~. 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
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                                              5-53
                                          S3HI3IT 5-7

                                              roa a»amcco3 3g
                                           OTOES  C?SA
                                               Asoestcs    land
3.
C.
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
                                                                     Chlorc-
                                                                   lucrocarsons
        Snvironaer.tal Considerations
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       •; _ -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
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                                    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.

RZC-ULA7Z2 SUB STANCES

    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.

C?SC ACTTCN CM AS3Z3TCS

    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.-.
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       _;  . - *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
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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
                       C?SC

        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 ACTION ON LEAD PAINT

    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
regulations.
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ae

                                 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).
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                                   5-59

    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
                       lead

       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
                       oroducts
C?SC ACTICN CN CHLCRCFL'JCRCCARBCNS

    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
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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
                        lacking

        12-23-73        CPSC received more petitions and
       •>  2-2^-~s        information
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                                   5-61

                                 EXHIBIT 5-10

                             CHLCRQFLUOROCAR30NS
                            REGULATORY CHRONOLOGY
                                 (Continued)

       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
C?SC PROPOSED ACTION CN U3ZA-FORMALDEHYDE FOAM  INSULATICN

    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
product.

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.
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     .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.
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                            5-63

                          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
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    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.
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                                   6-2
                   ATCMIC LNI3GY ACT--STATUTCRY 3EVIEV1
    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
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                                   6-3
    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.
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    .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
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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
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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.
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