EPA-440/9-7G-008
                         CRITERIA .DOCUMENT






                          MDRIN/DIELDRIN

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                                 Errata

                  for Mclrin/Dielclrin Criteria Document


p. 5:     The first paragraph should read:  Based upon the data set forth
          herein, it  is concluded that a criterion of 0.003 ug/1 should be
          adequate for the protection of aquatic life.  However, it
          cannot be said that any level of aldrin or dieldrin in the
          environment is safe for huirans.  Therefore, all hurran exposure
          should be avoided.

p. 11:    Add the following to Table 2:

          Sand Shrimp (Crangon septerrispinosa)

          Exposure Time  (hr)     Method     LC50 (ug/1)    Ref

                96                  5            8         28


p. 24:    Add the following to the end of the  last paragraph:

          In Lake Michigan in 1968 the concentration of dieldrin was
          reported as 1.0 ng/1  (95).  Eased on the concentration of
          0.10 ng/1 in Lake Michigan alewife sarrples  (68), it can be
          inferred that the fish have accumulated dieldrin to levels
          100,000 time the aifbient water concentration.

p. 25:    The last line on this page should read:  much as 100,000 tiroes
          the dieldrin levels occurring in the v;ater  (68.95).

p. 27:    The third line, second complete paragraph should begin:

          in fish  (68, 95).

p. 34:    Add reference belay:

          95.  EPA, 1972.  An evaluation of DDT and dieldrin in
                Lake  Michigan, Ecological Research Series, EPA-R3-72-003,
                P. 10.

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                         ALDRIN/DIELDRIN

                        TABLE OF CONTENTS

 I.      Preamble.		            ]
 II.     Chemical-Physical  Properties	5
 III.    Toxicological  Data	        8
        a.    Mi crobes	   9
        b.    Invertebrates	    g
        c.    Fish...	       ^2
        d.    Bi rd s	j 5
        e.    Mammals			  ig
        f.    Human Health Hazard			19
IV.     Environmental Fate and Effects	21
V.     Criteria Formulation	25
VI-    References	      28
       Appendix    A
       Appendix    B

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                             INTRODUCTION
             CRITERIA DOCUMENTS FOR TOXIC POLLUTANTS

    Scientific rationale and criteria developed pursuant to Section 307(a)
of the  Federal Water Pollution Control Act, P. L. 92-500, 33 U.S. C. §§ 1251
et seq.,  (1972),. for the development and establishment of effluent limitations
for toxic substances are set forth in the following chapters.

    Section 307(a)(2) states inter alia that a proposed effluent standard
"..-. shall take into account the toxicity of the pollutant, its persistence,
degradability,  the usual or potential presence of the affected organisms in
any water, the importance of the affected organisms and  the nature and extent
of the  effect  of the  toxic pollutant on such organisms... " Thereafter, having
considered these factors,  the Administrator is to set an effluent standard
for toxic pollutants  which  provides an ample margin of safety.

    In  the development of criteria which serve as both the basis and the goal
for the establishment  of effluent limits, reliance was placed on the toxicity
data derived from laboratory studies on a range of organisms including
invertebrate, vertebrate,  and mammalian test species. These studies
provided extensive acute and chronic toxicity data based-on feeding experi-
ments  for a wide range of  aquatic organisms and consumers of aquatic
organisms.  Environmental studies documenting bioaccumulation in the food
web of the toxic material by the food chain organisms and bioconcentration
by organisms directly from water provided  an important component data
base upon which criteria were derived.  Appropriate human toxicity data
and mammalian carcinogenic studies, where available, were used also in
developing criteria.

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    Aquatic toxicity data generally are obtained by one of two basic



methods,  the static and flow-through bioassay.  The more traditional




static bioassay employs a tank in which the test organisms are living




and to which a given concentration of toxicant is added.  Any water



loss due to evaporation is made up by the addition of fresh water.  The



flow-through bioassay, which is  a more recent development, reflects



more nearly the natural conditions. Concentrations of toxic substances



are constantly maintained and provide a more accurate test of sensitivity



of aquatic species. Water in a flow-through test is replenished constantly



through flushing. Comparative results using the static and flow-through



bioassays demonstrate that flow-through data  yield lower toxicity values




for a pollutant than a static bioassay. This fact is demonstrated  by



comparative  studies as discussed in the endrin document. However,



most of the data available were developed using static bioassays.






    Some  toxic pollutants are extremely stable and degrade only  slowly



or form persistent degradation products.  Those pollutants which degrade




rapidly pose  a less severe long-term hazard unless their entry to



the environment is continuous. A parent compound, e.g., aldrin, may



rapidly degrade or be altered to a more toxic  form,  i.e., dieldrin.






    Bioconcentration of toxic pollutants is a significant consideration in



the development of criterion.  The rate and degree of accumulation in



an animal and the rate of loss from the animal are factors that help



define  the potential magnitude of the pollution  load problem. As an

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                                   3



example,  a pollutant which bioaccumulates presents a hazard both to



aquatic systems and potentially to man or other carnivores associated



with the ecosystem. To satisfactorily manage a persistent or



non-degradable pollutant requires the maintenance of a ceiling for



ambient levels in water which will afford protection to the food chain



and the consumers of aquatic life (animals including humans).  The



body burden of toxic pollutants in fish or food chain organisms may



have no outward effect  on the species but will affect consumers of that food



level.  As an  example, the brown pelican,  when feeding on endrin-contaminatec



fish may die or suffer species depletion  through reproductive impairment.






    Data on toxic effects of pollutants are not available for all species




that may be exposed to the toxic pollutant in  these complex societies.



Such data would be necessary to ensure protection of the most sensitive



species.  It is desirable to know  the relative sensitivity of a wide



variety of species in order to have a better estimate of the sensitivity



of the  untested, most sensitive species.  Because  such data are not



available on all species, the  range in sensitivity of a small number  of



tested species is used to provide a measure  of the range of sensitivity



of all  species.





    The natural aquatic environment includes many kinds  and life stages



of plants  and  animals that are intricately interrelated to  form communities.



Criteria are developed to protect these interrelationships and incorporate




aquatic toxicity data for a phylogenetic cross section of organisms as well as

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                                     4-            .  -






 species representative of wide geographic distribution.  Chronic




 studies are ap.-.important consideration in establishing criteria and require



 .studies of at  least one generation,  i.e..  one reproductive cycle.  Use of




 an application factor for persistent and bioaccumulated toxic pollutants




 represents consideration of a safety factor. As discussed in the



 National Academy of Science publication  on water quality (p. 185 of



 the NAS/NAE Water Quality Criteria -- 1972,  GPO-5501-00520), the



.use of  an application factor of 0. 01 when  applied to acute toxic values



 is  thought to  provide an ample margin of safety for certain chlorinated  v



. hydrocarbon  pesticides.






     Ecological importance  of an organism is dependent on the



 role the organism plays within the  ecosystem and upon its relationship



 to  the food chain within the aquatic  community and to consumers of



 aquatic life,  including man.  Thus, toxicity data for the top carnivores




 in  a given ecosystem,  as well as economically important species such




 as  trout, salmon,  menhaden and shrimp are needed for the development



 of  a protective criteria level.  Toxicity data for organisms  such  as the




 stonefly and Daphnia are of equivalent importance since these organisms



 are a food base for higher consumers and are representative of  invertebrate



 species found in most waters of  the United States.






    Invertebrate species, such as the stonefly and the Daphnia,  are an



 indication of the integrity of the  aquatic food chain and their presence



 may be the controlling factor for the abundance of economically  and

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recreationally important predators such as trout,  bass or pike. While



these fish may not directly consume the Daphnia or stonefly or, in




fact,  even inhabit the same waters,  these lower order organisms are



representative of the food  chain base supporting predators.






    Criteria levels,  by their nature,  are developed to protect aquatic



organisms and consumers of aquatic life from direct toxic effect when



placed on contact with the  toxic pollutants; and, to protect from a



more insidious and even greater danger, e.g., chronic effects.



Chronic effects take the form of reproductive failures  or  the poisoning



of predators consuming food organisms which have bioaccumulated levels



of toxic pollutants as in the case of the brown pelican and consuming



endrin loaded fish (see Attachment D, Endrin), and a variety of other



physiological effects as discussed in the various documents.   Decreases



in aquatic organisms or consumers of aquatic life  not always are coupled



to point source discharges of toxic pollutants at concentrations below



acute toxic levels; however, the addition of toxic levels which are not



acutely toxic can achieve the destruction or at least disruption of aquatic



systems by causing reproduction of failure.  Hence, the need for application



factors. The relationships between discharges of toxic pollutants and



effects on important organisms of economic  and environmental importance



and consumers of these organisms are well documented in the criteria



documents.

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                                   6
    An approach to criteria development is to provide ample protection
 of the test species on the assumption that the response of these species
 will be  characteristic of other associated organisms in the aquatic
 environment. A number of species have been considered in establishing
 a criteria

    Use of mammalian systems to determine the carcinogenic potential
 of toxicants found in  water follows the same principle as use of aquatic
 organisms to determine toxicity to fish and other organisms.   Carcinogenic
 substances pose a special hazard to man through environmental exposure.
 Cancer  producing substances may reach man by  several distinct pathways.

    The following four criteria documents for aldrin/dieldrin, DDT and its
 metabolites, endrin and toxaphene,  represent a survey of the scientific
 literature documenting the effects of these toxic pollutants to aquatic
life and consumers of aquatic life including man.  A glossary of terms is
provided to define the terms used throughout  the  documents and will be
expanded as necessary when additional documents are added.

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                          ALDRIN/DIELDRIN





 PREAMBLE






    Aldrin and dieldrin have been two of the most widely used domestic




 pesticides.  They are related chemical compounds of the chlorinated




 hydrocarbon family.  Although aldrin is used  in greater quantity than



 dieldrin, aldrin quickly transforms into dieldrin in the environment.



 Hence, there is concern with both compounds.  The primary use of the



 chemicals today is the control of corn pests,  although some is used



 by the citrus industry.






    Aldrin use in the U. S. peaked at 19 million pounds in 1966 but



 dropped to about 10. 5 million pounds in 1970.   During that same period



 dieldrin use decreased from 1 million  pounds  to about 670,000 pounds.



 The decreases have been attributed primarily to increased insect



 resistance to the two chemicals and to development and availability



 of substitute materials (69).  Actions to control the use of aldrin/dieldrin



 were taken by the  Environmental Protection Agency as early as 1971.



 These actions are explained chronologically as follows (69).






    In early 1970,  based on a concern to limit  dispersal of aldrin/dieldrin



 in the environment,  the U. S.  Department of Agriculture cancelled all



 registrations for these pesticides in or on aquatic areas.






    On December 3,  1970, the Environmental Defense Fund, Inc.



filed a petition  with the EPA requesting immediate cancellation and

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 suspension of all Federal registrations of aldrin/dieldrin products



 under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),



 as amended by the  Federal Environmental Pesticide Control Act of  1972,




 7 U.S. C.S, §135 et seq,  on the basis that these substances cause severe



 environmental damage and  are potential carcinogens.






    On March 18,  1971, the Administrator of the EPA announced that



 since the material  contained in the petition and in scientific literature



 raised a substantial question as to the safety of these products, the




 EPA would issue notices  of cancellation of all registrations of aldrin



 and dieldrin products.






    In response to a request by 84 companies whose products  would  be



 affected  by the cancellation order, a scientific advisory committee



 reviewed the matter and issued a report in March 1972,  recommending



 that the following uses be disallowed; all applications by aircraft;



 all foilage methods in  which residues are discharged into waterways



 or setting ponds; all uses in structures  occupied by humans or livestock;



 use on turf except as controlled by trained or licensed pest-control



 operators, greenskeepers and nurserymen; any use involving  application



 in aquatic environments.






   Because the Administrator in 1971 declined to suspend all



 registrations of aldrin/dieldrin during the pendency of administrative



proceedings relating to the cancellation, the Environmental Defense



Fund petitioned for review of this decision in the D. C. Court of Appeals.

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                                3






In May 1972, the Court remanded the matter to EPA for further




consideration in light of the advisory committee report, which was



issued on May 28, 1972, [Environmental Defense Fund, Inc.' v EPA,



465 F. 2d 528 (B.C. Cir. 1972)].






    In June 1972, an EPA order lifted cancellation of aldrin/dieldrin



for use in deep ground insertions for termite control, nursery dipping



of roots and tops of non-food plants, and mothproofing of woolen textiles



and carpets where there is no effluent discharge.  These are the only



registrations being accepted as of the present date.   Cancellation of




all other major uses of these chemicals was continued, and suspension



left open.






    During the course of the  cancellation proceedings substantial evidence



was developed indicating strongly that aldrin/dieldrin pose a  severe



hazard to human health as well as to the health of other organisms,  and




that it is a dangerous carcinogen.  Accordingly, the Administrator



announced on August 2, 1974, his intention to suspend the registrations



and prohibit the production for use of all pesticide products containing



aldrin or dieldrin which were the subject of the still-pending  cancellation



proceedings.  Following a hearing before EPA's Chief Administrative



Law Judge,  based upon detailed and extensive findings of fact and



conclusions,  suspension was recommended on September 20, 1974,  and



was then ordered by the Administrator  on October 1, 1974.  The



Administrator's Notice of Intent to Suspend and Findings  as to an



Imminent Hazard on August 2, 1974, together with the Recommended

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                                 4




Decision  of the Administrative Law Judge of September 20,  1974,



and the Administrator's Opinion and Order on the  suspension of October



1, 1!)74, wen; published in tin;  Federal  llrgiHtrr.  Vol.  :
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                                 5

    Based upon the data set forth herein, it is concluded that aldrin/

dieldrin are harmful to man and aquatic organisms even at very low

levels of concentration. It cannot be said that any level of aldrin

or dieldrin in the environment is safe, and therefore a prohibition of

any discharge is recommended.


I.  CHEMICAL-PHYSICAL PROPERTIES

    Aldrin  (1, 2, 3, 4,  10,  10-hexachloro-l, 4, 4a, 5, 8,  8a-hexa-

hydro-1, 4-endo—5, 8 -exo - dimethanonaphthalene) and dieldrin

(1,  2,  3, 4, 10, 10-hexachloro-6,  7 -epoxy-1,  4,  4a,  5,  6, 7,  8,

8a-octahydro-l, 4  -endo -5-8- exo  -dimethanonaphthalene) are chemicall;

related chlorinated pesticides which remain in  their toxic  form for an

indefinite period of time.  Physically aldrin and dieldrin are white
                                               o
crystalline substances  with aldrin melting at 104 C and dieldrin melting
                o
between 176-177 C.  Both are soluble in organic solvents with dieldrin

the least soluble of the two.


    Aldrin is metabolically converted to dieldrin.  This epoxidation has

been shown to occur in several species including mammals and poultry

(1), houseflies (2), locusts (3), soil microorganisms (4), a large number

of Lepidoptera species (5), freshwater fish  (6),  a number  of freshwater

invertebrates including protozoa,  coelenterates,  worms, arthropods,

molluscs (7),  and lobsters (8). The aldrin molecule is biologically

altered in the environment to a more stable and at least equally toxic

form,  dieldrin.  Dieldrin is known to be metabolically  degraded (9, 89);

however, its persistence in the environment is due to  its extremely low

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                                             -7                   o
 volatility (i.e.,. a vapor pressure of  l.~78xlO    mm mercury at 20 C)
                                             o
 and low solubility in water (186 ug/1 at 25-29  C) (10).  In addition, dieldrin

 is wxln-imely apolar.  resulting in a high affinity for fa I which allows tor its

 retention in animal t'ats, plant waxes and other non-polar organic matter

 in the environment.  The fat solubility of dieldrin results in the progressive

 accumulation in the food chain which may result in a concentration in an

 organism which would exceed the lethal limit for a consumer species.



    The affinity of  aldrin/dieldrin for animal tissue,  a function of low water

 solubility and the high water partitioning coefficient, shows bioaccumulation

 is not affected by concentrations of aldrin/dieldrin in  water.  Many organ-

 isms not in direct contact with contaminated water and sediment acc:umu-

 lalu aldrin /dieldrin from the food supply.  Thin biological concentration

 results in tissue concentrations many  times those found in the surrounding

 environment (16).  Concentrations increase in the food chain reaching the

 carnivores  at the "top" including man.



    Dieldrin is probably the most stable insecticide among the cyclodienes

 (i.e.,  isodrin-endrin; heptachlor - heptachlor epoxide). The time required

for 95 percent of the dieldrin to disappear from soil has been estimated to

vary from  5 to 25 years depending upon the microbial  flora of the soil

 (12).  Dieldrin applied at 100 ppm has  been shown to persist in  soil for more

than 6 years (14), while at 25 ppm in a different soil type, a 50 percent loss

was found after 7 years  (15).  When applied to  sandy soil at a rate of 100 ppm,

 residues could be found 15 years later (15). Matsumura and Boush (9) found

 that of 577  bacterial isolates collected from areas heavily contaminated with

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dieldrin.  10 isolates would alter dieldrin to 2 to 9 unknown metabolites.



The microbes were members of Pseudomonas. Bacillus and



Trichoderma genera. Subsequent microbiological studies have



revealed that Aerobacter aerogenes also will alter dieldrin  similar to



6,7- trans-dihydroxydihdroaldrin (13). Chacko, et^al. (11) tested the ability



of 17 species of fungi and actinomycetes.  Though most degraded PCNB or



DDT or both, none degraded dieldrin.





    Patil and co-worker in 1972 studied the metabolic transformations of



aldrin/dieldrin by marine algae, surface film,  sediments,- and water.  They



found the insecticide was not degraded or metabolized in sea water or pol-



luted waters.  Some marine algal populations have been shown to degrade



aldrin to dieldrin (89).





    Alteration of dieldrin by bacterial systems  results in the formation



of at least one acidic product  (9). Once in the fatty tissue of organisms,



dieldrin remains stable  (16).  However, dieldrin can be mobilized from fatty



tissue; for example,  when fish are placed in an environment without dieldrin,



there is an elimination from the tissue (17).  The elimination  rate depends



upon the diet with fasted fish eliminating dieldrin more rapidly than from



fed fish because of the utilization of fat stores (18). The dieldrin



eliminated from the tissues reenters the water  and thus become available



for bioconcentration by other  organisms. The movement of dieldrin among



organisms,  water,  and sediment is dynamic, with equilibrium attained when



the chemical concentration is  constant.

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II.  TOXICOLOGICAL DATA






   Toxic effects resulting from the presence of aldrin/dieldrin in water




have been documented for aquatic organisms representing a wide




phylogenetic cross section and geographic distribution. While all test




organisms used may not be universally distributed in the waters  of the




United States, they represent types of organisms present in fresh,  marine




and estuarine systems throughout the country.  Extrapolation  from the




effects found in laboratory and field tests is a  reliable means  for predicting




effects of aldrin/dieldrin on individual organisms and their food chains and




is recognized as such by the scientific community.






    It should be noted that LC50 values reported for static tests  are




likely to be substantially higher than  LC50 values found using  flow-through




bioassays.  For instance,  Earnest et_ aL  (93) reported both static and flow-




through 96-hr aldrin TL50 (LC50) values for two species of surf perch,




Cymatogaster aggregata and Micrometrus minimus.  The former  yielded a




static value of 7. 4 ug/1 and a flow-through value of 2. 26 ug/1, while




Micrometrus minimus yielded a static TL50 (LC50) of 18.0 ug/1 and  a flow-



through TL50 (LC50) of 2.03 ug/1.  These data suggest loss of toxicant in




static bioassays. Static tests in which dissolved oxygen and toxicant con-



centrations are measured periodically are more reliable than those in which




these parameters  are not monitored. The flow-through bioassays more




accurately reflect nature,  where "container wall" effects are  likely to be




negligible and where the volume of water per fish is  much greater.

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                                 9


    Toxicological data sho.w aldrin/dieldrin to be acutely toxic to aquatic

invertebrates(27), to fish (91,93), to birds (46),  and to mammals (61).

although mammalian acute toxicity is relatively low.


    a)   Microbes

    Information regarding the effects of aldrin/dieldrin on bacterial and

algal populations is  limited. Bacterial species carrying out the conversion

of ammonia to nitrate were inhibited when aldrin concentrations were be-

tween 100,000 to 10,000, 000 ug/kg (21). Studies of the effect of dieldrin on

soil bacteria demonstrated  a reduction in the numbers of bacteria at soil

pesticide concentrations of  between 100 to 1000 ug/1. Recovery of bacterial

populations varied depending upon species, and required from 7 to 28 days

to reach pretreatment numbers and diversity (23).  Similarly,  diatom species

are able to survive concentrations of dieldrin greater than invertebrates and

vertebrates.  A 50 percent reduction in the diatom population resulted from

an application of 12, 800 ug/1 dieldrin (22). However the growth rate of four

types of marine phytoplankton has been  reduced 50 percent by  dieldrin

concentrations ranging from about 100 ug/1 to about 500 ug/1 (32).


    b)   Invertebrates

    Sensitivity of invertebrate organisms to  aldrin-dieldrin is  several

orders of magnitude greater than that of microbial organisms.

Dieldrin distributed at 1 Ib/acre in a Florida marsh resulted in a

complete annihilation of the crab population  and virtual elimination of

other crustaceans (24).

                             REGION III LIBRARY
                             ENVIRONMENTAL PROTECTION AGENCY

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                                 10

   Aldrin and dieldrin toxicity to invertebrates is seen in Table 1 and
Table 2, and indicate that both compounds are extremely toxic to arthropods.
Sensitivity of the stonefly, Agroneuria pacifica, to dieldrin in a 20-day
continuous flow bioassay system was 0.2 ug/1 (37). A sensitive marine crab,
Leptodius floridanus, exhibited delay in development at concentrations of 1
and 0. 5 ug/1 dieldrin (38).  At 0. 9 ug/1 dieldrin there was a 55 percent mor-
tality in commercially valuable pink shrimp, Penaeus duorarum,  within  96
hours  (H4).  Dieldrin is more toxic than aldrin to the insect,  Pteronarcys
californica. and  the  crustacean,  Gammarus lacustris (30).  Aldrin has
been shown, to be more toxic than dieldrin to the crustacea, Simocephalus
serrulatus.  and Daphnia pulex (30, 31).

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                                 11

                               Table 1
      Acute Toxicities for Various Invertebrates Exposed to Dieldrin
           Species
                                Exposure
                                Time (hr)
 Stone fly
 Stone fly
 Stonefly
 Stonefly
 Stonefly
         (Pteronarcella badia)        24
         (Ulaassenia sabulosa)        24
         (i^teronarcys caiifornica)    24
         (Pteronarcys caiitornica')    48
         (Pteronarcys caiifornica)    96
Method

   S
   S
   S
   S
   S
                                              S
                                              S
                                              F
                                              F
                                              F
                                              F
                                              S
                                              S
                                              S
LC50
  (ug/1)

   3
   4.5
   6
   1.3
    .5

1400
Amphipod (Gammarus lacustris)      24

Waterflea (Simocephalus serrulatus)  48
Waterflea (Daphma pulex)	~  43


Grass Shrimp (Palaemonetes pugio)   96
Pink Shrimp (Penaeus duorarumT    96
Brown ShrimpTPenaeus azTecus)      24
Brown Shrimp (Penaeus aztecus)      48
Sand Shrimp (Crangon septemspihosa) 24
Sand Shrimp (Crangon septemspinosa) 48
Sand Shrimp (Crangon septemspinosa) 96

S: Static Bioassay
K- Flow-through Bioassay

                               Table 2

      Acute Toxicity for Various Invertebrates Exposed to Aldrin
Ref.

  27
  27
  27
  27
  27

  29
          240{EC50)  31
         250(EC50)  31
           8.64     . 34
           0.7       34
          25(EC50)   90
           5. 5(EC50) 90
          68         28
          10         28
           7         28
          Species
                                Exposure
                                Time (hr)
Amphipod (Gammarus lacustris)         24
Sand Shrimp (Qrangon septemspinosa)    24
Sand Shrimp (urangon septemspinosa')    48
Hermit Crab (Pagurus longicarpusl—    24
Hermit Crab (^agurus longicarpus)      95
Stonefly (Simocephaius  serruIamsT       48
Waterflea (baphnia pulelc)	~~~~        43
                                            Method
                                               S
                                               S
                                               S
                                               S
                                               S
                                               S
                                               S
           LC50
           ug/1
             45
             30
             14
            300
             33
            Ref.
             29
             28
             28
             28
             28
             23(EC50) 31
             28(EC50) 31

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                                12
    c)  Fish
        When exposed to dieldrin at 1.35 ug/1 for four days, estuarine fish,
 LeioHtomuH xanthurus, were found to have degenerative change3 in gills and
 vi3ceral tissue (34).  Growth rates and  reproductive performance of the sailfin
 molly,  Poecilia latipinna.  were adversely affected during a 34-week exposure
 to 0.75 ug/1 dieldrin  (35).
    Cairns et al.  (36) found that in the first two or three months of exposure
 to concentrations of dieldrin ranging from 1. 8 to 10 ug/1 guppy populations
 increased more among exposed groups than among controls.  The  authors
 attributed this to decreased predation by adult fish on the young.  After about
 six months this population  difference disappeared, apparently because the
 exposed groups were  less successful reproductively. Growth rates of rain-
 bow trout,  S. gairdneri, were  reduced by dieldrin concentrations in water
of 0. 12 ug/1 and above, but eggs survived  at concentrations of 52 ug/1 (42).
The LC50 for various fish  species is seen  in Table 3 for aldrin and in Table
4 for dieldrin.
                              Table 3
                 Toxicity of Aldrin to Various Fishes
Exposure
Species Time (hr)
Rainbow trout (Salmo gairdneri)
Jtsluegin (JLepomis macrochirusi
Goldfish (Carassius auratusl
Atlantic siiverside (Menidia menidia)
Allan lie siiverside (Menidia menidia)
Atlantic siiverside (Menidia menidia)
Juvenile White Mullett (Mugil curema)
Bluehead (Thalassoma) 	
Bluehead (Yhaiassoma)
Stnped miTiiish (Fundulus majalis)
Striped Killinsn (Fundulus majalis)
Striped Killifish (Fundulus majalis)
48
96
96
24
48
96
48
24
96
24
48
96
Method
U
U
U
S
S
S
F
S
S
S
S
S
LC50
ug/1
aldrin Ref.
31
5.2
28
45
20
13
2. 8 (Tim)
15
12
58
26
17
44
44
40
91
91
91
90
91
91
91
91
91

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 Cont. of Table 3
                                 13
                     Toxicity of Aldrin to Various Fishes
Exposure
Species Time (hr)
Striped mullet (Mugil cephalus)
Striped mullet (Mugil cephalus)
American eel (Anguiila rostrata)
American eel (Anguilla rostrata)
Mummichog (Fundulus heteroclitus)
Mummichog (Fundulus heteroclitus)
Northern runer(Sphaeroides maculatus)
Bluehead (Thalassoma bii'asciatmm
Striped Bass (Mo rone saxatilis)
Shiner perch (Cymatogaster aggregata)
Shiner Perch (Cymatogaster aggregata)
Dwarf Perch (Micrometrus minimus}
Dwarl Perch (Micrometrus minimus)
24
48
24
96
24
96
96
96
96
96
96
96
96
Method
S
S
S
S
S
S
S
S
F
S
V
S
F
JLUDU
ug/1
Aldrin Ref.
126
100
18
5
22
8
36
12
7.
7.
2.
18.
2.
91
91
91
91
91
91
91
91
2(TL50)92
4 93
26 93
0 93
03 93
 S= Static Bioassay
 F= Flow-through Bioassay
 U= Unknown
                             Table 4

                 Toxicity of Dieldrin to Various Fishes
Exposure
Species Time (hr)
Bluegill (Lepomis macrochirus) 96
Juvenile White Mullet (MugiFcurema) 48
Shiner Perch (Cymatogaster aggregata) 96
Shiner Perch (Cymatogaster aggregata) 96
Dwarf Perch (Micrometrus minimus) 96
L>wari perch (Micrometrus minimus) 96
Atlanuc Silverside (Menidia menidia) 24
Atlantic Silverside (Menidia menidia) 96
Slnped Killiiish (Fundulus majalis) 24
Striped Killifish (Fundulus ma.]alis) 96
Bluehead (Thaiassoma bifasciatum) 96
Srripea Mullet (Mugil cephalus) " 96
American eel (Anguilla rostrata) 48
American eel (AnguiUa rostrata) 96
Mummichog (Funduius heteroclitus) 24
Mummichog (Fundulus heteroclitus) 96
Northern Puner(Sphaeroides maculatus) 96
Striped tsass (Morone saxatilis) 96
Method
U
F
F
S
F
S
S
S
S
S
S
S
S
S
S
S
S
F
LC50
ug/1
Dieldrin
2.8
7.1(TLM)
1. 50
3.7
2.44
5.00
10.
5.
9.
4.
6.
23.
4.
.9
20.
5.
34.
19. 7(TL50)
Ref.
44
90
93
93
93
93
91
91
91
91
91
91
91
91
91
91
91
92
S = Static Bioassay
F = Flow-through Bioassay
 = Unknown

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                                14






    Data on the toxicity of aldrin and dieldrin  ingested by aquatic or-




 ganisms indicate that the compounds can be toxic at water concentrations



 of 2. 03 ug/1 and 1. 5  ug/1 respectively  (93).  Aldrin/dieldrin also has been




 reported to alter biological mechanisms of fish. Dieldrin at 0. 36, 1. 08,



 3.6, and 10. 8  ug in food fed to rainbow trout for 240 days Salmo gairdneri,



 altered brain concentrations of amino acids associated with ammonia de-



 toxifying mechanisms,  aspartate,  glutamate and alanine,  as well as the



 enzymes related to their metabolism (39).






    The 24-hour TL50 (LC50) for rainbow trout, S.  gairdneri.  exposed to



 aldrin has  been shown to be temperature dependent  and to increases with



 increasing water temperature.  At temperatures of 1. 6 C, 7. 2 C and 12. 7



 C the 24-hour  TL50 (LC50) values were 24 ug/1. 8. 1 ug/1, and 6. 8 ug/1,



 respectively. Similarly, data for bluegills.  Lepomis macrochirus, showed



 an effect of temperature.  At temperatures of 12. 7 C,  18.3 and C and 23. 8C,



 the 24-hour LC50 concentrations were  36 ug/1, 16 ug/1 and 10 ug/1,  respec-



 tively  (43).  Data presented in Tables 5 and 6 illustrate that the 24-hour,



 48-hour, and 96-hour TL50 (LC50) values are time and temperature related.






    Dieldrin has been shown to affect adversely the ability of the freshwater



 fish, Etheostoma nigrum,  to withstand thermal stress when exposed to a



 level of 2.3 ug/1 for  30 days (41).  The  mortality of those exposed to aldrin



 was greater than the non-exposed population.  In additon,  changes in  the



 oxygen consumption,  whole body  lipid and liver condition were affected



 adversely in fish after 15  days of exposure.  These conditions later returned



to within normal ranges except for liver damage which progressed with time.

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                        15
                      Table 5
Effects of increasing temperature and exposure time on
           the toxicity of aldrin to bluegill* (44)
    Temperature                        LC50 (ug/1)
      F   (C)

                             24-hr.        48-hr.     96 hr.

    45    (7.0)                130.          26.4        9.7
    55   (12.7)                  36.8         12.5        7.7
    65   (18.3)                  16.4          8.3        6.2
    75   (23.8)                  9.3          6.7        5.6

^weight of fish approximately 1 g.
                      Table 6

Effects of increasing temperature and exposure time on
           the toxicity of dieldrin to bluegill* (44)

    Temperature                        LC50 (ug/1)
    F      C
                             24-hr.         48-hr.     96-hr.

   45   ( 7.0  )                 54             34         16
   55   (12.7)                 40             26         18
   65   (18.3)                 24             18         14.5
   75   (23.8)                 14             11          9.3
   85   (29.4)                 10              8.4        7.1

^weight of fish approximately 1 g.

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                                16






 d)  Birds






    The dieldrin oral LD50 for the sharp-tailed grouse is reported to be




 6. 9 mg/kg of body weight (94).  Long-term feeding studies of birds have



 resulted in the characterization of a variety of sub-acute and  chronic toxic



 effects attributable to aldrin and dieldrin, which are typical of the  chlorinat-



 ed hydrocarbons.  Fertility among surviving female pheasants was  lower



 than in the control group (45).   Feeding dieldrin to pheasants at G mg/ per



 week for 13 weeks resulted in no mortality in the parents but the offspring



 of these hens when fed a diet with 6 mg dieldrin/week for 14 weeks.showed



 75 percent mortality.  Visual cliff tests also showed adverse behavioral



 changes in chicks  Hedged from hens fed 8 mg/week for 14 weeks (45).



 Pen-reared,  5 week old pheasants were fed with encapsulated aldrin at 0. 5.



 1. 0, and 1. 5 mg/week for  seven weeks, and another group with 0. 5 mg on



 alternate days to a total dose of 1. 5 mg.  Treatments of birds between  the



 ages of 5 and 21 weeks with either 1. 0 mg/week or 1. 5 mg total dose was



 found to depress growth. Fifty percent of the birds receiving the 1.5 mg/week



 dose died within 48 hours of the first treatment (46).






   Dieldrin fed to Japanese quail at dietary levels of 0-40 ppm showed



 a definite relationship between dosage  and mortality.  The highest



no-effect  level as measured by growth, health or behavior was  10 ppm.



At higher doses, egg production and fertility were reduced.  Hatched



chickes fed dietary levels greater than  10 ppm suffered mortalitites



within  2 or 3  days  of hatching  (48).

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                                 17






    The question of chlorinated hydrocarbons and their effects on avian



 calcium metabolism,  steroid hormone metabolism and reproduction has



 been the subject of numerous investigations which have often resulted in



 conflicting data. The major cause of declining predatory bird populations



 in the  last 20 years has been from a drastic drop in reproduction and not



 in the  killing  of adult birds.  The failures in reproduction follow a similar



 pattern among the various species and involve delayed breeding or failure



 to lay  eggs, thinning  of eggshells and subsequent breakage,  and high mortal-



 ity in embroys and newly hatched birds.  Recent studies  show persistent



 organochlorine pesticides induce liver enzymes that lower estrogen levels



 and result in  late breeding and other related reproductive manifestations (49).






    Dieldrin was fed to 43 of 78 nesting female prairie falcons by tethering



 dieldrin-contaminated starlings  (fed  10 ppm for 14 days) in  sight of the



 falcons.   Birds fed more than three treated starlings averaged dieldrin



 tissue  levels  eight  times those of untested falcons.  A straightline correla-



 tion was found between the amount of dieldrin consumed  and  the residual



 levels  in the  birds' fat and eggs.  Eggshells from 34 untreated birds (egg




 dieldrin  1. 9 ppm) were significantly thicker than from seven treated birds



 in which egg  dieldrin  averaged 41. 5 ppm. At dieldrin concentrations of



 less than 20 ppm in the egg, there was no difference in the thickness of



 eggshells. The data establish a correlation between pesticide residues,



 thin eggshells, and poor hatching success (50).  Studies of male chickens,



pheasants, and quail exposed to aldrin  showed the chemical to  have  a



feminizing effect on all three. This is thought to be due to reduced



testicular size and  altered hormone metabolism (52). Reproduction  of

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                                 18
 mallard ducks, pheasants, and bobwhite quail was reported reduced or



 inhibited by diets containing as little as 0. 5 ppm aldrin (53).





 e)  Mammals






    The LD50 for rats has been reported to be 54 to 56 mg/kg body weight



 for aldrin and 50 and 55 mg/kg for dieldrin (61).  The oral dieldrin LD50



 value for the dog is reported to be 65 to 95 mg/kg (61).






    Administration of single oral dose of dieldrin to rats at 30 mg/kg of



 body weight resulted in impaired liver function (62).  Impaired liver function



 also was found to occur in a number of animals species including man (62).



 Impairment of reprodution in a variety of mammalian species has been found



 to result from exposure to aldrin-dieldrin.  A dieldrin dietary level of 100



 ppm was found to induce abortion in  guinea pigs and was lethal to one-third



 of the pregnant and one-half of the non-pregnant animals (64).






    Dieldrin has been reported to be transferred from the mother to



 blastocyst and from mother to fetus  in pregnant rabbits  (54).  In



 continuous feeding studies, neo-natal mortality in dogs and rats  has been



 shown to increase (55, 56).  A level of 2. 5 mg/kg of 85 percent dieldrin



 has been reported to  produce fetal malformations in Wistar rats (57).






    Repetitive oral doses of up to  15  mg/kg dieldrin administered to



pregnant sows during the last 30  days of gestation resulted in placental



transfer to. the embroys.   Some degeneration of the kidneys tubules and



slight hepatic lipidosis were osberved in the sows. No lesions were



detected in the fetuses and there were no letal deaths or abortions (58).

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                                19

 Aldrin/dieldrin has also been shown to cause cytogenetic aberration in
 mice (59).  In two studies comprising five long-term oral studies feeding
 dieiann to u.f-i mice at  various concentrations,  liver enlargements and
 tumors were detectable.  Appearance of tumors was dose responsive since
 tumors occurred 9 months following feed treatment with 10 ppm; 19 months
 with 5 ppm;  and 23 months with 2. 5 ppm.  Further, the total groups all
 experienced a decrease in survival rates.  At intake rates of 1. 25 ppm and
 1 ppm dieldrin, no liver enlargements were detected clinically and survival
 was not affected (60).

 f) Human Health Hazard

    Aldrin and dieldrin are highly mobile and persistent chemicals that  are
 not lost by dilution or  degradation in the inorganic components of the en-
 vironment.  The pesticides persist in  the soil for several years, where
 they are absorbed by the roots and  transported to the aerial parts of se-
 quentially planted crops,  such as soybeans  and corn.  Many of these
 products are important feed components for animals. The pesticide
 residues are thus  incorporated, directly and indirectly, into the milk,
 meat,  poultry,  and soy products consumed by humans (See Appendices
 A and B hereto for an extensive discussion of the human hazards).

    Evidence that aldrin-dieldrin poses a  cancer hazard to man is
provided by the mouse laboratory data.  The carcinogencity  of aldrin/
 dieldrin to mouse strains  other than the CF-1 studies mentioned above
 (60) have been published (66).  Although the liver is the principal organ

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                                20




 affected in the mouse and was a major site of action in rats, there was


 also an increase in tumorc of the lungs and other organs (66).




   .Aldrin poisoning of humans may occur by ingestion, inhalation and/or


 skin absorption. Severe symptons may result from ingestion or per-


 cutaneous absorption of as little as 1 gram,  especially in the presence of


 liver disease.  Renal damage,  tremors  ataxia, convulsions,  followed by


 central nervous system depression,  respiratory failure and death are


 symptoms resulting from acute exposure. Chronic  exposures over a pro-
                                                                      X

 longed period may result in liver damage (66). In humans, pregnancy


 has been observed to offer a degree of protection from dieldrin in-


 toxication to the mother, but  at the expense of the fetus which concen-


 trates dieldrin Ln its tissues (65).            .      .        \




   . Chemicals  known to cause cancer in man have been identified only


 through epidemiological studies, either in the general public or in


 occupationally  exposed  workers.  In the case of aldrin/dieldrin.


 epidemiological studies have not been possible because there are no


 clear-cut differential levels of exposure and because the period of


 exposure has been too short.  Some cancers in man do not develop


until late in life, usually 20 years or more after initial exposure  (66).


Animal studies are accepted as determining factors when assessing the


carcinogenic potential of a chemical to man.
                                                   v



   Mouse and  rat systems are commonly accepted experimental  animal


species, both because their relatively short life span permits lifetime


testing within a reasonable period of time and because the pathological

-------
                                 21
development of tumors in these species is particularly well known and




understood  (66).  A number of experiments  have shown, as noted above,



that aldrin/dieldrin induces cancer in five different strains of mice and




perhaps in the rat.  Based  on these data this Agency  concluded  in the




FIFRA proceedings,  noted  above,  that aldrin/dieldrin pose a serious



cancer risk and health threat to man (66).






III.   ENVIRONMENTAL FATE AND EFFECTS






    Movement of aldrin and dieldrin into the aquatic ecosystem  is of



critical importance since,  once having entered water, these chemicals



are extremely persistent and toxic.  Basically,  as with other organo-




chlorine pesticides,' aldrin/dieldrin enters water by one of three routes,



physical transport,  chemical transport or biolgical transport. It is



virtually impossible to identify all of the various physical factors affecting



movement of persistent organic chemicals such as aldrin/dieldrin(70)






  Characteristics of the soil in which aldrin and dieldrin are  found



are of importance in determining the rate of movement of the pesticide.




It has been found that volatilization is one means of loss of these pesticides



from sand and moist soils with low organic content. Temperature is



another parameter of considerable importance,  as it  has been found that



the half-life of dieldrin in a sandy loam  decreased with temperature;



however,  this loss apparently is not due to volatilization (71).

-------
                                  22






    Aldrin and dieldrin are persistent in the environment, but aldrin



is readily converted to dieldrin in both  living and non-living sites (72).




After its  conversion from aldrin,  dieldrin is metabolized or degraded



under a variety of circumstances, but generally at a very slow rate.



Some microorganisms,  insects and mammals have been shown to



degrade dieldrin and under certain conditions.  Sunlight can cause similar



degradation.  Overall decomposition  rates, however, are inadequate



to prevent its persistence in the biosphere (14).  The photoconversion



of aldrin by ultraviolet light should be emphasized,  since in nature




residues of this pesticide in sunlight  could result in reactions significantly



affecting living organisms. Experimental UV irradiation of aldrin has



been shown to produce dieldrin and aldrin photoconversion isomers



almost quantitatively (73, 74).  There  is evidence that these isomers



are even more toxic than the original compounds when tested with insects



and fish (75).  In general, although aldrin and dieldrin are not highly



reactive  chemically in the environment, the  reactions they undergo tend



to increase their potential for  harmful biological effects  (23).






    A fundamental fact to be emphasized in considering organochlorine



pesticides in the biosphere is their virtual water insolubility and



high lipid solubility, which facilitates storage by fatty tissues.  Aldrin



and dieldrin are preferentially soluble in living  (especially lipid)




systems which almost always indicate slower metabolism and turnover



than observed in aqueous interactions (14,16).   Microscopic plants

-------
                                 23






and animals present highly variable responses to aldrin and dieidrin.



Although almost all of them accumulate these chemicals to some extent,



it is probable that they are relatively immune to acute lethal effects.



In algae, aldrin and dieidrin do not build up to levels seen with DDT;



however,  16, 000-fold magnification over the concentration in the medium



has been observed (76). Over 500 bacterial isolates have been studied



from soil and few of them  have been found to degrade dieidrin  (9).  In this



study, Matsumura and Boush concluded:





    (1)  Dieidrin is one of the most stable and hazardous insecticides



       in our environment.



    (2)  This persistence suggests it is of low biochemical reactivity .



    (3)  The potent effects of aldrin/dieidrin depend on forming physical



        complexes with nervous systems of insects and mammals.



    (4)  Most chlorinated hydrocarbon insecticides have little  effect on



        bacterial and fungal  growth.



    (5)  Many microbial changes brought about by application of these



       insecticides to soil may be attributable to secondary effects.





    As noted above,  the extent of lipid metabolism probably is a decisive



parameter in bioaccumulation of these  substances as evidenced by laboratory



studies which show concentration factors for dieidrin from water of 114,935



in snails, 7,480 in algae,  6,145 in fish, 247 in crabs and 1,015 in clam (16).

-------
                                  24
 Parrish (34) reported whole body residues in spot (Leiostomus xanthurus)
 as much as 6,000 times water concentration in 11 to 18 days' exposure.

     The alga, Scenedesmus obliguus. the waterflea, Daphnia magna, and
 theguppy.  Poecilia reticulata. have been found to accumulate dieldrin
 directly from water.  The average concentration factors (concentration
 in organisms, dry weight, divided by concentrations in water) were 1,282
 for  algae,  13, 954 for D. magna,  and 49, 307 (estimated) for the guppy
 (79).  The  amount accumulated by each species at equilibrium was
 directly proportional to the concentration of dieldrin in water. Accum-
 ulation of dieldrin by guppies resulted from exposure to either con-
 taminated water or to their food source, which was Daphnia magna  (79).
 The ostracod. Chlamydotheca arcuata.  has been shown to accumulate
 dieldrin at  levels of 12, 000 to 260, 000 times that of the initial theoretical
 concentration in water (77).

    Studies  on degradation of dieldrin by biological systems other than
 microbial have been also relatively unsuccessful. Because of these find-
 ings it has been concluded that ho biological systems are important in
 reducing the actual toxicity of dieldrin entering their metabolism (9).

   Residues of aldrin and dieldrin have been found in most molluscs,
fishes,  birds  and mammals  studied regardless of location in the
world (19, 20).  Rainwater,  drinking-water, and non -potable waters in
Hawaii were sampled and found to contain dieldrin in the low parts per
trillion  range  (78).                                .          .

-------
                                 25






   Aldrin-dieldrin intake in mammalian systems has been shown to




cause liver damage, kidney damage, and behavioral disturbances




(10,  58,  60,  62, 80).






   Data from laboratory studies using mice have demonstrated that




dieldrin is a  potent carcinogen (60,  10) and potential carcinogenic danger




to humans experiencing intake of low dieldrin levels from either food




or water has been established (66).






IV.  CRITERIA FORMULATION






     The persistence, bioaccumulation potential and carcinogenicity of




aldrin-dieldrin make avoidable human exposure unreasonably hazardous.




A chronic criterion .003 ug/1 would provide for the protection of aquatic-




life.






     Aldrin-Dieldrin has been found to be toxic to aquatic organisms at




low levels.   The Aldrin-Dieldrin 96-hr  LC50 to fish is reported as low




as 1. 50 ug/1 for shiner perch,  Cymctogaster aggregata (93).  The 96-




hr LC50 for  striped mullet, Mugil cephalus is 23 ug /I, (91), and for




the striped bass,  Morone saxatilis the 96-hr TL50 (LC50) has been  shown




to be 19.7ug/l (92).






    Residue  accumulation of dieldrin and aldrin is well documented.




Levels of dieldrin in fish tissue from Lake Michigan have been as




much as  100,000 times the dieldrin levels occurring in the water  (68).

-------
                                  26
 Laboratory exposures of fish, invertebrates, and algae have indicated



 that residue accumulation of aldrin and dieldrin is significant. The



 reticulate sculpin (Cottus perplexus) exposed to 0.017 ug/1 dieldrin in



 water for 32 days developed tissue concentrations of 50, 000 times the



 water exposure level (82).  The sailfin molly (Poecilia latipinna) exposed



 for 34 weeks to 12,  6,  3,  1.5 and  0. 75 ug/1 dieldrin in water concentrated



 dieldrin in all tissues at least 10,000 times (35). At the termination



 of a 64-week exposure of the Ostracod (Chlamydotheca arcuata) to water



 concentrations of aldrin at 0. 01  and 0.10 ug/1 and dieldrin at 0. 01 and



 . 10 ug/1. dieldrin recovered from the  tissue {dry weight basis) were



 12,000 to 260,000 times the initial theoretical water concentrations (77).



 In a model ecosystem study, residue accumulation factors for  dieldrin



 were determined, to  be 114, 935 times water concentration for the snail,



 7,480 times water concentration for algae, 6, 145 times water  concen-



 tration for fish,  2,145 times water concentration waterfleas, Daphnia,  sp.,



 1, 280 times water concentration for a pond weed,  Elodea,  and 247 times



 water concentration  for  the crab, and 1,015 times water concentration



 for the clam  (16). Other bioaccumulation studies have indicated similar



uptake levels (76, 79, 83.  84).- With dieldrin at a concentration of 0. 5



ug/1,  the rate of uptake by the crab larvae (Leptodius floridanus) in 18 days



was 0.191 ug/g per day from, water (85).





   In long-term feeding studies, 1 mg/kg dieldrin affected reproduction



in the Hungarian partridge (86).  Slight eggshell thinning was noted in

-------
                                        27
 . '•   mallard ducks fed  a diet containing 1.6 ppm (mg/.kg) of dieldrin (07).

      'Deer were affected adversely by long-term feeding of a diet containing
'-.*  •*   "   '          • .              ,                 .
 .' _r   5 ppm (mg/kg) of dieldrin (88).                .    .,  ';.'.        •'.  " •


       .   The highly mobile and persistent nature of'aldrin-dieldrin,  as well as

    •.  its capability for becoming incorporated into  products consumed by

  •  •  humans, results in an imminent human health hazard in  view of its

     • carcinogenicity.   Walker, et al.  (60) demonstrated'.the  tumorigenie

•:"'-: •  activity of dieldrin to CF-1  mice.  Levels which resulted in rumor        %

    "•• formation can be found in aquatic  food chain organisms as a result of

      bioaccumulation from water.      '     '  '•".•'".'••      '•/•••       '•"'•:•


   : .   .  Bioaccumulation studies with aldrin-dieldrin have shown that tissue

   '.  . residues up to 100,000 times the ambient water concentration  occur

      in fish  (68).   Since the  FDA tissue residue guideline for  aldrin/dieldrin

      is 0. 3 ug/1,  water levels higher than.003 ug/1 could result in           '   •

 ... bioaccumulation to levels above .3 ppm in fish flesh.   Therefore the

   -.. chronic criterion for aquatic life is  set at.003 ug/1. The primary impact

•-  . .  of this bioaccumulation in fish and their food  sources centers on the

 •  '•   biological transport of  aldrin-dieldrin to birds and mammals including man.

      The chronic toxicity criterion^ of  0.003 cg/1 is based  on  toxicity factors

      apart fruu carcincgenicity.               •     _               "

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                               28
 References

 1.  Barm,  J. M.,  T. J. DeCino, N.  W. Earle and Y. P.  Sun.  1956.
       The fate  of aldrin and dieldrin in the animal body.   Jour.  Agri.
       Food Chem.  4_:937.

 2.  Brooks,  G.  T.  1960.  Mechanism of resistance of the adult housefly .
       (Musca domestica) to,  cyclodiene, insecticides.  Nature.  186:96.


 3.  Cohen,  A. J.  and J. N. Smith.   1961.  Fate of aldrin and dieldrin in
       locusts.  Nature.  189;600.

 4.  Lichtenstein,  E. P. and K. R. Schulz.   1960.  Epoxidation of aldrin
      •and heptachlor in soils as influenced by autoclaving, moisture,  and
       soil types.  Jour. Econ. Entom. 53;192.

 5.  Krieger, R. I.,  P. P. Feeny,  and C.  F. Wilkinson.  1971.   Detoxi-
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       to plant defenses ?  Science.   172;579.

 6.  Ludke,  J. L., J. R. Gibson and  C. I. Lusk.  1972.  Mixed function
       oxidase activity  in freshwater fishes:  Aldrin  epoxidation and para-
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 7.  Khan,  M. A. Q., A. Kamal, R.  J.  Wolin and J. Runnels.  1972.
       In vivo and In vitro  epoxidation of aldrin by aquatic food chain
       organisms. ""Bull. Environ. Contain,  and Toxic.   8_:219.

 8.  Carlson, G. P.   1974.  Epoxidation of aldrin to dieldrin by lobsters.
       Bull.  Environ. Contam.  and Toxic.  11:577.

 9.  Matsumura, F.  and G. M. Boush.   1967.  Dieldrin:  Degradation by
       soil microorganisms.  Science.  156:959.

10.  IARC Working Group.  1974 Dieldrin.  IARC monographs on the
       Evaluation  of Carcinogenic Risk of Chemicals to man:  Some
       organochlorine pesticides.  5:125.

11.  Chacko. C.  I.,  J.  L.  Lockwood  and M.  Zabik.   1966. Chlorinated
       hydrocarbon pesticides:  Degradation by microbes.  Science.
       154;893.

12.  Edwards^ C.  A. 1966.  Insecticide residues in  soils. Residue Reviews.
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13.  Wedemeyer, G.  1968. Partial hydrolysis of dieldrin by Aerobactor
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14.  Westlake, W. E. and J.. P. San Antonio.  1960.  Insecticide  residues
       in plants, animals and soils.  In: The nature and fate of chemicals
       applied to soils, plants,  and animals.  U. S.  Dept. of Agriculture,
       ARS 20.  9:105.

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                               29
15.  Nash, R.G. andE.A. Woolson. 1967.  Persistence of chlorinated
       hydrocarbon insecticides in soils.  Science.  157:924.

16.  Sanborn,  J.R. and C.C.  Yu.   1973.   The fate of dieldrin in a model
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17.  Brockway,  D. L.  1973.   The uptake,  storage and  release of dieldrin
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18.  Grzenda,  A. R. ,  W. J. Taylor,  and D. F. Paris. 1972. The elimina-
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19.  Butler, P. A.   1973.  Organochlorine  residues  in estuarine mollusks.
       National Pesticide  Monitoring Program.  Pest.  Monit. Jour.  6_:238.

20.  Wurster,  C.F.   1971.  Aldrin and dieldrin.  Environment.  13:33.

21.  Jones, L. W.   1956.  Effects of some pesticides on microbial activities
       of the soil.   Utah State Agric. College Bull.  390:1.

22.  Cairns, Jr., J.  1968.   The effects of dieldrin on diatoms.  Mosquito
       News. 28_:177.

23.  Gaur, A.C. and M. C. Bardiya. 1970.  The effect of lindane and dieldri.
       on  soil  microbial populations.  Indian Jour. Microbiology. 10:33.

24.  Harrington, R. W. and W. L. Bidlingmayer. 1958.  Effects of dieldrin
       on  fishes and invertebrates of a salt marsh.  Jour. Wildl. Mgmt.
       2_2_:76.

27.  Sanders,  H. O. and O. B. Cope.  1968.   The  relative toxicities of
      several  pesticides to naiads of three species of stoneflies.  Limnol.
      Oceanog.  13:112.

28.  Eisler, R. 1969.  Acute toxicities of insecticides to marine decapod
      crustaceans.  Crustaceana.  16:302.

29.  Sanders,  H. O.   1969. Toxicity of pesticides to the crustacean.  Gamma?.
       lacustris.  Tech. Paper 25, Bur. Sport Fish. Wildl.,  U.S. Departme
       of the Interior, 18p.

30.  Federal Water Pollution  Control Administration.   1968.  Water quality
       criteria.  Report of the National Tech. Advis. Comm. to Sec.
       of the Interior. Fed. Water Poll. Cont.  Admin.,  U.S. Department
       of the Interior, 234 p.

-------
                               30
 31.  Sanders, H.O.  andO.B. Cope.  1966.  Toxicities of several
      pesticides to two species of Cladocerans. Trans. Amer. Fish
      Soc. 95_:165.

 32.  Menzel, D.W., J. Anderson and A.  Randtke. 1970.   Marine phyto-
       plankton vary in their response to  chlorinated hydrocarbons.
       Science :1724.

 34.  Parrish, P.R.,  J.A. Couch, J. Forester, J. M. Patrick,  and
       G.H. Cook. 1973.  Dieldrin: Effects on several estuarine
       organisms. Contrib. No. 178, Gulf Breeze Environ. Res.  Lab.
       Proceedings of the 27th Annual Conference of the Southeastern
       Association of Game and Fish Commissioners.

 35.  Lane, C.E.  andR.J. Livingston.  1970.  Some acute and chronic
       effects of dieldrin on the sailfin molly, Poecilia latipinna.
       Trans. Amer. Fish. Soc.  3:489

 36.  Cairns,  J.,  Jr.,  N.R. Foster,  andJ.J. Loos.  1967.  Effects of
       sublethal concentrations of dieldrin on laboratory populations of
       guppies, Ppecilia reticulata Peters.  Proc. Acad. Nat. Sci.,
       Phila., 119;75.

 37.  Jensen,  L. D. and A. R. Gaufin.  1966.  Acute  and long-term  effects
       of organic  insecticides on two  species of stonefly naiads.  Jour.
       Water Poll. Cont.  Fed. 3£:1273.

 38.  Epifanio, C,E.   1971.  Effects of dieldrin in seawater on the develop-
       ment of two species of  crab larvae, Leptodius floridanus and
       Panopeus herbstii.  Mar. Biol.  11:356.

 39.  Mehrle,  P.M. andR.A.  Bloomfield.  1974,  Ammonia detoxifying
       mechanisms of rainbow trout altered by dietary dieldrin.
       Toxic. Appl. Pharm.   27:355.

40.  Henderson, C., G.H. Pickering and C. M. Tarzwell. 1959.  The toxicity
       of organic  phosphorus and  chlorinated hydrocarbon insecticides to fish.
       Biol. Problems in Water Pollution, Trans. 1959 Seminar.
       Robert A.  Taft San. Eng. Center,  Tech. Rep W60-3_:76.

41.  Silbergeld, E. K. .  1973.  Dieldrin:  Effects of chronic sublethal
       exposure on adaptation  to thermal stress in freshwater fish.
       Environ. Sci.  Tech., 7_:846.

42.  Chadwick,  G. and D. L.  Shumway.  1969. Effects of dieldrin  on the
       growth and development of steelhead trout.   In: The biological impact
       of pesticides in the environment.  Environ. Health  Sciences Series
       No.  1,  Oregon State University, pp. 90-96.

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                               31
 43.  Macek, K.J.,  Hutchinson,  C.  and Cope, O. B.  1969.  The Effects
       of temperature on the susceptibility of bluegills and rainbow
       trout to selected pesticides.  Bull. Envir. Cont. and Tox.
       4jl74.


 44.  Cope,  O. B.  1965.  Sport Fishery Investigations. Fish and Wildl.
       Serv, Circ. 226, Bur. Sport. Fish Wildl. pp. 51 -64.

 45.  Baxter, W. L. , R. L. Linder and R. B.  Dahlgren, 1969.   Dieldrin
       effects in two generations of  penned hen pheasants.  Jour  Wildl
       Mgmt.  33_:96.

 46.  Hall, J.E., Y.A.  Greichus and K. E. Severson.  1971. Effects of
       aldrin on young pen-reared pheasants.  Jour.  Wildl. Msmt
       3J5:429.                                               6

 48.  Walker, A. I. T. , C. H.  Neill, D. E.  Stevenson and J.  Robinson.
       1969. The  toxicity of dieldrin (HEOD) to Japanese quail (Coturnix
       coturnix japonica)  Toxicol. Appl. Pharmacol.  1_5:69.

 49.  Peakall,  D. B.  1970.  Pesticides  and the reproduction of birds
       Sci.  Amer. 222:73.

 50.  Enderson,  J. H. and D. D.  Berger.  1970.  Pesticides:  Eggshell
       thinning and lowered production of young in prairie falcons
       Bio.  Sci.  2£:355.

 52.  Lutz-Ostertag, Y.  and H. Lutz.  1969.   Preliminary note on the
        estrogemc   effects of "aldrin" on the urogenital tract of the
       bird  embryo.  Compt. Rend. ; Res. D. 269(4): 484.   Health Aspects of
       Pest. Abst.  No.  70-0627.                                    H

 53.  Chichester, C. O.  (editor).  1965.  Research in  pesticides.
       Academic Press, New York.

 54.  Hathaway, D. E. ,  J. A. Moss, J. A. Rose  and D. J.  M.  Williams.
       1967.  Transport of dieldrin from mother  to blastocyst and from
       mother to foetus  in pregnant rabbits.  European Jour. Pharmacol.
       1 :167.

 55.  Treon, J.  F.  and F.  P.  Cleveland.  1955.   Toxicity of certain
       chlorinated  hydrocarbon insecticides for laboratory animals  with
       special  reference to aldrin and dieldrin.  Agric. Food Chem'.
       o :
56.  Kitselman,  C. H.  1953.  Long term studies on dogs fed aldrin and
      dieldrin in sublethal dosages, with reference to the histopathological
      findings and reproduction.  Jour.  Amer.  Vet. Med. Assn.  123:28.

-------
                               32
 57'  B°iUQC7anrd VM* ' L  S> Beaulaton- R- Mestres. M.  Allieu and S.  Cabane.
                                                     duration of treatment.
 58.  Uzoukwu  M. and S. D. Sleight.  1972.  Effects of dieldrin in pregnant
        sows.  Jour.  Amer.  Vet.  Med. Assn.  160:1641.


 59.  Markarjan  D.  W.  1966.  Cytogenetic effect of some chlororganic
        insecticides on the nuclei of mouse bone-marrow, cells
        Geneticla. 2_;132.                            .


 60.  Walker  A/ 1. T.. E. Thorpe and D. E.  Stevenson. 1972.  The

        riT,l0gyTr0f^ldrin.(HEOD)-  L Long-term oral toxicity studies
        in mice. Food Cosmet. Toxicol. 1£:415.


 61.  Spector   W. S.  (ed. ) 955.  Handbook of toxicology. Volume 1- Acut-

          1C
      NASr  °W,3'   qUS 8nd Ga3eS t0 Lab°-tory Animas
      NAS-NRC.  W.B. SaundersCo.,  Philadelphia, pp.  14,15,96,97.

 62.  Bhatia  S  C.  S. C. Sharma and T. A. Venkitasubramaniam.   1972.
       Effect of dieldrin on certain enzyme systems  of rat liver   Br
       Jour. Exp. Pathol.  _53:419.

 64.  Uzoukwu. M. and S. D. Sleight.  1972.  Dieldrin toxicosis-  Feto-
       toxicosis, tissue concentrations, and microscopic  and ultrastmctural
       changes in guinea pigs.  Amer.  Jour. Vet. Res.  33_:579.

 65.  Nowak  W.  W. Lotocki.  H. Szrzedzinaki.  A.  Strasiewicz and
       J.  Badurski.   1971.  Dieldrin poisoning during pregnancy   Pol
       Tyg. Lek.  2_5:958.   Health Aspects of Pest.  Abst.  No. 72-0532*.

 66.  Shell Chemical  Company,  et al.  Recommended decision of
       Administrative law Judge. "EPA FIFRA Docket Nos.  1*5 etc   39 F R
       37246-37265 (October 18.  1975).  Reprinted in Appendix A hereto.


 68-  R      •                                       -
70.  Peterle  T  j  1959.  Translocation of pesticides in the environment.
        CL     biological impact of pesticides in the environment --a symposium
             ln     S1^lficaCe °f Pesticid" in relation to
      hlt                                          n  o  coogcaoe
      h^A*  En+vf°n^ental Health Series No.  1.  Proceedings Sf syrAposiurS
      held August 18-20, at Oregon State Univ.. Corvallis, Oregon. Pl-210

71.  White, A. W   1970.  The influence of moisture,  temperature, and
                   A^T dlf PPearance of ii^dane and dieldrin from soil.
                   Abstracts International.  30:5327

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                               33
 73.  Rosen,  J. D.  and D.  J.  Sutherland.  1967.  The nature and toxicity
       of the photoconversion products of aldrin.  Bull. Environ. Contam.
       and Toxicol. 2_:1.

 74.  Crosby, D.  G. and K. W.  Moilanen.   1974.  Vapor-phase photo-
       decomposition of aldrin and dieldrin.  Arch. Environ. Contam.
       and toxicol.   2_;62.

 75.  Georgacakis,  E., S.  R.  Chandran, and  M. A. Q, Khan.  1971.
       Toxicity-metabolism relationship of the photoisomers of  cyclodiene
       insecticides in  freshwater animals.  Bull.  Environ. Contam. Toxicol
       6_:535.

 76.  Rice, C. P. and  H. C.  Sikka.  1973.  Fate of dieldrin in selected species
       of marine algae.  Bull. Environ. Contam.  Toxicol.   9_:116.

 77.  Kawatski, J. A.  and J.  C. Schmulbach.   1971.  Accumulation of
       insecticide in freshwater ostracods exposed continuously  to sub-
       lethal concentrations of aldrin or dieldrin.  Trans. Amer Fish
       Soc.  :565.

 78.  Bevenue, A..  J.  W. Hylin, Y. Kawano,  and T.  W. Kelley.  1972.
       Organochlorine residues in water, sediment, algae and fish,
       Hawaii--1970-1971.  Pest. Monit. Jour. £:56.

 79.  Reinert, R.  E.  1972. Accumulation of  dieldrin in an alga  (Scenedesmus
       Obliqus),  Daphnia magna and the guppy (Poecilia reticulataTi   jour.	
       Fish.  Res. Bd. Can.  29:1413.	

 80.  Avar, P. and  G.  Czegledi-Janko.  1970.  Occupational exposure to
       aldrin: Clinical and laboratory findings.  Brit.  Jour. Ind. Med
       27_:279.


 82.  Chadwick, G.  G.  and  R.  W. Brocksen.  1969.  Accumulation of
       dieldrin by fish and  selected fish-food organisms.   Jour.  Wildl
       Mgmt. 33_:693.

 83.  Johnson, B. T. ,  C. R. Saunders and H. O. Sanders.  1971.
       Biological magnification and degradation of DDT and aldrin by
       freshwater invertebrates. Jour.  Fish.  Res. Bd. Can. 28_:705.

84.  Petrocelli,  S.  R., A.  R. Hanks,  and J.  W. Anderson.  1973.  Uptake and
       accumulation of an organochlorine insecticide (dieldrin) by an
       estuari.ie mollusc Rangia cuneata.  Bull. Environ. Contam. Toxicol.
       1£:315.

85.  Epifanio, C. E.   1973.  Dieldrin uptake by larvae  of the crab
       Leptodius floridanus.  Marine Biology.  19;320.

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                               34
86.  Neill, D. D., etal.  1969.  58th Annual Meeting Poul.  Sci. Assn.  76.

87.  Lehner, P. N.  and A.  Egbert.   1969.  Dieldrin and eggshell thickness
      in ducks.  Nature.  224;1218.

88.  Murphy, D.  A.  and L.  J.  Korschgen.  1970.  Reproduction, growth,
      and tissue residues of deer fed dieldrin.  Jour. Wildlife Mgmt.
      34:887.

89. Patil, K. C.,  F. Matsumura, and  G. M.  Boush. 1972. Metabolic
       transformation of  DDT, dieldrin, aldrin, and endrin by marine
       microorganisms.  Environ. Sci. and Tech.  6_:631.

90. Butler,  Philip A..  Commercial fisheries investigation. In: '
      Pesticide Wildlife Studies:  A Review of Fish and Wildlife Service
      Investigations  During  1961 and  1962, U.S. Dept Interior, Fish and
      Wildlife Service Circular 167,  pp 11-25.

91.  Eisler, R.  1970. Acute toxicities of organochlorine and
      organophosphorus insecticides to estuarine fishes,  In: Technical
      Papers of the Bureau of Sport Fisheries and Wildlife, No. 46, U. S.
      Government Printing Office,  Wash. D.C.

92.  Korn,  S.,. and  R.  Earnest,  1974,  Acute toxicity of twenty
       insecticides to striped bass,  Mo rone saxatilis. Calif.  Fish and
       Game 60: 128.

93.  Earnest, R., and  P. E.  Benville,  Jr. 1972, Acute toxicity of
       four organochlorine insecticides to two species of surf  perch,
       California Fish and Game. 58: 127.

94.  McEwen, L. C., and R. L.  Brown, 1966. Acute toxicity of
        dieldrin and  malathion  to wild sharp-tailed grouse. Jour.
        Wildlife Mgmt.  30:604.

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                            GLOSSARY






Acutely toxic:  Causing death or severe  damage to an organism by




    poisoning during a brief exposure period, normally ninety-six




    hours or less.






Anadromous fishes:  Fishes  that spend a part oF their lives in seas




    or lakes, hut as<-r;nd rivers and streams at certain intervals to ..




    spawn.  Kxamples are sturgeon,  shad,  salmon, trout, and




    striped bass.






Application  Factor: The ratio of the safe concentration to the lethal




    concentration as determined for- potential aquatic pollutants




    administered to species of interest.






Bioaccumulation  (Hioconcentration):  The phenomenon wherein elements




    or compounds are stored in living organisms because elimination .




    Fails to match intake.






('ureinogenir :  Producing (lancer.






Catadromous Fishes:  Fishes that feed and grow in Fresh  water, but




    return to the  sea  to spawn.  The best example is the  American



    eel.






Chronically toxic:  Causing death or damage to an organism by




    poisoning during prolonged exposure, which, depending on the




    organism tested and the test conditions  and purposes, may range



    from several days,  to weeks, months, or years, or through a



    reproductive  cycle.

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                            36
 EC50:  The concentration at which a specified effect is observed

    under the test conditions in a specified time? in fifty peivc-nt  of

    UH: or-gunisms lusted.  Examples of specified HTeH.s ;irr lirmor-

    rhaging, decreased feuding, dilation of pupils, and altci—d

    swimming patterns.


 Epilimnion:  That region of a body of water that extends from the

    surface to the top of the thermocline and does not have a  permanent

    temperature stratification.


 Mow-through bioassay:  An assay system in which aquatic species

    arc (.-xposed to toxicants in a constantly flowing system, and where

    the  toxicant is replenished continuously or di.scontinuously.


 Hardness (water;:   rne concentration of the polyvalent metallic  ions

    dissolved  in water.   Unually it. is  reported as the equivalent

    concentration of calcium carbonate  (CaCQ  ).
                                            :*

 llyperplasia:  Abnormal multiplication or increase in the  number

    of normal cells  in normal arrangement in a tissue.


Hypolimnion:  The region of a body of water that extends from the.

     bottom of the thermocline to the bottom  of the water body and

     is  essentially independent of most  surface phenomena.

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                     37
LC25: The conc'entration of n toxicajit that is lothal (fata!) to twenty-

    five percent of the organisms tested under the test conditions in

    a specified time.


L(!.r>0: The ronreritralion of a loxicanl which is lethal (I'alnP to

    fifty peree.nl. of the organisms tested under UK.' test condiLions

    in a specified  time.   II is virtually identical wit.h TLui and TLT)0.


LU50: The dose of a toxicant that is lethal (fatal) to fifty percent

    of the organisms tested under the test  conditions in a specified

    time.   A dose is the quantity actually administered to the

    organism and  is not identical with a concentration, which is the

    amount of toxicant in a unit of test m'edium rather than the

    amount ingested by or administered to the organism.
Liter (I): The volume occupied by OIK.' kilogram of water at a pressure
                                                 o
    of 7(>0 mm of mercury and a lempc-rature of 4  ('.  A liter- is

    1. 057 quart.
Methylmercury;  Mercury which has been methylated, usually through.

    some biological agent,  such as bacteria.


Microgram per liter (ug/1): The concentration at which one millionth

    of a gram (one  microgram) is  contained in a volume of one liter.

    Where  the density of solvent is equal to one, one ug/1 is equiva-

    lent to  one  part per billion (ppb) or one microgram per kilogram

    (ug/kg).

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                          38
 Microgram per kilogram  (ug/kg): The concentration at which one




    millionth of a gram (one microgram) is contained in a mass of




    one kilogram.  A kilogram is 2. 2046 pounds.






 Milligram per kilogram (mg/kg):  The concentration at which one




    thousandth of a gram (one milligram) is contained in a mass '>!'




    one kilogram.  A gram contains 1000 milligrams.






 Milligram per liter (mg/l):  The concentration at  which one  milligram




    is contained in a  volume of one liter.  Where the density of the




    solven.t is equal to one, one mg/1 is equivalent to one part per




    million (ppm) or  one milligram per kilogram (mg/kg).






 Milliliter (ml):  A volume equal to one thousandth  of a liter.






 Nanogram per liter (ng/l): The concentration at which one billionth




    of a gram (one nanogram) is contained in a volume of one liter.




    Where the density of the solvent  is equal to one,  one ng/1 is




    equivalent to one  part per trillion or one nanogram per kilogram



    (ng/kg).






 Neoplastic:  Describing any new and abnormal growth,  such as a tumor.






Part per million (ppm):  A concentration in which one unit is contained



    in a total of a million units.  Any units may be used (e.g.,  weight,




    volume) but in any given application identical units must be used




    (e.g. , grams per million grams  or liters per million liters).




    Where the density of the solvent is one, one part per million is



    equivalent to one milligram per liter.

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                            39
 Parts per thousand (o/oo):  A concentration at which one unit  is
    contained in a total of a thousand units.  The rules for using
    this term are the same as those for parts per million.  Normally.
    this term is used to specify  the salinity of estuarine .or sea waters.

 Piscicide:   A substance used for killing fish.

 Static bioassay: A bioassay in which the toxicant is not renewed during
    the test.

 Thermocline-:  That layer in a body of water where.the  temperature
    difference  is greatest per unit of  depth.  It is the.layer in  which
    the drop in temperature is I  ?:. or greater pet-meter of depth.

 Tl.ni  - Median Tolerance Limit:  The: concentration of  a test matc.rh.I
    at which fifty percent of the test animals are able to survive
    under test conditions  for a specified period of exposure.  It is
    virtually synonymous with LC50 and TL50.

TLF)0: Synonymous with TLm and virtually  synonymous with LC50.

Tumorigenic:  Causing or producing  tumors.

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       40
Appendix     A

-------
                               41

                          NOTICES
                                                      [PRL 278-7; FtFRA Docket Nos. 145 etc.]

                                                         SHELL.CHEMICAL CO.  ET Al_

                                                       Consolidated Aldrin/Dieldrin Hearing

                                                      On August 2,  1974, I Issued my Notice
                                                    of Intent to Suspend the registrations of
                                                    certain  pesticide products  containing
                                                    Aldrln and Dieldrin, After an adjudica-
                                                    tor? hearing,  the Chief Administrative
                                                    Law Judge  of  this  Agency  on Septem-
                                                    ber 20, 1974, issued a recommended deci-
                                                    sion  concerning  the  allegations con-
                                                    tained  in   that  Notice  of  Intent  to
                                                    Suspend. On October 1, 1974,1 Issued my
                                                    Opinion and Order. The three documents
                                                    are published herewith.

                                                      Dated: October 8.1974.

                                                                      RUSSELL E. TRAIN,
                                                                            Administrator.
                                                        • [FJ.F.R.A. Dockets Noa. 145, etc.]
                                                            SHELL CHEMJCAJ. Co. ET .VL.

                                                       NOTICE Of Cn'ENTlOiT TO SUSPEND AND
                                                        JTNDINCS AS TO AN IMMINENT HAZAJU
                                                      In the matter of Shell Chemical Company.
                                                    et aU  Registrants  (Consolidated  Aldrln/
                                                    Dieldrin  Hearing)  F.U.R.A. Dockets  Nos.
                                                    145 etc.
                                                      By this ordef. Issued pursuant  to section
                                                    6(c) of tho Federal Insecticide. Fungicide.
                                                    and RodenUcide Act. 33 amended ("Kli'RA"),
                                                    I am hereby serving notice of my Intent to
                                                    suspend the registrations nnrt  prohibit tho
                                                    production for use  of all pesticide products
                                                    containing Aldrln or Dieldrin which  are sub-
                                                    ject to and for which appeals wero duly filed
                                                    from the Aldriu/Dleldrtn cancellation order
                                                    Issued  by the Administrator of the Environ--
                                                    mental Protection Agency on Juno 26, 1972.'
                                                    This suspension order Is effective within flve
                                                    days unless  the registrants request an ex-
                                                    pedited hearing pursuant to section  6(c) (2),
                                                    with the  added  provision  that I am per-
                                                    mitting, pursuant to  section 15 (b)  (2), use
                                                    or sale of existing formulated stocks of pes-
                                                    ticides containing Aldrln or Dieldrin which,
                                                    are on band as of  tho effective date of tho
                                                    suspension order. Such hearing. If requested.
                                                    shall take no longer-than IS days from tho
                                                    commencement of  the hearing, unless, for
                                                    good cause shown I extend that time for no
                                                    more than 5 additional days
                                                      Background. The history of prior attempts
                                                    to regulate the sale and  use of Aldrln  and
                                                      *In  the  matter of  Seen  Co..  et  al.,
                                                    I.P.&K.  Docket  No.  145  etc..  FJFL.  Vol.
                                                    39,   No.  126.   at  .p.   13304   (published
                                                    June  29,  1972).  For  purposes  of  clarifi-
                                                    cation, the result  of  a final" order  of sus-
                                                    pension will be to  prohibit  tho  manu-
                                                    facture  of  Aldrln  or  Dloldrlu for any  uso
                                                    except for the three uses permitted by  the
                                                    June  28. 1972. order. Those three exempted
                                                    uses are: Restricted termite use, tho  dipping
                                                    of roots and tops of non-food plants and use
                                                    In a total effluent-free mothprooong system.
                                                  S

FEDERAL RJEGISTER. VOL 39,  NO. 203—FRIDAY, OCTOBER  18, 1974.

-------
 D     .a'Is both lengthy and involved. The
•original petition for the  cancellation and
 Immediate  suspension of all uses of Aldrln
 and Dleldrln was filed by the Environmental
 T>elense Fund (HDP) on December  3, 1970.
 Shortly thereafter, on March 18,1971, the Ad-
jnini.tT.-xf.nl- of EPA announced the Issuance-
~of appropriate notices of cancellation  based
 on a ^r.rjtng of "a substantial question as to
 the  safety" ot AldrLa and Dleldrla. At  the
 same time the Administrator concluded that
 current uses of the compounds did not pose
 "an imminent hazard to the public," as that
 standard was Interpreted In that Order, and
 he thus refrained from ordering a suspension
 of the compounds pending completion of  the
 administrative procedure of review provided
 by the governing statute, the Federal Insec-
 ticide.   Fungicide,   and  P-odentlclde  Act
 (PTFRA).  7  U.S.C.  IS 135  et  seq..  since
 amended by  Pub. L. 92-518. 86  Stat. 973,
 Octofc-er  21.  1972  (FIPRA-&mended).  The
 Administrator's failure to suspend the regis-
 trations prompted the filing by EDF of a peti-
 tion for review In tha UjB.  Court of Appeals
 Jot the District of Columbia. A decision was
 Issued  by  the Court  of Appeals on May 6,
 1972. "Environmental Defense Fund v. En-
 vironmental Protection Agency," 465  F.2d.
 828  (1972). In that decision the Court  re-
 manded the record to EPA  for further  re-
 consideration of  tha Issue of suspension. In
 light of the  judicial Interpretation of  the
 power of suspension  enunciated In the  de-
 cision and the recently released Aldrln/Dlel-
 drln  scientific Advisory committee  report.'
 Tha Court specifically called upon EPA to ex-
 plicate the' nature  and extent  of evidence
 available on the carclnogeniclty of  Aldrln/
 Dleldrin.
  On June 23, 1972, upon review of the sci-
 entific  advisory  committee report and  all
 e    • available data the Administrator reaf-
 1    d  the cancellation of nearly all Aldrln/
 Dleldrln products.  In addition,  that  same
 order solicited views from, the general public
 on the question  of  whether any of the can-
 celled uses should  also be suspended. Par-
 ticular emphasis was given  to those methods
 of application and formulation  (Le., aerial
 application and dust formulation) presenting
 the most obvious rls'i of widespread unavoid-
 able dissemination  of the  compounds.
  On  December  7,  1972, the Administrator
 announced that Immediate curtailment of all
 aerial applications, dust formulations and
 use of these products  for fire ant control and
 In moth proofing systems Involving  effluent
 discharge had been achieved through the vol-
 untary cooperation of those  affected Aldrln
 and Dleldrln registrants. The Administrator,
 in response to the Order of the Court of Ap-
 peals,  again re-e.tamlned the Issue  of STIS-
 penslon. Based on a review of the evidence
 available at  that   tlaie  the Administrator
 again  declined to exercise his power of sus-
 pension pending the completion of the hear-
 ing. His decision  was based on the belief that
 the current uses did not present a substantial
 likelihood that serious harm would be  ex-
 perienced during the 12-18  months In which
 the  hearing was expected  to be completed.
  n Busts /or current re-evaluctlon of sus-
 pension. In the  Initial Aldrln/Dleldrin can-
 cellation Order,  former Administrator Wil-
 liam D. Euckelshaus stated then that  the
 Agency would be prepared to re-evaluate  the
 question of suspension at any later stage In
 the  administrative proceedings (March 18th
 Statement. 1971. p.  12).  In this Agency's
 brief to the  U.S. Court of Appeals  for  the
 District of Columbia filed In  response to  the
 earlier EDF appeal on the  Aldrln/Dleldrin
 suspension issue, EPA readily acknowledged
 •'  t:  'The concept of the safety of the prod-
     la  an evolving  one which  la constantly
 .   -ig further refined  In light of our Increas-
                       42
                NOTICES

ing knowledge." Indeed, as the Court of Ap-'
pools emphasized In Its  opinion remanding
the Aldrln/Dleldrln suspension Issue  to this
Agency:  "The  administrative  process Is  a
continuing one. and calls for continuing re-
examination at significant Junctures." "En-
vironmental Defense Fund,  Inc. v. Environ-
mental Protection  Agency."  supra,  citing
"American Airlines. Inc. v. C-A.3.". 359 P. 2d
624  (en bone),  cert  denied  385 U.S.  843
(1966).
  There Is no question but that the current
proceeding Involving the continued registra-
tion and future manufacture  end  use- of
Aldrln/Dleldrin products Is  at a "significant
juncture." It has been estimated that  the
taking of evidence alone In  this hearing will
continue for another  4  or  5  months. This
means that a final Agency decision cannot be
expected until sometime In early 1975. Thus,
the time period for a  final  decision as pro-
jected  by  the  Administrator  In  December
1972 has grown considerably.  Absent this
Order there Is nothing to prevent the manu-
facturer, during the period prior to  a final
decision on cancellation, from producing an
additional  -estimated  10  million or more
pounds of active technical product Aldiin for
anticipated 1975 sales. This will mean that
after formulation of  the technical 'product
over 50 million pounds of  formulated final
products will be available for snle and pos-
sible use over the period of the next year. The
manufacturing process which would produce
the Aldrtri/Dleldrln products for sale and use
In 1975 has been scheduled,  according to the
sole manufacturer. Shell Chemical Company.
to' begin on September 1.  1974. Shell haa re-
fused to delay  voluntarily the manufacture
of these products until  completion  of  the
current cancellation hearing. If after the end
of the cancellation proceeding I decide finally
to prohibit the use of these pesticides and
yet the current manufacturing cycle  Is per-
mitted to be completed, the disposal of such
tremendous amounts of these chemicals will
present enormous environmental risks and
problems,  discussed further  below,  which
must be  anticipated and avoided by this ac-
tion.  Once the-  manufacturing process  Is
completed such risks are Irrevocably created.
  This proceeding Is at a "significant Junc-
ture" In another highly significant sensa In
that an Intense examination of the relevant
evidence over the post year has. brought to
light   certain  previously -unknown  facts,
which  have now been reviewed and scien-
tifically documented for  the first time. On
March 22.  1974, 'this Agency's  OSce  of
Hazardous Materials  Control,  through  the-
OfSce  of  General  Counsel, completed  Its
presentation of evidence both as to the risks
(human,   environmental,   and  economic)
from continued Aldrln/Dleldrln usage,  the
availability of  preferable alternative com-
pounds and the projected economic  conse-
quences of discontinuation.
  It Is clear that a great deal of evidence
was  simply  not available  to  former Ad-
ministrator Ruckelshaus at -the tlma of his
re-evaluatlun  of the  suspension Issue on
December 7, 1072. A brief elaboration of such
evidence Is set  forth below In Section HI of
this Order.  In  addition, one cannot Ignore
events of this summer such  as the necessary
condemnation  of more than  eight  million
Dleldrln  contaminated chickens  (some  of
which accumulated levels  of Dleldrln as high
as 3 ppm In the fat) In the State of  Missis-
sippi. This occurrence highlights a'major
potential  problem which will  continue  to
exist as long as these  persistent, highly fat
soluble compounds  continue  to be used.
While  the  Incident In Mississippi Is unique
In Its staggering proportions, I am informed
that It Is by no means an Isolated Incident
but affects other Industries as well. Whether
these Incidents are a result of  accidents or
 misuse, or whether they are a direct con-
 sequence  of the  Intense agriculture-use on
 feed and food crops, does not of course alle-
 viate the economic consequences which must
 be  borne by  the a£ected  Industry  or . the
 serious potential  risks to public health. In-
 deed, the regular  pattern of such occurrences
 would   seem   to  indicate  that  as  long
 as Aldrln and Dleldrln continue to be used,
 such  continuing  threats  to  the   public
 safety are Inevitable.
   m Evidence in support of  suspension. In
 remanding the suspension  Issue to EPA In
 May of 1972 the Court  of  Appeals, as  pre-
 viously noted,  put  special emphasis  on the
 Issue  of  carclnogeniclty,  asking  EPA to-
 elaborate on the  natura and extent of such
 evidence. "Environmental Defense Fund, Inc.
 v. Environmental Protection Agency," supra.
 at  638. Consequently a  discussion  of  the
 limited evidence  available at  that time, i.e.
 evidence of liver  tumors cause'd by Dleldrln
 In a single strain of mouse, constituted the
 principle  rationale-  supporting  the  Ad-
 ministrator's finding of  a  "risk"  amount-
 Ing to  a "substantial question of safety" but
 not "a  red light requiring Immediate elimina-
 tion of all  dleldrln residues  In the dlet.">
 (December 7, 1972, Order, at 10, fn. 5).  The
 -Administrator did not elaborate further on
 the risks of other  toxic effects nor the Issue of
 benefits or lack thereof.
   I am not required here to make an  exten-
 sive elaboration  with  findings and conclu-
 sions on the multiple Issues Involved  In the
 cancellation  proceeding.  As  the  Court of
 Appeals  observed  In  "Environmental  De-
 fense  Fund T.  Environmental  Protection
 Agency." supra, at 537, "the function  of the
 suspension decision Is to make a preliminary
 assessment  of  evidence,  and probabilities,
 not an ultimate resolution of difficult Issues."
 Thus, I will outline with specificity why the
 best scientific and medical evidence compels
 suspension at this time.
   Specifically, we have learned the following
 pertinent Information:           '  -
   1. Since the 1970 usage of Aldrln, the last
 year for  which  complete use figures were-
 available prior to the Issuance of the Decem-
 ber 1972 Suspension Order, the use of  Aldrln
 has actually Increased  from  8.9 million to
 11.8 million pounds In 1972. Thus, the con-
 tinued decline In use that was anticipated
 at that time has not been realized.  '
   2. For  the most recent reporting period, of
 Fiscal  Tear 1973,  the Food and Drug Admin-
 istration, In Its market basket survey, reports
 that measurable  amounts of Dleldrln were-
 found  In composite samples of 83 percent of
 all  dairy products,  88 percent of all garden
 fruits  (except  tomatoes, green peppers, cu-
 cumbers), 86 percent of all meat, fish,  and
 poultry samples  and In  percentages  which
 range from 12 percent to 42 percent In other
 food composites of grain and cereal products,
 potatoes,  leafy  vegetables, -oils,  fats  and
 shortening, and fruit. In the normal diet tho
 majority of total Dleldrln Intake Is  due to
 tho residues In  calry products,  meat, fish,
 and poultry. While actual Dleldrtn Intake
1 levels  have shown a slight decline  In  tho
 market basket survey for the years 1971  and
 1972, the percentage of major food category
 composites found to contain Dleldrln have
   'It should be- noted prior to discussion of
 the evidence that while Aldrtn use accounts
 for  nearly  95  percent  of  the  total  use-
 of  the two compounds, Aldrtn  la  inown ,
 to  break   down  quite,  rapidly  Into  Its
 metabolite Dleldrln.  Consequently, residues
 found In the  environment  are principally
 Dleldrln residues;  and'  thus the  hazards
 of  Dieldrln are-  generally  focused  upon.
 Occasionally the two are used Interchange-
 ably.
                                   FEDERAL  ROISTER,  VOL 39,  NO. 703—FXIDAY,  OCTOBER  13, 1974

-------
  actually shown a steady Increase during this
  same period.
    In  addition, air monitoring conducted by
  this Agency during the years  1970-72 reveals
  that Dieldrln was detected In over 85 percent
  of the 3.345 air samples taken nationally, so
  that respiration must be considered an addi-
  tional source of human Dleldrln Intake.
    3. It  appears  from recent  data  that  vir-
  tually every Individual la this country has
  Dleldrln stored  In  the body. Based on the
  annual  national  human  monitoring survey
  conducted,  by  this  Agency,  tissue samples
  taken  during  therapeutic  surgery or  at
  autopsy  revealed that In 1970. 96.5 percent
  of all individuals tested had detectable resi-
  dues of  Dleldrln In their adipose tissue, with
  an  average of 0.27 ppra. For  the  year 1971.
  99.5 percent of all those sampled bad detect-
  able amounts that averaged 0.29 pprn.
    4.  Evidence  now  available Indicates  that
  Dieldrln  definitely   causes significant  Li-
  creases of tumors In  two and probably three
  different strains of  mice  tested.  Moreover,
  there  Is  positive evidence of Increased tumor
  Incidence when Dleldren  was  fed la  low
  doeses to two different strains  of rats  as
  well. Many  of  these tumors have been diag-
  nosed unequivocally bv eminent pathologists
  as malignant.  There  Is further positive evi-
  dence at  malignancy based on metastasis to
  other  organs and transplantablllty  Into un-
  treated host animals.  Dleldrln-caused tumors
  in both mice and nu appear at a variety of
  sites  within the body.  Including  the  liver
  lungs, lymphold  tissue,  thyroid, uterus and
  m.immary glands.  These  tumors  have  re-
  sulted  at  highly  statistically  significant
  levels  from dietary dosages as low as 0.1 ppm
  In the diet, which Is the lowest dosage  ever
  tested In any animal species. In short, even
  the  lowest levels of  Dleldrin produced  sig-
  nificant  cancerous effects. Furthermore, the
  evidence Indicates that exposure to Dlsldrln
  for periods as brief as several weeks is suffi-
 cient  to  cause highly significant  carcino-
 genic effects In test animals.
   This evidence Is considerably more exten-
 sive than that  Involving the single strain of
 mouse discussed lu the December 7. 1972. Or-
 der by the Administrator. ThU Is  not to say
 that  a compound should not be considered
 carcinogenic because  the first and  only evi-
 dence of  carclnogesilclty Is based on the re-
 sults of a single experiment la a single strain
 of  one particular test species. Indeed,  such
 evidence  generally raises a substantial ques-
 tion  of safety  requiring commencement of
 cancellation proceedings. Recent observations
 made by  scientists la the World Health Or-
 ganization's  International Age:icv for Cancer
 Research  demonstrate that It Is unlikely that
 a compound shown to be carcinogenic In one
 species will  not  similarly  be  carcinogenic
 when adequately tested In  another test spe-
 cies. The more extensive data which have now
 been   developed  on  the  carclaogcnlclty  of
 Dleldrln confirm and  augment  the  original
 data  from the single strain of mouse. World
 cancer experts who have testified at the can-
 cellation  hearings earlier  this year have con-
 firmed  the very aerlous nature  of this evi-
 dence.
  5. While there  Is no known  way  of  ex-
 trapolating absolute  conclusions from  an'l-
 mals  to man.  we do kaow that  the basic
 overall similarity of the experimental animal
 to  man from the standpoint  of carc'.noge-
 nlclty Is clear In principle. The principle is
 accepted  by  U.S. Government Agencies and
 private health organizations. While rccoer.ls-
 Ing tha fact that exposure to oven the small-
 est  a.T.ouiH of a  carcinogen Is no guarantee of
 absolute  safety, scientists  at  the National
 Cancer Institute- have devised  oue  method
 'or  estimating the degree of cancer rlsi to a
 particular carcinogen.  These ostlrnates are
derived from the animal  cancer  test results.
                    43

                   NOTICES

  Baaed upon these calculations and the neces-
  sary assumptions, the present estimated aver-
  age  human daily dietary Irs'.aie of Dleldrln
  subjects the  human  population to an  ex-
  tremely high cancer risk.
    6.  While most  or the data with respect to
  the estimated dally Intake or Aldrirs/Dleldrln
  are computed on ac  average basis.  It Is  ob-
  vious that  based on  differences  In dietary
  composition  somo segments of the popula-
  tion  will greatly exceed  that average.  In
  fact,  we have now learned from a  national
  dietary survey that young children,  particu-
  larly  Infants from birth to one year of age
  because of  their high dairy  product diets.
  consume considerably  more Dleidrln  on  a
  body-weight  basis than any other  age seg-
  ment of our  population. Evidence from lab-
  oratory  experiments with test animals has
  shown that the newborn Is generally  more
  sensitive to carcinogens.  Therefore. Infanta
  exposed  to Dleldrln  may  be subjected to  a
  considerably   Increased risk.  It  has  been
  shown that In humans Dleldrln Is transferred
  to the fetus during pregnancy. Thus exposure
  to  Dleldrln  begins at  the earliest stages of
  life.
   7. Evidence  based upon  human sublects Is
  virtually  Impossible  to obtain. The general
  human population Is continually exposed to
  a  multiplicity  of chemicals.  A  significant
  "control group" Is thus Impossible to estab-
  lish. Moreover, to await the  twenty to thirty
  years of  exposure  necessary to determine the
  ultimate effect Is only to wait until the dam-
  age  to an entire generation of  humans !s
  complete. We  reject tho-"bod7 count" ap-
  proach to protection against cancer or other
  such  long term threats to public health. Pre-
•  diction based  on  laboratory testing  Is  thus
  necessary and unavoidable il  public health
  Is to be protected.
   8. There are additional  serious questions
  as to other tox!cologtcal effects demonstrated
 by these compounds which have a  bearing on
 further  human  and   environmental  risks.
•These  Include, birth defects caused by Aldrin
 and Dleldrln In hamsters  and mice-,  adverse
 etfecta on learning capabilities In monkeys
 fed low levels of Dleldrln,  adverse reproduc-
 tive effects caused by  Dleldrln la male and
 female dogs and mice  and evidence showing
 the danger posed to endangered species such
 as the bald engle.
  9. Finally,  there Is  no agricultural neces-
sity for the major use  of these compounds.
It Is estimated that more than 90  percent of
the  total usage of Aldrtn and Dleldrtn Is on
com.  According to the most recently pub-
lished U.S. Department of Agriculture statis-
tics, less  than  10  percent of the total  corn
grain producing acreage In  the United States
Is treated with these  compounds. On  the
acreage where Aldrln  Is used, there  are  en-
vironmentally   preferable substitute  pesti-
cides,  alternative means of pest control or
promising substitutes awaiting Federal reg-
istration.
  The number  ot additional uses which are
actually bel:ig  defended In  the  hearing Is
quite  small. For most  of these  minor  uses
there  also are  alternative  pesticides  which
can  be utilized. In a  few specific  Instances
of very minor  uses,  there  may  be no  reg-
istered  alternatives at  this time.  However.
the provision of this suspension order  per-
mitting continued use of already formulated
Aldrln nr.d Dleldrln products will give some
tlmo  for  the  registration of  promising en-
vironmentally  tolerable- alternatives,  where
registrations do not already exist.
  As was  stated by a subgroup  within the
U.S.  Department  of  Agriculture  review!:'»
Aldrln/Dleldrln residues In  food and feed as
far back as December.  1953:
  It  is  pertinent  to cote ar. experience of
about  >en years ago when It was'clearly de-
termined'by residue studies  that nldrln. dlel-
   drln. and heptachlor could no longer be pe--
   nlttad  to control grasshoppers on  western
   raagelaad because of meat residue problems
   The search for nor.perslstent alternative In-
   secticides  was stimulated  and  an elective
   organophosphorous  Insecticide  was  found.
   Thus, a  serious  food  safety problem was
   eliminated. Agriculture la general would not
   suffer if aldrin-dleldrin were eliminated from
   use on agricultural croas.
    Having reviewed the above stated pertinent
   factual  data  as  well as  all other available
   pertinent data,  I am persuaded that  there
   exists an  "imminent  hazard"  within the
   meaning of'the statute (as defined  by sec-
   tion 2(e)  of the FIFP.A). It should be noted
   that  during late  1973 and early  1974 the
  Agency  star? presented Its evidence  on the
  cai-clnogenlclty of Dleldrln. During this time
  the manufacturer, through counsel,  had Its
  full  resources available for extensive  cross
  examination of witnesses. The manufacturer
  has completed the presentation of most of Its
  evtder.ee on other aspects of the case. While
  earlier this year It was anticipated that the
  responsive evidence on carc'.r.ogenic'.ty would
  have  already  been completed. It  cow ap-
  pears that this  evidence win be presented
  during September and October of this  vear.
  The cancer experts with whom we have "con-
  sulted advise us that the  rebuttal evidence
  thus far proffered  by  Shell  Is unlikely to be
  persuasive.  Further   assessment  of   the
  substantiality  of this evidence can be made
  at  the expedited  hearing,  Lf the registrants
  recuiest such a hearing.
   IV Effect of order and considerations given
  thereto.  I  flnd that In light of the evidence
  abovo and because of the time this hearing
  will take In the future, a situation ex-.sts In
  which the manuracuire of  A'.drln and Dlel-
  drln during the coming months-s-il! be "I'.kely
  to result In unreasonable adverse ertect-s" on
  man  and the environment.5 In consultation
  with   the   sole  macafacturer  cf  Aldrln/
  Dleidrln, the- Shell Chemical Company, and
  Its  fomvulators,  a determination'  shall  be
  made  as to the precise extent of  formulated
  products currently on  hand  as of  the date of
  this order. Any  stocks of  technical grade
  Aldrln and  Dieldrln which have not already
  been,   formulated   Into  products  may   not
  henceforth  be  formulated  for use  in  any
  product other  than those uses exempted  In
  the June 26, 1972 order as coiiflrrr.ed  In  the •
 December 7. i972  order.
   This Agency  is  not  unawars that certain
 particular uses of pesticides can result  in a
 greater likelihood of unreasonable  adverse ef-
 fects on the environment than others. Such a
 distinction,  however.  Is particularly dLf.cult
 to make  wl:h  respect  to  the  compounds
 A'.drln/Dteldrtn. which are so highly persist-
 ent, mobile, lipld soluble  and capable  of ex-
 erting  such a  broad  range  of  toxic eSects.
 Therefore, this  order  effects all those regis-
 tered  uses for which appeals were dujy filed
 Trom the. June 26,  1972 order (see  footnote 1
 above).
   Finally.  I have Invoked  the new  "Special
 Rule."  provision of section  15(b) (2)  per-
 mitting continued use   of  those  existing
 stocks  of   formulated,  federally  registered
 products containing Aldrln or Dlcldrin. It is
 held by many of those who have Investigated
 the  potential risks  and problems  attendant
 to the disposal of consolidated stocks of some
 toxic materials,  such as these pesticides, th.it
 It may well t>e sa-fer environmentally to dis-
 pose of them through  normal us« patterns
  ' As further defined  by the statute, section
2(bb). the  term "unreasonable adverse ef-
fects on  the environment" can Include  "any
unreasonable risk to man or the er.vl'or.rr.ent
taking into account the economic, svclal. and
environmental  costs and benefits of :he use
of any pesticide."
                                  fEDE.IAL  REGISTER, VOL  39, NO.  203—FRIDAY,  OC7C3E3  13,  1974

-------
                                                                 44

                                                              NOTICES
 th __ L to atumpt to retrieve the product from
 tha retailer or mer. and then to transport.
 consolidate and either bury or burn remain-
 ing supplies.  Absent Invoking the  "Special
 Sola", this latt«sr  alternative  la what  would
 '  • required as present with existing formu-
 .aiad stocks.  Additionally. It  is  my under-
 standing thai corn farmers have  already ap-
 plied. Aldrin  this past spring, so that there
 remains only limited usage on minor crops
• during the remainder of the  current  grow-
 ing seasons. Permitting use of  existing  stocks
 In these situations will not  penalize farmers
 who have alread7  purchased the  compounds
 with the erpec'.-.t'.on of using them during
 the remainder oi :he growing season.
   Accordingly. I  Intend  to order  the sus-
 pension of  toe registrations and prohibit the
 production for use of all pesticide products
 containing Aldrin or Dieldrin  which were
 subject  to  and for which appeals were duly
 filed from  the Aldrln/DIeldrln cancellation
 order Issued by the Administrator of the En-
 vironmental Protection Agency on June 26,
 1972 (see footnote 1, above). In the absence
 of a request  for an  expedited hearing, this
 order shall b» effective S days after receipt
 by affected registrants.

   Dated: August 2. 1974.

                      Russru. E.  TRAIN.
                           Administrator.

       [FTFRA Dockets No. .146. etc.)
     SHTT.T.  CTTKMTCAL COMPANT.  ET AI..

                  STATEMENT BZGAKOrNG
                         DECISION
   These are consolidated  proceedings  under
 the  Federal  Insecticide.  Fungicide,  and
 Rodentlclde Act.  as  amended (7 U.S.C. 133
 e'  i., 1973 Supp.). Pursuant to section 6(c)
 c    ;  act  (7 U.S.C.- 136d(c)>. the Admlnls-
 tic..or.  on August 2,  1G74. Issued a notice of
 Intention "to suspend the registrations and
 prohibit the production for use of all  pesti-
 cide produces containing  Aldrln  or Dieldrin
 which  are subject to and for which appeals
 were duly  Sled  from  the Aldrln/DIeldrln
 cancellation order Issued  by  the Adminis-
 trator  of  tbe  Environmental  Protection
 Age=cy on June  23.  1972." > The notice  of
 suspension also contained detailed findings
 pertaining  to  the  question of  "Imminent
 hazard" as required by the act.3
 "Unreasonable adverse effects on the environ-
 ment"  is denned in the act to mean "any un-
 reasonable  rlslc  to man or the environment.
   1 As explained In the August 2.  1974  no-
 tice,  a final  order of suspension  In  these
 consolidated proceedings would not Include
 the 3 uses permitted by the .June 26, 1972
 order, that  Is, restricted termite  use,  the
 dipping of roots and tops of nonfood plants
 and use In a totally effluent-free mothproof-
 Ing system. Also, the August 2, 1074 notice of
 suspension  permitted, pursuant to section
 15(b)(2)  of the act (7 U.S.C.  136m(b)(2»
 the "use or sale of existing formulated stocks
 of pesticides containing Aldrln or Dieldrin
 which were on hand as of tbe  effective date
 of the suspension order."
   'Section S(c)(l)  of the act provides that
 '"! '.tie Administrator determines that action
 '3 ncressary  to prevent an Imminent hazard
 i-.;rir\s the tim? required for cancellation or
 :hnnse in clruai'cation proceedings, he may.
 br order, suspend  the registration of  the
 p*c!!clde  Irr.rr.sdlately." The term "Imminent
 j-.^'.ard" Is de:'::ied to mean. In part, "u s-.tua-
 '.Icti  which exists when the continued use of
 a  nestlctde  during  the time  required  for
 c    llatlon proceeding would be  likely to
 r>    .  In unreasonable  adverse effects on
 its environment	(7 U.S.C. 136(1)).
taStlng Into account the economic, social, and
environmental costs and benefits of any use
of any pesticide." (7 TJ.S.C. 138(bb)).
  Shell Chemical Company,  the sole manu-
facturer of  the pesticides  Involved,  filed
timely objections to the notice of  Intention
to suspend and subsequently 22 other regis-
trants also filed objections thereto.' In addi-
tion,  the  Secretary of  Agriculture  of  the
United States, Environmental Defense Fund,
Inc..  the  National  Audubon  Society,  and
Florida Citrus Mutual were granted leave to
Intervene herein pursuant to 3 lS4.121(e) of
the rules of practice (38 FR 19371, 19378).
  Section S(c) (l) of the statute further pror
Tides  that "No  order of suspension may be
Issued unless  the Administrator has Issued or
at the same time Issues notice of hla Inten-
tion to cancel the registration or change the
classification  of the  pesticide." By PR  No-
tice 71-4.  da-.cd March 18. 1971, and Issued
by the Acting Director of the then Pesticides
Regulation Division, after  prior piecemeal
cancellations  of registrations of pesticides
containing the  Insecticides aldrln  and  dlel-
drtn.  the registrations  under ths act of all
registrations  of products  containing aldrln
and  dleldrln  were  cancelled. Of  the  88
registrants who. In effect',  appealed the can-
cellation of their registrations by PR Notice
71-4,  2 requested a public  hearing  and 84
registrants requested that  the  matter  be
referred  to an  advisory committee selected
by the National Academy of Sciences, which
they  could then do under the statute.  The
cancellations  Involved  were  not  effective
pending the outcome of such appeals.  The
Al-lrLn/Dleldrln Advisory Committee to the
Administrator Issued a report March 23,1972,
recommending,  In part, that certain uses of
the. pesticides Involved be disallowed, that
enumerated uses thereof are "valuable  and
not harmful." that  further  studies be con-
ducted In  specified areas and that a further
review be conducted In the future.

  By  a  Determination  and  Order  dated
June  26, 1972. then required by the statxite,
the Admlnlatrfator aSnned the cancellation
of the registrations of all products containing
aldrln or dleldrln except with respect to those
registered uses Involving the  dipping of roots
or tops of nonfood plants, subsurface ground
Insertions for termite control  and mothproof-
ing by manufacturing processes which utilize
the pesticide  In a closed system, which uses
the Administrator found to "pose de minimus
risks." The Administrator therein  deferred
decision  on the suspension, as distinguished
from  the  cancellation,  of  the  aldrln  and
dleldrln registrations.
  Section 4c  of the act (7  TJ.S.C. 135b(c))
then  provided  that administrative  appeals
from  the decision of  the Administrator to
maintain cancellations In effect may be t_ken
within 60  days  from  the date of such deci-
sion.  Appeals  therefrom were taken by the
ftllng of objections thereto and request for
a public hearing by 38 registrants.
  The Administrator,  by  a  Determination
and Order dated December 7.  1972, In part,
consolidated  Into  the cancellation proceed-
ings petitions dealing with tolerances of al-
drln and dleldrln pursuant. In effect, to sec-
tions  406 and  40<< of the Federal Food. Drug,
and Cosmetic Act (21  TJ.S.r. 348 and 340a).
The Administrator also therein declined to
suspend  the registrations  lr -olved.  clarified
his prior order with respect :o permitted uses
  > It Is not clear that ail of  the additional
legist rein ts flied  timely  objections and are
properly parties to these proceedings. How-
ever, respondent has failed to  file motions to
dismiss In this regard  and we are  not  In
possession of the facts to enable us  to decide
this Issue.
and.  In effect,  lifted the  cancellations of
registrations  for  manufacturing use  only.
Oral hearing In the cancellation proceedings
commenced August 7. 1973, and was In prog-
ress when the notice of Intention to suspend
was Issued.*
   On  August 7. 1974°. Herbert L. Perlman,
Chief  Administrative Law  Judge, Environ-
mental Protectlor Agency, was appointed the
Presiding Officer In the suspension proceed-
ings. Prehcartng conferences were held Au-
gust  7. 8, 9 and 13. 1974,  and the hearing
herein commenced  August 14. 1974. The reg-
istrants filing objections to the notice of In-
tention to suspend subsequent to the filing of
objections by the Shell Chemical Company
were consolidated Into the  proceeding Insti-
tuted by Shell pursuant to I 164.121 (f) of the
rules of practice and evidence- received In
the  cancellation proceedings  was Incorpo-
rated by reference  Into the suspension  pro-
ceedings by the agreement of the parties. In
addition, respondent did not  present  evi-
dence herein with  respect  to the matters
contained In paragraph 3 of the August  2,
1974 notice of Intention  to  suspend dealing
with  tozlcologlcal effects  of aldrln and dlel-
drln other than cancer, and ganger nosed to
endangered species.
   The Administrator ordered .that the hear-
ing herein  take  no longer  than- 15 hearing
days  and the hearing closed September ' 12.
1974. The active participants ac the hearing
were represented by tbe following:
   William D. Rogers, Andrew  3. Srulwtch.
David H. Lloyd and Linda Blumenfeld, At-
torneys  at  Law.  Washington,  D.C., repre-
senting Shell Chemical Company,
   Raymond  W.  Fullerton  and  Richard S.
Wasserstrom, Office  of the  General Counsel,
United States Department of Agriculture,
representing Interveoor  Secretary of  Agri-
culture of the United States; and  John A.
Knebel. General  Counsel, United States De-
partment of Agriculture,  who presented one
witness and made  oral  argument  for  this
Intervenor.
   William A: Butler and Jacqueline M.  War-
ren, Attorneys at Law, Washington. D.C.. rep-
resenting  Intervenors Environmental  De-
fense Fund. Inc. and the National Audubon
Society, and
   John C.  KoloJesSU. William  E.  P.euiauf,
Timothy L. Barker. Edward Lyle, and  John
W..Lyon. Office of tbe General Counsel, En-
vironmental Protection  Agency, represent-
ing respondent Assistant  Administrator, En-
vironmental Protection Agency.
   Subsequent to the close of hearing- the par-
ties filed briefs and  I hereby submit my rec-
ommended  decision  within  the exceedingly
short period of time provided by the rules of
practice.

             FINDINGS OF FACT

   1. The  registrants In these  consolidated
suspension proceedings are as follows:

Agway Inc.. a corporation whose address Is
   Box 1333, Syracuse, New York;
AMOCO Oil Company, a  corporation whose
   address Is 200 East Randolph Drive.  Chi-
   cago, Illinois:
Arlenge  Laboratories,  Inc..  a corporation
   whose address Is 175 Pearl S'v-it. Brooklyn.
   New Tort;
Borden, Inc..*a corporation  whose address Is
  60 West Broad Street, P.O. Box 2478, Colum-
   bus, Ohio;
  4 By August  2, 1974. over 24.000 pages of
tit; iscrlpt and many thousand of pages of'ex-
hibits. Including the witnesses' direct testi-
mony, were adduced In, the consolidated can-
cellation proceedings.
                                   FEDERAL REGISTER,  VOL  39,  NO. 203—FRIDAY, OCTOBER  13, 1974

-------
                                                                      45
   Borderland  Products.  Inc..  a  corporation
     whose address Is 560 Fulton Street,  P.O.
     Box 368, Buffalo, New Tori:
   Bonlda Chemical Company. Inc.. a  corpora-
     tion whose address Is Utlca,  New Tort:
   C. J. Martin Company, a company whose ad-
    dress 13  606  West  Main Street,  P.O.  Box
     1089. Nacogdoches. Texas;
   Chevron  Chemical  Company,  a  company
    whose address is  200  Bush street,  Saa
    Francisco. California:
   Coastal  Chemical  Corporation,  a  corpora-
    tion whose address Is  Evans Street.  Ex-
    tension,  P.O.  Box  856, Greenville,  North
    Carolina;
   Colorado International Corp.,  a corporation
    whose  address Is 5321 Dahlia Street. Com,.
  . merco City, Colorado;
  Dexol Industries, a company whose address
    Is  1450 West  228th  Street. Torrance, Cali-
    fornia;
  Farmland  Industries.  Inc..  a corporation
    whose  address  Is P.O.  Box  7305, Kansas
    City. Missouri;
  FCX Inc..  a corporation  whose address la
    P.O. Box  2419, Raleigh, North Carolina.
  Helena Chemical  Company (Mldsouth Dlvl-
 :  slon),  a  company  whose  address Is P.O.
    Box "N",  West Helena. Arkansas:
  Key  Laboratories. Inc..  a  corporation whose
 :  address b  Bosklns  Crossing. Largo, Flor-
    ida;
 •' McLaughlln Gormley King Company, a com-
   pany  whose  address Is 1715  S.E.  Firth
    Street,  Minneapolis, Minnesota:
  Riverside Chemical  Company,  a company
   whose address la P.O. Box 17119. Memphis.
   Tennessee:
  Shell Chemical Company, a division  of Shell
   OU  Company, a  corporation, whose  ad-
    dress  Is  2401  Crow  Canyon Road.  Saa
   Ramon, California;
   '•>uthern Agricultural Insecticides.  Inc., a
   corporation whose address Is  P.O. Box 218
   Palmetto, Florid a;
  Etauffer  Chemical  Company,  a  company
   whose address Is  1200 South 47th Street,
   Richmond, California;
 .Stephenson Chemical  Company, Inc., a cor-
   poration  whose  address  Is  P.O. Box 87188.
   College Park, Georgia;
  Stevens Industries. Inc., a  corporation whose
 1  address Is Dawson. Georgia: and
 I Triangle  Chemical  Company,  a  company
 |  whose address Is P.O. Box 4528, 206 Lower
 I  Elm Street, Macon, Georgia.
 I  2. The  tntervenors  In these  consolidated
 | suspension  proceedings are the Secretary of
 j Agriculture  of the United States.- Environ-
  mental    Defense   Fund,  Inc.,  National
  Audubon  Society, and  Florida Citrus Mutual.
 .The  respondent  herein  Is   the  Assistant
  Administrator,  Environmental  Protection
 . Agency.
   3. Aldrln  Is the common name of a chemi-
• cal  compound approved by the International
  Organization  for Standardization (except In
  Canada, Denmark and U.S.S.R.) and by the
  British Standards Institution  for a material
  containing not less than 95 percent of 1,8,9,
  10.11.11-hexachloro-2.3-7,  6-endo-2.7.8-exo-
  tetracyclo [8.2.1.1»-«.0"]  dodec-i.9-dlene.  In
  Canada, aldrln refers to trie pure compound.
  known as HHTJN In Great Britain. It  was In-
  troduced  In the United States In  1948  by
  Julius Hyman and Company as Compound
  118 under the trademark Octalene. In  Decem-
  ber 1949. the  Insecticide was given the com-
  mon  name   "a'.drln"  by  the   Interdepart-
  mental  Committee on Pest  Control of the
  United  States Department of  Agriculture.
  It has been used as a broad spectrum In-
  secticide on a variety of crops aad In a wide
  variety  of locations  and situations.  Its In-
  Bectlcldal  action was flrst described by Llclon
  •xnder patent number 2.635,977  (this was
   ansferred  to S.hell Development Company
   i 1963), and Schmerllng had patent number
                  NOTICES

  3.911.477  (transferred to Universal OU Prod-
  ucts In. 1959). Tho physical properties of the
  compound are as follows:
    (a)  As a  pure compound. It Is a white
  crystalline odorless solid,  with a  molecular
  weight of 364.93.
    (b)  It  has a  melting point of 104-104.5'
  Centigrade.
    (c)  Its vapor pressure Is 2.3U10-»mm of
  Mercury at 20' Centigrade.
    (d)  It is  slightly soluble In water (0.0037
  mg/100 ml  or 2.7x10-* grams per 100 mllLl-
  llters of  water).
    (e)  It  Is  llpophlllc, having a strong  at-
  traction for fats, and Is fat soluble.
    (f)  Its  colublllty In various substances Is
  as follows:
    Pentane—3 grams per  100  mllllllters at
  25'C.
   Ethanol—5 grams per  100  mllllllters at
  25'C.
   n-Butonol—9  grams per  100 mllllllters at
  25'C.
   Butanone—24 grams per  100 mllllllters at
  25'C.
   Amylacetate—30 grams per 100 mlllllKers
  at 2S'C.
   Acetone—68 grams  per  100  mllllllters at
  25'C.
   Benzene—83 grams  per  100 mllllllters at
  25' C.
   Xylene—92 grams per 100  mllllllters at
  25'C.
   Ethylenedlchlorlde—105 grams per 100 mll-
 1111 ters at 25'C.
   Carbon  Tetrachlorlde-M05 grams per  100
 mllllllters at 25'C.
   (g)  It Is stable In the presence of organic
 and Inorganic alkalies.
   (h)  Oxidizing  agents and strong adds at-
 tack the unchlorlnated ring.
   (1) Upon prolonged storage, there Is a alow
 formation of Hydrochloric  acid (HC1) which
 causes  It to be corrosive.
   (J) The technical product Is a tan to dark
 brown  solid with  a melting range  of about
 49 to 60«C.
   (k)  It Is a  non-systemic and persistent In-
 secticide.
   4. Dleldrln, a  manufactured  product and
 a metabolic degradation product of  aldrln. Is
Hhe common  name approved by the Interna-
 tional Organization for Standardization (ex-
 cept In Canada.  Denmark and the  U.S.S.R.)
 and by the British Standards Institution for
 a material containing  not  less  than 85 per-
 cent of  1.8.9.10.11.11-hexachloro-4.5 - exo-
 epoxy-2.3-7,8-endo-2,l - 7.8 - exo - tetracyclo
 [ 6.2.1.l.'-«.0=-'] dodec-9-ene. In Canada dlel-
 drln refers to the pure compound, known as
 HEOD In  Great Britain. It Is used as a broad
 spectrum Insecticide and was first Introduced
 In 1948 by Julius Hyman  and Company as
 Compound 497 under the trade name of Acta-
 lox. In' December,  the Insecticide  was  as-
 signed  the common  name "dleldrln"  by  the
 Interdepartmental Committee on Pest Con-
 trol. It Is classified  as a  non-systemic and
 persistent  Insecticide of high  contact  and -
 stomach activity  to most Insects. U.S. patents
 were granted  to Soloway with the patent reg-
 istration number of 2.676,131. This was trans-
 ferred to the Shell Development Company In
 1954. Another U.S. patent  was Issued to a
 Payne and Smith, patent number  2.776,301
 which was transferred to Shell Development
 Company In 1957.  A British patent number
 794.373. was  assigned to N.  V. Bataa'sche  In
 1958. Some of the physical  properties are  as
 follows:
   (a) The pure compound !s a white odorless
 crystalline solid with a molecular weight o(
 380.93.
   (b) Its melting  point  Is  175-176'  Centi-
 grade.
   (c) Its  vapor pressure Is 1.78x10-'  milli-
 meters  Of mercury  (Hg) at 20' Centigrade.
    (d)  It Is llpophlllc, has a strong attraction
 to fats, and Is fat soluble.
    (e)  Its solubility in  various substances is
 as follows:
    Oil.  Standard No. 10—1.3 grams per mllll-
 llter at 30' C.
   Hexane—2.5  grams per mllliuter at 30'  C.
   Methanol—3.4 grams  per mllllllter at 30' C.
   Acetone—35.4 grams per mllllllter  at 30' C.
   Benzene—38.9 grams per mlllillter at 30' C.
   (f)  It  la slightly soluble la water.  0.188
 milligrams In 100 mllllllters of water to say
 It In another  way, 1.88XH) —«g/loo ml.
   (g)  Dleldrln  Is more  stable than aldrln  as
 Indicated  by Its stability when exposed  or
 combined with  alkali and mild acids.
   (h)  The technical product Is buff  to light
 brown  aake»  with a setting  point not below
 95' C.
   5. Beginning In 1950.  Shell Chemical Com-
 pany became  the sole national distributor for
 aldrln  and dleldrtn and Julius flyman and
 Company  remained the sole manufacturer.
 In May, 1952, Julius Hyman and Company
 was amalgamated with Shell  as the Julius
 Hymau and   Company Division  of  Shell
 Chemical Corporation. From 1952 until 1967.
 Shell sold only technical aldrin and dteldrln
 to  pesticide  formulators who In turn made
 It up Into emulslble concentrate, dust, wet-
 table powder or granular formulations  for
 sale under their own company's brand name.
 Beginning In  1967,  Shell started selling for-
 mulated  product   under   the Shell  brand
 name.  By  1972. only 11  percent of the  total
 aldrln  and dleldrln sold was sold as  techni-
 cal  product  for use  In non-Shell  branded
 formulations.
   6. Aldrln and dleldrln are toxic to humans.
 In the  Instance of aldrln,  poisoning  may oc-
 cur by uigestlon.  Inhalation,  and/or  skin
 absorption. Severe symptoms may result from
 Ingestlon or percutaneous absorption of 1  to
 3  grams,  especially In the presence of liver
 disease. Renal damage,  tremors, ataxla. con-
 vulsions  followed   by   C.N.S.  depression.
 respiratory failure and death can occur from
 acute  exposures. Chronic  exposures  over a
 prolonged  period may cause  at least hepatic
 or liver damage.
  7. (a) Approximately  1.5 million  pounds
 of aldrln  were sold In 1950.  the year It was
 Introduced, practically all of this for use  on
 cotton.  Sales  for use on  cotton continued to
 account for   a  major portion  of  the total
 aldrin sales until the mld-1950's when  the
 superior effectiveness of dleldrln against the
 boll weevil became  widely  known. Sales for
 use on  cotton, particularly In the southeast,
 where quick effectiveness between  the many
 ra.m showers  Is a necessity, continued until
 the  mld-1960's.  In  1954,  cotton accounted
 for 30 percent of the total sales whereas In
 1963. the last year  of any  real cotton use.
 It was less than l percent.
  (b) Two ounces of aldrln per acre diluted
 In dlesel oil was an effective and economical
 grasshopper Insecticide  and  It waa adopted
 for all Federal cooperative  grasshopper con-
 trol programs. By 1954 approximately 4  mil-
 lion acres had  been treated  with   aldrla.
 Aldrln remained the Insecticide of choice un-
 til the late 1950's when dleldrln at 0.5 ounce
 per acre became the Insecticide of  choice
 and was used  until  the  mld-1960:s. In 1954.
 use  for grasshopper control  programs ac-
 counted for approximately 16 percent  of total
 sales but  decreased to less than 1  percent
 In the early  1960's.  In addition to the use
cf aldrln In the Federal  grasshopper  control
 programs, substantial quantities' of  aldrln
 (and dleldrLi)  were sold  for use  In other
Federally-sponsored  programs from  1954  to
the late 1960'3. These Included eradication
programs  for  Japanese  beetle, European
chafer,  white  fringed  beetle, and Imported
Fire Ants.  Beginning  In   the late   1950's,
                                   FEDERAL »EGISTSR,  VOL  39,  NO. 203—FRIDAY.  OCTOBER  18,  1974

-------
                                                                       46
                                                              NOTICES
     Irln became the compound of choice for
     >t these  programs, but some aldrtn was
 —jttnued (or the Japanese beetle programs.
   (c)   Other early uses which accounted for
 substantial quantities of aldiln. and later
 were determined to lead to high residue In
 .'oods and  their by-products, sometimes used
 as •vnirnAi feeds,  were soil  applications on
 land planted to potatoes, peanuts and sugar
 beets. In 1354, these uses  accounted for ap-
 proximately 13 percent of the total used. The
 total  pounds used  annually remained fairly
 constant at approximately one-half million
 pounds  through  1082.  Soil use  on potatoes
 and peanuts wsi withdrawn In 1983 but use
 on sugar beets continued until 1987.
   (d)  Until  l.tjS. cotton  was the  principal
 use crop for aldrln. Corn soil usage took the
 lead  that year ana has been the main single
 use since.. A3 of 1071. the estimates showed
 that corn soli usage accounted for 80 percent
 of the total sales for this product. .Other end
 uses, and their percent of the total were  as
tollows:  Termite and  PCO. 14 percent; rice
 seed  treatment, 3  percent: citrus soil use.  1
 percent; other small grains, corn and vegeta-
 ble seed treatments, 1  percent;  and miscel-
 laneous soil applications Including on tobac-
 co, vegetables. strawberrlM, 1 percent. Some
 of the principal end uses of  aldrln for 1954.
 1S«4. 1968 and 1971 were as follows:
      AU>»D» Esi> TJas ESTUIATU—ItXO Las.
                       1954  I9W   1983   1971
 Cotton (foliage)	 834    10
 Com (soil)	 SCH 10.191 12.0S) 9.410
 Orasihoppen	 476    ?0	
 Potatoes (sell)	 239	
 Peanuts	  SI 	 I.
 Citrus (soil);	   JS    ICO   Jio
   •v b«tj	   60	
     treat (eicept rice)	   8    SO    110   130
     3«d treatment	  233    472   2S3
   ^n«5« beetle	   13 .,„.. ...
 WMle-rringeu beetle	  10	,
The end  use estimate of aldrln  under com
Is 8.8.  6.9  and  7.6  million  pounds  during
1972. 1973 ond 1974. respectively.
   (e) A-contlnued gradual decline In  aldrtn
sales In the future may  occur as corn root-
worm resistance moves  eastward through
Indiana and Ohio. Also seed corn maggot re-
sistance to aldrln may also spread outside
tho  lowa-niraols area Into other corn-pro-
ducing  states.
  8. (a)' Dleldrtn was first used  as a spray
or dust on cotton for boll weevil control. Be-
cause of  Its effectiveness against  all cotton
pests except the-  lepldopterous species,  It was
widely  used  In  Texas and  the  Mississippi
Delta area.  Dleldrln  reo.ulred  fewer  appli-
cations because  of  Its residual effectiveness
and was applied every seven to ten days as
tho Infestations warranted. Practically all of
the  1051  Kales of dleldrln were for use on
cotton. This use peaked In 1955 when slightly
more than one million-pounds were sold for
cotton Insect control. The boll weevil became
resistant  to all  chlorinated  Insecticides In
tbe  late 1950's,  and only minor quantities
were sold In the  1980's.
  (b) Forage crop uses, particularly for al-
falfa  weevil control when this Insect moved
Into  tho  northeastern  United  States,  ac-
counted for approximately one million acres
being treated annually during the mid to
late 195O's and early 1960's. Armyrrorm. which
attach  sporadically,  accounted  foi1 several
 million acres  of  small grains  being  treited,
 la tie iildwest In  the early 1980's. Dleldrln
 as well as aldrln was used In tie  Federal
 grasshopper control programs until the mld-
 1900's. Other forage crop pests of lesser Im-
 portance which were controlled, by foliage ap-
 plications of dleldrln  were chinch bugs and
 grasshoppers attacking corn and small grains
 and  the pale Western cutworm,  which at-
 tacked small grains In the Rocky Mountain
 states area.
   (c) Dleldrln was also very effective against
 houseflles and mosquitoes until these pesta
 became resistant. It was also effective against
 deer flies, sand flies,  black  flies  and many
 other public health pests which were Injuri-
 ous and annoying to man and animals. Dur-
 ing tha 1950's  and Into the 1960's. dleldrln
 was used both by Individuals as veil as s-late
 and  local agencies  to control  these pests.
 Theso uses led to high  residues of dleldrln.
 In some aquatic environments.
   (d) Late la the 1950's. It was found that
 dleldrln  was  a very  effective  material to
 pennaatntly  mothproof woolen seeds, par-
 ticularly carpets. If used In the hot acid dye
 bath, dleldrtn  would be taken Into the wool
 fiber and "locked", mto the nber. Alter regis-
 tration was granted, many of the woolen mills
 In the United States started using dleldrln.
 Approximately 250 thousand pounds of dlel-
 drln were used annually until Shell Chemical
 Company withdrew the registration In 1970
 when It was determined that some dleldrtn
 would remain In the dye bath effluent which
 wus discharged Into streams and rivers.
   (e) As wtth  aldrln, government-sponsored
 «• adlcatlon programs  for  Japanese  beetle.
 ^hlte-frlnged  beetle. Euroc"»n  chafer. Im-
 ported flre ants and alfalfa snout beet;?, too*
 constdemb'.e quantities of dleldrtn  from tbe
 mld-1950's through the late 19SCT3. Probably
 the  blggrst program was for whlte-f ringed
 beetle where usage  has averaged more than
 10O thousand pounds annually since 1955.
   (f ) The overall use of dleldrln has dropped
 from a peak of 3.8 million pounds  la 1958 to
 approximately  600 thousand  pounds today.
 As of 1971. the end use sales estimates showed
 the following percent of the total  sales for
 the following uses: Termites and PCO, 44 per-
 cent; fruit (foliage). 2O percent; seed  treat-
 ment. 14 percent: vegetables. 13 percent; and
 miscellaneous  uses  Including  on  to"bacco.
 sweet potatoes, etc.. 9 percent. Sales volumes
 for 1954. 1964. 1968 and 1971 for- some of the
 principal end  uses at  that  point In time
 were as follows:
             END USE
                                   Las
                                Tear
Tor

1MO." 	
19.M. 	 ; 	
J3J3 	
1953 	 	 	
1354 — 	
lass 	 • 	
IWfl 	 	
1657 	
1S53 	
1150 	 _
1WO 	
1961 	
I9S2 _ : . '
1W3 	 _
1964 	
19M 	
1063. 	
1967 	
1563 	
1J69 	
1070 	
im 	
1972. ... .. '.
n73(toJoJy l) 	
1973 estimated (to Dec. 3D .
1973 	 	 	 ^
1974 (la Juty 1). 	 	

Aldrta
O.ooo Ito)
1,45*
J.2SS
814
1.234
2.W3
4,372
8.4»
2.431
4.971
S.SM
8.100
9.9M
10.SS4
12.152
12.603
14.778
19,377
13.092
1X400
9,902
8. COO
11.615
11. US
8,721
00.000)
9.900
9,700

Dlrldrin
(1 ,000 Its)
0
IM
710
1.134
1.777
2.SSS
3.6M
2.S73
3.074
' 3.008
2.SM
2.764
' 2.310
2.6S5
2.0S2
1.314
1,503
1.473
1.132
1.208
749
704
110
433
(57iJ)

_

                         1944  1944 IW3  1971
Cotton (follsse}	  757 '  20   1_
Public heoith		92	"...
Government programs..	  133  205""l04
Fruit (fotlase) (plum corcalfo)..  202  4CS  317 "126
Mothproofuip	•	;	 820  153
Sranll prafiu (foliage)	  175' ISO	I
Email Package (borne and gar-          	    "
  don oa>)	:	 277   M     2
  9. The domestic sales of aldrln and dleldrln
from  1950 through  July 1,  1974.  Including
consumer/specialty sales but excluding ealea
to the World Health Organization and tiie
Agency for International  Development are
as follows:
   10. The_Aldrln/Dleldrln Advisory Commit-
 tee appointed by the Administrator Issued  a
 report  March 23, 1972,  which'contained'the
 following conclusions and recommendations:-
   Conclusions. We  find  evidence  of human
 Injury  from present or  past use of aldrln or
 dleldrln.  Nevertheless the'facts  that fairly.
 low levels  of dleldrln can  cause cancer In
 mica  and  Interfere  with . reproduction In
 some blrds'are matters for concern, and point
 to the need for more careful evaluation of the
 hazard to man There Is clear evidence that
 past  usages have been  deleterious  to wild-
 life. Several such.past usages have been  vol-
 untarily abandoned by Shell Co. Nevertheless.
 we feel that we must strive  to find alternate
 methods of pest control. Including nonchem-
 Icnl methods, for all  compounds  which lead
 to persistent residues In humans or wildlife,
 even when such residues are not demxrastrn-
 bly harmful.  How can we move towards  this
 objective.  When aldrln or  dleldrln  can be
 safely and economically replaced by nonper-
 slstent  pesticides they should be so replaced.
 Several practices  which  can readily lead to
 damaging effects upon non-target organisms
 should  be abandoned  now In spite of the  dif-
 ficulty  of  economic replacement,  Including
 all applications which lead to contamination
 of aqueous environments such as rice fields
 and waterways.
 •  The direct application of aldrln or dleldrln
 to soils leads to negligible teaching or other
 transfer from, these  solla, and environmental
 contamination  Is  thus  very  small  except
 where  substantial erosion takes place. One
 of the  few  studies  to estimate the  amount
 •which volatilized Indicates  that  3  percent
 escapes this way. and  thus contaminates  the
 environment directly  (we would like to  see
 more extensive data upon this point).
   Rfcommerula.tiorra.  The following recom-
 mendations  are  designed to build  a basts
 of facts on which permanent recommencrtt-
 tlons can be formulated, and  to  eliminate
now those uses of aldrln or  dleliSrtn which
result In slgnlflcAnt envtrorowntaj contam-
 ination  (especially to water*-./i). We believe
 that applications  directly, to \MU  or to ma-
 terials burted In  sou (e.g.  ttrmlto control
In foundations, and seed b«\.fcnents  when
 properly applied)  lead to little subsequent
movement  of these  Insectlclc^fia, and should
be permitted.
                                   FEDExAl RECISm, VOC  39,  NO. 203	RUDAY.  OCTOBEJ 18, 1774

-------
                                                                47
                                                              NOTICES
   In the following recommendations, we use
 the term "experts" and "acknowledged au-
 thorities"  advisedly.  The EPA  must  seek
 contractual or other arrangements with In-
 dividuals and Institutions accepted  as au-
 thorities by  their peers  In the  country at
 large.
   1.  A  committee  of  experts In  chemical
 cardnogenesIs should be  formed to propose
 specific  experiments and to agree upon  suit-
 able  protocols to provide a arm  Indication
 of the extent of carcinogenic  hazard. These
 experiments  should  Include  studies  (In at
 least two vertebrate species) on the effects on
 the progeny  of mothers  fed dleldrln  during
 pregnancy  and  nursing,  the  progeny   also
 being fed dleldrln thereafter.
   2.  The economic  consequences  of  total
 withdrawal of aldrln and dleldrln should be
 explored In depth:  On  all major  crops, ac-
 tual experimental studies must be performed
 to.obtain new, reliable data provided by ac-
 knowledged authorities, and should Include
 studies  with and without alternative  non-
 persistent pesticides, over a series, of years,
 and In appropriately distributed geographical
 areas.
   3. The fraction of aldrln and dleldrln which
 escapee  by volatilization  following applica-
 tion to a variety of soils, under conditions of
 application and  treatment levels commonly
 used In  pest control, should be measured by
 acknowledged authorities.
   4. Monitoring  stations  should  be  estab-
 lished In the U.S. and abroad, at  which air
 and water  samples can bo taken at  fixed
 places over a series of years, and analyzed by
 unambiguous procedures for oldrtn and  dlel-
 drln. The  Intent Is  to study  whether  the
 restrictions we propose  do Indeed lead  to a
 progressive removal of these compounds from
 the environment. Agreement should also be
 •ought amongst  a group of experts for un-
  mblguous  procedures  for determination of
 Jdrtn and dleldrln In extracts of air.  soil.
 water, food and human and nonhuman  tis-
 sues. Such procedures should be standardized
 In the U.S. and preferably Internationally as
 well.
   5. The  following uses of aldrln or dleldrln
 should be disallowed.
   (a) All applications by aircraft. .
   (b)  All foliar spraying or dusting.
   (c) Moth proofing by the hot acid dye bath
 method or related methods In which residues
 are  discharged  Into  waterways or settling
 ponds.
   (d)  All uses, whether  by homeowners or
 pest-control operators. In homes, barns, poul-
 try operations or other structures occupied
 by humans or livestock.
   (e)  Use upon  turf  (Including  lawns  and
 non-grazing grassed areas) except as super-
 vised or  controlled  by  trained or licensed
 pest-control  operators,  greeaskeepers  and
 nurserymen.
   (f) Any use which Involves application to
 streams,  ponds, lakes, flooded  areas or  any
 other aquatic environments.
   6. Specific uses of aldrln and dleldrln which
 we believe  to be valuable and  not harmful
 Include:
   (a) Direct applications to soils.
   (b)  Seed treatments,  when the  treated
 seed la labelled "not for food use".
   (c) Dipping of plant roots or tops during
 transplantation.
   (d)  Treatment of  foundations, by current
 procedures, for termite control.
   (e) Use of treated hot-caps.
   7. Because our recommendations are based
 upon  evidence  which,  although  the  best
available. Is still not complete; we recommend
 that the environmental.and economic effects
 of the proposed  restrictions be reviewed 5
 years after  their Imposition.  By that time.
 he completed results  of recommendations
 , 2, 3 and 4 should be available.
   11. Cancer Is a major and Increasing cause
 of death and morbidity la man. It  Imposes
 upon society  on Immense  burden of death,
 suffering, and economic loss.
   12. Chemical carclnogensls  has  two  key
 characteristics, Lrreverslblltty  of effect, and
 long latent period between Initial  exposure
 and manifestation of symptoms. In principle.
 no dose  or a chemical carcinogen Is too small
 to Induce  cancer In  susceptible  Individuals.
 Some  cancers  do  not develop until late In
 life—in  man. usually 20 and sometimes 30 or
 40 years after Initial exposure.
   13. Chemicals known to cause cancer  In
 man have been  Identified  only  through
 epldemlologlcal studies, either  In the general
 public, or la occupatlonally exposed workers.
 In the case of  aldrln/dleldrtn, epldemlologl-
 cal studies in the general population are not
 possible  because there are no clearcut dif-
 ferentials of exposure and because the period
 of exposure has been too short. A study of
 occupattonally exposed workers,  carried out
 by the Shell  group  of companies,  is of no
 value, from an epldemlologlcal  standpoint, as
 a carclnogenlclty study because  the number
 of workers studied was too small, the period
 of observation  was too short and only active
 male workers  were  studied.  As  with most
 chemicals. It Is therefore necessary to rely
 on experiments with animals  to determine
 the- potential carcinogenic hazard of aldrln/
 dleldrln  to man.
   14. The use of experiments with animals to
 screen chemicals for potential carcinogenic
 hazard to  man Is  accepted by the scientific
 community and by public  policy-making
 agencies In the United States. Chemical cor-
 clnogenesls In animals  provides a very close
 parallel  to chemical  carclnogenesls In. man.
 All chemicals known to cause cancer In man
 except arsenic which  Is under  study  also
 cause cancer in animals,  especially rats and
 mice.  The  pathological   development   of
 chemically Induced  tumors In animals and
 In  man  Is very similar.  However,  human
 populations  are  more  variable  than  the
 strains of animals usually used In laboratory
 teats, and  some Individuals are  likely to be
 correspondingly more susceptible.
   15. Chemical carclnogenesls  Is a specific
 biological process which Is  Induced by only
 a  relatively few classes of chemicals. It  Is
 not true that  all chemicals induce cancer
 at sufficiently high doses. Most, probably all,
 chemical carcinogens that have  been ade-
 quately tested cause  cancer in more than one
 species of  animal. It Is not true  that there
 are "species-specific" carcinogens. Also. It Is
 not true that there are "strain-specific" car-
 cinogens, but some strains of mice are espe-
 cially  susceptible  to  Induction  of  certain
 kinds of  tumor.
   16. Transplantabillty of  tumors  and/or
 metastaslzing  to other organs  provide proof
 that chemically Induced tumors  are "malig-
 nant";  however, all  chemical  tumorigens
 should be regarded as potential carcinogens.
   17. Guidelines for  conducting acceptable
 experiments on chemical  carclnogenests In
 animals  have  been  recommended by expert
professional committees. The mouse and the
rat are  the preferred experimental  animal
species, both because their relatively short
 llfespan  permits  lifetime  testing within  a
 reasonable  period of  time,  and because the
pathological development of tumors  In these
species Is particularly well known  and under-
stood.
   18. A number of adequately conducted ex-
periments  have  shown  conclusively  that
 aldrln  and/or  dleldrln Induced cancer In 5
 different  strains of mice, and. perhaps, In the
rat.
   19. Reported  carclnogenlcity  test3  with
 aldrin  and  dleldrln   In dogs and  monkeys
were carried out for too  short a period  to
draw any definite conclusions,  but pre-con-
  cerous lesions were observed In the Uvers of
  the dogs. No  adequately  conducted carclno-
  genlclty test  with aldrln or dleldrln  In any
  species of animal has given negative results.
    20. In the  experiments with mice, aldrin
  and dleldrln induced cancer primarily In the
  liver, but  In some  experiments  significant
  incidence of  cancers of the lung and other
  organs was reported.
    21. Tumors produced by aldrln and diel-
  drln in mice  have been diagnosed by expert
  pathologlsts  as  unequivocally malignant.  In
  some experiments tumors metastaslzed  to
  other  organs, or were successfully  trans-
  planted  to other hosts,  providing  further
  proof of malignancy.  In at least some experi-
  ments, malignant tumors produced by aldrln
  and dleldrln significantly shortened the life-
  span of  the  experimental animals. In the
  moot extensive series of experiments, carried
  out by Shell research scientists, the Inci-
  dence of liver and other tumors In mice was
  clearly dose-related.  A significant Increase
  In  the Incidence of  liver and  other tumors
  was observed  at the  lowest dose  tested, 0.1
  ppm In the diet.
   22. Even  a limited  exposure  to  aldrln/
  dleldrln  for only a  few weeks early In life
  led to a  significant increase In  liver tumors
  In mice, despite cessation of exposure.
   23. None of the reported experiments  In-
  volved exposure of the experimental animals
  to aldrln/dleldrin prior to weaning, although
  younger  animals  and  fetuses  in utero are
  likely to be more susceptible to these agents.
   24. Dleldrln Induces  enzymes In the liver
  which  may activate  certain environmental
  carcinogens.   A  threshold level   of  dietary
  dleldrln  for Induction  of  these enzymes  In
  man Is not known.
   25. There Is  no scientific basis for the exist-
  ence of a "threshold" or "no-effect" level  of
  exposure of an animal population  to a chem-
  ical carcinogen. It Is  impossible to establish
  a "safe"  level of exposure of aldrln/dleldrin
  to man.
   28. Aldrin/Dieldrln have been found to  be
  carcinogens In the mouse as a result of ade-
 quately conducted testa  In laboratory con-
 ditions. They  pose a  carcinogenic hazard  to
 man.
   27. Many kinds of  Insects spend "at least
 part of their lives In  the  soil. Of the thou-
 sands of  Insects  in or on our soils, only  20
 or so are classed as  pests of  corn.  Except
 for a few species, they are general throughout
 the corn-growing areas of the United States.
 While most of the impotrant soil Insect pests
 are found over broad  areas, usually only one
 or a few at a time  are of significant eco-
 nomic  Importance In  an Individual  field.
 The area, population dynamics, weather, soil
 type,  crop  rotation  and  general  agronomic
 practices will  Influence the buildup of In-
 dividual destructive species.
   28. A common characteristic of  all soil In.
 sects Is their  four-stage life cycle: (I) Egg,
  (2) larvae (worm or group), (3) pupae (rest-
 Ing stage)  and  (4)  adult (beetle, moth  or
 fly). Eggs are laid by  the adult  female  In
 areas suitable  to that species. Northern corn
 rootworm female beetles will lay  their eggs
 In cornfields.  Female  "click" beetles (adult
 wlreworms)  usually  seek  out  grassy areas
 so the young  larvae will hove sufficient food.
 However, In Iowa an annual species has been
. reported to lay eggs in only the  bare spots In
 Qelds. Where  eggs are laid plays  an  Im-
 portant role in what Insects will be present In
 the spring  corn crop as farmers  csn plant
 corn following many  crops or  sods.  Eggs
 hatch Into larvae which are commonly called
 grubs, worms  or maggots. With  the  group
 called soil Insects, this Is the stage rhat usu-
 ally causes the most damage except for most
 notably  the seed-corn  beetle.  Most  of the
 larvae,  with the  exception of the Northern
                                  FEDERAL REGISTER,  VOL 39,  NO. 203	FRIDAY,  OCTOBE* 18,  1974

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                                                               48
                                                             NOTICES
  and Western corn rootworms, have food pref-
  r    *es other than. com.  Most are general
      n and when their main food supply Is
  removed they readily adapt to corn. As larvae
  mature they enter the pupal stage of growth.
  Ic'3 hero they complete the change from lar-
  rae to adult beetles, or moths or flies. A few
  fit the adult soil Insects are also destructive.
   119. .The corn, soil Insects which presently
  can.  or do cause  Injury of economic signifi-
  cance are as follows:
   (a) Wtreuorna: Uelanotua ap.. Conoderua
  jp. and Hori3tone>tU3 yp. and other species
  of Wi« family Elaterldae. Wlreworms species
  attacking corn may differ some In  specific
  areas but In i.-neral they all cause similar
  damage to seed arid young  plants. Afelanotua
  ap. are most common throughout corn areas
  and pose the most problems for com growers.
  Most of th« damaging wlreworm species have
  a life cycle from egg to adult of 2-4 years. The
  life span appears to be longer (4-fl years) In
  colder  climates and shorter  (2-3  years) In
  southern areas. The Conaderta ap. is an an-
  nual wlreworm laying eggs In grain stubble
  which  has not been second cropped. These
  wlrewonns are most prevalent in the south-
  eastern United States but are becoming more
 of a problem In the central Corn Belt. Adult
 wiraworms (click beetles)1 show a preference
 for sod anas and eggs may be laid In pas-
 tures, grain stubble, hay fields, weedy  row
 crops acd other grassy areas. When sod or
 other grassy areas, are tilled for corn the
 next spring, the worms feed on the corn seed
 and young corn plants aa  their other food
 diminishes  with  the elimination  of  weeds
 and grass. Because eggs are laid each year In
 grassy fields, wlreworms  with more than a
 one-year cycle may b» present In any stage.
 When populations ore heavy they may com-
 pletely  destroy not  only the original plant-
 Ing but subsequent replantlngs.  Wlrewonns
 like and  need moist soil "id wm tend to
     •* the moisture table In the ground. In
     t spring they will be more of a problem
 than In a dry pne. Wlrewonns will  tunnel
 Into newly planted seed and  kill the ger-
 mination. They will also bore Into the base
 of young com plants below ground  killing
 the growing  point In the  corn  plant. The
 r.ewly-emerged plant starts to wilt and die
 from  the -center  out and finally the entire
 plant dies or produces suckers which bear
 no ears. In large numbers,  entire fields can
 be  lost.  Planter  box treatments  and row
 treatments of alfirln are not aa effective  aa
 broadcast applications and  may not provide
 adequate control under population stress.
  (b)  Cutworms. Black* cutworm, Agrotia
 ypiilon  (Rottenburg); Glassy cutworm. Cyr-
 modea devastator (Brace); Bronzed cutworm.
 Nephilodei emmedontiu  (Crawer);  Dingy
 cutworm,   Feltid   subgottiica  (Haworth);
 Brlstley cutworm. Lactnyolia renlgera (Ste-
 phens) ; Clay-backed cutworm Agrotia gladl-
 aria  (Morrison):  Sandhill  cutworm. £uroa
 deteroa  (Walker). The black cutworm Is by
 far the most widely found and the most
damaging. Most of the problem species  are
surface feeders except for the glassy cutworm
 which Is a true subterranean cutworm. Cut-
worms will  generally feed  on  the newly-
sprouted plants. Moisture In the soil and at-
mosphere conditions help to  control the feed-
Ing pattern. When the soil Is moist or wet and
 nights are cool with high humidity, the cut-
worms win feed on  the surface cutting off
the corn plants. As  the soil dries  the cut-
worms may not surface, feeding only below
ground,  living In the moist soil. Much of the
life cycle and biological history of the cut-
worms Is still unknown. However,  In general,
 they tend to overwinter as nearly  full-grown
larvae. Adult moths tend to lay eggs In grassy,
wet areas. Black cutworms not only over-
•"•'-ter as  larvae but migrate Into the Corn
  Belt area from the south In March and April.
  Cutworm damage Is generally associated with
  poorly drained river bottom land, heavy soils
  and low wet spots In upland  field*. It Is also
  more extensively found In first year corn fol-
  lowing  aod  or legumes. Failure to notice a
  cutworm problem early may  result In  a lost
  field or part of a field that must be replanted.
    (c) WMte gruoa: ^fiyUophcga or Haehnoa-
  tenna app. These are the most common grub
  pests.'They  are  the larval form of the com-
  mon May and June beetles. The beetles prefer
  grassy areas such as  pastures, soil bank land
  and hay fields. These differ from  •"""•*'
  grubs by having life cycles that take 2-4 years
  to complete. Three-year cycles are most com-
  mon. White  grubs appear most often In cam-
  fields whea. sod ground or grassy areas are
  spring plowed. With their 2-4 year life  cycle.
  they con pose a  problem to the farmer more
  than one year. However, the most destructive
  damage occurs the first year after sod. Dam-
  age comes In the form of plants wilting and
  "drying up." The larvae prune the roots and
  the plant literally dies of thirst.
   (d) Corn Rootworma. Northern Corn Root-
  worm. Diabrottcd longicomia  (Say); Western
  Com Rootworm.  Diabrotica  virgifera (La
  Conte); Southern Corn Rootworm, ZHabrotica
  undecimpunctate  howordi   (Barber). The
  Northern corn rootworm  Inhabits the en-
  tire  Corn Belt  while  the Western can be
   found In  damaging  numbers In Colorado.
   Nebraska, Kansas, South Dakota, Minnesota!
   Iowa. Missouri, Illinois, Indiana, and Wiscon-
   sin. The first Western beetles were found In
   Tnrtlftrm  In 1071. Southern corn rootworma
   migrate  north  each  year and ore usually
   more of  a problem In the southern area of
   the Corn Belt or In southern corn-producing
   areas. Northern and Western corn rootworm
   adults lay  their eggs In  cornfields during
   August and September. The eggs overwinter
   and hatch the following spring In late May
   and June. If com is present they feed and
   survive. The life cycle Is broken by rotation
   as  Northern and  Western rootworma need
   com to  survive. Southern corn  rootworms.
   on the other hand, overwinter In southern
   areas and fly north each year, laying eggs In
   the spring In planted cornfields.  In some of
   the southern corn-producing areas, two gen-
   erations  a year may  occur. After hatching,
   the larval form of the loutworm begins feed-
   Ing and tunneling into roots. In severe cases
   corn may wilt and die from root pruning.
   Usually, however, the root pruning results in
   weakened stalks that are subject to lodging
   and yield reduction.  Western, and. Northern
   com rootworms are  generally .resistant  to
   chlorinated hydrocarbons.
    30. The Influence of previous crops on the
  prevalence of sell insects In corn Is as follows:
        Underground corn tas*c<3
                                   Other major factor
                                                           Tear following meadow
                                                    1st
                                                           2d
                                                                   3d
                                                                          4U)
                                                                                  4th
Elreworms 	 .,........— -......,.«


Sod webworms (5 species) 	 	
• White gnibg (2-3 species) 	 	 „



Southern corn rootworm 	 	
Northern and western corn rootworm.. 	

Boll TPOlstnn........







.


XX
XX
XX
X
*v
XX
x
x
X x


x

x

x
x

u
x
— XX






x


x
XXX






..



XXX












   31. Registered and effective alternatives to
 Aldrtn for control of rootworms In corn are
 Furadan. Thlmat, Dasanlt. Dyfonate, Dlozl-
 non and Mocap. Counter has a temporary
 use permit and Is expected to b» registered
 for rootworms and wtreworms before  the
 1978 crop year. Dow Chemical Company Is
 presently seeking registration of Dursban.
 Insecticides  which control  resistant  root-
 worm  will  also control nonreslstant  root-
 worm.
   32. Dlazlnon is registered as a  preplant
 control  method  for  the  cutworm and an
 application Is pending for  Furadan.  Reg-
 istered  and  effective  insecticides  for  post
 emergent treatment are Carbary] and Dylox
 baits or sprays and toxaphene sprays.
   33. Registered and  effective alternates to
 Aldrtn for control of wlreworms In corn are
 Dasanlt, Dlazlnon, Dyfonate and  Furadan.
 An application Is pending for registration of
 Mocap.  Thlmet Is labeled for reduction of
 wlreworms.
   34. No   significant   macroeconomtc  or
 mlcroeconomlc  consequences  will result
 from  the suspension of aldrin for use- on
 com In 1975.
  35. The Fuller Rose Beetle was recognized'
 as a pest of  Florida citrus  In 1952 when
 large  numbers  were  observed  in  several
 groves In Indian River antf St. Lucle Coun-
 ties. Since that time, this pest has been col-
 lected from 30 counties In the state. Its life
 cycle adheres to the 4-stage pattern Inherent
 In beetles consisting of the egg. larvae, pupa.-
 and adult. Eggs are deposited above ground,
 the hatchllng larvae drop to the ground and
enter the soil to  feed for  10-11 months, a;
they mature, on  roots. Pupation  occurs in
the soil and adults emerge from the soil to
  remain above ground feeding on the foliage.
  mating, and laying eggs. It Is presently con-
  sidered unlvoltlne, producing but one^gen-
  eration per year. The adults feed on the
  young leaves  of citrus and when in great
  numbers, cause  serious setback of  young
  plants. Adults also feed on- the flowers and
  on rind of young fruit, resulting In unsight-
  ly  peel scars  when  the fruit matures. Oc-
  casionally, young shoots may be devoured.
  The most serious Injury by the pest is pro- •
  duced by the larvae which destroy the plant
  roots.
   38. Affected trees have sparse  foliage that
  may become chlorotlc and wilt. When larvae
  are numerous, young plants may be killed In
  a  short  time- or dwarfed.  Older trees  ore
  more resistant, but do not  grow well, are
  unthrifty  In  appearance,   become   poor
  yielders,  and   occasionally  die.  Since the
  damage caused by the  larvae  takes  place
  underground.  It  often remains unnoticed
  until the plants start to  wither and 'die
  back'.
   37. Although the Fuller Rose' Beetle has
  been  collected from  30 counties  In Florida,
  Its  economic  significance  is  very  circum-
  scribed geographically. Of the 877,000 acres
  of citrus In Florida, the rose beetle !s only
 present In numbers  sufficient to commence
 to reduce yield on between 1.3,000 and  50,000
 acres. The area of significant Infestation  is
 essentially  the Indian River area- of the
 Southeastern seaboard of Florida,  an area
 characterized by poor>lnferaal soil drainage,
'a high water  table,  and consequently un-
 usually shallow citrus  root systems. A 1955
 s.udy  indicated that  In a typical In'Jkm
 River grove,  75 percent of the feeder roots
 of citrus trees were located within 18 Inches
                                 FEDERAL  RSGISTER,  VOl.  39, NO.  203—FRIDAY, OCTOBER  18,  1974

-------
                                                               49
  of tie top of th« rldga of sod upon which
  citrus trees are usually planted in tiiat area.
  CUrua tisea  Tont ertand their  roots  Into
  waterlogged soils. The result la trees  distin-
  guishable by particularly restricted roo* sys-
  tems  with  unusually limited supplied  of
  feeder roots. These systems axe less able to
  make do with decreases In root productivity
  resultant  from Insect damage which would
  be Insignificant in other regions  within  the
  state.
    38. Less than 3 percent  of the total citrus
  acreage In Florida has ever been treated with
  any soil Insecticide for control of  any  insect,
  and even within the Indian River Fuller Rore
  Beetle trouble region only 20 percent  of  the
  acreage has been so treated. The Puller Rose
  Beetle Is one of the -more minor citrus pests
  In Florida. However. In some cases, the Fuller
  Rose Beetle'is present In an  area In such
  numbers  that citrus yields are substantially
  reduced.  In  most of those  Instances,  21/,
  pound  per acre treatments  of  aldrln twice
  during a' growing season  will provide ade-
  quate pest control. Citrus yields are reported
  to have markedly increased after Insect dam-
  age and such treatment.
   39. The theory behind aldrtn/dleldrtn soil
  treatment for citrus beetle  control la that
  the chemicals should be Incorporated  In the
  surface of the soil surrounding citrus,  creat-
  ing a toxic barrier. Beetles may be killed dur-
  ing two stages of their development, when
 as larvae  they drop from  aerial  regions of
  vegetation and enter the  soil  to  feed, and
 when its adults they emerge from  the soil
 to remain above  ground,  feeding,  mating,
 and laying eggs. In a series  of threshold tests
 In 1957 and  1958. aldrln  provided approxi-
 mately 78 percent control of rose beetles.
   40.  Aldrln/Dleldrln Is overused  on  citrus
 to some extent, In the sense that It Is un-
 necessarily utilized.  Citrus growers can tol-
 erate  some crop loss before pesticide appli-
 cation Is  economically Justified, yet before
 application of these chemicals they generally
 do  not  consciously  formulate  economic
 thresholds  for determining  when  aldrln/
 dleldrin pays for Itself In terms of Insect con-
 trol. In some  Instances, and  particularly  In
 the case of nurseries, these chemicals are
 employed as preventatlves  or Insurance be-
 fore  Insect  damage  Is  discerned.  Many
 growers attempt  to eradicate  Insect  pests
 through   applications  of   aldrtn/dleldrtn
 rather  than reducing them to  Insignificant
 levels.  In  certain  Instances,  however, the
 rose beetle substantially reduces crop yields
 absent the use of aldrln/dleldrln and with-
 out alternative means of control. In terms  of
 the entire Florida  citrus  Industry  these In-
 stances are relatively rare.
  41. The  Coca-Cola Company, as  one  of
 Florida's largest citrus growers, does  not use
 aldrtn/dleldrtn. receives fruit from groves
 located In areas where root weevil Infesta-
 tions occur, yet carries on  profitable opera-
 tions. The  Company's decision not  to utilize
 these chemicals was s-ubstantlally the result
 of worker  pressure resulting from, possible
 health and safety problems  Involved In  their
 use.
  42.  In view  of the life  cycle  pattern  of
 the rose beetle, whereby these insects  gen-
 erally mature  from a  larvae stage In the soil
 Into adult  weevils and then climb  up weeds
 or citrus trunks or branches to lay their eggs.
 there Is  a  large potential for disruption  of
 the pest problems through cultural  methods.
 If weeds and low-hanging  citrus  branches
 are cut down, major routes of access to the
 egg-laying  areas of citrus will be closed off
 to the weevils. Particularly in California, cer-
tain sticky  bands have been placed around
trunka and have been effective  In  reducing
the alternate  path  of weevil ascent. If the
                  NOTICES

  adult Insects can efTectlvely be denied  such
  ascent, their dataage to the aerial regions of
  Cltrua trees can be minimized and the In-
  secta procreatlve habits and efficiency can be
  stunted.  Such  means  of  pest control  have
  not been extensively pursued In Florida.
    43. California does not recommend the use
  of aldrln/dleldrta  for  control of the Fuller
  Rose Beetle on Its  very  substantial citrus
  acreage although such Insect also constitutes
  a pest of citrus In that state. Instead, the
  California spray program recommends mala-
  thlon for concrol of the Fuller Rose  Beetle.
  and both se"ln and parathion to help  with
  that beetle and to control certain other lu-
  sect  pests  of  citrus.  Even within Florida,
  parathion and  fzuthion.  registered alterna-
  tives, are recommended as pirt of that state's
  spray  and  dust  program. Various  foliar
  sprays, most of which are already used In the
  Florida citrus program, some  as often  as 4
  to 8  times a year, provide good  Initial  kill
  of the adult weevil at Issue. Included among
  these are  malathlon, furadan. sevin, guthlon,
  orthene,  lannate. supraclde, and phosphaml-
  don.
   44. Suspension of the use of aldrin/dlel-
  drln on citrus would not result In detrimen-
  tal macroecoaomlc consequences. The need
  for treatment  of the  Fuller Rose Beetle Is
  very confined, cultural and Insecticldal al-
  ternatives are available and any adverse con-
  sequences will very easily become translated
  into a relatively minor shift In the supply-
  demand equilibrium. Nor are substantial mt-
  croeconomic consequences  anticipated.
   45. No significant macroeconomlc or micro-
 economic  consequences will result from the
 suspension of aldrln or dleldrln until com-
 pletion of the cancellation proceedings  for
 all uses  Involved In  these suspension pro-
  ceedings In addition to corn and citrus.

                CONCLUSIONS

   I.  Carcinogenic activity of a chemical can
 be detected by  observation In man and by
 bloassay  in experimental animals. The con-
 clusive detection of the carcinogenic effect of
 a chemical by direct observation  In man Is
 extremely difficult. It may take 20. 30 or more
 years  for  a population  to respond  to a  new
 chemical  exposure with a significant Increase
 of cancer  cases due to the long latent period
 Involved, that Is. the time  between exposure
 to a carcinogen and the manifestation of the
 effect, namely the  tumor. In addition,  the
 frequency of cancer In the population Is very
 high, so that In order to demonstrate the ex-
 istence of  an Increased risk related to a given
 exposure one needs a well-denned large popu-
 lation with  known  history of exposure  and
 another comparable control population with-
 out that  exposure. In the case of materials
 that  become  contaminants  of the rvhole
 population, such as dleldrln.' this approach
 is almost  Impossible or nonappllcable.
   Consequently,  in  the  case of a food con-
 taminant such as dleldrln where the Identi-
 fication of a non-exposed control popula-
 tion is difficult or Impossible, the chances of
 detecting  a carcinogenic effect  by observa-

  • Surveys conducted by the Food  and Drug
 Administration show that dleldrln Is found
 In as much as 96 percent of all meat. ash. and
 poultry "composite samples" tested, and  85
 percent of  all dairy product "composite sam-
 ples"  tested. In  addition, EPA surveys  in-
 dicate  that dleldrln Is  In  approximately  90
 percent of all air samples  taken nationally
 and residues of dleldrtn  have been found  in
 virtually ail of the humans  Included In the
EPA human monitoring survey. While the
FDA surveillance  program found less dieldxta
present than  in its  mart-.et  survey,  the
amounts found were still significant.
  ttous iu man  ire extremely  remote."  The
  human epidemlologlc study  by  the  She!1.
  group of companies involving  workers at the
  Pernis.  Holland Plant: is admitted  by the
  Shell Chemical Company not to be an  ade-
  quate epidemiologies! study for cancer and
  was clearly so described by expert epidemiol-
  ogists  In  these  proceedings.  In short,  this
  study only examined  a very small number o.'
  Individuals  for a  period of time tot.illy in-
  adequate to assess a change  in cancer rlsl:
  extending over most of a lifetime.
    For all  practical purposes, the  detection
  of carcinogenic activity of new chemicals  is
  based on animal experimentation. All chemi-
  cal  substances  or  mixtures that have been
  proven carcinogenic by direct  observation in
  man have also been shown to be carcinogenic
  In experimental  animals with the exception
  of arsenic which Is still under experimental
  study. Because of the difficulties of epldemi-
 •ologlcal  studies on human carcinogenic ex-
  posures, there  are usually no  data  which
  provide  us  with  any evidence  on whether
  cancer  in man is caused by a  chemical that
  has been shown to be carcinogenic in other
  mammalian  species.
    Bloassays are always performed on a num-
  ber of animals which is extremely small when
  compared with  the millions of  humans ex-
  posed to most environmental  carcinogens.
  Such studies can  only detect  carcinogenic
  effects resulting in fairly high Incidences and
  the number of  animals used In the tests Is
  the main limiting factor of the sensitivity of
  the test  system. The sensitivity of currently
  used  animal bloassay systems  Is  In most
  Instances very limited. Therefore, any chemi-
  cal which is detected as carcinogenic by such
  rather Insensitive test systems represents a
  warning signal of great significance.' In fact.
  while It Is customary  or required that more
  than one species  of  laboratory  animal be
  tested for carclnogenlctty, a  positive, con-
  firmed finding as to one species Is of extreme
  and grave  importance.'  This Is  reflected In
  the Delaney Clause or  Amendment  to  the
 Federal  Food, Drug,  and  Cosmetic Act  (21
 U3.C. 348(c) (3) (A) )  which provides that no
 food  additive "shall  be deemed to be safe
 If  It is found to Induce cancer when Ingested
 by man or animal" and which "Is generally
 Intended to prohibit the use of any additives
 which under any conditions Induce Cancer In
 any strain of  test animal." "Bell v Ooddard "
 366 F.2d  177,  181 (7th Clr. 1966). Conversely.
 negative findings In carclnogeniclty tests  are
 of  little significance In view of the Insensitlv-
 Ity of the system.
  II. Carcinogens are chemical, physical  or
 biological agents,  exposure to  which,  of
   •The detection of the great cancer "epi-
 demic" caused by cigarette smoking was made
 possible by  the  existence of a non-exposed
 population living  in otherwise comparable
 conditions with  those exposed. Also, besides
 the comparison of smokers and non-smokers.
 a  quantitative estimate  of the amount of
 cigarettes smoked make It  possible  to  Iden-
 tify groups of population at different  risks
  1 Jager.  Aldrln. Dieldrln. Endrin. and Telo-
 drin:  An  Epldemiological and Toxlcologlcwl
 Study of  Long-Term Occupational Exposure
 (1970).
  • It should be stated at  this point, perhaps,
 that a relatively  small number of chemicals,
 700-800 or a maximum of 1.000, have proven
 to be  carcinogenic in laboratory animals. It Is
 not true that all or most substances can cause
car.cer In laboratory animals depending upon
the dose applied.
  •This Is so. In  part, due  to the nature of
cancer,  that  is. Its  irreverslbillty and long
latency period  following the Initial exposure
to  the carcinogenic agent.
                                  FEDERAL. REGISTER,  VOL  39,  NO. 203—FRIDAY.  OCTOBER  18,  1974

-------
      nals or humans. Increases the probability
     .nductkm of tumors or neoplaslo. This may
  be manifested by an Increase in the number
  of individuals developing the tumor, an In-
  crease In.the number of tumors In.each in-
  dividual, a decrease-In'the age at which the
  tumors appear,  that Is. reduction  In the
  Intent period of  tumor Induction, any  com-
  bination of the above effects and perhaps the
  appearance of unique or unusual tumors.
    It Is patent, it seems to us,  that  on the
  basis of our current knowledge or "conven-
  tional wisdom" the'evidence Is overwhelming
  that aldrln ant.  dleldrln are carcinogens in
  the mouse." '. ..is is established by the testi-
  mony of extreinely welt qualified and renown
  experts la the field of corclnogenesls juch as
  Drs.  Samottl.  Heston,  Farber, Epstein and
  others based on many laboratory tests of the
  mouse." in fact, there are probably few pesti-
  cides  whose carclnogenlclty In mice »s  so
  thoroughly and conclusively documented.
   This was. in effect, the conclusion also of
  the International Association for Research in
  Cancer which concluded In Volume 5, Mono-
  {raph on the Evaluation of Carcinogenic Bisk
  3f Chemicals to Man, as follows:
   Dleldrln was tested by the oral route  only
  j» mlc« and rate.' The bepatocarcinogenlclty
  it  dleldrln in  the mouse has been demon'
  itrated and confirmed In several experiments.
  icct some of the liver cell tumors were found
  •-o  metastaslze. A  dose-response effect has
  jeen demonstrated in  both  sexes  with an
 • '-ncreased incidence In females at the lowest
  lose tested, 0.1 ppm in the diet. (Correspond-
  Jig to about 0.015 mg/kg bw/day). In mice
  there  is no evidence  of carclnogenlclty in
  organs other than the liver.  .
   The available date, in rate have not pro-
  vided  evidence of  carclnogenlclty at levels
     up. to  60  parts  per million in the diet.
     rrespondlng to an intake of about 2.3
   ,,/kg bw/day)..-.:
   The experiments in dogs and monkeys were
 too limited in duration and/or group sizes to
 allow any conclusion to be made.
   Further, witnesses for the Shell Chemical
 Company admitted at the hearing that the
 incidence  of  liver tumors  in  6  different
 strains of mice evidenced  statistically  sig-
 nificant Increases resulting from  the  oral
 dietary administration of dleldrln and many
 of  the tumors in question  have been dlog-
   »Shell Chemical Company does not and,
 in reality, cannot dispute such conclusion.
 The position of  Shell herein is. Instead, to
 the effect, in part, that the mouse is not an
 appropriate nnim«] in this connection, a con-
 tention we shall  consider later In these Con-
 clusions. The position of the Shell Chemical
 Company has been shifting on  the  issue of
 the mouse liver  tumor  and Its significance
 and is also not in complete agreement with
 Its witnesses. This makes it extremely difficult
 to prepare a decision in the very short period
 of time available, the preparation of which
 had to begin, therefore, prior to the  filing of
 briefs or even the. closing of the record, and
 may be prejudicial to the other parties. Con-
 sequently, this decision Is responsive to what
 we had believed Shell's position to he and
 also to what it now Is. We note,  for example.
 .that  in Its brief, Shell carefully avoids the
 word "cause" in connection with dleldrln and
 tumor incidence  contrary to what wis stated
 on the record of the hearing as to Its position.
   u Wlille  aldrln  use  accounts for nearly 95
 percent of the total use of the 2 compounds.
. aldrln breaks down rapidly into its metab-
 olite  dleldrln. Consequently, residues found
 in man and  the environment are principally
   :drtn residues and thus the hazards  of
   idrln are of prime significance.
                  50

                 NOTICES

  nosed as  unequivocally  malignant.11  ma
  mice were of In-bred strains and  an out-
  bred and hybrid strain. The primary organ
  Involved Is the liver, but there was In addi-
  tion a significant Increase in tumors In the
  lung and other organs In some experiments.
  Further, positive  dose-relationship In  the-
  incidence at liver tumors primarily and In
  lung and other  tumors was manifest. Liver
  tumors metastoslzed to other organs within
  the  M»i>n*i« and  were successfully trans-
  planted and. In at least some experiments,
  dleldrln  shortened the  latent  period  for
  tumor Induction as well as Increasing the In-
  cidence of tumors. Other evidence  of dlel-
  drln's carclnogenlclty in the mouse Is also
  present.1*
   The fact  that dleldrln increased tumor
  incidence in mice of naturally occurring
  tumors does not alter our conclusions with
  respect to the findings In the mouse or their
 significance for man, to be discussed later In
 them  Conclusions. A3 explained  by  Or.
  Walter EL Heston. Chief of the Laboratory of
 Biology of the National Cancer Institute, a
 geneticist with 36 years In cancer research In
 experimental nnlmals as a basis for the prob-
 lem of cancer in man and the "father" of
 strains of test animals.
   A carcinogen, therefore, should not be  de-
 nned  only  as  something,  that produces
 tumors In a strain In which  such tumors
 never occur without the carcinogen. Such a
 strain probably does not exist. A carcinogen
 Is a substance that can Increase the prob-
 ability that a tumor will arise. It increases
 the incidence of a tumor In a strain and usu«
 e ay reduces that latent period of the tumor.
 IT. testing a substance for carclnogenlclty, the
 aim. therefore. Is to ascertain whether it ""»
 significantly  Increase the Incidence of any
 tumor, and the choice of strain for  demon-
 strating this Is usually not the'most sus-
 ceptible, nor the most resistant but one with
 an Intermediate genetic susceptibility.
 In addition. Dr. Heston further testified that
 not all strains of mice or of any other species
 have the  same  Incidence of  spontaneous
 tumors and that "One cannot therefore state
 categorically that the mouse-—La. all strains
 of the mouse—present an unacceptably high
 Incidence of spontaneous tumors." As empha-
 sized by Dr.  Heston. well controlled experi-
 ments have been run with at least 5 strains
 of mice having different Incidences of spon-
 taneous liver tumors and it has been demon-
 strated from all strains that aldrln and dlel-
 drln are carcinogenic In mice. Dr. Heston goes
 on to say that "Snowing this, and Knowing
 the general biological similarity of mice and '
 other mammalian species. Including man,  we
 can reasonably expect  that In a population
 of human being exposed to Aldrln/Dleldrln,
 cancer of some kind will occur In some Indi-
 viduals, and that these Individuals would not
 have  been afflicted in  the absence of these
 compounds."
  a There Is no valid distinction between the
induction of benign  or  malignant tumors
in determining the carclnogenicity of a com-
pound and Shell Chemical Company and Its
pathologist witness employed at Tunstall do
not contend that there is although some of
the cancer experts  testlf- Ing on behalf of
Shell appear to make such distinction.
  °The evidence In these Consolidated sus-
pension proceedings  went beyond the evi-
dence available to and the conclusions of the
1AHC quoted above. In addition, our conclu-
sions are not affected by the last minute re-
vised  data differing from  prior  published
studies adduced by the Shell Chemical Com-
pany. Also, time Is  lacking for an  acalysL:
of each of  the mouse experiments Involved
and  no  useful purpose  would  be served
thereby.
    The testimony and exhibits of the addi-
  tional experts In carclnogenesu presented by
  respondent and the Environmental-Defense-
  Fund, Inc. convincingly support the view that
  the-mouse is. indeed, an  appropriate  test
  animal for predictability to man. In short.
  most chemical carcinogens that have been
  adequately tested in different species show
  that they can produce tumors in all, or sev-
  eral of them. 'While the target organ may
  very from species to species the concept of
  species specific carcinogens la not well sup-
  ported. The  mouse  Is probably  the most
  widely utilized test animal. Is the standard
  reference test animal In recently established
  and large scale programs of the  United '
  States Department of Health, Education and
  Welfare at the National Center for Toxlcologt-
  cal Research for quantltatlon of toxlcologjcal
  and carcinogenic risk, and was extensively
  utilized, perhaps reluctantly, by the labora-
  tory of the Shell organization at Tunstall.
  England."  .            -
    The following analysis by Dr. TJmberto Saf-
  flottl. Associate Director for Careinogen'esls.
  Division of Cancer  Cause and Prevention,
  National  Cancer  Institute, a.  world  renown
  expert whose  Initial testimony-was cleared
  and approved by   this  organization  and
  whose  demeanor  and knowledge during  his
  several days of cross-examination  especially
  Impressed us.  Is helpful In this regard: »
    The argument that certain mouse liver car-
  cinogens are "species specific" was recenliy
  reviewed In a paper by Tomatls et al.= on-
  titled "The predictive value of mouse liver
  tumour induction  In  carclnogenlclty. test-
  ing—A  literature  survey."   The  authors
  searched  the  literature to make  a list of-
  chemicals that were reported to have Induced
  liver tumors in mice: 68 chemicals were In-
  cluded in this list. The literature  was then
  examined  for reports on tests of these chem-
  icals in two other  species,  rats ""j hom-
 stars. Of these 68 mouse  liver carcinogens,
 only 18 were reported to  Induce only liver
 tumors  in  mice,  while  the  others  pro-
 duced also tumors In other organs.  Of the
  18 that were reported to produce only mouse
 liver tumors,  none  was  reported to> have
 been adequately  tested la  the other two
 species  with   negative   results.  Of the
 68 chemicals which  were reported to induce
 tumors of the liver, or of the liver plus other
 organs, in the mouse, only 16 were listed
 as having  been tested and  found negative in
 one  of  the other  species  (rats or  ham-
 sters); however, of these 16, 0 were reported
 as negative in rats  but were not tested  in
> hamsters,  one  was reported as negative  in
 rats but was positive to  hamsters. 5  were
 reported as negative in hamsters but were
 positive  in rats. Thus only one compound.
 positive in mice, was reported as having been
 tested  In  both rate  and hamsters;  with
 negative   results:   this    compound   is
 benzo{a]anthrocene which not only  causes
 hepatoraas by  feeding in mice,  but'also
 causes lung tumors, and was  found  to be
 carcinogenic also  by other  routes of ad-
 ministration in mice, causing tumors of the
 lung, skin and bladder. Although this com-
 pound was reported as negative in  rats and
 hamsters.  It is Important to state that  It
  "Also significant is the l..ct that an ex-
 perimental  study involving approximately
 25.000 mice, was  established using a car-
 cinogen which Is known to produce liver cell
 tumors in mice  as well as a variety of other
 tumor types in mice and in other species.
 • "In fact, much of the preceding section
 O; these Conclusions was based on the testi-
 mony  of Dr.  Snfflotti, confirmed  and cor-
 roborated by the testimony of many other
 cancer expert witnesses.
                                  FEDERAL 8£CISTE». VOL 39, NO. 203—KHDAY, OCTOBER  18, 1974

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                                                             51
                                                            NOTICES
  •as not adequately tested In rate and ham-
  »n at all. There are no reports of such
 testa by  chronic  feeding  In  rats or  ham-
 sters, nor  of any  long-term tests with con-
 tinuous administration In large numbers of
 animals, with adequate pathology. The only
 feeding study In  rats on tola  compound
 was published In 194S *". It states that 2 out
 of  3  male  rats  were found  to  have  3
 hepatomas each. No hepatomas were found
 In  3 females,  nor In  different  groups of-
 controls.  Although Inadequate, this  report
 suggests the possibility of liver carclnogenlc-
 Ity In rata.  So the conclusion Is  that  no
 chemical   waa  found  to  have  been ade-
 quately tested and shown to produce liver
 tumors In mice  but  no tumors  In the
 other  two most  common  species  of  test
 animals. As  a matter of Interest.  Tomatla
 et al have limited their discussion to the
 correlation of test results as presented In
 the literature, without any critical evaluation
 of the adequacy of the tests used  to enter
 a classification of positive or negative Into
 their tables.  Such an analysis would show
 that many tests  la  rate or hamsters, re-
 ported as  negative, are really quite  inade-
 quate and should be rejected  as "negative
 evidence."
  The survey by Tomatls  et al. Is, however.
 sufficient  to  disprove the  proposition that
 the Induction of liver tumors In mice Is a
 tissue response that Is not representative of
 carcinogenic  effects such  as are  seen  In
 other organs or  other species. A few people
 have proposed that the carcinogenic response
 of mice is not representative of that  of other
 species  Including  man  No scientific  basis
 could be found  to support this argument."
  The Report of the  1973 Joint Meeting of
 the FAO Working Party  of Experts on  Pesti-
 cide Residues and the  WHO  Expert  Com-
 mittee on  Pesticide Residues,  which  Is not
 the official  view of  WHO but only that  of the
 participants of the expert committee, stated.
 In part, as  follows:
  • • « The Meeting agreed that there Is a
 serious  lock of  knowledge  regarding  the
 processes  involved  In  the development  of
 liver tumors  by  mice  and that It would  be
 unwise to classify  a substance as a carcino-
 gen solely on the basis of evidence of an In-
 creased  Incidence of tumors of a kind that
 may occur spontaneously  with such a high
 frequency.
  In general It was felt that If the exposure
 of mice to a pesticide was associated  with an
 Increased  risk of the development  of liver
 tumors, long-term feeding studies on at least
 one other  species  should be required. Car-
 clnogenlcity tests In two species other than
 the mouse  would be regarded as appropriate
 where It was evident that man might be ex-
 posed through food to a dose level close  to
 one that  Increased the incidence of  liver
 tumor In mice.
  utt should be pointed out at this point
that the Tomatls article further stated that
"The present review Indicates that the In-
duction of liver tumors in the mouse should
be considered as valid as the evidence ob-
tained  In the rat and/or the hamster at any
site. It does not Imply that the  chemical
which has been tested with negative results
In one or   more  species should  be  auto-
matically regarded  as having a possible car-
cinogenic effect  on  man   solely   on the
grounds that rt Induces liver tumors tn the
mouse. Conversely neither does it imply that
negative results In  the mouse muse be  re-
garded   as   proof  of  safety."  Aldrin  and
dleldrln have not on the basis of adequately
conducted   and  reported  experiments  at
proper  dose  levels been tested with negative
results  In the rat and do not appear to have
been tested In the hamster at all.
   The  meeting agreed that, although  the
 above 'considerations  might  be useful  for
 general guidance. It would be essential  for
 each pesticide to be considered and assessed
 Individually.
   This does not detract from the testimony of
 Drs. Beston, Safflottl and others with respect
 to the significance of mouse liver tumors. The
 FAO/WHO report recognizes that the matters
 there  stated  "might  be useful for  general
 guidance" but that each pesticide should be
 considered and assessed individually.  It  ap-
 pears to us  that the quoted material set out
 above from  the PAO/WHO  report Is basically
 the view  of Dr. Roe.who testified on  behalf
 of Shell Chemical Company herein and who
 was one of the Tew or, perhaps, 3 cancer  ex-
 perts on the expert committee. He admitted
 st the hearing. In effect, that the members of
 the expert committee ran determine the re-
 port  that Is Issued. For the  reasons  stated
 herein for.  In  effect, giving little weight to
 Dr. Roe'a testimony In this  connection, we
 similarly  so regard the PAO/WHO report."
 Wo Just do  not believe, on the basis of this
 record, that It represents  the current state
 of our knowledge or the accepted scientific
 view. We  are.  Instead,  Impressed by positive
 findings in  5  different strains of mice with
 differing incidences of spontaneous tumors.
 As we stated above, inbred, outbred and hy-
 brid mice were Involved In the experiments.
 (See also  discussion which follows on other
 tumors of the  mouse, and the rat). Moreover.
 Shell's own  experiments clearly demonstrate
 how natural variability can be surmounted
 and an unequivocal result be obtained. For
 example,  from a consideration  of the  fre-
 quencies of  malignant  hepatic neoplasms, as
 diagnosed by  Shell's pathologlsts, it  Is ap-
 parent their spontaneous Incidence In control
 animals la neither high nor  variable, while
 the dleldrln treated groups  consistently show
 marked and often high Incidence  of such
 malignancies.

   Shell Chemical Company further con-
 tends that a large  variety of factors,
 chemical and nonchemlcaJ, can  greatly
 alter the Incidence of tumors In the liver
 In the mouse and.   thereby,  challenges
 the appropriateness  of the mouse as a
 test animal and Its applicability to man.
 Specifically, Shell has reference to the
 fact that sex, hormones, diet «-M  other
 factors can influence the occurrence of
 cancer In test species. This  is well known
 to cancer investigators  and  we  believe
 the following answer by Dr.  Heston  to
 the  matters  raised  by  Shell  witnesses
 disposes of some of  the contentions  of
 Shell's witnesses in this regard:"
   • •  • Besides  those noted by Dr. Roe,
 there are probably many other factors,
 as yet undiscovered, which can affect the
 Incidence of tumors,  and this likelihood
 applies not only  to hepatomas, but also
 to other  tumors  as  well. And, given a
 fundamental  biological  similarity be-
 tween the mouse and other test species,
 it is  obvious  that many of the  factors
 cited  by Dr. Roe and others as influenc-
 ing the incidence of tumor formation  in
 the mouse would have a similar effect on
 other species  as well.  It  is merely  be-
 cause we  have  studied the  mouse  in
 greater  detail  than  other species that
 there  is a  greater literature concerning
 spontaneous tumors  in  the mouse than
 in other test animals.

   All of Dr. Roe's discussion of factors affect-
 Ing tumor Incidence, however, has absolutely
 no  bearing  on  the question of  carclnoge-
 nlclty. Most simply put, the question Is "Can
 the administration of Aldrln/Dleldrln to  test
 animals  result  In some  of  their  cells  be-
 coming malignant?"
   This question Is answered by selecting  two
 groups of test animals which have been bred
 under the same  conditions and which have
 similar genetic  characteristics. Both groups
 should be alike with respect to  sex: both
 groups should be tested at the same time In
 Identical  surroundings: both should be given
 the same nutrition. In ail respects except
 one, In short,  the animals of both groups
 should exist under the some conditions. The
 only difference la that on one or  more occa-
 sions, one group will be exposed to a known
 quantity  of the compound under test  and
 the other will not.
   Thereafter the Incidence of tumor forma-
 tion and other data  will  be  noted,  and
 through  statistical analysts one  can deter-
 mine  whether  any Increased  Incidence of
 tumors has occurred  in  exposed  animals
 when compared to controls. If so, and  If  the
 difference In Incidence Is  sufficiently  great.
 we  can reasonably attribute  the Increased
 Incidence to exposure  to the  compound
 under test. We  do not thereby conclusively
 prove  that the test compound "caused"  the
 elevated  Incidence, as Drs. Roe.  Stemberg.
 Newbeme and  others  would require;  if  we
 had to prove causation we could not estab-
 lish  any  substance  as  carcinogenic even
 today. Rather we must and  do make  Judg-
 ments as  to carctnogenlclty on the  basis of
 statistically-significant  differences In tumor
 Incidence arising  from  valid experiments
 such as I  have outlined above, and from other
 information at hand.
   Whether  the  particular strain or species
 of test animal chosen has a high, medium or
 low Incidence of spontaneous tumors Is there-
 fore Irrelevant so long as animals are assigned
 without bias to test and control groups. The
 fact that diet can increase or decrease  the
 Incidence of tumors becomes Irrelevant  to
 long as both exposed  and  control  animals
 am fed the same diet. All of the other factors
 cited by  Dr. Roe and  others similarly  are
 Irrelevant so long as they apply  equally to
 control and exposed test animals.
   Does the variability  In  the incidence  of
 spontaneous tumors in the mouse make It
 an Inappropriate animal for carcinogenicity
 testing? Do any  of the other factors cited by
 Drs. Newbeme, Roe. Stevenson and Thorpe
 lessen the value of the mouse In determining
 possible  carcinogenic   threats  to  human
 health? For the reasons I have given above,
 the answer Is an emphatic no. •
  " Similarly, the only cancer expert on the
Administrator's advisory committee was In-
troduced as a witness for the Shell Chemical
Company, and we feel that the record herein
totally overcomes his testimony with respect
to the significance of mouse liver tumors and
the standard by which cancer risk to man Is
determined.
  " It should be  noted that  the Shell  em-
ployee witness with  overall  scientific  re-
sponsibility  for the toxicology  programs In
Shell's Tunstall  laboratories testified  that
the laboratory  tried  to  eliminate environ-
mental biases as much  as  possible  In the
various mouse  tests  on the carcinogenicity
of dleldrln and the record does not Indicate
any such biases In the mouse tests Involved.
Also, Dr.  Heston's testimony set forth above
with respect to the  Irrelevancy of  the mat-
ters raised  by  Shell  was echoed  by other
cancer experts  herein.  Further, vtrtabllitv
In spontaneous tumor  Incidence Is found not
only m the mouse, but also In other  species
including man.
                                FEDERAL  REGISTER,  VOL  39, NO.  203—FRIDAY,  OCTOBER 18, 1974

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   In this connection. It Ic helpful to set forth
    detail coma of the testimony of Dr. Arthur
  ;. Upton. Dean. School of  Basic HcaUh Sci-
 ences. State University of New York -nt Stony
 Drool;, Net7 York,  a noted  cancer -rxi-vrt.  He
 states as follows: »
   The  emphasks  hy  .Slirll  wUnev.']  thul
 knowledge of mcch:tit!.t.Ti!i muui !>-• -\r(hicJ
 brforo  any agent ran Ije- cor.fliUj-rrn rufclr.c—
 genie, oven thouch llit.i n-^ni imi iioi-n -leni-
 onxtnitcd to Invlucu evrlnoRf nl..  .:i't-:t.i" lu
 valid experimental 'ayiitenu, e.in i-^i? iw  re-
 garded us inlaleadlni',  lit cMromc. In fa-.l, In
 »|ilti* of  A very ofm.'UI-r.iljli: Miirnnit uf  rr>-
 tcarrli,  tho hoale  iiir.rh»ni:.mj of  nrtiii.i  f/f
 liny HliiKlu corctnuc.uii hnv- nul yet 1. :rn i-lncl-
 daled.  ThLi requlrnnunl u( Cincll \vji-.l'l :ul«lllivr.t whMi "m-
 diica" cancer.
   I would like to turn nnw lo ,1 iliv:v.'.sl»n of
 the twsl.1 on which fimilniiscf cnrclno "inlclty
 nrc uuido In animal  c.rprrtmcnut!.-n. !n pij-
 tlculnr. I would Ilka  U> iidJiecs t,vm  i.n.!nvMng
 argument: Even If nn iMcreascd Lnclin'.ncc of
 tumors  Li found in test rinl'naU  a,'|.:r ex-
 posure to a particular compound, o".c ran net
 properly assert Ui^t  lhc  test  .15^11 1 "L-aiiMrt"
 the Induction of such luicnrs;  ou->  c \ii .-late
 only  that a statlstlc.il ur-wclution war. duinou-
 straUid between bdinlncLrnlloii of  11:.- com-
 putind iiid tha elcvalc-.-! lucldrncr of vi.niors.
 Onu must know  Uie  mcclianlsnu Sy r.-h.Ui a
 carcUi^fviilr. respuiixi.- I' ulicllcd  liv!^''.- r>no
 ran spcuk to tho qur.'.llon  of "cuir--i' i.,n" or
 lAbcl a teat compound n "c:urcliia;vu".
 .  X Jo not .tulj.tcrllir to this po.Miiiun. r>i r:\r-
  iiOcuiilclly U-fllliiK  tr.djy we I>3M- fic.i.'inci of
  .ruluuceiilclly on pr^ci'dj- tlio.r. si;. ti'.tli::il
 j:rll,Fi[ iliuvo
 n* InadviiiniU), nnd 1 l/rlu-vc it tint mil;  i>rr>p?r
 lint Import anl innl we du NO. Olven  '>nr prrs-
 filt   nl:iLo  of  knnwliulicn  Cutirrrnliii;   tit*
 Iiicrliitiiliiino  of  cnrrln,,|-onlrily.  1C nuif  ho
 K'jinn tlino Itfforn we inn  r^llnhty  r-iU'ilill.ili
 thn cnllrn palhwiiy from ndmliil.'ilr.ti.l.ni at n
 curclnocRiitc agent to lh<: cllcltatlriti of i\ cur-
 clnuertilc rnspoiiM*,  To  n-q\ilro U.:.'. such  ft
 pathway  b> estahlislicU  In detail  U-,'>>ie nn
 ii|;ciil mil be lalipllc-l  "rfirrlnogrnir" «-mild
 tin lit kdopt the a-.lrlrii-lliir position <•( iciinr-
 Ing fncts which  comt'Uile obvious v/ariitns
 /Inps  for huinnn heal Mi.
• A fort-moat reason  why wo cannot \valt for
 a full explanation of mechanisms o: onrcinc—
 CeiiftMs Is because of their apparrnt  multi-
 plicity and Complexity. It la no Ion,;*- rcason-
 Rblc  to  assume  that cuneer  results frc.n  a
 slucle fnctor: rather U nppein th:it rnrrl-
 noccncaja  Is  a  miilti-cnujnl.  niulU-ril.aji«U
 prorcsj In which cem-lis, hormonnl. i>ir.-lm!i-
 nicnt.il.  and other /actors piny vnr>ln;r  roles
'In the  ellcltatlon of a  particular  c-.irt.-iiio-
 Ecnlc response. At this  stage of our knowl-
 edge  It Is true thnt  we run mnke somr  pcii-
 crnllzatlons  conccrnlnR  particular fsrlors.
 We can  e.iy, for Insfuure.  that rnanmnllsn
 neon.ntrs appear to  ho  more susceptible  to
 th* actlona of some  cnrclnopens  than  older
 nnl mills; but even hrru one should noli:  thnt
 the relationship of  n£c to tumor Incidence
 nppcnrs  to vary  with Hie lype ff IHHIOT  In
 mout species slurtk-d. In man. for  liv.t.mfe.
 Borne forma of cancrr nppoar preili.minnully
 nmong  children, wlilla others wldont  appear
 among  the younq yrl Incrcnae  eiponrniluUy
 with  nee In adult*. It li bcrnu^o o( tlir.v^ nnd
 •tlitr Oinrply dlfftrrini; puttcrnj of cnurrr In-
                 52

                NOTICES'

cldence In man and  other  mammalian spe-
cies  that the process oi carclnogenesla  ap-
pears to Involve & large  number of variables
and  highly complex series  of  Interactions.
Hence It Is doubUut that vo will understand
fully tho mechanisms nf even  *^» simplest
forms of cnrctnoRenesIs In ll>» mmedlate-
future.  "  '
  I«»ca.us« of Incomplete knowledge eoneem-
Inp  mfrliniil.iiri.i, I also  du nnl licllore Ulat
dlt.UMcl.lims lietwren  "mrclnoifsn.i" and "eo-
carciii";;i-i\b". or  between "nvu.snti»«  agents"
anil  "mil indue  aijtnta" can bt» considered
reirvitul I'rflav  when nwrtnlnlnp  hazards
lo liitTT-iin  hrnlth arising irom carcinogona.
In JVifriy  t'.-ntliiG of cnrclni^irns  today wo
are ci""'*r'\i~tl with ona  (jitrutlnn: "Does ox-
po.Mirf to tur trst agent result In a nlgnlfl-
caiit Iniliirlion of tumors In ciM;ui suedes Is a confirmation of
the  uimMnoKcnicity at  tho U-st agent, but
It is not  necessary riefore a finding of
carclr.r.c.-iilcity  nnd   threat   to   human
hcsiltli cnn be mride; and nccnllva results
In rx *i:cu!ui or even third Kperlcs  of test
tuilnn! do not In my mind establish that
the  test urcnt Is not a threat for  human
bcliiti.  Given the  vnHnllun  in  human
susceptibility  to carcinogens.  I  believe
it unreasonable  to Ignore a flndlnj of car-
clnorti'iiir.'ty in any mammalian test spe-
cies  vhon considering  possible effects on
humun health."
  We Iinve limited our considerations above
•with rtjpect to tho carclnogciilclty of dleldrln
to the results la the mouse nnd specifically
la tho mouse liver. We tbuite It Is clearly a
carcuioi-.cit solely on that,  baals. (S*«  also
Part III  of'tbesa Conclusions). But. wo  are
not  re.s'.ncti-d by the record solely  to that
organ In  tho  mouse or  solely  to  that test
anlmsl. Wulle  tho effects of dleldVta wera
manifested  primarily In the  liver  of the
mou.v:, there was alao statistically significant
Increa/ves of tumors  In the lung and other
organs of the mouse  In  some of the  experi-
ments ns published and  also with the newly
introduced but  questionable revised  data.
Erwi with  the revised data, It la cleixr that
dleldrln  at low feeding  levels, at either  0.1
   "See nl&o testimony of Dr. Samuel Kpstcln
 In Ilia consolldnlcd  suspension prurccUln^s
 (KDP Exhibit Ko. 3 3).  A3 part Ilicrvof he
 atntcd:
•  '•In nditltlon,  on crosa-exnmlnntlon  this
vltnes* (iidlrnttd that mutters such as casein
and diet wlilch reflect tumor Incidence In the
mau.iff eoutd conceivably bo similarly ctvrclno-
pcnlc In ninn under certnln eruditions. On
the baiil* of our current knowledge, we clearly
cannot alnlo with certainty that tho factors
eltrd  by Shell as Influencing the occurrence
of liver tumors In the mouse cannot similarly"*
lncreo.se tumor Incidence In mab in the llrer
or elsewhere.
 ppm or both tho 0.1  aJOd 1 ppm lerels. can
 elerato the Incidence of tumors at sltca other
.than  the UTCF  and  that  this  eleratlon  U
 highly significant In either males of fcmnJes
 or  la botn sexes,  as demonstrated  by Dr.
 Gross, a veil qualified statistician  and can-
 err  expert,  by  conventional  and  accepted
 statistical analyiils. Thesa nadlngs trnd  V>
 corroborM*  the cnrclnogenlclty  of dleldrln
 In  the mouse.' as evidence*1 by the motion
 of  the mouM liver to dleldrln. tbo appllca.
 bllltr of that Qndlnj to man and to wraken
 Sl.fli's argument! baaed exclusively ou the-
 liver of the mouse.
  ALio. thort It  esrxTloiirc wltb tho nvt. We
 nre hesitantly unwilling at thtf time  to find
 that  dleldrln  Is conclusively  a  carcinogen
 In  thn  rat  nlthoiiRh  there are  Indications
 that  this Is so especially when the ehemjcnl
 l.i tasked at.tho lower doispe.i. This Is the
 CA.-
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                                                              53
                                                             NOTICES
ceptlble advanced ages after any reasonable
duration of treatment must be small and that
these patients are apparently dying of com-
peting causes before  cancer  develops or are
still too  young  to  develop  many cancers.
Although the study  was age adjusted,  the
participants therein or subjects th-jr-of were
tco young for meaningful or conclusive anal*
ysls. This Is  also the view of Dr. Marvin A.
Schnelderman.  Associate Director for Field
Studies and  Statistics,  Division of  Cancer
Cause  and Prevention, National Institute, a
well qualified blometrlcian. He further con-
cludes that "the data here are consistent with
the  possibility   that  the  anUconvulsants
which  the epileptics  received Increased  the
risk of liver cancer, perhaps two or three-fold.
Thus,  In  the case of phenobarbltone,  the
mouse may Indeed b(y) an appropriate model
for human cardnogenesis." Dr. Schneldenrmn
lists many other  reasons for  his similar dis-
agreement with Dr. Clemmesen. In short, we
do not believe that the  non-cardnogenlclty
of phenobarbltal to m
-------
   mats are not-clear, to say nnttfing of the
   stabollc processes In man. Mo one as yet
 can. draw any  valid correlation between a
 particular pattern of mfitaholl-an and the In-
 duction of canc«r In any species, and any
 judgments concerning carclnogenlclty or lack
 tnereof baaed on  metabolic patterns  have
 no scientific basis at this time." This obser-
 vation related to the testimony of Dr. Hutsoa
 adduced  by  SbeU  with respect, la part, to
 the rate  of metabolism and carcinogenesls.
 As observed  by Dr. Farber. "Suffice it to say
 that while metabolic activation Is essential
 to carclnog«uek.!3, no correlation between the
 degree of mev.bolle activation and carcino-
 genic  risie has  been established by anyone
 for any compound tested In any species to
 date." u
   IV. In  the absence of conclusive evidence
 derived from studies in """* for either the
 safety or the carclnogenlclty of aldrln/dl-
 eldrin, we are forced to make a judgment as
 to the potential hazard posed by dleldrln to
 man on the  basis of experiments with ani-
 mals. The scientific community has accepted
 the  results of laboratory experiments  with
 rodents as an Indication whether  chemical
 agents are likely to be carcinogenic In ""»".
 as has the Congress as reflected In the De-
 laney  Amendment.  Reliance upon ontmivi
 studies Is possible primarily  because  the
 pathological processes of tumor development
 in man are very similar to  those  of other
 TT.nrr.rrn.llan speCleS.
  Sollance upon «™t»n>i studies Is supported
 by experience as well as by the pathological
 similarities of man and animals. Many chem *
 icats which are known  or suspected to be
 carcinogenic  In  man were first Identified as
carcinogens In mice. These Include coal ant.
 tobacco tar extracts, polycycllc and heterocy-
 cllc  aromatic hydrocarbons,  estrogens, and
 'arbon tetrochlorlde. Furthermore, as stated
   •Her, all chemicals which are known to
  .use cancer In man also have been shown to
produce cancer  In laboratory animals,  with
the possible exception of trivalent Inorganic
arsenic which Is still under study.
  This Is not to say that the biological proc-
esses of mice and men are Identical In every
respect. Chemical carcinogens, for  example.
 may affect different target organs In different
species. Generally, however, there are suffi-
cient similarities in the metabolic  and bio-
logic processes of experimental animals and
man to indicate that on agent causing cancer
In rodents or  other experimental «jtifimi«
poses a high risk of causing cancer In man.0
  The record is replete with evidence. In fact,
overwhelmed with evidence, some of which
 has been set out above,  that such is the case
here. We believe that this conclusion repre-
sents established traditional and "conven-
tional wisdom." The Shell Chemical Company
 has strenuously and .with sophistication at-
 tempted to demonstrate that "this truth"
 does not apply to aldrln and dteldrin for the
reasons we have detailed above. We do not
  » At the oral argument herein at the close
of the hearing. Shell Chemical Company set
forth for the first time a S stage scheme for
dleldrln Induced tumor development In the
mouse- liver and contended that.4 of those
stages were only found In the mouse. Such Is
not the case.
  ** Dr. Heston. a noted geneticist with much
experience, testified as follows In this regard:
Th» Stisian population Is so  mica more
genetlcnllj diverse than  any laboratory ani-
mals  that If a chemical has been shown  tc
be carcinogenic by a significant Induction of
any kind o£ tumors In any laboratory strain
or mammal, we can reasonably expect that at
least  certain human beings would also re-
 >oart to  the chemical by  developing some
  nd of neoplasm.
                      54

                 NOTICES

 believe that traditional wisdom or science has
 been overcome thereby. Shell's presentation
 with,  respect  to the shortcomings of the
 mouse as an appropriate test ^TiifMoi nr\tt its
 lack of sig»iui««.«i.nd immediacy in view of the fact that the
 eatlre population of the United States Is con-
 tinually exposed to these chemicals and that
 dleldrln  has probably accumulated  la the
 body tissue of  almost every Individual. Dlel-
 drln Is stored In human fat, circulated In the
 blood, transferred across the placenta to de-
 veloping fetuses and secreted la human millc.
 Dleldrln Is a persistent chemical which per-
 vades our diets at  significant residue levels.
 Additionally, man Is exposed via the air and
 other  routes. No useful  purpose would be
 served and  time does not permit the listing
 In great detail*> of the quantities and extent
 of dleldrln found in humans,  in human ma-
 ternal mlllf. and In foods or describing In
 detail  the fact that the  agricultural uses of
 aldrln and  dleldrln result In much of the
 dietary exposure of dleldrln to """V It Is suf-
 ficient to state tnat dleldrln Is found In sub-
 stantial amounts In humans and In our diets
 and that  a significant source of that dleldrln
   "See  section 164.131 (g)  of the rules of
 practice. See also e.g.. Stearns Electric Paste
 Company   v   Environmental   Protection
 Agency.  461 F. 2d 393 (7th Clr. 1973): Con-
 tinental Chemlste Corporation  v  Ruckels-
 baus.  461  F.  3d 331  (7th  Clr.  1973);  En-
 vironmental Defense Fund. Inc.  v. Buckels-
 haus. 439 F. 3d 584 
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                                                                     55

                                                              NOTICES
  as substitutes for aldrin and dleldrln. Shell
  contends that "By Respondent' a late reversal
  of Ita position with respect to heptachlor and
  chlordano availability and use as a da facto
  alternative to aldrin In  1979, Shell has been
  severely prejudiced In  presentation of  Its
  ease"  In violation .of the  notice require-
  ments of 9 U.S.C. S64(b). We find no merit
  to such argument."
    The  additional  arguments  advanced  by
  Shell Chemical Company In connection with
  the availability of heptachlor and chlordane
  In 1975 are all bottomed on the premise that
  "the evidence demonstrates that heptachlor-
  heptachlor epoxlde Is as much,  or more, a
  laboratory carcinogen as aldrln-dleldrln."
  This la not the case at this time. Those argu-
  ments must fall.
    VI.' As stated earlier, our consideration of
'"Imminent hazard" with  respect/to aldrin
 and dleldrtn must take Into account "the eco-
 nomic, social, and  environmental, costs and
 benefits" of these pesticides.  In other words,
 even with respect to  "imminent hazard" a
 risk-benefit  analysis  la  required by   the
 statute. CP "e.g.. In re Stevens Industries,
 Inc.," 2 Ei,.R. 30011 (June 2, 1972), affirmed
 •Environmental Defense  Fund. Inc.  v. En-
 vironmental  Protection Agency." 489 F.  2d
'1347 (D.C. Olr. 1973):  "Environmental De-
 fense Fund, Inc.  v. Ruckelshaus," 439 F.  2d
 684-(D.C.  Clr. 1971).
   Prior to analysis of benefits, It must be kept
 In mind that'the risk wo are  dealing with.
 Is  that of cancer, a matter of grave concern.
 "Environmental Defense  Fund  v.  Environ-
 mental Protection Agency." 46S F. 2d 528. 538
 (D.C.  Clr.  1973): "Environmental Defense
 Fund v. Ruckelshaus.  supra." Moreover, we
 must  seriously heed the admonition  of the
 Court In the  latter  case wherein  It Is stated
 that tbe Delaney  Amendment to the Federal
 Food, Drug, and Cosmetic Act Indicates "the
 magnitude of Congressional  concern  about
 the hazards created by carcinogenic  chem-
 icals, and  places a heavy burden on any ad-
 ministrative officer  to  explain the  basis  for
 bis decision to permit the continued  use of
 a chemical known to produce cancer  in ex-
 perimental animals." 439  F. 2d 584, 696, fn.
 41  (D.C. Clr.  1971).
   On the other hand, we must seriously con-
 aider the 1975 com crop, especially In view
 of  the drought this year which  has  some-
 what diminished expectations, its Importance
 and the possible  effect of a ban  of the use
 of  aldrin thereon during the time It will take
 to  Issue the final decision In the consolidated
.cancellation proceedings.  As  seen from the
 Findings of Fact,  aldrin use far exceeds that
 of  dleldrtn and the major use of aldrin Is on
 corn.
  Corn Is the  world's principal grain used for
cattle, hog and poultry  feeding  and  Is  an
 important food grain as well in certain coun-
tries. We ore extremely conscious of the im-
portance of the  1978  corn crop  to protein
food  production  and  the economy.  World
grain stocks are at the lowest level In more
than 2 decades. Despite generally larger crops
elsewhere, the  smaller  than  expected U.S.
corn crop this year due to weather conditions
 will prevent  rebuilding  world stocks this
year. It'will be necessary to await next year's
 crops before there can be hope of rebuild-
ing such' stocks.
   But, we do not believe that the availabil-
 ity of aldrin or lack thereof will significantly
 affect the 1973 corn crop. Stated another way.
 It  appears  to us from the record  that the
 necessity for aldrin In the production of that
 crop and the  consequence •of  Ita  unavail-
 ability have been exaggerated.
   To place our  Inquiry In proper perspective,
 It should be noted that aldrin Is utilized on
 only approximately 8-10 percent of the acre-
 age devoted to corn production and that some
 of  Its  use thereon  Is  actually  unnecessary.
 In other words, aldrin Is often applied as
 "Insurance." As with  much Insurance,  the
 covered risk does not  occur and would-not
 have occurred even In the absence of the In-
 surance coverage. This Is  not to say that In
 certain  situations  the need for Insecticides
 Is not more apparent than In others. In ad-
 dltton. there Is  some evidence of record  that
 corn soil Insect populations are  at low levels.
   Dr. John Schnlttker, a former Under Secre-
 tary of Agriculture of the United States who
 has much experience and expertise  with re-
 spect to the economics and marketing of feed
 grains  testified on behalf of respondent In
 these proceedings. He assumed, for the pur-
 pose of his testimony, that  the absence of
 aldrin  would result  In a 1.  2 or 3  percent
 diminution, in  the corn  crop and projected
 the consequences of such, reductions.3
  Dr. Schnlttker's  testimony Indicated  that
 the overall economic effects of-the ban of
 aldrin for use of corn depend to a great degree
 on the extent of the future demand for grain
 Imports which will b» placed on the United
 States  by other countries, as well  as on a
 variety of facts affecting  the supply -of corn,
 such as the supply of suitable land, tech-
 nological developments In corn breeding and
 husbandry,  demand  for  other  agricultural
 products under soil and climatic conditions
 to which com Is well adapted, federal farm
 programs, weather conditions and fertilizer
 availability.  The  unpredictability of sucn
 factors aa weather make  projections about
 future  com  harvests In  specific years   ex-
 tremely difficult as the recent drought In  the
 corn belt demonstrates. In this  connection,
 however. It appears to us that the reduction
 of  the  I9T4 corn  crop below  expectations
 would, In terms of Dr.  Schnittker's analysis,
 result,  in  effect,  in  shifting. In part,   his
 estimates and consequences for  1974 to 1976
 since the same basic capability to produce a
 corn stockpile  from next  year's  crop would
 remain.
  Dr. Schnlttker concluded that the current
 situation prevailing In the grain market Is
 abnormal and short term, resulting from the
 somewhat unprecedented  crop  shortfall of
 world grain In  1972 and 1&73 which necessi-
 tated a depletion of accumulated reserves. He
 predicted a general reduction in the Import
 of grain by all countries because "the magni-
 tude of the decline) in world grain production
 In 1972 appears  to have been principally  the
   3 As Indicated above, there was no reversal
 of position with respect to heptachlor  and
 ehlordane availability.
  9 Such testimony was received 'In the can-
cellation  proceedings, and his  projections
were not specifically related to the 197B crop.
Nevertheless, they are valid for these suspen-
sion proceedings. In  any event,  we cannot
conceive of a 3, 2 or perhaps even  a 1 percent
reduction in the 1975 crop  by virtue of the
absence of aldrin. There Is In reality no good
basis  In the record to predict such a  loss
probably approximating over 60, 120 and 180
million bushels of com at the 1, a and 3 per-
cent reduction levels, respectively. (See dis-
cussion which follows).
  result of events which should not be expected
  to recur regularly." He further  stated that
  "the>  analysis  of  agricultural  production
  potential and targets  •  • • leads to the con-
  clusion that success In expanding production
  Is possible  and probable In most  countries
  and that U.S,  grata  exporting capacity  will
  not be tested every year until the end of the
  1970's."
   In short.  Dr. Schnlttker found very little
 macroeconomlo effect of even a 3 percent re-
 duction  In   corn  production, a reduction
 which he considered  to be well beyond  any
 known estimate of the actual Impact to be ex-
 pected from the unavailability of aldrin. We
 are in full agreement with both of these con-
 clusions. This Is not to say that we are not
 very concerned  about possible effects  of sus-
 pension upon Individual fanners,  a  matter
 we shall discuss in the next part  of these
 Conclusions.
   While predictions and projections ore haz-
 ardous for obvious reasons, It appears that
 the planting of additional  acres to compen-
 sate for any reduced yields  would nullify any
 price impact at the national level and even if
 no additional acres were planted to offset any
 yield Impact the price of corn would Increase
 by only 1.5 to 5.8 percent for the 1 and 3 per-
 cent reductions.
   But, as indicated by footnote 29, we do not
 believe that a  3 percent reduction In yield
 could  result  from  the absence of aldrin in
 1978. In fact, we seriously doubt that even a
 one percent decline would result.  We have
 been casting about In these proceedings for a
 reliable  estimate of the reduction In yield
 that would be attributable to a suspension or
 cancellation  of  the use of aldrin In the pro-
 duction of corn. One of the  obvious  problems
 In  this connection Is  an Inability to deter-
 mine what would have been the case If aldrin
 had not  been used. Aldrin Is In part utilized
 by farmers as "Insurance" and may  not have
 been actually necessary at least In some very
 substantial number of Instances.
   We totally reject the  Doane Agricultural
 Service,  Inc. special survey and projections
 of loss adduced by the Shell Chemical Com-
 pany. On Its face, It la patently exaggerated,
 employs  "double counting  compounded." Is
 based on a small sample from which amazing
 projections ore made and elicited the views of
 aldrin  users  who would not In reality,know
 with any precision  the effects of the absence
 of aldrin and who, It seems  to  us,  would
 demonstrate  a  bias.  Such  survey,  it  also
 seems  to us, was  biased In Its design,  re-
 sponses and presentation of the survey ques-
 tionnaire and results  and  displayed other
 weaknesses  such   as  statistical  deficiency.
 Similarly, the very rough study of Dr. Freund.
 which  was only Intended to  be a tentative
 and preliminary work, cannot be relied upon
 as indicated  by  the report Itself which states
 that "the assumptions are extensively quali-
 fied and for  firm conclusions,  more data on
 many aspects of the study are needed."
  It appears  to  us  that aside from the mat-
 ters mentioned above,  the only economic
 study offering some reliance  Is that  of  Dr.
 Herman  W,  Delvo, Agricultural Economist.
 National  Economic Analysis  Division, Eco-
 nomic  Research Service, United States De- '
partment of  Agriculture, entitled "Economic
 Impact of Discontinuing Aldrin Use in Corn
 Production."  Issued June 1974. Dr. Delvo uses
 data accumulated from the  USDA 1971 Farm
 Production Expenditure Survey to establish
 the use pattern of aldrin In 1971. He  relies on
 consultations with entomologists In the Corn
Belt states to estimate overall losses In the
event that aldrin. heptachlor and chlordaoe
                                  FEDERAL REGISTER,  VOL  39,  NO. 203—FRIDAY, OCTOBER  18,  1974

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                                                                 56
   .» not available for use.9 Dr. Delvo esti-
mates that the overall loss In 1971 in corn
production, would  have  been.  19 million
bushels for tae Cora Belt states and a total
of 21 million bushels tor the entire nation
where farmers nuke use  of alternatives to
aldrin (Bus, M» footnote- 30). II farmers did
not  us» alternatives, he estimates the 1971
1034  at 51 million bushels for the Corn Belt
states and a total of 93 million bushels for
the United States. Even adjusting for 1975 In-
creased acreage over 1971 acreage  and con-
sidering the fact that, perhaps, use of aldrtn
for rootworm control  majr have been over-
stated,  the  o-itlmated loss  In  this  study
where farmt.-i utilize alternatives Is much
below one percent of estimated production
and may reach one percent If alternates. In-
cluding  heptachlor  and chlordane. are not
used, a situation which Is Improbable."
  Confirmatory of the general conclusion of
Dr. Schnltiker. Dr. Delvo found very little In
the  way of macroeconomlc effect  resulting
from the absence of aldrin as  an Input in
corn production. In fact, he found a 0.8 per-
cent Increase In price with use of alternative
Insecticides and a  2.2 percent  Increase  In
price without alternative Insecticides  with
fanners showing a net gain.
  On the bests of the foregoing, we  cannot
And any major economic or social benefit re-
sulting from  the use of aldrin  on corn In
  * In the consolidated cancellation proceed-
ings  heptachlor and  chlordane, which are
admittedly as effective as aldrtn. were we
proposed as alternatives thereto and our con-
siderations therein were limited to alterna-
tives to aldrin other than these 2 Insecticide?.
It appears, however, that approximately 3.-
000.000 and  1,000.000 pounds of technical
  -atachlor and  chlordane, respectively,  will
   available for use. on corn In 1975. We can-
-ot ignore such fact In assessing the effect of
a suspension of aldrin on the 1973 corn crop.
Consequently, Dr. Delvo's estimates must be
considerably reduced since he did not Include
heptachlor or chlordane In arriving at his
conclusion. In reality, his estimates of loss If
farmers used alternatives must be reduced.
perhaps by 20 to 40 percent or more as testi-
mony  In these  proceedings  Indicate  that
farmers would switch to heptachlor and per-
haps, chlordane. the efficacy of which Is not
In question. In addition, such estimate was
basvd on  the supposition that the other al-
ternatives would not be as effective as aldrin.
This may not be so at least with respect to
newer alternatives for use against the wire-
worm. We make  further  observation  that
many  and. perhaps  most farmers  do  not
apply aldrin as directed for heavy wtreworm
or cutworm Infestations and losses from such
infestations might not be so different  with
aldrin or an alternate treatment. Also, we
note  that some of the entomologists  with
whom Dr. Delvo conferred have testified in
these proceedings for Shell or for respondent.
  n We do not at this time know cora plant-
Ings for 197S but we assume that they should
approximate 1974 plantings and that produc-
tion estimates should  be  similar for  both
years especially In view of the present price
of corn. In this connection, we also  believe
that most farmers wilt use alternate  chemi-
cals, even If more expensive than aldrin. be-
cause or (he  favorable price picture and the
fact  that pesticides  represent  a relatively
small part of the  cost of production. In an/
erent. we cannot make estimates of. or on the
basis of. failure of farmers-to use alternatives.
V.v-.t  Importantly, we do not necessarily agrt -
by  nrtue of the  above analysis that losses
woi-.ld be as high  as'stated by Dr. Delvo. We
*.ave merely used his paper as  a frame of ref-
  •ence. We believe that Dr. Dejvo may have
  verestlmated losses  due to  wlreworm  and
cutworm  damage.
                 NOTICES

 1973 In the context of overall effect of lt»
 unavailability for such use. In other words.
 we could not  meet the burdsh placed upon
 us for continued use by the Court in "En-
 vironmental Defense Fund -  Ruckelshaus."
 supra at footnote 41." It w.vii-j be strange.
 Indeed, to allow the use of aldrin  for  the
 197S  corn crop  and thereby continue to
 jeopardize the health of the American people
 in order to place a relatively  small amount
 of corn  into  the  world stockpile. Concern
 expressed for starving people abroad can be>
 met or satisfied by other moans it seems to
 us. if necessary.
   VH, We turn now  to  the Impact  of  the
 absence of aldrin upon Individual corn farm-
 ers, also a matter of great concern. It must
 be remembered In this  connection  as well
 that  considerable Quantities  of heptachlor
 and chlordane will be available In 1975 and
 those farmers who feel a need for aldrin may
 avail  themselves of these alternates to some
 extent.*3
   Initially much was said  of  the  "com soil
 Insect complex" consisting of some 20 soil
 insects that attack corn. Upon analysis, how-
 ever, it appears that there are generally only
 3 and possibly 4 Insects that can be of eco-
 nomic significance with  respect to damage
 to corn, namely,  the corn rootworm, cut-
 worm, wlrewonn and. perhaps, the white
. grub. These  Insects  have varying  degrees
 of importance. Tha other soil insects attack-
 ing corn are  not usually  even treated  for
 with pesticides. Shell Chemical Company did
 not include them in a proposed or suggested
 limitation on use offered by It In these pro-
 :eedlngs and we shall confide our considera-
 tion to those Insects specified above.
   The corn rootworm Is by far the major corn
 soil Insect pest In the Corn Belt and attacks
 continuous, as distinguished from, first year
 corn. Two of the 3 varieties or species of the
 corn  rootworm, .that is,  the Western  and
 Northern com rootworm, are  now resistant
 to aldrin and.are found In much or most of
 the major corn producing area of the coun-
 try. There are many organophospbate and
 carbamate Insecticides which effectively con-
 trol the resistant'corn rootworm and alsb the
 nonreslstant  variety.  Consequently, we  do
 not consider the com rootworm In our deter-
 mination with respect to the need  for aldrin
 as this pesticide 13 not used la much of the
 Corn Belt for  the control of this Insect and
 to the extent that It is so utilized to control
 the  nonreslstant  com  rootworm it may
 readily be replaced by those chemicals em-
 ployed to control the resistant variety.1*
   The next major  soil Insect pest  of corn is
 th,e cutworm and we shall discuss It below.
 The wlreworm  and. perhaps, the white grub
 are also economically significant pests of com
 but to a much lesser degree than  the root-
 worm or the cutworm. On the basis  of the
   * Shell Chemical Company In Its  pretrlal
 brief  in- the consolidated cancellation  pro-
 ceedings did not.  la  reality, contend for a
 maeroeconomle effect  resulting from  the ab-
 sence of aldrin and several 01 the entomolo-
 gists called by Shell as witnesses agreed  that
 its unavailability  would not have such an
 effect in their states.
   D We do not  consider ' i these suspension
 proceedings,  as distinguished from  a, can-
 collation proceeding, sucl  basic questions as
 biological control wlthov  the use of  Insecti-
 cides, possible  new res^tanee of insects to
 aldrin,- possible resurgence of Insect popula-
 tions absent aldrtn, etc.
   »Respondent advances  a  theory that the
 substitution  of organophosphate  and  car-
 bamate Insecticides for aldrin for control roceed!ng they
property   must  be  considered   as  viable
alternatives.9*
  Additionally, as we have stated, the wire-
worm is  generally only a significant problem
to the individual farmer when certain rota-
tions are followed. Since' we are only  con-
cerned herein with the 1975 com cropl'the
fanner.   If he anticipates  problems  In  the
absence of aldrin and does not care to apply
or cannot obtain one of the possible alter-
natives Including heptachlor and chlordane,
may to a large extent solve his problem by
the rotation  he chooses."' For  example,  a
farmer may grow soybeans a second  year, a
crop which is not greatly affected by  the
wlreworm. or  may plant sod  or  pasture in
soybeans rather than starting- Initially In a
corn-soybean  rotation, although  there Is
probably very little sod or pasture now avail-
able. However, the corn-soybean  rotation Is
probably the most insect free and. does not
present  a great wlreworm problem  In  the
rotation  from soybeans back into com. We
recognize that this  may  somewhat restrict
some relatively few farmers, but, in the con-
text of these proceedings, such restriction Is
necessary. As  much of the corn land Is in
continuous corn, we do not believe that great
number? of farmers are  faced   with  this
choice absent the availability of aldrin in
1975.
  The insect which gives us most concern In
connection with its affect upon the Individual
  "We cannot, it seems to us, consider prom-
ising alternatives  that are; perhaps,  in  the
"registration pipeline" but are not  as -yet
registered. Mention  should bo made, how-
ever, of section 3(f) (2) of the act (7 U.S.C.
136a(fJ (2)) which provides, to part, that "as
long as no  cancellation  proceedings  are In
effect  registration  of  a  pesticide shall  be
prtma facie evidence that the postlcult. its
labeling  and  packaging  comply  with  the
registration  provisions  of  the  Act.-   \Ve
should state, however, that promising Addi-
tional alternatives ore In f •? "pipeline" anrt
we surmise that they probably will be regis-
tered for the 1975 season.
  * Alternatives, other than heptachlor and
chlordane. are listed In the Findings of Face.
We do not rate their respective merits. The
farmer concerned  about  wlreworm damage
.oust consult his state extension entomologist
for recommendations with respect to his In-
  " Rotation can also  solve the problem of
the blllbug and white grub to a great degree.
                                   FEDERAL REGISTER, VOL 39, NO. 203—FRIDAY1.  OCTOBER  18,  1974

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                                                           57
         U the cutworm. Unlike tbe wlreworm,
    in  cutworm la  generally a  problem asao-
    mtad with gcueriiphy. soil »nd weather. In
  other words, Uio  cutworm  la an/violated gen-
  etully with poorly ilrtUnrd river bottom land.
  heavy tolls and low wet spots In upland fields.
  and  rotation docc not play a majcjr_role in
  connection ihtrewitn except to some eitent
  on Oral year turn following sod or legumes.
    There dose not appear  to now be an effec-
  tive preplan! or planting lima Insecticide tot
  Ui« control or  tlie UlacK cutworm. nltbouRA
  oeveral Inaecttclim  with  unknown elfeetivo-
  ncia are lu tho 'registration pipeline."  in-
  •lend. tb«  currently available allcrnstlve to
  ahlrla preplan* ucntment under  curn  Is the
  application of ;«. •' :-uieruent spray: and. baits,
  that la,  after  Viic  Insect  baa actunlly  ap.
  peored.  Phllo.io|iblcally  and  aa a  practical
  matter, this method of treatment nan tbe ad-
  .vantage at  treating (or Known Insect lufeaU-
  tlon  and the  avoidance  of an "Insurance"
  treatment  of entire  flokls  where the Insect
  may  not appear,  miiy ouly attack part of a
  fluid  or nny appear  but  not In numben of
  economic slgnlfiuuiica.
    An  entanioln;l.<.l  prenented by  tho  Shell
  Chemical Company imU others tcntlflcd that
  tbe poet ouicir.viit halta ere u clfcctlvc as, or'
  bettor, than, a one  pound  per ncro hand or
  row application of  aidrtn  against  the cut.
  worm which l»  not a* effective u & 3 pound
  per acre, broadcast application thereof. The
  lower rate  of  application  or  sldrln Is not
  effective against a heavy  black cutworm  In-
  fcatMlion,  but  mauy. If  not  moxt, of the
  fanvern  apply aidrtn  at  tho  lower rate. In
  other words, they nre willing to settle for lu*
  than tho best Uentmcnt. Thla cho\ild bo a
  factor, perliaps, in evaluating the sprays and
  baits aa substitutes for akJrin and the actual
  •ecesalty for any treatment.  In auy event,
   \e record supports the conclusion that post
  ..nergent treatment of blade  cutworm, tbe
  major cutworm pcit,  with bolts Is efficacious
  with post  emergent  sprays  having  lesser
  effectiveness.*                        '
    nowerer,  post emergent treatments for th«
  blade cutworm has several difficulties or dis-
  advantages. In onler to bo effective as altar-
  natives to  preventive preplant or planting
  time  applications of  aldrln.  the baits  or
  sprays must be  timely Applied. Thh requires
  that tbe farmer observe his field* carefully
  during aa approximate 3 to 4 weak period
  when the oorn  lx.-«lns to  emerge.  This does
.  not mean tlukt all  farmers need obsnrve  their
  fields or that those  farmers with a auwicct
  cutworm prolilotn ncvd  observe  all   their
  fields. It  does mean  that  the fainter  wbo
  hoe had  cutworm problems  In  the recant
  .past must chock fcey survey  spots in hlj sus-
  poot  fields.  While  a 6-atata cooperative
  survey  Is  dorelopluf   a   scouting   sys-
  tem, we are nol,  we  believe,  at  the  point
  of  hitting  avBlUitla  commercial  scouts  or
  commercial  scoutlnu  of  farmers  fields for
  cutworms. Bather, the Individual fanner, his
  family or  employees  er  even' high school
  students could scout or wallc select portions
  of corn fields In an attempt to detect early
 elgns  of  cutworm damage.  Such damage la
  more   readily  rucogulTable  than  damage
 fcaused by other Insects. We recognize  that
  tola Imposes  a burden on tba  farmer  at
  perhaps bis busy time of year.
   Concomitant with  early detection of  cut-
 worm Infestation  Is  the necessity for rapid
                 ;. NOTICES

  treatment wltfc balta of iprari. II tbe farmer
  ooacrrea early cutworm feeding damage he
  has several day* in which  to apply a bait or
  spray inaectlctd* to protect  th« crop. The
 •balU will then prevent further loss of *tand
  and auy cut  corn will huve- an opportunity
  to rogrow. However, unrirr pitrrme dry or wet
  corMTHoos, the 'bait'' Insecticides  may  lose
  •erne of their effectiveness. An entomologist
  presented by  respondent testified that  75 to
  80 percent of the Illinois com farmers have
 .obtained good to excellent black  cot-worm
  control with peat emergent baits.''
    As con be seen from me prior discussion,
 the  use of  post  emergent  baits  and sprays
 in lieu of  aidrtn presents  extra effort  and
 some- additional uncertainty. We do not want
 to leave the Impression, however, that cut-
 worm lora Is Irreparable. Should  a  Held or a
 portion of  a died suffer  sertoua  cutworm
 damage, tho  farmer  nan  the option of te-
 plontlng corn thoreon. In fact, thli  la usually
 done. It \a  recognized that In tliirt «v«nt tho
 farmer  suffers the coati of replanting  and
 «uff«n»  some loss of  yield  due to  the  later
 planting. But, with the current price of corn.
 the farmer will most Ilkriy receive a pron table
 return from his corn production, which re-
 turn will, of course,  he reduced  from what
 Jie would have experience*, in fact, a farmer
 may Initially  plant  corn  later  on suspect
 acres and,  perhaps,  avoid  cutworm lulury.
 In thin  event, he would nutter some loo of
 yield due to lat»  or later planting.  In  addi-
 tion, heavier seeding Is also a valid measure
 the farmer can take.
   Farmers  generally are. not  thnt familiar
 with Iho use of nost emr-rijrnt treatment* or
 with scouting. There spnears to us adequate
 time to prepare  for such  matters  prior to
 plantln; time In  1978 which shall  probably
 betrln iiroundAorU 13. J973.
   We do not lightly  make  these  nndtaRs us
 we do not desire to cause additional burdens
 and uncertainty to farmers  who havs- a his-
 tory  of  cutworm  problems.** But. It appears
 to us that there Is a relatively adequate al-
 ternatlvn to aldrln In tho treatment of tho
 black cutworm and therefore we cjinnot con-
 clude that during 1873 aldrln use should be
 continued  for  thla purpose  In view of our
 conclusions  as to the risks accompanying
 aldrln." We  do not expect  the corn farmer
   "Most liatea now recommend the  post
  •nergent treatment  as an  emergency treat-
   ent. It should be stated at this point  that
  /Iseonsla has  banned the use of aldrln on
 corn and that tho Illinois state recommenda-
 tions do not Inculdo aldrln. Instead, the post
 emergent treatment Is recommended.
   "The  snndhllt and  glassy cutworm cnuje
 special concern  aa they  arc  .tubterranean
 feeders and the bait Is prnhahlj Inadequate.
 These cutworms aro nol u-tdospnuid uid there
 Is sonic  Indication In  the  record  that band
 treatment of Dunhau, Dyfoimle. Mocnp  and
 Dlazlnon could be effective u to Diem.
   * Another, uncertainly presented ' for  tho
 record la the availability of the alternate In-
 secticides In 1973. There need not be a pound
 for pound  displacement especially with re-
 spect to post  emergent treatment. Hepln-
 culor and chlordane ore available. Insect pop-*
 ulatlons  appear to be nt low levels, rootworm
 Insecticides  rjlvo  tome  control of wlreworms
 and perhaps cutworms and oltlrtn has been
 overused In  the past. We agree luat the situ-
 ation will be tight. We olio believe, however.
 that this decision will generate some addi-
 tional alternate pesticides to the extent that
 Is possible. Also, any existing stocks of oJolrlu.
 if any,  could  be  utilized  and  the   Inter-
 mediates contracted for by Shell could pos-
sibly  be  available for additional hcptachlor
production.
  " Some of the parties primarily In tbe can-.
cellatloa proceedings  have  taken  the view
that proposed alternatives need be aa effica-
cious as,  and no more costly than, tbe chem-
ical at Issue. We reject aucli a standard  es-
pecially whan the risk at band is aa ominous
a* cancer.
   wbo haa cutworm problems to Uio this con-
   clusion,  we have, perhaps,  imposed some
   oooroua  burdens upon him. The  act nukes
   this requirement.  w«  believe.  If the  post
   emergent alternative  Is  not acceptable to
   some farmers of bottom land, they have Ux«
   option., per tisps, of plnjitlng other TMdfrops
   during  lhat •MaoSHTmbTwnn'ff "Soyoeana
   whJcb, Is another. Important feed crop. Should
   •ome of thla acrcaco be lost to corii In 1078.
   U»e replacement thereof by wmc  other feed.
  • crop Is merely  a trsdo off w» believe.
     To summarljo, we cannot  Justify the  uiu»
   of aldrln  under corn  In  1975 botii from •>
   muCToeconoralc  or  mlcroeconoinlc  stand-
   point.
     VIII. Aidrtn la also utilized for  control of
   the F'uller Ro?e Beetle In Florida, one of  the
   more minor  citrus pests In that State. While
   sales statistics adduced by the Shell Chem-
   ical Company Indicate that this Inseetlelcto
   Is sold  and used OT cltnis In  murh  of Flor-
   ida,  expert  wltneetoa  presented  by Florida
   Citrus Mutual,  n major grower or^nnl/ntlon.
   Ustiaert  thnt  the economle  ilgnlflcance  of
   the Fuller Resv 13»«tle la very elrHimxerlliert
   freofrrnphlcxlly In ihut Stita. Of the 1)77000
   acres of citrus in Florida, the rose beetle la
   only present In  numbers lulflrtpnt to com-
   mence to reduce yield on between 10.000 mid
   90.000 acres. The urea of I'irninfant  Infesta-
   tion is  essentially the Indian Rlrer arcn  of
   the Southeastern irnljonrd of Florida, fui area,
   characterized by poor Internal soil dralniVKe.
   a high water table, and consequently unusu-
   ally shallow cltnts root systems. L«ss  thru*
   S percent of  the total citrus acreage in Flor-
   ida lias been treated -with any soil Insecticide
   for control of any Insect and even within tlie
   Indian River Fuller Rose Beetlo trouble re-
   gion only 30  percent of the acreage hnj beoa
   so treated.
    In,  a tvpleal Indian River grove, approxi-
   mately 73 percont of the feeder roots of citrus
   trees ore located wllhlu 10 Inches of the top
   of the, ridge  of sou upon which citrus trees
   are usually planted In that are*. Such  trees
  are distinguishable by particularly restricted
  root systems  with unusually  limited  sup-
  plies of feeder roots. These systems are leu
  able to make do wjth decreases In  root pro-
  ductivity r«ultlug from Imcct damage which
  would  be  Insignificant  in   other regions
  within the State of Florida.
   .Aldrln Is overused on citrus to some extent
  In  that It Is unnecessarily utilized.  Substan-
  tial reduction In frop  yields  caused by lack
  of  treatment for tho Fuller Raie  noetle 1«
  relatively rare when the Industry Is consid-
  ered on a whole.
    Aa indicated In the Findings of Fact, cul-
  tural  practices offer  a large  potential  for
  disruption of  pest problems caused  by the
  rose beetle and alternative Infectlr'.dnl follnr
  sprays, most of which are already u.«od In the
  Florida citrus program, some as often as 4  to
  6 times a year, provide good Initial kill of the
  adult weevil. The State of California docs not
  recommend the use of aldrln to control the
  rose  beetle on lt» very substantial citrus
  acreage and-a large Florida citrus grower or-
•  ganlzatlon does not utilize It.
   Once again, we  need  put the  Issue with
  respect to tho continued use  of  aldrln or
  dleldrin on Florida citrus In perspective We
  are  presented herein  In. these suspension
  proceedings with the limited question of lu
  continued use. during the time It voiild take
  to complete proceedings relating to cancella-
  tion of such  chemicals. We are  talking,  it
  seems to ns. of one split application of aldrln
  or at most one annual application thereof.
   It Is clear from the record that In view of
  the limited area of possible need uid. In re-
  ality, the  limited  number of  orchards  or
 tre« Involved, tbo  absence of aldrln during
 the restricted  p«rlod of eonaldoratlou wbulU
                                  rtDHAl  reOISTM, VOL 39.  NO. JOJ—«IDAY, OCTOBER  18,  1974

-------
 h.   little.  If any. affect upon the Florida
 citrus Industry or the price for Its products.
 Additionally, we see  very little effect upon
 the relatively «man number of possibly af-
 fected growers. Cultural practices and foliar
 Sprays are available to  them as alternatives
 :> oldrta or dleldrln."  Further, we surmise
 that existing stocks of these products, the
 use thereof not being barred by the Adminis-
 trator's  August 2, 1974 notice of suspension,
 may well be present In Florida to some ex-
 tent. In  short, we see no overriding benefit
 or any great disruption from the nonavaila-
 bility of aldrln or dleldrln for Florida citrus
 during the- nex. growing season."
   IX. Aldrln : . 1 predominantly dleldrln are
 also used for seed treatment-or dressing on
 many different types  of seed: The record Is
 not as complete with respect to the need for
 these Insecticides In the treatment of some
 seeds as distinguished from others  or with
 respect to seed treatment generally. Certain
 generalizations  can   be  made   however.
 Farmers will purchase seed after It has been
 treated  commercially, will  treat the  seed
 themselves prior to planting,  often as  part
 of a slurry  or liquid mixture, or will add
 the chemical directly to the seed In a planter
 box at  the   time  of  planting.  Commercial
 treatm«nt of seed is more practical, tending
 to provide a more even and effective distribu-
 tion of relatively small quantities of Insecti-
 cide, particularly In-contrast to individual
 grower's  applications  by means  of  planter
 boxes.
   Dosages vary according to the type- of seed
 treated and  the seeding rate per acre. Under
 normal conditions or  circumstances, aldrln/
 dleldrln U applied to seeds at the rate  of
 one-half ounce to ona ounce of the chemical
•per bushel  or per 100 pounds of  seed. The
 cc»t or  seed treatment with  these  Inseett-
 '     is  relatively smalt and.  In  some  In-
     .63.  is not passed on to the farmer.
   Dleldrln has an effective life as a seed
 dressing  In  soil of approximately 10 to 20
 days. In warm  or hot weather, seeds will
 typically germinate In 4 to 8  days, but  In
 cool, damp weather germination may be de-
 layed to a week or 10  days. Most of the seed
 dressing alternatives advanced by respondent
 are less persistent than dleldrln and provide
 less of a margin of protection. Llndane ap-
 pears to  be  an effective alternative  but for
 some criticism of a delay In germination of
 the seed resulting from its use. This ap-
 parently occurs if the seed has been treated
 with llndane sometime,  such as 3 weeks, be-
 fore planting.  A simple  answer to  this
 criticism Is   a  planter box  application  of
 Ilndane by the farmer at the time of plant-
 ing. This process, of course, has some of the
 disadvantages mentioned above.
   Here too.  however, we find no compelling
 macroeconomle  or mlcroeconomle reason
 necessitating the use of aldrtn or dleldrln
 see:' treatment during the period it will take
 to complete the consolidated cancellation
 proceedings.  Several  viable  alternatives  are
 available.
   °We have some hesitation  or reservation
 with respect to some possible disruption of
 an Integrated pest management control sys-
•tem employed In Florida In the control.of
 other  Injects by the use of alternative foliar
 sprays. We are not aware that this would
 necessarily occur however.                •  •
   "Two  other weevils of lesser  economic
 consequence than the rose beetle were men-
 tioned in the record. AU we have said with
 respect to the Fuller Rose Beetle Is appllca-
 b1- thereto. In addition the dlaprepes abbre-
     is eradication program has available to
     .Feral alternatives.
                   58

                NOTICES

  X. In  the consolidated  cancellation pro-
ceedings, the United States 'Department of
Agriculture defended the  continued us* of
aldrln and dleldrln for certain uses la addi-
tion to those discussed above and It similarly
does so here. These Include such uses of ono
or -the other of  these. Insecticides as  oa
Puerto Slcon pineapples,  sugarcane  and
bananas, onions grown In the Tulelake TL*MI«
of Northern California, strawberries In Ore-
gon  and  Washington,  .the  Department's
quarantine program, cranberries and nursery
use.
  The parties, that Is, in this  connection.
USDA, respondent. Environmental  Defense-
Fund,  Inc. and  the National Audubon So-
ciety, are. la  effect, attemtping to place us
In the straltjacket of deciding the ultimata
Issues presented by the uses Involved In the
consolidated  cancellation  proceedings. We
refuse  to be  so restricted. For this reason
the briefs filed by these panics do not. In
great measure, really address the problem at
hand.
  We have stated several times  In this De-
cision  that we are solely presented with the
continued use of aldrln/dleldrin during a
relatively limited  time frame,  the  time it
will  take to complete the  cancellation pro-
ceedings. We do not Intend to consider mat-
ters  beyond that period  In this Decision.
In addition, the briefs of these parties with
respect to these uses do not deal with the
significance of the availability of heptacblor
and  ehlordone In 1975. For the most  part;
the parties attack  the Issues as If hept'achlor
and  chlordane do not exist. This is absurd
»nd  we have  no Intention of deciding the
i.uestlons posed herein -as if they  do not
9 Oat because the ".real world" situation can-
not be Ignored.
  Heptachlor  and chlordane were not pro-
posed as alternatives by respondent and the
Environmental Defense Fund for the reasons
explained earlier.  But,  these chemicals are
here and are registered for  many of the uses
defended by, USDA. In reality, USDA does not
challenge or question the efficacy of these
insecticides for most of their registered uses.
In fact, it recommends the use of chlordane
In Its regulatory  and control programs and
"dleldrln  is reserved for those limited uses)
involving soil  surface treatments • •  • where
chlordane will not render  the required 100
percent control. « • • This reflects Depart-
mental policy requiring that chlordane be
substituted for dleldrln wherever possible." "
  We need not  analyze each of the USDA
defended uses and the  need for aldrln or
dleldrln  thereon.  Heptachlor or chlordane
are registered and effective  for  such  crops
or uses aa pineapples; greenhouse, nurseries
and nursery turf, onions, perhaps strawber-
ries, sugarcane and apparently bananas. Ad-
ditional  substitutes are also  available for
some of these and other uses. Also, there are
alternatives In the "registration pipeline"
which  we surmise  will receive priority.
  It can also  be stated with respect to the
uses Involved that we see no major food sup-
ply problem and certainly no macroeconomle
effect from the lack of aldrln or dleldrln. la
  M Chlordane surface application is admit-
tedly effective for nurserymen where  certi-
fication Is vnnecessary. The alleged need for
dleldrln surface application in  limited cir-
cumstances for  certification status for a 4
year period can. surely be solved by USDA
during the limited period Involvid herein-If
only by an additional application of chlor-
dane. This circumstance should not arise
often during the limited period and we are
certain that administrative adaptability ant*
ingenuity  will  easily  solve  this temporary
problem.
  fact, the cranberry industry Is currently suf-
  fering from a glut or oversupply. Also,  we
  Bee no  substantial mlcroeconomle conse-
  quence from the absence of these pesticides
  during the limited period at Issue. Actually.
  the absence of any Insecticides In some  In-
  stances will not have effect for some years.
 •It must be realized In this connection that
  aldrln or  dieldrln  are not  used annually
  with respect to most of these crops and  the
.  affected  growers represent a small segment
  of those Industries. For example, a minimum
  of S year protection Is claimed with respect
  to cranberries. In short, we believe that  the.
  growers Involved can manage for one season,
  at most  without aldrln or dleldrln but with
  the alternatives at hand. As to some of these
  growers, a different crop rotation Is available
  If they are convinced that they  cannot do
  without  aldrln or dl«ldrtn and cultural prac-
  tices are available to negate or minimize  the
  absence  thereof.  For example, flooding of
  cranberry  bogs can eliminate the insect pest
  or peats."  to addition, to the extent existing
  stocks of  aldrln and dleldrln are available.
  they may be used.
   To  summarize,  there  clearly  does  not
  exist any compelling reason to make aldrln
  or dleldrln Available. In 197S for the uses de-
  fended by USDA. We are no^. hereby saying
  that our conclusions with  respect  thereto
  will be the same In  the consolidated  cancel-
  lation proceedings when we assume that hep-
  tachlor. and.  perhaps,  chlordane will once
  again not  be considered as alternatives. We
•  con foresee, for example, a possible conclu-
  sion calling Tor continued use of aldrln or
  dleldrln at least for a limited period  of time
 .while alternatives are found. The record dem-
  onstrates In most Instances Inaction or inade-
  quate  action In  this regard.
   In addition to all of the uses of aldrln
 and dleldrln already  discussed  In these
  Conclusions, they are uses for which  no evi-
 dence has  been adduced with respect to the'
 benefits  to be derived  from, or the need
  for. continued, use  of these Insecticides. It
  Is patent,  therefore, that there  exists  no
  basis to Judge such benefits -and that.  In
  the context of  these  proceedings, no  eco-
 nomic, social or environmental benefit  re-
 sults from the continued use of these pesti-
  cides for such purposes.
   XI. Shell Chemical  Company, In  Its  ob-
  jections, alleges  certain'procedural  defects
  or Irregularities In the Issuance of the No-
  tice of Intention to Suspend by the Admin-
  istrator August 2. 1974. which set In  motion
  the  Institution  of  these  consolidated  sus-
 pension proceedings. First, it contends that
 such  notice reversed  a  previous decisions
  by  a -former  Administrator  that   aldrln/
  dleldrln  was not an "Imminent hazard"  al-
  legedly on the basis of the same evidence
 before the  present Administrator.  USDA
  similarly, makes this argument.
   In his Determination  and Order  of De-
  cember 7.  1973, In the consolidated  aldrtn/
  dleldrln  cancellation proceedings the prior
 Administrator, in deciding not to suspend
 such insecticides stated. In part,  that  "the •
 present evidence, confined to one strain of
 mouse' Is tentative evidence of a  'risk,' but
 not sufficient proof that  aldrln/dielorta is
 a carcinogen in "human beings. If unrebut-
 ted, this evidence would be A caution sig-
 nal as to long-term erposuv*, but does not
  amount  to  a red  light  requiring  imme-
  diate elimination of aU dleldrln residue in
   "There-  are   no  registered  alternative
 chemicals for use on cranberries. But, very
 fiw, if any,  growers should critically need
 the chemical in 1976. Only 300 acres were
 treated In Massachusetts In 1972.
                                   FEDERAL REGISTER,  VOL  39, NO. 203—FRIDAY, OCTOBER 10, 1974

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                                                           59
  the  diet." The Administrator  In his Au-
  gust 1, 1974. Notice of Intention to Suspend
  stated that "an Intense examination of the
  relevant evidence  over the  past year  •  •  •
  brought to light certain previously unknown
  facts,  which have now been reviewed and
  scientifically documented for the first time."
  Such facts, clearly additional to those men-
  tioned by  the  former Administrator In his
  order of December 7,  1973 and  his order of
  March 18,  1971. In which he also failed to
  suspend the 2 Insecticides Involved, are then
  briefly set  forth In the August 2, 1971 no-
  tice of the Administrator. They  clearly form
  a new and additional  boats supporting and,
  perhaps, requiring the notice of  Intention to
  suspend. Furtner, certain factual assump-
  tions or predictions by the  former Admin-
  istrator forming the basis for his decisions
  not to suspend proved to be untrue.  More-
  over,  the  Administrator could also Issue
  such a suspension on the basis  of an exten-
  sive  re-evaluation of  existing  Information
  "•which perhaps brought  its full  Impact to
.  the attention  of  the  experts for the ant
  time." "Bell v.  Goddard. supra." at p.'  181.
   Shell Chemical .Company further contends
  that the Notice of Intention to  Suspend "Is
  fatally defective In that, on  information and
  belief,  It was based on Improper ex  parts
  communications with  the Office of the Ad-
  ministrator by parties In the  cancellation
  proceeding and/or their  representatives  or
  agents  and/or Congressmen  and  Senators
  and  their  staffs."" These allegations  have
  not been established. In any event, they are
  bottomed upon Shell's contention that the
  suspension proceedings are  but a phase or
  port of.the cancellation  proceedings. Such
  la not the case. We agreed that the August 2,
  1974 notice was based In large part upon evi-
  dence  adduced In the cancellation hearing.
  This does not alter our conclusions. It would
  be nonsensical  to suggest that the Adminis-
  trator  could  not  consider such  evidence In
  making his determination to suspend or that
  he need hold. In effect, a public hearing on
  question of whether a suspension proceed-
  ing should be Instituted which  would  In
.  turn require a public  hearing,  which Shell
  appears to contend herein.
   The Administrator, In the Issuance of the
  August 2, 1974 notice, was functioning In an
  accusatory  capacity in  Instituting or initiat-
  ing an action with the further responsibility
  of  ultimately determining the merits of the
  "charges"  so presented.  While what was
  formerly known as the  Administrative Proce-
  dure Act requires  the  separation of the ad-
  Judlcatory and  prosecutortal functions in an
  agency (5 U.S.C. 864
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                                                               60
                                                           NOTICES
    •ralso creates a- hazardous situation to.
     public, that should be  corrected Im-
mediately  to prevent  serious Injury, end
which cannot be permitted to continue dur-
ing cs» pendency of odmlnlscratlve proceed*
lags. AS "imminent hazard" may be de-
j'.ored at any .point In a chain  of events
vhica say ultimately result in harm to tho
.public, is la =ot necessary that the final an*
'lelpoted "Injury actually have-occurred prior
to a determination that an "Imminent haz-
'ard" rxists.
  Wo need  not spin any sophisticated. In-
tricate ratlonala or argument in this connec-
tion,, as  was dcae by respondent so well In
the  brief flier1 herein, with which we basi-
cally agree, la  short,  suspension  to  to  be-
based upon potential or likely Injury and
need not be baaed upon demonstrable Injury
or certainty of future public harm. Cf. "En-
vironmental Defense Fund v. Environmen-
tal Protection Agency." 466 P.  2d 628. 040
(D.C. Clr. 1973).
  Briefly, we are talking of a cancer hazard
to man.  We must remember. In this regard.
the characteristics of'a chemical carcinogen
such as  aldrtn/dleldrln, that Is. the  scien-
tific Inability  to determine a safe or thresh-
old level for man. the fact that the chemicals
are carcinogenic at  the lowest doses tested.
that residues  of dleldrln In laboratory spe-
cies which  developed  cancer from dleldrln
approximate those residues in the American
population, the Irreverslbillty of the carcino-
genic effect once set In motion by the chemi-
cal carcinogen and  the long latency period
during which  the disease has  actually set In
acd U developing but  Is not 'yet  manifest
Given these characteristics, the rials of Injury
or hana from the use of the pesticides Is pres-
ent during the pendency of the cancellation
proceedings even though the effects of such
'-'-try may not be manifested for many years
     line. This Is precisely what the Admln-
_  4tor had In mind In his March 18. 1971
policy statement set forth above, we believe.
tn short, the continued use-of aldrtn and
ileldrln  even during the limited period with
arnlch we are concerned presents  a signifi-
cant potential of an  unreasonable risk of
cancer In the American public.
  In this regard. Dr. Saffiottl said the follow-
ing: It Is Ukely that Dleldrln residues will
jontamlnato a large proportion of the food
tupply  of  the American people  for  many
years to come because of post usage of this
persistent pesticide. I am  clearly not advo-
cating that a large proportion of the food
supply to the American people be eliminated
because  of  its  presently unavoidable con-
tamination with Dleldrln. At the same time,
as a scientist, I am  unable to conclude that
the  continuing  contamination of the envi-
ronment and  our food  supply with Dleldrln
will not produce in  some of us the develop-
ment of cancers,  as it has indeed been re-
peatedly shown  to do  so  In other  mam-
malians.
  We fear that we have exhausted the  reader
by this time and we know we have exhausted
ourselves In Uiulag this decision within the
Impossible time constraints Imposed by the
statute and the rules of practice. We merely
further  say that the registrations of  aldrin
and dleldrln properly Involved herein should
be suspended In order "to prevent an- Immi-
nent hazard  during the time required for
cancellation" when "talcing Into account the
economic,  social, and  environmental  costs
and benefits of the use of" these  pesticides
by reason of  all that has  been already said
In this  Decision. To  hold otherwise  la to
 demand a state of knowledge with respect tc
cancer which we do not possess.
   Nor does the recent decision in "Reserve
V'nlng  v. United States." No. 74-1291 (6th
     June 4, 1074) alter this conclusion as It
     ostlngulshable from the  case at hand.
 While there are several grounds of distinc-
 tion, such as the relative absence of asbestos
 in tho population of Duluth. Minnesota, os
 compared with the almost universal presence
 of dleldrln In humans at significant levels.
 and the possible difference between an "un-
 reasonable risk to man" and "demonstrable
 health hazard," the major  distinction, we
 believe, which'was recognized by the Court
 In Reserve Mining, Is the question of burden
 of proof. In  that cast, the Court stated that
 "Plaintiffs have failed  to  prove that  a de-
 monstrable health hazard exists. This failure.
• we hasten to  add, is not reflective of any
 weakness which It Is within their power to
 cure, but rather, given the current state of
 medical and scientific knowledge. Plaintiffs'
 case la based only on medical hypothesis and
 Is simply beyond proof." The Court there was
 not dealing with a substance Intended  to be
 utilized as a poison. Under  the Federal In-
 secticide. Fungicide, and Rodentlclde Act. as
 amended, the  Congress, on the  contrary.
 properly  placed the  continuous burden of
 proof of safety on the registrant."
   Order.  The registrations Issued under the
 Federal Insecticide. Fungicide, and Rodentt-
 tide Act. as amended, of the pesticides aldrin
 and dleldrln Involved In these consolidated.
 suspension  proceedings  are  hereby  sus-
 pended."
                   Hnaxar L, PEBUUIT.
          Chief Mmtnlitrattce lam Judge.

   SUTZMBSB 20.1974.

       [FXF.RA. Dockets Nos. 145 etc.]
      Susu. CHTMtCAi. COMPACT, rr At.

 cpnnoti  or THE  ADMBRSTBATOB,  Ttrraan-
   MSTTAS. raoTEcrxoy AOENCT, ott TUB SUS-
   PENSION OF ALDSO-DZZUaXH

   On August 2.1974. the Environmental Pro-
 tection Agency  (EPA) Issued a notice of in-
 tent  to suspend the registrations and pro-
 hibit the production for use of all pesticide
 products containing Aldrin. or Dleldrln.  com-
 pounds manufactured   exclusively  by the
 Shell Chemical Company (Shell). This notice.
 pursuant to section 8(c) of  the Federal In-
 secticide,  Fungicide  and  Rodenttclde Act
 (FIFAA).> resulted In  several  weeks of ex-
 pedited hearings before Chief Administrative
 Law Judge Herbert L. Perlman, the presiding
 judge at the on-going  Aldrtn-Dleldrin can-
 cellation hearing which began In August of
 1973.» On September 23. 1974. he- transmitted
 to me his recommended decision. Including'
 findings of fact and conclusions,  which is
 attached to this decision,
   **We do  not agree that this burden was
 not continued In the  1973 amendments 'to
 the act or Is  altered tn a suspension pro-
 ceeding,  as contended by Shell  Chemical
 Company. Mention  should also be made of
 United States  v. Swing Bros. Co.. Inc.. No.
 73-1008 (7th Clr.  August 28. 1974)  where
 the Court found  that DDT and dleldrln
 found In processed  fish at levels above FDA
 actionable limits were "food additives" under
•the Federal Food. Drug and Cosmetic Act.
 We are uncertain of the significance of this
 case to the Issue at hand.
   a In order to avoid any ambiguity we have
 not made  any distinction with respect to
 registrations of aldrin  and dleldrln held by
 registrants In these proceedings which we be-.
 Hove may have already been  suspended by
 operation of law. that is. resulting from the
 untimely filing of objections.  (See footnote
 3.)
   'The Federal  Insecticide. Fungicide  and
 Rodentlclde Act (FIPRA). 7  U.S.C. 135 et
 seq., as amended by Pub. L. 92-516, 86 Stat,
 973. October 21.1972. The regulatory author'
 Ity under FIFRA was  transferred  from tht
 Department of Agriculture to EPA  by Re-
 organization Order No.  3,1970.
   A. Characteristics and Utes of Aldrtn-ZHat-
• drin.* Aldrin Is the common name of a chem-
 ical compound containing not less than 95
 percent of  1.8.0.10ai.ll-hexachlorc-i3-7. 6-
 endo - 2.7.8 - exo - tetrocyclo   |8Ja.l".0'-7]
 dodec-45-dlene; It has been used as a con-
 tact and stomach insecticide on a wide variety
 of crops in diverse locations and situations
 since Its Introduction In the United States In .
 1948. As a pure compound, it ss an odorless,
 white, crystalline solid; technical compounds
 can be various shades of brown;  It Is llpo-
 phlllo. meaning that  It h«a &Q affinity for
 fatty body  tissue, and is fat soluble. It de-
 grades or metabolizes Into Dleldrln.
   Dleldrln. a closely  related  manufactured
 product as well as a  metabolic degradation
 product of Aldrin,  is the common  name
 for a mfttftrtiU  containing not loss than 8S
 percent    of   1.8.9.10.11.n-hexachloro-4.8-
 exo - epo>y-2.3-7,6-endo-2.1-7.8-exo-tetracylo
 [6.2.1.1.".0"1  dodee-9-ene. The pure com-
 pound is also on  odorless, white, crystalline
 solid with  a  somewhat heavier  molecular
 weight than Aldrin. It also Is persistent, Is
 more stable and  toxlo than AHrtn,  and is
 llpophulo.
   Aldrin and Dleldrln both are acutely tozle
 to humans. Poisoning may occur by Ingestlon,
 inhalation,  or skin absorption, and  serloud
 symptoms may result from the ingestlon of
 as little as one gram (1/28 of an ounce).
 Symptoms of acute exposures Include renal
 damage, ataxla, tremors, convulsions followed
 by central  nervous system depression, res-
• plratory failure and death. Chronic exposures
 may result In damage to the Uver and other
 body organs.
   During the earlier yean of Its use In the
 United States. Aldrin was almost entirely lim-
 ited to applications on cotton, but  In the
 mld-lflSO's  it was replaced by Dleldrln. By
 1963. cotton constituted less than one per-
 cent of total use of Aldrin. As  of. 1971. soil
 applications for corn accounted for 80 percent
 of the total Aldrin usage. Other uses Included
 termite control (14 percent), rice seed treat-
 ment (3 percent), citrus oil use (1 percent).
 and miscellaneous applications  (2 percent)-.
 Production of Aldrin In the first six months
 of 1974 was 9.7 million pounds, compared to
 approximately 8.7 million pounds produced
 for the same period In 1973. •       ' •
   Dleldrln. because It is more persistent, re- •
 placed Aldrin on 'cotton until the boll weevil
 became resistant  to both these chlorinated
 Insecticides la the late 1950's and early 1960X
 Dleldrln also was used on house files and
 mosqultos. until they too became resistant,
 and on a variety of other Insect pests. The use
 of Dleldrln has declined from a ni«»m»nm of
 about 3.8 minion  pounds In 1956 to approxi-
 mately 0.8  million pounds today. The most
   'The transcript of the cancellation hear-
 ing already exceeds 24,000 pages, not Includ-
 ing many thousands of pages of the witnesses'
 statements (which ere reported-separately)
 and exhibits. The suspension hearing tran-
 script approaches 4.000 pages '.n length, also
 not including the lengthy statements by the
 witnesses  and exhibits, wh^h  roughly  are
 the same length, as the transcripts, plus more
 than one thousand pages of briefs, by  the.
 parties. •
   ' These two similar compounds have some-
 what different uses; but because In the en-
 vironment or in the body Aldrin quickly de-
 grades to the more stable Dleldrln form, the
 two terms win generally be used Interchange-
 ably In this opinion.
                                  fEDERAl REGISTER.  VOL  39, NO. 303—FRIDAY. OCTOBER 18.  1974

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                                                              61
 recent accurate figure* for Dleldrtn Indicate
 that  In  1971 approximately 44 percent was
 used  tor termites, 20 percent on fruit foaage,
 14 percent for seed treatment. 13 percent on
 vegetables, and 9  percent for miscellaneous
 uses,0ncludlng tobacco and sweet potatoes.
  Combined  Aldr*"  and Dleldrin consump-
 tion,  which In  1970 was 10.7 million pounds,
 rose In 1971  to 12.3  million pounds. The- es-
 timate fer 1973 is approximately 11 million
 pounds.
  B.  Definition of cancellation and suspen-
 sion.  Aa will be discussed more fully  later,
 cancellation  la warranted under the FIFRA
 when there  Is  a  "substantial question of
 safety" concerning a pesticide.  During the
 period of the administrative  review process,
 which often  lasts  several years, the manu-
 facture and distribution of the product con-
 tinues unaffected—a fact which may con-
 tribute to the  protracted nature of many
 cancellation proceedings.4
  Suspension Is mandated when there  Is an
 "Imminent hazard** to *«**» or the environ-
 ment. This may be declared at any stage of
 the  administrative  review process,  either
 upon receipt of new evidence or after re-
 evaluation of  existing evidence.* The sus-
 pension  order,  which resembles  a  prelimi-
 nary  Injunction,* Immediately halts  the pro-
 duction and distribution of the pesticide and
 remains In effect until the cancellation hear-
 ing Is completed and a final decision is made
 by the Administrator of EPA.
  0. History  of the cue. For almost four
 years, EPA has had under consideration the
 issue  of  Aldrln-Dleldrin. On December 3,
 1970.  one day after the Agency formally came
 into existence.  It  received a petition  from
 the Environmental Defense Fund (EOF) re-
 questing  the cancellation and  Immediate
 suspension of all uses of Aldrln-Dleldrlru As
 a result, on March 18, 1971. the Administra-
 tor of EPA issued a notice of cancellation
 based upon a finding of a "substantial ques-
 tion as to the safety" of Aldrm and Dleldrin.'
 The Administrator also concluded, however.
 that the evidence then available to  him did
 not demonstrate "an i™min«ti* hazard to the
 public".  He,  therefore, declined to  order a
 suspension of the compounds pending  com-
 pletion of administrative review.
  EDF  promptly  filed  a  petition  In the
 United States Court of Appeals for the Dis-
 trict of 'Columbia to review the Administra-
 tor's  failure  to suspend' the 'registrations.
  • The Administrative Law Judge noted on
several occasions during the suspension hear-
ing  that the  cancellation proceeding  on
Aldrln-Dleldrin was characterized  by a fair
amount of .footdragglng. See, e.g.. Transcript
306.
  •See Bell r. Ooddard,  386  P.  3d 177, 181
(7th Clr. I960), where an administrative ac-
tion was based on reanalysls "which perhaps
brought  its  full  impact to the attention of
the experts for the first time."
  • Environmental Defense Fund  v. Environ-
mental Protection Agency, 456 P. 3d 538, 538
(C-AJ3.C. 1072)  (hereafter EDPv. EPA).
  Not* that In Nor-Am  Agricultural Prod-
ucts. Inc. v. Hardln 436 F.  2d 1151 (7th Clr.
1970).  cert, denied 402 U.S. 935  (1971), the
court held that a suspension order, since it
was not a final Agency decision, was not judi-
cially revlewable under FIFRA or  the Admin-
istrative Procedure Act. The Nor-Am de-
cision  was .criticized  in  dicta in Environ-
mental Defense Fund v. Ruckelshaus. 439
F. 2d 5«4. 691-682. (C-AJJ.C. 1971) [hereafter
EDF v. Ruckelahaus).
  i Statement of the Reasons Underlying the
Decision on Cancellation and Suspension of
DDT,  2,4,5,-T,  and  Aldrtn  and  Dleldrtn.
March  18, 1971.
                 NOTICES

The Court's decision, issued on May 8, 1972.*
remanded the record to EPA for further con-
sideration of the Issue of suspension. In light
of the judicial Interpretation of the power of
suspension enunciated  In  the decision and
the  March  28.  1972  report  of the Aldrtn-
Dleldrln Scientific Advisory Committee. The
Court specifically directed EPA to examine
the nature and  extent of evidence available
on the careinogenlclty of Aldrin-Dleldrln.
  Following a review of the scientific evi-
dence requested by the Court, the Adminis-
trator reaffirmed the notices of cancellation
of nearly all Aldrin-Dleldrln uses on June 26.
1972.* The order also solicited public  views
as to whether any of the cancelled uses also
should be suspended, with particular refer-
ence  to those methods of  application and
formulation  presenting  the  most obvious
risk of widespread, unavoidable dissemina-
tion of the compounds.
  Five months later, on December 7, 1972,
the Administrator announced that the regis-
trants of  Aldrin-Dleldrln had agreed volun-
tarily to eliminate several of the more con-
troversial  uses of the product. Furthermore,
pursuant to the May 6,1972 Court of Appeals
order, the Administrator announced that he
had further examined the Issue of suspen-
sion and determined that the available evi-
dence still did not justify a finding of Im-
minent hazard*              *
  The cancellation hearing on the risks and
benefits of Aldrln-Dleldrin  began on  Au-
gust 7, 1973 and was still in progress a year
later  when, on August  2. 1974, the Agency
Issued Its  notice of Intention to suspend. On
August 7.  1974. a presiding officer, Chief Ad-
ministrative Law Judge Herbert L. Perlman,
was  appointed for the  suspension hearing,
which commenced on August  14,  1974 and
was to last no longer than 16 hearing days.
The hearing closed on  September  12, 1974.
the recommended findings and conclusions
of Administrative Law Judge Perlman were
delivered to me on September 23.  1974. and
on September 24, the parties submitted ex-
ceptions to Judge  Perlman's recommended
decision,
  D. latuca and  controversies. The cancella-
tion hearing, which is expected to continue
for  an indefinite period,  has dealt with a
broad range of questions concerning Aldrln-
Dleldrln's  alleged deleterious effects on the
environment and on human beings." in con-
trast, the  suspension hearing has been con-
cerned solely with whether  Aldrin-Dleldrln
  • EDP V. EPA. 466 F. 2d 528 (CAJJ.C. 1972).
  • The Administrator exempted those regis-
tered uses Involving subsurface ground In-
sertions  for  termite  control,  mothproofing
processes using a closed system, and the dip-
ping of roots or tops of nonfood plants.
 . a Testimony  on  environmental  (non-hu-
man health) effects of Aldrin-Dleldrln has
been presented in the cancellation hearing
relating  to Dleldrln residues in marine and
freshwater aquatic organisms, birds, land
tmmmnln. and  soil invertebrates. Because of
its persistence  and ubiquitous presence ln>
nature.  It  Is  regarded  as a particularly
troublesome potential threat to the environ-
ment. Considerable testimony  has been pro-
vided relating to Its  acute  and chronic tox-
Iclty, transport mechanisms,  bloaceumula-
tlon. and  blomagnlflcation characteristics.
resistance of  certain species, and various ef-
fects  on  the respiratory  and reproductive
mechanisms of  fish and terrestrial life. Theso
environmental  factors, as well  as  other
human health hazards, although  not the
subject of this suspension  proceeding, will
b« carefully considered In  the final Agency
decision on cancellation.
 poses a cancer hazard to human beings, and
 whether It provides countervailing benefits.
   During the hearing, counsel for both EPA
 and Shell characterized the Issues as "cancer
 and corn." although Judge Perlman correctly
 pointed out that the benefits also Included a
 number  of other crop uses." Nevertheless.
 In the suspension hearing record, statements
 of the parties indicate that the major con-
 troversy, in fact, may be narrower than "can-
 cer and com." Counsel for Shell declared at
 the beginning of the bearing: "Tour Honor,
 In our  view the Issue Is really  cancer."u
 Even the  presiding. officer,  who  properly
 sought to Insure that all relevant Issues were
 addressed, stated explicitly, "I mean there Is
 no fooling around, the major Issue Is can-
 cer." a
   E. Legal  background. The  Administrator
 la authorized by  section 8(c) (1) of FIFRA "
 to suspend Immediately the registration  of
 a pesticide pending the outcome of final can-
 cellation proceedings if he  determines such
 action Is necessary to  prevent an Imminent
 hazard."
   •  • • the function of the suspension de-
 cision la to make a preliminary assessment
 of evidence and  probabilities, not an .ulti-
 mate resolution of difficult Issues.11
 and
   The suspension order thus operates  to af-
 ford Interim relief during  the course of the
 lengthy administrative proceedings.11
   In accordance with the proposition that a
 suspension order  Is not a final  determination
 on the merits of cancellation, but rather  a
 temporary decision, the Agency has  token
 the  position that it has a continuing re-
 sponsibility to review  suspension  decisions.
 In his order of March 18.  1971."1 then-Ad-


   n counsel  for  Shell Chemical  Company
 stated, for. example, that "corn, that Is really
 all we care about." Transcript.  87. See also
 Transcript 123,294.
   a Transcript 87.
   i» Transcript 92.
   "7U.3.C. 136d(c)l.
  u The Department of Agriculture has eon-
 tended from the beginning of the suspension
 hearing that there  has been an  unlawful
 commingling of  "prosecutlve, adjudlcatlve,
 and  judicial functions required to be per-
 formed  under FTFRA." (See Transcript,  p.
 37.)  This Is an Interesting  assertion because
 prior to  1970 the functions of  FIFRA, In-
 cluding suspension,  were performed by the
 Secretary  of  Agriculture  Section  6(c) of
 FIFRA clearly states that the Administrator
 shall Issue the notice  of Intent to suspend
 and, later, make  'the suspension decision.
  Shell also has repeatedly alleged that un-
 lawful ex parts consultations gave rise to the
 2  August  1974 Notice  of Intention to  Sus-
 pend. I am completely convinced that any
 and  all consultations  between  me and my
 staff which led to the decision to initiate
 the  suspension  proceeding  were entirely
 proper and In accordance with  due process
 requirements, administrative law and  prac-
 tice,  and fundamental notions  of fair play
 la the conduct of Agency adjudicator? pro-
 ceedings and therefore find the assertions of
 USDA and Shell  to be unfounded.
  The function of a suspension order  Is not
 to reach a definitive decision on the registra-
 tion  of a pesticide, but to  grant temporary,
 interim relief. The Circuit Court of Appeals
 for the District of Columbia twice has stated
 this view:
  a EDF v. EPA, 465 Fid at 537.
  "EDP v. Ruekelshaus, 436 F.2d at 589.
  " 18 March 1971 Order:  Reasons Underly-
 ing  the  Registration  Decisions Including
Products Containing DDT, 2,4,5-T, Aldrtn
 and Dleldrtn, p. 12.
                                 FEDERAL REGISTER, VOL 39, NO.  203—FRIDAY,  OCTOBER  18. 1974

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      ..trator William D. RuckeUhaua  stated
  that the Agency would be prepared to reeval-
  uate the question of suspension at any later
  stage In the administrative proceedings. In
  Its most recent suspension  order. In  this
  proceeding, the Agency stated "The Admlnls-
  ; -stive process Is a continuing one. and colls
  for continuing re-examination at significant
  Junctures." '•
    The Administrator,  as noted  above,  mar
 . suspend when he finds that an "Imminent
  hazard" would result during the  pendency of
  cancellation  proceedings.  Section  2(1) of
  FIFRA » d*caes  the term "Imminent hazard"
  as "a situation  which  exists  when the con-
  tinued  us« c  a pesticide  during the time
  required for cancellation proceedings  would
  be likely to result In  unreasonable adverse
  effects on the environment." "Unreasonable
  adverse effect on the environment" Is defined
  by section 2(bb) of FIFRA " as "any unrea-
  sonable risk to man or the environment, talc-
  ing Into account the economic, social,  and
  environmental coats and benefits of the use
  of any pesticide."
    The Circuit Court of Appeals for the Dis-
  trict of Columbia has amplified the statutory
  definition  of  imminent hazard:  "But  we
  must caution  against  any  approach to the
  term •imminent hazard,' used In  the statute,
  that restricts it to a concept of crises." a
   In another case, the Court declared: The
  [Secretary of Agriculture) has concluded that
 the most Important element of an "Imminent
 hazard to the  public" is a serious threat to
 public  health, that a  hazard may bo  im-
 minent even If its Impact will not be appar-
 ent for many years and that the  public pro-
 tected by the suspension provision Includes
 fish and wildlife.  The Interpretations all seem
      Uent with the statutory language and
      se.=>
      Addition, the Administrator,  In his order
 01  March 18. 1971 specifying the  criteria for
 determining an  "imminent hazard," stated
 explicitly that suspension was warranted to'
 prevent actions "which cannot be permitted
 to continue during the pcndence of adminis-
 trative  proceedings. Imminent hazard  may
 be declared at any point In the- chain  of
 events which may ultimately result In  harm
 to the public." =«
  In a suspension proceeding, unlike a can-
 cellation action. EPA Is not required to bal-
 ance  possible  benefits  against the environ-
 mental  and health risks of pesticide usage.
 The Court of Appeals has considered this ex-
 ercise of  administrative discretion by EPA
 and concluded: "We do not say there  Is an
 absolute need for analysis of benefits." =
  We are not clear that the FIPRA requires
 separate analysis  of benefits at the suspen-
 sion stage. We ore clear  that the statute em-
 powers the Administrator to take  account of
 benefits  or  their  absence as  affecting  1m-
 mlnency of hazard.?*
  The Agency  traditionally has  considered
 benefits as well as risks, however, and in my
 opinion,  should  continue   to  do  so.  The
recommended decision of the Administrative
                       62

                  NOTICES

  Law Judge contains a lengthy discussion of
  the crop uses of Aldrin-Dleldrin. with their
  effects and alternatives. Benefits and alterna-
  tives  are discussed  In  Part HI of  this
  opinion."
    In deciding to suspend because of  a sub-
  stantial risk, of cancer In man. the Admin-
  istrator Is obliged  to follow expressed Con-
  gressional policy  of  keeping carcinogenic
  chemicals out of the food supply. One Court
  haa pointed  out that although pesticides are
  not  "food  additives"  under  the Delaney
  Amendment, 31 U.3.C. 348(c) (3) (A),  the
  Amendment does however, indicate the mag-
  nitude of Congressional concern about the
  hazards created  by carcinogenic chemicals,
  and places a heavy burden on any adminis-
  trative officer to explain the basis for his deci-
  sion to permit the continued use of a chemi-
  cal known to produce cancer In experimental
  animals.2*
    The Seventh Circuit has recently held that
  pesticide residues  In processed foods were-
  "food additives" within the meaning of other
  sections of the Food. Drug and Cosmetic Act,
  21 O.3.C.  321(s).» But. since the Delaney
  Amendment  does prohibit the  setting of sofa
  levels/tolerances  of carcinogenic food addi-
  tives, and since Aldrln-Dleldrln U present as.
  residue in processed foods, the Administrator
  has  a particular burden to explain a, basis
  for a decision permitting continued use of a
  chemical known to be a carcinogenic In lab-
  oratory animals.

  H. THE  ISSUE OF THE CASCTKOCZHICTrr Or
  " Order of August 2. 1974, at p. 4, quoting
from EDP v. EPA. 465 F.2d 828 (1972).
  =>7US.C. 136(1).
  ='7U.S.C. 136 (bb».
  "ED? v. EPA. 465 F. 2d at 5-10.
  a EDr" v. Ruckelshaus. 439 F. 3d at 597.
  « Ord-r of ia March  1971. supra, p. 6.
  51 EDc1 r. EPA. -165 F.  2d at 540.
  * EOF v. EPA. 465 P. 2d at 538. If an analysis
of'benefits Is  undertaken,  the  Courts have
!>•—'rte-J that "greater .weight should be ac-
     \  line value  of a pesticide  for the con-
      r  disease, and less weight should  be
    .ded Its value for protection of a com-
mercial  crop." EOF v. Ruckelshaus,  439 F.  2d
at 594.
   A.  General  theories of  carcinogenicity.
 Ussplte tha manpower and resources which
 have  been devoted over several decades to
 the study of cancer,  scientists are stm for
 from  agreement on the causes, nature, and
 even definition of cancer. In such aa Inquiry,
 where we  are  acting on the  frontiers  of
 knowledge," we must  rely on the best avail-
 able  evidence and interpretations and  be
 prepared to modify our views if future scien-
 tific advances show we were in error.
   A carcinogenic substance, in our opinion.
 la one  which  Increases the  incidence  of
 benign or malignant tumors In exposed anl-
• mals,  decreases the latency period between
 exposure and onset of the tumor, or results
 In unusual tumors."
   The once-significant distinction between
 tumors and cancers, or between tumorogenlc
 and carcinogenic substances, has lost much
 of Its validity with the Increasing evidence
 that many tumors can develop into cancers.
 Thus, for purposes of carclnogenlclty testing,
 they  should be  considered  synonymous.51

   "It is, nevertheless, clear from  the  EPA
 Rules  of Practice 40 CJ.R. J 164.121 (g). and
 from'the case law, that the burden of proof
 In establishing the safety of a pesticide prod-
 uct in both cancellation and suspension pro-
 ceedings  remains  at  all  times  with  the
 registrant. EOF v. EPA.-465 F.2d 528. 532 (D.C.
 Cir. 1872);  Neodane Company. Inc. v.  En-
 vironmental  Protection Agency, 470 F.2d 194
 (8th Cir. 1972);  Stearns Electric Paste Co. 7.
 Environmental Protection Agency,  439 F.2d
 584. 593. n. 34 (C.A.D.C. 1971). See  also  Ad-
 ministrator's Order of 18 March 1971.
   » EOF v. Ruckeishaus. 439 F.2d at 596, note

   ''United States v. Vita Food Products of
 Illinois. Inc.. No. 73-1008 (7th Cir. 28 August
 1974).
   a Industrial Union Department.  AFL-CIO
v. Hodgson. 499 FJ2d 467. 474 (CJUD.C. 1974).
   31 The  International  Association  for  Ra-
seorch on Cancer (IARC) defines cancer a
the Induction or enhancement of a neoplasm.
International Association for Research on
Cancer Report, p. 9.
   *> IARC Report, p. 10.
  Similarly, the distinction between benign and
  malignant tumors,  while Important  to  the
  Individual host animal. Is not a rellablo In-
  dicator of carclnogenlclty. for "In the think-
  ing of moat experimentalists, the Induction
  of a benign tumor Is merely n stage la a sub-
  sequent occurrence of a malignancy." "

    This does not mean that some cate-
  gorization  Is  not useful  to  researchers.
  One recognized authority has set forth
  five stages of cancer development: (l)  No
  hyperplastlc lesions,  (2) hyperplasla, (3)
  hyperplastlc  nodules,  (4)  small carci-
  noma (less than 5 mm), (5) large car-
  cinoma." If,  for  example, a pathology
  study found stage-four carcinoma In the
  exposed animals and the same number
  of stage-two lesions  In the controls, the
  results would be  distorted If the re-
  searcher thereby concluded that the sus-
  pected carcinogen had no effect. Such
  differentiation is  not  critical to this
  opinion, however, except possibly In the
  later analysis of  certain Aldxln-Dleldrln
  tests on rats.
    We have long known that cancer may
 be induced by chemicals,  radiation, and
 even variations In the  environment, but
 we are still not  certain of  the  various
 mechanisms   Involved.  Although  four
 basic models have been proposed," we do'
 not have a unified model  explaining the
 relationship between the dose and the
 subsequent cancerous'response.
   These theoretical concepts have a bear-
 Ing  on the Aldrin-Dleldrln  issue, par-
 ticularly as to the Question of the exist-
 ence, OP non-existence, of a threshold
 level of carcinogenic effect: A "no-effect"
 level theoretically may exist, but It has
 not   been  conclusively   demonstrated.
 and—based on the record In this case—
 we certainly do not know the "no-effect"
 level for Aldrin-Dieldrln. The lowest dose
 tested (0.1  ppm)  still produced signifi-
 cant  tumors In experimental animals."
 I therefore agree  with the finding of the '
 Administrative Law Judge that "It is Im-
 possible to establish a 'safe' level of ex-
 posure of Aldrin-Dieldrln to man." *

   " World  Health Organization  Reports  of
 Cancer, EPA Ex. 40B.
   "Statement of Melvln D.  Reuber.  MJ3
 EPA Ex. 42, p. 10.
   = These models are the following: (1) Tho
 "one-hit" theory, derived  from extensive re-
 search on atomic radiation, which holds that
 a carcinogenic effect may result from a single
 infortultous "hit" on a single cell  by some-
 form of energy,  such  as a  chemical. (2) The
 so-called loglt model, derived from chemlcM
 kinetics, that there Is a slow Increase In re-
 sponse as the dose Increases until anally the
 effect levels off when the limited number of
 chemical bonding sites are occupied. (3) Tho
 so-called theory  of metabolic overload, which
 assumes that there Is a threshold level In each
 Individual, and  only when that Is exceeded
 will cancer  develop.  (4)  Tho theory that
 everyone has a  dldereut sensitivity to car-
 cinogenic stimuli, and  that as a statistical
 assumption the  distribution takes the  form
 of a bell-shaped curve.  It  may well be that
 more  than one theory Is correct, depending
 on  many variables,  but that Is  beyond tlia
 scope of this opinion. In any cose, these four
 i..odels produce  very  similar  results wltliln
 the 2-98 percent range.
  " Shell Ex. S-3A. Tables Id & 17.
  ** Recommended Decision nnd Findings of
Fact and Law. Finding No. 25, p. 26.
                                 FEDERAL RgGISTcll. VQL 37, NO. 203—FRIDAY, OCTO3ER 18.  1974

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                                                              63
                                                            NOTICES
   Contrary to a wide-spread belief. It la not
 true, that all substances are carcinogenic tf
 introduced In sufficiently large <*.«•**, Cor*
 clnogenletty la a relatively rare phenomenon
 exhibited by only a few of the many hun-
 dreds of thousand! of chemicals.** Trig** QQ*^
 are administered In »n«m*i testa, not because
 the researchen seek to  correlate "»'«"»'  re-
 sponse levela to humans, but because with a
 limited number of animals this methodology
 Is necessary to determine groan effects.* Con-
 sequently,  a  substance that  will  Induce
 cancer In experimental »i compounds.
 WhUe dogs have been employed for tests of
 cardnogenlcity, with noteworthy  success m
 selected  eases  (bladder cardnogenlcity  of
 aromatic amines), the requirement of life-
 time feeding makes this species too expen-
 sive,  in terms of time and funds, to be em-
 ployed routinely. EPA Ex. 40P.
   <• Although during the tn-m-ing shen argued
 that  mice were  an Inappropriate test species,
 one of the reasons for the relative, shortage of
 Shell data on other species is that Shell pre-
• f erred to use mice in its own cancer experi-
 ments.
   « Shea Ex. 12. pp. 30-33.
   M in tny ease, three of the four remaining
 mice strains were  especially  resistant  to
 spontaneous llvar lesions (these  were the.
 strains used by Bhell) and  the fourth had
 only average susceptibility. This will be dis-
   used in more  detafl In the  next section.
   •EPAEx.46,p.  ll.
pertinents are designed to compare the effects
of one variable—the chemical—on exposed
animals otherwise subject to the same con-
ditions.*
  Some  witnesses also suggested that car-
cinogens can be species-specific—that is, a
chemical substance might affect mice  but
not any other species, including "itm This is
theoretically possible. But of the thousands
of compounds tested, the  record  Indicates
that this effect has been suggested for only
one of them.'1 and even this single exception
has been seriously challenged.** I  therefore
  If carcinogens  are  not species-specific. It
logically folliws  that the  demonstration of
carcinogenic effect In more  than one species
Is not absolutely necessary for a amting of
carclnogenlclty.*
  Most  carcinogens  are also not organ-
specific.  In a survey  by Dr. Tomatis  of M
compounds known to produce liver tumors
in mice, 40 also induced tumors in  a variety
of other organs.0 Furthermore, chemically-
Induced tumors in one species need not ap-
pear In the same organ In another species.0
Thus,  a  carcinogen which  Induces  liver tu-
mors  in mice might, for example, produce
mammary cancers in rats  and lung tumors
in men.
  a Careinogenlcity  of aldrtn-dielirtn  in
mice. There- is no dispute that Aldrtn-Dleldrln
significantly Increases the Incidence of liver
tumors In five different strains of mice-. There
Is overwhelming  scientific  data supporting
this fact, and the registrants have now con-
ceded  this point: The main result  from the
Initial analysis wes that in all Studies there
was a highly significant dose related Increase
In the liver tumors.**
  The IARC has  concluded that:  Dteldrtn
was tested by the oral route only in  mice and
rats. The hepatocarctnogenldty of Dleldrtn
In the mouse  was demonstrated  and  con-
firmed In several »H«««HMH»~*^  «m< some of
the liver faimom  were found to metastoslze.
A dose-response effect has been demonstrated
in both sexes with an Increased i™»-M«m^ in
toe females at the lowest dose tested, 0.1
ppm in the diet.**
  * EPA Ex. 8-11.
  0 The exception, according to Shell, is Pne-
nobarbitone, which is supposedly carcino-
genic In mice, but not in man. Shell Ex. 14,
based on Dr. Qemmesen's study of epileptics.
Arsenic may have  the obverse effect, but the
mice tests are still not conclusive. See Perl-
man. Becommended Decision, p. 41.
  * Dr. Schneidennon has been quite critical
of the Clemmesen study and **>"*^ndn that a
mathematical re-analysis of his  results  is
•consistent with the possibility that the antl-
convulsanta which the epileptics received in-
creased the risk of liver cancer, perhaps two
or three fold." EPA Ex. 10, p. 9.
will  rely on the conclusion of such organiza-
tions as  the International Association for
Research  on Cancer,  which have rejected
species-specificity as unsubstantiated.*
  •EPA Ex. 40-H. Even if apedes-spedflclty
does exist, it t»SIieUEx.8-3A.p.3.
  • EPA Ex. 8-17, ppJO-M.
  Shell's own test results confirm the above
conclusions.  In exposed  groups, all three
strains of mice In the seven testa had a high
Increase In the Incidence of liver tumors. The
first two tests (Study 1 and Study 2.1) are
the most meaningful because the test popu-
lations were  much larger than In the other
tests and the dose levels ranged low enough
so that acutely toxic effects did not Interfere
with the development of slower tumors. The
mice tested were also  from inbred, outbred,
and hybrid strains.10
  The  teat results show that the Increaiie 111
the Incidence of tumors  was dose-related/-*
although at doses above 10 ppm this relation-
ship was diminished because of Interference
by acutely toxic effects. At the' lowest dose
level tested, 0.1  ppm. there was on Increase
In benign and  i~ii;pnt«t  tumors." Those
that did develop had a greater tendency to
spread to other sites in the body and espe-
cially to the lungs."
  Aldrtn-Dleldrln shortened the lateucy pe-
riod In the development of tumors In  both
sexes.** In one test measuring the effects of
limited exposure,  the compound Increased
the  Incidence of tumors  after exposures aa
short as two weeks; the effects were  even
more  pronounced  after one  mouth  of
exposure.'
  The  Incidence of  malignant liver lumors
was  statistically significant In almost every
test Shell performed.*1 This elevated incidence
of malignancy Is particularly  Important be-
cause these strains  of mice were especially
resistant to malignant uver tumors. The In-
cidence of malignancy In female controls was
almost nil and In males it woe quite low.
  Exposure to Aldrln-Dleldrln and DDT ap-
parently hassynergistlc effect on the develop-
ment of tumors. Mice fed 60 ppm DDT had
some Increased  Incidence of  tumors. How-
ever, when mice received a diet of  6  ppm
Aldrln-Dleldrln  In addition to 5O ppm DDT.
the incidence of tumors  Increased sharply:
Males  had 4 times and females 8 tunes as
many  malignant tumors as those exposed
only to DDT. Dr.  Reutoer has concluded.
  It  certainly Is clear from these observa-
tions that Dleldrtn and DDT have additive
effects   when.  It comes  to cardnogenlcity.
Further, the evidence Indicates that Dleldrin
is primarily  responsible for this Important
effect.  Using  the SO ppm  group as the  con-
trols the carcinogenic effect of the combined
  "Study 1's population was over 1000 with
dose levels of J. 1. and 10 ppm. Study 3.1
had a population of 400 and five dose levels
of 125, 2A B.O, 10 and 20 ppm. Note that
Dr. Nathan Mantel has testified that Shell's
method of analysis Is on adoption of one he
developed, and he criticizes Shell for falling
to  apply  his  method  correctly.  He  states
that their analysis is  insensitive to patterns
and consistencies and the effects of compet-
ing taridty at high dose levels.  Because of
Its  shortcomings. Dr. Mantel feels  Shell's
analysis la "almost guaranteed to give non-
(Ugnlflrannn for even  the strongest carcino-
gen". EPA Ex. 3-31. pp. 3-9.
  • SheU Ex. S-3A. Table Data 1, Table Data
3; Transcript 986.
  « Shell Ex-'S-OA, Table Data 1.
  • Shell Ex. S-3A. Table Data 1, Table Data

  •EPA Br. 80, pp. 12.13: EPA Bx. S-l. p. 9.
  • EPA BX. 43-S, Table S.
                                  fDEtAL KGISTOV VOL 39. NO. 203—R10AY. OCTOBEB 18, 1974

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     !r.5 of Dleldrtn and DDT Is very highly
 significant by statistical analysis.1"
   Tin World Health Organization has recog-
 nlzvfi that'In exposed mice  there is an In-
 creased risk that liver tumors will spread to
 the  1^333.°  Shell's test results have eon-
 limed this, for at least two  of their experi-
 ments demonstrate a statistically significant
 increase of lung tumors for both sexes. Some
 'acrease In lung tumors was observed in al-
• most all their testa. Dr. Gross has  testified
 tint the results of the first study:
   • • • leave little room for  doubt that
 Dleldrin at either 0.1  ppm or  both the 0.1
 and  I ppm Ie7»ls r*"i  elevate the Incidence
 of tumors  a*  sites other  than  the liver
 (particularly ;a  the  lung)  and  that this
 elevation is highly significant In either males
 or. females or In both sexes.**
   D. Carcinogenic effects on  rats. Bats have
 been used less frequently than mice as test
 populations.  The quality of the  tests has
 varied widely, and the  results have not been
 uniform. For those reasons the Administra-
 tive -Lav Judge concluded.
   We are hesitantly unwilling at this time to
 find  that  Dleldrln is conclusively a car-
 cinogen in the rat although there are indica-
 tions "«** tnls  is  so especially when the
 chemical Is tested at the lower dosages • • •
 we are certain, nevertheless that the findings
 In the rat  cannot be  described as negative.
 (Emphasis  In original.) «
   This caution la warranted  by the serious
 deficiencies In the available rat tests. Bow-
 ever, it Is  my conclusion, following an in-
 tensive re-«xainluatlon of the statistics and
 testimony  presented in the recent hearing.
, that ' lucre  is  a  strong probability that
 Aldrin-Oieidrln is a carcinogen la  rats-  as
 veil Of» mice.'"
   .The tvo  series  of testa conducted by the
 T   '  and  Dni$  Administration (FDA) are.
     .1 Tor determining the effects of Aldrln-
 Du..OriQ on rats.  Exposed rats had a mark-
 edly, increased Incidence of liver and other
 tumors. which was especially noteworthy be-
 cause the  tested  strains had a  low rate  of
 natural  liver tumors.
   The  raia  doubled  for rats  exposed   to
 Aldrln and Increased by one-third for  those
 exposed to Dleldrln. A no-effect level was not
 observed. The liver to body weight ratio lu-
 creswd. and  at high doses there were seri-
 ous  enlargements of  the  liver.  After six
 months, a dose-related decrease hi survival
 rates was observed. In over 90 percent of the
   01 See Shell Ex. 3-A Tables 16 and 17. For
 example, the Shell  Study 2.2 shows a slg-
 nlfte-.uit Increase with 1.321 of the controls
 and ;o.5o "  of the. exposed mice developing
 znaii^nact  tumors-  This has  a very  low
 r'.unce  probability  of  .000000048.  Almost
 turee time;* as mauy of the treated mice hod
 benign or malignant tumors as did the con-
 trols (EPA Ex.  S-l, p.  18). However.  Shell
 contends that even though the Increase In
 '.-.in? tiunors U very lilgh. this Increase  is
 incidental to the development of liver tumors
 r-ncl therefore,  they reason.  16 cannot be
 proven to be caused by Aldrtu-Dleldrin.
   •'-EPA Ex. 42. p. 20. -
   u Shell Ex. S-4. p. 20.
   '-EPA  Ex. S-9.  p. 29. Dr. Gross found
 significant Increases In lung tumors, regard-
 less of whether  liver tumors  were present,
 a:;cl a decrease In the latency period. Over
 three time as many (77.8%) expowd females
 developed lung  tumors within two weeks as
 d:d th» control  females. (EPA Ex. S-l. p. 9.)
   c Rtrcoir.ir.ended Decision, pp. 56-07.
   *Tlu>  determination  that Aldrln-Dleldrm
 Is probably  carcinogenic  in  two species  Is
 A-' -uU  but not absolutely essential, to a
 f    g. of imminent hazard, as the data on
 Hi... is su2clently  strong to  Justify a find-
 In; of carcinogenic risk.
                     64
                NOTICES

rats dying at high dose levels, lesions were
present."
   Alter reviewing the FDA tissue slides, Or.
Reuber confirmed the  Increase In tumors.
He round that at the low dose levels (13-10
ppm)  there was a  low Incidence of liver
tumors but on Increased Incidence of tumors
la other organs. At  higher doses, there was
a- higher Incidence of liver tumors. This In-
cidence of tumors more than doubled at both
low and high dose levels. WbUo no liver
tumors were  observed. In controls. 18% of
the rats at high dose levels had liver tumors."
   These results are confirmed by Shell's own
test results, which show  that almost twice
as many exposed rats had tumors and the
liver to bod; weight  ratio among female rats
.increased at low doses.*
   E. Test*  on other species. Aldrln-Dleldrln
has also been tested In species other than
the mouse or  the rat. Almost  all these tests
have been on dogs and monkeys and are not
very useful, due to  their small populations
and test durations shorter than the cancer
latency period.
   There have been  three dog experiments.
The populations  have been small, ranging
from 1 to  3 »Ti«mt»« per dose leveh with ft
duration not  exceeding two years. In spite
of these obvious test inadequacies. After two
years of exposure dogs had diffuse hyper-
plasla  of the liver  which "was  such that
over a period of several years the dogs could
have developed carcinoma of the liver." n In
commenting on the weaknesses of the dog
testa. Dr. Saffiottt has stated that an accept-
able test:
   •  •   • would require  a  duration of at
I ;ast ten years to come close  to the age at
which  tumors could begin to  be found. For
example, benzldlne. a potent carcinogen for
the urinary bladder  In man as well as dogs.
took about seven years to produce Its first
tumor  In  dogs.  The  number  of  anlmalii
needed for statistical evaluation of tumor
Incidences  In  treated and control groups la
dependent on  mathematical and. not zoolog-
ical criteria, so that there is  no reason to
accept experiments on groups  of one or two
or five dogs any more than there Is to accept
experiments In one or two or five mice. In
conclusion,  these dog studies are completely
and utterly Inadequate as carelnogenesls testa
and should be totally discarded In the con-
sideration of  the  carcinogenic response to
Dleldrln.™
  There has been  only one  monkey test.
which  had five monkeys at each of five dose.
levels,  and  six controls. The  test duration
was about six years. During that time there
was some evidence of mlcroenzyme Induction,
but  there  were no  observations made on
tumors.11   .
   Dr. Safflottt has stated that: However, as
In the  case of dog studies, the number of
animals used  and the duration of the test
for only approximately one-fourth of the ex-
pected  llfespan of  this species, make  this
study totally inadequate as a carclnogenesia
test.9
  F. Extrapolation of animal  data  to  man.
The ultimate  Issue In this suspension pro-
ceeding is  whether  Aldrln-Dleldrln  is  car-
cinogenic In «""«- Because man's response
  " EPA Ex. 33.
  * EPA Ex. 42. At low doses female rats had
an especially high Incidence of liver tumors.
At high doses the Incidence of  liver  tumors
was'not as pronounced as should be expected
because the rats died from the toxic effects
before tumors could fully develop.
  « Shell Ex. 8-13.
  » EPA EX. 42, p. 38.
  « EPA Ex. 40. D. 33.
  "Transcript, 1082.
  a EPA Ex. 40. p. 33.
the finding that a substance Is carcinogenic
In experimental  animals indicates  that it
to carcinogens Is similar to that of rodents.
poses a similar risk to man. Dr. Heston has
testified:
  Knowing this, and  knowing  the general
biological similarity of mice and other mam-
tnaiinn species, including man. we can rea-
sonably expect that in a population of human
beings exposed to  Aldrin-Dleldrln. cancer
of some kind will occur in some individuals.
and these Individuals- will not have  been
afflicted in the -absence of these compounds
• • • The human population Is so much more
genetically diverse than any laboratory ani-
mals. that if a chemical has been shown to
be carcinogenic by a significant induction In
any laboratory strain of mammal,  we  can
reasonably expect that at least certain human
beings would also respond to the chemical
by developing some kind of neoplasm."
  The strongest position for the- registrant
was taken by Dr. Don Stevenson, Director of
Shell's TunstaU Laboratory, who testified
that evidence  of  human carcinogeniclty is
only sufficient when five criteria) are met:
  1. The exposed ""'•*««'« experience a higher
  3. Tumors  develop in  mare- than one
species.
  3. The development of these tumors can
be proven to be compound-related.
  4. Th» animal has proven to be an ade-
quate model for extrapolating to man.
  5. Human data Is available-, proving at least
one incidence of cancer that la compound-
related."
  It Is no exaggeration to say that Dr. Steven-
son's demands are  practically  Impossible
to  meet.1* Our knowledge of cancer  mech-
anisms  Is  still  Imperfect and 'it may take
many years before we understand the mech-
anisms  with  certainty. Furthermore, epl-
demlologlcal  studies are  difficult or Im-
possible to conduct on the effects of Aldrln-
Dleldrln.
  It is the carcinogenic effect of Aldrtn-
Dleldrln. not  the mechanism that concerns
us  here.  The evidence la  conclusive that
Aldrln-Dleldrln  is carcinogenic in mice.- It
has produced statistically significant com-
pound-related benign and malignant tumors
In the livers of five different strains of mice.
It also significantly Increases the Incidence
of  lung tumors.  This evidence of carclno-
gonldty Is supported by additional, although
not definitive, evidence that Aldrln-Dleldrln
has Increased the incidence of tumors In rats.
Dr. Upton,  a  recognized cancer expert, has
testified:
  In safety testing of carcinogens today we
are concerned with one question:
  Does exposure to the test agent result  in
a significant  Induction of tumors In ex-
posed populations as compared to controls?
If so, then the test agent has elicited a car-
cinogenic response and must therefore  be
considered potentially hazardous to human
health. Whether the agent actually Is a sine
qua non of the observed response or merely
enhances a virus or some other factor found '
in  the host animal is Irrelevant unless and
until we know that similar factors are not
also found in man. T/ntU  we have such
knowledge,  we have  no basis  on  which  to
matce distinctions   between  "carcinogens'*
  « EPA Ex. S-ll. 8 & 7.
  n Transcript 817-335.
  m Dr. Stevenson's position on the necessity
of proof for two species is particularly inter-
esting, since as Director of Shell's Laboratory.
ho feels that it is no longer fruitful to do
r search on rats. Furthermore,  in  spite of
Shell's strong position on the necessity for
human  data,  the Registrant Is no longer
studying Aldrln or Dleldrin's effects on man.
                                   FEDERAL REGISTER, VOL. 39, NO. 203—FRIDAY, OCTOBER 18. 1974

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                                                           65

                                                            NOTICES
 and "co-carcinogens" and "causative agents"
 versus "enhancing agents".
   Given tola lack of knowledge concerning
 mechanisms,  I  believe that a  carcinogenic
 reaction in any species of test *nim*i must
 be considered sufficient to describe the  test
 compound as a carcinogen and so a threat
 to human health. I consider that a similar
 reaction in a second mammalian  species  la
 a confirmation at the carcinogenlclty of the
 test agent but  it Is not  necessary before a
 finrtir.g Of carclnogeniGlty and threat to hu-
 man health  can be made; and  negative re-
 sults in a second  or even third  species of
 test  «n«mni  do not  In  my  mind establish
 that the test agent Is not a threat for  hu-
 man beings. Given the variation  in human
 susceptibility to  carcinogens, Z  believe  It
 unreasonable to ignore a finding of cardnc-
 jjeniaty  In any  mammalian  test  species
 when considering possible effects on human
 health."
   O. Body  burden and intake. There  Is a
 conclusive evidence that  residues of Aldrln-
 Dleldrln.  are  present  in   virtually  every
 member of the VS. population.  An EPA  Hu-
 man Monitoring Study has established  that
 In 1971. 99.6 percent of the persons sampled
 had Aldrln-Dleldrln residues in their adipose
• tissue.11 The compound also has been found
 la the blood samples of 69 percent of the
 population tested.1*
   In the environment,  Aldrin-Dieldrin  la
 most frequently present  In  food  crops,  and
 the consumption of food  has  been  man's
 principal exposure  to  the  compound.  The
 PDA's Market Basket Surveys  have shown
 that the  compound is  present  most  fre-
 quently In dairy products, meat,  fish, poul-
 try, and  fruits. Residues were  round in 83
 percent-IHJ percent of these products. These
 particular  commodities  contained  almost
 all of the Aldrln-Dleldrln residues found  in
 the Market Basket Surveys. Although the
 levels of these residues has fluctuated some-
 what, there  has been no significant decline
 in their presence in recent  years.19 Another
 EPA Monitoring Study has found Aldrln-
 Dleldrln  residues in 8S percent of the air
 samples taken."
   There is Inconclusive evidence on the rela-
 tionship between the intake of Aldrln-Dlel-
 drln and body burden levels. However, It ap-
 pears that the longer the exposure, the higher
 the tissue level." The concentrations of Al-
 drln-Dleldrln in the adipose tissues of the
 general  population  have been  found to be
 comparable to the levels  in  mice exposed to
 0.1 ppm of the compound.11 After exposure,
 species eliminate  the compound from their
 systems at different rates. Rats excrete the
 compound with a  half life  4 to 6 times as
 fast  as mice and 13 to 28 times  as fast as
 humans.**
  We are uncertain as to the precise effect of
Aldrin-Dieldrin on fetuses and infants • but
are concerned because their intake levels can
be over six times the so-called  Acceptable
Daily Intake (ADI)  level. Breast-fed babies
are  particular  susceptible,  as virtually  all
human milk has considerable Aldrln-Dleldrln
residue."
  H. Epiilemiological studies.  Epldemlologi-
cal studies on the corclnogenielty of Aldrln-
Dleldrln have been inadequate and Inconclu-
sive. Although It may be true that all known
human carcinogens have only been identified
through epldemlologlcal studies,  the identi-
fication of the carcinogenic effects of Aldrln-
Dleldrln through such  studies would  be dif-
ficult because there Is no member or segment
of the human population that has not been
exposed to the compounds."
  Shell has agreed that their epldemlologlcal
study does not prove that Aldrln-Dleldrln is
non-carcinogenic." Their tests detected no
effect among the subject population,  even
though some mortality  and morbidity was
observed,1* However no  conclusion  can be
drawn from these results because the teat
does not meet basic standards of accsct'.UU-
lty.*> The test population was too small, the
period of exposure  was too short, and the
medical observation periods were not long
enough to approximate the expected latency
period of at least 20 years  for Aldrln-Dlel-
drln.91

m. TBB USS9, BINCTIT3 AND lU-TTSNATTVES FOB
   n EPA Ex. s-ie, pp 4-«.
   •EPA Ex. 38, Tables I and n. EPA Ex. 5-
 18.  Other years deviated from these results
 Insignificantly. Individual  samples  varied
 widely from the mean of .27 ppm, with some
 as high as 116.53 ppm.
   n EPA Ex. 36, Table m.  .
   H EPA Ex. 38A, Table I and n. The average
 Intake In 1973 was-.002 mg/day. (.00003mg/
 kg/day). The  study has been criticized for
 having  too small a  sample and for  poor
 analytical methods;  Its figures are unques-
 tionably U.-V. (EPA Exhibit 30). (Tr. 15,281).
 Although the absolute Intake values  may
 not be known precisely, their relative values
 are evident from the study.
   » EPA Ex. 37. There is  evidence that this
 figure may be  low due to absorption In lungs
 and clothing.
   3 EPA Ex. 8Q.
   u Transcript 397-698. Thus it may diminish
 the relevance of placing the emphasis on
 the intake rather than the tissue level.
   » Transcript 899.
   A. Relevance of thf benefits Issue. In view
 of the foregoing health risks,  do the benefits
   " No tests have been performed on Infants
In  any species to determine their level of
susceptibility. However, some scientists con-
sider it to be quite high.
  •Transcript  32. The ADI  (.0001 mg/kg/
day for Aldrln-Dleldrln)  was established In
1966 long before  the most meaningful tests
were run on mice proving the  carcinogenic
effects of Aldrln-Dleldrln. Although the ADI
Is defined as a no-effect  level. It  is actually
a threshold level  based on a  rat study at 0.6
ppm In which exposed rats experienced liver
changes (Transcript 769)  (Shell Ex, 4, p. 16).
   "Many compounds Induced tumors of an
unusual type, which facilitated the identifi-
cation of the carcinogens. In other cases, the
tumor manifested itself in a distinct popula-
tion before there was a suspicion of corclno-
genlctty so  it  was  easy  to relate the effect
bock to the cause.  These situations do not
apply to Aldrin-Dleldrln. As  Dr. Gross testi-
fied: Even If Aldrln and Dleldrln were to pose
a very  significant danger to humans, really
an Impressive, even a catastrophic one. we
would never know this. (Transcript 323)
   - Shell S-t. p. 31:  Transcript SOS.
   "There was one  death in the high ex-
posure group of stomach cancer, but  this
death  was  considered insignificant. In the
same high exposure population, one worker
developed a tumor during exposure and an-
other, leukemia. It is Shell's position  that
the test showed no  Incidence- of enzyme in-
duction, liver injury, or  the presence of al-
phabets protein. From  this, they seem to
imply that  this is  evidence  that Aldrln -Dl-
eldrln Is not carcinogenic. However,  as Dr.
Farber has  stated, cancer can develop with-
out these symptoms. (See EPA Ex. 3-13). Dr.
Von Roalte takes  the lowest  level of ex-
posure in this test,  which la 17S  x the ADI,
and adopts  It as a no-effect level. (Transcript
p. 681.)
   » EPA Ex. S-17. p.  11.
   « EPA Ex. 8-10. p. 6. The average occupa-
tional exposure was 6.6  years; the average
observation period. 7.4 years;  and the average
age, 47.4. There were 169 men who were ex-
posed  at high does levels. (Shell Ex. S-t).
of Aldrin-Dieldrin Justify its continued use?
A related question la whether alternative pest
controls exist and will be available for the
1979 growing season.  The "availability" of
alternatives assumes several  factors, includ-
ing timely  registration,  effectiveness,  ade-
quacy of supply, safety, and economy.
  The  following  Integrated  discussion per-
tains only to the possible effects of suspend-
ing Aldrln-Dleldrln for the duration of the
cancellation proceeding.
  Since Aldrin-Dieldrin  has been  found to
be carcinogenic In mice  and probably car-
cinogenic In rate, and  to present a high risk
of cancer to man. It Is arguable that any use
of  Aldrin-Dleldrln,  however  significant or
beneficial in social or economic terms, can-
not be Justified, even  for the limited period
of time until the completion of the cancella-
tion proceedings.
  As indicated in part I of this opinion, how-
ever, it Is appropriate that the possible bene-
fits of Aldrln-Dleldrln, or the absence of such
benefits, be  considered  In  this proceeding.
Nevertheless, It is apparent that any benefits
attributable to Aldrin-Dleldrln must be of a
high order to affect the findings on carcliio-
genlclty.*3
  The following  sections, therefore, analyze
the major points raised in the hearing relat-
ing  to  uses,  benefits, and  alternatives, to
determine  whether  any of  these benefits
Justify the continuing risk."
  B. The significance of aldrtn-dieldrin uses
m corn. During the 1950's and 1960's, Aldrln-
Dleldrln became  the leading insecticide for
the control of several corn pests.9*  Prom that
period  of  widespread  application. Aldrln-
Dleldrln use  has declined to only about 8%
of the nation's total corn production  acre-
age."1 Changes in corn production over this
period gradually  have reduced reliance on
chemical  Insecticides  to sustain  high crop
yields. These changes resulted from a variety
of factors,  Including the  benefits of new hy-
brids, the  availability of synthetic nitrogen
fertilizer,  and advanced farm management
practices.0* These changes in cultivation also
have  helped to reduce- corn insect popula-
tions. Crop rotation practices and the  In-
crease in  soybean production in  the last
decade have  eliminated some of the favored
insect nesting  areas.

1971..: 	
1'JTS 	
1973 	
1974 (preliminary) 	

Acres
(million!)
0 4
7.6
7.4
4.9

Percent of
U.S. com
growth with
aldrin
12.9
11.0
10.3
7.S

  "EOF v. Bucfcelsnaus, 439 73A 584, 596 at
 note 41.
  "This  evaluation  does   not  necessarily
 mean that the final decision In the cancella-
 tion proceeding will be the same, for a wider
 range  of  topics  (Including other  health
 effects)  and  additional  evidence  on both
 risks and benefits will be considered in those
 hearings.
  MSee EPA  Brief,  pp. 181-183. citing the
 successes of Aldrtn-Dleldrln and Heptochlor
 In the 1960's' (Decker Shell Ex. 12). Sales of
 Aldrin peaked In 1966 (Shell Ex. Ill,  p. 38).
 and for corn use in Illinois In 1967 (EPA Ex.
 60. p. 9);
  " See EPA Brief, p. 207, citing 0SDA figures
 (Shell Ex. S-17A)  showing Aldrln use de-
 clined from 13.4 million acres In 1966 (202%
 of U.S. corn  acres  planted) to  7.6  million
 acres in  1971 (10.2%). The Doane  survey
 shows a continuing decline alnce 1971  as fol-
 lows: (EPA Ex. 3-16. p. 3).
  "See  EPA Brief, p. 1B3-188, citing testi-
 mony by Dr. Petty (EPA Ex. SO, p. 2-3)  and
 Dr. Palrchlld  (Shell  Ex. 8-16,  p.  12).
                                   FEDERAL REGISTER, VOL 39, NO.  203—FRIDAY, OCTOBER 18, 1974

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                                                              66
                                                             NOTICES
     ho recent hearing strongly Indicated that
      Incidence of significant Infestations'of
 the major com soil insects today is extremely
 lovtr. Per example. Dr. Petty testified that
 there were no major corn Insect problems In
 BUnoU in 1972." and Dr. Turpln stated that
 •vtrewonn  and   cutworm  populations  In
 iaduna were at  a very low level." A research
 team la Iowa, according to Dr. Owens, found
 teas thug ten wlreworm  incidents  In 1972
 and 1973. only two significant black cutworm
 Infestations, and no  white grub problems.1*
.   Corn fanners, nevertheless, continue to use
 large  quantities   of.  Aldrln-Dleldrln   as
 prophylactic   or  "Insurance''   protection
 against pote  '.al pest damage..even where
 an  actual th.cat of economic injury Is  not
 specifically determined; In other words,  the
 pesticide is used  even If there is no indication
 that It is needed.''*
   Aldrln-Dleldrln may no longer be as effec-
 tive or as necessary In controlling these corn
pests as has  been claimed  or as  bos been
 assumed by Its users. These doubts are due
 to  the developing  resistance  to  Aldrln-
 Dleldrln by some corn pests, the current low
 Incidence of corn insect Infestations on both
treated and untreated-acreage, and the lade
of recent data on the pesticide's continuing
potency.™
   C. Alternatives to aldrln-dicldrtn for earn.
The most important corn Insect pest is  the
rootworm. Since 1962. It has been known that
rootworms were becoming resistant to Aldrln-
Dleldrln.10*' and It Is now established that two
of. thtf  three  types of corn rootworms  are
resistant.™  In view  of the  fact that  other
Insecticides are  available to  control  root-
worm.1''* and the fact that Shell apparently
does not place major Importance on the use
of Aldrln-Dleldrln for rootworm control."9
com rootworm control does not present a
r-ivlnclng need for the use of the compound '
     373.
  " EPA Ex. 60A, p.' 109; Transcript (Cancel-
 lation) 11141-44. 1133; EPA Ex. 60, p. T.
  •"Transcript (Cancellation)  11482. 11493.
 11561; Indiana Survey for 1073-73, EPA Ex.
 61. pp. 32-26.
  •EPA Ex. 71;  see also the testimony of
 Dr.  stockdale.   Transcript   (Cancellation)
 32638. 22783. 22974.
  '"•See. o-g.,  testimony of various fanners
 that  Aldrln  has  been  used  as Insurance
 against  Insect  attack  (Oarst,   Transcript
 (Cancellation) 284; Decker. Transcript 162;
 Kirk. Transcript 22, 550; EPA Ex.  61. pp.
 34-33).
  » See testimony of Dr. Petty. EPA Ex. 61.
 p. 36; Transcript 11360;  EPA Ex. 60. p. 7;
 Transcript 11398; and Dr. Sechrtest. Tran-
 script 11794; EOF Brief HI A3.  pp.  7-9.-
  "» &:» EPA Brief, pp. 183-193. citing various
 sources concerning what appears to be a con-
 ceded fact in these proceedings. EPA Ex. 68,
 pp. 3-4:  Transcript 11074; EPA Ex. 60. p. 3.
  ""The two  resistant  species are Western
 and Northern corn  rootworm. See Recom-
 mended Decision, p. 83.
  "* Among the registered and recommended
 alternatives listed  by  EPA   are Furdan.
Thlmet,  Dasamlt. Dyfonate.'  Dlazlnon and
Mocap. Counter has a temporary use  permit
and Is -expected to be finally registered for.
rootworms and wlreworms by late 1974. EPA
Brief, p. 193.
  »•"• Shell apparently concedes that Aldrln-_
Dle!clr:n  Is not an  efficacious  treatment for"
 rofT-vrrms. No arguments for Its use on root-
 worm; ire set forth In Shell's  Brief No. V In
 the cancellation  proceeding or In their post-
hearing brief In the suspension proceeding.
 The Chief Administrative Law Judge specifi-
 cally found corn rootworm control not to be
    islderatlon with respect to the need for
    n-Dleldrln.   Recommended   Decision,
 p. o3.
   The black  cutworm  generally  Inhabits
 low-lying, poorly-drained river bottom land.
 heavy soils, and the low.  wet areas of upland
 fields. The loss in crop stand and yield from
 cutworm  Infestation can,  on occasion, be
 substantial.10*
   Wlreworm  Is the  third major com pest.
 It appears to be associated  with cropping
 patterns where corn-Is grown after sod or
 pasture, and  Is primarily a problem only In
 first-year  corn..Thus.  It Is generally not a
 problem  after the first year or where soy-
 beans and corn are rotated.
   The record Indicates  that registered al-
 ternatives are available  for all these pests.
 although Shell disputes- their effectiveness.
 For corn rootworms,  the alternatives Include
 Dlazlnon. Mocap, Thlmet, Furadan. Dasonit,
 and others. Most of these, and other chemi-
 cals..also an  registered as effective for con-
 trol of wlreworms. Alternatives registered for
 cutworms on corn Include Carbaryl. Dylox.
 and Dlazlnon. with registration pending also
 for Furadan.11*
   Minor soil  Insects, such as white grubs,
 seed corn beetles,  seed corn maggot, grape
 colaspls. corn  blllbug. Japanese beetle, Asiatic
 Garden  beetle, corn root aphid, corn field
 ant, flea  bottle larvae, or clover root borer.
.do not pose any significant economic threat
 to corn production.111* Where white grubs d»
 exist,  some   control can be obtained by
 organophosphates,  such  as  Malathlon,  or
 carbamates used to control rootworms; or
 wlreworms."*
   The record further  Indicates  that these
 alternative pesticides should be available In
 sufficient  quantities for the 1978 season.
 '•specially  since a pound-for-pound substi-
 tution for Aldrln-Dleldrln Is  neither neces-
 sary nor  desirable."* Shell's own estimates
 of available supplies  Indicate significant In-
 creases In production  of some  alternatives
 and continued high production  levels for
 most others."1
   D. Projections of  corn crop  reductions.
Corn production In the United States Is of
considerable Importance to the nation's econ-
omy.  Fortunately,  the suspension  hearing
record indicates that  the macroeconomle 1m- •
pact of the proposed suspension order would
be almost negligible.
   The most reasonable projection10 was the
study  conducted by  Dr.  Delvo of the XT.S.
Department of  Agriculture, who predicted
that corn crop reduction could amount to as
much  as  0.4%  of  expected production."1
  "» Sechrlest, EPA Ex. 63O. p. 3.
  «"EPA  Brief. Table,  pp.  176-177. Hepta-
chlor and Chlordane also are registered and
effective for certain applications. The Agency
does  not consider  them safe alternatives,
even though the scientific case against them
is not yet as complete as that against Aldrln-
Dleldrln.  (See also  p. 39. note 1).
  139 See testimony  of Dr. Turpln (EPA Ex.
61.  p. 40); Transcript (Cancellation) 11141,
15330-3.
  "•See EPA Ex. 60T, p. 88. showing some
control  of white grubs with band applica-
tions of Dasanlt, Dyfonate. Dlazlnon. Thlmet,
and Furadan.
  »»Hopefully, one result of this  decision
wiu be to reduce unnecessary "insurance-
applications of Insecticides and to limit their
usage to situations where they can prevent
significant economic Injury.
  111 Production  of Furadan. Dyfonate, and
Mocap.  among others, will be substantially
increased  next year. Shell Brief, pp. n-8 to
n-13: see also EPA Brief, p. 206.
  11S Judge Perlman  described  the  Delw»
Study, despite certain problems, as "the on
economic  study offering  some  reliance.'
Recommended Decision, p. 79.
  '"Shell Ex. S-17A.
  Even this-estimate may be considerably in-
  flated, aa EPA witness Dr. Aspelln. pointed
  out; because it (wnimn a level of wlreworm
  and, cutworm Infestation considerably la ex-
  cess of current field estimates.11*
   A second study was conducted for Shea by
  Doane Agricultural Service. The fanners' loss
  estimates were  ten times  as  high  aa  tha
  Delvo prediction, plus another five times du»
  to  a claimed shifting of  production from
  corn to another crop.0* This projection seems
  somewhat high, considering that  Aldrln-
  Dleldrln la used on less  than 8%  of  the
  nation's total corn" crop. Shell has conceded
  that  "because  of  certain  methodological
  problems and the questions concerning  the
  ability  of farmers  to make estimates, Mr.
•  Wllkln's estimate, may be too high.** "•
   A third study.'conducted In 1973  by Or.
  Freund, assumed the simultaneous unavail-
  ability not only of Aldrln-Dleldrln but also
  of  Chlordane and  Heptachlor,  and  conse-
  quently projected losses in the range of 0.7
  to  1.8  percent. This  "very rough study."
  which* was  clearly1  "tentative  and  pre-
  liminary." cannot constitute a reliable basis
  for'a conclusion on macroeconomle impact.10'
   It is possible'that there may be no crop
  reduction at all due to the lack of Aldrln-
  Dleldrln. For fields  with significant insect
  damage to the young plantsxcrop loss can be
  greatly reduced by Immediate, replanting and
  treatment with an  alternative pesticide.'"
 This I? a common practice and may be less-
 expensive overall than extensive prophylactic .
  treatments used by many-formers.
   2, therefore, concur in the finding of Judge
 Perlman who, after reviewing the  above
 studies and projections, concluded: "On the
 basis of the  foregoing, we cannot find any
 major economic or social  benefit resulting.
 from the use of Aldrln on  corn in the con-
  text of overall effect of Its unavailability for
 such use." "»
   E. CUrua uses of oldrtn-ileldrfn. Although
 the benefits portion of the suspension hear-
   "•Ibld.
.   °* Shell Ex 168.
   »shell  Brief, p. n-19. The hearing ex-
 aminer  concluded.  "We totally reject the
 Doane  Agriculture  Service;  ffrq.  special
 survey and projections of loss • •' ». On. Its
 face.  It la  patently  exaggerated,  employs
 'double counting compounded,' is based on a
 small sample from which averaging.projec-
 tions are  made and  elicited  the  views of
 Aldrln users who would not in reality know
 with any precision the effects of'the absence
 of Aldrln  and who, it seems  to us, would
 demonstrate a bias." Recommended Decision,
 p. 79.
   ut Recommended  Decision,  p. 79. Even
 though the  EPA staff believes that Hepta-
 chlor and  Chlordane pose  a "substantial
 question of safety" sufficient to initiate the
 cancellation process, and therefore does not '
 recommend them as alternatives, as a factual
 matter these compounds will be available for
 the 1973 growing season: The fact that the
 Agency has not yet Initiated administrative
 proceedings on Heptachlor and Chlordane Is
 not. relevant to  the  hazards  of  Aldrtn-
 Dleldrln. It would be extremely irresponsible
 to refrain from banning the  use of  one
carcinogenic  compound  because   another
 compound  might  also  have  carclnogMile,
 effects.
  ,"• Shell Brief, p. 10.
   «*» Recommended  Decision, p. 81. Regard-
less of minimal economic Impact at the na-
tional level,  it la always possible that some
Individual  farrrier3J'ma.y - bo  more  disail-
 raatoged than others by the suspension of n
rarttculor pesticide, it Is my Interpretation
 i the F1FRA. however, that these burdens on
.r.dlvldual farmers must be sevtre and wide-
spread to Justify ;xr--wing tti* entire popula-
tion to a demondt.-aced carcinogen.
                                  HDMAL REGISTER, VOL 39, NO.  203—MIOAY.  OCTOBS.U  18.  1974

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                                                            67
                                                            NOTICES
ing dealt almost solely with can, there are
a  number of "minor" uses for which  the
Department of Agriculture (TTBDA) contends
that Aldrln-Dleldrln la eiBHmtial. The most
Important of these la the use  on various
'citrus pests In Florida.1*
  Aldrln-Dleldrln and  other inseetleides for
control of the Puller  Hose Beetle  are only
•used on 1-6% of citrus acreage in Florida.10
Even in the Indian River area of Florida, son
Insecticides have been applied only to some
30% of the acreage."1  As  with corn. Aldrtn-
Dleldrln has been used  extensively for "insur-
ance*" protection on citrus* where actual eco-
nomic  risk has  not been specifically deter-
mined.13'
  Other Florida citrus peats  include  the
blue-green citrus weevil and the sugar cane
root stalk borer weevil  (diaprepes) . but these-
are very limited problems, both geographi-
cally and la magnitude. Only about 1% of
Florida citrus acreage is subject to weevB
tufjMttatltfflj ?***!  of *****  Aldrln^ieldrln .Is
used on somewhat more *>*«"* one-half.1"
  Although fewer acres of citrus than con
are treated with  Aldrin-Dleldrin. the.rate of
application per acre id considerably higher.
Whereas the  rate  on com is  one to  two
pounds per acre, the  rate en euros la  five
pounds. These "minor" -uses on Florida citrus.
therefore,  account for  130,000  pounds of
Aldrin-Dleldrin a 'year.1**             .  '
  Alternative  foliar sprays and organophos-
       soil inT*rfei^'1a questioned whether  Aldrln-
Dleldrln remains  effective   against  citrus
pests. The most recent test waa conducted
16 years ago by Dr. King, who concluded that
  "1rm was  only effective 70%  of the tune.
   P Brief, m-B, p. 52,
   F. Seed treatment usoa o/.4IdXn-DieIdrm.
• Aldrln-Dleldrln Is used in seed dressing'for
 many types of grain, fruit, and vegetable
 seeds as a prophylactic measure.'" normally.
 only two to four ounces of dressing per 100
 pounds of seed is applied,  either In commer-
 cial seed preparations or by the farmer dur-
 ing planting."* This amounts, however, to
 130.000 pounds of persistent Aldrtn-Dleldrtn
 entering *** environment per annum.13* This
 hazard Is unnecessary,  for alternative seed
 itia«^|itq«  are  available? Dlszinon, Fif1**^11^
 and BHC (in Canada) are used effectively for
 this purpose.  Proper cultural practices also
 can reduce ***** need for seed treatment.
   There Is, therefore, little or no evidence
 that Aldrtn-Dleldrln seed dressing is needed
 to prevent "tgr^W**"1*  g»i*tfti or economic
 Injury. •
   Q. Other minor uses o/ AUHn-DUUrta.
 Many other uses  of Aldrln-Dleldrln, Includ-
 ing Puerto Rlcan  pineapples, sugar cane, and
 H'MiflTiflfi ftni^Tia arowu in the Tulelake **«*«*"
 of Northern California,  strawberries in Ore-
 gon and Washington, the TSDA's quarantine
 program."" cranberries, and  nursery  stock,
 are dnfended by the TJSDA in this suspension,
 proceeding. Registered  alternative  insecti-
 cides are available for these uses during the
 period required  for the 'completion of the
 «m«.n.«nT, proceeding.^ Registration of ad-
 ditional alternative Insecticides is pending.
   With respect to these other uses, there Is
 no oasis on the record to conclude that slg-
 ntfltHmfe-yiMa^ rpf ff^ff^fffn^n mJUTJf tO ^* ftft-
 tion or to individual growers would result
 fiiuii tne suspension of At*^^^-^***1*^11
   »See. e*. Transcript (Cancellation) 3468:
 3335; 3263.
   "•See Transcript (Cancellation)  23766-7;
 33791.

   » The M"»  of • Aldrin-Dleldrin to  of the cancellation
 proceeding.  Further evidence  and  further
 consideration in
   1. .Based on the testimony of record in the
 suspension hearing and the considerations set
 forth in Part n of this opinion, X have con-
 cluded fl<»*  the  continued use of Aldrin-
 Dleldrin during the time required to reach a
 final decision in the cancellation proceeding
 would  be likely  to  result In unreasonable
 numan health  risks •"*•*, -therefore, that an
 ••imminent hazard**  within this  tmnmt^ig 'of
 section 3(1)  of FD7RA would result during
 the pendency of the 'oanoeUatlon pp>*«*«HiTig
   3. I have concluded further, based on the
 testimony of record ttl^ t^^ iy%ti^rfo|^^j^n«
 set forth  In  Part m of this opinion, that
 there are. no ^QUBt4fni<*j^*t*g'bftpftfltB resulting
 from the  registered  uses of Aldrln-Dleldrln
  dif-
 ferent conclusion regarding Aldrln-Dleldrln
 use on citrus or seed' treatment. Such con-
 clusions, however, cannot be reached on the
 basis of .the suspension hearing record.
   4. The effect of this decision  will be to
 severely restrict the amount of Aldrln-Dlel-
 drln which wfll be placed into the environ-
 ment during the 1875 growing season. It will
 not completely curtail the  vMltlgn of these
 compounds into the environment, since the
 use of existing stocks 
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      68
Appendix     B

-------
FEDERAL REPORTER
            econ
         Volume 510 F.2d
             in tli,
   UNITED STATES COURTS OF APPEALS
    UNITED STATES COURT OF CLAIMS
   UNITED STATES COURT OF CUSTOMS
       AND PATENT APPEALS
             AND
 TEMPORARY EMERGENCY.COURT OF APPEALS
          ST. FAtrt. UZHV.
       WEST PX7BLISHING 00.
            1976

-------
        1292
                                                      70
                   510 FKDKRAL REPORTER, 2d SERIES

I
trial, we think the witness.under exami-
nation  may  nut  tic asked to pass  upon
tin; mental condition of those artists.  To
do .so raises collateral  issues foreign to
tin: trial or  appellant.  Morwivcr, the
|i:iinline of ap|»ellanl referral to by his
witness, if  they  can lie niailc available,
tthniild  lie exhibited to  the jury for com*
purr.dn  with  any paintings of the  well-
known artists which might In* exhibited.
Unless these  precautions,  with any oth-
iM1* thought  appropriate  by  the   trial
jndpj, are taken, the proceedings Iwcomc
so misleading us  to l>e quite unfair to the •
jury and, therefore, to  appellant We do
not question, however, the right of the
prosecution to seek to refute  liy expert
testimony the appropriateness of  using
the paintings of  a patient in aid of diag-
nosing his  mental condition.
   When considered together  the several
difficulties we have noted affecting the
second pha.se of  the trial combine to lead
us to reverse the verdict on the insanity
iiisuu and  to  remand  the case in that
reaped for further  proceedings consist-
on!  with  this opinion, while affirming
the verdict reached on the first phase of
I lu* bifurcated trial.
   It is  so ordered.

     SUPPLEMENTAL OPINION
  FAIIY,  Senior Circuit Judge:
  The  opinion of  the  court of  April 7,
1975, 1G7  U.S.App.D.C.  	, 510  T2A
1283, 1288, refers to a motion  of stipula-
tion proposed to be filed  by counsel for
appellant correcting, as erroneous, a por-
tion of the transcript  of Uie trial  relied
upon by the United States as constituting
a waiver of apiiellaht's claim of right to a
separate jury.   Our opinion  slates, "we
have received no stipulation  or motion
   .  . ." The fact is an order of the trial
judge  correcting the record, baaed on a
stipulation of counsel for the parties, was
filed prior to argument of this case, but it
was not brought to the attention of the
court until subsequent to issuance  of the
court's opinion April 7, 1975.  The stipu-
 lation and order confirm the  analysis of
 the transcript in all relevant  reflects a*
 made  by  the court in its opinion.
                                                ENVIRONMENTAL DEFENSE FUND,
                                                     INC, and National Audubon
                                                         Society, Petitioners.
                                                                  v.              ...

                                                  ENVIRONMENTAL PROTECTION
                                                    AGENCY and Rumwll E. Train,
                                                      Administrator,  Respondent,
                                                 Shell  Chemical Company and Earl L.
                                                    Butz, Secretary of Agriculture,  .
                                                              Intervenor.
                                                   SHELL CHEMICAL COMPANY,
                                                      DIVISION  OF  SHELL OIL
                                                        COMPANY, Petitioner,
ENVIRONMENTAL     PROTECTION
  AGENCY and  Russell E. Train, Ad-
  ministrator, Environmental Protection '
  Agency, Respondents.

    FLORIDA CITRUS  MUTUAL,
              Petitioner,
                  v.

ENVIRONMENTAL     PROTECTION
  AGENCY and  Ruaacll E. Train, Ad-
  ministrator, Environmental Protection
  Agency,  Respondents.

Earl L. BUTZ, Secretary of Agriculture
    of  the  United States, Petitioner,
                  v.

Russell E. TRAIN, Administrator of the
   Environmental Protection Agency,
              Respondent.
     Noa. 74-1924, 74-2113, 74-2114
             and 75-1092.
  •  United States Court of  Appeals,
      District of  Columbia  Circuit.

         Argued- Feb. 7, 1975.
         Decided April 4, 1975.
                                                     On petitions for review of an order
                                                 of the Environmental Protection Agency
                                                 suspending the registration and prohibit-
                                                 ing the manufacture and sale of the pes-
                                                 ticides aldrin and dicldrin, the Court of
                                                 Appeals,  Leventhal, Circuit Judge, held.

                                                                                                  !.,
                                                 i
                                                 \'\
inter al
rationu
ported
and si
and (2
the su
 parte <
 onforv
 Involv-
 hcorii
 consul
 and a
 cept i
 suspe.
     . 5
 that
 stock
 furtl:


  l.; P.

  ordc
  proh
.  the
  rat'n
  port
  and
  Fed
  Act

  2.1

   fln<
   imt
   qui
   evi
   da i
   ic
   coi
   tio
   at
   of
    al
                                                             VI
                                                             m
    tl
 '  ii

-------
                                            71
                                       •4
      KNVIIIO.NMKNT.tt, T).  R, INC. v. ENVIHONMKNTAL PRO. A«CV.  1293
                              nil- •* (kill KM ISM I Illttl
   itr itlia, lh:ii. (1; Lhc EPA's order WIIH a
rational  exi-rri.w of  ili.sriv1.ion  anil sup*
|HI failed In establish that
the .tuspcni'ioii order was tainted  by ex
parlc commui'ii-al.ions. from the Agency's
enforcement  clnil',  who were  at the time
involved   in   a continuing  cancellation
hearing;   rather, there was  no claim of
consultation  U.a.veen  the prohccutorial
und  adjudi'-ativc stuff of the  Agency ex-
cept on  tli'.-  issui; of whether to  start u
suspension pn.ivi'iling.
     Siis|>::ii:iii»•!)(Iin|,'  the registration  and
•>ri>hibiliiitf  (in:  iuaniifactun; and snlc of
.he  pesticides aMrin and dieldrin  was- a
rationale. c\cii-i--': of discretion and su|>-
^icrlcd  !>y thv.-  reasoning of the Agency
t.nd  sulislanluii  evidence  in  the reconl.
Federal Environmental Pesticide Control
Aet  of  l!>7i>, §  Oc), 7 U.S.C.A. § 13(kl(c).

2. Poisons ^=»2
     Knvironiti. '.i:d  Protection  Aycncy'a
finding thai :;'i!:-in/dieldrin presents "an
imminent  ha/nnl  during the  time  re-
quired  for rain>.!lHtion" hud an adequate
evidentiary  I ;i; is,   including  scientific
data that I he p'.stiddes were carcinoKen-
ii* in mi<-u  and r.ils, and- that  a  causal
connection exists between the iinplunla-
liun of lh2
     Within provision of the Federal En-
vironmental Pesticide  Control  Act  per-
mitting the  suspension of a  registration
while  a cancellation hearing is pending
when   ."the  Administrator  determines
that action  is  necessary  to  prevent an
imminent  hazard  during  the   time  re-
quired  for cam-elation," the term "immi-
ncnt hiuarH"  is not limited to n concept
of crisis;  it in enough  if there is a sub-
stantial likelihood that  serious harm will
be ux|x:ru:ncuut places the  burden  of estab-
lishing safety  on the applicant und regis-
trant.   Federal Environmental  Pesticide
Control Act of 1D72, §  6(c), 7 U.S.C.A. §
13Gd(c).

5. Pol.sonu «=»2
    Conclusion  of  the  Administrator of
the  Environmental  Protection  Agency
that  the  pesticides aldrin  and dieldrin
present an  "imminent hazard" to  man
because the (raticides are carcinogenic in
mice and probably carcinogenic  in rats aa
well was a conclusion within the scientif-
ic expertise of  the Agency and was not
infected by error of law;  likewise, the
validity of extrapolation to humans from
data derived from teals on animals was a
matter within  the  Agency's  expertise.
Federal Environmental Pesticide Control
Act  of  1972,  § 6(b,  c),  7 U.S.C.A. §
13Gd(b, c).

6. Poisons o=»2
    Although  extrapolation  of  cancer
data from mice to man may be quantita-
tively imprecise, it is sufficient to estab-
lish a "substantial likelihood"  that harm
will result from Ihc  use  of  pesticides
found to be carcinogenic in mice.  Feder-
al Environmental  Pesticide  Control Act
of 1972. § 6(c). 7 U.S.C.A. § 136d(c).

7. Administrative  Law  and  Procedure
       «=»502
    An agency is not required  to adhere
to a  prior policy with iron  rigidity;  all
that  the  law  requires  is that  it explain
the reasons fur a  modification.
      I
      ;j
      i!
      ir
      (i
      «i
      i!
     II
 ''*
SM
l*\l':.
, .1
II
s
it
a
i
1
j(
il
.
:•
•
r
i
,
't

i
    ! I
     I1
     I!
    I,
?!:,
f;'
'*;'
:ii-
 '••&
  \..
' •:••}'•
•  '.r. I


 1
^
 i
                 I
                I
                "-*i
                i

-------
  I
                                                   72
              1294
510 FEDERAL KKI'OKTEK, 2d SERIES
              8.  Poisons <*=>2
                  His previous refunds on a different
              record,  to aus,«nd  the rc,..i.stration  of •
              aldnn and dicl.lrin did not strip the Ad.
              ministralor of the Environmental Prolec-
              lion Agency ?f discretion to make a |H,li-
              cy  judgment that, Ixtausc of new infor-
              mation elicited, the uncxjxsct.',) length  ,.f
              cancellation  hearing  nn.l a thr^il liy tl.o
              manufacturer lo commence pr,Nluc«ion  ,,f
              the pesticide*  for the 1975 souson. the-
              nsk posed  by  the registration  hud in-
              creased significantly  and suspension had
              become necessary.  Federal Environmen-
              tal  Pesticide Control  Act of 1D72. § GH,
             c),  7 U.aC.A. §  13Gd(b. c).          '
             9. Poisons  «=»2
                 Record   supported   Environment N I
             Protection  ARCMcy's finding,  in supporf.
             of Iho  suspension of  the  registration of
             aldnn  and  dicldrin.  of  a  "..utataiiii.il
             likelihood"  that  serious  harm  to mn,,
             would result  from the continued use of
             the  pesticides for the treatment of ccrn
             601   insect*.   Federal Environmental P2
                        Conclusion  of the Administrator of
                        Knvironmfint.il Protection Agency, in
                         -rt of order .sus|K?nrtt IKISO the
                    swmo  cancer  risk  as aldrin and dieldrin
                    snp!K,rted the fin.linff \hat available al-
                    lor.-,atives  were  environmentally 9uit-
                    «l>io.   Federal  Environmental Pesticide
                           Act of l972.-§  6(b. c). 7 U.S.C.A.
            10. Polaonn
                It is not nccc.ssary. to have uvideneu
            on a specific use or aren in ortlcr to IK;
            able to conclude on the basis of gubsUin-
            Ual evidence that the use of a jwsticide
            in  general is hazardous and that the rcir-
            istration  of it  should therefore  be sus-
            pcnded.  Federal  Environmental Pcsli-
            cide Control Act  of  1972. §  6(c}, 7  U.S
            C.A.  §  136d(c).

            11. Poisons  «=»2
               Manufacturer of the sus|>cnded  pc3-
            Ucides aldrin and dieldrin. which-  were-
           shown to create a risk of cam-er in hu-
           mans, failed to  cst:dj|ish that the bene-
           fits  derived from  the  |>cstici,le*  out-
           weighed the harm done by them.
           12.  Poisons  <=2
               Responsibility   to  demonstrate  that
           the benefiu outweigh  the risk is upon
           the proponents of  continued registration
           of  a chemical poison.
           13. Poisons  c=>2
               Where  the  KnvironmcnUd   Protec-
           tion Agency  declines to suspend  the rcg-
                    15. I'oisbna o^'J
                       When the .-iiiliject is risk of cancer.
                   i-onvi-nicncc may !>e relevant but it does
                   "••I. weigh' heavily in determining wheth-
                   er the registration of certain pesticides
                   shMjId be  su.sK-n.Jod.   Federal Environ-
                   f:i-..-:ital PcHtici2
                       While a more careful exploration of
                   t.-ir  .lyailuhiliiy of alternatives for minor
                   U.VM would he contemplated for the final
                   duir-rmination  on the  cnncellation  vcl
                   "•>n  <,f the rrpslration  of the paslicides
                   i'.l'lnn and dicldrin, no such extended dis-
                   oussion of the rvidcncc could be demand-
                   -.'.I for every use of those  pesticides at
                   ihu ciTii-rgcncj-, provisional stage involv-
                   ing .^sponsion of the registration.  Fed-
                  eral  Environmental Pesticide Control Act
                  of 1&72, § 6(b. c). 7 U.S.C.A. §  136d(b, c).
                  17. Poisons «=>2

                     Notwithstanding  claim that findings
                  of the Administrator of the Environmen-
                  tal Protection Agency were too incom-
                  plete  to be  adequate for an order  sus-
                  pending the  registration  of aldrin  ami
     I
:!
'«

-------
        KXVIUONMKNT.AL D. P., INC. v
 dieldrin, it was sufficient, in view of Hut
 statutory  time constraint  under whi.-ii
 the  Administrator aclud, that there was
 substantial evidence  in  the record nrul
 that the reviewing court was able to dis-
 • ccrn tlic  fair imjwrt  of .the Administra-
 tor's reasoning.  Federal  Environmental
 Pesticide  Control Act  of 1072, § G(c)(2) 7
 U.S.C.A.  § 13Gd(c)(2).

 18. Administrative  l.aw  and  Procedure
.  KNVIKONMBNTAI, IMIO. AfiCY.   IMK
•.2ill2K!ll'.lV.-,|
  eral Knvir'iiiniunlnl Pwlicidu Control Act
  of  197::, fc <5(c). 7 U.H.f:.A. <
     Where  the administrative  record is
 complex and  the  time  for explication
 brief, judicial review is conducted on  Ihe
 basis  of the record as a whole, so that
 rather  conclusory  findings  can  l»e  re-
 deemed by  resort  Ui  a detailed  factual
 record.

 19.  PolsonH  c=»2
     Record  failed to establish that Envi-
 ronmental Protection  Agency order sus-
 pending the registration und prohibiting
 the  manufacture and  side of the |>esli-
 cides aldrin  and diclilrin was* tainted  by
 ex partc communications from the Agen-
 cy's enforcement staff, who  were at the
 time involved in a continuing  cancella-
 tion hearing; rather, there was  no claim
 of consultation  between  the  Agency's
 prosecutorial and adjudicalivc staff, ex-
 cept on  the  issue of whether to start, a
 suspension proceeding.   Federal  Environ-
 mental  Pesticide Control Act of 1972, §
 6(b,  c), 7 U.S.C.A. § 13fid(b,  C).

 20. Poi.sonq  c=>2
     In rcspert to October,  1974  Environ-
 mental Protection Agency order  suspend-
 ing ihi!  registration and prohibiting the
 manufacture  mid sale  of the (Katici'dus
 aldrin  and diclilrin,  that part of the or-
 der exempting existing stocks of the pes-
 ticides would be  remanded  for further
 consideration,   as  the   Agency   was
 presented in January of 1975 with esti-
 mates that approximately five percent  of
the total 1374 amount of aldrin granules
would be available for use in  1975.
• Silling by designation pursuant to 28 U S C «
 293(a)

U  The suspension order covered nil pesilritlr
 products containing  uldrin  or  dielUrin  for '
 which  apiwuU had tui-n fllctl  from EPA's
 June 2li. 1972. notice of e.inccllutlon.  Certain
              for review of an ordor of the
  Environmental Prolr-vlion Agency.
    William A. Butler, with whom Jacque-
  Hne  :>f.  Warren,  John  F. Picnelt,  and
  John T. Shinkle, Washington, D. C., were
  on th«r  t.ri<.'f for rxjlitiuncrs  in No. 74-
  1924.
        iis  a Lyons, Washington, D.  C.,
  with wh.-m David  H.  l.loyd,  Andrew S.
  Krulwich,  and  Linda  F.  Blumenfeld,
  Washington, D. C., wen: <»n the brief, for
  petitioner in No. 74-2113 also  argued for
  petitioner in No. 74-21M.
    Raymond W. Fullerton, Atty., Dept. of
  Agricul'.iinr, with whom John  A.  Knebcl,
  Gen. ('-t, James Michael Kelly, AsaL
  (Jon. Cinmsul, and Uinhard  S.  Wnsser-
  strorn, Atty., Dept of  Agriculture, wt:ro
  on the brief for petitioner in  No. 75-
  1002.
    Churl.*  W.  Line, III, N«w  Orleans,
  La., was  vn  the  brief  for petitioner  in
  No.  74- 2114.
    Mirha.tl  II. Stein, Atty., Dept,  of Jus-
  tice, with  whom Carla  A,  Hills, AasL
 Atly. C}...n.t  Stephen F.  Eilpcrin, Atty.,
 Dept. of  Justice, and  William- E.  Reu-
 kauf,  Atty.,  Environmental   Protection
 Agency,  were  on the  brief for respon-
 dents.

   Befoev  WRIGHT antl  LLCVENTHAL,
 Circuit  .rU''.ges,  and   DAVIS,*   Judge,
 Unit.Ml Stales Court of Cluims.

   Opiitiini for the Court  filed  by  Circuit
    '    I.KVENTHAL.
   LKVENTHAL, Circuit Judge:
   This CJIA»J involves  tlie validity of  an
 order is-simd by the Administrator of the
 Environinrohibiting the manufacture
 and sale ' of  the pesticides aldrin  and
   minor usv.t— (he dlppiiiR of roots or tops of
   noii-foxJ plants, subsuifaue ground insertions
   for  termite control,  ami mothproofing  by
   thoso manufacturing procctsrs that utilize the .
   pesticide in a closed system— were exempted
MI ;
             .. r ,

             •:??«
            . •.•.tf.s

-------
                                                                                  it:
1296
                     510
     „,„,  Silr,
              „

                       IWe
                                          '••>*
                                                              '•  THE  ORDEU
                                                      » Occumlicr  3.  107n  pnt'  r
                                                      wl                  '   "*  flrst
                                                      of
                                                     anc
                                                                ns
                                                      Admini.,lrator  l
                                                      to cancel.
                                         seed-   rnfr lhat <
                                  It.
 greater quanittirs.   [„  ,37," "5<'J ln "«uch
 million pounds of  aMrii,       "°St •tWelv*
 only about 7oocoo imi,.!!. W
-------
                                        75
                                -'•'ili'iiui "Li
KNVIKONMKNTAI. t). F, INC. v. ENVIRONMENTAL Pl'lO. AfiCY.   JV
  me:nl  of a public  hearing.'  When  EDF
  sought review in Ihi* court of Ihu refusal
  lo sus|>end, we remanded for further con-
  sideration in light of the  Ileport of the
  Advisory Committee, which was issued on
  March 28, 1912.  Environmental  Defense
  Fund. Inc. v. Environmental Protection
  Agency, l.r>0  U.S.App.D.C.  348, 405  F.2d
  028 (1072).  After considering the lle|»ort
  and  further public comments, the  EPA
  issued an order on December 7,  1972,
  which  affirmed im  previous  decisions to
  issue a notice of intent to cancel,  without
  interim susitension.
   Cantx-llation  hearings  began   before
 Chief Administrative  I«aw  Judge (M.I)
 Perlrnan  on  August  7, 1973.   Twelve
 months into llu>  hearings,  on August 2,
  11)74, UK; Administrator issued a nutir:e
 of intent  lo sus|iend on the ground  that
 evidence develop! .since Dccemlier  1972
 indicated  that the continued  use  of  uld-
 "•n/dieldrin presented an "imminent  haz-
    "  lo Ihe public.   Shell and USDA re-
   oslcd a public  hearing on the su»|x.-n-
 sion question.  The  hearing  began before
 ALJ  Pcrlman on August  14, 1974,  and
 wart  concluded on  September 12, 1974.
 ALJ  Perlman recommended  suspension,
 and, on Oclol>er 1, 1974, the Administra-
 tor susjxjndt-d the registrations.
   We will first develop the  general pur-
 pose  and validity of the order, with  a
 brond overview nf its reasoning and  the-
aup|K>rling evidence.  Then we shall turn
lo certain particular objections presented
by the  parties.
      II.   GENERAL  VALIDITY

  [1]  Turning first t0 the broad  ques-
tion of validity raised  by cases  like this,
the court concludes:  The  EPA's order is
a rational exorcise of  discretion, rather
than arbitrary agency  action.   It is su|>-

«.  Undir the terms of I la- Act applicable ut ihe
  lime, the report  of the  Advisory Committee
  wn» lo issue before thr comim-neetnent of the
    ninisiruiive hearings.  $ 4(c),  78 Slat. 130 '
    «).  Thai provision was amended in 1972
    provide that the lu ;inn« oxaminw could, at
  his own o(ition or at die  request of any parly,
  refif rclrvnnt question* of scii-ntific fact to "a
    310 f .2J—»J
                                             ported liy'lhu  iXM
                                             and  by   substantial
                                             rccaH.
                                   A.
                                                             of the ar.'.-ncy,
                                                          evidcnoi  in  th<|
      The .SVri/x.- nf .Imliciul Ru\-ic\v
    [2)  The primary challenge rnist-1 by
  Shell, FCM, ami  tl,,- UHDA goes  to the
  adequacy of the- evid.rnliury basis  of the
  EPA's    finding    that    aMrin/dicldrin
  presents  "an imminent hazard  [to :rian|
  during  the  lirni-  rvrpu'red  for  <-anrelh-'
  lion."

    [3,4]   We  have   cautioned  that  the
  term "imminent hai-a.-..'" is not limii.-ii to
  a concept of crisis:  "II is enough if there
  is   aulmtuntiul  //A<•/!/;.„*/   that  ^-ri.ms
  harm  will  be  rtcd

  Committee of the Nuiionnl Academy of Scl-
              7  U.S.C. (j  I3r><|(d) (Supp. II,
                                 7.  If no  request  for a hearing  i, IT)atll.  lhe
                                   suspension order takes efit-ci and is not re-
                                   viewable by  n court.  § (J(r)(^. 7  U.SC S
                                   ia6d(r)(2) (Supp. ||f ,972).           A" *
                                                       •'I
                                                                                         :
                                                                                    r
                                                                                    11'.'
                                                                                    •Vj.  .
                                                                                    (M-l  •
                                                                                    !;:'!  •
                                                                                       '
                                                                                    )li
                                                                                    11.
                                                                                    i  f.
                                                                                      I'i

-------
                            76
   1298
                        510
                                      »BPOl«TBR. 2d SERIES
                     evidence  when  con-
            on the record as a whole."
                «f "substantial

          support
   In applying this principle to rcv.W of
 a suspense decision, this court has said
  me function  of the suspension d   ' '  '
 13 vO fll&JCG A  ni*ol it** i **n •••
      ••••»f%«= n  tircurninnry &ssc$Sfncnl of
 evidence, and  probabilities,  not an  ulti-
 mate resolut.on  of difficult issues    We
 cannot  accept  the proposition   .
 that the Administrators findings   '  '
[are]  insufficient because  controverted
by  respectable  scientific authority.  It

VS^S*^?" ^ lh« i--
                 ..  -••—"i«j  icapvcuiUlO
 «•  • .  ,  authority supporting thc  Ad-
 ministrator."    Environmental  Defense
.Fund.  Inc. v.  EPA, supra,  150  USApp
 u.C. al 357, 4C5 F.2d  at  637.          '

 B.  Carcinogcnicity of Aldrin/DicMrin
   Although the  cancellation  hearing  en-
compasses a broad  range of issues con-

^"elfviriL^r1  °f  aldn'n/tlicldrin  «"
L  •    I*         '    " Cll  39 Oil  llUItlllfl
DC'np,  the supenaion  hearing was con-
fined to whether the pesticides present a
cancer hazard  to man."   The Adminis-
   trator   concluded  that  aMrin/dieWrin
   presented an vjlnniinctit Inward" to man
   on the  basis of data indicating that i; is
   carcmogcnic in five trains of mi«j and
   as corroboration.  indications that  "t>«r«
   is a strong pn^nhiliLy that Aldrin-Diel-
   drm is  a carcinogen in ra* M w.c|,
   mice. '*
  1.  Mice Data

    Shell  attacks the Administrator's re-
  liance on  mice  data on the ground th^
  thc inadequacy of  present knowlc^M re-
  garding  cancer and the difficulty of CT
  trapolating from mice to men render'ha
 decision  speculative.

   f5J  Thc Administrator's failure 10 ce-
 tcrnune a threshold level of erno9t,«% .,
 n Irli^ y*j "ii"                •»i«'S^irv 40
 minalCn"     d°C'3 "^ ^^ his det*"'
 minauon  .mpro^r,  for he has concluded
 viiai me concept of u thr^sholrl
 level  has  no practical significanrcChe-
carcinogens arc  concerned.  This \A   "
m part to  thc  ir'rcvcrsibilitv
latency period of carcinogens'
                                                     as cancer," » and the
                                         «te places  the  burden on the
                          130n(b>
                                                 -  ass-minp  a  sulstantial show.
                                            of_ danger, require  the Administrator
                                        to make impossible proofs.  In r
                                        admimslrativc  actions, courts
                                        fairly demand the perfect at the
                                        of the  achievable.""  The  AdmmUirn-
                                        tors conclusion is within the scientific
            to support a conclusion."        "•

                                           A.O. 7.
                                           A.O. 23.

                                        manAxJ  417 US  ^L^"1^  an>l  "'
                                                                     3I67'  «'

-------
                                           •  ?77
         KNVIliONMENTAL I). F, INC v. ENVIRON.MKNTAL PRO. ACCY.
        li.*e of the  agency, ami  is  not in-
  fected by error of law.   Compare Envi-
  ronmental Defense Fund, 1m-.  v. Ruckel-
  slmus. .in/in,, U2  U.S.App.L).C. at 8G 4M
  F.2d at 5!Mi.                        '   '
    [6]   The  validity of  extrapolation to
  humans from dau derived from lusts on
  animals is ;dso  a mailer within the agen-
  cy's cx|*:rlise.  There was testimony Iw-
  fore  the A significance' of test ani-
  mal dula when cancer JK involved."  Use
  of  animal data is particularly  appropri-
  ate whei-e, as here, accuralo cpidomiolou-
  ii:al studies c.aiiiiot IKJ  conducted Iwcause
  tin; virtually 'universal contamination  of
  humans by  residues of  aldrin/dieldrin "
  make it impossible to eataMiah an uncon-
  tamtnaled  human  control  group.   The
  long-  latency period of carcinogens  fur-
  ther -hinder*  cpidemiulogical   research,
   d the elliical problems  of  conducting
   .nccr ex|K.rimcnl5 on human beings are '
 too obvious  lo require  discussion.  Al-
 though cxlr:i|K>lulion of data from mice
 to men may lx: quantitatively  imprecise,
 it is sufficient to establish  a "substantial
 likelihood"  that harm  will  result.   Cf.
 Society  of  Plastic*  Industry,  Inc.  v
 OSHA.  50(1 F.2,1 1301, at  13(W (2d Cir
 Jan. 31,  K»7.r,).

   Shell  claim* that tests basc:d  on mouse
 data are not sulwtanlial  evidence,  be-
 cause  mouse livers  are unusually suscep-
 tible lo  cancer.   Still, Shell's  data—of
 statistically  significant incidence of  ma-
 lignant  liver tumors—were in strains of
 mice that  were, as  was noted J>y  the
 Administrator,   unusually   resistant   to
 such tumors."   In  any event. Shell's  ol>-
jections are outweighed by the  substan-
 tial  evidence supjxjrting  EPA's  dctermi-

ls-   E S: J.A. 1997 98 (u-slinuiny of Dr.  Up-
  ton);  J.A. 9lfi (testimony of l>r. ilpstun) J A
  903 (testimony of Or. Farbrr).
16.   Environnii-nt;il Defense Fuml. Inc. v.  Ruck-
  elshaus. sii|ir.i. 142 U.S.App.D.C. at 86  n.  41
   10 FJd at 5yu n. 41.
        note .10 Infra and ai-conipanyln«  text.
                                             nation  that  mice arc not uniquely  sus-
                                             ceptible in catxinojrena, but  arc, in fact,
                                             (good predictors of carcinogenic hazard to
                                             man.   Tlio Adminiatnilnr found  that ro-
                                           .  dents arc- particularly useful experimen-
                                             tal unimals.  in part Iwcau.su  of the simi-
                                             larity of their response to carcinogens to
                                             the res|w,r,-.e  nf man, their short lifcspan,
                                             and our relatively well-developed under-
                                             j landing of tin:  imllioio^ical development
                                             of tumors  it: mice and rats.  Respcctetl
                                             nracurch in .!it.iitions such as the National
                                             Cancer  Instil ui.fi Fiavo used  mien exten-
                                             sively " |K:I:;IIIS suspension deci-
 sion:!, for luv-i! "the Hcimiiustnitive proc-
 ess is a c-i.i|iiiitiing one  .   .  .  [that]
 rails for cni.(ii:uing reexauiitmtion at sig-
 nificant junctures."  Environmental De-
 fense Fund, In.-, v. EPA, 5f/pr.-i, 150 U.S.
 App.D.C. at :>.i;i. 4GS F.2.ir«l of 'rnuisp
-------
                                78
    1300
                      510
                              \
          W. 2d SKKIKg

Et  !±E1 i?1""" lh< A"  nnd' the Ad.
                     .
             of major f,,,,

     nogcn in the rat although there"
     cations that this is so."** Tl
     trator thought this caution
     but, after "an  intensive
     flf I ha ***•           " "" "" "*"rHtive of
   AU         n        '"^"ded br the
   ALJ, was WC|,   .
                                                         T°
                                                    u        I"" Ailminb.
                                                   that  an "imminent h«z.
                                     ard  uxmteon the ground  that «ho Ad.
                                     mimstrator failed to establish « causal
                                     connection between the „'*., of
con^r^^tr^   »'rr11^^"" »' U'C'
««- fc-o^ c«P,.incr S.IK   irrjs±r£ sj

                                            Ex. 38C. p. 3.
                                                          ,„
                                   *  A.O.
                                                               M 57.
  :;]
';:M.
                                                                                   • i
                                                                                   • II
                                                                                   . (t
                                                                                 ill

-------
                                                                  ^•—Whiaijuv.<;.-•'  iiiii'iiiiin ••••! '•
                      „. F        :  ENV,IIONMENTAL •
                          Clh-Mai     135(1073)              ^'
                                                                             .   1301
                 for „ n.uch „ 80
   of aldnn u.su,fe  in  1971 »  Other
   pended  use,  may  havc ^^
   much as G percent of aWrin sales u»,l
   aj'pmx.matcly half of the diofclrin u
   Moreover, the PDA Market Basket
                                                                              lainly
 the  human fat  am
the years 1970-1972.1'
                                   lesled
    K1PA'., conclusion that tnc prohibition

      i. IT Tmant 11..H ,,n,|  transported  to
 the aerial parts  of cro|)3> 3uch  m
 bcnns. which  are  rotated  with  corn.
 Jfany of  these  product*  are imjxjrtant
 feed component* for animanls.  The  IXM-
 licide  residues arc thus incorporated, di-
 «jUy and indirectly, into the milk, meal,
poultry, and  soy  products consumed by
numans.                              '
  Shell sees  inconsistency in EPA's  ex-
emption from sust>en.sion of  thu  use of
•oil-ini|4anU.il uldrin/dieldrin as a termi
                            to  the lop
              - ._.., in lands typically sul>
        to  frequent  disturbance  throuel,
   plowing nn,l disking'.
     There is .sulistantiul cvi,
   sufficient  to .iup|Mrl  the
       nl Ie:isl  where,
         in*  failed to come
         huwinjf that no causal
  exists.  Shell  did  not even protest
  evidence on causal connection in  its ar-

  SrAnrr°rthC,AU<  Nor didit cont^
  me ALJ s  finding  of  a  causal  rclat'
  ship in its  objections filed with the Ad."
  mimalnilor  Tim  At p.        .
  .          •  •"«•  *!•*> s  causation  find-
  T? •""''     '"'I'l'wl assumption of
  Administrator's order.  His failure  t,
       it on  the  point yields  no basis
       attack, especially in vicw of
      of objection on this  ground.

 •D.  Minor Uses

   HO)   Shell, FCM  anH  IKSHA   i •
 tlmt i*,*  A   • •         UbDA claim
.tliat the  Administrator  haa  failed  to
 show  evidence  of  the  existence of an
  imminent ha^rd" and a  causal connec-
 ton for each suspended use of aldrin/di-
 cMnn.  They would place  the burden 0
 the  agency  to bring forth  material on
 each  cron ?m^  «O-L  ....     ..  .     '
         Br. a, 8.
                                           v
                                           y the suspension order.  But
                                  •t ia not necessary to have evidence on
                                 t-  i'   'u,a H|1Ccific U!MJ or arcu fn order
                                 to  be able to conclude on the boaw of
                                 •ubrt.nlml evid,nco lhat Ulc  ^ ?[
                                 P|«t,dde] in Keneral is hazardou^  Bn"
                                 vironmental  Defense Fund. Inc. v EPA
                                 TI2 16° U-S-A|'|>.D.C. at 130, 489 P^i
                                 »t 1254.  "Keliance on gunen,!  daU eof
                                "..Icration of IalMniloiy oxpcrimc7u on
                                nnimab ot^» h,us l^n found  to provide
                                • •ufffacni basis for an order  cancelling
                                the  reffwtrution of a pesticide.   Id
                            Be. Ml. J.
     O. 3;  Shell Ex. 111. J.A. 1310.
   ,A.O. 3.

    EPA Ex. S 7. J.A.  MM 64.
                                3IuJJe £n .Sh°W dWdrin rosiduel d«rinB
                                 •n«la24 pp,n.  KPA Ex <7 (Dr. Kulx). .,
                                 1261          9U ** EPA ^  S-IS.
                                                                                                                 I
                                                                                                                  •X
                                                                                                                  -
-------
I
..».'»•
•*•?
..   80
•fc'WHAI._ IIKI'OKTKII. M 'ii. i    •   .
                                    1 "„:"
           turbcd
                          court.
            Compare Shell Br. at 44-43.
                F.2d a, sic
                                                                 „
                                                                              „,
                                                                                    . (I.
                                  Defense  FunU.
            -  E S-. EPA Ex. 71. JA  1121
            •'. '-A. .092..03: tPA K.. «.'

-------
                              -••-•   -.--..•,  .'   • •'  81
                                  •••    -     -'•'.'
                               J*-tli^m  ,.  -"t'li.'.   •. ji.' •       '  ;    ....
                                    -   111 •• i «i »m IM, ^,,v. .j^fcijin^^K^j
      .    KNV1KON.M KNTAI/ D. P., INC. v.
                                  Cite IM Sin K
   We can Imnlly overturn  the  Administra-
   tor's  cnncliision   that  the  alternative
   were nileiiuatc on the ground that IK- did
   not give  tiun|ie(liiiK weight to  conve-
   nience.
     Testimony that  earlMiinato  and  orga-
   nophospalc alternatives do not  share the
   pcnistencn,  lipidsolubility, and  biocon-
   centmtion in  animal or   human  tissues
   characteristic   of   aldrin/dioldrin--ai,.|
   thus do not  pose  the same cancer riak—L
   BiipiiorU  thu finding: that the  aJlcrnur
   lives  are environmentally suitable.
  2.  Minor  Unas

    [16]  USDA  and  PCM  challenge the
  Administrator's failure to provide exten-
  sive riHk.lN!neni analysis   for each  rrop
  and each  geographical  area  for which
  aldrin/dieldrin   has  huun   suspended.
  They fault the order on the grounds thai
  it  makes conclusory findings  for minor
  uses without discussing the contrary ovi-
  'cnce  ami tlmt it lacks substantial  record
  evidence lo support its rationale.  How:
  ever, the expedited nature of the suspen-
  sion proceeding impost*  limitations on
  the de-give of detail  that can be expce'crd
  from the Administrator's findings at this
 stage of the  administrative process.   A
 more careful exploration  of the availabil-
 ity of alternatives for minor uses  would
 be contemplated for the final determina-
 tion on cancellation  «.•/ non, but  we can-
 not demand an  extended   discussion of
 the evidence for every uso at this  emer-
 gency,  provisional .stage.
   The nrcord evidence  a* to the  relative
 risks and In-ncfits of each use in i\ mixed
 baff, but it  provides substantial support
 for the Administrator's conclusion.   The
 order cites California ex|ieriencc-wilh al-
 ternative iRisticidcs that have proved <-f-
 fcctive  against Fuller's Uoxe Beetle,  the
 Florida  citrus  |iesl  conlnilled  by  ald-
 rin/dicldrin,  and  there is  also  evidence
 thnt effective foliar sprays  will  IHI avail-
able for use should  an emergency  arise
during the aus|>cnsion periixl. Morcovt-r,
aldrin/dicldrin is used on less than 5 |>er-
  ENVIUON.MKNTAI. IMcO.'AGCY.
   cent of i hr total  citrus acreage, and  tho
   Al J notitd  that much  of Unit use was a
   kind <.-f "ju.-u in care"  insurance,  appliitl
   even in (In- nlwemv ..f  knowledge thnt
   the  ^-st  ,-xisu» in  tho rx-rtinent grove.
   As  to  yt!|.!(- crops.  Ll»: r.rcord indicates,
   for  CN.-inipl..-, that  ••ff..-.-iivc registered  ai-
   ternalivr.-.,  ;ire available;  that,  in  the
   case of (.;.-,( -apples :i;iil cnmberrius, aid-
   rin/dicl-irin  offer  tmil'.i-year  protection,
   so tho  h«r.rfim of p:,sl  applicsitioiw will
   conlinu-;  am| in!lt  thv pn.-scnt oversu|».
   ply  in  l>n: tranben-y i»:;1fk«;l  diminislics
   thi:  j.r ..-;,,. .-,:(. f,f har-Miip  from thu sus-
   pcn::io»: i:i ivganl  lo i|;:i
  3.  lli:nt:ifhlyr la itn Alternative
    Shell  prot-sf*  lh:,t  l.<-[.Uichlor/ddor-
  dan.-, p.-.-,l.;.-;des  that ili-.iiionstrate <:ard-
  nog..T.i,-i'y in  mice and  are stored in hu-
  man Iks-:.; in  the same levels as  ald-
  rin/
-------
                                             82
'
              1304
                                 aBain
                 to
                                                                  SERIES'
                                              cj.   What impn-wei us about the »
                                              l«n*on order  umU-r review  is UH,
                                             ' n"»'8tralf« «n»il,lc effort to
                                              "Pinion  lh!ll cm,,l,:usi«,|

                                              £" .•*«",*«* Inmos «„<*
                                              Pnrt,o^,ircinou,nici    And hi*

                                              » o» and f.ndin^ on tho other
                                              matter,  ,s adcuntc  to wtfefv
            his opin^Ll™ru± 1 W?^l°^UO   m"tlCr" iH a'Hu«t«  to M*
            of U.e 3tntul,ly p,^ejn"tmi";:-''art-  'TC"Urt ««* '»« .1-cW-n v
            -"ch^ -^^JiS-S-J-   -1"-"^ - -Pri^y.
                                                                                        c.x-
                                                                          s
                                            jcct-on that  the 'Administrative

                                            "onrC\n?KrCquirca ri"'linjn of thc
                                             on all the material ;«,„«,- and
                                                                                    lhc ol»-
                  sir l» '--c- safd explicitly
                                                                                   indeed
                                   of
                                 -*
                        «"l'«nt Broun*  of objcc-
         pension
                preclu,lc
             .t-   •
             think ,t ,ufnci«nl  lh«
                . 0,id,n« in
             »urt is
                 th.
                                                to thc extent of vacating thc
                                               or rcmandinjj for further fin
                                                  thi, was not
                                                                               the
                                          B.  Procedural Challenges

                                            [19J  We  turn,  finally
                                          most anlcntly  prcss,:d |,y
                                          mcnt, am) aclnptal hy the n
                                      I-  era,  that the EPA Order i, Ulin

                                         2I£i«'»"«"fc.liumi in  that memtK-r,
                                         of the agency's cnforc,ment ,taff.  who
39.  A.O.  I.







 oe redeemed by resort  to a detailed faauaj
                                                            B€Wt0n T*lev«'<"« Corp. v. FCC
                                                  l-m            ' -- -
                                                  (19.0). ei-rt. «(«ifctl.  403  US.  9-»3  QI
                                                  2233. 20 UW.2d 701 (197.)

                                                  -  Shell R. Dr. .t i

-------
                                                    83
                                               (.4 ill
        KNVIKONMKimi, J). F., INC. v.
                                 Cltu an 310 K
 were involved in the continuing cancella-
 tion hearing aL the time. presented arjfu-
 menu* to UK- Administrator favoring the
 issuance  of a  Notice of  Intent  to  Sus-
 |N!iitl.   Shell  concedes that  eoimnunicu-
 lions between  the prosectiloriaJ  and ad-
 juilicativu staff of an agency arc appro*
 printo prior  to the  initial  filing  of nn
 administrative   complaint,  hut   argues
 that this rule docs  nol apply  whero, as
 here,  the  comrminications  Uiko  place
 while another pli;ise of the "same case"
 w underway.  We reject  Shell's  conten-
 tion.
   Suspension  and  cancellation  hearings
 are separate  proceedings  in  the  respect,
 criticul  here,  that the  decisions  in  the
 two proceedings arc mad« under differ-
 ent legal  standards."  To the ex lent  that
 they are  related, we do not  find  I his to
 lie d bar  to the kind of communications
 engaged  in here.   It may  hap|icn that
 during the  course  of an agi-ncy proceed-
 ing against two  individuals  the  "proso-
 :uting" staff  discerns from  the evidence
 that proceedings should also IK: institut-
 ed  against, or the  initial  proceeding
 broadened to  include, a third  individual.
 The proseculorial.staff would  not be de-
 barred from consulting with the  agency
 head about  these steps  by the mere fact
 that a related  proceeding wiis already
 under way.   The same conclusion is  ap-
 plicable  whore,  there  is no new party  but
 the  emerging evidence indicates  that a
 new charge  or a broadened charge is  ap-
 propriate.

   Congress  ha.i  not accepted the  view
 that  the  |Kis.sil>ililios of  unfairness  re-
 43.  Scf  Environmental Defense Fund.  Inc. v.
   KPA. supra. 150 U.S.App.D.C.  ui .157.  4G3
   F.2U at  537;  Kiwiroiimcnlal  Defense  Fundj
   Inc. v. Ruckelshnu.i. supra.  142  U.S.App.D.C.
   HI  81. 439 K.2d at 591.

44. This view was proposed by Messrs. Me Far-
  land. Stasoii and Vanderbilt. in their addiiion-
  •I views that accompanied the  Report of  the
  Attorney General'* Committee on Administra-
  tive Procedure.   Sec  Administrative  Proce-
  dure In Government Agencies. Sen. Doc.  No.
  8. 77th  Cong.. 1st Stss. 203 (1941).
 ,  The only agency for. which  this view was
 made a  legal requirement  is the National  La-
 •tor Relations Board.
    110 F.Jtf—«JV>
 <:;u\ vx-
. i<  ;t new
..|i;njion
:,ii... i  of
 KNVIKONMKNTAI. PHO. ,\fiCY.  13Q5
:u j;ie (i975>
  quire  prohibition  of an ndniinislnilivc
  structure  that permits the  j:»n«.« agency
  U> issue the notic-e  that begins a  prix^ed-
  ing and to make lh- uluusai.- iVicrwinu-
  tion."  It has acooptod a pr.'iginatic view
  that the need for ••ffcctivc cy  the
  agency head ovi-r  tnc comm- -nccincnl of
  proceedings  r-^uirt: an a'r.Jity  tw con-
  duct consultations  in candor witJi nn  in-
  vestigative   section  on  {]-.•:    ifiestion
  whether A  notict nhnuld  I.-.-  i.^ucil and a
  proceeding begun, .v-.d thi^ noi-^iilirfiand-
  ing any  residual  [--i.sibilitii-s of  unfair-
  ncss.
   In this cas»» llio  :t|»i«r.cy  rirsn-.irii.v.'  the
 inlernnl suparation m uincii-.iii.i j.-nivirkil
 by Congross in its  eon;:»i:i:-.ii;-n  of  f.-\ir-
 n<::«i and pragma ti.-:n;  th<-i-.. iy  I1(J
 of  consultation  li*>'.wuv:i  :h(-  ai'
 "prosecutors" ami  '.hu  ug'.-nvy  ^<:;
 ccpt on the issue \vheMi- ••• u. :.-.>.
 notice — whether  to.  ntart  ;•. .-'
 proceeding.   Then: is  no  .- pli-j:
 communication   Ix-'.wcvn   "pi-;-M'<-i;iHr"
 and agency hum I rii::ir»!ini:  IMC.-  "\::^\ de-
 cision in either the canco!!;^;. ;i  procwd-
 ing or the suspension priK.-^.!!!;^."
   The  Adminialr.-itor's i'ndicuMoro in the
 Notice that  he is "ix:rsya!c atiw.r----  effects'
 on man and  the environmi-::'." " do not
 represent projudgnv-nt  o.' \ho ::-..:riL<  of
 the  decision  to su-;vnd.   Ti-.--  Adminis-
 trator w»is merely  makini: ;• •'•-.v-rir.ir.a-
 tion to begin a sus|- ruion |.HH. . .!in^» un-
 der § C(c)(l) of FII-V.A," :uv  ..n-.iniL.I  by
 45. The  Adniinistr:il:Vf  Pn^;t-,|.ir.-   At!   S
  U.S.C. 5 5W(d) (1970!. o.-.Jy p-..;,,' as
  luition  or advice  ii,  the  "d.vtsi.-,!,.
  mendcrl decision, or  ,:s«ncy r.-vu-w.-
46, Notice of  Imtnli'.Ni to  .Sus;vnil.  J.A.  70.
47. 7  U.S.C  $  niMi;c)(l) (Su!>n.  II. 1972).
  Section  6(cXD  pru^Jes  thai  .1 "r.oiic*  (of
  intent to  suspemJ) sluU incliiii-.- lin('in^,s )>vr-
  lainlne to the mn-stion of >imnn:ifiu n.izjrd.' "
    Compare FTC v. Cinderella Career  and Fin-
  ishing  Schools,  Inc..  131 U.$.App.UC, ^31.
  338, 404 FJd I3U8.  1313 (l?tvS). whore this
  court held that the  FTC could  isme » press-
  release  stating that it  found "reason to be-
  lieve"  the law had h«rn  viula'.itl soon after
  the Issuance of a complaint.
                       : ;
                  '.:.:!•
                 fl:
• i.
 ! :
                 '•!'[•
                ;ii!i
                                                                                             • iCi:
                                                                                             1 I'-
                                                                                              ll'!''
                -<*.
               .$.

-------
  '»;
.VIP
 m
-A
                                 S10 PKnKKAI. lll-1'OKTER, 2,|
 lho  prefatory  finding required  hy tht.
 law. without prejudice in Iin.v way In in,.
 consideration that would I*'riven U> ih..
 •llatu».a:n_ _„„   ,    .       «••»•» 1111.
     •won record and  l<» the result that
       bo reached in  lhu  Ijtfu Of lhnl
         Tho  prominent*  of  conlinuwl
a* 4S£T •*•"'" *•«*«"
 «^S!»',hk°s.u,T.Mi>>°  l"!"i»e
   Shell  wiw  alh,ilo,l  12  »f th«  15
             ror ihe w^liM
            ,t ,,.v,| on|y 8^ nf
     iya. and ,li,| ,mt tflkc ndv.-.ntnR,. of AU
   I orlmnn'., offer lo ,x.Tmit the prc^nta-
   t.on  W,th,,,,i cro^xn.uin.aion  of the
   wntlun  Hlutc,nc,,u,  of   witncssca  that
   eoW not !« heard orally within lhc al-
         Uine.
                          r
                        "f uranscri|)l       re  »
                        exhibit,  from the cancolh-
                                            cnua.
                         .ntcresla in  that the EPA
            prosecutonaJ  staff  and EOF

                                in
                  in  the  cancellation  proceeding.'*
           Shell did not n,akc « s|,owinff that *
           shortness of the duration of the suspen!
           s.on heanntr precluded a fair dhporfL.
           or that more time would have been nee.1.
                               -c
               ,         a presentation in favor of
          contmued registration.  Indeed, although
  C.  Kxun>i>tiitn df
    120)  RDp ehaiwa|  lhat lhc
  eiaion lo exempt the sal,, „,„, „„. „,
  wlmic stocks ,,f aldrin/dii-l Irin from  lho
  Kenerai  suspension  i,  arbitrary and
  pncious.  EPA  ,ms res^Mulcd -
  •Iccision  was  based „„ „„  B	
  wat no  ap|ir,*ial,lc and rnalwtienllj
  ncvable st.xrks existed «t  lhe  t
  the artier, and that any denial of
 dural ririiLs u-a.s harmless error
 counsel have informed  us lhat EPA
 prrsenlcd in January  1975  with
 mules  lhat 'ii      '
 the loui  107-1 nmoilnt of aMri^"^
 will l>e available for usc in ,Q-c
 ••  • p>DA •     t              "»IO,
     t-fA intends to invcstijratc the
     further, an  onj^oinp
     is  entirely appropriate.

  rWorafn  7", l'1C  '^"^ susl^n«ion or.
  r of  October I. 1974, except for the
exemption of the sale and usc of exi
stocks.  The record  is remanded '"
Ibcr considonition of  that issue.
  ti.% — _.l	i
            were used
                              NWICP
                                 M °f the IS d«>''
                  <*
                                                                                                  t&''v •••*:$
                                                                                      1
                                                                                        'I
                                                                                                   !*•
                                                                                       .1
                                                                                      . • I
                                                             and ihe user group,, is.
                                   3,-
                                                                                                          II;

-------
r
      IBLIOGRAPHIC DATA
      HEET
. Report No.
 EPA-44Q/9-76-QQ8
3. Recipient's Accession No.
     4. Tide and Subtitle

            Criteria Documents for Aldrin/Dieldrin
                                                  5. Report Date
                                                   June 1,  1976
                                                                            6.
     7. Author(s)
            Anonymous
                                                 8. Performing Organization Kept.
                                                   No.
    9. Performing Organization Name and Address
            U.  S.  Environmental Protection Agency
            Office of Water Planning and Standards
            401 M Street,  S.W.
            Washington, D.C.   20460
                                                 10. Project/Task/Work Unit No.
                                                 11. Contract/Grant No.
     12. Sponsoring Organization Name aod Address
            Office of Water and Standards
            U.  S.  Environmental Protection Agency
            401 M Street,  S.W.
            Washington.  D. f.  20460	
                                                 13. Type of Report & Period
                                                    Covered
                                                   Interim
                                                 14.
     15. Supplementary Notes
     16. Abstracts
            This document  summarizes  the physical/chemical properties,  toxicological
            information and environmental fate and effects of Aldrin/Dieldrin, with
            emphasis on aquatic behavior.  From these  data, criteria are developed for
            the protection of aquatic life and for human exposure.
    17. Key Words and Document Analysis.  17a. Descriptors
            Criteria
            Toxicity
            Aquatic animals
            Aquatic biology
            Human ecology
            Safety  factor
    17b. Identifiers/Open-Ended Terms

           Toxic Pollutant Effluent Standards
          Federal Water Pollution Control Act
     7c. COSATI Field/Group

    18. Availability Statement
           Release unlimited
                                     19.. Security Class (This
                                       Report)
                                     	UNCLASSIFIED
                                                                20. Security Class (This
                                                                  Page
                                                                	UNCLASSIFIED
                                                                                      21. No. of Pages
                                                           22. Price
         NTis-38 tnev. 10-731  ENDORSED BY ANSI AND UNESCO.
                                                         THIS FORM MAY BE REPRODUCED
                                                                                      USCOMM-OC B298-P74

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       (e.g., date of issue, date of approval, date of preparation, date published).


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      from the performing organization.

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      proper  authorized terms that identify the major concept of the research and are sufficiently specific and precise to be used
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rORM~NT1S-39~(RSV. 10-73)                                                         "                        USCOMM-OC 8283-P74

-------