IITOVIATIOI
Lindane Position  Document 2/3

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                             Acknowledgements
PROJECT TEAM
Richard Bright, Project Manager, SPRD
William Bumam, Pharmacologist, HED
Carroll Collier, Chemist, HED
Christine Chaisson, Toxicologist, HED
David Dellarco, Student Assistant, SPRD
Julian Donoso, Chemist, HED
Mark Dow, Entomologist, BFSD
Donald Eckerman, Economist, BFSD
Karen Flagstad, Writer/Editor, SPRD
Cara Jablon, Attorney, OGC
Janice Jensen, Chemist, HED
John Leitzke, Biologist, HED
David Severn, Chemist, HED
Gregory A. Thies, Project Manager, SPRD
Richard Troast, Senior Project Manager, SPRD
EPA PESTICIDE CHEMICAL REVIEW COMMITTEE  fPCRC)
Charles Gregg, OWWM
Richard N. Hill, OPTS
Allen L. Jennings, 0PM
Donna R. Xuroda, ORD
John J. Neylan, OE
Edward Tuark, OANR
Marcia Williams, Chairperson, SPRD, OPP
Michael Winer, OGC

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                            Table of Contents

I.   BACKGROUND                                                              1-1

     A.   Introduction                          .                             1-1

          1.   Chemical and Physical Characteristics                         1-1
          2.   Registered Uses and Production                                1-1
          3.   Tolerances                                                    1-2

     B.   Applicable Sections of FTFUA                                       1-2

     C.   The "RPAR" Process                                                 1-3

     D.   Regulatory History                                                 1-3

     E.   Bases for the Rebuttable Presumption                               1-4

     F.   Legislative Background                                             1-4

II.  ANALYSIS OF REBUTTALS AND ASSESSMENT  OF  RISK                           II-1

     A.   Rebuttal Analysis                                                  II-1

          1.   Attempts to Rebut the Presumption of Oncogenicity            II-1

               a.   Attempted Rebuttal  Pertaining to  Dosages Used in
                    Testing                                                  II-3*
               b.   Attempted Rebuttal  Pertaining to  Liver Toxicity as a
                    Test  Interference                                        II-5
               c.   Additional Studies  Submitted in Attempted Rebuttal      II-5
               d.   Coinaents Submitted  on  the National Cancer Institute
                    (NCI) Carcinogenicity  Bioassay                          II-6

          2.   Attempts to Rebut the Presumption of Reproductive and
               Fetotoxic  Effects                                             II-6
                                            ^
               a.   Attempted Rebuttals Pertaining to Naishtsin and
                    Leibovich  (1971)                                         II-9
               b.   Attempted Rebuttal  Pertaining to  Petrescu at al.
                    (1974)                                                   II-9
               c.   Attempted Rebuttals Pertaining to Earl er al. (1973)    II-9
               d.   Attempted Rebuttals Pertaining to Exposure:
                    Fetotoxicity                                             11-10
               e.   Additional  Studies  Submitted in Attempted Rebuttal      11-11
               f.   Additional  Agency  Findings  Concerning the Presumption
                    of  Reproductive  and Fetotoxic Effects                   11-11

          3.   Comments Submitted  on  the Presumption  of Acute Toxicity to
               Wildlife:   Aquatic  Organisms                                 11-16

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    4.    Comments Submitted and Agency Findings on Possible
         Adverse Effects                                              II  17

         a.    Comments Submitted on Possible Adverse Effects:
              Mutagenicity                                            II-18
         b.    Ccnments Submitted and Additional Agency Findings on
              Possible Adverse Effects:  Blood Dyscrasias             11-18
         c-    Comments Submitted and Agency Findings on Possible
              Adverse Effects:  Acute Hazards to Humans and Domestic
              Animals                                                 11-22

              (1)  Acute Hazards:   Studies Submitted on Inhalation
                   Toxicity                                           11-23
              (2)  Acute Hazards:   Studies Submitted on Dermal
                   Toxicity                         .                  11-24
              (3)  Acute Hazards:   Studies Submitted on Oral and
                   Intraperitoneal Toxicity                           11-24
              (4)  Acute Hazards:   Additional Agency Findings
                   Concerning Central Nervous System Stimulation      11-25

              (5)  Increased Susceptibility of Children to Lindane
                   Poisoning                                          11-25

         d.    Comments Submitted on Possible Adverse Effects:
              Population Reduction in Nontarget Avian Species         11-31
         e-    Comments Submitted and Additional Agency Findings
              on Isomerization                                        11-32

              (1)  Chemical Driving Forces                            11-33
              (2)  Isomerization in the Environment                   11-33
              (3)  Isomerization in Plants                            11-36
              (4)  Isomerization in Pats                              11-36

B.  Exposure Analysis                                                 11-38

    1.    Persistence and Exposure                                     11-33

    2-    Comments Submitted on Exposure                               11-39

         a-    Comments Submitted on Dietary Exposure                  11-39
         b.    Comments Submitted on Exposure via Drinking Water   .    11-39
         c.    General Comments Submitted on Exposure via Air Intake   11-41
         d-    General Comments Submitted on Exposure via Accumulation
              in Human Adipose Tissue                                 11-41
         e.    General Comments Submitted on Work-Place Exposure       11-59

    3.    Dietary Exposure:  Agency Determinations                     11-59
                             111

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     4.
     Applicator and Honeowner/Householder/Occupant Exposure:
     Agency Determinations
                                                                        11-59
          a.
          b.
          c.
          d.
          h.
          i.
          J-

          k.
          1.
          m.
          n.
          Applicator Exposure:
          Applicator Exposure:
          Applicator Exposure:
          Applicator and Homeowner
          Exposure:
          Applicator Exposure:
          Applicator Exposure:
          Applicator Exposure:
          Applicator Exposure:
          Applicator Exposure:
          Applicator and Occupant
          Exposure:
          Applicator Exposure:
          Applicator and House-
          holder Exposure:
          (1)   Pet Anti-Flea Collars
          (2)   Dog Wash (Veterinary Use)
          (3 )   Dog Shampoo
          (4)   Dog Dust

          Applicator Exposure:
Hardwood Logs and Lumber
Seed Treatment
Avocados

Ornamentals
Cucurbits
Christmas Trees
Pecan Orchards
Forestry
Livestock

Structures
Pineapples

Pets
                                             Household Uses
               (1)  Shelf Paper
               (2)  Floor Wax
               (3)  General Purpose Household  Spray
               (4)  Smoke-Fumigation Devices
          Applicator Exposure:
                                             Minor  Uses
C.
          (1)  Moth Spray (Aerosol) - Industrial Use
          (2)  Insect Spray - Uninhabited Buildings
          (3)  Empty Storage Bin Fog Spray

5.   Total Body Dose Calculations

Risk Assessment

1.   Risk:  Carcinogenicity
2.   Risk:  Fetotoxic Effects
3.   Risk:  Acute and Subacute Central Nervous  System  Effects
II-6
II-6
11-61
I
II-61
11-61
11-61
11-62
11-62
11-62

11-63
11-63

11-63
11-63
11-64
11-64
11-64

11-65

11-65
11-65
II -<•
II-

11-67

11-67
11-67
11-67

11-67

11-72

11-72
11-73
11-77

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III. BENEFIT ANALYSIS

A.   Introduction                                                           III-1
B.   Underlying Assumptions and Limitations                                 III-1
C.   Hardwood Logs and Lumber                                               III-6

     1.   Usage                                                             III-6
     2.   Alternative Methods of Control                                    III-6
     3.   Economic Impacts                                                  III-9

D.   Seed Treatment (Small Grains and Corn)                                 III-8

     1.   Usage                                                             III-8
     2.   Alternative Methods of Control                                    111-12
     3.   Economic Impacts                                                  III-14

E.   Avocados                                                               III-16

     1.   Usage                                                             III-16
     2.   Alternative Methods of Control                                    111-16
     3.   Economic Impacts                                                  111-17

F.   Ornamentals                                                            111-17

     1.   Usage                                                             111-17
     2.   Alternative Methods of Control                                    III-18
     3.   Economic Impacts                                                  III-18

G.   Cucurbits                                                              III-18

     1.   Usage                                                             III-18
     2.   Alternative Methods of Control                                    111-18
     3.   Economic Impacts                                                  111-21

H.   Christmas Trees                                                        111-24

     1.   Usage                                                             111-24
     2.   Alternative Methods of Control                                    111-24
     3.   Economic Impacts                                                  111-24

I'.   Pecans                                                                 111-24

     1.   Usage                                                         .    111-24
     2.   Alternative Methods of Control                                    III-25
     3.   Economic Impacts                                                  III-2S

J.   Forestry                                                               111-29

     1.   Usage                                                             111-29
     2.   Alternative Methods of Control                                    II1-29
     3.   Economic Impacts                                                  111-30

          a.   Commercial  Forests                                           111-30
          b.   Seed Orchards  and Gun Naval  Stores                           111-30

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     Livestock
                                                                 111-31
     1.    Usage
     2.    Alternative Methods of Control
     3.    Economic Impacts

L.   Existing Structures

     1.    The Nature of Powder Post Beetle Infestation
     2.    Usage
     3.    Alternative Methods of Control
     4.    Economic Impacts

M.   Hawaiian Pineapples

     1.    Usage
     2.    Alternative Methods of Control
     3.    Economic Impacts

N.   Pets

     1.    Usage
     2.    Alternative Methods of Control
     3.    Economic Impacts

0.   Household Uses

     1.    Usage
     2.    Alternative Methods of Control
     3.    Economic Impacts

P.   Minor Uses

IV.  Risk/Benefit Analysis:  Development of  Regulatory  Options
     A.
     3.
Introduction
Salient Risk/Benefit Considerations

1.    Salient Risk Factors
2.    Salient Benefit Considerations
     C.   Development of  Regulatory  Options

          1.   General  (Non-Use-Specific) Measures

               a.   Require Label Warnings for  All  Uses  of  Lindane

               b.   Classify  Lindane  for Restricted Use  and Require
                    Applicator  Certification
                                                                 111-31.
                                                                 III-3I
                                                                 111-32

                                                                 111-32

                                                                 111-34
                                                                 111-34
                                                                 111-34
                                                                 111-35

                                                                 111-35

                                                                 111-35
                                                                 111-36
                                                                 111-36

                                                                 111-36

                                                                 111-36
                                                                 111-36
                                                                 111-37

                                                                 111-37
                                                                 III-3
                                                                 III-3
                                                                 111-37
111-38

IV-1

IV-1
IV-1

IV-1
IV-4

IV-5

IV-12

IV-12


IV-12

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          2.   Use-Specific Measures                                        IV-13

               a.   Hardwood Logs and Lumber                                IV-13
               b.   Seed Treatment                                          IV-19
               c.   Avocados                                                IV-19
               d.   Ornamentals    •                                         IV-20
               e.   Cucurbits                                               IV-21
               f.   Christmas Trees and Forestry                            IV-21
               g.   Livestock                                               IV-22
               h.   Structures                                              IV-22
               i.   Pineapples                                              IV-23
               j.   Pet Uses                                                IV-23
               k.   Household Uses                                          IV-24
               1.   Minor Uses                                              IV-24

V.   PROPOSED REGULATORY DECISION                                            V-1

     A.   Risk/Benefit Analysis of Regulatory Options, Use by Use            V-1

          1.   Hardwood Logs and Lumber                                      V-1
          2.   Seed Treatments                                               V-3
          3.   Avocados                                                      V-5
          4.   Ornamentals                                                   V-6
          5.   Cucurbits                                                     V-8
          6.   Christmas Trees                                               V-9
          7.   Pecans                                                        V-10
          8.   Forestry                                                      V-11
          9.   Livestock                                                     V-12
          10.  Structures                                                    V-13
          11.  Pineapples                                                    V-14
          12.  Pets                                                          V-16

               a.   Dog Washes                                               V-16
               b.   Flea Collars, Dog Dusts, and  Dog  Shampoos                V-17

          13.  Household Uses                                                V-1S

               a.   Shelf Paper                                              V-18
               b.   Floor Wax                                                V-18
               c.   General Purpose Household Spray                          V-18
               d.   Smoke Fumigation Devices                                 V-18

          14.  Minor Uses                                                    V-19

               a.   Minor Uses  Specifically Under Review                    V-19

                    1)   Industrial Use Moth Spray                          V-19
                    2)   Uninhabited Building Insect  Spray                   V-19
                    3)   Empty  Storage Bin  Fog  Spray                         V-19

               b.   Other Minor Uses                                         V-20

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B.   Summary of Proposed Regulatory Decision                            V-20

     1.    Hardwood Logs and Lumber                                      V-20
     2.    Seed Treatment                                                V-211
     3.    Avocados                                                      V-21
     4.    Ornamentals                                                   V-21
     5.    Cucurbits                                                     V-21
     6.    Christmas Trees                                               V-21
     7.    Pecans                                                        V-21
     8.    Forestry                                                      V-21
     9.    Livestock                                                     V-21
     10.  Structures                                                    V-21
     11.  Pineapples                                                    V-22
     12.  Pets "                                                        V-22

          a.   Dog Washes                                               V-22
          b.   Flea Collars, Dog Dusts/ and Dog Shampoos                V-22

     13.  Household Uses                                                V-22
     14.  Minor Uses                                                    V-22
                             VI11

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               List of Tables
Table II-1.


Table II-2.


Table II-3.


Table II-4.


Table II-5.


Table II-6.

Table IIV7.

Table II-8.

Table II-9.

Table 11-10.

Table 11-11.

Table III-1.

Table III-2.


Table III-3.


Table III-4.

Table III-5.

Table III-6.


Table III-7.
Comparison of Oncogenicity Studies  Cited  in  the Lindane RPAR
Notice and the NCI Study in Mice.                             II-2

Summary of Studies Cited as Bases  for  the Presumption of
Reproductive and Fetotoxic Effects.                           II-3

Studies Submitted in Attempt to  Rebut  the Presumptions of
Reproductive and Fetotoxic Effects.                           11-12

Summary of Studies Submitted on  Lindane as a Possible
Mutagen                                                       11-19

Acute Effects:  Summary of Human and Animal  Studies  on
Lindane as a Central Nervous System Stimulant                11-26

Average Lindane Residues in Food (by Composite  Category)     11-40

Exposure Data:  Summary of Application Practices,  Use by Use 11-42

Exposure Data:  Summary of Exposure Analysis, Use  by Use     11-43

Estimated Applicator Exposure, Present Use Practices         11-68

Total Body Doses (Applicators),  Present Use  Practices        11-70

Summary Assessment of  Applicator Risk, Present  Use Practices 11-74

Summary of Benefit Analysis                                   III-2

Use  (in Pounds) of Fortified BHC and Gamma Iscmer  to Treat
Green Hardwood Lumber  -  1975                                  III-7

Expected Values ($) With and Without Chemical Pest Control
of Hardwood Lumber Per 1,000 Board  Feet                       III-9

Estimated Lumber Treated by Region  in  U.S. - 1975.           111-10

Economic Dollar Impacts on the Sawmill Industry              111-11

Estimated Annual Use of Lindane  as  a Seed Treatment, by Crop
-  1976.                                                       111-13

Summary of Annual Costs for States  Requesting Use  of Lindane
on Ornamentals (in  1,000 Units)                               111-19
                     IX

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Table III-8.   Total Lindane-Treated  Cucurbit  Acreage,  in Pounds A.I. and
               Cost, 1976 -  1977.                                            111-20

Table III-9.   Treatment of  Cost of Lindane  and Alternatives for Control of
               Squash Vine Borers  and Pickleworm on Cucumbers and Squash in
               Southeastern  U.S.                                             111-22

Table 111-10.  Estimated Total Change in  Cost  of Production and Revenue to
               Growers in Florida, Georgia,  and South Carolina - 1976 -
               1977.                                                         111-23
                                                                                   *
Table 111-11.  Number of Pecan Trees,  Lindane  Treated Pecan Trees,  and
               Amount of Lindane Used,  Selected States  (Estimates for 1978) 111-26
                                                                                   i
Table 111-12.  Treatment Costs of  Various  Insecticide for Control of Pecan
               Phylloxera in the Southeastern  U.S.  (Estimated for 1978}     111-27

Table 111-13.  Annual Treatment Cost  with  Lindane Compared to Alternative
               Control Measures on Pecans, Selected States, for 1976.       111-28

Table 111-14.  Quantity of Lindane Used by U.S.   Farmers  on Livestock in
               1964, 1966, 1971, and  1976  (USDA)                            111-32

Table III-15.  Quantity of Lindane Versus  Alternative Pesticides Used by
               U.S. Farmers  on Livestock  in  1964, 1966,  1971, and 1976.     111-33

Table rv-1.    List of Protective  Measures Considered,  Use by Use           IV-6

Table IV-2.    Impacts of Protective  Measures  on Total  Body Doses to
               Applicators                                                   IV-10

Table IV-3.    Impacts of Protective  Measures  on Applicator Risk            IV-14

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                     LINDANE:  POSITION DOCUMENT 2/3

I.   BACKGROUND

     A.   Introduction

          1.   Chemical and Physical Characteristics

               Lindane is the gamma isomer of the insecticide  1,2,3,4,5,6-
benzene hexachloride (BHC).  Technical lindane contains at  least 99 percent
gamma-3HC, the remaining 1 percent consisting of other BHC  isomers
(Meister, 1978).  Its melting point is 112.8 C.  Its  density is  1.85.
Its vapor press-ore is 3 X 10   mm Hg at 20 C.  Lindane is soluble in
various solvents, and its solubility in water varies  with temperature  (10
ppm at 20 C).  Lindane is stable to light, heat, air, carbon dioxide,  and
strong acids, but is unstable in the presence of alkali (Blaquiere et  al.,
1972).

          2.   Registered Uses and Production

               Environmental Protection Agency (EPA or "the Agency")
records show registrations for about 700 lindane products (270 registrants)
and about 85 federally recognized intrastate registrations  of  state-
registered products.  During the BHC RPAR ("rebuttable presumption against
registration and reregistration") proceedings, registrants  of  BHC and  BHC/
lindane products were allowed to change their registrations to lindane to
avoid cancellation.  All BHC registrations were either voluntarily
cancelled or amended to become lindane registrations.

               Current registrations of lindane products reflect a wide
range of uses.  The major use categories are hardwood logs  and lumber, seed
treatment of small grains and corn, and livestock, but lindane is also used
on Florida avocados, ornamental plants, cucurbits, Christmas trees, pecan
orchards, commercial forests, existing structures (mainly homes), Hawaiian
pineapples, pets and their premises, household pests, etc.  .Lindane pro-
ducts are formulated as wettable powders, emulsifiable concentrates, oil-
base sprays, dusts, granules, and pressurized products, including "one
shot" vaporizers, aerosols, and smoke products (Meister, 1978).

               Hooker Chemicals and Plastics Corporation of Niagara Falls,
New York, has been the sole domestic manufacturer of  lindane.  In May  .T976,
however, Hooker halted production of lindane pending  completion  of 2PA's
review of the chemical, and is currently importing lindane  to  supply its
customers (EPA  1978f).  For the years 1972 through 1976, Hooker  manufac-
tured a total of 3,684,000 pounds of lindane and a total of 4,914,900
pounds of the related compound fortified BHC (FBHC),  which  contains 42-43
percent gamma isomer, for a combined total of 3,598,900 pounds of ganana-3HC
isomer.  Hooker's records show a pattern of declining production during
those five years.  In 1972, 308,000 pounds of lindane and 1,621,960 pounds
                                    1-1

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of FBHC were manufactured, for a combined total of  2,429,960  pounds.   In
1976, the comparable figures were 702,000 pounds of  lindane and 196,080
pounds of BHC, for a combined total of 898,080 pounds.—

          3.   Tolerances

               Tolerances for residues of lindane in or on raw  agricultural
commodities are listed in 40 CFR 180.133 as follows:  7 parts per  million
(ppm) in or on the fat of meat from cattle, goats, horses, and  sheep;  4  ppm
in or on the fat of meat from hogs; 3 ppm in or on cucumbers, lettuce,
melons, mushrooms, pumpkins, squash, summer squash,  and tomatoes;  1 ppm  in
or on apples, apricots, asparagus, avocados, broccoli,  brussals sprouts,
cabbage, cauliflower, celery, cherries, collards, eggplants,  grapes,
guavas, kale, kohlrabi, mangoes, mustard greens, nectarines,  okra, onions
(dry bulb only), peaches, pears, peppers, pineapples, plums (fresh prunes),
quinces, spinach, strawberries, and Swiss chard; and 0.01 ppm (negligible
residue) in or on pecans.

     3.   Applicable Sections of FIFRA

          Section 12(a)(1)(A) of the Federal Insecticide, Fungicide,  and
Rodenticide Act (7 U.S.C. 136 et seq.) prohibits the sale or  distribution
of pesticide products which are not registered by the SPA Administrator,
and section 3 of the Act sets forth the registration procedures.   Before a
pesticide may be registered, however, the Administrator must  determine that
its use will not result in "unreasonable adverse effects on the environ-
ment," defined in Section 2(bb) of FIFRA as "any unreasonable risk to man
or the environment, taking into account the economic, social, and  environ-
mental costs and benefits of the use of any pesticide."

          In other words, any decision on pesticide  registration must take
into account both the risks and the benefits associated with  the
pesticide's use.

          Under Section 6(b) of FIFKA the Administrator may issue  a  notice
of intent to cancel the registration of a pesticide  or  to change its
classification if it appears that the pesticide or  its  labeling "does not
comply with the provisions of  [FIF11A] or, when used  in  accordance  with
widespread and commonly recognized practice, generally  causes unreasonable
adverse effects on the environment."  Thus, the Administrator may  cancel
J/  During those  same years, Hooker  exported  declining amounts  of lindane
    (232,120 pounds in  1972; 32,300  pounds  in 1976)  and F3HC (1,456,320
    pounds in  1972; 47,480 pounds  in 1976).   According to  USDA,  declining
    amounts of  lindane  were  imported to  the U.S.  during the  years 1972-
    1974  (132,939 pounds  in  1972,  5,757  pounds  in 1973,  and  3,525 pounds
    in  1974).   No lindane was  imported in  1975  or 1976.  Mo  ?3EC was
    imcorted 1972-1975.
                                     1-2

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the registration of a pesticide that no longer  satisfies  the  statutory
standard for registration; this standard requires,  among  other things, that
the pesticide "perform its intended function without  unreasonable adverse
effects on the environment"  [FIFRA 3(c)(5)(C)].  The  Administrator may also
change the classification of any use of a pesticide if  he determines that
such a change "is necessary to prevent unreasonable adverse effects on the
environment" [FIFRA 3(d)(2)].

     C.   The ."RPAR" Process

          To implement its authorized functions, the  Agency has designed
the Rebuttable Presumption Against Registration  (RPAR)  process, which
involves gathering data on the risks and benefits associated  with the uses
of suspect pesticides.  By allowing all interested  parties to participate
by submitting information, the process enables  SPA  to make balanced
decisions concerning problem pesticides.

          The RPAR process is set forth in 40 CFR 162.11,  which describes
various risk criteria and provides that an RPAR shall arise if the Agency
determines that any of these criteria has been  met.

          Once a rebuttable presumption has arisen, registrants,  appli-
cants , and interested persons may submit evidence in  rebuttal,  or in sup-
port, of the presumption.  These parties may also submit  evidence on the
economic, social, and environmental benefits of  any use of the pesticide.
If the presumptions of risk are not rebutted, the evidence pertaining to
benefits must be evaluated and considered together  with the evidence
pertaining to risk.  Various risk-reduction measures  and  their costs are
analyzed.  The Agency then determines whether the pesticide may be regu-
lated so that a balance is achieved between risks and benefits.  If the
statutory balance cannot be reached for any given use,  the registrations
for that use must be cancelled.

     0.   Regulatory History

          Pesticides containing lindane have been federally registered
since the early 1950*s.  A summary of regulatory actions  on lindane through
1975 is given in Lindane;  Position Document 1   (EPA  1977a).

          On February 17, 1977, the Agency published  a  notice of  rebuttable
presumption against registration (RPAR) and continued registration of
pesticide products containing lindane in the Federal  Register (EPA 1977b).
Position Document 1 contains background and supporting  data for the
presumptions of risk cited in the RPAR notice.

          On April 28, 1977, Continental Chemiste Corporation petitioned
the U.S. Court of Appeals for the Seventh Circuit to  issue a  writ of
mandamus requiring EPA to withdraw the RPAR notice  against that company's.
lindane smoke insecticide products.  The company argued that  the  notice
violated the mandate of a previous decision by  the  Court  to sec aside the
                                     1-3

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Agency order cancelling Continental Chemiste  lindane  products [461  ?.2d 331
(7th Cir. Docket No. 71-1828,  1972)].  This petition  was  denied on
June 7, 19-77.

          Certain pesticide products which have  been  subject to SPA regula-
tion under the Federal Insecticide, Fungicide, and  Rodenticide Act  (FIFRA),
as amended, also fall within the statutory definition of  "new drug" in the
Federal Food, Drug, and Cosmetic Act (FFDCA)  and have been  subject  concur-
rently to regulation by the Food and Drug Administration  (FDA).   EPA and
FDA published procedures for joint review and approval of products  that
fall within the statutory definitions of both "pesticide" and "drug" in the
Federal Register of December 22, 1971 (36 FR  242334),  and September 5, 1973
(38 FR 24233). On November 9,  1979, however,  an  SPA regulation was  pub-
lished [Federal Register 44( 2 15) :63749] which exempts from  FIFRA regis-
tration requirements all pesticides which are designated  solely for use on
human persons and as such are  considered new  drugs  as defined by Section
201(p) of the FFDCA.  All lindane products designated solely for use on
human persons will therefore be subject henceforth  to regulation by the FDA.

     E.   Bases for the Rebuttable Presumption

          The lindane RPAR notice cited three risk  criteria which lindane
had met or exceeded:  (1) acute toxicity to aquatic organisms [40 CFR
162.11(a) (3) (i)(3) (3)] , (2) oncogenic effects in test animals [40 CFR
162. 1 1 (a) (3) (ii) (A)] , and (3)  chronic and/or  delayed  toxicity causing
reproductive or fetotoxic effects in test animals [40 CFR
          In addition to these criteria,  the  RPAR notice  listed four other
possible adverse effects of lindane for which insufficient  evidence existed
to initiate a rebuttable presumption.  The  Agency requested registrants and
other interested parties to submit data on  the following  effects:   (1)  muta-
genicity, (2) blood dyscrasias,  (3) acute hazards to  humans and domestic
animals, and (4) population reduction  in  nontarget avian  species.  Informa-
tion was solicited also on the additional issue of the  possible isomeriza-
tion of lindane (gamma-BHC) to the alpha  and  beta isomers of 3HC,  which
have been shown to be oncogenic  in rodents.

     F.   Legislative Background

          FIFRA and its regulations require SPA to review both the risks
and the benefits of the uses of  pesticides.   Since issuing  the RPAR notice
for lindane (SPA 1977b) , the Agency has received rebuttal comments and has
conducted in-depth risk and benefit analyses .   This position document
(PD 2/3) responds to the rebuttal comments,  summarizes  the  risks and
benefits associated with lindane, and  recommends a regulatory option for
each use .
                                     1-4

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          This PD 2/3 also satisfies the substantive  requirements of an
environmental impact statement.  It fully discusses the  scope of the
problem to be regulated, the process for selecting the alternative cours-es
of action, and the reasons for the Agency's proposed  final  decision.  It
contains five parts.  Part I is this introductory section.   Part II pre-
sents an evaluation of potential risks of lindane.  It includes  descrip-
tions of the relevant laboratory data on risks, exposure data, and the
Agency's present risk assessment.  Part III is a summary analysis of the
economic benefits of lindane.  Part IV presents the process by which,  on a
use-by-use basis, the Agency developed a range of the regulatory options
and selected specific options for in-depth evaluation.   Finally, Part V
proceeds with a risk/benefit analysis of the regulatory  options, use by
use, and summarizes the regulatory actions which the  Agency proposes to
take concerning the registration and continued registration of pesticide
products containing lindane.
                                    1-5

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H.  ANALYSIS OF REBUTTALS AND ASSESSMENT OF RISK

     As stipulated in 40 CFR 162.11(a)(4) respondents can  rebut  any presump-
tion against a pesticide by showing 1) that the Agency's initial determina-
tion of risk was in error or 2) that given current use patterns,  exposure
to the pesticide is not likely to result in any significant  chronic or
acute adverse effects.  The rebuttable presumption against registration and
continued registration of pesticide products containing  lindane  drew
responses concerning the three presumptions of oncogenicity,  reproductive
and fetotoxic effects, and acute toxicity to wildlife, aquatic organisms.
Consnents were also received concerning the possible adverse  effects of
mutagenicity, blood dyscrasias, acute hazards to humans  and  domestic
animals, and population reduction in nontarget avian  species, as well as
the additional issue of isomerization.  Submissions pertaining to the
rebuttable presumptions and to other possible adverse effects, together
with the Agency's responses and additional findings,  are reviewed in
Subsection II.A below.  Rebuttal comments pertaining  to  exposure are
addressed in Subsection II.B, "Exposure Analysis."  The  Agency's
determinations on risk are given in Subsection II.C,  "Risk Assessment."

     A.   Rebuttal Analysis

          1.   Attempts to Rebut the Presumption of Oncogenicity

               In Position Document 1, the Agency announced  a presumption
of oncogenic effects  on the basis of three laboratory studies which ob-
served oncogenic responses when lindane was tested on mice.  (See Table
II-1.)  Goto et al.  (1972) fed 5-week-old male mice 300  or 600 parts per
million (ppm) lindane for 26 weeks.  Liver tumors were seen  in 50 percent
of the  10 animals which ingested 600 ppm lindane, and a  2-fold increase in
the ratio of liver weight to body weight was observed at the same dose.
Five treated animals  (25 percent) died early in the study.  No oncogenic or
other  liver effects were observed in the animals ingesting 300 ppm lindane.
                Hanada  et  al.  (1973)  treated 6-week-old male and female mice
with  100,  300,  or  600  ppm lindane  for  32  weeks.   The animals were there-
after maintained on  a  basal diet for 6 weeks and sacrificed 38 weeks after
feeding  started.   Tumors  were  found  in 1  of 3 females and in 3 of 4 males
ingesting  600 ppm  lindane for  a combined  rate of 64 percent (7 of 11).  No
tumors were  observed in the 29 control animals,  in the 18 animals ingesting
100 ppm, or  in  the 16  animals  ingesting 300 ppm  Lindane.   Doses of 300 ppm,
however, produced  atypical proliferation  of liver cells.

                Thorpe  and Walker  (1973) fed 4-week-old mala and female mice
400 ppm  lindane for  52 to 110  weeks.  A statistically significant increase
in the incidence of  hepatic liver  tumors  was reported, as well as meta-
stases to  the lung in  the lindane-fed  animals relative to controls.  Ninety-
six percent  of  the males  had  tumors, including 11 percent metastases.
Ninety-five  percent  of the females had liver tumors with  no metastases.
                                    II-l

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Table II-1.
               Comparison of Oncogenicity  Studies  Cited in the Lindane RPAR
               Notice and the NCI Study  in Mice
               Thorpe and     Goto  et  al.
               Walker (1973)     (1972)
                                              Hanada  et al.   NCI Study
                                                 (1973)        (1977)*
Strain

Age

Sex
  1
4 weeks

Both
Number/Group   29-45

Dose (ppm) in  400
  diet
Duration
               2 years
ICR-JCL

5 weeks

Male

  20

 300
 600


26 weeks
dd

6 weeks

Both

10-14

100
300
600

37-38 weeks
               Liver tumors
               in males  and
               females,  96%
               males and 95%
               of females
               treated com-
               pared to  23-
               24% of controls
               (p <.0001).
Results        Liver tumors    Liver  tumors   Liver  tumors
                                              in  males
                                              and females
                                              (3  of  4
                                              surviving
                                              males,  1  of
                                              3 females at
                                              600 ppm;  no
                                              tumors  re-
                                              ported  in
                                              controls).
                                              Significant
                                              in  males
                                              ( p  <.013  at
                                              600 ppm.)

*The final results of the National Cancer  Institute  (NCI)  carcinogenicity
bioassay are included here for purposes  of comparison.   (Only the prelimi-
nary results were available at the time  PD1  was  issued.)  For discussion,
see Subsection II.A.I.d of text.
 Liver tumors
 in males
 (50% of
 treated
 males at
 600 ppm).
 (P=.004
 no tumors
 in unre-
 ported
 controls.)
                                                             B.C.?,
                                                              o 3 1

                                                             5 weeks

                                                             Both

                                                             50

                                                              SO
                                                             160
                                              80  weeks and
                                              30  weeks of
                                              observation

                                              Hepatocellu-
                                              lar carcinoma
                                              in  male mice
                                              at  low dose-
                                              level of 80
                                              ppm (?=0.001.)
                                              High-dose group
                                              showed less
                                              significant
                                              results (9/46
                                              vs. 5/49;
                                              p=0.10).
                                               II-2

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Liver tumors were found in 24 percent of  the  control  animals,  but no
metastases were observed.  Toxic effects  leading  to death occurred during
the first 3 months of lindane feeding for approximately 15 percent of the
animals.  Moreover, for the entire  110-week experimental period,  there was
a 90-percent total fatality record  for  lindane-fed animals as  compared to
68 percent for controls.—

               In response to our request for rebuttals and additional
information concerning oncogenicity as  a  presumed risk of lindane, the
Agency received nine responses from three registrants:  Paper  Products,
Inc.  (30000/10 :*41), Hooker Chemicals (30000/10:#42), and Reed and Camrick
Pharmaceuticals (30000/10:&6C).  The Agency has reviewed the material
submitted and has concluded that it does  not  invalidate the three studies
cited in the lindane KPAR notice and in P01 as bases  for the presumption of
oncogenicity, nor is the presumption otherwise rebutted (2?A 1978a;5PA
197Sb).-

               a.   Attempted Rebuttal  Pertaining to  Dosages Used
                    in Testing

                    Paper Products, Inc.  (30000/10:141) challenged the
Agency's presumption of oncogenicity by contesting the dosage  levels used
in the three studies on which the presumption was based.

                    Concerning the  Goto and Hanada experiments, the regis-
trant argued that the lindane dosages used were so high that only acute
toxic effects could be assessed.  Specifically, the  grounds for contention
were  1) that so many animals died from  toxic  effects  that chronic oncogenic
potential could not be assessed from the  few  remaining animals, and 2) that
the acute oral LD=Q dose for these  species was exceeded.  Concerning the
Thorpe and Walker experiment, the registrant  argued  that the study consti-
tutes weak evidence of human carcinogenicity  for  four reasons.  (1) The
dose  used (400 pom) was too high to allow meaningful  conclusions  about
carcinogenicity.—    (2) The strain  used (CFI) is  prone to hepatomas of
unknown causes.   (3) Thorpe and Walker  themselves questioned the  biological
—         Also  mentioned  in  PD1  were the following lindane studies which
           reported no  oncogenic  effects:  Nagasaki at al. (1973) and Herbst
           et  al.  (1975),  mouse  studies;  Fitzhugh et al. (1950), Truhaut
           (1954),  Ito  et  al.  (1975), and Ortega et al. (1957), rat studies.

—         The related  issue  of  whether lindane isomerizes in the
           environment  to  alpha-3HC or in rats to alpha-and beta-BHC, both
           of  which have been shown to induce oncogenic effects in rodents,
           is  addressed in Subsection II.A.4.e.

—         In  this  connection,  the registrant argued the following points:

                1)    15 percent  of the animals died in the first 3 months,
                2)    400 ppm  is  70 percent of the I*D5-, ^ the species, and
                3)    only  3 percent of the females and 17 percent of the
                     males survived the entire axiseriment.
                                      II-3

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significance of the tumors, chiefly  because  many co-factors ars known
to influence the development of  liver  tumors.   (4)  The spontaneous
incidence of extrahepatic tumors  is  very  high  (82 percent), and the lindane
treatment does not increase tumor incidence, but merely shifts the tumor
sites to the liver.

                    The Agency rejects  the above arguments.  With regard to
the Goto and Hanada experiments,  Paper  Products,  Inc.  did not state the
LD_  dose for either strain of mice  used  in  testing.   Nor did the regis-
trant cite the source for the contention  that  the LD_   for the animals
was exceeded.  The argument based on LDj-n values is thus incomplete, and
the mortality and body weight gain in  tne studies themselves must be used
to evaluate the toxicity.  The Agency  grants that the  mortality in the
Hanada study is high,—  and this,  together with the relatively short
duration of the experiment and the small  number of test animals,  makes the
study in itself only a weak indicator  of  carcinogenicity.  However, the
incidence of tumors in males was  unmistakably  high over a short period of
time (3 out of 4 lindane-treated  males  had tumors as  compared with 0 out of
14 controls; p = 0.013), and this suggests that lindane may be carcinogenic
in dd strain mice.  Because Goto  did not  state the percent survival through-
out the experiment, it is not possible  to evaluate whether non-tumor mortal-
ity appreciably influenced tumor  incidence.  Body-weight gain was normal,
but considerable liver enlargement indicated that lindane was in  some way
toxic to the liver.  The omission of control group pathology data in this
study permits only a qualitative  conclusion  that lindane apparently induced
early stages of hepatocellular carcinoma.

                    In both the  Hanada  and Goto experiments, the  liver
lesions consisted of tumors of the liver.  In  both experiments, the
findings are consistent with either  carcinomas or the  early stages of
hepatocellular carcinoma.

                    With regard  to the  Thorpe  and Walker experiment, the
Agency acknowledges that mortality among  the treated  group (especially
females) was higher than among the controls.  Nonetheless, the cumulative
tumor incidence among treated animals  at  three different stages (17, 21,
and 25 months) of the experiment  was significantly higher than among con-
trols.  Early mortality from the  toxic  effects of lindane was thus not
great enough to mask the carcinogenic  effects.  Regardless of other possi-
ble factors, the lindane-treated  animals  definitely developed a higher inci-
dence of liver tumors than did controls.  This is sufficient cause for con-
cern that lindane could have a carcinogenic  effect in  humans.  Concerning
the registrant's contention that  lindane  treatment merely transferred
tumors to the liver, the Agency  points  our  1)  that it  is extremely diffi-
cult to interpret changes in the  incidence of  tumors  at several sites ccm-
4/
—         Out of  the  initial  group  of  approximately 10 animals, only 3
          females  and 4 malas survived to 36 weeks at 600 ppm.
                                  II-4

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bined, as was  done  with  extrahepatic tumors;  and 2)  that the decrease in
the  incidence  of  extrahepatic  tumors was  not  statistically significant.
For  these reasons the  reduction in extrahepatic tumors does not decrease
the  significance  of the  tumors induced by lindane.

                b.    Attempted  Rebuttal Pertaining to Liver Toxicity as a
                     Test Interference

                     Paper Products,  Inc.  (30000/10:141) argued also that
not  only lindane  but any compound  given in doses large enough to produce
extensive liver toxicity will  produce liver tumors.   The further implica-
tion was that/  at doses  low  enough to be  non-toxic to the liver, no carcino-
genic  response would occur,  and the  compound  would be safe.

                     The  Agency rejects this argument.  The registrant's
contention  is  based on a hypothesis  which has not been established.  It is
unfortunate  that  liver toxicity is not ordinarily examined in carcino-
genesis tests, and  information on  this point  is seldom available.  Until
such a correlation  is  shown, the Agency's position is that the coincidence
of  liver toxicity with a carcinogenic response is not sufficient reason for
disregarding the  carcinogenic  potency of  a compound.

                c.   Additional Studies Submitted in Attempted Rebuttal

                     In attempt to  counter the three studies on which the
.presumption  of oncogenicity  was based, Hooker Chemicals (30000/10:342)
cited  an 80-week  study by Weisse and Herbst (1976).   Weisse and Herbst
studied the  carcinogenic potential of lindane at 12.5, 25, and 50 pom dose
levels in the  food  of  NMRI male and  female mice, 250 of each sex total.
The  reported results showed  no evidence of increased tumorigenicity.

                     The  Agency rejects this rebuttal attempt.  Weisse and
Herbst used  a  different  strain of  mice and lower dose levels than did the
three  oncogenicity  studies cited in  the RPAR notice.  Uncertainties about
the  maximum  .tolerated  dose in  this strain make it difficult to assess
whether the  dose  was high enough to  cause a statistically observable
response.  The three independent studies  cited as bases for the original
presumption  of oncogenicity  showed a definite excess tumor induction in
treated groups.  The presence  of a fourth study with negative results at
uncertain dose level does not  diminish the Agency's concern that lindane is
potentially  oncogenic  in humans.

                     Likewise in attempt to rebut the Agency"s presumption
of  oncogenicity,  both  Hooker Chemicals (30000/10:?42) and Reed and Carnrick
Pharmaceuticals (30000/10:#6C) submitted various studies which on the whole
indicated no connection  between lindane and mutagenic effects.

                     The  Agency rejects these  rebuttal attempts for two
reasons:   1) mechanisms  other  than mutation may cause cancer; 2) although
for some classes  of chemicals  there is a high correlation between carcino-
genicity in  mammalian  test systems and mutagenicity in certain microbial
                                   II-5

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systems/ this correlation is not absolute,  and  false  positive and false
negative indications do occur (EPA 1978a,  1978b).   Moreover,  three of the
tautagenic tests submitted by Hooker Chemicals in  fact showed  positive
results.  These positive mutagenic results  lend further  support to the
Agency's original presumption of lindane's  oncogenicity  (SPA  1978b).

               d.   Comments Submitted on  the National Cancer Institute
                    (NCI) Carcinoqenicity  Bioassay

                    Although the NCI preliminary  bioassay  study on the
oncogenic effects of lindane was not a basis for  the  lindane  KPAR, it was
mentioned in the RPAR notice, and comments  on its significance were soli-
cited.  In response, the registrants submitted  the  NCI final  bioassay
report, which concluded that the study did not  in itself demonstrate  that
lindane is carcinogenic.  (Refer to Table  II-1, which compares the results
of the NCI study with the results of the three  oncogenicity studies cited
in the RPAR Notice.)

                    The Agency rejects this rebuttal  effort.   While the
authors of the NCI bioassay concluded that  because  of the  insufficiency of
their data, the bioassay does not constitute sufficient  evidence of the
carcinogenicity of lindane, it does add to  the  body of evidence of similar
results found in the other three studies in that:

                    (1)  The liver was the  target organ.   In  the NCI  study
lindane at 80 ppra triggered a highly significant  response  (hepatocellular
carcinoma) in male mice vs. pooled controls (19/49  vs. 5/49;  p = 0.001).
While the high-dose group (160 ppra) did not show  a  significant increase (9/
46 vs. 5/49; p = 0.10), there was nevertheless  an increase.

                    (2)  Males were more susceptible  than  females.

                    In addition to the above similarities,  the NCI study
provides evidence involving the same target organ in  a different strain.
The Agency therefore judges that, considered together with  the Thorpe and
Walker (1973), Goto et al. (1972), and Hanada et  al.  (1973) studies,  the
NCI study provides additional evidence of  the carcinogenicity of lindane.!/

          2.   Attempts to Rebut the Presumption  of Reproductive and
               Fetotoxic Effects

               In Position Document 1 the  Agency  announced a  presumption of
reproductive and fetotoxic effects on the  basis of  three lindane feeding
studies:  Naishtein and Leibovich (1971),  Petrescu  et al.  (1974), and Earl
—     The NCI study was  terminated  after  only 90 weeks  because of the
          poor condition of  the animals.   Since  liver tumors  are  often lat;
          appearing,  the latent period may not have  beer.  Long enough to
          result  in the  detection of  ail  potential liver  tumors from the
          lindane axrosura.
                                 Il-fi

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et al. (1973), all of which reported adverse reproductive/fetotoxic  re-
sponses.  The results of each of these RPAR studies are summarized in
Table II-2.  In response to our request for rebuttal comments  and
additional information concerning the reproductive and fetotoxic effects
of lindane, the Agency received 15 responses from 3 registrants:  Hooker
Chemicals (30000/10:1*42), Franklin Laboratories  (30000/10:*37), and  Paper
Products, Inc. (30000/10:*41).

               The Agency has reviewed all rebuttal material submitted by
the registrants (EPA 1978c) and concludes regarding the original RPAR
studies 1) that the Russian studies Naishtein and Leibovich  (1971) and
Petrescu et al. (1974) have a number of flaws which render them inadequate
to completely assess the reproductive effects of lindane  and 2) that Sari
et al. (1973), which showed that lindane feeding significantly increased
the proportion of stillbirths to beagle dogs, stands unrebutted as valid
evidence of the fetotoxic effects of the pesticide.

               While Earl et al. remains unrebutted as an original RPAR
study, several studies which have come to our attention during the rebuttal
period reinforce the Agency's concern about the reproductive and fetotoxic
effects of lindane.  Seven studies submitted in attempted rebuttal by
Hooker Chemicals in fact indicate that lindane affects the reproductive
performance of.the animals tested as well as the condition and/or survival
of the fetus.—   Two additional studies, Khera et al. (1979.) and
Trivonva et al. (1970), which the Agency has recently reviewed, provide
further indications of lindane-related fetal and reproductive  effects.

               The Agency's risk assessment of the reproductive and  feto-
toxic effects of lindane has necessarily focused on fetotoxic  effects. (See
Subsection II.C, "Risk Assessment.")  The quantitative analysis is based on
data provided by Khera et al. (1979), Palmer and Lovell  (1971), Palmer and
Neuff (1971), and Bauer and Frohberg (1972), the latter  three  studies
having been submitted during the rebuttal period by Hooker Chemicals (Table
II-3).  The Agency was unable to perform a quantitative  risk assessment  of
the general reproductive effects of lindane based on available data.
6/
—         These studies  (addressed  in  Subsection  II.A.2.e  below and
          summarized in  Table II-3)  stand as evidence  that lindane  causes
          no teratogenic effects  in rats, mice, or  rabbits.   However,  the
          Agency's presumption was  based not on teratogenicity,  but on
          general reproductive and  fetotoxic effects.   An  eighth rebuttal
          study (Table II-3) submitted by Hooker, which indicated only that
          lindane decreased the growth rate of female  pigs prior to mating,
          did not address the presumption.
                                     II-7

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  Tabla II-2.  Summary of Studies Cited as  3ases  for  the  Presumption of
           Reoroductive and Fetotoxic Effects
Species
   Protocol
       Results
                                                    Reference
Mongrel
rats
0.05 and 0.5 nig/kg
in diet for 4 months
prior to mating &
pregnancy
I Increase in duration
I of estrous cycle and
I increased duration of
Iestrous at high dose;
I no effect of low dose.
                                                 Naishtein  &
                                                 Leibovich
                                                 (1971)
Rats
5,  10, or 15 mg/kg
in diet in P, F ,
F , & F  group
                         I Lengthened avg. dura-
                         ttion of pregnancy;
                         [decreased fertility
                         I index in 15 aig/kg
                         I group? retarded sexual
                         I maturation & depressed
                         I sexual function; pro-
                         lgressive increase  in
                         I proportion of  still-
                         |births in successive
                         I generations.
                         Petrescu et
                         al. (1974)
Beagle
dogs
7.5 or 15 mg/kg per
day in diet from day
1 or 5 of gestation
I Increased frequency of
I stillbirths in treated
I animals from 2% in
I controls to levels of
|c.18%,  23%, and 30%
I in dogs ingesting lin-
Idane at 7.5 mg/kg/day
I(beginning on either
I day 1 or day 5) or
115 mg/kg/day (begin-
|ning on day 5)  during
|pregnancy.  (No signi-
|ficant teratogenic
I effects.)
                                                 Earl  et  al.
                                                 (1973)
                                   H-8

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               The Agency's analysis of the rebuttals  submitted regarding
the presumption of reproductive and fetotoxic effects  is presented in the
succeeding Subsections II.A.4.a through e.  Additional Agency  findings are
addressed in Subsection II.A.4.f.

          a.   Attempted Rebuttals Pertaining to Naishtein
               and Leibovich  (1971)

               Two registrants objected to this study.   (Refer to  Table
II-2.)  Hooker Chemicals (30000/10:*42) argued that data essential for peer
evaluation were not provided.  Franklin Laboratories  (30000/10:#37)  argued
that the study was based on an unknown number of test  animals.

               The Agency acknowledges that the data in  the Nashstein and
Leibovich study is not presented in sufficient detail  and doesn't  meet
Agency standards in sustaining a presumption.  However,  even with  these
deficiencies, the study does provide supportive information on fetotoxicity
which strengthens the conclusions reported in the Earl et al.  study and
other studies (see Section II.2.e.).

          b.   Attempted Rebuttal Pertaining to Petrescu et al.  (1974)

               Hooker Chemicals (30000/10:342) argued  that Petrescu et al.
(Table II-2) did not meet currently acceptable scientific standards:   1)
there was no discussion of toxic effects in dams; 2) there were too few
test animals per group; 3) the study was unusual in design (pregnancies
were repeated over the animals' lifetime for the F  generation); 4)  there
was no information on anticipated  normal pathology in  experimental or con-
trol groups; and 5) the fertility  index appeared to be unusually low for
all groups, including control groups.

               This rebuttal  is accepted (EPA  197Sc).  The Agency  acknow-
ledges that Petrescu et al. shows deficiencies in design and  fails to pro-
vide sufficient data so that  the reported findings can be adequately
judged.

               The Petresca study  did show effects on  fetotoxicity at doses
below those established for causing acute and subacute effects ( 5 mg/kg).
The presence of a second study (Palmer et al., 1972)  (see Table II-3)
reporting no effects does not detract from Petrescu's  reported results.
However, the Palmer study does reduce the strength of  the Petrsscu study
and accordingly the Agency will not attempt to use Petrsscu as the sole
support of the fetotoxicity presumption, although the  Agency will  use
Petrescu1s results as supportive information in evaluating the risk of
fetotoxicity.

          c.   Attempted Rebuttals Pertaining to 5arl  et al.  (1973)

               Two registrants objected to this study.  (Refer to  Table
II-2.)  Hooker Chemicals  (30000/10:242) argued that the  study  was  invalid
in that 1) it lacked sufficient information for evaluation and 2)  it used
                                  II-9

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non-concurrent controls.  In addition, Hooker cited  a  32-week study in non-
pregnant beagles (Noel, 1970) which indicated that lindane (200  ppm dietary
intake) caused toxic effects at doses as  low as 5 erg/kg-per day.   Franklin
Laboratories (30000/ 10:$37) argued that  the apparent  increase in the inci-
dence of stillborn animals from lindane feeding was  inconclusive because a
7.5 mg/kg dose produced 30.5 percent stillborn, while  double that dose pro-
duced only 17.9 percent stillborn  (a reduction of nearly half).

               The Agency rejects  these rebuttal attempts (Memo  1978a;
1978b).  The Earl et al. study was published in 1973,  and data from the con-
current controls were generated from January 1970 through October 1972.
Sari et al. provided data from several control groups,  at least  one of
which is clearly "concurrent" with the test groups.  For this control
group, the percentage of stillborn pups was 5.7 percent,  as compared to
30.5 percent stillborn in the 7.5 mg/kg group.  The  beagle study (Noel,
1970) cited by Hooker is not inconsistent with the observation of fetotoxic
effects in beagles at higher doses by Earl et al.  (1973).   The apparent
lack of a dose-response relationship does not invalidate the observed
increases of stillborn animals in  treated groups as  compared to  controls.

          d.   Attempted Rebuttals Pertaining to Exposure;   Fetotoxicity

               For chronic effects risk criteria such  as fetotoxicity,
Agency regulations require the Administrator to determine whether the
effect occurs at a dose level "substantially higher  than that to which
humans can reasonably be anticipated to be exposed,  taking into  account
ample margins of safety" [40 CFR  162.11(a)(3)(ii)(B)1.   As Position Docu-
ment  1 stated, "In the absence of  an established level at which  there was
no demonstrated effect and with a  subsequent lack of basis for choice of an
'ample margin of safety,' it may be presumed that current exposure is suffi-
cient to produce reproductive and  fetotoxic effects  in humans" (EPA 1977a).

               Only one respondent specifically addressed the issue of
ample margins of safety.  Paper Products, Inc.  (30000/10:341) construed the
applicable passage of 40 CFR (cited above) to mean that the Administrator
must make a specific determination of an  ample margin  of safety  and argued
that, "unable to meet the evidentiary standards of its own regulations, the
EPA has simply dispensed with them."  The registrant noted in this context
that  its product (shelf paper) contains 15 ng of lindane per square foot
and argued that, using the smallest doses cited in Position Document 1 (0.5
mg/kg), a pregnant woman would have to ingest 2 square feet of the product
per day for four months to obtain  a dosage comparable  to that used in
Naishtein and Leibovich.

               The Agency rejects  the registrant's interpretation of Agency
regulations.  The "evidentiary standards" of Agency  regulations  are ad-
dressed in the Subsection II.C.2 of this  document, which establishes a no
observable effect level and discusses margins of safety for fetotoxic
effects from lindane exposure.  The Agency points  out  also that  the prin-
cipal  route of exposure to this product is inhalation  of lindane vapor
                                   H-10

-------
released from shelf paper.   [See Subsection  II.B.2.m.(1}.]   In its risk
assessment of lindane shelf-paper products,  the  Agency does  not consider
ingestion to be an anticipated route of  exposure.

          e.   Additional Studies Submitted  in Attempted Rebuttal

               In attempt to rebut the presumption  of  reproductive and
fetotoxic effects, Hooker Chemicals  (30000/10:S42)  submitted the following
seven studies which indicated no connection  between lindane  and teratogenic
effects in mice, rats, or rabbits:   two  mouse studies  by Bauer and Frohberg
[1972 (confidential; unpublished)],  one  in which lindane was administered
via stomach tube and one in which lindane was injected subcutaneously;  a
'rat study by Palmer and Lovell  [1971 (confidential;  unpublished}]  in which
lindane was administered by intubation;  a rabbit study by Palmer and Neuff
[1971 (confidential; unpublished)] in which  lindane was administered via
intragastric intubation; a 3-generation  rat  study by Palmer  et al. [1972
(confidential; unpublished)] in which lindane was administered in the daily
diet; a rat study by Reno [1976 (confidential; unpublished)]  in which
lindane was injected subcutaneously; and a rabbit study by Reno [1976
(confidential; unpublished)] in which lindane was injected subcutaneously.
Hooker also submitted an eighth study, a French  study  by Duee et al.
(1975), in which'female pigs were administered lindane in the daily diet.
Lindane apparently had no effect on  the  weight gains of the  sows during the
first month of gestation or on their rate of ovulation,  and  the number of
embryos and their weight were likewise reported  unaffected.   Table II-3
summarizes these eight studies.                                 . •

               The Agency rejects these  rebuttal efforts (SPA 1973c; memo
197Sa, 1978b).  Regarding the rat, mouse, and rabbit studies, the Agency
grants that no teratogenic effects (birth defects)  were observed.   However,
it must be emphasized that teratogenic effects are  not at issue.  The
Agency's original presumption was based  not  on teratogenicity but on general
reproductive or fetotoxic effects.   Fetotoxic effects  were in fact observed
in the submitted studies at  or  near  (both below  and above) doses that
caused maternal toxic effects.

               The Agency has reviewed Duee  et al.  (1975)  in translation
and  finds that although no overt  fetotoxic  effects  were observed,  a lack of
data in the paper undermines the usefulness  of the  study.   However, while
the  Duee study cannot be used for establishing and  providing sole support
of a presumption, the study  does provide information on lindane's adverse
effects and adds to  that body of knowledge.

          f.   Additional Agency Findings Concerning the Presumption of
               Reproductive  and Fetotoxic Effects

               In addition to the eight  studies  submitted during the rebut-
tal  period by Hooker Chemicals, Agency research  has discovered two further
studies, Xhera at al.  (1979) and Trivonva et al. (1970 [reviewed in
abstract]) of the renroductive  and fetotoxic effects of lindane on rats.
                                    11-11

-------
Table II-3.
Summary of Studies Submitted in Attempt  to  Rebut the Presumption
of Reproductive and Fetotoxic Effects

Species

NMRI
mice















NMRI
mice
































Exposure 1 Duration of
Route | Exposure
1
Subcuta- | Days 6-15 &
neous | 11-13 of
| gestation
I
I
I
I
I
I
I
I
I
I
I
I
I
I .
I
Stomach | Days 6-15 &
tube | 11-13 of
I gestation
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
!
I
I
I
I
I
Dose | Results
I
6 mg/kg | Percent abortions ,
daily (early & late
[resorptions , mean
| fetal length, S
I sex ratio in test
I groups comparable
| to controls.
I Statistically sig-
Inificant increase
I in $ of congenital
Irunts in day 6-15
(group; 6 of 7
Irunts were from
I same liter.
|No teratogenic or
I maternal toxic
(effects observed.
1
12, 30 , | In day 6-15 group
60 (at 60. rag/kg, # of
mg/kg (abortions signifi-
daily (cantly increased,
(mean 1 of fetuses
| lower than in con-
(trol groups; mean
(fetal- weight sig-
Inificantly reduced
(as compared to
(controls receiving
I carrier/vehicle;
(this increase was
| significant com-
(pared to entire
(control group.
(The increase
| in abortions at
1 1 2 mg/kg/ day ( days
| 11-13) may not be
| lindane-related
| since the effect
(was not seen in
| the group fed 12
|mg/kg on days 6-15
(nor in the groups
| fed 30 mg/kg and
| 60 ag/kg on days
1 11-13. Maternal
| toxic ef f ecrts
(observed at 50
jag/kg; none at 30
(or 12 ag/kg.
. I

Reference

Bauer and
Prohberg [1972
(Confidential;
unpublished) ]













Bauer and
Frohberg [1972
( Confidential ;
unpublished) ]






























                                         11-12'

-------
Table II-3.
 Summary of Studies Submitted in Attempt to Rebut the  Presumption
 of Recroductive and Fetotoxic Effects  (Cont.)
I  Species
I	
(Female
(Specific
I Pathogen
(Free Rats
Exposure
 Route
 Duration of
  Exposure
 Dose
Results
Reference
Intuba-
tion
Days 6-15 &
gestation
                      I
0, 5, 10|Food consumption
20 mg/kgland maternal
 daily  (weight gain were   (
        (decreased at the 21
        (higher doses.
        I Statistically sig-
        (nificant increase
        |in skeletal varia-
        jtion (extra ribs)
        (at high dose.
        (Possible increase
        (in extra ribs at
        (middle dose.  NOEL
        |for fetal and
        (maternal affects 5
        (mg/kg/day.
	I	
                Palmer and
                Lovell   [1971
                (Confidential;
                unpublished)]
  New Z.
  white
  rabbits
Intra-   |  Days 6-18 of
gastric  |  gestation
intuba-  |
tion     |
         I
              0, 5,  10|All treated
              20 mg/kg|animals showed
               daily   (increased respira-
                       (tion and drowsi-
                       Iness and decreased
                       [weight gain;  * of
                       (animals which con-
                       (ceived slightly
                       (lower at 10  & 20
                       |mg/kg.  Statisti-
                       (cally significant
                       (decrease in  13-
                       |ribbed pups  at 5
                       |mg/kg and an in-
                       | crease at 20 mg/
                       |kg.  Since in rab-
                       |bits the normal  If
                       (of ribs is  12
                       (pairs, the effects
                       (at 5 me/kg are not
                       (adverse.
                              Palmer  and
                              Neuff  [1971
                              (Confidential;
                              unpublished)]
                                        11-13

-------
Table II-3.  Sunanary of  Studies Submitted in Attempt to Rebut  the Presumption
             of•Beoroductive  and Petotoxic Effects (Cont.}

Species
| Charles
River
Rats




































Rats









Exposure | Duration of |
Route | Exposure 1 Dose Results
!
Diet Continuous |0, 25, No adverse effects
|for 3 genera- | 50 , or in parental gener-
Itions |100 ppm ation. No effects
| | daily on litter mortali-
| | jty, size, and
I | [weight or mean pup
| | weight from birth
I | |to 21 days post .
| I Ipartum. Mean ab-
| | | so lute liver
| | | weights in high
| | | dose males and fa-
| | | males of F-3b gen-
| | jeration signifi-
| | | cantly increased
| | |(p<0.01) compared
| | to controls. Mean
| | [relative organ
| | [weights signifi-
| | jcantly increased
| | | (p< 0.001) in high-
| | jdose males . Female
| | | liver/body weight
| | [significantly in-
| | [creased in females
| at all doses
| | (p<0.00 1 at high
I | [dose) . Enlarged
| [hepatocytes in-
| | [creased in 50 and
| | | 100 pcm groups.
| | [Gestation index in
| | |F-Ob litter was
| [98.9% in controls
| and 92.7^ in high-
| | [dose group ( due to
| | | 13 of 15 stillborn
| [litter).
i
Subcuta- Days 6-15 of | 0 , 5, 15 [All doses caused
aeous gestation [30 ag/kglan increase in
injection | daily fetuses having an
| extra rib when
| compared to con-
| trols. ^OEL for
| jaiatemal effects
| is 5 ag/kg; natar-
i | ( cent . )
I

Reference
Palmer, Cozens,
Lovell et al .
[1972 (Confi-
dential ; uncub-
lished)]














'



















Reno [1976
( Confidential ;
unpublished) ]



I

i

                                        11-14

-------
Table II-3.  Summary of Studies Submitted in Attempt  to  Rebut  the  Presumption
             of Reproductive and Fetotoxic Effects  (Cont.)
I Exposure | Duration of
Species | Route | Exposure
1 1
Rats | |
(Cont.) | |
1 1
1 1
1 1
1 1
1 1
Rabbits | Subcuta- | Days 6-18 of
| neous | gestation
| injection |
I I
I I
I I
I I
I I
I I
I I
I I
I I
I • I
I I
I I
I I
I I
I I
I I
I I
I Female I Diet 1 30 days prior
I pigs | | to mating and
| | 30 days of
I (gestation
I I
I I
I I
I I
I I
I I
I I
I I
I
Dose | Results
I
|nal toxicity ob-
| served in two high
| dose groups . No
| teratogenic
(effects observed
| in fetuses.
I
0 , 5 , 1 5 | No embryotic or
mg/kg; | teratogenic
high- (effects in 5 & 15
dose | mg/kg fetuses.
group: (Maternal toxicity
45 (observed in 15 and
mgAg/ (45-30 mg/kg
days, 6- | groups. High-dose
9, S 30 [fetuses not ex-
mg/kg, (amined for terato-
days | genie effects due
10-18 (to high incidence
| of maternal toxi-
(city. Statist-
ically significant
(incidence of re-
j sorptions observed
| at 45-30 mg/kg.
I
I
0.50 and | Both doses appar-
500 ppm (ently decreased
daily | growth rate prior
| to mating . No
| effects on weight
(gain during first
| month of gestation
|nor on 
-------
               Khera et al. (1979) administered  orally  a 50  percent lindane
formulation, Senesan, to pregnant rats from day  5  through 15 of gestation.2/
The doses used were 6.25,  12.5, or 25 mg/kg/day  of the  formulation, corres-
ponding to approximately 3.15, 6.25, or  12.5 mg/kg/day  technical lindane.
Although maternal body weight data were  not given,  the  authors  reported
that the average maternal  body weight for  the  high-dose group decreased on
day 15 and at necropsy, though this decrease was not  considered statistic-
ally significant.  There was no compound-related effect on incidence of
live fetuses, dead plus resorbed fetuses,  or mean  fetal weight, and the
incidences of anomalous litters and individual anomalies were similar to
controls.  There was, however, an apparent increase in  the number of
fetuses having wavy and extra ribs and delayed ossification  of  calvarium
in the mid-dose group.  This increase was  not  tied to a significant
increase in the number of  litters with anomalous fetuses per the number of
litters examined, but rather was the result of large  numbers of affected
fetuses within fetus litters.  Effects analogous to those observed at the
mid-dose level were not observed at the  high-dose  level (12.5 mg/kg/day)
though slight maternal toxic effects were  evident  at  this dose.—

               Trivonva et al. (1970) fed  lindane  to  female  rats for 90
days at 5 mg/kg/day and for 138 days at  10 mg/kg/day.   No reproductive
effects were observed at the lower dose, whereas the  higher  dose caused a
reduction in litter size and fecundity.

    3.    Comments Submitted on the Presumption  of Acute Toxieity to
          Wildlife;  Aquatic Organisms

          In Position Document 1, the Agency cited studies showing that
application of greater than 0.000116 pounds/acre of Lindane  to  a 6-inch
layer of water would exceed one half the 96-hour t,C_, for pink  shrimp, a
marine/estaurine species having the lowest I*C_.  among representative spe-
cies.  Also cited were studies showing that application of greater than
0.00273 pounds/acre of lindane in a 6-inch layer of water would exceed one
half the 96-hour LC   for  brown trout, a fresh-water  species having the
lowest LC--: among representative species.
7/ Xhera et al. are employed by  the Bureau  of  Chemical  Safety,  Canadian
   Government.  Benesan was obtained  through Chipman  Chemicals  Ltd.,
   Stoney Creek, Ontario.

8/ Because of  the uncertain pattern of  the  results  reported by  Xhera  et
   al.  (no dose-response was established, and  the effects  observed at 6.25
   mg/kg/day were relatively slight), the Agency has  for risk assessment
   purposes considered the no observable effect  level (ilCEL)  of this  par-
   ticular study to be 12.5 mg/kg/day as the authors  concluded.  (See
   Section II.C.2.)
                                   11-16

-------
          The Agency received no rebuttals  to  this  presumption of risk.
However, the United States Department of  Agriculture (30000/10:*13)
commented that in the USDA Forest  Service's "operational  use of lindane,
precautionary measures are taken to ensure  that  the spray does not
directly, or indirectly, get into  streams."  Likewise,  Hooker Chemicals
(30000/10:142) suhmitted that "lindane  should  not be applied directly to
water."

          The Agency points out that the  original presumption of acute toxi-
city to aquatic organisms was issued even though no known lindane products
remain registered for aquatic uses  1) to  insure  that all  lindane products
with label directions for aquatic  use would be acted upon,  and 2)  to
address registered non-aquatic uses which — via means  such as .drift or
runoff — might result in lindane-contaminated aquatic  environments.  Be-
cause no lindane products are currently registered  for  direct aquatic appli-
cation, the presumption is hereby  withdrawn.   The Agency  remains concerned,
however, about the possibilities of drift or runoff should any non-aquatic
lindane product be misused.

    4.    Comments Submitted and Agency Findings on Possible Adverse Sffects

          In addition to initiating presumptions on oncogenicity, reproduc-
tive and fetotoxic effects, and acute toxicity to aquatic organisms, the
Agency requested additional evidence in situations  where  it had reason to
believe risk concerns were present.  The  Agency  sought  information both in
situations where additional information could  assist the  Agency in
determining where its risk criteria were  met and  in situations, where the
potential of. unreasonable adverse  effects,  outside  the  triggers, were
presented.—   The Agency has chosen to  treat significant  risk informa-
tion not anticipated by current risk triggers  as giving rise to risk
concerns that are appropriately handled within the  framework of the  RPAR
process and is therefore including this type of  risk information in  this
Position Document.

          The effects where the Agency  sought  additional  information
include  (1) mutagenicity,  (2) blood dyscrasias (3)  acute  toxicity hazard to
humans and domestic animals, and  (4) population  reductions in non-target
avian species.  The Agency also requested registrants and other interested
persons to submit information on  the possible  isomerization of gamma - 3KC
(lindane to alpha - or beta BHC,  which  have been  shown  to be oncogenic in
rodents.  The succeeding subsections treat  the potential  adverse effects
listed above, and give the Agency's assessment of the information received
and  its additional findings conerning these effects.
9/
—   In  situations  where  a pesticide's use presents unreasonable risks
    not  covered by the RPAR criteria,  Section 162.11(a)(S)  provides that
    the  Agency may commence cancellation proceedings.  However, where the
    Agency  is issuing a  proposed RPAR decision document,  it is in the
    public  interest for  the Agency co include all risk concerns bearing on
    registrability in this  document,  including additional risk information
    outside the  SPAR triaaers.
                                  11-17

-------
          a.   Studies Submitted on Possible Adverse  Effects;   Mutagenicity

               In Position Document 1 the Agency cited  several  investiga-
tions of lindane's mutagenic capacity and concluded that  existing data  did
not establish that lindane is a mutagen, and that risk  criteria warranting
a rebuttable presumption had not been met.  Additional  information on this
area of concern was solicited, however, and during the  rebuttal period,  two
registrants, Hooker Chemical Co. (30000/10:242) and Reed  and Carnrick
Pharmaceuticals (30000/10 :=r6C) , submitted several studies (Table II-4)  on
the mutagenic potential of lindane, all of which have been  reviewed by  the
Agency (EPA 1978C).  Although lindane triggered positive  mutagenic re-
sponses in two metabolic activation tests and one host-mediated assay with
S. typhimurium, negative mutagenic results were observed  in one metabolic
activation test with S. typhimurium, two dominant lethal  studies in rats,
and one cytogenetic analysis of Chinese hamster bone  narrow.

               The Agency has also reviewed a report  by Ishidate and
Odashina (no date) of a cytogenetic assay in Chinese  hamster £ibroblasts,
in which the authors observed gaps and breaks occurring at  the  high dose.
In evaluating this study, the Agency found that the occurrence  of breaks
was not statistically significant.  The reported observations of gaps and
breaks at a dose which appeared to produce cytotoxicity and in  the absence
of a dose-effect relationship, do not support a presumption of  mammalian
mutagenic potential.
                                                                          «
               The Agency has reviewed and evaluated  all  data which have
become available since PD 1 was issued (EPA 1978a; EPA  1978b; SPA 1978c).
In view of the test results outlined above and  in Table II-4, the Agency
reaffirms its original position that on the basis of  available  evidence no
presumption of mutagenicity is justified at this time.     However, because
indications of mutagenesis constitute indirect evidence of  carcinogenicity,
the positive responses observed in several studies have bearing on the
Agency's presumption of oncogenicity (EPA, 1979).  The  presumption of
oncogenicity is thereby qualitatively reinforced.

          b.   Comments Submitted and Additional Agency Findings _on Possible
               Adverse Effects;  alood Dvscrasias

               In Position Document 1 the Agency cited  several  case studies
which indicated that aplastic anemia, hypoplastic bone  marrow,  and other
blood dyscrasias in humans were associated with exposure  both to lindane
alone and to lindane in combination with other chemicals.  Additional infor-
mation was  solicited.  The Agency pointed out in ?D1  that the medical case
histories cited did not satisfy epidemiologic criteria  for  establishing a
cause-effect relationship between lindane exposure and  blood disorders.
However, the Agency was, and is, concerned that differences in  sensitivi-
ties may create a subgroup of the population which might  be more than
ordinarily  susceptible to possible lindane-related blood  dyscrasias.  In
this connection the Agency is especially concerned about  cases  of exposure
to children.
                                  H-13

-------
Table II-4.  Summary of Studies Submitted on Lindane  as  a Possible Mutagen
(Rebuttal *
I Reference
1
|Van Dijck
|& Van de
I Voorde
1(1976);
|*42 (Vol.
I IV, |
I Sec. 36)
I
(Reno
I (1976)
I #6 (pp.
| 104-118)
I
I
I
I
I
I
I
I Rohrborn
1(1975);
|*42, (Vol.
|V, Sec.
I 39)
I
I
I
I
I
I Rohrborn
1(1977);
|*42, (Vol.
|V, Sec.
I 40)
I
I
I
I
I

Study Type
Ames test (metabo-
lic activation with
mouse liver micro-
somes); Dose-
response test
with activation

Dominant lethal









Ames test (metabo-
lic activation with
mouse liver micro-
semes)





Ames test (metabo-
lic activation with
mouse liver micro-
somes)






Species & Strain
S. typhirmurium ,
TA 98, 100, 1535,
1537, 1538, 1950,
1978



Sprague-Dawley
rats








S. typhimurium,
TA 1535, & 1538







S. typhimurium,
TA 100, 98, 1535,
5 1538







Doses
1 & 1,000
ug/plate ; 1 ,
10, 100, &
1000 ug/
plate


0, 1, 3, & .
10 mg/kg
daily,
subcutane-
ous injec-
tion for 10
weeks



0.3125,
0.625, 1.25,
2.5, S 5 ug/
plate





93, 139, S
208 ug/plate








Results
No DNA killing
or reversion to
Iprototrophy ; No
Imutagenic
[potential
I

I Significant
increase in
I dead implants
at week 1
(appeared to be
I function of
statistics a
low control
lvalues ; no dose
I response
Probable base-
Ipair substitu-
tion (TS 153 S);
I highly signifi-
cant increased
I frequency of
[frame shift
[mutation ( 195X)
in TA 1538
I
Slight bac-
| teriostatic
[effect; 2.59X
I increase muta-
[tion in TA
1535; 2.72X in-
crease in TA
1539 at highest
[dose
 •All rebuttal  references  cited  carry the  prefix 30000/10.
                                        11-19

-------
Table II-4.  Summary of Studies  Submitted on Lindane  as  a  Possible Mutagen (Cont.)
I Rebuttal
I Reference*
1
| Rohrborn
1(1976);
If 42, (Vol.
|V, Sec.
141)
I
I Rohrborn
1(1976);
|*42, (Vol.
|V, Sec.
|42)
I
I Rohrborn
1(1977);
1 342, (Vol.
|V, Sec.
|43)
I
ICerey
I et al . ,
|1975
I

Study Type
Host activation
(male NMRI mice)



Cytogenetic bone
marrow analysis



Dominant lethal**




Dominant lethal




Species & Strain
S. tychimurium,
TA 1535



Male & female
Chinese hamsters



Male rats




Male rats




Doses
0.5, 5, & 50
mg/kg



0.125, 1.25
& 12.5 mg/
kg for 5 •
days

1.5, 7.0 S
15 mg/kg per
day for 8
weeks

1.5, 7.0 SL
15 mg/kg per
day for 8
weeks
I
I Results
I
I8.73X increased
I mutation at
I highest dose
I
I
I
I No significant
I responses;
I doses were 10 ,
|100, S 1,OOOX
| AD I for humans
I
| None
I
I
I
I
I
I Reported as
I positive**
I
I
 *All rebuttal references cited carry the prefix  30000/10.

**The Cerey et al. study was reported as positive, but no  supporting data was
  included in the publication.  The Agency also could not  obtain  the necessary
  information from the authors.  Therefore, while  the authors  claim this  study
  to be positive, without the substantiating data, the Agency  will not attach
  any significant strength to this study.
                                    11-20

-------
               Concerning blood  dyscrasias  as  a possible adverse effect
of lindane, the Agency received  16  responses  frcm four registrants:  Hooker
Chemicals, Franklin Laboratories, Paper  Products, Inc.,  and Seed and
Carnrick Pharmaceuticals.   Six of the  submissions (30000/10: ir4A; 34B; =MC
$18A; #41; $42)   were indeterminate  as  to  whether there exists a cause-
effect relationship between  lindane exposure  and blood dyscrasias in
humans.  Of those six submissions,  three argued that exposure from specific
lindane products was so  low  that no risk is involved.   Another four submis-
sions from Hooker Chemicals  (30000/10:£42), which attempted to show that
lindane does not cause blood dyscrasias  in  humans, could not  be evaluated
because supporting data  were either absent  or  insufficient.  In addition,
however, Hooker submitted six studies  surveying various  human populations
for a relationship between  lindane  and blood  dyscrasias.  These six surveys
lend support to the Agency's  original  determination  that there is insuffi-
cient epidemiologic evidence to  establish such a cause-effect relationship.

               In addition  to the material  submitted by  registrants,
further data on lindane  and  blood dyscrasias  have come to the Agency's
attention since PD1 was  issued.  Specifically,  the Agency is  aware of two
in-progress epidemiological  studies in Iowa and Illinois and in Hawaii,
respectively, the first  of  which was  prompted  by a clinical incident
linking lindane and a child's blood disorder.   The case  in question
involved a 32-month-old  Illinois boy  who was  diagnosed as suffering from
aplastic anemia secondary to lindane  exposure  and led to an epidemiological
study of exposed households  in  Iowa and  Illinois by  the  Iowa
Epidemiological Study Center.
                                                                    10/
               Lindane was  present  in the child's blood at 1.6 ppb.—
Analysis of the blood of other  family members  showed the following levels
of lindane:  father, 4.9 ppb; mother,  3.1 ppb;  and sister, 8.1 ppb.  A
lindane vaporizer in the house had  been  operating continuously since 1970.
It was discovered that the  distributor of this  product sold lindane vapor-
izer crystals on a continuing basis, .servicing homes and businesses at
about 375 locations in Illinois  and Iowa during 1973.

               As a result  of these findings,  the Iowa Epidemiologic Study
Center has undertaken a  special  study of 473  people  in private homes in
Iowa and Illinois who had been  exposed to lindane in connection with hcme-
use vaporizers for varying  lengths  up to 26 years.  Because lindane is
absorbed in many exposed surfaces during vaporizer use,  then  revolatized
from these surfaces into the air, exposure  to  lindane extends beyond the
time of actual operation of  the  vaporizer.   The Agency has received some
preliminary, statistically  unchecked  results  of this study.  In the 235 •
households surveyed, 440 blood  samples were taken and analysed for lindane
and chlorinated hydrocarbons.   Approximately 70 percent  of these samples
contained lindane ranging from  1 to 46 ppb.  Air samples were taken in 10
percent of the homes, and lindane was  found in the air in every home.
 IP/ Another  recent  incident  indicative of the particular sensitivity of
    children  to  the  potential  effects  of lindane is addressed in connection
    with  acute central  nervous system  effects [Subsection II.A.4C!4)(c)
    below].   The  case  in  question involved the death of a two and one half
    month old infant who  had been treated for scabies with a commercial
    lindane  orcduct.
                                   11-21

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A total of 478 health questionnaires have also been  compiled.   Because  the
study remains to be completed, the final results of  the  Iowa  study  will be
presented in Position Document 4.

               The second epidemiological study, currently  being conducted
in Hawaii, was prompted by the occurrence of five cases  of  aplastic anemia
in Maui County (population:  approximately 50,000),  a relatively high inci-
dence given that aplastic anemia is generally considered a  rare disorder
(national mortality rate:  0.1/100,000).  The Agency has reviewed protocol
and progress reports and has telephone interviewed the Hawaii Project Direc-
tor of this study (Memo 1980a).  The 2-year study is designed to detect
blood dyscrasias associated with a wide range of organochlorine pesticides,
including lindane.  Data are being gathered on patients  with  diagnoses  of
aplastic anemia, agranulocytosis, and blood dyscrasias.  The approach of
the study is as follows:  1) to obtain lists of patients with the above-
named diagnoses, 2) to solicit statewide cooperation from all family practi-
tioners, pathologists, and hematologists, 3) to administer  questionnaires
to patients concerning pesticide usage - home and occupational  usage, and
4) to review medical records, both hospital and out-patient,  for demo-
graphic and pertinent clinical data.  The results of this study will not be
available until the end of the 1980 calendar year, and the  Agency is at
this time unable to judge whether or not the study will  prove useful in
terms of establishing or disproving a causal relationship between lindane
and blood dyscrasias.  The Agency has been advised,  however, that "there is
no evidence which focuses attention on lindane at this time."   The  final
results of the Hawaii epidemiology study will be presented  and  evaluated
together with the results of the Iowa study in Position  Document 4.

               Taking into account all currently available  data,  the Agency
must reaffirm its original position that insufficient evidence  exists to
firmly establish a cause-effect relationship between lindane exposure and
blood dyscrasias.  The Agency points out, however, that  the epidemiological
data submitted do not satisfactorily answer the very complex question of
whether the hematopoietic tissues of certain individuals, particularly  chil-
dren, might be peculiarly sensitive to lindane.

          c.   Comments Submitted and Agency Findings on Possible Adverse
               Effects;  Acute Hazards to Humans and Domestic Animals

               In Position Document 1, the Agency cited  99  health-related
incidents recorded by the SPA Pesticide Episode Reports  System  (P2KS) be-
tween 1966 and 15 June  1976 which implicated products containing lindane.
In that connection registrants were requested to submit  any data they might
have on the acute toxicities, both dermal and inhalational, of  their lin-
dane products, including products formulated with other  active  ingredients.—
 11/  "Episodes"  include all association with  a  given  pesticide  and do  not
     always imply ingestion.  The PSRS data do  not  necessarily  include all
     incidents which have occurred during  the given time  span.
                                    11-22

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Eighty-four of the incidents cited in PD1 involved humans,  and  the  majority
of these occurred in the home.  Fifteen involved domestic  animals.   Of the
84  human incidents, 49 involved lindane as a sole active  ingredient,  and
35 listed lindane in combination with another active  ingredient.  The  major-
ity of the lindane-only cases involved children (in 24 cases  the  child
ingested the pesticide) and half of the lindane-only  episodes led to clinic-
al symptoms. Hospitalization followed by death occurred  in five of  the epi-
sodes.  The majority of the incidents attributed to lindane in  combination
with another pesticide involved adults.  Clinical symptoms were cited  in
less than half of these episodes, and two cases resulted in death.
Fifteen livestock or domestic pet incidents were reported,  nine involving
lindane as a sole active ingredient and six involving lindane in
combination with another active ingredient.

               The submissions received during the rebuttal period  are
addressed in Subsections (1) through (3) below.  These comments did not
mitigate the Agency's concerns over lindane exposure.  In  addition  to  the
studies submitted by registrants and in addition to the  evidence  which was
cited in PD1, data have come to the Agency's attention which show that
exposure to lindane, both in test animals and in humans, can cause  adverse
effects manifest in particular as symptoms of central nervous system (CNS)
stimulation.  In this connection there is evidence also  to suggest  that
children are especially sensitive to the acute toxic  effects of lindane.
Additional Agency findings concerning the acute effects  of lindane  as  a CMS
stimulant are presented in Subsection (4) below.  The Agency's  assessment
of the acute and subacute toxic risk of lindane is given in Subsection
II.C.3.

               (1)  Acute Hazards;  Studies Submitted on Inhalation
                    Toxicity

                    Two registrants, Chevron Chemical Co.  and Reed  and
Carnrick Pharmaceuticals, submitted -data intended to  demonstrate  that
lindane poses no acute inhalation toxicity.  Chevron  (30000/10:£38)
submitted a study in which groups of five male and five  female  Sprague-
Dawley rats were each exposed for one hour to about 50 ing/liter vapor  and
75 mg/liter aerosol of a commercial lindane product.   Although  the  animals
were ataxic after one hour of exposure to the vapor,  they  recovered within
24 hours.  No toxicity or deaths resulted from exposure  to the  aerosol.
Test rats in both groups showed weight gains comparable  to controls.  At
autopsy, no gross pathological changes were attributable to lindane.  This
study has been reviewed by the Agency  (SPA  1973c).  The  exposure  chamber
("tunnel chamber") was neither described nor referenced  to existing litera-
ture.  Mo data were given on  uniformity of distribution  of the  test
material, chamber temperature, humidity, or handling  conditions of  the
animals.  No raw data  to substantiate the study's  findings were provided.

                    In an effort to show that  lindane presents  no respira-
tory hazard, Reed and Carnrick  (30000/10: =?6C)  submitted  an acute  inhalation
toxicity  study  in rats.  Five male and five  female adult rats were  exposed
for one hour in  a 40-liter glass chamber to  a  concentration of  12.3 ng
lindane/liter  [sic, Agency calculation =  14.4 mg/liter].  No toxicity
                                  11-23

-------
or positive pathological findings were observed after  the  14-day  observa-
tion period.  The Agency has reviewed this study and considers it invalid
(SPA 1978c) for the following reasons.  The chamber, the generating  system,
and the exposure conditions were not adequately described.  Nor did  the
authors state whether the (undescribed) atomizer, used to  introduce  the
test material into the chamber, produced respirable particles.  Data given
in the study do not provide information on the LC_fl dose-response.

                (2)  Acute Hazards:  Studies Submitted  on Dermal Toxicity

                    Two registrants, Reed and Camrick Pharmaceuticals and
Chevron Chemical Co.,  submitted a total of five studies on the dermal toxi-
city of lindane.  Reed and Carnrick (30000/10 :#6C) submitted  four studies
on lindane as a scabies treatment.  Three of the studies, Woolridge  (1948),
Halpern et al.  (1950), and Xorneblee and Combes (no date), involved  human
patients, none of whom experienced side effects when treated  with lotion
formulations containing from 0.15 percent to  1 percent lindane.   The fourth
study, Mohrmann (1976), involved rats which were treated with a commercial
lindane-formulated lotion sold for human use.  At autopsy, none of the rats
showed gross pathological effects.  The Agency has evaluated  these studies
(EPA, 1978c).  Two of the studies performed on human patients, Halpern et
al. (1950) and Woolridge (1948) were found valid.  The third  epidemic-
logical study, Xorneblee and Combes (undated), provided insufficient data
for Agency validation.  The fourth study, Mohrmann (1976)  on  rats, was
likewise found valid  (SPA, 197Sc).
                    Chevron Chemical Co. .(30000/10:138) submitted  a  study
on the dermal toxicity of a commercial lindane spray product  to  adult male
rabbits showing an H>50 of 922 mg. a.i./kg.  The Agency has reviewed this
study and considers it valid  (SPA  1978c).
                    In addition to the five studies outlined above,  the
Agency received from Hooker Chemicals  (30000/10:*42C) a tabulation of  data
for acute toxicity in rats, primary skin irritation in rabbits, and  primary
irritation of rabbit eye mucosa.  Because experimental procedures were not
included, the Agency was unable to determine the validity of these data.
However, the EPA scientists who reviewed the material noted that  it  was  "in
general agreement with other similar studies"  (SPA  1978c).

               (3)  Acute  Hazards;  Studies Submitted on Oral  and
                    Intraperitoneal Toxicity

                    Hooker Chemicals (30000/10:*42C) submitted a  study on
acute toxicity in rats following oral  and intraperitoneal administration of
lindane.  Sats were incubated with aqueous suspensions of lindane at doses
ranging from 64 to 400 mg/kg, and intraperitoneally injected with aqueous
suspensions of lindane at  doses ranging from 32 to  125 ag/kg.   The Agency
has reviewed this study and considers  it valid  (SPA 1973c).  The U-0  for
both exposure routes was determined for days  1, 7,  and  14 after applica-
tion.  The I"3-n for intraperitioneal injections was 69 mg/kg for  all
three days; for incubation, the I
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               (4)  Acute Hazards:  Additional Agency Findings Concerning
                    Central Nervous System Stimulation

                    Since the publication of  the  lindane  RPAR notice and
PD1, additional data have come to the Agency's attention  which show that
exposure to lindane, in humans and in laboratory  animals,  can cause symp-
toms of acute poisoning which are typical of  central  nervous  system (CMS)
stimulation.  See Table II-5.

                    Peripheral nervous  system involvement is  described in
studies by Dallemagne et al.  (1950), White and Larrabee (1973),  and Schwarz
and Xaschowitz (1968).  These studies describe degeneration of neurons,
acting as a sympathetic ganglionic blocking agent,  and lowered excitability
of the retina from exposure to lindane  (Memo  Undated  b).   Studies by St.
Ctoer (1971) and Desi (1974) also showed CSS involvement leading to
seizures, convulsions, and learning impairment.—

                    Symptoms  in the animals appear  in the following order:
1) increased respiratory rate, 2) restlessness, 3)  intermittent muscle
spasma, 4) salivation, 5) disequilibrium, 6)  convulsions, 7)  collapse, and
8) death.

                    Symptoms  of acute human poisoning are similar to those
displayed by laboratory animals and appear in this  order:   1) dizziness, 2)
headache, 3) nausea and vomiting, 4) diarrhea, 5) tremors, 6) weakness, 7)
convulsions, 8) dyspnea, 9) cyanosis, and 10) circulatory collapse.  When
tested in humans, the following results were  obtained with the 100 percent
gamma isoner (Hayes, 1963):   40 mg/day  (.66 mg/kg/day) x 14 days - no
effect; 4.5 me three times daily x 3 days  (2.3 mg/kg/day)  - no effect;  180
mg/day repeated  (3 mg/kg/day) - dizziness  and diarrhea after several days.

               (5)  Heightened Susceptibility of  Children to Lindane
                    Poisoning
                    The Agency is  concerned in particular about the
                    f»  to  rsror?ii^f> ar-iira  af-Fpff <5 in  f-hi 1 r'-'-pn .—  fl<5
potential for  lindane  to produce  acute  effects  in children,—  as
12/
—   While not directly demonstrating  effects  to the CNS,  Xoransky and
     Ullberg  (1964) demonstrated  that  lindane  was  distributed in the CMS 24
     hours'after administration.   The  radioactive lindane  used in this study
     was  found almost  exclusively  in brain  structures containing white  •
     marker  (Memo Undated  b).

     In a  second study, Litterst  and Miller (1975),  after  50 minutes i.v.
     infusion of lindane in  dogs,  found  lindane  in the white matter and, to
     a lesser degree,  in grey  brain natter. These studies add significant
     weight  to the  reported  CNS effects.
13/
—   Even  though it may not  meet  the acute  toxicity trigger, this
     risk  factor is being  treated  by the  Agency  as part of the regulatory
     ecuaticn.
                                   11-25

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                    Tnltlu 11-5.  Acute Eltevtat  Summary of Human, ami  Aninal  Sfcutllaa on I.tlitlune an • Control  Itorvoua fiyaten Otlamlant
Aii 1 ma la Ihnana
Rofotencua Bpccloa
IHiul (I9M) NlaLar n
Dooatje Roaulta References Doauye
2.S ng/kg/day After 22 daya, docreascd llayoa. (1963) (1O-30%)
lleaulta
Approximate equivalent of
                   rata, mile    x 4O daya
                   ami fuiaala
                                 5 *>9/kg/day
                                 • 40 daya
 I
ro
en
                                 1O MU/kg/day
                                 • 40 day<*
                                 SO Itg/kg/day
                                 • 40 tlaya
|>er (omidiica on • Sklnnoc
IXJK focJIixj teat was
noted (due to tncroaaeil
Irrltalilllty).  Ik) other
changes wore noteJ.

Decreased |>ar[omaiioa
In Bkliinur box touta
aixl ware tunning teat*.
Ellqlit Inoreaaa In
kldnoy weight and Dome
brain honorrlimjo noted
at autopsy.

Aa at S
Ikiuieaoed body weight
gain tote,  eplecn
eiilargtiitcnt, and .
Increaned liver
wolghtu notoil at
autoiiay - greatly
decreased |>erCornanca
In Eklnner  tax and
• ace tuniiliKj teat a.
4O ing/day x 10 daya
(oral)
(60-05*)
40 ing/day * 14 days
(oral)

110 ing/day
repeated  (oral)
(loot)
40 ing/day * 14 daya
(oral)

45 mg 3 tlmea
dally x 3 daya
(oral)

10O mg/day repeated
(oral)
                        O.7 Mj/kg/day yielded dlarrluia
                        after Otli day
                        Approximate equivalent  of
                        O.7 »g/kg/day yielded no
                        observed effeot

                        A|>proBli»attt equivalent  of
                        1.9 mg/kg/day yielded diarrhea
                        attar Cth day

                        Approiiliaata eijulvalent  of
                        0.7 «K|/kg/day yielded no
                        observed effect

                        Approximate equivalent  9 I
                        2 mg/kg/day ylolJuJ no
                        obaurvod effeot
                                                                                                                                     te  equivalent of
                                                                                                                           3 pig/hg/day  yielded
                                                                                                                           dlexlneaa and diarrhea
                                                                                                                           after aeveral daya

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                               Tablo 11-5.  taute effuctai   fiumnary of Human aikl Aiilnal  Btuillea on Llndane as a Central  Narvou» By a tea Btinulant (Cont.)
           IU:furcncca
      Ail I ma la
Bpeclea
                                                                                                                         lltunana
Donoija
                                                                     Rasulta
                                                                                               References
Douogo
                                                                                                                                                    Results
          6t:hwurz  and         2 epeulea of  3 mij/anlnal
          Kuucliowltz  (19CO)   crcHja
M
M
 I
          White  un.l           Mult, female In vitro
          l^rralx:u  (1973)     Chnrlea River Tncubutlon
                              rats          of ganglia
                              HeauureiuoiitB of  flicker
                              fusion freqiiunclea  111
                              ait electloretliioyrom
                              nhoweJ tl>nt lliiJana
                              decreaacJ tho efflcluncy
                              of the vlaual process
                              at different llylit
                              Inteitaltlea uixl  colors.
                              CHS excitability waa
                              confirmed by accun|>aiiy-
                              lucj Increaaua In arapll-
                              tudco of reo|H>naea  In
                              tliuue teata.  (Eenol-
                              tlvlty of the nurveo
                              Inureaoed but efficiency
                              or apeetl decrvaaed) .

                              Action potential In
                              |>out
-------
                             Table 11-5.  Acute Effectsi  Summary  of  Hunan and Animal Studlea on  Llndano aa a Central Hervouu  By8tea Stimulant  (Coiit.)

Koferuncva
lldiilped
Iliuaana
Reaulta Rnforenceo Dooaqu Rcoulta

2 of 4 anlntalu allowed
Increaaed excitability.
There were no death* or
convulalona.
M
M
 I
to
CX)
              - aliaved
Hcanllng nala 60
Now Zealand   - eliavcd,
                                            strl|>[>cd

                                          - ahavcd,
                                            d«|i Hated
Ha oliuervcd effecta

Excitement In all| 4  of
6 died.
                                 Excitement In all
                                 anliualai OO» death.
                                                            EKCltunvnt  and ccuivul-
                                                            sI on  In 2 of 6t  no
                                                            duatha.
                  uitd
                            female rata   l.p.
                                 Icijoutlon of 20O
                                 with 14C-UHC allowed
                                 clear localization In
                                 brain whltu matter
                                 (after 24 huurn), and
                                 In Hoctloiis rich In
                                 nyelln fllxira.

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                            Table 11-5.  Auiita CffeutBi  nummary of Human and  Animal Utudlea on l.lndana aii • Central  llervouo By at on Utlmulant (Cont.)
 I
K)
VD

deferences
I.I It ei at ami
Mlllor (19/5)









Aiilnata
Epeclea Douacjo
Hale beagle (l.v.)
docjB 2.4 My/kg
wllli of
without |iru-
treatment
with |i|ioiio-
barbltal






ItiuaaiiB
Peotilta ' ItoCerencea Dooaga Itouulto
Ilia vtudy ahowetl
l'i«f eroiitlal aautum-
latloit In liralu
ntcuuturuu - white
natter. PcetreaUneiit
(6O day>) with
15 my/kij/doy |>liuno-
barbltal duciuaaoj
luvolu of llndano In
lira In (no cliaixjo in
blood lovulat and
dtiureased event* of
eulxure.
        St.  (Ha
        (19/01
Female rate    (i.v.)
anntholcKjy
otudy revealed ohangea
lit liver, nuucle,
kidney and narve
tleaue.  Harkod  narve
degeneration waa noted
and ayna|iuee were nout
vulnerable.

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there is a significant possibility that children are more  sensitive to  the
toxic effects of lindane than adults.  Although limited data  are  available
at the present time to establish that children display an  increased
sensitivity to lindane, it is believed that pubescent children  are  likely
to have a heightened susceptibility to harm from pesticide exposure in
general.  Some of the factors likely to make pubescent children more
susceptible than adults to the toxic effects of pesticides include  the
"greater uptake of (pesticides) in the developing tissue and  organ  systems
of younger aged children", "increased susceptibility to asthma",  "increased
susceptibility to agents that interfere with calcium metabolism", "increa-
sed susceptibility to agents that interfere with protein utilization",  and
"increased sensitivity to hormonal imbalances."  (Memorandum  from Peter F.
Infante, Director, Office of Carcinogen Identification and Classification,
OSHA, to Grover Wran, Director, Health Standards Program,  OSHA  (June 16,
1978), cited in National Association of Farmworkers Organizations,  et al. v.
Ray Marshall, U.S. Court of Appeals, D.C. Civil Action No. 79-1044). On
the basis of similar developmental factors, prepubescent children would
also be expected to display a greater sensitivity to pesticides.  Moreover,
the potentially higher exposure per unit of body weight for young children
and the possibility of underdeveloped detoxification systems  in very young
children would also appear to pose significant concerns.

                    Furthermore, the Agency's concern about the suscepti-
bility of children is supported by both animal data on the effects  of
lindane and clinical cases of lindane poisoning in children.

                    An experiment with rabbits showed that immature animals
display a very pronounced sensitivity to lindane compared  to  adult  animals.
Hanig et al. (1976) treated rabbits with a single topical  application of  1
percent lindane at 60 mg/kg.  Young adult (2 to 3 kg) and  just-weaned
(6-week-old) male New Zealand rabbits were either shaved;  shaved  and
depilated; or shaved, depilated, and "stripped" with adhesive tape.   The
animals were observed for three weeks.  Fifty percent of the  young  adults
that had been shaved, depilated, and stripped showed only  mild  excitement
after treatment.  Treated weanling groups, however, showed severe CNS
symptoms of excitement, convulsions (all groups), and death (50 to  70
percent of the animals) if the skin was depilated and stripped.   The Agency
has reviewed this study and has concluded that the data presented
support its concern that children may be more sensitive than  adults  to  the
acute toxic effects of lindane.—
14/
—   The weanling controls which were shaved, depilated  and  stripped
     did not exhibit excitement or convulsions but did suffer  a  high
     mortality rate.  The authors concluded that  the  stripping process  was
     too severe for the weanling rabbits and that the high mortality  rate
     of the controls did not negate  the high incidence of excitement  and
     convulsions in the treated orouo.
                                  11-30

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                    A number of clinical cases of  lindane  poisoning in
children also heighten the Agency's concern about  the  special  sensitivity
of children to the acute effects of lindane.  One  case  which  illustrates
the significance of lindane's potential to produce acute effects  of the
central nervous system involved the recent death of  a  two  and  one half
month old infant who had been treated for scabies  with  a commercial lindane
product.  Lindane was found in the child's heart blood  at  33 ppb, in the
urine at 2 ppb, and in the brain tissue at 100 ppb.  Doctors who  reviewed
the case at the University of Miami Epi-Studies Pesticides Laboratory
agreed that the concentration of lindane in the brain  at a level  three
times higher than in the blood was.the most probable cause of  death
(University of Miami Memo, 1979). —

                    In view of the potential of heightened sensitivity of
children to pesticide exposure, a cautious approach  is  warranted  toward
setting margins of safety levels for children exposed  to lindane.  Current
scientific information is, in the Agency's judgment, insufficient to set
separate margins of safety levels for children.  The most  that can be said
is that the margin of safety figures for adults are  probably  too  high to
assure the safety of children.

                    a.   Comments Submitted on Possible Adverse Effects:
                         Population  Reduction  in  Nontarget Avian Species

                         The Agency  cited  studies in  the  lindane RPAR
notice which showed that exposure to DDT and its  metabolite,  DDE,  caused
eggshell thinning in wild birds.  The Agency was  concerned that lindane (an
organochlorine pesticide like DDT) might adversely affect populations of
nontarget avian species.  In addition, a study on lindane's effects on
chicken eggs was cited which showed  that lindane  reduced  hatchability and
reproductive efficiency.  However, the Agency  considered  these data
insufficient to initiate a rebuttable presumption.

                         No comments were  submitted in rebuttal to this
concern.  The Environmental Defense  Fund  (30000/10 : #43)  suggested that
exposure of lindane to avian species should be considered.  The Agency has
reviewed this concern  (Memo, 1977) and has concluded  that there is no new
evidence showing adverse effects on  avian  species and that there is little
evidential basis for concern.   Because chickens are not representative of
wild avians, no determination that lindane adversely  affects  nontarget
avian species can be made on the basis of  the  chicken study cited in the
     notice.
 —  Because  it  involves  a  child,  the  example  of  this  infant death
 attributable  to  the CMS  effects of  lindane  warrants  comparison with the
 recent  case  of  a 32-month-old  Illinois  boy  who was  diagnosed as suffering
 from  aplastic^nemia secondary  to  lindane  exposure  from a vaporizer used in
 his home.  Refer to Subsection IV.  A. 4.b above  regarding blcod dyscrasias
 as a  cossible adverse  effect of exposure  to lindane.
                                    11-31

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                    b.   Comments Submitted and Additional  Agency Findings
                       •  on Isomerization

                         In Position Document  1 the Agency  citad studies
which suggested that lindane (gamma-BHC) may isomerize  in the  environment
to alpha-BHC, and in rats to alpha- and beta-3HC.  The  question  of isomeri-
zation was raised as a potential concern based on  data  establishing that
the alpha and beta isomers of SHC induce statistically  significant onco-
genic changes in seven different rat and mouse strains.  Three registrants,
Hooker Chemical Co. (30000/10:#42), Franklin Laboratories (30000/10:237),
and Paper Products, Inc.  (30000/10:341) commented  on  the issue of
isomerization.

                         The most extensive comments  were submitted by
Hooker Chemical Co. and these may be summarized as follows:

                         1)   Chemical-driving forces favor degradation of
lindane, not isomerization.

                         2)   Isomerization of gamma-BHC to alpha-BHC
apparently takes place in sediments, but to such a low  extent  that it is
not of significance for the environment.

                         3)   The fact  that many research articles have
reported degradation but not isomerization, and that  the one article which
did report isomerization of grass (Steinwandter, 1975a) used conditions in
which substantial microbial populations were present, render it  unlikely
that isomerization takes place in plants to any considerable extent.  The
results of the Steinwandter study may also not be  reproducible.

                         4)   The Kamada (1971) rat study,  cited in ?D1,  is
deficient in several respects (enumerated below),  and isomerization in rats
is very doubtful.

                              a)    The  analysis of the  rat  tissues was
carried out by gas chrcmatography using only one column.

                              b)    There were  only two  animals in the
control group.

                              c)    In the livers of the control  animals
beta-3KC was found in rather high concentrations.

                              d)    A comparison of the  data from the rats
treated with beta-3HC with the data from the control  animals could be
interpreted to indicate that beta-3HC is also  isomerized to alpha-3HC.

                              e)    No detailed information  is  given about
the gas chroiaatographic determination of the purity of  the  isomers used.
Although it is stated that in each  acrive ingredient  only one  isomer was
detectable,  it is Itncwn that traces of  other isomers  are generally also
present.
                                11-32

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                              f)   No details about the  contamination of
the feed and oil used are given.  Oils in particular very  often  contain
different amounts of organochlorine substances such as BHC isomers.

                              g)   The appearance of the various isomers
which were not administered in comparison to the values  from  the controls
cannot be regarded as significant, and the appearance of these isomers as  a
result of isomerization is very doubtful.

                              Franklin Laboratories (30000/10:$37)  and
Paper Products, Inc. (30000/10:*41) pointed out additionally  1)  that  the
formation of alpha-3HC from an intermediate benzene tatrachloride is
difficult to visualize since two chlorines would have to be added back to
the molecule in the process, and 2) that because of apparent  contamination
of the food fed to the rats, it is difficult to interpret  Kamada's  work.

                              The Agency's response to these  collective
comments is presented in Subsections  1) through 4) below.   The discussion
also includes other information received by the Agency since  the
publication of PD1.

                              1)   Chemical Driving Forces

                                   Although, as noted in PD1, the relative
thermodynamic stabilities of the four major BHC isomers  are in the  order
gamma
-------
                                   The  studies  by the Matsumura group also
reported the formation of small amounts of  alpha-3KC from the microbial
degradation of lindane.  In  these  studies Pseudomonas putida was cultured
in the presence of   C-labeled lindane, together  with various cofactors.
When nicotine adenine dinucleotide (NAD) was  present in the culture, 3
percent of alpha-BKC was reported  as  a  metabolite after 20 days incubation.
In this case 73,5 percent of  the original radioactivity was recovered as
lindane.  Without NAD, or in  the presence of  many other cofactors,  no alpha-
BHC was reported.  Very little degradation  proceeded under these conditions.

                                   Hooker's comment on these studies did
not dispute the formation of  the alpha-iscmer,  but instead concluded, based
on the low yields of this isomer and  much higher  yields of other
degradation products, that "the isomerization of  gamma-3HC in the
environment is not of significance for  the  environment."

                                   A  number of  additional studies on the
microbial degradation of lindane have been  published since PD 1.  A brief
survey of the more important  studies  follows.   Kohli et al. (1976)  de-
scribed several radio labeling studies  of lindane degradation in hydroponic
lettuce cultures.  After four weeks under aerobic conditions, 78 percent of
the total radioactivity was  lost through evaporation, 17.3 percent was
recovered as unchanged lindane, and the rest  consisted of chlorobenzene
metabolites, including hexachlorobenzene, and chlorinated phenols.   These
metabolites were identified  by gas chromatographic and mass spectral com-
parison with authentic materials.  No  alpha-3HC  was reported.

                                   Tu (1976)  reported the presence  of a
large number of lindane metabolites fron several  bacterial and fungal
cultures.  Chlorocyclchexenes and  chlorobenzenes  predominated, but
quantitative results were not reported.

                                   Heritage and MacRae (1977) reported the
degradation of both  lindane  and alpha-3HC by  Clostridium sphenoides under
anaerobic conditions.  In cell suspensions  of this soil bacterium,  the
ganana- and alpha isomers typically disappeared  after two and four hours,
respectively.  Tetrachlorccyclohexenes  were identified as intermediates by
gas chromatography and mass  spectrography.  Alpha-3HC formation from the
lindane-inoculated culture was not reported.

                                   Mathur and Sana (1977) studied the
degradation of radiolabeled  lindane by  soil bacteria under both aerobic and
anaerobic conditions.  After  eight weeks  incubation, 70-86 percent of the
  C-radioactivity was  recovered as lindane  from the anaerobic cultures.
The principal metabolites were di- and  tri-chlorobenzenes and tezra- and
pentachlorocyclohexer.es, and no alpha-3HC was reported.
                                  11-34

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                                   Kohnen et al.-j£1975) measured  the
release of chloride ion and carbon dioxide from   Cl- or  '"*C-labeled
lindane in submerged (anaerobic) and moist (aerobic) soil  cultures.   Under
anaerobic conditions, 86.5 percent of total chlorine was liberated  as
chloride ion in 52 days, while only 6 percent of total  carbon  was liberated
as   CO  in 77 days.  The amount of isomerization to alpha-3HC was
stated to be 1.1 percent, but no experimental details were given.   3y
comparison, under aerobic conditions only 9 percent of  total chlorine and 3
percent of total carbon were liberated in 105 days.

                                   In a  later study by  the same authors
(Jagnow et al., 1977), a survey of bacterial cultures showed that 7-93
percent of total chlorine was released as chloride ion  from lindane under
anaerobic conditions.  No data on the isomerization of  lindane were pre-
sented. However, the following statement was made:  "It cannot yet  be
decided, whether these HCH-isomers were  formed by isomerization of  gamcia-
HCH during incubation, or if they were already present  in  the  gamma-HCH
preparation and became relatively enriched during the degradation of  the
gamma-HCH."

                                   Engst et al.  (1979)  studied the  anaero-
bic degradation of lindane by a mixed culture of bacteria  and  reported the
transitory appearance of alpha-3HC during 39 days of incubation.   The
highest ratio of alpha-BHC to lindane was 2.3 percent after about six days.
Much lower levels of alpha-BHC, as well  as even  lower levels  (not speci-
fied) of the delta- and beta-isomers, were indicated during later stages of
the incubation.  Pentachlorocyclo'nexene, tetrachlorobenzene, and  unknown
polar metabolites were also reported, but no yield data were given.

                                   It seems reasonable  to  generalize  from
all of these studies on the microbial degradation of lindane  that the major
pathway of degradation involves dechlorination rather than iscmerization.
Metabolites of  lindane containing fewer  chlorine atoms  are consistently
reported.  Moreover, the disappearance of lindane by volatilization,
together with the appearance of chloride ion, strongly  suggests that
extensive  degradation of lindane to lower molecular weight substances,
including  carbon dioxide, occurs in most cases.  Several  research groups
have identified alpha-3HC and hexachlorobenzene  as minor  metabolites, but
the extent of production of these metabolites appears to  be no more than a
few percent at  best, and under most conditions they apparently are not
detectable.  Because the isomerization of lindane appears  to  require
anaerobic  conditions, which are generally sequestered  from efficient
exchange with the aerobic environment, and because alpha-3HC also appears
to be  degraded  under anaerobic conditions, the comment  by Hooker  Chemical
Co.  that the microbial  isomerization  is  not  significant is accepted by the
Agency.
                                   11-35

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                              3)   Isomerization  in  Plants

                                   A study by  Steinwandter  (1976a),  in
which isomerization of lindane to alpha-BHC  in plants  was reported,  was
cited by Hooksr Chemical Co. during the rebuttal  period  though it was not
mentioned by the Agency in ?D1.  In this  study, lindane  was converted to
alpha-BHC after application to hay for six months.   At the  end of the
experiment, the hay had decayed and was densely colonized by microbial
growth.  In comparison to the control sample,  which  had  0.018 ppm of alpha-
BHC, the created sample had 0.043 pom of  the alpha-isomer.   Since the hay
had been treated with 2.5 ppm of lindane, the  formal yield  of alpha-BHC was
about 1 percent.  In a communication to Hooker Chemical  Co., Steinwandter
(1976b) stated that he was unsure whether he could reproduce these results.

                                   Since  the publication of PD1,
Steinwandter has published additional studies,  in which  the formation of
beta-BHC from alpha-BHC at an apparent yield of about  2  percent was  claimed
(Steinwandter, 1978a), and which presented some crude  rate  data on the iso-
merization process (Steinwandter, 1978b).  These  reports have similar dif-
ficulties with contamination of experimental material  and present only
minimal additional evidence.  The data (Stsinwandter,  1978b) appear  to show
that: alpha-BHC is formed rapidly but also is degraded  rapidly.   No data are
presented concerning the fate of the approximately 98  percent of the
lindane that did not isomerize to alpha-BHC.   The resolution of peaks in
the chromatograms presented is not adequate  to allow unequivocal
identification and quantification of alpha-BHC.

                                   The validity of the conclusion that
lindane is isomerized to alpha-BHC in plants is questionable because of the
contamination of experimental materials by the HKC isomers, because  of the
presence of the dense microbial growth in the  materials, and because of the
lack of adequate analytical detail.  Since the yields  of alpha-BHC,  beta-
BHC, and HC3 are at best low  (1-2 percent),  the Agency must conclude that
isomerization of lindane to its isomers does not  take  place to any
appreciable extent.

                              4}   Isomerization  in  Rats

                                   The Agency  cited  in PD1  a study by
Xamada  (1971) in which each of the four 3HC  isomers  were fed for one week
to  separate groups of four rats each.  Blood,  urine, liver, and kidneys
were then analyzed for each of the isomers.  A fifth group  of four rats was
included as a control.  Kamada reported levels of beta-3HC  in the livers in
excess  of control levels when the rats were  fed either alpha-BHC or gaimna-
3HC.   He concluded that these isomers may be isomerized  to  beta-3HC by the
rat.
                                  11-36

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                                   A number of deficiencies  in  this  study
(listed earlier) have been pointed out by Hooker Chemical  Co.   These points
are generally correct.  In fact the rats in the control  group had  high
levels of alpha-3HC (0.05 ppm), beta-3HC (.02 ppm),  and  gamma -3HC (0.15-
0.16 ppm) in the liver, as well as extremely high  levels of  alpha-SHC and
especially gamma-3HC  (4.3 ppm) in the kidneys.  Chadwick  (1976)  also
pointed out some of the same deficiencies and argued that  it is difficult
to interpret the results of the study.

                                   The Agency contacted  Dr.  Xamada in 1973
and obtained the following additional information  (Kamada,  1978):

                                   1)   The 3HC isomers  used in the  study
had the following purity: alpha-BHC, 99 percent; beta-3HC, 99.7 percent;
gamma-BHC, 99 percent; and delta-3HC, 99 percent.  Peaks of  other  isomers
were not observed on  gas chromatograms.

                                   2)   The commercially sold feed fed to
rats was contaminated with gamma- and alpha-3HC, as  well as  with much lower
levels of beta-BHC.   Exact records of this data are  no  longer available.

                                   3)   No attempt was made  to  measure
other lindane metabolites in the rat tissues.

                                   In an attempt to  reproduce the  results
of Xamada, Sichler and Heupt  (1977) fed lindane of 99.95 percent purity to
29 rats for eight weeks.  They found 767 ppm of lindane  in the  kidneys but
only 0.047 ppm of alpha-BHC, which is less than the  amount of the  alpha-
isomer expected on the basis of the measured impurity.   No alpha-3HC was
found in the liver at a detection limit of 0.002 ppm.   A research  group at
CIEL in Germany is presently carrying out additional studies on the
possibility of lindane isomerization in rats.  No  data  are as yet  available
to the Agency.

                                   Copeland and Chadwick (1979) treated
groups of weanling rats with  several different levels of lindane over
periods of time extending to 24 weeks, followed by a single  large  oral dose
24 hours before sacrifice.  They reported that the levels  of alpha-3KC in
the livers did not exceed levels which would be expected on  the basis of
the alpha-SHC consumed as an  impurity, and concluded that  bi-oisomerization
does not play a significant role in the metabolism of  lindane by the rat.

                                   3ased on the totality of  information
available on the metabolism of  lindane by rats  (e.g. Zngst et al., 1976),
on the failure cf other  research groups to reproduce the results of  the
original Kamada study, and on  the problems of  contamination  in  that  study,
the Agency concludes  that isomerization of lindane to  its  isomers  in rats
has not  been established.
                                  11-37

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     3.   Exposure Analysis

          1.    Persistence and Exposure

               A persistent pesticide provides a greater  opportunity for
exposure than a non-persistent pesticide.  Since pesticidal  risk  is  a func-
tion of exposure and toxicity, it follows, all else being equal,  that a
persistent pesticide presents a higher risk potential  than a non-persistent
pesticide.  Lindane, as we show below, is a persistent pesticide.

               As discussed in Position Document 1, lindane  is  a  member of
a class of organochlorine pesticides, which, as a  rule, are  more  persistent
in the environment than-other classes of pesticide compounds.   This
persistence is due largely to the chemical stability of the  organochlorine
compounds and their slow degradation by plant and  animal  enzymatic  systems.
Lindane is quite mobile in the environment.  Residues  of  lindane  have been
detected in all types of environmental media, including water,  air  and soil
samples, homes, and plant and animal tissues.  The presence  of  lindane
residues at sites far removed from its application attests in particular to
the long term persistence of the pesticide.  Lindane residues have  been
found, for example, in rainwater samples from several  countries (Ref. 3 s
9,?D ;M),-in birds, penguins, skuas and cormorants, fish,  Mototheria sp.
and planktonic krill in Antarctica (Tatton and Ruzicka, 1967),  and  in seals
and an arctic fox In Greenland (Clauscen, et al.,  1974).   Lindane residues
have been found at low levels in drinking water from various sources in the
United States (SPA, 1975) and in ambient air samples from selected  states.
For example,  during the years 1970 to 1972, lindane residues were found in
58% of 2,479 ambient air samples from 14 to 16 selected states;  in  1976,
lindane air levels of 2.2 ng/m  were detected in Miami, Florida;  0.3 ng/
ma  in Tort Collins, Colorado; 0.5 ng/m  in Lafayette,  Indiana;  16.2 ng/
m  in Jackson, Mississippi; and 0.4 ng/m  in Harrisburg,  Pennsylvania
(EPA, 1976b).

               The persistence of lindane in the soil  is  dependent  on a
number of factors, including soil type, soil organic matter, water  content,
soil temperature, and lindane concentration.  Although lindane  is
eliminated from the soil at a faster rate than most other chlorinated
hydrocarbon insecticides, it is still persistent when  compared  with  other
classes of pesticides.  In long-term tests of the  persistence of  lindane,
for example,  the remaining residues in soil after  a 15-year  period  ranged
from 0.2% to 3-3% of the amount of lindane applied (Lichtenstein  et  al. ,
1971 and Voerman and Besemer, 1970).  Lindane residues in soil  appear to be
fairly low; for example, in 1970, 0.4% of 1506 cropland sitas sampled had
detectable lindane residues which varied between 0.01  and 0.15  ppm.   The
primary factor responsible for the low residue levels  of  lindane  in  the
soil is the high vapor pressure of lindane which results  in  a rapid
volatilization of the compound from the soil.  This volatility  lessens the
availability of the compound for degradation by soil microbes,  but
ultimatelv contributes to the oersistence of lindane in non-soil  media.
                                II-33

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               Lindane has been found in the body,  organs  and tissues of
mammalian, avian and aquatic species with greatest  shortage  in the  body
fat.  Monitoring data show, for example, that  lindane  residues occurred in
human adipose tissue in 0.77%, 1.56% and 0.56% of the  samples collected
during 1970, 1973 and 1974.  The mean level of lindane residues in  human
adipose tissue for the years 1970 to 1974 was  less  than 0.1  ppm on  a lipid
basis (Xutz et al., 1976).

          2.   Comments Submitted on Exposure

               a.   Comments Submitted on Dietary Exposure

                    Hooker Chemicals (30000/10:342)  and Burroughs Wellcome
Co.  (30000/10:34A) submitted a total of  seven  comments on  dietary  exposure
of humans to lindane, which the Agency has evaluated (EPA  1973d).

                    Hooker Chemicals argued in general terms that  residues
of lindane in food are low.  In addition, Hooker cited FDA data which
showed that the daily intake of lindane  has dropped from 0.007 mg/kg per
day  in 1967 to 0.0000084 mg/kg per day in 1974.  Hooker also noted  that,
although  no analytical method can distinguish  between  gamma isomer
resulting from BHC or lindane use, the decline in lindane  intake follows
the  decline in the amount of BHC produced and  used  in  the  U.S. over the
years.  Burroughs cited the saae FDA data for  1973-1974 showing a  range of
lindane residues in beef from 0.0004 to  0.012  ppm.

                    The Agency agrees that  lindane  levels  in food  have
decreased.  The Agency believes, however, that if the  FDA  market survey
errs, it  is more likely to underestimate  than  overestimate residues
actually  ingested, because of FDA's method of  compositing  samples  before
chemical  analysis.  The FDA market basket survey remains the most  reliable
source of residue data available.  Since  BHC  is  no  longer  in general use,
the  Agency  considers  that  source of gamma-BHC  to be no longer pertinent. .

                    Hooker submitted data as  evidence  that lindane  residues
on vegetables and  fruit are generally lower  than 0.5 ppm.   The Agency
agrees that residues  of lindane on fruit and  vegetables are generally less
than 0.5  ppm.

                    Hooker Chemicals  (30000/10:"42) cited  a study showing
that the  application  of lindane as a  seed treatment did not result  in
detectable  lindane  levels  in  wheac, oats, and  barley.   The Agency notes
that a review of FDA's monitoring  data of whole  grain for  human consumption
showed 2.5  percent  samples positive  for  lindane  at  a mean  residue level of
<0.03 ppm (1973d).

                b.   Comments  Submitted on Exposure  Via Drinking Water

                    Hooker Chemicals  (3000/10:^42)  commented that lindane
residues  in drinking  water are  generally well  below the limit of 0.004 ug
 lindane/litsr  sec  by  EPA's Water  Supply  Division.
                                   11-39

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Table II-6.   Average Lindane Fesidues  in  Food  (by  Composite Category)
Composite
Food Category
Dairy
Products
Meat, Fish,
& Poul try
Grain and
Cereals
Potatoes
Leafy
Vegetables
Legume
Vegetables
Root
Vegetables
Garden Fruits
Fruits
Oils, Fats i
Shortening
Sugars and
Adjuncts
Beverages
Total
FDA Food
Factor
25.7%
9.0%
14.2%
6.2%
1.3%
2.3%
1, 1%
3.1%
7.4%
2.4%
2.3%
24.0%

Avg of All
Samples (ppm)
0.0027
0.0017
0,0001
Trace
0.0
0.0
Trace
0.0015
0.0
Trace
0.0029
0.0

Daily Intake In
mg/1 .9 kg diet
(70-kg adult)
0.00135
0.00030
0.00003
0.00043
0.0
0.0
0.00009
0.00009
0.0
0.00013
0.00015
0.0
0.00266
                                  11-40

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                    Most of the data cited by Hooker  on  this  issue derived
from Position Document 1.  An additional study by  Bevenue  (1971)  found only
4 percent of 45 samples taken in Hawaii positive for  lindane  in drinking
water.  (The average was 0.000.2 ug/liter.)  Another study,  Achari (1975),
found residues of 1.19 ppt in ground water (mostly wells)  in  South
Carolina.  Considering the information just cited  and the  low residues of
lindane reported in surface waters, which are more likely  to  be contami-
nated with pesticides than is drinking water, the  Agency finds it reason-
able to agree with the registrant  that lindane residues  in drinking water
are generally below 0.004 ug/liter  (EPA 1978d).

               c.   General Comments Submitted on  Exposure Via Air Intake

                    Based on data  in Position Document 1 (SPA 1977a),
Hooker Chemicals (30000/10:242) argued that normal air intake will expose
the general population to between  0.00017 and 0.0017  ug  lindane/kg per day,
or 1/1,000,000 to 1/10,000 of the World Health Organization/Food and
Agricultural Association's (WHO/FAO) acceptable daily intake  (ADI) of
0.0125 mg/kg per day.  Hooker also  argued that even the  highest lindane
levels in air are far from hazardous to humans, and that relatively high
levels of alpha-3HC in ambient air  samples could not  be  due to isomeri-
zation of lindane to alpha-3HC in  sediments followed  by  volatilization.

                    The Agency has  evaluated this  comment  (EPA 1978d).
Whereas Hooker used a respiratory  volume of 6 liters/min,  the Agency
believes a more reasonable breathing rate for light work is 23.6 liters/
min.  Based on exposure to a 60-kg  adult, the Agency  has established a
daily exposure of 0.011 ug/kg per  day, or about 1/1,000  of the ADI.   The
Agency also points out that the importance of lindane residues in air  is
their contribution to the total body burden of lindane.  The  general issue
of isomerization is addressed in Subsection II.A.4e,  wherein  the Agency
concludes that isomerization in the environment is not of  major signifi-
cance but does add to the overall  risk presented by lindane.

               d.   General Comments Submitted en  Exposure Via
                    Accumulation in Human Adipose  Tissue

                    Based on data  in Position Document 1 (EPA 1977a) ,
Hooker Chemicals (30000/10 :=r42) argued that lindane does not  accumulate in
human adipose tissue to hazardous  levels.  The registrant  also argued that
the only apparent reasons for beta-3HC in human adipose  tissue are that
large amounts of 3HC have been used in the U.S. in the past 25 years,  that
residues of beta-3HC are still common in  food, and that  beta-3HC has a
greater  tendency to store in human adipose tissue  and has  a greater half-
life  in  adipose tissue than other  3HC isomers.

                    The Agency has  reviewed these  comments (EPA 1978d).
According  to  data from EPA's Human Monitoring Programs for 1970 to 1974,
 1.1 percent of samples analyzed showed lindane residues  in human adipose
tissue averaging 0.1 ppm.  The Agency points out  that the  importance of
these residues is their contribution to the total  bodv burden of lindane.
                                   11-41

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-------
                               Table II-8.  Exposure Data:  Summary  of  Exposure Analysis — Use-by-Use
        Use
   Hardwood  Lorj£
     and  Lumber
M
 I
       Assumptions Used in Analysis
Dermal
a)  Seven ml of aqueous solution wet 2
averaye hands up to the wrist.
b)  Total surface area of two hands = 0.082m*
c)  Total skin area exposed (head, neck, and
hands) during operation = 0.294m2.
d)  Operator is exposed to cumulative dose
equivalent to single wetting of all exposed
skin.
e)  Lindane concentration in final
diluted mixture is 0.5'i (from labels).
Exposure Analysis
Estimation of Unit, Time & Exposure
Dermal
iiKj/hr
16
Respiratory
mg/hr
0.09
Exposure
Duration
hr/year
2000
Annual
Exposure
mg/year
D: 32,000*
Cohort
at
Risk
persons
2,400
                                                                                                      R:
                    Respiratory
                    a)   All  surface areas  surrounding  dipping
                    vat  are  saturated with lindane.
                    b)   Saturation vapor concentration of  lindane
                    20°C - O.Sug/1.
                    c)   Due  to open air conditions,  saturation
                    equilibrium  is not reached.
                    d)   lot  lindane saturation  represents  best
                    estimate of  air concentration.
                    e)   Adult maJe breathing  rate =  1.8 m  /hr.
                                                    Calculations;

                                                    Dermal:  7 ml or  7 g mixture x 0.5%
                                                             x 0.294/0.082  =  0.125 g/day
                                                             or 16 mg/hr.

                                                    Respiratory:  0.5 ug/1  or 0.5 iug/m3 x 0.1
                                                                  x 1.8 m3/hr = 0.09 mg/hr.
    *  I) =  Dermal
    *  K -  Respiratory

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                              Table TI-8.  Exposure Data:   Summary  of  Exposure  Analysis — Use-by-Use (Cont.)
        UtiC
i-t
M
I
                   Used in Analysis
                Exposure Analysis
                                                                         Estimation of Unit,  Time & Exposure
                                                                      Dermal    Respiratory   Exposure    Annual
                                                                                               Cohort
                                                                                                 at
                                                                         Duration	Exposure   Risk
                                                                      mg/hr
                                                            mg/hr
                    lir/year
                      ing/year   persons
    Seed treatment  Dermal
Based on Hayes (1975):
a)  One yram of lindane 25% dust formulation
can completely cover the hands  (0.082m ).
b)  Operator skin area exposed  (head, neck,
and hands) - O.294m2.
c)  Durincj iui.xi.mj operation only 20% of
1 i.ndane formulation reaches exposed skin.

Respiratory
Based on US-HEW (1974):
a)  Average lindane formulation air
concentrations surrounding drill-box
rig = 10 mg/w .
b)  Adult male breathing rate = 1.0 m^/hr.
c)  Operator spends approximately 60
minutes per day mixing seed.
                                                   180
          4.5
             1.7
       D:  306*
                                                                                                       R:  7.7*
             130,000
Calculations;

Dermal:  1 g x 25% x 0.294/0.002
         x 20% = 100 rng/hr

Respiratory:  10 mg/m3 x 25% x 1.0 m3/hr  =  4.5  mg/hr
    Avucudou
Hased on Wolfe ot al.  (1967):
a)  Spraying operations for avocados
are identical to those for other fruit
orchards.
b)  Reasonable values  for calculating
dermal and respiratory exposures are 50 and
0.1 mg/hr, respectively (Wolfe et al., 1967).
c:)  A single pest control operator treats
one average avocado farm in one day, twice a
year.
50
0.1
16
D:  000*

R:  1.6*
    * D =- Dei mo I
    A R - Kesp i fatory

-------
                               Table I.l-G.  Exposure Data;  Summary of Exposure Analysis -- Use-by-Use  (Corit.)
         Use
    Assumptions Used in Analysis
                 Exposure Analysis
     Ornamentals
       Cummer cia.'L
       App L icators
      Homeowners
M
M
Based on Wolfe et al.  (1974):
a)  Mean dermal and respiratory exposure
levels are 3.6 and 0.021 mg/hr, respectively,
as determined for ferithion spray solutions
containing 0.06% a.i. and assumes 1 hr workday.
b)  A 0.5% w/w lindane solution is used.
c)  A commercial applicator works 3-8 hours
a day for 1-15 days per year.
d)  A homeowner sprays only one hour per year.
Estimation of Unit,
Dermal Respiratory
mg/hr mq/hr
30 0.2
r
Calculations :
Dermal: 3.6 mg/hr x
Respiratory: 0.021 n
Time & Exposure
Exposure
Duration
hr/year
3-120
1
0.5
0.06 = Jl
0
nq/hr x
y 0
Cohort
Annual at
Exposure Risk
mq/year
D: 90-
3600*
R: 0.5-
22*
D: 30*
R: 0.18*
.5
.06
persons
30-1200
75,000
mg/hr
     Ciicurbi ts
Based on Staiff et al. (1975):
a)  Mean dermal and respiratory exposure
levels are 0.4 and 0.001 mg/hr, respectively,
as determined for paraquat solutions contain-
ing 0.025 w/w a.i. applied at 100 gal/acre.
b)  Spray-diluted lindane mixture contains  •
453 g of lindane in 200 gal. water per acre
(0.06% w/w).
1.9
0.005
                                                                        Calculations:
2.45
                                                                        Dermal:   0.4 mg/hr x


                                                                        Respiratory:  0.001 mg/hr x
                                                                                                       D:  4.7

                                                                                                       R:  0.01
                                               950
                                                                     0.06     200
                                                                           x  	 =  1-9  mg/hr
                                                                     0.025    100
                                                                            0.06
                                                                                                    0.025   100
                                    200
                                  x     = 0.005 mg/hr
     *  D =  Dermal
     *  It =-
              piratory

-------
                             Table It-0.  Exposure Data:  Sumiuairy of Exposure Analysis — Use-by-Use  (Cont.)
       Use
    Assumptions Used in Analysis
                  Exposure Analysis
   Christmas Trees
   (Stump--:} I ash
   and trunk)
i-1
 I
.F-
based on Wolfe et al. (1974) :
a)  Spray particle size distribution  is
similar to that involved in fenthion
treatment using direct spray for mosquito
control.
b)  Mean dermal and respiratory exposure
levels are 3.6 and 0.021 imj/hr, respectively,
as determined for fenthion spray solutions
containing 0.06% a.i.
c)  There is a seasonal correction factor
of 0.32 clue to reduction of body surface
area exposed during stump-slash treatment
in early spring.
d)  Use dilution is 0.5% w/w for stump/slash
and 0.05 for trunk.
Estimation of Unit,
Dermal
mg/hr
9.6
(iitump-
slash)
3.0
(trunk)
Respiratory
mg/hr
0.2
(stump-slash)
0.02
(trunk)
Time & Exposure Cohort
Exposure
Duration
hr/year
9 D:
R:
D:
R:
Annual at .
Exposure Risk
my/year persons
07 10,000**
(stump) *
1.8 (stump)*
27 (trunk)*
0.2 (trunk)*
Calculations;

Dermal:  3.6 mg/hr x


         3.6 mg/hr x

Respiratory:
          0.5
          0.06

          0.05
          0.06
   0.021 mg/hr x
 x  0.32  = 9.6 mg/hr (stump-
                    slash)

- = 3.0  mg/hr (trunk)

   0.5
                                                                                                  0.06
                                                                                                       = 0.2
   (Foliar)
based on Hatchelor and Walker  (1954) :
a)  Spray particle size distribution is
similar to that involved in hand-gun
pressure spraying of fruit orchards with
parathion.
b)  Mean dermal and respiratory levels are
56 and 0.2 mg/hr, respectively, as deter-
mined for parathion spray solutions contain-
ing O.OVt, a.i.
c)  Use dilution of the lindane spray is
O.OIU a.i.
90
0.3
                                                                     Calculations ;
Dermal:  56 mg/hr x
                                                                                         0.08
                                                                                         „  QC
     D:   010*
                                                                                                    R:   2.7*
               = 90 mg/hr
                                                                     Respiratory:  0.2 mg/hr  x   '    =0.3  mg/hr
   * I) - Dermal
   * l( - Ku:;pi ratory
   **Tol.cil estimated applicators, all application modes.

-------
       Use
   Pecan Orchards
n
1-4
 I
 -i i
                            Table II-O.  Exposure Data:  Summary  of  Exposure Analysis — Use-by-Use (Cont.)
    Assumptions Used in Analysis
Based on Wolfe et al. (1967):
a)  Spraying operations for pecan trees
are identical to those for other fruit
orchards.
b)  Reasonable values for calculating
dermal and respiratory exposures are 50 and
0.1 mg/hr, respectively.
c)  A single pest control, operator treats
one average pecan farm in one day, once a
year.
                  Exposure Analysis
                                                                       Estimation of Unit,  Time & Exposure	  Cohort
                                                                    Dermal    Respiratory   Exposure    Annual      at
                                                                    	Duration	Exposure   Risk
                                                                    ing/hr
50
                                                         mg/hr
                                                                                0.1
                      hr/year
           mg/year   persons
7.9
D:  395*

R:  0.8*
1200
   *  I)  ^  Dermal
   *  l<  -  Respiratory

-------
                              Table II-O.  Exposure Data:  Summary of Exposure Analysis — Use-by-Use  (Cont.)
M
I
*-
CO
        use
    forestry
.ivestock
                      Assumptions Used in Analysis
               Based on Wolfe et al.  (1974):
               a)  Mean dermal and respiratory exposure
               level of 3.6 and 0.021 mg/hr, respectively,
               as determined for fenthion spray solutions
               containing 0.06% a.i.
               b)  Use dilution for lindane is 0.5% a.i.
               c)  Applicators treat  32 trees per day,
               5 minutes each tree, 30 days a year.
Based on Wolfe et al. (1974):
a)  Operator exposure in dipping operations
is negligible compared with spray operations.
b)  Mean dermal and respiratory exposure
levels are 3.6 and 0.021 mg/hr, respectively,
as determined for fenthion spray solutions
containing 0.06% a.i.
c)  Use dilution is 0.045% a.i. for lindane.
                                                                    Exposure Analysis
                                                                        Estimation of Unit, Time & Exposure	  Cohort
                                                                     Dermal   Respiratory   Exposure    Annual      at
                                                                     	Duration	Exposure    Risk
                                                                     mg/hr
                                                                           mg/lir
                                                                        hr/year
                                  mq/year   persons
                                                                      30
                                                             0.2
                       80.1      0:  2400*   1000
                                 R:  16*
                                                                      Calculations:
                                                                      Dermal:  3.6 mg/hr x
                                                                       0.5
                                                                       0.06
                          = 30 mg/hr
                                                                      Respiratory:  0.021 x °'5  =02 mq/hr
                                                                                            0.06        y
2.7
0.02      Beef 2.09   D:  5.6*
                      R:  0.04*

          Pigs 2.39   D:  6.5*
                      R:  0.04*
                                                                 Calculations;

                                                                 Dermal:  3.6 mg/hr x


                                                                 Respiratory:  0.021 x
                                                                       .045 _
                                                                       .06

                                                                        0.04 5
                                                                        0.06
                                                                                                  2.7 mg/hr


                                                                                                  = 0.016 mg/hr
                                                                                                                30,000


                                                                                                               210,000
    * D = Dermal
    * 1< - Respiratory

-------
                               Table 11-8.  Exposure Data:  Suimnary of Exposure  Analysis  —  Use-by-Use (Cont.)
         Use
     Structures
       Applicators
M
I
       Residents
      Assumptions Used in Analysis
Based on Batchelor and Walker (1954):
a)  Dermal and respiratory exposures are
56 and 0.2 mg/hr, respectively,  as determined
tor parathion spray solutions containing
0.05'i a. i.
b)  Spraying time is one hour per home.
c)  A dilution of 0.5% lindane w/w is used.
d)  It is estimated that between 500-1,000
applicators treat 10,000 homes,  that it
takes one hour to treat one home, and that
this is done 10-20 days per year.

Baaed on USPHS Communicable Disease Center
(1952):
a)  Dermal exposure is negligible.
b)  An 05-day weighted average concentration
of l.indane in the air of a treated room is
estimated to be 0.05 ug/1.
c)  A dilution factor of 0.5 for diffusion
into untreated second story living space.
d)  A 1.2 mVlir breathing rate.
e)  Occupants are exposed 24 hours per day
for 04 days per year.
      * D - Del-mill
      * l< - Kuspiratory
                  Exposure Analysis
                                                                         Estimation  of  Unit,  Time S Exposure	  Cohort
                                                                      Dermal    Respiratory   Exposure    Annual      at
                                                                      	Duration	Exposure   Risk
                                                                      mg/hr
                                                           mg/hr
                      hr/year
           mg/year   persons
560
                                                                       Calculations:
10-20  D:  5600-
          11,200*
       R:  20-40*
                                                                                            0.5
                                                                       Dermal:   56 mg/hr  x Q '„,-  = 560 mg/hr
                                                                                                  0.5
                                                                                                  U . -*
                                                                       Respiratory:   0,2  mg/hr x Q Q^ = 2 mg/hr
           0.03
2016
R:  60*
                                                                       Calculations;

                                                                       Respiratory:   0.05 ug/1 x 0.5 x 1.2 m3/hr
                                                                                      x  1000 1/m3 =0.03 mg/hr
              500-1000
10,000
(houses)

-------
                               Table 11-0.  Exposure Data:  Summary of Exposure Analysis  —  Use-by-Use (Cout.)
                            Assumptions Used in Analysis
                                                                    Exposure Analysis
     I'i i
M
 I
ui
o
Based on Severn  (1970):
a)  There is no dermal exposure.
b)  Low concentrations of pesticide vapors
above soil surface are directly proportional
to their vapor pressures.
c)  Inhalation exposure of pineapple workers
to DiiCP was estimated  to be 13 ucj/hr.
d)  l.indane vapor pressure = 3 X 10~5mm  llg  at
20°C; that of DUCP = 0.8 mm llg at  21°C.
e)  A 11-hour work day, once a year, is  assumed.
Estimation of Unit, Time G Exposure
Dermal
mg/hr
Respiratory Exposure
Duration
mg/hr hr/year
4.9 X 10~7 14
Calculations :
Respiratory: 13 ug/hr x 3.0 x
4.9 x 10~7 mg/hr
Annual
Exposure
mg/year
6.9 X 10~6
10~5/.0 =
Cohort
at
Risk
persons
1600

-------
                          Table II-O.  Exposure Data:  Summary of Exposure Analysis  —  Use-by-Use (ConU.)
    Use
        Assumptions Used in Analysis
        Exposure Analysis
Estimation of Unit, Time & Exposure
Dermal
mcj/hr
Respiratory
mg/hr
Exposure
Duration
hr/year
Annual
Exposure
my/year
Cohort
at
Risk
persons
L'ets
  Pet Collars
a)  I.indanc is released at a constant rate
for 6-Q weeks.
b)  Lindane is incorporated into collar, not
on surface; total dermal contact by human
handling is negligible and unquantifiable.
c)  Data for 5% a.i. DDVP  (Shell Chemical
Company 1976) incorporated into cat collars
can be extrapolated for lindane.  The
concentration of DDVP in the air of a room
housing one animal wearing one 5% collar is
0.35 ug/m3.
d)  There  is no difference in the volatility
of lindane and DDVP.
e)  There  is a dilution factor of 1.0 to
account for the difference between the study
area (40 in ) and a standard living area  (480 m  )
t)  Use formulation is O.Glt a.i. lindane.
g)  Sedentary breathing rate = 1.2 nr/hr.
h)  A person would be exposed 24 hours per day,.
365 days per year.
5.1 X 10
                                                                      -6
                                                                          0760
                       R:  0.045*   ND**
                                                                 Calculations;
                                                                 Respiratory:
   0.35 ug/ni  x 0.61%/5.0% x  .1  x
   1.2 in3/hr = 0.0051 ug/hr =
   5.1 X 10~6 mg/hr
    U - Respiratory
*"* ND - Not Detennined

-------
                              Table  II-8.   Exposure  Data:   Summary of Exposure Analysis — Use-by-Use  (Cont.)
        Use
     Assumptions Used in Analysis
                  Exposure Analysis
Estimation of Unit, Time t, Exposure
Dermal
mg/hr
Respiratory
mg/hr
Exposure
Duration
hr/year
Annual
Exposure
mcj/year
Cohort
at
Risk
persons
M
I
Ul
    Dog Welsh
      Veterinarians
a)  A veterinarian exposes both hands to
dilute product 5 in in. day, 26 times a year.
b)  Final formula density = 0.85 g/ml at
10'i w/w liudane, cone. = O.OQ5 g lindane/ml,
o)  1 ml of solution can "just wet" hands.
d)  Mo respiratory exposure occurs.
0.14       -          2.17    D: 0.3*           130,000
                                                                       Calculations;

                                                                       Dermal:   8 oz  x 29.57 ml/oz x 0.005 cj/ml x
                                                                                1/22.5 gal. x 1 gal./37Q5 ml x 7 ml  x
                                                                                1000  mg/g x 5 min./60 min. =0.14 mg/hr.
      Owners          a)  No dermal  exposure  for  owners  occurs.
      (I'o:.;!--          b)  Animal  has access to  area  with volume  of
       treatment      12,OOO ft3.
       exposure)      c)  Hue of.  lindane  is 0.236 my/ml  of  final
                      solution  for post wasli  exposure.
                      d)  After towel drying, 79  ml  of wash
                      solution  is retained by small  dog;  237  ml
                      by large dog.
                      e)  When a  dog is washed, there is exposure
                      for 72 hours,  once  a year.
                      f)  Assumed dilution factor of 10  for air
                      exchange.
                      g)  Assumed breathing rate  =  1.2 in /hr.
8.9 x 10 5    72
(small dog)**
2.7 x 10"*
(large dog)**
                                                                               D: 8.9 x 10 5-
                                                Calculations;

                                                Respiratory
                                                 (Post Wash):
                                                                                  2.7 x 10
                                                                                          -4*
              79 ml x 0.236 mg/ml x  1/12,000
              X 0.034316 ft3/! x 1.2 m3/hr  x
                                                               0.1  =  1.3 x 10
                                                                             -4
                               mg/hr.
                                                15,000,000
     A 11 - Dernidl

    AA I'<>:;l.--Wiish respiratory exposure

-------
                              Table  II-Q.  Exposure Data:  Summary of  Exposure  Analysis — Use-by-Use (Cont.)
         Use
     Assumptions Used in Analysis
                  Exposure Analysis
                                                                         Estimation of Unit,  Time & Exposure	  Cohort
                                                                      Dermal    Respiratory   Exposure    Annual      at
                                                                      	Duration	Exposure   Risk
                                                                     mg/hr
                                                          mg/hr
                      hr/year
           mcj/year   persons
     Dog  ShampOG
       Appli cators
t-t
 I
Ul
       Kes i dents
       (I'ost-
        exposure)
a)  Concentrate comes in direct contact with
shampooer' s hands.
b)  Per washing, total volume of 15 ml soap
comes in contact with hands.
c)  Contact time of concentrate with hand is
3 seconds,  then 0.5% solution is diluted
with water  used to wet dog's hair (assumed
to be 1/2 pint) and contact time with
"diluted" soap is 5 min./dog wash.
d)  7 ml "just wet" hands.
e)  There is no respiratory exposure during
shampooing  procedure.
f)  Iiindane transfers to oily layer of dog's
pelt.

a)  15 ml (375 ug)  of a 0.5% lindane
formulation is retained by small dog;
45 ml (1115 ug) by large dog.
b)  Animal  has access to area with volume
ot 12,000 ft3.
c)  Assumed breathing rate = 1.2 m /hr.
d)  7 ml "just wet" hands.
e)  Lindane volatizes for 72 hours after
treatment;  26 treatments per year.
                                                                       23.0        -           2.2      D: 51.4*       ND**
                                                                       Calculations;

                                                                       Dermal:   0.5 g/100 ml x 15 ml x 10  mg/g x
                                                                                1/265 ml x 7 ml x 60 min/5 min = 23.8 mg/hr
          1.0 x 10~5
          (small dog)
          5.3 x 10~5
          (large dog)
1072
R: 0.034-0.1*
                                                                       Calculations:
                                                                                     375 ucj/12,000 ft3 x 0.034316 ft3/!  x
Respiratory            .        ..   	
(small dog):  1.2 m3/hr x 1000 1/m3 x  1/72  x
              1 mg/1000 ug = 1.8 x  10~5 mg/hr
     *  U -  Dermal
     *  i< -  Respiratory
     **ND - Nut  Determined

-------
                               Table  II-O.   Exposure Data:   Sununary of Exposure Analysis — Use-by-lJse  (Coat.)
         Use
   Assumptions Used in Analysis
                   Exposure Analysis
                                                                          Estimation of Unit, Time  &  Exposure	  Cohort
                                                                       Dermal   Respiratory   Exposure     Annual      at
                                                                       	Duration	Exposure   Risk
                                                                       HRj/hr
                                                         mg/hr
                       hr/year
                        iiui/ycar    persons
         Duat
       Appl i caters
M
i
Ul
      Kes idents
        (I'ost-
        treatmeiit
        exposure)
a)  Total lindane  (1% dust) formulation
contacting skin represents 20% of maximum
amount that would cover exposed  skin  area
intentionally dipped in lindane  dust
(1 y fine powder needed to completely
cover 1 pair of hands, or 0.00 m^) .
b)  Maximum dust inhaled over 2  minute
treatment period is 10 nuj/m-5.
c)  All "dust" is respirable size
(10 u or less).
d)  0.294 m^ is the area of exposed
skin from neck, head, hands and  fore-
arms.  Area of hands is 0.00 i«2 _
e)  A treatment takes 2 minutes  and  is
repeated every two weeks for the entire
year, i.e. 26 treatments.
f)  V.inclaiie will volatilize at a steady
rate tor 3 days, at which time all lindane
will, have vaporised.

a)  The assumptions used for docj wash,
resident respiratory exposure, apply
to exposure to dcxj dust.
b)  A typical, pet requires 2 oz  (56 g)
of iv powder per treatment.
c)  There is no dermal exposure.
d)  A resident would be exposed  12 hours
per day, for 3 days per treatment,
26 t iiueu a year.
220.5
0.12
0.87
D:  191*
R:  0.1*
ND* *
Calculations;

Dermal:  1 g/0.08 m2 x 0.294 m2  x  0.01 x 1000 mg/g x
         0.2 x 60 min/2 min =  220.5  mg/hr

Respiratory:  10 mg/m3 x 1.2 m3/hr x 0.01 = 0.12 mcj/hr
           0.0027

Calculations:
            U:  2.53*
                         ND**
                                                                       Respiratory:
              56 g x 0.01 x  103 mg/g  x 1/72 x
              1/12,000 ft3 x 0.034316 ft3/! x
              1.2 m3/hr x 1000 1/m3 x 0.1 =
              0.0027 niy/hr
      *  I) - Dei.mil I
      *  i< -; Respiratory
      **HD -- Nol Di.:term.inet.i

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                              Table  II-B.   Exposure  Data:   Sununary of Exposure Analysis — Use-by-Use  (Cont.)
    Household  Uses

       Shelf  I'aper
t-i
M
I
ui
ui
                            Assumptions Used  in Analysis
                                                                    Exposure Analysis
                                                                         Estimation of Unit, Time & Exposure	  Cohort
                                                                      Dermal   Respiratory   Exposure    Annual.       at
                                                                      	Duration	Exposure   Risk
                                                                      nuj/hr
                                                           nig/hr
             hr/year
           ing/year   persons
a)  Inhalation is primary route of exposure.
b)  After 105 days, 40% of the lindane will
have vaporised.
c)  A 12-foot roll of shelf paper containing
15 mg lindane per ft2 of paper is used to
treat three 4X4X0 meter rooms.
d)  Assume a 1.2 m3/hr breathing rate.
e)  Assume no dermal exposure.
0.002
2520
R:  5*
11,000,000
                                                                       Calculations:
                                                                       Respiratory:
     15 mg/ft2 x 0.4 x 12  ft2  x  l/3a4m3
     1/105 x 1.2 m3/hr = 0.002 mg/hr
       Floor  W<:ix       a)   One  pound  of  wax  treats  800 ft  17  times
                      per  year.
                      b)   Lindane  will  dissipate from waxed  surfaces
                      totally  over a 3  week period.
                      c)   The  air  exchange  is  assumed to be  0.33 per
                      hour due to  outside ai.r  infiltration in a
                      12,000 ft3 house.
                      d)   I'er  treatment, 2770  mg lindane is  applied,
                      which is equal to 4.5 mg/hr  evaporation
                      rate.
                      t;)   Assume no  dermal  exposure.
                      f)   Assume a 1.2  m /hr breathing rate.
                                                           0.01
              0760   R:  08*
                     100,000,000
                                                 Calculations:
                                                 Respiratory:
     4.5 mg/12,000 ftj x 0.66  x
     0.034316 ft3/! x 1.2 m3/hr  x
     1000 1/m3 = 0.01 mg/hr
        K -  Kuspi ral.ory

-------
      Household
n
I-H
I
(It
O\
      I'umi gali on
      Devices
                                Table II-U.   Exposure Data:  Summary of Exposure Analysis — Use-by-Use  (Cont.)
                             Assumptions Used in Analysis
a)  A coarse spray  (0.11 w/w lindane) has
O.Ol'-t particles between 40 and 60 microns,
and 0.1% between 40 and 100 microns, with
95% of spray being deposited on surfaces.
b)  A 12,000 ft3 house will have 12 02
applied over 5 minutes, once a year.
c)  Assume no dermal exposure.
d)  Assume a breathing rate of 1.2 m3/hr.
(based on WAUf Institute Inc., 1970:
Average air concentration is 0.014 ug/1 on
a year round basis (26 applications per year)
                                                                    Exposure Analysis
Estimation of Unit, Time & Exposure Cohort
Dermal
mg/hr

Respiratory
mg/hr
0.0001
Exposure
Duration
hr/year
0 . 08 R :
Annual at
Exposure Risk
mg/year persons
1.0 x 10~5* ND**
                                                                        Calculations:
                                                                        Respiratory:
              12 fl oz x 0.001 x  29.6 ml/fl  02
             x 0.001 x 1000 mcj/ml x  1/12,000 ft3
             x 0.034316 ft3/! x 1.2  m3/hr  x
             1000 1/m3 x 5 min/60 min =  0.0001 mg/hr
         0.017

Calculations:
8760  R:  149*
NU**
                                                                        Respiratory:  0.014 ug/1 x  1.2 m3/hour x 1000 I/in3 x
                                                                                     1 nig/1000 ug = 0.017  mg/hr
      *   I; -  Kciipi iratory
      **MD =-  Hot  Determined

-------
                               Tahiti :iJ-B.  Exposure Data;  Summary of Exposure Analysis —  Use-by-Use  (Cont.)
                            Assumptions Used in Analysis
                                                                                    Exposure Analysis
                                                                         Estimation of Unit,  Time  & Exposure	  Cohort
                                                                      Dermal   Respiratory    Exposure     Annual      at
                                                                      	Duration	Exposure   Ri.sk
                                                                      mcj/hr
                                                                            mg/hr
                      hr/year
                    mg/ycar    persons
     Minor
       Moth Spray -
       Industrial Use
       a)  Applicators
M
I
Ul
                     Baaed  on Gay  et al.  (1975):
                     a)   Aerosol of  0.1%  lindane  produces 50%
                     of  particles  10 microns or  less  and 50%
                     between 10 and  40 microns.
                     b)   Ninety percent of  spray  impinges
                     on  clothing and therefore is not
                     subject to inhalation.
                     c)   Clothes are treated in well-ventilated
                     areas  tor a 2 minute period  at a time.
                     d)   l.iudane concentrations  in vicinity
                     of  spray and  at time of spray are similar
                     to  those ot a 30'i Freon 12  formulation,
                     which  was 44.25 ppm  in the  breathing zone.
                     e)   All other components of  the  Freon 12
                     formulation behave in a similar  manner,
                     but their air concentrations are directly
                     related to the  concentration stated in
                     the Freon 12  formulation.
                     f)   Spray repeated 26 times  per  year.
          0.21         0.87   R:  0.18*      NO**
                                                                       Calculations;

                                                                       Respiratory:   44.25  x  0.1/30 x 0.00119 mg/1 x
                                                                                    1.2 m3/hr x  1000 l/m3 x 0.1 = 0.21 mg/hr
       b)  Occupants
           (l-out-
            Trea tment
            exposure to
            Impregnated
            M.i t e r i a 1 s)
                     a)   Twenty-eight grams of 0.1% spray are
                     used every 2 weeks on a year-round basis.
                     b)   vaporization rate is continuous over
                     2-week period,  at which time all lindane
                     vapor i iced.
                     c)   Effective volume of work space is
                     6000 ft3 infiltration from outside is
                     .33 times per hour.
                     d)   Exposure is J.O hrs per day,  365 days
                     pur year.
        3.8 x 10
                                                                                        -4
         3650   R:   1.4*
Calculations:
Respiratory:
28g x 0.001 x 10  mg/g x 1/336  hr  x
1/6000 ft2 x 0.034316 ft3/! x 1.2  m3/hr
x 1000 1/m3 x .66 = 3.8 x
                                                                                                                1.0 4 mg/hr
*
**
                 rutory
                 Determined

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         Use
Minor Uses (Cont.)

  Insect Spray -
  lln i nhabi ted
  Iln i.ldi ngs
                               Table I.T-0.   Exposure Data:  Summary of. Exposure Analysis — Use-by-Use  (Cont.)
   Assumptions Used in Analysis
        Exposure Analysis
                                                                         Estimation of Unit, Time  &  Exposure
                                                                      Dermal   Respiratory
                                                                     Exposure
                                                                     Duration
                        Annual
                        Exposure
           Cohort
             at
            Risk
                                                                      mg/hr
                                                        mg/hr
            hr/year
 nig/year   persons
                         a)   A concentrate of 20% lindane is diluted
                         1/9 (2.2H.)  and applied as an aerosol.
                         b)   Treatment time is 2 minutes with no
                         secondary exposure 12 times a year.
                         c)   Air concentration assumed to be
                         comparable as in Gay et al.,
                         1975:   44.25 ppm after a 2 minute spraying
                         with a 30% freon formulation.
                         d)   The breathing rate is assumed to be
                         1.2 m:j/hr.
                         e)   1  ppm of lindane in air •- 0.0119 mg/1.
                                                        46.7
                                              Calculations:
                                              Respiratory:
             .40
R = 18.7*
ND**
    2.2/3O x 44.25 ppm x 0.0119 mg/l/ppm x
    1.2 u.3/hr x 1000 1/m3 =46.7 mg/hr
CO
       Empty Storage
       Ui ii fog Spray
a)  All applications made with fogging
    machine.
b)  Droplets all 40u or less.
c)  Applicator exposed to residual airborn.
parti.cl.es, not to main fog cloud.
d)  Applicator does not wear respirator
for overage exposure of 5 min./appl.
e)  l-'ormulation density = 0.0 g/ml. =
6.7 Ibs/gal.
i)  Application 1 per mo., year round.
g)  A 0.5'i w/w lindane solution is used.
h)  A dosage rate of a gallon per 10,000 ft  .
i)  Particle size distribution of "fog" is
in same order of magnitude as an aerially
applied fine pesticide aerosol.
62.6
R = 62.6'
ND**
                                                                       Calculations;
                                                                       Respiratory:
    1 gal/10,000 ft3 x 0.034316  ft3/!  x
    6.7 Ib/gal x 454 g/lb x 0.5g/100g  x
    103 mg/ x 1.2 rn3/hr x 1000 1/m3  =
    62.6 mg/hr
      *  l< -• Respiratory
     ** ND - Not; Determined

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               e.   General Comments Submitted on Work-Place  Exposure

                    Paper Products, Inc.  (30000/10: =M1A)  submitted  an
epidemiological study on 64 employees whose work involved the use of
lindane.  Employees were divided into three groups according  to  years  of
exposure, and into another three groups according to blood levels of total
BHC, including lindane.  Sleven biochemical and eight hematological
examinations were carried out.  The study reported no differences between
these groups of employees.  The registrant argued that  the study indicated
no adverse effects from lindane on liver  functions and  hematopoietic
systems of these workers.

                    The Agency does not disagree with the conclusions  that
no effects were noted.  However, the limited population observed and extent
of parameters measured dictate that the probability of  noting an adverse
effect would be negligible.  Therefore, this study is decidedly  not ade-
quate to demonstrate that workers exposed to lindane experience  no  adverse
effects to the liver or the hematopoietic system.

          3.   Dietary Sxposure;  Agency  Determinations

               For purposes of determining exposure to  lindane from
residues on food, the Agency has used data showing lindane residues
calculated for 12 composite food categories from the FDA market  basket
(total diet) survey during the period 1971 to  1976  (SPA 1973e) .  Table II-6
shows the average lindane residue in each composite category, and the  daily
intake of lindane from this average in mg/1.94 kg diet.  The  total  of the
average daily exposure for all 12 food categories was then converted to
mg/kg body weight per day for an average  adult consuming 1.94 kg focd/day.

               The calculations shown in  Table II-6 derive from  actual
residues and according to the Agency's best determination represent a
reasonable estimate of dietary exposure.  It should be  pointed out, how-
ever, that average daily dietary exposure is likely to  be somewhat  higher
for children than for adults.  This would be due to  1)  the relatively high
residues of lindane in dairy products as  compared to other food  categories
(Table II-6), and 2) the relatively high  proportion of  dairy  products  in
the diets of young children.

          4.   Applicator and Homeowner/Householder/Occupant  Sxposure;
               Agency Determinations

               The Agency has prepared estimates of dermal and respiratory
exposure  for those uses of  lindane which  are under  review.  Following the
Agency's policy  of making cautious and prudent assumptions in the  face of

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the uncertainties which, given current methodologies, 'underlie  exposure and
risk calculations, these estimates are based on worst-case  assumptions
about actual use practices.  Wherever possible, actual  exposures  are in-
cluded in the calculations.  Table II-7 shows representative  formulations
together with uicd.es and recommended rates of applications.  Agency calcu-
lations are based on representative formulations-  Table  11-3 is  a summary
of the Agency's exposure analysis of lindane, use by  use; assumptions and
calculations (60-kg adult weight assumption) are included.  Assumptions are
Agency-generated unless specifically designated otherwise.  The following
Subsections (a) through (n) briefly outline information pertinent to the
assumptions proceeded upon for each use.

               a.   Applicator Exposure:  Hardwood Logs and Lumber

                    The U.S. Department of Agriculture  (30000/10:£49)
submitted a description of three commonly used methods  of BHC application
in sawmills.  Since lindane has replaced BHC in sawmills, the three methods
now apply to lindane use:  1) Green chain dip vat, wherein   freshly sawed
boards are completely immersed prior to stacking; 2)  green  chain  spray,
wherein the lumber is conveyed through a spray booth  equipped with a low-
pressure spray system; and 3) lumber package dip vat, wherein stacked
lumber is immersed into a dip vat, then allowed to drain.   These  procedures
take place in a covered but open plant, with workers  assisting in guiding,
pulling, and stacking the lumber.  The USDA states that workers who handle
treated lumber are provided with rubber gloves, aprons  or.rain suits, and
boots.  If these  items were used exactly as prescribed, little dermal
exposure would result (EPA 1978d).  However, subsequent inspection of some
sites by SPA  revealed that not all workers wore this protective  gear,  and
not all gloves were impermeable to lindane.  The Agency has calculated
exposure for head, neck, and hands.  It is assumed that the general surface
areas surrounding the vats are saturated with  lindane,  and  inhalation
exposure results  from vaporization peaking at  a  10-percent  lindane air
concentration.  Yearly exposure is assumed to  be 3 hours  per  day, 250 days
per year.

               b.   Applicator Exposure:   Seed Treatment

                    This analysis is based on  a  typical formulation con-
taining 25 percent lindane.  The Agency has assumed  that  dermal and inhala-
tion  exposures  from barrel treatment and seed  drill-box rigs  will be about
equal.  Exposure  in these  situations would be  from air-borne  dust generated
during pouring  of lindane  powder and stirring  of  seed-powder mixtures,
whether by hand or mechanically.  The  Agency has  assumed  also that seed
treaters do  not wear  respirators or protective clothing,and that r.o more
than  1.7 hours  oer dav  is  soent at  this oceration.
                                   11-60

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               c.   Applicator Exposure:  Avocados

                    A lindane concentrate is diluted  to  a  0.04 percent
weight-to-warer (w/w) solution and applied as a  spray to control infesta-
tion of avocado trees in Florida.  Two applications are  made  at a 6-week
interval.  The Agency assumes that a single applicator treats one grove in
a day, twice per year.  Both dermal and respiratory exposures are antici-
pated.

               d.   Applicator and Homeowner Exposure;   Ornamentals

                    Lindane sprays are used by homeowners  and commercial
nursery workers, usually as a dilution (0.5 percent w/w  lindane in solvent)
of a 20-percent lindane formulation.  Hand-held  hydraulic  or  compressed-air
sprayersare used.  Use patterns vary greatly and the  range of possible expo-
sures varies with duration of spraying time and  with  the number of applica-
tions per season.  It is assumed that the applicator  wears no protective
clothing, gloves, or respirator (worst-case scenario).

                    Concerning homeowners, it was assumed  that a homeowner
expends one hour applying one pound of the formulation per year.

                    For commercial application it is  assumed  that 3600
acres are treated by a manpower force ranging from  30 to 1200 persons per
year.  Exposure time ranges from 3 to 120 hours  per year per  person.   The
extremes of this range are thought to be unlikely,  but an  average exposure
time is not known.

               e.   Applicator Exposure;  Cucurbits

                    For this analysis, the Agency has selected a typical
formulation which contains 25 percent lindane diluted to a 0.06 w/w
(lindane to water) spray, applied by a row crop  boom  sprayer.  Three  to
four applications are cade per season, and an applicator is thought to be
exposed for 0.7 hours per application.

               f.   Applicator Exposure:  Christmas Trees

                    Back-pack sprayers or handgun pressure sprayers are
used  to apply  lindane solutions  (0.05 percent to 0.5  percent  w/w lindane in
water) to Christmas trees and freshly cut stumps during  winter, early
spring, or summer for several pest control measures.   Several application
methods are used, with foliar treatments  resulting  in higher  exposure than
stump or trunk treatments.  No exact numbers cf  applicators or applications
for each use can be calculated because the pests and  usage situations vary
greatly.  There are approximately  10,000 private Christmas tree growers
throughout the United States, and  the exposures  per grower will be con-
sidered averages of  total lindane  usage.   Since  use practices and ambient
temperature during treatment will  vary greatly,  the Agency has calculated
an  exposure range derived from a combination of  the three  main modes  of
                                   11-61

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use.  The exposure and risk are expressed as a range between  the  extremes
predicted for these uses.  This should include most patterns  of use and
variations.

               g.   Applicator Exposure:  Pecan Orchards

                    Lindane is used in a single-spray  application to
foliage with a groiind airblast sprayer.  A  typical  formulation of 12.5
percent lindane is diluted to a 0.05 percent w/w  lindane  in water spray.   A
single pest-control worker can treat one average  farm  in  one  day  (approxi-
mately 8 hours), once per year.  There are  approximately  1200 pecan farmers
in the United States, and we assume all use this  procedure  and each does
his own spray operation.  It is assumed that no protective  clothing,
gloves, or respirator are used.

               h.   Applicator Exposure;  Forestry

                    Lindane is used in emergency  conditions to spot-treat
insect infestation sites.  Large areas are  not ordinarily covered by any
single application, and  the total use of lindane  for controlling  forest
insect pests is about 4,000 pounds a.i. per year.  A 0.5  percent  (w/w of
emulsified lindane in water) solution, diluted frcm a  20  percent  formula-
tion, is applied to the  back of infested trees as a low-volume spray (back
pack) to the point of run-off.  The exposure analysis  and risk calculations
assume that no protective clothing, gloves,or respirator  are  used.   However
the Agency is aware that the U.S. Forest Service  enforces its requirements
for protective garb and  safe-handling procedures.  Use practices  by applica-
tors not employed by the Forest Service are less  predictable.  It is esti-
mated that one operator  could work at this  operation  for  30 days  per year.

               i.   Applicator Exposure:  Livestock

                    As  an emulsion, lindane is applied as a pressurized
spray or dip .to  farm animals.  Treatment periods  vary  with labels,  but
treatments can be repeated as frequently as every two  weeks.   Considering
geography  and climate,  range of pest  to be  controlled, etc.,  it is reason-
able to conclude that no more than nine  such applications would be done per
annum.  The emulsions are 2 percent and 25  percent  concentrates diluted
in  water for the dip or  spray.  For purposes of  this  analysis, the Agency
has  selected a formulation which  yields a  final  spray  solution of 0.045
percent w/wlindane  in water  (EPA  1978e].   It  is  assumed that  the  operator
wears no protective clothing, gloves, or respirator.   Exposure estimates
herein were calculated  for spray  application  to  swine, where  exposure rates
are highest.  Exposure  to dip vat operators is considered to  be less than
this due  co the  different operation procedure.   In  aany cases, a  lindane-
toxaphene  mixture  is used for  these applications, in  which case the lindane
excosure  would be  one half  to one  third  that  calculated here.
                                  11-62

-------
                    The assumptions in this use profile represent a. worst-
case estimate for body surface exposed, concentrations used, and exposures
per annum.  An applicator is assumed to be exposed for about 2 hours per
year in the actual spraying procedure.

               j.    Applicator and Occupant Exposure:  Structures

                    A lindane emulsifiable concentrate (0.5 percent w/w
lindane in water)  diluted from a 20-percent lindane formulation is applied
with a paint brush along small areas or applied with a coarse spray for
large areas.  An estimated 10,000 houses are treated per year.

                    For the applicator, both dermal and inhalation exposure
are assumed to be relevant during the 1-hour application time.  It is
assumed that an average pest control operator treats between 10 and 20
homes per year.For home occupants, only inhalation exposure is anticipated.

                    Terminix International (30000/10 : s26) argued that
exposure to humans and non-target organisms is almost non-existent since
lindane is retained in the wood under-structure where it is applied.  The
registrant also stated, "Because lindane is water based this also reduces
its vaporization and dispersal into non-target areas,"  The Agency believes
that lindane is more volatile than the registrant suggests.  Lindane's
vapor pressure at 30  C is 1«3.x 10   mmHg, compared to DDT at 7.3 x
10"  and dieldrin at 9.9 x 10   (EPA 1978d).  Data supplied by the CDC
report are considered more definitive than the assumptions suggested by
this registrant.

               k.   Applicator Exposure:  Pineapples

                    Registration for use of lindane on pineapples is
presently restricted to the state of Hawaii (ZPA  1978e).  In this use,
lindane is injected into the soil with a fumigant before planting.  Based
on an exposure analysis for a similar use of DBCP, the Agency assumes that
the primary route of exposure is by inhalation, and that at the low concen-
trations of pesticide applied, vapor concentration levels in air above soil
will be a direct function of the vapor pressure,  regardless of the relative
mole fraction of the pesticide applied to the soil.  After the lindane is
injected, the field is covered with a plastic mulch.  Potential for
exposure depends on duties performed (equipment operator, mulch operator,
or supervisor) during an assumed  14-hour working  day.  However, the
anticipated hourly exposure associated with any of these functions is very
saall  (approximately 5 X 10   mg/hr).

               1.   Applicator and Householder Sxposura:  Pets

                    (1)  Pet Anti-Flea Collars

                         For this analysis, the Agency has selected a
typical formulation containing 0.61 percent lindane  and assumed a dilution
factor of 10  (£PA  197Se).  The Agency has extrapolated from Shell Chemical
                                  11-53

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Company (1976) data on 5 percent DDVP incorporated  into  cat  collars.
According to label directions, collars are effective  for 6-3 weeks.   A
constant release rate during this period  is  assumed in connection with
inhalation exposure.  Because the lindane is  incorporated into  the collar
rather than on the surface, dermal exposure  via  handling the collar is
considered negligible.

                    (2)  Dog Wash (Veterinary Use)

                         For this analysis,  the  Agency has  selected a
typical formulation containing 10 percent lindane  (final use concentration
is 0.085 gm lindane/ml)  (EPA 1973e).  The Agency assumes that a veterinary
technician would treat 10 dogs per day, exposing both hands  (unprotected)
for 5 minutes during each dipping application.   Inhalation  exposure during
this treatment period was not considered  to  be  significant.

                         The Agency also  considered post-treatment inhala-
tion exposure to dog owners from lindane  volatilized from the treated ani-
mals.  The Agency assumed that the estimated residue  would  volatilize
completely within three  days, during which time  the dog  would be in common
residence with the owner (SPA, 1978e).  It is conceivable that  some lindane
may contact human skin if the animal is handled.  This would be a highly
variable and extremely small exposure.  Absorption  rates from brief contact
would also be extremely  small.  However,  even minimal exposure  to and
absorption by children must be viewed with extreme  caution.   The Agency has
no data by which to gauge acceptable margins of  safety  for  children.

                    (3)  Dog Shampoo

                         For this analysis,  the  Agency has  selected a typic-
al formulation containing 0.5 percent w/w lindane  in  an  oil  soap base (EPA
1978e).  The Agency assumes that the concentrated  product will  directly
contact the shampcoer's  hands for 3 seconds,  that a total of 15 ml soap
will contact the hands during each washing,  that the  0.5 percent concen-
trate will be diluted with one-half pint  water,  and that hands  are in this
diluted soap for 5 minutes during each washing.  This procedure is repeated
25 times per year.

                         The Agency also  examined  post-treatment inhalation
exposure to dog owners from lindane volatilized  from dogs washed with the
above formulation.

                    (4)  Oog Dust

                         Animals are dusted  with a  one-percent  lindane dust
by hand application.  The Agency assumes  that 26 applications are made per
year  and residents  are  exposed to the  animal 50  percent  of the  day post-
application.  Dermal  exposure estimates were made  for the treatment pericds
and  inhalation exposure  estimates were mace  for  the immediate post-
application period  when  lindane would  volatilize from the animal's pelt
(EPA  I973e) .
                                   11-04

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               m.   Applicator Exposure;  Household Uses

                    (1)   Shelf Paper

                         Lindane-impregnated  shelf paper  is  registered for
use in non-food areas such as chests, drawers, closets, and  storage areas.
It is estimated that four and one-half million rolls  of shelf paper are
sold per year.  The Agency assumes two rolls  per year are  used per house-
hold, and therefore that two and one-quarter  million  households per annum
contain the product.

                         The human contact time, during which the paper is
spread onto the desired area is very brief, and the Agency does not con-
sider this dermal exposure significant.  The  primary  route of exposure is
inhalation of the vaporized lindane.  The Agency assumes  that 40 percent of
the lindane will be released over a  105-day period at a constant rate.

                         Three registrants, Millen Industries (30000/
10:#7A), Paper Products (30000/10:341),  and Athena Corporation (30000/
10:?f18A), submitted a total of five  comments  on exposure  from lindane-
treated shel paper  (ZPA 1978d).  The comments dealt  in general with expo-
sure through food stored on treated  shelf paper, and  with  lindane air con-
centrations from shelf paper in enclosed areas.  None of  these comments
were pertinent to the Agency exposure analysis, which determined that the
primary route of exposure from this  product would be  from_inhalation of
vapors in open areas  (SPA 1978e.)

                    (2)  Floor Wax

                         A solvent-based floor wax,  laced with lindane (0.5
percent w/w) is used on various floor coverings at normal  maintenance inter-
vals (2-3 weeks).   Application methods vary considerably.

                         Dermal exposure from application  is anticipated
but could not be estimated due to variation in  application methods.  Dermal
exposure after application is also possible,  especially for  children.  How-
ever, this highly variable situation also disallows  a reasonable estimate
of exposure.

                         The Agency  assumes that  the  significant exposure
mode will be due to respiration of the  lindane vapors for three weeks after
wax  is  applied to the floor.

                    (3)  General Purpose Household'Spray

                         A 0.1-percent  lindane  spray, formulated in
petroleum distillate  is  registered  for  use  in homes  in surfaces of beds,
carpets, draperies, etc.  The spray  produces  particles about 40 microns
size and 95 percent of  the sorav volume  deoosits  on  surfaces (2?A  1973e) •
                                    11-65

-------
                         Contact with the sprayed surface could  possibly
result in some dermal exposure, but because of the varied nature  and
extremely varied surface areas (and types of surfaces)  involved,  calcula-
tion of dermal exposure is not possible.  However, for  most  situations,
dermal contact is likely to be insignificant (e.g. curtains, carpets,
etc.).  In some cases, the dermal contact may be relevant (crib  mattresses,
rugs in homes of small children), but defensible estimates cannot be.made.
The Agency assumes that 12 ounces of spray  will be applied  in a  home
(volume of 12,000ft ) and the airborne particles will be evenly  distri-
buted throughout the home, and will have an effective longevity  of 5
minutes.

                    (4)  Smoke-fumigation Devices

                         These devices, variously termed fumigators,  smoke
generators, "bug-tabs," "moth-clouds," etc. produce over a very  short  time
period either a smoke, fume, or fog of lindane with or  without associated
non-volatile particulates such as carbon.  The purpose  of the device  is  to
produce a super-saturated suspension and/or vapor of lindane in  an enclosed
space.

                         Typical formulations for this  use contain 2.3
percent to 20 percent lindane, and maximum vapor concentration varies  from
0.4 to 1.9 mg/ft (average of 0.3 mg/ft )  [EPA 1978e].   The Agency
assumes that treatments will be biweekly all year.

                         Grain -storage bins, greenhouse, household areas,
etc. are treated.  Label directions instruct to clear the area of house-
hold pets and persons.  Since it is assumed that persons are not in the
area during fumigation, dermal exposure should not occur.  Estimates  of
exposure due to contact of material"' after application  cannot be  made,
although such exposure may occur.

                         The Agency assumes that the major exposure mode
would be via respiration of residual vapor in the household  er.vironment
during the 2-week post-application period.  It is important  to note that
lindane is absorbed onto the surface of many materials  during vaporizer
use.  Exposure is therefore continuous as lindane is revolatized from these
surfaces.  A study by the U.S. Public Health Service demonstrated that  20%
of  the lindane residues initially deposited on painted  walls during
vaporizer use were present in these surfaces after  179  days  (E?A, 197Se).

                         Continental Chemiste Corporation  (30000/10:419)
submitted data by WAJIF (1970) to determine the amount of lir.dar.e  deposited
on  food left exposed during smoke-fumigation.  (Leaving food and eating
utensils exposed during use is against label directions.)  The Agency
points out that  the  principal route of exposure to  lindane  from  this
product is through inhalation.  Nevertheless, using the registrant's
figures, the Agency has determined that a 60-kg person  who  eats  from  a
10-inch dinner plate the day after treatment with the registrant's product
could be exposed to 0.1153 me lindane, or 15 percent cf the  acceptable
daily intake (Memo 1978c)
                                  TT-66

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60. 4U
6.6 x 10~6
4.3U
O.OJI2
6.40 x 10.
1.911 K 10
nl h *lc i i»n\  tiii'l  i'mi|il i a I ory

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                                              Table 11-9.  Estimated Applicator  Txpoiiuru, Proliant Use Practices (Cont.)
Ol
Durinal Haupl ratqry
(m.j/lir) (aig/hr) •
UbU
l)oy bhuiupin)
Appl IcaLoru 23.8
I'oiit-Appllcatloii - 1.8 x 10 -
5.3 x 10
l)0(J Duut
Appllcatoru 220.5 0.12
l-oiiU-Appl loatlon - 0.0027
UOtlUiillOld tlllOll
iilmll: 1M>|.ur - 0.002
floor Wax - 0.01
llotiucliol'i ijpray - 0-0001
I'n:. ilij.it Ion Uovlcea - 0.017
Minor tluu^
H.Lli ripcay,
Inaiuitrlal Uuu
b|>i-ay - 0.21
lm|,L'.!.jiiaLed Materlala - 3.6 X 10~
llr/day

0.083
24
0.03
12
24
24
0.08
24

0.03
10
nig/day*
Durmal Respiratory
1.90
4.32 x Ifl" -
1.27 x 10"
6.6 3.6 x 10~3
3.24 x 10"
4.8 x 10"
0.24
7.8 X 10~6
0.408

0.066
3.6 x 10
day/yr

26
78
27
78
105
365
1
365

26
365
mq/yr*
Durutal Ruuplratory
51.40
3.37 x 10 j -
9.92 x 10~
170.2 9.72 x 10~S
2.53
5.04
87.6
5.0 x 10~6
148.92

1.716
1.314
                      liul 1 Jli
                                                 46.7
                                                                    0.03
                                                                                                  1.38
                                                                                                         \
                                                                                                                        12
                                                                                                                                              16.56
                                                 62.6
                                                                    0.08
                                                                                                  4.98
                                                                                                                        12
                                                                                                                                              59.76
       * Loth tluruial and  respiratory
\

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                                            Tal>le II-IU.  Total  Uoily flouuu  (Apfil Icdtora) ,  Preutmt Hue  1'iactlccu

Ilin! ll.jlm.il II|.lnk

limuial piij/klratory nnj/kq/tlay*
0.012
0.130
0.01
0.003
O.dO'J-0.24
6 x I0~5
0.027-0.04
0.01
0.01
1 x I0~i|
1 x 10"
0.03
0.012
Total
mty/k<|/tiay
0.225
0. 181
0.68
0.053
0. 159-0.424
0.00226
0.067-1.24
0.6U
0.14
0.01
0.012
0.96
0.012
Annual Total
m,i/|( u/yr
56. 3
0. IUI
1.35
0.053
0. IS9-0.424
0.000
O.OU-1.5
0.60
4.2
0.01
0.012
9.6-19.2
1.000
 >ij Wauli
  A|>|>! I..-ill in o     lilt
  I'l>ul-A|i|il Ic.l-
  tlon
2 K  10
       -5
                                                                                     I.I  x 10
                                                                                              -7
                                                                                     I.U  M 10
                                                                                              -6
                                    3.6 x  10
                                     I. x  10
-5
-4
                                                                                                                                l.t x  10
                                                                                                                                         -7
                                                                                                                                I.H X  10
                                                                                                                                         -6
3.6 x  10
1.1 x  10

                                                                                                                                                                         1.1 X  10
                                                                                                                                                                        6.6 x  10
                                                                                                                                                                                  -7
  5  x 10
2.8  x 10
                                                                                                                                                                        0.4 x  10
                                                  -4
                                                  -3
                                                                                                                                                                                  -3
Illllt  i'<:ii|»I i at.oi y  uptake  nautiinuil

-------
                                                     TnMo  11-10.   Total Ibxly lioaun  (A|>1>1 Icatoru) , finunut  Duo  Practlcun  (Cunt.)
                       llunujl ll^l nkel
  A,.,.I li.al u        10\
  I'oul -A|t|kl l«:at Ion   -
                                                                       		  llaHjii ral.ofy in<|/k<|/l ll u\n ay,
1 "       I II.1.1.ill l.ll lino
           M.I 1 tt r 1 a 1 u
                                                                                              6.0 X  10
                                                                                              1.1  X  10

                                                                                              6  x  10~5
                                                                                                        -4
                                                                                                                                         6.0 x  10
                                                                                                                                                   -1
                                                                                                                                   1.1  x 10

                                                                                                                                   6 x  10~5
                                                                                                                                                   -4
                                                                                                                                                                                  2.5
                                                                                                                                                                                  2.7 x  10
                                                                                                                                                                                            -1
                                                                                                                                                                                  2.) x  10
                                                                                              — 2
            ll.ll l.llll.JH
                                                                                              0.0 J7
                                                                                                                                          0.017
                                                                                                                                                                                  0.4
   Ki»|il y  SI »M tt»)d
   III it to'i  :ii»i .1 y
                                                                                              O.I2U
                                                                                                                                         0 . 1 211
                                                                                                                                                                                   1.5
       'Illllt  lu,,i|il i ..< .u y ii|.t ,>ko duuil

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absorption of lindane from liquid formulations  is  tsn  percent,  and one
percent frcm dry formulations  (Gross,  1978).  Total body  dose  calculations
for each use of lindane under  review are summarized in Table 11-10.   In
lieu of any information on oral, or inhalation absorption,  the  Agency will
assume 100 percent uptake of ingested  or inhaled  lindane  (Gross,  1973).

     C.   Risk Assessment

          Based on the exposure levels calculated  for  each use  of lindane
under review (Subsection II.3), the Agency has  evaluated  the degree  of risk
for carcinogenicity, fetotoxic effects, and acute  and  subacute  central
nervous system effects (SPA 1978g).

          Because the Agency did not perform a  quantitative exposure analy-
sis for all the numerous minor uses of lindane, no quantitative risk assess-
ment could be performed for minor uses other than  those which  are specific-
ally under review.  The Agency believes, however,  thatsince there will be
some level of exposure, however small, from these  various  'uses, there will
also be some corresponding risk to the users of these  products.  In  addi-
tion, the Agency points out that, even though exposure to,  and  risk  from,
these minor uses may be small, their importance is in  their contribution to
the total body burden of lindane in the general population.

          The succeeding subsections address the Agency's  risk  assessment
of lindane in terms of 1) carcinogenicity, 2) fetotoxic 'effects,  and 3)
acute and subacute central nervous system effects.

          1.   Risk;  Carcinocenicity

               The Agency has  extrapolated estimates of the carcinogenic
risk from lindane exposure using the one-hit or exponential model with no
assumed threshold.—   This model is used by the Agency in various
forms for nearly all of its carcinogenic risk assessments.   Admittedly,
these risk extrapolations involve many uncertainties.   Among those
extrapolations which most subject the  estimates to error  are the  high-dose'
animal to low-dose human conversions.  Others are  dose rate effect and the
actual human exposure.

               The following statement, published  by the  Interagency
Regulatory Liaison Group (IRLG), is representative of  the  Agency's stance
in the face of the uncertainties involved in quantitative cancer  risk  •
assessments:

     Despite the uncertainties, risk estimates  can be  and are  being
     made, not only by some regulatory agencies but by other scien-
     tific bodies.  Because of the uncertainties,  however,  and  because
157
—   Another estimate of r^sk was also developed, but  tr.is  one  used
     the log-probit ^odel.  The estimates  frcm this nodal are being
     reviewed by the Agency's GAG and will be discussed  in  ?0 4.

-------
     of the serious public health consequences if the  estimated risk
     were understated, it has become common practice to  make  cautious
     and prudent assumptions wherever they are needed  to conduct a
     risk assessment.  This approach has a precedent in  other areas
     because of gaps in knowledge.  Thus current methodologies,  which
     permit only crude estimates of human risk, are designed  to avoid
     understatement of the risk.  It must be recognized,  however,  that
     in some circumstances this cannot be guaranteed because  of other
     factors that may enhance human response, such as  synergistic
     effects.  Thus risk assessments should be used with caution in
     the regulatory process.

     With the present state of knowledge, the quantitative  assessment
     of cancer risks provides only a rough estimate of the  magnitude
     of the cancer risks; this estimate may be useful  in setting
     priorities for control of carcinogens and in obtaining a very
     rough idea of the magnitude of the public health  problem posed  by
     a given carcinogen.—

               Multi-test evidence indicates that lincane causes oncogenic
effects in mice.  (Refer to Subsection II. A.I.)  For purposes  of  extrapo-
lating use-by-use estimates of the cancer risk posed by  lindane to humans,
the Agency has chosen to use the results of Thorpe and Walker (1973).   This
study was selected because the number of animals with  tumors  in both males
and females was significantly above the respective controls,  because the
number of animals with tumors were comparable in each  sex',  and because the
experiment had an extremely low ? (pool) value (<10  ).  The  Agency  has
little doubt that lindane is carcinogenic to mice at the doses  used  in this
experiment (SPA, 1979).

               Estimated cancer risks for each use of  lindane under  review
are.given in Table 11-11.  Dietary cancer risks are estimated at 1.7 :c
10   or roughly 17 tumors per million people.  The dietary  risk is
additive to other risks (e.g., applicator, residential)  posed from exposure
to lindane from other sources.

          2.   Risk;  Fetotoxic Effects

               The Agency's risk assessment of the reproductive and  feto-
toxic effects of lindane has necessarily focused on fetotoxic effects.  The
Agency was unable to perform a quantitative risk assessment of the general
reproductive effects of the pesticide based on available data.   Fetotoxic
risk to humans has been evaluated by comparing the no  observable effect
level (NOEL) in animal studies with the highest estimated daily acute  expo-
sure for each use.  The resulting ratios are referred  to as margins  of
safety (MOS) and represent crude measures of risk to exposed  populations.
—   Quoted from IXLG, "Scientific 3ases for Identification  of
     Potential Carcinogens and Estimation of Risks," 44 ?3 39853,  39S71-72
     (5 July 1979 ).

-------
l.li;  11-11.   yumm.ny
                                                                            of  Applicator  Itli.k,  1'ruseiit  Hue  I'
                                                                                                    Cancer  Probability
Kel'ol.ox Ic 1 ty (teneral Acute Toxlclty
II:..: Mar.jin of U.ifety Itil.jin of Safety
ll.ii dwood Lumber 22 11
;;.:<:. 1 Tl ,:..! U..:I.C 211 14
Avocado (iioveu / 4
1 . l|,.i,,..',»m.:i Use '34 47
I?. r,.i,m,<;i<:i dl Hie 31-12 16-6
C.iciu 1,11 u 2,500 1,250
clirisiiu.iu Treeti 75-4 37-2
l'.-«:.ui:i 7 4
M l-'..i .::.! . y 3C. 1U
1 I.I v.::.l •„ K (Spi.iy bip)
-' II.:. :t 500 250
4~* r.iik 4 If. 208
SI 1 in: tin e:~>
1 . li.l.ubll .,nl :, 4lb 3
.'.. Applicator:! 5 3
i-ine.ippl.suV 4.5 x I07 2.3xl07
I't-l :.
1. !'.:! .llHi-l|.:.i collars JxlO° 1.4x10^
'.'. . h,..| U.,:.li
.1) Appl ic.il ..i :; 2.5xlo'' 1.3xll'|5-
L) |M:.t-Ap|>l Icut lull 1 . .Ixlll^-'l. 5x 1O 0. 7x1 0^-2. 2x1 04
I'.at lluate
Lifetime Kluk'
2.CxlO"2
U.3xlO~S
6.2x10-4
2.4xlO"5
7.3x10-5 to 2.9xlO~J
4.1xlO'6
3.7xlo"5_5 .QxlO"4
3.1xlO-4
5.0xlO-&
4.GxlO"4
4.4xlO"3 to U.llxltt"
io-)2
2xl()~4
2.4xlO"7
7.0x10"°
1'eruonu
240O
130.OOO
275
75,000
30-1200
'J50
10,000 Creat variation
1200
1000 Anticipated to U;
male workers
250,000
10,000-12,000
40,000 luMiseu: all a.je
500-1000 yroiipu ex|.oaed
1601)
III)**
130,000
15,OUO,UOO
(:lvt:ii i lie exi i <:n>e I Y  lil.jli iuui<|in^  i*f  ui.it'ety  tor  thi: thre^liolil  efftji:!.^ of  fototox iol ty and acute toxicity,
i ho  A,|i:nuy .;,:.ii;i t.l.ii-:, llie pi eiiumpt Ion cm plneuppleu i..l>iLl(,|  for  the:le  two effects.

-------
                                                      Tnhlo 11-11.   Siui|ii|4(y  A.uuuuuinui>i  of A|'(>1 Iculor  Illak, I'cuuunt Uuo  I'ultuiiio  (Cent.)

                                                                                                                      Concur  l'tol>ul>i Illy
                                                   Kuloloxlclly           Cultural Acule Toxic Illy          estimate
                                                 Margin i>f_Saf£l-y          ^iii'ji"_i;£ .Salijty	      l.ttutliuu Hlak*
                                                                                                                                            KalIwdloJ I
                                                                                                                                              I'craoim
                                                                                                                                                                               liuiiiaika
       I.)   ro:>t-A|>|>l loollon

  4.   IK,i) final
       u)   Ain'l l*:atoi:
       lit   |-oal.-A|.|>l Icutlou

llotiuultol*! IJunu
  I .   SI.elf  I'.ll.uC
                                                    I6,b66
                                                      J.040
                                                                Ui.OOO
                                                                 'J,260
                                                                 6,l)OO
                                                                                           U.lll
                                                                                41.666
                                                                                 4.6)0
                                                                                  l.OUO
                                                                                                              3.6x10
                                                                                                              2xUr6
                                                                                                                        1.5x10
                                                                                                                        J.'JxlO
lll>"
Mil"
III)4'
Illi'4
                                                                                                                                                          11,000.000    Ml  a.ju  ycouou
            l.   flooi  11. .M
                                                                                               625
                                                                                                                        6.1x10
                                                                                                                                                         IOO.OOO.OOO    All  &UUO
     lloil^oliolil lj|iidy
                                                                ).li«10
                                                                       7
                                                                                                                        C.OulO
                                                                                                                               -4
                                                                                                                                                             ll|>*
                                                                                                                                                                          All  tliJU (JCUI103
Ul
 •t.   tiiuoku  fliiul'JBtloi

     ItoV I CUU
                                                                    ~HM
                                                                                                I'Jd
                                                                                                                        l.lxlO
                                                                                                                                                             Illi* *         Ant lol |>4l feit
laof llnou
 I.   li..ltiul i I a I  llau  llol li  ti|iioy
    -  A|i|>l Icnllou
                                                                4.5x1(1
                                                                                                                               -6
            Z.   Oiilnlu.l.ll c.l llul lillixjo
             I .   l-jnol y UloroiJO
                 III il  l'*ol:  UKjiOcmio  Iky tltla IHO<|U.
              Cui..:<)i  Auouusiiiunt Hi oti|>  (CM.)  uul Inulu aiituiuluil 16  AiKjiiuL 1'JCJ.
          Ilitlui   fioiuo CM|M>UIII'U auo«uti|it I oitd  may «1lttoi'  oll'jlitly  tuxu  Llioqe ti
          (lt(»:it  en l<:ti I til. loua .
                                                                                     til

                                                                                     20
                                                                                                                        1.9xlo"
                                                                                                                        5.5MIO
                                                                                                                               "4
                                                                                  In tlio maojlil  of oofcty
                                                                                                                                                             '«»*
                                                                                                                                                               I'CO only
          '"   iii>   iini not

-------
               It should be emphasized that, as with  the  cancer risk assess-
ment of lindane, considerable uncertainty surrounds the assessment of fate-
toxic risk.  The anticipated adverse effects of a pesticide  vary with the
extent of exposure associated with its various uses,  and  the Agency has
necessarily made cautious and prudent assumptions concerning exposure.
(Refer to Subsection II.3., "Exposure Analysis.")  Because current methodo-
logies permit only rough estimates of human risk and  because of the serious
public health consequences if the estimated risk were understated,  it is
likewise Agency practice to use the most conservative results from the
animal data in making risk estimates for the human population.

               Although fetotoxic effects are considered  a chronic human
risk, it should be pointed out that fetotoxicity can  result  from a single
exposure.  Hence the Agency is concerned about possible cases of both acute
or subchronic exposure to pregnant women.—   The Agency's focus of
concern is on the potential injury to the fetus resulting from the mother1s
exposure to lindane, whether such injury occurs in either the presence  or
in the absence of toxic signs in the mother. The data on  lindane indicate
that the pesticide has the potential to cause fetotoxic effects both in the
absence and in the presence of maternal toxicity at dose  levels close to
human exposure levels.  (Refer to Subsection II.A.2.)

               Although Earl et al. (1973), which showed  that lindane feed-
ing at both 7.5 and 15.0 significantly increased the  proportion of still-
births to beagle dogs, stands unrebutted as evidence  of the  fatotoxic
effects of the pesticide, the study did not determine a NOEL and therefore
cannot be used as a basis on which to calculate margins of safety for feto-
toxic effects.  On the basis of the following studies, however,  the Agency
has been able to determine a NOEL of 5 mg/kg/day.  Oral studies rather  than
available studies using the subcutaneous route were selected for risk
assessment purposes because the oral route (g.avage) is that  route which has
been historically and consistently used for risk evaluation,  and the route
specifically identified as.the route of choice in the SPA Proposed Test
Guidelines (Subpart ?) .  Dermal toxicology, when done, often appears to
exert excessive stress on a pregnant animal and poorly indicates the actual
dose absorbed.

               a.   Palmer and Loveil [1971 (confidential;unpublished)],  an
oral fetotoxicity study involving femals specific pathogen free rats:  NOEL
5 mg/kg/day.

               b.   Palmer and Neuff [1971 (confidential; unpublished)],  an
oral fetotoxicity study involving Mew Zealand white rabbits:   NOEL at least
5 mg/kg/day.
 13'
 —'  In  connection with  the  various  uses  of  lindane  on  pets,  the
     Agency is also concerned about  potential  fetctoxic effects in cases of
     exposure to pregnant  animals.

-------
               c.   Bauer and Frohberg  [1972  (confidential;  unpublished)],
an oral fetotoxicity study on MRI r.ice:  NOEL  30 tag/kg/day.

               d.   Xhera et al. (1979), a  rat oral  fetotoxicity study
using 50 percent formulation expressed  as active ingredient:
NOEL 12. 5~ mg/kg/day.—'

               At doses greater than 5  mg/kg,  the major  fetal  effect was  an
increase in, skeletal variations (extra  ribs) as compared to  controls.   This
determination was complicated by the following two factors:  (1)   often the
percentage of fetuses having an extra rib was  within a so-called normal
range of 3-41 percent (20 percent average)  for CD rats, and 25-75 percent
(47 percent average) for New Zealand white  rabbits;—   (2) except in
Xhera et al.  (1979), the litter was not used as the  unit for statistical
analysis.  Because of the possibility that  a disproportionate  number of
affected fetuses might belong to a single dam,  the litter, rather than the
entire number of fetuses per dose level/ is the preferred unit for
analyses.  Approximate margins of safety for fetotoxicity as calculated by
the Agency are presented, use by use/ in Table 11-11.

               Given a total dietary exposure,  under current use patterns,
of 0.003 mg/kg/day, dietary risk of fetotoxic  effects is estimated in terms
of an approximate margin of safety of 800,

          3.   Risk; Acute and Subacute Central Nervous  System Sffects

               Available studies in humans  and in diverse species of ani-
mals (dogs, rats, rabbits, frogs, chickens) report notably parallel results
in connection with the acute and subacute toxic effects  of lindane.  [Refer
to Subsection II.A.4.c.(4) and Table II-5.]  Lindane has been  shown to have
an affinity for the fat-rich (white) nerve  tissue, where it  accumulates and
causes symptoms of acute and subacute poisoning which are typical of cen-
tral nervous  system (CHS) stimulation.  Actual symptoms  correlate closely
with theoretical mechanisms as well as  aecnanisms observed in  vitro in
various nerve types.  Laboratory and epidemiological evidence  has been
reinforced by clinical findings (including  tissue residue analyses)  in
conjunction with the recent death of a  two-and one-half  month  old infant
—/  Palmer -and Lcvall  (1971),  ?aliner  and Neuff  (1971),  and Bauer
     and Frohberg  (1972) were submitted by  Hooker  Chemicals during the
     rebuttal period.   (Refer to Table II-3.)  Xhera  et  al. (1979),  an
     additional study discovered and reviewed  by the  Agency during the
     rebuttal period, is addressed  in  Subsection II.A.2.f  above.
20/ -
—   Palmer, A.X.  Sporadic Mai formations  in Laboratory Animals
     and their Influence on Drug Testing Advances.  E;
-------
who had been treated for scabies with a commercial  lindane  product.   A 110
ppb concentration of lindane ^3 .the child's brain was  established as  the
most probable cause of death.—

               Symptoms in animals appear  in  the following  order:   1)
increased respiratory rats, 2) restlesness, 3)  intermittent muscle spasma,
4) salivation, 5) disequilibrium, o) convulsions, 7)  collapse,   and 8)
death.  Symptoms of acute poisoning in humans are similar to those dis-
played in laboratory animals and occur in  this  order:  1) dizziness, 2)
headache, 3) nausea and vcmiting, 4) diarrhea,  5) tremors,  5) weakness, 7)
convulsions, 3) dyspnea, 9) cyanosis, and  10) circulatory collapse.

               3ased on Hayes  (1963), the  Agency has  determined an approxi-
mate no observable effect level (NOEL) in  adult humans  of 2.5 tag/kg/day.
To recapitulate, Hayes observed the following results  when  100  percent
gamma isomer (lindane) was tested in humans:  0.66  mg/kg/day x  14  days—no
effect: 2.3 mg/kg/day x 3 days—no effect:  3 mg/kg/day repeated—dizziness
and diarrhea after several days.  These findings correlate  closely with the
reported findings of Desi  (1974), in which dosages  of  2.5 mg/kg/day adminis-
tered to Wistar rats induced no pathological  effects  but triggered in-
creased irritability as measured in performance tests.

               A NOEL of 2.5 mg/kg/day for adult humans is  inevitably a
rough approximation, and the following points should  be emphasized:

               a.   Effects at low dosage  levels may  be reversible.

               b.   Subtle, sub-symptomatic effects may occur below 2.5
mg/kg/day, and these changes could affect  the functional efficiency of
nerve transmission.

               c.   Among adults there may be a high  degree of  variation
in sensitivity to the CMS effects of lindane.

               d.   Sensitivity in the young  may be considerably greater
than that of adults (Hanig at  al., 1976).

               Thus a NOEL of  2.5 mg/kg/day may well  be underrepresentative
for certain subgroups of the population, especially children, who  might be
particularly sensitive to  the  toxic effects of  lindane.—    It  should
be pointed out also that workers whose functions call  for a high degree of
—   Other lindane-related  deaths have  been  reported,  but  only in
     connection with  this recent instance were  the  results of  tissue
     analyses available.   [Refer to  Subsection  II.A.4  above and Hayes
      (1963).]

22 /
—   In  connection with  the various  pet uses of lindane,  the Agency
     is  also concerned about the potential acute  effects  of lindane to
     young animals.

-------
nerve-motor coordination might experience  decreased  efficiency at unspeci-
fiable doses below 2.5 mg/kg/day.:i—

               Acute and subacute CNS risk  to  humans  has  been evaluated by
comparing a 2.5 ng/kg/day NOEL with the highest estimated daily acute expo-
sure for each use of lindane.  The resultant margins  of  safety (MOS)  repre-
sent rough measures of risk to exposed adult populations.   (See Table
11-11.)  3ased on available data, specific  margins of safety  for children
could not be calculated but are likely to be considerably lower than  those
estimated for adults.

               Given a total dietary exposure, under  current  use patterns,
of 0.003 mg/kg/day, dietary risks of CNS effects are  estimated in terms of
an approximate margin of safety of 1600.
23/     ?or the pineapple use, the margin of safety for acute  and  fetotoxic
        effects is sufficiently high  (2.3 x 10  ) and  (4.5  x  10*),
        respectively, that the possibility of adverse effects  and  acute  and
        fetotoxic effects is extremely slight.  Under Agency regulations,  a
        presumption for an acute effect may be  rebutted when it  is  shown
        that the pesticide "when considered with the  formulations,
        packaging, method of use, and proposed  restrictions  on and
        directions for use and widespread and commonly recognized practices
        of use, the anticipated exposure to an  applicator  or user and  to
        local, regional or national populations of nontarget organisms is
        not likely to result in any significant acute adverse  effects"
        [subsection 162.11(a)(iii)(4)(i)].  A chronic effect presumption
        such as fetotoxicity may be rebutted "when considered  with  the
        proposed restrictions on use and widespread and commonly recognized
        practices of use, the pesticide will r.ot concentrate,  persist  or
        accrue to levels in man or the environment likely  to result  in any
        significant chronic effects"  [subsection 162.11(a)(4)(ii)].  In
        view of the exceptionally high margin of safety for  the  acute  and
        fetotoxic effects for pineapples, the rebuttable presumption
        against registration for these effects  on the pineapple  use  has
        been rebutted.

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III.  BENEFIT ANALYSIS

     A.   Introduction

          Material presented  in  this  section  is  based primarily on an in-
depth Preliminary Benefit Analysis  of  Lindar.e  (PSA)  (EPA 1978f); it is not
based on an alternative version  prepared  by USDA in  October, 1979.  The
approach taken in this joint  EPA/USDA  effort was to  evaluate the.economic
benefits of lindane in terns  of  the economic impacts which would result if
lindane uses yere cancelled,  and users  were forced to employ available
alternatives.—   Economic impacts were  calculated at the user level on
a use-by-use basis.  Impacts  at  the commodity  and consumer levels were then
projected, where appropriate.  The  analysis was  based on the most recent
data available (1975-1977).   Estimated  impacts are expressed in 1977
dollars.  However, data on  the extent  of  pest  problems and pest control
methods are exceedingly limited.  This  necessitated  a number of assumptions
in connection with the potential total  effects of cancelling lindane.
Therefore the estimates are rough approximations and subject to revision if
data become available.

          As Table III-1 shovs ,  three  uses account for 87 percent of an
approximate total of 901,000  to  937,000 pounds of lindane used each year in
the U.S.:  seed treatment (48 percent), hardwood lumber (22 percent),  and
livestock (17 percent).  The  major  economic impact from the cancellation of
lindane would fall in the hardwood  logs and lumber industry.  A major
impact is possible in connection with  lindane  seed treatment, but data
limitations have precluded  any assessment in quantified terms.  Moderate
impacts are estimated for the ornamental,  cucurbit,  and Florida avocado
industries.  In general, minor impacts  are projected in the forestry and
Christmas tree industries,  although individual growers could experience
major impacts.  All other users, including livestock farmers, would
experience only minor economic impacts.  Should  all  uses of lindane be
cancelled, total quantifiable yearly  impacts are estimated at 5181,000,000.

          The projected major and minor impacts  derive primarily frcm a
lack of adequate alternatives to lindane.  For some  uses, there are no
known alternative control methods for  the  target pests.  For some other
uses, the alternatives are  reported to  be ineffective or to affect product
quality.

     3.   Underlying Assumptions and  Limitations

          In addition to specific limitations  noted  in the individual
analyses presented in the subsections  below,  certain general limitations
wera common to all analyses of lindane  uses.   These  are as follows:

           1.   Published data or experimental  results identifying yield
changes were generally unavailable.   Therefore,  expert  opinions of
knowledgeable persons familiar with lindane  use  served as the bases of
economic impacts.

          2.   Published data specifying  alternate insect control
strategies for each use were  unavailable.  Expert opinion was used to
Generate imcacts of alternate control  strateaies.
      Alternatives  were  identifies
frcm lists cf EPA-racistered testicices
                                   ill
                                      T-l

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                                   Table  1II-1.  Summary of  Benefit  Analysis

Extent of Use Availability
A.I. pounds Treatment Units ot" Economic
list: Sil.e .mil (M* (II Units) Alternatives
Hardwood 200,000 3,365,705,000 None
l.umli.ji (22t) board ft

Seed -126,000 13,01)9,000 acres None for
'IY.JU Lmen t (-Ib'-t) small grains; small
(sm.iU. 3,000,000 acres grains;
gra.inu corn several for
and coi:i>) corn


Avo.--a.los 7,000 7,000 acres Hone for
(I1-*.) mi. rids;

1-1 several for
, webbing
IXJ worm
Orn.imentals 17,000 3,630 acres Mo alterna-
(cuiiiniiii.-c ia 1 (2'i) tives for
cind hous»i-- most pests
hold ns<::i)


Cni;nr:l)i t;s 11,000 11,600 acres Alternatives
( 1 t) exi st witli
varying
levels of
efficacy
Clir i st mas Unknown llnknovyfi Chemical
Trues alternative
l:or white
pine weevils
only; cul-
tural alter-
nfiti ves not
evaluated

Economic
Extent
Nature ($/year)
Yield S $147,020,000
quality
loss
Yield Not
loss for quantifiable
small except for
grains, corn
lentils, ($690,000)
and dry
peas
Yield B, 700, 000
and

quali ty
loss

Produc- 20,600,000
tion
cost in-
crease &
yield
loss
Produc- 176,000
tion cost
i ncrease
& yield
loss
Produc- Mot quanti-
t:ion fiable
cost In-
crease t
yield
loss


Impacts


Significance Social Community
Major


Possible major
impact for small
small grains,
lentils, and dry
peas; minor for
corn

Moderate Regional impact in
Florida




Moderate Regional impacts on
landscape configuration;
property losses to
homeowners


Minor




Major to Possible regional hired
some indi- labor impacts, parti-
vidual cularly in the Lake
growers; States
aggregate
impact not
estimated

Dm: to round.-d calculations, percentages add up to 99.6 percent  total.

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                                          Table III-l.  Summary of  Benefit Analysis  (Cont.)
t-i
n
»-i
 I
L.J
	

A
Use Si te
Pecans





Forestry




Livestock



Structures



P i iiucippl es









" "
Extent of Use
. I. pounds Treatment Units
and (%)* (II Units)
33,600 440,000 trees
(44,)




4 , 000 Unknown
(0.54)



140,000 - 20,122,000
1.76,000 head
(I'M)

1,000 10,000
(0.14) homes


19,000 9,650 acres
(24.)









Availability
of Economic
Alternatives
Alternatives
exist with
varying
efficacy


Alternatives
only partly
replace
lindane in
forest mcjmt
Alternatives
generally
available &
efficacious
Equally ef-
fective al-
ternatives
exist
None to
replace
i.ts role
in dual
treatments;
UDCP £, EDO.
offer some
anti-
symphylid
control.
Impacts
Economic
Extent
Nature ($/year) Significance Social Community
Produc- $1,374,000 Minor
tion
cost in-
crease &
yield
loss
Yield & Not quanti- Minor
quality fied



Produc— $1,003,000 Minor
tion
cost
increase
Possible Near zero Minor if Possible labor £
cost in- PCP is community impacts if
crease available there are multiple
adverse UPAK decisions
Yield $1,018,000 Minor Possible labor &
loss (4 years) community impacts if
there are multiple
adverse RPAR decisions







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Table III-l. Suimuary of Benefit Analysis (Cont.)
Impacts
Extent of Use
A.I. pounds Treatment Units
Us«j Site and Cl) * (II Units)
Pots 30,000 Unknown
(3'i)
I) Pel:
Col liiirs
2 ) 1 )o. j
Wash
3 ) 1 K >i |
•1)|KK)
Dust
Household 12,000 Unknoxvn
1 . Shell: (1'i)
P.I per
2. k'loor
Wax
Availability Economic
of Economic Extent
Alternatives Nature ($/year) Sicjnif icance Social Community
Several ef- Possible Near zero Minor
fective al- cost in-
ternatives crease
available





Several ef- Possible Near zero Minor
fective al- cost in-
ternatives crease
available

|-J    3.  I Ion se-
ll        Iml,I
 I         ..........
'1 . t'uiii i -
ij
-------
n
M
l-l
 I
(Jl
U;jc SJ te
     3 .  Empty
        Stor-
                              _ Table  ITI-1.   Summary of Uc:ne£it Analysis (Cont.)
                                                                                          Impacts
                        I2xtcnt of Ilao            Availability
                A.T.  pounds   'I'rcatnujnt  Uni.ts   ot" Economic
                 and  Ci)*         (If Units)       Alternatives   Nature
                                                             Economic
                                                          Extent
                                                         ($/year)	Significance
                                 Social Couununity
       Bin

       Fuij
       SpTcl y	
    All
900,600
036,600
$180,868,000

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          3.   In cases of unknown insect activity  levels,  it  was  assumed
that infestations were more severe in climates known to be  conducive  to the
insect and less severe in inhospitable climates.

          4.   Because of the imprecise nature of the  data  used  to
determine effects on yields and prices, the  analysis fccused on  direct
impacts to users.  No attempt was made to quantify  impacts  beyond  this
level.

     C.   Hardwood Logs and Lumber

          1.   Usace
               Lindane, the gamma  isomer  of  3HC,  is  registered for control
of the following pests on logs and lumber:   1)  bark  beetles,  including pine
bark beetles; 2) wood-boring insects,  including wood-boring beetles,
flatheaded wood borers, round-headed wood borers,  powderpost  beetles,
lyctus beetles, and ambrosia beetles.  The powder-post  and lyctus  beetles
are drywood pests only; the remainder  attack logs  and  lumber  only  after the
moisture content falls below 48 percent.

               SPA is at present allowing lindar.e  to be substituted for
3HC, which has been cancelled, in  products registered  for  use on logs  and
lumber.  Mill owners are currently phasing in lindane  as a substitute  for
BKC in their pest control programs.  Due  to  the present changeover, actual
figures for  lir.dane use are unavailable.   It is assumed, however,  that
lindane will entirely replace  3HC.  Consequently,  the  figures given in
Table III-2  should be regarded as  applicable to lindane per se,  although
they are expressed in terns of both  lindane  and 3HC.

               Data are unavailable  on the extent to which lindane is
actually used to treat lumber  in sawmills.  The estimates  given in Table
III-2 below  have been developed by the Agency.  The  estimates presented do
not include  usage on hardwood  logs because no data are  available.
Therefore, logs were not included  in  the  benefit  analysis.  The remainder
of  this section deals  exclusively  with lindane application to lumber .—

          2.   Alternative Methods of  Control

               No chemical controls  other than lindane  are registered for
acolication  to green lumber to control ambrosia beetles or flatheaded and
roundheaded  borers, which are  the  pests  of main economic importance to the
hardwood sawmill  industry.  Copper naphthenate is registered to control
powderpost beetles on  lumber.  ?entachiorophenoi  (?CP)  is registered to
control3wood-bcring beetles on logs  and pcwderpost and lyctus beetles  on
lumber.—
 2/   Hefer to ?3A (2?A 1973f),  pp.  51-57.

 2/   Pentachioroohenol is currentlv under RPA5. review.
                                    III-o

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Table IIJ-2.  Use (in Pounds) of Fortified UIIC and Gamma Isomer  to Treat  Green Hardwood Lumber - 1975	
                     	High Est imate	     	Low Estimate	Mean Estimate	
Uegion of U.S.       t'UIIC*       Gamma Isoiner     FBIIC      Gamma Isomer    FBIIC        Gamma Isomer
North Central        201,700       04,700         02,200       34,500        142,000      59,600
 t Northeast

South                373,900      157,000        284,900      119,600        329,400     130,300

 Total
Eastern U.S.         575,700      241,700        367,000      154,200        471,400     190,000
^Fortified benzene hexachloride (FUI1C) contains approximately 42-43  percent gamma isomer.

     a/        The range presented in Table TII-2 is based on the  total
     -"—
               estimated volume of lumber treated.

     b/        According to the Bureau of Census (1976), 97 percent  of
               hardwood produced i.n this country came from the  Eastern U.S.
               as comprised o£ two regions:  1) the northeast and  north
               central region (35 percent) and 2) the southern  region  (62
               percent).  As defined by the Bureau, the northeast  and
               north central region consists of Maine, New Hampshire,
               Vermont, New York, New Jersey, Pennsylvania, Ohio,  Indiana,
               Illinois, Michigan, Wisconsin, Minnesota, Iowa,  North
               Dakota, Nebraska, and Kansas; the southern region consists
               otr Delaware, Maryland, District of Columbia, Virginia, West
               Virginia, North Carolina, South Carolina, Georgia,  Florida,
               Kentucky, Tennessee, Alabama, Mississippi, Arkansas,
               Louisiana, Oklahoma, and Texas.

-------
               For the most economically  important  hardwoods  (oak,
gum, cottonwood, hickory, and elm), which constitute  65  percent  of  the
total hardwood production, there are no non-chemical  control  methods  which
do not reduce the lumber quality to below marketable  levels.   For other
hardwoods, there are non-chemical methods including kiln-drying, and  "snd-
racking" (rapid no-heat curing).  End-racking produces warping and  cracking
which severely reduces lumber quality.  Kiln drying introduces a 10-15
percent deterioration to those species which can be kiln dried.  Kiln
drying is most effective for northern hardwoods, principally  maple, and  is
generally less effective for southern hardwoods where the insect problem is
most severe.  This coupled with the high  cost of kilns makes  this control
method impractical.

          3.   Economic. Impacts

               According to the National  Forest Products Association
(NFPA), the hardwood sawmill industry is  characterized by snail  family-
owned mills (NFPA, 1977).  These mills are generally  each capable of
producing 10,000,000 board feet of lumber annually.

               Impacts from cancellation  of lindane were estimated  based on
production costs of $163 per 1,000 board  feet, gross  revenue  of  $193  per
1,000 board feet, and estimates of loss provided by the  NFPA.  These
impacts are shown in Table III-3.

               Estimates of the total impact to the hardwood  Industry
should lindane be cancelled are given in  Table III-5.  The impacts  were
calculated from the average loss figures  shown in Taile  III-3  and the esti-
mates of total lumber treated with 3HC and lindane  given in Table III-4.
The estimates are presented in terms of ranges as well as most likely
estimates.

               Given the absence of chemical alternatives,  and given  the
infeasibility of the limited non-chemical alternatives,  the eccnomic
Impacts experienced by the hardwood lumber industry are  expected to be
substantial should lindane be cancelled.
     D.   Seea Treatment  (Small Grains, Corn,  Lentils,  and Drv Peas)
          1.   Usace
               Lindane  is registered  as  a  seed  treatment  for small grains
 (wheat, barley, oats, and rye), corn,  and  ether  crops  such  as  sorghum and
 a number of vegetables.  Lindane  is generally  formulated  in combination
 with a fungicide and applied  to the seed as  a planter  box treatment.—'
4/
-   When plateless or  air planters  are  used  for  corn,  planter hex treat-
    ments may  become ineffective  because  of  the  loss  of  pesticide remaining
    on  the  seed  (3oce  et ai.,  1976).  Air and  piateless  planters are ~ore
    efficient  than conventional plate planters.   As  the  new air and piate-
    less planters  replace conventional  planters,  the  acreage which could be
    effectively  slanted with  olantar box  seed  treatments will diminish.
                                    III-3

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Table Til- 3.  Expected Values ($) V
              I'er 1,000 Board Feet—
                                           anc* Without Chemical Peat Control of  Hardwood Lumber



H
M
H
1
Species— B1K
1U;<1 dak
Ucip Gum
Wi: i qhteii
Average

a/ Estimates

Expected Val
Lindaue or No Control
: Control Moderate Attack
194.00
153.00

190.00

were rounded
172.00
141.00

170.00

to the nearest
ue
No Control
Severe Attack
138.00
120.00

137.00

dollar.
Value
No Control
Moderate Attack
22.00
12.00

21.00


Loss

No Control
Severe Attack
55.00
33.00

54.00








b/   Species chosen were felt to be representative of all hardwood species.

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                          Table  Tir-4.   Estimated  Lumber  Treated  by Region  in  U.S.  -  1975.




M
l-t
M
1

l(c>j ion
Noi.'theast
ami North
Collt I'd 1
South

Lumber
Product ion
1000 bd. ft.
1,778,500


3,170,300
Estimated
% Lumber Treated
Min Max Mean
% % %
treated treated treated
33 81 57


64 84 74

Estimated Lumber
(1000 bd.
min max
586,900 1,440,600


2,034,100 2,669,800

Treated
ft.)
mean
1,01 3,700


2, 352,000
O

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            Table Tl'I-5.  Economic Dollar Impacts on the Sawmill Industry —'
                                                                          a/
                   Per Average Mill           Total Per Region     Most Likely
                 Mini mum       Maximum	Minimum	Maximum	Total Impact
Northeast £,     119,027
  North Central
South

Eastern U.S.
  Total
154,526
306,001    21,168,900     54,244,000    21,168,900


395,966    49,113,900     125,851,100  125,851,100

          70,282,700     180,095,200  147,020,000
a/  Hounded to the nearest $100.

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As a seed treatment, lindane is used to control wireworms,  seedcom  beetles,
and seedcom maggots, sporadic pests which cause non-germination of  seeds
or weak seedlings.  The treatments are made primarily as  insurance against
potential damage and afford protection to the seed and ensure germination.
However, under high levels of soil pest infestation the seed treatment  does
not protect newly emerged roots or shoots which are also  subject to  attack
by wireworms and additional pests.

               As Table III-6 shows, approximately 426,000  pounds of
lindane are used annually for seed treatment.  Of that total, about  31
percent is used to protect small grain seed from the wireworm complex,  and
about 15 percent to protect corn seed from wireworms, seedcom maggots,  and
seedcorn beetles.  An additional 3 percent is applied to  lentils and dry
peas.  Because small grain (primarily wheat), corn, lentil, and dry  pea
seed treatments comprise 99 percent of total lindane used for seed treat-
ment purposes, this analysis focuses on these applications.  Approximately
13.1 million acres of small grains are planted with lindane treated  seed
annually.  Approximately 6.0 million acres representing 39  percent of North
Dakota small grain acreage and 1.3 million acres or 55 percent of the Idaho
small grain acreage are planted with lindane seed.

          2.   Alternative Methods of Control

               Heptachlor is presently registered to control the same
spectrum of pests as lindane on small grains and corn.— ,   There are  no
other viable registered alternatives to lindane for small grains.  However,
viable alternatives are registered for seed treatment of  corn.  Diazir.on is
registered as a corn seed treatment to control seedcom maggots and  seed-
corn beetles (and as a soil treatment to control wireworm).  Chlorpyrifos
is registered as a seed treatment to control seedcorn maggots, but it is
not registered to control wireworms or seedcorn beetles.   Other alternatives
to control the soil insect complex in com are available,  but these  are  for
soil application (ore-plant) and not as seed treatments.
                                                                  6/
          3.   Sfficacv of Lindane Seed Treatment and Alternatives—

               The efficacy of lindane used a seed treatment has been demon-
strated  in numerous studies and for a variety of crops including small
grains and com.  Studies were conducted by:  Dogger and  Lilly  (1949),
Hocking  (1949), Cwen (1950), Slmore (1953), Kulash (1953),  Frost, .Anderson
and Slmore  (1954), Hastings and Cower. £1954), Ditman, Cox and Kantzss
(1955),  Daniels (1955), Kulash and Monroe (1954 and 1955),  Hoffmaster and
Mugent  (1956), Lilly (1955), Xuiash (1956), Bowling (1957), Harvcod,
Mel sen  and Talford  (1957), Apple, Strong and Raffensparcer (1953), Long  and
—  The  Tinal Order  of  the Administrator  in  the Chlordane/Heptachior
    Cancellations  (signed March  6,  1973)  phases out  this  alternative,  and
    heptachlor  use on barley, oats, wheat, rye, and  corn  will  be  cancelled
    effective September  1, 1932.
6/  _      .   .           	
—  iccncmic data  summarized  in  tr.is  subsection r.avs ceen aeve_ocec
    3UDolemental  to  the  Preliminary Benefit  .-.nalvsis of Lindane (?3A

-------
   Table III-6.  Estimated Annual Use of Lindane  as  a  Seed Treatment,
                 by Crop - 1976.
Croo
Small Grains
Wheat
Barley, oats and rye
Corn
Lentils and dry peas
a/
Other crops-
Totals
Lindane A.I.
( Pounds )
344,400
(250,400)
(94,000)
64,300
11,000
5,900
425,600
Percent Used as a
Seed Treatment
81%
(59%)
(22%)
15%
3%
1%
100%
a/
—   Includes dry beans, sorghum, sunflowers,  sugar  beets,  and
    vegetables .

-------
Lilly (1953 and 1959), and Bigger  and  Decker  (1966).   While the efficacy
data support the effectiveness of  lindane  seed  treatments at low to
moderate levels of infestation,  it  has  been  shown that under heavy infesta-
tions of wireworms, wireworms not  killed or  repelled  at planting time or
during germination, may ultimately reach sprouts  or seedlings (Xulash,
1953).

               One of  the most recent  studies  was conducted in Washington
in 1977-1978.  The study  evaluated 20  different compounds as seed coatings
to dry land wheat  for  control of wireworas.   Only three compounds provided
statistically significant increases in  plant  stand counts as compared to
the control.  These were:  lindane, chlordane,  and heptachlor (Perkins and
Harwood, 1979) .

               Agriculture Canada  has  submitted unpublished test data to
the Agency which evaluate the effectiveness  of  lindane seed treatments of
cereal grains and  rape.  The test  data  spanning 1952-1976 show the
effectiveness of lindane  in reducing wireworm  populations and improving
stand counts (3urrage, 1980).

          4.   Economic Impacts

               Very little biological  information is  available which is
necessary to cuantitatively estimate the economic impacts of a lindane seed
treatment cancellation on small  grains, lentils,  and  dry peas.  Although
the efficacy of lindane in improving stand counts and reducing wireworm
damage has been quantitatively demonstrated,  other critical information has
not been developed.   Tor  example,  information  relating stand counts to
yield losses is not available, nor is  information relating yield losses
with varying intensity of wireworm infestations in relevant geographic
locations available.   Data identifying the frequency of infestations
exceeding the economic thresholds  for  various  crops in various locations ar=
not available, and data indicating the efficacy of lindane with varying
levels of pest infestation have  not been developed.

               The lack of  biological data  on small  grains, lentils, and
dry peas has severely  hampered economic impact analysis, since the expected
value of yield losses  over time  cannot be  estimated and alternative
chemicals are not  available to control the soil pests.  Therefore, economic
impacts can  only be qualitatively  estimated  for these crops.  In the case
of com, chemical  alternatives are available and expected yield losses can
be estimated; therefore quantitative economic estimates have been mace.

               Corn '^

               Lindane is  applied  to corn  seed at a cost of approximately
SO.15 per acre—  .  Diazinon seed treatments  can be substituted for
lindane seed treatments at a  cost  of approximately SO.20 per acre where
seedcorn beetles and  seedcorn maggots  are  the pests requiring control.  The
substitution of diazinon  seed  treatments  for lindane  seed treatments would
result  in increased chemical  costs of  $190,000 annually on the 2.S million
acres of corn  olantsd with  lindane treated seed.
 —  iconcmic  data siimmarized in this subsection nave been developed
    sucolamentai  to the Prelir.ir.arv Benefit .-.r.alvsis if Lindar.e  (Z?A  1973 )
 —  All costs  are in 1977 dollars.

-------
               However, diazincn  seed  treatments  do not effectively control
wireworm damage.  It is estimated   that  approximately 1 million corn acres
or less are infested with wireworms  annually.   Most of this acreage is
currently treated with soil insecticides.   It  is  estimated that
approximately 100,000 acres infested with  wireworms would not be treated
with soil insecticides and would  be  infested with wireworms resulting in
yield losses.  Yield losses are anticipated to average approximately 2
bushels per acre based on U.S. average corn yields of 93 bushels per acre
(1976-1978) and a 1966 study performed in  Illinois where an average yield
increase of 2.2 percent was reported for the seed treated versus untreated
plots (Bigger and Decker, 1966).

               Assuming corn prices  of $2.50 per  bushel, yield losses
combined with increased treatment  costs  would  average approximately $5.05
per acre on the 100,000 wirewcrm  infested  acres.   On the remaining 3.7
million acres increased costs of  $0.05 per acre would be experienced.
Aggregated user costs for the cancellation of  lindane on corn seed are
estimated at $690,000 per year.   The level of  production losses anticipated
(less than .003 percent) is not expected to result in economic impacts at
the market or consumer level.

               Small grains

               Growers are currently treating  small grain seed with lindane
at costs ranging from approximately $.20 per acre for winter wheat to $.46
per acre for barley.  Lindane is  applied to protect the seed from wireworm
damage.  There are no alternative  chemicals available other than heptachlor
for wireworm control for small grains.

               For the reasons described at the beginning of this Economic
Impacts section no quantitative analysis of impacts is possible.  However,
the potential for impacts can be  described qualitatively.  Should lindane
be cancelled, economic impac-s would most  likely  fall into two patterns :

               a.    Fields planted without pesticides and damaged by pest
infestations might be replanted if timing  and  other environmental factors
were favorable.  The estimated cost of replanting an acre of wheat is
about $12.00, including machine operation, labor, and seed.  Replanted
fields may also experience yield  losses  because of insects and less
favorable germination and growing periods; the frequency and damage of
these losses cannot  be determined.

               b.    Insecticidal  treatments would not be made and sporadic
yield losses would result, but for any of  a variety of reasons, the damaged
area would not be replanted  (the  frequency and magnitude cf these losses
cannot be determined).
                                   111-15

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               These two outcomes point  to  a potential for economic impacts
en small grains currently planted with lindane-treated seed.   Of the
grains, spring-planted small grains  could be seriously affected, and this
would be felt most severely in North Dakota,  Idaho,  and Minnesota,  where
wireworm infestations are most severe and where  50  percent of spring-
planted grains are grown.  An estimated  12-percent  of  U.S. small grain
acreage is planted with lindane-treated  seed;  however, as much as 30
percent of U.S. spring wheat acreage is  planted  with treated seed.   In
North Dakota and Idaho 30 percent and 55 percent of the small grain acreages
are with lindane-treated seed, respectively.   Should lindane be
cancelled, and should extensive wireworm damage  result, major regional
impacts are possible for spring-planted  small  grains at the user level.  If
significant production losses were  to occur,  cancellation could also result
in potentially major spring-planted  small grain  market level impacts.  The
Agency has not found nor have data  been  submitted to estimate the likelihood
or magnitude of this occurrence.

               Lentils and Dry Peas

               Approximately 3 percent of lindane seed treatment formula-
tions are applied to lentils and dry peas,  crops which are commercially
produced only in Idaho and Washington.   About  35 percent of lentil  acreage
and  100 percent of dry pea acreage were  planted  with lindane-treated seed
as insurance against wireworm damage.

               No alternatives to  lindane  seed treatment are available for
these two crops.  Data on possible  yield losses  from wireworm infestations
are  not available.  However, given  the high percentage of lindane seed
treatment en lentils and cry peas  — depending upon the extent of wireworm
damage which might otherwise occur  — cancellation  rr.ay result in economic
impacts at the user and market levels.   The Agency  has not found, nor have
data been submitted to estimate  the  likelihood or magnitude of this
occurrence.

     E.   Avocados

          1.   Usage

               Lindane replaced  3HC  on avocados  after  the cancellation of
3HC  and is used extensively  in Florida to  control mirics and webbingwortrs •
Approximately  7,000 pounds  of  lindane are  used on about 3C percent of  the
crop in Florida to control  these pests.   Florida avocado production
currently represents  roughly  22  percent  cf  U.S.  avocado production.
Lindane is net used en avocados  in  California (the  other domestic producer)
because mirics are not pests  of  economic significance  ir. that state.

          2.   Alternative  Methods  cf Centre!

               There  are  no  registered  chemicals for mirid control except
lindane.  Parathicn is registered  to control webbingwcrms.  There are  no
non-chemical  control methods  which  produce  a marketable crop for the fresh
avocado market.

-------
               Preliminary  results  of  a  nearly completed study indicate
that acephate and permethrin are  effective  materials  for mirid control.
Neither is currently registered  for  this  use.   Permethrin seems to have
residual effects ecual to those  of  lindane.   The residual effectiveness of
                                     9/
acephate is reportedly much shorter.—

          3.   Economic Impacts

               A lack of hard  data  exists with which  to quantitatively
evaluate fruit losses (downgrading  or  complete loss due to fruit drop)
resulting from mirid damage in the  absence  of  lindane.   According to state
experts, the economic impacts  frcm  cancellation are estimated as a
possible loss of 70 to 80 percent of the  Florida avocado crop, though loss
of early varieties could approach  100  percent.  Loss  is a combination of
physical damage and/or cosmetic  scarring  which can lower grade.  While a
percentage of damaged crops would be sold to  avocado  processors, this would
not offset the loss incurred by  diminished  sales to  the fresh avocado
market.  Currently, the processed fruit  market absorbs  only about 5 percent
of Florida's avocado production.

               According to local experts,  —  losses  would approximate
22,000 tons of avocados at  a cost to users  of  $8.7 million assuming no
change in grading standards. —   If  these standards were relaxed the
proportion of the loss attributed to cosmetic  damage  frcm mirids would be
reduced.

               The anticipated losses  are strictly frcm lack of mirid
control.  As an alternative and  anti-webbingworm pesticide, parathion
causes no substantial economic impacts.

     F.   Ornamentals

          1.   Usage

               Lir.dane is used on a variety of woody  ornamentals and floral
and foliage plants to control  primarily  borers, thrips, and Isafminers.
Actual usage data are unavailable,  and the  estimates  submitted by Hooker
Chemical (74,840 pounds), USDA (13,402 pounds), and  the National Arborist
Association  (3,580 pounds)  vary  greatly.   Moreover,  the USDA estimate is
based  solely upon reported,  use in only 6  states .
9/
—   NOTE:  These  are  preliminary results of a laboratory study and not
    a small plot  field  trial.
10/
 —   A.  Sarano'^s ki ,  Florida  State Dept.  of Entomology; H. Goicveoer.
 —   rnu.
      The  gradinc  standard for  avocados is at 22 FR 6205.

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          2.    Alternative Methods of Control

               Lindane is the only pesticide presently  registered to
control all borers on all wcody ornamentals.   Chlorpyrifos  and endosulfan
are registered for borer control only on selected  species of  ornamentals•
Alternate pesticides are generally available for the  pests  of floral and
foliage plants presently controlled by  lindane.

          3.    Economic Impacts

               Because data were unavailable,  a precise quantitative
analysis could not be performed.  Estimates of projected losses are shown
in Table III-7.  These estimates are taken  from reports of  the states which
reported on the USDA information survey.  Total impacts on  the woody
ornamental industry may total 520.6 million dollars.  As a  whole, this is
expected to be of less than major significance to  the industry.  Impacts on
individual firms could be sizable.  Impacts on the floral and foliage
industry are expected to be minor.

     G.   Cucurbits

          1.    Usage

               Lindane is registered for control of  various insect pests
(including aphics, cucumber beetles  [striped and spotted],  cutworms,
melonworms, pickleworms, squash bugs, squash vine  borers, and white grubs)
on cucurbits such as canteloupe, cucumber,  pumpkin,  squash, and watermelon.
Lindane treatment is used on only 12 percent of America's  fresh market
cucurbits .

               Data concerning  lindane  usage on cucurbits  are available
frcm only three states:  Florida  (total cucurbit acreage:   17,900 acres),
South Carolina (total cucurbit  acreage:  14, 600 acres), and Georgia (total
cucurbit acreage:   10,500 acres)—   (See Table III-S).   Twenty-two
percent of the total cucurbit acreage of these states was  treated with
cucumber and squash acreage in  the U.S. As Table  III-3 shows, the common
practice is to apply lindane to cucurbits  frcm one to eight times during
the growing season.  However, experts generally consider four applications
per season to  be sufficient.

          2.   Alternative Methods of Control

               Pickieworms and  squash vine  borers  are the target insects of
main economic  importance on cucumbers and  squash.   Seventeen pesticides
other  than lindans  are Z?A-registered for  use  against these pests en squash
and cucumbers.  USDA recommends carbaryl,  endosulfan, and lindane.
      T .  .          .          ...       .             ,       .   .
—    Lincane  may  aj.so  ce  usea  in otner states to control squasn vine
      borers and pickiewcrms, but no pertinent data are available.
                                  111-13

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                   Til bit;  II1-7.   Summary of Annual Costs for States  Requesting  Use  of Lindane on Ornamentals
                                  (in 1,000 Units)
Lilac Itorer
State on Lilac
1'eiinyyl van ia
Ohio 0.065
Tennessee
1 owa
Ok Icihoma
Maryland 0.200
i ndianu 4.7
Missouri
Gooi 
-------
Table III-3.  Total Lindane-Treatad Cucurbit Acreage, in Pounds A.I. and
              Cost ~ 1976-1977.
                                          State
Item
Florida   South Carolina
Georgia
Total
Total Cucurbit Acreage       27,900

Total Cucurbit Acreage        2,790
  Treated with Lindane

Percent of Total Treated        10%
  Acreage

Number of Applications         1-2

Pound of A.I. Used Per         0.25
  Application Per Acre

Ppounds A.I. Used             1,046

Insecticide Cost            $11,339
               14,600

                  800


                 5.5%


                 7-3

                 0.25


                1 ,500

              316,260
 10,500    53,000

  3,000    11,590


  75.2%     21.9%
      4

   0.25
  3.6

 0.25
  3,000    10,546

336,720  3114,319
                                    111-20

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               According  to  state  entomoicgis.ts,  most growers in Florida
use carbaryl in combination  with endosulfan  and methorayl to control borers
and pickleworms, and the  same  combination  is probably used in Georgia.
Methcmyl is used in South Carolina.   However,  no  data are available on the
extant to which these alternatives  to lindane are presently used, either on
a state or on an aggregate U.S. basis.   All  of  these alternatives,
particularly carbaryl, are toxic to  bees and could conceivably cause yield
losses due to a loss of pollination.—

          3.   Economic Impacts

               There should  be no  overall  change  in the U.S. production of
cucurbits if lindane were cancelled.   Only 12.2 percent of the fresh market
cucumber acreage is treated  with lindane.   Experts from Florida and South
Carolina, the two states  with  greatest cucurbit acreage, estimated that
the use of alternative chemicals would not affect yield.

               As Table III-9  shows,  replacing lindane with carbaryl would
result in slightly decreased annual  production costs; replacing lindane
with endosulfan would increase production  costs slightly; and replacing
lindane with methomyl would  result  in production costs that are approxi-
mately twice the costs of treating  with lindane.

               Florida and South Carolina  entomologists report no antici-
pated yield loss if lindane  were cancelled;  Georgia entomologists In
contrast, report potential yield losses of up to 25 percent.  Assuming no
yield loss in any states, estimated  impact on cucurbit growers should
lindane be cancelled is minor, $176,000, a figure derived from the cost of
alternatives recommended  by  the states (see Table 111-10} .  The estimate
of economic impact, assuming a 25  percent  yield loss in Georgia and a shift
to state recommended alternatives  is  $2.4  million.  The conflict in
estimates is surprising because the  target pests  in ail three states,
namely pickleworms and squash  vine  borers, are the same.

               Furthermore,  Georgia,  the state reporting  a potential
yield loss, is bounded on the  north  by South Carolina and on the south by
Florida, two states reporting  no anticipated yield loss.  Hence, 'in terms
of climate, soil conditions  and other considerations, one would not expect
Georgia  to present a yield  impact  situation that would be very different
frcm the other two states.

               In the Agency's judgement,  the projected yield loss for
Georgia has not been substantiated by supporting documentation that would
be sufficient to override the  conclusion that the yield impact in Georgia
should be similar to the  situation in Florida and Sourh Carolina.  The
Agency feels it must conclude  that the impact of lindane's cancellation in
Georgia would be very minor, until such time as the Agency is presented
with substantial  information to  the  contrary.
—    See  ?3A,  pp.  408-420.
                                 III-2I

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                                     1JI-9.   Treatment of Cost of  I.indane and Alternatives  for Control of
                                               Squash VJne Horer  and  Pickleworm on Cucun\bers and Squash in
                                               Southeastern U.S.
t-i
t-i
n
I
IvJ
to



1 1
1,1
ct
Ki
Mi







lai.'d. i c i du
i ndu ue
u-bui y 1
ldOSU.1 £
;l homyl
p.: 1 
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Table III-10.  Estimated Total Change in Costs of Production and  Revenue  to
               Squash and Cucumber Growers' in Florida, Georgia, and  South
               Carolina - 1976-1977
Site/Pest
and State
Estimated Total Change
in Costs Using Alternatives
Cucumbers
  Florida
  Georgia
  South Carolina

Squash
  Florida
  Georgia

Total
           (-)$96
          $86,880
          $32,580
           $3,183
          $54,060

         $176,507

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     H.   Christinas Trees

          1.    Usage

               Lindane is used to control five major p-ests  which  attack
Christmas trees (pine regeneration weevil, northern pine weevil,  pales
weevil, pine root collar weevil, and white pine weevil).  Little  data  are
available on the amount of lindane used in the Christmas tree  industry,  and
responses to the USDA survey did not provide enough estimates  on  which  to
base assumptions of use.  Therefore, this discussion addresses  all  issues
qualitatively.

          2.    Alternative Methods of Control

               Oxydemeton-methyl is registered for control 'of  white  pine
weevil infestations of established stands of Christmas  trees.   No other
pesticides are registered for control of the other insects  which  infest
Christmas tree stands.

               Non-chemical control methods are available for  some  insect
pests, although at present they are not generally used  because  they  are
labor-intensive and costly.  These include early pruning, cultural  land
clearing, removal of old stumps, and alternate planting sites.   However,
cultural practices, if carried out diligently, are expected to  suppress the
pests  to an acceptable level.

          3.   Economic Impacts

               Without usage data, quantification of overall  impacts is not
possible, but the following statements can be made.  Generally,  oxydemeton-
methyl is about  1.2-2 times the cost per acre of lindane (31.50 - 3.00  per
acre versus $1.30 per acre) and increase in grower costs is $.20  -  $1.70
per acre.  Cultural controls (non-chemical) are costly  insofar as they are
labor-intensive, and the effectiveness of cultural control  methods  is  based
upon the availability of labor.  Xost growers are expected  to  employ
alternate control methods  (chemical or non-chemical) where  feasible, or
shift  Christmas  tree production to tree species (e.g. Douglas  fir)  which
are less susceptible to pest damage.  The most severe impacts  frcm
cancellation  of  lindane would be borne by a few individual  growers  who for
various  reasons are unable  (because of climatic or planting site
limitations)  to adopt alternate controls or species of  tree.   Mo  estimate
can be made of the number  of farms to which this ccuid  happen.

     I.    Pecans

           1.   Usace

               In  response  to a recent CSDA survey,  seven  states (Alabama,
Arkansas,  Georgia, Mississippi, Louisiana, Oklahoma and Texas)  reported
usinc  lindane on  cecan  craves.  The  orimarv use is  to  control  shvllcxera.
                                  111-24

-------
Although lindane is also registered  to  control  shoot curculio on pecan
trees ,  shoot curculio is not an  economic  threat to  pecans and therefore no
pesticides are used to control this  pest.   As  shown in Table III- 11, 33,000
pounds of lindane are used on 447,300 pecan trees.   Collectively, these
states represent 76 percent of the U.S. pecan  production.  No data were
supplied by the states producing the remaining 24 percent of the pecans .

          2 .   Alternative Methods of Control
               Alternative  feasible  pesticides  currently include malathion,
oils, and endosulfan. —   However, no  data  are  available to determine
the extent of use of any  alternate chemical.

          3.   Economic Impacts

               The  comparable  costs  of treating pecans with lindane and the
alternative chemicals of  choice,  namely endosulfan,  oil ( dormant) ,  or
malathion, are listed in  Table  III- 12  and  111-13.   Growers who
substitute endosulfan for lindane would experience decreased seasonal
pesticide costs of  23 cents  a  tree.  The use  of oil  (dormant)  as an
alternative for lindane would  result in an  increased seasonal  cost of 51.18
per tree^ malathion use would  cost $7.00 more than lindane per tree each
season.—^   The owner of  a  hypothetical 20-acre pecan grcve with 12
trees per acre would save $55.20  if  endosulfan  were  substituted for
lindane; by using oil, the  same  owner  would occur  an additional cost of
$283 over lindane.  If malathion, the  most  expensive alternative, were used
and all other variables of  production  remained  constant, 'this  owner would
incur an additional cost  of  $1,685 per year.

               Entomologists consider  endosulfan to  be as  effective as
lindane, and no yield losses are  anticipated  if endosulfan entirely
replaces lindane.   Endosulfan  is  registered for pecans under FIFRA 24(c) in
Mississippi or Louisiana  and has  Federal registrations for other crops .  In
view of endosulfan1 s regulatory  history, it is  appropriate to  consider
endosulfan a viable, registrable  alternative  for lindane on pecans.  The
Agency expects that endosulfan  would become,  in most instances, the
 14/
—    iRcosulran  is  registered  under FIFRA 24(c)  in Mississippi and
      Louisiana.
 15/
—    Frcm pecan  crop  budgets developed at the university of Georgia,
      total  fixed  and  variable  costs per acre (excluding land and irriga-
      tion)  are 3538 per  acre per year.  Total costs to pecan growers would
      increase  as  much as  15.1  percent per acre per year, if an average 2.5
      applications of  malathion are used instead of lindane.  Costs would
      increase  2.5 percent  per  acre using oil (dormant).  And costs to
      growers  in  Mississippi and Louisiana would increase 0.1 percent per
      year usinc  endcsulfan.

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                     111-11.    Number of Pecan Trees,  Lindane-Treated Pecan Trees, and Amount
                                        of  Lindane  Used,  Selected States (Estimates for 1976)
1-1
M


Georgia
Missi ssippi
Ok Icihoiua
Texas
Other*
Total
( Avg . Percent ]
Pecan Trees
Bearing ••
Nonbea r i ng
1 ,000
1,359
255
532
1,549
U36
4,531


Iteari ng**
1 ,000
1,212
202
421
1,171
567
3,573

Li ndane-T
reated
bearing +
Nonbearing Bearing
1 ,000
40 .8
4U.4
42.6
232.4
83.6
447.8

1,000
36.4
30.4
33.7
175.6
56.7
340.8

Trees
Bearing +
Honbear ing
Percent
3
19
8
15
10
(11)

Lindane Usage (a.i.)
on Bearing and Non-
bearing Trees
1,000 Pounds
3.1
3.6
3.2
17.4
6.3
33.6

                 Alabama, Arkansas, and Louisiana.   J.indane  usage data were not provided by
                 Lliese states.  The Agency  assumes  that  bindane usage in these three states
                 was equal to the  weighted  average  of  treated bearing and nonbearing trees as
                 reported for the  states of Georgia, Mississippi, Oklahoma, and Texas.

                '  Pecan trees do not bear fruit  until  approximately 10 years of age.

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l-l
l-i
                  Table 111-12.
Treatment Costs of Various Insecticides  for  Control of Pecan
Phylloxera in the Southeastern U.S.  (Estimated for 1976)


1 nueutii ci de
I.i ndiine
Hal.athion
Gi 1. ( dot want )
lindotail tan

Label
Kate
Per Tree
0.075 pounds
0.67 pounds
0.7 tja lions
0.15 pounds
Price
per Unit
a . i .
Cost Per Tree Per Application

Material
Labor (.
Equipment

Total

15.00
4.36
3.30
6.00
1.13 0.55
2.92
2.31
o.yo
0.55
0.55
0.55
1.68
3.47
2.86
1.45
Applications
Per Season
Number
1
2.5
1
1
Seasonal Cost
Per Tree
Dollars
1.68
8.68
2.86
1.45

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                   Table  111-13.
                    Annual Treatment Cost  with  Lindane Compared to
                    Alternative Control Measures on Pecans,
                    Selected States, for  1976
n
1-1
1-1
I
lx>
CD
Annual
Slat c-
(Jeonj j a
M i uu i ssi ppi
Ok Icihoma
Texas
Ot.lier States*
Total
Treatment
1. i lulu Me

(>U.5
01. 3
71.6
390.4
MO. 4
752.2
Cost of Using Alternatives on
Malathion Oil

354.1 	
	 	
130.9 30.3
531.7
112.B 129.0
605.0 691.0
Endosul

9
70.2
	
	
16.1
86.3
Affected Trees
fan Total

354.1
70.2
169.2
531.7
257.9
1,383.1
Increase in
Compared to

285.6
(-11.1
97.6
141.3
117.5
630.9
Cost
Lindane


)



'Alabama, Arkansas, and Louisiana.   (See  Table  111-13.)

-------
alternative of choice, considering  that  it is lower in cost than iindane and
equally effective.  The  impact  of Iindane's  cancellation would be negligi-
ble if endosulfan were federally registered  or if other states granted
24(c)  registrations.  The Agency believes  it to be highly likely that
endosulfan will be used  as  a  substitute  for  Iindane in those areas where
Iindane is presently used on  pecars .

               The Agency also  has  developed a second scenario based on the
premise that endosulfan  would not become more widely available.  This
analysis was based on information provided by State entomologists working
from current registrations.   These  entomologists indicated that Iindane
would most likely be replaced with  endosulfan in Mississippi, with
malathion in Georgia, with  malathion  and oil in Oklahoma, and with oil in
Texas.  Under this scenario,  total  pest  control costs would increase for
these major states (and  three minor use  states) by approximately $63,000 if
Iindane were unavailable.   If malathion  is substituted for Iindane in
Georgia and Oklahoma, average yield losses of 25 percent to growers would
be anticipated.  The use of oil is  estimated to produce yield losses of 33
percent in Okalahoma, and 2.5 percent in Texas.—   Under this
scenario, the lost production to growers would be $742,000.  Overall loss
to growers from increased costs and yield  declines would be around $1.4
million.

     J.   Forestry

          1.   Usage

               Lindane is used  mainly on pines and conifers to control
several types of beetles (e.g.  Southern  pine beetle, turpentine beetle, and
mountain pine beetle).   While Iindane is presently not widely used, it is
the only pesticide which is effective in controlling insects in trees
already infested, and as such it  serves  as an option should other methods
fail.  Approximately  1,700  pounds of  Iindane were used in the U.S. for
forestry uses  (1975-1976 growing  season).   It is used primarily in the
South by the U.S. Forest Service  and  cooperating state agencies.

          2.   Alternate Methods  of Control

               Alternate chemicals  presently registered  include er.dcsuif an ,
ethylene dibrcraide,—  dicrotophos, and  chlcrpyrifos•  Additionally,
caccdylic acid, a herbicide,  is registered for killing trees, thereby
creating "trap" trees for  the beetles.——
      ,u            -                               .....
—    These  two  production  losses are not necessarily inconsistent  in
      that  the Texas  figures  are  an average based on treated trees  (which  is
      greater  than  infested trees)  while the Oklahoma estimate  is based  en
      an  average of  infested  tress.  In any case the economic impacts remain
      minor.

 17/   _„	
—    itnyiene oicrcraice  is uncer ."J?AJl review.
 13/	,        ,   .         .      	
—    rvr.en  ceetj.es  lay  tneir  eggs in cacccyiic  acia-treatea trees,
      larvae  are "tracoed"  because  the dead trees do not provide sufficient
      fcod  for their  survival.
                                111-29

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               Non-chemical control methods  are  already used in forests
to guard against infestation.  Methods used  are  basically good
silvicultural management (e.g. growing trees  on  favorable sites,  thinning
stands, preventing tree damage, and removing  weak  or  damaged trees)•
Additionally, practices designed to suppress  infestations (e.g. salvaging
infested trees, cut and leave, and cut and burn  procedures)  are prevalent.
Chlorpyrifos has been shown effective against southern pine  beetle and
other  forest pests (USDA Forest Service,  1979).   Non-chemical methods are
also effective suppression techniques in  all  but severe infestations.

          3.   Economic Impacts

               a.   Commercial Forests

                    If lindane were cancelled,  impac-s would be felt
primarily in the Southern  forests.  No impacts  are expected  in cooler
climates since insects are not active there,  and cultural, non-chemical
control of insect pests is practiced.

                    Among  southern  forests,  small  private land owners would
take the brunt of a cancellation, because this  group  relies  heavily on
chemical control and  cannot  generally afford labor-intensive cultural
management practices  prevalent on publicly owned or corporately owned land.

               a.   Seed Orchards and Gum Naval Stores

                    As a control method  which can effectively impede the
spread of  infestations, lindane  is  considered an important, control option
bv  seed orchard owners and by producers  of  naval stores, primarily because
their  individual trees are highly valuable  and the possibility of bark
beetle infestation is considered a  serious  economic threat.   It would
appear that  chlcrpyrifos is  at  least  as  effective as   lindane (U3DA Forest
Service,  1979).  There are approximately 10,000 acres of seed orchard in
the Southeast, the major area involved.   Orchard seed has been valued as
high as $1,000 per pound,  whereas  "wild"  seed gathered frcm  non-orchard
trees  is  valued  at about $35  to  $50 per  pound.   Gum naval stores producers
are also  located in the  Southeast.   In  1976,  producers in Georgia, Florida,
Mississippi,  and Alabama produced  crops  valued at $5.5 million.  Naval
stores production has declined  as  petroleum-based synthetics have been
developed.   Demand may  increase,  however, if petroleum becomes unreasonably
axoensive.

-------
                    Seed orchards are  generally  very well cared for, and
outbreaks of beetle infestation are relatively rare.   Lindane has not been
reported used in recent years on either  seed  orchard or  naval stores-
producing trees.   The value of lindane to both seed  orchard owners and
naval stores producers is as insurance against unpredictable and
potentially devastating beetle attacks.
                            19/
     X.   Livestock (Spray)—

          1.   Usage

               As a livestock spray, lindane  is  registered for controlling
numerous pests (e.g., fleas, flies, lice, mites,  and ticks) on livestock
(i.e., beef cattle, hogs and pigs,  sheep, goats,  and horses) and in
livestock premises (e.g., barns, pens, sleeping  quarters, and shelters).
Lindane use patterns have fluctuated frcm year to year,  but there has been
a distinct.decline between  1971,  (416,000 pounds)  and 1976 (176,000
pounds).—   This decline is shown  in  Table 111-14,  which lists USDA
estimates of lindane usage  on livestock  for 1964,  1966,  1971, and 1976.

          2.   Alternative  Methods  of  Control

               A total of 18 alternative chemicals to lindane .are
registered for the major livestock  class/pest combinations.—   Not
ail  alternatives apply to each livestock class/pest  combination, but there
are  more than ten alternatives for  each  combination, except for mites on
hoes  and pigs .   (Only three alternatives are  registered  for this applica-
tion, and one, methoxychlor, is registered  for use only  in combination with
toxaphene or malathion.)  The control  of mites in general—not only on hogs
and  pigs, but also en other classes of livestock—is problematic because of
a lack of efficacious alternatives  to  lindane.

               Table III-15 lists  estimates of alternative pesticides
versus lindane used on livestock  for  1964,  1966,  1971, and 1976.
 19/
—   Lindane  is  apparently very rarely used as a livestock dip,
     though it  is  registered  for dip as well as spray applications .

—   This  decline  is  frcm USDA estimates.   However, Hooker Chemical
     has reported  usage  for 1976 of 139,000 pounds, which supports the
     USDA  estimates.

—   The  18 alternatives are  Carbaryl (Sevin), Chlorpyrifcs
      (Dursban),  Couraaphos (Co-Ral), Crotoxyphcs (ciodrin), crufcmate
      (Ruelene),  Dioxathion (Delnav), Famphur (Warbex), Fenthion (tiguvon),
     Imidan/prolate,  malathicn, methoxychlcr (marlate) [registered only in
     combination with malathion or tcxaphene for rnite control on hogs],
     Phenothiazir.e, pyrethrins (synergized) , Rabon/Garcor.a, Rcr.r.ei
      (Korlan),  trichlorofon (Dylcx), Vapcna (DDV?)  and toxaphene (currently
     ur.der R?AR review) .

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               Tct I lie: 111-14.
Quantity of  Lindanu Used by U.S.  farmers on Livestock  in

1964,  1966,  1971,  and 1976 (USOA)
i-i
i-i
I
I.i vc stock
Class
Hucf Cattlii
lloijs ciiui 1J J ys
liuii.y Cuttlfc
Sllt:e[>
I'ou.I tr y
Other
•rota 1
1964
186
143
1'J
10
2
N/A
360
Use in 1 ,000-pounds Units
1966 1971
130
124
24
6
5
4
293
226
164
14
4
5
3
416
1976
79
91
3
2
*
1
176
               *  - Less tlian 500 pounds .

               tl/A — Data not available.

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                Table  111-15.   Quantity  of  Lindane Versus Alternative Pesticides Used  by  U.S.
                               fanners on Livestock in 1964,  1966, 1971, and 1976
Pestici de
I.i ndcine
Toxapliene
Muthoxyc-hlor
CotlMUlpllOt;
lu'xinel
Mai ii Lhj.cn
Dioxathion

1964
360
4,703
1,200
766
755
602
N/A
1,000
1966
293
3,670
1,509
434
391
735
43
Pound Units
1971
416
4,575
1,980
168
470
652
59

1976
176
2,376
2,360
517
403
1,104
100
1-1
I

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          3.    Economic Impacts

               For beef cattls, the annual cost of  lindane  treatment ranges
from SO.33 to §0.45 per animal; annual cost of alternative  treatments
ranges from 50.33 to $0.52 per animal.  For hogs  and  pigs,  the  annual cost
of lindane treatment ranges from $0.16 to $0.35 per animal;  annual cost of
alternative treatments ranges  from $0.18 to $0.49 per animal.   Should
lindane be cancelled for livestock applications,  pest control costs can be
expected to increase slightly.  Total' annual  increase in  the continental
U.S. is estimated at $1,033,400 ($233,500 for beef  cattle,  $349,800 for
hogs and pigs).  Because efficacious alternatives are available (except for
mite control) and because the  cost increase for alternatives is small (a
maximum of $0.03 per animal per year), no effect  on production  yield or
quality is expected, and no significant market impacts  are  anticipated,
unless mites become an endemic problem in a herd.   A  recent report by the
National Academy of Sciences recommends the use of  lindane  over any other
insecticide including the organophosphates because  control  can  be obtained
with only one application.  Other pesticides  are  not  as effective and
require multiple applications, which can lead to  development of genetically-
induced resistance  (Langford,  1980).

     L.   Existing  Structures  (Powderpost Beetles)

          1.   The  Nature of Powder Post Beetle Infestation

               Powder post beetles live inside wood.   Because of the slow
pace of their reproduction and spreading, significant powder post beetle
damage nay not occur until after  15-30 years  or more  of infestation
(Williams, 1979).   Sometimes  infestations of  powder post  beetles die
naturally, and not  all infestations cause economic  damage requiring
treatment.

          2.   Usage

               Lindane is used to  spot-treat  existing structures, mainly
houses, against  wood-boring powder-post beetles  (ancbiids,  lyctids, and
bostichids)  and  drywood  termites.  Though the amount  of lindane currently
used  to treat  existing structures  is  uncertain,  it  is believed  to be small
(less  than  1,000 pounds  on  10,000  or  12,000 houses).   Chicrdane has been
the chemical of  choice for  this application.  However,  this use of
chlordane  has  been  cancelled—though  existing stocks  can  still  be used
legally.   As a substitute for  chlordane,  lindane  has  a potantiai annual
market of  about  10,000 pounds  for  this purpose.

           3.   Alternative  Methods of Control

               As pointed out  by  several  state  extension  services, infesta-
tion  can  be  prevented, and  presumably retarded,  by  the use of painted or
otherwise,  finished vocd.   In  the  event  that  wood is  structurally damaged,
threat wood  can  be  replaced with  sound wood,  which  can be painted or
finished  to  zrevent future  infestations.

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               Several chemical  alternatives  to  lindane are, moreover,
registered for use on existing structures/  including  copper naphthanate,
methyl bromide, sulfuryl fluoride,  creosote,  creosote oil,  and pentachloro-
phenol (PC?).  PC? is the state  recommended alternative to  chlordane, which
was cancelled for this use.

          4.   Economic Impacts

               The economic  impact  of  cancelling the  structural use of
lindane is likely to be extremely slight.   Chemical  treatment can generally
be avoided by painting or otherwise finishing wood surfaces.  Should
chemical treatment be considered desirable, PC?  is available as an
effective and economically competitive  alternative to lindane.  The cost  of
the chemical used in a spot  spray treatment for  powder  post beetles is,
moreover, a small parr of the treatment cost,  and the total treatment cost
with either PC? or lindane is comparable  (5200-250) per hcrae).  For the
chemical cost, lindane is applied at a  rate of one gallon of 0.5 percent
solution at a cost of 0.48 per 500  square  feet,  and PC? is  applied at a
rate of one gallon of 5.0 per cent  solution at a cost of $5.95 per 500
square feet).  If PC? remains available,  no significant cost impacts to
pest control operators are predicted in the event that  the  use of lincane
as a spot spray treatment against powder  post beetles is cancelled.

               Finally, lindane  use is  basically limited to spot treatment
application.  In cases of very severe  infestation, fumigation is the
treatment method used.  Methyl bromide  and sulfuryl  fluoride are used as
fumigants and at the cost of 51,000-52,000 per home.

     M.   Hawaiian Pineapples

          1.   Usage

               Lindane is registered for  use  in  Hawaiian pineapple
production to help control symphylics,  root-f eedir.g  insects which attack
pineapple roots soon after planting.   Lindane is generally  used in
combination with soil fumigants  to  aid  in control of  symphylics.

               The Hawaiian  Pineapple  Growers' Association  estimates that
annual use of lindane on Hawaiian pineapples  ranges  from 18,000 to 48,000
pounds.  Other sources report to SPA that 19,300 pounds is  the estimate of
annual use of lindane on Hawaiian pineapple fields .   Hawaiian pineapple
production is based on a 3-  or 4-year  production cycle, which generally
includes two harvests and a  fallow  period of  2 to 12  months.  Approximately
13,400 acres are planted each year, and in 1977  total pineapple acreage was
43,000 acres (down from 58,000 acres in 1972).   Lindane is  applied, at the
beginning of the growing cycle,  to  approximately 9,550  acres each year,
which represents about 72 percent of annually planted acreage and about 22
percent of total pineapple acreage.
                                   111-35

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          2.   Alternative Methods  of  Control

               The following  soil  fumigants, which primarily control
nematodes, can give some assistance in controlling symphylids:
dibroracchloropropane  (DBCP),  ethyiene  dibrcmide (EDS),  Telone, and DD (a
mixture of 1^3 dichloropropene,  1,2 dichloropropane,  and related C-
compounds).—  • Ground preparation  is  important in assuring symphyiid
control since fumigants will  vaporise  off  the  soil in improperly prepared
or excessively, moist  soil.  Furaigants  do  not have residual action and offer
no protection against possible  late infestations.  Lindane is used
primarily as additional protection  to  compensate  for  adverse soil condi-
tions and late infestations.   Insufficient data on the  effectiveness of
lindane'and the probability of  late syraphylan  infestation, however, render
the true value of lindane difficult to confirm.  At present, there is no
non-chemical method of controlling  symphylids.

          3.   Economic Impacts

               Hawaiian Pineapple  Growers'  Association  officials have
estimated that if lindane were  unavailable as  an  anti-symphyiid treatment,
and growers were  thereby forced to  rely on the various  dual-purpose
fumigants, the result would be  an  annual  crop  loss of about 0.8 percent
(about  5150 tons  of the annual  crop),  valued at $515,000 at the farm level.
During  a  4-year production  cycle,  the  Hawaiian pineapple industry would
have  to absorb a  loss, at present  farm value,  of  $1,018,367.—
However,  no .firm  data are available to substantiate the estimate.  This
constitutes a minor impact  on the  pineapple industry.  No consumer impacts
are expected because  foreign  supplies  are presently available, and price
impacts from an annual crop  loss of 5,150 tons would be negligible.

      N.   Pets

          Lindane is  registered for control of ticks, fleas, lice, and
mites on  dogs , cats,  and their premises.   Registered products include anti-
flea  cat  collars,  dog wash,  dog shampoo,  and cog dust.

           1.   Usage

               Current data indicate that lindane  is not widely used on
pets  and  their premises.   About 30,000 pounds  are  used annually to treat
pets  for  parasite problems,  including scabies   (mange)-causing mites.  In
the concentrations  necessary  for parasite control, lindane  is tox^c to
cats, but not  to  dogs.   Only  Ohio  still recommends lindane  for control of
fleas on  cats .
 —   Chlorcpicrin is also registered as a dual-purpose soil  fumigant
      but it is not reported used.

 —   N'cne of this loss would be incurred the first year because  the
      first pineapple crop untreated with lindane would net be harvested  fc:
      20  .Tenths,  and growers would in fact save the estimated $33,000 spent
      each vear for lir.dane.  This annual savir.c has been  factored  into  the
      estimated total 4-year loss of $1,013,267.  Second-year Icsses vcuid
      be  3250,970, third-year losses 34-42,162, and fcurth-year Icsses
      34 12 , 225.

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          2•   Alternative Methods of Control

               There are  15 registered pesticide  alternatives to lindane
for control of insect pests on cats  and  dogs.   The  major alternates are
carbaryl, coumaphcs , pyrethrins, resmethrin  and ronnel.   However,  none of
these are reportedly effective against scabies-causing mites.

               Several preventive, non-chemical methods  also help control
parasites which attack pets.  Ticks  on dogs  can be  discouraged if grass and
weeds are kept mowed along paths and around  pet preraises .   Owners of dogs
and cats can control fleas by thoroughly vacuum-cleaning infested rooms,
Including carpets, rugs,  upholstered furniture, and other  items which may
harbor eggs or larvae.

          3.   Zconomic Impacts

               Lindane and its various alternatives are  generally in the
same price range.  Should lindane be unavailable  for use on pets,  any
economic impact would be  too small to measure,  and  this  holds for both
short-terra and long-terra  perspectives.

     0.   Household Uses

          Lindane  is registered  to control  the  following household pests:
ants , centipedes ,  clothes moths, house fleas, odorous house ants,
cockroaches, bedbugs, gnats, little  black ants, scwbugs, carpet beetles,
mosquitoes, scorpions, spiders,  waterbugs,  and  silverfish.   Under the
general category of household uses there are four major  applications of
lindane:

               (1)   Shelf Paper
               (2)   Floor Wax
               (3)   General Purpose Household  Spray
               (4)   Smoke-Fumigation Devices

          1.   Usage

               In  its various applications  as  a household pest control,
lindane is used by both commercial pest  control operators  and individual
homeowners.  Hooker Chemicals Company estimates that 31,971 pounds of
lindane are used  annually for household  purposes,(12,488 pounds for shelf
paper and 19,483  pounds for other  applications).—

          2.   Alternative Methods of Control

               There are  a number  of chemical  alternatives to lindane as a
household pesticide.  The most recommended  alternatives  include diazinon,
malathion,  naphthalene, paradichlorcbenzene, methoxychicr, and dichlcrvos.
—    USDA  estimated  33,788  pounds  cf lindane a.i. -used -annually for
      household  cur-cses.  An SPA survev cf pesticide use in households
      reported  no  use of  lindane.  S?A economists consider the Hooker
      estimate  to  be  the  best estimate available.

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          3.    Economic Impacts

               Because data on frequency of use and  relative  efficacy of
lindane and its alternatives are not available, comparative costs  of
application could not be calculated.  In general,  however,  effective,
ccmpetitively priced alternatives to lindane products  are  available.
Should use of lindane as a household pesticide be  cancelled,  no  economic
impacts are expected.

     P.   Minor Uses

          (1)  Moth Spray (Aerosol) - Industrial Use

          (2)  Uninhabited Buildings - Insect Spray

          (3)  Empty Storage 3in Fog Spray

          The Agency received no responses frcm registrants or  user groups
to its request for information concerning the benefits  of  those  minor uses
listed above or any of the other registered uses for  lindane.   The Agency's
review of the benefits of lir.dane uses also did not  report  any  data on the
benefits of these particular applications or the other  uses.   In the
absence of such information, the Agency must proceed  on the assumption that
the benefits Involved are negligible.
                                   111-33

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IV.  Development of Regulatory Options

     A.    Introduction

          In the previous Sections II and III, the human  and  environmental
risks associated with the uses of lincane were examined,  and  the  benefits
associated with each use were identified insofar as data  were available.
As explained in Section 1,  FIFRA mandates the Agency to achieve a balance
between the competing considerations of risks and benefits.   To carry  out
that mandate, the Agency has developed a range of regulatory  options and
proceeding on a use-by-use basis, has evaluated each option for its  impacts
on both sides of the risk/benefit equation.

          This section of Position Document 2/3 briefly summarizes the
salient risks and benefits associated with the uses of lindane and de-
scribes the process by which the Agency developed potential courses  of
action.  Section V proceeds with a use-by-use analysis of the risk/benefit
impacts of the regulatory options and explains the course'of  action  which
the Agency proposes to adopt and implement.

     3-   Salient Risk/Benefit Considerations

          In performing a risk/benefit analysis of the uses of lindane,  the
Agency identified several salient factors, on both sides  of the risk/bene-
fit equation, which became determining considerations in  the  development  of
regulatory options.  These considerations are reviewed below.

          1.   Salient Risk Factors
               As detailed In  Section  II,  two  of  the  original  risk criteria
cited in the RPAR notice as bases  for  the  Agency's  presumption against lin-
dane stand unrebutted and represent  significant chronic  human  risks:
(1) oncogenicity, and (2) reproductive/fetotoxic  effects.-  The studies
which showed that lindane is oncogenic  in  mice constitute  evidence that the
pesticide poses a cancer risk  to man.   Likewise the studies  which indicated
that lindane causes fetotoxic  effects  in test:  animals are  cause for concern
that lindane is fetotoxic to humans.   Because  no  lindane products are
currently registered for direct aquatic application,  the third presumption -
- acute hazards to wildlife, aquatic species — has been withdrawn.

               In addition to  the  risk  criteria upon  which the lindane R?AR
was based, the Agency identified as  areas  of concern  the following possible
adverse effects of the  pesticide and requested additional  information:  (1)
mutagenicity,  (2) blood dyscrasias,  (3) acute hazards to  humans and domes-
tic animals, and  (4) population reduction  in nontarget avian species •"
 \J   Although  fetotoxic  effects  are  considered a chronic risk,  it should
     be  pointed  out  that fetotoxicity can result from a single  exposure.

 2_/   The additional  issue  of  chemical isomerication effects of  lincane,
     also mentioned  in  the "JAR  notice,  is not a determining consideration
     for reasons civen  in  Subsection II.A.4.a of this zosition  document.
                                   IV-1

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               Concerning mutacenicity per se, the Agency has  en  the  basis
of available data determined that risk criteria warranting a rebuttable
presumption have not been met.  However, since indications of  mutagenesis
constitute indirect evidence of carcinogenicity, the positive  resoor.ses
observed in several studies lend qualitative reinforcement to  the Agency's
presumption of lindane's oncogenic effects.

               Regarding lindane-rsiated blood dyscrasias, the Agency has
likewise determined that risk criteria warranting a rebuttable presumption
have not been met.  Although insufficient evidence exists to firmly estab-
lish a cause-effect relationship between lindane exposure and  blood
dyscrasias, the Agency remains concerned, however, that the hematopoietic
tissues of certain individuals, particularly children, might be especially
sensitive to lindane.

               Regarding acute hazards as lindane-related adverse effects,
the Agency is, as a result of further SPA research, concerned  in  particular
aiout the acute effects of lindane on the central nervous system  (CMS),
especially with regard to children.- Studies have ccme the Agency's
attention which indicate that lindane bioaccumulates in the CMS,  triggering
symptoms of acute poisoning which are typical of CNS stimulation.  The
results of a recent study (Hanig et al., 1975)  indicate further that  young
animals (weanling rabbits) are more sensitive to the OJS effects  of lindane
than are adults, and these results take on added significance  in  light of
the recent fatal lindane poisoning of a child in Florida.  Given  this
evidence, the Agency concludes that as a CNS stimulant, lindane poses a
human risk and that this risk is particularly significant in cases of
exposure of children.

               Concerning population reduction  in nontarcet avian scecias
as a possible adverse effect of lindane, the Agency has determined that
risk criteria warranting a rebuttabls presumption 'nave not been met and
that there is little evidentiary basis  for concern.
 3/   Additional  Agency  findings  concerning  the  acute  effects  of lir.dane on
     the  central  nervous  svstem  are  addressed in  Subsection II.A.4.c.(4)•
                                    IV-2

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               The Agency's  concern  regarding the potential for lindane to
produce both acute and chronic  effects  in  humans  is heightened by the
persistence of lindane in  the environment.   As  residues of lindane can
remain in the environment  for a  long time  period, the potential duration of
lindane exposure following application  of  the chemical presents a
significant problem.  The  persistence of  lindane  poses a particular concern
for home uses, such as structures, household uses and pets, where residents
can experience substantial long-term exposure to  lindane residues.
Moreover, in general, there  is  concern  about the  bioacc-umulation of lindane
in humans and the burden this places on the  body's systems in view of the
widespread use of the compound  and its  mobility to sites far removed from
the treatment areas .

               The avenues of exposure  to  lindane are (1) dietary (oral),
(2) dermal, and (3) inhalational.  According to Agency calculations, a
likely dietary exposure to the  general  population via lindane residues on
food is 0.003 mg/kg per day.—    This represents a lifetime oncogenic
risk of 1.7 x 10   or roughly 17 potential  cancers per million people.

               Given established use patterns,  the subgroups subject to
dermal and inhalational exposure are pesticide  applicators, both profes-
sional and non-professional, and persons  who might be in the vicinity
during or immediately after  application.   Again,  special concern is war-
ranted in connection with  children,  who may  be  more sensitive to the toxic
effects of lindane than are  adults.   Workplaces and residences are the use
sites of main concern.

               Additionally, the Agency's  concern about the environmental
fate of lindane is further heightened by  the lack of information on
disposal methods for lumber  dipping  operations.  The Agency believes that
unless disposal methods preclude release  of  lindane into the environment
there exists a potential for indiscriminate  release of lindane whenever the
machinery and tanks are cleaned  of debris  which occurs normally during the
milling operations.
4/
—  Agency  calculations  of  dietary exposure to the general adult public
       are  civen  in  Subsection II.3.1.
                                   IV-3

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          2.   Salient Benefit Considerations

               The benefits of lindane  were  assessed in terms of economic
impacts which would result  if its  uses  were  cancelled and users thereby
forced to employ available  alternatives.   As  derailed in Section III,
should lindane be cancelled, the major  economic impact may be expected to
fall in the hardwood  logs and.1 lumber  industry.   Major impacts may occur in
production of hardwood and  ultimately consumer  gocds lumber, if
cancellation occurs and  if  alternatives do not  prove feasible.—
Possible major impacts would occur for  small  grains; however, at this time
the Agency does not have quantifiable data to  support these impacts.

               Moderate  impacts are anticipated in connection with
avocados, ornamentals and cucurbits.  These  moderate impacts on the local
producer would have no expected significant  impact on the nationwide
production of avocados and  cucurbits  or the  maintenance and production of
ornamental trees and  shrubs.

               For all other uses  of  lindane  minor to insignificant impacts
are projected to the  growers and producers.   The Agency does not expect any
measurable impact on  nationwide production or  prices of food, or any other
facet of the agricultural economy.

               The Agency anticipates that regulatory action short of
cancellation will have no significant impact  en the agricultural econcmy.

               In the course of the Agency's  benefit analysis, a general
lack of effective alternatives to  lindane  emerged as a notable issue of
concern.  No alternatives to lindane  are  currently available for use on
hardwood logs and lumber or in small  grain seed treatment. Certain target
pests of avocados, ornamentals, Christmas  trees, forestry, and pineapples
can be controlled by  substitute chemicals, but  no alternatives are
registered which control all the pests  of  concern.  For use on cue-orbits
and pecans, alternatives can be employed  with  varying levels of efficacy.
For scabies-causing mites en pets  and mites  on  livestock no completely
effective alternatives are  registered.

               The Agency's analysis  of benefits was hampered to a great
extent by inadequate  quantifiable  data.  3ata  limitations wera especially
problematic in connection with seed treatment,  the major use of lindar.e.
The Agency was unable to project potential yield losses  (except for corn)
and no quantitative estimate of the  economic  impacts of a seed treatment
cancellation could be mads.  Quantifiable  benefit data were unavailable
also in connection with  two lesser uses of lindane, forestry and Christmas
trees.  Again for these  two uses,  assessment  of benefits was limited
entirely to Qualitative  terms.
    wit.™  a  seed  treatment  cancellation,  cuar."
    available.
                                 IV-4

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     C«   Development of Regulatory Options

          With regard, to pesticide products  containing  lindane,  three basic
regulatory options have been developed  for consideration:

          1.   Continue registration without  restriction.
          2.   Continue registration but amend  the  terms  and conditions of
registration.
          3.   Cancel registration.

          Cancellation of registration  (Option  3) represents an  absolute
regulatory response, for it means that  the sale  or  the  distribution of the
pesticide for the use at issue is unqualifiedly  prohibited.   Unrestricted
registration (Option 1) likewise reflects an  absolute regulatory response
for it means that sale and distribution are  unconditionally continued.
Registration with amended terms and conditions  (Option  2),  however,
represents a range of possible courses  of action in that  the specific terms
and conditions of registration are formulated or modified by the Agency on
a use-by-use basis.

          The process of developing a full range of regulatory options by
which a statutory risk/benefit determination  with respect to pesticide
products containing lindane might be achieved focused on  means to reduce
levels of human exposure to the pesticide.   The  Agency  has  assessed the
various exposure situations at issue and has  developed  for  consideration a
number of specific measures by which exposure and risk  might be  reduced via
amendments to the terms and conditions  of registration.   The general and
use-specific measures discussed in the  following subsections have been
selected and reviewed based on both potential effectiveness  and  economic
and practical feasibility.

          Table IV-1 lists specific protective  measures taken into consider-
ation.  Table IV-2 shows the reduction  in total  body doses  anticipated in
connection with these measures.  Table  rv-3  shows estimated reductions in
risk.
                                 IV- 5

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                                  Table IV- 1.   List of Protective Measures Considered, Use by Use*
                         Use
                     1 lardwood 1 og
                      and lumber
                     Seed treatment
                     AvOCUdOS
    Items

Impermeable
protective
cloth 1 ng

Protect ive
clothiiuj,
Paper masks
 I
Oi
Protective
cloth Ing
and
Impermeable
ylovesj  or
Roof-type
shelters
                     Description

                -Elbow-length neoprene
                 ijloves, boots, and aprons
                -tony-sleeved work shirts,
                 long pants
                -Gloves to be vised during
                 mixing
                -Disposable paper masks to
                 be used during mixing

                -Long-sleeved work shirts,
                 long pants
                -Wide-brimmed hats
                -E Ibow- length
                 neoprene gloves
                -Or roof-type shelters on
                 machinery employed
      Affects on Exposure

-Dermal exposure to hands, arms,
 feet, and body avoided
-Respiratory exposure not altered

-Dermal exposure to arms, legs,
 and hands avoided
-Some reduction in dermal
 exposure to face
-Inhalation of dust particulates
 eliminated

-Reduction of dermal exposure
 to arms, legs, and hands
-Some reduction of dermal exposure
 to head, face, and neck area
-Respiratory exposure not altered
                     Ornamentcil a
                     1.  Homeowners
                     2.  CommercI a 1
                         App I ica tors
                     Cucurhi ts
Protective      -Long-sleeved work shirts,
Clothing,        long pants
Impermeable     -El bow-length neoprene
gloves           gloves

Protective      -Long-sleeved work shirts,
clothing,        long pants
Impermeable     -Elbow-length neoprene
gloves,          gloves
llespi rators     -Respirators
Protective      -Long-sleeved work shirts,
clothing         long pants
                                              -Reduction of dermal exposure
                                              to arms, hands,and legs
                                              -Respiratory exposure  not  altered
                                              -Reduction of dermal exposure  to
                                              arms, hand, legs, and hands
                                              -Reduction of dermal exposure  to
                                              face
                                              -Elimination of  respiratory
                                              exposure

                                              -Reduction of dermal exposure
                                              to arms and legs

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I-I
I
                            Table IV-1.   List of Protective Measures Considered,

                         Use               I terns            Description
                     f:l>r i stmas Trees   Protective
                                       cloth ing,
                                       Impermeable
                     Pecans
                     Forestry
                     Livestock
                -Long-sleeved work shirts,
                 long pants
                -Elbow-length neoprene
ylovea, boots,   gloves,  boots, and aprons
aprons
Protective
clothiny,
Impermeable
gloves;  or
Roof-type
shelters

Protective
cloth Ing,
Impermeable
gloves
-Long-sleeved work shirts,
 long pants
-Elbow-length gloves
-Wide brimmed hats
-Or roof type shelters
 on machinery employed

-Long-sleeved work shirts,
 long pants
-Elbow-length neoprene
 gloves
Protective      -Long-sleeved work shirts,
clothing,        long pants
Impermeable     -Elbow-length neoprene
gloves, boots,   gloves, aprons, and boots
aprons
                           Use by Use  (Cont.)

                                    Effects on Exposure

                             -Dermal exposure to hands,  arms,
                              feet, and body avoided
                             -Respiratory exposure  not
                              altered
-Reduction of dermal exposure to
 arms,  legs,  and hands
-Some reduction of dermal
 exposure to  head, face, and neck area
-Respiratory  exposure not
 altered

-Reduction of dermal exposure
 to face only
-Respiratory  exposure not altered
                              -Dermal exposure  to hands,  arms,
                              feet, and body avoided
                              -Respiratory exposure  not  altered
                     Structures

                     1 .  I nliub i iiants
                                       (lone
                                       
-------
                         Table  IV-1.   f.ist  of  Protective Measures Considered, Use by Use  (Cont.)
 I
U)
                 P i
                                        Items
              None Applicable
  Description

Hone Applicable
                 Pots

                 I .  Dog Washes
                         App'l. i-     Protective
                           Ccitors   clothing,
gloves and apron


None Applicable
                     b. Post
                        App] icat ion
I1 lea Collara, Hone Applicable
l)o
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                Table :iv-1.  List of Protective Measures Considered,  Use by Use  (Cont.)

   Uses                1 tenis             Description                 Effects on Exposure

Mi mil' Uses           None Considered     None  Considered                   None

1.  Motli Spray,
    1 iHlnstr i a I  Use

2.  Insect  Spray,
    lln i nhabj te<1  Uuildj ngs

Jl.  tinpty Storage 11 in
      l-'oij Spray

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T«il»l e  IV- 2.   Impact  of I'jcotoct Ivo  Htauutcq  on Tot Hi  liotly lk>tiuu Lo At*l*J lea tot* a
l):iti Dciuml Uptoko% Durmal my/kfj/Jay
ll.ii.»l 10% 0.0-iO

:;<:<:.!• T|-<;nlini!lit 1% O.O113
JWoiruilofi 1O% 0 . 66 /
(U iiiiuuM.t ula
Hoiiif'wiici-fj 10% O.O1
Coi.im. A|>|.l l<;ul "10 1O% 0.02-0.06

Cue, ill, till 10« O.O0014
<:lifliilm.in Lrucju 10% 0.009-0.269
I'ccim Oi cl^n. l,i 10% 0. IS
i-J Ki.runl.ry 10% O.O9
|'
,.„ l.lv/c-iil.ock 10» O.O02
O
SI", i iu:l lit 'Ml
A|i|. 1 1 cat OL'S 1(>% 1.35
(k:i:.i|..mrii

l'l.,.;.,,,,,l,:u
' l-olu
I'.:L 0,1 In, U
1 I-,') ll,».;l,
i A|.|.l !.:.,( ,,i 11 !()% O.OOO04
! I'ntM Ai'itl l<:>it li,il — —
llunplmloty imj/K
-------
. _,                     .
I-               ::|,i.iy
                  lltl|>l Oipk.l I 4-ll
                  n;.l.:i liil:i
                                                     Tallin  IV-2.    lm|>:u:t ti  of  I'jiol i:i:t I vu llc'.iiiili i::i  or  Tot.il!  lli_xly  Don.in  to  A|>|>1 IcallOCEl   (Coiil . )


                                                                                                                                                                     l^tf-l                           Annual  Total
                                                  ii'iin.il  ll|,i.ik.:\
                 l\|.|>lli:.it:il  A|>|vl I »:al I

               «III:)(:|H ttil il:i«::t
                 all.-. If  |.;iii.:i

                 floor  n.ix
Ivim.il nnj/kij/il.iy Hcnjili ul ory iny/kij/.liiy *
2.J x 10"' 7.2 x I.!, .,1,1 I .-.I
              llul l.lln<|:i                            -                               '   -                            O.OJ7                                     O.037                             0.4

              i:iii|>i.y .*:i «>i-.-it|u
              n I ii  Ki.i| :;|,i.ly                       -                                   _                            O.I 20                                     (1. 120                             1.5

              'HUH lli:!i|>l i .1(01 y  n|>lnko iiM>iiuin'toi M) ,  1-fusuiiL  Hue  I'tactlccii

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          1.   General (Non-Use~Specific) Measures

               The following measures have been  considered in  connection
with the broad spectrum of lindane uses.

               a.   Require Label Warnings for All Uses  of Lindane

               Under FIFRA, the Agency may require that  precautionary and
warning statements appear on pesticide labeling.  Given  the oncogenic,
acute toxic, and fetotoxic risks of  lindane,  and given the special
sensitivity of children to the toxic effects  of  the  pesticide,  the Agency
considers additional label warnings  to be a reasonable precautionary
measure.  Therefore, the following warnings are  proposed as label
precautions for pesticide products containing lindane.

                               Label Warning

The United States Environmental Protection Agency has determined that
lindane causes cancer and fetotoxic  effects in laboratory animals, and
central nervous system effects in both humans and laboratory animals.

Users:         Because lindane is highly toxic,  extreme  care should be
               exercised in handling this product.   [Use of this product
               is limited to certified applicators only.  Users are
               required to wear all  recommended  protective clothing.
               Protective clothing should be  laundered separately, and all
               users should shower thoroughly after  handling this product.
               Do not use .lindane products on pregnant or young
               animals.}—
Women:         Women of child-bearing age should not be  involved in the
               mixing, loading, or application of this product.  Exposure
               to lindane during pregnancy must  be avoided.

Parents:       Children are very sensitive to the toxic  effects of this
               pesticide.  Avoid use in areas where  children might be
               exposed.

               b.   Classify Lindane for Restricted  Use  and ?.ecuira
                    Applicator Certification. —'

                    Under ?!FR&, hazardous pesticides may be classified for
restricted use and limited to use only by certified  applicators.  This
measure would remove lindane from the open market and restrict its use  to
certified applicators and persons under their direct supervision.
Classified  for restricted use, lindane products  would be available only to
those users who have in fact undergone a certification program.  Such
programs are designed to encourage 'greater responsibility on the part of
applicators and thereby reduce exposure and adverse  effects, and ara
administered primarily by the states .
 6_/    Bracketed  matariai  would  be  included as  appropriate for those uses of
      lir.dane  for  which dedicator  certification  and protective clcthir.ci
      requirements  are  imposed  and/cr  those uses  which involve livestock cr
      pet  applications.

 ]_/    >
-------
                    All applicators would be required  to  obtain
certification.  If implemented this measure would have a  negligible  effect
on benefits.  All states currently have certification programs.   Non-
certified applicators would have to make minimal investments  in
certification courses.

          2.   Use-Specific Measures

               a.   Hardwood Logs and Lumber

                    Require that applicators wear impermeable (neoprene)
aprons, boots, and elbow—length gloves.

                    Three principal lindane treatment methods are used  in
the hardwood logs and lumber industry: 1) green chain dip vat, whereby
freshly sawed boards ara completely immersed prior  to stacking;  2) green
chain spray, wheraby the lumber is conveyed through a "spray  booth"
equipped with a low-pressure spray system; and 3) lumber  '"package dip vat,"
whereby packages of stacked lumber are immersed into a vat, then allowed to
drain.  These procedures take place in a covered but open plant.

                    As workers assist in guiding, pulling, and stacking the
lumber, they are subject primarily to dermal but also to  respiratory expo-
sure to lindane.  Exposure is estimated at 31,950 mg/yr  (dermal)  and 130 mg/
yr (respiratory).  At this level of exposure, cancer risks are estimated at
2.6 x 10 " and margins of safety at 11 (acute effects) and 22 (fato-
toxicity).

                    Measures short of cancellation  by which exposure and
risk to workers in the hardwood logs and lumber industry  might be reduced
were considered by the Agency based on their potential to reduce  levels of
dermal exposure, the primary source of risks to lumber plant  workers.
Because non-impermeable clothing could easily become saturated due to the
application methods' involved with this use, only impermeable  clothing could
measurably reduce dermal exposure.  The Agency has  determined that
requiring workers to wear elbow-length impermeable  (neoprsne)  gloves,
impermeable aprons, and impermeable boots would reduce dermal exposure  to
the hands, trunk, and legs, which are the crucial points  of contact.  The
estimated reduction in risks to be achieved via these  risk-reduction
measures are given in Table IV-3.  However, it should be  pointed out in
this connection that according to the OSDA, workers who handle treated
lumber are already provided with rubber gloves, aprons or rain suits, and
boots .  Subsequent inspection of some sites by 2?A  revealed that not all
workers wore this protective crear.

-------
                                Table  IV-3.-  Impacts of. Protectiv   tiasures  on  Applicator Risk
 I
i —
.1-
MARGIN OF
Risk
Reduction Fetotox i.c.i ty
Measures Before After
SAFETY
General Acute
Toxic i.ty
Before After
CANCER PROBABILITY
ESTIMATED
LIFETIME RISK

Before After
ESTIMATED
PERSONS
EXPOSED


              II.-
              llci rdwood   Tuipe nneable
              I.oijs  and   Protect! ve
              Lumber      Clothiiiy
              Seed
              Treat-
              ment
              ( tillla 11
              ijra i nu
              ami  corn)

              Avooados
I'1:0tecL i.ve
Cloth i IKJ ,
Paper Masks
Protective
Clothlny ,
y 1 o v e s ; or
Hoof- type
she 1. te i:u
                22
                                          28
 03
4-10
 31
                                                                        42
                                                                       220
 15
          2.6  x  10~2     6.9 x  10
                                                        Q.3 x  10
                                                                                          -5
                          5.0  x  10
                                                                                -6
        -4            -6
6.2 x  10        2 x 10
                                                                                              2400
                                    130,000
                                 275
Ornamentals

I. Home-    Protective
   owner    Cloth i n
-------
                   Table  IV-3.   Impacts  of Protective Measures on Applicator  Hisk (Cont.)


MARGIN OF SAFETY
Risk General Acute
Reduction Fetotoxicity Toxicity
e Measures Before After Before After
cans Protective 7 31 4 15
Clothing,
Impermeable
gloves; or
Roof- type
shelters
CANCER PROBABILITY
ESTIMATED
LIFETIME RISK

Before After
3. 1 x 10~4 7.5 x 10~5

ESTIMATED
PERSONS
EXPOSED


1200

Forestry   Protective
           Clothing,
           Impermeable
           Gloves

Livestock  Protective
           Clothing,
           Impermeable
           Gloves,  Boots,
           Aprona
              36
            42
 18
 21
1.9 x 10
                                                                          -3
5.5 x 10
                                                                                         -4
             416
         1,786
208
893
5.0 x 10
                                                           -6
1.3 x 10
Structures!
Hone
416
  'I iihab L ta 111:a App 1 icable

  Applicatora Protective
              Clothing
              Impermeable
              Glovea,
              Reapi rators
                        416
                          37
                4.6  x 10
                                                                          -4
                               18
               4.4  x 10
               U.8  x 10
                 -3
                 -3
                        4.6 x 10
                1.2  x  10
                2.5  x  10
                                                                                         -4
                                                                           -3
I'i ne-
app I o:j
Mono                                               .
Applicable 4.5 x 10  4.5  x  10   2.3  x 10    2.3 x 10
                                                      10
                                                       -12
                                      10
                                        -12
 1000
250,000
                                                                                    10,000 -  12,000
                                                                                       houses
                                               1600

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                     Table  1V-3.   Impacts of Protective  Measures on Applicator Risks  (Cont.)
Use
MARGIN Ob1
RJtik
Reduction l-'etotoxi ci t:y
Measures Before After
SAFETY
General Acute
To x i cl^ 	
Before After
CANCER PROBABILITY
ESTIMATED
LIFETIME RISK

Before After
ESTIMATED
PERSONS
EXPOSED


1 .  Do ij
   a. Appll- Protective    2.5 x 10   1.2 x 10    1.3 x  10    6.2 x 10
      ccitoi's Clothing,
             Impermeabl e
             Gloves and
             aprons
b. Pout   None
                           1.4x10   1.4x10   0.7x10    0.7x10
      cu Lion
2. Other
                                             2.4 x  10     4.8 x 10~8
                                             7.0 x  10~    7.0 x 10~
                                                           130,000
                                                           115,000,000
   c\ . !•' 1 ea     None
      Collars  Applicable
3 X 10
                                     3 X 10   1.4 X  10b   1.4  X 10       2 x 10 4    2  x  10~4
                                                           Not
                                                           Determined
   b. Do
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                 Table 1V-3.  Impacts of Protective Measures  on  Applicator Hicks (Cant.)





Use








lion
Use
1 .


2 .


3 .





4 .

CANCER PROBABILITY
ESTIMATED
MARGIN Of SAfETY LIFETIME RISK
Kisk General Acute
Reduction Fetotoxici_ty__^ ___2!Sii£iJtX__-_
Measures Before After Before After Before After
c . Doy Hone
Dusts Considered
-5 -5
1. Appli- 83,000 03,000 41,666 41,666 1.5 x 10 1.5 x 10
ca tors
-5 -5
2. Post- 9,260 9,260 4,630 4,630 1.9 x 10 1.9 x 10
application
sehol d
y
She if None _ _
-5 -5
Paper Considered 6,000 6,000 3,000 3,000 3.9 x 10 3.9 x 10
floor None
-4 -4
Wax Considered 1,250 1,250 625 625 6.7 x 10 6.7 x 10
General None _ _ _ _
7 7 7 7 -11 -11
Puipose Consi- 3.8 x 10 3.0 x 10 1.9 x 10 1.9 x 10 6.0 x 10 6.0 x10
Household dered
Spray
-3 -3
Smoke Hone 700 700 350 350 1.1 x 10 1.1 x 10
l-'umi licit ion Consi dered
ESTIMATED
PERSONS
EXPOSED



Hot
Determined








Hot

Determined
Hot

Determined


Not
Determined


Not
Determined
Duv j i:t;s

-------
Table '[V-3.  Impacts of Protective Measures on Applicator  Risks  (Cont.)
CANCER PROBABILITY
ESTIMATED
MARGIN OF SAFETY LIFETIME RISK
Klsk General Acute
Reduction Fetotox i cl ty Toxic i ty
(l:;<; Measures Before After Before After Before After
Minor Uaea
1. I'ndiiu- None Applicable
ti ial
U;;e Moth
Spray
a. Appli- 0 x 10'1 0 x 104 4 x 1Q4 4 x 10 1.3 x 10~ 1.3 x 10~
eatery
*~ J — ^ _ c.
7* b. I'oyt- 000 800 400 400 1.1x10 1.1 x 10
'~ rtppli-
0) ' l
Of.it ion
2. (In in- Hone
habited Applicable 135 135 60 60 1 .9 x 10~b 1.9 x 10~
Bui Id i ii'ja
1 nuect
Spray
.1. Empty Hone
Sl.ora.je Applicable 39 39 20 20 5.5 x 10~~4 5.5 x 10~4
Bin
ESTIMATED
PERSONS
EXPOSED








Not
Determined
Not
Determined
Not
Determined



Hot
Determined


-------
             b.   Seed Treatment

                    Require that applicators wear  long-_sleeved workshirts
and long pants, and cloves and disposable paper masks  during mixing.

                    In applying lindane products to  seeds,  applicators  are
exposed to airborne lindane dust particles generated during pouring  and
mixing of seed powder mixtures, whether by hand or mechanically.   Dermal
and respiratory exposure incurred by applicators are estimated at  306 mg/yr
and 7.8 ng/yr, respectively.  At this level of exposure,  cancer risks are
estimated at S.3 x 10   and margins of safety at 14  (acute  toxicity)  and
28 (fetotoxicity).

                    Measures short of cancellation by  which exposure and
risk to acolicators night be reduced were selected for consideration based
on their potential to reduce levels of dermal and  respiratory exposure.
Due to the method of preparing the lindane mixture for use,  inhalation  of
dust particulates could be eliminated by the use of  either  a respirator or
a paper mask.  Because respirators are not only expensive but impractical
for seed treatment application practices, paper masks  were  selected  for
consideration  in the Agency's risk-reduction calculations.   Crucial  points
of dermal exposure are the arms, legs, and hands of  the applicator.
Protective clothing requirements comprised of long-sleeved  shirts,  long
pants, and gloves would reduce dermal contact to these crucial areas.   The
paper mask would also reduce dermal exposure to the  face. •  The estimated
reduction in risks to be achieved via these risk-reduction  measures  are
given in Table IV-3.

               c.   Avocados and Pecans

                    1 )   Require that applicators  wear lor.c-sleeved  work
shirts, lone pants, wide-brimmed hats, and impermeable (neocrene)  albow-_
lencth gloves: or

                    2)   Require a roof-type shelter on machinery  being
employed.

                         Lindane is applied to pecan and avocado tress  via
a one-man air-blast or an air-delivery sprayer, once per year in pecans or
twice per year in avocados.  These procedures  subject  applicators  to dermal
and respiratory  exposure to  lindane estimated  at 304 mc/yr  and 1.2 mg/yr
respectively  for avocados and  3S6 mg/yr  and 0.6 mg/yr  for,pecans.   At this
level of  exposure cancer risks are estimated at 5.2  x  10   (avocados)  and
        — 4 ~
3.1 x  10  (pecans) and margins of safety at 4  (acute toxicity) and 7
(fetotoxicity).

                         Measures short  of cancellation by  which exposure
and risks to  applicators might be reduced were considered by the Agency
based en  their potential to  reduce levels of dermal  exposure, the  primary
source of applicator  hazard  for  these uses.  Due to  the spray application
                                    TV — 1

-------
methods involved, crucial points of dermal  exposure  are  the  hands,  arms,
and lacs of the applicator.  The Agency has determined that  requiring
applicators to wear long-sleeved work shirts,  long pants,  a  wide-brimmed
hat, and impermeable gloves would reduce  lindane contact with  the  crucial
points of exposure, and would also reduce dermal exposure  to the face,
head,  and neck areas.  The estimated reduction in risks  to be  achieved  via
these risk-reduction measures is given in Table IV-3.

               d.   Ornamentals

                    1)   Homeowner Use:  Require that homeowners wear
long-sleeved work shirts and long pants,  and  impermeable  (neoprene)  elbcw-
lengrh gloves.

                    2)   Commercial Use:  Require that applicators  wear
long-sleeved work shirts, long pants, impermeable (necprsne)  elbow-length
gloves, and respirators.

                         For ornamental use lindane  is applied as  a
dilution  (0.5 percent w/w lindane in solvent)  of a 20 percent  lindane
formulation via hand-held hydraulic or compressed-air sprayers.   Use
patterns for ornamentals vary greatly and the  range  of possible  exposure
varies with duration of spraying and the  number of applications  per  season.
These exposures range from 30 rag/yr( dermal  exposure) and  0.13  mg/yr
(respiratory exposure) for homeowners applying the chemical  to a few trees
once a year, to a range of 90 - 3,600 mg/yr (dermal  exposure)'  and 0.54  -
21.6 mg/yr  (respiratory exposure) for commercial nursery  workers applying
the chemical to a large number of trees over  a 15-day period.   This
exposure range results in an estimated cancer  risk to applicators  of
roughly 2.4 x 10  -2.9 x 10   and margins cf  safety  of roughly 94
(fetotoxicity) and 47 (acute toxicity) for  homeowners and  from 31  -  12
(fetotoxicity) and from 15-6 (acute toxicity)  for commercial applicators.

                         Measures short of  cancellation  by which exposure
and risks to applicators might be reduced were selected  for  consideration
based on their potential to reduce levels of  dermal  and  respiratory
exposure for this use.  Due to the application method involved,  crucial
points of dermal exposure are hands, arms,  and legs.  Lindane  is applied  to
ornamentals in the form of a spray, and   protective  clothing could
reduce dermal exposure to these areas.  The Agency has determined that
requiring commercial and homeowner applicators to wear long-sleeved  work
shirts, long pants, and elbow-length impermeable gloves  would  reduce
iindane contact with the crucial points of  dermal exposure.  Commercial
applicators would have the added requirement  of wearing  a  respirator, which
would eliminate respiratory exposure and  further reduce  dermal exposure by
protecting  the face.  Homeowner applicators would be exempt  frcm this
requirement due to the cost cf che article  and the short  duration cf their
exposure to lindane.  Table IV-3 snows the  es-imared reductions  in  risk
which would be achieved via these risk-reduction measures.

-------
               e.   Cucurbits

                    Require that ^applicators j*ear  lone-sleeved work
shirts and long pants.

                    For use on cucurbits  lindane is  applied with a row
crop boon sprayer.  This procedure subjects applicators  to both dismal and
respiratory exposure estimated at 0.42 mg/yr and 0.0126  mg/yr,  respective-
ly.  At this level of exposure, cancsr risks are estimated at 4.1  x 10
and margins of safety at 1,250 (acute toxicity) and  2,500  (fatotoxicity)•

                    Measures short of cancellation by  which exposure and
risk to applicators night be reduced were  considered by  the Agency based  on
their potential to reduce levels of dermal exposure, the primary source of
exposure and risk in connection with this  use.  Due  to the application
method involved, non-impermeable clothing  could reduce dermal exposure.
The Agency has determined that requiring  applicators to  wear long-sleeved
•*ork shirts and long pants would reduce dermal exposure  to the  arms and
legs, which are crucial points of exposure.  The estimated reduction in
risks to be achieved via these risk-reduction measures is  given in
Table IV-3.

               f.   Christmas Trees and Forestry

                    1)   Christmas Trees:	Require that  applicators wear
long-sleeved work shirts and long pants,  and impermeable (neopranej
aprons, _boots , and elbow-lenqrh cloves.

                    2)   Forestry•;_ Require that applicators wear  long-
sleeved work shirts and long pants, and impermeable  (neoprene)  elbow-
length gloves.

                         For use on Christmas  trees  and  in forestry lir.dane
is applied either by small back-pack sprayers or by  small  tractors pulling
mini sprayers.  These procedures subject  applicators to  dermal  exposure
estimated at 224 mg/yr  (forestry)and 28.3  - 1,008 mg/yr  (Christmas trees)
and respiratory exposure estimated at  18  mg/yr  (forestry)  and 0.216 - 36
mg/yr (Christmas trees].  At this level of exposure  cancer risks are
estimated at 1.9 x 10   (forestry) and 3.7 x 10 ~"  -  6.8  x  10
(Christmas trees).  Margins of safety are  estimated  at 18  (forestry) and
from 37-2 (Christmas  trees)  for acute toxicity and 36  (forestry) and
75-4 (Christmas trees) for fetotoxicity.

-------
                         Measures  short  of  cancellation by which exposure
and risk to applicators might  be reduced were  considered by the Agency
based on their potential to  reduce  levels of  dermal exposure, the primary
source of risks for these users.   Due  to the  applicator methods involved,
both r.cn-impermeable and impermeable  clothing  are necessary to rsduca
dermal exposure.  For use in forestry, crucial points of exposure are the
hands, arms, and legs.  To reduce  dermal exposure to these areas the Agency
has determined that applicators would  have  to  wear long-sleeved work
shirts, long pants, and elbow-length  impermeable  (neoprene) gloves.
Christinas tree use of lindane  poses added applicator exposure to the torso
and feet.  As a result the Agency  has  determined  that applicators would be
required to wear impermeable aprons and  boots  in  conjunction with the risk-
reduction measures stated above.   The  estimated reductions in risk to be
achieved via these risk-reduction  measures  for forestry and Christmas tree
use of lindane is given in Tabls IV-3 •

               g.   Livestock
                    Require  that  applicators  wear long-sleeved work
shirts and lone pants,and  impermeable  (neoprene)  aprons, boots, and
elbow-length gloves.

                    For  use  on  livestock lindane  is applied as an emulsion
via pressurised spray to  farm animals.   This  procedure subjects
applicators to exposure  estimated at  5.4 - 6.6  mg/yr (dermal exposure) and
0.06 mg/yr (respiratory  exposure).  At  this level of exposure, cancer risks
to applicators are  estimated at 5.0 x  10  , and margins of safety at 415
(fetotoxicity) and  208  (acute toxicity)•

                    Measures short  of  cancellation by which exposure and
risk to applicators might  be reduced  were considered by the Agency based on
their potential to  reduce  levels  of dermal exposure, the primary sources of
risks for this use.   Due  to  the application method involved, the wearing of
long-sleeved shirts and  long pants, and impermeable neoprene gloves,
aprons, and boots could  viably  reduce  dermal  exposure.  The Agency has
determined that requiring  applicators  .0 wear long-sleeved shirts, long
pants, impermeable  gloves,  aprons,  and  boots  would reduce dermal exposure
to the hands,  trunk,  and legs,  which  are the  crucial points of exposure.
The estimated  reduction  in risks  to be  achieved via these risk-reduction
measures  is given in  Table IV-3.   The  Agency  also is in the process
of evaluating  suitable  disposal or  recycling  requirements for the used
iincane product.  The Agency solicits  comments  in this area and will
address it mere scecificallv in ?D  4.
                     1)    Acoiicatcrs:   Recuire that acolioatcrs wear  lone-
 sleeved  work  shirts,  Icr.c cants ,  and impermeable (r.eocrene) elbow- ler.cth
 cloves.

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                    2)   Inhabitants:  Measures  shor~_ofcancellation not
practicable.

                         For use on structures iindane  (0.5 percent  w/w
lindane in water) is applied with a paint brush  for  small  areas  or applied
with a coarse spray for large areas.  These procedures  subject  applicators
to dermal and respiratory exposure estimated at  558  -  1,116 mg/yr and 13  -
36 mg/yr respectively.  Inhabitants are subjected to respiratory exposure
estimated at 60.48 mg/yr.  At this level of exposure cancer risks are
estimated at 4.4 x 10  - 3.8 x 10   (applicators) and  4.6  x 10
(inhabitants).  'Margins of safety are estimated  at 3  (applicators and
inhabitants)  for acute toxicity and 416 (.applicators)  and  5 (inhabitants)
for fetotoxicity.

                         Measures short of cancellation by which exposure
and risk to applicators might be reduced were selected for consideration
based on their viability as means to reduce levels of  dermal  and respira-
tory exposure.   Crucial points of dermal exposure for  applicators are the
arms, legs, and  hands.  Protective clothing requirements  comprised of
long-sleeved shirts, long pants, and impermeable (neoprene) elbow-length
gloves would reduce the dermal contact to these  crucial areas.   The
estimated reduction in risks to be achieved via  these  risk-reduction
measures are given in Table IV-3.

               i.   Pineaooies
                    For use on pineapples  lindane  is  applied by injection
via hoses from a supply tank regulated  by  pressure  valves  into the soil at
a depth of 3 to 78 inches  under  the  planting  line.   Applicator exposure to
lindane is possible only through inhalation of  vapors.   Dermal exposure
does not occur since the application procedure  prevents  applicator exposure
via splashing or mists>  Respiratory exposure to  lindane for applicators is
estimated at 5.6 }j 10   mg/yr.   At  this exposure  level  cancer risks are
estimated at 10  ".  Because current application  procedures  already
minimize exposure, no risk-reduction measures specific  to  this use were
considered ac-clica
                                       Recuirs  mat veterinarian
 applicators  wear  protective  clothing  and impermeable (neocrer.e)  apronjs and
 albov~1ancth cloves.

                          This  use  of  lindane  subjects applicators to dermal
 exposure  estimated  at  0.0312 mg/yr; respiratory exposure is negligible.  At
 this  level  of  exposure,  cancer  risk is  estimated at 2-4 x 10    and
 margins  of  safety  at  2.5  x 10   (fetotoxicity)  and 1.3 x 10" (acute
 effects).

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                         Protective measures by which  exposure  and risk to
veterinarian applicators might be reduced were selected  for  consideration
based on their viabilitv as means to reduce dermal  exposure.  Elbow-length
impermeable (neoorene) gloves and impermeable aprons worn  over  pror.act.ive
clothing would reduce dermal exposure to the hands,  forearms, and torso,
the crucial points of contact.  The reductions in risk anticipated via
these measures are given in Table IV-3.  For home applicators,  risk
reduction measures short of cancellation are deemed impracticable.

                    2)   ?lea Collar, Dog Dusts, and Doc Shampoo

                         Lindane flea collars, dog  dusts,  and cog shampoos
are used primarily in the home by private pet owners.  Risk-reduction
measures snort of cancellation are deemed impracticable.

               k.   Household Uses:  Shelf paper, floor  wax, general
purpose household spray, and smoke fumigation devices.

                    In connection with lindane household products,  risk-
reduction measures short of cancellation are deemed impracticable.

               1.   Minor iJses

                     In connection with the various minor  uses  of  lindane,
no submissions concerning benefits have been received, nor have Agency
efforts discovered any pertinent information.  In the  absence of  data to
the contrary, the Agency has necessarily assumed that  the  economic
benefits involved are negligible.  In view of the numerous,  diverse minor
uses at issue and the apparently negligible benefits involved,  the
development of use-specific risk-reduction measures short  of
cancellation is deemed imcracticable.

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V.    Proposed Regulatory Decision

      As  stated in  Subsection IV.C,  the Agency has developed three basic
regulatory  options to  be considered with respect to pesticide products
containing  lindane:

      1.   Continue registration without restriction.

      2.   Cancel  registration unless the terras and conditions of
registration  are  amended.

      3.   Cancel  registration.

          Subsection V.A below proceeds with a use-by-use analysis of the
risk/benefit  impacts of  the  regulatory options.   Subsection V.3 summarizes
the  course  of action which the Agency proposes to adopt and implement.

      A.   Risk/Benefit Analysis of  Regulatory Options,  Use-by-Use

          1.    Hardwood  Logs and Lumber

                If  registrations of  lindane products for use in the
hardwood  logs and  lumber industry were continued without restriction
(Option  1), an estimated 2/400  applicators would continue to be exposed to
lindane via. dip or spray treatments.,, Cancer risks to these applicators
would remain  at an estimated 2.6x10 ~, and margins of safety would remain
approximately 11  (acute  toxicity) and 22 (fetotoxicity).  Under Option 1
•the  benefits  associated  with this use, estimated at $147 million, would
likewise  continue  unaffected.

                If  registrations of  lindane for use in the hardwood logs and
lumber  industry wars continued with amended terms and conditions (Option
2),  the  following  provisions would  apply.  All pesticide prcducts containing
lindane would be  classified  for restricted use,  and applicator certification
would be  required. The  warnings to users, to women, and to parents
specified in  Subsection  IV.C.I.a would be  required to appear on the labels
of  all  lindane products.  Applicators would be required to wear impermeable
protective  clothing  (elbow-length neoprene cloves, neoprsne aprons, and
necprene  boots),   (Refer to  Table IV-1.)  Via these risk-reductioc
measures, cancer  risks could be reduced from an  estimated 2.6x10 ~ to
5.9x10    and  margins of  safety increased from 11 to 42  (acute toxicity)
and  frcm  22 to S3  (fetotoxicity) .  (Refer  to Table IV-3.)  The provisions
of Option 2 are expected to  have a  minimal impact on economic benefits.

                If  registrations of  lindans oroducts for use In the hardwood
logs and  lumber industry were cancelled (Option  2], ail iindane-related
risks to  actlicators would be eliminated.   The economic impacts whicn wouid
result  frcm cancellation of  this use are estimated at $147 million.
Presently,  r.o alternative  chemicals ara registered.

                Having  evaluated the cancer, acute toxic, and fetctoxic
risks cosed to acnlicators lr. conjunction  with lindane  use in the hardwccc.

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logs and lumber industry,  the Agency has  determined than continued,
unrestricted registration  (Option  1) is unjustifiable.   Option 2 would be
acceptable in this instance only if the reduced  risks  thereby achieved
were decidedly outweighed  by benefits.  Given  the  substantial risks which
would remain even if specified  risk-reduction  measures  were implemented
(Table IV-3), the Agency's determination  is  that Option 2 would fail to
reduce risks to a level which would be outweighed  by benefits and that
cancellation (Option 3) is warranted.

               While the prospective long-term risks outweigh benefits ever
when the provisions of Option 2 are taken  into account,  the following
considerations lead the Agency  to  recommend  cancellation to take effect
after a chase-out/interim  period.  As discussed  in Subsection III.C.2., no
alternative chemicals are  registered to control  ambrosia beetles or
flat-headed and roundheaded borers , which  are the pests  of main economic
importance to the industry.  Nor ars non-chemical  methods available which
can viably control the target pests.  Due  to this  lack  of alternatives,
economic impacts estimated at $147 million are expected to fall to the
hardwood logs and lumber industry, which  is  characterized by a large numbei
of small, family-owned mills.   Impacts are expected to  fall primarily  to
southern mills because that is  where the  insect  problem is -.ost prevalent.
The possibility of mill closings is thereby  raised.—

          To encourage technological development of a  suitable aiterna-
tive(s) fcr'use in the hardwood logs and  lumber  industry,  and thereby  to
moderate the major economic impacts expected to  result  from an immediate
cancellation, the Agency proposes  cancellation to  take  effect after two
years, during which time ail of the amended  terms  and  conditions cf
registration specified under Option 2 would  apply.   This time frame
reflects the Agency's best judgment regarding  the  time  period necessary to
register an appropriate alternative.  The  Agency has received some
information that chlorpyrifos is a pesticide whose biological activity is
similar to lindane's and will provide adequate control  for insect pests
found in hardwood logs and lumber.  Chlorpyrifos has been registered for
use on live trees in forests and would therefore be expected to control
target pests in felled trees and cut lumber.

               ?I?SA and related regulations require the Agency ~o consida:
both the risks and the benefits associated with  the uses of pesticides.
The proposed decision to cancel this use  of  lindane after two years, and
in the interim to amend the terms  and conditions of registration,  repre-
sents the Agency's best determination, taking  into account the risks and
the benefits associated with iir.dane use  in  the  hardwood legs and lumber
industry.  As discussed above,  the major  economic  impacts expected in
connection with an immediate cancellation  can  therabv  be averted.   Because
exposure to a-oolicators would be reduced  from  an estimated 40 vears

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 (estimated  lifetime exposure)  to 2  years, cancer risk to applicators
 wearing  jjmpermeable protective clothing would be reduced from 6.9 :< 10
 to  3.9 x  10   .   Because during the 2-year phase-out/interim period,
 applicators would be required  to wear the impermeable protective clothing
 specified  under  Option 2,  margins of safety would be increased from roughly
 11  to 42  (acute  toxicity)  and  from 22 to 33 (fetotoxicity).

               To recapitulate, the Agency proposes that lindane use  in  the
 hardwood logs  and lumber industry be cancelled to take effect after two
 years in order to allow for the development/registration of a suitable
•alternative(s).   During this 2-year phase-out/intsrim period, all of  the
 amended  terms  and conditions of registration specified under Option 2 will
 apply.

           2.   Seed Treatments

               If registrations of  lindane products for use as a seed
 treatment  were continued without restriction (Option 1), an estimated
 130,000  aoolicators would continue  to be excosed to lindane.. Cancer  risks
          —                                 "               —3
 to  these applicators  would remain  at an estimated 3.3 X 10   , and
 margins  of  safety would remain approximately 14 (acute toxicity)  and  23
 (fetotoxicity}.   However,  these calculations apply only to adults.  Minors
 are commonly  involved in seed  treatment application practices.  Because
 children are  believed to be more susceptible to the toxic effects of
 lindane  than  are adults, the MOS for children in connection with acute
 effects  is  likely to be considerably lower.  Under Option 1, the
 unquantifiable econcmic benefits associated with iindane use as a seed
 treatment  would  likewise continue unaffacted.

               If registrations of  lindane for use as a seed treatment were
 continued  with amended terms and conditions (Option 2), the following
 provisions  would apply.  All pesticide products containing lindane would be
 classified  for restricted use, and  applicator certification would be
 required.   The warnings to users, to women, and to parents specified  in
 Subsection  IV.C.I.a would be required to appear on the labels of ail  lindane
 products.   Applicators would be required to wear protective clothing  (long-
 sleeved  shirts,  long pants, gloves, and disposable paper masks).   (Refer to
 Table IV-1.)  Via these risk-reduction measures, cancer risks could be
                                   — D            —O
 reduced  from  an  estimated 3.3  X 10    to 5.0 X 10  , and margins of
 safety  increased from 14 to 220 (acute toxicity) and from 23 to 440
 ( fetotoxicity) .   (P.efer to Table IV-3 . )   The provisions of Option 2  are
 expected to have a minimal impact on econcmic benefits.

               The Acencv's evaluation of the imcacts of cancellation
 (Option  3)  of  lindane seed treatment has bssn hampered by the lack of
 benefits information submitted by the U.S. Department of Agriculture  and
 other- interested groups.  Mevertheless, certain conclusions can be drawn.
 For com acreage, ciazinon is  an inexpensive alternative that is effective
 against  most  com pests, and henca  adverse economic impacts in corn are  not
 extected to occur.  For small  crains and other crocs, the benefits
 situation is  more crobiematical; civen the lack of aitarnatives.   On
 account  of the lack of biological inf orrr.ation, the Agency has been unable

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to predict with any confidence  the  likelihood of ir.fastation or  the  loss
from given levels cf infestation, assuming no pesticide treatment.   The
Agency dees believe, however,  that  based  on the way in which lindar.e  works
to protect: th.e ur.sprouted seed,  it  is  basically an insurance treat.-7.enu and,
as such, is unlikely to be  effective  where heavy infestation occurs.  Hence
the risks posed by corn seed  treatment strongly outweigh the small benefits
for' that crop.

               For the remaining seed  treatment uses, the regulatory
decision is a difficult one.   After careful consideration the Agency  has
concluded that the risks cf use on  these  crops even reduced by protective
measures outweigh the benefits  of use  insofar as the benefits are presently
known and therefore recoiriEier.es  cancellation.  The Agency invites  the  agri-
cultural community and other  interested groups during the comment period  to
focus particular attention  on the benefits of lindane seed treatment  en
small grains, dry peas and  lentils  and the potential of developing alterna-
tives.  The Agency will reevaluate  its proposed decision in light of  the
comments received.

               Having evaluated the cancer, fetotoxic, and acute  toxic
risks posed to applicators  as well  as  the dietary cancer risk to  the
general public in conjunction with  lindane use as a seed treatment,  the
Agency has determined that  continued,  unrestricted registration  (Option  1)
is unjustifiable.  Option 2,  which  would continue registrations  with
amended terms and conditions, would be acceptable in this instance only  if
the reduced risks thereby achieved  were decidedly outweighed by  benefits.
Given the ur.quantif iabie benefits associated with this use, however,  and
given the substantial risks,  including a dietary cancer risk (Table  II-5),
which would remain even if  specified risk-reduction measures were
implemented,  an Agency determination that the benefits associated with
lindane seed  treatment are  of sufficient macnitude as to outweich risks
   .,,_,..,        ,   .    ..."•/   ,"        ,     .    .  '
wouid be r-icnlv ssecu.La-.ive in casis,—   The Acer.cv r.as tnererore
2/
—   Data  in  tne  Agency's  possession indicate tnat r.eitner  ciazincr.  nor
    chiorpyrifos  poses  unreasonable adverse effects.

-   .-.egistraticr.s of  heptachlor are being phased cut en  the  basis cf
    carcincgenicity.

—   The  Agency points cut that the burden cf prcof  with  respect  to  the
    benefits of  a pesticide as used for its intended purpose  lies with  the
    registrants.   A general lack of data concerning  the  frequency of  wire-
    worm infestation  and  ccmoarati'.'e data ccncernir.c the  extent  cf  crco
    damace  and vieid  loss attributable to the tarcat tests,  with and  withcui
    lindane  seed treatment, contributed to the trctcsed  cancellation.   Any

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determined that Option  2  is  unacceptable  and that cancellation (Option 3)
is warranted.  The Agency recommends  than Option 3 be implemented with the
call for additional  information  and  cancellation of registrations of
lindane products for use  as  a  seed treatment is  hereby proposed.

          3.   Avocados

               If registrations  of lindane products for use on Florida
avocados were continued without  restriction (Option 1), an estimated 275
applicators would continue to  be exposed  to lindane via high-exposure spray
treatments.  Cancer  risks to these aoolicators would remain at an estimated
        —4                           —
6.2 X 10  , and margins of safety would remain very low:   approximately 4
(acute tcxicity) and 7  (fetotoxicity).  Under Option 1, the economic
benefits, estimated  at S3.7  million  associated with lindane use on Florida
avocados would likewise continue unaffected.

               If registrations  of lindane for use on avocados were
continued with amended terms and conditions (Option 2), the following
provisions would apply.   All pesticide products  containing lindane would be
classified for restricted use, and applicator certification would be
required.  The warnings to users, to women,  and  to parents specified in
Subsection IV.C.I.a would be required to  appear  on the labels of  all
lindane products.  Applicators would be required either to wear protective
clothing (long-sleeved shirts, long  pants,  and wide-brimmed hats) and
impermeable gloves or to  employ  a roof-type shelter on machinery  being
used. (Refer to Table IV-1 . ) Given the climate conditions of Florida,
however, whether protective  clothing would in fact be worn is admittedly
cruestionable.  Via these  risk-reduction .measures ,  cancer  risks could
                                      —4           —o
theoretically be reduced  frcm  6.2 X  10    to 2 X  10  ,  and margins of
safety increased frcm 4 to 15  (acute toxicity) and from 7 to 31
(fetotoxicity). (Refer  to Table  IV-3.)  The provisions of Option  2 are
expected to have a minimal impact en economic benefits.

               If registrations  of lindane products for use on avocados
wers cancelled (Option 3), all lindane-related risks co applicators as well
as a cancer dietary risk  would be eliminated.  The economic impacts which
would result frcm cancellation of this use  ara estimated,  based on the
projections of local experts,  at 53.7 million and  would be experienced by
Florida growers,—  assuming  no change in  grading standards.  Although
no chemical alternatives  are currently registered  for  mirid control,
several premising alternatives (such as acephate)  are  undergoing  testing.
Preliminary indications suggest  that these  chemicals may  prove efficacious
for mirid control.  Parathicn, presently  used only in California, is
available for control of  webbincrworrs .  Anticicatad losses
5/        As noted in Subsection III.S.3,  this  estimate  rslias heavily u~or.
          information provided by persons  with  expertise  in  Florida  avocado
          production and assumes that  their projections  of  crop loss are
          accurata.  No data are available concsrninc  tha  extent of  viald
          loss attributable to mirids, with and  wi-hcut  iindane spray

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are strictly from lack of mirid control.  Because California  produces
almost 80 percent of the nation's avocados,—7  no  impact  on  -he
availability of avocados nationwide  is  expected,  and  should the gracing
standard for avocados be amended there  could  be no  significant impact
resulting from cancellation.

               Having evaluated the  cancer, fetotoxic,  and  acute toxic
risks posed to applicators in conjuncticn with lindane  use  en avccadcs,
the Agency has determined, chat these risks are unacceptably high and that
continued, unrestricted registration (Option  1) is  unjustifiable.   Option 2,
which would continue registrations with  amended terns and conditions, would
be acceptable in this instance only  if  the reduced  risks thereby achieved
were decidedly outweighed by benefits.   Given  the high  level  of exposure
associated with this use of iindane, however,  substantial risks would
remain even if the specific provisions  of Option  2  were  implemented.  Also
these low margins of safety and high cancer probability  are not offset by
firmly substantiated benefits attributable to  iindar.e as an anti-mirid
pesticide.—   The Agency has therefore  determined that Option 2 is
unacceptbie and that cancellation  (Option 3}  is warranted.   Option 3 is
hereby recommended, and cancellation of  registrations of lindane products
for use on avocados is proposed.

          4.   Ornamentals

               If registrations of lindane products for  use on ornamentals
were continued without restrictions  (Option  1 ) , an  estimated 30-1,200
professional applicators and an estimated 75,000  homeowner/applicators
would continue to be exposed to iindane via spray treatments   to control
corers, thrips, and iaafmir.ers on a  variety of floral and foliage plants
and woody ornamentals.. Cancer risks to these  aooiicatcrs would remain at
       . "            ~3                        " " -3            - j
an estimated 2.4 X  10    (homeowners) and 7.3  X 10    to  2.9  X 10
(commercial users), and margins of safety  would  remain  approximately 47
for homeowners ar.d 5-16  for commercial  users  (acute toxicity) and 94 for
homeowners and 12-31 for commercial  users  (fetotcxicity).  However, these
calculations apply only  to adults.   .Margins of safety for acuta effects in
children  involved in application processes are likely to be considerably
lower.  Under Option 1,  the aconcmic benefits  associated with lindane use
on ornamentals, roughly  estimated  at $20.e million  fcr  commercial growers
of ornamentals, would  likewise continue unaffacted.
           Pesticide  use  by  California  avocado  growers  is very limited, and
           California has  not  reported  using iincar.e in avocado groves.

           The Agency is  aware that  the Agricultural Research and Education
           Center  of  the  University  of  Florida  is currantly conducting
           pesticide  field trials  on the avccado/mirid/lir.dane issue.   The
           experiments ire scheduled for completion in  
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               If registrations  of  lindane  for  use on ornamentals were
continued with amended terras  and conditions (Option 2),  the following
provisions would, apply.  For  commercial  use,  all  pesticide products
containing lindane would be classified for  restricted use,  and applicator
certification would be required.  The warnings  to users,  to worsen, and to
parents specified in Subsection  IV.C.I.a would  be required to appear on
the labels of all lindane products.  Commercial applicators would be
required to wear protective clothing, impermeable gloves,  and a respirator.
Via these risk-reduction measures cancer risks  for commercial applicators
could be reduced from an estimated  7.3 X 10   - 2.9 X 10    to -4.1 X 10
 -3.8 X 10   and margins of safety  could he  increased from. 5-16 to 41-
125 (acute toxicity) and from 12-31 to 8-3-25  (f atotoxicity) .   (Refer to
•Table IV-3 . )

               For home use,  homeowner/applicators would be required to
wear protective clothing (long-sleeved shirts and long pants) and elbcw-
length impermeable gloves.  Via  these risk-reduction measures cancer risks
to homeowner/applicators could be reduced frcra  an estimated 2.4 x 10   to
5.0 x 10   and margins of safety could be increased from 47  to 132 (acute
toxicity)  and 94 to 335 (fetotoxicity).  (Kefar to Table  IV-3.)  The
provisions of Option 2 are expected to have a minimal impact on economic
benefits.

               If registrations  of  lindane  products for  use on ornament: a is
were cancelled (Option 3),  all lindane-related  risks to  applicators would
be eliminated.  The economic  impacts which  would  result  from cancellation
of this use are estimated at  520.6  million  to commercial  growers of
ornamentals.  Impacts to homeowners would be  largely aesthetic and such
are not cuantifiable.  In areas  where borer  infestations  are  oarticularly
oroblamatic, homeowners misht be  forced  to  abandon cajrtain soecies of wccdv
                                                    'd /
ornamentals or to employ professional pest  control.""   Presently,
lindane is the only pesticide registered t:o  control ail  borers on woody
ornamentals.  Although alternative  pesticides are generally available for
pest control on floral and foliage  plants,  only two alternative pesticides,
chiorpyrifos and andosulfan,  are  registered for borer control on woody
ornamentals. —   However, these  two alternative pesticides ara effective
on.lv on selected soecies of ornamentals.
 —    The cos- of professional  treatment  would  range  from roughly 320.00
        to 555.00 per treatment per  yard  (Memo  13303.

9 /
 —    Data available to the Agencv indj_cazs  that  neither  cr.lcr'ovri.rcs r.cr
        endos'ilfan coses unreasonable  adverse effects.

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               Because the risks and benefits  associated with lindane 'use
by commercial growers of ornamentals differ  from  those  associated with
homeowner use, tha Agency has necessarily considered  these  two applications
separately.  Regarding commercial applications, the Agency  has evaluated
the cancer, fetotoxic, and acute toxic risks posed  to applicators and has
determined that under current use patterns,  risks decidedly outweigh
benefits.  Continued, unrestricted registration has therefore been found
unjustifiable.  At the opposite end of the regulatory spectrum,
cancellation (Option 3! would eliminate all  lindane-related risks to the
professional applicators involved.  In view  of the  economic impacts
(estimated at 20.5 million) expected to fall to commercial  growers of
ornamentals as a result of a lindane cancellation,  however, and in view of
the substantial reductions in risk which can be achieved by measures short
of cancellation (Table IV-3), the Agency has concluded that Option 3 does
not represent an appropriate risk/benefit determination in  this  instance.
Ooticn 2 is therefore recommended.  The Agency herebv orcposes that
registrations of lindane products for use on commercial ornamentals ba
continued with the amended terms and conditions specified.

               Regarding home applications,  the Agency has  evaluated the
multiple risks posed to homeowner/applicators  and has again determined that
under current use patterns, benefits are clearly  outweighed by risks arid
that Option 1 (continued, unrestricted registration)  is therefore
unjustifiable.  Although if rigorously implemented, the provisions of
Option 2 (continued registration with amended  terms and conditions) would
measurably reduce risks to homeowner/applicators, Option 2  would not reduce
risks to a level which would ensure no adverse effects  to the large number
of persons involved.  It is Questionable, moreover, whether the  orotactive
clothing requirements of this option are practicable  in connection with
homeowners.  In view of the risks which would  continue  to be posed to
homeowner/applicators even when the risk-reduction  provisions of Option 2
are taken into account, and in view of the largely  aesthetic benefits
involved, the Agency has determined that Option 2 fails to  reduce risks to
a level which is outweighed by benefits.  Option  3  (cancellation) is
therefore reccmmendac.  The Agency hereby proposes  that registrations of
iindane oroducts intended for home ornamental  use be  cancelled.   —
 10 /
  —   The Agency's risk/benefit  determination  concerning  homeowr.er use of
         lindane on ornamentals was  based  on  the  application of  lindane as a
         spray  (typical  rormuiatJion:   0.^  percent  w/w ..means soiutr.cn) .
         Tha Agency is aware  of a 2-peroent paste  formulation -hat is also
         registered for  use on ornamentals.   However,  the  Acencv has r.o data
         certaininc to usace, aooiicator  exposure,  or benefits uccn which to
         evaluate  this croduct.   Anv additional  information  on this
         formulation  submitted  io the Agency  will  be  taken into  account in
         the final decision to be issued  in Position  document 4.

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          5.    Curcurbits

               If registrations of lindane products  for  use  on  cucurbits
were continued without restrictions  (Option  1), an estimated 950
applicators would continue to be exposed to  iindane  via  treatments  with row
cron boom soravers aoolvina a 0.06 w/w  (Iindane weicht to  water)  sorav_.
   - _      -  ^ -      - - -   -                        -              -   =.0
ror tr.ese applicators, estimated car.car risk would remain  at 4.1  X  10
and margins of safety would remain approximately 2500  (fetotoxicity)  and
12SO (acute toxicity). Under Option  1,  the benefits  associated  with  lindens
use on cucurbits would regain unaffected.  The economic  benefits  associated
with this use axe estimated at 2.4 million collars for Florida, South
Carolina, arid Georgia. —

               If registrations of Iindane products  for  use  on  cucurbits
were continued with amended terns and conditions (Option 2),  the  following
provisions would apply.  All pesticide  products containing Iindane  would be
recuired to disolav the label warnings  specified in  Subsection  IV.  C.1.a.
Lindane products would be classified for restricted  use,  and applicator
certification would be recuired.  Acolicators would  be required to  wear
protective clothing (long-sleeved work  shirts and long pants).   (Refer  to
Table IV-1.)

               Implementation of these  risk-reduction  measures  would reduce
car.csr risks from 4.1 X 10   to 4.0  X  10   and increase  estimated
margins of safety from 2500 to 25,000  (fetotoxicity)  and from 1250  to
12-,500 (acute effects).  (Refer to Table IV-2 . )  The provisions of  this
oction are expected to entail no significant imoact  on economic cenerits<

               If registration of Iindane products for use on cucurbits
were cancelled (Cctior. 3), all risks associated with Iindane would  ce
eliminated.  For the  reasons discussed  in Chapter III, cancellation of
Iindane would not result in significantly decreased  yields.   Furthermore,
the minor impacts projected for increased treatment  costs of alternatives,
$175,000, may be high  insofar as it  assumes  that the growers in certain
areas will switch to methcmvi which  is  bv far  the most extensive
alternative.

               The Agency has evaluated the  cancer,  fetotcxic,  and  acute
toxic risks posed to  applicators in  conjunction with Iindane use  on

(Option 1) is unjustifiable.  Even if  the risk reduction measures of Option
2 were adopted,  the risks would still  outweigh the benefits.  Accordingly,
the Acencv has selected Cotion 3 - Cancellation.
 '_]_/        Data  concerning  use  on  cucurbits  is  available only for Florida,

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          o .    Christmas Trees

               If registrations of  lincar.e  products  for use on Christmas
trees were con ringed without restriction  (Option 1),  an estimated 10,000
asoiicators (crivate Christmas  tree  orowers )  would cqn-tir.ua to be excosed
 " ~          ~                       *               I tL /
to -Li.nca.-ie via foliar, stu.~p, and trur.k treatments.  ~  Car.oer risks to
these applicators would remain  at an estimated  3.7 X  10  to 6.3 X 10
margins of safety would remain  at a  ranee of  2-37  (acute toxicity) and 4-75
( f etotoxicity ) .   Under Option 1, the economic benefits  ( uncuantif ied)
associated with lincar.e use on  Christmas  trees  would  likewise continue
unaf f ected .
                             ns  of  iir.dane  for  use on Christmas trees were
continued with amended terns and conditions (Option 2),  the following
provisions w-ouic apply.  All pesticide  products containing lindane would b
classified for restricted  use,  and  applicator certification would be
required.  The warnings to users, to  woman, and to parents scecified in
Subsection ~/.C.1.a would  be required to  appear on the labels of ail
lincar.e products.  Applicators  would  be required to wear protective
clothing and imcermeable (neoorer.e) acrons, boots, and elbow-length gloves
(Refer to Table IV-1.) Via these risk-reduction measures ,  .cancer risks
                                            -3           -4
couia se reduced , from an estimated  3.7  x  10   - 5.3 X 10   to 2 . 0 X
10   - 1 . 7 X 10  , ar.d margins  of safety  increased from 2-37 to 8-70
(acute toxicity) from 4-75 to  15-139  ( f etotoxicity ).  (Kefer to Table IV-
3 . )  The provisions of Option  2  are expected to have a mininai impact on
economic benefits .

               If  regst
trees were cancelled  (Option  2], ail  iindane-relatad risks to applicators
would be eliminated.  Given a  lack  of data  on annual usage, rhe economic
Impacts  which would result from cancellation of this use were u_-.cuar.tif i-
ahie .  Based on a  qualitative  analysis, however, the Ager.cy projects that
these inpacts will be r.inor ,  although it is possible that certain indivicuaj
growers  night experience :najor  impacts.  Cxyderr.eton-aethyi , which is
approximately 1.2  to  2 tir\es  the cost per acre of lincar.e, is available to
control  one of the target  cests , white oine weevils .  Chemical control can
also be  supplemented  by  non-chemical  cultural practices what should provide
control  over the insect  population.

               Having  evaluated the car.cer  , fetotoxic, and acute toxic
risks cosed  to aoolicators in  conjunction with lindane use on Christmas
trees, the .-.cency  has  determined that continued, 'unrestricted recistrstion
\Cption  ', } is ur.jusriiia.bie.   Option  2, which would continue registrations
with amended ter-.s and cor.dizions ,  would be acceptable in this instance
           industrv wera unavailable.  •

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only ir the reduced risks thereby achieved wers  decidedly  outweighed by
benefits.  Given the uncuantifiable benefits associated with this use
together with the availability of chemical and non-chemical  alternatives,
and given the risks which would remain  even if specified risk-reduction
measures were implemented, the Agency's determination  is that Option 2 is
unacceptable and that cancellation  (Option 3) is  warranted.   The Agency
therefore recommends that Option 3 be implemented,  a_nd cancellation of
registrations of iindane products for use on Christmas trees is  hereby
oroccsed.
               ir registrations or  iincane procucts  ror  use  on  pecans
were continued without restriction  (Option 1),  an  estimated  1200  applicators
would continue to be exposed to Iindane via  high-exposure  spray treatments.
Cancer risks to these applicators would remain  at  an  estimated  3.1  x 10  ,
and margins of safety would remain  very lev,:  approximately  4  (acute
tcxicity) and 7 (fetotoxicity). under Option  1,  the  economic benefits,
estimated at $1.4 million, associated with Iindane usa en  pecans  would
likewise continue unaffected.

               If recistrations of  Iindane for  use on oecans were continued
with amended terms and conditions  (Option 2), the  following  provisions
would apply.  Ail pesticide products containing iindane  would  be  classified
for restricted use, and applicator  certification would be  'required.  The
warnings to users, and to women, and to parents specified  in subsection
IV.C.I.a would be required to  apcear on the  labels of ail  Iindane products.
Applicators would be recruired  1) to wear protective  clothing (long-slesved
shirts,  long pants, and wide-brimmed hats) and  elbow-length  impermeable
(neoprene)  cloves, or 2 )  to employ  z. roof-type  shelter on  machinery being
used.   (Refer to Table IV-1.}  Via  these risk-reduction  measures, cancer
risks to applicators could be  reduced from 3 . 1  :< 10    to 7.5 x  10  ,
and margins of safety increased from 4  to  15 (acuta  tcxicity)  and fro.- / to
31  ( fatotoxicity} .  (?,afar to  Table IV-3 . }   The provisions of  Option 2 are
expected to have a very miner  impact on economic benefits.

               If registraticns of  Iindane products  for  use  on  pecans were
cancelled  (Option 3), ail iindane-rsiated risks to applicators  as well as
dietary  cancer risk to the general  public as a  result of this  use of the
cesticide would be eliminated.  The economic imcacts resulting  rrcm tne can-
cellation of the use would be  neciigible.  Snccsulfan is currentlv reels-
tared for cecar.s in Mississipci 'under JURA  24(c)  and has  federally
 sndosuifan  can  be  recistersd .and  used  as  a  substitute in -ost areas wnere
 ...     .          .      .  ' -;/
 iinoane  is  crurrentiv  usea.  ~
      alternatives  c-cse  ur.resscnabie  adverse errects.

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               Having evaluated the cancer, acute toxic,  and  fetotoxic
risks cosed to aoolicators the Agency has determined  that these  risks  are
unacceptabiy high and that continued, 'unrestricted  registration  (Option 1)
is unjustifiable.  Option 2, which would continue registration with  amended
terms and conditions, would be acceptable in this instance  only  if  the
reduced risks thereby achieved were decidedly outweighed  by benefits.
Given the minor economic benefits, associated with  this use,  and given  the
substantial exposure and risk which would remain even if  specified  risk-
reduction measures were rigorously implemented, the Agency's  determination
is that Option 2 is unacceptable and that cancellation  (Option 3) is
warranted.  The Agency therefore recommends that Option 3 be  implemented,
and cancellation of recistration of iindana products  for  use  on  pecans  is
hereby proposed.

          3.   Forestry

               If registrations of lindane products for 'use in forestry
were continued without restriction (Option 1),  an estimated 1000 applicators
would continue to be exposed to lindane via spray treatments•  Cancer  risks
to these applicators would remain at an estimated 1.9 x 10    and margins
of safety would remain approximately 36 (fetotoxicity)  and IS  (acute
toxicity).  Under Option 1, the economic benefits (unquantifiabie}
associated with lindane use in forestry would likewise  continue  unaffected.

               If registrations of lindana for  use  in forestry were
continued with amended terms and conditions  (Option 2], the following  terms
and conditions would acpiy.  All zestici-de products containing  iincar.e
would be classified  for restricted use, and applicator certification wcuio
be. required.  The warnings to users, to woman,  and  to parents  specified in
Subsection  IV.C.I.a  would be required to appear on  the labels  of ail iindane
products.  Applicators would be required to wear protective clothing and
aibow-iencth  imcermaabie (neoorene) gloves.   (?,efer to Table  IV-'.)   These
are the game  protective clothing recuiremer.ts  set by  the  U.S.  Tcrest
Service. —    Via these risk-reduction measures, cancer risks  could  be
reduced from  an estimated  1.9 x 10   to 5 .5 x  10 "*, and margins  of
safety increased from 36 to 42 (fetotoxicity} and 13  to 21  (acute toxicity).
(Refer to Table IV-3.)  The orovisions of Cation 2  are sxoected  to  have a


                If registrations of iindane for  use  in forestry  were
cancalisd  ,'Ccticr. 3) , ail  iindane—related  risks to  acoiicatcrs vcu_-r. oe
           u.S,  Department  of  Acriculture  Forest Service,  Southeast

           Southeastern  L'nitsd States."

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which would result frcn
However, the Agency projects that impacts wcuid be borne  by  Southern
forestry, primarily by private land owners.  Wo impact  could be  determinad
rcr seed orchards and naval stcres-oroducir.g trees .   ?.ecistered  alternative
chemicals include endosulfan and dicrotoohcs.  Recent test results  indicate
that chlorpyrifos is likely to be more effective than iindane for  use in
forestry.  Cultural practices can also be employed to supplement these
cheaiical alternatives.

               Having evaluated the cancer,  fetotoxic,  and acute toxic
risks posed to applicators in conjunction with iindane  use in forestry,  the
Agency has determined that continued, 'unrestricted registration  (Option  1)
is unjustifiable.  Option 2, which would continue  registrations  with
amended terms and conditions, would be acceptable  in  this instance  only  if
the reduced risks thereby achieved were decidedly  outweighed by  benefits.
Given the unquantifiable benefits associated with  this  use together with
the availability cf alternatives, and given  the substantial  risks  whicn
would remain even if specified risk—reduction measures  were  implemented,
the Agency's determination is that Option 2  is unacceptable  and  that
cancellation (Option 3) is warranted. The Agency therefore recommends that
Option 3 be implemented and proposes that registrations of iindane  products
for use in forestry be cancelled.  The Agency makes  this  reccrrjr.endation
for ail forestrv uses othar than those associated  with  brcadscale  blow
downs of trees.  In such a case, aerial application  of  Iindane would result
j_n lower application risks and benefit would be high.  The Agency  solicits
comments on this and will provide a specific position in  ?D  4.

          9.  Livestock

               If registrations of Iindane products  for 'use  en livestock
were continued without restrictions (Option  i), an estimated 250,000
applicators would continue to be exposed to  Iindane  via dip  and  spray-
treatments.  Sstimatsd cancer risks to these applicators  would remain 5.0  x
10 ~" and margins of safety would remain 415  (f atotoxicity) and 208  (acute
tcxicity; with no change in the risks associated with dietary exposure.
Under this option,  the benefits associated with Iindane use  on livestock,
estimated at Si,083,400, would likewise remain unaffected-

               If registrations of iindane products  for use  en livestock
were continued with amended terms and conditions  (Option  2), tne roncwir.c
provisions would aooiy.  Lindane oroducts would be classified for

products would be required to display the label warnings  to  users,  to
wccien,  and to parents  specified in Subsection  "7 . C . 1 . a .  Applicators wcuic
oe required to wear orotective ciothina and  impermeable (necorene)  arrcns,
boots,  and elbow-length  giovas.   (xefar to Table  IV-1.) Implementation of

5.0 x  10   to  1.3 x  10 " and  increase ~ar~ir.s of  safetv frcm 415 to

IV-2 . )  These "revisions are  extected to have -s. neciicibla  imcact  en
econcmic benefits.

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               iz registrations or pesticice prccucts containing iincane
for use on livestock were cancelled (Option 3), ail iir.dane-reiated risks
to applicators would be eliminated.  Alternative chemicals would have  to be
substituted for iindane, resulting in a total economic impact estimated, at
31,083,400.00.  This represents a minor economic impact, entailing no
effect on oroduction yield or auality.  However, alternatives are not  as
effective as lindane for control of mites, and a cancellation would leave
users without any acecruata means of controlling mites on livestock.  A
recent publication by the National Academy of Science (Lar.gford, 1980)
documents the recent soread of scabies among cattle in crowded commercial
feedlots and recommends the use of lindane because a single application is
effective in controlling mites.  Alternatives, including coumaphos ana
phosmet, are less effective, recuire multiple abdications, and are
believed to lead to cenetioaiiv induced resistance.  The only otner
alternative for mite control is tcxaphene, which has been presumed to pose
unreasonable adverse effects and is currently under ?_?A?. review.

               Having evaluated the cancer, fetotoxic, and acute toxic
risks posed to applicators as well as the dietary cancer risk posed to the
general public in conjunction with lindane use on livestock, the Agency has
determined that continued, unrestricted registration (Option 1) is unjusti-
fiable.  Cancellation (Option 3) would eliminate ail exposure and risk
associated with this use of lindane.  However, Option 3 would be warranted
only if measures short of cancellation would not suffice to reduce risks to
a level which is outweighed by benefits.  Given the benefits associated
with iincane usa against mites which infest livestock, and given the
decreased risks associated with the implementation of the specified risk
reduction measures, the Acencv's determination is that cancellation (Ccticn
3) is unwarranted.  The Agency therefore  recommends that Option 2 oe
implemented and that registrations of iindane products for use on livestock
be continued with specified asended terms and conditions.

          10.   Structures

               If registrations of lindane products for use in  structures
were continued without  restriction  (Option  1), an estimated 40,000
inhabitants  (10,000-12,000 houses) and 300-1000 applicators would continue
to be  exposed  to  lindane.  Cancer  risks to  these inhabitants ate applicators
would  remain  an estimated 4.6 x  10  and 4.4 x  "0 "to 3.3 x  10
respectively.  Margins  of safety  for  inhabitants would remain approximately
3  (acute  toxicity)  and  415  (fetotoxicity), while these for applicators
would  remain  approximately  2  (acute toxicity;  and 3 ;fstotcxicity} .   These

children  are  likely to  be considerably lower.  Under Cpticn  1,  the economic
benefits  (unquantiflad)  associated with lindane use on structures would
likewise  continue unaffected-


continued with amendsd  tsrms  and  conditions  (Ctticn


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Iindane products.  Anoiicators would be reouired to wear trotactive
clothing, elbow-length impermeable (naoprane) glovas and s. respirator.
(Refer to Table IV-1.)  Via these risk reduction measures, cancer risks  to
applicators couidbe reduced from an astimated 4.4x10   -3.3x10"
to 1.2 x 10   - 2.5 x 10  , and margins of safety increased from 3 to
13 (acute tcxicity) and from 5 to 3" (fetotexicity).   Risks to residents
ana their children would remain unchanged.  The provisions of Option 2 are
expected to have a minimal impact on econcmic benefits.

               If registrations cf iindane products for use on structures
were cancelled (Option 3), all iindane-related risks to applicators and  to
residents would be eliminated.  The economic impact of cancelling the
structural use of iindane is likely to be slight because infestation can be
prevented or retarded by finishing wood surfaces, where feasible, and
because, in the event of infestation,^3C? is available as an effective and
economically competitive alternative.-—   The conclusion that cancel-
lation of the powder post beetle use of Iindane will cause minimal economic
impact is supported by the fact that powder post beetle infestations spread
slowly, and that not all infestations require treatment to prevent economic
damage.

               Having evaluated the cancer, fetotoxic, and acute toxic,  and
fatotoxic risks posed to applicators and  to residents, especially children,
in conjunction with Iindane use on structures, the Agency has determined
that continued, unrestricted, registration  (Option  1) is unjustifiable.
Option 2, which would continue registrations with amended terms  and
conditions, would be acceptable in this instance only  if the reduced risks
thereby achieved were cecidedlv cutweicned bv benefits.  Given the
unquantifiab-ie benefits associated with this use, and  given  the  substantial
risks  which would remain even if specified risk-reduction measures were
implemented, th-a Agency's determination is that Option'2 is unacceptable
and that cancellation (Option 3) is warranted.  The Agency therefore
recommends that Option 3 be implemented,  and cancellation cf registrations
of iindane products for use en structures  is hereby proposed.

         1 1 .   Pineapples

               If registrations of iindane products for use  in Hawaiian
oineaopie  fields were continued without restriction (Option  1),  an
estimated  !,SOO workers would continue to  be exposed  -o iindana  primarily
via innaiation.  However, anticipated hourly excosura  (5 x 10   } is so

is estimated at  10  '",  and margins of safety at 4.3 x  10'  (acute
effects) and 2.3 x  10   (fetctoxicity).  "near Cpticn  1, the  benefits


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               If registrations cf iir.dane for use on Hawaiian  oir.eacoie
fields were continued with amended terms ar.d concisions  (Option 2),   tne
following provisions would apply.  Ail pesticide products  containing
lindanewould be classified for restricted use, ar.d applicator  certification
would be required.  The warnings to users, to women, and to parents
soecified in Subsection IV.C.I.a would be required to appear or. the  labels
of all lindaneproducts.   Although no measurable reductions in  risk  can be
attributed to  these provisions, the Agency maintains that restricted use
classification and requirements for applicator certification and label
warnincs are orudentorscautior.ary measures in any instance involving
potential exposure, howeversmaii, to lincane.  The provisions  of Option 2
are axcectad to have a negligible impact on acor.crr.ic benefits •

               If registrations cf lindane for usa in Hawaiian  pineapple
fields were cancelled (Option 3), all exposure to applicators  would  be
eliminated.  The Hawaiian Pineapple Growers Association  has estimated that
if iir.dane were unavailable for use on pineapples, the Hawaiian pineapple
industry would have to aisorb an economic loss cf 51,103,367  (1977 dollars)
over each 4-year production cvcle.  Cancellation of this use would mean
that growers would have no method cf syrr.phyiid control in  cases of late
infestations or adverse soil conditions.  At present, there  are no  non-
chemical methods of controlling  symphyiids.  Certain soil  fumigants  which
orimariiv control neinatoces heio to control svmchvlids,  but these have  no
   ..,".         ..        -             "","                 To/
resicuai action ana orrer no protection against _ate inrestatior.s . ~
Moreover, soil fumicants vacorize off the fields in very moist or
improperly prepared soil.

               Because the cancer, fetotcxic, and acute  toxic  risks
associated with lindane use on aineaoole  fields are so low as  to oe
statistically insignificant, and because  no acceptable alternatives  are
available which can replace lindane in  its roie in dual  soil  treatments,
the Agency has determined that benefits outweigh risks even though quanti-
fiable benefits  (51,013,357 •; 1977 dollars; over =ach -1-year production
cycle) are considered minor. Cancellation (Cpticn 3) is  therefore inappro-
priate.  Given the  scecial sensitivitv  oc childrsn to  the  toxic effects  o-
iindane, however,  and  given the  susceptibility of •inborn children to the
fetotcxic  effects  of  the pesticide, continued registration ;Cpticn  ')
seems imprudent even  though exposure  and  risk are very lew.   However, since
applicators  already are required  to use protective cicthing when using
f'imiganto, additional  requirements are  unwarranted because of  the
extrameiv  low carcinccenic risk.  Therefore, the Agencv  racommenc
continued  registraticn with the  general labeling precautions  spec
iindane.
          CLbrccicchlorocrc-ane  (3BC?),  athviene  cibrcmice >'ZC3),  Teicne, and

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         12.   ?et Uses

               a .    Dog Washes

                    Lincar.e dog washes are currer.tiv  available  for  use bv
both veterinarians and orivate oet owners.   If  recistratior.s  were continued
without restriction (Option 1), an estimated  15,000,000  non-veterinarian
applicators and an estimated  130,000 veterinarian  applicators would
continue to be exposed to iindane in connection  with  this  use.   Cancer
risks to these applicators would remain at approximately 2.4  x  10
(Post-application cancer risk is estimated at 7  :<  10   .)   Margins-of
safety would remain roughly 2.5 x 10   (fetotoxicity)  and 1.3  x  10
(acute effects).  (Post-application margins  of  safety are  estimated at 1.4
x 10  [fetotoxicityj  and 0.7  x 10^  [acute effects].)   However,  these
calculations apply only to adults.  Margins  of  safety for  acute effects in
children are likely to be considerably lower.   Under  Option 1,  the  benefits
(unquantifiable but assessed  in qualitative  terms  as  minor) associated witn
tnis use wou^ d continue '--na ^-1" °. c t ~d •

                    Ir registrations were continued with amended terms and
conditions  (Option 2), the following provisions  would apply.  The warnings
to users, to women, to parents specified in  Subsection IV.C.I.a would be
recuired to atcear on the labels of iindane  doc  washes.   Lincar.e cog wasnes
would be classified for restricted use, the  products  would be designated
for veterinarian apnlication  oniv, and veterinarians  would be required to
obtain applicator certification.  In addition,  veterinarian applicators
would be required to wear protective clothing ar.c  impermeable aprons and
elbow-length cloves.  (Refer  -o Table  ~/-i.)  Cancer  risks to veterinarian
apciicators would thereby be reduced  for  an  estimated 2.4  x 10    to 4.3 x
10  , and margins of safetv for  fetctaxicitv and  acute effects  would be
increased to 1.2 x  10" and 5.2 x  10   respective!-/ (Table  IV-3).
Because pet owners  would no longer be  allowed to  apply Iindane  doc washes,
nazard to this coouiaticn would  be limited to oost-aoolication  exposure.

                    If registrations  were cancelled  (Option 3),  exposure
and risk to both oet owners ar.c  veterinarians would  be eliminated.  In
economic terms, the Impact (ur.quantif iabie)  of this  cancellation is
expected to be minor.  To cancel  Iindane  doc washes,  however,  would be  to
remove from the market the pesticide  reportedly most  effective  against
scabies (mange;-causing mites.   A


(Langford,  12SO).


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In the absence of ar.v ecuallv affective alternative  to  iinclar.e for us-e
against scabies-causing mites, however, the Agency has  concluded that
Option 3 is likewise unacceptable.  Option  2  is  therefore  recommended.  The
Agency proposes that registrations of  iindane  dog washes be  continued with
the specific amended terms and conditions of  registration  designated above.

               o-   Flea Collars, joe  Dusts,  and Coc Shamcoos

                    If registrations cf lindane  flea collars, dog dusts,
and dog shampoos were continued  without restriction  (Option  1),  ar>.
undetermined -unbar of pet owners, including  children,  would continue to be
exposed to iincans in connection with  these primarily non-veterinarian
uses. —   Cancer risks would remain at an estimated  2 :< 10   (flea
collars), 1.5 x 10 "" for applicators and  1,9  x 10    post-application
(dog dusts), and 3.6 x 10   for  applicators and  2 x  10   post-
application (doc shampoos).

                    Margins cf safety  for fetotoxicity  would remain roughly
3 :< 10  (fisa collars), 33,000 (dog dusts), and  16,555  (dog  shampoos). -
Margins of safety for acute effects would remain approximately 1 .-J x 10
(flea collars), 41,500 (cog dusts), and 3,333  (dog shampoos). Post-
application y.CS for dog dusts and dog  sham.pccs would remain  at 5250
(fatotoxicity) and 4530 (acute effects) and 3S40 (fetotoxicity)  and 1920
(acute effects), respectively.   However,  these calculations  apply only to
adults.  Marcins of safety for acute effects  in  children  are likely to be
considerably  lower.  Cnder Option  1, the  benefits  (un qua ntifi able but
projected as minor) associated with these pet  uses would  likewise continue
unaffected.

                    If recistratlor.s were continued  with  amended terms and
conditions  (Option 2), the warnings to users,  to wcmen, and  to parents
specified in  Subsection IV.C.1.a would be recuired  to artear on the labels
of ail iindane flea collars, dog dusts, and dog  shampoos.   Altncugr. no
measurable  reduction in risk can be attributed to  warninc  labels, the
A—er.cv considers warning statements to be a reasonable  crecauticnary
measure in  any instance invciving  exposure  to  lindane.   Label warninc


                    If recistrations of  these  ret  uses  wore  cancelled
 (Cpticn 3), exposure and risk  to pet owners wculd  be eliminated.  Given tne
general availabili-v of effective  alternatives,  the  imract cf thess cancel-
 lations  is  extected to ba  very minor,  though  no  ruantitative assessment was
           _r.  tne  concentratrcns  necessarv lor cest centra-, _rncan= is
           tOAtc  to  cats,  but net to docs.  Cr.lv Chi: currently reccmmer.ds
           -means for  usa acainst flaas en cats .

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                    The Agencv has evaluated  the  cancer,  fete-toxic,  and
acute toxic risks posed to users and especially to  children in connection
with lindane flea collars, dog dusts,  and. dog  shampoos  and determined that
continued, 'unrestricted registration (Option  1) is  unjustifiable.   Given 1)
the imoracticaiity of any provision short of  cancellation which could bring
about .cneasursbie reductions in exposure and risk,  2)  the  likelihood that
children are exc-osed- to lindane via these pet  uses,  and- 3)  the -minimal
benefits involved, the Agency's determination  is  that Option  2 (continued
registration with amended terms and conditions) is  likewise unacceptable.
Cancellation (Option 3) is therefore proposed.  The  Agency recommends that
registrations of iindane flea collars, cog dusts,  and dog shampoos ee
cancelled.

          13.  Household uses
               c.  General Purpose  Household  Soray
               d.  Smoke Fumieration Devices

                    If registrations  of  lindane  shelf  paper,  fleer wax,
General c-urccsa household sorav, and  smoke  rustication  devices were
continued without restriction  (Cotion 1), a large  number of users and their
children would continue  to be  exposed- to  lindane in  connection witn tnese
household uses. ~'   Cancer risks would remain at approximately 3.9 :<
10 " (shelf paper), S..7  :< 10    (floor wax), 6.0  x  10  '  (household
spray), and 1.1 x 10   (smoke  fumigation  devices).   Margins of safety fcr
fetctcxicitv would re-main roughlv 5,000  (shelf paper), 1,250 (floor wax),
3.S x  10  (household spray), and 700  ( sir.cka fumigation  devices).   Margins
of safety for acuta effects would remain  roughly 3,OCO  (shelf paper;, 62~
( f locr wax), 1.9 x 10  (household soray), and 350  (smoke fumigation
•devices).  However, these calculations apply  only  to adults.  Margins o~
safety for acute effects in children  are  likelv  to ba  considerably lower.
under Gcticn 1 , the benefits (uncuantif iabie  but crojected as very mir-cr)
associated with lindane  household uses would  likewise  continue ';^naf f ected.

                    If registrations  of  iindana  household uses were
continued with amended terms and conditions (Cpticn  2),  the warnings to
users, to women, -and to  parents specified in  Subsection .17. C. '. . a  wcu_c c-e
required to appear on the labels of ail  lindane  creducts intended for
          paper  is  11,000,000.   The  number cf persons exposed to fleer wax
          is  estimated  at  '00,000,000.   The number of cerscns execsed

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                    If  registrations  of  iindane shelf paper, floor  wax,
general purpose household  spray,  and  smoke fumigation were cancelled
(Option 3), all iir.dar.e-reiatsd  risks to users would be eliminated.   The
economic impact of these cancellations is axpected to be minor,  though  da
lij.i~at.ions have precluded quantitative assessment.  Numerous alternatives
to linear.** for these household  purposes ars currently available,  including
dianinon , maiathicn, naphthalene,  paradichiorobenzene , methoxychlcr ,  and
dichiorvos .

                    Having evaluated the cancer, fetotoxic, and  acute  toxic
risks pcsad to users and  especially to children in connection with  lindane
household uses, the Agency has  determined that continued, unrestricted
registration (Option 1) is unjustif lable .   In view of 1) the ^.practicality
of any provision short of cancellation which could measurably reduce
exposure and risk, 2) the inevitable exposure of children in connection
with these household uses, and  2}  the minimal benefits involved,  the
Agency's determination is that  Option 2 (continued registration  with
amended  terns and conditions)  is  likewise unacceptable.  Cancellation
(Coticn  3) is therefore recommended.  The Ager.cv oroooses that  registrations
or iincane shelf paper, floor  wax,  general purpose household spray,  and
smoke fumicaticn devices  be  cancelled.

         14 .   Minor usas

               a .   M-L no r 'J 5 a s  Specific?. 1 ly Under  ?.g v lew  •
                    1 }    Industrial rjse .'-'.cth Scrav
                    2)    Uninhabited Builc.inc Insect Sorav
                    3}    Zmctv  Stcrace Bin F~c Strav

                          If  r scis tra tions of the above named miner  uses
were continued without registration (Option 1), an undetermined  numJter of
aooiicators would continue to  be  extcsed to lindane.  ;-ost-appIication
axtos'urs is also involved wherever industrial moth scrav is used.   Cancer
                               ~ 3                              ~ 3
ris.-;3 would remain  at  " .3 x  !0    for aooiicatcrs and  ' . " x  10    for
post-application exposure  (rncth spray), 1.9 x  10 " ( ^ininhabi ted  building
insect  spray), and  3.5 x  10    (empty storage bir. fee spray,1.  Margins  of
safety  for f 2 tctoxicitv  would remain at 2 x  iO  and 500  '.moth sorav :
apoii~atcr and post-application exposure, respectively),  135  ( 'ininhaoitac.

safety  for acute effects  would remain at 5 .x 10  and 4JC  .moth  spray:
applicator and post-application exposure, respectively;, c£  { uninhaoiteo

1,  the  benefits  ; -uncuantif iable but oro'.ected as minor,  associated  with
these uses would  likewise continue ur.aff acted.

                          it  r e c i s t r a t i c " s w e r ^ c c *~ 1 1 ~ u e d w ~- " ~. am* e "^ d e d  t e r m s
_^'  _^_4;J_'— l_t^  ' r~- *-^ ,' _ _  ^ \   „ '^ ^ _r^l •^^,.,__, _,.,.^....,' «^ ^_.— • ••", • ' ' — — -»^-"..   "".-*^l
«..O  ^.^'.H.C.^.u.^^^;.^  '.. ^ T2 ^. — O * »  *. s i   _ .. , 5 _O_— v^ iv_.^CJ ^__/v_ci__Vj..i f*^, ~. „ v. z~ •- -* ^. t •  ...^-

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v» czn3ii y cLnci ^*o c-cijrsjrz'^s  stDSC'^jLsci ^ ^ 3LIJDS^"""tuLor  T"V 0 1  2. woxi^ '"^ '"*'o  "*"^<~-i7~i ~^^  ~^
appear or. the labels  of these products.   The  provisions of Option  2  are
expected to have  a  negligible imract en economic benefits.

                          If registrations wara cancelled  (Option 3),  all
exposure ar.d risk associated with these minor  uses would be eliminated.   No
data concerning  the economic benefits of  these uses are available  to  the
Agency.  In the  absence of such information,  given the lengthy public
notice and the attempts by the EJr.V'USDA/State  assessment team to obtain
data the Agency  must  proceed on the assumption that ths economic impacts  of
these cancellations would be sini~al.

                          *n r/j_ev/ or tne ca.ncer /  retotox—c , and acute  tcx~c
risks oosed to applicators in conjunction with those  r\incr uses  which  are
specifically under  review, ar.d in view of the  ir.inisal benefits involved,
the Acencv has ceta.rr.ined that neither Ootion  1  (continued, unrestricted
registration) nor Option 2 (continued registration with amended  terns  and
conditions) is justifiable.  Option 3 (cancellation)  is therefore
reconiaended,  The Agency proposes that registrations  of the ainor  uses of
lindane be cancelled.

               b,  gther^J-lincr Uses

                     In addition to  chose  minor uses of lindane specifically
under review,  the numerous other minor uses of lindane are reccnmencad ;or
cancellation.  These  include use of lindane on lettuce, rnushrocms,
tomatoes, apples, apricots, asparagus, broccoli, Brussels sprouts,  cabbage,
cauliflower, celery,  cherries, ccilards,  eggplants, grapes, guavas,  kale,
kohlrabi, r.ancoes,  tr.ustard greens,  nectarines, okra,  onions, peacr.es,
—^ 3* JT "5 / C^-S ^^"::'"r"S   ™! 1 ^ • *~i •£:  ~ r^ ", t* z". f *i  r" ''""Ct:vS   ;~"C.1'"^ W« ~* *" ~^~"" "^ S '"'"^O o'^'SS  C"2.'r"sZ*
Together these  croo uses likely account for a- sizable proportion or  tne
dietary intake  and  risk (Table II-5).

     3.   Sumciajrv of  Prcpcsad ?.egulatcrv  Sacisior.

          1 .    Hardwood Locs and Lurrh-er

               Option 3.  Cancel rsclstrations to take effect  after  two
 racuirsc.   Specified warnings  to  users,  to wccsn,  and to parents  :r.ust
 appear  en  the labels of all lindane  products.  —'   .Applicators  will  be

 -cots,  and eibow-iencth neotrene  cicves).

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               Option 3 .   Cancel registrations •

          3.   Ayecaccs

               Cpticn 3.   Cancel registrations.

          4.   Orr.aiTisr.~i Is

               a .    CoB-j.erciai Us a

               Option 2.   Cor.tir.ua  registrations  with  the following  arne-dec
terzis and conditions of registration,   lir.dans products for ccrrcrierc^ai  i.iS2
will b« classified  for restricted.  U3a,  and applicator  cartificaticn  will  be
racuirad.   Specified war~incs to users, to wcraen,  and  to pa.rsr.ts ricst
appear or. the  labels of all lir.dane products.  Cc~~.=rcial applicators  will
be rscruired to wear trctscti"/e clcthir.a (lor.c-siaeved  work shirts  ar.d  -or.g
pants), slbcw-iar.gth jjsip-errr.eable  (neoprana) cloves,  and a respirator.

               b .    Hor.eowr.er Us a

               Option 3.  Cancal  racistratior.s.

          5.   Cucurbits

               Octicn 3.  Cancel  raciscraticr.s ,
                CT3tJ.cn 3.   Cancsl racriscratior.s
 :arr.s  ar.d ccr.citior.s  of  registration.   lindar.e  prccucts w^__  -e

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               Option.  2.   Continue registracicr.s  wi~h  tha  following
air.endriant to  the  tar-;S an-d conditions of registration.   Specified warnings
to users, ~o  women /  and to parents ."nusc accear en  the  labels of ail lindana
produces .

         12.   Pst^ Us as

               a. .    Dec Washes

                     Option 2.   Continue recistz'aticns  with the follcwinc
amended  terras  and  conditions,   Lir.dana produc-s will be  classified ;'or
rss~xicted  use and  iiraitsd to  vatarinarian aaolications  onlv;  acnlicator
certification  will  be  rscniired.  Soecified warnings  to  users,  co women, ana
to parents  rr^jjst  acceaj;' on ths  labels of all lindane  orcducts •   Vatarinarian
acolicatcrs will  be  recuired to wear protective clothing (long-sleeved work
shirts and  long  pants), elbow- lang-ch i-r.perneable  (~eoprene)  gloves and
neoprane aprons.

               h-    Flsa Collars ,  Doc Dusts,  and  Doa Sh^ain'ooos
                     Option 3.   Cancel registrations •

          1 3 .    Ho use h o 1 a U s e s

                Option 3 .   Cancel registrations .
                Cotion 3 .   Cancel recisr.ration3 .

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                       Lir.dane :  Position  Document 2/3

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Xohnen , R. , K, Haider,  and G., Jagnow. 1975. Investigations  on t±ie microbial
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   ?ss~ioides :   lectures held at the IUPAC Third  Intarr.ational  Concress of
   Pesticide Chemistry, Heis^nski, 3-9 July 1974,  ed.  ?. Coulscon and F.
   Kcrte .  Znvircmr\en~al Qualitv and Safatv Suocle-Tsent Vol.  ZII .
                                                                   14
Koransky,  W. , and 5.  Uliberg. 1954. Distribution  in cha brain cf '  C-
   benzsnehexachlori'de :  aur.oradiograohic s~udy. Biochera. Phamacoi . 13:
   1537-1538 ,


   Arch.  Der~atcl .  Syor.iiccy [no vol.] :  407-412.

Kulash, w.M.  1953.   Insectlcically trsa'ced sesc  for  virevcrm control.
   J.  £con. Sntomoi .  46:433-441-
.
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Litterst, C.L.,  and  E.  Miller, 1975. Distribution of lindana in brains  of
   control  and  thencbarbitol orstreated docs  at  the onset of iindane—
   induced  convulsion.  Bull. Envircnn. Contain,  Tcxiccl.  12:  519-524.

Long, Vi.H.  and  J.H.  Lilly.   1953.  tfirewortr. behavior in  response,  to
   cnenicai  seed  trea.trr.snts.  J.  Ecor.. Snto™cl,  55 : 29 1 — 295.

Long, rt'.H.  and  J.K.  Lilly.   1953.  Effects of chemical  seed treatments  en
   wireworn  activities.   J. Econ.  Er.tcrr.ci. 52:509-511.
                                                           14
Mathur , 3.P. and  J.G.  Sana.  1977, Degradation of  iindane   C in a mineral
   soil and  in  an organic soil. Bull. Environs.  Ccntam.  Toxicoi.  17  (4) :
   424-420 .

Matsusiura,  ?.,  H.J.  Eanecat, arc K.C. Patil.  1976.  Factors affecting
   micrcbiai rr.ataiclisti of ^-SHC. J. Pesticide  Sci .  1  (1): 3-3.

Meister, R.T.,  ed,  1973.  Jam chenicais handbcok.  Wiliouchhy, Ohio:


Meir.c. "Jndated a.  Proposed regulation, Section 25(b)(1),  ?I~RA,  exemption
   of nav hunian drugs  from EIEP-A recuirar'.ents—AC7ICN  MEMCSANCCM. 7rc~
   Steven D. Jeilinak,  Assistant Administrator  for  ™o:
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Meno  1980 a.  Status  of epidemiology study  in  Hawaii—1 in dan a and blood
   dyscrasias,  dated February 23, 1930. Frcm Chris Chaisscn, -Toxicology
   3ranch/K£D,  to  Richard Trees-, Pro j act Manager for lindane, 3PPJ3.
   Attachments:   2  progress reports.

Mano  1980b.  Cost  of i.in dan a arioiication,  dated  June 13,  1S80.  ?roa uerrv
   A. Moore,  Head,  Section 2,  Chemical  Preview 3ranch 3 [5??JDi , to Robert
   Brown, Chief,  Chemical Review Branch 3 (SPK.D; ,

Memorandum  from Peter 7.  Infants, Director,  Office of Carcinogen
   Identification and Classification, OSKA,  to  Grover Wren,  Director,
   Health Standard  Program, CSKA, datad June  16,  1978.   Citad in Rational
   Association  of Farirworkers Or ganizations ^_et  al. v.  ?.ay Marshall, U.S.
   Court of  Appeals,  D.C. Civil Action No. 79-1044

Mohrraann, X.  1976.  Acute  i:ihalation toxicity:   LD^  report no. 76002.
   Read  and  Carnrick Research Institute,  Kanilworch,  M.J.  (Unpublished.)

Nagasaki, H., S, Tcrnii, T.  Mega, M.  Marugani, and N',  Ito.  1973.
   Carcinogenicty of benzene hexachloride (3KC).  In Topics in chemical
   carcinogsr.es is ,  ed. W. tfakahara,  S.  Takayajna,  T.  Sugiaiura, and 5.
   Odashiisa,  pp.  343-333. Baltimore, Md. :  University Park. Prass.  [Cited
   in Position  Ccc'jrierit 1. I

Maish-cain,  S.Y.,  and D.L. Leibovich. 1971. iff set of snail doses of DDT and
   lindane  and  their -taixture on sa;o. 124S.   T^x.

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Psrkins,  Z.A.  a_r.d 7-..J. Harvccd.   1959.   Zvaluacicn  of  32sd crea^irr.2.~~3  for
   control  cf  wirswcms on dry  land cereal crair.s .   No.  255.  Insecticide
   and  acaricida  tascs.  Volume  4  pace  172.  Zr.nc.~cl.  Sec. of America.

re.rsscu, S. T. , V.  Dobra, M. Leibovich,  3. Perrsscu,  arr.d S. A. Ghalbarg.
   1974.  Studies  of the sffac~3  of lorg-::err. administration cf
   cr~ar.ochiorat:e oaszicidas (.lir.dar.e,  CDT) or. ~ha  vr.ita labcra~orv  rac.
   Rsv. Med. Chirurc, lasi (4).  (Cited  ir. Pcsicior:  Dccxiranr 1.J

?HS.  U.S. Public  H-ealch Service.  1952.  Evaluation, cf  public health hazards
   associatiad  wizh  the use of econcnic  coisor.3 :   rachr.ciocy 5urrir.ary  cf
   ac-iviti2S  -o. 32, Cc-.-Dac.  1952, project; no. 74-T-11 . Savar.r.ah,
   Georgia.

Pclishuk, 3.W., 'A.  ?.cn, M. Wassemar.r,,  5- Cucos,  D.  "sassarnar.r., and  C.
   Larnesch.  1977. Crgar.ochlorir.e  cc.Tipcur.ds in hun\an blood plasma  ar.d ~iix.
   ?esc.  Men.  J.  10 (4):   121-129.
                                      .  "as rii
   froscnas  uncar der sinwirkur.g  von j-he.xachlcrryklchexan .  Ac-a 3iol.
   .'•!sd. Gar™..  2i:  205 — ^12.

Severn., 0.  1973.  Ar.alysis of  human  exposure -o CSC?.  Cri-sria ar.d
   Evaluacior.  Division, "J . S .  EnvironrAantial ?ro~sc~ior. Acsr.cv,  Wash.-r.s-cr. ,
   D.C. (Unpublished.)


   tc  -ha  herbicide, parscuaz.  Bull. £r.vircrjn. Ccn-ari.  Toxicoi .  14  (3):
   vor.^-HCH. )  Cherr.csphar=  4:   221-225.
   Ccicar.y.
  iemvar.dt.er,  H. "and H.  Schul^er; .  197£b. £:-:-sri~sr.-3 cr. lindar.e

    assr.ar-.,  c.C., ar.j; 7 . "v.  xurr. .

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Thorpe, E., and A.I.T.  Walker.  1973. The toxicology  of  diaidrin (KF.CD). II.
   Comparative long-tern oral toxicity studies  in nice  with dieldrin, CCT,
   phenobarbitone,  2>~5HC and£i~3HC. Fd. Cosast.  Toxicci.  11:  433-4-',2 .
   [Cited  in Position  Dccunient 1 . ]

Trivonva,  T.X., Giacenkc, I.M.,  ar.d Shuiyak, V.D.   1970.   Zffect of garraa
   BHC and serum  on  reproduction.  Yeterinariya  47 (6):   91-93.  Abstracted
   i.r.  1973 evaluations  of seme pes~icic-e residues in food.   1974.   Ser.sva:
   Worid Keaith Association.

Truhaut, R.  1954.   Ccuir\unicat.ior.  au syt^GCsiuzi  in~srn.  da la orsventicn du
   cancer, Sao Paulo.   Cited in Food and Agriculture Organization/World
   Health  Crganizacion.   1967.   Evaluation of acne  cesticids residues in
   food.   [Cited  in  Position Document l.j

Tu, C.M.   1975.   Utilisation and  -decradaticn of  lindane bv soil siicro—
   craanis~s.  Arch. Micrcbici.   1QS:
University cf  Iowa.  1980,  Lindane special s'tudy,  Dr.  K.W.  Xirby, Project
   Dirac~or. University of Iowa - Epic/eniclcgicai  Studies  Program
   (Unpublished.)

University of  Miami  Memo.   1979.  Kwall Poisoning,  dared NcverrJoer 13,  1979,
   Fran Dr.  Bob  Cunoan/UMS-M to Dr. Sill Stevenson.   AC'cac.hrr.encs (4)-

U.S. Department  of Acricultiiral ?orast Service.   1979.   Insscricides for
   the southern  cine beetle-   Southern oine beetle  fact sheet no. 2.
   Atlanta,  Gaorcia.

U.S. Dapar~~er.t  of Health, Education, and Welfare.   1974,   Criteria for a
   rscoEE-ancsd standard... occupational exposure  co cotton dust.  HZ",-i
   ?'-Lbiication no.  (>iIGSH) 75-11S.  Washington,  D.C.

WA?^F.  v/arf  Institute,  Inc.  197C .  Methodology  for S~,o-Ciouc iir.dane  lest
   .Report no.  01021 IS.   Madison, wis .  ( Unpublished . }

White, G .L . , and M.G.  larrabee .   1973.  Phosohoinosicides  and other

   Meurochen.   20:

'*>' CO .i. JT I. C CTS   W , ^ .   1 S J~<3 .   ' J'" 3 CS_m~i.:i j_SC™ S "^  3^  '"* r1 X3.C (*3 " S " " ~'-'.-

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