REPORT





      of the





  L I  N  D A N E





 ADVISORY





COMMITTEE
   July 2,  1970

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                 REPORT OF THE LINDANE ADVISORY COMMITTEE

RECOMMENDATION:  The Committee recommends maintenance of the cancellation
of registration of all  lindane products intended for vaporization.   This
includes all products listed in Exhibit 4.
INTRODUCTION AND BACKGROUND
On April 28, 1969, the Department of Agriculture cancelled the registra-
tion of lindane products intended for vaporization.   These products had
been registered under the provisions of the Federal  Insecticide, Fung-
icide and Rodenticide Act.  Questions regarding the  safety of these
products have been raised repeatedly since the first registrations  were
made in the early 1950's, but there was a dearth of  evidence either to
support definitive proof of safety or to demonstrate a genuine hazard
from the products when used as directed.

The General Accounting Office in its study and report of February 20,
1969, recommended that the Secretary of Agriculture  should review the
Agricultural Research Service's policy of registering lindane pellets
with a view toward resolving the question of safety  to human health.

During the period from 1951 to present, evidence bearing on this matter
has been accumulating.  The Department of Agriculture collected the avail-
able information, appointed an Advisory Medical Panel consisting of
Bertram D. Dinman, M.D., D.Sc.,  Victor A. Drill, M.D., Ph.D., and
Ted A.  Loomis, M.D., Ph.D., and asked them to review the subject of lindane
vaporizers.

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This panel met January 8, 1969, and issued a summary report addressed to
Dr. Harry W. Hays.  The panel gave weight to the association of blood
dyscrasias with lindane vaporizers, the ability of lindane vapor to
penetrate and persist in foods (unless they were sealed in metal or glass),
and the availability of less persistent but equally effective insecticides.
It was the consensus of the Medical Advisory Panel that the use of lindane
by automatic or semi-automatic vaporization techniques should be dis-
continued because it created a hazard potentially detrimental to human
health.

In February 1969, the results of new laboratory tests by the Department
of Agriculture using a continuous lindane vaporizer operating under
approved conditions in a simulated restaurant situation became available.
These  results confirmed the ability of lindane to penetrate and persist in
exposed foods.  Additionally, the available knowledge about the toxicology
of  lindane was reevaluated by the Department.  The conclusion was reached
that continued registration of lindane products intended for vaporization
is contrary to Section 2 z (2) (c) and 2 z (2) (g) of the Federal Insect-
icide, Fungicide  and Rodenticide Act and that such registrations should
be canceled.

Registrants were  advised of the cancellation action against  lindane products
intended for vaporization.  Certain firms exercised their appeal rights by
petitioning for a referral of the matter to an Advisory Committee as
provided under Title 7, Chapter III, Part 364 of  the Code of Federal  Reg-
ulations.  Under  these provisions the National Academy of Sciences--

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National Research Council was asked to suggest potential candidates for

the Advisory Committee and the Department of Agriculture then appointed

the following individuals:

     J. T. Litchfield, Jr., M.D., Chairman
     D. G. Crosby, Ph.D.
     W. B. Deichmann, Ph.D.
     M. B. Shimkin, M.D.
     J. C. Street, Ph.D.

The Advisory Committee was requested to consider all relevant factors

and submit a report and recommendations as to the registration of the

articles subject to the appeal together with all underlying data and a

statement of the reasons or basis for the recommendations.


The Committee met in Washington, D.C. on April 27, 1970, to receive its

charge, consider the Exhibits and References (Appendices 1  and 2) dis-

cussed  below and to obtain technical advice from the Agricultural Research

Service Staff.  The Committee met again on the morning of April  28, 1970,

to hear and discuss the presentations by the registrants who had appealed

and asked to be heard.  In the afternoon of that same day the Committee met

in executive session in order to reach a consensus.  The meeting was then

adjourned with the intent of handling any further developments by mail if

possible.  Appendix 3 presents details of the proceedings of April 27 and

28, 1970.


REVIEW OF THE HEALTH ASPECTS OF LINDANE


The Committee has undertaken its assignment with full recognition that

insecticides are an essential component of our civilization.  It was

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necessary therefore to consider the public health aspects  of the use of
lindane as well  as all relevant factors which pertained to the specific
cancellations of registrations of lindane products intended for vapor-
ization.

The Exhibits and References provided to the Committee are  listed in
Appendices 1 and 2.  Of the Exhibits, 1 through 7, 9 through 12, 14 and
16 were found to relate to background information helpful  in orienting
the Committee.  The remainder and all of the References pertained in
some measure to health aspects of exposure to lindane (E 15 and R 8 are
identical)*.  It was to this material that the Committee directed its
attention in particular.

It should be noted that essentially this same material  had been studied
by a Medical Advisory Panel (E 13), the members of which gave weight to:
(a) the association of blood dyscrasias and lindane vaporizers, (b) per-
sistence of lindane and its ability to penetrate food products (unless
specially sealed in metal or glass), and (c) the availability of less
persistent and equally effective insecticides.  Their consensus was that
use of  lindane by automatic or semi-automatic vaporization techniques
creates a hazard potentially detrimental to human health and therefore the
sale of lindane for such use should be discontinued.  The present Committee
decided neither to accept nor reject the consensus of the Medical Advisory
Panel because there was no available documentation of the manner in which
their consensus was reached.  Accordingly the Committee reviewed in depth,

* E = Exhibit - R = Reference - AE = Additional Exhibit

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all available information in order to reach an independent conclusion.

THE TOXICOLOGY OF LINDANE
Lindane is relatively stable in the environment.   It is persistent in
soils but is biodegradable there under wet anaerobic conditions (AE 2).
In mammals there are mechanisms for metabolism and excretion of this
pesticide.  Lindane is not cumulative in blood (E 19),  or rat fat in
which it is very soluble (R 11).  While metabolism of lindane in the
human body is apparent, in an inert environment this pesticide is
extremely persistent and disappears essentially only by volatilization.
For example, six and twelve days after a room was sprayed with lindane
the air contained 0.18-0.19 micrograms of this compound per liter (66%
of the original concentration)(E 22).  In another case, residues of 26%
of the original amount of lindane sprayed on either painted walls or
plywood panels were present after 179 days (R 14).  Still another example
of its stability and persistence may be cited wherein cloth was impreg-
nated with lindane and then laundered three times.  Only 36% of the
lindane was removed, apparently leaving 64% as a residue [R 23).

These properties of fat solubility, stability, persistence and ability
to vaporize continuously lead to lindane's ready penetration into food
(E 8, R 9, and 15), into the body of chickens and then  into the yolk of
their eggs, (R 12 and 16), and into exposed humans (E 19).

These are all examples which underlie the need for concern about the
public health aspects of lindane toxicity.  Animal studies of lindane

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toxicity have neither been  comprehensive  nor  reassuring.   Lindane  vapor
in concentrations of 0.2 micrograms  per  liter is  fatal  to  canaries,
budgerigars, and fish (R 9,  AE  4).   Lifetime  feeding  of lindane  to rats
indicated that the no effect level was between 10 and 100  mg/kg/day  by
mouth.  The compound was not carcinogenic in  this study (R 2), nor in
a study in rats reported by  Klimmer, O.R.,  Arch.  Exp.  Path.  & Pharm.,
227, 183-195, 1955, nor in  a limited study  in which four beagles were
given 15 mg/kg for 15 months (Treon, J.F.,  et_ aj_, J.  Agric.  & Food Chem. ,
_3, 402-408, 1955.  A dose of 10 mg/kg per os  was  not  tolerated (liver
damage) by dogs over an 18  to 49 day period (R 2).  Fifteen  mg/kg  was
lethal to dogs after two doses  (R 14).   Inasmuch  as lindane  is not
strongly cumulative in animals  or man (E  19), consideration  of the acutely
toxic dosages is especially important.  Tabulated below are  the  single dose
LD5Q values for lindane in  the  rat,  rabbit, and dog,  by both oral  and
intravenous routes.
                                        n
     Species _ Oral _ Intravenous5
Rat
Rabbit
n
Dog
Man(estimated)
185d
80C

25C
5C
7C
7C
4.5b
4b
0.5C
     a.  Inhalation and intravenous I^Q'S  are assumed to  be identical.
     b.  (R 1), c.(R 14), d.(R 19) In rats  on a low protein  diet the
         LD50 was 95 mg/kg.

These data when extrapolated to man suggest an oral LD50 of  5 mg/kg  and
an intravenous or inhalation LD50 of 0.5 mg/kg.  It is evident that

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lindane is a highly toxic substance.   Its acute effects  are  mainly  on
the central nervous system; longer term effects involve  liver  damage.

The estimated human ID™ values can be compared with  some  actual  and
projected results in man.  Six of 35  healthy adult patients  given 45 mg
of lindane in an emulsion had severe  toxic effects including in one
individual, a ten minute convulsion (E 21, R 6).   For a  70 kg  man this
dose is 0.64 mg/kg or about 1/8 of the estimated human oral  LD5Q.

In the matter of inhalation, it makes little difference  whether the
chemical is continuously vaporized or applied as  a one shot  fumigation
(repeated no sooner than two weeks) because in either case the concen-
tration of lindane vapor maintained,  will be of the order  of 0.2
micrograms/liter of air (E 22).  The  concentration of lindane  vapor in a
space containing substantial residues following fumigation will depend
on a number of variables.  In particular, the temperature  is important
because the saturated vapor concentration of lindane  in  equilibrium with
air, will vary from 0.26 at 15°C. to  1.78 micrograms/liter at  30°C.  It
has been shown (R9) that when lindane is applied continuously  at  a  rate
of 10 gms/24 hrs/13,000 cu. ft. which is slightly more than  1/2 the
single recommended dose from the "one shot" fumigator, by  48 hours  the
air in a room at 29-34°C. contained 0.2 micrograms per liter.  This room
had air circulation, but only minimum ventilation associated with pers-
onnel entering and leaving.  When such a rate of application of lindane
was continued the air concentration leveled off at 0.54  micrograms  per

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8

liter.   After discontinuing the application of lindane it required 10
days for the air concentration in this  heavily contaminated room to
decrease to 0.27 micrograms per liter.   Thus the figure of 0.2 micro-
grams per liter  of air regardless of device, appears  conservative.

A normally active adult breathes 850 liters/hour or about 20,000 liters/
day.  He could thus inhale 4 mg of lindane/day from the above concentra-
tion.  Since the inhalation LD5Q for a  70 kg man was estimated to be
35 mg this would amount to 1/9 of a possibly lethal  dose for each day of
continuous exposure.   A slightly different method of extrapolation led
to an estimated human LD5Q of 32 mg (R  14).  These potential  exposures
are 4.5 times greater than the WHO-FAO  acceptable daily oral  intake of
lindane and thus as much as 45 times greater than might be acceptable by
inhalation.

Up to August 1953 there were 44 known human cases of lindane intoxication;
of these, 31 were associated with either vaporizers  or fumigators (R 14).
From 1954 to 1969 the Department of Agriculture recorded 37 accidents
involving lindane (E 18).   In these there were seven deaths among children
one and one-half to eight years old, of which six were known to be due
to ingestion of lindane pellets (AE 7).  The Council of Pharmacy and
Chemistry of the American Medical Association has repeatedly called
attention to the hazards posed by the practice of vaporizing lindane in
space occupied by humans (R 3,4,8 and 10).  Peripheral neuritis and
aplastic anemia are examples of possibly insidious effects from chronic

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exposure to lindane.

CONCLUSIONS AND RECOMMENDATION
The Committee was impressed by the incomplete toxicologic data available
on lindane, especially long term studies of chronic effects.   There is
a dearth of both laboratory and epidemiologic studies.   The members of
the Committee urge that adequately controlled studies be undertaken in
industrial and other human populations with long term exposure to lindane
and/or other pesticides.  Adequate laboratory studies should  support the
investigations in man.  Studies on the effects of combinations of pest-
icides should be mandatory whenever a registration involves such  a
combination.  However, existing data are sufficient to indicate the
reality of human hazard.  There are four areas which are clearly  not open
to argument.  First, the closeness of the observed or calculated  levels
of lindane from vaporizing devices to the toxic threshold,  is supported
by many clinical examples; second, continued high dermal and  respiratory
levels persist in rooms fumigated with lindane devices; third, it is a
certainty that crawling infants, the sedentary, and the bedridden will
receive higher exposure than the literature would indicate, and fourth,
the attractiveness and availability to children of lindane  for use in
vaporizers is obvious.

The Committee was concerned with the fact that lindane tablets and powder
are readily available in supermarkets, drug stores, etc.  The powder in
envelopes has been mistaken for sugar (R 10), and the pellets resemble
aspirin or antacid tablets.  Both forms of lindane have been  ingested

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10.





with serious and even fatal  consequences (E 18).   The Committee felt



strongly that a substance as toxic as lindane should not be ubiquitously



available to the general public.   We concurred with the premise expressed



by Dr. DuBois (E 17) that "it is  always unsound to expose human beings



to the same concentration of a poison as the insects which you wish



to destroy," if such exposure is  routine or continuous.





However, the committee makes a clear distinction  between the acceptable



practice of applying suitable concentrations of lindane as directly as



possible onto susceptible insect  pests and in their immediate envir-



onment, as opposed to the unacceptable practice of creating a generally



insecticidal environment.





The consensus of the Committee was that lindane should not be used to



create and maintain an insecticidal atmosphere within space occupied by



humans.  Because there is not sufficient benefit  to offset the risk of



intoxication, the prophylactic use of lindane cannot be justified.





Because of these considerations the Committee unanimously recommends



that:



The cancellation of registrations of all lindane  products intended for



vaporization should be maintained.  This includes all products listed



in Exhibit 4.
 John  T.  Litchfield, Jr., M.D.,Chairman          Date

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11.

ADDENDUM:

The names of individuals who contacted the Chairman or members of the
Committee outside of the meeting and the substance of the conversations
were as follows:
     1.  Mr. Louis A. McLean representing Continental Chemiste
         Corporation called the Chairman by telephone early in
         March 1970 to advise that he would like to present a
         statement to the Committee and that Dr. Mitchell R. Zavon
         of the Agatha Corporation would make a technical presentation.
     2.  On May 4, 1970, Dr. Robert Mobbs telephoned the Chairman
         asking for information regarding the Committee and its
         intentions.  He claimed to have done work on lindane in the
         1940's and stated that it may be an antimetabolite to
         inositol.  He was given no information that was not a matter
         of public record.
     3.  May 22, 1970, a representative of Environment Magazine
         (St. Louis) contacted Dr. D. G. Crosby for information
         about committee activities.  He was referred to, but did
         not contact the Chairman.

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 APPENDIX 1

                         PART  I-EXHIBITS
 1.   Statement of United  States  Department  of  Agriculture  position
     regarding lindane  vaporizers.

 2.   Federal  Insecticide,  Fungicide,  and  Rodenticide Act,  1964.

 3.   Rules  governing  the  appointment,  compensation, and  proceedings
     of an  advisory  committee; and  rules  of practice governing
     hearings  under  the Federal  Insecticide, Fungicide,  and  Rodenticide
     Act,  August 29,  1969.

 4.   Petitioners for  advisory  committee or  public  hearing.

 5.   Petitions for advisory  committee  or  public  hearing.

 6.   Comptroller General  of  the  United States.   Report to  Congress.
     Need  to  resolve  questions of safety  involving certain registered
     uses  of  lindane  pesticide pellets.   Feb.  20,  1969.

 7.   Interdepartmental  coordination of activities  relating to
     pesticides, by  the Department  of  Agriculture, the Department of
     Health,  Education, and  Welfare,  and  the Department  of the
     Interior.  1964.

 8.   Pesticides regulation Division,  ARS.   Lindane vaporizer test,
     February, 1969.

 9.   Letter,  G. W. Irving, Jr. to L.  J. Gehrig,  regarding  cancellation
     of registration  of lindane  products  for use in vaporizing devices.
     April  24, 1969.

10.   Notice of cancellation  of registration of lindane vaporizer products
     April  24, 1969.

11.   Notice to manufacturers,  formulators,  distributors, and
     registrants of  economic poisons.  Cancellation of registration
     of lindane products  intended for  vaporization.  PR  Notice 69-9.
     April  28, 1969.

12.   Other  actions relating  to cancellation of lindane products
     intended  for vaporization:

       a.   USDA press release, 1347-69.   USDA  bans use of  lindane
           insecticide  vaporizers.  April 29,  1969.

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      b.   Notice to State regulatory control  officials, May  26,  1969.

      c.   Notice to State regulatory control  officials, June  20,  1969.

      d.   USDA press release,  2485-69.   Companies  appeal  USDA ban on
          use of lindane insecticide vaporizers.   August  11,  1969.

13.  Opinion of collaborating  advisory  panel  on  the  subject  of lindane
     vaporizers.  March 17, 1969.

14.  Letter, N. D.  Bayley to Philip  Handler,  requesting selection of
     an advisory committee to  study  problem  of lindane vaporizers.
     July 23, 1969.

15.  American Medical  Association.   Council  on Pharmacy and  Chemistry.
     Health problems of vaporizing  and  fumigating  devices for
     insecticides.   Amer. Med.  Assn. Joun. 152:1232-34, July  25,  1953.

16.  Registration policy for lindane vaporizers.   October 17, 1961.

17.  U.S. Department of Health, Education, and Welfare.   Public Health
     Service.  Ad Hoc Committee report  concerning  pesticide  vaporizing
     devices.  September 22, 1966.

18.  Memo from Currie to Bowen, tabulation of accidents.

19.  Milby, T. H.,  Samuels, A.  J.  and Ottoboni,  F.,"Human exposure
     to lindane; blood lindane  levels as a function  of exposure."
     Journal Occup. Med. 10:584-587, October, 1968.

20.  Letter, Yoss to Hays concerning use of  lindane  vaporizers.  Feb.  7,
     1969.

21.  Letter, W. S.  McLeod, Canada  Department of  Agriculture  to Justus
     C. Ward, Hazard of lindane by  continuous vaporization in Dwelling.
     December 2, 1960.

22.  Letter, Wayland J. Hays,  Jr.,  DHEW to Justus  C.  Ward, lindane
     vaporizers.  July 2, 1959.

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APPENDIX 2
                    PART II - REFERENCES
1.  McNamara, B.P. & Krop, S.
         Observations on the pharmacology of the isomers of
         hexachlorocyclohexane.
         J.Pharm. Exper, Therap. 92:140-146 Feb. 1948.

2.  Fitzhugh, O.G., Nelson, A.A. & Frawley, J.P.
         Chronic toxicities of technical benzene hexachloride
         and its alpha, beta and gamma isomers.
         J.Pharm. Exper.Therap.  100:59-66 Sept. 1950.

3.  Amer.Med.Assn. Council on Pharmacy and Chemistry. Committee
         on pesticides
         Toxic effects of technical benzene hexachloride and
         its principal isomers.
         JAMA 147:571-574 Oct. 6, 1951.

4.  Amer.Med.Assn. Council on Pharmacy and Chemistry. Committee
         on Pesticides
         Health hazards of electric vaporizing devices for
         insecticides.
         JAMA 149:367-369 May 24, 1952.

5.  Leland, S.J.
         Some observations on the toxicology of lindane.
         Chemical Specialties Mfg.Assn.Proc. 38:110-112 June 1952.

6.  Leland, S.J.
         Appropriate use of vaporized lindance in insect control.
         Unpublished ms. (1952)

7.  Kettering Lab., Cincinnati,  Ohio.
         Responses of experimental animals to intermittent exposure
         to air bearing freon-propelled aerosols of peanut oil with
         and without lindane.  June 1953.

8.  Amer.Med.Assn. Council on Pharmacy and Chemistry.  Committee
         on Pesticides
         Health problems of vaporizing and fumigating devices
         for insecticides.
         JAMA 152:1232-34 July 25, 1953.

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 9.   Queen, W.A.
         Distribution and adsorption charateristics  of
         vaporized lindane
         Assn.Food Drug Officials.  Quart.Bull.  17:127-139 Oct.  1953.

10.   Amer.Med.Assn.  Council  on Pharmacy and Chemistry.   Committee  on
         Pesticides
         Abuse of insecticide fumigating devices.
         JAMA 156:607-609 Oct. 9,  1954,

11.   Sedlak, V.A.
         Solubility  of benzene hexachloride isomers  in rat fat.
         Tox.Appl.Pharm. 7:79-83 1965.

12.   Deema, P., Naber, E.C.  & Ware, 6.W.
         Residues in hen eggs from vaporizing insecticide tablets.
         J.Econ.  Entomol. 58:904-906 Oct.  1965.

13.   Loge, J.P.
         Aplastic anemia following exposure to  benzene hexachloride
         (1indane).
         JAMA 193:110-114 July 12,  1965.

14.   Joint Statement of the Public Health Service  and  the Food  and
         Drug Administration - Appraisal of the  health hazard of
         vaporized lindane.  1965.

     Interdepartmental Committee on Pest Control - A statement  of
         the health  hazards of thermal  generators  as used for the
         control  of  flying insects. Sept.  21, 1951.

15.   Markarian,  H.,  Pratt, J.J., Jr., Kane, F-  & Kantack, B.H.
         Insecticide residue in foods subjected  to aerosols under
         simulated warehouse conditions.
         J.Econ.  Entomol 59:844-846 Aug. 1966.

16.   Whitacre, D.M.  & Ware,  G.W.
         Retention of vaporized lindane by plants  and  animals.
         J.Agr.Food  Chem. 15:492-496 May/June 1967.

17.   West, I.
         Lindane and hematologic reactions.
         Arch.Environ.Health 15:97-101  July 1967.

18.   Lindgren, D.L., Sinclair, W.B. & Vincent I.E.
         Residues in raw and processed  foods resulting from post-
         harvest insecticidal treatments,  (p.37-39.  Thermal vaporizers.)
         Residue Revs. 21:1-121 1968.

19.   Boyd, E.M. & Chen, C.P-
         Lindane toxicity and protein-deficient  diet.
         Arch.Environ.Health 17:156-163 Aug. 1968.

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20.   Stieglitz.  R.,  Stobbe, H.  & Schuttmann,  W.
         Knochenmarkschaden nach beruflicher  einwirkung des
         insektizids gamma-hexachiorcyclohexan (lindan).
         Acta Haemat.  38:337-350 1967.

21.   Kay, R.W.,  Kuder, G.G., Sessler,  W.M.  &  Lewis,  R.A.
         Fatal  poisoning from ingestion of  benzene
         hexachloride.
         Ghana  Med.  Jour.  3: (2); 72-74  June 1964.

22.   Jedlicka,  V.,  Hermanska, Z.,  Smida,  I. & Kouba,  A.
         Paramyeloblastic  leukaemia  appearing simultaneously
         in two  blood  cousins after  simultaneous  contact with
         gammexane  (hexachlorcyclohexane).
         Acta Med.Scand. 161:447-451  1958.

23.   Norton, R.G.,  Karel,  L. &  Chadwick,  L.E.
         Toxicity of r-benzene  hexachloride in clothing.
         Science 107:246-247 Mar.  5,  1948.

24.   Insecticide vaporizers - help or  hazard?
         JAMA 149:371-372  May 24,  1952.

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APPENDIX 3
In this Section the two days of Committee meeting will be discussed in
order to provide a summation of all data underlying the consensus
reached and the recommendation made.  The Committee utilized the first
day to make certain that all members understood the assignment and to
review and discuss the Exhibits and References (Appendices 1 and 2)
which had been furnished in advance and which pertained to the cancel-
lations at issue.  These Exhibits and References are discussed in the
Section entitled "Review of Health Aspects of Pesticides."  Complete
minutes of both days meeting were recorded by the Secretariat.

The morning meeting of April 28 was attended by representatives of three
of the four companies who had petitioned for the appointment of an
Advisory Committee as is shown in the minutes.  It is necessary to note
that Additional Exhibits were presented to the Committee or received by
the Chairman after the meeting.  For the record these are:

     ADDITIONAL EXHIBITS
     1.  Letter from L.A. McLean to Dr. J.T. Litchfield, Jr., Chairman,
         April 14, 1970, with attached Statement on Behalf of
         Continental Chemiste Corporation.
     2.  Review of Lindane and Lindane Vaporizers, The Lindane Group,
         by F.H. Pretsch April 77, 1970, The Agatha Corporation.
     3.  Statement presented to Lindane Advisory Committee by Thuron
         Industries, April 28, 1970.
     4.  The toxic Hazard Associated with Continuous-flow Heat-
         volatilized Insecticidal and Acaricidal Aerosols.  Baker,
         A.H., et al, Laboratory Practice, 13, 3-11, 1959.

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     5.   Pesticide Residues  as Hazards,  Barnes,  J.M.,  PANS  15,
         2-8, 1969.
     6.   Letter with attachments  from Mitchell  R.  Zavon,  M.D.,
         Agatha Corporation, addressed to  Dr.  J.T.  Litchfield,  Jr.,
         Chairman, May 7,  1970.
     7.   Letter from Dr.  Harry W.  Hays addressed to Dr. J.T.  Litchfield,
         Jr., Chairman, May  8, 1970.
These additional  exhibits were either given  to Committee members  at
the time of the meeting or mailed to them subsequently.   They are
available from Agricultural  Research Service.   The  main  body of the
report will be concerned with the Exhibits and References of Appendices
1  and 2 so that it is necessary to deal  with the  above seven items  at
this point.

The first is a legal  document which when presented  on April  28, was
referred to counsel  for the Department of Agriculture for disposition
since it did not deal with scientific or technical  data  concerning
lindane.  The same is true of Item 3 which was similarly referred.   Item
2 is a well organized review of the literature relating  to lindane  and
lindane vaporizers.   While it adds some additional  references to those
submitted to the Committee it does not affect materially the information
bearing on the crucial issues of safety.  Item 4  concerns a  study made
with continuously operating vaporizers dispensing a mixture  of 60%
lindane and 40% DDT in animal quarters over  a period of  slightly more
than one year.  This study involved exposure of animal attendants as
well as a variety of animals, birds, and insects.  This  item was partic-
ularly cited by industry representatives as  indicative of the safety of

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lindane when used as recommended.  There was no indication of any ill
effect of any kind on the exposed animal attendants, but it should be
noted that the concentrations of insecticides in the air were lethal to
budgerigars in an average of 18 days (range 2-73 days).   Furthermore,
the maximum exposure of an animal attendant in the room  with the highest
concentration of lindane was 206 intermittent hours (5 days/week)  out
of a total of 9144 hours, or 2.25% of the total time period.  This
particular animal attendant was exposed an additional  824 intermittent
hours or 9% of the total time in another room with a concentration of
lindane 70% of that in the first room.   In the case of a continuous
vaporizer in an industrial establishment, a worker could be exposed to
about 24% of total time each week (40/168 hours) which is an order of
magnitude greater.

Item 5 is a general paper on pesticides which mentions only DDT
specifically and does not relate directly to lindane.  Item 6 with
attachments pertains to the insecticidal activity of lindane dispersed
as a one shot fumigation in laboratory tests involving various insects.
These data were submitted because Dr. Zavon had mentioned the need to
prevent encephalitis transmitted by Culex pi pi ens.  Members of the
Committee asked if lindane was effective against this  mosquito and the
answer was not available.  The data submitted in Item 6  do not contain
test against Culex pipiens or any other mosquito.  Finally Item 7 is a
response to the Committee's request for additional information about the
fataltttes tabulated in Exhibit 18.

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In the course of the morning meeting April  28, 1970, the labeling of
several of the affected products was examined.  The Committee expressed
concern about the fact that several  products for fumigation contained a
combination of lindane with other pesticides.   In one case lindane was
combined with DDVP (dichlorovos) and in another with p-dichlorobenzene.
There was apparently no knowledge concerning the joint toxicity which
might result from such a combination and apparently no such toxicity
studies have ever been conducted.  In the afternoon, the Committee
considered the Additional  Exhibits which were  available and concluded
its deliberations.
               /'
John T. Litchfield, Jr.,  M:0.,  Chairman         'Date •'

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     This is to  certify that the Lindane Advisory Committee

     report submitted by the Chairman Dr. John T. Litchfield,

     Jr., on July 2,  1970,  is the report which was approved

     by the Committee.
         s
       ' 11
     William B. Deichmann,  Ph.D.
                             /!
      &mes 'C. Street,  Ph.D.
Michael B. Shimkin,  M.D.
                                       /Batq/r
                                     I/
                                             Date
               c"
Donald G. Crosby,  Ph^.
                                             Date
     The last person to sign should forward to the Secretariat.
, u. s. GOV:
      •ERNMENT PRINTING OFFICE -.1972-484-486/266

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