f/EPA
            United States
            Environmental Protection
            Agency
            Office of Toxic Substances  EPA No. 660/5-SS42S
            Exposure Evaluation Division Oocumcrt No. NHATS-SS-01
            401 M St. SW       Septembt 30.1885
            Washington D.C. 20460
            Toxic Substances
Baseline Estimates and
Time Trends for
Beta-benzene hexachloride,
Hexachlorobenzene, and
Polychlorinated Biphenyls in
Human Adipose Tissue
1970-1983

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t     •-        .......'••.
                                     it

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                              Baseline Estimates and
                                 Time Trends  for
                               6-BHC, BCB  and PCBs
                             in Human Adipose Tissue
                                    1970-1983
                             Document No. NHATS-SS-01
                                   Prepared  by

                                 Gregory A.  Mack
                          BATTELLE COLUMBUS LABORATORIES
                                 505 King Avenue
                              Columbus, Ohio  43201
                                       and
                                  Leyla Mohadjer
                                   WESTAT, INC.
                             1650 Research Boulevard
                           Rocfcville, Maryland  20850
                                September 30, 1985


                             Contract No.  68-01-6721
                  Rich Levy and Janet Remmers,  EPA Task Managers
              Joseph Carra and Joseph  Breen,  EPA Project Officers


i                                   Prepared for


                          Design and Development Branch
                               Field Studies Branch
                           Exposure Evaluation Division
'                    Office of Pesticides  and Toxic Substances
1                      U.S.  Environmental Protection  Agency
                             Washington,  D.C.   20460
                           U.S. Environmental Protection Agency
                           Region 5, Library (PL-12J)
                           77 West Jackson Boulevard, 12th Floor
                           Chicago, IL 60604-3590

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                        TABLE OP CONTENTS
ACKNOWLEDGMENTS   	

PREFACE   	, .

EXECUTIVE SUMMARY   	

1.0  INTRODUCTION   	
     1.1  Background   	
     1.2  Objectives and Scope of the Statistical
          Analysis   	

2.0  DATA COLLECTION AND PREPARATION   	
     2.1  Survey Design	
     2.2  Available Data and Data Preparation   	
          2.2.1  Available Data   	
          2.2.2  Data Preparation   	
     2.3  Sample Weights   	
     2.4  Limitations of Statistical Inference   	

3.0  RESULTS OF THE STATISTICAL ANALYSIS   	
     3.1  Estimates of population Baseline Levels    	
          3.1.1  Population Estimates for B-BHC   	
          3.1.2  Population Estimates for RCB   	
          3.1.3  Population Estimates for PCBs   	
     3.2  Time Trend Analyses   	
          3.2.1  Time Trend Estimates for B-BHC   	
          3.2.2  Time Trend Estimates for RCB   	
          3.2.3  Time Trend Estimates for PCBs   	

4.0  REFERENCES   	


                        LIST  OF APPENDICES


APPENDIX A   	
APPENDIX B	
     B.1  STATISTICAL MODELS   	,
     B.2  APPROACH TO THE TIME TREND MODELING   	
          B.2.1  National Time Trends	
          B.2.2  investigation of Time Trend Differences
                 Across Subpopulations   	,

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ACKNOWLEDGMENTS

     The  authors  would  like  to thank  the EPA  Task  Manager, Mr.
Rich  Levy,  for  his  assistance  in  performing  this  study.    Bis
suggestions and technical  comments were invaluable in producing a
more comprehensive, higher quality statistical analysis.

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                                11
PREFACE

          This  document  is  one  in  a  series  that  collecti'
describes the operation and results of  the  National  Human Adi;
Tissue  Survey   (NHATS).  Each   document  provides -the  comp
details for a particular  aspect  of  the  NRATS  program.  This re;
presents the  results  of a statistical analysis  of baseline le
and  time  trends  for  several   toxic   compounds.   The  anal
addresses the three compounds:  Beta-benzene hexachloride (6-8
hexachlorobenzene (RGB),  and polychlorinated  biphenyls (PCBs)
is based on data collected through fiscal year 1983.
          Other  documents  in   the   NHATS   series  describe
statistical   survey   design,   the    chemical   analysis   and
techniques/ and  other  statistical  analyses  and  special stu
related to NHATS.  (See the  list of documents on  the next page
          References  to the  series  provide  interested  individ
complete information  concerning  the  NHATS program.  Each docu
in the series is being  maintained and updated as modification
the  NHATS  program  requires  it.   Additional  documents  wil]
added as special analyses or studies  are conducted.

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                             Ill
                 Documentation Series  for the
             National Human Adipose Tissue Survey
NHATS-ST-01
NHATS-SD-01
NHATS-SS-01
NHATS-SS-02
NHATS-DM-01
Mack, G.A., and Stanley, J.  "Program Strategy
for the National Human Adipose Tissue Survey",
prepared  by  Battelle's Columbus  Laboratories
and Midwest Research  Institute  for  the  Office
of Toxic  Substances of  the U.S. Environmental
Protection  Agency,  Washington,  D.C.,   20460
(August, 1984).

Mack,  G.A.,   Leczynski,   B.,   Chu,   A.,   and
Monadjer, L.   "Survey Design  for  the National
Human  Adipose  Tissue  Survey",  prepared  by
Battelle's Columbus  Laboratories and  Westat,
Inc.  for  the  Office   of  Toxic  Substances
of  the  U.S.  Environmental  Protection  Agency,
Washington, D.C., 20460 (November, 1984).

Mack,  G.A.,   and  Mohadjer,  L.   "Statistical
Analysis  of  Toxic  Residue  Levels   of  8-BHC,
HCB,  and  PCBs   in   Human  Adipose   Tissue
1970-1983",  prepared  by   Battelle's  Columbus
Laboratories and Westat,  Inc.   for  the Office
of   Toxic  Substances,    U.S.    Environmental
Protection  Agency,  Washington,  D.C.,  20460
(November, 1984).

Leczynski,   B.,   and   Stockrahm,   J.    "An
Evaluation  of  Hexachlorobenzene  Body  Burden
Levels   in   the  General   U.S.  Population",
presented by  Battelle's Columbus Laboratories
for  the  Office of  Toxic  Substances  of  the
U.S.     Environmental    Protection    Agency,
Washington, D.C., 20460 (January, 1985).

•National   Human   Adipose   Tissue   Survey,
Documentation  Manual,  Data  Base  Structures
and   Program   Descriptions",   prepared   by
Battelle's   Columbus   Laboratories   for   the
Office   of   Toxic  Substances  of   the  U.S.
Environmental  Protection  Agency,  Washington,
D.C., 20460 (May, 1985).

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I
I
I
                                       iv

1        EXECUTIVE  SUMMARY

*                  The National Human Adipose  Tissue  Survey (NHATS) is
I        annual program  to collect  and  chemically  analyze  a  nationw
i        sample of adipose  tissue  specimens  for the presence-of  specif
        toxic compounds. The  objective of  the  program is  to detect <
        quantify   the  prevalences  of   toxic   compounds   in  the  gene:
        population.  The specimens are  collected  from autopsied  cadavi
j        and surgical  patients  according to a statistical  survey  desii
        The survey design  ensures that specified geographical  regions  <
        demographic   categories  are  appropriately  represented  to  peri
        valid and precise  estimates of  baseline  levels,  time  trends  .
        comparisons   across  subpopulations.  The NHATS  data  are used
        address  part of  OTS's  mandate  under  TSCA  to  assess  cheraii
        exposure  risk  and  environmental burden to  the  U.S.  populatii
        Since  NHATS  involves   human  monitoring,   it   provides   dir<
        evidence of  exposure  of the  toxic chemicals  to humans.
                  In  order  to  obtain  full  use  of  the  NHATS  progr<
        statistical  analyses are  periodically conducted on the  collec
        data.  This report  presents the analysis results for the  compoui
        beta-benzene  hexachloride  (8-BHC),  hexachlorobenzene (HCB),  i
        polychlorinated  biphenyls (PCBs).   These  compounds were selec
        for this  study  due  to  their  prevalence  and  toxicity  and  th<
        industrial uses which  put  them  under  the  jurisdiction of  TS(
        The analyses  involve  data   collected  through  fiscal year  191
        with  the  results for  1981 and 1983 being  of particular inter*
        since they are  based  on additional  data collected  since the  1<
        statistical  analysis.

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          The major findings of the analysis are as follows:


          B-BHC

          •  The  estimated  1983 national median*  level
             is  0.08  ppm  compared  to  an  historic**
             level of 0.14 ppm.

          •  The  median  levels  tend  to  increase  with
             age but do not differ  across sexes or race
             groups.

          •  The  South   Census  Region has   a  higher
             median   level   than   any   of    the   other
             regions.

          •  The   median   level   has   been   steadily
             decreasing over time  but  the percentage of
             the   population    having   at   least   a
             detectable  level  has  remained  near  100
             percent.
          HCB
             The  estimated 1983  national median  level
             is 0.031 ppm  compared  to  an historic level
             of 0.037 ppm.

             The  levels  do  not  differ  significantly
             across the age, sex and race groups.

             The West Census  Region has  a higher median
             level than any of the other regions.

             Median levels  have  remained relatively the
             same  over  the  past   ten  years  with  the
             exception  of  a  modest estimated  drop  of
             about 0.01 ppm in 1983.   The percentage of
             the   population    having    at    least   a
             detectable level  of HCB has  remained near
             100 percent.
 * Median  level   refers   to  that  value   for   which  half  the
   population have  residue levels exceeding  this value  and half
   have residue levels below it.

** Historic level  refers  to the median  level  computed using data
   for all years for which NHATS data are available.

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t
*                  PCBS
                                       VI
                  •  The  1983   estimated   percentage  of   the
                     population having a  PCB level exceeding  1
                     ppm is 5.5 percent compared  to an historic
                     level of 28.9 percent.

                  •  The   percentage  having   a  PCB   level
                     exceeding 1 ppm increases with age.   Males
                     have a  higher percentage  exceeding  1  ppm
                     than   females.      No   significant    race
                     difference exists.

                  •  The  Northeast Census  Region  historically
                     had  the   greatest  percentage  exceeding  1
                     ppm but  the  difference has  disappeared in
                     recent years.

                  •  The  percentage of  the  population  having
                     PCB  levels  exceeding   1  ppm  is  steadily
                     decreasing   over   time;    however,    the
                     percentage  having  at   least  a  detectable
                     level has increased  to nearly 100 percent.

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'       1.0  INTRODUCTION

'       1.1  Background
I
I                 The National Human Adipose Tissue Survey (NHATSJ is one
        of the  main programs  of the  National Human  Monitoring Program
i
j       (NHMP).  NHMP  is  an ongoing  chemical  monitoring network designed
        to fulfill the human and environmental monitoring mandates of the
        Toxic  Substances  Control  Act  (TSCA).    The  NHMP  was   first
       •established  by the  U.S.  Public  Health Service  in 1967,  and was
        subsequently transferred to EPA  in 1970.  During 1979  the program
       i
        was transferred within EPA to the Exposure Evaluation  Division of
<        the Office of Toxic  Substances  (OTS).
                  The data  for  the National  Human  Adipose Tissue Survey
        are generated on an  annual basis  by  collecting  and chemically
        analyzing  adipose tissue specimens for  selected  toxic  substances,
        historically   organochlorine   compounds   and    polychlorinated
        biphenyls  (PCBs). The  20 compounds that  have  been monitored are
        listed  in  Table 1-1.

                 TABLE 1-1  COMPOUNDS MONITORED IN THE NATIONAL
                          HUMAN  ADIPOSE  TISSUE SURVEY

       £,  £'  -   DDT                               Aldrin
       o,  £'  -   DDT                               Dieldrin
       £,  £'  -   DDE                               Endrin
       o,  £'  -   DDE                               Heptachlor
       £,  £'  -   DDD                               Heptachlor epoxide
       o,  £'  -   DDD                               PCBs
       a  -  BHC                              '      Oxychlordane
        6  -  BHC                              '       Mirex
       Y  -  BBC  (Lindane)                           trans-Nonachlor
        6  -  BHC                                     Hexachlorobenzene

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I
                  The  adipose  tissue  specimens  are  obtained   fron
I        statistically selected sample of  surgical patients and autops
•        cadavers.  Selected pathologists and medical examiners collect
,        tissue specimens on a continuing basis throughout  the fiscal j
i        along with  a  limited amount  of demographic,  occupational,
        medical  information on the individual.
1                  Statistical analyses are  periodically conducted on
        collected   data.   The   analyses    provide   updated   informal
        concerning baseline  levels  of  the  toxic  residues in  the I
        population and  provide  evidence of  any  changes  in tine  trer
        This report  presents  the results of  the most  recent  statist:
        analysis for  the  compounds: 6-8HC,  HCB, and  PCBs. The  anal]
        were  conducted  during   the  summer  of  1984  and  include
        information  on residue levels through fiscal year  1983.

        1.2  Objectives and Scope of the  Statistical Analysis

                  The purpose of  the NHATS  program  is the  detection
        quantification of  the prevalences  of selected  toxic  compounds
        the general  population.  The presence of toxic substances  in
        adipose  tissue  of  the U.S.  population  is an  indication  of tl
        presence  in   the   environment.   By   selecting   and   chemici
        analyzing  the  tissues of  a representative sample  of individu.
i        information  is  gathered  concerning  existing toxic  residue le1
        in   the  U.S.   population  and  its   various  subpopulations.
        specific objectives of the NHATS  program  are:
i
                  1.   To   assess   the   prevalences  of   toxic
                      substances   in  the  adipose  tissue of the
*                      U.S.  population
i                  2.   To  establish  baseline  levels  for  these
                      compounds  in adipose tissue
                  3.   To measure  time trends  of these concen-
                      trations,  and
                  4.   To   assess   the  effects   of   regulatory
                      actions.

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          These  objectives  are  addressed  by statistically analyz-

 ing  the collected data. The analyses include:


          •  Estimation    of    percentages   of    the
             population   having   detectable   residue
             levels   or   levels  exceeding   specified
             values;

          •  Estimation  of average  residue  levels  for
             the entire  nation and  for  various  subpop-
             ulations   involving   geographic   (census
             regions)  and  demographic  (age,  sex,  and
             race) categories;

          •  Estimation  of  trends  to  assess  changes
             over  time  in  various  population  residue
             level characteristics such as:

                average residue level

             -  median level

             -  percentage  of  population having  detect-
                able residue levels

                percentages of  the  population exceeding
                various specified levels

          •  Regression analyses to  assess differences
             in   the   trends    across    the   various
             geographic and demographic subpopulations.


          The specific data used  in  the  analyses are described in

the next  section along with information  concerning  their collec-

tion and preparation.
                                                              7

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       2.0  DATA COLLECTION AND PREPARATION

       2.1  Survey Design
i                 The  NHATS  program  uses  a  statistical  .based  sur
       sampling  design  to  obtain  adipose   tissue   specimens   from
]       national sample of  autopsied  cadavers  and  surgical patients.   '
       use of  a statistical  design provides for control  of  the  possil
       estimation  errors    due  to  sampling  only  a  portion  of
       population of  interest.  The  use of a statistical design  alL
       the magnitudes  of the sampling  errors to be quantified  and t
       used  to  calculate bounds on  the likely errors  (standard erro
       associated with  the population  residue level estimates  that <
       made.
                 The target population  for  this study  corresponds to
       set of  all  non-institutionalized individuals in  the contermim
       U.S.   However,  due to  the  invasive nature  of  collecting adip
       tissue  samples,  the  sampling population  is limited  to  cadav<
       and surgical  patients.    The sampling procedure  used  to addr<
       this  population  is  a  complex  multi-stage  process.    The
       conterminous  states  are  stratified into  the  nine D..S.   cen
       divisions  (Refer  to the  U.S. map given  in  Figure 2-1).   Hit:
       each  census  division,  population  centers  (ie.    SKSAs- stand
       metropolitan statistical  areas)  are  selected  with probabilit
       proportional  to  their  respective  populations.    The number
       SNSAs  selected  from  each  census  division  is  determined  by
       division's  total  SMS A  population  relative  to   the   total  SI
       population of  the entire  U.S.   Within each selected  SMSA one
       more  hospitals and/or  associated  pathologists/medical examine
       are identified and asked to  contribute tissue specimens accord
       to  design  specifications   involving  age,   sex,  and  race.    '
       categories considered are:

                 •  Age group (0-14 years,  15-44 years,   45* years)
                 •  sex  (male, female)
                 •  race (white, non-white).

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The design  specifications  are  based  on  the  corresponding age,
and race  U.S.  census population figures  for  the census  divis
to  which  the  SMSA  belongs.  The  actual  specimens are  otherv
selected in a non-probabilistic manner  according  to  the  judgem
of the pathologists/medical examiners involved.
          An  overview  of  the  sampling  stages   is  presented
Figure  2-2. The  geographic  stratification  used in  the  dec
ensures a representative sample  from all regions of  the count
Design specifications for  the  age, sex  and  race  categories en*
the proper  representation  for each  of  these  different  subp
ulations.  A detailed  description of  the current  survey design
be found in Mack et. al. (5).
          Although  the  actual  survey design  uses census divis
as  the  stratification  variable, geographical comparisons  in
statistical   analyses   are   based   on    census  regions   (
Figure 2-1). The  use of census regions  in the  analysis  redu
the number  of subpopulation  comparisons and reduces  the degr
of-freedom  needed   for  model  fitting.    No  additional  techni
problems  are  introduced  and   all  results  remain  statistica
valid.

2.2  Available Data and Data Preparation

2.2.1  Available Data

          The  amount of  data  used   in the  statistical  analy
varied  for  the three compounds of  interest  due to  missing d
and various  problems encountered during  the  earlier years of
NBATS  program.  Table  2-1  summarizes  the  specific  years
numbers  of   specimens   available   for   the   analysis  for  e
compound.
          The data  for  1981  and 1983 correspond  to only a port
of the  specimens  actually  collected.    For each  of  these
years,  subsamples   of   specimens   were  selected  and  chemica
analyzed so  that some  information would be  available as quic
as  possible concerning existing  residue   levels.  Each  subsam;

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     Stratify by
    Geographical
       Region
   Nine Census Divisions
 Select Probability
   Sample  of SNSAs
 Within Bach Region
    Two to Seven SMSAs
    Within Bach Region
    Select One  or
   More Hospitals
   Prom Each SMSA
     Approximately 40
       Hospitals  in
       Total  Survey
  Select Specimens
.According  to Design
Specifications Based
On Age, Sex and Race
Approximately 1,000 - 1,500
 Specimens in Annual Survey
  Pigore 2.2.   Overview of the annual selection process
                                                          7

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             TABLE 2-1.   SUMMARY OF DATA USED IN THE

                   ANALYSES FOR EACH COMPOUND
Fiscal Year
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
B-BHC
1403
1587
1993
1186
1025
895
778
926
948
910
--
402
--
200
HCB
•» • mt
~
—
--
1025
895
777
927
947
908
--
402
--
200
PCBs
^—
..
1826
1183
1025
895
779
927
951
910
--
402
--
200
corresponded to  a  representative sample of  the  entire collec
of  that  year's  specimens.     Additional   subsamples  are  to
analyzed  as  money   and   time  permit.  The   fiscal   year
data included   in   this  study   correspond  to   three   sepa
subsamples while  the  1983   data correspond  to  two  subsamp
Since  the sample  size affects  the  size  of  the  standard e
associated with a  population estimate,  estimates  for   1981
1983 tend to have larger error bounds associated with  them.

2.2.2  Data Preparation

          Due  to  the  nature  of the  chemical  analysis  proo
there txists  a   threshold  value below  which  the  chemist  ca
accurately quantify  the  residue level  of  a target  compound  :
given specimen.    This   threshold    is   called   the   level
quantification  (LOQ).   Below   the   LOQ   there  exists    ano
threshold called  the  level  of  detection   (LOD)  below which
chemist  cannot  even declare  that the presence  of the compoum
detected. Values below the  LOD are  recorded  as  "not detect*

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Measured  values  between the LOD and  LOQ are called trace values.
Trace  values indicate  the  target  compound has been  detected but
at  a level  below  which an accurate determination  can  be made of
the  specific amount.   See  Table B.I in Appendix B for approximate
values  of the LOD and LOQ  for  each of the compounds  addrefsed in
this study.
           In the  statistical analyses, residue values reported as
being  below  the  LOD  ("not detected")  were set  equal  to  zero.
Trace  values for  a given  compound and fiscal year  were all set
equal  to  the minimum positive  residue  value,   above  the  LOD,
reported  for  that year.
           The  residue  data were  also  adjusted  for   the percent
lipid   content   of    the   associated    tissue    specimen.   The
adjustment formula  used is  as follows:

                            Unadjusted Level    ,nn.
          Adjusted  Level -      % Lipid       *  xuu*

Since  the chemicals  addressed  in  the  report  tend to be located
only in the  lipid  portion  of the tissue, the adjustment makes the
observed  residue  levels  more   comparable  across tissue samples
having varying  levels of percent  lipid.  The statistical  analyses
excluded  any  specimens having less than 10 percent lipid  content.
Such specimens do  not permit precise  determinations to be made of
the actual residue  level.
           In  some  of  the  statistical  analyses  the data  were
transformed  by  taking  logarithms  of  the  original  data.  In  those
cases  where  the original  data value  was zero  (e.g., no analyte
was  detected),  a  small   positive  number  (e.g.,   .0005   ppm),
representing  a value  between  zero and the LOD,  was  substituted
for zero.  Any resulting bias  is  expected to  be negligible  since
there were relatively  few such  cases.
          The  data for  PCBs were handled  somewhat   differently.
The  PCB  level  for each  specimen  was  reported  by  the   chemical
analysis labs only  as  belonging to  one of  four  categories:

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I
4                                       10

                 •  Not detected  (below  LOD)
                 •  Detected but  less  than 1 ppm
                 •  Between 1 and 3 ppm
                 •  Greater than  3 ppm.

                 The  PCB  data were categorized due  to  the  nature of
        chemical  analysis  methods  that  made  it difficult  to  obtain
        accurate determination of  the actual amount.
                 Due  to the categorical  nature  of  the reported PCB da
        they  were  not  lipid adjusted  (however,  Lucas  (3)  has shown t
        the  effect  of  not  lipid  adjusting is  inconsequential for PCB
        and  the statistical analyses  did  not  address  the  estimation
        average  levels.   Rather,  estimates wer« made  of  the  populat
        percentages belonging to various  range levels  of interest.

        2.3  Sample Heights

                 Calculation  of   unbiased  estimates  of  regional
        national population  residue  levels and  trends require the use
        weighted  statistical  data.     Individuals  from  some   demograp
        groups  represent  smaller   segments of  the  U.S.  population
        therefore  the   observed   residue  levels  associated   with  t
        deserve  less   weight  when  estimating  population  residue  leve
        Although design specifications are given regarding  the number
        specimens  to   be  collected from  each age,  race, sex and cen
        division  category,  the  NHATS  program  does  not  produce  se
        weighting samples  for several  reasons:

                 •  The   small   sample  sizes  for   each   SMSA
                     (approximately 27  specimens)  do  not  permit
                     the  exact  proportionate  selection of the
                    appropriate  number  of  specimens from  each
                    age,    race,    and    sex    category   and
                    geographical  region;  and
                     Discrepancies  between the actual  number  of
                     samples  collected and  the  design  specifi-
                     cations  for  each  collection  site..

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                                11

          The   weight  assigned   to  each   individual   specimen
 reflects  the  number  of  individuals  in  the  general  population
 represented  by that  specimen.  Various adjustments  are  performed
 so  that the sum  of  the sample weights  for a  given geographical
 region   and   demographic   category   equals  the   corresponding
 population  count  according to  the U.S.  Census.  The weights  for
 1970  through 1972 are based on the  1960  Census;  the 1973 through
 1979  weights are  based on the 1970 Census;  and  the  1981 and 1983
 weights  are  based  on  the  1980  Census.  The  details  of  the
 methodology  used  to  construct  the  sample  weights  are  given  in
 Appendix A of a report by Lucas et.al. (3).

 2.4  Limitations of Statistical Inference

          The  sampling population for the  NHATS program includes
 only surgical patients  and  autopsied  cadavers.   Since the sampled
 population  is  different  from  the  target  population  (i.e.,  the
entire U.S.),  validity of any  inferences requires  the assumption
 that  the  prevalences  and  levels  of  the  toxic   substances  of
 interest are the same  in both populations.
          Other limitations result from  the survey design and its
 implementation.   Since  population   centers  (SMSAs)   form  the
 sampling  frame,  areas  that are  rural in  character  are excluded
 from the sample. A sizable  percent of the U.S.  population resides
 in  these  rural areas.  The  real  percentage  of omission  is most
 likely  somewhat  less,  however,   because  the   service   areas  of
hospitals  in  the  SMSAs  extend   into  neighboring   rural  areas.
Nonetheless, the  urban nature of  the sample does result in some
 undercowrage of the rural population;
          Limitations  also  result  from   the  purposeful  selection
of  the  medical  examiners  and  pathologists  and   the  lack  of
probability  sampling  used  by  them in selecting tissue  specimens
 for the  study.    The  purposeful  selection methods may  result in
biases  in estimates  derived from  the sample.  However,  the biases
are expected to be minimal for several reasons:

-------
                                       12


                  (1)   The  selection of specimens are done on a
                       pseudo-random  basis   without   regard  to
                       Iany   factors   that   are   likely  to  be
                       systematically related to  toxic  residue
                       levels.

!                  (2)   The  specimens  are  screened so that-  the
1                       selected   ones  involve  only   traumatic
                       deaths    and   specific   diseases    not
•                       expected  to  influence  the  toxic  residue
                       levels in the  body.

                  (3)   Target  quotas  control  the  number   of
                       specimens collected with respect to some
                       of  the  most  important   factors:  age,
                       race,  and sex.  Further, deviations from
                       target quotas  are  minimized  by the  use
                       of weights applied to each  specimen when
                       making statistical  estimates.


        Any  remaining  biases are expected  to be  negligible relatii

        the  magnitudes of  the  trends and other subpopulation differ

        that have  been observed.
                  The   chemical  analysis   techniques  employed  over

        years  in the NHATS program  is another potential source  for

        The  analysis  methods  changed at  the end  of  1974.  However

        investigation  by Lucas et.al.  (3)  of  the  possible effects  o:

        change  on  PCS  trends  indicated  that  the  effects   are  inc

        quential.

-------
                                       13

I
        3.0  RESULTS OP THE STATISTICAL ANALYSIS


•                  The  objective  of the NHATS program is the detection and
,        quantification of the prevalences of  selected  toxic chemicals in
        the  U.S.  population.  To  address this  objective  a   statistical
        analysis  was  performed   on   the  collected  data.  The  -analysis
        included:


                  •  Estimation  of  population  residue  levels
                    for  the  purpose  of  establishing  baseline
                    levels;

                  •  Estimation   of   time  trends   to  assess
                    changes  in  residue levels over  time; and

                  •  Comparison  of  various   subpopulations  to
                    identify  geographic   and  demographic  fact-
                    ors  associated   with differences  in  the
                    toxic residue levels.


                  The  results  of these analyses  for the compounds 6-BHC,

       HCB and  PCBs are  described in  the  following  sections.


       3.1  Estimates of Population Baseline  Levels


                  Estimation  of  population  baseline levels  involves the

       calculation   of   various   summary   values   that   characterize
       particular  aspects  of  the  distribution of  residue  levels.  The

       following  population characteristics were estimated:


                  •  Average individual residue  level

                  •  Median (50th  percentile),residue level

                  •  Percentage  of  individuals  having  detecta-
                    ble  levels of the toxic compound

                  •  Percentage  of individuals having quantifi-
                    able levels

                  •  Percentages  of  individuals  having residue
                    levels   exceeding .   specific   values   of
                    interest.

-------
I
I
                                       14
j
                  To provide support  concerning  the reliability of  t
        estimates the following auxiliary information  is  also  given:
I
                  •  standard errors of the  estimates
                  •  sample  sizes used  in the  calculations
                  •  size of the population represented by each
                     estimate.

                  The estimates  were  made  both for  a  single   comb
        population  representing  the  entire   nation,  and   for   var
        subpopulations defined  by  age,  sex,  race,  and geographic  re
        categories.  The estimates were  calculated  in two different  w
        (1)  using combined  data  for all fiscal years; and  (2) separa
        by fiscal year.
                  A  computer  program  called   SESUDAAN  (6)  was  used
        calculate  the  estimates. The  techniques  used by  SESUDAAN
        required  because of the complex  survey design  used  to collect
        sample  specimens. The  results  for  the  three compounds  addre
        in this  report are  presented in the  following sections.

        3.1'. 1  Population Estimates  for 6-BHC

                  Table   3.1-1   presents  estimated   population   res
        levels  for the compound B-BHC.  Estimates are given  separately
        each  subpopulation  as  well  as   for   the  entire   nation.
        estimates are  based on  combined data  for  all  fiscal years
        represent baseline  levels  for  the  presence  of 6-BHC  in  the
        population.  For  the  entire nation the  estimated levels are:

                  •  Average individual residue level—0.27 ppm
                  •  Median residue  level--0.14 ppm

-------
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]                 •  Percent of  the  population  having  detect-
                     able levels  of B-BHC—98.7 percent

I                 •  Percent   of     the    population    having
                     quantifiable    levels   of     B-BHC—92.8
(                    percent.

I
                  The   baseline    levels   vary   across   the  diffe
•       geographic and demographic  groups.  A comparison of these  sub
        ulations indicate:


                  •  AVERAGE B-BHC  LEVELS

                     -  Average levels increase with age*

                        South   Census  Region  has  a   higher
                        average  level than  the   Northeast and
                        North Central regions

                  •  MEDIAN B-BHC LEVELS

                        Levels  increase with age

                        South  Census Region  has a  higher median
                        level  than  all the other  regions

                  •  DETECTABLE LEVELS OF  B-BHC

                     -  There   are   no differences  in  subpop-
                        ulations  with respect to  the  percentage
                        of  individuals having detectable levels
                        of  B-BHC

                  •  QUANTIFIABLE LEVELS OF B-BHC

                     -  The "0-14  yrs" age  group  has  a lower
                        percentage     of    individuals    having
                        quantifiable  levels  of  B-BHC;  no other
                        differences exist  among subpopulations
        *A  difference  in  levels  was  declared  whenever  individual
         confidence intervals for the true average  levels  for  two or i
         subpopulations were  non-overlapping.

-------
                                17

          Tables  A.I -  A. 12 in  Appendix  A present  the baseline
estimates  separately  for  each   fiscal  year.   Comparison of  the
subpopulations  separately for  each fiscal year indicates the sane
general  results as  obtained for  the combined data.  The  increasing
trend  in B-BHC  levels vith  age  group tends to hold for each year.
Similarly,  the  South Census Region consistently had  much higher
average  levels  than the  others.  Although  the differences  are
often  not  statistically significant  for  a given  year  (due  to
smaller  sample  sizes),  the differences  are meaningful since they
consistently occur  over  the different years.
          Tables  A. 11  and  A. 12  for  fiscal years 1981  and 1983,
respectively,   show  that  the  baseline   levels  for  the  median
residue  amounts have decreased  relative  to earlier  years. Table
3.1-2 on the next page summarizes  the differences.

3.1.2  Population Estimates for BCB

          Table  3.1-3  presents  the  baseline  estimates for HCB.
The  estimates   are  based  on  the combined data  for  all  fiscal
years.   The  estimated  baseline  levels  for  the  nation  are  as
follows:

          •  Average  individual   residue   level—0.053
             ppm
          •  Median  (50th  percentile)   residue  level—
             0.037 ppm
          e  Percentage   of   the   population   having
             detectable  levels of HCB--98.8 percent
          e  Percentage   having   quantifiable   levels—
             92.9 percent.

-------
                               18
    TABLE 3.1-2.
COMPARISON OF 6-BHC BASELINE MEDIAN LEVELS 1
FOR 1981 AND 1983 AGAINST ALL TEARS COMBINE!
Estimated Median Residue Level*
All Years
Subpopulation Combined 1981 1983
Age (in years):
0-14
15-44
45+
Sex:
Male
Female
Race:
White
Non-White
Census Region:
Northeast
North Central
South
West
Entire Nation

.08
.14
.26

.14
.15

.14
.16

.13
.12
.21
.12
.14

.05
.08
.18

.08
.11

.09
.12

.07
.09
.14
.06
.09

.06
.06
.17

.08
.09

.08
.08

.07
.07
.13
.06
.08
*parts per million, adjusted for lipid content of specimen

-------
                                                 19
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'                                       20
                  Comparison  of  the  residue  levels  across  the  sub]
        ulations indicates the following results:
                  •  AVERAGE HCB LEVELS
I
I                     -  No age, sex or race differences  exis.£

I                     -  West Census Region has a higher  average
!                        level  than  the  North Central and  South
                        regions

j                  •  MEDIAN HCB LEVELS

                     •  "0-14 yrs" age group has a  lover median
                        level  than  the  older  age  groups;  no
                        other  age,   sex   or   race   differences
                        exist

                     -  West Census  Region has a  significantly
                        higher  median   than  all   the   other
                        regions

                  •  DETECTABLE LEVELS OF HCB

                     -  No differences  exist among  any of  the
                        subpopulations

                  •  QUANTIFIABLE LEVELS OF HCB

                     -  The  "0-14  yrs"  age  group  has  a  much
                        lower percentage than the  older  groups;
                        no  other  age,  sex,  race   or  census
                        region differences exist.


                  Tables  A. 13   through  A. 20  in  Appendix   A  present
        baseline  estimates   separately   for   each   fiscal   year.
I        differences among  subpopulations  are generally  not statistic
        significant  and  not  always  consistent  in  trend.  However,

        appears  that  some meaningful  differences  do exist since  cer

        differences tend  to  be present for many of the years.   The

        Region has much  higher HCB levels than the  others; and  the "

        years"  age  group has  lower  percentages   of  individuals  ha

        quantifiable levels.

-------
                                       21


                  Table 3.1-4  presents a comparison of median RGB  levels

 I       for  1981  and  1983,   respectively,  against  the  overall  median
 *       calculated  using  data  for  all  years  combined.    The values  for
        11983  show  a  decline  in  HCB  levels  relative  to  the  levels
        calculated  for  all years  and also  relative to  the 1981  levels

        alone.
 *                                                                   •

        3.1.3  Population Estimates for PCBs
 i
 \
                  Since only categorical data  are  available  for  PCBs,  the

        statistical  analyses  were  directed   at   estimating  population
        percentages  falling  into  various  residue range  levels.    Table
        3.1-5 presents  these   results  for  the  range  levels  of  interest.
        The estimated national baseline percentages are as follows:


                  •  Percentage   of   the   population   having
                     detectable levels of PCBs — 95.3 percent

                  •  Percentage having levels exceeding 1 ppm
                     -- 28.9  percent

                  e  Percentage having levels exceeding 3 ppm
                     -- 5.1 percent


1                  Comparison   of  results  across   subpopulations  indicate

        the following:

i
                  •  PERCENTAGE HAVING DETECTABLE LEVELS

I                     -  The "0-14 yrs"  age group  has  a smaller
                        percentage  having  detectable levels of
.                        PCBs

                  •  PERCENTAGE EXCEEDING 1 PPM

|                     -  The "0-14 yrs"  age group  has  a smaller
                        percentage   of   individuals   exceeding
                        1 ppm
I
                     -  Males   have    a   higher   percentage
                        exceeding 1 ppm than females
                                                                     ,L

-------
                               22
       TABLE 3.1-4.   COMPARISON OF HCB MEDIAN LEVELS  FOR 1981
                     AND 1983 AGAINST ALL TEARS COMBINED
Estimated Median Residue Level*
All Years
Subpopulation Combined 1981 1983*
Age (in years) :
0-14
15-44
454-
Sex:
Male
Female
Race:
White
Non-White
Census Region:
Northeast
North Central
South
West
Entire Nation
.030
.039
.042
.039
.035
.037
.033
.036
.033
.030
.063
.037
.033
.041
.050
.043
.040
.041
.044
.036
.040
.038
.059
.041
.028
.029
.037
.034
.028
.031
.031
.031
.032
.024
.044
.031
*parts per million,  adjusted for lipid content of specimen

-------
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                                       24
                  •   PERCENTAGE  EXCEEDING  3 PPM
                     -   The  "0-14 yrs" age group has a smaller
                        percentage  of  individuals  exceeding  3
                        ppm
I
i                     -   The  percentage of non-whites exceeding
                        3  ppm  is greater  than the percentage of
                        uV J k A mt
                     -  Northeast  Census  Region has  a greater
                       percentage  of  individuals  exceeding  3
                       ppm  than all  the other  regions.

                 Baseline   data   for   the   individual   fiscal  years  a
        presented  in  Tables  A. 21 through  A.30.  The  trends  previous
        cited  generally  hold  for  the  individual  years  as  well.  T
        percentages  of  individuals having PCB  levels exceeding 1 ppm a
        consistently  smaller   for  the  "0-14   years"   age  group.  Mai
        consistently  had  greater  percentages  exceeding  1  ppm  than d
        females.  The  Northeast  Census  Region  historically   had   high
        percentages  exceeding  both 1  and  3  ppm; however, in recent yea
        this   difference   has   disappeared.      Non-whites   had  great
        percentages exceeding  3 ppm than did whites.
                 The  baseline levels  given  in Table  3.1-6 for 1981 i
        1983   indicate   a  considerable  decline   in   the  percentage
        individuals   having   PCB   levels   greater  than   1   ppm.   Th
        corresponds  to a similar drop in  the percentage  of  PCB  leve
        exceeding  3  ppm  cited  in an  earlier  report by Lucas  et.al.  (
        and  confirmed  in this  report by  Tables  A. 29 and A. 30.   Not
        however,  from Tables A.29  and A.30 that the percentage of samp]
        individuals  having  detectable levels of PCBs has  increased  to  ]
        percent  for  the 1981 and 1983  fiscal years.

        3.2  Ti»e Trend Analyses

                 The investigation of  trends  involves the estimation
        changes  in residue  level  distributions  over  time.    Specifica:
        this  involves  the  comparison  over  time  of residue  distribut:

-------
                           25
TABLE 3.1-6.  COMPARISON OP PCB BASELINE LEVELS FOR 1981
                AND 1983  AGAINST ALL TEARS  COMBINED
Estimated Percent Greater than 1 ppm
All Tears
Subpopulation Combined 1981 1983 -
Age (in years):
0-14
15-44
45+
Sex:
Male
Female
Race :
White
Non-White
Census Region:
Northeast
North Central
South
West
Entire Nation
12.3
32.2
39.3
32.9
25.1
28.4
32.4
37.1
26.5
27.2
24.8
28.9
12.1
16.1
23.7
17.7
17.4
15.0
31.5
12.2
18.9
17.8
21.3
17.5
3.1
3.6
9.9
10.9
0.3
6.0
1.9
2.4
10.2
4.9
3.5
5.5

-------
I
                                       26
t
        characteristics.   Since   the  distribution  of  individual   residi
I        levels is skewed,  it  is useful to address  a number of differei
1        distribution characteristics  to  adequately  describe  the   chang<
        in residue levels.
                  The  population   average   amount  and   median   (50
        percentile)   are   both   measures   of   central   tendency   th
'        characterize  the  "typical"   residue   level.  The   percentage
t
        detectable   levels  and   percentage   of   quantifiable    leve
        characterize the prevalences of  a  toxic compound while the  upp
        percentiles  of  a  distribution characterize  the extreme  values.
                  The  estimation  of  time   trends   and  their  differenc
        across geographic and  demographic subpopulations are based  on t
        use  of a  statistical model.  The  model expresses the assumed fo
        of  the   relationship  between  the   residue  level   characterist
        under  investigation and  the  temporal, geographic  and  deraograph
        factors  of  interest.    Details concerning  the  various  forms
        models used  in  this study are given in Appendix  8.
                  This  report  presents estimates of  national trends  for
        variety  of  different  population  characteristics.    The  natior
        trends   represent   weighted   averages    over    the   differe
        subpopulations  to  give  a  single  estimated  trend  for  the  enti
        U.S.
                  This   report   also   presents  separate  trends   for  t
        individual   subpopulations.      The    subpopulation  trends   i
        presented only  for two  population characteristics considered
        be the most  important  and meaningful:  percentage   of  individue
        having detectable  levels  and the median levels.   For  statistic
        reasons  the  median was considered  to  be more appropriate  than 1
        average  level.   The skewness  of  the residue distribution ma)
        the  statistical  analysis more  valid   when  based  on averages
        log-transformed data,  which  then  correspond  to  an analysis
        medians  when transformed back to  the  original data  scale  (ppm).
                  The  following  sections  present  a summary of the ma;
        results  for  each of the  three  compounds of  interest:  6-BHC, H<
        and  PCBs.  The  effects  of  the  fiscal  years  1981 and 1983  on

-------
29
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                                27

estimated  trends  are of  particular interest  since  the data  for
these years  have  been  updated  to  include  additional  information
since the  last  statistical analysis of the NHATS data.

3.2.1  Tiae Trend Estimates for 0-BBC

           Plots  of  national  time  trend  estimates  for  6-BHC  are
given  in  Figures  3.2-1 through  3.2-4  for  the  different  residue
distribution  characteristics  of  interest.  The  estimated  trend
given in each figure is represented by the dashed line  while  the
•olid lines  represent 95 percent  confidence bands  for the trend.
The  individual  plotted  points   correspond  to  point  estimates
computed  separately  from  the  data for  each   fiscal  year.   The
points  provide  a  comparison  of  how  well the  estimated  trend
describes  the actual changes  in  levels across  the  fiscal years.
The national  trends  for 6-BHC indicate the following:

           •  The   percentage   of   individuals   having
             detectable  levels  of  6-BHC  has  remained
              fairly  constant near  100 percent
           •  The   percentage   of   individuals   having
             quantifiable levels  is decreasing
           •  The  average  6-BHC level  is  declining from
             an estimated  level of 0.45 ppm  in 1970  to
             about 0.16 since 1981
           •  The  median level  is also estimated  to  be
             decreasing

           Summarizing  the  results  for  the  national   trends,  it
appears  that  the  percentage of  the population having  at  least a
detectable level   of  6-BHC   is   remaining   near   100 -percent.
However,  the actual levels  of  e-BHC  are  decreasing.    Further
information   concerning   the   estimated   model  coefficients  and
associated significance levels  are given  in Table  B.2  in Appendix
B.

-------
                                         28
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                                       32
I
I
                 Figures   3.2-5   through   3.2-8  present  the  estimated
        trends    for    the    different   demographic    and    geographic
        subpopulations   for   the   percentage   of    individuals   having
        detectable  levels  of  g-BRC.   Figures 3.2-9 through 3.2-12 present
)        the  trend estimates  for  the median level of  B-BHC.  The plotted
        trends correspond  to  predicted  values generated from  statistical
!        models described in Table B.8.  For  further details concerning how
        the  trend plots  were  generated, see  Appendix B.
.                 For  the  percentage  of   individuals having  detectable
        levels  of  B-BHC the comparison  of  trends  across  the  different
        subpopulations  reveal there  are  no practical differences.   The
        only  statistical differences  involve the absolute  levels across
        the  age  groups;  there   are  no  statistically  significant   trenc
        differences.
                 Analysis  of  trends  for   the   median   level  of   8-BHC
        indicate  the following results:

                 •  The    time    trends    are   significantly
                    different  across  the   age   groups.    The
                    medians  are  declining   for   all  three age
                    groups,  however,  the  youngest  age  group
                    has  declined  less since  the  levels were
                    already  lower than the  other  older groups.
                 •  There  is no  significant difference   in the
                    time  trends  or  the absolute  levels  between
                    the two  race  groups
                 •  There  is no  significant difference   in the
                    time  trends   between  sexes but  there is a
                    difference  in  the absolute  level  between
                    sexes   (females  tend   to   have  slightly
                    higher  levels)
                 •  There  are  no  significant  differences  in
                    time  trends  among the  four census regions;
                    however,   there  are   differences   in  the
                    absolute levels   among  the  regions.  The
                    South  Region  has  the  highest  levels.

-------
33





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                                       41
!
        3.2.2   Time  Trend  Estimates  for HCB

•                 Plots  of national estimates of  time  trends,  95 percent
.       confidence  bands,  and  individual point  estimates  for  HCB  are
j       given   in  Figures  3.2-13  through  3.2-16  for  several  population
        residue characteristics.  The  results  indicate:

                  •   The   percentage   of   individuals  having
                     detectable  levels of HCB has remained near
                     100 percent
                  •   There  is  no  signficant   trend   in  the
                     percentage  of  individuals having quanti-
                     fiable levels
                  e   The  trends  for  both the  average and median
                     levels  of  HCB  indicate a  statistically
                     significant  quadratic trend;  however, the
                     actual changes  in levels are minimal with
                     the  exception   of  about   a .01  ppm drop in
                     1983.

                  Summarizing  the national trends for  HCB, the prevalence
       of  RCB  in the  population  is  remaining  near 100  percent and the
       actual   levels  have   remained  relatively  constant   with  the
       exception  of a drop in 1983. Information concerning the  estimated
       model  coefficients and  the associated  statistical  significance
       levels  are given in Table B.3  in  Appendix  B.
                  Figures  3.2-17  through  3.2-20  present the   estimated
       time trends  for the different demographic  and geographic groups
       for  the percentage of individuals having  detectable  RCB levels.
       Figures 3.2-21 through  3.2-24 present  the estimated  trends for
       the  median  levels. The  statistical  models  used  to  estimate the
       trends  presented  in these figures  are described  in Table  B.9  in
       Appendix B.
                  The  comparison of  RCB  trends  indicate  there are  no
       significant  differences  among  any  of  the subpopulations   with
       respect  to the  percentage  of  individuals having detectable levels
       of  HCB.  For   the median  levels,  comparison  of  the subpopulations
       indicates  the following results:

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                                        42
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                                       54

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          •  The  time  trends are   different  across the
             age  groups;   the   "0-14   yrs"   age  group
             levels have  remained  fairly constant while
             the  other  groups (particularly  the oldest
             group)  had  elevated  levels  for  several
             years during the late seventies

          •  There is no  significant  difference  in time
             trends or  absolute  levels  between  the two
             race groups

          •  There is no  significant  difference  in time
             trends  between  the  sexes;  however,  there
             is  a  difference in   the   absolute  levels
             (males have higher levels)

          •  There  are  no  significant  differences  in
             time  trends  across  the  census  regions;
             however,   there   are   differences  in  the
             absolute  levels.  The  West Region  has the
             highest levels.


3.2.3  Time Trend Estimates for PCBs


          Since  the data  for  PCBs  indicate only the residue leve

range  to  which a  tissue  specimen  belongs, the  results presente

here  correspond  to  the   population   percentages   of   individual

estimated to have PCB levels exceeding  specific values.

          An earlier  NHATS  report by  Lucas  et.al  (3) indicate

that  the  estimated  population  percentage  of  individuals havin
total  PCB levels  greater  than  3  ppm  had  fallen to  near zero
Figure 3.2-25  indicates that  additional data  collected since the

also confirms  this  finding. The emphasis in  this study therefor
involved  the estimation of   the percentage of individuals havin
PCB  levels  greater  than  1  ppm.    Figure  3.2-26 presents   th

estimated trend  for the percentage of  PCB levels exceeding 1 ppm

This  indicates a significant decreasing trend  from a high valu

near 50 percent  in 1972 to a  low value  near 9 percent  in 1983.

          Although the  PCB amounts are decreasing, the percentag

of  individuals having  detectable   levels  is   increasing  up  to

1983 value near  100 percent.  Figure 3.2-27 presents a plot of  th

estimated  time  trend  for  the  percentage  of  individuals havir

-------
                                         55
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                                       58


       detectable PCS  levels.  Information concerning the estimated trenc

       model  coefficients and  their  associated  significance  levels  ii
       presented in Table B.4 in Appendix B.
                 Figures  3.2-28  through   3.2-31  present  the  estimate<

       trends  for  "percent  detected" across  the  different  d*mographi<
       and   geographic   subpopulations.    These    comparisons   indicate
       significant trend  differences  only  across  the age groups.  The "0
       14  years" group has  generally had  lower  levels  but  a  greate
       increasing trend.

                 Figures  3.2-32  through   3.2-35  present  the  estimate
       trend  comparisons  for  the  percentage  of  individuals  having PC
       levels  greater  than  1  ppm.    Comparison  of  the  subpopulation
       indicate the following results:
                                                    «

                 •  There  are  significant  differences  in time
                    trends  across   the age  groups;  the  trend
                    for  the  "0-14 yrs"  age group  leveled off
                    during   the   late  seventies.   The   sharp
                    increase  in  trend indicated in Figure 3.2-
                    32  for the  recent years is an  artifact due
                    to  the   curve   fitting  for   the   earlier
                    years.   Such an  increase  is  not  indicated
                    in  the actual data for  these years.

                 •  There  is   no   significant  difference   in
                    trends  between  the  race  groups;  however,
                    there  is a  difference  in  absolute levels
                    (non-whites have  higher  levels)

                 •  There  is  no  significant difference  in time .
                    trends  between  the  sexes;  however,  there
                    is  a  difference  in absolute  levels (males
                    have  higher levels)

                 •  There  are  no  significant differences   in
                    time  trends  across   the   census  regions;
                    however,   there   are   differences   in  the
                    absolute  levels.  The  Northeast Region has
                    the highest levels.


                 Figures  3.2-36  through  3.2-39 present  the comparison  <

       trends    across   the   various    demographic   and    geograph

       subpopulations   for   the  percentage  of  individuals   having F

       levels exceeding 3 ppm.  The  results  indicate the following:

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There  are  trend differences  among  the age
groups;  the  levels  for  the  "0-14  yrs"
group  have  always  been low while the other
groups   had   elevated   levels  during  the
middle  and  late seventies.   Following the
passage   of   regulations   limiting   the
production  of PCBs, the  levels  have since
declined so that  all  age groups  now have
very few individuals with levels exceeding
3 ppm.

There   is   no   trend   difference  between
whites  and  nonwhites.   However,  non-whites
have higher absolute levels.

There  is no trend  difference between males
and  females.    However, males have higher
absolute levels.

There   are   trend   differences  among  the
different  census   regions;  the  Northeast
Census  Region had  a much larger percentage
of  individuals  exceeding  3  ppm   in  the
middle    seventies.    since    the    PCB
regulations  have been  enacted,  the  levels
have  since  declined  to  the  point where
very few individuals have levels exceeding
3 ppm.

-------
                                72


4.0  REFERENCES


(1)  Bolt  MM  1977.    SURREGR:  Standard  errors  of  regressi
          coefficients from  sample  survey  data.  Research friang
          Institute, Research Triangle Park, NC 27709. .  -

(2)  Lucas RM,  Erickson  MD, and  Williams  SR  1980.  PCB Resid
          Levels   in   Human   Adipose   Tissue:   A   Statistic
          Evaluation  by   Racial   Grouping.     Prepared   by  t
          Research  Triangle  Institute  for  the  Office of  Tox
          Substances,  U.S.     Environmental  Protection  Agenc
          Washington, DC EPA/13-79-015.

(3)  Lucas RM, lannaechione  VG, and  Melroy DK  1982.   "Polychl
          rinated Biphenyls  in  Human Adipose  Tissue  and Mother
          Milk."  Report  to the Office of Toxic Substances, U.
          Environmental   Protection  Agency  by  the   Resear
          Triangle  Institute,  Research Triangle Park,.  NC 2770
          RTI/1864/50-03F.

(4)  Lucas RM, Melroy  DK  and  I miner man  FW  1983.  National Adipo
          Tissue Survey Statistical Analysis  File. Report to  t
          Office   of   Toxic   Substances,    U.S.    Environment
          Protection Agency by  the Research  Triangle  Institut
          Research Triangle  Park, NC 27709.  RTI/1789/00-01F.

(5)  Mack  GA,  Leczynski B,  Chu,  A  and Mohadjer,  L 1984.  "Surv
          Design  for  the  National  Human  Adipose Tissue  Survey
          prepared   by  Battelle's   Columbus   Laboratories   a
          Westat, Inc.,  for the Office of Toxic Substances, U.
          Environmental   Protection   Agency,    Washington   D.
          20460.

(6)  Shah  BV  1979.   SESUDAAN:  Standard  errors  program for co:
          puting  of standardized  rates  from  sample  survey dat
          Research  Triangle  Institute,  Research Triangle  Park, 1
          27709.  RTI/1789/00-01F.

(7)  Johnson,  NL and Kotz  S 1980.   "Continuous  Univariate Distr
          butions  - I  Distributions in   Statistics*,  John WiL
          and Sons, New York, NY.

-------
           APPENDIX A






ESTIMATED BASELINE RESIDUE LEVELS




   FOR INDIVIDUAL FISCAL TEARS

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              APPENDIX B






STATISTICAL APPROACH TO THE ESTIMATION



      OF  POPULATION  TIKE TRENDS

-------
B.I   STATISTICAL MODELS

                                              «
          The  Analysis  of  time  trends  and  their  differences
across  subpopulations  require  the  use  of  statistical  models.   The
model  for  any   given   characteristic  of  the   residue,   level
distribution  expresses  the  functional form  of the  relationship
between  the   characteristic  of  interest   and   the  "predictor

variables"  thought to affect  it:  time (fiscal year),  age,  race,
sex  and geographic region (census region).  The  model provides the

mathematical   framework   needed   to   investigate   and  interpret
observed  relationships  in  the collected  data.  The  assumed  model

includes   unknown   coefficients   (parameters)  whose   values  are
estimated  from  the  observed  data   by  using  linear  regression

techniques. The results  of the regression analysis provide:


           (1)  A  mathematical  equation  that expresses
               the  best  relationship  (of  the  assumed
               model   form)   for   predicting   residue
               levels  as  a  function  of   time  and   the
               geographic         and         demographic
               characteristics   associated   with    the
               given subpopulation.

          (2)  Estimates  of   the  unknown  coefficients
               and   the   magnitudes    of   the  possible
               errors  associated  with these  coefficient
               estimates.  This information   is used   to
               assess  whether  or not a given  factor
               (e.g.,   time,  census   region)   has   a
               statistically   significant  influence   on
               the   population    residue   levels    and
               indicates   the   possible  range   of   its
               influence.


          Due  to  the multi-stage   sampling design  used to collect

the   NRATS  data,   the   regression    analyses  .required  special

adjustments  (e.g.,  implemented  in  the computer  program SURREGR

(1))  to  address   the   correlation   structure   inherent  in  the

collected data.  This  allowed  proper estimates  to  be made for the

standard  errors  of  the coefficients, thus  providing  for  valid

assessments  to be  made  of  the  influence of each factor on the

observed residue levels.

-------
                               B-2

B.2  APPROACH TO THE TIME TREND MODELING

            Two   types   of   trend   models  were   used  in   th
statistical analyses. The first  type  involved  the estimation  of
single  time  trend to represent  the entire  nation with-respect t
the  population residue  distribution  characteristic of  interest
The  second  type   involved  the  investigation  of  differences  i
trends  across  the geographic  and demographic subpopulations.  I
the  following  sections  the  approach  to  modeling  is  discuss*
separately for each type.

B.2.1  National Time Trends

            For each compound  analyzed,  national time trends wei
estimated for  several different  characteristics  of  the populatic
residue level distribution.  For  6-BHC and HCB  these included:

          e  Percentage  of  population having  a detect-
             able level of the compound
          •  Percentage  of  population have a quantifi-
             able level of the compound
          •  Population average  residue amount
          e  Population median

          Since  the  collected data  for  PCBs  were  categorical  :
nature,  different  characteristics  were   addressed  in  the   P<
trends. These were:

          e  Percentage   of   the   population   having
             detectable levels of PCBs
          e  Percentage  of  the  population having  PCB
             levels exceeding 1  ppm, and
          e  Percentage  of  the  population having  PCB
             levels exceeding 3  ppm.

-------
                               B-3


          The  model   used  for  each  compound   and   population

characteristic had the form:


          Y - BQ + BI(FY-FY) + B2(FY-FT)2 + £,            -   (B.I)


where:

          Y   represents   the  observed  value  of  the
          residue  level  characteristic of  interest  for
          a specimen collected  during   the given  fiscal
          year (FY)

          (FY-FY)  denotes the  linear  part of  the time
          trend  centered  at the  midpoint  of  the  study
          period

          (FY-FY)2 represents the quadratic  part  of  the
          time  trend  centered  at the  midpoint of  the
          study period

          BQ,  Bi_ and B2  are unknown  coefficients that
          are  estimated from the observed data, and

          E denotes the  total contribution of  all other
          factors  affecting  the  residue  level  other
          than those included in the model.


          The  definition  of  the  response  variable  Y  depends  on

the  population   characteristic  being  addressed.   The  definitions

for Y are summarized here.


   Population  Average Residue Amount:

            Y « the specimens's observed residue level

   Population  Median:

            Y « Logarithm  (base  10)   of   the  observed
                 residue level
       Note

       The analysis  for  the  median  was  performed  by  estimating
       the average level  for  the  distribution of logarithms (base
       10) of  the  original data  and  then transforming  the result
       into  an   estimate  of    the   median  for   the  original
       distribution (7).

-------
                               B-4


   Population Percentage Raving Detectable Levels:
                 0,  if  the  observed  residue  level  is
                 below  the  level of  detection for  the
                 analytical  measurement  process   (See
                 Table B.I)
             y «
                 1,  if  the observed value is  above  the
                 level of detection

   Population Percentage having quantifiable  levels:

                 0,  if  the  observed  residue  level  is
                 below  the  level of  quantification  for
                 the  analytical  measurement   process
                 (see Table B.I)
             y »
                 1,  if  the observed value is  above  the
                 level of quantification
     TABLE B.I.   APPROXIMATE LEVELS OF DETECTION AND LEVELS OF
                 QUANTIFICATION FOR THE COMPOUNDS &-BHC,
                 HCB,  AND PCBs
          Definition of Value          e-BHC    HCB      PCBs


     Level of Detection* (ppn)         .02      .0033    1.0

     Level of Quantification** (ppm)   .07      .01


 * These values correspond to concentration levels that yield
   signal-to-noise ratios of approximately three.   This implies
   that the probability of declaring detection of a chemical in
   sample that has none is less than 1 percent.

** These values correspond to concentration levels that yield
   signal-to-noise ratios of approximately ten.  This implies
   that the percent relative error in estimating concentrations
   at or greater than this value is 10 percent or less.


          Each  of  the  models  for  the  different characteristi

and  compounds  was  fit  to  the  observed  data using  the  comput

software  called   SURREGR   (1).   The  estimated  values  for  t

coefficients and their  associated  statistical significance leve

are given in Tables B.2 through B.4.

-------
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                               B-8


B.2.2 Investigation of Time Trend Differences Across
Subpopulations


          The  investigation  of  time  trend  differences  aero:

Subpopulations was  limited  to two population  characteristics  f<

B-SRC and RGB:


          •  Percentage   of   the   population   having
             detectable levels of the compound, and

          e  Population median.

For PCBs three characteristics were addressed:

          •  Percentage   of   the   population   having
             detectable levels of PCBs

          •  Percentage  of  the  population  having  PCB
             levels exceeding 1 ppm, and

          •  Percentage  of  the  population  having  PCB
             levels exceeding 3 ppir.

          A complex  statistical model was used  for  each compou

to express  the  residue characteristic  as  a  function of  time  a

the Subpopulations  of  interest.  The form of  the model  is giv

by:


          Y = BO + Bi(FY-FY) * B2(FY-FY)2 + AGE * SEX + RACE + C

             * (FY-FY)*(AGE+RAC£+SEX-K:R)                     (B.

               + (FY-FY)2*(AGE+RACE+SEX+CR),
where:
          Y  represents  the  residue  distribution char-
          acteristic of  interest

          AGE, RACE, SEX and CR denote the main  effects
          due   to   the   different   demographic   and
          geographic Subpopulations

          (FY-FY)*(AGE+RACE+SEX*CR)  denotes  the   inter-
          actions of  the linear part  of  the time trend
          with the different Subpopulations,  and

-------
                               B-9
           (FY-FY)2*(AGE+RACE+SEX+CR)  denotes  the inter-
           actions  of  the quadratic  part  of  the  time
           trend with  the  subpopulations.

The  statistical significance  of  an  interaction  involving  fiscal
year   indicates  that  the  tine  trends  are  different  "fcor  the
associated  subpopulations.     Significance  of  a   main  effect
indicates  a difference  in  absolute  levels across  the subpopula-
tions  associated with  that aain effect.
           The  regression  techniques  used  in  statistical  model
fitting  require  the assumption that  the  distribution of specimen
residue  levels  is  normally  distributed. This assumption, however,
is  more  closely  satisfied  for  the  logarithms  (base 10)  of the
residue  level  data  since  the  actual  residue  distribution  is
skewed.  For this  reason the  comparison of  subpopulation  trends
for  the  median levels of  B-BHC and HC8 were  based on the log-
transformed  data.   The statistical model  (Equation  B.2) was used
to  obtain  trend   estimates  based  on  the  log-transformed  data.
These  trends were  then transformed back  into trend estimates for
the median of the distribution of actual  residue  levels.
          The  results  of fitting  the observed data  to the given
model  are  presented   in  Tables B.5  through B.7.    These  tables
present  the significance  levels  for the  effects  of  each model
corresponding to the different compounds  and  response  variables.
          The  time  trend estimates  and  plots  for  the various
geographic  and demographic  subpopulations were generated by using
predicted  values from a  reduced model  derived  from Equation B.2.
The  reduced model  included  only  the  statistically significant
model  effects  in  Equation  B.2 that  were associated  with  fiscal
year and the geographic  or  demographic  factor  being compared in
the  trend  plot.   For  each  response  variable   and   compound  the
estimated  coefficients for  the reduced  models  are  presented in
Tables B.8 - B.10.

-------
                             B-10
       TABLE B.5.   SIGNIFICANCE LEVELS FOR THE MODEL EFFECTS
                   ASSOCIATED WITH THE COMPARISON OF 0-BBC
                   TRENDS ACROSS SUBPOPDLATIONS
Significance Levels
Effect
Age Group
Race Group
Sex
Census Region
Fiscal Year-Linear
Fiscal Year by Age Group
Interaction
Fiscal Year by Race Group
Interaction
Fiscal Year by Sex Interaction
Fiscal Year by Census Region
Interaction
Fiscal Year-Quadratic
Fiscal Year-Quadratic by Age
Group Interaction
Fiscal Year Quadratic by Race
Group Interaction
Fiscal Tear Quadratic by Sex
Interaction
Fiscal Year Quadratic by Census
Region Interaction
Percent
Detected
Model
.0016
.4551
.2084
.2612
NT***
.1077
.2341
.6562
.3727
NT***
.1033
.2751
.9476
.3880
Average Log*
Amount Model
NT**
.0676
.0416
.0000
NT***
.0002
.3626
.0523
.3628
NT***
.0000
.3798
.7526
.8512
  * Used in the analysis of trends for the median.
 ** The effect is not testable due to the significance of a
    related interaction effect.
*** Not testable doe to the parameterization used to define the
    model.

-------
                              B-ll
        TABLE B.6.
SIGNIFICANCE LEVELS FOR THE MODEL EFFECTS
ASSOCIATED WITH THE COMPARISON OF HCB TRENDS
ACROSS SDBPOPOLATXORS
Effect
Age Group
Race Group
Sex
Census Region
Fiscal Year-Linear
Fiscal Year by Age Group
Interaction
Fiscal Year by Race Group
Interaction
Fiscal Year by Sex Interaction
Fiscal Year by Census Region
Interaction
Fiscal Year-Quadratic
Fiscal Year-Quadratic by Age
Group Interaction
Fiscal Year Quadratic by Race
Group Interaction
Fiscal Year Quadratic by Sex
Interaction
Fiscal Year Quadratic by Census
Region Interaction
Significance Levels"
Percent
Detected Average Log*
Model Amount Model
.0973 NT**
.1181 .8135
.9108 .0006
.0988 .0000
NT*** NT***
.0806 .0010
.1132 .1058
.2360 .5545
.2555 .1250
NT*** NT***
.3413 .0264 •
.0918 .€854
.5965 .7747
.9113 .5852
  * Used in the analysis of trends for the median.
 ** The effect is not testable due to the significance of a
    related interaction effect.
*** Not testable due to the parameterization used to define the
    model.

-------
                             B-12
TABLE B.7.
                   SIGNIFICANCE  LEVELS FOR THE MODEL EFFECTS
                   ASSOCIATED WITH THE COMPARISON OF FCB
                   TRENDS  ACROSS SDBPOPULATIONS
Siqnificance Levels
Percent Percent GT
Detected 1 PPM
Effect Model Model
Age Group
Race Group
Sex
Census Region
Fiscal Year-Linear
Fiscal Year by Age Group
Interaction
Fiscal Year by Race Group
Interaction
Fiscal Year by Sex Interaction
Fiscal Year by Census Region
Interaction
Fiscal Year-Quadratic
Fiscal Year-Quadratic by Age
Group Interaction
Fiscal Tear Quadratic by Race
Group Interaction
Fiscal Tear Quadratic by Sex
Interaction
Fiscal Tear Quadratic by Census
Region Interaction
NT*
.4140
.7548
.8013
NT**
.0346
.1324
.5806
.7610
NT**
.3028
.1B84
.5244
.6265
NT*
.0001
.0002
.0021
NT**
.0018
.5278
.2554
.3210
NT**
.0046
.0730
.6472
.3521
Percent GT
3 PPM
Model
.0000
.0010
.0080
.0029
NT**
.2220
.3324
.5858
.6052
NT**
.0003
.1252
.3227
.0537
 * The effect  of  is not testable due  to  the significance of
   a related interaction effect.
** Not testable  due to  the parameterization  used  to define
   the model.

-------
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-------
HEWT DOCUMENTATION ».,«*>•" «o «.
PAGE 560/5-85-025
Baseline Estimates and Time Trends for Beta-benzene Hexachlorlde
Hexachlorobenzene, and Polychlorinated Blphenyls 1n Human
AH inn, A Ti«u* 1970-1983
Gregory A. Mack* and Ley la Mohadjer2
». NI^KKMH 0*i»ni»t»» turn* •»• tttrun
*Battelle Columbus Division 2ne$tat, Inc.
SOS King Avenue 1650 Research Boulevard
Columbus. Ohio 43201 Rockville, Maryland 20850
U.S. Environmental Protection Agency
Office of Toxic Substances. Design and Development Branch
401 N Street. S.U.
Washinaton, D.C. 20460
«. MHWMTt MMMW, IN
9/30/85 (Date o
•.
NHATSisT-tr
Work Asslgnmer
c, 68-01-6721
«
!&> TfW it •wt A Mn*
Final Report
14.
It AMtrMt (Urn* WO ••*•»)
  The  National  Human Adipose  Tissue  Survey  (NHATS)  1s  an  on-going annual  pr
  collect  and chemically analyze  adipose tissue specimens  from a representative
  sample  of  autopsied  cadavers  and surgical  patients.   The  objective  of  the
  Is  to estimate  baseline  levels and  time  trends  for  the presence of  toxic  <
  In  the  adipose  tissue  of the  U.S.   population.   This  report presents  the re
  a statistical  analysis conducted on three specific chemicals:   Beta-benzene  hexi
  (6-BHC),  hexachlorobenzene  (HCB),  and polychlorinated  biphenyls  (RGBs).   The
  are  based on  NHATS data collected between 1970 and 1983.

  The  results  Include  baseline  estimates  of  the  percentages  of the  populatlo
  detectable  levels  of  these  compounds 1n  their  adipose tissue  as well  as  <
  of  the  mean and median levels.   Estimates  are  given separately for various dei
  groups and  geographic  regions of the country as well as national estimates.

  Results  of  the  analysis  indicate  that  nearly  100   percent of  the  populat
  detectable  levels  of  these  compounds in  their  adipose tissue.   However, tti
  levels of these  compounds are either decreasing or remaining nearly constant.
17. OMvnwM A/i»ir»i»  a. Oncnpur*

    COtATT
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                                                •« «»»«r»«

-------
                              B-ll
        TABLE B.6.
SIGNIFICANCE LEVELS FOR THE MODEL EFFECTS
ASSOCIATED WITH THE COMPARISON OF HCB TRENDS
ACROSS SDBPOPDLATIORS
Effect
Age Group
Race Group
Sex
Census Region
Fiscal Year-Linear
Fiscal Year by Age Group
Interaction
Fiscal Year by Race Group
Interaction
Fiscal Year by Sex Interaction
Fiscal Year by Census Region
Interaction
Fiscal Year-Quadratic
Fiscal Year-Quadratic by Age
Group Interaction
Fiscal Year Quadratic by Race
Group Interaction
Fiscal Year Quadratic by Sex
Interaction
Fiscal Year Quadratic by Census
Region Interaction
Significance Levels"
Percent
Detected Average Log*
Model Amount Model
.0973 ITT**
.1181 .8135
.9108 .0006
.0988 .0000
NT*** NT***
.0806 .0010
.1132 .1058
.2360 .5545
.2555 .1250
NT*** NT***
.3413 .0264 •
.0918 .€854
.5965 .7747
.9113 .5852
  * Used in the analysis of trends for the median.
 ** The effect is not testable due to the significance of a
    related interaction effect.
*** Not testable due to the parameterization used to define the
    model.

-------
                             B-12
TABLE B.7. SIGNIFICANCE LEVELS FOR THE MODEL EFFECTS
ASSOCIATED WITH THE COMPARISON OF PCB
TRENDS ACROSS SUBPOPULATIONS
Siqnificance Levels
Percent Percent GT
Detected 1 PPM
Effect Model Model
Age Group
Race Group
Sex
Census Region
Fiscal Year-Linear
Fiscal Year by Age Group
Interaction
Fiscal Year by Race Group
Interaction
Fiscal Year by Sex Interaction
Fiscal Year by Census Region
Interaction
Fiscal Year-Quadratic
Fiscal Year-Quadratic by Age
Group Interaction
Fiscal Year Quadratic by Race
Group Interaction
Fiscal Tear Quadratic by Sex
Interaction
Fiscal Tear Quadratic by Census
Region Interaction
NT*
.4140
.7548
.8013
NT**
.0346
.1324
.5806
.7610
NT**
.3028
.1884
.5244
.6265
NT*
.0001
.0002
.0021
NT**
.0018
.5278
.2554
.3210
NT**
.0046
.0730
.6472
.3521
Percent GT
3 PPM
Model
.0000
.0010
.0080
.0029
NT**
.2220
.3324
.5858
.6052
NT**
.0003
.1252
.3227
.0537
 * The effect of  is  not testable due  to  the  significance of
   a related interaction effect.
** Not testable  due  to  the  parameterization used  to define
   the model.

-------







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