Methodology for Selecting Chemicals
for the
Voluntary Children's Chemical Evaluation Program
(VCCEP) Pilot
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
December 5, 2000
1
-------
What is the Significance of a Chemical's Beine Identified for the VCCEP?
The identification of chemicals for the Voluntary Children's Chemical Evaluation Program
(VCCEP) was one of the more challenging aspects of the program's development. Both EPA
and some stakeholders agree that available data sources provided limited insight on children's
exposure to chemicals. Consequently, to identify chemicals for the VCCEP, EPA used existing
data sources believed to be especially relevant to children's chemical exposures, such as presence
of the chemical in human tissues and fluids (blood, breath, breast milk, urine) as well as presence
in food and water children eat and drink and in air children breathe. EPA acknowledges that the
chemical identification process does not take into account the unique aspects of children's
potential for exposure, based on their behaviors and activities. For this reason, EPA wishes to
make clear what the list of chemicals selected for the VCCEP represents and what it does not
represent.
Identification for the VCCEP does not mean that the existing hazard and exposure data
have been or will be determined to be inadequate. Nor does it mean that EPA has made or will
make a determination that any uses of the chemical in fact pose significant risks to children's
health. The level of potential risk to children will be determined as part of the VCCEP. The
chemical identification process for the VCCEP did not make this determination.
It is important to note that as part of this program EPA has not made judgements
regarding the adequacy or significance of existing hazard or exposure data for any of the
chemicals selected for the pilot. While EPA recognizes that many of these chemicals are known
to be relatively "data rich," assessment of the adequacy and significance of hazard and exposure
information will be a task of the sponsors participating in the voluntary program. It is also
important to note that for any given chemical in the VCCEP, EPA may ultimately determine that
reasonably anticipated exposures and risks from expected uses do not pose any unique or other
concerns for children's health and safety.
2
-------
How Were Potential Candidate Chemicals for the VCCEP Identified?
After considering the individual comments offered by some of the stakeholders during the
public meetings and in comments submitted to the docket (Refs. 1 and 2), EPA decided to focus
this program on chemicals which have been found to be present as contaminants in:
Human tissues or fluids (e.g., adipose tissue, blood, breath, breast milk, urine)
Food and water children may eat and drink.
Air children may breathe, including residential or school air.
As a first step in the VCCEP chemical selection process, EPA identified chemicals which were
found by biomonitoring data to be present in human tissues or fluids based on data gathered by
the following programs:
National Health and Nutrition Examination Survey III (NHANES III).
National Human Adipose Tissue Survey (NHATS).
National Human Exposure Assessment Survey (NHEXAS).
Total Exposure Assessment Methodology (TEAM).
These programs are described in Appendix I of this document. The biomonitoring data sets
resulting from these programs contain the over 150 chemicals listed in Table 1. Electronic data
files compiled for the Endocrine Disruptor Screening and Testing Program were used as the
starting point for the chemical selection exercise. In general, for this effort, the primary sources
for these data were not reviewed unless issues arose concerning the interpretation of specific data
points in the electronic files. A detailed description of how these data files were developed can be
found in the "Draft Users Guide for the Endocrine Disruptor Priority Setting Database" (Ref. 4)
which can be found at www.epa.gov/scipolv/oscpendo/prioritvsetting/index.
3
-------
Tsihle 1: C'lioiniciils Monitored lor in Soled Miiniiin l$iolo<>ic;il N
oniloriii" IVoijniiiis
CAS No.
( IIIMl( Al. \AMI.
MIA MS
MIAIS
NHEXA
S
I I . A MS
50-29-3
ethane, 1,1,1 -trichloro-2,2-bis(p-chloropheny 1)-
X
50-32-8
benzo(a)pyrene
X
53-19-0
ethane,
2-(o-chlorophenyl)-2-(p-chlorophenyl)-l,l-dichloro-
X
53-70-3
dibenz a,h anthracene
X
56-23-5
carbon tetrachloride
X
56-55-3
benz(a)anthracene
X
57-74-9
chlordane
X
58-89-9
lindane ( Gamma isomer of benzene hexachloride ) (99%
pure gamma
X
60-57-1
1,4:5,8-Dimethanonaphthalene,
X
62-73-7
dichlorvos
X
67-64-1
acetone
X
67-66-3
chloroform
X
X
X
71-43-2
benzene
X
X
X
71-55-6
methyl chloroform
X
X
72-20-8
1,4:5,8-dimethanonaphthalene,
X
72-43-5
methoxychlor
X
72-54-8
DDD
X
72-55-9
ethylene, 1,1 -dichloro-2,2-bis(p-chlorophenyl)-
X
72-56-0
ethane, 2,2-bis(p-ethylphenyl)-l,l-dichloro-
X
75-25-2
tribromomethane
X
75-27-4
bromodichloromethane
X
75-35-4
vinylidenechloride
X
76-44-8
heptachlor
X
77-47-4
hexachlorocyclopentadiene
X
78-59-1
isophorone
X
78-93-3
methyl ethyl ketone
X
79-01-6
trichloroethylene
X
X
79-34-5
1,1,2,2-tetrachloroethane
X
80-56-8
a-pinene
X
82-68-8
pentachloronitrobenzene
X
83-32-9
acenaphthene
X
83-33-0
1-Indanone
X
84-66-2
diethyl phthalate
X1
X
84-74-2
dibutyl phthalate
X1
X
85-01-8
phenanthrene
X
85-68-7
butyl benzyl phthalate
X1
X
86-73-7
fluorene
X
87-40-1
2,4,6-trichloroanisole
X
87-61-6
1,2,3-trichlorobenzene
X
87-68-3
hexachlorobutadiene
X
4
-------
Tsihle 1: C'lioiniciils Monitored lor in Soled Miiniiin l$iolo<>ic;il N
oniloriii" IVoijniiiis
CAS No.
( IIIMl( Al. \AMI.
MIA MS
MIAIS
NHEXA
S
I I . A MS
88-06-2
phenol, 2,4,6-trichloro-
X
90-15-3
1-naphthol
X
90-43-7
o-phenylphenol
X
91-20-3
naphthalene
X
91-22-5
quinoline
X
91-64-5
coumarin
X
92-52-4
biphenyl
X
95-44-3
L-threose
X
95-47-6
o-xylene
X
X
95-50-1
o-dichlorobenzene
X
X
95-63-6
1,2,4-trimethylbenzene
X
95-95-4
phenol, 2,4,5-trichloro-
X
96-12-8
propane, l,2-dibromo-3-chloro-
X
98-82-8
isopropylbenzene
X
100-41-4
ethylbenzene
X
X
100-42-5
styrene
X
X
103-23-1
diethyl hexyl adipate
X
105-05-5
p-diethylbenzene
X
106-42-3
p-xylene
X
106-46-7
p-dichlorobenzene
X
X
X
106-93-4
ethylene dibromide
X
107-06-2
ethylene dichloride
X
108-38-3
m-xylene
X
108-70-3
benzene, 1,3,5-trichloro-
X
108-88-3
toluene
X
X
108-90-7
chlorobenzene
X
X
112-40-3
n-dodecane
X
115-32-2
dicofol
X
115-86-6
phosphoric acid, triphenyl ester
X
115-96-8
ethanol, 2-chloro-, phosphate (3:1)
X
117-81-7
di(2-ethylhexyl)phthalate
X1
X
117-84-0
di-n-octyl phthalate
X1
X
118-74-1
hexachlorobenzene
X
120-82-1
benzene, 1,2,4-trichloro-
X
123-91-1
p-dioxane
X
124-11-8
isononene
X
124-18-5
decane
X
124-48-1
methane, dibromochloro-
X
124-76-5
isoborneol
X
126-72-7
1-propanol, 2,3-dibromo-, phosphate (3:1)
X
126-73-8
tributyl phosphate
X
127-18-4
tetrachloroethylene
X
X
X
5
-------
Tsihle 1: C'lioiniciils Monitored lor in Soled Miiniiin l$iolo<>ic;il N
oniloriii" I'loiii itms
CAS No.
( IIIMl( Al. \AMI.
MIA MS
MIAIS
NHEXA
S
I I . A MS
128-37-0
2,6-di-tert-butyl-p-cresol
X
129-00-0
pyrene
X
131-11-3
dimethyl phthalate
X
132-64-9
dibenzofuran
X
141-93-5
m-diethylbenzene
X
142-92-7
acetic acid, hexyl ester
X
205-99-2
benzo(b)fluoranthene
X
206-44-0
fluoranthene
X
207-08-9
benzo(k)fluoranthene
X
208-96-8
acenaphthalene
X
218-01-9
chrysene
X
309-00-2
1,4:5,8-dimethanonaphthalene,
X
319-84-6
cyclohexane, 1,2,3,4,5,6-hexachloro-, .alpha.-
X
319-85-7
cyclohexane, 1,2,3,4,5,6-hexachloro-, beta-isomer
X
319-86-8
cyclohexane, 1,2,3,4,5,6-hexachloro-, .delta.-
X
333-41-5
diazinon
X
510-15-6
benzilic acid, 4,4'-dichloro-, ethyl ester
X
527-84-4
o-cymene
X
541-73-1
m-dichlorobenzene
X
X
556-67-2
octamethylcyclotetrasiloxane
X
608-93-5
benzene, pentachloro-
X
615-13-4
2-indanone
X
630-20-6
1,1,1,2-tetrachloroethane
X
634-66-2
benzene, 1,2,3,4-tetrachloro-
X
634-90-2
benzene, 1,2,3,5-tetrachloro-
X
789-02-6
ethane,
2-(o-chlorophenyl)-2-(p-chloropheny 1)-1,1,1 -trichloro-
X
933-75-5
phenol, 2,3,6-trichloro-
X
1024-57-3
heptachlorepoxide
X
1120-21-4
undecane
X
1330-20-7
mixed xylene
X
1330-78-5
phosphoric acid, tritolyl ester
X
1746-01-6
dibenzo-p-dioxin, 2,3,7,8-tetrachloro-
X
1825-21-4
anisole, 2,3,4,5,6-pentachloro-
X
1836-75-5
ether, 2,4-dichlorophenyl p-nitrophenyl
X
2021-28-5
hydrocinnamic acid, ethyl ester
X
2051-24-3
decahlorobiphenyl
X
2234-13-1
naphthalene, octachloro-
X
2385-85-5
mirex
X
2847-30-5
pyrazine, 2-methoxy-3-methyl-
X
2921-88-2
chlorphyrifos
X
X
3268-87-9
dibenzo-p-dioxin, 1,2,3,4,6,7,8,9-octachloro-
X
3424-82-6
o.p'-DDE
X
6
-------
Tsihle 1: C'lioiniciils Monitored lor in Soled lliiiiiiin l}iolo»ic;il N
oniloi iii" IVotjniiiis
CAS No.
( IIIMl( Al. \AMI.
MIA MS
MIAIS
NHEXA
S
I I . A MS
5989-27-5
p-mentha-l,8-diene, (R)-(+)-
X
7439-92-1
lead
X
7439-97-6
mercury
X
7440-38-2
arsenic
X
12789-03-6
chlordane
X
23184-66-9
butachlor
X
25323-68-6
trichlorobiphenyl
X
25429-29-2
pentachlorobiphenyl
X
25512-42-9
dichloro-1,1 '-bipheny 1
X
26601-64-9
hexachlorobiphenyl
X
26914-33-0
tetrachlorobiphenyl
X
28553-12-0
diisononyl phthalate
X1
28655-71-2
heptachlorobiphenyl
X
31472-83-0
octachlorobiphenyl
X
33820-53-0
isopropalin
X
34465-46-8
hexachlorodibenzo-p-dioxin
X
35822-46-9
1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin
X
39001-02-0
octachlorodibenzofuran
X
39765-80-5
trans-nonachlor
X
40088-47-9
tetrabromodiphenyl ether
X
40321-76-4
1,2,3,7,8-pentachlorodibenzo-p-dioxin
X
50375-10-5
2,3,6-trichloroanisole
X
51207-31-9
dibenzofuran, 2,3,7,8-tetrachloro-
X
53494-70-5
endrin ketone
X
53742-07-7
nonachloro-1,1' -bipheny 1
X
54135-80-7
1,2,3-trichloro-4-methoxybenzene
X
55684-94-1
hexachlorodibenzofuran
X
57117-31-4
dibenzofuran, 2,3,4,7,8-pentachloro-
X
67562-39-4
dibenzofuran, 1,2,3,4,6,7,8-heptachloro-
X
67708-83-2
dibromochloropropane
X
1 Metabolites of chemicals with this footnote were found in human urine as reported in Ref. 5 which was just recently
published in Oct. 2000. Earlier presentations to Stakeholders did not reflect this new work
7
-------
What Were Some Other Considerations Used When EPA Identified Potential Candidate
Chemicals?
EPA removed chemicals contained in Table 1 from consideration as candidates for
VCCEP if:
They are not chemicals produced in or imported into the United States in an
amount sufficient to meet TSCA Inventory Update Rule (IUR) reporting criteria
for the 1998 reporting period.
They are chemicals being phased out under the Montreal Protocol.
They are chemicals whose risks to children are believed by EPA to be adequately
managed by other ongoing programs.
Further evaluation of the biomonitoring data indicated that the chemical was
monitored for but not detected
The chemicals listed in Table 2 are the Table 1 chemicals removed from consideration in
the VCCEP. Table 3 is the resulting list of chemicals detected in select biomonitoring programs
and considered as potential candidate chemicals for the VCCEP.
'I'iihlc 2: (heinionls Removed from Consklcriilion in the \ ('('IIP
CAS No.
( IIIMl( \l. \AMI.
Not
Ri-pork-d
to TSCA
IUR
Ozone
l)i'|K'k'lnr
I);iiiiu'(I
uiuk-r llu-
Muniiviil
Protocol
Ollu-r On^oin^
Risk
\ol Dikckd in
liioinoiiiiorin^
50-29-3
ethane, 1,1,1 -trichloro-2,2-bis(p-chloropheny 1)-
X
50-32-8
benzo(a)pyrene
X
X
53-19-0
ethane, 2-(o-chlorophenyl)-2-
(p-chloropheny 1)-1,1 -dichloro-
X
X
53-70-3
dibenz a,h anthracene
X
X
56-23-5
carbon tetrachloride
X
56-55-3
benz(a)anthracene
X
57-74-9
chlordane
X
X
60-57-1
1,4:5,8-Dimethanonaphthalene,
X
67-66-3
chloroform
X
71-55-6
methyl chloroform
X
72-20-8
1,4:5,8-dimethanonaphthalene,
X
X
72-43-5
methoxychlor
X
X
72-54-8
DDD
X
72-55-9
ethylene, 1,1 -dichloro-2,2-bis(p-chlorophenyl)-
X
72-56-0
ethane, 2,2-bis(p-ethylphenyl)-l,l-dichloro-
X
X
75-27-4
bromodichloromethane
X
76-44-8
heptachlor
X
X
77-47-4
hexachlorocyclopentadiene
X
82-68-8
pentachloronitrobenzene
X
8
-------
'I'iihlc 2: ( hcinienls Removed IVoin (onsidernlion in the \ ('('IIP
Not
Ozone
Oilier On^oino
Nol Dck'cU'd in
Ki-pork-il
DqK'k'lor
Risk
Uioinoiiiiorinn
to TSCA
l);iniU'd
CAS No.
( IIIMl( \l. \AMI.
IUR
uiuk-r llu-
MonliViil
Protocol
83-32-9
acenaphthene
X
X
83-33-0
1-Indanone
X
85-01-8
phenanthrene
X
86-73-7
fluorene
X
87-40-1
2,4,6-trichloroanisole
X
X
87-61-6
1,2,3-trichlorobenzene
X
87-68-3
hexachlorobutadiene
X
X
88-06-2
phenol, 2,4,6-trichloro-
X
X
95-44-3
L-threose
X
X
95-95-4
phenol, 2,4,5-trichloro-
X
X
96-12-8
propane, l,2-dibromo-3-chloro-
X
X
105-05-5
p-diethylbenzene
X
108-70-3
benzene, 1,3,5-trichloro-
X
115-32-2
dicofol
X
124-11-8
isononene
X
124-48-1
methane, dibromochloro-
X
124-76-5
isoborneol
X
126-72-7
1-propanol, 2,3-dibromo-, phosphate (3:1)
X
X
129-00-0
pyrene
X
131-11-3
dimethyl phthalate
X
132-64-9
dibenzofuran
X
205-99-2
benzo(b)fluoranthene
X
X
206-44-0
fluoranthene
X
207-08-9
benzo(k)fluoranthene
X
208-96-8
acenaphthalene
X
X
218-01-9
chrysene
X
309-00-2
1,4:5,8-dimethanonaphthalene,
X
X
319-84-6
cyclohexane, 1,2,3,4,5,6-hexachloro-, .alpha.-
X
319-85-7
cyclohexane, 1,2,3,4,5,6-hexachloro-, beta-isomer
X
319-86-8
cyclohexane, 1,2,3,4,5,6-hexachloro-, .delta.-
X
X
510-15-6
benzilic acid, 4,4'-dichloro-, ethyl ester
X
X
527-84-4
o-cymene
X
608-93-5
benzene, pentachloro-
X
X
615-13-4
2-indanone
X
X
634-66-2
benzene, 1,2,3,4-tetrachloro-
X
634-90-2
benzene, 1,2,3,5-tetrachloro-
X
X
789-02-6
ethane, 2-(o-chlorophenyl)-
2-(p-chloropheny 1)-1,1,1 -trichloro-
X
X
933-75-5
phenol, 2,3,6-trichloro-
X
X
1024-57-3
heptachlorepoxide
X
9
-------
'I'iihlc 2: ( hcinienls Removed IVoin (onsidernlion in the \ ('('IIP
Not
Ozone
Ollu-r On^oin^
Nol Di'k'ik'd in
Ripork'd
l)i'|K'k'lnr
Risk
liioinoiiiiorin^
to TSCA
I);iiiiu'(I
CAS No.
( IIIMl( \l. \AMI.
IUR
iiihIi'I' llu-
Muniiviil
Protocol
1746-01-6
dibenzo-p-dioxin, 2,3,7,8-tetrachloro-
X
1825-21-4
anisole, 2,3,4,5,6-pentachloro-
X
X
1836-75-5
ether, 2,4-dichlorophenyl p-nitrophenyl
X
2021-28-5
hydrocinnamic acid, ethyl ester
X
2051-24-3
decachlorobiphenyl
X
2234-13-1
naphthalene, octachloro-
X
2385-85-5
mirex
X
2847-30-5
pyrazine, 2-methoxy-3-methyl-
X
X
2921-88-2
chlorphyrifos
X
3268-87-9
dibenzo-p-dioxin, 1,2,3,4,6,7,8,9-octachloro-
X
3424-82-6
o,p'-DDE
X
X
5989-27-5
p-mentha-l,8-diene, (R)-(+)-
X
7439-92-1
lead
X
7439-97-6
mercury
X
7440-38-2
arsenic
X
12789-03-6
chlordane
X
X
23184-66-9
butachlor
X
25323-68-6
trichlorobiphenyl
X
25429-29-2
pentachlorobiphenyl
X
25512-42-9
dichloro-1,1 '-bipheny 1
X
26601-64-9
hexachlorobiphenyl
X
26914-33-0
tetrachlorobiphenyl
X
28655-71-2
heptachlorobiphenyl
X
31472-83-0
octachlorobiphenyl
X
33820-53-0
isopropalin
X
34465-46-8
hexachlorodibenzo-p-dioxin
X
35822-46-9
1,2,3,4,6,7,8-heptachlorodibenzo-p-dioxin
X
39001-02-0
octachlorodibenzofuran
X
39765-80-5
trans-nonachlor
X
40088-47-9
tetrabromodiphenyl ether
X
40321-76-4
1,2,3,7,8-pentachlorodibenzo-p-dioxin
X
50375-10-5
2,3,6-trichloroanisole
X
X
51207-31-9
dibenzofuran, 2,3,7,8-tetrachloro-
X
53494-70-5
endrin ketone
X
X
53742-07-7
nonachloro-1,1' -bipheny 1
X
54135-80-7
1,2,3-trichloro-4-methoxybenzene
X
55684-94-1
hexachlorodibenzofuran
X
57117-31-4
dibenzofuran, 2,3,4,7,8-pentachloro-
X
67562-39-4
dibenzofuran, 1,2,3,4,6,7,8-heptachloro-
X
10
-------
'I'iihlc 2: ( hcinienls Removed IVoin (onsidernlion in the \ ('('IIP
CAS No.
( IIIMl( \l. NAMI
Not
Ki-pork-d
to TSCA
IUR
Ozone
l)i'|K'k'lnr
l);iniU'(l
lllldl'l' llu-
Muniiviil
Pniloiol
Ollu-r On^oin^
Risk
\ul Dikck-d in
liioinoiiiiorin^
67708-83-2
dibromochloropropane
X
11
-------
'hihlc3: (hcinicnls Delected in Select liioinoniloriii" Progmms sind Considered Polcnlinl
Csindidiilc Chcmiciils for
\( ( i:p
CAS No.
( III Ml( Al. \AMI.
MIA MS
Ml ATS
Mil \AS
TEAMS
58-89-9
lindane
X
62-73-7
dichlorvos
X
67-64-1
acetone
X
71-43-2
benzene
X
X
X
75-25-2
tribromomethane
X
75-35-4
vinylidenechloride
X
78-59-1
isophorone
X
78-93-3
methyl ethyl ketone
X
79-01-6
trichloroethylene
X
X
79-34-5
1,1,2,2-tetrachloroethane
X
80-56-8
a-pinene
X
84-66-2
diethyl phthalate
X1
X
84-74-2
dibutyl phthalate
X1
X
85-68-7
butyl benzyl phthalate
X1
X
90-15-3
1-naphthol
X
90-43-7
o-phenylphenol
X
91-20-3
naphthalene
X
91-22-5
quinoline
X
91-64-5
coumarin
X
92-52-4
biphenyl
X
95-47-6
o-xylene
X
X
95-50-1
o-dichlorobenzene
X
X
95-63-6
1,2,4-trimethylbenzene
X
98-82-8
isopropylbenzene
X
100-41-4
ethylbenzene
X
X
100-42-5
styrene
X
X
103-23-1
diethyl hexyl adipate
X
106-42-3
p-xylene
X
106-46-7
p-dichlorobenzene
X
X
X
106-93-4
ethylene dibromide
X
107-06-2
ethylene dichloride
X
108-38-3
m-xylene
X
108-88-3
toluene
X
X
108-90-7
chlorobenzene
X
X
112-40-3
n-dodecane
X
115-86-6
phosphoric acid, triphenyl ester
X
115-96-8
ethanol, 2-chloro-, phosphate (3:1)
X
117-81-7
di(2-ethylhexyl)phthalate
X1
X
117-84-0
di-n-octyl phthalate
X1
X
118-74-1
hexachlorobenzene
X
120-82-1
benzene, 1,2,4-trichloro
X
12
-------
'I'iihlc 3: (heinionls Delected in Select IJioinoniloriii" Progmms mid C onsidered Potenti:il
( nndidnle ( heinicnls lor VCCKP
CAS No.
( MIMICAL \AMI.
\IIA\ IS
MIAIS
MIIXAS
I I . A MS
123-91-1
p-dioxane
X
124-18-5
decane
X
126-73-8
tributyl phosphate
X
127-18-4
tetrachloroethylene
X
X
X
128-37-0
2,6-di-tert-butyl-p-cresol
X
141-93-5
m-diethylbenzene
X
142-92-7
acetic acid, hexyl ester
X
333-41-5
diazinon
X
541-73-1
m-dichlorobenzene
X
X
556-67-2
octamethyl cy clotetrasil oxane
X
630-20-6
1,1,1,2-tetrachloroethane
X
1120-21-4
undecane
X
1330-20-7
mixed xylene
X
1330-78-5
phosphoric acid, tritolyl ester
X
28553-12-0
diisononylphthalate (DINP)
x1
1 Metabolites of chemicals with this footnote were found in human urine as reported in Ref. 5 which was just recently published in Oct.,
2000. Earlier presentations to Stakeholders did not reflect this new work
13
-------
How Did EPA further Cull the Potential Candidate Chemicals to Ensure VCCEP Focuses on
Relevant Chemicals?
In an effort to identify chemicals to which children would have the highest likelihood of
exposure, EPA evaluated each chemical listed in Table 3 to determine whether environmental data
also indicates that it may be present in a person's environment (in food, drinking water, indoor
air). If a chemical listed in Table 3 was found in at least one environmental database listed below,
it was identified as a candidate for the VCCEP:
FDA database of Everything Added to Food in the United States (EAFUS).
National Contaminant Occurrence Database (NCOD) (includes unregulated
drinking water contaminants).
National Human Exposure Assessment Survey (NHEXAS).
Total Exposure Assessment Methodology (TEAM).
EPA Office of Research and Development studies and other published indoor air
data.
The last three data sets were used to identify chemicals found in indoor air. Descriptions of these
environmental data bases are available in Appendix I of this document, and also in Refs. 3 and 4.
There was an exception to the above identification process which was raised and discussed
during the last stakeholder meeting. This exception relates to polybrominated diphenyl ethers
which as a class of chemicals were found to be increasing in concentration in human breast milk in
a recent Swedish study (Ref. 6). EPA used this study and TSCA Inventory Update Rule
reporting, which indicates that chemicals are manufactured in or imported to the United States, to
identify specific chemicals and their CAS Registry Numbers from this class of chemicals to be
included as candidate chemicals for this program (Ref. 13). In the case of chemicals contained in
breast milk, the biomonitoring evidence of exposure of the mother is also environmental evidence
of potential exposure through a food source of the child. Therefore the listing of the chemicals in
an environmental data base was not required for the chemical's selection.
EPA believes that lindane, dichlorvos, o-phenylphenol and diazinon although reported to
the TSCA Inventory Update Rule, did not have significant TSCA uses. Therefore these chemicals
were removed from VCCEP consideration. Coumarin was removed from consideration because
although it is included in EAFUS, it is a banned food additive.
The results of EPA's VCCEP candidate chemical selection process is shown in Table 4.
14
-------
Tsihle 4: W orking l.isl orCnndidnle (hcinionls to he Addressed In (lie
\ olunlsirv Children's C hemiciil KvalMillion Program
CAS No.
( IIIMl( Al. \AMI.
('Ih-iiik;iIs InnihI in 11 iiin;iii Tissiii-s
( lu'iiikills round in Drinking \\ ;iIit,
I'm id ;iii(l/or Indoor Air
NHANES
NHAT
NHEXAS
TEAMS
1 llllll;ill
Milk1
NCOD
EAFUS
INDOOR
AIR
67-64-1
acetone
Y
Y
Y
71-43-2
benzene
Y
Y
Y
Y
Y
Y
75-25-2
tribromomethane
Y
Y
Y
75-35-4
vinylidenechloride
Y
Y
Y
78-59-1
isophorone
Y
Y
78-93-3
methyl ethyl ketone
Y
Y
Y
79-01-6
trichloroethylene
Y
Y
Y
Y
Y
Y
79-34-5
1,1,2,2-tetrachloroethane
Y
Y
Y
80-56-8
a-pinene
Y
Y
Y
84-66-2
diethylphthalate
Y2
Y
Y
84-74-2
dibutyl phthalate
Y2
Y
Y
85-68-7
butyl benzyl phthalate
Y2
Y
Y
91-20-3
naphthalene
Y
Y
91-22-5
quinoline
Y
Y
Y
92-52-4
biphenyl
Y
Y
95-47-5
o-xylene
Y
Y
Y
Y
95-50-1
o-dichlorobenzene
Y
Y
Y
Y
95-63-6
1,2,4-trimethylbenzene
Y
Y
Y
98-82-8
isopropylbenzene
Y
Y
Y
100-41-4
ethylbenzene
Y
Y
Y
Y
100-42-5
styrene
Y
Y
Y
Y
Y
103-23-1
diethyl hexyl adipate
Y
Y
106-42-3
p-xylene
Y
Y
Y
106-46-7
p-dichlorobenzene
Y
Y
Y
Y
Y
106-93-4
ethylene dibromide
Y
Y
Y
15
-------
Tsihle 4: W orking l.isl orCnndidnle (heinionls to he Addressed In (lie
\ olunlsirv C hildren's ( hemic;il l.vnliinlioii Progriim
CAS No.
( IIIMl( Al. \AMI.
( lH'lllii;ils riiiiiid in 11 iiin;iii l issui-s
( lu'iiikills round in Drinking \\ ;iIit,
I'm id ;iihI/oi' Indoor Air
MIA MS
MIAI
MII.XAS
I I . A MS
1 llllll;ill
Mill.1
NCOD
IAII S
INDOOk
\lli
107-06-2
ethylene dichloride
Y
Y
Y
Y
108-38-3
m-xylene
Y
Y
Y
108-88-3
toluene
Y
Y
Y
Y
108-90-7
chlorobenzene
Y
Y
Y
Y
112-40-3
n-dodecane
Y
Y
117-81-7
di(2-ethylhexyl)phthalate
Y2
Y
Y
Y
117-84-0
di-n-octyl phthalate
Y2
Y
Y
118-74-1
hexachlorobenzene
Y
Y
Y
120-82-1
benzene, 1,2,4-trichloro
Y
Y
123-91-1
p-dioxane
Y
Y
124-18-5
decane
Y
Y
126-73-8
tributyl phosphate
Y
Y
127-18-4
tetrachloroethylene
Y
Y
Y
Y
Y
128-37-0
2,6-di-tert-butyl-p-cresol
Y
Y
141-93-5
m-diethylbenzene
Y
Y
142-92-7
acetic acid, hexyl ester
Y
Y
541-73-1
m-dichlorobenzene
Y
Y
Y
Y
556-67-2
octamethylcyclotetrasiloxane
Y
Y
630-20-6
1,1,1,2-tetrachloroethane
Y
Y
Y
1120-21-4
undecane
Y
Y
1163-19-5
decabromodiphenyl ether
Y
1330-20-7
mixed xylenes
Y
Y
Y
32534-81-9
pentabromodiphenyl ether
Y
32536-52-0
octabromodiphenyl ether
Y
68928-80-3
heDtabromodiDhenvl ether
Y
1. The chemicals in this column were chemicals identified in Ref. 6 that were also reported to the TSCA IUR
2. Metabolites of chemicals with this footnote were found in human urine as reported in Ref.5 which was just recently published in Oct., 2000. Earlier presentations to
Stakeholders did not reflect this new work
16
-------
What Chemicals Were Identified for the VCCEP Pilot?
The names of the 23 chemicals identified for the VCCEP pilot program are listed in Table
5 in Chemical Abstracts Service (CAS) Registry Number order.
A factor which influenced a chemical's selection for the pilot program was the expected
availability of hazard data. For purposes of the pilot, EPA wanted to select chemicals which had
or would soon have Tier 1 hazard data available. To identify such chemicals, EPA used two
indications of data availability:
whether data in the form of a Screening Information Assessment Report was available
from the Organization for Economic Cooperation and Development (OECD) Screening
Information Data Set (SIDS) Program as reported on
www.oecd.org/ehs/sidstable/index.htm (Ref. 7), and
whether chemicals had existing commitments in the HPV Challenge Program that had
early start years, i.e. 2000 or 2001 as reported on www.epa.gov/chemrtkyhpv 1990.htm
(Ref. 8).
Table 5 indicates which chemicals have been sponsored in the HPV Challenge Program
with start years 2000 or 2001, and which chemicals have available SIDS data.
In addition, while selecting chemicals for the VCCEP pilot, EPA considered the following:
• Chemicals were deferred from the VCCEP Pilot if the only biomonitoring or
environmental data supporting their selection were from NHATS or EAFUS. This
approach was taken because several stakeholders questioned whether these data sets were
appropriate for this chemical selection application.
Several phthalate esters were included in the "Working List of Candidate Chemicals to be
Addressed by the VCCEP" presented in Table 4 but were not included in Table 5 which
lists "Chemicals Identified for the VCCEP Pilot" despite the fact that the selection criteria
used indicates that they were Pilot-eligible. This approach was taken because EPA is
aware that several phthalates are currently the subjects of assessments being performed by
other government agencies, including some assessments that are specifically addressing
potential exposures and hazards to children. These other assessments include:
(1) The National Toxicology Program (NTP) Center for the Evaluation of Risks to
Human Reproduction (CERHR) which is preparing detailed assessments of the
scientific evidence for whether a given exposure or exposure circumstance may
pose a hazard to reproduction and the health and welfare of children for seven
phthalates - dibutyl phthalate (DBP), butylbenzyl phthalate (BBP), di-n-hexyl
phthalate (DnHP), di-n-octyl phthalate (DnOP), di(2-.ethylhexyl) phthalate
(DEHP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP). A
17
-------
separate assessment is being prepared for each phthalate by an expert panel chosen
specifically for the phthalates. Each assessment will be an evaluation of the
scientific evidence for whether adverse reproductive/developmental health effects
are associated with exposures to the phthalate and will include the expert panel's
conclusions about knowledge gaps for the phthalate (Ref. 10). Additional
information is available on web site http://ntp-
server.niehs.nih.gov/htdocs/liason/CERHRPhthalatesAnnct.html.
(2) The Consumer Product Safety Commission (CPSC) has convened a Chronic
Hazard Advisory Panel (CHAP) to evaluate the existing information regarding
whether chronic hazards (cancer, birth defects and gene mutations) may be posed
by DINP and the implications of these hazards on risks to children. The CHAP
expert panel will evaluate available hazard and exposure information, including
data generated by the CPSC in its testing laboratory on the amount of DINP that is
likely to come out of a toy when chewed or mouthed by a young child (Ref. 11).
(3) The Food and Drug Administration (FDA) is preparing a risk assessment of
DEHP in medical devices, including medical devices that result in exposure to
infants and newborn babies (Ref. 12). Additional information is available on web
site www.fda.gov/cdrh/present/DEHP GHTF.pdf.
In addition, risk assessments of DBP, BBP, DEHP, DINP and DIDP are being conducted
by scientists in the European Union (EU).
Most of these assessments are close to being complete. It would be neither practical nor
efficient to attempt to repeat all of the work of these other assessments under the VCCEP
program, but EPA believes the outcome of these assessments will provide helpful
information for deciding whether the risks of phthalates to children have been adequately
characterized, and which, if any, of the phthalates are appropriate for inclusion in the
VCCEP. In some cases, the work of these other bodies may facilitate review of phthalates
under the VCCEP. In other cases, EPA may determine that in light of these hazard and
risk assessments, further review under the VCCEP is either unnecessary or a low priority.
Accordingly, EPA is not deciding whether to include phthalates in the VCCEP Pilot at this
time. Instead, EPA will reevaluate the phthalates in approximately 6-9 months, after
many of the above-described assessments have been completed. The producers of
phthalates have agreed to provide the above assessments to EPA once they are completed,
and to include in that submission their assessment of the extent to which further evaluation
under the VCCEP is or is not necessary. EPA will review these materials when they are
received to determine which phthalates, if any, the Agency believes are appropriate for
further evaluation under the VCCEP at that time. The materials submitted by the
producers will be made publicly available and EPA will invite input from other
stakeholders before making its decisions.
Styrene was deferred from the pilot program because of ongoing assessments which are
18
-------
well advanced and substantially equivalent to the VCCEP in that they address potential
exposures and hazards to children. The assessments underway are listed below:
1) The Styrene Information and Research Center (SIRC), which is composed of
styrene manufacturers and users, has sponsored toxicological research covering
nearly all the health endpoints to be addressed by the VCCEP and has funded
additional two-generation reproduction and developmental neurotoxicity testing
(Ref. 9).
2) The Center for Risk Analysis at the Harvard School of Public Health has created a
risk assessment panel on styrene. The panel is undertaking an exposure assessment
and an independent hazard analysis of styrene and is expected to include an
evaluation of risks to children's health in its review (Ref. 9). The SIRC was asked
to submit exposure data to support the assessment being conducted at Harvard
(Ref. 9) which is expected to be available to EPA by July 2001.
3) EPA's Integrated Risk Information System (IRIS) program is currently conducting
an assessment of available hazard data on styrene which will address all of the
health endpoints included in the VCCEP. The IRIS assessment will address
children as a subpopulation in its review and may include both short term and long
term health values for children in the IRIS summary document which EPA will
issue for styrene (Ref. 9).
EPA believes these assessments will provide helpful information for whether the
risks of styrene to children have been adequately characterized. EPA may determine after
receipt of these hazard, exposure, and risk assessments, that further review under the
VCCEP is either unnecessary or a low priority. As with the case with phthalates,
materials submitted by the producers will be made publicly available and EPA will invite
input from other stakeholders before making its decision.
19
-------
Table 5: Chemicals Identified lor (lie YCCKP Pilot
CAS No.
( IIIMl( \l. \AMI.
nr\
( lull
< Hllllllll '
sii>s-
( lli'lllii;il- I'iiiiiiiI in lliiiiiiin
1 h-ur-
( ht'init'iiK I miiiicI
ill lliiiiiiin
I'm i i< >i i ii it-ii 1
Ml \M s
Ml i:\as
HAMS
III M
Mil 1.
NC'OI)
|\|H)()K
1 ll>
67-64-1
Acetone
Y
Y
Y
71-43-2
Benzene
Y
Y
Y
Y
Y
Y
75-35-4
Vinylidenechloride
Y
Y
Y
Y
78-93-3
Methyl ethyl ketone
Y
Y
Y
79-01-6
Trichloroethylene
Y
Y
Y
Y
Y
80-56-8
a-Pinene
Y
Y
Y
95-47-5
o-Xylene
Y
Y
Y
Y
Y
100-41-4
Ethylbenzene
Y
Y
Y
Y
Y
106-46-7
p-Dichlorobenzene
Y
Y
Y
Y
Y
106-93-4
Ethylene dibromide
Y
Y
Y
Y
107-06-2
Ethylene dichloride
Y
Y
Y
Y
108-38-5
m-Xylene
Y
Y
Y
Y
108-88-3
Toluene
Y
Y
Y
Y
Y
108-90-7
Chlorobenzene
Y
Y
Y
Y
Y
112-40-3
n-Dodecane
Y
Y
Y
123-91-1
p-Dioxane
Y
Y
Y
124-18-5
Decane
Y
Y
Y
127-18-4
T etrachloroethy lene
Y
Y
Y
Y
Y
Y
541-73-1
m-Dichlorobenzene
Y
Y
Y
Y
1120-21-4
Undecane
Y
Y
Y
1163-19-5
Decabromodiphenylether
Y
Y
32534-81-9
Pentabromodiphenvl ether
Y
Y
32536-52-0
Octabromodiphenvl ether
Y
Y
1. HPV Challenge commitment with early start year (2000 or 2001).
2. SIDS Screening Information Assessment Report is available.
3. The chemicals in this column were chemicals identified in Ref. 6 that were also reported to the TSCA IUR
20
-------
Has EPA Evaluated the Biomonitoring Data Related to VCCEPPilot chemicals?
EPA considers the biomonitoring data used for selection of chemicals for the VCCEP as
strong evidence of exposure and as providing a strong rationale for identifying a chemical in this
program. EPA evaluated the biomonitoring data not only for the detection of a chemical by the
monitoring program, but also the detection frequency and concentration of the chemical in the
tested biological medium. Examples of these data for the VCCEP chemicals are presented in
Table 6. The information in the table is intended to be illustrative rather than complete. Many of
the listed chemicals were also found in other human monitoring studies, some of which report the
frequency of occurrence and some of which do not. The blood levels shown in the table are from
the National Health and Nutrition Examination Survey III (NHANES III); the breath data are
from the Total Exposure Assessment Methodology (TEAM) studies; and the breast milk data are
from a recent Swedish study (Ref. 6). A number of the candidate chemicals were also studied in
the National Human Exposure Assessment Survey (NHEXAS), but these data are not included in
the table because all of the chemicals found in NHEXAS were also reported in NHANES III.
With the possible exception of the Swedish breast milk study, all of the monitoring
programs from which these data were drawn were relatively large, broad-scale studies. The blood
data were derived from a subset of the national scale NHANES III population and were used to
establish reference ranges for the chemicals studied. NHEXAS involved surveys in EPA Region 5
(Minnesota, Wisconsin, Michigan, Illinois, Indiana, Ohio), in the State of Arizona, and in the
Baltimore metropolitan area. TEAM studies were done in communities in New Jersey, North
Dakota, North Carolina, and California. Because of the size and scope of these programs, the
detection of a chemical at even a relatively low frequency may indicate exposure to a large
population. The significance of the reported tissue concentrations is difficult to interpret without
information about the exposure events that led to a chemical's occurrence in that tissue and a
detailed knowledge of that chemical's metabolic fate. At present, the reported data are best used
simply as a qualitative indicator that exposure has occurred.
The first substance in Table 6 does not exactly match the corresponding entries on the pilot
chemical list. However, EPA believes that the TEAM data on the mixture of meta and para
isomers of dichlorobenzene are relevant to the listing of m-dichlorobenzene and p-
dichlorobenzene as individual isomers. Likewise, the NHANES III data on mixed meta and para
isomers of xylene are relevant to the listing of m-xylene as an individual isomer in the pilot
chemical list. Also the listing of polybrominated diphenyl ethers and the data from the Swedish
study (Ref. 6) is relevant to three entries on the pilot chemical list (decabromodiphenyl ether,
pentabromodiphenyl ether, and octabromodiphenyl ether).
21
-------
Tsihle 6: I'reqiienev of Detection ;iihI Tissue Concent ml ion
of Select VCCKP Pilot ( heinicnls in Miiinsin Monitoring Studies
CAS No.
C IIIMl( \l. \AMI.
M 1.1)11 M
1)1. I I.C 1 ION
1 kl-Ol i \o
< ()\( 1 \ I KA I l()\
m,p-Dichlorobenzene
breath
91% of 49
GM1 =1.81 ug/m3
m,p-Xylene
blood
>75% of 649
med2 = 0.19 ppb
Polybrominated diphenylethers
milk
mean = 4 ng/g
67-64-1
Acetone
blood
> 75% of 1062
med = 1800 ppb
71-43-2
Benzene
blood
>75% of 883
med = 0.06 ppb
75-35-4
Vinylidene chloride
breath
95% of 49
WAGM3 = 6.6 ug/m3
78-93-3
Methyl ethyl ketone
blood
>75% of 1101
med =5.4 ppb
79-01-6
Trichloroethylene
blood
13% of 677
80-56-8
a-Pinene
breath
92% of 110
GM = 0.94 ug/m3
95-47-6
o-Xylene
blood
>75% of 711
med =0.11 ppb
100-41-4
Ethylbenzene
blood
>75% of 631
med = 0.06 ppb
106-46-7
p-Dichlorobenzene
blood
> 75% of 1037
med = 0.33 ppb
106-93-4
Ethylene dibromide
breath
3% of 300
GM = 0.4 ug/m3
107-06-2
Ethylene dichloride
breath
(frequency data not
available)
WAGM =0.19 ug/m3
108-88-3
Toluene
blood
>75% of 804
med = 0.28 ppb
108-90-7
Chlorobenzene
blood
21% of 1024
112-40-3
n-Dodecane
breath
30% of 110
GM = 0.19 ug/m3
123-91-1
p-Dioxane
breath
8% of 110
GM= 0.05 ug/m3
124-18-5
Decane
breath
53% of 110
GM= 0.27 ug/m3
127-18-4
T etrachloroethy lene
blood
> 75% OF 590
med= 0.06 ppb
1120-21-4
Undecane
breath
56% of 110
GM= 0.28 ug/m3
1 GM = geometric mean
2
Med = median
3
WAGM = weighted average geometric mean
22
-------
What Companies Manufacture or Import the VCCEP Pilot Chemicals?
Table 7 provides a listing, for each pilot chemical, of the companies that either
manufacture the chemical in or import the chemical to the U.S. The company names shown are as
reported to the 1998 TSCA Inventory Update Rule on a non-confidential basis. This information
is provided to facilitate the formation of consortia of VCCEP sponsor companies so that burdens
of the voluntary program may be shared.
23
-------
'I'iihlc 7: Mnniirncliirers ;md Importers of VCCKP Pilot Chemiciils 21s reported to the 1998
I'SCA Invenlorv I pdsite Kule 011 ;i \on-(onl'idcnti;il linsis
CAS Number
( III Ml( Al. NAMI
( OMPAM NAMI.
67-64-1
Acetone
3M
ARCO CHEMICAL CO.
ARISTECH CHEMICAL CORPORATION
CELANESE, LTD.
CHEMCENTRAL CORP.
CIBA SPECIALTY CHEMICALS CORPORATION
COASTAL REFINING & MARKETING, INC.
DAKOTA GASIFICATION COMPANY
DOW CHEMICAL COMPANY
EASTMAN CHEMICAL COMPANY
EL DORADO REFINING CO.
EXXON CORPORATION
GENERAL ELECTRIC CO.
GEORGIA GULF CORPORATION
HUNTSMAN SPECIALTY CHEMICAL CORPORATION
H.B. FULLER CO.
ICI ACRYLICS, INC
KIMBERLY-CLARK PRINTING TECHNOLOGIES
PARISH CHEMICAL CO.
ROHM & HAAS CO.
SHELL OIL CO.
SUNOCO, INC.
THE GOODYEAR TIRE & RUBBER COMPANY
UNION CARBIDE CORPORATION
WINDSOR CHEMICALS INC.
71-43-2
Benzene
ALLIED-SIGNAL INC.
AMOCO CORPORATION
BP OIL COMPANY
CANADA IMPERIAL OIL LIMITED
CATLETTSBURG REFINING LLC
CHALMETTE REFINING, LLC
CHEVRON PRODUCTS CO.
CITGO PETROLEUM CORPORATION
CITGO REFINING & CHEMS. CO, L.P.
COASTAL EAGLE POINT OIL COMPANY
COASTAL FUELS MARKETING, INC.
COASTAL REFINING & MARKETING, INC.
DAKOTA GASIFICATION COMPANY
DELTECH CORPORATION
DOW CHEMICAL COMPANY
EL DORADO REFINING CO.
EXXON CORPORATION
24
-------
'I'iihlc 7: Mnniirncliirers ;md Importers of VCCKP Pilot Chemiciils 21s reported to the 1998
I'SCA Invenlorv I pdsite Kule 011 ;i \on-(onl'idcnli;il linsis
CAS Number
( IIIMl( Al. NAMI
<"()MPAN^ NAMI.
E.I. DUPONT DE NEMOURS & CO. INC.
FINA OIL & CHEMICAL CO., INC.
FISHER SCIENTIFIC CO, L.L.C.
HUNTSMAN CHEMICAL CORPORATION
HUNTSMAN PETROCHEMICAL CORPORATION
KOCH PETROLEUM GROUP, LP
LYONDELL-CITGO REFINING LP
MARATHON ASHLAND PETROLEUM LLC.
MOBIL CHEMICAL COMPANY
MOTIVA ENTERPRISES, LLC
NISSEKI CHEMICAL TEXAS INC
PARISH CHEMICAL CO.
PETRO-CANADA CHEMICALS INC.
SHELL OIL CO.
SK GLOBAL AMERICA, INC.
STERLING CHEMICALS, INC.
SUNOCO, INC
THE SOMERSET REFINERY, INC.
75-35-4
Vinylidene chloride
DOW CHEMICAL COMPANY
PPG INDUSTRIES, INC.
78-93-3
Methyl ethyl ketone
3M
BASF CORPORATION
CELANESE, LTD.
CIBA SPECIALTY CHEMICALS CORPORATION
EXXON CORPORATION
E.I. DUPONT DE NEMOURS & CO. INC.
GIBRALTAR CHEMICAL WORKS, INC.
HEMPEL COATINGS (USA), INC.
ICI AMERICAS INC.
KIMBERLY-CLARK PRINTING TECHNOLOGIES
MALLINCKRODT BAKER, INC.
MITSUBISHI INT'L CORP.
MITSUI PLASTICS, INC.
SHELL OIL CO.
ZENECA INC.
79-01-6
Trichloroethylene
BROWNING CHEMICAL CORP.
DOW CHEMICAL COMPANY
ENICHEM AMERICA, INC.
FORMOSA PLASTICS CORPORATION
ICC CHEMICAL CORP.
25
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'I'iihlc 7: Mnniirncliirers ;md Importers of VCCKP Pilot Chemiciils 21s reported to the 1998
I'SCA Invenlorv I pdsite Kule 011 ;i \on-(onl'idcnli;il linsis
CAS Number
( IIIMl( Al. NAMI
<"()MPAN^ NAMI.
ICI AMERICAS INC.
PPG INDUSTRIES, INC.
80-56-8
a-Pinene
BUSH BOAKE ALLEN INC.
HERCULES INC.
95-47-6
o-Xylene
CHALMETTE REFINING, LLC
EXXON CORPORATION
KOCH PETROLEUM GROUP, LP.
LYONDELL-CITGO REFINING LP
PETRO-CANADA CHEMICALS INC.
PHILLIPS PETROLEUM COMPANY
SK GLOBAL AMERICA, INC.
THE SOMERSET REFINERY, INC.
ZENECA AG PRODUCTS
100-41-4
Ethylbenzene
AMOCO CORPORATION
ARCO CHEMICAL CO.
BASF CORPORATION
CHEVRON CHEMICAL CO., LLC.
COASTAL FUELS MARKETING, INC.
DELTECH CORPORATION
DOW CHEMICAL COMPANY
FINA OIL & CHEMICAL CO., INC.
FMC CORPORATION
GENERAL ELECTRIC CO.
HEMPEL COATINGS (USA), INC.
HUNTSMAN CHEMICAL CORPORATION
HUNTSMAN POLYMERS CORPORATION
LILLY INDUSTRIES, INC.
NIPPON PAINT (AMERICA) CORP.
NOVA CHEMICALS INC.
SHELL OIL CO.
SPIES HECKER, INC.
STANDOX NORTH AMERICA
STERLING CHEMICALS, INC.
THE SOMERSET REFINERY, INC.
WESTLAKE STYRENE CORPORATION
ZENECA AG PRODUCTS
106-46-7
p-Dichlorobenzene
PHILLIPS PETROLEUM COMPANY
PPG INDUSTRIES, INC.
26
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'I'iihlc 7: Mnniirncliirers ;md Importers of VCCKP Pilot Chemiciils 21s reported to the 1998
I'SCA Invenlorv I pdsite Kule 011 ;i \on-(onl'idcnli;il linsis
CAS Number
( IIIMl( Al. NAMI
( OMPAM NAMI.
SOLUTIA INC
STANDARD CHLORINE OF DELAWARE
106-93-3
Ethylene dibromide
AMERIBROM, INC.
GREAT LAKES CHEMICAL CORPORATION
107-06-2
Ethylene dichloride
BORDEN CHEMICAL, INC.
CEDAR CHEMICAL CORP.
CONDEA VISTA COMPANY
DOW CHEMICAL COMPANY
FORMOSA PLASTICS CORPORATION
GEORGIA GULF CORPORATION
OCCIDENTAL CHEMICAL CORPORATION
PPG INDUSTRIES, INC.
THE GEON COMPANY
VULCAN CHEMICALS
WESTLAKE MONOMERS CORP.
108-38-3
m-Xylene
AMOCO CORPORATION
THE SOMERSET REFINERY, INC.
ZENECA AG PRODUCTS
108-88-3
Toluene
3M
AMOCO CORPORATION
BASF CORPORATION
BONAKEMI USA, INC
CATLETTSBURG REFINING LLC
CHALMETTE REFINING, LLC
CHEMCENTRAL CORP.
CHEVRON CHEMICAL CO., LLC.
CITGO PETROLEUM CORPORATION
CITGO REFINING & CHEMS. CO, L.P.
COASTAL EAGLE POINT OIL COMPANY
COASTAL FUELS MARKETING, INC.
COASTAL REFINING & MARKETING, INC.
CREANOVA INC.
DAKOTA GASIFICATION COMPANY
DIC INTERNATIONAL (USA), INC.
DOW CHEMICAL COMPANY
EL DORADO REFINING CO.
ELF ATOCHEM NORTH AMERICA, INC.
27
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'I'iihlc 7: Mnniirncliirers ;md Importers of VCCKP Pilot Chemiciils 21s reported to the 1998
I'SCA Invenlorv I pdsite Kule 011 ;i \on-(onl'idcnti;il linsis
CAS Number
( III Ml( Al. NAMI
<"()MPAN^ NAMI.
EP TECHNOLOGIES LLC
ESSO STANDARD OIL CO. PUERTO RICO
EXXON CORPORATION
E.I. DUPONT DE NEMOURS & CO. INC.
FINA OIL & CHEMICAL CO., INC.
FISHER SCIENTIFIC CO, L.L.C.
GENERAL ELECTRIC CO.
GREAT WESTERN CHEMICAL CO.
HEMPEL COATINGS (USA), INC.
HUNTSMAN CHEMICAL CORPORATION
HUNTSMAN PETROCHEMICAL CORPORATION
HUNTSMAN POLYMERS CORPORATION
ITOCHU SPECIALTY CHEMICALS
KIMBERLY-CLARK PRINTING TECHNOLOGIES
KOCH PETROLEUM GROUP, LP
LIOCHEM, INC.
LYONDELL-CITGO REFINING LP
MALLINCKRODT BAKER, INC.
MARATHON ASHLAND PETROLEUM LLC.
MEGALOID LABORATORIES LTD.
MITSUI PLASTICS, INC.
MOBIL CHEMICAL COMPANY
NIPPON PAINT (AMERICA) CORP.
NORDIC SYNTHESIS INC.
OCCIDENTAL CHEMICAL CORPORATION
RED SPOT PAINT & VARNISH CO., INC.
SHELL OIL CO.
SHIN-ETSU SILICONES OF AMERICA, INC.
SIEGWERK, INC.
SK GLOBAL AMERICA, INC.
STERLING CHEMICALS, INC.
SUNOCO, INC
VAN WATERS & ROGERS INC.
VON ROLL ISOLA USA, INC.
WESTLAKE STYRENE CORPORATION
ZENECA AG PRODUCTS
ZENECA INC.
108-90-7
Chlorobenzene
PPG INDUSTRIES, INC.
SOLUTIA INC
THE GEON COMPANY
112-40-3
n-Dodecane
CONDEA VISTA COMPANY
28
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'I'iihlc 7: Mnniirncliirers ;md Importers of VCCKP Pilot Chemiciils 21s reported to the 1998
I'SCA Invenlorv I pdsite Kule 011 ;i \on-(onl'idcnli;il linsis
CAS Number
( IIIMl( Al. NAMI
<"()MPAN^ NAMI
HUMPREY CHEMICAL CO.
SHELL OIL CO.
SOLUTIA INC
123-91-1
p-Dioxane
FERRO CORPORATION
124-18-5
Decane
CASCHEM, INCORPORATED
CONDEA VISTA COMPANY
PHILLIPS PETROLEUM COMPANY
STERLING CHEMICALS, INC.
127-18-4
T etrachloroethy lene
DOW CHEMICAL COMPANY
FORMOSA PLASTICS CORPORATION
GREAT WESTERN CHEMICAL CO.
ICI AMERICAS INC.
PPG INDUSTRIES, INC.
THE GEON COMPANY
VULCAN CHEMICALS
541-73-1
m-Dichlorobenzene
STANDARD CHLORINE OF DELAWARE
1120-21-4
Undecane
CONDEA VISTA COMPANY
SHELL OIL CO.
1163-19-5
Decabromodiphenylether
AMERIBROM, INC.
CHISSO AMERICA, INC.
DOW CHEMICAL COMPANY
GREAT LAKES CHEMICAL CORPORATION
32534-81-9
Pentabromodiphenyl ether
GREAT LAKES CHEMICAL CORPORATION
32536-52-0
Octabromodiphenylether.
GREAT LAKES CHEMICAL CORPORATION
29
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References
1. Chemical Manufacturers Association (CMA). Letter with 3 attachments from Sandra
Tirey to James Aidala and Susan Wayland, U.S. EPA, Office of Prevention, Pesticides and
Toxics, Washington, DC. (September 21, 1999)
2. American Public Health Association (APHA), Children's Environmental Health Network,
Environmental Defense, National Environmental Trust, Physicians for Social
Responsibility. Comments on the Environmental Protection Agency's "Framework for a
Voluntary Children's Chemical Evaluation Program." (April 12, 2000).
3. USEPA, "Framework for a Voluntary Children's Chemical Evaluation Program"(April 12,
2000).
4. Eastern Research Group, "Draft Users Guide for the Endocrine Disruptor Priority Setting
Database." (May 22, 2000).
5. Blount, B.C., Silva, M.J., Caudill, S.P., Needham, L.L., Pirkle, J.L., Sampson, E.J.,
Lucier, G.W., Jackson, R.J., and Brock, J.W. "Levels of seven urinary phthalate
metabolites in a human reference population." Environmental Health Perspectives.
108:979-982. (2000).
6. Noren K., Meironte D. "Contaminants in Swedish Human Milk. Decreasing levels of
organochlorine and increasing levels of organobromine compounds." Organohalogen
Compounds 38:1-4 (1998).
7. OECD, "Status of OECD SIDS Chemicals," www.oecd.org/ehs/sidstable/index.htm
8. USEPA, "1990 HPV Chemical List," www.epa.gov/chemrtk/hpv 1990.htm
9. Styrene Information and Research Center (SIRC). Comments on the Framework
Document for the VCCEP. (May 31, 2000).
10. NTP, CERHR. Review of Phthalates. (July 14, 2000).
11. CPSC. "Notice of meeting of Chronic Hazard Advisory Panel on Diisononyl Phthalate
(DINP)." 65 FR 49231 (August 11, 2000).
12. USFDA. Center for Devices and Radiological Health. "PVC and DEHP." Presentation by
Dr. David W. Feigal to the 8th GHTF Conference, Ottawa, Canada. (September 20, 2000).
13. USEPA. Letter from Doyoung Lee to Henry Lau, Charles Auer, Ward Penberthy, N Patel,
and James Darr. "Candidate Chemicals for Children's Testing Program." April 12, 2000.
30
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APPENDIX I
DESCRIPTIONS OF DATA
SOURCES USED FOR CHEMICAL SELECTION
FOR THE VCCEP
National Health and Nutrition Examination Survey III (NHANES III):
NHANES III was conducted between 1988 through 1994 on 33,994 people and focused
primarily on basic health and nutritional parameters such as blood pressure, immunization
status, and nutritional blood measures. NHANES III included a special study that looked
at the blood levels of 32 volatile organic compounds (VOCs) in a sample of about 800
volunteers from the overall NHANES study. Eleven compounds were found with high
frequency and the data on these 11 compounds were sufficient to establish reference levels
(e.g. median, 95th percentile) for the nonoccupational^ exposed U.S. population. Another
five compounds were found in at least 10% of the samples.
Reference
Ashley et al 1994. Blood Concentrations of Volatile Organic Compounds in a
Nonoccupational ly Exposed US Population and in Groups with Suspected Exposure.
Clin. Chem. Vol. 40 No. 7, pp. 1401-1404.
National Human Adipose Tissue Survey
The National Adipose Tissue Survey (NHATS) analyzed human adipose (fatty) tissue
specimens to monitor human exposure to potentially toxic chemicals. Pathologists and
medical examiners from 47 metropolitan statistical areas collected tissue specimens from
cadavers and surgical patients during the time period between 1970-1987. These
specimens were analyzed for organochlorine pesticides, PCBs, dioxins and furans, volatile
organics, semivolatile organics, and trace elements. However, not all compounds were
analyzed over the complete time period from 1970 - 1987. Throughout the 1970's and
early 1980's the chemical residues of primary interest where organochlorine pesticides and
PCBs. During 1982, volatile and semivolatile organic compounds were included in the
survey. NHATS was the primary activity of the National Human Monitoring Program
(NHMP), operated by the EPA Office of Pollution Prevention and Toxics
(USEPA/OPPT), until the early 1990s.
NHATS References
Dioxins and Dibenzofurans in Adipose Tissue of the General Population and
Selected Sup-populations, American Journal of Public Health, V. 84, 1994
"Chlorinated Dioxins and Furans in the General U.S. Population NHATS FY87
31
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Results," EPA Office of Toxic Substances, 1992 (NTIS PB92-180157)
"Broad Scan Analysis of the FY82 National Human Adipose Tissue Survey Specimens
Volume I - Executive Summary," EPA Office of Toxic Substances, 1986 (NTIS
PB87-177218)
"Semivolatile Organic Compounds in the General U.S. Population: NHATS FY86
Results Volume I", EPA Office of Pollution Prevention and Toxics, 1994. (NTIS
PB94-209525)
"Characterization of HRGC/MS Unidentified Peaks from the Analysis of Human
Adipose Tissue Volume I - Technical Approach," EPA Office of Toxic Substances,
1987 (NTIS PB88-100367)
"Broad Scan Analysis of the FY82 National Human Adipose Tissue Survey Specimens
Volume II - Volatile Organic Compounds," EPA Office of Toxic Substances, 1986
(NTIS PB87-177226)
"Characterization of HRGC/MS Unidentified Peaks from the Analysis of Human
Adipose Tissue Volume II - Appendices," EPA Office of Toxic Substances, 1987
(NTIS PB88-100375)
"Broad Scan Analysis of Human Adipose Tissue: Volume III - Semivolatile Organic
Compounds," EPA Office of Toxic Substances, 1986 (NTIS PB87-180519)
"Broad Scan Analysis of National Human Adipose Tissue Survey Specimens Volume
IV - Polychlorinated Dibenzo-p-Dioxins (PCDDs) and Polychlorinated Dibenzofurans
(PCDFs)," EPA Office of Toxic Substances, 1986. (NTIS PB87-177234)
"Broad Scan Analysis of the FY82 National Human Adipose Tissue Survey Specimens
Volume V - Trace Elements," EPA Office of Toxic Substances, 1986. (NTIS
PB87-180527)
"Mass Spectral Confirmation of Chlorinated and Brominated Diphenylethers in
Human Adipose Tissues," EPA Office of Toxic Substances, 1990 (NTIS PB91-159699)
"Brominated Dioxins and Dibenzofurans in Human Adipose Tissue," EPA Office of
Toxic Substances, 1990 (NTIS PB91-103507)
"Identification of SARA Compounds in Adipose Tissue," EPA Office of Toxic
Substances, 1989 (NTIS PB90-132564)
National Human Exposure Assessment Survey:
32
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The National Human Exposure Assessment Survey (NHEXAS) describes the distribution
of human exposure to multiple chemicals from multiple routes and sources on a
community and regional scale and its association with environmental concentrations and
personal activities. NHEXAS focuses on the comprehensive exposure of people to
multiple environmental pollutants from multiple routes and sources to address some of the
limitations of single-chemical, and single media exposure route studies. To accomplish
this, hundreds of subjects were randomly selected from several areas of the country and
asked to participate. Researchers measured the levels of chemicals in the air participants
breathe; in food, drinking water, and other beverages; and in the soil and dust around their
homes. Measurements were also made of chemicals in biological samples (including blood
and urine) provided by some participants. Finally, participants completed questionnaires
to help identify possible sources of exposure to chemicals. NHEXAS in its fullest sense is
a conceptual design which utilizes (a) representative sampling (probability-based sampling
of a given population), (b) environmental sampling of air, water, soil/dust, © personal
monitoring of air, food and beverages (duplicate diet) and dermal measurements, (d)
biomarkers, and (e) questionnaires.
NHEXAS References
Sampling Design, Response Rates, and Analysis Weights for the National Human
Exposure Assessment Survey (NHEXAS) in EPA Region 5, R.W. Whitmore, M.Z.
Byron, C.A. Clayton, K.W. Thomas, H.S. Zelon, E.D. Pellizzari, P.J. Lioy and J.J.
Quackenboss, Journal of Exposure Analysis and Environmental Epidemiology, Volume 9,
Number 5, September/October 1999, pages 369-380.
National Human Exposure Assessment Survey (NHEXAS): Distributions and
Associations of Lead, Arsenic and Volatile Organic Compounds in EPA Region 5, C.A.
Clayton, E.D. Pellizzari, R.W. Whitmore, R.L. Perritt, and J.J. Quackenboss, Journal of
Exposure Analysis and Environmental Epidemiology, Volume 9, Number 5,
September/October 1999, pages 381-392.
Analysis of Mercury in Hair of EPA Region V Population, E.D. Pellizzari, R. Fernando,
G.M. Cramer, G. M. Meaburn, and K. Bangerter, Journal of Exposure Analysis and
Environmental Epidemiology, Volume 9, Number 5, September/October 1999, pages 393-
401.
Population-based Dietary Intakes and Tap Water Concentrations for Selected Elements in
the EPA Region V National Human Exposure Assessment Survey (NHEXAS), Kent W.
Thomas, Edo D. Pellizzari, and Maurice R. Berry, Journal of Exposure Analysis and
Environmental Epidemiology, Volume 9, Number 5, September/October 1999, pages 402-
413.
Responses to the Region V NHEXAS Time/Activity Diary, N.C.G. Freeman and P.J.
Lioy, Journal of Exposure Analysis and Environmental Epidemiology, Volume 9, Number
33
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5, September/October 1999, pages 414-426.
National Human Exposure Assessment Survey (NHEXAS) study in Arizona-Introduction
and Preliminary Results, Gary L. Robertson, Michael D. Lebowitz, Mary Kay O'Rourke,
Sydney Gordon, and Demetrios Moschandreas, Journal of Exposure Analysis and
Environmental Epidemiology, Volume 9, Number 5, September/October 1999, pages 427-
434.
Evaluations of Primary Metals from NHEXAS Arizona: Distributions and Preliminary
Exposures, Mary Kay O-Rourke, Peter K. Van de Water, Shan Jin, Seumas P. Rogan,
Aaron D. Weiss, Sydney M. Gordon, Demetrios M. Moschandreas, and Michale D.
Lebowitz, Journal of Exposure Analysis and Environmental Epidemiology, Volume 9,
Number 5, September/October 1999, pages 435-445.
Spatial Distributions of Arsenic Exposure and Mining Communities from NHEXAS
Arizona, Mary Kay O'Rourke, Seumas P. Rogan, Shan Jin, and Gary L. Robertson,
Journal of Exposure Analysis and Environmental Epidemiology, Volume 9, Number 5,
September/October 1999, pages 446-455.
Residential Environmental Measurements in the National Human Exposure Assessment
Survey (NHEXAS) Pilot Study in Arizona: Preliminary Results for Pesticides and VOCs,
Sidney M. Gordon, Patrick J. Callahan, Marcia G. Nishioka, Marielle C. Brinkman, Mary
Kay O'Rourke, Michael D. Lebowitz, and Demetrios M. Moschandreas, Journal of
Exposure Analysis and Environmental Epidemiology, Volume 9, Number 5,
September/October 1999, pages 456-470.
Mass Data Massage: An Automated Data Processing System Used for NHEXAS,
Arizona, Mary K. O'Rourke, Luis M. Fernandez, Clinton N. Bittel, Jared L. Sherrill, Tony
S. Blackwell, and D. Royce Robbins, Journal of Exposure Analysis and Environmental
Epidemiology, Volume 9, Number 5, September/October 1999, pages 471-484.
A Longitudinal Investigation of Selected Pesticide Metabolites in Urine, David L.
Macintosh, Larry L. Needham, Karen A. Hammerstrom, and P. Barry Ryan, Journal of
Exposure Analysis and Environmental Epidemiology, Volume 9, Number 5,
September/October 1999, pages 485-493.
A Longitudinal Investigation of Selected Pesticide Metabolites in Urine, David L.
Macintosh, Larry L. Needham, Karen A. Hammerstrom, and P. Barry Ryan, Journal of
Exposure Analysis and Environmental Epidemiology, Volume 9, Number 5,
September/October 1999, pages 494-501.
Temporal Variability of Microenvironmental Time Budgets in Maryland, Scott L. Echols,
David L. Macintosh, Karen A. Hammerstrom, and P. Barry Ryan, Journal of Exposure
Analysis and Environmental Epidemiology, Volume 9, Number 5, September/October
34
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1999, pages 502-512.
Quantification of Children's Hand and Mouthing Activities Through A Videotaping
Methodology, Karyn J. Reed, Marta Jimenez, Natalie C. G. Freeman, and Paul J. Lioy,
Journal of Exposure Analysis and Environmental Epidemiology, Volume 9, Number 5,
September/October 1999, pages 513-520.
The EL Sampler: A Press Sampler for the Quantitative Estimation of Dermal Exposure to
Pesticides in House Dust, Rufus D. Edwards and Paul J. Lioy, Journal of Exposure
Analysis and Environmental Epidemiology, Volume 9, Number 5, September/October
1999, pages 521-529.
Total Exposure Assessment Methodology:
The Total Exposure Assessment Methodology (TEAM) study was designed to develop
methods to measure individual total exposure (exposure through air, food, and water) and
resulting body burden of toxic and carcinogenic chemicals, and to apply these methods
within a probability-based sampling framework to estimate the exposures and body
burdens of urban populations in several U.S. cities. The TEAM Study reports the results
of eight monitoring studies performed in five communities during different seasons of the
year. Breath, personal, outdoor, and water samples were collected for volatile organic
compounds. Results of the TEAM Study are reported in a four volume report entitled:
The Total Exposure Assessment Methodology (TEAM) Study. Two of the four volumes
provide data in a form that can be incorporated into a priority-setting database. These
volumes are: (1) The Total Exposure Assessment Methodology (TEAM) Study: Elizabeth
and Bayonne, New Jersey, Devils Lake, North Dakota, and Greensboro, North Carolina:
Volume II. Part 2 and (2) The Total Exposure Assessment Methodology (TEAM) Study:
Selected Communities in Northern and Southern California: Volume III. Altogether the
TEAM Study provides data on about 30 volatile organic compounds from breath, personal
air, outdoor air, and water samples.
Everything Added to Food in the United States Database:
The Everything Added to Food in the United States (EAFUS) database is a compilation of
various food additives created under an ongoing program known as the Priority-based
Assessment of Food Additives (PAFA). This database is maintained by the U.S. Food and
Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) and
contains information regarding ingredients added to food that FDA has approved as direct
or indirect food additives, or listed and affirmed as generally regarded as safe (GRAS).
The EAFUS database contains administrative and chemical information for more than
3,000 substances added to food. For 2,000 of those substances, toxicological information
is also available. The database contains only a partial list of all food ingredients that may
be lawfully added to food due to the fact that under federal law, some ingredients may be
35
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added to food under a GRAS determination made independently from FDA. A list of all
of the substances in EAFUS is available free of charge at
http://vm.cfsan.fda.gov/~dms/eafus.html. The fields available on-line include the name of
the chemical, the CAS number, the type of toxicologic information available for the
chemical in the EAFUS database, and the CFR citation where the chemical is regulated.
The complete database {Food Additives Toxicology, Regulation, and Properties by
Fergus M. Clydesdale, published December 1996, catalog number 8580), including
abstracts of over 7,000 toxicology studies, is available on CD-ROM from CRC Press for
$375.
National Drinking Water Contaminant Occurrence Database:
The National Drinking Water Contaminant Occurrence Database (NCOD) provides data
on the occurrence and concentration of unregulated contaminants in drinking water.
NCOD was developed to satisfy the statutory requirements set by Congress in the 1996
SDWA amendments. The purpose of the database is to support EPA's decisions related to
identifying contaminants for regulation and subsequent regulation development. The
NCOD contains occurrence data from both Public Water Systems and other sources (like
the U.S. Geological Survey National Water Information System) on physical, chemical,
microbial and radiological contaminants for both detections and non-detects.
NCOD contains occurrence monitoring from sampling locations throughout a Public
Water System, therefore a detection value does not necessarily mean the contaminant
would be found at the tap. There are some summary statistics, but no actual analysis of the
data is provided. Also, NCOD contains data for only unregulated contaminants required to
be monitored by public water systems, even though EPA has not set health-based drinking
water maximum contaminant levels for this subset of contaminants. This subset is covered
by the Unregulated Contaminant Monitoring Rule, or UCMR. Currently the NCOD does
not contain occurrence data for all water systems and all states. The only Public Water
System data contained in NCOD is data that has been reported by States to the Safe
Drinking Water Information System (SDWIS). Historical data goes back to 1983.
EPA OR I) Sources of Air Monitoring Data:
The ORD sources consist of eight journal articles and reports that provide data on
approximately 400 compounds. Quantitative information on the concentrations and
frequency of occurrence of pollutants in ambient and indoor air is available. There are also
some quantitative data on the concentrations and frequency of occurrence of pollutants
from personal monitoring samples.
Air Monitoring References
Shah and Singh, ES&T, 2(12): 1381-1388, 1988. A literature survey with outdoor
concentrations of U.S. ambient air data through 1986.
36
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Kelly et al., ES&T, 28(8): 378A-387A, 1994. A comprehensive update of Shah and
Singh, 1988.
Samfield, EPA-600-R-92-025 (NTIS PB92-158468), 1992. Literature survey of U.S. and
foreign indoor concentrations through the late 1980's from residences, office buildings,
schools, other commercial buildings.
Brown et al., Indoor Air, 4:123-134, 1994. Comprehensive compilation and analysis of
U.S. and European literature, with data on residences, office buildings, schools and other
buildings.
NOPES Final Report, EPA/600/3-90/003 (NTIS PB90-152224), January 1990. The
Nonoccupational Pesticide Exposure Study is an EPA field study with indoor and outdoor
concentrations and I/O ratios from 350 samples taken in homes in Jacksonville, FL and
Chicopee-Springfield, MA.
Sheldon et al., "Indoor Pollutant Concentrations and Exposures," California Air
Resources Board, contract A833-156, final report, January 1992. A field study of indoor
and outdoor concentrations and I/O ratios from 128 homes in Woodland CA.
Shields, et al., Indoor Air, 6:2-17, 1996. A field study of indoor and outdoor
concentrations from 70 commercial buildings with different occupant densities.
Daisey et al., Atm. Environ. 28 (22): 3557-3562, 1994. A field study of indoor and
outdoor concentrations and I/O ratios from 12 office buildings in northern CA with 3
different types of ventilation systems.
37
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