8 NATIONAL EMISSION STANDARDS
| FOR HAZARDOUS AIR POLLUTANTS
AS OF MAY 1, 1980
0
8 (FIRST SUPPLEMENTAL INFORMATION
PACKET FOR UPDATING APRIL 1979
•JJ NESHAP COMPILATION,
g EPA-340/1-79-006)
o
CO
(0
c
o
'
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT
OFFICE OF GENERAL ENFORCEMENT
WASHINGTON, D.C. 20460
-------
May 1980
To holders of National Emission Standards for Hazardous Air Pollutants, A
Compilation:
This document contains those pages necessary to update the above mentioned
publication through May 1, 1980. It is only an update and must be used in
conjunction with the original compilation published by the U.S. Environmental
Protection Agency, Division of Stationary Source Enforcement in April 1979
(EPA-340/1-79-006). Copies of National Emission Standards for Hazardous Air
Pollutants, A Compilation may be obtained from:
U.S. Environmental Protection Agency
Office of Administration
General Services Division, MD-35
Research Triangle Park, North Carolina 27711
Included in this update, with complete instructions for filing, are: a new
cover and title page; all revised emission standards; the full text of all
revisions promulgated since April 1979; and all proposed standards or revisions.
Any questions, comments, or suggestions regarding this document or the pre-
vious compilation should be directed to: Standards Handbooks, Division of
Stationary Source Enforcement (EN-341), U.S. Environmental Protection Agency,
Washington, D.C., 20460.
-------
INSTRUCTIONS FOR FILING
Remove and discard the cover of this document.
Deletions
Cover dated April 1979
Title page dated April 1979
Section III, Standards:
pages III-l through 4
Section IV, Full text:
page IV-97
Section V, Proposed Amendments:
page V-i
page V-B-1 and 2
page V-F-1 and 2
Additions
New permanent cover
Title page dated May 1980
Section III, Standards:
pages 111-1 through 4
Section IV, Full text:
pages v and vi
pages IV-97 through 99
Section V, Proposed Amendments:
page V-i
page V-B-1 and 2
page V-F-1 and 2
pages V-H-1 through 26
pages V-Appendix C-l through 21
pages V-Generic-1 through 10
pages V-Radionuclides-1 through 10
Place the new Technical Report Data page and this page in the back for
future reference.
-------
8 NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
| A COMPILATION
O
O
LU
0)
O
3
O
(D
C
.0
+3
(0
*-
0)
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT
OFFICE OF GENERAL ENFORCEMENT
WASHINGTON, D.C. 20460
-------
EPA-340/1-80-006
NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
A Compilation as of May 1, 1980
by
PEDCo Environmental, Inc.
Cincinnati, Ohio 45246
Contract No. 68-01-4147
EPA Project Officers: Kirk Foster and Libby Scopino
Prepared for
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of Enforcement
Office of General Enforcement
Division of Stationary Source Enforcement
Washington, D.C. 20460
May 1980
-------
The Stationary Source Enforcement series of reports is issued by the
Office of General Enforcement, Environmental Protection Agency, to
assist the Regional Offices in activities related to enforcement of
implementation plans, new source emission standards, and hazardous
emission standards to be developed under the Clean Air Act. Copies of
Stationary Source Enforcement Reports are available - as supplies per-
mit - from the U.S. Environmental Protection Agency, Office of Admin-
istration, General Services Division, MD-35, Research Triangle Park,
North Carolina 27711, or may be obtained, for a nominal cost, from the
National Technical Information Service, 5285, Port Royal Road, Spring-
field, Virginia 22151.
-------
Title 40—Protection of Environment
CHAPTER 1—ENVIRONMENTAL
PROTECTION AGENCY
SUBCHAPTER C—AIR PROGRAMS
PART 61—NATIONAL EMISSION STAND-
ARDS FOR HAZARDOUS AIR POLLUTANTS '
Subpart A—General Provident
Sec.
61.01 Applicability.
61.02 Definitions.
61.03 Abbreviation*.
61.04 Address.
61.05 Prohibited activities.
61.06 Determination of construction or
modification.
61.07 Application for approval of construc-
tion or modification.
61.08 Approval by Administrator.
61.09 Notification of startup.
61.10 Source reporting and waiver request.
61.11 Waiver of compliance.
61.12 Emission tests and monitoring.
61.13 Waiver of emission tests.
61.14 Source test and analytical methods.
61.15 Availability of Information.
61.16 State authority.
61.17 Circumvention.7
Subpart B—National Emission Standard for
Asbestos
6120 Applicability.
8121 Definitions.
61.22 . Emission standard.
61.23 Air-cleaning..
61.24 Reporting.
61.25 Waste disposal sites.7
Subpart C—National Emission Standard for
Beryllium
81.30 Applicability.
81.31 Definitions.
61.32 Emission standard.
81.33 Stack sampling.
61.34 Air sampling.
Subpart D—National Emission Standard for
Beryllium Rocket Motor Firing
61.40 Applicability.
61.41 Definitions.
81.42 Emission standard.
61.43 Emission testing—rocket firing or pro-
pellant disposal.
61.44 Stack sampling.
61.63 Emission standard for vinyl chloride
plants.
61.64 Emission standard for polyvinyl chlo-
ride plants.
61.65 Emission standard for ethylene di-
chlorlde, vinyl chloride and poly-
vinyl chloride plants.
61.6(5 Equivalent equipment and procedures.
61.67 Emission tests.
61.68 Emission monitoring.
61.69 Initial report.
61.70 Semiannual report.
61.71 Becordkeeping.
Appendix A—Compliance Status Information.
Appendix B—Test Methods.
Method 101—Reference method for determi-
nation of partlculate and gaseous mercury
emissions from stationary sources (air
streams).
Method 102—Reference method for determi-
nation of partlculate and gaseous mercury
emissions from stationary sources (hydro-
gen streams).
Method 103—Beryllium screening method.
Method 104—Reference method for determi-
nation of beryllium emissions from sta-
tionary sources.
Method 105—Method for- determination of
mercury in wastewater treatment plant
sewage sludges.'
Method 106—Determination of vinyl chloride
from stationary sources. 2°
Method 107—Determination of vinyl chloride
of inprocess wastewater samples, and vinyl
chloride content of polyvinyl chloride
resin, slurry, wet cake, and latex samples.28
AUTHORITY: Sec. 112. 30K&) of the Clean
Air Act as amended (42 U.S.C. 7412.
7601(»)], unless otherwise noted. 28,40,47
Subpart E—National Emission Standard for
Mercury
61.60 Applicability.
61.51 Definitions.
Emission standard.
Stack sampling.
Sludge sampling.7
61.52
81.53
61.64
61.66
Emission monitoring/
Subpart A—General Provisions
§ 61.01 Applicability.
The provisions of this part apply to
the owner or operator of any stationary
source for which a standard is prescribed
under this part.
Subpart F—National Emission Standard for Vinyl
Chloride 2°
61.60 Applicability.
61.61 Definitions.
61.62 Emission standard for ethylene dl-
chloride plants.
§61.02 Definitions."
The terms used in this part are
defined in the Act or in this section as
follows:
"Act" means the Clean Air Act (42
U.S.C. 1857 et seq.).
III-l
-------
"Administrator" means the
Administrator of the Environmental
Protection Agency or his authorized
representative.
"Alternative method" means any
method of sampling and analyzing for
an air pollutant which is not a reference
or equivalent method but which has
been demonstrated to the
Administrator's satisfaction to, in
specific cases, produce results adequate
for his determination of compliance.
"Commenced" means, with respect to
the definition of "new source" in section
lll(a)(2) of the Act, that an owner or
operator has undertaken a continuous
program of construction or modification
or that an owner or operator has entered
into a contractual obligation to
undertake and complete, within a
reasonable time, a continuous program
of construction or modification.
"Compliance schedule" means the
date or dates by which a source or
category of sources is required to
comply with the standards of this part
and with any steps toward such
compliance which are set forth in a
waiver of compliance under § 61.11.
"Construction" means fabrication,
erection, or installation of an affected
facility.
"Effective date" is the date of
promulgation in the Federal Register of
an applicable standard or other
regulation under this part.
"Equivalent method" means any
method of sampling and analyzing for
an air pollutant which has been
demonstrated to the Administrator's
satisfaction to have a consistent and
quantitatively known relationship to the
reference method, under specified
conditions.
"Existing source" means any
stationary source which is not a new
source.
"Modification" means any physical
change in, or change in the method of
operation of, a stationary source which
increases the amount of any hazardous
air pollutant emitted by such source or
which results in the emission of any
hazardous air pollutant not previously
emitted, except that:
(a) Routine maintenance, repair, and
replacement shall not be considered
physical changes, and
(b) The following shall not be
considered a change in the method of
operation:
(1) An increase in the production rate,
if such increase does not exceed the
operating design capacity of the
stationary source;
(2) An increase in hours of operation.
"New source" means any stationary
source, the construction or modification
of which is commenced after the
publication in the Federal Register of
proposed national emission standards
for hazardous air pollutants which will
be applicable to such source.
"Owner or operator" means any
person who owns, leases, operates,
controls, or supervises a stationary
source.
"Reference method" means any
method of sampling and analyzing for
an air pollutant, as described in
Appendix B to this part.
"Standard" means a national emission
standard for a hazardous air pollutant
proposed or promulgated under this
part.
"Startup" means trje setting in
operation of a stationary source for any
purpose.
"Stationary source" means any
building, structure, facility, or
installation which emits or may emit
any air pollutant which has been
designated as hazardous by the
Administrator.
(Sec. 112, 301(a), Clean Air Act as amended
(42 U.S.C. 7412 and 7601(a)|)
§ 61.03 Units and abbreviations.42
Used in this part are abbreviations and
symbols of unite of measure. These are
defined as follows :
(a) System International (SI) units
of measure:
A — ampere
Hz = hertz
J = Joule
K= degree Kelvin
kg = kilogram
m = meter
m*=: cubic meter
mg = milligram = 10 > gram
mm = millimeter =10-' meter
Mg = megagram = 10* gram
mol = mole
N = newton
ng = nanogram = 10 ' grain
nm = nanometer =10-I meter
Pa= pascal
B= second
V=volt
W=watt
n=omh
lig = microgram = ) 0-° gram
(b) Other unite of measure :
•C = degree Celsius (centigrade)
elm = cubic leet per minute
cc = cubic centimeter
d=day
•p=degree Fahrenheit
ftj= square feet
IV = cubic feet
gal = gallon
In = Inch
In Hg= inches of mercury
In H.,O = Inches of water
1= liter
lb= pound
1pm = liter per minute
min = minute
ml=milllliter= 10-' liter
oz= ounces
pslg = pounds per square Inch gage
•R= degree Ranklne
»1 = mlcrollter = 10-« liter
v/v= volume per volume
yd1 = square yards
yr = year
(c) Chemical nomenclature:
Be = beryllium
Hg = mercury
HaO = water
(<3) Miscellaneous:
act = actual
avg = average
I.D. = inslde diameter
M=molar
N = normal
O.D. = outside diameter
% = percent
std = standard
(Sections 112 and 301 (a) of the Clean Air
Act, as amended [42 U.S.C. 1857cT7,
1857g
-------
(A) | Reserved |
(B) State of Alabama, Air Pollution Con-
trol Division, Air Pollution Control Commis-
sion, G45 S. McDonough Street, Montgomery,
Alabama 36104.25
(C) [Reserved]
Arizona. 30, "8
Maricopa County Department of Health
Services. Bureau of Air Pollution Control,
1825 East Roosevelt Street, Phoenix, Ariz.
85006.
Plma County Health Department, Air
Quality Control District, 151 West Congress,
Tucson. Ariz. 85701.
(E) | Reserved]
5,6,18,20,21,24,29,31,48
California.
Bay Area Air Pollution Control District,
939 Ellis Street, San Francisco, Calif. 94109.
Del Norte County Air Pollution Control
District, Courthouse, Crescent City, Calif.
95531.
Fresno County Air Pollution Control Dis-
trict, 515 South Cedar Avenue, Fresno,
Calif. 93702
Humboldt County Air Pollution Control
District, 5600 South Broadway, Eureka,
Calif. 95501.
Kern County Air Pollution Control Dis-
trict. 1700 Flower Street (P.O. Box 997). Ba-
kersfield. Calif. 93302.
Madera County Air Pollution Control Dis-
trict, 135 West Tosemite Avenue, Madera,
Calif. 93637.
Mendoclno County Air Pollution Control
District, County Courthouse, TJkiah. Calif.
94582.
Monterey Bay Unified Air Pollution Con-
trol District. 420 Church Street (P.O. Box
487). Salinas. Calif. 93901.
Northern Sonoma County Air Pollution
Control District, 3313 Chanate Road, Santa
Rosa, Calif. 95404.
Sacramento County Air Pollution Control
District, 3701 Branch Center Road, Sacra-
mento. Calif. 95827.
San Diego County Air Pollution Control
District. 9150 Chesapeake Drive. San Diego.
Calif. 92123.
San Joaquin County Air Pollution Control
District. 1601 East Hazelton Street (P.O.
Box 2009), Stockton. Calif. 95201.
Santa Barbara County Air Pollution Con-
trol District, 4440 Calle Real. Santa Bar-
bara, Calif. 93110.
Shasta County Air Pollution Control Dis-
trict. 1855 Placer Street, Redding, Calif.
96001.
South Coast Air Quality Management Dis-
trict. 9420 Telstar Avenue, El Monte, Calif.
91731.
Stanislaus County Air Pollution Control
District, 820 Scenic Drive. Modesto. Calif.
95350.
Trinity County Air Pollution Control Dis-
trict. Box AJ. Weavervule, Calif. 96093.
Ventura County Air Pollution Control
District. 625 East Santa Clara Street, Ven-
tura. Calif. 93001.
(O) State of Colorado. Colorado Air Pol-
lution Control Division. 4210 East llth Ave-
nue. Denver. Colorado 80220.'
(H) State of Connecticut, Department
of Environmental Protection. State Office
Bulldlne. Hartford, Connecticut 06115.
(I) State of Delaware (for asbestos, beryl-
lium and mercury only): Delaware Depart-
ment of Natural Resources and Environ-
mental Control, Edward Tatnall Building,
Dover, Delaware 19901.46
(J)-(K) [reserved]
(L) State of Georgia. Environmental Pro-
tection Division, Department of Natural Re-
sources, 270 Washington Street, S.W., At-
lanta, Georgia 30334.1*
(M)-(O) |Reserved|
(P) State of Indiana, Indiana Air Pollu-
tion Control Board, 1330 West Michigan
Street, Indianapolis, Indiana 46206.2*
| Reserved |
AA) |Reserved]
(BB) State of Montana. Department of
Health and Environmental Sciences. Cogs-
well Building, H«l*na. Mont. 69601.41
(CC) |reserved]
(DD) Nevada. 48
Clark County. County District Health De-
partment, Air Pollution Control Division.
625 Shadow Lane. Las Vegas, Nev. 89106.
Washoe County District Health Depart-
ment, Division of Environmental Protection.
10 Klrman Avenue, Reno, Nev. 89502.
(EE) New Hampshire Air Pollution Con-
trol Agency, Department of Health and Wel-
fare. State Laboratory Building, Hazen Drive.
Concord, New Hampshire 03301."
(PP)—State of New Jersey: New Jersey De-
partment of Environmental Protection,
John Fitch Plaza, P.O. Box 2807, Trenton,
New Jersey 08625.39
(GO) |Reserved|
(HH) New York: New York State Depart-
ment of Environmental Conservation, 50 Wolf
Road, Albany, New York 12233, attention:
, ,
Division of Air Resources.8
(II) North Carolina Environmental Man-
agement Commission, Department of Natural
and Economic Resources, Division of Envi-
ronmental Management, P.O. Box 27687, Ra-
leigh. North Carolina 27611. Attention: Air
Quality Section. 32
(,7J) State of North Dakota, State De-
partment of Health, State Capitol, Bismarck,
North Dakota 58501.27
(kk) Ohio
Montgomery County: Regional Air
Pollution Control Agency, Montgomery
County Combined General Health
District 451 West Third Street. Dayton*
Ohio 45402.
Clarke, Darke, Greene, Miami and
Preble Counties [except for all
information required under §. 61.22 (dj
and (e)]: Montgomery County Combined1
General Health District. 451 West Third
Street. Day ton, Ohio 45402.53
(LL) (Reserved]
(MM) State of Oregon, Department of
Environmental Quality, 1234 SW Morrison
Street, Portland. Oregon 97205. W
(NN) (a) Commonwealth of Pennsylvania
(except for City of Philadelphia and Alle-
gheny County) Pennsylvania Department of
Environmental Resources, Bureau of Air
Quality and Noise Control. Post Office Box
2063, Harrisburg, Pennsylvania 17120.
(b) City of Philadelphia. Philadelphia De-
partment of Public Health Air Management
Services, 801 Arch Street, Philadelphia. Penn-
•svlvanla 19107. 35
(OO) State of Rhode Island, Department
of Environmental Management. 83 Park
Street, Providence, R.I. 0290850
(PP) State of South Carolina, Office of En-
vironmental Quality Control, Department
of Health and Environmental Control, 2600
Bull Street. Columbia, South Carolina 29201?
(QQ)-I RR) (Reserved)
(SS) State of Texas, Texas Air Con-
trol Board, 8520 Shoal Creek Boule-
vard. Austin, Texas 78758.51
(TT) [reserved]
(UU) State of Vermont. Agency of Envi-
ronmental Protection, Box 489, Montpelier,
Vermont 05602.33
(VV) Commonwealth of Virginia. Virginia
State Air Pollution Control Board, Room
1106, Ninth Street Office Building, Richmond.
Virginia 23219.15
(WW) (1) Washington; State of Washing-
ton, Department of Ecology, Olympla, Wash-
ington 98504.
(11) Northwest Air Pollution Authority,
207 Pioneer Building, Second and Pine
Streets, Mount Vernon, Washington 98273.
(Ill) Puget Sound Air Pollution Control
Agency, 410 West Harrison Street, Seattle,
Washington 98119.
(Iv) Spokane County Air Pollution Con-
trol Authority, North 811 Jefferson, Spokane,
Washington 99201.
(v) Yaklma County Clean Air Authority.
County Courthouse. Yaklma, Washington
98901. 4,10
(vl) Olympic Air Pollution Control Au-
thority, 120 East State Avenue, Olympla,
Washington 98501.
(vll) Southwest Air Pollution Control Au-
thority, Suite 7601 H, NE Hazel Dell Avenue.
Vancouver, Washington 98665.13
(XX) [Reserved]
(YY) Wisconsin—Wisconsin Department
of Natural Resources, P.O. Box 7921, Madi-
son. Wisconsin 53707.57
(ZZ) (Reserved]
(AAA) |Reserved]
(BBB)—Commonwealth of Puerto Rico
Commonwealth of Puerto Rico Environ-
mental Quality Board. P.O Box 11785. Sa:i-
turce.P.R. 00910.43
(CCC) U.S. Virgin Islands: U.S. Virgin
Islands Department of Conservation and
Cultural Affairs, P.O. Box 578, Charlotte
Amalie, St. Thomas, U.S. Virgin Islands
00801. 22
iSecs. 101. 110, 111. 112 and 301 of the Clean
Air Act, as amended, 42 U.S.C. 1857, 1857c-
5. 6, 7 and 1857g.)
III-3
-------
§ 61.05 Prohibited activities.
(a) After the effective date of any
standard prescribed under this part, no
owner or operator shall construct or mod-
ify any stationary source subject to such
standard without first obtaining written
approval of the Administrator In accord-
ance with this subpart, except under an
exemption granted by the President
under section 112(c)(2) of the act.
Sources, the construction or modification
of which commenced after the publica-
tion date of the standards proposed to
be applicable to such source, are subject
to this prohibition.
(b) After the effective date of any
standard prescribed under this part, no
owner or operator shall operate any new
source in violation of such standard ex-
cept under an exemption granted by the
President under section 112(c) (2) of the
act.
(c) Ninety days after the effective date
of any standard prescribed under this
part, no owner or operator shall operate
any existing stationary source In viola-
tion of such standard, except under a
waiver granted by the Administrator In
accordance with this subpart or under
an exemption granted by the President
under section 112(c) (2) of the act.
(d) No owner or operator subject to
the provisions of this part shall fall to
report, revise reports, or report source
test results as required under this part.
§ 61.06 Determination of construction
or modification.
Upon written application by an owner
or operator, the Administrator will make
a determination of whether actions taken
or Intended to be taken by such owner
or operator constitute construction or
modification or the commencement
thereof within the meaning of this part.
The Administrator will within 30 days
of receipt of sufficient Information to
evaluate an application, notify the owner
or operator of his determination.
§ 61.07 Application for approval of
construction or modification.
(a) The owner or operator of any new
source to which a standard prescribed
under this part is applicable shall, prior
to the date on which construction or
modification is planned to commence, or
within 30 days after the effective date
in the case of a new source that already
has commenced construction or modifi-
cation and has not begun operation, sub-
mit to the Administrator an application
for approval of such construction or
modification. A separate application shall
be submitted for each stationary source.
(b) Each application shall Include:
(1) The name and address of the ap-
plicant.
(2) The location or proposed location
of the source.
(3) Technical information describing
the proposed nature, size, design, operat-
ing design capacity, and method of oper-
ation of the source, Including a descrlp-.
tion of any equipment to be used for
control of emissions. Such technical In-
formation shall Include calculations of
emission estimates in sufficient detail to
permit assessment of the validity of such
calculations.
§ 61.08 Approval by Administrator.
(a) The Administrator will, within 30
days of receipt of sufficient Information
to evaluate an application under § 61.07,
notify the owner or operator of approval
or intention to deny approval of con-
struction or modification.
(b) If the Administrator determines
that a stationary source for which an
application pursuant to § 61.07 was sub-
mitted will, if properly operated, not
cause emissions in violation of a stand-
ard, he will approve the construction or
modification of such source.
(c) Prior to denying any application
for approval of construction or modifica-
tion pursuant to this section, the Admin-
istrator will notify the owner or operator
making such application of the Admin-
istrator's intention to issue such denial,
together with:
(1) Notice of the Information and
findings on which such intended denial
is based, and
(2) Notice of opportunity for such
owner or operator to present, within such
time limit as the Administrator shall
specify, additional information or argu-
ments to the Administrator prior to final
action on such application.
(d> A final determination to deny any
application for approval will be In writ-
Ing and will set forth the specific grounds
on which such denial is based. Such final
determination will be made within 60
days of presentation of additional infor-
mation or arguments, or 60 days after
the final date specified for presentation.
if no presentation is made.
(e) Neither the submission of an ap-
plication for approval nor the Admin-
istrator's granting of approval to con-
struct or modify shall:
(1) Relieve an owner or operator of
legal responsibility for compliance with
any applicable provision of this part or
of any other applicable Federal, State.
or local requirement, or
(2) Prevent the Administrator from
implementing or enforcing this part or
taking any other action under the act.
§ 61.09 Notification of startup.
(a) Any owner or operator of a source
which has an initial startup after the
effective date of a standard prescribed
under this part shall furnish the Admin-
istrator written notification as follows:
(1) A notification of the anticipated
date of Initial startup of the source not
more than 60 days nor less than 30 days
prior to such date.
(2) A notification of the actual date
of initial startup of the source within 15
days after such date.
(Ssc. 11
-------
Reference Page
44 FR 31596, 5/31/79 Proposed Amendment to Defini-
tion of "Commenced"
52 44 FR 55173, 9/25/79 National Emission Standards for 98
Hazardous Air Pollutants; General Provisions; Defini-
tions
44 FR 58642, 10/10/79 - Proposed Policy and Procedures
for Identifying, Assessing, and Regulating Airborne
Substances Posing a Risk of Cancer
44 FR 58662, 10/10/79 - Advance Notice of Proposed
Generic Standards
44 FR 61620, 10/26/79 - Proposed Policy and Procedures
for Identifying, Assessing, and Regulating Airborne
Substances Posing a Risk of Cancer; Informal Public
Hearings
53 44 FR 65399, 11/13/79 - National Emission Standards 99
for Hazardous Air Pollutants; General Provisions
44 FR 70196, 12/6/79 - Proposed Policy and Procedures
for Identifying, Assessing, and Regulating Airborne
Substances Posing a Risk of Cancer; Informal Public
Hearings
44 FR 76737, 12/27/79 - Notice of Addition of Radio-
nuclides to List of Hazardous Air Pollutants
45 FR 6960, 1/31/80 - Proposed Policy and Procedures
for Identifying, Assessing, and Regulating Airborne
Substances Posing a Risk of Cancer; Public Comment
Period
54 45 FR 13074, 2/28/80 - Delegation of Authority to the 99
State of Maryland
45 FR 13476, 2/29/80 - Proposed Policy and Procedures
for Identifying, Assessing, and Regulating Airborne
Substances Posing a Risk of Cancer; Informal Public
Hearings
45 FR 21346, 4/1/80 - Conoco Chemicals Company;
Approval of NESHAPS Application
45 FR 25828, 4/16/80 - Proposed Policy and Procedures
for Identifying, Assessing, and Regulating Airborne
Substances Posing a Risk of Cancer; Advance Notice
of Proposed Generic Standards; Public Comment Period
iV-v
-------
Reference Page
45 FR 26660, 4/18/80 - Proposed Emission Standards
for Benzene Emissions from Maleic Anhydride Plants
IV-vi
-------
50
PART 61—NATIONAL EMISSION
STANDARDS FOR HAZARDOUS AIR
POLLUTANTS
Delegation of Authority for State of
Rhode Island
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Amendment.
SUMMARY: The delegation of au-
thority to the State of Rhode Island
for national emissions standards for
hazardous air pollutants (NESHAPS)
was made on March 31, 1978. This
amendment, which adds the address of
the Rhode Island Department of Envi-
ronmental Management, reflects this
delegation. A notice announcing this
delegation is published today in the
FEDERAL REGISTER.
EFFECTIVE DATE: October 16, 1978.
FOR FURTHER INFORMATION
CONTACT:
John Courcier. Air Branch. EPA
Region I, Room 2113, JFK Federal
Building, Boston, Mass. 02203, 617-
223-4448.
SUPPLEMENTARY INFORMATION:
Under the delegation of authority for
the national emission standards for
hazardous air pollutants (NESHAPS)
to the State of Rhode Island on March
31, 1978, EPA is today amending 40
CFR 61.04, Address, to reflect this del-
egation. A notice announcing this dele-
gation is published today elesewhere
in this part of the FEDERAL REGISTER.
The amended §61.04, which adds the
address of the Rhode Island Depart-
ment of Environmental Management
to which all reports, requests, applica-
tions, submittals, and communications
to the Administrator pursuant to this
part must also be addressed, is set
forth below.
The Administrator finds good cause
for foregoing prior public notice and
for making this rulemaking effective
immediately in that it is an adminis-
trative change and not one of substan-
tive content. No additional burdens
are imposed on the parties affected.
The delegation which is reflected by
this administrative amendment was ef-
fective on March 31, 1978, and it
serves no purpose to delay the techni-
cal change of this addition of the
State address to the Code of Federal
Regulations.
This rulemaking is effective immedi-
ately, and is issued under the authori-
ty of section 112 of the Clean Air Act,
as amended, 42 U.S.C. 7411.
Date: September 18, 1978.
WILLIAM R. ADAMS, Jr.
Regional Administrator,
Region I.
RULES AND REGULATIONS
Part 61 of chapter I. title 40 of the
Code of Federal Regulations is amend-
ed as follows:
In §61.04 paragraph (b) is amended
by adding subparagraph (OO) to read
as follows:
§61.04 Address.
(OO) State of Rhode Island. Department
of Environmental Management, 83 Park
Street, Providence, R.I. 02908
CFR Doc. 78-29106 Filed 10*13-78; 9:49 am]
51
PART 61— NATIONAL EMISSION
STANDARDS POR HAZARDOUS AIR
POLLUTANTS
Delegation of Authority to State of
Texas
AGENCY: Environmental Protection
Agency.
ACTION: Final rule.
SUMMARY: This action intends Sec-
tion 61.4, Address, to reflect the dele-
gation of authority for the National
Emission Standards for Hazardous A1r
Pollutants (NESHAPS) to the State of
Texas.
EFFECTIVE DATE February 7. 193«.
POR FUKTHEK INFORMATION
CONTACT:
James Veach. Enforcement Division.
Region 8. Environmental Protection
Agency, First International Build-
ing. 1201 Elm Street. Dallas. Texas
75270. telephone <214) 767-2760.
SUPPLEMENTARY INFORMATION:
A notice announcing the delegation of
authority is published elsewhere in
the Notice Section in this issue of the
FEDERAL REGISTER. These amendments
provide that all reports and communi-
cations previously submitted to the
Administrator, will now be sent to the
Texas Air Control Board. 8520 Shoal
Creek Boulevard, Austin. Texas, in-
•tead of EPA's Region 6.
As this action is not one of substan-
tive content, but is only an administra-
tive change, public participation was
judged unnecessary.
(Sections 112 and 30 Ma) of the Clean Air
Act; Section 4(a> of Public Law »l-W4. «4
Btat. 1685; Section 2 of Public Law 90 148.
81 Stat. 504 [42 V£.C. 7412 niirl 7SC'i«OJ).
Dated: November 15, li '
Regional Ad ;nin . . ' .- aio r,
.<•:•;•&< f>n 6.
Part 61 of Chapter 1, Tills 40, Code
of Federal Regulations, is amended as
follows:
In §61.04, paragraph (b> ;SS) Is
amended as follows:
{61.04 Address.
(b) • • •
(SS) State of Texas. Texas Air Con-
trol Board, 8520 Shoal Creek Boule-
vard, Austin, Texas 78758.
CFR Doc. 79-4228 Filed 2-6-79; 8:45 am]
KDEKAl RfOOraR, VOL «4, NO. TO
WiOWSOAT, fWtUARY T,
FEDERAL REGISTER, VOL 43, NO. MO—MONDAY, OCTOBER 16, 1971
IV-97
-------
Federal Register / Vol. 44. No. 187 / Tuesday, September 25. 1979 / Rules and Regulations.
52
40 CFR Part 61
[FRL 1328-1]
National Emission Standards for
Hazardous Air Pollutants; General
Provisions; Definitions
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final Rule.
SUMMARY: This document makes some
editorial changes and rearranges the
definitions alphabetically in Subpart
A—General Provisions of 40 CFR Part
61. An alphabetical list of definitions
will be easier to update and to use.
EFFECTIVE DATE: September 25,1979.
FOR FURTHER INFORMATION CONTACT:
Mr. Don R. Goodwin, Director, Emission
Standards and Engineering Division
(MD-13), U. S. Environmental Protection
Agency, Research Triangle Park, North
Carolina 27711, telephone (919) 541-
5271.
SUPPLEMENTARY INFORMATION: The
"Definitions" section (§ 61.02) of the
General Provisions of 40 CFR Part 61
now lists definitions by paragraph
designations. Due to the anticipated
increase in the number of definitions to
be added to the General Provisions in
the future, continued use of the present
system of adding definitions by
paragraph designations at the end of the
list could become administratively
cumbersome and could make the list
difficult to use. Therefore, paragraph
designations are being eliminated and
the definitions are rearranged
alphabetically. New definitions will be
added to § 61.02 of the General
Provisions in alphabetical order
automatically.
Since this rule simply reorganizes
existing provisions and has no
regulatory impact, it is not subject to the
procedural requirements of Executive
Order 12044.
Dated: September 19.1979.
Edward F. Tuerk,
Acting Assistant Administrator for Air, Noise,
and Radiation.
40 CFR 61.02 is amended by removing
all paragraph designations and by
rearranging the definitions in
alphabetical order as follows:
§61.02 Definitions,
The terms used in this part are
defined in the Act or in this section as
follows:
"Act" means the Clean Air Act (42
U.S.C. 1857etseq.).
"Administrator" means the
Administrator of the Environmental
Protection Agency or his authorized
representative.
"Alternative method" means any
method of sampling and analyzing for
an air pollutant which is not a reference
or equivalent method but which has
been demonstrated to the
Administrator's satisfaction to, in
specific cases, produce results adequate
for his determination of compliance.
"Commenced" means, with respect to
the definition of "new source" in section
lll(a)(2) of the Act, that an owner or
operator has undertaken a continuous
program of construction or modification
or that an owner or operator has entered
into a contractual obligation to
undertake and complete, within a
reasonable time, a continuous program
of construction or modification.
"Compliance schedule" means the
date or dates by which a source or
category of sources is required to
comply with the standards of this part
and with any steps toward such
compliance which are set forth in a
waiver of compliance under § 61.11.
"Construction" means fabrication,
erection, or installation of an affected
facility.
"Effective date" is the date of
promulgation in the Federal Register of
an applicable standard or other
regulation under this part.
"Equivalent method" means any
method of sampling and analyzing for
an air pollutant which has been
demonstrated to the Administrator's
satisfaction to have a consistent and
quantitatively known relationship to the
reference method, under specified
conditions.
"Existing source" means any
stationary source which is not a new
source.
"Modification" means any physical
change in, or change in the method of
operation of, a stationary source which
increases the amount of any hazardous
air pollutant emitted by such source or
which results in the emission of any
hazardous air pollutant not previously
emitted, except that:
(a) Routine maintenance, repair, and
replacement shall not be considered
physical changes, and
(b) The following shall not be
considered a change in the method of
operation:
(1) An increase in the production rate,
if such increase does not exceed the
operating design capacity of the
stationary source;
(2) An increase in hours of operation.
"New source" means any stationary
source, the construction or modification
of which is commenced after the
publication in the Federal Register of
proposed national emission standards
for hazardous air pollutants which will
be applicable to such source.
"Owner or operator" means any
person who owns, leases, operates,
controls, or supervises a stationary
source.
"Reference method" means any
method of sampling and analyzing for
an air pollutant, as described in
Appendix B to this part.
"Standard" means a national emission
standard for a hazardous air pollutant
proposed or promulgated under this
part.
"Startup" means th^ setting in
operation of a stationary source for any
purpose.
"Stationary source" means any
building, structure, facility, or
installation which emits or may emit
any air pollutant which has been
designated as hazardous by the
Administrator.
(Sec. 112, 301(a). Clean Air Act as amended
(42 U.S.C. 7412 and 7601(a)))
|FR Doc. 79-20768 Filed 9-24-78: 8:45 am)
IV-98
-------
Federal Register / Vol. 44, No. 2?.0 / Tuesday, November 13, 1979 / Rules and Regulations
53
ENVIRONMENTAL PROTECTION
AGENCY
40CFRPart61
[FRL 1356-2]
National Emission Standards for
Hazardous Air Pollutants; General
Provisions
AGENCY: U.S. Environmental Protection
Agency.
ACTION: Final rule.
SUMMARY: This amendment institutes an
address change for the implementation
of technical and administrative review
and enforcement of the National
Emission Standards for Hazardous Air
Pollutants. The notice announcing the
delegation of authority is published
elsewhere in this issue of the Federal
Register.
EFFECTIVE DATE: Effective November 13,
1979.
ADDRESSES: All reports, requests.
applications and communications
required pursuant to 40 CFR 61.10 for the
Counties in Ohio listed below are to be
submitted to the Regional Air Pollution
Agency, Montgomery County Combined
General Health District, 451 West Third
Street. Dayton. Ohio 45402. Copies of
these reports shall also be submitted to
U.S. EPA, Region V, Enforcement
Division, 230 South Dearborn Street,
Chicago, Illinois 60604.
FOR FURTHER INFORMATION CONTACT:
Debra Marcantonio. USEPA Air
Programs Branch, U.S. Environmental
Protection Agency, Region V, 230 South
Dearborn Street, Chicago, Illinois 60604.
(312) 886-6048.
SUPPLEMENTARY INFORMATION: The
Regional Administrator finds good cause
for foregoing prior public notice and for
making this rulemaking effective
immediately in that it is an
administrative change and not one of
substantive content No additional
substantive burdens are imposed on. the-
parties.affected. The delegation-, became
effective September 11,1979* Therefore,,
it serves.no-purpose to. delay the
technical change of this addition of an
address to the Code of Federal
Regulations. This rulemaking is-effective
immediately and is issued under
authority of Section 112 of the Gleam Air
Act. (42 U.S.C. 7412)'
Section 61.04 of Part 61 of Chapter I.
Title 40 of the Code of Federal
Regulations is amended by adding a
new paragraph (b)(kk) as follows;
Subpart A—General Provisions
§ 61.04 is amended us follows:
§ 61.04 Address.
*****
(b) * * *
(kk) Ohio
Montgomery County: Regional Air
Pollution Control Agency, Montgomery
County Combined General Health
District, 451 West Third Street, Daytonv
Ohio 45402.
Clarke. Darke, Greene, Miami and
Preble Counties [except for all
information required under § 61.22 fdj
and (e)|: Montgomery County Combined1
General Health District, 451 West Third
Street. Dayton, Ohio 45402.
• * * • •
Dated: November 2,1979.
John McGuire,
Regional Administrator.
[FR Doc 79-34832 Tiled 11-8-7* S4Saro|.
Federal Register / Vol. 45, No. 41 / Thursday. February 28. 1980 /
Rules and Regulations
54
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 61
[FRL 1411-5]
National Emission Standards for
Hazardous Air Pollutants; Delegation
of Authority to the State of Maryland
AGENCY: Environmental Protection
Agency.
ACTION: Final Rulemaking.
SUMMARY: Pursuant to the delegation of
authority for National Emissions
Standards for Hazardous Air Pollutants
[NESHAPS] to the State of Maryland on
October 9,1979, EPA is today amending
40 CFR 61.04, Address to reflect this
delegation.
EFFECTIVE DATE: February 28,1980.
FOR FURTHER INFORMATION CONTACT:
Thomas Shiland, (215) 597-7915 EPA,
Region III (Curtis Building). 6th &
Walnut Streets, Philadelphia,
Pennsylvania 19106.
SUPPLEMENTARY INFORMATION: A Notice
announcing this delegation is published
today elsewhere in the Federal Register.
The amended 61.04 which adds the
address of the Maryland Bureau of Air
Quality to which all reports, requests,
applications, submittals, and
communications to the Administrator
pursuant to this part must also be
addressed, is set forth below.
The Administrator finds good cause
for foregoing prior public Notice and for
making this rulemaking effective
immediately in that it is an
Administrative change and not one of
substantive content. No additional
burdens are imposed on the parties
affected. The delegation which is
reflected by the Administrative
amendment was effective on October 9,
1979, and it serves no purpose to delay
the technical change of this address to
the Code of Federal Regulations.
This rulemaking is effective"
immediately, and is issued under the
authority of Section 112 of the Clean Air
Act, as amended, 42 U.S.C. § 7412.
Dated: January 28,1980.
R. Sarah Compton,
Director, Enforcement Division.
Part 61 of Chapter I, Title 40 of the
Code of Federal Regulations is amended
as follows:
1. In § 61.04 paragraph (b) is amended
by revising Subparagraph V to read as
follows:
§61.04 Address
* * . * * *
(b) * * *
(V) State of Maryland, Bureau of Air
Quality and Noise Control, Maryland State
Department of Health and Mental Hygiene,
201 West Preston Street, Baltimore, Maryland
21201.
(FR Doc. 80-6197 Filed 2-27-80; 8:45 am)
IV-99
-------
V. Proposed Revisions
Section
F
H
Appendix C
Generic
Radionuclides
Standard
Asbestos Standard for the Production and
Use of Crushed Stone
Vinyl Chloride Revisions
Benzene from Maleic Anhydride Plants
Policy and Procedures for Identifying,
Assessing and Regulating Airborne Sub-
stances Posing a Risk of Cancer
Generic Standards
Addition of Radionuclides to List of
Hazardous Air Pollutants
V-i
-------
ENVIRONMENTAL
PROTECTION
AGENCY
NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
ASBESTOS
SUBPART B
-------
IPK©I?©SED HULES
[40CFRPart61 ]
[FRL 788-2]
NATIONAL EMISSION STANDARDS FOR
HAZARDOUS AIR POLLUTANTS
Development of Asbestos Standard for ths
Production and Use of Crushed Stone
AGENCY: Environmental Protection
Agency.
ACTION: Advance notice of proposed
rulemaking.
SUMARY: The Environmental Protec-
tion Agency (EPA) is undertaking a
study of the crushed stone industry to
determine the extent to which quarrying
operations are being conducted in areas
containing serpentinite rock deposits, to
determine the asbestos content of the
rock being mined, and to determine
whether the public is being exposed to
asbestos from various uses of the rock.
Serpentinite rock from a quarry location
in Rockville, Maryland, has been found
to contain significant quantities of
asbestos, and the use of unbound (with-
out a coating or binding agent) crushed
stone produced from this rock on crushed
stone roads has been shown to result in
high concentrations of asbestos in the
air near these roads. If EPA determines
that the production and use of asbestos-
containing serpentinite rock is causing
asbestos emissions proximate to the
public in a number of locations, stand-
ards will be proposed in the FEDERAL
REGISTER under Section 12 of the Clean
Air Act.
DATE: The information requested in this
notice must be submitted on or before
January 10, 1977.
ADDRESSEE: Information in response
to this Advance Notice of Proposed Rule-
making should be submitted to the Emis-
sion Standards and Engineering Division
(MD-13), Environmental Protection
Agency, Research Triangle Park, N.C.
27711, Attention: Mr. Ron R. Goodwin.
FOR FURTHER INFORMATION CON-
TACT:
Mr. Don R. Goodwin, Director, Emission
Standards and Engineering Division (MD-
13), Environmental Protection Agency, Re-
search Triangle Park, N.C. 27711, 919-541-
5271.
SUPPLEMENTARY INFORMATION: It
is well documented that airborne asbes-
tos fibers are related to human disease,
specifically pulmonary fibrosis, carcino-
ma, and pleural mesothelioma. The
quantification of the health risk asso-
ciated with specific airborne concentra-
tions, fiber dimensions, and chemical
composition of the fibers, however, is in-
exact. The problem of estimating the
magnitude of this risk to human health
is further complicated by the 20- to 40-
year latency period between the onset of
exposure and the appearance of disease.
In addition, cancer-causing agents ap-
pear to be "non-threshold" pollutants
so that no level can be set which is en-
tirely safe from cancer risk. Consequent-
ly. EPA believes that exposure to air-
borne asbestos should be reduced to the
greatest extent feasible. A hazardous
emission standard currently exists for
several sources of asbestos. S&e 40 CFR,
Partei.SubpartB.
In early 1977. EPA tests indicated that
dust from the crushed stone produced
by a Rockville, Maryland, rock quarry
contained from 0.25 to 0.70 weight per-
cent chrysotile asbestos. Analyses of air
samples taken by EPA and Mt. Sinai
School of Medicine near several sites in
Montgomery County. Maryland, where
unbound crushed stone from this quarry
was in use, revealed ambient air concen-
trations of chrysotile asbestos as high as
17 million fibers per cubic meter and as
high as 6400 nanograms per cubic meter,
depending on distance from the road and
prevailing traffic conditions. These con-
centrations are as much as 1000 times
higher than those usually found in ur-
ban and metropolitan areas.
It is clear from the air monitoring
data that several uses of unbound
cruched stone from the Rockville. Mary-
land, quarry can cause elevated concen-
trations of asbestos in the air. The Mary-
land State Bureau of Air Quality and
Noise Control, the Montgomery County-
Department of Environmental Protec-
tion, and the Montgomery County De-
partment of Transportation are taking
measures to control asbestos emissions
from roads and other public areas which
were surfaced with crushed stone from
the Rockville quarry. Warning signs
have been posted in parks and school-
yards where asbestos-containing crushed
stone is in use and in many cases the
rock has been removed. Dust suppres-
sants and liquid asphalt has been ap-
plied to the roads where the most severe
dust problems existed. The Montgomery
County Department of Transportation
has issued a moratorium on the use" of
crushed stone from the Rockville quarry
and has notified all public users of the
rock and the largest private users that
the crushed stone they have used is from
the Rockville quarry and may contain
asbestos. Maryland has also found that
the rock in several other quarries in the
State contains asbestos and, as a result,
is developing regulations to restrict the
future use of crushed stone containing
asbestos in certain applications and to
control emissions from certain areas
which have been surfaced with asbestos-
containing crushed stone in an unbound
form.
An analysis of geological survey maps
prepared by the United States Geological
Survey indicates that the Rockville,
Maryland, rock quarry and a number of
other rock quarries in the United States,
produce crushed stone from serpentinite
rock deposits. Geologists agree that most
serpentinite rock deposits contain at least
a small percentage of chrysotile asbestos.
This leads EPA to believe that a number
of crushed stone plants in the United
States may be producing asbestos-con-
taining crushed stone similar to that pro-
duced by the Rockville, Maryland, rock
quarry. Other types of rock deposits may
also contain asbestos; however, the cor-
relation between other rock types and the
presence of asbestos is not as clear.
EPA is therefore beginning a study to
determine the extent of the problem of
asbestos emissions that may exist from
the use of crushed stone produced from
serpentinite rock. This study is being
conducted in response to requests from
officials of Montgomery County, Mary-
land ; two Congressmen from the State of
Maryland; and the Environmental De-
fense Fund. The purpose of this study Is
to determine whether EPA should de-
velop a Federal standard to limit asbestos
emissions from this source. In this study,
EPA will identify serpentinite rock quar-
ries within the United States, collect and
analyze rock samples from these quar-
ries, determine whether elevated levels
of asbestos in the air are occurring due
to the use of crushed stone containing
various asbestos contents, and determine
how widespread the problem appears to
be.
Currently both the State and local
agencies have indicated their intention
to take appropriate measures to control
this problem in Maryland. If EPA's Study
determines that this problem does not
warrant work on proposal of a Federal
standard, EPA assistance will be avail-
able to local agencies on a case-by-case
basis to deal with this problem.
EPA is requesting that all interested
persons submit factual information con-
cerning crushed stone produced' from
serpentinite rock, particularly informa-
tion on its production, sale, and use in
various applications; its asbestos con-
tent; and public exposure to ambient air
asbestos emissions resulting from its use
in various applications. It is expected
that such information will assist EPA in
determining whether to formulate any
regulations.
Dated: November 3, 1977.
DOUGLAS M. COSTLE,
Administrator.
[FB Doc.77-32666 Filed ll-9-77;8:45 am)
BEGISTEQ, VOl. 4J, WO. 817—THURSDAY, NOVEMBER 10. 1077
V-B-2
-------
ENVIRONMENTAL
PROTECTION
AGENCY
NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
VINYL CHLORIDE
SUBPART F
-------
EGWOKOWMENTAIL
AGENCY
[FRL 728-6]
VBNYL CHLOKIESE
Air Pollutants
AGENCY: Environmental Protection
Agency.
ACTION: Proposed rule.
SUMMARY: The proposed amendments
are being made to the vinyl chloride
standard which has promulgated Octo-
ber 21, 1976, and would apply to new
and existing ethylene dlchloride, vinyl
chloride, and polyvinyl chloride plants.
The standard and the proposed amend-
ments implement the Clean Air Act and
are based on the Administrator's deter-
mination that vinyl chloride is a hazard-
ous air pollutant. The intended effect of
the proposed amendments is to require
improved effectiveness of control tech-
nology at existing plants, impose more
stringent emission limits on new sources,
and prohibit an emission increase within
the vicinity of an existing source due to
6he construction of a new source.
DATES: Comments must be received on
or before August 1, 1877.
ADDRESSES : Comments should be sub-
mitted (preferably m triplicate) to the
Emission Standards and Engineering
Division, Environmental Protection
Agency, Research Triangle Park, North
Carolina, Attention: Mr. Don R. Good-
win.
All public comments received may be
Inspected and copied at the Public In-
formation Reference Unit (EPA Li-
brary), Room 2922, 401 M Street, SW.,
Washington, D.C.
FURTHER INFORMATION CON-
TACT:
Don R. Goodwin, Emission Standards
and Engineering Division, Environ-
mental Protection Agency, Research
Triangle Park, North Carolina 27711,
Telephone No. 919-688-8146, ext. 271.
SUPPLEMENTARY INFORMATION:
BACKGROUND
On October 21, 1976, EPA promulgated
a standard for vinyl chloride under the
authority of section 112(b) (1) (B) of the
Clean Air Act, as amended (41 FR
46561). The standard applies to ethyl-
ene dlchloride, vinyl chloride, and poly-
vinyl chloride plants.
On November 19. 1976, the Environ-
mental Defense Fund (EDF) petitioned
the United States Court of Appeals for
the District of Columbia Circuit to review
the standard. Motions to Intervene were
subsequently filed on behalf of the So-
ciety of the Plastics Industry, Inc., the
Goodyear Tire and Rubber Company and
Air Products and Chemicals, Inc., and
were granted by order of the Court on
January 18, 1977. On March 24, 1977,
EDF and EPA moved to dismiss the
proceedings in view of & settlement
agreement requiring EPA to take certain
additional actions. These include & re-
otatsment af EPA's policy for regulating
carcinogens under section 112 of the
Clean Air Act; the proposal of esnend-
' ments which would require increased
efficiency of existing control equipment,
require more stringent control at aew
sources, and prohibit increases In emis-
sions within the vicinity of an existing
source due to new construction; and the
initiation of a review of the vinyl chlo-
ride standard three years after the pro-
mulgation of the amendments.
ZERO EMISSION GOAL
The vinyl chloride standard has been
criticized for allegedly placing unwar-
ranted emphasis on technological rather
than health considerations. Although
EPA disagrees with this criticism, it
seems appropriate to restate EPA's ap-
proach to the regulation of carcinogens
In general and under Section 112 of the
Clean Air Act, and to explain how the
vinyl chloride standard and the pro-
posed amendments are consistent with
this approach and with the protection
of public health.
On May 25, 1978, EPA published In-
terim procedures and guidelines for
health risk and economic Impact assess-
ments of suspected carcinogens (41 FR
21402), which define EPA's approach to
regulatory action for suspect carcino-
gens. As indicated in that publication,
there are two steps involved in the deci-
sion-making process with regard to the
regulation of a potential carcinogen. Al-
though different EPA statutory author-
ities impose different requirements, in
general two decisions must be made with
regard to each potential carcinogen. The
first decision is whether a particular sub-
stance constitutes a cancer risk. The
second decision is what regulatory ac-
tion, if any, should be taken to reduce
that risk.
In deciding whether a cancer risk
exists, EPA will consider a substance a
presumptive cancer risk when it causes
a statistically significant excess Incidence
of benign or malignant tumors in hu-
mans or animals. In the case of vinyl
chloride, EPA evaluated all available
data and concluded that a cancer risk
exists. In deciding how and whether to
regulate, EPA examined section 112 of
the Clean Air Act. Section 112 of the Act
requires that emission standards be set
"at the level which in the judgment of
the Administrator provides an ample
margin of safety to protect the public
health from such hazardous air pollut-
ants." This requirement appears to as-
sume that each pollutant regulated will
have a threshold level of effects below
which no health effects will occur. As
explained in the documentation for the
current standard (40 FR 59532, Decem-
ber 24, 1975; 41 FR 46560, October 21,
1976), it has not been possible to deter-
mine if there Is a threshold level of
effects for vinyl chloride and it is not
certain that such a threshold may be
determined in the near future. In the
absence of strong evidence to the con-
trary, then, the only level of vinyl chlo-
ride which would appear to be absolutely
protective of health is zero, which may
be achievable only by tanning vinyl chlo-
ride emissions completely. That, in turn.
would require closing the entire industry.
As explained hi the eaiUer rulemaklng it
is not clear that Congress would have
Intended this result, so instead EPA re-
quired the lowest level achievable using
technological means. (See 40 FR 59534
and 41 FR 46562).
In order to insure that the standard
continues to approach the only level of
emissions which is known to be abso-
lutely protective of health, namely aero
emissions, EPA is proposing amendments
which require more efficient use of exist-
ing control technology at existing plants
and more effective controls at new
plants, and which encourage technology
to reach this goal without banning vinyl
chloride.
MORE STRINGENT STANDARDS FOR ESISTEJG
SOURCES
EPA is proposing amendments which
would require sources presently subject
to a 10 ppm emission limit to reduce
emissions to 5 ppm within three years of
promulgation of the amendments. The
affected sources include ethylene dichlo-
ride purification; vinyl chloride forma-
tion and purification; reactors, strippers;
mixing, weighing, and holding contain-
ers; monomer recovery systems; anfi
fugitive emissions which have been cap-
tured in accordance with the existing
regulation.0 If the owner or operator of
a, source believed that a control system
would not be capable of meeting the 5
ppm limit, he would be able to request
that the Administrator approve an in-
terim emission limit for that source.
Such requests would have to be made one
year before the compliance date. In re-
questing an interim emission limit, ttes
owner or operator would have to submifc
supportive data and meet with SPA to
discuss his particular problems in attain-
ing compliance. The meeting would tea
announced in the FEDERAL REGISTER and
any Interested party would be allowed to
attend and submit written or oral com-
ments. If an interim emission limit were
granted to the source, the required emis-
sion level would be specified in a written
notification from EPA and in the FEB-
ERAL REGISTER. Each source granted on
interim emission limit would be reviewed
every three years to determine whether
emissions could be reduced to 5 ppm, o?
at least to a lower interim emission limit.
In proposing the reduction from 10 to
5 ppm, it Is not EPA's Intent that a con-
trol system which has been installed to
°As an explanatory note, paragraph (b) of
3 61.65 contains nine fugitive emission regu-
lations. For several of these, the fugltlva
emissions are required to be captured and
ducted to a control device meeting 19 ppm.
According to the proposed amendments, tSio
emissions from this control device wouM
have to ba reduced to 8 ppm In the same woy
any other source currently required to meat
10 ppm would have to do. Bather than in-
corporating both the 5 and 10 ppm omlealoa
limits In each paragraph in 961.65(b), o
separate paragraph (c) containing -these
emission limits is being added to 6 61.65. All
the other paragraphs to (b) are croso-
referenced in paragraph (o) •
UE©ISTER, VOL. 42, NO, S06—YHUBSDAV, JHJME 2,
V-F-2
-------
ENVIRONMENTAL
PROTECTION
AGENCY
NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
BENZENE EMISSIONS FROM
MALEIC ANHYDRIDE PLANTS
SUBPART H
-------
Fsdaral Register / Vol. 45, No. 77 / Friday. April 18.1§80 / Proposed Rules
[PRL 137S]
Ctoftlonal Emission Standard for
(Xlasardeus Air Pollutants; Borosert©
(Emissions From
A@EWCV: Environmental Protection
Agency (EPA).
ACT8SM: Proposed rule and notice of
public hearing.
Y: The proposed standard
would limit benzene emissions from
maleic anhydride plants. Emissions from
existing sources would have to be
reduced to 0.30 kilogram of benzene per
100 lilograms of benzene fed to the
reactor. No detectable benzene
emissions would be allowed from new
sources, this can be done by substituting
another feedstock, such as n-butane, for
benzene. Benzene emissions during a
control system malfunction could not
exceed those that .would occur if the
benzene feed were shut off to all
reactors as soon as practicable after the
malfunction began. A new test Method
110 is proposed for the determination of
benzene emissions from stationary
sources.
The proposed standard implements
the Clean Air Act and is based on the
Administrator's determination of June 8,
1977, that benzene presents a significant
carcinogenic risk to human health as a
result of air emissions from one or more
stationary source categories and is ,
therefore a hazardous air pollutant. The
intent of the standard is to protect the
public health with an ample margin of
safety.
A public hearing will be held to
provide interested persons an
opportunity for oral presentation of
data, views, or arguments concerning
both the listing of benzene as a
hazardous air pollutant, which affects
all benzene-emitting stationary sources,
and the proposed standard for maleic
anhydride plants.
©flTES: Comments. Comments must be
received on or before June 17, 1980.
Public Hearing. A public hearing will
be held on May 20, 1980 beginning at
9:00 a.m.
Request to Speak at Hearing. Persons
wishing to present oral testimony must
contact EPA by May 13, 1980.
ABSCESSES: Comments. Comments on
the health effects of benzene and the
listing of benzene as a hazardous air
pollutant should be submitted (in
duplicate, if possible) to: Central Docket
Section (A-130), Attention: Docket No.
OAQPS 79-3, Part I, U.S. Environmental
Protection Agency, 401 M Street, S.W.,
Washington, D.C. 20460. Comments on
the proposed maleic anhydride standard
should be submitted to: Central Docket
Section (A-130), Attention: Docket No.
OAQPS 79-3, Part II, same address.
Public Hearing. The public hearing
will be held at Olde Colony Motor Lodge
North Washington and 1st St..
Alexandria, Va. Persons wishing to
present oral testimony should notify Ms.
Shirley Tabler, Standards Development
Branch (MD-13), U.S. Environmental
Protection Agency. Research Triangle
Park, North Carolina 27711, telephone
number (919) 541-5421.
Background Information Document.
The background information documents
for the proposed standard are contained
in the docket and may be obtained from
the U.S. EPA library (MD-35), Research
Triangle Park, North Carolina 27711,
telephone number (919) 541-2777. Please
refer to Benzene Emissions from Maleic
Anhydride Plants—Background
Information Document for Proposed
Standard (EPA-450/3-8O-O01a),
Assessment of Health Effects of
Benzene Germane to Low Level
Exposures, Assessment of Human
Exposures to Atmospheric Benzene, and
Carcinogen Assessment Croup's Report
on Population Risk to Ambient Benzene
Exposures.
Docket. Docket No. OAQPS 79-3,
Parts I and II, containing supporting
information used in developing the
proposed standard, is available for
public inspection and copying between
8:00 a.m. and 4:00 p.m., Monday through
Friday, at EPA's Central Docket Section,
Room 2903B, Waterside Mall, 401 M
Street SW., Washington, D.C. 20460. A
reasonable fee may be charged for
copying.
F0H FURTHER IMF@RB)ATI©N gOMTAOT:
Mr. Don R. Goodwin, Director, Emission
Standards and Engineering Division
(MD-13), U.S. Environmental Protection
Agency, Research Triangle Park, North
Carolina 27711, telephone number (919)
541-5271.
Supplementary Information
Notice is hereby given that under the
authority of Section 112(b)(l)(B) of the
Clean Air Act, as amended, the
Administrator is proposing a national
emission standard for benzene
emissions from maleic anhydride plants.
The proposed standard is consistent
with EPA's proposed Policy and
Procedures for Identifying, Assessing,
and Regulating Airborne Substances
Posing a Risk of Cancer (see 44 FR
58642). As prescribed by section
112(b)(l)(A) of the Act, the proposal of
this standard was preceded by the
Administrator's determination that
benzene is a hazardous air pollutant as
defined in section 112(a)(l) of the Act.
Accordingly, the Administrator revised
the list of hazardous air pollutants on
June 8,1977 by adding benzene (42 FR
29332).
A Background Information Document
has been prepared that contains
information on the manufacture and
processing of maleic anhydride, the
available control technologies for
benzene emissions, and an analysis of
the environmental, energy, economic,
and inflationary impacts of regulatory
options. Information on the health
effects of benzene is contained in
documents prepared by or for EPA,
entitled the Assessment of Health
Effects of Benzene Germane to Low
Level Exposure, the Assessment of
Human Exposures to Atmospheric
Benzene, and the Carcinogen
Assessment Group's Report on
Population Risk to Ambient Benzene
Exposures. The information contained in
these documents is summarized in this
preamble. All references used for the
information contained in the preamble
can be found in one of the four
documents.
Proposed Standard
The proposed standard would apply
to all maleic anhydride production units
that process more than 500 megagrams
(550 tons) of maleic acid, maleic
anhydride, or both per year.
The proposed standard would limit
the quantity of benzene that could be
discharged into the atmosphere from
each maleic anhydride production unit
•for which construction commenced on or
before April 18,1980 to 0.30 kilogram of
benzene per 100 kilograms (0.30 Ib/ICO
Ib) of benzene fed to the reactor(s). Any
maleic anhydride production unit for
which construction or modification
commenced after April 18,1980 would
be limited to no detectable benzene
emissions as measured with the
proposed Test Method 110; this standard
could be met by using a feedstock such
as n-butane rather than benzene for
making maleic anhydride.
For existing sources, emissions in
excess of the numerical emission limit
would not be allowed during routine
startup and shutdown of a plant.
Emissions in excess of the numerical
emission limit that are caused by control
system failures would be allowed only if
the plant owner or operator
demonstrated to the Administrator's
satisfaction that the emissions were
unavoidable. Equipment failures that
V-H-2
-------
/ Vol.--35, No. 77 / Friday, April 18,
could have been prevented by proper
design, operation, and maintenance
would be considered avoidable.
Emissions in excess of the numerical
emission limit that are due to
unavoidable control system failures
could be no greater than the total
uncontrolled mass emissions that weald
occur during a plant (shutdown. Maleic
anhydride planto using benzene ao Q
feedstock would have to install
continuouc emission monitors for
benzene and report tfcs occurrence of
emissions in excess of the numerical
emission limit within 10 days of each
occurrence.
Existing sources would have to
comply with the standard within SO days
of its effective date, unless Q waiver of
compliance were obtained. A waiver of
compliance could be granted by the
Administrator fair rco more than 2 years
from the promulgation date.
Summary of Health, Environmental,
Energy, amd {Economic Impacts
The proposed standard would affect
as many as eight existing plants that
produce maleic acid, maleic anhydride,
or both as an end product.'The standard
would also apply to one plant that
produces maleic acid as an intermediate
in the production of fumaric acid.
Because EPA has only recently become
aware of this plant, it is not included in
the health, environmental, energy, and
economic impacts discussed in this
section, in the remainder of the
preamble, or in the Background
Information Document. This plant would
be covered by the proposed standard,
however, because available information
indicates that there is no technical
reason to exclude it. The process,
emission sources, and appropriate
control technology appear to be the
same as for the other plants that
produce maieic acid, maleic anhydride,
or both as an end product. Information
on this plant is being collected and will
be included in the evaluations of health,
environmental, energy, and economic
impacts at the time of promulgation.
Because newly constructed or
modified maleic anhydride production
units could emit no detectable quantities
of benzene, potential future benzene
emissions from these sources would be
prevented. Mo additional benzene health
effects would result from the expansion
of existing plants or the construction of
new plants.
The proposed standard would require
uncontrolled benzene emissions from
existing maleic anhydride production
units to be reduced by approximately ©7
percent. The proposed standard would
reduce nationwide benzene emissions
from the plants that produce Enoleic
anhydride as an end product when they
are operating at full capacity from about
5,600 megagrems (8XHJO tons) per year to
600 megagrams (6BQ tons) per yea?. As a
result of this emission reduction, there
would be an order of magnitude
reduction in the estimated incidence of
leukemia deaths for the 10 million
people estimated to live within 2D
kilometera (12.5 miles) of existing maleic
anhydride plants.
A more significant health impact than
reduction in incidence would bs the
reduction in risk to the most exposed
individuals living near maleic anhydride
plants. This risk reduction would occur
because the magnitude of the incidence
is a function of the number of people
exposed and the level of control at
various plants as well 08 the risk factor.
In the case of maleic anhydride plants,
the?e ere only a few plants, many of
which already have some controls.
' Thus, the greatest health benefit of the
standard is for the population at highest
risk; i.e., those people living close to one
of the several uncontrolled plants. The
risk to the most exposed group due to
emissions from process vents occurs 500
meters (550 yards) from the everage-
sized plant, and the proposed standard
would reduce it by two orders of
magnitude, it is estimated that 4,000
people live within 500 meters and 2,000
people live within ICO meters (1M yards)
of maleic anhydride plants. In addition,
a reduction in other health effects
associated with benzene exposure (such
as cytopenia, splastic anemia, and
chromosomal aberrations) may be
expected.
The control systems likely to be used
to meet the standard (incineration or
carbon adsorption) would also reduce
emissions of other hydrocarbons that
may be toxic and that contribute to
oxidanf formation and associated
environmental problems. Furthermore, if
incineration were used, carbon
monoxide emissions would be reduced.
The reduction in national benzene
emissions achieved with the proposed
standard would be obtained with
minimal adverse impacts on other
aspects of the environment. These
adverse impacts could include small
increases in nitrogen oxide and sulfur
oxide emissions into the air. There could
be small increases in solid wastes and
benzene in wastewater. Compliance
with the proposed standard would
increase national energy consumption
by an estimated 310,000 gigajoules (GJ/
yr) (50,000 barrels of fuel oil equivalent
per year) by 1980.
The capital investment required by
the domestic maleic anhydride industry
to comply with the proposed standard
would be about §8.8 million over the 2-
year period from 1®78 to IB®). The total
annualieed costs of the industry due to
control system installation would
increase by about 02.5 million per year
by 1683, and maleic anhydride prices
would increase overall by about 1.2
percent. Em addition, daring control
system malfunctions, production levels
may be decreased to achieve
compliance with the standard. This
could cause between 15 and 42 hours of
lost pi-eduction per year. For a typical
plant with on annual capacity of 22,700
megagrams (50,C&0,GOT pounds), there
would be an estimated cost of 81,000 to
$1,500 per hour of lost production. The
costs of foregone production are difficult
tc quantify for the entire industry due to
variations in plant design and operation
and in market parameters. Furthermore,
the proposed standard may result in one
plant closure.
Several activities by Federal agencies
and a number of recent studies have
increased public concern about
exposure to benzene via inhalation. In
September of 1976 and again in
December of 1978, the National Institute
for Occupational Safety and Health
(NIOSH) recommended to the
Occupational Safety and Health
Administration (OSHA) that the Federal
occupational exposure limit for benzene
be reduced from Q 10 parts per million
(ppm) level for an 8-hour workday to 1
ppm. In January of 1977, OSHA issued
nonenforceable guidelines to industry
urging compliance with the NIOSH
recommendations. In May, following
receipt of a NIOSH study demonstrating
that workers exposed to benzene are at
considerable risk to leukemia, OSHA
issued a temporary emergency standard
that reduced the occupational limit from
10 to 1 ppm for an 8-hour daily exposure,
OSHA promulgated that standard on
February 10,1978.
Following these actions by OSHA and
NIOSH and in response to a petition
from the Environmental Defense Fund
(EOF), the Administrator announced in
the June 8,1977 Federal Register (42 FR
29332) his decision to list benzene as a
hazardous air pollutant under Section
112 of the Clean Air Act. A "hazardous
air pollutant" is defined as an "... air
pollutant to which no ambient air
. quality standard is applicable and
which . . . may reasonably be
anticipated to result in an increase in
mortality or an increase in serious
irreversible, or incapacitating reversible
illness."
Numerous occupational studies
conducted over the past 50 years
V-H-3
-------
:ar / Vol. 45, No. 77 / Friday, April 18, 1980 / Proposed Rules
provide evidence of health hazards
resulting from prolonged inhalation
exposure to benzene. Benzene has been
recognized since 1900 as a toxic
substance capable of causing acute an.'.
chronic effects. Benzene attacks the
hematopoietic system, especially the
bone marrow, and its toxicity is
manifested primarily by alterations in
the level of the formed elements in the
circulating blood (red cells, white cells,
and platelets). The degree of severity
ranges from mild and transient episodes
to severe and fatal disorders. The
mechanism by which benzene produces
its toxic effects, although under
investigation, is still unknown.
The adverse effects on the blood-
forming tissues, including leukemia,
have been documented in studies of
workers in a "variety of industries and
occupations, including the manufacture
or processing of rubber, shoes,
rotogravure, paints, chemicals and, more
recently, natural rubber cast film. These
studies include single-case reports,
cross-sectional studies, and
retrospective studies of morbidity and
mortality among a defined cohort of
workers industrially exposed to
benzene.
Based on a review of the entire set of
studies taken as a whole, the
Administrator concluded that benzene
exposure is causally related to the
induction of a number of blood
disorders including leukemia (a cancer
of the blood-forming system).4 Although
the studies whiph form the basis for this
conclusion involve occupational
exposure to benzene at levels higher
than those found in the ambient air, the
Administrator has "made a generic
determination that, in view of the
existing state of scientific knowledge,
prudent public health policy requires
that carcinogens be considered for
regulatory purposes to pose some finite
risk of cancer at any exposure level
above zero" (44 FR 58646). Based on its
widespread use, emissions of benzene
into the ambient air have been
determined to result in significant
human exposure. For these reasons
benzene emissions may reasonbly be
anticipated to result in one or more
serious effects that can be expected to
lead to an increase in mortality or an
increase in serious, irreversible or
incapacitating, reversible illness.
Therefore, the Administrator concluded
that benzene satisfies the definition of
"hazardous air pollutant" under Section
112 of the Clean Air Act.
* Benzene has also been shown to be causally
related to various cytopenias (decreased levels of 0
formed element in the circulating blood), aplastic
anemia (a nonfunctioning bone marrow), and
potentially inheritable chrcmooomal aberrationo.
The Administrator considered the
alternative of taking no further action
and relying instead on the OSHA
standard for benzene and volatile
orji.mc compound (. OC) control under
the State Implementation Plans (SIP's).
Reliance on the OSHA standard was
rejected because the current OSHA
standard stipulates a level of benzene
that cannot be exceeded in the work
place. This work place standard is not
expected to result in the control of
emissions from stacks within maleic
anhydride plants, such as those for the
product recovery absorber and refining
system.
VOC emissions, as potential
precursors of photochemical oxidants,
are now being regulated under State
Implementation Plans (SIP's). The goal
of SIP regulations for VOC's is to effect
statewide compliance with the National
Ambient Air Quality Standard (NAAQS)
for photochemical oxidants. Because
benzene is a VOC, SIP regulations for
reducing VOC's from maleic anhydride
plants would also reduce benzene
emissions. However, a particular State
may not need to control maleic
anhydride plants to meet that standard
or it may not need to control VOC's to
the same extend as may be appropriate
for benzene in light of its hazardous
nature. Consequently, the Administrator
rejected reliance on SIP's for control of
benzene emissions from maleic
anhydride plants.
Furthermore, use of the Toxic
Substances Control Act was rejected as
a mechanism for controlling benzene
emissions from maleic anhydride plants
because the Clean Air Act provides a
more direct, expeditious route for
regulating these sources. The Toxic
Substances Control Act could be used,
however, as a possible mechanism for
placing a maximum limit on the amount
of benzene in gasoline and for regulating
benzene levels in solvents.
Selection of Maleic Anhydride Plants for
Regulation
Benzene is emitted from mobile
sources, the gasoline marketing system,
chemcial manufacturing plants,
petroleum refineries, coke byproduct
plants, benzene storage and handling,
and chemical plant fugitive emission
sources. Of all benzene emissions,
currently 80 percent of the nationwide
benzene emissions are estimated to be
from mobile sources and 20 percent from
stationary sources. However, only
stationary sources are subject to
regulation under Section 112 of the
Clean Air Act. Therefore, while benzene
emissions from mobil sources are of
concern from an agencywide regulatory
standpoint, the proposed standards for
maleic anhydride plants were developed
as a result of establishing priorities for
the stationary sources above.
Maleic anhydride process vents were
selected as a stationary source category
of benzene emissions for regulation for a
combination of two reasons. First,
maleic anhydride plants account for 35
percent of all stationary source
emissions of benzene and are by far the
largest source of benzene emissions in
the chemical manufacturing industry.
Second, estimates of cancer incidence
and risk to the most exposed population
have been calculated for stationary
source categories of benzene emissions.
All these source categories were then
ranked from high to low, first for
incidence and then for risk to the most
exposed population. When both
incidence and risk were weighed
together, maleic anhydride process
vents ranked as one of the higher
priority source categories for regulation.
Selection of Sources Within Maleic
Anhydride Plants to be Regulated
Maleic anhydride is produced
primarily by benzene oxidation and to a
lesser extent b^ n-butane oxidation. A
small amount is also recovered as a
byproduct from phthalic anhydride
manufacture. Benzene is not used in the
n-butane oxidation process or in
phthalic anhydride manufacture and is
not believed to be emitted to the
atmosphere from these processes. The
standard technically applies to all
maleic anhydride plants. However,
because no benzene is believed to be
emitted from sources that do not use
benzene as a feedstock, these source are
not subject to the testing, continuous
monitoring, or excess emissions
reporting requirements included in the
standard.
The proposed standard would apply
to plants that produce maleic acid,
maleic anhydride, or both as an
intermediate, as well as to plants that
produce maleic acid, maleic anhydride,
or both as an end product. The economic
and environmental impact analyses for
the proposed standard include only
those plants that produce maleic acid.
maleic anhydride, or both as an end
product because EPA only recently
learned about the existence of one plant
that produces maleic acid as an
intermediate in the manufacture of
fumaric acid. Although the plant was not
included in the assessment of the
environmental and economic impacts of
the proposed standard, it is covered by
the proposal because available
information indicates that there is no
technical reason, to exclude it. The
process, emission sources, and
appropriate control technology appear
V-H-4
-------
Risgistar / Vol. 45, No. 77 / Friday. April 18, 1080 / Proposed Rules
to be the same as for the other plants
that produce maleic acid, maleic
anhydride, or both as an end product.
This plant will be included in the
assessment of the impacto of the
standard at the time of promulgation.
The sources of potential benzene
emission to the atmosphere from plants
using the benzene oxidation proceos end
the quantity of benzene each emits at an
average or model plant [producing
22.700 Mg/yr [50,000,000 Ib/yr] of maleic
anhydride) are:
Source
Emfocionrote
<0>/hr)
Product recovery t&sorbsr
Refining system
Storage and handling
Fugitive _ _
ieo
1.8
0.8
420
4
1.8
(These emission rates are based on
the industry average benzene
conversion rate in the reactor of 94.5
percent.)
The proposed standard would cover
the maleic anhydride production unit,
which includes the reactor; the product
recovery absorber, which emits over 98
percent of the benzene emissions; and
the refining system. The product
recovery absorber consists of equipment
in which a gas stream from the reactor
containing maleic anhydride or maleic
acid is contacted with an absorbent
liquid to recover the maleic anhydride,
maleic acid, or both as a mixture. The
refining system consists of equipment
used to keep refining columns, single- or
multiple-effect evaporators,
crystallizers, and other unit separation
process equipment under negative '
pressure. The refining system emits only
small quantities of benzene; however,
because if has a small flow rate, it can
easily be controlled by the same control
device used for the product recovery
absorber with minimal additional
expense.
Fugitive, secondary, and storage and
handling benzene emissions are being
considered for regulation by generic
benzene standards. These generic
benzene standards would apply to a
large number of similar chemical
industries and processes that emit
benzene. This approach would be taken
to reduce the number of standards
required to cover essentially the same
benzene emission sources in several
different industries. Consequently,
fugitive, secondary, and storage and
handling emissions are not covered in
this standard.
The proposed standard would cover
any facility that uses benzene to
manufacture at least 500 megagrams
(550 tons) of maleic acid, maleic
anhydride, or both annually. This
number wao picked as a cutoff to
differentiate between commercial-sized
plants and laboratory facilities. Existing
commercial-sized plants produce more
thon 500 •'• '-jagrams (550 tons) each
yem.
Eslectiosi of RogulaScci-y Options
Three alternative emission control
techniques were examined for maleic
anhydride plants. The first of these
techniques, conversion to n-butane as
the feedstock, represents the use of a
substitute. The other two alternatives,
control of benzene by recovery or
oxidation through the use of carbon
adsorption or incineration, represent
add-on controls.
The n-butane oxidation process uses
n-butane in place of benzene as the
feedstock in producing maleic
anhydride. Because the process is
believed to have no benzene emissions,
conversion of benzene-based plants to
use n-butane as the feedstock can be
considered a control technique that
potentially eliminates benzene
emissions. The benzene and n-butane
processes appear similar. In both
processes, the feedstock enters a reactor
where it is oxidized with the aid of a
catalyst to curde maleic anhydride,
which is then passed through a series of
refining columns and collected as a
finished product. Conversion to n-
butane as a feedstock would require at a
minimum the installation of a different
catalyst and the installation of new
feedstock storage tanks where n-butane
can be kept as a liquid under pressure or
as a refrigerated liquid at atmospheric
pressure. Little information is available,
however, to indicate what, if any, other
process changes might also be required
or what their impacts would be.
Carbon adsorption and incineration
can achieve various levels of control,
depending on the design and operation
of the devices. Factors influencing the
efficiency of carbon adsorption systems
for benzene control at maleic anhydride
plants include: (1) the relative humidity
of the incoming waste gas stream, (2) the
presence of other organic compounds
that may interfere with benzene
adsorption or that may form polymeric
materials on the carbon beds, (3) the
temperature of the beds during
adsorption, (4) the efficiency of the
steam regeneration, (5) the dryness of
the bed, (6) the carbon bed size, (7) the
number of beds, and (B) the cycle time.
A well-designed carbon adsorption unit
at a maleic anhydride plant should have
a preheater to lower the relative
humidity of the incoming gases since
they are normally saturated with water
and should use a caustic scrubber for
removing most of the other organics in
the gases. After regeneration, the carbon
bed, which is hot and saturated with
water, should be cooled and dried by
blowing organic-free air through it. The
cooling air should be recycled to the
carbon adsorption system. The bed size,
number of beds, and cycle times can be
varied to achieve the desired removal
efficiency.
Two maleic anhydride plants
currently use carbon adsorption. The
system at one maleic anhydride plant
for which data are available is reported
to achieve a benzene removal efficiency
ranging from 85 to 95 percent. This
system does not use an organic-free air
stream to cool and dry the beds after
regeneration with steam. Immediately
after regeneration, the waste gas stream
containing benzene is directed to the hot
bed. Consequently, until the bed cools
and dries, benzene removal efficiency is
low. This partially accounts for the
relatively low overall benzene removal
efficiency.
Factors influencing the efficiency of
an incinerator are temperature, degree
of mixing, and residence time in the
combustion chamber. For maleic
anhydride plants, a knockout demister
tank is required ahead of the incinerator
to prevent entrained liquid droplets from
reaching the burner area. Supplemental
fuel is required to maintain the
necessary combustion temperature.
Supplemental combustion air may also
be required, if the incoming gas stream
is not preheated. A temperature of 870°
C (1,600°F) is required to ensure
complete combustion of the waste gas,
although it is possible that greater than
89 percent benzene removal can be
obtained at lower temperatures in some
cases.
Two maleic anhydride plants in the
United States that use benzene as a
feedstock control the product recovery
absorber emissions with combusiton.
The first plant routes the waste gas
stream from the product recovery
absorber through a waste heat boiler.
This system is reported by the plant's
owner to achieve a benezene removal
efficiency as high as 99 percent. The
combustion temperature is about 1,090°
C (2,000° F), and the residence time is 0.8
second. A waste heat boiler, however, is
only a viable control technique when
there is a need for the additional steam.
Maleic anhydride plants generally
produce a surplus of steam.
The second plant controls the product
recovery abosorber waste gas stream
with a thermal incinerator that operates
at 760° C (1.400°F) and has a residence
time of 0.7 second. Emission test data
indicate that a sustained benzene
V-H-5
-------
m I Vol. «5. No. 77 / Friday. April 18, 1980 / Proposed Rules
removal efficiency of about 97 percent is
achievable.
Engineering experience with similar
applications for the control of volatile
organic chemicals indicates that a
thermal incinerator can be designed and
operated with a benzene removal
efficiency of greater than 88 percent.
Limited information is available
concerning direct-flame afterburners
used on maleic anhydride production
facilities, but there are several cases in
which streams similar to the product
recovery absorber and refining system
vent gas have been controlled at very
high efficiencies. In one case, data
reported for toluene indicate a removal
efficiency of 99.9 percent at 763° C
(1,410° F) and a residence time of 0-21
second. A second facility incinerates a
toluene-xylene fume at 7®0° C CLWO° F)
and is reported to achieve a destruction
efficiency of 99.1 percent A tfaird
installation also reports a removal
efficiency greater than £9.8 percent at
760° C (1,400° F) for an organic stream
considered as toluene. In addition, a
review of several studies of incinerators
indicates that combustion efficiencies
less than 95 percent were achieved.
except in one case, at temperatures of
730° C (1,350° F) or lower. Conversely,
efficiencies greater than 99 percent were
achieved at temperatures of 760° C
(1,400° F) or higher.
Finally, recent laboratory studies on
the thermal incineration of benzsne
show high benzene destruction
efficiencies, which depend on
temperature. Instrumentation with a
benzene detection limit of two parts per
millon by volume (ppmv) showed no
residual benzene in gas streams
following incineration at temperatures
above 790° C (1,450° F) with residence
times as low as 0.03 second.
The available information from the
'preceding paragraphs indicates that a
conservatively designed and well-
operated incinerator would be expected
to consistently achieve at least £3
percent control of benzene at an
operating temperature of about 870° C
(1,600° F) and a residence time of 0.5
second.
These three emission control
techniques for reducing benzene
emissions from maleic anhydride plants
lead to the following regulatory options:
(1) Sf percent benezene control, based
on (he best demonstrated level of
control that is now being achieved at an
exacting maleic anhydride plant and that
is universally applicable to any existing
plant;
(2) 69 percent benzene control, based
on technology transfer; and
(3) No detectable benzene emissions,
based on conversion to n-butane as a
feedstock.
Little information Is available on what
would be required to convert each
existing benzene-based plant to an n-
butane-based plant, or what the
consequences of such a conversion
would be. Based on the limited
informaiton available, it appeara that
considerable effort continues to bs
directed towards dsveloping n-butane
technology, particukriy the catalyst
Only toe existing Amoco plant was
originally designed to use n-butane as £
feedstock. Problems associated with
converting existing plants to n-butane
include: (1) potentially signficant
reductions in maleic anhydride
production whan currant n-batane
catalyst technology is combined with
equipment designed for benzene as the
feed stock, and (2) omatisfactory
operation resulting from equipment
changes needed in the refining system.
Because of uncertainties concerning the
feasibility of converting each existing
source to n-butane and the impacts of
such conversion, this approach is not
considered a viable regulatory option for
existing sources based on best available
technology (considering environmental
energy, and economic impacts) (BAT).
The use of n-butane as a feedstock,
however, is considered a viable
regulatory option for new sources.
Because the industry was operating at
only 56 percent of capacity in 1978, few
new sources are expected to be built
until the mid-lBSO's. This allows time for
continued development of the n-butane
process. Furthermore, a new plant could
be designed to use n-butane and would
therefore not encounter the potential
problems associated with conversion. In
fact, one company has recently
announced the construction of a new
-------
/ Vol. 45. No: 77 I Friday, April 18, 1080 / Proposed Rules
the model plant—including the product
recovery absorber refining system; and
fugitive, storage, and handling emission
sources—are estimated to be 1,500 Mg/
yr (1,850 tons/yr) at 59 percent of
capacity and 2,600 Mg/yr (3,080 tons/yr)
at full capacity. The total benzene
emissions for the model plant under
Option 1 are estimated to be 77 Mg/yr
(85 tons/yr) when the plant is operating
st 59 percent of capacity and 110 Mg/yr
(120 tons/yr) when the plant is operating
at 100 percent of capacity. The benzene
emissions under Option 2 are estimated
to be 49 Mg/yr (50 tons/yr) at 58 percent
of capacity and 60 Mg/yr (69 tons/yr) at
full capacity. The estimates for Options
1 and 2 assume that fugitive and storage
emissions are uncontrolled.
A dispersion model was used to
project ambient benzene concentrations
attributable to uncontrolled emissions,
emissions regulated to meet Option 1,
and emissions regulated to meet Option
2. The projected maximum annual
overage benzene cpncentration for an
uncontrolled model maleic anhydride
plant occurred at a distance of 0.3
kilometer (330 yards) from the plant and
was 0.01 ppmv. For either Option 1 or
Option 2, the maximum benzene
concentration occurred at 0.1 kilometer
(110 yards) from the plant and was O.CCS
ppmv under either option.
If an incinerator were used to comply
with a standard based on either Option
1 or 2, it would emit nitrogen oxides
(NOJ, less carbon monoxide (CO) than
an uncontrolled plant, possibly some
particulates, and sulfur oxides (SOJ.
Under either option, emissions of NOn
are roughly estimated to be increased by
about 10 Mg/yr (11 tons/yr) at a model
maleic anhydride plant. If all plants
were to install incinerators, nationwide
emissions of NOn would be increased by
an estimated 65 Mg/yr (72 tons/yr). If an
incinerator were used to control
benzene, it would also control CO
emissions from the process and their
would be a net reduction rather than an
increase in CO emissions.
It natural gas were used as the
auxiliary fuel for incineration, the
increase in participate and SO8
emissions would also be negligible, it is
possible, however, that gas would be
unavailable for incineration in some
locations. In these locations, fuel oil
could be used, and depending upon the
type of fuel oil, there could be an
increase in SOn and participate
emissions. Assuming, for example, a fuel
oil of 0.3 percent by weight of sulfur
were used, SOa emissions at a typical
maleic anhydride plant would increase
by about 5 Mg/yr (5.5 tons/yr) under
Option 1 and about 15 Mg/yr (17 tons/
yr) under Option 2. If all plants were to
install incinerators burning fuel oil of
thio oulfur content, nationwide
omissions of SOn would be increased by
about 50 Mg/yr (55 tons/yr) under
Option 1 and about 110 Mg/yr (120 tons/
yr) under Option 2. These adverse air
impacts are considered small in light of
(he alternative of unregulated benzene
omissions.
Incineration does not lead to any
wastewater effluents requiring disposal.
Consequently, there would be no
adverse water pollution impacts
associated with a standard based on
either Option 1 or 2, if incineration were
used to comply with the standard.
A wastewater stream containing
benzene is associated with using a
carbon adsorption system. However, the
organic load of the wastewater from
carbon adsorption is less than 10
percent of the total organic liquid waste
load from a model maleic anhydride
plant. The wastewater stream from a
carbon adsorption system could be
[recycled to the product recovery
absorber or treated along with the other
plant effluent since the organic liquid
effluent from a carbon adsorber system
is similar in character to the other waste
liquid streams from the process. The
organic liquid effluent resulting from the
use of a carbon adsorption system is
therefore estimated to have an
insignificant incremental impact on
water pollution.
Maleic anhydride plants typically
have a wastewater treatment facility to
handle process effluents containing
organics. Benzene is biodegradable and
could be handled in such & treatment
plant. However, this wastewater could
become a secondary source of benzene
emissions, if the benzene were to
evaporate to the atmosphere during
(treatment. If all the benzene were to
evaporate, the benzene emissions from
wastewater at a model plant would be
about 40 Mg/yr (44 tons/yr). The
possibility of regulating air emissions
from wastewater treatment is scheduled
for future study.
The only potential impact on solid
waste disposal associated with either
Option 1 or 2 is the handling of spent
carbon from carbon adsorption systems.
Typically, rather than being disposed of
in a landfill, spent carbon is reclaimed
and regenerated at special facilities. If,
however, spent carbon were disposed of
in a landfill; die amount of solid waste
. from this source would be about 7,400
kg/yr (3.4 tons/yr) and 7.600 kg/yr (3.5
tons/yr) from a model maleic anhydride
plant using this control technique to
achieve compliance with a standard
based on Options 1 and 2, respectively.
As mentioned previously, however, it is
likely that the spent carbon would be
reclaimed, and there would be no
impact on solid waste disposal under
their Option 1 or 2.
Energy Impact
Although process heaters are required
at startup and during some operations,
the heat released from the oxidation of
benzene and other compounds in the
reactor during normal operations
produces a small energy surplus of
about 15 kilojoules (kj) per kilogram (6.5
Btu/lb) of maleic anhydride produced.
For the model plant with a production
capacity of 22,700 Mg/yr (25,000 tons/
yr], the energy surplus would be about
340 gigajoules (GJ) (322,000 Btu) per
year.
Carbon adsorption requires energy in
the form of steam to desorb the benzene
from- the carbon and electrial energy for
pumps and other equipment. The energy
requirement for a model maleic
anhydride plant using carbon adsorption
to meet a standard based on Option 1
would be about 85,000 GJ/yr (80.6 x 10°
Btu/yr) and to meet a standard based on
Option 2, it would be about 80,000 GJ/yr
(85.3 X ID" Btu/yr).
Thermal incineration requires energy
directly as fuel. If a typical maleic
anhydride plant used thermal
incineration to meet a standard based
on Option 1, the energy required would
be about 45,000 GJ/yr (42.7 x 10s Btu/yr)
and to meet Option 2, it would be about
05,000 GJ/yr (SO.OX 10s Btu/yr),
assuming 50 percent heat recovery.
Assuming that half the existing maleic
anhydride plants that required
additional controls used carbon
adsorption and that half used thermal
incineration to comply with a standard
based on Option 1, the impact of the
standard would be an increase in
national energy consumption of about
310.000 GJ/yr (293.8 X108 Btu/yr). This is
equivalent to about 50,000 barrels of fuel
oil per year. The impact of a standard
based on Option 2 under the same
assumption would be an increase in
national energy consumption of about
525,000 GJ/yr (497.6 XlO8 Btu/yr). This
equivalent to about 85,000 barrels of fuel
oil per year. These impacts are
considered small; compared to U.S. oil
imports in 1978 of 3.0 billion barrels of
oil, they are negligible.
Economic Impact
Control equipment costs were
developed from a baseline of current
controls. When costs were developed, id
was assumed that existing control
systems that are currently not meeting
She level of the standard under Option 1
or Option 2 could not be upgraded and
would have to be replaced with new
V-H-7
-------
I Vol. 45. No. 77 / Friday. April 18, 1680 / Proposed Rules
control systems. Capital cost estimates
were also based on control equipment
designed to handle the waste gases from
the product recovery absorber and
refining system when operating at full
production capacity. Cost estimates are
considered accurate to ±30 percent.
For a model uncontrolled maleic
anhydride plant with a capacity of
22,700 Mg/yr (25.CDO tons/yr),
compliance with a standard based on
Option 1 would require a capital cost
between $1.18 and $1.40 million, and
compliance with & standard basdd on
Option 2 would require a capital cost of
about $1.22 to Sl-44 million. The range in
these estimates reflects the difference
between using carbon adsorption and
incineration as the control technique.
These costs would increase the total
capital expenditures of the average
company that manufactures maleic
anhydride by less than 1 percent
However, it should be noted that maleic
anhydride sales generally represent less
than 1 percent of the total sales for the
average company that manufactures
maleic anhydride.
Total annualized costs would be
increased by about §354,000 to g442,000
per year for the model plant meeting a
standard based on Option 1, depending
on whether incineration or carbon
adsorption were used as the control
technique. If these costs-were passed
forward completely, the price of maleic
anhydride would increase by about 1.2
percent, assuming current price levels
and operation at 100 percent capacity.
Total annualized costs would be
increased by about $369,000 to $600,000
per year for the model plant meeting a
standard based on Option 2, depending
on whether incineration or carbon
adsorption were used as the control
technique. If these costs were passed
forward completely, the price of maleic
anhydride would increase by about 1.7
percent, assuming current price levels
and operation at ICO percent capacity.
In terms of national impact. Option 1
would require five plants to install
controls. Total nationwide capital costs
would be about $8.8 million. Option 2
would require at least seven plants to
install control systems. Total
nationwide capita! costs under Option 2
would be about ®8.t million.
The increase in the industry's total
annualized cost, assuming continued
operation at 56 percent of capacity,
would be about $2.2 million per year
under Option 1 and about S3.E million
per year under Option 2. Assuming
operation at SCO percent! cf capacity,
total annualized industry cost would be
increased by about $2.5 million per year
under Option 1 and about $d.S million
12.
The impact of a benzene standard on
the price of maleic anhydride would
depend 021 at least two factors: (1) the
percentage of capacity at which the
industry is operating, and (2) the
variation among companies with regard
to pries fees-eases needed to fully pess
through control costs.
fe W?^ the industry was operating at
53 percent of capacity, and supply was
substantially greater than demand, it io
expected that demand will equal present
listed capacity by the end of 1832 or
oooner. The increased demand could
reduce the competitiveness within the
industry Bad allow maleic anhydride
prices to iswseass to pay for control
costs. Becawfis controls to meet the
ctandard wjyald not have to be in
operation fesfcs at least January of
S88J1, the potential price increases
presented here are based on ICO percent
utilization of listed capacity.
The price increase needed to fully
pass through control costs varies from
plant to plant. The estimated price
increases presented here for Options 3
end are averages of the price increases
that would be necessary for all the
companies to fully recover their costs.
This means that these estimated price
increases would allow some companies
to fully recover their control costs but
would require other companies to
absorb some of the costs. Companies
that do not use benzene to make maleic
anhydride or that already have control
systems that would meet an option
would incur no control costs and would
not need a price increase. When the
price increases for maleic anhydride.
were estimated, consideration wao
given to these plants with little m no
control cost by averaging the pric®
increases they would need to recover
costs in with the price increases needed
by the other companies.
Eased on tae assumptions discussed
above, maleic anhydride prices would
be expected to increase from a list price
of 88^/kg (4C$/lb) by shout 1U percent if
the standard were based on Option H
and by about 1.7 percent if the standard
were based on Option 2. There are two
reasons for She differences in these
estimated price increases. First, the cost
of a control device to meet Option 2 io
greater than for a control device
controls to meet a standard based oa
regardless of the level of control
selected ao the basis for the standard.
Based on conversations with
representatives from another company
and on independent evaluation by EPA,
a second plant could close because of
control costs if the standard is based on
B9 percent control. Because this plant
already has an incinerator that can
attain 87 percent control, it would not
ceace to manufacture maleic anhydride
if the otandard is based on that control
Maleic anhydride is used Jn'the •
manufacture of polyester resins, fumarie
acid, and maJathion. Any price increaoa
in maleic anhydride is expected to fes
reflected in the price of these goods.
Based oa am evaluation by SPA, OTQ
fhis company expressed concern that,
for a combination of reasons, it could
not finance the control system that it
would need at the SB-percent control
level. One reason is that it could not
pass through all the coaio of control. The
fact that the industry is expected to be
operating at less than listed capacity
when the company would need to begin
making expenditures for control
equipment would make'it difficult to
increase the price of maleic anhydride
to compensate for those control costs.
Furthermore, because this company has
not been identified as a price leader, it
may have to absorb some of the control
costs even after the industry begins to
operate closer to listed capacity. Also,
the company io located in Texas and has
to compete with imports of maleic
anhydride from Mexico. A second
reason the company probably cannot
afford the controls is that within the last
4 years it has made a major capital
outlay for the control device that meets
the 557-percent control level, and it is still
recovering from thia investment.
Furthermore, this company only makes
two products, and maleic anhydride
represents one-third of its sales. For
other companies, maleic anhydride sales
generally represent less than 1 percent
£>f total sales. The product mix factor
limits the ability of this company to use
the profits from other operations to
finance controls for the maleic
anhydride plant.
This plant was originally designed to
use 2-butene rather than benzene as the
feedstock and has recently obtained a
State permit to use n-butane. At least
initially this company is planning to
convert part of its capacity to n-butane
on an experimental basis; it is uncertain
whether it will convert to n-butane on a
permanent basis. The company
converted one reactor to n-butane on as
experimental basis in 1375 and 1873 but
converted back to benzene due to
technical problems with the proceso asri
catalyst instability. If the plant did
convert to m-butame on a permanent
basis, it would not be affected by a
mot dose. If fee pl&nt ee>u!dl susS
V-H-8
-------
..£S, Ko. 77 I [Friday, April IS, 1@£0 / Proposed
oucceosfully convert to a-butane and the
otandard were based on £3 percent
control, the plant might have to close.
If both of these maleie anhydride
plants closed, approximately 50
employees could lose their jobs. If the
plant projected to close at either control
level were ths only plant to close, about
SO employees could loce their jobs.
Because these employees would be
. petrochemical workers and both plants
Q?3 located in areas with numerous
other petrochemical plants (Texas and
New Jersey), it io poocible they could
find employment in the same areas.
Also, one of the companies is very large
and may be able to ralocate the
omployees from the maleie anhydride
plant within the company.
In summary, it is estimated that a
standard based on BS percent control
would result in total capita! costs of
about $3.3 million, an increase in total
amiualized costs of about 84.5 million, a
potential price increase hi maleie
anhydride of 1.7 percent, cm increase im
energy usage of ©5,000 barrels (bbll
(525,000 GJ/yr OF 497J8 X 10 ° Btu/yr of
oil per year, and as many as two
projected plant closures. A otandard
based on 87 percent control would result
in total capital costs of about §8.8
million, an increase in total annualized
costs of about §2.5 million, a potential
price increase in maleie anhydride of 1.2
percent, an increase in energy usage of
about 50,000 bbl (310,000 GJ/yr or 293.8
X 10 ° Btu/yr) of oil per year, and as
many as one projected plant closure.
In selecting best available technology
(considering environmental, energy, and
economic impacts) (BAT), the
Administrator examined the impacts
discussed and arrived at the following
conclusions. First, control in the range of
97 percent is the best demonstrated
control that has been achieved at an
existing maleie anhydride plant with a
control system that is applicable to all
other existing plants. Higher levels, such
as 99 percent, are believed to be
technically feasible, but only with
technology transfer and at a higher cost
and energy use. Second, one plant that
is not projected to close if the standard
were based on 97 percent control is
projected to close at the 89-percent
control level if it cannot successfully
convert to n-butane. Based on these two
considerations, the Administrator
selected the 97-percent control option as
BAT.
After the 97-percent option was
identified as BAT for existing sources,
the estimated risks remaining after
application of BAT were examined to
determine whether they are
unreasonable in view of the health
benefits and costs that would result if a
more otriragant option were applied. The
slumber of estimated leukemia deaths
.rameMag after application of BAT to
existing oourcso io estimated to range
feera 0.03 to 0.19 par year.0 Fifty percent
of these residual deaths would result
from fagitiws, cseondary, and storage
and fondling emissions, which will be
©onoiderad for regulation at a later date.
After application of BAT to existing
oourcoo, <&e remaining estimated
maximum lifetime risk of acquiring
tsukemia io eottoatsd to range from 5.8
X 2fl~° to
-------
:®f / Vol. 45, No. 77 I Friday. April 18, 1080 / Proposed Rules
exposure to n-butane by workers is less
hazardous than exposure to benzene, n-
Butane is already used as a feedstock
for similar situations within the
petrochemical industry.
There are two potentially adverse
environmental impacts of requiring the
use of n-butane in place of benzene as
the feedstock for new sources. These
include possible increased benzene
emissions from gasoline marketing and
increased volatile organic compound
emissions. If eliminating benzene as a
feedstock for new sources resulted in
the addition of more benzene to
gasoline, the incremental increase in
total'benzene emissions from gasoline
marketing would be greater than if the
benzene were used at a controlled
maleic anhydride plant.
Because existing sources can continue
to use benzene as a feedstock, only the
benzene that would have been used at
new sources would be of concern.
Currently, benzene demand often
exceeds the available supply; this
situation is expected to continue through
the 1980's. Consequently, the benzene
that would be used at new sources, if
there were no standard, is not currently
being produced, and if new maleic
anhydride plants wanted to use benzene
as their feedstock, an increase in
benzene demand would result.
Typically, when demand for benzene
fluctuates, supply is adjusted by
changing the level of production from
the most expensive source. If benzene
were not prohibited as a feedstock for
new sources and there was little, if any,
slack in the benzene supply, the
additional benzene required would
probably be supplied by toluene
hydrodealkylation (HDA). HDA is the
most expensive benzene production
method and changes in benzene demand
can be accommodated by changing the
volume of benzene production from
HDA. HDA production currently
represents 25 to 30 percent of benzene
production. Since existing maleic
anhydride plants currently use 3 percent
of the benzene produced, the HDA
process should be able to accommodate
fluctuations in demand for benzene
caused by maleic anhydride producers.
If chemical process industries know
that benzene will not be used as a
feedstock for maleic anhydride
production, they will presumably adjust
their projections of future benzene
demand. Additional benzene production
capacity would be adjusted to reflect
this decrease in demand for benzene as
a feedstock for new maleic anhydride
sources.
Thus, based on these considerations,
it was concluded that the proposed
standard would be unlikely to result in
more benzene being added to the
gasoline pool.
Although few data ere available on
:be qu••• itity and composition of the
emissions of volatile organic compounds
(VOC) from an n-butane-based plant,
preliminary information indicates that
total uncontrolled VOC emissions are
higher than for a benzene-based plant.
At present, there is no nationwide
requirement to control the emissions
from the n-butane oxidation process for
maleic anhydride production. However,
VOC emissions are currently controlled
by State regulations where new n-
butane-based plants are likely to be
constructed. In addition, EPA is
beginning work on a new source.
performance standard under Section 111
of the Clean Air Act for all air oxidation
reactions in the organic chemical
industry. This standard is anticipated to
cover maleic anhydride production from
n-butane.
The potential economic impacts of
requiring n-butane include impacts on:
(1) domestic licensors of n-butane and
benzene technology, (2) availability and
price of n-butane and benzene
feedstocks, and (3) the economic life of
existing maleic anhydride plants.
Only one domestic licensor of maleic
anhydride technology exists. This
licensor licenses both the benzene and
n-butane processes. Abroad, there are
five licensing companies. Of those five,
only one licenses both benzene- and n-
butane-based technology, while the
other four solely license the benzene-
based process. The U.S. licensor would
probably maintain its foreign business
because an EPA requirement would not
affect usage of benzene-based
technology abroad. However, the
company'o domestic business would
depend on the competitive status of its
n-butane catalysts at the time that
benzene replacement is mandated.
Because catalyst technology is usually &
closely held company secret, the
companies developing such catalysts
and their rates of success with new
catalysts have not been determined.
Use of n-butane as a feedstock can
lead to as much as a 7.3$ cost reduction
per kilogram over benzene feedstock
costs. This difference in feedstock costo
is not expected to lessen in the next 10
years and may even increase. Supplies
of n-butane are expected to exceed
demand through 1S2D, while benzene
demand will probably continue to
exceed supply.
Requiring the use of n-butane for new
sources would not affect the economic
life of existing plants. Because of the
cost advantage associated with using
the n-butane feedstock, maleic
anhydride manufacturers are likely to
decide to use the n-butane process for
new sources regardless of an EPA
mandate to do so. For example, the only
new maleic anhydride plant announced
in recent years will be a 45,4CO-Mg/yr
(50,000 tons/yr) plant based on
proprietary n-butane technology.
Construction is expected to be
completed in 1983. Consequently, any
impacts that occur on the economic life
of existing plants from new plants using
n-butane cannot be directly attributed to
(the EPA mandate.
In summary, the potential safety,
environmental, and economic impacts
associated with requiring new sources
to use an alternative feedstock such as
n-butane are minimal. Consequently, 100
percent control has been selected as
EAT for new sources. Because this level
of control is expected to result in no
benzene emissions, it is not necessary to
consider & level of control beyond BAT
for new sources.
Because experience indicates that
control systems are not 100 percent
reliable, control system malfunctions
and associated emissions in excess of
the numerical emission limit for existing
sources can be expected to occur at
maleic anhydride plants. Even if a
maleic anhydride source were shut
down because of control system
malfunction, there would still be
emissions in excess of the level of the
numerical emission limit during
shutdown. For an average-sized plant
with a capacity of 22,700 Mg/yr (25,000
tons/yr} and three reactors, it is
estimated that 250 kilograms (550
pounds) of excess benzene emissions
would occur, during a controlled
shutdown, assuming the plant is
operating at the average benzene
conversion rate of 94.5 percent.
Although the benzene feed to a reactor
could be stopped immediately, the
benzene in the system would have to be
purged to the atmosphere, which
generally takes 15 to 20 minutes.
Furthermore, if a plant had more than
one reactor, the reactors would probably
have to be shut down sequentially to
avoid damaging the equipment. Most
control system malfunctions at maleic
anhydride plants can be repaired
relatively quickly, within 12 hours at a
maximum. Occasionally, a control
system malfunction requiring extensive
repair time can occur.
The Administrator considered four
different regulatory options for the
treatment of emissions in excess of the
level of the numerical emission limit due
to control system malfunctions at maleic
anhydride plants: (1) allowing unlimited
excess emissions. (2) requiring plants to
V-H-10
-------
Foderal Register / Vol. 45, No. 77 / Friday, April 18. 1980 / Proposed Rules
shut down during control system
malfunctions or to have no more
emissions than if they did shut down. (3]
requiring installation of a flare, and (4)
allowing no excess emissions (i.e.,
essentially requiring installation of a
backup control system that is equally
efficient to the primary control system).
The Administrator considered options
only for treatment of excess emissions
during control equipment failures. He
did not consider allowing excess
emissions during routine startup or
shutdown or during process equipment
failures based on the judgment that the
air pollution control equipment at maleic
anhydride plants is capable of
preventing excess emissions during
these periods.
The Administrator eliminated Options
(1) and (3} based on a preliminary
analysis. Option 1, allowing unlimited
uncontrolled emissions during control
system malfunctions, could significantly
increase total mass emissions per year.
For example, one existing maleic
anhydride plant has had a control
system malfunction that took about a
year to repair. Although such events are
expected to be rare, allowing
uncontrolled emissions of benzene from
maleic anhydride plants for this period
of time was not judged appropriate. The
next most stringent option (i.e., requiring
plants to shut down or have no more
emissions than if they shut down), could
result in lost production but does not
appear to be economically prohibitive.
Therefore, the option of allowing
unlimited excess emissions during
control system malfunctions was not
analyzed further.
The option of requiring a flare during
a control system malfunction at first
appeared to be a desirable option
because flares could achieve some
emission reduction during malfunctions
of primary control systems and yet are
generally less expensive than control
systems such as incinerators and carbon
adsorbers. However, traditionally, flares
have not been used on sources, such as
maleic anhydride plants, which have
high-volume, low-concentration exiting
gas streams. The control efficiency is
not known but is expected to be
considerably less than that of an
incinerator or carbon adsorber for a
high-volume, low-concentration stream.
In addition, considerable quantities of
natural gas would be required to flare
the dilute waste gas stream found at
maleic anhydride plants. The waste gas
stream contains about 98 kcal/m3 (11
Btu per standard cubic foot [SCF]),
which is well below the levels for
efficient use of flares. Therefore, up to
19,800 ms/hr (700,000 SCF/hr) of natural
gas would be required to operate the
flare. Also, the flare would need to be
operated from 5 to 20 hours per month in
order to ensure rapid startup during
control system malfunctions and to
maintain it in efficient operating
condition. This would require additional
energy. For these reasons, the use of a
flare during control system malfunctions
did not appear to be a desirable control
option for sources such as maleic
anhydryde plants, which have high-
volume, low-concentration waste gas
streams.
Consequently, two regulatory options
were further analyzed: Option 2,.
requiring plants to shut down during
control system malfunctions or to have
no more emissions that if they did shut
down; and Option 4, allowing no excess
emissions.
In order to estimate the costs that
would result from allowing excess
emissions equal to uncontrolled
shutdown emissions, data on the
frequency and duration of control
equipment failures at two maleic
anhydride companies were obtained.
One company uses incineration and the
other uses carbon adsorption. The
company with the incinerator has
experienced about 15 relatively short-
term control equipment failures a year.
If the approach under consideration
were implemented, this company's plant
could be operated in a modified manner
with a reduced production rate during
most malfunctions and have no more
emissions than if it were shut down.
Possible costs include 15 to 42 hours of
lost production per year. It is estimated
that the net cost of lost production
would be $1,000 to $1,500 per hour for a
plant with a capacity of 22,700 Mg/yr
(50,000 tons/yr). Whether the total
annual production would actually be
reduced because of such a regulation
would depend on whether the plant was
operating at less than full capacity and
thus could compensate for the lost
production. The probability of a
malfunction requiring extended repairs
and complete shutdown because of the
proposed regulation appears small.
The company with the carbon
adsorber has found that most control
device failures affect only one of the
three beds. Such failures can be handled
by reducing feed rates and operating the
remaining two beds normally while the
affected bed is isolated and repaired.
Complete control device failure usually
takes only 1 to 4 hours to repair.
Therefore, the only possible result of the
option of allowing excess emissions
equal to shutdown emissions for a plant
with carbon adsorption is again possible
reduced production.
Because of several factors, the total
industry cost of lost production that may
result if this option were implemented is
difficult to quantify without doing a
detailed plant-by-plant analysis.
Ordinarily, plants do not operate at full
capacity for extended periods of time
due to market, maintenance, or other
conditions. Consequently, the
production foregone during the time
required to repair the control system
can, in many cases, be made up by
increasing production rates after the
repair is completed. The extent to which
this can be done is expected to vary
from plant to plant and from time to
time within a plant. Other factors, such
as the type of control system used, the
design of the plant, the number of
reactors within a plant, the use of the
steam produced during maleic
anhydride production, and the nature
and extent of the control system
malfunctions are expected to vary from
plant to plant and will affect the
magnitude of production revenue
actually foregone for the entire industry.
However, if the option of allowing
excess emissions equal to those of
shutdown were adopted, the ensuing
costs are anticipated to result in no
additional plant closures. Also, because
only production curtailment would be
involved, energy impacts and negative
environmental impacts would not
increase in relation to normal operation.
For the option of allowing no excess
emissions during control system
malfunctions (i.e., essentially requiring
backup control systems), the model
plant would incur additional capital
costs of about $800,000 and an increase
in annualized costs of about $223,000
above those costs without backup. The
total capital costs for the industry (for
both a primary and backup control
system) would be about $13.9 million.
the total annualized costs would be
about $4.4 million, and the maleic
anhydride price would increase about
2.0 percent. Furthermore, the same plant,
which already has a 97-percent efficient
incinerator and which is projected to
close if the standard were based on 99
percent control, is also projected to
close if it were required to install a
backup control system.
In selecting BAT, the Administrator
first examined the option of allowing no
excess emissions. This option would
more than double the industrywide
capital costs. The Administrator
rejected this option as BAT because he
considered the increase in capital costs
grossly disproportionate to the emission
reduction achieved and because the
plant closure projected to occur if he
selected it could be eliminated by
V-H-11
-------
Federal Register / Vol. 45, No. 77 / Friday. April 18, 1980 / Proposed Rules
selecting the option of allowing excess
emissions equal to those that would
occur during shutdown. Because the
impacts and costs of the option of not
allowing excess emissions to exceed
those that would occur during shutdown
appear reasonable, he selected that
option as BAT. This approach for
selecting BAT for controlling excess
emissions is similar to the approach
used in determining BAT for continuous
emissions. That is, it is based on the
technologies and associated economic
and environmental impacts specific to
the source being regulated. Because the
available technologies and associated
impacts for controlling excess emissions
from other sources regulated under
Section 112 are likely to differ, it should
not be assumed that BAT for controlling
excess emissions from maleic anhydride
plants will necessarily be applied to
other sources.
In order to calculate the risks
remaining after application of BAT to
existing sources (i.e., a combination of
97 percent control during normal
operation and allowing excess
emissions during control system
malfunctions equal to those during
shutdown), the expected frequency of
malfunctions was assumed to be 15 per
year and the total quantity of
uncontrolled emissions that would occur
during shutdown was assumed to be 250
kilograms (550 pounds]. A frequency of
15 malfunctions per year was selected
for this analysis based on the data
supplied by the plant with an
incinerator. It is considered to be "worst
case" because some of the control
system breakdowns experienced by this
company may have been avoidable and
therefore would not be expected to
occur if the proposed standard were in
effect. Exposure estimates were
obtained for the shutdown period and
normal operation. The linear dose-
response model was then used to
calculate residual leukemia cases using
both types of exposure.
The Administrator considered the
possibility that when these short-term
peak exposures, which may range up to
2.0 ppm for up to 3 hours duration, are
mixed with chronic, relatively low
exposures, the linear model may not
provide conservative estimates of
incidence and risk. This question arose
because a recent study funded by the
Consumer Product Safety Commission
indicated that one exposure to a high
level of vinyl chloride (another
carcinogen regulated under Section 112}
can result in a higher probability of
cancer risk than the same dosage spread
over a longer period of time. The
exposure levels used in the vinly
chloride study were much higher than
benzene exposures that would occur
around maleic anhydride plants during
control system malfunctions. In
add.lion, analysis of previous
occupational benzene exposure
studies—upon which calculations in the
EPA Carcinogen Assessment Croup's
Report on Population Risk to Ambient
Benzene Exposures are based—shows
that, for benzene concentrations with a
range of 0.2 ppm to 4.0 ppm, the lifetime
probability of cancer is approximately
proportional to the concentration.
Consequently, the linear model is valid
for the range of ambient benzene levels
anticipated to occur during control
system malfunctions, and there is no
reason to expect that peak exposures of
up to 2 ppm would have a higher level of
cancer incidence per part-per-million
year of exposure than lower continuous
exposures. For these reasons, the
Administrator has judged that the linear
model can be expected to provide
conservative estimates of incidence and
risk at the exposure levels that would
occur during control system
malfunctions at maleic anhydride
plants. For different pollutants or
sources with different emission
characteristics, this relationship may not
hold, and short-term peak exposures
may indeed cause a higher level of
cancer than indicated by the linear
model.
The number of leukemia deaths
remaining after application of BAT
(including the allowance for emissions
in excess of the level of the numerical
emission limit) to existing sources was
estimated to range between 0.026 to 0.18
per year within 20 km of the sources.
The maximum lifetime risk from
exposure to all sources within a plant to
the most exposed population was
estimated to be 5.8 x 10"6 to 41 x 10"5
and, from exposure to the process vents
only, it was estimated to be 0.50 x 10"5
to 3.5 x 10"5.
The Administrator next analyzed the
option of allowing no excess emissions
during control system malfunctions; i.e.,
requiring a backup control system equal
in efficiency to the primary control
system as an option beyond BAT. Thus,
there would be a reduction in the
estimated number of leukemia deaths
from a range of 0.026 to 0.18 per year to
a range of 0.025 to 0.17 per year. The
estimated maximum lifetime risk from
exposure to emissions from the process
vents and to emissions from all sources
within the plant would remain
unchanged.
Requiring a 97-percent efficient
backup control system in addition to a
87-percent efficient primary control
system would increase the capital costs
from $6.5 million to $13.0 million, the
total annualized cost from $2.5 million to
$4.4 million, and the percentage increase
in maleic anhydride prices from 1.2 to
2.0. It would also increase the number of
potential plant closures from one to two.
After weighing the costs and benefits of
selecting this option, the Administrator
determined that the residual risks after
applying a standard to existing sources
based on BAT for controlling excess
emissions would not be unreasonable.
Therefore, the proposed standard is
based on this level of control.
To limit the frequency of excess
emissions due to control system
malfunctions, control system
malfunction is defined in the proposed
standard as "any sudden and
unavoidable failure of air pollution
control equipment." This places the
burden on the plant owner or operator
to prove that emissions in excess of the
numerical emission limit were
unavoidable; i.e., no emissions in excess
of the numerical emission limit would be
allowed unless the Administrator were
satisfied that an unaveidable equipment
failure had occurred. Failures caused
entirely or in part by poor maintenance.
careless operation, deficiencies in
design, or any other preventable upset
conditions or preventable equipment
breakdown would not be considered
malfunctions. Recurring patterns in air
pollution control equipment failure may
be considered indicative of preventable
failures.
Section 61.93 of the proposed standard
includes requirements for implementing
this approach. These requirements
would be implemented in the following
manner: Section 61.10 of the General
Provisions requires submittal of an
initial report from each existing source
describing the source and emissions;
Section 61.93 of the proposed standard
would require that the initial report
include information necessary for
determination of the total uncontrolled
mass emissions during a controlled
shutdown of a source. The required
information would consist of a
description of the shutdown procedure
at each plant, including a step-by-step
account, the time period required for
each step, and the amount of emissions
expected to occur during each step.
Emissions would be calculated based on
the assumption that the plant is
operating at full capacity with no
control device. Using information
gathered during development of the
standard, the Administrator would
review the information submitted by the
source owner or operator and approve
or disapprove the shutdown emissions
V-H-12
-------
/ Vol.
-------
sir / Vol. 08, No. 77 I Friday, April IB. 1880 / Proposed Rules
Also, reactors may be operated in
parallel with all emissions routed to 0
single product recovery absorber. If a
rear-tor required replacement because of
expb- ion or other damage, n-butane or
another nonbenzene feedstock would be
required for the new reactor, while the
other reactors could continue to use
benzene. But the associated product
recovery absorbs? and refining system
may still be designed for bsBssae use
only. Such a situation czrnM present
operational problems. The
Administrator has already decided not
to require existing sources to convert to
a nonbenzene feedstock. Designating
individual pieces of equipment as the
source' could have essentially the same
consequences. Therefore, foe decided
against this option.
Next, the Administrator considered
designating as the source a maleic
anhydride production unit; i.e., a
functionally integrated combination of
reactor(s), recovery absorber-fa), and
refining systems. In this case, if an
existing reactor exploded end had to be
replaced, the new reactor could use
benzene. However, as this group of
equipment aged and had to be
substantially or partially replaced, the
new grouping of equipment would have
to use a nonbenzene feedstock.
Similarly, if the capacity of a maleic
anhydride plant was increased by
adding a new grouping of this
functionally integrated equipment, that
equipment would have to use a
nonbenzene feedstock. Designating the
source in this way appeared to be most
consistent with the Administrator's
decision not to require conversion of
existing sources to a nonbenzene
feedstock because of technological and
economic uncertainties. However, when
a firm is preparing for major
construction; i.e., substantially replacing
existing equipment or increasing
capacity, it has the opportunity to
incorporate into its planning the use of a
nonbenzene feedstock. In these cases,
the Administrator considers requiring
the use of a nonbenzene feedstock
reasonable.
Therefore, the grouping of facilities
designated as the source to which the
proposed standard applies is a maleic
anhydride production unit. If
construction of a maleic anhydride
production unit were commenced after
proposal of the standard, it woidd be
considered new. If a new maleic
anhydride production unit were added
to an existing plant, it would be
considered new. If an existing maleic
'anhydride production unit were
completely replaced or if it ware
partially replaced and met (the crtterfora
fffi? being "reconotmcted," it would be
censidered new. Due to the way in
which "modification" is defined in
Section 85t.C2{j), if capacity or other
physical changes were made to an
existing sisleic anhydride production
unit, such a& tfoe addition of a reactor,
aed if fises^wsre no concomitant
increoca m benzene emissions (in mass
per unit time) from the unit, the unit
would not be considered "modified" and
would stil be considered an existing
source. Remissions did increase.
however, the unit would be considered
modified and new.
A number ef different formats could
be selected to limit benzene emissions
from existing sources. These include
concentration, standards, mass
standardo liantmg EmioeionB in terms of
benzene pa- unit of maleic anhydride
produced, and mass standards limiting
emissions in terms of benzene per unit
of benzene supplied to the reactor.
Typically, a concentration standard is
preferred over a mass standard because
a mass standard requires more
measurements and conversion
calculations. Exhaust gas flow rates and
raw material or product flow rates have
to be measured, and concentration
measurements have to be converted to
mass measurements.
The standard for maleic anhydride
plants is based on two types of control
devices—incineration and carbon
adsorption. In both cases, there is a
potential for air dilution. Excess air is
used in incinerators to ensure complete
combustion, and the quantity of excess
air used can vary. Carbon adsorption
systems use air to cool the bed during
the regeneration cycle. The cooling air
strips residual benzene remaining on the
regenerating bed and consequently must
be controlled in the bed that is in the
adsorption phase of the cycle. Again, the
quantity of cooling air used can vary
among adsorption units. Due to the
potential for air dilution, correction
factors are necessary to ensure that
measurements of emissions from all
control devices are referenced to the
same basis, and that the quantity of
benzene omitted is the same no matter
how much excess air is used in an
incinerator or how much cooling air is
used in a carbon adsorption unit
If incinerators are used, correction
factors referencing all calculations to a
specific oxygen concentration level in
the exhaust gases are a solution to the
problem of using varying quantities of
excess air. These factors, however, do
not compensate for indirect air dilution
resulting from combustion of more fuel
and all? ttian to sseeBosaiy. T5»is cihaotioa
occasionally arises where steam boilers
are pressed into service as incinerators.
Even though the exit gas concentrations
are low in these cases, the volume io so
large that emissions are occasionally
higher than if an incinerator were used.
In any event, a concentration standard
would require a measurement of exhaust
gas oxygen concentration.
If carbon adsorption were used, the
coaling air flow low rate and the total
flow rate would have to be measured,
and the cooling air flow rate subtracted
from the total flow rate. Measurement of
the cooling air flow rate to a
regenerating bed could be difficult.
Alternatively, an oxygen correction
factor could be used that references
calculations to the oxygen concentration
level of the absorber waste gas stream
as it is released from the absorber. In
this case, two measurements of oxygen
concentration level would be required:
the absorber waste gas stream and the
exhaust gaseo discharged to the
atmosphere.
In comparison, concentration, total
flow rate, and benzene feed rate or the
maleic anhydride production rate would
have to be measured to calculate mass
emissions. Maleic anhydride plants
already measure the benzene feed rate
because most plants must operate below
the benzene explosive limit. Therefore.
enforcement of a mass standard would
require no more measurements and
calculations than a concentration
standard.
Also, it is possible that some
expansion of existing plants might take
place by the addition of n-butane
oxidation reactors to an expanded
existing maleic anhydride refining
system, which also continued to refine
maleic anhydride from benzene
oxidation reactors. In this situation, the
waste gao stream from the product
recovery absorber would be a mixture of
n-butane and benzene oxidation waste
gases. As a result, enforcement of a
concentration standard, or a mass
standard limiting benzene emissions in
terms of maleic anhydride production.
would effectively give a source !
combining n-butane and benzene
oxidation a higher emission limit than a
benzene oxidation source of the same
capacity. A mass standard limiting
emissions in terms of benzene per unit
of benzene supplied to the reactor,
however, would avoid this potential
problem. Therefore, this format has been
selected to limit emissions from existing
sources, both to avoid this problem and
because this format would minimize
required measurements for enforcement.
A mass standard limiting emissions in
terms of benzene per unit of benzene
supplied to the reactor, however, is not
V-H-14
-------
to? / Vol. «5, No. 77 I Friday, April
appropriate for new maleic anhydride
production facilities. Since the basis for
the standard for new oourceo assumes n-
butane oxidation, new sources are
expected to have no benzene emissions.
However, the quantity of emissions
considered to be "zero" depends on the
measurement method. Consequently, the
format to limit emissions from new
oources is no detectable benzene
emissions as measured with Test
Method 110 specified in the proposed
otandard for benzene emissions from
As discussed above, the format
oelected for the proposed standard as
applied to existing sources was benzene
emissions per unit of benzene fed to the
reactor. Benzene emissions from a
source are a function of the efficiency of
ihe conversion of benzene Jo maleic
anhydride and other organic byproducts
in the reactor and the efficiency of the
emission control device.
• With regard to the reactor conversion
efficiency, data available in published
literature indicate that uncontrolled
benzene emissions from the product
recovery absorber and refining system
represent 3 to 10 percent of the benzene
fed to the reactor. This range in
conversion efficiency is caused by
variations in operating parameters,
including the age of the catalyst. To
include consideration of normal process
fluctuation, a conversion efficiency of 80
percent was selecte.fi Based on this
conversion efficiency, the uncontrolled
emission rate is 110 kilograms (22
pounds) of benzene emitted per 100
kilograms (220 pounds) of benzene fed
to the reactors.
As discussed earlier, a control level of
97 percent has been selected as the
basis for the proposed standard for
existing sources. The numerical
emission limit, therefore, is selected as
0.30 kilogram of benzene per ICO kg (0.30
lb/100 Ib) of benzene fed to the
reactor(s).
The proposed emission test method
for determining benzene emissions at
oources using benzene as a feedstock is
Method 110, which requires the use of a
gas chromatograph with a flame
ionization detector.
The averaging time selected for
measuring benzene emissions by Test
Method 110 at sources in maleic
anhydride plants is based on the type of
eontrol device used. If a control device
Ouch as a carbon adsorber that operates
fin cycles is used, the averaging time for
oae run io equivalent to one cycle of the
emit. Potential fluctuation in emissions
say occur over the operating cycle of a
carbon adsorber. Requiring that each
Fun include an entire control device
operating cycle ensures that these
potential fluctuations in emissions are
.Tkeasuffid. A cycle in the monitoring of a
carbon adsorption unit begins when air
containing benzene is fed to the reactor
and continues through the adsorption,
desorption, and cooling and drying
stages. For control devices such as
incinerators, large fluctuations in
emissions are not expected during
normal operation, and the averaging
time selected for each run was 1 hour.
An emission test for benzene emissions
is to consist of three contiguous runs as
described above. The arithmetic mean
of the results of three runs is to be used
to determine compliance. Equivalent or
alternative emission test methods may
be used if they are approved by the
Administrator.
Em5oa5on Monitoring
The objective of monitoring
requirements is to provide a quick and
easy means for enforcement personnel
to ensure that an emission qontrol
system installed to comply with the
standard is properly operated and
maintained. For sources in maleic
anhydride plants, the most
straightforward means of ensuring
proper operation and maintenance
would be to monitor emissions released
to the atmosphere. Preliminary
indications are that a continuous
emission monitoring system employing
gas chromatography to measure benzene
emissions would cost about $35,000.
Since this cost is considered reasonable,
the proposed standard includes
monitoring requirements for plants using
benzene as the feedstock.
Gas chromatography with a flame
ionization detector, or an equivalent
benzene monitoring system, is. required.
This system has to be operational prior.
to conducting the emission tests
required under Section 61.03 so the
continuous monitoring system can be
evaluated.
The standard requires that the
composition of reference gases used for
the daily span check calibration of
monitoring equipment be certified by the
gas manufacturer. To certify
composition, the concentrations of gases
contained in each cylinder must have
been determined by direct analysis with
the analytical instrument being
calibrated on the day of analysis.
Calibration (Section 5.2.3.2 of Test
Method 110) of the analytical procedure
is performed using gases that have had
their concentrations verified: (1) by
accordance with the procedure
described in Section 7.1 of Test Method
110 and using 68 mole percent benzene,
or (2) by direct analysis by the National
Bureau of Standards.
The averaging time selected for
determining the level of emissions with
ihe continuous monitor is equivalent to
the averaging time of an emission test;
that is, three operating cycles for carbon
adsorption systems, or 3 hours for other
control systems.
Upon written application, the
Administrator may approve alternative
monitoring procedures or systems for
specified conditions. For example, it is
possible that a plant would be allowed
to report benzene emissions in parts per
million, instead of kilograms of benzene
emitted per kilograms of benzene fed to
the reactor, if it could demonstrate that
it is meeting the standard using this
method.
A public hearing will be held to
discuss the listing of benzene as a
hazardous air pollutant under Section
112 and the proposed standard for
maleic anhydride in accordance with
Sections 112(b)(l)(3) and 307(d)(5) of the
Clean Air Act. Person wishing to make
oral presentations on the listing of
benzene or the proposed standard for
maleic anhydride plants should contact
EPA at the address given in the
Addresses section of this preamble. Oral
presentations will be limited to 15
minutes each. Anymember of the public
may file a written statement before,
during, or within 30 days after the
hearing. Written statements should be
addressed to the Central Dock'et Section
address given in the Addresses section
of this preamble and should refer to
docket number OAQPS 78-3.
A verbatim transcript of the hearing
and written statements will be available
for public inspection and copying during
normal working hours at EPA's Central
Docket Section in Washington, D.C. (see
Addresses section of this preamble).
EDodket
The docket is an organized and
complete file of all the information
submitted to or otherwise considered by
EPA in the development of this proposed
pulemaking. The principal purposes of
the docket are (1) to allow members of
the public and industries involved to
identify and locate documents so they
can intelligently and effectively
participate in the rulemaking process,
and (2) to serve as the record in cms of
Judicial review.
V-H-15
-------
Federal Register / Vol. 45, No. 77 / Friday. AprH 18. 1980 / Proposed Rules
Miscellaneous
As prescribed by Section 112. the
proposal of this standard was preceded
by the Administrator's determination
that benzene is a hazardous air
pollutant as defined in Section I12(a)(l)
of the Act. Benzene was added to the
list of hazardous air pollutants on June
8,1877. The Administrator, however,
wfll consider information alleged to
show that benzene does not cause or
contribute to air pollution that may
reasonably be anticipated to result in an
increase in mortality or an. increase in
serious, irreversible, or incapacitating,
reversible illness.
In accordance with Section 117 of the
Act, publication of this proposal was
preceded by consultation with
appropriate advisory committees,
independent experts, and Federal
departments and agencies. The
Administrator will welcome comments
on all aspects of the proposed
regulations, including health, economic,
and technological issues, and on the
proposed test method. Even though 97
percent control is the basis for the
proposed standard, the Administrator
has reserved the option of considering
promulgation of a standard based on 99
percent control. For this reason,
comments on the technological and
economic aspects of requiring 99 percent
control are specifically invited.
Recent information indicates that two
benzene-based plants are considering
conversion to an n-butane feedstock. In
addition, one State has recently
promulgated generic standards for toxic
pollutants that may require more control
of benzene than is currently assumed in
the emission reduction estimates
projected for this regulation. EPA will
monitor these potential changes during
the proposal period and evaluate their
impact on emissions.
The Administrator welcomes
comments on the appropriateness of the
proposed regulation in light of these
factors and invites suggestions and
comments on alternatives to the
NESHAP regulation to control benzene
emissions from maleic anhydride plants.
The Agency invites discussion of any
alternative approaches that may achieve
comparable health protection with less
burden to EPA and to industry than
Section 112 regulation. Specifically, the
Agency requests comment on the
feasibility and desirability of voluntarily
developed compliance agreements,
negotiated between a source and EPA or
the State, as a means of assuring
adequate control of these facilities.
Under EPA'o sunset policy for
reporting requirements in regulations,
the reporting requirements in this
regulation will automatically expire 5
yearn from the date of promulgation
unless affirmative action is token to
extend them. To accomplish this, a
provision automatically terminating the
reporting requirements at that time will
be included in the text of die final
regulations.
This regulation will be reviewed 5
years from the date of promulgation.
This review will include an assessment
of such factors as new information on
health effects, die need for integration
with other programs, die existence of
alternative methods, enforceability, and
improvements in emission control
technology.
Dated: April 4, M30.
Doeglae M. Costta,
Administrator.
It is proposed that Part 61 of Chapter
I, Title 40 of die Code of Federal
Regulations be amended by adding a
new Subpart H, a new Test Method 110
to Appendix B, and a new Appendix C
containing Supplements A and B to
Method 110, as follows:
Subpart H—NaWonci Emission Standard for
Benzena Emissions from Ctetete Anhydride
Plants
Sec.
61.90 Applicability and designation of
source.
61.91 Definitions.
61.92 Emission'standard and compliance
provisions.
61.93 Excess emissions.
61.94 Emission test and procedures.
61.95 Emission monitoring.
61.96 Recordkeeping requirements.
Authority: Sec. 112,114, and 301(a), Clean
Air Act as amended [42 U.S.C. 7412, 7414. and
7601(a)], and additional authority as noted
below.
Subpart H—National Emission
Standard for Benzene Emissions from
Maleic Anhydride Plants
§61.90 Ap4»tcoWUty end designation of
source.
(a) The provisions of this subpart are
applicable to die following source: any
maleic anhydride production unit that
produces a total of 500 Mg or more per
year of maleic anhydride, maleic acid,
or both, either as an end product or as
an intermediate product.
{61.91 DaflnTOono.
Terms used in diis subpart are defined
in die Act, in Subpart A of diis part, or
in diis section as follows:
(a) "Continuous monitoring system"
means die total equipment used to
sample, to analyze, and to provide a
permanent record of emissions or
proosso pcronratOTO.
(b) "Control system malfunction"
means any sudden and unavoidable
failure of air pollution control
equipment. A failure caused entirely or
in part by deficiencies in design, poor
maintenance, careless operation, or
other preventable upset condition or
preventable equipment breakdown is
not considered a malfunction.
(c) "Controlled shutdown" means die
termination of benzene feed to die
reacror(s) in a manner that results in die
least amount of benzene emissions
without damage to air pollution control
or process equipment
(d) "Maleic anhydride production
unit" means any functionally integrated
combination of reactors, product
recovery absorbers, and refining
systems used to produce maleic
anhydride or maleic acid.
(e) "Product recovery absorber"
means any equipment in which a gas
stream containing maleic anhydride or
maleic acid is contacted with an
absorbent liquid to recover die maleic
anhydride, maleic acid, or both as a
mixture.
(f) "Reactor" means any vessel in
which benzene or an other feedstock is
partially or totally oxidized to maleic
anhydride or maleic acid.
(g) "Refining system" means
equipment used to separate maleic
anhydride or maleic acid from other
material or liquid and to dehydrate
maleic acid to maleic anhydride. It also
includes pieces of equipment used to
keep refining columns, evaporators,
crystallizers, and other unit separation
process equipment under negative
pressure.
(h) "Run" means die net period of time
during which an emission sample is
collected.
(i) "Reconstruction" means die
replacement of components of an
existing source to such an extent that:
(1) The fixed capital cost of die new
components exceeds 50 percent of die
fixed capital cost that would be required
to construct a comparable, entirely new
source; and
(2) It is feasible, considering economic
impacts and die technological problems
associated with retrofit, to meet die
applicable standard for new sources set
forth in diis subpart.
(j) "Fixed capital cost" means die
capital needed to provide all die
depreciable components.
{61.92 Emission otcnderd end
compttanco provisions.
(a) No owner or operator of a source
to which diis subpart applies shall cause
benzene to be emitted into die
atmosphere from the source m excess of
V-H-16
-------
. m. Ho. y? / i^May, Apdi 1®, HOT / Propoosd Etaleo
the appropriate emiosSca ta#! DO oteted
below:
(1) Existing oewce — ®£§> fcs/t3 ^3 of
benssne fed to the raeietoffc)), averaged
oves- fisree cycles for cai&on adoorbsro
or ever 3 hours for other ojhtrol
s. Thio emission MmK dies not
Eaoi&nsciien if tho AdEaiH8c2sn£E°F fccio
appr®ssd.B controlled shutdown saaos
eraissiom limit nndka" Q 61.93.
(2) New euurce — no detectable
fosnzene szaiosiosso QQ EaeaonEsd with
Tes4 Method 110.
(b) For the duration of a control
system malfunction, no owner or
operator of a source to which this
subpart applies shall caess fes total
mass of benzene to be emaitod from the
source in excess of the comSroUed
shutdown mass emission limit,
established under g 81.93(a), applicable
to the source.
(c) The owner or operator of each
source shall maintain and operate the
source including associated air pollution
control equipment in a manner
consistent with good air pollution
control practice for minimizing benzene
emissions. Determination of whether
acceptable operating and maintenance
procedures are being used will be based
on information available to the
Administrator, which may include but is
not limited to monitoring results, review
of operating and maintenance
procedures, and inspection of the
source.
(d) Upon reconstruction, an existing
source shall become a new source for
purposes of this subpart.
§ @H.H3 Sneooo cwteoiono.
(a) Controlled shutdown mass
emission limit. (1) The owner or
operator of each source subject to the
emission limitations in g 81.92(a)(l) and
who uses benzene as a feedstock shall
include in the initial source report
required under § 61.10, a calculation of
She total uncontrolled mass benzene
emissions that would occur from each
source for which an emission limitation
is prescribed under g 31.92(a)(l) during a
controlled shutdown. The following
information is also to be included:
(i) A complete step-by-step
description of the controlled shutdown
procedure for each process for which aa
emission limitation is prescribed under
0 0a.92(a)(l), including em account that
details each otep in the procedure.
p) The length of time it takes for each
otep of the controlled shutdown, from
teftiation to completion.
(iii) The amount of benssne emissions
computed to occur in the absence of air
pollution control equipment during each
•otep of the controlled ohutdown booed
on psadactioa rates for t&e proceon
Funning at Ml eapaciSy.
{S) The Administrator shall, wiiMn 60
days of receipt of the information
specified in paragiph (a)(l) of this
flection, notify the plant owner or
operator whether ha approves or
disapproves, ao the eummcal emission
limit applicable during Q control oystem
malfunction, the benzene emissions
computed to occur during Q controlled
shutdown in accordance with paragraph
(a)(l) of this section. In making this
determination, the Administrator shall
consider the information submitted
under paragraph (a)(l) of this section.
The Administrator may also consider
any other information available to him
jor that he may reasonably require, in
addition to sound engineering practices.
(b) Excess emissions reporting. (1) For
each occurrence of benzene emissions in
excess of the numerical emission limit,
specified in g 81.92(a){i), the owfier or
operator of that plant shall report the
occurrence to the Administrator within
10 days after the occurrence. Emissions '
in excess of the numerical emission limit
are those indicated by measurements by
an emission test or by a continuous
monitoring system over the following
period of time.
(i) When a control device is used that
operates in cycles, such as a carbon
adsorber, all periods equivalent to three
contiguous cycles of the control device
during which the average emissions
exceed the appropriate numerical
emissions limit in g 61.92(a)(l). The
emissions measured for any one cycle
are to be osed in calculating an average
only once; running averages are not
required.
(ii) When any other control device is
used, all 3-hour periods during which the
average emissions exceed the
appropriate numerical emission limit in
g 81.92(a)(l). The emissions measured
for any one cycle are to be used in
calculating aa overage only once;
running averages are not required.
(2) The owner or operator c&all submit
the following information as a minimiirn
in the report required by paragraph
(b)(l) of this section:
(i) The identity of the stack and other
emission potato where the excess
emissions occurred.
(ii) Tins identity of the equipment
causing the excess emissions.
(iii) The owner or operator shall also
state whether ©r mot he believes Q
control oystea malfunction has
occurred.
(3) If the owner or operator states that
& control system malfunction has
occurred, the following information as a
minimum te also to be included in this
repast required imdsr para^-apfa (b)(l) of
this section:
(i) The total memo of beasene
emiookmo that occurred during the
control oyotem malfunction.
(ii) The nature and cause of the excess
emissions.
(iii) The otepo taken to remedy the
malfunction and the steps taken or
planned to prevent the recurrence of
such malfunctions.
(iv) Documentation that the air
pollution control equipment, process
equipment, or processes were at all
times maintained and operated, to the
maximum extent practicable, in a
manner consistent with good practice
for minimizing emissions, and were
designed in accordance with good
engineering practices.
(v) Continuous monitoring data,
operating data, and calculations used in
determining the magnitude of excess
emissions, including but not limited to—
(A) The time and duration of the
control system malfunction;
(B) The benzene feed rate to the
reactors at the beginning of and during
the control system malfunction;
(C) The benzene conversion rate in
the reactor at the beginning of and
duriog the control system malfunction;
(D) The production rate at the
beginning of and during the control
system malfunction; and
(E) The uncontrolled benzene
emission rate during the control system
malfunction ira kilograms per 100
kilograms of benzene to the reactor.
(4) The Administrator shall determine
whether a contol system malfunction
has occurred based on the data.
submitted under paragraphs (b) (2) and
(3) of this section. In making'this
determination, the Administrator may
also consider any other information
available to him or that he may
reasonably require, in addition to sound
engineering practices. If the
Administrator determines that a control
system malfunction has occurred, he
shall determine whether the emissions
in excess of the emission limits
established in accordance with
paragraph (a) of this section have been
exceeded. The Administrator shall
notify the owner or operator of this
determination in case of violation within
60 days after receipt of the report
required under paragraph (b) of this
section.
(a) Unless Q waiver of emission
testing is obtained under g 61.13, the
owner or operator subject to the
provisions of this subpart shall test
emissions from all existing OOUTCGO in
V-H-17
-------
Foderai Register' / Vol. 45. Mo. 77 / Friday, April 18, 1880 / Proposed Rules
which benzene is used as a feedstock
within SO days of the effective date.
(b) The owner or operator of each
source shall provide the Administrator
30 days prior notice of the emissions lest
to afford the Administrator the-
opportunity to have an observer present.
(c) Any emission test is to be
conducted while the equipment being
tested is operating at the maximum
production rate at which the equipment
will be operated.
(d) Where possible, each sample is to
be analyzed within 24 hours, but in no
case later than 72 hours of sample
collection. Emissions are to be
determined within 30 days after the
emisson test. The owner or operator
shall report the determinations to the
Administrator by a registered letter
dispatched before the close of the next
business day following the
determination.
(e) The owner or operator shall retain
at the plant and make available, upon
request, for inspection by the
Administrator, for a minimum of 2 years,
records of emission test results and
other data needed to determine
emissions.
(f) The owner or operator shall use the
following test methods to determine
benzene emissions from any source for
which an emissions limit is prescribed in
§ 61.92, unlesss an alternative or
equivalent method has been approved
by the Administrator. If the
Administrator finds reasonable grounds
to dispute the results obtained by an
equivalent or alternative method, he
may require the use of a reference
method. If the results of the reference
and equivalent of alternative methods
do not agree, the results obtained by the'
reference method prevail, and
Administrator may notify the owner or
operator that approval of the method
previously considered to be equivalent
or alternative is withdrawn.
(1) Test Method 1 of Appendix A to
Part 60 is to be used to determine
sample and velocity traverses.
(2) Test Method 2 of Appendix A to
Part 60 is to be used to determine
velocity and volumetric flow rate.
(3) Test Method 110 of Appendix B to
this part is to be used to determine
benzene emissions from any source for
which an emission limit is prescribed in
§ 61.92.
(g) Each emission test is to consist of
three runs. One sample containing a
minimum volume of 50 liters corrected
to standard conditions, is to be collected
for each run. For the purpose of
determining emissions, the average of
the results from all three runs is to
apply. The average is to be computed on
a time-weighted basis.
(h) Where a control device is used
that operates in cycles, the sampling
time for each run is the time period of
one complete cycle. Where any other
control device is used, sampling time is
io be taken over a minimum of 1 hour.
(i) The sampling site is to be at least
two stack or duct diameters
downstream and one-half diameter
upstream from any flow disturbance
such as a bend, expansion, contraction,
or visible flame. The sampling point in
the duct is to be at the centre id of the
cross section. The sample is to be
extracted at a rate proportional to the
gas velocity at the sampling point. For a
rectangular cross section an equivalent
diameter is to be determined from the
following equation:
equivalent diameter = 2 (length)Width)
length + width
(j) The reactor feed rate is to be
determined during each testing period
by a method approved by the
Administrator.
(k) The mass emissions in kilograms
of benzene per 100 kilograms of benzene
fed to the reactor are to be computed by
using the following equation:
(CB (3.24) Q x lo"6)[100]
where
EB is kg of benzene/100 kg of benzene fed to
the reactor.
CB is the concentration of benzene as
measured by Test Method 110 (ppmv).
3.24 is the vapor density of benzene at 1 aim
and 20° C in kg/m3.
Q is the volumetric flow rate in m3/hr as
determined by Reference Method 2 of
Appendix A to Part 60 of this chapter.
10"°is the conversion factor for ppm.
PBU is the benzene feed rate to the reactor in
kg/hr.
(Sec. 114. Clean Air Act as amended [42
U.S.C. 7414])
(a) The owner or operator of each
source to which this subpart applies
shall install and use a continuous
monitoring system to monitor the
concentrations of benzene emissions
discharged to the atmosphere from all
existing sources that use benzene as a
feedstock. The owner or operator shall
also monitor the quantity of benzene fed
per hour to each reactor and the exhaust
gas flow rate from any device that may
discharge benzene emissions into the
atmosphere. He shall use the data
required to be collected by this
paragraph to calculate total mass
emissions of benzene in kilograms per
100 kg of benzene fed to the reactor in
accordance with the equation in
§ 61.94(k).
(b) The continuous monitoring system
to be installed in accordance with
paragraph (a) of this section is to be a
device that obtains air samples from one
or more emission points on a
continuous, sequential basis and
analyzes the samples by gas
chromatography using a flame ionizaton
detector.
(c) When the effluents from a single
source or two or more sources subject to
the same emission standards are
combined before being released to the
atmosphere, the owner or operator may
install applicable continuous monitoring
systems on each effluent or on the
combined effluent. When the sources
are not subject to the same emission
standards, separate continuous
monitoring systems shall be installed on
each effluent. When the effluent from
one source is released to the atmosphere
through more than one point, the owner
or operator shall install applicable
continuous monitoring systems on each
separate effluent unless the installation
of fewer systems is approved by the
Administrator.
(d) All continuous monitoring systems
are to be installed so that representative
measurements of emissions are obtained
and are to be operational prior to
conducting emission tests under § 61.94.
Verification of operational status is to
consist of, at the minimum, completion
of the manufacturer's written
requirements or recommendations for
checking the operation or calibration of
the device.
(e) During any emission tests required
under § 61.94 and at such other times as
may be required by the Administrator
under Section 114 of the Act, the owner
or operator of each source shall furnish
the Administrator a written report of the
measurements of benzene made by the
continuous monitoring system during the
emission test within 80 days.
V-H-18
-------
/ Vol Si, No. F7 / Friday, April 10, 1£20 / Proposed
(f) All continuous monitoring systems
used in accordance with this section ere
to complete a minimum of one cycle of
operation (sampling, analyzing, and data
recording) for each successive 15-minute
period.
(g) Owners or operators of all
continuous monitoring systems installed
in accordance with this subpart shall
check the zero and span drift at least
once daily in accordance with the
method prescribed by. the manufacturer
of such systems unless the manufacturer.
of such systems recommends
adjustments at shorter intervals, in
which case such recommendations shall
be followed. The daily span check is to
be conducted with reference gas
containing a concentration of benzene
determined to be equivalent to the
emisskm limit for that source based on
the enaassion tests required by § 61.94.
(h) fks calibration is to be done with
either—
(1) A calibration mixture prepared
from &e liquids and gases specified in
Ssction 1.2.1 and 5.2.2 of Test Method
110 and m accordance with Section 7.1
of Test Method 110; or
(2) A calibration gas cylinder
standard containing the appropriate
concentration of benzene. The gas
composition of the calibration gas
cylinder standard is to haxre been
certified by the manufacturer. The
manufacturer must have recommended a
maximum shelf life for each cylinder so
gas standards will stot be used if their
concentration has changed greater than
±5 percent from the certified value. The
data of gas cylinder preparation,
certified benzene concentration, and
recommended maximum shelf life must
have been affixed to the cylinder before
shipment from the manufacturer to the
buyer. If a gas chromatograph is used as
the continuous monitoring system, these
gas mixtures may be used directly to
prepare a chromatograph calibration
curve as described in Section 7.2 of Test
Method 110 for certification of cylinder
standards and for establishment and
verification of calibration standards.
(i) After receipt and consideration of
written application, the Administrator
may approve use of an alternative or
equivalent continuous monitoring
oyotem, alternative monitoring
procedures, or alternative monitoring
requirements.
(Sac. 114. Clean Air Act as amended [42
U.S.C. 7414])
(b) Records are to be retained at the
source and made available for
inspection by the Administrator for a
minimum of 2 years.
(Sec. 114. Clean Air Act as amended [02
U.S.C. 7414])
(a) The owner or operator of each
oource to which this subpart applies
ohall maintain daily records of the
monitoring information specified in
Performance of this method should not be
attempted by persons unfamiliar with the
operation of a gao chromatograph, nor by
those who ore unfarailar with source
campling, because knowledge beyond the
scope of thi§ presentation is required. Care
must be exerctod to prevent exposure of
campling per&naol to benzene, a
carcinogen.
S. Applicability and Prinicple
I.I Applicability. This method applies to
the measurement of benzene in stack gases
from precasoes as specified in the
regulations. The me&od doeo not remove
benzene contained EH participate matter.
1.2 Principle. An integrated bag scsnple of
stack gas containing benzene and other
organics is oubjected to gas chromatographic
(GC) analysis, using a flame ionization
detector (FID).
2. Range and Sensitivity
The range of this method is 0.1 to 70 ppm.
The upper limit may be extended by
extending the calibration range or by diluting
the sample.
3. Interferences
The chraaiatograph columns and the
corresponding operating parameters herein
described normally provide an adequate
resolution of benzene; however, resolution
interferences may be encountered on some
sources. Therefore, the chromatograph
operator shall select the column and
operating parameters best suited to his
particular analysis problem, subject to the
approval of the Administrator. Approval is
automatic provided that the tester produces
confirming data through an adequate
supplemental analytical technique, such as
analysis with a different column or GC/mass
opectroscopy, and has the data available for
review by the Administrator.
4. Apparatus
4.1 Sampling (see Figure 110-1). The
sampling train consists of the following
components:
4.1.1 Probe. Stainless steel, Pyjex * glass,
or Teflon tubing (as stack temperature
permits), equipped with a glass wool plug to
remove participate matter.
4.1.2 Sample Lines. Teflon, 6.4 mm outside
diameter, of sufficient length to connect
probe to bag. Use a new unused piece for
each series of bag samples that constitutes an
emission test and discard upon completion of
the test.
4.1.3 Quick Connects. Stainless steel,
male (2) and female (2), with ball checks (ono
pair without) located ao ohown in figure 110-
1.
0.1.4 Tedlar or aluminized Mylar bago. ICO
L capacity, to contain sample.
4.1.5 Bag Containers. Rigid leakproof
containers for sample bags with covering to
protect contents frcan sunlight.
1.1.8 Needle Veloa. To adjust sample flow
rate.
4.1.7 Pump. Leah-free with minimum of 2
L/min capacity.
4.1.8 Charcoal Tube. To prevent
admission eJ benzene and other organics to
(he Qtmoophera ia ths wsiaity of samplers.
4.1.8 How Meier. For observing sample
flow rate; capable of measuring a flow range
from 0.10 to L/min.
4.1.10 ConnectisQ Tubing. Teflon. 6.4 mm
outside diameter, to assemble sampling train
(Figure 110-1.)
4.2 Sample Recovery. Teflon tubing. 6.4
mm outside diameter, io required to connect
chromatograph sample loop for sample
recovery. Use a new unused piece for each
series of bag samples that constitutes an
emission test and discard upon conclusion of
analysis of those bags.
4.3 Analysis. The following equipment is
needed:
4.3.1 Gas Chromatograph. With FID,
potentiometric strip chart recorder and 1.0 to
2.0 mL sampling loop in automatic sample
valve. The chromatographic system shall be
capable of producing a response to O.lppm
benzene that is at least as great as the
average noise level. (Response is measured
from the average value of the base line to the
maximum of the waveform, while standard
operating conditions are in use.)
* Mention of trade names or specific products
do£o not constitute enforcement by the U.S.
Environmental Protection Afpncy.
V-H-19
-------
Federal Register / Vol. 45, No. 77 / Friday. April 18, I960 / Proposed Rules
FILTER
(GLASS WOOL)
STACK WALL
PROBE
TEFLON
SAMPLE LINE
VACUUM LINE
QUICK
CONNECTS
FEMALE
TEDLAR OR
ALUMINIZED
MYLAR BAG
NEEDLE
VALVE
FLOW METER
CHARCOAL TUBE
4
PUMP
RIGID LEAK-PROOF
CONTAINER
Figure 110-1. Integrated-bag sampling train. (Mention of trade names or specific products
does not constitute endorsement by the Environmental Protection Agency.)
V-H-20
-------
/ Vol. 45, No. 77 I Friday, April 18. 1680 / Proposed Rules
4.3.2 Chromatographic Columns. Columns
as listed below. The analyst may use other
columns provided that the precision and
accuracy of the analysis of benzene
standards ere not impaired and he has
available for review information confirming
that there is adequate resolution of the
benzene peak. (Adequate resolution is
defined as an area overlap of not more than
10 percent of the benzene peak by an
interferenl peak. Calculation of area overlap
is explained in Appendix E. Supplement A:
"Determination of Adequate
Chromatographic Peak Resolution.")
4.3.2.1 Column A: Benzene in the Presence
of Aliphatics. Stainless steel, 2.44 m by 3.2
mm, containing 10 percent 1,2,3-tris (2-
cyanoethoxy) propane (TCEPJ on 80/100
Chromosorb P AW.
4.3.2.2 Column B: Benzene With
Separation of the Isomers of Xylene.
Stainless steel, 1.83 m by 3.2 mm. containing S
percent SP 1,200/1.75 percent Bentone 34 on
100/120 Suplecoport.
4.3.3 Flow Meters (2). Rotameter type, 100
mL/min capacity.
4.3.4 Gas Regulators. For required gas
cylinders.
4.3.5 Thermometer. Accurate to 1° C, to
measure temperature of heated sample loop
at time of sample injection.
4.3.6 Barometer. Accurate to 5 mmHg, to
measure atmospheric pressure around gas
chroma tograph during sample analysis.
4.3.7 Pump. Leak-free, with minimum of
100 mL/min capacity.
4.3.8 Recorder. Strip chart type, optionally
equipped with either disc or electronic
integrator.
4.3.9 Planimeter. Optional, in place of disc
or electronic integrator, on recorder, to
measure chromatograph peak areas.
4.4 Calibration. Sections 4.4.2 through
4.4.5 are for the optional procedure in Section
7.1.
4.4.1 Tubing. Teflon, 6.4 mm outside
diameter, separate pieces marked for each
calibration consentration.
4.4.2 Tedlar or Aluminized Mylar Bags. 50
L capacity, with valve; separate bag marked
for each calibration concentration.
4.4.3 Syringes. 1.0 fiL and 10 jiL, gas tight,
individually calibrated to dispense liquid
benzene.
4.4.4 Dry Gas Meter, With Temperature
and Pressure Gauges. Accurate to ±2
percent, to meter nitrogen in preparation of
standard gas mixtures, calibrated at the flow
rate used to prepare standards.
4.4.5 Midget Impinger/Hot Plate
Assembly. To vaporize benzene.
5. Reagents
Use only reagents that are of
Chromatographic grade.
5.1 Analysis. The following are needed
for analysis:
. 5.1.1 Helium or Nitrogen. Zero grade, for
chromatograph carrier gas.
5.1.2 Hydrogen. Zero grade.
5.1.3 Oxygen or Air. Zero grade, as
required by the detector.
5.2 Calibration. Use one of the following
options: either 1.2.1 end 5.2.2, or 5.2.3.
5.2.1 Bsnzene, B8 Mol Percent Pure.
Certified by the manufacturer to contain Q
minimum of 69 Mol percent benzene; for use
in the preparation of standard gas mixtures
as described in Section 7.1.
5.2.2 Nitrogen. Zero grade, for preparation
of standard gas mixtures as described in
Section 7.1.
5.2.3 Cylinder Standards (3). Gas mixture
otandards (50,10, and 5 ppm benzene in
nitrogen cylinders). The-tester may use
cylinder standards to directly prepare a
chromatograph calibration curve as
described in Section 7.2.2, if the following
conditions are met: (a) The manufacturer
certifies the gas composition with an
accuracy of ±3 percent or better (see Section
5.2.3.1). (b) The manufacturer recommends a
maximum shelf life over which the gas
concentration does not change by greater
than ±5 percent from the certified value, (c)
The manufacturer affixes the date of gas
cylinder preparation, certified benzene
concentration, and recommended maximum
shelf life to the cylinder before shipment to
the buyer.
5.2.3.1 Cylinder Standards Certification.
The manufacturer shall certify the
concentration of benzene in nitrogen in each
cylinder by (a) directly analyzing each
cylinder and (b) calibrating his analytical
procedure on the day of cylinder analysis. To
calibrate his analytical procedure, the
manufacturer shall use, as a minimum, a
three-point calibration curve. It is
recommended that the manufacturer maintain
(1) a high-concentration calibration standard
(between 50 and 100 ppm) to prepare his
calibration curve by an appropriate dilution
technique; and (2) a low-concentration
calibration standard (between 5 and 10 ppm)
to verify the dilution technique used. If the
difference between the apparent
concentration read from the calibration curve
and the true concentration assigned to the
low-concentration standard exceeds 5
percent of the true concentration, the
manufacturer shall determine the source of
error and correct it, then repeat the three-
point calibration.
5.2.3.2 Verification of Manufacturer's
Calibration Standards. Before using, the
manufacturer shall verify each calibration
standard by (a) comparing it to gas mixtures
prepared (with 89 Mol percent benzene) in
accordance with the procedure described in
Section 7.1 or by (b) having it analyzed by the
National Bureau of Standards. The agreement
between the initially determined
concentration value and .the verification
concentration value must be within ±5
percent. The manufacturer must reverify all
calibration standards on a time interval
consistent with the shelf life of the cylinder
otandards sold.
5.2.4 Audit Cylinder Standards (2). Gas
mixture standards with concentrations
known only to the person supervising the
analysis of samples. The audit cylinder
standards shall be identically prepared as
those in Section 5.2.3 (benzene in nitrogen
cylinders). The concentrations of the audit
cylinder should be: one low-concentration
cylinder in the range of 5 to 20 ppm benzene
and one high-concentration cylinder in the
range of 100 to 300 ppm benzene. When
available, the tester may obtain audit
cylindero by contacting: U.S. Environmental
Protection Agency, Environmental Monitoring
. and Support Laboratory, Quality Assurance
Branch (MD -77). research Triangle Park.
North Carolina 27711. If audit cylinders are
not available at the Environmental Protection
Agency, the tester must secure an alternative
•source.
ft Procedure
B.I Sampling. Assemble the sample train
as shown in Figure 110-1. Perform a bag leak
check according to Section 7.3.2. Join the
quick connects as illustrated, and determine
that all connections between the bag and the
probe are tight. Place the end of the probe at
the centroid of the stack, and start the pump
with the needle valve adjusted to yield a flow
that will more than half fill the bag in the
specified sample period. After allowing
sufficient time to purge the line several times.
connect the vacuum line to the bag and
evacuate the bag until the rotameter indicates
no flow. At all times, direct the gas exiting
the rotameter away from sampling personnel.
At the end of the sample period, shut off the
pump, disconnect the sample line from the
bag, and disconnect the vacuum line from the
bag container. Protect the bag container from
sunlight.
6.2 Sample Storage. Keep the sample bags
out of direct sunlight. Perform the analysis
within 4 days of sample collection.
0.3 Sample Recovery. With a new piece of
Teflon tubing identified for that bag. connect
a bag inlet valve to the gas chromatograph
sample valve. Switch the valve to receive gas
from the bag thrpugh the sample loop.
Arrange the equipment so the sample gas
passes from the sample valve to a IGO-mL/
min rotameter with flow control valve
followed by a charcoal tube and a 1-in.
pressure gauge. The tester may maintain the
sample flow either by a vacuum pump or
container pressurization if the collection bag
remains in the rigid container. After sample
loop purging is ceased, always allow the
pressure gauge to return to zero before
activating the gas sampling valve.
8.4 Analysis. Set the column temperature
to 80' C (176° F) for column A or 75" C (167°
F) for column B, and the detector temperature
to 225° C (437° F). When optimum hydrogen
and oxygen flow rates have been determined.
verify and maintain these flow rates during
all chromatograph operations. Using zero
helium or nitrogen as the carrier gas,
establish a flow rate in the range consistent
with the manufacturer's requirements for
satisfactory detector operation. A flow rate of
approximately 20 mL/min should produce
adequate separations. Observe the base line
periodically and determine that the noise
level has'stabilized and that base-line drift
has ceased. Purge the sample loop for 30 sec
at the rate of 100 mL/min, then activate the
sample valve. Record the injection time (the
position of the pen on the chart at the time of
sample injection), the sample number, the
sample loop temperature, the column
temperature, carrier gas flow rate, chart
speed, and the attenuator setting. From the
chart, note the peak having the retention time
corresponding to benzene, as determined in
Section 7.2.1. Measure the benzene peak area.
AQ, by use of a disc integrator, electronic
integrator, or a planlmetsr. Record AQ and
V-H-21
-------
Federal Register / Vol 45. No. 77 / Friday. April 16. 1980 / Proposed Rules
the retention time. Repeat the injection at
least two times or until two consecutive
values for the total area of the benzene peak
do not vary more than 5 percent. Use the
average value of these two total areas to
compute the bag concentration.
6.S Determination of Bag Water Vapor
Content. Measure the ambient temperature
and barometric pressure near the bag. Prom a
water saturation vapor pressure table,
determine and record the water vapor
content of the bag as a decimal figure.
(Assume the relative humidity to be 100
percent unless a lesser value is known.)
7. Preparation of Standard Cos Mixtures,
Calibration, and Quality Assurance
7.1 Preparation of Benzene Standard Gas
Mixtures. (Optional procedure—delete if
cylinder standards are used.) Assemble the
apparatus shown in Figure 110-2. Evacuate a
SO-L Tedlar or aluminized Mylar bag that has
passed a leak check (described in Section
732.) and meter in about SO L of nitrogen.
Measure the barometric pressure, the relative
pressure at the dry gas meter, and the
temperature at the dry gas meter. While the
bag is filling, use the IQjiL syringe to inject
lOfiL of 09+ percent benzene through the
septum on top of the impinger. This gives a
concentration of approximately 50 ppm'of
benzene. In a like manner, use the other
syringe to prepare dilutions having
approximately 10 ppm and S ppm benzene
concentrations. To calculate the specific
concentrations, refer to Section 8.1. These gas
mixture standards may be used for 7 days
bom the date of preparation, after which time
preparation of new gas mixtures is required.
(Caution: If the new gas mixture standard is a
lower concentration than the previous gas
mixture standard, contamination may be a
problem when a bag is reused.)
7.2 Calibration.
7.2.1 Determination of Benzene Retention
Time. (This section can be performed
simultaneously with Section 7.2.2.) Establish
chromatograph conditions identical with
those in Section 6.4, above. Determine proper
attenuator position. Flush the sampling loop
with zero helium or nitrogen and activate the
sample valve. Record the injection time, the
sample loop temperature, the column
temperature, the carrier gas flow rate, the
chart speed, and the attenuator setting.
Record peaks and detector responses that
occur in the absence of benzene. Maintain
conditions, with the equipment plumbing
arranged identically to Section 6.3, and flush
the sample loop for 30 sec at the rate of 100
mL/min with one of the benzene calibration
mixtures. Then activate the sample valve.
Record the injection time. Select the peak
that corresponds to benzene. Measure the
distance on the chart from the injection time
to the time at which the peak maximum
occurs. This distance divided by the chart
•peed is defined as the benzene peak
retention time. Since it is quite likely that
there will be other organics present hi the
sample, it is very important that positive
identification of the benzene peak be made.
V-H-22
-------
Federal Register / Vol. 45. No. 77 / Friday, April 18.1980 / Proposed Rules
SYRINGE
SEPTUM
DRY GAS METER
TEDLAR BAG
CAPACITY
50 LITERS
Figure 110-2. Preparation of benzene standards (optional).
V-H-23
-------
m, Dfo. Tf I Mday, ApaJ SO, HOO / gtegxgosdl
(fr&stioh.
7.2.Z Preparation of Chromatograph
Calibration Curve. Make a gas
Chromatographic measurement of eesfci
ctandard gao mixture (described in Section
5.2.3'or 7.1.1) using conditions identical with
these listed in Sections 8.3 and 6.4. Flush the
oampling loop for 30 oec at the rate of mL/
saia with one of the otaajSord goo Esixtaso
and activate the oampa volvo. Record Cc, the
concentration of benzene injected, the
attenuator dotting, chart spasd, peak area.
caraple loop temperature, colsann
teaperaturs, carriKT gas flow rate, and
retention time. Record the laboratory
pressure. Calculote At, the peak area
multiplied by the attenuator setting. Repeat
tantil two consecutive injection areao are
within 5 percent, then plot the average of
those two values verous C,. When the other
standard gas mixtures have been similarly
analyzed and plotted, draw a straight line
through the points derived by the least
oquares method. Perform calibration daily, or
Ibsfore and after each set of bag samples,
whichever ia more frequent.
7.3 Quality Assurance.
7.3.1 Analysis Audit. Immediately after
the preparation of the calibration curve and
before the sample analyses, perform the
onalysio aeSJl deocHbed in Appendix E, • •";
: "Procedure for Field Auditing
7.S.2 EOQ Leak Checks. While
performance of this cection is required after
bag use, it b also advised that it be
performed before bag use. After each use,
make ouro o Ssag did not develop leaks by
connecting Q water manometer and
IjSfaoourisisg She bag to S to 10 cm HcO (2 to 4
in. HoOJ. Allow to otand for 10 min. Any
dioplacamsnt ia the water manometer
indicates a leak. Abo, check the rigid
eesatainer to? leeks in thio manner. (Note: an
alternative leak check method is to pressurise
the bag to 5 to SO cm H0O or 2 to 0 in. H0O
and allow to otand overnight. A deflated bag
indicates a leak.) For each sample bag in its
rigid container, piece a rotameter in line
between'tbe bag and the pump inlet.
Evacuate the bag. Failure of the rotameter to
register zero flow when the bag appears to be
empty indicates a leak. . .
8. Calculations
8.1 Optional Benzene Standards
Concentrations. Calculate each benzene
otandard concentration [Q in ppm) prepared
in accordance with Section 7.1 as follows:
B(0.2706)(lin.
293
755
701.9
BT
(110-1)
where:
0.2706
103
8.2
= Volume of benzene injected, raicroliters. . . .
= Gas volume measured by dry gas meter, liters.
= Dry gas meter calibration factor, dimensionless.
= Absolute pressure of the dry gas meter, nunHg.
= Absolute temperature of the dry gas meter, °K.
= Ideal gas volume of benzene at 293° K and 760 nunHg I/mi.
= Conversion factor [(ppm)(mL)AjL].
Benzene Sample Concentrations. From the calibration curve de-
scribed in Section 7.2.2 above, select the value of C that corresponds to
AC> Calculate the concentration of benzene in the sample (C in ppm) as
follows:
_
PiTr
(110-2)
oftsre:
Tr
wb
- Concentration of benzene in the sample, ppm.
= Concentration of benzene indicated by the gas Chromatograph,
ppm.
= Reference pressure, the barometric pressure recorded during
calibration, mraHg.
s Sample loop temperature at the time of analysis, °K.
= Barometric pressure at fcirae of analysis, canHg.
=. Reference temperature, the sample loop temperature recorded
during calibration, °K.
- Hater vapor content of tho bag sersple, volume fraction.
' ft ' References "'
S. Feairheller, W. R., A. H Kemmer, B. J.
Werner, and D. Q. Douglas.
Measurement of Gaseouo Organic
(CoEapotsnd Bsaiooicaa by Gas
Chromatography. U.S. Environemental
Protection Agency. EPA Contract
Number 88-02-KilM. Joauary 107B.
Revised by EPA August S078. '
2. Knoll. Jocsph E. Wade H. Penny, and
Rodney M. Midgett. The Use of Tedlar
Bags to Contain Gaseous Benzene
Samples at Source Lsvel. U.S.
Environmental i?rotection Agency.
Research Triangle Pork, N.C. Monitoring
Series, EPA-«flO/
-------
Federal Register / Vol. 45. No. 77 / Friday, AndJ 18,1360 J Propoted Rule*
The following calculation steps are required:*
1.
2
3.
4
2o
(b-2os)/oc
(b+2os)/oc
r-r,x
— I e
ifZn j
7
8.
dx
- Q(x2)
»oVAs
9. Percentage overlap = A x 100
where
The area of the sample peak of interest determined by elec-
tronic integration, or by the formula AS = hst&. .
The area of the contaminant peak, determined in the sane
manner as A .
The distance on the chromatographic chart that separates the
maxima of the two peaks.
The peak height of the sample compound of interest, measured
from the average value of the baseline to the maximum of the
curve.
The width of the sample peak of interest at 1/2 of peak
height.
The width of the contaminant peak at 1/2 of peak height.
The standard deviation of the sample compound of interest
elution curve.
The standard deviation of the contaminant elution curve.
The integral of the normal distribution function fro* Xj to
infinity.
The integral of the normal distribution function fro* x; to
Infinity.
The overlap Integral.
The area overlap fraction.
In judging the suitability of alternate gas
chromatographic colamns. or the effects of
altering chrcinatographic conditions, one can
employ the area overlap as the resolution
parameter with a specific maximum
permissible value.
The use of Gaussian functions to describe
chromatographic elution curves is
widespread. However, some elution curve*
are highly asymmetric. In those cases where
the sample peak is followed by a
contaiminant that has a leading edge that
rises sharply but the curve then tails off, it
may be possible to define an effective width
for I* as "twice the distance from the leading
edge to a perpendicular line through the
maxim of the contaminant curve, measured
aloqg a perpendicular bisection of that line."
Supplement B—Procedure for Field Auditing
GC Analysts
Responsibilities of audit supervisor and
analyst at the source sampling site include
the fallowing:
A. Check that audit cylinders are stored in
B safe location both before and after the audH
to prevent vandalism of same.
B. At file beginnmg and conclusion of the
audit record each cylinder number and
cylinder pressure. Never analyze an audit
cylinder when the pressure drops below 200
psi.
C. During the audit, the analyst is to
perform a minimum of two consecutive
analyses of each audit cylinder gas. The audit
must be conducted to coincide with the
analysis of source test samples. Normally, it
will be conducted immediately after the GC
calibration and prior to the sample analyses.
D. At the end of audit analyses, the audit
supervisor requests the calculated
concentrations from the analyst and then
compares the results with the actual audit
concentrations. If each measured
concentration agrees with the respective
actual concentration within ±10 percent he
then directs the analyst to begin the analysis
of source samples. Audit supervisor Judgment
and/or supervisory policy determine course
of action with agreement is not within ±10
percent. Where a consistent bias in excess of
10 percent is found, it may be possible to
proceed with the sample analyses, with a
conective factor to be applied to the results
at a later time. However, every attempt
should be made to locate the cause of the
discrepancy, as it may be misleading. The
audit supervisor is to record each cylinder
number, cylinder pressure (at the end of the
audit), and all calculated concentrations. The
individual being audited must not under any
circumstance be told the actual audit
concentrations until the calculated
concentrations have been submitted to the
audit supervisor.
•In most Instances, Q(x2) It very small and My be neglected.
V-H-25
-------
<
I
I
FIELD AUDIT REPORT
PART A - To be filled out by organization supplying audit cylinders
1. Organization supplying audit sample(s) and shipping address
2. Audit supervisor, organization, and phone number
3. Shipping instructions: Name, Address, Attention
4.
5.
6.
Guaranteed arrival date for cylinders
Planned shipping date for cylinders
Details on audit cylinders from last analysis
Low Cone. High Cone.
a. Date of last analysis
Cylinder number
Cylinder pressure, psl
Audit gas(es)/balance gas
Audit gas(es) ppm
Cylinder construction
PART 8 - To be filled out by audit supervisor
Process sampled
1.
2.
Location of audit
3. Name of Individual audited
4. Audit date
5. Audit results
a. Cylinder number
b. Cylinder pressure before
audit, psi
c. Cylinder pressure after
audit, psi
d. Measured concentration, ppm
Injection #1*
Injection #2*
Average*
e. Actual audit concentration, ppm
(Part A, 6e)
f. Audit accuracy*
Low Cone. Cylinder
High Cone. Cylinder
'Percent accuracy -
Low Cone.
Cylinder
High Cone.
Cylinder
Cone.
x 100
«
o
Z
o
Q.
CD
3.
>->
OB
g. Problems detected (if any)
I
n
09
'Results of two consecutive injections that meet the sample analysis
criteria of the test method.
-------
ENVIRONMENTAL
PROTECTION
AGENCY
NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
POLICY AND PROCEDURES FOR
IDENTIFYING, ASSESSING AND
REGULATING AIRBORNE SUBSTANCES
POSING A RISK OF CANCER
APPENDIX C
-------
Eogsste? / Vol. 44, No. 197 / Wednesday. October 10. 1979 / Proposed Rules
[FRL 1258-1]
OJatoinal Etvilootofi) Standards for
Ale
tor tdonWylng, Assessing,
: Environmental Protection
Agency.
: Proposed rulemaking.
SUMMARY: This notice proposes for
comment a rule governing the policies
and procedures to be used by the
Environmental Protection Agency in the
identification, assessment, and
regulation under the Clean Air Act of
substances which, when emitted into the
ambient air for stationary sources,
increase the risk of cancer to the general
population. The proposed policy
implements for the air program of EPA
the principles adopted by the President's
Regulatory Council in a statement
issued September 28, 1979 on the
regulation of chemical carcinogens. In
concert with this proposal, EPA is
publishing elsewhere in today's Federal
Register an advance notice of proposed
rulemaking soliciting comments on draft
generic work practice and operational
standards which could be applied
quickly to reduce emissions of airborne
carcinogens from certain source
categories.
Under the proposed policy, EPA
would evaluate available information to
identify those substances, including
radioactive materials, which should be
considered for regulation under the
Clean Air Act as airborne carcinogens.
Any air pollutant determined to present
a significant carcinogenic risk to human
health as a result of air emissions from
one or more categories of stationary
sources would be listed under section
112 as a hazardous air pollutant. Listing
under section 112 would be
accompanied, where applicable, by the
proposal of generic standards for source
categories producing or handling
significant quantities of the substance.
The generic standards would rapidly
effect reasonable control of emissions
while more detailed analyses are
performed to establish priorities for
further regulation, determine available
control technology, and assess
regulatory impacts.
Final standards for source categories
presenting significant risks to public
health would, as a minimum, require
such sources to use best available
technology to reduce emissions. If,
however, the risk remaining after the
application of best available technology
is determined to be unreasonable,
further control would be required.
Unreasonable residual risk
determinations would considsr the risk
remaining, the benefits conferred by the
substance or activity, the distribution of
those benefits versus the distribution of
risks, the availability of substitutes, the
costs of further control of the substance
or source categories, and propooed cites
irNthe case of new sources. Standards
would be reviewed at no more than five-
year intervals.
©flYSS: Written comments should be
postmarked no later than February 7,
1980.
Notice of intent to appear at a public
hearing should be postmarked no later
than November 26, 1979. Hearing dates
and locations, which will be held during
the comment period, will be announced
in the Federal Register.
Written comments responding to,
supplementing, or rebutting written or
oral comments received at public
hearing must be made within 60 days of
the hearing date.
AO0BSS8ISS: All written comments
should be addressed to: Central Docket
Section. Room 2803B, Waterside Mall,
401 M Street, SW., Washington, B.C.
20460, ATTN: OAQPS 79-14.
EPA has established a rulee&king
docket consistent with procedures
established by section 307(d)(t)(N) of
the Clean Air Act (42 U.S.C. 7S07(d)).
The docket number is OAQPS 7B-S4 and
it already contains the documents OH
which this proposal is based. All
comments received during the comment
period, as well as any other documents
used in the promulgation of the final rule
will be added to the docket promptly.
The docket number should be on all
written comments. The docket will bs
open for inspection at the Central
Docket section at the above address
between 8:00 a.m. and 4 p.m. Monday
through Friday.
Notice of intent to appear at a public
hearing should be directed to: Joseph
Padgett, Director, Strategies and Air
Standards Division (MD-12),
Environmental Protection Agency,
Research Triangle Park, North Carolina
27711.
Additional copies of this notice are
available from: industry Assistance
Office, Office of Toxic Substances, U.S.
EPA, 401 M Street, SW., Washington,
D.C. 20460, 800-424-9085 (toll fres) (202)
554-1404.
Standards Division, (919) 541-5204, FTS
329-5204.
Availability of related information: Ao
described above, documents upon which
this proposal is based are available for
public inspection in the rulemaking
docket (OAQPS 78-14). In addition to
these materials, this notice includes a
osspplemental statement of basis and
jjKiirpose containing further discussion of
Jhe legal basis for the proposed policy.
v/arious alternative control strategies
considered, and comparisons with other
carcinogen policy proposals. This
statement follows the text of the
proposed rule.
L Background: The Need for a Policy
and a Regulatory Mechanism
A. Introduction
The principal focus of the nation's air
pollution control program to date has
been the establishment and
implementation of standards related to
oix major pollutant (particulate matter,
oulfur oxides, ozone, nitrogen oxides,
carbon monoxide, and lead). Recently,
increasing attention has been directed
towards those toxic components of 'air
pollution which may not be adequately
controlled by current programs.
Pollutants that may contribute to the
occurrence of human cancer have
received particular attention because of
the nature and seriousness of this group
of diseases, and because of recent
findings suggesting that a large number
of airborne chemicals and radionuclideo
to which people are exposed may be
implicated in cancer and other diseases
related to genetic damage. (1, 2, 3)
B. The General Cancer Problem
The nature and magnitude of the
cancer problem in the United States and
(She fact that radioactive agents and
oome chemicals can produce cancer in
animals and humans have been well-
documented and publicized. ' Some of
(foe more important aspects of the
occurrence and causes of cancer and the
role played by air pollution are briefly
summarized below.
(1) Nature and Magnitude of the
Problem (4, 5. 6. 7, 8)
Cancer is a group of diseases
characterized by the unrestrained
growth of cells that have somehow lost
an essential self-regulatory mechanism.
The uncontrolled growth of these cells
Eventually threatens the life of the host
. Cancer is currently the second
Joseph Padgett, Strategies and Air
'Detailed discussion of the general features of the
problem have been presented by the Occupational
Cofcty end Health Adminiotralion (4). (he Consumer
Product Safety Commission (5.). and others (tf).
V-Appendix C-2
-------
/ Vol. M. No. 197 / Wednesday. Octotef HO. 1S7® / Proposed Rules
leading cause of death in the United
States. One American in four is
expected to contact some form of cancer
in his or her lifetime, and one in five is .
expected to die from the disease. The
most recent statistics show a continued
Increase in total cancer incidence, due
principally to increases in lung cancer.
The social, economic, and human
costs of cancer are immense. Most forms
of cancer are difficult if not impossbile
to cure;, less than one-half of all cancer
patients live longer than five years from
the discovery of their illness. The
elusiveness of cures is due largely to the
fact that cancer's basic biological
mechanisms at the cellular level are not
well understood. Approximately 1.8
billion dollars are spent each year for
hospital care of cancer patients;
significant additional costs not readily
estimated include doctor's fees, out-
patient therapy, and drug costs. In
addition, it is estimated that 1.8 million
work-years are lost annually because of
cancer.
(2) Causes of Cancer: Importance of
Environmental Factors
Studies of human cancer rates, their
worldwide geographical variations, and
observations of incidence rates in
migrant populations have revealed that
factors in the human environment are
probably responsible for a large
proportion of cancers. "Environmental
factors" must be understood in the
broad sense to include chemical
exposures from smoking, diet,
occupation, drinking water, and air
pollution; various forms of radiation,
including sunlight; and some forms of
severe physical irritation. Although the
uncertainties are great, estimates by the
World Health Organization, other
prominent institutions, and individual
experts have suggested that 60 to 80
percent of all human cancers may be
due to these factors. (37.9.)
Studies of cancer incidence in
particular groups have shown strong
statistical relationships between
exposure to certain chemical or
radioactive substances and specific
cancers. The connection between
tobacco smoke and lung and other
cancers is the most widely known.(35)
Significant increases in leukemia and
other forms of cancer have been noted
among Japanese survivors of atomic
bomb explosions during World War II.
Markedly elevated cancer rates are
found among certain occupational
groups in the United States and other
highly industrialized countries. In
general, cancer rates are higher than
average in urban areas/20/ .
Unequivocal identification and
quantification of the specific factors that
lead singly or in combination with
factors to specific forms of cancer in
humans is, however, an extraordinarily
difficult task. Observation from human
experience is complicated by a number
of factors. Purposeful experimentation of
humans, for example, is ethically
unacceptable, since the result would
often be fatal. Definitive epidemiological
studies of occupationally exposed
groups are often difficult because the
relatively small population exposed and
inadequate information about duration.
magnitude, and circumstances of
exposures may not permit statistically
reliable conclusions to be drawn.
Studies of the cuases of cancer in the
general population may be equivocal
because of the complex modes of
exposure, low exposure levels, and
other complicating factors. In addition,
synergistic and antagonistic interactions
between chemicals substantially
complicate any conclusions about the
effects of a particular chemical.
Another major difficulty in the
interepretation of such studies is the
long latency period exposure to •
carcinogens, and onset of the disease.
Most cancers observed in today's
population probably had their origins in
exposures that began 15 to 40 years
ago/36,11) Thus, epidemiological
studies in current populations must
involve estimation of historical
exposures. The latency period also
means that epidemiology cannot detect
effects of relatively new substances
until years of exposure have occurred.
To date, epidemiological studies have
identified only 26 environmental agents
believed to increase cancer risks in
humans. (12). The casual relationships
implied by the statistical connections ia
these studies have generally been
supported by controlled experiments on
animals. With the possible exceptions of
benzene and arsenic, those factors
known to produce cancer in humans
also produce cancer in test animals.(34)
Animal experiments have also
implicated many additional chemical
substances as potential human
carcinogens.
In addition to the potential that a
substance acting alone may induce
cancer, there is evidence that exposure
to certain combinations of carcinogenic
and non-carcinogenic agents may
promote or potentiate the carcinogenic
response. The disproportionate risk of
lung caner to cigarette smokers
occupationally exposed to asbestos
Kbers(36,37) is an example of the
synergism of two known human
carcinogens. Non-carcinogenic and co-
carcinogenic substances may also act to
promote or enhance the human response
to carcinogen exposure.
Although airborne carcinogens may
induce cancer at a number of body sites,
lung cancer is thought to be the principal
form of cancer related to air
pollution/25/ While cigarette omoking is
probably-the most important cause of
lung cancer in the United States/is, 35)
many scientists believe that various air
pollutants increase the risk of cancer
from smoking and other carcinogenic
insults. Available estimates also
indicate that occupational exposures are
responsible for a significant portion of
lung cancer incidence in the United
StatesflO, 17).
Because of the difficulties inherent in
studying the causes of cancer and the
multifactorial nature of human
exposures, the role of each major
exposure pathway remains a matter of
some debate. While factors such as
smoking, occupational exposures, diet,
and solar radiation ere probably
responsible for a greater proportion of
cancers than ambient air pollution
alone, (10,13,14} the dimensions of the
problem posed by airborne carcinogens
remain significant. Besides their
contribution to cancers primarily related
to other pathways, airborne carcinogens
Shemselves pose risks to large numbers
of people. In certain industrialized
areas, especially, composite national
figures may mask significantly higher air
pollution-related cancer risks. And, in
the vicinity of specific sources of
carcinogenic emissions, risks to
individuals can reach very high levels.
A preliminary EPA examination of
chemical production, industries
producing radioactive materials, and air
sampling results has identified over fifty
known or potential chemical
carcinogens and numerous radioactive
materials which may be emitted to the
atmosphere. Many of these substances
are synthetic organic chemicals that
have been in commercial use only since
the 1930's. (18) Since cancer induced by
exposures to small amounts of airbone
carcinogens may not appear for 15 to 40
years after exposure, it is still too early
to detect the full impacts of these
chemicals on human health. Thus, it is
both prudent and, in view of the large
number of people potentially affected,
important to reduce or contain
emissions of known or suspected
atmospheric carcinogens in order to
prevent future problems before they
actually are observed.
V-Appendix C-3
-------
iFodoral Kegisier / Vol. 44,' No. 197 / Wednesday, October 10, 1970 / Proposed Rules
C. Problems in Regulating Airborne
Carcinogens
[1] Introduction
Although significant reductions in
emissions of airborne carcinogens have
resulted indirectly from control of
pollutants such as participate matter
(19) and volatile organic chemicals (20)
under sections 1G9 and 111 of the Cfean
Air Act,2 EPA has taken direct
regulatory action to control air
carcinogens primarily under section
112.8 Section 112, National Emission
Standards for Hazardous Air Pollutants
(NESHAPs), provides for the listing of
pollutants which in the judgement of the
Administrator cause or contribute to air
pollution which may seasonably be
anticipated to result in an increase in
mortality or an increase in serious
irreversible, or incapacitating reversible,
illness. After a substance is listed as a
hazardous air pollutant, EPA must
establish control requirements for
various source categories which emit the
substance. The standards must, in the
judgment of the Administrator, provide
an ample margin of safety to protect the
public health from such hazardous air
pollutants. Carcinogens that have been
listed under section 112 to date include
asbestos, beryllium,'3 vinyl chloride, and
benzene. A number of specific emission
source categories of these substances
4>ave been regulated. (21,22)
A number of scientific, technical, and
policy problems have arisen which
complicate the regulation of airborne
carcinogens under section 112.
Significant delays in establishing
standards have been associated with
determining the appropriate degree of
control for certain sources of listed
carcinogens. Although the determination
of whether and to what degree a
particular chemical presents a risk of
cancer to humans has not yet been a
significant source of delay under section
112, future disagreements are
anticipated. This may be particularly
true when dealing with substances for
which epidemiological data are not
available. These problems and their
consequences are discussed in the
following sections.
'42 U.S.C. Sectkuio 7409 and 7«ll.
'42 U.S.C. Section 7412. Since the dean Air Act
provides for separate treatment of mobile source
emissions under Title II, this policy addresses only
air emissions from stationary sources. At this time.
carcinogenic emissions from otationary sources
appear to present a larger and more diverse public
health problem than mobile source emissions.
' Beryllium was listed because of its non-
carcinogenic toxic properties.
(2) Difficulty in Determining
Carcinogenicity
The carcinogenic substances listed
under section 112 to date were
recognized as human carcinogens on the
basis of epidemiological evidence. For
most other chemical substances,
however, such evidence will not be
available, and other means of assessing
carcinogenicity will have to be
employed.
Protection of public health from
current and future cancer risks therefore
requires reliance on the results of
laboratory tests, primarily involving
animals, in the identification of probable
human carcinogens. Practical limitations
require that most animal tests be
conducted with much smaller numbera
of subjects than the human populations
they represent, and at doses much
nigher than ambient exposure levels to
improve the detectability of
carcinogenic effects.
Evaluation of the carcinogenic risk to
humans, based on such animal tests of
candidate substances, raises a number
of issues. Among Shese are the
differences between species,
extrapolation from the high doses
administered to animals to the iow
concentrations present in the ambient
air, differences in routes 6? exposure
(e.g., ingestion versus inhalation), the
significance of benign tumors, and the
question of no-
-------
fcgistef / Vol. 44, No. W7 j Wednesday, October W, 2S?79 /
the absence of identifiable effect
thresholds, carcinogens pose some risk
of cancer at any exposure level above
zero. The existence of risk at any
exposure level has created difficulty in
setting required control levels. Some
commenters have maintained that no
racks should be permitted from
emissions of carcinogens, while others
argue that, in view of the uncertainty
that any effect will occur at low
exposure levels, only feasible and
clearly cost-effective controls should be
required.
This difficulty has been compounded
by the language of section 112 itself,
which calls for the establishment of
standards which, in the judgment of the
Administrator, provide "an ample
margin of safety to protect the public
health" from hazardous air pollutants.
This language clearly mandates that the
primary factor in standard-setting under
section 112, in contrast to some other
sections of the Act, such as section 111,
be the protection of public health. How
this mandate should be translated into
standards for airborne carcinogens,
however, is not clear. This uncertainty
has led to delay and litigation, with
some arguing that the only factor that
may be considered is health effects,
while others contend that EPA should
simply balance risk against the cost of
control and the benefits of the activity.
giving all factors equal weight. While
EPA has made limited statements (21.
22} of its view of section 112, the
Administrator has not expressed a
comprehensive.interpretation of the
provision as it applies to the regulation
of carcinogens until now.
(5) EOF Petition
Citing concerns over the limited
number of carcinogens listed as
{Hazardous air pollutants to date and the
(regulatory delays encountered in
controlling vinyl chloride, the
Environmental Defense Fund (EOF), in
November 1977, petitioned EPA to adopt
a generic approach for classifying and
regulating carcinogenic air pollutants
mmder the Clean Air Act (30).
The EOF proposal is patterned on the
classification system proposed by
OSHA and is based on scientific criteria
similar to those articulated by CPSC.
OSHA. and EPA for carcinogenicity
determinations.6 Suspect substances
would be grouped into three categories
(confirmed, probable, possible) based on
the availability evidence of
carcinogenicity. Under the main feature
of the policy suggested by EOF. a
determination that an air pollutant is &
confirmed carcinogen would trigger the
following responses: (a) immediate
listing as a hazardous air pollutant
under section 112; said (bj proposal and
promulgation of regulations to (1) either
ban (the uoe oJ (the siateriaS if e suitable
substitute exists, or to require the
application of emissions or equipment
standards representing best available
control technology; (2) establish a
timetable leading to the reduction of
emissions to zero at both existing and
new sources; and (3) prevent any
increase on emissions from additions to
or replacements of existing facilities.
In March 1S78. EPA conducted a
public meeting to receive comments on
the EDF proposal and any other
suggestions regarding the Agency's
regulatory process for the control of
airborne carcimogens {31.32) °. One
major presentation made at that meeting
was by the American Industrial Health
Council }A1HC), advocating the use of a
central board of non-governmental
scientists for evaluating carcinogenicity
and carcinogenic potency of substances
of interest for all federal regulatory
agencies (33). The principles AIHC
recommended for determination of
carcincgemkalty differ somewhat from
those proposed by EPA, CPSC, and
OSHA. AIHC also recommended that
standards fee set independently for each
substance through a •process of
"balancing" predicted cancer incidence,
costs of control, and benefit of the
substance regulated. While AIHC gave
examples of alternative balancing
procudures which onaight be used, it did
not recoimed may specific course of
action to EPA (For aoe minder section 112.
(6) Need tax an Air Carcinogen Policy
The problems associated with the
determination of carcinogenicity, the
large number of potential carcinogens,
and the appropriate level of control of
emitting cowces contribute to delays in
decisions to list carcinogenic substances
as hazardous air {pollutants as well es to
delays in establishing control
requirements under section 112. Indeed.
EPA has listed only three air pollutants
as carcinogens under section 112 since
1970. Therefore, given the potentially
large number of airborne carcinogens
which may require control the general
unavailability of epidemiological data
for determining carcinogenicity and
potential risks, the requirements of
section 112, and EPA's experience under
section 112 to date, the Administrator
has concluded that the establishment of
'A comparison of these approaches is presented
in the [supplemental statement which follows the
•«•»( of «Ka proposed rule.
"The commento received at that meeting have
baen conoiderad in the formulation of today'o
propoAal.
a comprehensive and coherent policy
and set of procedures for regulatory
action is dealing with airborne
carcinogens is imperative.
Specifically, publidy-stated, legally
bmduig policies and regulatory
mechanisms are needed for (1)
determining the carcinogenicity and
carcinogenic risks of air pollutants for
regulatory purposes; (2) establishing
{priorities for evaluating the need for and
accomplishing additional regulatory
action: (3) specifying the degree of
control required in general under section
112 and how that level of control will be
determined in setting individual
standards; and (4) providing more
extensive public involvement in the '
Agency's decisionmaking on the
regulation of airborne carcinogens.
Among the benefits of adopting such a
policy, in addition to more expeditious
control of probable carcinogens, are
increased public understanding of and
participation in EPA'o actions end the
providing of earlier notice of EPA's
findings and intent to state and local
regulatory authorities and to industries.
H. EiscusshsB «&f Q8aQ IPirOjposed Rail®
A. Introduction
The provisions of &8s® proposed rule
are stated formally at the end of this
notice. The following sections present
dJie Agency's rationale for, and describe
the operation of, the proposed policy.
Certain related issues, including the
detailed legal basis of the proposal, the
consideration of various alternatives.
and a comparison vrith other policies,
are discussed in a supplemental
statement of basis and purpose
following the tent off the proposed rule.
Th
-------
Register / Vol. 44, No. 197 / Wednesday. October 10. 1979 / Propose^ Rules
B. Identification and Preliminary
Evaluation of Health Risks
This section describes the principles
and procedures that EPA will use in
identifying potential airborne
carcinogens and in determining whether
emissions of such substances pose
significant risks to public health. These
principles and procedures address
determinations in three fundamental
areas: (1) the generic determination that
the presence of airborne carcinogens in
relatively low ambient concentrations
warrants regulatory action, (2) the
identification of specific candidate
substances for EPA assessment, and (3)
the assessment of whether such
substances pose significant risks to
public health.
(1) The Need for Concern About
Relatively Low Doses
The Administrator's belief that
ambient concentrations of carcinogens
represent a significant public health risk
warranting regulatory action is based on
the current understanding of the
biological effects of these substances at
low concentrations. Essentially, two
hypotheses exist. The non-threshold
hypothesis assumes that cancer can
result from the interaction of as little as
one molecule of a carcinogen with a
critical receptor in one cell.
The threshold hypothesis, in contrast,
assumes that there is a no-effect dose of
a carcinogen below which induction of
cancer cannot occur. This hypothesis
argues that, at small doses, chemical .
carcinogens can be detoxified through
metabolic processes, resulting in some
level of exposure which produces no
carcinogenic response, or that repair
mechanisms or cell death may prevent
the development of cancer from a single
damaged ce\l.(23)
The public health community has
generally concluded that evidence for
identifiable dose thresholds does not
exist for carcinogens. Under this view,
any exposure to a carcinogenic
Qubstance carries a risk of cancer. A
recent report by the National Academy
of Sciences/24./ offers the following
observations in support of this
conclusion:
Consideration of the Dose-Response
Relationship. In considering the possibility of
thresholds for carcinogenesis, it ia important
to understand that there is no agent,
chemical, or physical, which induces in man
a form of cancer that does not occur in the
absence of that agent. In other words, when
there is exposure to a material, we are not
starting at an origin of zero cancers. Nor are
vte starting at an origin of zero carcinogenic
agents in our environment. Thus, it is likely
that any carcinogenic agent added to the
environment will act by a particular
mechanism on a particular cell population
that is already being acted on by the same
mechanism to induce cancers. This reasoning
implies that the only way for a new
carcinogen added to the environment to have
a threshold in ito dooe-response curve would
be if it were acting by a mechanism entirely
different from that already being experienced
by that tisoue.
Examination of Experimental Dooe-
Responoe Curves. The most extensive
information on carcinogenesis both in
experimental animals and in humans is with
ionizing radiation. Although there ia evidence
implicating thresholds in some animal
tissues, thresholds have in general not been
established for most tissues. If such
thresholds exist, they occur at sufficiently
low doses that it would require massive,
expensive, and impracticable experiments to
establish them. In view of the common
finding—for example, e linear dose-response
relationship (unaffected by dose-rate)—of
cancer induction in animals by high LET
[Linear Energy Transfer] radiation, it is
unlikely that such thresholds exist. Linearity
is not essential to the no-threshold argument
since nonlinear, dose-response relationships
do not necessarily imply the existence of
thresholds. . .
' Heterogeneity of the Population. The
human population in the United States—the
population we are trying to protect—is a
large, diverse, and genetically heterogeneous
group exposed to e variety of toxic agents.
Genetic variability to carcinogenesio is well-
documented (Strong, 1976), and it is also
known that individuals who are deficient in
immunological competence (for genetic or
environmental reasons) are particularly
susceptiple to some forms of cancer (Cottier,
et al., 1974).
It seems, therefore, that even if we were to
postulate an average threshold for a
particular cancer induced by a particular
agent, we would in practice need a aeries of
thresholds for different individuals. It would
ba extremely difficult, in practice, to establish
a single threshold.
We conclude from these arguments that,
despite all the complexities of chemical
carcinogenesis, thresholds in the dose-
response relationships do not appear to exist
for direct-acting carcinogens. If they do exist,
they are unlikely to be detected and, hence,
impossible to use. This means that there can
be no totally "safe" exposure to a particular
carcinogen. (Emphasis added.)
EPA has therefore made e generic
determination that, in view of the
existing state of scientific knowledge,
prudent public health policy requires
that carcinogens be considered for
regulatory purposes to pose some finite
risk of cancer at any exposure level
above zero. The Administrator believes
that this is consistent with the mandate
of section 112 requiring the protection of
public health against air pollutants
which "may reasonably be anticipated"
to cause or contribute to the health
effects of concern, and the application of
an "ample margin of safety" in making
ouch public health judgments.
(2) Identification and Screening of
Potential Airborne Carcinogens
Potential airborne carcinogens are
now and will continue to be identified
through various EPA programs,
including searches of the scientific
literature, monitoring studies, and
biological assays of substances found in
ambient air and source emissions, as
well as by examining information
obtained from federal, state, or other
regulatory authorities, private research
groups, and other scientific sources.
Suspect substances (compounds or
mixtures) identified in this manner will
be screened to provide a rough estimate
of the potential extent of public
exposure resulting from ambient air
emissions. Screening is essential for two
reasons: first, to optimize the use of
Agency resources in view of the growing
number of substances of concern, and
second, to distinguish between those
substances which may, through their
presence in the air, present carcinogenic
risks and those which, although
probably carcinogenic, ere not emitted
in quantities sufficient to pose such
risks.
Readily available information will be
collected on the intentional and
inadvertent production of such
substances and their uses, volatility, and
other chemical and physical properties.
Ambient air measurements and previous
scientific assessments will be
considered where available.
Appropriate offices within EPA and
other relevant agencies will be
contacted to determine whether any
regulatory actions, assessments, or
screening activities are underway.
Suspect substances to which the
screening process indicates the public is
probably exposed through ambient air
will receive further attention to evaluate
the likelihood that they pose significant
carcinogenic risks. Priorities for these
evaluations will be assigned based on
the expected potential for public
exposure to the substances. In some
cases, EPA may determine after
screening that regulatory actions under
other laws administered by EPA or by
other regulatory agencies eliminate the
need for further EPA action under the
Clean Air Act. Otherwise, potential
airborne carcinogens will be evaluated
for the likelihood that they pose
significant risks to public health.
These procedures are already in
operation. As noted above, screening of
over 140 potential airborne carcinogens
has yielded of 40 for which
carcinogenicity determinations and
preliminary exposure assessments are
underway. These determination!) are
V-Appendix C-6
-------
Federal Register / Vol. 44, No. 187 / Wednesday, October 10, 1079 /' Ffoposed SRrales
excepted to be largely completed by
December 1979.
(3J Evaluation of Significance of Risk to
Public Health7
The determination of significant
carcinogenic risk will be based on
assessments in two areas: the
probability that the substance is a
human carcinogen, and the extent of
human exposure via the ambient air.
(a) Evaluation of the Probability of
Human Carcinogenicity. The criteria for
evaluating the probability that an
airborne substance presents a
carcinogenic risk to humans are not
unique to the air, but are conceptually
the same as those for substances
present in any exposure medium. It
would thus be inappropriate for EPA to
use a novel set of criteria for airborne
substances alone. Accordingly, in
determining the carcinogenic risk posed
by air pollutants. EPA will use the
criteria specified in general guidelines
adopted by the Agency. The EPA
"Interim Guidelines for Carcinogen Risk
Assessment" ("Interim Guideline")
issued on May 25.1976 (25) outlines the
basic scientific criteria and policy
judgments currently used by EPA in
evaluating evidence regarding suspect
carcinogens. This guidance is
supplemented by the recent release for
comment by the Risk Assessment Work
Group of the Interajjency Regulatory
Liaison Group (IRLG)Bof a scientific
review of the principles and methods
applicable to the identification and
assessment of human risk from
carcinogens. (26)
Jn evaluating the likelihood that a
substance is carcinogenic in humans
under EPA's Interim Guideline and the
IRLG Work Group report, available
information is considered and judgments
concerning the probability of human
carcinogenicity are made based on the
quality and weight of evidence. The
information principally relevant to such
an evaluation includes epidemiological
and animal or other laboratory studies.
'Today's notice deals only with the carcinogenic
hazards of an air pollutant. A substance may also
Its regulated under section 112 due to its non-
carcittcgenic health effecto. or due to a combination
d carcinogenic and other serious effects. Non-
carcinogenic effects of substances being reviewed
us possible airborne carcinogens will also be
evaluated and considered where information on
those effects u> available.
"IRLG Agencies include Environmental
Protection Agency. Occupational Safely and Health
Administration. Consumer Product Safely
Coramisokm. Food and Drug Administration, and
Foods Safety and Quality Service (U.S. Department
of Agriculture). The Occupational Safely and Health
Administration, however, did not participate in the
joint issuance of the Risk Assessment Work Croup
report.
The available information is
evaluated in light of the following
criteria:
Judgments about the weight of evidence
involve considerations of the quality and
adequacy of the date and the kinds of
responoeo inducod by the ouopsct carcinogen.
The best evidence that on agent to a human
carcinogen comeo (From epidemiological
otudieo in conjunction with confirmatory
animal testo. Substantial evidence is
provided by animal tests that demonstrate
the induction of malignant tumors in one or
more species including benign tumors that
ere generally recognized as early stages of
raalinandes. Suggestive evidence includes
the induction of only those non-life-shorting
benign tumors which ere generally accepted
as not progressing to malignancy and indirect
tests of tumorigenk: activity, such as
mutagenicity. in vitro cell transformation,
and initiation-promotion skin tests in mice.
' Ancillary reasons that bear on judgments
about carcinogenic potential, e.g., evidence
from oystewiatic otudies that relate chemical
structure to carcinogenicity, should be
included in the assessment. (25)
This "weight of evidence" evaluation
outlined in the Interim Guideline does
not involve automatic categorization of
carcinogenic probability, but rather
evaluates the nature of the evidence in
each case. Once the evidence has been
weighted, o? course, the conclusions
must be useful for regulatory decisions.
For this reason, substances which have
been evaluated will be grouped into
three broad categories {high, moderate,
low) according to the probability of
carcinogenicity. Assignment to a
particular regulatory category will be
made on a case-by-case basis, and will
reflect the strength of the evidence that
the substance in question is a human
carcinogen in comparison with the range
of other subodances which have been
evaluated for regulatory action. In
general, substances for which "best" or
"substantial evidence" as described
above exists will be considered for
designation as high-probability human
carcinogens for purposes of section 112.
Substances for which only "suggestive"
evidence exists will be considered for
designation ao moderate-probability
human carcinogens. Substances for"
which only "ancillary" evidence exists
will be considered for designation as
low-probability human carcinogens.
EPA recognises that a range of
scientific uncertainty exists within these
broad evidentiary classes. For example,
a substance which has been found to be
carcinogenic to all animal species and
sexes tested may be more likely to be
carcinogenic in humans than a
substance tested in several species and
found to produce tumors in only one sex
of one spedeo. Although upon
consideration of the relative strength of
evidence it may be concluded that both
substances should be considered high-
probability human carcinogens, the
extent of uncertainty W'W be considered
on a case-by-case basis.
(b) Preliminary Evaluation of
Ambient Exposure. EPA will also
determine whether a suspect airborne
carcinogen is emitted into or present in
the ambient air in such a way that
significant human exposure results.
While the threshold of significance for
the ambient exposure determination will
be relatively low. oome consideration of
exposure levels is appropriate to avoid
initiating regulatory action under the
Clean Air Act for substances such as
"laboratory curiosities" which are very
unlikely to be present in the ambient air
in measureable quantities. This
preliminary exposure evaluation is
designed to make that distinction.
In the preliminary assessment of
ambient exposure, EPA will consider
available data on ambient
concentrations of the substance, the
number and nature of emitting sources.
and the number of people living near the
sources or in areas in which ambient
concentrations have been reported.
Where possible, preliminary estimates
of lifetime individual risks to the
potentially.snost exposed individuals.
based on estimates of carcinogenic
strength, will also be calculated.
The preliminary exposure assessment
will not be designed to produce the more
detailed information appropriate in
deciding what control measures may be
necessary, that information, including
detailed quantitative assessments of
risk, will also be developed where
possible by EPA, but is not required for
the determination of significant ambient
exposure.
C. Initial Responses to Preliminary
Assessments of Health Risks
The evaluation of the significance of
risk to public health will be used to
identify those substances for which, in
the judgment of the Administrator, there
is sufficient evidence to warrant listing
under section 112 as airborne
carcinogens. For substances which fall
short of meeting the criteria for this
determination, or for which available
information is not sufficient to make a
determination, the proposed policy
provides for alternative responses. The
following paragraphs describe EPA's
specific responses to various possible
evaluations under the proposed rule.
(1) Listing Under Section 112: Significant
Risk
Any oubtance judged by the
Administrator to present significant
carcinogenic risks to the public will be
V-Appendix C-7
-------
SB- / Vol. 44. No. 197 / Wednesday. October 10. 1979 / Proposed Rules
listed under section 112 as a hazardous
air pollutant. The finding of significant
carcinogenic risk is based on the
judgment that a substance has a high
probability of human carcinogenicity,
and evidence of significant public
exposure via the ambient air from
emissions from one or more categories
of stationary sources. •
A high-probability carcinogen may.
also be listed under section 112 if a
preliminary quantitative risk assessment
suggests that there is a significant risk to
the potentially most exposed groups as a
result of emissions of the substance.
These preliminary assessments of risk
will be considered as supplemental
evidence that listing is warranted where
the available evidence before the
Administrator is otherwise insufficient
to indicate the existence of a significant
risk. In the judgment of the
Administrator, it would not be prudent
health policy to base a decision not to
list upon a preliminary risk estimate in
the presence of qualitative evidence of
significant human exposure.
The limitation of the role of these
preliminary risk assessments to
supplementary evidence in support of a
finding of significant-risk is based on the
Administrator's judgment that these
quantitative estimates are too imprecise
and uncertain to use as a factor in
deciding not to list a substance. The
Administrator does believe, however,
that despite their considerable
uncertainty it would be imprudent to
ignore assessments suggesting the
existence of significant risk, especially
in light of the limited direct
consequences of listing. The
Administrator's views concerning the
use of quantitative risk assessment
under this proposal are discussed in
greater detail elsewhere in this notice.
The timing of the listing decision for a
given airborne carcinogen will depend
on the nature of the information
available to the Administrator. Initially
available information will often be
adequate to conclude that emissions of
the sustance present a significant risk to
the public. If so, listing would occur
immediately upon that finding.
Sometimes, however, the preliminary
assessments will not provide enough
information to allow the Administrator
to decide if emissions of a substance
present a significant risk. Where that is
the case, further information will be
obtained to allow a determination to be
made. Substances for which exposures
are potentially substantial will be
assigned high priority for this further
effort.
The purposes of this "early" listing
approach are: to increase the priority of
a substance for further action, to
facilitate the expeditious application of
clearly necessary control measures to
certain sources, to accelerate the
process by which final regulatory
decisions are made, and to provide for
earlier public notice of the Agency's
views and increased public participation
in the regulatory decision-making
process. Paragraphs (a) and (b) below
describe the immediate consequences of
listing under the proposed policy.
(a) Listing Where Generic Standards
Are Applicable. As explained more fully
in a companion advance notice of
proposed rulemaking (ANPR) elsewhere
in today's Federal Register, EPA has
developed a draft set of low-cost and
readily implemented control procedures
and work practices that can be applied
to control emissions from various
categories of sources producing,
consuming, and handling significant
quantities of a broad class of substances
(volatile organic chemicals) sharing
certain properties. Where substances
listed as carcinogens under section 112
are emitted from source categories to
which these "generic standards" could
apply, the application of the standards
would be proposed immediately upon
listing.
The draft generic standards published
elsewhere in the notice as an Advance
Notice of Proposed Rulemaking (ANPR)
were developed from information and
efforts of EPA's Synthetic Organic
Chemical Manufacturing Industry
(SOCMI) standards development
program. This program was initiated in
1976 to gather technical and cost data on
the control of air pollution from organic
chemical manufacturing and to prepare
(1) new source performance standards
(NSPS) for total volatile organic
compound (VOC) emissions, (2) control
techniques guidelines (CTG) for VOC
emissions, and (3) section 112 standards
for specific volatile organic chemical
emissions.
The SOCMI program has focused its
efforts on four kinds of emissions: (1)
emissions from storage tanks and
transportation vessels, (2) fugitive leaks
and spills of VOC, (3) losses of VOC
from liquid and solid wastes, and (4)
emissions from process vents.
Information-gathering, analysis, and
standards development are at various
stages in these four areas, and the
program's goal is to develop generic
standards in each area. The draft
generic standards in today's ANPR.
dealing with leaks and spills of VOC,
represents the first generic application
of information developed by the SOCMI
program to standards under section 112.
As further information becomes
available from the program relating to
the other kinds of emissions under
study, EPA intends to develop further
generic standards for use in conjunction
with section 112. EPA would expect to
follow a public pariticpation and .
regulatory .development process similar
to that of today's ANPR in connection
with the development of additional
generic standards.
The draft generic standards which are
contained in today's ANPR would apply
to a large proportion of the organic
chemical industry, and are based on the
similarity of many operations and
equipment throughout the industry.
Examples of required procedures are the
periodic inspection for and reporting of
fugitive leaks and subsequent repair,
and the painting of storage tanks white
to reduce volatilization of organics.
Since most of the potentially
carcinogenic chemical air pollutants
identified by preliminary surveys to date
have been organic chemicals, these
generic standards would be expected to
apply to the significant sources of most
of the chemical carcinogens which might
be listed.
In general, the applicability of the
draft generic standards would be
dependent on the characteristics of
source operations and the quantity of
the substance which is produced or
handled. The application of the draft
generic standards would be proposed
only for sources dealing with significant
quantities of the listed substance, and
some "tailoring" of the standards may
be necessary for source categories of
each listed pollutant. Sources currently
meeting the requirements of such
standards would effectively be required
to continue doing so. The purpose of the
immediate proposal of the generic
standards is to ensure that risk
reduction which can quickly and easily
be achieved tfirough the implementation
of clearly appropriate "good
housekeeping" measures is not delayed
by the further assessments and detailed
analyses which will be conducted
before final regulatory decisions are
made.
These initial regulatory requirements
would not be applicable to all airborne
carcinogens, and would not necessarily
represent the degree of control which
may ultimately be required. Because the
draft generic standards currently
address only fugitive emission sources.
further standards will have to be
developed individually to control
process emissions from significant
source categories. As further generic
standards are developed for the
remaining types of emission points and
processes, the extent to which further
control requirements will have to be
V-Appendix C-8
-------
Fsd<8ir®l Eogiistor / Vol. 414. No. 197 / Wednesday, October W, W7Q / Propooed Rules
developed and applied on a case-by-
case basis will decrease significantly.
(b) Listing Where Generic Standards
Are Not Applicable While a substantial
majority of the substances which will be
listed under section 112 as airborne
carcinogens are expected to be
chemicals to which generic standards
could apply, there will be other
substances such as inorganics or
radioactive materials emitted from
source categories for which generic
standards have not been developed. In
these cases, listing of a substance will
trigger the assignment of a priority for
the development of final emission
regulations for significant categories of
sources emitting the substance.
(2) Regulation Under Section 111:
Moderate Probability of Carcinogenicity
and High Exposures
Substances for which the probability
of human carcinogenicity is moderate to
low generaltywill not be considered for
immediate regulation as carcinogens
under section 112. If analysis suggests
high exposures to a substance of
"moderate probability," however, the
resulting risk of cancer to the general
population remains of concern. Such a
substance will therefore undergo further
assessment and, unless that assessmet
indicates the substance is a high-
probability carcinogen, will be
considered for interim regulation under
section 111 of the Clean Air Act.
Under section 111, new and existing
sources may be regulated if they cause
or contribute to "air pollution which
may reasonably be anticipated to
endanger public health or welfare."
While a substance of only moderate
probability of carcinogenicity would not
generally "be reasonably anticipated to
result in an increase in mortality or an
increase in serious irreversible or
incapacitating reversible illness," high
exposures to that substance certainly
may endanger public health. Such a
substance may therefore be regulated
under section 111.
(3) Further Assessment or Testing
EPA will conduct, recommend, or
request that others conduct further
biological testing on low or moderate
probability substances. Testing may
include both cancer and other toxicity
assays with priorities based on the
extend of public exposures.
(•9) Quantitative Risk Assessments for
Listed Carcinogens
EPA will conduct a quantitative risk
assessment, if possible, for any
substance which has been listed under
section 112 as a carcinogen. While such
quantitative assessments are subject to
considerable uncertainty, the
Administrator believes that they can
provide useful information for two
phases of the proposed policy:
establishing priorities for regulation of
specific source categories of listed
pollutants, and determining the degree
of control required in final emission
standards for those source categories. In
assigning priorities for risk assessments,
consideration will be given to the
likelihood of significant exposures, the
effect of any generic standards
proposed, carcinogenic strength
(potency), and the feasibility of
expeditious control.
(a) Nature of Quantitative Risk
Assessments. Quantitative risk estimates
at ambient concentrations involve an
analysis of the effects of the substance
in high-dose epidemiological or animerU
studies, and extrapolation of these high-
dose results to relevant human exposure
routes at low doses. The mathematical
models used for such extrapolations are
based on observed dose-response
relationships for carcinogens and
assumptions about such relationships as
the dose approaches very low levels or
zero. (23), (25), (26) Examples of such
models are the linear non-threshold
model and the log probit model. (25)
Often, assumptions must be made
regarding the relevance of studies
involving doses given through feeding or
other pathways in extrapolating to
inhalation exposures. Where only
animal studies exist, additional
assumptions must be made concerning
"mouse to man" extrapolations.
The risks to public health from
emissions of a high-probability
carcinogen may be estimated by
combining the dose-response
relationship obtained from this
carcinogenicity strength calculation with
an analysis of the extent of population
exposure to the substance through the
ambient air. Exposure in this context is
a function of both the concentrator! of a
substance and the length of time the
concentration is encountered. A detailed
exposure analysis will estimate likely
exposures for long-term temporal trends,
short-term maximum levels, and
weighted averages for both the total
population exposed and subgroups
whose exposures may be significantly
greater or otherwise different from the
average.
Although ambient monitoring data
will be used whenever possible,
exposure analyses will often be based
on the use of air quality models,
available estimates of emissions from
significant source categories, and
approximationo of population
distributions near the source categories.
Similar models may be used to estimate
exposure through other pathways
ultimately resulting from air emissions.
Detailed air quality models will be used
to estimate the range of pollutant
exposures associated with each major
source category. The air quality modelo
used will generally permit estimation o?
exposures of up to 20 kilometers and
and in some cases 80 kilometers from
individual sources. Population and
growth statistics will be examined to
allow projections to be made of future
exposures. The information collected,
tegether with the existing carcinogenic
strength determinations, will be used to
provide estimates of the degree of risk to
individuals and the range of increased
cancer incidence expected from ambient
air exposures associated with source
categories of the carcinogenic air
pollutant at various possible emissions
levels.
(b) Uncertainties in the assessment of
Risk The assumptions and procedures
discussed above for extrapolation and
for exposure estimates are subject to
considerable uncertainty. Where only
animal data are available to assess the
magnitude of cancer risk to human
populations, the differences in
susceptibility between animal species
and humans, and the need to
extrapolate dose-response data to very
low ambient concentrations, result in
risk estimates that must be regarded
only as rough indications of effect. (25)
Uncertainty in exposure estimates
arises from the use of limited
monitoring, pollutant transport models,
mobility of the exposed population and
other factors. In combining these
exposure estimates with dose-response
extrapolations to provide estimates of
cancer incidence, the total uncertainties
are increased.
The primary model that EPA will use
to estimate carcinogenic risk from
exposure to a particular substance will
be the linear non-threshold dose/
response model. This model has been
chosen in order to avoid understating
the risk calculated from the
extrapolation of the effects osbserved at
high doses to the lower doses
characteristic of ambient exposure. To
the extent possible, the range of
uncertainty in the risks extrapolated
from animal studies to humans and from
high to low doses will be described.
The decision to employ estimates of
carcinogic risks despite their lack of
precision rests on the belief that
although they ere subject to
considerable uncertainties, current
analytical models and techniques can,
with due consideration of the
(uncertainties, provide useful estimates
of relative carcinogenic strength and of
V-Appendix C-9
-------
/ Vol. M, Wo. 197 / Wednesday, October 30, 1070 / Proposed Rusks
the probable genera) ranges of excess
cancer incidence and individual risks.
This view has been supported by the
National Academy of Sciences, (24) the
National Cancer Advisory Board, (27)
and others. (28)
D. Establishment and Review of
Emission Standards and Related
Requirements
(1) Introduction
A central issue in developing a policy
for the protection of public health from
carcinogens is the determination of the
extent to which exposures must be
reduced. Given the impossibility of
identifying levels of carcinogens with no
associated risk, some have argued that
no exposure should be tolerated and
that emissions should be reduced as
expeditiously as practicable to zero.
Others contend that permissible
exposures should be determined by an
unstructured balancing of risks, costs,
and benefits.
A number of approaches for
addressing the appropriate level for
control of carcinogens have been
considered or proposed by the federal
regulatory agencies, industrial groups,
environmental organizations, and
others. Prominent examples include the
OSHA proposal, the CPSC policy,0 and
the EDF petition on airborne
carcinogens. A discussion of the
suggested alternatives is presented in
the supplemental statement which
follows the text of the proposed rule.
The following sections describe the
approach proposed by EPA.
(2) The Proposed EPA Approach
The standard-setting policy proposed
today requires, as a minimum, the use of
"best available technology" (BAT) to
control emissions from source categories
presenting significant risks to public
health. The policy would also require
additional controls, es necessary, to
eliminate "unreasonable residual risks"
remaining after Hie use of best available
technology. This approach is a
judgmental one, designed to protect the
public health with an ample margin of
safety from risks associated with
exposure to airborne carcinogens. The
implementing procedure described
below puts prime emphasis on public
health, consistent with section 112, but
permits consideration of economic
impacts and benefits of the activity in
setting standards for each source
category. Uncertainties in the
assessments of rioks, costs, and
potential benefits, as well as the
distributional (equity) problems of
^The CPSC interim policy hso teej) rescinded,
-------
KogSsSsir / Vol. 44, No. 107 / Wednesday, Gctofoar HO. 2®70 / Proposed SuSeo
used by the industry to control the
pollutant of concern (technology
transfer) but which have been
demonstrated in pilot tests or other
industrial applications. Finally, the
availability and adequacy of substitutes
which would eliminate some or all
emissions of the pollutant will be
assessed.
Once the technologically feasible
control alternatives, which may range
from no further control to a complete
ban on emissions, have been identified,
the environmental, economic and energy
impacts of these options will be
determined. Considerations in these
impact assessments will include for
each option: the number of plant
closures' predicted and the direct impact
on employment and end product prices;
the impact on growth and expansion of
the industry; the resulting changes in
profitability; capital availability for
control equipment; the impacts from the
availability of substitute products and
foreign imports; the potential increases
in national energy consumption; and the
impacts on other environmental medial
including increased water pollution and
oolld waste disposal. On the basis of
these assessments, one of the control
options identified will be designated as
the "best available technology" for the
control of emissions from the sources in
the category. This level of control will
be that technology, which in the
Judgment of the Administrator, is the
most advanced level of control
adequately demonstrated, considering
economic, energy, and environmental
impacts.
The control level designated "best
available technology" may be different
(for new and existing facilities in a
category. For practical purposes, this
level of control for new sources will, as
a minimum, be equivalent to that which
would be selected as the basis for a
New Source Performance Standard
(NSPS) under section HI. The
requirement of "best available
technology" for new sources would
consider "economic feasibility" and
would not preclude new construction.
The selection of BAT for existing
sources may require consideration of the
technological problems associated with
retrofit and related differences in the
economic, energy, and environmental
impacts. In practice, BAT for existing
oources would consider economic
feasibility and would not exceed the
most advanced level of technology that
at least most members of an industry
could afford without plant closures.
(d) Minimum Requirements for
Existing Sources. Final section 112
standards will require existing sources
in any regulated source category, as a
minimum, to limit their emissions to the
levels corresponding to the USB of "best
available technology." This requirement
is based on the Administrator's'
judgment that any risks that could be
avoided through the use of these
feasible control measures are
unreasonable. Whether BAT controls
are sufficient to protect public health
will be determined by a subsequent
evaluation of the remaining risks.
(e) Determination of Unreasonable
Residual Risk for Existing Sources.
Following the identification of BAT for
existing sources, the quantitative risk
assessment described earlier will be
used to determine the risks remianing
after the application of BAT to the
source category. SI the residual risks are
not judged by the Administrator to be
unreasonable, further controls would
not be required. If, however, there is a
finding of unreasonable residual risk, a
more stringent alternative would be
required. Among the possible
alternatives would be the immediate
application of more restrictive emission
standards, including those based on
more extensive use of substitutes, and
scheduled or phased reductions
permissible emissions. The alternative
selected would be that necessary, in the
Administrator's judgment to eliminate
the unreasonable residual risks.
Given the differences in the degree of
certainty in risk estimates, in the
numbers of people exposed, in benefits,
in the distribution of risks and benefits,
in the costs of controls, in the
availability of substitutes, and in other
relevant factors, it is not possible to
state any precise formula for
determining unreasonable residual risk.
The determination will necessarily be o
matter of judgment for each category
involved. Nevertheless, the process
followed and the various factors
involved can be outlined.
The determination of unreasonable
residual risk will be based primarily on
public health, and will require
protection with an ample margin of
safety/To the extent possible,
quantitative or qualitative estimates of
various factors will be made for
purposes of comparison. Among these
are: (1) the range of total expected
cancer incidence and other health
effects in the existing and future
exposed populations through the
anticipated operating life of existing
sources; (2) the range of health risks to
the most exposed individuals; (3) readily
identifiable benefits of the substance or
activity; (4) the economic impacts of
requiring additional control measures;
(5) the distribution of the benefits of the
acitivity versus the risks it causes; and
(6) other posseible health and
environmental effects resulting from tStis
increased use of oubstituteQ.
(f) The Degree of Control Required foe
New Sources. The need to focus
independently on new oources of
carcinogenic emissions stems
principally from the nature of the threat
posed by airborne carcinogens. Because
of the lag time betweeen exposure to a
carcinogen and onset of the disease, anjr •
assessment of the magnitude of the
problem posed by current exposure
levels is subject to considerable
uncertainty, since the consequences
have not yet become manifest. Decisiono
on the appropriate level of control must
take into account the possibility that the
dimensions of the current problem have
been underestimated.
It also appears likely that the
activities causing current carcinogenic
emissions will continue to expand, and
that new ones will appear. Since new
emissions would threaten an increased
cancer incidence, it is incumbent upon
the Agency to meet that threat in
advance, especially if that can be done
free of some of the constraints
associated with the reduction of risks
from existing sources.
The policy of developing separate
requirements for new sources is based
on two additional considerations. First,
many of the factors affecting risks can
be controlled to a significant extent
before new construction takes place.
Foremost among these factors is siting: .
new sources in heavily populated areas
create much greater cancer risks than
those locating in less populated areas, fa
addition, new sources can sometimes
apply control technology more cheaply
and effectively than existing sources,
since new sources: (1) are often larger
and can thus benefit from the economieo
of scale; (2) can engineer the integration
of emission controls from the ground up;
and (3) do not have existing control
equipment which must be dismantled or
scrapped.
Second, given these differences, a
determination of the appropriate control
level for new sources on the basis of
unreasonable residual risk may also
weigh the relevant factors differently.
While the focus for existing sources is
primarily the balancing of health risks
against the costs of retrofit controls
beyond BAT, for new sources the
balance can focus more heavily on
siting, the benefits of the activity, and
the possibility of fundamental changes
in the process which would lower
emissions.
For these reasons, the Administrator
proposes to include in this policy a
mechanism dealing specifically with
mew sources. Under this mechanism,
V-Appendix C-ll
-------
f Vol. M. Wo. U97 / Wednesday, Octo&sr SO. flS78 / Proposed Kules
described in more detail below, the
standards applicable to new and
modified sources -would be risSermmed
on a caae-by-cass basis, and would •
consist of either (a) a presumptive
emission standard, (b) the best available
technology standard, or (c) an
alternative standard. Regulations
concerning procedures for the approval
of construction or modification under
esction 112 standards (
-------
/ Vol. 44, No. 197 / Wednesday, OcJobar 20. 1979 / Proposed Rules
hazards associated with the substances
examined, will indicate which
substances are receiving further
attention, and will request the
involvement of interested parties.
(b) Listing. Quantitative Risk
Assessments, and Determination of
Regulatory Priorities. The development
of regulations is a time-consuming
process. While the use of generic
standards and the initial focus on
regulating the most significant sources
first will accelerate the process of
reducing risks to public health, it is
likely that regulation of medium and
lower priority sources will not be
completed for a number of years. To
insure that the public, industry, and the
states are aware of the status of federal
regulatory efforts, the results of risk
assessments and priority determinations
will be published in the Federal
Register. These notices will include
decisions and recommended actions on
all substances under review.
(c) Proposal and Promulgation of
Standards. Upon the proposal of generic
or final regulations for source categories
of listed airborne carcinogens, EPA will
hold public hearings^and solicit written
comments on the proposed rulemaking.
Records of such hearings and comments
received will be made available for
public inspection through the
maintenance of public dockets.
(5) Preparation of Regulatory Analyses
This proposal is classified as a major
regulation under EPA's final report
implementing Executive Order 12044
"Improving Government Regulations"
(44 FR 30988) in that it addresses a
"major health or ecological problem."
The Executive Order requires that a
regulatory analysis of potential
economic impacts be prepared for major
regulations meeting certain criteria. The
criteria are, in brief: 1) additional costs
of compliance totalling $100 million; 2)
additional costs of production exceeding
5 percent of the selling price of the
product; or 3) the Administrator requests
such an analysis.
The procedures outlined in the
proposed rule are intended to guide the
Agency in the identification and control
of airborne carcinogens under the
principal authority of section 112 of the
Clean Air Act. The policy does not
impose regulatory requirements on any
emission source and, therefore, does not
meet either of the economic criteria for
preparing a regulatory analysis. The
purpose of the policy is to establish a
framework for EPA decisions including
the conduct of economic and risk
analyses of subsequent regulatory
actions. To attempt to quantify the
impact of future regulations requiring
unidentified controls on unknown
source categories of, as yet unnamed
pollutants would not, in the judgment of
the Administrator, be a meaningful
exercise.
While an economic analysis is not
considered appropriate for this proposed
procedural rule, EPA has considered
possible regulatory alternatives. A
discussion of relevant issues is
presented in the supplemental statement
of basis and purpose which follows the
text of the proposed rule.
(6) Periodic Review
At intervals of no more than five
years, regulations promulgated for each
source category of airborne carcinogens
will be reviewed for possible
modification, based on recent
technological developments and any
new health effects information
available. This will provide an
opportunity to consider the tightening of
standards for existing sources to reflect
new technology, and the application of
innovative technologies for new sources.
At the conclusion of each review,
standards will be revised to reflect more
stringent control requirements, or the
existing standards may be reaffirmed, as
appropriate.
(Sections 111, 112, and 30l(a) of the Clean Air
Act. as amended, 42 U.S.C. sections 7411,
7412, and 7601 (a).)
Dated: August 22,1979.
Douglas H. Costle,
Administrator.
The Administrator proposes to add
the following rule as Appendix C to Part
61 of Title 40 of the Code of Federal
Regulations:
Appendix C—Policy and Procedures fe
Identifying, Assessing, and Regulating
Airborne Substances Poatag a Riots, of Canes;
I. Introduction
A. Scope of Rule
This rule specifies the policies used by EPA
in the regulation of stationary sources of
potentially carcinogenic air pollutants under
relevant Clean Air Act authorities,
principally section 112. The rule does not
' affect regulation of non-carcinogenic
hazardous substances under section 112'°or
supplemental regulation of airborne
carcinogens under other Agency authorities
where applicable.
B. Statement of General Policy
(1) The EPA policy for regulation of sources
emitting airborne carcinogens under section
112 of the Clean Air Act is to protect the
10 A substance may also be regulated under
section 112 due to its non-carcinogenic health
effects, or due to a combination of carcinogenic and
other serious effects. Non-carcinogenic effects of
substances being reviewed as possible airborne
carcinogens will also be evaluated and considered
where information on theoe effects io available.
public health with an ample margin of safety.
This protection Will be achieved by requiring
the elimination of unreasonable residual rioka
from existing oourceo as quickly eg poooibh,
and by preventing the development of such
risks from new sources. •
(2) The presence of "unreasonable residual
risks" to an affected population will be
determined independently for each category
of sources regulated. Primary emphasis in
this determination will be on the level of Hah
remaining after the installation of the "beot
available technology" for the control of
emissions from sources in the category. In
evaluating this risk, consideration will be
given to the benefits conferred by the
substance or activity, the distribution of
those benefits versus the distribution of the
risks presented by the substance or activity,
the availability of substitutes, the cost of
further control of the substance or source
category, and the proposed siting of new
sources.
51. Preliminary Assessment of Health Risks
A. Identification of Candidate Substances
Potential airborne carcinogens (candidate
substances) will be identified through EPA
programs, including searches of the scientific
literature, monitoring studies, and biological
assays of substances found in the ambient air
and source emissions, as well as by
examining information obtained from federal.
state, or other public testing or regulatory
authorites. private research groups, and other
scientific sources.
B. Screening
Candidate substances will be screened to
determine the potential extent of exposure of
the public through air emissions.
(1) Screening of candidate substances will
consist of an analysis of readily available
information on their production, uses,
properties, air concentrations, and of other
indices useful in assessing the potential for
public exposure. EPA will also ascertain
whether any other regulatory efforts are in
progress with respect to these substances.
(2) Substances which the identification and
screening process indicates (a) may be
carcinogenic and (b) the public probably is
exposed to via the ambient air will be
evaluated to determine whether they pose a
significant carcinogenic risk to the public.
Substances with the greatest apparent
potential for public exposure will be given
highest priority for this further examination.
C. Preliminary Evaluation of Risk
The preliminary evaluation of the risks
posed by a candidate substance will consist
primarily of an evaluation of the probability
that it is a human carcinogen and a
preliminary evaluation of the extent of
ambient exposure.
(1) Evaluation of the Probability of Human
Corcinogenicity. Evaluation of the probability
that a substance is a human carcinogen will
be performed using criteria adopted by EPA
for such determinations. These currently
applicable criteria are summarized in the
Interim Guidelines for Carcinogen Risk
Assessment (41 FR 21404; May 25.1976).
Using these criteria, the weight and quality of
evidence of human carcinogenicity for
V-Appendix C-13
-------
/ Vol. «4. No. 107 / Wednesday, Octobsr 10, 1879 / Proposed Rules
candidate substances will be assessed. Based
on such assessments, including comparison
with other substances which have been
evaluated for regulatory action, a judgment of
the probability that a substance is a human,
carcinogen for regulertory purposes will be
made roughly as follows:
(a) High Probability of Human
Carcinogenicity—Substances for which
"best" or "substantial" evidence exists from
epidemiological and/or at least one
mammalian study.
(b) Moderate Probability of Human
Carcinogenicity—Substances for which
"ouggestive" evidence exists from
epidemiological. animal, or "short-term"
otudies.
(c) Low Probability of Human
Carcinogenicity—Substances for which only
"ancillary" evidence exists, such as from
structural correlations, or for which
epidemiological or animal results are judged
to indicate low probability.
(2) Preliminary Evaluation of Ambient
Exposure. EPA will also conduct preliminary
evaluations to determine whether source
emissions of high-probability carcinogens
exist which cause or contribute to air
pollution posing significant carcinogenic risks
to the public. Among the factors that this
evaluation may take into account are the
number and types of Bourses emitting the
substances in areas where people may be
exposed, the volume of their emissions, any
ambient concentrations which may have
been reported, and the number of people
living near emitting sources or in the vicinity
of ambient measurement sites. Where
available, estimates of carcinogenic strength
may be used to compute preliminary
quantitative estimates of lifetime individual
risks to the potentially most exposed
individuals.
III. Initial Responses to Preliminary
Assessment of Health Risks
A. Listing
Substances judged by the Administrator to
present significant carcinogenic risks to the
public will be listed under section 112 as
hazardous air pollutants. A substance will be
Judged to present a significant carcinogenic
risk if (1) it is judged by the Administrator to
have a high probability of being a human
carcinogen, and (2) there is evidence of
significant public exposure via the ambient
air from emissions from one or more
categories of stationary sources. Where the
available evidence is otherwise insufficient
to indicate the existence of a significant risk,
a high-probability carcinogen also will be
Holed under section 112 if a preliminary
quantitative risk estimate suggests that a
significant risk to the potentially most
exposed groups exists. Where emissions or
exposure data indicate the existence of a
significant risk, quantitative risk estimates
will not be considered evidence to the
contrary.
B. Generic Standards
Upon the listing of a substance, previously-
developed generic standards will be
proposed for source categories of that
substance to which they could apply. Generic
standards, developed based on the
oimilarities.among industrial processes, will
be "tailored" as necessary to fit the source
categories for which they are proposed.
C. Moderate-Probability and Low-Probability
Carcinogens
EPA will recommend or require further
biological testing of substances initially
judged to have a moderate or low-probability
of being human carcinogens. Priorities for
testing will be based on the extent of public
exposure. Moderate-probability substances
for which public exposures appear to be high
will be considered for regulation under
section 111 of the Clean Air Act.
D. Quantitative Risk Assessments
Quantitative risk assessments on all high-
probability carcinogens will be performed, if
possible. These assessments will be
undertaken based on priorities designed to
produce action most quickly on the most
serious problems pending at_any given time.
The results of these assessments will be used
in the assignment of priorities for further
regulation and in the evaluation of residual
risks.
(1) The risk assessments will examine:
(a) detailed information on emission
sources of the pollutants, the sources' control
status and total emissions, measured and
predicted ambient concentrations of the
pollutants, and the production levels and
uses of the substances;
(b) distribution of the population around
sources in specific sources categories;
(c) estimated duration and magnitude of
exposures of the affected population and the
most exposed individuals;
(d) estimated carcinogenic strength
(potency) of the substances;
(e) estimated range of expected cancer
incidence for the total population and
individual risks for the most exposed
individuals at various possible emission
levels:
(f) other serious health effects of the
substances; and
(g) projected population growth around
existing sources.
(2) The criteria to be considered in
assigning priorities for quantitative risk
assessments include, in usual order of
importance:
(a) probable extent of exposure of the
public through air emissions;
(b) estimated carcinogenic strength;
(c) the effect of any generic standards
proposed; and
(d) the feasibility of expeditious control.
(3) The results of detailed risk assessments
and determinations resulting from the
assessments will be published in the Federal
Register and public comments will be
solicited.
IV. Eslabliohmsn! and Review of Standards
A. Source Categories Regulated
Emission standards in addition to generic
standards will be proposed for any source
category whose emissions present a
significant risk to public health. Such
standards and other requirements will be
determined independently for each regulated
source category. A source category emitting a
listed pollutant will be found to pose a
significant risk if there is evidence, from the
detailed exposure analysis, that its emissions
result in significant public exposure to the
pollutant via the ambient air. Significant risk
also will be found in the absence of such
evidence, if a detailed risk assessment
suggests that such a risk to the most exposed
individuals or to the population exists. If
emissions or exposure data indicate the
existence of a significant risk, the
quantitative risk assessment will not be
considered as evidence to the contrary.
B. Priorities for Further Regulation
Further standards and requirements for
regulated source categories will be developed
according to the priority assigned to those
source categories. Source, categories will be
assigned high, medium, or low priority based
on the following criteria:
(1) magnitude of the total expected and
upper bound cancer incidence associated
with exposure to all carcinogens emitted by
the source category:
(2) degree of risk to the most exposed
individuals;
(3) ease of expeditious development and
implementation of standards; and
(4) feasibility of significant improvements
in controls.
C. Regulatory Options Analysis
EPA will conduct a regulatory options
analysis to support decisions on further
required control measures.
(1) The analysis will identify
technologically feasible control alternatives.
their economic, energy, and environmental
impacts, and, in the case of substitutes, the
benefits of continued use of the substance or
process.
(2) The analysis will also designate levels
of control considered "best available
technology" for new and for existing sources
in a category. The control level designated
"best available technology" may be different
for new and existing facilities in a category.
(a) For new sources, "best available
technology" is that technology which, in the
judgment of the Administrator, is the most
advanced level of controls adequately
demonstrated, considering economic, energy,
and environmental impacts.
(b) For existing sources, "best available
technology" is that technology which, in the
judgment of the Administrator, is the most
advanced level of controls adequately
demonstrated, considering economic, energy,
environmental impacts, and the technological
problems associated with retrofit.
D. Requirements for Existing Sources
(1) Existing sources in a regulated source
category will be required, as a minimum, to
limit their emissions to the levels
corresponding to the use of "best available
technology".
(2) Existing sources in a regulated source
category also will be required to limit their
emissions in whatever additional amount is
necessary, in the Administrator's judgment,
to eliminate unreasonable residual risks to
public health associated with those
emissions.
(3) The principal emphasis in determining
the level of additional control required to
V-Appendix C-14
-------
/ Vol. 44, No. 197 / Wednesday. October 10, 1979 / Proposed Rules
eliminate unreasonable residual risk from an
existing source category will be on public
health. Factors which may be considered in
this judgment include:
(a) the range of total expected cancer
incidence and other serious health effects in
the existing and future populations exposed,
for the anticipated operating life of existing
sources in the category:
(b) the range of health risks to the most
exposed individuals;
(c) readily identifiable benefits of the
substance or activity producing the risk;
(d) the economic effects (expecially plant
closures) of requiring additional control
measures;
(e) the distribution of the benefits of the
activity versus the distribution of its risks;
and
(f) other possible health effects resulting
from the increased use of substitutes.
E. Requirements for New (Including
Modified) Sources
(1) Except as provided below, new sources
in a regulated source category will be
required to meet a presumptive national
emission standard designed to preclude the
existence of significant risks under projected
worst case assumptions of plant size and
emissions, surrounding population density
and distribution, and meteorology.
(2) Any proposed new source which shows,
in the certification process required by
section 112(c)(l)(A). that it meets the
requirements of the Risk Avoidance Criteria
(described below) applicable to that source
category will automatically be permitted to
meet the applicable best available technology
standard instead of the applicable
presumptive national emission standard. The
specific terms of Risk Avoidance Criteria will
be prescribed separately for each source
category.
The criteria will generally require that
either:
(a)(l) Population density and distribution
around the proposed site at the source's
proposed emission rate are within limits
specified by EPA, and
(2) The proposed source is not within a
specified distance of a source of carcinogens
regulated under section 112; or
(b) An offset against new emissions can be
obtained either internally (existing sources
seeking to expand) or from existing sources
of carcinogens regulated under section 112
within a specified distance,
(3) Any proposed new source which is
unable to qualify for the automatic waiver to
best available technology described in
paragraph (2) may apply for the
establishment of an alternative standard
applicable to the proposed source as part of
the certification process required under
section 112(c)(l)(A). The Administrator will
establish an alternative standard for that
source at the best available technology
standard or at whatever more stringent level
of control is necessary, in his/her judgment,
to prevent the existence of an unreasonable
residual risk associated with emissions from
the proposed source. Factors which may be
considered in this judgment include:
(a) the range of total expected cancer
incidence and other serious health effects
associated with emissions of the source
throughout its anticipated operating life;
(b) the range of health risks to the most
exposed individuals from the source's
emissions;
(c) existing risks to the affected population
from emissions of the listed pollutant and
other carcinogenic air pollutants;
(d) readily identifiable benefits of the
substance or the activity producing the risk;
(e) the economic and technological
feasibility of control measures more stringent
than BAT;
(f) the distribution of the benefits of the
activity versus the distribution of its risks;
(g) other possible health effects resulting
from the use of substitutes for the substance
or activity; and
(h) the extent to which possible emission
offsets have been obtained.
F. Review of Standards and Requirements
Regulations promulgated for each source
category of airborne carcinogens will be
reviewed and, if appropriate, revised at
intervals of no more than five years.
Refersncao
1. Pellizzari. E. D., "Development of
Methods for Carcinogenic Vapor Analysis in
Ambient Atmospheres". Publication No.
EPA-605/2-74-121, RTP, N.C. July 1974.
2. Pitts, J., D. Grosjean and T. M. Mischke,
Mutagenic Activity of Airborne Particulate
Organic Pollutants, Toxicology Letters, 1:65-
70 (1977).
3. Sawicki, E., "Chemical Composition and
Potential Genotoxic Aspects of Polluted
Atmospheres". Mohr, U., Tomatis, L., and
Schmahl, D., eds, in Air Pollution and Cancer
in Man, International Agency for Research on
Cancer (1ARC Scientific Publication No. 16).
Lyon, Franke (1977).
<3. Occupational Safety and Health
Administration, "Identification, Classification
and Regulation of Toxic Substances Posing a
Potential Occupational Carcinogenic Risk",
29 CFR Part 1SSO, 43 FR 54148, October 4,
1977.
5. Consumer Product Safety Commission,
"Interim Policy and Procedure for Classifying,
Evaluating, and Regulating Carcinogens in
Consumer Products", 43 FR 25658, June 13,
1978 (withdrawn April 23,1979 44 FR 23821).
6. "Carcinogens in the Environment", in:
Council on Environmental Quality, Sixth
Annual Report, Washington, D.C. (1975).
7. Caims, J., "The Cancer Problem",
Scientific American, 233(5):64-78, (November
1975).
8. Young,}. L., A. J. Asire, and E. S. Pollack,
"SEER Program: Cancer Incidence and
Mortality in the United States 1973-1978",
DHEW Publication No. (NIH) 78-1837,
National Cancer Institute, Bethesda,
Maryland (1978).
9. "Prevention of Cancer", Report of a
World Health Organization Expert
Committee, WHO Technical Report Series
No. 278, Geneva, 1984.
10. Fraumeni, J. E., Ed., Persons at High
Risk of Cancer An Approach to Cancer
Etiology and Control. Academic Press. Inc.,
New York (1975).
11. Selikofif, Irving J. tn Persons at High
Risk of Cancer An Approach to Cancer
Etiology and Control. Academic Press. Inc.,
New York (1975).
12. Maugh, J. H.. "Chemical Carcinogens:
The Scientific Basis for Regulation", Science
201:12CO-1205. September 29,1975.
13. Mohr. V., L. Tomatis, P. Schmahl, Air
Pollution and Cancer in Man, pp. 169-253.
International for Research on Cancer.
Publication No. 16, Lyon, France (1977).
14. Cederloff, R., R. Doll, B. Foyer, L
Friberg, N. Nelson, and V. VouJt (ed), "Air.
Pollution and Cancer: Risk Assessment
Methodology and Epidemiologies! Evidence".
Environmental Health Perspectives. 22:1-12,
February 1978.
15. Pike, M. C. et al. "Air Pollution" in
Persons at High Risk of Cancer An
Approach to Cancer Etiology and Control.
Academic Press, Inc., New York (1975).
16. "Cancer Facts and Figures", American
Cancer Society, New York (1974).
17. "Estimates of the Fraction of Cancer
Incidence in the United States Attributable to
Occupational Factors", National Institute of
Environmental Health Sciences, Draft
Summary, September 11,1978.
18. "Preliminary Scoring of Organic Air
Pollutants", EPA-«50/3-77-G08 (1976).
19. Faoro, Robert B. and J. A. Manning,
'Trends in Benzo(a)pyrene (1986-1975)", pre-
publication 1978 copy, accepted for
publication in JAPCA.
20. Atmospheric Benzene Emissions, U.S.
EPA, RTP, N.C. October, 1977 (EPA-450/3-
88-029).
21. National Emission Standards for
Hazardous Air Pollutants. Asbestos,
Beryllium, and Mecury, EPA, 38 FR 8820
(1973).
22. National Emission Standards for
Hazardous Air Pollutants, Proposed Standard
for Vinyl Cloride. EPA. 40 FR 59532,
December 24,1975 (final standard 41 FR
46560).
23. Maugh, T. H.. "Chemical Carcinogens:
How Dangerous are Low Doses?" Science
202: 37-41, October 8,1978.
24. Drinking Water and Health, Part 1,
Chapters 1-5, Draft, National Research
Council, National Academy of Sciences,
Washington, D.C. (1977).
25. EPA, "Health Risk and Economic
Impact Assessments for Suspected
Carcinogens", Interim Procedures and
Guidelines, 41 FR 24102. May 25,1976.
26. "Scientific Bases for Identification of
Potential Carcinogens and Estimation of
Risks" Report by the Work Group on Risk
Assessment of the Interagency Regulatory
Liaison Group (IRGL) 44 FR 39858, July 6.
1979.
27. "General Criteria for Assessing the
Evidence for Carcinogenicity of Chemical
Substances," Report of the Subcommittee on
Environmental Carcinogenesis, National
Cancer Advisory Board, Journal of the
National Cancer Institute, 58:2, February,
1977.
28. Hoel, David G.. et al. "Estimation of
Risks of Irreversible, Delayed Toxicity."
Journal of Toxicology and Environmental
Health 1:133-151,1975.
29. Bachmann. John D. and John R.
O'Connor, "Identification, Assessment, and
Regulation of Toxic Air Pollutants" presented
at the Air Pollution Control Association
V-Appendix C-15
-------
Kogisioir / Vol. €4, No. 187 / Wednesday, October 10. 1079 / Proposed IRulss
Speciality Conference, February 14,1979.
Gainesville, Florida.
30. "Petition for the Initiation of
Rulemaking Proceedings to Establish a Policy
Governing the Classification and Regulation
of Carcinogenic Air Pollutants under the
Clean Air Act," Environmental Defense Fund,
November 7,1977.
31. "Public Meeting—Regulation of
Carcinogenic Air Pollutants," EPA Internal
Memorandum from Joseph Padgett to Walter
C. Barber, May 17.1978.
32. "Summary of Responses and
Proposals—Testimony and Written
Submissions," U.S. EPA Public Hearings on
Regulation of Carcinogenic Air Pollutants,
Washington, D.C., March 23,1978.
33. "Testimony on OSHA's Generic
Carcinogen Proposal," American Industrial
Health Council, New York, May 16,197B.
34. "Quantitative Risk Assessment for
Ambient Exposure to Arsenic," U.S. EPA
Carcinogen Assessment Group, November 27,
1978.
35. "Smoking and Health: A Report of the
Surgeon General" Public Health Service. U.S.
DHEW, January, 1979.
36.1. J. Selikoff. E. C. Hammond, and J.
Churg "Asbestos exposure, smoking, and
neoplasia" JAMA 204(2): 108, April 8,1888.
37. "Asbestos Exposure, Cigarette Smoking,
and Death Rates" E. C. Hammond, I. J.
Selikoff. and H. Seidman. Presented at the °
International Conference on Health Hazards
of Asbestos Exposure, New York Academy of
Sciences, June 24,1978.
[Note.—This Supplemental Statement will
not appear in the Code of Federal
{Regulations.]
Policy and Procedures for Identifying,
Substances Posing a Hick of Cancer
Supplemental Statement of Basis and
Purpose
This document is intended as an
elaboration of three aspects of the basic and
purpose of EPA's proposed rule for the
regulation of airborne carcinogens. It should
be read in conjunction with the preamble to
the Notice of Proposed Rulemaking for this
action, which it supplements. The three
aspects of the background of the proposal
which are discussed in this supplement are:
(1) a comparison of the EPA proposal with
recent proposals of other Federal agencies for
regulating carcinogens: (2) various regulatory
approaches considered by the Administrator
in formulating the proposed rule; and (3) a
fuller explanation of the underlying view of
the meaning and intent of section 112 of the
Clean Air Act which led the Administrator to
choose the standard-setting approach
actually proposed.
The policies and regulatory approaches
reflected in EPA's proposed rule are similar
in many important respects to those
contained in recent proposals by the
Occupational Safety and Health
Administration (OSHA) [1] and the Consumer
Product Safety Commission (CPSC) (2). There
eire also a number of similarities to proposals
made to EPA and other agencies by the
Environmental Defense Fund (EDF) (3) and to
Borne extent by the American Industrial
Health Council (AIHC) (
-------
IFsdora! EogisteF / Vol. 44, No. 197 / Wednesday, October 10. 1979 / Proposed Rules
scientific and policy judgments in evaluating
test results.
C. Response to Determinations of
Carcinogen/city
Under the policy proposed by OSHA (upon
which the EOF petition is modeled).
oubstances classified as "confirmed
carcinogens" would be automatically
regulated through an immediate emergency
temporary standard including exposure
limits, monitoring, and work practices.
Within six months, a permanent standard
would be proposed to: (1) effectively ban the
oubstance if a suitable substitute were
available and (2) require exposures to be
reduced to lowest feasible level through
technological means.
The approach published by the CPSC
eotablishes procedures for identification and
classification of carcinogens based on
ocientific criteria and categories similar to
those proposed by OSHA. A major difference
between the CPSC and OSHA approaches is
that if a substance is identified as a
confirmed carcinogen ("Category A"), CPSC
would not automatically propose a particular
regulatory action. Instead action would be
taken on a case-by-case basis, after a study
of relevant factors.
EPA believes that the appropriate
regulatory response following the listing of an
airborne carcinogen under section 112 must
take into consideration more than a
determination of carcinogenicity. Given the
large number of potential airborne
carcinogens, some means of establishing
priorities for regulating those substances
posing the greatest public health risks is
necessary to ensure that available Agency
resources are used to -the greatest effect. The
set of initial regulatory responses in the
proposed EPA rule is designed to accomplish
that by accelerating the process of listing and
initial regulation, and by enabling the Agency
to address the most significant sources and
substances first.
The CPSC policy also recognizes the need
for such procedures. The system for setting
priorities for assessment proposed by EPA is
conceptually similar to that adopted by CPSC
for establishing priorities for staff evaluation
and Commission appraisal of consumer
products containing carcinogens.
The OSHA and EOF proposals do not
contain explicit procedures for the
establishment of priorities after
carcinogenicity determinations. Those
proposals would entail a fairly rigid schedule
of regulatory responses to notification or
discovery of potential carcinogenicity. After
carcinogenicity determinations, both the
OSHA and EOF schemes would require
automatic responses without explicit
consideration of risks or other indices of
relative priority.
One element of the OSHA proposal is the
immediate imposition of an emergency
temporary standard. The response is
somewhat analogous to the "generic
standards" element of today's proposal. Like
OSHA. EPA believes that there is no reason
to permit the continued exposure to risks
which could be prevented by the use of
clearly feasible control measures. EPA views
the implementation of such measures as a
high priority matter, especially since the
application of pre-existing generic standards
to specific sources will not divert significant
Agency resources from other control efforts.
EPA also believes, however, that a system
for establishing priorities for further
regulatory actions is necessary in effectively
implementing section 112. The Agency does
not believe that a full system of automatic
responses, such as that proposed by OSHA,
would be feasible for use under section 112,
both because of the large number of airborne
carcinogens likely to be encountered and
because of the differences in the statutory
and practical tasks EPA must perform.
D. Role of Quantitative Risk Assessment
It is not celar what role, if any, quantitative
risk estimates would play in the approach
OSHA intends to employ. As noted earlier,
EPA believes that, while cancer risk
estimation is an imprecise endeavor
involving many uncertainties, such estimation
can provide a rough measure of the
magnitude of carcinogenic risk posed by a
substance. EPA believes that consideration of
such estimates in establishing regulatory
priorities and in determining the degree of
additional control required beyond BAT is
both useful and appropriate under section
112. This is particularly true in the
Administrator's view with respect to
exposures to carcinogens in the ambient
environment, which, in contrast to
occupational exposures, can often be very
low and involve large populations. Like
OSHA, however, EPA does not view these
estimates as required for the decision that a
particular substance being emitted into the
air should be regulated as a hazardous
pollutant, once a determination of probable
carcinogenicity and significant exposure has
been made.
US. Various Regulatory Approaches
Considered
A central issue in developing a policy for
the protection of public health from
carcinogens is the determination of the extent
to which exposures must be reduced. Given
the impossibility of identifying levels of
carcinogens with no associated risk, some
have argued that no exposure should be
tolerated and that emissions should be
reduced as expeditiously as practical to zero.
Others contend, on the contrary, that
permissible exposures should be determined
by an unstructured balancing of risks, costs,
and benefits.
A number of approaches for addressing
this problem have been considered or
proposed by the Federal regulatory agencies,
industioal groups, environmental
organizations, and others. Prominent
examples include the OSHA proposal 1, the
CPSC policy (2), and the EOF petition (3) on
airborne carcinogens. This section discusses
various suggested possibilities that have been
considered by EPA, as well as the approach
proposed today.
The possibile approaches and schemes
suggested fall into essentially four groups:
zero-oriented approaches; predetermined
decision rules: special approaches for new
sources; and judgmental approaches. The
charcteristica of these approaches are
discussed below in terms of their possible
usefulness in regulating carcinogens under
section 112 of the Clean Air Act.
A. Zero-Oriented Approaches
As discussed above, the lack of identifiable
health effects exposure thresholds for
carcinogens suggests that exposure to even
minute amounts of such oubstances poses
some finite risk, and that repeated exposureo
increase the risk. This has led to the
proposition that for public health purposes,
no level of exposure to carcinogens can be
considered absolutely "safe." In particular,
because section 112 emission standards muot
protect the public health with an ample
margin of safety, it has been argued that
those standards must therefore eliminate risk
completely.
The Administrator believes that his goal in
administering section 112 must be to reduce
exposures to carcinogens to the maximum
extent possible. While this implies at least a
theoretical goal of zero emissions of these
oubstances. the immediate imposition of zero-
emission requirements would lead to the
closing of most facilities now emitting
carcinogenic air pollutants. It is not now
physically possible, for example, to
manufacture, handle, and store volatile
organic compounds without some emissions,
however small.
As noted earlier, the Administrator does
not believe that the immediate imposition of
zero-emission standards on a general basis,
with their attendant consequences, is
appropriate under section 112. Nevertheless,
in setting section 112 emission standards,
public health considerations must be
paramount. Various mechanisms designed to
minimize risk as part of certain zero-oriented
approaches may therefore be useful for
purposes of section 112. These mechanisms
include:
(1) Immediate Emission Control
Requirements Beyond the use of Best
Available Technology. Standards more
restrictive than those achievable through the
use of "best available technology" for
existing sources, effective within between
ninety days and two years of promulgation,
could result in the closure of some sources."
Depending on the degree of additional control
judged necessary, and on particular economic
and technological factors, this could range
from a few older, marginal facilities to
industry closure. Such requirement may be
appropriate where large residual risks remain
after the use of best available controls.
(2) Phased Control Requirements. Although
standards requiring controls beyond "best
available" might not be immediately feasible
for certain affected emission sources, such
controls might be feasible if sufficient lead
time were available before their required
achievement. A form of phased control
requirements, designed to force technology
improvements, is suggested by EOF in its
petition. This approach would involve
establishing a predetermined schedule for
periodic tightening of emission standards.
leading ultimately to zero emissions. EPA
11 The meaning of the term "best available
technology" as uoed here, ig explained in the
principal text accompanying the proponed rule.
V-Appendix C-17
-------
isJar / Vol. «4, Mo. W7 j Wedneoday. ©cteberlp, • W9 /
does not regard this particular form of phased
control as well-suited for use under section
112. primarily because it fails to provide for
consideration of the consequences of a zero-
emissions requirement in differing
circumstances, and because it could prove
legally and practically infeaslble for the
Agency to implement.
The concept of technology forcing phased
control has, however, been used in achieving
ambient air standards and reducing
automotive emissions, and may be employed
on a more selective basis under the proposed
rule. Such requirements might entail
somewhat accelerated closure of older,
poorly controlled plants, allowing time for
funding and construction of better controlled
facilities and the development of improved
control technology. This approach could
result in reduction of risks without extensive
economic dislocation or loss of the benefits
associated with the activity or substance
involved.
(3) Required Vse of Substitutes. The
availability of safe and adequate substitutes
for particular substances or uses can be an
important factor in determining the degree of
control required for a given source category.
It has been suggested, in fact, that in order to
eliminate emissions of the carcinogenic
substance the use of substitutes should be
required whenever they exist.
The main difficulty with this approach is
that while partial or full substitutes are often
available, their consequences vary greatly. In
many cases, for example, requiring the use of
substitutes can result in prohibitive economic
penalties. Substitutes available for come
applications are also often inadequate for
other applications.-Moreover, the potential
Stealth effects associated with substitutes will
often be unknown. Since adequate
substitutes are often similar to the origmial
substances, they may therefore pose risks
which could approach or exceed those of the
banned substances.
In addition, because carcinogens can be
emitted in varying amounts from such diverse
oources as fireplaces, chemical plants.
automobiles, dry cleaning establishments.
oteel manufacturing, and natural chemical
end radioactive emission sources elimination
of carcinogenic risks through substitution for
all these activities is clearly impractical.
Substitutes cannot therefore be realistically
considered a solution for all or even most
airborne carcinogen problems.
in establishing control requirements under
section 112, consequently, EPA would
consider measures requiring the use of
substitutes. In reaching a decision, however,
the Agency will also weigh the factors noted
above to ensure that the net effect of such
requirements is consistent with the other
aspects of the proposed rule.
B. Predetermined Decision Rules
A number of approaches, rejecting the zero
risk concept, suggest that the appropriate
degree of control can be determined through
uniform decision rules, applied irrespective of
individual circumstances. While such
decision rules vary widely in their relative
emphasis on factors such as risk, cost,
benefits, and technology, they share the
central premise that regulatory consistency
can b« achieved % prescribing in advance
the weight to be assigned to'saoh of theoe
factors under oil circumstances.
Although regulatory consistency is
desirable, decisions made according to
predetermined rules ore often unable to
account adequately 'for unforeseen or varying
circumstances. Because of-She difficulty in
anticipating all possible combinations of the
relevant factora decisions bound by such
rules will frequently fell to produce desirable
regulatory results.
EPA feels that while 4Us important to
articulate the raey in which relevant factors
will be considered and weighed in
determining control requirements for airborne
carcinogens, the complexity and
unpredictability of the situations that may
arise dictate that come flexibility be .
maintained. Predetermined decision rules will
therefore not form the principal basis for
determining control requirements for airborne
carcinogens under osctron 112. Nevertheless,
some elements of decision rule approaches
may be useful as benchmarks or guidelines.
These approache^ara-diocuBcsd below.
(1) Specification ofaHsted Target
Carcinogenic Risk orlneidonce Level. This
approach involves the celecthm of a target
level of cancer risk or incidence for purposes
of regulatory action, and is based on the use
of quantitative rick assessment techniques.
Under this approach, a fixed numerical rick
or expected cancer incidence rate target
would be used in ctetennining the degree of
control required for carcinogens.
The use of target rick levels-does iiave
some precedent as a basis for regulatory
decisions. The FDA, for essraple, has
regarded an upper bound lifetime cancer
incidence rate efiaca'Jfean-oaeper million'
people expocad to CEraino^snic residues in
certain foods as "virtually safe". EPAtxruld
theoretically establish a similar goal for
airborne carcinogens for use under section
112. If the predicted risk or incidence were
higher than the target.'the degree of control
required trculd'bethxit needed to reach the
goal.
While this approach might be consistent
with the requirement that oection 112
standards place primary emphasis on
protection of public health, it suffers from
two drawbacks. First, although current
quantitative rick assessment techniques for
chemical carcinogens are useful
decisionmaking tools, considerable
uncertainties are associated with the
techniques at their current stage of
development. Consequently, the
Administrator believes that in using
quantitative risk assessments, he should
generally be free to consider the varying
degrees of uncertainty that actual cancer
risks may be significantly above or below
those predicted by the estimation procedures,
and not be bound by a fixed target.
Second, a fixed target risk level, used as
the determinant of emissions standards,
would also inadequately account for the
varying conditions characteristic of air
pollution. The suggested use of target risk
levels instead of a zero-risk requirement is
based on the importance of considering the
various consequences of incremental riak
reductions to lewalo apptreactjing SCTO, and it
raould be inoonaicteit c/itJi &is basis to.tiae Q
fixed target risk level, irrespective of these
varying consequences, in setting standards.
These consequences differ greatly among
source categories of air pollutants, and a
freed target fails-to provide She flexibility
necessary for an appropriate response.
Where risks could be-reduced beyond the
target without significant ccato, for example,
that should be permitted. Likewios, cohere
attainment of the goal wcru'.d eliminate a
highly beneficial activity.'the decision-maker
should be able to ccnoidor less otringent
standards.
(2) "Cost-Par-Life" Goals. Some have
suggested that "acceptable" •standards for
carcinogens may be developed by striking Q
predetermined balance of health risks, human
lives, economics, and oociel benefits.
Fundamental to this approach .io the
expression of all these factors in economic
terms and the adoption of a cost-per-life-
oaved goal. Under this decision rule scheme,
regulations would require control to, but not
beyond, tbe point where the incremental
costs associated with caving an additional
life were equivalent to the goal. Proponents
of this approach argue that it would result in
Q more optimal allocation of national
resources.
The Administrator believes that several
aspectsOf this approach rsffirisr it unsuitable
for standard-Getting tmder section 112. One
such a spec! is the basic Qooumption that it is
appropriate to araign a single monetary value
to human life. The Administrator regards that
task aa neither practical nor ethically
acceptable, it is impractical because no
consensus criteria exist which can Jbs need to
establish that cost value, indeed, the
internalized and external expenditures for
protection of .human lives in American
oociety ranges across a traot opsctnim, and
.the very existence of this opectnim is
pCTOUEsive evidence that the oociety places
heavy emphaaio on the ouivounding
circumstances in "assigning" health
protection values. The approach io also
unacceptable in thsNt Jallo to.consider the
balance of equities between those benefiting
from the activity creating'the'risk and those
e»ho may die oo Q concsqueacs of the
activity. Finally, the lined-coot approach aioo
necessarily ascribes more csrtointy to the
risk assessment and coat estimates
underlying its ucs than ss justifiable, in view
of the uncertainties present in both sets of
estimates. Therefore, although coat-psr-life
estimates maybe used for perspective in
considering control options, they will not be
used as decision rules m setting standards
under oection 112.
(3) "Best Technology". Requirements for
"best" control technology for emission
sources have been advocated as an interim or
ultimate approach which can be used without
difficult considerations at economics in
determining the degree of control required.
Although such a technology-based approach
at first appears relatively dimple to
implement, itio oaoii apparent that "best
available technology" cannot be defined by
technical cojiosderatieno alone. For example.
if an "add-on" control device achieves EOT.
control, than fc fcEotaUattom of an additional
unit af Duettos1 tspdbDMMeo ooiuld rsducs
V-Appendix C-18
-------
/ Vol. 44. Mo. 197 / Wednesday. October 10. 1979 / Proposed Rules
remaining emissions by an additional 60%.
Still further units could always be applied to
marginally reduce emissions. Clearly, at some
point in this process the costs associated
with marginal increases in control would be
grossly disproportionate to the incremental
reductions in emissions. Thus, "best
available technology" must be defined with
at least some reference to economic
considerations, as in the case of new source
performance standards under section 111 of
the Clean Air Act.
"Best available technology" as defined in
section 111 of the Clean Air Act may not be
an adequate level of control for purposes of
section 112. however, since "best available
technology" does not consider the health
risks remaining after its use. While "best
available technology" may prove a useful
starting point, therefore, it is not itself
sufficient for section 112 purposes without
consideration of the residual health effects.
C. Special Approaches for New Sources
A number of approaches and mechanisms
have been suggested to contain or minimize
increases in risks which may be associated
with operation of new sources of
carcinogenic air pollutants. It has been
argued that special requirements for new
sources are both necessary and justified
because (1) given existing uncertainties about
the health effects associated with exposures
to various levels of carcinogens, those
exposures should be limited as much as
possible, and (2) new sources can reasonably
consider control and risk avoidance options
not readily available for existing sources.
Several mechanisms for treatment of new
sources are discussed below.
(1) Stricter Standards for New Sources.
This approach would specify control
requirements for new sources that are more
stringent than those for existing sources. In
effect, this re simply a modification of the
best technology approach discussed above.
The approach does have the advantage of
limiting emissions from new facilities to a
greater degree than from existing facilities
under a best technology standard, and in that
sense can be said to contain the risk
somewhat.
The approach could also involve
consideration of residual risks associated
with projected typical new source siting
conditions. However, because it cannot
consider the residual health risks associated
with all of the varying sets of population
distributions in which a new source might
actually be located, the approach may not
provide sufficient protection under actual
conditions. Thus. like the best technology
approach for existing sources, this approach
can serve as a useful starting poinl, but is not
sufficient alone.
(2) Regional Emissions Offsets. An "offset"
policy would require a reduction in emissions
of a given carcinogenic air pollutant from
existing sources in an area as a precondition
for construction of new sources within a
specified distance of the existing sources. To
the extent that new sources desire to locate
near existing facilities, development of
improved emissions control technology
would be encouraged by this approach and
increases in risk to health beyond existing
levels would be prevented.
The disadvantages of this approach as a
general policy are that it would have no
effect at all on the establishment of sources
at new locations, and could prevent the
expansion of sources which have already
installed advanced technology or do not
present oignificant new risks. In short, It
employs the somewhat arbitrary assumption
that any increased risk in an area with
existing sources is not tolerable, but that
increased risks in areas with no existing
sources are permissible.
(3) National Emissions Freeze. Under this
option, additional emissions from new or
modified sources would be prohibited except
to the extent that offsets are obtained from
existing sources on a nationwide basis. This
approach would account for some of the
disadvantages of the regional emissions
offset approach. It also provides incentives
for technology-forcing and containment of
risk.
The main drawbacks of the approach are
that it presumes that any additional
emissions create an intolerable risk, and that
it would fail the most heavily on the newest
industries (those with the fewest existing
sources) and on those which have already
forced technology the most. It also fails to
provide incentives for careful siting of new
sources.
(4) Cose-by-Case Review of New Sources.
Under this approach, additional emissions in
populated or high risk areas would be
permitted only after consideration of residual
risks and other relevant factors associated
with each new source proposed. In this
review, special emphasis would be placed on
appropriate siting and the use of improved
control measures.
By evaluating risks, benefits, controls, and
siting on a case-by-case basis, this approach
could significantly limit risk without
arbitrariness and over-regulation problems of
either regional or nationwide offset
requirements. Yet by requiring individual
reviews, the pressure is maintained for both
careful siting of new sources and improving
technology where that appears necessary.
D. Judgmental Approaches
In contrast to the zero-oriented and fixed?
decision rule approaches outlined above,
"judgmental" approaches posit that the
degree of control which is appropriate for
airborne carcinogens cannot be
predetermined in the abstract for all cases
and, to some extent, depends on the
particular circumstances. Circumstantial
factors which might be considered, in
addition to the risk to public health, include
the costs of further control, the benefits of the
activity, the distribution of risk versus
benefits, and the availability of substitutes.
The use of a judgmental approach appears
desirable to the Administrator because it
permits him to take advantage of the strong
points of various available approaches
without suffering their drawbacks. The
specific approach chosen, however, must be
compatible with the mandate of section 112
to put principal emphasis on public health
protection, and each of the factors involved
must be assigned a weight consistent with
this principle.
Although protection of public health must
be paramount, the relative importance of
other factors can vary. Society may be willing
to pay more for control or accept higher
health risks associated with activities viewed
as important or essential. The distributional
aspects of control situations can differ even-
when the magnitude of risk, costs, and
benefits are similar. Moreover, differing
degrees of certainty in the cancer incidence.
economic, and benefits estimates can call for
different regulatory responses. Given this
variety of circumstances and the frequent
uncertainty of analyses, the Administrator
believes that it is important to consider
different situations on their own merits.
Judgmental approaches obviously place
great responsibility on decisionmakers to
weigh the relevant factors carefully and to
reach judgments in the best interest of the
public. The Administrator believes that such
responsibility, while heavy, is unavoidable if
protection of public health is to be maximized
within the constraints of a world of finite
resources. The policy contained in the
proposed rule is based on these views.
A. Congressonal Intent and the
Characteristics of Airborne Carcinogen
The main question the Administrator has
found it necessary to answer in arriving at
the interpretation of section 112 reflected in
today's proposal is whether Congress, in
enacting that section, had any specific intent
about how an ample margin of safety would
be derived in setting standards for air
pollutants with the characteristics of
carcinogens. If Congress had a specific intent,
that would of course be conclusive. If. on the
other hand, the situation presented by
regulation of airborne carcinogens under
section 112 falls in the interstices of
congressional intent, the Administrator is
required by established legal principles to
deduce and impute an intent in a reasonable
way that is consistent with the overall _
purposes and scheme of the statues."
(I) The focus of congressional attention:
"threshold" pollutants. In answering this
question, the Adminstrator has found it
helpful to recall the pollution problem that
Congress perceived and addressed in 1970,
when section 112 was enacted as part of a
major revision of the entire Act. The
legislative history of the Clean Air
Amendments of 1970 reveals that the
attention of Congress was at that time fixed
primarily on the two problems perceived to
be at the heart of the air pollution crisis:
stationary source emissions of various widely
prevalent pollutants such as sulfur dioxide.
particulate matter, and photochemical
oxidants; and automotive emissions of some
of the same pollutants. The statutory scheme
constructed for dealing with these pollutants
reflected congressional recognition of the
view that the pollutants have exposure
thresholds for adverse health effects: that is,
levels below which exposure to the pollutants
"See. e.g.. Mourning v. Family Publir.aln>;is
Serv.. Inc.. 411 U.S. 356. 371-373'(1973): A/urMn \:
Ruiz. 415 U.S. 199. 231 (1974): United Static v.
Southwestern Coble Co.. 392 U.S. 157.171-173
(1888): International Harvester Co. v. Rurki-lshnus.
478 F.2d 613. 648 (D.C. Cir.. 1973).
V-Appendix C-19
-------
Segiste / Vol. 414. Wo. 187 / Wednesday, Octobar 10. 1079 / Prapoosd
t be expected to reoult in adverse
health effects"
'Bacauoe it io seldom ocientifically feasible
to identify precisely the levels at which
thresholds occur, the location of a threshold
must be estimated some where below the
expooure level (the "demonstrated effects
level") at c^hich adverse health effects have
teen found to eccur in empirical research.
Congress therefore required in section 108 of
the Act that "margins of oaf sty" be
established to protect againot unknown
dangers below the demonstrated effects
levels. "The Administrator believes that
Congress intended health effects to be the
only consideration in setting standards under
section 109 under these circumstances, and
this view has governed the establishment of
national ambient air quality standards
{NAAQS) under section 109 to date."
Congress also incorporated the "margin of
safely" concept, used in section 109 in
dealing with the widespread apparent
threshold pollutants that were at the forefront
of its awareness into the requirements of
section 112. The Administrator believes that
this incorporation reflects both a parallel
intent and parallel assumptions. Thus section
112 standards set to protect against adverse
health effects characterized by a threshold
must also be based solely on health^6 with an
"ample" rather than an "adequate" margin of
oaTety to account for the greater severity of
the pollutants involved."The apparent
underlying congressional assumption,
however—the existence of thresholds—also
leads the Administrator to believe, in the
absence of significant contrary indications,
that Congress did not specifically foresee or
address the problems inherent in applying the
margin of safety concept to air pollutants
under fundamentally different circumstances.
(2) The carcinogen problem: no apparent
thresholds. Regulation airborne carcinogens
under section 112 does require the
application of the margin of safety concept
under fundamentally different circumstances.
Although carcinogens, as air pollutants which
may cause an increase in mortality, are
"Some physiological responses (not producing
adverse health effects) may occur at exposure levels
betonr the thresholds.
"S. Rep. No. 91-1 IBS, 91st Cong.. Zd Seas, af9-10
(1970).
"See. e.g.. *J PR 8202 (February 8,1879)
(revisions of ozone'Standard). Although Congress
heo precluded consideration of the feasibility of
attaining NAAQS in the standard-Belting process, it
has provided various means for feasilbilty factors to
be considered in connection with control of the
pollutants described in section 108. Control of
pollutants listed under section 108 can take account
of feasibility through opportunities for allocation of
the burdens of control by the slates under oeclion
110. through delays in compliance under sections
11XJd) and 110. and through attainment date
extensions under oeclion 110(e). Under section
111(d) of the Act. feasibility is taken into .account
directly in connection with control of certain
oimllar. but less ubiquitous, pollutants emitted by
discrete source categories.
"This view was recently endorsed in Hercules.
Inc. v. EPA. F.2d , 12 ERC 1376 (D.C. Cir.. W7B).
"This construction of the difference between
"adequate" and "ample" was recently expressed by
the U.S. Court of Appeals for the District of
Cojytnbia circuit in EDF(PCBs) v. EPA.—
12 F.RC 1353 (1978).
clearly among the pollutants that the
Administrator io required to regulate under
section 112 of the Act. carcinogens mtiot also
(for the reasons discussed earlier) be
regarded for public health .purposes as having
no identifiable adverse health affects
thresholds. Tfea method used to establish a
margin of cafety for a threshold pollutant—
setting the standard somewhere below the
demonstrated effects level at a point at which
the absence of advorcs health effects is
predicted—therefore cannot be .used to set
standards (oSter than fitsero) for carcinogens
under emotion 132.-atom tiok&tf cancer io
. believed to esiot at any exposure lavs!
greater than zero.
in establishing margins of safety for
carcinogens, therefore, the task is to
determine how low the risk of the occurrence
of cancer in an-exposed persons or the
projected incidence in an exposed-population
must be driven before a margin of safety can
be considered ample to protect the public
health. Only two approaches are available
for performing this tack: either the emission
standards must be set atsaro to eliminate the
risk of cancar incidence altogether, or come
residual risk must be permitted. Because
Congress did not give specific consideration
to this problem, the.Administrator does not
believe that section 112 expresses an intent.
to eliminate totally all risks from emissions of
airborne carcinogens.10 Saction 112 standards
which permit omall residual risks can, in the
•Administrator's judgment, therefore provide
an ample margin of safety to protect the
public health.
(3) The consequences of a zero-risk
requirement. This vie
-------
Federal Register / Vol. 44. Mo. 197 / Wednesday. October 10. 1979 / Proposed Rules
112. and the absence of comparable
specificity in section 112 suggests that "an
ample margin of safety to protect the public
health" need not be interpreted as requiring
the complete elimination of all risks.20
In interpreting the margin of safety concept
in section 112 of the Clean Air Act. moreover,
there is no reason to believe that Congress
intended to make air pollution practically the
sole facet of American life from which the
government would attempt to eliminate risk
entirely.
Not only is there no indication, as noted
above, that Congress considered the
inevitable consequences of such a decision,
but such an interpretation would also be
quite incongruous in view of the provisions of
numerous other public health statutes
enacted during or since 1970. These statutes
deal with, among other things, environmental
carcinogens to which people are equally or
more exposed, and they all permit
consideration of factors other than risk in
setting standards or taking comparable
actions.29
in particular, the recent enactment of the
Toxic Substances Control Act, which was
intended to address the problem of toxic
substances comprehensively, supports the
view that where Congress has specifically
considered the problem of reducing risks
posed by environmental exposure to
carcinogens, it has not required complete
elimination of those risks. Taken together, the
Administrator believes that these statutes
provide strong evidence that the complete
elimination of risk from environmental
exposure to carcinogens is not the task with
which he has been charged by Congress.
B. Ample margins of safety under section
112. For reasons stated previously, the
Administrator has concluded that section 112
does not require him to base all emission
standards for carcinogens on a criterion of
zero risk from exposure to such substances.
Once that proposition is accepted, at least
limited consideration of factors other than
the level of risk itself is unavoidable, since
some criteria are needed in order to judge
whether or not the degree of public health
protection associated with a particular
standard is "ample." M
The Administrator believes that section 112
clearly requires this determination to be
based primarily on risk. The Administrator
also believes, however, that he may consider
other social and economic factors in
determining whether an ample margin of
safety is provided by a given control level.
"That Congress might have chosen on absolute
safely rule for food additives, but not for air
pollution, is quite plausible on policy grounds. Cf.
Doniger. "Federal Regulations of Vinly Chloride,"
-------
ENVIRONMENTAL
PROTECTION
AGENCY
NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
GENERIC STANDARD
-------
Federal Register / Vol. 44. No. 197 / Wednesday. October 10, 1979 / Proposed Rules
40CFRPart61
[FRL 1254-2]
National Emission Standards for
Hazardous Air Pollutants; Advance
Notice of Proposed Generic Standards
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Advance notice of proposed
rulemaking.
OUMMARY: This notice sets forth draft
generic standards that EPA may propose
for sources of carcinogenic organic •
chemicals that are listed as hazardous
air pollutants under section 112 of the
Clean Air Act. Elsewhere in this issue of
the Federal Register EPA is proposing a
policy for the identification, assessment
and regulation of airborne carcinogens
under section 112. Under this policy,
EPA would employ generic standards
where applicable to reduce emissions of
airborne carcinogens. These generic
standards would be proposed
simultaneously with the listing of a
carcinogen as a hazardous air pollutant.
The intent of this notice is to solicit
comment on the generic standards EPA
is currently developing.
DATES: Written comments and
information should be postmarked on or
before December 10,1979.
ADDRESSES:
Comments: Written comments and
information should be submitted to the
Central Docket Section (A-130), U.S.
Environmental Protection Agency, Attn:
Docket No. A-79-13. 401 M Street SW,
Washington, D.C. 20460.
Docket: Docket No. A-79-13, containing
material relevant to this rulemaking, is
located in the U.S. Environmental
Protection Agency, Central Docket Section,
Room 2903B. 401 M Street, SW.,
Washington, D.C. 20460. The docket may
be inspected between 8:00 a.m. and 4:00
p.m. on workdays, and a reasonable fee
may be charged for copying.
FOB FURTHER INFORMATION CONTACT:
Environmental Protection Agency,
Office of Air Quality Planning and
Standards, Emission Standards and
Engineering Division (MD-13), Research
Triangle Park. North Carolina 27711.
Attention: Mr. Don R. Goodwin,
telephone number (919) 541-5271.
SUPPLEMENTARY INFORMATION: Section
112 of the Clean Air Act as amended, 42
U.S.C. 7412. requires EPA to regulate
hazardous air pollutants by establishing
emission standards and, where
necessary, certain other measures to
protect public health. The rapidly
developing body of knowledge
concerning toxicology indicates that
many air pollutants, primarily in the
form of airborne carcinogens, may
present significant risks to public health.
Many of these air pollutants will likely
be volatile organic chemicals. The
technical complexity and diversity of
the organic chemical manufacturing
industry and the stringency of Clean Air
Act time limits on regulation of
hazardous air pollutants indicate a need
to improve EPA's regulatory procedures
in this area. Accordingly, as a
significant part of the program for
regulation of airborne carcinogens
contained in the rule proposed
elsewhere in today's Federal Register,
EPA is developing generic standards for
use in reducing emissions of organic
chemical carcinogens listed under
section 112 in the future. The use of
generic standards would provide a
quick, first step in the regulation of
organic chemical air carcinogens.
Generic Standards
Generic standards used to regulate
emission sources of carcinogenic air
pollutants are standards which are
independent of process or chemical and
are based on the similarity of operations
and equipment throughout an industry,
such as the organic chemical
manufacturing industry. They can be
applied to similar emission sources and
represent reasonable and prudent
measures a responsible plant owner or
operator would take in dealing with a
carcinogenic air pollutant.
Consistent with the mandate of
section 112 that emissions of hazardous
air pollutants be reduced quickly,
generic standards would be proposed
for applicable emission sources
simultaneously with listing of a volatile
organic chemical determined to be an
airborne carcinogen. Depending on the
nature of the listed organic chemical and
the emission sources of this chemical,
generic standards may require
"tailoring" in certain cases to reflect
unique or unusual situations. Generic
standards and the rationale supporting
those standards would be published in
the Federal Register. Additional
documents outlining and summarizing
the information supporting the
standards would not necessarily be
published. However, supporting
information would be available at the
time of proposal for public inspection.
This supporting information would
include general assessments of the
economic, energy, and environmental
impacts of the proposed standards.
Proposal of generic standards for
applicable organic chemical emission
sources would be followed by a public
comment period and an opportunity for
a public hearing. EPA would evaluate
the comments submitted during the
public hearing and comment period,
make appropriate changes to the
proposed generic standards, and then
promulgate the generic standards.
Generic standards would be followed, in
most cases, by proposal of additional
standards. These additional standards
would be developed under the rule
proposed today for regulation of
airborne carcinogens.
As EPA identifies and develops
additional standards, an evaluation of
the reasonableness of including these
requirements in future generic standards
will be made. As a result, the generic
standards will evolve and become more
extensive as EPA's experience and
expertise increase.
Implementation of Generic Standards
As discussed below, the draft generic
standards focus primarily on reducing
fugitive emissions through the use of an
effective leak detection and repair
program. There are a number of possible
approaches to implementing these
generic standards. The first approach
would be to require the attainment of
specific performance levels by the
sources regulated. For example to
control fugitive emissions from pump
seals, a performance level could specify
that no more than a certain percentage
of pump seals leak. Achievement of the
performance level would be enforced
through tests of pump seals in a plant to
determine what percentage of seals
were leaking. If more leaks were found
than the percentage allowed by a
performance level, the source would be
out of compliance and enforcement
action would be taken. This approach,
therefore, Would be similar to the
approach followed in most existing new
source performance standards and
national emission standards for
hazardous air pollutants. Because this
approach would depend on testing,
rigorous enforcement of the standards
would be possible. This approach also
would provide each plant with complete
flexibility to institute its own method of
achieving and maintaining compliance
with the standards. Data to establish
specific performance levels, however, is
not currently available, although
programs underway may provide some
data which could be used for this
purpose. If the data developed by these
programs show that this approach is
feasible, future generic standards may
incorporate performance levels in some
areas.
A second approach to implementing
generic standards would be to specify
that certain work practices be followed.
For example, to control fugitive
emissions from pump seals, the
standards would specify (1) how often
pump seals must be inspected for leak*,
V-Generic-2
-------
/ Vol. Q&, No. 1S7 / Wednesday, October 10. H878 / Proposed Kules
(2) the detection technique and
procedure for determining if a leak
exists, and (3) the time period within
which any leak found must be repaired.
Compliance with work practice
requirements would be enforced through
examination of records kept by the plant
showing that inspections were carried
out, leaks detected, and repairs made.
Compliance would be monitored through
use of routine reporting. This approach
would, of course, provide less flexibility
to the plant owner or operator. The
reliance of this approach on self-
reporting and recordkeeping could make
enforcing generic standards difficult.
However, data and information are
currently available which allow the
development of work practice
requirements.
A third approach to implementing
generic standards would use the
standards as guidelines. Guidelines
would provide maximum flexibility in
the actions by industry; each plant could
tailor its method of locating and
repairing leaks to its particular situation.
Guidelines would also allow innovation
in control techniques. Guidelines,
however, would have no legal status.
Therefore, EPA could not enforce
compliance with guidelines. Given the
nature of the problem presented by
public exposure to hazardous air
pollutants and the requirements of
section 112, this approach is inadequate.
The Manufacturing Chemists
Association (MCA) has suggested an
approach similar to that of guidelines.
MCA's approach would require owners
and operators to prepare and implement
plant-specific plans for reducing fugitive
emissions of the hazardous air pollutant.
The draft generic standards would serve
as guidelines for developing these plans.
Plans could depart from the guidelines if
an owner or operator felt the departure
was justified.
MCA's suggested approach is similar
to an approach used by EPA in oil
pollution prevention regulation (40 CFR
Part 112) promulgated in 1973 and in
hazardous substance pollution
prevention regulation (40 CFR Part 151)
proposed in 1978 under the Clean Water
Act. This approach provides each plant
with flexibility and allows innovation in
control techniques, in the proposal,
enforcement of this approach is
triggered by an identifiable event, such
as discharge of hazardous substances in
harmful quantities as determined in 40
CFR Part 118, and focuses on a review of
the effectiveness of the plan.
Enforcement of this approach is
enhanced by surprise inspections which
focus on review of the plan. After
review of a plan, an owner or operator
may be required to amend the plan.
Also, the owner or operator is liable Sfor
a civil penalty for violations of
requirements of the regulation.
The plan preparation approach, if
used to implement generic standards,
would be enforced through review of e
plan to determine the effectiveness of
the plan. Review of each plan would be
required at some point in time. The
mechanism for triggering review could
be based on an identifiable event or
could be based on an automatic or
periodic review.
In the example of the proposed
regulation under the Clean Water Act,
review is triggered by an identifiable
event, such as a discharge. For emission
sources covered by the draft generic
standards, an identifiable event to
trigger review of a plan is not readily
apparent. These emission sources are
spread out in an organic chemical plant
and often require a measurement device
for detection. A mechanism for
triggering review other than the
identifiable event mechanism would be
necessary.
Another mechanism for triggering of
review plans would follow procedures
similar to those used under 40 CFR fart
51 for development of State
Implementation Plans. These procedures
would require automatic preparation of
plans and their submittal to EPA for
review. After a review to determine the
effectiveness of a plan, the plan would
be approved or disapproved. Approved
plans would be incorporated into 40
CFR Part 61, thus assuring their
implementation and allowing their
enforcement. Incorporating plans into 40
CFR Part 81 would be very time
consuming. The time and resources
required to review and determine the
effectivieness of a plan and then to
incorporate the plan into 40 CFR Part 61
prohibit the use of this mechanism.
Review of a plan to determine its
effectiveness is central to enforcement
of the plan preparation approach. The
use of an identifiable event to trigger
review of a plan does not appear
reasonable. The use of automatic review
procedures similar to those used under
40 CFR Part 51 is prohibited by the time
and resources required by the
procedures. Thus, the plan preparation
approach is limited in its usefulness.
EPA recognizes the general
desirability of the performance level
approach to generic standards.
However, data and information are not
available to develop these types of
generic standards at the present time.
Although EPA recognizes the possible
use of the plan preparation approach,
the time and resources required to
establish effective plans prohibit the
usefulness of this approach. Therefore,
in developing draft generic standards,
EPA has chosen the approach of
specifying detailed work procedures as
the most viable approach now available.
This is consistent wilh EPA control
techniques guidelines documents which
recommend this approach. SPA invites
public comment on advantages and
disadvantages of each of the approaches
discusesed above.
The draft generic standards are
outlined in Attachment A to this notice.
These draft standards would be
proposed for sources of carcinogenic
organic, chemicals listed under section
112 of the Clean Air Act. When
proposing generic standards for
regulation of carcinogenic organic
hazardous air pollutants, EPA would
evaluate the appropriateness of each
standard outlined in Attachment A.
Tailoring may be required and therefore
in some instances, additions to these
draft standards may be made, and in
other instances, deletions may be made.
To achieve the goal of expeditious
control of carcinogenic emission
sources, the draft generic standards
were based on the following selection
criteria. First, draft generic standards
were selected which are broadly
applicable to organic chemical emission
sources. Second, standards were
selected which lend themselves to quick
implementation and third, standards
were selected which do not require
substantial capital expenditure. Finally,
standards were selected which would
be consistent with any additional
standards promulgated later; thus, the
generic standards could be instituted
with confidence.
The draft generic standards categorize
emission sources of organic chemicals
into six groups. These groups are:
fugitive emissions, chemical storage,
chemical transfer and handling, waste
disposal, process vents, and air
pollution control devices. All of these
emission sources lend themselves to
control through the use of generic
standards. In accordance with the
selection criteria, the draft generic
standards would require control of these
emission sources, for the most part.
through the use of improved operation,
maintenance, and housekeeping
practices.
The major focus of the draft generic
standards is leak detection and repair.
The draft standards would require
inspection of potential fugitive emission
sources at specific intervals to locate
leaks which require repair. These
fugitive emission sources consist of
equipment which comes into contact
V-Generic-3
-------
Fates! Kogtota? / Vol. 4X1, No. W / Wedaaoday. Octote W, WSi I Prcpooed Ealeo
with any liquid or gaseous mixture
containing more than a specified
minimum concentration of the listed
pollutant. Inspection includes routinely
monitoring potential fugitive emission
sources to detect gaseous leaks, and
routinely observing sources to detect
liquid leaks. If an organic chemical
concentration greater than a defined
action level is measured at the interface
between the source and the atmosphere
using a portable detection device, it is
considered that a gaseous leak has been
detected. Upon monitoring, if a gaseous
leak is detected, the leak must be
repaired within a specified repair
interval. Upon observation, if a liquid
leak is detected, the emission source is
monitored. If a gaseous leak is detected.
then repair is required within the
specified repair interval. Repair of the
leak would be confirmed by monitoring
the source to determine that the
concentration is less than the defined
action level. Inspection intervals ranging
from weekly to annually are currently
being considered. Values of 1 to 10
percent for the minimum concentration
in the mixture, 5 to 15 days for the repair
interval, and 1,000 to 10,000 parts per
million by volume measured as hexane
(ppmv) as the action level or definition
of a leak are also currently being
considered.
If repair of a leak would result in more
emissions than cumulative emissions
from the leak prior to a scheduled
process or operation shutdown, or if
repair of a leak is not possible because
of location, service, or unavoidable
circumstances, the required repair could
be delayed pending approval of EPA.
EPA Regional Enforcement Divisions
must be notifed by telegram or
telephone within a specified number of
days of requests for delay in the repair
of a leak, and would retain the authority
to disapprove any requests. If, however,
EPA failed to respond within a specified
number of days to a request for delay in
repair of a leak, approval of the request
would be granted automatically. Values
of 2 to 5 days from the finding of a leak
for requesting of a delay, and 2 to 5 days
from receiving of a delay request for
EPA response to the request, are being
considered. Rather than follow this
procedure for all leaks, EPA is
considering this reporting procedure
only for requests for delays in repair of
excessive leaks. An excessive leak
would be defined as some emission
concentration greater than the current
1,000 to 10,000 ppmv range being
considered as the definition of a leak.
For example, an excessive leak could be
defined as a concentration of equal to or
greater than 100,000 ppm. Because either
of these approaches IB Eikely to require
excessive resources and may be difficult
to enforce, EPA is requesting comment
on their feasibility and alternative
approaches which could be employed.
The numerical values of the specific
requirements in the draft generic
standards were based on preliminary
evaluation of various engineering
studies. In moot cases, ihe requirements
are illustrated by a range of values that
are being considered. The inspection
intervals, which could vary from weekly
to annually for equipment in liquid
service and from monthly to quarterly
for equipment in gaseous service, were
based on data developed from test
programs conducted within refinery and
petrochemical plants. In general, the
inspection intervals are based on the
observed frequency of leaks and their
expected emission rates. Preliminary
evaluation of fugitive emission sources
within benzene production units of
petroleum refineries indicates that the
inspection interval influences potential
emission reduction more than other
factors, such as definition of a leak, or
repair interval. Currently, a monthly
inspection interval for equipment in
gaseous and liquid service appears the
most reasonable inspection interval.
The repair interval which ranges from
5 to 15 days was based on observations
in the petroleum refinery end
petrochemical industry and on expected
reporting requirements. In many cases,
repairs could be made sooner than 5
days. However, there are unavoidable
circumstances which can delay repair
beyond 5 days. Circumstances, such as a
plant's parts stock being depleted, are
generally avoidable. While a plant
normally stocks sufficient spare parts,
(there may be unique circumstances
leading to the depletion of a plant's
parts stock. Requests for delays in
repair of leaks will be approved only
where repair is likely to result in
emissions in excess of the emissions
resulting from the leak, or where repair
is not possible because of circumstances
which EPA considers unavoidable.
Thus, the objective in selecting the
repair interval was to select a time
interval consistent with the ability of a
plant to repair a leak expeditiously, but
not to select a time interval so short that
it requires plants to continually request
repair delays for repair of routine leaks.
Preliminary evaluation of fugitive
emission sources within benzene
production units of petroleum refineries
indicates that the emission reduction
gained by going from 15 to five days is
small. Thus, the 15-day repair interval is
currently conoidered reasonable.
The purpose of specifying a minimum
concentration level of the pollutant in
gaseous or liquid mixtures is to exclude
process streams with trace quantities of
ihe hazardous pollutant. The 10 percent
upper boundary for this concentration
level is based on analogy with the
current vinyl chloride national emission
otandard. The lower boundary of 1
percent io based on estimates that this
level, under certain conditions, would
allow emissions of less than 10 ppmv of
She hazardous air pollutant Preliminary
evaluation of fugitive emission sources
within benzene production units of
petroleum refineries indicates that the
10 percent minimum concentration level
is most reasonable. Going from 10
percent to 1 percent would greatly
increase the number of sources covered
by the standards without a
corresponding reduction in emissions.
Therefore, 10 percent is currently
considered the most reasonable
minimum concentration level.
A hexane-based definition of a
gaseous leak at 10,000 ppmv as defined
in an EPA control techniques guideline
document, "Control of Volatile Organic
Compound Leaks from Petroleum
Refinery Equipment" (EPA-850/2-76-
036), was considered the maximum for
use in regulating organic hazardous air
pollutants. The 1000 ppmv definition of a
leak is a simple reduction of the value in
the control techniques guideline. The
1000 ppmv value appears a reasonable
lower value because some leakage is
unavoidable for emission sources
covered by the draft generic standards.
The 10,000 ppmv and 1COO ppmv
concentrations would be measured at
the interface between the leak and the
atmosphere. These values are based on
a technical evaluation of leaks and are
not based on an evaluation of potential
health risk of leaks. Preliminary
evaluation of fugitive emission sources
within benzene production units of
petroleum refineries indicates that the
10,000 ppmv action level is more
reasonable than the 1000 ppmv action
level. Experience indicates that repair of
leaks will result in emission reduction
with an action level of 10,000 ppmv.
However, experience does not indicate
that repair of leaks with concentrations
between 10,000 and 1000 ppmv will
result in emission reduction. Therefore,
10,000 ppm is currently considered the
most reasonable action level.
Continuous area-wide monitoring to
measure ambient concentrations of
• specific hazardous organic compounds
was considered. EPA experience with
the effectiveness of area-wide
monitoring indicates that this technique
V-Generic-4
-------
Federal Register / Vol. 44. No. 197 / Wednesday, October 10. 1979 / Proposed Rules
is not as effective in locating leaks as a
seal-by-seal inspection, which is the
technique outlined in the draft generic
standards. The use of area-wide
monitoring may add to the effectiveness
of seal-by-seal inspection, but
experience indicates that this added
effectiveness in minimal. Also, area-
wide monitoring is a capital intensive
technique. Thus, continuous area-wide
monitoring seems impractical for the
draft generic standards.
On the other hand, some organic
chemical facilities currently have leak
detection and repair programs based on
continuous area-wide monitoring of
ambient air hydrocarbon
concentrations. In some cases, these
programs or other types of leak
detection and repair programs might be
as effective in reducing fugitive
emissions as the program described in
the draft generic standards. During
meetings with industry associations, it
has been suggested that an alternative
to requiring duplication of equally
effective leak detection and repair
programs should be developed. This
suggestion is reasonable. However, it
depends upon determining equivalency
of various programs with the draft
generic standards. Three basic criteria
seem necessary for any technique for
determining equivalency. These criteria
are: (1) the technique for determining
equivalency should minimize both
industry and Agency resource
requirements; (2) the type of data
necessary to demonstrate equivalency
should normally be available or easily
developed; and (3) the technique should
be quantitative, with little room for
discretion or argument concerning .
equivalency. EPA specifically invites
comments on possible approaches to
determining equivalency that meet these
criteria.
The draft generic standards also
include requirements for recordkeeping
and reporting. Recordkeeping and
reporting are considered necessary to
insure that the improved operation,
maintenance, and good housekeeping
practices generally required by the draft
generic standards are put into practice
quickly, effectively, and consistently.
Detected leaks would be recorded in a
log and the corrective actions noted
when a leak is repaired. EPA would be
notified on a quarterly basis of leaks not
repaired within the specified repair
interval; these quarterly reports would
include a listing of those units and
components which leaked past the
specified repair interval, date and
duration of these leaks, and
concentrations of the hazardous organic
chemicals. In some cases, recordkeeping
and reporting would be a duplication of
other EPA requirements. Where
duplication is unnecessary, duplication
would not be required in the generic
standards.
In early versions of the draft generic
standards, recordkeeping and reporting
requirements were the only measures
used to ascertain compliance with the
standards. In meetings with
environmental groups, it was suggested
that either EPA or a certified
independent contractor perform
scheduled inspections, observations and
monitoring to confirm compliance with
the standards. This suggestion would be
extremely burdensome on EPA
resources. Therefore, it has not been
included in the draft generic standards.
This suggestion, however, did lead to
incorporation of an approach requiring
the plant's owner or operator to notify
EPA one week prior to the date of
certain inspections, observations and
.monitoring. This would give EPA the
opportunity to observe these activities
and determine compliance with the
generic standards, without requiring
extensive resource commitments. EPA is
actively seeking specific comments on
this approach to enforcement of the
draft generic standards, and specific
comments on alternative approaches.
Minimal capital expenditure was a
criterion for selection of the draft
generic standards. The most readily
identifiable capital expenditure required
by the draft standards is the purchase of
the portable organic vapor monitor. The
cost of two such monitors used by EPA
totals about $10,000. A preliminary
estimate of annual leak detection and
repair costs for benzene production
units within a petroleum refinery is
about $25,000 per year. This estimate
includes the amortized cost of two
monitors, annual operating cost of the
monitors, annual cost of labor for leak
. detection, annual parts and labor cost
for leak repair, and annual cost of
administrative support. It does not,
however, include cost savings, which
could be significant, for the value of the
retained organic chemicals. EPA is
interested in specific information on the
cost of the draft generic standards.
The draft standards would also
require the owner or operator to submit
to EPA within four months following the
promulgation of a specific generic
standard an estimate of emissions of the
hazardous air pollutant. This estimate
would be based on nameplate operating
capacity and would be categorized by
emission source.
Specific Requests
EPA is requesting comments on the
approaches discussed under the
implementation of Generic Standards
section of this preamble. EPA is
interested in comment on other
..approaches for implementing generic
standards and is specifically interested
in any data and information which could
lead to the development of performance
level generic standards and means for
enforcing the plan preparation approach
advocated by MCA.
EPA is also interested in specific
comments on the following aspects of
the draft generic standards: (1)
identification of various operations,
procedures and equipment that are
sources of emissions of organic
chemicals; (2) identification of
demonstrated control techniques which
can be broadly applied to these sources
of emissions; (3) costs associated with
the requirements listed in the draft
generic standards; (4) standard
equipment, designs, or operating and
maintenance procedures (including
periods of start-up and shutdown) for
controlling emissions from operations
that may emit organic chemicals; (5)
comments on the various numerical
ranges included in the draft generic
standards; (6) comments on the
approach of requiring requests for
delays in repair of leaks or requests for
delays in repair of excessive leaks only,
and the specified levels of an excessive
leak; (7) identification of techniques or
procedures which could be used to
determine the equivalency of alternative
leak detection and repair programs; (8)
identification of ways to reduce the
burden of recordkeeping and reporting
on the source and EPA while
maintaining the effectiveness of the
draft generic standards; (9) the
enforcement approach of the draft
generic standards and alternative
approaches to the enforcement of these
standards; and (10) specific information
on leak detection and repair programs
similar to the program in the draft
generic standard; for each program, the
information should include (a) chemical
name and the process used to produce
the chemical, (b) a detailed description
of the leak detection and repair
program, (c) the number of pieces of
each type of equipment affected by the
program, (d) separate costs for
monitoring, equipment, installation of
equipment, labor for monitoring, repair
parts, labor for repair, and overhead,
and (e) an estimate of the emission
reduction potential and the product
recovery credits, including an
explanation of the estimation method.
This advance notice of proposed
rulemaking is issued under the authority
of sections 112,114, and 301(a) of the
V-Generic-5
-------
Register / Vol. 44, No. W / Wednesday, October 10, 3979 /
Clean Air Act as amended [42 U.S.C.
7412. 7414 and 7601(a)j.
Dated: August 22, 1979.
EaugiBo M. Coolie,
Administrator.
AttScrfirasal A—Kraft Generic Standards
/. Applicability
Except as noted below, these standards
would apply, for applicable emission sources.
to the owner or operator of equipment
affected by these standards. These standards
would affect equipment which comes into
contact with a liquid mixture containing 1
|10] percent or more by weight, or a gaseous
mixture containing 1 [10] percent or more by
volume, of organic chemicals listed by EPA
as carcinogenic hazardous air pollutants
under 8 112 of the Clean Air Act.
Nots.—Some requirements are illustrated
with one end of the range of values currently
being considered placed in brackets.
//. Fugitive Emissions
(A) All compressor seals and pipleline
valves in gaseous service shall be monitored
as provided in section IX (A) quarterly
(monthly). Whenever a concentration of 1.000
ppmv (parts per million by volume as hexane)
(10,000 ppmv] is detected, a leak exists.
Whenever a leak exists, it shall be repaired
within 5 (15) days, except as provided in
sections II (F) and (C).
(B) All pump seals, pipeline valves in liquid
service, and process drains shall be
monitored as provided in section IX (A)
annually (monthly). Whenever a
concentration of 1,000 ppmv (10.000 ppmv] is
detected, a leak exists. Whenever a leak
Bidets, it shall be repaired within 5 [15] days.
except as provided in sections II (F) and (G).
(C) Pressure relief valves, except those
vested to a control device, shall be monitored
as provided in section IX (A) quarterly
[monthly]. Whenever a concentration of 1.000
ppmv [10.000 ppmv] is detected, a leak exists.
Whenever a leak exists, it shall be repaired
within 5 [IS] days, except as provided in
sections II (F) and (G).
(D) Whenever a rupture disk installed
ahead of a pressure relief valve ruptures, it
shall be replaced within 5 (15) days.
(E) Pump seals shall be observed for liquid
leaks weekly as provided in section IX (B).
Whenever liquids are observed running or
dripping from a pump seal, the seal shall be
monitored as" provided in section IX (A).
Whenever a concentration of 1.000 ppmv
[10.000 ppmv] is detected, a leak exists.
Whenever a leak exists, it shall be repaired
within 5 |15] days, except as provided in
sections II (F) and (G).
(F) When repair would clearly result in
emissions in excess of the emissions resulting
from the leak, repair may be delayed, as
provided in section VIII (G), until a regularly
scheduled shutdown. In determining whether
emissions from repair of a leak would exceed
those resulting from the leak, cumulative
emissions over the time until the regularly
scheduled shutdown shall be considered.
(G) Where repair is not possible because of
location, service, or unavoidable
circumstances, repair may be delayed, as
provided in section VII! (G). until a time
when repair io possible.
(H) Houoetieeping practices.
(1) All liquid spills shall be cleaned uj)
within 8 (24] hours. Acceptable cleanup
methode include siphoning into a storage
container (e.g.. a portable spill tank).
chemical absorption end other appropriate
methods. Cleanup methods shall be in
compliance with requirements under 40 CFR
Part 151 (proposed).
(2) Wherever a valve io located at the end
of a pipe or line, 8Sie pipe or line shall be .
sealed with a cecond valve, blind flange, plug
or cap. Thin requirement does not apply to
pressure relief valves.
(3) Whenever liquid or gaseous samples are
taken from lines or equipment, a closeable
container shall be used and sample valves
shall be closed between samples. Liquid and
gas that is bled from cample lines shall also
be collected. All sample and bled material
shall be returned to the process or disposed
as provided in section V.
///. Chemical Storage
For storage equipment of greater than 40
[150] cubic meters capacity:
(A) All fixed-roof storage vessels exposed
to direct sunlight shall be painted while. No
more than 20 percent of the surface of the
storage vessel, or 20 square meters.
whichever is less, shall be covered with
writing and figures. This requirement shall
not apply to insulated, pressurized, or \
controlled temperature storage vessels and
storage vessels equipped with a refrigerated
condenser, carbon adsorber, incinerator, or
any combination of these.
(B) Tank connection flanges and manway
seals shall be monitored as provided in
section K (A) quarterly (monthly). Whenever
a concentration of 1.000 ppmv [10,000 ppmv]
is detected, a leak exists. Whenever a leak
exists, it shall be repaired within 5 [15] days.
except ao provided in sections II (F) and (G).
(C) Conservation vents on fixed roof
storage vessels shall be inspected and, if
necessary, maintained quarterly (monthly).
(D) Seals on floating roof storage vessels
shall be inspected and. If necessary,
maintained quarterly [monthly).
IV. Chemical Transfer and Handling
For equipment used in transferring and
handling to or from rail cars, tank trucks,
barges, and other transfer or transportation
vehicles, all seals and fittings, excluding
flanges, shall be monitored as provided in
section IX (A) quarterly (monthly). Whenever
a concentration of 1000 ppmv [10,000 ppmv] is
detected, a leak exists. Whenever a leak
exists, it shall be repaired within 5 [15] days.
except as provided in sections II (F] and (G).
V. Waste
(A) For waste covered by regulation under
the Resource Conservation and Recovery Act
(RCRA) and containing greater than 1 (10]
percent by weight of a pollutant affected by
section 1, the following requirements would
apply:
(1) Waste from sampling shall be disposed
by returning it to the process otream, by
reducing it in an appropriate air pollution
control device, or by absorbing or adsorbing
it with a liquid or solid. These absorbents
and adoorbento. attempt those returned to the
process stream, shall then ba wastes.
(2) Waste shall bs stored in vapor-tight
containers.
(3) A Regional Administrator may require
an owner/operotor, who is demonstrating
that treatment or disposal of B volatile waste
(i.e., greater than ?8 mm Hg) will not
contribute airborne contaminant to the
atmosphere, as provided In the NOTE In 40
CFR 250.45 (proposed), to demonstrate that
treatment or disposal of the pollutant affected
by section I will not contribute the eirbomo
contaminant to the atmosphere such that
concentrations above the source have the
potential to increase risk to the public.
(B) For waste containing greater then 1 (10)
percent by weight of a pollutant affected by
section I and not covered by regulation under
RCRA. the following requirements would
apply:
(1) Disposal and treatment of waste shall
be in compliance with standards for
treatment/disposal, as provided in 40 CFR
250.45 (proposed).
(2) Disposal and treatment of waste shall
be in compliance with sections V(A) (1), (2),
and (3).
VI. Process Vents
Where a process vent may emit a
hazardous organic chemical or any mixture
containing 1 [10] percent or more by volume
of hazardous chemicals, procedures
describing process operation, including start-
up, ohutdown, normal end emergency
procedures, shall be written and available to
appropriate process operators. Operators
shall receive an annual minimum of two
hours of training in these procedures.
VII. Air Pollution Control Devices
Where a control device is used to reduce
air pollutant emissions of o hazardous
organic chemical, procedures outlining
normal and emergency procedures for the
control devica shall be written and available
to all operators. These procedures shall
include at least all operating and
maintenance procedures recommended by
the control device manufacturer. Operators
shall receive an annual minimum of two
hours of training in these procedures.
VIII. Recordkeeping and Reports
(A) When a leak is detected, the presence
of the leak shall be noted on a survey log as
illustrated in Figure 1. Other information as
shown shall be included on this survey log.
Figure 1 is used to illustrate the minimum
acceptable information to be recorded and is
not a required form. A weatherproof and
readily visible tag bearing en identification
number and the date that the leak was
detected shall be affixed to the leaking
component. After the leak has been repaired.
the remaining portion of the survey log shall
be completed and the tag discarded. The
survey log shall be retained for at least two
years after the repair is completed.
(B) Quarterly reports shall be submitted to
the appropriate EPA Regional Office,
Enforcement Division Director. Each report
shall include a list as shown in Figure 2 of oil
leaks that were located since the last report
and not repaired within 5 [15] days. Each
report shall include a oeparate list as ohown
V-Generic-6
-------
Fodoffol KegisB®? / Vol. 44, No. 197 / Wednesday, October 10. 1979 / Proposed Rules
in Figure 2 of all leaks which were reported in
a previous quarterly report and which have
not been repaired. In addition, each report
shall include a statement signed by the plant
manager confirming that all weekly,
(monthly), quarterly and annually inspecting,
observing and monitoring has been
performed.
(C) When a spill occurs, records of the date
and the time of the spill and the cleanup shall
be maintained for a minimum of two years.
The records shall include an estimate of the
quantity of the lost material, concentration of
hazardous organic chemical, actions taken
for the cleanup, and method of final disposal.
(D) When an owner or operator must
comply with requirements in section VI,
records of the times and approximate
duration of all safety valve discharges shall
be maintained for a minimum of two years. A
nummary of these safety valve discharges
shall be reported annually to the appropriate
EPA Regional Office, Enforcement Division
Director.
(E) Written operating procedures as
described in sections VI and VII shall be
maintained and updated as necessary.
(F) Within four months of the date of
promulgation of this section, the owner or
operator of any facility subject to this section
shall submit to the Administrator an
evaluation of the emissions from the sources
of the hazardous pollutant specified in this
paragraph. This evaluation shall be an
engineering estimate and shall be subject to
the approval of the Administrator. The
evaluation shall include as a basis the
nameplate production rate, include the
appropriate operating production rate,
provide estimation of mass emissions from
the sources in sections, II, HI, IV, V, VI, and
VII. and explain the technique for the
estimation.
(G) A request for delay in repairing a leak
must begin within two [five] days after
locating the leak. The owner or operator
making a delay request shall provide by
telephone or telegram all necessary
information for making an evaluation at the
time of the initial request to the appropriate
EPA Regional Office, Enforcement Division
Director, and as required by the EPA
Regional Office. In evaluating the request, the
EPA Regional Office will consider the
expected length of the delay, the reasons for
the delay, the consequences of no delay, and
other relevant factors. If the EPA Regional
Office does not deny a requested delay
within two (five) days after receipt of the
request, the delay request will be granted
automatically.
(H) Whenever an owner or operator is
unable to comply with the two (five)-day
requirement as provided in section VIII (G),
he shall notify by telephone or telegram the
appropriate EPA Regional Office.
Enforcement Division Director, within one
working day after determining the inability to
comply. When notifying the appropriate EPA
Regional Office, the owner or operator shall
provide an explanation of the inability to
comply with section VIII (G). In evaluating
the inability to comply with section VIII (C),
the EPA Regional Office shall consider the
reasons for the inability to comply. After
evaluation, the EPA Regional Office may
• allow application of section VIII (G) for delay
requests after two [five] days after the plant
locates a leak.
(I) At least one working week prior to each
[monthly], quarterly, or annual inspections,
observations, and monitoring, an owner or
operator shall notify the appropriate EPA
Regional Office, Enforcement Division
Director, by telephone, or telegram that such
Inspections, observations, or monitoring are
ocheduled.
IX. Test Methods
(A) Monitoring hazardous organic
chemicals emissions.
This test method describes the procedures
used to detect volatile organic chemical
(VOC) leaks from sources of hazardous air
pollutants. A portable test device is used to
survey individual equipment leak sources.
The specifications and performance criteria
for the test instrument are included.
(1) Apparatus.
(a) Monitoring Instrument.
The VOC detection instrument used in this
procedure may be of any type that is
designed to respond to total hydrocarbons.
The instrument must incorporate appropriate
range options so that source levels can be
measured. The instrument will be equipped
with a pump so that a continuous sample is
provided to the detector. The instrument
meter readout will be such that the scale can
.be read to ±5 percent at 1,000 ppmv [10,000
ppmv). The instrument must be capable of
achieving the performance criteria given in
Table 1. The definitions and evaluation
procedures for each parameter are given in
oubcategory (3).
^.—Monitoring Instrument Performance
Criteria
Pcrorrater
Spstiftcatton
1. Zero drift (2-hour) ...„
2. Calibration drift (2-hour)..
3. Calibration error..
4. Response Urns....
s 5 ppmv.
. s 5% of the calibration
gas value.
. s 5% of the calibration
gao value.
. s S seconds.
The instrument must be subjected to
the performance evaluation test prior to
being placed in service and every three
months thereafter.
The performance evaluation test is
also required after any modification or
replacement of the instrument detector.
(b) Calibration Gases.
The VOC detection instrument is
calibrated so that the meter readout is in
terms of ppmv hexane. The calibration
gases require for monitoring and
instrument performance evaluation are a
zero gas (air, <3 ppmv hexane) and a
hexane in air mixture of about 1,000
ppmv [10,000 ppmv]. If cylinder
calibration gas mixtures are used, they
must be analyzed and certified by the
manufacturer to be within ±2 percent
accuracy. Calibration gases may be
prepared by the user according to any
accepted gaseous standards preparation
procedure that will yield a mixture
accurate to within ±2 percent.
Alternative calibration gas species may
be used in place of hexane if a relative
response factor for each instrument is
determined so that calibrations with the
alternative species may be expressed ao
hexane equivalents on the meter
readout.
(2) Procedures.
(a) Calibration.
Assemble and start up the VOC
analyzer according to the
manufacturer's instructions. After the
appropriate warm-up period and zero or
internal calibration procedure, introduce
the 1,000 ppmv [10,000 ppmv] hexane OF
hexane equivalent calibration gas into
the instrument sample probe. Adjust the
instrument meter readout to correspond
to the calibration gas value.
(b) Individual Source Surveys.
Place the instrument sample probe
inlet at the surface of the component
interface where leakage could occur.
During sample collection, the probe
should be moved along the interface
surface with special emphasis placed on
positioning the probe inlet at the local
upwind and downwind side of the
component interface. This general
technique is applied to specific types of
equipment leak sources as follows:
(i) Valves—The most common source
of leaks from block (glove, plug, gate,
ball, etc.) and control valves is at the
seal between the stem and housing. The
probe should placed at the interface
where the stem exits the seal and
sampling should be conducted on all
sides of the stem. For valves where the
housing is a multipart assembly, or
Where leaks can occur from points other
than the stem seal, these sources should
also be surveyed with the probe inlet
moved along the surface of the interface.
(ii) Flanges and other connections—
For welded flanges, the probe should be
placed at the outer edge of the flange-
gasket interface and samples collected
around the circumference of the flange.
For other types of non-permanent joints
such as threaded connections, a similar
traverse is conducted at the component
interface.
(iii) Pumps and compressors—A
circumferential traverse is conducted at
the outer surface of the pump or
compressor shaft and housing seal
interface. In cases where the instrument
probe cannot be placed in contact with
a rotating shaft, the probe inlet must be
placed within one centimeter of the
shaft-seal interface. In those cases
where the housing configuration of the
pump or compressor prevents the
complete traversing of the seal
periphery, all accessible portions of the
shaft seal should be probed. All other
joints where leakage could occur will
V-Generic-7
-------
Federal Register / Vol. 44. No. 197 / Wednesday. October 10. 1979 / Proposed Rules
also be sampled with the probe inlet
placed at the surface interface. For
pumps or compressors using sealing oil,
the vent from the seal oil reservoir will
be sampled by placing the probe inlet at
approximately the centroid of the vent
area to atmosphere.
(iv) Pressure relief devices—The
physical configuration of most pressure
relief devices prevents sampling at the
sealing surface interface. However, most
devices are equipped with an enclosed
extension, or horn. For this type device.
the probe inlet is placed at
approximately the centroid of the
exhaust area to atmosphere.
(v) Process drains—For open process
drains, the sample probe inlet will be
placed at approximately the centroid of
the area open to the atmosphere. For
covered drains, the probe should be
placed at the surface of the cover
interface and a circumferential traverse
shall be conducted.
(3) Instrument performance evaluation
procedures.
(a) Definitions.
Zero Drift—The change in the
instrument meter readout over a stated
period of time of normal continuous
operation when the VOC concentration
at the time of measurement is zero.
Calibration Drift—The change in the
instrument meter readout over a stated
period of time of normal continuous
operation when the VOC concentration
at the time of measurement is the same
known upscale value.
Calibration Error—The difference
between the VOC concentration
indicated by the meter readout and the
known concentration of a test gas
mixture.
Response Time—The time interval
from a step change in VOC
concentration at the input of the
sampling system to the time at which 95
percent of the corresponding final value
is reached as displayed on the
instrument readout meter.
(b) Evaluation Procedures.
At the beginning of the instrument
performance evaluation test, assemble
and start up the instrument according to
the manufacturer's instructions for
recommended warmup period and
preliminary adjustments.
(i) Zero and calibration drift test-
Calibrate the instrument per the
manufacturer's instructions using zero
gas and a calibration gas representing
about 1,000 ppmv (10,000 ppmv]. Record
the time,, zero, and calibration gas
readings (example data sheet shown in
Figure 3). After 2 hours of continuous
operation, introduce zero and
calibration gases to the instrument.
Record the zero and calibration gas
meter readings. Repeat for three
additional 2-hour periods.
(ii) Calibration error test—Make a
total of nine measurements by
alternately using zero gas and a
calibration gas mixture corresponding to
about 1,000 ppmv [10,000 ppmv]. Record
the meter readings (example data sheet
shown in Figure 4).
(iii) Response time test procedure—
Introduce zero gas into the instrument
sample probe. When the meter reading
has stabilized, switch quickly to the
1.000 ppmv (10.000 ppmv] calibration
gas. Measure the time from
concentration switching to 95 percent of
final stable reading. Perform this test
sequence three (3) times and record the
results (example data sheet given in
Figure 5).
(iv) The calibration error test and the
response time test may be performed
during the zero and calibration drift test.
(c) Performance Calculations.
All results are expressed as mean
values, calculated by:
1
IT
n
i
1 = 1
Xi
where:
Xi
value of the measurements
£ = sum of the individual values
x = mean value (the absolute value of the
mean value)
n = number of data points
The specific calculations for each
performance parameter are indicated on
the respective example data sheet given
in Figures 3, 4, and 5. The example data
sheets are constructed so that
performance criteria tests can be
conducted on 1.000 ppmv [10,000 ppmv]
levels of gas.
(B) Observing for liquid leaks of
hazardous organic chemicals.
This test method describes the
procedures used to detect organic
chemical liquid leaks from sources of
hazardous air pollutants. The method
uses visual observations to determine
the existence of a liquid leak.
(1) Apparatus.
No apparatus is needed to perform
this method.
(2) Procedure.
Observing from vantage points to
sufficiently inspect the source.
determine if any chemicals are leaking
A liquid leak exists if any chemical
liquid is observed running or dripping
from the surface of the source. When a
chemical liquid is dripping to a surface
which is in the vicinity of a possible
hazardous pollutant emission source,
locate the source of the liquid.
V-Generic-8
-------
Federal Register / Vol. 44. No. 197 / Wednesday, October 10,1979 / Proposed Rule*
Instrument
Leak Detection and Repair Survey Log
Recorder:
TAG
NUMBER
UNIT
COMPONENT
•
HAZARDOUS
ORGANIC
CHEMICAL
CONCENTRATION
IN STREAM
DRAFT
DATE
LEAK
LOCATED
DATE
MAINTEN-
ANCE
PERFORMED
Operator:
COMPONENT RECHECK
AFTER MAINTENANCE
DATE
INSTRUMENT
READING
(PPM)
FIGURE 1. Example Monitoring Survey Log Sheet.
TAG
NUMBER
UNIT
•
COMPONENT
HAZARDOUS
ORGANIC
CHEMICAL
CONCENTRATION
IN STREAM
DRAf
DATE
LEAK
LOCATED
T
DATE
MAINTEN-
ANCE
PERFORMED
DATES
MAINTEN-
ANCE
ATTEMPTED
REASONS* REPAIRS POST-
PONED OR FAILED
FIGURE 2. Example Leak Report.
V-Generic-9
-------
Federal Register / Vol. 44. No. 197 / Wednesday. October 10.1979 / Proposed Rules
Instrument ID:
Calibration Gas Data:
ppmv
Date and Time
Zero
Reading
ppmv
Zero
Drift
ppmv
Calibration
Gas Reading1
ppmv •
Calibration
Drift
ppmv
Start
1.
2.
3.
4.
DRAFT
Mean (1)
Value:
Zero
Drift =
ppmv
^"ration Drift =
(1)
Absolute Value
Figure 3. Zero and Calibration Drift Determination
Instrument ID
Calibration Gas Mixture Data
Run
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Calibration Gas Instrument Meter
Concentration, ppmv Reading, ppmv
DRAFT
Difference, (1;
ppmv
Mean Difference'2^
Calibration Error = •*
Mean Difference
(2)
Calibration Gas Concentration
Instrument ID
Calibration Gas Concentration
ppmv
95X Response Time:
1.
2.
3.
Seconds
"Seconds
"Seconds
DRAFT
Mean Response Time
Seconds
Figure 5. Response Time Determination
[-{(Calibration Gas Concentration - Instrument Reading)
'''Absolute Value
Figure 4. Calibration Error Determination
V-Generic-10
-------
ENVIRONMENTAL
PROTECTION
AGENCY
NATIONAL EMISSION STANDARDS
FOR HAZARDOUS AIR POLLUTANTS
RADIONUCLIDES
-------
Federal Register / Vol. 44, No. 249 / Thursday, December 27,1979 / Noticed
ASSwev: Environmental Protection
Agency.
A@YC©M: Addition to List of Hazardous
Air Pollutants.
V: This notice announces the
Administrator's decision to list
radionuclides as hazardous air
pollutants under Section 112 of the
Clean Air Act.
ADDRESSES: Docket No. A-79-11,
containing material relevant to this
action, is located in the U.S.
Environmental Protection Agency,
Central Docket Section, Room WSM-
2803B, 401 M Street, SW. Washington,
DC. The Docket may be inspected
between 8 a.m. and 4 p.m. on weekdays,
and a reasonable fee may be charged for
copying.
! OMFOWMAYIIOM eOMTflgT:
James M. Hardin, Office of Radiation
Programs (ANR-460), U.S.
Environmental Protection Agency,
Washington, D.C. 20460, telephone (703)
557-8810.
oypFUSCJEKiTOKiv owF©R!ffiiATii©i?3: Section
122 of the Clean Air Act as amended in
1877 directs the Administrator of the
Environmental Protection Agency, after
notice and opportunity for public
hearing, to review all relevant
information and determine whether
emissions of radioactive pollutants will
cause or contribute to air pollution
which may endanger public health.
Therefore, the Agency published a
notice which called for relevant
information and data on radioactive air
pollutants and offered to hold a public
hearing (44 FR 11707; April 11, 1979). All
written comments received were
considered in today's decision. Copies
of these comments are to be found in the
Agency's Central Docket No. A-79-11.
None of the commentors suggested
that radioactive air pollutants do not
endanger public health. Several
commentors provided information on
the release of specific radionuclides into
the atmosphere. One commentor
requested that the comment period
remain open until completion of the
third report of the National Academy of
Sciences' Advisory Committee on the
Biological Effects of Ionizing Radiation
(EEIR). We do not believe such a delay
is appropriate because the BEIR III
Report is unlikely to change
substantially the conclusions of the first
(1972) BEIR Report regarding the
carcinogenic effects of radionuclides.
We have received a summary of the
BEIR III Report which supports this
opinion. If the report is completed as
scheduled, we will consider its findings
in formulating any proposed standards.
Public hearings will be held when
standards are proposed and comments
on the BEIR III Report, if it is used in
formulating the standards, will be
welcomed at that time.
One commentor requested that the
Agency hold a hearing after we make &
preliminary determination and decide
on our legal, scientific, and economic
positions so that informed public
comment is possible on these issues
before the final determination is made.
We do not believe that such a public
hearing is either required or useful. The
intent of Section 122 is to insure that the
Agency has an opportunity to consider
any information not previously
considered, or to call specific attention
to particular information on the
emissions of, and health effects from, air
pollutants that may be hazardous. In
EPA's view, Section 122 does not require
what would essentially be a proposed
listing notice end hearing. This view is
based on the language and history of
Section 122 and on the fact that a full
hearing on those topics will be available
after proposal of standards under
Section 112.
Section 112 of the Act directs the
Administrator to publish and from time-
tc-time to revise a list of air pollutants
which, in his judgment, probably causes,
or contributes to, an increase in
mortality or serious illness and to which
no national ambient air quality standard
applies. Within ISO days after the
inclusion of any air pollutant in the list,
the Administrator must publish
proposed regulations establishing
emission standards for such a pollutant,
together with a notice of a public
hearing to be held within 30 days.
In accordance with the requirements
of Sections 122 and 112, the Agency
finds that studies of the biological
effects of ionizing radiation indicate that
exposure to radionuclides increases the
risk of human cancer and genetic
damage. Also, the Agency finds that
emission data indicate that
radionuclides are released into air from
many different natural and man-made
sources with the result that everyone is
exposed to them. Further information on
these findings is given in Appendix 1
(biological effects) and Appendix II
(emission data) of this notice.
Based on this information, the
Administrator has concluded that
emission of radionuclides may
reasonably be anticipated to endanger
public health, and that radionuclides
constitute hazardous air pollutants
within the meaning of the Clean Air Act.
In making this determination, the
Administrator has consulted with the
Nuclear Regulatory Commission (NRC)
as required by Section 122. Among the
radionuclides included are those defined
by the Atomic Energy Act as source
material, special nuclear material, and
byproduct material.
In accordance with Section
112(b)(l)(A) the Administrator hereby
amends the list of hazardous air
pollutants:
List of Hazardous Air Pollutants
o ft a o o
a. Radionuclides
Dated: November 8,1979.
HDouglas M. Coslle,
Administrator.
A. EPA's Current View. An extensive
body of research has demonstrated that
carcinogenic!ty and mutagenicity are
associated with ionizing radiation and,
therefore, with exposure to
radionuclides. Exposure to enough
ionizing radiation increases the risk of
most forms of cancer, including
leukemia, lymphoma, and cancers of the
lung, bone, thyroid, breast, skin,
stomach, pancreas, esophagus, pharynx,
large intestines, and others. When germ
cells of the ovary or testis are exposed
to enough radiation, the risk of
mutagenesis is increased which, in turn,
may cause increased mortality and
illness in future generations. For very
low doses there is no conclusive
evidence of the risk involved.
The relationships between specific
radiation doses and risks to health are
extremely complex. They depend on
physical parameters, such as the energy
and type of radiation (e.g., alpha, beta,
or gamma radiation), total dose, dose
distribution within the body, and dose
rate. In addition, many biological
factors, such as the specific organ
exposed, the radiosensitivity of the
individual exposed, errors that occur in
biological repair mechanisms, sex, race,
age at time of exposure, genetic
composition, and state of health, may
influence the effects of radiation. These
factors involve complex mechanisms of
interaction among biological, chemical,
and physical systems, which are further
complicated because people are also
exposed to other factors such as tobacco
@moke and industrial chemicals, which
V-Radionuclides-2
-------
Federal Register / Vol. 44. We. 243 / Thursday, December 27, 1979 / Notices
MMMl^^^^MHMMHMIM^^HMaiMMKK^Z-^T JSTrarjamnn^^^M^^^H^HMIHB^^HaMMMB^^^^^H^BMMMIMMHMM
may change the magnitude of radiation
effects.
Although there is no conclusive
evidence of the effects of very low doses
of radiation on human populations, the
Agency assumes that the effects of low
doses of radiation are proportional to
the dose received in estimating the
health impact of possible low-level
radiation protection standards. We
believe this assumption is reasonable
and prudent in the light of presently
available evidence (1).
The information used by the Agency
in formulating these estimates of the
biological effects of radiation exposure
and the relationships between radiation
dose and the effects on public health has
been summarized in publications by the
National Academy of Sciences (NAS)
(2), the United Nations Scientific
Committee on the Effects of Atomic
Radiation (UNSCEAR) (3), and the
International Commission on
Radiological Protection (ICRP) [4). These
bodies agree that high levels of radiation
cause cancer and mutations and that a
sensible regulatory approach is to
consider risk to be proportional to
radiation dose at all low doses.
B. The Basis ofEPA's View. The first
human cancer attributed to external
ionizing radiation was reported in 1902
from X-ray exposures (5). By 1911,94
cases of radiation-related skin cancer
and five cases of leukemia in man had
been reported in the literature (6).
Studies from 1910 to 1912 produced the
first reports of radiation induced
cancers in experimental animals (7, 8).
In 1921, the first association between
inhaled radionuclides and
carcinogenesis in humans was made by
Uhlig for radon exposure and lung
cancer in underground miners in the Erz
Mountains of Austria, and
Czechoslovakia (9). This association
was reaffirmed by Ludewig and
Lorenser in 1924 (10). Swallowing
radium was shown to cause bone
necrosis (11), and in 1929, Martland and
Humphries reported the association of
swallowed radium and osteosarcoma in
occupationally exposed workers (12).
In more recent times, several studies
of human populations have conclusively
shown that sufficient exposure to
radiation increases the risk of many
different kinds of cancer. Among the
most significant of these are the
following:
a. Survivors of the atomic bomb
explosions at Hiroshima and Nagasaki,
[apan (13).
b. Two large groups of medical
patients given X-ray therapy or
injections of radium-224 for ankylosing
jpondylitis of the spine (3).
c. Groups of women whose breasts
were exposed to X-rays during
diagnostic radiation of the thorax or
during radiotherapy for benign
conditions (3j.
d. Patients medically treated with X-
rays, most'.y to the head and neck, for
the alleviation of otherwise benign
conditions (3).
e. Underground miners exposed to
elevated levels of radon (3).
f. Persons v/hc ingested radium-226
either for medical purposes or in the
course of their occupations (2,3).
g. Patients injected with thorotrast
(colloidal thorium dioxide) as an x-ray
contrast medium (14,15).
h. Children exposed in utero to
diagnostic x-rays (2,3).
Extensive ehidias in experimental
animals, especially rodents, and studies
of cell cultures support the idea that
ionizing rsdie.tion can cause mutations.
Animal studies have shown that ionizing
radiation can cause many types of
mutations: lethal mutations,
translocations, inversions,
nondisjunction, and point mutations
(2,3). Extrapolations of mutation rates
calculated in these studies form the
basis for estimating the genetic
(hereditary) impact of ionizing radiation
in humans (2,3).
Although genetic damage to the
children of irradiated persons has not
been identified, chromosome
aberrations in somatic cells have been
observed in persons exposed to ingested
strontium-90 and radium-226 (16),
inhaled/ingaotsd radon-222 (17),
inhaled/ingeoted plutonium-239 (17),
inhaled radon-222 (18), and also in
lymphocytes from atomic bomb
survivors (19) and shipyard workers at
nuclear facilities in England (20).
REFERENCES
1. United States Environmental Protection
Agency. Policy Statement on Relationship
Between Radiation Dose and Effect; March 3,
1975 (47. PR 203408, July 9,1976).
2. Advisory Committee on the Biological
Effects of Ionizing Radiations. The Effects on
Populations of Exposure to Low Levels of
Ionizing Radiation. National Academy of
Sciences, Washington, D.C. (1972).
3. United Nations Scientific Committee on
the Effects of Atomic Radiation (UNSCEAR).
Sources and Effects of Ionizing Radiation.
United Nations, New York (1977).
4. International Commission on
Radiological Protection. Publication 26,
Radiation Protection, Pergamon Press. New
York (1977).
5. Frieben, A. Demonstration lines
cancroids des rechten Handmckens, das sich
nach langdauemder Einwirkung von
Rontgenstrahlen entwickelt hatte. Fortschr.
Geb. Rontgenstr. 0:1096 (1902) cited by Upton
(6).
6. Upton, A.C. Physical Carcinogenesis:
Radiation—History and Sources, pp. 387-403
in Cancer 1, F. P. Becker, editor. Plenum
Press. New York (1975).
7. Marie, P., Clunet, ]., and Raulot-Lapointe,
G. Contribution a letude du developpement
des tumours malignes Buries ulceres de
roentgen. Bull. Assoc. Franc. Etude Cancer
3:404 (1910) cited by UNSCEAR (3).
B. Marie, P., Clunet, ]. and Raulot-Lapointe,
G. Nouveau cos de tumeur maJigne
provoquee par une radiodermite
experimental chez le rat blanc. Bull. Assoc.
Franc. Etude Cancer 5:125 (1912) cited by
UNSCEAR (3).
9. Uhlig, M. Uber den Schneeberger
Lungenkrebs. Virchows Arch. Pathol. Anat.
230:76 (1921).
10. Ludewig, P. and Lorenser, E.
Untersuchung der Grubenluft in den
Schneeberger Gruben aufden Gehaltan an
Radiumemanation. Zschr. f. Phys. 22:178
(1924).
11. Hoffman, F. L. Radium (Mesothorium)
Necrosis. J.A.MJV «5:961 (1925).
12. Martland, R S. and Humphries, R. E.
Osteogenic Sarcoma in Dial Painters Using
Luminous Paint Arch. Pathol., 7:406 (1929).
13. Beebe, G. W.. Kato, R and Land. C E.
Mortality Experience of Atomic Bomb
Survivors, 1950-1974. Life Span Study Report
8, RERF TR1-77. Radiation Effects Research
Foundation, Japan (1977).
14. International Meeting on the Toxicity of
Thorotrast and Other Alpha-Emitting Heavy
Elements, Lisbon, June 1977 (to be published
in Environmental Research).
15. Kaul, A. and Muth. H. Thorotrast
Kientica and Radiation Dose. Rad. and
Environm. Biophys 15:24,259 (1978).
16. Tuscany, R. and Klener, V. Pokles
Euploidie v Bunkach Kostni Drene osob s
Vnitmi Kontaminaci Kekterymi
Radioisotopy CM. FysioL 12:391 (1963).
17. Brandom. W. F., et al. Somatic Cell
Chromosome Changes in Humana Exposed to
*" Plutonium and *** Radon. Contract No.
E(29-2)-3639, Progress Report July 1,1976
through September 30,1977. Department of
Energy, Washington. D.C (1977).
IB. Pohl-Ruling, J.. Fischer, P.. and Pohl, E.
The Low-Level Shape of Dose Response for
Chromosome Aberrations, IAEA-SM-224/
403. Presented at International Symposium on
the Late Biological Effects of Ionizing
Radiation, IAEA, Vienna (1978).
19. Awa, A. A., et al. Relationship Between
Dose and Chromosome Aberrations in
Atomic Bomb Survivors, Hiroshima and
Nagasaki, RERF TR 12-77, Radiation Effect*
Research Foundation, Japan (1978).
20. Evans, R J., Buckton K. E., Hamilton, G.
E.. and Carothers A. Radiation-Induced
Chromosome Aberrations in Nuclear-
Dockyard Workers, Nature 227:531 (February
15,1979).
Appendix D—Summary of Evidence of
Significant Public Exposure to
Radinonuclides Because of Emissions
Into the Atmosphere
Most of the radionuclides in the
atmosphere come from natural sources
(1). However, radionuclides are used or
produced in thousands of locations
V-Radionuclides-3
-------
Rognster / Vol. 44, No. .249 / Thursday, December 27. 1978 / Moticeo
throughout the United States including
national defense weaponry facilities,
nuclear power plants, industrial plants,
research and development laboratories,
and medical facilities. Fossil fuel
combustion processes, such as large
cool-fire boilers, make some
contribution to the exposure of the
general public. Certain kinds of mining
and milling also substantially increase
the local concentration of radionudides
in the air.
usually used in these facilities, some
radionuclides are still released into the
atmoshphere and can disperse into
populated areas. In most cases the
greatest danger comes from breathing
these radionuclides, but material which
settles on soil or plants may eventually
be swallowed. Settled material may also
be blown back into the air. People living
near some facilities may also be
exposed to small levels of direct gamma
radiation from airborne or settled
radionuclides.
EPA has recently published a
preliminary evaluation of the harm
caused by emissions of radionuclides
into air in the United States (2). The
document contains a compilation of the
amount of radionuclides released into
the atmosphere from each major
category of facility known to use such
materials. It estimates both the radiation
dose to the nearest individual and to the
regional population. Using these doses,
we have estimated the additional •
lifetime fatal cancer risk to individuals
and the total number of fatal cancers
induced in the surrounding population
for each year of facility operation. Risk
estimates are limited to fatal cancers
because we have less confidence in
quantitative risk estimates of genetic
effects in humans. Our current practice
is to assume that for whold body
exposure, the number of genetic health
effects, and the number of nonfatal
cancers are each about the same as the
number of deaths (3).
Sources can be conveniently divided
into three major groups: facilities
licensed by NRG and certain States
which have signed an agreement with
NRC; facilities operated and regulated
by the Department of Energy (DOE); and
facilities emitting elevated
concentrations of naturally-occurring
radionuclides. The kinds of radionuclide
emissions, estimates of dose rates, and
estimates of fatal cancer risks derived
from model facilities which are
representative of source categories are
shown in Tables 1 and 2. Table 3 shows
data derived from actual DOE facilities.
These summary tables show that
significant amounts of radionuclides are
being releaesd by maa into the
atmosphere. Such estimates shoulld be
used carefuly and with recognition that
they are highly uncertain. This
uncertainty is caused by limited date on
emissions and by the use of assumptions
in environmental transport models and
in dose models, Based on these
calculations, the highest estimated doses
received are to people near elemental
phosphorus plants. Our preliminary
dose estimates for such people give iSOO
mrem/yr to She kidney, 74O mrem/yr So
the lung, and 570 mrem/yr to the bone.
People living near underground uranium
mines may be exposed to elevated
airborne concentrations of radon
daughters as high as O.CC3 working
levels. (WL).
We estimate that even the individuals
who live closest to the facilities listed in
Tables 1,2, and S receive doses which
are less than the present applicable
Federal Guidance as established by the
former Federal Radiation Council (6,5).
However, EPA considers the potential
risk from doses as large as those
received from many of these facilities to
be unnecessarily high. We believe that
emissions from such facilities should be
reduced to as low as reasonably
achievable levels. In specific cases, EPA
has already promulgated standards and
proposed Federal Guidance which holds
the exposure of people to levels below
that found around many of the listed
source categories. These actions include:
Drinking Water Regulations
(Radionuclides) (6), Environmental
Radiation Protection Standards for
Nuclear Power Operations (7), and
proposed Federal Guidance for Persons
Exposed to Transuranium Elements in
the Environment (8).
EPA considers its current estimates of
risk to be sufficiently accurate to
support the decision to list radionuclides
as hazardous air pollutants. However,
we will continue to improve our
preliminary estimates of how much
cancer is caused by facilities which
release radionuclides into the air.
As provided in EPA's recently
published proposed rules for regulating
airborne carcinogens (44 F.R. 58642-
58670; October 10,1979), EPA will base
all decisions on setting standards for
radionuclide emissions on detailed risk
assessments and complete regulatory
options analyses considering the
following factors: a detailed
examination of sources of emissions of
radionuclides into air, the risks caused
by these emissions, the costs and
effectiveness of emission control
technologies, the benefits of the
activities causing the emissions, the
relationoyps fostwosn who io rocsiviag
She benefits versus who is required to
accept the risks, and the possibility of
using substitutes to reduce emissions.
EPA will request public comment before
making Qtandard-oetting decisions.
S. United Nationo Scientific Commlttea on
the Effects of Atomic Radiation (UNSCEAR).
Sources and Offsets of Ionizing Radiation.
United Nationo, New York (1077).
2. United Stated Environmental Protection
Agency. Radiological Impact Caused by
ISmieeions of Radionuclidea into Air in the
United States--Preliminary Report (EPA 520/
7-78-003) Office of Radiation Programs,
Washington, D.C. (1678).
3. U.S. Environmental Protection Agency.
Radiological Quality of the Environment in
the United States, *P77(EPA 520/1-77-009).
Office of Radiation Programs, Washington,
D.C. (1877).
C. Federal Radiation Council. Background
Material for the Development oj Radiation
Protection Standards (Report No. 1).
Reprinted by the U.S. Deportment of Health,
Education, and Welfare, Public Health
Service, Washington. D.C. (May 13,1880).
5. Federal Radiation Council. Background
Material for the Development of Radiation
Protection Standards (Report No. 2).
Reprinted by the U.S. Department of Health,
Education, and Welfare, Public Health
Service, Washington, D.C. (September 1681).
6. Federal Hegisto, Vol. €1, No. 133, pp.
28402-09 (Friday, July 9,1978).
7. Federal Register, Vol. 42. No. 9, pp. 2858-
61 (Thursday. January 13.1977).
B. FesSaral Hegiodo?, Vol. 42. No. 230, pp.
60956-59 (Wedneoday. November 30,1977).
V-Rad ionuc1ide s -4
-------
Table 1
Summary of radiological impact caused by atmospheric emissions frcra licensed3 sources
I
JO
H-
o
3
d
o
0>
W
I
Ul
Source Number
category of
sources
Uranium conversion
facilities 2
Fuel fabrication 16
facility
Light water reactors
Boiling water
reactors 25
Pressurized water
reactors 14
High temperature gas
cooled reactor
(Fort St. Vrain) 1
Badiopharmaceutlcal
industry
Producers 3^
Principal
radionucllde emissions
(Ci/y)
U-23B
U-23',
Th-231*
U-23M
U-23.
U-23<>
U-238
Th-231
Th-23«
Noble
gases
Tritium
Halogens
Noble
gases
Tritium
Halogens
Nob l.i
gases
1-125
1-131
0.08
0.08
0.08
0.008
0.0003
0.0001)
0.001
0.0003
0.001
7,000
13
1.4
13,000
1,100
0.05
1,100
0.9
0.9
Model facility
Principal
dose equivalent rates
Maximum Regional Lifetime risk to the
Individual Population maximum individual
(mrem/y)b (Person-rem/y)° (x 10~6)
Lung 88 120 300
Bone 9 5
Lung 57 20
Bone 0.5 0.3
Thyroid 11 19 20
Whole body 2 8
Thyroid 17 9
Whole body 0.8 5
Whole body 0.5 6 6
Thyroid 86 200 3
Whole body 0.2 0.7
Expected fatal cancers
per year of operation
Regional population
(Fatal cancers)
0.007
0.0001
do. 001
OO.QOI
0.001
0.0003
s.
0?
3
o
o
a
CB
8
e
2
i
See footnotes at end of table.
-------
H-
O
O
(D
CO
I
CTi
.'able 1--continued
Summary of radiological impact caused by atmospheric emissions from licensed* sources
Model facility
Source
category
Principal
dose equivalent rates Expected fatal cancers
Number Principal Maximum Regional Lifetime risk to the per year of operation
of radlonuclide emissions Individual Population maximum individual Regional population
sources (Ci/y) (mrem/y)13 (Peraon-rem/y)° (x 10"^) (Fatal cancers)
Test reactors
Research reactors
University reactors
Shallow land burial
Low level waste
Industrial users
aSources licensed
regulatory authority
^Toe max in, urn dose
2 Ar-4l 150 Whole body 0.2 1 2 0.0002
Tritljm 150
13 Ar-ill 200 Whole body 0.09 0.5 1 0.00008
Tritium 100
51 Ar-11 1,000 Whole body 0.1 2 5 0.0001
Tritium 100
6 Tritium 19,000 Bone 30 6 90 0.0008
Whole body 20 5
1,000 Mostly No data
sealed
by the Nuclear Regulatory Commission (NRC) or States which have entered into an agreecer.t with the NRC whereby certain
is relinquished by the NRC and assumed by the States pursuant to Section 271 of the Atomic Energy Act of 1951, as amended.
equivalent rate an individual is likely to receive living near the facility.
cThe maximum collective dose equivalent rate to the regional population. This is the maximum value expected to occur within 100 years
following the start
of facility operation.
dThe number of fatal cancers to the worldwide population has been estimated to be 0.01 from BWRs and 0.02 from PWRs per year (2).
3?
O-
O
B.
&
•
a
n
o
n
(0
*-i
VI
^
(O
2
o
c.
n
(0
OD
-------
Table 2
Suinnary of radiological impact caused by atmospheric emissions of natural radioactive materials
Model facility
1
DJ
H-
3
C
O
I—1
H.
(D
CO
1
Source Number of
category sources
Uranium Mines
Underground 251
Open pit 36
Uranium Mills 21
Phosphate Industry
Mining and
beneficiation 35
Drying and grinding
facilities 20
Phosphoric
acid 35
plant
Elemental
phosphorus 9
plant
Coal-fired
power stations'* 395
Urban site
Suburban site
Rural site
Remote site
Exposure levels
Principal Maximum Regional
radionuolido emissions individual Population
(Cl/y)a (WL) (Person-WL)
Rn-222
Rn-222
Rn-222
U-21 )+d
Rn-222
Rn-222
U-?i8+d
Rn-222
U-239td
fin*-- •- c.
U**2_iO +d
Po-210
Rn-222
U-238+d
Th-.?32+d
Rn-222
U-238+d
Th-232+d
Rn-222
U-233+d
Th-232*d
Rn-222
H-.^'tfl < ii
Th-232»d
6800 0.006 1.3
2000 0.00084 0.38
2700 0.0049 0.54
0.4
1300 0.00022 4.9
20 0.00005 0.084
0.03
480 0.00066 2.0
0.1
490 0.00035 2.0
0.07
7.4.
1.9 0.00001 0.024
0.25
0.07
1.9 0.00001 0.002
0.25
0.07
1.9 0.00001 0.0005
0.25
0.0?
1.9 0.00001 0.00001
O.?rj
0.07
dose
Expected fatal
Principal Lifetime cancers per year
equivalent rates risk to the of operation
Maximum Regional maximum Population
Individual Population individual Regional U.S.
(mrem/y)b (Person-rem/y)0 (x 10~6) (Fatal cancers)
Lung
Bone
Lung
Bone
Lung
Bone
Lung
Bone
Kidney
Lung
Bone
Lung
Bone
Lung
Bone
Lung
Bono
-
-
350
360
-
54
79
85
110
740
570
1800
0.88
1.6
1.1
2.1
2.1
16.0
0.79
2.1
10,000 0.03 0.08
1,000 0.008 0.02
3.4 10,000 0.01 0.03
3.9
300 0.1
17 500 0.004
IS
46 2,000 0.05
45
770 6,000 0.1
440
1400
2600 10 0.2
1300
190 10 0.02
160
51 60 0.005
50
0.5 10 0.00008
1.5
ice looinolea at end ortaole.
-------
H-
O
O
(-1
H-
a.
a>
w
i
00
Summary of radiological
Table 2— continued
impact caused by atmospheric emissions of natural radioactive materials
Model facility
Principal
Source Nuir.btr of radionuclide emissions
category sources (Ci/y)a
Metal mining and 177 Rn-222 30 to
milling6 3000
Ncimet.il mining
and millingf 1,200 Rn-222 0.2 to
18
Underground drinking
water treatment
pliints 10,000 Rn-222 3-1
Expected fatal
Principal Lifetime cancers per year
Exposure levels dose equivalent rates risk to the of operation
Maximum fu-gional Maximum Regional tcaximunj Population
individual Population Individual Population individual Regional U.S.
(WL) (Pcrson-WL) (mrera/y)b (Person-rera/y )° (x 10-6) (Fatal cancers)
< 0.00001 to 0.005 to 20 to 0.0001 to
0.0006 0.8 900 0.02
< 0.00001 to 0.0007 to 0.7 to 0.00002 to
0.00001 0.06 50 0.001
< 0.00001 0.06 10 0.001
al)-233+d includes daughter products of uraniuro-231 , thoriuro-230, radium-226, poloniura-210 , and iead-210 except for elemental phosphorus '
plants wl:en poloniu.Ti-2'"1 is not included among the
thoriura-223, and radiun-,-22M .
''The maximum dose equivalent rate an individual
cThe maximum collective doau equivalent rate to
following the start of facility operation.
uraniuai-238 daughter products. Thoriuoi-232->1 includes the daughter products of radlum-228,
is likely to receive living near the facility.
the regional population. This is the ciaxiraum value expected to occur within 100 years
dT)-.e emission rates presented for the source category are based on a model representative of new plants releasing one percent of the fly ash.
elncludes iron, copper, zinc, and bauxite.
flncludes clay, limestone, fluorspar.
3?
c.
CD
sl
I.
K"
s
-------
T; ble 3
Summary of radiological Impact caused by atmospheric emissions from Department of Energy facilities
H-
o
3
C
O
M
H-
a
(D
w
I
Principal
dose equivalent rates3
Number
Facility of
facilities
Savjnnnh River
Plant6 1
Los Alr.mos 1
Scientific Laboratory
Lawrence Llvernore
Laboratory 1
Rocky Plata Plant 1
Argonne National
Lnbcrjtory 1
Brockhjvon National
Laboratory 1
Principal
radlonuclide
(Ci/y)
Ar-'il
C-l1)
Tritium
Kr-85
Ar-*41
C-ll
TritiL.,n
N-13
0-15
Ar-'ll
Tritium
N-13
0-15
Pu-?3') &
Pu-2'lO
U-235
U-238
Ar-11
Tritium
Ar-»41
Tritium
0-15
emissions
6'3,noo
t'3
360,000
lJ'10,000
800
1 '1,000
39,000
1.MOO
32,000
3bo
5,:oo
590
390
0.0000014
0.00002
0.00002
30,000
6'30
360
1,200
67,000
Maximum
Individual
(mrcm/y)
Total body 1.1
Total body 70
Total body <4.
Lung 0.
Bone 0.
Kidney 0.
Liver 0.
Total body 5.
Total body 0.
Regional
Population
(Person-rem/y)
110
11
3 2.9
03 130
035 58
004 7
005 9
6 180
16 19
Lifetime risk to the
maximum Individual
(x 10~6)
Site boundary 20
Site boundary 1,000
Nearest resident 300
Site boundary 60
Nearest resident 10
Site boundary 0.3
Site boundary 80
Nearest resident ^0
Site boundary 2
Expected fatal cancers
per year of operation
Regional population
(Fatal cancers)
0.02
0.002
0.0006
0.007
O.OM
O.OQ14
See footnotes at end of table.
-------
Table 3—continued
Summary of radiological impact caused by atmospheric emissions from Department of Energy facilities—continued
<
1
H-
0
c
o
H-
CD
W
1
M
O
Number
Facility of
facilities
Oak Ridge
Facilities0 1
Portsmouth Gaseous 1
Diffusion Plant0
Paducah Gaseous
Diffusion Plant0 1
Ames Laboratory 1
Other sites 17
Principal
radionucllde
(Ci/y)
0-251
1-131
Kr-65
Th-231
U-2'J1
Tc-i<9
U-231
U-238
Ar-11
Tritium
Various
emissions
0.06
1.1
8,600
0.05
0.1
1.5
0.2
0.2
13,000
1,000
Small
Principal
dose equivalent rates3
Maximum Regional Lifetime risk to the
Individual Population maximum individual
(mrem/y) (Person-rem/y) (x 10~*>)
Lung 1.6 Total body 1.7 Nearest resident 10
Bone 5.5
Thyroid 1.5
Lung 1.1 Total body 0.19 Site boundary 10
Bone 1.2
Kidney 1.1
G. I. Tract 2.2
Lung 6.3 NR Site boundary 20
Bone 0.9
Total body 5.5 250 Site boundary 80
Total body<1 Total body <10 Site boundary <10
Expected fatal cancers
per year of operation
Regional population
(Fatal cancers)
0.001
0.00001
NR
0.05
< 0.002
BData taken directly from DOE reports.
''All doses are 70-year dose commitments.
CA11 doses are 50-year dose commitments.
NR Not reported.
-------
TECHNICAL REPORT DATA
(/'lease read Instructions on the reverse before completing)
1. REPORT NO.
EPA-340/1-80-006
4. TITLE AND SUBTITLE
National Emission Standards for Hazardous Air
Pollutants: A Compilation as of May 1, 1980
3. RECIPIENT'S ACCESSION NO.
5. REPORT DATE
May 1. 1980
6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
8. PERFORMING ORGANIZATION REPORT NO.
P/N 3570-3-S
9. PERFORMING ORGANIZATION NAME AND ADDRESS
PEDCo Environmental, Inc.
11499 Chester Road
Cincinnati, Ohio 45246
10. PROGRAM ELEMENT NO.
68-01-4147, T.O. 136
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
U.S. Environmental Protection Agency
Division of Stationary Source Enforcement
Washington, D.C. 20460
13. TYPE OF REPORT AND PCDIQD COVERED
Supplement: Apr. 1979rMav.198Q
14. SPONSORING AGENCY CODE
15. SUPPLEMENTARY NOTES
DSSE Project Officer:
Kirk E. Foster, MD-7, Research Triangle Park. NC 27711
(919) 541-4571
16. ABSTRACT
Since their inception of 1971, the National Emission Standards for Hazardous Air
Pollutants (NESHAP) have been expanded and/or revised 54 times. In 1979 a compila-
tion of the NESHAPS (EPA-340/1 -79-006) was prepared to serve as a convenient
reference and source of information to those working with the regulations. This
document contains those pages necessary to update that publication through May 1,
1980. It is only an update and must be used in conjunction with the original
compilation.
Included in this supplement, with complete instructions for filing, are: a new
cover and title page; all revised NESHAP regulations; the full text of all re-
visions promulgated since April 1979; and all proposed standards or revisions.
17.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b.IDENTIFIERS/OPEN ENDED TERMS C. COS AT I Field/Group
Air Pollution
Emission Standards
Federal Regulations
National Emission
Standards for Haz-
ardous Air Pollutants
13B
18. DISTRIBUTION STATEMENT
Unlimited
19. SECURITY CLASS (ThisReport)
Unclassified
21. NO. OF PAGES
88
20. SECURITY CLASS (Thispage)
Unclassified
22. PRICE
EPA Form 2220-1 (9-73)
------- |