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An environmental protection publication in the solid waste management
series (SW-171). Mention of commercial products does not constitute
endorsement by the U.S. Government. Editing and technical content of
this report were the responsibilities of the Hazardous Waste Manage-
ment Division of the Office of Solid Waste Management Programs.
Single copies of this publication are available from Solid Waste
Information, U.S. Environmental Protection Agency, Cincinnati, Ohio
45268.
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A SUMMARY OF
HAZARDOUS SUBSTANCE CLASSIFICATION SYSTEMS
This report (SW-171) was written for the
Office of Solid Waste Management Programs
by Allen M. Kbhan
U.S. ENVIRDNMENTAL PROTECTION AGENCY
1975
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Contents
PAGE
I. Introduction and Summary 1
H. Consumer Product Safety Commission 6
TITLE 16, (CCMyERCIAL PRACTICES) , CFR, PART 1500 6
III. Department of Transportation 10
TITLE 49, (TRANSPORTATION), CFR, PARTS 100-199 10
U.S. COASTGUARD 12
NATIONAL ACADEMY OF SCIENCES REPORT , 13
3V. Department of Health, Education, and Welfare 17
FEDERAL FOOD, DRUG, AND COSMETIC ACT 17
NATIONAL INSTITUTE OF OCCUPATIONAL SAFETY AND Health (NIOSH) 18
Toxic Substances List 18
Priority list 21
NATIONAL CANCER INSTITUTE 23
V. Environmental Protection Agency 24
PESTICIDE PROGRAMS, (TITLE 40, CFR, PART 162) 24
OCEAN DUMPING, (TITLE 40, CFR, PART 227) 25
DRINKING WATER STANDARDS 27
FEDERAL WATER POLLUTION, CONTROL ACT, AS AMENDED 30
Sec. 304 (a) (1) - Water Quality Criteria 30
Sec. 307(a) - Toxic Pollutant List 33
Sec. 311 (b) (2) (A) - Hazardous Substance Spills 34
CLEAN AIR ACT - SEC. 112 36
SEWAGE SLUDGE WORKING GROUP 37
TRW SYSTEMS GROUP REPORT 37
BATTELLE MEMORIAL INSTITUTE REPORT 42
BCOZ-ALLEN APPLIED RESEARCH, INC. REPORT 46
VI. Department of Defense 50
DEPARTMENT OF THE ARMY 50
DEPARTMENT OF THE NAVY 50
VI. State Regulations 52
CALIFORNIA STATE LIST 52
VII. References 53
IX. Appendix 54
iii
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INTROXJCTICN AND SUMMARY
This paper describes the criteria used by 23 systems to define
a "hazardous substance," primarily for regulatory purposes. The predominance
of Federal systems is explained by the number of Federal statutes mandating
regulation of hazardous substances in food, in transport, in the work place,
and in the air and water environment. In addition, the supply component of
the military services uses hazard ratings to help determine precautions
needed for storage and shipment of materials. Only the State of California
system has been developed for the purpose of comprehensively managing
hazardous wastes, including their transport and disposal.
The set of criteria used by each of the hazardous substance classifica-
tion systems is shown in Table A - Classification Criteria. The only systems
not shown in this table are the NIOSH priority list, and the systems of the
EPA Sewage Sludge Working Group and the U.S. Coast Guard. The priority list
had no criteria that could be categorized, the working group is still drafting
guidelines for heavy metal content in sewage sludge, and the Coast Guard
regulations are essentially identical to Title 49, Code of Federal Regulations
(CFR), Parts 100-199.
Every classification system studied uses toxicological criteria in
determining whether a substance should be classified as hazardous. Many
systems utilize the toxicology criterion as the primary screen for identifying
hazardous substances, although their focus is on acute rather than chronic
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TABLE A - CLASSIFICATION CRITERIA
Criteria
System
Title 15, U.S. Code, Sec. 1261
CPSC-Title 16, CFR, Part 1500
Food, Drug, and Cosmetic Act
DOT-Title 49, CFR, Parts 100-199
Pesticides-Title 40, CFR, Part 162
Ocean Dumping-Title 40, CFR, Part 227
NIOSH-Toxic Substances list
Drinking Water Standards
FWPCA Sec. 304 (a) (1)
Sec. 307 (a)
Sec. 311 (b)(2)(A)
Clean Air Act-Sec. 112
California State List
National Academy of Sciences
TRW Systems Group
Batelle Memorial Institute
Booz-Allen Applied Research, Inc.
Dept. of the Army
Dept. of the Navy
National Cancer institute
Toxicological
X
x
X
X
X
X
X
X
x
X
X
X
X
X
y
X
X
X
X
x
Flammability
X
x
X
x
x
X
x
X
X
T
A
Explosive
X
Y,
y
X
X
X
Corrosive
X
Y
X
x
Y
X
Reactivity
X
X
X
X
Oxidizing 1
material
X
X
X
Radioactive
X
x
X
x
X
X
Irritant
X
x
X
x
y
X
1
x
x
X
— g
•r
(E
x
X
x
x
x
x
X
X
Y
fel
H
X
X
X
X
X
X
X
x
X
x
1 Sufficient
| quantity
X
y
x
x
X
X
X
X
X
X
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toxicity data. Acute toxicity data are more extensive than chronic toxicity
data, and the results are more clear-cut (i.e., death versus some level of
bodily impairment). The acute toxicity tests most frequently used in these
systems are the lethal doses of a substance administered orally and dermally,
and the lethal concentration of a substance administered by inhalation.
Other acute toxicity tests included the concentration of a substance
lethal to aquatic life or causing a decrease in aquatic flora. One chronic
toxicity criterion used in several systems was the Threshold Limit Value
(TLV) of a substance, (see discussion of TRW Systems Group).
The acute toxicity levels and flammability criteria utilized by
different systems for classifying substances as hazardous are depicted in
Table B. The Federal Hazardous Substances labeling Act, (Title 15, U.S. Code,
Sec. 1261), provided the definition of "highly toxic" substances that was
subsequently incorporated into many classification systems.
This Act's definitions of "flammable" and "extremely flammable" substances
were also incorporated into other classification systems, although these criteria
were not as widely adopted as the "highly toxic" criterion. (The "combustible"
classification shown in Table B, did not appear in the original act.)
Other classification criteria are not as similar among systems as the
toxicological or flammability criteria. The source of each system's classifica-
tion criteria is noted, if available. The "sufficient quantity" criterion is
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TABLE B - ACUTE TOXICITY AND FLAMMABILITY CRITERIA
FLAMMABILITY-41'
HIGHLY TOXIC SUBSTAF'CES'
SYSTEM
Title 15, USC., Sec. 1261
CPSC-Title 16, CFR,
Part 1500
DOT Title 49, CFR,
Parts 100-199
Pesticides-Title 40,
- CFR, Part 162
NIOSH-Toxic Substances
List
FWPCA-Sec. 307 (a)***
Sec. 311 (b) (2) (A)
California State List
National Academy of
Sciences
Battelle Memorial
Institute
Booz-Allen Applied
Research, Inc:
ORAL
LD50
mg/kg
50
50
50
50
5,000**
50
50
50
tl
50
50
50
INHALATION
LC5Q
(dust or mist) (gas or
micrograms vapor)
per liter ppm
2,000
2,000
2,000
2,000
2,000**
2,000
2,000
2,000
2,000
5, 000 (man)
2,000(ecology)
200
200
200
200
200
200
200
50
to
200
200
DERMAL
LD50
mg/kg
200
200
200
200
2,800**
200
200
200
20
to
200
200
AQUATIC LIFE
LC50
mg/l
10
500
1
1,000
100
AQUATIC FLORA
ppm
100
1,000
EXTREMELY
Flammable
FpS 20°F
Fpi 20°F
^200F*
Fp-c 200F
Fp^ 100°F
BpS 100°F
BpS 100°F
i
HIGHLY
FLAMMABLE
F<1000F
Bp>100°F
FLAMMABLE
2GUF«=
^C ROT*1
Fp-580°F
F-1000F
20°F-c *
F < 80°F
*5s8b°F
COMBUSTIBLE
80°F-Fp<150o
Fp-^ 1SO.*F
100°F <
Fp-£:2000F
"fOral LI)5Q, Inhalation LC5Q, Dermal LDjQ are defined in Federal Hazardous Substances Labeling Act section; aquatic life LCjQ and aquatic flora
IIjm are defined in sections dealing with Sec. 307(a) and Sec. 311(b)(2)(A) of FWPCA, respectively. Unless otherwise indicated, substances
having toxicities less than or equal to the amount indicated are classified as highly toxic
=^F_: flash point; Bp: boiling point
*Proposed standard
**LCLo, LC5Q, LDLo, or LDjQ: no tine limit for tests given, see NIOSH section.
***Currently under revision.
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often an exemption for very small amounts or packages of a substance, i.e.,
too small for a label. Such exemptions are included in Title 15, U.S. Code,
Sec. 1261, and CPSC and DOT regulations. In other cases, the quantity of a
substance produced or discharged is a criterion considered when classifying
substances (e.g., TRW Systems Group and Booz-Allen Applied Research, Inc.),
or designating a substance as hazardous for purposes of regulation (e.g.,
Sec. 307 (a) and Sec. 311 (b) (2) (A) of the FWPCA).
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CONSUMER PRODUCT SAFETY COMMISSION
Title 16, (Conmercial Practices), CFR, Part 1500
Section 30 (a) of the Consurter Product Safety Act (P.L. 92-573) vests
authority granted under the Federal Hazardous Substances Labeling Act (P.L.
86-613, enacted July 12, 1960) in the Consumer Product Safety Commission.
The Commission is therefore responsible for enforcement of labeling require-
ments governing hazardous substances intended or packaged in a form suitable
for use in the household. (Exemptions to such requirements are allowed for
food, drugs, cosmetics, fuels, small packages, minor hazards, and special
circumstances.)
The Federal Hazardous Substances Labeling Act (referred to as "the Act")
defines a "hazardous substance" as:
any substance or mixture of substances which (i) is toxic,
(ii) is corrosive, (iii) is an irritant, (iv) is a strong
sensitizer, (v) is flammable, or (vi) generates pressure
through decomposition, heat, or other means, if such
substance or mixture of substances may cause substantial
personal injury or substantial illness during or as
proximate result of any customary or reasonably foresee-
able ingestion by children.
The term "toxic" is applied to any substance (other than a radioactive
substance) which has the capacity to produce personal injury or illness to
man through ingestion, inhalation, or absorption through any body surface.
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The term "highly toxic" is defined as:
any substance which falls within any of the following
categories: (a) Produces death within fourteen days
in half or more than half of a group of ten or more
laboratory white rats each weighing between two
hundred and three hundred grams, at a single dose of
fifty milligrams or less per kilogram of body weight
when orally administered, (oral IDso ); or (b) produces
death within fourteen days in half or more than half
or a group of ten or more laboratory white rats each
weighing between two hundred grams, when inhaled con-
tinuously for a period of one hour or less at an at-
mospheric concentration of tsro hundred parts per
million, (ppm), by volume or less of gas or vapor or
two milligrams per liter by volume or less of mist
or dust, provided such concentration is likely to be
encountered by man when the substance is used in any
reasonably foreseeable manner, (inhalation LC50 );
or (c) produces death within fourteen days in half
or more than half of a group of ten or more rabbits
tested in a dosage of two hundred milligrams or less
per kilogram of body weight, when administered by
continuous contact with the bare skin for twenty-
four hours or less, (dermal H>so ) •
The term "corrosive" means any substance which in contact with living
tissue will cause destruction of tissue by chemical action; such term shall
not refer to action on inanimate surfaces. The term "irritant" means any
substance not corrosive which in immediate, prolonged, or repeated contact
with normal living tissue will induce a local inflammatory reaction.
The term "strong sensitizer" means:
a substance which will cause on normal living tissue
through an allergic or photodynamic process a
hypersensitivity which becomes evident on reapplica-
tion of the same substance, and which is designated
as such by the Commission. Before designating any
substance as a strong sensitizer, the Commission
upon consideration of the frequency of occurrence
and severity of the reaction, shall find that the
substance has a significant potential for causing
hypersensitivity.
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The term "extremely flammable" shall apply to any substance which has
a flash point at or below 20 F as determined by the Tagliabue Open Cup
Itester, and the term "flammable" shall apply to any substance which has
a flash point above 20 F, to and including 80 F, as determined by the same
test.
These hazardous substance definitions are incorporated into Sec. 1261
of Title 15 (Ccrarerce and Trade) of the U.S. Code. The only difference
noted between the hazardous substance definitions found in the code and in
the Act was the inclusion in the former of a "combustible" category for
those substances with flash points greater than 80 F, but less than or
equal to 150 F.
Title 16 (Commercial Practices), CFR, Part 1500.3 contains the following
items which interpret, supplement, or provide alternatives to the afore-
mentioned hazardous substance definitions, (which are also contained in this
Part):
"Toxic substances" are defined as those substances falling within any of
the following categories:
(1) Any substance having an oral IDso of more than
50 mg/kg but not more than 5 g/kg of body
weight. Substances falling in the toxicity
range between 500 mg and 5 grains per kilogram
or body weight will be considered for exemp-
tion from some or all of the labeling require-
ments;
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(2) Any substance having an inhalation LCso of more
than 200 ppm but not more than 20,000 ppm by
volume of gas or a vapor or more than 2 mg but
not more than 200 mg per liter by volume of
mist or dust; or
(3) Any substance having a dermal H>50 of more than
200 mg/kg of body weight but not more than 2
g/kg of body weight.
"Irritants" are subdivided into "primary irritants to the skin" and eye
irritants. Primary irritants are substances that are not corrosive and result
in an empirical score of five or more when tested by the method described in
Sec. 1500.41. Eye irritants are defined as those substances giving a positive
test result when the test method described in Sec. 1500.42 is used.
"Extremely flammable solid" means a solid substance that ignites and
burns at an ambient temperature of 80 F or less when subjected to friction,
percussion or electrical spark. "Flammable solid" means a solid substance
that when tested by the method described in Sec. 1500.44, ignites and burns
with a self-sustained flame at a rate greater than one-tenth of an inch per
second along its major axis.
A susbtance is considered "corrosive" to the skin, if when tested by the
technique described in Sec. 1500.41, the structure of the tissue at the site
of contact is destroyed or changed irreversibly in 24 hours or less. Criteria
for determining whether a substance is hazardous because it generates pressure
through decomposition, heat, or other means are also listed.
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DEPARTMENT OF TRANSPORTATION
Title 49, (Trarisportation), CFR, Parts 100-199
Title 49, CFR, Parts 100-199 contain regulations covering the preparation
of hazardous materials, (including their loading and storage), for transpor-
tation by cannon carriers, rail freight, rail express, rail baggage, highway
or water. These regulations also cover construction containers, packaging,
weight, marking, labeling, billing, and shipper's certificate of compliance.
(Sec. 171.1(a)).
Section 173.2 lists the priority of hazards in the following order
(from highest to lowest priority):
(1) Radioactive material
(2) Flammable or nonflammable gas
(3) Extremely toxic liquid or solid
(4) Flammable liquid
(5) Oxidizing material
(6) Flammable Solid
(7) Corrosive material, (liquid)
(8) Highly toxic liquid or solid
(9) Irritating material
(10) Corrosive material, (solid)
(11) Combustible liquid
10
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Sec. 173.326 lists thirteen poisonous gases that qualify as extremely
dangerous poisons. The definition for less dangerous, liquid or solid poisons
is contained in Sec. 173.343. The oral, inhalation, and dermal toxicities of
a substance are used as criteria in determining this class of poisons. The
toxicity levels chosen were identical to the "highly toxic" category of
Title 15, U.S. Code, Sec. 1261.
Flammable and combustible liquids are defined in Sec. 173.115. Flammable
liquids are those liquids having a flash point below 100 F. Combustible
liquids are those liquids having a flash point above 100 F and below 200 F.
Flammable compressed gases are defined in Sec. 173.300 (b).
Explosives forbidden from transportation by common carriers by rail freight,
rail express or highway, or water are defined in Sec. 173.51. Sec, 173.52
categorizes explosives acceptable for transportation into three classes:
(1) Class A explosives; detonating or otherwise of maximum hazard, (defined in
Sec. 173.53); (2) Class B explosives; flammable hazard, (defined in Sec. 173.88);
and (3) Class C explosives, minimum hazard (defined in Sec. 173.100).
Oxidizing materials are defined (Sec. 173.151) as those substances that
yield oxygen readily, thereby stimulating the combustion of organic natter.
Corrosives are defined as in Title 21 (Food and Drugs), CFR, Sec. 191.1 and
tested by the method described in Sec. 191.11. A liquid is considered to have
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a severe corrosion rate if its corrosion rate exceeds 0.250 inches per year on
steel (SAE 1020) or aluminum (nonclad 1075^16) at a test temperature of 130 F,
(Sec. 173.240 of Title 49). An acceptable test is described in NACE Standard
1M-01-69.
Irritants, (defined in Sec. 173.381) are defined as those liquid or
solid substances which upon contact with fire or when exposed to air give
off dangerous or intensely irritating fumes, but not including any Class A,
extremely poisonous materials.
An "etiologic agent" (defined in Sec. 173.386) means a microorganism, or
its toxin which causes or may cause human disease and is limited to those
agents listed in Title 42 (Public Health), CFR, Sec. 72.25(c). Radioactive
materials are defined by fissile class and transport group in Sec. 173.389.
U.S. Coast Guard
Chapter I of Title 46 (Shipping), CFR, contains U.S. Coast Guard regulations
governing shipment of materials. Most of the hazardous materials regulations are
similar to those described in Title 49, Parts 100-199. One difference, however,
is that Sec. 146.27-1 describes a hazardous article, (other than an explosive,
inflammable liquid or solid, oxidizing material, corrosive liquid, compressed
gas, poisonous article or combustible liquid) as one which:
12
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(a) Is liable to spontaneous heating in excess of
10 F when subjected to a test of three
continuous hours in a Mackey apparatus at or
below a temperature of 212 F; or
(b) Tnberates vapor susceptible to ignition by
spark or open flame at or below a temperature
of 300 F.
National Academy of Sciences^-
Systems for Evaluation of the Hazards of Bulk Water
Transportation of Industrial Chemicals
This study classifies the hazards of bulk water transportation of
industrial chemicals in each of nine categories (see Table C - Summary of
Hazard Evaluation Criteria). The hazard rating of an industrial chemical
is evaluated independently for each category. Mb ranking of chemical
hazard by combining the category ratings into one overall figure can be
justified, however.
The fire hazard rating, Category 1, classifies those chemicals with
a flash point of less than 100 F and a boiling point of less than 100 F
as "extremely hazardous," while those chemicals with a flash point less
than 100 F and a boiling point greater than 100 F are classified as
"highly hazardous."
Categories II thru V are occupational health hazard ratings. The hazard
of liquid contact with skin and eyes is classified in Category II. Those
chemicals having a dermal ID50 of less than 20 mgAg are classified as
"extremely hazardous," while those chemicals with a 11)50 °^ Beater than
20 mgAg/ but not more than 200 mgAg/ are classified as "highly hazardous."
13
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G
R
A
D
E
II
III
IV
VI
VII
VIII
XI
FIRE
Insignif.
Hazard
Non-combust
Slightly
Hazardous
FPcc>140°F
(60°C)
Hazardous
FPcc
TOOCF-140°F
(37.8°-60°C)
Highly
Hazardous
(37.8°C)
FPcc<100°F
BP>100°F
(37.8°C)
Extremely
Hazardous
/•J7 O0r\
FPcc<100°F
BP<100°F
(37.8 C;
HEALTH
Skin and Vapor Gas Repeated
Eyes Inhalation Inhalation
Insignif.
Hazard
All not
described
Delow
Slightly
Hazardous
Corrosive
to eyes-
Moderately
Hazardous
Corrosive
to skin
Highly b
Hazardous
LD™
20:2COnig/kg
24 hr. skin
contact
Extremely
Hazardous
LDso < 20mg
24 hr. skin
contact
nsignif.
azard
11 not
escribed
elow
lightly
azardous
Depressants,
Asphyxiants
Moderately
Hazardous
LC50
200-2000 ppm
Highly J,
Hazardous
LC5Q 50-200ppm
or 0.5-2 mg/1
Extremely
Hazardous
LCSO^ 50ppm
or < 0.5 mg/1
Jot
\pplicable
All those
not
described
below
Moderately
Hazardous
LCso
200-2000ppm
Highly 1
Hazardous
LC5Q
50-200 ppm
Extremely
Hazardous
Lf5o<50ppm
Inhalation
Insignif.
Hazard
OSHA >
000 ppm
Slightly
Hazardous
SHA
00-1000 ppir
Moderately
Hazardous
OSHA
10-100 ppm
Highly
Hazardous
DSHA
1-10 ppm
Extremely
Hazardous
OSHA <1 ppm
WATER POLLUTION
Human Aquatic
Toxicity
Insignif.
Hazard
LD50>
5000 mg/kg
Slightly
Hazardous
LD50
500-5000mg/kg
Moderately
Hazardous
LD50
50-500/mg/kg
Highly ^
Hazardous
LD50
5-50 mg/kg
Extremely
Hazardous
LD5Q< 5 mg/kg
Toxicity
Insignif.
Hazard
Lm>1000mg/l
ractically
on toxic
Lm
100-1000 mg/1
lightly
'oxic
TLm
10-100 mg/1
Moderately ,
Toxic
TLm 1-10 mg/1
Highly Toxics
TLm
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The hazard rating for the short-term Inhalation of gas or vapor,
Categories III and IV, classifies those chemicals with an inhalation ICcg
of less than 50 ppm or less than 0.5 mg/1 as "extremely hazardous," while
those chemicals with a LC5Q of greater than 0.5 mg/1, but not more than
2 mg/1, are classified as "highly hazardous."
The hazard rating for repeated inhalation of gases and vapors,
Category V, is based on Title 29 (Labor), CFR, Sec. 1910.93. Those substances
listed in specified tables or regulated elsewhere in this section, having an
8-hour time weighted average exposure limit of less than 1 ppm are classified
as "extremely hazardous," while those substances having an exposure limit of
more than 1 ppm but not more than 10 ppm are classified as "highly hazardous."
Water pollution hazard ratijigs, Categories VT, and VTI, are concerned
with the toxicological dangers, to humans and to aquatic life, associated
with a chemical spilled or dumped into waterways. Those chemicals with
an oral LDcQ of less than 5 mg/kg are classified as "extremely hazardous,"
while those chemicals with oral LDso of more than 5 mg/kg i but not more
than 50 mg/kg, are classified as "highly hazardous." Substances having a
96-hour aquatic life LC50 (or median threshold limit, Tim ) of less than
1 mg/1 are classified as "highly toxic." These ratings do not address the
problem of bioaccumulation.
15
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Reactivity hazard ratings, Categories VIII and IX, are concerned with
the likelihood of chemical reaction with water, or chemical self-reaction,
usually via polymerization. The "extremely hazardous" water reaction hazard
rating is classified as a violent reaction of a chemical with an equal
weight of water in a tank at ambient temperature. The "highly hazardous"
rating is assigned to those chemicals that undergo a vigorous reaction with
water under similar conditions. Chemicals that can undergo self-oxidation,
and/or polymerization, possibly causing explosions or detonations, are
classified as "extremely hazardous." Chemicals that may undergo self-
reaction, and require special handling, such as incorporation of a stabilizer
or polymerization inhibitor, are classified as "highly hazardous."
16
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DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act mandates that any poisonous
or deleterious substance added to any food shall be deemed to be unsafe
in any quantity exceeding the limits fixed by the Secretary (of Health/
Education, and Welfare) as necessary for the protection of public health
(Sec. 406). Furthermore, under Sec. 408, those poisonous or deleterious
pesticide chemicals not generally recognized as safe for use shall not
exceed tolerance levels established by the Secretary with respect to use
in or on raw agricultural commodities.
Tolerance levels for poisonous or deleterious substances are
established on the basis of the best evidence currently available.
Determination of a "safe" no-effect level in food is made considering
toxicological studies, evidence of bioaccumulative properties, likelihood
of body retention of the substance, amount of food likely to be consumed,
and any other relevant factors.
Sec. 409 (c)(3)(A) stipulates that no food additive shall be deemed
to be safe if it is found to induce cancer when ingested by man or animal.
Thus, there are no "safe" no-effect levels for carcinogens. This provision
does not apply with respect to the use of a substance as an ingredient of
17
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feed for animals which are raised for food production if the Secretary of
Health^ Education, and Vfelfare finds that under specified conditions of
use and feeding the additive will not adversely affect the animals for which
the food is intended and that no residue of the additive will be found in
any edible portion of such animal after slaughter or in any food yielded by
or derived from the living animal.
National Institute of Occupational Safety and Health
Toxic Substances List. The National Institute of Occupational Safety and
Health (NIOSH) in compliance with Sec. 20 (a) (6) of the Occupational Safety
and Health Act of 1970, (P.L. 91-596), periodically publishes a toxic
substances list. Dosages differentiating relatively toxic and nontoxic
substances according to route of administration to experimental animals are
listed in Table D2 . The limiting dosages were chosen on the basis of avail-
able data and toxicological judgment^ .
The oral route of administration is the preferred testing method. This
method is the most widely used and documented. The inhalation and skin
absorption routes of administration are used in that order when data for oral
administration are not available2 .
The order of preferrence of test data by species is:
(1) Man (6) Cat
(2) Rat (7) Rabbit
(3) Mouse (8) Pig
18
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TABLE D
LIMITING DOSAGES DIFFERENTIATING RELATIVELY TOXIC AND NONTOXIC SUBSTANCES
ACCORDING TO ROUTE OF ADMINISTRATION TO EXPERIMENTAL ANIMALS
OF A MAXIMUM TOTAL (ACUTE)* DOSE CAUSING DEATH**
ROUTES OF ADMINISTRATION (with abbreviations)
SPECIES
(with
abbreviations)
Hamster (ham), Frog (frg),
Gerbil (grb)
Rat (rat), Mouse (mus),
Mammal, unspecified (mam)
Rabbit (rbt), Guinea Pig (gpg),
Chicken (ckn), Pigeon (pgn),
Quail, (qal),Duck (dck),
Turkey (trk), Bird (brd)
Dog (dog), Monkey (mky),
Cat (cat), Pig (pig), Cattle (ctl),
Domestic Animals: sheep,
goat, horse (dom)
Oral
f rti-l \
( on )
Rectal
(rec)
Intraduodenum
(idu)
Intracervix
(icv)
mg/kg
2,500
5,000***
1 0,000
10,000
Inhalation
(ihl)
24-Hour
Maximum
ppm mg/nr
5,000 1,000
(0.5%)
10,000 2,000
(1%)
20,000 4,000
(2%)
20,000 4,000
(2%)
Skin
(skn) .
Intrapentoneal
(ipr)
Intrapleural
(ipl)
mg/kg mg/kg
1,400 1,000
2,800 2,000
2,800*** 4,000
5,600 4,000
Parenteral
Subcutaneous
(scu)
Intradermal
(idr)
Implant
(imp)
mg/kg
5,000
10,000***
20,000
20,000
Intravenous (ivn) Other
Intramuscular (ims) (par)
Ocular (ocu)
Intracerebral (ice)
Intratracheal (itr)
Intraplacental (ipc)
Intravaginal (ivg)
Intrarenal (irn)
mg/kg mg/kg
750 1,000
1,500 2,000
3,000 4,000
3,000 4,000
Unreported
/ 1 . _ I. "i
(unk)
mg/kg
2,500
5,000
10,000
10,000
'Applies to those substances for which acute or short term toxicity characterizes the response, e.g., fast-acting substances, irritants, narcoses-producing substances and most
drugs. Does not apply to substances whose characteristic response results from prolonged exposures, e.g., silica, lead, benzene, carbon disulfide, carcinogens. Concentrations
more appropriately characterizing the toxicity of long- or slow-acting substances are derived from non-acute toxicity studies.
*'Calculated from experimental data (Stokinger).
•••From Hine and Jacobson, AIHAAP 15, 141, 54.
-------
(4) Dog (9) Guinea pig
(5) Monkey (10) Hamster
The limiting dosages shown in Table D for substances administered by
any route other than inhalation may be:
(1) LCLo: Lethal Dose Low - the lowest dose of a substance
(other than LD 50) introduced over any given period of
time, and reported to have caused death in man, or the
lowest single dose introduced in one or more divided
portions and reported to have caused death in animals; or
(2) LDsg: Lethal Dose Fifty - the dose of a substance
expected to cause death of 50% of an entire population
of an experimental animal species, as determined from the
exposure to the substance of a significant number from
that population. Other lethal dosages (LDio/ LDso) ' are
used in absence of an LDso, if available.
Limiting dosages for substance administered by inhalation may be:
(1) LCLo: Lethal Concentration Low - the lowest concentration
of a substance, other than an LCso in air, which has been
reported to have caused death in animals when they have
been exposed for 24 hours or less; or
(2) LCgQ: Lethal Concentration Fifty - the concentration of
a substance, in air, exposure to which for 24 hours or
less would cause the death of 50% of an entire population
of an experimental animal species, as determined from
exposure to the substance of a significant number from
that population.
In addition to toxic substances reported to have caused death in experi-
mental animals, the toxic substances list includes those substances reported
to have produced any toxic effect in man. There is no qualifying limitation
to the duration of exposure, nor to the quantity or concentration of the
substance, nor to the circumstances that resulted in the exposure. Also, the
20
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list includes those substances reported to have produced any carcinogenic,
teratogenic, mutagenic, or neoplastigenic effects in humans or animals.
Qualifying toxic effects for animal data include the production of tumors
(neoplastigenesis), whether benign or malignant (carcinogenesis), and the
production of changes in the offspring, whether transmissible (mutagenesis)
or not (teratogenesis). The reported effects may have been generated by
exposure to the substance over any period of time and in any quantity or
concentration of dose.
Priority List. NIOSH prepared another list, known as the priority list,
for the purpose of ranking substances that would subsequently have
occupational standards developed and recommended to the Occupational Safety
and Health Administration (OSHA). The ranking of substances on the priority
list was done by calculation of an overall rating. The overall rating was
derived by multiplying the number of workers exposed to a substance by a
severity rating. The severity rating was developed by a Delphi technique
in which a list of compounds was sent out to some 50 industrial hygienists
4
who rated the substances using a scale for relative severity . Criteria
documents were then developed for substances ranked highest on the priority
list.
Criteria documents present background information on chemical exposure
and morbidity. Evidence of the substance acting as a carcinogen, teratogen
or mutagen, or inducing respiratory, cardiac, or nerve disease in humans or
21
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animals is used in developing the recxranended standard. Though usually
there is extensive data on chemical exposure and morbidity, in most cases
few good correlations between exposure and morbidity can be inferred.
(See Appendix for listing of NIOSH recommended standards developed to data,
and those planned for development through fiscal year 1976.)
OSHA is responsible for the promulgation of occupational safety and health
standards. To data, criteria document development by NIOSH has resulted in the
promulgation of standards for only two substances — vinyl chloride and asbestos.
Many chemical substances, however, are currently listed in Tables G-l, G-2, or
G-3 of Sec. 1910.93 of Title 29 (Labor), CFR, and subject to regulations
described therein. Also, 14 substances are designated as carcinogens and subject
to regulations found in Sec. 1910.93c.
An employee's exposure to any material in Tables G-l or G-3, the name
of which is not preceded by "C", cannot exceed the 8-hour time weighted average,
the acceptable ceiling concentration, or the acceptable maximum peak above the
ceiling concentration for the given material. The acceptable maximum peak
concentration may never be exceeded, and exposure to concentrations greater
than the acceptable ceiling concentration cannot exceed the "maximum duration"
time period listed in the table. The source of standards found in this table
is the American National Standards Institute, 237 series.
Occupational health standards promulgated by OSHA for a given substance
supercede those restrictions found in the previously referenced tables.
22
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National Cancer Institute
The National Cancer Institute (NCI) is sponsoring a program to collect,
analyze, and systematize information in the chemical description, production,
distribution, and human exposure to carcinogenic chemicals which the public
may come into contact with in significant amounts . The program is designated
"A Research Program to Acquire and Analyze Information on Chemicals that Impact
on Man and His Environment." Criteria used by NCI's Chemical Selection Committee
for selecting chemicals for carcinogenic testing are:
1. The degree of overall exposure
2. Projected new or increased human exposure
3. Exposure of subpopulations important to society
4. Epidemiological clues (high cancer incidence
subpopulations)
5. Relation to known carcinogens
6. Gaps in knowledge
Collected data include such information as the quantity of chemicals
available for exposure, and the routes of exposure, i.e., oral, dermal,
respiratory, and peritoneal.
23
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ENVIRONMENTAL PROTECTION AGENCY
Office of Pesticide Programs
Title 40 (Protection of Environment), CFR, Part 162 contains regulations
for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide
Act (F3FRA), as amended. Sec. 162.8 lists the criteria for economic poisons
"highly toxic" to man. The oral, dermal, and inhalation toxicity levels used
to classify "highly toxic" poisons are identical to those listed in Table 15,
U.S. Code, 1261. The classification of economic poisons is done for labeling
purposes.
Proposed rulemaking to revise current procedures for the registration of
pesticides and establish procedures for the registration and classification
of pesticides to conform with the provisions of FIFRA, as amended, was
published in the Federal Register of October 16, 1974. Proposed Sec. 162.10
describes labeling requirements. Four toxicity categories are listed, with
Category I corresponding to the "highly toxic" classification under the
current definition of economic poisons. In addition to prescribed oral,
inhalation, and dermal toxicity levels, Toxicity Category I includes eye
effects and skin irritation criteria. If a substance causes irreversible
corneal capacity at seven days or severe skin irritation or damage at 72
hours, then it would be classified under Toxicity Category I.
The proposed rulemaking includes flanmability labeling requirements.
"Extremely flamnable" and "flammable1' categories correspond to those found
in Title 15, U.S. Code, Sec. 1261. Also, a "Caution" label is required for
24
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non-pressurized containers having a flash point above 80 F and not over
150 F.
Acting under authority of Sec. 3(c) (5) of FIFRA, as amended, the
Administrator proposes indices of presumptive refusal to register pesticides
(Sec. 162.11). These indices include both acute and chronic toxicity
criteria. "Use" classification criteria for newly and previously registered
pesticide products are proposed (also in Sec. 162.11) under authority of
Sec. 3(d) of FIFRA, as amended. Criteria for domestic, nondomestic, and
outdoor applications of pesticides are delineated. Classification criteria
for new pesticide registrations are generally less stringent than those for
previously registered products.
Ocean Dumping
Sec. 102(a) of the Marine Protection, Research, and Sanctuaries Act of
1972 (P. L. 92-532) authorizes the Administrator to establish criteria for
evaluating ocean dumping permit applications. Title 40, CFR, Part 227 is
concerned with criteria for the evaluation of permit applications. Sec.
227.22 (f) specifies that wastes with trace contaminants may be dumped under
special permit when the following limits are not exceeded:
(1) Mercury and its compounds are not present in any solid phase
of a waste in concentrations greater than .75 mgAg/ and the
total concentration of mercury in the liquid phase of a waste
does not exceed 1.5
25
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(2) Cadmium and its compounds are not present in any solid phase
of a waste in concentrations greater than .6 mg/kg/ and t*16
total concentration of cadmium in the liquid phase of a waste
does not exceed 3.0 mg/kg;
(3) Ihe total concentrations of organohalogens do not exceed the
limiting permissible concentrations of pollutants as defined
in Sec. 227.71;
(4) The total amounts of oil and greases do not produce a visible
surface sheen in an undisturbed water sample when added at a
rate of one part waste material to 100 parts of water.
Sec. 227.71 defines limiting permissible concentration as:
(a) that concentration of waste material or chemical constituent
in the receiving water which, after reasonable allowance for
initial mixing in the mixing zone will not exceed .01 of a
concentration shown to be toxic to appropriate sensitive
marine organisms in a bioassay carried out in accordance with
approved EPA procedures; or
(b) .01 of a concentration of a waste material or chemical consti-
tutent otherwise shown to be detrimental to the marine envrion-
ment.
The 96-hour median threshold value for aquatic life of a waste material or
chemical constituent is used in computation of the limiting permissbile
concentrations. Subsquent sections define the release and mixing zones.
The level of trace contaminants allowed in waste dumped under special
permit and the definition of limiting permissible concentrations were
derived from a working group's consensus judgment.
26
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Drinking Water Standards
The current drinking water standards were promulgated by the U.S. Public
Health Service in 1962. Proposed interim primary drinking water standards were
published in the Federal Register on March 14, 1975, pursuant to Sec. 1412(a)
of the Safe Drinking Water Act (P.L. 93-523). These standards will take
effect 18 months after the date of promulgation. The current and proposed
drinking water standards for inorganic and organic chemicals, and the
proposed drinking water standards for pesticides are listed in Table E.
(Note: Interim standards for aldrin, dieldrin, and DDT will be proposed
pending the completion of a survey of selected water supplies. The survey
is intended to estimate the current level of pesticides in U.S. drinking
water supplies.) These standards are only concerned with those chemical
substances regulated for health reasons. Other drinking water standards are
concerned with such aesthetic qualities as odor, foaming and taste.
The rationale used in writing the current drinking water standards was
that substances which may have deleterious physiological effects, or for which
physiological effects were not known, should not be introduced into the water
supply system in a manner which would permit them to reach the consumer. The
total lifetime environmental exposure of man to a specific toxicant was
considered when arriving at specific limits for the proposed interim primary
drinking water standards. Choice of the concentration of a given substance
permitted in drinking water was made after allowance for the amount of
toxicant contributed by food (FDA guidelines for maximum allowable concentra-
27
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TABLE E
DRINKING WATER STANDARDS
Current (mg/1) Proposed Interim Primary (mg/1)
Arsenic 0.05 0.05
Barium 1.0 1.0
Cadmium 0.01 0.01
Chromium (Cr+6) 0.05 0.05
Cyanide 0.2 0.2
Fluoride
Daily air temperatures (°F)
50.0 - 53.7 1.7 2.4
53.8 - 58.3 1.5 2.2
58.4 - 63.8 1.3 2.0
63.9 - 70.6 1.2 1.8
70.7 - 79.2 1.0 1.6
79.3 - 90.5 0.8 1.4
Lead 0.05 0.05
Mercury none 0.002
Nitrate 45. (undesirable) 10.
Organics - Carbon 0.2 0.7
Absorbable
Selenium 0.01 0.01
Silver 0.05 0.05
28
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TABLE E (continued)
DRINKIN3 WATER STANDARDS
Pesticides
(i) Chlorinated Hydrocarbons
Chlordane
Endrin
Heptachlor
Heptachlor Epoxide
Lindane
Methoxychlor
Ibxaphene
(ii) Chlorophenoxys
2.4-D
2,4,5-TP Silvex
Proposed Interim Primary (mg/1)
0.003
0.0002
0.0001
0.0001
0.004
0.1
0.005
0.1
0.01
29
-------
tions), or other environmental factors (such as the amount of lead asbestos
through inhalation by people living in urban areas).
In formulating the proposed interim primary drinking water standards,
consideration was given to the toxicities of a given substance and the like-
lihood of bioaccumulation, carcinogenicity, mutagenicity, or teratogenicity
of that substance. Studies investigating the characteristics of a substance
offered evidence that was often unclear, and sometimes conflicting, thus
making the choice of a "safe no-effect" level in drinking water quite diffi-
cult. A safety factor, varying with the reliability of the evidence, was
therefore used in derivation of the interim primary drinking water standards.
The level of control chosen minimized the amount of a toxicant contributed
by water, and this level was generally attainable by good quality control.
Federal Water Pollution Control Act, as Amended (FWPCA)
Sec. 304 (a) (1) — Water Quality Criteria. The Administrator is obligated
by this section to publish criteria for water quality taking into account
identifiable effects on the propagation of fish and wildlife, recreational
activities, public water supplies, and agricultural, industrial and other
activities. Inorganic and organic chemicals for which water quality
criteria have been written for health reasons appear in Table F.
Considerations similar to those mentioned for formulation of the pro-
posed interim primary drinking water standards were used in derivation of
30
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TftBLE F - WMER QUALITy CRITERIA
Substance
Arsenic
Barium
Beryllium *
Cadmium
Chlorine
Chromium
Copper
J3vanj.de
Iron
Lead
Manganese
Dcnestic water
Supplies (mj/l)
0.05
1.0
none1
0.01
none
0.05
(aesthetic)
0.2
(aesthetic)
0.05
(aesthetic)
Freshwater
Aquatic T.ife (mg/1)
none
none
0.011 - soft freshwater
1.1 - hard freshwater
soft water hard water
0.0004 0.003 - for cladocerans
0.004 0.012 - for other, less
0.003 - salmonid fish
0.01 - other freshwater organisms
0.3
+
0.005
1.0
**
none
Marine Aquatic
Life (mg/1)
none
none
none
0.005
and salmonid fishes
sensitive, aquatic life
0.01
none
+
0.005
none
none
0.1 - for protection of
OHwr Imj /I )
• - irrigation of crops
none
0.1 - continuous use on all soils'
0.5 - short-term irrigation on
neutral to fine-textured soils
none
none
none
none
0.005 - wildlife
none
none
none
consumers of marine mollusks
Msrcury
Nitrate
Pthalafce ester
Polychlorinated
Selenium
Silver
Zinc
0.002
10.0
none
biphenyls ' none
0.01
0.05
(aesthetic)
0.00005
none
0.003
0.000001
***
***
***
0.0001
none
none
0.000001
***
***
none
0.00005 - wildlife
none
none
none
none
none
none
* Soft water is defined as having less than 100 mg/1 hardness as CaC03. Hard water has 100 mg/1 or more of CaC03.
** The reccnmended limit is 0.01 of a 96-hour LC value, using the receiving or comparable water as the diluent and soluble lead measurements
(non-filtrable lead using a 0.45 micron filter) for sensitive freshwater fish species.
The recommended limit is 0.01 of the 96-hour !£5Q, as determined by a bioassay of a sensitive resident fish species.
+ The recommended limit is O.I of the 96-hour
as determined by t. nonaerntor'. bioassay of- a sensitive aquatic resident species.
-------
T3U3LE P - WKTER QUALITST CRITERIA (continued)
Pesticides
Domestic Water SuppHes
(Micrograms/Liter)
Freshwater Aquatic Life
(Micrograms/Liter)
Marine Aquatic Life
(Micrograms/Liter)
Chlorinated Hydrocarbon
Insecticides
U)
tO
Aldrin - dieldrin*
Chlordane
none
0.01
0.004
DDT*
Endrin
Endosulfan
Heptachlor
Lindane
Methcxychlor
Otaxaphene
Qrganophosphate Insecticides
Daneton
Guthion
Malathion
Parathion
Chlorophenoxy Herbicides
2. 4 - D
2, 4, 5 - TP
Oraanochloro Insecticide
Mirex
0.2
0.003
0.01
4.0
100.0
5.0
none
none
none
none
100.0
10.0
none
0.01
0.01
0.01
0.01
0.02
0.01
0.1
0.01
0.1
0.1
none
none
0.001
0.01
none
0.1
0.05
0.03
0.01
0.1
0.01
0.1
0.1
none
none
0.001
* The persistence, bioaccumlation potential and carcinogenicity of these substances make avoidable human explosure or release into
waterways unreasonably hazardous.
-------
the water quality criteria. Also, allowance for the amount of toxicant
contributed by other environmental factors (e.g., food, lead inhalation)
was made when determining recommended concentrations of a given substance
for each of the purposes mentioned above.
Sec. 307 (a) - Toxic Pollutant List. This section of the FWPCA mandates the
Administrator to publish a list of toxic pollutants for which effluent
standards will be promulgated. The criteria used for selection of the toxic
pollutants were published in the Federal ppgi.QtWj. vol. 38., No. 173, Sept. 7,
1973. The proposed toxic pollutant effluent standards, F»tera1 Rpgi.citP»rr Vol.
38, No. 247, Dec. 27, 1973, were recently invalidated in court. Consequently,
the criteria used for selection of these pollutants are currently under
revision.
The criteria published in the Federal Register are briefly discussed as
an indication of what the revised criteria might be. One criterion was con-
cerned with a pollutant's toxicological properties. Evidence that a pollutant
could be "highly toxic" to aquatic or non-aquatic life was reviewed. The term
"highly toxic to aquatic life" was defined as a substance having a 96-hour
of 10 mg/1 or less; this classification was taken from the National Academy
of Sciences water pollution ranking system . The term "LCso" means that
concentration of a substance in water which is lethal to one-half of the test
population in the specified time period. The term "highly toxic to non-
aquatic life" was defined as in Title 15, U.S. Code, Sec. 1261. Less
standardized data, including data from sub-acute and chronic testing, were
reviewed as well.
33
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Toxicological data were reviewed for evidence of bioaccurnulation through
aquatic mechanisms to the extent of reproductive impairment or contamination
of foods. Also, evidence of a substance having carcinogenic, mutagenic, or
teratogenic properties and being stable in the aquatic environment was reviewed.
Another criterion was concerned with the seriousness of discharges or
potential discharges from point sources. The production, distribution, and
use pattern of the pollutant were determined. Identification of toxic pollutant
discharges should demonstrate that substantial quantities of the pollutant, both
in absolute terms and relative to non-point sources, have been deposited in the
aquatic environment. Also, these discharges must have caused substantial
environmental harm, as supported by documented damage to important organisms.
Sec. 311 (b) (2) (A) - Hazardous Substance Spills. This section of the IWCA
authorizes the Administrator to promulgate regulations designating as hazardous
substances those elements and compounds which, when discharged in any quantity
into or upon the navigable waters, adjoining shorelines or the waters of the
contiguous zone, present an imminent and substantial danger to the public
health or welfare. The constraint in designation of hazardous substances of
an "imminent danger" precludes use of criteria characterized by long-term
effects, i.e., bioaccumulation, carcinogenesis, mutagenesis, or teratogenesis.
Consequently, hazardous substance designation is based on acute effects only.
34
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Criteria to be used for hazardous substance designation under this
section were proposed in the Federal Register, Vol, 39, No. 164, August 22, 1974,
("Designation and Removability of Hazardous Substances from Water"). The oral,
dermal, and inhalation toxicity criteria are identical to the "highly toxic"
criteria found in Title 15, U.S. Code, Sec. 1261. Also, substances having
a median inhibitory limit (Hm) of 100 ppm or less are considered as having the
potential for presenting an imminent and substantial danger to the environment
when spilled. This criterion measures the decrease in aquatic flora, as
indicated by a 50 percent decrease in cell count, biomass, or photosynthetic
ability over a 14-day period. This criterion, while not specifically
mentioned in Sec. 311, is included because aquatic plant life is of critical
importance to aquatic fauna.
The last toxicological criterion used in designation of hazardous substances
is a 96-hour aquatic I£50 of 500 ppm. The basis for the chosen limit is a calcu-
lation determining the achievable pollutant concentration in the average spill
situation. Assumptions are made concerning the volume of water flowing in a
stream, the size of a water body, uniform mixing within a given discharge
time, and concentration of hazardous substances likely to result from typical
capacity sizes of various transportation modes. The calculation then predicts
that the concentration of a hazardous substance would rarely exceed 500 ppm.
Another criterion mandates that a reasonable potential for spillage of
the material be established. Factors considered in making this evaluation
35
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include the production quantities, modes of transportation, handling and storing
practices, past spill experience, and physical-chemical properties of each
substance.
Additionally, EPA is soliciting comments on the economic impact of the
proposed regulation. The cost of spill prevention or the impact of penalties
borne by affected parties will be considered.
Air Arrh - fieri . 112
This section of the Clean Air Act authorizes the Administrator to publish
a list of hazardous air pollutants for which emission standards will sub-
sequently be promulgated. "Hazardous air pollutants" are those which may
cause, or contribute to, an increase in mortality or an increase in serious
irreversible or incapacitating reversible illness. This definition is
concerned only with the safeguarding of human health.
A preferred standards path analysis is performed for a pollutant being
considered for hazardous designation. Ambient air data, health effects
information, the technical feasibility of controlling emissions, and the
economic implications of regulating the substance are assembled in an
analytic document. Considering all this information and anticipating the
practicality of emission standards implementation, decision-makers subjectively
pass judgment as to whether or not a substance should be designated as
hazardous. Asbestos, beryllium, and mercury, having been designated as
hazardous, are currently regulated by emission standards.
36
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EPA Sewage Sludge Working Group
Tliis Working Group is presently formulating guidelines for the heavy metal
content of sewage sludge applied to cropland or land used for cattle grazing.
Recommended levels have yet to be determined.
TRW Systems Group
Recommended Methods, of Reduction, Neutralization,
Recovery, or Disposal of Hazardous Waste
The TRW report initially classifies waste stream constituents into three
categories: Category 1, candidates for National Disposal Sites; Category 2,
candidates for Industrial Disposal; and Category 3, candidates for Municipal
Disposal. Classification of waste stream constituents requires consideration
of both the hazards associated with the constituents and the evaluation of
the adequacy of the currently practiced treatment and disposal practices.
The criteria used in classifying waste stream constituents are as follows:
Category 1: Materials are very difficult to handle,
have Threshold Limit Values less than or equal to
1 ppm, and/or are very highly flammable, and/or are
currently regulated or considered for regulation by
the Environmental Protection Agency.
Category 2: Material can be handled by normal
industrial procedures, can be incinerated with proper
scrubbing equipment, buried without treatment in a
Class 1 landfill, or broken down by biological processes
as utilized by industry.
Category 3: Materials are relatively easy to handle,
can be incinerated without scrubbing, buried in a
Class 2 landfill, or treated by municipal sewage
treatment processes.
37
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The landfill classifications are taken from, the California State
Department of Public Health, the Department of Water Resources. Class 1
landfills are those sites located over non-^water bearing sediments or with
only unusable ground water underlying them. The site location must
provide complete protection from flooding, surface runoff or drainage,
and waste materials and all internal drainage must be restricted to the
site. Class 2 landfills are sites underlain by usable ground water, and
they may be located adjacent to streams. A distance of separation must
be maintained between the bottom of the fill and the water table. Surface
water must be restricted from the site, to preclude water contact with
the wastes.
A Profile Report is prepared for each of the waste stream constituents
studied. The first three sections of the report present information charac-
terizing the waste stream constituent. An introductory section contains such
information as manufacturing techniques, production rates, use patterns, and
types, quantities, sources, and distribution of wastes containing the
constituent. Pertinent physical/chemical properties of the material are also
summarized here. A toxicology section generally documents recommended Thres-
hold Limit Values (TLV) for man, the Tim for fish, acute oral and dermal LDso
values for various forms of animal life, plant reactions following exposure,
and exposure symptoms in man. (The TLV is that concentration of an airborne
constituent to which workers may be exposed repeatedly, day after day, with-
out adverse effect.) A section describing other than toxicological (or radia-
tion) hazards completed the characterization of the constituent. The types of
38
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hazards included in this section are flammability, explosiveness, corrosiveness,
and detectability.
The next section of the Profile Report discusses the overall hazard
associated with the waste management sequence between waste constituent
generation and waste disposal. Adequate waste management is defined in
terms of maximum acceptable levels of occurrence in air, water, and soil,
based mainly but not solely on the toxicological effects of the waste
constituent. Maximum acceptable levels of occurrence are designated as
Recommended Provisional Limits.
Tlie Recommended Provisional Limits in air are equal in value to one-
hundredth of the established TLV. For constituents without an established
TLV, that of a structurally related compound is used. The Recommended
Provisional Limits in water and soil are equal in value, based on the
worst case assumption that contaminated soil is completely non-retentive,
and that the contaminant eventually percolates to the ground water table,
and eventually becomes potable water. These concentration limits are equal
in value to current drinking water standards, or one-hundredth of the lowest
reported drinking water study level in cases where no drinking water standard
exists.
In the absence of drinking water standards or study limit values,
provisional limits are calculated on the basis of the Stokinger and Woodward
method. By this method, limiting concentrations for water are based on the
39
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TLV's of hazardous itaterials. The assumption underlying this method is
that the noninjurious amount taken into the blood stream by inhalation is
equal to that which can be taken orally in water. When this calculation is
applied and no established TLV exists, then the TLV of a structurally related
compound is used.
TEW reports that in a reasonable number of instances drinking water
standards are roughly approximated by using a 100-fold safety factor to the
lowest drinking water study levels or to the limits obtained by the Stokinger
and Woodward method. limiting concentrations for organic compounds present
the greatest difficulty, however. The Stokinger and Woodward limits often
exceed the rninimum concentration producing detrimental effects in fish. Also,
the calculated value may greatly exceed known odor and taste thresholds for
man. In the absence of additional toxicity or annoyance data, a 100-fold safely
factor ia applied to the calculated values to give the provisional limiting
concentrations.
As an additional safety feature, these limiting concentrations are
compared with "safe" concentrations for fish. The rule-of-thumb method for
determining the "safe" concentration, as reported by Sprague, is to multiply
the 48-hour "Urn by one-tenth. Generally, reconmendations for maximum levels
are 0.1 to 0.05 toxic units for non-persistent pollutants, and 0.1 to 0.01
toxic units for persistent chemicals and pesticides, mostly of the lower
figure. In the absence of TLV's for man, fish limits serve as tentative
limiting concentrations for man.
40
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TABLE G
CRITERIA FOR THE IDENTIFICATION OF CANDIDATES FOR
NATIONAL DISPOSAL SITES
QUANTITY CRITERION
(1) Material is present in sizable quantities as a waste.
HAZARD CRITERIA
(1) Waste material is highly toxic.
(2) Waste material is toxic and not degraded, oxidized, reduced or combined to a nontoxic form
by air, water, or soil organisms.
(3) Waste material is radioactive with long half-life and/or high level radiation.
(4) Waste material is spontaneously combustible or is an explosive sensitive to heat or mild shock.
TREATMENT CRITERIA
(1) No disposal method other than long term or permanent storage 1s considered adequate for the
material.
(2) Adequate disposal techniques for the material are too specialized or complex for general
application.
(3) Adequate disposal methods for the material are under development but not yet available,
requiring short term storage.
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The ratio of the five-day biological oxygen demand to the ultimate
oxygen demand is used as a measure of persistence of a substance in the
environment. Any substance with a value less than 20 percent is considered
to be persistent. Available data on the accumulation of toxic substances in the
ecologic cycle is also used in evaluating the persistence of a substance.
The last two sections of the Profile Report are concerned with evaluation
of current waste management practices and applicability to the concept of National
Disposal Sites. Current waste management practices are evaluated in regards to
disposal efficiency, operational safety, and environmental impact. The final
section recormends the general class of waste treatment required by the subject
waste stream constituents. The criteria used for the identification of candidates
for National Disposal Sites are listed in Table G . This set of criteria reflects:
(1) the abundance of the material present as wastes; (2) the degree of hazard
associated with the waste material, and (3) the complexity of treatment that is
required in the disposal/recovery of the waste material. Unfortunately, the
criteria do not define "sizable quantities," "highly toxic," or "toxic."
6
Battelle Memorial Institute
Program for the Management of Hazardous Wastes
Battelle utilized a decision model (Figure 1) in determining which waste
6
streams should be designated as hazardous . All waste streams were candidates
for hazardous waste designation, regardless of production quantities.
42
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FIGURE 1
GRAPHIC REPRESENTATION OF THE
HAZARDOUS WASTE DECISION MODEL
WASTE STREAMS
DOES WASTE CONTAIN
RADIOACTIVE CONSTITUTES
>MPC LEVELS?
NO
IS WASTE SUBJECT TO
BIOCONCENTRATION?
NO
IS WASTE FLAMMABILITY
IN NFPA CATEGORY 4?
NO
IS WASTE REACTIVITY
IN NFPA CATEGORY 4?
NO
DOES WASTE HAVE AN ORAL LD
< 50 mg/Z?
50
NO
IS WASTE INHALATION TOXICITY
<200 PPM® GAS OR MIST?
LC50<2mg/LAS DUST?
NO
IS WASTE DERMAL PENETRATION
TOXICITYLD50<200mg/kg?
NO
IS WASTE DERMAL IRRITATION
REACTION>GRADE7?
NO
DOES WASTE HAVE AQUATIC
96 HR TLM < 1000 mg/f ?
NO
IS WASTE PHYTOTOXICITY
50<
IL5Q<1000MG/L?
NO
DOES WASTE CAUSE GENETIC
CHANGES?
NO
NONHAZARDOUS WASTES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YtS
HAZARDOUS WASTES
43
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A waste stream meeting any of the following criteria was designated as
hazardous:
1. Radioactivity: waste streams containing radioisotppes
above the accepted maximum permissible concentration
(MFC) levels set by the Atomic Energy Commission (now
the Nuclear Regulatory Commission).
2. Bioconcentration: materials for which the detoxifica-
tion-excretion mechanism is either non-existent or
extremely slow, (these materials can be categorized
as either heavy metals or persistent organic materials).
3. Flaitmability: waste streams qualifying as Category 4
flammable materials by the National Fire Protection
Association (NFPA No. 704M). The classification is
roughly equivalent to Grade 4 of the National Academy
of Sciences (MAS) fire hazard scale mentioned earlier.
Generally, materials qualify as Category 4 flammable
if they are:
(a) flammable gases;
(b) flammable liquids with boiling points
or flash points below 100 F and vapor
densities greater than or equal to
1.1, or
(c) spontaneously combustible in air.
4. Reactivity: materials which in themselves are capable
y of detonation or of explosive decomposition or explosive
reaction at normal temperatures and pressures, Category
4 of NFPA, (No. 704M). The major areas of concern include:
(a) Detonation by electrical shock;
pertinent data can be found in the
National Electric Code, (NFPA No. 70);
(b) Oxidizing materials, includes Grade 4
self-reactive materials in the NAS
rating system;
(c) Polymerization; hazardous wastes
capable of auto-polymerization, includes
Grade 3, self-reactive agents in NAS
ratings;
(d) Explosiveness; primary high explosives-
rated at five inches or less on the
44
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Picatinny Arsenal scale, and
(e) Water or air reactive wastes;
includes material rated as Grade 4
water reactive in the NAS rating system.
5. Oral Taxicity: waste streams having an oral U>50 to man or rats
less than or equal to 50 mgAg- Test data for species other than
humans or rats, or by routes of administration other than oral
are used to estimate an oral value for man or rats in the absence
of such data.
6. Inhalation toxicity: waste having an inhalation LC«>o °f 200 ppm
or less as a vapor or 2 mg/1 or less as a dust or mist.
7. Dermal penetration: wastes having a dermal IDso of 50 rogAg or
less.
8. Dermal irritation: wastes scoring eight or better on the PDA
skin irriation scale (Title 21, CFR, Sec. 191.11) , or a rating
of eight or better on the 10-grade scale devised by Smyth,
et al. A grade eight rating on the latter scale represents
severe irritant effects after a dilution of 100 to 1.
9. Aquatic toxicity: wastes displaying a 96-hour TUn of 1,000 ppm
or less. This level was based on thresholds then being proposed
by EPA pursuant to Sec. 311 of the FWPCA. The proposed threshold
for aquatic life was subsequently revised to a 96-hour TLm of 500
ppro/ (Federal Register. Vol. 39, No. 164, August 22, 1974) .
10. Phytotoxicity: wastes having a mean inhibitory limit, (ILm) of
1,000 ppm or less. This level was chosen for reasons similar to
those for selection of the aquatic toxicity threshold. Also, the
proposed threshold for aquatic flora was subsequently revised to
an Ilm of 100 ppm, (see previous reference) .
11. Genetic effects: wastes found to give positive results to
standard genetic tests. Standard tests for determining carcin-
ogenic, mutagenic, or teratogenic potential have been developed
by the National Cancer Institute.
The decision model just outlined is designed to evaluate entire waste streams.
Unfortunately, a paucity of waste stream data has been collected to date. Lacking
such data, many classification systems rely on the pure compound approach,
successive testing of each waste stream constituent, for determining whether or not
a waste stream should be designated as hazardous. Battelle employs a variant of
this approach for classifying waste streams. An assumption is made that all
45
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constituents are additive in their effects. The additive estimation of toxicity
levels for waste streams is calculated by use of the following model:
•2
1A waste
x=l
where "Y" is the toxicity measurement, i.e., Tim, Ilm, oral or dermal ID or
inhalation LC , and "Px" is the fraction of constituent "x" in the waste stream.
Clearly, toxicological data are not always additive. Smyth, et al., found
that oral ID values for combined organic solvents were quite close to predicted
values. For materials with distinctly different toxic effects, the estimated
limit serves as a maximum unless synergism comes into play.
For other than toxicological measurments, the additive estimate is not as
neatly calculated for the waste stream. Greater subjective judgment for estimating
an entire waste stream's flairmability, reactivity, or dental irritation ratings
is required. Evaluation of a waste stream's potential for bioconcentration and
i
genetic activity is quite difficult, making the additive estimations techniques
highly judgmental.
•7
Booz-Allen Applied Research, Incl
A Study of Hazardous Waste Materials,
Hazardous Effects and Disposal Methods
This report evaluated the degree of hazard associated with a substance in
M
terms of its potential effect on human health and welfare and on other ecological
populations. The human health and welfare category includes effects from flame,
46
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explosion, or reaction, as well as toxic effects resulting from exposure to a given
substance. The category involving other ecological populations documents the toxic
effects resulting from plant or animal exposure to a given substance. The degree of
hazard for each disposal or release medium (air, water, and soil) is evaluated in
terms of the potential effects just described. The matrix of factors used for rating
the level of effects for potentially hazardous substances is depicted in the following
table:
Medium
for
Disposal
Air (A)
Water (W)
Soil (s)
Hazard in Terms of Potential Effects
Human Populations
Toxic Effects Flame/Explosion/
(Th) Reaction (Fh)
ATh
WTh
STh
AFh
WFh
SFh
Eco Populations
Toxic Effects
Cte)
ATe
WTe
STe
Each element of the above matrix is rated using the following scale:
3-Severely hazardous
2-Slight to moderate hazard
1-Minimal hazard
U-Effects unknown
The acute exposure criteria used in designating a substance as severely
hazardous for each of the nine elements depicted in the previous table were as
follows: (Chronic exposure criteria, arbitrarily assumed to be 1/20 to 1/100 of
acute exposures, were also used in designating a substance as severely hazardous.)
ATh: inhalation 1^^5,000 mg/m3; or TLV<500
WTh: oral ]X>5Q<50 mg/k
-------
AFh: Fp ^ 100°F and Bp ^ 100°F; spontaneous
combustion and/or explosive reaction
WFh: reacts explosively with water without
requiring heat or confinenent
SFh: readily capable of detonation and explosive
decomposition or reaction at normal ambient
temperatures and pressures
Ale: inhalation LCL. -^. 2000 mg/m3, or TLV^ 200
mg/m3 50
WTe: Tim ^100 mg/1; or TLV^ 10 mg/1
STe: highly lethal on contact to most vegetation
and/or earth organisms.
NOTE: No time limit for any toxicity measurement, LCL-., I£L0or TL ),
was given. Also, the definition of TLV was expanded to include that dose
(mg/kg body weight) to which humans or animals may be exposed repeatedly or
continuously day after day without suffering adverse effects.
Once ratings for a particular susbtance have been developed for each
element in the potential effects matrix, they are summed vertically and
horizontally to give a total effects rating. Production and distribution
rating criteria are then factored into the calculation according to the
following scales:
Production Rating Criteria
8
1.5 - Large production, amounts exceeding 10 pounds (50,000 short tons),
annually
1.25 - Moderate production, amounts at least 10 pounds (5,000 short tons),
but less than 108 pounds annually
1.0 - Low production, amounts less than 10 pounds
U - Unknown
48
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Distribution Rating Criteria
0.5 - Wide distribution, more than 10 major producers, shipments in less
than tank car containers, used as both intermediate industrial and
consumer product.
0.25 - Moderate distribution, 5-10 major producers, large shipments
0.0 - limited distribution, less than 5 major producers.
The final hazard rating is derived by multiplying the sum of the
production and distribution ratings by the total effects rating. Additionally,
a maximum potential hazard rating is calculated by assigning a maximum hazard
value of three for each unknown and incorporating this factor into the total
effects rating.
49
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DEPARTMENT OF DEFENSE
Department of the Amy, Materiel Command, Edgewood Arsenal
A ranked list of industrially supplied chemicals by acute toxicity,
(mammalian oral consumption) , is maintained by the Department of the Army,
Materiel Command, Edgewood Arsenal. The oral LD of each chemical is
classified on a scale ranging from an insignificant toxicity category, to
progressively more toxic categories. The classification used at this
facility is as follows:
Classification Oral LD_
-
0 Insignificant toxicity above 5,000
1 ' 500-5,000
2 ' 50-500
3 ' 5-50
4 Most Toxic 5
g
Department of the Navy
Consolidated Hazardous Item List
The potential danger of supply materials is evaluated in regards to
health hazard, flammability, reactivity, corrosivity, oxidation capacity,
radioactivity, magnetic properties, or fire-fighting hazard. The degree of
hazard classifications relative to health, flammability, and reactivity are
those contained in NFPA Protection Guide No. 704M. This system utilizes
five hazard levels, from four (4), indicating a severe hazard, to zero (0),
indicating no special hazard. The degrees of hazard relative to flammability
50
-------
are outlined in this publication as follows:
Hazard Level Criteria
4 Fp-^.73°F and Bp-^100°F
3 Fp-^73°F and Bp^-100°F, or
200°F
Fp-?»2000F
Material will not burn.
51
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STATE REGULATIONS
California State List
The State of California classifies waste as hazardous if it satisfies
the criteria for any of the following categories: (1) toxic, (2) corrosive
9
and irritant, (3) flammable, (4) explosive, or (5) strong sensitizer.
The toxic, category is subdivided into "highly toxic" and "toxic"
classifications. The "highly toxic" subcategory is identical to that defined
in Title 15, U.S. Code, Sec. 1261. The "toxic" subcategory includes those
substances having (i) an oral LDco greater than 50 mg/kg but not more than
500 mgAg* (ii) an inhalation LC greater than 2 mg/1 but not more than 5
mg/1, or (iii) a dermal ID greater than 200 mg/kg but less than 2,000
mg/kg.
The terms "corrosive," "irritant," "flammable," and "strong sensitizer"
are defined as in Table 15, U.S. Code, Sec. 1261, with the exception that a
"combustible" classification is not included as part of the flammable category.
An explosive is defined as in Title 49 (Transportation), CFR, Sec. 173.50.
52
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REFERENCES
1. System for evaluation of the hazards of bulk water transportation
of industrial chemicals; a report to the Department of Transpor-
tation, United States Coast Guard. Washington, National Academy
of Sciences—National Research Council, Feb. 1974. 42 p.
(Distributed by National Technical Information Service, Springfield,
Va., as AD-782 476.)
2. Christensen, H. E., T. T. Luginbyhl, B. S. Carrol. The toxic
substances list; 1974 edition. HEW Publication No. (NIOSH) 74-134.
Rockville, Md., U.S. Department of Health, Education, and Welfare,
June 1974. 904 p.
3. Personal communication. H. E. Stokinger, National Institute for
Occupational Safety and Health, to A. M. Kohan, Office of Solid
Waste Management Programs, Dec. 1974.
4. Flinn, J. E., T. J. Thomas, and M. D. Bishop. Literature search
and state-of-the-art study of identification systems for selecting
chemicals or chemical classes as candidates for evaluation; final
report. Washington, U.S. Environmental Protection Agency, [1974].
60 p.
5. Ottinger, R. S., et al. [TRW Systems Group.] Recommended methods
of reduction, neutralization, recovery or disposal of hazardous
waste. U.S. Environmental Protection Agency/ Aug. 1973. 16 v.
(Distributed by National Technical Information Service,
Springfield, Va., as PB-224 579.)
6. Program for the management of hazardous wastes for Environmental
Protection Agency, Office of Solid Waste Management Programs;
final report. Richland, Wash., Battelle Memorial Institute,
July 1973. 385 p.
7. Booz Allen Applied Research, Inc. A study of hazardous waste
materials, hazardous effects and disposal methods. U.S.
Environmental Protection Agency, 1973. 3 v. (Distributed by
National Technical Information Service, Springfield, Va., as
PB-221 464.)
8. Consolidated hazardous item list; storage and handling. NAVSUP
Publication 4500. Mechanicsburg, Pa., Department of the Navy,
Navy Fleet Material Support Office, 1 July 1972.
9. Listing of extremely hazardous waste, Sec. 25115, Health and
Safety Code of California. State of California Statues of 1972.
v.l. p. 2387-2393.
53
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APPENDIX
prp
Ui .,»•
NIOSH Recommended Standards Developed Under the
Occupational Safety and Health Act
Ann.or.Ja
Arsprslr
Asbestos
Benzene
Beryllium
Carbon Monoxide
Chloroform
Chromic Acid
Coke Oven Emissions
Cotton Djst
Hot Environments
Inorganic Lead
Inorganic Mercury
Noise
Silica
Sulfuric Acid
Sulfur Dioxide
Toluene
Toluene Diisocyanate
Trichloroethylcne
Ultraviolet Radiation
Vinyl Chloride
July Ji
Janu'ciry
Jf»m:nry
iy?.'i
21.,. K
21 , !'
1974
July 24,
June 30, 197.°.
August 3, 1972
September 11, 1974
July 17, 1973
February 2S, 1973
September 26, 1974
June 30, 1972
January 5, 1973
August 13, 1973
August 10, 1972
Nov emb er 11, 1974
June 6, 1974
February 11, 1974
July 23,
July 13,
July 23,
December
March 11,
1973
1973
1973
20, 1972
1974
54
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FY 75
Aniline
Cadmium
Carbon Tetrachloride
Dioxane
Egress from High Structures
Fluorides
Hexavelent Chromium Compounds
Hydrogen Cyanide
Methylene Chloride
Nitric Acid
Oxides of Nitrogen
Parathion
Sodium Hydroxide
Xylene
Zinc Chloride
Zinc Oxide
Labelling
FY 77
Carbon Dioxide
ya!281
U.S. GOVERNMENT PRINTING OFFICE: 1975—210-810:77
FY 76
Acetylene
Carbaryl
Chlorine
Ethylene Dichloride
Fibrous Glass
Fluorine
Formaldehyde
Hydrogen Fluoride
Isopropyl Alcohol
Malathion
Methyl Alcohol
Methyl Parathion
Phenol
Phosgene
Phosphine
Phosphoric Acid
Phosphorus
Sodium Cyanide
Tetrachloroethylene
1,1,1-Trichloroethane
55
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