INTEGRATED MULTIMEDIA
Control alternatives
DRAFT Phase I Case Study
CHLOROFORM
Contract 68-01-6020
8 June 1981
Abt Associates Inc., Cambridge, Massachusetts
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ABT ASSOCIATES INC
55 WHEELER STREET. CAMBRIDGE, MASSACHUSETTS 021 38
TELEPHONE • AREA <17 492 7100
TELEX 710-320-1382
INTEGRATED MULTIMEDIA
Control alternatives
DRAFT Phase I Case Study
CHLOROFORM
Contract 68-01-6020
8 June 1981
Gene E. Fax, Project Director
Consultants:
Marsha Gorden
Development Sciences Inc.
Francis S. Wright, J.D.
Submitted for review to:
Arnold Edelman
Office of Toxics Integration
U.S. Environmental Protection
Agency
Washington, D. C. 20560
Management Reviewer
Quality Cortfrol Reviewer
.ontract Manager
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Integrated Multimedia Control Alternatives
Draft Phase I Case Study
Chloroform
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TABLE OF CONTENTS
SUMMARY OF FINDINGS
5.0 CHLOROFORM 1
5.1 INTRODUCTION AND FINDINGS 1
5.1.1 Introduction 1
5.1.2 Findings: Multimedia Considerations in Rulemaking 2
5.1.2.1 Consideration in Materials Flows 4
5.1.2.2 Consideration in Human Exposures 5
5.1.2.3 Consideration of Health Effects 6
5.1.3 Findings: Unanticipated Effects of Regulations 6
5.1.4 Findings: Regulatory Gaps 6
5.2 REGULATORY HISTORIES 8
5.2.1 Office of Air Quality Planning and Standards (EPA/OAQPS) 8
5.2.1.1 National Ambient Air Quality Standards 8
5.2.1.2 New Source Performance Standards 8
5.2.2 Office of Water Regulations and Standards (OWRS) 10
5.2.2.1 Toxic Pollutant Effluent Standards 10
5.2.2.2 Water Quality Criteria 14
5.2.2.3 Effluent Limitations, New Source Performance Standards, 21
and Pretreatment Standards for New and Existing Sources
5.2.2.4 Designation of Hazardous Substances and Reportable 26
Quantities
5.2.3 Office of Drinking Water (ODW) 31
5.2.3.1 Maximum Sontaminant Levels of Tribalomethanes 31
5.2.3.2 Underground Injection Control 38
5.2.4 Office of Solid Waste (OSW) 42
5.2.'4.1 Hazardous Waste Management System 42
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Table of
Contents (continued)
5.2.5 Office of Pesticide Programs (EPA/OPP) 47
5.2.5.1 Registration of Pesticides 47
5.2.6. Office of Water Program Operations (EPA/OWPO) 48
5.2.6.1 Ocean Dumping Criteria 48
5.2.7 Occupational Safety and Health Administration (OSHA) 50
5.2.7.1 Occupational Exposure to PCBs 50
5.2.8. Food and Drug Administration 53
5.2.8.1 Adultered and Misbranded Food and Drugs 53
5.2.9 Department of Transportation (DOT) 55
5.2.9.1 Hazardous Materials Regulations 55
APPENDIX
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SUMMARY OF FINDINGS
Chloroform is present in all environmental media, in the workplace,
and in food. Nevertheless, much is unknown concerning the sources of the
chemical, the amounts emitted to the various media, its migration between
media, and its formation and degradation in the environment. A major
unknown is the amount emitted to air; estimates taken from EPA background
documents differ by up to a factor of two, and disagree completely regard-
ing the ma]or sources. Attempts to construct mass balances have been made
only in the last three years, and are based largely on crude estimation
techniques. On the other hand, several EPA actions concerning water have
attempted to account for chloroform intake from air and food when setting
standards and criteria. These attempts have been hindered by lack of
reliable data.
Final rules governing environmental chloroform have been issued for
drinking water, drugs, cosmetics, emissions, from waste transport, storage
and disposal facilities, and spills into navigable waters. Rules have been
proposed for food and wastewater effluents from pulp and paper mills. No
actions have been undertaken to control emissions to ambient air, or to
update obsolete workplace air standards. Most of the rulemaking activities
concerning chloroform that have taken place in the last five years have
been based on a National Cancer Institute bioassay demonstrating the
chemical's carcinogenicity in rats and mice. Apart from this common
origin, there has been only a moderate amount of technical interaction
among the various agencies' regulatory activities. Most has taken place
within EPA's water-related programs, with the exception of proposed
effluent guidelines. Proposed rules on chloroform in pesticides and foods
took no account of intermedia issues.
Some of the existing or proposed rules controlling chloroform could
possibly be the cause of unwanted emissions themselves. Biological treat-
ment for pulp and paper mill wastewater could result in volatilization from
aeration lagoons. The drinking water standard for trihalomethanes could
increase contamination of soil and air, because of the need to regenerate
carbon adsorbers and to dispose of spent carbon. Workers who maintain
pollution equipment could suffer increased exposure. But whether these
potential problems would be serious is difficult to gauge, because of the
lack of information on chloroform's occurrence and fate.
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5.0 CHLOROFORM
5.1 INTRODUCTION AND FINDINGS
5.1.1 Introduction
The subject of this case study is the degree to which Federal
regulatory agencies have taken multimedia effects into account in their
rulemaking procedures to control chloroform in the environment. Three major
issues are the focus of attention:
1. The degree to which each agency, during rulemaking,
considered the presence of chloroform in media other
than the one or ones being regulated at the time.
2. Whether regulatory actions aimed at a particular
medium had unanticipated effects on release of
chloroform into other media.
3. Whether any gaps in regulatory coverage are apparent.
Other issues are also discussed. These include the extent to which particu-
lar regulatory efforts acknowledged similar past or ongoing efforts in other
agencies; the technical basis for the standards; and the degree to which
economic impacts were included in the decision-making. Findings on these
subjects will be incorporated into a cross-substance analysis in a later
phase of the project.
The scope of the analysis and the sources of information have been
described in the introduction to the Lead case study (Section 1.1.1). Also,
the general provisions of applicable toxic substance regulations (such as
those under RCRA) have already been treated there. In this case study, we
examine chiefly with those regulatory provisions which deal specifically with
chloroform. Additional discussion of regulations which dealt with volatile
organic compounds as a class of which chloroform is a member may be found in
the Trichloroethylene case study (Section 2.0).
The main reason chloroform was selected for case study is that
relatively little of the chloroform to which people are exposed occurs as the
result of direct anthropogenic emissions. Much of it is apparently created
in situ as a result of chemical reactions within the various media. The most
1
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familiar instance, and the one which has received the most regulatory atten-
tion, is the creation of chloroform as the reaction product of chlorine with
other organic chemicals present in drinking water. Since the reason for
adding chlorine to the water is to reduce microbial contamination, controlling
the chloroform which results raises the interesting problem of trading one
risk (infection) off against another (possible carcinogenesis).
In other respects, chloroform is similar to trichloroethylene,
which is the subject of another case study (Section 2). It has a low bioaccu-
mulation factor, and its major fate appears to be photo-oxidation in the
troposphere. It is an acute and chronic health hazard at moderate concentra-
tions such as are found in the workplace, but rarely poses these problems in
the ambient environment. On the basis of laboratory evidence, chloroform is
suspected of being carcinogenic; but epidemiological evidence is lacking to
establish it as a causative agent of cancer in humans. As a result, the
various regulatory agencies have differed in their assessment of the risk
chloroform poses to man. For these reasons, chloroform is an interesting
subject for a multimedia case study.
5.1.2 Findings: Multimedia Considerations in Rulemaking
Exhibit 5.1 shows the major regulatory actions regarding chloroform
and the interrelationships among them. Two types of connections are shown:
technical interactions (dotted arrows) and regulatory coordination (dashed
arrows).* It should be emphasized that the technical interactions illustrated
in the exhibit are those which are evident from the agency documentation for
each action: that is, the preambles to the proposed and final rules, and
formal background documents such as Environmental Impact Statements, Criteria
Documents, etc. Other interactions between programs—memoranda, meetings,
etc.—have not been accessed for this analysis. Therefore, it is likely that
more technical interactions took place than are shown. Nevertheless, the
For the purposes of this report, "regulatory coordination" is defined as
occurring when the provision of one rule are specifically designed to
complement, supplement, or otherwise take account of the provisions of
another rule. Liaison among regulatory agencies occurs constantly; this
is not included in the definition of "regulatory coordination" unless
the results are visible in the provisions of the regulations.
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formal documentation constitutes the public record of the technical inter-
change, and this is what the exhibit reflects.
Exhibit 5.1 shows that the major regulatory programs controlling
environmental releases of chloroform are those relating to drinking water,
ambient water, and solid waste disposal. Ambient and workplace air have not
been regulated at all; standards for human food have been proposed, but not
made final. Among the standards which do exist, two sets of regulatory
interactions may be observed:
1. The designation of chloroform as a toxic pollutant
results in the promulgation of a Water Quality Cri-
terion and in its listing as a hazardous waste
constituent under RCRA.
2. The disposal and transportation provisions of RCRA
are coordinated with those of DOT and the Office of
Drinking Water (via the Underground Injection Control
regulations).
The details of these interactions are described in Section 5.2. To the
extent past regulatory coordination has taken place among jurisdictions
concerned with chloroform, it has occurred because of the structures of the
relevant acts themselves, not because of initiatives among the affected
agencies. For example, the water programs are statutorily required to give
priority to toxic pollutants, and the RCRA disposal rules are required to
take account of rules under other EPA acts in any case.
In the case of technical interactions, the exhibit shows few
cases of one program using data or methods from another. The main instances
shown are from the water-related programs; ODW and OWRS discussed each
other's methods of estimating cancer risk in their respective attempts to
derive maximum contaminant levels for drinking water, water quality criteria
for ambient water, and reportable quantities for hazardous spills. In
addition, OSW used data from OSHA and ODW when listing chloroform as a toxic
constituent. But this impression of sparsity is misleading in one sense.
Virtually all regulatory initiatives since 1976 have been heavily influenced
by the National Cancer Institute (NCI) bioassay of chloroform. Also, the two
criteria documents published by the National Institute of Occupational Safety
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and Health (NIOSH) have influenced other actions, such as EPA's Water Quality
Criteria. NCI and NIOSH, however, are not regulatory agencies and thus do
not appear on the chart. Furthermore, four of the IRLG agencies (EPA, OSHA,
FDA, and CPSC) have closely coordinated the development of their cancer
policies, which are not shown on the chart unless they have been specifically
applied to chloroform. With these exceptions, the impression given by the
chart is accurate: there has been little technical fertilization across
jurisdictions and, hence, across media. Section 5.1.2 describes the extent
to which intermedia analysis has been included in past and ongoing regulatory
efforts.
In the subsections below, we summarize and integrate the information
described in detail in Section 5.2 for each regulatory program. The discus-
sion is organized around the following topics:
• Consideration of materials flows in regulatory development;
• Consideration of human exposures; and
• Consideration of health effects.
5.1.2.1 Consideration of Materials Flows
Present knowledge regarding the flows of chloroform into, within
and among the various media must be characterized as sketchy. As a result,
none of the present or proposed actions to control the substance are based on
a materials flow analysis.
The lack of information on flows of chloroform is well illustrated
in the documents reviewed in Section 5.2. The most significant gap in
knowledge regards the amount emitted annually to the air and the sources
doing the emitting. A recent report written for EPA's Office of Water
Regulations and Standards (Reference 2 in Section 5.2.2) estimated that 42.3
million pounds of chloroform was released to ambient air in 1978, of which
63% was from pulp and paper bleaching (Exhibit 5.4). A document released a
few months later by the Office of Air Quality Planning and Standards (Reference
1 in Section 5.2.1.2) showed only 24.4 million pounds emitted to air in 1978;
and of this 96% derived from chloroform's use as "solvent, miscellaneous".
Yet the OWRS report states that "the use of chloroform as an industrial
solvent, and in the textile and dye industries, was investigated...and found
to be insignificant." Similar discrepancies occur with respect to the
relative importance of natural vs. anthropogenic sources. The National
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Academy of Sciences* proposed that a large proportion of airborne chloroform
may result from diffusion of dissolved gases from the ocean, and that secon-
dary formation in the atmosphere from man-made precursors may be significant
as well. In the presence of major disagreements regarding the sources and
amounts of chloroform emissions, any mass balance computations must be
regarded as exploratory only.
5.1.2.2 Consideration of Human Exposures
Another aspect of multimedia analysis is the computation of human
exposure from individual media and from several media at a time. In two of
its major regulatory actions concerning water, EPA attempted to account for
the fact that chloroform exposure may occur from air and food as well. These
actions were ODW's Maximum Contaminant Level for drinking water and OWRS1
Water Quality Criterion for ambient water (see Sections 5.2.3.1 and 5.2.2.2
respectively). The estimates derived in the two cases were similar in that
they showed drinking water to account for about 2/3 of the adult males'
exposure under "mean" conditions. The total uptake derived from all sources,
however, was different in each case, ODW estimated 93 mg/yr and OWRS computed
22 mg/yr. The difference is based largely on different assumptions regarding
what constitute "mean" chloroform concentrations in each medium.
In a third water-related action, however, EPA did not consider
multimedia exposures. In its proposed revision of the quantity of chloroform
reportable as a hazardous spill, OWRS based its computations on the assumption
that all human exposure would occur as a result of such spills (see Section
5.2.2.4). Ambient concentrations were ignored.
The Food and Drug Administration, the only agency besides EPA that
controls chloroform in specific media, took no account of levels of human
exposure in its actions to ban the chemical in drugs and cosmetics. FDA's
proposed ban on chloroform in food, which has not yet been made final, was
unaccompanied by any estimates of human intake (see Section 5.2.8).
~National Academy of Sciences, "Chloroform, Carbon Tetrachloride and Other
Halomethanes: An Environmental Assessment," Washington, D.C., 1978.
This report contains a thorough review of the environmental distribution
and health effects of chloroform as they were understood in 1978. However,
because it was to be used in support of any regulatory action, it falls in
the category of "background research" and is not reviewed in Section 5.2
below.
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5.1.2.3 Consideration of Health Effects
The National Cancer Institute bioassay of 1976 forms the basis for
almost all of the actions taken to control environmental chloroform. Of all
standards currently proposed or in force, only the OSHA Threshold Limit
Value, adopted from a 1968 consensus rule developed by a private standard-
setting organization, is based on chloroform's chronic and acute effects. In
three EPA actions similar methods were used to compute the expected excess
cancer risk from chloroform exposure. These actions were ODW's Minimum
Contaminant Level in drinking water, OWRS' Water Quality Criterion, and OWRS'
Reportable Quantity for hazardous spills (see Sections 5.2.3.1, 5.2.2.2, and
5.2.2.4 respectively). FDA did not perform any risk assessments, nor did the
other offices of EPA.
5.1.3 Findings: Unanticipated Effects of Regulations
The intermedia effects of regulatory control were generally ignored
in the various rulemaking processes. Some of these effects could be negative.
For example, the use of biological treatment to remove chloroform from pulp
mill wastewater could cause large amounts of the chemical to volatilize from
aeration lagoons. Several of the actions—for example, the Maximum Contami-
nant Level for drinking water and the Effluent Limitation Guidelines for the
pulp and paper industry—could result in maintenance workers and operators
being exposed to increased chloroform levels. On the other hand, the general
reduction of chloroform levels in water, in compliance with the Water Quality
Criterion, could reduce volatilization to air as well.
5.1.4 Findings; Regulatory Gaps
Ambient Air
Emissions of chloroform to air are virtually unregulated. Inci-
dental reductions in chloroform emissions rates may be achieved as a result of
the National Ambient Air Quality Standard for hydrocarbons, but the chemical
is not specifically controlled by any air-related standard. This is a
serious gap, in light of the acknowledged cancer risk and the fact that EPA
studies ascribe up to 60% of total chloroform exposure to inhalation (see,
for example, Reference 3 in Section 5.2.2). Additionally, a recent report
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(Reference 2 in Section 5.2.2) estimates that 93% of all chloroform emis-
sions are released to the air, and that 63% of all air emissions, amounting
6
to 12,100 x 10 kg, come from one industry, pulp and paper bleaching. No
rules have been proposed to control airborne chloroform releases from this
industry.
Water
Toxic effluent guidelines under the Clean Water Act (Section 307)
have not been promulgated for chloroform, although it is classified as a
toxic substance. This means that control of chloroform discharged to POTW's
and surface waters is left up to the point-source category effluent guide-
lines and pre-treatment standards.
Spills of hazardous substances from a) industries operating under
NPDES permits or b) publicly owned treatment works (POTW's) are currently
unregulated under the CWA (Section 311). Chloroform is classified as a
hazardous substance.
Soil
POTW's which accept hazardous waste exclusively from small genera-
tors are exempt from disposal regulations under Subtitle C of RCRA. Instead,
they are allowed to send their sludges to municipal landfills which are
approved by states under the provisions of Subtitle D. Approval standards
under Subtitle D have not yet been promulgated.
Workplace Air
The current OSHA standard for chloroform in workplace air, which
was adopted in 1971, took no account of the chemical's possible carcinogeni-
city in humans. NIOSH has recommended that the maximum allowable chloroform
concentration be lowered by a factor of 10 for general workplaces and a
factor of 25 for some medical facilities (References 2 and 4 in Section
5.2.7.1). OSHA has not announced any intention to proceed on these recommen-
dations.
Food
Despite the mandatory ban provisions of the "Delaney clause"
(Section 409(c)(3)(A)) of the Federal Food, Drug and Cosmetic Act, chloroform
in food remains unregulated by FDA. A ban on chloroform as a component of
food-contact articles and as a food additive was proposed in 1976, but has
been delayed pending further risk assessment studies.
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5.2 REGULATORY HISTORIES
5.2.1 Office of Air Quality Planning and Standards (EPA/OAQPS)
5.2.1.1 National Ambient Air Quality Standards
Current Status of Action
There is no National Ambient Air Quality Standard for chloroform
per se; it is indirectly regulated by two NAAQS's, one for ozone and one for
hydrocarbons. The first NAAQS allows ambient air concentrations of ozone to
exceed 0.12 ppm (235 mg/m^) for not more than the equivalent of one day per
year (40 CFR 50.9). One technique for complying with this standard would be
to reduce emissions of volatile organic compounds, of which chloroform is
one. The second NAAQS limits ambient air concentrations of total hydrocarbons
to a maximum of 160 nig/m"* in any 3-hour period, this limit not to be
exceeded more than once per year (40 CFR 50.10). Although these standards
have an indirect effect on levels of chloroform in the air, a review of the
Federal Register and the background documentation, particularly the report
"Air Quality Criteria for Ozone and Other Photochemical Oxidants" (1), makes
it clear that chloroform was not a substance of specific concern at the time.
We shall therefore not review the regulatory histories of these two standards.
5.2.1.2 New Source Performance Standards
Current Status of Action
No existing or proposed New Source Performance Standards address
chloroform explicitly. Proposals exist to regulate several industries for
hydrocarbons (alternately called volatile organic compounds, or VOCs), of
which chloroform is one. These industries include synthetic organic chemical
manufacturing (46 FR 1136), organic solvent cleaning (45 FR 39766), coil
coating (F6 FR 1102), industrial surface coating (45 FR 85085), and metal
furniture coating (45 FR 79390). Final rules limiting VOC emissions currently
exist for the automobile surface coating industry and for petroleum storage
tanks (40 CFR 60 Subparts MM and K respectively). Of all these industries,
however, only synthetic organic chemical manufacturing is likely to have
chloroform as a significant constituent of its VOC emissions.
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Multimedia Considerations in the Regulatory History
The only rulemaking action under NSPS which is likely to have an
effect on airborne chloroform is the proposed rule limiting VOC emissions
from the synthetic organic chemical manufacturing industry (46 FR 1136). The
development of this proposed rule is discussed in the Formaldehyde case study
(Section 6).
A report recently released by OAQPS described the sources of
chloroform air emissions and the resulting human exposure. Entitled "Human
Exposure to Atmospheric Concentrations of Selected Chemicals" (1), the
document estimated that 24 million pounds of chloroform was released to the
air in 1978. This is almost twice the amount estimated for the same year by
the Office of Water Regulations and Standards (see Exhibit 5.5); but as the
details of the estimating procedure are not given, it is not possible to
explain the difference. The report also gave the distribution of people and
dosages by concentration level. These distributions, given in Exhibit
5.2, show that 9.1 million people are exposed to airborne concentrations of
.5 mg/m^-or higher, and that the cumulative "dosage" for these people is
6.9 million (mg/m^) x person. Worker exposures were evidently not included
in these figures. The effects of these exposures on peoples' health were not
discussed.
EPA has announced its intention to regulate airborne carcinogens as
Hazardous Air Pollutants under Section 112 of the Clean Air Act. The agency
has already proposed a regulatory policy for such carcinogens and has issued
an advance notice of proposed rulemaking for generic standards aimed at
curtailing emissions of listed substances (44 FR 58642, 58662). If TCE
should be listed as a hazardous air pollutant by virtue of its presumed or
proven carcinogenicity, then the resulting controls on emissions would be
much stricter than those imposed by the NSPS we have discussed above.
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5.2.2
Office of Water Regulations and Standards (OWRS)
5.2.2.1 Toxic Pollutant Effluent Standards
Current Status of Action
Pursuant to Section 307(a)(1) of the Federal Water Pollution
Control Act, 33 USC 1317(a)(1), chloroform is listed as a toxic pollutant
(40 CFR 401.15). As such, it is subject to effluent limitations reflecting
"the best available technology economically achievable" (BAT), compliance
with which must be attained no later than July 1, 1984 (33 USC s1311(b)(2),
1317(a)(2). Furthermore, modification or waiver of the BAT requirements,
available for conventional pollutants pursuant to 33 USC s1311(c) and 1311(g),
are not allowed for priority pollutants.
EPA policy is to give priority to toxic pollutants in setting
industry-based effluent limitations and pretreatment standards. One set
of proposed industry standards under these programs has included chloroform
specifically as a watewater constituent to be eliminated. This is discussed
in Section 5.2.2.3.
Section 307(a) of the Clean Water Act authorizes EPA to promulgate
effluent standards for toxic pollutants. Section 304(a) authorizes EPA to
prescribe "best management practices" to prevent the release of toxic pollu-
tants from "plant site runoff, spillage or leaks, sludge or waste disposal,
and drainage from raw material storage." Thus far, no regulations have been
promulgated for chloroform under either of these sections.
Multimedia Considerations
Although OWRS has not regulated chloroform under Section 307(a),
two recent studies issued by OWRS indicate ongoing interest in the substance,
and illustrate an increased awareness of the multimedia aspects of chloroform
pollution as well.
The first of these reports, issued in December of 1979, was entitled,
"Water-Related Environmental Fate of 129 Priority Pollutants"(1). Chloroform
was dealt with in nine pages, which summarized current knowledge of the
chemical's persistence and fate as a water pollutant. Seven environmental
processes were examined, six of them representing transfers to or within
media other than water. The processes were:
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Volatilization to air
Photolysis in air
Oxidation in air
Hydrolysis in water
Sorption to sediments
Bioaccumulation in organisms
Biotransformation and biodegradation
by organisms
Process rates and residence times in various media were estimated in the
basis of secondary sources; the results are shown in Exhibit 5.3. As can be
seen, volatilization was deemed to be the primary transport mechanism by
which chloroform leaves water, and oxidation in the troposphere was identified
as the compound's ultimate fate.
The second recent study, issued in November of 1980 by the Monitoring
and Data Support Division, constituted a thorough review of the sources,
environmental distribution, and health and environmental effects of trihalome-
thanes (THM+s), of which chloroform is the most common. Entitled "An
Exposure and Risk Assessment for Trlhalomethanes," (2) the study began by
creating a mass balance for chloroform. Estimates of the amounts of chloroform
produced, used, and released to various media are shown in Exhibit 5.4. Of
the 20,600 kg of chloroform released to the environment each year, about
93% went to the air, 5% to the water, and 2% to land. Sixty percent of total
environmental releases came from the pulp and paper industry, accounting for
two-thirds of the air emissions and 44% of the water emissions. Water
chlorination contributed 17% of atmospheric emissions and 24% of known
aqueous discharges. The study there devoted its attention to the distribu-
tion of chloroform in the various environmental compartments. As in the
earlier study, chloroform's atmospheric fate was deemed to be oxidation to
phosgene and chlorixe oxide, and the major aquatic fate was judged to be
volatilization. Bioaccumulation was not judged to be significant. Using an
EPA partitioning model, the report estimated that, at equilibrium, 99% of
environmental chloroform would reside in the air. With respect to health
effects, the study recounted the results of several laboratory studies
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Exhibit 5.3
Summary of Aquatic Fate of Chloroform
(Source: Reference 1)
mvinoinncntal
Process
Photolysis
Suiiiury
StaLcnv^nL
Probably not significant In
aquatic systems.
ItaLe
Half-Li fe
(tl/2 *
TTi 5 -i IT
lite primary face of this compound 16.8 x 10 _ ^ ^cm y»ec ^ 0.19 years^
Is attack by hydroxyl radicals In 11.9 x 10 cm sec 0.32 years
the troposphere.
Gonf jdeice
of Data
Hud 1um
Oxidation
High
Hydtolyfils
Voltit 11 lzat ion
borptIon
Bloaccumulut Ion
Is probably not u significant
fate process.
The primary transport process
fiom the aquatic environment.
Probubly not significant
Weak to moderate blouccumulatlon;
no evidence of biomagnlflcation of
tlic.liLotumetliune in umrlne food chain.
6.9x10 ^sec |
0.045 months
3,500 years c
15 months d
21+4 minutes'
Medium
Medlun
Medluo
Medlum
H io i rails for ma i lun/
B iodegrada tlon
No specific information, in the sea,
many invertebrates metabolize halogens.
a. ilia pit-dominant environmental process which is thought to determine the fate of this compound
b. Reported as a lifetime (time for reduction to )/e of original concentration) of 0 19 years and
0 32 years, respectively
c. Hydrolysis rate is a minimum tale,
d Hydrolysis rate lb a maximum rate.
e llalf-Mves aie on the order ot several mlmitea to a few hours and depend on the degree of agitation, this
rate Is based on the *_xpei lmeiital results of DlLllug ( 1977) and Hilling e£ aj_ (1975) using a stirred system.
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Exhibit 5.4
Production, Uses and Releases of Chloroform, 1978
(Source: Reference 2)
Production (kkg)
Uses/Releases (kkg)
Commercial Production
Methyl Chloride Process
Methane Process
Loss during Production
Impor ts
Production as Contaminant
Vinyl Chloride Monomer
CH,C1, CH_C1,, and CC1.
3 I 2 4
Chlorination of Mater
Cooling Water
Potable Water
POTW1
Swimming Pools
Bleaching of Paper Pulp
Automobile Exhaust
Phocodecomposition of Trichloroethylene
Marine Algae
TOTAL
122,500
36,000
500
2,679
54
2,460
912
91
159,000
s
7,670
2.733
3.466
12,500
965
450
(unknown)
186,784
Feedstock for F-22 Production
Exports
Incinerated/Retained In Products/Storage
VCM Products
Pharmaceutical Production
F-ll/F-12 Production (and others)
CHCl^ Production
Pesticide Production
Unaccounted for (including laboratory
use and stockpiles)
Released to Environment
CHCI3 Production
Pulp and Paper Bleaching
Chlorination of Uater
Pharmaceutical Extractions
Automobile Exhaust
Trichloroethylene Decomposition
VCM Production
Transportation and Storage Loss
F-22 Production
Pesticides
TOTAL
Ai r
19,207
370<
12.1002
3,2453
1, 525
965
450
187
177
150
38
2,290
1,610
47
17
4
Water
912
14
400
221
275
Land
496
6
290
200
142,700
7.900
3,968
11,600
20,615
186,783
Publicly Owned Treatment Works
2
Arthur D. Little, Inc., estimate
^Arthur D. Little, Inc., after JRB Associates (1980)
4
Average of JRB estimates of controlled (248 kkg) and
uncontrolled (491 kkg) releases.
Source: JRB Associates (1980), except as otherwise noted
-------
(including the National Cancer Institute Bioassay, Reference 3 in Section
5.2.7) to show that chloroform had been shown to be a mammaliar carcinazen
and teratozen. The epidemiological evidence, however, was judged to be
inadequate to reveal a causal relationship between water chlorination and
cancer in humans. Finally, the report estimated human exposures from various
sources including drinking water, air, and food. Intake from drinking water
is shown in Exhibit 5.5, and from air in Exhibit 5.6; the derived values are
consistent with the ranges obtained by the Office of Drinking Water in its
calculations in support of a Minimum Contaminant Level (MCL) for THM's (see
Exhibit 5.13). The average intake from food was computed to be about .006
mg/day, somewhat low compared to the ODW estimate. The study concluded that
inhalation is probably the dominant source of exposure in industrialized
areas, whereas drinking water is probably more important where water is
chlorinated and air levels are low.
While these two OWRS-sponsored reports represent the state of the
art in multimedia analysis, they are difficult to interpret for purposes of
regulatory strategy. This is because the estimates of environmental flows
and human exposures are based on monitoring data taken over a period of at
least seven years. But within that time period numerous regulatory constraints
have been imposed on emissions of chloroform to various media. The extent to
which these constraints have had any effect on chloroform's environmental
distribution has not been considered in deriving the mass balances and
exposure estimates in these reports. Therefore, it is impossible to use
their results to determine which medium or industry should be regulated
next.
5.2.2.2 Water Quality Criteria
Current Status of Action
While water quality criteria published by EPA pursuant to Section
304(a) (1) of the Clean Water Act do not have regulatory force, they may be
used in setting water-quality-based effluent limitations under Section 302,
toxic pollutant effluent standards under Section 303. These latter standards,
in turn, are to be used in establishing individualized effluent limitations
14
-------
Exhibit 5.5
Estimated Chloroform Exposure Via Drinking Water
(Source: Reference 3)
Es11mated Exposure to Chloroform (mg/day)
1,2
Exposure Category
Minimum Intake Maximum Intake Reference Male Reference Female
Adult
median concentration
(0.059 mg/1)
0.02
0. ]3
0.10
0.07
maximum concentration
(0.540 mg/1)
0. 20
1.18
0.90
0. 65
Child
median concentration
(0.059 mg/1)
0.03
0.05
0.06
maximum concentration
(0.540 mg/1)
0.29
0.43
0.51
Includes tap water and water-based beverages.
2
Intakes - Adult - 365-2180 ml/day. Taken from ICRP (1975)
Children - 540-790 ml/day
reference male - 1650 ml/day
reference female - 1200 ml/day
reference child - 950 nl/day (It is unclear why this is not within the range shown above.)
Source: Arthur D. Little, Inc.
-------
Exhibit 5.6
Estimated Chloroform Exposure Via Inhalation
(Source: Reference 3)
Chloroform
Exposure Situation Concentration (ug/m-Q Exposure (mg/day)
Rural 0.07 0.002
Urban (24 hours) 1 0.02
Urban (8 hours) indoor (16 hours) 1, 0.5 0.02
Industrial (8 hours) indoor (16 hours) 50,0.5 0.5
Source: Arthur D. Little, Inc.
16
-------
for NPDES point source discharge permits under Section 402, as well as best
management practices for nonpoint sources under Section 208.
Water quality criteria for chloroform are based on protection of
human health are calculated parametrlcally on the basis of various expected
levels of incremental cancer risk resulting from ingestion of a) aquatic
organisms only and b) aquatic organisms plus water. The derived allowable
concentrations are:
Exposure Assumption Incremental Cancer Risk Criterion (mg/1)
Water and aquatic
organisms
Aquatic organisms only
1°~g 1.90
10" 0.19
10 0.019
10~g 157.0
10"! 15.7
10" 1.57
The criteria for acute and chronic toxicity to freshwater aquatic species are
28,900 mg/1 and 1,240 mg/1, respectively. No criteria were set for protection
of saltwater species.
Multimedia Considerations in the Regulatory History
Section 304(a) of the Clean Water Act requires EPA to "publish and
periodically update national water quality criteria for use by the States in
the development of water quality standards." Under the Act, these criteria
must be protective of public health and welfare, aquatic life, and recreation.
Water Quality Criteria were issued by EPA for various substances in 1968, 1972,
and 1976. In 1976, the settlement agreement in Natural Resources Defence
Council vs. Train (subsequently incorporated into the Clean Water Act Amend-
ments of 1977) required that criteria be issued for a list of 65 specified
toxic pollutants including chloroform; the criteria were to be protective of
aquatic life and human health. These chloroform criteria were published in
1980.
The method by which EPA intended to set criteria for confirmed or
suspected carcinogens was published in the Federal Register on 15 March 1979
(44 FR 15926). EPA would assume that there is no scientific basis for
estimating "safe" levels; instead, the agency would give a range of concentra-
tions estimated to pose alternate degrees of incremental cancer risk ranging
17
-------
from 10 7 to 10 These concentrations were to be presented for informa-
tional purposes, and were not to be interpreted as being "safe", the only
known safe level being zero. The risk estimates were to be extrapolated from
animal experiments to humans using the conservative "one-hit" model endorsed
by the IRLG agencies.
The 15 March notice provided discussions of individual pollutants
which were summaries of the respective Draft Water Quality Criteria Documents.
In the discussion of chloroform, the agency made clear that the basis for
considering the substance as a suspect carcinogen was the 1976 NCI bioessay
which produced cancers in mice and rats (Reference 3 in Section 5.2.7 below).
The epidemiological evidence was judged inadequate to either confirm or
refute a hypothesis of carcinogenicity in man. Human intake of chloroform
from food and air was acknowledged, but the fact that drinking water seemed
to be a more significant route than the others led EPA to ascribe the total
risk of carcinogenic response to ingestion of ambient water and potentially
contaminated fish products. Using the NCI data and the "one-hit" model, the
agency derived the following levels as a function of cancer risk:
Exposure Assumption Incremental Cancer Risk Criterion (mg/1)
2 liters of water
18.7 g of aquatic
organisms per day
Aquatic organisms only
10-6 2-1
10~! 0.21
10 0.021
10_fi 17,5
10~^ 1.75
10 0.175
A summary of the criteria derivation for fresh- and saltwater
species was presented as well. For the former, a maximum concentration was
set at 1,200 mg/1 on the basis of observed acute effects on aquatic inverte-
brates, and a 24-hour average concentration level was set at 500 mg/1 on
the basis of observed chronic effects. The guidelines could not be used
to derive criteria for saltwater species, because no chronic effects levels
were available. Therefore, saltwater criteris were derived by analogy with
bromoform, for which data did exist. The resulting saltwater criteria were
620 mg/1 and 1400 mg/1 for 24-hour average and maximum levels, respectively.
18
-------
The final Water Quality Criteria Document (3) was published in
October of 1980. The discussion of human health effects dealt with routes of
exposure, pharmacokinetics, and toxic effects in mammals and humans. In
examining sources of human intake, the document took extensive account of the
multimedia nature of the exposure problem, and cited studies of chloroform
intake from food (including non-aquatic sources), ambient air, and dermal
contact. Quantitative estimates of human exposure from these sources were
taken from the Statement of Basic and Purpose accompanying EPA's National
Interim Primary Drinking Water Regulations for Trlhalomethames (44 FR 68624;
see Section 5.2.3). In addition, specific instances of drinking water
contamination as a result of industrial wastewater emissions and transpor-
tation accidents were cited. Independent estimates of body burden provided
by the National Academy of Sciences were found to be comparable; see Exhibit
5.7 (and compare with Exhibit 5.13 in Section 5.2.3). The pharmacokinetic
studies, however, showed that chloroform has a brief residence time in
humans, on the scale of hours. The Criteria Document recounted the experi-
mental and clinical history showing chloroform to cause acute and chronic
damage to the liver and kidneys; the development of this topic followed
closely the two NIOSH criteria documents, which were referenced (see Section
5.2.7). The 1976 NCI bioessay (Reference 3 in Section 5.2.7) was cited as
evidence of carcinogenicity; but the epidemiological evidence, all of which
was retrospective, was judged inadequate to establish causality or to be
useful in estimating risk. The document took note of other regulatory
efforts to control chloroform exposure, notably those of NIOSH, FDA, and
EPA's Office of Drinking Water. However, the existence of these actions did
not influence the derivation of the criteria.
The human health criteria promulgated in the Criteria Document are
shown in the "Current Status of Action" portion of this section. The criteria
based on consumption of water and organisms were slightly less stringent;
those based on aquatic organisms alone were more lenient by a factor of nine.
The document did not address the question of why the limits were relaxed.
Comparison of the final document with the proposal, however, reveals three
changes in the assumptions and methods used which could account for the
difference:
19
-------
Exhibit 5.7
Human Uptake of Chloroform and Carbon Tetrachloride from
Environmental Sources, in mg/year
(Source: Reference 3)
At Minimum Exposure Levels8
Adult Man
Adult
Woman
Child
Source
CC14 CHClj
cci4
chci3
cci4
chci3
Fluid Intake
0.73 0.037
0.73
0.037
0.73
0.036
Atmosphere
3.60 0.41
3. 30
0.37
2.40
0.27
Pood Supply
0.21 0.21
0. 21
0.21
0.21
0.21
Total
4.54 0.66
4.24
0.62
3.34
0.52
At Typical
Exposure Levels'*
Adult Man
Adult
Woman
Child
Source
cci4 chci3
cci4
chci3
cci4
chci3
Fluid Intake
1.78 14.90
1.28
10.70
1.28
10.70
Atmosphere
4.80 5.20
4.40
4.70
3.20
3.40
Food Supply
1.12 2.17
1.12
2.17
1.12
2.17
Total
7.70 22.27
6.80
17.57
5.60
16.27
At Maximum
Exposure Levelsc
Adult Man
Adul t
Woman
Child
Source
CC14 CHC13
cci4
chci3
CC1.
4
CHClj
Fluid Intake
4.05 321
4.05
321
1.83
223
Atmosphere
618 474
567
434
405
310
Food Supply
7.33 16.4
7.33
16.4
7.33
16.4
Total
629 811
578
771
414
549
~Source: NAS, 1978a
(a) Minimum conditions of all variables assumed: Minimum exposure-minimum in-
take for fluids; minimum exposure-minimum absorption for atmosphere; and
minimum exposure-minimum intake for food supplies.
(b) Typical conditions of all variables assumed. For CC1.: 0.0025 mg/l-refer-
ence man intake for fluids; average of typical minimim and maximum absorp-
tion for atmosphere; and average exposure and intake for food supplies. For
CHC1,: median exposure-reference man intake for fluids; average of typical
minimum and maximum absorption for atmosphere; and average exposure and in-
take for food supplies.
(c) Maximum conditions of all variables assumed: maximum exposure intake for
fluids; maximum exposure-maximum absorption for atmosphere; and maximum ex-
posure-maximum intake for food supplies.
20
-------
1. A linearized multistage model was used to extrapolate
cancer risks from animal data; the proposal had used
a one-hit model.
2. The earlier assumption that the average daily fish
consumption was 18.7 g was revised downward to 6.5 g.
3. The original bioconcentration factor of 14 was revised
downward to 3.75.
These changes were not specifically discussed as such, so it is difficult
to determine their technical bases.
Finally, the authors of the Criteria Document stated that while
ingestion of chloroform from sources other than water and aquatic organisms
can be estimated, these exposures cannot be taken into account for the
purposes of water criteria formulation until "additional analysis can be
made."
5.2.2.3 Effluent Limitations, New Source Performance Standards, and
Pretreatment Standards for New and Existing Sources
The Clean Water Act Provides four regulatory mechanisms for control-
ling the discharge of toxic pollutants by point sources into surface waters.
These mechanisms are:
Effluent Limitations by application of Best Practicable
Technology (BPT) or Best Available Technology Economically
Achievable (BAT)
New Source Performance Standards (NSPS)
Pretreatment Standards for New Sources (PSNS)
Pretreatment Standards for Existing Soures (PSES)
In practice, these four provisions are administered jointly. Therefore,
we shall discuss them as one program.
Effluent limitations and pretreatment standards are promulgated on
an industry-by-industry basis. No industry is specifically regulated for
chloroform at present, but rules controlling chloroform have been proposed
for the Pulp, Paper and Paperboard and the Builders' Paper and Board Bills
point source categories*. These proposals are discussed below.
~Certain sources in the Steam Electric Generating category are regulated for
emissions of chlorine, a chloroform precursor (40 CFR 423). Chloroform was
detected in wastewater streams of individual plants in the Paint Formulating
category (45 FR 924) and the Iron and Steel manufacturing category (46 FR
1875) but was not selected as a pollutant parameter in either case.
21
-------
Current Status of Action
Guidelines for concentrations of chloroform in wastewater have
been proposed under BAT and NSPS for ten subcategories of the combined Pulp,
Paper and Paperboard and Builders' Paper and Board Mills point source categories*.
The proposed guidelines are shown in Exhibit 5.8.
Multimedia Considerations in the Regulatory History
Various subcategories of the pulp, paper and paperboard industry
were regulated under BPT, BAT, NSPS, and PSNS in May of 1974 (39 FR 16578)
and January of 1977 (42 FR 1398). None of these actions addressed chloroform
as a wastewater constituent. As a result of the Clean Water Act Amendments
of 1977, EPA was instructed to repropose its BAT guidelines, this time
focussing on 65 toxic pollutants of which chloroform was one. Accordingly,
the agency proposed new effluent guidelines for the pulp, paper and paper-
board industries on 6 January 1981 (46 FR 1430). The technical, environmen-
tal and economic justification for the proposal was contained in a preamble
which summarized the contents of an extensive Development Document (4) issued
by the Effluent Guidelines Division of OWRS in November of 1980.
Athough the Development Document was quite long and detailed, its
treatment of chloroform was brief. Chloroform was selected as a pollutant
parameter because it was consistently detected in the raw waste discharge
streams of plants which used chlorine or chlorine-containing chemicals as
bleaching agents. The preferred technique for chloroform control was bio-
logical treatment. As a result of this choice, it was decided not to propose
PSNS or PSES for chloroform, since POTW's (which pretreatment standards are
designed to protect) use biological treatment as their principal technique,
and can thus handle chloroform without pretreatment. In fact, since biological
treatment has already been implemented (or should have been) under existing
BPT guidelines for the control of biological oxygen demand, total suspended
solids, and pH, specifying the same treatment for chloroform control under
BAT would impose no additional cost burden on existing plants. Under NSPS,
some additional costs were expected. These were estimated by assuming that
the contact stabilization activated sludge process would be used in some
subcategories and chemically assisted primary clarification in others.
~Called henceforth the pulp, paper and paperboard industries.
22
-------
Exhibit 5.8
Proposed BAT and NSPS Effluent Limitations for the Pulp, Paper and Paperboard
and Builders' Paper and Board Bills Categories
(All figures in kg/kkg of final product.
Source 46 FR 1430).
Subcategory
BAT
NSPS
Dissolving kraft
0.055
0.051
Market bleached kraft
0.042
0.032
BCT bleached kraft
0.035
0.028
Fine bleached kraft
0.031
0.020
Soda
0.031
0.020
Dissolving Sulfite pulp
0.066
0.059
Papergrade sulfite (function of percent sulfite
pulp in final product)
Deink: fine papers 0.024 0.012
tissue papers 0.024 0.015
newsprint 0.024 0.016
23
-------
In each subcategory, capital costs for model plants were obtained from
various published and supplier sources; allowances for lost production due to
downtime and added power facilities were included. These capital costs were
annualized on a straight-line basis over 16.5 years, but no cost of capital
was included in the calculation. Variable costs included energy, operating
and maintenance labor, and chemicals. No attempt was made in the Development
Document to aggregate the model plant figures into a national total (but see
the Economic Impact Analysis reviewed below). Of course, only a fraction of
the cost of NSPS would be ascribable to chloroform, since other pollutant
parameters were to be controlled as well.
Concerning chloroform as a toxic chemical, the Development Document
gave no information on its health effects or occurrence in the environment.
No mention was made of other attempts to control its release, nor were the
proposed effluent guidelines related to either the proposed Water Quality
Criteria or the Maximum Contaminant Level in drinking water. A brief dis-
cussion of possible impacts of the proposed guidelines on other media contained
no mention of chloroform, although releases of some other pollutants (e.g.,
sulfur dioxide from additional power generating capacity) were mentioned.
Since biological treatment involves aeration lagoons and other free-surface
storage methods, it would seem possible that chloroform could volatilize to
the air in the course of treatment? this possibility was not considered. A
two-page discussion of sludge disposal was provided, but no mention was made
of RCRA, or of the possibility that the sludge could be contaminated with
chloroform (or other pollutants) and thus be classified as a hazardous
waste.
The economic support contained in the preamble to the proposed
guidelines was based on an Economic Impact Analysis (5) released in December
of 1980. Very few of the impacts studied can be ascribed to chloroform
control, since reduction of chloroform is obtained as a "fringe benefit" from
the use of biological treatment for conventional pollutants. Nevertheless,
the method used was very thorough and merits a brief description. A schematic
diagram of the method is shown in Exhibit 5.9. The basis of the approach was
the estimation of both supply and demand curves for each product sector.
These equations were solved first for a baseline (no regulation) case and
24
-------
Exhibit 5.9
Schematic Diagram of Economic Impact Methodology
for Effluent Guidelines
(Source: Reference 5)
DEMAND/SUPPLY
, analysis >
j v
CAPITAL AVAJL ABILITY
ANALYSIS .
mill Shutdown
. ANALYSIS
BALANCE OF
TRADE ANALYSES
COMMUNITY
IMPACT ANALYSIS
SEA MULTIPLIER
OTHER
DRI
DEMAND
MOOEL
CAPACITY
EXPANSION
FORECASTS-
API, OR I
308
SURVEY
INFORMATION
REGIONAL
WAGE
DATA
IOENTIFY
VULNERABLE
SECTORS
PRICE ANO OUTPUT
FORECASTS
CAPACfTY EXPANSION
COSTS
INDIRECT IMPACTS
ON EMPLOYMENT
AND EARNINGS
POLLUTION
COSTS FROM
TECHNICAL
CONTRACTOR
TARIFFS,
FOREIGN POLLU-
TION CONTROL
COSTS AND
SUBSIDIES
PROJECTED MILL CLOSURES,
DIRECT EARNINGS ANO
EMPLOYMENT LOSSES
P V OF NEW CAPACITY,
TOTAL CAPITAL
REQUIREMENTS
NOTE RECTANGULAR BOXES DENOTE INFORMATION FLOWS.
OVAL BOXES DENOTE UNITS OF ANALYSIS
25
-------
then for each of several treatment options, in which the supply curves were
changed to reflect the control costs. The model plant costs provided in the
Development Document were supplemented with survey data collected under
Section 308 of the Clean Water Act, and scaled up for all segments of the
industry. The resulting costs of compliance are shown in Exhibit 5.10, and
the corresponding changes in prices and output are given in Exhibit 5.11. In
both exhibits, the industry subcategories regulated specifically for chloroform
are marked with a (C). Subsidiary analyses were conducted to determine the
availability of capital, the extent of plant closure and consequent losses in
employment, impacts on communities, and implications for the balance of
trade.
5.2.2.4 Designation of Hazardous Substances and Reportable Quantities
Current Status of Action
Chloroform has been designated as a hazardous substance pursuant to
Section 311(b)(2)(A) of the Clean Water Act (40 CFR 116.4, Table 116.4A).
Under 40 CFR part 117, the reportable quantity for spilled chloroform has
been set at 5000 lbs. However, EPA has proposed to lower this amount to 100
lbs. (45 FR 46097). Any discharge of chloroform into navigable waters of the
United States or adjoining shorelines in excess of the reportable quantity
must be immediately brought to the attention of the Coast Guard (40 CFR
117.21), and the discharger is subject to cleanup liability and civil penal-
ties (40 CFR 117.22-23).
Certain types of discharges are excluded from regulation under 40
CFR parts 116 and 117, including those in compliance with permits issued
under the Marine Protection, Research and Sanctuaries Act; the Federal
Insecticide, Fungicide and Rodenticide Act; the Resource Conservation and
Recovery Act; and the dredge and fill provisions and NPDES provisions of the
Clean Water Act. Under certain circumstances, discharges from a point source
in violation of its NPDES permit are also exempted.
Multimedia Considerations in the Regulatory History
Chloroform was designated as a hazardous substance on 13 March
1978 (43 FR 10474), solely on the basis of its aquatic toxicity. On 16
February 1979, EPA announced its intention to expand its selection method to
include other phenomena such as carcinogenicity, mutagenicity, teratogenicity,
26
-------
Exhibit 5.10
Costs of Compliance with Effluent Guidelines and
New Source Performance Standards
(Source: Reference 5; C denotes industry
subcategories controlled for chloroform)
(Millions of 1978 $)
Integrated
(c) Dissolving Kraft
(c) Market Bl. Kraft
(c) bCT Bl. Kraft
(c) Fine Bl. Kraft & Soda
Unbl. Kraft (Linerboard)
Unbl. Kraft (Bag)
Semi-Chemical
Unbl. Kraft and Semi-Chem.
(c) Dissolving Sulfite Pulp
(c) Papergrade Sulfite
Groundwood Thermo-
Mechanical
Groundwood Coarse,
Molded, Newspaper
Groundwood — Fine Papers
Misc. Integrated Mills
Secondary Fiber
Capital Costs
Number
of Mills
Total Annual Costs With Costs
BATEA
67.9
85.7
159.9
67.4
43.7
34.4
73.5
0
92.5
28.2
405.9
NSPS
0
0
4.8
21.1
26.6
5.4
14.7
22.1
0
16.9
11.3
32.6
BATEA
21.6
25.4
49.3
20.5
13.1
11.5
21.5
0
29.1
9.7
124.3
NSPS
0
0
1.6
7.1
8.4
1.8
4.9
7.5
0
5.7
3.8
13.4
2
8
• 8
15
13
10
15
9
0
11
3
5
50
(c) Deink (Fine Papers)
(c) Deink (Newsprint)
(c) Deink (Tissue)
Tissue from Wastepaper
Paperboard from Wastepaper
Wastepaper Molded Products
Builders Paper & Roofing
- Felt
Misc. Secondary Fiber Mills
Nonintegrated
Nonintegrated Fine Papers
Nonintegrated Tissue Papers
Nonintegrated Lightweight
Nonintegrated Filter & Non-
woven
Nonintegrated Lightweight
— Electrical Allowance
Nonintegrated Paperboard
Misc. Nonintegrated Mills
0
21.5
3.6
7.3
*
0
8.0
12.9
1.7
4.7
0
0
10.1
0
4.6
2.5
0
0.5
0
1.5
4.6
0
7.9
1.4
8.3
*
0
2.8
4.0
0.4
1.1
0
0
2.3
0
1.9
1.0
0
0.2
0
0.6
2.8
3
0
7
8
36
3
0
3
14
6
6
0
0
21
Total
1184.3
Source: Meta Systems estimates
~Suppressed due to confidentiality.
174.8
367.7
27
62.5
257
-------
Exhibit 5.11
Effects o£ Effluent Guidelines and New Source
Performance Standards on Prices and Output
(Source: Reference 5; C denotes industry
subcategories regulated for chloroform)
Average Percent Changes
from
Base Case,
1983-85
Contribution
Average Price
Increase, 1983-85
Paoer
Price
Output
to Capital
(1978 $/ton)
Unbleached Kraft
.69
- .75
-1.30
2.00
Bleached Kraft
.83
-2.26
-5.86
2.90
Glassine
1.83
-5.94
7.68
16.00
Spec. Industrial
.61
- .48
.92
5.80
Newsprint
3.20
- .87
3.75
9.60
Coated Printing
.49
- .20
-1.01
2.90
Uncoated Freesheet
.80
- .19
- .51
4.60
Uncoated Groundwood
0
0
-2. 58
0
Thin Papers
.20
- .08
-1.66
1.30
Solid Bl. Bristols
.67
- .24
- .77
3.30
Cotton Fibre
.08
- .15
- .16
1.20
Tissue
.23
- .01
- .31
2.20
Board
Unbl. Kraft Liner. 1.86 - .94 .85 4.30
Bl. Kraft Liner. 2.63 - .99 1.47 7.00
Bl. Kraft Folding 3.57 -2.52 -3.72 15.60
Semi-Chem. Corr. 2.48 -1.76 1.63 5.50
Recycled Liner .18 .01 .57 0.40
Recycled Corr. 1.41 1.90 1.94 3.00
Recycled Folding .07 - .08 - . 51 -30
Constr. Paper £ Bd. 0 0 - .27 0
Molded Pulpt
Solid Bl. Board .72 - .64 - .36 3.30
All Other Board .18 - .11 -1.43 0.50
Pulp
Dissolving 2.85 -2.09 4.04 10.40
Markett
Overall Average 1.02 - .63 - .42 4.10
Source: Meta Systems estimates.
+No demand/supply model.
28
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bioaccummulation, and other long-terra effects (44 FR 10270). However, these
considerations did not figure in the initial selection of chloroform. In the
same issue of the Federal Register, EPA also proposed the institution of
"reportable quantities" representing the amounts of each spilled hazardous
substance above which the discharger was required to notify the Coast Guard
(44 FR 10271). The criteria used for deriving these quantities were entirely
based on considerations of acute aquatic toxicity. One issue having multi-
media implications were raised: the problem of spills into and by POTWs.
Because of the technical problems involved in distinguishing between chronic
discharges and spills, the issue was, for the most part, deferred to later
rulemaking. The part that was not deferred was the case in which the spill
to the POTW was from a mobile source (truck, train, etc.); such spills were
proposed to be included under the reporting requirements of Section 311 of
the Clean Water Act. These provisions, discussed in the proposed Reportable
Quantity Rule of 16 February 1979, were carried through virtually unchanged
to the Final Rule of 29 August 1979 (44 FR 50766), which set the reportable
quantity for chloroform at 5000 lbs.
The first consideration of chloroform's carcinogenicity in connec-
tion with hazardous spills was documented in the Federal Register on July 9,
1980 (45 FR 46097). In that announcement, OWRS proposed to reduce the
existing reportable quantities for six substances, including chloroform,
which had been determined to cause cancer. The method for selecting the new
reportable quantitites was to compute the amount of each pollutant which,
under certain assumptions regarding the mechanism by which individuals become
exposed, would result in a lifetime cancer risk of 10 The method,
including the use of a one-hit model, was adapted from the Water Quality
Criterion computation (see Section 5.2.2.2). Using this technique, a
Reportable Quantity of 100 lbs. from chloroform was derived. No considera-
tion of exposures from sources other than spills was mentioned. This is
surprising in the case of chloroform, since sizeable concentrations of the
chemical are normally present in drinking water even in the absence of
spills.
29
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References for Section 5.2.2
Callahan, M.A. et al., "Water-Related Environmental Fate of 129 Priority
Pollutants," 2 vols., December, 1979, Report EPA-440/4-79-0299a.
USEPA, "An Exposure and Risk Assessment for Trlhalomethanes", Office of
Water Regulations and Standards, Contract 68-01-3857, November,
1980.
USEPA, "Audrient Water Quality Criteria for Chloroform", EPA 440/5-80-033,
October, 1980.
USEPA, "Development Document for Effluent Limitations Guidelines and
Standards for the Pulp, Paper and Paperboard and the Builders'
Paper and Board Mills Point Source Categories", EPA 440/1-80/025-6,
December, 1980.
USEPA, Economic Impact Analysis of Proposed Effluent Limitations Guidelines,
New Source Performance Standards and Pretreatment Standards for the
Pulp, Paper and Paperboard Mills Point Source Category" (2 vols.),
EPA 440/2-80-086, December, 1980.
30
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5.2.3 Office of Drinking Water (ODW)
5.2.3.1 Maximum Contaminant Levels for Tribalomethanes
Current Status of Action
ODW restrictions on total trihalomethanes (TTHMs; a combination of
chloroform and three other trihalogenated methanes) apply to community water
systems which serve 10,000 individuals or more and which add a disinfectant
as part of their treatment process. For such systems, the maximum contaminant
level (MCL) for TTHM's is 0.10 mg/1 (40 CFR 141.12). This restriction takes
effect for large water systems (greater than 75,000 customers) on November
29, 1981 and for all regulated systems by November 29, 1983.
Multimedia Considerations in the Regulatory History
The Office of Drinking Water (ODW) first gave notice of its interest
to regulate organic chemicals in drinking water in July of 1976 (41 FR
28991). In an Advanced Notice of Proposed Rulemaking (ANPRM), the agency
noted the complexity of the problem posed by the possible presence of over
300 organics in drinking water, and discussed chloroform as a specific
example of the issues involved. This discussion, in summary form, proceeded
as follows: Advanced techniques developed in the early 1970s made possible
the detection of minute amounts of chloroform, which was soon found by the
National Organic Reconnaissance Survey to be a widespread contaminant to
drinking water. Its presence was attributed to the practice of chlorination
as a disinfectant procedure. ODW then assigned to its Science Advisory Board
the problem of estimating the resulting health risk, but the Board could only
conclude that, while some risk undoubtedly was present, its magnitude could
not be gauged until further research had been done. Then in 1976, the
National Cancer Institute released a bioassay (1) showing that chloroform
caused cancers in laboratory rats and mice. On the basis of mounting evi-
dence, EPA decided that a) to establish a cooperative program with industry
to reduce chloroform levels without increasing microbiological contamination;
b) to commission the National Academy of Sciences (NAS) to consider chloro-
form's carcinogenicity in its then ongoing research into the health effects
of drinking water contaminants; and c) to collect information which would
allow ODW to evaluate the practicality of alternative regulatory approaches.
Options which ODW said it would consider included:
31
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1. Establishment of MCLs for specific compounds,
either to control worst-case exposures or to
reduce overall exposures to low levels;
2. Establishment of MCLs for general organic
contaminant indicators (but not controlling
specific chemicals);
3. A combination of approaches 1 and 2; and
4. Designation of treatment technologies to control
specific chemicals or total organics.
Although the proposals were meant to apply to organics in general, chloroform
was the most commonly cited example and clearly provided much of the impetus
for the agency's action. The ANPRM did not address the problem of human
exposure to chloroform (or other organics) in other media, restricting
itself to drinking water. Effluents from industrial point and area sources
were cited as originators of many organic pollutants and the ANPRM addressed
briefly the possibility of using the Federal Water Pollution Control Act to
control these. But the discussion made clear that the agency considered
municipal drinking water systems to be the source of chloroform, not indus-
trial effluents, although several industries have since been found to release
the chemical in their wastewater (see Section 5.2.2.3).
In keeping with the agency's policy of pursuing voluntary ways of
reducing chloroform exposures prior to the implementation of mandatory rules,
ODW issued an "Interim Treatment Guide for the Control of Chloroform and
Other Trihalomethanes" (2) concurrently with the publication of the ANPRM.
The following measures were recommended for municipal water systems:
• Adding chlorine at the point in the treatment process
where the water has the lowest organic content, to
reduce chloroform formation;
• Using alternate disinfectants such as ozone, chlorine
dioxide, or chloramine;
• Reduction of water organic content by treatment with
granular activated carbon, prior to chlorination.
Unit costs for each of these treatments were estimated; they are presented in
Exhibit 5.12. Some drawbacks of these techniques were acknowledged, chiefly
tht problem that their residual disinfectant effect was minimal, so some
chlorination would be required anyway. The possibility that chemicals used
32
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Exhibit 5.12
Costs of Trlhalomethane Treatment Processes
(Units: cents per 1000 gal.; Source: Reference 2)
Design Capacity 1 mgd 10 mgd 100 mgd ISO mgd
Average Plant Flow 0.7 mgd 7 mgd 70 mgd 105 mgd
2 mg/I chlorine, 30 rain, contact time 4 1 0.7 0 6
1 mg/Z ozone from air, 20 min. contact time 6 2 0.9 0.8
1 rag/2. ozone from oxygen, 20 min. contact time 8 2 1 0.8
1 mg/Z chlorine dioxide from sodium chlorite,
30 min. contact time 4 2 11
1 mg/t chlorine dioxide from sodium chlorate,
30 min. contact time * * * *
Granular Activated Carbon, replacement of sand,
on site reactivation 41 12 6 5
Polymeric Adsorbants (macroreticular resins, etc.) * * * *
Aeration, 30 to 1 air to water ratio
20 min. detention time 22 13 9 9
~Insufficient information available to calculate unit costs at this time.
33
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as chlorine replacements might themselves generate toxic residuals was
alluded to, but not discussed in detail, nor were any multimedia impacts.
Specifically, the need to regenerate spent carbon, and the possibility of
consequent emissions to air or water, were not addressed.
The recommended techniques, which were arrived at eliminating THM
precursors, were deemed to be preferable to removing the THMs themselves
after their formation. However, two techniques of chloroform removal were
also described: aeration and granulated carbon. In neither case was the
possibility addressed that use of these methods could cause chloroform
releases to air.
In 1977, the NAS released the report which had been commissioned by
the EPA, entitled, "Drinking Water and Health" (3). The report contained
brief summaries of toxicological and epidemiological data for 22 known or
suspected carcinogens, chloroform among them. The chief evidence cited for
carcinogenesis was the 1976 NCI study (Reference 3 in Section 5.2.7). NAS
estimated that the cancer risk to humans from TCE was 1.5 to 17.0 x 10 7Q,
where Q is the concentration of chloroform in parts per billion times the
average lifetime daily water consumption in liters. Human intake of chloro-
form from other media (air, food) was not considered in this estimate. The
study did note, however, that the Food and Drug Administration had just
banned chloroform as an ingredient in human drugs or cosmetics (see Section
5.2.8).
ODW proposed its Interim Primary Drinking Water Standards for
organic chemicals in February of 1978 (43 FR 5756). The proposal was split
into two parts, one dealing with the products of water treatment practices,
of which THMs were cited as the foremost example, and the other dealing with
chemicals "introduced as a result of point and non-point sources of pollution."
THMs were placed in the former category, as industrial sources of THM precur-
sors (such as chlorine) were assumed to be a minor factor. The proposal
called for an MCL of 0.1 mg/1, and did not specify the treatment methods to
be used in achieving that level. In support of this approach, ODW brought
th(= following factors:
1) Chloroform was shown to affect the central nervous
systems and livers of mammals, and to cause cancer in
laboratory animals. Epidemiological evidence of
34
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disease in humans caused by low environmental con-
centrations was inconclusive, but the potential for
harm after a lifetime of water consumption justified
the action.
2) Methods for controlling THMs were available, as docu-
mented in the Interim Treatment Guide (2), without
increasing microbiological contamination.
3) THMs represent the largest class of organic chemicals
present in drinking water.
In setting an MCL, the agency stressed that, as in the case of all carcino-
gens, no level of exposure could be considered "safe." Rather, the selected
level was supposed to balance public health considerations against techni-
cal and economic feasibility. The level of 0.1 mg/1 was chosen because it
represented a "likely concentration to be found at the tap of the average
consumer," but was considerably lower than the highest monitored levels,
which were around 0.8 mg/1. Thus, the MCL was chosen in order to avoid
excursions in THM levels, not to lower the mean. Human intake of chloroform
from media other than drinking water was not a factor in the selection of the
MCL, although the preamble mentioned ambient air and food as possible routes
of exposure. FDA's actions banning chloroform in drugs and cosmetics were
acknowledged, but the two recommended NIOSH workplace standards were not.
The cost of the proposed MCL was estimated to be $154.4 million (1976 dollars)
for capital expenditures plus $25.9 million annually for operating and
maintenance, for an annualized equivalent payment of $2.07 per person served
per year. The subsequent economic impacts of these costs, however, were not
addressed.
In preparation for its final rule, ODW commissioned a reworking of
the economic impact analysis. Produced by Temple, Barker & Sloane, Inc. in
September of 1979, it was entitled "Economic Impact Analysis of the Promul-
gated Trlhalomethane Regulation for Drinking Water" (4). The analysis
embodied several changes in the regulations, including incorporation of
small systems (10,000 to 75,000 customers) within the MCL requirement, and
relaxation of restrictions on the use of alternate disinfectants. In comput-
ing its cost estimates, great attention was paid to, a) judging how many of
systems in several size categories would use each of the several available
35
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treatment techniques; b) updated unit costs for treatment techniques; and c)
the sensitivity of the cost results to alternate assumptions regarding the
treatment techniques, the MCL itself, and the size cutoff for systems covered
by the rule. Despite the expansion of the rule to include small systems,
the new analysis resulted in significantly lower overall costs than had been
computed in 1977, mostly because a much higher percentage of affected systems
were assumed to use alternate disinfectants instead of granular activated
carbon to achieve compliance. The resulting costs were estimated to be $85
million (1980 dollars) for capital expenditures and $10 million annually for
operation and maintenance, resulting in an annualized cost of $0.70 per
person served per year; this latter is only a third of the previous estimate,
not including the effect that the more recent costs were expressed in terms
of slightly inflated dollars. The method and assumptions (interest rate,
depreciation period) by which the cost annualization was performed were not
given.
The final MCL for trlhalomethanes was published on 29 November 1979
(44 FR 68624). The MCL of 0.1 mg/1 was adopted unchanged, but its applica-
bility was extended to systems serving as few as 10,000 people. The preamble
mainly summarized EPA's responses to the 598 written comments which the
proposal received. But an extensive attachment, entitled "Statement of Basis
and Purpose for an Amendment to the National Interim Primary Drinking Water
Regulations on Trihalomethanes," recapitulated and expanded the technical
support for the action, and included the results of recent research. The
attachment provided significant new information in four areas: estimation
of total human exposure to THMs, consideration of epidemiological studies,
estimation of cancer risks, and cost-benefit tradeoffs.
With respect to human uptake of THMs, the attachment provided
estimates of exposures from (44 FR 68695) drinking water, air, and food
(Exhibit 5.13). At maximum exposure, drinking water was found to contribute
61 percent of the total body burden; at minimum exposure, the contribution
was only 23 percent. Eighteen retrospective epidemiological studies were
presented, relating water quality to cancer incidence rates. But the
quality of the data, the short time-span covered by the studies and the use
of correlation analysis led EPA to conclude merely that
When viewed collectively, the epidemiological studies
completed thus far provide evidence for maintaining a
36
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Exhibit 5.13
Human Uptake of Chloroform and Total Triholomethanes
from Drinking Water, Food, and Air
(Source: 45 FR 68695)
Exposure levels mg/year
Chemical
Mean (range)
Drinking
water
Food
Air
Chloroform
64
(0.73-343)
(2-15.97)
20
(0.41-204)
Tr ihalomethanes
85
(0.73-572)
37
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hypothesis that there may be a health risk and that
the positive correlations may be due to an association
between some constituents of drinking water and cancer
mortality.
The cancer ride estimate made by the NAS in 1977 (Ref. 1) was supplemented
with the results of the EPA Office of Water Planning and Standards' Water
Quality Criteria Document (Reference 3 in Section 5.2.2). Using the WQC
-4
assumptions, ODW computed a relatively high cancer risk rate of 4 x 10
resulting from a THM concentration of 0.1 mg/1 in drinking water. In defense
of its MCL, therefore, EPA declared the 0.1 mg/1 level to be "the initial
step in a phased regulatory approach" and stated that the standard would
become more restrictive as health data and control technologies improved.
Furthermore, and consistent with ODW's statement in the proposed rule that
technical practicality was a factor in setting the MCL, the attachment
presented the results of a computation showing that the maximum net benefit
would occur at an MCL of approximately 0.1 mg/1. This result is shown in
Exhibit 5.14.
The possible impacts of the drinking water rule on other media were
not a direct factor in setting the MCL, but ODW did consider some of them in
its responses to comments on the proposed rule. The chief concern raised was
over the possibility of air pollution resulting from the use of granular
activated carbon (GAC) to achieve the mandated THM levels.* ODW expressed
the opionin that air pollution from GAC regeneration ovens would be minimized
by the use of scrubbers, and that the resulting impacts would be negligible.
5.2.3.2 Underground Injection Control
Current Status of Action
Part C of the Safe Drinking Water Act, 42 USC 300h et. seq.,
requires EPA to promulgate minimum requirements for state programs to pro-
tect underground drinking water sources from contamination due to pollutants
*In fact, ODW had previously addressed these issues, not in connection with
trihalomethanes but in connection with its proposed rule requiring GAC
treatment for synthetic organic compounds (see, for example, 43 FR 29135).
A discussion of the proposed GAC rule is contained in the Trichloroethylene
case study (Section 2.2.3.1).
38
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Exhibit 5.14
Benefits vs. Costs for Alternate Total Trihalomethane
Minimum Concentration Levels
(Source: 44 FR 66705)
MillIons
1900 Dollars
100
80
Benefi t
Cancer Cases
Avoided @
$ 200,000/case
60
40
20
Pop. Cut-off « 10,000
Dene
Cost
105 ug/1
Maximum
Den
Mill ions
1900 Dollars
100
60
60
40
20
Coat
Revenue
Requirement
Potential MCL's
(ug/1)
-------
injected into wells. EPA is authorized by 42 USC 300h to promulgate a list
of those states for which an underground injection control (UIC) program "may
be necessary to assume that underground injection will not endanger drinking
water sources," to which EPA has responded by listing all states, the District
of Columbia and all territories and possessions.
Technical requirements and criteria are contained in 40 CFR Part
146. No underground injection can occur except by rule or by permit, and
five classes of underground injection wells are identified for regulation.
The classes most relevant to control of toxic wastes are: Class I: wells
used to inject hazardous wastes, as defined in 40 CFR 261.3, which includes
chloroform; other than Class IV wells, and certain other industrial and
municipal disposal wells; and Class IV: wells used to dispose of hazardous
or radioactive wastes into a formation which within one quarter mile of the
well contains an underground source of drinking water. No Class I well shall
be authorized if it results in movement of fluid into underground sources of
drinking water (USDW). New Class IV wells injecting hazardous wastes into
USDW's are to be prohibitied, and existing wells are to be phased out over a
six month period. No Class IV well shall be authorized if it results in
contaminants entering USDW which may adversely effect public health or cause
a violation of any NIPDWS. Certain wells are exempted from regulation,
however, including domestic cesspools and septic systems.
Multimedia Considerations in the Regulatory History
The development of the UIC program has been discussed in the Lead
case study, to which the reader is referred (Section 1.2.4.2). The designa-
tion of chloroform as a hazardous waste subject to the UIC program is
discussed below in Section 2.2.4, in connection with the hazardous waste
requlations promulgated under RCRA.
40
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References for Section 5.2.3
National Cancer Institute, "Report on Carcinogenesis Bioassay of
Chloroform," March 1, 1976.
USEPA, Office of Research and Development, "Interim Treatment Guide
for the Control of Chloroform and Other Trihalomethanes,"
June, 1976.
National Academy of Sciences, "Drinking Water and Health," Washington,
D.C., 1977.
USEPA, Office of Drinking Water, "Economic Impact Analysis of the
Promulgated Trihalomethane Regulation for Drinking Water," EPA-
520/9-79-022, September, 1979.
41
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5.2.4 Office of Solid Waste (OSW)
5.2.4.1 Hazardous Waste Management System
A full discussion of the hazardous waste management system authorized
by RCRA has been presented is in the Lead case study (Section 1.2.5). It
includes a description of the following components 1) identification and
listing mechanism for hazardous wastes, 2) standards for generators, 3)
standards for transporters, and 4) standards for owners and operators of
treatment, storage, and disposal facilities for hazardous waste.
Hazardous wastes containing chloroform are subject to regulation
under RCRA's Hazardous Waste Management System via four identification and
listing routes. The first is through chloroform's listing in 40 CFR 261
(Appendix VIII) as a toxic waste constituent. Another is through chloro-
form's inclusion as one of the 65 toxic pollutants under the CWA, Section
307. Chloroform is also specifically listed for regulations pertaining to
discarded commercial chemical products, off-specification species, containers,
and spill residues thereof (40 CFR 261.33). Lastly, chloroform is included
in eight waste streams in the regulation's list of hazardous wastes from
specific sources (40 CFR Part 261.31). The eight waste streams include the
following:
1) Distillation bottoms from the production of acetaldehyde
from ethylene.
2) Distillation sidecuts from the production of acetaldehyde
from ethylene.
3) Heavy ends or distillation residues from the production
4) Heavy ends from the distillation of ethylene dichloride in
ethylene dichloride production.
5) Heavy ends from the distillation of vinyl chloride monomer
production.
6) Aqueous spent antimony catalyst waste from fluoromethanes
production.
7) Spent catalyst from the hydrochlorinator reactor in the
production of 1,1,1-trichloroethane.
8) Waste from the product stream stripper in the production
of 11,1-trichloroethane.
42
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Multimedia Considerations
Congress intended the hazardous waste management system under RCRA
to have a very broad scope. Consequently, regulations under RCRA are
process oriented rather than pollutant-oriented because of the wide variety
of hazardous waste stream constituents in existence.
Chloroform qualifies as a hazardous waste individually as well as a
constituent of certain industrial waste streams. The industrial survey
background document (1) analyzed the following five industries that produce
wastes containing chloroform:
1) Acetaldehyde Production
2) Carbon Tetrachloride Production
3) Ethylene Dichloride and Vinyl Chloride Monomer
4) Fluorocarbon Production
5) Trichloroethane Production
The background document's acetaldehyde production profile briefly
described the industry as a whole, typical manufacturing processes, and
the composition and management of wastes. In a list of waste constituents,
chloroform was mentioned under "other organics." (See exhibit 5.15.) No
attempt was made to estimate the amount of chloroform that would be con-
trolled on a national basis by regulation of this wastestream. Typical waste
management techniques for this industry were deep well injection and lagoons.
The document noted that chloroform is capable of 1) migrating and persisting
in ground water and 2) volatilizing into the atmosphere. In addition, EPA
found that chloroform was persistent and likely to contaminate drinking water
supplies if uncontrolled. Volatilized chloroform was found to decompose
under sunlight into carbon tetrachloride and phosgene, which were charac-
terized as a carcinogen and a toxic gas respectively. No calculations of air
emissions or groundwater migration rates were included in the brief discus-
sion .
The background document profile also characterized chloroform's
toxic and ecological effects. EPA described chloroform as having a high
carcinogenic potential in humans. This high potential was supported with
chloroform's designation as a priority pollutant, the National Cancer
43
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Exhibit 5.15
Uncontrolled Waste Discharge Ratio
(Units m g per kg of acetaldehyde;
Source: Reference 1)
Component
Formula
Distillation
Bottoms
(Discharge Distillation
Wastewater) Side-Cut Combined *>
Ethylene
c2h4
—
—
—
Acetaldehyde
C2H4O
-
7.8
7.8
Acetic Acid
C2H4O2
13.9
0.6
14.5
Chloroacetaldehyde
C2H3OCI
-
5.5
5.5
Acetyl chloride
C2H3OCI
4.2
5.0
9.2
Chloral
C2HOCI3
2.1
3.4
5.5
Paraldehyde
(C2H40)3
1.6
-
1.6
Other organics (including chloro-
4.0
2.0
6.0
form, formaldehyde and methylene
and methyl chloride)
Water
TOTAL Volatile Organics
H20
TOTAL STREAM:
25.8
795.6
821.4
24.3
25.5
49.8
50.1
821.1
871.2
*>These totals are combined because combination of the two waste streams
is a known method disposal. (4)
44
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Institute's Bioassay of Chloroform of 1976, and EPA's CAG Type
II Risk Assessment in 1979. Besides chloroform's carcinogenicity, the
brief description noted chloroform's acute toxicity and its ability to
cause neurological damage with chronic exposures.
The OSHA Threshold Limit Value of 50 ppm was (mistakenly)
stated to be the only existing regulatory action on chloroform.
The background document profiles of the other four industries were,
for the most part, a repetition of the information provided in the first
profile. However, descriptions of chloroform's toxic and ecological
effects did vary among the five profiles. For instance, the EPA noted in
one that chloroform was found to be bioaccumulative in fish by a factor of
fourteen. In addition, other profiles referenced several other regulatory
efforts concerning chloroform that were not included in the first profile.
Other regulatory efforts included the following:
• FDA's prohibition of chloroform in drugs, cosmetics
and food contact materials.
• On-going investigations in EPA'a Office of Water and
Waste Management, Office of Air, Radiation and Noise,
and Office of Toxic Substances.
The hazardous waste management system regulations themselves did
not specifically mention chloroform. They did, however, treat specific
issues that concern chloroform as a volatile organic compound (VOC). EPA's
regulations under RCRA for VOC's are discussed in the formaldehyde case
study (see section 6.2.3).
EPA proposed to revise the interim final rule of 19 May 1980 (45 FR
3119) on 5 February 1981 (46 FR 11127). The proposed revision would prohibit
chloroform from being discharged into present or future drinking water
supplies. Chloroform, in the form of pesticides, and other hazardous waste
constituents were prohibited because of their listing in the Interim Primary
Drinking Water Regulations.
*The document was unclear and inconsistent in presenting other regulatory
actions that applied to chloroform. It mistakenly referred to time
weighted average (TWA) instead of threshold limit value (TLV). The
document further confused the issue by alternately referring to 2 ppm and
50 ppm as OSHA's single standard for chloroform. The 50 ppm standard is
OSHA's TLV and the 2 ppm standard is NIOSH's recommended level for chloro-
form as an anesthetic ( see OSHA's section 5.2.7).
45
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The revisions concerned informational and procedural requirements, not the
permitting standards applicable to owners and operators of hazardous waste
land disposal facilities. The latter standards remained the same as those
proposed on 19 May 1980. No new background documentation was generated
for this proposed rule.
References for Section 5.2.4
1. Environmental Protection Agency, "Subtitle C - Background Document
For Identification and Listing of Hazardous Wastes: 40 CFR Part
261.31 and 261.32," April, 1980.
46
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5.2.5
Office of Pesticide Programs (EPA/OPP)
5.2.5.1 Registration of Pesticides
Current Status of Action
On 6 April 1976 (41 FR 14588), pursuant to the procedures set forth
in 40 CFR 162.11, a Notice of Rebuttable Presumption Against Registration
(RPAR) was issued for pesticide products containing chloroform. Under 40 CFR
162.11 the RPAR was triggered when chloroform was found to meet or exceed
EPA's oncogenic risk criterion.
The RPAR on chloroform may be rebutted by showing that it "will not
concentrate, persist or accrue to levels in man or the environment likely to
result in any significant chronic adverse affects" or that the OPP risk
criteria determination was in error (40 CFR 162.11). In addition, the
registrant may submit evidence that the benefits of the pesticide outweigh
the risk (40 CFR 162.11). All comments, evidence, etc. were to have been
submitted by 23 July 1976.
Multimedia Considerations in the Regulatory History
The brief Federal Register notice announcing the RPAR contained a
paragraph describing the 1976 National Cancer Institute bioassay (Reference
3 in Section 5.2.7) as the sole basis for OPP's action. No consideration was
given to the amounts of chloroform used as pesticides, the degree of human
exposure, the health benefits of the cessation of registration, or the
diffusion of chloroform into various media. EPA is presently conducting a
risk/benefit analysis, and will propose a course of action in 1981.
47
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5.2.6 Office of Water Program Operations (EPA/OWPO)
5.2.6.1 Ocean Dumping Criteria
Current Status of Action
Section 102(a) of the Marine Protection, Research and Sanctuaries
Act authorizes the Administrator of EPA to issue ocean dumping permits if
such dumping will not degrade or endanger human health, welfare, or amenities,
or the marine environment, or economic potential. In 1973 and again in 1977,
the Office of Water Program Operations promulgated criteria to which permitted
dumping operations must adhere. Major provisions which affect the disposal
of chloroform are:
• A prohibition on dumping organohalogens, mercury, and
cadmium compounds except as "trace contaminants" (40
CFR 227.6}.
• A prohibition on dumping known or suspected carcinogens,
mutagens, and teratogens {40 CFR 227.6).
However, chloroform is not mentioned in the regulations, and it appears that
if any control over its disposals exists, it is exercised on a case-by-case
basis when disposers apply for ocean dumping permits.
Multimedia Considerations in the Regulatory History
The current ocean dumping criteria were proposed on 28 June 1976
(41 FR 26644) and promulgated in final form on 11 January 1977 (42 FR 2476).
The most complete guide to the applicability and rationale behind the criteria
is the "Final Environmental Impact Statement - Proposed Revisions to Ocean
Dumping Criteria" (1). No multimedia discussion was included in this EIS.
Indeed, no data on sources of flows of specific chemicals was included at
all. Furthermore, it is doubtful whether the action was intended to have any
effect on chloroform dumping specifically. The EIS states in several places
that the reason for prohibiting dumping of organohalogens is the concern over
persistent synthetic compounds such as DDT and PCB's; chloroform is much less
persistent than these chemicals. Dumping of chloroform is controlled in
principle under the prohibition, which allows it to be discharged only as a
trace contaminant of other wastes. The effective definition of "trace
contaminant" is that concentration which, after initial mixing, does not
48
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exceed the marine water quality criterion (Part 22+.6(c) (1)). But there is
no marine water quality criterion for chloroform, because OWRS considered the
toxicological data for saltwater organisms to be inadequate (see Reference 3
in Section 5.2.2).
Chloroform may eventually be controlled under the provision prohi-
biting the dumping of known or suspected carcinogens, but there is no record
of a determination by the Administration that chloroform is in this category.
References for Section 5.2.6
1. U.S. Environmental Protection Agency, "Proposed Revisions to Ocean
Dumping Criteria - Final Environmental Impact Statement,"
31 January 1977.
49
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5.2.7
Occupational Safety and Health Administration (OSHA)
5.2.7.1 Occupational Exposure to PCBs
Current Status of Action
OSHA limits the concentration of chloroform in workplace air to a
ceiling value of 50 ppm, or 240 mg/m^ (Table 7-1, 29 CFR 1910.1000). This
limit was derived from the Threshold Limit Values specified by the American
Conference of Government Industrial Hygienists (ACGIH) in 1968. No inde-
pendent rule-making has been initiated by OSHA.
Multimedia Considerations in the Regulatory History
The Occupational Safety and Health Act, which became effective on
28 April 1971, required the Secretary of Labor to adopt as mandatory any
national consensus standard or any established Federal standard relating to
employee health and safety (Section 6(a)). Within a month, OSHA had adopted
the Threshold Limit Values for airborne contaminants which the ACGIH, a
private standard-setting organization, had published in 1968 (36 FR 10466).
TLVs were specified for chloroform, as described above.
The ACGIH documentation of its TLVs (1) shows that the 1968 values
were derived on the basis of protecting workers from central nervous system
depression and damage to the liver and kidneys. In 1976, the ACGIH revised
tis TLV to 10 ppm (approximately 50 mg/m^) on an 8-hour time-weighted
average basis. This was done because of evidence published that year (and
reviewed below) showing chloroform to be carcinogenic in several strains of
rats and mice. But because OSHA's adoption of consensus standards terminated
in 1971, the revised TLV has not been incorporated into that agency's regula-
tions. Therefore, the present OSHA concentration limit is excessive by at
least a factor of five, according to the NIOSH determination.
In 1974, the National Institute of Occupational Safety and Health
(NIOSH) issued a Criteria Document for occupational exposure to chloroform.
The recommended standard limited workplace concentrations to 10 ppm on a
10-hour time-weighted average basis, with a 10-minute maximum of 50 ppm. The
toxicological evidence cited in support showed damage to the central nervous
system, liver and kidneys in exposed humans to be the major concerns. One
study from 1945 as cited that produced tumors in mice having prior liver
50
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necrosis; but the relevance of this result to occupational exposures was not
clear, and further study of carcinogenicity was recommended. Only the
workplace environment was considered in setting a recommended standard;
industries specifically mentioned included the manufacture of chloroform and
pharmaceuticals, but the report implied that the chemical was found in other
places as well. The total number of workers "potentially exposed" was stated
to be approximately 80,000, but neither derivation nor distribution by
exposure level or industry were given. The only item which showed concern
for other media was a recommendation on handling of spills, to the effect
that "sewering of chloroform should be done in compliance with local, state,
and federal waste disposal regulations."
The National Cancer Institute (NCI) published a carcinogenesis
bioasssay of chloroform in 1976 (3). The study was entirely experimental in
nature, and did not concern itself with chloroform in the environment or its
effects on humans. The experimenters found that rats fed chloroform developed
kidney epithelial tumors, and mice similarly treated developed hepatocellular
carcinomas. In both cases, the incidence of tumors increased with increasing
dose.
NCI's results were mentioned in a second NIOSH Criteria Document
issued in 1977 (4). This one dealt with waste anesthetic gases, of which
chloroform is one. Although the scope of the document was limited to only a
small subset of working environments (i.e., operating rooms and medical
offices), it was the first NIOSH publication to acknowledge chloroform's
carcinogenicity. Fetotoxicity in animals was also noted. The epidemio-
logical studies cited dealt with groups of medical professionals exposed to
many anesthetics over long periods of time. Although significant increases
in liver disease and reproductive abnormalities were observed, the role of
chloroform alone in producing these effects cannot be determined from the
studies. The Criteria Document recommended that chloroform, when used as an
anesthetic, should be limited to an airborne concentration of 2 ppm (corres-
ponding to 9.76 mg/m^).
To date, OSHA has not initiated action on any of NIOSH's recom-
mendations. It is possible that the agency may decide to regulate the
substance under its current rule governing occupational carcinogens (29 CFR
1990), but chloroform was not included on OSHA's first list of candidate
substances (45 FR 53672).
51
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References for Section 5.2.7
American Conference of Government Industrial Hygienists, "Documenta-
tion of the Threshold Limit Values for Substances in Workroom
Air," 1977.
National Institute for Occupational Safety and Health, "Criteria for
a Recommended Standard: Occupational Exposure to Chloroform,"
75-114, 1974.
National Cancer Institute, "Report on Carcinogenesis Bioassay of
Chloroform,n 1 March 1976.
National Institute of Occupational Safety and Health, "Criteria for
a Recommended Standard: Occupational Exposure to Waste Anesthetic
Gases and Vapors," 77-140, March 1977.
52
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5.2.8 Food and Drug Administration
5.2.8.1 Adulterated and Misbranded Food and Drugs
Current Status of Action
FDA has banned chloroform as an ingredient (active or inactive) in
any human or animal drug or any cosmetic product, except in residual amounts
resulting from the manufacturing process (21 CFR 310.513, 510.413 and 700.18
respectively). *
The agency has proposed (41 FR 15029) to ban the use of chloroform
as a component of food-contact articles, and to list it as a substance
prohibited from use in human food, under Section 409(c)(3)(A) of the FFDCA
(the "Delaney clause"). No final action on this proposal has yet been
taken.
Multimedia Considerations in the Regulatory History
On 9 April 1976 FDA proposed to declare human drugs containing
chloroform to be "misbranded," and cosmetics containing the substance to be
"adulterated," as described above (41 FR 15026). At the same time, the
agency proposed to delete chloroform from the regulations allowing certain
substances in food-contact articles, and to prohibit the chemical from use in
human food. Existing stocks of these products, however, would not have to be
removed from the market. Brief statements of justification were provided
with each proposal. These cited the 1976 NCI bioassay (Reference 3 in
Section 5.2.7) as the basis for the actions, but contained no other discussion
of chloroform's health effects or occurrence in the environment. This
proposal has never been made final, and no schedule for promulgation has been
issued.
*The precise regulatory terminology used by FDA is worth noting. Human and
animal drugs containing chloroform were ruled to be "new drugs within the
meaning of Section 201 of the [Federal Food, Drug and Cosmetic] act," even
if they had been in existence for many years, and they were further ruled to
be "misbranded." With respect to cosmetics, chloroform was deemed to be a
"deleterious substance," thus causing cosmetics containing it to be considered
"adulterated" under Section 601(a) of the act. The findings of "misbranded
and "adulterated" trigger various regulatory provisions of the FFDCA,
notably Section 301 which prohibits the manufacture and distribution
in interstate commerce of adulterated or misbranded foods, drugs, devices,
and cosmetics.
53
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The proposed ban on chloroform in human drugs and cosmetics was
made final in June of 1976 (41 FR 26842). The provisions were modified to
allow chloroform to exist in such products if it was the unavoidable residue
of the manufacturing process. The brief preamble to the final rule dealt
mostly with the validity of the NCI bioassay as an indicator of human health
risk; no new information was presented.
In November of 1976 FDA proposed a similar ban on animal drugs (41
FR 52482). In support, the preamble cited, in addition to the NCI bioassay,
several studies submitted by the Cosmetic, Toiletry and Fragrance Association
which showed an association between chloroform-bearing toothpaste and cancer
in some laboratory mammals (but not in humans). The FDA concluded that a ban
was justified because of the possible risk to people administering the drugs,
and the possibility that a chloroform residue would remain in the treated
animals. The rule was made final, with no changes or additional discussion,
in September of 1977 (42 FR 44226).
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5.2.9 Department of Transportation (DOT)
5.2.9.1 Hazardous Materials Regulations
Current Status of Action
Pursuant to the Hazardous Materials Transportation Act, the Depart-
ment of Transportation has promulgated rules governing the transporters of
hazardous materials. The rules require that shippers and transportation of
hazardous materials (as defined in 49 CFR 172.101) adhere to standards for
containing, packaging and labeling such materials and for maintaining mani-
fests and documentation (49 CFR 171-177). Amendments to the rules were
promulgated on 22 May 1980 (45 CFR 34560) which add to the hazardous materials
table the hazardous substances and hazardous wastes regulated by EPA (40 CFR
116 and 262 respectively). Further provisions were added requiring transpor-
ters to notify the appropriate Federal agency of any discharges of hazardous
wastes and hazardous substances (49 CFR 171.16, 117.17). The revised Hazar-
dous Materials Table, published as 49 CFR 172.101, includes chloroform.
Multimedia Considerations in the Regulatory
The revised Hazardous Material Transportation regulations were
issued concurrently with EPA's issuance of Standards for Transporters of
Hazardous Wastes under Subtitle C of RCRA (45 FR 33150). EPA's rules have
the effect of supplementing the DOT reporting requirements for hazardous
waste spills with a stipulation that the transporter responsible must clean
up the discharged wastes. No background documentation was issued in support
of DOT's amended rules, and there is no evidence that multimedia factors
were considered in their promulgation.
55
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APPENDIX
Federal Register Notices Reviewed for
Chloroform Case Study
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CHEMICAL: Chloroform
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 [JSC s1251 et. seq.
PROGRAM: New Source Performance Standards, Section 306, 33 USC 1316
40 CFR Parts 402-699
FR/DATE
CFR
ACTION
DESCRIPTION
46 FR 1430
1/6/81
40 CFR
Part 430
Proposed
Rule
Proposed NSPS for Pulp,
Paper and Paperboard
Point Source Category
(subparts F-K, P, Q and U)
including limitation on
chloroform in wastewater
discharges
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CHEMICAL: Chloroform
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC s1251 et. seq.
PROGRAM: Designation of Hazardous Substances and Reportable Quantities;
s311(b)(2)(A), 33 USC s1321(b)(2)(A); 40 CFR Parts 116, 117
FR/DATE
CFR
ACTION
DESCRIPTION
46 FR 59960
12/30/75
43 FR 10474
3/13/78
40 CFR
Part 116
40 CFR
Part 116
Proposed
Rule
Final Rule
Proposed list of hazar-
dous substance, includ-
ing chloroform
List of hazardous sub-
stances, including
chloroform
44 FR 10270
2/16/79
40 CFR
Part 117
Proposed
Rule
Reportable quantities
(RQ) for hazardous sub-
stance discharges pro-
posed, including RQ of
5,000 lbs. for chloroform
44 FR 50766
8/29/79
40 CFR
Part 117
Final Rule
Reportable quantities
for hazardous substance
discharges, including RQ
of 5,000 lgs. for chloro-
form
45 FR 46097
7/9/80
40 CFR
Part 117
Proposed
Rule
Proposed reduction of
RQ for chloroform from
5,000 lbs. to 100 lbs.
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CHEMICAL: Chloroform
AGENCY: EPA
STATUTE: Water Pollution Control Act, 33 USC s1251 et. seq.
PROGRAM: Toxic Pollutant Effluent Standards; s307(a)(1),
33 USC s1317(a)(1)? 40 CFR Parts 129, 401
FR/DATE
CFR
ACTION
DESCRIPTION
43 FR 4109
1/31/78
Notice
List of toxic pollutants
published pursuant to
s307(a)(1)
44 FR 44501
7/30/79
40 CFR
s401.15
Final Rule
List of toxic pollutants
relisted at 40 CFR s401.15
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CHEMICAL: Chloroform
AGENCY: EPA
STATUTE: Water Pollution Control Act, 42 USC s1251 et. seq.
PROGRAM: Water Quality Standards and Criteria; Sections 303, 304(a),
33 USC 1313, 1314(a); 40 CFR Parts 120
FR/DATE
CFR
ACTION
DESCRIPTION
44 FR 1592 6
3/15/79
Notice
Notice of availability
for public comment of water
quality criteria for 27 of
the 65 toxic pollutants,
including chloroform stand-
ards for fresh and salt water
aquatic life and human health
45 FR 79318
11/28/80
Notice
Notice of availability of
water quality criteria
documents, including chloro-
form standards for fresh
and salt water aquatic life
and human health
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CHEMICAL: Chloroform
AGENCY:
EPA
STATUTE: Safe Drinking Water Act, 42 USC ss300f et seq.
(amending Public Health Service Act, 42 USC ss201 et seq.)
PROGRAM: National Interim Primary Drinking Water Standards; ss1401, 1412,
1414, 1445, 1450, 42 USCR ss300f, 300g-1, 300g-3, 300]-4, 300]-9;
40 CFR Parts 141, 142
FR/DATE
40 FR 11990
3/14/75
CFR
40 CFR
Part 141
ACTION
Proposed
Rule
DESCRIPTION
Proposing interim primary
drinking water standards,
including a maximum contam-
inant level (MCL) for carbon-
chloroform extract (CCE)
40 FR 59566
12/24/75
40 CFR
Part 141
Final Rule
Establishing interim primary
drinking water standards,
but dropping MCL for CCE
41 FR 28991
7/14/7 6
40 CFR
Part 141
Advance Notice
of Proposed
Rulemaking
Announcement that EPA is
developing regulatory stra-
tegies for the control of
organic chemicals in drink-
ing water
43 FR 5756
2/9/78
40 CFR
Part 141
Proposed
Rule
Proposed maximum contaminant
level (MCL) for trihalome-
thanes (including chloro-
form) and associated
monitoring and reporting
requirements
43 FR 29135
7/6/78
40 CFR
Part 141
Supplemental
Proposed
Rule
Additional documentation
for above proposed rule
44 FR 42775
7/2 0/79
Notice
Notice of memorandum of
understanding between EPA
and FDA: EPA will regulate
additives to drinking water
under SDWA, TSCA and FIFRA;
FDA will regulate additives
in water used for food and
in bottled water under FFDCA
44 FR 68 624
11/29/79
40 CFR
Part 141
Final Rule
MCL of 0.10 mg/1 established
for tribalomethanes (includ-
ing chloroform), but only for
community water systems serv-
ing a population of greater
than 10,000; monitoring and
reporting requirements also
established. Effective date
delayed two years for large
communities, four years for
small.
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CHEMICAL: Chloroform
AGENCY: EPA
STATUTE: Resource Conservation and Recovery Act, 42 USC s6901 et. seq.
PROGRAM: Hazardous Waste Management System, Sections 1006, 2002(a),
3001-7, 3010, 7004; 42 USC ss6905, 6912(a), 6924-25;
40 CFR Parts 260-65
FR/DATE
CFR
ACTION
DESCRIPTION
45 FR 33119
5/19/80
40 CFR
Part 2 61
Interim
Final Rule
Lasting of hazardous
wastes; chloroform listed
as a toxic waste (40 CFR
s.261 .33 [f] ), as a hazardous
constituent (40 CFR, Part
251, App. VIII), and as the
basis for listing certain
specific sources as hazar-
dous (40 CFR Part 2 61,
App. VII)
45 FR 74884
11/12/80
40 CFR
Part 2 61
Final Rule
Final listing of hazardous
constituents (40 CFR Part
261, Apps. VII and VIII)
45 FR 78532
11/2 5/80
40 CFR
Part 2 61
Final Rule
Final listing of toxic
wastes (40 CFR ss.2 61 .33[f] )
46 FR 11127
2/5/810
40 CFR
Part 2 64
Proposed
Rule
Proposed standards for hazar-
dous waste facilities, includ-
ing prohibition on discharg-
ing chloroform into present
or future drinking water
sources (40 CFR s.2 64 . 20 [b] )
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CHEMICAL: Chloroform
AGENCY: EPA
STATUTE: Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
(as amended by the Federal Environmental Pesticide Control
Act (FEPCA)), 7 use 13 6 et seq.
PROGRAM: Pesticide Registration, 40 CFR Part 162
FR/DATE CFR
41 FR 14588 40 CFR
4/6/7 6 Part 162
ACTION DESCRIPTION
Notice Notice of rebuttable
presumption against con-
tinued registration of
pesticide products contain-
ing chloroform
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CHEMICAL: Chloroform
AGENCY: OSHA
STATUTE: Occupational Safety and Health Act of 1970, 29 USC ss651-78
PROGRAM: Limitations for Toxic and Hazardous Substances in Workplace Air;
s6(a) and (b), 29 USC s655(a) and (b)(5); 29 CFR Part 1910
FR/DATE
CFR
ACTION
DESCRIPTION
36 FR 10466
5/29/71
29 CFR
1910.93,
Table G-1
Final Rule
Promulgation of National
Consensus Standards for
workplace exposure to
air contaminants, including
50 ppm PEL for chloroform
40 FR 23072
5/28/75
29 CFR
1910.1000
Table Z-1
Above standards recodified
at 29 CFR 1910.1000, Table
Z-1
42 FR 54169
10/4/77
29 CFR 1990
Proposed
Rule
Identification; classifi-
cation, and regulation of
occupational carcinogens.
Includes NIOSH list showing
chloroform as a suspect
carcinogen to be considered
for classification and
regulation
42 FR 5002
1/22/80
29 CFR 1990
Final Rule
Identification; classifi-
cation, and regulation of
occupational carcinogens
45 FR 53 673
8/12/80
29 CFR 1990.121 Notice
Publication of Candidate
Substance List to be used
in priority setting.
Chloroform not included
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CHEMICAL: Chloroform
AGENCY: DOT
STATUTE: Hazardous Materials Transportation Act, 49 USC 1801 et seq.
PROGRAM: Materials Transportation Bureau
FR/DATE
CFR
ACTION
DESCRIPTION
45 FR 34560
5/22/80
49 CFR
Part 172
Final Rule
Regulations for the
packaging, labelling and
shipping of hazardous
materials, including chloro-
form at 49 CFR 172.101,
table of hazardous materials,
and at 49 CFR 172.102,
optional hazardous materials
table
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CHEMICAL: Chloroform
AGENCY: FDA
STATUTE: Federal Food, Drug and Cosmetic Act, 21 USC s301 et seq.
PROGRAM:
FR/DATE
CFR
ACTION
DESCRIPTION
41 FR 15026
4/9/7 6
41 FR 15029
4/9/7 6
21 CFR
Parts 310
and 700
21 CFR
Part 121
Proposed
Rule
Proposed
Rule
Proposal ban on case of
chloroform in drug and
cosmetic products
Proposal deletion of pro-
visions allowing use of
chloroform as a component
of food-contact articles
and proposed ban on use
in human food
41 FR 2 684 2
6/29/7 6
41 FR 52482
11/30/76
21 CFR
Parts 310
and 700
21 CFR
Part 510
Final Rule
Proposed
Rule
Final rule banning use of
chloroform in drug and
cosmetic products
Proposal ban on use of
chloroform in animal drugs
(i.e. to treat risk drugs
as unsafe, adulterated or
misbranded)
42 FR 44225
9/2/77
21 CFR
Part 510
Final Rule
Final rule banning use of
chloroform in animal drugs
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