B14X
/
V
CHLORINATED SOLVENTS INTEGRATION REPORT COMMITTEE
FINAL REPORT
1st July 1986
HEADQUARTERS LIBRARY .
CNVIRONMENTAL PROTECTION AGENCY
";ASH!NGTON, D.C. 20460
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I. INTRODUCTION
This document is a follow-up to the Reporton the
Feasibility of an Integrated Regulatory Investigation of
Chlorinated Solvents (Feasibility Study), dated 26th February
1986. That study evolved from an EPA investigation of ^metjijdj
chloride undertaken in cooperation with other Federal agencies
-and announced in an Advance Notice of Proposed Rulemaking
(17th October 1985, 50 FR 42637). As that investigation
proceeded, the interchangeability of methylene chlorj.de with
other toxic chlorinated solvents, together with their cross-media
potential, suggested that these solvents should be addressed as a
group rather than individually and in an integrated manner under
relevant statutory authorities.
/^ Given this situation, the Feasibility Study recommended:
^' f (1)1 an immediate integrated interagency regulatory investigation '
^of/the risks posed "by six majnj^ gfrl nrinated solvents—in four
major exposure source categories, so as to initiate prompt and
effective action on a significant part of the overall problem
(this investigation is referred to as the Development Plan
effort); and (2) an assessment of all other current activities
designed to address chlorinated solvents problems not handled
under the four major exposure source categories and whether these
activities should be coordinated or integrated.
The Feasibility Study further recommended that a Program
Management Committee be established to oversee the development of
these two reports and that an Integration Report Committee (IRC)
be created and given the responsibility for performing the
assessment described in the second recommendation. This report
is a result of the Integration Report Committee's efforts to
assess the need to further coordinate or integrate chlorinated
solvents activities not considered under the Development Plan.
This report is primarily the result of work by
representatives of OSHA and several EPA offices (see Annex.I).
Committee participation by CPSC and FDA was limited.
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II. BACKGROUND
A. General Background
This report focuses on six chlorinated solvents:
methylene chloride, trichloroethylene, perchloroethylene, carbon
tetrachloride, methyl chloroform, and CFC-113. . There is a wide
range of activities that produce, use, or dispose of these
chlorinated solvents, and the range of regulatory activity
dealing with these activities mirrors this breadth. This
regulatory interest springs from the fact that four of the six_
solvents (methylene chloride, trichloroethylene, "^
perchloroethylene, and carbon tetrachloride) are considered
Probable Human Carcinogens by EPA, all six present siai^ifTcant
non-carcindgenic ne^itn hazards, and three ~of the six contribute
'ospneric ozone depletion.
All six of these chemicals are produced in fairly high
quantities: />
Solvent
Carbon Tetrachloride
Methyl Chloroform
Methylene Chloride
Perchloroethylene
Trichloroethylene
CFC-113
Tc.;
&
U.S. Production
1984 (pounds)
714,000,000
677,000,000
606,000,000
573,000,000
209,000,000
150,000,000
The current use of these solvents in exposure sources
where risk has been estimated results in about 23,000 total
estimated excess lifetime (40 years for occupational exposures
and 70 years for ambient exposures) cancer cases (between 300 and
500 annually). While most of these cases (about 85 per cent) are
expected to result from the four major use categories covered by
the Development Plan (metal cleaning, dry cleaning, aerosols, and
paint stripping), there are many uses where risk has not been
quantified. Because of these unestimated risks, these estimates
probably understate the total cancer incidence resulting from the
use .of these solvents.
jFpur of the solvents (carbon tetrachloride, methylene
chloride, perchloroethylene, and trichloroethylene) have been
classified as Probable Human Carcinogens bv EPA under its
"Proposed Guidelinesfor Carcinogen RiskAssessment. Depending
upon the exposure concentration, these solvents also pose a range
of non-cancer acute and chronic risks to humans, including
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cardiovascular damage/ central nervous system dsyfunction, liver
and kidney damage, and reproductive abnormalities. In addition,
CFC-113, methyl chloroform, and carbon tetrachloride are believed
to contribute to stratospheric ozone depletion, which in turn is
believed to result in excess skin cancers and adverse climatic
changes. A bioassay for carcinogenicity is planned by the
National Toxicology Program (NTP) for methyl, chloroform.
There__£xists in certain uses potentially extensive-
inter cTTangeabilitv among these soj-yent-.fi. Thus, if regulation of
one solvent prevented its use for a particular application, or
raised its cost sufficiently, another might be substituted.
Other chlorinated and non-chlorinated solvents could also be
substituted. The unregulated or under-regulated substitute could
then create other risks that could be equal to or greater than
those posed by the original solvent.
B. General Comments Regarding Handling of Intermedia Issues
Over the past several years, there has been a growing
recognition within EPA of the problem of intermedia transfer of
pollution. This term refers to situations in which a regulatory
action designed to limit contamination of one exposure pathway
results in the transfer of that contamination to another pathway
{such as air-stripping, a process for treating water containing
volatile,organic chemicals that results in the release of these
chemicals to ambient air), or those situations in which an action
designed to protect one population results in lowered protection
of another population (e.g., the venting of contaminated air from
the workplace into the ambient environment). Concern for such
transfers is particularly high for the six chlorinated solvents
currently under consideration because of their high volatility,
widespread use, relative persistence in the environment, and
adverse health and environmental effects.
Accompanying this growing awareness on the part of both
EPA staff and management have been attempts to analyze intermedia
effects and to integrate such analysis into regulatory
decisions. For instance, EPA's Integrated Environmental
Management Division has devoted several years to the analysis of
intermedia transfers and the ways in which knowledge of such
effects could be incorporated into local environmental planning
and decision-making.
In certain EPA regulatory decisions, active inter-office
participation has enabled intermedia transfer issues concerning
the solvents to be addressed directly. For example, in the work
underlying the prganic_Chemi r?a1 Tnr^gt-ry Effluent Guideline.
concerted efforts have"been made to examine the volatilization of
chlorinated solvents from wastewater streams and to seek out the
best statutory authority for reducing these emissions. J^fillfij-
examtJJLes include the development of standards for sewage sludge
management and disposal under §405(d) of the Clean Water Act, and
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the estimation of the air impacts of aeration tower treatment of
raw drinking water.
C. Charge to the Committee and Organization of the Report
The charge given to the Integration Report Committee was
three-fold. :First, the IRC was to provide an inventory of the
projects underway or planned by CPSC, EPA, FDA, and OSHA that are
intended to characterize or reduce risks posed by chlorinated
solvents in exposure source categories other than metal cleaning,
-tiry ele-ZMOagT^w^om, and paint stripping. Second, based on
—the-iiiiouiidLj.oJ'1 contained in the inventory and obtained in
interviews of program office personnel, the IRC was to identify
opportunities for further cooperation and gaps in coverage of the
risks posed by these chemicals. Third, the IRC was to assess and
develop recommendations regarding the extent to which further
coordination or integration of these projects was desirable.
These charges are met in the following four chapters of
this report. The exposure source categories covered by this
report, the types of exposure seen in these categories, and how
these exposures are being addressed by current activities are
discussed in Chapter III. Chapter IV discusses the major
elements of the Inventory of analytical and regulatory
activities. This Inventory provides the basis for comprehending
the breadth of activity in this area and assessing the degree to
which there are opportunities for enhanced coordination of
efforts and analytical or regulatory gaps. These opportunities
and gaps are then discussed in Chapter V. Finally, Chapter VI
contains the recommendations of the IRC.
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III. EXPOSURE SOURCE CATEGORIES
The information underlying the workgroup effort that led
to the Feasibility Study was an assessment of the risks posed by
various exposure source categories in which these solvents were
found. There are more than 20 exposure source categories and
numerous subcategories that are not covered by-the Development
Plan. All of the identified exposure source categories are
listed in Table 1, along with the particular solvents found
therein.
The exposure source categories upon which this report
focuses have been grouped under four broad headings: (1) the
manufacture of the solvents themselves and their use as
feedstocks or intermediates to manufacture other chemicals;
(2) their use as solvents; (3) their management as wastes; and
(4) their presence in drinking water.
1. MANUFACTURE / FEEDSTOCK
Carbon Tetrachloride Manufacture
Methyl Chloroform Manufacture
Methylene Chloride Manufacture
Perchloroethylene Manufacture
Trichloroethylene Manufacture
Chlorinated Fluorocarbon (CFC) Manufacture
Miscellaneous Intermediates
2. USE AS SOLVENT
Adhesives Manufacture and Use
Chlorine Manufacture
Ethylene Dichloride Manufacture
Foam Blowing
Food Processing
Pesticido Manufacture
Pesticid- Formulation
Pestici;!'- Use
Pharmac---;r. ical Manufacture
Rubber <• I'lastics Manufacture
MANAGEMENT AS WASTES
Wastewater/Solid Waste Treatment
Publicly Owned Treatment Works (POTW's)
Solvent Recovery
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Storage (Tanks, Piles, Ponds)
Land Disposal
Incineration
Underground Injection
Waste Site Clean-up
4. DRINKING WATER
These exposure source categories result in different types
of exposures. Table 2 shows the types of potentially significant
exposures that would be theoretically expected in these exposure
source categories. Exposure is shown as either direct or
indirect. The former is defined here as exposure resulting
directly from the process or use of the solvents, while the
latter is exposure resulting from the subsequent discharge or
treatment of the process or use wastes. The five environmental
compartments into which exposure potential has been divided are:
ambient air (including tropospheric ozone formation),
stratospheric ozone, ambient water, the occupational environment,
and consumer uses (primarily from the use of products containing
the solvents).
Most of these human and environmental exposures are or
will be controlled through regulatory actions taken by one of the
Agencies or Offices involved in this project. The relationship
between the exposure source categories and these regulatory
actions is shown in Table 3. These regulatory actions are
briefly described in Chapter IV. In addition to regulatory
activities, there are many information gathering and analytical
activities underway.. While this report does not discuss these
activities, their relationship to the exposure source categories
is shown in Table 4..
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TABLE t
SOLVENT USE BY
DCM
CATEGORY
PCE
TCE
MCF
Page 1/2
CFC-113
Primary Chemical Production
Methy lene Chloride (DCM)
Perch loroethy lene (PCE)
Trlch loroethy lene (TCE)
Carbon Tetrachlorlde
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TABLE 1 :
USE BY EXPOSURE SOURCE CATEGORY (con't)
Page 2/2
Paint Strippers Manufacture & Use t
Pa 1 r)tsf_Coa tl ng s AJL Inks Manufacture 4 Use
Pesticide Formulation & Use
Pharmaceutical Manufacturing & Formulation
Reaction Medium
Extraction Solvent
Pill Coating
Polyurethane Foam Blowing Agent
Printing
Ink Thinner
Press & Plate Cleaner
Rubber & Plastics Processing & Formulation
Vinyl Floor Coverings Manufacture
Tank Car Linings
Cellulose Acetate Film Manufacture
Synthetic Rubber Processing
Moid Release Agent
Polyester Fiberglass Manufacture
Shrink Fitting of Elastomerlc Materials
Bonding Plastic Parts
Motile Manufacturing Solvent
•Bnsporratlon of Solvents & Mixtures with Solvents
Waste Management
Industrial Maste«ater & Solid Waste Treatment
Wastewater Treatment In POTW's
Storage of Wastes (drums, piles, or ponds)
Disposal of Wastes
Clean-up of Waste Sites m_m_
Drinking Water
X
X
X
X
*
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X .
X
X
X
X
n
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X •
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
*
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
* » Negligible Use ? « Uncertain Use t -Category Covered by PMC Development Plan
Source : PEI, inc. reports for EPA on ambient air and occupational exposures.
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TABLE 2 : POTENTIAL ROUTES OF EXPOSURE TO CHLORINATED SOLVENTS
rRUuUliilUN / rttUoHA/is
Methylene Chloride
Perch loroethy lane
Trlchloroethy lane
Carbon Tetrachlorlde
Methyl Chloroform
CFC's
Misc. Intermediates
USE AS SOLVE8JhwJves
Chlorine Mfr.
Ethylene DJ chloride
Foam Blowing
Food Processing
Pesticide Manufacture
Pesticide Formulation
Pesticide Use
Pharmaceutical Form.
""MpWfK.i-.t
POTW's
Solvent Recovery
Storage
Land Disposal
Incineration
Underground Inject Jon
Waste Site Clean-up
DRINKING MATER
Ambient Air &
Snog/Ozone
D
D
D
D
0
D &
D &
D &
D
D
D
D
D
D
D
D
Direct
Direct
D & 1
Direct
Direct
^ Direct
Direct
Stratospheric
Ozone Dep.
0 &
0 &
D &
D &
D
D
• o
D
D
D
D
Direct
D & 1
Direct
Direct
0 & 1
Direct
Direct
I Direct
*«&?
D
D
0
D
D
D
D
Indirect
0 & 1
D & 1
D & 1
Oil
Indirect
Direct
D & 1
Direct
Direct
D & 1
D & 1
Direct
Indirect
Direct
Direct
Occupational
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Dl reel-
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Direct
Consumer
Direct!
Direct (small)
Direct
it
Direct
Direct : Emissions or discharges enter directly Into this exposure compartment.
Indirect : Emissions or discharges enter.this exposure conpartment through downstream
processes Tsuch as. storage, disposal, or wastewater treatinmenT) or through
transfer from another meal am.
D 4 I : Bath direct and Indirect emissions or discharges occur.
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TABLE 3 : ON-GOING OR PLANNED REGULATORY ACTIVITIES RaATED TO CHLORINATED SOLVENTS
rrtULHJUI ION / rttUo IUul\
Hethylene Chloride
Perch 1 oroethy 1 ene
Tr I ch 1 oroethy 1 ene
Carbon Tetrachlorlde
Methyl Chloroform
CFC»s
Misc. Intermediates
USE AS SOLVENT^ iyes
Chlorine Mfr.
Ethyl ene Dichlorlde
Foam Blowing
Food Processing
Pesticide Manufacture
Pesticide Formulation
Pesticide Use
Pharmaceutical Mfr.
WASTE MANAGEMENT ^_ _.
Tn-PlanT Treatment
POTVMs
Solvent Recovery
Storage
Land Disposal
Incineration
Underground Injection
Waste Site Clean-up
DRINKING WATER
Clean Air Act
NESHAP, NSPS
NESHAP, NSPS
NESHAP, NSPS
NESHsWs
NSPS.SCPP
NSPS,SCPP
MNESHAP,NSPSM
NESHAP
NESHAP
NESHAP, NSPS
NESHAP
NESHAP
NESHAP
NESHAP
NESHAP
NESHAP
NSPS
MES HAP, NSPS
Clean Water Act
OCI Eff/G
OCi Eff/G
OCI Eff/G
OCI Eff/G
OCI Eff/G
OCI Eff/G
OCJ^Ef f/GM_
XI Eff/G
XI Eff/G
Eff/G
Eff/G
Eff/G
Eff/G's
405
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TABLE 4 : ON-GOING OR PLANNED ANALYTICAL* ACTIVITIES RELATED TO CHLORINATED SOLVENTS
(Inc. ChemicaOpec*)
Methyl ene Chloride
Perch 1 oroethy 1 ene
Tr I ch 1 oroethy 1 ene
Carbon Tetrachlorlde
Methyl Chloroform
CFC»s
Misc. Intermediates
USE AS SOLVENT
Adhesives
Chlorine
Ethyl ene Olchlorlde
Foam Blowing
Food Processing
Pesticide Manufacture
Pesticide Formulation
Pesticide Use
Pharmaceutical Mfr.
WASTE MANAGEMENT
Tn-Plant Treatment
POTW's
Solvent Recovery
Storage
Land Disposal
Incineration
Underground Injection
Waste Site Claan-up
OR INK) MS WATER
MsnflSltta
ORD.OW
ORD.OW
ORD.OW
ORO.OW
OW
ORD
ORD
ORO, OSW
ORD .OSW
OSW
ORO, OSW
ORDjOSW
ORO^OW
feW
ORD
ORD
ORO
ORO
ORO
OW
Hazard, Risk or
Expos. Assmts.
OAR,ORO,OSHA
OAR,ORD
OAR, ORO
OAR, ORO
OAR, ORO
OAR, ORO
OAR
OAR
OAR
OAR
OAR
OAR
OPP
OAR
OAR
OAR, OSW
OAR, OSW
OAR, OSW
OW,OSW
OW
.Control
Technology
OA«,0*
OAR.ORD.OW
OAR.ORO.OW
OAR, ORO, OW
ORD.OW
OW
OAR.OW
OAR,OSHA,OW
OAR,OSHA,OW
OAR,OSHA,OW
OAR,OSHA,OW
OAR,OSHA,OW
OAR,OSHA,OW
OSHA.OW
OAR,OSHA,OW
ORO,OSHA,OW
OAR, ORD, OW
[OAR.SVK.OSHA.OW
OAR,RD,SW,OSHA
OAR, ORD, OSW
ORDrOSW,OW
OW
ORO
ORD.OW
Economic Anal.
I Model Ing
OAR .
OSHA,OTS,OW
OAR.OTS.OW
OAR.OTS.OW
OAR.OTS.OW
OAR,OTS,OW
OAR.OTS.OW
OARjOTS^OW
OAR, OS HA
OAR, OS HA
OAR, OS HA
OAR, OS HA
OAR, OS HA, OW
OAR,OSHA,OW
OSHA.OW
^OAR^HA^W^
OAR,OSHA,OW
OAR.OW
OAR,SW,OSHA,OW
OAR,OSW,OSHA
L osw
OSW.OW
osw.ow
ORD.OW
Note that most of the analytical work designated by the Office of Water Is complete.
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IV. THE INVENTORY OF ACTIVITIES
The Inventory of activities currently underway or planned
(as well as some that have been completed) by CPSC, EPA, and OSHA
can be found in Annex II (FDA has not provided an inventory of
its activities). While this inventory includes data-gathering,
analytical, and regulatory efforts, this report concentrates
almost exclusively on regulatory efforts. This is not intended
to minimize the importance of integrating data-gathering or
analytical efforts. The importance of analytical activities is
evident, but with limited time available, it was necessary to .
focus this report on regulatory activities. This Chapter
discusses the most important regulatory activities underway in
EPA and OSHA (CPSC and FDA did not provide sufficient input to
discuss their activities within this context).
A. Office of Air & Radiation (OAR)
The four major regulatory efforts within OAR dealing with
chlorinated solvents are discussed below. In addition, there is
currently a potential action underway that would add one or more
chlorinated solvents (e.g./ perchloroethylene) to the list of
chemicals that are considered negligibly reactive for the
purposes of ozone formation. This may have the effect of
eliminating emission control reguirements from State
Implementation Plans (SIP's) for these solvents and as a result,
may increase the use in non-attainment Air Quality Control
Regions (AQCR's) of these solvents in preference to chemicals
still considered reactive.
1. Hazardous Organic NESHAPS (HON)
1. This activity is an attempt to expedite the
promulgation of standards under §112 of the Clean Air Act {NESHAP
standards) for eight volatile organic chemicals, four of which
are covered in this report (methyl chloroform and CFC-113 are not
included in the NESHAP action). The HON is directed toward
emissions from chemical process facilities, and thus will cover
production of the solvents themselves and their use as feedstocks
such as in the~ production of CFC's. The HON will not cover
categories other than chemical processing (e.g., metal cleaning
and dry cleaning).
2. Air Oxidation and Distillation NSPS
This New Source Performance Standard (NSPS) rule is
designed to limit the emission of reactive hydrocarbons from air
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oxidation and distillation processes from new synthetic organic
chemical industry facilities nationwide. The proposed rule
package is currently being reviewed by OMB. These proposed rules
are technology-based and as such do not directly consider health
risks or the -potential effect on stratospheric ozone depletion.
In addition, these rules are aimed only at those organic
compounds that contribute to significant tropospheric ozone
formation (e»g'. , carbon tetrachloride, perchloroethylene, and
trichloroethylene).
3. Treatment, Storage & Disposal Facility Air Emissions
This^rule is being written oy OAR under the authority of
§3004(n) of RCRA. This provision requires the setting of air
emission standards that are protective of health and the
environment for hazardous waste treatment, storage, and disposal
facilities (TSDF). Covered facilities would include land
treatment, landfills,.waste piles, treatment storage and handling
operations, wastewater treatment and surface impoundments, and
pretreatment devices. This rule is being developed in
conjunction with OSW's development of the Land Ban and the other
TSDF rules.
4. Stratospheric Ozone Protection Program
This program was developed to respond to the requirement
of §154(b) of CAA and an NRDC settlement that require the
Administrator to propose a regulatory decision regarding the need
to control ozone depleters by March 1987 and to promulgate a
decision by November 1987. These actions will address the risks
posed by the potential depletion of stratospheric ozone and the
resulting effect of increased global ultraviolet (CJV-B)
radiation. There, are related international negotiations, being
conducted under the auspices of the United Nations Environment
Programme (UNEP), concerning the development of global strategies
for protecting the ozone layer.
B. Office of Pesticide and Toxic Substances (OPTS)
Inerts Strategy
Having identified pesticide "inert" ingredients (i.e.,
those substances other than the active pesticide itself) of
demonstrated toxicity, OPP developed a strategy that would lead
to the limitation or prohibition of use of some of these
chemicals in pesticide formulations. Of the 1200 identified
inert ingredients, 55 are considered toxic, including five of the
six chlorinated solvents covered by this report (the exception is
CFC-113). Methylene chloride and methyl chloroform appear to be
the most widely used chlorinated solvents in pesticide
products. Additional data may be requested from companies that
use these chemicals as inerts so that the extent of exposure and
resulting risks can be better understood and appropriate action
taken.
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C» Office of Solid Waste and Emergency Response (OSWER)
Land Ban
Rules are being developed in response to requirements of
the Hazardous and Solid Waste Amendments (to RCRA) of 1984
.(HSWA). Among other things, the land disposal of hazardous
waste, as defined under RCRA, is prohibited unless EPA makes a
positive finding that such land disposal is protective of human
health and the environment. Specific treatment or a successful
petition are the only exceptions to the ban, absent the positive
finding. Hazardous wastes are to be reviewed on a scheduled
basis; the first group schedules to be banned in November 1986
includes the solvents covered in this report. These chemicals,
as reactants or uses as other than solvents, will be reviewed in
successive phases of the land disposal restrictions program*
Solvents were included in the first phase of this program because
of their adverse health effects and the fact that they can
permeate and destroy the liners used to contain wastes in
landfills.
D. Office of Water (OW)
1. Organic Chemical Industry Effluent Guideline
This is the last of the NRDC Consent Decree effluent
guidelines to be promulgated, and there is a court order
requiring promulgation by December 1986. A major intermedia
issue that has arisen in connection with this rulemaking is the
"air-stripping" (i.e., volatilization to ambient air) of volatile
organic solvents from wastewaters. This volatilization occurs in
wastewater streams, in wastewater treatment, from POTW's, from
receiving waters, and can also be directly produced through air-
stripping technology designed to meet performance standards in
the effluent guidelines. This issue is being dealt with by a
special inter-office workgroup.
2. Other Effluent Guidelines
OW is considering re-opening the effluent guidelines
dealing with the pesticides manufacturing industry and the
pharmaceutical industry to better control the volatile organics
discharged by these industries.
3. Domestic Sewage Study Project Follow—up (DSS)
The DSS was required by Congress to address the problems
created by the discharge of hazardous wastes into sewers. The
DSS made recommendations regarding various mechanisms for
reducing the discharge of these wastes to POTW's. The DSS was
submitted to Congress in February of this year. New and revised
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V. GAPS AND OPPORTUNITIES
There are numerous examples where the regulatory
activities just described offer opportunities for coordination or
integration. ; Further, there are several examples where .exposures
to chlorinated solvents appear not to be covered by on-going
activities. The most important of these opportunities and gaps
are described below.
A. Opportunities for Coordination or Integration
As one might expect after looking at Table 3,
opportunities for coordination or integration are numerous
because several regulatory activities often affect the same
industry. The clearest example is in the synthetic organic
chemical process industry where process air emissions will be
regulated by the Hazardous Organic NESHAP, an NSPS, and may be
regulated under the Stratospheric Ozone Protection Program; water
discharges will be covered by the OCI Effluent Guideline and
probably by the regulatory follow-up to the. Domestic Sewage
Study; hazardous waste disposal will be affected by hazardous
waste listings, the TSDF air emissions rule, and the Land Ban;
and occupational exposures will be regulated through OSHA
requirements. There is a clear need to insure that these
activities are thoroughly coordinated or integrated to address
intermedia issues that have arisen.
In several instances, these.intermedia issues are in the
process of being addressed. An excellent example is the
workgroup that has been formed to address volatilization of these
solvents from wastewater streams (air-stripping). However, there
are other instances where intermedia issues are acknowledged but
not addressed because of some constraint (e.g., a serious time
constraint in the case of the Land Ban) and yet other instances
where intermedia issues are simply not addressed.
With respect to specific source categories that might
profit from coordination or integration, there are several
instances where simultaneous activity is planned and coordination
or integration should be implemented:
(a) Pesticide manufacture and pesticide formulation will
probably be covered by a specific NESHAP and the pesticide
manufacturing effluent guidelines may be reopened in the
near future to improve controls on volatile organics. In
addition, the OPP inerts strategy may lead to significant
reductions in the use of some chlorinated solvents as
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_ 1 "7 _
inerts, which obviate the need for at least certain types
of air and water controls.
(b) Pharmaceutical manufacturing and food processing will
probably bs covered by a specific NESHAP and the
pharmaceutical manufacture effluent guidelines may be
reopened in the near future. The interest of the FDA is
unknown, but certainly should be explored.
(c) PQTW's will be affected by the regulatory follow-up to
the DSS, by the §405(d) sewage sludge rule, by a POTW-
specific NESHAP, by the TSDF air emissions rule, and by
restriction on the land disposal of wastes (the Land Ban).
Finally, Maximum Contaminant Levels (MCL's) for drinking
water will be promulgated later this year and in the future for
chlorinated solvents. The Land Ban and other hazardous waste
requirements are related to these activities in that many of
their restrictions are directed toward preventing contamination
of groundwater. In addition, many effluent guidelines restrict
the discharge of these solvents into receiving waters that are
drinking water sources.
B. Gaps in Coverage
One of the major reasons for creating Tables 2 and 3 was
to help the IRC identify gaps in regulatory coverage of exposures
to chlorinated solvents. While this process may not have
illuminated all of them, several gaps in regulatory coverage of
potential significance became apparent during the course of
reviewing these activities. These gaps fell into two groups:
those where action to close the gap was underway or planned and
those where no action was contemplated.
The most obvious gap is caused by the lack of adequate
OSHA standards for the five solvents other than methylene
chloride. This creates not only a gap in worker protection, but
it will also lead to data gaps that might be reflected in the
risk analyses and control options analyses done for those
activities that are going forward. If OSHA agrees to become a
full participant in implementing the Development Plan, it will
agree to consider developing more stringent workplace standards
for these five solvents and will thereby begin to close this gap.
The second major gap is between the controls on indirect
discharges of wastewaters (i.e., discharges to POTW's) and the
controls on the disposal of hazardous wastes. In many instances
it is legal to discharge wastes that are considered hazardous
wastes into domestic sewage systems as a result of the RCRA
domestic sewage exemption.' In the case of chlorinated solvents,
this exemption essentially transfers the locus of air emissions
from the facility to the sewer system. The Domestic Sewage Study
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regulatory effort has been started to address this problem, but
how this effort will deal with these discharges has hot yet been
decided.
This gap exists because OSWER believed that OW was going
to promulgate regulations to close the gap and so proceeded to
promulgate their own regulations without addressing this
problem. However, the water regulations have not yet been
proposed. In the meantime, this will continue to be a serious
gap in exposure coverage, especially given the anticipation that
restrictions :on land disposal may increase the volume of wastes
dumped into sewers.
Another gap arises from OAR's list of solvents not
regulated as tropospheric ozone precursors. Methyl chloroform,
carbon tetrachloride, and CFC-113 are on this list, and
substitution of these potential stratospheric ozone depleters for
ozone precursors has occurred. As mentioned above, OAR has
proposed to add perchloroethylene to this list, and is
considering adding other chlorinated solvents as well. While
there is still controversy about the extent to which these
represent a health hazard, for the moment the use of these
chemicals remains largely uncontrolled (the only exception is
non-essential aerosol uses). The SOPP may address these
concerns, but until that time this remains a gap.
Another intermedia consideration rarely addressed in EPA
rulemakings is the effect of control options on occupational
exposures. Controls to limit ambient emissions can be at cross-
purposes from occupational controls because the former aims to
reduce emissions leaving the facility while the other aims to
reduce concentrations inside the facility.
The final gap identified is statutory in nature. The
OSH Act does not cover State and municipal workers in POTW's in
about 25 States and territories without State OSHA plans. This
appears to be a serious gap in occupational coverage with respect
to chlorinated solvents. The several activities that could
affect the discharge of these solvents to POTW's might reduce the
need for this coverage, but at the moment there seems to be a
significant need for action to protect workers given the likely
increase in frequency of dumping these solvents into sewers and
the subsequent occupational hazards that result (e.g., two recent
deaths of sewer or POTW workers from chlorinated solvents
exposure).
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VI. CONCLUSIONS AND RECOMMENDATIONS
In response to its charge, the IRC has developed
recommendations regarding the extent to which further
coordination or integration is appropriate for current and
planned projects involving chlorinated solvents. During the
course of developing these recommendations/ the IRC also
concluded that there were several improvements that could be made
in the existing regulatory development process and that it was
necessary to define integration before it could recommend
integration. The process recommendations are described in the
first part of this chapter followed by the specific
recommendations.
A. Recommendations on the Regulatory Development Process
While it was not specifically charged to do so, the IRC
realized that it was necessary to examine the organizational
context within which chlorinated solvents activities were being
developed so that recommendations on how to deal with them in the
future could be rationally developed. This examination of
chlorinated solvents activities and the developmental processes
in which they were incubated led the IRC to conclude that with
respect to chlorinated solvents:
Better coordination or integration is necessary to
insure that intermedia issues are satisfactorily
addressed in CPSC/EPA/FDA/OSHA actions dealing with
chlorinated solvents.
— Improvements can be made to the way in which intermedia
effects are handled in data-gathering, analytical, and
regulatory actions dealing with chlorinated solvents.
— These improvements should be directed toward making the
existing syvem more consistently responsive, to
intermedia issues and systematically insuring upper
management knowledge of major intermedia issues
involving chlorinated solvents.
— CPSC/EPA/FDA/OSHA can no longer rely on ad hoc
coordination eEforts for chlorinated solvents
activities but must build certain automatic responses
into the review system to insure that these intermedia
issues are adeauately addressed.
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1. The extent to which proposed controls would lead to
substitution of different chlorinated solvents, thereby
resulting in no net risk reduction or an increase in
risk.
2. The effect any control options may have on occupational
exposures.
3. The effect any control options may have on
stratospheric ozone or global warming (taking into
account any substitution effects).
4. The effect any control options may have on transferring
chlorinated solvents to other media and the relative
risk of such transfers.
5. The potential for producing more efficient control by
regulating the problem under other statutory authority.
6. The extent to which other Offices contributed or helped
gather data.
One problem EPA has had in the past has been the
duplication of data-gathering and analytical efforts. Point 6
above is intended to help remedy that problem. For example, OAR
has attempted to collect OW data on POTW air emissions before
collecting new data.
These suggestions should increase the workgroups'
cognizance of intermedia concerns and their responsibility for
insuring that they are addressed. However, even with these
improvements, there are aspects of the conventional regulatory
development process that are less than ideal for solving complex
problems involving chlorinated solvents as pollutants and
wastes. The conventional process and the tasks of the workgroup
usually aim at solving part of the problem using a previously
determined statutory authority, leaving other parts of the same
problem to be solved separately. One of the advantages of an
"integrated" approach is that it considers the whole problem and
the variety of authorities that can be brought to bear, in
combination or separately, to resolve the entire problem before
commencing the development of particular regulations.
2. Integrating Pre-Regulatory Decisions
The term "integration" has had different meanings to
different persons involved in the chlorinated solvents
activity. Therefore, before describing the process itself, the
term will be delineated.
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An "integrated regulatory investigation" is an effort in
which several regulatory program offices and agencies:
(1) develop and use common assessments of a complex problem; and
(2) agree upon the most effective and efficient set of regulatory
solutions. This entails more than simply informing one another
of activities and exchanging information. Integration means that
studies and analyses needed to make decisions are jointly
designed and ^carried out and that the preferred regulatory
solutions are jointly agreed upon from the full range of
available statutory authorities. The assessments should be
collectively planned and developed from the outset to yield a
comprehensive view of, and solution to, the problem. Note that
it is the planning and conduct of assessments and selection of
the preferred regulatory approach that is integrated, not the
implementation of that approach. Once the regulatory approach
has been agreed upon, the responsible offices and agencies carry
out rulemaking independently, but seek to continue to avoid
duplication and inconsistency to the extent permitted by law and
agency policy. Ongoing and new assessments and analyses would
continue to be integrated.
Integrated investigations and decisions imply that
differences in objectives, priorities, legal requirements, or
methods of collecting and analyzing data among the various
offices and agencies will be reconciled to achieve the common
objective. It may, for example, call upon some offices or
agencies to accept another's method of estimating exposure
concentrations, or to defer regulation under their statutes if it
is collectively determined that the better regulatory solution
lies elsewhere. Integrated decisions cannot, of course, override
statutory-specific mandates, constraints, standards of evidence,
or criteria, nor can integration interfere with legislated or
judicial deadlines.
The process description that follows constitutes an
integrated process. It is theoretical in that it has never been
used before, but logically it should produce a better result than
the normal process. One reason this is not done routinely is
because the overall statutory framework is fragmented among
several different offices and agencies.
The integration process begins when CPSC, EPA, FDA, or
OSHA jointly and explicitly decide that a particular group of
related pollution problems that pose significant intermedia
issues, such as chlorinated solvents, should be dealt with
through an integrated strategy. It should be noted that this
decision has not yet been made for chlorinated solvents.
The second step of the process would be the constitution
of an inter-agency panel to oversee the integration process.
Such a panel has been created to oversee this process (i.e., the
PMC). While the PMC has gained a great deal of insight by
working on this problem for the last three months, it might be
useful to augment its membership so that each of the offices and
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agencies listed below would have a representative. These
representatives should be branch chief level people (or their
equivalent at other agencies) who are either working directly on
chlorinated solvents activities or who are very well acquainted
with their office's chlorinated solvents activities.
Consumer Product Safety Commission
Environmental Protection Agency
Air Quality, Planning & Standards
:Statospheric Ozone Protection Program
General Counsel
Pesticide Programs
Toxic Substances
Policy, Planning & Evaluation
Research & Development
Solid Waste
Drinking Water
Groundwater Protection
Water Regulations & Standards
Food & Drug Administration
Occupational Safety & Health Administration
The third step would be for the panel to develop an
overall plan .that identifies current activities dealing with
chlorinated solvents and describes an agreed-upon approach for
dealing with those exposure source categories not being dealt
with by current activities. This plan would have to be ratified
by all participating offices and agencies. The underpinning of
this plan would be a comprehensive assessment of the total
problem presented by chlorinated solvents in all media in all
exposure source categories. This assessment would, by default,
identify those areas where sufficient and insufficient
information existed for decision-making. In addition, the
assessment would reveal the relative risks presented by different
exposure sources, thereby permitting the panel to identify
potentially significant intermedia problem areas and gaps in
regulatory coverage.
After these steps have been completed, the panel would
have three major functions: (1) it would periodically review
current activities with a view toward insuring that all
participating offices and agencies were aware of the actions
being taken and the possible implications for their own
chlorinated solvents activities; (2) it would be responsible for
implementing the plan for addressing the remaining chlorinated
solvents exposure source categories; and (3) it would act as an
advisory committee to the EPA Steering Committee on SAR's and
development plans that might have some effect on chlorinated
solvents activities using as the basis for its analysis the plan
that had already been approved. If there were instances where
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the panel believed that significant intermedia chlorinated
solvents problems were not being adequately addressed, it would
have the ability to raise these concerns through the management
chain.
The IRC believes that, if well implemented, an integrated
approach has the potential for creating a significantly improved
process for dealing with chlorinated solvents problems. The
advantages and disadvantages of integration are carefully
described in the Development Plan, so they will not be repeated
here. However, as with all new processes, unanticipated problems
will arise, higher than expected resource requirements may be
encountered until the participating offices and persons are
familiar with the process, and the degree to which it will
fulfill its potential is unknown.
The IRC recommends that the integrated process described
above be implemented for those chlorinated solvents activities
listed in Section B.2. below. This would permit all involved to
become acquainted with the process and permit the process to
become polished before attempting it on a larger scale.
B. Activity Recommendations
1. Activities Subject to the Improved Workgroup Process
There are several activities that are past the point in
the regulatory process where integration could be usefully
considered. However, the IRC recommends that these activities be
subject to the improvements described in Section A.I. above,
specifically that the existing workgroups be assigned the
responsiblity for addressing the six issues listed therein.
These activities are listed below, along with specific comments
and recommendations.
Hazardous Organic NESHAP (HON)
This is an excellent example of the type of activity that
would have been a candidate for an integrated approach, but a
workgroup has already been assigned and it has been singled out
for special treatment hy EPA's Steering Committee. In addition
to the issues listed in Section A.I., the IRC recommends that the
development plan for the HON make explicit provision for
addressing the followi :
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n
Land Ban
The IRC recommends that the subsequent phases of the Land
Ban (the "thirds") explicitly address the following issues in .
addition to those in Section A.I.: (1) the effect of any control
strategy on wastewater concentrations of chlorinated solvents and
the quantity of wastewater discharges containing chlorinated
solvents; and (2) the effect of any control strategy on ambient
air emissions.
Pesticide Manufacture
The IRC recommends that, if any actvities are initiated on
pesticide manufacture, the initiating office make systematic
efforts to address intermedia issues. In particular, the
development plans should make explicit provision for addressing
the following issues in addition to those in Section A.I.:
(1) the effect of any ambient air control strategy on wastewater
concentrations of chlorinated solvents; (2) the effect of any
wastewater control strategy on ambient air concentrations of
chlorinated solvents; (3) the effect of any potential action by
OPP to restrict or prohibit the use of chlorinated solvents as
inerts on the cost-effectiveness or need for any control
strategy; and (4) the effect of any control strategy on the
amount of hazardous waste generated.
2. Candidates for Integration
The following exposure source categories should be
considered as candidates for integration by the PMC, as described
in Section A.2. above. These candidates meet one or more of the
following criteria: (1) human or environmental risk is
significant; (2) the potential for substitution is great;
(3) there are substantial intermedia concerns; or (4) two or more
offices would be regulating the same industry.
Foam Blowing
Pesticide Formulation
Pharmaceutical Manufacture
Discharges to POTW's
This recommendation should not be construed as criticism
of the past and current efforts of those actively working on
these projects to incorporate the views of other program
offices. However, in each of these instances,, there will be some
level of analysis of done by more than one program office, and
the IRC believes that this is precisely the situation that calls
for integration.
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3.Other Recommendations
Adhesives Manufacture & Use
The IRC recommends that OSHA take the lead in working with
CPSC, OAR, OTS and OW to identify exposures, risks, and
regulatory options for this exposure source category.
Air-Stripping
The responsibilities of the inter-office workgroup that
was established to identify potential statutory solutions for the
air-stripping problem related to the OCI effluent guideline
should be expanded to include other areas where air-stripping is
an issue (e.g., POTW's, drinking water treatment facilities, and
hazardous waste treatment facilities).
Food Processing
The IRC recommends that OSHA take the lead in working with
FDA, OAQPS, OTS, OWRS, and SOPP to identify exposures, risks, and
regulatory options for this exposure source category.
Pesticide Use
The IRC recommends that OPP take the lead in working with
CPSC, OAQPS, and SOPP to identify exposures, risks, and
regulatory options for this exposure source category. .
Occupational Exposure Controls
OSHA is exploring the possibility of revising its
workplace standards for methylene chloride. If it becomes a
signatory to the Development Plan, it will examine the need to
revise the other five solvent standards as well. However, it is
not clear that OSHA will take action on any exposure source
category beyond the four covered by the Development Plan.
The IRC recommends.: (1) that OSHA re-examine its workplace
standards for all six chlorinated solvents in all exposure source
categories; (2) that OSHA take an active part in EPA workgroups
to insure that occupational concerns are addressed; (3) that OSHA
invite participation by CPSC, EPA, and FDA in the development of
its workplace standards; and (4) that OSHA consider intermedia
issues in its rulemaking to the extent possible.
Other Exposure Source Categories
The IRC recommends that the PMC investigate whether
further efforts are warranted to characterize risk in the
exposure source categories not covered by this report.
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Stratospheric Ozone Protection Program
The IRC recommends that the SOPP be integrated under its
own separate inter-agency panel. The IRC further recommends that
this panel consider the effects of placing potential ozone
depleters on the list of non-reactive organic compounds. This
panel and the PMC should, communicate regularly on matters
relating to the intersection of stratospheric ozone depletion and
chlorinated solvents.
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