* **
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S 00?* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C, 20460
JUN 2 7 1986
MEMORANDUM
OFFICE OF
PCSTICtDES AND TOXIC SUBSTANCES
SUBJECT: Plan for Integrating the Regulation of
Chlorinated Solvents
FROM: John A. Moore, Assistant Administrator
for Pesticides and Toxic Substances (TS-788}"
TO:
Addressees
The attached document, prepared by the interagency
^> chlorinated solvents workgroup, sets forth the Plan for an
integrated regulatory investigation of chlorinated solvents in
four major exposure source categories. A second report, to be
submitted within two weeks, will explore how other activities on
chlorinated solvents might profit from further integration.
This Plan proposes that our respective program offices and
agencies carry out mutually agreed-upon regulatory assessments
and that, in late 1986 and 1987, we jointly select the preferred
regulatory approach from among the full range of available
statutory authorities.
Six subject-matter committees, each chaired by a
representative from the appropriate office or agency, have been
established to oversee these assessments. The chairs of these
committees, together with representatives from each concerned
office and agency, comprise the Project Management Committee
(successor to the Interagency Chlorinated Solvents Workgroup),
which will coordinate the overall effort. The integration of
assessments and analyses will occur primarily through interaction
of involved offices and agencies on these committees. The last
page of the attached Plan lists the participants in this
integrated investigation.
To facilitate adoption of the Plan, I have scheduled a
briefing for the recipients of this memo on July 11, 1986, from
9:00 to 10:00 a.m., in Room #1 of the North Conference Center at
EPA Headquarters. At that briefing, I propose that we have a
general discussion of the Plan and address the following specific
issues:
CD
>
HEADQUARTERS LIBRARY
ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.G. 20460
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1. establishing an interagency senior management body
to facilitate resolution of issues raised during the
course of the regulatory investigation! and to select
the preferred regulatory approach from among the options
provided;
2. funding currently unplanned or unbudgeted assessments
identified in the Plan as essential components of the
integrated regulatory investigation?
3. reviewing membership on the Project Management Committee
to assure appropriate representation during the
operational phase of the regulatory investigation.
Given the very short deadlines established in the Plan, I
hope we will be able to reach tentative conclusions on each of
the above three issues at our July 11, 1986 meeting. To this
end, you may want an individual pre-briefing on the plan as a
whole, or on specific aspects of particular concern. If so,
please call Ed Brooks (382-3749), Chairman of the Project
Management Committee, who will be pleased to make the necessary
arrangements. Following our discussion of the Plan on
July 11, 1986, I will submit it to the four agencies for final
approval and action.
I very much appreciate the participation of your organization
in the development of this Plan. Successful implementation will
depend in large part upon your continued participation.
Addressees:
Francis S. Blake, General Counsel, EPA
Leonard DiFiore, Executive Director,
Consumer Product Safety Commission
Donald Ehreth, Acting Assistant Administrator
for Research and Development, EPA
Lawrence J. Jensen, Assistant Administrator f
for Water, EPA
Sanford A. Miller, Director, Center for
Food Safety and Applied Nutrition, FDA
John A. Pendergrass, Assistant Secretary
for Occupational Safety and Health, DOL
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J. Winston Porter, Assistant Administrator
for Solid Waste and Emergency Response, EPA
J. Craig Potter, Assistant Administrator
for Air and Radiation, EPA
Milton Ru,ssell, Assistant Administrator
for Policy, Planning & Evaluation, EPA
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PLAN FOR INTEGRATING REGULATORY
INVESTIGATIONS OF
CHLORINATED SOLVENTS
IN FOUR EXPOSURE CATEGORIES
Chlorinated Solvents
Project Management Committee
June 20, 1986
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TABLE OF CONTENTS
Introduction •
I. Discussion of Integrated Regulatory Investigations
Page
,. .1
, . .2
II
A. Definition •• 2
B. Conditions Calling for Integration 3
C. Advantages 3
D. Disadvantages 4
E. Conclusion 5
Plan for Integrated Regulatory Investigation 6
A. Background 6
B. The Plan '. .' 9
1. General Description of Investigation 10
2.
3.
4.
Appendix A -
Appendix B -
Task Summaries • 15
Water Pollution and Waste Disposal 26
Resource Allocations 28
Profile of Four Exposure Categories 32
Subcategories ......35
Appendix C - Preliminary Exposure Data Specifications ....37
Appendix D - Participants in Solvents Effort 44
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INTRODUCTION
This document is a follow-up to the Report on the
Feasrbility'of an Integrated Regulatory Investigation of
ChlorinaTed" Solvents, dated February 26, 1986. That Report
evolved from investigations of methylene chloride undertaken by
the Environmental Protection Agency (EPA), the Consumer Product
Safety Commission (CPSC), the Food and Drug Administration (FDA)
and the Occupational Safety and Health Administration (OSHA), as
announced in an Advance Notice of Proposed Rulemaking dated
October 17, 1985 (50 FR 42637). As those investigations
proceeded, the potential substitutability of methylene chloride
with other toxic chlorinated solvents, together with their multi-
media pollution potential, suggested that these solvents should
be addressed as a group and in an integrated manner under all
relevant statutory authorities. The Feasibility Report therefore
recommended (1) integration of several ongoing investigations of
the risks posed by six major chlorinated solvents in four major
exposure categories, and (2) assessment of the need to integrate
other activities designed to address chlorinated-solvent
problems. On March 19, 1986, EPA's Steering Committee requested
that the Report's two recommendations be developed in greater
detail.
This paper presents the plan for a multi-agency
investigation that is to culminate in late 1986 and 1987 in
selection of options for regulating chlorinated solvents in four
major exposure categories. Part I defines what is meant by
"integrated investigations", notes the conditions under which
they appear desirable, and discusses some of the advantages and
disadvantages. Part II presents the plan. It specifies the
assessments that will be performed by each EPA office and each
agency, indicates the anticipated costs and schedules, and
describes the integrated analytical process that will lead to
selection of the most efficient and effective regulatory
approach.
A subsequent paper, to be submitted at the end of June 1986,
will make recommendations regarding the need to integrate
interagency chlorinated solvents activities not encompassed by
the four exposure categories.
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PART I
DISCUSSION OF INTEGRATED REGULATORY INVESTIGATIONS
A. Definition
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.
Coordination, in contrast to integration, involves sharing
plans and exchanging information among concerned offices and
agencies, but without subjecting the plans or decisions of any
office or agency to collective review in order to arrive at a
single integrated approach. Coordination can occur at the point
at which assessments are undertaken, as regulatory decisions are
made, or as rulemaking commences. Integration requires
assessments to be "collectively planned and developed from the
outset, insofar as possible, 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 are
integrated, not the implementation of that approach. Once the
regulatory approach has been agreed upon, the responsible offices
and agencies carry out rulemaking independently. Ongoing and new
assessments and analyses, however, 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 insofar as possible 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
court-ordered schedules.
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B. Conditions Calling for Integration
Integrated assessments and decisions are desirable when:
a. the. chemicals of concern appear in more than one medium
or are subject to regulation under more than one
statutory authority;
b. controls imposed under one authority to reduce
exposures in any given medium may increase exposures in
other media; or
c, differing analyses and views about the nature and
magnitude of risks posed by the chemicals might lead to
inconsistent or conflicting regulation by various
offices and agencies.
C. Advantages
There are three advantages to integrated regulatory
assessments and decisions.
The most important one is the comprehensive perspective they
provide. This broad perspective tends to shift the focus away
from questions about what to do with each statutory authority, to
the more useful question of how to most effectively use those
authorities to address the overall problem. A comprehensive (as
opposed to an authority-specific) view of the problem can reveal
the relative risks presented by different exposure sources and in
different media, and can highlight intermedia transfers that
might occur under specific regulatory options. This can reveal
omissions, underreactions and overreactions in statutory-specific
responses to various aspects of the problem, and may yield an
entirely different regulatory response (e.g., a ban under TSCA §6
for certain uses, rather than independent and possibly less
effective restrictions on emissions, effluents, workplace
conditions and consumer exposures — or, alternatively, a
different combination of media-specific restrictions).
The second advantage to integration is efficiency of
regulation. An integrated approach can yield a more coherent
regulatory framework that (1) achieves the desired level of
protection at a lower societal cost, and (2) provides the
regulated community with a clearer understanding of what to
expect.
The third advantage is efficiency of rulemaking. By
integrating assessments and analyses we can eliminate duplicative
work and conserve data collection and assessment resources.
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D. Disadvantages
The major disadvantages to integrated investigations arise
from the fact that the relevant Federal authorities (CAA, CPSA,
CWA, FDCA, FHSA, FIFRA, OSHAct, RCRA, SDWA and TSCA) are
administered independently of one another -- with most
assessments, rulemaking decisions and resource allocations made
entirely within the framework of each specific statutory
authority and administering office or agency. A certain amount
of disharmony is inevitable in any attempt to integrate
assessments and unify regulatory decisions among autonomous
entities. Two potential difficulties are:
1. the problem of integrating independent efforts that are
already well-defined and underway; and
2. the question of how to allocate resources and
responsibilities for work required by the integrated
effort but not contemplated by any of the participating
offices or agencies.
The first problem results from the fact that at any point at
which it is decided to integrate* most offices and agencies will
already be well into their respective regulatory
investigations. Completed and on-going work, together.with
established schedules and anticipated products, will generally
have to be adopted "as is". The most reasonable solution is a
five-phased evolutionary approach to integration that:
establishes a process for securing resolution of
>, and approval of proposals, from the consortium
rticipating offices and agencies;
1.
2.
3.
4.
5.
issues
issues, ana approval or proposals, trc
of participating offices and agencies
adopts, as is, work already completed or well underway;
jointly supplements that work to provide any
assessments necessary to round out the integrated
investigation;
collectively, analyzes all assessments to provide the
consortium with the comprehensive information needed to
select the preferred overall regulatory approach; and
collectively agrees, prior to initiation, upon any new
work proposed to be done by any participating office or
agency.
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The second potential difficulty is how to fund and carry out
work that is considered necessary for the integrated effort, but
that is not planned or budgeted by any of the participating
entities. The fact that a particular activity is identified as
necessary for the integrated effort does not mean that the burden
of doing it should be borne by the office or agency that would
normally do that work. An integrated approach requires a
mechanism for equitably distributing the costs and responsibility
of carrying out work that has been collectively specified. While
a recommendation regarding that mechanism is beyond the scope of
this paper, it will clearly require agreements among and
decisions by the consortium of participating entities.
E. Conclusion
The following multi-agency plan to cooperate in assessing
and ultimately controlling chlorinated solvents in four major
exposure categories, while clearly less than "an integrated
regulatory investigation" as defined above, should prove
beneficial. It deals with an important segment of the total
chlorinated solvents problem and essentially brings together —
for collective development, analysis and decision-making —
assessment activities that were already underway in the several
offices and agenci-es. This approach will enable us to
immediately and effectively integrate operational activities.
The plan is a reasonable strategy for preliminarily
examining risks posed by four major categories of chlorinated
solvent exposures in order to select the optimum set of
regulatory responses from among the total authorities and options
available. The agreement to coordinate previously independent
assessments, to conduct future assessments in concert, and to
collectively identify regulatory options, may materially improve
upon the regulatory decisions that would have otherwise been
made. The plan should be viewed as a first step in an
evolutionary process to establish the merits of integration
without-unduly delaying ongoing regulatory efforts.
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PART II
PLAN FOR INTEGRATED REGULATORY INVESTIGATION OF
CHLORINATED SOLVENTS IN FOUR EXPOSURE CATEGORIES
A. Background
. Chlorinated hydrocarbon compounds play an important role in
the U.S. economy. They are used primarily in a wide variety of
solvent applications, but also as chemical intermediates, as
refrigerants, in aerosol delivery systems, and in a number of
other uses. This paper refers to these compounds collectively as
chlorinated solvents.
The six major chlorinated solvents on the basis of
production volume are:
Solvent
Carbon Tetrachloride (Tetrachloro-
methane)
Methyl Chloroform (1,1,1-trichloro-
ethane)
Methylene Chloride (Dichloromethane,
DCM, or MC)
Perchloroethylene (Tetrachloro-
ethylene or PCE)
Trichloroethylene (1,1,2-trichloro-
ethene or TCE)
CFC-113 (l,l,2-trichloro-l,2,2-
trifluoroethane)
1984 U.S. production
(metric tons)
324,000
307,000
275,000
260,000
(1)
(1) "
(1)
95,000
68,000 (3)
(1) USITC 1985. U. S. International Trade Commission, Synthetic
Organic Chemicals, U. S. Production and Sales, 1984,
Washington, DC, USITC Publication 1745.
(2) SRI 1985. SRI International, Integrated Solvents
Analysis: Trichloroethylene, Contract No. 68-02-3976, SRI
International, Menlo Park, CA, May 1985.
(3) SRI 1985. SRI International, Integrated Solvents
Analysis: CFC-113, Contract No. 68-02-3976, SRI
International, Menlo Park, CA, June 1985.
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The four exposure categories that are the subject of this
proposed regulatory investigation are:
0 industrial and commercial metal cleaning;
0 industrial, commercial/ and coin-operated dry cleaning;
o formulation, and commercial and consumer use of
aerosols;
0 formulation, and industrial, commercial and consumer
use of paint strippers?
These categories were selected from an initial list of
fifteenl/ on the basis of:
(1) magnitude of risk, so that the greatest degree of risk
reduction could be achieved;
(2) availability of support data (either in hand or
anticipated), so that immediate actions could commence
without waiting for new studies; and
(3) amenability to integration, including consideration of
solvent interchangeability, the number of exposure
pathways, and cross-media transfer.
About 85 percent of the total estimated excess lifetime
(70-year) cancer cases from classifiable exposures (approximately
2U,000 out of a total of about 23,000) arise in the four selected
categories. These four categories also account for the
preponderant uses of the five primary chlorinated solvents
(59 percent of methylene chloride, 68 percent of
perchloroethylene, 86 percent of trichloroethylene, 81 percent of
methyl chloroform, and 69 percent of CFO113). Profiles of the
four exposure categories are provided in Appendix A.
Four of the six chlorinated solvents — carbon
tetrachloride, methylene chloride, perchloroethylene, and
trichloroethylene — have been classified as "probable human
carcinogens" by EPA under its "Proposed Guidelines for
_!/ The other eleven categories originally considered were:
electronics, chemical intermediates, foam blowing,
Pharmaceuticals, food processing, POTWs, solvent recovery,
adhesives, methylene chloride production, perchloroethylene
production, and trichloroethylene production.
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Carcinogenic Risk Assessment." _2/ Depending upon the level of
exposure, these solvents also pose a range of noncarcinogenic
acute and chronic risks to humans, including cardiovascular
damage, central nervous system dysfunction, liver and kidney
damage, and reproductive abnormalities. In addition, CFO113,
methyl chloroform and carbon tetrachloride are believed to
contribute to stratospheric ozone depletion, which in turn may
result in excess skin cancers and adverse climatic changes. A
bioassay is' planned by the National Toxicology Program (NTP) for
methyl chloroform, now considered a suspect animal carcinogen.
There is some potential for interchangeability among these
solvents. 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 risks
equal to or greater than those posed by the original solvent.
The groblem of substitutability is most effectively addressed^ by
considering these solvents as a_ group, rather than individually,
and across all major uses.
Use and handling of these chlorinated solvents result in
their release to and transfer among all environmental media —
air, water, and land — and in exposures to workers, consumers,
and the general public. Notwithstanding considerable past
Federal investigatory and regulatory attention, significant gaps
remain in our understanding of the problem. Occupational and
ambient air exposures appear to be insufficiently controlled, and
water and land pollution issues may require additional efforts.
Relatively little is known about the extent or levels of consumer
exposure to products containing these solvents, or about the
health or environmental consequences of chlorinated solvents
present as inert ingredients in pesticides. The problem of
inter-media transfer is most €^f f ec tively addressed by integrating
the assessments and regulatory decisions of aJLV invo 1 ved offices^
and agencies.
_2/ 49 FR 46294 (Nov. 23, 1984). Each of these four solvents
has been classified as a Group B2 carcinogen under the EPA
Proposed Guidelines. This classification means that there
are sufficient experimental animal data to show that the
substance is carcinogenic in animals, but insufficient
epidemiological data regarding the substance's
carcinogenicity in humans.
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B. The Plan
This Plan provides for (1) joint assessment by the
participating EPA offices and other Federal agencies of six
chlorinated solvents in each of four major exposure categories
and (2) collective identification of regulatory approaches to
each of these categories in late 1986 and 1987.
Key elements include: (!) integrated development of
assessments via pooling of expertise and resourcesr (2) joint
review of those assessments, and (3) collective identification of
appropriate regulatory options from among all available statutory
authorities. The integration is to be achieved through the
coordinated efforts of six subject-matter committees that have
been established for the purpose, each chaired by a
representative of the appropriate office or agency, and with
representation by all interested EPA offices and other agencies.
The six subject-matter committees are:
1. the Hazard and Risk Assessment Committee, chaired by
the EPA Office of Research and Development;
2. the Occupational Exposure and Control Committee,
chaired by OSHA;
3. . the Ambient Air Exposure and Control Committee, chaired
by the EPA Office of Air and Radiation (OAR);
4. the Consumer Exposure and Control Committee, chaired by
CPSC;
5. the Regulatory Options Committee, chaired by the EPA
Office of General Counsel (OGC); and
6. the Economics Committee, chaired by the EPA Office of
Toxic Substances (OTS).
Overall management of the regulatory investigation will be
carried out by a Project Management Committee (PMC), comprised of
the chairs of each of the six subject-matter committees, and
representatives from EPA offices, OSHA, CPSC and FDA.
The assessments and other documents specified in this Plan
to support the regulatory investigation will be developed by
designated program offices and agencies within the framework and
guidance provided by the relevant subject-matter committees.
These committees, operating in concert, will provide integrated
planning of the assessments, ensure consistency in assumptions
and methodology in their implementation, avoid duplication of
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effort among the program offices and agencies, and bring a global
perspective to the identification and analysis of regulatory
options.
At key decision points, subject-matter committee chairs will
present draft documents to the PMC for policy-level review. PMC
members are sufficiently senior and informed to reflect the views
of their of/fices and agencies with respect to these issues, and
will keep their parent organizations informed. By this
mechanism, program offices and agencies will stay abreast of the
progress and direction of the project as it advances, so that
concurrence with final products, when presented, will be
expedited.
Resolution of issues and approval of proposals submitted by
the PMC to the consortium of participating offices and agencies
must be prompt in order to avoid having the integrated effort
inordinately delay ongoing individual regulatory programs.
Effective implementation-of this proposal requires (1) expedited
internal review by each agency of issues and proposals emanating
from this effort, and (2) a mechanism for timely joint decisions
by CPSC, EPA, FDA and OSHA.
^•* General Description of the Regulatory Investigation
Figure 1 provides an overview of the integrated options
selection process for the metal cleaning and dry cleaning
exposure categories. It shows (1) committee tasks, (2) the
sequence of activities to be undertaken, (3) the timing of
products to be delivered, and (4) the flow of information from
one group to another.
Figure 2 presents the same information for aerosols and
paint stripping categories. Regulatory options papers for these
two categories are scheduled six months later than for dry
cleaning and degreasing, because additional time is required to
obtain support data. Brief descriptions of each task identified
in Figures 1 and 2 are provided under "Task Summaries", below,
and in Appendix C.
In all cases, the general flow of information is from the
three Exposure/Control Committees to the Hazard/Risk Assessment
Committee where (1) hazard and exposure information will be
combined to generate risk estimates, and (2) projected exposures
resulting from control options will be analyzed to generate
estimates of achievable reductions in risk. These data will then
be transmitted to the Economics Committee for incorporation into
the economic analysis. The Regulatory Options Committee will
then use the model to generate "what if" scenarios under the
available statutory authorities.
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The six subject-matter committees are represented by the
oval symbols on the left side of the diagrams. Each committee
oversees development of certain analyses, assessments, or
reports. The key documents in the regulatory investigation are
identified by the symbol i"*^^ . _3/ The chronological
progression of activities represented by the diagrams is from
left to right. Using Figure 1 to illustrate the process, these
activities will culminate in regulatory options papers by the end
of Februaryx1987 _4/. All reports will be distributed to the
PMC. Those denoted with triangular symbols will be the subject
of formal PMC review.
The Hazard and Risk Assessment Committee (HRAC) will use the
available Preliminary Hazard Assesssment, in conjunction with the
reports developed by the three Exposure/Control Committees and
the Economics Committee, to develop Preliminary Risk Reports by
September 30, 1986 and, in the case of consumer exposures, by
October 30, 1986.
The Exposure Data Specification prepared by the HRAC will
provide the Ambient Air, Consumer, and Occupational
Exposure/Control Committees with guidance on the substance and
format of their respective reports.
The Hazard Assessment Status Report, to be presented to the
PMC by August 15, -1986, will predict the extent to which the
preliminary health assessments might have to be revised to
account for more recent research in carcinogenic hazard
quantification. The Hazard Assessment Status Report will also
discuss the need to further consider ozone depletion and global
warming.
In the Hazard Identification of Substitutes, the HRAC will
describe, to the extent possible, health hazards associated with
likely substitute solvents, based on the Use/Substitutes Report
to be provided by the Economics Committee. The Hazard
Identification of Substitutes will be presented to the PMC for
their recommendations regarding which substitutes warrant special
_3_/ All documents to be developed for the four exposure
categories are listed in Tables 1 through 5, and described
in Task Summaries and Appendix C.
Assuming that the currently available cancer-hazard
assessments will have to be modified in light of studies now
nearing completion. If not, the options selection paper
could be completed two months earlier.
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concern. Risk analyses on the chosen solvents will be performed
to the extent possible. Experts representing the various offices
on the HRAC will help determine what, if any, additional analyses
are warranted.
The three Exposure/Control Committees will provide existing
and new exposure assessments and Control Options Analyses that
will-enable'the HRAC to evaluate the risk reduction potential of
the various control options. These control options analyses,
particularly in the case of consumer exposures (October 30,
1986}, will not be ready for the Preliminary Risk Assessment
(September 30, 1986), but the results will be incorporated into
the Economic Analysis (described on page 24).
To address cross-media concerns and to ensure that
recommended control options will not inadvertently transfer risks
from one exposure route to another (e.g., from the workplace to
ambient air or vice versa), the chairs of the three
Exposure/Control Committees, with designated representatives from
the Office of Water and the Office of Solid Waste and Emergency
Response, will review each of the three control options analyses
and will incorporate their findings in the Inter-Media Control
Options Analysis. This document will be presented to the PMC for
review by late September 1986. The PMC's findings concerning
inter-media implications will be part of the determinations
regarding which regulatory options to recommend. Because of the
limited time available before options selection, the inter-media
analyses concerning water pollution and waste disposal will be
somewhat sketchy at first. They will be refined, insofar as
necessary, during the post-options selection phase of the
rulemaking process.
The Regulatory Options Committee (ROC) will prepare a
Statute s An aly s i s, by late June 1986, of the applicability,
specific data needs, strengths and weaknesses of the
availability, authorities for reducing risks posed by chlorinated
solvents in each exposure category. The ROC, in conjunction with
the chairs of the other subject-matter committees, will then
prepare a Preliminary Regulatory Options Analysis. This report,
scheduled for late October 1986, will relate the analyses of
statutory authorities with the most likely control options that
have been identified.
The Economics Committee (EC) will then assess the economic
implications of the most likely options. Through several
iterations between the EC, ROC and HRAC, the EC will assist in
the selection of options by showing the relationships between
risk reduction and cost for various alternatives.
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The ROC, in concert with the. subject-matter committee
chairs, will prepare the final Regulatory Options Analysis by
February 1, 1987 (or two months earlier if the current hazard
assessments are used). This document will enable the PMC to
draft the final Regulatory Options Selection Paper.
There .will be one options selection paper for each of the
four categories. The options presented will be in terms of
regulatory approaches and which statutes to employ, rather than
specific exposure limits or control techniques. For example, one
option for metal cleaning could be the use of TSCA to prohibit
the use of MC, PCE, TCE, or CC14 for this purpose. An
alternative could use a combination of OSHAct, CCA, and RCRA to
control direct and indirect (inter-media) exposures by
instituting specified control technologies, best available
technology, etc.
The Options Paper will be presented to the consortium of
participating offices and agencies at joint decision meetings
convened to select the regulatory approach. Subsequent to the
decision meetings, each agency with responsibilities for the
statutory authorities selected will implement the decisions and
commence rulemaking in the manner required by its laws and
policies.
2. Task Summaries
The tasks indentified in Tables 1 through 5 comprise the
assessments and other documents needed to enable management to
select regulatory options. The various tasks are identified
separately under the four exposure source categories, with the
exception of the hazard assessments, which are chemical-specific
and do not differ by exposure source category.
Table 1 identifies the hazard assessments that will be
prepared for each of the solvents. Tables 2 through 5 identify
the exposure, risk, control options, and economic and regulatory
options assessments that will be generated for each of the four
selected exposure source categories. These tables also indicate
scheduled completion dates for each task, the estimated costs,
the responsible EPA office or other agency, and the planning and
budget status of these activities in their programs. A
description of each task follows.
-15-
-------
Hazard Assessments
i. Exposure Data Specifications. Chairs of the HRAC and
the three Exposure/Control Committees will define in
detail the substance and format of the exposure data
that will be provided for the integrated risk
assessment. This has already been partially
accomplished (see Appendix C), and further efforts in
this regard are continuing. Final specifications are
due by June 30, 1986.
ii. Methyl Chloroform and CFC-113 Updates. This document,
prepared by OHEA under the auspices of the HRAC, will
review the most recent literature and integrate
"qualitatively" any new considerations. It will also
address the ozone depletion issue. The report is due
by July 31, 1986.
iii. Hazard AssessmentStatus Report. This report, prepared
by OHEA and reviewed by the HRAC, will predict how the
current preliminary cancer hazard assessment for
methylene chloride, perchloroethylene and
trichloroethylene might have to be modified for the
final hazard assessment in light of ongoing metabolic
and pharmacokinetic studies [see Task (vi) below]. The
report will be presented by the HRAC to the PMC by
August 15, 1986.
iv. Hazard Ide n t i f i c a t i on o f S ubstitutes. Due to the large
number of substitute solvents and the short timeframe,
this document will only consist of a quick summary of
existing assessments and a review of the literature to
identify health risks. The assessment will be prepared
by OHEA and will address those substitutes that were
recommended for consideration by the PMC, based on
their review of the use/substitutes report [see Task
(vii) described under Metal Cleaning below]. The
assessment will be presented by the HRAC to the PMC by
July 31, 1986.
v. Non-carcinogenic Endpoints Report. This report,
prepared by OHEA under the guidance of the HRAC, will
draw on work by the Risk Forum and examine whether
"risk numbers" can and should be calculated for
non-carcinogenic effects of methylene chloride,
perchloroethylene, and trichloroethylene. This
document will be incorporated in the Preliminary Risk
Reports, to be presented by the HRAC to the PMC by
September 30, 1986.
-16-
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-------
vi- Mechanism of Action and Pharmacokinetics Assessments.
These assessments, performed by OHEA, will evaluate the
results of the ongoing toxicological efforts and modify
the carcinogenic hazard assessments for methylene
chloride, perchloroethylene and trichloroethylene, if
necessary. Both of these assessments, which are
components of the Final Hazard Assessment, are
scheduled for completion by the beginning of November,
so that OHEA and the HRAC can use them for the Final
Risk Assessment which is due by December 1, 1986.
vii. Review of New Kodak Study. This effort will evaluate
the latest epidemiological cancer data on methylene
chloride. The review, to be performed by OHEA, is
contingent upon the receipt of data from Kodak,
expected by late July 1986.
b. Metal Cleaning
11.
Ambient Air Exposure Assessment. This assessment,
performed by OAQPS under the auspices of the Ambient
Air Exposure/Control Committee, breaks out the ambient
air exposures by the three types of cleaning equipment,
specifically cold-cleaning, vapor degreasing, and
conveyor'ized degreasing (release rates and control
technology vary by equipment type). The assessment
comprises documentation on (1) exposure model inputs,
(2) short-term emission inputs, (3) maximum
concentration modeling, (4) exposure analysis of each
chemical for baseline emissions and controlled-emission
scenarios, (5) Industrial Source Complex (ISC) modeling
results, and (6} short-term dispersion calculations.
This assessment has been submitted to the HRAC for
their use in developing the Preliminary Risk
Assessment.
Ambient Air Control Options Analysis. This analysis,
also prepared by OAQ.PS, will present control options,
cost estimates, and supporting documentation for
control of metal cleaning operations. Costs will be
generated for each of the three degreaser types
(cold-cleaners, open-top vapor degreasers, and
conveyorized degreasers). This analysis, to be
completed by the end of August, will be used in the
economic analysis of regulatory options, and by the
chairs of the Exposure/Control Committees for
performing their Inter-Media Control Options Analysis,
which will be presented to the PMC by September 30,
1986.
-22-
-------
iii. Occupational Exposure Assessment. This report,
performed by OTS under the auspices of the Occupational
Exposure/Control Committee/ provides the following
information, based mostly on available data:
(a) definition of the exposure source category by 3- or
4- digit SIC code; (b) estimate of the number of
workers exposed to each solvent (by SIC code where
possible); (c) routes of exposure; (d) levels of
inhalation exposure to each solvent (as time-weighted
averages and, where possible, as short-term exposure);
(e) distribution of workers over exposure ranges if
possible; (f) frequency and duration of exposure;
(g) basis of estimates (monitoring, modeling,
extrapolation); and (h) bibliography. The report has
been completed in draft form and will be submitted
shortly to the HRAC for their use in developing the
Preliminary Risk Assessment.
iv. Occupational Control Options Assessment. This
assessment, prepared by OSHA and OTS, will present the
following information, based mostly on available
data: (a) description of various types of controls
currently used (engineering controls, work practices,
personal protective equipment); (b) exposure levels for
each solvent associated with various arrays of control
measures; (c) methods for achieving exposure reduction;
(d) characterization and distribution of control arrays
within each industry; and (e) costs of achieving most
feasible reductions within each industry. The
assessment is scheduled for completion by the end of
August and will be used in the economic analysis, and
by the chairs of the Exposure/Control Committees for
performing their Inter-media Contol Options Analysis,
which will be presented to the PMC by September 30,
1986.
v. Intermedia Control Options Analysis. Each of the
control options assessments will be collectively
reviewed by the chairs of the Exposure/Control
.Committees and the designated representatives from OW
and OSWER, who will prepare an Inter-media Control
Options Analysis. The purpose of this document, to be
completed by late September 1986 for ambient air and
occupational exposures is to ensure that any
recommended control options will not inadvertently
transfer risks from one exposure route to another.
(A similar inter-media analysis for consumer exposures
is expected to follow two months later.) This analysis
will be presented to the PMC for approval. The results
of this review will be used to develop of the
recommended control options.
-23-
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vi. Preliminary and Final Risk Assessments. Both documents
will be prepared by OHEA, with the active participation
of the HRAC. The preliminary assessment, to be
completed by September 30, 1986 will address
carcinogenic risks posed by exposures to methylene
chloride, trichloroethylene, and perchloroethylene,
based on existing preliminary hazard assessments. The
final risk assessment document, to be completed by
December 1, 1986, will incorporate the results of
ongoing hazard assessment activities: pharmacokinetic
and metabolic studies, examination of non-carcinogenic
end points, epidemiological studies, and a qualitative
assessment of substitute solvents.
vii. Use and Substitutes Report. This report, prepared by
OTS, will address to the extent possible the following
for each exposure source category: (1) Use (analysis
of costs associated with use, breakdown of use
characteristics by SIC code, estimated output per unit
solvent use); (2) model plan or process definition; and
(3) costs of substitution (identification of
substitutes by use classification and estimates of
substitution costs). The report will be completed by
mid-June, and subsequently presented to the PMC. The
PMC will recommend which solvents should be addressed
in the Substitute Hazard Identification, scheduled by
the HRAC for mid-July 1986.
viii. Economic Analysis. The economic analysis will be a
fairly standard evaluation of the economic implications
of proposed regulatory actions. It will evaluate
changes in costs of the affected producing or use
groups, and benefits in terms of exposure or risk
reduction. Because there is close substitution among
several sovlents in some of the markets and a large
amount of data to handle in the calculations, a linear
programming model is being developed to assist with the
analysis.
Costs are expected to flow from three types of
responses: (1) installation of control technology?
(2) implementation of workplace practices and
standards; and (3) substitution for the chlorinated
solvent affected by a regulatory option. The direct
engineering costs of control or workplace practice
requirements are being developed by the Ambient Air and
Occupational Exposure/ Control Committees. The costs
of substitution are being developed by the Economics
Committee.
-24-
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IX.
Benefits flow from reductions in exposure and risk
as a result of the regulatory options. The technical
basis for the benefit measures is being developed by
the three exposure/control committees and the Hazard
and Risk Assessment Committee. The analysis will
account for changes in exposure and risk based on the
technical inputs of these committees.
/'
Regulatory options can range from exposure or risk
limitations to specification of technical controls.
For the set of regulatory options identified by the
Regulatory Options Committee, in conjunction with the
subject-matter committee chairs, the results of the
economic analysis will include an evaluation of the
incremental cost-effectiveness of the options.
Some concern has been expressed over the
assumptions of inelastic end-product demand and
horizontal supply functions (constant price) initially
built into the linear programming model. These
assumptions have been made knowingly in the expectation
that they would realistically reflect the reaction in
the marketplace to regulation of one or more of the
chlorinated solvents. The Economics Committee plans to
review these assumptions before completion of the
analysis, and adjust them if necessary.
The results of the economic analysis for the metal
cleaning and dry cleaning exposure source categories
will be funished to the Regulatory Options Committee by
mid-January 1987, for use in the Regulatory Options
Analysis.
Analysis of Statutes. Members of the Regulatory
Options Committee, with representatives from each of
the other committees, will meet as needed to discuss
regulatory options issues and to educate each other on
the strengths and weaknesses of the various regulatory
schemes which appear to be pertinent to the particular
chlorinated solvents exposure source category under
consideration. The insights gained will be imparted
early on to the deliberations of the other committees
in order to promote efficiency in their regulatory
investigation. In addition, a brief written analysis
of statutory authorities will be prepared by the
Committee relative to regulatory control options
available for the four exposure source categories.
This analysis is scheduled for late June 1986.
-25-
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XI
Regulatory Options Analysis. The Regulatory Options
Committee, in conjunction with the subject-matter
committee chairs, will evaluate the regulatory options
associated with the various "model scenarios," which
are based on exposure and risk as well as economic
analyses. Regulatory options will be evaluated in
terms of (a) legislative authority, (b) effectiveness
of risk reduction, (c) efficiency, (d) evidentiary
requirements, (e) procedural requirements, and
(f) practicability (e.g., enforceability}. A
regulatory options analysis, containing a range of
options and recommendations, will be submitted to the
Project Management Committee by early February 1987.
This document will form the basis for the Options
Selection Paper.
Options Selection Paper. This document, to be prepared
by the PMC, will transmit the Committee's regulatory
recommendations to the management of EPA and the other
participating agencies. The Options Selection Paper is
scheduled for late February 1987; however, it could be
accelerated by about two months if the Preliminary Risk
Analysis does not have to be modified because of
potential inadequacy of the existing Preliminary Hazard
Assessment.
c. Dry Cleaning, Aerosols, Paint Stripping
The tasks to be accomplished for the exposure source
categories of dry cleaning, aerosols, and paint stripping are
generally the same as for metal cleaning (see Tables 2 through
5). Therefore, the general task descriptions included under the
category of metal cleaning will not be repeated for the remainder
of the exposure source categories. Appendix C specifies in
detail the exposure and control options data that will be
developed for each of the four exposure categories.
3. Water Pollution and Waste Disposal
At the outset, this effort focused on chlorinated solvents
as a health problem in air. As the project developed, however,
it became clear that to be complete the Plan should address the
risks these chemicals may pose in surface-, ground-, and
drinking-water, and the regulations in place or planned to
control waste disposal practices.
-26-
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With respect to surface water, solvents are clearly a matter
of concern. Five (the exception being CFC-113) are priority
pollutants and have water quality criteria because of their human
and environmental toxicity. Their volatility also significantly
adds to ambient air levels because they volatilize from effluents
both before and after discharge. Wastewater treatment systems
[both- in-pl.ant and publicly-owned treatment works (POTWs)]
further increase the amount volatilized. While these discharges
are ultimately manifested as air pollution, effective control may
require restrictions upon water treatement and discharges.
Moreover, while volatilization reduces the quantity
remaining in the aquatic environment, these solvents may still
pose water-borne hazards. Because they adsorb onto suspended
solids in either the waste stream or the receiving waters, the
high volatility measured in the laboratory may not occur under
real-world conditions. Thus, where discharged with or into
high-solids waters, these chemicals may present a hazard to
humans or to the ecosystem via drinking water or through uptake
into the food chain.
Most effluent guidelines do not limit discharges of these
chemicals. The exceptions do so via a limitation on Total Toxic
Organics. The Off.ice of Water intends to reconsider several
effluent guidelines in the future, and discharges of these
solvents may be further restricted.
Recommended Maximum Contaminant Levels (RMCLs) have been
promulgated for trichloroethylene, perchloroethylene, methyl .
chloroform, and carbon tetrachloride to control risks posed by
chlorinated solvents in drinking water obtained from both surface
and ground waters. MCLs for these compounds have been proposed,
and promulgation is expected later this year. The Office of
Drinking Water (ODW) is currently developing RMCLs for methylene
chloride and freons (which would include CFC-113).
These solvents, when improperly disposed, may also present
air emission and groundwater risks. They can deteriorate
landfill liners, with serious consequences for the integrity of
the landfill. They move readily through soil to contaminate
groundwater. Major public health problems have resulted from the
use of well water contaminated with these solvents. They also
present air emission risks from treatment and disposal
facilities.
Many wastes containing these solvents as well as the
solvents themselves as waste products, are "listed", meaning that
their disposal is strictly regulated. Further regulation under
the proposed Land Ban will further restrict disposal of listed
solvents by this November, with follow-on activities planned to
-27-
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cover other waste categories containing these substances. The
ambient air emissions will be covered by the Treatment, Storage,
and Disposal Facility (TSDF) rules being developed by the Office
of- Air and Radiation (OAR) under RCRA authority.
In view of the foregoing, the PMC recommends that this Plan
be expanded.to consider the existing and planned regulations
affecting these solvents in the water and waste media. While we
do not expect to have a complete analysis of the intermedia
effects of water and waste regulations in time for the
late 1986/early 1987 options selection, any preliminary
information obtained by that time will be useful.
4.
Resource Allocations
Although this plan has identified and briefly described the
various tasks that need to be accomplished in the regulatory
investigation of the four exposure categories, an office-by-
office presentation of the estimated resource requirements is in
order. Table 6 indicates the estimated FTEs and contract dollars
for each office, broken down into three categories:
(!) budgeted, (2) planned/not budgeted, and (3) not planned. The
"not planned" category offers a useful insight into what costs
are directly attributable to the proposed integrated regulatory
investigation; the other costs would be incurred even in the
absence of the proposed Plan. As the table indicates, the total
costs in the "not planned" category are 0.7 FTEs and $85K — out
15.9 FTEs and $1,305K.
-28-
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Taole 6
ESTIMATED AND INCREMENTAL COSTS
FOR THE INTEGRATED CHLORINATED SOLVENTS EFFORT
X*
Agencies & Offices
TOTAL
CPSC - Total
Dry Cleaning (Perc)
Aerosols
DCM
Perc, CH3CC13
Paint Stripping
RgPS T- Total
Metal Cleaning
DCM, Tri, Perc
CH3CC13, CFC-113
Dry Cleaning
Perc
CFC-113
Aerosols
Paint Stripping
OGC [Overhead Only]
TASKS
Budgeted
.FTEs
12.6
3.0 .
0.5
0.5
0.5
1.5
1.6
0.4
0.4
0.4
0.4
__
Contract
SK
1,001
50
50
316
90
61
75*
90*
—
Planned/Not Budgeted
FTEs
2.6
0.3
0.3
— —
__
Contract
$K
219
200
200
«*<•»
__
Not Planned
FTEs
0.7
.•
0.7
0.3
0.4
__
Contract
$K
85
85
25
60
—
Relatively low priority and subject to budget cuts,
-29-
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Table 6 Continued
>
t
f
OHEA — Total
Hazard Assessments
DCM
Tri
Perc
cci4
CH-^CCl,
CFC-113
Substitutes
Risk Assessment
Metal Cleaning
DCM, Tri, Perc
CH3CC13
1 Dry Cleaning
Perc
CFC-113
Aerosols
DCM, Perc
CH3CC13
Paint Stripping
DCM
TASKS
tfudgotod
FTEs
1.7
0.2
0.2
0.3
0.3
0.3
0.1
0.2
0.1
Contract
$K
18
14
1
1
1
1
Plannod/ttot Budgeted
FTEs
0.7
0.1
0.1
0.2
0.1
O.'l
0.1
Contract
$K
19
5
5
5
1
1
1
1
Not Plannod
FTEs
Contract
$K
-30-
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Table 6 Continued
^
/
OSHA — Total
DCM (all industry
categories )
Metal Cleaning
Dry Cleaning
Aerosols
Paint Stripping
OTS — Total
Hazard Assessments
Metal Cleaning (all
six, except CC14)
Dry Cleaning (Perc,
| CFC-113)
Aerosols (DCM,
Perc, CH3CC13
Paint Stripping
DCM
Budgeted
FTEs
1.5
1.5
4.8
0.6
1.0
0.8
1.2
1.2
Contract
$K
365
365
252
14
60
24
61
93
TASKS
Planned/Not budgeted
FTEs
*
1.6
0.4
0.4
0.4
0.4
—
Contract
?K
—
—
Not planned
FTEs
—
—
Contract
$K
—
—
Note: For ease of presentation, the 1.6 FTEs were allocated equally among the four
exposure source categories; however, OSHA's assessments are not industry-specific.
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Appendix A
PROFILE OF FOUR EXPOSURE SOURCE CATEGORIES
The following is a brief characterization of each of the
four exposure source categories selected for the proposed
regulatory /investigation.
1. Metal Cleaning
Metal cleaning operations with chlorinated solvents are used
.in a wide range of industrial applications including production
of metal furniture, electric equipment, transportation equipment,
fabricated products, and in other miscellaneous industrial
applications. Metal cleaning is also thought to be common in
commercial applications such as automotive and machinery service
and repair shops.
Five of the six major chlorinated solvents are used in metal
cleaning (all but carbon tetrachloride). The total volume of
chlorinated solvent consumption in metal cleaning (including all
electronics uses) is estimated to range from approximately
325,000 metric tons to as much as 430,000 metric tons per year
(based on 1983). Methyl chloroform is the dominant chlorinated
solvent used in metal cleaning, with approximately 54 percent of
the market, followed by trichloroethylene (19 percent),
perchloroethylene (12 percent), CFC-113 (9 percent), and
methylene chloride (7 percent).
Two major types of metal cleaning processes are used: vapor
degreasing, which comprises vapor-phase cleaning in open-top
degreasing equipment and conveyorized degreasing equipment; and
cold cleaning, or solvent cleaning at temperatures below the
boiling point of the solvent by immersion, wiping, and in some
cases, by spray equipment. It has been estimated that in the
U.S. there are nearly 50,000 units of vapor degreasing equipment
and over 1 million units of cold-cleaning equipment (primarily
small tanks).
Exposure concerns for both vapor degreasing and cold
cleaning include occupational (inhalation and dermal) and ambient
(inhalation).
2. Dry Cleaning
The dry cleaning market can be divided into three sectors:
industrial laundering and dry cleaning, commercial dry cleaning,
and coin-operated dry cleaning.
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The industrial sector is defined as cleaners of garments,
uniforms, and other items that are typically rented to an
institutional or industrial user. Approximately 200 plants in
the industrial sector engage in dry cleaning; 60 percent of these
plants use perchloroethylene, and the remainder use petroleum
solvents. The 120 industrial dry cleaners using
perch-loroethylene use between 3,300 and 12,900 metric tons per
year (based on 1983).
The commercial sector comprises 31,500 retail dry cleaning
plants. Of these, approximately 75 percent use
perchloroethylene, 23 percent use petroleum solvents, and 2
percent use CFC-113. The commercial sector uses between 83,000
and 88,200 metric tons per year of perchloroethylene and
approximately 1,000 metric tons per year of CFC-113.
The coin-operated dry cleaning sector comprises between
8,000 and 11,000 plants with equipment for consumer-operated dry
cleaning. Almost all of the coin-operated equipment uses
perchloroethylene (97.5%); the remaining fraction uses CFC-113.
The total volume of solvent used in the coin-operated sector
ranges from 14,360 to 21,060 metric tons per year of
perchloroethylene and approximately 100 metric tons per year of
CFC-113.
The major exposure concerns for the dry cleaning market are
from ambient releases (all three sectors), occupational
(commercial and industrial) and consumer (coin-operated).
3. Aerosols
The aerosol "use" category includes five major aerosol
product categories as well as the industrial fillers of the
aerosol products. There were over 200 domestic companies with
aerosol filling lines in 1984. Some aerosol product fillers are
strictly contract fillers while others are also involved in
aerosol formulation development.
The major aerosol product categories that use chlorinated
solvents are paints and coatings, automotive and industrial
products, pesticides, personal products, and household
products. The number of products filled in 1984 totaled
approximately 2.4 billion units. Of this, personal products
accounted for the largest share (33 percent), followed by
household products (25 percent), automotive/industrial products
(14 percent), and paints/coatings (13 percent). Estimates of the
total volume of chlorinated solvents used in aerosols vary from
approximately 50,000 metric tons to approximately 70,500 metric
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tons per year. Methylene chloride is estimated to account for
approximately 61 percent of the chlorinated solvent consumption
in aerosols, methyl chloroform 32 percent, and perchlorethylene
7 percent.
The major exposure concerns from aerosol uses are consumer
(inhalation),, as well as occupational and ambient exposure
(inhalation) from aerosol filling operations. Concern about
occupational exposure as a result of commercial uses of aerosol
products and the contribution of aerosol product use to ambient
levels may develop as additional information becomes available.
4. Paint Stripping
Paint stripping is conducted to restore and maintain
commercial, industrial, and consumer equipment, products, and
structures. There are four major applications of paint
strippers. They are architectural (commercial and consumer
restoration of permanent structures), factory products and
equipment (industrial and commercial maintenance/restoration of
spray booths, etc.), government and military goods
(restoration/maintenance of defense weapons, ships, etc.), and
consumer goods (restoration of furniture, etc.). Of the six
chlorinated solvents, only methylene chloride is known to be used
in paint stripper -formulations.
The largest market, by volume of methylene chloride
consumed, is factory products and equipment, accounting for
approximately 70 percent of the volume, followed by
government/military uses (15 percent), and architectural
(2 percent).
The major exposure concerns are occupational and consumer
(inhalation and dermal). Concern about the ambient contribution
of paint stipper uses may develop as additional information
becomes available.
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APPENDIX B
SUBCATEGORIES OF FOUR EXPOSURE SOURCE CATEGORIES
I. METAL CLEANING
A. Industrial
1. Vapor Degreasing
. —- open top vapor degreasing
• — conveyorized vapor degreasing
2. Cold Cleaning
— immersion/spray cleaning
— wipe cleaning
3. Electronics photo-resist stripping
B. Commercial
1. Vapor Degreasing
— open top vapor degreasing
— conveyorized vapor degreasing
2. Cold Cleaning
— immersion tank/spray cleaning
— wipe, or maintenance cleaning
II. AEROSOLS
A. Industrial Fillers/Formulators
1. (all end-product categories)
B. Commerical Uses
1. Paint and Coatings
2. Automotive/Industrial Products
3. Pesticides
4. Household Cleaning Products
5. Personal Products
6. Food Products
C. Consumer Products
1. Paints and Coatings
2. Automotive/Industrial Products
3. Pesticides
4. Household Cleaning Products
5. Personal Products
6. Food Products
III. PAINT STRIPPING
A. Industrial Formulators (all end-products)
B. Industrial Use (including military)
1. OEM Product Preparation/Refinishing/Maintenance
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C. Coramerical
1. Architectural Structures
2. After-Market Refinishing/Maintenance
D. Consumer Uses
IV. DRY CLEANING
A. Commercial
B. Industrial
C. Coin-Operated
Date: April 24, 1986
Source: Regulatory Impact Branch, OTS/EPA
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Appendix C
PRELIMINARY EXPOSURE DATA SPECIFICATIONS
MEMORANDUM
SUBJECT: / Minutes of May 7 Meeting with Representatives of
Economics, Exposure and Health Risk Committees on
Chlorinated Solvents
FROM: Jane Hopkins, Project Manager
Risk Analysis Branch
TO: Edward M. Brooks, Acting Deputy Division Director
Chemical Control Division
THRU: Jeanette A. Wiltse, Chief
Risk Analysis Branch
As a follow-up to the Economics Committee briefing of May 9,
representatives of the Exposure, Economics and Health/Risk
Committees met to deal with issues concerning the development and
integration of ambient air, occupational and consumer solvent
exposure assessments. Time limitations permitted discussion of
only one major topic: the level of analytical detail of solvents
exposure and controls analyses that can be provided to the
Economics and Risk Committees. The meeting was a first step
toward coordinating information among the technical committees,
but many issues remain to be resolved. In particular, we must
determine whether the level of detail of work provided by the
exposure committees will be sufficient to meet the requirements
of the various regulatory offices/agencies for developing
regulations. The following minutes record current expectations
regarding the kind of data that each exposure committee can
incorporate into their respective exposure assessments. The
attached list of priority exposure source categories was the
basis for discussion.
Occupational Exposures and Controls;
based on retrieved monitoring data.)
(Exposure analysis will be
Metal Cleaning (All solvents except Carbon Tetrachloride)
1. The Occupational Exposure Committee will, in general, break
out data on exposures and controls by operation type.
Baseline exposure data, however, will probably be presented
as a general range for the metal cleaning category with the
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exception of electronics subcategories; specific baseline
data can be developed for those uses. Otherwise, a
distinction cannot be made between industrial versus
commercial or vapor degreasing versus cold cleaning for
baseline exposures.
2. The Committee plans to provide data on the numbers of people
exposed from vapor degreasing, cold cleaning, and electronics
subcategories. Vapor degreasing may be further disaggregated
to account for workers in open top vapor degreasing versus
conveyorized vapor degreasing. Cold cleaning probably cannot
be broken down further and no distinction can be made between
the number of workers in industrial versus commercial
operations.
3. Data on controls will probably be provided at the same level
as data on the number of exposed workers, i.e., the Committee
will provide information on generalized types of equipment
controls (e.g., respirators and ventilation) for vapor
degreasing and its subcategories, for cold cleaning (no
subcategories) and electronics subcategories. No distinction
can be made between industrial and commercial exposures.
4. The Committee will investigate the possibility of breaking
out exposure -data by SIC code, but at present there is
speculation that baseline exposures will be similar across
SIC codes and will vary more across equipment type..
Dry Cleaning (Perchloroethylene, CFC-113)
1. The Committee plans to provide data on baseline exposures,
the number of workers exposed and, possibly, control
technology for coin-operated dry cleaning as a separate
subcategory, but no distinction will be possible between
commercial and industrial dry cleaning.
Aerosols (Methylene Chloride, Perchloroethylene,
Trichloroethylene, Methyl Chloroform)
1. The Committee can separate data on baseline exposures, the
number of people exposed and controls into discrete
categories for industrial formulators, spray-paint
operations, mold-release use and a general category under
aerosols labeled as "other."
-38-
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Paint Stripping (Methylene Chloride)
1. Data baseline exposures, number of workers exposed and
control options can be broken out for industrial use versus
industrial formulators, with industrial use subcategorized
"into aircraft stripping and furniture refinishing. The
Committee cannot provide specific data for "commerical use."
Implications for Risk Assessment and Options Selection;
Baseline risk assessments and predicted levels of risk
reduction from implementation of controls can be generated for
exposure source categories at the level at which we have data on
the numbers of people exposed and control measures. For the
metal cleaning category, however, such assessments may be based
on baseline exposure information that is not specific for a
particular equipment type. Thus, risk reduction estimates may
include a fair amount of uncertainty.
For example: the effect of controls on metal cleaning
occupational exposures can be broken out by equipment type, but
the analysis will be based on the assumption that baseline
exposures are the same across the metal cleaning category (i.e.,
baseline exposures from open-top vapor degreasing are the same as
those from conveyorized vapor degreasing). Given the uncertainty
over the actual exposure level associated with each equipment
type, the reduction in exposure (and risk) achieved by installing
a particular control may be presented with more accuracy as the
percentage of reduction achieved rather than as an absolute
value.
Consumer Exposure and Controls (Exposure assessments based
primarily on modelling of summary statistics from consumer use
and shelf survey)
Paint Stripping (Methylene Chloride)
1. The Consumer Exposure Committee plans to provide data on
baseline (current use) exposures and the number of consumers
exposed at the product level once use and survey data are
received and analyzed. The Committee will provide
quantitative exposure reduction information associated with
-39-
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control measure currently under consideration, namely
ventilation and outdoor use. If reformulation becomes an
option, CPSC plans to ask product companies to provide
testing on exposures to new products.
A determination of the effectiveness of product
. labelling and informtion control options will require a
follow-up consumer use survey in 1988 to evaluate the extent
to which consumer paint stripping behavior changes. Such a
survey is planned but not budgeted. It could cost
approximately $100,000.
Aerosols (All Six Halogenated Solvents)
1. The Consumer Exposure/Control Committee expects to provide
data on exposure and the number of people exposed to consumer
aerosol products (excluding pesticides), based on surveys
conducted at the product level. They expect data on aerosol
paints to be the most reliable; there is some uncertainty
about the make-up of other types of products (i.e., the
amount of solvents contained in these products). The
Committee currently has no plans to generate exposure
reduction data for control options for aerosols. Industry
(the National Paints and Coating Association) has informed
CPSC that methylene chloride will be taken out of all
consumer aerosol products with the possible exception of some
"commercial" automotive products by 1987.
The Committee should be able to provide data on current
exposures to methylene chloride from use as an inert
ingredient in pesticide products by December 1, 1986. OPP
will estimate the extent of exposure to methylene chloride as
a pesticide inert by collecting information on product
composition, use and production volume. Methylene chloride
is currently contained as an inert in roughly 1,040 pesticide
products, and its use appears to be on the rise.
Implication for Risk Assessment and Options Selection
At present, the Consumer Exposure/Control Committee is
focusing options selection and risk reduction analysis solely on
methylene chloride paint stripping exposures. The only control
measure currently under consideration is labelling to encourage
use of paint strippers outdoors or in a highly ventilated area.
Consideration of other options (such as reformulation) are
planned but not budgeted.
-40-
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The Consumer Exposure Committee has not yet budgeted funds
for considering control options for consumer aerosol products.
As noted above, industry has proposed voluntarily removing
methylene chloride from aerosol products by 1987. However, we
may not yet want to assume that all formulators will voluntarily
remove methylene chloride from their aerosol products or that
this woul'd be the most desirable outcome. The Committee will
need to consider the possibility of substitution of other
solvents, at least for certain products (the major product,
aerosol paints, will likely be reformulated without substituting
one of the other solvents).
Substitution may also be an issue for pesticide aerosol
products. Initiation of work on control measures for pesticides
will depend upon the Committee findings on the extent of exposure
to methylene chloride as a pesticide inert. OPP may generate
exposure reduction data on aerosol pesticide products depending
upon the results of their pesticide exposure analysis.
Ambient Air Exposure and Controls (Exposure assessment based on
modelling data.)
Metal Cleaning (Methylene Chloride, Perchloroethylene,
Trichloroethylene)
1. The Ambient Air Exposure Committee's initial emissions
estimates (available in early June) will be across all
equipment types (i.e., not broken out). However, the
Committee plans in the next several weeks to break out their
exposure analyses by the three types of cleaning equipment,
specifically cold cleaning, vapor degreasing and conveyorized
degreasing (release rates and control technology vary by
equipment type). OAQPS's emissions estimates are currently
based on 1) consumption data supplied by HSIA and 2) ten-
year-old data for allocating consumption to the three types
of cleaning equipment. The Economics Committee has agreed to
supply OAQPS with their revised metal cleaning consumption
levels to give OAQPS an updated breakdown among equipment
types.
2. The Economics Committee's consumption figures will also be
broken down to the 3- and probably 4-digit SIC Code level
since that level of detail is required for the substitution
analysis. OAQPS plans to develop emission estimates and
exposure estimates based on a 2-digit aggregation.
-41-
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3. OAQPS will also supply estimates of costs and emission
reduction efficiency broken out by equipment controls.
4. ETD has requested that OAQPS break out the total exposure
from counties already controlling VOC emissions for one or
more of the solvents from those counties which do not. It is
OTS's understanding that OAQPS has agreed to do this.
Paint Stripping and^ Aerosol Use
1. Time limitations at the meeting did not permit discussion of
the paint stripping and aerosol use categories for ambient
air exposures. However, OTS (but not OAQPS} plans to develop
ambient emissions data for consumer products.
2. OTS cannot provide data on ambient emissions from
industrial/commercial (as opposed to consumer) use of
aerosols and paint stripping. These use categories are
significant {80% of total use) for paint stripping.
Implications for Risk Assessment and Options Selection
1. If OAQPS relies on consumption data supplied by HSIA and uses
old allocation data it may cause some problems: (1) some
concerns have been raised that two SIC codes in which metal
cleaning is generally known to take place are not in the HSIA
listing, and (2) the distribution of equipment types may be
unreliable.
Apparently, the first problem may not be serious for ambient
exposure estimates, since the HSIA estimates in effect
redistribute the missing SIC code consumption (less than
fifteen percent of the total in any case) volume into the
other categories. Since most of the sources are area sources
(as would be the missing SIC codes), the most serious issue
is whether the geographical distribution of the missing SIC
code sources is consistent with the other five categories.
The Economics Committee is currently developing a breakdown
of metal cleaning consumption that is more detailed than the
2-digit SIC code listing provided by HSIA. The new
consumption data will provide a current basis for allocating
consumption by equipment type. The data may also provide
more information on the significance of consumption levels in
SIC codes other than those listed by HSIA. However,
development of these data will probably add several weeks to
the schedule for delivery of the ambient exposure estimates.
-42-
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Development of emission and exposure estimates based on
2-digit aggregation rather than on a 3- to 4-digit level
could be an issue if the geographic distribution of 4-digit
sources that substitute versus those that do not is for some
reason significantly different from the distribution implied
at the 2-digit level. OAQPS did not think that this was a
s-ignificant issue and indicated that substantial resources
(80-100 extramural hours) would be required to provide
greater levels of detail.
OAQPS has not scheduled work on any solvents other than
methylene chloride, perchloroethylene and trichloroethylene,
nor have they scheduled work on the paint stripping or
aerosol use categories. This is inconsistent with work
ongoing on the Occupational and Consumer Exposure Committees,
as well as the Health/Risk, Economics, and Project Management
Committees.
Lack of ambient air emissions data on methyl chloroform,
carbon tetrachloride and CFC-113 will prevent a determination
of the role of ozone depletion in the integrated risk
assessment.
OAQPS has not yet scheduled work for analyzing the effects of
substitution (i.e., analyzing the ETD model results available
in mid-late summer). This could lead to a delay in the
overall schedule.
cc: E. Brooks
K. Blanchard
S. Wyatt
S. Eberk
J. Vorbach
P. Kennedy
L. Hall
J. Blancato
H. Call
B. Massouda
D. Beck
_43_
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APPENDIX D
PARTICIPANTS IN CHLORINATED SOLVENTS EFFORT
Project Management Committee
Regulatory Options Committee
*Ed Brooks
**Sherry Sterling
**Susan Hodges
**Emery Lazar ^
**Peter Principe
**Rebecca Torchia
Dave Patrick (K. Feith, alt.), OAR
Hugh Spitzer, ORD
Al Jennings, OPPE
Elizabeth LaPointe (J. Sales, alt.), OSWER
Alan Corson, OSWER
Carole Gray, OPP
Charles Gregg, CW
Ron Lorentzen, FDA
Ruth Bell, OGC/Regulatory Options Comm.
Rich Gross, OSHA/Occupational Comm.
Sandra Eberle, CPSC/Consumer Comm.
Bob Lee, OTS/Economics Comm.
Jerry Blancato, Hazard/Risk Assessment Comm.
Susan Wyatt, Ambient_Air Exp. Comm.
Peter Principe, Integration Report Comm.
Ambient Air Exposure Committee
*Susan Wyatt, OAR
Loren Hall, OPTS
Dev Barnes /Tom O'Farrell, OW
Bob Fegley, OPPE
Economics Committee
*Bob Lee, OTS
Don Eckerman, OPP
Debra Maness, OW
Glen Simpson, CPSC
Hugh Conway, OSHA
(Chun, Stern, Conner, alts.)
Ronn Dexter, OPPE
Tom Walton, OAR
Consumer Exposure Committee
*Sandra Eberle, CPSC
Pat Kennedy, OTS
Karen East, OPPE
Oscar Hernandez, OPP
Key: * Committee Chairperson
** PMC Staff
*Ruth Bell, OGC
Emery Lazar, OTS
Geoff Grubbs, OW
Joan Warshawsky, OPP
Ronn Dexter, OPPE
Ken Feith, OAR
Harleigh Ewell, OSHA (Henschel, alt.)
Rich Gross, OSHA (Henschel, alt.)
Hazard/Risk Assessment Committee
*Jerry Blancato, ORD
Jane Hopkins, OTs
(Romberg, alt.)
Pat Roberts, OGC
Arnie Kuzmack, OW
Gary Burin, OPP
Karen East, OPPE
Karen Blanchard, OAR
Rich Gross, OSHA (Gass,
Edens, alts.)
Murray Cohen, CPSC
Occupational Exposure Committee
*Rich Gross, OSHA (Conway,
Stern, Chun, alts.)
Bill Burch, OPTS
James Wheeler, OW
Karen East, OPPE
Oscar Hernandez, OPP
Integration Report Committee
*Peter Principe, OTS
Bob Scarberry, OSWER
Alan Corson, OSWER
Paul Stolpman, OAR
Vivian Thomson, OAR
Carole Gray, OPP
Elissa Feldman, ORD
Ronn Dexter, OPPE
Sandra Eberle, CPSC
Rich Gross, OfiHA
Charles Greggj,*\OW
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