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TOXIC SUBSTANCES
Chemical Testing and Assessment
Amendment/
Current
Actual Estimate Estimate
Major Output/Milestones 1983 1984 1985
Develop and Validate Test Methods
- Provide a testing protocol for rapid 10/86 10/86 10/86
assessment of reproductive damage
(Health)
- Provide testing protocols to screen 9/86 9/86 9/86
and evaluate chemicals for immuno-
toxic effects (Health)
- Provide reports on comparison of 10/85 10/85 10/85
hazard rankings of chemicals based
on model ecosystems and single
species effects (Environmental
Processes)
- Provide report on improved system- 12/86 12/86 12/86
level process tests to indicate
potential effects of chemicals
in freshwater (Environmental
Processes)
- Provide report on laboratory-to-field 6/85 6/85 6/85
extrapolation of toxic stress on
estuari ne macrobenthic communities
(Environmental Processes)
Develop and Validate Methods to
Predict and Monitor Exposure
- Complete final report on Phase II 3/85 3/85 3/85
of TEAM study of exposure to toxic
organics in three cities
(Monitori ng)
- Develop a cancer test battery for 9/87 9/87 9/87
human risk estimation (Health)
- Provide report on exposure 4/85 4/85 4/85
assessment in estuari ne systems
(Environmental Processes)
TS-13
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Amendment/
Current
Actual Estimate Estimate
Major Out put/Mi lest ones 1983 1984 1985
- Provide report on bi odegradation 4/85 4/85 4/85
predictions from microcosm
screening and eco-core systems
(Environmental Processes)
- Provide report on atmospheric 5/85 5/85 5/85
pollutant field tracer
(Environmental Processes)
Develop and Validate Risk Assessment
Methods
- Provide improved mathematical models 10/84 10/84 10/84
of pollutant deposition in the lung
(Health)
Perform Engineering and Scientific
Evaluations and Assessments
- Submit draft exposure guidelines 9/83
to SAB (Scientific Assessment)
- Complete draft of biomonitoring 12/84 12/84 12/84
guidelines (Scientific Assessment)
- Provide workshop report on bi ode- 6/84 6/84
gradation of toxic chemicals
(Environmental Processes)
Develop Predictive Techniques in Support ~
of Premanufacture Notice Reviews
- Provide a combined data management 9/86 9/86 9/86
system for genotoxic chemicals
(Health)
- Provide report on a comprehensive 9/85 9/85 9/85
structure-toxicity method to
estimate toxicity of chemicals
to aquatic organi sms
(Environmental Processes)
- Provide report on the chemicals 9/84 9/85
release and exposure from unit
operations and unit processes
(Environmental Engineering)
- Report on the treatability of 9/84 9/85
azo dyes (Env. Engineering)
Evaluation of Environmental Control
Measures for Existing Chemicals
- Provide report on the causes, controls 12/84 12/85
and detection of leaks in underground
storage tanks (Env. Engineering)
TS-14
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TOXIC SUBSTANCES
Chemical Testing and Assessment
Budget Request
The Agency requests a total of $27,103,200 supported by 193.3 total workyears
for 1985, an increase of $2,677,200 and 4.4 total workyears from 1984. Included
in this is $12,638,400 for Salaries and Expenses and $14,464,800 for Research and
Development, with an increase of $487,800 and $2,189,400 respectively. The major
increases occur in the development of exposure monitoring methods, quality assurance
and in the initiation of methodologies for evaluating environmental risks associated
with bi oengi neered organisms.
Program Description
The Chemical Testing and Assessment research and development program supports
the Office of Toxic Substances (OTS) by providing the scientific tools to implement
the Toxic Substances Control Act (TSCA). The major needs and objectives of EPA's
toxic substances research efforts which support TSCA activities are as follows:
Objective 1. Develop and Validate Test Methods That Identify and Assess
Health and Environmental Hazards of Chemicals Under TSCA. The purpose of thi s
objective is to develop and validate environmental and human health effects tests.
OTS publishes test guidance to assure that industry test data will adequately
identify and assess potential environmental and health hazards due to exposure
from chemicals.
Objective 2. Develop and Validate Methods to Predict and Monitor Human and
Environmental Exposure to Chemicals Under TSCA. Tfte -research -•} denti f i es major
transport and transformat1'on~proce!;ses~and~deveJlops~TrtrH-dated mode+s and monitoring
methods and data bases so that the Agency can document and estimate human and
environmental exposures to chemicals.
Objective 3. Develop and Validate Improved Risk Assessment Methods for TSCA
Studi es. Fhe effort develops health risk assessment methods that are more reliable
and economical than existing methods and develops methods necessary to evaluate
major health effects for which no adequate assessment methods exist.
Objective 4. Perform Engineering and Scientific Evaluations and Assessments
and Control Quality of Agency Ri sk ^Assessment sJ This objective provides scien-
tific evaluations and assessments to OTS on monitoring and risk assessment problems
and develops defensible methods to estimate the value of adverse health and envi-
ronmental impacts related to the production, use and disposal of chemicals.
Objective 5. Develop Predictive Techniques in Support of Premanuf acturi ng and
New Use Revi ews. The purpose of t hi s research is to develop predictive methods
including structure-activity relationships (SAR) to provide a tool to determine
whether a new chemical poses unreasonable risk or needs additional testing.
Objective 6. Develop Methods and Provide Quality Assurance for TSCA Data and
Analyti cal Acti viti es. Thi s object! ve supports research to improve measurement
methods, fi eld monitor! ng systems and associated quality assurance protocols.
Reference banks and audit programs to assess laboratory and field performance are
also maintained to assure the quality of data.
TS-15
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Objective/. Evaluation of Environmental Control Measures for Existing
Chemicals. This effort evaluates the release of chemicals in the workplace and to
the envi ronment and assesses measures to limit the release of and exposure to
chemicals.
Objectives. Assess Stratospheri c Modi ficati on. The purpose of this effort
is to investigate the health and environmental consequences of lower levels of ozone
and anticipated increased exposure to ultra-violet radiation. The Clean Air Act
Amendments of 1977 require assessment of the environmental and health effects of
stratospheric modification due to changes in the ozone layer.
SCIENTIFIC ASSESSMENT
1985 Program Request
The Agency requests a total of $276,300 supported by 4.0 total workyears for
this program, of which $225,300 is for Salaries and Expenses and $51,000 is for
Research and Development. This represents an increase of $55,000 in Salaries and
Expenses and a decrease of $24,000 in Research and Development. The overall in-
crease of $31,000 reflects additional efforts to evaluate the use of metabolism
studies for exposure assessment.
Perform Engi neering and Scientific Evaluations and Assessments and Control
Quality of Agency Risk Assessments. Methods will be defined to compare metabolism
pathways in test animals and humans. Exposure and risk assessments will continue
to be reviewed and portions of assessments will be conducted where specialized ex-
pertise is required. Assessment methods will be reviewed and modified to address
program specific problems.
1984 Program
In 1984, the Agency is allocating a total of $245,300 and 4.0 total workyears
to this program of which $170,300 is under the Salaries and Expenses appropriation
and $75,000 is for extramural purposes under the Research and Development appro-
priation.
Perform Engineering and Scientific Evaluations and Assessments and Control
Quality of Agency Risk Assessments. Exposure and ri sk assessments are bei ng re-
vi ewed to assure that program specific problems are adequately addressed. Portions
of assessments are being conducted where specialized expertise is required. Expo-
sure and risk assessment methods are being reviewed and modified.
1984 Explanation of Changes from the Amendment
There is no change from the amendment.
1983 Accomplishments
In 1983, the Agency obligated a total of $422,000 for this program, of which
$102,100 was under the Salaries and Expenses appropriation and $319,900 was for
extramural purposes under the Research and Development appropriation.
Perform Engineering and Scientific Evaluations and Assessments and Control
Quality of "Agency Risk Assessments. Exposure assessment guidelines and handbooks
were revised in accordance with Science Advisory Board review comments. Further
changes in the exposure handbook were recommended by an extramural peer panel. The
guidelines were resubmitted for final disposition to the Science Advisory Board.
TS-16
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MONITORING SYSTEMS AND QUALITY ASSURANCE
1985 Program Request
The Agency requests a total of $5,599,000 supported by 27.1 total workyears
for this program, of which $1,872,900 is for Salaries and Expenses and $3,726,100
is for Research and Development. The increases of $167,900 and $870,000, respec-
tively, reflect initiatives in the areas of quality assurance in support of PCB
regulations and methods development for measuring organics, particularly azo dyes.
Develop and Validate Methods to Predict and Monitor Human and Environmental
Exposure to Cherni cals Under TSCA. Methods to measure human exposure and food
chain pollutant concentrations will be tested at a field site to be established in
an urban area. Initial design work to establish a World Health Organization Health
Exposure Assessment Laboratory (WHO/HEAL) will begin. Improved statistical tools
to aid in spati al/temporal analysis will continue to be developed. This research
supports OTS in its assessment and regulations of existing chemicals.
Develop Methods and Provide Quality Assurance for TSCA Data and Analytical
Acti vities. The Agency continues to foster new and improved measurement methods
and quality assurance. Additional resources in this area will be used to adapt
High Performance Liquid Chromatography (HPLC) and coupled mass spectrometers
(MS/MS) to measure atmospheric organics, particularly azo dyes, a class of chemi-
cals with which there is concern about potential high toxicity. Methods are also
. b_ei ng devel oped and evaluated for sampling and analyzing volatile organic compounds
which are currently difficult to isolate.
The increase in the quality assurance (QA) area will be used to initiate a QA
program in support of PCB regulations. Other activities include development of
quality assurance protocols and guidelines for chemical and biological measurements.
1984 Program _._
In 1984, the Agency is allocating a total of $4,561,100 and 27.1 total work-
years to this program of which $1,705,000 is for Salaries and Expenses and
$2,856,100 is for extramural purposes under Research and Development.
Develop and Validate Methods to Predict and Monitor Human and Environmental
Environmental Exposure to Chemicals Under TSCA.The exposure monitoring research
effort emphasizes developi ng (T] monitori ng data directly related to exposure
measurements to corroborate the limited laboratory and model data used in risk
assessment, and (2) monitoring systems and approaches capable of linking environ-
mental concentrations of chemicals to human exposure. A field test to evaluate
exposure monitors, sampling protocols and data analysis techniques developed in
prior years is being initiated. The program is developing improved statistical
tools to aid in the design and analyses of exposure monitoring programs.
Develop Methods and Provide Quality Assurance for TSCA Data and Analytical
Acti viti es. We are continuing research on various cryogenic approaches and new
collector materi als for sampling heavier compounds in air; and a number of direct
methods for analysis of organic compounds contained in parti cul ate matter are
being examined. The quality assurance area is emphasizing protocols for biological
measurements, and field work is being conducted to develop guidelines that will
be used in validating soil models. Finally, a protocol and report on assessing
asbestos fiber reduction techniques is being published and laboratory audits are
being conducted as needed and a standard reference bank for material spectra is
bei ng mai ntai ned.
TS-17
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1984 Explanation of Changes from the Amendment
The net decrease of -$11,000 results from the following action:
-Reprogrammi ng. (-$11,000 ) A reprogrammi ng was made to this activity which
was not report able under the Congressional reprogrammi ng limitations. This change
resulted in a net decrease of -$11,000 to the Salaries and Expenses appropriation.
1983 Accomplishments
In 1983, the Agency allocated a total of $5,215,700 and 27.1 total workyears
to this program, of which $1,634,900 was under the Salaries and Expenses appro-
priation and $3,580,800 was for extramural purposes under the Research and
Development appropri ation.
Develop and Validate Methods to Predict and Monitor Human and Environmental
Exposure to Chemicals_Under TSCA.The Agency collected datafrom thesecond
city of the two cTtyTotal Exposure Assessment Methodology (TEAM) Study. The
data will be used to evaluate the effectiveness of using personal dosimeters,
biological samples, and population activity questionnaires to obtain improved
exposure data in humans. The Agency initiated development work on a number of
improved statistical approaches and data handling techniques for predicting and
monitori ng human and environmental exposure to chemicals. In addition technical
assistance for a number of Agency exposure assessments was provided.
Develop Methods and Provide Quality Assurance for TSCA Data and Analytical
Acti viti es.Methods Tor sampli ng and analyzi ng volati 1 e organic compounds were
tested. Guidelines that will be used in the field validations of stream models
that predict fate and transport of chemical compounds also were completed. The
audit program for the asbestos in schools program continued, and quality assurance
protocols and standard reference materials were provided for a number of studies
and fi eld acti viti es.
HEALTH EFFECTS
1985 Program Request
The Agency requests a total of $10,835,000 supported by 59.1 total workyears
for this program, of which $3,813,000 is for Salaries and Expenses and $7,022,000
is for Research and Development. This reflects a decrease of $44,200 in Salaries
and Expenses and an increase of $359,100 for Research and Development for an over-
all increase of $314,900. The increase will focus on identifying areas to which
epidemiology studies may be applied as well as development of risk methods for
new chemi cal s.
Develop and Validate Testing Methods That Identify and Assess Health and
Environmental Hazards of Chemi cal s Under TSCA. Health effects test guidelines are
needed for test FuTes speci fied under Section 4 of TSCA to define testing data
deficiencies under Section 5, and to meet the statutory requirements of Section
10(e). Existing guidelines contain deficiencies and gaps that must be addressed if
we are to provide reliable, scientific guidance to industry for test rule develop-
ment. Laboratory animal, tissue, and organ culture methodologies will be devel-
oped to provide more sensitive, reliable and efficient procedures to assess bio-
medical endpoints. Work will focus on two areas of concern to OTS: inexpensive
and short-term screening tests, and longer-term tests and systems for the tier-
testing matrix. This research includes emphasis on the relationship of animal
test data to human systems.
TS-18
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Develop and Validate Improved Risk Assessment Methods for TSCA Studies.
Additional resources in 1985 will be used to address some of the significant gaps
in the risk assessment methodologies. Current methodologies, for the most part,
have been essentially limited to cancer risk and many of the existing methodologies
are i ncompletely validated. Both qualitative and quantitative procedures need to
be improved to extrapolate data from animal studies to human risk. Epidemiology
research will also be expanded to assess areas where epidemiology data may be
appli ed.
Perform Engineering and Scientific Evaluations and Assessments and Control
Quality of Agency Risk Assessments^OTS performs evaluations of exposure to cherni-
cal s and assesses the risk that can result from such exposure. Scientific assess-
ments and data collection support this process. This research will provide data on
the adverse effects of inhaled asbestos and asbestos like fibers including the cor-
relation of short-term tests with in vivo carcinogenesi s studies. In addition, EPA
will investigate the health effects of speci fic commerical mineral fibers such as
those coming from automotive brake pads.
Develop Predictive Techniques in Support of Premanufacturi ng and New Use Re-
vi ewsT Estimates of health effects are part of the PMN reviews under Section 5 of
TSCA. We will conti nue to emphasize development of structure-activity relationship
(SAR) models. SAR will also improve OTS's ability to limit testing of existing
chemicals to the necessary tests. The objective of this research is to develop a
method which can use data on molecular descriptors or combinations as a screening
tool to predict genetic and carcinogenic activities and prioritize chemicals for
further testing; and to construct a chemical data base in several areas of toxico-
logical response related to individual organ systems. Work will also begin on
computer assisted predictive metabolism and hazard estimation of toxic chemicals
using the Gene-Tox computerized data base. This effort will provide quantitative
health hazard assessments together with quantitative j_n vitro and animal test data
suitable for use by OTS in health risk assessment.
1984 Program
In 1984 the Agency is allocating a total of $10,520,100 and 59.1 total work-
years to this program of which $3,857,200 is under the Salaries and Expenses appro-
priations and $6,662,900 is for extramural purposes under the Research and Develop-
ment appropriation.
Develop and Validate Test Methods That Identify and Assess Health and Environ-
mental Hazards of Chemicals Under TSCTA.rhe test method development program focuses
on development of inexpensive and short-term screening tests and of longer-term
tests and systems for tier-testing to a variety of biomedical indices. This
research includes emphasis on the relations of animal test data to human systems.
Develop and Validate Improved Ri sk Assessment Methods for TSCA Studies. Ri sk
assessment methodologies are being developed and validated for improved qualitative
and quantitative extrapolation of animal data to human risk in the areas of mutagen-
icity, carci nogenticity. neurotoxi city, adverse reproductive effects and teratology.
Perform Engineering and Scientific Evaluations and Assessment and Control
Quality of Agency Risk Assessments.Work is continuing on the data baseFoF
asbestosand asbestos like fibers, including the correlation of short-term tests
wi t h i n vi vo carci nogenesi s studies. Ue are also providing technical and logistic
support to the Interagency Task Force on Environmental Cancer and Heart and Lung
Di sease.
Develop Predictive Techniques i n Support of Premanufacturi ng and New Use
Revi ews"I Structure-Activity Relationships (SAR) research continues on the develop-
ment of toxi cologi cal data bases to develop models for predicting carcinogenic,
mutagenic, reproductive, neurotoxic, pulmonary, renal, hepatic, and cardiovascular
effects. Mathematical and computer modeling work is also being conducted in
support of this objective.
TS-19
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1984 Explanation of Changes from Budget Estimate
The net decrease of -$28,500 results from the following action:
-Reprogramnri ng. (-$28,500) A reprogramnri ng was made to this activity which
was not report able under the Congressional reprogrammi ng limitations. This change
resulted in a net decrease of -$28,500 to the Research and Development appropria-
tion.
1983 Accomplishments
In 1983 the Agency obligated a total of $7,914,200 for this program, of which
$4,206,400 was under the Salaries and Expenses appropriation and $3,707,800 was for
extramural purposes under the Research and Development appropriation.
Develop and Validate Test Methods That Identify and Assess Health and Environ-
mental Hazards of Chemicals Under TSCA.In 1983, the Agency's accomplishments in-
cluded publication of a series of papers on the use of short-term test systems
using human cells as the targets and a series on the use of short-term tests to
evaluate the effects of combinations of pollutants.
Perform Engineering and Scientific Evaluations and Assessments and Control
Quality of Agency Risk Assessment si In 1983 the Agency's accomplishments included
publication of a study on occupational exposure to formaldehyde.
Develop Predictive Techniques in Support of Premanufacturing and New Use Re-
vi ews. In 1983 the Agency's accomplishments included publication of studies on
structure-activity relationships for two types of chemicals.
ENVIRONMENTAL ENGINEERING AND TECHNOLOGY
1985 Program Request
The Agency requests a total of $678,000 supported by 8.0 total workyears for
this program, of which $478,000 is for Salaries and Expenses, and $200,000 is for
Research and Development. This reflects an increase of $280,900 for Salaries and
Expenses, and an increase of $200,000 for Research and Development, for an overall
increase of $480,900. The increased resources will improve the Agency's ability
to predict the potential for release of and exposure to new chemicals and evaluate
control measures for existing chemicals.
Perform Engineering and Scientific Evaluations and Assessments and Control
Quality of Agency Risk Assessments. Two types of assessments will be conducted to
support the efforts of OTS in the premanufacturing notice review of genetically
engineered organisms. First, an assessment of the potential for environmental
cont ami nation wi 11 be conducted. Also to be undertaken is an assessment of the
physical, chemical, and biological techniques and devices for the containment and
destruction of genetically engineered organisms.
Develop Predictive Techniques in Support of Premanufacture Notice Reviews.
Models to predict the release and exposure of different classes of chemicals will
be developed. This will meet the Agency's needs for predictive capabilities in
assessing release and exposure of chemicals in the review of premanufacture notice
for new chemicals as required by the Toxic Substances Control Act. Pilot scale
evaluations of the treatability of classes of potentially toxic substances by
waste treatment systems will be conducted to verify the developed predictive models.
The chemicals studied will be chosen from the classes which appear frequently in
the premanufacturing notice (PMN) process.
TS-20
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Evaluation of Environmental Control Measures for Existing Chemicals.
Ways to mitigate the release of and exposure to specific existing chemicals will
be initiated. This will be accomplished by evaluating and adapting control measures
related to the release in the work place and Into the environment of the chemicals
during their life cycles. Techniques, management practices, and personal pro-
tection equipment to limit the release and exposure of chemicals will be evaluated.
1984 Program
In 1984, the Agency is allocating a total of $197,100 and 6,0 total workyears
to this program, all of which the is under the Salaries and Expenses Appropriation.
Develop Predictive Techniques in Support of Premanufacture Notice Reviews.
The development of models to predict the release and exposure of new chemicals is
being undertaken. Pilot scale evaluation of the treatability of new potentially
toxic substances such as azo dyes by waste treatment systems are being conducted.
The results from these evaluations will be utilized to verify the developed
predictive models.
Evaluation of Environmental Control Measures for Existing Chemicals. Evalua-
tions of environmental control measures for existing chemicals are being conducted.
An engineering assessment of the amount of release and contamination of groundwater
from underground storage tanks has been started. A model to predict the effective-
ness of chemical protective clothing materials is being developed.
1984 Explanation of Changes from the Amendment
The net decrease of -$70,000 results from the following action:
-Reprogramming. (-$70,000) A reprogramming was made to this activity which
was not reportable under the Congressional reprogramming limitations. This change
resulted in a net decrease of -$70,000 to the Salaries and Expenses Apjjrcqjrialloru
1983 Accomplishments
In 1983, the Agency obligated a total of $556,900 and 7.7 total workyears for
this program, of which $359,500 was under the Salaries and Expenses appropriation
and $197,400 was for extramural purposes under the Research and Development appro-
priation.
Perform Engineering and Scientific Evaluations and Assessments and Control
Quality of Agency Risk Assessments'. Process specific information and engineering
assessments have been provided to estimate release and exposure of new toxic sub-
stances in the pre-manufacture notice review process. The life cycle emissions
and release studies of dye stuffs have been conducted and scheduled for publication
in 1985.
ENVIRONMENTAL PROCESSES AND EFFECTS
1985 Program Request
The Agency requests a total of $8,837,400 supported by 93.3 total workyears
for this program, of which $6,114,100 is for Salaries and Expenses and $2,723,300
is for Research and Development. This represents a decrease of $25,800 in the
Salaries and Expenses appropriation and an increase of $783,300 in the Research
and Development appropriation. The increased resources will initiate a new re-
search program on biotechnology which is concerned with the development of method-
ologies for evaluating environmental risks associated with bioengineered organisms.
TS-21
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Develop and Validate Test Methods That Identify and Assess Health and Environ-
mental Hazards of Chemicals Under TSCA. The environmental hazards assessment
program i s designed to develop, i mprove, and validate single-and multiple-species
toxicity testi ng methods. Focus will be on the acceleration of benthic assays
development, development of culturing techniques, and initiation of work on hazard
ranking of chemicals based on single-species and ecosystem effects. Terrestrial
toxicology research will continue to focus on the effects of chemicals on both
plant and avian species, with emphasis on validation of test methods. The compara-
tive toxicology program is designed to define how much testing is needed for an
adequate risk assessment when one species can be used to test and predict adverse
effects for other species. Comparative toxicology relationships on a diverse
phyla of marine organisms as well as on avian vs. wild species will be developed.
System-level research, conducted on the effects of toxic chemicals on aquatic and
terrestrial ecosystem processes and functions, will focus on tests related to
freshwater as well as for benthic marine species. There wi 11 be a continuing effort
to develop the criteria for determining the limits of applicability of toxicological
data obtained in the laboratory to field situations.
Develop and Validate Methods to Predict and Monitor Human and Environmental
Exposure to Chemicals Under TSCA. The envi ronmental exposure assessment program
will focus on development, improvement, and validation of mathematical models for
exposure assessments in air, water, and terrestrial systems, in food chains, and
i n multi-medi a environments. Basic scientific understandings, concepts, and data
will be acquired on transport and fate mechanisms to develop defensible laboratory
test methods and exposure models for evaluating the environmental fate and multi-
media distribution of chemicals. Emphasis will be placed on evaluating mathematical
models under various simulated and actual field conditions to estimate their preci-
sion, accuracy, and confidence limits in real-world environments.
Develop and Validate Improved Ri sk Assessment Methods for TSCA Studies. In
1985, the environmental processes and effects program will initiate a new program
on biotechnology aimed at providing tools to OTS for evaluating the environmental
risk associated with genetically engineered organisms under PMN review. Work will
focus on developing scientific rationales and procedures for evaluating transport
and survi vabi li ty of genetically manipulated organisms (microbes, plants, or
animals).
Perform Engineering and Scientific Evaluations and Assessments, and Control
Quality of Agency Risk Assessments^ Technical studies wi 11 be conducted for OTS
on envi ronmental fate, exposure, effects, hazard, and environmental risk of
chemicals. Specific examples include: review and screening of new chemicals for
Section 5 of TSCA; development and revision of test rules; and management of work-
shops on technical issues of particular importance to OTS.
Develop Predicti ve Techniques in Support of Premanufacturing and New Use Re-
vi ews: In 1985, work on the development of SAR models for predicti ng the environ-
mental fate and toxicity of chemicals will continue with emphasis on validating of
models and improving the precision and reliability of methods. Specifically, the
program will: 1) develop data sets and correlation models for the prediction/
estimation of fate and effects based on chemical structure; 2) determine the feasi-
bility of using chemical similarity indices to identify potentially hazardous PMN
chemicals; and 3) develop methods for the possible estimation of acute and chronic
effects on organisms SAR.
1984 Program
In 1984, the Agency is allocating a total of $8,028,300 and 90.9 total work-
years to this program, of which $6,088,300 is under the Salaries and Expenses
appropriation and $1,940,000 is for extramural purposes under the Research and
Development appropriation.
TS-22
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Develop and Validate Test Methods That Identify and Assess Health and Environ-
mental Hazards of Chemicals Under TSCA.The environmental hazards assessment
program is designed to develop, improve, and validate test methods, for defining
hazards to ecosystems. Work on terrestrial plant uptake and metabolism will be
completed. Tests will be developed on a diverse phyla of marine organisms to
develop comparative toxicological relationships. System-level research, necessary
because effects estimates based upon single species data may not accurately define
the hazard to larger ecosystems, is continuing. Work on defining critically
sensitive terrestrial/forest ecosystems which are vulnerable to toxic chemicals
will be completed. Laboratory-scale simulated environmental systems will be
used to validate effects methods. This will be the first attempt to develop the
criteria for determining limits of applicability of laboratory-derived toxicological
data for certain kinds of aquatic communities and the first step in defining a
quantitative relationship between the data obtained in the laboratory with field
situations.
Develop and Validate Methods to Predict and Monitor Human and Environmental
Exposure to Chemicals Under TSCA.Work continues to identify transport and trans-
formation processes and to develop mathematical models and data bases needed to
estimate ambient concentrations of toxic substances in various environmental media.
The main emphasis on this topic, however, has shifted to microcosms and field valid-
ation of previously developed methodologies to determine applicability in real sit-
uations.
Perform Engineering and Scientific Evaluations and Assessments, and Control
Quality of Agency Risk Assessments. ORD scientists continue to respond to technical
assistance requests from OTS. It is expected that these requests, as in previous
years, will include: toxicity screening and evaluation of newly introduced chemi-
cals; development of test guidelines for specific chemicals of concern; development
of additional sets of support documents for new test guidelines; and management of
technical workshops on newly emerging topics of interest to OTS.
Develop Predictive Techniques in Support of Premanufacturing and New Use Re-
vi ews. Efforts continue in developing structure-activity models as a means for
estimati ng toxicity and fate of PMN chemicals in the environment. This research
includes development of models for defining bi oaccumulation, toxicity, distribution
coefficient, thermodynamic properities, and data bases on plant uptake, fate and
reactivity of chemicals, and toxicity to freshwater and marine species.
1984 Explanation of Changes from the Amendment
There is no change from the amendment.
1983 Accomplishments
In 1983, the Agency obligated a total of $9,818,000 for this program, of
which $6,254,000 was under the Salaries and Expenses appropriation and $3,564,000
was for extramural purposes under the Research and Development appropriation.
Develop and Validate Test Methods that Identify and Assess Health and Environ-
mental Hazards of Chemicals Under TSCA. Test methods development projects com-
pleted in 1983 provided both single-species and microcosm testi ng results, final data
on the isolated root uptake of chemicals, and information on the comparative toxi-
city of 10 chemicals to selected species of aquatic organisms.
Develop and Validate Methods to Predict and Monitor Human and Environmental
Exposure to Chemicals Under TSCA. In 1983 the following outputs were produced: a
user's manual for EXAMS II; an organic, multi-media environmental exposure screening
model; and a heavy metal transport, fate, and exposure model. Studies were also
completed on the accumulation of toxic substances in estuarine food chains and
microbial degradation rates; and atmospheric pollutant tracer field experiments.
TS-23
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Perform Engineering and Scientific Evaluations and Assessments, and Control
Quality of Agency Risk Assessments. Major technical assistance was provided to OTS
by expert reviews of testing guidelines, Section 4 test rule determinations, and
other documents.
Develop Predictive Techniques in Support of Premanufacturing and New Use
Revi ews. Th"estructure-activity program completed a generi c c las si fi cat ion oT
chemicals in the TSCA inventory list based upon structural characteristics. Also
completed were models for several classes of chemicals to evaluate potential toxi-
city to fish; applicability of freshwater SAR models to indicate bi oaccumulation
and toxicity to marine species; and models to define and evaluate potential micro-
bi al degradation of chemicals in aquatic ecosystems and reaction kinetics of
ai rborne toxicants.
STRATOSPHERIC MODIFICATION
1985 Program Request
The Agency requests a total of $877,500 supported by 1.8 total workyears for
this program, of which $135,100 is for Salaries and Expenses and $742,400 is for
Research and Development. This reflects an increase of $2,400 for Salaries and
Expenses and $1,000 for Research and Development, approximately the same levels as
1984.
Assess Stratospheric Modification. The 1985 Stratospheric Modification pro-
gram will include the following: continuation of research on the adaptability of
plants to enhanced ultravi olet-B radiation and its effects on various key life
forms; coordination of Federal research in this area; and continuation of support
to the National Academy of Sciences for updating a comprehensive assessment on the
state of know! edge.
1984 Program
In 1984, the Agency is allocating a total of $874,100 and 1.8 total workyears
to this program, of which $132,700 is under Salaries and Expenses appropriation and
$741,400 i s for extramural purposes under the Research and Development appropri-
ation.
Assess Stratospheric Modification. The 1984 Stratospheric Modification
research program Ts currently: worki ng closely with the National Academy of
Sciences to assess current state of-the-art knowledge and research needs and to
provide an updated report in 1984; preparing the fourth biennial research report
to the Congress, which will be delivered in February, 1984; continuing research to
provide more definitive quantitative data on the effects to and the adaptability
of plants to enhanced ultravi olet-B radiation under field conditions; and studying
the effects of ultravi olet-B radiation on key marine life; and coordination of
Federal research in this area.
1984 Explanantion of Change from Budget Estimate
The net decrease of -$1,000 results from the following action:
-Reprogrammi ng. (-$1,000) A reprogrammi ng was made to this activity which was
not report able under the Congressional reprogrammi ng limitations. This change re-
sulted in a net decrease of -$1,000 to the Research and Development appropriation.
TS-24
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1983 Accomplishments
In 1983, the Agency obligated at total of $812,600 for this program, of which
$75,900 was under the Salaries and Expenses appropriation and $736,700 was for
extramural purposes under the Research and Development appropriation.
Assess Stratospheric Modification. The Stratospheric Modification program had
the following accomplishments in 1983. Computation of solar ultraviolet radiation
fluxes to the earth's surface as a function of latitude, season, radiation wave-
length, natural total ozone column, and percentage changes in ozone concentra-
tions was completed. A handbook of tables containing computations for use in
health, ecological effects, and assessment studies was also completed. The
program obtai ned preliminary definitive data on the effects of enhanced UV-B
radiation on crops in the field.
NATIONAL CENTER FOR TOXICOL06ICAL RESEARCH
1985 Request
The Agency is not requesting resources for pass-through funding to the National
Center for Toxicological Research in 1985.
1984 Program
Resources were not requested for this program in 1984.
1983 Program
- In 1983, the Agency obligated a total of $2,059,600, all of which was in the
Research and Development appropriation.
Activities under this program were not funded until late 1983. As a result,
major scientific outputs will not be available in this reporting period.
TS-25
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ENVIRONMENTAL PROTECTION AGENCY
1985 Budget Estimate
Table of Contents
PAGE
TOXIC SUBSTANCES TS-1
ABATEMENT & CONTROL
Toxic Substances Strategies TS-27
Toxics Integration TS-30
Chemical Testing TS-32
Existing Chemical Review TS-35
New Chemi cal Revi ew TS-38
TS-26
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TOXIC SUBSTANCES
Toxic Substances Strategies
Budget Request
The Agency requests a total of $45,418,200 supported by 471.4 total workyears
for 1985. Of these resources $20,337,500 is for the Salaries and Expenses appro-
priation and $25,080,700 is for the Abatement, Control and Compliance appropriation.
This represents an increase of 38.1 total workyears over 1984, and increases of
$2,469,800 for the Salaries and Expenses appropriation, and $3,317,400 for the
Abatement, Control and Compliance appropriation. These increases are requested
to support new initiatives and expansions of existing efforts in four areas:
Toxics Integration, Chemical Testing, Existing Chemical Review, and New Chemical
Review.
Program Description
The four programs which make up the Toxic Substances Strategies subactivity—
Toxics Integration, Chemical Testing, Existing Chemical Review, and New Chemical
Review—are the core of the Agency's capacity to evaluate the potential effects
of chemicals and regulate harmful chemicals through strategies based on a coordi-
nated approach. These separate program activities conjoin in enabling the Agency
to meet its mandate under TSCA.
Toxics Integration— The major emphasis of the Toxics Integration program
has been changed to reflect the Agency's interest in intermedia chemical problems
and in better communication with other Federal agencies, States, and Regions on
toxic problems. In addition, the Agency will continue to promote a cohesive,
coordinated Agency, interagency, and international approach to solving chemical
problems.
Chemical Testing -- The goal of the Chemical Testing program is to make accu-
rate decisions about the need for additional testfng of high priority chemicals.
These decisions result in the generation of data that will allow EPA to make
reasoned, scientific judgments leading to both regulatory and nonregulatory actions
in its Existing Chemical Review program.
Existing Chemical Review — The goal of the Existing Chemical Review program
is to reduce unreasonable risks to health or the environment caused by chemicals
already in commerce. EPA plans to use a coordinated and flexible inter- and intra-
agency approach to achieve a comprehensive risk reduction. EPA will take maximum
advantage of opportunities to influence industry or user groups to reach negoti-
ated agreements for risk reduction so that risks can be reduced in a more timely
manner.
The Existing Chemical Review program also includes information collection and
risk management activities needed to develop TSCA regulations and otherwise imple-
ment the program. Computer systems are maintained to ensure the confidential
handling of business information, the collection and statistical analysis of health
and environmental monitoring data, and the development and implementation of record-
keeping under TSCA Sections 8 and 12. The Chemical Inventory, which defines the
universe of existing chemicals, includes data on over 60,000 chemicals and is
maintained for both the new and existing chemical programs.
New Chemical Review— EPA's new chemical premanufacture review program re-
flects the general preventive philosophy of TSCA. Its goal is to protect human
health and the environment from unreasonable chemical risks before the chemical
TS-29
-------
enters into commerce. Without imposing undue regulatory burden, EPA will conduct
a program that subjects all new chemicals to a comprehensive premanufacture review
to ensure that risks associated with intended uses are adequately characterized
and, where necessary, controlled. A new function of the New Chemical Review pro-
gram is the review and evaluation of living, genetically engineered organisms to
ensure that society is protected from any adverse health or environmental effects
caused by the use of these substances. Using the "significant new use" authorities
of Section 5(a)(2) or the reporting authorities of Section 8, the New Chemical
Review program closely tracks the commercial development of selected new chemicals
after they have entered commerce.
TOXICS INTEGRATION
1985 Program Request
The Agency requests $2,070,200 supported by 17.8 total workyears for this
program, of which $814,100 is for the Salaries and Expenses appropriation and
$1,256,100 is for the Abatement, Control and Compliance appropriation. The 1985
Salaries and Expenses appropriation is increased by $31,800 to cover increases in
personnel costs. The 1985 request for the Abatement, Control and Compliance appro-
priation is reduced by $682,000 as a result of the transfer of resources to the
Office of Policy, Planning and Evaluation. The emphasis of the Toxics Integration
program has been changed to reflect the Agency's interest in intermedia chemical
problems and the development of cross-media chemical strategies, and in fostering
better communication with States and Regions on toxic substances information
sharing and chemical problems.
In 1985, the Agency will fully implement the new intermedia chemical problem
identification program piloted in 1984. This program will ensure that the Agency
identifies and assigns responsibility for chemical problems in a consistent and
rapid manner. High quality public interaction will be stressed. In a related
effort, the Agency will develop strategies for chemicals of special interest both
to the Toxics Substances program and to the other Agency programs. These strategies
will address cross-media issues and identify the most cost-effective approaches
to total control of the chemical problem.
A second prototype program initiated in 1984 to assist other EPA, Federal, and
State programs in using TSCA information and/or the information gathering and regu-
latory authorities under TSCA will result in a fully implemented information
sharing program in 1985. This program will provide chemical data and technical
know-how to Regions and States to strengthen their capabilities to deal with unique
toxics problems.
In addition to these expanded integration activities, we will continue already
established integration activities. These activities focus on creating and sharing
data bases which contain toxic chemical regulatory and scientific information. The
existence of these data sources encourages consistent decision-making and efficient
use of work already completed. The EPA Chemical Activity Status Report will be
updated and Consumer Product Safety Commission data added. This report, available
through an on-line ADP system, currently includes chemical assessment and regulatory
status information on over 3,800 chemicals of interest to EPA.
Twenty-five more organizations will be added as users of the Chemical
Substances Information Network (CSIN), and one additional organizational network
will be added. CSIN provides easy access to a library of systems through a central
access point. We will update existing Intermedia Priority Pollutant (IPP) docu-
ments and add three new pollutants. These IPP documents contain policy, technical,
and regulatory guidance and are used throughout the Agency. In addition, we
will maintain the Industry File Information System and the Industry Interaction
Matrix. The Industry File Information System, indexed by chemical, includes
information on 83 industry categories which are affected by EPA regulations. The
Industry Interaction Matrix identifies EPA staff involved in toxics-oriented
work in every regulated industry category.
TS-30
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1984 Program
In 1984 the Agency is allocating $2,720,400 supported by 17.8 total workyears
for this program, of which $782,300 is for the Salaries and Expenses appropriation
and $1,938,100 is for extramural purposes under the Abatement, Control and Compli-
ance appropriation.
In 1984, the Agency will begin a pilot program to identify systematically
intermedia chemical problems. In addition, we will focus on fully utilizing
TSCA's broad authorities to address cross-media problems and on coordinated media
approaches. We will pursue a program of intensive interaction with other EPA
programs to make them aware of TSCA's flexible information gathering and control
authorities. This could result in several pilot rulemaking efforts in which TSCA
authorities are used by these offices to solve a problem they are facing.
In another pilot effort, the Agency will begin to explore ways to share
more widely information received as a result of TSCA action under Sections 4 and
8, as well as the technical and scientific knowledge gained over the years of TSCA
implementation. In developing TSCA, Congress clearly recognized the need for
broad public access to data on commercial chemicals and chemical hazards. It
charged EPA with the responsibility for sharing data obtained under the Act with
all interested parties, including Federal, State, and local agencies responsible
for the protection of health and the environment. This sharing of information is
limited only by the the Confidential Business Information protection guaranteed by
TSCA. Significant amounts of data are now available, and through this program
we hope to develop an efficient way to make data widely available to all interested
parties in a manner consistent with the mandates of the Act.
The Chemical Activity Status Report will be maintained and used to perform
analyses to identify duplicative efforts on chemicals and evaluate the Agency's
regulatory behavior. Eight of the 22 Intermedia Priority Pollutant (IPP) documents
will be updated in 1984 and three new IPP's developed. We will continue to main-
tain the Extramural Activity Report which is designed to reduce duplicative work
by EPA grantees and contractors; two updates are scheduled for publication in
1984. The Industry File Information System and Industry Interaction Matrix will
be updated. ' ~ ~" ~ ~
Policy studies on such topics as the feasibility of cross-agency sharing of
confidential data and the pervasiveness of problems of intermedia transfer of toxic
pollutants will be completed in 1984. Implementation steps will begin in several
of the subject areas in 1984, and new studies will begin. Candidate subjects in-
clude issuance of a comprehensive EPA "State of the Chemicals" report and developing
a mechanism for EPA (as an Agency) to publicly "close out" its interests in a
chemical.
The principal efforts in the CSIN program are directed toward enhancing the
system to make its management technology more attractive to potential subscribers
and toward adding additional subscribers and data resources. In 1984, plans are to
add four new data and information resources such as HAZARDLINE and the Ford Motor
Company chemical data base, and 50 more user organizations. One organizational
data system will also be added, and current CSIN capabilities will be made available
to this same organization. Finally, in 1984 we will evaluate the results of the
Section 28 State grant programs closed out in 1983 and 1984.
1984 Explanation of Changes from the Amendment
There is no change from the amendment.
TS-31
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1983 Accomplishments
In 1983, the Agency obligated $3,209,400 supported by 30.0 total workyears
for this program, of which $1,390,100 was for the Salaries and Expenses appropria-
tion and $1,819,300 for the Abatement, Control and Compliance appropriation. In
1983 we issued the report on lead contamination in Dallas. This report was the
culmination of a study coordinated by the Chemical Coordination Staff using re-
sources from EPA Region VI, the city of Dallas, and the Centers for Disease Control.
The study provided a new scientific benchmark in terms of the quality and integrity
of its design and provided definitive information on the tenuous relationship
between soil lead contamination and children's blood-lead levels.
In 1983, the State assistance effort focused on establishing an information
clearinghouse and peer exchange opportunities for States, plus assessing States'
information needs for decision-making on toxics and offering support as appropriate.
Under the State assistance program in 1983, profiles of toxics capabilities of 20
States were prepared, and on-site aid was provided. Two grants were awarded
in 1983. One grant resulted in a report prepared by the National Conference of
State Legislators, which described toxic substances control trends-in State legis-
lation. The second grant was awarded to the Association of State and Territorial
Health Officials/Conference of State and Territorial Epidemiologists (ASTHO/CSTE)
to identify problems in conducting environmental epidemiological investigations,
and to sponsor a conference on environmental epidemiology and toxicology for
State-officials. A compendium of environmental epidemiological investigations by
States will be produced.
Also in 1983, we initiated efforts to add new data and information resources,
as well as 50 new organizations to the Chemical Substances Information Network
(CSIN) program. CSIN is designed to serve the data and information management needs
of private and public sector administrators, engineers, and scientists involved
in the development, production, transportation, use, disposal, and regulation of
chemical substances. We have added the following to CSIN: two major commercial
information vendors, Lockheed's Dialog and the Bibliographic Retrieval Service,
and one system specializing in mathematical modeling, the U. S. Coast Guard's
Hazard Assessment Chemical System. _ This expanded the total to seven information
services or over 400 data bases accessible through CSIN. " Over 160 individuals
from 52 private and public organizations were trained to use CSIN during 1983. A
total of 104 organizations and over 400 individuals are now trained in CSIN.
CHEMICAL TESTING
1985 Program Request
The Agency requests $14,498,000 supported by 112.0 total workyears for this
program: $4,696,200 is for the Salaries and Expenses appropriation, and $9,801,800
is for the Abatement, Control and Compliance appropriation. This represents in-
creases of 7.3 total workyears and $493,400 for the Salaries and Expenses appro-
priation and $1,440,100 in extramural dollars under the Abatement, Control and
Compliance appropriation to finalize .testing actions proposed in previous years.
The increase also expands the test data audit program to keep pace with the in-
creases in test studies now underway.
In 1985, the Agency will continue to place primary emphasis on responding to
the Interagency Testing Committee's (ITC's) most recent chemical designations within
the required 12-month period. The Agency's response to the 13th and 14th ITC
lists, which we expect to include a total of nine chemicals, will be published in
November, 1984 and May, 1985, respectively. EPA will receive and initiate data
development activities for chemicals designated on the 15th and 16th ITC lists.
During the data development phase, EPA will contact chemical manufacturers and
processors, public interest groups, and other parties potentially affected by the
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ITC's recommendations. An extensive effort will then be mounted to gather informa-
tion necessary for the analysis and evaluation of the ITC recommendations, leading
to decisions on the need for testing. The Agency will continue its commitment to
obtain data as quickly as possible, using negotiated agreements when a mutually
acceptable agreement can be reached with industry to perform the required testing.
EPA will always pursue formal rulemaking when necessary.
In the past three years the Agency has concentrated efforts on clearing the
backlog of chemicals on the schedule established by court order and on meeting the
statutory deadlines for new ITC designations. The backlog was eliminated in 1984.
In order to meet these deadlines, testing decisions were issued as proposals. In
1985, EPA will concentrate on finalizing past testing actions and put into place a
process for finalizing future testing actions more quickly.
The Agency will continue test data development activities on chemical cate-
gories identified through the new and existing chemicals programs. Although this
work was started in 1984, the first testing actions resulting from this non-ITC
component of the program will occur in 1985. Testing on those chemicals will
provide the Agency with data necessary to reach a regulatory decision.
In 1985 EPA expects to receive and process 100 applications for exemption from
testing to avoid duplicative efforts when other persons are already performing the
tests. TSCA requires the Administrator to order those persons who have been
granted exemptions from test data submission requirements, but have failed to
reach agreement on reimbursement, to provide fair and equitable reimbursement to
those persons who have previously provided test data on an equivalent chemical
substance or mixture for which the exemption is being sought.
A critical level of test guideline development work will continue in 1985.
This work will focus on chronic health screening tests and higher tier environmen-
tal tests. New guidelines will be coordinated within EPA, with other government
agencies, and with the international community to ensure harmonization with other
testing procedures. EPA will perform the required annual review of all published
test guidelines to ensure their adequacy. This level of effort will vary depend-
ing on the level of public comment and advances made in testing methodologies.
Another critical component of the 1985 Chemical Testing program is the data
audit program. The objective of the data audit program is to ensure that all data
produced, whether a negotiated agreement or a test rule, are adequate for regula-
tory purposes. The validity of these test data will be confirmed through audits
of test studies to ensure testing is conducted pursuant to specified testing
protocols, TSCA/FIFRA testing procedures, and good laboratory practices. EPA will
expand its test data audit program to keep pace with increases in the number of
tests being performed. In addition, we will refine our health and environmental
data audit procedures and begin to develop procedures covering biological testing
and exposure monitoring. These are areas where EPA is just beginning to impose
testing requirements. Audit procedures enable EPA to conduct thorough and consis-
tent data audits on a greater number of studies and further minimize the potential
for invalid data being generated.
EPA will continue to participate in international information exchange pro-
grams. The most visible international effort will be the Agency's participation
in the Organization for Economic Cooperation and Development (OECD). The OECD
Switchboard project, piloted in 1984, will be evaluated and fully implemented.
Member countries need information on particular chemicals expeditiously and at
minimal cost. Unpublished data of importance to the assessment of these chemicals
may be in the possession of manufacturers, governments, and academia. The Switch-
board project establishes an international referral system to facilitate access by
member countries to unpublished information held in other member countries. EPA
chairs the Switchboard project and will provide scientific and information manage-
ment expertise to facilitate full-scale implementation of the project.
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EPA will also develop bilateral and multilateral agreements between OECD
member countries involved in testing programs. These agreements will establish
laboratory and data audit requirements for all testing performed by these countries,
even if the data will be submitted to another country. This will facilitate
acceptance of data and also ensure that the OECD good laboratory practice compli-
ance scheme is implemented.
1984 Program
In 1984, the Agency is allocating $12,564,500 supported by 104.7 total work-
years to this program. Of this total $4,202,800 is for the Salaries and Expenses
appropriation and $8,361,700 is for the Abatement, Control and Compliance appro-
priation. EPA completed action on the backlog of ITC designations prior to the
court-ordered deadline of December 31, 1983. Testing decisions on the llth and
12th lists will be issued in November 1983 and in May 1984 and data development
will begin on the 13th and 14th ITC lists. The 13th list was received in November
1983 and designated four chemicals for testing consideration by EPA. As the back-
log is completed, the Agency will begin to finalize actions taken in past years.
and begin data development on three to four chemicals identified through the TSCA
new and existing chemical program reviews. Testing on these EPA-identified chemi-
cals will provide information needed to reach a regulatory decision.
The Agency will maintain a critical level of guideline development work in
1984 and will publish seven new guidelines. These new guidelines will cover
environmental effects and chemical fate tests. EPA will conduct an annual review
and update of published guidelines as required by TSCA and will republish any guide-
lines which require major revision. One significant guideline update will address
the controversial LD50 (acute lethality) test, which will be updated to reduce on
average the number of animals used in the test. In addition, EPA has published a
rule specifying good laboratory practices that must be observed by laboratories
conducting tests in compliance with TSCA. The work on this rule was completed in
1983; it was published on November 28, 1983.
A comprehensive test data audit program will be a high priority in 1984 as
the number of tests being conducted as a result of TSCA actions will continue to
increase. The Agency is committed to ensuring that data produced by these studies
are of high quality.
1984 Explanation of Changes from the Amendment
There is no change from the amendment.
1983 Accomplishments
In 1983, the Agency obligated $12,422,600 supported by 92.0 total workyears,
of which $3,959,200 was for the Salaries and Expenses appropriation and $8,463,400
was for the Abatement, Control and Compliance appropriation. The Agency responded
to a total of 23 ITC designations in 1983; 16 were backlog designations and seven
were designations from the 9th and 10th ITC lists. Both the December 1982 court-
imposed schedule on the backlog chemicals and the statutory timeframe on the 9th
and 10th lists were met. The Agency published a final data reimbursement rule
pursuant to Section 4(c)(3)(A) of TSCA to ensure fair distribution among chemical
manufacturers of costs associated with performing required testing under Section
4.
The Agency published six new guidelines for conducting basic health and
environmental effects and environmental fate testing. In addition, EPA performed
the required annual review and update of published test guidelines to ensure that
they were adequate. As a result EPA revised 40 of the 80 guidelines published in
1982 after determining that technical areas of the guidelines needed updating.
All but one of the revisions was minor.
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This was the first year in which the Agency saw the results of its negotiated
testing program under Section 4 of TSCA. In 1983, the Agency received nearly 200
test studies performed on chemicals subject to past testing actions under these
negotiated agreements. These data are a key component in the risk identification
activities carried out under the TSCA Existing Chemical Review program and would
not yet be available if it were not for the Agency's negotiated testing approach.
EXISTING CHEMICAL REVIEW
1985 Program Request
The Agency requests a total of $13,709,600 supported by 125.0 total workyears
for this program, of which $5,824,500 is for the Salaries and Expenses appropria-
tion and $7,885,100 is for the Abatement, Control and Compliance appropriation.
This represents an increase of 22.0 total workyears and increases under the
Salaries and Expenses and Abatement, Control and Compliance appropriations of
$1,214,800 and $1,806,300 respectively. The increases will allow the Agency to
undertake risk management action, primarily under Section 6, on the eight chemicals
now in some stage of regulatory development and maintain a risk management program
which can continue to deal with identified existing chemicals problems. It will
also allow EPA to keep pace with the amount of test data being produced as a result
of Congressionally mandated testing programs, such as the TSCA Section 4 Program
and the National Toxicology Program (NTP). The 1985 program strikes a balance
between new and existing chemical responsibilities, allowing EPA to respond
appropriately on new chemicals while maintaining our responsibility to environ-
mental quality by controlling or reducing the risks from existing chemicals.
In the last few years, in recognition of the need for assessment of toxic
chemical risks to humans and the environment, the Congress has supported a number
of programs to generate the toxicity data needed for risk assessment. Congress
established the testing program under Section 4 of TSCA for this purpose. Simi-
larly, it has created the NTP and supported testing under other Federal agencies'
programs. This Federal activity has, in turn, prompted industry to do more testing,
sponsored both by individual companies and by industry consortia. These various
programs are now producing data and identifying candidates for risk assessment.
These test results must be analyzed first to put in priority order those chemicals
for which data indicate significant potential risk and then to perform in-depth
risk assessments on those for which controls may be needed.
With 60,000 chemicals currently in commercial use it is important to establish
priorities. TSCA has a series of natural screening mechanisms. Section 8(e)
notices of substantial risk, Section 21 petitions, Section 4 test data, as well as
Section 8 reporting rules all feed data on existing chemicals into the risk identi-
fication process. The new chemicals program is also a screening mechanism in that
new chemical categories are usually minor variants of existing chemicals; i.e.,
chemicals that surface as problems in the new chemical review process often point
to problems with existing chemicals. NTP testing and broad-based monitoring
studies also identify existing chemical problems. These programs identify chemi-
cals which are a high priority for data development or which have adequate hazard
data to support assessment. Once necessary data are available, the Agency must
act quickly to evaluate this information and take action where necessary. These
mechanisms identify 50-60 chemicals per year for evaluation.
The Agency's risk evaluation efforts will continue to focus on specific areas
of concern. Chemicals will proceed through a series of information-gathering stages
designed to enable rational decisions as to whether additional data or regulatory
actions are needed. Chemicals will be dropped from review if no significant risk
is found. All decisions will be documented. Chemical-specific monitoring studies
will be conducted on chemicals when exposure data are needed to support regulatory
decisions. EPA will use the information-gathering authorities of TSCA to require
industry to report additional information on existing chemicals about which there
is concern.
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The major Section 8(a) Preliminary Assessment Rule and Section 8(d) Health
and Safety Study Rule promulgated in previous years will be amended to add chemi-
cals designated for testing by the Interagency Testing Committee (ITC). By amend-
ing these broad information-gathering rules to include chemicals on each new ITC
list, EPA assures a steady flow of information into its existing chemicals program.
The Agency will begin to use Section 8(c) records of alleged adverse reactions as
a significant source of data for the existing chemicals program. Section 8 will
also be used to update production information on a selected segment of existing
chemicals on the TSCA inventory.
In 1985, EPA will be involved in risk management actions on eight existing
chemicals: asbestos, PCBs, MBOCA, MDA, 1-3 butadiene, glycol ethers, cutting
fluids, and to!uenediamines (TDA). Asbestos has been subject to regulatory in-
vestigations for several years. EPA now has adequate data for major rulemaking on
this very hazardous and widely used substance. We plan to issue a final rule on
several asbestos product categories that account for over 50 percent of the asbestos
fiber consumption; we also plan to issue a proposed Section 6 rule imposing a
staged production cap on all remaining uses of asbestos.
EPA also plans to issue final Section 6 rules on two chemicals, 4,4'-methy-
lene Bis (2-Chloraniline), commonly known as MBOCA, and 4,4'-methylenedianiline,
commonly known as MDA. We will begin development of a rule to reduce the risks
posed by glycol ether solvents, with proposal expected in early 1986. EPA will
also propose rules on 1,3-butadiene and on cutting fluids. The Agency will also
issue a final rule on PCBs, addressing the hazards posed by fires evolving from
electrical transformers that contain PCBs. A negotiated rulemaking on toluene-
diamines should be completed this year.
The Agency also is responsible for assisting the industry and the public in
understanding what the rule requires (i.e., the exemption provisions of the PCB,
CFC, and dioxin rules). The 1985 activities in this area will include the re-
view of requests for permits to dispose of PCBs in mobile incinerators or by
other means, as well as review of requests for exemptions to Section 6 rules on
PCBs and CFCs. Participation on the Federal Asbestos Task Force and the provision
of assistance and information on asbestos through the Asbestos Technical Assistance
Program will also continue.
1984 Program
In 1984, the Agency is allocating a total of $10,688,500 supported by 103.0
total workyears to this program. Of this total, $4,609,700 is for the Salaries and
Expenses appropriation and $6,078,800 is for the Abatement, Control and Compliance
appropriation. In 1984, the Agency will maintain the momentum gained in 1983 when
it put in place an integrated existing chemicals risk evaluation and control pro-
gram. The assessment of existing chemicals is a five-phase process designed to
focus on specific effects of concern. In the first phase, EPA uses TSCA's basic
screening mechanisms to choose the chemicals that should be further evaluated.
Approximately 60 chemicals are in one of the evaluation stages (phases 2-4)
at any given time. The risk evaluation phases of the process include charac-
terization of the problem by looking at hazard and exposure information. Risk
reduction analyses focus on switching to substitutes, changing chemical handling
practices, required labeling, and the cost of implementing the various controls.
The final phase is risk management; when TSCA does not provide clear authority we
will work with other EPA offices and Federal agencies for risk reduction actions.
In 1984, the Agency will gather information on existing chemicals of concern
by triggering existing Section 8(a) and 8(d) rules upon receipt of each ITC list.
We will consider the use of Section 8 to update the TSCA inventory, as well as the
need for some broader Section 8(a) rules for chemicals being considered for Section
6 control. We will begin developing these strategies in 1984.
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The Agency will complete rulemaking on PCB issues relating to the Environ-
mental Defense Fund suit on the 50 ppm cutoff for purposes of defining the presence
of PCBs. As a result, EPA will work on four rules in 1984 which deal with PCBs.
The third part of the PCB rule, which addresses uncontrolled uses of PCBs, will
be proposed and finalized by July 1984. In addition, EPA will begin development
of a regulation covering the risks posed by fires evolving from electrical trans-
formers that contain PCBs, finalize the reauthorization of PCBs in research and
development and microscopy, and finalize the PCB exemption rule.
In addition to the work on PCBs, EPA will begin work on Section 6 rules for
asbestos, MBOCA, and MDA. EPA will coordinate its rulemaking activities on
asbestos with other agencies through the Federal Asbestos Task Force. We will
also be analyzing comments recieved on the advance notices for MBOCA and MDA and
begin formulating our regulatory strategies.
The Agency will continue to assist industry and the public in understanding
and responding to existing chemical actions by continuing programs such as the
Asbestos-in-Schools Technical Assistance Program, the Brake Mechanics Program, and
the PCB Disposal Permitting program.
1984 Explanation of Changes from the Amendment
There is no change from the amendment.
1983 Accomplishments
In 1983, the Agency obligated $10,931,700 supported by 114.5 total workyears,
of which $4,782,600 was for the Salaries and Expenses appropriation and $6,149,100
was for the Abatement, Control and Compliance appropriation. The Agency's approach
to existing chemical control changed dramatically in 1983. EPA set up the Existing
Chemicals Task Force with responsibility for developing and puting into place a
project management system for evaluation and decision making on risks from existing
chemicals.
During 1983 the existing chemicals program received and reviewed a substantial
amount of data on existing chemicals. The Section 4 negotiated testing program
resulted in submission of 200 completed test studies by industry. Section 8(a)
and Section 8(d) rules resulted in submission by the chemical industry of over
3,000 studies and reports on existing chemicals. Under the Section 8(e) substan-
tial risk notification program, EPA received 35 initial reports, 59 "for-your-
information" submissions, and 94 supplements related to previous initial reports.
Twenty-six NTP studies were also received and reviewed. Chemical Hazard Identifi-
cation Profile documents (CHIPs) were prepared for 20 of the chemicals.
The screening resulted in over 60 chemical evaluations. Approximately 30
chemicals were targeted for further analyses and decisions in 1984; eight chemicals
were moved into development of Section 5 or Section 8 rules; one chemical, MDA,
was identified as a Section 4(f) candidate; and five chemicals were moved into
regulatory development under Section 6. About 20 chemicals dropped from review.
In 1983, we amended the Section 8(a) Preliminary Assessment Reporting rule to
add chemicals from the 6th through the 9th and the llth and 12th ITC lists (the
10th ITC list was included as part of the initial Section 8(a) rule). We also
amended the Section 8(d) Health and Safety rule to include chemicals from the 6th
through 12th lists. EPA implemented another major TSCA information authority by
promulgating the Section 8(c) rule requiring that records be kept for 30 years on
allegations of significant adverse reactions.
During 1983 four final rules regarding PCBs were promulgated. The first rule
set numerical cutoffs (parts per million) for purposes of defining the absence of
PCBs in releases from closed and controlled waste processes. This rule also adds
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additional disposal mechanisms to the list of acceptable mechanisms for the dis-
posal of controlled waste containing PCBs up to 50 parts per million. The second
rule pertained to PCS concentration in railroad transformers; the third, to
approval of disposal facilities; and the fourth to testing methods. Other risk
management actions include Advance Notices of Proposed Rulemaking on MDA and MBOCA.
EPA also proposed its first followup actions on existing chemicals. Chlor-
inated napthalenes (CNs) and chlorinated terphenyls (CTs) were designated for
Section 4 testing consideration by the ITC. However, the use of CNs has declined
to low levels, and CTs are no longer used in the United States. As a result, EPA
concluded that test rules were not justified at this point. To ensure against
renewed production or expansion of current uses without adequate review, the Agency
will track these chemicals through followup rules. A Section 8(a) rule was pro-
posed to require manufacturers or importers of CTs to report certain information
on existing or proposed production; a proposed rule under Section 5(a}(2) was
published. Under this rule any domestic manufacture of CN or any cumulative
manufacture or import over 100,000 pounds a year is considered a "significant new
use" and subject to EPA review under Section 5.
NEW CHEMICAL REVIEW i
1985 Program Request
The Agency requests a total of $15,140,400 supported by 216.6 total workyears
for this program, of which $9,002,700 is for the Salaries and Expenses appropriation
and $6,137,700 is for the Abatement, Control and Compliance appropriation. This
represents an increase of 8.8 total workyears and increases of $729,800 in Salaries
and Expenses, and $753,000 in Abatement, Control and Compliance. These increases
will enable EPA to initiate a program addressing the coverage under TSCA of genet-
ically engineered materials. Commercial use of biotechnical substances is not
covered under any other Federal regulation, and significant risk may be associated
with some of the uses of these substances, particularly as a result of their release
into the environment.
In 1985, the review of new chemicals continue?" to~be a high Agency priority.
All new chemicals will be subjected to a thorough review to ensure that health and
environmental risks are adequately controlled. This includes premanufacture no-
tices, test market exemption applications, and, if applicable, Section 5(h)(4)
exemption notices. Conservative estimates suggest that about 1,650 new chemicals
will be submitted for review in 1985; this reflects an increase over past years.
About 180 chemicals will raise sufficient health or environmental concerns to
require a detailed review to characterize their risk; about 120 new chemicals will
require some control action by the Agency. Agency control actions include volun-
tary actions such as testing, exposure controls, or withdrawal of the PMN by the
manufacturer, the use of Section 5(e) consent orders which allow some commercial-
ization with tight controls while data are developed, a ban on chemical production
pending data development, or the development of controlled use regulations on
the chemical.
In addition, EPA expects to receive 80 test marketing exemption (TME)
applications. These applications are reviewed to determine that the substance
will not present an unreasonable risk to human health or the environment under the
test marketing conditions. The burden is on the exemption applicant to provide
sufficient information to make the "no unreasonable risk" finding or EPA will deny
the request. In the past, EPA has denied or modified approximately 10 percent of
incoming TMEs.
Since the number of new chemicals being introduced and requiring some EPA
control continues to grow, we must look for ways to expedite our reviews so that
other aspects of the program, such as followup, PMN rule clarification, and bio-
technology, also receive adequate attention. One of the major deterrents to ex-
peditious review is lack of adequate information with the premanufacture notice.
In 1985, EPA will look for ways to address this problem. One of the approaches
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being considered is pre-notice communication with past submitters to discuss their
new product line and to clarify EPA's PMN data requirements. This should result
in more adequate PMN data submissions and enable more PMN reviews. Eventually,
this approach is also expected to reduce the number of detailed reviews and control
actions.
We will continue our case-by-case followup program using the significant new
use authority of Section 5(a)(2) and the Section 8(a) information gathering author-
ity. We will issue "significant new use" rules for new chemicals on which a
Section 5(e) order is issued. This will impose on all manufacturers and processors
the same restrictions which have been imposed on the premanufacture notice submitter.
We also plan to finalize a general Section 8(a) reporting rule that would require
companies to submit reports on new chemicals when they reach a given annual pro-
duction volume. Additional options will be examined for obtaining more data as
chemicals prove to be commercially viable. This broad approach to followup will
provide added protection to public health and the environment.
EPA will develop a rule under Section 5(b)(4) of TSCA, which authorizes EPA to
create a list of chemical substances or categories of chemicals that have been de-
termined to present (or may present) unreasonable risks during manufacture, process-
ing, distribution in commerce, use, or disposal. If a PMN is submitted for a
chemical category which has been included on the "risk list," this rule would
require the PMN submitter to furnish data which shows that the substance does not
present an unreasonable risk.
In 1985, EPA will explore ways to more effectively communicate to industry and
the public the technical rationale for its decisions on new chemicals. Along
these lines, the Agency will begin to prepare advisory circulars on new chemicals.
These advisories will summarize data requirements or controls needed on specific
categories of new chemicals, describe the rationale for specific decisions on
controversial cases, and announce decisions or legal interpretations related to
new chemical reviews. To the extent that EPA can articulate its decisions and
concerns, it can provide the chemical industry with important insight into how the
Agency has dealt with specific issues and promote greater public oversight of new
chemical reviews.
In 1985, we will be evaluating living, genetically engineered organisms
(biotechnology) under Section 5 of TSCA. Biotechnology has until very recently
been a laboratory-scale phenomenon; however, commercial uses potentially subject
to TSCA regulation are now under development. Significant risk may be associated
with some of the uses of these organisms, particularly as a result of their release
into the environment.
We will proceed to develop appropriate risk assessment techniques and testing
protocols applicable to reviewing these biotechnical materials within the statutory
90-day period. However, we must develop the appropriate techniques and models
for analyzing the hazards of these unique substances, change our current modeling
approach from physical-chemical properties to predicting fate in the environment,
and deal with the unique cost/benefit issues which these substances will raise.
As with the PMN review process, the process for reviewing biotechnical materials
will be refined as we gain experience and establish operating policies for ad-
dressing the risks posed by these materials.
1984 Program
In 1984 the Agency is allocating a total of $13,657,600 supported by 207.8
total workyears to this program. Of this $8,272,900 is for the Salaries and
Expenses appropriation and $5,384,700 is for the Abatement, Control and Compliance
appropriation. With these resources, the Agency will maintain aggressive new
chemical review and followup programs. We will act quickly to identify potential
problems or data gaps using the authority of Section 5(e) flexibly to induce data
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development and to control exposure. In 1984, we anticipate receiving 1,450
premanufacture notices, of which about 100 will require some form of Agency con-
trol, either voluntary or formal. We will review 80 test market exemption requests
submitted to the Agency pursuant to Section 5(h)(l), either granting or denying
the request within the 45 days mandated by TSCA. As in the past the applicant
must provide sufficient information to the Agency to support a finding of no un-
reasonable risk, or the application will be denied.
EPA will continue to implement its strategy to track new chemicals after
commercialization, using both the Section 5(a)(2) significant new use rule and
Section 8(a) provisions of TSCA. EPA will track new uses of chemicals with toxi-
city or exposure concerns, as well as new chemicals which are subject to consent
or formal Section 5(e) orders. This extends the conditions of the Section 5(e)
order to all manufacturers or processors of these chemicals, which otherwise could
be marketed without restriction. We plan to supplement our case-by-case followup
program with a broader approach by developing a general Section 8(a) reporting
rule. This rule, to be proposed this year and finalized in 1985, will require
companies to submit reports when production volume reaches a given annual rate.
EPA will continue to work toward promulgation of the three pending Section
5(h)(4) exemption rules proposed in 1983. These broad-based exemption categories
include site-limited intermediates (chemicals that react with other chemicals at
their plant site), chemicals that are produced in small amounts (i.e., less than
10,000 kg/yr.), and certain polymers. Once these rules are promulgated, about 36
percent of the new chemical submissions will be eligible for a shortened review
under one of these rules.
1984 Explanation of Changes from the Amendment
There is no change from the amendment.
1983 Accomplishments
In 1983, the Agency obligated $13,532,200 supported by 201.2 total workyears
for this program, of which $7,664,600 was for the Salaries and Expenses appropria-
tion and $5,867,600 was for the Abatement, Control and Compliance appropriation.
EPA has taken major steps over the last year toward fully implementing the new
chemicals program. The final PMN rule, together with a mandatory notice form, was
issued in 1983. Most provisions of the rule became effective; however, provisions
which cover exemptions for research and development activities, the definition
of possession and control, and the data requirements on related chemicals were
stayed by EPA pending further review. With its experience in new chemical review
and regulation, EPA can now act more quickly to identify potential problems or
gaps in data. This stems partly from the refinement of the program but also
reflects better EPA data bases and more communication with submitters.
Since the beginning of the program, EPA has received more than 3,000 PMNs.
During that time EPA has issued 14 Section 5(e) orders banning or controlling
exposure to 27 chemicals pending the development of additional data (ten of these
orders covering 16 chemicals were issued in 1983), and required testing on 53
substances in light of EPA concerns. Another 24 notices were withdrawn in light
of EPA concerns. In 1983, EPA acted on 81 test market exemption applications of
which 74 were granted, two denied, and five were withdrawn in anticipation of EPA
action.
In one major new chemical action that year, EPA reviewed a notice submitted
by Union Oil Company on a wide range of new synthetic fuels to be derived from oil
shale in the nation's first oil shale project. EPA and Union Oil entered into a
Section 5(e) consent agreement that requires controls on workplace exposure and
environmental release and limits the overall production of shale oil until long-
term toxicity testing is completed and reviewed.
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Since the beginning of the PMN review program the Agency had identified ap-
proximately 275 chemicals as requiring followup. This backlog of chemicals was
reviewed to determine whether toxicity and exposure warranted followup action.
The Agency also prepared documentation explaining why no action was taken on
chemicals for which it found no regulatory action was necessary. EPA also adopted
a practice of issing significant new use rules, called SNURs, in conjunction with
Section 5(e) orders, and proposed three significant new use rules covering five
chemicals. One rule covers two chemicals which had been subject to Section 5(e)
orders, and two rules cover three chemicals which were identified from the followup
backlog. Another six rules (covering 12 chemicals) were developed with publication
expected in early 1984.
EPA evaluated comments received from the public on its proposal to exempt
broad categories of new chemicals from full PMN review. Three Section 5(h)(4)
rules were proposed in 1983 covering site-limited intermediates, low volume chemi-
cals, and certain polymers. EPA developed final rules based on comments received.
TS-41
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ENVIRONMENTAL PROTECTION AGENCY
1985 Budget Estimate
Table of Contents
PAGE
TOXIC SUBSTANCES TS-1
ENFORCEMENT
Toxic Substances Enforcement TS-43
Toxic Substances Enforcement TS-45
Toxic Substances Enforcement Grants TS-48
TS-42