EPA FIVE-YEAR NOISE EFFECTS
            RESEARCH PLAN
                   DRAFT
EJBD
ARCHIVE
EPA
950-
D-
79-
001
NOVEMBER 19, 1979

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SUMMARY:  HEALTH CONSEQUENCES OF CHRONICALLY NOISE-DISTURBED SLEEP
          EPA GRANT TO:   STANFORD UNIVERSITY
I.   Objectives
The objectives of the proposed work are:   (1)  to  determine by a  number  of
simultaneous physiological  and other measures  in  the field, the  effects of
noise on sleep and subsequent daytime functioning,  and (2) to test  for
recuperation or improvement in these parameters as  a result of quiet, un-
disturbed sleep in the laboratory.

Phase 1  will monitor cardiovascular measures,  respiration, temperature, and
physical activity, over a 24-hour period,  by use  of an ambulatory monitor
which will  be worn throughout Phase 1.

For the first few days, these parameters will  be  monitored during regular work
on the job.  The last two days, subjects will  report to the laboratory, where
daytime measures will  include the Multiple Sleep  Latency Test (MSLT)  (an
objective measure of sleepiness), the Stanford Sleepiness  Scale  and a Mood
Scale.  Performance tests will  also be  conducted.   Nighttime measures,  all
taken in the home, will include standard sleep monitoring, and three  acoustic
monitors, the data to be transmitted by telephone.

In Phase II, subjects will  sleep in a quiet laboratory, where sleep measures
will  be the same as those in Phase  I.   Phase II again monitors subjects around-
the-clock using the ambulatory microprocessor.  Subjects will  go to work as
usual for several  days, and then report to the laboratory for MSLTs and other
tests on succeeding days.

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Subjects will be males between 40 and 50 years old who sleep with bed
partners (who will also be instrumented for limited nighttime monitoring),
and whose jobs expose them to relatively low levels of noise.  Ten subjects
will be chosen from a high-impact neighborhood exposed to aircraft noise.
Ten controls will be matched on a number of relevant parameters, but will
live in a quiet neighborhood (the controls may not participate in Phase II).

II.   Relationship of this Project to Program's Mission

This study is an integral step in the development of criteria for health
effects due to chronic sleep disturbance by noise, as detailed in the EPA
Five-Year Noise Effects Research Plan (Initiative II:  Health Consequences
of Noise-Disturbed Sleep).  The study involves cardiovascular and respiratory
measures monitored on a 24-hour basis in the field and laboratory and will
thus also contribute to the nonauditory noise effects program as well.

The following protocol is subject to change in consultation with EPA.

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SUMMARIZED PROTOCOL FOR STUDY OF HEALTH CONSEQUENCES  OF NOISE-DISTURBED SLEEP

                                  PHASE I


ONE WEEK BEFORE NIGHT ONE -  START SLEEP/WAKE DIARY

TWO DAYS BEFORE NIGHT ONE -  START AMBULATORY MONITOR

NIGHT ONE -

          TEST SUBJECT - TELEPHONIC SLEEP RECORDING

                       - ACOUSTIC RECORDING

                       - PHYSIOLOGICAL RECORDINGS FROM AMBULATORY  MONITOR

          BED PARTNER  - OVERNIGHT AMBULATORY MONITOR

                       - ACOUSTIC RECORDING

DAYS TWO AND THREE:

        - GO TO WORK AS-USUAL WITH AMBULATORY MONITOR.

NIGHTS TWO AND THREE:

        - AS FOR NIGHT ONE

DAY FOUR:

        - SUBJECT TRAVELS TO SLEEP LABORATORY AND UNDERGOES MULTIPLE SLEEP
          LATENCY TESTS   (MSLT) AND PERFORMANCE TESTS

NIGHT FOUR:

        - AS FOR NIGHT ONE.

DAY FIVE:

        - AS FOR DAY FOUR


                                 PHASE II

This phase of the project will involve the test subjects  but may not involve the
control subjects.  The  procedures will be the same as for PHASE ONE except that:

     The nocturnal recordings will take place in the sleep recording laboratory
and will occur in a normal  (low noise) environment.

     The nocturnal recordings will run for five successive nights.  Subjects
will work as usual during the first three days, and as before, attend the labora-
tory for multiple sleep  latency tests  during the last two days of the procedure.

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                  Headquarters and Chemical Libraries
                       EPA West Bldg Room 3340
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                      THE EPA FIVE-YEAR NOISE EFFECTS

                               RESEARCH PLAN
                                 DRAFT
                     Repository Material
                    Permanent Collection
                         DO NOT QUOTE OR CITE
                         November 19, 1979

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                EPA NOISE EFFECTS RESEARCH PLAN


                       Table of Contents


Contents                                                          Paee

1.    Introduction                                                1~ 1

      1.1     Legislative and Programmatic Requirements           1- 1
              for Research

      1.2     Goals of the EPA Research Program                   1- 4

      1.3     Reader's Guide to the Research Plan                 1- 8

2.    Overall Priorities for the EPA Noise Effects Research  Plan   2- 1

      2.1     Overall Results of Priority Analysis                2- 2

      2.2     Level of Emphasis A (Highest Level)                 2- 3

              2.2.1    Nonauditory Physiologic Effects            2- 3

      2.3     Level of Emphasis B                                 2-6

              2.3.1    Sleep Disturbance                          2- 6

              2.3.2    Individual and Community Response          2- 8

      2.4     Level of Emphasis C                                 2-12

              2.4.1    Noise-Induced Hearing Loss                 2-12

              2.4.2    Behavioral, Social and Performance         2-15
                       Effects

      2.5     Level of Emphasis D                                 2-18

              2.5.1    Communication Interference                 2-18

      2.6     Level of Emphasis E (Lowest Level)                  2-19

              2.6.1    Effects of Noise on Wildlife               2-19

3.    EPA's Research Plan in Detail (Introduction)                3- 1

      3.1     Definition of Long-range Objective                  3- 1

      3.2     Definition of Short-term Objectives and             3- 1
              Base Year

      3.3     Definition of Research Initiatives                  3- 2


                             ii

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                       Table of Contents (Cont'd)
Contents                                                          Page
      3.4     Concept of Evolution in Research                     3-2
              (the Research Continuum)

      3.5     Contents of the Research Flan for Each Category      3-6

      3.6     Establishing Fiscal Year Funding Levels              3-6

      3.7     Assumptions                                          3—3


 *4.  Research Plan for Nonauditory Physiologic Effects            4-1

 *5.  Research Plan for Sleep Disturbance                          5-1

 *6.  Research Plan for Individual and Community Response          6-1

 *7.  Research Plan for Noise-Induced Hearing Loss                 7-1

 *8.  Research Plan for Behavioral, Social and Performance         8-1
      Effects

 *9.  Research Plan for Communication Interference                 9-1

*10.  Research Plan for Effects of Noise on Wildlife and          10-1
      Other Animals

*11.  Research Plan for Exposure Characterization                 11-1

12.   Summary

      12.1    Integrated Research Initiatives,  by Fiscal Year     12-1

      12.2    Integrated Schedule of Expected Results FY 81-85   In progress

      12.3    Integrated Schedule of Evaluation/Decision
              Points During the Plan Period                     In progress

      12.4    Relationships to EPA Five-Year Noise Plan         In progress

      12.5    Looking Ahead:   After the First Five Years        In progress
      See the detailed Table of Contents  for  each  of  the  Research  Plans.
      These can be found at the beginning of  Chapters 4  through  11.
                                   iii

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                         LIST OF TABLES
Table                         Title
  3-1            Identified Research Initiatives                     3-3

  3-2            Research Continuum  in  the Development
                 and Requirement of  Health Effects
                 Criteria                                           3-5

  3-3            Items Included in the Plan for Each
                 Research Category                                  3-7

  4-1            Position on the Research Continuum -
                 Nonauditory Physiologic Effects                    4-8

  4-2             Estimated Levels of Co-Support
                 From Other Agencies in the Non-
                 auditory Physiologic Effects
                 Research Category                                  $-11
  5-1             Position on the Research Continuum -
                 Sleep Disturbance                                 5-7

  6-1             Position on the Research Continuum -
                 Individual  and  Community Response                  6-5

  7-1             Position on the Research Continuum -
                 Noise-Induced Hearing Loss                         7-8

  8-1             Position on the Research Continuum -
                 Behavioral,  Social and Performance
                 Effects                                            8-8

 9-1             Position on the Research Continuum -
                 Communication Interference                         9-7


10-1             Position on the Research Continuum -
                 Wildlife Effects                                10-5

12-1             Funding  of  Plan, by  Fiscal Year                  12-6
                                     iv

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                         LIST OF FIGURES
 Figure                       Title
 4-1              Timing and EPA Funding for
                 Nonauditory Physiologic Effects
                 Research
 4-2             Funding for Nonauditory  Physiologic
                 Research,  With  and  Without  Co-Support              4-29


 5-1             Timing and EPA  Funding for                         5-13
                 Sleep Disturbance Research

 6-1             Timing and EPA  Funding for                         6-16
                 Individual and  Community
                 Response Research

 7-1             Timing and EPA  Funding for                         7-16
                 Noise-Induced Hearing Loss
                 Research

 8-1             Timing and EPA  Funding for                         8-12
                 Behavioral,  Social  and
                 Performance  Research

12-1             Aggregate  Funding for All
                 Research Categories,  by
                 Fiscal Year                                      12-3

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                             1.   INTRODUCTION



1.1          Legislative and Programmatic Requirements  for Research

             The Environmental Protection Agency  (EPA)  has the  respon-

sibility to protect people from excessive noise that may  jeopardize

their health and welfare.  The Noise Control Act  of 1972, as amended

by the Quiet Communities Act of 1978, recognizes  that specific  infor-

mation concerning the effects of noise on people  is critically  needed

in order that EPA may efficiently carry out its mission to coordinate

activities in noise control, to authorize the establishment of  Federal

noise emission standards for products distributed in commerce,  and to

provide information to the public reflecting the hazardous effects of

 noise, and noise levels associated with such effects.

             To that end, the Act (as amended) requires EPA to:

             "Conduct or finance research...including but not
             limited to - investigation of the psychological and
             physiological effects of noise...and determination
             of dose-response relationships suitable for  use in
             decision making, with special emphasis on  the non-
             auditory effects of noise."  (Sect.  14. (6)).

These requirements represent a substantial expansion of noise-effects

research responsibilities from those originally set forth in the Noise

Control Act of 1972.   Subsequently EPA is required to develop a health

effects research strategy delineating (a) EPA's research  objectives over a

five-year period (Fiscal Years 1981-1985),  (b) the relative priorities

among various categories of research activities, and (c)  a schedule or

timetable of research activities to attain these research objectives.


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             In addition to the specific legislative requirements cited




above, research with respect to the effects of noise on public health  is




required to support the various components of the EPA noise control




program.  On that account, a health effects research strategy must be




responsive to the health-related needs inherent in the EPA noise program




strategy.  Elements of concern to the health effects research strategy




include:  the development and enforcement of noise emission regulations,




the provision of technical assistance to State and local noise control




efforts, the dissemination of information to the public on the health




effects of noise, research and demonstration of advanced noise control




technology, and the coordination of noise control activities and health




effects research among Federal agencies.




             The quantification of the health-related effects of noise




is necessary in the development of all noise related legislation




at the Federal, State and local governmental levels, since the purpose of




such legislation is to protect public health.  Citizens and public officials




alike need to be adequately informed as to the health consequences of




noise exposure in order to make rational, efficient, and cost-effective




social decisions to secure a healthy environment.  Research is fundamental




to:  1) establishing information on the incidence and severity of health-




related effects such as hearing loss, nonauditory physiologic effects, and




sleep disturbance;  2) developing human response criteria to quantify  the




effects and health consequences of noise; and 3) ascertaining a cause-




effect relationship due to specific source environments.
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             Other Federal agencies  such  as  the  Department of

Transportation, the Department  of Defense, and  the  National Aeronautics

and Space Administration presently support their noise  control

activities with research programs vhich  investigate both the direct and

indirect health effects caused  by exposures  to  different types of noise

sources or noise containing  specific acoustical  characteristics.   In

many instances, the human response criteria  developed by one agency are

incorporated into those standards and  policies  of another agency.

Ultimately there should be one  set of  health-related criteria used by all

agencies.  Agencies would then  develop noise-related policy under their

respective authorities using  these criteria  based upon  specific health

implications as well as social,  legal, and economic considerations.   How-

ever, the foundation of noise-related  policy must rest  on an understanding

of basic health effects.

             EPA has had extensive experience in monitoring and coordina-

ting the noise effects research  of all Federal agencies  over the  past few

years.  In 1977, EPA reconvened  a panel of representatives from Federal

agencies vfaich conduct noise  research  to  review  the status of all Federal

research activities with respect to  the health effects  of noise,  and to

recommend areas where further research was needed.   The  Panel found  that

over 19 agencies,  or major organizations  within  agencies,  conducted  health

effects research at a total  funding  level of approximately six million

dollars annually.*  EPA conducted relatively little of  this  research ($190K
*  Federal Noise Research in Noise Effects,  (EPA Report 550/9-79-102)
   February 1978.

                                1-3

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to $349K in Fiscal Years 1975-1977).  (Updated  research  project  and  funding

sumnaries from all Federal agencies during  the  Fiscal  Years  1978 to  1980

are now being collected.)  While each agency's  noise-related research

might adequately support its own limited mission  and goal,  the Panel found

that taken in its totality, the overall pattern of  research  on noise effects

contained numerous gaps in the health effects data  base  and  limitations

in existing human response criteria.  Although  some health  effects criteria

were already being applied, other potentially severe health  consequences

of environmental and occupational noise exposures were not  being adequately

addressed.  The Panel report recommended that steps be taken to  fill these

gaps.  To that end, EPA and other Federal  agencies  have  initiated several

research projects (described in Chapters 4-12).   The Panel  report has  also

been instrumental in the design of  the present  health  effects  research

strategy* and the specification of  numerous research priorities.



1.2          Goals of the EPA Research Program

             The overall goal of an EPA  research  program is  stated below.

This goal is based on:  1) the fundamental  importance  of health  effects

information in support of noise control  legislation and  policies;

2) knowledge of the status of existing health and welfare criteria and

data.

Overall goal:    To improve the noise related health and welfare
                 data base, refine  existing criteria,  and develop
                 quantified dose-response  criteria  where they are
                 lacking.
*  This strategy  will be  referred  to  as  the  Research Plan.

                                  1-4

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             Only through the development of quantified  dose-response  criteria




can a thorough understanding of the health  implications  of  noise  be  obtained




and health benefits be properly ascribed to all noise  control  actions,  whether




taken on Federal, State or local levels.




             The overall EPA research program goal has been broken down into




a number of specific objectives for various identified categories of noise-




effects research.  The research categories  used are  similar to those cited  in




the previously discussed EPA Panel Report.  Further, EPA Research Initiatives




have been proposed in the present strategy  to meet these specific objectives.




Each Initiative will be expressed in one or more  research projects,  evolving



in a time-phased manner, Co answer major research questions in a  defined area.




In determining the content of the Research  Initiatives,  EPA will  consider the




specific programmatic applications of any research finding  to  particular




noise control activities undertaken by either EPA, other Federal  agencies,




State and local communities, or the private sector.




             EPA has a responsibility to make the latest research results




available to both the general public and to State and  local noise control




officials in order to collectively meet our nation's noise  control needs.




For example, the public is more likely to make informed  decisions regarding




the purchase of quieter consumer products or even the  selection of a location




to live when they have more detailed information on  the  adverse health




effects of noise.  Citizens need more information to make decisions  regarding




their own personal noise exposures.  Public officials  need  more information




to set into motion the necessary programs to improve the quality  of  the noise




environment.  State and local officials need better health  criteria  to




                                 1-5

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support and justify their noise regulations and policies.  They must have

the necessary health-related information to determine what degree of noise

control is needed and should be considered in the many routine administrative

actions that touch each of our lives every day such as:  building codes;

comprehensive land use planning; traffic management; municipal purchasing

decisions; zoning variances; enforcement of laws; vehicle inspections.

    Accordingly, the following categories of noise effects research

have been specified.  There are seven major categories of noise-related health

effects which either presently serve as the foundation for existing criteria

or have the potential for being incorporated into specific noise effects

criteria provided that the necessary research is undertaken and dose-response

relationships established.  These categories of research are presented with

their accompanying research objectives. They are not presented in any order

of priority.
1.  Wonauditory Physiological Effects — to determine and quantify the
    nonauditory effects on bodily systems and on general health, with
    special emphasis on hypertension and other cardiovascular effects.

2.  Noise-Induced Hearing Loss—to determine the extent of the problem,
    causative factors, and associated effects.

3.  Individual and Community Response—to determine and quantify subjective
    reactions of individuals and communities to different environments and
    sources, investigating mediating factors.

4.  Sleep Disburbance—to determine and quantify effects of noise on sleep,
    and its implications for general health and performance.

5.  Communication Interference—to determine and quantify the effects of
    noise on communications and its developmental, social and other
    implications.
                                 1-6

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6.  Behavioral, Social and Performance—to determine and quantify the
    effects of noise on social behavior, mental health, and human
    performance.

7.  Wildlife—to determine and quantify the effects of noise on wildlife
    and domestic animals.

             It should be pointed out that these are long-term objectives.

Some information is available as a first step in meeting a few of these

objectives.  Accordingly, the specific Research Initiatives which EPA is

now proposing to meet the identified objectives in each category will focus

on the most important gaps and deficiencies in our understanding.

             There are two additional areas of noise related research

that have not been identified:  exposure characterization and vibration.

The objective of exposure characterization is to determine patterns of

noise exposure, typical noise doses attributable to different sources

and/or environments, and the health-related consequences of these

exposures.  Since this objective is common to all health-related categories

(but not addressed within the five-year time frame), it has not been

listed separately, although it will be discussed briefly in Chapter 11.

             Vibration associated with noise is also a significant source

of annoyance and discomfort.  As discussed in the Panel report referred

to earlier, the relative contributions of noise and vibration need to be

assessed in order to derive criteria for the combined exposure conditions.

However, vibration effects have not been listed separately within this

Research Plan, but instead are contained as an intrinsic consideration

within each of the seven categories of noise effects research.  It should

also be mentioned that there is some ongoing Federally sponsored, health-
                                 1-7

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related research concerning Che effects of vibration, most notably by




the U.S. Air Force, the U.S. Army, and the National Aeronautics and Space




Administration.




             It should be noted that the EPA Five-Year Research Plan does




not constitute a full Federal program of needed research.  While the proposed




Research Initiatives and respective funding levels address most of the highest




priorities, they do not represent a comprehensive research program.  Such




an effort would require a combined Federal approach of much greater magnitude.








1.3          Reader's Guide to the Research Plan




             The body of this Research Plan consists of a set of plans—




one for each category of noise effects research.




             The following chapter explains how priorities were set for the



EPA Noise Effects Research Plan.




             Chapter 3 presents an introduction to the specific Research




Plan for each category, and defines concepts such as "Research Initiative"




and "Research Continuum" which are common to all of the Plans.




             The specific Research Plans for each category of noise effects




including exposure characterization, are presented in Chapters 4 through 11.




Each chapter contains an overview of the current status of• research and




health effects information, a selected set of proposed Research Initiatives,




and the proposed timing, funding, and coordination of the Initiatives.




Additional Initiatives that will not be undertaken by EPA are also identified.




             Chapter 12 provides aggregate and summary data on the entire




Plan and how it relates to the core Five-Year EPA Noise Program Plan.
                                 1-8

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       2.  OVERALL PRIORITIES FOR EPA NOISE EFFECTS RESEARCH PLAN



            This Plan outlines a viable operational research program for

EPA to pursue in the noise effects research area for a five-year time

frame, commencing in Fiscal Year 1981.  The first requirement of the

Plan is to establish priorities for the eight categories of research

previously identified.  Although each category and its respective research

objective is felt to be important in its own right, relative priorities

must be established due to the reality of limitations in resources and

time.  Thus, each category was evaluated on a scale from high priority

to low priority, signifying where emphasis needs to be placed.  Each

category has been assigned one of five priority levels,  from "A" (highest

priority) to "E" (lowest priority).  This prioritization was based on a

rating and trade-off among five evaluation factors:

            o     Severity of the particular health problem, as perceived
                  by EPA, based on such available data as the number of
                  Americans affected, and potential severity of the
                  insult (potential magnitude of health effects)

            o     Program needs of EPA* s national noise abatement pro-
                  gram for specific research results within specific
                  time frames

            o     Scientific recommendations of experts  concerning the
                  degree to which additional research is urgently
                  needed

            o     Scientific feasibility of carrying out the needed
                  research within reasonable time,  with  reasonable
                  resources

            o     Appropriateness of EPA activity,  in the context of
                  whether an organization outside EPA—usually another
                  Federal agency—is already performing  the needed
                  research
                                   2-1

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            In performing the evaluation of overall priorities among



categories, each of these five factors was evaluated (as high, medium or




low) and then weighted.  For example, if EPA research in a specific




category was evaluated to be "high" in appropriateness, it meant that




the needed research was not being conducted elsewhere and would not be




accomplished without the commitment of EPA resources.  However, not all




factors were considered equally important.  The most important considera-




tions were the severity of the health problem and the degree to which




the proposed research would meet EPA program needs.  These were weighted




accordingly.
2.1         Overall Results of Priority Analysis




            Based on these evaluation factors, the overall priorities of



the noise Research Plan are given below, with short explanations of the



ratings.  It should be noted that although a category may be rated as



low or medium in priority, pending EPA or State and local actions may




require that a certain Initiative be investigated.  This will be explained




in more depth when the operational Research Plans are presented for each



category in Chapters 4 through 11.
Level of
Emphasis
Importance Rating Category
Highest
/



priority A Nonauditory Physiologic Effects
ik.
B (1) Sleep Disturbance
(2) Individual and Community Response
C (1) Noise- Induced Hearing Loss
(2) Behavioral, Social, and Performance
Effects
D Communication Interference
Lowest priority E Effects of Noise on Wildlife and Other
                              Animals
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2.2         Level of Emphasis A (Highest Level)

2.2.1       Nonauditory Physiologic Effects*

            This research area is the highest priority because it has

the greatest potential health implications and no other Federal agencies

are adequately researching this category.

            Severity.—The potential health problem posed by nonauditory

physiologic effects is very great.  Noise, like other physical stressors,

is capable of producing a variety of physiologic stress responses in the

body.  Stress has been linked to a number of chronic diseases prevalent

in our society.  Although there are scattered findings associating noise

with a number of health problems, the best-documented relationship is

the one between noise and elevated blood pressure and related cardiovas-

cular problems.  Heart disease ranks as the number one cause of death in

America.  Hypertension—the most likely specific effect of noise—is a

demonstrated risk factor in the development of heart disorders, stroke

and kidney disease.  It is conservatively estimated that from 23 to 27

million Americans suffer from hypertension.  For a very large proportion

of these cases (90 percent), the causes are not known; yet hypertension

contributes to 250,000 deaths annually in the United States.  If, as

some evidence suggests, there is a cause-effect relationship between

noise and hypertension, the health implications of such a relationship

would be widespread and serious.  In addition to cardiovascular effects,

other nonauditory physiologic effects of noise may be equally serious.
* This category covers physiologic effects other than the physiologic
  effects of noise on the ear.
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That is why it is urgent to find out as soon as possible the extent to




which such relationships exist.




            Program Needs.—EPA's need for better information in this




category is very great because all of EPA's noise abatement program




activities are based on the need to protect the public health and welfare.




To the extent that EPA's criteria presently in use (annoyance, hearing



loss, activity interference) do not take into consideration some of the



most serious effects such as the potential for cardiovascular disorders,



they are deficient.  While it is unlikely that the first five years of



nonauditory physiological research will yield the kind of quantified




criteria which the EPA program requires, it might verify the extent to




which the noise/physiologic health relationship exists, and thus change



both the direction and importance of the EPA noise abatement program.




            Scientific Recommendations.—Health scientists from all over



the world have recommended that more attention be given to nonauditory



physiologic effects of noise.  These recommendations are based upon the




findings of research to date.  The Third International Congress on Noise




as a Public Health Problem (Freiburg, West Germany, 1978) pointed out



the necessity for giving priority to this research.  Since the previous



International Congress in 1973, at least 123 reports of related research



studies have been published in the international literature, dealing not



only with the heart and circulatory system, but also with effects on



vision, fetal development, biochemical constituents of the bodily system,



the digestive system, the muscular system, and the nervous system.
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            A committee (CHABA Working Group 81) of the National Academy




of Sciences has recently recommended that investigation of the relation-




ship between noise and medically significant physiological responses be




accelerated, with cardiovascular measures as the initial focus.




            Moreover, a recent Workshop of Cardiovascular Experts at the




Massachusetts Institute of Technology underscored the plausibility of




the linkage between noise and cardiovascular problems, and urged that a




high priority be placed on research in this area, including epidemio-




logical research.




            Scientific Feasibility.—There are some definite methodologi-




cal difficulties involved in conducting research on the nonauditory




physiologic effects of noise.




            Understanding the ways in which noise can change the body's




dynamic physiologic systems requires a serious and in-depth program of




research.  A coordinated program of animal, human clinical, and epidemio-




logical research is essential.  Conducting valid research in this area




requires the blending of advanced acoustic measurement with sophisti-




cated and detailed monitoring of physiological indicators in both acute




and chronic exposure situations.  For the most part, the techniques are




currently available; the problem is bringing them to bear on the study




of noise effects.  The essential development of quantifiable dose-




response criteria depends on the careful and logical accumulation of




causal data.  It is optimistic to think that any single study or set of




studies will yield the type of data that EPA needs.   Although the prob-




lems standing in the way of good research in this category appear
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formidable, the challenge is not different from that faced in most areas




of biomedical research.




            Appropriateness.—It is unlikely that the required research




will be performed without EPA action.  Based on a review of research




being conducted or sponsored by Federal agencies, no relevant research



efforts are currently being sponsored by other agencies, except for a




joint EPA study with the National Institute of Environmental Health




Sciences, currently in progress.  Therefore, an active EPA initiative in



the nonauditory physiologic effects category, particularly in research




concerning the cardiovascular system, will not be duplicative of other




efforts.  It appears that EPA must take the lead in this category of




research, at least in the initial years of study.








2.3         Level of Emphasis B



2.3.1       Sleep Disturbance



            Severity.—Millions of Americans live in areas where the



potential for nightly sleep disturbance by noise is high.  Such residen-



tial sleep interference is one of the primary contributors to irritation



and annoyance by neighborhood noise.



            Some subjective effects of sleep disturbance that have been



reported are fatigue, irritability and poor work performance.  Often, a



greater susceptibility to illness has been attributed to a poor night's



sleep.  Nevertheless, none of these suspected effects has been fully



explored or measured.
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            Chronic sleep disturbance is a potentially severe health




problem, yet little is known about the long-term effects of sleep distur-




bance on health, the national incidence of sleep disturbance by noise,




and its effects on subsequent task performance and safety implications




on the job, in traffic and in other settings.




            Program Needs.—EPA currently uses two criteria (awakening,




and sleep disturbance or changes from deeper to lighter sleep) to




quantify the benefits of noise control actions.  These benefits are then




weighed against costs.  Although adequate for Federal regulatory purposes,




the present criteria have several limitations that affect their




generalizability to different noise sources, to typical sleeping condi-




tions in the home, and to various population subgroups (the elderly, the




ill, and others).  Thus, there is a pressing need for an EPA research




effort in light of both the limitations in applicable research findings,




and EPA programmatic needs to relate better the impact of sleep distur-




bance (including health and performance effects) to nightly noise levels




that potentially interfere with sleep.




            Scientific Recommendations.—In 1978 the Federal Noise




Effects Research Panel recommended that considerably greater funding be




applied in the sleep category, noting that funding levels had dropped




since the Panel's 1975 report and that certain recommended research had




received no attention.  The Panel recommended that attention focus on




chronic sleep interruption by noise, and on the effect of sleep inter-




ruptions on special populations such as the ill and the aged.
                                   2-7

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            Similarly, experts at the 1978 International Congress on




Noise as a Public Health Problem emphasized the need for noise effects




researchers to determine the effects of acoustic and nonacoustic variables




on sleep quality, while encouraging general sleep researchers to continue




to study the effects of sleep quality on general health.




            Scientific Feasibility.—As in the nonauditory physiological



effects category, there are a few methodological difficulties to be



overcome.  One of the primary methodological problems confronting scien-



tists is the difficulty of transferring research activity from laboratory




to residential settings.  Nevertheless, in-the-home techniques have been




pioneered in this country and similar techniques are currently in use in




Europe.




            Appropriateness.— The relative lack of other applicable




research makes EPA action necessary.  Over the last five years only



limited sleep research has been performed by other Federal agencies and




these research studies have principally focused on aircraft noise.








2.3.2       Individual and Community Response



            Severity.—It is estimated that well over 100 million



Americans are exposed to noise that is perceived to be unwanted,



unnecessary, objectionable, and disturbing.  Noise levels that are known



to cause annoyance and interference with everyday activities emanate from



common sources including road traffic, aircraft, construction activity,



and household products to name but a few.  Thus noise in our communities



today is pervasive and intrusive.
                                   2-8

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            Annoyance  that occurs as a result of exposure to noise is a




complex psycho-social  reaction.  Although annoyance has as its basis the




unpleasantness associated with noise and the disruption of ongoing




activities, the response may ultimately lead to complaints or produce




strong group reactions against certain noise sources.  This type of




annoyance response has not yet been experimentally identified with



adverse physiologic reactions.  Instead it is related to subjective



feelings of irritation, being upset, and a general lack of well being.




            Nevertheless, increasing evidence of a possible association



between excessive noise and stress-related health problems, such as



hypertension and digestive changes, may link the annoyance or irritation



that we commonly feel  toward noise to the undesirable health effects



that may occur.  Although this link has as yet not been scientifically



or experimentally established, it is not unreasonable to view our




annoyance reactions as a biological protective mechanism - a warning or



symptom of unwanted health effects.  For instance, recent community



noise surveys are starting to reveal a relationship between those persons



who are highly annoyed by noise, and who feel that noise may be adversely



affecting their health and welfare.




            Program Needs.—The category of individual and community



response is most important in that individuals'  subjective (annoyance)



reactions to noise have in fact been the primary impetus for the estab-



lishment of Federal, State and local noise control programs throughout



the United States.   Moreover, quantitative information that is available



with respect to community response has formed the basis for noise emission
                                   2-9

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regulations,  policy, and guidance promulgated at  the Federal governmental




level.  Community noise criteria, in the form of  the percentage of




people expected  to be highly annoyed at specific  noise levels, are  the




primary human response criteria used in noise control policy and




legislation.  These criteria have predominately been developed in a




number of studies of traffic and aircraft noise in an attempt to better




ascertain general community or group response to  noise.  Although adequate




for Federal regulatory purposes, the generalizability of these criteria



to specific sources of noise such as construction activity and railroad




noise has been questioned.  As the number of different noise sources




that must be  considered by Federal, State and local noise programs




increase, it  is anticipated that more specific criteria applicable  to




specific sources or noise settings will be needed.




            Moreover, studies completed to date have not accounted  for



many of the acoustic and nonacoustic factors that shape our response to



noise.  Severe programmatic limitations exist in  understanding the



influence upon individual and community reactions of certain acoustic



attributes typical of many noise sources found in the community.   These



attributes include perceived tonal components,  impulsiveness, fluctuation



in level, intrusiveness over background noise,  and so forth.  Methods do



not exist that properly account for the expected  increase in adverse



community reactions that typically result from these factors.  Moreover,



the large individual differences that typically occur in annoyance



responses have not been accounted for.   The result has been a rather



pragmatic approach to the matter of assessing community and individual
                                   2-10

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response to noise.  There exists no noise annoyance calculation procedure



that deals satisfactorily with the many acoustic and nonacoustic variables



that influence our subjective responses to sound and, accordingly, our




perspectives on the quality of our life.




            Cost effective noise abatement decisions and actions are



highly dependent upon the refinement of existing criteria pertaining to




individual and community response, both in environments dominated by



specific noise sources, and in environments with diverse noise attributes.




            Scientific Recommendations.—There exists a general consensus



within the scientific community on the need for further research and the



direction it should take.  Scientific recommendations, including those



made at the 1978 International Congress on Noise, as well as those in



the forthcoming World Health Organization document on environmental




noise criteria, point out that while aggregate community response to



noise can be reliably predicted, more work investigating the mediating



factors is needed to help account for the great individual variation in



response.  Further, the stress-related components of response also



require more investigation.  In addition, as communities experience



changes in their noise environment, longitudinal studies should be



conducted to assess adaptation and societal changes in public reaction



to noise.




            Scientific Feasibility.—Research in this category has a



high expectancy of achieving useful results because it is based on very



successful, well-established techniques (attitudinal survey methodologies



and psychoacoustic test procedures) that are commonly used to study
                                   2-11

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subjective human reactions to noise.  Improved subjective and acoustic




measurement methodologies are now available.



            Appropriateness.—Although other Federal agencies are active




to some extent in parts of this research area, the research gaps left




are sufficiently critical to require EPA activity.  Recent Federal




efforts, primarily by the National Aeronautics and Space Administration,




the National Bureau of Standards, and the Air Force, have been significant,




but have focused on relatively narrow study areas, mainly aircraft




noise.  Information needs specific to EFA's program requirements have



not been fulfilled by these other research efforts.








2.4         Level of Emphasis C








2.4.1       Noise-Induced Hearing Loss



            Although much additional research in noise-induced hearing



loss (NIHL) is needed, feasible, and related to EPA program needs, EPA



is placing only medium emphasis on its role, largely because of the in-



depth research programs already being undertaken by other Federal agencies.



            Severity.—Noise-induced hearing loss is the most widespread



occupational health problem in the United States, and there is evidence



that additional noise exposure from environmental sources exacerbates



the problem.  Of the estimated 20 to 25 million people in the United



States exposed to levels of noise sufficient to cause irreversible



damage to their hearing, 15 million are estimated to be workers exposed



to noise on the job.  Impulse noise is a particularly severe problem
                                 2-12

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in the occupational setting which has not been adequately addressed.  It




is estimated that over 2.7 million workers are exposed to impulse noise




and are not covered adequately by present damage risk criteria.  It is




particularly important to consider the problem of workers whose workplace




exposures are augmented by off-the-job exposures.  Other potentially




hazardous exposures occur in transit, in using appliances and power




tools at home, and in common recreational activities.  Preliminary




information also suggests that people in comparatively low noise work




environments such as office workers and homemakers are exposed to 24




hour noise exposure levels which may place some of them at higher risk




to hearing damage.




            It is estimated that as many as 19 million Americans suffer




from a handicapping hearing loss.  Persons suffering from noise-induced




hearing loss often report other health disturbances as well.  They are




also frequently the victims of tinnitus (ringing in the ears), lowered




auditory discomfort thresholds and other annoying side effects.  Impaired




hearing can be socially debilitating.  Persons with NIHL often speak of




difficulty in understanding communication, withdrawal from social contacts,




embarrassment, frustration and isolation.   Noise-induced hearing loss




greatly affects the lives of millions of individuals.  It is a difficult




problem since the process is gradual and insidious and may not be apparent




until a considerable amount of hearing is  lost.




            Program Needs.—Although scientifically acceptable damage




risk criteria exist,  EPA requires better defined hearing loss criteria




to support its regulatory and Federal coordination programs for
                                   2-13

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environmental noise sources.  The probability that a person will develop




a noise-induced hearing loss depends on the individual's total exposure




from all noises at work, home, and in the community.  A determination of




those sources and each source's contribution to an individual's risk of




hearing loss will provide added direction to governmental regulatory




programs and development of appropriate actions.




            Scientific Recommendations.—There is a widespread consensus




on the need for further research on the key segments of the NIHL research




category, as characterized by conclusions reached at the 1978 International




Congress on Noise, a recent NIH workshop on noise research, the Federal




Noise Effects Panel Report, and the forthcoming World Health Organization




(WHO) report.  As recommended by these groups, future research should




concentrate on some of the less well defined aspects of the problem such



as the question of hearing loss caused by specific environmental sources,



the effects of intermittent and impulsive noise, and the question of



determining risk to susceptible populations such as children.  These



areas have in the past received a low level of funding and need to be



addressed at the present time.




            Scientific Feasibility.—The feasibility of ongoing and



planned NIHL research is generally high.  It is solidly based on research




performed over the last 30 years.   The development of new sophisticated



personal monitoring instrumentation,  clinical methodologies and micro-



scopic assessment techniques makes research possible now that could not



have been undertaken several years ago.
                                   2-14

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            However, in the future, certain avenues of research will be




limited.  For one, workers should not be exposed to high noise levels




which may jeopardize their hearing.  Effective enforcement and compliance




with Federal workplace noise provisions will make it difficult to identify




workers for hearing loss field studies.  If workers exposed to high




levels of noise were found, it would be irresponsible not to take neces-




sary actions to provide them with adequate hearing protection.  Secondly,




many research institutions are finding it difficult to obtain approval




for human subject research under high noise exposure conditions.




            Appropriateness.—Over the last five years, seven different




Federal agencies have devoted considerable resources to numerous NIHL




studies.  Approximately 20 studies related to aspects of NIHL of particu-



lar interest to EPA have been funded at a cost of over $1 million per




year.  Due to the continuing interest of other agencies in funding NIHL




research, EPA will assume a very limited but focused research role in




areas not presently being adequately covered.








2.4.2       Behavioral, Social and Performance Effects




            The category of behavioral, social, and performance effects




of noise is an extremely broad category, whose effects are often subtle,




complex, and indirect,  and usually mediated by nonacoustic factors.




            Severity.—Although the scientific literature contains many




potentially important findings,  not enough information exists at this




time to allow proper consideration of the severity of noise effects.




Enough is known,  however,  to identify those areas that are most important
                                   2-15

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   and most in need of research.   There are some definite indications of

   anti-social and aggressive behavior resulting at least indirectly from

   noise,  performance decrements  due to noise,  learning disabilities

   attributed to, or aggravated by noise,  and stress-related psychological

   responses that may be due in part to noise.   Some very important questions

   exist concerning the way in which individuals adapt to and cope with

'   noise,  and how the performance, productivity and social and personal

   adjustment of adults as well as children may be impaired by noise.

               Information is particularly needed on how noise affects the

   development of language and cognitive skills in children.  Some of the

   most pervasive effects of noise fall within this category.  These are
                                                         •yVHH      q/
   important questions because they pertain to  how noise ^interferes/with
                                               j\M«^>^**
   personal, mental and social functioning and  majees the accomplishment of
                                             /I/
   important goals more difficult.

               Program Needs.—The adverse behavioral,  social and performance

   effects of noise are clearly relevant to EPA program requirements.   At

   present,  EPA has no criteria for any of the  effects that noise may have

   on behavior and/or performance.  To the extent that further research

   enables effects to be quantified in the form of criteria, they can and

   must be included in assessments made in support of regulatory programs

   and State and local activities.  For example,  definitive information

   concerning how noise affects the acquisition of language and other

   cognitive skills may necessitate that special consideration be given to

   noise around schools and residential environments,  and to the modification

   of existing communication interference  criteria.   Information on behavioral
                                   2-16

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and social problems associated with noise exposure would have a direct




application to regulatory actions and State and local noise program




activities.  This category of effects may be especially important where




levels of exposure are only moderately high or where contextual factors



characteristic of the exposure situation appear important.




            Scientific Recommendations.—Recent international scientific




congresses on noise have emphasized both the potential significance and




the extreme complexity of these problems.  One of the general areas that



has been identified for future research is in the determination of the



sociological effects of noise in relation to the quality of life.  Other




gaps in the scientific literature have been identified and a more realis-



tic posture has been taken toward the level of sophistication required



to attack these multivariate research questions.



            Scientific Feasibility.—The complexity and subtleness of



noise effects in this category necessitate the use of sophisticated and



elaborate research designs and detailed, multivariate techniques for



data analysis.  The fact that noise seldom occurs alone in natural



settings requires that an effort be made to ensure that research outcomes



are attributable to noise.  In spite of these difficulties, a number of




behavioral science and sociological methodologies are available for



carrying out a program of research and systematic replication which



could be expected to yield results of use to EPA noise abatement activities.



            Appropriateness.—Due to the relative lack of activity



elsewhere,  EPA will need to take the lead if this important area is to



be investigated to any significant degree.   Even the ongoing task
                                 2-17

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performance research is not directly applicable to the environments of



concern to EPA.  The relatively small amount of ongoing research on the




effects of noise on children is exploratory in nature and will be used




by EPA in planning more focused research in this important area.








2.5         Level of Emphasis D








2.5.1       Communication Interference








            Severity.—In terms of severity of the problem, everyday




experience shows that almost all Americans are exposed to noise at




levels sufficient to interfere severely with their activities at home




(including conversations and listening to TV, radio, or recorded music),




in transit, and at their workplace.  Interference with speech communica-



tion is more than an annoyance.  It represents a reduction in efficiency,



and in some circumstances a real threat to safety resulting from messages



being missed or not understood.



            Program Needs.—Investigation of communication interference



is highly relevant to EPA noise program needs because much of the existing



regulatory program is based on well quantified criteria for speech



interference.  While these criteria are adequate for Federal regulatory



purposes, they may need refinement to ensure their suitability in non-



steady state background noise conditions and for listeners other than



normal hearing, native adults.
                                   2-18

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            Scientific Recommendations.—There is consensus on the



directions for continued research including:  extension of the generaliza-




bility of research based on communication systems; increased emphasis on




quality of communication; requirements for communication in fluctuating




noise situations; and the speech communication requirements of special




groups such as the very young and hearing-impaired listeners.



            Scientific Feasibility.—As one of the older and better



established disciplines, communication interference is well suited for



further study with the well developed methodologies available.



            Appropriateness.—The relatively large amount of Federal




activity already underway may minimize the need for EPA emphasis, with a




few exceptions.  EPA's interest in conducting additional work is limited



to rather well-defined topical areas not presently being adequately



covered.  These include development of refined criteria for the effects



on special groups such as children, special effects in teaching and



learning activities, and secondary effects of disrupted communication on



safety and task performance.








2.6         Level of Emphasis E








2.6.1       Effects of Noise on Wildlife and Other Animals



            Severity.—The severity of noise effects in the animal



kingdom is unknown at this time.  It is known that for many species



there is behavioral habituation to the use of noise as a deterrent



(e.g., to keep birds from farm crops).  More shy species,  however, may
                                   2-19

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 respond to  noise by retreating  from the  site of  human activities,




 reducing territorial coverage and,  possibly, population  size.   It  is




 doubtful that this  can be  considered a noise effect,  and is more likely



 a  response  to human land use.




            There are certain known effects of noise  on  domestic animals




 such  as livestock and fowl.  These  effects include undesirable  changes




 in color and  quality of meat, and effects on hatching of eggs.




            The  potentially  serious effects of noise  as  a masker on




 species which rely  on aural  communication for safety  from predators are




 not known.  Nor  do  we know the  effects of environmental  noise on any



 endangered  species.




            Program Needs.—Many State and local governments look  to EPA



 for information  on  wildlife noise effects largely for purposes  of




 Environmental Impact Statements and proposed highway  and airport projects.



 A  large number of inquiries are received in this area.   In EPA's regula-



 tory  program,  knowledge of effects  of noise on animals would help  to



 quantify  the  benefits  of noise control, particularly  for recreational



 and off-road  vehicles.




            Scientific Recommendations.—The Ninth International Congress



 on Acoustics  (in  1977)  held a special symposium on questions of noise



 effects on  animals,  stressing the importance of understanding how noise



may affect  the ecosystem.  This symposium prompted a  session at the



Third International Congress on Noise as a Public Health Problem (1978).




At both meetings, results of a few  studies were reported, but concern



was expressed  that very little is known at present,  and no conclusions



could be drawn.
                                2-20

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            Scientific Feasibility.—Full study of this problem would




require an enormous research effort.  Whereas in studying domestic



animals, experimental controls and measurement techniques are relatively



simple, studying animal responses in the wild is more difficult, particu-



larly because it is desirable to do long-term studies of noise effects.




Telemetric techniques are available and feasible for some species, but



more investigation will be necessary.




            Appropriateness.—While EPA has some statutory authority in



this area, other agencies have more clear-cut missions related to environ-



mental effects on wildlife and domestic animals and have sponsored some



research on noise effects.  Given their respective missions, it is more



appropriate for this work to be conducted by agencies other than EPA.



EPA's proper role may be seen as promoting and coordinating this research.
                               2-21

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             3.  EPA'S  RESEARCH  PLAN  IN  DETAIL  (INTRODUCTION)









3.1          Definition of Long-Range Objectives




             Developing a comprehensive Research Plan requires as an




initial step the defining of long-term objectives for each of the




categories of health effects research.  These objectives have been




defined as broadly as possible in Chapter 2 in the light of EPA1s




research and program mandate, so that if they were fulfilled, the national




noise abatement program would have an adequate "health and welfare" infor-




mation base.  This information base is needed to support future activities



that will effectively and efficiently minimize adverse noise in our




environment at the lowest cost possible and with the least disruption to




our lives.  Obviously,  as general targets to be aimed at, these long-term




objectives will be used for purposes of reference.








3.2          Definition of Short-Term Objectives and Base Year




             The specific Plan presented here covers the time period from




Fiscal Years 1981 to 1985.  EPA1s short-term research objectives are those




which have been selected for initial action within this period.   The




short-term objectives,  therefore, represent a set of limited but important




milestones in pursuit of the identified long-term objectives.




             Note also  that base year research activities, for the purpose




of this Plan, are those occurring in the pre-Plan year, Fiscal Year 1980.
                                3-1

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3.3          Definition of Research Initiatives




             Corresponding to each short-term objective in the Plan are




one or more Research Initiatives.   Each Research Initiative is conceived




as a particular line of inquiry in pursuit of a specific,  identified




objective.  Research Initiatives will be time-phased,  both because of




resource constraints and because of the intent that outputs of some




Initiatives will act as prerequisites necessary to initiate others.




Further, a given Research Initiative should not be thought of as a




"project" or "program."  In many cases a given Research Initiative will




consist of a number of components which are frequently supported by one




or more projects in a time-phased manner.  A list of identified Research




Initiatives within each research category is contained in Table 3-1.








3.4          Concept of Evolution in Research




             Underlying the approach taken by EPA is the fact that the




research categories for which long-term objectives have been set differ from




each other in at least one important respect:  the maturity of research




activity in the category.  For long-established categories, information is




organized around well-defined and generally accepted concepts and methodologies.




Furthermore, there is a group of recognized specialists pursuing more advanced




questions such as the refinement of criteria or the investigation of the




specific health risk to special populations.  Other categories, which only




recently have begun to be recognized, are still developing conceptually,




and frequently need to involve specialists from unrelated fields organized




in a cross-disciplinary, biomedical research effort.  In this case the problem





                                3-2

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                                TABLE 3-1
                     IDENTIFIED RESEARCH INITIATIVES
NONAUDITORY       I.  Animal Experimental Studies on the Relationship
PHYSIOLOGIC           Between Noise, Elevated Blood Pressure and Other
EFFECTS               Cardiovascular Effects

                 II.  Epidemiologic Studies on the Relationships Between
                      Long-Term Noise Exposure and Adverse Cardiovascular
                      Effects

                III.  Human Clinical Studies of Cardiovascular and Neuro-
                      endocrine Responses to Noise

                 IV.  Nonauditory Physiologic Effects Other Than Cardio-
                      vascular Effects
SLEEP
DISTURBANCE
COMMUNITY
AND
INDIVIDUAL
RESPONSE
  I.  Relationship between field and laboratory data on
      sleep disturbance by noise

 II.  Health consequences of noise-disturbed sleep

III.  Acoustic parameters related to sleep disturbance

 IV.  Susceptibility of sensitive populations to sleep
      disturbance by noise

  V.  Adaptation to sleep disturbance by noise


  I.  Determination of the magnitude of community and
      individual response attributable to specific
      sources of noise.
                 II.  Determination of the relationship between specific
                      acoustic attributes and the magnitude of individual/
                      group response to noise.
NOISE-
INDUCED
HEARING
LOSS
  I.  Determination of the incidence of NIHL in the United
      States and contribution of sociocusis (nonoccupational
      NIHL) presbycusis (aging), and occupational  hearing
      loss.

 II.  Establishment of parameters of individual sensitivity
      to NIHL.

III.  Refine criteria for low-level  noise exposure.
BEHAVIORAL,
SOCIAL AND
PERFORMANCE
EFFECTS
  I.  Effects of Noise on Cognitive and  Social  Development

 II.  Behavioral and Social  Adjustment to Noise


                 3-3

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may not be well enough defined, the results are less consistent,  the




methodological problems are greater, and the probability of failure is




higher than for research in the more established categories.   For any




of the categories of research presented in Chapters 4-11, a logical




and scientifically developmental sequence of research activity can be




suggested.  This sequence is typically followed in the development of




quantified dose-response relationships, the determination of health-




effects risk, and ultimately, the development of refined human response




criteria.  These are steps in an empirical research process.   This




sequence is shown in Table 3-2.  Thus, certain types of research are




the building blocks on which progress in the more advanced topics depends.




The kinds of results that can reasonably be expected from new research




depend in part on where the research category falls on this research




developmental continuum.




             In some areas of research where the health effect is




critical, research may be undertaken out of sequence.  The attempt to




develop criteria in the shortest possible time often results in wasteful




research, large funding expenditures, many unanswered questions,  and




continued debate over the implications of the results.  In introducing




the Research Plan for each objective, therefore, an attempt will be made




to place the current status of research in that category somewhere




on this developmental continuum.  For example, while research in the noise-




induced hearing loss and communication interference categories are relatively




highly developed specialities, research in the nonauditory physiologic




effects category belongs at the other end of the spectrum.  That is,




research proposed in the category of noise induced hearing loss will lead



                                 3-4

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                                TABLE 3-2

         RESEARCH CONTINUUM IN THE DEVELOPMENT AND REFINEMENT OF
                         HEALTH EFFECTS CRITERIA
1.  Demonstrate the existence of an association

2.  Demonstrate a basic cause-effect relationship directly attributable

    to noise

3.  Investigate underlying mechanisms and physiologic bases of the effect

4.  Improve the cause-effect relationship through the investigation of

    intervening factors

    A.  Acoustic factors

    B.  Nonacoustic factors

5.  Establish dose-response relationships,  determine risk,  and develop

    quantified human response criteria

6.  Refine criteria based upon susceptible  populations and special

    considerations
                                3-5

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to the refinement of criteria,  whereas research being proposed in the




category of nonauditory physiologic effects will attempt first to




demonstrate a basic cause-effect relationship directly related to noise




exposure.




             In the Research Continuum Table included in each chapter




of this Plan, the status of research in each category is evaluated as




either "Adequate", "Marginal" or "Inadequate".  These labels denote




adequacy with respect to reaching the ultimate objective of fully




refined criteria for each noise effect category.   However,  these labels




do not reflect a judgment of adequacy for Federal regulatory purposes.








3.5          Contents of Che Research Plan for Each Category




             The total Research Plan consists of a separate Plan for each




of the eight research categories.  A number of Research Initiatives are




proposed in each category.   Each Plan will consist of the items shown




in Table 3-3.








3.6          Establishing Fiscal Year Funding Levels




             Overall EPA extramural funding for the Plan is projected to



increase from $1.2 million in Fiscal Year 1981 to $3.0 million in Fiscal




Year 1985.   The total EPA noise effects research budget is  projected to




be $10 million over the five-year period.   These levels were established
                                 3-6

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                                TABLE 3-3

          ITEMS INCLUDED IN THE PLAN FOR EACH RESEARCH CATEGORY

1.  Rationale for Selecting Specific Research Initiatives—For funding over
    the Five Year Period.

             o  What is Known.—Status of research in the category.

             o  What is Not Known.—Research that needs to be conducted
                to fill in important deficiencies in data and improve
                understanding of specific health effects.

             o  EPA Priorities.—Research requirements of EPA due to
                specific noise control program needs.

             o  Current Research Activities.—Ongoing research projects
               of EPA and other Federal agencies.*

             o  Position on the Research Continuum.—Status of research
                in relation to the development of refined health effects
                criteria.

             o  List of Planned EPA Research Initiatives for the Five Year
                Period.—Identification of specific lines of inquiry in
                pursuit of category objectives.

2.  Detailed Descriptions of the Research Initiatives.—Each description
    includes:

             o  Description and Basic Considerations

             o  Relation to Ongoing Non-EPA Research.—Federal and private.

             o  Expected Results.—How the results will be used upon
                completion of the Initiative.

3.  Timing and Funding of the Research Initiatives.—Chart.

4.  Monitoring and Coordination.—For example,  advisory groups that  will be
    established to evaluate progress of research and provide inputs.

5.  Research Initiatives That Will Not Be Undertaken by EPA.—Because of
    limitations in funding,  important Research Initiatives will not  be
    undertaken by EPA,  although other agencies may wish to pursue them.
[* Requests were made in early September to other agencies for this
   information.   Some responses have not yet been received,  and therefore
   were not included in the present Plan.   When this  information is
   obtained it will be incorporated into the appropriate  discussions.]
                                 3-7

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by using the first year funding of $1.2 million,* which was established

as a base under the Federal Zero Base Budgeting process.   Funding levels

for successive years were then established by applying an annual growth

rate factor which would be reasonable when judged by two criteria:

             o  Slow enough to ensure effective program management
                based on present staff Levels

             o  Fast enough to achieve the results required by the
                EPA national noise control program without undue delay.

             By trading off these criteria, it was determined that  an

optimum annual growth rate was approximately 25 percent.   The following

amounts are the proposed EPA extramural funding levels for research per

year.
           Fiscal Year          EPA funding levels in Plan
                                  (millions of dollars)

              1981                           1.2
              1982                           1.5
              1983                           1.9
              1984                           2.4
              1985                           3.0
3.7          Assumptions



3.7.1        Co-Funding by Other Agencies

             Co-funding of certain EPA Research Initiatives by other

Federal agencies is a distinct possibility in research categories where the

agencies have mutual interests.   Such co-funding is highly desirable
*  This figure does not include $200K set aside for general programmatic
   support.
                                3-8

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because it would allow more results to be obtained within the Five-Year




Plan period.



             However, only in the category of nonauditory physiologic




effects is co-support being assumed in the planning and design of the




specific EPA Research Initiatives.   The assistance of other agencies




is needed due to the urgency in which this information is needed, the




high costs of the required biomedical research and the requirement that




the research be pursued in a broad-based, multidisciplinary manner.




Furthermore, co-support is being assumed based upon the relevancy of the




planned cardiovascular research to research presently being supported by




the National Institutes of Health (NIH).  EPA foresees a shift in the




lead role to NIH by Fiscal Year 1986, after the initial thrust in cardio-




vascular research is completed and detailed results are available.  Only




with co-support during the next five years can EPA conduct the necessary




animal, human clinical and epidemiologic research to determine the extent




to which a basic causal relationship exists.








3.7.2        Nature  and Direction of Research Findings




             The Research Initiatives suggested for study within this




Plan are proposed with the aim of deriving findings that will lead toward




criteria development within each of  the research categories.  However,




there exist no guarantees on the results of the specific studies that




will be undertaken.  Biomedical research is by nature a continual learning




process.  Each step  of investigation at times necessitates re-definition
                                 3-9

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of new directions and replication of previous studies.  Depending on




research results, it may be necessary to restudy or replicate some areas




of research, and abandon others.
                                 3-10

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4.  RESEARCH PLAN FOR




    NONAUDITORY PHYSIOLOGIC EFFECTS

-------
                            TABLE OF CONTENTS
Contents                                                          Page
4.1   Rationale for Selecting Specific Research                   4-1
      Initiatives

      4.1.1     What is Known                                     4-1

      4.1.2     What is Not Known                                 4-3

      4.1.3     EPA Priorities                                    4-4

      4.1.4     Current Research Activities                       4-6

      4.1.5     Position on the Research Continuum                4-7

      4.1.6     List of Research Initiatives Selected for         4-9
                the Five-Year Period

4.2   Detailed Description of the Research Initiatives            4-12

                  I.   Animal Experimental Studies on the         4-12
                       Relationship Between Noise, Elevated
                       Blood Pressure and Other Cardiovascular
                       Effects

                 II.   Epidemiologic Studies on the               4-16
                       Relationships Between Long-Tenn Noise
                       Exposure and Adverse Cardiovascular
                       Effects

                III.   Human Clinical Studies of                  4-20
                       Cardiovascular and Neuroendocrine
                       Responses to Noise

                 IV.   Nonauditory Physiologic Effects Other      4-23
                       Than Cardiovascular Effects

4.3   Timing and Funding of Research Initiatives                  4-25

4.4   Monitoring and Coordination                                 4-25

4.5   Research Initiatives That Will Not Be Undertaken            4-25
      By EPA
                                   4-ii

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          4.  RESEARCH PLAN FOR NONAUDITORY PHYSIOLOGIC EFFECTS



4.1         Rationale for Selecting Specific Research Initiatives Over
            the Five-Year Period

            The long-term objective of nonauditory physiologic effects

research is to determine the physiologic effects of noise on bodily

systems and on general health, with special emphasis on hypertension and

other cardiovascular effects.



4.1.1       What is Known

            Studies have shown that noise acts as a biologic stressor.

Nonauditory physiologic stress reactions, such as transient changes in

blood pressure, heart rate and respiration, alterations in hormonal

levels and gastrointestinal motility, and measurable changes in skin

resistance and muscle potentials have been documented for noise exposures

typical in level to those encountered in the human environment.  The

hormonal changes and other effects produced in animals and humans to

noise appear to be similar to those elicited by other stressors.

            Laboratory research with rodents has yielded a variety of

both transient and enduring morphologic, hormonal and metabolic responses

to noise.  The generalizability of the results of these studies is

severely restricted due to the proclivity for convulsive behavior

("audiogenic seizures") among rodents and to the fact that the auditory

sensitivities of rodents differ considerably from those of humans.
                                   4-1

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             There is evidence that the fetus can be affected by noise




stimuli, either directly or through changes induced in the system of




the mother.  Only a very small amount of animal and human work has been




done in this area, but there are some preliminary data suggesting




stress-related adverse effects on biochemical activity, birth defects,




and birth weights.




             The consequences of long-term noise exposure on general




health status have been examined in several correlational field studies.




Overall, these studies have provided a complex and mixed pattern of




results.  There are data indicating that chronic noise exposure is




associated with a number of common health problems and complaints.  Not




atypical of field research, many of these studies are subject to criti-




cism on methodological grounds.  The major problem in this type of




research is determining whether noise per se is the cause of these




problems.




             By far, the most systematic body of research exists on the




relationship between long-term noise exposure and hypertension and other




cardiovascular problems.  Approximately 40 cross-sectional, retrospective




epidemiologic studies have been conducted, mostly in Eastern European



countries.  Research in ac least 11 different nations and in at least 18




different industries indicate increased cardiovascular morbidity as a




function of long-term noise exposure.  Hypertension appears to be the




most prevalent concomitant of noise exposure in these studies.  Although




it is difficult, for a number of reasons, to adequately evaluate these




studies, the apparent magnitude and consistency of these findings




cannot be ignored.
                              4-2

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             In addition, two recent studies, one in the United States




and one in Germany, have reported elevated blood pressure among children




living and/or attending school in high noise areas.  These studies are




particularly noteworthy in determining the significance of environmental




factors in the development of hypertension.




             Recent laboratory research in this country, using an appro-




priate animal model, the Rhesus monkey, has shown that as little as




several months exposure to environmental noise levels can produce signi-




ficant and sustained elevations in blood pressure of approximately




30 percent.  Furthermore, even a month after the noise was turned off,




the animals' blood pressures did not return to pre-exposure levels,




suggesting that recovery, if it occurs, will take some time.  This type




of controlled investigation, where noise is the only stressor present,




parallels past epidemiologic research, and suggests the importance and




the promise of study in this area of noise effects research.








4.1.2        What is Not Known




             Although it is known that noise acts as a stressor, it is




not known with certainty whether prolonged exposure results in cumulative




pathology.  Whereas the organism is often capable of adapting to noise




at the conscious, behavioral level, there appear to be physiologic costs




attached to this adaptation.  What is the overall medical significance




of these costs?  Precise cause-effect relationships need to be drawn




between noise and medically significant physiologic responses such as
                              4-3

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blood pressure, and between noise and the so-called stress diseases or




diseases of adaptation.




             Information is lacking on the mechanisms underlying noise




related changes and the extent to which noise operates in a similar




fashion to other better understood stressors.




             Quantitative data are virtually nonexistent concerning the




role played by the various physical parameters of noise, its level,




frequency spectrum, temporal pattern, and duration.  The extent to which




nonacoustic factors, or the context in which the noise occurs, mediate




the stress effects of noise is not known and must also be specified.




This is the type of information necessary to develop quantitative criteria




in support of noise control activities.




             Attention must be given to identifying those segments of the




population that might be particularly susceptible to these effects, for




example, children and the elderly.  Individual differences must be




investigated.  Information pertaining to the extent to which chronic




noise exposures might exacerbate pre-existing health problems such as




hypertension is not available.








4.1.3        EPA Priorities




             The most urgent EPA goal is to verify as soon as possible




the extent to which a cause-effect relationship exists between noise and




stress-related diseases such as cardiovascular disease, on the grounds




that the scope of the potential public health problem is great.  Noise




is probably the most pervasive pollutant in the occupational and
                              4-4

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non-occupational environment.  In recognition of the potential health




problem, the Quiet Communities Act requests that special emphasis be



placed on conducting research on the nonauditory physiologic effects of




noise.




            Statistical associations have been demonstrated between




noise and cardiovascular problems, but their ultimate significance



awaits further, more sophisticated research aimed at establishing



causality.  A combination of animal, human clinical and epidemiological




research is required.  Information must be obtained on the role of



various acoustic and nonacoustic variables, and on the susceptibility of

various sub-populations to noise-related cardiovascular effects.  This




type of information is required in order to develop quantitative dose-




response criteria.  Only limited attention will be given to in-depth




examination of basic mechanisms.  Although a fairly extensive and costly




program of research is required, the costs of ignorance are potentially




very great.




            EPA recognizes that little is known about any of the possible




nonauditory physiologic effects of noise, and that the health consequences




are potentially great for all of these effects.  EPA has, however,




decided to concentrate primarily on cardiovascular effects research




(since not all areas can be researched in depth simultaneously) for the




following reasons:




            (1) It is the best documented;




            (2) It is the most feasible scientifically;




            (3) It is linked to a serious and widespread health problem.
                                   4-5

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4.1.4        Current Research Activities




             EPA has already had more than three years experience spon-




soring nonauditory physiologic research.  The major EPA effort is an




investigation of the relationship of noise to sustained elevations in




blood pressure.  This study is being conducted at the University of




Miami and is funded by EPA with co-support from the National Institute




of Environmental Health Sciences (NIEHS).   EPA is also sponsoring an




epidemiologic feasibility study to be completed in Fiscal Year 1980.




This study will help lay the foundation for subsequent research.  It




will provide an objective assessment of the foreign epidemiological




literature, the analysis of key sets of foreign epidemiological data,




and an evaluation of various epidemiologic approaches.




             Beginning in Fiscal Year 1980, EPA will be obtaining descrip-




tive data from the National Health and Nutrition Examination Surveys on




the relationship between health status and indices related to noise




exposure (see Chapter 7 for the corresponding Initiative).




             Other Federal agencies appear to have little additional




related research planned or in progress.  The only exceptions are the




following studies.




             o     In the cardiovascular effects category,  a study spon-




                   sored by the Veterans Administration is examining the




                   effects of stress-producing, unpredictable noise




                   bursts on groups of "coronary-prone" or "non-coronary-




                   prone" men.  The study will ultimately look at poten-




                   tial cardiopathology as a result of noise-induced




                   stress.
                               4-6

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            o     An ongoing NIH/NIEHS project is looking at several




                  physiologic effects of noise such as teratogenic,




                  hormonal and cardiovascular effects.




            o     A study by the National Institute of Child Health and




                  Human Development is examining the effects of high




                  noise levels caused by aircraft noise on the physical




                  growth and development of children.




            o     A study supported by the National Science Foundation




                  and NIEHS includes an investigation of the blood




                  pressures of children living near a large airport.








4.1.5       Position on the Research Continuum








            As can be seen in Table 4-1, the present status of research




in the nonauditory physiologic effects category must be considered




almost wholly inadequate for the development of human risk criteria.  It




is only in the cardiovascular effects area that a reasonable amount of




associative data exists.
                                   4-7

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                                  TABLE 4-1



      POSITION ON THE RESEARCH CONTINUUM - NONAUDITORY PHYSIOLOGIC EFFECTS


     Research Continuum                                Current State of Knowledge

                                                     Adequate   Marginal  Inadequate

1.   Demonstrate existence of an association                        X*

2.   Demonstrate basic cause-effect relationship

          A.   Animals                                                        X**

          B.   Humans                                                         X*

3.   Investigate physiologic mechanisms                                       X**

4.   Investigate intervening factors.  Improve
       causal effect relationship

          A.   Acoustic                                                       X

          B.   Nonacoustic                                                    X

5.   Quantify dose-response relationship                                      X

6.   Refinement and special populations                                       X
 *    Foreign epidemiological research suggests a statistical association
      between noise and hypertension and other cardiovascular problems.
      Some experimental primate research also shows- adverse effects on the
      blood pressure.

**    EPA/NIEHS is supporting ongoing research which involves the examination
      of physiologic dynamics and causal mechanisms.
                                      4-8

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4.1.6       List of Research Initiatives Selected for the Five-Year Period


            After reviewing the status of nonauditory physiologic

effects research, EPA program needs and priorities, and the planned

research activities of other Federal agencies, the following Research

Initiatives for EPA funding have been selected for the next five years.

They are not listed in order of priority.

              I.  Animal Experimental Studies on the Relationship
                  Between Noise, Elevated Blood Pressure and Other
                  Cardiovascular Effects

             II.  Epidemiologic Studies on the Relationships Between
                  Long-Term Noise Exposure and Adverse Cardiovascular
                  Effects

            III.  Human Clinical Studies of Cardiovascular and Neuro-
                  endocrine Responses to Noise

             IV.  Nonauditory Physiologic Effects Other Than Cardio-
                  vascular Effects
            The assumption was made in selecting these Initiatives that

there will be co-support from other Federal agencies, increasing from

small scale funding initially to significant amounts at the end of five

years.

            The timely execution of these Initiatives with an adequate

level of support will require assistance in the form of co-support from

other Federal agencies.  The type of research proposed herein is multi-

disciplinary in nature, requiring expertise in a number of biomedical

and bioacoustical areas.  The participation of more than one agency will

insure more effective research design,  monitoring and review, and will

provide research outcomes with programmatic relevance to more than one
                                   4-9

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agency.  Biomedical research is very expensive to conduct, and EPA




recognizes that, where feasible, costs should be shared in order to




avoid duplication and superficiality.  As pointed out previously, the




potential costs of ignorance in this area are great.  A concerted program



of research is required in order to make significant progress during the




five-year period covered by this Plan.




            In the text that follows, Research Initiatives will be




proposed which assume co-support by other agencies at a level of 25 per-




cent in Fiscal Year 1982, climbing steadily to 43 percent in Fiscal Year




1985.  Table 4-2 contains the estimated levels of co-support over the




five-year period.  Major components of these Initiatives will be described




which contain funding levels and time periods based on this co-funding



scenario.  The components which would not be funded, underfunded or




delayed in the absence of co-support are marked by an asterisk (*)  in



the text.  After each Initiative is discussed, a summary is provided of



the negative impact which would occur if co-support was not forthcoming.



Figure 4-2. at the end of the chapter contains a summary of the total



nonauditory physiologic effects research program both with and without



co-support.
                                   4-10

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                               TABLE 4-2









                    ESTIMATED LEVELS OF CO-SUPPORT




                FROM OTHER AGENCIES IN THE NONAUDITORY




                 PHYSIOLOGIC EFFECTS RESEARCH CATEGORY









                                           FISCAL YEAR




                           1981	1982	1983	1984	1984






EPA Funding*                570       795       900      1000      1300




Other Agency Funding*        0        270       500      650       1000




Percent Co-Support           -        25%       35%      39%        43%
    Funding in thousands of dollars.
                                   4-11

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4.2         Detailed Descriptions of the Research Initiatives



I.                Animal Experimental Studies on tha Relationship
                  Between Noise. Elevated Blood Pressure and Other
                  Cardiovascular System Effects.

            Description and Basic Considerations.—The purposes of this

Initiative are to:  assess under controlled conditions the causal

relationship between noise exposure and selected medically significant

physiologic responses, particularly blood pressure; investigate the

associated pathophysiology; and begin to develop quantitative dose-

response relationships for selected effects.

            The primate is the animal of choice.  Animal research with

an appropriate model will permit:  detailed specification of acoustic

parameters, sophisticated and continuous monitoring of physiologic

activity, control of extraneous variables, and investigation of under-

lying mechanisms.  There will be three components under this Initiative.



Component I.   Systematic Replications and Methodologic Refinements.

            Through 1980, the purpose of the University of Miami project

has been to assess the feasibility of chronic exposure work using primates,

and to determine whether such exposures to environmental levels produce

sustained alterations in blood pressure and heart rate.  Having accom-

plished these goals,  this project will be expanded to provide necessary

replications of the rather dramatic findings of the study,  and to begin

to examine the cardiovascular dynamics involved, and associated biochemi-

cal changes.
                                4-12

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            Other animal research will be initiated in 1981 aimed at:




            (a)   Providing independent and systematic replications of




                  the University of Miami findings,




            (b)   Determining the most suitable experimental paradigms




                  (e.g., shorter duration designs, nonchair restrained




                  animals),




            (c)   Examining the suitability of other primate species.








            Funding for Component I.—Fiscal Years 1981 and 1982:




$290K/year.








            Expected Results.—By the end of Component I, EPA should




have compiled a substantial body of animal data showing a relationship




between noise exposure and alterations in blood pressure and other




cardiovascular parameters.  The physiological and biochemical mechanisms




and processes involved in these effects will be better understood.




Finally, EPA will have developed sophisticated and streamlined experimen-




tal paradigms using the most appropriate, available primate species.








*Component II.  Investigations of Acoustic and Nonacoustic Factors.




            In the second Component of animal experimental studies, it




will be appropriate to begin to focus on the development of quantitative




dose-response criteria using animal models.   Very detailed work will be
                                   4-13

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done on the relationship between various acoustic parameters and cardio-




vascular effects.  Examples of parameters to be studied include noise




level, frequency content, duration and temporal pattern (e.g.,




intermittency).




            This research will also examine the extent to which the




effects are mediated by various nonacoustic factors.  Interest here is




with the context in which the noise occurs.  Using well established




conditioning and scheduling techniques, it is possible to manipulate




important contextual variables, such as the "aversiveness" and




"controllability" of the noise.




            Funding.—Fiscal Years 1983-1987:  $200K (1983), $200K




(1984), and $250K (1985).








            Expected Results.—These parametric studies will begin to



provide the type of information necessary to derive tentative dose-




response relationships appropriate to the animal models, providing




information on how much noise and what kind of noise is associated with




how much effect.  Information will also be obtained on the extent to




which nonacoustic factors influence the relationship.








*Component III.  Investigations of Differences in Susceptibility.




            In the third Component of animal experimental studies,




attention will be directed to attempting to determine individual dif-




ferences in susceptibility to the cardiovascular effects of noise.  Work




will proceed using various kinds of animals:  animals bred for
                                   4-14

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hypertension; animals whose systems have been compromised through surgi-




cal intervention, the infusion of hormones, or through pharmacological




means; animals displaying other cardiovascular risk factors; animals




preconditioned to be hyperreactive to noise and other stressors; and




older animals, young animals and infants.




            Funding.—Fiscal Years 1983-1988: $100K/year.








            Expected Results.—This research will attempt to determine




whether there are certain factors which predispose or place the organism




at greater risk for cardiovascular effects, and whether noise exacerbates




pre-existing health conditions.




            Without needed co-support, $100K less would be available in




Fiscal Years 1983 through 1985 for supporting animal experimental work.




This represents a significant decrease (approximately 30 percent) in




the funding of this Initiative.  This decrease would necessitate pro-




longing the required work beyond the dates specified, or even not sup-




porting any research on individual differences in susceptibility during




the Five-Year Plan period.
                                4-15

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II.               Epidemiclogic Studies on the Relationship Between
                  Long-Term Noise Exposure and Adverse Cardiovascular
                  Effects
            Description and Basic Considerations. — The purposes of

these studies are:  to provide valid epidemiologic data on the relation-

ship of long-term noise exposure and adverse cardiovascular effects,

particularly hypertension; to determine the extent to which a causal

relationship exists between noise and cardiovascular effects; and to

obtain data useful in deriving criteria for the cardiovascular effects

of noise.  There will be three components within this Initiative.



Component I.  Retrospective Analysis.

            The logical first step will be to demonstrate the existence

of an association by providing a more systematic and careful replication

of the existing epidemiologic findings.  Taking advantage of a target of

opportunity, the attempt will be made to retrospectively analyze the

data from existing cardiovascular data bases.

            Funding.—Fiscal Years 1981 and 1982:  $100K/year.



            Expected Results.—Systematic replication of Eastern European

research will have been done.
                                4-16

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^Component II.  Prospective Analysis.




            Phase I - Small Scale Prospective Study




                  A relatively small, well-controlled prospective study




will be initiated in 1982.  It is anticipated that the study will be




conducted in a work setting and involve some type of intervention scenario.




An attempt will be made to find groups equivalent with respect to all




the important variables affecting the outcome measures except noise.




Detailed noise measurements will be made of the current environment and




these will have to be repeated on a regular basis throughout the study.




Dosimeters will be used to determine individual noise exposures.  As a




minimum, the project will include unbiased multiple measures of blood




pressure, electrocardiograms (perhaps some type of continuous monitoring),




assessment of hormonal responses to noise, standard blood chemistry, and




chest x-rays.  Emphasis will be placed on those individuals at high




risk.  Detailed medical histories and noise exposure histories will be




obtained as well as symptom checklists and demographic, socioeconomic,




behavioral and physiologic indicators.  The data collection will span a




period of approximately 3 years.




            Funding.—Fiscal Years 1982-1984:   $400K (1982), $500K




(1983), $600K (1984).









            Expected Results.—The prospective study will provide a test




of the causal relationship between noise and cardiovascular problems.
                                   4-17

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            Phase II - Addition of Noise to Ongoing NIH Cardiovascular
                       Research

                  The prospective study will be useful in determining

the extent to which a causal relationship exists between noise and

hypertension and other cardiovascular problems.  If promising results

are obtained, an attempt will be made to include actual noise exposure

as a factor in ongoing and/or planned large-scale NIH longitudinal

cardiovascular research.  It is only through such research that the

contribution of noise relative to other risk factors can be assessed in

a sample large enough for generalization.  Such an effort would contri-

bute greatly to the development of valid dose-response criteria.

            Funding.—Fiscal Years 1985-?:  $500K/year.



            Expected Results.—The addition of noise to large-scale NIH

research will provide a sample large enough for generalization.



*Component III.  Investigation of Special Sub-Populations.

            Phase I - Blood Pressure in Children

                  Tentative data concerning elevations in blood pressure

and a fairly extensive literature on cognitive development suggest that

children may constitute a population susceptible to the nonauditory

effects of noise.  In the biomedical research community there is also

concern about the prevalence of essential hypertension in children and

the predictive value of childhood blood pressure labilities and elevations,

A basic question concerns the relative contributions of genetic and
                                   4-18

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environmental factors to the development of blood pressure elevations in




children.  In 1*983, an initial investigation will be undertaken to




examine the role of noise in one of several ways:  1) through an expan-




sion of the Fels Research Institute longitudinal hearing loss study,




2) by adding noise to one of the several ongoing childhood blood pressure




studied sponsored by NIH, or 3) by including blood pressure as a compo-1




nent in planned research on the effects of noise on cognitive and language




development and school performance.




            Funding.—Fiscal Years 1983-1985:  $150K (1983), $150K (1984),




$150K (1985).








            Expected Results.—This research will begin to determine




whether young children are particularly susceptible to the cardiovascular




effects of noise.








            without co-supportf the completion of the Phase I -




Small Scale Prospective Investigation would be delayed until 1985, thus




preventing the Phase II - NIH Add On from beginning during the five-year




period of the Plan.  Absence of co-support would necessitate funding of




the Phase I study through four years instead of three.   Without co-




support, the Blood Pressure in Children component will  be delayed two




years and would not be completed in 1985.
                                   4-19

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III.              Human Clinical Studies of Cardiovascular and
                  Neuroendocrine Responses to Noise



            Description and Basic Considerations.—The purposes of this

Initiative are to provide controlled examination of the relationship of

noise exposure to medically significant nonauditory physiologic effects

in humans, and to provide data on individual differences in susceptibi-

lity and the exacerbating effects of noise.  Although it is difficult to

do chronic exposure research with human subjects, there are important

questions which can be addressed through human field and laboratory

studies.  One of the advantages of this approach is that it permits a

combining of nonauditory physiologic effects research with research in

sleep, behavioral and performance effects.

            The program will involve a series of multi-day and/or multi-

session experiments directed at examining cardiovascular and neuroendo-

crine response to noise.   The time course of response, recovery, and

adaptation will be examined using both phasic and tonic response measures.

Two components are planned under this Initiative.



^Component I.  Investigations of Acoustic and Nonacoustic Factors.

            Systematic attention will be given to the role of acoustic

factors like level,  frequency spectrum, and temporal pattern.

Investigations will be carried out to assess the role of important
  The terms phasic and tonic, respectively, are used here to refer to
  measures which are rapidly changing versus those which are relatively
  enduring and long-lasting.
                                   4-20

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nonacoustic or contextual factors like controllability, aversiveness




(annoyance level), meaning/familiarity, contingencies, and task load.








            Funding.—Fiscal Years 1981 to 1985:  $100K (1981), $150K (1982),




$150K (1983), $150K (1984) and $200K (1985).








*Component II.  Investigations of Differences in Susceptibility.




            Experiments will be conducted using several relevant sub-




populations of subjects such as nonnotensives, hypertensives, Type A




coronary prone personalities, and the chronically noise exposed.  These




studies will be carried out using either residential or mobile laboratories.








            Funding.—Fiscal Years 1981 to 1985:  $80K (1981), $125K (1982),




$150K (1983), $150K (1984), $150K (1985).








            Relation to Ongoing Non-EPA Studies.—The NIH and VA studies




mentioned in Section 4.1.4 are scheduled to end in the relatively near




future.  Thus their results could contribute to the design of the planned




EPA research under this Initiative.




            Expected Results.—




            1.    Provide data on the time course of response, rate of




                  recovery, and adaptation of physiological responses to




                  noise.








            2.    Assess individual differences in these responses.
                                   4-21

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            3.    Assess the role of various acoustic and nonacoustic




                  factors in influencing these responses.








            4.    Provide human data to complement and verify the findings




                  obtained in the primate research.








            Lack of co-support would amount to a reduction of over




35 percent in the support for human clinical research during the Fiscal



Years 1983 through 1985.  This work, which will provide the necessary




complement to the animal and epidemiologic data, would be delayed well




beyond the projected 1985 completion date.
                                4-22

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IV.              * Nonauditory Physiologic Effects Initiatives Other Than
                  Cardiovascular Effects
            Description and Basic Considerations.—The purposes of this

Initiative are:  to evaluate the state of knowledge with respect to the

nonauditory physiologic effects of noise other than cardiovascular

effects; to establish research priorities among those areas on the basis

of health impact and feasibility; and to outline research plans in each

of these categories.

            Under current funding level estimates, no nonauditory

physiological effects Initiatives other than those pertaining to cardio-

vascular effects will be possible in Fiscal Years 1981 and 1982.  With

the needed co-support from other agencies, work will be started in 1983

under this important Initiative.

            The program as outlined would begin with a series of litera-

ture reviews, symposia, and research planning activities.  Based on the

results of these appraisals, research into these areas will begin in

1984 and expand greatly in 1985.  Although it is not possible to discuss

specific research components in detail,  the following are possibilities:

            o     Descriptive and correlational field studies of the

                  relationship of noise to health symptoms, complaints

                  and behaviors.



            o     Determine whether living and/or working in high noise

                  environments is associated with:   (1)  difficult
                                   4-23

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                  pregnancies, (2) births with complications, (3) low




                  birth weights, (4) birth defects, (5) and other




                  reproductive/sexual dysfunctions.








            o     Investigations of the effects of noise on the physical




                  growth, development and general health of children.




                  (Evidence suggests that children may be a susceptible



                  population with respect to noise effects).








            o     Since noise seldom occurs by itself, laboratory and




                  field studies are needed on the interaction of noise




                  with other stressors and environmental hazards.








            Funding.—Fiscal Years 1983-1985:  $100K (1983), $300K (1984),



and $950K (1985).








            Expected Results.—




            By 1985, EPA will have determined those nonauditory physio-



logic effects other than the cardiovascular chat are considered to be




most important in terms of health consequences.   Detailed research plans



will have been developed in these areas and comprehensive research



programs will be underway in the most important areas.
                                   4-24

-------
            Without co-support, very little research would be initiated




during the five-year period concerning other ncnauditory physiologic




effects.  The appraisal would be delayed and funding levels for research




reduced drastically from almost $1 million in 1985 to $300K.









4.3         Time and Funding of Research Initiatives




            See Figure 4-2.








4.4         Monitoring and Coordination




            Liaison will be maintained through the Federal Interagency




Health Effects Advisory Group with the other agencies interested in




physiologic research.  The foreign literature will be closely monitored.








4.5         Research Initiatives that Will Not Be Undertaken by EPA




            EPA is planning to initiate limited work in all of the




Research Initiatives it believes are important in the cardiovascular




area.  The extent to which this can be adequately accomplished depends




on co-support by other Federal agencies.




            EPA believes that the type of multi-faceted program needed




to study these effects will be underway by 1983.   However, all the




information needed for dose-response criteria will not be obtained by




1985, but EFA should be in a good position from which to decide the




direction and extent of additional research.   With a sizable effort in




the cardiovascular area, very little attention will be given to the




other nonauditory physiologic effects prior to 1984.   Consequently,
                                4-25

-------
there are many important topics that will not receive adequate attention;




yet they may have severe health consequences.
                                4-26

-------
RESEARCH INITIATIVES
I. Animal experimental studies:
o Systematic replications and methodological refinements
o Investigations of acoustic and nonacoustic factors
o Investigations of differences in susceptibility
II. Epldemiologic studies:
o Retrospective analysis
o Prospective analysis
Phase I - Small scale prospective study
Phase II - Mill Add-on
o Investigations of special sub-populations - Blood
pressure in children


Fiscal y
1981
$290K
$290K
$100K
$100K

1981
ear fundir
1982
$290K
$290K


$100K
$100K
$130K
$400K

1982
ig*
1983
$100K
$200K
$100K
$100K
$500K
$550K
$150K

1983
1984
$100K
$200K
$100K
$100K
$500K
$6"OOK
$150K

1984
1985
$150K
$250K
$100K
$100K
$400K
0
$500K
$150K
$150K

1985
FIGURE 4-1.  TEMINC AND EPA FUNDING FOR NONAUDITORY PHYSIOLOGIC EFFECTS

-------
RESEARCH INITIATIVES
III. Human clinical studies:
o Investigations of acoustic and nonacoustic factors
o Investigations of differences in susceptibility
IV. Other nonauditory physiologic effects:
o Scientific appraisals
o Selected studies
TOTALS
Fiscal yi
1981
$100K
$100K
$30K
$80K
$ 570K
$ 570K

1981
sar fund in
1982
$150K
$150K
$125K
$125K
$ 795K
$1065K

1982
g
1983
$100K
$150K
$100K
$150K
$100K
$ 900K
$UOOK

1983
1984
$100K
$150K
$100K
$150K
$100K
$300K
$1000K
$1650K

1984
1985
$100K
$200K
$100K
$150K
$300K
$950K
$1300K
$2300K

1985
FIGURE 4-].  TIMING AND EPA FUNDING FOR NONAUDITORY PHYSIOLOGIC EFFECTS (cont.)

-------
to
                      1931
19! 2
                                           FIGURE 4-2   FUNDING FOR NONAUDITORY PHYSIOLOGIC
                                                        RESEARCH,  WETH AND WITHOUT CO-SUPPORT

-------
5.  RESEARCH PLAN FOR




    SLEEP DISTURBANCE

-------
                           TABLE OF CONTENTS
Contents                                                           Page
5.1   Rationale  for Selecting Specific Research                    5-  1
      Initiatives

      5.1.1     What is Known                                      5-  1

      5.1.2     What is Not Known                                  5-  3

      5.1.3     EPA Priorities                                     5-  5

      5.1.4     Current Research Activities                        5-  5

      5.1.5     Position on the Research Continuum                 5-  6

      5.1.6     List of Planned EPA Research  Initiatives           5-  6
                for the Five-Year Period

5.2   Detailed Descriptions of the Research Initiatives            5-  8

                  I.  Relationship between field  and               5-  8
                      laboratory data on sleep
                      disturbance by noise

                 II.  Health consequences of  noise-                5-  9
                      disturbed sleep

                III.  Acoustic parameters related to               5-11
                      sleep disturbance

                 IV.  Susceptibility of sensitive                  5-12
                      populations to sleep disturbance
                      by noise

                  V.  Adaptation to sleep disturbance              5-13
                      by noise

5.3   Timing and Funding of the Research Initiatives               5-13

5.4   Monitoring and Coordination                                  5-13

5.5   Research Initiatives That Will Not Be Undertaken           .  5-15
      by EPA
                                 5-ii

-------
                 5.  RESEARCH PLAN FOR SLEEP DISTURBANCE



             The long-term EPA objective for research on sleep disturbance

is to determine and quantify effects of noise on sleep,  and its implications

for general health and performance.



5.1          Rationale for Selecting Specific Research Initiatives



5.1.1        What is Known

             About the Effects of Noise on Sleep Itself.—Everyone has

experienced disturbances of sleep attributable to noise.  The most

obvious forms of disturbance are prolonging of the time initially

needed to fall asleep, awakening once asleep, and interference with

returning to sleep once awakened.  Noise may also affect sleep in less

apparent ways, that is by inducing shifts from deeper to lighter sleep

stages, as measured electrophysiologically.*  In the aggregate, repeated

noise intrusions during sleep may influence the total time spent in

sleep states of different depths.

             People vary greatly from one another in their susceptibility

to sleep disturbance by noise exposure.  Individuals also vary in

susceptibility from time to time and from situation to situation.   The

degree of familiarity with a noise is clearly a major determinant of
  The stages of sleep are measured by electroencephalograms (EEC).   The
  EEC is a visual picture of brain wave patterns that have meaning  and
  organization.
                                 5-1

-------
sleep disturbance, especially  awakening.   Other factors,  such as the




meaningfulness of noise  intrusions,  their abruptness  of onset,  and their




expectedness, duration,  and  intrusiveness seem to influence the




likelihood of sleep disturbance.   Also,  the  subject's age,  sex, and




state of health are known  to play  a  role.  For example, susceptibility




to sleep disturbance  increases  with  age  from childhood through  old age.




             A general relationship  between  increasing noise exposure




levels and increasing likelihood of  sleep disturbance is  nonetheless




well established.  Based on  empirical  evidence,  preliminary criteria




have been established for  the  likelihood  of  noise disrupting sleep




(causing a change in  sleep stage)  and  for awakening  induced by  noise.




             About the Effects  of  Sleep Disturbance  on Health and




Performance.—As is the  case with  other  forms  of physiological  response,




interpretation of the health effects of noise  exposure on sleep is




difficult; presently  there is  no unequivocal evidence that  common




forms of sleep disturbance are  hazardous  to  health.   However there are




indications in the research  literature  that  the  quantity  of sleep is less




important than its quality as measured by the  organization  of sleep depth




stages.  Sleep quality as so defined has  been  found  in some of  the




research to affect certain subjective, physiological  and  performance




measures.  This is important in studying  noise  effects because  awakening




per se seems to habituate while effects on sleep quality  do not.   While




the results here are  tenuous,  in clinical practice,  the medical community




has long recognized the  requirement  for sleep  and peaceful  rest for




recuperation from illness.




                                 5-2

-------
             People clearly feel a  loss  of well-being  from sleep deprivation.




The major subjective consequences of noise-induced  sleep  disturbance that




have been reported are fatigue, irritability,  drowsiness,  difficulty in work




performance, and a diminishing  in overall feeling of well-being.  According




to EPA's Urban Noise Survey, of those  persons  who said they had  been




bothered by noise in their neighborhoods, 60 percent cited sleep disturbance




as one of the most common and annoying aspects  of the  problem.   More serious




health consequences may be associated  with chronic  sleep  disturbance.








5.1.1        What is Not Known




             About the Effects  of Noise  on Sleep Itself.—While  forming




an adequate basis for Federal regulatory purposes,  a   major difficulty




with available information about noise-induced  sleep interference is that




much of it is derived from laboratory  rather than field study.   It is




possible that some of the effects of noise on  sleep demonstrated under




laboratory conditions may be different in familiar  residential  settings.




Thus, it is not known how much  of present understanding is artifactual




in nature.




             Absence of information about the  degree to which noise




degrades sleep quality is also  a major impediment to assessment  of the




effects of noise exposure on sleep.  Since it  is known that people vary




greatly in sleep patterns from  time to time and from individual  to




individual, it is not at all clear  that  sleep  disturbance  produced by




noise exposure has serious consequences.  Whether habituation or




adaptation to noise takes place during sleep is also a controversial





                                 5-3

-------
matter.  Studies suggest  that habituation  can occur on the behavioral




awakening level without occurring  on  the physiological level of sleep




depth.




             It is not known how noises of different acoustic charac-




teristics affect sleep.   Criteria  developed on the  basis  of one noise




source may have limited validity when applied to  another.   It has been




suggested that response patterns of people exposed  to traffic noise are




different from responses  found  due to noise from  other sources.  Further,




the degree of influence of nonacoustic  factors (such as age and state of




health) is not known<




             About the Effects  of  Sleep Disturbance on Health and




Performance.—There is virtually no information on  the seriousness of




chronic deprivation of rather small amounts of sleep per  night, nor of




the shift of sleep from one electrophysiologically  measured state to




another.  Similarly, people awaken for a number of  reasons during the




night, not all of which are noise-related.   Further,  it is not known




whether additional awakenings and/or  changes  in sleep depth due to noise




are of any consequence from a health  standpoint.  Research on the health




and performance consequences of sleep disturbance is  only  just beginning.




A number of potential measures  of  health and  performance  have not yet been




systematically explored or applied to sleep questions.  Consequently, the




ultimate seriousness of chronic sleep disturbance due to  noise has yet to



be determined.
                                 5-4

-------
5.1.3        EPA Priorities




             A major research need  is  the  determination  of the  effects




of acoustic and nonacoustic variables  on sleep  quality.   Also,  meaning-




ful response measures of sleep disturbance to aid  in  conducting research




should be developed.  More information  is  needed about sleep  patterns  in




residential rather  than laboratory  settings, and about the incidence




of chronic sleep disturbance in the United States,  especially as  it  is




attributable to different noise sources.   EPA also  needs  to determine




the degree to tfiich habituation and/or  sensitization  to  noise exposure




occurs.  If people  adapt to noise disturbance of sleep,  the biological




costs of the adaptation need to be  defined and  quantified,  both in the




short- and long-term.




             It is  necessary to define  sleep quality  both physiologically




and behaviorally.   Further, it is important  to  study  physiological




correlates of sleep disturbance, and  to examine any implications  of




chronic noise-induced sleep disturbance on general  health and performance.




It is also necessary to identify any  population subgroups that  may be




especially susceptible to noise-induced sleep disturbance and to  determine



the consequences of such disturbance.








5.1.4        Current Research Activities




             There  is only limited  Federal work to  date  on these  particular




topics.  EPA has not sponsored any  research  to  date.  Over the  last  five




years expenditures  by other Federal agencies for sleep-related  noise studies




have totaled only a little over $350,000,  and have  covered only some of the





                                 5-5

-------
subtopics of sleep  research of  interest  to  EPA.

             o  NASA presently  has a  study  on  the  effects  of aircraft noise

on sleep, scheduled to end soon.

             o  The Navy has  an on going  program of sleep  research which

may be of some assistance  to  EPA in planning  the sleep  research program.

             o  The Public Health Service  is  planning  a program of research

related  to sleep and sleeping pill usage, but  details  which may be important

to EPA's mission have not been  specified  as yet.

             o  There may be  a  useful  data  base  available  from a set of

studies  sponsored by the European Economic  Commission  (EEC),  now in

their third of four years of  study.  The  four  "in-home" studies from the UK,

Netherlands, France and West  Germany are  investigating  the effects of

noise disturbance of sleep on general  health  and performance.



5.1.5        Position on the Research  Continuum

             As can be seen in  Table 5-1, preliminary  criteria have

been established based on how noise disturbs  sleep itself.   However,

health and performance effects  of noise-disturbed  sleep are among the

least understood effects of noise, owing  to the  inability  to define the

functional value of sleep, among other factors.



5.1.6        List of Planned EPA Research Initiatives  for  the  Five-Year
             Period

             After  reviewing  the status of  noise-induced sleep disturbance

research, EPA program needs and priorities, and  the planned research


                                 5-6

-------
                                TABLE 5-1

          POSITION ON THE RESEARCH CONTINUUM - SLEEP DISTURBANCE
     Research Continuum



1.  Demonstrate existence of an
    association

2.  Demonstrate basic cause-effect
    relationship

         A.  Animals

         B.  Humans

3.  Investigate physiologic mechanisms

4.  Investigate intervening factors.
    Improve cause-effect relationship

         A.  Acoustic

         B.  Nonacoustic

5.  Quantify dose-response relationship

6.  Refinement and special populations
   Current State of Knowledge

Adequate   Marginal  Inadequate

    1          2
              y

              y
                         x


                         X
i
 The rating "y" refers to the status of research on the short-term
 effects of noise on sleep itself.
2
 The rating "x" refers to the status of research on the health and
 performance consequence of sleep disturbance.
                                 5-7

-------
  activities of other Federal agencies, the following Research Initiatives

  for EPA funding have been selected for the next five years.   They are

  not listed in order of priority.
  I.   Relationship between field and laboratory data on sleep disturbance
       by noise

 II.   Health consequences of noise-disturbed sleep

III.   Acoustic parameters related to sleep disturbance

 IV.   Susceptibility of sensitive populations to sleep disturbance by
       noise

  V.   Adaptation to sleep disturbance by noise
               Their selection,  and the selection of  their funding  levels,

  are based on the assumption that there will  be  no co-support  from

  other agencies in the sleep category because of differing agency  missions.

  The likelihood exists however,  that  EPA may  be  able to  derive  some benefit

  from studies planned  by other  agencies.



  5.2          Detailed Descriptions of the Research  Initiatives



  I.            Relationship Between Field  and  Laboratory  Data on Sleep
               Disturbance by Noise

               Description and Basic Considerations.—Present criteria

  proposed  to  assess  sleep quality (sleep  disturbance, or shifts in sleep

  depth,  and awakening)  are based  on the sleep of  subjects  measured under

  laboratory study conditions; there is  a  need  to  relate  sleep as measured

  in  the  laboratory to  sleep  at home.  Further, reports of  subjective


                                   5-8

-------
sleep quality as reported by people sleeping  at home have  never  been




fully validated or related to objective  sleep measures.  This  Initiative,




therefore, is designed to meet short-term programmatic objectives  by




improving the criteria now used,  that is, by  comparing the influence  of




noise upon sleep in both the laboratory  and the home.  This  information




will also be used in other Research Initiatives dealing  with  the longer-




term health and performance impact of noise-disturbed sleep.   This




research will be conducted during Fiscal Years 1981 and  1982  at  a  cost




of $LOOK per year.




             Expected Results.—Correction factors or new  criteria are




expected which, when applied to laboratory data, may be  used  to  predict  the




magnitude of noise-related sleep  disturbance  in the home environment.




Additional information will be needed to relate subjective sleep quality




evaluations to objective sleep measures.








II.          Health Consequences  of Noise-Disturbed Sleep




             Description and Basic Considerations.—This Initiative is




designed to objectively define and quantify the impact of  noise-disturbed




sleep on general health and performance.  It  will consist  of  two related




components.




             Primate Studies;




             Under controlled conditions, the first component  will  use




animals (primates) to study the biochemical and electrophysiological




parameters related to sleep disturbance, health and performance.   The




initial years of primate studies  (Fiscal Year 1981:  $100K; Fiscal  Year





                                 5-9

-------
1982:   $150K)  will  explore  physiological parameters and protocols best




suited  to  related human  research.




             Human  Studies;




             The second  component,  human studies,  will be conducted for




the most part  in parallel with  the  animal work and will be based on the




results of  the  initial primate  work.   These  studies will investigate




parameters  such as  drug  consumption,  absenteeism,  medical records,




biochemical and performance measures.   Research in this component will




begin in Fiscal Year  1983,  interrelating through Fiscal Year 1985 with



the primate research.




             Funding  for the Health Consequences Ini^ative (both human




and animal) is projected at $250K in  1983, $350K in 1984, and $450K in




1985.  Approximately  $200K  of the funding in 1985  will be assigned  to




studying how the primate data can be  generalized and applied to humans.




             Relation to Ongoing Non-EPA Research.—In designing the




Health Consequences Initiative  it was  assumed that  the series of studies




being sponsored by Commission of the  European Communities (CEC) will




provide useful information  on which to base  EPA research.  EPA will be




in continuing communication with the  CEC investigators.




             Expected Results.—




             1.  An objective preliminary definition and measurement




of the value of sleep for health and  performance,  and the ability to



measure the deficits  due to sleep disturbance by noise.




             2.  A quantified relationship between  noise-disturbed  sleep




and consumption of drugs such as tranquilizers,  sleeping pills, and



stimulants.




                                 5-10

-------
             3.  Quantified relationships between noise-disturbed sleep




and other health and performance measures to be specified in the course of




the research (after pilot work) will probably not be forthcoming within




the five-year period because of extreme complexity and large gaps existing




in our understanding of sleep.




             4.  Validation of laboratory-home correction factor derived




from Initiative I.








III.         Acoustic Parameters Related to Sleep Disturbance




             Description and Basic Considerations.—The basic thrust of




this Initiative will assess how different types of noise (as from




different noise sources) differentially affect sleep.   Existing criteria




are based mainly on responses to aircraft overflights.  Their specific




application to sources such as trucks,  buses, automobiles,  rapid transit




vehicles, railyards, construction equipment, household appliances,  garden




and shop tools should be studied.  Studies will specifically investigate




the effects of rise time, frequency spectra, duration, vibration concomitant




with noBflje, impulsiveness,  intermittency, and intrusiveness over background




levels.




             This Initiative is to begin in Fiscal Year 1982, and it




will continue through Fiscal Year 1985  at funding levels of $60K (1982),




$150K (1983) $150K (1984) and $50K (1985).




             Relation to Ongoing Son-EPA Research.—NASA is investigating




similar types of questions  for aircraft noise.




             Expected Results.—A family of sleep disturbance criteria




for different noise characteristics and sources is expected.






                                 5-11

-------
             The information will allow quantification  of benefits  of

noise control action, and also contribute  to  the Health Consequences

Initiative (II).  The correction factor developed  from  Initiative II,

assessing differences between home and laboratory  studies, will be

applied.



IV.          Susceptibility of Sensitive Populations  to Sleep Disturbance
             by Noise

             Description and Basic Considerations.—Existing studies and

criteria are based mainly on the sleep of  young, healthy male students.

Susceptibility  to sleep disturbance is known  to vary  with age and other

factors (e.g.,   the elderly are highly susceptible  to  sleep disturbance).

No special criteria exist for these groups at  this  time.  This Initiative

would quantify  sleep disturbance for special populations such as  the elderly,

middle-aged people, children, the ill, and the growing  number of  night-

workers (day-sleepers).

             This Initiative is scheduled  for Fiscal  Years 1984 and 1985

and beyond, and is anticipated to extend at least  through Fiscal  Year  1987.

Budgeting will  be $100K/year for Fiscal Years 1984  and  1985.

             Relation to Ongoing Non-EPA Research.— NIH's study on  sleep

and sleeping pill usage may be considered  to address  a "special population,"

i.e.,  persons who perceive themselves as having difficulty sleeping and who

are regular users of drugs.  Potential applicability  of this work is

presently unknown.

             Expected Results.—The objective is a  family of sleep  disturbance

criteria (by noise) for people of different ages,  states of health,

                                 5-12

-------
occupations, and  lifestyles.









V.           Adaptation  to Sleep Disturbance  by  Noise




             Description and Basic Considerations.—Using  both  short-term




(behavioral and electroenc.ephalographic)  as well as other  measures




(biochemical, health and performance)  derived from previous  Initiatives,




studies will determine degrees of adaptation,  habituation  and/or




sensitization to  noise disturbance over  time  (in terms  of  years  of  chronic



exposure).




             Studies are planned to be conducted in Fiscal Years 1985  and




1986, funded at $150R per year.




             Expected Results.—Objectives are revised  criteria  for sleep




disturbance and awakening, and preliminary criteria for the  long-term




effects of noise-disturbed sleep on general health and  performance.








5.3          Timing and EPA Funding for  the Research Initiative.




             See Figure 5-1, on the following  page.








5.4          Monitoring and Coordination




             EPA staff will maintain liaison  with  other agencies  and




groups involved in the sleep area.  Additional liaison  and coordination




is anticipated to take place through the National Academy  of Sciences.
                                 5-13

-------
RESEARCH INITIATIVES
I. Relationship between field and laboratory data on sleep
disturbance by noise.
II. Health consequences of noise-disturbed sleep
o Primate studies
o Human studies and continuation of primate
o Application of primate findings to humans
III. Acoustic parameters related to sleep
IV. Susceptibility of sensitive populations to sleep
disturbance by noise
V. Adaptation to sleep disturbance by noise
TOTALS
Fiscal y<
1981
$100K
$100K
$200K

1981
aar fund In
1982
$100K
$150K

$50K
$300K

1982
g
1983
$250K
$150K
$400K

1983
1984
$350K

$150K
$100K
$600K

1984
1985
$250K
$200K
$50K
$100K
$150K
$750K

1985




FIGURE 5-1.   TIMING AND EPA FUNDING FOR SLEEP-DISTURBANCE

-------
5.5          Research Initiatives That Will Not Be Undertaken  by  EPA




             The identified funding levels will not  permit  the type of




comprehensive investigation necessary to meet  the  full  objectives  of




the described Initiatives.  In addition, work  under  some  Initiatives  which




would otherwise be completed in a year or two, is being prolonged  over a




number of years or being delayed to later years to meet the  funding




requirements.
                                   5-15

-------
6.  RESEARCH PLAN FOR




    INDIVIDUAL AND COMMUNITY RESPONSE

-------
                      TABLE OF CONTENTS
Contents
6.1   Rationale for Selecting Specific Research                   6- 1
      Initiatives

      6.1.1     What is Known                                     6- 1

      6.1.2     What is Not Known                                 6- J

      6.1.3     EPA Priorities                                    6- 4

      6.1.4     Current Research Activities                       6- 5

      6.1.5     Position on the Research Continuum                6- 7

      6.1.6     List of Planned EPA Research Initiatives          6- 7
                for the Five-Year Period

6.2   Detailed Descriptions of the Research Initiatives           6- 9

                 I.    Determination of the magnitude of          6- 9
                       community and individual response
                       attributable to specific source
                       of noise.

                II.    Determination of the relationship          6-12
                       between specific acoustic
                       attributes and the magnitude of
                       individual/group response to noise.

6.3   Timing and Funding of the Research Initiatives              6-15

6.4   Monitoring and Coordination                                 6-15

6.5   Research Initiatives That Will Not Be Undertaken            g_17
      by EPA
                                  6-ii

-------
        6.  RESEARCH PLAN FOR INDIVIDUAL AND COMMUNITY RESPONSE








             The long-term EPA objective for research in this category




is to determine and quantify subjective reactions of individuals and




communities to different noise environments and sources,  and to in-




vestigate mediating factors.




             For purposes of brevity,  this category will be referred to




as "community response" in this chapter.








6.1          Rationale for Selecting Specific Research Initiatives








6.1.1        What is Known




             Information is available about individual and community




response to commonly occurring forms of noise exposure.   The major




physical determinants of both individual and community annoyance due




to noise are understood in fair depth.  For example, most of the




variability in individual judgments of annoyance associated with noise




can be accounted for under laboratory conditions by a number of objective




physical measurement procedures.




             Psychoacoustic research in the last two decades has refined




the long-known relationship between the frequency sensitivity of human




hearing and annoyance judgments.   Scales of varying complexity,  some




directly readable from simple instrumentation, others requiring complex




computations, are commonly used to predict the annoyance of a great




many noise sources.  The combined effects of pure tones and duration of






                                 6-1

-------
   sounds, among other factors, are known to influence annoyance reactions




   to noise, but research has not yielded the anticipated applications to




   the community environment.




                General relationships of overall community response to noise




   (the central tendency of large numbers or groups of individuals) have




   been derived and accepted scientifically, and are more precisely known




   than are the responses of individuals (that is,  individual variations




   are generally "averaged out" in commonly used community response



   measures).




                It is also known,  however,  that nonacoustic factors,  such




   as attitudes toward noise sources, or the particular activities disturbed,




   can affect both individual and community reactions to sound.   Thus,




   although many determinants of individual and community annoyance are




   well understood on a global level, this  general  knowledge will not yet




;   support precise situation-specific predictions of individual  or




\  community response to noise exposure.




  >v             The prevalence of annoyance due to  noise exposure throughout




   American society is known in considerable detail.   It is known,  for




   example, that annoyance due to noise exposure is not only restricted to




   neighborhoods near airports,  highways, and other major noise  sources,  but




   that exposure to levels typical of many  urban environments also produces




   widespread  annoyance.   Noises associated with automotive sources (e.g.,




   street traffic noise)  are the most universal sources of annoying noise




   exposure in urban America.




                Cumulative measures of total outdoor noise levels (for




   example, L   , the Day-Night Sound Level)  have been shown to provide a





                                   6-2

-------
useful reflection of community reaction, at least at higher exposure




levels.  Thus, the proportion of a community highly annoyed by noise




exposure can be reliably predicted from objective measures of noise




levels.  Demographic factors such as age, sex, and socioeconomic status




do not appreciably affect the accuracy of such calculations.








6.1.2        What is Not Known




             Quantitative information is still lacking on the influences




of a number of factors that may affect individual and community response




to noise exposure.  On an individual basis, considerable uncertainty




remains about the annoyance of specific noise intrusions superimposed




on the ambient noise environment.  Other unsettled issues concern the




annoyance associated with exposure to unusual and unsteady sounds.




These include sounds that may vary in level over time, sounds of very




short duration, and sounds that occur infrequently, intermittently,




or unpredictably.  The precise influence of audible pure tones in the




noise, and the presence of impulsiveness is open to question.  It is




also unclear how the immediate annoyance of noise intrusions is




affected by the nature of an individual's ongoing activities at the




time of the noise intrusion.  The manner in which people integrate or




cumulate annoyance or other adverse reactions over time is not at all




understood.



             On the community level, the effects of noise exposures at




different times of the day and seasons of the year are not fully resolved,




nor are the effects of temporary (as opposed  to long term) exposure,
                                6-3

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or numbers of discrete noise events.  Although existing criteria are




judged adequate for Federal regulatory purposes, a controversy exists




as to differences in annoyance response that may be attributable to




specific yet different sources of noise such as construction noise,




recreational noise, household noise, and so forth, as well as re-




actions that occur in special noise environments such as in transit




vehicles or work places.  Annoyance by warning signals is as yet




unexplored.




             The influence of accompanying nonacoustic variables such




as people's preconceived attitudes toward or associations with particular




sources of noise are not understood.  The questions of annoyance and




stress upon special population groups such as children, the elderly,




and the ill, as well as the variability in annoyance response between




individuals, have not been addressed.




             In addition, little is known about annoyance response to low




levels of noise (below L, =55 dB).  The variability of individual annoyance




judgments on low level noise cannot yet be accounted for on the basis




of physical (acoustical) parameters of the noise.  Yet there are environ-




mental settings such as parks, and residential, recreational and wilderness




areas, where such annoyance certainly exists.








6.1.3        EPA Priorities




             EFA program priorities require that research attention be




focused on individual and community response to a variety of special




sources of noise exposure, including construction, railroads, household




and consumer products, mass transit, noise sources in outdoor recreational





                                6-4

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areas, blast noise, and certain forms of air and ground transportation.



For example, more specific criteria for construction sites will be needed



to support planned EPA construction noise programs,  as well as to support



State and local noise control programs in their efforts to control



construction noise.



             Determining the relationship between specific attributes



of noise and the magnitude of individual or community response will



require further research attention by EPA for the same programmatic



reasons.  The specific noise attributes that need to be addressed are



noise with pronounced tonality,  fluctuating levels,  and impulsive



components;  vibration concomitant with noise; noise of varying duration,



time of occurrence, and number of discrete occurrences; and noise of



varying intrusiveness.



             The influence of a number of nonacoustic factors on indi-



vidual and community response also requires more careful study.  These



include contextual factors such as the purpose of noise emissions (e.g.,



warning signals), the perceived ability to control the noise emission


                                                                    \ f  /  i
exposure, and certain attitudes toward the sources of noise exposure/V'^r  ^


                                                                        4 ^. .i>
The response of certain, identifiable special groups within the pop-      f



ulation also deserves study.







6.1.4        Current Research Activities



             EPA has undertaken two base year activities dealing with com-



munity response to noise:  (1) A study of community reactions and attitudes



towards construction noise, and (2) an examination of response to noise



that intrudes into the environment over relatively short periods of time.





                                 6-5

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             The  first study, "Construction  Site  Noise  Attitudinal




Survey," is being conducted  in  cooperation with  the U.S.  Army Construction




Engineering Research Laboratory.  Community  response data will be acquired




around construction sites  in order  to  establish  the relationship between




construction noise and degree of  impact  on the community.




             The  other study is "Annoyance by Intrusive Sounds."  The




base-year activity will consist of  a psychoacoustic laboratory investi-




gation to determine the influence of the subjects'  degree of involvement




in various foreground tasks  on  their indicated annoyance  by  intrusive




type sounds.  This is a necessary step before the development of a




quantitative intrusiveness-type annoyance scale.




             An additional study  will  soon be undertaken  assessing human




response to the repetitive-type impulse  noise associated  with engine




brake noise.




             Over $1 million has  been  spent  by other Federal agencies




in the area of individual  and community  response  to noise over the last




three to six years.  Of the  three agencies primarily active  in this




category, NASA leads the way, with  over  eight projects  and more than




$600K devoted to  such studies.  However,  these activities concern




mainly aircraft noise.  Some of the specific Federal research activities




in the base-year  include the following:




             o  NASA study of the validity of the 10 dB night-time




                weighting  penalty applied to aircraft noise;




             o  NBS (National Bureau of  Standards)  investigation of




                the human  response  to  time-varying  traffic noise;




             o  An Air Force study  assessing the  impact of their




                aircraft noise  activities.




                                  6-6

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6.1.5        Position on the Research Continuum

             As indicated in Table 6-1, preliminary criteria exist for

quantifying the relationship between general community annoyance re-

sponse and higher level noise exposures.  However, little is known

about the effect of lower level exposures, intervening factors, and

effects on special populations.



6.1.6        List of Planned EPA Research Initiatives for the 5-Year
             Period

             After reviewing the status of community and individual

response research, EPA program needs and priorities,  and the planned

activities of other Federal agencies, the following major Research

Initiatives have been selected for EPA funding over the next five years.

             I.  Determination of the magnitude of community and
                 individual response attributable to specific
                 sources of noise.

            II.  Determination of the relationship between specific
                 acoustic attributes and the magnitude of individual/
                 group response to noise.

The assumptions made selecting these Initiatives are as follows:

             1.  Specific components within the Initiatives can only be

identified for Fiscal Years 1981-82.  Since each Initiative and its

components undertaken during the five-year period have a direct pro-

grammatic application,  only during the first two years of this Plan

can specific components be identified based on defined program needs

in the Fiscal Year 1984-85 time frame.   Research results derived from

the latter three years of the five-year period, however,  will feed into

programs beyond the Fiscal Year 1985 time frame.  Therefore,  only broad,
                                6-7

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                               TABLE  6-1

POSITION ON THE RESEARCH CONTINUUM - INDIVIDUAL AND COMMUNITY RESPONSE
      Research Continuum



1.  Demonstrate existence of an
    association

2.  Demonstrate basic cause-effect
    relationship

3.  Investigate response mechanisms

4.  Investigate intervening factors.
    Improve cause-effect relationship

    A.  Acoustic

    B.  Nonacoustic

5.  Quantify dose response relationship

6.  Refinement and special populations
  Current State of Knowledge

Adequate  Marginal  Inadequate
              x*
              X*
*A1though rated as marginal, the only parameter that has been sub-
stantially quantified and is fully usable for noise assessment purposes
is that of perceived amplitude or intensity (level).
                                 6-8

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general Initiatives are entered into Fiscal Years 1983-85, with  the

intent of narrowing the Initiatives into specific components as  de-

fined program needs become apparent.

             2.  Because of the emphasis placed on the nonauditory

physiologic effects research, only low-level funding for individual

and community response is anticipated during this five-year period.

However, it is expected that other Federal agencies,  and investigators

in other countries and in the private sector, will conduct some  re-

search in this effects category.  Although EPA will have only limited

influence on the precise direction of this research,  it is anticipated

that many of the experimental findings will be usable by EPA.   As new

program needs are defined in the next few years, funding levels  in this

category will be reevaluated.

             3.  No component within any Initiative will be completed

within this five-year time frame.   Thus, results may not yield quan-

titative relationships suitable for all conceivable applications.

             4.  The level of funding suggested will allow study of only

one or two components within any Initiative at a time.



6.2          Detailed Description of the Research Initiatives

             I.   Determination of  the magnitude of community and individual
                 response attributable to specific sources of  noise.

             Description and basic Considerations.—This Initiative consists

of two components:   a construction noise component to be started immediately,

and other components  to be started later.


                                6-9

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             Construction Noise.—The construction noise component under-




 taken  in Fiscal Year  1981 is a carryover from the previous year (Fiscal




 Year 1980).  The purpose of this research element is to acquire community




 response data  around  construction sites in order to establish the relation-




 ship between construction noise and the degree of impact upon the people




 exposed.  Special emphasis will be placed on the varying longitudinal




 aspects of the exposure and on the impact on two particular populations:




 residential and workday.  The program will include the development of




 a survey questionnaire and noise measurement protocol;  a site selection




 and respondent sampling plan;  and the implementation and analysis of




 a comprehensive attitudinal survey and noise measurement programs.




Total  funding will be $300K between Fiscal Year 1980 through 1983.




Funding will be on the order of $65K in Fiscal Year 1980,  $100K in




Fiscal Year 1981, $100K in Fiscal Year 1982,  and $35K in Fiscal Year




1983.




             Other components.—These will consist of topics most important




to EPA program needs beginning in Fiscal Year 1983.   One or more of the




following are the most likely candidates:




             a.  Railroad and  rail facility noise:   formulate criteria




directly pertaining to this  type of noise,  including yard  as well as main




line activities.




             b.  Household  and  consumer products/interior  noise:   formulate




quantitative criteria pertaining to these  special types of noises and/or




situations of exposure.
                                6-10

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             c.  Mass transit noise:  formulate criteria directly




pertaining to this type of noise, including community as well as passenger




subjective response.




             d.  Recreational areas/off-road vehicles:  formulate criteria




pertaining to this special type of noise exposure.




             e.  Aviation noise:  refine currently available criteria  for




application to special situations.




             f.  Ground transportation noise:  refine currently available




criteria for application to special situations.




             g.  Blast noise:   formulate quantitative criteria pertaining




to human subjective response to this special type of noise.




             At least two of the components listed above will be studied




from Fiscal Years 1983 through  1985 (depending on program  requirements




defined at that time) at a total cost of $590K.  Funding will be $150K




in Fiscal Year 1983,  $190K in Fiscal Year 1984, and $250K  in Fiscal Year




1985.




             Expected Results.—




             1.  The program will initially yield dose-response type




criteria (annoyance and/or other subjective evaluative attributes)




pertaining to construction noise by Fiscal Year 1983.  These criteria will




not have general application to all aspects of the construction noise




problem, but will yield criteria directly applicable to construction noise




for vihich no criteria already exist.  Information from this research will




feed into the EPA construction  site/equipment noise control programs




anticipated beyond the Fiscal Year 1984 time frame.  Also, the research



                                 6-11

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results will feed into State and local noise control programs where

interest in controlling construction noise has been expressed.

             2.  Based upon the selection of one or more additional

research components under this Initiative, this research will yield

additional dose-response criteria with respect to other sources of noise,

although these criteria will be somewhat limited for many applications.



             II.  Determination of the relationship between specific
                  acoustic attributes and the magnitude of individual/group
                  response.

             Description and Basic Considerations.—This Initiative

consists of three components.

             In the first component, undertaken in Fiscal Year 1981, human

subjective response to intrusive noise will be studied, continuing work

started in the base year (Fiscal Year 1980).  Formulation of a descriptor

or metric that pertains to noise that intrudes into the environment for

discrete periods of time (whether minutes, hours, days, or seasons) has been

identified as a high programmatic need within EPA.  Cumulative predictive

methods are not entirely adequate in a descriptive sense to account for

this type of noise.  This program will, in the initial years, consist  of

a series of laboratory psychoacoustic studies aimed at scaling the

magnitude of subjective response to various degrees of "intrusiveness"

or detectability of noise over a background.  Funding levels are  at $65K

in Fiscal Year 1980, $125K in Fiscal Year 1981, and $100K in Fiscal

Year 1982.
                                  6-12

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             A second component consists of a small program undertaken




to investigate the annoyance and detectability of warning signals within




construction settings.  This program will consist of a laboratory psycho-




acoustic study examining signal detectability of warning devices or




signals over a series of background noises typical of construction site




activity.  Funding will be at a level of $55K in Fiscal Year 1981.




             Other components to start in Fiscal Year 1982 will be




selected later on the basis of EPA1s latest assessment of its program




requirements.  Only a few components can be chosen.  Candidates include:




             a.  Intrusiveness of low-level noise:  further work is




needed to develop criteria pertaining to low-level noise (a problem noted




in many areas where background noise is already low),  or to refine work




completed up to this point (as described above in the first component).




             b.  Tonality:   a descriptor or adjustment method is needed




to ascertain adverse subjective response of people to noise which contains




perceptible tones.




             c.  Duration:   a descriptor or adjustment method is needed




to assess the influence of duration on human subjective response.




             d.  Impulsiveness:   a descriptor or adjustment method is




needed to ascertain the adverse subjective response of people to noise




which is characterized by impulsiveness.




             e.  Fluctuating noise:  a descriptor or adjustment method




is needed to ascertain adverse subjective response of  people to noise




that fluctuates in character over time.
                               6-13

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             f.  Interaction of vibration and noise:  determine the




contribution to subjective human response caused by vibration con-




comitant with noise.




             g.  Multiple events:  the manner in which people perceive




and integrate multiple events over time as reflected in their subjective




response.




             h.  Diurnal penalties:  the adjustment method currently in




use needs to be further verified with regard to magnitude of response as




a function of time of day.




             Research studies investigating selected components will be




funded at a level of $60K in Fiscal Year 1982, $150K in Fiscal Year




1983, $200K in Fiscal Year 1984, and $50K in Fiscal Year 1985.




             Expected Results.—




             1.  The program on intrusive noise will yield criteria based




on laboratory psychoacoustic studies that will be usable for limited




application in the Fiscal Year 1984 time frame.  Criteria will relate




objectively measured intrusiveness of noise to anticipated annoyance re-




actions.  EPA will evaluate the need to proceed with additional work for




Fiscal Year 1984 and beyond in this area, depending upon adequacy of the




research findings up to that time and EPA priorities reevaluated at




that time.




             2.  Results from the program pertaining to detectability of




warning signals on construction sites will yield information for use within




EPA programs in the Fiscal Year 1982 time frame and beyond.
                                6-14

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             3.  Depending upon the selection of one or more additional




research components under this Initiative,  research will yield  additional,




but preliminary,  adjustment methods or descriptors with respect to the




specific acoustic attributes,  discussed above, that may influence the




exact individual and community response to  noise.   The information derived




from this research will be useful as a basis for regulatory and certification




measurement procedures, as well as a focus  for the development  of noise




control techniques.








6.3          Timing and EPA Funding of Research Initiatives.




             See Figure 6-1.








6.4          Monitoring and Coordination




             This set of Research Initiatives will require careful




coordination, since specific components are closely tied to producing




results in accordance with the core EPA Five-Year Noise Plan.   A




second type of coordination of particular importance to this cateogry




is close liaison with researchers in other  agencies and institutions,




since EPA is also relying on the large amount of work going on  elsewhere.




Coordination will be maintained with the American National Standards




Institute's (ANSI) committees on community  noise and auditory magnitude,




as well as the Federal Interagency Noise Effects Research Panel.
                                6-15

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RESEARCH INITIATIVES
Fiscal year funding
 1981     1982      1983
                                                                                                   1984
                            1985
I.   Determination of the magnitude  of  community  and  Individual
     response attributable to specific  sources  of noise.

     o    Construction noise (a carry-over  from FY 80).

     o    Other topics which may include:   railroads; household
          and consumer products/interior noise; mass  transit;
          recreational areas/off-road vehicles; aviation noise;
          ground transportation noise;  blast  noise.
II.  Determination of the relationship  between  specific acoustic
     attributes and the magnitude  of  individual/group response.

     o    Intrusiveness (a carry-over from FY 80).
          Warning signals

          Other topics which may include:   tonal  components;
          duration;  impulsiveness;  fluctuating noise; multiple
          events; diurnal penalties.
                                                         TOTALS
 $10QK
$100K
$35K
                   S150K
                   $190K
 $180K
$100K
                                                                     or  both
                                                                     lements.
                                                                                                  ee
          $60K
          $150K
          $200K
         $250K
 §280K
$260K
 $335K
$390K
$500K
                                                                        1981
            1982
           1983
           1984
                                                                                                             1985
                        FIGURE 6-1.   TIMING AND  EPA FUNDING  FOR  COMMUNITY RESPONSE

-------
6.5          Research Initiatives that will not be Undertaken by EPA.

             The identified funding levels will not permit the type of

comprehensive investigation necessary to meet the full objectives of the

described Initiatives.  In addition,  work under some of the Initiatives

is being delayed under the funding constraints.

             The following Initiatives will not be undertaken by EPA

due to limited resources available:



     o  Identification and quantification of nonacoustic determinants
        of community and individual response to noise.

             This Initiative will not be undertaken during the five-year

period, because (a) it is more important to acquire information on the

acoustic determinants initially since they will have the most direct

programmatic applications, and (b) it is not experimentally desirable

to proceed to examine the nonacoustic parameters unless the variation

typically encountered in measuring human response to noise is minimized

to the greatest extent possible by proper quantification of the acoustic

factors.

             Components within this Initiative include:

             a.  Influence of contextual factors and attitudes on

response to noise.

             b.  Identification of nonverbal reactions to noise.

             c.  Determination of reactions to warning signals or other

noises with high meaningfulness.
                                6-17

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     o  Determination of susceptible population subgroups.




             Criteria for source specific environments and acoustic/




nonacoustic attributes are needed prior to the refinement of these




criteria to account for especially sensitive or susceptible populations.
                                6-18

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7.   RESEARCH PLAN FOR




    NOISE-INDUCED HEARING LOSS

-------
                            TABLE  OF  CONTENTS


Contents                                                           Page


7.1   Rationale for Selecting Specific Research                    7-  1
      Initiatives

      7.1.1     What is Known                                      7-  1

      7.1.2     What is Not Known                                  7-  3

      7.1.3     EPA Priorities                                     7-  5

      7.1.4     Current Research Activities                        7-  6

      7.1.5     Position on the Research Continuum                 7-  7

      7.1.6     List of Planned EPA Research Initiatives           7-  9
                for the Five-Year Period

7.2   Detailed Descriptions of the Research  Initiatives            7-10

                I.  Determine the incidence  of NIHL in             7-10
                    the United States and contribution
                    of sociocusis (nonoccupational
                    exposure), presbycusis (aging), and
                    occupational exposures.

               II.  Establish parameters of  individual             7-11
                    sensitivity to NIHL.

              III.  Refine criteria for low-level noise            7-14
                    exposure.

7.3   Timing and Funding of the Research Initiatives               7-15

7.4   Monitoring and Coordination                                  7-15

7.5   Research Initiatives That Will Not Be Undertaken             7-15
                                 7-ii

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           7.  RESEARCH PLAN FOR NOISE-INDUCED HEARING LOSS



             The long-term objective  for  research  in this  category is to

determine the extent of the problem,  causative factors,  and  associated

effects.
7.1          Rationale  for Selecting Specific  Research  Initiatives  Over
             the Five-Year Period
7.1.1        What is Known

             The prevalence of hearing  loss  among  workers  in  industry

has been recognized since the start of  the industrial  revolution.   Within

the last three decades a number of hearing loss  studies  in industry have

shown a direct relationship between hearing  loss and  the  intensity  and

duration of noise exposure.  As the intensity  and  duration of noise

exposure increases, a greater proportion of  the  sensory  cells within the

inner ear will be damaged and eventually destroyed.  This  will result in

a permanent, irreversible loss in hearing sensitivity.

             Noise-induced hearing loss (NIHL) increases most rapidly over

the first 10-15 years of noise exposure in the higher  frequencies.   Noise-

induced hearing loss has been observed  for daily noise  levels as  low as

75 dB after 10 years of exposure.  Because the loss in hearing is so

gradual, most people do not recognize the reduction in  their  hearing

sensitivity until it is too late.  Hearing loss often  causes  a complete

change in a person's social and work life. The hearing process is


                                 7-1

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 fundamental  to  the  perception  and  understanding of speech,  and persons




 with noise-induced  hearing  loss  have  great  difficulty understanding




 speech when  there is  some noise  in the  background.




             Industrial hearing  loss  studies  have  provided  a set of




 quantitative damage risk criteria.  Risk refers to the probability




 that a certain  percentage of a noise  exposed  population will suffer




 NIHL in excess  of a specified  value.  Specific noise  limits have been




 proposed for the purpose of protecting  workers'  hearing levels based on




 these criteria.  However, there  is  a  great  deal of individual variation




 in susceptibility to  hearing loss.  Industrial studies have shown a wide




 variation in hearing  levels for  worker  populations  of the same age and




 with the same occupational  noise exposure.  Animal  experiments as well




 have shown substantial variations  in  the hearing damage of  animals of the




 same species after  comparable  exposures.  There is  also some evidence that




 young animals incur more auditory  damage than predicted for older animals.




This finding has relevance  to  the  issue  of  children and NIHL.




             Some hearing surveys  in  the population have shown demo-




 graphic differences  in the  hearing  levels of  different races,  sexes,




 cultures and social groups.  Certain  people in remote areas of the world,




 who have not been exposed to the din  of  noise in our  mechanized society,




have much better hearing in comparison  to urban populations of correspond-




 ing ages.  The  only factor  that  is  known to increase  the likelihood of




a hearing loss  besides aging and disease is increased exposure to environ-




mental noise.   For  example, listening to amplified  music, shooting guns,




and motorcycle  riding are a few  of  the  common recreational  noise exposures





                                   7-2

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known to contribute  to hearing  loss.  The  auditory  effects  of environ-




mental noise exposures in  transit,  recreation  and  in the  household have




not been studied in  enough detail  to  determine their consequences  on




hearing.








7.1.2        What is Not Known




             Although generally adequate  for Federal regulatory purposes,




there remain a number of unanswered questions  concerning  the  effects




of noise on hearing.  Most of the  data  concerning  the long-term auditory




hazards of noise come from studies of continuous steady  state occupational




noise exposure.  There is a  lack of definitive information  on the  effects  of




shorter term intermittent noise exposures  which may be  less harmful to




hearing.  Most of the knowledge concerning  impulse  noise  comes  from




studies of the effects of gunfire  noise,  yet millions of  Americans are




exposed to impulse/impact noise on the  job.  Existing criteria  may not




fully account for time varying noise exposures.  Neither  do  these




criteria account for what may well be additive effects  of concurrent




impulse noise and steady state noise exposure.




             Much of the present occupational  hearing loss  data base is




contaminated by nonoccupational noise exposures in  the military,  trans-




portation, hobbies and recreational activities.  Furthermore,  there is




a marked deficiency  in our knowledge of the incidence of  NIHL in the




United States outside of the workplace.  Very  little is known about




the contribution of  certain  environmental noise source exposures  and
                                 7-3

-------
    patterns  of exposure  on the population's hearing sensitivity.  These




    lower  level nonoccupational noise exposures must be considered when




    investigating  the  effect of occupational noise.




                Although significant efforts are being made to improve our




    understanding  of the  relationship between noise  exposure and hearing




    loss in  industry,  little is known about the effects of varying degrees




    of  hearing  impairment on the social and economic functioning of the




    affected  individuals.  Criteria for hearing handicap have been developed




    indirectly  from speech discrimination tests which do not simulate life-




    like conditions.   The relationship between hearing sensitivity and




    social functioning must be more adequately researched.  Likewise, very




    little is known about the secondary auditory effects of NIHL such as




    tinnitus  (ringing  in  the ear),  changes  in loudness, and discomfort,  which




    are highly  annoying to hearing  impaired persons  and seem to accompany




    most hearing losses due to noise.




                Susceptibility to  noise-induced hearing loss varies considerably




    among  individuals.  Little is known about the causative factors underlying




    these  differences  in  susceptibility.  Little is  known about the suscepti-




    bility of children to NIHL.   Furthermore,  current monitoring methods do




    not allow for  the  identification of persons susceptible to NIHL.  It




    is  often  assumed  that Temporary Threshold Shift  (TTS) is correlated with




    susceptibility to  NIHL,  yet this has  not been proven in humans.



I               Properly planned studies are needed to address the inter-




    actions of  noise with other stressors.   There is little information




\   describing  whether poor health  status,  specific  disease states, ototoxic





                                       7-4

-------
drugs, or  chemical  agents  increase  predisposition to or enhance noise

induced hearing  loss.  Further,  if  a  high level noise exposure is

voluntary  and  less  aversive  to  the  individual,  there is little infor-

mation on  whether  the  net  effect  on hearing sensitivity is different.



7.1.3        EPA Priorities

             In  the EPA  document  published in 1977,  "Towards a

National Noise Strategy,"  EPA identified the important goal of^ajcing
                                      IjrC  ^eCL^fji. T£yft^^M&Wjip C
all practical  steps necessary to ^eliminate/hearing  loss as a consequence

of exposure  in the  workplace  and  the  general environment.   This program

goal will  require more detailed information on  hearing loss caused by

nonoccupational  noise.   Thus, the following EPA priorities have been

established.

             EPA will  focus on environmental exposures causing temporary

and permanent  defects  in the  auditory acuity of adults and children.

Research is  needed  to  assess  the  consequences of high level non-

occupational noise  source  exposures on the public and to determine the

contribution of  specific exposures  to the public's hearing status.

             Major emphasis will be placed on investigating the auditory

effects of noise on children.  Hearing is  considered by many to be the

most critical sense in childhood  because of language development and

its implications for overall  cognitive development and learning.

             EPA will also place high priority  on studying the interrela-

tionships between NIHL and other general  health conditions of the public.

Certain health conditions may interact with  noise to produce reduced

hearing sensitivity.

                                   7-5

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7.1.4        Current Research Activities

             The current and planned  research  activities  of  other  Federal

agencies have influenced the EPA decision  for  a  limited but  very focused

role in the category of NIHL research.  Over the  past  few years, other

Federal agencies have spent over $3 million per  year in related  research

under this category.  These agencies  have  indicated their intent to

continue at least the present level of effort  in  the future.   In the

areas of impulse noise, intermittent  noise, the  social impact  of hearing

loss and individual susceptibility research, funding levels  are expected

to rise.

             In order to better understand the responsibilities and

particular interests of other agencies in  researching  the category of

NIHL, a brief overview of the Research Initiatives anticipated to  be

undertaken by other agencies is as follows:

             Underlying Physiologic Mechanisms of NIHL

             Physiologic and biomedical research  will  continue to  be

principally supported by the National Institute  of Health (NIH) at

funding levels of approximately $1 million per year.   Other  agencies

such as the Department of Defense (DOD) will conduct research  at a

much lower funding level.

             Refinement of Criteria for Intermittent Noise and Impulse
             Noise

             The National Institute for Occupational Safety  and Health

(NIOSH) and the U.S. Army have assumed lead responsibilities in filling
                                  7-6

-------
the research gaps related to non-steady state noise and developing revised




criteria for impulse and intermittent noise.   Both animal and field re-




search will be sponsored.




             Establishment of Parameters of Individual Susceptibility




             NIOSH research plans specify the study of the interactive




effects of noise with lead and other potentially ototoxic agents.




             NIH and the U.S. Navy are planning to undertake research to




enable the identification of individuals susceptible to NIHL and to




determine causative factors underlying this enhanced susceptibility.




             Determination of Social and Economic Impact of NIHL




             The Department of Labor is presently studying the technical




appropriateness of different hearing impairment criteria used in workers'




compensation laws for NIHL.




             A related EPA research project in Fiscal Year 1980 will




attempt to develop a methodological research design for quantifying




the social and economic consequences of hearing loss with the aim of




eventually developing a more accurate index of hearing handicaps.








7.1.5        Position in the Research Continuum




             As depicted in Table 7-1, NIHL research is relatively well




advanced compared to some of the other health effects of noise.  From




years of research,  a systematic relationship has been developed between




steady-state noise exposure levels, the duration of exposure, and the




resulting hearing loss.  The statistical predictiveness of this relationship




provides a good basis for Federal occupational noise legislation.   However,





                                7-7

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                               TABLE 7-1

               POSITION ON THE RESEARCH CONTINUUM - NIHL
      Research Continuum



1.  Demonstrate existence of an
    association

2.  Demonstrate basic cause-effect
    relationship

    A.  Animals

    B.  Humans

3.  Investigate physiologic mechanisms

4.  Investigate intervening factors.
    Improve cause-effect relationship

    A.  Acoustic

    B.  Nonacoustic

5.  Quantify dose-response relationship

6.  Refinement and special populations
  Current State of Knowledge

Adequate  Marginal  Inadequate
   x

   x
                                 7-8

-------
research has not yet accounted for wide individual variations  in  suscep-

tibility to NIHL, the effect of noise with varying temporal  patterns,

nonacoustLc intervening factors, and the  severity of  NIHL.



7.1.6        List of Planned EPA Research Initiatives  for  the  Five-Year
             Plan Period

             After reviewing the status of NIHL  research,  EPA  program

needs and priorities, and the planned research activities  of other

Federal agencies, the following Research  Initiatives  for EPA funding

have been selected for the next five years.  They are  not  listed  in

order of priority.

             I.  Determine the incidence  of NIHL in the United States
                 and contribution of socLOCUS is  (nonoccupational  NIHL)
                 presbycusis (aging), and occupational hearing loss.

            II.  Establish parameters of  individual sensitivity to NIHL.

           III.  Refine criteria for low-level noise  exposure.

             These EPA Research Initiatives are  chosen based on the

following assumptions:

             1.  That other Federal agencies will continue to  play the

                 most active role in NIHL research.  Although  EPA will

                 have only limited influence on  the direction  of  this

                 research, it is anticipated that many of  the  findings

                 will be useful to EPA.

             2.  The planned research studies of other agencies will

                 be conducted with adequate funding levels until

                 completion.


                                7-9

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7.2          Detailed Descriptions of the Research Initiatives

             I.  Determine the incidence of NIHL in  the United States
                 and contribution of sociocusis (environmental exposure),
                 presbycusis (aging), and occupational exposures.

             Description and Basic Considerations.—The objective of this

Research Initiative is to isolate NIHL from other hearing loss etiologies

and estimate the magnitude of the problem caused by  different noise

source environments.  In the past it has been difficult to separate  the

hearing loss caused by age, societal factors and industry, and to predict

the hazards of noise in different environments.  This research will  assist

in describing the extent and severity of hearing loss due to different

patterns of noise source exposures.

             The principal data for this initiative  will be provided

by the National Center for Health Statistics (NCHS)  of the Public Health

Service in their periodic health surveys.  Specifically, EPA will use

the results from past, current and planned National  Health and Nutrition

Examination Surveys (HANES) in the areas of hearing-related problems,

demographic information, and indices related to noise exposure.  The

HANES survey is periodically conducted to obtain national estimates  of

the health status of the population.

             EPA will incur only data analysis costs.  Funding of $50K

per year between Fiscal Years 1981 and 1985 will be  necessary.   Cardio-

vascular and other health status information will be included in the

analysis supportive of data requirements in other research categories.

Some co-support funding is anticipated from the National Institute of

Neurological and Communicative Disorders and Stroke  (NINCDS).

                                  7-10

-------
             Expected Results.—The  resulting  analyses  will  attempt to

(1) describe hearing-related problems  caused by  recreational,  transporta-

tion and residential noise; (2) determine  the  incidence of NIHL  in the

United States; and (3) develop separate  sets of  curves  for presbycusis,

sociocusis and NIHL.  The  results of this  analysis  will then be  available

for use in source specific assessment  programs planned  for Fiscal  Years

1982, 1983 and 1984.

             All of the resulting information  will  be useful to  Federal

agencies and State and local governments in support of  regulatory,

labeling, and consumer information programs.

             II.  Establish Parameters of  Individual Sensitivity to NIHL.

             II-A.  Relationship between physiologic disease and hearing
                    loss.

             This research will attempt  to isolate  relevant  biologic

variables and physiologic  problems which are correlated with auditory

difficulties.  Certain health conditions will  be analyzed  to determine

whether they predispose an individual  to NIHL.   At  the  present  time, the

HANES survey results will  provide the  focus for  this investigation.  More

in-depth research plans are contingent upon the  results of  the HANES data

analysis and the results of research planned by  NIH and the  U.S.  Navy.  No

additional funding is being planned  above  what is  required  for Research

Initiative I.

             Expected Results.—Descriptive analyses will be provided

which show whether there are any associations  between certain health

conditions, diseases and hearing loss.


                                  7-11

-------
             II-B.  Susceptibility of special populations — children.

             While environmental noise may adversely affect people

of all ages, children may require special consideration and safeguards.

Research with animal models indicates that younger organisms are more

susceptible to NIHL than are adults.  Children may also be exposed to

different sources of noise not currently recognized as affecting hearing.

             For the past four years, EPA in cooperation with the Air

Force has funded a longitudinal study at Fels Research Institute of

the Wright State Medical school to analyze age-related changes in the

auditory thresholds of children, and to relate changes in auditory

sensitivity to environmental noise exposures and developmental and

physiologic variables.  This information is essential in order to

determine whether additional controls are necessary to reduce the

noise exposure of children.

             This research study will continue to be funded by EPA at

a level of approximately $50K per year over the next five years.   A

comparable level of co-support will be added by NINCDS to expand the

subject population to include a large sample of urban and minority

children.

             Expected Results.—Periodic results are awaited describing:

             1.  changes in the hearing sensitivity of both children
                 and teenagers related to specific environmental factors;

             2.  the consequences of a hearing loss in-childhood with
                 respect to communicative and educational problems;

             3.  whether auditory patterns and noise exposures during
                 childhood may be correlated with hearing acuity later
                 in life.

                                7-12

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             II-C.  Determine source exposures  causing  TTS  and  assess
                    debilitating consequences.

             There are many hazardous noise  environments  outside  of

the workplace which can cause temporary  reductions  in auditory  sensitivity,

commonly called ITS (Temporary Threshold Shifts).   The  results  of TTS

experiments have been used in the past to  predict permanent reductions

in hearing for persons with long-term occupational  noise  exposure.

However, TTS itself may warrant special  consideration where the reduction

in sensitivity interferes with ongoing activities.  Specifically,  the

activities of children will be investigated  where the repeated  occurrence

of TTS may have deleterious effects on education, communication and

performance.  Field and laboratory TTS studies  with children  will  be

conducted.  The Research Initiative will assess whether there is  a need

to control source exposures on the basis of  TTS.  The planned Research

Initiative will be a continuation of research started in  Fiscal Year

1980.   The funding level will be approximately  $50K.

             Expected Results.—The results  will be incorporated  into

the EPA regulatory program, State and local  noise control programs, and

public information materials for parents,  the PTA and other organizations.

Results include:

             1.   the identification of hazardous noise  conditions  par-
                 ticular to the activities of children  (e.g.  riding
                 school buses, listening to  music on stereo headsets);

             2.   determination of the amount of TTS caused  by these
                 common activities of children;

             3.   assessment of the related consequences on  education,
                 communication,  and performance.

                                  7-13

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             III.  Refine Criteria  for Low-Level  Noise  Exposures.




             Existing criteria are  extrapolated downward  from the  higher




level noise exposures in industry to  determine  the  related  auditory




risk at lower level noise exposures.  Recent  studies  have  revealed that




children, homemakers and many segments of  the public  are  exposed to




noise levels in environmental settings capable of causing  permanent




reductions in auditory sensitivity.   There  is an  urgent need  to  more




accurately estimate the lower limit of steady state and fluctuating




noise levels capable of causing permanent hearing loss  and  incorporate




these into comprehensive damage risk  criteria.




             The HANES data analyses  will determine specific  environ-




mental noise source exposure patterns associated  with reduced hearing




sensitivity.  The research effort planned under this  Initiative  will




isolate and quantify these specific source  exposures  in a  selected




population and determine the contribution of  these  source  exposure




patterns on an individual's hearing sensitivity.  Hearing  tests  will




be conducted in conjunction with dosimetry  measurements and a




questionnaire program.  Research is to start  in Fiscal  Year 1982 and




continue through Fiscal Year 1984 at  $50K/year.




             Expected Results.—The magnitude of  the  auditory problems




associated with specific environmental source exposures will  be  determined.




This information will assist in the development of  refined hearing loss



criteria.
                                  7-14

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7.3          Timing and Funding  of  the Research  Initiatives.




             See Figure 7-1.








7.4          Monitoring and Coordination




             Performance of these Initiatives  will  be coordinated with




the Interagency Regulatory Liaison  Group  (IRLG).  The IRLG has  established




a subgroup on noise, which among other things  is  concerned with the total




body burden of noise and the interaction  of  workplace noise with off-the-




job noise exposures.




             Liaison will also be maintained with the other Federal



agencies sponsoring NIHL research through  the  Federal Interagency




Noise Effects Research Panel as  well as the  ANSI  committees on  hearing




conservation criteria and impulse noise.








7.5          Research Initiatives That Will  Not Be  Undertaken by EPA




             The following research initiatives are expected  to be




undertaken by other agencies, and are therefore not considered  for the




EPA Plan:




             o  Underlying physiologic mechanisms of  NIHL




             o  Refinement of criteria for intermittent  noise and



                impulse noise




             o  Determination of social, economic,  and other  impacts



                of NIHL.




                Substantial increases in  funding  will be needed under




this (last) Initiative by other agencies.  Research initiated by EPA





                                  7-15

-------
RESEARCH INITIATIVES
I. Determine the incidence of NIHL in the U.S., and contribution
of sociocusis, presbycusis, and occupational exposures.
II. Establish parameters of individual sensitivity to NIHL.
o Relationship between physiologic disease and hearing
loss. (included in I)
o Susceptibility of special populations - children (Fels -
Continuation from 1976). *
o Determine source exposures causing TTS and asses
debilitating consequences. (Begun in FY 80.) *•
III. Refine criteria for low-level noise exposures,
TOTALS
Fiscal yc
1981
$50K
$50K
$50K

$150K

1981
»ar fund in
1982
$50K
$50K
$50K
$150K

1982
g
1983
$50K
»
$50K
$50K
$150K

1983
1984
§50K
S50K
$50K
$150K

1984
1985
$50K
$50K
$100K

1985
FIGURE 7-1.   TIMING AND EPA FUNDING FOR NOISE-INDUCED HEARING LOSS (NIHL)

-------
and Che Department of Labor  in Fiscal  Years  1979  and 1980 should provide




focus as to what is needed and the  ramifications  of the work.   Workers




compensation costs for NIHL  are  predicted  to  increase to approximately $1




billion over the next 10 years,  yet  little is  still known about the




adequacy of current criteria in  terms  of  the  real social and economic




impacts.  Increased research above  what is  presently being planned is




mandatory.  The real cost  to the nation of NIHL  remains unknown.








             o  Establishment of Parameters  of Individual Susceptibility




             This Research Initiative  will  be  partially undertaken by



EPA.  It is listed both in the EPA  Plan as  Initiative II and in Che list




of Initiatives being undertaken  by  NIH and  the Navy (in Section 7.1.4).
                                  7-17

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8.  RESEARCH PLAN FOR




        BEHAVIORAL, SOCIAL AND




        PERFORMANCE EFFECTS

-------
                       TABLE OF CONTENTS
Concents
8.1   Rationale for Selecting Specific Research
      Initiatives

      8.1.1     What is Known                                      8-1

      8.1.2     What is Not Known                                  8-3

      8.1.3     EPA Priorities                                     8-4

      8.1.4     Ciirrent Research Activities                        8-5

      8.1.5     Position on the Research Continuum                 3-7

      8.1.6     List of Planned EPA Research Initiatives           3-7
                for the Five-Year Period

8.2   Detailed Descriptions of the Research Initiatives

       I.       Effects of Noise on Cognitive and                  o-j
                Behavioral Development

      II.       Behavioral and Social Adjustment of Noise          3-10

8.3   Timing and Funding of the Research Initiatives               8-11

8.4   Monitoring and Coordination                                  3-11

8.5   Research Initiatives That Will Not 3e Undertaken bv EPA      8-11
                             S-ii

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    8.  RESEARCH PLAN FOR BEHAVIORAL, SOCIAL AND PERFORMANCE EFFECTS









            The long-term objective of research under this category is




to determine the effects of noise on social behavior, mental health and




human performance.








8.1         Rationale For Selecting Specific Research Initiatives








8.1.1       What is Known








            The behavioral, social and performance effects category is a




very broad category encompassing most aspects of personal and social




adjustment and performance.  These effects are often complex, subtle and




indirect, and the result of complex interactions with nonacoustic variables.




            By a wide margin, the greatest amount of scientific attention




has been devoted to relatively short-term laboratory investigations




(typically exposures of one hour or less) of the performance of mental




and motor tasks under noise.  Unfortunately, findings to date have been




quite ambiguous and controversial.  Although no direct, simple statements




are possible, some rather general conclusions can be drawn.




            It is probably safe to conclude that few performance decre-




ments occur under steady state noise when the level is below 80 to 90




dB.  A number of studies have shown that exposure to unpredictable or




aperiodic intermittent noise may result in more pronounced performance




effects, even at levels considerably below 80 to 90 dB.  Changes in the




prevailing noise level may also have an adverse effect on performance.
                                   8-1

-------
            Tasks Chat require simple, repetitive operations are usually




unaffected and sometimes even improved by the presence of noise.  On the




other hand, most performance decrements have been found on complex tasks




that require continuous activity, prolonged attention, or the accomplish-



ment of two or more simultaneous tasks.  Noise has often been found to




reduce the accuracy rather than the overall rate of performance.




            Research has shown that motivational and personality variables




can influence the effects that noise will have on performance.  A fairly




recent series of studies demonstrated that although performance may be




unaffected during noise exposure, impairments may occur after the noise




stops.  It has also been demonstrated that providing the individual with




the perception of control over the noise resulted in the elimination of



these effects.  These findings suggest the importance of contextual and




other nonacoustic variables in influencing performance under noise.



            A small amount of laboratory research suggests that noise



may have an adverse effect on certain aspects of social behavior.  There



has been work on the relationship between noise and social conformity,



aggression, verbal disinhibition, and altruistic (helping) behavior.



            There is a growing body of evidence which shows that noise



adversely affects the learning and cognitive development of children.



Studies have shown that auditory discrimination and reading achievement



are adversely affected in children attending school or residing in high




noise environments.   These studies represent some of the few attempts to



assess long-term performance effects.
                                   8-2

-------
            There have been a few other scattered attempts to assess the



long-term effects of noise in field settings.  There is some evidence of




decreased productivity and increased absenteeism and accidents among




workers exposed to high noise levels on the job.  Some correlational



research has also been performed on the relationship between noise



exposure and mental hospital admissions, showing increased admission




rates in high noise environments.  Social survey work has revealed



positive associations between the noise levels and various symptoms of



psychological stress and negative affective states.








8.1.2       What Is Not Known








            Thus far, no direct cause-effect relationships have been



derived that quantitatively express the effects of noise on performance



or other kinds of behavior.



            A major stumbling block to progress is that there are few,



if any, direct effects of noise on performance.  Under most circumstances,



it is not practicable to predict effects by relying only on information



concerning the physical parameters of the noise.  Although we have



acquired some knowledge of the connection between noise and performance,



the exact relationship is quite complex and often dependent upon many



elusive nonacoustical parameters such as the demands of the task, inter-




vening factors of the performance situation, and the presence of intrinsic



personality variables.  Identification,  description and quantification



of the many non-physical parameters is clearly required before a concern
                                   8-3

-------
with performance as disrupted by noise will become a critical factor in




influencing the nature, direction and stringency of noise control programs.




            Precise data are needed on the effects of noise on the




cognitive and social development of children.  Noise does appear to




interfere with the acquisition of important language and reading skills.




            It is not known with any certainty, the extent to which




noise may adversely affect work performance and social behavior in real




world situations.  If people are forced to cope with noise, the question



is what, if any, are the costs incurred as a result of the extra effort




required to cope with noise?  Are there affects which occur after the




noise is no longer present?  Research is needed to determine whether




existing laboratory findings are generalizable to natural settings.



            Information is lacking on the relationship between noise and



social and mental pathology.  Methodologically sound studies in this



area are needed.  Very little is known about individual differences in



sensitivity to noise.  Research is needed to help explain the observed




large variability in individual sensitivity to noise.








8.1.3       EPA Priorities



            As pointed out previously, there is ample support for the



contention that behavioral effects of noise are of direct concern to



EPA, in view of EPA's responsibility of guarding public health and



welfare.  The potential adverse behavioral effects of noise are great



and include not only unnecessary disruption of productivity but also



accidents on the job, absenteeism,  effects on learning, social behavior,
                                   8-4

-------
and increased social problems like crime.  Quantified dose-response




relationships between noise and adverse behavioral, social and performance




effects are now completely lacking.  However, there are promising avenues




along which future research should be directed in support of EPA's




requirements.




            Taking into consideration current funding estimates, rela-




tively little research can be adequately carried out in this health



effects category over the five-year period.  Based on programmatic needs



and other factors, emphasis will be placed on investigating the effects



of noise on children and studies of behavioral and social adjustment to




long-term noise exposure.








8.1.4       Current Research Activities








            At the present time, EPA is not sponsoring any research in



the behavioral category.  The amount of related activity by other Federal



agencies has also been less than adequate.  Only seven studies have been




undertaken by other agencies in the last few years, at a cost of approxi-




mately $500K.  According to the information gathered to date in the



update of the Panel Report, overall funding levels may have declined in




this category of research.  Moreover, with few exceptions, much of the



ongoing research does not seem to be directly applicable to everyday



environmental noise problems.



            Some of the specific research activities include the following:
                                   8-5

-------
Studies by Che Department of Defense (DOD) assessing




the performance effects of noise (and other environ-




mental stressors) in military situations.  Some of the




findings of these studies may be applicable to EPA




questions concerning the interaction of noise and




other stressors in affecting performance.








A small study by the National Institute of Mental



Health (NIMH) investigating personal adjustment to




urban noise.








Performance effects research by the National Science




Foundation (NSF) investigating the relationship between




noise control in the workplace and productivity.








Research by the National Science Foundation (NSF) on



the effects of environmental noise on children's



attentional strategies and generalized expectations




concerning controls.








A study sponsored by the State of California on



achievement test scores of elementary school children



in schools near freeways.
                 8-6

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8.1.5       Position on the Research Continuum

            From Table 8-1, it is clear that compared to some of the

other health effects research categories, research in many facets of the

behavioral category is still in the exploratory phase.  With the exception

of laboratory studies of task performance, suspected effects have been

identified, but not sufficiently investigated.



8.1.6       List of Planned EPA Research Initiatives for the Five-Year
            Period

             I.  Effects of Noise on Cognitive and Social Development

            II.  Behavioral and Social Adjustment to Noise



            These initiatives, together with their proposed funding

levels, have been chosen based on the following assumptions:

            1.  Due to the relatively low level of emphasis placed on

this category, only limited funding will be available during the five-

year Plan period.

            2.  Because Research Initiatives in higher priority categories

must be started as soon as possible, limited EPA resources make it

necessary to defer research startups in this category until Fiscal Year 1983.



8.2         Detailed Descriptions of the Research Initiatives

             I.  Effects of Noise on Cognitive and Social Development

            Description and Basic Considerations.—A relatively small

but growing literature exists showing that environmental noise is
                                   8-7

-------
                                      TABLE 8-1



   POSITION ON THE RESEARCH CONTINUUM - BEHAVIORAL. SOCIAL, AND PERFORMANCE EFFECTS



    Research Continuum                                Current State of Knowledge

                                                    Adequate   Marginal  Inadequate

1.  Demonstrate existence of an association                        X*

2.  Demonstrate basic cause-effect relationship

3.  Investigate physiologic mechanisms                                        X

4.  Investigate intervening factors.  Improve
      cause-effect relationship

        A.  Acoustic                                                          X

        B.  Nonacoustic                                                       X**

5.  Quantify dose-response relationship                                       X

6.  Refinement and special populations                                        X***
  *     Task performance studies only

 **     Much research in this area has established that nonacoustic factors
        have a strong influence in most aspects of this category.

***     Generally inadequate, but research indicates that noise does
        interfere with the acquisition of important language and reading
        skills in children.
                                         8-8

-------
associated with impaired speech discrimination or understanding, reading

achievement, problem solving, and task performance in children.  This

research has involved infants through young adolescents, and has dealt

with noise in both home and school environments.  Other research exists

which indicates that certain groups of special children may be even more

sensitive to noise than normal children.

            The aim of this Initiative is to determine the extent to

which living or attending school in high noise areas has adverse effects

on cognitive and social development.

            A.    In the first phase, an appraisal of the existing data

will be carried out, using not only noise studies per se. but other

relevant studies as well.  A fairly extensive literature base reveals

the importance of early environmental stimulation on the development of

both animals and humans.  Other research has dealt with the concepts of

selective attention and distraction in children, particularly with

respect to learning and performance in educational settings.

            The first phase will be undertaken in Fiscal Year 1983 at a

cost of $60K.

            B.    In the second phase, a lab and/or field study will be

conducted, incorporating the following factors in its design.

            o     Socioeconomic characteristics (age, race, sex)

            o     School performance (in-class performance, homework
                  performance, standardized tests.)

            o     Social behavior (in home; at school)

            o     Acquisition of speech and language

            o     Performance of selected tasks (psychomotor, cognitive).
                                   8-9

-------
            The second phase will be funded at a level of $150K in



Fiscal Year 1984 and $100K in Fiscal Year 1985.




            Expected Results.—The results of the first-year appraisal




will be used to develop the protocol of the study.  The study will yield




some of the information necessary for deriving quantitative dose-response




criteria including speech communication criteria for children.








            II.   Behavioral and Social Adjustment to Noise



            Description and Basic Considerations.—Many of the behavioral




effects of noise are complex, subtle and indirect.  Although it is




widely accepted that noise has disruptive effects, little is known about



how people adapt to and cope with noise in their environment.  Research




under this Initiative will try to assess and quantify some of the major




adverse effects of noise on social and personal adjustment.



            The emphasis will be on methodologically sound studies of



long-term adaptation to noise.  Attempts will be made to assess the



social and behavioral costs of adaptation and, where warranted, to



assess the generalizability of laboratory findings to naturally occurring



situations.



            In the first phase, the literature will be reviewed and



evaluated to 1) determine which areas of behavioral and social adjustment



offer the most promise in providing criteria and 2) the specific research



questions that need to be addressed.  Research studies will then be



designed and implemented under the second phase of this Initiative.
                                   8-10

-------
            The appraisal of literature will be conducted in 1983 at a




level of funding of $55K.  Research studies will be conducted in Fiscal




Years 1984 and 1985 at funding levels of $110K and $250K, respectively.




            Expected Results.—Results of the literature appraisal will




be used to decide which topics should be selected, and in designing the




specifics of the research studies planned for the following years (Fiscal




Years 1984-6).  Only preliminary results may be expected from the research



before Fiscal Year 1986.








8.3         Timing and Funding of Research Initiatives



            See Figure 8-1.








8.4         Monitoring and Coordination








            During the appraisal work, liaison will be maintained with



scientific groups to provide important inputs for the research design of



the planned studies.  Workshops for this purpose are also being considered.



            Coordination will be maintained with such agencies as DOD,



NSF and NIMH and through the Noise Effects Advisory Group.








8.5         Research Initiatives That Will Not Be Undertaken by EPA








            The scientific appraisals currently planned will place EPA



in a position to move into studying two major topics under  these two



Initiatives.  Other topics will be identified, but due to limited



resources will not be started.   It is too early to list these topics.
                                   8-11

-------
       RESEARCH INITIATIVES
                                                                            Fiscal year funding
                                                                             1981
1982
1983
1984
1985
       T.  Effects of noise on cognitive and  social development.
      II.  Behavioral and social adjustment  to  noise.
                                                               TOTALS
oo
i
         $60K
         $150K
         $55K
         $115K
         $260K
                                                                               1981      1982     1983
                    1984
         $100K
         $110K  I  $250K
         $350K
                    1985   j
                        FCGURE 8-1.  TIMING AND EPA FUNDING FOR BEHAVIORAL, SOCIAL-AND PERFORMANCE RESEARCH

-------
            Other major Initiatives will not be addressed at all.  These

include:

            o     The relationship of noise to mental pathology
                  (virtually no attention under this Plan)

            o     The role of acoustic and nonacoustic factors on task
                  performance

            o     Individual differences in sensitivity to noise

            o     Interaction of noise with other stressors in the
                  performance situation
                                   8-13

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9.   RESEARCH PLAN FOR




        COMMUNICATION INTERFERENCE

-------
                  TABLE OF CONTENTS



Contents                                                          Page


9.1   Rationale for Selecting Specific Research
      Initiatives


      9.1.1     What is Known                                     9-1

      9.1.2     What is Not Known                                 9-2

      9.1.3     EPA Priorities                                    9-3

      9.1.4     Current Research Activities                       9-4

      9.1.5     Position on the Research Continuum                9-6

      9.1.6     List of Selected EPA Research Initiatives         9-6


9.2   Detailed Descriptions of the Research Initiatives           9-6


9.3   Timing and Funding of the Research Initiatives              9-6


9.4   Monitoring and Coordination                                 9-6


9.5   Research Initiatives That Will Not 3e Undertaken            9-8
      bv EPA

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            9.  RESEARCH PLAN FOR COMMUNICATION INTERFERENCE








            The long-term EPA objective for research on Communication




Interference is to determine and quantify the effects of noise on communi-




cation and its developmental, social and other implications.




            The reader should note that the contents of this chapter and




the following chapters differ from the others thus far, in that Research




Initiatives are proposed but none are expected to be funded by EPA due




to higher priorities and resource constraints.








9.1         Rationale for Selecting Specific Research Initiatives








9.1.1       What is Known




            The ease with which normal-hearing adults can communicate




with each other face-to-face, or understand speech over communication




systems such as telephones, intercoms, radios, and the like, is governed




primarily by the amount of background noise present in the environment.




Although individuals can compensate to some degree for the interference




created by masking noise by raising their voices,  or by listening more




carefully, such compensation is often tiring and unpleasant, and in




extreme background noise conditions,  ineffective.




            Most research on the adequacy of speech communication was




initially conducted in the context of evaluation of military communica-




tion systems.  More recently, this body of knowledge has been applied to
                                   9-1

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the slightly different problem of determining the effects of environmental

noise on face-to-face communication.  The fundamental tools used for

assessing the acceptability of speech communication are procedures for

estimating speech intelligibility on the basis of assumed background

noise spectra and speech levels.  A number of efforts have been made to

equate percentages of words and sentences correctly understood within

fixed contexts to typical speech and noise characteristics.  Thus, EPA

has developed and published in the "Levels Document"* general purpose

criteria relating levels of continuous noise to percentage of sentence

intelligibility at specific distances under normal, face-to-face speaking

conditions.  One set of criteria exists for indoor speech interference

and one for outdoor speech interference.  These criteria are judged to

be adequate for most Federal regulatory purposes.  In addition, criteria

exist for intelligibility where the speaker has exerted greater vocal

effort to overcome perceived background noise, for cases where the

communications are perceived by the speaker as "vital" or "not vital."



9.1.2        What is Not Known

             Although the major acoustic determinants of speech inter-

ference are well known, the assessment of the quality of face-to-face

verbal communication is not yet a routine matter.  This is so because

nonacoustic circumstances of the communication situation have not yet

been reduced to a manageable set of standard conditions.  For example,
* Information on Levels of Environmental Noise Requisite to Protect
  Public Health and Welfare with an Adequate Margin of Safety, U.S. EPA
  550/9-74-004, March 1974.
                                 9-2

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it is not yet known at what distances people actually choose or attempt




to communicate indoors, outdoors, and in other special environments




(schools, transportation vehicles, public meeting places, group gatherings,




etc.).




             Similarly, the degree to which other non-standard conditions




affect speech intelligibility (such as non-native or inexperienced, or




very young, old, or hearing-impaired speakers or listeners) are not yet




usefully quantified.  By the same token, it is not yet known how unusual




background noise conditions (such as intermittent high level or time




varying noise) affect satisfaction with speech communication.




             Additional gaps exist in our knowledge of the indirect




effects of communications interference.  These include:  effects on



education, safety and the quality of everyday social interactions.




There are numerous anecdotal reports of noise interference in the




classroom.  Likewise, there are reports of safety hazards in a number of




different traffic and industrial situations due to the masking of emer-




gency signals.  None of these more indirect effects of communications




interference by noise has been quantified.








9.1.3        EPA Priorities




             To continue to support the EPA mission of protecting the




public health and welfare from the adverse effects of environmental




noise, research must now focus on refined criteria which will be helpful




in assessing the effects of noise on special subpopulations, the effects




of special noise patterns on the population, and the indirect effects of




noise on safety, productivity and performance.
                                  9-3

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            From EPA's point of view, therefore, the most useful specific

directions for work refining criteria are to:

            o     Establish criteria for special groups (elderly,
                  children, hearing-impaired, people with English as a
                  second language)

            o     Establish criteria (families of dose-response curves)
                  for:

                     -  relaxed vocal effort indoors
                     -  relaxed vocal effort outdoors
                     -  relaxed vocal effort inside transportation
                        vehicles

            o     Establish better criteria for time-varying noise.

In addition, EPA needs to understand better the indirect adverse effects

of disruption of speech by noise.  These include the question of safety,

extreme annoyance, disturbance of normal activities such as domestic

life or learning, and effects on social interaction.  Of particular.

interest, and already addressed by a Research Initiative in the behavioral,

social and performance effects Plan, is the determination of the effects

of noise on teaching and learning activities.  Thus it can be seen that

understanding of communication interference is a necessary aspect of

work in some of the other research categories.



9.1.4       Current Research Activities

            EPA is presently providing indirect support in this area

through the Pels longitudinal study.  The speech discrimination abili-

ties of children are being investigated under different noise conditions.

Other Federal agencies are much more directly active in this category.

According to the information gathered to date in the update of the Panel
                                   9-4

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Report, over $1 million has been spent by other agencies on at least




nine projects over the last few years.  Three agencies are significantly




involved in investigating the effects of noise on the speech perception




of special groups of people.  Their specific research activities include




the following:




             o     The National Institute of Neurological and Communicative




                   Disorders and Stroke (NINCDS) has sponsored the bulk




                   of the research.  Their research includes studies of




                   speech perception problems of children and the hearing-




                   impaired.








             o     The Veterans Administration is investigating the




                   acoustic needs of aphasics (persons with neurologically




                   damaged language functions).








             o     The National Institute of Environmental Health Sciences




                   (NIEHS) has sponsored studies of the effects of time-




                   varying noise on communication interference of people




                   with special hearing problems.








             o     In addition, branches of the Department of Defense are




                   continually undertaking research studies in assessing




                   and redesigning speech communication systems for




                   maximum communication effectiveness and the least




                   interference by noise.
                                     9-5

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9.1.5        Position on the Research Continuum




             General criteria have been achieved, and work is now pro-




ceeding on refined criteria and factors related to special populations




(See Table 9-1).








9.1.6        List of Selected EPA Research Initiatives




             There are no EPA Research Initiatives slated for funding in




this five-year Plan period.  However, EPA has developed a set of Research




Initiatives which are important from the EPA standpoint.  Those are




described in Section 9.5 of this Plan.




             Moreover, part of a needed Initiative will be carried out




under the Plan for behavioral, social and performance effects.  Under




Initiative I, as part of the study of effects of noise on learning,




preliminary work on developing speech criteria for children will be




conducted.








9.2          Detailed Descriptions of the Research Initiatives




             (Not applicable, See Section 9.5).








9.3          Timing and Funding of the Research Initiatives



             (Not applicable).








9.4          Monitoring and Coordination




             Although EPA will not need to coordinate with outside




groups with respect to EPA projects, it will be necessary to stay abreast
                                   9-6

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                                  TABLE 9-1
       POSITION ON THE RESEARCH CONTINUUM - COMMUNICATION INTERFERENCE
    Research Continuum



1.  Demonstrate existence of an association

2.  Demonstrate basic cause-effect relationship

3.  Investigate physiologic mechanisms

4.  Investigate intervening factors.  Improve
      cause-effect relationship

         A.  Acoustic (impulse, intermittent)

         B.  Nonacoustic (situational factors),

5.  Quantify dose response relationship

5.  Refinement and special populations
  Current State of Knowledge

Adequate   Marginal  Inadequate

    X

    X

              NA
               X
    X*
                         X
*   Adequate for normal-hearing adults only under ideal listening contexts.
                                     9-7

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     of progress made by other research agencies so that work useful to the




EPA mission may be acquired in a timely fashion.  Of particular relevance




in this regard is work being conducted by NINCDS and NIEHS.  In addition




there will be continuing active participation in ANSI committees dealing




with speech intelligibility.








9.5          Research Initiatives That Will Not Be Undertaken by EPA




             The following Initiatives will not be undertaken by EPA due




to limited resources available:








             o     Relaxed Conversation in Different Environments




             Under this Initiative are included criteria for relaxed




conversation indoors, outdoors, and inside transportation sources (cars,




trains, buses, etc.).








             o     Speech Intelligibility for Special Groups




             Special dose-response criteria are needed for the elderly,




children, and the hearing-impaired (both listeners and speakers) and for




dialects and speech as spoken by non-native speakers.








             o     Effect of Time-Varying Noise on Speech Intelligibility




             The effects of time-varying noise of various types (e.g.,




passbys, overflights, periodic sources) need to be studied in laboratory




conditions to develop appropriate criteria.
                              9-8

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             o     Communications Interference Effects in High-Noise Work




                   and Traffic Environments




             The objective of this Initiative is the eventual quantifi-




cation of risk from accidents caused by failure to hear warning signals,




of loss of productivity, and decrements in performance where auditory




communication is required.  As such, the contents of this Initiative are




similar to and partly covered by the Initiatives to be pursued under the




behavioral, social, and performance effects research Plan.
                              9-9

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10.   RESEARCH PLAN FOR EFFECTS OF




           NOISE ON WILDLIFE AND OTHER ANIMALS

-------
                       TABLE OF CONTENTS



 Contents                                                          Page


 10.1  Rationale for Selecting Specific Research
       Initiatives

       10.1.1    What is Known                                     10-1

       10.1.2    What is Not Known                                 10_2

       10.1.3    EPA Priorities                                    10_3

       10.1.A    Current Research Activities                       10-4

       10.1.5    Position on the Research Continuum                10-4

       10.1.6    List of Selected EPA Research Initiatives         10-4


10.2   Detailed Descriptions of the Research Initiatives           10-4


10.3   Timing and Funding of tne Research Initiatives              10-4


10.4   Monitoring and Coordination                                 10-4
10.5   Research Initiatives That Will Not Be Undertaken            10-6
       by EPA

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  10.  RESEARCH PLAN FOR EFFECTS OF NOISE ON WILDLIFE AND OTHER ANIMALS









            The long-term EPA objective for noise effects research in




this category is to determine and quantify the effects of noise on




wildlife and domestic animals.








10.1        Rationale for Selecting Research Initiatives








10.1.1      What is Known




            Research on effects of noise on laboratory animals is fairly




plentiful.  While its purpose is usually to apply findings to human




beings, it also serves to focus attention on the range of potential




noise effects on domestic animals and wildlife.  The applicability of




the existing laboratory research is limited, however, by at least two




factors:  (1) the extreme noise levels or other unnatural exposure




characteristics presented in many of the experiments, and (2) the use of




species which, for the most part, are different from the wild animals of




interest.  Considering these limitations, laboratory research has demon-




strated the following potential effects of noise:  noise-induced hearing




loss; nonauditory physiologic effects; important behavioral changes;



masking of auditory signals.




            A number of studies have demonstrated some adverse, and a




few beneficial, noise effects in domestic animals, such as cattle,




sheep, pigs and fowl.  Largely, these studies employ experimental and




unnatural noise conditions,  rather than typical noise environments for
                                   10-1

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these animals, such as highway and aircraft noise.  Effects observed




include adverse color changes in meat, other metabolic changes in sheep




and lamb, reduced egg hatching due to decreased broodiness in hens, and



startle and alarm responses in all species studied.




            Very little is known about effects of noise on wildlife.




Only a handful of studies exist, and these are largely anecdotal or




based on captive wild animals.  Many wild animals, fish and birds are




startled by noise, but the response appears to habituate in a number of




species.  Attempts to use noise to repel species considered pests have



failed for this reason.  Where flight from noise does occur, it is




unknown whether there are any adverse consequences.  Adverse physiologic




effects either have been noted or suggested in a number of species,



including caribou and deer.  These were noted under artificial conditions,




however, and any effects in the wild are unknown.



            An area of potential concern is masking effects of noise.




Noise interferes with the hearing of desired signals for animals just as



for humans.  While this masking is known to occur, we can only suggest




possible effects on auditory behaviors such as when evading predators;



locating mates, young and prey; defining territory; and avoiding harm



from falling trees and other hazards.








10.1.2      What is Not Known




            With regard to domestic animals, existing information on



noise effects on growth, metabolism, reproductive, physiological and



behavioral activity needs to be expanded and refined.  Special emphasis
                                   10-2

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should be placed on quantifying effects in everyday noise exposure




situations for these animals.  At present, the impact of different noise




sources such as highways and airports cannot be estimated.




            Effects on physiologic functioning, hearing, communications




and behavior are all unknown, although many potential effects have been




hypothesized.  A prerequisite for much of the needed research is to




measure the hearing thresholds of the species of concern, because animals



often have auditory sensitivities greatly different from humans.




Thresholds of audibility across frequencies are known for some species,



but unknown for others.








10.1.3      EPA Priorities



            The highest EPA noise program priority in this research



category is the identification and quantification of effects of noise on



susceptible animal populations.  At this time, these are judged to be:



            o     Endangered species;




            o     Animals heavily reliant on audition for survival, for




which continuous masking noise in the habitat could have grave effects



(such as fish, marine mammals and birds);




            o     Animals which are important to humans for food, such



as livestock, fowl, fish and other marine animals.




            It is important for research to focus on effects in natural



or typical settings because confined animals will show different effects.
                                   10-3

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It is also important to study everyday noise levels due to exposures




from typical mechanical noise sources or products (as opposed to water-




falls and other natural sources).








10.1.4      Current Research Activities^




            EPA is not proposing to conduct any research activities in




this category within the five-year time frame.  It also appears that no




research is presently being sponsored by other Federal agencies such as



the Department of Agriculture and the National Park Service.
10.1.5      Position on the Research Continuum




            Overall, existing knowledge is not adequate for an appraisal




of noise effects on wildlife and other animals.  (See Table 10-1).








10.1.6      List of Selected EPA Research Initiatives



            Due to higher priorities and limitations in resources, EPA




will not be funding any Initiatives in this category within the Five-



Year Plan period.  A set of Initiatives has been developed, however, and



is listed in Section 10.5.  It is hoped that these may be pursued by



other agencies.








10.2        Detailed Descriptions of the Research Initiatives



            (Not applicable.  See Section 10.5).
                                   10-4

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                                     TABLE 10-1
               POSITION ON THE RESEARCH CONTINUUM — WILDLIFE EFFECTS
    Research Continuum
                Current State of Knowledge

              Adequate   Marginal  Inadequate
1.  Demonstrate existence of an association
                             X
2.  Demonstrate basic cause-effect
      relationship
3.  Investigate physiologic mechanisms
4.  Investigate intervening factors.
      cause-effect relationship

        A.  Acoustic

        B.  Nonacoustic
Improve
                                        X

                                        X
5.  Quantify dose-response relationship
6.  Refinement and special populations
                                         10-5

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1Q.3        Timing and Funding of the Research Initiatives




            (Not applicable.)








10.4        Monitoring and Coordination




            Although EPA has no plan to undertake research within the




next five years, it is essential to learn from ongoing studies being




conducted elsewhere.  This information is very relevant to EPA program




activities.








10.5        Research Initiatives That Will Not Be Undertaken by EPA




            These Initiatives will produce results relevant to EPA




programmatic activities.  (Note that there is considerable potential




overlap among Initiatives.)  It is hoped that some of them will be




undertaken elsewhere during the Five-Year Plan period.








            o     Noise Impact on Endangered Species



                  The objective of this Initiative is to produce criteria



where adverse effects are found to occur in threatened species.  Studies



should focus on long-term effects found in natural habitats where noise



made by humans may occur.








            o     Impact of Masking Noise on Susceptible Species



                  This Initiative comprises studies on species heavily



reliant on audition for activities such as locating offspring, mates,



prey and/or predators, defining territories, and other activities related
                                   10-6

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to survival.  These studies should focus on long-term effects in natural

habitats, using typical man-made noise sources.



            o     Impact of Noise on Species Prominent in the Production
                  of Food for Humans

                  This Initiative addresses the impact of noise exposure

on livestock, domestic fowl, fish and other marine animals.   Of particu-

lar importance are stress effects in farm animals.  Typical  noise sources

for each species should be investigated.
                                   10-7

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11.   RESEARCH PLAN FOR




          EXPOSURE CHARACTERIZATION

-------
                       TABLE OF CONTENTS
 Contents                                                         Page


11.1  Rationale for Selecting Specific Research                   11-1
      Initiatives

      11.1.1    What is Known                                     11-1

      11.1.2    What is Not Known                                 11-2

      11.1.3    EPA Priorities                                    11-3

      11.1.4    Current Research Activities                       11-4

      11.1.5    Position on the Research Continuum                11-5

      11.1.6    List of Planned EPA Research Initiatives          11-5
                for the Five-Year Period

11.2  Detailed Descriptions of the Research Initiatives           jj.g

11.3  Timing and Funding of tfie Research- Initiatives              11-6

11.4  Monitoring and Coordination                                 11-6

11.5  Research Initiatives That Will Not Be Undertaken            11-6
      by EPA

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             11.  RESEARCH PLAN FOR EXPOSURE CHARACTERIZATION








            The long-term EPA objective for research in this category is




to determine patterns of noise exposure, typical noise doses attributable




to different sources and/or environments, and health-related consequences




of these exposures.








11.1        Rationale for Selecting Specific Research Initiatives








11.1.1      What is Known




            Current knowledge of the noise exposure of the American




population is composed primarily of source and situation information.




Information about source levels is quite comprehensive.  Typical levels




produced by virtually all types of high-level noise sources and a great




many moderate- to low-level noise sources have been measured, tabulated,




analyzed, and compiled many times.  Standards for measuring many noise




sources have been proposed and/or adopted.  Some of these standard




procedures deal with technical details of physical aspects of measurement,




while others deal with means of calculating complex indices and contours




of various sorts.  Computerized models of noise levels produced by




simultaneous operation of multiple noise sources engaged in specific




activities have also been devised.  Information about noise levels




encountered in different environments, although less comprehensive than




information about sources per se, is nonetheless quite extensive.  Noise




levels of many indoor and outdoor spaces have also been repeatedly
                                   11-1

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measured.   Some  limited  studies have been undertaken  assessing exposures




of workers,  military  personnel, homemakers and children over  24-hour and




longer periods.  For  the most part, these studies have shown  rather high




individual  exposures  over  these periods.








11.1.2       What is Not  Known




             Many studies have been undertaken which have increased our




knowledge of source and  situation contributions to the undesirable




effects of  noise.  However, these studies so far have not provided us




with critically needed information concerning how people interact with




their total  noise exposure environments and the implications  of this




interaction  with respect to the health-related consequences of noise




exposure.  The emphasis  is on knowing the levels and patterns of noise




actually received by  people as they move from environment to  environment.




With this information, noise doses can be better related to health




effects, such as hearing loss that depend on a 24-hour dose and not just



on the exposure at work.




             For example,  knowledge about individual exposure  patterns is




quite fragmentary.   It is not yet known, for example,  whether groups of




people engaged in similar occupations share similar individual exposure




patterns outside of work; whether certain subgroups of the population




are more heavily exposed to noise than would be suggested by  their




occupations; whether  recreational and other forms of voluntary noise




exposure contributes substantially to the total daily noise dose;  and so




forth.   One  reason this issue is so important is that certain population
                                   11-2

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subgroups may be more susceptible to noise effects due to their total




noise dose, both inside and outside work.




            Results of a few preliminary dosimetric studies are not yet




readily interpretable, due to a number of technical problems and small




sample sizes.  A major uncertainty in exposure characterization is the




careful determination of the relationships between source and situation




oriented measures of noise levels and measures of personal exposure.




Most importantly, the critical relationships between personal noise




exposure patterns, and the incidence and magnitude of the harmful effects




of noise, have yet to be derived.








11.1.3      EPA Priorities




            There are many reasons to undertake a national program to




assess individual or personal noise exposure.  A primary need is to




obtain information which will enable EPA to determine the kind and




extent of the principal known effects of noise on health and welfare due




to all of the varying noise exposure patterns typical of different




personal lifestyles.  Such information will also aid in determining the




relative importance of typical environmental noise situations experienced




day to day.  Furthermore,  it will help to develop and validate predictive




models to assess the contribution of specific sources of situations to




the total noise problem.   Information to be obtained must include site




specific monitoring, identification of lifestyles, personal noise




monitoring and exposure time-histories,  and recognition of human response




patterns.
                                   11-3

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            To that end, EPA program priorities require that both indivi-




dual dosimetric and site specific studies be conducted to quantify the




sources and situations responsible for major contributions to total at-




ear noise exposures.  It is also recommended that such studies concern




themselves with differences in exposure patterns for different segments




of the population, and that exposure patterns in turn be associated with



patterns of activity such as sleeping.  Additional study is desirable




ultimately to associate noise effects information from all the other




research categories with patterns of personal at-ear exposures.  This




will help to establish the incidence and severity of different noise-




related effects on the U.S. population.








11.1.4      Current Research Activities



            EPA has undertaken a relatively small-scale base year effort



of site-specific community noise monitoring.  Specifically, this activity



will attempt to define national ambient noise levels over time within an



array of environments, and to identify specific noise source contribu-



tions to those noise environments.



            Additionally, EPA is completing in the base year a study of



typical daily activity patterns of the United States population, as well



as various population subgroups identified on the basis of a number of



occupational and demographic characteristics.  The objective of this



study is to relate particular lifestyles or patterns of human activity



to noise exposure and/or dosimetry information to be gathered in the




future.
                                   11-4

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            In the Fels longitudinal study being jointly sponsored by




EPA and the Air Force, measurements are being taken of the specific




noise exposures of children and the major source contributants to their




total daily noise exposures.  Individual noise exposures will be measured



in a serial manner to determine changing noise exposure patterns as a




function of age and sex.  The measured exposures will then be related to



the childrens' hearing abilities in an effort to determine the resulting



auditory effect caused by noise.




            Other Federal agencies have little additional related research




in progress or planned.  The only exception is the Air Force and Navy




who are assessing personal monitoring methods using dosimeters, and




measuring military noise exposures and exposure patterns.








11.1.5      Position on the Research Continuum



            Not directly applicable.  Only limited exposure information



has been related to the various effects of noise.








11.1.6      List of Planned EPA Research Initiatives for the 5-Year Period




            There are no direct EPA Research Initiatives slated for



funding in this five-year Plan period.  Some limited work will be in-



directly conducted by EPA under Initiative I in the NIHL Research Plan.



Data from national health surveys of the Public Health Service will be



used to relate the hearing status of the public to certain demographic




indicators and indirect indices of exposure.  However, EPA has developed




a set of Initiatives which are important.  They are described in Section



11.5 of this Plan.
                                   11-5

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11.2        Detailed Description of the Research Initiatives




            (Not Applicable.)








11.3        Timing and EPA Funding of Research Initiatives



            (Not Applicable.)








11.4        Monitoring and Coordination




            EPA will closely participate with the IKLG subgroup on




noise, in assessing the total body burden of noise and the interacting




effect of workplace noise with off-the-job exposures.  This group will




try to come up with suitable methods and models to assess the cumulative



noise doses of workers and the differential effects of noise sources on



hearing.  Close coordination will also be maintained with DOD in their




noise exposure assessments.








11.5        Research Initiatives That Will Not Be Undertaken By EPA




            The following Research Initiatives will not be undertaken



during the five-year period due to relatively low priority and the



necessity of obtaining basic human response and health effects informa-



tion before relating to patterns of exposure.



            o     Determine where and when primary exposures occur, and



sources of exposure.



            o     Determine total exposure patterns of different people,



and relate to time/activity profiles.




            o     Relate health effects of noise with different patterns



of exposure (total and interactive effects).
                                   11-6

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                               CHAPTER  12




                         SUMMARY AND INTEGRATION








             The purpose of this chapter is to pull together information




on the proposed Research Initiatives year by year,  so that for any




year, the total array of research activities,  research milestones and




research decision points can be identified, compared, and discussed across




all of the health effects categories.  This overview (as presented in




Sections 12.1, 12.2* and 12.3*) will then set the stage for interrelating




the proposed Health Effects Research Plan with the core EPA Noise Control




Program Plan throughout the five-year period.   The interrelation between




the two Plans will be discussed in Section 12.4.*  Although the Research




Plan is presented independently,  it is an integral and inseparable part




of the EPA Program Plan.  The Research Plan provides for the development




and refinement of necessary health effects criteria to support noise




control activities over the Five-Year Plan period and even beyond, when




some of the results of planned research activities started during the




1981-1985 Fiscal Year period are expected.  A projection of research




needs for the following five years, beyond the present Plan, is presented




in Section 12.5.*
*These sections will be included in the next cycle of revisions to the Plan.
                                12-1

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12.1         Integrated Research Initiatives by Fiscal Year




             Figure 12-1 displays Che aggregate funding levels for each




research category per year, from Fiscal Year 1981 through 1985.   Approxi-




mately $10 million of health effects research related to noise will be




undertaken by EPA over the duration of the Plan.




             As shown, the largest share of the research funding will




go to nonauditory physiologic effects research, specifically the effects




of noise on the cardiovascular system.  Funding in this category will




comprise approximately 46 percent of the EPA noise effects research




budget over this period ranging from approximately $570K in 1981 to $1.3




million in 1985.




             These funding levels are dependent upon co-support  from




other agencies to conduct the necessary work within the Five-Year Plan




period.  The assumed level of co-support by other agencies will  increase




the effective size of the nonauditory research budget by 34 percent in




Fiscal Year 1982 and by 77 percent in Fiscal Year 1985.  Thus by 1985,




the total research budget in the category will climb to $2.3 million,




with 43 percent of the funding coming from other agencies.




             The necessity for funding at this level is based on the




potentially great health implications of such effects,  the small amount




of research that has been undertaken in this country thus far, and




the high cost of biomedical research.  These funds will support  Research




Initiatives to assess medically significant physiologic responses due




to noise in experimental animal and human clinical studies, the  first
                                 12-2

-------
to
I
U)
                  o
                  Q
                  I
                      1981
1982
   1983


FISCAL YEAR
1934
1985
                        FIGURE  12-1.  AGGREGATE FUNDING FOR ALL CATEGORIES  BY  FISCAL YEAR

-------
U.S. prospective epidemiological study in this area,  and basic investi-




gations of physiologic effects other than on the cardiovascular system.




             Table 12-1 lists the specific Research Initiatives proposed




to be undertaken by EPA each year across all categories.  Detailed




descriptions of these Initiatives are provided in Chapters 4 to 8.




             Turning to research categories other than the nonauditory




physiologic category, the following budgetary trends and features can be




seen in the research budgets over the Five-Year Plan period.




             Funding in support of sleep disturbance research will require




approximately 23 percent of the research budget over the five-year period




and, therefore, will be the second highest funded research category.




Over 50 percent of the proposed research in this category will address




the long-term health consequences of noise.



             Funding in the area of community and individual response




will constitute approximately 17 percent of the total EPA noise effects




research budget over the next five years.  Social surveys and psycho-




acoustic studies will be conducted in response to EPA needs for more




detailed human response criteria for special noise sources and acoustical




parameters.



             In terms of noise-induced hearing loss research, the pro-




posed EPA research effort will maintain a limited but focused profile




due to the continuing research efforts of other agencies.  Funding will




comprise approximately 7 percent of the total EPA research budget and



will not be higher than $150K in any year.  Research will focus narrowly
                                12-4

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on the incidence of NIHL, wich emphasis on Che contribution of non-




occupational noise environments.




             Funding in support of behavioral, social and performance




effects will not start until Fiscal Year 1983, due to the resource




requirements for funding research in other health effects categories.




Overall, only 7 percent of the total research budget (the same amount




as for NIHL research) will be put towards research in this category,




which will feature the clarification of the adverse role noise plays




in the learning process of children.




             Research in the categories of communication interference,




wildlife, and exposure characterization will not be directly funded




by EPA over the Five-Year Plan period due to resource constraints and




higher priorities.




             It is hoped that other agencies can undertake research




efforts in these areas, which are applicable to general EPA objectives




as defined in Chapter 2.  Accordingly,  Research Initiatives have been




identified in these latter categories for the consideration of the




other agencies.
                                12-5

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FY 81:  1.2 Million
NONAUDITORY PHYSIOLOGIC EFFECTS

    Animal Experimental Studies
        o   Replications and Refinements

    Epidemiologic Studies
        o   Retrospective Analysis

    Human Clinical Studies
        o   Acoustic/nonacoustic Factors
        o   Susceptibility Differences
COMMUNITY RESPONSE

    Specific Sources of Noise:
         o    Construction

    Specific Acoustical Attributes:
         o    Intrusiveness and warning signals
SLEEP DISTURBANCE

    Relationship between field and laboratory data
    on sleep disturbance by noise

    Health Consequences of noise-disturbed sleep
NOISE-INDUCED HEARING

    Parameters of Individual  Sensitivity
         o    Susceptibility  of  Special Populations -
              Children.   (Fels)
         o    Determination of Source  Exposures Causing ITS
              and Assessment  of  Debilitating Consequences.

    Incidence of  NIHL  in  the  U.S. and  Contribution of
    Sociocusis, Presbycusis,  and Occupational Exposures.
EPA Funding of Each
Research Initiative
    $290K


    $100K
    S100K
     $80K

   ($570K)
    $100K


    $100K

   ($200K)




   $ 50K

   $ 50K



   $ 50K

  ($150K)

   $1.2 Million
        TABLE  12-1  FUNDING  OF PLAN BY FISCAL YEAR
                                 12-6

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 FT  82;   51.5 million
EPA Funding of     Total Funding of
 Each Research  Nonaudieory Physiologic
  Initiative     Research Inieiacives
                    with Co-Funding*
NONAUDITORY PHYSIOLOGIC EFFECTS

    Animal Experimental Studies
        o   Replication and refinement

    Epidemiologic Studies
        o   Retrospective Analysis
        o   Prospective Analyses (Phase I)

    Human Clinical Studies
        o   Acoustic/Nonacoustic Factors
        o   Susceptibility Differences
COMMUNITY RESPONSE

     Specific Sources of Noise:
         o    Construction

     Specific Acoustical Attributes:
         o    Intrusiveness
         o    Other Topics
SLEEP DISTURBANCE

    Relationship between field and
    laboratory data on sleep disturbance
    by noise

    Health Consequences of Noise-
    disturbed Sleep

    Acoustic Parameters Related to Sleep
NOISE-INDUCED HEARING LOSS
    Parameters of Individual Sensitivity:
    Susceptibility of Special
    Populations - Children.  (Fels)

    Incidence of NIHL in the U.S.  and
    Contribution of Sociocusis,
    Presbycusis, and Occupational Exposures.

    Refinement of Criteria for Low-level
    Noise Exposures.
  $290K
  $100K
  $130K
  $150K
  $125K

 ($795K)
  $100K
  $100K
  $ 60K
                                            ($260K)
  $100K
  $150K
 $ 50K


 $ 50K
  $290K
  $100K
  $«OOK
  $150K
  $125K

($1065K)
                                              $1.5 million
* It is assumed that approximately $270K will be provided by other agencies.
  This amounts to approximately 34 percent  of EPA's Nonauditory Physiologic
  Effeccs Research Funding of $795K,  or 25  percent of  the combined funding.
     TABLE 12-1   FUNDING OF PLAN BY  FISCAL  YEAR  (cont'd)
                             12-7

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FY 83:   $1.9 Million
EPA Funding of
 Each Research
  Initiative"
NONAUDITORY PHYSIOLOGIC EFFECTS

    Animal Experimental Studies
        o   Acoustic/Nonacoustic Factors
        o   Susceptibility Differences

    Epidemiologic Studies
        o   Prospective Analyses (Phase I)
        o   Special Sub-populations—
            Children
    Human Clinical Studies
        o   Acoustic/Nonacoustic Factors
        o   Susceptibility Differences

    Other Nonauditory Effects
        o   Appraisals
COMMUNITY RESPONSE

    Specific Sources of Noise:
         o    Construction
         o    Other Topics

    Specific Acoustic Parameters
         o    Other Topics
SLEEP DISTURBANCE

    Health Consequences of Noise-
    disturbed Sleep

    Acoustic Parameters Related to Sleep
NOISE-INDUCED HEARING LOSS
    Parameters of Individual Sensitivity:
    Susceptibility of special
    populations - children.  (Fels)

    Incidence of NIHL in the U.S.  and
    Contribution of Sociocusis,
    Fresbycusis, and Occupational Exposures.

    Refine criteria for low-level noise
    exposures.
 BEHAVIOR, SOCIAL AND PERFORMANCE
    Cognitive and Social  Development:
    Noise and School Performance Study

    Behavior/Social Adjustment  to
    Noise
  SIOOK
  $100K
  $500K
  $100K
  5100K
 ($900K)




  $ 35K
 •$150K

  S150K

 ($335K)



  $250K


  $150K

 (S400K)



  $ SOK


  $ SOK



  $ SOK


 (S150K)



  $ 60K

  $ 55K


 (S115K)

  $1.9 Million
   Total Funding of
Nonauditory Physiologic
 Research Initiatives
    with Co-Funding*
      $200K
      $100K
      5550K
      $150K
      $1SOK
      $150K
      $100K

     ($1400)
 *  It is assumed that approximately S500K will  be  provided  by  other agencies.
   This amounts to approximately 56 percent of  EPA's  Nonauditory  Physiologic
   Effects Research Funding of $900K, or 35 percent of the combined funding.
TABLE  J2-1  FUNDING  OF PLAN  BY FISCAL YEAR  (cont'd)

                          12-8

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  FY 84:   $2.4 Million
  NONAUDITORY  PHYSIOLOGIC EFFECTS

      Animal Experimental Studies
          o   Acouscic/Nonacouselc Factors
          o   Susceptibility Differences

      Epidemiologic  Studies
          o   Prospective Analyses
          o   Special  Subpopulations—
              Children

      Human Clinical Studies

          o   Acoustic/Nonacoustic Studies
          o   Susceptibility Differences

      Other Nonauditory  Effects
          o   Appraisal.Selected Studies
  COMMUNITY RESPONSE

      Specific  Sources of Noise

      Specific  Acoustic Attributes
           o   Other Topics


  SLEEP DISTURBANCE

      Health Consequences of
      Noise-Disturbed Sleep

      Acoustic  Parameters Related to Sleep
EPA Funding of
 Each Research
   Total Funding of
Nonauditory Physiologic
                                              Initiative
  SIOOK
  $100K
  $500K
  $100K
  S100K
  $100K

($1000K)



 ,$190K

  S200K

 ($390K)



  S350K


  5150K
      Susceptibility of Sensitive Populations  $100K
      to Sleep  Disturbance by Noise            	
  NOISE-INDUCED  HEARING LOSS
     Parameters of Individual Sensitivity:
     Susceptibility of Special
     Populations - Children.   (Fels)

     Incidence  of NIHL in the U.S. and
     Contribution of  Sociocusis, Presbycusis,
     and Occupational Exposures.

     Refinement of Criteria  for Low-level
     Noise Exposures.
  BEHAVIOR,  SOCIAL AMD PERFORMANCE
     Cognitive and Social Development:
     Noise  and School Performance Study

     Behavior/Social Adjustment to
     Noise
 ($600K)



  $ 50K


  $ 50K



  $ 50K


 (S150K)



  $150K

  $110K
                 Research Initiatives
                    with Co-Funding*
      $200K
      $100K
      $600K
      S150K
      515DK
      S150K
      S300K

    (S1650K)
                                              2.4 million
  * It  is  assumed  that approximately $650K will be provided by other agencies.
    This amounts to 65 percent of EPA's Nonauditory Physiologic Effects  Research
    Funding of $1000K,  or 39  percent of  the combined funding.

TABLE  12-1   FUNDING OF PLAN BY  FISCAL YEAR  (cont'd)

                            12-9

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   FY. 85!  $3.0 Million
  NONAUDITORY PHYSIOLOGIC EFFECTS

      Animal Experimental Studies
          o   Acoustic/Nonacouscic Factors
          o   Susceptibility Differences
EPA Funding of
 Each Research
   Total Funding of
Nonauditory Physiologic
                                               Initiative
  $100K
  S150K
      EpldemLologic Studies
          o   Prospective Analyses (Phase I)    S400K
          o   Prospective Analyses (PHase II)     —
          o   Special Subpopulacions—         $1SOK
              Children
      Human Clinical Studies
          o   Acoustic/Nonacoustic Studies
          o   Susceptibility Differences

      Other Nonauditory Effects
          o   Selected Studies
  COMMUNITY RESPONSE

      Specific Sources of Noise

      Specific Acoustic Attributes
           o    Other Topics


  SLEEP DISTURBANCE

      Health Consequences of
      Noise-Disturbed Sleep
  SIOOK
  SIOOK
  $300K

($1300K)



  S250K

  S250K

 ($500K)



  $450K
      Susceptibility of Sensitive Populations  $100K
      to Sleep Disturbance by Noise
      Adaptation to Sleep Disturbance by
      Solas

      Acoustical Parameters Related  to Sleep
  NOISE-INDUCED HEARING LOSS
      Parameters of Individual Sensicivlcy:
      Susceptibility of Special
      Populations - Children.   (Pels)

      Incidence of  5IIHL In the U.S.  and
      Contribution  of  Sociocusis, Presbycusis,
      and Occupational Exposures
  BEHAVIOR,  SOCIAL AND PERFORMANCE

      Behavior/Social Adjustment to Noise

      Cognitive and Social Development:
      Noise and School Performance
  ?150K


  S 50K

 (S750K)



  $ 50K


  $ 50K



 (SIOOK)



  S250K

  SIOOK

  $350K

  S3.0 Million
                 Research Initiatives
                    with Co-Funding*
      $250K
      $100K
                      $SOOK
                      S150K
      S200K
      S150K
      S950K

     (S2300K)
  * It is assumed  that  approximately  $1000Kuill be provided by other agencies.
    This amounts  to  approximately  76 percent of EPA'3 Nonauditory  Physiologic
    Effects Research Funding of  $1300Kf or 43 percent of the combined funding.


TABLE  12-1   FUNDING OF PLAN BY  FISCAL  YEAR  (cont'd)
                                    12-10

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