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Cost of Environmental-Related Health Effects: A Plan for Continuing Study (1981)

Chapter: Chapter 5: Issues Related to Administration and Coordination

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Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
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Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
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Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
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Page 107
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
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Page 108
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
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Page 109
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 110
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 111
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 112
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 113
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
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Page 114
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 115
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 116
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 117
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 118
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 119
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 120
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 121
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 122
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 123
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 124
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 125
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 126
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 127
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 128
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 129
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 130
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
×
Page 131
Suggested Citation:"Chapter 5: Issues Related to Administration and Coordination." Institute of Medicine. 1981. Cost of Environmental-Related Health Effects: A Plan for Continuing Study. Washington, DC: The National Academies Press. doi: 10.17226/812.
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Chapter 5 ISSUES RELATED TO ADMINISTRATION AND COORDINATION Public Law 95-623 specifies agencies within the federal government that are to cooperate witch the National Academy of Sciences and the Department of Health and Human Services (DHHS) as the ongoing study is conducted. 1 They are: the Environmental Protection Agency (EPA), the Department of Labor, the Consumer Product Safety Commission (CPSC), the Council of Economic Advisers (CEA), the Council on Wage and Price Stability (COWPS), and the Council on Environmental Quality (CEC). Other entities of the federal government that the Secretary of PHS determines to have appropriate expertise must also be included. However, groups other than federal agencies and health financing groups may have useful data. For example, industry, labor, academic institutions, and private research groups collect relevant data and have particular interests in the goals of the ongoing study. State and local governments collect large amounts of information in the course of carrying out environmental programs.2,3 International sources may be rich for some kinds of information. Various international groups, such as the International Agency for Research on Cancer and other parts of the World Health Organization, collect and analyze data on environmental hazards.4 In addition, certain kinds of epidemiologic studies are conducted in countries such as Sweden and Norway more east ly than in the United States, partially because these countries have individual personal identifying numbers and researchers can link a variety of records for person. ~ Although England does not have identifying numbers, its centralized health system provides a similar advantage, because health and census information can be linked. 5,6, 7 Federal agencies are likely to have a major role in conducting the ongoing study and supplying and using the data and reports. However, the ongoing study's usefulness could be broadened by considering the needs of the various other groups, including public interest and consumer groups and private voluntary health groups, and by insuring that they play an active ro le in the study . -105-

This chapter considers first some of the major factors within the federal bureaucracy that affect the administration and coordination of the ongoing study. In view of these factors, a list of administrative options is presented, although P.L. 95-623 designates DUBS as the lead government agency for conducting the study. A discussion of the special concerns and insights of some speci f i c groups fat lows the discussion o f federal ~ issues. The groups share many of the same problems, such as a need for materials for public education. ISSUES AT THE FEDERAL LEVEL Coordination Among Federa 1 Agenc ie s P.L. 95-623 requires that this planning study deal not only with the substantive issues of environmental hazards and their health costs, but also with the problems anticipated in coordinating the collection of information both by federal agencies and other institutions. On a subject as broad as the impact of environmental factors on health, it is to be expected that the available scientific and economic data will not give a coherent or exact picture of the total problem. Even with the best statistical basis imaginable, administrators and political leaders would still have to exercise much discretionary judgment in making policy decisions in such a difficult arena. But the great mass of statistical data on which scientific analysis must now rely was not collected specifically for the purpose of this study, or by scientists who were concerned with its objectives. The data instead were collected as by-products of various service functions, or to help in research undertaken for other purposes, or to serve as the basis for various environmental and health regulatory programs.2, 3,8 Some of them were provided by private corporations, responding to regulatory demands; others by state and local governments incidental to various programs and purposes; and some by independent scholars following their own lines of interest. The National Center for Health Statistics (NCHS) has issued a document that catalogues some of the various data collection systems that may be useful for environmental health purposes, and its work documents both the importance of various federal systems and some of their deficiencies for the purposes of the proposed ongoing study.8 Even if each of these sources did its job perfectly, according to its own likes and purposes, the result would be less than a systematic and coherent body of information for the purposes of the -106-

ongoing study. This collection of programs is subject to the administrative and political limitations inherent in the U.S. governmental system, which, by design, has never been a completely integrated one and which now relies heavily on contracts with private institutions to carry out its programs.9 The committee cons idered how the future ongoing study might use the statistics produced by this kind of system to answer the difficult questions posed by P.L. 95-623. Should That study undertake to devise ways not only to use the existing statistical data, but also to improve them? If so, how fundamental a set of changes could the committee reasonably propose, considering that too high a standard not only would entail the sacrifice of other values, but also would require major administrative or political changes far beyond the bounds of feasibility? The TOM planning committee suggests that the ongoing study: o identify the major administrative and policy problems that make difficult the provision of an adequate statistical data base o explore the range of measures that could be adopted within the limits of the present administrative and legal system o recommend whatever changes in organization and procedure seem necessary to accomplish the apparent intention of Congress and the administration. Major Problems Policy disagreement General policy or political disagreements make the goals of the proposed study more difficult to attain. There is (1) a desire to expand and improve the available statistical data, as against a desire to reduce the burden of paperwork on public and private institutions;l~l° (2) a desire to provide more effective regulation of environmental hazards and threats to health, as against putting less of a regulatory burden on the economy; 12 and (3 ~ a desire to provide financial support for the necessary research and data collection, as against the current budgetary pressures on the federal government. Confidentiality Issues of confidentiality and privacy abound in these matters. Epidemiologic research is handicapped by the desire of the medical profession and others to protect the privacy of patients. Research data on some problems are almost impossible to collect because those responsible for collecting the information want to protect the privacy of individuals against the exposure that the Freedom of Information Act would make possible. 13 For example, the possible presence of particular genetics traits among groups or -107-

individuals is sometimes considered unsuitable for the public record because of the threat to their employability or insurability. Although some types of data can be modified to enable their use without violating either individual or industrial confidentiality, the modification virtually assures that data from several sources on a person cannot be linked to help identify the causes of disease. Many factors inhibit data sharing, but problems with confidential information are major impediments. Not only are there rules against agencies letting confidential information out of the government, but also strict limits against sharing confidential information among agencies. Recent bills, moreover, have undertaken to guarantee that data collected, for example, in the Bureau of Labor Statistics, would not be made available outside of the collecting agency.l4 Various studies have discussed the problems.5~15-18 In one study, ~ subcommittee of the Toxic Substances Strategy Committee convened by the Council on Environmental Quality, examined the confidentiality provision of 14 major statutes that deal with Pollutants and toxic substances, as well as agency practices based on the statutes.l5,l6 The subcommittee considered confidentiality issues related to interagency data sharing; agency data sharing with contractors' public disclosure of confidential health, safety, and . efficacy data ~ and disclosure of confidential info`-~uation in administrative proceedings. In many ways, these federal laws were deemed inconsistent in their treatment of confidential information, or led to inconsistent interpretation. The subcommittee reported that current federal laws do not appear to permit agencies to share confidential information with the states, nor to assure individuals access to information about chemicals to which they are exposed. However, the general trend in recent legislation, particularly the Toxic Substances Control Act (TSGA) and the Federal Insecticide, Fungicide and Rodenticied Act (FIFRA), is to accord the public more right to confidential information related to health than to g.enera1 confidential information. Several studies and ef forts have been undertaken to facilitate sharing of data among federal agencies.18~19,20 One effort would permit formation of statistical enclaves so that certain federal agencies, such as the Bureau of the Census, the Social Security Administration, the National Center for Health Statistics, and others, could exchange data. Legislative efforts have addressed some of the issues of privacy and confidentiality. Legislation in this area could alter the ability of researchers to obtain information. -108-

o The Paperwork Reduction Act creates within the Office of Management and Budget (OMB) a central Office of Information and Regulatory Af fairs with the authority to review requests that government agencies make for information from the public. 10 Some epidemiologists are concerned that such a bill may limit their research. O A bill introduced in August 1980, (S. 3011~) would have authorized the Veterans' Administration (VA) to approve the re lease of name and address information from VA records systems to qualified non-federal researchers.20 This bill would have permitted use of VA data bases for many epidemiologic studies. These data bases would be useful because they began with a well-defined population that was relatively healthy upon entering service. O The Medical Records Privacy Act, (H.R.5935) and a comparable Senate bill (S.503) sought to protect the confidentiality of health care information and to establish procedures for patients to gain access to their own records.21,22 o The Labor Statistics Confidentiality Act (S.2887), would have assured confidentiality of material the Bureau of Labor Statistics receives under a pledge of confidentiality.14 Differing purposes of data collection The specialized purposes of various programs from which data may be required, and the specialized interests and commitments of the personnel administering the programs, may make it difficult to provide comparable and uniform coverage of information for any such broad effort as the ongoing study. This is in part the result of the different approaches of people who want data for regulatory purposes in contrast to those who want them as a basis for determining how to provide various services, or to provide information for scientific research. Many data also are obtained as by-products of administrative processes. Federal agencies may fai 1 to require their contractors to supply data that can also satisfy regulatory demands, or they may impose standards of data collection that vary widely among areas or are inconsistent with other goals . For example, employees in nuclear energy plants are not required to keep personal records of their radiation exposures--including non-occupational exposures--although their employers are required to keep records of exposures occurring at the works ite . People in various disciplines, such as epidemiology or labor economics, have different perspectives and interests related to the collection of data. As a result, the data collected in diverse disciplines often are not comparable. Also, rapid changes in scientific methodologies and in technological or social programs make it hard to get a fixed data base for purposes of comparability. For example, it is unlikely that the definition of an area around the -109-

Three Mile Island nuclear plant in which only limited population would be permitted was determined with adequate care and consideration of contemporary realities. 23 To answer the questions posed by P.L. 95-623, or, indeed, to provide a basis for environmental or health regulation under existing programs, it is necessary to get data from agencies that have other missions and other priorities. In a per' ad of budgetary pressure they are likely to resist adding to their burdens, especially when the OMB or an appropriations subcommittee may not sympathize with too broad an interpretation of their scientific research interests. State and 1 canal ; n~c~lvement M~nv of the r~ro~ram`:: for the protection of the environment and of the public health are not federal, but are state or local and have wide variation in their policies and administrative effectiveness. Some have been handicapped by difficulties in legal enforcement, as in problems of toxic waste disposal; others are limited by inadequacies in funding or in the quality of their personnel. In dealing with such problems, the federal agencies can do little in such matters without resorting to specific categorical grants, which have their disadvantages and now meet with political opposition. Statutory authority and interagency groups Finally, even though P.L. 95-623 assigned certain responsibilities to the National Center for Health Statistics for issuing guidelines for collecting and compiling environmental health statistics, these are overlapping responsibilities assigned by other statutes to other coordinating authorities, especially the Office of Federal Statistical Policy and Standards, in the Department of Co~erce at present.2,10, 24, 25 If the specific statutory authority and responsibility of a department head comes into conf 1 ict with a more general responsibility for coordination assigned by statutes to a subordinate officer of another department, the coordination is not likely to be very ef fective unless it is supported by the constitutional or political authority of the President or the congressional leadership. On this subject, the President may not be personally involved, and various institutions in his Executive Office may play roles that are not always in harmony. Similarly, various congressional co~nmit~tees and staff institutions are interested in one way or another in this problem, and there is no c lear-cut procedure to resolve their dif ferences . In addition, there are over two dozen interagency groups, some made up primari ly of working scientist s and others of administrators at various hierarchical levels, that have undertaken to work for the improvement of the regulatory process and the data base on which it must be built. 26' 27 Some of these groups and committees have been —110—

set up by statute, others by executive order, others by informal collaboration and agreement. Appendix D lists some of these groups and their major purposes. To put the issue in perspective, it is necessary to recognize that the government deals with many major issues by the use of similarly inexact data, and without a completely unified system of legal authority. It does so by informal methods of cooperation, sometimes on the basis of scientific and professional standards and under the stimulus of scrutiny and criticism by private institutions. Recommended Anuroaches The ongoing study must decide : o how much to rely on cooperation among existing agencies and institutions o how much to propose substantial legislative action or administrative reorganization to develop a better data base for policy decisions. Voluntary cooperation The ongoing study should begin with the more modest approach, identifying those specific problems of environmental pollution or other conditions that the study finds to be of the highest priority. With respect to each of those problems, it should be possible to identify the various sources of statistical information and the difficulties of filling gaps and removing inconsistencies. To the extent that the difficulties can be solved by voluntary cooperation at an administrative or scientific level in the hierarchy, it should be possible to suggest appropriate approaches. Additional actions If consideration of the several higher priority problems suggests that voluntary cooperation is inadequate, several options exist, ranging from reorganizing interagency committees to involving the Executive Office of the President. a) It might be desirable to rationalize the present apparently disorderly structure of interdepartmental and interagency committees. With respect to the several problems that are considered most important, are these committees the right -ones? Are they organized at an appropriate level in the hierarchy, with respect to the distinction between scientific and administrative subject matter? Do they have the required backing of authority if the issues involved require decisions of a regulatory or financial nature? Interagency committees often work well in collaboration on issues of a scientific and professional nature that do not —111—

involve conflicts of agency policies. Where such conflicts exist, the committees may be ineffective unless they are under the effective guidance and direction of higher political authority, and unless that authority is in a position to insist on agreement without being constrained by conflicting statutory requirements or political pressures. As the ongoing study proceeds, it may wish to consider recommending that some part of the Executive Office of the President (perhaps the Office of Management and Budget, or the Office of Science and Technology Policy, or some cooperative arrangement between the two) establish a system for monitoring on a continuous basis the activities of the continuing committees and the temporary interdepartmental task forces that deal with health problems related to the environment. If such an arrangement should be established, it would be more effective to encourage short-tenm and informal committees to operate by consensus rather than to attempt to create committees that might assume that they could exercise actual authority by majority vote, which cannot be expected to carry weight against the main lines of statutory hierarchical authority. b) Special funding arrangements may be necessary. A major source of difficulty may well be the reluctance of agencies to fund the research or data collection required for purposes outside their central statutory responsibilities. This is not necessarily a matter of ill will; it is often a result of constraints enforced by the OMB or appropriations subcommittees. Is it possible to devise ways to pay for the collection of data of high importance through some special fund or special financial procedure? There may be a wide range of possibilities here that need to be explored. For example, OMB may need to create some special procedure in its process of the review of estimates. Or DUBS or EPA may need to be given a special fund for supplementary grants for the production of data of general relevance. Or perhaps agencies involved in the support of general research, such as the National Science Foundation or the National Institutes of Health, might be given control of, or a special advisory relationship to, expenditures from some such special fund. c) Although no specific instance is suggested, the ongoing study may discover programs of data collection that could be administered better if consolidated or transferred from one agency to another. d) On issues such as those noted above, which involve concerns broader than those of individual departments or agencies, the only executive authority available may be that of the Presidency. There is no guarantee, however, of a unity of -112-

approach within the Executive Office. Nor can such unity of approach be mandated effectively by legislation, or realistically be expected to develop as a result of bureaucratic conflict and political controversy. The Regulatory Analysis Review Group and the Regulatory Council, for example, come at the problem from different points of view and with different preoccupations.* The Office of Management and Budget may be concerned from the point of view of the efficiency of the various operating agencies and interagency committees involved, or the reorganization or transfers of programs. The Council of Economic Advisers and the Office of Science and Technology Policy have contributions to make from their professional points of view, under appropriate executive guidance. It is hard to imagine any effective resolution of the problem of encouraging cooperation among agencies without at least broad guidance and support from the President, in collaboration with congressional leadership. me ongoing study may find itself obliged to inquire how much authoritative and cooperative action may be developed. "Under Executive Order 12044, agencies are required to publish semi-annual agendas of all upcoming regulations and to prepare "regulatory analyses" of all regulations projected to have an annual effect on the economy of $100 million or more.l2 These analyses are to include a description of the major alternative ways of dealing with the problems that were considered by the agency, an analysis of the economic consequences of the alternatives, and a detailed explanation of the reasons for choosing one alternative over the others. These analyses are published In the semiannual Calendar of Federal Regulations. President Carter created the Regulatory Analysis Review Group (RARG) to review ten to twenty of these analyses each year. In practice, RARG operates as a joint venture of CEA, COWPS, and OMB.28,29 The Regulatory Council was formed in October 1978 to coordinate federal regulatory policy. The Council consists of the heads of 36 regulatory agencies and is chaired by the Administrator of ~PA. It has taken over and expanded some of the activities required under the regulation review program, such as publication of the semiannual Calendar of Federal Regulations. It has also commissioned studies on assessing benefits of regulation.28,29 -113-

The Process of Administration of the Ongoing Study The planning study committee observes that P.L. 95-623 specifies DHHS as the lead federal government agency for the ongoing study, and the committee considers this an appropriate choice. In Chapter 6 of this report, the committee makes specific recommendations for appropriate administrative arrangements. However, if DHHS were not designated as the lead government agency, other groups within the federal government might serve in that role. Table 5-l briefly lists various possibilities using three approaches: 0 the lead agency approach o the interdepartmental committee approach o the Executive Office of the President approach. The list is not exhaustive. Because of the limitation imposed by P.L. 95-623, the committee has not considered these other possibilities in detail and is, therefore, not prepared to choose among them. Nonetheless, the table may help to point out the contributions that these groups could make to the ongoing study. TABLE 5-1. ADMINISTRATIVE OPTIONS: POSSIBLE ADMINISTRATIVE ARRANGEMENTS WITHIN THE FEDERAL GOVERNMENT FOR THE ONGOING STUDY OF COSTS OF ENVIRO~ENT-RELATED HEALTH EFFECTS I. THE LEAD-AGENCY APPROACH. To arrange continuing cooperative work on an interagency problem, one device is to give some agency with predominant responsibility the lead, and authorize it to organize more or less formally a committee or task force of those agencies concerned. A. At the scientific or professional level. Approach 1. National Center for Health Statistics, (within DHHS) Advantages Most directly con- cerned and best informed; designated in relevant statute as having continu- ing responsibility in field. -114- Disadvantages Lacking in political author- ity over the agencies whose cooperation would be required.

(Approach) 2. National Institute of Environmental Health Sciences, other institutes of the National Institutes of Health, the Centers for Disease Control (CDC). (All these are part of DUBS.) 3. Office of Federal Statistical Policy and Standards, Department of Commerce. Under provisions of Paperwork Reduction Act, to be transferred back to OMB. B. At the political level (Advantages) Has interest and some of necessary expertise. General statutory authority to coordinate statis- tics throughout government. Its functional assignment would perhaps correspond to the purpose of the ongoing study. . (Disadvantages) Lacking in political authority over the agencies whose coopera- tion would be required. In Commerce, needs to rely on OMB for support for enforcement. It is difficult to know whether it would be given the staff and the support to take on such a responsibility. Approach Advantages Disadvantages 4. Secretary of Health and Human Services The Cabinet member, with the status and access to Presidential little time per- support that that venally to devote implies, with the to such inter- heaviest responsi- bilities in this field (Food and Drug Administration (FDA), National Cancer Institute (NCI), CDC, etc.~. Heavy stake in success of effort. -115- Department heads usually have agency efforts; the Secretary would need to delegate responsibility.

(Approach) 5. Administrator of Environmental Protection Agency 6. Other possibilities, but with weaker cases to be made for them: Departments of Agriculture, Energy, Transportation, Labor (Bureau of Labor Statistics, Occupational Safety and Health Administration); Consumer Product Safety Commission; Nuclear Regulatory Commission. (Advantages) The executive with the most exclusive concern for regu- latory effectiveness in this general field. -116- (Disadvanta~es) EPA has been a target of the deregulation movement and may not always have political support from President. Such an agency has less continuity and status than a Cabinet Department.

II. THE INTERDEPARTMENTAL COMMITTEE APPROACH. to assign the ongoing study ~ ~' entity, whether statutory or created ~ informal agreement. Approach 7. The Regulatory Council: This Council, chaired by the Administrator of EPA, was set up by President Carter to staff his Regulatory Reform Program. 8. Interagency Regulatory Liaison Group: This group includes the major federal health and safety regulatory agencies (CPSC, EPA, FDA, OSHA, and, more recently, the Food Safety and Quality Service (FSQS) from - of Through series of working the Department Agriculture). a groups, it aims to coordinate regulatory activities. Advantages It inc. lude s among its members all the princ ipal regulatory agenc ies, inc. lud ing those in heal th and envi ronment, and i t publishes the Calendar of Federal Regulations. With Execut ive Ord er statu s, and suf f icient stat f, it might direct an Ongoing study. Small, flexible. Intere s ted in many areas re lated to the ongoing s tudy. -117- It might be possible to an existing interdepartmental by Precut ive Order or Disadvantages It is cons idered a leader in the pro-regulation side of political cant roversy; future status unce rtain. Al so rather large, and perhaps unwie lay, in membership. Primari ly represents only these five agencies . Lacks ful 1- time staff. Usual ly con- cerned with ., . more spec ~ arc regulatory Issues .

(Approach) 9. Regulatory Analysis Review Group: This group, set up by Presidential action, includes members from the Council of Economic Advisers (CEA) and OMB, most of the regulatory agencies, and interested agencies in the Executive Office. (Advantages) (Disadvantages) The RARG has wide coverage and is guided by powerful groups in the Executive Office of the President--OMB and CEA. It was created to III. THE EXECUTIVE OFFICE OF THE PRESIDENT APPROACH. Even if interagency collaboration is essential, it is often considered desirable to assign the leadership of an enterprise to some part of the Executive Office of the President (EOP). Advantages. The advantages are assumed to be obvious: EOP status implies the support of the President. Disadvantages. The disadvantages are less obvious but equally real: The EOP is now big enough so that the President cannot personally keep in touch with what its several parts are doing; it is subject to internal professional and political conflicts that the President does not have time to moderate and referee; and there is a great deal of criticism from the Departments and from Congress that too many operating functions have been placed in the EOP rather than the Departments. Subject to those general pros and cons, the following should be mentioned: Approach 10. Council on Environmental Quality Advantages Established to symbolize and monitor the environmental activities of federal agencies, this Council might, without straining its original pur- pose, take on the ongoing study; has appropriate expertise. -118- Disadvantages Whether it has the political support and the operational experience, and a staff of sufficient size and diversity, is another question.

(Approach) (Advantages) (Disadvantages) 11. The Domestic Since the abolition It is staffed on Policy Staff of the Domestic a political Council, this basis. staff is the most general purpose policy staff for the President; it is concerned mainly with new policy. 12. Office of The largest and Its own instincts Management most professional are usually nega- and Budget staff in EOP, with Live with respect the most institu- to new enter- tional memory and prises, and it range of influence. is not staffed Its support (mean- with specialists ing the President's in the environ- support in most mental health cases) is essential. field. COORDINATION AMONG VARIOUS GROUPS State and Local Government Involvement* Introduction Although the directive for an ongoing assessment of the costs of environment-related health effects was issued by Congress to federal agencies, other units of government--state and local governments--also should participate. There are two obvious arguments for their inclusion: 1) state and local governments are (or should be) principal users of the data, and 2) they are potential sources of data for the ongoing study. But also, whether in environmental health regulation, public health, natural resource management, or related activities, federal agencies will be relying increasingly on state and local governments to carry out federal mandates in the 1980s. This trend already is apparent in environmental regulation. To a great extent, state agencies implement federal regulations relating to air pollution, wastewater discharges, and hazardous waste disposal.2,30~31 This section is based partially on a workshop for state and local environmental health officials held on March 26, 1980 as part of the TOM planning study. -119-

Moreover, the state and local regulators are the authorities who make decisions daily about closing public water supplies because of contamination, about conditions for issuing permits to allow construction of new smokestacks or new discharges into sewer systems, about standards for public health and safety that states and communities want. State and local officials can serve as users, providers, corroborators, and challengers of the data needed by the ongoing study. Because they often need to make decisions on short notice, these officials have a particularly keen understanding of limitations in existing data, public policies, and regulatory practices. Moreover, they can offer considerable insight into costs to the community and to the larger public from environmental pollution. Data Concerns State and local officials need information about the benefits--including the health benefits--that would result from actions they might take. At present, estimates of potential health benefits are rarely factored into their decisions because the information is unavailable. However, these officials are responsible for directly spending more than half of the public monies spent on environmental quality control.32 Most public expenditures go for water quality control, and most of that is spent locally. According to the Bureau of the Census, local governments directly spent $9.9 billion of the $12 billion spent by governments in FY 1978 for environmental quality control activities.* In some cases, the major information problem facing state officials is a paucity of relevant standards to guide decision making.30~34~35 Something may be known about a hazard, but not in a form that readily converts to human risk under particular circumstances. As an example, many hazardous materials that are permitted to leave industrial stacks are not controlled by any existing or proposed legislation. Often state officials must make decisions quickly with whatever data are available. For example, in California, starting in May 1979, dibromochloropropane (DBCP) was discovered in about 1000 wells that supplied drinking water. Action on these contaminated wells had to be taken even in the absence of hard epidemiologic evidence *These totals do not include various federal expenses, such as those for research. The Council on Environmental Quality reported total public expenditures of $17 billion for pollution abatement activities in FY 1978.33 -120-

relating DBCP concentrations to cancer or other health risks. An "action level" of 1 ppb was set based on OSHA exposure data and body burden estimates.35 Non-federal regulators would like the ongoing study, therefore, to consider the connection between data on health effects and the setting of standards for regulatory purposes. It would be useful if data, collected perhaps primarily for other purposes, were applicable to standard setting. State officials also want data from a study such as the ongoing study to help educate the public about health effects from environmental contaminants. For this purpose, the information should be clear, relatively free of technical jargon, and comprehensible to people who lack extensive technical training. State and local agencies already collect a great deal of data. However, they require either additional federal funds or assistance from other sources, such as nearby universities, to provide broader data bases or to do additional analyses for the ongoing study. Coordination Among Levels of Government The concerns of the ongoing study involve all levels of government, and it should involve officials at the local level, as well as at the state and federal level. Local officials seldom contribute to higher-level decisionmaking, although they frequently must enforce federal and state regulations. But the ties of federal agencies to state and local counterparts for purposes of sharing information and data of the ongoing study will be difficult to make. Each state's governmental structure is different from the next and current environmental organizations within state governments have evolved considerably since their beginning in public health and other departments. Environmental health programs are centralized in some states, such as New Mexico, but are distributed among half a dozen units in other states, such as Arizona and California.36 Environmental programs are found in such varying state entities as the Department of Agriculture, the Department of Health, and the Department of Natural Resources. A recent report listed the location of environmental health programs within each state, and broadly divided the states into four categories, based primarily on the location and degree of centralization of their environmental health programs. No particular organization was deemed preferable.36 Nonetheless, such structural diversity can lead to coordination problems and difficulties in getting information to the appropriate state or local officials. -121-

Environmental Problem Areas l Non-federal regulators can provide the ongoing study with timely sense of the environmental pollution problems that may constitute the starting points for organizing data on health effects. There is fairly consistent agreement about the major environmental pollution issues for the next several years. They include the contamination of water supplies by industrial chemicals and solvents, and air pollution from industry and utility operations, especially in large-scale conversions to coal. In coastal areas, such as Virginia, there is particular concern that people may eat seafood contaminated with toxic chemicals stirred up in dredging. Industry and Labor* Because the ongoing study will include costs of occupational disease, it should be conducted in close consultation with leaders of labor and industry. They will have points of view on the industries, hazards, and health conditions that most require surveillance, and they may also have useful suggestions of study designs for occupational disease surveillance and methods of estimating the costs of occupational illness. To insure participation and representation of these groups, the Secretary of HHS could establish a mechanism for periodic consultation, preferably tripartite in nature, with leaders of industry and labor in the course of the ongoing study. In addition, the ongoing study should consider the possible utility of data sets on occupational hazards, disease, and death that are collected by some industrial firms and by some local, national, and international labor unions. Broad-scale governmental data may underestimate the incidence of non-fata1 diseases and of pre-morbid dysfunctional conditions related to occupational exposures,37,38 but data sets collected by labor and industry may provide more accurate information on the incidence of such conditions.39~44 As the ongoing study encourages analyses of these data, hazardous conditions may be identified rapidly, thereby providing an early opportunity to protect workers and the general population from extensive exposure. A variety of surveillance programs have been developed by labor and industry.39~44 These range in complexity and degree of development from hazard checklists to sophisticated longitudinal *This section draws on a workshop on occupational health surveillance held on April 8, 1980 as part of the TOM planning study. Representatives from government, labor, and industry participated. -122-

noted: computer-based systems that enable direct linkage of exposure data, physical examination results, laboratory determinations, and, ultimately, death certificate data. The shortcomings of labor- and industry-based data must also be o because the data are specific to a firm, or industry, or group of workers, they may not be easily ~generalizable o because many occupational surveillance systems cease coverage at the time of worker retirement, and because most such systems do not follow "early leavers" from an industry, they will tend to underestimate the frequency of diseases with long latency and diseases that occur in vulnerable subgroups of workers who may have been unable to tolerate noxious workplace exposures for more than relatively short time periods. The ongoing study should remain aware of occupational surveillance programs conducted by labor and industry and particularly of innovative developments in the area by means of the aforementioned mechanism of periodic consultation. In addition, special occupational surveillance programs by labor and industry could be encouraged, perhaps by special funding or other inducements. Public Interest Groups* Public interest groups may draw upon the data of the ongoing study for litigation, rule-making petitions, testimony before Congressional committees to advise on new and existing statutory authorities, and for public education. The groups wish to have cost information to make their cases. Even when data about hazards are available, public interest groups realize that they have little chance of effecting change unless they can estimate the costs to society from the continued presence of the hazard of concern. They suggest that the ongoing study set up systems for collecting and analyzing health effects data and health cost data in a coordinated manner. Two major problems limit the access of these groups to government information. One aspect of the access problem deals with confidentiality of data that contain trade secrets. Such data may be couch of the information for this section comes from a workshop attended by representatives of approximately a dozen public interest groups held in Washington, D.C. on January 15, 1980 as part of this TOM planning study. -123-

gathered, for example, under safety requirements for the Resources Conservation and Recovery Act or under TSCA.12~45 It is recognized that the needs of public interest groups for information sometimes conflict with industry's need for confidentiality. Nonetheless, public interest groups need data--and numerical data whenever possible--in order to develop and support their positions. Federal agencies could consider ways to mask (perhaps by aggregation) specific data that would jeopardize competitive standing so that they can be made available to public interest and other groups to analyze and evaluate. A second problem is the difficulty in knowing what data exist and are available, given the vast array of federal agencies collecting relevant data. The ongoing study might consider ways of keeping public interest groups and other groups informed and up-to-date on available data. Data from the ongoing study may have many uses, but public interest groups particularly would like data applicable to educating the public about complex aspects of environmental health issues--the chemistry of pollutants, the health effects of environmental hazards, the economics of pollution and health effects, and, then, the implications for public policy, public regulation, and public administration. The ongoing study would be especially useful to these groups if some part of the resulting publications were directed toward general public education in these matters and widely distributed. Public interest groups also want information on existing and developing methodologies for assessing the extent of the public's risk, including procedures, assumptions, and limitations. Of particular importance are methodologies of identifying and analyzing synergistic effects among the many substances persons encounter. These groups support the ongoing study~s mandate to cover a broad range of health problems, including those of especially susceptible populations. Private Foundations and Voluntary Health Organizations* Private foundations and voluntary health organizations need current information about the burden of disease, particularly of the Organizations queried for this section include: The Arthritis Foundation, the American Medical Association, the Josiah Macy Foundation, the American Cancer Society, the American Heart Association, the American Lung Association, the March of Dimes Birth Defects Foundation, the American Red Cross, the National Center for Health Statistics. -124-

diseases of their special interest. Many such institutions support investigations, and in a few instances have conducted their own investigations into the epidemiology and costs of disease. Few, however, have the resources or technical capability to sustain an independent data source upon which to base fund-raising campaigns, scientific or service program plans, public policy recommendations or materials for health education. These organizations obtain most of their data from existing federal agencies, such as the National Center for Health Statistics and the National Cancer Institute, and from the medical and public health literature. Data on costs of disease are used primarily for fund raising and public policy recommendations. There is little allocation of resources for purposes of developing or refining methodology. In the development of an ongoing study of the costs of the health effects of environmental hazards it would be desirable to have the agreement of these private foundations and voluntary agencies as to the principles and procedures of collection, analysis, and presentation of data. However, they could present their own interpretation of the data. Because the organizations have widely differing technical capabilities in the areas of biostatistics, epidemiology, and health economics, it would not seem practical to construct a formal data subgroup of these organizations. Their advice should be sought, and they should be invited to participate in ongoing study systems in areas of their expertise. International Organizations The study should maintain liaison with major international organizations concerned with environmental aspects of health. These include the World Health Organization (WHO) Division of Environmental Health (Geneva), the WHO D' vision of Occupational Health (Geneva), the WHO International Agency for Research on Cancer (Lyon) , the United Nations Scientific Committee on the Effects of Atomic Radiation (Vienna), the United Nations Environmental Program (Nairobi), the International Atomic Energy Agency (Vienna), the International Commission on Radiological Protection (London), the International Commission on Protection Against Environmental Mutagens and Carcinogens (Leiden), the International Onion Against Cancer (Geneva), the Permanent Commission and International Association on Occupational Health (London), and the Pan American Health Organization (Washington). Of relevance are the annual Yves Biraud Seminars on Environmental Health, held in Taloix, France and sponsored jointly by the Rockefeller and Merieux (Lyon) Foundations. -125-

EDUCATION Aid INFORMATION DISSEMINATION The ongoing study can fill an educational need for various groups by providing data and analyses that are consistent and comprehensible. To the extent that it is successful in meeting these goals, the ongoing study can help to eliminate the confusion that has sometimes resulted from various representations of the burden of illness attributable to environmental factors. ~ The ongoing study can also note other sources of information scattered throughout the private and public sectors. Various efforts are underway to organize information within the federal government related to environment and health, and to disseminate the information widely. Two particularly useful examples are 1) publications of the Task Force on Environmental Cancer, Heart, and Lung Disease;46~47 and 2) the Regulatory Calendar.29~48 The Task Force was established in accordance with Section 402 of P.L. 95--95 (Clean Air Act Amendments of 1977) to recommend and coordinate federal programs concerned with reduction of environmentally related cancer and heart and lung disease. It has published an inventory of relevant research programs in its eight member agencies.47 Of 115 research programs divided among 15 subject categories, only 4 programs are in the category "estimating costs of environment-related illness." The Regulatory Calendar is published semiannually, in May and November, by the Regulatory Council and describes some regulations under development by member agencies.29,48 Subject headings include energy, environment and natural resources, and health and safety. Agencies submit entries to the Calendar according to several criteria, including regulations that have an annual effect on the economy of $100 million or more, those of great public interest, and those that will impose a major increase in costs or prices for individual industries. Each entry contains information on the statement of the problem, alternatives under consideration, summary of costs and benefits, and collaborative efforts related to the problem. The Calendars dated May 1980 and November 1980 have much additional info`~nation.29~48 Indices list approximate dates of future steps related to rulemaking, such as public comment periods or issuance of an Advance Notice of Proposed Rulemaking. Thus, interested groups can use the calendar to plan for their participation in the rulemaking process, starting at the beginning. Furthermore, an appendix provides information about public participation in the regulatory process, indicating those agencies that have funds available for public participants. -126-

REFERENCES Health Services Research, Health Statistics, and Health Care Technology Act of 1978. Public Law 95-623. 42 USC 201. 2. U.S. Department of Commerce. Office of Federal Statistical Policy and Standards. A Framework for Planning U.S. Federal Statistics for the 1980s. Washington, D.C.: U.S. Government Printing Office, July 1978. 3 . National Research Council. Environmental Monitoring. A Report to the U . S . Envi ronmenta 1 Protect ion Agency f ram the Study Group on Environmental Monitoring. Washington, D.C.: National Academy of Sciences, 1977. World Health Organization. International Agency for Research on Cancer. IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Chemicals and Industrial Processes Associated with Cancer in Humans, Volumes 1-20, Supplement 1. Lyon: IARC, September 1979. 5. U.S. Department of Health and Human Servicese National Center for Health Statistics. The Person-Number Systems of Sweden, Norway, Denmark, and Israel. DENS Publication No. (PHS)80-1358. Washington, D.C.: U.S. Government Printing Office, June 1980. 6. Fox, A.J. The Role of OPTS in occupational epidemiology: some examples. Annals of Occupational Hygiene 21:393-403, 1979. 7. Fox, A.J. Prospects for measuring changes in differential mortality. Paper presented at the World Health Organization Meeting on Socioeconomic Determinants and Consequences of Mortality, Mexico City, June 19-25, 1979. - 8. U.S. Department of Health and Human Services. National Center for Health Statistics. Environmental Health: a Plan for Collecting and Coordinating Statistical and Epidemiologic Data ~ . ~30-1248. Washingto :~, D.C.: U.S. Government Printing Office, 1980. 9. Smith, B.L.R. The New Political Economy: The Public Use of the Private Sector. flew York: John WileY and Sons. 1975. 10. The Paperwork Reduction Act of 1980. Public Law 96-511 (December 11, 1980), 94 Stat. 2767. 1 1. Executive Order 12044, Improving Government Regulations . 43 Federal Register, p. 12661, March 24. 1978. —127—

12. See Appendix B of this report: Table of Major Federal Laws Relating to Environmental Quality and Health. 13. The Freedom of Information Act (FOIA)~5 USC 552), as amended in 1974 and 1976, requires agencies to make documents available with some exceptions. U.S. Congress. Senate. S.2887, the Labor Statistics Confidentiality Act. 96th Congress, 2nd Session, 1980. Council on Environmental Quality. Report to the Toxic Substances Strategy Committee by the Subcommittee on Trade Secrets and Data Confidentiality. 1978. Unpublished. 16. Council on Environmental Quality. Toxic Substances Strategy Committee. Toxic Chemicals and Public Protection. A report to the President by the Toxic Substances Strategy Committee. Washington, D.C.: U.S. Government Printing Office, 1980. 17. U.S. Department of Health and Human Services. National Center for Health Statistics. Environmental Health: A Study of the Issues in Locating, Assessing, and Treating Individuals Exposed to Hazardous Substances. DHHS Publication No. (PHS)81-1275. Washington, D.C.: U.S. Government Printing Office, 1981. 18. Federal Statistical System Project Staff. Improving the federal statistical system: report of the President's Reorganization Project for the Federal Statistical System. Statistical Reporter 197-212, May 1980. 19. Beebe, G.W. Record linkage systems--Canada vs. the United States. American Journal of Public Health 70:1246-1248, 1980. 20. U.S. Congress. Senate. S.3011, a bill to amend Title 38 of the United States Code to authorize the Administrator to approve the release of name and address information from Vt records systems for the purpose of bona fide research. 96th Congress, 2nd Session, 1980. 21. U.S. Congress. House. H.R.5935, the Federal Privacy of Medical Information Act, 96th Congress, 1st Session, 1979. U.S. Congress. Senate. S.503, a bill to amend the Privacy Act of 1974 to privide for the confidentiality of medical records. 96th Congress, 1st Session, 1979. Behavioral Effects Task Group. Report of the Public Health and Safety Task Force on Behavioral Effects. In Staff Reports to the President's Commission on Three Mile Island. Reports of the Public Health and Safety Task Force, pp. 257-308. Washington, D.C.: U.S. Government Printing Office, October 1979. -128-

24. Office of Management and Budget. Statistical Policy Division. Statistical Services of the United States Government. Washington, D.C.: U.S. Government Printing Office, 1975. 25. Duncan, J.W. Recent developments in reorganization of statistical policy. Statistical Reporter, 157-167, April 1980. 26. Task Force on Environmental Cancer and Heart and Lung Disease. Directory of Federal Interagency Groups Concerned with Environmental Health. Gaithersburg, MD: GEOMET, Inc., Apri 1 1980. 27. U. S. Environmental Protection Agency. Directory of Federal Coordinating Groups for Toxic Substances, 2nd Edition. Toxics Integration Information Series. EPA-560/13-80-008, March 1980. 28. De Muth, C. C. Regulatory Costs and the Regulatory Budget. R-79-03, KSG No . 75D. Prepared as part of the faculty pro ject on regulation, Kennedy School of Government, Harvard University. December 1979. 29. United States Regulatory Calendar. Calendar of Federal Regulations . Washington, D. C.: U. S . Government Printing Of fice , May 1980. 30. General Accounting Office. Federal-State Environmental . . Programs--The State Perspective ~ CED-80-106. Washington, D. C.: U. S. Government Printing Office, August 22, 1980. 31. Clean Air Act Amendments of 1977. Public Law 95-95. 42 USC 7401 et seq. 32. U. S . Department of Commerce. Bureau of the Census. Environmental Qual ity Contra 1. Governmental Finances: Fi sea 1 Year 1977-78. State and Local Government Special Studies No. 97. Washington, D.C.: U.S. Government Printing Office, 1980. 33. Council on Environmental Quality. Environmental Quality. The Tenth Annual Report of the Council on Environmental Oual ity. Washington, D.C.: U. S. Government Printing (office, December 1979. 34. Gaston, J.M. (California Department of Health Services, Sanitary Engineering Section, Berkeley, CA. ~ Statement submitted to the TOM Workshop for State and Local Environmental Health Officials, held as part of this ION planning study in Washington, D.C., March 26, 1980. 35. Summary of the [California] Department of Health Services Activities Relative to the DECP contamination of Groundwater Supplies. Statement prepared by J.M. Gaston, (California Department of Health Services ~ . Undated . -129-

36. El-Ahraf, A. and Baca, T.E. The administration of state environmental programs--who is responsible? Paper presented at the American Public Health Association Annual Meeting, Los Angeles, CA, October 19, 1978. 37. U.S. Department of Labor. Occupational Injuries and Illnesses in 1979. USDL-80-726. Washington, D.C.: U.S. Department of Labor. News Release, November 20, 1980. 38. U.S. Department of Labor. An Interim Report to Congress on Occupational Disease. Wasington, D.C.: U.S. Department of Labor, June 1980. 39. Dixon, E.M. (Celanese Corporation.) Health Surveillance. Paper presented at meeting of the American Lung Association Occupational Lung Disease Task Force held April 9-11, 1980 in Clearwater Beach, FL. The paper describes the surveillance system being set up by the Celanese Corporation. 40. Hughes, J. (Kaiser Aluminum and Chemical Corporation.) Occupational Health Surveillance Charts; Summary of All Airborne Contaminants and Physical Stresses in Corporate Operations; Medical and Industrial Hygiene Considerations. Charts given to the IOM staff at the occupational health surveillance workshop, held as part of this TOM planning study in Washington, D.C. on April 8, 1980. Hillman, G. (International Business Machines Corporation.) ECHOES: IBM Environmental, Chemical and Occupational Evaluation System. Paper distributed at the occupational health surveillance workshop held as part of the IOM planning study in Washington, D.C. on April 8, 1980. Pell, S. (E.I. du Pant de Nemours and Co.) Discussion paper for the workshop on occupational health surveillance. Paper distributed at the occupational health surveillance workshop held as part of the IOM planning study in Washington, D.C. on April 8, 1980. 43. Pell, S., O'Berg, M.T., and Karrh, B.W. Cancer epidemiologic surveillance in the Du Pant Company. Journal of Occupational Medicine 20:725-740, 1978. 44. Wolford, R.D. and Larson, M.B. (International Brotherhood of Painters and Allied Trades.) Statement related to occupational health surveillance, prepared for the occupational health surveillance workshop held as part of the IOM planning study in Washington, D.C. on April 8, 1980. -130-

45. U.S. Environmental Protection Agency. Office of Toxic Substances. TSCA Confidential Business Information Security Manual. Washington, D.C.: U.S. Environmental Protection Agency, July 1978. 46. Task Force on Environmental Cancer and Heart and Lung Disease. Environmental Cancer and Heart and Lung Disease. Third Annual Report to Congress. Gaithersburg, MD: GEOMET, Inc., August 1 1980. 47. Task Force on Environmental Cancer and Heart and Lung Disease. Report of the Inventory of Federal Research Programs of Relevance to the Task Force. Gaithersburg, MD: GEOMET, Inc., April 1980 48. United States Regulatory Council. Calendar of federal regulations. 45 Federal Register pp. 77701-78116, November 24 1980. -131- - , —

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