- Email: [email protected]
EPA as a public health agency
REGULATORY
TOXICOLOGY
AND
PHARMACOLOGY
8,328-334 (1988)
EPA as a Public Health Agency BERNARDD.GOLDSTEIN Department ofEnvironmental and Community Medicine, UMDNJ-Robert Wood Johnson Medical School, Busch Campus, Piscataway, New Jersey 08854
Received January 14,1987
Much of EPA’s actions are driven by concerns for public health. The public’s perception of the potential adverse consequences to their health of chemical and physical agents in the general environment is a common motivating force in setting EPA’s agenda and in making regulatory decisions. Despite its responsibilities in public health, and the major role that public health plays in its decision making, EPAis not part of the Department of Health and Human Services, the federal cabinent-level department with primary responsibility for human health. Rather, EPA is an independent agency with its own Administrator who is the decision maker for over a dozen legislative acts, many of which are based on public health concerns. For very few of these laws is there more than a minimal tie to the activities of classic public health agencies in the Department of Health and Human Services. Unfortunately, this organizational approach has led to a relative lack of individuals trained in the discipline of public health which hinders EPA’s ability to approach public health problems. While there are many good reasons to keep EPA a separate entity from the Department of Health and Human Services, it is imperative there be close coop eration between EPA and the appropriate units of the U.S. Public Health Service. Most importantly, the number of people within EPA who are trained in public health disciplines must be increased As a corollary there must be a concerted effort to educate students in a manner responsive to the need for public health manpower at EPA and at State and local agencies active directly or indirectly in environmental health issues. @198sAcademic press hc.
The impact of environmental factors on disease has been recognized from the beginning of the practice of public health. Many major advances have been made through understanding and controlling external factors responsible for disease, just as many public health disasters have been caused by the human propensity to foul our environment. The prevention and management of environmental problems has been a core discipline in the teaching of public health since the inception of formal training in this area. At one time the practice of public health by the U.S. Government was unified in the U.S. Public Health Service, or the cabinet department to which it reported. Currently, however, there are other federal organizational components also responsible for environmental controls including OSHA, which has the help of NIOSH, a USPHS component; the Nuclear Regulatory Commission; and EPA, an independent government agency. During a 2-year period ( 1983- 1985) while Assis328 0273-23OOf88 $3.00 Copyright 0 1988 by Academic Press, Inc. All r&btsofrepmduction in any form reserved.
EPA AS A PUBLIC
HEALTH
AGENCY
329
tant Administrator for Research and Development, I had the opportunity to consider from the inside how well EPA functions as a public health organization. My conclusion is that a better understanding by EPA employees of the basic tenets of public health would be advantageous to the agency’s function. The Environmental Protection Agency was organized by Presidential act in 1970 in response to growing public awareness of the threat to health and to the general environment posed by toxic chemicals. The agency was an amalgamation of 15 organizational units, primarily from the Department of Interior, the Department of Agriculture, and the U.S. Public Health Service. At its beginning, EPA had 5791 employees, of whom 2265 were from HEW and 650 were Commissioned Officers. Presently, EPA has a total of close to 14,000 employees, including about 240 USPHS commissioned officers. At the professional level, the new employees primarily have come from backgrounds in law, policy, and economics. This dilution of its base of employees trained in public health is a major reason for the difficulty that EPA often has in identifying and applying generally accepted principles of public health. What follows are three examples, briefly considered, in which the lack of a basic public health approach to an environmental problem was originally evident. ASBESTOS
IN SCHOOLS
One of the classic tenets of public health is that people do make mistakes. Events do not always follow plan; accidents happen. Even in a medical setting, where there is a one to one relationship between doctor and patient, and even when increased risk due to failure to comply is known and understood by the patient, compliance with physician instruction is poor. The public health practitioner, dealing with entire populations, automatically assumes inadvertent occurrences, or compliance failures, as being part of the human condition which must be taken into account in planning. Unfortunately, lawyers and regulators do not seem to have learned this important lesson. They tend to approach public health problems with the same concepts that are used for unwanted social activity or for regulating the stock market. If you do not follow the rules, we fine you, or we send you to jail. An example of this problem occurred early in the action taken to remove asbestos from schools. Asbestos is a known human carcinogen that has been used extensively in construction, particularly after World War II when the baby boom resulted in the building of much new classroom space. Normal wear and tear on these buildings have since led to situations in which asbestos-containing materials have become friable, spreading potentially cancer-causing asbestos fibers throughout the school. As this mineral fiber is in essence indestructable, normal activity, such as simply walking, will result in loose asbestos again entering the breathing zone. Removal of this dangerous material must be done very carefully by professionals so as to not increase the risk to building occupants, as well as to workers who are engaged in the asbestos removal. When EPA initially began to attack this important problem, its approach was almost purely from the regulatory legalistic side. The recognition by EPA of the potential danger of asbestos in schools led to the usual round of meetings concerning what should be done about it and an eventual spate of regulation writing. These regulations covered a wide range of desired activity including investigation for the presence of
330
BERNARD
D. GOLDSTEIN
asbestos, the notification of the community, and the removal of the material. School authorities that did not handle the problem according to the regulations would presumably be fined, or have other manifestations of federal displeasure visited upon them. Unfortunately, in their initial approach, the regulation writers almost completely ignored the dangers of ineffective asbestos removal. Obvious questions of importance to the success of the proposal in reducing risk from asbestos do not appear to have been asked initially. For example, were there sufficient individuals trained in the safe and proper removal of asbestos to respond to the inevitable demand by local communities that asbestos be removed? It required a major effort within the agency by individuals with a public health orientation to shift the emphasis from writing the regulations to focusing on means to ensure that the asbestos was safely and effectively removed or contained. Part of this effort was a model risk assessment in which it was assumed that of 10 equal schools, 9 had a 99% effective decrease in the asbestos risk while 1, because of poor removal practices, a lo-fold increase in the extent of asbestos exposure. To the regulation writers this 90% compliance rate sounded very good. However, the numerical calculation showed that the lo-fold increase in risk in 1 school more than overshadowed the gains in the other 9 so that the total risk for the 10 schools would be worse than if nothing had been done at all in any of them. In short time senior management at EPA recognized the need for an agressive approach to assure that actions taken by the public in response to EPA’s Asbestos in Schools Program were totally in keeping with the goal of reducing risk due to asbestos. This has led to an emphasis on dissemination of information at the local level and a quality assurance role rather than acting as a policeman. GASOLINE
MARKETING
A second example of the difficulty EPA personnel have in formulating action plans in a manner consistent with basic public health principles can be observed in the approach currently being taken to the issue of controlling gasoline fumes at the service station. In this case a primary preventive option was considered on equal footing with a secondary preventive option, in contradiction to central principles of public health. Simply stated, public health approaches can be divided into three types: the primary approach is that of total prevention of the risk, the secondary approach is to deal with an identified problem by cleaning it up or in some other way preventing human exposure, and the tertiary approach is to treat those who have been affected so as to mitigate any eventual damage (Last, 1986). It is basic public health doctrine that primary prevention is greatly preferable to secondary prevention and that the tertiary approach, often requiring medical care, represents a failure of public health preventive measures. Individuals trained in public health will automatically choose a primary preventive measure over a secondary and a secondary over a tertiary. However, in the consideration of the appropriate gasoline control strategy at gasoline stations initial discussions did not put the burden of proof on a secondary measure in comparison with a primary. The background for this example is as follows. Total hydrocarbons were listed as a primary air quality pollutant under the original Clean Air Act in 1970 because, along
EPA
AS A PUBLIC
HEALTH
AGENCY
331
with oxides of nitrogen, they are the precursors for the formation of photochemical smog. The primary air quality standard for hydrocarbons has been since withdrawn, on the basis that control of ozone in essence requires the control of hydrocarbon emissions, and so an additional ambient standard was unnecessary. The failure to meet the ozone standard in many areas in this country has required increasing restrictions on the emissions of hydrocarbons. In the past few years studies of sources of hydrocarbons in areas which exceed the ozone standard have shown that a major unregulated source of emissions is through the marketing of gasoline at local gasoline stations. Every day literally millions of Americans fill their gasoline tanks. Evaporation from gasoline spilled during this process and the release of gasoline fumes from the tank being filled has a substantial impact on the eventual formation of ozone through the photochemical process. More recently, two additional rationales for the control by EPA of gasoline emissions at local service stations have developed. One is that benzene, a cause of human leukemia for which control regulations under Section 112 of the Clean Air Act were promulgated in 1983, is a component of gasoline making up approximately 1% of total gasoline hydrocarbons. The second relatively new reason for control is the finding that unleaded gasoline produces kidney tumors in male rats (Gibson and Bus, 1986). Using the methodology of quantitative risk assessment, the risk of cancer from exposure to gasoline fumes can be calculated and the resultant information included in the rationale for control, particularly at the gasoline station which is the major source of public exposure (Anderson et al., 1983; Goldstein, 1985). There are two major forms of technology available for the control of gasoline fumes during the pumping process at the gas station. One option is to modify the automobile in such a way that fumes released while fuel is being put into the gas tank will be captured automatically within the automobile; known as the on-board approach. The main alternative, known as Stage 2, is to put a device on the fuel pump nozzle in such a way as to trap potential emissions during refueling. The impact of EPA’s decision on this matter will include hundreds of millions of dollars in cost to either the automobile industry or the petroleum marketing industry, both powerful and well-organized lobbying groups. The net effect to the consumer will be an increased price either for the automobile or for gasoline. As can be imagined, the EPA has not taken this issue lightly. Discussion of this issue within EPA led to the preparation of option papers presenting the arguments for or against each of the major approaches on the usual bases of economics, politics, health impact, technical feasibility, and other pertinent policy considerations. What was not evident was a priori consideration of the issue from the classic public health viewpoint in which the primary preventive measure of altering the automobile, which could be done under inspection at a handful of new car factories, deserves first consideration in preference to the secondary prevention approach which depends upon the actions of tens of thousands of gasoline station owners and attendants and literally 100 million Americans to appropriately maintain and use devices on the nozzle of a gasoline pump. Let me immediately emphasize that in this case the secondary preventive device may in fact be desirable due to factors including the greater rapidity of installation and the possibility of localizing the regulatory approach to those areas of the country which have an ozone problem. However, what was not done at the outset was to
332
BERNARD
D. GOLDSTEIN
analyze these two options in a way which would put the burden of proof on those arguing for the secondary preventive measure over the primary. Rather, the two options were lined up parallel to each other. Let me also emphasize that the right action from a public health point of view is very likely to be the final recommendation. This is because Lee Thomas and senior EPA staff have devoted a major effort to scrutinizing all of the ins and outs of this difficult issue, and because Administrator Thomas has clearly shown himself to be highly concerned with public health in his decisions. However, it is my belief that there was much time and effort wasted because the approach to this issue was not based on central public health principals which would have immediately put the options in the appropriate context and facilitated decision making.
PRIORITY
SETTING
Another example in which there is a potential problem because of the failure to distinguish between primary and secondary prevention concerns the use of risk assessment as a tool to set agency priorities and distribute resources. The current focus at EPA, and other federal health regulatory agencies, is on the management of risk. EPA’s senior management would undoubtedly equate managing risk with preventing harm. However, there is a subtle distinction between these two terms which is often not understood and can lead to misguided approaches. An example is the use of risk numbers as a means to guide agency priorities. At first glance this would seem to be a good idea and completely consistent with public health practices: EPA should compute risks of effects for all chemicals and across all media; and based upon these risks the agency should assign budget priorities so as to be sure that the major attention is placed on those situations of greatest risk to the American public. The problem with this approach is that it can be counter productive because it again fails to make the distinction between primary and secondary prevention. For one to compute a risk in the way usually done at EPA, there already must be exposure. In other words, dealing with that risk is a form of secondary prevention. Inevitably, if one uses risk assessment as a primary means of distributing agency budget and attention, those agency activities involving primary prevention, for example, registration of chemicals under the Toxic Substance Control Act, will receive an inappropriately small priority level. This is because it is much easier to estimate the numerical risks associated with situations in which an agent is already present than it is for risks that have been completely prevented from ever occurring. The Toxic Substance Control Act inhibits industry from developing those chemicals which might lead to adverse effects upon human exposure. There is a legitimate argument as to the degree of success of this Act. However, it is close to impossible to obtain reasonable estimates of the likelihood that were it not for the activities of EPA under TOSCA, or similar acts, new chemicals would have developed that would by now have produced adverse effects which could be numerically depicted. Accordingly, the reliance on risk estimates to guide agency budgetary priorities would lead to a significant underfunding of the more important primary preventive activities.
EPA
AS A PUBLIC
HEALTH
AGENCY
333
IMPLICATIONS Please note that my criticisms are not an argument for a return of EPA to the USPHS or to HHS. EPA’s responsibilities are not limited to human health; in fact its lasting legacy may well be more in its impact on our natural environment than its direct impact on human health. Nor would I suggest that part of EPA be split off to HHS: this would just perpetuate the mistake made in separating NIOSH and OSHA (consider whether EPA or OSHA has done a better job in promulgating health-based regulations during their 15 years of parallel existence). Further, it would significantly hamper an integrated regulatory approach to chemical agents capable of harming the general environment as well as human health. Rather, what is needed is a concerted effort on the part of EPA to hire individuals educated in public health and to provide public health training to present employees. The same is true at the state level where, for the most part, there is poor cooperation between Departments of Health and Departments of Environmental Protection and less of an impact of the public health outlook on the latter organizations than is desirable. What also is needed is a stronger effort on the part of academic public health programs to prepare professionals for careers in environmental protection and to be more flexible in the provision of coursework for individuals already employed in the field. Schools and Programs of Public Health must be far more aggressive in developing expert and exciting programs in environmental health. The Department of Health and Human Services could be helpful in a number of ways, including continuing to actively support the National Institute of Environmental Health Sciences which has been of great value to EPA’s ability to identify, understand, and appropriately regulate potential problems. The Agency for Toxic Substances and Disease Registry, now under the aegis of CDC, must be able to continue to work closely with EPA in a collegial fashion that does not leave EPA in the impossible situation of hearing two voices about the health basis for its actions. Finally, HHS must reverse its current policy of actively discriminating against USPHS Commissioned Officers serving at EPA in terms of promotion to higher ranks. This policy reneges on the assurances given by USPHS at the time of the formation of EPA and is a major reason that capable senior USPHS officers leave EPA. Further, none of my discussion should be construed as a statement that current EPA actions are contrary to the principles of public health. In fact, in each of the examples cited EPA has acted, or I am confident will act, in the final event in a manner consistent with these principles. However, this to a large extent is because current EPA management has consistently thought through these difficult issues and arrived at answers which were in the best interest of the public. In a sense, the outcome of this thought process by senior officials concerned with protecting the health of the public validates basic public health principles. The lack of a consistent public health outlook, or of sufficient individuals trained in the principles of public health, causes much time and effort to be wasted during the long process of arriving at a decision. At present, EPA does not have the instincts of a public health organization, nor the insight. To correct this, it is necessary to increase the numbers of EPA employees trained in public health or public health related disciplines. We need people who understand that regulation is not the only remedy. Ideally, the Agency should be permeated with the principles of public health so that even those actions that are
334
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made without intensive scrutiny automatically health practice.
are consistent with the best public
REFERENCES E. L., AND the Carcinogen Assessment Group of the U.S. Environmental Protection Agency (1983). Quantitative approaches in use to assesscancer risk. Risk Anal. 3,277. GIBSON, J. E., AND Bus, J. S. (1986). Current perspectives on gasoline light hydrocarbon induced male rate nephropathy. Ann. N. Y. Acad. Sci. GOLDSTEIN, BERNARD, D. (1985). Risk assessment and risk management of benzene by the Environmental Protection Agency. Risk Quantitation and Regulatory Policy. Banbury Report, pp. 293-304. Cold Spring Harbor Laboratory, Cold Spring Harbor, New York. LAST, JOHN, M. (Ed.) ( 1986). Public Health and Preventive Medicine, 12th ed. Appleton-Century-Crofts, Norwalk, CT. ANDERSON,
TOXICOLOGY
AND
PHARMACOLOGY
8,328-334 (1988)
EPA as a Public Health Agency BERNARDD.GOLDSTEIN Department ofEnvironmental and Community Medicine, UMDNJ-Robert Wood Johnson Medical School, Busch Campus, Piscataway, New Jersey 08854
Received January 14,1987
Much of EPA’s actions are driven by concerns for public health. The public’s perception of the potential adverse consequences to their health of chemical and physical agents in the general environment is a common motivating force in setting EPA’s agenda and in making regulatory decisions. Despite its responsibilities in public health, and the major role that public health plays in its decision making, EPAis not part of the Department of Health and Human Services, the federal cabinent-level department with primary responsibility for human health. Rather, EPA is an independent agency with its own Administrator who is the decision maker for over a dozen legislative acts, many of which are based on public health concerns. For very few of these laws is there more than a minimal tie to the activities of classic public health agencies in the Department of Health and Human Services. Unfortunately, this organizational approach has led to a relative lack of individuals trained in the discipline of public health which hinders EPA’s ability to approach public health problems. While there are many good reasons to keep EPA a separate entity from the Department of Health and Human Services, it is imperative there be close coop eration between EPA and the appropriate units of the U.S. Public Health Service. Most importantly, the number of people within EPA who are trained in public health disciplines must be increased As a corollary there must be a concerted effort to educate students in a manner responsive to the need for public health manpower at EPA and at State and local agencies active directly or indirectly in environmental health issues. @198sAcademic press hc.
The impact of environmental factors on disease has been recognized from the beginning of the practice of public health. Many major advances have been made through understanding and controlling external factors responsible for disease, just as many public health disasters have been caused by the human propensity to foul our environment. The prevention and management of environmental problems has been a core discipline in the teaching of public health since the inception of formal training in this area. At one time the practice of public health by the U.S. Government was unified in the U.S. Public Health Service, or the cabinet department to which it reported. Currently, however, there are other federal organizational components also responsible for environmental controls including OSHA, which has the help of NIOSH, a USPHS component; the Nuclear Regulatory Commission; and EPA, an independent government agency. During a 2-year period ( 1983- 1985) while Assis328 0273-23OOf88 $3.00 Copyright 0 1988 by Academic Press, Inc. All r&btsofrepmduction in any form reserved.
EPA AS A PUBLIC
HEALTH
AGENCY
329
tant Administrator for Research and Development, I had the opportunity to consider from the inside how well EPA functions as a public health organization. My conclusion is that a better understanding by EPA employees of the basic tenets of public health would be advantageous to the agency’s function. The Environmental Protection Agency was organized by Presidential act in 1970 in response to growing public awareness of the threat to health and to the general environment posed by toxic chemicals. The agency was an amalgamation of 15 organizational units, primarily from the Department of Interior, the Department of Agriculture, and the U.S. Public Health Service. At its beginning, EPA had 5791 employees, of whom 2265 were from HEW and 650 were Commissioned Officers. Presently, EPA has a total of close to 14,000 employees, including about 240 USPHS commissioned officers. At the professional level, the new employees primarily have come from backgrounds in law, policy, and economics. This dilution of its base of employees trained in public health is a major reason for the difficulty that EPA often has in identifying and applying generally accepted principles of public health. What follows are three examples, briefly considered, in which the lack of a basic public health approach to an environmental problem was originally evident. ASBESTOS
IN SCHOOLS
One of the classic tenets of public health is that people do make mistakes. Events do not always follow plan; accidents happen. Even in a medical setting, where there is a one to one relationship between doctor and patient, and even when increased risk due to failure to comply is known and understood by the patient, compliance with physician instruction is poor. The public health practitioner, dealing with entire populations, automatically assumes inadvertent occurrences, or compliance failures, as being part of the human condition which must be taken into account in planning. Unfortunately, lawyers and regulators do not seem to have learned this important lesson. They tend to approach public health problems with the same concepts that are used for unwanted social activity or for regulating the stock market. If you do not follow the rules, we fine you, or we send you to jail. An example of this problem occurred early in the action taken to remove asbestos from schools. Asbestos is a known human carcinogen that has been used extensively in construction, particularly after World War II when the baby boom resulted in the building of much new classroom space. Normal wear and tear on these buildings have since led to situations in which asbestos-containing materials have become friable, spreading potentially cancer-causing asbestos fibers throughout the school. As this mineral fiber is in essence indestructable, normal activity, such as simply walking, will result in loose asbestos again entering the breathing zone. Removal of this dangerous material must be done very carefully by professionals so as to not increase the risk to building occupants, as well as to workers who are engaged in the asbestos removal. When EPA initially began to attack this important problem, its approach was almost purely from the regulatory legalistic side. The recognition by EPA of the potential danger of asbestos in schools led to the usual round of meetings concerning what should be done about it and an eventual spate of regulation writing. These regulations covered a wide range of desired activity including investigation for the presence of
330
BERNARD
D. GOLDSTEIN
asbestos, the notification of the community, and the removal of the material. School authorities that did not handle the problem according to the regulations would presumably be fined, or have other manifestations of federal displeasure visited upon them. Unfortunately, in their initial approach, the regulation writers almost completely ignored the dangers of ineffective asbestos removal. Obvious questions of importance to the success of the proposal in reducing risk from asbestos do not appear to have been asked initially. For example, were there sufficient individuals trained in the safe and proper removal of asbestos to respond to the inevitable demand by local communities that asbestos be removed? It required a major effort within the agency by individuals with a public health orientation to shift the emphasis from writing the regulations to focusing on means to ensure that the asbestos was safely and effectively removed or contained. Part of this effort was a model risk assessment in which it was assumed that of 10 equal schools, 9 had a 99% effective decrease in the asbestos risk while 1, because of poor removal practices, a lo-fold increase in the extent of asbestos exposure. To the regulation writers this 90% compliance rate sounded very good. However, the numerical calculation showed that the lo-fold increase in risk in 1 school more than overshadowed the gains in the other 9 so that the total risk for the 10 schools would be worse than if nothing had been done at all in any of them. In short time senior management at EPA recognized the need for an agressive approach to assure that actions taken by the public in response to EPA’s Asbestos in Schools Program were totally in keeping with the goal of reducing risk due to asbestos. This has led to an emphasis on dissemination of information at the local level and a quality assurance role rather than acting as a policeman. GASOLINE
MARKETING
A second example of the difficulty EPA personnel have in formulating action plans in a manner consistent with basic public health principles can be observed in the approach currently being taken to the issue of controlling gasoline fumes at the service station. In this case a primary preventive option was considered on equal footing with a secondary preventive option, in contradiction to central principles of public health. Simply stated, public health approaches can be divided into three types: the primary approach is that of total prevention of the risk, the secondary approach is to deal with an identified problem by cleaning it up or in some other way preventing human exposure, and the tertiary approach is to treat those who have been affected so as to mitigate any eventual damage (Last, 1986). It is basic public health doctrine that primary prevention is greatly preferable to secondary prevention and that the tertiary approach, often requiring medical care, represents a failure of public health preventive measures. Individuals trained in public health will automatically choose a primary preventive measure over a secondary and a secondary over a tertiary. However, in the consideration of the appropriate gasoline control strategy at gasoline stations initial discussions did not put the burden of proof on a secondary measure in comparison with a primary. The background for this example is as follows. Total hydrocarbons were listed as a primary air quality pollutant under the original Clean Air Act in 1970 because, along
EPA
AS A PUBLIC
HEALTH
AGENCY
331
with oxides of nitrogen, they are the precursors for the formation of photochemical smog. The primary air quality standard for hydrocarbons has been since withdrawn, on the basis that control of ozone in essence requires the control of hydrocarbon emissions, and so an additional ambient standard was unnecessary. The failure to meet the ozone standard in many areas in this country has required increasing restrictions on the emissions of hydrocarbons. In the past few years studies of sources of hydrocarbons in areas which exceed the ozone standard have shown that a major unregulated source of emissions is through the marketing of gasoline at local gasoline stations. Every day literally millions of Americans fill their gasoline tanks. Evaporation from gasoline spilled during this process and the release of gasoline fumes from the tank being filled has a substantial impact on the eventual formation of ozone through the photochemical process. More recently, two additional rationales for the control by EPA of gasoline emissions at local service stations have developed. One is that benzene, a cause of human leukemia for which control regulations under Section 112 of the Clean Air Act were promulgated in 1983, is a component of gasoline making up approximately 1% of total gasoline hydrocarbons. The second relatively new reason for control is the finding that unleaded gasoline produces kidney tumors in male rats (Gibson and Bus, 1986). Using the methodology of quantitative risk assessment, the risk of cancer from exposure to gasoline fumes can be calculated and the resultant information included in the rationale for control, particularly at the gasoline station which is the major source of public exposure (Anderson et al., 1983; Goldstein, 1985). There are two major forms of technology available for the control of gasoline fumes during the pumping process at the gas station. One option is to modify the automobile in such a way that fumes released while fuel is being put into the gas tank will be captured automatically within the automobile; known as the on-board approach. The main alternative, known as Stage 2, is to put a device on the fuel pump nozzle in such a way as to trap potential emissions during refueling. The impact of EPA’s decision on this matter will include hundreds of millions of dollars in cost to either the automobile industry or the petroleum marketing industry, both powerful and well-organized lobbying groups. The net effect to the consumer will be an increased price either for the automobile or for gasoline. As can be imagined, the EPA has not taken this issue lightly. Discussion of this issue within EPA led to the preparation of option papers presenting the arguments for or against each of the major approaches on the usual bases of economics, politics, health impact, technical feasibility, and other pertinent policy considerations. What was not evident was a priori consideration of the issue from the classic public health viewpoint in which the primary preventive measure of altering the automobile, which could be done under inspection at a handful of new car factories, deserves first consideration in preference to the secondary prevention approach which depends upon the actions of tens of thousands of gasoline station owners and attendants and literally 100 million Americans to appropriately maintain and use devices on the nozzle of a gasoline pump. Let me immediately emphasize that in this case the secondary preventive device may in fact be desirable due to factors including the greater rapidity of installation and the possibility of localizing the regulatory approach to those areas of the country which have an ozone problem. However, what was not done at the outset was to
332
BERNARD
D. GOLDSTEIN
analyze these two options in a way which would put the burden of proof on those arguing for the secondary preventive measure over the primary. Rather, the two options were lined up parallel to each other. Let me also emphasize that the right action from a public health point of view is very likely to be the final recommendation. This is because Lee Thomas and senior EPA staff have devoted a major effort to scrutinizing all of the ins and outs of this difficult issue, and because Administrator Thomas has clearly shown himself to be highly concerned with public health in his decisions. However, it is my belief that there was much time and effort wasted because the approach to this issue was not based on central public health principals which would have immediately put the options in the appropriate context and facilitated decision making.
PRIORITY
SETTING
Another example in which there is a potential problem because of the failure to distinguish between primary and secondary prevention concerns the use of risk assessment as a tool to set agency priorities and distribute resources. The current focus at EPA, and other federal health regulatory agencies, is on the management of risk. EPA’s senior management would undoubtedly equate managing risk with preventing harm. However, there is a subtle distinction between these two terms which is often not understood and can lead to misguided approaches. An example is the use of risk numbers as a means to guide agency priorities. At first glance this would seem to be a good idea and completely consistent with public health practices: EPA should compute risks of effects for all chemicals and across all media; and based upon these risks the agency should assign budget priorities so as to be sure that the major attention is placed on those situations of greatest risk to the American public. The problem with this approach is that it can be counter productive because it again fails to make the distinction between primary and secondary prevention. For one to compute a risk in the way usually done at EPA, there already must be exposure. In other words, dealing with that risk is a form of secondary prevention. Inevitably, if one uses risk assessment as a primary means of distributing agency budget and attention, those agency activities involving primary prevention, for example, registration of chemicals under the Toxic Substance Control Act, will receive an inappropriately small priority level. This is because it is much easier to estimate the numerical risks associated with situations in which an agent is already present than it is for risks that have been completely prevented from ever occurring. The Toxic Substance Control Act inhibits industry from developing those chemicals which might lead to adverse effects upon human exposure. There is a legitimate argument as to the degree of success of this Act. However, it is close to impossible to obtain reasonable estimates of the likelihood that were it not for the activities of EPA under TOSCA, or similar acts, new chemicals would have developed that would by now have produced adverse effects which could be numerically depicted. Accordingly, the reliance on risk estimates to guide agency budgetary priorities would lead to a significant underfunding of the more important primary preventive activities.
EPA
AS A PUBLIC
HEALTH
AGENCY
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IMPLICATIONS Please note that my criticisms are not an argument for a return of EPA to the USPHS or to HHS. EPA’s responsibilities are not limited to human health; in fact its lasting legacy may well be more in its impact on our natural environment than its direct impact on human health. Nor would I suggest that part of EPA be split off to HHS: this would just perpetuate the mistake made in separating NIOSH and OSHA (consider whether EPA or OSHA has done a better job in promulgating health-based regulations during their 15 years of parallel existence). Further, it would significantly hamper an integrated regulatory approach to chemical agents capable of harming the general environment as well as human health. Rather, what is needed is a concerted effort on the part of EPA to hire individuals educated in public health and to provide public health training to present employees. The same is true at the state level where, for the most part, there is poor cooperation between Departments of Health and Departments of Environmental Protection and less of an impact of the public health outlook on the latter organizations than is desirable. What also is needed is a stronger effort on the part of academic public health programs to prepare professionals for careers in environmental protection and to be more flexible in the provision of coursework for individuals already employed in the field. Schools and Programs of Public Health must be far more aggressive in developing expert and exciting programs in environmental health. The Department of Health and Human Services could be helpful in a number of ways, including continuing to actively support the National Institute of Environmental Health Sciences which has been of great value to EPA’s ability to identify, understand, and appropriately regulate potential problems. The Agency for Toxic Substances and Disease Registry, now under the aegis of CDC, must be able to continue to work closely with EPA in a collegial fashion that does not leave EPA in the impossible situation of hearing two voices about the health basis for its actions. Finally, HHS must reverse its current policy of actively discriminating against USPHS Commissioned Officers serving at EPA in terms of promotion to higher ranks. This policy reneges on the assurances given by USPHS at the time of the formation of EPA and is a major reason that capable senior USPHS officers leave EPA. Further, none of my discussion should be construed as a statement that current EPA actions are contrary to the principles of public health. In fact, in each of the examples cited EPA has acted, or I am confident will act, in the final event in a manner consistent with these principles. However, this to a large extent is because current EPA management has consistently thought through these difficult issues and arrived at answers which were in the best interest of the public. In a sense, the outcome of this thought process by senior officials concerned with protecting the health of the public validates basic public health principles. The lack of a consistent public health outlook, or of sufficient individuals trained in the principles of public health, causes much time and effort to be wasted during the long process of arriving at a decision. At present, EPA does not have the instincts of a public health organization, nor the insight. To correct this, it is necessary to increase the numbers of EPA employees trained in public health or public health related disciplines. We need people who understand that regulation is not the only remedy. Ideally, the Agency should be permeated with the principles of public health so that even those actions that are
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made without intensive scrutiny automatically health practice.
are consistent with the best public
REFERENCES E. L., AND the Carcinogen Assessment Group of the U.S. Environmental Protection Agency (1983). Quantitative approaches in use to assesscancer risk. Risk Anal. 3,277. GIBSON, J. E., AND Bus, J. S. (1986). Current perspectives on gasoline light hydrocarbon induced male rate nephropathy. Ann. N. Y. Acad. Sci. GOLDSTEIN, BERNARD, D. (1985). Risk assessment and risk management of benzene by the Environmental Protection Agency. Risk Quantitation and Regulatory Policy. Banbury Report, pp. 293-304. Cold Spring Harbor Laboratory, Cold Spring Harbor, New York. LAST, JOHN, M. (Ed.) ( 1986). Public Health and Preventive Medicine, 12th ed. Appleton-Century-Crofts, Norwalk, CT. ANDERSON,