environmental risk harmonization: federal/state approaches to risk assessment and management

REGULATORY TOXICOLOGY AND PHARMACOLOGY 25, 158–165 (1997)ARTICLE NO. RT961081

Environmental Risk Harmonization: Federal/State Approachesto Risk Assessment and Management

MICHAEL A. KAMRIN

Institute for Environmental Toxicology, Michigan State University, East Lansing, Michigan 48824

Received December 5, 1996

mend ways to increase consistency among their ap-proaches where appropriate. The meeting also includedAs environmental laws and regulations have evolvedparticipants from the World Health Organization andin recent years, disparities have arisen in the assess-

ment and management of similar risks by different Health Canada for two reasons. One was to providegovernmental units. Such inconsistencies have had an international perspective that addressed externalseveral adverse impacts. One is that resources may not factors that may influence U.S. harmonization efforts.be used most effectively to reduce risks and a second The second was that many of the same issues faced inis that public confidence in government may be eroded the U.S. are also encountered in attempts to harmonizeand thus support for environmental protection. This risk approaches among nations, e.g., members of thearticle presents a summary of a conference and work- European Community.shop that was held to address the sources of these dis- The first day of the meeting was largely devoted toharmonies in risk assessment and risk management presentations by representatives of government orga-and to make recommendations as to how to improve nizations describing the way that each approached riskthe situation. It includes international, national, and assessment and risk management. However, it also in-state perspectives and utilizes a case study to illus- cluded a case study that provided an opportunity totrate the variety of issues associated with harmonizing examine how these approaches have been applied inrisk assessment and risk management among govern-

specific situations and also to illustrate the types ofmental units. The workshop summaries demonstrateinconsistencies that may arise as a result of state andthat, while there are presently many areas of disagree-federal policy differences. In addition, there was a pre-ment, there are also significant issues upon whichsentation and discussion devoted to the impact of riskagreement can be reached and which can serve as thecommunication on harmonization efforts.basis for further harmonization efforts. q 1997 Academic

The second day of the meeting was devoted to fourPress

workshops, each addressing one facet of harmoniza-tion. One addressed toxicity assessment, the secondexposure assessment, the third risk management, andAs a result of the parallel, rather than integrated,the last risk communication. Each group was chargeddevelopment of management strategies to deal withwith answering questions about the desirability andcontamination of the environment during the past halffeasibility of particular harmonization efforts and mak-century, a number of inconsistencies have arisen ining recommendations for steps to take to increase har-the approaches taken by different nations and agenciesmonization where appropriate. A representative ofwithin nations in assessing and managing risks fromeach workshop reported the results of its deliberationsenvironmental contaminants. Some of these inconsis-to the other meeting participants at the end of the daytencies have been the subject of extensive discussion,so that all were able to leave with an appreciation ofe.g., the differences in rules governing the same pesti-areas of consensus as well as unresolved issues relatedcide residues in raw vs processed foods (NRC, 1989).to a number of facets of the harmonization process.However, there are also many other inconsistencies

among and within state and federal agencies that regu-INTERNATIONAL HARMONIZATIONlate the same chemical contaminants.

The purpose of the symposium on the Harmonizationof State/Federal Approaches to Environmental Risk, Cindy Sonich-Mullin, World Health Organization In-

ternational Program in Chemical Safety (IPCS), dis-held on May 20–21, 1996 at Michigan State University,was to examine the approaches currently taken by a cussed harmonization efforts that are ongoing in Eu-

rope. One of the first issues addressed was the funda-number of U.S. federal and state agencies and to recom-

1580273-2300/97 $25.00Copyright q 1997 by Academic PressAll rights of reproduction in any form reserved.

AID RTP 1081 / 6e11$$$$$1 04-16-97 03:51:02 rtpa AP: Reg Tox Pharm

159ENVIRONMENTAL RISK HARMONIZATION

mental question of how harmonization is defined, e.g., liminary estimates indicate a small margin betweenmeasured concentrations and those thought to be asso-as standardization, working within a common frame-

work, etc. The definition that the Europeans decided ciated with risk, sophisticated modeling of exposure isrequired to support decision-making.upon was that harmonization is working toward a con-

vergence of approaches, and not a standardization of The toxicity assessment divides effects into thresholdand nonthreshold, with genotoxic carcinogenesis andapproaches.

The participants in the discussions among Euro- inheritable mutagenicity the only two types of effectsthat fall into the latter category. As a result, a greatpean Union members suggested that the advantages

of concerted and coordinated efforts toward this goal deal of effort has been devoted to interpreting carcino-genicity and mutagenicity data. In general, the Inter-include progress on common classification and labeling

schemes for chemicals, a saving of time and expense national Agency for Research on Cancer (IARC) ap-proach (IARC, 1987) has been adopted, althoughthrough sharing of information, and increased credibil-

ity of the science through peer review. This last advan- Health Canada also allows the inclusion of data onmechanism of action. For nonthreshold substances, notage can further lead to greater accountability in risk

assessments and risk assessment procedures. slope factors or acceptable levels of risk are calculated.An Exposure Potency Index (EPI), comparing esti-However, these discussions also revealed that there

may be great difficulties in achieving harmonization, mated exposure to estimated potency, was developed toassist in establishing priorities for exposure reductionat least in the near future, because of fundamental

differences among nations in their view of the relative options for nonthreshold substances. Exposure is ex-pressed as total daily intake or concentration in theseriousness of various environmental insults and how

they should be dealt with. These differences may be relevant medium. Potency is expressed as the dose orconcentration associated with a 5% increase in cancerreflected in what appear to be strictly scientific ques-

tions such as the definition of an adverse effect. mortality. This approach assumes risk to be a contin-uum as opposed to a point value.Some lessons learned from the initial stages of this

international effort are that harmonization is likely to For substances for which there is a threshold, tolera-ble intakes or concentrations are calculated using ac-be achieved only in a step-wise process and that it is

most likely to be successful as a bottom-up operation. cepted methods; i.e., use of safety factors. However,when appropriate data are available, safety factors willAttempts to dictate from the top appear to be counter-

productive. Another lesson was that whatever ap- be replaced with data-derived correction factors. In ad-dition, it is expected that benchmark doses, based onproaches the parties move toward must include sig-

nificant flexibility in application to accomodate the dif- extrapolations of dose–response data, will be utilizedincreasingly instead of no-effect levels for thresholdferences among nations.

Another international perspective was provided by chemicals.The movement toward the use of the 5% level forKathy Hughes of the Environmental Directorate of

Health Canada. She discussed some novel approaches nonthreshold chemicals and the benchmark dose forthreshold chemicals will lead to a greater ability toto the risk assessment of priority substances developed

in the Directorate. These were developed in response compare the toxicity of chemicals of the two differentclasses. This, in turn, will be very helpful to risk man-to a mandate in the Canadian Environmental Protec-

tion Act to conduct and publish risk assessments of agers who need to establish risk reduction prioritiesnot only within but also between chemical categories.substances that may be a danger to human health or

the environment. The assessment process involves in-ternal and external peer review as well as public com- FEDERAL HARMONIZATIONment.

One unique aspect of the assessment is the estimate David Bennett of the U.S. Environmental ProtectionAgency (EPA) Superfund Program, discussed harmoni-of the relative magnitude of the contribution of each

environmental medium to overall exposure for five dis- zation issues related to remediation of hazardous wastesites, particularly Superfund sites. He also addressedtinct age groups in the population; infants, toddlers,

elementary school children, teenagers, and adults. Av- the definitional question and proposed ‘‘consistency’’ asa synonym for harmonization. He went on to point outerage values for behavioral parameters for each popu-

lation group, e.g., amount of drinking water consumed, that the legislative mandate for Superfund, particu-larly the requirement that clean-ups meet applicableare used in the exposure assessments. As part of this

process, Health Canada is conducting a multimedia or relevant and appropriate criteria (ARARs) promul-gated by a variety of agencies, introduced inconsistencysurvey of homes to provide the data needed to refine

exposure estimates. A stepwise approach is being con- to the process because different agencies have devel-oped different criteria.sidered to separate exposures into categories, e.g., very

low, moderate, and very high. While decisions at the Within this regulatory framework, the EPA hasmade a number of efforts to promote consistency in thehigh and low ends are usually not difficult, when pre-


160 MICHAEL A. KAMRIN

treatment of Superfund sites across the country. These expert group took was to describe in detail the scenar-ios corresponding to each pathway using available datainclude the issuance of guidance manuals for per-

forming site-specific risk assessments (EPA, 1989a, and assumptions agreed on by the group members.These data and assumptions were used to generate1991) that include standard toxicity assessment values

from the EPA Integrated Risk Information System quantitative risk assessments and probabilities of in-sect spread by the various pathways, which were then(IRIS) (EPA, 1993) and standard exposure assumptions

and equations (EPA, 1989b). However, even when such compared. This can be thought of as a sensitivity analy-sis approach. Applying this approach to the case study,documents were used as the bases for assessments,

there remained inconsistencies in application at differ- it was found that 99.8% of the risk was associated withone pathway and thus that risk reduction could beent Superfund sites and further guidance was issued.

This, in turn, led to a problem of overspecification achieved most efficiently by concentrating on managingthe risk through this pathway.and rote use of parameter values that might not be

appropriate for specific sites. As a result, a new ap- This case study showed the usefulness of expertgroups in harmonizing approaches to a particular riskproach represented by the development of soil screen-

ing values has been adopted (EPA, 1996a). These val- situation. It also showed the importance of a compara-tive analysis of risk pathways as opposed to an exami-ues are not meant to be clean-up criteria but instead

to provide a way to distinguish potentially serious situ- nation of each independently. These lessons couldprofitably be applied to chemical as well as biologicalations from ones that do not merit further consider-

ation. risks in most effectively achieving risk managementgoals, whether they be protection of valuable timber orA related harmonization issue is that some states

have been changing their approaches to risk manage- human health.Christopher DeRosa, U.S. Agency for Toxic Sub-ment, e.g., incorporating future land use in clean-up

decision-making. In addition, some states have been stances and Disease Registry (ATSDR) Division of Tox-icology, discussed the ATSDR approach to risk assess-changing the criteria they use for risk acceptability.

This obviously leads to differences in risk management ment with an emphasis on the public health aspects ofthis approach. As is the case with other federal agen-decisions among states even if the same general guid-

ance is used. Another contributor to inconsistencies is cies, the National Academy of Sciences paradigmserves as the basis for ATSDR risk assessment andthe use distributions rather than point estimates to

describe exposure at some sites. risk management. However, in contrast to other agen-cies, the ATSDR describes its evaluations as publicThe more the hazardous waste situation is examined,

the more harmonization issues are identified. In addi- health assessments and uses a tiered methodology thatprioritizes the relative public health significance of dif-tion, the steps taken so far have made it clear that

successfully addressing these issues must involve the ferent hazardous waste sites through a stepwise pro-cess.input of a wide variety of actors, including risk asses-

sors, state agency staff, bankers, insurance people, and The public health assessment is performed using bio-medical information in addition to traditional risk as-environmental groups, to be successful.

Robert Griffin, United States Department of Agricul- sessment data and results in estimates of plausibleranges of human exposure to contaminants from suchture Animal Plant Health and Inspection Service

(APHIS), emphasized the importance of international sites. This information is used as part of a weight ofevidence approach conducted in a peer review process.agreements such as the General Agreement on Tarriffs

and Trade (GATT) and the North American Free Trade In distinction to values calculated by other agencies,the ATSDR generates screening levels (Minimal RiskAgreement (NAFTA) on risk assessment and risk man-

agement. As standards are developed under these trea- Levels) for chemicals in specific media that apply todiffering durations and routes of exposure. These levelsties, they have an impact on U.S. government policies

which, in turn, are reflected at the state level. If actions are used as risk management tools but not as regula-tory values or clean-up standards.in the U.S. are inconsistent with these treaties, they

could have significant effects on U.S. industry and the This approach may lead to different risk manage-ment values than those of other agencies although theU.S. economy.

He also presented a case study involving the spread basic paradigm is the same and the fundamental pur-pose is very similar, i.e., to establish a value belowof a tree pest, the pine shoot beetle, to illustrate the

somewhat different model for approaching risk assess- which adverse effects are not expected to occur. How-ever, the ATSDR approach has the advantage of clearlyment and management that is followed in APHIS. This

model is based on a quantitative assessment of risk specifying the scenario under investigation and so pro-vides the opportunity to understand the sources of in-from all possible pathways using expert groups made

up of representatives from industry and academia as consistencies among agencies.One of the outcomes of using this scheme for prioriti-well as state and federal agencies.

In the pine shoot beetle example, the first step the zation based on exposure has been to reveal the quality



and quantity of data available to make such decisions. challenges to both the risk manager and the risk com-municator.Application to Superfund sites has shown that a sig-

Lead, a naturally occurring substance, provides anificant percentage of these sites are classified as ‘‘Inde-good example of one approach to addressing some expo-terminate Public Health Hazard’’ because of the gapssure issues that were raised. To estimate the range ofin data. In response to this, specific types of data gapsexposures to lead from various food sources, e.g., wine,have been identified, e.g., percentage of chemical ab-a probability distribution of exposure can be con-sorbed through the skin due to soil contact, and re-structed. In doing this, it is important to consider thesearch has been initiated to provide the lacking infor-uncertainties in food source inputs as well as food leadmation.levels. The distribution generated can be compared toThus, the ATSDR approach encourages harmoniza-levels of concern and the risk manager can decide,tion by utilizing the broadest information available.based on these data and other factors, what the accept-This provides those who are performing risk assess-able maximum level in wine should be.ments or risk management a better understanding of

William Farland, U.S. Environmental Protectionthe reasons values they are using may differ from num-Agency National Center for Environmental Assess-bers used by others. In addition, the tiered or screeningment, discussed harmonization efforts at the federalapproach provides an opportunity to develop commonlevel during the past 20 years. A pervasive problem inpriorities and thus a common framework within whichachieving harmonization has been the uncertainties into proceed.assessing the types of risks, their magnitudes, the prob-The impacts of underlying differences in science pol-abilities of their occurrence, and their potential eco-icy, legislative authority, and risk standards on harmo-nomic impacts. The focus in the past has been on risknization were addressed by Michael Bolger, U.S. Foodassessment issues and it should be recognized thatand Drug Administration (FDA) Center for Food Safetysuch issues have had a significant impact on prioritiesand Applied Nutrition. He emphasized that these dif-for research and data collection. Thus, there has beenferences tend to obscure the fact that most agenciesfeedback between assessments and research.use a safety-based risk assessment approach and that

In addition to the problem of uncertainties, harmoni-many similarities in risk assessment approaches existzation efforts have often been strongly affected by theamong agencies.vagaries of the political process. Efforts in the lateIn the case of the FDA, one of the legislative man- 1970s to harmonize risk assessment foundered when adates under which it operates specifies a particular new administration came to power. These efforts werestandard of safety or risk for contaminants in foods. reborn about a decade later in the form of the Federal

This legislation treats naturally occurring toxic sub- Coordinating Council for Science, Engineering andstances, such as mycotoxins, differently from food addi- Technology (FCCSET). FCCSET was successful in in-tives. In addition, it stipulates that the economic mag- troducing some concepts that were incorporated intonitude of possible food loss and the costs of technologi- recently published risk assessment documents and incal changes needed to reduce exposure must also be brokering agreement among agencies as to the mostconsidered in managing contaminants. These legisla- appropriate cross-species scaling factor.tive mandates can lead to disharmonies in risk man- There were a number of seminal documents pub-agement between FDA and other agencies which have lished during the last decade and a half as well. Onejurisdiction over the same chemicals that appear as is the 1983 National Academy volume Risk Assessmentcontaminants in foods. in the Federal Government: Managing the Process

However, even within a general mandate, there are (NRC, 1983), and another is the Office of Science Tech-assessment and management issues that need to be nology and Policy document Chemical Carcinogens: Re-considered. For example, real exposures to foods are view of the Science and Its Associated Principles (OSTP,episodic, while data about toxic effects are based on 1985). The past few years have seen the issuance of aexperiments where exposures occur every day. In addi- number of National Academy of Sciences volumes ontion, the concentrations of contaminants in foods are risk assessment and risk management (NRC, 1993,likely to vary from time to time while experimental 1994, 1996) as well as proposed revisions of the 1985studies are done by administering unvarying daily cancer guidance by the EPA (EPA, 1996b) and morequantities. sweeping suggestions for changes published by the

In addition, there are fundamental difficulties in Commission on Risk Assessment and Risk Manage-comparing different types of health risks, e.g., risks ment (CRARM, 1996).from chemicals vs risks from microbiological contami- A number of common themes can be found in thesenants. Furthermore, nutritional issues may be im- recent documents, reflecting a general movement to-portant when substituting one food for another; this wards greater harmonization of risk assessment. Formay involve trading a contaminant risk for a dietary example, there appears to be agreement on incorporat-

ing and evaluating all relevant information; not justone, e.g., cholesterol. These issues provide significant



data on the most sensitive species or only positive re- analyses of environmental contaminants. Even if thereis commonality in fish consumption data, if the mea-sults. There is a related move toward risk assessment

conclusions that provide much more than a single surements of contaminants in these fish are performeddifferently in different states, this could easily lead tovalue, e.g., a range or at least a context for the single

value. As part of this, the impacts of alternative conclu- conflicting fish consumption advisories. Interlabora-tory consistency is another area that the ATSDR issions provide valuable information to the risk manager.

One last example is an attempt to find a common rubric supporting and steps to improve data collection areunderway.for both carcinogen and noncarcinogen risk assess-

ment, likely based on the approach that is currently in These examples show that harmonization efforts ofpotential national significance can be initiated at theuse for noncarcinogens.

An approach to risk management that has gained state level. Indeed, these examples suggest that a bot-tom-up approach to harmonization of risk assessmentin importance at both the federal and state levels is

comparative risk analysis. This approach has been uti- and risk management may be a successful strategy insome cases, particularly for issues that are not cur-lized at the national level by EPA (EPA, 1990) and in

a number of states, including Michigan and California rently addressed at the federal level and which can beresolved at the regional level.(Michigan DNR, 1992; California EPA, 1994). There

are a number of problems with this approach since it Another perspective on state harmonization was pro-vided by Jeffrey Crum of the Michigan Department ofoften requires comparisons of outcomes that are mea-

sured quite differently, e.g., health vs environmental Environmental Quality, Environmental Response Divi-sion. He addressed the development of Michigan’s ap-impacts, short-term vs long-term effects, and actuarial

vs forecasted risks. These issues provide an additional proach to hazardous waste sites and the rationale fordifferences between this approach and that taken atlayer of complexity to the ones that are the focus of

this meeting, i.e., harmonization within risk types such the federal level by the U.S. EPA.The importance of environmental contamination toas among human health risks.

Michigan citizens was shown in the passage of a $700million bond issue in 1988. Prioritizing the expenditureINTRASTATE, INTERSTATE, AND FEDERAL/STATEof bond funds required the rapid development of proce-HARMONIZATIONdures to identify and prioritize the thousands of haz-ardous waste sites in Michigan. The approach to clean-To illustrate the interstate, intrastate, and federal/

state harmonization of risk assessment and risk man- up adopted was a tiered one: Type A was to clean upto background, Type B was to clean up to health-basedagement, representatives of several state agencies de-

scribed the approaches that their units have adopted. criteria based on residential exposure, and Type C wasa site-specific clean up. As a result of experience withThe first, Harold Humphrey, Michigan Department of

Community Health Division of Health Risk Assess- this system and administrative policy changes, thissystem was replaced in 1995 with one that is based onment, focused on a number of attempts by states in the

Great Lakes region, often in conjunction with Canada, land use-specific criteria, e.g., residential, commercial,industrial, and recreational.to harmonize aspects of risk assessment. This has in-

cluded extensive efforts to encourage the collection of In developing these land use-specific values, Michi-gan has generally followed U.S. EPA toxicity assess-consistent data across jurisdictions.

One example of the type of information that could be ment guidelines and values. However, there are somesignificant differences between Michigan and EPA ap-harmonized is disease incidence data, e.g., for cancer.

Representatives from a number of states met about proaches to exposure assessment. An obvious one is theincorporation of land use assumptions. In addition, in15 years ago to attempt to coordinate the information

collected in cancer registries. As a result, commonality cases where Michigan has decided to include exposurepathways for which the U.S. EPA does not provideamong state registries was significantly increased al-

though confidentiality laws in some states still limit guidance, e.g., dermal assessment of groundwater notused for drinking and inhalation of soil particles, thethe interstate use of the data.

Another example is the agreement by representa- state has had to develop its own assessment ap-proaches.tives of four Great Lakes states on a common set of

questions to include in Behavioral Risk Factor Surveys The soil exposure pathways also illustrate other dif-ferences in state and federal approaches. Michiganadministered in each state. Another recent effort, un-

der the aegis of the ATSDR, encouraged state interac- combines both the ingestion and dermal routes in itsexposure assessments; U.S. EPA guidance combinestions that led to greater commonality in questions

posed on fish consumption surveys in the Great Lakes inhalation and ingestion exposure. In addition, Michi-gan quantifies the dermal route of soil exposure whilestates.

In addition to health registries and surveys, another the U.S. EPA does not. A related issue is bioavailabilityfrom soil. Currently, bioavailability is taken into ac-area where harmonization is useful is in laboratory



count in establishing the toxicity value but biologically and management of risk from consumption of sport-delivered dose, i.e., the dose that reaches the site of caught fish in the Great Lakes region. John Hesse,toxicity, is not. Michigan Department of Community Health Division

A further difference between the federal government of Health Risk Assessment, provided an historical over-and Michigan in treatment of soil exposures reflects view of the situation.regional differences that are not taken into account at This overview described a situation where each statethe federal level. For example, the assumption of daily in the region independently developed its own advice tocontact with soil is not applicable in Michigan’s climate consumers of sport-caught fish. A problem arose whenwhere soil may be inaccessible for a significant fraction advice from different states sharing the same Greatof the year due to snow and ice cover. Lake conflicted. Recognizing this, a task force of gov-

Examination of these differences suggests that har- ernment representatives from states bordering on Lakemonization of risk assessment and risk management is Michigan was assembled and developed a common ad-not just an issue of consistency. It involves developing a visory that was subsequently adopted by all states forcommon framework and also working within this this lake.framework to take into account local or regional differ- Building on this, a larger task force representing allences so that the end product is applicable to the situa- of the Great Lakes states was convened to develop ation of interest. consensus approach within the basin. This group’s task

Charles Cubbage, of the Michigan Department of was more complex than that of the first group since itAgriculture (MDA), discussed the approach of this de- was charged with establishing a common procedurepartment to risk assessment and management. In the that could be applied into the future. This new ap-main, the department does not perform risk assess- proach entailed a change from basing the advisories onments, although it was part of a Michigan multiagency the FDA action levels to basing them strictly on risk,effort during the 1980s to produce a commonly agreed essentially an EPA approach. This group was able toupon risk assessment process. Although this process come to agreement but, as of yet, implementation ofdid result in a common report, areas of conflict still this agreement has not been consistent. For example,remain. Examples include FDA tolerances compared Michigan is currently issuing fish advisories using theto Michigan Department of Environmental Quality same approach as in the past.(MDEQ) standards and MDA versus MDEQ standards Representatives of FDA (Michael Bolger) and EPAfor cleanup of agricultural properties. (William Farland) commented on this case study. TheyThe focus of the MDA is on the management of envi- indicated that there was a recommendation over 5ronmental risk and the incorporation of many stake-

years ago for both agencies to discuss this issue andholder groups into the decision-making process. Fortry to arrive at a consistent approach, but that littleexample, a food safety council was established withprogress has been made. However, some steps haverepresentatives of over 80 stakeholder groups includ-been taken, such as the convening of representativesing environmental organizations, industry, federal andfrom almost all states in June, 1996 to discuss thisstate agencies, and commodity groups. This council hasissue. In addition, limited funds have been committedbeen instrumental in the successful resolution of envi-to gathering more information about fish consumptionronmental contamination issues such as the possibleby particular population subgroups.misuse of pesticides on food.

A further point is that discussions may be leadingAnother MDA emphasis has been on prevention ofto a broadening of the context within which fish advi-risk, especially through voluntary actions, e.g., farmersories are developed. Instead of looking only at theself-assessments of practices, integrated pest manage-risk from eating the fish, consideration of competingment, etc. With such an approach, the importance ofdietary risks and nutritional issues will be consid-risk assessment harmonization is decreased. Further-ered in meetings among the states. While the addi-more, strong stakeholder involvement in risk manage-tion of these considerations may provide a better de-ment tends to provide a legitimate arena for addressingscription of risk, this description may also be morea number of risk issues and so promotes harmoni-difficult to communicate than a simple message ofzation.what fish should or should not be eaten, how muchof those that are edible should be eaten and how of-CASE STUDY OF INTERGOVERNMENTALten, and which advice applies to specific populationHARMONIZATIONsubgroups, e.g., pregnant women.

This case study shows how inconsistencies may ariseFollowing the presentations by representatives ofand also the difficulties in readily resolving them.various state and federal agencies responsible for riskThese problems are analagous to those noted earlierassessment and management, a case study was pre-with respect to the European Union. It also illustratessented and discussed to illustrate where areas of con-

flict can occur. The case study involved the assessment the interactions among risk assessment, risk manage-



ment, and risk communication that must be considered agement approaches presented. Although the fourin any harmonization process. workshops, toxicity assessment, exposure assessment,

risk management, and risk communication, addresseddistinctly different topics, there were a number ofRISK COMMUNICATIONthemes that were common to all.

The importance of risk communication was also em- One was the concept that harmonization should bephasized by Christine Chaisson of Technical Assess- thought of in terms of common frameworks rather thanment Systems. In addition to addressing its importance sets of prescriptions. Thus, for example, all exposurein risk assessment and risk management, she pointed assessments could be conducted within a commonout that there is an important sector that is often left framework that specifies a set of scientifically acceptedout in risk communication discussions, i.e., business. procedures for assessing each exposure parameter,While there is often a clear involvement of chemical such as soil absorption. In addition, agreement mightproducers, marketers and distributors in risk deci- be reached on some quantitative values that should besions, it is less obvious that bankers, traders, retailers, used in applying these procedures to exposures fromand insurers also have a large impact on what risks particular sources, e.g., soil at hazardous waste sites.are assumed. Their decisions utilize risk assessments However, these common frameworks should not beas integral parts of internal business decisions concern- overly proscriptive and should leave room for scientificing what is produced, imported, and exported. judgement in the application of the process to specific

She also presented some basic communication princi- situations.ples that can provide an important framework for har- On the other hand, the risk management frame-monization. These include: (1) knowing the audience work could be less quantitative and describe a com-and its expectations and designing the communication mon approach and the types of issues that need to befor that audience; (2) evaluating the trust the audience addressed in this process, e.g., vulnerable subpopula-has in the messenger; (3) understanding the percep- tions. Similarly, harmonization in risk communica-tions that the audience has about the benefits as well tion could involve a set of principles that should beas the risks in the situation of interest; and (4) commu- used by communicators of risk assessment and/ornicating not only results but how they were achieved. risk management products. An example is the princi-

Harmonization issues may have a significant impact ple of incorporating public input into the risk commu-on this last principle. If different agencies or countries nication process.require different types of tests or different ways to per-One specific idea about harmonization that cutform these tests, it may be difficult to explain the rela-

across issues was the use of stepwise processes totive importance of the results achieved by the varioushelp set priorities. In exposure assessment, thisagencies or nations. Even if the procedures are themight involve comparison of exposures through dif-same, there may be problems in consistent interpreta-ferent routes and performance of detailed assess-tion of the results and thus in communicating thesements only on those routes that were found to con-findings.tribute the most to total exposure. In toxicity assess-There are many issues that can impact on interpreta-ment, this could mean devoting the most scientifiction of results. These include (1) the population toresources to investigating chemicals which showedwhich the assessment pertains, (2) the extrapolationthe smallest margin of exposure between environ-model employed, (3) absolute risk as contrasted withmental levels and the doses of concern, i.e., those ofrisk vs benefit or other trade-offs, and (4) other assump-highest risk. With respect to risk management, thistions in both the risk assessment and risk managementapproach could be used to allocate resources to man-process. On the positive side, these issues are currentlyagement approaches that would contribute to theunder active discussion and movement towards har-greatest reduction in risk. Last, with respect to riskmony appears to be occurring. It is important that thiscommunication, a stepwise approach might suggestmovement continue and that risk issues not be used asdevoting the greatest resources to issues identifiedbargaining chips in trade negotiations. If this latteras most important by all stakeholders.occurs, risk communication will be made all the more

One other common theme was to move from a me-difficult.dia-specific to a multimedia approach. For example,instead of addressing risk assessment and risk man-WORKSHOP DISCUSSIONS AND RECOMMENDATIONSagement of a chemical in surface water indepen-dently of risk analysis for the same chemical inDuring the workshops held on the second day, parti-ground water, the analysis should incorporate bothcipants discussed what they had heard on the first dayenvironmental media. Taking this approach will ofand contributed their own experiences to defining har-necessity lead to increased harmonization since com-monization and evaluating the potential for harmoni-

zation of the competing risk assessment and risk man- bining two currently disparate analyses into one will



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Government: Managing the Process. National Academy Press,Assessors and managers representing a number of in- Washington, DC.terest groups as well as a variety of individual opinions National Research Council (1993). Issues in Risk Assessment. Na-were able to work together to identify areas of agree- tional Academy Press, Washington, DC.

National Research Council (1994). Science and Judgement in Riskment. They also were able to reach some consensusAssessment. National Academy Press, Washington, DC.conclusions and shared a common view that these were

National Research Council (1996). Understanding Risk: Informingonly starting points that could profitably be followedDecisions in a Democratic Society. National Academy Press, Wash-by more intensive discussions. Continuation of the dia- ington, DC.

logue in a number of venues has the potential to lead U.S. Environmental Protection Agency. (1989a). Risk Assessmentto significant reductions in current inconsistencies in Guidance for Superfund, Vol. 1, Human Health Evaluation Man-

ual (Part A). Interim Final. EPA/540/1-89/002. Office of Emergencythe assessment, management, and communication ofand Remedial Response, Washington, DC.environmental risk. In addition to the publication of

U.S. Environmental Protection Agency. (1989b). Exposure Factorsthis article, the complete proceedings of the conferenceHandbook. EPA/600/8-89/043, Office of Health and Environmentalwill be published in book form to encourage further Assessment, Washington, DC.

discussion and consensus on this topic. U.S. Environmental Protection Agency (1990). Reducing Risk: Set-ting Priorities and Strategies for Environmental Protection. SAB-EC-90-021, Washington, DC.ACKNOWLEDGMENTS

U.S. Environmental Protection Agency. (1991). Risk AssessmentGuidance for Superfund, Vol. 1, Part B. EPA 9285.7-01B. Office ofThe author thanks the Michigan Department of Natural Re-Emergency and Remedial Response, Washington, DC.sources, Michigan Great Lakes Protection Fund for its generous sup-

U.S. Environmental Protection Agency. (1993). Integrated Risk In-port of the conference and publication of the proceedings and Mr.formation System: Announcement of Availability of BackgroundJon McDonagh-Dumler for his invaluable assistance in the perfor-Paper. Not. Fed. Regist. 58(36), 11490–11495.mance of this project.

U.S. Environmental Protection Agency. (1996a). Soil ScreeningGuidance: User’s Guide. EPA/540/R-96/018. Office of Emergency

REFERENCES and Remedial Response, Washington, DC.U.S. Environmental Protection Agency. (1996b). Proposed Guidelines

California Environmental Protection Agency (1994). Toward the 21st for Carcinogen Risk Assessment. EPA/600/P-62/003C, Washington,Century: Planning for the Protection of California’s Environment. DC.California Comparative Risk Project Final Report, Sacramento, U.S. Office of Science and Technology Policy (1985). Chemical carcin-CA. ogens: A review of the science and its associated principles. Fed.

Reg. 50, 10371–10442.Commission on Risk Assessment and Risk Management (1996). Risk


environmental risk harmonization: federal/state approaches to risk assessment and management

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