June 8, 1998
Risk Management and the Codex Process:
Risk Management and the Codex Process:
A Consumer Perspective
I. Introduction: why we are writing this paper
The main reason we are writing this paper is to compensate for the absence of a consumer perspective in the January 1997 consultation on risk management organized by FAO/WHO. By contrast, the National Research Council (NRC), operating arm of the U.S. National Academy of Sciences, "convened a committee of 17 members from a variety of specialties … Members were selected to ensure that the perspectives of federal and state regulatory agencies, industry, and environmental and citizens groups would be included, along with those of scientists. And members were selected so as to assure a flexible view of the charge and to provide an overall balance to the committee." (p. x, Understanding Risk). Consumer organizations have articulated thoughtful positions on the subject of risk management (see attached article from Consumer Reports) and want to be included in the FAO/WHO fora where these issues are discussed.
We also believe this paper is needed to counter some of the inaccuracies, misperceptions, and apparent lack of understanding regarding consumers and risk, as expressed in a variety of Codex proceedings and documents, such as the document "Residue Management Initiatives in Codex" (CX/RVDF 96/11) prepared by Australia.
In addition to informing Codex and FAO/WHO consultation activities, this paper should also be of general use to government agencies and private organizations interested in a consumer perspective regarding risk management.
II. Risk Management is a Social Process
Risk management depends on good science but it is not a scientific activity; economic, political, ethical, and cultural factors are involved:
Risk management is "an agency decision-making process that entails consideration of political, social, economic, and engineering information with risk-related information to develop, analyze, and compare regulatory options and to select the appropriate regulatory response to a potential health hazard. The selection process necessarily requires the use of value judgments on such issues as the acceptability of risk and the reasonableness of the costs of control." (p. 19, Risk Assessment in the Federal Government: Managing the Process)
"A few less obvious points are worth emphasizing about the role of scientific analysis in risk decisions. First, such analysis often needs the substantive and methodological expertise of the economic, social, and behavioral sciences: for instance, effects on property values, tourism, scenic value, human population migrations, fairness, and public trust in government may be important outcomes of risk decisions, and they are in some cases amenable to rigorous scientific analysis. Even health risks cannot be estimated accurately without a good understanding of the behavior of the individuals and organizations that control or are affected by hazardous substances or processes." (pp. 24-25, Understanding Risk)
Risk management balances various conflicting values and interests of society; it recognizes the legitimacy of consumer concerns.
"A risk characterization must address what the interested and affected parties believe to be at risk in the particular situation, and it must incorporate their perspectives and specialized knowledge. It may need to consider alternative sets of assumptions that my lead to divergent estimates of risk; to address social, economic, ecological, and ethical outcomes as well as consequences for human health and safety; and to consider outcomes for particular populations in addition to risks to whole populations, maximally exposed individuals, or other standard affected groups." (p. 3, Understanding Risk)
Risk management requires democratic decision-making; it needs an open, transparent process.
It is participatory and deliberative:
"Success also depends on deliberations that formulate the decision problem, guide analysis to improve decision participants understanding, seek the meaning of analytic findings and uncertainties, and improve the ability of interested and affected parties to participate effectively in the risk decision process. The process must have an appropriately diverse participation or representation of the spectrum of interested and affected parties, of decision makers, and of specialists in risk analysis, at each step." (p. 3, Understanding Risk)
"… although potentially more time-consuming and cumbersome in the near term, it is often wiser to err on the side of too-broad participation rather than too- narrow participation. Organizations should seriously assess the need for involvement of the spectrum of interested and affected parties at each step, with a presumption in favor of involvement." (p. 4, Understanding Risk)
There is a problem with "leaving it to the experts":
"… Science alone can never be an adequate basis for a risk decision. This point deserves special emphasis in the light of recent proposals for risk-based decision rules that could tie public risk decisions to standardized technical procedures of risk analysis. Risk decisions are, ultimately, public policy choices." (p. 26, Understanding Risk)
There are several rationales for broad participation: (pp. 23-24, Understanding Risk)
- normative: government should obtain the consent of the governed; citizens have rights to participate meaningfully in public decision making and to be informed about the bases for government decisions.
- substantive: relevant wisdom is not limited to scientific specialists and public officials; participation by diverse groups and individuals will provide essential information and insights about a risk situation. Nonspecialists may also help design decision processes that allow for explicit examination, consideration, and weighing of social, ethical, and political values that cannot be addressed solely by analytic techniques, but also require broadly participatory deliberation.
- instrumental: broad participation may decrease conflict and increase acceptance of or trust in decisions.
III. The Interaction between Risk Assessment and Risk Management
The two are separate but not seprate.
"The conceptual distinction between risk assessment (understanding) and risk management (action) remains useful for various important purposes, such as insulating scientific activity from political pressure and maintaining the analytic distinction between the magnitude of a risk and the cost of coping with it. For the purposes of improving decision-relevant understanding of risk and making that understanding more widely accepted, however, a rigid distinction of this sort does not provide the most helpful conceptual framework. The reason, in brief, is that the analytical activities generally considered to constitute risk assessment are not sufficient by themselves to provide the needed understanding." (pp. 33-34, Understanding Risk)
Risk assessment as well as risk management involves value judgements and uncertainties (e.g., the 100-fold uncertainty factor often used for derivation of an ADI).
"Government and industry have devoted considerable resources to developing and applying techniques of risk analysis and risk characterization in order to make better informed and trustworthy decisions about hazards to human health, welfare, and the environment, yet these methods often fail to meet expectations that they can improve decision making. One reason lies in inadequacies in the techniques available for analyzing risks. A second is the fundamental and continuing uncertainty in information about risks." (p. 1. Understanding Risk)
"…scientific analysis may not always be neutral and objective as a decision-making tool, even when it meets all the tests of scientific peer review. … For example, analyses of the risks of drunk driving that highlight drivers behavior as a cause of traffic fatalities draw attention away from the equally significant factors of automobile and highway design … Science is not necessarily neutral either, in its choices of assumptions. Analysis is compromised for decision-making when it is based on assumptions about the conditions of hazard exposure that are known to be unreasonable by decision participants who were not consulted when the assumptions were selected. Even standard statistical assumptions can raise questions of bias. The assumption of the null hypothesis as used in risk analysis contains an implicit bias because it places a greater burden of proof on those who would restrict than those who would pursue a hazardous activity, presuming these activities are safe until proven otherwise." (p. 25, Understanding Risk)
There are inevitable uncertainties about the full range of effects.
"Considering a sufficiently broad range of possible harms or losses is equally important to risk characterizations. Typically, analysis focuses on only a few adverse outcomes such as cancer or birth defects in human beings that are judged to be the most serious of the possible harms. The analysis is sometimes further restricted to the effects of exposure to a particular agent (a substance or process) through a particular medium (e.g., air, water, or food intake). …
Consideration of only a few possible outcomes is usually justified on the assumption that if a decision protects adequately against the selected outcomes, it will also protect against the others … This assumption becomes increasingly suspect as the range of outcomes of concern expands from overt human health risks to effects on the immune system and related systems (e.g., allergenicity); behavior effects; psychological effects, such as anxiety and depression; ecological effects; and social, economic,and ethical impacts. (pp. 43-44, Understanding Risk)
Uncertainties and value judgments should be explicit.
"Participants in decisions need to consider both the magnitude of uncertainty and its sources and character: whether it is due to inherent randomness or to lack of knowledge; and whether it is recognized and quantifiable, recognized and indeterminate; or perhaps unrecognized." (p. 5, Understanding Risk)
Strict separation of scientific from societal considerations
is not possible.
"The aim of risk characterization, and therefore of the analytic-deliberative process on which it is based, is to describe a potentially hazardous situation in as accurate, thorough, and decision-relevant a manner as possible, addressing the significant concerns of the interested and affected parties, and to make this information understandable and accessible to public officials and to the parties." (p. 2, Understanding Risk)
Risk assessment should be done in the context of risk
management (e.g., what risk does x pose versus how can society
achieve an optimal outcome which minimizes/eliminates risk at
"Risk characterization should not be an activity added at the end of risk analysis; rather, its needs should largely determine the scope and nature of risk analysis." (p. 2, Understanding Risk)
"The analytic-deliberative process leading to a risk characterization should include early and explicit attention to problem formulation; representation of the spectrum of interested and affected parties at this early stage is imperative." (p. 6, Understanding Risk)
"Three considerations that are often missing from the formulation of risk problems have led to disputes about the subsequent risk characterizations: fairness, prevention (of pollution or risk), and rights. Acknowledging these concerns may lead to different (usually broader) problem formulations than those that emerge from the ordinary routines of government agencies." (p. 39, Understanding Risk)
It is important to assess alternatives.
Alternative assessment considers "How can we avoid exposures to hazards", rather than "which environmental problems can we ignore" (because their risks are negligible), more typical of risk analysis. (p. 41, Understanding Risk)
"… Risk assessment alone is at best a way of diagnosing symptoms of more fundamental problems with our systems of producing, transportation, and disposal. Therefore, some of the money we spend on further improving our diagnostic capabilities should rightly go to improving our capacity to cope with the problems at their sources." (Finkel, 1994)
IV. Risk Management in Codex
Who are risk managers in Codex?
A FAO/WHO Expert Consultation (1995) noted that "Risk management issues are normally discussed within Codex committees but on rare occasions JECFA has issued recommendations in this area." Of course, member countries also manage risk within their borders.
PROBLEM: Codex does not sufficiently consider factors other than science (e.g., economic, political, ethical, cultural, social concerns) in its risk management process.
PROBLEM: Codex does not consider "science" broadly enough (e.g., only a narrow range of disciplines and perspectives considered).
Involvement of consumers in Codex-related risk management processes.
The Codex Alimentarius Commission has established a medium-term objective of improved participation by consumer organizations. At its 21st session in July 1995, the Commission reiterated its strong support for greater consumer involvement in Codex matters. In particular, it agreed to advise FAO/WHO that the presence of consumers and other organizations in meetings of the Joint FAO/WHO Expert Committee on Food Additives and the Joint FAO/WHO Meetings on Pesticide Residues would improve transparency of decision-making; and noted that consumers and other organizations would be invited to nominate potential experts for scientific panels, although the final decision on selection would remain the prerogative of FAO and WHO. Codex has also made information available through the World Wide Web beginning in October 1995 with monthly updates. Furthermore, a consumer information programme, "Codex Facts and Notes" was initiated in 1995 as a pilot program and extended in 1996.
Nevertheless, there remain many practical obstacles to consumer participation in Codex. The performance of the different committees and national delegations in this regard has been highly variable. Some Codex groups have welcomed and respected consumer participation, while some others have resisted and shown discomfort with efforts by "outsiders" to play a meaningful role in their deliberations.
A paper prepared by Consumers International (CAC 21/INF-2, "Consumer Involvement in Codex", April 1995) documents that consumer participation in Codex is inadequate, both at the national and international levels. This paper, draws on the results of a survey sent to Consumers Internationals 203 member organizations to assess their involvement with Codex standards setting work in their own countries. Over half of the organizations responding to the survey said that their governments did not hold regular consultations about Codex. The survey also revealed that National Codex Committees are not representative of all interested sectors (e.g., they often omit consumers). Timely distribution of Codex documents and information, as well as financial constraints, continue to be some of the biggest obstacles that consumer organizations face, although the paper concludes that the lack of transparency and openness in the Codex system extends beyond this.
In addition, some of the Commissions actions have been distinctly counterproductive with regards to transparency and open public participation. For example, a decision to accept Maximum Residue Limits (MRLs) for growth-promoting hormones in meat productiona subject of intense interest to consumer organizations in many countrieswas taken by secret ballot at the Commissions 21st (July 1995) meeting.
Another problem concerns the Executive Committee of the Commission, which excludes consumers from its meetings. The Executive Committee consists of the Chairperson and Vice-Chairperson of the Codex Alimentarius Commission together with six other members, elected by the Commission at regular sessions from among member countries, one each coming from Africa, Asia, Europe, Latin American and the Caribbean, North America, and the South-West Pacific. Meetings of the Codex Executive Committee are closed to all others, even when the agenda has included decisions on risk management policy issues. Public policy decisions that affect the public should be made in public and allow participation by interested and affected parties. Codex executive administrative decisions can appropriately be made in private sessions.
Role of Science in Codex Decisions
At its 21st session (in July 1995) the Codex Alimentarius Commission endorsed four statements of principle on the Role of Science in the Codex Decision Making Process and the Extent to which Other Factors are Taken Into Account. These principles are:
1. The food standards, guidelines and other recommendations of Codex Alimentarius shall be based on the principle of sound scientific analysis and evidence, involving a through review of all relevant information, in order that the standards assure the quality and safety of the food supply.
2. When elaborating and deciding upon food standards, Codex Alimentarius will have regard, where appropriate, to other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade.
3. In this regard it is noted that food labelling plays an important role in furthering both of these objectives.
4. When the situation arises that members of Codex agree on the necessary level of protection of public health but hold differing views about other considerations, members may abstain from acceptance of the relevant standard without necessarily preventing the decision by Codex.
As described in the previous section, it is important to recognize that many concerns regarding food safety that are shared by both Codex experts and consumers go beyond the realm of science. Codex and the expert committees advising it frequently and appropriately go well beyond "good science" and include value judgments and social choices in decisions. For example, the incorporation of safety factors is a convention based essentially on the judgment that it is preferable to err on the side of safety. As previously stated, it is incorrect to regard Codex risk management activities as strictly scientific, and thus Codex and its expert committees should be more explicit about where they are exercising judgment, not merely drawing scientific conclusions.
As science advances, our understanding of adverse health effects changes. For example, within the past decade or two, the level of lead exposure that is considered without appreciable risk based on the best scientific evidence has been sharply reduced (see section V). Given this likelihood that the progress of science will reveal risks that were previously unrecognized from low-level exposures to residues in the diet, the precautionary principle should be applied whenever feasible to protect public health. If there is lack of knowledge or understanding of adverse effects, it is preferable to adopt stricter standards that do not put people at risk, rather than to wait for sufficient evidence. In this respect, the episode with BSE (mad cow disease) has shown that sound science alone cannot always protect public health.
V. Examples of Risk Management Approaches
The approach to risk management taken by various committees within Codex differs according to both the subject matter and their duties and terms of reference. While it is not possible to examine all the risk-management approaches used within Codex, three examples are presented here to illustrate a range of different approaches. Collectively, the examples show the need for and the value of considering factors beyond risk assessments in the risk management process.
A. Risk Management of Pesticides: Pesticide use and risk reduction versus Standard-Setting for Pesticides
Many consumer organizations have difficulty accepting the current approach used by Codex and numerous countries to assess and manage the risk from pesticides, for the following reasons:
The risk management decision-making process does not
assess alternatives to pesticide use.
Implicit in the risk assessment process is the judgment that pesticides are indispensable to agricultural production, public health and consumers quality of life.
Yet increasing numbers of farmers employ organic or biointensive integrated pest management (IPM) techniques which do not require or at least greatly reduce the use of pesticides, and increasing numbers of consumers are demanding food produced using these techniques. Also, while pesticides are credited with enhancing agricultural production and eradicating some disease-carrying organisms, there is a growing public and scientific appreciation of problems of pesticide resistance and environmental degradation associated with reliance on pesticides.
" A strategy is needed that places increased emphasis on safely managing pest problems, so that we can shift gears and reduce the emphasis on, and the costs of, managing pesticide use." (p. 90, Benbrook et al., 1996)
Codex documents assert that Good Agricultural Practice "takes into account the minimum quantities necessary to achieve adequate control, applied in such a manner that the amount of residue in the smallest practicable, and which is toxicologically acceptable," but this is widely considered to be untrue. For example, in the United States, efficacy data are not required as part of the registration of a pesticide, and there is no assurance that the minimum quantity is used. In fact, many farmers around the world use much smaller quantities of a pesticide than is dictated by GAP and still achieve adequate control; other farmers under comparable conditions achieve adequate control without any use of the pesticide.
The full impact of pesticides on human health is not known, particularly when considering:
susceptible populations (e.g., children, infants, nutritionally compromised people, elderly people, people taking immune-suppressing medicines).
"The committee believes it is essential to develop toxicity testing procedures that specifically evaluate the vulnerability of infants and children." (p. 9, Pesticides in the Diets of Infants and Children)
effects on the immune, nervous, and endocrine systems
"Of particular importance are tests for neurotoxicity and toxicity to the developing immune and reproductive systems." (p. 9, Pesticides in the Diets of Infants and Children)
multiple exposure pathways to pesticides (e.g., through diet, drinking water, exposure from indoor treatments, lawn and garden applications, golf courses).
"All exposures to pesticidesdietary and non-dietaryneed to be considered when evaluating the potential risks to infants and children. Non-dietary environmental sources of exposure include air, dirt, indoor surfaces, lawns, and pets." (p. 11, Pesticides in the Diets of Infants and Children)
concurrent exposure to other toxic substances with the same or similar mechanisms of action (e.g., other pesticides, "background" levels of dioxins, organochlorine compounds, "inert" ingredients in pesticide formulations, pharmaceuticals).
Despite these uncertainties, a recent Codex document prepared by Australia notes that
"… MRLs [i.e., pesticide standards] are normally set well below the level at which acute and/or chronic exposure to a PARTICULAR (emphasis added) residue will not present a threat to human health."
While technically correct, it omits any acknowledgement of interactions between residues, and the other valid scientific concerns and uncertainties described above.
Consumers generally do not accept absence of proof of harm as proof of safety, particularly when standards fail to consider adequately the need to protect sensitive subpopulations, do not adequately consider effects on the endocrine or immune systems or behavioral or reproductive effects, and ignore the potential for interactions among the multiple residues we all encounter in our daily lives. It is not that consumers cannot understand these complicated scientific issues, or the Codex process; consumers understand the process well, and recognize its flaws. These are deficiencies that consumers expect a body such as Codex, whose mission includes the establishment of standards intended to protect public health, to address.
Pesticide risk assessments attempt to define a "safe" or "acceptable level of exposure, using science-based conventions, such as defining a carcinogenic risk of less than 1 per million as "negligible", or applying standard uncertainty factors to a "no adverse effect level" from a study of the compound in animals. But the criteria experts use to define "safe" exposure ignore factors weighed by ordinary citizens in their definition of "acceptable", such as whether exposure is known, voluntary, or controllable by the consumer. Consumers, who can seldom tell which pesticide residues are present in foods they buy and are limited in the choices they can make to avoid these risks, often do not equate the experts definition of "safe" with "acceptable risk." Consequently, consumers regard risk assessment skeptically as a tool that hides major social value choices in a mantle of "scientific decision-making."
As one activist has put it:
"Most pesticide risk assessments are used to "scientifically" justify exposing humans and other animals to toxic pesticides against their will or without their consent." (OBrien, 1994)
Developing the data and risk assessments needed to manage pesticide risks is expensive.
"Understanding and managing pesticide risks cost more than $17 billion from 1971 through 1995, about 7.4 percent of gross pesticide sales [in the U.S.]." (p. 120, Benbrook et al., 1996)
"The best way to save on the costs of regulating pesticides is to avoid creating risks that need to be regulated." (p. 122, Benbrook et al., 1996)
In broader public policy terms, the central challenge is shifting government and international programs from an emphasis on regulating the use of and the resulting pollution from agricultural chemicals, to reducing pesticide problems by finding safer, effective pest control methods. What role, if any, Codex can play in this transition, is unclear.
B. Recombinant Bovine Growth Hormone (rbGH)
An MRL for recombinant bovine growth hormone (rbGH), also called recombinant bovine somatotropin (rbST), is being considered at step 8 by Codex. The 40th meeting (in June 1992) of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) recommended that an acceptable daily intake (ADI) and recommended MRLs for bovine somatotropins be established as "not specified", a term it uses to describe an ADI or MRL for a veterinary drug for which it considers that there is a large margin of safety for the consumption of its residues. JECFA thus considers that there is no health concern and thus no need to specify a numerical MRL.
Consumers and consumer organizations in most countries where the drug is being used or proposed for use oppose the approval and use of rbGH/rbST for several reasons, some of which are based in science but some of which clearly go beyond science:
Lack of consumer benefit. There is no evidence that the use of rbGH/rbST will benefit consumers through improved milk safety or quality. Use of the drug will not lower milk prices, at least in some countries.
Lingering Safety Concerns. Concerns include elevated levels of IGF-1 in milk of treated cows, possibility of increased levels of antibiotic residues in milk of treated cows, and possibility of increased spread of BSE and related diseases, due to a need for more protein content in the diet of treated cows.
Animal Safety/Welfare Issues. A drug that not only fails to reduce disease rates, but actually increases disease rates (including mastitis and reproductive problems) in treated animals, is unacceptable on ethical grounds to many consumers.
Other reasons. Any risk posed by rbGH is an involuntary risk to consumers unless milk and milk products are clearly labeled with respect to rbGH usea step that has been strongly resisted by most governments and the industries involved. Some consumers are also concerned about impacts on small dairy farms.
Since JECFA considered the evidence in 1992, several new scientific studies have supported the "lingering safety concerns" noted above. Nevertheless, the recommended MRL is moving toward adoption.
Many consumer concerns about the use of rbGH, including the publics aversion to accept risks that have not been conclusively proven, especially when there is no offsetting benefit to consumers, could be resolved by labeling that identified milk and dairy products from herds treated with rbGH. Labeling would enable consumers who wanted either to avoid or to purchase those products, for safety or any other reason, to make informed decisions in the marketplace.
At its 21st session (1995) the Commission approved a Project Plan for Biotechnology developed by the Executive Committee, which called for the establishment of guidelines for labelling of foods derived from biotechnology. The Codex Committee on Food Labelling (CCFL) was directed to consider the matter. The United States drafted a "discussion paper" for consideration by the CCFL on the implications of biotechnology for labelling. This paper was widely criticized by consumer groups for failing to fairly articulate consumer concerns and perspectives, and of being more of an anti-labeling position paper rather than an objective, neutral, discussion paper. (The paper only favored labeling when a clear health hazard justified a warning label). The CCFL considered the matter at its last session (the 24th, in May 1996). At that session, Consumers International urged Codex to adopt more of a pro-labeling position, a view which was supported by several member nations. CCFL decided to seek the advice of the Executive Committee, in view of the four statements of principle on the Role of Science in the Codex Decision Making Process and the Extent to which Other Factors are Taken Into Account (see previous section).
As noted in the previous section of this report, meetings of the Executive Committee are closed sessions, and despite the intense interest of consumer organizations in this labeling matter, CI (and other members of the public) were excluded from the Executive Committees discussion of biotechnology labeling. The Executive Committee stressed that the Four Statements of Principles should be closedly adhered to, and "noted that the claimed right to know was ill-defined and variable and in this respect could not be used by Codex as the primary basis of decision-making on appropriate labelling."
It is unclear what this means, and what action, if any, will be taken regarding labelling of products from cows treated with bovine somatotropins. Consumer organizations are very disappointed and frustrated with Codexs failure to come to grips with the risk-management challenge posed by rbGH.
C. Risk Management of Dietary Lead Exposure in the United States
As with pesticides today, two decades ago it was recognized that overall exposure to lead in the diet was high enough to pose significant risks, not all of which were currently adequately understood by science. Rather than take the approach (which it considered) of trying to define a "safe" level of lead contamination and set MRLs for lead in all foods, the risk management approach to lead in the diet in the United States has been to reduce human exposure to lead from food to the maximum extent feasible, from all sources that contribute to overall lead intake via the diet. This includes lead that originated as atmospheric fallout (from leaded gasoline combustion and smelter emissions), lead from lead-soldered cans, calcium dietary supplements, food additives, bottled water, wine, wine bottle seals, ceramics and other foodware. In addition, significant non-dietary sources of lead exposure have been banned or regulated (e.g., lead in paint, lead in gasoline, drinking water).
The United States recognized that defining a "safe" level of lead contamination and establishing MRLs for lead in all foods would be an enormous, difficult, lengthy, and costly administrative task, and that progress in science would continue to re-define "safe" exposure to lead at lower and lower levels. In fact, the history of scientific understanding of the health effects of lead, probably the most studied toxic substance, shows the difficulties in defining "safe" exposure, and serves as a useful model for the risk management of other agents. The overt neurotoxic effects of large doses of lead have been known for centuries. But subtler effects on the brain have only been recognized since the 1940s. Blood levels of lead considered safe just 2 decades ago have now been linked to lower IQ in children.
"The weight of evidence gathered during the 1980s clearly supports the conclusion that central and peripheral nervous systems of both children and adults are demonstrably affected by lead at exposures formerly thought to be well within the safe range." (p. 93, Measuring Lead Exposure in Infants, Children, and Other Sensitive Populations)
The U.S. Centers for Disease Control and Prevention has lowered its official "intervention" level with respect to childhood lead poisoning three times since 1970. Growing numbers of scientists now believe that the only truly "safe" level of lead in the body is probably zero.
So rather than requiring as an interim step a consensus, arbitrary, soon-outdated scientific definition of "safe" exposure, the United States chose instead to seek to reduce or eliminate all sources of dietary lead exposure to the maximum extent feasible. The result is that since the 1970s, dietary lead intake in the United States has been reduced by more than 95 percent, with relatively low administrative costs and without onerous regulatory burdens in industry.
This stands in stark contrast to the approach to risk management for pesticides in foods, wherein the emphasis is on permitting exposures that imperfect and rapidly-changing science judges "safe" rather than on taking any feasible steps to reduce overall exposure and risk.
It also contrasts with the approach taken in Codex. JECFA has established a Provisional Tolerable Weekly Intake (PTWI) for lead, and MRLs for numerous food categories have been proposed. Unfortunately, setting commodity-by-commodity standards for lead in food will consume a great deal of effort by Codex and national food safety agencies, but will do very little to reduce overall dietary lead exposure. MRLs typically are set high enough to permit lead at levels that are present because of environmental contamination, the use of lead solder in food cans, and other "unavoidable" sources. The JECFA PTWI has also been criticized for failing to address the special vulnerability of infants and children to lead. Rather than adopt MRLs that permit existing lead contamination or reduce it marginally based on debatable risk assessments, Codex should promote control of dietary lead sourcesphasing out lead in gasoline, lead soldered cans, and other sources of lead in the foods, over several years. This course of action is far more likely to produce dramatic reductions in dietary lead intake, protecting public health more effectively at less cost to governments and industries.
It is interesting to note with regard to the risk management of lead in old paint in housing, that efforts in the U.S. have involved consumer education and "right-to-know" provisions affecting buyers, sellers, and rentals of homes containing lead paint. There has been considerable public involvement in the formulation and implementation of solutions to the lead problem in the United States.
From the perspective of consumers, Codex is not doing a good job of risk management, at least on many high-profile issues that consumers care about.
For the most part, neither Codex Committees (at least horizontal committees such as CCFH, CCFAC, CCFICS, CCFL, CCPR, and CCRVDF) nor the Codex Alimentarius Commission explicitly consider political, social, economic, ecological, ethical, and engineering information together with risk-related information to develop, analyze, and compare management options, which is the process of risk management. Although some Codex participants seem to perceive that their work is merely a "scientific activity" that contributes to risk management by others, Codex standards are in fact risk management decisions. It is therefore incumbent on Codex to adhere to principles and processes that characterize good risk management in democratic societies.
The substantive and methodological expertise of the economic, social, and behavioral sciences is not sufficiently considered by Codex.
Consumer organizations have expertise and well-reasoned positions on risk management issues, and have a clear stake in the outcome of risk management decisions.
Codex could increase the acceptance of its standards by addressing what consumers believe to be at risk in the particular situation, and incorporating their perspectives and specialized knowledge.
"Acceptance of risk decisions by the broad spectrum of the interested and affected parties is usually critical to their implementation. … A risk characterization that fails to address their questions is likely to be criticized as irrelevant or incompetent, regardless of how carefully it addresses the questions it selects for attention." (p. 2, Understanding Risk)
Codex needs to improve the ability of interested and affected parties to participate effectively in the risk decision process, and to make the process more democratic. Currently, the process over-relies on experts from a narrow range of disciplines and does not have an appropriately diverse participation or representation of the spectrum of interested and affected parties at each step of the risk analysis.
Various perspectives on "good science" should be considered (e.g., include experts from a variety of constituencies, including consumers). Codex does not appear to recognize normative, substantive, and instrumental reasons for broadening participation.
Consideration of risk prevention, fairness, and rights in risk analysis would greatly increase public acceptance of Codex standards.
Codex actions to date do not reflect an adequate appreciation of the need for consumer participation and trust in its risk analysis processes.
"Solving the problems in health risk assessment goes beyond more and better science; it also requires building trust among government, industry, and citizens."
(p. 14, Researching Health Risks)
"Opposition to controversial technologies may have little to do with citizens levels of information about technology, having more to do with citizens levels of trust in governmental and industrial actors." (Freudenburg and Rursch, 1994)
Codex and its expert committees need to be more explicit about where they are exercising judgment, not merely drawing scientific conclusions.
Benbrook, Charles M., et al. Pest Management at the Crossroads. Yonkers, New York, Consumers Union, 1996.
Finkel, Adam M., "Risk Assessment Research: Only the Beginning," Risk
Analysis 14 (6): 907-911, 1994
Fischhoff, Baruch. "Risk Perception and Communication Unplugged: Twenty Years of Process," Risk Analysis 15 (2): 137-145, 1995.
Freudenburg, William R. and Julie A. Rursch, "The Risks of "Putting the Numbers in Context": A Cautionary Tale", Risk Analysis 14 (6): 949, 1994.
Moore, Monica. "The First Word", Global Pesticide Campaigner, Volume 4, Number 1, March 1994.
OBrien, Mary, "Facing Down Pesticide Risk Assessment", Global Pesticide Campaigner, Volume 4, Number 1, March 1994.
United States National Research Council. Measuring Lead Exposure in Infants, Children, and Other Sensitive Populations. Washington, DC, National Academy Press, 1993.
United States National Research Council. Pesticides in the Diets of Infants and Children. Washington, DC, National Academy Press, 1993.
United States National Research Council. Risk Assessment in the Federal Government: Managing the Process. Washington, DC, National Academy Press, 1983.
United States National Research Council. Science and Judgement in Risk Assessment. Washington, DC, National Academy Press, 1994.
United States National Research Council. Understanding Risk: Informing Decisions in a Democratic Society. Washington, DC, National Academy Press, 1996.
United States Office of Technology Assessment. Researching Health Risks. 1993.
Attachment: Developmental Stages in Risk Management
All we have to do is get the numbers right
- All we have to do is tell them the numbers
- All we have to do is explain what we mean by the numbers
- All we have to do is show them that theyve accepted similar risks in the past
- All we have to do is show them that its a good deal for them
- All we have to do is treat them nice
- All we have to do is make them partners
- All of the above
from Fischhoff, Baruch. "Risk Perception and Communication Unplugged: Twenty Years of Process," Risk Analysis 15 (2): 137-145, 1995.
NOTE: Based on the authors experience, risk management in the Codex Alimentarius Commission appears to be mostly in the first developmental stage.