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Food Safety

International Food Safety Issues EU positions papers for Codex Alimentarius CCGP - Codex Committee on General Principles

Comments from the European Commission Services to the Codex Secretariat

I. INTRODUCTION

1. The Codex Secretariat has circulated a Conference Room Document from the United States which was meant to provide comments and a list of questions on the Communication from the European Commission on the Precautionary Principle (hereinafter the Communication) (see Codex Document CX/GP 00/3-Add.6, under Agenda Item 3.1, for the 15 th Session of the Codex Committee on General Principles, Paris, 10-14 April 2000).

2. The Services of the European Commission offer the following replies to the questions raised by the U.S. Codex Conference Room Document.

II. GENERAL COMMENTS

3. The Services of the European Commission welcome the US document and the opportunity it offers to clarify further the Commission's policy on the precautionary principle. The Services of the Commission note that the US "agrees that precaution can be an integral component of regulatory decisions, and that decisions usually need to be made in the face of uncertainty". The US admits further that its "food safety laws, regulations and policies have precautionary approaches embedded in them". The US document also acknowledges that the Communication of the Commission deals with "a number of interrelated and complex issues facing the EU", and the Services of the Commission think that any responsible regulatory authority is facing the same issues.

4. The Services of the Commission consider that it is very important to clarify as far as possible the scientific and management policy considerations that are usually involved in the application of the Precautionary Principle in the European Community, in the United States and in other international fora. They welcome, therefore, the decision of the Codex Committee on General Principles to work for the elaboration of guidelines regarding the application of the Precautionary Principle. This is a serious effort in the direction of increasing transparency in the decision-making process of Codex Alimentarius and of its members. It may also prevent the application of discriminatory and arbitrary decisions in international trade. The Commission is fully committed in the observance of all these principles.

III. RESPONSES TO THE US QUESTIONS

5. The responses follow the order and headings used in the US Conference Room Document for ease of reference.

A. Points of Concern

6. The US is concerned here essentially with the lack of a precise definition in the Communication by the Commission of the proposed Precautionary Principle.

7. It should be recalled that the Precautionary Principle is not a proposition of the European Commission alone but is already inscribed into the EC Treaty and is the subject of several judgments by the European Court of Justice. For example, the Court has defined the conditions for the application of precautionary measures (i.e. the Precautionary Principle) in Community law as follows:

"Where there is uncertainty as to the existence or extent of risks to human health, the institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent" (Case C-157/96, National Farmers Union, judgment of 5.5.98, ECR 1998, page I-2211, ground 63).

8. The European Court of Justice has also explained as follows the rationale for the application of precautionary measures (i.e. the Precautionary Principle) in the area of health and environmental protection in EC law:

" That approach is borne out by Article 130r(1) of the EC Treaty, according to which Community policy on the environment is to pursue the objective inter alia of protecting human health. Article 130r(2) provides that that policy is to aim at a high level of protection and is to be based in particular on the principles that preventive action should be taken and that environmental protection requirements must be integrated into the definition and implementation of other Community policies."( Case C-157/96, supra, ground 64).

9. The US may wish to note that early this year the Member States have proposed a definition of the precautionary principle to the Codex Committee on General Principles and that the Commission supports in principle that proposal. In any case, the Commission believes that understanding the circumstances under which the precautionary principle may be used is more important than providing a static definition of the concept, which in addition is a function of the chosen level of environmental or health protection of the country taking the regulatory measure .

B. General Points

Question 1:

10. The Communication states that the proposed "precautionary principle should not be confused with the element of caution that scientists apply in their assessment of data" (Summary, section 4) and, in a separate passage, that "reliance on the precautionary principle is no excuse for derogating from the general principles of risk management." (Section 6.3, paragraph 2). The US requests the Commission to elaborate on how and where exactly its proposed precautionary principle differs from "general principles of risk management"? And to clarify what the Commission envisions as being gained, over and above appropriately conducted risk analyses, through the adoption of its proposed precautionary principle?

Answer:

11. The Commission stresses the role of science in the decision-making process and agrees that scientists ought to apply precaution in their risk assessments. Equally, risk management decisions should be based, inter alia, on available scientific information. However, scientists sometimes are not in a position to resolve all instances of uncertainty. Thus, when scientists conclude that they are unable to clearly assess the risk or when their conclusions are inconclusive or divergent, the risk manager should be able to take provisional measures without having to wait for more comprehensive scientific information becoming available or, as explained by the European Court of Justice, to wait until the reality and seriousness of the identified risks become fully apparent. This will depend also on the chosen level of health or environmental protection, as explained above. In such a case, of course, the general principles of risk management (i.e. proportionality, consistency and non-discrimination) should apply in choosing the appropriate management measure.

Question 2:

12. Throughout the Communication the Commission maintains that there is a single, yet undefined, broad "precautionary principle" that is applicable to food safety, environment, human health, animal health, and plant health. How does the Commission view its proposed precautionary principle applying to all such highly diverse areas?

Answer:

13. The underlying rationale of the precautionary principle is a policy approach of general application. It is nothing else than a risk management (policy) decision that provides that lack of full scientific evidence does not prevent the decision-maker from acting, depending on the chosen level of protection. Two conditions, therefore, are necessary for the application of the precautionary principle: first, the identification of a potentially adverse effect resulting from a phenomenon, product or process and, secondly, the impossibility of assessing the risk with sufficient certainty, for instance because of the insufficiency of the data and/or their inconclusive or imprecise nature. These two conditions can lead to a scientifically established state of uncertainty, which can exist in the field of general food safety and environmental protection as well as in human, animal or plant life or health protection. The rationale of this risk management policy approach is, therefore, applicable to any kind of risk management decision, independently of the specific area of concern.

Question 3:

14. The Commission states that the Communication will affect and reaffirm its views on "the precautionary principle" at the international level. Does the Commission believe that, given the diversity of socio-economic conditions among nations, there are aspects of precaution that, while appropriate at the national or community level, would not be appropriate at an international level? Does the Commission believe that a single principle applicable to all circumstances can usefully be developed? Please explain.

Answer:

15. The Commission believes that the diversity and complexity of socio-economic conditions could indeed influence the choice of appropriate level of health or environmental protection to be applied by a national community, but that the concepts of science, scientific uncertainty and risk are objective concepts of general and potentially universal application. To the extent risk management decisions are made or applied at international level, the precautionary principle may also be applied on the basis of agreed conditions and circumstances, for instance like those laid down in Article 5.7 of the SPS Agreement or in other relevant international agreements. This was further confirmed in the recently adopted Cartagena Protocol which refers explicitly to the same basic rationale of the Precautionary Principle, as explained above, in decision-making procedures.

Questions 4 and 6:

16. In its Communication, the Commission states that the decision to act or not, i.e. to exercise precaution or not, is a "political decision." Does this characterisation mean that the decision need not also be science based? How can the Commission ensure that its proposed precautionary principle is not used to justify the adoption of arbitrary decisions when a clear definition has not been provided and when political decisions will determine its use?

Answer:

17. The term "political decision" used in the Communication means "risk management decision" taken by the responsible regulatory authorities. This decision must be science-based, but it is not up to the individual scientists to decide on the acceptable level of risk imposed on the society as a whole. That decision is essentially a political or a societal value judgement to be taken by the responsible regulatory authorities, such as the FDA or USDA in the US, or the Council, the Council and Parliament and, sometimes, the European Commission in the EU. The Commission's Communication and the guidelines proposed therein are intended precisely to avoid unwarranted and arbitrary risk management decisions, by clarifying when the precautionary principle comes into play and by placing conditions on how risk managers should act. As explained, in order to achieve the objectives of transparency and avoid arbitrariness in decision-making, laying down guidelines is more important than providing a static, formalistic definition of the precautionary principle.

Question 5:

18. Since complete scientific certainty is the exception, rather than the norm, how does the Commission's proposed precautionary principle differ from most decisions that must be taken when implementing regulatory measures?

Answer:

19. It is true that risk assessment sometimes requires dealing with scientific uncertainty. Indeed, risk assessors are used to or are often required to take into account uncertainty factors. But risk managers should be made fully aware of these uncertainty factors when they adopt measures based on the scientific opinions provided by risk assessors. Taking into account of such uncertainty factors, however, cannot eliminate in all cases scientific uncertainty and the potential for adverse effects. It is therefore reasonable that when the available scientific evidence is insufficient, inconclusive or where scientists are divided in their opinions, for decision-makers not to wait until the full scientific knowledge becomes available or the uncertainty completely resolved. In such situations, applying the Precautionary Principle is a risk-management decision to act without having to wait for more or complete scientific evidence or without having to wait until the reality and seriousness of the identified risks become fully apparent, in order to achieve the chosen level of health or environmental protection.

C. The Role of Transparency

Questions 7 and 8:

20. Considering that improvements in communication technology have increased the amount of misinformation available to the public and that misinformation regarding perceived risks can be harmful, in the context of the Communication, what does the Commission envision as the role of governments in communicating to the public the distinctions between levels of risks as perceived by the public versus risks as evaluated by scientists? The Commission Communication stresses the need for a structured decision making process that is "transparent" and which "involve [s] as early as possible" the views of "all interested parties" (summary paragraph 1). Does the Commission have practical guidelines to ensure that transparency is achieved in the consideration and exercise of precaution? Would this include opening scientific advisory committee meetings to the public?

Answer:

21. These questions are a corner stone of the issues discussed in the Communication. The US appear to consider that improvement in communication technology have increased the amount of misinformation available to the public, leading to a wrong perception of risk. The Commission Services believe that the new communication technology can be also a tool to improve transparency by providing scientifically correct and reliable information to the public expeditiously. This is likely to increase objectivity in decision-making in this important area of regulation. The Commission expects the new European Food Authority to be given the responsibility of communicating with the public on risk assessment outcomes. More generally, the Commission Services consider that the role of governments or of public authorities is to try to understand the rationale behind the public's concerns and to give as clear explanations as possible about the reasoning and the need of the risk management decisions taken. The Commission has not yet developed practical guidelines to ensure the achievement of this wider and more active participation by the public. This will notably be part of the on going process to develop risk analysis procedures, as indicated in its White Paper on Food Safety.

D. Clarification of Terminology

Question 9:

22. What is the gauge for measuring "acceptability to the public" and, therefore, how would the concept be applied? How does this term relate to a political decision to act under the Commission's precautionary principle?

Answer:

23. The decision about what risk is acceptable to the public depends directly on (or rather results from) the level of risk to health or the environment deemed appropriate by a member in its territory. Therefore, the decision where to set the acceptable level of risk is a societal value judgement. Defining this level of acceptable risk may be done independently from the decision to act or not to act in a specific case and context. Applying the precautionary principle in the appropriate cases, therefore, aims at achieving the chosen level of health or environmental protection, provided that the other conditions identified in the Communication are fulfilled.

Question 10:

24. Would the Commission please explain what it means by "incomplete risk assessments?"

Answer:

25. A complete risk assessment procedure is described in annex III of the Communication and includes four components: hazard identification, hazard characterisation, appraisal of exposure and risk characterisation. An incomplete risk assessment is a preliminary assessment of a hazard, where the experts are not able to fully perform all of the above four steps because the available data are incomplete, inaccurate or inconclusive. Sometimes, in an incomplete risk assessment only the hazard identification is scientifically possible .

Question 11:

26. In the context of the Communication, does the Commission consider the terms "inconclusive" and "uncertain" (Introduction, paragraph 8; Section 3, box) to be the same? Please explain.

Answer:

27. The terms "inconclusive and uncertain information" have a slightly different meaning: the term "inconclusive" means information that cannot lead to conclusive or definitive results in risk assessment, while the term "uncertain" means indefinite or indeterminate information; not certain to occur; problematical; not reliable; dubious, etc. Both terms are meant to describe conditions of true scientific uncertainty, in which case the precautionary principle may be applied.

Question 12:

28. Does the term "precaution-based approach" mean the same as the proposed "precautionary principle?" If not, what is the difference? Is the term "precaution-based approach" sufficiently interchangeable that the Commission sees it as being just as acceptable at the international level as its proposed precautionary principle?

Answer:

29. The phrase "precaution-based approach", which appeared once in the introduction of the Communication, is not an accurate translation of the original French text. The French term is "une approche basée sur le principe de precaution", which can more accurately be translated into English as "an approach based on the precautionary principle" (see, e.g., the fourth paragraph, second sentence of the Summary). In any case, the Commission considers that the principle that responsible governments should act on the basis of precaution when there is established scientific uncertainty in order to achieve the chosen level of protection is so widely and universally accepted that it has now become a rule of customary international law in the areas of health and environmental protection.

Question 13:

30. Would the Commission please elaborate on why it makes a distinction between "prudential" and "precautionary," what the significance of the distinction is, and how it is to be applied?

Answer:

31. A prudential approach is one that takes into account a pre-defined safety factor or safety margin when a risk to health or the environment is to be evaluated. Examples of such a safety margin are given in the paragraph 5.1.3 of the Communication. In some situations, however, lack, incomplete or conflicting scientific data may prevent risk evaluators from using such a prudential approach in their risk assessment. Prudence and precaution, therefore, are two qualitatively different notions: prudence is expected from any scientist performing a risk assessment; precaution is normally applied by risk managers in case of established scientific uncertainty that risk assessors cannot reduce, eliminate or quantify.

E. The Role of the Commission's Proposed "Precautionary Principle" in International Law

Question 14:

32. How can the Commission claim that its proposed "precautionary principle" is "enshrined" in various international conventions (e.g., 1992 Rio Conference, the WTO SPS Agreement, and the Convention on Biological Diversity) when the Commission's term and concept, as outlined in the Communication, never appears in the legal text of these conventions?

Answer:

33. This question appears to be purely about semantics. As explained above, what is important to note is that the principle according to which responsible governments should act on the basis of precaution when there is established scientific uncertainty in order to achieve the chosen level of protection is so widely and universally accepted that it has already become a rule of customary international law in the areas of health and environmental protection. Consequently, some divergence in the terminology used in the various international conventions or agreements is of no significance. For example, the Ministerial Declaration (1987) on the Protection of the North Sea calls for a "precautionary approach", while the New Ministerial Declaration (1990) on the Protection of the North Sea calls for "the application of the precautionary principle" (i.e. not a precautionary principle). On the other hand, Principle 15 of the Rio Declaration uses the term "precautionary approach", but the Convention on Climate Change uses the term "precautionary measures". Lastly, the Cartagena Protocol on Biosafety refers to the "precautionary approach" in its preamble, but uses terminology which clearly reflects the same basic rationale and conditions for application of the precautionary principle in Articles 10 and 11 relating to decision-making. Equally, the WTO/SPS Agreement does not explicitly use the term precautionary principle in Article 5.7, however the AB in the Hormones case stated that the precautionary principle found reflection in that Article and that "there is no need to assume that Article 5.7 exhausts the relevance of the precautionary principle". It follows that, in accordance with the generally accepted theory of international law, the precautionary principle has already (or is in the process of) been crystallised as a customary rule of international law, because all the requisite elements of usus and opinio necessitatis in this case exist and have met with very strong, consistent and widespread acceptance. In any case, international law does not necessarily require that there should be a consistent and unanimous repetition over time of the acts or a conduct for a new customary rule to take shape and become acceptable.

Question 15:

34. Please explain more concretely how the Commission plans to use its proposed precautionary principle "at the international level."

Answer:

35. The Services of the Commission consider that there may be a real need for clarification about the use of the Precautionary Principle in the WTO. This could also make it easier to dispel fears that the Precautionary Principle might be used in an arbitrary or unjustified way and, therefore, to confirm that measures based on the Precautionary Principle should comply with basic trade law principles, such as non-discrimination, least-trade restrictiveness and transparency. Clearly, this would be in the interest of all concerned, not least the EU, to reaffirm that the Precautionary Principle should not be used for protectionist purposes. Consideration might also be given on whether it would be useful to develop more precise guidelines for the actual application of the precautionary principle. As explained this is likely to increase transparency and consistency in international trade. For instance, the Codex Alimentarius could develop such guidelines. The EU is one of the largest exporter in the world and has suffered from trade barriers imposed by importer countries without clear justification.

F. The Role of the Commission's Proposed "Precautionary Principle" in the EU

Questions 16 and 17:

36. What is the status of the Commission's Communication with the EU Member States? Have Member States supported the Communication? What is the future status of the current version of the Communication? Do you envisage drafting a revised text based on comments received? Please explain more concretely how the Commission plans to use its proposed precautionary principle "at the EU level." Is it the Commission's intention to have a consistent application of this principle by all Member States? If so, how would this be achieved, e.g., by EU regulation or directive? Would the European Parliament have a role? How will the responsibilities for risk assessment and risk management be assigned at the EU level and at the Member State level?

Answer:

37. The Communication of the Commission is first and foremost a political commitment of the Commission itself to act in a specific manner under certain circumstances. Communications are not legally binding under EC law for the other EU institutions or the Member States. However, the Communication on the precautionary principle is likely to encourage convergence of approaches at EU and national levels between all the responsible risk management authorities, as well as at international level. The Member States, the Council, the European Parliament and the Economic and Social Committee are currently studying the Communication. So far, it has been welcomed by the Member States. The Council Presidency forwarded a report on it to the European Council summit meeting in June 2000. The position paper sent by the Member States early this year in reply of the Codex's Circular Letter on this issue is in line with the approach outlined in the Communication.

The Commission can of course revise the Communication, if it feels necessary or in the light of comments. It is not, however, the Commission's intention for the time being to propose a directive or a regulation in order to impose a particular manner in the application of the precautionary principle in the EU.

The responsibilities for carrying out the risk assessment and the risk management functions in the EU are described in the Communication of the Commission on Food Safety and Consumer Protection of 30 April 1997, as well as in the recent White Paper on Food Safety. Broadly speaking, this depends on the repartition of competence under EC law and it may be carried out at times at EU level and at times at national (Member State) level.

G. Application and Implementation

Question 18:

38. How would the Commission's proposed precautionary principle be applied politically? When a nation establishes its appropriate level of protection and/or at other times? Please explain.

Answer:

39. As explained, applying the precautionary principle is a risk management policy decision in situations where the scientific evidence is incomplete, inconclusive or divergent and action is considered necessary in order to achieve the chosen level of health or environmental protection. This action is, therefore, normally independent and may actually precede the decision setting or selecting the desired level of health or environmental protection. For instance, as the Appellate Body has accepted in the Australian Salmon and the Japanese Varietal Testing cases, the two decisions may also coincide chronologically.

Questions 19 and 20:

40. Does the Commission agree that evaluating the "efficacy of possible options" (Introduction, Section 6, paragraph 5; Section 6.3.4, paragraph 4) is part of determining the benefits of a risk management option? If so, why is this interpreted to be a part of a "broader" consideration and how would it be applied? How would the results of a cost/benefit analysis be used together with an application of the Commission's proposed precautionary principle in decision making?

Answer:

41. Evaluating the efficacy of a possible option is a comparison of the effectiveness of the different measures which are technically available in order to achieve the chosen level of health or environmental protection. The choice of course should be oriented to the least trade-restrictive measure taking into account technical and economic feasibility. The decision-making process in this case is a process of weighing risk management policy alternatives. So, a cost/benefit analysis could be part of this process of weighing, selecting and implementing the appropriate option, having always in mind the paramount need to achieve the chosen level of protection deemed appropriate by a member in its territory.

Questions 21and 24:

42. What scientific criteria would the Commission consider under its proposed precautionary principle in identifying a food safety hazard? Can the Commission's proposed precautionary principle be triggered without the identification of a hazard?

Answer:

43. The Commission considers that a food safety hazard is scientifically identified by a description of the hazard itself and its potential adverse effects on the population (cf. Hazard identification definition in Codex). Hazard identification is the first step of a risk assessment. Of course, if no hazard is scientifically identified, there is in principle no reason to take any measure based precisely on the precautionary principle.

Question 22:

44. Do the Commission's guidelines for use of its proposed precautionary principle place consumer and political concerns on the same level as scientific information when implementing a measure?

Answer:

45. Scientific information is a prerequisite for the application of the precautionary principle. Thus, all efforts should be made to evaluate the available scientific information. However, when this evaluation shows that a non-action may have undesirable health or environmental consequences, the question of adopting the appropriate protective measures arises. In this context, consumer and political concerns may play a role in the triggering factor, i.e. the decision to act without having to wait for more scientific evidence. Normally, consumer concerns are caused or driven by identification of a potentially negative effect on health or the environment. Consequently, the decision to conduct an evaluation of the available scientific and other data is bound up with a less theoretical and a more concrete perception of the risk. In any case, the measure implemented must be based on the available scientific information and be deemed necessary to achieve the chosen level of health or environmental protection.

H. Triggering Uses of the Commission's Proposed "Precautionary Principle"

Question 23:

46. How does the Commission draw the distinctions between its proposed precautionary principle and the WTO SPS Agreement's concept of "appropriate level of protection?"

Answer:

47. To apply the precautionary principle is a risk management policy decision in case of established scientific uncertainty. It justifies the adoption of provisional protective measures without having to waiting for more evidence, when science is not able or is not likely to give quick and sufficiently clear answers about an properly identified hazard. The SPS Agreement defines the "appropriate level of protection" as the level of risk acceptable by a WTO member. Risk management measures are supposed to be designed to achieve that chosen level of health or environmental protection. In the view of the Services of the Commission when there is scientific uncertainty as to the risks to health or the environment, authorities may take protective measures without having to wait until the reality and seriousness of the identified risks become fully apparent. It appears, therefore, that there is no difference of approach between the Communication of the Commission and the relevant provisions of the SPS Agreement.

Question 25:

48. The Commission implies that there are considerations other than protecting the public health that may justify choosing a particular SPS measure. We would appreciate an explanation by the Commission about what those considerations might be and how those considerations would come into play in selecting a particular SPS measure?

Answer:

49. This question seems to have nothing to do with the concept of the precautionary principle discussed here. It is replied, however, for the sake of completeness. As it is known, Article 5.2 of the SPS Agreement provides a list of factors that should be taken into account in the performance of a risk assessment. For instance, the Appellate Body report in the Hormones case stated that "there is nothing to indicate that the listing of factors that may be taken into account in a risk assessment of Article 5.2 was intended to be a closed list. It is essential to bear in mind that the risk that is to be evaluated in a risk assessment under Article 5.1 is not only risk ascertainable in a science laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words, the actual potential for adverse effects on human health in the real world where people live and work and die." Also when elaborating food standards in the context of the Codex Alimentarius "other legitimate factors" relevant for the health protection of consumers and for the promotion of fair practices in food trade may be taken into account. The Services of the Commission consider that other legitimate factors can be taken into account in the risk management phase, which may justify a particular SPS measure. For instance, the Community has prohibited the use of BST (a bovine somatotropine) within the Community on established grounds of animal health. See also the answers to questions 9 and 18 above.

Question 26:

50. How does the Commission intend to use "all pertinent factors (e.g., socio-economic)" to improve a risk assessment, which is science based?

Answer:

51. There is no such reference in the Communication. The Communication does not claim that socio-economic factors are or can be used in order to improve the risk assessment. The Commission Services believe that such factors can be taken into account, where relevant and appropriate, in the risk management phase. See also the answer to question 3 above.

Question 27:

52. How would the Commission establish preventive measures to mitigate "potential risks" without a scientific basis? What boundaries, if any, would the Commission seek to establish to prevent abuse?

Answer:

53. A risk assessment based on, inter alia, the available scientific information is needed to establish a risk management measure. But scientific uncertainty resulting, for example, from the insufficiency of the available scientific evidence is not a reason to postpone taking a precautionary measure in case of an identified hazard. To prevent potential abuse, the Communication states clearly that an approach based on the precautionary principle should start with a scientific risk assessment. See also answer to questions 21 and 24.

IV. CONCLUSIONS

The European Commission is committed to transparency in this important area of food safety and environmental protection. Its Communication on the Precautionary Principle and the above replies by the Services of the Commission to the questions raised by the U.S. Delegation are expected to clarify further this important area of law and policy and help avoid misunderstandings about the true motivations and the actual conditions for the application of the Precautionary Principle by the European Commission.

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International Food Safety Issues EU positions papers for Codex Alimentarius
FOOD SAFETY | PUBLIC HEALTH | CONSUMER PROTECTION | DIRECTORATE GENERAL "HEALTH & CONSUMER PROTECTION"

 
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