Key Points From: The Role Of Science And “Other Factors” In Codex Decisions

Key Points From:

This document presents key findings and recommendations from a longer discussion paper, prepared by Consumers International, for Item 8 on the agenda of the Thirteenth Session of the Codex Committee on General Principles, "Review of the Statements of Principle on the Role of Science and the Extent to Which Other Factors Are Taken Into Account: Application to the Case of BST and PST."

This subject is of great interest to Consumers International and its members, both from the standpoint of general principles about how risk analysis is carried out by Codex and with respect to the specific case of BST. Consumers International thus welcomed the background paper prepared by the Codex Secretariat for this agenda item, CX/GP 98/10. Unfortunately, in Consumers International’s judgment, CX/GP 98/10 is deficient in several important respects. It offers little in the way of a conceptual framework that can be used to assess why and how "other factors" should play a role in risk analysis, or how to determine which "other factors" should play which roles. It omits consideration of a number of important "other factors" that are quite obviously part of risk analysis. And it reaches conclusions and makes recommendations, both on general principles and with respect to BST, that Consumers International believes are unjustified.

Consumers International had largely drafted our own paper on this subject before CX/GP 98/10 was available. Our objective was to present a conceptual framework on the role of "other factors," and to examine both the risk analysis process in general and the BST case as an example, systematically identifying factors other than science that have played or perhaps should play roles in the risk analysis process.

This document presents the essence of our longer paper. The full paper will be available at the CCGP meeting in Paris, 7-11 September; the Table of Contents is appended here. Persons wishing to obtain a copy of the complete document in advance of the meeting may contact:

Consumers International has prepared this paper to address the role of science and the extent to which "other factors" should be taken into account in Codex decisions. Our primary emphasis is on the general principles that should apply to "other factors" within the risk analysis process; we also have appended a Case Study, applying the general approaches we discuss to the specific case of BST. We believe general policy on the use of "other factors" should be developed and then applied by Codex to the BST decision, and not the reverse.

It is evident to Consumers International that many "other factors" are now, and inevitably must be, part of risk analysis on food safety issues. Other factors arise and must be addressed in all phases of risk analysis—risk assessment, risk management and risk communication—and at all levels of the process—international (Codex) decisions, decisions by national authorities, and decisions by consumers in the marketplace. In all cases, science is a necessary basis for decisions, but never a sufficient basis in itself. Furthermore, science itself is not value-free, and even analyses and decisions made by scientific bodies typically are based on both scientific and non-scientific considerations.

Consumers International believes that a policy on "other factors" in Codex decisions is urgently needed, to promote clarity and greater transparency of decisions. In particular, it is vital to improve the ability to distinguish between scientific and non-scientific portions of the basis for decisions. We hope this process now under way at CCGP will result in a clear policy that systematically identifies "other factors" that are appropriately addressed in Codex decisions, and provides guidance as to how they should be dealt with by Codex committees.

"Other factors" that are inescapably part of Codex decisions intended to protect the health of consumers include a variety of subjective value judgments and social choices in the application of risk analysis. Among the most important are how to treat scientific uncertainty, and perceptions as to which risks are "significant." Other factors include economic concerns, such as the feasibility of risk-management options, and the benefits of the activity or substance that poses the risks. Ethical issues, such as the rights and responsibilities of all the parties involved in the risk management process, also enter the picture.

In Codex decisions with respect to food labelling, additional "other factors" may apply. In particular, consumers’ need for and expressed desire for information on a food issue must be acknowledged and given weight. Consumer preference, per se, is not a basis for Codex to prohibit or limit the use of a food substance or technology. But recognition that consumers do have preferences based on many factors that cannot be considered by Codex provides a basis for labelling, so that consumers can exercise their preferences in the marketplace and manage their own risks.

With respect to the specific case of BST, discussion is constrained somewhat by the lack of availability to date of the full scientific report from JECFA’s recent assessment of BST risks. However, based on extensive experience with risk assessment, with expert bodies and with the BST issue, Consumers International presents a general analysis, in Annex 1 of this paper, of some factors other than science that we believe are almost certainly part of the Codex risk analysis process on BST. In our view, such aspects as how to deal with the major uncertainties in the scientific data on BST risks, and judgments of whether the risks are "significant," are highly subjective, and likely to be based on "other factors," as well as on scientific evidence. We identify many "other factors" that appear likely to be part of decisions at some point in the Codex risk analysis on BST, and suggest ways to clarify what those factors are, and determine whether they have played a transparent and appropriate role in the process.

Consumers International recommends that Codex decisions on BST be held in abeyance until the following two conditions have been met:

(a) the full JECFA report on BST has been published and critically reviewed by all interested parties, and

(b) the Committee on General Principles has promulgated a policy on the role of "other factors" in Codex decisions, which can be applied to the BST case.

In Consumers International’s judgment, these two conditions are essential for any final decision on BST by Codex to be perceived as valid by consumer organizations.

Consumers International also recommends that the Codex Alimentarius Commission refer the matter of BST to the Committee on Food Labelling, as well as to the Committee on Residues of Veterinary Drugs in Foods. If BST use is permitted, labelling should be provided to allow consumers to make informed choices.

CX/GP 98/10 states… some important conclusions about JECFA’s risk assessment and its recommendations [on BST]. For example, at Paragraph 19: "…the precautionary principle…cannot apply in the case of BST as the scientific basis clearly exists." At Paragraph 24, the paper states that while "other factors" would have to be considered in conjunction with scientific evidence as a general principle, "This does not appear to be applicable to the particular case of BST where recommendations covering both risk assessment (ADI) and risk management (MRL) have been made on a scientific basis." Paragraph 19 also states "JECFA has identified no significant risk" from BST and that "no safety concern has been put forward" with respect to BST.

With all due respect, Consumers International does not accept these interpretations of JECFA’s action. Other interpretations are also possible. In our judgment, until the full JECFA report on BST has been published, it is not possible to know exactly what JECFA concluded, or what the actual basis for JECFA’s conclusions may have been. Nor can it be determined whether JECFA’s risk assessment is scientifically sound. The report must be published, reviewed by the expert community, subjected to normal scientific criticism and debate, and discussed in the context of its implications for risk management. More than one view of those implications seems likely to be tenable. The conclusion in CX/GP 98/10 that JECFA has provided "a basis in science" which then allows Codex to follow only one course of action on BST is simply not supportable.

Consumers International believes, as outlined in our discussion paper on general issues related to the role of "other factors" in risk analysis, that one cannot conclude at present that the basis for JECFA’s recommendations was "science." In all likelihood some non-scientific factors also entered into the basis for the "no ADI/no MRL" recommendation, and other factors may in fact have received great weight.

In the interests of a sound risk analysis (including effective risk communication), Codex, and in particular CCRVDF, should take no action on the JECFA recommendation until the full report has been published and reviewed. If, as Consumers International expects, a careful review of the basis for JECFA’s recommendation indicates that it was based in part on science and in part on non-scientific other factors, those other factors need to be identified and examined. Codex needs to determine whether the role of other factors as a basis for JECFA’s position is appropriate. To accomplish that, a most sensible approach appears to be first to develop general principles on the role of other factors in decisions, and then to examine the BST case for consistency with the agreed general principles.

Consumers International believes that both a critical examination of the basis for the JECFA recommendations and a sensible policy regarding the role of other factors in decisions are essential foundations for any eventual Codex decisions on BST. They are especially essential if Codex wants or expects consumer organisations and the public to accept its risk analysis of BST as valid and scientifically justified.

[NOTE: in the ANNEX to the full discussion paper, Consumers International provides an ample basis to presume that the Codex risk analysis process on BST to date has involved numerous non-scientific factors as well as scientific factors, and proposes an approach by which Codex and others can examine the risk analysis on BST, to identify "other factors" and ensure that they have been appropriately considered and weighted.]

Beyond that, however, there are a number of specific points in CX/GP 98/10 that need specific responses:

• The conclusion that JECFA’s decision to recommend "no ADI/no MRL" for BST provides a "basis in science" that precludes any Codex decision not to permit BST use, is premature, if not actually incorrect. It is not clear yet just what the basis for JECFA’s decisions was, but it seems likely that the basis included other factors, beyond science. As our analysis of the BST case shows, the situation is far more complex than CX/GP 98/10 suggests. The full JECFA report must be thoroughly reviewed, and the basis for its recommendations examined in detail, before Codex will know what approaches to the BST issue are viable risk-management options, and which of those options is most justified.
• Consumers International agrees with the statement that factors related to economic interests (of member countries participating in Codex decisions) should be based on objective data. We also agree that such data appear to be lacking in the BST case.
• Consumers International disagrees with the conclusion stated in CX/GP 98/10, that factors other than science that "run contrary to a scientific evaluation" should not be taken into account in situations where there is a "science-based" recommendation, such as JECFA’s proposed "no ADI/no MRL." We disagree for two fundamental reasons. First, the "science basis" likely already includes factors other than science, and it is essential to extract them and examine them and determine whether they have been appropriately applied. Second, this proposal ignores the second and third Statements of Principle, and sets the first Statement of Principle above all the rest. We believe it is the purpose of the four Statements of Principle to recognize that scientific and non-scientific factors have to be considered in an integrated way in Codex decisions. We support the Statements of Principle and believe the approach described therein is far sounder than making all other factors subservient to "science."
• CX/GP 98/10 quotes the EC as stating that "The assessment carried out by JECFA is not the only factor to be considered when establishing MRLs for BST," and responds to the EC position by arguing that health and safety matters must be decided on the basis of risk assessment (and, by implication, nothing else). Consumers International disagrees with this argument, for reasons just stated. The establishment of an MRL is a risk management decision and clearly involves considering factors beyond science.
• In its Recommendations, CX/GP 98/10 states as a general principle that, when health and safety matters are concerned, only the first Statement of Principle should govern. Consumers international disagrees. The Four Statements of Principle should apply in particular to Codex decisions on health and safety matters.
• In its Recommendations, CX/GP 98/10 states as a general principle that in setting MRLs for veterinary drugs, a science based risk analysis should be the basis for the Codex decision. Consumers International believes that statement is incomplete. A risk analysis based on science and other factors relevant to the protection of health and the promotion of fair trade practices should be the basis for the decision.

Consumers International believes that developing a better conceptual approach to what "other factors" are legitimate parts of the basis for decisions in food-safety risk analysis will improve the quality of decisions, improve the process for reaching decisions, and greatly facilitate risk communication about the subjects of decisions. With those goals in mind, we offer these recommendations for the Codex Alimentarius Commission and its committees and subsidiary bodies:

• Consideration of how to address "other factors" should proceed within the larger context of the ongoing discussion of risk analysis in Codex. How to deal with the "other factors" needs to be addressed in terms of all three major components of risk analysis—risk assessment, risk management, and risk communication.
• Codex should approach the role of "other factors" in risk analysis systematically, taking into account the appropriate roles of Codex itself, national authorities, and consumer buying behavior in the marketplace in weighing these factors.
• Codex should elaborate its general principles on how to consider "other factors" before it makes final decisions on BST, certain MRLs for pesticides, labelling of foods produced through biotechnology, or other issues with clearly-identified, important non-scientific components of the debate.
• The Codex Committee on General Principles should designate the precautionary principle as one of the principal "other factors" to be explicitly considered in setting Codex standards, and develop policy guidelines on when it may be appropriate to invoke this principle.
• Codex committees that establish standards to protect public health should endeavor to make all aspects of their risk assessment and risk-management processes in which non-scientific factors are considered as transparent as possible in terms of the other factors that were considered, and how they affected decisions.
• Codex committees that depend on risk assessments by JECFA, JMPR and other expert bodies should ask those advisory panels to include explicit statements of where and how the assessment is uncertain, and how much scientific certainty is required to reach defensible conclusions on key issues.
• Expert bodies should also be asked to provide explicit explanations of value judgments embedded in their risk assessments, such as the relative importance of the risks and benefits of the substance or activity being assessed, and the nature of the safety margin chosen and reasons for choosing it.
• Recognizing that individual experts make value judgments that may color their recommendations, Codex should seek to include in risk assessments on which it bases its decisions the views of a range of scientists, including academic experts and those who work for or with consumer and other public-interest NGOs, not merely industry and government scientists.
• CCGP should elaborate more fully on the meaning of the third "Statement of Principles," clarifying in detail the extent to which and the manner in which factors other than science should be weighed in Codex labelling decisions.
• Expressed consumer interest in "other factors" related to a food safety issue should be one legitimate basis for Codex labelling decisions.
• CCFL should consider labelling foods as a means that permits consumers to act in their own behalf and make their own legitimate choices, both to manage risks to their health that concern them and to serve whatever other values they wish to bring to bear on their purchase decisions.

SUMMARY
INTRODUCTION
GENERAL COMMENTS

Other Factors Related to Health Protection of Consumers
Necessary Value Judgments Embedded in Science
Value Judgments in Risk Assessments
Value Judgments in Risk Management

Scientific Uncertainty and the Precautionary Principle
Benefits
Good Practices

Other Factors Related to Promotion of Fair Practices in Food Trade,
Including Other Factors Related to Food Labelling
Purposes of Labelling
Food Labelling as a Risk-Management Tool
Food Labelling as Risk Communication

At What Points in the Risk Analysis Process Should "Other Factors"
Appropriately Be Considered?

RECOMMENDATIONS

ANNEX 1. A case Study: Application of General Principles Concerning
the Role of Science and Non-Scientific "Other Factors" to the Case
of Bovine Somatotrophin (bST)

Introduction

Other Factors in the bST Risk Analysis Process

(1) Unusual Nature of bST Risks
(2) Structure of the Risk Assessment
Scope of Risks Considered
Depth of Analysis
(3) Composition of the Expert Body
Expertise
Potential Biases
(4) Treatment of Scientific Uncertainty
(5) Determination of "Significant" Risks
(6) Benefits
(7) Animal Welfare Issues
(8) Consumer Preference

Response to Specific Points in CX/GP 98/10

Recommendations