Working Principles for Risk Analysis
Risk Analysis Principles Applied by the Codex Committee on Food Additives and Contaminants
CCFAC Policy for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups
CONTENTS OF THIS SECTION
This Section contains risk analysis policy documents adopted by the Commission, which apply to and guide the work of the Commission and its subsidiary bodies. The Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius were adopted by the Commission in 2003.
The Risk Analysis Principles Applied by the Codex Committee on Food Additives and Contaminants and the CCFAC Policy for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups were adopted by the Commission in 2005.
1. These principles for risk analysis are intended for application in the framework of the Codex Alimentarius.
2. The objective of these Working Principles is to provide guidance to the Codex Alimentarius Commission and the joint FAO/WHO expert bodies and consultations, so that food safety and health aspects of Codex standards and related texts are based on risk analysis.
3. Within the framework of the Codex Alimentarius Commission and its procedures, the responsibility for providing advice on risk management lies with the Commission and its subsidiary bodies (risk managers), while the responsibility for risk assessment lies primarily with the joint FAO/WHO expert bodies and consultations (risk assessors).
RISK ANALYSIS - GENERAL ASPECTS
4. The risk analysis used in Codex should be:
open, transparent and documented;
conducted in accordance with both the Statements of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to Which Other Factors are Taken into Account and the Statements of Principle Relating to the Role of Food Safety Risk Assessment; and
evaluated and reviewed as appropriate in the light of newly generated scientific data.
5. The risk analysis should follow a structured approach comprising the three distinct but closely linked components of risk analysis (risk assessment, risk management and risk communication) as defined by the Codex Alimentarius Commission, each component being integral to the overall risk analysis.
6. The three components of risk analysis should be documented fully and systematically in a transparent manner. While respecting legitimate concerns to preserve confidentiality, documentation should be accessible to all interested parties.
7. Effective communication and consultation with all interested parties should be ensured throughout the risk analysis.
8. The three components of risk analysis should be applied within an overarching framework for management of food related risks to human health.
9. There should be a functional separation of risk assessment and risk management, in order to ensure the scientific integrity of the risk assessment, to avoid confusion over the functions to be performed by risk assessors and risk managers and to reduce any conflict of interest. However, it is recognized that risk analysis is an iterative process, and interaction between risk managers and risk assessors is essential for practical application.
10. When there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, the Codex Alimentarius Commission should not proceed to elaborate a standard but should consider elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence.
11. Precaution is an inherent element of risk analysis. Many sources of uncertainty exist in the process of risk assessment and risk management of food related hazards to human health. The degree of uncertainty and variability in the available scientific information should be explicitly considered in the risk analysis. Where there is sufficient scientific evidence to allow Codex to proceed to elaborate a standard or related text, the assumptions used for the risk assessment and the risk management options selected should reflect the degree of uncertainty and the characteristics of the hazard.
12. The needs and situations of developing countries should be specifically identified and taken into account by the responsible bodies in the different stages of the risk analysis.
RISK ASSESSMENT POLICY
13. Determination of risk assessment policy should be included as a specific component of risk management.
14. Risk assessment policy should be established by risk managers in advance of risk assessment, in consultation with risk assessors and all other interested parties. This procedure aims at ensuring that the risk assessment is systematic, complete, unbiased and transparent.
15. The mandate given by risk managers to risk assessors should be as clear as possible.
16. Where necessary, risk managers should ask risk assessors to evaluate the potential changes in risk resulting from different risk management options.
17. The scope and purpose of the particular risk assessment being carried out should be clearly stated and in accordance with risk assessment policy. The output form and possible alternative outputs of the risk assessment should be defined
18. Experts responsible for risk assessment should be selected in a transparent manner on the basis of their expertise, experience, and their independence with regard to the interests involved. The procedures used to select these experts should be documented including a public declaration of any potential conflict of interest. This declaration should also identify and detail their individual expertise, experience and independence. Expert bodies and consultations should ensure effective participation of experts from different parts of the world, including experts from developing countries.
19. Risk assessment should be conducted in accordance with the Statements of Principle Relating to the Role of Food Safety Risk Assessment and should incorporate the four steps of the risk assessment, i.e. hazard identification, hazard characterization, exposure assessment and risk characterization.
20. Risk assessment should be based on all available scientific data. It should use available quantitative information to the greatest extent possible. Risk assessment may also take into account qualitative information.
21. Risk assessment should take into account relevant production, storage and handling practices used throughout the food chain including traditional practices, methods of analysis, sampling and inspection and the prevalence of specific adverse health effects.
22. Risk assessment should seek and incorporate relevant data from different parts of the world, including that from developing countries. These data should particularly include epidemiological surveillance data, analytical and exposure data. Where relevant data are not available from developing countries, the Commission should request that FAO/WHO initiate time-bound studies for this purpose. The conduct of the risk assessment should not be inappropriately delayed pending receipt of these data; however, the risk assessment should be reconsidered when such data are available.
23. Constraints, uncertainties and assumptions having an impact on the risk assessment should be explicitly considered at each step in the risk assessment and documented in a transparent manner. Expression of uncertainty or variability in risk estimates may be qualitative or quantitative, but should be quantified to the extent that is scientifically achievable.
24. Risk assessments should be based on realistic exposure scenarios, with consideration of different situations being defined by risk assessment policy. They should include consideration of susceptible and high-risk population groups. Acute, chronic (including long-term), cumulative and/or combined adverse health effects should be taken into account in carrying out risk assessment, where relevant.
25. The report of the risk assessment should indicate any constraints, uncertainties, assumptions and their impact on the risk assessment. Minority opinions should also be recorded. The responsibility for resolving the impact of uncertainty on the risk management decision lies with the risk manager, not the risk assessors.
26. The conclusion of the risk assessment including a risk estimate, if available, should be presented in a readily understandable and useful form to risk managers and made available to other risk assessors and interested parties so that they can review the assessment.
27. While recognizing the dual purposes of the Codex Alimentarius are protecting the health of consumers and ensuring fair practices in the food trade, Codex decisions and recommendations on risk management should have as their primary objective the protection of the health of consumers. Unjustified differences in the level of consumer health protection to address similar risks in different situations should be avoided.
28. Risk management should follow a structured approach including preliminary risk management activities, evaluation of risk management options, monitoring and review of the decision taken. The decisions should be based on risk assessment, and taking into account, where appropriate, other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade, in accordance with the Criteria for the Consideration of the Other Factors Referred to in the Second Statement of Principles.
29. The Codex Alimentarius Commission and its subsidiary bodies, acting as risk managers in the context of these Working Principles, should ensure that the conclusion of the risk assessment is presented before making final proposals or decisions on the available risk management options, in particular in the setting of standards or maximum levels, bearing in mind the guidance given in paragraph 10.
30. In achieving agreed outcomes, risk management should take into account relevant production, storage and handling practices used throughout the food chain including traditional practices, methods of analysis, sampling and inspection, feasibility of enforcement and compliance, and the prevalence of specific adverse health effects.
31. The risk management process should be transparent, consistent and fully documented. Codex decisions and recommendations on risk management should be documented, and where appropriate clearly identified in individual Codex standards and related texts so as to facilitate a wider understanding of the risk management process by all interested parties.
32. The outcome of the preliminary risk management activities and the risk assessment should be combined with the evaluation of available risk management options in order to reach a decision on management of the risk.
33. Risk management options should be assessed in terms of the scope and purpose of risk analysis and the level of consumer health protection they achieve. The option of not taking any action should also be considered.
34. In order to avoid unjustified trade barriers, risk management should ensure transparency and consistency in the decision-making process in all cases. Examination of the full range of risk management options should, as far as possible, take into account an assessment of their potential advantages and disadvantages. When making a choice among different risk management options, which are equally effective in protecting the health of the consumer, the Commission and its subsidiary bodies should seek and take into consideration the potential impact of such measures on trade among its Member countries and select measures that are no more trade-restrictive than necessary.
35. Risk management should take into account the economic consequences and the feasibility of risk management options. Risk management should also recognize the need for alternative options in the establishment of standards, guidelines and other recommendations, consistent with the protection of consumers' health. In taking these elements into consideration, the Commission and its subsidiary bodies should give particular attention to the circumstances of developing countries.
36. Risk management should be a continuing process that takes into account all newly generated data in the evaluation and review of risk management decisions. Food standards and related texts should be reviewed regularly and updated as necessary to reflect new scientific knowledge and other information relevant to risk analysis.
37. Risk communication should:
i) promote awareness and understanding of the specific issues under consideration during the risk analysis;
ii) promote consistency and transparency in formulating risk management options/recommendations;
iii) provide a sound basis for understanding the risk management decisions proposed;
iv) improve the overall effectiveness and efficiency of the risk analysis;
v) strengthen the working relationships among participants;
vi) foster public understanding of the process, so as to enhance trust and confidence in the safety of the food supply;
vii) promote the appropriate involvement of all interested parties; and
viii) exchange information in relation to the concerns of interested parties about the risks associated with food.
38. Risk analysis should include clear, interactive and documented communication, amongst risk assessors (Joint FAO/WHO expert bodies and consultations) and risk managers (Codex Alimentarius Commission and its subsidiary bodies), and reciprocal communication with member countries and all interested parties in all aspects of the process.
39. Risk communication should be more than the dissemination of information. Its major function should be to ensure that all information and opinion required for effective risk management is incorporated into the decision making process.
40. Risk communication involving interested parties should include a transparent explanation of the risk assessment policy and of the assessment of risk, including the uncertainty. The need for specific standards or related texts and the procedures followed to determine them, including how the uncertainty was dealt with, should also be clearly explained. It should indicate any constraints, uncertainties, assumptions and their impact on the risk analysis, and minority opinions that had been expressed in the course of the risk assessment (see para. 25).
41. The guidance on risk communication in this document is addressed to all those involved in carrying out risk analysis within the framework of Codex Alimentarius. However, it is also of importance for this work to be made as transparent and accessible as possible to those not directly engaged in the process and other interested parties while respecting legitimate concerns to preserve confidentiality (See para. 6).
SECTION 1. SCOPE
1) This document addresses the respective applications of risk analysis principles by the Codex Committee on Food Additives and Contaminants (CCFAC) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). For matters which cannot be addressed by JECFA, this document does not preclude the possible consideration of recommendations arising from other internationally recognized expert bodies, as approved by the Commission.
2) This document should be read in conjunction with the Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius.
SECTION 2. CCFAC and JECFA
3) CCFAC and JECFA recognize that communication between risk assessors and risk managers is critical to the success of their risk analysis activities.
4) CCFAC and JECFA should continue to develop procedures to enhance communication between the two committees.
5) CCFAC and JECFA should ensure that their contributions to the risk analysis process involve all interested parties and are fully transparent and thoroughly documented. While respecting legitimate concerns to preserve confidentiality, documentation should be made available, upon request, in a timely manner to all interested parties.
6) JECFA, in consultation with CCFAC, should continue to explore developing minimum quality criteria for data requirements necessary for JECFA to perform risk assessments. These criteria are used by CCFAC in preparing its Priority List for JECFA. The JECFA Secretariat should consider whether these minimum quality criteria for data have been met when preparing the provisional agenda for meetings of JECFA.
SECTION 3. CCFAC
7) CCFAC is primarily responsible for recommending risk management proposals for adoption by the CAC.
8) CCFAC shall base its risk management recommendations to the CAC on JECFA's risk assessments, including safety assessments, of food additives, naturally occurring toxicants, and contaminants in food.
9) In cases where JECFA has performed a safety assessment and CCFAC or the CAC determines that additional scientific guidance is necessary, CCFAC or CAC may make a more specific request to JECFA to obtain the scientific guidance necessary for a risk management decision.
10) CCFAC's risk management recommendations to the CAC with respect to food additives shall be guided by the principles described in the Preamble and relevant annexes of the Codex General Standard for Food Additives.
11) CCFAC's risk management recommendations to the CAC with respect to contaminants and naturally occurring toxicants shall be guided by the principles described in the Preamble and relevant annexes of the Codex General Standard for Contaminants and Naturally Occurring Toxins in Food.
12) CCFAC's risk management recommendations to the CAC that involve health and safety aspects of food standards shall be based on JECFA's risk assessments and other legitimate factors relevant to the health protection of consumers and to ensuring fair practices in food trade in accordance with the Criteria for the Consideration of the Other Factors Referred to in the Second Statement of Principles.
13) CCFAC's risk management recommendations to the CAC shall take into account the relevant uncertainties and safety factors described by JECFA.
14) CCFAC shall endorse maximum use levels only for those additives for which 1) JECFA has established specifications of identity and purity and 2) JECFA has completed a safety assessment or has performed a quantitative risk assessment.
15) CCFAC shall endorse maximum levels only for those contaminants for which 1) JECFA has completed a safety assessment or has performed a quantitative risk assessment and 2) the level of the contaminant in food can be determined through appropriate sampling plans and analysis methods, as adopted by Codex. CCFAC should take into consideration the analytical capabilities of developing countries unless public health considerations require otherwise.
16) CCFAC shall take into account differences in regional and national food consumption patterns and dietary exposure as assessed by JECFA when recommending maximum use levels for additives or maximum levels for contaminants and naturally occurring toxicants in food.
17) Before finalising proposals for maximum levels for contaminants and naturally occurring toxicants, CCFAC shall seek the scientific advice of JECFA about the validity of the analysis and sampling aspects, about the distribution of concentrations of contaminants and naturally occurring toxicants in foods and about other relevant technical and scientific aspects, including dietary exposure, as necessary to provide for a suitable scientific basis for its advice to CCFAC.
18) When establishing its standards, codes of practice, and guidelines, CCFAC shall clearly state when it applies any other legitimate factors relevant to the health protection of consumers and to ensuring fair practices in food trade in accordance with the Criteria for the Consideration of the Other Factors Referred to in the Second Statement of Principles, in addition to JECFA's risk assessment, and specify its reasons for doing so.
19) CCFAC's risk communication with JECFA includes prioritising substances for JECFA review with the view towards obtaining the best available risk assessment for purposes of elaborating safe conditions of use for food additives and elaborating safe maximum levels or codes of practice for contaminants and naturally occurring toxicants in food.
20) CCFAC shall consider the following when preparing its priority list of substances for JECFA review:
- Consumer protection from the point of view of health and prevention of unfair trade practices;
- CCFAC's Terms of Reference;
- JECFA's Terms of Reference;
- The Codex Alimentarius Commission's Strategic Plan, its relevant plans of work and Criteria for the Establishment of Work Priorities;
- The quality, quantity, adequacy, and availability of data pertinent to performing a risk assessment, including data from developing countries;
- The prospect of completing the work in a reasonable period of time;
- The diversity of national legislation and any apparent impediments to international trade;
- The impact on international trade (i.e., magnitude of the problem in international trade);
- The needs and concerns of developing countries; and,
- Work already undertaken by other international organizations;
21) When referring substances to JECFA, CCFAC shall provide background information and clearly explain the reasons for the request when chemicals are nominated for evaluation;
22) CCFAC may also refer a range of risk management options, with a view toward obtaining JECFA's guidance on the attendant risks and the likely risk reductions associated with each option.
23) CCFAC requests JECFA to review any methods and guidelines being considered by CCFAC for assessing maximum use levels for additives or maximum levels for contaminants and naturally occurring toxicants. CCFAC makes any such request with a view toward obtaining JECFA's guidance on the limitations, applicability, and appropriate means for implementation of a method or guideline for CCFAC's work.
SECTION 4. JECFA
24) JECFA is primarily responsible for performing the risk assessments upon which CCFAC and ultimately the CAC base their risk management decisions.
25) JECFA's scientific experts should be selected on the basis of their competence and independence, taking into account geographical representation to ensure that all regions are represented.
26) JECFA should strive to provide CCFAC with science-based risk assessments that include the four components of risk assessment as defined by CAC and safety assessments that can serve as the basis for CCFAC's risk-management discussions. For contaminants and naturally occurring toxicants, JECFA should determine to the extent possible the risks associated with various levels of intake. Because of the lack of appropriate information, including data in humans, however, this may be possible in only a few cases for the foreseeable future. For additives, JECFA should continue to use its safety assessment process for establishing ADIs.
27) JECFA should strive to provide CCFAC with science-based quantitative risk assessments and safety assessments for food additives, contaminants, and naturally occurring toxicants in a transparent manner.
28) JECFA should provide CCFAC with information on the applicability and any constraints of the risk assessment to the general population to particular sub-populations and should as far as possible identify potential risks to populations of potentially enhanced vulnerability (e.g., children, women of child-bearing age, the elderly).
29) JECFA should also strive to provide CCFAC with specifications of identity and purity essential to assessing risk associated with the use of additives.
30) JECFA should strive to base its risk assessments on global data, including data from developing countries. These data should include epidemiological surveillance data and exposure studies.
31) JECFA is responsible for evaluating exposure to additives, contaminants, and naturally occurring toxicants.
32) When evaluating intake of additives or contaminants and naturally occurring toxicants during its risk assessment, JECFA should take into account regional differences in food consumption patterns.
33) JECFA should provide to CCFAC its scientific views on the validity and the distribution aspects of the available data regarding contaminants and naturally occurring toxicants in foods which have been used for exposure assessments, and should give details on the magnitude of the contribution to the exposure from specific foods as may be relevant for risk management actions or options of CCFAC.
34) JECFA should communicate to CCFAC the magnitude and source of uncertainties in its risk assessments. When communicating this information, JECFA should provide CCFAC with a description of the methodology and procedures by which JECFA estimated any uncertainty in its risk assessment.
35) JECFA should communicate to CCFAC the basis for all assumptions used in its risk assessments including default assumptions used to account for uncertainties.
36) JECFA's risk assessment output to CCFAC is limited to presenting its deliberations and the conclusions of its risk assessments and safety assessments in a complete and transparent manner. JECFA's communication of its risk assessments should not include the consequences of its analyses on trade or other non-public health consequence. Should JECFA include risk assessments of alternative risk management options, JECFA should ensure that these are consistent with the Working Principles for Risk Analysis for the Application in the Framework of the Codex Alimentarius and Risk Analysis Principles applied by the Codex Committee on Food Additives and Contaminants.
37) When establishing the agenda for a JECFA meeting, the JECFA Secretariat work closely with CCFAC to ensure that CCFAC's risk management priorities are addressed in a timely manner. With respect to food additives, the JECFA Secretariat should normally give first priority to compounds that have been assigned a temporary ADI, or equivalent. Second priority should normally be given to food additives or groups of additives that have previously been evaluated and for which an ADI, or equivalent, has been estimated, and for which new information is available. Third priority should normally be given to food additives that have not been previously evaluated. With respect to contaminants and naturally occurring toxicants, the JECFA Secretariat should give priority to substances that present both a significant risk to public health and are a known or expected problem in international trade.
38) When establishing the agenda for a JECFA meeting, the JECFA Secretariat should give priority to substances that are known or expected problems in international trade or that present an emergency or imminent public health risk.
SECTION 1. INTRODUCTION
1. Maximum Limits (MLs) do not need to be set for all foods that contain a contaminant or a toxin. The Preamble of the Codex General Standard for Contaminants and Toxins in Foods (GSCTF) states in Section 1.3.2 that "maximum levels (MLs) shall only be set for those foods in which the contaminant may be found in amounts that are significant for the total exposure of the consumer. They should be set in such a way that the consumer is adequately protected". Setting standards for foods that contribute little to dietary exposure would mandate enforcement activities that do not contribute significantly to health outcomes.
2. Exposure assessment is one of the four components of risk assessment within the risk analysis framework adopted by Codex as the basis for all standard-setting processes. The estimated contribution of specific foods or food groups to the total dietary exposure to a contaminant as it relates to a quantitative health hazard endpoint (e.g., PMTDI, PTWI) provides further information needed for the setting of priorities for the risk management of specific foods/food groups. Exposure assessments must be guided by clearly articulated policies elaborated by Codex with the aim of increasing the transparency of risk management decisions.
3. The purpose of this Annex is to outline steps in contaminant data selection and analysis undertaken by JECFA when requested by CCFAC to conduct a dietary exposure assessment.
4. The following components highlight aspects of JECFA's exposure assessment of contaminants and toxins that contribute to ensuring transparency and consistency of science-based risk assessments. Exposure assessments of contaminants and toxins in foods are performed by JECFA at the request of CCFAC. CCFAC will take this information into account when considering risk management options and making recommendations regarding contaminants and toxins in foods.
SECTION 2. ESTIMATION OF TOTAL DIETARY EXPOSURE TO A CONTAMINANT OR TOXIN FROM FOODS/FOOD GROUPS
5. JECFA uses available data from member countries and from GEMS/Food Operating Program for analytical laboratories system on contaminant levels in foods and the amount of foods consumed to estimate total dietary exposure to a contaminant or toxin. This is expressed as a percentage of the tolerable intake (e.g., PTDI, PTWI, or other appropriate toxicological reference point). For a carcinogen with no clear threshold, JECFA uses available data on intake combined with data on carcinogenic potency to estimate potential population risks.
6. Median/mean contaminant levels in foods are determined from available analytical data submitted by countries and from other sources. These data are combined with information available for the GEMS/Food Regional diets to generate dietary exposure estimates for regions in the world. JECFA provides an estimate as to which of the GEMS/Food Regional diets are likely to approach or exceed the tolerable intake.
7. In some cases, available national contaminant and/or individual food consumption data may be used by JECFA to provide more accurate estimates of total dietary exposure, particularly for vulnerable groups such as children.
8. JECFA performs exposure assessments if requested by CCFAC using the GEMS/Food Regional Diets and, if needed, available national consumption data to estimate the impact on dietary exposure of proposed alternative maximum levels to inform CCFAC about these risk management options.
SECTION 3. IDENTIFICATION OF FOODS/FOOD GROUPS THAT CONTRIBUTE SIGNIFICANTLY TO TOTAL DIETARY EXPOSURE OF THE CONTAMINANT OR TOXIN
9. From dietary exposure estimates JECFA identifies foods/food groups that contribute significantly to the exposure according to CCFAC's criteria for selecting food groups that contribute to exposure.
10. The CCFAC determines criteria for selecting foods/food groups that contribute significantly to total dietary exposure of a contaminant or toxin. These criteria are based upon the percentage of the tolerable intake (or similar health hazard endpoint) that is contributed by a given food/food group and the number of geographic regions (as defined by the GEMS/Food Regional diets) for which dietary exposures exceed that percentage.
11. The criteria are as follows:
a) Foods or food groups for which exposure to the contaminant or toxin contributes approximately 10% or more of the tolerable intake (or similar health hazard endpoint) in one of the GEMS/Food Regional diets;
b) Foods or food groups for which exposure to the contaminant or toxin contributes approximately 5%1 or more of the tolerable intake (or similar health hazard endpoint) in two or more of the GEMS/Food Regional diets;
c) Foods or food groups that may have a significant impact on exposure for specific groups of consumers, although exposure may not exceed 5% of the tolerable intake (or similar health hazard endpoint) in any of the GEMS/Food Regional diets. These would be considered on a case-by-case basis.
SECTION 4. GENERATION OF DISTRIBUTION CURVES FOR CONCENTRATIONS OF THE CONTAMINANT IN SPECIFIC FOODS/FOOD GROUPS (CONCURRENT WITH SECTION 2, OR SUBSEQUENT STEP)
12. If requested by CCFAC, JECFA uses available analytical data on contaminant or toxin levels in foods/food groups identified as significant contributors to dietary exposure to generate distribution curves of contaminant concentrations in individual foods. CCFAC will take this information into account when considering risk management options and, if appropriate, for proposing the lowest achievable levels for contaminants/toxins in food on a global basis.
13. Ideally, individual data from composite samples or aggregated analytical data would be used by JECFA to construct the distribution curves. When such data are not available, aggregated data would be used (for example mean and geometric standard deviation). However, methods to construct distribution curves using aggregated data would need to be validated by JECFA.
14. In presenting the distribution curves to CCFAC, JECFA should, to the extent possible, provide a comprehensive overview of the ranges of contamination of foods (i.e., both the maximum and outlier values) and of the proportion of foods/food groups that contain contaminants/toxins at those levels.
SECTION 5. ASSESSMENT OF THE IMPACT OF AGRICULTURAL AND PRODUCTION PRACTICES ON CONTAMINANT LEVELS IN FOODS/FOOD GROUPS (CONCURRENT WITH SECTION 2, OR SUBSEQUENT STEP)
15. If requested by CCFAC, JECFA assesses the potential impact of different agricultural and production practices on contaminant levels in foods to the extent that scientific data are available to support such assessments. CCFAC takes this information into account when considering risk management options and for proposing Codes of Practice.
16. Taking this information into account, CCFAC proposes risk management decisions. To refine them, CCFAC may request JECFA to undertake a second assessment to consider specific exposure scenarios based on proposed risk management options. The methodology for assessing potential contaminant exposure in relation to proposed risk management options needs to be further developed by JECFA.
 See Appendix: General
Decisions of the Commission|
 See Definitions of Risk Analysis Terms Related to Food Safety.
 For the purpose of the present document, the term "interested parties" refers to "risk assessors, risk managers, consumers, industry, the academic community and, as appropriate, other relevant parties and their representative organizations" (see definition of "Risk Communication")
 Reference is made to the Statements of Principle Relating to the Role of Food Safety Risk Assessment: See Appendix: General Decisions of the Commission.
 For the purpose of these Principles, preliminary risk management activities are taken to include: identification of a food safety problem; establishment of a risk profile; ranking of the hazard for risk assessment and risk management priority; establishment of risk assessment policy for the conduct of the risk assessment; commissioning of the risk assessment; and consideration of the result of the risk assessment.
 See Appendix: General Decisions of the Commission.
 A Safety Assessment is defined as a scientifically-based process consisting of: 1) the determination of a NOEL (No Observed Effect Level) for a chemical, biological, or physical agent from animal feeding studies and other scientific considerations; 2) the subsequent application of safety factors to establish an ADI or tolerable intake; and 3) comparison of the ADI or tolerable intake with probable exposure to the agent (Temporary definition to be modified when JECFA definition is available).
 Rounded to the nearest 1/10th of a percent.