Key Considerations To Facilitate Food Safety Assessments In Situations Of Low Level Presence

1. Context

• The Codex Alimentarius Commission (Codex) outlines a structured approach for risk analysis within its framework^{Footnote 1}, comprised of risk assessment, risk management, and risk communication components. Codex further elaborates risk analysis principles specific to foods derived from modern biotechnology^{Footnote 2}.
• According to these principles, risk assessment is based on the best available science and should incorporate hazard identification, hazard characterization, exposure assessment and risk characterization.
• Codex guidance on risk assessment of foods derived from modern biotechnology notes that it includes a safety assessment designed to identify and characterize hazards, and that results of risk assessments undertaken by other regulatory authorities may be used to assist in the risk analysis where appropriate and avoid duplication of work.
• Codex guidance states that risk management decisions should be based on risk assessment and may take into account other legitimate factors for health protection and promotion of fair trade, such as relevant production, storage and handling practices in the food chain. Thus risk management may incorporate policy considerations in addition to scientific risk assessment conclusions.
• The Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants CAC/GL 45-2003, Annex 3: Food Safety Assessment in Situations of Low-Level Presence of Recombinant-DNA Plant Material in Food ("Codex Annex 3")^{Footnote 3} sets out criteria for undertaking low-level presence (LLP) safety assessments. It does not include guidance on other aspects of risk assessment (that is, exposure assessment and risk characterization) for LLP situations, nor does it address risk management.
• This document provides key principles and best practices to ensure efficiency and effectiveness in safety assessment, risk assessment and risk management of LLP situations compliant with Codex guidelines for risk analysis.
• The guidance in this document is not intended to supplant or replace Codex guidance, nor to supplant or replace any domestic laws or regulations.
• This document is intended to complement the GLI statement "Practical Approaches to Managing LLP in Food and Feed Imports" (2017). It assumes that an overarching principle for LLP risk management is to ensure food safety while minimizing trade disruption. It also acknowledges that LLP risk management measures do not preclude the need to secure full food and feed authorizations according to national legislation, and should include corrective actions to bring LLP violations into compliance.

2. Principles for LLP food safety assessments (hazard identification and characterization)

• LLP safety assessments should be carried out by government officials as efficiently as possible, particularly when performed in response to a recent discovery of LLP in their country, to ensure that appropriate risk management decisions can be taken in a timely manner.
• LLP safety assessments may be performed as due diligence by the importing country to confirm another country's Codex-compliant determination of safety of the r-DNA event present at low-level.
• LLP safety assessments should be based on scientific evidence. Importing countries may access information for LLP safety assessments through:
  • direct engagement with stakeholders including the developer of the LLP event, importing companies, and exporting governments;
  • databases such as the FAO GM Foods Platform;
  • publicly available summaries of safety assessments used by another country or countries; and
  • publicly available full safety assessments undertaken by another country or countries.
• Documentations of Codex-compliant assessments carried out by other countries, or full data packages submitted for these assessments, are a good source of information for LLP safety assessments where these are available. Provided that the importing country is satisfied that Codex guidelines have been followed in these assessments, the importing country may choose not to undertake an LLP safety assessment itself. This option may allow countries with limited resources to ensure food safety while minimizing trade disruptions.
• Where data cannot be received in a timely manner, safety assessors may also make use of their familiarity with the event and its characteristics, as well as valid scientific rationale and other existing relevant data including:
  • valid summaries of data or data analyses where raw data is not available;
  • any available information on the possible toxicity and possible allergenicity of any newly expressed substance(s) found in the specific event in question, particularly where these are also found in other food with a history of use or in food previously approved according to Codex guidelines;
  • and any other available information on the overall safety of the specific event in question.
• In assessing LLP safety, regulators may consider a weight of evidence approach, relying on strong evidence regarding the overall safety of the food and its intended novel components. This approach may be used if all data listed in Codex Annex 3 cannot be received in a timely manner.
• Industry is encouraged to proactively or reactively provide data for LLP safety assessments, in a language appropriate for the importing country, to facilitate timely LLP safety assessments.
• In undertaking LLP safety assessments, countries are recommended to seek:
  • close collaboration among national government departments responsible for health, food inspection and grain handling to ensure efficient and timely LLP identification and safety assessments;
  • timely advice from independent national and international experts regarding safety assessment procedures and conclusions;
  • consultation on LLP risk assessment procedures and transparency with the public regarding LLP decisions;
  • engagement with product developer(s), grain and food industry to ensure timely access to data and information; and
  • cooperation among countries, particularly between exporting and importing countries, to ensure timely access to data and information.
• LLP safety assessments may be undertaken proactively, in preparation for possible future LLP incidents, or in response to actual LLP incidents.

3. Principles for LLP risk assessment (safety assessment plus exposure assessment and risk characterization)

• According to Codex guidelines, risk assessment takes into account identification and characterization of the hazard posed by the LLP material as determined by LLP safety assessment, as well as the exposure and overall risk characterization.
• The result of LLP risk assessment is a risk estimate that the LLP does, or does not, pose a food risk if present in imported shipments at low levels (that is, extremely low exposure).
• Level of exposure is taken into account in LLP risk assessment even when formal thresholds are not applied. Exposure takes into account the percentage of LLP to non-LLP material in a shipment as well as the expected food and feed uses of the shipment.
• If a full LLP safety assessment is not possible, an LLP risk assessment conclusion of "negligible risk" must be supported at a minimum by safety assessment of scientifically valid data on the allergenicity (for proteins) and toxicity of all newly expressed substances in the LLP material, as prescribed in Codex Annex 3.
• Inconclusive results for some other aspects of a Codex Annex 3 safety assessment should be interpreted in light of the low levels of exposure in LLP situations.
• Taking into account exposure, an LLP risk assessment conclusion of "negligible risk" may be made for shipments with LLP of which no toxicity and allergenicity concerns have been identified for any newly expressed substances, even when adequate assessments are unavailable for some other aspects of Codex Annex 3 such as for example:
  • Characterization of the level and site of expression of the expressed gene product and its metabolites;
  • Analyses of unintended changes to endogenous toxicants and allergens; and
  • Evaluation of unintended changes to metabolites.

4. Principles of LLP risk management

• LLP risk management decisions should be determined by the risk characterization conclusion reached as a result of the risk assessment.
• When an LLP risk assessment concludes that the situation poses no food safety risk, risk management measures should not be unduly trade-disruptive.
• Efforts should be made to take risk management decisions as timely as possible.
• Risk management approaches based on previous proactively completed LLP safety assessments may consist solely of administrative or verification measures as well as non-trade disruptive enforcement and compliance promotion activities, and are therefore more trade-facilitating than approaches requiring reactive risk assessment.

Date modified:

2020-11-17