This article is the sequel 2 of”The United States intends to strengthen the control of toxic heavy metals in foods for infants and young children.” The introduction of the category and level value setting plan is mainly centered on the”Infant and Young Children’s Food Exposure Reduction Plan” issued by the US FDA on April 8, 2021.
1. Overview of the FDA Action Plan
On March 5, 2021, the FDA shared with the public the latest status of its efforts to improve the safety of foods for infants and young children:In the coming weeks, the FDA will share plans to reduce the level of toxic elements in food for the industry Provide information on the FDA’s future work on this important issue. On April 8, 2021, the FDA released an action plan to reduce the level of toxic elements in food to”near zero” in three time periods based on four phases of iterative scientific continuous improvement methods as scheduled.
The”near zero” action plan intends to further reduce the content of toxic elements in food through the following measures:
(1) Promote FDA’s research and evaluation of changes in dietary exposure to toxic elements;
(2) Set the action level based on the opinions of stakeholders;
(3) Encourage industry to adopt best practices to reduce the content of toxic elements in agricultural commodities and agricultural products;
(4) Increase targeted compliance and law enforcement activities; and
(5) Advance the progress of monitoring level over time.
2. The 4 phases and 3 time periods of the FDA action plan adoption method
(1) Four stages of iterative scientific method
In order to achieve continuous improvement, the FDA’s action plan follows a four-phase iterative approach, which includes research, supervision, and extension work.
The first stage:the scientific basis for evaluating the level of action.
Evaluate existing routine tests from the food supply, research and data on chemical analysis methods, toxicological analysis, exposure and risk assessment, and other relevant scientific information, and negotiate with stakeholders to provide These toxic elements establish appropriate interim reference levels (IRLs).
The second stage:propose the level of action.
Based on the provisional reference level, propose action levels for toxic elements in baby food (such as cereals, infant formula, fruit juice, vegetable juice, etc.) and other foods commonly eaten by infants and young children.
Note:The action level is set by the FDA to provide guidance to industry and FDA field staff. According to section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, the action level is a level of food contamination that can be considered adulteration. When considering whether to take compliance or compulsory actions in a specific situation, the regulator must consider the level of action in addition to other factors. Over time, the level of action can be appropriately reduced.
The third stage:Consultation with stakeholders on the level of action
Solicit opinions from stakeholders on the proposed action level (including the achievability and feasibility of the action level). For each toxic element in each type of food, collect data and other information through a consultation process.
The fourth stage:complete the final action level
FDA will make any necessary adjustments to determine the level of action based on the information collected from stakeholders, the latest scientific research and routine monitoring of data.
Once the FDA has determined and announced the final level of action, it will establish a timetable for evaluating the industry’s progress in reaching the level of action, and restart the cycle of improvements to determine whether scientific data supports further downward adjustments to the level of action, thereby Make the action level value”close to zero”.
(2) Proposed timetable for action plan
The FDA action plan intends to achieve the improvement goal through continuous improvement in 3 time periods. In each time period, it will be carried out in sequence according to the four phases of evaluation, proposal, negotiation and determination. The specific implementation is shown below.
Among them, the”assessment” link at each stage basically evaluates the existing data corresponding to the toxic elements, and negotiates with related parties to establish their temporary reference level; the”proposal” link is for infants and young children. Draft of action levels for toxic elements; the”negotiation” link is to negotiate with stakeholders the feasibility and best practices of the action levels of such toxic elements in food; the”finish” link is to finalize the food consumption of infants and young children The level of action of such toxic elements.
In addition, the”Continuous Monitoring, Research and Compliance” link at each stage will involve the issuance of relevant guidance documents and other work arrangements. The detailed information is as follows:
At that time, with the final determination of the action level, the FDA will continue the cycle of continuous improvement, successively assessing whether each toxic element should be adjusted downwards to the temporary reference level; propose a new action level as appropriate; in terms of feasibility and feasibility Negotiate other issues with stakeholders; and adjust (as needed) and finalize the level of action.
In the process of advancing the action plan, FDA will cooperate with multiple departments in various aspects to make unremitting efforts to promote the cycle of the plan. The content of cooperation includes:the management of toxic elements at the source of agricultural products, and the effects of toxic elements on babies and infants The impact of children’s growth and development and the mitigation of nutrients; evaluating new technologies to reduce related consumption exposure; developing and verifying new analytical methods, etc.
3. Summary of the core FDA’s key work in the next year
(1) Focus on assessing lead and arsenic, which have the most relevant data available, and propose action levels for the lead content in foods consumed by infants and young children and negotiate their feasibility.
(2) The action level of lead is mainly for infant foods (such as cereals, infant formula, fruit and vegetable puree, etc.) and other foods commonly eaten by infants and young children.
(3) Complete the latest sampling task to test the levels of toxic elements in foods for infants and young children, and evaluate scientific information related to arsenic exposure in foods other than baby rice noodles.
(4) Continue to study other elements, and over time, study each element in various foods eaten by babies and young children.
In the future, the FDA will carry out relevant work in accordance with the first phase plan, conduct research and cooperation with related parties, and finally determine the action level of arsenic in apple juice, and will release a draft action level of lead in juice in the near future. Evaluate the potential impact of new technologies, interventions and technologies, or take mitigation control measures to reduce exposure, and reassess the risk based on the decrease in the content of toxic elements in food.
Food Partners Network urges relevant parties to focus on and control the levels of lead and arsenic in foods for infants and young children (such as cereals, infant formula, fruit and vegetable purees) and other foods commonly eaten by infants and young children. Gradually put the prevention and control of heavy metals and other toxic elements in the production process on the agenda, systematically carry out verification activities that are not limited to the final product test, and finally follow up or follow the FDA action plan to reduce the content of toxic elements in baby and young children’s food Reduce to”near zero”. In the future, Food Partner Network will continue to follow the progress of the FDA’s work in the first phase of the action plan, and share key content with you in a timely manner.
Related reports:The United States intends to strengthen the control of toxic heavy metals in foods for infants and young children