When the population at risk includes infants, young children, the elderly, or immunocompromised individuals, should the evidentiary threshold for voluntary recall be lower than it would be for a product consumed primarily by healthy adults?

Answer Explanations

• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-3716
  When vulnerable populations such as infants, the elderly, or immunocompromised individuals are at risk, the potential health outcomes are often more severe, including irreversible complications or death. In such cases, adopting a lower evidentiary threshold for precautionary action is justified both scientifically and ethically. The consequences of a false negative—failing to act in time—can be far more serious and irreversible than those of a false positive, such as an unnecessary recall. Therefore, public health decision-making should prioritize minimizing harm in high-risk populations, even in the presence of some uncertainty
• Population vulnerability is already implicitly incorporated through severity weighting in any competent risk assessment. Explicitly adjusting the evidentiary threshold is unnecessary if the risk framework properly accounts for consequence severity.

  user-957551
  The first choice and last choice overlap, but I chose the last choice because similar to pesticide risk assessment, variability in population demographics by age category is built into the level of concern decisions.  Thus, evidence should be as high as feasible but action is based on a level of concern that has already been adjusted to account for demographic differences.
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-37602
  Pathogens of interest can cause severe, irreversible and on some cases death in special vulnerable populations, even at low exposure levels. With the heightened susceptibility and limited capacity for recovery in these groups, lowering the evidentiary threshold for recall aligns with risk-based decision-making that prioritizes prevention of severe harm over the consequences of precautionary action.
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-210880
  When potential outcomes include severe or irreversible harm, the evidentiary threshold for action should be lowered. Risk is not determined solely by the probability of causation but by the magnitude of consequences.
  In vulnerable populations, the cost of a false negative (continued exposure) is significantly higher than that of a false positive (unnecessary recall). Therefore, precautionary action based on strong epidemiological signals is both scientifically and ethically justified.
  This principle aligns with decision-making in other high-risk domains, where actions are often taken under uncertainty when the potential consequences are severe.
  A similar approach is applied in clinical radiopharmaceutical practice, where decisions must sometimes be made before complete analytical confirmation when patient safety is at stake.
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-69551
   

  Which is to say, the main point here, to be clear: The consequences are asymmetrical. However, when certain vulnerable populations  especially infants or the elderly are subject to lethal or irreversible threat (for example, HUS due to E. coli O157:H7, respiratory failure due to infant botulism, or listeriosis mortality) the cost of inaction dwarfs the cost of recalls done without any need. The financial loss is a false positive  recalling a safe product, then enduring a financial injury that can be recouped. A false negative  failure to recall a hazardous product leads to irreversible organ damage or death. This asymmetry causes the evidentiary threshold to be lowered when the vulnerable population is at particular risk. The latest case information supports it: the global precautionary recall of infant formula tainted with cereulide in late 2025 was undertaken even before EFSA had reached full scientific thresholds, purely on grounds of who was at risk the newborn population. 
  
  
• The vulnerability of the population should affect the speed of the response, not the threshold of evidence required. The same standard of evidence applies, but the timeline for decision-making should be compressed when vulnerable populations are exposed.

  user-414344
  Again, this has to be a considered and living process and adjusted to address the issue of vulnerability, exposure risk, and analytical data.
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-890708
  I think so too。
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-15416
  vulnerable population are presentes in our society
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-157767
   -Regulatory authorities must also consider vulnerable populations, such as children, the elderly, and immunocompromised individuals, who may experience more severe outcomes even at lower levels of contamination. 
• No. The evidentiary standard should be consistent regardless of the population at risk. Adjusting thresholds based on population vulnerability introduces subjectivity into what should be an evidence-based process and could lead to over-recall of products consumed by vulnerable groups.

  user-683654
  The type of population mostly affected should be first determined.
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-789652
  Vulnerable populations (infants, elderly, immunocompromised) can suffer disproportionately severe or irreversible outcomes from pathogens. In these cases, public health decision-making favors precaution. Reducing the evidentiary threshold for recalls balances the ethical obligation to prevent serious harm against the economic and logistical costs of unnecessary recalls. 
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-353654
  See above
• Yes. When potential outcomes include death or irreversible organ damage in vulnerable populations, a lower evidentiary threshold for precautionary action is scientifically and ethically justified. The cost of a false positive (unnecessary recall) is recoverable; the cost of a false negative (continued exposure) may not be.

  user-958242
  Strongly , recommend the population at risk including  infants, young children, the elderly, or immunocompromised individuals, should have the  lower evidentiary threshold for voluntary recallfor product
  
  This is ethical principle , Prevention is always better than cure , so no doubt beyond thatand that for these at Population at risk.