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Chapter 6 : Integrating Concepts: a Case Study Using in Infant Formula

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Abstract:

This chapter reviews the risk assessment activities that have been performed on and focuses on the relations between the various concepts. Other food products besides powdered infant formula (PIF), such as breast milk, starch, and commercially sterilized liquid infant formula, have been described as potentially causing infections. One of the potential control measures to reduce the risk of is setting microbiological criteria (MC) for PIF. When a microbial criterion is in place, batches of product need to be sampled at the end of manufacturing, e.g., at packaging, prior to storage. The risk assessment model (RAModel) predicts the number of illnesses due to per million infant-days, resulting from feeding reconstituted PIF, and compares this number with the numbers resulting from a baseline scenario. Risk communication from users to risk managers is also required. To be able to weigh the various options for control measures, it is imperative that the actual preparation and handling practices become known. Risk assessors can then use the RAModel to compare the options, based on better assumptions regarding temperature, holding times, and cooling rates. Consequently risk managers may be able to design and implement control measures that will effectively reduce the risk, but at the same time take into account all the relevant factors to make sure that the control measures will be feasible and acceptable and can be applied for those infants who are currently most at risk.

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6

Key Concept Ranking

Quantitative Risk Assessment
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Risk Analysis Framework
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Risk Assessment
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Risk Management
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Risk Communication
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Food Safety
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Figures

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Figure 1

Examples of factors relevant for risk assessment, risk management, and risk communication (not exhaustive).

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 2

Schematic view of infant formula production with various options to add ingredients.

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 3

Overview of various methods of handling, storing, and using PIF.

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 4

Square root of measured and fitted specific growth rates as function of the temperature. Bullets represent growth rates published by: , ; +, ; ∠, . The line represents a fit by the secondary-growth model of Rosso (fitted to square root of transformed data of the first publication only). The resulting parameter values are: = 3.60°C; = 47.6°C; = 39.4°C; μ = 2.31 h. Adapted from .

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 5

Example of a temperature profile that was generated by the RAModel ( ) based on a scenario for reconstituting PIF for 15 min, cooling the bottle for 4 h, rewarming for 15 min, and feeding at 30°C for prolonged time (2 h).

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 6

Illustration of the microbial quality distribution of various (hypothetical) categories of PIF on the market. The brands are assumed to fall into three levels of microbial quality, representing best (category A, — · — ·), moderate (category B, ——), and poor (category C, — — —). The vertical line represents an arbitrary MC. Adapted from .

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 7

(a) Risk reduction rates and (b) rejection rates, as estimated to result from the application of two-class sampling plans, with = 3, 5, 10, 30, or 50 samples per lot. Each lot is sampled and the sample size is 10 g. The mean log concentrations of the PIF are assumed to be −3 log CFU/g (category C, triangles), −4 log CFU/g (category B, diamonds), or −5 log CFU/g (category A, squares). The between-lot variability (σ) is 0.5 (closed markers) and 0.8 (open markers). Risk reduction is relative to no sampling. Data were taken from .

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 8

Relative risk of reconstituting PIF with water of various temperatures. Risk is relative to the same baseline scenario as in Table 3 . Data were taken from .

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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Figure 9

Relative risk associated with placing the bottle of formula in refrigerators with various air temperatures for 4 h, then rewarming to 37°C and feeding for an extended period of 2 h in a warm room at 30°C. Bottles are reconstituted with water of 10°C (×), 30°C (□), and 50°C (▲). Data were taken from . The baseline scenario for series is refrigeration at 2°C.

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
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References

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Tables

Generic image for table
Table 1

Reported cases of infections in The Netherlands over a period of 40 years and the resulting relative susceptibilities and upper-limit -values for the various weight categories

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
Generic image for table
Table 2

Cases of infections reported worldwide over a period of 40 years and the resulting relative susceptibilities for the various weight categories

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
Generic image for table
Table 3

Relative increase in risk of different preparation, storage, and handling practices for formula at warm ambient temperature (30°C)

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
Generic image for table
Table 4

Effect of the duration of feeding on relative risk

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6
Generic image for table
Table 5

Relative risk associated with reconstituting PIF in bottles and in containers of 1 and 25 liters

Citation: Reij M, Zwietering M. 2008. Integrating Concepts: a Case Study Using in Infant Formula, p 177-204. In Schaffner D, Doyle M (ed), Microbial Risk Analysis of Foods. ASM Press, Washington, DC. doi: 10.1128/9781555815752.ch6

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