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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">JFSH</journal-id>
      <journal-title-group>
        <journal-title>Journal of Food Science and Hygiene</journal-title>
      </journal-title-group>
      <issn pub-type="epub">2835-2165</issn>
      <publisher>
        <publisher-name>Open Access Pub</publisher-name>
        <publisher-loc>United States</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="doi">10.14302/issn.2835-2165.jfsh-18-2162</article-id>
      <article-id pub-id-type="publisher-id">JFSH-18-2162</article-id>
      <article-categories>
        <subj-group>
          <subject>letter</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Quantitative Microbiological Risk Assessment: Underrated Tool in Process Improvement in Food Microbiology</article-title>
        <alt-title alt-title-type="running-head">qmra: indispensible technique in food industry journal id jfsh doi: 10.14302/issn.2835-2165.jfsh-18-2162</alt-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <name>
            <surname>Mostafa</surname>
            <given-names>Essam Eissa</given-names>
          </name>
          <xref ref-type="aff" rid="idm1849295676">1</xref>
          <xref ref-type="corresp" rid="cor1">*</xref>
        </contrib>
      </contrib-group>
      <aff id="idm1849295676">
        <label>1</label>
        <addr-line>Independent PhD Researcher, Faculty of Pharmacy, Cairo University, Cairo, Egypt</addr-line>
      </aff>
      <contrib-group>
        <contrib contrib-type="editor">
          <name>
            <surname>Foluso</surname>
            <given-names>Oluwagbemiga Osunsanmi</given-names>
          </name>
          <xref ref-type="aff" rid="idm1849154396">1</xref>
        </contrib>
      </contrib-group>
      <aff id="idm1849154396">
        <label>1</label>
        <addr-line>University of Zululand, South Africa</addr-line>
      </aff>
      <author-notes>
        <corresp id="cor1">Correspondence: Mostafa Essam Ahmed Mostafa Eissa, Microbiology and Immunology Department, Faculty of Pharmacy, Cairo University, Cairo, Egypt; Tel: +2 010 0615 4853; Email: <email>mostafaessameissa@yahoo.com</email>.</corresp>
        <fn fn-type="conflict" id="idm1840755828">
          <p>The authors have declared that no competing interests exist.</p>
        </fn>
      </author-notes>
      <pub-date pub-type="epub" iso-8601-date="2018-06-20">
        <day>20</day>
        <month>06</month>
        <year>2018</year>
      </pub-date>
      <volume>1</volume>
      <issue>1</issue>
      <fpage>12</fpage>
      <lpage>15</lpage>
      <history>
        <date date-type="received">
          <day>08</day>
          <month>06</month>
          <year>2018</year>
        </date>
        <date date-type="accepted">
          <day>14</day>
          <month>06</month>
          <year>2018</year>
        </date>
        <date date-type="online">
          <day>20</day>
          <month>06</month>
          <year>2018</year>
        </date>
      </history>
      <permissions>
        <copyright-statement>© </copyright-statement>
        <copyright-year>2018</copyright-year>
        <copyright-holder>Mostafa Essam Eissa, et al.</copyright-holder>
        <license xlink:href="http://creativecommons.org/licenses/by/4.0/" xlink:type="simple">
          <license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</license-p>
        </license>
      </permissions>
      <self-uri xlink:href="http://openaccesspub.org/jfsh/article/779">This article is available from http://openaccesspub.org/jfsh/article/779</self-uri>
      <abstract>
        <p>This article advocates for routine use of quantitative microbiological risk assessment to strengthen process control. It illustrates how modeling hazard levels and uncertainty informs critical limits, verification, and continuous improvement.</p>
      </abstract>
      <counts>
        <fig-count count="1"/>
        <table-count count="1"/>
        <page-count count="4"/>
      </counts>
    </article-meta>
  </front>
  <body>
    <sec id="idm1849159940" sec-type="intro">
      <title>Introduction</title>
      <p>Sir,</p>
      <p>Microbial contamination of food has been responsible either as isolated cases or outbreaks for many human illnesses and even deaths over long years of man march on the earth. Over long years, it was possible to invent many techniques and technologies that control bioburden in the food material to avoid adverse impact on the life of the consumers. During recent years, useful tools were adopted to provide a mean for the assessment of the hazard to the human health encountered from exposure to pathogenic microbes. Taking into consideration, several factors such as dose-response model of infection, affected populations, the impact of processing conditions of food and cross-contamination <xref ref-type="bibr" rid="ridm1849330076">1</xref>.</p>
      <p>Using mean that provide an objective method to estimate the microbiological risk was a subject of interest for decades. At the beginning of the twentieth century, early attempts were made to cover concerns about the microbiological quality issues of water and food <xref ref-type="bibr" rid="ridm1849324820">2</xref>. To cover this challenge, the concept of 'indicator microbe' was developed and adopted in food industry such as in milk and other industries <xref ref-type="bibr" rid="ridm1849332244">3</xref>. Perhaps the coliform group of microorganisms was the first to be used to apply this concept <xref ref-type="bibr" rid="ridm1849406396">4</xref><xref ref-type="bibr" rid="ridm1849185572">5</xref>. However, this tool was imperfect till now and suffer limitations as the absence of the indicator microbes is not guarantee for the absence of the pathogenic microorganisms <xref ref-type="bibr" rid="ridm1849181396">6</xref>. Moreover, the establishment of health standards based on indicator microorganisms requires extensive epidemiological surveillance which is quite expensive to perform and suffers from a limitation in the detection limits. <xref ref-type="bibr" rid="ridm1849324820">2</xref>. </p>
      <p>The search for a better and objective methodology was sought to the avoid limitation of indicator method. The utilization of microbial hazard appraisal in a quantitative manner will empower coordinate estimations of pathogens to be utilized to create pass/fail rules for nourishment, water, and different vehicles that might be the wellspring of microbial introduction to human populace <xref ref-type="bibr" rid="ridm1849324820">2</xref>. There might be various goals for the assessment of the microbial risk objectively. These targets identify with the method of reasoning for the execution of the assessment, and the techniques to be utilized. Extensively, the distinctive destinations reflect diverse scales at which a hazard evaluation might be performed. The progression of issue plan is basic to any hazard gauge <xref ref-type="bibr" rid="ridm1849186076">7</xref>.  </p>
      <p>A prominently useful tool in food microbiology comes into play which has an important role in providing an objective measurement of the health hazard risk encountered from consumption of contaminated food by hazardous microbes. This tool is called Quantitative Microbiological Risk Assessment (QMRA). Despite its few limitations, yet it provides a crucial role in decision making <xref ref-type="bibr" rid="ridm1849169372">8</xref>. Evers and Chardon (2010) have provided a spreadsheet that rendered the calculation of the risk easy and rapid through an input of few data in what is called swift QMRA (sQMRA). Using this method, the current microbiological risk could be deduced at any food processing and manufacturing facility provided that required input data are available and continuously monitored and updated <xref ref-type="bibr" rid="ridm1849165268">9</xref>. Accordingly, any modifications made in the processing steps could be assessed as either impacting the microbiological quality positively or negatively quantitatively. Thus, QMRA brings the focus to the critical steps that should be controlled to avoid any catastrophic excursion in bioburden of the produced units or pieces.</p>
      <p>A simple worked example could show the impact of changing microbial bioburden pathogenicity from minor to severe health hazard when other conditions are assumed to be the same as shown in <xref ref-type="table" rid="idm1849119196">Table 1</xref> using Risk Ranger software <xref ref-type="bibr" rid="ridm1849171748">10</xref><xref ref-type="bibr" rid="ridm1849152620">11</xref><xref ref-type="bibr" rid="ridm1849150604">12</xref>. <xref ref-type="table" rid="idm1849119196">Table 1</xref> also showed obviously that gross chaos in post-processing of food may aggravate the hazard of the food-contaminating microbial population even those with minor risk. Thus, bioburden-limiting steps in the food industry should be strictly controlled to avoid risks of microbial outbreaks. Survivability of microbial cells for food treatment process is the bioburden limiting step that has pronounced effect on the number of ill population and hence the risk factor as shown in <xref ref-type="fig" rid="idm1849071220">Figure 1</xref><xref ref-type="bibr" rid="ridm1849169372">8</xref>. </p>
      <table-wrap id="idm1849119196">
        <label>Table 1.</label>
        <caption>
          <title> Application of Risk Ranger Excel sheet in the risk assessment of microbial hazard from food consumption 456.</title>
        </caption>
        <table rules="all" frame="box">
          <tbody>
            <tr>
              <td>Severity of The Hazard</td>
              <td>Rank of The Risk</td>
              <td>Post-Processing             effectiveness<xref ref-type="table-fn" rid="idm1849118284">Ψ</xref></td>
              <td>Rank of The Risk/Total Annual Illness Per Target Population</td>
            </tr>
            <tr>
              <td>Minor</td>
              <td>33</td>
              <td>Log1= 0.000</td>
              <td>35/2.54 X10<sup>2</sup></td>
            </tr>
            <tr>
              <td>Mild</td>
              <td>39</td>
              <td>Log3=0.477</td>
              <td>38/7.61X10<sup>2</sup></td>
            </tr>
            <tr>
              <td>Moderate</td>
              <td>45</td>
              <td>Log10=1.000</td>
              <td>40/2.54 X10<sup>3</sup></td>
            </tr>
            <tr>
              <td>Severe</td>
              <td>56</td>
              <td>Log1000=3.000</td>
              <td>52/2.54 X10<sup>5</sup></td>
            </tr>
          </tbody>
        </table>
        <table-wrap-foot>
          <fn id="idm1849118284">
            <label>Ψ</label>
            <p> Increase in the bioburden of  pathogens with a minor hazard</p>
          </fn>
        </table-wrap-foot>
      </table-wrap>
      <fig id="idm1849071220">
        <label>Figure 1.</label>
        <caption>
          <title> Number of the ill population (Y-axis) vs. percent of the microbial population that survives food treatment process when other parameters were maintained constant.</title>
        </caption>
        <graphic xlink:href="images/image1.png" mime-subtype="png"/>
      </fig>
      <p>In a survey of early QMRAs, Schlundt (2000) remarked that couple of formal QMRAs had been completed as per the Codex Alimentarius rules <xref ref-type="bibr" rid="ridm1849156148">13</xref>. From the QMRAs standpoint, it was uncertain whether a basic assessment of information had occurred, and the changeability and vulnerability of the information were regularly not depicted in adequate detail. Moreover, suspicions affecting the last outcome were frequently not unmistakably introduced or basically assessed. Shockingly, indeed, even in later QMRAs similar downsides relating to the absence of a sound quality assurance (QA) framework are still regularly  experienced <xref ref-type="bibr" rid="ridm1849141108">14</xref>.</p>
      <p>Nevertheless, the application of QMRA is underestimated and/or not used with its full potential value, especially in the developing countries where lack of sufficient trends and input monitoring data are hindering barriers for correct implementation of this methodology. The mandatory implementation of this technique as a stand-alone or in combination with the other boosting tools such as Statistical Process Control (SPC) by regulatory authorities after an appropriate establishment of globally harmonized rules for the application may provide suitable starting platform.Awareness of the GxP, microbial hazard and the value of various tools used in the food microbiology the among the workers in the industry field are essential in the dissemination of correct practices to deliver safe products to the intermediate and the final customers.    </p>
    </sec>
    <sec id="idm1849114324">
      <title>Acknowledgment</title>
      <p>N/A</p>
    </sec>
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