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==1. Introduction to food and beverage laboratories==
==Sandbox begins below==
Food and beverage laboratories help develop, protect, and support the food, beverages, and nutritional supplements humans and animals consume. From creating new flavor enhancers for food to ensuring the quality and safe consumption of a wine, these labs play a vital role in most parts of the world where processed food and agricultural products are produced. These labs are found in the private, government, and academic sectors and provide many different services, including (but not limited to)<ref name="NielsenFood15">{{cite book |url=https://books.google.com/books?id=i5TdyXBiwRsC&printsec=frontcover |title=Food Analysis Laboratory Manual |author=Nielsen, S. |publisher=Springer |pages=177 |edition=2nd |year=2015 |isbn=9781441914620}}</ref>:
{{raw:wikipedia::Detection limit}}
 
* reverse engineering,
* claims testing,
* contaminate testing,
* batch variation testing,
* extractable and leachable testing,
* allergen testing,
* shelf life testing,
* non-routine quality testing, and
* packaging testing.
 
If you have ever enjoyed a candy bar, soda, or snack cake, a laboratory and food scientists were behind its production. Even if you don't care much for such processed foods, a laboratory is still involved in the quality and safety testing of raw fruits and vegetables, milk, and nuts. And when food supplies become contaminated, government testing labs are often in the thick of determining the source of the contamination as quickly as possible before more people become ill. Whether it's the unique flavor profile of a potato chip you love or the fact you can reliably acquire safe foods, remember that a laboratory is often behind it.
 
But what of the history of the food and beverage lab? What of the roles played and testing conducted in them? What do they owe to safety and quality? This chapter more closely examines these questions and more.
 
 
===1.1 Food and beverage labs, then and now===
The history of laboratory-based food and beverage tasting is a scattered one, with little being documented about foodborne illness and food safety until the nineteenth century. With a better understanding of bacteria and their relationship to disease, however, more was being said about the topic by the mid- to late-1800s.<ref name="RobertsTheFood01">{{Cite book |last=Roberts |first=Cynthia A. |date=2001 |title=The food safety information handbook |pages=25-28 |publisher=Oryx Press |place=Westport, CT |isbn=978-1-57356-305-5}}</ref> In the U.S. Northeast during the 1860s, recognition was growing concerning the threat that tainted milk originating from dairy cows being singularly fed distillery byproducts had to human health. Not only was the milk generated from such cows thin and low in nutrients, but it also was adulterated with questionable substances to give it a better appearance. This resulted in many children and adults falling ill or dying from consuming the product. The efforts of Dr. Henry Coit and others in the late 1800s to develop a certification program for milk—which included laboratory testing among other activities—eventually helped plant the seeds for a national food and beverage safety program.<ref>{{Cite book |last=Lytton |first=Timothy D. |date=2019 |title=Outbreak: foodborne illness and the struggle for food safety |chapter=Chapter 2: The Gospel of Clean Milk |publisher=The University of Chicago Press |place=Chicago ; London |pages=24-64 |isbn=978-0-226-61154-9}}</ref>
 
Roughly around the same time, during the 1880s, Britain saw more public health awareness develop in regards to digestive bacterial infections. "As deadlier infections retreated," argues social historian Anne Hardy, "food poisoning became an increasing concern of local and national health authorities, who sought both to raise public awareness of the condition as illness, and to regulate and improve food handling practices."<ref name="HardyFood99">{{Cite journal |last=Hardy |first=A. |date=1999-08-01 |title=Food, Hygiene, and the Laboratory. A Short History of Food Poisoning in Britain, circa 1850-1950 |url=https://academic.oup.com/shm/article-lookup/doi/10.1093/shm/12.2.293 |journal=Social History of Medicine |language=en |volume=12 |issue=2 |pages=293–311 |doi=10.1093/shm/12.2.293 |issn=0951-631X}}</ref> This led to further efforts from public health laboratories to promote the reporting and tracking of food poisoning cases by the 1940s.<ref name="HardyFood99" />
 
With the recognition of bacterial and other forms of contamination occurring in foodstuffs, beverages, and ingredients, as well as growing acknowledgement of the detrimental health effects of dangerous adulterations with toxic substances, additional progress was made in the realm of regulating and testing produced food and beverages. Events of interest along the way include<ref>{{Cite book |last=Stanziani, A. |date=2016 |editor-last=Atkins, P.J.; Lummel, P.; Oddy, D.J. |title=Food and the city in Europe since 1800 |url=https://books.google.com/books?hl=en&lr=&id=OPYFDAAAQBAJ&oi=fnd&pg=PA105 |chapter=Chapter 9. Municipal Laboratories and the Analysis of Foodstuffs in France Under the Third Republic: A Case Study of the Paris Municipal Laboratory, 1878-1907 |language=English |publisher=Routledge |place=London; New York |isbn=978-1-315-58261-0 |oclc=950471625}}</ref><ref name=":0">{{Cite book |last=Redman |first=Nina |date=2007 |title=Food safety: a reference handbook |url=https://www.worldcat.org/title/mediawiki/oclc/ocm83609690 |chapter=Chapter 1: Background and History |series=Contemporary world issues |edition=2nd ed |publisher=ABC-CLIO |place=Santa Barbara, Calif |isbn=978-1-59884-048-3 |oclc=ocm83609690}}</ref><ref name=":1">{{Cite book |last=Stevens, K.; Hood, S. |date=2019 |editor-last=Doyle |editor-first=Michael P. |editor2-last=Diez-Gonzalez |editor2-first=Francisco |editor3-last=Hill |editor3-first=Colin |title=Food microbiology: fundamentals and frontiers |chapter=Chapter 40. Food Safety Management Systems |edition=5th edition |publisher=ASM Press |place=Washington, DC |pages=1007-20 |isbn=978-1-55581-997-2}}</ref><ref>{{Cite book |last=Detwiler |first=Darin S. |date=2020 |title=Food safety: past, present, and predictions |chapter=Chapter 2: "Modernization" started over a century ago |publisher=Academic Press |place=London [England] ; San Diego, CA |pages=11-23 |isbn=978-0-12-818219-2}}</ref><ref name="FDABackFSMA18">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/background-fda-food-safety-modernization-act-fsma |title=Background on the FDA Food Safety Modernization Act (FSMA) |publisher=Food and Drug Administration |date=30 January 2018 |accessdate=07 December 2022}}</ref><ref name="DouglasFDA22">{{cite web |url=https://www.limswiki.org/index.php/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors |title=FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors |author=Douglas, S. |work=LIMSwiki.org |date=21 February 2022 |accessdate=07 December 2022}}</ref>:
 
*By 1880, the first of many municipal laboratories dedicated to testing food and beverage adulteration came into use in France. A focus was made on watered-down wines early on, but Frances's municipal food safety labs quickly began addressing other foods, beverages, and ingredients.
*The Pure Food and Drug Act and Beef Inspection Act were passed in 1906 in response to food quality issues in packing plants, on farms, and other areas of food production.
*In 1927, the U.S. Food, Drug, and Insecticide Administration (shortened to the U.S. Food and Drug Administration or FDA not long after) was formed to better enforce the Pure Food Act.
*By 1945, ''Clostridium perfringens'' was being identified as a common cause of foodborne illness<ref name="RobertsTheFood01" />, and today it is recognized by the [[Centers for Disease Control and Prevention]] (CDC) as one of the top five provocateurs of foodborne illness.<ref name="CDCFood20">{{cite web |url=https://www.cdc.gov/foodsafety/foodborne-germs.html |title=Foodborne Germs and Illnesses |publisher=Centers for Disease Control and Prevention |date=18 March 2020 |accessdate=07 December 2022}}</ref>
*The seeds of the Hazard Analysis and Critical Control Points (HACCP) quality control method were planted in 1959, when Pillsbury began working with NASA to ensure safe foods for astronauts. The value of Pillsbury and NASA's methodology became apparent to the food and beverage industry by 1972, and other organizations began adopting HACCP for food safety.
*The Fair Packaging and Labeling Act of 1966 brought standardized, more accurate labeling to food and beverages.
*The Food Quality Protection Act of 1996 mandated HACCP for most food processors and improved pesticide level calculations.
*FDA Food Safety Modernization Act (FSMA) was enacted in 2011, giving the FDA more enforcement authority and tools to improve the backbone of the U.S. food and water supply.
*In December 2021, the Laboratory Accreditation for Analyses of Foods (LAAF) amendment to the FSMA was approved, providing for an accreditation program for laboratories wanting to further participate in the critical role of ensuring the safety of the U.S. food supply through the "testing of food in certain circumstances."
 
This progression of scientific discovery and regulatory action has surely managed to reduce risks to U.S. food and beverage consumers, though not without complication and complexity.<ref name="LyttonAnIntro19">{{Cite book |last=Lytton |first=Timothy D. |date=2019 |chapter=An Introduction to the Food Safety System |title=Outbreak: Foodborne Illness and the Struggle for Food Safety |publisher=The University of Chicago Press |place=Chicago ; London |pages=1-23 |isbn=978-0-226-61154-9}}</ref><ref>{{Cite journal |last=Floros |first=John D. |last2=Newsome |first2=Rosetta |last3=Fisher |first3=William |last4=Barbosa-Cánovas |first4=Gustavo V. |last5=Chen |first5=Hongda |last6=Dunne |first6=C. Patrick |last7=German |first7=J. Bruce |last8=Hall |first8=Richard L. |last9=Heldman |first9=Dennis R. |last10=Karwe |first10=Mukund V. |last11=Knabel |first11=Stephen J. |date=2010-08-26 |title=Feeding the World Today and Tomorrow: The Importance of Food Science and Technology: An IFT Scientific Review |url=https://onlinelibrary.wiley.com/doi/10.1111/j.1541-4337.2010.00127.x |journal=Comprehensive Reviews in Food Science and Food Safety |language=en |volume=9 |issue=5 |pages=572–599 |doi=10.1111/j.1541-4337.2010.00127.x}}</ref> As the U.S. population has grown over the past 100 years, it has become more difficult to have a sufficient number of inspectors, for example, to examine every production facility or farm and all they do, necessitating a risk assessment approach to food and beverage safety.<ref name=":0" /><ref name=":1" /><ref>{{Cite book |date=1998 |title=Food Safety: Current Status and Future Needs |url=http://www.ncbi.nlm.nih.gov/books/NBK562616/ |series=American Academy of Microbiology Colloquia Reports |publisher=American Society for Microbiology |place=Washington (DC) |pmid=33001600}}</ref> As such, the laboratory is undoubtedly a critical component of risk-based safety assessments of food and beverage products.
 
 
===1.2 Laboratory roles and testing in the industry===
Laboratories directly and tangentially related to the food and beverage industry play a number of roles, depending on where they're situated. These roles prove to be important in the greater scheme of industry activities, in turn providing a number of benefits to society. As gleaned from prior discussion, as well as other sources, these laboratory roles can be broadly broken into three categories: research and development (R&D), pre-manufacturing and manufacturing, and post-production regulation and security. Additionally, each of these categories has its own types of laboratory testing.
 
Food and beverage laboratories tap into numerous scientific disciplines for the work they do. Among the various roles these labs serve, disciplines such as [[biochemistry]], [[biotechnology]], [[chemical engineering]], [[chemistry]], fermentation science, materials science, [[microbiology]], molecular gastronomy, and nutrition and food science are applied.<ref name="NolletHand15">{{cite book |url=https://books.google.com/books?id=KtAdCgAAQBAJ&printsec=frontcover |title=Handbook of Food Analysis (Two Volume Set) |editor=Nollet, L.M.L.; Toldrá, F. |publisher=CRC Press |edition=3rd |pages=1568 |year=2015 |isbn=9781482297843}}</ref><ref name="NielsenFood15">{{cite book |url=https://books.google.com/books?id=i5TdyXBiwRsC&printsec=frontcover |title=Food Analysis Laboratory Manual |author=Nielsen, S. |publisher=Springer |pages=177 |edition=2nd |year=2015 |isbn=9781441914620}}</ref><ref name="DouglasTheLabs22">{{cite book |url=https://www.limswiki.org/index.php/LII:The_Laboratories_of_Our_Lives:_Labs,_Labs_Everywhere!/Labs_by_industry:_Part_2 |chapter=Labs by industry: Part 2 |title=The Laboratories of Our Lives: Labs, Labs Everywhere! |author=Douglas, S.E. |publisher=LIMSwiki |edition=2nd |date=July 2022 |accessdate=07 December 2022}}</ref><ref>{{Cite book |last=Bhandari, B.; Roos, Y.H. |date=2012 |editor-last=Bhandari |editor-first=Bhesh |editor2-last=Roos |editor2-first=Yrjö H. |title=Food Materials Science and Engineering |chapter=Chapter 1: Food Materials Science and Engineering: An Overview |publisher=Wiley-Blackwell |place=Chichester, West Sussex, UK ; Ames, Iowa |pages=1–25 |isbn=978-1-4051-9922-3}}</ref> As such, a diverse skillset is typically required by the food and beverage scientist, requiring not only hard skills in microbiology, biochemistry, and fermentation, but also the flexibility and nimbleness to apply those skills to an industry with a rapidly changing consumer dynamic.<ref name="IFTDiverse20">{{cite web |url=https://www.ift.org/news-and-publications/news/2020/october/26/diverse-skill-sets-needed-for-growing-opportunities |title=Diverse skill sets needed for growing opportunities |publisher=Institute of Food Technologists |date=26 October 2020 |accessdate=07 December 2022}}</ref>
 
Although slightly dated, past surveys of food processors have largely shown a majority of testing occurring within the processor facility, with outsourcing to a third-party lab becoming a growing trend. A 2013 Advantage Business Media survey of food processors "found 32.5 percent use both in-house and outside labs; 28.9 percent use only in-house testing, and 24.1 percent send samples only to outside labs," with 14.5 percent saying they didn’t require testing.<ref name="FLynnFood13">{{cite web |url=https://www.foodsafetynews.com/2013/10/food-labs-integral-to-changing-world-of-food-safety/ |title=Food Labs Integral to Changing World of Food Safety |author=Flynn, D. |work=Food Safety News |date=07 October 2013 |accessdate=07 December 2022}}</ref> A 2017 survey by Strategic Consulting, Inc., published in ''Food Safety Magazine'', saw the number of labs sending samples only to outside labs increase, compared to the 2013 survey, with 28% of respondents saying they outsourced all samples.<ref name="FergusonOutsou17">{{cite web |url=https://www.food-safety.com/articles/5584-outsourcing-pathogen-testing-under-the-microscope |title=Outsourcing: Pathogen Testing under the Microscope |author=Ferguson, B. |work=Food Safety Magazine |date=12 December 2017 |accessdate=07 December 2022}}</ref> Similar surveys in 2020 reinforced the view that outsourcing was a growing trend, with more non-pathogen testing getting outsourced along with pathogen testing.<ref name="FergusonTrends20">{{cite web |url=https://www.food-safety.com/articles/6666-trends-in-food-safety-testing |title=Trends in Food Safety Testing |author=Ferguson, B. |work=Food Safety Magazine |date=24 June 2020 |accessdate=07 December 2022}}</ref><ref name="FergusonAnal20">{{cite web |url=https://www.food-safety.com/articles/6542-analytical-testing-in-food-safety-continues-to-grow |title=Analytical Testing in Food Safety Continues to Grow |author=Ferguson, B. |work=Food Safety Magazine |date=16 April 2020 |accessdate=07 December 2022}}</ref>
 
This increase may not be surprising given reports that third-party contract testing laboratories were increasingly being used for food quality and safety testing. A 2013 Strategic Consulting, Inc. report cited the rise in third-party labs was "in response to the growing complexity, cost, and volume of testing required by food producers and retailers."<ref name="FLThird13">{{cite web |url=https://www.foodlogistics.com/safety/news/11284235/thirdparty-testing-for-food-safety-is-on-the-rise |title=Third-Party Testing For Food Safety Is On The Rise |work=Food Logistics |date=20 December 2013 |accessdate=07 December 2022}}</ref> Another concern that may be driving outsourcing of at least microbial laboratory testing is regulatory pressure concerning pathogenic organisms in the production facility, and by extension out of the internally housed lab, though there may be a strong preference to contract with third-party labs in close proximity to the plant to better ensure desired turnaround times.<ref name="FergusonOutsou17" /> However, veterans in the food and beverage industry may view such outsourcing concerns as minimal, particularly when a facility's processes and quality mechanisms are appropriately reviewed, maintained, and enforced.<ref name="FergusonOutsou17" />
 
In regards to what kind of testing has historically been occurring in the industry, we turn back to that 2013 Advantage Business Media survey. Additional statistics from that survey revealed that 70.6 percent of respondents were testing for quality, 57.7 percent were testing for consistency, and 56.5 percent were conducting food safety tests for pathogens. Some 29.4 percent were testing for packaging accuracy claims, and 23.5 percent were testing for the presence of reported and unreported allergens.<ref name="FLynnFood13" /> More recent survey data is difficult to find, so it's not clear how these numbers compare to the realities of 2022. We can say that at least as of 2020, pathogen testing remained vital, with testing of ''Listeria'' proving a fast-growing subcategory of pathogen testing, primarily for environmental monitoring of the production facility.<ref name="FergusonTrends20" /><ref name="FergusonAnal20" /> A 2020 survey by Strategic Consulting, Inc. further indicated that the volume of microbiology testing is growing at roughly five percent, while pathogen testing volume is growing at roughly six to seven percent, adding that "outsourcing is driving the volume of tests being sent to commercial labs by as much as 10 percent."<ref name="FergusonAnal20" /> The same surveyor increased those percentages the following year.<ref name="FergusonFood21">{{cite web |url=https://www.strategic-consult.com/2021/04/food-safety-testing-to-continue-to-increase-in-2021/ |title=Food Safety Testing to Continue to Increase in 2021 |author=Ferguson, B. |work=Strategic Consulting Blog |publisher=Strategic Consulting, Inc |date=16 April 2021 |accessdate=07 December 2022}}</ref>
 
Finally, Strategic Consulting's Bob Ferguson added that [[polymerase chain reaction]] (PCR) is seeing an uptick in food and beverage testing as of 2021<ref name="FergusonFoodTwo21">{{cite web |url=https://www.strategic-consult.com/2021/06/food-safety-testing-to-continue-to-increase-in-2021-part-two/ |title=Food Safety Testing to Continue to Increase in 2021 (Part Two) |author=Ferguson, B. |work=Strategic Consulting Blog |publisher=Strategic Consulting, Inc |date=20 June 2021 |accessdate=07 December 2022}}</ref>:
 
<blockquote>As processors outsource their samples, PCR seems to be more frequently selected as the analytical method used than it was when the samples were analyzed in-plant. This possibility certainly makes sense. PCR requires expensive instrumentation and technical expertise to analyze samples properly. Every commercial lab will have a level of analyst capabilities and infrastructure that allows them to use PCR. Commercial labs will also have a high incentive to recommend the use of PCR to optimize the throughput of their instruments.</blockquote>
 
So far, we've spoken broadly of the food and beverage laboratory, the roles it can play in the industry, and the testing found in it. The following subsections more closely examine the three roles labs can play, as well as the testing found within those roles.
 
====1.2.1 R&D roles and testing====
The laboratory participating in this role is performing one or more tasks that relate to the development or improvement of a food, beverage, additive, or spice. This often leads to a commercial formulation, which has the "necessary details required to scale and produce your [food or beverage] in a consistent, efficient, and safe manner."<ref name="BSCommForm">{{cite web |url=https://www.bevsource.com/news/why-you-need-commercial-formula |title=Why You Need A Commercial Formula |publisher=BevSource |date=13 August 2022}}</ref> Even packaging solutions are targets for R&D labs in the food and beverage industry.<ref name="GudeSol19">{{cite book |chapter=Solutions Commonly Applied in Industry and Outsourced to Expert Laboratories |title=Food Contact Materials Analysis: Mass Spectrometry Techniques |author=Gude, T. |editor=Suman, M. |publisher=Royal Society of Chemistry |doi=10.1039/9781788012973-00245 |isbn=9781788017190 |year=2019}}</ref>
 
The R&D lab may appear outside the manufacturing facility proper, but not necessarily always. Some manufacturing companies may have an entire research complex dedicated to creating and improving some aspect of their products.<ref name="MonBreak16">{{cite web |url=https://ir.mondelezinternational.com/news-releases/news-release-details/mondelez-international-breaks-ground-new-research-development |title=Mondelez International Breaks Ground for New Research & Development Center in Poland |publisher=Mondelez International |date=08 June 2016 |accessdate=07 December 2022}}</ref> Other companies may take their R&D to a third-party lab dedicated to conducting development and formulation activities for manufacturers.<ref name="BSCommForm" /><ref name="GudeSol19" /> Food and beverage research activities aren't confined to manufacturers, however. Some higher education institutions, such as the Hartwick College Center for Craft Food & Beverage, provide laboratory-based research and development opportunities to students engaging in work-study programs, often in partnership with some other commercial enterprise.<ref name="HartFoodBev">{{cite web |url=https://www.hartwick.edu/about-us/center-for-craft-food-and-beverage/ |title=Hartwick College Center for Craft Food & Beverage |publisher=Hartwick College |accessdate=07 December 2022}}</ref>
 
Food and beverage R&D labs may work towards improving packaging, testing a product's shelf life (i.e., stability), conducting flavor or aroma analysis, developing and innovating foodstuffs, reformulating existing products, and researching genetic modifications to ingredients. The end user benefits by having fresher foods that are culinarily pleasing, more nutritious, and safer for consumption.
 
The following types of testing may be associated with the R&D role:
 
'''Overall food innovation and development''': International Center for Food Chain and Network Research's Schiefer and Deiters note that the food and beverage industry as a whole faces a number of significant challenges today, including economic and noneconomic changes, consumer lifestyle changes, global increases in food consumption, degradation and loss of cropland, and societal changes to attitudes concerning sustainability.<ref name="GalanakisInoov-1_21">{{Cite book |author=Schiefer, G.; Deiters, J. |editor-last=Galanakis |editor-first=Charis Michael |year=2021 |chapter=Chapter 1: Food innovation dynamics and network support |title=Innovation Strategies in the Food Industry: Tools for Implementation |url=https://books.google.com/books?id=jqZJEAAAQBAJ |language=en |publisher=Academic Press |pages=3–16 |isbn=978-0-323-91552-6}}</ref> These types of challenges require a food and beverage industry that is more agile and innovative, one that is making impactful breakthroughs to improve the quality and range of products, increasing the capacity for making products, replacing outdated products, developing more flexible or sustainable processes, and improving health and safety.<ref name="GalanakisInoov-2_21">{{Cite book |author=Bigliardi, B.; Filippelli, S. |editor-last=Galanakis |editor-first=Charis Michael |year=2021 |chapter=Chapter 2: Open innovation and incorporation between academia and the food industry |title=Innovation Strategies in the Food Industry: Tools for Implementation |url=https://books.google.com/books?id=jqZJEAAAQBAJ |language=en |publisher=Academic Press |pages=17–38 |isbn=978-0-323-91552-6}}</ref> Given the broad scope of efforts involved, the laboratory services for such impactful R&D efforts can vary widely depending on the goal. Improving the flavor of plant-based meat substitutes, for example, comes with somewhat different analytical techniques and disciplinary requirements than say improving the three-dimensional food printing of said meat substitutes.<ref name="PatelBev21">{{cite web |url=https://spectrum.ieee.org/3d-printed-meat |title=Beyond Burgers: Animal and Plant Cells Combined for 3D-Printed Steaks |author=Patel, P. |work=IEEE Spectrum |date=18 February 2021 |accessdate=07 December 2022}}</ref>
 
'''Aroma/flavor analysis and formulation''': Here the concept of "sensomic" study, an approach to describing the sensory properties of foodstuffs at a molecular level<ref name="VrzalSenso19">{{Cite journal |last=Vrzal |first=Tomáš |last2=Olšovská |first2=Jana |date=2019-10-15 |title=Sensomics - basic principles and practice |url=http://www.kvasnyprumysl.eu/index.php/kp/article/view/190 |journal=KVASNY PRUMYSL |volume=65 |issue=5 |doi=10.18832/kp2019.65.166 |issn=2570-8619}}</ref>, plays an increasingly important role.<ref name="VrzalSenso19" /><ref name="ParkerFlav14">{{Cite book |date=2014 |editor-last=Parker, J.K.; Elmore, J.S.; Methven, L. |title=Flavour development, analysis and perception in food and beverages |url=https://books.google.com/books?id=DnB7AwAAQBAJ&printsec=frontcover |series=Woodhead Publishing Series in Food Science, Technology and Nutrition |publisher=Woodhead Pub |place=Waltham, MA |pages=448 |isbn=978-1-78242-103-0}}</ref> This involves analytical techniques such as gas chromatography, liquid chromatography, and spectrophotometry, used in conjunction with chemometric data analysis to isolate and act upon volatile compounds from one or more samples.<ref name="VrzalSenso19" /><ref name="ParkerFlav14" /><ref name="NolletHand-4_15">{{cite book |url=https://books.google.com/books?id=KtAdCgAAQBAJ&printsec=frontcover |chapter=Chapter 4: Flavor |title=Handbook of Food Analysis (Two Volume Set) |author=Zellner, B.d'A.; Dugo, P.; Dugo, G. et al. |editor=Nollet, L.M.L.; Toldrá, F. |publisher=CRC Press |edition=3rd |pages=47–64 |year=2015 |isbn=9781482297843}}</ref> Aroma tends to be a more difficult concept to tackle as we've identified more than a 1,000 volatile compounds in a singular substance such as cooked meats and coffees (though typically only a small number of those compounds make a significant contribution to the overall perceived aroma<ref name="NolletHand-4_15" />), which in turn adds further complexity to overall perception of flavor.<ref name="ParkerFlav14" /> This gives laboratory researchers formulating a product for a distinct flavor profile more than a few challenges in, for example, putting together a successful mapping of chemical composition to flavor perception.<ref>{{Cite journal |last=Regueiro |first=Jorge |last2=Negreira |first2=Noelia |last3=Simal-Gándara |first3=Jesús |date=2017-07-03 |title=Challenges in relating concentrations of aromas and tastes with flavor features of foods |url=https://www.tandfonline.com/doi/full/10.1080/10408398.2015.1048775 |journal=Critical Reviews in Food Science and Nutrition |language=en |volume=57 |issue=10 |pages=2112–2127 |doi=10.1080/10408398.2015.1048775 |issn=1040-8398}}</ref>
 
'''Genetic modification for improved yields and nutrition''': The preface of Westin Carrillo's book ''Biotechnology and Food Production'' summarizes this activity well. "Biotechnology can be used in many ways to achieve higher yields; for example, by improving flowering capacity and increasing photosynthesis or the intake of nutritive elements," he says. "In the long term, genetic engineering will also help to increase production of the most valuable components of specific crops" like cassava and rice, as well as modify their amino acid composition in order to increase their otherwise deficient nutritional value.<ref name="CarrilloBio20">{{Cite book |last=Carrillo, W. |year=2020 |title=Biotechnology and Food Production |url=https://books.google.com/books?id=qePEDwAAQBAJ&printsec=frontcover |publisher=ED-Tech Press |pages=404 |isbn=9781839473432}}</ref> As this suggests, however, knowledge and skills in genetic analysis, modification, and expression are required, in turn requiring the equipment and skill for [[Sequencing|genetic sequencing]], microbial transformation, genetic use restriction technology (GURT), Northern or Western blotting, [[reverse transcription polymerase chain reaction]] (RT-PCR), etc.<ref name="CarrilloBio20" /> Admittedly, this type of R&D may fall more firmly in the hands of agriculture businesses than food and beverage businesses themselves. However, a few food and beverage business may bring their genetic modification R&D efforts in-house as an overall effort to improve a majority of its products.
 
'''Nutritional reformulation''': As various scientific understandings improve and societies shift their desires and perspectives towards processed foods, so too do the formulations used by food processors. Food scientist and author Maurice O'Sullivan describes four primary drivers for these types of reformulations<ref name="OSullivanSalt20">{{Cite book |url=https://books.google.com/books?id=vE_VDwAAQBAJ&printsec=frontcover |last=O'Sullivan |first=Maurice G. |date=2020 |chapter=Chapter 1: Understanding the requirement to reformulate: Science, health, consumer demand, regulation, and capability |title=Salt, fat, and sugar reduction: sensory approaches for nutritional reformulation of foods and beverages |publisher=Elsevier, Woodhead Publishing |place=Duxford, United Kingdom |pages=1–28 |isbn=978-0-12-819741-7}}</ref>:
 
*Society improves its scientific understanding of the major consumption-related diseases affecting human civilization, including coronary heart disease, diabetes, hypertension, and obesity.
*The population at large becomes more aware of scientists' greater understanding of consumption-related diseases.
*Food producers inevitably see reason to make changes to their foods based on both the scientific and customer-based factors that affect sales of the producers' products.
*Government further provides incentive to the producer to modify their product, through industry collaboration or outright regulation and enforcement activities.
 
O'Sullivan argues that the three most significant components of food that need to be modified are salt, fat, and sugar. Balancing these in reformulations is indeed challenging for chemical, sensory, and other reasons.<ref name="OSullivanSalt20" /> Adjusting salt levels, for example, requires chemical knowledge about salt reduction's effects on meat's shelf life and what substitutes or additives can be used to balance out the reduced salt content.<ref name="KlossSodium15">{{Cite journal |last=Kloss |first=Loreen |last2=Meyer |first2=Julia Dawn |last3=Graeve |first3=Lutz |last4=Vetter |first4=Walter |date=2015-06 |title=Sodium intake and its reduction by food reformulation in the European Union — A review |url=https://linkinghub.elsevier.com/retrieve/pii/S2352364615000024 |journal=NFS Journal |language=en |volume=1 |pages=9–19 |doi=10.1016/j.nfs.2015.03.001}}</ref> As such, reformulation requires a broad array of analytical techniques and industry knowledge, varying based upon the component sought out for change.
 
'''Stability, cycle, and challenge testing''': As hinted at in the prior subsection, salt plays an important role in the shelf life of meats and other foodstuffs.<ref name="KlossSodium15" /> However, it also can be a leading contributor to cardiovascular complications.<ref name="OSullivanSalt20" /> Finding a balance between a more nutritious product and a more shelf-stable product proves to be quite tricky. This is one of several conundrums the stability testing laboratory faces in the food and beverage industry. Multiple deteriorative catalysts can influence the shelf life of a product, from microbiological contaminants and chemical deterioration to storage conditions and the packaging itself. As such, there are multiple approaches to those catalysts, from introducing additives to improving the packaging.<ref name="SubramaniamTheStab16">{{Cite book |date=2016 |editor-last=Subramaniam |editor-first=Persis |title=The stability and shelf life of food |url=https://www.worldcat.org/title/mediawiki/oclc/956922925 |series=Woodhead Publishing Series in Food Science, Technology and Nutrition |edition=Second edition |publisher=Elsevier/WP, Woodhead Publishing |place=Amsterdam |isbn=978-0-08-100436-4 |oclc=956922925}}</ref> The analytical techniques applied in stability, cycle, and challenge testing will vary based on, to a large degree, the product matrix and its chemical composition.<ref name="SubramaniamTheStab16" /> Microbiological testing is sure to be involved, particularly in challenge testing, which simulates what could happen to a product if contaminated by a microorganism and placed in a representative storage condition.<ref>{{Cite book |last=Komitopoulou, E. |date=2011 |editor-last=Kilcast |editor-first=David |editor2-last=Subramaniam |editor2-first=Persis |title=Food and beverage stability and shelf life |url=https://www.worldcat.org/title/mediawiki/oclc/838321011 |chapter=Microbiological challenge testing of food |series=Woodhead Publishing Series in Food Science, Technology and Nutrition |publisher=WP, Woodhead Publ |place=Oxford |pages=507–526 |isbn=978-0-85709-254-0 |oclc=838321011}}</ref> Calorimetry, spectrophotometry, spectroscopy, and hyperspectral imaging can be used to properly assess color, which has been shown to be a good gauge of food quality.<ref name="SubramaniamTheStab16" /> Other test types that may be used include water content, texture, viscosity, dispersibility, glass transition, and gas chromatography.<ref name="SubramaniamTheStab16" />
 
'''Packaging analysis and extractable and leachable testing''': Materials that contact food and beverages receive special regulatory consideration in various parts of the world. This includes alloys,  bioplastics, can coatings, glass, metals, regenerated cellulose materials, paper, paperboard, plastics, printing inks, rubber, textiles, waxes, and woods.<ref>{{Cite book |date=2021 |editor-last=Baughan |editor-first=Joan Sylvain |title=Global Legislation for Food Contact Materials |url=https://www.worldcat.org/title/mediawiki/oclc/on1272898230 |series=Woodhead Publishing Series in Food Science, Technology and Nutrition |edition=Second edition |publisher=Woodhead Publishing |place=Oxford |isbn=978-0-12-821181-6 |oclc=on1272898230}}</ref> As such, attempting to break new ground in food and beverage packaging development can be a tricky matter. Concerns of chemicals and elements that can be extracted or leach into food contact materials add another layer of complexity to developing and choosing packaging materials for foods and beverages. This requires extractable and leachable testing at various phases of product development to ensure the packaging selected during formulation is safe and effective.<ref name="BaloghTesting11">{{cite journal |url=https://www.chromatographyonline.com/view/testing-critical-interface-leachables-and-extractables |title=Testing the Critical Interface: Leachables and Extractables |author=Balogh, M.P. |journal=LCGC North America |volume=29 |issue=6 |pages=492–501 |year=2011}}</ref> Extractable and leachable testing for packaging could involve a number of techniques ranging from gas and liquid chromatography to ion chromatography and inductively coupled plasma mass spectrometry.<ref name="LAExtract">{{cite web |url=https://leeder-analytical.com/extractables-and-leachables-testing/ |title=Extractables and leachables testing (E&Ls) |publisher=Leeder Analytical |accessdate=07 December 2022}}</ref>
 
====1.2.2 Pre-manufacturing and manufacturing roles and testing====
The laboratory participating in these roles is performing one or more tasks that relate to the preparative (i.e., pre-manufacturing) or [[quality control]] (i.e., manufacturing) tasks of food and beverage production. Preparative work such as caloric and nutritional analysis may happen in a variety of contexts, from inside the R&D lab to in the manufacturing facility's lab itself, if it has one. This work may also be conducted by a third-party lab, or it may even be performed using non-laboratory techniques such as food composition database analysis.<ref name="ESHAHow14">{{cite web |url=https://esha.com/wp-content/uploads/2014/12/ESHA-Obtaining-Nutritional-Analysis-eBook.pdf |format=PDF |title=How to Obtain a Nutritional Analysis of Your Food Product |publisher=ESHA Research |date=December 2014 |accessdate=07 December 2022}}</ref><ref name="NohRecent20">{{cite journal |title=Recent Techniques in Nutrient Analysis for Food Composition Database |journal=Molecules |author=Noh, M.F.M.; Gunasegavan, R.D.-N.; Khalid, N.M. et al. |volume=25 |issue=19 |at=4567 |year=2020 |doi=10.3390/molecules25194567 |pmid=33036314 |pmc=PMC7582643}}</ref> However, caloric and nutritional testing—in conjunction with meeting regulatory-driven labeling requirements—still lands firmly in the role of pre-manufacturing activity, definitively after commercial formulation and packing requirements have been finalized but before the formal manufacturing process has begun.<ref name="BSNutTest">{{cite web |url=https://www.bevsource.com/news/what-do-i-need-know-about-nutrition-testing-my-beverage-brand |title=What Do I Need To Know About Nutrition Testing for My Beverage Brand? |publisher=BevSource |date=02 December 2022}}</ref> Allergen testing works in a similar fashion, though the manufacturer ideally uses a full set of best practices for food allergen management and testing, from confirming allergens (and correct labeling) from ingredients ordered to performing final production line cleanup (e.g., when a new allergen-free commercial formulation is being made or an unintended contamination has occurred).<ref name="CA80-2020">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf |format=PDF |title=Code of Practice on Food Allergen Management for Food Business Operators, CXC 80-2020 |work=Codex Alimentarius |date=2020 |accessdate=07 December 2022}}</ref> The end user benefits from these caloric, nutritional, and allergen analysis activities not only through the provision of a more transparent window into what they are consuming; these laboratory activities also can better ensure end users' attempts at maintaining their own good health.
 
Finally, laboratory testing can also be found along the production chain in the manufacturing facility itself. This type of testing is couched as quality control testing, primarily, or as [[quality assurance]], secondarily. Some of this analysis may be integrated into the production workflow, as with x-ray inspection.<ref name="DrausQual17">{{cite web |url=https://www.eaglepi.com/blog/quality-control-or-quality-assurance-in-the-food-industry/ |title=Quality Control or Quality Assurance in the Food Industry?: X-ray Inspection Equipment Ensures Both |author=Draus, C. |work=Eagle PI |date=15 November 2017 |accessdate=07 December 2022}}</ref> Fluorescence sensing technologies are also useful for contaminant testing, though they are largely limited to laboratory use, with hopes they may become more relevant for inspection at the point of production.<ref name="HanPersp20">{{cite journal |title=Perspective on recent developments of nanomaterial based fluorescent sensors: applications in safety and quality control of food and beverages |journal=Journal of Food and Drug Analysis |author=Han, A.; Hao, S.; Yang, Y. et al. |volume=28 |issue=4 |at=2 |year=2020 |doi=10.38212/2224-6614.1270}}</ref> This move to "novel, rapid, and non-destructive" methods of testing both in the lab and in the production facility appears to be a growing trend<ref name="">{{cite book |chapter=Chapter 1.  Quality Control in Beverage Production: An Overview |title=Quality Control in the Beverage Industry |series=The Science of Beverages |volume=17 |editor=Grumezescu, A.M.; Holban, A.M. |author=Aadil, R.M.; Madni, G.M.; Roobab, U. et al. |publisher=Elsevier |pages=1-38 |isbn=9780128166826}}</ref>, loosening the concept of the "quality control laboratory" as an entity in the production facility. Regardless of analytical location, the quality control lab provides benefits to society by being a critical component of an overall [[quality management system]] that better ensures the safety of those consuming the final product.
 
The following types of testing may be associated with the pre-manufacturing and manufacturing role:
 
'''Allergen, calorie, and nutrition testing''': From label accuracy to consumer safety, this type of testing is critical to food and beverage manufacturers. Caloric and nutritional testing—in conjunction with meeting regulation-driven labeling requirements—lands firmly in the role of pre-manufacturing activity, most certainly after commercial formulation and packing requirements have been finalized but before the formal manufacturing process has begun.<ref name="BSNutTest">{{cite web |url=https://www.bevsource.com/news/what-do-i-need-know-about-nutrition-testing-my-beverage-brand |title=What Do I Need To Know About Nutrition Testing for My Beverage Brand? |publisher=BevSource |date=02 December 2022}}</ref> Allergen testing works in a similar fashion, though the manufacturer ideally uses a full set of best practices for food allergen management and testing, from confirming allergens (and correct labeling) from ingredients ordered to performing final production line cleanup (e.g., when a new allergen-free commercial formulation is being made or an unintended contamination has occurred).<ref name="CA80-2020">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf |format=PDF |title=Code of Practice on Food Allergen Management for Food Business Operators, CXC 80-2020 |work=Codex Alimentarius |date=2020 |accessdate=07 December 2022}}</ref> This role will usually require laboratory analytical techniques such as calorimetry, laser scanning confocal microscopy, immunoassays, and mass spectrometry.<ref name="DimitrovaNut19">{{cite web |url=https://www.azom.com/article.aspx?ArticleID=18555 |title=Nutrition Analysis Techniques to Determine the Nutritional Content of Food |author=Dimitrova, M. |work=AZO Materials |date=08 October 2019 |accessdate=07 December 2022}}</ref> Note, however, that non-laboratory techniques such as food composition database analysis are also used to evaluate the nutritional content of products that aren't heavily processed.<ref name="ESHAHow14">{{cite web |url=https://esha.com/wp-content/uploads/2014/12/ESHA-Obtaining-Nutritional-Analysis-eBook.pdf |format=PDF |title=How to Obtain a Nutritional Analysis of Your Food Product |publisher=ESHA Research |date=December 2014 |accessdate=07 December 2022}}</ref><ref name="NohRecent20">{{cite journal |title=Recent Techniques in Nutrient Analysis for Food Composition Database |journal=Molecules |author=Noh, M.F.M.; Gunasegavan, R.D.-N.; Khalid, N.M. et al. |volume=25 |issue=19 |at=4567 |year=2020 |doi=10.3390/molecules25194567 |pmid=33036314 |pmc=PMC7582643}}</ref>
 
'''Quality control testing''': A food or beverage product's launch success hinges on many variables; if one variable is off, it may very well be rejected by the consumer. Producers invest significantly in a product they believe in, requiring assurances along the way that it will have its best chance of success. The producer will want to ensure high-quality raw ingredients, high-quality equipment, an effective processing layout, and high customer satisfaction. A well-implemented [[quality management system]] (QMS) plays a major role in ensuring those requirements, and by extension that includes a type of testing couched as quality control testing, primarily, or as quality assurance testing, secondarily.<ref>{{Cite book |last=Aadil, R.M.; Madni, G.M.; Roobab, U. et al. |first= |last2= |first2= |last3= |first3= |date=2019 |editor-last=Grumezescu, A.; Grumezescu, A.M.; Holban, A.M. |title=Quality Control in the Beverage Industry |url=https://books.google.com/books?id=2YmpDwAAQBAJ&printsec=frontcover |chapter=Chapter 1: Quality Control in Beverage Production: An Overview |language=English |publisher=Academic Press |volume=17 |isbn=978-0-12-816682-6 |oclc=1122792300}}</ref> Many aspects of food and beverage production require high levels of quality, and as such, the type of analytical testing that takes place will vary, sometimes significantly, depending upon the associated risk. Are microbiological, physiological, or chemical risks being managed? These and other questions will determine the laboratory approach to quality, which is in turn ideally reflected in the QMS.
 
====1.2.3 Post-production regulation and security roles and testing====
The laboratory participating in these roles is performing one or more tasks that relate to the post-production examination of foods and beverages for regulatory, security, or accreditation purposes. This type of testing examines raw ingredients, consumable products, and packaging found not only in a production facility but also in locations such as shipping docks, farms, grocery stores, and more. Labs are often third parties accrediting a producer to a set of standards, ensuring regulatory compliance, conducting authenticity and adulteration testing, conducting security checks at borders, and applying contamination testing as part of an overall effort to track down the source of a foodborne illness. In the last case, the lab may not even be a traditional "food and beverage" lab but rather a [[public health laboratory]], highlighting in full the human safety elements associated with our food and water supplies. The human safety element is also seen in government labs such as the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service's (FSIS) Field Service Laboratories, which "coordinate and conduct laboratory analytical services in support of the Agency's farm-to-table strategies in the disciplines of chemistry, microbiology, and pathology for food safety in meat, poultry, and egg products."<ref name="FSISLabs">{{cite web |url=https://www.fsis.usda.gov/science-data/laboratories-procedures/fsis-laboratories |title=FSIS Laboratories |publisher=Food Safety and Inspection Service, U.S. Department of Agriculture |date=26 April 2019 |accessdate=07 December 2022}}</ref> In addition to ensuring a safer food supply, society also benefits from these and similar labs by better holding producers legally accountable for their production methods and obligations.
 
The following types of testing may be associated with the post-production regulation and security role:
 
'''Authenticity and adulteration testing''': A variety of local, regional, national, and international entities (e.g., Operation OPSON, E.U. Food Fraud Network, and U.S. Customs and Border Protection) are responsible for detecting and preventing violations of food supply chain laws and regulations across national and international borders, while also collecting evidence for investigation and prosecution. "To support these regulatory and commercial initiatives," says Gerard Downey of the Teagasc Food Research Centre, "research scientists have devoted considerable resources to the development of analytical techniques to identify foods or food ingredients that are in breach of labeling requirement and may consequently be adulterated." Among these techniques are DNA fingerprinting; visible, ultraviolet, infrared, fluorescence emission, and nuclear magnetic resonance spectroscopy; mass spectrometry; isotopic analysis; [[chromatography]]; [[polymerase chain reaction]]; differential scanning calorimetry; chemometric; and "electric nose and tongue" techniques.<ref>{{Cite book |last=Downey |first=Gerard |date=2016 |title=Advances in Food Authenticity Testing. |url=https://books.google.com/books?id=Q-8QCgAAQBAJ&printsec=frontcover |language=English |publisher=Woodhead Publishing. |place=S.l. |pages=798 |isbn=978-0-08-100233-9 |oclc=1096681184}}</ref>
 
'''Accreditation-led testing''': At the end of 2021, the U.S. Food and Drug Administration amended the Food Safety Modernization ACT (FSMA) to include the Laboratory Accreditation for Analyses of Foods (LAAF) rule, which mandates laboratory "testing of food in certain circumstances" be performed by LAAF-accredited laboratories. This accreditation is optional and designed for those accreditation bodies and laboratories that have been or are seeking to be be recognized by the FDA as able to LAAF-accredit or be LAAF-accredited for the testing needs of the program. LAAF's "certain circumstances" include not only regulatory-based testing of specific sprouts, eggs, and water, but also certain foods being considered for import into the country.<ref name="DouglasFDA22">{{cite web |url=https://www.limswiki.org/index.php/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors |title=FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors |author=Douglas, S. |work=LIMSwiki.org |date=21 February 2022 |accessdate=07 December 2022}}</ref> LAAF represents one of several legal and regulatory forces driving accreditation of food and beverage laboratories to a higher standard. It also means greater potential for more testing opportunities for the third-party food and beverage lab wishing to expand into enforcement and security roles. The type of testing they conduct will already mirror those of other roles mentioned prior, but with greater emphasis on meeting stricter testing requirements.
 
====1.2.4 Tangential laboratory work====
The following tangential laboratory roles aren't necessarily found directly in the food and beverage facility. However, some level of laboratory work is required in these roles, which intersect with the food and beverage industry in some capacity.
 
'''Processing equipment design, monitoring, and sanitation''': "Sanitation provides the hygienic conditions required to produce safe food," say Ho and Sandoval in chapter seven of ''Food Safety Engineering''.<ref name="HoSanit20">{{Citation |last=Ho |first=Kai-Lai Grace |last2=Sandoval |first2=Alex |date=2020 |editor-last=Demirci |editor-first=Ali |editor2-last=Feng |editor2-first=Hao |editor3-last=Krishnamurthy |editor3-first=Kathiravan |title=Sanitation Standard Operating Procedures (SSOPs) |url=http://link.springer.com/10.1007/978-3-030-42660-6_7 |work=Food Safety Engineering |language=en |publisher=Springer International Publishing |place=Cham |pages=175–190 |doi=10.1007/978-3-030-42660-6_7 |isbn=978-3-030-42659-0}}</ref> "Improper sanitation of equipment can potentially introduce hazardous contamination to food and enhance pathogen harborage in the food-processing environment."<ref name="HoSanit20" /> They note the value of sanitation standard operating procedures (SSOPs) to the production facility, which dictate sanitation methods and frequencies, monitoring methods, and record keeping methods.<ref name="HoSanit20" /> These SSOPs are not only driven by good manufacturing practice (GMP) but also appropriate and effective laboratory testing. That foundation of laboratory testing has occurred historically with the experience of food and beverage producers and those engineering and standardizing hygienic solutions for the industry. Combined, these industry and laboratory experiences have driven regulations and standards on hygienic design throughout the world. Broadly speaking, this has culminated in a set of "fundamental hygienic requirements for product contact surfaces and food equipment," ranging from physical and chemical properties such as being nontoxic, corrosion-resistant, and non-absorbent, to mechanical properties such as being durable and smooth, and operational properties such as being cleanable and low-maintenance.<ref>{{Citation |last=Schmidt |first=Ronald H. |last2=Piotter |first2=Helen M. |date=2020 |editor-last=Demirci |editor-first=Ali |editor2-last=Feng |editor2-first=Hao |editor3-last=Krishnamurthy |editor3-first=Kathiravan |title=The Hygienic/Sanitary Design of Food and Beverage Processing Equipment |url=http://link.springer.com/10.1007/978-3-030-42660-6_12 |work=Food Safety Engineering |language=en |publisher=Springer International Publishing |place=Cham |pages=267–332 |doi=10.1007/978-3-030-42660-6_12 |isbn=978-3-030-42659-0}}</ref><ref name="EUSelect20">{{cite web |url=https://engineering-update.co.uk/2020/04/03/selecting-materials-for-standard-parts-in-the-food-and-beverage-industry-a-buyers-guide/ |title=Selecting materials for standard parts in the food and beverage industry: a buyers’ guide |author=n.a. |work=Engineering Update |date=03 April 2020 |accessdate=07 December 2022}}</ref> In turn, these properties require laboratory and engineering knowledge about metals, alloys, plastics, and many other materials.<ref name="EUSelect20" /> Here we find multi-disciplinary knowledge in materials science, microbiology, chemistry, physics, and more, implying a corresponding necessity for knowledge on a wide variety of testing methods.
 
'''Public health and clinical diagnostics for foodborne illness''': While [[Public health laboratory|public health]] and [[Clinical laboratory|clinical diagnostic laboratories]] are indeed of a different ilk, they are undoubtedly intertwined with the food and beverage industry. With millions of people getting sick and thousands hospitalized and dying from foodborne diseases each year in the U.S. alone<ref name="CDCBurdenFood18">{{cite web |url=https://www.cdc.gov/foodborneburden/estimates-overview.html |title=Burden of Foodborne Illness: Overview |publisher=Centers for Disease Control and Prevention |work=Estimates of Foodborne Illness in the United States |date=05 November 2018 |accessdate=07 December 2022}}</ref>, this fact becomes clearer. When the food and beverage industry's SSOP- and QMS-related activities go awry—knowingly or unknowingly—or if the consumer does not follow proper precautions with the foods and beverages they consume, [[Public health laboratory|public health]] and [[Clinical laboratory|clinical laboratories]] may get involved in tracking the source of the pathogen or treating the foodborne illness, respectively. As previous discussion has noted<ref name="DouglasWhatIs22">{{cite web |url=https://www.limswiki.org/index.php/LIMS_FAQ:What_is_the_importance_of_a_food_and_beverage_testing_laboratory_to_society%3F |title=What is the importance of a food and beverage testing laboratory to society? |author=Douglas, S.E. |publisher=LIMSwiki |date=16 August 2022 |accessdate=07 December 2022}}</ref>, the interest of public health is at the foundation of the historical and regulatory development of the modern food and beverage industry. In the U.S., the presence of these labs is characterized by efforts such as FoodNet, a [[Centers for Disease Control and Prevention]] (CDC) program that conducts "active surveillance; surveys of laboratories, physicians, and the general population; and population-based epidemiologic studies" for roughly 15 percent of the U.S. population.<ref name="CDCAboutFN21">{{cite web |url=https://www.cdc.gov/foodnet/about.html |title=About FoodNet |publisher=Centers for Disease Control and Prevention |date=23 September 2021 |accessdate=07 December 2022}}</ref> As a public health tool, FoodNet helps track rates of illness from foodborne pathogens. Through its Diagnostic Laboratory Practices Tool, the public health tool extends into the clinical diagnostics realm, recruiting nearly 700 of those labs to report on their testing practices in regards to select enteric pathogens. From there, one can glean the test methods and specimen submissions being conducted.<ref name="CDCLabSurv">{{cite web |url=https://wwwn.cdc.gov/FoodNetFast/LabSurvey |title=Diagnostic Laboratory Practices |work=FoodNet Fast |publisher=Centers for Disease Control and Prevention |date=23 September 2021 |accessdate=07 December 2022}}</ref>
 
 
===1.3 Safety and quality in the food and beverage industry===
According to 2011 estimates by the CDC, "48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States."<ref name="CDCBurdenFood18">{{cite web |url=https://www.cdc.gov/foodborneburden/estimates-overview.html |title=Burden of Foodborne Illness: Overview |publisher=Centers for Disease Control and Prevention |work=Estimates of Foodborne Illness in the United States |date=05 November 2018 |accessdate=07 December 2022}}</ref> As of December 2022, the CDC has yet to issue revised estimates of these numbers. However, one can wonder if those numbers are higher post-COVID. On a more global scale, the World Health Organization (WHO) estimates that one in ten people worldwide fall ill to consuming contaminated food.<ref name="WHOBurdenFood">{{cite web |url=https://www.who.int/activities/estimating-the-burden-of-foodborne-diseases |title=Estimating the burden of foodborne diseases |publisher=World Health Organization |accessdate=07 December 2022}}</ref> These and other statistics highlight the vital nature of improving safety and quality in the world's food supplies.
 
The demand for this safety and quality work is most obvious when viewed from the governmental level. For example, the U.S. Department of Agriculture (USDA) estimated in 2017 that some "7,500 food safety inspection personnel go to work in more than 6,000 regulated food facilities and 122 ports of entry," and "[a]nother 2,000 food safety professionals go to work in three public health laboratories, 10 district offices, and our headquarters office. These employees run test results, dispatch outbreak investigators, and unpack data to reveal telling trends and inform proactive, prevention-based policies that will lead to safer food and fewer illnesses."<ref name="AlmanzaTheUSFood17">{{cite web |url=https://www.usda.gov/media/blog/2016/07/05/us-food-safety-system-has-come-long-way-50-years |title=The U.S. Food Safety System Has Come A Long Way in 50 Years |author=Almanza, A.V. |publisher=U.S. Department of Agriculture |date=21 February 2017 |accessdate=14 August 2022}}</ref> In another example, the U.S. Centers for Disease Control and Prevention (CDC) and its FoodNet surveillance program conducts "active surveillance; surveys of laboratories, physicians, and the general population; and population-based epidemiologic studies" for roughly 15 percent of the U.S. population.<ref name="CDCAboutFN21">{{cite web |url=https://www.cdc.gov/foodnet/about.html |title=About FoodNet |publisher=Centers for Disease Control and Prevention |date=23 September 2021 |accessdate=14 August 2022}}</ref> Additionally, entities like the USDA and the U.S. Food and Drug Administration (FDA) are significant forces behind the development of regulations that affect how and when other entities—governmental and non-governmental—conduct their food and beverage testing and production activities.
 
We also must look outside the government level, to presumably the bulk of food and beverage labs located in the private sector. We have to use "presumably" because, as Robin Stombler of ''Food Safety Tech'' noted in April 2016, no one really knows how many food laboratories exist in, for example, the U.S.<ref name="StomblerCount16">{{cite web |url=https://foodsafetytech.com/feature_article/counting-food-laboratories/ |title=Counting Food Laboratories |author=Stombler, R. |work=Food Safety Tech |date=04 April 2016 |accessdate=07 December 2022}}</ref> As Stombler noted, this causes several problems<ref name="StomblerCount16" />:
 
<blockquote>For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.</blockquote>
 
The FDA finally made some minor progress in this department, announcing in December 2021 that food and beverage labs conducting a specific range of activities would need to become accredited, and a list of accredited labs would be maintained.<ref name="FSNLab21">{{cite web |url=https://www.foodsafetynews.com/2021/12/laboratory-accreditation-required-by-fsma-finally-becoming-a-reality/ |title=Laboratory accreditation required by FSMA finally becoming a reality |author=News Desk |work=Food Safety News |date=10 December 2021 |accessdate=07 December 2022}}</ref><ref name="FSMFDARel22">{{cite web |url=https://www.food-safety.com/articles/7923-fda-releases-new-dashboard-for-laboratory-accreditation-for-analyses-of-foods-program |title=FDA Releases New Dashboard for Laboratory Accreditation for Analyses of Foods Program |work=Food Safety Magazine |date=05 August 2022 |accessdate=07 December 2022}}</ref> The accreditation described under the FDA's Laboratory Accreditation for Analyses of Foods (LAAF) rule is voluntary, but labs wanting to participate will need to get accredited.<ref name="FSNLab21" /> For now, only specific types of testing require accreditation, including sprouts, mass-produced eggs, bottled drinking water, certain imports, and certain items affected by recalls and other regulatory action.<ref name="DouglasFDA22" /> This may expand in the future, and it may force more food and beverage labs to become accredited and recognized.
 
That said, these third-party food safety and quality labs exist not just because of regulatory controls, but also because private incentives towards maintaining reputation and a standard of quality in the industry. Virginia Tech's John Bovay emphasizes this in an August 2022 research paper:
 
<blockquote>Producers and sellers often implement private or collective standards for food safety as an investment in their own reputations. Producers who have invested in such standards can benefit from additional regulations that improve safety because these regulations can further bolster the reputation of the industry and also raise costs for rival firms. Thus, food-safety regulations may have effects on competition and certainly can have differential welfare effects.</blockquote>
 
 
==References==
{{Reflist|colwidth=30em}}

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The limit of detection (LOD or LoD) is the lowest signal, or the lowest corresponding quantity to be determined (or extracted) from the signal, that can be observed with a sufficient degree of confidence or statistical significance. However, the exact threshold (level of decision) used to decide when a signal significantly emerges above the continuously fluctuating background noise remains arbitrary and is a matter of policy and often of debate among scientists, statisticians and regulators depending on the stakes in different fields.

Significance in analytical chemistry

In analytical chemistry, the detection limit, lower limit of detection, also termed LOD for limit of detection or analytical sensitivity (not to be confused with statistical sensitivity), is the lowest quantity of a substance that can be distinguished from the absence of that substance (a blank value) with a stated confidence level (generally 99%).[1][2][3] The detection limit is estimated from the mean of the blank, the standard deviation of the blank, the slope (analytical sensitivity) of the calibration plot and a defined confidence factor (e.g. 3.2 being the most accepted value for this arbitrary value).[4] Another consideration that affects the detection limit is the adequacy and the accuracy of the model used to predict concentration from the raw analytical signal.[5]

As a typical example, from a calibration plot following a linear equation taken here as the simplest possible model:

where, corresponds to the signal measured (e.g. voltage, luminescence, energy, etc.), "Template:Mvar" the value in which the straight line cuts the ordinates axis, "Template:Mvar" the sensitivity of the system (i.e., the slope of the line, or the function relating the measured signal to the quantity to be determined) and "Template:Mvar" the value of the quantity (e.g. temperature, concentration, pH, etc.) to be determined from the signal ,[6] the LOD for "Template:Mvar" is calculated as the "Template:Mvar" value in which equals to the average value of blanks "Template:Mvar" plus "Template:Mvar" times its standard deviation "Template:Mvar" (or, if zero, the standard deviation corresponding to the lowest value measured) where "Template:Mvar" is the chosen confidence value (e.g. for a confidence of 95% it can be considered Template:Mvar = 3.2, determined from the limit of blank).[4]

Thus, in this didactic example:

There are a number of concepts derived from the detection limit that are commonly used. These include the instrument detection limit (IDL), the method detection limit (MDL), the practical quantitation limit (PQL), and the limit of quantitation (LOQ). Even when the same terminology is used, there can be differences in the LOD according to nuances of what definition is used and what type of noise contributes to the measurement and calibration.[7]

The figure below illustrates the relationship between the blank, the limit of detection (LOD), and the limit of quantitation (LOQ) by showing the probability density function for normally distributed measurements at the blank, at the LOD defined as 3 × standard deviation of the blank, and at the LOQ defined as 10 × standard deviation of the blank. (The identical spread along Abscissa of these two functions is problematic.) For a signal at the LOD, the alpha error (probability of false positive) is small (1%). However, the beta error (probability of a false negative) is 50% for a sample that has a concentration at the LOD (red line). This means a sample could contain an impurity at the LOD, but there is a 50% chance that a measurement would give a result less than the LOD. At the LOQ (blue line), there is minimal chance of a false negative.

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Instrument detection limit

Most analytical instruments produce a signal even when a blank (matrix without analyte) is analyzed. This signal is referred to as the noise level. The instrument detection limit (IDL) is the analyte concentration that is required to produce a signal greater than three times the standard deviation of the noise level. This may be practically measured by analyzing 8 or more standards at the estimated IDL then calculating the standard deviation from the measured concentrations of those standards.

The detection limit (according to IUPAC) is the smallest concentration, or the smallest absolute amount, of analyte that has a signal statistically significantly larger than the signal arising from the repeated measurements of a reagent blank.

Mathematically, the analyte's signal at the detection limit () is given by:

where, is the mean value of the signal for a reagent blank measured multiple times, and is the known standard deviation for the reagent blank's signal.

Other approaches for defining the detection limit have also been developed. In atomic absorption spectrometry usually the detection limit is determined for a certain element by analyzing a diluted solution of this element and recording the corresponding absorbance at a given wavelength. The measurement is repeated 10 times. The 3σ of the recorded absorbance signal can be considered as the detection limit for the specific element under the experimental conditions: selected wavelength, type of flame or graphite oven, chemical matrix, presence of interfering substances, instrument... .

Method detection limit

Often there is more to the analytical method than just performing a reaction or submitting the analyte to direct analysis. Many analytical methods developed in the laboratory, especially these involving the use of a delicate scientific instrument, require a sample preparation, or a pretreatment of the samples prior to being analysed. For example, it might be necessary to heat a sample that is to be analyzed for a particular metal with the addition of acid first (digestion process). The sample may also be diluted or concentrated prior to analysis by means of a given instrument. Additional steps in an analysis method add additional opportunities for errors. Since detection limits are defined in terms of errors, this will naturally increase the measured detection limit. This "global" detection limit (including all the steps of the analysis method) is called the method detection limit (MDL). The practical way for determining the MDL is to analyze seven samples of concentration near the expected limit of detection. The standard deviation is then determined. The one-sided Student's t-distribution is determined and multiplied versus the determined standard deviation. For seven samples (with six degrees of freedom) the t value for a 99% confidence level is 3.14. Rather than performing the complete analysis of seven identical samples, if the Instrument Detection Limit is known, the MDL may be estimated by multiplying the Instrument Detection Limit, or Lower Level of Detection, by the dilution prior to analyzing the sample solution with the instrument. This estimation, however, ignores any uncertainty that arises from performing the sample preparation and will therefore probably underestimate the true MDL.

Limit of each model

The issue of limit of detection, or limit of quantification, is encountered in all scientific disciplines. This explains the variety of definitions and the diversity of juridiction specific solutions developed to address preferences. In the simplest cases as in nuclear and chemical measurements, definitions and approaches have probably received the clearer and the simplest solutions. In biochemical tests and in biological experiments depending on many more intricate factors, the situation involving false positive and false negative responses is more delicate to handle. In many other disciplines such as geochemistry, seismology, astronomy, dendrochronology, climatology, life sciences in general, and in many other fields impossible to enumerate extensively, the problem is wider and deals with signal extraction out of a background of noise. It involves complex statistical analysis procedures and therefore it also depends on the models used,[5] the hypotheses and the simplifications or approximations to be made to handle and manage uncertainties. When the data resolution is poor and different signals overlap, different deconvolution procedures are applied to extract parameters. The use of different phenomenological, mathematical and statistical models may also complicate the exact mathematical definition of limit of detection and how it is calculated. This explains why it is not easy to come to a general consensus, if any, about the precise mathematical definition of the expression of limit of detection. However, one thing is clear: it always requires a sufficient number of data (or accumulated data) and a rigorous statistical analysis to render better signification statistically.

Limit of quantification

The limit of quantification (LoQ, or LOQ) is the lowest value of a signal (or concentration, activity, response...) that can be quantified with acceptable precision and accuracy.

The LoQ is the limit at which the difference between two distinct signals / values can be discerned with a reasonable certainty, i.e., when the signal is statistically different from the background. The LoQ may be drastically different between laboratories, so another detection limit is commonly used that is referred to as the Practical Quantification Limit (PQL).

See also

References

  1. IUPAC, Compendium of Chemical Terminology, 2nd ed. (the "Gold Book") (1997). Online corrected version:  (2006–) "detection limit".
  2. "Guidelines for Data Acquisition and Data Quality Evaluation in Environmental Chemistry". Analytical Chemistry 52 (14): 2242–49. 1980. doi:10.1021/ac50064a004. 
  3. Saah AJ, Hoover DR (1998). "[Sensitivity and specificity revisited: significance of the terms in analytic and diagnostic language."]. Ann Dermatol Venereol 125 (4): 291–4. PMID 9747274. https://pubmed.ncbi.nlm.nih.gov/9747274. 
  4. 4.0 4.1 "Limit of blank, limit of detection and limit of quantitation". The Clinical Biochemist. Reviews 29 Suppl 1 (1): S49–S52. August 2008. PMC 2556583. PMID 18852857. https://www.ncbi.nlm.nih.gov/pmc/articles/2556583. 
  5. 5.0 5.1 "R: "Detection" limit for each model" (in English). search.r-project.org. https://search.r-project.org/CRAN/refmans/bioOED/html/calculate_limit.html. 
  6. "Signal enhancement on gold nanoparticle-based lateral flow tests using cellulose nanofibers". Biosensors & Bioelectronics 141: 111407. September 2019. doi:10.1016/j.bios.2019.111407. PMID 31207571. http://ddd.uab.cat/record/218082. 
  7. Long, Gary L.; Winefordner, J. D., "Limit of detection: a closer look at the IUPAC definition", Anal. Chem. 55 (7): 712A–724A, doi:10.1021/ac00258a724 

Further reading

  • "Limits for qualitative detection and quantitative determination. Application to radiochemistry". Analytical Chemistry 40 (3): 586–593. 1968. doi:10.1021/ac60259a007. ISSN 0003-2700. 

External links

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