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| ==Sandbox begins below== | | ==Sandbox begins below== |
| Societies around the world have grown to expect and depend on high-quality products that prove safe to their health. ...
| | ==1. Introduction to materials and materials testing laboratories== |
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| This chapter will briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer products, but also that in many cases dictate what and how quality activities are conducted towards ensuring product safety around the world inside and outside the manufacturing-based laboratory. | | What is a material? This question is surprisingly more complex for the layperson than may be expected. The definition of "material" has varied significantly over the years, dependent on the course of study, laboratory, author, etc. A 1974 definition by Richardson and Peterson that has seen some use in academic study defines a material as "any nonliving matter of academic, engineering, or commercial importance."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Chapter 1: Introduction to Analytical Methods |series=Materials science series |publisher=Academic Press |place=New York |page=2 |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> But recently biomaterials like biopolymers (as replacements for plastics)<ref>{{Cite journal |last=Das |first=Abinash |last2=Ringu |first2=Togam |last3=Ghosh |first3=Sampad |last4=Pramanik |first4=Nabakumar |date=2023-07 |title=A comprehensive review on recent advances in preparation, physicochemical characterization, and bioengineering applications of biopolymers |url=https://link.springer.com/10.1007/s00289-022-04443-4 |journal=Polymer Bulletin |language=en |volume=80 |issue=7 |pages=7247–7312 |doi=10.1007/s00289-022-04443-4 |issn=0170-0839 |pmc=PMC9409625 |pmid=36043186}}</ref> and even natural<ref>{{Cite journal |last=Kurniawan |first=Nicholas A. |last2=Bouten |first2=Carlijn V.C. |date=2018-04 |title=Mechanobiology of the cell–matrix interplay: Catching a glimpse of complexity via minimalistic models |url=https://linkinghub.elsevier.com/retrieve/pii/S2352431617301864 |journal=Extreme Mechanics Letters |language=en |volume=20 |pages=59–64 |doi=10.1016/j.eml.2018.01.004}}</ref> and engineered biological tissues<ref>{{Cite journal |last=Kim |first=Hyun S. |last2=Kumbar |first2=Sangamesh G. |last3=Nukavarapu |first3=Syam P. |date=2021-03 |title=Biomaterial-directed cell behavior for tissue engineering |url=https://linkinghub.elsevier.com/retrieve/pii/S246845112030057X |journal=Current Opinion in Biomedical Engineering |language=en |volume=17 |pages=100260 |doi=10.1016/j.cobme.2020.100260 |pmc=PMC7839921 |pmid=33521410}}</ref> may be referenced as "materials." (And to Richardson and Peterson's credit, they do add in the preface of their 1974 work that "[a]lthough the volumes are directed toward the physical sciences, they can also be of value for the biological scientist with materials problems."<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Preface |series=Materials science series |publisher=Academic Press |place=New York |page=xiii |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref> A modern example would be biodegradable materials research for tissue and medical implant engineering.<ref>{{Cite journal |last=Modrák |first=Marcel |last2=Trebuňová |first2=Marianna |last3=Balogová |first3=Alena Findrik |last4=Hudák |first4=Radovan |last5=Živčák |first5=Jozef |date=2023-03-16 |title=Biodegradable Materials for Tissue Engineering: Development, Classification and Current Applications |url=https://www.mdpi.com/2079-4983/14/3/159 |journal=Journal of Functional Biomaterials |language=en |volume=14 |issue=3 |pages=159 |doi=10.3390/jfb14030159 |issn=2079-4983 |pmc=PMC10051288 |pmid=36976083}}</ref>) Yet today more questions arise. what of matter that doesn't have "academic, engineering, or commercial importance"; can it now be called a "material" in 2023? What if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists? Indeed, the definition of "material" today is no easy task. This isn't made easier when even modern textbooks introduce the topic of materials science without aptly defining what a material actually is<ref>{{Cite book |last=Callister |first=William D. |last2=Rethwisch |first2=David G. |date= |year=2021 |title=Fundamentals of materials science and engineering: An integrated approach |url=https://books.google.com/books?id=NC09EAAAQBAJ&newbks=1&newbks_redir=0&printsec=frontcover |chapter=Chapter 1. Introduction |publisher=Wiley |place=Hoboken |pages=2–18 |isbn=978-1-119-74773-4}}</ref>, let alone what materials science is.<ref>{{Cite book |last=Sutton |first=Adrian P. |date=2021 |title=Concepts of materials science |edition=First edition |publisher=Oxford University Oress |place=Oxford [England] ; New York, NY |isbn=978-0-19-284683-9}}</ref> Perhaps the writers of said textbooks assume that the definitions of "material" and "materials science" have a "well duh" response. |
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| | To complicate things further, a material can be defined based upon the context of use. Take for example the ISO 10303-45 standard by the [[International Organization for Standardization]] (ISO), which addresses the representation and exchange of material and product manufacturing information in a standardized way, specifically describing how material and other engineering properties can be described in the model/framework.<ref name="ISO10303-45">{{cite web |url=https://www.iso.org/standard/78581.html |title=ISO 10303-45:2019 ''Industrial automation systems and integration — Product data representation and exchange — Part 45: Integrated generic resource: Material and other engineering properties'' |publisher=International Organization for Standardization |date=November 2019 |accessdate=20 September 2023}}</ref><ref name=":0">{{Cite journal |last=Swindells |first=Norman |date=2009 |title=The Representation and Exchange of Material and Other Engineering Properties |url=http://datascience.codata.org/articles/abstract/10.2481/dsj.008-007/ |journal=Data Science Journal |language=en |volume=8 |pages=190–200 |doi=10.2481/dsj.008-007 |issn=1683-1470}}</ref> The context here is "standardized data transfer of material- and product-related data," which in turn involves [[Ontology (information science)|ontologies]] that limit the complexity of materials science discourse and help better organize materials and product data into information and knowledge. As such, the ISO 10303 set of standards must define "material," and 10303-45 complicates matters further in this regard (though it will be helpful for this guide in the end). |
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| ===2.1 Globally recognized manufacturing standards===
| | In reviewing ISO 10303-45 in 2009, Swindells notes the following about the standard<ref name=":0" />: |
| Manufacturing industries of all types depend on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked safety and quality standards benefits the manufacturer in a number of ways<ref>{{Cite journal |last=Mor |first=Rahul S. |last2=Bhardwaj |first2=Arvind |last3=Singh |first3=Sarbjit |last4=Sachdeva |first4=Anish |date=2019-10-21 |title=Productivity gains through standardization-of-work in a manufacturing company |url=https://www.emerald.com/insight/content/doi/10.1108/JMTM-07-2017-0151/full/html |journal=Journal of Manufacturing Technology Management |language=en |volume=30 |issue=6 |pages=899–919 |doi=10.1108/JMTM-07-2017-0151 |issn=1741-038X}}</ref><ref>{{Cite journal |last=Allen |first=Robert H |last2=Sriram |first2=Ram D |date=2000-06 |title=The Role of Standards in Innovation |url=https://linkinghub.elsevier.com/retrieve/pii/S0040162599001043 |journal=Technological Forecasting and Social Change |language=en |volume=64 |issue=2-3 |pages=171–181 |doi=10.1016/S0040-1625(99)00104-3}}</ref><ref name="PavlovićWhat17">{{cite web |url=https://www.ideagen.com/thought-leadership/blog/what-is-brc-global-food-safety-standard-explained |title=What is BRC? Global food safety standard explained |author=Pavlović, A. |work=Ideagen Blog |publisher=Ideagen Limited |date=26 June 2017 |accessdate=21 April 2023}}</ref><ref name="PJBRCGS20">{{cite web |url=https://www.pjfsc.com/Downloads/BRC-Overview.pdf |format=PDF |title=BRCGS - British Retail Consortium Global Standard |publisher=Perry Johnson Food Safety Consulting, Inc |date=April 2020 |accessdate=21 April 2023}}</ref>:
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| *It increases customer confidence through the organization's audited certification to the standard, taking the place of customers' own auditing methods to ensure quality and authenticity, in turn reducing time and costs.
| | <blockquote>The first edition of ISO 10303-45 was derived from experience of the testing of, so-called, "materials" properties, and the terminology used in the standard reflects this experience. However, the information modelling of an engineering material, such as alloyed steel or high density polyethylene, is no different from the information modelling of a "product." The "material" properties are therefore one of the characteristics of a product, just as its shape and other characteristics are. Therefore all "materials" are products, and the information model in ISO 10303-45 can be used for any property of any product.</blockquote> |
| *It drives organizations to better monitor their activities for non-conformities, identify root causes, and develop preventative controls, while clearly reporting such efforts to customers, further reducing the need for customer audits.
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| *It better ensures a rigorous and comprehensive approach to product safety, quality, integrity, and legality, in many cases meeting or exceeding local, state, federal, and/or international legislative requirements.
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| *It drives organizations to better vet their suppliers and service providers for meeting required product safety management practices.
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| *It enables organizations to better demonstrate auditable compliance with modern product safety management practices.
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| *It allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.
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| As such, manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to a wide variety of manufacturing industries.
| | Put in other words, for the purposes of defining "material" for a broader, more standardized ontology, materials and products can be viewed as interchangeable. Mies puts this another way, stating that based on ISO 10303-45, a material can be defined as "a manufactured object with associated properties in the context of its use environment."<ref>{{Cite book |last=Mies, D. |date=2002 |editor-last=Kutz |editor-first=Myer |title=Handbook of materials selection |url=https://books.google.com/books?id=gWg-rchM700C&pg=PA499 |chapter=Chapter 17. Managing Materials Data |publisher=J. Wiley |place=New York |page=499 |isbn=978-0-471-35924-1}}</ref> But this representation only causes more confusion as we ask "does a material have to be manufactured?" After all, we have the term "raw material," which the Oxford English Dictionary defines as "the basic material from which a product is manufactured or made; unprocessed material."<ref name="OEDRawMat">{{cite web |url=https://www.oed.com/search/dictionary/?scope=Entries&q=raw+material |title=raw material |work=Oxford English Dictionary |accessdate=20 September 2023}}</ref> Additionally, chemical elements are defined as "the fundamental materials of which all matter is composed."<ref>{{Cite web |last=Lagowski, J.J.; Mason, B.H.; Tayler, R.J. |date=16 August 2023 |title=chemical element |work=Encyclopedia Britannica |url=https://www.britannica.com/science/chemical-element |accessdate=20 September 2023}}</ref> Taking into account the works of Richardson and Peterson, Mies, and Swindells, as well as ISO 10303-45, the concepts of "raw materials" and "chemical elements," and modern trends towards the inclusion of biomaterials (though discussion of biomaterials will be limited here) in materials science, we can land on the following definition for the purposes of this guide: |
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| ====2.1.1 Food and beverage====
| | :A material is discrete matter that is elementally raw (e.g., native metallic and non-metallic elements), fundamentally processed (e.g., calcium oxide), or fully manufactured (by human, automation, or both; e.g., a fastener) that has an inherent set of properties that a human or automation-driven solution (e.g., an [[artificial intelligence]] [AI] algorithm) has identified for a potential or realized use environment. |
| [[File:FDA Food Safety & Applied Nutrition Lab (3830) (7944692320).jpg|right|340px]]Food and beverage researchers and manufacturers adopt standards from one or more organizations around the world, not only to benefit their operations but also meet or exceed regulatory requirements for their industry. What follows are some of the more critical standards and guidelines that apply to the food, beverage, and feed industries.
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| '''2.1.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)''' | | First, this definition more clearly defines the types of matter that can be included, recognizing that manufactured products may still be considered materials. Initially this may seem troublesome, however, in the scope of complex manufactured products such as automobiles and satellites; is anyone really referring to those types of products as "materials"? As such, the word "discrete" is included, which in manufacturing parlance refers to distinct components such as brackets and microchips that can be assembled into a greater, more complex finished product. This means that while both a bolt and an automobile are manufactured "products," the bolt, as a discrete type of matter, can be justified as a material, whereas the automobile can't. Second—answering the question of "what if a particular matter exists today but hasn't been thoroughly studied to determine its value to researchers and industrialists?"—the definition recognizes that the material needs at a minimum recognition of a potential use case. This turns out to be OK, because if no use case has been identified, the matter still can be classified as an element, compound, or substance. It also insinuates that that element, compound, or substance with no use case isn't going to be used in the manufacturing of any material or product. Third, the definition also recognizes the recent phenomena of autonomous systems discovering new materials and whether or not those autonomous systems should be credited with inventorship.<ref>{{Cite journal |last=Ishizuki |first=Naoya |last2=Shimizu |first2=Ryota |last3=Hitosugi |first3=Taro |date=2023-12-31 |title=Autonomous experimental systems in materials science |url=https://www.tandfonline.com/doi/full/10.1080/27660400.2023.2197519 |journal=Science and Technology of Advanced Materials: Methods |language=en |volume=3 |issue=1 |pages=2197519 |doi=10.1080/27660400.2023.2197519 |issn=2766-0400}}</ref> The question of inventorship is certainly worth discussion, though it is beyond the scope of this guide. Regardless, the use of automated systems to match a set of properties of a particular matter to a real-world use case isn't likely to go away, and this definition accepts that likelihood. |
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| In 1998, the [[wikipedia:British Retail Consortium|British Retail Consortium]] (BRD) published the first edition of its Global Standard for Food Safety (GSFS), going on to become an internationally recognized standard of best practices in food manufacturing, storage, and distribution, and the first food safety standard to be recognized by the Global Food Safety Initiative (GFSI; discussed later). The standard covers stakeholder buy-in on continual improvement, food safety plan development, food quality management system development, manufacturing and storage site standardization, product and process control, personnel management, risk management, and trade product management.<ref name="PavlovićWhat17">{{cite web |url=https://www.ideagen.com/thought-leadership/blog/what-is-brc-global-food-safety-standard-explained |title=What is BRC? Global food safety standard explained |author=Pavlović, A. |work=Ideagen Blog |publisher=Ideagen Limited |date=26 June 2017 |accessdate=21 April 2023}}</ref><ref name="PJBRCGS20">{{cite web |url=https://www.pjfsc.com/Downloads/BRC-Overview.pdf |format=PDF |title=BRCGS - British Retail Consortium Global Standard |publisher=Perry Johnson Food Safety Consulting, Inc |date=April 2020 |accessdate=21 April 2023}}</ref><ref name="EagleFood19">{{cite web |url=https://vertassets.blob.core.windows.net/download/45fe7af4/45fe7af4-0500-4163-bd2b-5dd34e824bfd/eagle_wp_food_safetyquality_regulations_guide_a4_en.pdf |format=PDF |title=Food Safety and Quality Regulations: A Guide to Global Standards |publisher=Eagle Product Inspection |date=May 2019 |accessdate=21 April 2023}}</ref><ref name="BRCGSFS8_18">{{cite web |url=https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf |format=PDF |title=Global Standard Food Safety |author=British Retail Consortium |publisher=British Retail Consortium |date=August 2018 |accessdate=21 April 2023}}</ref> The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.<ref name="PJBRCGS20" />
| | Finally, this leads us to the realization that materials, by definition, are inherently linked to the act of intentional human- or automation-driven creation, i.e., manufacturing and construction. |
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| '''2.1.1.2 Codex Alimentarius'''
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| The [[wikipedia:Codex Alimentarius|Codex Alimentarius]] is a collection of internationally recognized food and feed standards and guidelines developed as a joint venture between the United Nation's Food and Agricultural Organization (FAO) and the [[World Health Organization]] (WHO).<ref name="EagleFood19" /> The Codex "is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade."<ref name="FAOCodexAbout">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/about-codex/en/#c453333 |title=About Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref> Scope of the standards is broad, covering food hygiene; food additives and contaminants, including pesticides and drugs; packaging and labelling; sampling and analysis methods; and import and export inspection and certification.<ref name="FAOCodexAbout" /> It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius.<ref name="FOAFood22">{{cite web |url=https://www.fao.org/food-safety/food-control-systems/policy-and-legal-frameworks/food-laws-and-regulations/en/ |title=Food laws & regulations |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref> Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969)<ref name="FAOCodes22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/codex-texts/codes-of-practice/en/ |title=Codes of Practice |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref>, General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).<ref name="FAOContam22">{{cite web |url=https://www.fao.org/fao-who-codexalimentarius/thematic-areas/contaminants/en/ |title=Contaminants |work=Codex Alimentarius |publisher=Food and Agricultural Organization |date=2022 |accessdate=21 April 2023}}</ref>
| | ===1.1 Materials testing labs, then and now=== |
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| '''2.1.1.3 Global Food Safety Initiative (GFSI)'''
| | ====1.1.1 Materials testing 2.0==== |
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| The [[wikipedia:Global Food Safety Initiative|GFSI]] is a collection of private organizations that has developed a set of benchmarking requirements for improving food safety management programs, with a goal of making them balanced enough to be broadly applicable while remaining relevant to different countries and regions of the world.<ref name="EagleFood19" /> Previously known as the GFSI Guidance Document<ref name="GFSIRelease17">{{cite web |url=https://mygfsi.com/press_releases/gfsi-releases-new-edition-of-benchmarking-requirements/ |title=GFSI Releases New Edition of Benchmarking Requirements |publisher=Global Food Safety Initiative |date=28 February 2017 |accessdate=21 April 2023}}</ref>, the GFSI Benchmarking Requirements act as a set of criteria and professional framework for food safety management programs to fulfill, formally allowing an organization to be recognized and certified by the GFSI. Certification to the GFSI Benchmarking Requirements "demonstrates an organization’s serious commitment to food safety to customers and potential customers across the world."<ref name="EagleFood19" /> An organization seeks out a third-party certification program owner (CPO) and undergoes the auditing process, which is driven and supported by the GFSI Benchmarking Requirements.<ref name="GFSICert22">{{cite web |url=https://mygfsi.com/how-to-implement/certification/ |title=Certification |publisher=Global Food Safety Initiative |date=2022 |accessdate=21 April 2023}}</ref> GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.
| | *https://onlinelibrary.wiley.com/doi/full/10.1111/str.12434 |
| | *https://onlinelibrary.wiley.com/doi/full/10.1111/str.12370 |
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| '''2.1.1.4 Hazard analysis and critical control points (HACCP)'''
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| The [[wikipedia:Hazard analysis and critical control points|hazard analysis and critical control points]] or HACCP system has been adopted and integrated in various ways over the years<ref name="WeinrothHist18">{{Cite journal |last=Weinroth |first=Margaret D |last2=Belk |first2=Aeriel D |last3=Belk |first3=Keith E |date=2018-11-09 |title=History, development, and current status of food safety systems worldwide |url=https://academic.oup.com/af/article/8/4/9/5087923 |journal=Animal Frontiers |language=en |volume=8 |issue=4 |pages=9–15 |doi=10.1093/af/vfy016 |issn=2160-6056 |pmc=PMC6951898 |pmid=32002225}}</ref>, but at its core, the system directs organizations to focus on key areas or "critical control points" (CCPs) of vulnerability and hazard within the production process and mitigate their impact on overall food safety.<ref name="EagleFood19" /> Though the seeds of HACCP go back to the 1970s, it wasn't until the mid-1990s that it began finding its way into formal regulatory structures in the United States, first codified as 9 CFR Parts 304, 308, 310, 320, 327, 381, 416, and 417 in July 1996.<ref name="WeinrothHist18" /><ref name="61FR38806">{{cite web |url=https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary |title=61 FR 38806 - Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems |work=Federal Register |publisher=U.S. Government Publishing Office |date=25 July 1996 |accessdate=21 April 2023}}</ref> HACCP also found its way into other standards benchmarked by the GFSI.<ref name="WeinrothHist18" /> The concept of HACCP has perhaps changed slightly over the years, but the main principles remain<ref name="EagleFood19" />:
| | ===1.2 Industries, products, and raw materials=== |
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| #Conduct a hazard analysis.
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| #Identify CCPs.
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| #Establish critical limits for those CCPs.
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| #Establish monitoring procedures for those CCPs.
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| #Establish corrective action for failed limits.
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| #Establish verification procedures.
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| #Establish record keeping and documentation procedures.
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| '''2.1.1.5 International Featured Standards (IFS)'''
| | ===1.3 Laboratory roles and activities in the industry=== |
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| The IFS framework is made up of a group of eight food and non-food standards, covering various processes along the food supply chain. IFS Management, who is responsible for the standards, notes that "IFS does not specify what these processes must look like but merely provides a risk-based assessment"<ref name="IFSHome">{{cite web |url=https://www.ifs-certification.com/en/ |title=IFS: Global Safety and Quality Standards |publisher=IFS Management GmbH |accessdate=21 April 2023}}</ref> or "uniform evaluation system"<ref name="EagleFood19" /> for them. Organizations such as food manufacturers and logistics providers can certify to the standards. Some of the more relevant to food and beverage laboratories include IFS Food (for food manufacturers), IFS Global Markets Food (for food retailers), IFS PACsecure 2 (for packaging manufactures), and IFS Global Markets PACsecure (for packaging suppliers).<ref name="IFSHome" />
| | ====1.3.1 R&D roles and activities==== |
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| '''2.1.1.6 International Organization for Standardization (ISO) 22000'''
| | ====1.3.2 Pre-manufacturing and manufacturing roles and activities==== |
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| The [[wikipedia:ISO 22000|ISO 22000]] series of standards addresses how a food safety management system should be set up and operated, and how organizations can be certified to the standard by a third-party auditor.<ref name="ISO22000">{{cite web |url=https://www.iso.org/iso-22000-food-safety-management.html |title=ISO 22000 Food safety management |publisher=International Organization for Standardization |accessdate=21 April 2023}}</ref> ISO 22000 is based off the [[ISO 9000]] family of [[quality management system]] standards and, like other standards, incorporates elements of HACCP.<ref name="WeinrothHist18" /> The standard claims to be advantaged compared to other standards due to its comprehensive applicability across an entire organization, and across the entire food chain.<ref name="ISO22000Home">{{cite web |url=https://committee.iso.org/home/tc34sc17 |title=ISO/TC34/SC17 |publisher=International Organization for Standardization |accessdate=21 April 2023}}</ref> Major standards applicable to manufacturers with laboratories include:
| | ====1.3.3 Post-production quality control and regulatory roles and activities==== |
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| *ISO/TS 22002-1:2009 ''Prerequisite programmes on food safety — Part 1: Food manufacturing''<ref name="ISO22002-1">{{cite web |url=https://www.iso.org/standard/44001.html |title=ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing |publisher=International Organization for Standardization |date=December 2009 |accessdate=21 April 2023}}</ref>
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| *ISO/TS 22002-4:2013 ''Prerequisite programmes on food safety — Part 4: Food packaging manufacturing''<ref name="ISO22002-4">{{cite web |url=https://www.iso.org/standard/60969.html |title=ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing |publisher=International Organization for Standardization |date=December 2013 |accessdate=21 April 2023}}</ref>
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| *ISO/TS 22002-6:2016 ''Prerequisite programmes on food safety — Part 6: Feed and animal food production''<ref name="ISO22002-6">{{cite web |url=https://www.iso.org/standard/66126.html |title=ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production |publisher=International Organization for Standardization |date=April 2016 |accessdate=21 April 2023}}</ref>
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| '''2.1.1.7 Safe Quality Food (SQF) Program'''
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| The SQF Program, headlined by the SQF Institute and recognized by the GFSI, is a food "safety-plus-quality" management certification mechanism that covers the food supply chain from farm to fork.<ref name="EagleFood19" /> Those who wish to be certified to SQF must comply with SQF Code, which covers a variety of topics, from aquaculture and farming to food packaging and food and feed manufacturing.<ref name="SQFCode">{{cite web |url=https://www.sqfi.com/resource-center/sqf-code-edition-9-downloads/ |title=SQF Code – Edition 9 Downloads |publisher=SQF Institute |date=24 May 2021 |accessdate=21 April 2023}}</ref> Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.
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| ====2.1.2 Materials====
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| [[File:Mechanical Testing Lab (5426178594).jpg|left|250px]]An internet search for "materials engineering standards" reveals dozens of university library research guides discussing what standards are, why they are important to materials science and engineering, and how to find them via the university's library system. Take for example UCLA's Materials Science and Engineering guide and its relatively succinct description of why standards are important to materials scientists<ref name="UCLAMaterials14">{{cite web |url=https://guides.library.ucla.edu/c.php?g=180271&p=1190840 |title=Materials Science and Engineering - Standards |work=UCLA Library Research Guides |publisher=UCLA Library |date=01 May 2014 |accessdate=21 April 2023}}</ref>:
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| <blockquote>Standards and specifications are described as documents that describe the rules and conditions for how materials and products should be manufactured, defined, measured, tested, and applied. They are used to establish baselines or a minimum level of performance and quality control to ensure that optimal conditions and procedures for the purpose of creating compatibility with products and services from different periods and a range of sources. Specifications have a more limited range of application than standards and generally establish requirements for materials, products, or services. Standards and specifications may be issued by voluntary technical or trade associations, professional societies, national standards bodies, government agencies, or by international organizations ... Standards and specifications are of greatest utility to engineers, scientists, and those working with new innovations.</blockquote>
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| UCLA helpfully goes on to describe the types of standards one should expect to find in regards to materials science and engineering, including categorical (e.g., dimension, structure, grade, durability, safety), method-based (e.g., manufacturing, design, operational safety), testing-based (e.g., analyzing, measuring, verifying), term-based (e.g., abbreviations, symbology, preferred units), and design (e.g., execution method, safety conditions) standards.<ref name="UCLAMaterials14" /> As such, it would be practically impossible to address all materials-related standards in this guide. However, a small selection of examples are provided to give varying contexts of what materials engineers and manufacturers may need to consider.
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| '''2.1.2.1 American Society of Civil Engineers (ASCE) materials standards'''
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| The ASCE is a professional organization with its own library of standards, including materials standards for engineering. Examples include ASCE/T&DI/ICPI 58-16 ''Structural Design of Interlocking Concrete Pavement for Municipal Streets and Roadways'', ASCE/SEI 19-16 ''Structural Applications of Steel Cables for Buildings'', and ASCE/SEI 48-05 ''Design of Steel Transmission Pole Structures''.
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| '''2.1.2.2 ASTM International Volume 15.04'''
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| ASTM International has numerous volumes of standards for materials, including Volume 15.04. This volume covers the chemical requirements for soaps and other detergents, the properties of polishes, various properties and test methods of leather, and the properties of floor coverings.<ref name="ASTMVol15.04">{{cite web |url=https://www.astm.org/astm-bos-15.04.html |title=ASTM Volume 15.04: Soaps And Other Detergents; Polishes; Leather; Resilient Floor Coverings |publisher=ASTM International |date=September 2022 |accessdate=25 April 2023}}</ref>
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| '''2.1.2.3 Canadian Standards Association (CSA) A3000 series'''
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| The CSA produces standards for a variety of materials, including cementitious materials through its A3000 series of standards. These construction materials standards address the basics of cementitious materials, their appropriate test methods, and the equipment best used for those methods.<ref name="CSAA3000-18">{{cite web |url=https://www.csagroup.org/store/product/A3000-18/ |title=A3000-18 Cementitious materials compendium |publisher=CSA Group |date=2018 |accessdate=25 April 2023}}</ref>
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| '''2.1.2.4 International Organization for Standardization (ISO) 10993'''
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| Generally speaking, there are no ISO or government-sanctioned standards for the materials that can be used in [[medical device]]s, but rather there are standards that apply directly to medical devices, largely given that the overall manufacturing process has a tendency to modify the reactivity of the material used in the medical device.<ref name="ECMaterial21">{{cite web |url=https://www.essentracomponents.com/en-us/news/industries/medical-equipment/material-standards-for-medical-manufacturing |title=Material standards for medical manufacturing |publisher=Essentra Components |date=28 October 2021 |accessdate=21 April 2023}}</ref> That being said, there is an ISO standard for biocompatibility, "the ability of a device material to perform with an appropriate host response in a specific situation"<ref name="FDAGloss21">{{cite web |url=https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/glossary-biocompatibility-terms |title=Glossary of Biocompatibility Terms |publisher=U.S. Food and Drug Administration |date=18 March 2021 |accessdate=21 April 2023}}</ref>: the ISO 10993 series of standards.<ref name="ECMaterial21" /> These standards requires manufacturers of medical devices to collect "qualitative and quantitative data on the materials in the context of biological safety" to ensure the device's material is actually biocompatible.<ref name="ECMaterial21" /> ISO 10933 addresses chemical characterization, allowable limits of leachable substances, and ''in vitro'' cytotoxicity of medical device materials, among other things.<ref name="ECMaterial21" />
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| '''2.1.2.5 Metal Powder Industries Federation (MPIF) Standard 35 family'''
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| The MPIF "issues standards to provide the design and materials engineer with the information necessary for specifying powder metallurgy materials which have been developed by the powder metallurgy and metal injection molding parts, powder, and equipment producers."<ref name="MPIFStand23">{{cite web |url=https://www.mpif.org/Resources/Standards.aspx |title=Standards |publisher=Metal Powder Industries Federation |date=2023 |accessdate=25 April 2023}}</ref> Among them is the Standard 35 family, which addresses powder metallurgy structural parts and self-lubricating bearings, as well as powder-forged steel and metal injection molded parts, including materials aspects such as "minimum strength value, grade selection, chemistry, proof testing, typical property values, and processes."<ref name="MPIFStand23" />
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| ====2.1.3 Pharmaceutical and medical devices====
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| [[File:A technician looks at samples at the pharmaceutical lab in Rockville, Maryland LCCN2011631564.tif|right|250px]]Of the various manufacturing domains, pharmaceutical and [[medical device manufacturing]] arguably requires some of the most rigorous standards to ensure the good health of end users. Speaking to consumer expectations of safe, high-quality pharmaceutical products, Atouf and Venema note<ref>{{Cite journal |last=Atouf |first=Fouad |last2=Venema |first2=Jaap |date=2020-08 |title=Do Standards Matter? What is Their Value? |url=https://linkinghub.elsevier.com/retrieve/pii/S0022354920302409 |journal=Journal of Pharmaceutical Sciences |language=en |volume=109 |issue=8 |pages=2387–2392 |doi=10.1016/j.xphs.2020.04.017}}</ref>:
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| <blockquote>The consistency in both the safety and efficacy of the drug supply required to achieve this assurance is based mainly on our reliance on compendial standards for quality and performance of drug development, review, and ongoing manufacturing. These standards are recognized in the [Food, Drug and Cosmetic Act] and play a critical role in its adulteration and misbranding provisions ... The impact of established and accepted standards—in the form of measurements and methods as well as reference materials—being a norm for drug development often goes unnoticed and unmeasured, even by those intimately involved in the field. By the very fact of being the norm, they are taken for granted. Their impact is nonetheless fundamental to the current and future efficiency of drug development as well as to the pursuit of providing safe, high-quality medicines at a reasonable price.</blockquote>
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| Similarly, harmonized medical device standards are valuable to manufacturers and end users, making it "possible to apply essential requirements" of development and manufacturing "in a uniform way." Manufacturers can adopt harmonized standards in such a way that design and documentation costs are reduced, while at the same time giving end users more confidence in the safety and efficacy of manufactured devices.<ref name="StinshoffRole04">{{cite web |url=https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/wsc-medtech_10_klaus_stinshoff_text.pdf |format=PDF |title=Role of Standards in the Assessment of Medical Devices |author=Stinshoff, K.E. |publisher=International Organization for Standardization |date=2004 |accessdate=26 April 2023}}</ref>
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| Like materials standards, it's beyond the scope of this guide to try and list all pharmaceutical and medical device standards. What follows are a few examples of more critical standards in this industry.
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| '''2.1.3.1 ASTM International Volume 14.01'''
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| ASTM International covers pharmaceutical and biopharmaceutical manufacturing in its Volume 14.01. In particular, it "covers the application of process analytical technology (PAT) within the pharmaceutical and biopharmaceutical industry, highlighting PAT system management, implementation, and practices."<ref name="ASTMVol14.01">{{cite web |url=https://www.astm.org/astm-bos-14.01.html |title=ASTM Volume 14.01: Statistical Methods; Hazard Potential Of Chemicals; Thermal Measurements; Manufacture Of Pharmaceutical And Biopharmaceutical Products; Healthcare Informatics |publisher=ASTM International |date=June 2022 |accessdate=25 April 2023}}</ref>
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| '''2.1.3.2 European Pharmacopoeia standards'''
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| The European Pharmacopoeia is a compendium of standards—in the form of monographs and other documents—that provides "a legal and scientific basis for quality control during the development, production and marketing" of pharmaceuticals and their ingredients. These standards address the compositions, testing, and handling of medicines and their ingredients to better ensure the safety of consumers and a more effective product.<ref name="EPAbout">{{cite web |url=https://www.edqm.eu/en/background-and-mission |title=European Pharmacopoeia - Background and Mission |publisher=Council of Europe |accessdate=26 April 2023}}</ref> The eleventh edition contains more than 2,400 monographs, 380 general texts, and 2,800 descriptions of reagents.<ref name="EPEleventh">{{cite web |url=https://www.edqm.eu/en/european-pharmacopoeia-ph.-eur.-11th-edition |title=European Pharmacopoeia (Ph. Eur.) 11th Edition |publisher=Council of Europe |accessdate=26 April 2023}}</ref> While legally binding in European member countries, the standards also have international relevance.<ref name="EPAbout" />
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| '''2.1.3.3 International Organization for Standardization (ISO) 10993, 13485, and 16142-2'''
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| As described in the previous subsection, the ISO 10993 series of standards addresses the biocompatibility of medical device materials. ISO 13485 is the primary [[quality management system]] (QMS) standard for hardware- and software-based medical devices and their demonstration of meeting or exceeding customer and regulatory requirements. By meeting the requirements of ISO 13485, the manufacturer facilitates "an improvement of processes" within their workflows over the complete lifecycle of operations.<ref>{{Cite book |last=Abuhav |first=Itay |date=2018 |title=ISO 13485:2016: a complete guide to quality management in the medical device industry |chapter=1. Scope |edition=Second edition |publisher=CRC Press, Taylor & Francis Group |place=Boca Raton London New York |pages=1–7 |isbn=978-1-351-00077-2}}</ref> ISO 16142-2 "identifies and describes the six general essential principles of safety and performance ... that apply to all medical devices, including IVD medical devices (in vitro diagnostic)," while also addressing the safety and performance requirements for designing and manufacturing medical devices.<ref name="ISO16142-2_17">{{cite web |url=https://www.iso.org/standard/63940.html |title=ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |publisher=International Organization for Standardization |dateAugust 2017 |accessdate=26 April 2023}}</ref>
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| '''2.1.3.4 United States Pharmacopeia and National Formulary (USP-NF) standards'''
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| Like its European counterpart, the USP-NF acts as a compendium of thousands of quality standards for pharmaceutical products and their active and inactive ingredients, helping manufacturers better protect patient safety while also producing higher-quality medicines. Three broad types of standards make up the compendium: monographs, general chapters, and material reference standards. Monographs "articulate the quality expectations for a medicine" and "describe the tests to validate" the medicine's ability to meet those expectations.<ref name="USPAnOver">{{cite web |url=https://www.usp.org/about/public-policy/overview-of-monographs |title=An Overview of USP Monographs |publisher=United States Pharmacopeia |accessdate=26 April 2023}}</ref> General chapters take a broad approach to product development and manufacturing, discussing accepted processes, tests, and methods for pharmaceuticals. Material reference standards complement monographs and general chapters with their quality testing methods to ensure medicines adhere to the state requirements of monographs and general chapters.<ref name="USPAnOver" />
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| ====2.1.4 Other industries and standards====
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| [[File:COVID-19-related research (49938485863).png|left|400px]]From our North American Industry Classification System (NAICS)-derived list of manufacturing industries in Chapter 1, we know there's more to manufacturing than food and beverage, materials, and pharmaceuticals and medical devices. Apparel, electronics, furniture, plastics, and petrochemical manufacturers—to name a few—have their own standards. It is beyond the scope of this guide to cover every industry; however, this subsection will highlight a few examples of standards that are applicable to a wide variety of other industries, including the all-important [[ISO 9000|ISO 9001]] standard.
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| '''2.1.4.1 British Standards Institution (BSI) standards'''
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| BSI is appointed by the United Kingdom as the national standards body and seeks to "improve the quality and safety of products, services and systems by enabling the creation of standards and encouraging their use."<ref name="BSIAbout">{{cite web |url=https://www.bsigroup.com/en-GB/about-bsi/uk-national-standards-body/ |title=UK national standards body |publisher=British Standards Institution |date=2023 |accessdate=26 April 2023}}</ref> BSI works in tandem with the ISO to address the standards needs of the U.K. Addressed among its standards are the topics of quality, supply chain, health and safety, and automation.<ref name="BSIManu">{{cite web |url=https://www.bsigroup.com/en-US/Industries-and-sectors/manufacturing-and-processing/ |title=Manufacturing |publisher=British Standards Institution |date=2023 |accessdate=26 April 2023}}</ref> An example of a manufacturing standard is BS EN 1090, which addresses "structural/construction steel and aluminum products that are installed in a permanent manner."<ref name="BSIBSEN1090">{{cite web |url=https://www.bsigroup.com/en-GB/our-services/product-certification/ce-mark/eu-directives/construction-products-regulation-cpr/en-1090-structural-steel/ |title=BS EN 1090 - Structural steel and aluminium |publisher=British Standards Institution |date=2023 |accessdate=26 April 2023}}</ref>
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| '''2.1.4.2 Global Standard's Global Organic Textile Standard (GOTS)'''
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| Global Standard's GOTS is described as "the worldwide leading textile processing standard for organic fibres, including ecological and social criteria, backed up by independent third-party certification of the entire textile supply chain."<ref name="GSGOTS">{{cite web |url=https://global-standard.org/the-standard/gots-key-features |title=Key Features |publisher=Global Standard GmbH |date=2023 |accessdate=26 April 2023}}</ref> The standard's breadth covers the entire spectrum of textile manufacturing, from design and processing to final distribution. Global Standards also provides an implementation manual for organizations with questions about the standard's implementation.<ref name="GOTSMan">{{cite web |url=https://global-standard.org/the-standard/development-and-implementation#manual |title=Development and Implemetation - Implementation Manual |publisher=Global Standard GmbH |date=2023 |accessdate=26 April 2023}}</ref>
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| '''2.1.4.3 International Organization for Standardization (ISO) 9001'''
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| ISO 9001 specifies the requirements for a QMS within any organization providing products and services, particularly those seeking to prove their products and services consistently meet customer and regulatory requirements and necessarily enhance customer satisfaction.<ref name="ISO9001_15">{{cite web |url=https://www.iso.org/standard/62085.html |title=ISO 9001:2015 Quality management systems — Requirements |publisher=International Organization for Standardization |date=September 2015 |accessdate=26 April 2023}}</ref> While it does not define product quality, by focusing on the QMS, a manufacturer typically by extension produces products of a higher quality. (Though, broadly speaking, such improvement is partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.<ref name="Heras">{{cite journal |title=ISO 9000 registration's impact on sales and profitability: A longitudinal analysis of performance before and after accreditation |last1=Heras |first1=Iñaki |last2=Dick |first2=Gavin P.M. |last3=Casadesús |first3=Martí |journal=International Journal of Quality & Reliability Management |volume=19 |issue=6 |year=2002 |pages=774–791 |doi=10.1108/02656710210429618}}</ref>) The standard applies to manufacturers big and small across any industry, and as such, ISO 9001 requires the organization to closely consider its context within its industry and business environment in order to make the most of the standard.<ref>{{Cite book |last=Abuhav, I. |year=2017 |title=ISO 9001: 2015 - A Complete Guide to Quality Management Systems |url=https://books.google.com/books?id=NmUlDgAAQBAJ&printsec=frontcover |chapter=Chapter 4 Context of the Organization |publisher=CRC Press |isbn=9781498733212}}</ref>
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| '''2.1.4.4 Underwriter Laboratories (UL) standards'''
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| UL says its standards "are used to assess products; test components, materials, systems and performance; and evaluate environmentally sustainable products, renewable energies, food and water products, recycling systems and other innovative technologies."<ref name="ULAbout">{{cite web |url=https://ulstandards.ul.com/about/ |title=About |publisher=Underwriter Laboratories |date=2023 |accessdate=26 April 2023}}</ref> When looking at their catalog of standards, the breadth of products—and therefore industries—becomes more apparent, from electrical conduit, thermostat wiring, energy storage systems, and fire extinguishers to electric gardening devices, elevator door locks and contacts, garment finishing appliances, and gasoline.<ref name="ULStandardsCat">{{cite web |url=https://www.shopulstandards.com/Catalog.aspx |title=Standards & Publications |publisher=Underwriter Laboratories |date=2023 |accessdate=26 April 2023}}</ref> If it can be manufactured in your industry, UL may have a standard for it.
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| ===2.2 Regulations and laws around the world===
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| As the end of Chapter 1 highlighted, today's regulatory focus on product safety, quality, and efficacy is largely built on the past failures, injuries, and deaths that highlighted the regulatory need.<ref>{{Cite book |last=Center for Policy Alternatives at the Massachusetts Institute of Technology |year=1980 |title=Benefits of Environmental, Health, and Safety Regulation |url=https://books.google.com/books?id=VadeKZOzcmwC&pg=PA1 |publisher=U.S. Government Printing Office |pages=100}}</ref><ref name="AschConsum88">{{Cite book |last=Asch |first=Peter |date=1988 |title=Consumer safety regulation: putting a price on life and limb |url=https://books.google.com/books?id=Pi_nCwAAQBAJ&pg=PA1 |publisher=Oxford University Press |place=New York |pages=3–14 |isbn=978-0-19-504972-5}}</ref><ref>{{Cite book |last=Dwyer |first=Tom |date=1991 |title=Life and death at work: industrial accidents as a case of socially produced error |series=Plenum studies in work and industry |publisher=Plenum Press |place=New York |isbn=978-0-306-43949-0}}</ref><ref>{{Cite book |last=CoVan |first=James |date=1995 |title=Safety engineering |series=New dimensions in engineering |publisher=Wiley |place=New York |isbn=978-0-471-55612-1}}</ref> For example, the consumption of raw milk was associated with a growing number of health issues in the mid- to late 1800s, particularly milk from unscrupulous dairy farms. 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> By 1939, the U.S. Public Health Services had drafted the Model Milk Health Ordinance "in order to encourage a greater uniformity of milk-control practice in the United States."<ref name="PHSMilk39">{{cite web |url=http://resource.nlm.nih.gov/101528318 |title=Milk ordinance and code: Recommended by the United States Public Health Service, 1939 |author=U.S. Public Health Service |publisher=U.S. Government Printing Office |date=1939 |accessdate=26 April 2023}}</ref>
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| While regulation can at times be overbearing and harmful, well-crafted regulations can definitely benefit our society. This can be seen with manufacturing regulations driven on safety, quality, and efficacy principles. How those regulations are implemented around the world may differ slightly, however, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.<ref name="BuzbyFood03">{{cite web |url=https://www.ers.usda.gov/amber-waves/2003/november/food-safety-and-trade-regulations-risks-and-reconciliation/ |title=Food Safety and Trade: Regulations, Risks, and Reconciliation |author=Buzby, J.C.; Mitchell, L. |work=Amber Waves |publisher=U.S. Department of Agriculture, Economic Research Service |date=01 November 2003 |accessdate=21 April 2023}}</ref>
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| The following subsections examine some of the more critical regulations that apply to a wide variety of manufacturing industries, from various parts of the world.
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| ====2.2.1 Food and beverage====
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| The safety and quality of food is a high priority for most countries around the world, though how that safety and quality is regulated and legislated varies, sometimes significantly. The following subsections briefly address the primary regulations and legislation enacted in seven major countries and supranational unions around the world. (It is beyond the scope of this guide to address them all.) Similarities among the countries may be seen in their goals, but it should be noted that differences—significant and nuanced—exist among them all in regards to regulatory approaches to sampling, testing, risk, and importing of products.<ref name="BuzbyFood03" /><ref name="WestGlobal18">{{cite web |url=https://www.brookings.edu/research/global-manufacturing-scorecard-how-the-us-compares-to-18-other-nations/ |title=Global manufacturing scorecard: How the US compares to 18 other nations |author=West, D.M.; Lansang, C. |work=Brookings |date=10 July 2018 |accessdate=26 April 2023}}</ref><ref name="GAOFoodSafety05">{{cite web |url=https://www.gao.gov/products/gao-05-212 |title=Food Safety: Experiences of Seven Countries in Consolidating Their Food Safety Systems |author=U.S. Government Accountability Office |date=February 2005 |accessdate=21 April 2023}}</ref><ref name="WhitworthReport22">{{cite web |url=https://www.foodsafetynews.com/2022/02/report-finds-food-testing-policies-different-between-countries/ |title=Report finds food testing policies different between countries |author=Whitworth, J. |work=Food Safety News |date=22 February 2022 |accessdate=21 April 2023}}</ref>
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| '''2.2.1.1 Food Safety Act 1990 and Food Standards Act 1999 - ''United Kingdom'''''
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| The [[wikipedia:Food Safety Act 1990|Food Safety Act of 1990]] and [[wikipedia:Food Standards Agency|Food Standards Act of 1999]] represent the core of food safety regulation in the United Kingdom, though there are other pieces of legislation that also have an impact.<ref name="SBCFood22">{{cite web |url=https://www.scarborough.gov.uk/home/business-licensing-and-grants/food-hygeine/food-safety-regulations |archiveurl=https://web.archive.org/web/20230203164750/https://www.scarborough.gov.uk/home/business-licensing-and-grants/food-hygeine/food-safety-regulations |title=Food safety regulations |publisher=Scarborough Borough Council |date=10 November 2022 |archivedate=03 February 2023 |accessdate=21 April 2023}}</ref><ref name="FSAKey22">{{cite web |url=https://www.food.gov.uk/about-us/key-regulations |title=Key regulations |publisher=Food Standards Agency |date=30 August 2022 |accessdate=21 April 2023}}</ref> The Food Safety Act of 1990 encourages entities to "not include anything in food, remove anything from food, or treat food in any way which means it would be damaging to the health of people eating it"; serve or sell food that is of a quality that "consumers would expect"; and ensure food is labeled, advertised, and presented clearly and truthfully.<ref name="SBCFood22" /><ref name="FSAKey22" /> The Food Standards Act of 1999 later created the UK's Food Standards Agency (FSA) "to protect public health from risks which may arise in connection with the consumption of food (including risks caused by the way in which it is produced or supplied) and otherwise to protect the interests of consumers in relation to food."<ref name="FSA99Sec1">{{cite web |url=https://www.legislation.gov.uk/ukpga/1999/28/section/1 |title=1999 c. 28, The Food Standards Agency, Section 1 |work=legislation.gov.uk |accessdate=21 April 2023}}</ref> One of the ways the FSA does this is through enforcing food safety regulation at the local level, including within food production facilities, as well as setting ingredient and nutrition labelling policy.<ref name="FSAAbout">{{cite web |url=https://www.gov.uk/government/organisations/food-standards-agency |title=Food Standards Agency |work=Gov.uk |accessdate=21 April 2023}}</ref> Regulations and guidance from the FSA address not only labelling but also radioactivity monitoring, meat processing, manure management, ''Salmonella'' testing, temperature control, dairy hygiene, and more.<ref name="FSAGuidReg">{{cite web |url=https://www.gov.uk/search/guidance-and-regulation?organisations%5B%5D=food-standards-agency&parent=food-standards-agency |title=Guidance and regulation: Food Standards Agency (FSA) |work=Gov.uk |accessdate=21 April 2023}}</ref>
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| '''2.2.1.2 Food Safety and Standards Act of 2006 - ''India'''''
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| This act was enacted in 2006 to both consolidate existing food-related law and to establish the Food Safety and Standards Authority of India (FSSAI), which develops regulations and standards of practice for the manufacture, storage, distribution, and packaging of food.<ref name="PRSImplement">{{cite web |url=https://prsindia.org/policy/report-summaries/implementation-food-safety-and-standards-act-2006 |title=Implementation of Food Safety and Standards Act, 2006 |work=PRS Legislative Research |accessdate=21 April 2023}}</ref><ref name="FSSAIFood">{{cite web |url=https://fssai.gov.in/cms/food-safety-and-standards-act-2006.php |title=Food Safety and Standards Act, 2006 |publisher=Food Safety and Standards Authority of India |accessdate=21 April 2023}}</ref> However, an audit of FSSAI by the Comptroller and Auditor General of India (CAG) in December 2017 revealed some deficiencies in the FSSAI's activities, including an overall "low quality" of food testing laboratories in the country.<ref name="PRSImplement" /> Nonetheless, the FSSAI remains the primary regulatory watchdog, developing standards and guidelines for food and enforcing those standards. This includes setting limits for food additives, contaminants, pesticides, drugs, heavy metals, and more, as well as defining quality control mechanisms, accreditation requirements, sampling and analytical techniques, and more.<ref name="FSSAIFood" />
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| '''2.2.1.3 Food Safety Law - ''China'''''
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| The [[wikipedia:Food safety in China|Food Safety Law]] is described as "the fundamental law regulating food safety in China."<ref name="UNEPFood15">{{cite web |url=https://leap.unep.org/countries/cn/national-legislation/food-safety-law-2015 |title=Food Safety Law (2015) |author=Food and Agriculture Organization of the United Nations |work=Law and Environment Assistance Platform |publisher=United Nations Environmental Programme |date=24 April 2015 |accessdate=21 April 2023}}</ref> Enacted in 2009 and revised in 2015, the Law "builds up the basic legal framework for food safety supervision and management" and "introduces many new regulatory requirements," including "not only general requirements applicable to food and food additives, but also specific requirements for food-related products and other product categories."<ref name="UNEPFood15" /> Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.<ref name="USDAChina15">{{cite web |url=https://apps.fas.usda.gov/newgainapi/api/report/downloadreportbyfilename?filename=Amended%20Food%20Safety%20Law%20of%20China_Beijing_China%20-%20Peoples%20Republic%20of_5-18-2015.pdf |format=PDF |title=China's Food Safety Law (2015) |author=Foreign Agriculture Service Staff |publisher=U.S. Department of Agriculture |work=GAIN Repo |date=18 May 2015 |accessdate=21 April 2023}}</ref>
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| '''2.2.1.4 Food Sanitation Act and Food Safety Basic Act - ''Japan'''''
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| The Food Sanitation Act of 1947 and the Food Safety Basic Act of 2003 represent the most important pieces of food-related legislation in Japan, though there are others. The Food Sanitation Act was originally enacted "to prevent sanitation hazards resulting from eating and drinking by enforcing regulations and other measures necessary from the viewpoint of public health, to ensure food safety and thereby to protect citizens' health."<ref name="JLTFood47">{{cite web |url=https://www.japaneselawtranslation.go.jp/en/laws/view/3687/en |title=Food Sanitation Act (Act No. 233 of 1947) |work=Japanese Law Translation |date=24 December 1947 |accessdate=21 April 2023}}</ref> The Food Safety Basic Act recognized the effects of "internationalization" and changing dietary habits, as well as scientific and technological shifts in food production, as a primary driver for modernizing food safety and sustainability in the country, and it also created the Food Safety Commission of Japan.<ref name="FSCFoodSafe03">{{cite web |url=https://www.fsc.go.jp/english/basic_act/fs_basic_act.pdf |format=PDF |title=Food Safety Basic Act |publisher=Food Safety Commission of Japan |date=23 May 2003 |accessdate=21 April 2023}}</ref> Between the two pieces of legislation, standards and specifications for food and food additives, as well as associated tools and packaging, are addressed, as are inspection standards, production standards, hygiene management, and individual food and ingredient safety.<ref name="BMFoodJapan18">{{cite web |url=https://resourcehub.bakermckenzie.com/en/resources/asia-pacific-food-law-guide/asia-pacific/japan/topics/food-product-and-safety-regulation |title=Japan: Food product and safety regulation |work=Asia Pacific Food Law Guide |author=Baker McKenzie |date=2018 |accessdate=21 April 2023}}</ref>
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| '''2.2.1.5 Food Safety Modernization Act (FSMA) and other acts - ''United States'''''
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| [[File:Food-safety-modernization-act-fsma.png|right|300px]]The [[wikipedia:FDA Food Safety Modernization Act|Food Safety Modernization Act]] of the United States was signed into law in January 2011, giving the US Food and Drug Administration (FDA) more regulatory authority to address the way food is grown, harvested, and processed.<ref name="WeinrothHist18">{{Cite journal |last=Weinroth |first=Margaret D |last2=Belk |first2=Aeriel D |last3=Belk |first3=Keith E |date=2018-11-09 |title=History, development, and current status of food safety systems worldwide |url=https://academic.oup.com/af/article/8/4/9/5087923 |journal=Animal Frontiers |language=en |volume=8 |issue=4 |pages=9–15 |doi=10.1093/af/vfy016 |issn=2160-6056 |pmc=PMC6951898 |pmid=32002225}}</ref><ref name="FDAFood22">{{cite web |url=https://www.fda.gov/animal-veterinary/animal-food-feeds/food-safety-modernization-act-and-animal-food |title=Food Safety Modernization Act and Animal Food |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=21 April 2023}}</ref> It has been described by the FDA as "the most sweeping reform of our food safety laws in more than 70 years."<ref name="FDAFood22" /> The FSMA, at its base, has five key aspects, addressing preventive controls, inspection and compliance, safety of food imports, mandatory recall response, and food partnership enhancement.<ref name="FDAFood22" /> However, FSMA continues to evolve, with additional rules getting added since its enactment, including rules about record management, good manufacturing practice (GMP) for human food and animal feed, and laboratory accreditation (referred to as the [[LII:FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors|LAAF Rule]]).<ref name="FDAFSMA22">{{cite web |url=https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#rules |title=FSMA Rules & Guidance for Industry |publisher=U.S. Food and Drug Administration |date=20 October 2022 |accessdate=21 April 2023}}</ref>
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| Another important regulatory body in the US is the Food Safety and Inspection Service (FSIS), which is overseen by the US Department of Agriculture (USDA). The FSIS and its authority to regulate are derived from three different acts: the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957, and the Egg Products Inspection Act of 1970.<ref name="USDAOurHist18">{{cite web |url=https://www.fsis.usda.gov/about-fsis/history |title=Our History |author=Food Safety and Inspection Service |publisher=U.S. Department of Agriculture |date=21 February 2018 |accessdate=21 April 2023}}</ref> The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.<ref name="9CFR412">{{cite web |url=https://www.ecfr.gov/current/title-9/chapter-III/subchapter-E/part-412 |title=9 CFR Part 412 - Label Approval |work=Code of Federal Regulations |date=31 October 2022 |accessdate=21 April 2023}}</ref><ref name="FSISFedReg">{{cite web |url=https://www.fsis.usda.gov/policy/federal-register-rulemaking/federal-register-rules |title=Federal Register Rules |publisher=Food Safety and Inspection Service |accessdate=21 April 2023}}</ref><ref name="NALFoodSafe">{{cite web |url=https://www.nal.usda.gov/human-nutrition-and-food-safety/food-safety-standards |title=Food Safety Standards |author=National Agricultural Library |publisher=U.S. Department of Agriculture |accessdate=21 April 2023}}</ref>
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| '''2.2.1.6 General Food Law Regulation (GFLR) - ''European Union'''''
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| The GFLR was enacted across the European Union in 2002 as part of Regulation (EC) No 178/2002, and it is described as "the foundation of food and feed law" for the EU.<ref name="EUGeneral">{{cite web |url=https://food.ec.europa.eu/horizontal-topics/general-food-law_en |title=General Food Law |work=Food Safety |publisher=European Commission |accessdate=21 April 2023}}</ref> Along with setting requirements and procedures for food and feed safety, the GFLR also mandated the creation of the European Food Safety Authority (EFSA), an independent body assigned to developing sound scientific advice about and providing support towards the goals of food, beverage, and feed safety in the EU.<ref name="WeinrothHist18" /><ref name="EUGeneral" /> As such, the EFSA develops broad and sector-specific guidance<ref name="EFSAGuidance">{{cite web |url=https://www.efsa.europa.eu/en/methodology/guidance |title=Guidance and other assessment methodology documents |publisher=European Food Safety Authority |accessdate=21 April 2023}}</ref>, as well as other rules related to scientific assessment of food safety matters, e.g., Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.<ref name="EU2073-2005">{{cite web |url=https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32005R2073 |title=Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs |work=EUR-Lex |date=03 August 2020 |accessdate=21 April 2023}}</ref> The EFSA also develops food classification standardization tools such as the Standard Sample Description (SSD2) data model, to better ensure an appropriate "format for describing food and feed samples and analytical results that is used by EFSA’s data providers."<ref name="EFSAFoodClass">{{cite web |url=https://www.efsa.europa.eu/en/data/data-standardisation |title=Food classification standardisation – The FoodEx2 system |publisher=European Food Safety Authority |accessdate=21 April 2023}}</ref>
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| '''2.2.1.7 Safe Food for Canadians Act (SFCA) - ''Canada'''''
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| In November 2012, the SFCA was enacted to place regulatory "focus on prevention to ensure a food that is imported, exported or shipped from one province to another, is manufactured, stored, packaged and labelled in a way that does not present a risk of contamination."<ref name="ManitobaSafe">{{cite web |url=https://www.gov.mb.ca/agriculture/food-safety/at-the-food-processor/safe-food-for-canadians-act.html |title=Safe Food for Canadians Act |publisher=Manitoba Government |accessdate=21 April 2023}}</ref><ref name="JLWSafeFood19">{{cite web |url=https://laws-lois.justice.gc.ca/eng/acts/s-1.1/index.html |title=Safe Food for Canadians Act (S.C. 2012, c. 24) |work=Justice Laws Website |publisher=Government of Canada |date=17 June 2019 |accessdate=21 April 2023}}</ref> Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019<ref name="ManitobaSafe" />, the consolidation of 14 sets of existing food regulations by the SFCA has managed to improve consistency, reduce administrative burden, and enable food business innovation.<ref name="GoCUnder18">{{cite book |last=Canadian Food Inspection Agency |year=2018 |title=Understanding the Safe Food for Canadians Regulations: A handbook for food businesses |url=https://inspection.canada.ca/food-safety-for-industry/toolkit-for-food-businesses/sfcr-handbook-for-food-businesses/eng/1481560206153/1481560532540?chap=0 |publisher=Government of Canada |isbn=9780660269856}}</ref> An interpretive guide published by the CFIA, ''Understanding the Safe Food for Canadians Regulations: A handbook for food businesses'', summarizes and explains some of the nuances of the SFCA and its 16 parts on matters such as trade, licensing, preventive controls, packaging and labeling, and traceability.<ref name="GoCUnder18" />
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| ====2.2.2 Materials====
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| [[File:Assessing prototype reference material for testing emissions of VOCs (5940985174).jpg|left|330px]]
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| Like materials standards, there are too many materials regulations to list for the given scope of this guide. However, several different examples are given below of materials-related regulations found in various parts of the world.
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| '''2.2.2.1 21 CFR Part 175 and 176 - ''United States'''''
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| These two regulations from the U.S. Code of Federal Regulations system relate specifically to the materials used to package food. (While the food and beverage industry is the recipient and end user of such materials, the materials researcher and manufacturer is responsible, in part, for developing and producing materials that meet such regulations.) Part 175 dictates what substances can be used as components of adhesives and coatings in food packaging materials<ref name="ECFR21Part175">{{cite web |url=https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175?toc=1 |title=Title 21, Chapter I, Subchapter B, Part 175 |work=Code of Federal Regulations |publisher=Office of the Federal Register; U.S. Government Publishing Office |date=24 April 2023 |accessdate=26 April 2023}}</ref>, and Part 176 addresses what substances can be used as components of paper and paperboard in food packaging materials.<ref name="ECFR21Part176">{{cite web |url=https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-175?toc=1 |title=Title 21, Chapter I, Subchapter B, Part 176 |work=Code of Federal Regulations |publisher=Office of the Federal Register; U.S. Government Publishing Office |date=24 April 2023 |accessdate=26 April 2023}}</ref>
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| '''2.2.2.2 Building Standard Law - ''Japan'''''
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| Japan's Building Standard Law, broadly speaking, states a minimum set of standards that must be followed concerning the construction of buildings in the country, in order to protect the health and property of those using those buildings. Given the country's infrastructure is affected by snow accumulation, earthquakes, and tsunamis, a modern approach to building regulation was required in 1950. One section of the law addresses the quality of materials used in building construction, particularly in important sections of the home such as the foundation, load-bearing walls, columns, and more. The regulation mandates that such materials must conform to the Japanese Industrial Standard or Japanese Agriculture Standard or be specifically approved by the Minister. This means manufacturers of structural steel, high-strength bolts, concrete, wood-based composite panels, membrane materials, and more are largely beholden to those standards throughout the manufacturing process.<ref name="TomohiroIntro13">{{cite web |url=https://www.bcj.or.jp/upload/international/baseline/BSLIntroduction201307_e.pdf |format=PDF |title=Introduction to the Building Standard Law, Building Regulation in Japan |author=Tomohiro, H. |publisher=Building Center of Japan |date=July 2013 |accessdate=26 April 2023}}</ref>
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| '''2.2.2.3 The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - ''United Kingdom'''''
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| In 1988, the U.K. made into law The Furniture and Furnishings (Fire) (Safety) Regulations, which "were introduced to help reduce the risks of injury or loss of life through fires in the home spread by upholstered furniture."<ref name="OPSSUpdat19">{{cite web |url=https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/822072/furniture-fire-regulations-2016-consultation-government-response-july-2019.pdf |format=PDF |title=Updating The Furniture and Furnishings (Fire) (Safety) Regulations 1988 - Government response to consultation |author=Office for Product Safety & Standards |publisher=Crown |date=July 2019 |accessdate=26 April 2023}}</ref> The regulations set out general testing requirements for foam fillings, non-foam fillings, composite fillings, and cover materials pass various material and combustion requirements.<ref name="BCNewUphol22">{{cite web |url=https://www.businesscompanion.info/en/quick-guides/product-safety/new-upholstered-furniture |title=New upholstered furniture |work=Business Companion |publisher=Chartered Trading Standards Institute |date=December 2022 |accessdate=26 April 2023}}</ref> Various updates have been made to the regulations over time. In 2019, the government, noting "growing evidence linking the specific flame-retardant chemicals most often used in furniture to serious long-term health impacts," acknowledged that updates to regulations on the materials used in furniture making were required, which would in turn further dictate manufacturing processes.
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| '''2.2.2.4 National Environment Protection (Used Packaging Materials) Measure 2011 - ''Australia'''''
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| In September 2011, Australia's National Environment Protection Council made law the National Environment Protection (Used Packaging Materials) Measure 2011. Signatories of the Covenant agreed to "a voluntary system of industry self regulation" to better ensure "improved environmental outcomes" in regards to packaging material use and re-use.<ref name="FRLNation11">{{cite web |url=https://www.legislation.gov.au/Details/F2011L02093 |title=National Environment Protection (Used Packaging Materials) Measure 2011 |work=Federal Register of Legislation |publisher=Australian Government |date=16 September 2011 |accessdate=26 April 2023}}</ref> However, a 2021 review found that the regulation was lacking in several areas, including with monitoring and enforcement. A December 2022 response by the government agreed, noting, "[l]ack of compliance monitoring and enforcement activity has undermined the effectiveness of, and confidence in, the mandatory co-regulatory arrangement and enabled some businesses to avoid their obligations." Updates to the regulations are expected by 2025, "to ensure that all packaging available in Australia is designed to be recovered, reused, recycled and reprocessed safely in line with circular economy principles. Reforming the regulation of packaging in Australia presents a significant opportunity to improve the way our packaging is designed ..."<ref name="DCCEEWAustr">{{cite web |url=https://www.dcceew.gov.au/environment/protection/waste/plastics-and-packaging/packaging-covenant |title=Australian Packaging Covenant |publisher=Department of Climate Change, Energy, and Environment and Water |date=2023 |accessdate=26 April 2023}}</ref> As this language suggests, such regulatory changes, should they come, will further dictate the materials designed and used in manufacturing processes in the country.
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| '''2.2.2.5 Surface Coating Materials Regulations (SOR/2016-193) - ''Canada'''''
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| Enacted in 2016, these regulations—enabled by Canada's Consumer Product Safety Act—dictate the amount of lead and mercury allowed in surface coating materials, stickers, and films under certain circumstances. The testing for those [[heavy metals]] must be done by manufacturers (or their third-party labs) "in accordance with a method that conforms to good laboratory practices."<ref name="JLWSurface22">{{cite web |url=https://laws-lois.justice.gc.ca/eng/regulations/SOR-2016-193/page-1.html |title=Surface Coating Materials Regulations |work=Justice Laws Website |publisher=Government of Canada |date=19 December 2022 |accessdate=26 April 2023}}</ref>
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| ====2.2.3 Pharmaceutical and medical devices====
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| '''2.2.3.x Current Good Manufacturing Practice (CGMP) regulations - ''United States and other countries'''''
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| For more on this, see the next section on other industries and regulations.
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| '''2.2.3.x Drugs and Cosmetics Act of 1940 - ''India'''''
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| This act represents the primary regulatory control over the manufacture of pharmaceuticals and cosmetics in India. The act "creates a web of regulatory authorities to govern the process at both the central and the state levels."<ref name="BasakIndian23">{{cite web |url=https://www.outlookindia.com/national/indian-pharma-irregularities-hint-at-lack-of-drug-regulation-policies-and-better-oversight-news-261625 |title=Indian Pharma Irregularities Point To Lack Of Drug Regulation Policies And Better Oversight |author=Basak, S. |work=Outlook |publisher=Outlook Publishing India Pvt. Ltd |date=13 February 2023 |accessdate=27 April 2023}}</ref> Like other pharmaceutical regulations in other countries, the act attempts to ensure that drugs, cosmetics, medical devices, and diagnostic devices sold in India are safe, standardized to a certain quality, and effective at what they are said to do. Public health activists, lawyers, and specialized agencies such as the WHO, however, have criticized India's regulatory efforts in recent years for not keeping up with the rapidly growing industry while exhibiting poor transparency, unnecessary complexity, and insufficient statutory backing (as seen with the Central Drugs Standard Control Organisation or CDSCO).<ref name="BasakIndian23" /><ref>{{Cite journal |last=Bhatt |first=Neha |date=2023-01-13 |title=Inconsistent drug regulation spells danger for India’s global pharma ambitions |url=https://www.bmj.com/lookup/doi/10.1136/bmj.p23 |journal=BMJ |language=en |pages=p23 |doi=10.1136/bmj.p23 |issn=1756-1833}}</ref> The country has been attempting to reform the regulatory system by, for example, updating the Indian Pharmacopoeia and the Drugs and Cosmetics Act with more modern, relevant information and improved labelling mechanisms for tracking and tracing drugs.<ref>{{Cite journal |last=Kukade, T.; Punnen, D.; Antani, M. |date=24 June 2022 |title=Mid-Year Regulatory Update 2022: Pharmaceuticals in India |url=https://www.natlawreview.com/article/mid-year-regulatory-update-2022-pharmaceuticals-india |journal=The National Law Review |volume=XII |issue=175}}</ref>
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| '''2.2.3.x Food and Drugs Act - ''Canada'''''
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| Canada's Food and Drugs Act enables its Food and Drug Regulations, which, among other things, helps to "ensure the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality."<ref name="HCDrug22">{{cite web |url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/legislation-guidelines.html |title=Drug products legislation and guidelines |author=Health Canada |publisher=Government of Canada |date=20 June 2022 |accessdate=27 April 2023}}</ref> Part C of the regulations addresses drugs in a broad sense, with Division 2 of that part regulating manufacturing controls, quality testing, and records management.<ref name="JLWFoodDrug23">{{cite web |url=https://lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html |title=Food and Drug Regulations (C.R.C., c. 870) |work=Justice Laws Website |publisher=Government of Canada |date=15 February 2023 |accessdate=27 April 2023}}</ref> These regulations are overseen and updated by Health Canada "through a combination of scientific review, monitoring, compliance, and enforcement activities."<ref>{{Cite book |url=https://publications.gc.ca/collections/collection_2012/bvg-oag/FA1-2011-2-4-eng.pdf |format=PDF |last=Office of the Auditor General of Canada |year=2011 |title=Report of the Auditor General of Canada to the House of Commons |chapter=Chapter 4: Regulating Pharmaceutical Drugs - Health Canada |publisher=Minister of Public Works and Government Services |pages=1–38 |isbn=9781100194028}}</ref>
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| '''2.2.3.x Pharmaceutical and Medical Device Act (PMD Act) - ''Japan'''''
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| The PMD Act represents one of the primary pieces of pharmaceutical and medical device regulation in Japan. The PMD Act replaced Japan's Pharmaceutical Affairs Law in November 2014, with the primary goal of using regulation to improve public health by assuring the quality, safety, and efficacy of pharmaceuticals, medical devices, and cosmetics, as well as preventing the expansion of activities harmful to those efforts. Under the PMD Act, manufacturers are expected to demonstrate how their products conform to Japan's regulations and how their operations are guided by a well-defined QMS.<ref name="JPMAPharm20">{{cite book |url=https://www.jpma.or.jp/english/about/parj/eki4g6000000784o-att/2020e_ch02.pdf |format=PDF |title=Pharmaceutical Administration and Regulations in Japan |chapter=Chapter 2: Pharmaceutical Laws and Regulations |author=Regulatory Information Task Force |publisher=Japan Pharmaceutical Manufacturers Association |pages=15–56 |year=2020 |accessdate=27 April 2023}}</ref><ref name="BSIJapan16">{{cite web |url=https://www.bsigroup.com/meddev/LocalFiles/en-US/Brochures/bsi-md-japan-brochure.pdf |format=PDF |title=Japan Pharmaceutical and Medical Device Act |publisher=BSI Group America, Inc |date=November 2016 |accessdate=27 April 2023}}</ref> The act has multiple chapters addressing the manufacturing of drugs, "quasi-drugs," cosmetics, cellular and tissue-based products, medical devices, and ''in vitro'' diagnostic devices, as well as separate chapters on the safety of and standards applicable to drugs.<ref name="JPMAPharm20" /> In regards to manufacturers of medical devices, they should turn to several sets of standards published by Japan's Ministry of Health, Labour and Welfare (MHLW)—MO No. 169 – ''Standards for Manufacturing Control and Quality Control for Medical Devices and In Vitro Diagnostic Reagents'' and MO No. 135 – ''Standards for Good Vigilance Practice (GVP)''—in order to better comply with the PMD Act.<ref name="BSIJapan16" />
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| ====2.3.4 Other industries and regulations====
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| Like standards, manufacturing regulations exist beyond industries such as the food and beverage and pharmaceutical industries. From electronics and automotive parts to cosmetics and chemicals, governments around the world place restrictions on and recommendations for testing a variety of manufactured goods. What follows are a few examples of regulations on other industries from various parts of the world.
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| '''2.3.4.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP) - ''United States and other countries'''''
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| As a broad concept, [[good manufacturing practice]] or GMP is an organized set of standards and guidelines that allow manufacturers of most any product to better ensure their products are consistently produced and packaged to a consistent level of quality. GMP tends to cover most every step of production, from planning recipes and choosing starting materials to training personnel and documenting processes.<ref name="ISPEGMP">{{cite web |url=https://ispe.org/initiatives/regulatory-resources/gmp |title=Good Manufacturing Practice (GMP) Resources |publisher=International Society for Pharmaceutical Engineering, Inc |accessdate=21 April 2023}}</ref> The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing<ref name="ISPEGMP" /><ref name="WHOMedicines15">{{cite web |url=https://www.who.int/news-room/questions-and-answers/item/medicines-good-manufacturing-processes |title=Medicines: Good manufacturing practices |publisher=World Health Organization |date=20 November 2015 |accessdate=21 April 2023}}</ref>, though it is applicable to most any other production industry.<ref name="CEReg07">{{cite web |url=https://www.controleng.com/articles/regulated-or-not-know-good-manufacturing-practices-gmp/ |title=Regulated or not? Know good manufacturing practices (GMP) |author=''Control Engineering'' Staff |work=Control Engineering |date=14 July 2007 |accessdate=21 April 2023}}</ref><ref name="FDAGMPCosm22">{{cite web |url=https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics |title=Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics |publisher=U.S. Food and Drug Administration |date=25 February 2022 |accessdate=21 April 2023}}</ref>
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| Closely related is the term "current good manufacturing practice" or cGMP. Both "GMP" and "cGMP" are largely interchangeable, though the latter is preferred in most regulatory language of the United States. A more nuanced take says that cGMP essentially represents the newest, most updated technologies implemented towards the goals of meeting GMP requirements.<ref name="PSDiff21">{{cite web |url=https://www.pharmaspecialists.com/2021/10/difference-between-gmp-and-cgmp.html#gsc.tab=0 |title=Difference Between GMP and cGMP |work=Pharma Specialists |date=13 October 2021 |accessdate=21 April 2023}}</ref><ref name="MoravekTheDiff">{{cite web |url=https://www.moravek.com/the-differences-between-gmp-and-cgmp/ |title=The Differences Between GMP and cGMP |work=Moravek Blog |publisher=Moravek, Inc |date=January 2021 |accessdate=21 April 2023}}</ref>
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| In the United States, cGMP—in the context of pharmaceuticals—is enshrined in numerous sections of Title 21 of the Code of Federal Regulations, including "in parts 1-99, 200-299, 300-499, 600-799, and 800-1299."<ref name="FDAcGMP22">{{cite web |url=https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations |title=Current Good Manufacturing Practice (CGMP) Regulations |author=U.S. Food and Drug Administration |date=16 November 2022 |accessdate=26 April 2023}}</ref> The FDA describes these regulations as containing "minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product."<ref name="FDAcGMP22" /> It also states safety, efficacy, and labeling requirements for manufactured drugs. These regulations require careful attention by manufacturers, lest they face seizure of their products, legal injunction, and criminal cases.<ref name="FDAFactsAb21">{{cite web |url=https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps |title=Facts About the Current Good Manufacturing Practices (cGMPs) |author=U.S. Food and Drug Administration |date=01 June 2021 |accessdate=26 April 2023}}</ref>
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| In the context of food, cGMP principles were first introduced in the U.S. in 1969 as 21 CFR Part 110, though the concept of cGMP was modernized in 2015, in 21 CFR Part 117. This led to not only broad food- and beverage-based cGMPs but also cGMPs specific to a type of ingestible, including dietary supplements, infant formula, low-acid canned food, and bottled water.<ref name="FDACurrentGood20">{{cite web |url=https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements |title=Current Good Manufacturing Practices (CGMPs) for Food and Dietary Supplements |publisher=U.S. Food and Drug Administration |date=31 January 2020 |accessdate=21 April 2023}}</ref>
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| GMP and cGMP contexts also exist for other manufacturing industries outside of pharmaceuticals and food, including automotive parts, medical devices, clothing, and more.<ref name="DomingoTheComp22">{{cite web |url=https://qvalon.com/blog/the-complete-guide-to-good-manufacturing-practices-gmp-by-qvalon/ |title=The Complete Guide to Good Manufacturing Practices (GMP) by QVALON |author=Domingo, J. |publisher=QVALON Inc |date=28 January 2022 |accessdate=21 April 2023}}</ref> Additionally, these concepts are not limited to the U.S. For example, the World Health Organization has its own GMP/cGMP guidelines for pharmaceuticals and biological medicines, with more than 100 countries reportedly incorporating those guidelines into their national medicine regulations.<ref name="WHOGMP18">{{cite web |url=https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/gmp |title=Health products policy and standards - Good Manufacturing Practices |publisher=World Health Organization |date=28 September 2018 |accessdate=26 April 2023}}</ref>
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| '''2.3.4.2 Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation - ''European Union'''''
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| For the E.U. chemical manufacturing and other manufacturing industries depending on those chemicals, REACH represents one of the most expansive and complicated pieces of regulation in the E.U. Affecting potentially more than 140,000 substances, manufacturers of those substances are now largely responsible for identifying hazards, identifying mitigation methods for those hazards, and managing associated risks. Of particular note are "substances of very high concern" (SVHCs) and how they are authorized and restricted. This regulations means manufacturers must pay closer attention to what substances get put into their products and report on SVHCs making up more than 0.1% (by weight) of the product. These regulations may also mean the manufacturer may need to redesign their products with new substances.<ref name="ECIAREACH21">{{cite web |url=https://www.ecianow.org/reach |title=REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) |publisher=Electronic Components Industry Association |date=2021 |accessdate=26 April 2023}}</ref>
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| '''2.3.4.3 Resolução de diretoria colegiada - RDC nº 529 - ''Brazil'''''
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| This Brazilian resolution, effective August 2021, revised the country's List of Prohibited Substances in Personal Hygiene, Cosmetics and Perfume Products to include additional substances. While it's not clear what original legislation houses that list, this list makes clear that manufacturers of personal hygiene, cosmetic, and perfume products have to be mindful of the ingredients they use in their manufacturing processes.<ref name="HavensBrazil21">{{cite web |url=https://www.ul.com/news/brazil-revises-list-prohibited-substances-cosmetics |title=Brazil Revises List of Prohibited Substances in Cosmetics |author=Havens, R. |work=UL Solutions |date=02 September 2021 |accessdate=26 April 2023}}</ref>
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| '''2.3.4.4 Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive - ''European Union'''''
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| The E.U. uses the RoHS Directive as a means towards restricting the use of specific hazardous materials in the manufacture of electrical and electronic equipment (EEE), namely "lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP)."<ref name="ECRestrict">{{cite web |url=https://environment.ec.europa.eu/topics/waste-and-recycling/rohs-directive_en |title=Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS) |publisher=European Commission |date=2023 |accessdate=26 April 2023}}</ref> By extension, the E.U. is encouraging safer alternatives for the manufacturing of EEE and fewer hazardous substances making their way into ecosystems from waste streams.
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| '''2.3.4.5 Road Vehicle Standards (RVS) legislation - ''Australia'''''
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| Coming into effect in July 2021 as a replacement to the Motor Vehicle Standards Act 1989, the RVS legislation brought regulation of road vehicle manufacturing into the twenty-first century, with updates to recalls, model reports, testing, and component type approvals. These regulations are backed by the Australian Design Rules (ADRs), which are national standards for vehicle safety.<ref name="DITRDCARoad23">{{cite web |url=https://www.infrastructure.gov.au/infrastructure-transport-vehicles/vehicles/road-vehicle-standards-laws |title=Road Vehicle Standards laws |author=Department of Infrastructure, Transport, Regional Development, Communications and the Arts |publisher=Australian Government |date=2023 |accessdate=26 April 2023}}</ref><ref name="DITRDCAusDes23">{{cite web |url=https://www.infrastructure.gov.au/infrastructure-transport-vehicles/vehicles/vehicle-design-regulation/australian-design-rules |title=Australian Design Rules |author=Department of Infrastructure, Transport, Regional Development, Communications and the Arts |publisher=Australian Government |date=2023 |accessdate=26 April 2023}}</ref> Approved testing facilities are required to test that vehicles and their components are in compliance with ADRs and other relevant standards.<ref name="DITRDCTesting23">{{cite web |url=https://www.infrastructure.gov.au/infrastructure-transport-vehicles/vehicles/rvs/testing-facilities |title=Testing facilities |author=Department of Infrastructure, Transport, Regional Development, Communications and the Arts |publisher=Australian Government |date=2023 |accessdate=26 April 2023}}</ref>
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| ==References== | | ==References== |
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