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2. Standards and regulations affecting food and beverage labs

Societies around the world have grown to expect and depend on high-quality, nutritious foods and beverages, whether coming directly from a farm or being produced by a food and beverage manufacturer. With the history of food and beverage safety having a somewhat checkered past until the early twentieth century, this expectation hasn't always been easy to meet. However, with better understanding of food safety and greater efforts to standardize and regulate it, governments and producers have improved food quality and safety into the twenty-first century. Yet any assurances coming from these efforts to standardize and regulate are dependent upon rigorous and validated methods not only in the production facility but also in any laboratory making analyses for the facility.

This chapter will briefly examine the standards, regulations, guidance, and other factors globally driven by not only the demand for safer foods and beverages, but also that in many cases dictate what and how quality activities are conducted towards ensuring food safety around the world inside and outside the food and beverage laboratory.

2.1 Globally recognized food safety standards

Like other industries, the food and beverage industry depends on well-defined and -justified standards to better ensure the quality of their products. Implementing and maintaining conformance to internationally recognized and benchmarked food safety standards benefits the food and beverage organization in a number of ways:

• 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.
• 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.
• 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.
• It drives organizations to better vet their suppliers and service providers for meeting required food safety management practices.
• It enables organizations to better demonstrate auditable compliance with modern food safety management practices.
• It allows organizations to limit product recalls, reduce customer complaints, and better protect their brand.

As such, 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.

2.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)

In 1998, the 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. The standard is implemented by an organization through gap assessment, documentation development, consultation and assessment, internal auditing, and resolving non-conformances to the standard.

2.1.2 Codex Alimentarius

The 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). 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." 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. It's not unusual for governments to approach the FAO seeking help with harmonizing national legal frameworks of food safety with the Codex Alimentarius. Among the Codex, some of the more broadly useful standards include General Principles of Food Hygiene (CXC 1-1969), General Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995), and General Methods of Analysis for Contaminants (CXS 228-2001).

2.1.3 Global Food Safety Initiative (GFSI)

The 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. Previously known as the GFSI Guidance Document, 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." 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. GFSI is also responsible for ensuring CPOs and certification bodies meet the necessary requirements.

2.1.4 Hazard analysis and critical control points (HACCP)

The hazard analysis and critical control points or HACCP system has been adopted and integrated in various ways over the years, 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. 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. HACCP also found its way into other standards benchmarked by the GFSI. The concept of HACCP has perhaps changed slightly over the years, but the main principles remain:

1. Conduct a hazard analysis.
2. Identify CCPs.
3. Establish critical limits for those CCPs.
4. Establish monitoring procedures for those CCPs.
5. Establish corrective action for failed limits.
6. Establish verification procedures.
7. Establish record keeping and documentation procedures.

2.1.5 International Featured Standards (IFS)

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" or "uniform evaluation system" 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).

2.1.6 International Organization for Standardization (ISO) 22000

The 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. ISO 22000 is based off the ISO 9000 family of quality management system standards and, like other standards, incorporates elements of HACCP. 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. Major standards applicable to manufacturers with laboratories include:

• ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing
• ISO/TS 22002-4:2013 Prerequisite programmes on food safety — Part 4: Food packaging manufacturing
• ISO/TS 22002-6:2016 Prerequisite programmes on food safety — Part 6: Feed and animal food production

2.1.8 Safe Quality Food (SQF) Program

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. 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. Like other standards, the organization wanting to be accredited finds a certified third-party auditor to administer program certification.

2.2 Regulations and laws around the world

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 FAQ 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, which should not be surprising given the cultural, political, and functional differences across regions and nations of the world.

2.2.1 Food Safety Act 1990 and Food Standards Act 1999 - United Kingdom

The Food Safety Act of 1990 and 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. 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. 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." 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. 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.

2.2.2 Food Safety and Standards Act of 2006 - India

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. 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. 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.

2.2.3 Food Safety Law - China

The Food Safety Law is described as "the fundamental law regulating food safety in China." 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." Among these activities, the Law describes how food testing laboratories shall conduct their activities, from accreditation and sampling to testing and reporting.

2.2.4 Food Sanitation Act and Food Safety Basic Act - Japan

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." 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. 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.

2.2.5 Food Safety Modernization Act (FSMA) and other acts - United States

The 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. It has been described by the FDA as "the most sweeping reform of our food safety laws in more than 70 years." 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. 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 LAAF Rule).

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. The FSIS has developed its own regulatory requirements for meat, poultry, and egg products, including for inspections, imports and exports, labeling, and laboratory testing.

2.2.6 General Food Law Regulation (GFLR) - European Union

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. 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. As such, the EFSA develops broad and sector-specific guidance, 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. 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."

2.2.7 Safe Food for Canadians Act (SFCA) - Canada

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." Though Canadian Food Inspection Agency (CFIA) enforcement of the SFCA's regulations didn't start until January 2019, 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. 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.

2.3 Other influencing factors

Several other organized efforts towards better food quality are worth mentioning, often influencing the development of standards and regulations of other entities around the world.

2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)

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. The concept of GMP is often spoken of in terms of pharmaceutical and medical device manufacturing, though it is applicable to most any other production industry, including the food and beverage industry.

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. In the United States, cGMP—in the context of food—was first introduced 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.

2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)

The WHO's Nutrition and Food Safety (NFS) Department envisions "a world free from all forms of malnutrition and foodborne diseases, within safe and supportive societies and healthy environments." One way they attempt to make that vision a reality is through its SSA Unit, described as "the focal point for WHO’s work on international standard-setting in food safety and nutrition." The SSA consists of a number of committees that develop scientific risk assessments and guidelines, which in turn make their way into the Codex Alimentarius and other national regulations and standards. These assessments and guidelines cover a variety of topics, including microbiological risk management, drug residues, food contaminates and additives, microplastics, and allergens, among others.