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Explore This IssueDecember/January 2017
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Laws governing the manufacture of foods and beverages have been in existence for thousands of years. In ancient civilizations, these laws were initially created to ensure fair trade practices through proper labeling and accurate declaration of weights and measures to prevent adulteration and for taxation purposes. Regulations governing the manufacture of beer can be traced back to the Code of Hammurabi, written in 1700 B.C. during the Babylonian era, and laws written to control the sale of wine and bread go back to the Roman Empire. During medieval times, the Assize of Bread and Ale was enacted in the 13th century to establish proper weights, quality standards, and prices of bread and beer sold in England. For example, each loaf of bread was required to be labeled with the baker’s indentification “mark” to regulate quality and ensure fair taxation. In 1215, the Magna Carta established standard measures for quantities of wine, corn, potatoes, and other goods to be sold or made available for sale in the English villages.
The American colonists also implemented food regulations soon after settling. In 1646, the General Court of Massachusetts Bay Colony enacted the Assize of Bread that was nearly an exact replica of the regulation established 400 years prior in Britain. The Massachusetts “Act Against Selling Unwholesome Provisions,” passed on March 8, 1785, is widely believed to be the first food safety law enacted by the fledgling U.S. government.
The beginnings of the U.S. regulatory agencies governing today’s food industries can be traced back to 1837 when Henry Leavitt Ellsworth was appointed the Commissioner of Patents, a position within the Department of State. Ellsworth sought to improve the country’s agricultural industry by widely distributing improved varieties of seeds. With the establishment of the Agricultural Department as a division of the U.S. Patent Office in 1839, Ellsworth became known as the “Father of the Department of Agriculture.” About 20 years later, President Lincoln established the independent USDA and appointed Isaac Newton as the agency’s first commissioner. In its early years, the agency was referred to as the “People’s Department” since it did not yet have Cabinet representation—this was not achieved until Feb. 9, 1889 when President Cleveland signed a bill finally elevating the USDA to Cabinet level.
The FDA, America’s oldest consumer protection agency, traces its origins to the USDA’s Division of Chemistry. In 1883, the agency appointed Harvey Wiley chief chemist who began investigating adulteration of pharmaceuticals and foods in the U.S. markets. Wiley and muckraking political activists worked tirelessly to raise awareness of hazards in these industries. Significant progress was made in 1905 when Upton Sinclair published “The Jungle,” a brutally honest novel that brought national attention to the horrific conditions in the Chicago meat packing industry at the time. Sinclair’s primary intention was to bring awareness of the poor working conditions of the immigrant workers. He stated change resulted “not because the public cared anything about the workers, but simply because the public did not want to eat tubercular beef.” Regardless, as a result of the public’s outcry, both the Federal Meat Inspection Act and the Pure Food and Drugs Act, also known as the Wiley Act, were signed on June 30, 1906 by President Roosevelt. These bills gave authority to the agencies in instituting mandatory inspection of meat-processing plants and to prohibit misbranded and adulterated food in interstate commerce. Two decades later, the Department of Chemistry was reorganized into a separate regulatory branch known as the Food, Drug, and Pesticide division and in 1930, the name was shortened to the Food and Drug Administration (FDA).
In 1938, the FDA was given more definitive jurisdiction over the food, drugs, and cosmetics industries when President Roosevelt signed the Federal Food, Drug, and Cosmetics Act. Replacing the Pure Food and Drugs Act, this body of law was initiated after the death of more than 100 patients from sulfanilamide medication that was adulterated with diethylene glycol. Since then, the bill has been amended several times and has broadened the agency’s jurisdiction to include oversight of medical devices, bottled water, and many other related industries.
Laws for Manufacturing Processes
The FDA proposed the regulations embodying the current Good Manufacturing Practices (cGMPs) in 1968 after several more decades of continued tragedies due to food safety incidents. The regulations were finalized in April of 1969 and were published as Part 128 of the Code of Federal Regulations. This was re-published as Part 110 of the CFR in 1977. The original cGMPs were written very generally and did not specify exactly what was required of facilities to comply with the regulations. The vagueness of the laws made them difficult for the agency to enforce, so the FDA improved the wording of the laws and published the revised version, 21 CFR 110, in 1986. Industry-specific GMPs were also included in 21 CFR Parts 100 through 169 for infant formula, thermally processed low-acid canned foods, acidified foods, and bottled drinking water.
During the late 1950s, NASA and Pillsbury food engineers and scientists created a revolutionary approach to food safety that built quality into the product with the intent of ensuring the utmost safety of the food for the manned space program. This concept evolved into what we now know as HACCP: Hazard Analysis and Critical Control Points. In 1971, the concept was presented by Pillsbury at the National Conference on Food Protection, which was co-sponsored by the FDA and the American Public Health Association. In 1974, the FDA incorporated the concepts of HACCP into its low-acid and acidified food regulations as a response to outbreaks of Clostridium botulinum poisonings in commercially-canned food. Since the FDA implemented HACCP, these outbreaks have virtually been eliminated. The public outcry for safer meat products was voiced again in 1993 after an outbreak of E. coli O157:H7 in undercooked meat patties, resulting in four deaths and over 400 illnesses. The USDA-FSIS began to investigate the benefits of HACCP’s scientific approach to food safety versus the method of sensory inspection that was then employed by onsite USDA inspectors. As a result, the USDA enacted the Pathogen Reduction/HACCP Systems ruling on July 25, 1996. The laws focus on preventing and reducing microbiological pathogens in raw products that can cause illness. The regulations also clarify the roles and responsibilities of industry and government for producing and ensuring safe foods. As a result of the widespread implementation of HACCP, the CDC formally recognized the HACCP’s approach to food safety as an important factor in the overall decline of bacterial foodborne illnesses.
Food Safety Today
In the 1990s, consumer confidence in the food industry’s ability to supply safe food continued to be low after high-profile debacles such as Great Britain’s BSE outbreak, the U.S.’s E. coli 0157:H7 outbreak, and Belgian’s Dioxin Affair. CEOs from major food retailers around the world addressed the concerns by establishing the business-driven Global Food Safety Initiative (GFSI) in May 2000. The group, comprised of food safety experts in food manufacturing, retail, food service, academia, and government, collaborated to create a standardized set of requirements designed to ensure safe food supplies worldwide. These requirements are contained in the GFSI’s Guidance Document that was published in August of 2001. GFSI stakeholders formally accepted select food safety management schemes that met the Guidance Document’s requirements in June of 2007. Today, food manufacturing facilities strive to achieve GFSI certification through independent third-party audits conducted against requirements in the scheme of their choice. Although GFSI does not have regulatory authority over the food manufacturing industry, it does have tremendous financial influence, and facilities reap the economic benefits of certification to these globally recognized standards.
The FDA’s Food Safety Modernization Act (FSMA) is the most modern body of legislation governing the U.S. food industry. FSMA is the agency’s first major regulatory overhaul in 70 years and was signed into law by President Obama on Jan. 4, 2011. Much like HACCP, these regulations completely revamp the FDA’s approach to food safety by changing the focus from reaction to prevention. The law requires facilities to 1) develop documented food safety plans, called Hazard Analysis and Risk-Based Preventive Controls, which identify all potential hazards associated with the process or product, 2) implement risk-based preventive control measures that minimize or prevent the identified hazards, and 3) describe the methods of prevention. The law also updates the cGMPs, clarifies the definition of “farm,” and mandates specific preventive control programs for production processes, food allergens, sanitation controls, supply chain controls, and recall plans.
Additional information on the specific requirements for preventive controls and the modernization of the cGMPs will be discussed in the second and third articles in this series.
Thoma, a food safety and quality professional with nearly 20 years of experience in food manufacturing and food safety auditing, has worked for NSF International for four years as both a GFSI certified auditor and as a technical specialist in the Supply Chain Food Safety group. Reach her at email@example.com.