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.
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Explore This IssueDecember/January 2017
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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.