Food and Drug Administration

The federal agency whose work this book focuses on is the Food and Drug Administration. The FDA touches the lives of virtually every American every day. It is the FDA’s job to see that the food we eat is safe and wholesome, the cosmetics we use won’t hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products such as microwave ovens won’t do us harm. Food and drugs for pets and farm animals also come under FDA scrutiny. The FDA also ensures that all of these products are labeled truthfully with the information that people need to use them properly.

The FDA is one of our nation’s oldest consumer protection agencies. Its approximately 9,000 employees monitor the manufacture, import, transport, storage and sale of about $1 trillion worth of products each year. It does that at a cost to the
taxpayer of about $3 per person.

First and foremost, the FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug and Cosmetic Act and several related public health laws. To carry out this mandate of consumer protection, the FDA has some 1,100 investigators and inspectors who cover the country’s almost 95,000 FDA-regulated businesses. These employees are located in district and local offices in 157 cities across the country.

These investigators and inspectors visit more than 15,000 facilities a year, seeing that products are made right and labeled truthfully. As part of their inspections, they collect about 80,000 domestic and imported product samples for examination by FDA scientists or for label checks.

If a company is found violating any of the laws that the FDA enforces, the FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. A recall is generally the fastest and most effective way to protect the public from an unsafe product.

When a company can’t or won’t correct a public health problem with one of its products voluntarily, the FDA has legal sanctions it can bring to bear. The agency can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties—including prison sentences—are sought against manufacturers and distributors.

About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. In addition, about 30,000 import shipments a year are detained at the port of entry because the goods appear to be unacceptable.

The FDA publishes the Food Code, a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. Local, state, tribal and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy. The FDA’s Food Code is intended to help state health
departments develop regulations for a food service inspection program. The Food Code is not actual law, it is basically the FDA’s advice on how to regulate the food system to ensure safety. Some states may adopt the Code in its entirety and others may just use it as a basis for their own code.

It also serves as a reference of best practices for the retail and food service industries (restaurants, grocery stores and institutions such as nursing homes) on how to prevent food-borne illness. Many of the over one million retail and food service establishments apply Food Code provisions to their own operations.

Between 1993 and 2001, the Food Code was issued, in its current format, every two years. With the support of the Conference for Food Protection, the FDA has decided to move to a four-year interval between complete Food Code revisions.

The next complete revision of the Food Code will be published in 2005. During the four-year interim period, a Food Code Supplement that updates, modifies or clarifies certain provisions is being made available.

The main areas on which the Food Code focuses are:

• Food handling and food preparation.
• Personnel.
• Equipment and utensils.
• Cleaning and sanitizing.
• Services (water, sewage, plumbing, waste disposal and pest management).
• Construction and maintenance.
• Compliance procedures.

The Food Code addresses controls for risk factors and establishes five key public health interventions to protect consumer health. Specifically, these interventions are:

• Demonstration of knowledge.
• Employee health controls.
• Controlling hands as a vehicle of contamination.
• Time and temperature parameters for controlling pathogens.
• Consumer advisory.

Consider also the following characteristics that retail food establishments share.

The industry has a wide range of employee resources, from highly trained executive chefs to entry-level front-line employees. Employees may have a broad range of educational levels and communication skills. It may be difficult to conduct in-house training and to maintain a trained staff because employees may speak different languages or there may be high employee turnover.

Many establishments are start-up businesses operating without benefit of a large corporate support structure and having a relatively low profit margin and perhaps less capital to work with than other segments of the food industry.

There is an almost endless number of production techniques, products, menu items and ingredients used. Suppliers, ingredients, menu items or specifications may change frequently.