Re-Evaluating Additives on the GRAS List

However, BVO exposure is not limited to diet. Bromine atoms slow down chemical reactions that cause a fire thereby slowing down the spread of flames. Consequently, they are used in flame retardants that are added to polystyrene foam cushions, children’s products, and plastics used in electronics. Research in animals and humans has shown that bromide is building up in tissue and breast milk, and it has been linked to impaired neurological development, reduced fertility, and early puberty.

What Makes a Substance Safe?

So how does the FDA define safe in a food ingredient? There are two calculations the agency uses to evaluate the potential toxicity of an additive. The first is the Acceptable Daily Intake (ADI), derived from a review of the substance’s clinical nature and available toxicology studies, plus relevant safety factors. It is an estimate of the maximum amount of a substance that a person can consume daily over their lifetime without significant risk of harm. The other consideration is Estimated Daily Intake (EDI), the predicted dietary exposure based on how often a person consumes the ingredient in any food on a typical day, the size of the portion, and how much of ingredient is found in the foods.

Simply put, if the EDI is less than the ADI, the ingredient can indeed be considered safe.

This safety equation is simple, but gathering accurate dietary exposure information to assess EDI is not. For the daunting task of determining exactly what and just how much Americans eat, the FDA relies primarily on the National Health and Nutrition Examination Survey (NHANES), conducted by the Centers for Disease Control and Prevention (CDC). This survey asks thousands of participants to recall everything they ate over a two-day period. From these answers, an overall view of American eating habits can be extrapolated.

Some experts, however, feel that two days provides an insufficient sample of eating habits, and asking consumers to recall everything they ate for a period of time in the past leaves a large margin of error. So the FDA also relies on surveys conducted by private firms. These studies last 14 days and often use daily food diaries kept by participants. To further inform their EDI estimates, the agency uses data reporting how much of certain commodities enter the marketplace annually, tests to monitor chemicals and pesticides as well as nutrient elements in foods and biomonitoring data from blood and urine specimens from randomly selected NHANES participants.

How do New Ingredients Make GRAS List?

But since 1997, the FDA’s GRAS determinations have not involved testing by the agency’s staff. Rather, the fact gathering and proof have been left up to the private sector, usually to companies looking to market a new product with a new additive. The GRAS Notification Program is a voluntary process by which an individual can inform the FDA that a substance used in a particular product is GRAS. A notification, sent to the FDA’s Office of Food Additives, includes:

• A brief description of the substance
• The intended use of the substance
• The basis for the GRAS determination

The notification should include information about the chemical and toxicological properties of the substance and any data that would not support a GRAS determination. Finally, the notifier must explain why, in light of the totality of the information, they have concluded that the substance should be GRAS.

When is a Second Look in Order?

In November 2011, The Pew Charitable Trusts, the Institute of Food Technology (IFT), and the journal Nature cosponsored the workshop Perspectives on FDA’s Exposure Assessment to Ensure Substances Added to Human Food Are Safe. The event brought together more than 70 experts from academia, industry, government, and public interest groups who agreed that the FDA’s current system for monitoring food safety has room for improvement.