Pew Workshop Examines the FDA's Approach to Ensuring Food Contains Safe Levels of Added Chemicals

“How much is too much?” That was the fundamental question at the heart of a November 2011 workshop hosted by The Pew Charitable Trusts, the Institute of Food Technologists (IFT) and the journal Nature.   

The workshop proceedings are available in the online version of the January 2013 edition of Comprehensive Reviews in Food Science and Food Safety.

Introduction

More than 70 stakeholders examined how the U.S. Food and Drug Administration (FDA) ensures that people are exposed to safe levels of chemicals in food.The proceedings, published in the January 2013 issue of the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety, lay out participants’ perspectives for enhancing the FDA’s methods.

Currently, the FDA makes two key calculations when determining the levels at which chemicals added to food are safe: First, how much is safe to eat? Second, how much of that chemical will people consume? Typically, a chemical is considered to be safe if the amount people eat is less than the amount that may cause health problems.

While consensus was not the goal of the workshop, attendees generally agreed that a framework for more extensive surveillance of additives on the market and for reassessment of prior safety decisions could enhance the FDA’s efforts to ensure that chemicals in food are safe.

There was also general agreement among participants in the following four areas:

1. Food consumption data should incorporate longer-term surveys of people’s eating patterns. Today, the FDA typically relies on food consumption data that provide detailed information on what and how much food thousands of people consume by asking them to recall everything they ate over a two-day period. Conducting 14-day surveys could provide more representative estimates of less frequently-consumed foods or nutrients.
2. Children and pregnant women should be more rigorously evaluated in safety assessments. Before an additive is allowed in food, safety assessors typically take into account exposure for two groups: (1) children between the ages of two and five and (2) the general population (anyone over two-years-old) who eat food containing the additive.  The FDA should take more subpopulations into account—in particular, children and pregnant women at more precisely defined stages of development.
3. The cumulative effects from all dietary sources should be considered in a consistent manner. The agency should broaden its dietary exposure assessments to include any additive present in tap water, consumed in dietary supplements or also used as pesticides on food.
4. Interagency coordination should be more robust. Currently many aspects of gathering data and assessing exposure are spread among federal agencies, especially the FDA and the U.S. Environmental Protection Agency (EPA). The FDA should increase communication, collaboration and exchange of scientific information through regular interagency meetings with the EPA and other agencies.

Recommendations

Based on the workshop discussions, Pew developed the following five recommendations for enhancing chemical safety in food:

1. The FDA should examine the cumulative effects of additives in food whenever they have similar chemical structures or produce similar effects in people.
2. When estimating exposure, the FDA should evaluate all dietary sources—not just the ones they regulate as additives. These exposure levels should be incorporated into the overall safety assessment for a more accurate picture of how the combined sources may affect human health.
3. The FDA should increase post-market monitoring and place greater priority on identifying and reassessing an additive on the market if its use has increased significantly or scientific evidence indicates it may cause harm.
4. When assessing the safety of an additive, the FDA should consider eating habits of children and pregnant women more consistently and precisely.
5. The FDA should modify its current approach to ensure that at least 95 percent of consumers who may be exposed to a chemical, rather than 90 percent, are protected. This would safeguard millions of Americans who may not be covered under the FDA’s standard.

For more information, please contact Juli Putnam at 202-540-6805 or jputnam@pewtrusts.org.

Related: See proceedings from the April 2011 workshop, Enhancing FDA's Evaluation of Science to Ensure Chemicals Added to Human Food Are Safe (subscription required).  

The Pew Charitable Trusts’ Food Additives Project

In 2010, The Pew Charitable Trusts launched the Food Additives Project. Its purposes are to: 1) conduct a comprehensive analysis of the existing regulatory program; 2) determine whether that system ensures that chemicals added to food are safe as required by law; and 3) develop policy recommendations. Through a transparent process that engages industry, academic, government, and public interest stakeholders, project staff consults with its team of expert advisors, holds workshops and publishes peer-reviewed journal articles.

For more information on The Pew Charitable Trusts’ Food Additives Project, visit www.PewHealth.org/FoodAdditives.