The workshop, co sponsored by Nature journal, the Institute of Food Technologists (IFT), and the Pew Heath Group, brought together more than 80 scientists and and policymakers to develop a shared understanding of the current system FDA uses to assess the hazards of chemicals added to human food and explore opportunities to strengthen that system.
CONSIDERATIONS IN IDENTIFYING AND VALIDATING ENDPOINTS, INCLUDING ADVERSE EFFECTS
Round 1 of the small group discussions will focus on considerations in identifying and validating relevant endpoints, including adverse effects. In essence, we are asking the following question: What should guideline-based, nonclinical studies measure to assess the human health effects of a substance?
To help focus the discussion, we selected four hot topics designed to engage participants. They are
At first glance, you may notice that not all of these topics involve health effects. We have included an array of relevant topics, including health effects, characterization of a class of materials that may raise unique hazards, and methods used to screen for markers of exposure to highlight different aspects of the issue.
The discussion of endocrine disruption and behavioral impacts will focus on the contentious issue of whether or not endpoints with positive results in hypothesis-based research constitute or sufficiently predict adverse effects to justify incorporation into guideline-based studies. We selected these two topics because they represent distinct aspects of endpoint identification and validation and would allow us to address the underlying questions. Note that FDA does not have a definition of adverse effect related to chemicals added to food.
The discussion on nanomaterial characterization will look at a different issue: What is the substance being studied? Currently, guideline-based studies do not assess whether or how much of a substance is between 1 and 100 nanometers in a single dimension. Recent research into these nanoscale materials indicates that some substances exhibit unusual physical and chemical properties that may be important toxicologically.
The Tox21 and NHANES discussion will focus on the use of these screening tests as a trigger for more focused hypothesis-based research and, perhaps, guideline-based studies. Tox21 screens use in vitro methods to evaluate the impact of a wide array of chemicals and mixtures on cells. NHANES screens for human exposures by measuring chemicals in a large sample of the general population. In other words, Tox21 is a screen for a substance’s potential hazard, and NHANES is a screen for human exposure. Both methods are important to understand the potential health risk posed by a substance. While a positive result in either screening system does not mean the result is an adverse effect, it does indicate the need for additional study that will lead to regulatory decisions.
By examining all three types of issues—adverse health effects, raw material characteristics and results of screening methods to conduct additional studies to identify adverse effects—we can ensure that nonclinical, guideline-based studies are more adequately designed and are more useful and relevant to human health.
Read Full Section: Small Group Discussion Round 1 (PDF)
A recent article by Pew experts concludes that the science the U.S. Food and Drug Administration (FDA) uses to assess the safety of food additives has not kept pace with recent scientific developments, and the agency should review and retool its approach to making decisions about the safety of chemicals used in food and packaging in the United States.
More info"Amid growing public concern over the safety of additives in products ranging from caffeinated energy drinks to industrial chemicals in food containers and water bottles, the U.S. Food and Drug Administration is under pressure to reexamine its rules, and there are signs it may do so."
More infoThe complexity of our food supply and the oversight of its safety raise fundamental questions about what we eat — some of which were answered for the first time in "Navigating the U.S. Food Additive Regulatory Program," an analysis undertaken by Pew and published in the peer-reviewed journal, Comprehensive Reviews in Food Science and Food Safety. The following "frequently asked questions" summarize the findings and conclusions of this article.
More infoFrom oil in Gatorade to the amount of caffeine and other stimulants in energy drinks and the so-called "pink slime" found in beef, previously unnoticed ingredients are coming under scrutiny as health-conscious consumers demand more information about what they eat and drink, and sometimes go public via social networking and the Internet.
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