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Environmental Factor

May 2011

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NIEHS leaders help shape regulatory policy

By Thaddeus Schug
May 2011

NIEHS/NTP Director Linda Birnbaum, Ph.D.

Birnbaum noted that GLP alone does not guarantee a good study or that the right question was asked. "Make sure that the best available science is utilized and incorporated in our understanding of risk," said Birnbaum. (Photo Courtesy of the Pew Health Group)

Ray Tice, Ph.D.

Tice presented an overview of role that the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) plays in developing regulatory policy. (Photo Courtesy of the Pew Health Group)

Michael Taylor, J.D., Deputy Commissioner for Foods at FDA

Michael Taylor, J.D., Deputy Commissioner for Foods at FDA, reviewed the complicated regulatory process applied to food additives. (Photo Courtesy of the Pew Health Group)

Maricel Maffini, Ph.D.

Event organizer Maricel Maffini, Ph.D., senior officer of the Food Additives Campaign at Pew Health Group, listens in on one of several discussion sessions. (Photo Courtesy of the Pew Health Group)

Pew Conference Center main conference room

The meeting included a well-balanced mix of scientists representing industry, academia, and government agencies. Shown here is the main conference room within the newly renovated Pew Conference Center located in Washington, D.C. (Photo Courtesy of the Pew Health Group)

Most Americans spend a large portion of their food budget on processed foods, which, unlike whole foods, contain additives. These substances are meant to affect the characteristics of food, such as preserve it, or alter the color or the way it tastes. Packaging may also be considered an indirect food additive, if it adds a substance to the food. The question is, are these additives safe? And, what scientific evidence should be considered when determining food safety?

Against that backdrop, NIEHS/NTP leaders joined experts from government, industry, academia, and public interest organizations to participate in a workshop titled "Enhancing FDA's Evaluation of Science to Ensure Chemicals Added to Human Food Are Safe," held April 5-6 at the Pew Conference Center in Washington, D.C. The workshop was co-sponsored by the U.S. Food and Drug Administration (FDA), the Institute of Food Technologists (IFT), the journal Nature, and the Pew Health Group.

The goal of the meeting was to develop a better understanding of the current system FDA uses to assess the safety of chemicals added to human food, and to explore opportunities to improve the use of all scientific studies, both industry-backed and hypothesis-driven, in FDA's risk assessment decision making.

NIEHS/NTP Director Linda Birnbaum, Ph.D., headed the NIEHS/NTP delegation, which included Division of Extramural Research and Training (DERT) Program Administrator Jerry Heindel, Ph.D., and Ray Tice, Ph.D., chief of the NTP Biomolecular Screening Branch and High-Throughput Screening Initiative coordinator.

In her opening remarks to the group, Birnbaum explained that many of the programs sponsored by NIEHS - NTP studies and initiatives, along with intramural and extramural research -"provide valuable scientific information that should be used by FDA to shape regulatory policy." She said, "Understanding the hazards and risks that chemicals pose to biological systems can be incredibly complicated, and, therefore, it is imperative that all available data be incorporated into the regulatory framework."

Food additive regulation

The FDA is tasked with regulating food additives and has developed guidelines for testing protocols that should be met by manufacturers before products are deemed safe. Traditionally these studies have been performed by industry-funded contracting labs under conditions referred to as good laboratory practice (GLP).

However, in the past few years, controversy has emerged regarding the safety of several food additives, such as BPA, which is contained in the linings of plastic bottles and canned foods. Many researchers maintain that current guideline-based studies are not sufficient to capture all adverse human health effects.

The workshop was divided into mediated sessions, in order to focus, facilitate, and identify solutions in four contentious areas: identifying and validating relevant endpoints, evaluating study design and data for regulatory decisions, developing and reviewing test guidelines, and identifying and evaluating solutions.

The Pew Health Group ( Exit NIEHS plans to use feedback from each discussion session to develop recommendations for regulators and others to consider when evaluating food safety. The group will publish a proceeding of the workshop in a peer-reviewed scientific journal.

(Thaddeus Schug, Ph.D., is a postdoctoral research fellow in the NIEHS Laboratory of Signal Transduction and a regular contributor to the Environmental Factor. He is currently on detail as a program analyst in the NIEHS Division of Extramural Research and Training.)


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