Science-based tools for public policy development are critical

Suzanne S. Harris, Executive Director,
March 27, 2013

I am responding on behalf of the International Life Sciences Institute (ILSI) to the Commentary published on Online First on 8 March 2013: "Conflicts of interest at the European Food Safety Authority erode public confidence" by Robinson et al.

In their Commentary, the authors raise questions about practical scientific tools being studied by a variety of private and public sector groups, including the European Food Safety Authority (EFSA). EFSA has previously and thoroughly responded to the questions posed by the authors on plant biotechnology; the Threshold of Toxicological Concern (TTC) concept; and scientific integrity.(1) My goal is to address the specific section of the Commentary under the heading "EFSA Promotes Industry Concept to Assess Chemicals Risk" by providing additional context on TTC as a risk assessment tool.

The concept underlying TTC was initially proposed in 1967(2) and formally articulated by the US Food and Drug Administration in 1986(3). It was developed to identify, characterize, and prioritize risk when data on substances of concern were extremely limited or nonexistent. As the authors state, ILSI has supported a number of activities designed to test the validity of the TTC approach since then, and we have worked with industry and public partners to hone the tool as more data becomes available.

We encourage JECH readers to learn more about the TTC concept by reading the report "The Threshold of Toxicological Concern (TTC) concept: Development and regulatory applications."(4) This document, produced by the Danish Ministry of the Environment, Environmental Protection Agency and available in English, provides an extremely comprehensive, detailed, and readable review of the TTC concept's scientific principles; its development over the years; its current uses; and its strengths and weaknesses.

ILSI's actions on TTC have been with the primary goal to help improve response to safety assessment needs in situations when it is analytically difficult to identify a substance or when an assessment is needed urgently and existing data are insufficient. We fully recognize TTC is not a blanket solution and our own publications describe its limitations.(5) However, to diminish well-studied, scientifically supported tools that can be used to safeguard human health is both inappropriate and irresponsible.

1 EFSA Answers Back. Online Q&A. http://www.efsa.europa.eu/en/news/efsaanswersback.htm

2 Frawley JP (1967). Scientific evidence and common sense as a basis for food packaging regulations. Fd Cosmet Toxicol 5, 293-308.

3 Rulis AM (1986). De minimis and the threshold of regulation. In: Felix CW (Ed.) Food Protection Technology. Lewis Publishers Inc., Chelsea, Michigan, 29-37.

4 Nielsen E and Larsen JC (2011). The Threshold of Toxicological Concern (TTC) concept: Development and regulatory applications. Danish Ministry of the Environment, Environmental Protection Agency. Environmental Project No. 1359 2011. This report can be downloaded at http://www2.mst.dk/udgiv/publications/2011/03/978-87-92708-86-1.pdf online.]

5 Koster S et al. (2011). Application of the TTC concept to unknown substances found in analysis of foods . Food Chem. Toxicol. 1643 - 1660.

Conflict of Interest:

I am employed by the International Life Sciences Institute, which is primarily funded by the food, drug, and agriculture industries.

Conflict of Interest

None declared