On November 7, 2013 the non-profit organization The Pew Charitable Trusts (Pew) published a summary report of its food additive project. The project, which was conducted between 2010 and 2013, found two systemic problems in the U.S. food additive regulation leading to the unsafe use of food additives, including indirect food additives used in food contact materials (FCMs). The first problem, according to Pew, is the generally recognized as safe (GRAS) determination process, which results in the uncontrolled use of an estimated 1000 chemicals by companies. Secondly, Pew attested the U.S. Food and Drug Administration (FDA) a lack of authority required to obtain the necessary information to identify chemicals of concern already in use, set priorities for their evaluation, and review their safety. As a result of these two issues 3000 of the around 10 000 food additives in use have not been evaluated for their safety by the agency. Further Pew points out, that the chemical evaluations which are carried out by the FDA employ outdated science and that the Food Contact Notifications program introduced in 1997 lacks transparency. Pew alerts to the fact that chemicals “causing health problems short of immediate serious injury” are unlikely to be detected by the FDA.

In its newly published summary report, Pew proposes to the U.S. Congress to update the Food Additive Amendment of 1958 and specifies four primary recommendations. Firstly, Pew suggests limiting GRAS exemptions. Secondly, they recommend modernizing FDA’s science to include behavioral effects, endocrine systems, subpopulations, thresholds, absorption, distribution, metabolism and excretion (ADME) data, consistency across substances and weight of evidence. Thirdly, Pew stresses the importance of ensuring that chemicals already in use are safe, and fourthly, suggests establishing a fee-based funding program to pay for the review process. The updates should ensure that FDA approves all first uses of new chemicals, reviews new uses, streamlines its decision-making process to be more timely and efficient, upgrades its science and independence to determine safety and uses scientific tools and data for priority setting in safety assessments of chemicals already on the market.

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The Pew Charitable Trusts (November 7, 2013). “Fixing the Oversight of Chemicals added to our Food.