Data gaps in toxicity testing of chemicals allowed in food in the United States

Neltner, Thomas G.; Alger, Heather M.; Leonard, Jack E.; Maffini, Maricel V.

doi:10.1016/j.reprotox.2013.07.023

Cited by 79 publications

(50 citation statements)

References 8 publications

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“…The FDA held a public meeting in December 2014 and collected public comments with a deadline in 2015, but there is no public information on further progress. The GMA launched a Code of Practice in October 2014 11 , corresponding to the modernizing initiative, which includes five points 12 : Neltner et al (2013a) above.…”

Section: Summarize: "The So-called 'Gras Exemption' To the Statutory mentioning

confidence: 99%

“…The critical aspect is the public availability of data. To quote the FDA guidance for industry 44 : "The difference between the criteria for eligibility for classification as GRAS through scientific procedures (21 CFR 170.30(b) and 21 CFR 570.30(b) Earlier studies have identified deficits in this public availability (Neltner et al, 2013a), as discussed above. However, as most findings will be negative, such publication in the scientific literature is often difficult.…”

Section: Revising Earlier Gras Evaluationsmentioning

confidence: 99%

“…However, an enormous number of chemicals are added either directly or indirectly (as contaminants such as pesticides or contact materials) to US food. And many of these have no (public) data as to their safety; Neltner et al (2013a) report that "Less than 38% of FDA-regulated additives have a published feeding study. For chemicals directly added to food, 21.6% have feeding studies necessary to estimate a safe level of exposure and 6.7% have reproductive or developmental toxicity data in FDA's database".…”

mentioning

confidence: 99%

“…As summarized by Neltner et al (2013a): "By law, food additives cannot be used in food without an affirmative determination that their use is safe (21 U.S.C. §321 and §348) by FDA or, in some cases, the additive manufacturer.…”

mentioning

confidence: 99%

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Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Hartung

2018

ALTEX

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SummaryThe US Food and Drug Administration (FDA) has premarket review authority over food additives, but a food manufacturer may, according to the legislation, intentionally add a substance to human food or animal food without their premarket review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use. Generally recognized as safe (GRAS) implies that the current scientific community agrees on the adequacy of how data is generated. This system has come under public pressure because of doubts as to its efficiency and the FDA's recent GRAS rule is part of the response. The FDA guidance for testing food additives, known as the "Redbook", is about two decades old. Work toward a new "Redbook" is on the way, but the US Grocery Manufacturer Association (GMA) also has initiated the development of an independent standard on how to perform GRAS determinations. This review of the current guidance shows a very rigorous system for higher concern levels, but also many waiving options. Opportunities and challenges for safety evaluations of food additives are discussed. Where scientific progress has allowed improving existing and adapting new methods, these should be adopted to improve product safety and animal welfare. The continuous adaptation of such improved methods is therefore needed. Especially, there are opportunities to embrace developments within the toxicity testing for the 21 st century movement and evidence-based toxicology approaches. Also, the growing understanding of the limitations of traditional tests needs to be considered.

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Section: Summarize: "The So-called 'Gras Exemption' To the Statutory mentioning

confidence: 99%

Section: Revising Earlier Gras Evaluationsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Hartung

2018

ALTEX

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“…The level and extent of testing is very different for various products: while pesticides, for example, are subjected to more than 30 animal tests, food additives often are not tested at all (Neltner et al, 2013). Sure, pesticides are designed to kill (insects, etc.)…”

Section: The Disparity Of Testing Requirements and Risk Acceptance Fomentioning

confidence: 99%

Evolution of toxicological science: the need for change

Hartung

2017

IJRAM

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Evolution requires change but the field of toxicology has not kept pace. The top ten problems urging change are: 1) disparity of testing requirements and risk acceptance for different products and geographical areas; 2) throughput and testing costs versus testing needs; 3) limited predictivity for humans; 4) precautionary approaches from drug development adapted to other areas; 5) animal use; 6) traditional tests unsuitable for new products; 7) lack of coverage for new hazards; 8) failure to address mixtures of toxicants; 9) lack of coverage for individual susceptibilities and vulnerable subpopulations; 10) poor basic research and publication standards. The intransigence at the root of these problems is discussed with reference to current international toxicological policies and methods. For each, the limitations are reviewed with reference to key literature. While current approaches are still needed, there is room for substantial change. To meet the challenges of the 21st century, revolution rather than evolution is required.

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Ultrasensitive Electrochemical Sensor for Maltol in Wines Using Graphene Oxide‐Wrapped Amino‐Functionalized Carbon Sphere as Sensing Electrode Materials

Gan

Liu

et al. 2015

Electroanalysis

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We reported an electrochemical sensor with specificity toward maltol with rapid response and high sensitivity, using graphene oxide (GO)‐wrapped amino‐functionalized carbon sphere (ACS) hybrids as the conductive channel. The results indicated that a well‐organized structure was successfully prepared, based on specific electrostatic attractions between the ACS and the GO nanosheets. Next, a sensitive and selective electrochemical sensor was successfully constructed for the direct detection of maltol by casting a GO‐ACS film onto the surface of a glassy carbon electrode. The oxidative peak current increased linearly with the concentration of maltol in the range of 0.1 µM∼0.8 mM using differential pulse voltammetry, and the detection limit was 24 nM with S/N=3.

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Data gaps in toxicity testing of chemicals allowed in food in the United States

Cited by 79 publications

References 8 publications

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Rebooting the generally recognized as safe (GRAS) approach for food additive safety in the US

Evolution of toxicological science: the need for change

Ultrasensitive Electrochemical Sensor for Maltol in Wines Using Graphene Oxide‐Wrapped Amino‐Functionalized Carbon Sphere as Sensing Electrode Materials

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