The Food and Drug Administration (FDA) is a regulatory agency of the United States federal government This article describes the scope of work of each of the FDA's major components, and addresses the role of statisticians at FDA


Keywords:

drug regulation;
clinical trials;
medical devices;
safety;
bioassay

Food and Drug Administration (FDA)

Background Nanotechnology applications can be found in agricultural production, animal feed, food processing, food additives and food contact materials (hereinafter referred to as agri/feed/food). A great diversity of nanomaterials is reported to be currently used in various applications, while new nanomaterials and applications are reported to be in development. Scope and approach It is expected that applications of nanomaterials in agri/feed/food will increase in the future and thereby increase the human and environmental exposure to such materials. To gain up-to-date knowledge we explored and reviewed the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors upon the request of the European Food Safety Authority (EFSA). In this paper the results of the project are highlighted and discussed in more detail. Key findings and conclusions The majority of the applications of nanomaterials that we identified concerned application in food as food additives and food contact materials, while much fewer applications seem to be developed for agriculture and feed. Nano-encapsulates, silver, titanium dioxide and silica are the most often mentioned nanomaterials in the literature. About half of the identified applications are claimed to be already in use. In-development applications are found for nano-encapsulates and nano-composites in novel foods, food and feed additives, biocides, pesticides and food contact materials.

Nanomaterials for products and application in agriculture, feed and food

Many products used in everyday life are made with the assistance of nanotechnologies. Cosmetic, pharmaceuticals, sunscreen, powdered food are only few examples of end products containing nano-sized particles (NPs), generally added to improve the product quality. To evaluate correctly benefits versus risks of engineered nanomaterials and consequently to legislate in favor of consumer’s protection, it is necessary to know the hazards connected with the exposure levels. This information implies transversal studies and a number of different competences. On analytical point of view the identification, quantification and characterization of NPs in food matrices and in cosmetic or personal care products pose significant challenges, because NPs are usually present at low concentration levels and the matrices, in which they are dispersed, are complexes and often incompatible with analytical instruments that would be required for their detection and characterization. This paper focused on some analytical techniques suitable for the detection, characterization and quantification of NPs in food and cosmetics products, reports their recent application in characterizing specific metal and metal-oxide NPs in these two important industrial and market sectors. The need of a characterization of the NPs as much as possible complete, matching complementary information about different metrics, possible achieved through validate procedures, is what clearly emerges from this research. More work should be done to produce standardized materials and to set-up methodologies to determine number-based size distributions and to get quantitative date about the NPs in such a complex matrices.

/pdf/nanomaterials-in-consumer-products-a-challenging-analytical-1amc37d8d4.pdf

Nanomaterials in consumer products: a challenging analytical problem.

textA term map is a map that visualizes the structure of a scientific field by showing the relations between important terms in the field. The terms shown in a term map are usually selected manually with the help of domain experts. Manual term selection has the disadvantages of being subjective and labor-intensive. To overcome these disadvantages, we propose a methodology for automatic term identification and we use this methodology to select the terms to be included in a term map. To evaluate the proposed methodology, we use it to construct a term map of the field of operations research. The quality of the map is assessed by a number of operations research experts. It turns out that in general the proposed methodology performs quite well.

/pdf/automatic-term-identification-for-bibliometric-mapping-1utn18clpt.pdf

Automatic Term Identification for Bibliometric Mapping

Manufactured nanoparticles in the aquatic environment-biochemical responses on freshwater organisms: A critical overview.

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"; Part 1: Compilation of information concerning the experience with the definition

/pdf/nanoreg-harmonised-terminology-for-environmental-health-and-55r3n0c651.pdf

NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials

https://publications.jrc.ec.europa.eu/repository/bitstream/111111111/52947/1/jrc112224_final_online.pdf

Mapping Nanomedicine Terminology in the Regulatory Landscape

http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/48957/1/kjna28676enn.pdf

Quiros Pesudo Laia

Papers

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"; Part 1: Compilation of information concerning the experience with the definition

NANoREG harmonised terminology for environmental health and safety assessment of nanomaterials

Mapping Nanomedicine Terminology in the Regulatory Landscape

NANO(materials): EHS, Research, INnovation, ReGulation