Evaluate potential toxic/carcinogenic effects resulting from exposure to dietary supplements and nanoscale-sized particles associated with food containers, food preparation surfaces, and food wraps. These studies are supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/NIH.By conducting nanomaterials research, FDA will have a better understanding of the consequences of human exposure to nanoscale materials in food preparation materials. These studies will help determine early predictors of toxicity-risk to food preparation materials.This research will help the FDA determine the health effects from exposure to dietary supplements and from nanoparticles associated with food preparation materials.<b>Accomplishment:</b>The nomination to study Aloe vera came from the National Cancer Institute, because of Aloe’s widespread use and concern that some components may cause cancer. The two-year study of a non-decolorized whole leaf extract of Aloe vera given in an animal’s drinking water found clear evidence of carcinogenic activity in male and female rodents, based on tumors of the large intestine. There was no evidence of carcinogenic activity in the rodents. These rodent studies give cause for serious concern. Some questions that need to be answered before their importance can be fully appreciated include: 1) what products are actually in the market place, 2) what are the aloin levels across a broad spectrum of products, and 3) what are the patterns of human exposure? There is not enough information currently available to know how much Aloe vera people are consuming or for how long. Consequently, further research is needed. For further information on this study and what it means to public health, please reference the <a href= http://ntp.niehs.nih.gov/Ntp/About_Ntp/Trpanel/2011/April/DraftTR577.Pdf target=”_blank”> NTP Report on Aloe Vera </a>.maina. Complete the NCTR technical report on Aloe vera dosed water studies and submit report to NCTR Quality Assurance Unit4/30/2010Completed4/30/2010mainb. Submit revised NCTR technical report on Aloe vera dosed water studies to NCTR Office of Scientific Coordination for NTP report formatting8/1/2010Completed8/1/2010mainc. Present technical report on Aloe vera dosed water studies to NTP Technical Report Review Committee1/1/2011<i>(4/5/2011)</i>Completed4/5/2011ON TRACKON TRACKmaina. Submit concept paper to CFSAN to evaluate the carcinogenic potential of Aloe charcoal-filtered whole leaf extract and senna11/1/2010Completed6/20/2010mainb. Outline preliminary protocol to TSSRC on the carcinogenic potential of Aloe charcoal-filtered whole leaf extract and senna11/1/2010Completed11/16/2010mainc. Obtain final approval for protocol on the carcinogenic potential of Aloe charcoal-filtered whole leaf extract and senna1/3/2011<i>(4/15/2011)</i>Completed5/26/2011maind. Conduct researchTBDNot Yet Startedmaine. Complete the assessment of research findingsTBDNot Yet Startedmainf. Complete the draft manuscriptTBDNot Yet Startedmaing. Complete the peer review (NCTR and other FDA researchers) of draft manuscriptTBDNot Yet Startedmainh. Obtain NCTR Center Director approval of the draft manuscript via the document tracking systemTBDNot Yet Startedmaini. Submit manuscript to a scientific journalTBDNot Yet StartedNIEHSNational Institute of Environmental Health SciencesNTPNational Toxicology ProgramNIHNational Institutes of HealthCFSANCenter for Food Safety and Applied NutritionTSSRCToxicology Study Selection and Review Committeehttp://www.fda.gov/AboutFDA/Transparency/track/ucm203296.htmFDA-TRACK NCTR Dashboardhttp://www.fda.gov/AboutFDA/Transparency/track/ucm252974.htmFDA-TRACK Research Glossary਍††਍਍਍਍਍਍਍