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July-September 2012 Research Highlights


July 6
Triclosan Effects on Fat Cell (Adipocyte) Maturation

NCTR scientists, in collaboration with the FDA Center for Biologics Evaluation and Research and the Arkansas Department of Health, have shown that the common antimicrobial agent, triclosan, at dose levels that are not toxic to cells and that are in the range observed in human blood, inhibits fat-storage cell (adipocyte) maturation in vitro.  Adipocyte maturation was inhibited in a concentration-dependent manner and was determined by structural changes and decreased gene expression of adipocyte differentiation biomarkers.  Triclosan is known to be toxic to tissue at high doses; but the question of triclosan toxicity at very low, continuous exposures from hygiene products requires further study.  The results of this study have recently been published in Toxicology and Applied Pharmacology (2012, 262: 117-123). 

For additional information, please contact Baitang Ning, Ph.D., Division of Systems Biology, FDA/NCTR, or Jia-Long Fang, Ph.D., Division of Biochemical Toxicology, FDA/NCTR.

July 13
Chemical Inactivation of Protein Toxins on Food Contact Surfaces

NCTR scientists collaborated with the FDA Center for Food Safety and Applied Nutrition and the Illinois Institute of Technology to show that sodium hypochlorite (the active ingredient in common household bleach) and hypochlorite-containing products are the most effective agents for inactivating ricin in dried food residues (infant formula, peanut butter, pancake mix, etc.) on stainless steel food contact surfaces.  Ricin is a plant toxin that is a potential biological warfare agent to target/poison the food supply.  This study, which compares the effectiveness of multiple chemical agents to decontaminate food contact surfaces — as in a food processing facility — was recently accepted for publication in the Journal of Agricultural and Food Chemistry (

For additional information, please contact William Tolleson, Ph.D., Division of Biochemical Toxicology, FDA/NCTR.

July 20
Toxicology Forum — July 9-12

NCTR scientists made presentations in discussions concerning the safety assessment of Bisphenol A (BPA) at the 38th Summer Meeting of the Toxicology Forum held July 9-12, 2012.  The session opened with an overview of the National Institute of Environmental Health and Safety (NIEHS)-funded Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA).  This project will provide tissues from ongoing GLP-studies being conducted at NCTR to several NIEHS grantees exploring various effects of BPA.  NCTR scientists summarized results of a subchronic (90 day) BPA toxicity study conducted at NCTR, the extensive pharmacokinetic data generated in multiple species in NCTR studies, and human exposure estimates (blood levels) generated by a physiologically based pharmacokinetic model that utilized those pharmacokinetic data. 

For additional information, please contact Barry Delclos, Ph.D., and Daniel Doerge, Ph.D., Division of Biochemical Toxicology, FDA/NCTR.

July 27
Advancing Regulatory Science Through Toxicogenomics

Scientists from NCTR and Hannover Medical School have published a review article in Toxicological Sciences disclaimer icon that addresses the use of toxicogenomics in drug development and safety assessments.  The authors focus on two newly released toxicogenomic databases, the Japanese Toxicogenomics Project (TGP) and DrugMatrix.  They detail the commonalities and differences of these databases and discuss how these databases could be utilized to address key questions in drug safety.  It is anticipated that these databases will advance the field of toxicogenomics by stimulating knowledge discovery and the development of novel data-mining tools.  Development of emerging methodologies for safety assessment of FDA-regulated products is one of the main focuses in advancing regulatory science. 

For additional information, please contact Weida Tong, Ph.D., Acting Director, Division of Bioinformatics and Biostatistics, FDA/NCTR.


August 3
Fighting Drug Failure—July 25

Two NCTR scientists gave presentations at Fighting Drug Failure: A Marie Curie Initial Training Network (ITN) disclaimer icon  Event held July 25, 2012, in Liverpool, United Kingdom.  The talks addressed research efforts in utilizing exome sequencing to identify genetic variants in cardiovascular disease risks and drug responses; and the FDA-led MicroArray and Sequencing Quality Control (MAQC/SEQC) Project in personalized medicine.  The ITN is a European Union initiative to provide training through international research projects.  This program focuses on providing the scientific basis for predicting adverse drug reactions and the use of pharmacogenomics to speed translation of research to the clinic. 

For additional information, please contact Baitang Ning, Ph.D., Personalized Medicine Branch, Division of Systems Biology, FDA/NCTR, or Leming Shi, Ph.D., Bioinformatics Branch, Division of Bioinformatics and Biostatistics, FDA/NCTR.

Central Arkansas Undergraduate Research Symposium—July 25

Nine undergraduate participants of NCTR’s Summer Student Research Program (SSRP) gave poster presentations on their research projects at the First Annual Central Arkansas Undergraduate Research Symposium held July 25, 2012, at the William J. Clinton Presidential Center in Little Rock, Arkansas.  The SSRP is a 10-week program that provides hands-on research and laboratory experience with FDA/NCTR scientists as mentors.  Through participation in this annual symposium, NCTR’s SSRP will partner with other summer undergraduate research programs in the area to support the training of the next generation of scientists and clinicians. 

For additional information, please contact Barbara Parsons, Ph.D., Division of Genetic and Molecular Toxicology, FDA/NCTR.

August 10
Urine Metabolite Biomarker of Kidney Injury

NCTR scientists have identified hydroxyproline as a potential noninvasive, urinary biomarker of melamine and cyanuric acid-induced renal injury and fibrosis.  Melamine and cyanuric acid alone are relatively nontoxic and do not result in acute kidney injury; however, coexposure to melamine and cyanuric acid has been shown to induce renal toxicity through formation of crystals within the kidney.  The study showed that rats, coexposed to melamine and cyanuric acid in their diet for 28 days, exhibited an increase in urinary hydroxyproline in a dose-dependent manner; and high levels of urinary hydroxyproline correlated with kidney fibrosis.  Furthermore, hydroxyproline was elevated at low doses of melamine and cyanuric acid that caused only minimal to mild histopathological changes and no significant increases in classical blood biomarkers, such as blood urea nitrogen and creatinine.  Thus, urinary hydroxyproline may be an earlier biomarker of renal injury, than the currently used blood markers.  This study was supported through the Interagency Agreement with the National Toxicology Program.  A manuscript describing this study was recently accepted for publication in Food and Chemical Toxicology.

For additional information, please contact Richard Beger, Ph.D., Biomarkers and Alternative Models Branch, Division of Systems Biology, FDA/NCTR.

August 17
Food Safety Research

Scientists from NCTR and Seoul National University, Korea, have shown that low levels of the veterinary antibiotic, enrofloxacin, had minimal effects on intestinal microbial communities in human fecal slurries.  The study, which tested a concentration range of enrofloxacin from low (typically found in edible tissue residue analysis) to high (therapeutic) concentrations, showed that increasing concentrations perturbed the intestinal microbial community and functional gene expression.  The in vitro study used denaturing gradient gel electrophoresis, 16S RNA gene-based pyrosequencing, and transcriptomic techniques to address pivotal questions raised by national regulatory authorities about potential human-health risk from the impact of antimicrobial residues in foods derived from animals treated with antimicrobial agents on human intestinal microbiota.  The results of this study have been published in Anaerobe (2012, 18:310-320). 

For additional information, please contact Carl E. Cerniglia, Ph.D., Director, Division of Microbiology, FDA/NCTR.

August 24
Globalization of Regulatory Science

Twenty scientists, including eleven NCTR postdoctoral fellows from six different countries, enrolled in the inaugural class to obtain the Graduate Certificate in Regulatory Sciencesdisclaimer icon developed at the Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences.  This program was developed under the Memorandum of Understanding between FDA and the State of Arkansas promoting development of regulatory science.  Two courses are available this fall including FDA Regulations and Methods of Risk Assessment.  The interest in this program demonstrates both the critical need for knowledge in regulatory sciences and the global influence of FDA.

For additional information, please contact William Slikker, Jr., Ph.D., Director, FDA/NCTR.

August 31
"Hands-On" Training in Nanotechnology- August 28-30

The NCTR/ORA Nanotechnology Core Facility organized and taught a “hands-on” training workshop on August 28-30, 2012, which was attended by nine scientists from six FDA Centers and ORA.  The workshop focused on the theory, strengths, and weaknesses of size-measurement techniques commonly used for nanomaterials.  The experience gained will enable researchers and reviewers to understand the methodology used in the size determination of materials being submitted to the agency for approval.  The workshop is part of the overall Nanotechnology Task Force program to enhance science and knowledge in nanotechnology at FDA through teaching/training programs, support for research through FDA's Collaborative Opportunities for Research Excellence program, and core facilities (NCTR/ORA and White Oak). 

For additional information, please contact Paul Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.

Genetic Toxicology- August 27-28

An NCTR scientist gave a plenary lecture at the Chinese Society of Toxicology 2012 international workshop on Genetic Toxicology held August 27-28, 2012, in Shanghai, China.  The focus of the presentation was on new methods for evaluating chemically induced genetic damage.  The goal of the workshop was to provide training on the latest progress on new methods which may ultimately be used under the ICH S2(R1) Guideline on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.

For additional information, please contact Robert Heflich, Ph.D., Division of Genetic and Molecular Toxicology, FDA/NCTR.


September 7
NCTR Represented in U.S. Dept. of State Embassy Science Fellows Program

Margaret Miller, Ph.D, NCTR Associate Director for Regulatory Activities, is completing a five-week assignment to advance regulatory science at the Taiwan Food and Drug Administration in Taipei, Taiwan. The program places U.S. scientists overseas to advance international collaboration by assisting foreign governments in the development of national research and development priorities.  Dr. Miller was sponsored by the USDA Foreign Agricultural Service. 

For additional information, please contact Dr. Margaret Miller, Associate Directory for Regulatory Activities, FDA/NCTR.

2012 Global Summit on Regulatory Science (GSRS-2012)

A summary of the activities at the Second Annual Global Summit on Regulatory Science is available in Toxicological Sciencesdisclaimer icon.  The conference discussed innovative technologies and partnerships to enhance the translation of basic science into regulatory applications within the global market context.  The attendees addressed the intercountry disparity for the utilization of new genomic tools and classical toxicology in safety assessments; and the key role that training and educational programs will play in the global advancement of regulatory science.  The conference, which was cosponsored by NCTR, Zhejiang University, and the Chinese Academy of Engineering, was held in Hangzhou, China, and was attended by more than 80 government, industry, and academic scientists from ten countries. 

For additional information, please contact William Slikker, Jr., Ph.D., Director, FDA/NCTR.

September 14
Nanotoxicology 2012—September 4-7

NCTR scientists presented keynote addresses at the 6th International Conference on Nanotoxicology that was held September 4-7, 2012, in Beijing, China.  The first address focused on the activities of the FDA Nanotechnology Task force and model studies for dermal penetration of nanoscale materials; the second presentation discussed the ongoing interdisciplinary activities for the safety assessment of gold and carbon nanoparticles.  The conference was organized by the National Center for Nanoscience and Technology of China and provided an international forum for the discussion of the current understanding of the toxicity of nanomaterials.

For additional information, please contact Paul Howard, Ph.D., Director, Office of Scientific Coordination, FDA/NCTR.

SmartTots Workshop—September 10

NCTR scientists participated in a SmartTots workshop held at the FDA White Oak campus on September 10, 2012.  The workshop was called to outline a brief evidence-based message that will convey current knowledge regarding the risks of using general anesthesia and sedation in infants and children.  A consensus document will be available for distribution in the near future.  SmartTots is a public/private partnership between the FDA and the International Anesthesia Research Society (IARS).

For additional information, please contact William Slikker, Jr., Ph.D., Director, FDA/NCTR, or Merle Paule, Ph.D., Director, Division of Neurotoxicology, FDA/NCTR.

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