Perspectives on How FDA Assesses Exposure to Food Additives When Evaluating Their Safety: Workshop Proceedings

Food additives and substances considered “generally recognized as safe” must not be allowed in food unless there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. Scientists determine safety by ensuring that the expected exposure is less than the acceptable daily intake. The U.S. Food and Drug Administration (FDA) provides guidance documents to assist safety assessors in this analysis. A November 2011 workshop sponsored by The Pew Charitable Trusts, the Institute of Food Technologists, and the journal Nature reviewed the agency's exposure assessment approaches. More than 70 experts from government (including FDA), industry, academia, and public interest organizations examined the principles underlying dietary exposure assessments for substances added to human food, and responded to questions about current methods. FDA's approach was seen as serving the agency reasonably well, but participants identified opportunities for improvement. Although reaching a consensus was not a goal, general agreements emerged that FDA should develop a science‐based framework to prioritize and reassess prior safety decisions, and conduct more extensive postmarket monitoring. Participants discussed the possibility of harmonizing different approaches to assess dietary exposure. They generally agreed that collaboration, communication, and exchanging scientific information between agencies and stakeholders would help assessors use the most current information to make better decisions. Participants identified data gaps and opportunities to fill the gaps using new tools and technologies. Participants generally agreed on the need to consider all dietary sources in a cumulative dietary exposure assessment.     

TAR-RNA binding by HIV-1 Tat protein is selectively inhibited by its L-enantiomer

An oligoribonucleotide, corresponding to the Tat-interactive top half of the HIV-1 TAR RNA stem-loop, was synthesized in both the natural D- and the enantiomeric L-configurations. The affinity of Tat for the two RNAs, assessed by competition binding experiments, was found to be identical and is reduced 10-fold for both, upon replacement of the critical bulge residue U23 with cytidine. It is suggested that this interaction of the flexible Tat protein depends strongly upon the tertiary structure of a binding pocket within TAR, but not upon its handedness, and may be described by a 'hand-in-mitten' model.     

Enhancing FDA's Evaluation of Science to Ensure Chemicals Added to Human Food Are Safe: Workshop Proceedings

Abstract: Science and expert judgment are the foundation for safety assessments of chemicals added to food to ensure their use is safe. Hazard characterization is the first step in a safety assessment. Advances in science and technology pose challenges to the regulatory system and raise questions about whether the current hazard identification and characterization process is able to systematically and transparently encompass such advances while remaining defensible. An April 2011 workshop sponsored by The Pew Charitable Trusts, the Institute of Food Technologists, and the journal Nature brought together over 80 experts in science and food policy from government, industry, academia, and public interest organizations to examine the principles underlying the development and use of scientific evidence needed for chemical hazard characterization. Participants discussed challenges of identifying adverse health effects, advances in science, uses of new screening technologies and human biomonitoring data, updating of study designs, and development and review of toxicity test guidelines. Brainstorming sessions allowed participants to propose alternatives to enhance FDA's evaluation of science for safety assessment. Although there was no intention to reach a consensus, several themes emerged including the need for clear procedures to develop validated toxicity tests; importance of regularly updating guidance documents relied upon by regulators and industry; benefits of transparency and public access to information; potential for greater interagency collaboration; opportunities to improve hypothesis‐based research to make it more useful to regulatory decision making; and importance of staying abreast of scientific developments to ensure that safety assessments are made using sensitive and relevant methods.     

Navigating the U.S. Food Additive Regulatory Program

Abstract: The Food Additives Amendment of 1958 is the foundation for the U.S. food additive regulatory program, which oversees most substances added to food. This article is a comprehensive review of the program, including original analysis of pre‐ and postmarket safety standards for various categories and subcategories of substances and their uses; assigning the more than 10000 substances currently allowed in human food to those categories; and analyzing the U.S. Food and Drug Administration's (FDA) review of more than 1900 petitions and notifications received from 1990 to 2010. Overall, federal agencies made approximately 40% of the 6000 safety decisions allowing substances in human food. These decisions allowed an estimated 66% of the substances currently believed to be used in food. Manufacturers and a trade association made the remaining decisions without FDA review by concluding that the substances were generally recognized as safe (GRAS). Robust premarket safety decisions are critical since FDA has limited resources to monitor potentially significant scientific developments and changing uses of a substance after it enters commerce and only has access to published data or data submitted to it. In the late 1990s, FDA moved from promulgating rules for its decisions for food contact and GRAS substances to reviewing manufacturer safety decisions and posting the results of the review on the agency's website. This shift appears to have encouraged manufacturers to submit their decisions to FDA for review but has limited public opportunity to provide input.     

Looking Back to Look Forward: A Review of FDA's Food Additives Safety Assessment and Recommendations for Modernizing its Program

Scientists participating in 2 multistakeholder meetings in 2011 and in other events have identified a number of ways in which the methods the U.S. Food and Drug Administration (FDA) uses to assess the safety of chemicals in human food should be improved and updated. We evaluated whether FDA's current methods, including its decision‐making process, are outdated, as alleged by its critics. We examined a 1982 report by the Select Committee on GRAS Substances (SCOGS) that included suggestions to enhance food additive safety. FDA established SCOGS to review the safety of “generally recognized as safe” (GRAS) substances in response to a directive by President Nixon. When evaluating FDA's response to SCOGS’ suggestions, we found that many remain unresolved and relevant today. Our analysis demonstrates that in many cases FDA has not kept pace with scientific developments. Although difficult to pinpoint, we concluded that this situation became more significant after 1997, when FDA launched the voluntary GRAS notification program aimed at enticing manufacturers to inform the agency of their own safety decisions. Looking forward, we recommend that the agency convene an unbiased and independent expert workgroup to conduct a comprehensive review of FDA's science and decision making and develop a path to modernize food additives safety assessment. Areas of concern include toxicology test guidelines, tools used to predict health outcomes, conflict of interest in manufacturers’ decisions, lack of a reassessment strategy, and lack of a definition of harm.     

Annual review of Asian American Psychology, 2009.

The purpose of this study was to provide a systematic and critical review of research articles on Asian American psychology that were published in 2009. A search using PsycINFO led to the identification of 134 articles, and each of these articles were evaluated in terms of its topic areas, research methodology, and findings. The results showed that the articles covered a wide array of topics, including acculturation and enculturation, adoptees, career, counseling and clinical issues, educational experiences, families, health and health-related behaviors, identity, immigrants and refugees, interpersonal relationships, lesbian/gay/bisexual/transgender/intersex/questioning, masculinity, older adults, personality, politics, psychopathology, racism, spirituality, stress and coping, violence, women, and youths. A summary of articles within these topics areas are provided. In addition, various characteristics of this body of literature are presented with their implications for future research. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Application of active queue management for real-time adaptive video streaming

Telecommunication Systems - Video streaming currently dominates global Internet traffic. Live streaming broadcasts events in real-time, with very different characteristics compared to...     

The potential impact of violent victimization on somatic symptoms among Asian American adolescents: A national longitudinal study.

This study explored the mental health repercussions among Asian American adolescents following experiences of violent victimization. Utilizing a subsample of Asian American adolescents from Waves I and II of the National Longitudinal Study of Adolescent Health (Add Health), this study examined the relationship between violent victimization and somatic symptoms one year later, as well as moderators of this relationship. Results from a hierarchical multiple regression analysis showed that emotional bonds with fathers were negatively related to somatic symptoms. In addition, instrumental bonds with mothers weakened the link between violent victimization and somatic symptoms. The practical implications of these results for addressing the psychosocial needs of Asian American adolescents were discussed. (PsycINFO Database Record (c) 2011 APA, all rights reserved)