Research Proposals

Alternatives to animal testing:  Applications to ingredient safety
There is a need to understand the relevance of the Tox21 / ToxCast programs to ingredient safety risk assessment.  Identify (or speculate about) applications of Tox21 to new ingredient safety assessments, and address the following question:  How can we reach the ultimate goal of confidently determining safety of a new chemical (without animal testing)? 

Applications of computational approaches to ingredient safety
The specific question can look at safety assessment of natural ingredients and components. Companies can gain actual results for products, while chemical and ingredient companies can (easily) leverage and apply the published approach, keeping in mind that foods and natural ingredients are chemicals, per se.

Exposure science / modeling:  Central database for exposure / intake data
Accurate data related to current intake levels of different foods and associated food additives is lacking.  The current management approach is to use NHANES (National Health and Nutrition Examination Survey), and to support efforts underway at ILSI North America. A research strategy under the aegis of CRIS could be developed to establish a central database and management system for food commodity and food additive intake information.  To do so will require CRIS to establish expertise for the latest exposure modeling option.

Exposure science / modeling:  General application  
Estimation of intake of ingredients and additives or exposure to constituents in foods, beverages, and consumer products is an extremely important part of a risk assessment.  In order to determine the risk associated with the occurrence of a chemical or compound in a specific product or type of product, understanding the cumulative exposure is crucial.  In addition, the development of new tools that can be applied in developed and developing countries to estimate product use and consumption are needed.

Exposure science / modeling:  Population trends
Consider dietary intake studies, but also food compositional studies in different areas to compare population trends and variations.

Foods and cancer, or non-communicable diseases
How much do foods actually contribute to cancer development in individuals?  Recent research is suggesting it is more than previously thought.  Consider a follow-up question - How much do foods contribute to other non-communicable diseases in individuals?

Maillard reaction products
A need exists to better understand the extent of occurrence of Maillard reaction products, such as 4-Methylimidazole, in numerous foods in order to demonstrate that their presence in single products or product types is not exclusive.

Relevance of mouse (B6C3F1) lung tumors to human risk
A need exists to better understand the concordance between B6C3F1 mouse lung tumors and human risk.  A long list of compounds associated with food and beverage intake and environmental exposure, and occupational exposures when given orally have demonstrated such tumors without corresponding or other tumors in rats.  This evidence has put numerous food regulatory and safety bodies and other regulatory bodies such as environmental in a difficult position to have to take action on such evidence.

Role of metabolism in DART effects associated with N-hexane
The Prop 65 Developmental and Reproductive Toxicant Identification Committee recently requested that California’s Office of Environmental Health Hazard Assessment examine N-hexane’s DART (Developmental and Reproductive Toxicant) effects related to its metabolism to 2,5-hexanedione.  Proposal would be to first conduct a literature review to determine to what extent the metabolism of n-hexane to 2,5-hexanedione is relevant to humans.  If the current state of the scientific research is insufficient to allow for an evidence-based review, then primary research is warranted, which could eventually lead to the development of a physiologically based pharmacokinetic (PBPK) model.

Role that gut plays in toxicological evaluation:  Emulsifiers and gut microbiome
New, albeit low quality data is now available which purports GI impact by emulsifiers (irritation, gut microbiome dysbiosis), and a review paper has been proposed to address the question – Do emulsifiers adversely impact the human GI tract (including consideration for gut microbiome dysbiosis) at current exposure levels in food?  The impact of emulsifiers on the gut microbiome could also be addressed by a research strategy, which would include several questions, such as – Is there a cumulative effect with exposure to multiple emulsifiers?

Role that gut plays in toxicological evaluation:  General
Definitive research on the role that the gut plays in toxicological evaluation could focus on one of several areas. For example, these might include the role of intestinal cells in the transport of molecules into the bloodstream, including any modification to those molecules during transport or the interaction of a particular food ingredient and the gut biome and subsequent impact on toxicological characteristics of the ingredient.

Toxic substances and milk / meat supply chain
Any information on toxic substances that may be passed through the milk or meat supply chain.

Toxicology of mixtures
Mixture toxicology remains a subject of great interest.  Foods and beverages are inherently mixtures.  The use of “data resources” combined with understanding from toxicology studies of ingredients, additives, and constituents of foods could provide valuable insights into better understanding mixture toxicology and introduce or re-introduce the BRAFO (Benefit-Risk Analysis for Foods) concept developed by ILSI Europe to the scientific community.  A consumer facing companion piece would be of great benefit.

Toxicology of mycotoxins
Utilize CRIS’ expertise in mycotoxins to look at sprouted grains, an emerging food trend which may have food safety implications.

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