Principles for building public-private partnerships to benefit food safety, nutrition, and health research.

The present article articulates principles for effective public-private partnerships (PPPs) in scientific research. Recognizing that PPPs represent one approach for creating research collaborations and that there are other methods outside the scope of this article, PPPs can be useful in leveraging diverse expertise among government, academic, and industry researchers to address public health needs and questions concerned with nutrition, health, food science, and food and ingredient safety. A three-step process was used to identify the principles proposed herein: step 1) review of existing PPP guidelines, both in the peer-reviewed literature and at 16 disparate non-industry organizations; step 2) analysis of relevant successful or promising PPPs; and step 3) formal background interviews of 27 experienced, senior-level individuals from academia, government, industry, foundations, and non-governmental organizations. This process resulted in the articulation of 12 potential principles for establishing and managing successful research PPPs. The review of existing guidelines showed that guidelines for research partnerships currently reside largely within institutions rather than in the peer-reviewed literature. This article aims to introduce these principles into the literature to serve as a framework for dialogue and for future PPPs.

How experts are chosen to inform public policy: can the process be improved?

The ever-increasing complexity of the food supply has magnified the importance of ongoing research into nutrition and food safety issues that have significant impact on public health. At the same time, ethical questions have been raised regarding conflict of interest, making it more challenging to form the expert panels that advise government agencies and public health officials in formulating nutrition and food safety policy. Primarily due to the growing complexity of the interactions among government, industry, and academic research institutions, increasingly stringent conflict-of-interest policies may have the effect of barring the most experienced and knowledgeable nutrition and food scientists from contributing their expertise on the panels informing public policy. This paper explores the issue in some depth, proposing a set of principles for determining considerations for service on expert advisory committees. Although the issues around scientific policy counsel and the selection of advisory panels clearly have global applicability, the context for their development had a US and Canadian focus in this work. The authors also call for a broader discussion in all sectors of the research community as to whether and how the process of empaneling food science and nutrition experts might be improved.

Funding food science and nutrition research: financial conflicts and scientific integrity.

There has been substantial public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines regarding industry funding for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement.

Funding food science and nutrition research: financial conflicts and scientific integrity.

There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines, regarding industry funding, for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. The Guiding Principles are as follows. In the conduct of public/private research relationships, all relevant parties shall: 1) conduct or sponsor research that is factual, transparent, and designed objectively; according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) prior to the commencement of studies, ensure that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time-frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; and 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; require that such researchers publish only under the auspices of the CRO.

Funding food science and nutrition research: financial conflicts and scientific integrity.

There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. Whereas biases can come from myriad sources, the overwhelming focus of the discussion to date has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored research. This article, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. In the conduct of public/private research relationships, all relevant parties shall 1) conduct or sponsor research that is factual, transparent, and designed objectively, and, according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) ensure, before the commencement of studies, that there is a written agreement that the investigative team has the freedom and obligation to attempt to publish the findings within some specified time frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; and require that such researchers publish only under the auspices of the CRO.

Aflatoxin: Toxicity to Dairy Cattle and Occurrence in Milk and Milk Products - A Review.

Aflatoxins are toxic and carcinogenic secondary metabolites produced by some common aspergilli during growth on feeds, foods or laboratory media. Aflatoxin B1 (AFB1) is a decaketide (C20-polyketide) which is synthesized by the mold from acetate units via the polyketide pathway. Methionine contributes the methoxy-methyl group. Six known intermediate compounds in the biosynthesis of AFB1 include norsolorinic acid, averantin, averufin, versiconal hemiacetal acetate, versicolorin A and sterigmatocystin. Other aflatoxins (B2, B2a, G1, G2 and G2a) appear to be conversion products of AFB1. When aflatoxins, and in particular AFB1, occur in feed and are consumed by dairy cattle, a variety of symptoms can occur, which includes unthriftiness, anorexia and decreased milk production. Changes in amounts of enzymes and other blood constituents also result from ingestion of AFB1. The hepatic microsomal mixed-function oxidase system of the cow converts some of the ingested AFB1 into aflatoxin M1 (AFM1), which is excreted in milk. AFM1 retains the toxicity of, but is less carcinogenic than AFB1. Certain heat treatments associated with milk processing appear to inactivate a portion of the AFM1 in milk. If raw milk contains AFM1, products (fluid products, nonfat dried milk, cultured milks, natural cheese, process cheese, butter) made from such milk also will contain AFM1. AFM1 appears to be associated with the casein fraction of milk, hence concentrating the casein in the manufacture of products (e.g. cheese, nonfat dry milk) is accompanied by concentrating of the AFM1. Methods involving thin-layer or high-performance liquid chromatography are commonly used to detect and quantify AFM1 in milk and milk products.

Inactivation of Aflatoxin M1 in Milk Using Hydrogen Peroxide and Hydrogen Peroxide plus Riboflavin or Lactoperoxidase.

Use of hydrogen peroxide (H2O2), H2O2 plus riboflavin (Rib.) and H2O2 plus lactoperoxidase (LPO) to inactivate aflatoxin M1 (AFM1) in naturally contaminated raw whole milk was examined. Effectiveness of treatments was evaluated by determining percent of AFM1 inactivation, using thin-layer chromatography and fluorodensitometry. Inactivation values ranged from 0 to 98%. Maximum inactivation (98%) was obtained using 1% H2O2 plus 0.5 mM Rib. (30°C, 30 min) followed by heating at 63°C for 30 min. Eighty-five percent of measurable AFM1 was eliminated when 5 units of LPO plus 0.1% H2O2 (4°C for 3 d) were used. Singlet oxygen and/or hypochlorous acid are two reactive species that may be involved in mechanisms responsible for inactivation of AFM1.

Fate of Aflatoxin M1 in Brick and Limburger-like Cheese.

Three batches of brick cheese were prepared, using milk which was naturally contaminated with aflatoxin M1 (AFM1). Cheeses were allowed to ripen with a smear for 2, 3 or 4 weeks, and then were either waxed or wrapped in foil to simulate production of mild brick, aged brick or Limburger-like cheese, respectively. These cheeses were analyzed for AFM1 at intervals for about 26 weeks. There was an average 1.7-fold enrichment of toxin in the curd over that in milk. Levels of AFM1 in cheese started low, appeared to increase at about 4 weeks of age and then dropped to initial levels in cheese ripened with a smear for 3 or 4 weeks. At no time did amounts of AFM1 drop below initial levels. Toxin concentrations appeared to increase most in the rind of cheeses ripened with a smear for 2 or 3 weeks. When such ripening was for 4 weeks, levels of AFM1 in the rind decreased, whereas levels in the center of the brick remained constant or increased.

Fate of Aflatoxin M1 in Cottage Cheese.

Two batches of long-set cottage cheese were prepared from milk naturally contaminated with aflatoxin M1. Cottage cheese was stored for 2 weeks at 7°C. Analyses for pH, moisture content and AFM1 were done on days 0, 3, 7, 10 and 14 of storage. In comparison with the initial curd concentrations (18.3 and 20.5 µ of AFM1/kg of cheese for trials 1 and 2, respectively), AFM1 concentrations in the finished product did not decrease appreciably during storage. Overall average concentrations of AFM1 in trials 1 and 2 from day 0 to day 14 were 15.0 and 20.5 µg of AFM1/kg of cheese, respectively.