Progress 01/01/03 to 06/30/07
Outputs
OUTPUTS: The first continuation of my research this year involved serving on four expert panels. These include a panel of leading international nutrition researchers convened to develop a series of five Lancet papers with recommendations for reducing undernutrition in developing countries; the Committee on School Nutrition Standards at the Institute of Medicine (IOM); an expert consultation convened by the World Health Organization to advise on the a project to undertake Landscape Analysis of national readiness to improve nutrition; and an expert consultation convened by UNICEF to advise on its five year strategy for child health and nutrition. In addition to providing scientific input into the deliberations of these three groups, in all four cases these venues provided me with an opportunity to closely observe this phase of the policy development process. These observations will assist me in developing suggestions for improving that process in the future. The second continuation of
my research on improved approaches for policy analysis and development is part of a World Bank funded project aimed at mainstreaming efforts to improve nutrition in developing countries. In this project we designed a strategy for policy development that builds on my earlier work and was implemented in Bangladesh, Vietnam, Bolivia and Peru. Finally, I led a group of researchers and practitioners from Cornell and four other organizations in preparing a pre-proposal for the Gates Foundation aimed at developing, implementing and evaluating approaches for sustainable scaling-up of nutrition actions in five countries.
PARTICIPANTS: World Health Organization, UNICEF, World Bank, Governments of Peru, Bolivia, Vietnam, BRAC/Bangladesh, Institute of Medicine, Helen Keller International, Academy for Educational Development, International Food Policy Research Institute, University of South Carolina, Johns Hopkins University.
TARGET AUDIENCES: World Health Organization, UNICEF, World Bank, Governments of Peru, Bolivia, Vietnam, BRAC/Bangladesh, Institute of Medicine, Helen Keller International, Academy for Educational Development, International Food Policy Research Institute, University of South Carolina, Johns Hopkins University.
Impacts
My involvement on the four expert panels resulted in significant improvements in the publications (Lancet series), committee report (IOM committee), approaches for conducting the Landscape Analysis (WHO) and health an nutrition strategies for children (UNICEF). My involvement in the mainstreaming nutrition initiative resulted in significant improvements in the approaches used for designing national nutrition programs in Peru and Bolivia. My involvement in the Gates pre-proposal led to the submission of that proposal to the foundation, with results yet to be determined.
Publications
- Pelletier, D.L. 2006. Theoretical Considerations Related to Cutoff Points. Food and Nutrition Bulletin 27(4)(supplement):224-236.
- Tao, M., Pelletier, D.L. and Miller, D. 2007. The Potential Effect of Iron Defortification on Iron Deficiency Anemia in the U.S. Population. Public Health Nutrition 10(11):1266-1273.
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Progress 01/01/06 to 12/31/06
Outputs
My on-going efforts to improve the approaches for policy analysis and development involved five parallel efforts in 2006. First, my research on the Food and Drug Administration's policy regarding genetically engineered foods was expanded to examine the legal and political dimensions of the policy, in addition to the scientific dimensions studied in 2004 and 2005. That work revealed that the FDA responded to political pressure for a permissive regulatory approach by exploiting gaps in scientific knowledge, creatively interpreting existing food law and limiting public involvement in the policy development. Common statements by the government and other proponents concerning sound science, rigorous testing, no evidence of harm and as safe as conventional foods were found to be misleading, unless the scientific, legal and political basis for the U.S. policy is taken into account. While the research documented that the evidence for the safety of GE foods has been
exaggerated by government agencies and other parties, the research did not uncover any evidence that genetically engineered foods currently on the market are harmful to human health. To the contrary, the situation is one of great uncertainty. Repeated recommendations that this issue be the topic of a major public research effort have yet to be acted upon. The second continuation of my research involved responding to a request from the Gates Foundation to help them develop a global nutrition strategy. I did this work in collaboration with a small team of faculty and researchers at Cornell and submitted a report to the Gates Foundation. The Foundation is expected to announce its global strategy in 2007, including a major investment of funding for nutrition programs and research in developing countries. The third continuation of my research involved serving on three expert panels. These include a panel of leading international nutrition researchers convened to develop a series of five
Lancet papers with recommendations for reducing undernutrition in developing countries; the Committee on School Nutrition Standards at the Institute of Medicine (IOM); and a panel convened by the United Nations University to advise on the development of growth standards for children and adolescents. In addition to providing scientific input into the deliberations of these three groups, in all three cases these venues provided me with an opportunity to closely observe this phase of the policy development process. These observations will assist me in developing suggestions for improving that process in the future. Finally, my research on improved approaches for policy analysis and development has continued as part of a World Bank funded project aimed at mainstreaming efforts to improve nutrition in developing countries. In the project we have designed a strategy for policy development that builds on my earlier work and is being tested in Bangladesh, Vietnam, Bolivia and Peru.
Impacts
The work this year is expected to have several significant impacts. The global nutrition strategy developed for the Gates Foundation is expected to guide major investments by the Foundation in nutrition programs and research. The Lancet series on nutrition is expected to re-energize the international community and developing countries in addressing undernutrition. The report on School Nutrition Standards will be taken up by Congress and may lead to new legislation to strengthen nutrition standards in schools. Finally, the mainstreaming nutrition project is expected to strengthen the approaches taken to reduce malnutrition in those four countries and others to be engaged in the future.
Publications
- Pelletier, D.L. 2006. Science, Law and Politics FDAs GE Foods Policy: Scientific, Legal and Political Dimensions Food Policy 31(6):570-91.
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Progress 01/01/05 to 12/31/05
Outputs
The safety of genetically engineered (GE) foods has been one of the controversial issues related to this new technology. In the U.S.the FDA is responsible for assuring that GE foods are consistent with federal laws and regulations. In developing its 1992 Statement of Policy FDA asserted that GE foods do not pose any unique hazards and could be regulated through FDAs existing authority. FDA granted GE foods the legal presumption of being Generally Recognized as Safe (GRAS) and provided developers some decision trees and guidance concerning the tests they could apply in demonstrating GRAS status. This project examined FDAs 1992 Statement in detail to ascertain the adequacy of these decision trees and tests, and the strength of the scientific evidence underlying FDAs position that GE foods pose no unique hazards. The study finds FDAs 1992 Statement was developed in the context of critical gaps in scientific knowledge concerning the compositional effects of genetic
transformation and severe limitations in methods for safety testing. FDA acknowledged that pleiotropy and insertional mutagenesis may cause unintended changes, but it was unknown whether this happens to a greater extent or with different consequences in GE compared to conventional breeding. Moreover, the agency was not able to identify methods by which producers could screen for unintended allergens and toxicants. To better understand the basis for FDAs presumption of safety for GE foods four additional sources of information were examined: a) internal FDA correspondences related to the draft 1992 policy; b) reports from the National Academies of Science; c) research funded by USDA from 1981 to 2002; and d) FDAs proposed rules issued in 2001. These sources reveal little research has been conducted on unintended compositional changes from GE and the existence of disagreement within FDA concerning the adequacy of the 1992 Statement of Policy. The possibility that GE may create more
unintended compositional changes than conventional breeding was affirmed in FDAs proposed rules in 2001, but these rules were never finalized. These findings suggest: a) statements that there is no evidence that GE foods currently on the market are harmful to human health must be evaluated in light of the nature and strength of the evidence itself and the absence of systematic post-marketing monitoring for adverse effects; b) statements that FDA has determined that GE foods currently on the market are as safe as conventional foods is an accurate statement of the legal status of GE foods; however, it not based on an extensive body of scientific evidence and rigorous testing methods. Finally, the study suggests that reassurances of safety based on reference to sound science, rigorous testing and/or overwhelming scientific evidence must be interpreted with great caution. Broad spectrum profiling techniques now could be used to assess compositional changes in GE foods but these are not
being employed and would require further research to understand the functional meaning of any observed compositional changes.
Impacts
This study is intended to help clarify several key issues related to scientific basis for FDAs regulation of GE foods, so that future policy debates and deliberations can be conducted in a more informed manner. In addition, the study highlights the need for more basic research concerning the unintended compositional changes in GE foods, in relation to conventional breeding, and the need to begin applying the powerful new techniques of molecular biology (such as broad spectrum profiling) to understand these changes. The degree to which these impacts from this research are translated into practice depends to a large extent on the willingness of land-grant universities and other parties to do so.
Publications
- Pelletier, D.L. 2005. Science, Law and Politics in FDAs Genetically Engineered Foods Policy: FDAs 1992 Policy. Nutrition Reviews 63(5):171-181.
- Pelletier, D.L. 2005. Science, Law and Politics in FDAs Genetically Engineered Foods Policy: Scientific Concerns and Uncertainties Nutrition Reviews 63(6):210-223.
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Progress 01/01/04 to 12/31/04
Outputs
The purpose of this research is to quantify the role of dietary iron in total body iron (TBI) accumulation among homozygotes for the HFE gene associated with hemochromatosis. A Monte Carlo model was built to simulate iron accumulation based on findings from human feeding experiments and national dietary surveys. A hypothetical cohort of 1000 homozygotes starting with age 25-year is used in 39-year simulations. Iron accumulation is compared under three scenarios. At baseline, there is no dietary modification. Under the second scenario, allowable food iron intake is capped at 200 percent RDA. Under the third scenario, allowable food iron intake is capped at 100 percent RDA. At baseline, by age 64, the percentages of males with TBI greater than 10g, 15g and 20g are 93.2 percent, 49.6 percent and 14.7 percent, respectively. Under the second scenario in which 55 percent of men originally had iron intakes above 200 percent RDA, the corresponding percentages are 92.0
percent, 40.5 percent and 10.2 percent respectively. Under the third scenario, in which 100 percent of men originally had iron intakes above 100 percent RDA, the corresponding percentages are 70.3 percent, 21.3 percent and 4.1 percent, respectively. The percentage of females with increased TBI is lower than males and the effect of dietary modification on iron accumulation is more modest. In conclusion, high iron intake increases the TBI accumulation among HFE homozygotes and variation in iron intake accounts for some of the incomplete penetrance in this condition.
Impacts
This research will demonstrate the need for researchers and policy analysts to use innovative methods to integrate diverse sources of information (e.g., molecular biology, human feeding trials, national dietary surveys) to evaluate policy options related to gene-nutrient interactions. Microsimulation is one such method but it is underutilized at present in nutrition.
Publications
- Pelletier, D.L. and E.A. Frongillo. 2003. Changes in Child Survival Are Strongly Associated with Changes in Malnutrition in Developing Countries. Journal of Nutrition 133:107-119.
- Pelletier, D.L., C. McCullum, V. Kraak and K. Asher. 2003. Participation, Power and Beliefs Shape Local Food and Nutrition Policy. Journal of Nutrition 133:301-304
- Sheldon, J., and D.L. Pelletier. 2003. Nutrient Intakes Among Dietary Supplement Users and Non-Users in the Food Stamps Population. Family Economics and Nutrition Review 15(2):3-14.
- Pelletier, D.L. 2005. The Science and Politics of Targeting: Who Gets What, When and How. Journal of Nutrition (in press).
- Du, Lidan, J.P. Habicht, D.L. Pelletier, G.H. Pelto. 2004. Differential Response in Efficacy Trial: Who Benefit? FASEB 2004 (Abstract No. 4640).
- Du, Lidan, D.L. Pelletier, G.H. Pelto, J.P. Habicht. 2004. Studying the Policy Community of Food Fortification in China, FASEB 2004 (Abstract No. 4713).
- Tao M, Pelletier D. 2004. Iron fortification, iron deficiency anemia and iron overload in the U.S.: a microsimulation. The FASEB Journal, 18 (4): A515.
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Progress 01/01/03 to 12/31/03
Outputs
During the project year the Cornell team provided technical assistance in participatory action research (PAR) methods for UNICEFs What Every Adolescent Has a Right to Know initiative. This initiative, to mobilize youth in taking their own actions to address factors placing them at risk for HIV, took place in thirteen countries, in Africa, Asia and Latin America and the Caribbean. Cornell staff organized and took part in training activities for twelve of these countries, provided electronic technical assistance and disseminated findings at several international conferences. The experience highlights several factors affecting the success of this approach: different stakeholder interpretations of PAR; difficulty of youth transitioning from peer educators to PAR facilitators; difficulty in reaching the most marginal groups; adult-youth power relations; control of data analysis and use by adults and their organizations; and appreciation and institutionalization of PAR
approaches by donor organizations. One of the strengths of the PAR approach is that Cornell and its partners were able to identify and begin addressing each of these factors in real time as they occurred.
Impacts
Increase in ability of youth to address HIV in their own communities and ability for youth to network more effectively with organizations that can assist in this effort.
Publications
- No publications reported this period
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