The Origin of the USDA Regional Biomass Research Centers

The U.S. Department of Agriculture (USDA) Regional Biomass Research Centers (RBRC) were created to contribute to the planning, research, and development of entire long-term sustainable biofuel production supply chains based on agricultural and forest-based feedstocks. The intent of the centers is to provide a catalyst that links feedstock genetic development, sustainable production and management, logistics, conversion, co-product production, distribution, and market demand suited to the available economic, social, and natural resources within different regions. The centers provide a coordinated, region-based research focus designed with relatively short-term deliverables to help accelerate the commercial production of biomass and other biofuel feedstocks. The centers provide a leadership structure for coordinating biomass research across the country, providing a national perspective that complements other USDA agency efforts designed to help US rural communities participate in the emerging biofuels and biobased products economy. Through coordination with the RBRC, USDA research and service agency programs and resources have been leveraged with the U.S. Department of Energy (DOE) and other federal department, university, and private industry efforts to help accelerate commercial advancement of advanced biofuel production to promote rural economic opportunities and achieve transportation biofuel policy goals.     

Incentives for biodefense countermeasure development

Therapeutics and vaccines are available for only a fraction of biological threats, leaving populations vulnerable to attacks involving biological weapons. Existing U.S. policies to accelerate commercial development of biodefense products have thus far induced insufficient investment by the biopharmaceutical industry. In this article, we examine the technical, regulatory, and market risks associated with countermeasure development and review existing and proposed federal incentives to increase industrial investment. We conclude with several recommendations. To increase industry's engagement in biodefense countermeasure development, Congress should expand BioShield funding, giving HHS the flexibility to fund a portfolio of biodefense countermeasures whose revenues are comparable to those of commercial drugs. Congress should establish tradable priority review vouchers for developers of new countermeasures. A National Academy of Sciences or National Biodefense Science Board should formally evaluate incentive programs and a government-managed "Virtual Pharma," in which HHS contracts separate stages of research, development, and production to individual firms.     

Chemicals from alternative feedstocks in the United States

Abstract: Growing industrial interest in products from renewable alternative feedstocks has resulted in the creation of more industry-led federal research and development programs. The basis of this interest is introduced, followed by an overview of the various federal programs that support basic through applied research relevant to chemical products from renewable resources, and evidence of the increased coordination efforts between programs. The majority of the paper outlines a new program within the U.S. Department of Energy, the Alternative Feedstocks Program, which specifically targets chemicals from renewables which have the potential to become part of the next generation of high-volume chemical feedstocks for the manufacturing industries. The first product of the program, an iterative process technology decision analysis tool, is broadly presented using the first process development project: succinic acid from fermentable sugars.     

Agroterrorism in the U.S.: key security challenge for the 21st century

Agriculture is one of the easiest sectors of the U.S. economy to disrupt, and its disruption could have catastrophic consequences for the U.S. and world economies. Agriculture in the U.S. accounts for 13% of the current Gross Domestic Product (GDP) and provides employment for 15% of the population. It produces high-quality, cheap, plentiful food for domestic consumption and accounts for more than $50 billion in exports. The likelihood of terrorist acts interrupting the production, processing, and distribution of agricultural products is high: A number of different possible plant or animal pathogens could cause harm or loss of production, and even an act of agroterrorism that did not result in the destruction of foodstuffs or interruptions in the food supply could have a psychological impact. A number of recent unintentional events and epidemics have prompted the U.S. and other countries to provide resources to counteract contagious diseases and contain their impact, including increased funding to federal agencies that are responsible for protecting domestic agriculture. This article presents recommendations to protect agriculture, including changing the way agriculture is viewed on the federal level and increasing the resources to protect agriculture from terrorist attack.     

Billions for biodefense: federal agency biodefense funding, FY2007-FY2008

Since 2001, the U.S. government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series analyzed civilian biodefense funding by the federal government from fiscal years 2001 through 2007. This article updates those figures with budgeted amounts for fiscal year 2008, specifically analyzing the budgets and allocations for biodefense at the Department of Health and Human Services, the Department of Homeland Security, the Department of Defense, the Department of Agriculture, the Environmental Protection Agency, the Department of State, and the National Science Foundation.     

The endless hESC controversy in the United States: history, context, and prospects

Human embryonic stem cell research has faced a long, tough political battle in the United States. The article explores the history of this controversy and the motives behind it, leading up to the August 23, 2010 district court injunction temporarily stopping all U.S. federal funding for research with human ESCs.     

Best Practices for Core Facilities: Handling External Customers

This article addresses the growing interest among U.S. scientific organizations and federal funding agencies in strengthening research partnerships between American universities and the private sector. It outlines how core facilities at universities can contribute to this partnership by offering services and access to high-end instrumentation to both nonprofit organizations and commercial organizations. We describe institutional policies (best practices) and procedures (terms and conditions) that are essential for facilitating and enabling such partnerships. In addition, we provide an overview of the relevant federal regulations that apply to external use of academic core facilities and offer a set of guidelines for handling them. We conclude by encouraging directors and managers of core facilities to work with the relevant organizational offices to promote and nurture such partnerships. If handled appropriately, we believe such partnerships can be a win-win situation for both organizations that will support research and bolster the American economy.     

Federal communication about obesity in the Dietary Guidelines and checkoff programs

The new Dietary Guidelines for Americans focus on obesity prevention. They recommend increased consumption of whole grains, fruits, vegetables, fish, and low-fat dairy products, within a balanced diet whose total calories have been moderately reduced. Meanwhile, other well-known and well-funded federally sponsored consumer communications promote increased total consumption of beef, pork, and dairy products, including energy dense foods such as bacon cheeseburgers, barbecue pork ribs, pizza, and butter. These latter communications are sponsored by the federal government's commodity promotion programs, known as "checkoff" programs. The programs are established by Congress, approved by a majority of the commodity's producers, managed jointly by a producer board and the U.S. Department of Agriculture, and funded through a tax on the producers. The federal government enforces the collection of more than 600 million US dollars annually in mandatory assessments, approves the advertising and marketing programs, and defends checkoff communication in court as the federal government's own message-in legal jargon, as its own "government speech." Federal support for promoting fruits and vegetables is small by comparison. The checkoff programs recently have become more clearly identified as federal programs. After a recent decision by the U.S. Supreme Court upholding the constitutionality of the checkoff programs, calls for consistency with the Dietary Guidelines may get louder. The current inconsistencies in federal communication undermine the effectiveness of the Dietary Guidelines as an antidote to the shortcomings of the private sector market for information about weight and obesity.     

Drumming up dollars for stem cell research

With stringent U.S. federal restrictions on funding for human embryonic stem cell research still in place, states grapple with the issue of whether to fund such research themselves.     

Regulatory considerations for marker vaccines and diagnostic tests in the U.S.

Marker vaccines and diagnostic tests can prove to be invaluable in disease eradication and control programs, as was found in the pseudorabies (Aujeszky's Disease) virus eradication program in the U.S. During that campaign, numerous gene-deleted vaccines and companion diagnostic test kits were used to differentiate infected animals from vaccinated animals, in a strategy that ultimately led to eradication of the disease in commercial swine herds. The United States Department of Agriculture played a key role in delivery of that success by developing biologics policy, evaluating each product, and ensuring that the conditions of licensure were met. What was most critical in the overall eradication effort, however, was the detailed and dedicated interaction among key players: the biologics regulators, manufacturers, Federal, State, and local regulatory partners, veterinary researchers, industry associations, and animal owners. A good disease control program has to include all of these. The regulatory requirements for licensure of marker vaccines and diagnostic test kits are not different from that for other products. There are several mechanisms for vaccine approval, some more rapid than others, but only a few that could apply to these products. Generally, the platforms that might support marker vaccines and companion diagnostic kits are those based on genetic engineering or protein manipulation. If the product is derived from the application of biotechnology, then additional regulatory considerations are applicable. Most important of these are the considerations found in the National Environmental Policy Act (NEPA), wherein deliberate release of any organism containing recombinant DNA into the environment is subject to review and approval by appropriate federal agencies. Environmental release and NEPA compliance are discussed.     

E3LSI research: an essential element of biodefense

The threat of bioterrorism has prompted the U.S. to undertake a vast biodefense initiative, including funding biodefense-related scientific research at unprecedented levels. Unfortunately, the many ethical, economic, environmental, legal, and social implications (E(3)LSI) of biodefense research and activities are not yet receiving the attention they warrant. Previously, in laudable demonstrations of foresight and responsibility, the federal government has funded research into the E(3)LSI of other recent scientific endeavors--namely, the Human Genome Project and the nanotechnology research program--through directed appropriations from their respective research budgets. This article advocates and proposes a model for a portion of biodefense funding to be similarly set aside for an E(3)LSI research program to complement biodefense research, to ensure that bioterror preparedness does not give rise to harmful or otherwise undesirable unintended consequences.     

Funding priorities in animal reproduction at the United States Department of Agriculture's Cooperative State Research, Education, and Extension Service

The National Research Initiative (NRI) Competitive Grants Program is the U.S. Department of Agriculture's major competitive grants program and is administered by the Cooperative State Research, Education, and Extension Service (CSREES). Since its inception in 1991, the NRI has funded competitive grants in the discipline of animal reproduction. Previously, this program provided funding for a broad range of projects encompassing almost every subdiscipline in reproductive biology of farm animals, including aquatic species important to the aquaculture industry. During fiscal year 2004, the NRI Animal Reproduction Program narrowed the focus of funding priorities to the topics of infertility, basic mechanisms regulating fertility, cryopreservation of gametes, reducing the postpartum interval to conception, and sterilization methods or development of monosex populations. In response to a directive to further narrow the focus of funding priorities for fiscal year 2005 and beyond, CSREES conducted a Stakeholder Workshop on Funding Priorities in Animal Reproduction at the 37th Annual Meeting of the Society for the Study of Reproduction in Vancouver, Canada. More than 75 stakeholder scientists from a cross section of federal, public, and private institutions from across the United States participated in the workshop and provided recommendations to CSREES for future NRI-funding priorities in Animal Reproduction. The recommendations provided by stakeholders included continuing efforts to focus funding priorities into fewer high-impact areas relevant to animal agriculture and aquaculture. Recommendations also included movement back toward subdisciplines of animal reproduction that cut across all applicable species. The three funding priorities that consistently emerged as recommendations from the workshop participants were 1) gonadal function and production of gametes, 2) pituitary-hypothalamic function, and 3) embryo and conceptus development, including interaction between the conceptus and uterus. These funding priorities were considered when preparing the fiscal year 2006 NRI Request for Applications.     

Legal regimes for seabed hard mineral mining: Evolution at the federal and state levels

Abstract

During the last decade U.S. government and industry interest in seabed hard minerals has shifted from areas beyond national jurisdiction to those within national jurisdiction. A variety of factors—technical, economic, political, legal—are behind this trend. This article focuses on the legal aspects of federal and state efforts to encourage and regulate seabed minerals exploration activities, prospective avoidance of conflicts between seabed mining and other ocean uses, federal‐state relations in seabed minerals development, and the special situation of mineral deposits spanning the federal‐state boundary offshore.     

U.S. medical countermeasure development since 2001: a long way yet to go

The U.S. government has taken significant steps toward developing and acquiring vaccines, drugs, and other medical countermeasures (MCMs) to protect and treat the population after a biological attack. In contrast to 2001, there is now a procedure for the Department of Health and Human Services (HHS) to develop, license, and stockpile MCMs for civilian use. Another major accomplishment is smallpox preparedness: There is now an adequate supply of vaccine for every person in the U.S., and there is an alternative vaccine meant for immunocompromised people and those with close contact with them. In spite of these and other accomplishments, the U.S. government MCM effort has been criticized by federal advisory committees, National Academy of Sciences reports, a congressional commission, and outside analysts who state that the efforts lack central leadership and accountability and that the pace of progress has been slow. A clear operational strategy for using MCMs, which would guide their development and acquisition, is also lacking. In this article, we review key areas of progress made since 2001 to develop and acquire MCMs, and we summarize what we judge to be the most critical and often mentioned areas where improvements are needed.     

Local IRBs vs. Federal Agencies: Shifting Dynamics, Systems, and Relationships

how IRBs relate to federal agencies, and the implications of these relationships, have received little, if any, systematic study. I interviewed 46 IRB chairs, directors, administrators, and members, contacting the leadership of 60 U.S. IRBs (every fourth one in the list of the top 240 institutions by NIH funding), interviewing IRB leaders from 34 (response rate=55%). IRBs describe complex direct and indirect relationships with federal agencies that affect IRBs through audits, guidance documents, and other communications, and can generate problems and challenges. Researchers often blame IRBs for frustrations, but IRBs often serve as the "local face" of federal regulations and agencies and are "stuck in the middle." These data have critical implications for policy, practice, and research.     

Industry's challenge to academia: changing the bench to bedside paradigm

The need for interdisciplinary collaboration is arising as a result of accelerating advances in basic science, including massive research and development funding by both government and industry, which has spurred the so-called "nanotechnology revolution" and developments at the intersection of the life and physical sciences, increasing emphasis by federal research funding agencies on interdisciplinary and inter-institutional research and by market influences. A number of barriers presently limit the interaction between academics and industry, including the typically very time-consuming and slow pace of technology transfer, which is compounded in the case of interdisciplinary and inter-institutional licensing, as well as the natural, and understandable, antipathies that exist between academia and industry as a result of their differing missions and approaches to scientific discovery. Moreover, if mechanisms are not in place at the outset of an inter-university collaboration, then the transition of inventions to clinical applications can be fraught with additional complexities and barriers. Policies suggested by the National Nanotechnology Initiative offer a number of ideas for overcoming barriers to multidisciplinary and inter-institutional research and illustrate some of the ways in which academia can structure partnerships with industry that will not only provide needed funding for multidisciplinary and inter-institutional biomedical research in an era of diminishing federal resources, but may permit academia, on the one hand, and industry, on the other, to benefit from the strengths provided by the other without compromising either academia's or industry's basic missions.     

Study of submerged aquatic vascular plants in Northern Glacial Lakes (New York State,U.S.A.)

The submerged aquatic vascular vegetation was studied in the Finger Lakes and in two bays of Lake Ontario in northern New York State, U.S.A. The species composition, structure and biomass of the communities are related to the principal habitat factors such as trophic status of the lakes, bottom slope and substrate, current and stream effects, and depth. A record of the development of changes in the trophic status of the lakes and in the species composition of their submerged vascular vegetation is outlined. An attempt is made to assess the effects of catastrophic events (floods and cloudbursts in the watershed) on the lake vegetation.     

Can there be fair funding for fundholding practices?

Most regional health authorities set budgets for fundholding practices according to the amount of care used by the practice population. This article explains why this funding method can only lead to an inequitable allocation of resources between fundholding and non-fundholding practices. Using the experience of North West Thames region, the efforts made to make funding fairer are discussed. The steps that health authorities could take to investigate and reduce the problem are also outlined. In the absence of a capitation formula for funding fundholding practices, the paper suggests that health authorities should do much more to investigate the amount of money they spend on non-fundholding practices. Regions could develop and use other methods to set budgets rather than rely on activity recorded by practices. Regions and the Department of Health should resolve urgently if and how far the budgets for fundholders should be compensated for increases in provider prices.     

食品添加剂研究现状及发展趋势

近年来食品添加剂的研究主要集中在新型安全的天然食品添加剂研究、食品添加剂制备中的新技术研究和食品添加剂的检测分析技术研究三个方面。本文概述了我国食品添加剂的现状、发展趋势及该领域的研究热点问题。同时对这两年国家自然科学基金委员会（以下简称基金委）在食品科学学科食品添加剂分支学科资助情况进行了分析,在基金申请中新型天然食品添加剂的研究受关注度较高,而利用生物技术制备天然食品添加剂这一研究热点在今年的申请和资助项目中也有体现。基金委在食品添加剂这一分支学科的资助体现了目前食品添加剂发展的趋势。     

Billions for biodefense: Federal Agency biodefense funding, FY2006-FY2007

Since 2001, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. Earlier articles in this series analyzed the civilian biodefense funding by the federal government from fiscal years 2001 through 2006. This article updates those figures with budgeted amounts for fiscal year 2007, specifically analyzing the budgets and allocations for biodefense at the Department of Health and Human Services, the Department of Homeland Security, the Department of Agriculture, the Environmental Protection Agency, the Department of State, and the National Science Foundation.