Transgenesis in Animal Agriculture: Addressing Animal Health and Welfare Concerns

The US Food and Drug Administration??s final Guidance for Industry on the regulation of transgenesis in animal agriculture has paved the way for the commercialization of genetically engineered (GE) farm animals. The production-related diseases associated with extant breeding technologies are reviewed, as well as the predictable welfare consequences of continued emphasis on prolificacy at the potential expense of physical fitness. Areas in which biotechnology could be used to improve the welfare of animals while maintaining profitability are explored along with regulatory schema to improve agency integration in GE animal oversight.     

Sustainable Use of Biotechnology for Bioenergy Feedstocks

Done correctly, cellulosic bioenergy should be both environmentally and economically beneficial. Carbon sequestration and decreased fossil fuel use are both worthy goals in developing next-generation biofuels. We believe that biotechnology will be needed to significantly improve yield and digestibility of dedicated perennial herbaceous biomass feedstocks, such as switchgrass and Miscanthus, which are native to the US and China, respectively. This Forum discusses the sustainability of herbaceous feedstocks relative to the regulation of biotechnology with regards to likely genetically engineered traits. The Forum focuses on two prominent countries wishing to develop their bioeconomies: the US and China. These two countries also share a political desire and regulatory frameworks to enable the commercialization and wide release of transgenic feedstocks with appropriate and safe new genetics. In recent years, regulators in both countries perform regular inspections of transgenic field releases and seriously consider compliance issues, even though the US framework is considered to be more mature and stringent. Transgene flow continues to be a pertinent environmental and regulatory issue with regards to transgenic plants. This concern is largely driven by consumer issues and ecological uncertainties. Regulators are concerned about large-scale releases of transgenic crops that have sexually compatible crops or wild relatives that can stably harbor transgenes via hybridization and introgression. Therefore, prior to the commercialization or extensive field testing of transgenic bioenergy feedstocks, we recommend that mechanisms that ensure biocontainment of transgenes be instituted, especially for perennial grasses. A cautionary case study will be presented in which a plant’s biology and ecology conspired against regulatory constraints in a non-biomass crop perennial grass (creeping bentgrass, Agrostis stolonifera), in which biocontainment was not attained. Appropriate technologies that could be applied to perennial grass feedstocks for biocontainment are discussed.     

Commercialization of Perennial GE Crops: Looming Challenges for Regulatory Frameworks

Overall, the deregulation of genetically engineered (GE) crops for commercial cultivation in North America has been a success story. In several cases, however, GE crops have sparked concerns and disagreements among the stakeholders and there are incidences of court lawsuits, including a recent one on glyphosate resistant (GR) alfalfa (Medicago sativa, L.). While GE crops can provide operational benefits to farmers, challenges are looming from commercialization of perennial GE crops. The unique ecology and biology of these crops and GE alfalfa in particular can facilitate adventitious presence (AP) of GE traits and it makes more visible that economic risks for conventional growers and food/feed producers have not been adequately addressed by the GE regulatory system in the United States (US). Asynchronous market approvals and the existence of a number of GE sensitive export markets create uncertainties among the exporters. Policy development in these fields may be helpful for ensuring a broader acceptance and market success of GE agriculture in general. The analysis is focusing on the US, although many diagnosed problems are also relevant to other jurisdictions—in particular if no co-existence policy is in place.     

Do Regulators of Animal Welfare Need to Develop a Theory of Psychological Well-Being?

The quest for a ``theory of nonhuman minds' to assessclaims about the moral status of animals is misguided. Misframedquestions about animal minds facilitate the appropriation ofanimal welfare by the animal user industry. When misframed, thesequestions shift the burden of proof unreasonably to animalwelfare regulators. An illustrative instance of misframing can befound in the US National Research Council's 1998 publication thatreports professional efforts to define the psychologicalwell-being of nonhuman primates, a condition that the US 1985animal welfare act requires users of primates to promote. Thereport claims that ``psychological well-being' is a hypotheticalconstruct whose validity can only be determined by a theory thatdefines its properties and links it to observed data. Thisconception is used to contest common knowledge about animalwelfare by treating psychological well-being as a mentalcondition whose properties are difficult to discover. Thisframework limits regulatory efforts to treat animal subjects lessoppressively and serves the interests of the user industry.A more liberatory framework can be constructed by recognizing thecontested nature of welfare norms, where competing conceptions ofanimal welfare have implications about norm-setting authority, asit does in other regulatory contexts, e.g., food safety. Properlyconceptualized welfare should include both the avoidance ofdistressful circumstances and the relationship between ananimal's capacities to engage in enjoyable activities and itsopportunities to exercise these capacities. This conception ofanimal welfare avoids appropriation by scientific experts.The development of the psychological well-being regulation is agood illustration of how social norms are contested and thenappropriated, and a critique of this appropriation shows how itcan be challenged.     

She Came, She Saw, She Sowed: Re-negotiating Gender-Responsive Priorities for Effective Development of Agricultural Biotechnology in Sub-Saharan Africa

In this paper, we argue for the importance of incorporating a gendered perspective for the effective development of sustainable agricultural biotechnology systems in sub-Saharan Africa. Priority setting for agricultural policy and project development requires attention to gender issues specific to the demands of agricultural biotechnology. This is essential for successfully addressing food security and poverty reduction in sub-Saharan Africa (SSA). There has been a great deal of debate and literature on the implications of gender in agricultural development and policy. However, the implications of gender in agricultural biotechnology and have received relatively less attention, especially in SSA. Based on interviews with key stakeholders in agricultural biotechnology across SSA, review of pertinent literature and field observations, we have found that incorporating a gendered perspective is critical for the sustainable development of agricultural biotechnology and requires attention in five areas: the inclusion of women, particularly women farmers, in decision-making around biotech/genetically modified (GM) crop and trait selection; equal representation of women as men in education for agricultural science and in agricultural biotechnology research and development professions; greater involvement of women in extension services and farmers’ associations for successful delivery of information about biotech crops equality between men and women in access to resources for biotech/GM crop cultivation; and increased control for women farmers over biotech/GM crop management and income generation. We explain the consequences of failing to include such gender-responsive considerations into priority setting for agricultural biotechnology development and policy in SSA and provide recommendations for how policy makers and project partners of development initiatives can avoid such oversights.     

The transatlantic rift in genetically modified food policy

The regulatory structures underlying United States and European Union policies regarding genetically modified (GM) food and crops are fundamentally different. The US regulates GM foods and crops as end products, applying roughly the same regulatory framework that it does to non GM foods or crops. The EU, on the other hand, regulates products of agricultural biotechnology as the result of a specific production process. Accordingly, it has developed a network of rules that regulate GM foods and crops specifically. As a result, US regulation of GM foods and crops is relatively permissive, whereas EU regulation is relatively restrictive. Why are genetically modified food policies in the United States and the European Union so strikingly different? In the light of the recent World Trade Organization dispute on agricultural biotechnology, it may seem that economic interests are the driving force behind policies. While they are certainly part of the picture, the issue is far more complex. This paper argues that three different elements help explain differences between US and EU GM food policies. First, an investigation of US and European policies of the 1970s and 1980s on recombinant DNA research and of events leading up to early GM food and crop regulation allows a deeper understanding of current policy. Second, scrutinizing underlying values and norms can uncover the beliefs that condition current GM food and crop policy. Third, an analysis of involved actors’ views and levels of success in influencing policy is essential to understanding US and EU policies.     

The Wild Animal as a Research Animal

Most discussions on animal experimentation refer to domesticated animals and regulations are tailored to this class of animals. However, wild animals are also used for research, e.g., in biological field research that is often directed to fundamental ecological-evolutionary questions or to conservation goals. There are several differences between domesticated and wild animals that are relevant for evaluation of the acceptability of animal experiments. Biological features of wild animals are often more critical as compared with domesticated animals because of their survival effects. An important issue is what is called here “natural suffering”: the suffering from natural circumstances. Should this type of suffering be taken into account when suffering from experimentation is evaluated? As an answer, it is suggested that ``natural functioning'' should be considered as an additional standard in the evaluation of wild animal experimentation. Finally, two topics related to the ecological context are considered. Firstly, the often inevitable involvement of non-research animals in wild animal experimentation, and secondly, the eco-centric approach to nature conservation. According to the latter position, animals are subordinated to ecosystems. All these aspects make the evaluation of wild animal experiments much more complex than experiments with domesticated animals. Preliminary scores are proposed to deal with these aspects. It is argued that this should not lead to a more complex governmental regulation, since an effective maintenance and control are hard to realize and one may loose the cooperation of researchers themselves. In addition, non-governmental professional organizations such as research societies and funding organizations play a pivotal role.     

Animal Agriculture: Symbiosis, Culture, or Ethical Conflict?

Several writers on animal ethics defend the abolition of most or all animal agriculture, which they consider an unethical exploitation of sentient non-human animals. However, animal agriculture can also be seen as a co-evolution over thousands of years, that has affected biology and behavior on the one hand, and quality of life of humans and domestic animals on the other. Furthermore, animals are important in sustainable agriculture. They can increase efficiency by their ability to transform materials unsuitable for human consumption and by grazing areas that would be difficult to harvest otherwise. Grazing of natural pastures is essential for the pastoral landscape, an important habitat for wild flora and fauna and much valued by humans for its aesthetic value. Thus it seems that the environment gains substantially when animals are included in sustainable agricultural systems. But what about the animals themselves? Objections against animal agriculture often refer to the disrespect for animals’ lives, integrity, and welfare in present intensive animal production systems. Of the three issues at stake, neither integrity nor animal welfare need in principle be violated in carefully designed animal husbandry systems. The main ethical conflict seems to lie in the killing of animals, which is inevitable if the system is to deliver animal products. In this paper, we present the benefits and costs to humans and animals of including animals in sustainable agriculture, and discuss how to address some of the ethical issues involved.     

The Peconic River: Concerns associated with different risk evaluations for fish consumption

Risk evaluation and assessment have been used as tools to regulate and manage the risks to consumers of eating self-caught fish that have high levels of contaminants. Armed with these risk assessments, health agencies issue consumption advisories, and in some cases, close some waters to fishing. Recently, regulatory agencies have used contaminant levels in fish as a benchmark for remedial action on contaminated sites, using human health risk assessment as the justification. The US Environmental Protection Agency's new surface water criterion for mercury is based on mercury levels in fish tissue. When multiple regulatory agencies have jurisdiction over the same waters or remediation site there is the potential for differing risk evaluations. Using the Peconic River on Long Island, New York as a case study, the paper examines how and why county, state, and federal health risk evaluations for fish contaminated with mercury differed. While the same risk methodology was applied by all agencies, the assessments were conducted for different purposes, applied different consumption and fish biomass assumptions, and arrived at different conclusions. The risk evaluations invoked to design fish consumption advisories use mercury levels currently in fish, and are designed to prevent current exposure. However, the risk assessments that provide a basis for remediation consider many different pathways of exposure (not just ingestion), and deal with long-term exposure. The risk evaluations, and recommendations promulgated by those agencies, differ because they have different goals, use different assumptions, and often fail to communicate among agencies. It is suggested that it is valuable to have these different levels of risk evaluations to adequately address health issues. However, there are policy implications, which include making the distinctions between the types of risk assessments, their methods and assumptions, and the rationale for these assumptions. Further, assessors and managers should involve all interested stakeholders (including regulators and state health officials) in discussions about the use of risk, the assumptions of risk assessment, and the goals of those evaluations. The difficulties in the case of the Peconic were not due to differences in the original data, but rather in the goals and type of risk assessments performed. If all deliberations had been transparent during all phases of the decision-making and management process, the conflicts within the minds of the public, regulators and other agencies might have been avoided. This case study suggests that more reliability, circumspection and transparency should be built into the process where multiple agencies and multiple objectives are involved.     

Regulatory aspects

Summary At this time, there is no US legislation that is specifically aimed at regulating the environmental release of genetically engineered organisms or their modified components, either during the research and development stage or during application. There are some statutes, administered by several federal agencies, whose language is broad enough to allow the extension of intended coverage to include certain aspects of biotechnology. The one possible exception is FIFRA, which has already brought about the registration of several natural microbial pesticides but which also has provision for requiring the registration of strain improved microbial pesticides. Nevertheless, there may be gaps in coverage even if all pertinent statutes were to be actively applied to the control of environmental release of genetically modified substances. The decision to regulate biotechnology under TSCA was justified, in part, on the basis of its intended role as a gap-filling piece of environmental legislation. The advantage of regulating biotechnology under TSCA is that this statute, unlike others, is concerned with all media of exposure (air, water, soil, sediment, biota) that may pose health and environmental hazards. Experience may show that extending existing legislation to regulate biotechnology is a poor compromise compared to the promulgation of new legislation specifically designed for this purpose. It appears that many other countries are ultimately going to take the latter course to regulate biotechnology.     

Conservation Considerations for a Management Measure: An Integrated Approach to Hare Rearing and Release

Wildlife managers are challenged with the task of deciding whether a management measure is appropriate or not, and furthermore they have to convince others about the merits of their decision. Population decline of some hare species (genus Lepus) has resulted in their Red Listing and conservation measures are being undertaken. Release or restocking is a frequent measure in some countries, and thousands of hares are released annually, mainly for hunting purposes. These hares can be obtained by either intensive or extensive rearing or translocation of the wild animals. Each method entails difficulties and different survival rates in the wild. Survival rates in the wild are low for hares intensively reared in cages but are higher for hares reared extensively in enclosures and wild translocated hares. The benefits of the hare release practice are significantly lower than the action’s implementation cost. Hare releases have not increased significantly the wild hare population or the hunting harvest in areas where the practice has been applied. The risk of genetic and evolutionary degradation and pathogen transmission is possible in wild populations. The need for wise management of this practice is evident and the term ‘Permitted Transferring Units’ should be introduced to denote regions where hares should not be transferred for rearing and release.     

Science, Policy, Stakeholders, and Fish Consumption Advisories: Developing a Fish Fact Sheet for the Savannah River

In recent years there has been a startling rise in the issuance of fish consumption advisories. Unfortunately, compliance by the public is often low. Low compliance can be due to a number of factors, including confusion over the meaning of advisories, conflicting advisories issued by different agencies, controversies involving health benefits versus the risks from consuming fish, and an unwillingness to act on the advisories because of personal beliefs. In some places, such as along the Savannah River, one state (South Carolina) had issued a consumption advisory while the other (Georgia) had not, although at present, both states now issue consumption advisories for the Savannah River. Herein we report on the development of a fish fact sheet to address the confusing and conflicting information available to the public about consuming fish from the Savannah River. The process involved interviewing fishers to ascertain fishing and consumption patterns, evaluating contaminant levels and exposure pathways, discussing common grounds for the provision of information, and consensus-building among different regulatory agencies (US Environmental Protection Agency, South Carolina Department of Health and Environmental Control, Georgia Department of Natural Resources) and the Department of Energy. Consensus, a key ingredient in solving many different types of “commons” problems, was aided by an outside organization, the Consortium for Risk Evaluation with Stakeholder Participation (CRESP). The initial role for CRESP was to offer scientific data as a basis for groups with different assumptions about risks to reach agreement on a regulatory response action. The process was an example of how credible science can be used to implement management and policies and provide a basis for consensus-building on difficult risk communication issues. The paper provides several lessons for improving the risk process from stakeholder conflicts, through risk assessment, to risk management. It also suggests that consensus-building and risk communication are continuing processes that involve assimilation of new information on contaminants and food-chain processes, state and federal law, public policy, and public response.     

Animal Welfare Impact Assessments: A Good Way of Giving the Affected Animals a Voice When Trying to Tackle Wild Animal Controversies?

Control of wild animals may give rise to controversy, as is seen in the case of badger control to manage TB in cattle in the UK. However, it is striking that concerns about the potential suffering of the affected animals themselves are often given little attention or completely ignored in policies aimed at dealing with wild animals. McCulloch and Reiss argue that this could be remedied by means of a “mandatory application of formal and systematic Animal Welfare Impact Assessment (AWIA)”. Optimistically, they consider that an AWIA could help to resolve controversies involving wild animals. The aim of this paper is to evaluate the potential of AWIA. We begin by showing how ideas akin to AWIA already play a significant role in other animal ethics controversies, particularly those concerning laboratory animal use and livestock production; and we bring in lessons learnt from these controversies. Then we comment on the suggested development and application of AWIA in the case of badger control. Finally, we discuss the prospects of applying AWIA to other sorts of wild animal controversy. We argue that the AIWA, as developed by McCulloch and Reiss, relies on several dubious premises, including that killing is a welfare issue. Furthermore, we argue that AWIA is unlikely to prevent serious moral disagreements over how to weigh concerns about wild animals against priorities in human health, the health of domestic and farm animals, and biodiversity, but that it may nonetheless serve to limit harms imposed on the wild animals.     

The “Revolving Door” between Regulatory Agencies and Industry: A Problem That Requires Reconceptualizing Objectivity

There is a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at least three ethical and policy challenges that have to do with public trust and fair representation. First, the presence of former key industry personnel on review boards could adversely impact the public’s confidence in regulatory decisions about new technology products, including agrifood biotechnologies. Second, the ‘‘revolving door’’ may result in policy decisions about technologies that are biased in favor of industry interests. And third, the ‘‘revolving door’’ virtually guarantees industry a voice in the policy-making process, even though other stakeholders have no assurance that their concerns will be addressed by regulatory agencies. We believe these three problems indicate a failure of regulatory review for new technologies. The review process lacks credibility because, at the very least, it is procedurally biased in favor of industry interests. We argue that prohibiting the flow of personnel between regulatory agencies and industry would not be a satisfactory solution to the three problems of public trust and just representation. To address them, regulatory entities must reject the traditional notion of objectivity. Instead they should adopt the conception of objectivity developed by Sandra Harding and re-configure their regulatory review on the basis of it. That will ensure that a heterogeneous group of stakeholders is at the decision-making table. The fair representation of interests of different constituencies in the review process could do much to inspire warranted public confidence in regulatory protocols and decisions.     

Risk assessment methodologies for biotechnology impact assessment

Summary By combining hazard assessment of effects of a potential biotechnology product with exposure assessments based on study of the genetically engineered organism's fate, conclusions may be reached about the risk involved in release of the product to the environment. In order to make this risk assessment, criteria (including regulatory endpoints) must be established and then developed further against a data base from well-accepted tests. Other aspects requiring research and development include test evaluation, quality assurance, statistical procedures, and methods of identifying and monitoring not only the nominal organism(s) in the products, but also any contaminating material or organisms to which the genetically engineered components may be transferred in the environment.Application of microcosm technology to testing of genetically engineered organisms is expected to be important, since these systems may be used safely to understand fate and effects prior to (or in place of) testing the product in the environment. Limitations in the use of microcosms may be offset by the cost-effectiveness and incisiveness of results, as has been shown for other pollutants.Risk management for biotechnology products currently lacks an adequate background, but components of the process exist or can be developed. New resources, in terms of personnel, training, facilities, and funding, will be needed in order to apply the risk assessment paradigm used for toxic chemicals and pesticides. We will need to know:     

Consumer Attitudes Towards the Development of Animal-Friendly Husbandry Systems

Recent policy developments in the area of livestock husbandry have suggested that, from the perspective of optimizing animal welfare, new animal husbandry systems should be developed that provide opportunities for livestock animals to be raised in environments where they are permitted to engage in “natural behavior.” It is not known whether consumers regard animal husbandry issues as important, and whether they differentiate between animal husbandry and other animal welfare issues. The responsibility for the development of such systems is allocated jointly between farmers, regulators, different actors in the food chain, and consumers. This research focuses on understanding consumer attitudes and preferences regarding the development and introduction of such systems, to ensure that they are acceptable to consumers as well as producers, regulators, and scientists. Consumer perceptions of animal welfare and animal husbandry practices were evaluated using quantitative consumer survey, which focused on two animal husbandry issues – farmed pigs and farmed fish. Following pilot work, 1000 representative Dutch consumers were sampled about their attitudes to either pig or fish husbandry. The results indicated that consumers think about animal welfare in terms of two broad categories related to their health and living environment, but do not think about welfare issues at a more detailed level. Greater concern was expressed about the welfare of pigs compared to fish. Consumer trust in labeling also emerged as an important issue, since consumers need to trust different food chain actors with responsibility for promoting animal welfare, and are reluctant to consider the details of animal husbandry systems. As a consequence, a transparent, enforceable, and traceable monitoring system for animal welfare friendly products is likely to be important for consumers.     

Ethical Veganism,Virtue, and Greatness of the Soul

Many moral philosophers have criticized intensive animal farming because it can be harmful to the environment, it causes pain and misery to a large number of animals, and furthermore eating meat and animal-based products can be unhealthful. The issue of industrially farmed animals has become one of the most pressing ethical questions of our time. On the one hand, utilitarians have argued that we should become vegetarians or vegans because the practices of raising animals for food are immoral since they minimize the overall happiness. Deontologists, on the other hand, have argued that the practices of raising animals for food are immoral because animals have certain rights and we have duties toward them. Some virtue ethicists remain unconvinced of deontic and consequentialist arguments against the exploitation of animals and suggest that a virtue-based approach is better equipped to show what is immoral about raising and using animals for food, and what is virtuous about ethical veganism.     

Contamination, Crop Trials, and Compatibility

This paper examines the ethical andsocial questions that underlie the present UKdiscussion whether GM crops and organicagriculture can co-exist within a given regionor are mutually exclusive. A EuropeanCommission report predicted practicaldifficulties in achieving sufficientseparation distances to guarantee lowerthreshold levels proposed for GM material inorganic produce. Evidence of gene flow betweensome crops and their wild relatives has beena key issue in the recent Government consultation toconsult on whether or not to authorizecommercial planting of GM crops, following theresults of the current UK farm scale trials.The admixture of imported Bt transgenes intolandrace varieties of Mexican maize alsopresents difficulties. An ethical evaluationis made of the claim that organic growersshould expect protection from adventitioustraces of GM constructs in their products. Towhat extent – on either side of the debate –can any particular group in society set upagricultural standards for itself that mayeffectively restrain others from an otherwisejust business? The assumptions behind notionslike ``purity'' and ``contamination'' areexamined, together with their underlying viewsof nature and human intervention. The 2001UK Agriculture and Environmental BiotechnologyCommission report is relevant to theseissues. While the Government wishes to promotethe UK biotechnology industry and is underpressure from US claims of trade restraint, astrong organic lobby demands purity from GMcontamination. Does this adversarial framingof the issues reflect broader public opinionin the UK public consultation? Inarriving at policy decisions, the role of thevirtue of tolerance is considered inpost-modern and Christian ethical contexts.     

How Preferences for Public Participation are Linked to Perceptions of the Context, Preferences for Outcomes, and Individual Characteristics

Practitioners and stakeholders involved in environmental and risk assessment and decision-making efforts have access to a growing list of policies and guidance for implementing good process. The advice is often general. There is little understanding of how situation specific features are relevant in new circumstances. In a series of ten case studies we investigated how people’s (a) perceptions of the context, (b) preferences for outcomes, and (c) affiliations, experiences and motivations are related to their preferences for process features in a particular situation. The cases are in three policy areas: watershed management, forestry management, and clean-up and public health management of radioactively contaminated sites. We conclude this paper with a discussion of how the results can inform process design. Process design should be based on a diagnostic approach that specifically assesses relevant situational characteristics.     

我国开展政策环评的必要性及其基本框架研究

政策环评对决策科学化和民主化具有重要意义，我国2014年修订的《环境保护法》也为开展政策环评提供了一定法律依据。然而，由于我国政治体制和决策模式与西方国家明显不同，政策环评不能照搬国外模式，必须基于自身国情探索中国模式。为此，本文对国际上比较有代表性的政策环评实践进行了总结，对我国开展政策环评的必要性进行了分析，并探讨了我国开展政策环评需要考虑的关键问题，包括政策环评的目的、对象、重点和程序等。具体而言，对于实施政策环评的目的，可表述为健全决策机制、促进环境公平和凝聚社会共识三个方面；对于评价对象，在广义上可包含目前环境影响评价法尚未覆盖的所有高层次决策，在狭义上可将政府部门制定的行政法规、规章和规范性文件等作为重点；对于评价重点，建议整合"以影响为核心"的战略环评和"以制度为核心"的战略环评两种类型的优点，兼顾影响评价和制度评价；对于评价程序，政策环评应基于完全理性决策模式，与政策过程充分融合，在不同阶段分别发挥不同作用。