Applying legal sunshine to the hidden regulation of biological control

This article identifies a serious legal gap in current United States Department of Agriculture (USDA) policy concerning decisions about the review and release of biological pest control agents. Currently, most of the critical documents and the quantitative evidence underlying USDA decisions and policy related to the petition, review, and release of biological pest control agents (biocontrols) for weeds are inaccessible. Current practices do not provide sufficient information for biologists or an informed public to understand or evaluate policy decisions and environmental outcomes. The USDA needs to comply with federal law by making all relevant documents and data available on the internet. Federal law and policy requires that the USDA release all relevant information, and make it readily accessible to all interested parties. Public disclosure of all relevant documents, along with the scientific evidence related to the review and release of biocontrols, is required by the Administrative Procedure Act, the Freedom of Information Act, the Federal Advisory Committee Act, the National Environmental Policy Act of 1970, and the Plant Protection Act of 2000. Disclosure of this information will impose at most a trivial financial and administrative burden on the USDA Animal and Plant Health Inspection Service, or the Division of Plant Protection and Quarantine. The importance of full information and open debate in the pursuit of both scientific knowledge and sound environmental management far outweighs any administrative burden.     

Application of GMOs in the U.S.: EPA research & regulatory considerations related to soil systems

During the last 20 years recombinant biotechnology has resulted in the development of organisms with unique genetic compositions, some of which are for intentional release to the environment. While concerns have been raised that such organisms may be capable of inducing transient unintended environmental effects, longer-term perturbations to soil processes and non-target species effects have yet to be demonstrated. In parallel with the growth of the commercial biotechnology industry has come a significant growth in regulatory review processes intended to evaluate the risks of these GMO products. Under the Toxic Substances Control Act (TSCA), certain new microbial products that undergo pre-manufacture review are examined for human and environmental risks using data and other information received in accordance with the U.S. Environmental Protection Agency’s (EPA’s) “Points to Consider” guidance document. In the risk assessment process, carried out under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) authorities, EPA evaluates both microbial pesticide products and plants with pesticidal properties to determine if Federal safety standards are met. For all pesticide products, including genetically engineered pesticides, EPA receives testing of product composition and chemical properties, human health effects, environmental effects on non-target pests, and the fate of the pesticide in the environment. The EPA’s Office of Research and Development supports risk assessment research related to such GMO products. This paper focuses on relevant EPA research and regulatory examples related to soil effects considerations for GMOs.     

Regulation of food enzymes

In this review the development of federal policy for the regulation of enzymes is summarized. Defining enzymes as food additives and considerations of the health and safety aspects of employing enzymes in food processing are described. A review of the status of GRAS petitions dealing with enzymes by the governmental review branch is discussed, along with recent developments recommending major changes in the Federal Food, Drug and Cosmetics Act, which is the basic law covering food safety.     

HUMAN DIGNITY IN INTERNATIONAL POLICY DOCUMENTS: A USEFUL CRITERION FOR PUBLIC POLICY?

Current developments in biomedicine are presenting us with difficult ethical decisions and raising complex policy questions about how to regulate these new developments. Particularly vexing for governments have been issues related to human embryo experimentation. Because some of the most promising biomedical developments, such as stem cell research and nuclear somatic transfer, involve such experimentation, several international bodies have drafted documents aimed to provide guidance to governments when developing biomedical science policy. Here I focus on two such documents: the Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being and the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being. I argue that by using human dignity as a criterion to determine the permissibility of particular human embryo research practices, these documents cannot aid in identifying research that would be contrary to human dignity. Thus, they fail to guide public policy on embryo experimentation. Their use of human dignity as a criterion makes their task of offering guidance unfeasible because the concept as used in these documents is too vague and is applied in contradictory ways. I discuss the main goals of these documents and their claims in relation to human embryo research. I then discuss how they have influenced public policy in several countries. Finally, I show that although these Council of Europe treaties attempt to serve as public policy guides in the area of embryo research, they fail to do so.     

Mitigating the effects of insecticides on arthropod biological control at field and landscape scales

Integrated pest management (IPM) programs emphasize the combination of tactics, such as chemical and biological control, to maintain pest populations below economic thresholds. Although combining tactics may provide better long-term sustainable pest suppression than one tactic alone, in many cases, insecticides and natural enemies are incompatible. Insecticides can disrupt natural enemies through lethal and sub-lethal means causing pest resurgence or secondary pest outbreaks. Legislative actions such as the Food Quality Protection Act (US) and the Directive on Sustainable Use of Pesticides (EU) have placed greater restrictions on insecticides used in agriculture, potentially enhancing biological control. Here we focus on the effects of insecticides on biological control, and potential mitigation measures that can operate at different scales. At the farm scale, natural enemies can be conserved through the use of selective insecticides, low doses, special formulations, creation of refugia, special application methods, and targeted applications (temporal or spatial). At the landscape scale, habitat quality and composition affect the magnitude of biological control services, and the degree of mitigation against the effects of pesticides on natural enemies. Current research is teasing apart the relative importance of local and landscape effects of pesticides on natural enemies and the ecosystem services they provide, and the further development of this area will ultimately inform the decisions of policy makers and land managers in terms of how to mitigate pesticide effects through habitat manipulation.     

DRUG DANGERS AND REACTIONS

The protection of the consumer against dangerous, adulterated, and misbranded drugs provided by the Federal Food, Drug, and Cosmetic Act has failed in some instances. A general program of reporting adverse drug reactions has been initiated on a pilot basis. Arrangements are being made to extend this program into larger hospitals. Better and more complete reporting of adverse drug reactions together with tightening of the Food and Drug law regarding new drugs will improve this situation.Recently the president of the National Academy of Sciences appointed a committee at the request of the Secretary of Health, Education, and Welfare to review the policies and procedures used by the Food and Drug Administration in reaching decisions and to present recommendations. This committee has completed its work and has made specific recommendations that would give the Food and Drug Administration authority to require proof of efficacy as well as safety of all new drugs, and would provide it with sufficient resources to meet the responsibilities assigned to it.     

Forest conservation and environmental management in Nepal: a review

This paper provides information on the status of forests and environmental problems related to forestry in Nepal. It aims to integrate the conservation and sustainable management of forests as a part of environmental planning. A critical review of the main environmental problems with prioritization within the forestry sector; thorough review of all forest related documents, strategies, development plans, programs, institutional arrangements, policies mentioned in the Master Plan for Forestry Sector Nepal of 1988, and other relevant documents; identification of major gaps and constraints of forestry policy and plans and current practices of forest conservation and management have been done. The decline in forestry resources in Nepal took place in the past due to lack of appropriate policy to guide the legal, institutional and operational development for the forestry sector. Forestry policy in Nepal, in the past, was shaped by political and economic motives rather than ecological considerations. Policy formulation mechanisms exist in Nepal; however, there is an excessive delay in translating policies into legislation and then into operational rules and administrative orders. There is a need to implement the international obligations by transforming them into regulations in order to make them legally binding. The data to be generated in the coming years in the areas of forestry at both national and international levels suggest that we should revise the research priorities and strategies. Research to add value to the forest resource products has yet been neglected. More attention is required on regular monitoring and evaluation of the projects. A thorough evaluation of the programs and planning for the forestry sector in Nepal is urgently required to update the progress and revise the programs.     

What works in conservation? Using expert assessment of summarised evidence to identify practices that enhance natural pest control in agriculture

This paper documents an exercise to synthesize and assess the best available scientific knowledge on the effectiveness of different farm practices at enhancing natural pest regulation in agriculture. It demonstrates a novel combination of three approaches to evidence synthesis—systematic literature search, collated synopsis and evidence assessment using an expert panel. These approaches follow a logical sequence moving from a large volume of disparate evidence to a simple, easily understandable answer for use in policy or practice. The example of natural pest regulation in agriculture was selected as a case study within two independent science-policy interface projects, one European and one British. A third funder, a private business, supported the final stage to translate the synthesized findings into a useful, simplified output for agronomists. As a whole, the case study showcases how a network of scientific knowledge holders and knowledge users can work together to improve the use of science in policy and practice. The process identified five practices with good evidence of a benefit to natural pest regulation, with the most beneficial being ‘Combine trap and repellent crops in a push–pull system’. It highlights knowledge gaps, or potential research priorities, by showing practices considered important by stakeholders for which there is not enough evidence to make an assessment of effects on natural pest regulation, including ‘Alter the timing of pesticide application.’ Finally, the process identifies several important practices where the volume of evidence of effects on natural pest regulation was too large (>300 experimental studies) to be summarised with the resources available, and for which focused systematic reviews may be the best approach. These very well studied practices include ‘Reduce tillage’ and ‘Plant more than one crop per field’.     

Risk management decisions for pesticides and threatened and endangered species: The role of uncertainty analysis

Despite data gaps and information shortfalls, government agencies in the United States are expected to produce timely and defensible decisions to regulate pesticide use under the Federal Insecticide, Fungicide, and Rodenticide Act and in compliance with the Endangered Species Act. The decision to register a pesticide is predicated on a conclusion that no unreasonable effects will accrue to the environment, including threatened and endangered species. We recognize that the definition of acceptable risk is a policy judgment stemming from legislative language and judicial interpretation. However, a common risk assessment approach with similar technical underpinnings and a high degree of transparency used by all the agencies would be cost effective and more likely to achieve consensus among interested parties. Quantitative probabilistic risk assessment (PRA) methods can be used to develop risk estimates and to describe the level of confidence in these estimates. PRA methods can also differentiate among the contributions of natural stochasticity, measurement variability, and lack of knowledge. Because this approach enhances transparency and increases understanding of the implications of limited data sets and associated assumptions, we encourage the appropriate agencies to implement PRA methods as a means of reaching common ground when assessing risks of pesticides to listed species.     

Natural products in crop protection

The tremendous increase in crop yields associated with the ‘green’ revolution has been possible in part by the discovery and utilization of chemicals for pest control. However, concerns over the potential impact of pesticides on human health and the environment has led to the introduction of new pesticide registration procedures, such as the Food Quality Protection Act in the United States. These new regulations have reduced the number of synthetic pesticides available in agriculture. Therefore, the current paradigm of relying almost exclusively on chemicals for pest control may need to be reconsidered. New pesticides, including natural product-based pesticides are being discovered and developed to replace the compounds lost due to the new registration requirements. This review covers the historical use of natural products in agricultural practices, the impact of natural products on the development of new pesticides, and the future prospects for natural products-based pest management.     

The Use Of Methods For Injury Determination And Quantification From Natural Resource Damage Assessment In Ecological Risk Assessment

Several Federal statutes provide the government the authority to recover natural resource damages including the Clean Water Act Amendments (1977), the Outer Continental Shelf Act Amendments (1978), the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, and the Oil Pollution Act of 1990 (OPA 90). CERCLA and OPA 90 are the principle Federal statutes which authorize trustees to assess damages for trust resources which are lost, injured, or destroyed as a result of the discharge of oil or the release of hazardous substances. The Department of the Interior was charged with developing natural resource damage assessment (NRDA) regulations and procedures from CERCLA and the Department of Commerce, National Oceanic and Atmospheric Administration (NOAA) was charged with developing regulations for OPA 90. NRDA is a process for making the public “whole” for direct injury to natural resources and/or the services of natural resources. The primary objectives of the NRDA process are to identify and quantify natural resource injury, determine the damages resulting from the injury, and develop and implement appropriate restoration actions. The goal is to be accomplished by implementing a plan for the restoration, rehabilitation, replacement, or acquisition of equivalent natural resources. NRDA is an after-the-fact process; however, the OPA 90 NRDA rules describe a pre-spill planning process. The models and formulae can be used in this pre-spill planning process to estimate damages (both ecological and economic). Some of those tools, in particular NRDAMCME, have uses in ranking risk from spills of petroleum products and hazardous substances. This information can be used to protect ecological resources and lower NRDA costs through pre spill planning and management of resources during a spill.     

The Psychology Underlying the Art Activity Program

The author investigates the condition of a public school's arts education program under the No Child Left Behind (NCLB) Act and obtains teachers' perspectives on their experiences under the federal policy. The author used qualitative and quantitative approaches to conduct a case study of an Ohio public school district. The data collected revealed changes in the arts education curriculum, particularly in music. Teacher interviews provided the context in which the changes occurred and a more accurate representation of the decrease in arts learning opportunities and the challenges that exist for arts education funding under NCLB. The information illustrated how administrative decisions made to improve test scores and accommodate policies mandated by NCLB threatened arts education.     

Bt: mode of action and use

The insecticidal toxins from Bacillus thuringiensis (Bt) represent a class of biopesticides that are attractive alternatives to broad-spectrum "hard" chemistries. The U.S. Food Quality Protection Act and the European Economic Council directives aimed at reducing the use of carbamate and organophosphate insecticides were expected to increase the use of narrowly targeted, "soft" compounds like Bt. Here we summarize the unique mode of action of Bt, which contributes to pest selectivity. We also review the patterns of Bt use in general agriculture and in specific niche markets. Despite continued predictions of dramatic growth for biopesticides due to US Food Quality Protection Act-induced cancellations of older insecticides, Bt use has remained relatively constant, even in niche markets where Bt has traditionally been relatively high.     

U.S. EPA Reference Dose/Reference Concentration Methodology: Update on a Review of the Process

The U.S. Environmental Protection Agency (USEPA) has been reviewing several approaches to testing and risk assessment related to implementation of the Food Quality Protection Act (FQPA) and the Amendments to the Safe Drinking Water Act (SDWA), both signed into law in 1996. Based on recommendations from a review of issues related to children's health protection under these laws, the USEPA established the RfD Technical Panel to evaluate in depth the current reference dose (RfD) and reference concentration (RfC) process in general, and in particular with respect to how well children and other potentially sensitive subpopulations are protected. The RfD Technical Panel also was asked to consider scientific issues that have become of greater concern in RfD and RfC derivation (e.g., neurotoxicity, immunotoxicity), and to raise issues that should be explored or developed further for application in the RfD/RfC process. This paper provides the current status of the activities of the RfD Technical Panel. The Technical Panel has recommended that acute, short- term, and intermediate reference values should be set for chemicals, where possible, and that these values should be incorporated into the USEPA's Integrated Risk Information System (IRIS) Database. A review of current testing procedures is underway, including the endpoints assessed, life stages covered by exposure and outcome evaluation, and information that can be derived from current protocols on various durations of exposure. Data gaps identified for risk assessment include the types of pharmacokinetic data that should be collected, especially for developmental toxicity studies, the impact of aging on toxic responses occurring after early exposure as well as concomitant with exposure in old age, and information available on latency to response. The implications of the RfD Technical Panel's recommendations for various uncertainty factors are also being explored.     

Legalization of Eco-balances in Germany

The development and use of, as well as scientific discussions on, eco-balances and in particular life cycle assessment has largely occurred without involving experts on environmental law. However, in the light of recent proposals to ‘legalize’ eco-balances, i.e. formally introducing them into environmental law, the legal implications of eco-balancing must be addressed in the future. The formal introduction, especially of LCA, cannot be decided independent of the general economic and environmental policy implications of material flow management, and it raises major questions of policy and constitutional law. An important question of principle is whether eco-balances should be prescribed or only a legal framework set forth for voluntary use. In view of the unfinished methodological development of LCA, any formal introduction raises the constitutional problem of conformity with the requirements of legal certainty. References to the ‘principles of good eco-balancing’ are problematic, and an introduction on an experimental basis would have to be confined to cases where the legal consequences of grossly divergent interpretations of this term are tolerable to affected firms. Where eco-balances are prescribed as a method of preparing governmental or administrative decisions, one must determine whether and to what extent they are binding on the decision-maker, and develop proper mechanisms of participation, transparency and critical review.     

Harmonization of regulations for invertebrate biocontrol agents in Europe: progress,problems and solutions

The use of non‐native invertebrate biological control agents (IBCAs) in Europe is not covered by a Directive equivalent to that which regulates biocontrol with microorganisms or the genetic modification of crop plants. Regulation is at the discretion of individual member states and largely derived from national legislation on pesticides, plant health or environmental protection. There is no EU country with regulation of IBCAs that requires information on the microbial symbiont content of candidate species, and in the absence of horizontal transfer under natural conditions, this policy is unlikely to change. Although there have been few reported negative effects linked to the import and release of IBCAs, a number of countries have introduced or revised their regulatory frameworks in recent years. This article reviews major developments in the regulation and environmental risk assessment (ERA) of IBCAs in Europe over the last 10 years including: the fragmented pattern of regulation between countries, variation in information requirements for release licences, format and methods of ERA for different taxonomic groups of IBCAs, use and updating of the European Plant Protection Organisation Positive List, sources of expert advice on ERA data, communication between IBCA regulators, and options for the provision of international leadership to coordinate regulatory and ERA‐related issues with IBCA‐based biocontrol in Europe.     

First Occurrence of <Emphasis Type="Italic">Sternochetus mangiferae</Emphasis> (Fabricius) (Coleoptera: Curculionidae) in Brazil

Specimens of the mango stone weevil Sternochetus mangiferae (Fabricius) (Coleoptera: Curculionidae) were found in fruits of mango from a tree in the residential area of the Rio de Janeiro, RJ. This is the first report of the S. mangiferae in Brazil, currently regulated as an absent quarantine pest in the country. A taxonomist specialized in Curculionidae confirmed the identification based on morphological diagnostics characteristics. This detection is a relevant finding, because Brazil is a major producer and exporter of mango and the main areas of mango for exportation are located very far from this detection point. This pest damages seed and embryo of mango fruits and it causes reduction of fruit size and its premature dropping. The detection was notified to the Plant Health Department, division of the Brazilian Ministry of Agriculture, Livestock and Food Supply (MAPA), which is the National Plant Protection Organization of Brazil.     

Euserica modesta Fairmaire (Coleoptera: Scarabaeidae): a new record for a chafer insect pest attacking citrus orchards in Egypt

Many pests and diseases are widely spread and attack several plants and agricultural products. During September 2008, a new chafer insect pest, Euserica modesta Fairmaire (Coleoptera: Scarabaeidae) was recorded for the first time in the south Sinai region, north of Egypt. This insect was shown to attack and destroy flowers and leaves of citrus orchards. It was identified by the Department of Classification, Plant Protection Research Institute, Agriculture Research Center, Giza, Egypt. In the present study, preliminary investigations offered some information about infestation symptoms. Sites of damage in the host plant and suggested control of the pest E. modesta were described.     

红火蚁入侵云南10年的发生状况与防控策略探析

重大危险性入侵害虫红火蚁Solenopsis invicta Buren在云南已发生10年了,本文基于2013年12月至2022年6月云南省植保植检站统计报表统计数据,分析了红火蚁在云南的分布情况、发生现状,总结了防控成效及存在的主要问题,并对解决这些问题提出了一些建议,以期对云南省红火蚁的防控提供参考。