Federal Insecticide, Fungicide, And Rodenticide Act Research Articles

Challenges with the current methodology for conducting Endangered Species Act risk assessments for pesticides in the United States.

The US Environmental Protection Agency (USEPA or the Agency) is responsible for administering the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency is also required to assess the potential risks of pesticides undergoing registration or re-registration to threatened and endangered (i.e., listed) species to ensure compliance with the Endangered Species Act. To assess potential risks to listed species, a screening-level risk assessment in the form of a biological evaluation (BE) is undertaken by the Agency for each pesticide. Given the large number of registration actions handled by the USEPA annually, efficient tools for conducting BEs are desirable. However, the "Revised Method" that is the basis for the USEPA's BE process has been ineffective at filtering out listed species and critical habitats that are at de minimis risk to pesticides. In the USEPA's BEs, the Magnitude of Effect Tool (MAGtool) has been used to determine potential risks to listed species that potentially co-occur with pesticide footprints. The MAGtool is a highly prescriptive, high-throughput compilation of existing FIFRA screening-level models with a geospatial interface. The tool has been a significant contributor to risk inflation and ultimately process inefficiency. The ineffectiveness of the tool stems from compounding conservatism, unrealistic and unreasonable assumptions regarding usage, limited application of species-specific data, lack of consideration of multiple lines of evidence, and inability to integrate higher-tier data. Here, we briefly describe the MAGtool and the critical deficiencies that impair its effectiveness, thus undermining its intention. Case studies are presented to highlight the deficiencies and solutions are recommended for improving listed species assessments in the future. Integr Environ Assess Manag 2023;19:817-829. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Development of a US national-scale, mixed-source, pesticide, rural well database for use in drinking water risk assessment: an atrazine case study.

For pesticide registrations in the USA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as implemented by the United States Environmental Protection Agency, drinking water risk assessments for groundwater sources are based on standard scenario modeling concentration estimates. The conceptual model for the drinking water protection goals is defined in terms of (1) a rural well in or near a relatively high pesticide use area, a shallow well (4-10m); (2) long-term, single-station weather data; (3) soils characterized as highly leachable; (4) upper-end or surrogate, worst-case environmental fate parameters; and (5) maximum, annual use rates repeated every year. To date, monitoring data have not been quantitatively incorporated into FIFRA drinking water risk assessment; even though considerable, US national-scale temporal and spatial data for some chemistries exists. Investigations into drinking water monitoring data development have historically focused on single-source efforts that may not represent wide geographies and/or time periods, whereas Safe Drinking Water Act groundwater monitoring data are focused on a community-level scale rather than an individual, shallow, rural well. In the current case study, US national-scale, rural well data for the herbicide atrazine was collected, quality controlled, and combined into a single database from mixed sources (termed the atrazine rural well database) to (1) characterize differences between exposure estimates from standard EPA modeling approaches for specific characterization, (2) evaluate monitoring data toward direct use in US drinking water risk assessments to compliment or supersede standard modeling approaches to define risk, and (3) evaluate monitoring trends a function of time relative to label changes implemented as part of the registration review process. Of the 75,665 drinking water samples collected from groundwater, atrazine was only detected in 3185, a 4% detection rate.

A Retrospective Study on Agrocultural Poisoning: Causes and Effects

A rise in the usage of pesticides in agriculture has coincided with an increase in the number of people who have been poisoned by them. Herbicides greater part are incessant agrochemical poisons, trailed by organophosphates. Numerous horticultural toxins, such as ethyl parathion and defoliant, have been banned in recent years. To discourage illicit use, they are combined with a coloring agent such as indigo carmine. Additionally, parquet has a "stanching" ingredient. Organochlorines work through a completely different process. Whereas Organophosphates are anti-cholinesterase, while organochlorines are anti-cholinesterase. Meddling with the transmission of driving forces through nerve cells. Organochlorines give out a kerosene-like odor when people die. The presence of organochloride in the gut contents or offal is used to make the diagnosis. Organochlorines are resistant to putrefaction and can be identified long after a person has died. Suicidal, accidental, and homicidal poisonings have all been linked to paraquat. This poisoning is moderately caustic, and ulcers around the lips and mouth is frequent. The severe alterations in the lungs, especially after the sufferer has lived a few days, are the hallmark of paraquat poisoning. Algicides, aphicides, herbicide safeners, fertilisers, and other agrochemicals are less often seen. Most governments have enacted regulations to avoid unintentional poisonings from these substances. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was passed by the US government in 1962, while the Indian sovereignty proceeded The Insecticides Act in 1968. These laws, in addition via other things compel pesticide producers to include signal phrases on their labels to alert the public to their toxicity and associated dangers.

How Protective to the Environment is the Pesticide Risk Assessment and Registration Process in the United States?

The media, public, and other stakeholders are generally unaware of the degree of protection provided to the environment by the current pesticide registration process in the United States. Each pesticide product must meet extensive fate and toxicological data requirements (typically 100+ studies) to be considered by the U.S. Environmental Protection Agency (EPA). The EPA uses that information to conduct ecological, human health, and benefits assessments and make decisions on whether to register pesticides and, if so, under what conditions. The assessments rely on conservative assumptions, models, and inputs to consistently err on the side of caution throughout the pesticide registration process. The rigorous compliance requirements specified in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Endangered Species Act (ESA) are designed to preclude unacceptable adverse effects. However, this reality seldom, if ever, makes headlines. Pesticides are not causing the dire widespread apocalyptic effects often portrayed by some media outlets. Rather, pesticides have been doing what they were intentionally designed to do, controlling pests and increasing yields, within the stringent limitations of registered labels. The continually evolving pesticide registration process was originally predicated on the unintended adverse effects neither anticipated nor considered over 50 years ago, due to insufficient regulation and oversight at the time. However, the contemporary regulatory paradigm in the U.S. is data rich and analysis intensive by design, and perhaps understandably, biased towards ensuring environmental protection when registering pesticides. https://doi.org/10.21423/jrs-v09i2moore

Translating Observational Research into Regulatory Science: The Role of U.S. EPA's Office of Pesticide Programs in Evaluating Epidemiologic Evidence

The U.S. Environmental Protection Agency’s Office of Pesticide Programs (OPP) is a licensing program that regulates pesticides in the U.S under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). As part of this program, OPP has a regulatory mandate to evaluate a substantial body of health effect and exposure data in order to assess the effects of pesticides on human health. Through this evaluation, OPP plays a critical role in translating observational research into regulatory science and aims to ensure that pesticide risk assessments incorporate epidemiologic evidence on the potential adverse effects on people that may result from pesticide exposure through dietary, environmental, and occupational exposure pathways. The thematic poster will provide background on OPP’s regulatory requirements and then describe the systematic review methodology used to evaluate epidemiologic evidence based on a scientifically robust and transparent approach. This description will emphasize key regulatory considerations and outline elements of OPP’s 2016 framework for incorporating epidemiological data into risk assessments for pesticides. The 2016 framework may be of interest to a range of stakeholders in the scientific community and characterizes OPP’s “fit-for-purpose” approach to systematic review. OPP uses this approach to define to the scope and complexity of reviews and integrate epidemiologic findings into OPP’s overall risk assessment process.

Scope and Application of the FIFRA Treated Articles Exemption

This paper discusses the U.S. Environmental Agency’s potential improper expansion of its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the federal pesticide statute, to regulate not only the registration, labeling, and use of wood preservatives, but also treated wood products. EPA’s oversight of wood preservatives under FIFRA is extensive. In recent years, despite EPA’s own Treated Articles Exemption, 40 C.F.R. § 152.25(a), EPA has moved toward utilizing wood preservative labeling in a way that could impose restrictions on the end use of treated wood. Wood preservative registrant and user groups should be concerned and vigilant about this trend toward regulation of treated wood. At the same time, they should continue to interact with EPA in a constructive manner, in part to ensure that EPA respects its own regulatory boundary between wood preservatives, such as creosote, and treated wood, such as creosote-treated railroad crossties, which are a key component of the nation’s transportation critical infrastructure.

The Case for Disclosure of Biologics Manufacturing Information.

Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers. As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients. This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.

The effects of continuous diazinon exposure on growth and reproduction in Japanese medaka using a modified Medaka Extended One Generation Reproduction Test (MEOGRT)

The Medaka Extended One Generation Reproduction Test (MEOGRT) is a Tier 2 test within U.S. Environmental Protection Agency's (USEPA) Endocrine Disruptor Screening Program (EDSP), designed to characterize the potential adverse effects to fish of exposure to chemical that can cause disruption of the endocrine system. The MEOGRT focuses primarily on adverse effects to reproduction while collecting information regarding effects on growth, survival, and endocrine-related endpoints. However, the risk assessment process for fish, as mandated by legislation such as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or the Toxic Substances Control Act (TSCA), could benefit from a more detailed assessment of effects on growth. Typically, fish growth data in support of risk assessment are obtained from full life-cycle tests or early life stage tests using the fathead minnow. As an alternative to these tests, a modified MEOGRT was conducted to assess the effects of diazinon on the various parameters measured in the MEOGRT. Diazinon is an organophosphate insecticide that is detected in the environment, and whose efficacy is a result of inhibition of the acetylcholine esterase enzyme at neuromuscular junctions and synapses of the nervous system. Diazinon (2.9, 5.2, 10.3, 19.8, and 40.2 μg/L) was tested with the MEOGRT protocol, and the lowest observable effect concentrations of 2.9 μg/L for fecundity and 5.2 μg/L for growth were determined. Additional growth measurements were added to the MEOGRT protocol to more robustly define growth rates and to determine the impact size has on reproductive performance. Fish size starting at the first measurement day (i.e. 21 days post-fertilization), and continuing through the duration of the test was reduced with exposure to 5.2 μg/L and higher, and asymptotic size predicted from growth modeling was reduced at 10.3 μg/L and higher. By simply adding non-destructive growth measurements at two additional time points, the MEOGRT provided enough data for the parameterization of growth models, which could be used to characterize the reproductive implications of growth impairment.

Establishing Laboratory Analysis Procedure for EPA FIFRA Enforcement Samples to Meet the ISO/IEC 17025:2005 Requirements using Flexible Scope Approach

An ISO/IEC 17025:2005 accredited laboratory procedure that quantifies analytes and validates an analytical method used simultaneously was established for analyzing pesticide misuse samples. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the U.S. Environmental Protection Agency (EPA) grants the authority over regulating pesticide use to each state. Samples for pesticide misuse cases such as drift complaints are analyzed by state laboratories (state FIFRA labs). State FIFRA labs receive samples that require quick turnaround with a variety of unique matrix/analyte combinations. The majority of the samples are analyzed by non-standard methods that are developed by the laboratory. It is impractical to pre-validate such non-standard methods. Yet, the forensic nature of pesticide misuse investigation samples demands legally defensible analytical data. The author's laboratory developed an expedited validation procedure that is conducted simultaneously with analyte quantitation by using the standard addition technique. The procedure received ISO/IEC 17025:2005 accreditation from the American Association for Laboratory Accreditation under their Flexible Scope Policy. The developed validation protocol and associated procedural changes made to the daily operations are supported by several laboratory documents that are unique to the Flexible Scope option.https://doi.org/10.21423/jrs-v05n02p010 (DOI assigned 3/11/2019)

Implementing toxicity testing in the 21st century: challenges and opportunities

The publication of the US National Academy of Sciences report Toxicity Testing in the Twenty-First Century: A Vision and a Strategy (TT21C) has led to the development of new scientific techniques to modernise regulatory toxicity testing. From 2009 to 2010, a series of five international symposia were held to examine challenges, opportunities and policy issues associated with TT21C. Seven key themes emerged based on these meetings; that the TT21C vision and strategy: 1) is not self-implementing; 2) demands new toxicology techniques; 3) has a number of scientific knowledge gaps that need to be filled; 4) requires evaluation of the new tests to determine relevance, reliability, validity and regulatory acceptance by government agencies; 5) can be implemented under TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as currently written; 6) requires multi-stakeholder input and commitment; 7) should harmonise acceptance of test data and methods on an international level.

Stephen J. Klaine.

Steve spent more than 30 yr conducting environmental research and educating graduate students. He has graduated 40 doctoral and 45 master's students from his laboratory. He usually had more students at Society of Environmental Toxicology and Chemistry (SETAC) meetings than any other professor, which meant more presentations than from any other university! Steve was all about his students and their research. Every SETAC meeting had an evening for the Klaine tribe—his current and past graduate students and a host of colleagues from around the globe. As a doctoral student with Herb Ward at Rice University he had the prestigious duty of being the first official photographer for the first SETAC meeting held in Washington, D.C. He served on SETAC's Board of Directors and was an editor for Environmental Toxicology and Chemistry since 1995. He was also on the editorial board of the journal, Nanotoxicology. The review paper he led on nanomaterials in the environment has the distinction of being the most highly cited paper of Environmental Toxicology and Chemistry in the journal's 35 yr of publication! From 1995 to 2000 he was the only US participant on a multinational International Atomic Energy Agency Cooperative Research Program on Pesticides in Coastal Tropical Ecosystems. He served on several US Environmental Protection Agency (USEPA) science advisory panels and workshops dealing with pesticide and metal fate, effects, and risk assessment, and also chaired the USEPA Science Advisory Panel for The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). He was a Sigma Xi National Lecturer, won the Clemson University Sigma Xi Researcher of the Year Award, and the Clemson Alumni Award for Outstanding Research. He was the SETAC Menzie Environmental Education Award winner for 2013 and an inaugural member of the SETAC Fellows Program. Steve's research program was impressive, with over $10 million in extramural funding and over 120 peer-reviewed publications. Steve was also committed to international student outreach—teaching in Cuba, Jamaica, Canada, Portugal, Vietnam, Africa, and Australia. His efforts at capacity building over the last 15 yr in Vietnam resulted in the first collaborative master's program in environmental toxicology between Hanoi University of Science and Clemson University. I heard Steve's voice long before I met him. It was at the SETAC meeting in Seattle in the early 1990s, and as always, he was surrounded by lots of people, hands in the air, a huge smile, and a booming laugh! People have always loved Steve. I interviewed at Clemson and knew right away we would be friends for life. Our friendship was based on a solid foundation of fondness for liquid yeast by-products, good food, intense sarcasm, laughter, and intellectual debate. For most of the early years, Steve and I agreed on very little when it came to environmental toxicology and how our research interests meshed, but it was never personal. Most of our debates ended in laughter, followed by sampling of cold yeast by-products, which drove conversations to more important issues of family, kids, politics, religion, and more conversation about kids. Steve's love and pride for his son Christopher and daughter Jennifer could not be measured. The same can be said of the love and pride he had for his many graduate students, which are too numerous to address in this venue. Steve was devoted to his wife Cindy, and together they traveled to the far reaches of our planet. Steve was a “Leo the Lion,” and his presence and voice at Clemson University seemed to quell the pervasive ebb and flow of academia in turmoil. I readily admit that Steve was the backbone of environmental toxicology at Clemson University, and, as a graduate program we are unsure where to go without his guidance. On a personal note, I find the silence following the loss of Steve, deafening. Charles Rice Clemson University Clemson, South Carolina, USA G. Allen Burton, Jr. Environmental Toxicology and Chemistry Ann Arbor, MI, USA Richard J. Wenning Integrated Environmental Assessment and Management San Francisco, California, USA Herb Ward Rice University Houston, Texas, USA Teresa F. Fernandes Heriot-Watt University Edinburgh, Scotland, UK Jamie Lead University of South Carolina Columbia, South Carolina, USA Aaron Roberts University of North Texas Denton, Texas, USA Eric van Genderen International Zinc Association Durham, North Carolina, USA

The Ground View of Navigating FIFRA and the ESA: One Pesticide Registrant's Perspective

The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), enacted in 1947 and amended in 1972, 1978, and 1988, established federal regulation of pesticides in order to protect human and environmental health. FIFRA has been under the jurisdiction of the U.S. Environmental Protection Agency (EPA) since the EPA’s inception in 1970. Although FIFRA requires EPA to consider the benefits of a pesticide’s use, EPA must ensure that the pesticide is used without posing unreasonable adverse effects to human health or the environment. Furthermore, the Endangered Species Act (ESA), enacted in 1973, requires federal agencies to protect species vulnerable to extinction without consideration of costs. The amendments to FIFRA in 1972, 1978, 1988, and 1996 mandated the EPA review and reevaluate the eligibility of older pesticide products for reregistration under the updated FIFRA standard, while also complying with the new environmental laws of the 1970s. Today EPA’s goal is to review existing pesticide product registrations at least every 15 years under “Registration Review.” To meet their responsibilities under the ESA, EPA is initiating consultations with the U.S. Fish and Wildlife Service (USFWS) during the Registration Review process. The first pesticide active ingredients to advance to consultations under Registration Review are those in gas cartridge products. The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) holds two gas cartridge product registrations. As a federal agency, APHIS also must comply with the ESA and consults with the USFWS on wildlife damage management activities, including tools such as pesticide products. This discussion presents APHIS’ unique ground view as a federal agency navigating the EPA’s ESA consultations during the Registration Review process, and describes the mitigation measures and their impacts on APHIS Wildlife Services’ activities.

In Response: A Government perspective.

In Response: A Government perspective.

Federal environmental and occupational toxicology regulations and reporting requirements: a practical approach to what the medical toxicologist needs to know, part 2.

Toxicologists are often called upon to assist in environmental, industrial, occupational and public health assessments. Accordingly, medical toxicologists may find it prudent to be aware of applicable federal toxicological regulations and reporting requirements and of the roles of relevant federal agencies. These regulations are numerous, complex, and have evolved and expanded over time, making it difficult for toxicologists to sustain a current knowledge base. This article reviews the pertinent federal toxicological reporting requirements with regards to the Toxic Substances Control Act (TSCA), the Atomic Energy Act (AEA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Resource Conservation and Recovery Act (RCRA), the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Emergency Planning and Community Right to Know Act (EPCRA), the Occupational Safety and Health Act, the Department of Transportation, and information about the National Response Center. We reference internet-based government resources and offer direct links to applicable websites in an attempt to offer rapid and current sources of practical information. The format of the article is a series of hypothetical scenarios followed by commentary. Discussions of the Safe Drinking Water Act and the Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act are beyond the scope of this paper. For those desiring a more in depth discussion of the relevant federal environmental laws and statutes, and applicable case law, the reader is directed to resources such as the Environmental Law Handbook, the websites of individual laws found at www.epa.gov and the decisions of individual courts of appeal. It is our hope that this article provides not only useful practical information for the practicing toxicologist, but also serves as a key reference for Medical Toxicology core content on environmental laws and regulations.

Federal Environmental and Occupational Toxicology Regulations and Reporting Requirements: A Practical Approach to What the Medical Toxicologist Needs to Know, Part 1

Toxicologists are often called upon to assist in environmental, industrial, occupational and public health assessments. Accordingly, medical toxicologists may find it prudent to be aware of applicable federal toxicological regulations and reporting requirements and of the roles of relevant federal agencies. These regulations are numerous, complex, and have evolved and expanded over time, making it difficult for toxicologists to sustain a current knowledge base. This article reviews the pertinent federal toxicological reporting requirements with regard to the Toxic Substances Control Act (TSCA), the Atomic Energy Act (AEA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Resource Conservation and Recovery Act (RCRA), the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Emergency Planning and Community Right to Know Act (EPCRA), the Occupational Safety and Health Act, the Department of Transportation, and information about the National Response Center. We reference internet-based government resources and offer direct links to applicable websites in an attempt to offer rapid and current sources of practical information. The format of the article is a series of hypothetical scenarios followed by commentary. Discussions of the Safe Drinking Water Act, the Food, Drug, and Cosmetic Act, and the Dietary Supplement Health and Education Act are beyond the scope of this paper. For those desiring a more in-depth discussion of the relevant federal environmental laws and statutes and applicable case law, the reader is directed to resources such as the Environmental Law Handbook, the websites of individual laws found at www.epa.gov and the decisions of individual courts of appeal. It is our hope that this article provides not only useful practical information for the practicing toxicologist but also serves as a key reference for medical toxicology core content on environmental laws and regulations.

The relative sensitivity of macrophyte and algal species to herbicides and fungicides: An analysis using species sensitivity distributions

Lemna spp. are the standard test species representing aquatic macrophytes in the current risk assessment schemes for herbicides and plant growth regulators in the European Union and North America. At a Society of Environmental Toxicology and Chemistry (SETAC) 2008 workshop on Aquatic Macrophyte Risk Assessment for Pesticides (AMRAP), a Species Sensitivity Distribution (SSD) working group was formed to address uncertainties about the sensitivity of Lemna spp. relative to other aquatic macrophyte species. For 11 herbicides and 3 fungicides for which relevant and reliable data were found for at least 6 macrophyte species, SSDs were fitted using lognormal regression. The positions of L. gibba (the most commonly tested Lemna species) and Myriophyllum spicatum (for which standardized test methods are under development) in each SSD were determined where data were available. The sensitivity of standard algal test species required for pesticide registration in the United States under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) relative to the macrophytes in each SSD was also examined (algae were not included in the SSD). L. gibba was among the most sensitive macrophyte species for approximately 50% of the chemicals examined. M. spicatum was among the most sensitive macrophytes for approximately 25% of the chemicals. In most cases, the lowest FIFRA algal species endpoint was lower than the most sensitive macrophyte endpoint. Although no single species consistently represented the most sensitive aquatic plant species, for 12 of 14 chemicals L. gibba and the FIFRA algae included an endpoint near or below the 5th percentile of the macrophyte SSD. For the other compounds, M. spicatum was the most sensitive species of all aquatic plants considered.

Embracing Uncertainty,Complexity, and Change: An Eco-Pragmatic Reinvention of a First-Generation Environmental Law

Recent scientific reports demonstrate that despite more than thirty years of environmental regulation, we are experiencing unprecedented declines in bird and wildlife species, as well as ecosystem services. Pesticides are at least in part to blame for these profound declines. U.S. pesticide law has failed to carryout its mission. Moreover, a number of lawsuits have been filed recently asserting that the registration of certain pesticides is in violation of the federal endangered species act. One of the great ironies of environmental law is that the ecological consequences of pesticide use, such as the devastating impacts DDT had on predatory bird populations, which fueled the environmental movement of the late 1960's and early 1970's, largely have been ignored for the past 30 years. Only very recently has there been renewed interest in the ecological (as opposed to human health) risks posed by pesticides. Moreover, the explosion of pesticidal genetically modified organisms (GMOs) in agriculture has raised concerns regarding the novel risks to biodiversity posed by these new pesticides. Surprisingly, however, the primary federal statute governing pesticides, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), has not changed significantly with regard to ecological matters since 1972 and remains primarily a consumer protection statute not well suited for ecological protection. Moreover, the manner in which the Environmental Protection Agency (EPA) has implemented FIFRA has not kept pace with developments in our understanding of the uncertainty, complexity, and changing nature of ecological systems. This Article breaks new ground by being the first to use the new legal discipline of to analyze, and then reinvent, U.S. pesticide law to better protect ecological resources. For years, environmental legal scholars have sought a middle ground between absolutist risk-based approaches to environmental regulation and cost/benefit analysis approaches. In the past several years, scholars have begun exploring the emerging field of eco-pragmatism - a dramatic new framework for environmental decision-making developed by Professor Daniel Farber - as a way to achieve a workable middle ground. Although a number of prominent legal scholars have analyzed eco-pragmatism in a general sense, none have attempted to apply an eco-pragmatic framework to any environmental pollution control law. This Article is the first to do so. This Article builds on Farber's work and the works of a number of other prominent legal scholars by first bolstering eco-pragmatism through consciously incorporating into it principles of ecological science, and then applying the strengthened eco-pragmatism to a long overlooked area - pesticide law. As the first attempt to actually apply eco-pragmatism to a field of environmental pollution control law, this Article represents an important step in the development of this area of legal theory. By analyzing current pesticide law as well as EPA's implementation of such law through an eco-pragmatic lens, this Article identifies areas of the law that are in need of revision and proposes revisions based on eco-pragmatic principles, which if implemented would greatly enhance our ability to protect critical ecological resources.

Putting Patient Safety First: The Sterile Processing Department and Healthcare Technology Management

<i>Putting Patient Safety First:</i> The Sterile Processing Department and Healthcare Technology Management

Use of butterflies as nontarget insect test species and the acute toxicity and hazard of mosquito control insecticides

Honeybees are the standard insect test species used for toxicity testing of pesticides on nontarget insects for the U.S. Environmental Protection Agency (U.S. EPA) under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). Butterflies are another important insect order and a valued ecological resource in pollination. The current study conducted acute toxicity tests with naled, permethrin, and dichlorvos on fifth larval instar (caterpillars) and adults of different native Florida, USA, butterfly species to determine median lethal doses (24-h LD50), because limited acute toxicity data are available with this major insect group. Thorax- and wing-only applications of each insecticide were conducted. Based on LD50s, thorax and wing application exposures were acutely toxic to both caterpillars and adults. Permethrin was the most acutely toxic insecticide after thorax exposure to fifth instars and adult butterflies. However, no generalization on acute toxicity (sensitivity) of the insecticides could be concluded based on exposures to fifth instars versus adult butterflies or on thorax versus wing exposures of adult butterflies. A comparison of LD50s of the butterflies from this study (caterpillars and adults) with honeybee LD50s for the adult mosquito insecticides on a µg/organism or µg/g basis indicates that several butterfly species are more sensitive to these insecticides than are honeybees. A comparison of species sensitivity distributions for all three insecticides shows that permethrin had the lowest 10th percentile. Using a hazard quotient approach indicates that both permethrin and naled applications in the field may present potential acute hazards to butterflies, whereas no acute hazard of dichlorvos is apparent in butterflies. Butterflies should be considered as potential test organisms when nontarget insect testing of pesticides is suggested under FIFRA.

U.S. EPA Regulation of Plant-Incorporated Protectants: Assessment of Impacts of Gene Flow from Pest-Resistant Plants

The U.S. Environmental Protection Agency licenses pesticide-expressing plants under the authority of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Transgenes and their pesticidal products represent pesticides under FIFRA and are referred to as plant-incorporated protectants (PIPs). When sexually compatible wild relatives (SCWR) are sympatric with PIP crops, there is a need to assess the potential for adverse effects to man and the environment resulting from transgene introgression in accord with FIFRA requirements. Genetic compatibility, introgression, weediness of SCWR × PIP hybrids, seed dispersal, and dormancy, among other parameters, as well as effects on other species (herbivores and beneficial insects), all need to be considered as part of the risk assessment for experimental use under Section 5 or registration under Section 3 of FIFRA. EPA is currently developing data requirements and guidance toward addressing potential gene flow impacts from PIPs.