Emerging Public Health Law and Policy Issues Concerning State Medical Cannabis Programs.

Thirty-four states, the District of Columbia, and Puerto Rico have legalized medical cannabis. While no two state medical cannabis programs are alike, public health concerns related to advertising, packaging and labeling, pesticide use, scientific research, and the role of medical cannabis in the opioid crisis are emerging across the country. This article examines these issues, the policy approaches states are adopting to protect patients and the public, and an assessment of the underlying federal legal landscape.

The USA lags behind other agricultural nations in banning harmful pesticides.

BACKGROUND: The United States of America (USA), European Union (EU), Brazil and China are four of the largest agricultural producers and users of agricultural pesticides in the world. Comparing the inclination and ability of different regulatory agencies to ban or eliminate pesticides that have the most potential for harm to humans and the environment can provide a glimpse into the effectiveness of each nation's pesticide regulatory laws and oversight. METHODS: The approval status of more than 500 agricultural pesticides was identified in the USA, EU, Brazil and China and compared between nations. The amount of pesticides that were used in the USA and banned in these other nations was compiled and linear regression was used to identify trends in use. RESULTS: There are 72, 17, and 11 pesticides approved for outdoor agricultural applications in the USA that are banned or in the process of complete phase out in the EU, Brazil, and China, respectively. Of the pesticides used in USA agriculture in 2016, 322 million pounds were of pesticides banned in the EU, 26 million pounds were of pesticides banned in Brazil and 40 million pounds were of pesticides banned in China. Pesticides banned in the EU account for more than a quarter of all agricultural pesticide use in the USA. The majority of pesticides banned in at least two of these three nations have not appreciably decreased in the USA over the last 25 years and almost all have stayed constant or increased over the last 10 years. CONCLUSIONS: Many pesticides still widely used in the USA, at the level of tens to hundreds of millions of pounds annually, have been banned or are being phased out in the EU, China and Brazil. Of the pesticides banned in at least two of these nations, many have been implicated in acute pesticide poisonings in the USA and some are further restricted by individual states. The United States Environmental Protection Agency (US EPA) has all but abandoned its use of non-voluntary cancellations in recent years, making pesticide cancellation in the USA largely an exercise that requires consent by the regulated industry.

Legal measures to prevent and manage soil contamination and to increase food safety for consumer health: The case of Spain.

This article contains a brief overview of the European and Spanish environmental law framework for the prevention of soil contamination, for the management of contaminated soils and for consumers health protection in relation to agricultural crops. Some important aspects of the legislative framework for the prevention and management of soil contamination include recognising the possible risk to both human health and ecosystems that certain agricultural and industrial activities pose given the use of organic and inorganic chemical substances of a hazardous nature and pathogenic microorganisms. It is worth highlighting the milestone that many national constitutions include about the right to the environment. This right entails the obligation to protect it and to, therefore, protect soil from any degradation, including contamination. Legislation that protects soil from contamination and, consequently human health and ecosystems, is related mainly to agricultural activities (use of sewage sludge on farmlands, use of wastewater for irrigation, use of organic fertilisers and pesticides), and to industrial and commercial soil-contaminating activities. Consumer protection may be achieved through a legal system of environmental liability, specific measures to prevent contaminants entering soil, managing contaminated soils and a food traceability system. It is crucial to make the penalties for soil contamination offenses, and for violators of protective prohibitions, effective, proportionate and dissuasive. Global standards and guidelines on soil contamination could provide national legislative systems with substantive and procedural legal mechanisms to help prevent and manage soil contamination.

Overcoming Challenges of Incorporating Higher Tier Data in Ecological Risk Assessments and Risk Management of Pesticides in the United States: Findings and Recommendations from the 2017 Workshop on Regulation and Innovation in Agriculture.

Pesticide regulation requires regulatory authorities to assess the potential ecological risk of pesticides submitted for registration, and most risk assessment schemes use a tiered testing and assessment approach. Standardized ecotoxicity tests, environmental fate studies, and exposure models are used at lower tiers and follow well-defined methods for assessing risk. If a lower tier assessment indicates that the pesticide may pose an ecological risk, higher tier studies using more environmentally realistic conditions or assumptions can be performed to refine the risk assessment and inform risk management options. However, there is limited guidance in the United States on options to refine an assessment and how the data will be incorporated into the risk assessment and risk management processes. To overcome challenges to incorporation of higher tier data into ecological risk assessments and risk management of pesticides, a workshop was held in Raleigh, North Carolina. Attendees included representatives from the United States Environmental Protection Agency, United States Department of Agriculture, National Oceanic and Atmospheric Administration, universities, commodity groups, consultants, nonprofit organizations, and the crop protection industry. Key recommendations emphasized the need for 1) more effective, timely, open communication among registrants, risk assessors, and risk managers earlier in the registration process to identify specific protection goals, address areas of potential concern where higher tier studies or assessments may be required, and if a higher tier study is necessary that there is agreement on study design; 2) minimizing the complexity of study designs while retaining high value to the risk assessment and risk management process; 3) greater transparency regarding critical factors utilized in risk management decisions with clearly defined protection goals that are operational; and 4) retrospective analyses of success-failure learnings on the acceptability of higher tier studies to help inform registrants on how to improve the application of such studies to risk assessments and the risk management process. Integr Environ Assess Manag 2019;15:714-725. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

International Regulatory and Scientific Effort for Improved Developmental Neurotoxicity Testing.

The Organisation for Economic Co-Operation and Development (OECD) coordinates international efforts to enhance developmental neurotoxicity (DNT) testing. In most regulatory sectors, including the ones dealing with pesticides and industrial chemicals registration, historical use of the in vivo DNT test guideline has been limited. Current challenges include a lack of DNT data and mechanistic information for thousands of chemicals, and difficulty in interpreting results. A series of workshops in the last decade has paved the way for a consensus among stakeholders that there is need for a DNT testing battery that relies on in vitro endpoints (proliferation, differentiation, synaptogenesis, etc.) and is complemented by alternative species (eg, zebrafish) assays. Preferably, a battery of in vitro and alternative assays should be anchored toward mechanistic relevance for applying an integrated approach for testing and assessment (IATA) framework. Specific activities have been initiated to facilitate this OECD project: the collation of available DNT in vitro methods and their scoring for readiness; the selection of these methods to form a DNT testing battery; the generation of a reference set of chemicals that will be tested using the battery; the case studies exemplifying how DNT in vitro data can be interpreted; and the development of an OECD guidance document. This manuscript highlights these international efforts and activities.

Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation.

This paper presents a comprehensive review of European Union (EU) legislation addressing the safety of chemical substances, and possibilities within each piece of legislation for applying grouping and read-across approaches for the assessment of nanomaterials (NMs). Hence, this review considers both the overarching regulation of chemical substances under REACH (Regulation (EC) No 1907/2006 on registration, evaluation, authorization, and restriction of chemicals) and CLP (Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures) and the sector-specific pieces of legislation for cosmetic, plant protection and biocidal products, and legislation addressing food, novel food, and food contact materials. The relevant supporting documents (e.g. guidance documents) regarding each piece of legislation were identified and reviewed, considering the relevant technical and scientific literature. Prospective regulatory needs for implementing grouping in the assessment of NMs were identified, and the question whether each particular piece of legislation permits the use of grouping and read-across to address information gaps was answered.

Endocrine Disruption: Current approaches for regulatory testing and assessment of plant protection products are fit for purpose.

The ongoing debate concerning the regulation of endocrine disruptors, has increasingly led to questions concerning the current testing of chemicals and whether this is adequate for the assessment of potential endocrine disrupting effects. This paper describes the current testing approaches for plant protection product (PPP) active substances in the European Union and the United States and how they relate to the assessment of endocrine disrupting properties for human and environmental health. This includes a discussion of whether the current testing approaches cover modalities other than the estrogen, androgen, thyroid and steroidogenesis (EATS) pathways, sensitive windows of exposure, adequate assessment of human endocrine disorders and wildlife species, and the determination of thresholds for endocrine disruption. It is concluded, that the scope and nature of the core and triggered data requirements for PPP active substances are scientifically robust to address adverse effects mediated through endocrine mode(s) of action and to characterise these effects in terms of dose response.

Acetylcholinesterase inhibitor insecticides related acute poisoning, availability and sales: trends during the post-insecticide-ban period of Anuradhapura, Sri Lanka.

BACKGROUND: Acetylcholinesterase inhibitor insecticides (AChEIIs) were used extensively in the agrarian region of Anuradhapura for the past few decades. As a result, the region faced a heightened risk of toxicity. Carbaryl, carbofuran, chlorpyrifos, dimethoate, and fenthion were the five hazardous AChEIIs banned from Anuradhapura in 2014. Assessment of post-ban trends in acute poisoning will reveal the impact of the ban. Data on availability and sales of remaining AChEIIs will guide towards preventive measures against related toxicities. METHODS: Cross-sectional surveys were conducted at Anuradhapura district of Sri Lanka. Details related to acute AChEII poisoning were sorted from the Teaching Hospital Anuradhapura. Main insecticide vendors in Anuradhapura were surveyed to find information on availability and sales of AChEIIs. Chi-square for goodness of fit was performed for trends in acute poisoning and sales. RESULTS: Hospital admissions related to acute AChEII poisoning have declined from 554 in 2013 to 272 in 2017. Deaths related to acute AChEII poisoning have declined from 27 in 2013 to 13 in 2017. Sales of all five banned AChEIIs had reduced by 100%. Sales of the remaining AChEIIs were declining, except for acephate, phenthoate, and profenofos. However, one of the top selling, most frequently abused carbosulfan, had the highest risk of toxicity. Chi-square for goodness of fit showed a significance (P < 0.001) between the trends of hospital admissions for acute AChEII poisoning and the sales related to AChEIIs. CONCLUSIONS: Hospital admissions related to acute poisoning was declining along with the overall sales of remaining AChEIIs, during the post-AChEII ban period. Nevertheless, future vigilance is needed on the remaining AChEIIs to predict and prevent related toxicities.

Cancelling pesticide registrations and revoking tolerances: The case of chlorpyrifos.

Petitions submitted to the United States Environmental Protection Agency (EPA) have sought to cancel registrations of chlorpyrifos and to revoke chlorpyrifos tolerances in or on food due to adverse health effects on people. Under federal law, tolerances for pesticide chemical residues in or on food must provide with reasonable certainty that no harm will result from a person's aggregate exposure. Petitioners' claims are analyzed under the legal requirements to discern whether the EPA had a rational basis for issuing its 2017 Chlorpyrifos Order denying the requests for cancellation of registrations and revocation of tolerances. The scientific evidence considered by the EPA indicated that existing tolerances do not protect people from unsafe levels of chlorpyrifos. Under the Federal Food, Drug, and Cosmetic Act, tolerances need to be revoked if they do not protect human health. In refusing to recognize that chlorpyrifos tolerances do not comply with federal law, the EPA's 2017 Chlorpyrifos Order appears to be arbitrary and capricious.

When enough data are not enough to enact policy: The failure to ban chlorpyrifos.

Strong evidence now supports the notion that organophosphate pesticides damage the fetal brain and produce cognitive and behavioral dysfunction through multiple mechanisms, including thyroid disruption. A regulatory ban was proposed, but actions to end the use of one such pesticide, chlorpyrifos, in agriculture were recently stopped by the Environmental Protection Agency under false scientific pretenses. This manuscript describes the costs and consequences of this policy failure and notes how this case study is emblematic of a broader dismissal of scientific evidence and attacks on scientific norms. Scientists have a responsibility to rebut and decry these serious challenges to human health and scientific integrity.

[The flexibilization of the Brazilian legislation on pesticides and the risks to human health: analysis of Bill of Law 3,200/2015]. / A flexibilização da legislação brasileira de agrotóxicos e os riscos à saúde humana: análise do Projeto de Lei nº 3.200/2015.

This article aims to contribute to a reflection on pesticides, based on the Brazilian legal framework, from the perspective of protecting human health and the environment. This initiative is due to successive attempts to flexibilize the regulation of pesticides in Brazil, through bills of law in progress in the Brazilian National Congress. An analysis of Bill of Law 3,200/2015 was carried out. This bill of law represents a major setback to the legislative achievements for the regulation of pesticides, in order to alert to the risks to human health from exposure to these products and aggravated by other similar proposals.

Worldwide Regulations of Standard Values of Pesticides for Human Health Risk Control: A Review.

Abstract: The impact of pesticide residues on human health is a worldwide problem, as human exposure to pesticides can occur through ingestion, inhalation, and dermal contact. Regulatory jurisdictions have promulgated the standard values for pesticides in residential soil, air, drinking water, and agricultural commodity for years. Until now, more than 19,400 pesticide soil regulatory guidance values (RGVs) and 5400 pesticide drinking water maximum concentration levels (MCLs) have been regulated by 54 and 102 nations, respectively. Over 90 nations have provided pesticide agricultural commodity maximum residue limits (MRLs) for at least one of the 12 most commonly consumed agricultural foods. A total of 22 pesticides have been regulated with more than 100 soil RGVs, and 25 pesticides have more than 100 drinking water MCLs. This research indicates that those RGVs and MCLs for an individual pesticide could vary over seven (DDT drinking water MCLs), eight (Lindane soil RGVs), or even nine (Dieldrin soil RGVs) orders of magnitude. Human health risk uncertainty bounds and the implied total exposure mass burden model were applied to analyze the most commonly regulated and used pesticides for human health risk control. For the top 27 commonly regulated pesticides in soil, there are at least 300 RGVs (8% of the total) that are above all of the computed upper bounds for human health risk uncertainty. For the top 29 most-commonly regulated pesticides in drinking water, at least 172 drinking water MCLs (5% of the total) exceed the computed upper bounds for human health risk uncertainty; while for the 14 most widely used pesticides, there are at least 310 computed implied dose limits (28.0% of the total) that are above the acceptable daily intake values. The results show that some worldwide standard values were not derived conservatively enough to avoid human health risk by the pesticides, and that some values were not computed comprehensively by considering all major human exposure pathways.

Ivermectin to reduce malaria transmission III. Considerations regarding regulatory and policy pathways.

Vector control is a task previously relegated to products that (a) kill the mosquitoes directly at different stages (insecticides, larvicides, baited traps), or (b) avoid/reduce human-mosquito contact (bed nets, repellents, house screening), thereby reducing transmission. The potential community-based administration of the endectocide ivermectin with the intent to kill mosquitoes that bite humans, and thus reduce malaria transmission, offers a novel approach using a well-known drug, but additional steps are required to address technical, regulatory and policy gaps. The proposed community administration of this drug presents dual novel paradigms; first, indirect impact on the community rather than on individuals, and second, the use of a drug for vector control. In this paper, the main questions related to the regulatory and policy pathways for such an application are identified. Succinct answers are proposed for how the efficacy, safety, acceptability, cost-effectiveness and programmatic suitability could result in regulatory approval and ultimately policy recommendations on the use of ivermectin as a complementary vector control tool.

Soil ecotoxicology in Latin America: Current research and perspectives.

Soils from some Latin American countries support the highest biodiversity levels on the planet and simultaneously have some of the most serious environmental impacts attributed to both historical and current agricultural practices and industrial activities. Soil contamination has resulted from intensive use of pesticides, extensive mining and other industrial activities, and uncontrolled management of waste within inappropriate regulatory frameworks. The present study presents an overview of the scientific research on soil ecotoxicology conducted in Latin America, summarizing the recent advances and highlighting the needs for further refinements in this research field. Most of the contributions to the scientific literature have been from Brazil. The most investigated issue is the ecotoxicity of pesticides and earthworms, which were the organisms most frequently used as test species. Needs identified by Latin American researchers include methods and procedures for: 1) identifying and collecting natural soils to be used as reference test-substrates in tests, 2) identifying and discerning the range of sensitivities of native test species to soil contaminants, 3) developing environmental guidelines applicable to tropical/subtropical conditions, and 4) developing methods and procedures for higher tier testing for full development and implementation of environmental risk assessment schemes. The protection of Latin American soils, including provision of goods and services, is currently framed in legislation and other regulations, but implementation requires significant improvement and additional training programs. Environ Toxicol Chem 2017;36:1795-1810. © 2017 SETAC.

Reflections on bird and mammal risk assessment for plant protection products in the European Union: Past, present, and future.

The use of plant protection products on agricultural crops can result in exposure of birds and mammals to toxic chemicals. In the European Union, the risks from such exposures are assessed under the current (2009) guidance document from the European Food Safety Authority (EFSA), designed to increase the realism of the theoretical risk assessments in comparison to its predecessor (SANCO/4145/2000). Since its adoption over 7 yr ago, many plant protection products have been evaluated successfully using the 2009 EFSA guidance document. However, there are still significant areas of improvement recommended for future revisions of this guidance. The present Focus article discusses experiences to date with the current scheme, including levels of conservatism in input parameters and interpretation by regulatory authorities together with proposals for how the guidance document could be improved when it is revised in the not too distant future. Several areas for which further guidance is recommended have been identified, such as the derivation of ecologically relevant bird and mammal reproductive endpoints and the use of modeling approaches to contextualize risk assessments. Areas where existing databases could be improved were also highlighted, including the collation of relevant focal species across Europe and expansion of the residue database for food items. To produce a realistic and useable guidance document in the future, it is strongly recommended that there is open and constructive communication between industry, regulatory authorities, and the EFSA. Such collaboration would also encourage harmonization between member states, thus reducing workloads for both industry and regulatory authorities. Environ Toxicol Chem 2017;36:565-575. © 2017 SETAC.

Into the void: Regulating pesticide use in Colorado's commercial cannabis markets.

BACKGROUND: In 2014, Colorado implemented the world's first seed-to-sale recreational cannabis market under a commercial model. This paper aims to provide a thick descriptive account that gives insight into the issues and complexities of Colorado's pioneering and evolving attempt to regulate the use of pesticides on commercial cannabis plantations. METHODS: The paper examines multiple data sets including: (i) Colorado State Government documents; (ii) recreational cannabis regulations; (iii) mass and niche media publications (n=175); (iv) face-to-face interviews with key stakeholders, including seniors, regulators and industry executives (n=8); and (v) field notes from relevant conferences and cultivation facility tours in Denver in October, 2016. RESULTS: Two key issues are identified. First, a public safety threat has arisen relating to application of pesticides on cannabis with intensified toxicity in concentrated products of particular concern. Second, as a pioneering jurisdiction, Colorado faces a considerable knowledge gap. To expand collective learning on this issue, for which no regulatory template and little research exists, state regulators tapped industry and other stakeholder expertise while attempting to ensure public safety goals were achieved and regulatory capture by industry was limited. CONCLUSION: Four years since the recreational cannabis market in Colorado was legalised, the State continues to grapple with the pesticide issue as testing regulations and cultivation standards are yet to be finalised. While more work is needed, Colorado has made significant progress in developing regulations relating to this complex matter. As governments of countries such as Canada and US states, including California, contemplate changes to recreational cannabis laws, Colorado's experience can assist regulators in other jurisdictions considering policy change.

Environmental risk assessment of pesticides: state of the art and prospective improvement from science.

Pesticide risk assessment in the European regulatory framework is mandatory performed for active substances (pesticides) and the plant protection products they are constituents of. The aim is to guarantee that safe use can be achieved for the intended use of the product. This paper provides a feedback on the regulatory environmental risk assessment performed for pesticide registration at the EU and member state levels. The different steps of pesticide registration are addressed considering both exposure and hazard. In this paper, we focus on the environmental fate and behaviour in surface water together with the aquatic ecotoxicity of the substances to illustrate pesticide regulatory risk assessment performed for aquatic organisms. Current methodologies are presented along with highlights on potential improvements. For instance, as regards exposure aspects, moving from field based to landscape risk assessments is promising. Regarding ecotoxicology, ecological models may be valuable tools when applied to chemical risk assessment. In addition, interest and further developments to better take into account mitigation measures in risk assessment and management are also presented.

Tobacco industry responsibility for butts: a Model Tobacco Waste Act.

Cigarette butts and other postconsumer products from tobacco use are the most common waste elements picked up worldwide each year during environmental cleanups. Under the environmental principle of Extended Producer Responsibility, tobacco product manufacturers may be held responsible for collection, transport, processing and safe disposal of tobacco product waste (TPW). Legislation has been applied to other toxic and hazardous postconsumer waste products such as paints, pesticide containers and unused pharmaceuticals, to reduce, prevent and mitigate their environmental impacts. Additional product stewardship (PS) requirements may be necessary for other stakeholders and beneficiaries of tobacco product sales and use, especially suppliers, retailers and consumers, in order to ensure effective TPW reduction. This report describes how a Model Tobacco Waste Act may be adopted by national and subnational jurisdictions to address the environmental impacts of TPW. Such a law will also reduce tobacco use and its health consequences by raising attention to the environmental hazards of TPW, increasing the price of tobacco products, and reducing the number of tobacco product retailers.

The inadequacies of pre-market chemical risk assessment's toxicity studies-the implications.

Industry provides essentially all the data for most (pre-market) chemical risk assessments (RA); academics study a chemical once it is marketed. For two randomly-chosen high production chemicals, despite new European Union mandates to evaluate all data, just 13% of the herbicide bentazon and 15% of the flame-retardant hexabromocyclododecane's published toxicity studies were found in their pre-market RA, and a systematic review on bentazon concludes it has greater hazards than indicated in its RA. More important, for both, academia's toxicity studies were designated as lower quality than industries were, despite showing hazards at lower doses. The accuracy of industry's test methods is analyzed and found to be replicable but insensitive, thus inaccurate. The synthetic pharmaceutical industry originated them, and by 1983 the Organization for Economic Cooperation & Development mandated their test guidelines (TG) methods be accepted for any new study for pre-market RA. For existing studies, industry's "Klimisch" criterion is universally used to evaluate quality, but it only states that TG studies produce the best data. However, no TG can answer the realistic exposure effect hypotheses of academics; therefore, crucially in pre-market RA, tens of thousands of published experimental findings (increasingly at low dose) are ignored to determine the safe dose. Few appreciate this, so scientific debate on the most accurate elements of toxicity tests is urgently indicated. Copyright © 2016 John Wiley & Sons, Ltd.