Evaluating health risks from occupational exposure to pesticides and the regulatory response.

In this study, we used measurements of occupational exposures to pesticides in agriculture to evaluate health risks and analyzed how the federal regulatory program is addressing these risks. Dose estimates developed by the State of California from measured occupational exposures to 41 pesticides were compared to standard indices of acute toxicity (LD50) and chronic effects (reference dose). Lifetime cancer risks were estimated using cancer potencies. Estimated absorbed daily doses for mixers, loaders, and applicators of pesticides ranged from less than 0.0001% to 48% of the estimated human LD50 values, and doses for 10 of 40 pesticides exceeded 1% of the estimated human LD50 values. Estimated lifetime absorbed daily doses ranged from 0.1% to 114,000% of the reference doses developed by the U.S. Environmental Protection Agency, and doses for 13 of 25 pesticides were above them. Lifetime cancer risks ranged from 1 per million to 1700 per million, and estimates for 12 of 13 pesticides were above 1 per million. Similar results were obtained for field workers and flaggers. For the pesticides examined, exposures pose greater risks of chronic effects than acute effects. Exposure reduction measures, including use of closed mixing systems and personal protective equipment, significantly reduced exposures. Proposed regulations rely primarily on requirements for personal protective equipment and use restrictions to protect workers. Chronic health risks are not considered in setting these requirements. Reviews of pesticides by the federal pesticide regulatory program have had little effect on occupational risks. Policy strategies that offer immediate protection for workers and that are not dependent on extensive review of individual pesticides should be pursued.     

The tobacco industry's political efforts to derail the EPA report on ETS

Previously secret tobacco industry documents detailed a multifaceted approach of political strategies aimed to derail the 1993 Environmental Protection Agency (EPA) risk assessment on environmental tobacco smoke (ETS). These pervasive strategies included the following: (1) lobbying the first Bush Administration to approve an executive order that would impose new risk assessment standards for federal agencies, thus delaying the release of the EPA report; (2) having the first Bush Administration transfer jurisdiction over ETS from the EPA to Occupational Safety and Health Administration (OSHA), thus obviating the need for the release of the EPA report; and (3) applying enormous political pressure directly by alleging improper procedure and policy at EPA. Although some of the attempted strategies failed, the political pressure from Congressman Thomas Bliley (R-VA) was a success. This is the first report showing how a single member of Congress in conjunction with his staff, tobacco industry attorneys, and executives worked very aggressively to do the tobacco industry's bidding. These tactics successfully delayed the EPA risk assessment and placed a cloud over its validity that was not fully vindicated until December 2002 when the U.S. 4th Circuit Court of Appeals overturned the tobacco industry's suit against the EPA. The documents show that the industry will expend whatever effort is necessary to protect itself from public health policy that would adversely affect consumption of cigarettes and, therefore, profit.     

The ethics of industry experimentation using employees: the case of taste-testing pesticide-treated tobacco

In the United States, companies that use their own funds to test consumer products on their employees are subject to few regulations. Using previously undisclosed tobacco industry documents, we reviewed the history of that industry's efforts to create internal guidelines on the conditions to be met before employee taste testers could evaluate cigarettes made from tobacco treated with experimental pesticides.This history highlights 2 potential ethical issues raised by unregulated industrial research: conflict of interest and lack of informed consent. To ensure compliance with accepted ethical standards, an independent federal office should be established to oversee industrial research involving humans exposed to experimental or increased quantities of ingested, inhaled, or absorbed chemical agents.     

Hungry for Hungary: examples of tobacco industry's expansionism

OBJECTIVE: To give an overview of available internal tobacco industry documents on the transnational tobacco companies' (TTCs) efforts to enter the new market of the emerging democracy of Hungary and how it developed allies in its efforts at resisting tobacco control regulations. METHOD: Internal tobacco industry documents relevant to Hungary, available on the World Wide Web, were searched between 26 July and 30 November 2001. Documents on the identification of Central and Eastern Europe (CEE) as a great market potential have been reviewed; another set of reviewed documents are of particular relevance to Hungary, as they indicate who the main partners of the industry are. CONCLUSIONS: TTCs not only invaded the markets of the fragile new CEE democracies by making their product widely available, but also introduced sophisticated lobbying and marketing tactics. TTCs will try to shape the country's regulatory framework in a manner to help increase their profits. The fiercer the reaction of TTCs against a planned regulatory measure is, the more impact on the health of the population could be expected from the introduction and enforcement of that measure.     

Breaking the alliance: Defeating the tobacco industry's allies and enacting youth access restrictions in Massachusetts

OBJECTIVES: We describe the tobacco industry's effort in Massachusetts to block the adoption of local regulations designed to reduce youth access to tobacco products. We also explain how state-funded tobacco control advocates overcame industry opposition. METHODS: We examined internal tobacco industry documents and records of local boards of health and conducted interviews with participants in local regulatory debates. RESULTS: The industry fought proposed regulations by working through a trade group, the New England Convenience Store Association. With industry direction and financing, the association's members argued against proposed regulations in local public hearings. However, these efforts failed because community-based advocates worked assiduously to cultivate support for the regulations among board of health members and local community organizations. CONCLUSIONS: Passage of youth access regulations by local boards of health in Massachusetts is attributed to ongoing state funding for local tobacco control initiatives, agreement on common policy goals among tobacco control advocates, and a strategy of persuading boards of health to adopt and enforce their own local regulations.     

Managing pesticide chronic health risks: U.S. policies

This paper provides an overview of U.S. government pesticide risk management efforts over time and in recent years, relevant to chronic health risks of pesticides. Pesticides are in widespread usage in the U.S. With hundreds of active ingredients and thousands of products on the market, management of pesticide risks has been a daunting challenge. The first legislation providing federal authority for regulating pesticides was enacted in 1910. With the establishment of the U.S. Environmental Protection Agency in 1970 and amendments to the pesticide law in 1972, the federal government was for the first time given the authority to regulate health and environmental risks of pesticides. However, older pesticide risks were not addressed until legislation was enacted in 1988, requiring "reregistration" and 1996, requiring that pesticide food standards are safe for children. In result, the U.S. has seen an expansion of development of pesticide products that are registered as "reduced risk" or are biologicals. Additionally a large number of older pesticides have been cancelled or reduced from the market and/or from individual food uses. Through biomonitoring data, the U.S. may now be seeing trends in reduction of exposure to certain pesticides, the organophosphate insecticides. However, pesticide sales data through 2001 do not provide evidence for such trends.     

The creation of industry front groups: the tobacco industry and "get government off our back"

We investigated how industries use front groups to combat public health measures by analyzing tobacco industry documents, contemporaneous media reports, journal articles, and press releases regarding "Get Government Off Our Back," a coalition created by the tobacco industry. RJ Reynolds created Get Government Off Our Back in 1994 to fight federal regulation of tobacco. By keeping its involvement secret, RJ Reynolds was able to draw public and legislative support and to avoid the tobacco industry reputation for misrepresenting evidence. The tobacco industry is not unique in its creation of such groups. Research on organizational background and funding could identify other industry front groups. Those who seek to establish measures to protect public health should be prepared to counter the argument that government should not regulate private behavior.     

Policy implications of genetic information on regulation under the Clean Air Act: the case of particulate matter and asthmatics

The U.S. Clean Air Act (CAA) explicitly guarantees the protection of sensitive human subpopulations from adverse health effects associated with air pollution exposure. Identified subpopulations, such as asthmatics, may carry multiple genetic susceptibilities to disease onset and progression and thus qualify for special protection under the CAA. Scientific advances accelerated as a result of the groundbreaking Human Genome Project enable the quantification of genetic information that underlies such human variability in susceptibility and the cellular mechanisms of disease. In epidemiology and regulatory toxicology, genetic information can more clearly elucidate human susceptibility essential to risk assessment, such as in support of air quality regulation. In an effort to encourage the incorporation of genomic information in regulation, the U.S. Environmental Protection Agency (EPA) has issued an Interim Policy on Genomics. Additional research strategy and policy documents from the National Academy of Science, the U.S. EPA, and the U.S. Department of Health and Human Services further promote the expansion of asthma genetics research for human health risk assessment. Through a review of these government documents, we find opportunities for the inclusion of genetic information in the regulation of air pollutants. In addition, we identify sources of information in recent scientific research on asthma genetics relevant to regulatory standard setting. We conclude with recommendations on how to integrate these approaches for the improvement of regulatory health science and the prerequisites for inclusion of genetic information in decision making.     

An overview of EPA regulation of the safe disposal of transuranic waste at the Waste Isolation Pilot Plant

In March of 1999, the Waste Isolation Pilot Plant (WIPP) in southeast New Mexico, the world's first deep geological repository for radioactive materials, began receiving defense-related transuranic waste. The WIPP was designed and constructed by the U.S. Department of Energy, but critical to its opening was certification by the U.S. Environmental Protection Agency that the repository complies with the radioactive waste disposal regulations set forth as environmental radiation protection standards (40 CFR Part 191) and compliance criteria (40 CFR Part 194). This paper provides a summary of the regulatory process, including the Environmental Protection Agency's waste containment, groundwater protection, and individual dose regulations for the WIPP; the Department of Energy's performance assessment and the other parts of its compliance certification application; and the Environmental Protection Agency's review and analysis of the compliance certification application and related documentation.     

Secret ties to industry and conflicting interests in cancer research

BACKGROUND: Recently it was reported that a Swedish professor in environmental health has for decades worked as a consultant for Philip Morris without reporting his employment to his academic employer or declaring conflicts of interest in his research. The potential for distorting the epidemiological assessments of hazard and risk through paid consultants, pretending to be independent, is not exclusive to the tobacco industry. METHODS: Documentation is drawn from peer reviewed publications, websites, documents from the Environmental Protection Agency, University reports, Wellcome Library Special Collections and the Washington Post. RESULTS: Some consulting firms employ university researchers for industry work thereby disguising industry links in the income of large departments. If the industry affiliation is concealed by the scientist, biases from conflicting interests in risk assessments cannot be evaluated and dealt with properly. Furthermore, there is reason to suspect that editors and journal staff may suppress publication of scientific results that are adverse to industry owing to internal conflict of interest between editorial integrity and business needs. CONCLUSIONS: Examples of these problems from Sweden, UK, and USA are presented. The shortfalls cited in this article illustrate the need for improved transparency, regulations that will help curb abuses as well as instruments for control and enforcement against abuses.     

Aldicarb as a cause of food poisoning--Louisiana, 1998

Cholinesterase-inhibiting pesticides (i.e., organic phosphates and carbamates), widely used in agriculture, can cause illness if they contaminate food or drinking water. Aldicarb, a regulated carbamate pesticide, is highly toxic, and the U.S. Environmental Protection Agency (EPA) requires applicators to be trained and certified. This report describes a foodborne outbreak of aldicarb poisoning that occurred when improperly stored and labeled aldicarb was used mistakenly in food preparation.     

European Union bans atrazine, while the United States negotiates continued use

Atrazine is a common agricultural herbicide with endocrine disruptor activity. There is evidence that it interferes with reproduction and development, and may cause cancer. Although the U.S. Environmental Protection Agency (EPA) approved its continued use in October 2003, that same month the European Union (EU) announced a ban of atrazine because of ubiquitous and unpreventable water contamination. The authors reviewed regulatory procedures and government documents, and report efforts by the manufacturer of atrazine, Syngenta, to influence the U.S. atrazine assessment, by submitting flawed scientific data as evidence of no harm, and by meeting repeatedly and privately with EPA to negotiate the government's regulatory approach. Many of the details of these negotiations continue to be withheld from the public, despite EPA regulations and federal open-government laws that require such decisions to be made in the open.     

Pesticide exposure beliefs among Latino farmworkers in North Carolina's Christmas tree industry

BACKGROUND: Pesticide exposure is a major preventable occupational hazard for farmworkers. This study examined the beliefs of Latino farmworkers in North Carolina's Christmas tree industry regarding pesticide exposure. METHODS: In-depth interviews were conducted with 20 Mexican male seasonal farmworkers. Participants discussed beliefs about agricultural chemicals, routes of exposure, and health effects of these chemicals. They also discussed their knowledge and use of pesticide safety practices and safety training received. RESULTS: Most farmworkers knew that pesticides could be harmful, though workers varied in their levels of knowledge regarding routes of exposure, specific health effects of pesticides, and ways to avoid and reduce exposure. Workers varied considerably in the amount of safety training received and use of safety practices. Perceived lack of control and health beliefs were salient factors that decreased workers' use of safety practices. CONCLUSIONS: This study adds to the growing body of research which documents the health beliefs of Latino farmworkers in the U.S. relative to pesticides and pesticide safety. This literature is beginning to show convergence on several points (e.g., farmworker knowledge of acute vs. long-term illness resulting from pesticide exposure), as well as regional variation in pesticide safety beliefs. This study substantiates the need for pesticide safety education to address issues of control as well as beliefs.     

Identifying carcinogens: the tobacco industry and regulatory politics in the United States.

The process of identifying carcinogens for purposes of health and safety regulation has been contested internationally. The U.S. government produces a "Report on Carcinogens" every two years, which lists known and likely human carcinogenic substances. In the late 1990s the tobacco industry responded to the proposed listing of secondhand smoke with a multi-part strategy. Despite industry efforts to challenge both the substance of the report and the agency procedures, environmental tobacco smoke was declared by the agency in 2000 to be a known human carcinogen. A subsequent lawsuit, launched by chemical interests but linked to the tobacco industry, failed, but it produced a particular legal precedent of judicial review that is favorable to all regulated industries. The authors argue that, in this case, tobacco industry regulation contradicts academic expectations of business regulatory victories. However, the tobacco industry's participation in the regulatory process influenced the process in favor of all regulated industry.     

Tobacco industry documents from outside sources: new perspectives on industry strategies on local levels

The internal tobacco industry documents have also been used to study tobacco industry operations outside the United States. The scope of the documents on a country outside the US is decided mainly by the extent to which documents and reports were transmitted from the abroad offices of the US tobacco companies to headquarters. We explored whether the material from a private archive of a Finnish public relation consultant to Philip Morris will augment or revise the earlier reports on tobacco industry manipulation in Finland. The private records add more details to previously published reports. The new information mainly concerned implementation of the tobacco industry strategies. A general conclusion is that tobacco industry documents may not give a detailed picture of tobacco industry activities in distant markets, which would be of interest locally, even if they provide sufficient information to convey a general view of tobacco industry strategies.     

Human testing of pesticides: ethical and scientific considerations

I reviewed ethical and scientific aspects of 6 human pesticide-dosing studies submitted to the Environmental Protection Agency (EPA) for consideration during the pesticide reregistration process. All had serious ethical or scientific deficiencies-or both-including unacceptable informed consent procedures, unmanaged financial conflicts of interest, inadequate statistical power, inappropriate test methods and endpoints, and distorted results. Given today's knowledge of the effects of pesticides, there is no assurance that any such study can be completely free of short-term risks, long-term risks, or both. Therefore, there is no basis for allowing pesticide studies to continue or for using them during the pesticide reregistration process. An EPA committee that is free from political and financial conflicts of interest should review this practice.     

The smoke you don't see: uncovering tobacco industry scientific strategies aimed against environmental tobacco smoke policies

OBJECTIVES: This review details the tobacco industry's scientific campaign aimed against policies addressing environmental tobacco smoke (ETS) and efforts to undermine US regulatory agencies from approximately 1988 to 1993. METHODS: The public availability of more than 40 million internal, once-secret tobacco company documents allowed an unedited and historical look at tobacco industry strategies. RESULTS: The analysis showed that the tobacco industry went to great lengths to battle the ETS issue worldwide by camouflaging its involvement and creating an impression of legitimate, unbiased scientific research. CONCLUSIONS: There is a need for further international monitoring of industry-produced science and for significant improvements in tobacco document accessibility.     

Pesticide testing in humans: ethics and public policy

Pesticide manufacturers have tested pesticides increasingly in human volunteers over the past decade. The apparent goal of these human studies is to establish threshold levels for symptoms, termed "no observed effect levels." Data from these studies have been submitted to the U.S. Environmental Protection Agency (EPA) for consideration in standard setting. There are no required ethical guidelines for studies of pesticides toxicity conducted in humans, no governmental oversight is exercised, and no procedures have been put in place for the protection of human subjects. To examine ethical and policy issues involved in the testing of pesticides in humans and the use of human data in standard setting, in February 2002 the Center for Children's Health and the Environment of the Mount Sinai School of Medicine convened an expert workshop for ethicists, physicians, toxicologists, and policy analysts. After a peer consensus process, participants developed a number of ethical and public policy recommendations regarding the testing of pesticides in humans. Participants also strongly encouraged active biomonitoring of every pesticide currently in use to track human exposure, particularly in vulnerable populations, and to assess adverse effects on health.     

Cumulative organophosphate pesticide exposure and risk assessment among pregnant women living in an agricultural community: a case study from the CHAMACOS cohort

Approximately 230,000 kg of organophosphate (OP) pesticides are applied annually in California's Salinas Valley. These activities have raised concerns about exposures to area residents. We collected three spot urine samples from pregnant women (between 1999 and 2001) enrolled in CHAMACOS (Center for the Health Assessment of Mothers and Children of Salinas), a longitudinal birth cohort study, and analyzed them for six dialkyl phosphate metabolites. We used urine from 446 pregnant women to estimate OP pesticide doses with two deterministic steady-state modeling methods: method 1, which assumed the metabolites were attributable entirely to a single diethyl or dimethyl OP pesticide; and method 2, which adapted U.S. Environmental Protection Agency (U.S. EPA) draft guidelines for cumulative risk assessment to estimate dose from a mixture of OP pesticides that share a common mechanism of toxicity. We used pesticide use reporting data for the Salinas Valley to approximate the mixture to which the women were exposed. Based on average OP pesticide dose estimates that assumed exposure to a single OP pesticide (method 1), between 0% and 36.1% of study participants' doses failed to attain a margin of exposure (MOE) of 100 relative to the U.S. EPA oral benchmark dose(10) (BMD(10)), depending on the assumption made about the parent compound. These BMD(10) values are doses expected to produce a 10% reduction in brain cholinesterase activity compared with background response in rats. Given the participants' average cumulative OP pesticide dose estimates (method 2) and regardless of the index chemical selected, we found that 14.8% of the doses failed to attain an MOE of 100 relative to the BMD(10) of the selected index. An uncertainty analysis of the pesticide mixture parameter, which is extrapolated from pesticide application data for the study area and not directly quantified for each individual, suggests that this point estimate could range from 1 to 34%. In future analyses, we will use pesticide-specific urinary metabolites, when available, to evaluate cumulative OP pesticide exposures.