SUPERFUND: AN ANALYSIS OF IMPLEMENTATION FAILURE (CERCLA, HEALTH LAW POLICY)

In December, 1980, following increasing congressional and constituent-interest in problems associated with hazardous waste, the Comprehensive Environmental Recovery, Compensation and Liability Act (CERCLA) was passed. During its development, the legislative initiative was seriously compromised which resulted in a less exhaustive approach than was formerly sought. Still, CERCLA (Superfund) which established, among other things, authority to clean up abandoned waste dumps and to respond to emergencies caused by releases of hazardous substances was welcomed by many as an important initial law critical to the cleanup of the nation's hazardous waste. Expectations raised by passage of this bill were tragically unmet. By the end of four years, only six sites had been declared by the EPA as cleaned. Seemingly, even those determinations were liberal; of the six sites, two were identified subsequently as requiring further cleanup.^ This analysis is focused upon the implementation failure of the Superfund. In light of that focus, discussion encompasses development of linkages between flaws in the legislative language and foreclosure of chances for implementation success. Specification of such linkages is achieved through examination of the legislative initiative, identification of its flaws and characterization of attendant deficits in implementation ability. Subsequent analysis is addressed to how such legislative frailities might have been avoided and to attendant regulatory weaknesses which have contributed to implementation failure. Each of these analyses are accomplished through application of an expanded approach to the backward mapping analytic technique as presented by Elmore. Results and recommendations follow.^ Consideration is devoted to a variety of regulatory issues as well as to those pertinent to legislative and implementation analysis. Problems in assessing legal liability associated with hazardous waste management are presented, as is a detailed review of the legislative development of Superfund, and its initial implementation by Gorsuch's EPA. ^

Implications of Health Care Reform (Medical Ethics Series, 2011)

A video of a panel discussion on how Obama's Health Care Reform would affect Texas Medical Center institutions and health care in general.Speakers include Tom Cole (moderator), Roberta Schwartz (Methodist Hospital), Pauline Rosenau (UT-Houston School of Public Health), and Laurence McCullough (Baylor College of Medicine).

The public health applications of law enforcement medical direction: A practical experience with the Dallas Police Department

In 2008, 132 law enforcement officers were killed in the line of duty in The United States. Additionally, some have explored both the public health implications of interactions with law enforcement as well as the potential benefits of the use of law enforcement officers as public health and emergency healthcare providers. By virtue of these novel analyses and techniques, professional medical direction of the emerging specialty of law enforcement medicine is needed. This paper, an analysis of law enforcement medical direction through a look at the Dallas Police Medical Direction Program, seeks to examine origins of law enforcement medicine through a comprehensive literature review, as well as begin to define to core competencies of law enforcement medical direction. ^ The unique intersection of public health, medicine and law enforcement, and the subsequent specialty that is developing to manage this interface, is in its relative infancy. An analysis of this nature is in order to begin to lay down the foundations necessary for future study and improvements in the field. ^

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Environmental, health and safety cost benefit analysis in the United States chemical industry

The purpose of this research project is to determine whether there is a cost/benefit to allocating financial and other company-related resources to improve environmental, health and safety performance beyond that which is required by law. The issue of whether a company benefits from spending dollars to achieve environmental, health and safety performance beyond legal compliance is an important issue to the chemical manufacturing industry in the United States because of the voluminous and complex legal requirements impacting environmental, health and safety expenditures. The cost/benefit issue has practical significance because many U.S. chemical manufacturing companies base their environmental, health and safety management strategies on just achieving and maintaining compliance with legal requirements when in reality this strategy may actually be a higher cost way of managing environmental, health and safety practices. This difference in environmental, health and safety management strategy is being investigated to determine if managing environmental, health and safety to achieve performance beyond that which is required by law results in a greater benefit to companies in the U.S. chemical manufacturing sector.

Achieving effective biosurveillance with the Nationwide Health Information Network

The federal government is currently developing the Nationwide Health Information Network (NHIN). Described as a “network of networks,” the NHIN seeks to provide a nationwide, interoperable health information infrastructure that will securely connect consumers with those involved in health care. As part of the national health information technology (HIT) agenda, the NHIN aims to improve individual and population health by enabling health information to follow the consumer, be available for clinical decision-making, and support important public health measures such as biosurveillance. While the NHIN promises to improve clinical care to individuals and to reduce U.S. health care system costs overall, this electronic environment presents novel challenges for protecting individually identifiable health information. A major barrier to achieving public trust in the NHIN is the development of, and adherence to, a consistent and coordinated approach to privacy and security of health information. This paper will analyze the policy framework for electronic health information exchange with the NHIN. This exercise will demonstrate that the current policy is an effective framework for achieving effective biosurveillance with the NHIN. ^

Industrial benzene emissions in Houston: Legal barriers to reducing a public health threat

Decades of research show that environmental exposure to the chemical benzene is associated with severe carcinogenic, hematoxic and genotoxic effects on the human body. As such, the Environmental Protection Agency (EPA) has designated the chemical as a Hazardous Air Pollutant and prescribed benzene air concentration guidelines that provide cities with an ideal ambient level to protect human health. However, in Houston, Texas, a city home to the top industrial benzene emitters in the US who undoubtedly contribute greatly to the potentially unsafe levels of ambient benzene, regulations beyond the EPA’s unenforceable guidelines are critical to protecting public health. Despite this, the EPA has failed to establish National Ambient Air Quality Standards (NAAQS) for benzene. States are thus left to regulate air benzene levels on their own; in the case of Texas, the Texas Commission on Environmental Quality (TCEQ) and state legislature have failed to proactively develop legally enforceable policies to reduce major source benzene emissions. This inaction continues to exacerbate a public health problem, which may only be solved through a legal framework that restricts preventable benzene emissions to protect human health and holds industrial companies accountable for violations of such regulations and standards. This analysis explores legal barriers that the City of Houston and other relevant agencies currently face in their attempt to demand and bring about such change. ^

Environmental tobacco smoke exposure, respiratory and cardiovascular health in restaurant and bar workers in Mexico

Environmental tobacco smoke (ETS) is a well established health hazard, being causally associated to lung cancer and cardiovascular disease. ETS regulations have been developed worldwide to reduce or eliminate exposure in most public places. Restaurants and bars constitute an exception. Restaurants and bar workers experience the highest ETS exposure levels across several occupations, with correspondingly increased health risks. In Mexico, previous exposure assessment in restaurants and bars showed concentrations in bars and restaurants to be the highest across different public and workplaces. Recently, Mexico developed at the federal level the General Law for Tobacco Control restricting indoors smoking to separated areas. AT the local level Mexico City developed the Law for the Protection of Non-smokers Health, completely banning smoking in restaurants and bars. Studies to assess ETS exposure in restaurants and bars, along with potential health effects were required to evaluate the impact of these legislative changes and to set a baseline measurement for future evaluations.^ A large cross-sectional study conducted in restaurants and bars from four Mexican cities was conducted from July to October 2008, to evaluate the following aims: Aim 1) Explore the potential impact of the Mexico City ban on ETS concentrations through comparison of Mexico City with other cities. Aim 2). Explore the association between ETS exposure, respiratory function indicators and respiratory symptoms. Aim 3). Explore the association between ETS exposure and blood pressure and heart rate.^ Three cities with no smoking ban were selected: Colima (11.5% smoking prevalence), Cuernavaca (21.5% smoking prevalence) and Toluca (27.8% smoking prevalence). Mexico City (27.9% smoking prevalence), the only city with a ban at the time of the study, was also selected. Restaurants and bars were randomly selected from municipal records. A goal of 26 restaurants and 26 bars per city was set, 50% of them under 100 m2. Each establishment was visited during the highest occupancy shift, and managers and workers answered to a questionnaire. Vapor-phase nicotine was measured using passive monitors, that were activated at the beginning and deactivated at the end of the shift. Also, workers participated at the beginning and end of the shift in a short physical evaluation, comprising the measurement of Forced Expiratory Volume in the first second (FEV1) and Peak Expiratory Flow (PEF), as well as blood pressure and heart rate.^ A total of 371 establishments were invited, 219 agreed to participate for a 60.1% participation rate. In them, 828 workers were invited, 633 agreed to participate for a 76% participation rate. Mexico City had at least 4 times less nicotine compared to any of the other cities. Differences between Mexico City and other cities were not explained by establishment characteristics, such as ventilation or air extraction. However, differences between cities disappeared when ban mechanisms, such as policy towards costumer's smoking, were considered in the models. An association between ETS exposure and respiratory symptoms (cough OR=1.27, 95%CI=1.04, 1.55) and respiratory illness (asthma OR=1.97, 95%CI=1.20, 3.24; respiratory illness OR=1.79, 95%CI=1.10, 2.94) was observed. No association between ETS and phlegm, wheezing or respiratory infections was observed. No association between ETS and any of the spirometric indicators was observed. An association between ETS exposure and increased systolic and diastolic blood pressure at the end of the shift was observed among non-smokers (systolic blood pressure beta=1.51, 95%CI=0.44, 2.58; diastolic blood pressure beta=1.50, 95%CI=0.72, 2.28). The opposite effect was observed in heavy smokers, were increased ETS exposure was associated with lower blood pressure at the end of the shift (systolic blood pressure beta=1.90, 95%CI=-3.57, -0.23; diastolic blood pressure beta=-1.46, 95%CI=-2.72, -0.02). No association in light smokers was observed. No association for heart rate was observed. ^ Results from this dissertation suggest Mexico City's smoking ban has had a larger impact on ETS exposure. Ventilation or air extraction, mechanisms of ETS control suggested frequently by tobacco companies to avoid smoking bans were not associated with ETS exposure. This dissertation suggests ETS exposure could be linked to changes in blood pressure and to increased respiratory symptoms. Evidence derived from this dissertation points to the potential negative health effects of ETS exposure in restaurants and bars, and provides support for the development of total smoking bans in this economic sector. ^

Texas Health & Safety Code, Section 165.002 - Right to Breastfeed in Texas

The language used in Section 165.002 of the Texas Health and Safety Code renders breastfeeding women vulnerable and susceptible to harassment, discrimination, and persecution via the Texas Penal Code, Sec. 30.05 (Criminal Trespassing), Sec. 21.08 (Indecent Exposure), and Sec. 21.22 (Indecency with a Child). ^ The overall goal of this paper is to develop a solution to this problem via a proposed law or legislative action that offers protection and support for breastfeeding women who choose to nurse in public. Data to inform these recommendations were collected through a literature review and structured interviews with several breastfeeding stakeholders. A literature review of state and federal breastfeeding legislation was conducted to compare and contrast differences between existing legislation in the United States. Interviews were conducted with breastfeeding legislation stakeholders, which included state legislators who have been active in breastfeeding legislation, breastfeeding mothers, and representatives from the Central Texas Healthy Mothers Healthy Babies Coalition (Centex HMHB Coalition), Texas Breastfeeding Coalition (TXBF coalition), La Leche League International, and the Texas Business Association. Data from the literature and legislation reviews and interviews were transcribed and examined for common themes using qualitative data techniques. ^ Overall, most of the stakeholders came to a general consensus on three points, (1) breastfeeding women are supported by stakeholders within the community, (2) other legislation or penal codes should not override the right to breastfeed, and (3) the current breastfeeding legislation needs to be improved to adequately support breastfeeding women. The interviews with breastfeeding legislation stakeholders yielded two major recommendations for the improvement of Section 165.002 of the Texas Health and Safety Code: advocacy efforts to change the wording of the legislation and education to inform people about the legislation. ^ The right to breastfeed is an important public health issue in that it provides a host of health benefits for mothers and children, and is more economical and environmentally superior to alternative feeding methods. While breastfeeding in public is not illegal nor ever has been, adequate legislation is important to affirm this right for women so that they can confidently feed their children without embarrassment or harassment.^

PROJECTION OF HEALTH DEMAND IN TERMS OF HOSPITAL ADMISSIONS FOR SELECTED DIAGNOSES IN HEALTH SYSTEMS AGENCY SERVICE AREAS

The National Health Planning and Resources Development Act of 1974 (Public Law 93-641) requires that health systems agencies (HSAs) plan for their health service areas by the use of existing data to the maximum extent practicable. Health planning is based on the identificaton of health needs; however, HSAs are, at present, identifying health needs in their service areas in some approximate terms. This lack of specificity has greatly reduced the effectiveness of health planning. The intent of this study is, therefore, to explore the feasibility of predicting community levels of hospitalized morbidity by diagnosis by the use of existing data so as to allow health planners to plan for the services associated with specific diagnoses.^ The specific objectives of this study are (a) to obtain by means of multiple regression analysis a prediction equation for hospital admission by diagnosis, i.e., select the variables that are related to demand for hospital admissions; (b) to examine how pertinent the variables selected are; and (c) to see if each equation obtained predicts well for health service areas.^ The existing data on hospital admissions by diagnosis are those collected from the National Hospital Discharge Surveys, and are available in a form aggregated to the nine census divisions. When the equations established with such data are applied to local health service areas for prediction, the application is subject to the criticism of the theory of ecological fallacy. Since HSAs have to rely on the availability of existing data, it is imperative to examine whether or not the theory of ecological fallacy holds true in this case.^ The results of the study show that the equations established are highly significant and the independent variables in the equations explain the variation in the demand for hospital admission well. The predictability of these equations is good when they are applied to areas at the same ecological level but become poor, predominantly due to ecological fallacy, when they are applied to health service areas.^ It is concluded that HSAs can not predict hospital admissions by diagnosis without primary data collection as discouraged by Public Law 93-641. ^

Legal regulation of the food industry as a public health measure

Background. The Food and Drug Administration (FDA) is an agency of the federal government that is responsible for monitoring and maintaining public health through the regulation of many industries, including food safety. Through the Nutrition Labeling and Education Act of 1990, the FDA was granted authority over the implementation and regulation of nutrition labeling on packaged foods. Many nutrients are printed on nutrition labels as well as their percent Daily Values. Research has been undertaken to examine the evidentiary basis the FDA relied upon in making its determinations regarding which nutrients to include on nutrition labels as well as their Daily Values. ^ Methods. Relevant legal policies, scientific studies, and other published literature (either in print or electronic form) were used to collect data. ^ Results. Results demonstrated that the FDA did not employ one single method in its determination of which nutrients to select for inclusion on food labels. The agency relied upon current public heath studies of that time as well as recommendations from the U.S. Surgeon General.^