US Public Law Research Articles

Developing Evidence to Support Policy: Protocol for the StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT).

All federal agencies are required to support appropriation requests with evidence and evaluation (US Public Law 115-435; the Evidence Act). The StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT) is 1 of 6 centers that help the Department of Veterans Affairs (VA) meet this requirement. Working with the existing VA evaluation structure, SALIENT evaluations will contribute to (1) optimize policies and programs for veteran populations; (2) improve outcomes regarding health, equity, cost, and provider well-being; (3) advance the science of dissemination and knowledge translation; and (4) expand the implementation and dissemination science workforce. We leverage the Lean Sprint methodology (iterative, incremental, rule-governed approach to clearly defined, and time-boxed work) and 3 cores to develop our evaluation plans collaboratively with operational partners and key stakeholders including veterans, policy experts, and clinicians. The Operations Core will work with evaluation teams to develop timelines, facilitate work, monitor progress, and guide quality improvement within SALIENT. The Methods Core will work with evaluation teams to identify the most appropriate qualitative, quantitative, and mixed methods approaches to address each evaluation, ensure that the analyses are conducted appropriately, and troubleshoot when problems with data acquisition and analysis arise. The Knowledge Translation (KT) Core will target key partners and decision makers using a needs-based market segmentation approach to ensure that needs are incorporated in the dissemination of knowledge. The KT Core will create communications briefs, playbooks, and other materials targeted at these market segments to facilitate implementation of evidence-based practices and maximize the impact of evaluation results. The SALIENT team has developed a center infrastructure to support high-priority evaluations, often to be responsive to shifting operational needs and priorities. Our team has engaged in our core missions and operations to rapidly evaluate a high-priority areas, develop a comprehensive Lean Sprint systems redesign approach to training, and accelerate rapid knowledge translation. With an array of interdisciplinary expertise, operational partnerships, and integrated resources, SALIENT has an established and evolving infrastructure to rapidly develop and implement high-impact evaluations. Projects are developed with sustained efficiency approaches that can pivot to new priorities as needed and effectively translate knowledge for key stakeholders and policy makers, while creating a learning health system infrastructure to foster the next generation of evaluation and implementation scientists. PRR1-10.2196/59830.

Cumulative Blast Impulse Is Predictive for Changes in Chronic Neurobehavioral Symptoms Following Low Level Blast Exposure during Military Training.

Cumulative low-level blast exposure during military training may be a significant occupational hazard, increasing the risk of poor long-term outcomes in brain function. US Public Law 116-92 section717 mandates that US Department of Defense agencies document the blast exposure of each Service member to help inform later disability and health care decisions. However, which empirical measures of training blast exposure, such as the number of incidents, peak overpressure, or impulse, best inform changes in the neurobehavioral symptoms reflecting brain health have not been established. This study was approved by the US Army Special Operations Command, the University of North Carolina at Chapel Hill, and the VA Puget Sound Health Care System. Using methods easily deployable across different organizational structures, this study sought to identify and measure candidate risk factors related to career occupational blast exposure predictive of changes in neurobehavioral symptom burden. Blast dosimetry-symptom relationships were first evaluated in mice and then tested in a military training environment. In mice, the righting time neurobehavioral response was measured after exposure to a repetitive low-level blast paradigm modeled after Special Operations training. In the military training environment, 23 trainees enrolled in a 6-week explosive breaching training course, 13 instructors, and 10 Service member controls without blast exposure participated in the study (46 total). All participants provided weekly Neurobehavioral Symptom Inventory (NSI) surveys. Peak blast overpressure, impulse, total number of blasts, Time in Low-Level Blast Occupation, and Time in Service were analyzed by Bayesian analysis of regression modeling to determine their probability of influence on the post-training symptoms reported by participants. We tested the hypothesis that cumulative measures of low-level blast exposure were predictive of changes in neurobehavioral symptoms. In mice, repetitive blast resulted in reduced righting times correlated with cumulative blast impulse. In Service members, peak blast overpressure, impulse, total number of blasts, Time in Low-Level Blast Occupation, and Time in Service all showed strong evidence of influence on NSI scores after blast exposure. However, only models including baseline NSI scores and cumulative blast impulse provided significant predictive value following validation. These results indicate that measures of cumulative blast impulse may have utility in predicting changes in NSI scores. Such paired dosimetry-symptom measures are expected to be an important tool in safely guiding Service members' occupational exposure and optimizing force readiness and lethality.

Standardizing States of Emergency: Fragmented Legitimacy of Model Public Health Lawmaking

The promulgation of model laws—exemplary statutes that states can voluntarily choose to adopt—is a prominent strategy that reformers in public health agencies, the legal academy, and non governmental organizations use to improve US public health law and make it more uniform. This article applies the science and technology studies literature on standardization to the process of model lawmaking to analyze how developers negotiate between alternative forms of expertise and utilize different drafting processes to secure the techno-political legitimacy of their model statutes. Drawing on archival records and interviews with thirty-four experts involved in the development of four model public health laws produced between 1999 and 2007, I show how developers work to satisfy multiple, and, at times, competing, audiences. I observe that developers leveraged forms of legal expertise to secure their model laws’ technical legitimacy and emphasized their objectivity, representativeness, and flexibility to promote their political legitimacy. Comparing the four model laws across several indicia of legitimacy, I find that the developers experienced varying degrees of success. This study contributes to the socio legal scholarship on model laws by revealing how they are able to achieve legitimacy, albeit fragmented, even in the context of scientific uncertainty.

GMO Food Labels Do Not Affect College Student Food Selection, Despite Negative Attitudes towards GMOs.

US Public Law 114–216 dictates that food producers in the United States of America will be required to label foods containing genetically modified organisms (GMOs) starting in 2022; however, there is little empirical evidence demonstrating how U.S. consumers would use food labels that indicate the presence or absence of GMOs. The aim of this two-phase study was to determine how attitudes towards GMOs relate to food choices and how labels indicating the presence or absence of GMOs differentially impact choices among college students—the age group which values transparent food labeling more than any other. Participants (n = 434) made yes/no choices for each of 64 foods. In both phases of the study, participants were randomly assigned to seeing GMO Free labels, contains GMOs labels, or no GMO labels. Across the two phases, 85% of participants reported believing that GMOs were at least somewhat dangerous to health (42% believed GMOs to be dangerous), yet in both studies, although eye-tracking data verified that participants attended to the GMO labels, these labels did not significantly affect food choices. Although college consumers may believe GMOs to be dangerous, their food choices do not reflect this belief.

The Experience of Legal Informing in the Globalized World (Case of US Public Law Libraries)

The Experience of Legal Informing in the Globalized World (Case of US Public Law Libraries)

Иммунитет и деликтная ответственность публично-правовых образований в США

Иммунитет и деликтная ответственность публично-правовых образований в США

Perspectives on U.S. Financial Regulation

The past few years have seen enormous change in US financial market regulation, with the specifics of some of the most radical changes, in the securities area, yet to be decided. This chapter explores US regulation of the insurance, banking, securities and futures trading sectors, and seeks to present this regulation in the broader context of US public law and politics, particularly as these factors affect recent developments.

Forty years of coastal zone management (1975–2014): Evolving theory, policy and practice as reflected in scientific research publications

Since its implementation as public law in the United States in 1972, the theoretical foundation of coastal management has moved forward in diverse directions. Given the time elapsed since the passage of this influential legislation and the growing number of disciplines and scientific papers published on the topic, this work employed bibliometric and social network analysis methods to quantitatively and qualitatively assess coastal management literature published during the period from 1975-2014. The results indicate that coastal management research has increased significantly over time. The emergence of the topic in scholarly work coincides with passage of the Coastal Zone Management Act of 1972 (US Public Law 92–583), and increases in productivity can often be tied to the passage of important legislation or the publication of major policy documents for action on coastal issues. Social network analyses (SNA) indicate loosely connected networks of researchers and institutions, with highly collaborative subgroups that have a significant impact on the field. SNA results also highlight the importance of federal governments and international organizations in driving research and encouraging integrated management. The results indicate that the discipline is evolving to focus more on cross-boundary management strategies, systems perspectives, and consideration of both marine and terrestrial environments.

ClinicalTrials.gov reporting: strategies for success at an academic health center.

The Food and Drug Administration Amendments Act of 2007 (FDAAA 2007, US Public Law 110-98) mandated registration and reporting of results for applicable clinical trials. Meeting these registration and results reporting requirements has proven to be a challenge for the academic research community. Duke Medicine has made compliance with registration and results reporting a high priority. In order to create uniformity across a large institution, a written policy was created describing requirements for clinical trials disclosure. Furthermore, a centralized resource group was formed with three full time staff members. The group not only ensures compliance with FDAAA 2007, it also acts as a resource for study teams providing hands-on support, reporting, training, and ongoing education. Intensive resourcing for results reporting has been crucial for success. Due to implementation of the institutional policy and creation of centralized resources, compliance with FDAAA 2007 has increased dramatically at Duke Medicine for both registration and results reporting. A consistent centralized approach has enabled success in the face of changing agency rules and new legislation.

Constitutional Dialogue between Courts and Legislatures in the European Union: Prospects and Limits

The concept of 'constitutional dialogue' has become a focal point of US and Canadian public law scholarship. This concept sees judicial review not as a check on majority preferences but instead as part of a deliberation between the legislative and judicial branches over how constitutional commitments and general political objectives can be integrated. This article will explore the prospects and limits of developing the dialogue concept in the context of the present-day European Union (EU). The article will present a two-part argument: While the EU's political and legal diversity make the idea of a 'shared responsibility' for constitutional interpretation between judges and policy-makers normatively attractive, the existing institutional structure of the Union limits the incentives necessary for legal and political actors to constitutionally engage.

Parental voices on Individualized Education Programs: ‘Oh, IEP meeting tomorrow? Rum tonight!’

The Individualized Education Program (IEP) was developed as a part of US Public Law 94-142 related to educating students with disabilities. The aim of the IEP process was to ensure that educators and parents are involved in collaboratively creating a formalized plan for instruction that will address unique students’ needs. However, the IEP process has created unintended consequences such as depersonalized meetings, and a focus on paperwork and compliance rather than collaboration with parents. The parents interviewed in this study offered a number of recommendations on how to make both the process and the product of IEP meetings more meaningful.

The new US exit tax scheme: breaking off a long-term relationship with Uncle Sam

The new US exit tax scheme: breaking off a long-term relationship with Uncle Sam

Racial and Ethnic Disparities in End Stage Renal Disease

US Public Law 92-603, signed by President Richard Nixon in 1972, established ESRD as the only medical condition to be covered by Medicare irrespective of age or lack of qualifying disability. Despite the resultant, near universal access to treatment for ESRD, marked differences in the incidence and

Postdetonation nuclear debris for attribution

On the morning of July 16, 1945, the first atomic bomb was exploded in New Mexico on the White Sands Proving Ground. The device was a plutonium implosion device similar to the device that destroyed Nagasaki, Japan, on August 9 of that same year. Recently, with the enactment of US public law 111-140, the "Nuclear Forensics and Attribution Act," scientists in the government and academia have been able, in earnest, to consider what type of forensic-style information may be obtained after a nuclear detonation. To conduct a robust attribution process for an exploded device placed by a nonstate actor, forensic analysis must yield information about not only the nuclear material in the device but about other materials that went into its construction. We have performed an investigation of glassed ground debris from the first nuclear test showing correlations among multiple analytical techniques. Surprisingly, there is strong evidence, obtainable only through microanalysis, that secondary materials used in the device can be identified and positively associated with the nuclear material.

Recommendations for optimization of fortified and blended food aid products from the United States

Fortified blended foods (FBFs) were introduced into the Food for Peace program (also known as US Public Law 480) in the 1960s. Minimal changes have since been made to their formulations. A Food Aid Quality Enhancement Project to assess the nutritional adequacy of FBFs for vulnerable populations was conducted, and the findings indicate that FBFs do not meet the nutritional needs of infants and young children between the ages of 6 and 24 months. Improvements are also needed for FBFs intended for school-aged children and adults. Two separate products would better meet the varying nutritional needs of diverse groups of beneficiaries. Proposed here is a two-step strategy for better addressing the needs of today's food aid beneficiaries: 1) improving FBFs for general distribution to households, schools, and emergency settings, with potential efficiencies gained in manufacturing and formulation to reduce costs; 2) developing new products for infants and young children, which would deliver the nutrient density required for growth and development.

Public Law Litigation: Lessons and Questions

The practice of using courts to foster social change, once confined to the USA, has emerged as a worldwide phenomenon. Foreign practice reflects indigenous forms but faces criticisms similar to that in the USA: that it is ineffective, antidemocratic, and counterproductive. The essay meets these criticisms, first, by recasting US public law litigation as a form of politics that challenges the status quo by forging alliances, changing discursive frames, and disciplining private and public decision making. Looking abroad, the essay emphasizes public law litigation as a meditative institution that facilitates political action and aids in regulatory enforcement where administrative mechanisms are weak or regulation requires ongoing elaboration. Finally, the essay suggests that criticisms of public law litigation tend to neglect three factors: the actual and not assumed comparative advantages of different institutional actors, the role of temporal conditions in affecting social change, and the ubiquity of complex, not dichotomous, relations.

Hawaiian Issues

On 17 January 1893, the monarchy of Hawai'i was deposed by a group who "represented the American and European sugar planters, descendents of missionaries and financiers" (US Public Law 103-150). With the aid [End Page 179] of the United States minister, John L Stevens, and US military forces, they were able to deliver Hawai'i into the hands of the US federal government. In a case of historical déjà vu, it seems the same adversaries from a century ago have now been reincarnated and are attacking what is left of native rights in Hawai'i.

Health conditions before Columbus: paleopathology of native North Americans.

Information about the health status of the earliest inhabitants of North America provides a chronology of health problems that spans more than a thousand years. Studies of disease in ancient times add an important dimension to our understanding of the life struggles of a largely unknown past. In this article, we provide a brief overview of health conditions and quality of life in North America before contact and colonization. Data on health in ancient societies are inferred from the analysis of a wide range of archaeologic materials, but human bones and teeth form by far the largest body of evidence. For several regions in the United States, there are health chronologies spanning hundreds of years. For example, Walker, using a multimethod approach involving the analysis of skeletal lesions and detailed reconstruction of the environment, demonstrated that Indians of southern California who lived in marginal island environments (about 800 BC to AD 1150) showed greater evidence of health problems than those who lived on the mainland, where food was more abundant and diverse.1 He also showed increased rates of infectious diseases over time. There has been a shift toward conducting population-level analyses that shed light on epidemiologic characteristics of the health of ancient societies by providing frequencies and patterning of disease within and between populations.2 Much of the recent paleopathology literature emphasizes temporal and spatial variability in patterns of disease and the shift in many parts of North America at different times from an economy based on gathering and hunting to agriculture. Although not all groups in North America adopted full-blown maize agriculture, many did, and it has been the focus of intense debate.2 The study of North American archaeologic remains has been under protest by native groups because historically they have had little say over the excavation and curatorship of their ancestors' remains.3 These protests led to legislation passed in 1990 entitled the Native American Graves Protection and Repatriation Act (US Public Law 101-601). This law ensures that Native Americans have the final say regarding the nature of studies that rely on ancestral and historic human remains. In many ways, this legislation has redefined the nature of archaeologic research in the United States and has opened new venues of study as Native Americans and anthropologists have begun working together to reconstruct the past.4

Update of Comparative Occurrence Rates for Offshore Oil Spills

Estimates of occurrence rates for offshore oil spills are useful for analyzing potential oil-spill impacts and for oil-spill response contingency planning. With the implementation of the Oil Pollution Act of 1990 (US Public Law 101-380, August 18, 1990), estimates of oil-spill occurrence became even more important to natural resource trustees and to responsible parties involved in oil and gas activities. Oil-spill occurrence rate estimates have been revised based on US Outer Continental Shelf (US OCS) platform and pipeline spill data (1964 through 1999), worldwide tanker spill data (1974 through 1999), and barge spill data for US waters (1974–1999). These spill rates are expressed and normalized in terms of number of spills per volume of crude oil handled. All estimates of spill occurrence rates were restricted to spills greater than or equal to 1000 barrels (159 m 3, 159 kl, 136 metric tonnes, 42,000 US gallons). The revisions compared to the previously published rates calculated through 1992 ( Anderson and LaBelle, 1994) indicate that estimates for the US OCS platform spill occurrence rates continue to decline, primarily because no spills have occurred since 1980. The US OCS pipeline spill occurrence rates for spills greater than or equal to 1000 barrels remained essentially unchanged. However, the rate for larger OCS pipeline spills (greater than or equal to 10,000 barrels) has decreased significantly. Worldwide tanker spill rates, rates for tanker spills in US waters, and rates for barge spills in US waters decreased significantly. The most recent 15-year estimates for 1985–1999 (compared to rates for the entire data series) showed that rates for US OCS platforms, tankers, and barges continued to decline.

Reimbursement for Medical Foods for Inborn Errors of Metabolism

Inborn errors of amino acid metabolism such as phenylketonuria, maternal phenylketonuria, maple syrup urine disease, homocystinuria, methylmalonic acidemia, propionic acidemia, isovaleric acidemia and other disorders of leucine metabolism, glutaric acidemia type I and tyrosinemia types I and II, and urea cycle disorders are rare diseases that are treatable by diet. Treatment might include the restriction of one or more amino acids, the restriction of total nitrogen, or the supplementation of specific substances. Untreated, these diseases culminate in severe mental retardation or death. Once diagnosis is confirmed, treatment of amino acid and urea cycle disorders must be carefully monitored by a physician with expertise in metabolic diseases. Special medical foods, commercially available, are indispensable for the active, ongoing treatment of diagnosed amino acid and urea cycle disorders. Special medical foods would, if used as the sole dietary source, represent a hazard to affected and healthy children. US Public Law (Publ L) 100-290 defines the term medical food as ". . . a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."1 After passage of Publ L 100-290, many states provided funding for these products through Medicaid, and most states offered assistance through Crippled Children's and Women, Infant, and Children's programs. Some states now have laws mandating private insurance coverage for special medical foods. It is the position of the American Academy of Pediatrics that special medical foods that are used in the treatment of amino acid and urea cycle disorders are medical expenses that should be reimbursed.