Federal Regulations Research Articles

Money and cooperative federalism: evidence from EPA civil litigation

Abstract The federalism structure of the US government requires active cooperation from state governments to successfully enforce federal environmental regulations. What explains the variation in state governments’ participation in lawsuits against firms that are accused of violating major environmental statutes? We argue that firms’ political connections with state politicians affect a state government’s decision to join the litigation process. By constructing a novel dataset on the EPA’s civil cases and settlements for the period 1998–2021, we show that state environmental agencies are less likely to join the EPA in court when the defendant firms contributed to Republican state legislators. We do not find the same pattern when firms have connections with Democratic legislators. We present various mechanisms of how state politicians influence behaviors of state bureaucrats. Our findings highlight how state politics can be an avenue for firms to exert influence on federal environmental regulations.

Produção artesanal de alimentos lácteos em Goiás: análise de normativas e cenário do Selo Arte

Introduction: The State of Goiás has significant food production from family rural agro-industries. Objective: Considering this scenario and the recent publication of legislation on the crafting of foods of animal origin, the objective of this article was to broaden the debate on the topic through a historical-critical analysis of the federal and state regulations in Goiás, as well as to characterize the enterprises that were granted Selo Arte in the state. Method: Documentary research was carried out in order to identify the current legislation, and field research was conducted using a questionnaire that was applied to all five producers who acquired Selo Arte in Goiás. Results: As a result, it was observed that there are many gaps and bottlenecks in the legislation related to artisanal products, which hinder the formal commercialization of artisanal products and the regularization of rural agro-industries. As for the Goiás enterprises that have the Selo Arte, despite having some similarities, it was not possible to identify a characteristic pattern, most likely because the legislation is recent and few establishments have obtained the concession, which does not generate a significant quantity for comparisons. Conclusions: In conclusion, it was observed that it is essential to improve legislation at the federal, state, and municipal levels with a view to encouraging the legalization of food processing from rural agro-industries, especially family-owned ones.

Traffic Projections in Noise Analysis

Traffic volumes are an integral part of any highway traffic noise analysis. The defining procedure for federal regulation for highway transportation noise analysis is 23 CFR 772. Section 23 CFR 772.9 Traffic Noise Prediction (d) states "In predicting noise levels and assessing noise impacts, traffic characteristics that would yield the worst traffic noise impact for the design year shall be used." States have the discretion to determine how to interpret what traffic metrics they use in their federally approved noise analyses. For example, some states use Level of Service (LOS) traffic volumes, while others use peak hour or design hour volume. Some states use an in-depth method to determine loudest hour which incorporates traffic volumes for a twenty four hour period and their corresponding operating speed per hour. This paper will discuss the time and effort associated with each procedure. Case studies will be presented to determine which of these traffic metrics best matches the current traffic counts.

Aviation Noise in the United States: The FAA's Civil Aviation Noise Policy Review

The FAA has long recognized that aircraft noise is a primary and pivotal concern of many stakeholders. Through input received via a Federal Register notice on its noise research portfolio, FAA was encouraged by stakeholders to revise its policy in light of its research findings. In response to this feedback, the FAA initiated a review of the foundational elements of its Noise Policy (noise metrics and noise thresholds), which aims address four key considerations: how the FAA analyzes, explains, and publicly presents changes in noise exposure from aviation activity, how changes to the civil aviation noise policy may better inform agency decision-making, the types of impacts it considers in making decisions, and potential improvements to how the FAA analyzes, explains, and presents changes in exposure to civil aviation noise. This paper will present an overview of the FAA's rationale for and approach to the noise policy review. The paper will conclude with a discussion of the next steps FAA expects to take in the review process.

Airport perspectives - FAA Noise Policy Review

The FAA has funded a great deal of research related to the impacts of aviation noise on communities, which has led to the FAA undertaking a review of the Civil Aviation Noise Policy. However, before FAA determines any changes in noise policy, additional research is needed. Our paper discusses the work that ACI-NA - in the role of representing local, regional and state governing bodies that own and operate commercial airports in the United States and Canada - has undertaken, and the areas for further research that we identified in the ACI-NA comment letter submitted to the Federal Register in September 2023 in response to the Federal Aviation Administration's (FAA) Review of the Civil Aviation Noise Policy, (Docket ID No. FAA-2023-0855, 86 Fed. Reg. 26641 (May 1, 2023)). Our paper will discuss our comments, which include policy considerations, as well as specific areas that we recommend for future research, such as additional precision in the causes of annoyance from aviation noise, and why we think that additional research is needed.

Open Access: Opening or Closing Doors for Junior Faculty?

The Open Access movement has transformed the landscape of medical publishing. Federal regulations regarding Open Access have expanded in the USA, and journals have adapted by offering a variety of Open Access models that range widely in cost and accessibility. For junior faculty with little to no funding, navigating this ever-changing landscape while simultaneously balancing the pressures of publication and promotion may present a particular challenge. Open Access provides the opportunity to amplify the reach and impact of scientific research, yet it often comes at a cost that may not be universally affordable. In this perspective, we discuss the impact of Open Access through the lens of junior faculty in general internal medicine. We describe the potential benefits and pitfalls of Open Access on junior faculty with a focus on research dissemination and cost. Finally, we propose sustainable solutions at the individual and systems-level to help navigate the world of Open Access to promote career growth and development.

Optimizing early phase clinical trial washout periods: a report from the therapeutic advances in childhood leukemia and lymphoma (TACL) consortium.

The National Cancer Institute (NCI) issued a 2021 memorandum adopting the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) task force recommendations to broaden clinical study eligibility criteria. They recommended that washout periods be eliminated for most prior cancer therapy and when required, to utilize evidence/rationale-based criteria. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium responded to this guidance. A TACL task force reviewed the consortium's research portfolio, the relevant literature and guidance documents from ASCO-Friends, NCI, and US Food and Drug Administration (FDA) to make expert consensus and evidence-based recommendations for modernizing, broadening and codifying TACL-study washout periods while ensuring consistency with pediatric ethics and federal regulations. TACL's screening log was reviewed to estimate the impact that updated washout periods would have on patient inclusivity and recruitment. Over a 19-year period, 42 patients (14.6% of all screened ineligible (n = 287) patients), were identified as excluded from TACL early-phase studies exclusively due to not meeting washout criteria. An additional six (2.1%) did not meet washout and at least one other exclusion criterion. A new TACL washout guidance document was developed/adopted for use. Where washout criteria were not eliminated, rationale/evidenced-based criteria were established with citation. In an effort to reduce unnecessary exclusion from clinical trials, TACL created rationale/evidenced-based washout period standards largely following guidance from the NCI/ASCO-Friends recommendations. These new, expanded eligibility criteria are expected to increase access to TACL clinical trials while maintaining safety and scientific excellence.

Show Your Hand: The Impacts of Fair Pricing Requirements in Procurement Contracting

ABSTRACTThis paper studies how a federal procurement regulation, known as the Truth in Negotiations Act (TINA), affects the competitiveness and execution of government contracts. TINA stipulates how contracting officials (COs) can ensure reasonable prices. Following TINA, for contracts above a certain size threshold, COs can no longer rely solely on their own judgment that a price is reasonable. Instead, they must either require suppliers to provide accounting data supporting their proposed prices or expect multiple bids. Using a regression discontinuity design, I find that above‐threshold contracts experience greater competition (i.e., more bids), improved performance (i.e., less frequent renegotiations and cost overruns), and reduced use of the harder‐to‐monitor cost‐plus pricing, compared to below‐threshold contracts. These findings suggest that TINA's requirements enhance competition and oversight for above‐threshold contracts.

Effect of different types of pectin on the physicochemical, rheology, and sensory properties of low-fat yogurt

Abstract Low-fat yogurt has been defined to contain fat content of not more than 2.0 percent as per The Code of Federal Regulations, FDA, U.S. Nevertheless, the reduced fat content affects the physicochemical properties of yogurt by weakened texture, poor body, syneresis, and sensory quality. This is due to fat globules that govern the protein linkages that are responsible for the yogurt’s texture and firmness. The objectives of this study are to evaluate the physicochemical, rheology properties, and to determine the sensory properties and overall acceptability of low-fat yogurt enriched with different types of pectin. Pectin helps improve the gel characteristics, rheology, and microstructure of set yogurt through interactions with the casein network. Two different types of pectins are used which are low-methoxyl pectin (LMP) and high-methoxyl pectin (HMP). For each type, two different concentrations were used which are 0.5% and 1.0% for both types of pectin. Analysis such as pH measurement, titrable acidity, color measurement, water holding capacity measurement, syneresis measurement, viscosity measurement, microbial analysis, and scanning electron microscopy were conducted. The results from the analysis above were subjected to two-way ANOVA and post hoc Tukey’s test. The addition of LMP (0.5% and 1.0%) showed a positive effect on the quality of yogurt with primary attributes compared to the pectin added with HMP and control sample. In conclusion, the low-fat yogurt had a positive effect due to the enrichment of the pectin. Sample 4 which is the low-fat yogurt with 1.0% of LMP showed better properties compared to other samples.

Assessing Injury Rates to Red-tailed Hawks Live-captured Using Three Common Methods

Abstract Assessments of the impact of live-capture methods and tools are important to wildlife research and management efforts. Federal regulations (e.g., the Migratory Bird Treaty Act and the Animal Welfare Act) require humane and ethical treatment of migratory birds. Therefore, it is important to conduct live-trapping using methodologies that minimize the potential for injury or mortality. We evaluated the injury rate experienced by red-tailed hawks Buteo jamaicensis captured using three, commonly-used live-traps (i.e., bal-chatri trap, Swedish goshawk trap, and pole trap). Professional wildlife biologists at airports in Illinois live-captured 25 free-ranging red-tailed hawks using bal-chatri traps, 42 red-tailed hawks using Swedish goshawk traps, and 25 red-tailed hawks using pole traps. Of the red-tailed hawks (n = 53) identified by a veterinary forensic pathologist as having one or more capture-related injuries, 85% of the injuries were classified as ‘minor’ (e.g., cuts or scrapes), 13% were classified as ‘moderate’ (e.g., hemorrhaging), and only 2% were classified as ‘severe’ (e.g., fractures). When considering only injuries classified as ‘moderate’ and ‘severe’, we found no difference (χ21 = 0.38, P = 0.54) in the frequency of these injuries among the three trap types. The three live-trap devices we evaluated can be efficient tools that result in minimal risk of injury or death when used by those with proper training and experience to live-capture red-tailed hawks for research purposes, while conducting raptor hazard management activities, or licensed falconers acquiring wild red-tailed hawks.

Prevalence of menu label use and its association with calorie intake among US adults

The 2018 Federal Menu Labeling regulations require restaurants and similar retail food establishments that are part of a chain with 20 or more locations to provide calorie and other nutrition information for standard menu items. In this study, we describe the sociodemographic correlates of prevalence of menu label use at Food-Away-From-Home (FAFH) establishments and estimate the association between menu label use and calorie intake. We use nationally representative data spanning the years 2007–2018 and multivariable logit regression and ordinary least squares regression models. For FAFH establishments, we find that female respondents have about 26% (95% CI = [1.14, 1.39]) higher odds of using menu labels. Respondents with high school degree have 51 percent higher odds (95% CI = [1.24, 1.85]), respondents with some college education have 107 percent higher odds (95% CI = [1.74, 2.47]) of seeing menu labels. Higher income is associated with 12% (95% CI = [1.08, 1.15]) greater odds of seeing menu labels. Hispanic respondents have 29% (95% CI = [0.62, 0.81]) lower odds of seeing and 79% (95% CI = [1.41, 2.29]) higher odds of using menu labels. Black respondents have 54% (95% CI = [1.35,1.75] higher odds of seeing menu labels at sit-down restaurants. Menu label users at fast-food restaurants reported consuming 202 kcal (95% CI = [-252,-153]) fewer total calories than nonusers and menu label users at sit-down restaurants reported using 181 kcal (95% CI = [-256,-106]) fewer total calories than nonusers. Our findings highlight the sociodemographic disparities in menu label use and provide baseline estimates for future studies evaluating the federal menu labeling regulation.

American Heart Association Cardiogenic Shock Registry: Design and Implementation.

Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industry, the American Heart Association volunteers and staff have launched a quality improvement registry to better understand the clinical manifestations of shock phenotypes, and to benchmark the management patterns, and outcomes of patients presenting with cardiogenic shock to hospitals across the United States. Participating hospitals will enroll consecutive hospitalized patients with cardiogenic shock, regardless of etiology or severity. Data are collected through individual reviews of medical records of sequential adult patients with cardiogenic shock. The electronic case record form was collaboratively designed with a core minimum data structure and aligned with Shock Academic Research Consortium definitions. This registry will allow participating health systems to evaluate patient-level data including diagnostic approaches, therapeutics, use of advanced monitoring and circulatory support, processes of care, complications, and in-hospital survival. Participating sites can leverage these data for onsite monitoring of outcomes and benchmarking versus other institutions. The registry was concomitantly designed to provide a high-quality longitudinal research infrastructure for pragmatic randomized trials as well as translational, clinical, and implementation research. An aggregate deidentified data set will be made available to the research community on the American Heart Association's Precision Medicine Platform. On March 31, 2022, the American Heart Association Cardiogenic Shock Registry received its first clinical records. At the time of this submission, 100 centers are participating. The American Heart Association Cardiogenic Shock Registry will serve as a resource using consistent data structure and definitions for the medical and research community to accelerate scientific advancement through shared learning and research resulting in improved quality of care and outcomes of shock patients.

United States Navy nuclear accident dosimetry program: History and Current Status

Federal Regulations of the United States require that installations possessing sufficient quantities of fissile material to potentially constitute a critical mass, such that the excessive exposure of individuals to radiation from a nuclear accident is possible, shall provide appropriate nuclear accident dosimetry. The American National Standard ANSl/HPS N13.3–2013 Dosimetry for Criticality Accidents provides technical, quality assurance, and performance requirements for nuclear accident dosimeters (NAD). In 2023 the U.S. Navy operated 82 nuclear-powered ships, with the fleet being composed of 11 aircraft carriers, 68 submarines, having a total number of 98 reactors. Since 1968 the U.S. Navy has used fixed nuclear accident dosimeters (FNAD) mounted to the bulkheads surrounding naval nuclear propulsion reactors. Since 1968 the US Navy has used two nuclear accident criticality dosimeters. The first Navy accident dosimeter DT-518/PD was introduced in 1968. It was developed by the Naval Radiological Defense Laboratory in San Francisco, California under leadership of Eugene Tochilin. This dosimeter contains two indium foils for quick dose assessments using shipboard gamma instruments available on nuclear powered vessels and two sulfur pellets/LiF TLD-700 powder for final dose determination at the Naval Dosimetry Center. The newest Navy NAD is the DT-723/PD, which contains indium foil, gold foil, cadmium shielded gold foil, sulfur pellet and a LiF TLD-700 chip. This paper provides a brief description of the measurement procedures, results of the testing of both NADs and comparison of their performance.

Measures to Counter Cruelty to Animals: Issues of an Inter-Sectoral Approach

Until recently, liability for cruelty to animals was provided for in Art. 245 of the Criminal Code of the Russian Federation. Administrative and legal measures for it were established in a number of constituent entities of the Russian Federation. The establishment of federal regulations governing the responsible treatment of animals has necessitated the establishment of these measures at the federal level. The problem was partly resolved in 2023 as a result of the addition of administrative legislation with rules establishing liability, including for the above acts. This article is devoted to the assessment of these norms, in connection with criminal law norms, with an emphasis on some problematic provisions that can cause difficulties at the level of law enforcement practice. They relate, in particular, to the subject of offenses, the content of the act, their subject, and the subjective side.

Numerical Simulations of Passive Heat Removal from Mobile Microreactors

As nuclear energy becomes increasingly vital to the goals of carbon neutrality by 2050, nuclear microreactors are being researched as an option for easily transportable energy. Designed to be transportable, factory fabricated, and self-adjusting, nuclear microreactors will fill in the gaps to help make the U.S. power grid more robust. Before designs can proceed, studies must be conducted on the safety of transporting these mobile microreactors while confined within a standard International Organization for Standardization (ISO) shipping container. Because of their mobile nature, microreactors will not have access to many of the engineered decay heat removal methods that traditional reactors utilize during shutdown. Current regulations state that the surface temperature of the microreactor needs to remain below 85°C while being transported on highways. This work investigates the surface temperature profiles of a mobile microreactor while confined within an ISO shipping container that does not allow forced convection to cool the outer reactor wall. Investigations have been performed for several configurations, including different reactor sizes, power levels, and scenarios with or without shielding around the reactor pressure vessel. This conservative safety analysis restricts the power level of the reactor to be less than 1 MW(electric). A more realistic analysis with the intermittent shutdown of shipping container air circulation demonstrates that a 4-MW(electric) reactor will reach 85°C per the Code of Federal Regulations limitations after 1 h.

Quitting smoking with…smoke? Unauthorized claims used by herbal cigarette manufacturers.

Herbal cigarettes are made with non-tobacco plant materials (e.g., tea leaves, hemp), are typically sold pre-rolled in packs and with filters, and are combusted and smoked like tobacco cigarettes. Herbal cigarette manufacturers have a history of making misleading health claims and at least one company has previously settled with the US Federal Trade Commission over deceptive advertising. This study examined current claims and product characteristics of herbal cigarettes sold by a popular online retailer. We searched Amazon.com for "herbal cigarettes" and "hemp cigarettes" and identified all herbal cigarette products sold on the first page of search results (n=51). Two coders independently content analyzed each product's Amazon page for claims (e.g., smoking cessation, health), product characteristics (e.g., flavors), and presence of disclaimers and warnings. Overall, 78.4% of product pages made smoking cessation claims (e.g., "A more scientific way to quit smoking", "…decreases nicotine craving symptom and helps to quit tobacco smoking"). Further, 45.1% of product pages included claims describing lower risk/exposure compared to tobacco products (e.g., "…without the addictive nicotine and toxic chemicals found in tobacco cigarettes"). Some herbal products were available in multiple flavors, including menthol (21.6%) and fruit (17.7%). Only 35.3% of products included visible health warnings on product packaging. Many herbal cigarette products sold on Amazon.com make unauthorized cessation and health claims. Regulatory agencies must act decisively to stop the misleading advertising of these products and develop appropriate warnings to educate the public about the potential harms of herbal cigarettes. This content analysis documents the use of unauthorized and misleading claims made in the marketing of herbal cigarettes.These findings highlight the need for enforcement of existing federal regulations, which prohibit deceptive advertising.Research is needed to inform the development of appropriate warning labels that can be used to inform consumers of the potential harms of smoking herbal cigarettes.

A Novel Use of the "3-Day Rule": Post-discharge Methadone Dosing in the Emergency Department.

Methadone is a medically necessary and lifesaving medication for many patients with opioid use disorder. To adequately address these patients' needs, methadone should be offered in the hospital, but barriers exist that limit its continuation upon discharge. The code of federal regulations allows for methadone dosing as an inpatient as well as outpatient dispensing for up to three days to facilitate linkage to treatment. As a quality initiative, we created a new workflow for discharging patients on methadone to return to the emergency department (ED) for uninterrupted dosing. Our addiction medicine team changed hospital methadone policy to better allow hospitalization as a window of opportunity to start methadone. This necessitated the creation of a warm-handoff process to link patients to methadone clinics if that linkage could not happen immediately on discharge. Thus, our team created the "ED Bridge" process, which uses the "3-day rule" to dispense methadone from the ED post hospital discharge. We then followed every patient we directed through this workflow as an observational cohort for outcomes and trends. Of the patients for whom ED bridge dosing was planned, 40.4% completed all bridge dosing and an additional 17.3% received at least one but not all bridge doses. Established methadone patients made up 38.1% of successful linkages, and 61.9% were patients who were newly started on methadone in the hospital. Improving methadone as a treatment option remains an ongoing issue for policymakers and advocates. Our ED bridge workflow allows us to expand access and continuation of methadone now using existing laws and regulations, and to better use hospitals as a point of entry into methadone treatment.

Creating Culturally Adapted Multilingual Materials for Research

Patients who speak languages other than English are frequently excluded from research. This exclusion exacerbates inequities, biases results, and may violate federal regulations and research ethics. Language justice is the right to communicate in an individual’s preferred language to address power imbalances and promote equity. To promote language justice in research, we propose a method to translate and culturally-adapt multifaceted research materials into multiple languages simultaneously. Our method involves a multistep approach, including professional translation, review by bilingual expert panels to refine and reach consensus, and piloting or cognitive interviews with patients and families. Key differences from other translation approaches (eg, the World Health Organization) include omitting back-translation, given its limited utility in identifying translation challenges, and limiting expert panelist and piloting-participant numbers for feasibility. We detail a step-by-step approach to operationalizing this method and outline key considerations learned after utilizing this method to translate materials into 8 languages other than English for an ongoing multicenter pediatric research study on family safety-reporting. Materials included family brochures, surveys, and intervention materials. This approach took ∼6 months overall at a cost of <$2000 per language (not including study personnel costs). Key themes across the project included (1) tailor scope to timeline, budget, and resources, (2) thoughtfully design English source materials, (3) identify and apply guiding principles throughout the translation and editing process, and (4) carefully review content and formatting to account for nuances across multiple languages. This method balances feasibility and rigor in translating participant-facing materials into multiple languages simultaneously, advancing language justice in research.

A Products Liability Framework for AI

A products liability framework, drawing inspiration from the regulation of FDA-approved medical products—which includes federal regulation as well as products liability—holds great promise for tackling many of the challenges AI poses. Notwithstanding the new challenges that sophisticated AI technologies pose, products liability provides a conceptual framework capable of responding to the learning and iterative aspects of these technologies. Moreover, this framework provides a robust model of the feedback loop between tort liability and regulation.The regulation of medical products provides an instructive point of departure. The FDA has recognized the need to revise its traditional paradigm for medical device regulation to fit adaptive AI/ML technologies, which enable continuous improvements and modifications to devices based on information gathered during use. AI/ML technologies should hasten an even more significant regulatory paradigm shift at the FDA away from a model that puts most of its emphasis on (and resources into) ex ante premarket approval to one that highlights ongoing postmarket surveillance. As such a model takes form, products liability should continue to play a significant information-production and deterrence role, especially during the transition period before a new ex post regulatory framework is established.

Use of patent term extensions to restore regulatory time for medical devices in the United States

ABSTRACT Background Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear. Research Design and Methods We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office. Results Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average. Conclusions The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.