Larisa Rudenko - Academia.edu (original) (raw)

Papers by Larisa Rudenko

Reproduction in Domestic Animals, 2012

Animal biotechnology represents one subset of tools among a larger set of technologies for potent... more Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA's conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk-based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA's role in evaluation of animal cloning and GE animals.

Principles of Cloning, 2014

Animal cloning is used to propagate desirable genetics, facilitate more efficient movement of ani... more Animal cloning is used to propagate desirable genetics, facilitate more efficient movement of animal genetics, and rescue valuable or endangered genetics. To address safety concerns about cloning, the US Food and Drug Administration (FDA) conducted a risk assessment that addressed food safety and animal health of animal clones and their progeny. The FDA found that there were no unique animal health risks compared with other assisted reproductive technologies (although those present were seen at higher frequencies), food from animal clones was as safe to eat as food from animals produced using conventional practices, the progeny of clones are not clones, and regulation of animal clones and their progeny in the USA should not differ from that of conventionally produced animals. Although views on whether animal clones and their progeny may be subject to additional regulation varies across international jurisdictions, the scientific findings of the FDA’s cloning risk assessment are consistent with findings of risk assessments performed by other international entities.

Xenotransplantation, 2010

The use of xenogeneic porcine pancreatic islets has been shown to be a potentially promising alte... more The use of xenogeneic porcine pancreatic islets has been shown to be a potentially promising alternative to using human allogeneic islets to treat insulin-dependent type 1 diabetes (T1D). This article provides an overview of the existing FDA regulatory framework that would be applied to the regulation of clinical trials utilizing xenogeneic porcine pancreatic islets to treat T1D.

Theriogenology, 2007

The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary requ... more The Food and Drug Administration's (FDA's) Center for Veterinary Medicine issued a voluntary request to producers of livestock clones not to introduce food from clones or their progeny into commerce until the agency had assessed whether production of cattle, swine, sheep, or goats by somatic cell nuclear transfer (SCNT) posed any unique risks to the animal(s) involved in the process, humans, or other animals by consuming food from those animals, compared with any other assisted reproductive technology (ART) currently in use. Following a comprehensive review, no anomalies were observed in animals produced by cloning that have not also been observed in animals produced by other ARTs and natural mating. Further systematic review on the health of, and composition of meat and milk from, cattle, swine, and goat clones and the progeny of cattle and sheep did not result in the identification of any food-consumption hazards. The agency therefore concluded that food from cattle, swine, and goat clones was as safe to eat as food from animals of those species derived by conventional means. The agency also concluded that food from the progeny of the clone of any species normally consumed for food is as safe to eat as those animals. The article also describes the methodology used by the agency to analyze data and draw these conclusions, the plans the agency has proposed to manage any identified risks, and the risk communication approaches the agency has used.

Nature Biotechnology, 2007

The evidence gathered thus far--ultimately to be published in the Draft Risk Assessment on Animal... more The evidence gathered thus far--ultimately to be published in the Draft Risk Assessment on Animal Cloning--indicates that there are no unique risks associated with animal cloning.

Journal of Toxicology and Environmental Health, Part B, 2007

Copper (Cu) and its alloys are used extensively in domestic and industrial applications. Cu is al... more Copper (Cu) and its alloys are used extensively in domestic and industrial applications. Cu is also an essential element in mammalian nutrition. Since both copper deficiency and copper excess produce adverse health effects, the dose-response curve is U-shaped, although the precise form has not yet been well characterized. Many animal and human studies were conducted on copper to provide a rich database from which data suitable for modeling the dose-response relationship for copper may be extracted. Possible dose-response modeling strategies are considered in this review, including those based on the benchmark dose and categorical regression. The usefulness of biologically based dose-response modeling techniques in understanding copper toxicity was difficult to assess at this time since the mechanisms underlying copper-induced toxicity have yet to be fully elucidated. A dose-response modeling strategy for copper toxicity was proposed associated with both deficiency and excess. This modeling strategy was applied to multiple studies of copper-induced toxicity, standardized with respect to severity of adverse health outcomes and selected on the basis of criteria reflecting the quality and relevance of individual studies. The use of a comprehensive database on copper-induced toxicity is essential for dose-response modeling since there is insufficient information in any single study to adequately characterize copper dose-response relationships. The dose-response modeling strategy envisioned here is designed to determine whether the existing toxicity data for copper excess or deficiency may be effectively utilized in defining the limits of the homeostatic range in humans and other species. By considering alternative techniques for determining a point of departure and low-dose extrapolation (including categorical regression, the benchmark dose, and identification of observed no-effect levels) this strategy will identify which techniques are most suitable for this purpose. This analysis also serves to identify areas in which additional data are needed to better define the characteristics of dose-response relationships for copper-induced toxicity in relation to excess or deficiency. Copper occurs in nature in its metallic form and in ores and minerals, and was one of the first metals used by humans. The use of copper has been traced back to approximately 5000 BC in the Aegean region, where it was employed for creating valuable art objects. Cyprus, which draws its name from the Latin word cuprum, was a major source of copper, as were regions in Anatolia and Spain. Copper mixed with tin in a 9:1 ratio comprises bronze, and the ability to The authors are grateful to the referees and the editor for their constructive comments on this article. We also thank Nicole Boom for her careful reading of the final draft and Nagaraj Yenugadhati for his editorial assistance.

Journal of Toxicology and Environmental Health, Part A, 2010

While its precise form has not yet been defined, it is assumed that the exposure-response curve f... more While its precise form has not yet been defined, it is assumed that the exposure-response curve for copper (Cu) is U-shaped, as both Cu deficiency and excess can produce adverse health effects. Exposure-response relationships provide the foundation for setting recommended levels of exposure to essential and nonessential substances. A group of toxicologists, biologists, and epidemiologists formed a working group in 2002 to review the literature on Cu excess and deficiency as well as possible exposure-response modeling strategies. It was decided that in order to conduct more complex modeling exercises with studies on Cu, the information had to be organized into a database for application of emerging analytical approaches in exposure-response assessment. The database would support both current as well as proposed methods for exposure-response assessment and accommodate a variety of reporting methods found in the literature. As there are multiple studies looking at a wide range of adverse health effects attributed to excess and deficiency, data were organized into ordered categories of severity to create a common measure of response. The present study (1) outlines the approach used to identify studies for the Cu database based on their quality and usefulness for exposure-response analyses; (2) provides an overview of the process used to define a common dose metric; and (3) describes the process used to categorize a diverse number of responses from Cu excess and deficiency to an ordinal severity score. Efforts are underway to use this database to define the exposure-response curve for Cu excess and deficiency; however, the comprehensive database can be used to carry out other in-depth analyses on Cu toxicity.

The objective of this study was to evaluate the mortality and cancer incidence experience of pers... more The objective of this study was to evaluate the mortality and cancer incidence experience of persons employed in the chemical industry in the United States and Western Europe, as reported in the peer- reviewed literature between 1966 to 1997 (>1 million workers and >15 million person-years). Observed and expected numbers of cases for each of 35 mortality and 23 cancer incidence endpoints were abstracted from cohort studies (n=461) and grouped (n= 185) so that specific populations could be traced from the earliest to the most recently published report. Standardized mortality ratios (SMRs) or standardized incidence ratios (SIRs) and 95% confidence intervals were abstracted/generated, and meta-analyses were undertaken for the entire cohort as well as sub- cohorts (e.g., gender, latency, or duration of employment). Fewer than expected deaths from all causes, cardiovascular disease, noncancer respiratory disease, cirrhosis of the liver, and external causes were observed, some or al...

Epidemiology, 2001

We evaluated the mortality and cancer experience of employees of the chemical industry in the Uni... more We evaluated the mortality and cancer experience of employees of the chemical industry in the United States and western Europe, as reported in the peer-reviewed literature between 1966 and 1997 (Ͼ1 million workers and Ͼ15 million personyears). Cohort studies (N ϭ 461) were grouped (N ϭ 181) so that specific populations could be traced from the earliest to the most recently published report, and we extracted observed and expected numbers of cases for each of 35 mortality and 23 cancer incidence endpoints. We then generated standardized mortality ratios or standardized incidence ratios and 95% confidence intervals, and undertook meta-analyses of subcohorts (for example, gender, latency, or duration of employment), as well as the entire cohort. With few exceptions, the observed cause-specific mortality and site-specific cancer incidences were reassuring: overall, 10% fewer deaths were observed than expected. Fewer than expected deaths from all causes, cardiovascular disease, noncancer respiratory disease, cirrhosis of the liver, and external causes were observed, some or all of which may be attributed to a "healthy worker effect." Meta-analyses revealed weak to moderate excesses of lung and bladder cancers likely caused by occupational exposure to known human carcinogens. We also observed a 10-15% increase in lymphatic and hematopoietic cancers. Additional research is required to gain a more complete understanding of the potential role that methodology and environmental or occupational influences may play in these associations.