Law and Regulations Exam Review
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Questions and Answers

What was the primary catalyst for the creation of the Cruelty to Animals Act?

  • The growing demand for animals in surgery practice.
  • The increasing need to save and prolong animal health.
  • The Federal Food, Drug, and Cosmetic Act regulations
  • The anti-vivisectionist movement's protest against the use of animals for entertainment. (correct)

How did the Federal Food, Drug, and Cosmetic Act impact animal experimentation practices?

  • It required animal testing to prove the safety of all new cosmetics, which caused a sharp increase in animal testing.
  • It led to a decrease in animal testing due to strict oversight and punishment for non-compliance.
  • It included requirements for drug and device safety to be proven in animals before being released to the public, increasing medical testing on animals. (correct)
  • It mandated that all animal testing facilities adhere to the Animal Welfare Act standards.

Why is the Animal Welfare Act (AWA) considered a foundational law in the context of animal regulations?

  • It imposes strict penalties for non-compliance.
  • It serves as the absolute standard for frequency of inspections.
  • It explicitly prohibits animal testing under any circumstance.
  • It establishes the minimum acceptable standards for animal care, to which other laws, policies, and guidelines refer. (correct)

The discovery and use of HeLa cells raised ethical concerns because:

<p>The cells were taken and utilized without Henrietta Lacks' consent or compensation to her family. (A)</p> Signup and view all the answers

Which of the following practices is permissible under the Cruelty to Animals Act?

<p>Experimentation on animals is allowed only for teaching purposes or to save/prolong human health, and the animals must be anesthetized. (B)</p> Signup and view all the answers

What event most directly influenced the passage of the Animal Welfare Act?

<p>Reports of stolen pets being sold to research facilities and kept in poor conditions, referred to as concentration camps for dogs. (B)</p> Signup and view all the answers

What role does the Animal and Plant Health Inspection Service (APHIS) play in enforcing the Animal Welfare Act (AWA)?

<p>It conducts unannounced inspections of facilities to ensure compliance with the AWA and can issue fines for violations. (B)</p> Signup and view all the answers

Which of the following scenarios represents a violation of the Animal Welfare Act (AWA)?

<p>A breeding facility keeps animals in overcrowded conditions without adequate sanitation or veterinary care. (A)</p> Signup and view all the answers

What critical factor led to a surplus of chimpanzees in the 1990s, influencing their availability for research purposes?

<p>Significant funding from the National Institutes of Health (NIH), coupled with the use of chimps in military flight experiments and the establishment of the first primate laboratory. (B)</p> Signup and view all the answers

An organization that actively promotes deforestation to build new factories aligns with which environmental attitude?

<p>Development, characterized by the belief that nature is primarily for human use and that growth and expansion are paramount. (B)</p> Signup and view all the answers

A government implements strict fishing quotas to ensure fish populations remain stable for future generations. This policy best exemplifies which environmental attitude?

<p>Conservation, as it aims to balance resource use with the needs of future generations, ensuring sustainability. (A)</p> Signup and view all the answers

Which ethical philosophy posits that environmental resources should be accessible and beneficial to all living organisms, emphasizing the interconnectedness of life?

<p>Biocentrism (C)</p> Signup and view all the answers

If a previously endangered species has its population decline due to a novel virus, but is still extant, which criteria for delisting has it met?

<p>None (D)</p> Signup and view all the answers

Which of the following best captures the essence of 'The Tragedy of the Commons'?

<p>The overexploitation of a shared resource due to individual self-interest, leading to depletion and harm for all. (D)</p> Signup and view all the answers

A city council decides to rezone a large wetland area for commercial development, arguing that it will create jobs and increase tax revenue, despite concerns about habitat loss and increased flood risk. This decision primarily reflects which ethical viewpoint?

<p>Anthropocentrism, which prioritizes human well-being and economic gain over environmental concerns. (D)</p> Signup and view all the answers

Following the delisting of a species due to recovery, what long-term monitoring strategies are most crucial to ensure its continued success and prevent a reversal of its endangered status?

<p>Implementing annual population counts and habitat assessments, coupled with adaptive management strategies to address emerging threats. (C)</p> Signup and view all the answers

An institution is undergoing its triennial protocol review regarding animal use. If a member of the IACUC identifies a minor deviation from an approved protocol that does not compromise animal welfare, what action is permissible according to regulations?

<p>The member should consult with the attending veterinarian and the IACUC chair to determine if the deviation requires full committee review or can be addressed through administrative channels. (A)</p> Signup and view all the answers

A scientist proposes a significant modification to an ongoing animal research study. According to established regulations, which action must the IACUC take regarding the proposed changes?

<p>The proposed changes must undergo full committee review and approval before implementation. (C)</p> Signup and view all the answers

An institution's IACUC is tasked with reviewing animal welfare concerns raised by a technician. If the concerns involve allegations of mistreatment and neglect that could potentially compromise animal health, what immediate course of action should the IACUC prioritize?

<p>Initiate a thorough investigation of the allegations, ensuring confidentiality and protection for the reporting technician. (C)</p> Signup and view all the answers

The Endangered Species Act (ESA) outlines specific criteria for listing a species as endangered or threatened. Which of the following scenarios, if demonstrated, would NOT independently justify listing a species under the ESA?

<p>The species is affected by recreational hunting, managed to ensure sustainability. (A)</p> Signup and view all the answers

The Silver Spring monkeys case was a pivotal event that led to significant changes in animal welfare regulations. How did the established regulations directly address the ethical concerns highlighted by this case?

<p>By formalizing the requirement for Institutional Animal Care and Use Committees (IACUCs) to oversee animal research and care. (C)</p> Signup and view all the answers

The National Oceanic and Atmospheric Administration (NOAA) and the U.S. Fish and Wildlife Service (USFWS) share enforcement responsibilities under the Endangered Species Act (ESA). In what capacity does the NOAA contribute specifically to the ESA's objectives?

<p>By regulating activities that may affect listed marine and anadromous species and their habitats. (A)</p> Signup and view all the answers

An IACUC is reviewing a research proposal involving painful procedures on animals. Which consideration demonstrates the committee fulfilling its ethical responsibilities regarding the '3Rs' (Replacement, Reduction, Refinement)?

<p>Requiring a detailed justification for the chosen animal model, demonstrating that no alternatives exist and that the study design minimizes pain and distress. (C)</p> Signup and view all the answers

A researcher is found to be non-compliant with IACUC protocols related to post-operative animal care. Considering the IACUC's authority, what actions can they instigate to ensure proper compliance and animal welfare?

<p>The IACUC can mandate retraining for the researcher, increase monitoring frequency, and has the authority to suspend the researcher's animal use privileges if necessary. (B)</p> Signup and view all the answers

An IACUC member is also the lead scientist on a research protocol involving animal subjects. To avoid conflicts of interest during the triennial review, which aspect of the review process must be altered?

<p>The member must recuse themselves from discussions and voting related to their protocol to ensure impartiality. (D)</p> Signup and view all the answers

What distinguishes the role of the non-affiliated member of the IACUC from other members?

<p>They represent the general community's interests regarding animal welfare, offering an external perspective. (B)</p> Signup and view all the answers

In the context of the Endangered Species Act (ESA), what constitutes a 'regulatory mechanism', the inadequacy of which could lead to the listing of a species?

<p>Federal or state laws, policies, and management practices designed to protect the species or its habitat. (A)</p> Signup and view all the answers

A previously thriving species of migratory birds experiences a sudden and drastic population decline due to habitat loss in its wintering grounds, located in a country with lax environmental regulations. Despite local conservation efforts in its breeding grounds, the species continues to decline. Under what criteria of the ESA would this species qualify for listing?

<p>Under criteria related to habitat destruction and the inadequacy of existing regulatory mechanisms. (B)</p> Signup and view all the answers

What immediate action should be undertaken if an IACUC suspends a research activity involving animals due to severe non-compliance with approved protocols that compromises animal welfare?

<p>The institution must conduct a thorough investigation, remediate the non-compliance issues, and report to relevant regulatory agencies. (D)</p> Signup and view all the answers

Considering the history and outcomes associated with the Silver Spring monkeys case, what proactive measure would best prevent similar ethical violations in animal research?

<p>Enhancing training and oversight of animal care personnel and reinforcing the IACUC's authority. (B)</p> Signup and view all the answers

A proposed research study involves capturing and tagging a vulnerable population of endangered sea turtles. Despite the potential for valuable data collection, the IACUC raises concerns about the stress and potential harm to the turtles. Which ethical consideration should take precedence in the IACUC's decision-making process?

<p>Balancing the potential scientific gains against the potential harm to the vulnerable sea turtle population. (B)</p> Signup and view all the answers

What long-term ecological consequence might arise from the successful delisting of a species under the Endangered Species Act (ESA), and how can this be mitigated?

<p>A sudden increase in the species' population, leading to resource depletion and ecosystem imbalance; mitigated by continued habitat monitoring and adaptive management strategies. (B)</p> Signup and view all the answers

A researcher continues to use chimpanzees for invasive studies despite the NIH phasing out funding and a determination that they are not essential for biomedical research. What is the most likely consequence?

<p>The researcher may face severe penalties, including loss of funding, legal action, and damage to their professional reputation due to non-compliance. (D)</p> Signup and view all the answers

Which of the following scenarios best demonstrates an 'ecocentric' approach to environmental ethics?

<p>Establishing a wildlife sanctuary where human access is strictly limited to preserve the ecosystem's integrity. (D)</p> Signup and view all the answers

What is a primary consequence for investigators found in violation of the Animal Welfare Act (AWA) regulations during an unannounced inspection by APHIS?

<p>Imposition of monetary fines, the severity of which depends on the nature and extent of the non-compliance. (B)</p> Signup and view all the answers

Considering the restrictions stipulated by the Cruelty to Animals Act, under which circumstance would animal experimentation be deemed permissible?

<p>With the employment of anesthesia and when the research aims to advance the understanding, and treatment of human health (A)</p> Signup and view all the answers

A remote island ecosystem has a species of bird that was previously listed as endangered. After years of conservation efforts, the bird's population has significantly increased. What additional criteria must be met for the species to be considered for delisting, besides population recovery?

<p>Eliminating or sufficiently mitigating the threats that led to its initial decline. (D)</p> Signup and view all the answers

How did the Federal Food, Drug, and Cosmetic Act inadvertently affect animal experimentation practices despite its primary focus on public safety concerning drugs and cosmetics?

<p>By requiring animal testing to demonstrate the safety of drugs and medical devices prior to their release to the public, resulting in a surge in animal experimentation. (A)</p> Signup and view all the answers

How does the 'preservation' environmental attitude differ most significantly from the 'conservation' attitude?

<p>Preservation seeks to maintain ecosystems in their original state, while conservation allows for managed use that benefits both humans and the environment. (D)</p> Signup and view all the answers

What is the relationship between the Animal Welfare Act (AWA) and other animal-related laws, policies, and guidelines in the United States?

<p>The AWA serves as a foundational law that sets the minimum acceptable standards of care and treatment for animals, to which other regulations refer. (D)</p> Signup and view all the answers

Which scenario exemplifies 'The Tragedy of the Commons' in a marine ecosystem?

<p>Several fishing companies independently increase their fishing efforts in a shared fishing ground, leading to overfishing and depletion of fish stocks. (B)</p> Signup and view all the answers

What specific influence did the revelation of 'concentration camps for dogs' have on the legislative trajectory that culminated in the Animal Welfare Act (AWA)?

<p>It exposed a severe lack of regulation of the use of animals and increased the demand for minimum standards of care. (A)</p> Signup and view all the answers

Following the determination in 2015 that chimpanzees are generally not necessary for NIH-funded biomedical research, what primary ethical consideration now governs decisions about the remaining chimpanzees in research facilities?

<p>Balancing the potential scientific value of the research with the welfare and well-being of the individual chimpanzees. (D)</p> Signup and view all the answers

How does the structure and authority of the Animal and Plant Health Inspection Service (APHIS) contribute to its role in enforcing the Animal Welfare Act (AWA)?

<p>As a branch of the USDA, APHIS has the legal authority to conduct unannounced inspections and impose penalties, ensuring compliance with the AWA. (A)</p> Signup and view all the answers

An organization clears a large area of mangrove forest to create shrimp farms, arguing that this will boost the local economy and provide jobs, despite the ecological consequences. This action most closely aligns with which environmental attitude?

<p>Development, which prioritizes economic growth and resource exploitation for human benefit. (D)</p> Signup and view all the answers

How did increased industrialism contribute to the rise of the early conservation movement?

<p>By leading to increased population density, pollution, and resource depletion, raising awareness of environmental issues. (C)</p> Signup and view all the answers

If a research institution fails to meet even the most basic standards mandated by the Animal Welfare Act (AWA), what are the likely repercussions?

<p>The institution faces potential fines, restrictions on its ability to conduct animal research, and other enforcement actions by the USDA. (C)</p> Signup and view all the answers

During a routine inspection, APHIS identifies a severe and unaddressed violation of animal welfare standards at a research facility. What immediate action would APHIS be most likely to take?

<p>Temporarily suspend the facility's ability to conduct animal research, pending a thorough investigation and remediation of the violations. (B)</p> Signup and view all the answers

What action should the IACUC take if a research activity involving animals is suspended due to severe non-compliance that compromises animal welfare?

<p>Report the suspension to the appropriate regulatory agencies and ensure corrective actions are implemented before the activity can resume. (A)</p> Signup and view all the answers

How does the composition of the IACUC ensure diverse perspectives and prevent conflicts of interest?

<p>By mandating the inclusion of a non-affiliated member to represent general community interests and ensuring no single department dominates the committee. (A)</p> Signup and view all the answers

What constitutes 'inadequacy of existing regulatory mechanisms' as a criterion for listing a species under the Endangered Species Act (ESA)?

<p>Local or national regulations that are insufficient to prevent habitat destruction or overexploitation of the species. (C)</p> Signup and view all the answers

Which scenario would trigger mandatory reporting to regulatory agencies beyond the institution, concerning animal welfare?

<p>Discovery of severe, unaddressed animal mistreatment or neglect that violates federal regulations and compromises animal health. (A)</p> Signup and view all the answers

What key factor prompted the creation of Institutional Animal Care and Use Committees (IACUCs)?

<p>Public outcry and ethical concerns regarding the welfare and treatment of animals used in research. (D)</p> Signup and view all the answers

What would be considered actions that an IACUC is responsible for?

<p>Approving significant changes in ongoing research. (A)</p> Signup and view all the answers

If a researcher consistently violates IACUC protocols, neglecting post-operative animal care, what actions can the IACUC instigate to ensure compliance and animal welfare?

<p>Mandating retraining for the researcher, implementing closer monitoring of their experiments, and, if necessary, suspending the research activities until compliance is achieved. (B)</p> Signup and view all the answers

Considering the events of the Silver Spring monkeys case, what proactive step would be most effective in preventing similar ethical violations in animal research?

<p>Increasing the frequency of unannounced inspections of animal facilities and providing comprehensive training on animal handling and care for all personnel. (B)</p> Signup and view all the answers

Which of the following scenarios best exemplifies an anthropocentric ethical philosophy regarding environmental use?

<p>A city council approves the construction of a new dam to provide hydroelectric power and irrigation, despite the potential displacement of wildlife and alteration of river ecosystems. (A)</p> Signup and view all the answers

A rancher allows cattle to graze freely on communal land, resulting in soil erosion and reduced forage for other ranchers. This situation is an example of:

<p>The tragedy of the commons. (D)</p> Signup and view all the answers

What was a primary catalyst for the rise of the early conservation movement in response to industrialism?

<p>Increased population, city crowding, and sanitation issues. (C)</p> Signup and view all the answers

Which scenario best reflects the 'conservation' environmental attitude?

<p>A community implements a program to restore a degraded watershed, balancing human needs with the health and sustainability of the ecosystem. (A)</p> Signup and view all the answers

What criterion, if demonstrated, could lead to the delisting of a species?

<p>The species' population has recovered to a point where it no longer requires the protections of the Endangered Species Act. (D)</p> Signup and view all the answers

How did the combined impact of military flight experiments, the establishment of the first primate laboratory, and NIH funding influence the availability of chimpanzees for research in the latter half of the 20th century?

<p>These factors collectively triggered a surge in chimpanzee breeding, leading to a surplus of chimpanzees available for research purposes in the 1990s. (C)</p> Signup and view all the answers

An environmental group advocates for maintaining a wilderness area completely untouched by human development, believing that it has intrinsic value independent of human use. This perspective aligns with which environmental attitude?

<p>Preservation (D)</p> Signup and view all the answers

Which ethical philosophy extends moral consideration to all living and non-living components of the environment?

<p>Ecocentrism (B)</p> Signup and view all the answers

A research lab consistently fails to provide adequate veterinary care to its research animals, despite repeated warnings from APHIS. Considering the enforcement mechanisms of the AWA, what is the most severe penalty APHIS can impose?

<p>Suspension or revocation of the facility's registration, along with significant monetary penalties. (B)</p> Signup and view all the answers

A biomedical company conducts animal testing for a new cosmetic product. If they fail to adhere to the standards of care outlined in the AWA, what is the most likely repercussion, considering the AWA's regulatory framework?

<p>The company may face fines and/or suspension or revocation of its registration to conduct animal research. (D)</p> Signup and view all the answers

A researcher conducts a surgical experiment on an animal without providing anesthesia, arguing that anesthesia interferes with the physiological parameters being measured. How would this situation be viewed under the Cruelty to Animals Act?

<p>A direct violation of the Act, as it mandates the use of anesthesia during experiments. (C)</p> Signup and view all the answers

A research facility is found to be using a single animal for multiple experimental procedures over an extended period, despite the availability of alternative methods. How does this contravene the Cruelty to Animals Act?

<p>It contravenes the act because animals are only to be used one time. (A)</p> Signup and view all the answers

After the implementation of the Federal Food, Drug, and Cosmetic Act, a significant increase was seen in animal testing. What was a downside of this increase?

<p>There were loose guidelines with no official oversight and no means of punishment. (B)</p> Signup and view all the answers

What was the primary impetus behind the creation of the Animal Welfare Act (AWA)?

<p>The expose of 'concentration camps' for dogs, which revealed the kidnapping of pets for research in unsanitary conditions. (D)</p> Signup and view all the answers

How does the Animal Welfare Act (AWA) establish a baseline standard for animal care across various regulated entities?

<p>By serving as the minimally acceptable standard to which all other animal-related laws, policies, and guidelines refer. (A)</p> Signup and view all the answers

A research institution is found to be in repeated non-compliance with the Animal Welfare Act (AWA) standards regarding the housing and care of primates. Despite warnings, conditions have not improved. What is the most likely sequence of actions that APHIS will take?

<p>APHIS will conduct unannounced inspections, issue fines, and potentially suspend or revoke the facility's registration if compliance isn't achieved. (C)</p> Signup and view all the answers

Flashcards

IACUC Responsibilities

Review institution's animal use, inspect facilities, report findings, address welfare concerns, approve animal-related activities, changes in research, and activity suspension.

IACUC Membership

Minimum of 3, including a chair, vet with research experience, practicing scientist, non-scientist, and someone unaffiliated with the institution.

Silver Springs Monkeys Experiment

Experiment involving sensory nerve cut in monkeys arm, forced relearning. Ethical laws broken: failure to care, house monkeys.

Outcomes of Silver Springs Monkeys

IACUC and PETA were created

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Events Leading to ESA

Bald Eagle and Devils Hole Pupfish decline

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Endangered Species Act (ESA) Regulation

Provides protection to prevent extinction; listed species can't be killed, lands protected.

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ESA Enforcement

National Oceanic and Atmospheric Administration and the U.S. Fish and Wildlife Service.

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ESA Listing Criteria

Habitat destruction, overuse by humans, disease/predation, inadequate regulations, other natural/manmade factors.

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HeLa Cells

Immortal cell line derived from Henrietta Lacks without her consent for research.

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Vivisection

Surgery conducted on a living organism for experimental purposes.

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Cruelty to Animals Act

An Act created due to anti-vivisectionist movements, designed to regulate animal experimentation. Limited experiments to teaching or saving human life, required anesthesia, and mandated single use.

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Federal Food, Drug, and Cosmetic Act's Role in Animal Experiments

Required drugs and devices to prove safety via animal testing before public release, leading to increased animal use in research. Lacked official oversight.

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Animal Welfare Act (AWA)

Federal law setting minimum care standards (housing, sanitation, food, veterinary care) for animals in research.

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Concentration camps for dogs

Kidnapping of pets to be sold to scientific research and kept in unsanitary/unsafe conditions

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AWA Regulations

Sets minimum standards of care regarding housing, sanitation, food, water, veterinary care

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APHIS's Role

Branch of the USDA that enforces the Animal Welfare Act (AWA). Performs inspections and issues fines.

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Delisting Criteria

Extinction and Recovery

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Development (Environmental Attitude)

Nature is purely for human use; bigger is better, growth focused.

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Preservation (Environmental Attitude)

Nature has value, and people must use it sustainably for future generations.

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Conservation (Environmental Attitude)

Nature has value in itself and should be protected, undisturbed.

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Anthropocentrism

The environment is only for people to use.

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Biocentrism

All living things can use the environment.

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Ecocentrism

All living and non-living things can use the environment.

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Tragedy of the Commons

Overusing a shared resource, leading to its depletion or destruction.

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IACUC

A committee that reviews and approves the use of animals in research at an institution.

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IACUC Protocol Review

Every three years.

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IACUC Chair Selection

Appointed by the institute.

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Purpose of the ESA

To provide protection to prevent extinction.

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ESA Prohibitions

Killing, hunting, or collecting listed species.

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ESA Listing Factors

Habitat destruction, overuse, disease/predation, inadequate regulations, and other factors.

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IACUC unaffiliated member

One member must not be affiliated with the institution or other committee members.

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IACUC minimum size

Minimum of 3 members.

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Vivisection Definition

Surgery on living animals for experimental purposes.

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Cruelty to Animals Act - Origin

Originally intended to minimize animal suffering in entertainment.

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Cruelty to Animals Act - Regulations

Experiments allowed for teaching/saving human life, anesthesia required, single use only.

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FFDCA's Impact on Animal Testing

Required drug safety be proven in animals before public release.

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AWA - Events Leading to Creation

Concentration camps for dogs being sold for research in unsafe environments.

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Animal Welfare Act (AWA) Regulations

Sets minimum care standards for lab animals: housing, sanitation, food, veterinary care.

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Cause of Chimp surplus in the 90s?

Closest genetic relatives, military flight experiments, and NIH funding.

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Why aren't chimps being used in research now?

Cannot develop full blown AIDS, NIH phased out funds and a committee determined chimps are not needed.

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Current state of research chimps?

Retired to sanctuaries or are still in labs but in inactive use.

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What is Preservation?

Recognize that nature has a value, yet realize that people must exploit nature in a sustainable manner, offering the greatest good to the greatest number of people for the longest period of time, exploiting but sharing with future generations.

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Events Leading to Conservation Movement

Industrialism leading to increased population and city crowding which lead to sewage and sanitation issues.

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What does Anthropocentrism believe?

Environment is for people to use

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What does Biocentrism believe?

All living things can use the environment.

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Chimpanzees research role?

Role: Closest relative. Cause for surplus: military flight experiments, NIH funding. Not used: can't get AIDS, funding off. Current state: retired.

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What is Vivisection?

Surgery conducted for experimental purposes on a living organism.

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Federal Food, Drug, and Cosmetic Act impact?

Required drugs and devices were required to prove safety in animals, before release to the public.

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Animal Welfare Act (AWA) Minimum Standards

Sets minimum standards of care regarding housing, sanitation, food, water, veterinary care.

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AWA Scope

Federal Law in US.

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APHIS's role with the AWA

Animal and Plant Health Inspection Service (APHIS) is a branch of the USDA that oversees the AWA.

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ESA Delisting

Due to extinction or recovery of the species.

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Chimpanzee research use

Chimps were studied due to being our closest genetic relative.

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Cause of Chimp surplus (90s)

Military flight experiments, first primate laboratory, and NIH funding.

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Why chimps aren't used now

Cannot develop full-blown AIDS, NIH funding phased out, determined unnecessary for research.

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Development (Environmental)

Recognizes nature has value, for human use; bigger is better, growth.

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Anthropocentrism defintion

Environment is for people to use

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Early conservation impetus

Industrialism leading to increased population which lead to city crowding, sewage and sanitation issues.

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