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31 Cards in this Set

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  • Back
• What is regulatory toxicology?

o It uses data from descriptive and mechanistic tox. To perform risk assessments. It is concerned with meeting the requirements of regulatory agencies.

• What are some examples of US Federal regulatory agencies?

o FDA, USDA, EPA, OSHA, CPSC, Animal Welfare Act, etc.

• What is the FDA?

o It is the Food and Drug Administration which is an Executive Branch Agency. It is under the Secretary of Human Health Services. It requires senate confirmation.

• What was the Vaccine Act of 1813 and the Biologics Act of 1902?

o These were early laws by the FDA.
o The Vaccine Act was made because of a bad smallpox vaccine event. It was the first federal law dealing with consumer protection and drugs, but it was short lived.
o The Biologics Act of 1902 was passed after deaths due to bad diphtheria antitoxin.

• What was the 1906 Act?

o It outlined the basic structure of the FDA.
o It gave the FDA authority over interstate shipment of adulterated food and drugs.

• What was the 1938 act?

o It allowed the FDA to consider cosmetics as well. It also broadened the definitions of adulteration and misbranding of products. This was in response to a pediatric elixir being adulterated with ethylene glycol which lead to death in patients.

• What was the 1962 Amendments?

o It shifted from premarket notifications to premarket approval for products.
o It required drugs to be effective
o It required a reevaluation of all marketed drugs. This is still not finished

• What was the Medical Device Amendments of 1976?

o The goal was to regulate medical devices to make sure they were safe for patients.
o They required all new devices to be safe and effective. They required Risk Class regulation.
o It passed after the scandals involving pacemakers and other medical devices.

• What does the Department of Agriculture do?

o It ensures products are safe and that there aren’t high levels of contaminants of pesticides in the food.
o It has the Food Safety Inspection Service (FSIS) which inspects meat, poultry, and eggs.

• What is the EPA and when was it founded?

o It is the Environmental Protection Agency and it was founded in 1970. Its goal is to protect health and environment related to air, water, and soil pollution with risk benefit considerations. o It is also works to streamline and strengthen the regulation of pesticides.


• What kind of policies did the EPA enact?

o Federal Insecticide, Fungicide, and Rotendicide Act (FIFRA) 1947-1972
o Toxic Substances Control Act (TSCA) 1976
o Resources Conservation and Recovery Act 1976
o They also did things like the Water Pollution Control act/Clean Water Act, Safe Drinking water Act, and the Clean Air Act.

• What did FIFRA do?

o It required premarket testing of pesticides. (testing efficacy, safety, and environmental impact).
o It established testing procedures.
o It established tolerances
o It also had post-market environmental surveillance monitoring.
o It required registration of pesticide producing facilities
o It required the classifications of pesticides
o It banned certain pesticides like DDT
o It created risk-benefit evaluations

• What did the Toxic Chemical Substance Act (TCSA) do?

o It intended to bring industrial chemicals under the oversight of EPA
o It tried to regulate chemicals that pose an unreasonable risk to health and environment.
o It prevented the reoccurrence of industrial exposures and accidents of dangerous chemicals.
o It required pre-manufacture testing of new chemicals or new uses of old chemicals (but not for pesticides or food additives)
o It covers manufacture, use, distribution, and disposal of any toxic substance.
o It also established risk benefit analyses. (required tests to be done and if found to be harmful, it had to be reported.)

• What does the Research Conservation and Recovery Act do?

o It controls generation, shipping, storage, treatment, and record keeping related to hazardous wastes.
o It also sets guidelines for testing them and designs storage facilities for them.

• What did the National Institute for Occupational Safety and Health (NIOSH) develop and what does this act do?

o They developed the Occupational Safety and Health Act (OSHA)
o It sets health standards in the workplace about things like toxic chemicals, stress, noise, etc.
o It trains personnel, educates workers, and give them protective gear to prevent problems.
o All actions are retrospect. You must prove a problem exists.

• What is the Consumer Product and Safety Commission?

o It protects the public from risk/injury from consumer products. It regulates mostly by requiring labeling.
o It sets standards and evaluates safety of consumer products (i.e. flammable clothing, childproof lids, etc.) but it excludes items covered by other agencies (like pesticides, alcohol and drugs)
o It lacks pre-market authority.

• What was the lash lure tragedy of 1930?

o It was a product that put out an ad for better eyebrows and lashes. However, people using the products suffered from allergic reactions, severe pain, blindness, and even death.

• What was the impact of legislation on product evaluation and approval in the past and in the present?

o In the past, laws were more focused on proving the safety and efficacy of products and getting pre-market approval as well as post-market regulation. There was also a bug increase in animal studies.
o In the present, we are finding ways to replace, reduce and refine animal use in research and testing. We are trying to increase efficiency and reduce times for regulatory acceptance and implementation.

• What is the Institutional Animal Care and Use Committees (IACUC)? What does it do? Who is it composed of?

o It is a committee that has to be established at each institution using animals for research, testing, and education. They give the approval for animal use.
o The committee must include a vet with training and experience in lab animal medicine, a person who is not a scientist, and a person not affiliated with the institution.

• According to the IACUCs, what must be done to get approval to use animals in studies?

o Investigators have to provide sources and methods used to determine that alternatives are not available whenever animal use involves more than slight/momentary pain or distress.
o They have to consider alternative methods that will reduce, replace, or refine animal use
o They have to provide scientific rationale why available alternatives are not scientifically acceptable to accomplish the objectives.
o All personnel involved with the care/use of animals have to be trained in use and availability of methods that will reduce, refine, and replace animals.

• What did the ICCVAM Authorization Act of 2000 do?

o It ensured that new/revised/alternative test methods are scientifically validated to meet agency needs and are more predictive of human health and ecological effects.
o It also urged increase in efficiency/effectiveness of agency test method review
o Eliminated unnecessary duplicative efforts and established more communication within the different agencies.
o Reduce/refine/replace animal use in testing when possible.

• Define relevance

o The extent to which a test method will correctly predict or measure the biological effect of interest.

• Define reliability

o The measure of the extent to which a test can be performed reproducibly within and among other labs over time

• Define validation

o Process by which the reliability and relevance of a test method are established vis-à-vis its proposed use.

• What is Proposition 65?

o It is part of the Safe Drinking Water and Toxic Enforcement Act of 1986.
o It is a labeling/notification regulation. It is a list containing naturally occurring and synthetic chemicals known to the state to cause cancer, birth defects, or other reproductive harm. Businesses have to show a clear indication/warning that they might have some of these in the products that are being sold.

• What are the exemptions from the labeling requirement of Prop 65?

o Businesses with less than 10 employees and government agencies don’t need them.
o Exposures caused by the products that are so low in concentration that they don’t create a significant risk also don’t need them. (anything below the Safe Harbor Level)

• What is the Cali Green Chem Initiative and how does it work?

o It is one of the first laws that has to do with green chemistry and the goal is to find safer alternatives to chemicals of concern.
o First they make an initial list of candidates (about 1200 chemicals), then there is an identification of 3-5 priority products each with a candidate chemical. The priority product list is finalized and the companies with these products have 60 days to come up with an alternative/change concentrations/remove product from market.


• If you market a priority product in Cali, what are you required to do?

o Notify DTSC that you are marketing the priority product within 60 days of list finalization.
o Elect to perform an alternative assessment or notify DTSC of intent to remove/replace chemical from product, remove/replace product altogether, or provide information showing that the chemical of concern is below the AA threshold.

• How long is the Alternative Assessment time table?

o It can take up to 2 years following the final publication of the Priority Product for replacement. You could also get deadlines.

• What is the Walmart Retail Store Regulation?

o Walmart is looking for their suppliers to reduce/eliminate the use of ingredients that they identify as priority chemicals in favor of safer alternatives.
o The high priority chemicals list is not publicly disclosed. They require that the companies do the testing and figure it out.
o Walmart requires that suppliers disclose their full product formulations through a WERCS software which tells the supplier that they have a product on the priority list.
o Walmart will also monitor these products and if suppliers don’t comply, Walmart will prohibit sales, take product down, give it small shelf space for selling, etc.)

• What is EU REACH? What does it do?

o It is a global regulation institution that monitors and has the safety of chemicals evaluated.
o REACH= Registration, Evaluation, Authorization of CHemicals.
o It is a single system for existing and new substances. It shifts the responsibility/workload and burden of proof from authorities to the industry. It bans substances of very high concern. It made a new chemical agency to manage the system.