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87 Cards in this Set

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What are exposure standards and guidelines?
Exposure standards and guidelines are developed by governments to protect the public from harmful substances and activities that can cause serious health problems. Exposure standards and guidelines are the products of risk management decisions.
Risk assessments provide regulatory agencies with what?
Risk assessments provide regulatory agencies with estimates of numbers of persons potentially harmed under specific exposure conditions. Regulatory agencies then propose exposure standards and guidelines which will protect the public from unacceptable risk.
Exposure standards and guidelines usually provide what for various media that cannot be exceeded. Alternatively, these standards may also be what?
Exposure standards and guidelines usually provide numerical exposure levels for various media (such as food, consumer products, water and air) that cannot be exceeded. Alternatively, these standards may be preventive measures to reduce exposure (such as labeling, special ventilation, protective clothing and equipment, and medical monitoring).
What are the two types of exposure standards and guidelines?
1. Standards

2. Guidelines
Describe 'standards'?
These are legal acceptable exposure levels or controls issued as the result of congressional or executive mandate. They result from formal rule making and are legally enforceable. Violators are subject to punishment, including fines and imprisonment.
Describe 'guidelines'?
These are recommended maximum exposure levels which are voluntary and not legally enforceable. Guidelines may be developed by regulatory and non-regulatory agencies, or by some professional societies.
Federal and state regulatory agencies have the authority to issue what?
Federal and state regulatory agencies have the authority to issue permissible exposure standards and guidelines.
Federal and state regulatory agencies have the authority to issue permissible exposure standards and guidelines. List 3 categories they include.
1. Consumer Product Exposure Standards and Guidelines

2. Environmental Exposure Standards and Guidelines

3. Occupational Exposure Standards and Guidelines
Exposure standards or guidelines are:





Unacceptable levels of exposure that must be avoided




Acceptable levels of exposure that should not be exceeded
Exposure standards or guidelines are acceptable levels of exposure that should not be exceeded. These levels should protect the public from harmful exposures.
Legal exposure standards are:





Acceptable exposure levels that are enforceable if exceeded.




Acceptable exposure levels which are not legally enforceable and adherence is voluntary.




Developed by the Department of Health and Human Services (DHHS) and professional societies.
Legal exposure standards are acceptable exposure levels that are enforceable if exceeded. Violators are subject to punishment, including fines and imprisonment.
Manufacturers of new pharmaceuticals are required to obtain what before their products can be marketed?
Manufacturers of new pharmaceuticals are required to obtain formal FDA approval before their products can be marketed.
Drugs intended for use in humans must be tested in ? to determine toxic dose levels as a part of the ?.
Drugs intended for use in humans must be tested in humans (in addition to animals) to determine toxic dose levels as a part of the new drug application (NDA).
What does the NDA cover?
The NDA covers all aspects of a drug's effectiveness and safety, including:

1. Pharmacokinetics and pharmacological effects

2. Metabolism and mechanism of action

3. Associated risks of the drug

4. Intended uses and their effectiveness

5. Benefit-risk relationship

6. Basis for package inserts supplied to physicians
The FDA does not what for drugs? Instead, what does the FDA approve?
The FDA does not issue exposure standards for drugs. Instead, FDA approves an NDA which contains guidance for usage and warnings concerning effects of excessive exposure to the drug.
The manufacturer is required to provide NDA information to whom?
The manufacturer is required to provide this information to physicians prescribing the drug as well as to the others that may purchase or use the drug.
Information on a drug's harmful side effects is provided in three main ways: List them.
1. Labeling and package inserts that accompany a drug and explain approved uses, recommended dosages, and effects of overexposure

2. Publication of information in the Physicians' Desk Reference (PDR)

3. Information dissemination to physicians via direct mailing or by publications in medical journals
The package insert labels and the PDR contain what 11 pieces of information pertaining to the drugs?
1. Description

2. Clinical pharmacology

3. Indications and usage

4. Contraindications

5. Warnings

6. Precautions

7. Adverse reactions

8. Interactions

9. Overdosage

10. Available forms

11. Dosage and administration
The FDA is responsible for the approval of what?
The FDA is responsible for the approval of food additives.
FDA standards are different depending on what?
Standards are different depending on whether they are direct food additives or indirect food additives.
Direct food additives are what? Give examples. Approval usually designates the maximum allowable concentrations (e.g., 0.05%) in a food product.
Direct food additives are intentionally added to foods for functional purposes. Examples of direct food additives are processing aids, texturing agents, preservatives, flavoring and appearance agents, and nutritional supplements. Approval usually designates the maximum allowable concentrations (e.g., 0.05%) in a food product.
What are indirect food additives?
Indirect food additives are not intentionally added to foods and they are not natural constituents of foods. They become a constituent of the food product from environmental contamination during production, processing, packaging and storage. Examples of indirect food additives are antibiotics administered to cattle, pesticide residues remaining after production or processing of foods, and chemicals that migrate from packaging materials into foods. Exposure standards indicate the maximum allowable concentration of these substances in food.
New direct food additives must undergo what?
New direct food additives must undergo stringent review by FDA scientists before they can be approved for use in foods.
The manufacturer of a direct food additive must provide what?
The manufacturer of a direct food additive must provide evidence of the safety of the food additive in accordance with specified uses.
The safety evaluation of a direct food additive is conducted by what?
The safety evaluation is conducted by the toxicity testing and risk assessment procedures previously discussed with derivation of the ADI.
In contrast to pharmaceutical testing, virtually all toxicity evaluations are conducted with what?
In contrast to pharmaceutical testing, virtually all toxicity evaluations are conducted with experimental laboratory animals.
In 1958, with an amendment to what, the FDA was required to approve all new food additives?
In 1958, with an amendment to the Food, Drug and Cosmetic Act (FDCA), FDA was required to approve all new food additives.
In 1958; the law at that time decided that all existing food additives were generally what?
The law at that time decided that all existing food additives were generally recognized as safe (known as GRAS) and no exposure standard was developed. Many of these GRAS substances have more recently been re-evaluated and maximum acceptable levels have been established.
The FDA re-evaluation of GRAS substances requires what?
The FDA re-evaluation of GRAS substances requires that specific toxicity tests be conducted based on the level of the GRAS substance in a food product. For example, the lowest level of concern is for an additive used at 0.05 ppm in the food product. Only short-term tests (a few weeks) are required for those compounds. In contrast, a food additive used at levels higher than 1.0 ppm must be tested for carcinogenicity, chronic toxicity, reproductive toxicity, developmental toxicity, and mutagenicity.
The 1958 amendment to the FDCA law for FDA is known as what?
The 1958 amendment to the FDCA law for FDA is known as the Delaney Clause.
What does the Delaney Clause prohibit?
This clause prohibits the addition of any substance to food that has been shown to induce cancer in man or animals. The implication is that any positive result in an animal test, regardless of dose level or mechanism, is sufficient to prohibit use of the substance. In this case, the allowable exposure level is zero.
Consumer exposure standards are developed for hazardous substances and articles by who?
Consumer exposure standards are developed for hazardous substances and articles by the Consumer Product and Safety Commission (CPSC).
Consumer Product and Safety Commission's authority under the Federal Hazardous Substance Act pertains to what?
Consumer Product and Safety Commission (CPSC). Their authority under the Federal Hazardous Substance Act pertains to substances other than pesticides, drugs, foods, cosmetics, fuels, and radioactive materials.
The CPSC requires a warning label on a what? Highly toxic substances are labeled with what? Less toxic substances are labeled with what?
The CPSC requires a warning label on a consumer product which is toxic, corrosive, irritant, or sensitizer. Highly toxic substances are labeled with DANGER; less toxic substances are labeled with WARNING or CAUTION.
The basis for highly toxic is death in laboratory ? at an oral dose of ?, an inhaled dose in ? of ? , and a ? in ? of ?.
The basis for highly toxic is death in laboratory rats at an oral dose of 50 mgs, an inhaled dose in rats of 200 ppm for one hour, and a 24-hour dermal dose in rabbits of 200 mg/kg.
A substance is corrosive if it causes what?
A substance is corrosive if it causes visible destruction or irreversible damage to the skin or eye.
When is a substance considered an irritant?
If it causes damage which is reversible within 24 hours, it is designated an irritant.
What is sufficient for the designation of a substance as a sensitizer?
An immune response from a standard sensitization test in animals is sufficient for designation as a sensitizer.
Exposure standards for pharmaceuticals are:





Issued by the Food and Drug Administration as legal standards




Developed by the Environmental Protection Agency




Recommended guidance developed by the FDA
Exposure standards for pharmaceuticals are recommended guidance developed by the FDA. Exposure guidance is a part of the package insert labels and is published in the Physicians' Desk Reference. Physicians are not obligated to conform to the recommended guidance and can exceed usage guidelines and use their medical judgment.
The FDA develops exposure standards for both direct food additives and indirect food additives. An example of an indirect food additive is:





A substance added to foods as a preservative




A pesticide residue encountered during production or processing of foods




A nutritional supplement, e.g., Vitamin A
The FDA develops exposure standards for both direct food additives and indirect food additives. An example of an indirect food additive is a pesticide residue encountered during production or processing of foods.
Under the Delaney clause, the FDA is:





Prohibited from allowing the addition of any substance to foods that has been shown to cause cancer in humans or animals




Authorized to establish exposure standards for substances that have been shown to cause cancer in humans or animals




Authorized to determine acceptable exposure levels for indirect food additives that are known to cause cancer in humans and animals
Under the Delaney clause, the FDA is prohibited from allowing the addition of any substance to foods that has been shown to cause cancer in humans or animals. The Delaney Clause is a highly controversial law. Other regulatory statutes allow risk assessments to determine allowable exposure levels for carcinogenic substances.
Who is responsible for several laws that require determination and enforcement of exposure standards?
The Environmental Protection Agency is responsible for several laws that require determination and enforcement of exposure standards. In addition, they have the authority to prepare recommended exposure guidelines for selected environmental pollutants.
The EPA is responsible for developing exposure standards for what?
1. Pesticides

2. Water pollutants

3. Air pollutants

4. Hazardous wastes
Pesticides can not be marketed until they have been what?
Pesticides can not be marketed until they have been registered by the EPA in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
In order to obtain registration, a pesticide must undergo what?
In order to obtain registration, a pesticide must undergo an extensive battery of toxicity tests, chemistry analyses, and environmental fate tests.
In cases where the toxicity warrants, a pesticide may be approved for what?
In cases where the toxicity warrants, a pesticide may be approved for restricted uses.
A primary exposure standard for pesticides is what? This standard specifies what?
A primary exposure standard for pesticides is the pesticide tolerance for food use. This standard specifies the amount of pesticide that is permitted on raw food products (e.g., tolerance for chlorpyrifos on corn).
Water pollutants are regulated by what two laws
1. The Safe Drinking Water Act (SDWA)

2. The Clean Water Act (CWA).
Under the SDWA, the EPA conducts what?
Under the SDWA, the EPA conducts risk assessments and issues maximum contaminant levels (MCLs) for chemicals in drinking water.
What is a maximum contaminant level (MCLs)?
The MCL is the acceptable exposure level which, if exceeded, requires immediate water treatment to reduce the contaminant level. For example, the MCL for trichloroethylene is 0.005 mg per liter of water.
.
In addition to establishing MCLs, the EPA can propose recommended what?
In addition to establishing MCLs, the EPA can propose recommended exposure guidance for drinking water contamination
As an interim procedure, what may be recommended for long term exposures to contaminants in drinking water
As an interim procedure, maximum contaminant level goals (MCLGs) may be recommended for long term exposures to contaminants in drinking water.
Generally, no allowable exposure can be recommended for a what?
Generally, no allowable exposure can be recommended for a carcinogenic chemical.
What is an HA?
EPA prepares health advisories (HAs) as voluntary exposure guidelines for drinking water contamination.
The HAs provide exposure limits for what exposure periods?
The HAs provide exposure limits for 1-day, 10-day, longer-term, or lifetime exposure periods.
HAs pertain only to what risks?
They pertain only to non-carcinogenic risks.
How does the formula for HAs differ from that for the ADI or RfD?
The formula used to derive a health advisory differs from that for the ADI or RfD in that the HAs pertain to short-term as well as long-term exposures. In addition, human body weight and drinking water consumption are included in the formula.
The basic formula for an HA is in what units?
The basic formula for an HA is in mg/L.
Give the basic formula for HA.
HA = ((NOAEL or LOAEL) * Body wt.)/ (water consumption * UF)

(body wt = 10kg for a child; 70kg for an adult)

(Water consumption = 1 L/day for child; 2 L/day for an adult)

(UF = uncertainty factor)
What must conform with the human exposures covered by the HAs? Give an example.
The durations and exposure route (oral) of the toxicology studies to be employed for HA assessments must conform with the human exposures covered by the HAs. For example, the NOAEL or LOAEL for derivation of a 10-day HA would be obtained from an animal toxicology study of approximately 10 days duration (routinely 7-14 day toxicity studies).
A longer-term HA applies to who?
A longer-term HA applies to humans drinking contaminated water for up to 7 years (10% of a human's 70-year lifespan). Since 90 days is about 10% of a rats expected lifespan, the 90-day subchronic study with rats is appropriate for derivation of the longer-term HA assessment
A life-time HA (representing lifetime exposure to a toxicant in drinking water) is also determined for what?
A life-time HA (representing lifetime exposure to a toxicant in drinking water) is also determined for non-carcinogens. The procedure uses the RfD risk assessment with adjustments for body weight of an adult human (70 kg) and drinking water consumption of 2 L/day.
In addition to drinking water standards, the EPA is authorized under the Clean Water Act (CWA) to issue what?
In addition to drinking water standards, the EPA is authorized under the Clean Water Act (CWA) to issue exposure guidance for control of pollution in ground water. The intent is to provide clean water for fishing and swimming rather than for drinking purposes. It provides a scheme for controlling the introduction of pollutants into navigable surface water. The recommendations for ground water protection are known as ambient water quality criteria.
The ambient water quality criteria are intended to control what?
The ambient water quality criteria are intended to control pollution sources at the point of release into the environment. While these criteria may be less restrictive than the drinking water standards, they usually are the same numeric value. For example, the MCL (for drinking water) and the ambient water quality criteria (for ground water) for lead are the same (0.05 mg per liter of water).
What are issued by EPA under the Clean Air Act (CAA)?
Air emission standards are issued by EPA under the Clean Air Act (CAA).
The CAA authorizes the issuance of what for air pollution?
The CAA authorizes the issuance of national ambient air quality standards (NAAQS) for air pollution.
What are the different types of NAAQS?
There are two types of NAAQS. Primary NAAQS pertain to human health, whereas secondary NAAQS pertain to public welfare (such as crops, animals, and structures).
NAAQS have been established for the what major atmospheric pollutants?
NAAQS have been established for the following major atmospheric pollutants: carbon monoxide, sulfur oxide, oxides of nitrogen, ozone, hydrocarbons, particulates, and lead.
When air emissions exceed the NAAQS levels, the polluting industry must do what?
When air emissions exceed the NAAQS levels, the polluting industry must take control measures to reduce emissions to the acceptable level.
Hazardous wastes are regulated under what?
Hazardous wastes are regulated under the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), commonly known as Superfund.
RCRA regulates hazardous chemical waste produced by what?
RCRA regulates hazardous chemical waste produced by industrial processes, medical waste and underground storage tanks.
The main purpose of CERCLA is to clean up what?
The main purpose of CERCLA is to clean up hazardous waste disposal sites.
EPA has established standards known as Reportable Quantities (RQs). What are these?
Related to hazardous waste disposal. EPA has established standards known as Reportable Quantities (RQs). Companies must report to EPA any chemical release that exceeds the RQ. The RQ for most hazardous substances is one pound.
ATSDR derives Minimal Risk Levels (MRLs) for what?
ATSDR derives Minimal Risk Levels (MRLs) for noncancer toxic effects.
MRLs are estimates of what?
MRLs are estimates of daily human exposures that are likely to be without an appreciable risk of adverse effects over a specified duration of exposure. MRLs are derived for acute (14 days or less), intermediate (15-364 days), and chronic (365 days or more) exposures for inhalation or oral routes.
The exposure standard established by the EPA for pesticides that may contaminate foods is known as the:





Pesticide Direct Food Additive Level




Reportable Quantity




Pesticide Tolerance for Food Use
The exposure standard established by the EPA for pesticides that may contaminate foods is known as the Pesticide Tolerance for Food Use. The EPA is responsible for establishing the pesticide tolerances whereas the FDA is responsible for enforcement actions in the event tolerance levels are exceeded.
The EPA establishes exposure standards for chemical contaminants in drinking water which are known as:





Maximum Contaminant Levels




Ambient Water Quality Criteria




Maximum Contaminant Level Goals
The EPA establishes exposure standards for chemical contaminants in drinking water which are known as Maximum Contaminant Levels. The MCL is the acceptable exposure level of a chemical in drinking water which, if exceeded, requires immediate treatment of the water to reduce the contaminant level.
The ATSDR derives estimated levels for daily human exposure to chemicals that are likely to be without an appreciable risk of adverse effects for specified periods of exposure. These are know as:





Health Advisories




National Ambient Air Quality Standards




Minimum Risk Levels
The ATSDR derives estimated levels for daily human exposure to chemicals that are likely to be without an appreciable risk of adverse effects for specified periods of exposure. These are know as Minimum Risk Levels. The ATSDR establishes Minimum Risk Levels for three durations of inhalation or oral exposure. Durations are acute (14 days or less), intermediate (15-364 days), and chronic (365 days or more).
Legal standards for workplace exposures are established by what?
Legal standards for workplace exposures are established by the Occupational Safety and Health Administration (OSHA).
Legal standards for workplace exposures are established by the Occupational Safety and Health Administration (OSHA). What are these standards known as?
These standards are known as Permissible Exposure Limits (PELs).
Most OSHA PELs are for what? This is known as what?
Most OSHA PELs are for airborne substances with allowable exposure limits averaged over an 8-hour day, 40-hour week. This is known as the Time-Weighted-Average (TWA) PEL. Adverse effects should not be encountered with repeated exposures at the TWA PEL.
OSHA also issues ?, ?, and ?.
OSHA also issues Short Term Exposure Limit (STELs) PELs, Ceiling Limit PELs, and PELs that carry a skin designation.
What are PEL STELs?
PEL STELs are concentration limits of substances in the air that a worker may be exposed to for 15 minutes without suffering adverse effects. The 15 minute STEL is usually considerably higher than the 8-hour TWA exposure level. For example, for trichloroethylene the PEL-STEL is 200 ppm whereas the PEL-TWA is 50 ppm.
What are Ceiling Limit PELs?
Ceiling Limit PELs are concentration limits for airborne substances that should never be exceeded.
What is a skin designation?
A skin designation indicates that the substance can be readily absorbed through the skin, eye or mucous membranes, and substantially contribute to the dose that a worker receives from inhalation of the substance.
Could an occupational substance have PELs as TWA, STEL, Ceiling Limit, and a skin designation?
Theoretically, an occupational substance could have PELs as TWA, STEL, and Ceiling Limit, and with a skin designation. This is rare however. Usually, a OSHA regulated substance will have only a PEL as a time-weighted average. About 20% of the OSHA regulated substances have PEL-STELs and only about 10% have skin notations. In a few cases, a substance may have a PEL-Ceiling but not a PEL-TWA.
What is the 'Dangerous to Life and Health'(IDLH)?
An occupational exposure guideline developed by the OSHA Standards Completion Program is the Immediately Dangerous to Life and Health (IDLH). This represents a maximum level that a human could be exposed to for up to 30 minutes and escape from without any serious health effects.
The Occupational Safety and Health Administration develops workplace exposure standards known as:





Threshold Limit Values (TLVs)




Permissible Exposure Limits (PELs)




NIOSH Recommended Exposure Limits (RELs)
The Occupational Safety and Health Administration develops workplace exposure standards known as Permissible Exposure Limits (PELs). They are OSHA-derived legal occupational exposure standards usually averaged over a normal 8-hour workday.