Domain 4: Regulatory Compliance Flashcards
What are the four basic steps of regulatory surveillance?
Domain 4:401
Monitor, assess, communicate, and respond
Prof practices p. 308
Define “completeness” in the context of data records.
Domain 4:402
“Completeness” describes the extent to which relevant data records and fields are present and sufficiently populated.
Define “downstream user.”
Domain 4:403
A downstream user is any natural or legal person established within the EEA/EU other than the manufacturer or importer who uses a substance during his/her industrial or professional activities.
What is the purpose of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals?
Domain 4:404
To provide information on physical hazards and toxicity to protect human health and the environment during handling, transport, and the use of these chemicals.
To provide a basis for harmonization of rules and regulations regarding chemicals at the national, regional, and worldwide level.
Which sections are not enforced by OSHA on U.S. SDSs?
Domain 4:405
Sections 12-15
What is the Dodd-Frank Act?
Domain 4:406
The Dodd-Frank Act is legislation concerning disclosure of tin, tungsten, tantalum, or gold and their derivatives to the U.S. Securities and Exchange Commission.
Prof practices p. 267
What does the EU’s Prior Informed Consent Regulation require?
Domain 4:407
Under the EU’s Prior Informed Consent Regulation, 35 days before exporting certain hazardous chemicals and pesticides, the designation national authority must be notified of the intent to export.
Prof practices p. 269
What categories of waste are typically regulated in many countries?
Domain 4:408
Mercury, packaging, electronic products, radioactive materials
Prof practices p. 274-275
What is the primary means of solid waste management in the United States?
Domain 4:409
Landfill disposal
Prof practices p. 271
Packaging legislation typically focuses on phasing out the use of which substances?
Domain 4:410
Mercury, lead, cadmium, hexavalent chromium
Prof practices p. 272
What is the principal source of overarching EU legislation relating to the handling, disposal, and recovery of waste?
Domain 4:411
The Waste Framework Directive, Directive 2008/98/EC
Prof practices p. 276-277
Which two entities regulate non-ionizing radiation in the United States?
Domain 4:412
Federal Communications Commission and Food and Drug Administration
Prof practices p. 279
What is the purpose of the Codex Alimentarius?
Domain 4:413
The Codex Alimentarius serves as the basis for national legislation in many countries to provide access for local goods to international markets and is the benchmark against which national food safety measures and regulations are evaluated within legal parameters.
Prof practices p. 228
Define “consumer products.”
Domain 4:414
Consumer products, also referred to as final goods or household products, are products that are bought by individuals or households for personal use. In other words, consumer products are goods that are bought for consumption by the average person or consumer.
Prof practices p. 253
What does the U.S. Federal Hazardous Substances Act regulate?
Domain 4:415
Consumer products
Prof practices p. 253
What are the Canadian consumer product regulations?
Domain 4:416
The Canada Consumer Product Safety Act (CCPSA) and the Consumer Chemical Container Regulation (CCCR)
Prof practices p. 256
What entity is responsible for the safety of cosmetics in the United States and Canada?
Domain 4:417
The manufacturer
Prof practices p. 257
Why are few personal care products in the United States covered by approved New Drug Applications (NDAs)?
Domain 4:418
The process is time consuming and expensive.
Prof practices p. 258
Define “product liability.”
Domain 4:419
Product liability is the area of tort law in which the seller’s liability derives from a defective product that results in injury or other harm to the purchaser.
Full business value p. 77
Who is typically considered better-positioned than the user to understand the foreseeable risks of harm from using the product, thereby having the duty to warn?
Domain 4:420
Manufacturers/sellers
Full business value p. 83
What is the purpose of U.S. TSCA?
Domain 4:421
TSCA is the general chemical control law in the United States. TSCA provides the U.S. Environmental Protection Agency (EPA) with authority to require reporting, recordkeeping, and testing requirements and restrictions for chemical substances and/or mixtures. Some substances are excluded from TSCA, including food, drugs, cosmetics, and pesticides, among others.
Prof practices p. 202-203
How is a chemical substance defined under U.S. TSCA?
Domain 4:422
A chemical substance is any organic or inorganic substance of a particular molecular identity, in any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, any chemical element, or uncombined radical.
Prof practices p. 202-203
What is the basic process for monitoring emerging issues and assessing impacts?
Domain 4:423
Basic steps in the process include:
Scanning and monitoring.
Identifying the issues.
Prioritizing the response.
Analyzing the issue and its impacts.
Resolving the strategic approach.
Implementing a plan of action.
Evaluating the results of the action.
How was TSCA significantly amended in 2016 when President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LSCA)?
Domain 4:424
The signing of the LCSA provided increased authority for the EPA to regulate chemicals already in commerce that were previously unregulated.
Prof practices p. 202
What is the purpose of EU REACH?
Domain 4:425
This regulation consists of a comprehensive system of regulating the life cycle of chemical substances from manufacture, formulation, and distribution to industrial and consumer use to a certain degree of disposal, recycling, and reuse. REACH impacts all companies in the supply chain of a chemical substance manufactured, imported, sold, and/or used in the EU.
Prof practices p. 205
What do California Proposition 65 Safe Harbor Levels consist of?
Domain 4:426
No significant risk levels (NSRLs) for cancer causing chemicals.
Maximum allowable dose levels (MADLs) for chemicals causing reproductive toxicity.
Prof practices p. 226
Biocidal products include what kinds of products?
Domain 4:427
Insecticides, insect repellents, disinfectants, material preservatives, and anti-fouling paints
What does TSCA Section 4 cover?
Domain 4:428
TSCA Section 4 provides that the EPA can issue rules to require companies to generate hazard and exposure information through specific tests or measurements on chemicals in certain substances.
What does TSCA Section 5 cover?
Domain 4:429
TSCA Section 5 indicates that chemical substances manufactured in or imported into the United States that are not listed on the TSCA inventory and that are not otherwise exempt from TSCA inventory listing are subject to premanufacture notice (PMN) requirements. TSCA Section 5(a) Significant New Use Rules (SNURs) can be used to require notice to the EPA before ither new or existing chemical substances and mixtures are used in new ways that might create concerns.
What does TSCA Section 6 cover?
Domain 4:430
TSCA Section 6 provides for the regulation of existing hazardous chemical substances and mixtures.
What does TSCA Section 8(a) cover?
Domain 4:431
TSCA Section 8(a) requires reporting and recordkeeping by persons who manufacture, import, process, and/or distribute chemical substances in commerce.
What does TSCA Section 8(e) cover?
Domain 4:432
TSCA Section 8(e) requires that any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture present a substantial risk of injury to health or the environment to immediately inform EPA, except where EPA has been adequately informed of such information.
What does TSCA Section 8(c) cover?
Domain 4:433
TSCA Section 8(c) establishes requirements for manufacturers and processors of chemical substance and mixtures to keep records of significant adverse reactions to health and the environment alleged to have been caused by the chemical substance or mixture and to permit inspection and submit copies of records as requested by EPA.
What does TSCA Section 8(d) cover?
Domain 4:434
TSCA Section 8(d) requires any person who manufactures, processes, or distributes in commerce or who proposes to manufacture, process, or distribute in commerce any listed chemical to submit health and safety studies.
What does TSCA Section 12(b) cover?
Domain 4:435
TSCA Section 12(b) outlines export notification requirements for any person who exports or intends to export a chemical substance or mixture subject to certain TSCA regulations.
What does TSCA Section 13 cover?
Domain 4:436
TSCA Section 13 details import certification requirements that must be met before importing a chemical substance, mixture, or article containing a chemical substance or mixture into the United States
