13.1 International and national regulatory frameworks
4 min read•august 7, 2024
International and national regulatory frameworks play a crucial role in protecting our environment and health. These frameworks, like the Stockholm Convention and REACH, set guidelines for managing hazardous chemicals and waste globally. They aim to reduce pollution, control toxic substances, and promote safer alternatives.
In the U.S., laws like the Clean Water Act and TSCA regulate pollutants and chemicals. The EPA enforces these rules, while in Europe, ECHA oversees chemical safety. These agencies work to balance environmental protection with economic interests, ensuring a safer world for all.
International Conventions
Stockholm Convention
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- Global treaty aimed at protecting human health and the environment from persistent organic pollutants (POPs)
- Requires parties to take measures to eliminate or reduce the release of POPs into the environment
- Targets chemicals that are toxic, persist in the environment, bioaccumulate through the food web, and pose a risk of causing adverse effects to human health and the environment
- Includes provisions for the production, import, export, disposal, and use of POPs
- Lists 12 initial POPs, including pesticides (DDT), industrial chemicals (PCBs), and unintentional by-products (dioxins and furans)
Basel Convention
- International treaty designed to reduce the movements of hazardous waste between nations, specifically from developed to less developed countries
- Aims to minimize the amount and toxicity of wastes generated and ensure their environmentally sound management
- Establishes a regulatory system for the transboundary movement of hazardous wastes and other wastes
- Requires prior informed consent from the importing country before hazardous waste can be exported
- Encourages the treatment and disposal of hazardous wastes as close as possible to their source of generation
REACH (Registration, Evaluation, Authorization and Restriction of Chemicals)
- European Union regulation for managing the risks associated with chemicals
- Requires companies to register chemicals they manufacture or import into the EU above one tonne per year
- Evaluates the hazards and risks of chemicals, and implements necessary restrictions or bans
- Places the burden of proof on companies to demonstrate the safety of their chemicals
- Aims to protect human health and the environment while enhancing the competitiveness of the EU chemicals industry
- Encourages the replacement of hazardous chemicals with safer alternatives
U.S. Environmental Legislation
Water and Air Quality Regulations
- Clean Water Act regulates discharges of pollutants into waters of the United States and sets quality standards for surface waters
- Establishes the permit program for point source discharges
- Requires states to develop for impaired water bodies
- regulates air emissions from stationary and mobile sources to protect public health and welfare
- Sets for six criteria pollutants (carbon monoxide, lead, nitrogen dioxide, ozone, particulate matter, and sulfur dioxide)
- Requires states to develop to achieve and maintain NAAQS
- Establishes the and for industrial sources
Chemical and Pesticide Regulations
- TSCA (Toxic Substances Control Act) provides EPA with authority to require reporting, record-keeping, and testing of chemicals, and to restrict the production and use of chemicals that pose unreasonable risks
- Requires manufacturers to submit pre-manufacture notices (PMNs) for new chemicals
- Grants EPA the authority to ban or restrict chemicals that pose an unreasonable risk to health or the environment
- regulates the registration, distribution, sale, and use of pesticides
- Requires all pesticides sold or distributed in the United States to be registered with the EPA
- Establishes a risk-benefit standard for pesticide registration, considering both the risks and benefits of pesticide use
- Mandates the proper labeling of pesticides and the use of personal protective equipment for applicators
Regulatory Agencies
EPA (Environmental Protection Agency)
- Federal agency responsible for protecting human health and the environment in the United States
- Develops and enforces regulations based on laws passed by Congress
- Conducts environmental assessments, monitoring, and research
- Provides grants for environmental projects, education, and research
- Collaborates with other federal, state, and local agencies to address environmental issues
- Oversees the implementation of major environmental laws, such as the Clean Air Act, Clean Water Act, and TSCA
ECHA (European Chemicals Agency)
- Agency of the European Union that manages the technical, scientific, and administrative aspects of the REACH regulation
- Coordinates the evaluation and authorization processes for chemicals under REACH
- Maintains a public database of chemical information submitted by companies under REACH
- Provides guidance and assistance to companies, particularly small and medium-sized enterprises, in complying with REACH requirements
- Cooperates with international organizations and third countries to promote the safe use of chemicals globally
- Contributes to the development and implementation of EU policies and legislation related to chemicals
Key Terms to Review (17)
Basel Convention: The Basel Convention is an international treaty designed to reduce the movement of hazardous waste between countries, particularly from developed to developing nations. It emphasizes the importance of environmentally sound management of waste and aims to protect human health and the environment by controlling and minimizing hazardous waste production and disposal.
Bioassays: Bioassays are scientific tests that use living organisms to assess the effects of various substances, such as chemicals or pollutants, on biological systems. These tests help determine toxicity levels and the potential impact of contaminants on ecosystems and human health. Bioassays can be used to study both acute and chronic exposure effects, evaluate different types of pollutants, and support regulatory decisions regarding environmental safety.
Clean Air Act: The Clean Air Act is a comprehensive federal law in the United States designed to control air pollution on a national level. It authorizes the Environmental Protection Agency (EPA) to establish and enforce air quality standards, regulate emissions of hazardous air pollutants, and oversee state implementation plans to improve air quality, reflecting a commitment to protecting public health and the environment.
Environmental Protection Agency (EPA): The Environmental Protection Agency (EPA) is a U.S. federal agency established in 1970, responsible for protecting human health and the environment through regulations and enforcement of environmental laws. The EPA plays a crucial role in setting standards for air and water quality, managing hazardous waste, and overseeing the cleanup of contaminated sites, which are essential components of national regulatory frameworks. Additionally, the agency utilizes various monitoring techniques and programs to track environmental contaminants and ensure compliance with established regulations.
Environmental Risk Assessment: Environmental risk assessment is a systematic process that evaluates the potential adverse effects of human activities or natural events on the environment and human health. It involves identifying hazards, assessing exposure, and characterizing risks, which helps inform regulatory frameworks and management strategies to protect ecosystems and public health.
European Chemicals Agency (ECHA): The European Chemicals Agency (ECHA) is an agency of the European Union responsible for the implementation of the EU's chemicals legislation, including the registration, evaluation, authorization, and restriction of chemical substances. ECHA plays a crucial role in protecting human health and the environment from hazardous chemicals while promoting the competitiveness of the EU chemicals industry through scientific assessments and risk management strategies.
FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act): FIFRA is a United States federal law enacted in 1947 that governs the registration, distribution, sale, and use of pesticides. It aims to protect human health and the environment by ensuring that pesticide products are safe and effective when used according to label instructions. The act establishes a regulatory framework for pesticide approval, monitoring, and enforcement at both the federal and state levels.
Hazard classification: Hazard classification is the systematic process of identifying and categorizing substances, mixtures, or activities based on their potential to cause harm to human health or the environment. This classification is crucial for developing safety regulations, labeling requirements, and risk management strategies in various contexts, especially in regulatory frameworks that guide the handling and use of hazardous materials.
National Ambient Air Quality Standards (NAAQS): National Ambient Air Quality Standards (NAAQS) are regulations established by the Environmental Protection Agency (EPA) under the Clean Air Act that set limits on specific air pollutants to protect public health and the environment. These standards are designed to ensure that air quality remains safe for all citizens, particularly vulnerable populations, and they guide state and local governments in implementing measures to reduce air pollution. NAAQS play a crucial role in managing air quality on a national scale and are fundamental to broader regulatory frameworks concerning environmental protection.
National Emission Standards for Hazardous Air Pollutants (NESHAPs): NESHAPs are regulatory standards established under the Clean Air Act aimed at limiting emissions of hazardous air pollutants from specific industrial sources. These standards are critical in protecting public health and the environment by ensuring that air quality meets safe levels, particularly in areas where vulnerable populations may be exposed to toxic emissions.
National Pollutant Discharge Elimination System (NPDES): The National Pollutant Discharge Elimination System (NPDES) is a program established under the Clean Water Act that regulates the discharge of pollutants into U.S. waters. It aims to protect water quality by requiring permits for any point source discharges, ensuring that pollutants are managed and reduced. The NPDES is essential for maintaining compliance with water quality standards and is a key part of the regulatory framework that governs water pollution control.
New Source Performance Standards (NSPS): New Source Performance Standards (NSPS) are regulatory standards established by the Environmental Protection Agency (EPA) to control emissions from new or modified industrial facilities. These standards aim to set a baseline for pollution control technology and practices, ensuring that new sources of air and water pollutants meet specific performance criteria to minimize environmental impact and protect public health.
Polluter Pays Principle: The polluter pays principle is an environmental policy concept where the costs associated with pollution are borne by the polluter rather than society at large. This principle encourages responsible environmental practices by making it economically beneficial for businesses to reduce pollution, as they are directly accountable for the damages they cause. It serves as a foundation for various international and national regulatory frameworks aimed at environmental protection and sustainable development.
Precautionary Principle: The precautionary principle is an approach to environmental management that advocates taking preventive action in the face of uncertainty. It emphasizes that the burden of proof regarding potential harm falls on those proposing an action, rather than those opposing it. This principle is crucial in shaping regulatory frameworks and guiding risk management strategies, ensuring that environmental and public health are prioritized when scientific evidence is inconclusive.
State Implementation Plans (SIPs): State Implementation Plans (SIPs) are comprehensive plans developed by individual states to demonstrate how they will achieve and maintain national air quality standards set by the Environmental Protection Agency (EPA). These plans outline specific strategies and measures that each state will implement to control air pollution and protect public health, connecting state-level actions with federal regulations and standards.
Substance Registration: Substance registration refers to the process by which chemical substances are documented and assessed for safety, environmental impact, and regulatory compliance before they can be manufactured or used commercially. This process is crucial for ensuring that substances do not pose significant risks to human health or the environment, and it involves gathering data on the substance’s properties, uses, and potential hazards, as well as requiring manufacturers to provide detailed information to regulatory authorities.
Total Maximum Daily Loads (TMDLs): Total Maximum Daily Loads (TMDLs) are regulatory limits established to determine the maximum amount of a pollutant that a waterbody can receive while still meeting water quality standards. TMDLs are essential for restoring and protecting the health of aquatic ecosystems by ensuring that the cumulative impacts of pollution from various sources do not exceed the established thresholds. They play a critical role in managing water quality and are often part of broader efforts under regulatory frameworks to address environmental concerns.