Chemical compliance in the US
01 Jun 2024
Ensuring access to the US market requires a comprehensive understanding of the Federal and State specific chemical Regulations, Acts and Standards. As legislators introduce further regulations and enforcement measures for non-compliance in their continued efforts to protect human and environmental health, organizations can minimize future risk and ensure customer satisfaction by maintaining compliance.
Failure to comply with these regulations can result in enforcement measures such as goods being stopped at borders, penalties, fines, and even criminal prosecution.
Not all regulations apply to all chemicals, substances or mixtures, and it can be complex to identify which regulations apply as this can depend on the intended use of the chemical and the state in which it is sold. Some substances are banned, while others have usage limits or reporting and testing requirements.
Regulatory bodies | Key legislation | Other legislation | State based regulations | Solutions for your business
Regulatory Bodies
There are several regulatory bodies within the US with responsibility to public and environmental safety and health.
EPA: Environmental Protection Agency
Focuses on the protection of human health and the environment by writing and enforcing policy. As part of their mission, EPA ensures that there is clean air, land, and water and that contaminated lands are cleaned up by the responsible people. It further ensures that commercial chemicals are regulated, and clear and accurate safety information is easily accessible to all.
OSHA: Occupational Health and Safety Administration
Created to ensure safe and healthy working conditions by providing training and setting safety standards. OSHA is a subsidiary of the United States Department of Labor, it enforces standards by implementing outreach, education, and assistance programs.
Food and Drug Administration (FDA)
The US federal department responsible for protecting and promoting public health, inspecting and reviewing production facilities for regulated products, approving regulated products before they can be sold in the U.S, and recalling products from the market if necessary for safety reasons. The FDA does this through the control and supervision of various products, including food safety, tobacco, dietary supplements, medicine, medical devices, and cosmetics.
Consumer Product Safety Commission
The CPSC is the federal agency responsible for ensuring the safety of consumer products. They regulate the sale of all consumer products, except for those covered by other legislation such as cosmetics, tobacco, etc. The CPSC issues standards and can recall and even ban products that are considered to be unsafe and unable to meet standards. It also researches potential product hazards and informed and educates consumers.
Department of Transportation
The DoT regulates the transport of dangerous goods within the US through one of its agencies, the Pipeline and Hazardous Materials Safety Administration (PHMSA). They are responsible for the development of standards covering all modes of domestic transport.
Key legislation
There are many US Federal Acts and Standards in place to ensure the safe use, transportation, import and disposal of chemicals. Some of the key pieces of legislation for companies placing chemicals on the US market include:
Toxic Substances Control Act (TSCA)
TSCA ensures new and existing chemicals are used, stored, imported, and disposed of safely in respect of human health and the environment. TSCA gives the Environmental Protection Agency (EPA) authority to regulate chemicals by requiring industry reporting, record-keeping, and testing. Based on this information, EPA then regulates the manufacture, importation, processing, distribution, use, and disposal of any chemical that presents an unreasonable risk of injury to human health or the environment. The Act includes specific measures for substances such as PCBs, asbestos, radon and lead. These measures range in severity and may include a total ban on production, import, and use to a requirement that a product bears a warning label at the point of sale. The Act does not regulate food, food packaging, pharmaceuticals, pesticides, and chemicals used in cosmetics and personal care products.
HAZCOM/HCS: Hazard Communication Standard
HazCom is the standard used to ensure effective communication regarding health and safety when working with chemicals in the workplace. The HazCom system aligns with the Globally Harmonised System (GHS) ensuring consistent communication regarding hazardous chemicals, Safety Data Sheets (SDS), and chemical labelling.
Federal Hazardous Substances Act (FHSA)
The FHSA covers products sold to the general public and requires precautionary labelling on containers of hazardous household products to help consumers safely store and use those products, and to give them information about immediate first aid steps to take if an accident happens. The FHSA also allows the CPSC to ban certain products if they are deemed to be so hazardous that the cautionary labelling required by the FHSA is not adequate to protect consumers. The criteria for determining whether a product is hazardous, and the consequent labelling requirements are significantly different to GHS and the Hazcom Standard.
The Federal Hazardous Materials Transportation law
The Federal Hazmat law is the basic statute regulating hazardous materials transportation in the United States. It covers the transportation of hazardous material in intrastate, interstate, and foreign commerce. The Hazardous Materials Regulation (HMR) covers the practical detail of hazardous materials classification, documentation, training and security, packaging requirements and operational rules for domestic transport by aircraft, railcar, vessel, and motor vehicle.
Other relevant legislation
Clean Air Act (CAA)
Designed to prevent air pollution, protect the ozone layer, and promote public health, including those from chemical manufacturing processes, this act gives the Environmental Protection Agency (EPA) the authority to fight environmental pollution.
Clean Water Act (CWA)
Establishes the basic structure for regulating discharges of pollutants into U.S. waters and regulating quality standards for surface waters. The Act makes it unlawful to discharge any pollutant from a point source, such as from chemical manufacturing processes, into navigable waters without a permit.
Resource Conservation and Recovery Act (RCRA)
This act governs the disposal of solid and hazardous waste, including waste from chemical production. RCRA enables the EPA to control hazardous waste from "cradle-to-grave”, including the safe management and cleanup of solid and hazardous waste, and programs that encourage source reduction and beneficial reuse.
The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)
Designed to clean up sites contaminated with hazardous substances, including chemicals. This law introduced a tax for chemical and petroleum industries and provided broad Federal authority to respond directly to releases or threatened releases of hazardous substances that may endanger public health or the environment. Collected taxes, known as the ‘Superfund’, go towards the clean-up of abandoned or uncontrolled hazardous waste sites.
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Regulates the distribution, sale, and use of biocides and pesticides with the aim of protecting users, consumers, and the environment from harmful effects of pesticides. The U.S. Environmental Protection Agency (EPA) is responsible for implementing FIFRA and registering or licensing biocidal and pesticide products.
Emergency Planning and Community Right-to-Know Act (EPCRA)
Requiring industries to report on the storage, use, and release of hazardous substances to federal, state, and local governments to enable local communities to protect public health, safety, and the environment from chemical hazards.
Food Contact Materials
Food contact materials comprise products and packaging intended to come into contact with food or drinks, such as cookware, cutlery, and food containers. The main focus of this regulation is the restrictions of dangerous substances (e.g. heavy metals), but also covers labelling, documentation, and testing requirements for food, food contact materials, cosmetics, drugs, and other products regulated by the FDA. Compliance requires lab testing to verify that the material meets regulations.
State-based regulations
Safe Drinking Water and Toxic Enforcement Act
This Californian law, also known as Proposition 65 or Prop 65, regulates the use of hazardous chemicals in the state. For example, according to Prop 65, chemicals that “are known to the State of California to cause cancer or reproductive toxicity” must be clearly labelled. Currently, the list has over 900 chemicals, and the warning labels can be found on a range of items.
Right-to-know laws
Several US States, including Massachusetts, New Jersey, and Pennsylvania have ‘right-to-know' laws that require employers to identify hazardous chemicals in the workplace and communicate essential information about them through labelling and other means.
Model Toxics in Packaging Legislation
A number of states have adopted the Model Toxics in Packaging Legislation, which restricts several substances in packaging materials, including lead, mercury, cadmium, PFAS and phthalates. It also restricts certain heavy metals when incidentally introduced to 100 ppm.
Restriction of Hazardous Substances (RoHS)
Originally an EU Directive, RoHS sets restrictions on certain heavy metals and chemicals in electronic components. Many US states have implemented similar RoHS restrictions including California, New Jersey, New York, and Illinois, among others, and the restricted substances and scope of the restrictions may vary according to the state. Certain states may also have requirement for registration and reporting of the materials and chemicals used in products and articles sold or used within the state.
Solutions for your business
Maintaining regulatory compliance, best practice and stakeholder confidence can be complex where numerous acts, standards and regulations impact the operations of your organization. Working with an experienced, reliable, and informed partner ensures organizations are notified of any impending changes and provide support in meeting the requirements affecting your organizations and its products.
organizations producing, using, or transporting hazardous materials or chemicals have the responsibility to comply with the numerous regulations in place to ensure the safe use and handling of chemicals, and to maintain access to markets.
Beyond the regulatory requirement, organizations also have a responsibility to maintain the training of their staff to ensure incident preparedness and to provide an adequate and compliant chemical emergency response solution to further mitigate any potential harm to people, environment, assets and reputation.
Ricardo’s expertise in US chemical regulations ensures compliance as well as providing insight into the ever-changing regulatory landscape. Our chemical and sustainability experts support chemical manufacturers and distributors around the world, helping to reduce risk, deliver operational best practice and improve the long-term sustainability of operations, products, and services.
Tailoring our services to the needs of your organization, we ensure compliance with US legislation is maintained at all times and provide pro-active notifications of changes that may impact your organization.
Chemical emergency response
Level 1 chemical emergency response – or telephone emergency response – is a requirement under US regulations and plays a crucial role in developing a competitive, compliant and commercially responsible chemical safety strategy. Failure to meet this requirement will mean that goods are rejected at borders and access to markets is lost. Equally, transports being declined access may incur recovery costs, penalties or fines, disappoint customers, and eventually damage organizational reputations.
Beyond the regulatory requirement, chemical emergency response is a key part of risk management as it enables organizations to be prepared for when an incident occurs, and ensures plans are in place to avoid or minimize the impact on people, environment, assets and reputation. Rapid access to chemical hazard management information ensures incidents have a high chance of being contained before escalating into much harder to resolve, large-scale incidents, reducing unnecessary intervention costs and the negative impact on your reputation from damaging media coverage.
A robust service should provide knowledgeable and informed support to any caller, whether it is a member of the public, a stakeholder or a responding organization where they are required to manage an incident involving chemicals or hazardous materials. It is vital for chemical manufacturers and organizations that use or transport chemicals around the world to safeguard chemical and hazardous products throughout the supply chain.
Having a robust and versatile telephone emergency response partner also supports sustainability reporting by demonstrating the organizations' commitment to protecting the environment, and supports the organizations Corporate Social Responsibility, Environmental, Social and Governance (ESG), responsible Care® and business Continuity obligations.
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Training
Manage your chemical and wider business risks – from emergency response to supply and transport regulations – by relying on our operational training and support. Our dedicated team of highly qualified, experienced chemists and hazardous materials (hazmat) specialists share their knowledge and expertise to support your business. Training packages balance the subjects’ technical requirements and practical application, with tailored modules to suit the specific needs of your organization.
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Safety Data Sheets
Safety Data Sheets (SDS) provide vital information relating to the potential hazards and physiochemical properties of a product to enable safe use, as well as emergency response, transport, and other regulatory information.
Failure to provide sufficient information on an SDS can cause delays in accessing markets, impact supply chains, increase costs, and increase the risk of harm to people, assets, reputation and the environment.
Companies may also lose business from poor quality SDS. Customers receiving non-compliant SDSs may require corrections before progressing with a purchase, and audits may identify inadequate SDSs for action. Customers are likely to opt for companies presenting thorough and up-to-date documentation first time, demonstrating attention to detail and ability to react to regulatory changes.
Compliant SDSs will not only be safer, but also more economically feasible as they reduce the need for corrective actions thereby increasing confidence in those using the SDS.
Safety Data Sheet – the core of compliance
Providing high-quality SDS is essential to maintain regulatory compliance with US federal regulations including the Hazcom Standard, as well as state right-to-know regulations and providing adequate support for emergency response situations. Acting as an essential data point in all these regulatory areas, having compliant and fit-for-purpose SDS is vital for market access into the US.
Our dedicated in-house team have many years of experience in compiling, reviewing, translating, and submitting SDS on behalf of industry leading chemical organizations. Our end-to-end solution enables our customers to achieve compliance across all territories with no subscription required.
Horizon Scanning – Future proofing compliance
Ricardo’s horizon scanning and compliance reporting tool offers a substance inventory check against global regulatory lists, and provides the results in a clear, easy-to-read report enabling organizations to quickly determine the status of their substances.
The risk management process for chemicals and hazardous materials is complex. Understanding the hazards of chemicals is a key part of responsible product stewardship – essential for a sustainable business and for maintaining compliance with global chemical regulations.
Ricardo’s horizon scanning tool identifies the information pertaining to the product portfolio and sends notifications, minimising the likelihood that changes requiring action are missed, as these could result in non-compliance. This protects reputations and safeguards against enforcement actions, supporting organizations to future-proof their product portfolio.
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Environmental chemistry and toxicology
The global sustainability agenda is forcing governments to radically reconsider how we use chemicals, and their impact on human health and the environment.
Ricardo supports businesses in placing, monitoring, and evaluating regulatory tests, providing specialist expertise in developing alternative approaches to standard testing requirements. By working as your outsourced team, we alleviate any environmental concerns while maintaining your bottom line.
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