Introduction to regulatory compliance
in the chemical industry
Regulations set forth by many governing entities provide a complex regulatory landscape for chemical companies. In the U.S. the Environmental Protection Agency (EPA) administers the Toxic Substance Control Act (TSCA) that regulates new and existing chemicals which is key to protecting human health and the environment.
The Occupational Safety and Health Administration (OSHA) sets forth the Hazard Communication Standard (HCS) that focuses on keeping employees safe through chemical awareness and implements the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Companies that manufacture, store, or distribute certain quantities of hazardous chemicals may be required to submit periodic Hazardous Chemical Inventory Forms or Tier I and II report to the EPA under the Emergency Planning and Community Right-to-Know Act (EPCRA).
While these reports may not be federally mandatory, states and municipalities require them for emergency planning activities. These are only a few of the regulations out of many the chemical industry must adhere to. We will discuss these regulations and provide insight into maintaining regulatory compliance.
The TSCA focuses on the production, distribution, importation, use, and disposal of specific chemicals. The TSCA provides authority to the EPA to require a pre-manufacture notice (PMN) for new chemicals before a company begins manufacture so there is an opportunity for new chemicals to be reviewed before entry into the marketplace.
Testing is required by manufacturers, importers, and processors where risks or exposures of concern are found. The EPA can issue Significant New Use Rules (SNURs) when a new use is identified that results in exposures to or release of a substance of concern.
The TSCA also requires companies to conduct Chemical Data Reporting (CDR) which allows the EPA to collect basic exposure-related information including the types, quantities, and use of chemicals that are produced domestically and imported into the U.S. Information is collected every 4 years from manufacturers of certain chemicals when production volumes are 25,000 lbs or greater at a single site.
If the EPA determines a new chemical or new use presents a high risk of injury to human health or the environment, the EPA may limit or prohibit the manufacture, processing, or distribution. To address compliance to the TSCA, the chemical company’s operational and environmental health & safety (EHS) departments will need to work closely together.
OSHA: Hazard communication standard
OSHA’s HCS has two parts that create obligations for employers in the chemical industry. If hazardous chemicals are being used in the workplace, the HCS requires employers to inform employees about the chemical hazards present through training referred to as HAZCOM or hazard communication training.
Companies that are producing and distributing chemicals must follow the requirements of the HCS and where Safety Data Sheets (SDS) and GHS labeling will be key compliance points to consider.
The SDS is a 16-section format that requires information regarding the product identification, composition, first-aid measures, fire-fighting measures, accidental release measures, exposure control, handling and storage, physical and chemical properties, stability and reactivity, toxicology, ecological information, disposal, transport, and regulatory information, and the last revision date.
Chemical companies are required to ensure the SDS data is accurate, up to date, and provide the buyers with an updated SDS and every year the product is purchased. Chemical manufacturers and distributors are required to provide a label that includes a harmonized signal word, pictogram, and hazard statement for the hazard class and category.
EPCRA: Tier I and II reports
Reporting on hazardous and toxic chemicals is required at the state and municipal level to help increase the public’s knowledge and access to information regarding chemicals at local facilities, their use, and releases into the environment.
This collaborative effort between States, communities, and the chemical company can help to improve chemical safety and protect public health and the environment. Tier I reporting requires information on general hazard types and locations of hazardous chemicals that are present at the facility during the previous calendar year.
Tier II reporting requires specific information on the location and amount of hazardous chemicals present at the facility during the previous calendar year. Reports are required to be submitted by March 1 every year to the State Emergency Response Commission (SER), the Local Emergency Planning Committee (LEPC), and the local fire department.
Chemical management: Try integrating environmental health & safety (EHS)
Some of the biggest challenges facing the chemical industry are related to regulations and the management of chemicals. As updates and changes are made to regulations, it is important to have a department keeping track of these changes. The department may be composed of EHS or regulatory compliance professionals. By assigning this department the responsibility of submitting reports will streamline the regulatory compliance process.
How do EHS and compliance departments get their data?
Most of the regulations require data regarding chemical inventory or from some point in the business process. This means data should be captured at all critical points of the supply chain, production, and distribution processes.
By capturing and transferring this data to an Environmental Management System (EMS), means the EHS and/or compliance staff can readily produce reports necessary to maintain compliance. Additionally, all processes should be documented in Standard Operating Procedures (SOPs) and reviewed frequently to ensure compliance with any updated or new regulations.
Start by conducting a comprehensive audit to compare business processes to SOPs and any related regulations. This ensures the company is conducting work in accordance with regulations. Manage inventory by compiling information on all chemicals and hazardous substances your company is handling into a central location like an EMS will support the completion of necessary reports.
By integrating EHS into the business processes, companies can raise the efficiency of chemical management and provide long-term advantages in the areas of cost savings, safety, and risk management.