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4.6: Regulatory Agencies and Compliance

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    Authors: Jayshree Mahajan, Bradley Anderson, Aaron Bennick, Michael Salciccioli
    Stewards: Jocelyn Anleitner, Stephanie Combs, Diane Feldkamp, Heeral Sheth


    Regulatory agencies govern various sections of chemical plants from emissions and water treatment to personnel behaviors and company policy. Understanding of the types of organizations that demand high performance from chemical plants on a national and local level are extremely important for the safety of the employees, community and environment.

    Regulatory Compliance

    Compliance is an integral part of ensuring the safety of all that work in close contact with the chemical plant as well as minimizing fines and fees that come with violating regulations. Compliance can be organized into two main categories; plant safety and environmental safety. Plant safety ensures employees and the surrounding community are adequately protected during full-operation of the plant. Environmental safety comprises protecting and treating the environmental carefully when it comes to various contaminated streams in the plant.

    Plant Safety for Employees and the Community

    Safety is paramount in any chemical process, and alarms are essential for compliance with safety constraints. OSHA has established guidelines that must be followed in any plant when dealing with chemicals defined as highly hazardous. Limits for temperature, pressure, flow rates, and compositions need to be regulated. Alarms should be in place to warn operators when a limit is near so that steps can be taken to ensure the safety of people in the plant. An example of this is a safe temperature limit for a CSTR. The alarm signals that the temperature is too high and action is needed to prevent a runaway scenario. If the corrective action is not taken, or not taken quickly enough, a critical alarm can signal a computer program to automatically shut down the entire process or specific unit operation.

    Some industries may expect product quality to be closely regulated by the FDA or other government agencies. Typically, this will be in a process where the final product is directly used by people and the margins for error are small. These processes include food processing and manufacturing consumer products, especially pharmaceuticals. These industries usually require systems in place that frequently validate alarms, as well as documentation for all critical alarm events. Measurements such as the weight percent of a pharmaceutically active compound in a solution must be carefully monitored, with recorded uncertainty analysis.

    Environmental Safety

    Emissions of solids, liquids, and gases in a plant are heavily regulated by government agencies. Regulations apply for processes that emit chemicals to the atmosphere (either directly or following a scrubber), processes that discharge material into a body of water, or processes that require containment control devices like check valves and rupture disks. Alarms are frequently used to comply with these regulations by measuring things such as pH and organic solvent concentration. Typically, a warning alarm will alert personnel that a threshold may be breached if action is not taken, allowing time to avoid an incident requiring a formal report. Critical alarms can alert operators that a threshold has been passed and automatically trigger the appropriate action, such as a systematic shutdown of the process.

    Regulatory Agencies

    Federal and national agencies maintain smaller state subsections of various programs and administrations. In most cases, the state level requires stricter compliance and lower limits. Solely state-controlled programs usually handle the air and water quality since any regulation violation results in the consequences for the immediate community.

    Federal and National Agencies or Programs

    Plant safety and environmental safety programs regulated on the national or federal level are monitored by three main agencies; the Environmental Protection Agency (EPA), the U.S. Department of Labor, the Food and Drug Administration, and the Department of Homeland Security. These three governing bodies have created numerous acts, committees, administrations and policies that protect the welfare of the employee, community, and environment.

    The EPA at the federal level, provides acts, laws, and regulations, that help maintain and improve the air and water quality. The risk management program (RMP) is a mandatory program that "require facilities that produce, handle, process, distribute, or store certain chemicals to develop a Risk Management Program". A Risk Management Plan (RMP) must be submitted to the EPA for approval. Overall, risk management is a large part of process control as control systems must adequately function and maintain compliance of an entire facility. Failure logic for instrumentation, redundant sensors, and critical alarms are essential in maintaining compliance, but a RMP is crucial for handling low-likelihood emergency situations.

    The U.S. Department of Labor maintains the Occupational Safety and Health Administration (OSHA) which provides rules and regulations for employers and employees on safe workplace practices. Although individual states may maintain their own occupational health and safety plans, OSHA is the governing body and authority on those programs. Inspections are performed to ensure that all employees have a clean and safe working environment that is hazard-free and risk-mediated. OSHA also maintains the Process Safety Management Program (PSM) which regulates requirements for facilities that handle highly hazardous chemicals. A list of chemicals that qualify include chlorine, formaldehyde, and hydroflouric acid. Requirements of PSM include frequent process hazard analysis (PHA), pre-startup safety review (PSSR), and incident investigations. A cooperative program that OSHA maintains is The Voluntary Protection Programs (VPP). These programs aim to bring together management and labor to provide comprehensive safety and health guidelines and regulations that keep all employees safe while on the job. Each facility must submit application for entry into the program and upon acceptance will follow a set of standards to ensure continued safety. The following is a detailed description of why PSM should be important to chemical engineers, and also some highlights of the main aspects of PSM as required by OSHA.

    Process Safety Management (PSM) -- Why is this important to chemical engineers?

    See the following links to videos provided by the United States Chemical Safety Board describing a few catastrophic events that have occurred in the chemical engineering industry:

    • 2005 Texas City Refinery Explosion
    • Bhopal Disaster

    Besides the catastrophic nature of events that can occur from neglecting Process Safety, large chemical facilities are granted a privilege and license to operate by the different federal regulatory agencies. If these regulatory agencies perform an audit on a specific facility, and find that their regulations are not being followed, then extremely large fines can be levied to the company, even to the extent of shutting the facility down permanently by removing that facility's privilege to operate. In the case of PSM, it is OSHA who deals out these fines. For example, in 2009 OSHA attempted to levy a record 87 million dollar fine to an integrated oil company, which has not been finalized in the legal system yet, but gives a good example of how important it is for companies operating in the U.S., if they want to continue to operate safely and economically, to follow all government regulations as closely as possible.

    Unexpected releases of toxic, reactive, or flammable liquids and gases in processes involving highly hazardous chemicals have been reported for many years in various industries that use chemicals with such properties. Regardless of the industry that uses these highly hazardous chemicals, there is a potential for an accidental release any time they are not properly controlled, creating the possibility of disaster. As a result of catastrophic incidents in the past, and to help ensure safe and healthful workplaces, OSHA has issued the Process Safety Management of Highly Hazardous Chemicals standard (29 CFR 1910.119), which contains requirements for the management of hazards associated with processes using highly hazardous chemicals. OSHA’s standard 29CFR 1910.119 emphasizes the management of hazards associated with highly hazardous chemicals and establishes a comprehensive management program that integrates technologies, procedures, and management practices. A detailed list of these standards can be found on the United States Department of Labor website: An effective process safety management program requires a systematic approach to evaluating the whole process. Using this approach the process design, process technology, operational and maintenance activities and procedures, training programs, and other elements which impact the process are all considered in the evaluation. Process safety management is the proactive identification, evaluation and mitigation or prevention of chemical releases that could occur as a result of failures in process, procedures or equipment. OSHA prescribes essential tools to the success of process safety management including:

    • Process Safety Information
    • Process Hazard Analysis
    • Operating Procedures and Practices
    • Employee Training
    • Pre-Startup Safety Review
    • Mechanical Integrity
    • Management of Change
    • Incident Investigation
    • Emergency Preparedness
    • Compliance Audits

    The thought is, with the simultaneous implementation of all of these things at a facility dealing with large amounts of highly hazardous chemicals, the risk of a catastrophic incident resulting from an unplanned release will be minimized. Following is a detailed discussion of each of these tools prescribed by OSHA.

    Process Safety Information (PSI)

    Complete, accurate, and up-to-date written information concerning process chemicals, process technology, and process equipment is essential to an effective process safety management program. The compiled information will be a necessary resource to a variety of users including the team that will perform the process hazards analysis, those developing the training programs and operating procedures, contractors whose employees will be working with the process, those conducting the pre-startup safety reviews, local emergency preparedness planners, and insurance and enforcement officials. PSI includes, but is not limited to:

    • Material and safety data sheets (MSDS)
    • A block flow diagram showing the major process equipment and interconnecting process flow lines
    • Process Flow Diagrams (PFDs)
    • Piping and Instrument Diagrams (P&IDs)
    • Process design information, including the codes and standards relied on to establish good engineering design

    Process Hazards Analysis (PHA)

    A process hazards analysis (PHA) is one of the most important elements of the process safety management program. A PHA is an organized and systematic effort to identify and analyze the significance of potential hazards associated with the processing and handling of highly hazardous chemicals. A PHA is directed toward analyzing potential causes and consequences of fires, explosions, releases of toxic or flammable chemicals, and major spills of hazardous chemicals. The PHA focuses on equipment, instrumentation, utilities, human actions, and external factors that might impact the process. These considerations assist in determining the hazards and potential failure points or failure modes in a process.

    A team from each process unit in the facility will be tasked with conducting a PHA for their process unit at regularly scheduled intervals as defined by OSHA. One example is in an oil refinery, where a PHA has to be conducted and documented for each process unit every five calendar years. The competence of the team conducting the PHA is very important to its success. A PHA team can vary in size from two people to a number of people with varied operational and technical backgrounds. The team leader needs to be fully knowledgeable in the proper implementation of the PHA methodology that is to be used and should be impartial in the evaluation. The other full or part time team members need to provide the team with expertise in areas such as process technology, process design, operating procedures and practices, alarms, emergency procedures, instrumentation, maintenance procedures, safety and health, and any other relevant subject as the need dictates. The ideal team will have an intimate knowledge of the standards, codes, specifications and regulations applicable to the process being studied.

    There are various methodologies for conducting a PHA. Choosing which one is right for each individual facility will be influenced by many factors, including the amount of existing knowledge about the process. For more information on the different methodologies for conducting a PHA, see Center for Chemical Process Safety of the American Institute of Chemical Engineers

    Operating Procedures

    Operating procedures provide specific instructions or details on what steps are to be taken or followed in carrying out the task at hand. The specific instructions should include the applicable safety precautions and appropriate information on safety implications. For example, the operating procedures addressing operating parameters will contain operating instructions about pressure limits, temperature ranges, flow rates, what to do when an upset condition occurs, what alarms and instruments are pertinent if an upset condition occurs, and other subjects. Another example of using operating instructions to properly implement operating procedures is in starting up or shutting down the process.

    Operating procedures and instructions are important for training operating personnel. The operating procedures are often viewed as the standard operating practices (SOPs) for operations. Control room personnel and operating staff, in general, need to have a full understanding of operating procedures. In addition, operating procedures need to be changed when there is a change in the process. The consequences of operating procedure changes need to be fully evaluated and the information conveyed to the personnel. For example, mechanical changes to the process made by the maintenance department (like changing a valve from steel to brass or other subtle changes) need to be evaluated to determine whether operating procedures and practices also need to be changed. All management of change actions must be coordinated and integrated with current operating procedures, and operating personnel must be alerted to the changes in procedures before the change is made. When the process is shut down to make a change, the operating procedures must be updated before re-starting the process.

    Employee Training

    All employees, including maintenance and contractor employees involved with highly hazardous chemicals, need to fully understand the safety and health hazards of the chemicals and processes they work with so they can protect themselves, their fellow employees, and the citizens of nearby communities. Training conducted in compliance with the OSHA Hazard Communication standard (Title 29 Code of Federal Regulations (CFR) Part 1910.1200) will inform employees about the chemicals they work with and familiarize them with reading and understanding MSDSs. However, additional training in subjects such as operating procedures and safe work practices, emergency evacuation and response, safety procedures, routine and non-routine work authorization activities, and other areas pertinent to process safety and health need to be covered by the employer's training program.

    In establishing their training programs, employers must clearly identify the employees to be trained, the subjects to be covered, and the goals and objectives they wish to achieve. The learning goals or objectives should be written in clear measurable terms before the training begins. These goals and objectives need to be tailored to each of the specific training modules or segments. Employers should describe the important actions and conditions under which the employee will demonstrate competence or knowledge as well as what is acceptable performance.

    Careful consideration must be given to ensure that employees, including maintenance and contract employees, receive current and updated training. For example, if changes are made to a process, affected employees must be trained in the changes and understand the effects of the changes on their job tasks. Additionally, as already discussed, the evaluation of the employee's absorption of training will certainly determine the need for further training.

    Pre-Startup Safety Review

    For new processes, the employer will find a PHA helpful in improving the design and construction of the process from a reliability and quality point of view. The safe operation of the new process is enhanced by making use of the PHA recommendations before final installations are completed. P&IDs should be completed, the operating procedures put in place, and the operating staff trained to run the process, before startup. The initial startup procedures and normal operating procedures must be fully evaluated as part of the pre-startup review to ensure a safe transfer into the normal operating mode.

    For existing processes that have been shut down for turnaround or modification, the employer must ensure that any changes other than "replacement in kind" made to the process during shutdown go through the management of change procedures. P&IDs will need to be updated, as necessary, as well as operating procedures and instructions. If the changes made to the process during shutdown are significant and affect the training program, then operating personnel as well as employees engaged in routine and non-routine work in the process area may need some refresher or additional training. Any incident investigation recommendations, compliance audits, or PHA recommendations need to be reviewed to see what affect they may have on the process before beginning the startup.

    Mechanical Integrity

    Employers must review their maintenance programs and schedules to see if there are areas where "breakdown" is used rather than the more preferable on-going mechanical integrity program. Equipment used to process, store, or handle highly hazardous chemicals has to be designed, constructed, installed, and maintained to minimize the risk of releases of such chemicals. This requires that a mechanical integrity program be in place to ensure the continued integrity of process equipment.

    Elements of a mechanical integrity program include identifying and categorizing equipment and instrumentation, inspections and tests and their frequency; maintenance procedures; training of maintenance personnel; criteria for acceptable test results; documentation of test and inspection results; and documentation of manufacturer recommendations for equipment and instrumentation.

    Management of Change

    To properly manage changes to process chemicals, technology, equipment and facilities, one must define what is meant by change. In the process safety management standard, change includes all modifications to equipment, procedures, raw materials, and processing conditions other than "replacement in kind." These changes must be properly managed by identifying and reviewing them prior to implementing them. For example, the operating procedures contain the operating parameters (pressure limits, temperature ranges, flow rates, etc.) and the importance of operating within these limits. While the operator must have the flexibility to maintain safe operation within the established parameters, any operation outside of these parameters requires review and approval by a written management of change procedure. Management of change also covers changes in process technology and changes to equipment and instrumentation. Changes in process technology can result from changes in production rates, raw materials, experimentation, equipment unavailability, new equipment, new product development, change in catalysts, and changes in operating conditions to improve yield or quality. Equipment changes can be in materials of construction, equipment specifications, piping pre-arrangements, experimental equipment, computer program revisions, and alarms and interlocks. Employers must establish means and methods to detect both technical and mechanical changes.

    Temporary changes have caused a number of catastrophes over the years, and employers must establish ways to detect both temporary and permanent changes. It is important that a time limit for temporary changes be established and monitored since otherwise, without control, these changes may tend to become permanent. Temporary changes are subject to the management of change provisions. In addition, the management of change procedures are used to ensure that the equipment and procedures are returned to their original or designed conditions at the end of the temporary change. Proper documentation and review of these changes are invaluable in ensuring that safety and health considerations are incorporated into operating procedures and processes. Employers may wish to develop a form or clearance sheet to facilitate the processing of changes through the management of change procedures. A typical change form may include a description and the purpose of the change, the technical basis for the change, safety and health considerations, documentation of changes for the operating procedures, maintenance procedures, inspection and testing, P&IDs, electrical classification, training and communications, pre-startup inspection, duration (if a temporary change), approvals, and authorization. Where the impact of the change is minor and well understood, a check list reviewed by an authorized person, with proper communication to others who are affected, may suffice. For a more complex or significant design change, however, a hazard evaluation procedure with approvals by operations, maintenance, and safety departments may be appropriate. Changes in documents such as P&IDs, raw materials, operating procedures, mechanical integrity programs, and electrical classifications should be noted so that these revisions can be made permanent when the drawings and procedure manuals are updated. Copies of process changes must be kept in an accessible location to ensure that design changes are available to operating personnel as well as to PHA team members when a PHA is being prepared or being updated.

    Incident Investigation

    Incident investigation is the process of identifying the underlying causes of incidents and implementing steps to prevent similar events from occurring. The intent of an incident investigation is for employers to learn from past experiences and thus avoid repeating past mistakes. The incidents OSHA expects employers to recognize and to investigate are the types of events that resulted in or could reasonably have resulted in a catastrophic release. These events are sometimes referred to as "near misses," meaning that a serious consequence did not occur, but could have.

    Employers must develop in-house capability to investigate incidents that occur in their facilities. A team should be assembled by the employer and trained in the techniques of investigation including how to conduct interviews of witnesses, assemble needed documentation, and write reports. A multi-disciplinary team is better able to gather the facts of the event and to analyze them and develop plausible scenarios as to what happened, and why. Team members should be selected on the basis of their training, knowledge and ability to contribute to a team effort to fully investigate the incident.

    Emergency Preparedness

    Each employer must address what actions employees are to take when there is an unwanted release of highly hazardous chemicals. Emergency preparedness is the employer's third line of defense that will be relied on along with the second line of defense, which is to control the release of chemical. Control releases and emergency preparedness will take place when the first line of defense to operate and maintain the process and contain the chemicals fails to stop the release.

    Employers will need to select how many different emergency preparedness or third lines of defense they plan to have, develop the necessary emergency plans and procedures, appropriately train employees in their emergency duties and responsibilities, and then implement these lines of defense. Employers, at a minimum, must have an emergency action plan that will facilitate the prompt evacuation of employees when there is an unwanted release of a highly hazardous chemical. This means that the employer's plan will be activated by an alarm system to alert employees when to evacuate, and that employees who are physically impaired will have the necessary support and assistance to get them to a safe zone. The intent of these requirements is to alert and move employees quickly to a safe zone. Delaying alarms or confusing alarms are to be avoided. The use of process control centers or buildings as safe areas is discouraged. Recent catastrophes indicate that lives are lost in these structures because of their location and because they are not necessarily designed to withstand overpressures from shock waves resulting from explosions in the process area.

    Preplanning for more serious releases is an important element in the employer's line of defense. When a serious release of a highly hazardous chemical occurs, the employer, through preplanning, will have determined in advance what actions employees are to take. The evacuation of the immediate release area and other areas, as necessary, would be accomplished under the emergency action plan. If the employer wishes to use plant personnel-such as a fire brigade, spill control team, a hazardous materials team-or employees to render aid to those in the immediate release area and to control or mitigate the incident, refer to OSHA's Hazardous Waste Operations and Emergency Response (HAZWOPER) standard (Title 79 CFR Part 1910.1 20). If outside assistance is necessary, such as through mutual aid agreements between employers and local government emergency response organizations, these emergency responders are also covered by HAZWOPER. The safety and health protection required for emergency responders is the responsibility of their employers and of the on-scene incident commander.

    Compliance Audits

    An audit is a technique used to gather sufficient facts and information, including statistical information, to verify compliance with standards. Employers must select a trained individual or assemble a trained team to audit the process safety management system and program. A small process or plant may need only one knowledgeable person to conduct an audit. The audit includes an evaluation of the design and effectiveness of the process safety management system and a field inspection of the safety and health conditions and practices to verify that the employer's systems are effectively implemented. The audit should be conducted or led by a person knowledgeable in audit techniques who is impartial towards the facility or area being audited. The essential elements of an audit program include planning, staffing, conducting the audit, evaluating hazards and deficiencies and taking corrective action, performing a follow-up review, and documenting actions taken.

    Other Federal Entities

    The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA regulates food, drugs, cosmetics, biologics, medical devices, radiation-emitting devices and vetenary products manufactured in the United States. The main goal of the FDA is to maitain that the products they regulate are safe, effective, and secure. The FDA is also responsible that the products are accurately represented to the public. State and local governments also help regulate these products in cooperation with the FDA. The FDA does not regulate alcohol, illegal drugs, and meat and poultry.

    The Department of Homeland Security has recently taken a role in regulating chemical plants because of 9/11. Chemical plants are seen by the government as targets for terrorists and security in and around the plant is a major concern. Although the laws are typically state run, the Department of Homeland Security has required mandatory national security standard to chemical plants throughout the nation. Although the mandates were fought by legislative for years, the Department of Homeland Security has influence in the security in chemical plants. The law requires the plant to prepare a vulnerability test and submit a site security plan. In order to validate these activities, audits and site visits are/will be performed by government officials.

    State Regulations

    State regulations vary greatly from state-to-state depending on the main concern. For instance, beach quality is more important in California than Nebraska due to the geographical location. Similarly state legislative acts and administrations can expect high performance from the chemical industry as it has the capability to affect all parts of a community for many generations.


    • U.S. National Profile on the Management of Chemicals.
    • U.S. Department of Labor. Occupational Safety & Health Administration. Process Safety Management.
    • U.S. Department of Labor. Occupational Safety & Health Administration. State Occupational Health and Safety Plans.
    • U.S. Department of Labor. Voluntary Protection Programs.
    • Environmental Protection Agency. Regulatory Information by Business Sector.
    • Environmental Protection Agency. Regulatory Information by Environmental Topic.
    • Environmental Protection Agency. State Specific Regulatory Information Search Engine.
    • Environmental Protection Agency. Risk Management Plan.
    • United States Chemical Safety and Hazard Regulation Board. Homepage.
    • U.S. Department of Health & Human Services. Food and Drug Administration.
    • United States Chemical Safety Board (CSB).
    • Center for Chemical Process Safety (CCPS).

    This page titled 4.6: Regulatory Agencies and Compliance is shared under a CC BY 3.0 license and was authored, remixed, and/or curated by Peter Woolf et al. via source content that was edited to the style and standards of the LibreTexts platform; a detailed edit history is available upon request.