What does EPA’s RMP “General Duty Clause” actually require?

Almost weekly I see and hear the RMP “General Duty Clause” (GDC) being misquoted and improperly applied.  In this article I hope to clarify many of the myths and misconceptions of what EPA actually requires in the application of their GDC’s to RMP chemicals.  First and foremost, there is NO GET OUT OF JAIL FREE CARD when you have a listed PSM or RMP chemical on site, REGARDLESS of quantity.  OSHA refers to these chemicals as Highly Hazardous Chemicals (HHC) and EPA calls them Extremely Hazardous Substances (EHS). Your facility will NEED TO REFER to both OSHA’s standard (1910.119) and EPA’s Rule (112r) as they both have a listing of these chemicals and the two lists are NOT the same.  Your facility may have a chemical that is on OSHA’s list and not on EPA’s list or vice versa. 

One major difference between OSHA and EPA’s lists is Flammable Liquids.  OSHA does NOT list specific flammables, but rather states that if the material has a flash point below 100F, then it is a HHC. EPA’s list will list each of the specific flammables it considers to be an EHS.  But keep this in mind, if you have a flammable liquid on site and you do not exceed the PSM threshold, OSHA will most likely NOT use the PSM standard or general duty clause to enforce safety regarding the flammable liquid, unless of course the quantity exceeds the PSM Threshold Quantity; instead, OSHA will use the Flammable and Combustible Liquids Standard, 1910.106.  EPA will use their GDC if your flammable liquid is BOTH on their list of substances AND the amount on site is below the RMP threshold for that specific flammable.  Now that we have that straighened out, lets look at what EPA requires for those EHS’s that may be present at a facility below it’s RMP threshold.

The general duty clause reflects the U.S. Congressional intent that facilities have the primary responsibility for the prevention of accidents. EPA has jurisdiction to implement and enforce the general duty clause through Sections 113 and 114 of the Clean Air Act at ANY FACILITY where extremely hazardous substances are present.  It applies to “owners and operators of stationary sources producing, processing, handling or storing any extremely hazardous substances.”

EPA’s general duty clause for 112(r) imposes three (3) PRIMARY OBLIGATIONS:

1) Identify hazards which may result from accidental releases using appropriate hazard assessment techniques

2) Design and maintain a safe facility taking such steps as are necessary to prevent releases

3) Minimize the consequences of accidental releases which do occur

NOTE from EPA documents: Substances which causes death or serious injury because of its acute toxic effect or as a result of an explosion or fire or which causes substantial property damage by blast, fire, corrosion or other reaction would create a presumption that such substance is extremely hazardous.” For purposes of complying with the CAA general duty clause, owners and operators must maintain a facility that is free of a hazard, the hazard must be recognized by the owner/operator or recognized by the owner/operator’s industry, the hazard from an accidental release was likely to cause harm, and that the owner/operator could have eliminated or reduced the hazard.

Each of these obligations REQUIRES that a series of measures be taken by the facility; but the general duty clause does NOT prescribe these measures in detail. Basically, we can look at the 112(r) GDC requirements as the same frame work as the actual 112(r) rule without all the requirement details and their required timing.  Each measure is meant to achieve a level of quality, accuracy, and completeness in order to prevent releases and to mitigate any actual releases.

To evaluate compliance with the 112(r) GDC, EPA will assess the extent to which facilities have implemented the following:

1) hazard assessment

2) process design

3) process hazard analysis

4) process maintenance

5) operation

6) mitigation measures

They are going to ensure that these efforts meet or exceed any applicable industry practices or standards, or state or federal regulations. If no industry practice, standard, or regulatory requirement exists for the substance or process, or if the practice or standard is not protective of public health and the environment, facilities are responsible for identifying hazards and taking appropriate measures to prevent releases and minimize the consequences of a release.

EPA provides us with the following example...

in order to prevent a release from a storage vessel, the owners and operators should not only identify the intrinsic hazards of the substance in the vessel, they should also:
1) identify the hazards of the process in which the substance is used
2) design and maintain the process equipment (which includes the vessel) and instrumentation in order to minimize the risk of release
3) identify and implement appropriate equipment/vessel design and maintenance practices, codes, or standards that are relevant to the process and the substance involved
4) operate the process/equipment in a safe manner (e.g., keep volumes, temperatures, pressures, flows, concentrations, pH within specified limits)
5) comply with all applicable state and local regulations; meeting or exceeding the applicable industry practices, codes or standards for that process; and, following all recommended practices of the process equipment manufacturers.
6) be prepared to minimize the effects on the public and the environment if a release should occur by identifying at-risk receptors in the event of the maximum possible release and other probable releases as may be identified in the appropriate hazard analysis/review.
7) the facility’s mitigation activities should include coordination between facility management, employees and the local response agencies

The following describe basic current practices that may be utilized by EPA inspectors to assess compliance with the 112(r) PRIMARY OBLIGATIONS.

1) Has the owner and operator identified hazards which may result from accidental releases?

Facilities are responsible for:

a) determining the INTRINSIC HAZARDS of the chemicals used in the processes,

b) the risks of accidental releases from the processes through possible release scenarios, and

c) the potential effects of these releases on the public and the environment. 

Although the general duty clause does NOT specify how the owner/operator should identify hazards, the hazard assessment, when concluded, should result in the following information:

a) The hazards associated with the EHS and the process,

b) Potential release scenarios developed from site specific hazard analysis/review and facility/industry historical data and

c) the consequences of the release in each case.

The hazards of the substance will include not only the flammability and toxicity of the EHS, but also the process conditions of the specific process. These include:

a) temperature and pressure of processing,

b) human factors, and

c) process siting

A sufficient hazard assessment should include the type, rate and duration of potential releases. Modeling or an applicable dispersion analytical technique should be used to determine the potential impact of the releases. Models or analytical techniques selected for this activity should be appropriate for the material released and the process, atmospheric, and geographic conditions for the particular release scenario. A hazard assessment should also include approximate downwind or down gradient concentrations and how these factors impact the effect of the release on affected populations, systems and environments.

2) Has the owner and operator designed and maintained a safe facility?

EPA considers the requirement to design a safe facility to include construction of a new facility or the design of modifications at existing facilities. EPA inspectors will review the safety information and information gathered in the process hazard analysis (PHA) to assess whether facilities based design considerations upon applicable design codes, federal and state regulations, and recognized industry practices. Inspectors will also assess whether owners and operators had an obligation to exceed these design consideration parameters if the parameters were not adequate to prevent releases or minimize their impacts. The following from EPA provides examples of information sources that inspectors may review to assess whether an owner/operator met its statutory obligation to DESIGN a safe facility:

Codes:
1) Facilities must design the process and the hardware in order to minimize the risks of a release.

2) Facilities must identify, research, and apply design safety codes applicable to the substance and the process.

3) Designs must also consider risks from adjacent processes, which may pose a threat to the process involving extremely hazardous substances, even if the adjacent processes do not involve extremely hazardous substances themselves.

4) Facilities must update equipment to current codes and standards, as appropriate (e.g. state regulation, past accident history, generally accepted industry practices).

Chemicals:
1) The owners and operators should try to substitute less hazardous substances for extremely hazardous substances or minimize inventories when possible.

2) This is usually the most effective way to prevent accidents and should be the priority of a prevention program.

Equipment:

1) Facilities must implement a quality control program to ensure that components and materials meet design specifications and to construct the process equipment as designed.

2) Facilities must apply the same standard of care when modifying or repairing the facility.

3) Safety equipment and inherently safer technology can be used to lessen the hazards posed by an extremely hazardous substance (EHS). Making vessels containing flammable materials inert, using alternate processes that require lower temperatures or pressures, installing relief systems, determining process siting, installing anti-static devices and other equipment are common mechanisms to lessen the hazards.

4) Facilities should consult trade associations, industry consultants (e.g., Center for Chemical Process Safety, others) and safety engineers to determine standards and safety equipment employed at facilities.

Maintain a Safe Facility

An aspect of maintaining a safe facility is a review of information developed to ensure the safe operation of the facility. EPA inspectors will request and review standard operating procedures, evaluate the existence and implementation of employee training programs, review managing change procedures and evaluate the effectiveness of a facility’s incident investigation program. The following provides a description of these types of documents.

Standard Operating Procedures

Facilities are responsible for ensuring that the process and equipment are operated within safe limits. To achieve this, standard operating procedures (SOPs) should be written for every aspect of the processes. These procedures should identify safe upper and lower limits for process variables and identify corrective measures and emergency situations. These procedures should be correct and accurate, clear, concise, and written at the appropriate reading level for the operator. SOPs should include the various phases of operation, including pre-startup checks, startup, normal operations, temporary operations, normal shutdown and emergency shutdown. SOPs should also address receiving, storing, transferring and shipping of extremely hazardous substances to minimize the likelihood of a release from other than chemical process areas. These procedures should clearly warn about conditions/practices likely to cause a release as identified in the PHA and steps that the employee/operator must take to prevent a release if these conditions are encountered.

Training Programs

Facilities must implement and evaluate programs for training employees on the hazards of the substances, any additional hazards presented by the processes, proper process operations (including the significance of process variable changes and consequences), proper maintenance procedures, and procedures for receiving, storing, transferring and shipping hazardous substances. Training programs should contain clear and concise objectives and the owners and operators should ensure that evaluation of trainee competence is included in the program.

Managing Changes

When changes in the processes are planned, the owners and operators should evaluate how those changes will affect the hazards identified in the PHAs. These changes should be evaluated to determine if hazards, materials of construction, operating and maintenance procedures, and prevention programs need to be updated.

Incident Investigation Program

When an incident occurs that results in a release or that could have escalated into a release, facilities should investigate the cause of the incident/accident. The investigation should result in recommendations designed to prevent future similar occurrences. Facilities should document how these recommendations were evaluated and implemented or why recommendations were NOT implemented. Investigation findings should be evaluated to ensure that any new information is included in periodic PHA reviews, changes in procedures, and changes in operation and maintenance programs.

Self Audits

Facilities should practice self auditing of the facility’s prevention programs. Generally a self audit would involve a third party evaluating the effectiveness of a facility’s prevention and mitigation program.

Preventive Maintenance Programs

Maintenance requirements should have been identified in the design phase of a process. However, as facilities are operated, experience may provide a more realistic picture of maintenance requirements. Facilities should ensure that a PREVENTIVE MAINTENANCE program is implemented that maintains the mechanical integrity of the process equipment and the safety mechanisms. This program should, at a MINIMUM, meet guidelines from standard industry sources such as the American Petroleum Institute (API), American Society of Mechanical Engineers (ASME), National Association of Corrosion Engineers (NACE), American National Standards Institute (ANSI), and the American Institute of Chemical Engineers (AIChE). At a MINIMUM, the PREVENTIVE MAINTENANCE program should include:
a) schedules for replacement, repairs, or regular maintenance (cleaning, lubrication, other) to the equipment,
b) quality requirements for spare parts,
c) installation and repair procedures,
d) testing,
e) quality controls,
f) replacement in kind controls, and
g) maintenance enforcement procedures

Reasonably detailed maintenance records should be kept for periodic maintenance program evaluation.

3) Has the owner and operator minimized the consequences of a release?

In order to assess whether an owner and operator has minimized the consequences of an accidental release, the Regional inspector will, at a minimum, review the emergency response plan at the facility. The emergency response plan should include the following elements:
a) planning

b) coordination with local officials

c) training and exercises

Planning

A facility should develop an emergency response plan that SPECIFCIALLY addresses release scenarios developed from the PHAs and historical information. The potential releases identified in the PHAs should be used in preparing the emergency response plans. Planning and preparation includes:

a) identifying populations impacted by a release

b) systems and environments that may be impacted by a release

c) specific procedures for employees to follow to stop further chemical releases and/or mitigate the effects of the substances released

The plan should also identify emergency response equipment that is available for response activities and state whether the equipment is located at the facility or its location within the community.

Guidance such as the “one plan” guidance can be used to determine the necessary elements of an emergency plan for a specific industry. At a minimum, the plan should contain the following elements:

a) Anticipation of the types of releases that may occur from the process

b) Mitigation process

c) Notification process to local responders

d) Local responder involvement

Coordination with Local Officials
The facility should open communications with local emergency planning and response officials, including the local emergency planning committee (LEPC), if one exists. Involvement in the activities of the LEPC can have positive effect on the facility’s emergency response program. The facility should provide the LEPC with draft versions of any emergency response program related to local emergency planning efforts. The facility should coordinate with the LEPC, local response organizations, local hospitals, and other response organizations upon completion of the emergency response plan for the facility.

Training and Exercises
All employees need to be trained on recognizing circumstances which are “out of the norm” (i.e., how to immediately recognize that an accident is occurring), as well as what to do in the event of an accident. This training would be specific to the facility and include relevant SOP’s and emergency plans. Once plans have been developed, training needs identified and met, and equipment has been identified and obtained; facilities should conduct periodic exercises to ensure that the plan is adequate to address the identified emergency scenarios. Facilities should include local and state emergency response and management agencies in the planning process as well as in exercises designed to test and evaluate the emergency response plan. Because much of the specific knowledge and skills necessary to handle hazardous chemicals resides at the facility and may be lacking in the response community, the owners and operators may decide to provide training specific to the hazardous chemicals and mitigation techniques to state and local response personnel.  Depending on the hazards of the chemical and the potential impact of a chemical release, the owners and operators should evaluate the need for and the effectiveness of warning systems, evacuation procedures, and/or shelter-in-place procedures that protect employees. The owners and operators should plan mock emergencies to practice procedures on a regular basis to test workers’ ability to perform in the event of an emergency.

Evaluating Prevention and Release Mitigation Programs

Here is a SAMPLE of questions that EPA will be seeking answers to during a GDC inspection.  We can use these to gauge our readiness for an EPA GDC inspection.

Hazard Identification Checklist

1) Have the owners and operators completed Process Hazards Analyses (PHA) for each process involving extremely hazardous substances (EHSs)?

2) Did the owners and operators use appropriate hazard assessment techniques?

3) Are the PHAs complete, accurate, correct, and do they & identify the intrinsic hazards of the substances and the processes?

4) Do PHA(s) identify the potential releases from the processes?

5) Do PHA(s) identify the potential impacts on the public and the environment?

6) Are these impacts realistic, accurate, correct?

Facility Design/Maintenance Checklist
a. Design

1) Are design documents for each EHS process correct, accurate, and current?

2) Do designs minimize risks of releases based on PHA’s?

3) Evaluation of design documents:

4) Are design codes used in the design identified and appropriate to the processes?

5) Was the facility constructed or modified according to design specifications?

6) Are there quality control procedures to ensure construction materials meet design specifications?

7) Do critical process components have redundant systems installed?

8) Has the facility design been updated to current codes and standards?

9) Are there remote monitoring and remote control capabilities for dealing with upsets?

b. Maintenance

1) Are there preventive maintenance procedures to ensure the mechanical integrity of the process equipment?

2) Do the maintenance procedures and preventive schedules follow generally accepted engineering practices?

3) Are maintenance personnel trained on the intrinsic hazards of the chemicals, the processes, and in the maintenance procedures?

4) Does training include understanding and proficiency evaluation?

5) Is there a maintenance supplies and parts inventory that corresponds with maintenance schedules, especially for critical components that affect process safety?

6) Is there a quality control program to ensure spare parts meet specifications, and is it implemented and working?

7) How has the facility minimized the possibility of an unauthorized entry?

c. Operations

1) Are there Standard Operating Procedures (SOPs) for each process?

2) Are the SOPs current?

3) Do SOPs cover each phase of each process (startup, normal operations, shut down, emergency shut down)?

4) Are SOPs clear, concise, correct, and written at the appropriate level of understanding for the operator?

5) Do SOPs identify upper and lower limits for operating parameters like temperatures, pressures, flows, volumes, levels, pH, concentrations, etc.?

6) Do limits for parameters agree with those identified in the PHAs?

7) Are process equipment components such as valves, gauges, pumps, vessels clearly marked and do the labels match SOP nomenclature?

8) Are SOPs revised periodically?

9) Are SOPs revised after incidents or process changes?

d. Training

1) Are employees trained and tested for competence on the safe operating procedures for the processes they operate?

2) Is training adequate?

3) Are employees trained on the intrinsic hazards of the substances and the process, and the consequences of deviation from the limits for process parameters?

4) What is the frequency of the training?

5) Are there communication procedures to ensure that instructions given are clear and understood correctly (i.e., “repeat back” the instructions)?

6) Are employees trained to recognize emergency situations and are they authorized to take actions to prevent them or mitigate them?

7) Does training reflect current operations?

Consequence Minimization Checklist
1) Do the hazard assessments identify potential release scenarios and their potential impacts on the public and the environment?

2) Is there an emergency response plan to respond to emergency situations based on the accidental release scenarios?

3) Does the plan clearly identify responsibilities, functions, and contacts for emergency response?

4) Does the plan include coordination with local emergency responders?

5) Are employees trained on emergency response actions?

6) Are routine exercises conducted to practice emergency response?

7) Are employees trained to recognize emergency situations and are they empowered to take actions to prevent them or mitigate them?

8) Is the plan revised as processes change?

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