1. Process Safety Management / Risk Management Program (PSM/RMP) Five-Year Revalidation HanhPhuc Nguyen
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2. Overview Regulatory Review Five-Year Revalidation Process
OSHA Process Safety Management (PSM)
EPA Risk Management Program (RMP)
General Duty Clause
Five-Year Revalidation Process
Process Hazard Analysis
Hazard Assessment
Risk Management e Submit (RMPeSubmit)

3. Regulatory Review
There are two agencies that have chemical related safety and accident prevention regulations:
Occupational Safety and Health Administration (OSHA)
regulates PSM
Environmental Protection Agency (EPA)
enforces the RMP
WRT Risk & Safety
OSHA
EPA has authority to bring administrative and judicial actions against violators. Judicial actions can be civil and criminal in nature. Penalties can be up to $25,000 per day for each violation.
Worker Safety
vs.
Neighbor Safety

4. Regulatory Review OSHA PSM: EPA RMP:
OSHA published the proposed standard - “Process Safety Management of Highly Hazardous Chemicals” in the Federal Register on July 17, 1990.
The Federal PSM standard became effective on May 24, 1992.
EPA RMP:
40 CFR Part 68, Chemical Accident Prevention Provisions, was published on June 21, 1996, requires facilities to develop a Risk Management Program to manage the potential risks associated with processes that use regulated substances.
Existing facilities were required to comply by June 21, 1999.

5. Regulatory Review Applicability:
Any facility that handles, stores, uses, or produces in excess of the threshold quantity of a listed regulated substance in any single process. A process is any group of interconnected vessels and separate vessels located such that a highly hazardous chemical could be involved in a potential release.
Regulated Substance
OSHA PSM
EPA RMP
Anhydrous Ammonia
10,000 lbs
Aqueous Ammonia
15,000 lbs (≥44%)
20,000lbs (≥20%)
Chlorine
1,500 lbs
2,500 lbs
Sulfur Dioxide
1,000 lbs (liquid)
5,000 lbs (anhydrous)

6. Regulatory Overlap OSHA PSM EPA’S RMP PSI PHA SOPs Training
Mechanical Integrity
Contractors
Employee Participation
Compliance Audit
PSSR
MOC
Incident Investigation
Hot Work
Emergency Plan
Management Programs
RMP*eSubmit
Hazard Assessment
EPA’S RMP

7. General Duty Clause
Clean Air Act Amendments of 1990, Section 112(r) - General Duty Clause:
Purpose and General Duty - It shall be the objective of the regulations and programs authorized under this subsection to prevent the accidental release and to minimize the consequences of any such release of any substances listed or any other extremely hazardous substance.
Obligations Under General Duty Clause:
identify hazards which may result from such releases using appropriate hazard assessment techniques;
design and maintain a safe facility taking such steps as are necessary to prevent releases; and
minimize the consequences of accidental releases which do occur.

8. General Duty Clause
Occupational Safety & Health Act - General Duty Clause Section 5 (a)(1):
“Each Employer shall furnish to each of his employees, employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.”
Suggested Minimum Strategy
Conduct Hazard Review & Determine Off-Site Consequences
Reference: EPA Guidance for Implementation of the General Duty Clause (550-F , March 2009)

9. Process Hazard Analysis Revalidation Purpose & Requirements
What’s the purpose?
Comply with the OSHA PSM [29 CFR (e)(6)] and EPA RMP [40 CFR 68.67(f)] regulations.
Ensure that the PHA is consistent with the current process.
What are the requirements?
Revalidate and update at least every five years after its initial or previous completion.
Revalidation to be performed by a qualified team.

10. Process Hazard Analysis Revalidation Philosophy – To Re-do or Read Through?
How should I decide?
Thoroughness of the initial or previous PHA
Did we re-do or read through five years ago?
Who was present in the previous PHA?
Changes to the process in the last five years – significant or minor?

11. Process Hazard Analysis Revalidation PHA Requirements
OSHA Letter of Interpretation (June 28, 1998):
“Employers must establish the scope and extent of their PHA updates and revalidations to include at least the following: evaluations of existing PHAs for accuracy and completeness using the criteria set forth in (e)(3);
checks to ensure that modifications to processes since the last PHAs have gone through management of change procedures or PHAs when required and that those changes are reflected in the PHAs;
an evaluation of process safety information (PSI) to ensure that it is complete, current and accurate;
verifications to ensure PHA specified procedures are adequate, up-to-date and are being implemented;
determinations that existing PHA recommendations have been documented in their required respective areas such as PSI, PHAs, and procedures (operating, mechanical integrity, emergency response, etc.) and have been implemented;
a review of all incident investigation reports required by (m) to assure all affected PSI, procedures, training, etc., have been updated to reflect recommendations set forth in the subject reports and that appropriate information from those reports have been incorporated into the PHAs.
Finally, OSHA intends that the PHA update and revalidation be documented.”

12. Process Hazard Analysis Revalidation Preparing for the PHA - Summary
List any changes to the process in the last five years (i.e., MOC review).
Verify accuracy of PSI:
Piping diagrams
Normal operating conditions
Safety systems
Ensure SOPs are current.
Review implementation status of previous PHA recommendations.
Review five year accident history / incident investigation records.

13. Process Hazard Analysis Revalidation Preparing for the PHA – RAGAGEP
Define recognized and generally accepted good engineering practices (RAGAGEPs) used to design, operate, and maintain your process.
Mechanical, Fire, and Building Codes
Standards – ANSI/ASHRAE 15, ANSI/IIAR 2
Guidelines – IIAR Bulletins, Chlorine Institute Pamphlet, API
Manufacturer’s Recommendations

14. Process Hazard Analysis Revalidation Preparing for the PHA –
Selecting the PHA Methodology
The PHA methodology must be:
“appropriate to determine and evaluate the hazards of the process being analyzed.” [40 CFR 68.67(b) & 29 CFR (e)(2)]
What methodology did you use?
What-If (IIAR Questions)
Checklist
What-If / Checklist
HAZOP (Hazard & Operability Study)
Failure Mode & Effects Analysis (FMEA)
Fault-Tree Analysis
“appropriate to the complexity of the process”

15. Process Hazard Analysis Revalidation PHA – Basic Methodology
Identify hazards associated with the process
Determine causes and consequences of each potential hazard
Discuss any incidents (facility and/or industry)
Identify administrative and engineering safeguards
Determine risk ranking
Postulate mitigation measures to reduce consequences and/or likelihood
Consequences
Frequency A:
Frequent B:
Periodical C:
Occasional D:
Possible E:
Improbable
I: Catastrophic 1 2 4
II: Severe 3
III: Moderate
IV: Slight

16. Process Hazard Analysis Revalidation Preparing for the PHA – Who’s on your team?
“The PHA shall be performed by a team with expertise in engineering and process operations, with at least one employee who has experience and knowledge specific to the process being analyzed. Also, one member of the team must be knowledgeable in the specific PHA methodology being used.” [40 CFR 68.67(d) & 29 CFR (e)(4)]
Design Engineers
Operations and Maintenance Personnel
Engineering/Design Contractor
Safety / Environmental Management
PHA Leader & Recorder

17. Process Hazard Analysis Revalidation Performing the PHA
Ensure previous PHA adequately satisfied PHA requirements:
Previous incidents
Safeguards and the consequences of the safeguard failing.
Engineering and administrative control relationships.
Facility Siting
Human Factors
Qualitative Assessment of Frequency and Consequences

18. Process Hazard Analysis Revalidation Recommendation Tracking
Develop a written schedule for completing action items.
Assign responsibilities.
Review status of recommendations and ensure progress is being made periodically.
Document recommendation review meetings and actions taken to implement recommendations.
Maintain evidence that shows progress or completion of action items.
Review status/outcomes with operating, maintenance, and any other persons who are affected by the recommendations.

19. Process Hazard Analysis Revalidations Documentation
All Process Hazard Analysis Study reports must be maintained for the life of the process.
Including recommendation resolution.
Sign In Sheets.
Piping Diagrams from the date of the study.
Team Leader Qualifications.
Methodology.
Regulatory Invites as applicable.

20. Hazard Assessment Hazard Assessment regulatory notations:
EPA: 40CFR § – 68.42
Hazard Assessment Update Requirements:
“The owner or operator shall review and update the off-site consequence analysis at least once every five years.”
Also, if changes to the process which “might reasonably be expected to increase or decrease the distance to the endpoint by a factor of two or more”, the Hazard Assessment shall be revised with the results being submitted in a revised RMP.

21. Hazard Assessment Elements
Off-Site Consequence Analysis (OCA)
Identify the worst-case release for each regulated substance;
Identify the alternative release scenario for each regulated substance;
Define the areas of potential off-site impacts for worst-case release and alternative release scenarios;
Identify affected population, public receptors, and environmental receptors within worst-case and alternative release scenario impact regions.
Five-Year Accident History

22. Hazard Assessment Worst Case Release Scenario
Determine released amount used in the modeling (Maximum capacity of Largest Vessel / Maximum intended inventory of regulated substance)
Review passive mitigation measures (vessel located in an enclosure or outside?)
Review assumptions and modeling technique (the use of EPA Guidance documents is suggested)

23. Hazard Assessment Alternative Release Scenario
Review Accident History – Have there been any releases or near releases at your facility that fit the definition of Alternate Release?
Must be more likely to occur than the worst case
Must reach an endpoint offsite (unless no such scenario exists)
Review passive and active mitigation measures considered (room ventilation, water diffusion tank, automatic shut offs [safety cutouts, high level shut downs], etc.)
Review assumptions and modeling technique (the use of EPA Guidance documents is suggested)

24. Hazard Assessment Off-site Impacts
Residential Population
Most Recent Census Data
References:
Marlplot
Public Libraries
Local government offices or planning commissions
Public
schools, hospitals, daycare centers, prisons, parks/recreational areas, and major commercial office, and industrial buildings.
On-site facilities to which the public has routine and unrestricted access.
Environmental
National or state parks, forests, or monuments;
Officially designated wildlife sanctuaries, preserves, refuges, or areas;
Federal wilderness areas.
Data Sources
US Geological Survey Maps (USGS)
Data sources containing USGS data.

25. Qualifications for Five-Year Accident History
The EPA’s Risk Management Program (40 CFR § 68.42(a))[2] Five-Year Accident History reporting requirement:
“The owner or operator shall include in the five-year accident history all accidental released from covered processes that resulted in deaths, injuries, or significant property damage on site, or known offsite deaths, injuries, evacuations, sheltering in place, property damage, or environmental damage.”

26. Hazard Assessment Five-Year Accident History
Data Required:
Date, time, and approximate duration of the release;
Chemicals released;
Estimated quantity released in pounds;
Type of release event and its source (gas release, liquid spill, fire, explosion);
Release source (storage vessel, piping, process vessel, transfer hose, valve, pump);
Weather Conditions (if known) (temperature, wind speed/direction, stability class, precipitation);
On-site impacts (number of deaths, injuries, property damage);

27. Hazard Assessment Update Tips
No change in chemical inventory / capacity of largest vessel and no incident history meets the Alternative Release definition and existing scenario is valid
 VERIFY dispersion calculations previously completed
Update Maps & Population
Update Sensitive Receptors lists
2010 US Census was released!!!

28. Risk Management Plan Risk Management Plan regulatory notations:
EPA: 40CFR § –
RMP*eSubmit data elements submitted to EPA

29. EPA Risk Management Plans
Historically were submitted via 3.5” floppy diskette; now via internet (RMP*eSubmit on EPA’s CDX website).
Following your submittal, Keep the letter issued by EPA! It includes your next 5 year re-submission due date along with your unique facility ID #

30. Risk Management Plan Update Requirements
“At least once every five years from the date of its initial submission or most recent update.”
Within 6 months of a change that requires a revised PHA or Hazard Review.
Within 6 months of a change that requires a revised off-site consequence analysis.
Within 30 days of a change in the owner or operator of the facility.

31. Risk Management Plan Corrections
Within 6 months of an applicable accidental release
Within 30 days of a change to the Emergency Contact Information (see section 1.8 of the RMP*Submit)
Changes to the chemical process: revise the PSM/RMP program documentation no later than 60 days after the modifications.

32. Risk Management Plan Submitting to EPA
No hard copy submittal as of January 2010.
EPA’s RMP*eSubmit Software
Online submittal on EPA’s Central Data Exchange system ( )
Standard user ID and password protocols
Electronic Signature Agreement
Ability to access / update your submission on line at any time
Due every 5 years
Reference:
EPA Risk Management Plan RMP*Submit Users’ Manual, EPA 555-B , September 2009.

33. Questions and Answers