Laws and Regulations

1
Laws and Regulations

• Laws and regulations are major tools for
  protecting people and the environment.
• Congress is responsible for passing laws that
  govern the United States.

2
Creating a Law in US

• A law is created with a three-step process
• Step 1 A member of Congress proposes a bill. A
  bill is a document that, if approved, become a
  law.
• Step 2 If both houses of Congress approve the
  bill, it is sent to the president, who has the
  option to either approve it or veto it. If
  approved, it becomes a law that is called an act.
• Step 3 The complete text of the law is published
  in the United States Code (USC). The code is the
  official record of all federal laws.

3
Creating a Regulation or Standard

• To make the laws work on a day-to-day level,
  Congress authorizes governmental organizations,
  including the EPA and OSHA, to create regulations
  and/or standards. After the regulation is in
  effect, the EPA or OSHA has the responsibility
  (1) to help citizens comply with the law and (2)
  to enforce the regulation.

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Regulation/Standard Creating Procedure

• The process for creating a regulation and/or
  standard has two steps
• Step 1 The authorized organization or agency
  decides when a regulation is needed. The
  organization then researches, develops, and
  proposes a regulation. The proposal is listed in
  the Federal Register (FR) so that the public can
  evaluate it and send comments to the
  organization. These comments are used to revise
  the regulation.
• Step 2 After a regulation is rewritten, it is
  posted in the Federal Register as a final rule,
  and it is simultaneously codified by publishing
  it in the Code of Federal Regulations (CFR).

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History

• Before 1936 regulations concerning occupational
  health were poorly administered by state and
  local governmental agencies. During this era,
  staffs and funds were to small to carry out
  effective programs.
• In 1936 the federal government enacted the
  Walsh-Healy Act to establish federal safety and
  health standards for activities relating to
  federal contracts.
• The concepts promulgated by the Walsh-Healy Act,
  although not adequate by todays standards, were
  the forerunners of our current occupational
  health and safety regulations.
• Between 1936 and 1970 a number of states enacted
  their own safety and health regulations.
• The OSHAct of 1970 was developed to solve these
  problems and to give a nationally consistent
  program with the funding necessary to manage it
  effectively.

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OSHA and NIOSH

• As a result of the OSHAct, sufficient funding was
  committed to create and support the Occupational
  Safety and Health Administration (OSHA), which
  manages and administers the governments
  responsibilities specified in the OSHAct, and the
  National Institute for Occupational Safety and
  Health (NIOSH), which conducts research and
  technical assistance programs for improving the
  protection and maintenance of workers health.
• Examples of NIOSH responsibilities include (1)
  measuring health effects of exposure in the work
  environment, (2) developing criteria for handling
  toxic materials, (3) establishing safe levels of
  exposure, and (4) training professionals for
  administering the programs of the act.
• NIOSH develops data and information regarding
  hazards, and OSHA uses these data to promulgate
  standards.

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• Some laws and regulations particularly relevant
  to the chemical industry are shown in Table 3-1.
• As illustrated in this table, the distinction
  between laws (USC) and regulations (CFR) is
  global versus detail.

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Table 3-1 A Few Laws (USC) and Regulations (CFR)
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• Highlight of OSHA enforcement rights are
  illustrated in Table 3-2.
• Table 3-3 provides a summary of relevant safety
  legislation, and Figure 3-1 shows how the amount
  of legislation has increased.

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Table 3-2 Highlights of OSHAS Right of
Enforcement
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Table 3-3 Federal Legislation Relevant to
Chemical Process Safety (1)
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Table 3-3 Federal Legislation Relevant to
Chemical Process Safety (2)
13
Table 3-3 Federal Legislation Relevant to
Chemical Process Safety (3)
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Table 3-3 Federal Legislation Relevant to
Chemical Process Safety (4)
15
Figure 3-1 Number of federal laws relevant to
chemical process safety.
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OSHA Process Safety Management

• On February 24, 1992, OSHA published the final
  rule Process Safety Management of Highly
  Hazardous Chemicals. (PSM) Process safety
  management (PSM) was developed after the Bhopal
  accident (1985), to prevent similar accidents.
  The standard is performance oriented, that is, it
  sets general requirements for management of
  hazardous chemicals.

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• The PSM standard has 14 major sections (1)
  employee participation, (2) process safety
  information, (3) process hazard analysis, (4)
  operating procedures, (5) training, (6)
  contractors, (7) pre-startup safety review, (8)
  mechanical integrity, (9) hot work permits, (10)
  management of change, (11) incident
  investigations, (12) emergency planning and
  response, (13) audits, and (14) trade secrets.
• (1) Employee participation requires active
  employee participation in all the major elements
  of PSM. Employers must develop and document a
  plan of action to specify this participation.

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• (2) Process safety information is compiled and
  made available to all employees to facilitate the
  understanding and identification of hazards. This
  information includes block flow diagrams (BFD) or
  process flow diagrams (PFD), process chemistry,
  and process limitations, such as temperatures,
  pressures, flows, and compositions. Consequences
  of process deviations are also required. This
  process safety information is needed before
  training, process hazards analysis, management of
  change (MOC), and accident investigations.

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• (3) Process hazard analysis (PHA) must be
  performed by a team of experts, including
  engineers, chemists, operators, industrial
  hygienists, and other appropriate and experienced
  specialists. The PHA needs to include a method
  that fits the complexity of the process, a
  hazards and operability (HAZOP) study for a
  complex process, and for less complex processes a
  less rigorous process, such as what-if scenarios,
  checklists, failure modes and effects analysis,
  or fault trees. Every PSM process needs an
  updated PHA at least every five years after the
  initial analysis is completed.

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• (4) Operating procedures that facilitate the safe
  operation of the plant must be documented.
• They need to cover, at a minimum, initial
  startup, normal operations, temporary operations,
  emergency shutdown, emergency operations, normal
  shutdown, startup after normal and emergency
  shutdowns, operating limits and consequences of
  deviations, safety and health considerations,
  hazardous properties of the chemicals, exposure
  precautions, engineering and administrative
  controls, quality control specifications for all
  chemicals, special or unique hazards, and safety
  control systems and functions.
• Safe work practices also need to be documented,
  such as hot work, lockout/tagout, and confined
  space.
• These operating procedures are updated
  frequently, with the frequency being set by the
  operating personnel.

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• (5) An effective training program helps employees
  understand the hazards associated with the tasks
  they perform. Maintenance an operation personnel
  receive initial training and refresher training.
  Operators need to understand the hazards
  associated with every task, including emergency
  shutdown, startup, and normal operation.
  Refresher training is given every three years and
  more often if necessary the operators decide on
  the frequency of the refresher training.

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(6) Contractors are trained to perform their
tasks safely to the same extent as employees.
Even when selecting contractors, the employees
need to consider the contractors safety
performance in addition to their skills. (7) A
pre-startup safety review is a special safety
review that is conducted after a modification to
the process or operating conditions has been made
and before the startup. In this review a team of
reviewers ensures that (1) the system is
constructed in accordance with the design
specifications, (2) the safety, maintenance,
operating, and emergency procedures are in place,
(3) the appropriate training is completed, and
(4) the recommendations from the PHA are
implemented or resolved.
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• (8) The mechanical integrity section of the PSM
  standard ensures that the equipment, piping,
  relief system, controls, and alarms are
  mechanically sound and operational. The
  requirements include (1) written procedures to
  maintain functioning systems, (2) training
  regarding preventive maintenance, (3) periodic
  inspections and testing based on vendor
  recommendations, (4) a process to correct
  deficiencies, and (5) a process to ensure that
  all equipment and spare parts are suitable.

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(9) The PSM standard ascertains that a system is
in place to prepare and issue hot work permits
before conducting hot work activities (welding,
grinding, or using spark-producing equipment).
The permit requires dates authorized for hot
work, the equipment involved in the work, a
system to maintain and document certification,
identification of openings where sparks may drop,
the types and numbers of fire extinguishers,
identification of fire watches, an inspection
before the work, authorization signatures,
identification of flammable materials in the
area, verification that the surrounding area is
not explosive, verification that combustible
materials are removed or covered appropriately,
identification and closure of open vessels or
ducts, and verification that welded walls are not
flammable.
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• (10) Under the management of change section of
  the PSM standard employees are required to
  develop and implement documented procedures to
  manage changes in the process chemistry, process
  equipment, and operating procedures. Before a
  change occurs (except for replacement-in-kind),
  it must be reviewed to ascertain that it will not
  affect the safety of the operation. After the
  change has been made, all the affected employees
  are trained, and a pre-startup review is
  conducted.

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• (11) The PSM standard mandates incident
  investigation.
• Employers must investigate all incidents that
  have or could have resulted in a major release or
  accident within 48 hours of the event.
• The regulation requires an investigation team
  composed of people, including operators, who are
  knowledgeable about the system.
• After the investigation, the employers are
  required to appropriately use the investigation
  recommendations.

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(12) The intent of the PSM element for emergency
planning and response is to require employers to
respond effectively to the release of highly
hazardous chemicals. Although the regulation
requires this activity for companies with more
than 10 employees, this element should be part of
a program for even the smallest organizations
that handle hazardous chemicals.
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(13) Under the audits section of the PSM standard
employers are required to certify that they have
evaluated their compliance with the standard at
least every three years. The recommendations from
the audit must be followed. The audit reports
need to be retained as long as the process
exists. (14) The trade secrets section of the PSM
standard ensures that all contractors are given
all the information relevant to operating in the
plant safely. Some personnel may need to sign
secrecy agreements before they receive this
information.
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EPA Risk Management Plan

• On June 20, 1996, the EPA published the Risk
  Management Plan (RMP) as a final rule. This
  regulation is also a response to the Bhopal
  accident.

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• It is recognized by industry and the government
  as an excellent regulation that will reduce the
  number and magnitude of accidents if it is
  understood and practiced as intended.
• The RMP regulation is aimed at decreasing the
  number and magnitude of accidental releases of
  toxic and flammable substances.
• Although the RMP is similar to the PSM regulation
  in many respects, the RMP is designed to protect
  off-site people and the environment, whereas PSM
  is designed to protect on-site people.

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• The RMP is required for plant sites that use more
  than a specified threshold quantity of regulated
  highly hazardous chemicals.
• The RMP is a site responsibility (the site may
  have several processes), whereas PSM covers every
  covered process on the site.

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Elements of RMP

• hazard assessment,
• prevention program,
• emergency response program,
• documentation that is maintained on the site and
  submitted to federal, state, and local
  authorities. This information is also shared with
  the local community. The RMP document is updated
  when the process or chemistry changes or when a
  governmental audit requests an update.

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Hazard Assessment

• Hazard assessment is a consequence analysis for a
  range of potential hazardous chemical releases,
  including the history of such releases at the
  facility.
• The releases must include the worst-case scenario
  and the more likely but significant accident
  release scenarios. A risk matrix can be used to
  characterize the worst-case and more likely
  scenarios.

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EPA-Required Consequence Analyses

• A single worst-case release scenario is analyzed
  for all covered flammable materials on the site,
  and only one flammable substance is analyzed for
  other more likely scenarios
• A single worst-case release scenario is analyzed
  for all toxic substances on the site, and more
  likely releases are analyzed for each toxic
  substance covered by the rule.

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• The worst-case scenario is based on releasing the
  entire contants of a vessel or piping system in a
  10-minute period under worst-case meteorological
  conditions (F stability and 1.5 m/s wind speed).
• Passive mitigation measures (for example, dikes)
  can be used in the calculation process therefore
  the release rate for liquid spills corresponds to
  the evaporation rate.
• Alternative release cases for toxic substances
  cover scenarios with toxic concentrations beyond
  the fence line.
• Alternative cases for flammable substances cover
  scenarios that may cause substantial damage off
  site and on site.
• The release scenarios that have a potential to
  reach the public are of the greatest concern.
• Those with no off-site potential damage are not
  required to be reported.

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• Dispersion model calculations are normally used
  to estimate downwind concentrations these
  concentrations are the basis for determining the
  consequences resulting from toxicity, fires,
  and/or explosions.
• For those not interested in using dispersion
  models, the standard includes lookup table for
  all the listed substances to help a facility
  determine the impact distances for specific
  release scenarios.
• The RMP requires only an analysis of the
  consequence and not the probability. Therefore
  the results are not a true determination of risk,
  because risk is composed of both consequence and
  probability.

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Prevention Program

• The second requirement of the RMP is a prevention
  program. The prevention program has 11 elements,
  compared to the 14 elements of the PSM standard.
• As shown is Table 3-4, many of these elements are
  duplicated. Fortunately, the EPA made a
  deliberate attempt to retain the same
  requirements wherever possible, although
  differences exist because the EPA and OSHA have
  different responsibilities.

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Table 3-4 Comparison of the PSM and RMP
Prevention Programs (1)
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Table 3-4 Comparison of the PSM and RMP
Prevention Programs (2)
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Emergency Response Program

• This program delineates the steps to be taken by
  the facilitys employees in response to
  accidental releases of hazardous materials.
• It also establishes procedures for notifying the
  local community and the appropriate emergency
  response agencies. Training is for all employees
  on the topics relevant to emergency response.
• The requirements include drills to test the plan
  and to evaluate its effectiveness, and the plan
  must be revised based on the findings of these
  drills.

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• The plan must be coordinated with local emergency
  response plans developed by Local Emergency
  Planning Committees (LEPCs) and local emergency
  response agencies.
• As with similar OSHA regulations, the Resource
  Conservation and Recovery Act (RCRA), and the
  Spill Prevention Control under the Clean Water
  Act, the emergency response plan must be
  maintained at the facility and must include
  descriptions of all mitigating system.