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Hazards and Safety Management (MQA201T)
Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
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Prepared by: Dhruvi Parmar
192650824007
M. Pharmacy (Semester II)
Hazards and Safety Management (MQA201T)
Hazards and Safety Management (MQA201T)
Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
Page
2
INDEX
Sr.no. CONTENTS
1 Introduction
2 Sources of chemical hazards
3
Hazards of Organic synthesis, sulphonating
hazard, Organic solvent hazard
4 Control measures for chemical hazards
5
Management of combustiblegases, Toxic gases
and Oxygen displacing gases management
6 Regulations for chemical hazard
7 Management of over-Exposure to chemicals
8 TLV concept
9 Study Questions
Hazards and Safety Management (MQA201T)
Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
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 INTRODUCTION:
A chemical hazard is a type of occupational Hazard caused by exposure to chemicals in
the workplace. Exposure to chemicals in the workplace can cause acute or long-term
detrimental health effects.
HAZARD: Any situation that has potential/ Capability to cause injury/ harm to the worker,
damage to the property, Loss/contamination to environment.
Hazard is a situation that poses a threat to life, health, property, or the environment. Industrial
hazard can be defined as any condition produced by industries that can cause injury or death
to personnel or loss of product or property.
A chemical hazard is any substance that can cause harm, primarily to people. Chemicals of
all kinds are stored in our homes and results in serious injuries if not properly handled.
An element or mixture of elements or synthetic substance that are considered harmful to
environment is termed as Chemical Hazards.
 SOURCE OF CHEMICAL HAZARDS:
1. Ingestion: By swallowing the chemical
 Chemicals may be swallowed accidentally if food or cigarettes (or hands) are
contaminated. For this reason student and workers should not drink, eeat or smoke in
areas where they may be exposed to toxic chemicals.
2. Inhalation: Breathing in the chemical
 Chemicals in the air are breathed in through the mouth or nose.
 Gases & vapours are absorbed through the lungs directly into the bloodstream
 The size of dust particles or mist droplets can affect where the chemical settles in the
respiratory tract.
3. Absorption: Penetration of chemical in skin
 The chemical soaks through the skin and passes through the skin into the body
which enters the bloodstream.
4. Injection:
 It can occur when a sharp object (needle) punctures the skin and injects a chemical
(or virus) directly into the bloodstream.
5. Air born toxics:
 Irritants
 Ipecac, podophyllum, etc.
 Asphyxiants
 Carbon dioxide, monoxide, methane, ethane, and hydrogen cyanide
 Hydrogen sulphide, helium, nitrogen, etc.
 Narcotics/anaesthetics
 Acetone, ether, chloroform, methyl ethyl ketone, etc
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Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
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6. Carcinogens:
 Coal tar, creosote oil, anthracene oil, paraffin oils, and chromium,
 Nickel, cobalt, etc.
 Hazards may arise when impure or contaminated chemicals are used.
7. Sources of hazards in pharma industry:
 Handling and storage of huge quantity hazardous chemicals.
 Transferring, loading and unloading of solvents and chemicals to reaction vessels.
 Human errors while handling hazardous chemicals.
 Emission of hazardous air pollutants from reaction vessels due to overloading or
under designed reaction vessels.
 Volatile organic compounds (VOCs) releases from uncontained (or not connected to
scrubbers).
 Reaction vessels and most common VOCs include methanol, dichloromethane,
toluene, ethylene glycol, N, n dimethylformamide, and acetonitrile.
 Leaks of effluents from wastewater treatment plants or from effluent collection
sumps from process area.
TYPES OF HAZARDS
Chemical hazards are toxic, corrosive, irritant, carcinogenic, flammable, and mutagenic.
According to workplace hazardous materials information, chemical hazards are classified
as:
1. Class A: • Compressed gas.
• Dissolved gas or liquefied gas.
2. Class B: • Flammable gases.
• Flammable and combustible liquids.
• Flammable solid.
• Flammable aerosols.
• Reactive flammable material.
3. Class C: • Oxidizing materials: oxidizer and organic peroxide.
• Oxidizer: Chlorates, nitric oxide, peroxides, permanganates, perchlorates,
nitrites, nitrates, and easily oxidize metal powder.
• Organic peroxide: Tetra hydro furan, diethyl ether, dioxane, and methyl
isobutyl ether.
4. Class D: • Poisonous and infectious materials. e.g.: Cyanides, tea salts, and asbestos.
5. Class E: • Corrosive materials. e.g.: Inorganic acids and bases, hydrogen fluoride.
6. Class F: • Dangerous reactive materials. e.g.: Ethylene dioxide, organic azides, Na, Li.
• Pyrophosphoric materials. e.g.: White phosphorous, diethyl aluminium
chloride, and lithium.
Hazards and Safety Management (MQA201T)
Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
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HAZARDS OF ORGANIC SYNTHESIS,
SULPHONATING HAZARD, ORGANIC
SOLVENT HAZARD:
1. The hazards of organic synthesis:
 Organic chemical synthesis presents industrial hazards of three main types. First, the
active agents used to attack and modify the structure of organic compounds are, by
their very nature, exceptionally able to attack and modify the organic compounds of
the human body, thus producing highly poisonous effects. Second, the intermediate
compounds in most organic syntheses are often characterized by the readiness with
which they enter into chemical combination with other organic matter; they are
active. This often confers toxic properties of great variety on them. Third, the final
products, though they are medicines designed to be introduced into the human body,
may nevertheless produce severe poisoning under conditions of industrial exposure.
2. Sulfonating Agents
 The Sulfonating agents, chlorosulfonic acid (HOSO2CI) are extensively used in the
manufacture of p-acetyl amino benzene sulfonyl chloride. The fumes of the acid
itself are highly irritating, and in many sulfonation reactions, HCI gas and SO2 are
given off. It is often not economically feasible to trap these irritant by-products in a
small synthesis, and they are often vented into the outside air. This is a bad practice,
which will cause a large amount of bronchitis and conjunctivitis under adverse wind
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Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
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and weather conditions. Scrubbing towers of simple and cheap design, or very high
stacks, are usually required to eliminate the nuisance.
3. Final Products of Synthesis
i. Mepacrine and acriflavine
 Among the final products of organic synthesis, mepacrine itself deserves
mention as an especially troublesome primary irritant and sensitizer. Rather
extensive compressing and grinding, thrice repeated, are necessary to prepare
the material in the form of tablets; dust control during these operations is
mandatory, but extremely difficult, because of the structure of the machines
involved. In a study made at the Abbott Laboratories (Watrous, 1944), exposure
to the dust at levels between 035 and 4–2 µg/l was sufficient to cause
conjunctivitis in more than half of the workmen, and dermatitis, rhinitis, and
stomatitis in about a third. Similar symptoms have recently been described by
Barlow et al. (1946). Acriflavine another dye of the acridine series, possesses
similar, though weaker, irritant properties; workers bottling tablets of this dye
often suffer from a conjunctivitis of considerable severity if they transfer the
material to their eyes by injudicious rubbing with dust-stained hands.
ii. Nicotinic acid
 Nicotinic acid and its salts have a peculiar effect on the skin of certain workers
who handle these chemicals in bulk: This consists of a diffuse erythema on the
exposed parts of the skin, usually not accompanied by itching, and resembling
sunburn in appearance. It is usually transient, disappearing in from 12 to 24 h,
though sometimes it assumes a popular character on the 2nd day and lasts
several days.
iii. Powdered penicillin
 Dry powdered penicillin has proved to be a potent sensitizer and skin irritant in
all the American factories where it is handled. It may produce follicular
erythema, diffuse; popular rashes on the exposed parts of the body, or, in some
cases, severe generalized urticaria which persists for days or weeks after
exposure ceases. In the latter cases, it seems probable that a generalized
sensitivity has been created by the previous contact with the substance, and that
the urticaria results from systemic absorption of the powdered drug by
inhalation. In a series of four cases showing industrial dermatitis from exposure
to penicillin, Friedlaender et al. (1946) found the patients to be sensitive to pure
crystalline penicillin rather than to any particular impurity in the commercial
product.
iv. Local anesthetics
 The local anesthetics, procaine, butyl (butacaine sulfate), and butesin (n-butyl
amino benzoate), form a group of substances more or less prone to cause
sensitization and dermatitis on prolonged contact with the skin. The tendency
for procaine to sensitize the skin of dentists and others who frequently spilled
solutions on their hands were recognized many years ago and was one of the
factors which made prepared solutions in cartridges so popular with dentists.
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Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
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Women engaged in filling cartridges with sterile solutions of procaine are
subject to a characteristic occupational dermatitis caused by excess solution
overflowing from the tubes and running down their arms.
v. Neoarsphehamine
 Neoarsphenamine, sensitization of the skin in those who pack it in ampoules. In
such cases, the minute amount of dust which settles on the skin during the
process may cause popular rashes on the exposed skin areas. In one such case,
the skin was so sensitive to contact with the drug that a patch test made with a
few milligrams of the powder exhibited vesiculation within 12 h. Such marked
reactions, however, are rare; patch tests are usually negative, but many mild
dermatoses of this kind subside when contact with the drug ceases and recur
when it is resumed. Neoarsphenamine may also act as a primary irritant if it is
allowed to accumulate under the nails of those handling it.
vi. 2-methyl-1, 4-naphthoquinone
 2-methyl-1, 4-naphthoquinone, a synthetic form of Vitamin K, has the property
of sensitizing the skin and producing dermatitis. Workers who handle this
chemical present a dark-brown staining of the skin, and may later show popular
or eczematoid dermatitis.
vii. Sulfonechloramides
 At least two Sulfonechloramides which are used as antiseptics or disinfectants
have rather unusual properties as local irritants and sensitizers. When these
chemicals contaminate the working environment in the form of dust, they may
produce dermatitis, rhinitis, conjunctivitis, and bronchitis in their capacity as
primary irritants.
viii. Solvents
 Methyl alcohol is not commonly used. Ethyl alcohol offers medical hazards
only to the extent to which it is denatured with more toxic materials.
ix. Benzene
 Benzene itself is, unfortunately, such an excellent solvent for many active
principles, as well as for numerous important synthetic chemicals, that it
constitutes a major problem in the pharmaceutical industry. This is not the place
to describe or discuss the well-known facts about acute and chronic benzene
poisoning, except to affirm from my own experience that these well-established
facts are still completely unknown or disregarded in more backward works, and
that they cry out for more popular diffusion among workmen and foremen, even
in the most progressive organizations.
x. Chloroform and ethylene dichloride
 Chloroform and ethylene dichloride (1,2-dichloroethane) are occasionally used
to extract alkaloids and other fat soluble principles. Both solvents are liver
poisons, and men working with them under ordinary conditions may develop
certain vague symptoms which are referable to the gastrointestinal tract and
which suggest very slight liver damage. These consist of anorexia, a heavy
feeling in the epigastrium, and fatigue. At this time the urine may give a positive
test for urobilinogen, and in my experience, this is an indication for transferring
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the workman temporarily to other employment. By-products may accumulate
relatively high concentrations in parts of the plant and cause unexpected effects.
In pharmaceutical industry, most of the dermatitis can be attributed to synthetic
drugs, especially acridine and phenothiazines.
 CONTROL MEASURE FOR CHEMICAL
HAZARDS:
 The next three sections (a planner’s Guide, A Supervisor’s Guide, and A Worker’s
Guide) Provide detailed information on the roles and responsibilities in developing
and implementing effective chemical management, based on the phase in which each
person fits (i.e., planning, implementation, or execution). Each section serves as a
standalone guide for each phase.
 Use the following descriptions to select the section that best applies to your role in
the process:
i. A planner’s guide (blue) is for those persons (planners) responsible for planning
and initially designing the chemical management process. Planning roles include
but are not limited to prime contractor, owner, owner’s representative, licensee,
operator, and supplier.
ii. A supervisor’s guide (red) is for those persons (implementers/supervisors)
responsible for organizing workers and ensuring that the chemical management
process gets done. Implementation roles include but are not limited to supplier,
supervisor, and site supervisor.
iii. A worker’s guide (green) is for those persons (executers/workers) who physically
manage the chemicals on the job site and therefore are directly or indirectly
exposed to the chemicals. Execution roles include but are not limited to
supervisor, worker, and driver.
 Control of Chemical Hazards: Priorities for control action
i. Elimination: The most effective and reliable controls are those that result in the
elimination of the hazardous chemical.
ii. Substitution: Substitution of a hazardous chemical for a less hazardous one is the
next control of choice; however, care must be taken to ensure that the substituted
chemical does not introduce new hazards. Substitution also may involve using the
chemical in a less hazardous form or process (e.g., use of the chemical in a pellet
form rather than a dust).
iii. Isolation: Isolation of the chemical in time or space from those potentially
exposed can be an effective means of control (e.g., locating people in a protected
control room, installing a buffer area around a chemical reactor, using the
material when people are not in the vicinity).
iv. Engineering controls: Engineering controls typically reduce exposure at the
source (e.g., by enclosing the process in vessels or pipes, or by local exhaust
ventilation). Prevention of uncontrolled releases is important; this may be
achieved using strategies such as quantity reduction and segregation.
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v. Administrative controls: In general, administrative controls will be required to
supplement higher-level controls. Administrative controls may include
maintenance of equipment and training of workers and their managers in the
operation of the equipment. Preventative maintenance is important in preventing
uncontrolled releases. Work procedures may need to be developed to ensure that
engineering controls function as designed; this includes any safe-handling
procedures and special storage instructions.
vi. Personal protective equipment: Any residual risk may require workers to wear
PPE to reduce exposure to chemicals absorbed through respiration or skin or eye
contact. Specialist knowledge may be required to ensure selection of the correct
type of PPE for a specific chemical. Selection of gloves for protection against
chemicals absorbed through the skin requires reference to chemical resistance
charts or databases and consideration of the potential for chemical permeation,
penetration, and degradation of the PPE. In some situations, chemically resistant
safety footwear is required. Inappropriate or poorly maintained PPE itself can act
as a source of chemical exposure (e.g. contaminated gloves can be a source of
ongoing exposure through persistent permeation or occlusion of the chemical
inside the gloves). While it would be expected that the risk associated with tasks
such as decanting of chemicals would be controlled through the enclosure or
other engineering controls, some chemical handling tasks may require eye
protection. Depending on the task, this may be safety goggles or full face
protection. There is a wide range of PPE for respiratory protection. While
Australian standards provide information on appropriate selection of respirators,
the interpretation of these standards and the selection of the appropriate
respiratory protection require specialist Knowledge. Fitting, maintenance and user
training are important for all types of PPE, but especially for respiratory
protection.
 MANAGEMENT OF COMBUSTIBLE GASES, TOXIC
GASES AND OXYGEN DISPLACING GASES
MANAGEMENT:
Various volatile and flammable liquids used in the chemical industry, vaporize when
exposed to room temperature or above, causing atmospheric pollution. The steam turns
on causing fire accidents and explosions which tend to spread rapidly in the surrounding
environment, causing loss of lives and property. Therefore, the storage and handling of
these hazardous gases require special attention to avoid risks. These can be classified as
follows:
1. Combustible gas:
 Includes gases such as methane (CH4), pentane (C5H12), propane (C3H8), butane
(C4H10), and hydrogen (H2) when released in an installation naturally as a by-
product or leaked, gets ignited when comes in contact with oxygen. This represents
the danger of combustion within a facility if the concentration reaches a certain
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optimum level. Fuel gas detectors are needed when there is a risk of life or property
due to the accumulation of combustible gases. Each type of fuel gas has three
important ranges, and each of these ranges differs for specific gases but uses the
same definitions. Fuel gas concentration is too low for combustion below the lower
explosion limit (LEL) or lower flammable limit. This is the range in which more
fuel gas detectors work
 The upper explosive limit (UEL) or upper flammability limit is the point where the
gas concentration is too rich for combustion, or the oxygen level is too low to
support combustion.
 Between LEL and UEL, concentration (measured as a percentage of air volume)
supports combustion of combustible gas when exposed to a source of ignition. The
flammability of many gases is in a very limited and concentrated range.
2. Toxic gases:
 Toxic gases produce an immediate and persistent hazard to human resources and
include gases such as carbon monoxide, chlorine, nitrogen oxide, sulfur dioxide,
hydrogen chloride, hydrogen cyanide, ammonia, hydrogen fluoride and many others.
They are usually hazardous even at low concentrations and are often characterized in
terms of threshold limit value (TLV).
 Oxygen deficiency In many common working environments, there is the potential
for low oxygen atmospheres due to the gas cylinder and cryogenic exposure.
Cryogenic freezing uses CO2 or liquid N2. Argon is used in inert welding processes.
Environmental chambers and test cells inject liquid nitrogen or use heat
exchangers for rapid cooling.
 Hydrogen is widely used in research for alternative fuel vehicles. Liquid helium
cools superconducting magnets for research and medical imagings such as magnetic
resonance imaging machines. Oxygen depletion can be caused by any of the
following processes such as displacement, combustion, oxidation, chemical reaction,
or bacterial action.
 Cryogenic liquids have huge expansion ratios (460–840 to 1 for those listed), so a
big gas cloud is likely to occur for a little amount of cryogenic liquid. Continuous
monitoring with risk mitigation measures must be used to ensure the safety of
personnel working in the field of gas use or storage. When stationary gas detection is
positioned, it is useful to include hazardous gases dynamics such as ventilation,
stratification or the possible diffusion and gas features. Simple smoke tests can
reveal the essential characteristics of the airflow of the area and greatly simplify the
positioning the level) to protect the staff. When the oxygen concentration drops,
suffocation occurs. OSHA established 19.5%.
 Hazardous gas management
 Compressed gases are filled in cylinders and transported to the place of use.
Important precautions to be taken include the following:
1) The cylinders must not be released or allowed to hit the other.
2) The safety devices installed on the cylinders must not be tampered with..
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3) Use special valves and standard tools. Normally, these are supplied by the
manufacturers.
4) The cylinders must be protected against extremes of weather, especially against
excessive rise in the temperature.
5) The cylinders (receipts) must bear a standard label indicating the type of gas.
The color of the label indicates whether the gas is flammable, corrosive, or
inert.
6) Full cylinders must be separated from the empty ones.
 Components of a gas hazard management system :
A gas monitoring system should provide information to ensure that effective and
complete decisions are made promptly. To be more effective in the management of
gas exposure risks, sufficient information is needed to obtain a thorough assessment
of the situation to make good decisions. Data management is a key element of a gas
hazard management system.
1) Risk assessment: It is the first step in system design. Field studies can help
determine when and where are the hazardous situation and possible exposure.
The hazard characteristics can be determined in terms of ignition, reactivity,
corrosivity, and toxicity. The risk to human health is reflected in the standards
set by the resource conservation and recovery act, OSHA and environmental
protection agency (EPA). The information obtained in a risk assessment
provides a basis for better addressing the risk of identified gas.
2) System specifications and designs: It is the key outcome of the risk management
planning process. The design begins with the selection and position of the
sensor type. Sensor performance should be determined in terms of response
speeds, concentration range, and resolution drift, ease of calibration and
interference gas and must meet the performance criteria set out in the plan.
3) Daily operation: The daily operation of a gas monitoring system focuses on data
revision procedures and system reliability. Automatic self-diagnosis of unit
functions improves reliability by providing a continuous indication of the
operation. Regular maintenance should confirm the internal diagnosis.
4) Alarm response: The alarm response starts with the previous schedule: In the
system and outside the perimeter of the system. Training is essential to ensure
that all staff in the headquarters understand their role and have internalized their
responsibilities. Training includes the identification of false alarms. Relay
action usually involves a low alarm (warning light and siren and ventilation for
gas concentration dilution) and a high alarm (emergency and siren light and
process action). The action of the process involves stopping or isolating the gas
source and stopping the process equipment.
5) Recording: It is an important element of the alarm response. The sensor status
reports provide a valuable reference to assess the severity and magnitude of the
gas hazard. It can generate real-time and post-event analysis. It is the transfer of
information provided by the system to the staff of the plant, which enables
effective gas risk management.
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 REGULATIONS FOR CHEMICAL HAZARD:
 The chemical management relies on a mix of national, regional, and international
mechanisms, a range of multilateral environmental agreement, as well as voluntary
initiatives including a globally harmonized system of classification and labelling of
chemicals, the strategic approach to international chemicals management and
responsible care.
 In many countries, legislative and administrative measures have been introduced to
deal with chemical hazards. In 1992, the United Nations Conference on Environment
and Development (the Rio Earth Conference) gave rise to the Agenda 21 Report 2.
This report outlined the responsibilities of States toward the achievement of
sustainable development and was adopted by heads of Government in over 150
countries. Chapter 19 of Agenda 21 addresses the environmentally sound management
of toxic chemicals for all countries, including basic programs for:
i. Adequate legislation.
ii. Information gathering and dissemination.
iii. Capacity for risk assessment and interpretation.
iv. Establishment of risk management policy.
v. Capacity for implementation and enforcement.
vi. Capacity for rehabilitation of contaminated sites and poisoned persons.
vii. Effective education programs.
viii. Capacity to respond to emergencies. Some international treaties related to
chemical management and India’s participation in them is represented
 The Indian Chemical Industry is poised for growth, and a clearly defined vision has
been developed to enable it. The vision for Indian chemical industry is “To facilitate
the growth and development of the chemical industry in an environmental friendly
manner; with focus on innovation to meet local needs, sustainability, and green
technologies and processes; so as to enable it to become a globally competitive
major-player.”
 The non-regulatory mechanisms adopted by industries in India, in addition to
legislative control, play a very important role in the management of chemicals. Indian
industries take several initiatives for environmental protection and chemical
management, such as responsible care, corporate responsibility in environmental
planning, ISO 14001, OHSAS 18001, ISI Marking (Indian Standards Institution), and
eco-mark. Several awards related to chemical and environmental management are
initiated on voluntary basis by industrial associations, who play an important role in
encouraging industries to go for non-regulatory mechanisms for chemical
management. Important industrial associations include Indian Chemical Council
(formerly, the – Indian Chemical Manufacturer’s Association), Confederation of
Indian Industry, and Federation of Indian Chambers of Commerce and Industry.
 GLOBAL REGULATORY AGENCIES: These are specially related to chemicals,
drugs, and petrochemicals are many and in brief include the following (besides many
more):
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1. US Food and Drug Administration.
2. US EPA.
3. Insecticides Act, 1968. Ministry of Agriculture and Cooperation, Government of
India, and the Environment Protection Act, 1986, India.
4. Pest Management Regulatory Agency (PMRA), Health Canada.
5. PMRA, U.S. EPA.
6. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), United States.
7. National Toxicology Program, United States.
8. National Administration of Drugs, Food, and Medical Technology, Argentina.
9. The European Agency for the Evaluation of Medicinal Products.
10. Federal Institute for Drugs and Medical Devices, Germany.
11. Medicines and Healthcare Products Regulatory Agency, United Kingdom.
12. World Health Organization (WHO), Geneva, Switzerland.
13. International Conference on Harmonization, Geneva, Switzerland.
 INDIAN REGULATORY AGENCIES: The Republic of India enacted several
legislations, rules, and regulations to exercise all the powers vested under the Act and
Rules pertaining to the protection of environment and control of pollution. These are
implemented and enforced in all environment legislation agency activities. The
selected acts and Regulations include, but are not limited to, the following:
1. Drugs and cosmetics act, 1940.
2. The prevention of food adulteration act, 1954.
3. Insecticides act, 1968.
4. The water (prevention and control of pollution) act, 1974.
5. Air (prevention and control of pollution) act, 1981.
6. Narcotic drugs and psychotropic substances act 1985.
7. The environment (protection) act, 1986.
8. Manufacture, storage, and import of hazardous chemicals rules, 1989.
9. Hazardous wastes (management and handling) rules, 1989.
10. Water prevention and control of pollution act, 1974.
11. Hazardous waste (management and handling) rules, 1989.
12. Manufacture, storage and import of hazardous chemical rules, 1989.
13. Rules for manufacture, use, import and storage of hazardous microorganisms,
genetically engineered micro-organism or cells, 1989.
14. Biomedical waste (management and handling) rules, 1998.
15. The recycled plastic manufacture and usage rules, 1999.
16. The ozone-depleting substances (regulation and control) rules, 2000.
17. The noise pollution (regulation and control) rules, 2000.
18. The batteries (management and handling) rules, 2001.
 Our quality of life has significantly improved through chemistry since it has provided
us with various useful products, but this has also provoked global environmental
deprivation and the decline of non-renewable natural resources. Many pollutants end
their path to the food chain global environmental deprivation and the decline of non-
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renewable natural resources. Many pollutants end their path to the food chain and
deteriorate the ecosystem. Green chemistry and change all of these negative aspects
and impacts and through design, innovation, and green practices to restore the
sustainable development. The ultimate goal is to develop and design non-conventional
synthetic for important industrial chemicals to prevent/reduce environmental pollution
 MANAGEMENT OF OVER-EXPOSURE TO
CHEMICALS:
 Removal from Exposure:
 Prompt removal of the person from the exposure site is the first step.
 Air respirators and lifelines are a mandatory first aid.
 Resuscitation :
 Resuscitation means restoration of life of one who is apparently dead (collapsed
or shocked). Further supportive care should be provided as with any other
medical emergency.
 Decontamination:
 A victim whose skin or clothing has been contaminated requires immediate
removal of garments and shoes. Then, vigorous showering with soap and water,
including attention to the fingernails and scalp is advised.
 Symptomatic Treatment:
 Acute overexposure may result in a variety of signs and symptoms that require
general supportive medical management regardless of the specific agent.
Examples include the control of convulsive seizures bronchospasm.
 TLV CONCEPT:
 It is defined as a 15-min, time-weighted average which should not be exceeded at
any time during a working day, even if the 8-h time-weighted average is within the
TLV.
 American Council of Government Industrial Hygienists has established Threshold
Limit Values (TLV).
 TLV-time-weighted average time-weighted average concentration for a normal 8-h
working day and a 40-h working week, to which nearly all workers may be
repeatedly exposed day after day, without adverse effect.
 TLV-short-term exposure limit.
 The workers should not be exposed to the substances more than these limits. TLVs
are only guidelines and are not intended as absolute boundaries between safe and
dangerous concentrations. Every occupational health professional should have a
copy of the current TLV.
 A list of threshold limits (TLV) for about 800 substances has been prepared.
Workers should not be exposed to substances beyond these limits. The following
three TLV categories are specified:
Hazards and Safety Management (MQA201T)
Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi
Page
15
1. TLV-time weighted average (TWA): The TWA for concentration for a normal
daily work of 8 h and 40 h work/week, to which almost all workers can be
exposed several times day after day with no adverse effects.
2. TLV-STEL: Defined as a weighted average of 15 min, this must not be exceeded
at any time during a working day, even if the weighted average of 8 h is within
the TLV. This is the highest concentration where staff can be exposed for short
periods of time without expressing symptoms of irritation, chronic or irreversible
tissue damage or narcosis sufficiently to increase the risk of accident or
essentially reduced efficiency of work.
3. TLV-ceiling: The concentration that must not be exceeded during any part of the
working day. Numerical TLV values do not take into account the toxicity that
may result from skin absorption. It should be emphasized that TLVs are only
guidelines and are not intended to be absolute limits between safe and hazardous
concentrations. Every occupational health professional must have a copy of the
current TLVs and biological exposure indices

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Chemical based hazards word

  • 1. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 1 C CH HE EM MI IC CA AL L B BA AS SE ED D H HA AZ ZA AR RD DS S Prepared by: Dhruvi Parmar 192650824007 M. Pharmacy (Semester II) Hazards and Safety Management (MQA201T)
  • 2. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 2 INDEX Sr.no. CONTENTS 1 Introduction 2 Sources of chemical hazards 3 Hazards of Organic synthesis, sulphonating hazard, Organic solvent hazard 4 Control measures for chemical hazards 5 Management of combustiblegases, Toxic gases and Oxygen displacing gases management 6 Regulations for chemical hazard 7 Management of over-Exposure to chemicals 8 TLV concept 9 Study Questions
  • 3. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 3  INTRODUCTION: A chemical hazard is a type of occupational Hazard caused by exposure to chemicals in the workplace. Exposure to chemicals in the workplace can cause acute or long-term detrimental health effects. HAZARD: Any situation that has potential/ Capability to cause injury/ harm to the worker, damage to the property, Loss/contamination to environment. Hazard is a situation that poses a threat to life, health, property, or the environment. Industrial hazard can be defined as any condition produced by industries that can cause injury or death to personnel or loss of product or property. A chemical hazard is any substance that can cause harm, primarily to people. Chemicals of all kinds are stored in our homes and results in serious injuries if not properly handled. An element or mixture of elements or synthetic substance that are considered harmful to environment is termed as Chemical Hazards.  SOURCE OF CHEMICAL HAZARDS: 1. Ingestion: By swallowing the chemical  Chemicals may be swallowed accidentally if food or cigarettes (or hands) are contaminated. For this reason student and workers should not drink, eeat or smoke in areas where they may be exposed to toxic chemicals. 2. Inhalation: Breathing in the chemical  Chemicals in the air are breathed in through the mouth or nose.  Gases & vapours are absorbed through the lungs directly into the bloodstream  The size of dust particles or mist droplets can affect where the chemical settles in the respiratory tract. 3. Absorption: Penetration of chemical in skin  The chemical soaks through the skin and passes through the skin into the body which enters the bloodstream. 4. Injection:  It can occur when a sharp object (needle) punctures the skin and injects a chemical (or virus) directly into the bloodstream. 5. Air born toxics:  Irritants  Ipecac, podophyllum, etc.  Asphyxiants  Carbon dioxide, monoxide, methane, ethane, and hydrogen cyanide  Hydrogen sulphide, helium, nitrogen, etc.  Narcotics/anaesthetics  Acetone, ether, chloroform, methyl ethyl ketone, etc
  • 4. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 4 6. Carcinogens:  Coal tar, creosote oil, anthracene oil, paraffin oils, and chromium,  Nickel, cobalt, etc.  Hazards may arise when impure or contaminated chemicals are used. 7. Sources of hazards in pharma industry:  Handling and storage of huge quantity hazardous chemicals.  Transferring, loading and unloading of solvents and chemicals to reaction vessels.  Human errors while handling hazardous chemicals.  Emission of hazardous air pollutants from reaction vessels due to overloading or under designed reaction vessels.  Volatile organic compounds (VOCs) releases from uncontained (or not connected to scrubbers).  Reaction vessels and most common VOCs include methanol, dichloromethane, toluene, ethylene glycol, N, n dimethylformamide, and acetonitrile.  Leaks of effluents from wastewater treatment plants or from effluent collection sumps from process area. TYPES OF HAZARDS Chemical hazards are toxic, corrosive, irritant, carcinogenic, flammable, and mutagenic. According to workplace hazardous materials information, chemical hazards are classified as: 1. Class A: • Compressed gas. • Dissolved gas or liquefied gas. 2. Class B: • Flammable gases. • Flammable and combustible liquids. • Flammable solid. • Flammable aerosols. • Reactive flammable material. 3. Class C: • Oxidizing materials: oxidizer and organic peroxide. • Oxidizer: Chlorates, nitric oxide, peroxides, permanganates, perchlorates, nitrites, nitrates, and easily oxidize metal powder. • Organic peroxide: Tetra hydro furan, diethyl ether, dioxane, and methyl isobutyl ether. 4. Class D: • Poisonous and infectious materials. e.g.: Cyanides, tea salts, and asbestos. 5. Class E: • Corrosive materials. e.g.: Inorganic acids and bases, hydrogen fluoride. 6. Class F: • Dangerous reactive materials. e.g.: Ethylene dioxide, organic azides, Na, Li. • Pyrophosphoric materials. e.g.: White phosphorous, diethyl aluminium chloride, and lithium.
  • 5. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 5 HAZARDS OF ORGANIC SYNTHESIS, SULPHONATING HAZARD, ORGANIC SOLVENT HAZARD: 1. The hazards of organic synthesis:  Organic chemical synthesis presents industrial hazards of three main types. First, the active agents used to attack and modify the structure of organic compounds are, by their very nature, exceptionally able to attack and modify the organic compounds of the human body, thus producing highly poisonous effects. Second, the intermediate compounds in most organic syntheses are often characterized by the readiness with which they enter into chemical combination with other organic matter; they are active. This often confers toxic properties of great variety on them. Third, the final products, though they are medicines designed to be introduced into the human body, may nevertheless produce severe poisoning under conditions of industrial exposure. 2. Sulfonating Agents  The Sulfonating agents, chlorosulfonic acid (HOSO2CI) are extensively used in the manufacture of p-acetyl amino benzene sulfonyl chloride. The fumes of the acid itself are highly irritating, and in many sulfonation reactions, HCI gas and SO2 are given off. It is often not economically feasible to trap these irritant by-products in a small synthesis, and they are often vented into the outside air. This is a bad practice, which will cause a large amount of bronchitis and conjunctivitis under adverse wind
  • 6. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 6 and weather conditions. Scrubbing towers of simple and cheap design, or very high stacks, are usually required to eliminate the nuisance. 3. Final Products of Synthesis i. Mepacrine and acriflavine  Among the final products of organic synthesis, mepacrine itself deserves mention as an especially troublesome primary irritant and sensitizer. Rather extensive compressing and grinding, thrice repeated, are necessary to prepare the material in the form of tablets; dust control during these operations is mandatory, but extremely difficult, because of the structure of the machines involved. In a study made at the Abbott Laboratories (Watrous, 1944), exposure to the dust at levels between 035 and 4–2 µg/l was sufficient to cause conjunctivitis in more than half of the workmen, and dermatitis, rhinitis, and stomatitis in about a third. Similar symptoms have recently been described by Barlow et al. (1946). Acriflavine another dye of the acridine series, possesses similar, though weaker, irritant properties; workers bottling tablets of this dye often suffer from a conjunctivitis of considerable severity if they transfer the material to their eyes by injudicious rubbing with dust-stained hands. ii. Nicotinic acid  Nicotinic acid and its salts have a peculiar effect on the skin of certain workers who handle these chemicals in bulk: This consists of a diffuse erythema on the exposed parts of the skin, usually not accompanied by itching, and resembling sunburn in appearance. It is usually transient, disappearing in from 12 to 24 h, though sometimes it assumes a popular character on the 2nd day and lasts several days. iii. Powdered penicillin  Dry powdered penicillin has proved to be a potent sensitizer and skin irritant in all the American factories where it is handled. It may produce follicular erythema, diffuse; popular rashes on the exposed parts of the body, or, in some cases, severe generalized urticaria which persists for days or weeks after exposure ceases. In the latter cases, it seems probable that a generalized sensitivity has been created by the previous contact with the substance, and that the urticaria results from systemic absorption of the powdered drug by inhalation. In a series of four cases showing industrial dermatitis from exposure to penicillin, Friedlaender et al. (1946) found the patients to be sensitive to pure crystalline penicillin rather than to any particular impurity in the commercial product. iv. Local anesthetics  The local anesthetics, procaine, butyl (butacaine sulfate), and butesin (n-butyl amino benzoate), form a group of substances more or less prone to cause sensitization and dermatitis on prolonged contact with the skin. The tendency for procaine to sensitize the skin of dentists and others who frequently spilled solutions on their hands were recognized many years ago and was one of the factors which made prepared solutions in cartridges so popular with dentists.
  • 7. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 7 Women engaged in filling cartridges with sterile solutions of procaine are subject to a characteristic occupational dermatitis caused by excess solution overflowing from the tubes and running down their arms. v. Neoarsphehamine  Neoarsphenamine, sensitization of the skin in those who pack it in ampoules. In such cases, the minute amount of dust which settles on the skin during the process may cause popular rashes on the exposed skin areas. In one such case, the skin was so sensitive to contact with the drug that a patch test made with a few milligrams of the powder exhibited vesiculation within 12 h. Such marked reactions, however, are rare; patch tests are usually negative, but many mild dermatoses of this kind subside when contact with the drug ceases and recur when it is resumed. Neoarsphenamine may also act as a primary irritant if it is allowed to accumulate under the nails of those handling it. vi. 2-methyl-1, 4-naphthoquinone  2-methyl-1, 4-naphthoquinone, a synthetic form of Vitamin K, has the property of sensitizing the skin and producing dermatitis. Workers who handle this chemical present a dark-brown staining of the skin, and may later show popular or eczematoid dermatitis. vii. Sulfonechloramides  At least two Sulfonechloramides which are used as antiseptics or disinfectants have rather unusual properties as local irritants and sensitizers. When these chemicals contaminate the working environment in the form of dust, they may produce dermatitis, rhinitis, conjunctivitis, and bronchitis in their capacity as primary irritants. viii. Solvents  Methyl alcohol is not commonly used. Ethyl alcohol offers medical hazards only to the extent to which it is denatured with more toxic materials. ix. Benzene  Benzene itself is, unfortunately, such an excellent solvent for many active principles, as well as for numerous important synthetic chemicals, that it constitutes a major problem in the pharmaceutical industry. This is not the place to describe or discuss the well-known facts about acute and chronic benzene poisoning, except to affirm from my own experience that these well-established facts are still completely unknown or disregarded in more backward works, and that they cry out for more popular diffusion among workmen and foremen, even in the most progressive organizations. x. Chloroform and ethylene dichloride  Chloroform and ethylene dichloride (1,2-dichloroethane) are occasionally used to extract alkaloids and other fat soluble principles. Both solvents are liver poisons, and men working with them under ordinary conditions may develop certain vague symptoms which are referable to the gastrointestinal tract and which suggest very slight liver damage. These consist of anorexia, a heavy feeling in the epigastrium, and fatigue. At this time the urine may give a positive test for urobilinogen, and in my experience, this is an indication for transferring
  • 8. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 8 the workman temporarily to other employment. By-products may accumulate relatively high concentrations in parts of the plant and cause unexpected effects. In pharmaceutical industry, most of the dermatitis can be attributed to synthetic drugs, especially acridine and phenothiazines.  CONTROL MEASURE FOR CHEMICAL HAZARDS:  The next three sections (a planner’s Guide, A Supervisor’s Guide, and A Worker’s Guide) Provide detailed information on the roles and responsibilities in developing and implementing effective chemical management, based on the phase in which each person fits (i.e., planning, implementation, or execution). Each section serves as a standalone guide for each phase.  Use the following descriptions to select the section that best applies to your role in the process: i. A planner’s guide (blue) is for those persons (planners) responsible for planning and initially designing the chemical management process. Planning roles include but are not limited to prime contractor, owner, owner’s representative, licensee, operator, and supplier. ii. A supervisor’s guide (red) is for those persons (implementers/supervisors) responsible for organizing workers and ensuring that the chemical management process gets done. Implementation roles include but are not limited to supplier, supervisor, and site supervisor. iii. A worker’s guide (green) is for those persons (executers/workers) who physically manage the chemicals on the job site and therefore are directly or indirectly exposed to the chemicals. Execution roles include but are not limited to supervisor, worker, and driver.  Control of Chemical Hazards: Priorities for control action i. Elimination: The most effective and reliable controls are those that result in the elimination of the hazardous chemical. ii. Substitution: Substitution of a hazardous chemical for a less hazardous one is the next control of choice; however, care must be taken to ensure that the substituted chemical does not introduce new hazards. Substitution also may involve using the chemical in a less hazardous form or process (e.g., use of the chemical in a pellet form rather than a dust). iii. Isolation: Isolation of the chemical in time or space from those potentially exposed can be an effective means of control (e.g., locating people in a protected control room, installing a buffer area around a chemical reactor, using the material when people are not in the vicinity). iv. Engineering controls: Engineering controls typically reduce exposure at the source (e.g., by enclosing the process in vessels or pipes, or by local exhaust ventilation). Prevention of uncontrolled releases is important; this may be achieved using strategies such as quantity reduction and segregation.
  • 9. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 9 v. Administrative controls: In general, administrative controls will be required to supplement higher-level controls. Administrative controls may include maintenance of equipment and training of workers and their managers in the operation of the equipment. Preventative maintenance is important in preventing uncontrolled releases. Work procedures may need to be developed to ensure that engineering controls function as designed; this includes any safe-handling procedures and special storage instructions. vi. Personal protective equipment: Any residual risk may require workers to wear PPE to reduce exposure to chemicals absorbed through respiration or skin or eye contact. Specialist knowledge may be required to ensure selection of the correct type of PPE for a specific chemical. Selection of gloves for protection against chemicals absorbed through the skin requires reference to chemical resistance charts or databases and consideration of the potential for chemical permeation, penetration, and degradation of the PPE. In some situations, chemically resistant safety footwear is required. Inappropriate or poorly maintained PPE itself can act as a source of chemical exposure (e.g. contaminated gloves can be a source of ongoing exposure through persistent permeation or occlusion of the chemical inside the gloves). While it would be expected that the risk associated with tasks such as decanting of chemicals would be controlled through the enclosure or other engineering controls, some chemical handling tasks may require eye protection. Depending on the task, this may be safety goggles or full face protection. There is a wide range of PPE for respiratory protection. While Australian standards provide information on appropriate selection of respirators, the interpretation of these standards and the selection of the appropriate respiratory protection require specialist Knowledge. Fitting, maintenance and user training are important for all types of PPE, but especially for respiratory protection.  MANAGEMENT OF COMBUSTIBLE GASES, TOXIC GASES AND OXYGEN DISPLACING GASES MANAGEMENT: Various volatile and flammable liquids used in the chemical industry, vaporize when exposed to room temperature or above, causing atmospheric pollution. The steam turns on causing fire accidents and explosions which tend to spread rapidly in the surrounding environment, causing loss of lives and property. Therefore, the storage and handling of these hazardous gases require special attention to avoid risks. These can be classified as follows: 1. Combustible gas:  Includes gases such as methane (CH4), pentane (C5H12), propane (C3H8), butane (C4H10), and hydrogen (H2) when released in an installation naturally as a by- product or leaked, gets ignited when comes in contact with oxygen. This represents the danger of combustion within a facility if the concentration reaches a certain
  • 10. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 10 optimum level. Fuel gas detectors are needed when there is a risk of life or property due to the accumulation of combustible gases. Each type of fuel gas has three important ranges, and each of these ranges differs for specific gases but uses the same definitions. Fuel gas concentration is too low for combustion below the lower explosion limit (LEL) or lower flammable limit. This is the range in which more fuel gas detectors work  The upper explosive limit (UEL) or upper flammability limit is the point where the gas concentration is too rich for combustion, or the oxygen level is too low to support combustion.  Between LEL and UEL, concentration (measured as a percentage of air volume) supports combustion of combustible gas when exposed to a source of ignition. The flammability of many gases is in a very limited and concentrated range. 2. Toxic gases:  Toxic gases produce an immediate and persistent hazard to human resources and include gases such as carbon monoxide, chlorine, nitrogen oxide, sulfur dioxide, hydrogen chloride, hydrogen cyanide, ammonia, hydrogen fluoride and many others. They are usually hazardous even at low concentrations and are often characterized in terms of threshold limit value (TLV).  Oxygen deficiency In many common working environments, there is the potential for low oxygen atmospheres due to the gas cylinder and cryogenic exposure. Cryogenic freezing uses CO2 or liquid N2. Argon is used in inert welding processes. Environmental chambers and test cells inject liquid nitrogen or use heat exchangers for rapid cooling.  Hydrogen is widely used in research for alternative fuel vehicles. Liquid helium cools superconducting magnets for research and medical imagings such as magnetic resonance imaging machines. Oxygen depletion can be caused by any of the following processes such as displacement, combustion, oxidation, chemical reaction, or bacterial action.  Cryogenic liquids have huge expansion ratios (460–840 to 1 for those listed), so a big gas cloud is likely to occur for a little amount of cryogenic liquid. Continuous monitoring with risk mitigation measures must be used to ensure the safety of personnel working in the field of gas use or storage. When stationary gas detection is positioned, it is useful to include hazardous gases dynamics such as ventilation, stratification or the possible diffusion and gas features. Simple smoke tests can reveal the essential characteristics of the airflow of the area and greatly simplify the positioning the level) to protect the staff. When the oxygen concentration drops, suffocation occurs. OSHA established 19.5%.  Hazardous gas management  Compressed gases are filled in cylinders and transported to the place of use. Important precautions to be taken include the following: 1) The cylinders must not be released or allowed to hit the other. 2) The safety devices installed on the cylinders must not be tampered with..
  • 11. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 11 3) Use special valves and standard tools. Normally, these are supplied by the manufacturers. 4) The cylinders must be protected against extremes of weather, especially against excessive rise in the temperature. 5) The cylinders (receipts) must bear a standard label indicating the type of gas. The color of the label indicates whether the gas is flammable, corrosive, or inert. 6) Full cylinders must be separated from the empty ones.  Components of a gas hazard management system : A gas monitoring system should provide information to ensure that effective and complete decisions are made promptly. To be more effective in the management of gas exposure risks, sufficient information is needed to obtain a thorough assessment of the situation to make good decisions. Data management is a key element of a gas hazard management system. 1) Risk assessment: It is the first step in system design. Field studies can help determine when and where are the hazardous situation and possible exposure. The hazard characteristics can be determined in terms of ignition, reactivity, corrosivity, and toxicity. The risk to human health is reflected in the standards set by the resource conservation and recovery act, OSHA and environmental protection agency (EPA). The information obtained in a risk assessment provides a basis for better addressing the risk of identified gas. 2) System specifications and designs: It is the key outcome of the risk management planning process. The design begins with the selection and position of the sensor type. Sensor performance should be determined in terms of response speeds, concentration range, and resolution drift, ease of calibration and interference gas and must meet the performance criteria set out in the plan. 3) Daily operation: The daily operation of a gas monitoring system focuses on data revision procedures and system reliability. Automatic self-diagnosis of unit functions improves reliability by providing a continuous indication of the operation. Regular maintenance should confirm the internal diagnosis. 4) Alarm response: The alarm response starts with the previous schedule: In the system and outside the perimeter of the system. Training is essential to ensure that all staff in the headquarters understand their role and have internalized their responsibilities. Training includes the identification of false alarms. Relay action usually involves a low alarm (warning light and siren and ventilation for gas concentration dilution) and a high alarm (emergency and siren light and process action). The action of the process involves stopping or isolating the gas source and stopping the process equipment. 5) Recording: It is an important element of the alarm response. The sensor status reports provide a valuable reference to assess the severity and magnitude of the gas hazard. It can generate real-time and post-event analysis. It is the transfer of information provided by the system to the staff of the plant, which enables effective gas risk management.
  • 12. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 12  REGULATIONS FOR CHEMICAL HAZARD:  The chemical management relies on a mix of national, regional, and international mechanisms, a range of multilateral environmental agreement, as well as voluntary initiatives including a globally harmonized system of classification and labelling of chemicals, the strategic approach to international chemicals management and responsible care.  In many countries, legislative and administrative measures have been introduced to deal with chemical hazards. In 1992, the United Nations Conference on Environment and Development (the Rio Earth Conference) gave rise to the Agenda 21 Report 2. This report outlined the responsibilities of States toward the achievement of sustainable development and was adopted by heads of Government in over 150 countries. Chapter 19 of Agenda 21 addresses the environmentally sound management of toxic chemicals for all countries, including basic programs for: i. Adequate legislation. ii. Information gathering and dissemination. iii. Capacity for risk assessment and interpretation. iv. Establishment of risk management policy. v. Capacity for implementation and enforcement. vi. Capacity for rehabilitation of contaminated sites and poisoned persons. vii. Effective education programs. viii. Capacity to respond to emergencies. Some international treaties related to chemical management and India’s participation in them is represented  The Indian Chemical Industry is poised for growth, and a clearly defined vision has been developed to enable it. The vision for Indian chemical industry is “To facilitate the growth and development of the chemical industry in an environmental friendly manner; with focus on innovation to meet local needs, sustainability, and green technologies and processes; so as to enable it to become a globally competitive major-player.”  The non-regulatory mechanisms adopted by industries in India, in addition to legislative control, play a very important role in the management of chemicals. Indian industries take several initiatives for environmental protection and chemical management, such as responsible care, corporate responsibility in environmental planning, ISO 14001, OHSAS 18001, ISI Marking (Indian Standards Institution), and eco-mark. Several awards related to chemical and environmental management are initiated on voluntary basis by industrial associations, who play an important role in encouraging industries to go for non-regulatory mechanisms for chemical management. Important industrial associations include Indian Chemical Council (formerly, the – Indian Chemical Manufacturer’s Association), Confederation of Indian Industry, and Federation of Indian Chambers of Commerce and Industry.  GLOBAL REGULATORY AGENCIES: These are specially related to chemicals, drugs, and petrochemicals are many and in brief include the following (besides many more):
  • 13. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 13 1. US Food and Drug Administration. 2. US EPA. 3. Insecticides Act, 1968. Ministry of Agriculture and Cooperation, Government of India, and the Environment Protection Act, 1986, India. 4. Pest Management Regulatory Agency (PMRA), Health Canada. 5. PMRA, U.S. EPA. 6. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), United States. 7. National Toxicology Program, United States. 8. National Administration of Drugs, Food, and Medical Technology, Argentina. 9. The European Agency for the Evaluation of Medicinal Products. 10. Federal Institute for Drugs and Medical Devices, Germany. 11. Medicines and Healthcare Products Regulatory Agency, United Kingdom. 12. World Health Organization (WHO), Geneva, Switzerland. 13. International Conference on Harmonization, Geneva, Switzerland.  INDIAN REGULATORY AGENCIES: The Republic of India enacted several legislations, rules, and regulations to exercise all the powers vested under the Act and Rules pertaining to the protection of environment and control of pollution. These are implemented and enforced in all environment legislation agency activities. The selected acts and Regulations include, but are not limited to, the following: 1. Drugs and cosmetics act, 1940. 2. The prevention of food adulteration act, 1954. 3. Insecticides act, 1968. 4. The water (prevention and control of pollution) act, 1974. 5. Air (prevention and control of pollution) act, 1981. 6. Narcotic drugs and psychotropic substances act 1985. 7. The environment (protection) act, 1986. 8. Manufacture, storage, and import of hazardous chemicals rules, 1989. 9. Hazardous wastes (management and handling) rules, 1989. 10. Water prevention and control of pollution act, 1974. 11. Hazardous waste (management and handling) rules, 1989. 12. Manufacture, storage and import of hazardous chemical rules, 1989. 13. Rules for manufacture, use, import and storage of hazardous microorganisms, genetically engineered micro-organism or cells, 1989. 14. Biomedical waste (management and handling) rules, 1998. 15. The recycled plastic manufacture and usage rules, 1999. 16. The ozone-depleting substances (regulation and control) rules, 2000. 17. The noise pollution (regulation and control) rules, 2000. 18. The batteries (management and handling) rules, 2001.  Our quality of life has significantly improved through chemistry since it has provided us with various useful products, but this has also provoked global environmental deprivation and the decline of non-renewable natural resources. Many pollutants end their path to the food chain global environmental deprivation and the decline of non-
  • 14. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 14 renewable natural resources. Many pollutants end their path to the food chain and deteriorate the ecosystem. Green chemistry and change all of these negative aspects and impacts and through design, innovation, and green practices to restore the sustainable development. The ultimate goal is to develop and design non-conventional synthetic for important industrial chemicals to prevent/reduce environmental pollution  MANAGEMENT OF OVER-EXPOSURE TO CHEMICALS:  Removal from Exposure:  Prompt removal of the person from the exposure site is the first step.  Air respirators and lifelines are a mandatory first aid.  Resuscitation :  Resuscitation means restoration of life of one who is apparently dead (collapsed or shocked). Further supportive care should be provided as with any other medical emergency.  Decontamination:  A victim whose skin or clothing has been contaminated requires immediate removal of garments and shoes. Then, vigorous showering with soap and water, including attention to the fingernails and scalp is advised.  Symptomatic Treatment:  Acute overexposure may result in a variety of signs and symptoms that require general supportive medical management regardless of the specific agent. Examples include the control of convulsive seizures bronchospasm.  TLV CONCEPT:  It is defined as a 15-min, time-weighted average which should not be exceeded at any time during a working day, even if the 8-h time-weighted average is within the TLV.  American Council of Government Industrial Hygienists has established Threshold Limit Values (TLV).  TLV-time-weighted average time-weighted average concentration for a normal 8-h working day and a 40-h working week, to which nearly all workers may be repeatedly exposed day after day, without adverse effect.  TLV-short-term exposure limit.  The workers should not be exposed to the substances more than these limits. TLVs are only guidelines and are not intended as absolute boundaries between safe and dangerous concentrations. Every occupational health professional should have a copy of the current TLV.  A list of threshold limits (TLV) for about 800 substances has been prepared. Workers should not be exposed to substances beyond these limits. The following three TLV categories are specified:
  • 15. Hazards and Safety Management (MQA201T) Smt BNB Swaminarayan Pharmacy College, Salvav, Vapi Page 15 1. TLV-time weighted average (TWA): The TWA for concentration for a normal daily work of 8 h and 40 h work/week, to which almost all workers can be exposed several times day after day with no adverse effects. 2. TLV-STEL: Defined as a weighted average of 15 min, this must not be exceeded at any time during a working day, even if the weighted average of 8 h is within the TLV. This is the highest concentration where staff can be exposed for short periods of time without expressing symptoms of irritation, chronic or irreversible tissue damage or narcosis sufficiently to increase the risk of accident or essentially reduced efficiency of work. 3. TLV-ceiling: The concentration that must not be exceeded during any part of the working day. Numerical TLV values do not take into account the toxicity that may result from skin absorption. It should be emphasized that TLVs are only guidelines and are not intended to be absolute limits between safe and hazardous concentrations. Every occupational health professional must have a copy of the current TLVs and biological exposure indices