E665
October 25, 2002
CAPACITY BUILDING PROJECT ON FOOD SAFETY AND
QUALITY CONTROL OF DRUGS
ENVIRONMENTAL MANGEMENT PLAN
'4c4q 4 W-
GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
DEPARTMENT OF HEALTH
OCTOBER 2002
Environment Plan, 25 Oct, 02
FI.LE GOR^Y



;AT,                 0
FILE (S)
No. CBP/ENVIRONMENT/2002
Govt. of India              ACTION BY
Ministry of Health and Family Welfare
Department of Health           COPY TO
Nirman Bhawa l, New Delhi
To                                                Do ted 25.10.02   Ana
C!tm.s Fibo.-
Dr G.N.V Ramana, 
Sr Public Health Specialist,                                             w
World Bank,
70, Lodi Estate
New Delhi
Subject: - Environmental Management Plan for Capacity Buwldmg Project
on Food Safety and Quahty Control of Drugs.
SLr,
I am forwarding a copy of the Environmental Management Plan for
Capacity Building Project on Food Safety and Quality Control of Drugs for
your review
The Govt of India has no objection to the disclosure of these documents at
the Bank, Public Information Centre The Environmental Plan wdl also be
downloaded on the Ministry's website. A copy of the plan is also being
shared with the participating States
The budget for addressing the Environmental Issues has been estimated at
Rs. 1.05 Millions. However, this will be suitably enhanced if durmg
implementation of the plan further provision of funds, or new activities, are
required
Yours faithfully,
(Deepak- Gupta)
Joint Secretary



1. Background
1.1. Introduction
The Government of India is strongly committed to improving the quality and safety of food and
drugs in the country. The long term strategy includes creating common standards and approaches
in the country and policy reforms related to existing government regulations, licensing,
transparency and enforcement. A number of initiatives have been taken in last few years to
improve the capacity of testing laboratones and to upgrade systems and procedures. To further
support this exercise and to disseminate it umformly across all states in the country, the Ministry
of Health and Family Welfare (MOHFW) of the Government of India has proposed the Food and
Drug Capacity Buildmg Project, to the World Bank.
One of the keys areas proposed within the Food and Drug Capacity Buildmg project relates to the
upgradation of capacity and competency of the Central and State Food and Drugs testing
laboratories. At the policy level, the project will allow the enhancement of the existmg set of laws
and regulatory provisions to clearly and specifically address the handlmg and management of
hazardous chemicals and biohazardous wastes used and generated In such Drug and Food Testing
Laboratories An environmental management action plan will be implemented to minumize
negative environmental impacts of current and future operations and to increase the overall safety
at these laboratones. The project will allow for the enhanicemenit of the existing national Good
Laboratory Practices (GLP) Guidelines with an environmental management health and safety
component and standard Codes of Practice.
The food and drug-testing laboratory undertake analytical work involving use of vanous
chemicals though the quantities used are small. The chemical waste generated is mmimal and the
only risk may be created by occasional spillage, splashes or broken glassware
1.2. Objectives
The main objective is the development and implementation of a generic Environmental
Management Action Plan which will enable review and mitigation of environmental nsks related
to the up-gradation, construction and operation of laboratones, in a manner to ensure compliance
with environmental requirements in India and compatibility with the mternational environmnental
practices.
1.3. Methodology
i)    The MOHFW did a preliminary desk review of laboratories to be covered under this
project Site visits to followmg 4 food and drug controt laboratories were undcrtaken
* Food Research & Standardisation laboratory, Gaziabad (UP)
* Central Indian Pharmacopuer laboratory, Rajnagar ( UP)
*  National Institute of Biologicals, Noida (UP)
*  Central drug research institute, Kasauli (HP)
ii)   Consultations were held with the key stakeholders mcluding MOHFW and laboratory
staff, food anid drug regulatory personnel, environmental NGOs and the affected
communities.
iii)  The MOHFW did a desk review of the existing policy framework for environmental
protection and occupational safety and health in food and drug laboratories, which
included the following
existmg legislations in India mcludmg (a) Biomedical Waste (Management and
Handlmig) Ruies-1998; (b) Environment Protection Act - 1986; (c) The Factones
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existng legislations in India including (a) Biomedical Waste (Management and
Handling) Rules-1998; (b) Environment Protection Act - 1986; (c) The Factones
Act - 1948, and (d) Drugs and Cosmetics Act, (e) The Manufacture, Storage, and
Import of Hazardous Chemical Rules (1989) and (f)    Hazardous Wastes
(Management and Handling) Rules (1989)
*  mtemational legislations and guidelines mcluding WHO documents
*  Good Laboratory Practices (GLP) guidelmes for Drug Quality Testmg Laboratones
developed by MOBIFW
*  Critena for Laboratory Accreditation, National Accreditations Board for Testing
and Calibration of laboratones, Department of Science and Technology
2.   Situation Analysis
2.1    The site visits and stakeholder consultations revealed the following.
* Most of the laboratories are small, with few workers with minimal amount of materials
usage and waste generation
* The volume of waste generated is small, but varied due to the different types of chemicals
used. Combined waste water parameters vary from laboratory to laboratory
* There is lack of awareness regarding waste management and in most laboratories, there is
no proper segregation of waste
* Laboratones do not keep records of quantity and quality of waste generated
• Wastewater audit and monitoring systems are lacking
*  There are some basic standards for safe management of hazardous chemical matenals and
wastes
* Better operational practices and segregation at source can reduce waste generation.
*  There is need to enhance the skills and capacity of most laboratory staff in environmental
health and safety management
* There is need for updating, standardizing and enforcing existing laws and improved
coordination with regulatory agencies
2.2    Review of National legal and regulatory frameworks
2.2.1  The Environmental (Protection) Act, 1986
This Act is designed to protect environment from air and water pollution The Act has provisions
to prevent contamination of soil from improper hazardous waste disposal and from leakage, spills
or leaching of chemicals. This Act categorically mentions effluent discharge standards for
different categories of industries.
While there are general standards for discharge of environmental pollutants m Inland surface
water, public sewer, land and marine in Schedule-lof the Act, there are no separate standards
mentioned for food and drug control laboratories.
2.2.2 The Biomedical Waste (Management and Handling) Rules (1998)
These rules, which were partly amended in 2000, apply to all persons who generate, collect,
receive, store, transport, treat, dispose, or handle biomedical waste m any form. Bio-medical
waste is defined as any waste, which is generated during the diagnosis, treatment or immunization
of human beings or aniimals or in research activities pertaimng thereto or in the production or
testmg of biological, and including categories mentioned in Schedule I Schedule I describes the
different categories of biomedical waste as detailed below.-
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SCHEDULE I
CATEGORIES OF BIOMEDICAL WASTES
Option                         Waste Category                       Treatment & Disposal
Category No 1   Human Anatomical Waste                               Incineration'/deep bunal2
(Not            (human tissues, organs, body parts)
Apphcable)
Category No. 2  Ammal Wastes                                         Incuieration'/deep bunal2
(animal tissues, organs, body parts carcasses, bleeding
parts, fluid, blood and expenrmental ammals used in
research, waste generated by veterinary hospitals,
discharge from hospitals, animal houses)
Category No. 3  Microbiology and Biotechnology Waste
(wastes from laboratory cultures, stocks or specimens of local autoclaving/
micro-organisms, live or attenuated vaccines, human and  microwaving/incineration
animal cell culture used in research and infectious agents
from research and industrial laboratories, wastes from the
production of biologicals, toxins, dishes and devices used
for the transfer of cultures)
Category No. 4  Waste Sharps                                         disinfections (chemical
(needles, syringes, scalpels, blades, glass, etc, that may  treatment3)/autoclaving/
cause puncture or cuts. This includes both used and  microwave/& mutilation/
unused sharps)                                       shredding4
Category No. 5  Discarded Medicines and Cytotoxic Drugs              mcineration'/destruction
(wastes comprismg outdated, contaminated and discarded  and drugs disposed m
medicines)                                           secured landfills
Category No. 6  Soiled Waste (items contaminated with blood and body
fluids including cotton dressings, soiled plaster casts, incineration'/autoclaving/m
lines, beddings, other matenal contaminated with blood)  icrowavmg
Category No. 7  Solid Waste (wastes generated from disposable items, disinfections (chemical
other than waste sharps, such as tubmgs, catheters, treatment3)/autoclaving/
intravenous sets, etc)                               microwave/& mutilation/
shredding4
Category No. 8  Liquid Waste                                         disinfections (chemical
(waste generated from laboratory and washmg, cleaning, treatment3) and discharge
housekeeping and dismnfecting activities)            into drains
Category No 9   Incmeration Ash                                      disposal in municipal
(Not            (ash from incineration of any biomedical waste)      landfill
applicable)
Category No 10  Chemical Waste                                        disinfections (chemical
(chemicals used in production of biologicals, chemicals treatment3)and discharge
used m disinfection, as insecticides, etc)           into drams for hquids and
I secured landfill for solids
l There will no chemical pretreatment before incineration. Chlorinatedplastics shall not be incinerated
2Deep burial shall be an opton available only in towns with populanon less tian five lakhs and in rural
areas
3Chemicals treatment using at least 1% hypo chlonte solution orany other equivalent chemical reagent
It must be ensured that chemical treatment ensures disinfections
4Mutilation/shredding must be such so as to prevent unauthorized reuse.
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Food and Drug Testing Laboratories are likely to produce wastes m many of the 10 categories
listed above The correct classification and proper segregation of biomedical wastes (hazardous
and non-hazardous general wastes) is essential and should be the responsibilitv of the staff of the
laboratory.
The Biomedical Waste Rules do not cover safety, traning and occupational health aspects of the
food and drug laboratories.
2.2.3 TheHazardous Wastes (Management and Handling) Rules (1989)
These regulations include requirements governing waste classification, accumulation, disposal.
record-keepung and emergency preparedness. Hazardous waste management requirements are
dependent upon the type and quantity of vastes generated by the laboratones. Most laboratones
generate hazardous waste and, therefore, are subject to these rules The Rules specify hazardous
waste in 10 categories and regulatory quantities are indicated for each category.
These Rules do not specifically mention the hazardous waste generated m food and drug testing
laboratories.
2.2.4 T7heManufacture, Storage and lmport of Hazardous Chemical Rules (1989) -
The rules address storage and handling of flammable liquids and of compressed gases and
communicating chemical hazards in the laboratones The rules require the communication of all
chemical hazards to employees in the laboratories
These rules do not address the handlmg of hazardous chemicals with reference to their
transportation and movement.
2.2.5 The Factories Act, 1948
This law specifically focuses on occupational health and safety and identifies the need for
Material Safety Data Sheets (MSDS).
The basic provisions for safe workplace provided for under this Act can be applied as a baseline,
but needs to be updated to reflect current understanding of health and safety issues and the myriad
of new chemicals in use in manufacturing and the food and drug industry
2.2.6  Drugs and Cosmetics Ac & Rules
The provisions under this Act are applicable to drug manufacturng units and provide guidelines
on 'good manufacturing practices'.
But this Act does not mention enviromnental plans or have any significant reference on health
and safcty in thc laboratories. There is a passing reference to first aid, but with no details
22.7 Good Laboratory Practices (GLP), MOHFW
The GLP Guidelines for Drug Tcstmg Laboratones focuses on procedures, practices, techmnques
of drug testing. The GLP guidelines do not cover the food labs
The National Accreditation Board for Testing and Calibration Laboratones (NABL) establishes
cnteria for laboratory accreditation The focus is on mamtaining good environmental conditions
related to standards for accuracy of testing
The GLP and accreditation standards for laboratories do not contain guidelnes for environmental
management of Food and Drug Testng Laboratories.
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2.2.8  Conclusion
Though the existing laws m India have established standards on occupational health, safety. waste
management and general environmental protection for manufacturing units, they do not provide
specifically for environmental health and safety in Drug and Food quality testing laboratones
Laboratones present unique working conditions, even though the quantities of chemicals used
and amount of wastes generated are relatively small. The disposal of hazardous chemicals, empty
contamers and bottles and wastewater are issues which need to be addressed since mdiscrinmate
use, storage, handling and disposal can have senous implications for the health of the public and
of the environment.
2.3. Review of International Guidelines
2.3.1 Safe Management of wastes from health-care activities (1999), WHO
While the focus of this guideline is on establishments providing direct health care scrvices, much
of the material on chemical wastes and bio-hazardous waste management would be applicable or
could be adapted to address similar wastes in laboratories
In particular this would be useful in Sharps Management Guidelmes, General guidelines for large
and small facility waste planning and Chemical waste / laboratory waste sections
2.3.2 Environmental Management Gutide for Small Laboratories, May 2000 - United States
Environmental Protection Agency:
This guide provides a specific approach to envuronmental management systems, and is designcd
for laboratories m the U.S and elsewhere that typically do not have a person employed as an
environmental manager. These laboratories include research laboratones for healthcare, and
those that do commercial testing for healthcare, food, mdustrial hygiene, waste
This guide, with its emphasis on designing systems and supportmg pollution prevention, make it
an ideal resource to establish a national guide for GEMPL (Good Environmental Management
Practices in Laboratones).
2.3.3. Manuals on health and safety guidelines for laboratories: National Institute of
Environmental Health Sciences (NIEHS), USA
While these manuals focus on larger laboratories, elements of some of the guidelines may be
appropriate to extract for reference in the Food and Dnig laboratones.
2.3.4. Laborator yProcedures Manual, US. Food and Drug Administration (FDA)
This manual is designed for field laboratones and mav be an appropriate reference tool It
focuses on worker safeguards against laboratory hazards (biologlcal and chemical) Such worker
safety practices are also generally appropriate anid aligned with environmental safeguards.
2.3.5. Conclusion:
Some of the interational standards may not be appropnate to conditions in Indian laboratonrs
However, some of the manuals, in particular those from FDA and EPA, are directed to smaller
laboratories. which could probably be rephcated in many of the state laboratones under the
framework of this program. The MOHFW considers that such mternational guides provide good
reference materials and a basis for developing specific manuals and protocols for the food and
drug laboratories
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3. Environmental Impacts
The proper identification of the environnental impacts related to laboiatory operation and
construction activities is important so as to dcfinc effective mitigation and management practices
This has a beneficial effect not onlv on overall environmental performance but also on the safety
and health of the laboratory personnel and related communitv.
Laboratories present umque workmg conditions and envirornent even though the quantitv of
chemicals used is small. Even chemicals that are generally considered to be benign have the
potential to be hazardous under specific circumstances
3.1 Environmental Impacts related to Laboratory Construction
Somc of thc cnvironmental impacts associated xvith laboratory construction arc hsted below
3.1.1 Water Pollution
Construction activitics generatc waste water from wash-pits, whcel washing, equipment clcaling,
etc which can be a source of water pollution if the drainage system is ineffective Additionallv the
large ntumber of temporary construction workers will generate sanitarv waste, which if not
properly managed, can Also if there is no arrangement to handle the samtary waste, it could
pollute the surface/under-ground water. There is the added risk of mosquito breedmg, if water
around the construction site is allowed to stagnate.
3.1.2AirPollution
Dust generated during the process of cutting and filling earth and improper burming causes air
pollution. Fly ash is also generated during cement mixing
3.1.3 Noise Pollution
Noise pollution due to operation of different types of equlpment and machinery durmg
construction activities may disturb the surroundmg premises, including residential dwellmgs,
schools, hospitals etc
3.1.4 Construction design issues
Some of the environmental nsks associated with poor design of laboratones are
e  lmpropcr design of fioonng may lead to falls, slippage, retention of infectious matenal ctc
* Absence of separate waste movement comdor may cause occupational health hazard
e Inadequate and poor qualitv of dnnking water could be a health hazard
* Insufficient ventilation and absence of natural lighting may adversely affect health and
energy efficiency
•  Improper design of fire safety system could result in leakage of hazardous matenals
3.2 Environmental Impacts related to Laboratory Operation
Somne of the enviromneintal unpacts associated with regular laboratory operations are hsted
below.
3.2.1 Water Pollution
The food and drLg laboratories use a xvide range of chemicals, dismfectants and sample drLgs
Direct release, without treatment and segregation of any of these chemicals and hazardous wastes
to the drain without treatment can contaminate and corrode the waste water svstem and create
health nsks for the general public, directly or mdirectly. Such pollution is also detnmental to
aquatic life and the manne environment
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3.2.1 Air Pollultion
The opeattion of laboratorics miay iesult m a Liuinber of haiz-adous cmi'ssiolls to tie au fiom frune
hioods and vents sterilization / disinfection technologies, plant operations (boilers and
generators). refrigeranits (Ozone depleting substances) and treatment technologies (mculerators. if
any) Open and incomplete burning of wastes can creatc hazardous air emissions such as dioxins
3.2.2 Soil Contaminiation
The disposal of untreatcd and un-scgregated solid wastc (containing organic, degradable mixed
with hazardous chemicals) can result in contamination of the soil and the solid waste system
3.2.3 Handling & Disposal of Clhemicals and hazardous wastes
Improper handling of hazardous chemicals is a hcalth hazard for Lhe iaborator- workers and its
indiscriminate disposal can have environmental nsks as detailed above The same applies for
other substances, such as untreated and expired drugs, treated samples of food and drugs and
sharps (needles. symrnges. broken laboratory glassware etc).
Rag-pickers. whose livelihood is dependent on the facilitv are also at nsk though infection and
uijury lndiscriminate dumping of wastes can also result In illegal and dangerous rccvcling of
chemicals, sharps and other substances, which can become a pubhc health hazard.
Poor drainage and infrequent collection resulting in decomposition of wastes around the facilitv
can encouragc breedmg of mosquitoes, flies, rats and other scavengers.
4.   Environmental Impact Management and Mitigation
Precautionary measurcs to ensure high environmental and health safety standards would bc
ensured while planning, designing, and constructing laboratones. Emphasis would be given to
pollution prevention and control rather than clean-up
4.1 Mitigation of environmental impacts during Laboratory Construction
4. 1.1 National code of practices:
The design and construction of the laboratories will comply with the existing set of codes.
regulatory guidelnes and manuals, as listed below-
•  National Building Code of India
o  IS 1172-1983. Code of basic requirements for Water Supply, drainage and Sanitation
•  IS 2065-19o3 Code of practice for water supply in buildungs
*  IS 1742-1983. Code of practice for building drainage
1 IS 1200 Code of practice for water supply and drains
*  Central Public Health and Environmental Engineenng Organization (CPI-IEEO) manual
on Water Supply & Water Treatment
*  CPHEEO manual on Sewerage & Waste Treatment
* CPHEEO manual on Solid Waste Management.
•  Tariff Advisor- Conmittcc ([AC) manual on Firc Protection Systcm
The construction practices shall also complv with the national standards and code of practices
established bx the Ministry of Environment and Forests and othcr environmental agencies. sonic
aspects of whlich are hlighlighted below
* Site cleanng before construction and work place. all trash. dcbns and other weeds will be
remi ovcd



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•  Site clearing before construction and work place, all trash, debns and other weeds will be
removed.
*  Metal or heavy-duty plastic refuse contamers with tight fittung lids for disposal of all
garbage or trash wltl be used Refuse containers shall be kept upright with their lids shut
tight. These containers shall be emptied daily to maintain site samtation
*  Temporary fencing around the project site wllt be provided to regulate the entry and exit
of material, personnel and equipment
*  All existing stream courses and drams within, and adjacent to the site will be kept safe
and free from any debns and any excavated materials arising from the works
*  It will be ensured that chemicals and concrete agitator washings are not deposited m the
watercourses.
All water and waste products arising on the site shall be collected and removed from the
site via a suitable and properly designed temporary drainage system and disposed off at a
location and in a manner that will cause neither pollution nor nuisance
*  Temporary drainage works will be constructed, mamtained, removed and reinstated for
the avoidance of damage by floodmg and silt washed down from the works
* In the event of any spoil or debris from construction works being deposited on adjacent
land or silt washed down to any area, all such spoil, debns or material and silt shall be
immediately removed and the affected land and areas restored to their natural state by the
contractor to the satisfaction of the employer's representative.
Additionally a team of experts in environmental planning and designig from the internal
Environment wing of the construction management consulting firm will review and approve the
design before construction.
4.1.2 Design improvements
Following environmental factors wlfl be taken care while designing laboratory facihties for safer
storage, handling, treatment and disposal of waste
*  Chemical/infection resistant floonng/plastenng
* Proper waste movement separate corridor planning/ exist,gate etc
* Natural lighting and well ventilated system
* Adequate and good quality water supply system.
* Sanitary and drainage system for waste water flow
* Storage bins and collection equipment for different categories of waste
*  On-site/off-site waste treatment facilities
* Secured landfill site
•  Ducts, fume hoods for proper air circulation/ exhaust of toxic and other gases
* Fire safety
4.2 Mitigation of environmental impacts during Laboratory operations
Many of the pollution problems associated with laboratory wastes stem from the types of
matenals and chemicals used. Establishing good purchasing and procurement practices is the first
step in effective pollution control Ensunng the selection and implementation of environmentally
sound and cost-effective treatment technologies is an important element m the process. The
option for final disposal of infectious and hazardous will be decided in consultation with the State
Pollution Board Identification of landfills (on-site or off-site) and evaluation of the condition of
those landfills to accept wastes from these treatment technologies should be done. For off-site
facilities, contractual arrangements with specialized independent transportation companies can be
considered. If such facilities exist within a feasible neighbourhood, construction of leachate
proof deep bunal pit will need to be considered for disposal of hazardous waste.
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Plannig of a waste management system will take into consideration pollution prevention, waste
minimization and recyclng activities. (This will usually entail several different systems to
manage the multiple waste streams identified for treatment. The planned waste management
system has been shown in flow chart, attached as Annex I
4.2.1 Identification of materiatlwaste
All type of solid, liquid and gaseous waste generated from different sources will be identified and
segregated for storage, collection, treatment, transportation and eventual disposal.
4.2.2 Storage
All chemicals will be stored in proper identified place as per manufacturer's instructions and if
required, separate from other chemicals or environmental conditions which can cause reactions
Closed containers will be used for storage of hazardous chemicals Separate storage areas will be
identified for mcompatible chemicals
4.2.3 Segregation & collection
Most of the waste is a combination of hazardous and non-hazardous wastes. By establishing
g,,ood segregation practices at source, effective waste management (including treatment and
disposal) can be implemented with less effort and minumal resources The different categories of
waste wllU be quantified and analysed fbr handling and disposal
The waste will be segregated at source and collected in proper identified color coded storage bms/
containers. Labeling and codLng of hazardous waste will be done, so that emergency services will
be able to deal with accidental spillages The waste will be collected in wheel barrows from the
storage bm/contamers and transported to identified storage areas inside or outside the facility
Personnel safety measure will be ensured while segregating and collecting different categones of
waste
4.2.4 Transportation
The hazardous solid and liquid waste collected in containers will be taken to off-site treatment
/disposal facilities in specially designed vehicles. Contractual arrangements can be made with
specialized pnvate agencies in the area of waste management. If no such facilities exist within a
feasible neighbourhood, construction of leachate proof deep burial pit will need to be considered
for disposal of hazardous waste
4.2.5 Treatment and Disposal
There is no standard treatment process that adequately treats all the hazards identified in health
care wastes.
X Liquid waste
To safeguard against water pollution, precautionary measures will be taken at source to reduce
the quantity and strength of pollutants in the waste water flow Waste water will be segregated at
source, using the separate drainage system for laboratory waste. Liquid waste generated from
different sources will be treated and disposed as detailed below
(a) Domestic waste The waste generated from toilet, kitchen, plain hand washmg are non-
infectious and can be disposed in the public sewage system, which is finally connected to
terminal STP. In absence of public sewer, this waste can be disposed in a septic tank or
biological filter.
(b) Chemical Waste The infectious liquid waste will be disinfected by treatment with different
Environment Plan, 25 Oct, 02



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disinfectant reagents such as hypochlonde solution, savlon etc. The waste generated from
food and drug sample analyses, solvents, disinfectmg reagents, glassware and apparatus
cleanmg solutions and other accessones in the laboratories will be given chemical
pretreatment viz. neutralization before final disposal m sewage system If there is presence of
heavy metals or other hazardous contamination, the waste will be given onsite treatment, if
available, before disposal If on-site treatment is not feasible, the waste will be stored in
contamer and taken to nearby treatment facilities
Solid waste
(a) Municipal Solid waste  The non-hazardous solid waste generated from the kitchen, toilet,
packaging, facility cleanng and sweeping etc, will be disposed at nearby municipal landfill
sites, m accordance with Municipal Solid Waste disposal guidelines.
(b) Hazardous Waste. Thils category of waste is cntical and needs careful handling and disposal.
Disposal methods for the various types of hazardous wastes are detailed below
•  Sharps : Needles, syringes and other sharp instruments will be placed in puncture-
resistant plastic/metal containers. They can be boiled/autoclaved or chemically
disinfected, mutilated in shredder and then buried m secure land fill site Glassware and
other solid matenal can be disinfected by autoclaving, sterlisation or by other metfiods.
* Samples: Drug samples for analysis will be disposed of in secured landfills For food
samples which are bio-degradable the option of composting wlll be explored.
*  Pharmaceutical Waste: Expired or unwanted drugs or other chemicals will be retumed to
distributing companies for proper disposal or buried in secured landfill site
*  Pressurized Containers: Containers can be depressunsed by cutting holes or disposed in
secured landfill site or they can recycled after chemical disinfections.
• Battenes. Will be disposed in secured landfill
* Generator Oil. Will be soaked m cotton and disposed in secured landfill
If on-site deep burial is not possible, the waste can be stored in different contamer/ bags and
transported to appropnate off-site facilities Contracting local private entrepreneurs in the field of
waste management can be an option to save capital as well as operation & maintenance cost of
waste treatment equipments
5. Environmental Management Action Plan
5.1. Scope and Outcome:
To strengthen the system for management of environmental health and safety In the food and
drug testmg laboratories, the Environmental management action plan will detail (a) procedures
for handling equipment and materials; (b) use of personal protective equipment including
adoption of safe work practices; and (c) management of bio-medical wastes
The action plan will specifically address:
*  How to ensure a safe laboratory environment to protect the health of the staff working at
the food and drug testing laboratories
*  How to ensure safe disposal of infectious and chemically toxic wastes produced from
food and drug testing laboratones
*  Who will be accountable to implement the plan for promoting environmental safety and
disposal of toxic material as per the National guidelines
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How to integrate these concerns m a sustained manner with the proposed National
Program of building capacities of the food and drug admuuistration
One outcome of the action plan is the development of a set of standards and an operating manual
for Food and Drug Laboratones These elements widl be tncorporated into the existing national
GLP manual to expand its scope to cover environmental management practices
The Plan will be implemented in 50% of the project laboratones by mid term and will be
extended in a phased manner m other laboratones
5. 2. Process:
The preparation of the action plan will be done sequentially m the following six phases
i)     Assessment
ii)    National Workshop
uii)   Trammg plans and material
iv)    Implementation of Trainig and Procurement
v)    Implementation and documentation
vi)    Monitoring of implementation
MOHFW would appoint an agency or consultant to facilitate development of the proposed action
plan. The Project Management Unit headed by the Joint Secretary, MOHFW would provide
overall coordination, administrative assistance and managenal oversight
5. 3. Action Plan
5.3.1 Assessment
An assessment will be undertaken to review the health and safety and environmental practices in
a representative sample of food and drug testing laboratones To ensure adequate representation,
the laboratones would be stratified by size (medium, small and very small based on number of
staff and samples handled) and a survey sample will be taken from each group. It is proposed to
cover at least 10% of laboratories from each group for the assessment Pnor to the assessments, a
detailed checklist will be prepared and pre-tested to guide the survey team in accurate and
consistent data collection
Output:
i)    A "background" document will be prepared, which will set the stage for the national
workshop The document will include the survey findings on the followmg issues
* Prevailing health, safety and environmnental practices,
*  Types and quantities of hazardous matenals used and waste generated,
*  Management practices with regard to labelng, handlmg, storage and disposal of wastes;
* Commitment of management towards worker safety and environment,
Existmg health surveillance protocols for the persons at risk from exposures to chemicals,
* Preparedness to deal with emergencies; and
* Training needs for good waste management of drug and toxic wastes
5.3.2 National Workshop:
A national workshop will be organized to discuss the findmgs of the assessment. To facilitate
focused discussion, the participation at the workshop will be limited to a select group, identified
on the basis of established criteria (qualification, experience, type of laboratory) In addition to
representatives from MOHFW and state authorities, the group could include experts from
Environment Plan, 25 Oct, 02



12
universities, representatives from WHO, NGOs and industry. Based on the findings of the
assessment and the discussions, draft guidelmes of environmental health and safety practices for
the laboratones will be formulated
Outputs
i)    An environmental management health and safety component will be added to the existing
national GLP. This component will establish a general set of Codes of practices for all
laboratones, with specific provisions to address the environmental impacts and worker
safety issues
ii)   Detailed specific operatng manuals for individual laboratories wlll be formulated,
including a set of environmental standards to guide construction/upgrading of food and
drug testing laboratones
iii)  An Environmental Health and Safety Plan (EHS) will be developed, which will mclude
guidelmes for worker safety in use of chemicals, general safety, proper disposal of waste,
medical surveillance and emergency preparedncss It will also dehneate the
responsibilities of the laboratory staff, recommend actions to deal with the identified
problems, establish a reporting system and safety committees.
5.3.3. Training plans:
Based on the assessment and the guidelmes, training modules will be developed along with
checklists for monitonng separately for food and drug laboratories A detailed tramning schedule
will be prepared m consultation with MOHFW and state authorities.
Employee training programs will include, at a minimum, the following subjects
* Methods of detecttng the presence of hazardous chemicals (sight, odor, real-time monitoring,
air sampling, etc)
* Basic toxicological principles, including toxicity, hazard, exposure, routes of entry, acute and
chronic effects, dose-response relationship, LD50, threshold limit values and permissible
exposure limits, exposure time, and health hazards related to classes of chemicals,
* Good laboratory practice, including general techniques designed to reduce personal exposure
and to control physical hazards, as well as specific protective mechanisms and warmng
systems used in mdividual laboratories Appropriate use of fume hoods is to be specifically
addressed;
*Description of mformation available, including Matenal Safety Data Sheets,
e Emergency response actions appropnate to individuals laboratones; I
*  Applicable details of the Plan, mcluding general and laboratory-specific Standard Operation
IProcedures,
Outputs:
i)    Training modules and checklists for improving environmental safety m food and drug
laboratones
n)    Training plans
5.3.4. Implementation of Training and Procurement of equipment
Each laboratory will identify two officers as trainers in environmental safety The MOHFW with
help of the consultant will organize training of tramers who in turn would organize training of all
staff at their respective laboratones. The trainig will include good laboratory practices, including
substance handling, pollution prevention, waste segregation, disposal processes and emergency
management. Specific indicators will be used to measure the progress and quality of the
decentralized trainig. It is proposed that few national resource persons will be identified to
Environment Plan, 25 Oct, 02



13
undertake independent assessment of decentralized trainig and provide feedback to safety
committee. implementation of environmental action plan would be included in the scope of the
quality audit of laboratones thus would provide periodic feedback based on which refresher
training would be provided
Outputs:
i)    Two Tramers trained in each laboratory
u)    Decentralized Training Programs organized
iii)  Resource persons identified to monitor and improve quality of decentralized trainmng
5.3.5. Implementation:
The MOHFW will be the lead agency coordinating the implementation, supported by the PMU
Two senior officers from MOHFW, one from the DGCI and one from PFA, will be responsible
to oversee the implementation of the plan and facilitating the adaptation of good practices at the
laboratories (if required, organizing reonentation training). Each laboratory will have an officer
designated as Environmental Health and Safety Officer (EHSO) who will be accountable for
implementation of the plan Dunng this phase, a detailed inventory of hazardous matenals and
material safety data sheets would be prepared.
Outputs:
i)    Environmental action plan implemented
ii)   Inventory of hazardous matenals prepared
iii)  Material Safety Data Sheets prepared
5.3.6. Monitoring of Implementation
Every laboratory must have an environmental health and safety officer (EHSO) to organize
different activities and monitor the implementation of the environmental plan. Routine
monitoring would be done by EHSO at laboratory level He/she will be responsible for
maintaining records as per the agreed protocols. In addition, two health, safety and environmental
surveys would be undertaken (once dunng mid term another before project closure) by a
competent independent agency Environmental audit will be taken up along with technical audit
of the food and drug laboratones.
Outputs
i)    Compliance reports/records
ii)   Inventory of hazardous material and Material safety data sheets
iii)  Audit reports
Environment Plan, 25 Oct, 02



14
7   Summary Matrix of the Environment Plan
The    environment   component    seeks    to    upgrade   laboratones  in
terms of their operational procedures for the storage and handling of chemicals as well as the
storage and disposal of the waste generated. The Project would provide for the preparation of a
Laboratory Guidance Manual that will contain standard operating procedures (SOPs) and specific
implementation plans for selected laboratones  During project implementation, laboratory
staff would be trained on the use of the Laboratory Guidance Manual m selected laboratories
Laboratones would report on their efforts on waste management and an audit would be conducted
to assess the environmental impacts
7.1 Budget For Addressing Environmental Issues
ACTIVITY                                       By When?         Budget By Whom
Assessment to review the health and safety and  Year 1          Rs. 15   Project
environmental practices in sample of food and drug  VS! Six Months  Lakhs  Management
testing laboratones                                                     Unit (PMU)
National workshop to discuss the findings of the
assessment and review proposed actions                                  PMU
(Rs. 10 lakhs)                                 Year 2
Development of an EHS Plan, and operating manuals 2nd Six Months
for individual laboratones, including environrmental            Rs. 15
standards to guide construction/upgradmg of food and           lakhs
drug testing laboratories
(Rs. 3 lakhs)
Preparation of tramning module, schedule, manual and  Year 2
checkhsts (for those involved in implementing the  s't Three Months
plans and program) (Rs 2 lakhs)
Traming of trainers and laboratory staff (COST)  Year 2
2nd Three Months
Implementation of the plan.                    YEAR 3 - 5       Rs 50   Environmental
Lakhs   Consultant in the
PMU
External Audit                                 Mid-term review  Rs 25   MOtlFW
Lakhs   (Environmental
On going   Rs.5 0 lakhs                                                 Auditor)
External   Rs. 20.0 lakhs
Environment Plan, 25 Oct, 02



Annex I
VNASTE
LIQUI WASTE                                                                 SOLIDWASTE                                            GASiOL  SWASTE
NON
DOMESTIC               DOMESTIC
| + 1                                                                                                           1,|r.iTRAP(ING
DISCHARGE TO                                 CHMICAL
eatment             PUBLIC SEWER   I F                           WASTE
SCRUBBERS OR
CYCLONE                        DISCHARGE
PRECIPITATORS                  THROUGH
(Non-contaminated)                                 AUTOCLAVING                                            ETC                            CHIMNEY AT
GLASS OR DRY               BIODEGRADABLE                                 PROPER
Isposal                                                 l                                        WASTE                      WASTE                                         HEIGHT
,;,                                    TO  LAND  FILL
SOLVENTS, SITE                4                          4.
SEPARATE             CHEMICALS,
COLLECTION           PESTICIDES              TO BE RECYCLED             COMPOSTING
DISINFECTION                                         DEEP
AT SOURCE                                            BURRIAL
IF                 ~~~~~~~~or
Collection
NESISSARY              DISCHARGE
TREATMENT IF           IN TO PUBLIC
STANDARDS              SEWER   IF
EXCEEDS                STANDARDS
PERMISSIBLE            WITH    IN
LIMITS                 LIMiTS
Collection, Treatment 8 Disposal
By Private Enterpreneure