METODE ESA: ENVIRONMENTAL SAFETY ASSESSMENT DALAM KAJIAN LINGKUNGAN MODEL KONSEPTUAL

1. METODE ESA:ENVIRONMENTAL SAFETY ASSESSMENTDALAM KAJIAN LINGKUNGANMODEL KONSEPTUAL SRUT+SMNO.PDKL.PPSUB.2013

2. ENVIRONMENTAL SAFETY ASSESSMENT Eric Silberhorn, PhD, DABT Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

3. What are the risks of direct or indirect adverse outcomes associated with the consumption of the GE animal as food or feed? Direct or indirect effects from introduction of the GE animal into the environment? What are the direct and indirect risks posed to the GE animal? (e.g., can surveying the health and other phenotypic characteristics of the animal inform us with respect to risk to the animal and potential human food safety concerns?) Are the genotype or phenotype changing over the product lifespan in a way that would affect the risks associated with the product? Is there a plan in place to monitor those changes? Does the insertion of the rDNA construct pose a hazard to the animal, humans, other animals by feed, or the environment? Are there sequences that are likely to contain potential hazards to the animal, humans, or animals consuming food from that animal, or the environment? e.g., does the construct contain mobilizable sequences from viruses that may be endemic in that species? Describes the animal, construct, and proposed claim Environmental Safety What hazards/risks have been identified in the hierarchical review? Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

4. Statutory/Regulatory Requirements • Sponsor must submit Environmental Assessment/supporting data under INAD/NADA • National Environmental Policy Act (NEPA) requirement triggered by “agency action” • EA  FONSI? (finding of no significant impact) • If no FONSI, EIS (environmental impact statement) Environmental Assessment: General Risk Questions For a specific GE animal (population) containing a specific rDNA construct…. • Risk(s) under conditions of use/free release? • Likelihood of escape/free release? • Containment/redundancy • Potential adverse outcomes associated with escape/free release? Considered in context of appropriate comparator on a case-by-case basis. Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

5. Conceptual Model for Risk Assessment Source(s) Escape or Introduction Accessible Environments Biological Containment Physical Containment Able to Survive Able to Reproduce Dispersion Establishment Net Fitness Direct and Indirect Effects Wild Conspecifics Spread of Transgene(s) Impact on Target Resources in Accessible Environments (habitats, wildlife) Feral Relatives Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

6. Conceptual Model for Risk Assessment This previous slide is a flow diagram describing the steps that a risk assessor might follow in order to understand the risks associated with an environmental release of GE animal. The flow diagram begins with understanding the Source (the physical location in which the GE animal is being housed (e.g., farm, hatchery)). This includes a complete description of the physical containment that has been imposed on that source. The next step considers either intended release or the likelihood of an escape from containment. In the next step, the risk assessor evaluates the environments accessible to the released or escaped GE animal. The ability to survive comprises the next steps, followed by an assessment of either dispersion or the ability for that animal to reproduce considering any applicable biological confinement. If the animal is capable of reproducing, the next point of evaluation looks at the spread of the transgene(s) via horizontal transfer to wild conspecifics or to feral relatives. Another path from the ability to reproduce involves an evaluation of the ability of the GE animal to become established in the local environment. Finally, the assessment ends with a consideration of the potential direct and indirect effects that the released or escaped GE animal can cause to target resources in the accessible environments (e.g., habitats and on wildlife). Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

7. Prioritization of Concerns Consideration of the following factors: • Ability of GE animal to disperse into diverse communities upon release or escape • “Fitness” of GE animal within the receiving ecosystem • Stability and resiliency of the receiving community Overall concern is a product (and not the sum) of these three variables Consequences of Introduction, Escape, and Dispersion Depends on • Physical locations of use or release • Extent of containment (if applicable) • Physical • Biological (sterility, triploidy, monosex) • Geographical • Niche limitations • Domestication of species (ability to become feral) • Mobility of species Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

8. Genetic contribution by an individual’s descendants to future generations of a population Fitness depends on both survival and reproduction Net fitness components include Juvenile and adult viability Age at sexual maturity Female fecundity/male fertility/mating success * These characteristics are used to assess fitness regardless of an animal’s GE status Fitness* Does incorporation of the rDNA construct alter the animal’s fitness? Potential examples of altered fitness • Disease resistance • Temperature tolerance • Growth factors / hormones • Nutrient/carbohydrate utilization Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

9. Direct and Indirect Effects • Pathogen / disease transfer • Genetic disturbance • Resource competition • Displacement • Habitat destruction • Predation Population changes Community/Ecosystem disruptions Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013 Sanitasiadalahusahapengendalianfaktor-faktorlingkunganfisikmanusiayangmungkinmenimbulkanataudapatmenimbulkanhal-hal yang merugikanbagiperkembanganfisik, kesehatandandayatahanhidupmanusia. Ruanglingkup : Cara pembuanganekskreta, air buangandansampah Penyediaan air bersih Perumahan Makanan Individudanmasyarakat agar berperilakusehat (personal hygiene) Arthropoda, mollusca, binatangpengeratsertapejamulainnya Kondisiudara Pabrik, perkantoran, permukiman, jalanumumdanlingkunganumumnya.(WHO) DIUNDUH DARI: http://www.scribd.com/doc/19374542/Definisi-Kesehatan-Lingkungan ……. 13/1/2013

10. Potential Environmental Risks Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

11. Environmental Assessment General Risk Questions • Risk associated with the goats in confinement? • Likelihood of escape? • Potential adverse outcomes associated with escape? Conclusions • No environmental risks from confined rhAT goats, wastes • Escape unlikely (multiple levels of confinement, security, ID) • In event of escape without recapture, survival, reproduction, population establishment is highly unlikely Note: EA/FONSI posted http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM118087.pdf http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM163814.pdf Sumber: diunduhdari: www.fda.gov/downloads/AnimalVeterinary/.../UCM179343.ppt,... 4/1/2013

12. ENVIRONMENTAL HAZARD ASSESSMENT Environmental hazard' is the state of events which has the potential to threaten the surrounding natural environment and adversely affect people's health. This term incorporates topics like pollution and natural disasters such as storms and earthquakes. Hazards can be categorized in five types: Chemical Physical Mechanical Biological Psychosocial Diunduhdari: http://en.wikipedia.org/wiki/List_of_environmental_health_hazards ………. 9/1/2013 UU No. 36 Tahun 2009 TentangKesehatan BAB XI. KESEHATAN LINGKUNGAN Pasal 162 Upayakesehatanlingkunganditujukanuntukmewujudkankualitaslingkunganyangsehat, baikfisik, kimia, biologi, maupunsosial yang memungkinkansetiaporangmencapaiderajatkesehatan yang setinggi-tingginya.

13. ENVIRONMENTAL HAZARD Environmental Hazards are hazards that everyone is exposed to in their everyday lives. These hazards are part of nature but can be very harmful if the proper precautions aren't taken. Often we do not have a choice regarding whether or not we may be exposed to environmental hazards.  However, we are usually able to make lifestyle and occupational choices that may increase our risk of exposure to things that may adversely affect our health, such as hazardous chemicals and metals, radiation, pathogenic microorganisms and other things in the environment that are bad for our health. Diunduhdari: http://peer.tamu.edu/curriculum_modules/properties/module_4/index.htm………. 9/1/2013

14. ENVIRONMENTAL HAZARD CONTOH-CONTOH Allergens; Anthrax Antibiotic agents in animals destined for human consumption Arbovirus Arsenic - a contaminant of fresh water sources (water wells) Asbestos – carcinogenic; Avian influenza Bovine spongiform encephalopathy (BSE) Carcinogens Cholera Cosmic rays DDT Dioxins Drought Dysentery Electromagnetic fields Endocrine disruptors Epidemics E-waste Explosive material Floods Food poisoning Fungicides Furans Haloalkanes Heavy metals Herbicides Hormones in animals destined for human consumption Lead in paint Light pollution Lighting Lightning Malaria Marine debris Mercury Molds Mutagens Noise pollution Onchocerciasis (river blindness) Pandemics Pathogens Pesticides Pollen for allergic people Polychlorinated biphenyls Quicksand Rabies Radon and natural radioactivity Severe acute respiratory syndrome (SARS) Sick building syndrome Soil pollution Tobacco smoking Toxic waste Ultraviolet light Vibration Wildfire X-rays Diunduhdari: http://en.wikipedia.org/wiki/List_of_environmental_health_hazards ………. 9/1/2013

15. NATURAL DISASTERS A natural disaster is a major adverse event resulting from natural processes of the Earth; examples include floods, severe weather, volcanic eruptions, earthquakes, and other geologic processes. A natural disaster can cause loss of life or property damage, and typically leaves some economic damage in its wake, the severity of which depends on the affected population's resilience, or ability to recover. GEMPA BUMI An earthquake is the result of a sudden release of energy in the Earth's crust that creates seismic waves. At the Earth's surface, earthquakes manifest themselves by vibration, shaking and sometimes displacement of the ground. The vibrations may vary in magnitude. Earthquakes are caused mostly by slippage within geological faults, but also by other events such as volcanic activity, landslides, mine blasts, and nuclear tests. The underground point of origin of the earthquake is called the focus. The point directly above the focus on the surface is called the epicenter. Earthquakes by themselves rarely kill people or wildlife. It is usually the secondary events that they trigger, such as building collapse, fires, tsunamis (seismic sea waves) and volcanoes, that are actually the human disaster. Many of these could possibly be avoided by better construction, safety systems, early warning and evacuation planning. Diunduhdari: http://en.wikipedia.org/wiki/Natural_disasters………. 9/1/2013

16. NATURAL DISASTERS ERUPSI VULKANIK Volcanoes can cause widespread destruction and consequent disaster in several ways. The effects include the volcanic eruption itself that may cause harm following the explosion of the volcano or the fall of rock. Second, lava may be produced during the eruption of a volcano. As it leaves the volcano, the lava destroys many buildings and plants it encounters. Third, volcanic ash generally meaning the cooled ash - may form a cloud, and settle thickly in nearby locations. When mixed with water this forms a concrete-like material. In sufficient quantity ash may cause roofs to collapse under its weight but even small quantities will harm humans if inhaled. Since the ash has the consistency of ground glass it causes abrasion damage to moving parts such as engines. The main killer of humans in the immediate surroundings of a volcanic eruption is the pyroclastic flows, which consist of a cloud of hot volcanic ash which builds up in the air above the volcano and rushes down the slopes when the eruption no longer supports the lifting of the gases. It is believed that Pompeii was destroyed by a pyroclastic flow. A lahar is a volcanic mudflow or landslide. Diunduhdari: http://en.wikipedia.org/wiki/Natural_disasters………. 9/1/2013

17. NATURAL DISASTERS BANJIR A flood is an overflow of an expanse of water that submerges land. The EU Floods directive defines a flood as a temporary covering by water of land not normally covered by water. \ In the sense of "flowing water", the word may also be applied to the inflow of the tide. Flooding may result from the volume of water within a body of water, such as a river or lake, which overflows or breaks levees, with the result that some of the water escapes its usual boundaries. While the size of a lake or other body of water will vary with seasonal changes in precipitation and snow melt, it is not a significant flood unless the water covers land used by man like a village, city or other inhabited area, roads, expanses of farmland, etc. Diunduhdari: http://en.wikipedia.org/wiki/Natural_disasters………. 9/1/2013

18. NATURAL DISASTERS KEKERINGAN Drought is unusual dryness of soil, resulting in crop failure and shortage of water for other uses, caused by significantly lower rainfall than average over a prolonged period. Hot dry winds, high temperatures and consequent evaporation of moisture from the ground can contribute to conditions of drought. A drought is an extended period of months or years when a region notes a deficiency in its water supply whether surface or underground water. Generally, this occurs when a region receives consistently below average precipitation. It can have a substantial impact on the ecosystem and agriculture of the affected region. Although droughts can persist for several years, even a short, intense drought can cause significant damage and harm the local economy. Succulent plants are well-adapted to survive long periods of drought. Many plant species, such as cacti, have adaptations such as reduced leaf area and waxy cuticles to enhance their ability to tolerate drought. Some others survive dry periods as buried seeds. Semi-permanent drought produces arid biomes such as deserts and grasslands. Most arid ecosystems have inherently low productivity. This global phenomenon has a widespread impact on agriculture. Lengthy periods of drought have long been a key trigger for mass migration and played a key role in a number of ongoing migrations and other humanitarian crises in the Horn of Africa and the Sahel. Diunduhdari: http://en.wikipedia.org/wiki/Drought ………. 9/1/2013

19. NATURAL DISASTERS TORNADO A tornado is a violent, dangerous, rotating column of air that is in contact with both the surface of the earth and a cumulonimbus cloud or, in rare cases, the base of a cumulus cloud. It is also referred to as a twister or a cyclone, although the word cyclone is used in meteorology in a wider sense, to refer to any closed low pressure circulation. Tornadoes come in many shapes and sizes, but are typically in the form of a visible condensation funnel, whose narrow end touches the earth and is often encircled by a cloud of debris and dust. Most tornadoes have wind speeds less than 110 miles per hour (177 km/h), are approximately 250 feet (80 m) across, and travel a few miles (several kilometers) before dissipating. The most extreme tornadoes can attain wind speeds of more than 300 mph (480 km/h), stretch more than two miles (3 km) across, and stay on the ground for dozens of miles (perhaps more than 100 km). Diunduhdari: http://en.wikipedia.org/wiki/Natural_disasters………. 9/1/2013

20. ENVIRONMENTAL DISASTERS An environmental disaster is a disaster to the natural environment due to human activity,which distinguishes it from the concept of a natural disaster. In this case, the impact of humans' alteration of the ecosystem has led to widespread and/or long-lasting consequences.It can include the deaths of animals (including humans) and plants, or severe disruption of human life, possibly requiring migration Environmental disasters can have an effect on agriculture, biodiversity, the economy and human health. The causes include pollution, depletion of natural resources, industrial activity or agriculture. Diunduhdari: http://en.wikipedia.org/wiki/List_of_environmental_disasters………. 9/1/2013 UU No. 36 Tahun 2009 TentangKesehatan Pasal 163 Lingkungansehatsebagaimanadimaksudpadaayat (2) bebasdariunsur-unsur yang menimbulkangangguankesehatan, antara lain: Limbahcair; Limbahpadat; Limbah gas; Sampah yang tidakdiprosessesuaidenganpersyaratan yang ditetapkanpemerintah; Binatangpembawapenyakit; Zatkimia yang berbahaya; Kebisingan yang melebihiambangbatas; Radiasisinarpengiondan non pengion; Air yang tercemar;  Udara yang tercemar; dan Makanan yang terkontaminasi.

21. ENVIRONMENTAL DISASTERS Agricultural Main article: Environmental impact of agriculture Salinity in Australia Salinization of the Fertile Crescent The Dust Bowl in Canada and the United States (1934–1939) The Great sparrow campaign; sparrows were eliminated from Chinese farms, which caused locusts to swarm the farms and contributed to a famine which killed 38 million people. Africanized bees, known colloquially as "killer bees" Mismanagement of the Aral Sea "Dirty dairying" in New Zealand. Human health Introduction of the Bubonic Plague (the Plague of Justinian) in Europe from Africa in the 7th century resulting in the death of up to 60% (100 million) of the population. Introduction of the Bubonic Plague (the Black Death) in Europe from Central Asia in the 14th century resulting in the death of up to 60% (200 million) of the population and recurring until the 18th century. Introduction of infectious diseases by Europeans causing the death of indigenous people during European colonization of the Americas Health effects arising from the September 11 attacks Goiânia accident, human deaths resulting from dismantling a scrapped medical machine containing a source of radioactivity Diunduhdari: http://en.wikipedia.org/wiki/List_of_environmental_disasters………. 9/1/2013

22. ENVIRONMENTAL DISASTERS Biodiversity Chestnut blight Extinction of American megafauna Extinction of Australian megafauna Deforestation of Easter Island Destruction of the old growth forests Rabbits in Australia Red imported fire ants Dutch Elm Disease Devil facial tumour disease Reduction in the number of the American Bison Introduction of the Nile perch into Lake Victoria in Africa, decimating indigenous fish species The Saemangeum Seawall Emerald Ash Borer Environmental threats to the Great Barrier Reef 2006 Zakouma elephant slaughter Invasive species in New Zealand The loss of Biodiversity of New Zealand Ghost nets Grounding of SS Makambo on Lord Howe Island Shark finning Decline of vultures in India due to Diclofenac leading to increased incidence of rabies Extinction of the Tasmanian Tiger Diunduhdari: http://en.wikipedia.org/wiki/Natural_disasters………. 9/1/2013

23. ENVIRONMENTAL DISASTERS INDUSTRIAL Minamata disease - mercury poisoning in Japan (1950s & 1960s) Ontario Minamata disease in Canada Itai-itai disease, due to cadmium poisoning in Japan Love Canal toxic waste site Seveso disaster (1976), chemical plant explosion, caused highest known exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) in residential populations Bhopal disaster (December 3, 1984, India), The leak of methyl isocyanate that took place in 1984 resulted in more than 22,000 deaths (and counting) and the various genetic diseases that will continue to be seen for generations to come among the newly born, caused by the negligence and corruption, ignoring safety standards in India by Warren Anderson, CEO of Union Carbide, a US company now a subsidiary of Dow Chemicals. Sandoz chemical spill into the Rhine river (1986) United States Environmental Protection Agency Superfund sites in the United States AZF Explosion at a Toulouse chemical factory (2001) 2005 Jilin chemical plant explosions The Sydney Tar Ponds and Coke Ovens sites in the city of Sydney, Nova Scotia, Canada, known as the largest toxic waste site in North America. Release of lead dust into Esperance Harbour. Release of cyanide, heavy metals and acid into the Alamosa River, Colorado from the Summitville mine, causing the death of all marine life within a 17 mile radius. Diunduhdari: http://en.wikipedia.org/wiki/Natural_disasters………. 9/1/2013

24. ENVIRONMENTAL DISASTERS Nuclear Chernobyl disaster in 1986 in Chernobyl, Ukraine, "killed at least 4056 people and damaged almost $7 billion of property". Radioactive fallout from the accident concentrated near Belarus, Ukraine and Russia and at least 350,000 people were forcibly resettled away from these areas. After the accident, "traces of radioactive deposits unique to Chernobyl were found in nearly every country in the northern hemisphere". Fukushima Daiichi nuclear disaster: Following an earthquake, tsunami, and failure of cooling systems at Fukushima I Nuclear Power Plant and issues concerning other nuclear facilities in Japan on March 11, 2011, a nuclear emergency was declared. This was the first time a nuclear emergency had been declared in Japan, and 140,000 residents within 20 km of the plant were evacuated. Explosions and a fire have resulted in dangerous levels of radiation, sparking a stock market collapse and panic-buying in supermarkets. Diunduhdari: http://en.wikipedia.org/wiki/Natural_disasters………. 9/1/2013

25. ENVIRONMENTAL HEALTH Environmental health is a branch of public health concerned with all aspects of the natural and built environment that may affect human health. Other phrases that concern or refer to the discipline of environmental health include environmental public health and environmental health and protection. The field of environmental health differs from environmental science in that environmental health is concerned with environmental factors affecting human health whereas environmental science is concerned with the environment as it affects ecosystems. Environmental health addresses all the physical, chemical, and biological factors external to a person, and all the related factors impacting behaviours. It encompasses the assessment and control of those environmental factors that can potentially affect health. It is targeted towards preventing disease and creating health-supportive environments. This definition excludes behaviour not related to environment, as well as behaviour related to the social and cultural environment, and genetics. Diunduhdari: http://en.wikipedia.org/wiki/Environmental_health ………. 9/1/2013

26. ENVIRONMENTAL HEALTH Environmental health is defined by the World Health Organization as: Those aspects of the human health and disease that are determined by factors in the environment. It also refers to the theory and practice of assessing and controlling factors in the environment that can potentially affect health. Environmental health as used by the WHO Regional Office for Europe, includes both the direct pathological effects of chemicals, radiation and some biological agents, and the effects (often indirect) on health and well being of the broad physical, psychological, social and cultural environment, which includes housing, urban development, land use and transport. Environmental health services are defined by the World Health Organization as: Those services which implement environmental health policies through monitoring and control activities. They also carry out that role by promoting the improvement of environmental parameters and by encouraging the use of environmentally friendly and healthy technologies and behaviors. They also have a leading role in developing and suggesting new policy areas. Diunduhdari: http://en.wikipedia.org/wiki/Environmental_health ………. 9/1/2013

27. ENVIRONMENTAL HEALTH Environmental health addresses all human-health-related aspects of both the natural environment and the built environment. Environmental health concerns include: Air quality, including both ambient outdoor air and indoor air quality, which also comprises concerns about environmental tobacco smoke. Body art safety, including tattooing, body piercing and permanent cosmetics. Climate change and its effects on health. Disaster preparedness and response. Food safety, including in agriculture, transportation, food processing, wholesale and retail distribution and sale. Hazardous materials management, including hazardous waste management, contaminated site remediation, the prevention of leaks from underground storage tanks and the prevention of hazardous materials releases to the environment and responses to emergency situations resulting from such releases. Housing, including substandard housing abatement and the inspection of jails and prisons. Childhood lead poisoning prevention. Land use planning, including smart growth. Liquid waste disposal, including city waste water treatment plants and on-site waste water disposal systems, such as septic tank systems and chemical toilets. Medical waste management and disposal. Noise pollution control. Occupational health and industrial hygiene. Radiological health, including exposure to ionizing radiation from X-rays or radioactive isotopes. Recreational water illness prevention, including from swimming pools, spas and ocean and freshwater bathing places. Safe drinking water. Solid waste management, including landfills, recycling facilities, composting and solid waste transfer stations. Toxic chemical exposure whether in consumer products, housing, workplaces, air, water or soil. Vector control, including the control of mosquitoes, rodents, flies, cockroaches and other animals that may transmit pathogens. Diunduhdari: http://en.wikipedia.org/wiki/Environmental_health ………. 9/1/2013

28. AIR QUALITY INDEXES An air quality index (AQI) is a number used by government agencies to communicate to the public how polluted the air is currently or how polluted it is forecast to become. As the AQI increases, an increasingly large percentage of the population is likely to experience increasingly severe adverse health effects. Different countries have their own air quality indices which are not all consistent. Different countries also use different names for their indices such as Air Quality Health Index, Air Pollution Index and Pollutant Standards Index. Air quality is defined as a measure of the condition of air relative to the requirements of one or more biotic species or to any human need or purpose. To compute the AQI requires an air pollutant concentration from a monitor or model. The function used to convert from air pollutant concentration to AQI varies by pollutant, and is different in different countries. Air quality index values are divided into ranges, and each range is assigned a descriptor and a color code. Standardized public health advisories are associated with each AQI range. The AQI can go up (meaning worse air quality) due to a lack of dilution of air pollutants. Stagnant air, often caused by an anticyclone, temperature inversion, or low wind speeds lets air pollution remain in a local area, leading to high concentrations of pollutants and hazy conditions . An agency might encourage members of the public to take public transportation or work from home when AQI levels are high. Diunduhdari: http://en.wikipedia.org/wiki/Air_quality_index………. 9/1/2013

29. AIR QUALITY INDEX Understanding the AQI The purpose of the AQI is to help you understand what local air quality means to your health. To make it easier to understand, the AQI is divided into six categories: Each category corresponds to a different level of health concern. The six levels of health concern and what they mean are: "Good" AQI is 0 - 50. Air quality is considered satisfactory, and air pollution poses little or no risk. "Moderate" AQI is 51 - 100. Air quality is acceptable; however, for some pollutants there may be a moderate health concern for a very small number of people. For example, people who are unusually sensitive to ozone may experience respiratory symptoms. "Unhealthy for Sensitive Groups" AQI is 101 - 150. Although general public is not likely to be affected at this AQI range, people with lung disease, older adults and children are at a greater risk from exposure to ozone, whereas persons with heart and lung disease, older adults and children are at greater risk from the presence of particles in the air. . "Unhealthy" AQI is 151 - 200. Everyone may begin to experience some adverse health effects, and members of the sensitive groups may experience more serious effects. . "Very Unhealthy" AQI is 201 - 300. This would trigger a health alert signifying that everyone may experience more serious health effects. "Hazardous" AQI greater than 300. This would trigger a health warnings of emergency conditions. The entire population is more likely to be affected. Diunduhdari: http://airnow.gov/index.cfm?action=aqibasics.aqi………. 9/1/2013

30. AIR QUALITY INDEXES AQI colors EPA has assigned a specific color to each AQI category to make it easier for people to understand quickly whether air pollution is reaching unhealthy levels in their communities. For example, the color orange means that conditions are "unhealthy for sensitive groups," while red means that conditions may be "unhealthy for everyone," and so on. Diunduhdari: http://airnow.gov/index.cfm?action=aqibasics.aqi………. 9/1/2013

31. EHS : ENVIRONMENTAL, HEALTH & SAFETY Environment, Health and Safety (EHS) – also Safety, Health and Environment (SHE) or HES or HSE – is often used as the name of a department in corporations and government agencies. The EHS guidelines were created by the International Finance Corporation in 1998. Companies that aspire to be better environmental stewards invest in strong environmental, health and safety management, otherwise known as EHS. From an environmental standpoint, it involves creating a systematic approach to managing waste, complying with environmental regulations, or reducing the company’s carbon footprint. Successful EHS programs also include measures to address ergonomics, air quality, and other aspects of workplace safety that could affect the health and well-being of employees. Sanitasiadalahusahapengendalianfaktor-faktorlingkunganfisikmanusiayangmungkinmenimbulkanataudapatmenimbulkanhal-hal yang merugikanbagiperkembanganfisik, kesehatandandayatahanhidupmanusia. Ruanglingkup : Cara pembuanganekskreta, air buangandansampah Penyediaan air bersih Perumahan Makanan Individudanmasyarakat agar berperilakusehat (personal hygiene) Arthropoda, mollusca, binatangpengeratsertapejamulainnya Kondisiudara Pabrik, perkantoran, permukiman, jalanumumdanlingkunganumumnya. (sumber: WHO) Diunduhdari: http://en.wikipedia.org/wiki/Environment,_Health_and_Safety ………. 9/1/2013

32. EHS : ENVIRONMENTAL, HEALTH & SAFETY The EHS Guidelines are technical reference documents with general and industry-specific examples of Good International Industry Practice (GIIP). 1. Environmental 1.1 Air Emissions and Ambient Air Quality 1.2 Energy Conservation 1.3 Wastewater and Ambient Water Quality 1.4 Water Conservation 1.5 Hazardous Materials Management 1.6 Waste Management 1.7 Noise 1.8 Contaminated Land and Remediation 2. Occupational Health and Safety 2.1 General Facility Design and Operation 2.2 Communication and Training 2.3 Physical Hazards 2.4 Chemical Hazards 2.5 Biological Hazards 2.6 Radiological Hazards 2.7 Personal Protective Equipment (PPE) 2.8 Special Hazard Environments 2.9 Monitoring 3. Community Health and Safety 3.1 Water Quality and Availability 3.2 Structural Safety of Project Infrastructure 3.3 Life and Fire Safety (L&FS) 3.4 Traffic Safety 3.5 Transport of Hazardous Materials 3.6 Disease Prevention 3.7 Emergency Preparedness and Response 4. Construction and Decommissioning 4.1 Environment 4.2 Occupational Health and Safety 4.3 Community Health and Safety Diunduhdari: http://en.wikipedia.org/wiki/Environment,_Health_and_Safety ………. 9/1/2013

33. AIR QUALITY & HUMAN HEALTH Air Quality and Human Health The Clean Air for Europe (CAFE) Programme was set up to review the scientific basis of air quality regulation for the EU thematic strategy. CAFE commissioned a World Health Organisation review of the health effects of transport-related air pollution in Europe, which found evidence that exposure to air pollutants can affect human health in a variety of ways. These include respiratory illness and allergenic illnesses, heart disease, cancer, adverse pregnancy and birth outcomes and lowering of male fertility. A recent report by the Committee on the Medical Effects of Air Pollutants (COMEAP), a panel of independent experts that advises the government, has concluded that there is a causal link between air pollutants and heart diseases. The most serious effects on health occur at the greatest frequency at the highest levels of exposure to air pollutants. Air quality limit values are set at levels which ensure this does not occur. However, the air pollutants particulate matter and ozone have no exposure threshold levels below which adverse human health effects do not occur. Although such thresholds can be established for individuals, the wide range of susceptibilities within a population, makes it impossible to define a more widely applicable threshold value. As a result, the derived air quality limit values for ‘non-threshold’ air pollutants are arbitrary, as significant public health benefits could be obtained by reductions in the pollutants both above and below the set limit. Diunduhdari: www.parliament.uk/briefing-papers/POST-PN-272.pdf………. 9/1/2013

34. AIR QUALITY & HUMAN HEALTH Susceptibility to Air Pollutants The surface of the human lung is covered by a thin layer of fluid containing various defences to protect its cells from damage6. Once levels of air pollutants overwhelm these defences, the cells become damaged triggering an inflammatory response. Inflammatory effects can spread throughout the body, although in the case of particulates, it is not clear whether this is the result of air pollutants directly entering the blood stream in the lung, local production of inflammatory factors or a combination of both. It has also been proposed that particulate pollutants can enter the nervous system through nerve endings in the nose, causing effects in the brain. Factors that affect individual susceptibility to adverse health effects include age, health status, diet and genetic background. In particular, groups such as asthmatics or those with other pre-existing diseases (such as chronic obstructive pulmonary disease) may be more susceptible to an inflammatory response at lower air pollution levels. The most severe effects occur in the most susceptible individuals, and are reflected in the daily number of deaths occurring. Children are also particularly vulnerable as the process of lung growth and development continues until adolescence, and they have incomplete metabolic systems, immature immune defences and higher breathing rates than adults. Diunduhdari: www.parliament.uk/briefing-papers/POST-PN-272.pdf ………. 9/1/2013