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                                                                                                                                                                                                                                                                                         Boogeyman
                    Toxicology Demystified
                     – Understanding Safety &
               Health Risks in the Workplace

               Keng-
               Keng-Meng Khoo, PhD, LLM (Commercial Law),
               Regulatory Affairs Regional Director (Asia Pacific,
               Africa, Middle East & Turkey)




                                                                                                                                                                                                                 1                                                                       March 16, 2012                                                                                                                                                                                   2




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               Boogeyman                                                                                                                                                                                                                                                                     Perception of safety risks
                                                                                                                                                                                                                                                                                             (real or imaginary)
                                                                                                                                                                                                                                                                                             can be very emotive!!!

                                                                                                                                                                  Boogeyman – an amorphous imaginary being
                                                                                                                                                                  used by adults to frighten children into
                                                                                                                                                                  behaving.

                                                                                                                                                                  The monster has no specific appearance, and
                                                                                                                                                                  conceptions about it can vary drastically from
                                                                                                                                                                  household to household within the same
                                                                                                                                                                  community; in many cases, he has no set
                 Goya's "Here Comes the Boogey-Man"                                                                                                               appearance in the mind of an adult or child,
                 (Aquí viene el Coco) c.1797                                                                                                                      but is simply a non-specific embodiment of
                                                                                                                                                                  terror.

                                                                                                                                                                  - Wikipedia

               March 16, 2012                                                                                                                                                                                   3                                                                        March 16, 2012                                                                                                                                                                                   4




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Boogeyman
               Risk Perception                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Revealed!
                  Risk perception by consumer/customer must not be
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Why what is real and what
                     underestimated!                                                                                                                                                                                                                                                                                                                                                                                                                                                                          is perceived matters!

                                       It does matter!                                                                                                                                                                                                                                                                                                                                                                                                                                                        Why even a basic
                                       Basis of media attention and political pressure, which both affect                                                                                                                                                                                                                                                                                                                                                                                                     understanding of safety
                                       regulation!                                                                                                                                                                                                                                                                                                                                                                                                                                                            and toxicology matters!

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Why education and
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              awareness matters!

                                                                                                                                                                                                                                    We have a B-2-B model -                                                                                                                                                                                                                                                   Why I am here today!

                                                                                                                                                                                                                                    BUT whether the customer is                          Child working in a lead battery recycling factory,
                                                                                                                                                                                                                                    from retail or institutional, their                  Bangladesh
                                                                                                                                                                                                                                    perception matters!                                  (Still Pictures/Peter Arnold Inc)

                                                                                                                                                                                                                                                                                          This child will suffer from the effects of lead poisoning for a lifetime
                                                                                                                                                                                                                                                                                          and will not be able to reach his intellectual potential!

               March 16, 2012                                                                                                                                                                                   5                                                                        March 16, 2012                                                                                                                                                                                   6




                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     3/16/2012                          1
Power To Discover The Truth                  Daily Encounters with Chemicals

 “It is not the truth that makes you          • We encounter chemicals almost every day
   free. It is your possession of the                         - Filling your car with petrol
   power to discover the truth. Our                           - Cleaning the bathroom or kitchen
                                                              - Applying pesticides
   dilemma is that we do not know                             - Using cleaning products at work
   how to provide that power.”                                - Formulating in the lab

 Richard Lewontin                             Chemicals can cause injury or illness if not handled
                                                properly!
   (New York Review of Books, Jan 7, 1997)
                                              Even water can kill under certain circumstances!!!
March 16, 2012                7              March 16, 2012                          8




Hazard vs Risk?                              Key Words To Understand!
                                   Hazard
                                                                Dose / Response / Route

                                                                       Risk =
                                                                 Hazard X Exposure

                                                                   Individual Sensitivity
                 Risk
March 16, 2012                9              March 16, 2012                          10




Key Words To Understand!                     Key Words To Understand!
                                               We routinely combine our knowledge
      Hazard = Intrinsic properties of
                                                 of hazard, exposure and individual
      a particular agent or situation         susceptibility to judge the risk of harm!

     We know the                             -      Young person judges the speed of
                                                   approaching car and decides to run across
      hazards of                                   the street!
                                             -        Old person waits for traffic light to change!
     crossing the
                                             -      Decision based on judgment about the risk
      highways!                                    of being hit by car!

March 16, 2012                11             March 16, 2012                          12




                                                                                          3/16/2012   2
Key Words To Understand!                                                     Key Words To Understand!
       Formal process of determining the potential
        of an agent/chemical/ingredient to cause                                              What is hazard classification?
             harm = risk/safety assessment                                   •      A standard and harmonized system to describe and classify
                                                                                   against agreed limits, hazard properties with potential danger
- Process is complex and often controversial                                       to man or the environment
  because data may not be available or there is
  conflicting information!                                                   •     Constitutes the basis of safety labeling to warn the user
                                                                                   about potential hazards
- Process combines all known information about the
  hazards and determine the potential for harm !                             •      GHS is a hazard-based classification system
- Risk/Safety assessment is not an ABSOLUTE and
  depends on data available at the time and the
                                                                             Reminder: HAZARD is different from RISK!
  subject matter expert

March 16, 2012                              13                               March 16, 2012                       14




Key Words To Understand!                                                     Paracelsus

                  Risk, Hazard & Risk Perception in
                             Cosmetics
                                                                                          “All substances are poisons;
-     Market for sunscreens in EU April 2001 – media attention and
                                                                                       there is none which is not a poison.
      consumer anxiety                                                                The right dose differentiates a poison
-     Article by Schlumpf et al (2001) suggesting several sunscreens have
      estrogenic activity (HAZARD!) from an in vitro test with cancer cell                       from a remedy.”
      line and an in vivo rat uterotrophic assay
-     Controversial interpretations of the results (RISK FOR HUMAN
      HEALTH!) caused consumer concerns                                                         Paracelsus (1493-1541)
-     In actual fact, the activity found in Schlumpf et al was very low
      compared to exposure with estrogenic substances in food
      (flavonoids) and current hormonal therapy (e.g. birth control pill,
      morning after pill, post menopausal therapy)

March 16, 2012                              15                               March 16, 2012                       16




                                                                             Childhood Lead Exposure
Examples of Why Safety and Toxicology
Matters


                 Childhood Lead Exposure
                                                                                      “Lead Makes the Mind
                 Organic Mercury in Fish
                                                                                           Give Way”
                 From S. Gilbert’s Principles of Toxicology

                                                                                              Dioscorides, 2nd BC


March 16, 2012                              17                               March 16, 2012                       18




                                                                                                                       3/16/2012                    3
Blood Lead Levels                                                                                            Organic Mercury in Fish

                               Acceptable Childhood Blood Lead Levels

                                40
                                       40
                                                                                                             Discharge in Minamata Bay,
          Blood Lead (ug/dl)




                                35
                                30
                                              30
                                                      25
                                                                                                             Japan
                                25
                                                             20
                                20
                                                                       15
                                15
                                                                              10
                                10
                                 5
                                 0
                                     CDC    CDC     CDC    WHO       EPA    CDC
                                     1973   1975    1985   1986      1986   1990
                                                   Agency and Year




 The CDC set the blood lead level of concern
 for children at 10 micrograms per deciliter,
 but also states that adverse effects exist at
 all levels!


March 16, 2012                                                                     19                        March 16, 2012                              20




                                                                                                             Toxicity ranked by amount that causes
Fetal Effects of MeHg
                                                                                                             death
                                                                                                                          What is LD-50?

                                                                                                                              Agent                           LD-
                                                                                                                                                              LD-50 (mg/kg)

                                                                                                                              Ethyl alcohol                   10,000
                                                                                                                              Salt (sodium chloride)          4,000
                                                                                                                              Iron (Ferrous sulfate)          1,500
                                                                                                                              Morphine                        900
                                                                                                                              Mothballs                       500
                                                                                                                                (paradichlorobenzene)
                                                                                                                              Aspirin                         250
                                                                                                                              DDT                             250
                                                                                                                              Cyanide                         10
                                                                                                                              Nicotine                        1
                                                                                        Life-long effects!                    Tetrodotoxin (from fish)        0.01
                                                                                                                              Dioxin (TCDD)                   0.001
                                                                                                                              Botulinum Toxin                 0.00001


March 16, 2012                                                                     21                        March 16, 2012                              22




Exposure & Absorption                                                                                        Frequency Of Exposure

                                                                                                                         7 Beers in 1 Hour or
                                 Route of exposure                                                                       7 Beers in 1 Week (1 Beer/Day)

                                             1) Skin (dermal)                                                            1 or 7 Cups of Coffee in 1 Day
                                             2) Lung (inhalation)
                                             3) Oral (gut)
                                                                                                                        Harmful effects of a chemical are often dependent on the frequency
                                                                                                                        of exposure and the time between exposures!


March 16, 2012                                                                     23                        March 16, 2012                              24




                                                                                                                                                              3/16/2012                      4
Distribution                                                                      Metabolism

                                                                                        How The Body Breaks The
                 Where A Chemical Goes                                                  Chemical Down?
                   (body water, fat, bone)
                                                                                          What The Chemical Turns
                 Where A Chemical                                                         Into?
                 Accumulates
                                                                                          How Fast?

March 16, 2012                        25                                          March 16, 2012                   26




                                                                                  Communicating Information – Why
Communicating Information                                                         Training on Chemical Safety/Risk?
                                                                                  •       Regulators and customers may want to have
•         Product labels                                                                 information about potential harms (right to know):
           - Hazard, risk, directions for use, safety                                    - foreseeable use
           precautions                                                                      - foreseeable misuse
                                                                                            - accident situations
•         Safety data sheets
           - Usually for use at work (occupational setting)                       •       Need to differentiate between hazard vs risk to avoid:
           - Available to public on request                                              - confusion that the same chemical is more toxic than
                                                                                         previously due to a change in hazard classification
•         Other means                                                                    (GHS)
           - Package inserts                                                             - clarify that although chemical has intrinsic
           - Internet                                                                    properties/toxicity, proper safety training on handling
                                                                                         will minimize risk (exposure to chemical hazards)
March 16, 2012                        27                                          March 16, 2012                   28




Hazard Communication                                                              Safe Handling and Use
Examples of Chemical Hazards                                                      PPE (Personal Protection Equipment)
Physical Hazards:                                                                        - Dust masks and respirators
- Flammable
- Explosive                                                                              - Glasses, goggles, and face shields
- Reactive                                                                               - Gloves
                                                                                         - Foot protection
Health Hazards:                                                                          - Aprons or full-body suits
- Corrosive
- Toxic
                                                                                  Use PPE correctly and under the appropriate circumstances!
Hazards do not inform user of the risk – If handled in an unsafe manner, risk
   of exposure to hazards (intrinsic toxicity of chemicals) is high; if handled
   in a safe manner, risk is low although the intrinsic properties may be
   high!

Training on understanding risk/hazard and safe use is a value-add to
    customers!
March 16, 2012                        29                                          March 16, 2012                   30




                                                                                                                        3/16/2012                  5
Safe Handling and Use                                                  Safe Handling and Use
First Aid Instructions                                                 Spills and Leaks

        - Eyes: Flush with water for 15 minutes                                - Evacuate the area
        - Skin: Wash with soap and water                                       - Notify a supervisor or the emergency response team
        - Inhalation: Move to fresh air
        - Swallowing: Get emergency medical assistance                 Sometimes accidents happen and users need to be aware
                                                                       of what to do under those circumstances!
Sometimes accidents happen and users need to be aware
of what to do under those circumstances!




 March 16, 2012                       31                                March 16, 2012                         32




 Importance of Labels                                                   Importance of MSDS
- Identity of the chemical                                             - Chemical and manufacturer’s identity
- Name, address and emergency phone number of the                      - Hazardous raw materials
manufacturer                                                           - Physical and chemical characteristics
                                                                       - Fire, explosion, and reactivity
- Physical and health hazards
- Special handling instructions                                        - Health hazards
- Basic PPE recommendations                                                - Routes of entry
- First aid, fire response, spill cleanup                                  - Exposure levels (PEL or TLV)
                                                                           - Symptoms of exposure
                                                                           - First-Aid and emergency information
The label will not communicate the degree of risk!
How safe is the use of the product?
                                                                       - Personal Protective Equipment (PPE)
Depends on the nature of the hazards and potential                     - Safe handling and storage
   exposure (exposure minimal if safety precautions are                - Spills and leaks
   taken)!                                                             - Compliance issues

Value-add of such communication to customer!                           Like label, does not communicate the degree of risk!
 March 16, 2012                       33                                March 16, 2012                         34




 Hazard Communication Summary                                           When to submit for safety assessment
                                                                        Formulation
                                                                                If formulation is leveraged from an EU/US product (e.g. MNC), can
Train customers on:                                                             typically leverage on the safety assessment from those regions – no
- Identify chemical hazards by reading labels and MSDSs                         need to reinvent the wheel
- Follow warnings and instructions, or ask supervisor if in doubt               If a formulation is tweaked (e.g. introduction of a new ingredient)
- Use the correct personal protective equipment                                 If the formulation is the same (leveraged from EU/US) but RM sources
- Practice sensible, safe work habits                                           change due to cost-improvement projects (e.g. change to China
- Learn emergency procedures                                                    ingredient supplier) – safety review of the RM
                                                                                Is there any contaminants/traces/impurities of concern?

Label or MSDS does not communicate the degree of risk!
                                                                            A single RM switch may not be a concern for a finished product but if
                                                                              there are multiple switches, there may be a concern for
If asked how safe is the product?                                             contaminants/traces/impurities
Answer would be if follow the proper precautions as above, the
     safety risk can be minimized – every chemical will have its own
                                                                            E.g. Heavy metal content in mined materials (talc)
     intrinsic hazards and no chemical is 100% safe
                                                                                 Pesticide content in plant-based ingredients
                                                                                BSE statement (certificate of origin) for animal-based ingredients
Safe use depends on awareness of hazards and practicing sensible,
                                                                              (statements to confirm that a product is “free of TSE/BSE” are not
safe work habits to minimize safety risk!                                     scientifically possible)
 March 16, 2012                       35                                March 16, 2012                         36




                                                                                                                    3/16/2012                          6
Post-
Post-marketing surveillance
                                                   Power To Discover The Truth
        Once a product is cleared for use, it is
        important to monitor adverse reactions      “It is not the truth that makes you
        when it enters the market place
                                                      free. It is your possession of the
        Continuous confirmation to give consumer
                                                      power to discover the truth. Our
        the level of safety reasonably expected       dilemma is that we do not know
                                                      how to provide that power.”
                                                    Richard Lewontin
                                                      (New York Review of Books, Jan 7, 1997)


March 16, 2012               37                    March 16, 2012                38




March 16, 2012               39




                                                                                      3/16/2012   7

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Toxicology Demystified: Understanding Safety & Health Risks in the Workplace

  • 1. To help protect y our priv acy , PowerPoint prev ented this external picture from being automatically downloaded. To download and display this picture, click Options in the Message Bar, and then click Enable external content. Boogeyman Toxicology Demystified – Understanding Safety & Health Risks in the Workplace Keng- Keng-Meng Khoo, PhD, LLM (Commercial Law), Regulatory Affairs Regional Director (Asia Pacific, Africa, Middle East & Turkey) 1 March 16, 2012 2 To help protect y our priv acy , PowerPoint prev ented this external picture from being automatically downloaded. To download and display this picture, click Options in the Message Bar, and then click Enable external content. Boogeyman Perception of safety risks (real or imaginary) can be very emotive!!! Boogeyman – an amorphous imaginary being used by adults to frighten children into behaving. The monster has no specific appearance, and conceptions about it can vary drastically from household to household within the same community; in many cases, he has no set Goya's "Here Comes the Boogey-Man" appearance in the mind of an adult or child, (Aquí viene el Coco) c.1797 but is simply a non-specific embodiment of terror. - Wikipedia March 16, 2012 3 March 16, 2012 4 Boogeyman Risk Perception Revealed! Risk perception by consumer/customer must not be Why what is real and what underestimated! is perceived matters! It does matter! Why even a basic Basis of media attention and political pressure, which both affect understanding of safety regulation! and toxicology matters! Why education and awareness matters! We have a B-2-B model - Why I am here today! BUT whether the customer is Child working in a lead battery recycling factory, from retail or institutional, their Bangladesh perception matters! (Still Pictures/Peter Arnold Inc) This child will suffer from the effects of lead poisoning for a lifetime and will not be able to reach his intellectual potential! March 16, 2012 5 March 16, 2012 6 3/16/2012 1
  • 2. Power To Discover The Truth Daily Encounters with Chemicals “It is not the truth that makes you • We encounter chemicals almost every day free. It is your possession of the - Filling your car with petrol power to discover the truth. Our - Cleaning the bathroom or kitchen - Applying pesticides dilemma is that we do not know - Using cleaning products at work how to provide that power.” - Formulating in the lab Richard Lewontin Chemicals can cause injury or illness if not handled properly! (New York Review of Books, Jan 7, 1997) Even water can kill under certain circumstances!!! March 16, 2012 7 March 16, 2012 8 Hazard vs Risk? Key Words To Understand! Hazard Dose / Response / Route Risk = Hazard X Exposure Individual Sensitivity Risk March 16, 2012 9 March 16, 2012 10 Key Words To Understand! Key Words To Understand! We routinely combine our knowledge Hazard = Intrinsic properties of of hazard, exposure and individual a particular agent or situation susceptibility to judge the risk of harm! We know the - Young person judges the speed of approaching car and decides to run across hazards of the street! - Old person waits for traffic light to change! crossing the - Decision based on judgment about the risk highways! of being hit by car! March 16, 2012 11 March 16, 2012 12 3/16/2012 2
  • 3. Key Words To Understand! Key Words To Understand! Formal process of determining the potential of an agent/chemical/ingredient to cause What is hazard classification? harm = risk/safety assessment • A standard and harmonized system to describe and classify against agreed limits, hazard properties with potential danger - Process is complex and often controversial to man or the environment because data may not be available or there is conflicting information! • Constitutes the basis of safety labeling to warn the user about potential hazards - Process combines all known information about the hazards and determine the potential for harm ! • GHS is a hazard-based classification system - Risk/Safety assessment is not an ABSOLUTE and depends on data available at the time and the Reminder: HAZARD is different from RISK! subject matter expert March 16, 2012 13 March 16, 2012 14 Key Words To Understand! Paracelsus Risk, Hazard & Risk Perception in Cosmetics “All substances are poisons; - Market for sunscreens in EU April 2001 – media attention and there is none which is not a poison. consumer anxiety The right dose differentiates a poison - Article by Schlumpf et al (2001) suggesting several sunscreens have estrogenic activity (HAZARD!) from an in vitro test with cancer cell from a remedy.” line and an in vivo rat uterotrophic assay - Controversial interpretations of the results (RISK FOR HUMAN HEALTH!) caused consumer concerns Paracelsus (1493-1541) - In actual fact, the activity found in Schlumpf et al was very low compared to exposure with estrogenic substances in food (flavonoids) and current hormonal therapy (e.g. birth control pill, morning after pill, post menopausal therapy) March 16, 2012 15 March 16, 2012 16 Childhood Lead Exposure Examples of Why Safety and Toxicology Matters Childhood Lead Exposure “Lead Makes the Mind Organic Mercury in Fish Give Way” From S. Gilbert’s Principles of Toxicology Dioscorides, 2nd BC March 16, 2012 17 March 16, 2012 18 3/16/2012 3
  • 4. Blood Lead Levels Organic Mercury in Fish Acceptable Childhood Blood Lead Levels 40 40 Discharge in Minamata Bay, Blood Lead (ug/dl) 35 30 30 25 Japan 25 20 20 15 15 10 10 5 0 CDC CDC CDC WHO EPA CDC 1973 1975 1985 1986 1986 1990 Agency and Year The CDC set the blood lead level of concern for children at 10 micrograms per deciliter, but also states that adverse effects exist at all levels! March 16, 2012 19 March 16, 2012 20 Toxicity ranked by amount that causes Fetal Effects of MeHg death What is LD-50? Agent LD- LD-50 (mg/kg) Ethyl alcohol 10,000 Salt (sodium chloride) 4,000 Iron (Ferrous sulfate) 1,500 Morphine 900 Mothballs 500 (paradichlorobenzene) Aspirin 250 DDT 250 Cyanide 10 Nicotine 1 Life-long effects! Tetrodotoxin (from fish) 0.01 Dioxin (TCDD) 0.001 Botulinum Toxin 0.00001 March 16, 2012 21 March 16, 2012 22 Exposure & Absorption Frequency Of Exposure 7 Beers in 1 Hour or Route of exposure 7 Beers in 1 Week (1 Beer/Day) 1) Skin (dermal) 1 or 7 Cups of Coffee in 1 Day 2) Lung (inhalation) 3) Oral (gut) Harmful effects of a chemical are often dependent on the frequency of exposure and the time between exposures! March 16, 2012 23 March 16, 2012 24 3/16/2012 4
  • 5. Distribution Metabolism How The Body Breaks The Where A Chemical Goes Chemical Down? (body water, fat, bone) What The Chemical Turns Where A Chemical Into? Accumulates How Fast? March 16, 2012 25 March 16, 2012 26 Communicating Information – Why Communicating Information Training on Chemical Safety/Risk? • Regulators and customers may want to have • Product labels information about potential harms (right to know): - Hazard, risk, directions for use, safety - foreseeable use precautions - foreseeable misuse - accident situations • Safety data sheets - Usually for use at work (occupational setting) • Need to differentiate between hazard vs risk to avoid: - Available to public on request - confusion that the same chemical is more toxic than previously due to a change in hazard classification • Other means (GHS) - Package inserts - clarify that although chemical has intrinsic - Internet properties/toxicity, proper safety training on handling will minimize risk (exposure to chemical hazards) March 16, 2012 27 March 16, 2012 28 Hazard Communication Safe Handling and Use Examples of Chemical Hazards PPE (Personal Protection Equipment) Physical Hazards: - Dust masks and respirators - Flammable - Explosive - Glasses, goggles, and face shields - Reactive - Gloves - Foot protection Health Hazards: - Aprons or full-body suits - Corrosive - Toxic Use PPE correctly and under the appropriate circumstances! Hazards do not inform user of the risk – If handled in an unsafe manner, risk of exposure to hazards (intrinsic toxicity of chemicals) is high; if handled in a safe manner, risk is low although the intrinsic properties may be high! Training on understanding risk/hazard and safe use is a value-add to customers! March 16, 2012 29 March 16, 2012 30 3/16/2012 5
  • 6. Safe Handling and Use Safe Handling and Use First Aid Instructions Spills and Leaks - Eyes: Flush with water for 15 minutes - Evacuate the area - Skin: Wash with soap and water - Notify a supervisor or the emergency response team - Inhalation: Move to fresh air - Swallowing: Get emergency medical assistance Sometimes accidents happen and users need to be aware of what to do under those circumstances! Sometimes accidents happen and users need to be aware of what to do under those circumstances! March 16, 2012 31 March 16, 2012 32 Importance of Labels Importance of MSDS - Identity of the chemical - Chemical and manufacturer’s identity - Name, address and emergency phone number of the - Hazardous raw materials manufacturer - Physical and chemical characteristics - Fire, explosion, and reactivity - Physical and health hazards - Special handling instructions - Health hazards - Basic PPE recommendations - Routes of entry - First aid, fire response, spill cleanup - Exposure levels (PEL or TLV) - Symptoms of exposure - First-Aid and emergency information The label will not communicate the degree of risk! How safe is the use of the product? - Personal Protective Equipment (PPE) Depends on the nature of the hazards and potential - Safe handling and storage exposure (exposure minimal if safety precautions are - Spills and leaks taken)! - Compliance issues Value-add of such communication to customer! Like label, does not communicate the degree of risk! March 16, 2012 33 March 16, 2012 34 Hazard Communication Summary When to submit for safety assessment Formulation If formulation is leveraged from an EU/US product (e.g. MNC), can Train customers on: typically leverage on the safety assessment from those regions – no - Identify chemical hazards by reading labels and MSDSs need to reinvent the wheel - Follow warnings and instructions, or ask supervisor if in doubt If a formulation is tweaked (e.g. introduction of a new ingredient) - Use the correct personal protective equipment If the formulation is the same (leveraged from EU/US) but RM sources - Practice sensible, safe work habits change due to cost-improvement projects (e.g. change to China - Learn emergency procedures ingredient supplier) – safety review of the RM Is there any contaminants/traces/impurities of concern? Label or MSDS does not communicate the degree of risk! A single RM switch may not be a concern for a finished product but if there are multiple switches, there may be a concern for If asked how safe is the product? contaminants/traces/impurities Answer would be if follow the proper precautions as above, the safety risk can be minimized – every chemical will have its own E.g. Heavy metal content in mined materials (talc) intrinsic hazards and no chemical is 100% safe Pesticide content in plant-based ingredients BSE statement (certificate of origin) for animal-based ingredients Safe use depends on awareness of hazards and practicing sensible, (statements to confirm that a product is “free of TSE/BSE” are not safe work habits to minimize safety risk! scientifically possible) March 16, 2012 35 March 16, 2012 36 3/16/2012 6
  • 7. Post- Post-marketing surveillance Power To Discover The Truth Once a product is cleared for use, it is important to monitor adverse reactions “It is not the truth that makes you when it enters the market place free. It is your possession of the Continuous confirmation to give consumer power to discover the truth. Our the level of safety reasonably expected dilemma is that we do not know how to provide that power.” Richard Lewontin (New York Review of Books, Jan 7, 1997) March 16, 2012 37 March 16, 2012 38 March 16, 2012 39 3/16/2012 7