1. POLICY PRACTICE AND SUSTAINABILITY (1) January 16, 2004 Lynn R. Goldman, MD, MPH

2. Topics to Cover Policies for safe food and clean environment (especially pesticides) Food Standards USA vs. the World

3. Historical overview – pesticides in US

4. 1947: FIFRA Enacted in 1947 Initially a consumer protection statute (for farmers)

5. 1962: Silent Spring “One of the most sinister features of DDT and related chemicals is the way they are passed on from one organism to another through all the links of the food chain." Rachel Carson, 1962

6. 1970s FIFRA transferred to EPA in 1972 Bans/severe restrictions on DDT, aldrin, dieldrin, endrin, chlordane, heptachlor, toxaphene, DBCP, EDB and other highly chlorinated and brominated pesticides. Most lead, arsenic and thallium pesticides were banned/severely restricted as well Usage of other insecticides, e.g., organophosphates and carbamates, increased sharply

7. 1980s: Signs of trouble Dioxins contaminating Agent Orange In the 1970s, DBCP caused sterility among male pesticide-manufacturing workers 1980s, epidemic of bladder cancer in workers after exposure to chlordimeform, first registered for use in the United States in 1968. 1960s through 1980s, epidemics of severe accidental pesticide-related poisonings due to organophosphate pesticides (e.g., with parathion, mevinphos)

8. FIFRA reform 1972 Comprehensive reform establishes FIFRA as public health law and sets goals of reassessing older pesticides and protection of farmworkers 1988 FIFRA amendments require evaluation of all pesticides, old and new, using a robust set of toxicological tests and modern analytical methods, on a schedule. Evaluations include stricter worker protection measures 1992 EPA worker protection standard 1996 FQPA requires assessment of risks to children, on a schedule and with new health based standards

9. Informing Decisions about Risk Risk assessment does not provide answers, but is an essential component of informed decisions about risks

10. Expectations Framework for Decisions Common Currency Tool for Priority Setting Separate Politics from Science Improved Understanding of Risks by Policymakers and Public Communication Tool Improved Risk Management

11. Using Risk To Make Decisions A common measure of harm Estimable for individuals and populations Compare across events Bound acceptable and unacceptable risks Comparative risk Compare risks to set priorities Evaluate risk trade-offs Optimize resource allocation Regulatory uses An index for action Public health implications

12. Criteria for Decision Making Risk Only Risk-Risk (Risk / Benefit Balancing) Risk-Technical Feasibility

13. Risk Management Command and Control: federal environmental and health statutes regulations and standards (federal, state, local) new chemicals notifications and pesticide registrations and tolerances permitting of facilities for air emissions, water discharges, and waste disposal enforcement of standards reporting and monitoring

14. Information for Risk Management Risk analysis Technology/process analysis, including pollution prevention Economic analysis Information Investigation

15. Targets for Risk Management Carcinogens General Population Precedents - One per 1,000,000 and lower generally considered “Negligible” Range of one per 10,000 down to one per 1,000,000 found tolerable in many cases One per 10,000 and above generally found unacceptable (but many occupational standards are well above this) Zero Risk is applied to direct food additives (Delaney Clause)

16. Targets for Risk Management Non-Carcinogens Acceptable Daily Intake ( ADI ) Reference Dose ( RfD ) “Reasonable certainty of no harm” (FDA and pesticides at EPA) Priority Pollutants (CAA) Ecological Risks: Margin of Exposure Approach

17. Alternative Approaches Hazard Only (e.g., Delaney Clause) Level of Contaminant (e.g., European Union Pesticide Groundwater Reg - 1ppb) The choice of how to evaluate hazards is itself a risk management decision

18. Food Safety Standards USDA: pathogens on meat and poultry FDA: pathogens in eggs, milk, fish, processed foods; food additives and vet drugs EPA: pesticides CDC monitors incidence of foodborne illness US standards apply to imported as well as to domestically produced foods

19. Food Additives and Vet Drugs Regulated by the FDA under FFDCA FDA sets “tolerances” for allowable levels and enforces these by monitoring the food supply; USDA enforces them for chicken and beef Approval process is much as for pesticides only there is no renewal of approvals, different testing requirements and there is a GRAS (generally regarded as safe) list for older additives “grand fathered” in by law.

20. Setting Tolerances Toxicity and exposure data are required of manufacturer NOAEL determined RfD or ADI established Divide NOAEL by uncertainty factors (how much?)

21. Pathogens and Other Contaminants Regulated by both USDA (beef and chickens) and FDA (fish, eggs, milk, fruits and vegetables, processed foods); both agencies now moving to risk based standards (and away from look and smell) Inspection of slaughter and processing plants an important component: FDA vs USDA Surveillance of foodborne illness by CDC

22. Problem of Coordination Outbreaks today are often multistate and do not have a clear origin New sources are being identified, e.g., apple juice, alfalfa sprouts for E. Coli and imported raspberries and strawberries for cyclospora, hotdogs for listeria There are huge resource inequities in appropriations -- USDA vs FDA

23. Stakeholder Pressures Call for a new Food Safety Agency Families with E. Coli deaths organize to lobby for stronger protections Congress holds hearings and expresses concerns about need for coordination Congress directed NAS to do a study: Ensuring Food Safety from Production to Consumption

24. Ensuring Safe Food from Production to Consumption: 1998 NAS Conclusions An effective and efficient food safety system must be based in science To achieve a food safety based in science requires revision of statutes governing food safety regulation and management To implement a science-based system, reorganization of federal food safety efforts is required

25. Ensuring Safe Food from Production to Consumption: 1998 NAS Findings Inconsistent, uneven, archaic food statutes 12 agencies and 35 statutes, with lack of adequate coordination inadequate federal/state/local coordination no focus for federal leadership food safety agencies lack similar missions inadequate surveillance efforts inadequate research $$$ to support science based effort limited consumer knowledge lack of nationwide adherence to minimum standards

26. Pesticide Registration and Tolerance Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Federal Food, Drug, and Cosmetic Act (FFDCA) Tolerances: maximum amount of pesticide residue permitted on foods Note: FQPA midway through FIFRA ‘88 (800 pesticides, 30,000 studies)

27. Pesticides in the Diets of Infants and Children 1993 Report from National Academy of Sciences National Research Council Concluded that the EPA inadequately assessed hazards and exposures to children Led to the enactment of the Food Quality Protection Act of 1996

28. Reassessment of pesticides under FQPA

29. Cumulative and aggregate risk Aggregate Risk: The same pesticide with multiple exposure pathways (e.g., present in food, drinking water, and/or household products) Cumulative Risk: Multiple pesticides that act via a similar mechanism (e.g., OP’s, triazines, organochlorines)

30. FQPA 10x kids factor EPA is required to apply a 10X FQPA safety factor (in addition to the traditional 10X uncertainty factors for interspecies and intraspecies extrapolation) unless there are sufficient toxicity and exposure data to ensure that children will be safe

31. Hazard data Reregistration of pesticides (1988 law); so called “REDs” are available on line (Reregistration Eligibility Documents) Tolerance reassessments (1996 law); EPA must publish a finding showing how it concluded “a reasonable certainty of no harm” (Federal Register) EPA FIFRA Science Advisory Panel (www.epa.gov/pesticides)

32. Pesticide Developmental Toxicants Uses in 1995 Agricultural (conventional) pesticide use = 939 million lbs. Of Top 25, 11 (204 million lbs.) are recognized or suspected to have the potential to cause developmental toxicity Household (conventional) pesticides = 74 million lbs. Of Top 10, 3 (11 million lbs.) are suspected to have the potential to cause developmental toxicity Source: Goldman 1999

33. Organophosphates & carbamates Insecticides: 40 OPs in the U.S. Inhibit acetyl cholinesterase Carbamates share mechanism of action Acute and chronic toxicity Specific concern re: developmental neurotoxicity Food, lawn and household use pesticides (e.g., malathion, chlorpyrifos, aldicarb)

34. Developmental neurotoxicity of OPs Are neurotoxic pesticides especially harmful to developing brains? Certain neurotoxic chemicals (PCBs, lead and methylmercury) are 1000 fold more toxic to the developing brain than to adult animals. EPA has called in data on developmental neurotoxicity of organophosphate pesticides. OPs modulate DNA expression in the developing brain, possibly at levels below those that cause acetyl cholinesterase inhibition

35. Case example: Chlorpyrifos Until 1996, commonly used insecticide for agriculture and household uses including termites, fleas, roach and garden; household exposures to children were significant especially from broadcast uses. Also, was the number one cause of childhood poisonings reported by PCC’s Aggregate exposure to children at all ages and to women, from food uses only, were of concern Since the enactment of FQPA, most residential uses have been banned and numerous food uses were eliminated or reduced Aggregate risk now “acceptable”

36. Cumulative risk of OP’s EPA’s draft cumulative risk assessment indicates that overall exposures to cholinesterase inhibiting pesticides are two times above regulatory limits for the upper 0.1% of kids Assessment does not account for developmental neurotoxicity Assessment employs a 3X FQPA factor, which many feel is inadequately protective

37. When will pesticides be “safe” under FQPA? Food Quality Protection Act: Deadline for reassessments is 2006 However, they are going after the riskiest pesticides first and initial actions have focused on kid’s foods Meanwhile, baby food companies and others are voluntarily moving away from organophosphates and other pesticides that are likely to be problematic

38. International Food Safety Issues Sanitary and Phytosanitary Standards (SPS) International process under Codex Alimentarium to harmonize between countries (under UN agencies -- FAO and WHO) Concern about balance between national SPS standards vs. free trade Trade barriers can masquerade as standards Free trade policies can threaten standards

39. International risk management Codex Collaborative between World Health Organization and Food and Agriculture Organization Internationally accepted food safety standards, called “MRLs” Maximum Residue Levels Recognized as an authoritative body by the World Trade Organization and thus more powerful, since 1995, than before

40. International Food Safety Issues Beef Hormones US beef excluded from Europe due to standards Europe lost in the World Trade Organization, which concluded that neither EU nor US standards had a strong basis and that the EU standards were discriminatory. EU is redoing standards in order to exclude US beef

41. International Food Safety Issues Genetically modified foods In Biosafety protocol under the Biodiversity Convention, blocked by several nations In trade friction with Europe and possibility of challenge under the World Trade Organization Issue involves safety concerns, cultural concerns and right to know

42. International Food Safety Issues Distrust of regulatory authorities e.g., Mad Cow Disease (bovine spongiform encephalopathy) in the United Kingdom. France still bans British beef] e.g., dioxins/PCBs in Belgian eggs and chickens due to contaminated used cooking fat into the animal feed supply Distrust of industry e.g., Coca Cola scare in Europe

43. Pesticides in developing countries

44. Pesticide Exports ($1,000s)

45. Occupational concerns Farmers in developing countries generally are unaware of the short and long-term hazards associated with exposures to many pesticide products. Advanced technologies such as chemical pesticide application require knowledge that goes beyond traditional agricultural practices.

46. Frequently documented unsafe practices Poor knowledge and understanding of safe pesticide use practices and deficiencies in safety training are the norm among the developing countries. Careless handling during preparation and application, Use of pesticides in concentration in excess of requirements, Consumption of food and beverage while working, Lack of personal hygiene, Laxity of safekeeping of the chemical, and Careless disposal of empty pesticide containers.

47. Poor maintenance facilities for spray equipment Occupational poisoning occurs largely during spraying, mixing and dilution of pesticides. The use of malfunctioning or defective equipment is an important factor contributing to accidental acute poisoning among agricultural workers. Poverty leads to a lack of availability of personal protective equipment. Even where available, it may be avoided due to heat related discomfort and heat stress.

48. Child labor in agriculture Most working children in developing nations are agricultural workers and the use of agricultural pesticides is widespread, Various case studies and outbreak reports have reported child workers’ exposure to hazards associated with the inappropriate use of agrochemicals; no long term follow-up has been done of these children Children also may be present because of being taken along to work or because of residential proximity of homes to fields

49. Non-occupational pesticide concerns Bystander poisonings Contamination of soil in areas where mixing and loading occurs Especially high levels of community pesticide exposure in developing countries

50. Factors resulting in excess levels in communities Excessive use Uncontrolled patterns of spraying, Open houses located to fields, Lack of washing facilities, Improper storage of pesticides in homes (under beds, on kitchen shelves), Improper use of empty containers for the storage or transfer of water, vegetable oils or food, Field re-entry delay intervals after spraying are not usually observed by workers or residents in these areas. Not observing intervals between the last pesticide application and harvesting and eating the produce, Hand washing of clothes worn by farmers during pesticide applications

51. Prior Informed Consent Rotterdam Convention on Prior Informed Consent Countries must obtain approval for export of very hazardous chemicals and pesticides (on list) Nearly in force

52. Pesticides initially in PIC Insecticides Aldrin Chlordane DDT Dieldrin HCH Heptachlor Hexachlorobenzene Lindane Methyl-parathion (some) Methamidophos Monocrotophos Parathion Phosphamidon Other Pesticides 2,4,5-T Captafol Chlorobenzilate Chlordimeform Dinoseb 1,2-Dibromoethane (EDB) Fluoroacetamide Mercury compounds Pentachlorophenol

53. POPs Environmental and food contamination, human exposure, and potential health effects are the legacy of historical use of POPs in many developing countries. Studies and ongoing monitoring of POP contamination and human exposure are limited to non-existent in most developing countries. Children in the developing countries are most vulnerable; they are exposed to POPs not only through consuming contaminated foods but also in utero and in breast milk.

54. Obsolete pesticide stocks

55. POPs obsolete stocks POPs comprise a significant portion of obsolete pesticide stockpiles in the developing countries. The cost of disposal of obsolete POPs is high and cannot be afforded by these poor developing countries.

56. Obsolete stocks health and environmental health concerns Spills and leaks from containers can find their way into surface waters from runoff or into groundwater from leaching through soil. Poor storage of obsolete stocks creates pathways to human exposure. Clearly, chronic illness, reproductive problems and birth defects as the result of such exposure would bring high long-term costs for individuals and communities. There are many examples of children playing, livestock grazing, people working, cooking, drawing water and growing food around dumped and leaked pesticides.

57. Factors that lead to the accumulation of obsolete pesticides in developing countries Product bans Inadequate storage and poor stock management Unsuitable products or packaging Donation or purchase in excess of requirements Lack of coordination between donor agencies Commercial interest of private sector and hidden factors. (FAO Obsolete Pesticides Program, 1995b)

58. Persistent Organic Pollutants – POPs UNEP has identified a short list of 12 POPs, all chlorinated compounds, as the basis for international action. They include: PCBs, dioxins, furans, aldrin, dieldrin, DDT, endrin, chlordane, hexachlorobenzene (HCB), mirex, toxaphene and heptachlor. PCBs are industrial chemicals and dioxin and furans are unwanted by-products of various technological processes Aldrin, dieldrin, DDT, endrin, chlordane, hexachlorobenzene mirex, toxaphene, and heptachlor are pesticides.

59. POPs Convention Stockholm Convention on Persistent Organic Pollutants Nearly in force Will phase out the use of most of the 12 “dirty dozen” pesticides A special provision was made for the public health (malaria) uses of DDT

60. Voluntary efforts Foreign assistance programs (e.g., US AID) FAO Code of Conduct for Pesticides Agreement among industry groups and governments regarding roles and responsibilities to prevent pesticide risks Places a large regulatory burden on government, ala the US, Canada, Europe, Australia, Japanese systems but not very realistic on a global basis

61. Pesticide alternatives Concerted efforts should be made by governments and pesticide industries to develop and promote: integrated pest management systems the use of safe, efficient, cost-effective application methods FAO Code of Conduct on Pesticides

62. Insecticide alternatives Pyrethroids New chemistries Biologicals (Bt, parasites, pheromones, genetically modified “plant incorporated protectants”)

63. The need for safer pesticides "A truly extraordinary variety of alternatives to the chemical control of insects is available," she wrote. "Some are already in use and have achieved brilliant success. Others are in the stage of laboratory testing. Still others are little more than ideas in the minds of imaginative scientists, waiting for the opportunity to put them to the test. All have this in common: they are biological solutions, based on understanding of the living organisms they seek to control, and of the whole fabric of life to which these organisms belong." Rachel Carson, 1962

64. One thing we all can do Integrated Pest Management First line of defense is keeping pests out in the first place Food, water, shelter for household pests Natural controls (biologically based) for agricultural pests Support local agriculture (e.g., Community Supported Agriculture farms)

65. Household water security A human right as defined in the General Comment on the Right to Water and the Declaration on the Rights of the Child. Safety, hand washing, food hygiene, laundry and general household hygiene. Diarrhea, the second biggest child-killer in the world. Estimated to cause 1.3 million child deaths per year - about 12% of total deaths of children under five in developing countries. Other infectious diseases with similar patterns of transmission include hepatitis A and E, dysentery, cholera and typhoid fever. Skin and eye infections including trachoma, and with schistosomiasis, which may be acquired whilst collecting water from infested sources. WHO 2003

66. Access to safe water In 2000, WHO and UNICEF estimated that 1.1 billion people lacked access to an improved water source. The number of people without access to reliable safe water in or just outside the home is undoubtedly far greater than the number with access to an ‘improved’ source. 80% of this ‘unserved’ population live in rural areas. Women and children often have the task of fetching water.

67. Hygiene and sanitation Fecal pollution of the household and community environment -  >> diarrhea, schistosomiasis, hepatitis A and E, dysentery, cholera and typhoid fever. Lack of sanitation is also associated with infection with helminth and with trachoma. Trachoma causes irreversible blindness and today about 6 million people are visually impaired by this disease. Globally, 2.4 billion people, most of them living in peri-urban or rural areas in developing countries, do not have access to any type of improved sanitation facilities Little progress was made from 1990 to 2000 The lowest levels of coverage are found in Asia and Africa where 31% and 48% of the rural populations, respectively, do not have access to adequate sanitation facilities. WHO, 2003

68. Actions to protect children from risks from water Extending access to improved sources amongst the ‘unserved’ in rural and urban areas. Targeting hygiene education on key behaviors at both children and adults. Safe water storage at home – and treatment of water in the home when its quality is in doubt - reduces water contamination and leads to proven health benefits. Reliable safe water supply in schools has a direct impact on health and provides a model intervention serving as an educational contribution. Protecting all water resources from contamination will contribute to health (that is, not only sources of drinking water but also, for example, water used for bathing and fishing). Targeted measures in areas affected by hazardous chemicals in drinking water such as lead, fluoride and arsenic. WHO 2003

69. Actions for improved hygiene and sanitation Ensure that children have access to safe sanitary facilities and that children’s feces are safely disposed of. Adequate and separate latrines for boys and girls in schools can encourage latrine use and thus reduce disease transmission. Proper waste management and relocation of waste dumps away from human settlements protect children from scavenging and from exposure to hazards. Washing hands with soap before meals and after defecating significantly reduces the risk of diarrhoeal disease WHO 2003

70. Sustainable Development (Brundtland report) “Sustainable development is development that meets the needs of the present without compromising the ability of future generations to meet their own needs.” DON’T LEAVE A MESS FOR YOUR KIDS

71. Answers to questions Organic foods vs. cancer risks Treaties on drinking water and conflicts; other international agreements on water? Cumulative/aggregate risks for nonpesticides Importance of higher crop yields benefits versus pesticide water risks Does polluter pay for water pollution Can you prioritize pesticide/water risks?

72. Bovine Spongiform Encephalopathy Case Study Hazard: BSE or “mad cow disease” caused by prion proteins Dose response assessment: Unclear Exposure: Via consumption of beef from cow with BSE. Prions are concentrated in brain and spinal cord tissue but also are present in peripheral tissues, albeit at lower levels Risk characterization: Highly uncertain but known human cases are among people who have consumed large amounts of beef

73. US Government BSE Regulation “Since 1989, the USDA had prohibited the importation of live animals and animal products from BSE-positive countries. Since 1997 the FDA has prohibited the use of cattle and other ruminant protein in the manufacture of ruminant feed. This ban was expanded in 2001 to prohibit the use of all mammalian protein in ruminant feed. FDA continues to implement policies to keep safe all FDA-regulated products, including food, food ingredients, dietary supplements, drugs, vaccines, and cosmetics from risk of any BSE-contaminated bovine material.” Source: FDA webpage January 2004

74. WHO BSE activities Global surveillance Guidelines Regional trainings

75. New BSE Regulations (USDA) “A ban on use of live, but non-ambulatory cattle from entering the human food supply A ban on use of organs, from cattle older than 30 months, in which infectious prions occur and the tonsils and small intestine of cattle of all ages for human food Restrictions on techniques to mechanically remove meat from bones, and Meat from tested animals will not be certified as USDA-inspected until test results are final. “ Source, FDA webpage, 1/2004

76. BSE Quarantine: 2003 A U.S. trade delegation left for Mexico January 5, 2004 in another attempt to get the $1.3 billion beef export industry back on its feet after more than two dozen trading partners halted shipments when mad cow disease was found in a Washington state diary cow last month. The team visiting Mexico includes undersecretaries J.B. Penn and Bill Hawks from the U.S. Department of Agriculture. A quarantined Holstein cow is seen on the grounds of the snow- covered Sunny Dene Ranch in Mabton, Washington, December, 27, 2003. Photo by Jeff Green/Reuters

77. Harvard “Risk Assessment” 1998, the USDA commissioned the Harvard Center for Risk Analysis Concluded that if introduced, due to the preventive measures currently in place in the U.S., BSE is extremely unlikely to become established in the United States. Concluded that only a small amount of potentially infective tissues would likely reach the human food supply even if BSE were to enter the US.

78. BSE Lingering questions: Is muscle meat a source of infective prions? FDA/USDA say, no, but researchers find prions at lower levels Do current practices exclude prions from cattle feed? FDA/USDA say no, but … Brain/spinal tissue  chicken feed. Chicken floor litter (with uneaten feed)  cattle feed Are regulations adequately enforced (GAO)?

79. Consumer Demands Mandatory national system for tracing all meat animals from the slaughterhouse back to the farm of origin. A voluntary or piece meal system is not sufficient to protect either public health or consumer confidence. Increased testing for the presence of BSE (all animals over the age of three). Mandatory recall authority for USDA (supported by the previous Administration). Consumer Federation of America: 12/2003

80. BSE Discussion