Fluoride Exposure from Pesticides: The Case Against SULFURYL FLUORIDE Michael Connett, FAN 2nd...
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Transcript of Fluoride Exposure from Pesticides: The Case Against SULFURYL FLUORIDE Michael Connett, FAN 2nd...
Fluoride Exposure from Pesticides:The Case Against
SULFURYL FLUORIDE
Michael Connett, FAN2nd Citizens’ Conference on Fluoride
July 30, 2006
Which Foods Can be Fumigated with Sulfuryl Fluoride?
Dried Eggs
900 ppm
Wheat (flour & germ)
130 ppm
Oat (flour & rolled)
75 ppm
Legumes (57 types)
70 ppm
Processed Foods (ALL)
70 ppm
Barley (bran, flour, pearled)
45 ppm
Corn (meal & flour)
30 - 35 ppm
Other Tolerances
70 ppm: Herbs & Spices (135 types)40 ppm: Wheat (bran & grain)40 ppm: Millet (grain)45 ppm: Rice (flour)40 ppm: Coconut40 ppm: Cattle (meat, dried)31 ppm: Rice (bran)25 ppm: Rice (wild grain & polished)25 ppm: Oat (grain)
Allowable levels of fluoride “in or on” food:
Allowable levels of fluoride “in or on” food:
20 ppm: Cocoa bean15 ppm: Peanuts15 ppm: Coffee15 ppm: Barley (grain)10 ppm: Corn (grain)10 ppm: Tree Nuts (14 types)7 ppm: Raisin5 ppm: Cheese5 ppm: Powdered Milk3 ppm: Dried Fruit
Other Tolerances (cont.)
How Much Fluoride Will We IngestFrom Fumigated Foods?
The Daily Dose for adults
0.67 mg/dayEPA’s estimate for the average
exposure to fluoride from SF
2nd Largest Daily Source of Fluoride (EPA 2006)
The Daily Dose for children
0.08 - 0.57 mg/dayEPA’s estimate for a child’s average
exposure to fluoride from SF
2nd Largest Daily Source of Fluoride (EPA 2006)*
The Daily Dose for children
Age Avg. Dose from SF
< 1 yr 0.08 mg/day
1-2 yrs 0.26 mg/day
3-5 yrs 0.48 mg/day
6-12 yrs 0.57 mg/day
EPA, Final Health Risk Assessment, January 2006
How Did this Happen?
EPA’s Risk Assessment
Food Quality Protection Act (FQPA)
“When setting new tolerances, or reassessing existing tolerances or tolerance exemptions, EPA must now focus explicitly on exposures and risks to children and infants. EPA must,
1) explicitly determine that the tolerance is safe for children;
2) consider the need for an additional safety factor of up to ten-fold to account for uncertainty in the data base relative to children unless there is evidence that a different factor should be used; and
3) consider children's special sensitivities and often unique exposure patterns to pesticides.”
-- EPA, Federal Register, January 31, 1997
Did EPA:“explicitly determine that the tolerance
is safe for children?”FQPA Requirement
•For its risk assessment, EPA used the “MCLG” (Maximum Contaminant Level Goal)
•Set by EPA’s Office of Water in 1985.
•Vigorously criticized by Natural Resources Defense Council(NRDC) and EPA Headquarters Union.
An Adult-Based Health Standard (MCLG)
“there was a consensus that mottling or pitting of teeth could represent as yet unknown skeletal effects in children and that severe dental fluorosis per se constitutes an adverse health effect that should be prevented.”-Surgeon General’s Panel on the Non-Dental Effects ofFluoride (1983)
A glimpse into the history…
Assumption #1:Severe Dental Fluorosis is not an adverse health effect
Problems with MCLG
Assumption #2:Crippling Skeletal Fluorosis is the ONLY adverse effect
fluoride has on bone.
Problems with MCLG
Assumption #3:20 mg/day is the lowest dose that could
harm human health.
Problems with MCLG
Assumption #4:Fluoride has NO effect on ANY soft tissues
(at less than 50 ppm in water).
Problems with MCLG
•20 mg/day considered the “lowest observable adverse effect level” for crippling fluorosis.
•A safety factor of 2.5 used, resulting in a safe dose of 8 mg/day.
•Assuming people drink 2 liters of water a day & assuming no other sources of fluoride, EPA set the MCLG at 4 mg/L (8 mg/day / 2 liters = 4 mg/L).
Basis of MCLG
Converting MCLG into a “Reference Dose”
EPA Pesticide Division has traditionally derived its “reference dose” from the MCLG as follows:
•“Safe” dose = 8 mg/day (2 liters of 4 ppm)•The average adult weighs 70 kilograms (kg)•8 mg divided by 70 kg = 0.114 mg/kg
Reference Dose =
0.114 mg/kg/day (milligrams per kilogram of bodyweight per day)
Did EPA:“consider the need for an additional safety factor
of up to ten-fold to account for uncertainty in the data base relative to children”?
FQPA Requirement
Reasons why Additional Safety Factor for Children would be Appropriate
•Exposure during childhood causes severe dental fluorosis.
•Children’s bones are probably more, not less, susceptible to fluoride damage (Surgeon General 1983).
• New research (published after MCLG was adopted) hasraised additional health concerns from childhood exposure:
•Neurotoxicity (Xiang 2003)•Osteosarcoma (Bassin 2006)•Kidney damage (Xiong 2006)•Endocrine effects (Lin Fa-Fu 1991)
So, what happened?
DOW Agrosciences (2002):
“These levels of dietary exposure in combination with the potential dietary exposures that the proposed uses of ProFume would represent are considerably lower than the USEPA MCLG for fluoride of 0.114 mg/kg/bwt/day."
http://www.fluoridealert.org/pesticides/sulfuryl.f.fr.Feb.15.2002.htm
EPA (2002):
"In consideration of the proposed temporary tolerances for walnuts and raisins, the Agency used the maximum concentration limit goal (MCLG) of 4.0 ppm (0.114 mg/kg/day).”
http://www.fluoridealert.org/pesticides/sulfuryl.f.fr.Feb.7.2002.htm
Ooops….
Fluoride Exposure (mg/kg)Levy (2003)
Age (mo) 90th% 95th% Max
1.5 0.159 0.188 0.401
6 0.127 0.147 0.343
12 0.086 0.103 0.272
24 0.098 0.128 0.298
32 0.098 0.115 0.223
RED = Exceeds EPA’s reference dose (0.114 mg/kg)
Making a bad standard, worse
After it became apparent that some children arealready exceeding 0.114 mg/kg, EPA increased theallowable dosage for children.
Increasing the Safe Dosage
< 2003 January 2004 July 2005
Age Initial Safe Dosage
2nd Safe
Dosage
3rd Safe
Dosage
< 1 yr old 0.114 mg/kg 0.571 mg/kg 1.14 mg/kg
1-2 yrs old 0.114 mg/kg 0.308 mg/kg 0.615 mg/kg
3-5 yrs old 0.114 mg/kg 0.182 mg/kg 0.364 mg/kg
Making a bad standard, worse
The allowable dosage is now 10 times higher for infants than for adults
Problems with New “Safe Dosage”
•Not based on new data or research.
•Contradicts key component (SMCL) of EPA’s safe drinking water standard for fluoride.
•Dwarfs the dose that causes severe dental fluorosis.
•Exceeds the dosage (0.45 mg/kg/day) which increases bone fractures in less than 2 years in clinical trials with adult osteoporosis patients.
Did EPA:“consider children's… often unique exposure patterns”?
FQPA Requirement
EPA’s “Conservative” Estimate of Toothpaste Ingestion
"Despite the variability in the estimates of ingested toothpaste, maximum exposures to fluoride observed in those studies appear to converge to approximately
0.3 mg/day (assuming 2 brushings per day). The exposure estimates range from 0.004 to 0.04 mg/kg/day and should be considered conservative in nature..."
EPA, Health Risk Assessment, January 2004
Fluoride Ingestion from ToothpastePublished Data (2 brushings, 1000 ppm F)
Age (yrs) Avg Intake Max Intake Study
2 0.66 mg/day n/a Naccahe ‘87
2.5 0.54 mg/day 1.66 mg/day Bentley ‘99
2 - 3 0.56 mg/day n/a Simard ‘84
2 - 4 0.6 mg/day >1.46 mg/d Barnhart ‘76
3 - 6 0.76 mg/day 2.3 mg/day Hargreaves ‘75
3 0.36 mg/day n/a Naccahe ‘85
4 0.78 mg/day n/a Simard ‘84
4 0.26 mg/day 0.6 mg/day Ericsson ‘74
5 0.44 mg/day n/a Simard ‘84
Red: Exceeds EPA’s “Conservative Estimate” (0.3 mg/day)
Other Problems with
EPA’s Risk Assessment
Other Problems with EPA’sRisk Assessment
•Under-estimated fluoride exposure among adults by failing to account for high-end water consumers.
•Did a superficial analysis of acute fluoride toxicity by only considering the dose that kills, vs the dose that causes symptoms (nausea, vomiting, etc)
•Violated procedural requirements in a manner that restricted input and participation from concerned parties.
•And more: See FAN’s petition to EPA for further details
Implications of NRC Report
Implications of NRC Report
•The increases in allowable childhood dosages will need to be rescinded.
•A lower MCLG will necessitate a lower reference dose acrossthe board (both children and adults).
•Since many Americans are already exceeding current reference dose, many more will exceed the new, lower one.
Q & A
The Reference Dose
EPA (2002):
“EPA has determined that the dose to be used for risk assessment for exposure to fluoride is 0.114 mg F/kg/day, per the 1996 Cryolite RED. This value is used for all population subgroups ..."
http://www.epa.gov/fedrgstr/EPA-PEST/2002/April/Day-24/p9655.htm