Fluoride Exposure from Pesticides:

1
Fluoride Exposure from Pesticides The Case
Against SULFURYL FLUORIDE
Michael Connett, FAN2nd Citizens Conference on
Fluoride July 30, 2006
2
Which Foods Can be Fumigated with Sulfuryl
Fluoride?
3
Dried Eggs
900 ppm
4
Wheat (flour germ)
130 ppm
5
Oat (flour rolled)
75 ppm
6
Legumes (57 types)
70 ppm
7
Processed Foods (ALL)
70 ppm
8
Barley (bran, flour, pearled)
45 ppm
9
Corn (meal flour)
30 - 35 ppm
10
Other Tolerances
Allowable levels of fluoride in or on food
70 ppm Herbs Spices (135 types) 40 ppm Wheat
(bran grain) 40 ppm Millet (grain) 45 ppm
Rice (flour) 40 ppm Coconut 40 ppm Cattle
(meat, dried) 31 ppm Rice (bran) 25 ppm Rice
(wild grain polished) 25 ppm Oat (grain)
11
Other Tolerances (cont.)
Allowable levels of fluoride in or on food
20 ppm Cocoa bean 15 ppm Peanuts 15 ppm
Coffee 15 ppm Barley (grain) 10 ppm Corn
(grain) 10 ppm Tree Nuts (14 types) 7 ppm
Raisin 5 ppm Cheese 5 ppm Powdered Milk 3 ppm
Dried Fruit
12
How Much Fluoride Will We Ingest From Fumigated
Foods?
13
The Daily Dose for adults

• 0.67 mg/day
• EPAs estimate for the average
• exposure to fluoride from SF
• 2nd Largest Daily Source of
• Fluoride (EPA 2006)

14
The Daily Dose for children

• 0.08 - 0.57 mg/day
• EPAs estimate for a childs average
• exposure to fluoride from SF
• 2nd Largest Daily Source of
• Fluoride (EPA 2006)

15
The Daily Dose for children
EPA, Final Health Risk Assessment, January 2006
16
How Did this Happen? EPAs Risk Assessment
17
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

18
Did EPA explicitly determine that the
tolerance is safe for children? FQPA Requirement
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An Adult-Based Health Standard (MCLG)

• For its risk assessment, EPA used the MCLG
  (Maximum
• Contaminant Level Goal)
• Set by EPAs Office of Water in 1985.
• Vigorously criticized by Natural Resources
  Defense Council
• (NRDC) and EPA Headquarters Union.

20
A glimpse into the history

• 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 Generals Panel on the Non-Dental Effects
  of
• Fluoride (1983)

21
Problems with MCLG
Assumption 1 Severe Dental Fluorosis is not an
adverse health effect
22
Problems with MCLG
Assumption 2 Crippling Skeletal Fluorosis is
the ONLY adverse effect fluoride has on bone.
23
Problems with MCLG
Assumption 3 20 mg/day is the lowest dose that
could harm human health.
24
Problems with MCLG
Assumption 4 Fluoride has NO effect on ANY soft
tissues (at less than 50 ppm in water).
25
Basis of 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).

26
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)

27
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
28
Reasons why Additional Safety Factor for
Children would be Appropriate

• Exposure during childhood causes severe dental
  fluorosis.
• Childrens bones are probably more, not less,
  susceptible
• to fluoride damage (Surgeon General 1983).
• New research (published after MCLG was adopted)
  has
• raised additional health concerns from childhood
  exposure
• Neurotoxicity (Xiang 2003)
• Osteosarcoma (Bassin 2006)
• Kidney damage (Xiong 2006)
• Endocrine effects (Lin Fa-Fu 1991)

29
So, what happened?
30
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/pest
icides/sulfuryl.f.fr.Feb.15.2002.htm
31
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
32
Ooops.
RED Exceeds EPAs reference dose (0.114 mg/kg)
33
Making a bad standard, worse
After it became apparent that some children
are already exceeding 0.114 mg/kg, EPA increased
the allowable dosage for children.
34
Increasing the Safe Dosage
35
Making a bad standard, worse
The allowable dosage is now 10 times higher for
infants than for adults
36
Problems with New Safe Dosage

• Not based on new data or research.
• Contradicts key component (SMCL) of EPAs 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.

37
Did EPA consider children's often unique
exposure patterns? FQPA Requirement
38
EPAs 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
39
Red Exceeds EPAs Conservative Estimate (0.3
mg/day)
40
Other Problems with EPAs Risk Assessment
41
Other Problems with EPAs Risk 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 FANs petition to EPA for further
  details

42
Implications of NRC Report
43
Implications of NRC Report

• The increases in allowable childhood dosages will
  need to
• be rescinded.
• A lower MCLG will necessitate a lower reference
  dose across
• the board (both children and adults).
• Since many Americans are already exceeding
  current
• reference dose, many more will exceed the new,
  lower one.

44
Q A
45
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/f
edrgstr/EPA-PEST/2002/April/Day-24/p9655.htm