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