FAN Index to
US EPA CHEERS study in Duval County, Florida

 
 

The Children's Environmental Exposure Research Study (CHEERS)

See Table below: Fluorinated pesticides selected to be monitored in CHEERS study.
See also: Documents and media reports relating to the CHEERS study in Duval County, Florida.

The plans to conduct this highly controversial 2-year study were formally ended on April 8, 2005.

Update from Public Employees for Environmental Responsibility (PEER):

EPA Embraces Human Testing Without Safeguards
Infamous CHEERS Study Returns and Multiplies Under Different Names

On Friday, April 8, in the midst of Senate hearings on his nomination to head the U.S. Environmental Protection Agency, Stephen Johnson issued a defensively worded statement announcing the cancellation of the CHEERS study in which parents would be paid to spray pesticides in the rooms occupied by their infant children under age 3. Johnson did not admit any ethical problems with the study but nonetheless concluded the study could not go forward due to an atmosphere “of gross misrepresentation and controversy.”

In fact, Johnson is expanding the use of human pesticide dosing studies by EPA. While CHEERS will not proceed with EPA funding, the same study can take place with private sponsors. In fact, the American Chemistry Council, representing 135 companies including pesticide makers, already pledged $2 million toward the study’s $9 million overall cost.

The reason Stephen Johnson clung so stubbornly to CHEERS is that it serves as a model for industry on how to conduct similar experiments for submissions to EPA. The pesticide industry has been pressing the Bush Administration to liberalize rules on human testing of pesticides and other chemicals since the 1996 Food Quality Protection Act. That Act set ten-fold stricter exposure standards for children absent reliable data showing no harm. Industry needs actual human experimental data to trump animal studies in order to justify relaxed exposure limits.

In February, EPA published a draft policy that opens the door for accepting any experiments conducted by pesticide companies and chemical manufacturers using human subjects without establishing any safeguards to ensure that the studies are conducted ethically and without harm to the subjects... - Read more

This study generated an enormous amount of controversy. The Public Employees for Environmental Responsibility (PEER) and the Environmental Working Group (EWG) took the lead on exposing the issue. EWG called the study unethical and scientifically questionable.

PEER agreed. In a November 1, 2004, press release they stated

... the study will monitor developmental changes in babies, from birth to age 3, who are exposed to pesticides in their homes. Set in Jacksonville, Florida (Duval County), the study looks at 60 infants and toddlers. Agency scientists not connected with the study are expressing concerns about –

• Financial Incentives. The study makes payments to families totaling $970 for participating throughout the entire two-year period. Families who complete the study also get to keep the camcorder they are provided to record their babies’ behavior. In addition, families are given bibs, t-shirts and other promotional items. Families are recruited from public clinics and hospitals;

• Lack of Treatment. The study makes no provision for intervening if infants or toddlers show signs of developmental problems or register alarmingly high exposure levels in their urine samples. Instead, families continue in the study so long as researchers are notified when each pesticide application occurs; and

• Lack of Education. Unlike other EPA programs in this area, the study does not provide participants information about the safe or proper ways to apply or store pesticides around the home. Nor does the study furnish participating families with information about the risks of prolonged or excessive exposure to pesticides ...

The first public notice on the CHEERS-Duval County study was published October 3, 2003, in the Federal Register. This Notice stated that the co-principal investigators were Nicolle S. Tulve and Roy Fortmann both with the EPA's National Exposure Research Laboratory in Research Triangle Park, NC.

In a document attached to the second Notice of the CHEERS study published in the March 3, 2004 Federal Register, a short abstract of the study was presented:

Characterization of the CHEERS study in Jacksonville, Duval County, Florida :

The US EPA's Office of Research and Development's National Exposure Research Laboratory (ORD/NERL) proposes to conduct a two-year longitudinal field measurement study of young children's (aged 0 to 3 years) potential exposures to current-use pesticides and selected phthalates, polybrominated diphenyl ethes, and perfluorinated compounds that may be found in residential environments. The study will be conducted in Duval County, Jacksonville, Florida over a two-year period from 2004-2006. Sixty young children will be recruited into this study in two cohorts: (1) infants recruited into the study soon after birth, and , (2) children recruited into the study at approximately 12 months of age. The study involves up to six data collection events at each home during the two-year study period. During each event, environmental and biological samples will be collected to measure chemical concentrations and questionnaires will be administered to collect data that will be used to estimate aggregate exposures and to analyze the measurement data. Aggregate exposures will be estimated for the current-use pesticides and selected phthalates in the study. The data collected on the polybrominated diphenyl ethers and the perfluorinated compounds will be used to evaluate the potential magnitude for exposure and to determine the temporal and spatial variability of these chemicals in residences. The study will collect data to fill critical gaps in our understanding of very young children's exposure to chemicals in their residences. The study will help the Agency reduce uncertainty in exposure and risk assessments for children by providing data on exposure factors and validated tools for estimating children's expsure to contaminants, as well as providing much needed measurement data for model refinement. The exposure factors generated in this study will be included in the National Center for Environmental Assessment's (NCEA) Child Specific Exposure Factors Handbook. Additionally, the information will apear in the form of final EPA reports, journal articles, and will also be made publicly available in an electronic database for use by the scientific community, risk assessors, and risk managers.
Ref: Part A: Supporting Statement for Information Collection Request 2126.01 -

Docket No. ORD-2003-0011-0006 attached to the March 3, 2004, Federal Register.

Of interest to FAN's Pesticide Project are the chemicals identified for monitoring in this study. They are:
•• 4 of 16 pesticides are the fluorinated
Bifenthrin, Fipronil, lambda-Cyhalothrin, and Cyfluthrin I, II, III, IV, total;
•• one breakdown product of Cyfluthrin -4-fluoro-3-phenoxybenzoic acid- (CAS No. 77279-89-1) will be analyzed in biological media. It's molecular structure is

[Note: the CDC's "Third National Report on Human Exposure to Environmental Chemicals," expected to be released sometime in 2005, includes 4-fluoro-3-phenoxybenzoic acid in its list of chemicals.]

•• and the perfluorinated chemicals PFOA (Perfluorooctanoic acid) and PFOS (Perfluorooctane sulfonate).

Note: PFOA and PFOS chemicals were used as "Inerts" in pesticides up until 2000. Since 2000, EPA removed most of these chemicals from the
"Inert" lists, but there are still some, such as Sulfluramid (used in ant baits) which EPA has approved for use up until the year 2016.)

The PFOA derivative of greatest concern and most wide spread use is the ammonium salt (commonly known as C8, C-8, or APFO) -
CAS No: 3825-26-1. The molecular structure is:

For more information see:

Environmental Working Group series on Pesticide Testing on Humans at http://www.ewg.org/
Public Employees for Environmental Responsibility (PEER) at http://www.peer.org/
US EPA's CHEERS website at http://www.epa.gov/cheers/basic.htm or http://www.epa.gov/cheers/

Fluorinated pesticides selected to be monitored in CHEERS study.
Pesticide Activity Adverse Effects Environmental Effects Approved for use on food in the US CAS No.

Code of Federal Regulation
Bifenthrin Insecticide, Acaricide (pyrethroid)   See effects
Ataxia
Bladder
Body Weight Decrease
Cancer: Possible Human Carcinogen: URINARY BLADDER
Endocrine: Ovary/Estrus
Endocrine: Suspected Disruptor
Endocrine: Thyroid
Liver
Lung
Tremors/Convulsions

See effects

Very Highly Toxic to Fish and Zooplankton

Yes

As of September 25, 2003: US EPA Maximum residue tolerance levels in or on 116 food commodities.

See tolerances

2657-04-3 (Cis)

83322-02-5 (Trans)

CFR 180.442

Fipronil

Acaracide, Insecticide (Pyrazole),

Wood Preservative (to control termites)

See effects
Body Weight Decrease
Bone
Brain
Cancer: Possible Human Carcinogen - THYROID
Cholesterol
Clastogenicity
CNS
Dermal
Endocrine: Altered Sex Ratio
Endocrine: Pituitary - (disruption in the thyroid-pituitary status)
Endocrine: Suspected Disruptor
Endocrine: Testicular
Endocrine: Thyroid
Kidney
Liver
Reproductive

See effects
-- Highly toxic to rainbow trout and very highly toxic to bluegill sunfish
-- The sulfone metabolite is 6.3 times more toxic to rainbow trout and 3.3 times more toxic than the parent compound to bluegill sunfish.
-- High toxicity to freshwater aquatic invertebrates. The sulfone metabolite is 6.6 times more toxic and the desulfinyl photodegradate 1.9 times more toxic on an acute basis to freshwater invertebrates than the parent compound.
-- Highly toxic to upland game birds.. The sulfone metabolite is more toxic than the parent compound to certain bird species. This metabolite has shown a very high toxicity toward upland game birds ...
-- Highly toxic to bees, lizards, and gallinaceous birds

Contamination incident:
2001: Crawfish farmers in Louisiana file Class Action against the makers of the fipronil insecticide ICON, Rhone-Poulenc/Aventis, for killing crawfish.
2004: Farmers and landowners in Class Action awarded $45 million.

Yes

As of September 30, 2003, US EPA Maximum residue tolerance levels in or on 30 food commodities.

See tolerances

120068-37-3

CFR 180.517 

lambda-Cyhalothrin Insecticide
(Pyrethroid)
 See effects
Ataxia
Body Weight Decrease
Cholesterol
CNS
Endocrine: Breast
Endocrine: Suspected Disruptor
Endocrine: Thyroid
Eye
Liver
Salivary Glands
Tremors/Convulsions

See effects

Highly Toxic to Fish, Aquatic Invertebrates, and Honeybees

Yes

As of September 3, 2003, US EPA Maximum residue tolerance levels in or on 79 food commodities. (In 2002 there were 60 tolerances).

See tolerances

91465-08-6

CFR 180.438

Note on Cyfluthrin: We do not, at this time, have the information on the various species of Cyfluthrin (I, II, III, IV, total)
Cyfluthrin Insecticide
(Pyrethroid)
 See effects
Ataxia
Blood
Body Weight Decrease
Bone
Brain
Endocrine: Adrenal
Endocrine: Ovary
Endocrine: Thymus
Eye - Microphthalmia
Kidney
Lung
Salivary Glands
Sciatic nerve
Tremors

See effects

Acute Toxicity to Fish and Saltwater Life

Yes

As of January 24, 2004: US EPA Maximum residue tolerance levels in or on over 100 food commodities.

See tolerances. 

68359-37-5

CFR 180.436

Beta-cyfluthrin Insecticide
(Pyrethroid)

See effects
Body Weight Decrease
Bone
CNS
Eye
Lung

Beta-cyfluthrin has an approximately 2 to 5 times higher acute toxicity than cyfluthrin.

  See effects

-- Highly toxic to Fish, Aquatic Invertebrates.

-- High risk to Honey Bees and other Arthropod species.

Not available

According to Pesticide Action Network, this pesticide is used for:

-- Structural Pest Control
-- Landscape
-- Vertebrate Pest Control
-- Commodity Fumigation

68359-37-5

See also: Documents and media reports relating to the CHEERS study in Duval County, Florida.

 
Fluoride Action Network | Pesticide Project | 315-379-9200 | pesticides@fluoridealert.org