OPP CORRESPONDENCE ASSIGNMENT FORM 

A41 incoming correspondence addressed to the Office Of the Director 

is assigned to FEAD for controlling and tracking, unless otherwise noted . 

10: Karlene Thomas, FEAD 

Please Assign To: BEAD RD SRR 

Advance Courtesy Copy 1o : `~ Jim Jones 

f-/An/ne Lindsay 

M y Monell 

l 

Date: " _.L! _(0 /~ 7-- 

HED BPPD iTRMD EFED AD 

Due Date : -LZI O Working Days __- No Response Necessary (FYI) Only 

Prepare for Appropriate Action 

Signature by- J Jim Jones 

Anne Lindsay 

- Determined by FEAD 
North Carolina Department of Health and Human Services 

Division of Public Health 

1931 Mail Service Center " Raleigh, North Carolina 27699-1931 

Michael F. Easley, Governor Leah Devlin, DDS, TMPH 

Carmen Hooker Odom, Secretary State Health Director 

Mr. Jim J. Jones, Director 

Office of Pesticide Programs PY1 S 12622 

USEPA 

1200 Pennsylvania Ave. NW 

Washington, DC 20460 

Dear Mr. Jones: 

February 2, 2007 

RECEIVED 

FEB 1 5 2007 

You may be aware that we recently completed an investigation, per the request of the North Carolina Department 

of Agriculture and Consumer Services (NCDACS), evaluating an instance in 2004 where three migrant farm 

women who worked on the same grape tomato farms in both Florida and North Carolina each delivered babies 

with birth defects. The grower the women worked for was Ag-Mart. Our report is entitled "Assessment of 

Maternal Occupational Pesticide Exposures during Pregnancy and Three Children with Birth Defects: North 

Carolina 2004" and can be found on the website, www.epi .state .nc.us, (occupational injury and illness web page). 

I am contacting you on behalf of the North Carolina Division of Public Health, Department of Health and Human 

Services, Raleigh, North Carolina to share two concerns. The first pertains to the Worker Protection Standard and 

the work assignments and pesticide application records kept by growers. While the grower in our investigation 

was apparently meeting the current standard, both work and spray records utilized in our evaluation were not 

precise making the epidemiological investigation challenging . The second concern is the lack of human research 

in the area of pesticide exposure and birth defects . More research is needed to better assess the level of risk 

associated with work involving specific pesticides and birth outcomes. Our concerns are explained in detail 

below along with recommendations for improvement. 

(1) To evaluate exposure for the investigation, the Occupational and Environmental Epidemiology Branch 

(OEEB) collected and reviewed work and pesticide spray records for the three women involved in the 

incident. Records were provided to OEEB by NCDACS and Ag-Mart. Information on date, hours and 

location of work (field assignments) were correlated with pesticide application records for each date. 

We were informed in the course of our assessment by Ag-Mart executives that field locations were 

"approximations", derived from records of harvested tomato arrival dates at the packing facility in 

Florida and from known tomato plantings and harvests . A different communication from their human 

resources department stated that crew leaders made the field assignments . With this input it appeared to 

us that work records could not exclude or confirm the field location of a farm worker on any specific 

workday. In addition, both Ag-Mart and NCDACS shared with us that spray records documented 

"ranges" (e.g . 8:OOam - 5 :OOpm) of possible spray times, not actual spray times. Consequently, the 

approach the OEEB investigators took to calculate exposure was to use any of the fields listed as a work 

location on the date of work and the spray ranges documented for pesticide applications . Therefore, the 

North Carolina Public Health 

working for a healthier and safer North Carolina 

Everywhere Everyday Everybody 

Location: 5605 Six Forks Rd. " Raleigh, N. C 27609-3811 

An Equal Opportunity EVloyer 
Mr. Jim J. Jones 

February 2, 2007 

Page 2 

records could only support a conclusion that the exposure was possible and such exposure can be 

associated with the birth defects experienced by at least one of the case mothers in our investigation . 

According to NCDACS, current pesticide regulations do not require that farm worker field assignments 

be documented. Labor regulations do not address this either . Pesticide laws do require growers to 

document the date and time the pesticide is applied. We would like to recommend to the U.S . EPA 

that the requirements of current pesticide regulations be strengthened to require more specific 

documentation of workers' field locations, field entry times, and pesticide application times . 

(2) In regard to research, our study was limited to a case series due to the small number of subjects and lack 

of pesticide sampling data. Consequently, after concluding the investigation, it could not be determined 

with certainty whether maternal pesticide exposure caused birth defects in any of the case-infants . 

Findings from the investigation did, however, alert Public Health of the likelihood that agricultural 

workers may be unnecessarily exposed to pesticides, and more research needs to be done to determine 

whether farm workers, like those in our report, may be at risk for birth defects from exposure to 

pesticides. We have noted in our review of the literature and toxicological data that most associations 

between pesticide exposure and birth defects have been established by animal studies . While many 

human studies show that pesticide exposure may be linked to birth defects, studies suffer from flaws in 

epidemiological methods, especially as they relate to exposure assessment. Therefore, there is no good 

evidence in human studies linking pesticide exposure and the occurrence of birth defects . Please 

consider conducting more human epidemiological studies, such as a large prospective cohort study, to 

improve our understanding of this issue. 

We have many workers in North Carolina who participate in farming activities and we are concerned 

that their health should be protected. We would appreciate your careful review of the concerns shared. If we 

can be of assistance in this matter, please let us know. 

Thank you for your consideration and please contact me with any questions that you may have at 

(919) 707-5024 . 

Sincerely, 

A_e-~~ 

J. Steven Cline, DDS, MPH 

Deputy State Health Director 

cc: Kevin Keaney 

Dr. Leah Devlin 

Dr. Doug Campbell