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: `~ JimJones f-/An/ne Lindsay M y Monell 

# l Date: "

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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 FEADNorth 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, DC20460 Dear Mr. Jones: February 2, 2007 

## RECEIVED FEB 1 5 2007

You may be aware that we recently completed an investigation, perthe request ofthe 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 canbe 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 ofPublic 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, bothwork 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 ofpesticide exposure and birth defects. More research is needed to better assess the level ofrisk 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 ofwork (field assignments) were correlated with pesticide application records for eachdate. We were informed in the course of our assessment by Ag-Mart executives that field locations were "approximations", derived fromrecords of harvested tomato arrival dates at the packing facility in Florida and from

known tomato plantings and harvests. Adifferent communication fromtheir 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 farmworker 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 tookto calculate exposure was to use any of the fields listed as a work location on the date ofworkand the spray ranges documented for pesticide applications. Therefore, the

North Carolina Public Health workingfor a healthierand saferNorthCarolina Everywhere Everyday Everybody Location: 5605Six Forks Rd. "Raleigh, N . C 27609-3811 An Equal Opportunity EVloyerMr . 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 birthdefects experienced by at least one of the case mothers in our investigation. According to NCDACS, current pesticide regulations do not require that farmworker field assignments be documented. Labor regulations do not address this either . Pesticide laws do require growers to document the date and time thepesticide 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, fieldentrytimes, 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 ofthe case-infants. Findings fromthe 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 farmworkers, like those in our report, may be at risk for birth defects from exposure to pesticides. We have noted in our review ofthe 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 fromflaws 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 ofbirth 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 reviewofthe concerns shared. If we can be of assistance in this matter, please let us know . Thankyou 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