Review of "Summary of Symptom Reports in Areas of Ae rial Pheromone Application for Management of Light Brown Apple Moth in Monterey and Santa Cruz C ounties September, October, and November 2007," by OEHHA, CADPR, and CDPH, dated 10 April 2008

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM

SUBJECT : Review of a Report by the California Office of Environmental Health Hazard Assessment (OEHHA), California Departme nt of Pesticide Regulation (CADPR), and California Department of Public Health (CDPH) Regarding Human Health Symptom Reports Following Aerial Applications of a Pheromone Formulation Used to Control Light Brown Apple Moth (LBAM).

FROM : Russell S. Jones, Ph.D., Senior Biologist /s/ 06/13/2008

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P)

THROUGH: Linda Hollis, Chief

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P)

TO : Janet Andersen, Ph.D., Director Biopesticides & Pollution Prevention Division (7511P)

OVERVIEW

The California Office of Environmental Health Hazard Assessment (OEHHA), in collaboration with the California Department of Pesticide Regulation (CADPR) and the California Department of Public Health (CADPH), compiled a report (dated 04/10/2008)summarizing human health symptom reports that occurred in and near areas where aeriallyapplied pheromones were applied to control Light Brown Apple Moth (LBAM) in California.

The Light Brown Apple Moth ( Epiphyas postvittana ) is a pest native to Australia and is

considered an exotic invasive insect in No rth America. According to USDA/APHIS, over 200 plant species may serve a potential hosts for LBAM, including a large number of hardwood and fruit and nut orchard trees, agricultural and horticultural crops, and ornamentals (see USDA APHIS Federal Quar antine Exemption Requests #07DA04). ItsReview of "Summary of Symptom Reports in Areas of Ae rial Pheromone Application for Management of Light Brown Apple Moth in Monterey and Santa Cruz C ounties September, October, and November 2007," by OEHHA, CADPR, and CDPH, dated 10 April 2008

2 presence in California was confirmed in March 2007 and as of March 2008, ongoing surveys with monitoring traps have captured over 18,000 LBAM moths. The captures have occurred predominantly in the southern Santa Cruz and northern Monterey counties, and in portions

of northwest Alameda, western Contra Costa, and northern San Francisco counties. Single trap captures indicate small populations may occur in seven additional counties.

In response to this infestation, USDA and the California Department of Food and Agriculture (CDFA), proposed to eradicate LBAM in Monter ey and Santa Cruz counties using non-toxic, mating disruption pheromones. The products selected by CDFA were Checkmate OLR-F® and Checkmate LBAM-F®. The active ingredients in both products are straight-chainlepidopteran pheromones (SCLPs) which are practically non-toxic to humans and other nontarget organisms. The SCLP pheromones have no toxic effects on the target pest LBAM nor on any other insect species.

However, due to the intention to apply these products over non-agricultural, residential areas, there were some public concerns regarding the potential health effects of the inert ingredients used to encapsulate the pheromones. These same inert ingredients have been used in similar SCLP products aerially-applied on agricultural sites without any reports of adverse effects

for at least a decade.

Assessment of Potential Toxicity of the Pheromone Products by CADPR and OEHHA

. The CADPR and OEHHA concluded in a report dated 31 October 2007, that "The toxicity data on the pheromones and on microencapsulated products suggest the possibility that exposure to a sufficient amount of airborne Checkmate microcapsule particles could result in some level of eye, skin, or respiratory irritation. However, as the product is diluted and applied over a large area, the degree of exposure as well as the potential for irritation should decrease significantly."

The CADPR further estimated that approximately 3 fluid oz of the formulated product per acre would be applied within the proposed treatment areas. Since the product itself is approximately 72% water, less than 1 fluid oz. of pheromones and encapsulating inerts would be applied per acre. The report further stated, "Because the application rate was extremely low, it is likely that exposure occurred at levels below those that would be expected to result in health effects." There were no toxicity concerns for the SCLP active ingredients.

Reports of Human Health Effects Following Aerial Applications of Checkmate

Pheromone Products. Following the aerial applications of the Checkmate products for LBAM control, reports of human health effect s were received from diverse sources including physicians, a CDFA call center, and numerous websites. A total of 643 symptom reports were received. Of those reports, 463 were deemed reviewable after eliminating duplicate reports and reports that did not involve symptoms in humans. The majority of the 463Review of "Summary of Symptom Reports in Areas of Ae rial Pheromone Application for Management of Light Brown Apple Moth in Monterey and Santa Cruz C ounties September, October, and November 2007," by OEHHA, CADPR, and CDPH, dated 10 April 2008

3 reports were from Monterey County (57%) a nd Santa Cruz County (36%). Respiratory symptoms predominated and included cough, shortness of breath, runny nose, upper respiratory irritation or pain, and wheezing. A few reports were of asthma or asthma

exacerbation, reactive airway disease, as well as headaches and diarrhea. Of the 463 symptom reports, only 74 (16%) were from individuals who s ought medical treatment from a physician, and only 44 (<10%) contained additional corroborating evidence (see Links discussion below).

NOTE: On 1 April 2008, 24 additional health symptom reports were received and evaluated by OEHHA/CADPR/CDPH, but these new reports did not alter any of the previous conclusions or statistical analyses.

Links Between Aerial Spraying of LBAM Ph eromone Products and Reported Human Health Symptoms. OEHHA/CADPR/CDPH investigators were unable to determine whether there was any causal link between aerial pheromone product spraying and the reported human health symptoms. Greater than 90% of the symptom reports did not contain adequate information to determine whether there was link between reported symptoms and Checkmate applications. Less than 25% of the reports included date and location of exposure information.

The remaining symptom reports (44 individuals; <10%) were physician incident reports (PIRs). These reports provided additional corroborating information (e.g. date of onset of illness, date of exposure, location where exposure occurred, description of exposure circumstances, individual's activity during exposure, etc.). However, even with this additional information, OEHHA/CADPR/CDPH investigators were still unable to determine any link between the symptom reports and pheromone product applications.

According to OEHHA/CADPR/CDPH, "Given the range of causes of these symptoms and the large number of individuals expected to experience such symptoms at any given time, the symptoms in the 463 reports make it difficult to clearly attribute these symptoms to any specific cause."

OEHHA/CADPR/CDPH further noted that no medical tests are available to confirm that the reported human health symptoms resulted from exposure to the pheromone products, and that any likely human exposure to the aerially-applied pheromone products would have been extremely low (i.e. <1 fluid oz. of encapsulated pheromone per acre), based on CADPR calculations and monitoring data obtained during aerial applications. The per acre application rate is far below any level that might be potentially harmful to human health.Review of "Summary of Symptom Reports in Areas of Ae rial Pheromone Application for Management of Light Brown Apple Moth in Monterey and Santa Cruz C ounties September, October, and November 2007," by OEHHA, CADPR, and CDPH, dated 10 April 2008

4 OEHHA/CADPR/CDPH CONCLUSIONS

None of the 463 symptom reports contained sufficient information to determine a causal link between aerial application of the pheromone products and any human health symptom reports. Less than 25% provided any date and location of exposure information, and <10% provided information regarding date of onset of illness, date of exposure, location where exposure occurred, description of exposure circumstances, and individual's activity during

exposure.

Even in those reports containing more or less "complete" corroborating evidence (<10%), it was still not possible to correlate these symptoms with aerial pheromone product applications

due to:

1. Lack of any medical tests to confirm whether the reported symptoms resulted directly from exposure to the aerially-applied pheromone product;

2. Incomplete and/or inadequate information regarding pre-existing health conditions amongst the reportees;

3. The extremely low potential for exposure to pheromone products based on estimates made by CADPR and by monitoring data obtained during the time the pheromone products were applied; and

4. The reported symptom rates were low, involve symptoms that were relatively mild, were non-specific in nature, and the reported symptoms are quite common in the unexposed general population (based on surveys by CDPH).

OEHHA/CADPR/CDPH RECOMMENDATIONS

In order to improve the quality of health report information collection related to future aerial applications of LBAM pheromone products, OEHHA/CADPR/CDPH are currently designing a program that will encourage a single point of contact for health symptom reports, as well as visits to physicians if it is suspected that illness has resulted from exposure to LBAM control b products. Furthermore, physicians will be offered training on how to recognize and report known or suspected pesticide-related illness.

In conjunction with the aerial LBAM pheromone product applications proposed for Monterey and Santa Cruz Counties in 2008, OEHHA/CADPR/CDPH are preparing to implement the following recommendations:Review of "Summary of Symptom Reports in Areas of Ae rial Pheromone Application for Management of Light Brown Apple Moth in Monterey and Santa Cruz C ounties September, October, and November 2007," by OEHHA, CADPR, and CDPH, dated 10 April 2008

5 1. "Provide clear communications to local government officials and the public on the importance and effectiveness of the eradication efforts, available information on any potential health risks associated with the pheromone formulation to be used, and steps that individuals can take to minimize their potential exposure to the formulation."

2. "Provide information and recommendations for people who are worried about their respiratory health or consider themselves chemically sensitive, and who may want to make a special effort to avoid exposure to the formulation."

3. "Coordinate effectively with local health agencies, other sate agencies and elected officials on collecting illness reports."

4. "Establish a centralized system for collecting and analyzing citizen symptom and illness reports, and establish an effective data-sharing system among health and regulatory agencies."

5. "Communicate effectively with community health care providers on recognition of pesticide-related illness and symptoms and the requirements for reporting pesticide

illness."

BPPD CONCLUSIONS

1. Based on low toxicity in animal testing, and expected low exposure to humans, no risk to human health is expected from the use of products containing straight-chain lepidopteran pheromones (SCLPs), such as the LBAM pheromones.

2. During more than 10 years of use of SCLPs as pesticides, no adverse effects have been reported. The safety record for SCLPs has allowed the Agency to conclude that consumption of food containing residues of these pheromones presents no risk.

3. The Checkmate LBAM control products applied under the conditions of the Section 18 were formulated with inert ingredients that are cleared by EPA for use on food commodities. It is highly unlikely that exposure to these ingredients would result in any of the human health symptoms reported in California.

4. The application rate of the Checkmate LBAM control products is so low that <1 fluid oz of encapsulated pheromone is applied per acre. This rate is orders of magnitude below any potential threshold for human health symptoms, such as eye, skin, or respiratory

irritation effects.

5. Adverse effects on non target organisms (mammals, birds, and aquatic organisms) are notReview of "Summary of Symptom Reports in Areas of Ae rial Pheromone Application for Management of Light Brown Apple Moth in Monterey and Santa Cruz C ounties September, October, and November 2007," by OEHHA, CADPR, and CDPH, dated 10 April 2008

6 expected because the LBAM pheromones are released in very small amounts to the environment and act on a select group of in sects (the Light Brown Apple Moth, or LBAM).

6. BPPD agrees with the conclusions made in the OEHHA/CADPR/CDPH report, dated 04/10/2008. Furthermore, BPPD concurs with the recommendations made in the report and supports the timely implementation of these recommendations. Centralized data reporting, uniformity in data collection methods , training of the data collectors, improved risk communication to the public, and transparency can only serve to improve the quality of the information collected and demonstrate that SCLP products are safe to use in LBAM integrated control programs in California.

cc: R. S. Jones, J. Andersen, L. Hollis, S. Morill, BPPD Subject File/IHAD, BPB File

R. S. Jones, FT, OPY: 06/13/2008