COUNTY OF SANTA CRUZ
CALIFORNIA DEPARTMENT OF FOOD
AND AGRICULTURE; A.G. KAWAMURA, in
his official capacity as Secretary of the
California Department of Food and Agriculture;
and DOES 1 through 100, inclusive,
Case No. 158516 DECLARATION OF RICHARD PHILP IN SUPPORT OF EX PARTE APPLICATION FOR TEMPORARY RESTRAINING ORDER Date: October 31, 2007 Time: 1:00 p.m. Dept: 8 I, Richard Philp, hereby declare:
1. 1 am an Emeritus Professor of Pharmacology and Toxicology with the University of Western Ontario in London, Canada. I have a Ph.D. in Pharmacology from the University of Western Ontario and have spent my career as a professor of Pharmacology and Toxicology. 1 have published over 90 peer-reviewed manuscripts in the area of pharmacology and toxicology and I am an experienced researcher on pharmacology and toxicology issues. A copy of my curriculum vitae is attached hereto as Exhibit A. I have personal knowledge of the facts set forth below, and if called upon to testify thereto 1 could and would do so competently.
2. After Monterey County was aerially sprayed with the pesticide Checkmate OLR-F in September 2007,1 was asked to review the health hazards associated with this aerial spraying. In conducting my review, I reviewed available literature and government documents concerning Checkmate and I drafted a preliminary report on this issue, a true and correct copy of which is attached hereto as Exhibit B. My general conclusions and recommendations are set forth at page 8 of my final report.
3. In sum, I have concluded that no chronic toxicity study of Checkmate has been conducted in a mammalian species by any route of administration and certainly not involving exposures to the product to be employed by the intended method of application (aerosol spray of microcapsules). Any claims of the safety of Checkmate are based on extrapolation from acute toxicity studies and one sub-acute, 90-day study that employed the oral route of administration of certain chemicals related, but not identical, to those used in Checkmate. One cannot conclude from these studies that Checkmate is a safe product to aerial spray over an urban population, nor can one guarantee that longer-term, repeated exposures of humans are without risk. A chronic toxicity study of at least 90 days and preferably six months duration, employing daily exposure to aerosol of Checkmate at a high exposure level would be required before a conclusion of safety could be legitimately drawn. It is customary in such studies to use a much higher exposure level in order not to miss adverse reactions that might occur too infrequently to be detected at lower exposures.
4. In none of the documents I reviewed, including the USDA environmental assessment, is there any mention of previous experience with aerial spraying of populated, urban areas. Previous efforts to control LBAM in the proposed treatment area employed ground application techniques. Pheromone baited traps were placed throughout the State of California to monitor the moth population and distribution. Isolated populations in Napa and Oakley were treated using ground equipment with Bacillus thuringiensis kurstaki (Btk) (USDA Environmental Assessment, 2007, p2, para 2). This is a bacterial product that attacks the early larval stages of most lepidopterans.
5. There is ample evidence that many pheromones and semiochemicals (the synthetic counterparts of pheromones) possess significant toxicity for aquatic species. This suggests that aerial spraying carries an increased environmental risk given the difficulty in confining the spray to the target area.
6. In summary, and as more fully explained in my attached report, the USDA and EPA documents I reviewed are filled with contradictory statements regarding the toxicity testing of pheromones, inappropriate extrapolations from irrelevant toxicity studies, and are suggestive of a poor understanding of basic pharmacological and toxicological principles.
7. In my opinion, since the decision to use aerial spraying as the method of application appears to have been made entirely on economic grounds, the decision should be revisited given the lack of adequate evidence for its safety in the long term. Either ground-based methods of application should be employed or an adequate chronic toxicity study should be conducted. Groundbased technology has the added advantage of posing less risk to the environment.
8. Finally, I have recently reviewed the toxicology of the "inert" ingredients provided to me and found that: i) some have been shown to be skin irritants in animal studies; ii) no information regarding respiratory toxicity or absorption is generally available; iii) no carcinogenicity studies have been performed on some; and iv) I was unable to find inhalation toxicity studies for any of the inert ingredients. This further supports my conclusion that this product should not be aerially sprayed as intended at this time. 1 declare under penalty of perjury under the laws of the State of California the foregoing is true and correct and that this Declaration was executed on this 29th day of October 2007 at London, Canada.