Department of Pesticide Regulation Logo

Paul E. Helliker Director

Department of Pesticide Regulation


   
   
   
   
  California Notice 2001-5

California State Seal
Gray Davis
Governor

Winston H. Hickox
Secretary, California
Environmental
Protection Agency

SEMIANNUAL REPORT SUMMARIZING THE REEVALUATION STATUS
OF PESTICIDE PRODUCTS DURING THE PERIOD OF
January 1, 2001 THROUGH June 30, 2001


California regulations require the Department of Pesticide Regulation (DPR) to investigate all reports of actual or potential significant adverse effects to people or the environment resulting from the use of pesticides. If an adverse impact occurred or is likely to occur, the regulations require DPR to reevaluate the registration of the pesticide.

Title 3, California Code of Regulations (CCR), section 6221, specifies the factors under which DPR may initiate a reevaluation: (a) public or worker health hazard, (b) environmental contamination, (c) residue over tolerance, (d) fish or wildlife hazard, (e) lack of efficacy,
(f) undesirable phytotoxicity, (g) hazardous packaging, (h) inadequate labeling, (i) disruption of the implementation or conduct of pest management, (j) other information suggesting a significant adverse effect, and (k) availability of an effective and feasible alternative material or procedure that is demonstrably less destructive to the environment. Often, ongoing DPR reviews trigger a reevaluation. Reevaluation triggers also include state and county pesticide use surveillance and illness investigations, pesticide residue sample analyses, environmental monitoring activities, and information from other state or federal agencies.

When a pesticide enters the reevaluation process, DPR reviews existing data. DPR requires registrants to provide additional data to determine the nature or the extent of the potential hazard or identify appropriate mitigation measures, if needed.

DPR concludes reevaluations in a number of different ways. If the data demonstrate that use of the pesticide presents no significant adverse effects, DPR concludes the reevaluation without additional mitigation measures. If additional mitigation measures are necessary, DPR places appropriate restrictions upon the use of the pesticide to mitigate the potential adverse effect. If the adverse impact cannot be mitigated, DPR cancels or suspends the registration of the pesticide product.

This report complies with the requirements of CCR section 6225. CCR section 6225 requires DPR to prepare a semiannual report describing pesticides evaluated, under reevaluation, or for which factual or scientific information was received, but no reevaluation was initiated. The report contains two sections:

I. Formal Reevaluation - initiated when an investigation indicates a significant adverse impact has occurred or is likely to occur (page - 2); and
II. Preliminary Investigations (Evaluations) - products or active ingredients for which DPR receives possible adverse, factual, or scientific information, but no reevaluation has been initiated (page - 5).

I. FORMAL REEVALUATION

Undertaken when investigations indicate that a significant adverse impact has occurred or is likely to occur.

BRODIFACOUM - 33 Products

Brodifacoum is registered in California to control rats and mice in residential, industrial, commercial, agricultural, and public buildings. Registrants formulate the product with a grain-based bait in pellets, mini-pellets, and wax blocks.

On December 30, 1999, at the request of the Department of Fish and Game (DFG), DPR placed pesticide products containing brodifacoum into reevaluation. DFG expressed concern that California's wildlife are exposed and adversely affected by currently registered uses of the anticoagulant rodenticide brodifacoum.

Since 1994, DFG's Pesticide Investigations Unit has investigated 58 cases of possible wildlife exposure to anticoagulant rodenticides. Residues of anticoagulant rodenticides were detected in 38 birds and mammals, and residues of brodifacoum were identified in 31 birds and mammals, accounting for 82 percent of the anticoagulant exposures. Of those individuals in which residues of brodifacoum were detected, clinical signs of anticoagulant poisoning were observed in 10 to 20 percent. Eleven of the animals also carried residues of at least one other anticoagulant rodenticide in conjunction with brodifacoum. Because wildlife typically retreats to dens, burrows, or unobtrusive roosts in the final stages of anticoagulant poisoning, exposure of nontarget wildlife to this compound may be more extensive. Most of the birds and mammals exposed to brodifacoum were recovered from areas adjacent to urban development in Santa Clara, Los Angeles, Ventura, Orange, San Benito, Alameda, and Contra Costa counties.

In February 2001, DPR asked brodifacoum registrants to submit mitigation measures. In response to that request, registrants requested a meeting with DPR. DPR and DFG staff met with representatives of the Rodenticide Registrant Task Force in April 2001. At that meeting DPR agreed to review information submitted by the registrants and prepare a written response. DPR is drafting a response to the submitted data and information.


CYFLUTHRIN - 54 Products

The pesticide active ingredient cyfluthrin is a nonsystemic pyrethroid insecticide registered for use on numerous field, fruit, and vegetable crops, including citrus. In addition, DPR registers pesticide products containing cyfluthrin for use on lawns and ornamental plants, animals, and around industrial, institutional, agricultural, and household structures.

DPR initiated the reevaluation on May 8, 1998, based on its investigation of a May 1997 outbreak of respiratory irritation reported among orange harvesters exposed to residues of cyfluthrin in Tulare County and other pesticide illness reports related to cyfluthrin. As a part of the investigation of the Tulare County incident, DPR's Worker Health and Safety Branch conducted two separate inhalation-monitoring studies in orange groves during orange harvest. DPR determined that since dust and pollen are a part of the normal working environment, something different in the work environment led to the worker's respiratory irritation symptoms. DPR believes that the application of cyfluthrin to the citrus groves close to harvest led to the respiratory symptoms experienced. DPR compiled the results of its monitoring study in "Health and Safety Report, HS - 1765."

In mid-September 1998, the basic manufacturer of cyfluthrin submitted the results of several studies and journal articles concerning the respiratory irritation of cyfluthrin. On October 29, 1998, DPR met with the basic manufacturer to discuss the cyfluthrin reevaluation. At that meeting, DPR agreed to review the submitted studies and journal articles before deciding whether to require additional data.

DPR reviewed the results of three studies regarding respiratory irritation. In the mouse study, a NOEL of 5.4 mg/m3 was identified, which was based on the reduced respiratory rate noted at the 21.9 mg/m3 exposure level. In the rat study, at the lowest exposure level of 0.7 mg/m3, the respiratory rate was minimally reduced in comparison to the control animals. The author calculated a NOEL of 0.5 mg/m3. In the human study, human subjects were exposed under static conditions in which the initial exposure concentrations were reported to be 0.18 and 0.1 mg/m3 for the two exposure groups. Throat and nasal irritation was noted by 8 of the 10 subjects in both exposures. Due to several problems including the indeterminate concentration to which the subjects were exposed, a NOEL for sensory irritation could not be established. Since the rat is more sensitive than the mouse in regard to the irritating effects of cyfluthrin, the most appropriate NOEL appears to be the 0.5 mg/m3 derived from the rat study.

DPR reviewed all of the submitted information and data. Based on that review, DPR is requiring registrants to submit the following additional data: (1) a worker exposure study of hand harvesting sweet corn (due December 31, 2002); and (2) monitoring data for structural applications, including fogger applications (due December 31, 2002).



METHYL BROMIDE - 43 Products

Methyl bromide is a colorless odorless gas that has been widely used since the 1940s as a preplant soil-fumigant for controlling nematodes, plant pathogens, weeds, and insects. After harvest, it is used to protect crops from pest damage during storage and transportation. Methyl bromide is also use to eradicate wood-destroying pests in homes and other structures, and to control pests in mills, ships, railroad cars, and other transportation vehicles.

Since the early 1990s, DPR has focused considerable attention on ensuring the safe use of the fumigant methyl bromide. ARB monitored during the 2000 methyl bromide use season to measure ambient air concentrations and ascertain whether they posed a threat to public health. Data indicate that short-term levels of methyl bromide were well within acceptable limits. However, data also indicate that ambient air concentrations in a number of locations exceeded DPR's target exposure level for seasonal (six- to eight weeks) exposures. DPR has determined that in certain high-use areas, the use of methyl bromide may cause a significant adverse impact. On June 26, 2001, DPR placed all products containing methyl bromide and allowing field fumigation into reevaluation based on the results of the 2000 monitoring data.

In order to determine whether methyl bromide is not resulting in a significant adverse impact from seasonal exposures to methyl bromide, DPR is requiring the methyl bromide registrants listed in this notice to conduct ambient air quality monitoring in the following areas that have the highest, seasonal methyl bromide use in California: Camarillo/Oxnard area of Ventura County (monitor during July - September, 2001); Santa Maria area of Santa Barbara County (monitor during August - October, 2001); and south of Livingston in Merced County (monitor during February - April, 2002). Two weeks after completion of the sampling, the registrant must submit a status report of activities. Final reports of the air quality monitoring must be submitted for each of the three areas within four (4) months of completing the sampling.

PROPETAMPHOS (Safrotin) - 1 Product

DPR placed products containing propetamphos into reevaluation on March 22, 1990. Applicators use propetamphos indoors as an insecticide. DPR initiated the reevaluation based upon illnesses attributed to use of products containing propetamphos. In addition to the reports of illnesses, DPR was also concerned about the potential for overexposure of humans in contact with rooms treated with propetamphos.

In September 1990, DPR required the registrant to submit (1) a dermal sensitization study, (2) an odor threshold study, (3) an indoor exposure study, and (4) a dermal absorption study. The registrant submitted the dermal sensitization study in January 1991. Rather than conduct an odor threshold study, the registrant conducted a sensory irritation study. The registrant submitted the results of the sensory irritation study in June 1993. The results of an indoor exposure study were submitted in April 1994. Rather than conduct a dermal absorption study, the registrant requested DPR use an assumption of 100 percent dermal absorption.

In February 1998, DPR informed registrants that it was initiating the risk assessment process for pesticide products containing the active ingredient propetamphos. In July 1998, DPR issued a notice identifying the definitive toxicity and exposure studies, critical endpoints/no effect levels used in the propetamphos risk assessment. In November 1999, DPR completed its risk assessment of propetamphos. At the completion of the risk assessment, only one product containing propetamphos remained registered for use in California. Using current toxicity and exposure data, DPR determined that the calculated margins of safety for propetamphos are less than values conventionally considered to be protective of human health. In a notice dated December 27, 1999, DPR informed the registrant that it must institute mitigation measures to reduce exposure from: (1) broadcast applications,
(2) gallery (termite) applications, and (3) spot and crack-and-crevice applications made by structural operators. The registrant has agreed to amend their product label to reflect mitigation measures for each of these application types. Because U.S. EPA must approve any amendments to the label of a pesticide product before DPR can accept the amended label, the registrant requested that DPR wait until U.S. EPA completes its reregistration of propetamphos.

On May 7, 2001, the registrant submitted a U.S. EPA approved amended label to DPR. The amended label is under review.

II. PRELIMINARY INVESTIGATIONS (EVALUATIONS)

DPR conducts preliminary investigations on products for which DPR or other state or county agencies have identified possible hazards. As a result of evaluation, the investigations may lead to formal reevaluation.

BLUE CHIP GERMICIDAL CLEANER

Blue Chip Germicidal Cleaner is labeled for use in hospitals to clean hard surfaces such as floors, walls, woodwork, and equipment. In compliance with FAC section 12825.5, the registrant of Blue Chip Germicidal Cleaner submitted an adverse effect disclosure. The registrant submitted the results of an eye irritation and an inhalation study.

The data indicate that the product is Toxicity Category II for acute inhalation hazard and Toxicity Category I for eye irritation. The product label does not adequately identify either toxicity hazard. U.S. EPA must approve amendments to pesticide product labels before they can be accepted by DPR. The registrant submitted an amended label to U.S. EPA in 1999. In September 1999, U.S. EPA required the registrant to make numerous additional changes to this product label. In June 2000, U.S. EPA requested additional information from the registrant and in January 2001, U.S. EPA asked the registrant to require the use of a respirator. In response, the registrant agreed to conduct further respiratory inhalation studies. The results of a respiratory study will be submitted to U.S. EPA and DPR in July 2001.
U.S. EPA is expected to make a decision on the current amended product label in
October 2001.

MALATHION - 3 Products

In reviewing the acute toxicity database for products containing malathion, DPR's Medical Toxicology Branch determined that three malathion products might not bear an appropriate signal word and precautionary statement. Data on file with DPR at the time indicated that products containing 57 percent malathion are likely to be toxicity Category II for acute dermal toxicity and primary eye irritation. To resolve DPR's concerns, registrants needed to either provide new studies or amend the labels of their products. DPR informed the two registrants of our concerns regarding acute dermal toxicity and primary eye irritation. One of the registrants conducted and submitted new acute toxicity studies on their product as formulated. The data indicate that the product is toxicity Category III for acute dermal toxicity and eye irritation. Based on that data, two of the product labels adequately identify acute toxicity hazards. An amended label for the third product is currently under review by U.S. EPA. Once approved by U.S. EPA, the amended label will be reviewed by DPR.

For more information, please contact Ms. Ann Prichard, Senior Environmental Research Specialist in the Pesticide Registration Branch, by e-mail at <aprichard@cdpr.ca.gov> or by telephone at (916) 324-3931.


original signed by Barry Cortez


8-23-01


Barry Cortez, Chief
Pesticide Registration Branch
(916) 445-4377

Date

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