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EPA Quarantine Exemptions for Light Brown Apple Moth Pheromones
Current as of October 12, 2007
October 2007: A temporary restraining order issued by the California Superior Court, Monterey County, to halt the spraying of Checkmate OLR-F was based in part on the Court's uncertainty about the safety of one inert ingredient allegedly in the product. A communication from EPA to the Santa Cruz Sentinel presented an erroneous description of the ingredients in the product, and after additional review EPA has determined that Checkmate OLR-F does not in fact contain the ingredient cited by the Superior Court in its decision to issue a temporary restraining order. All of the actual ingredients of Checkmate OLR-F have been evaluated for safety and have been found to meet the Agency’s requirements for the protection of human health and the environment.
EPA is responsible for the evaluation of pesticides to ensure that they will not have unreasonable adverse effects on humans, the environment and non-target species. A pesticide cannot be legally used if it has not been registered by EPA's Office of Pesticide Programs in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Pesticide registration is the process through which EPA examines the ingredients of a pesticide; the site or crop on which it is to be used; the amount, frequency and timing of its use; and storage and disposal practices. EPA also approves emergency exemptions (under Section 18 of FIFRA) for unregistered uses of pesticides for a limited time if EPA determines that emergency conditions exist and the request meets EPA safety requirements.
EPA has evaluated and approved four products for emergency use in a quarantine program for a new invasive pest to the continental United States, the Light Brown Apple Moth (LBAM). The EPA-approved quarantine products all contain moth pheromones designed to disrupt mating and thereby reduce populations of the pest.
Detection in the California Bay Area was confirmed in February 2007. More than 5,000 detections of the moth have been confirmed over an affected area encompassing 500,000 acres or more. LBAM has the potential to cause significant economic losses due to increased production costs and the possible loss of international and domestic markets. USDA estimates the impact on plant production costs may exceed $100 million in the state of California. For questions about the Light Brown Apple Moth Eradication Project in California, call the California Department of Food and Agriculture Hotline at 1-800-491-1899.
The moth pheromone products, though artificially derived, are exact chemical replicas of the natural pheromones produced by the female LBAM to attract mates. The products impair males from finding female mates. Wide dispersal is key to product efficacy.
After a careful safety review, EPA has approved a hanging dispenser product and three additional products for ground and aerial application over wide areas where LBAM has been detected, including residential areas that harbor plant hosts for the new, invasive moth. The products are:
| Product Name | Formulation Type |
| Checkmate OLR-F | Microencapsulated |
| Checkmate LBAM-F | Microencapsulated |
| Disrupt Micro-flake LBAM Mating Disruption | Flake |
| Isomate LBAM Plus Pheromone | Hanging Dispenser |
EPA believes use of these pheromone products, including aerial application over residential areas, presents negligible risks to human health and the environment for the following reasons:
- The pheromone products approved by EPA for the quarantine program do not kill moths or other pests. Instead, the pheromones disrupt mating of the LBAM. Therefore, these products do not exhibit toxic characteristics more common to conventional pesticides. For more information see the Lepidopteran Pheromones Fact Sheet.
- The pheromones in the quarantine products fall into the chemical class of Straight Chain Lepidopteran Pheromones (SCLPs). SCLPs encompass the majority of known pheromones produced by insects in the Order Lepidoptera, which includes moths and butterflies. Low mammalian/human toxicity for this class of chemicals is well documented. Data on this class regarding inhalation toxicity, toxicity from dermal (skin) exposure, and irritation from skin and eye exposure all resulted in “non-toxic” or “practically non-toxic” classifications.? The SCLPs also showed no evidence of mutagenicity (toxicity at the genetic level). Data submitted for structurally similar SCLP pheromones also identified no subchronic, chronic or developmental risks of concern. EPA considers the low toxicity of these pheromones to humans as well-established in literature and through a long history of use. (See Refs 1, 2, 3, 4, 5).
- EPA has also reviewed all the inert ingredients in the approved LBAM products. Based on their low toxicity, all inerts in the product formulations are cleared for use in products that come in contact with food. (40 CFR 180.910, 180.920, 180.930, and/or 180.960). The inert ingredients are present in the products to provide slow release of the micro-encapsulated or flaked pheromone to prolong its effectiveness in disrupting LBAM mating (See Refs 6, 7, 8, 9 for more information).
- Other countries, such as Australia, where the LBAM is endemic, rely on the use of SCLPs. EPA is not aware of any adverse effects being reported as a result of these control programs. SCLPs are also registered in the U.S. for crop use to control other pests, with a similar track record for safe use. USEPA has received no reports of adverse effects to human health or environment associated with pheromone active ingredients registered for use in mating disruption.
- In terms of exposure to the pheromones, pesticide applicators would be expected to receive the most exposure because they handle the concentrated product. However, even for the applicators, the expected level of exposure is not of concern. In addition, the product labels have standard precautionary information for handlers to follow. (see attached labels).
- Residential and by-stander exposure is expected to be low due to the low application rate and the specific methods of application. EPA believes use of these pheromone products, including aerial application over residential areas, presents negligible risks to human health and the environment. Furthermore, there are no restrictions for re-entering treated residential or recreational areas.
- LBAM and other SCLP pheromones naturally occur in the quarantine areas due to the presence of LBAM females and other Lepidopteran pests. Releasing the LBAM pheromone disrupts the mating cycle of the pest. These pheromone mating disrupters are very specific to targeted moth species, and are not expected to cause adverse effects or responses in humans or any other species, including the Monarch butterfly. SCLPs are biodegradable by enzyme systems in most living organisms and should present no problem to normal physiology.
- EPA carefully evaluated the safety of the requested quarantine uses of these pheromone products and supports their use, and as noted previously, believes the risks to human health and the environment are negligible. In addition, the alternative approaches and controls to use of pheromones might include more traditional pesticides that would kill the pests rather than disrupt their mating cycle. Populations of threatened and endangered plant species could also be further impacted if this moth adapts to feeding on them as it has on many other plant hosts.
Background
EPA reviewed and approved use of these products as authorized by Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and under its own regulations at 40 CFR Part 166 (Ref 10).
Under these provisions, a state or other federal agency may apply for emergency use of a new pesticide or use pattern in order to help respond to an urgent new pest problem, such as the discovery of an invasive and damaging insect pest like LBAM. This program for release of pheromones in mating disruption is considered a “quarantine” emergency.
LBAM is native to Australia and is found in New Zealand, Ireland, the United Kingdom, and Hawaii. The pest destroys, stunts, or deforms young seedlings, spoils the appearance of ornamental plants, and injures deciduous fruit-tree crops, citrus, and grapes.
References
- Guidance for Registration Requirements for Pheromones and Semiochemicals Used for Arthropod Pest Control. OECD Series on Pesticides. No. 12. Feb. 26, 2002 (25 pp, 77K , About PDF)
- Touhey, J.G. ca.1990. A review of the current bases for the United States Environmental Protection Agency’s policies for the regulation of pheromones and other semiochemicals, together with a review of the available relevant data which may impact the assessment of risk for these classes of chemicals. Part No.1, Straight Chain Alcohols, Acetate Esters and Aldehydes. (Unpublished report, 474 pp.)
- Amended SCLP Tolerance Exemption Final Rule published in the Federal Register 8/9/06
- SCLP Tolerance Exemption Final Rule published in the Federal Register 8/9/95
- The 1/26/94 Federal Register Document titled Arthropod pheromones in Solid Matrix Dispensers: Experimental Use Permit.
- 40 CFR 180.910. Inert Ingredients Used Pre- and Post-harvest; Exemptions from the Requirements of a Tolerance
- 40 CFR 180.920. Inert Ingredients Used Pre-harvest; Exemptions from the Requirements of a Tolerance
- 40 CFR 180.930. Inert Ingredients Applied to Animals; Exemptions from the Requirements of a Tolerance.
- 40 CFR 180.960. Polymers; Exemptions from the Requirements of a Tolerance.
- 40 CFR 166. Exemption of Federal and State Agencies for Use of Pesticides Under Emergency Conditions.
- California Department of Food and Agriculture
- National Pesticide Information Center Hotline: 1-800-858-7378