July 2002 Presentation BriefDraft Dated: July1, 2002
SESSION TITLE: Termite Bait Product Performance Testing Guideline
FIFRA SAP MEETING DATE: July 30-31, 2002
LEAD DIVISION/LEAD PRESENTER: Kevin Sweeney, Entomologist, OPP, RD, IB
OTHER OPP PANEL PARTICIPANTS: Marion Johnson, Acting Chief, IB, Meredith Laws, Chief, IRB, Joanne Edwards, Entomologist IRB, and George LaRocca, Team Leader and PM, IB
PURPOSE OF SESSION:
Purpose: To solicit and obtain the expert opinion and recommendations of a Scientific Advisory Panel on the design and scientific soundness of the draft EPA product performance testing guideline, OPPTS 810.3800 - Termite Baits. The guideline outlines the efficacy testing and product performance standards for Section 3 termite bait product registration.
Background: The use of termite bait products has emerged as an important method of termite control. Termite baits are used primarily to protect a structure/building from infestation and damage by termites. There are products registered and used as both preventive and curative treatments to kill termites. Because of the highly specialized nature of termite baits, a number of evaluation and labeling issues have arisen in the past six years. These issues include: 1) lack of established minimum product performance standards for termite bait product registration; 2) limitations on sale, distribution, and use by consumers; 3) labeling structural protection claims and disclaimers; 4) validity and value of efficacy data collected to fulfill registration requirements; and 5) use of termite baits as part of an integrated approach to termite control in structures. In 1998, the Federal Trade Commission and several states filed suit in Federal Court against United Industries Inc. for performance claims made with regard to the use of the EPA registered termite bait product "Terminate" EPA Reg. No. 9688-134 . The suit was settled out of court. This settlement resulted in a change of EPA approved labeling and the incorporation of a disclaimer regarding product performance.
Description of Current Termiticide Registration Practices: A performance standard represents the minimum level of product performance which would normally be acceptable, when required, for control of a pest or pest combinations at a specific site (e.g. structural protection against termites). The Agency's current product performance guidelines for soil applied liquid termiticides (OPPTS 810.3600) specify that the Ground Board and Modified Ground Board Tests are used as the standard methods for evaluating conventional soil applied termiticides. These test results, together with data collected from application of these products under actual use situations, are used by the Agency to determine minimum label application rates and appropriate directions for use. Pesticide Regulation (PR) Notice 96-7 clarified the intent of these performance guidelines and standardized termiticide product label language with respect to use directions and application methods. As to termite baits, the current OPPTS Series 810.3600 guidelines do not address efficacy testing of these products. Because of the nature of these products and for the protection of consumers, the Agency is requesting that applicants and registrants submit data that conforms to the following recommendations. In so doing, EPA generally has not registered products whose claimed level of protection is not supported by appropriate data. This new guideline addresses laboratory testing, small-scale field tests, and large scale field tests in building/structures. These tests include preventive and remedial (curative) treatment. Data required for "kill" claims are also addressed. These guidelines will be incorporated into a new OPPTS 810.3800 series guideline.
EPA POSITION: The following sets forth what we believe to be the minimum efficacy testing guidelines for termite baits intended for use as a remedial (curative) and/or preventive treatment to kill termites infesting or in proximity to a structure/building. These standards are the Agency's interpretation of the minimum product performance necessary for a termite bait to demonstrate benefit adequate for consideration of FIFRA's risk/benefit balance. EPA believes these testing protocols are necessary to offset the risks presented by ineffective termite bait applications. The Agency believes that baits claiming structural protection should be successful as a curative (remedial) treatment in laboratory bioassays and small-scale field tests (100% or 80% success within 12 months), followed by success (100% within 12 months) under actual use conditions in buildings/structures. EPA believes that termite bait success within 12 months of application should be the minimum standard because of the potential for structural damage in buildings infested by termites and to account for the seasonal nature of termite activity. Furthermore, the Agency believes it is unreasonable to expect the consumer to tolerate structural damage following the purchase and application of a termite bait product for more than one year. Although the Agency registered termite baits as preventive treatments, closer examination of the use pattern and supporting data has led us to propose additional field bioassays and applications to buildings/structures with known foraging termite populations within one meter of the building foundation. We believe preventive applications, the most difficult termite bait application to evaluate, should protect the structure (100% success) for a minimum of five years in testing under actual use conditions and continue to protect a structure for as long as the installation is continued and that these evaluations are the most appropriate tests to substantiate preventive claims.
Termite bait products for use as part of "system" or an integrated pest management approach to termite control that requires application of another insecticide product to eliminate a termite infestation should meet the minimum product performance standards based on the testing (as a stand-alone) described in the guideline. Termite baits that cannot substantiate structural protection claims (eliminate an existing termite infestation in a structure and be successful as preventive treatment) but that kill termites while not posing an unreasonable risk to humans and the environment must be registered with the kill claims only. These claims must not state or imply structural protection against termites but state only that the product kills termites. For such products, a disclaimer of structural protection must appear prominently on the label.
Because of the Agency's experience in reviewing efficacy data on liquid termiticides and termite bait products, we are recommending this testing protocol. In order to expedite the review of termite bait applications, registration amendments, and reregistration, the Agency is recommending that efficacy data be submitted with applications, amendments and reregistration documents. We believe that this data will demonstrate the efficacy of termite bait products.
EPA's policy regarding termite bait efficacy is sensitive both to the varied uses and use sites for baits. End-users need to be accurately and clearly informed as to what the product will do. Under this policy, the Agency will review termite bait products applications by dividing them into two categories: Category 1 termite baits for which data submitted to the Agency demonstrate sufficient product performance for structural protection claims; and Category 2 termite baits for which product performance data do not show efficacy at the level needed to substantiate a claim for structural protection. The Agency believes that in order to substantiate a structural protection claim the applicant or registrant should show that the product, when applied as directed, eliminates a termite infestation in field tests and under actual use conditions in structures/buildings. Category 1 products may also make preventive claims but only if successful in preventive application testing. If structural protection is not substantiated, the Agency will only allow "kills termites" claims as opposed to the structural protection claims. These Category 2 products are required to show that termites find the bait palatable and that termites are killed when they feed on the bait under actual use conditions. Category 2 products cannot make structural protection claims and must have a disclaimer of structural protection displayed prominently on the label.
I. Laboratory Bioassays
1. Laboratory termite populations should be colonized from field collected cultures of four subterranean termite species from the United States to include: Coptotermes formosanus; two species of Reticulitermes from among R. flavipes, R. virginicus, R. hesperus; and Heterotermes aureus.
2. Test laboratory termite populations cultured from the field no later than 90 days after field collection. The selection of the life stage to test will be dependent upon the pesticidal action of the active ingredient, but at a minimum should include 100 worker termites (undifferentiated nymphs of at least the third instar in the genus Reticulitermes and fifth or sixth instars of true workers in the genus Coptotermes). This determination should be made where possible for U.S. species) from the same field collection site. In addition, bioassays may include soldier caste members collected from the same site as the worker termites. Caste proportion in the test population should reflect the optimum for the test species.
3. This method uses no-choice and choice bioassays to assess active ingredient efficacy.
4. Data must be submitted that shows: 1) that the bait is palatable to termites at the active ingredient concentration(s) to be tested in the field and for commercial distribution as a registered product; 2) that the termite bait kills termites feeding directly on the bait; and 3) that the termite bait kills termites in the same population not feeding directly on bait, that is, it shows secondary kill effects.
II. Small-Scale Field Tests
Two differing approaches are proposed for SAP review and evaluation.
1) Structural protection - No infestation/feeding on protected wood. The concrete block and concrete slab methods are similar to currently used methods for evaluating soil applied termiticides. The tests simulate concrete slab construction where a concrete footer and slab are the barrier to termite penetration. The performance standards are based on the ability of the bait to protect the wood in the experimental unit from damage. Preventive and remedial treatments are tested with at least two termite bait product stations installed at each replicate. Replicates not infested with termites are used in all preventive bait treatment tests, while infested and termite free replicates are evaluated for remedial bait treatment tests. Wood and bait consumption are measured over time. Mark-release-recapture testing is used to establish connectivity between the termites at the bait stations and the wood in the experimental unit. Termites can be collected and the number of populations/colonies attacking the unit can be determined.
For the concrete block and concrete slab field test methods:1) identify the species at the site; 2) install test units; 3) randomly assign treatments (untreated, and remedial or preventive); 4) install bait product station as appropriate for the treatment; and 5) evaluate termite activity at the bait stations and test units. Use mark-release-recapture techniques to establish connectivity between foraging populations at the bait station at each unit and between the wood inside the remedial test unit and the bait stations. Measure wood and bait consumption in the untreated and remedial test units and bait consumption only at the preventive treatment units.
In preventive treatments, the bait must prevent termite attack on wood in the unit (100% success) for a minimum of five years. For remedial treatments, the infestation must be eliminated within 12 months of bait installation and not be re-infested for another 12 months. Success must be 100%.
2) Structural protection - termite population management - Grid field test in which termite populations are identified and population/colony territory is defined. The performance standard is based on ability of bait to reduce or eliminate the foraging/attacking termite population. Wood consumption and bait consumption are measured to document performance and to show that the bait eliminates termite colonies/populations. Mark-release-recapture testing is used.
For termite population management testing using termite baits, ten termite colonies of the same species will be identified in the field. The process involves the following steps: 1) identify the species at the site, 2) establish or install monitoring devices and bait delivery devices, 3) associate termites in each monitoring device with termites in other monitoring devices and bait stations to establish colony foraging areas by mark-recapture or mark-release-recapture, 4) assess wood consumption patterns to evaluate cessation of feeding, 5) randomly assign colonies to treated or control (untreated), and 6) initiate baiting and the subsequent evaluation process.
Once a site with existing termite colonies has been selected, wooden survey stakes should be driven into the ground to encourage termites to feed as specific sites (Heterotermes aureus may require a different approach (paper rolls). When the survey stakes have been fed upon by the termites, an independent monitoring device (monitoring station) can be placed adjacent to it or can replace the stake.
The performance standard is 80% success over a three year test period.
III. Large Scale Field Testing at Residential and Commercial Structures
Testing will be conducted at a minimum of 500 wooden structures. A minimum of 80 structures must in each EPA Region (3-7, 9). The baiting product and associated application materials will be used according to label directions. Termite activity and presence will be monitored - according to widely accepted practices- inside and within one meter of the structure unless termites infesting the structure can be associated with termite populations foraging at greater distances from the structure.
Two types of installations are proposed, one for preventive treatment and one for remedial treatment:
Preventive Treatments. Termites must be detected within two meters of the foundation. A minimum of 10 bait stations must be applied. The bait must prevent (100%) a structural infestation for a minimum of five years. In addition, the bait should eliminate the foraging population within one meter of the structure to provide structural protection. Independent monitoring (IM) devices will be used in addition to bait stations.
Remedial Treatments. Remedial treatments must eliminate an existing termite infestation within 12 months following bait system application in 100% of the infested structures. The treated structures must remain termite free for one year post-treatment. Alate swarms, mud tubing, and presence of worker termites in or on the structure are indications of a termite infestation and indicate failure of a bait product to protect a structure. If termites are not detected from treated structures but remained active in the monitoring station or IM, then structural inspections every month are required during the 12-month post-treatment period. After baiting eliminates the infestation in the structure based on a structural inspection but the activity resumes during the 12-month baiting period observation period at the monitoring station, additional bait application has to eliminate termite activity within 12 months at the station and IM following the re-application of baits without causing >10% wood consumption of the maximum wood consumption as recorded in the IMs during the pre-baiting period. After re-application of baits, termites should remain absent for another 12 months in the structure and the IMs.PRESENTATION BRIEF: FIFRA SCIENTIFIC ADVISORY PANEL