5E-2.0311. Performance Standards and Acceptable Test Conditions for Preventive Termite Treatments for New Construction

(1) PERFORMANCE STANDARDS FOR PREVENTIVE TERMITE TREATMENTS FOR NEW CONSTRUCTION. The registrant of any pesticide product containing a label statement that includes directions for use as a preventive treatment for subterranean termites for new construction shall provide data to the Department demonstrating that the product meets the performance standard specified for the type of pesticide product listed below. For products registered prior to the effective date of the rule, the registrant shall have one year from the effective date of the rule to provide the data required to meet the performance standards or the period of time specified to meet the test conditions herein, whichever is greater. When data generation requires more than one (1) year, the registrant shall provide annual reports to the Department. In the event that a performance standard is not met during the test period, the provisions of Section 487.041(4)(e), F.S., shall apply.

(a) For soil applied residual treatments:

1. In field plot tests, subterranean termite damage to wood in the test must equal a rating of 9 or higher under the Standard Test Method of Evaluating Wood Preservatives by field tests with stakes, 1996, ASTM D1758-96 scale (available from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania, USA 19428-2959), in at least 90% of test samples for a minimum of five years. For products registered before the effective date of this rule, the test must equal a scale rating of 1 or better using the United States Department of Agriculture Forest Service wood damage rating scale, (modified from Verrall, A.F. 1959. Preservative moisture-repellent treatments for wooden packing boxes. For. Prod. J. 9: 1-22, available from Wood Products Insect Research Unit, 201 Lincoln Green, Starkville, MS 39759) or an ASTM scale rating of 9 or higher using ASTM D1758-96 in at least 90% of test samples for a minimum of five years.

2. In field plot tests, if the data meets the conditions of subparagraph (1)(a)1. above, then the product tested shall be considered to meet the requirement that it protects the structure and its contents from subterranean termite damage.

3. For products with label directions that allow preventative treatments for new construction other than complete coverage under a foundation, the product shall meet the performance standard specified in subparagraph (1)(d)2., and data provided to demonstrate that the performance standard was met shall be developed in accordance with paragraph (2)(c).

(b) For products formulated for use in stand-alone bait systems:

1. General. Formulated bait products submitted for registration after the effective date of this rule must be tested in field plot tests and building tests that meet the acceptable test condition requirements of paragraph (2)(b) below, and must meet the performance standards for field plot tests specified in subparagraph (1)(b)2. below, and for building tests specified in either subparagraph (1)(b)3. or (1)(b)4. below. For products registered prior to the effective date of this rule, formulated bait products must be tested in building tests that meet the requirements of paragraph (2)(b) and must meet the performance standards in either subparagraph (1)(b)3. or (1)(b)4. below to be re-registered. For products registered after the effective date of the rule, the Department shall not grant permission in Florida for a building test until subparagraph (1)(b)2. below is met.

2. Field plot tests. Field plot tests must reduce each baited termite population by a minimum of 50% or reduce wood consumption by a minimum of 50% in at least 75% of baited population colonies within 12 months of initiation of feeding on bait active ingredient; and the minimum required reduction must be maintained for at least 6 months.

3. Building Tests with Existing Infestation. Building tests with existing infestation of the building by subterranean termites must show:

a. Independent Monitors. At least a 90% reduction of termite activity in at least 90% of the test buildings where independent monitors are used as measured by independent monitoring of termite populations within 12 months after initiation of feeding on a formulated bait; and

b. Building Monitoring. The cessation of the live termite activity in at least 90% of the test buildings within twelve months after initiation of feeding on the formulated bait and:

i. No re-infestation may occur within two years as verified by visual inspection, or

ii. No re-infestation may occur within 12 months as verified by the use of a combination of research and visual inspection techniques to delineate the location of infestation such as bath trap inspection ports, moisture meters, acoustic detection, chemical detection, microwave technology, canine detection, fiber optics or infrared technology, or

iii. For building tests conducted prior to the effective date of the rule, verification of no re-infestation within 12 months using a combination of the techniques set forth in sub-subparagraph (1)(b)3.ii. above is sufficient.

4. Building Tests with No Existing Infestation. Building tests where all buildings used in the test had no existing infestation but demonstrated termite activity within 10 feet from the structure, must show:

a. Independent Monitors. At least a 90% reduction of termite activity in at least 90% of the test buildings as measured by independent monitoring of termite populations within 12 months after initiation of feeding on a formulated bait; and

b. Building Monitoring.

i. No infestation can occur in a minimum of 90% of test buildings within three years of initiation of feeding on baiting system, or

ii. Within 12 months if a 100% reduction of termite activity in the independent monitors at a minimum of 90% of the test buildings within 12 months after initiation of feeding on a formulated bait as documented using termite population delineation techniques such as mark/recapture, DNA analysis or cuticular hydrocarbon analysis and, no infestation in at least 98% of the test buildings is verified using a combination of research and visual inspection techniques to delineate the location of infestation such as bath trap inspection ports, moisture meters, acoustic detection, chemical detection, microwave technology, canine detection, fiber optics or infrared technology for 12 months after the elimination of the population.

(c) For pesticides applied to wood.

1. Field plot tests and building tests must be conducted.

2. In field plot tests, subterranean termite damage to both treated and untreated wood in the test must equal a rating of 9 or higher under the Standard Test Method of Evaluating Wood Preservatives by field tests with stakes, 1996, ASTM D1758-96 scale (available from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, Pennsylvania, USA 19428-2959), in at least 90% of test samples for a minimum of five years. For products registered before the effective date of this rule, the test must equal the USDA Forest Service scale rating of 1 or better using the United States Department of Agriculture Forest Service wood damage rating scale, (modified from Verrall, A.F. 1959. Preservative moisture-repellent treatments for wooden packing boxes. For. Prod. J. 9: 1-22, available from Wood Products Insect Research Unit, 201 Lincoln Green, Starkville, MS 39759) or a ASTM scale rating of 9 or higher using ASTM D1758-96 in at least 90% of test samples for a minimum of five years.

3. Building tests must show no infestation in a minimum of 90% of buildings in the test within five years of the treatment.

(d) For systems that use combinations of pesticides or application techniques otherwise not covered by sections above:

1. Systems registered after the date of the rule claiming to protect structures by affecting termite populations shall conduct field plot tests and building tests as specified in paragraph (2)(b) below and shall meet the performance standard for baits in field plot tests subparagraph (1)(b)2. and building tests subparagraph (1)(b)3. or (1)(b)4. above. Systems registered prior to the effective date of the rule claiming to protect structures by affecting termite populations shall conduct the building tests as specified in paragraph (2)(b) below and shall meet the performance standards in subparagraph (1)(b)3. or (1)(b)4. above.

2. Building tests must be conducted for all products other than those in subparagraph (1)(d)1. above. Building tests must show no infestation in at least 90% of buildings in the test within five years of treatment

(2) ACCEPTABLE TEST CONDITIONS FOR PREVENTIVE TERMITE TREATMENTS FOR NEW CONSTRUCTION. Acceptable test conditions for the development of data showing that the product meets the performance standard shall be as specified for the type of pesticide listed below:

(a) For soil applied residual treatments:

1. Field plot tests shall be conducted in conditions which approximate Florida conditions with respect to rainfall, temperature, soil types and termite species.

2. Field plot tests shall be conducted with at least ten replications of the treatment tested. If more replications have been used, the results of all the replications shall be reported.

3. Wood used in the tests shall not be treated to resist termite attack or shall not be wood resistant to termites as defined in Section 2304.1.1.1 of the Florida Building Code (2001 Edition, available from the Department of Community Affairs, 2555 Shumard Oak Boulevard, Tallahassee, Florida 32399).

4. Field plot tests data shall be collected from tests:

a. Accepted by the United States Environmental Protection Agency (USEPA) as in compliance with USEPA’s Product Performance Testing Guidelines for Structural Treatments (OPPTS 810.3600, EPA 712-C-98-424, March 1998, available from US EPA Office of Prevention, Pesticides, and Toxic Substances, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460); or

b. Conducted by the United States Department of Agriculture/Forest Service using the concrete slab method in their soil residual treatment testing protocol published February 11, 1994, RWU-4502-2-1994, available from the Wood Products Insect Research Unit, 201 Lincoln Green, Starkville, MS 39759; or

c. Conducted in accordance with Department approved protocols.

(b) For Stand-Alone Bait Systems:

1. Field plot tests evaluate the effect of the bait active ingredient on the population of termites. The existence of foraging population and feeding activity must be demonstrated prior to the introduction of the bait active ingredient. Field plot tests must evaluate a minimum of three (3) separate baited termite colonies and one (1) un-baited termite colony. Effect on foraging activity can be quantified by measuring consumption of foraging monitors, estimation of population size by mark/recapture techniques, or numbers of termite attacks on monitors.

2. Field plot tests and building tests shall be conducted in conditions which approximate Florida conditions with respect to rainfall, temperature, soil types and termite species.

3. For building tests conducted after the effective date of the rule, 10% of buildings with known existing infestations of subterranean termites or 10% of buildings known not to have existing infestations of subterranean termites, or ten (10) sites of each type (whichever is greater) must use independent monitors deployed in the same manner as the bait to quantify termite activity. A minimum of twenty (20) building tests must be conducted. Termite activity can be measured as wood consumption in the independent monitors, numbers of termite attacks on independent monitors, a population estimate using mark/recapture techniques, DNA analysis, or cuticular hydrocarbon analysis.

4. For all building tests initiated after the effective date of the rule, tests shall be conducted on buildings which have not been treated with a soil applied residual treatment within 5 years of the initiation of tests.

5. For building tests conducted prior to the effective date of the rule:

a. Building Tests with Existing Infestation. For building tests with existing infestation, 20% of buildings in the data set provided to the Department must have records for a minimum of two years of monitoring termite activity after the initiation of termite feeding on the formulated bait; or monitoring using a combination of research and visual inspection techniques to delineate the location of infestation such as bath trap inspection ports, moisture meters, acoustic detection, chemical detection, microwave technology, canine detection, fiber optics or infrared technology, for a minimum of 12 months after the initiation of feeding on the formulated bait.

b. Building Tests with No Existing Infestation. For building tests with no existing infestation, 20% of buildings in the data set provided to the Department must have either:

i. Records for a minimum of three years of monitoring of termite activity after the initiation of termite feeding on formulated bait; or

ii. Records using termite population delineation techniques such as mark/recapture, DNA analysis or cuticular hydrocarbon analysis for a minimum of 12 months after initiation of feeding on a formulated bait and monitoring using a combination of research and visual inspection techniques to delineate the location of infestation such as bath trap inspection ports, moisture meters, acoustic detection, chemical detection, microwave technology, canine detection, fiber optics or infrared technology, for a minimum of 12 months after the initiation of feeding on the formulated bait.

6. For tests conducted after the effective date of the rule:

a. Building tests with existing infestations must be documented with collection of termites from the test site and preservation for identification.

b. Building test inspections must include a combination of visual and research inspection methods including bath trap inspection ports, moisture meters, acoustic detection, chemical detection, microwave technology, canine detection, fiber optics or infrared technology.

c. Data from field plot and building tests must be developed under Good Laboratory Practices Standards (40 CFR Part 160, revised 2001), a United States Environmental Protection Agency quality assurance agreement, or using a Department approved protocol.

7. Building tests must use the bait as formulated for registration and must follow directions for use on the registered label or the label proposed for registration.

(c) For pesticides applied to wood:

1. Field plot tests and building tests shall have been conducted in conditions which approximate Florida conditions with respect to rainfall, temperature, soil types and termite species.

2. Field plot tests shall have been conducted with at least ten (10) replications of the treatment tested. If more replications have been used, the results of all the replications shall have been reported.

3. Field plot tests shall include at least one untreated control for each ten (10) replications.

4. Wood used in building and field plot tests that is treated shall be treated in accordance with the directions for use on the registered label or label proposed for registration.

5. Wood used in the tests shall be a species commonly used in wood frame construction in Florida.

6. For field plot tests, test units shall incorporate untreated wood placed on top of the treated wood to demonstrate that the treatment will protect untreated building components from attack by subterranean termites that require ground-soil contact.

7. For building tests conducted after the effective date of the rule, building test inspections must include bath trap inspection ports, moisture meters, acoustic detection, chemical detection, microwave technology, canine detection, fiber optics, or infrared technology.

8. Field plot tests or building test data shall be collected from tests:

a. Accepted by the United States Environmental Protection Agency (USEPA) as in compliance with USEPA’s Product Performance Test Guidelines for Structural Treatments (OPPTS 810.3600, EPA 712-C-98-424, March 1998, available from US EPA Office of Prevention, Pesticides, and Toxic Substances, 1200 Pennsylvania Avenue, N.W., Washington, DC 20460); or

b. Conducted in accordance with Department approved protocols.

9. Building tests prior to the date of the rule, shall be on a minimum of twenty-five (25) buildings with wood framed exterior walls and treatment shall have been applied according to the label or proposed label directions for use with documented annual inspections.

10. Building tests after the date of the rule shall be on a minimum of twenty-five (25) buildings with wood framed exterior walls and a minimum of ten (10) of the buildings shall have demonstrated termite activity within ten (10) feet of the structure, and treatment shall be applied according to the label or proposed label directions for use.

(d) For systems that use combinations of pesticides or application techniques otherwise not covered by sections above:

1. Systems registered after the date of the rule claiming to protect structures by affecting termite populations shall conduct field plot tests and building tests that meet the acceptable test conditions specified in paragraph (2)(b) above.

2. Systems registered prior to the effective date of the rule claiming to protect structures by affecting termite populations shall conduct building tests that meet the acceptable test conditions specified in paragraph (2)(b) above.

3. All other systems shall meet the acceptable test conditions specified in paragraph (2)(c) above.

(3) DEPARTMENT REVIEW OF DATA SUBMISSIONS.

(a) Publication of Results. The Department shall publish the results of its review of data submitted to comply with this rule within 90 days of receipt of a complete set of data developed under the acceptable test conditions established in subsection (2) above. When the Department determines that the product tested does not meet the performance standard in subsection (1), the data submitter will be allowed 90 days to provide supplemental data and data interpretations for the Department’s consideration. The Department shall review an earlier determination of failure to meet product performance standards based on this supplemental data only if additional data meets the conditions of subsection (2) above, or shall review an earlier determination based on a data interpretation only if that interpretation demonstrates that the data developed under subsection (2) above meets the performance standards established in subsection (1) above.

(b) Data from field plot tests or building tests conducted prior to the effective date of the rule. Data from field plot tests or building tests conducted prior to the effective date of the rule shall be acceptable for review by the Department if any of the following conditions are met:

1. Data and results reported are from all field plots or buildings in a study conducted in accordance with acceptable test conditions; or

2. Data and results reported are a subset of field plots or buildings with acceptable test conditions from the entire data set where all plots or buildings met acceptable test conditions, provided data were selected in a statistically random manner from the entire data set, represent a minimum of fifty (50) sites, and the method used for selection is reported and documented; or

3. Data and results reported are from all field plots or buildings with acceptable test conditions, however the entire study included plots or buildings that do not meet acceptable test conditions; or

4. Field plots or buildings reported were selected in a statistically random manner from the set of existing sites for which records that meet the acceptable test conditions requirements of subsection (2) above exist, and the results of fifty (50) sites are reported, and a description of the statistical method used is included in the data submission. Field plots or buildings reported that are a subset of field plots or buildings with acceptable test conditions from the entire data set where some plots or buildings do not meet acceptable test conditions, providing data were selected in a statistically random manner from the set of existing plots or buildings that meet acceptable conditions, represent a minimum of fifty (50) sites, and method used for selection is reported and documented.

(c) Use of Termiticide efficacy protocol review process. Termiticide efficacy protocol review process for field and building tests shall be reviewed by the Department using the Protocol Review Process for Efficacy Tests of Termiticides for Preventive Treatment for New Construction dated November 13, 2002 and hereby adopted by reference.

(d) Department Publication Following Grant of Registration. Upon granting of a registration, Department will publish the following information:

1. A description of the testing used to evaluate the product’s efficacy, including test locations and who conducted the testing.

2. The results of the efficacy testing relative to the applicable performance standards.

3. Information about which test standards and methods were used to evaluate the registration.

4. Any potential limitations to evaluating product efficacy associated with using this test method and data.

5. Any additional information that would assist the public in evaluating the product’s efficacy.

Rulemaking Authority 487.041(4)(e) FS. Law Implemented 487.041(4)(e) FS. History–New 3-23-03, Amended 12-16-03.