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Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Proposed Rules
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Based on the HSRB review and comments, EPA revised the guideline and presented the revised guideline to the HSRB on June 23, 2010. EPAs Senior Policy Advisor for the Pesticide Program made a presentation titled, OPP Policy Decisions Regarding Insect Repellent Efficacy Testing. Ref. 31.
The HSRB recommended several changes or clarifications for the revised guideline in its final report, Ref. 47
including:
Removal of the maximumlikelihood method requirement in the data analysis section;
Clarification of recommendations regarding the use of positive controls, particularly with respect to the number of controls and the rationale for including them in the study;
Careful consideration of recommendations regarding the recruitment and inclusion of so-called vulnerable populations; and Encouraging the use of study designs that will enable investigators to collect data that will allow quantitative measurement of repellent efficacy in addition to determining the complete protection time CPT.
On August 6, 2010 75 FR 47592, EPA announced the availability of the final guideline for Insect Repellents to be Applied to Human Skin Guideline 810.3700.
3. Overall impact of HSRB review. As required by 40 CFR part 26, the HSRB
has reviewed and commented on all protocols for conducting skin-applied insect repellents as well as the completed studies conducted according to those protocols. In its final reports, the HSRB provided recommendations to strengthen EPAs statistical approaches for calculating CPTs. Additionally, the HSRBs feedback has resulted in EPAs development of a model to calculate sample sizes for field and lab testing with mosquitoes and lab testing with ticks, to support results. At the recommendation of the HSRB, EPA also elected not to require positive controls.
B. FIFRA Scientific Advisory Panel On March 1920, 2013, EPA
presented to the SAP a variety of issues for their consideration and response concerning the Scientific Issues Associated with Product Performance Data Needs for Pesticide Products Claiming Efficacy against Invertebrate Pests of Significant Public Health or Economic Importance. The meeting announcement, the Agencys presentations and support documents, public comments, and the comments by the SAP are available at regulations.gov using the docket identifier EPAHQ
OPP20120574. Unit VII of this
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proposal discusses how comments from the SAP and public comments informed the data requirements of proposed subpart R.
In separate actions EPA has developed and revised testing guidelines and continues to do so.
While this rule refers to these guidelines, and recommends their use, they are not the subject of todays proposal. For informational purposes, EPA is providing a description of SAP
meetings relevant to those guidelines.
1. 1994 meeting. In 1994, EPA held a 2-day meeting of the SAP to review the Agencys proposed amendments to the data requirements for pesticide registrations contained in 40 CFR part 158. The SAP was asked to comment on each data requirement and identify, in their opinion, which ones were necessary to fully and thoroughly evaluate the potential hazard of a chemical compound and which ones were not intrinsically useful in providing practical scientific information. The review included both comparative product performance data requirements along with product performance data requirements for public health and non-public health data requirements. A very complete discussion of the 1994 SAP was presented in the proposed rule for conventional pesticides March 11, 2005; 70 FR 12310 FRL68112.
2. April 2000 meeting. In April 2000
the SAP was asked to comment on a draft guideline regarding insect repellents for human skin and outdoor premises. Ref. 48.
3. July 2002 meeting. On July 3031, 2002, the SAP was asked to review the design and scientific soundness of the draft guideline entitled Termite Bait Testing. EPAs presentations, the draft guideline, the charge questions, and the Panels review of the guideline are available at regulations.gov using the docket identifier EPAHQOPP2002
0125.
4. March 2012 meeting. On March 6
7, 2012, EPA presented to the SAP, a draft guideline regarding bed bugs. The meeting announcement, the Agencys presentations and support documents, public comments, and the comments by the SAP are available at regulations.gov using the docket identifier EPAHQ
OPP20111017. After taking the SAPs feedback into consideration, EPA
announced the availability of the final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, on June 14, 2017
82 FR 27254 FRL995978.
5. May 2018 meeting. On May 810, 2018, EPA presented to the SAP for
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their consideration and response scientific issues associated with proposed revisions to two EPA Test Guidelines 810.3100 Soil Treatment for Imported Fire Ants, and Guideline 810.3500 Premises Treatment, for Red Imported Fire Ants RIFA. These guidelines were originally published in March 1998.
The proposed premises treatment guideline revisions presented to the SAP contained recommended test methodologies for a wide range of products intended to kill, control, flush, and/or knockdown invertebrate premises pests, such as cockroaches, ticks, mosquitoes, flies, and wasps. The guideline did not cover treatment of livestock or pets, wide area-mosquito control, or bed bug products. In addition to guidance for testing efficacy of direct pesticide application to pests, residual treatments, and cockroach and fly baits in the laboratory, the proposed guideline also included field testing methods for outdoor misting systems, Hymenoptera nest treatments, and outdoor foggers. Methods for resistance ratio determination and characterization of pest population strain susceptibility were also described.
The proposed RIFA treatment guideline revisions contained recommended test methodologies for evaluating the performance of pesticide products for the treatment and control of red imported fire ant colonies/
mounds. The guideline did not cover premises treatments for RIFA workers/
foragers, such as direct application to pests. Field tests for both moundand area-applied pesticide products were proposed, along with accompanying laboratory studies for baits, barrier treatments, and insect growth regulators.
The meeting announcement, the Agencys presentations and support documents, and public comments are available at regulations.gov using the docket identifier EPAHQOPP2017
0693. In September of 2019, EPA
published the final Product Performance Test Guidelines OCSPP 810.3500:
Premises Treatments; Background information, the draft guideline, and charge questions developed by EPA are available at https archive.epa.gov/
scipoly/sap/meetings/web/html/
040500_mtg.html.
7. June 2019 meeting. On June 1114, 2019, the SAP reviewed EPAs proposed guidelines for Efficacy Testing of Topically Applied Pesticides Used Against Certain Ectoparasitic Pests on Pets. The meeting announcement, the Agencys presentations and support documents, public comments, and the comments by the SAP are available at
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