Federal Register - March 22, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Proposed Rules
ourfocus/planthealth/plant-pest-anddisease-programs/pests-and-diseases/
emerald-ash-borer accessed March 9, 2020.
26. USDA. Asian Long-Horned Beetle, available at https
www.invasivespeciesinfo.gov/profile/
asian-long-horned-beetle, accessed March 9, 2020.
27. NRS. Economic Impacts of Non-Native Forest Insects in the Continental United States, available at https
www.nrs.fs.fed.us/pubs/38719 accessed March 9, 2020.
28. US EPA. Technical Support Document Scientific Issues Associated with Product Performance Data Needs for Pesticide Products Claiming Efficacy against Invertebrate Pests of Significant Public Health or Economic Importance Submitted to the FIFRA Scientific Advisory Panel for Review and Comment March 1921, 2013 Hereinafter TSD, available in docket: EPAHQOPP
201205740002, Appendix 1, Tables I
and II.
29. US EPA. FIFRA Scientific Advisory Panel, Meeting Minutes and Final Report for the March 1921, 2013 Scientific Advisory Panel, available at https
www.epa.gov/sites/production/files/
2015-06/documents/031913minutes.pdf accessed April 9, 2020.
30. World Health Organization WHO.
Guidelines for Efficacy Testing of Mosquito Repellents for Human Skin, available at http whqlibdoc.who.int/hq/
2009/WHO_HTM_NTD_WHOPES_
2009.4_eng.pdf accessed March 23, 2020.
31. US EPA. OPP Policy Decisions Regarding Insect Repellent Efficacy Testing, prepared for June 23, 2010, Human Subjects Research Board Meeting.
32. USDA. National Invasive Species Information Center, available at https
www.invasivespeciesinfo.gov/ accessed April 29, 2020.
33. Consumer and Specialty Products Association CSPA. Comment submitted by Beth Law, CSPA, March 15, 2013, EPAHQOPP201205740014.
34. USDA. Victor Borne Diseases: Cattle Fever Ticks, available at https
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/animal-diseaseinformation/cattle-disease-information/
cattle-vector-borne-diseases accessed March 9, 2020.
35. Bovine Babesiosis, available at cfsph.iastate.edu/factsheets/pdfs/
bovine_babesiosis.pdf accessed March 24, 2020.
36. S.C. Johnson & Son, Inc. Comment submitted by Jill Geyser, S.C. Johnson &
Son, Inc., March 9, 2013, EPAHQOPP
201205740011.
37. UF IFAS. Featured Creatures: Human Bot Fly, available at http
entnemdept.ufl.edu/creatures/misc/flies/
human_bot_fly.htm accessed March 9, 2020.
38. USDA. National Agricultural Library, New World Screwworms, available at https www.nal.usda.gov/exhibits/
speccoll/exhibits/show/stop-
VerDate Sep<11>2014
20:06 Mar 19, 2021
Jkt 253001
screwworms--selections-fr/introduction accessed March 9.
39. US EPA. EPAs Guideline 810.3700, entitled, Insect Repellents to be Applied to Human Skin, available at https www.epa.gov/test-guidelinespesticides-and-toxic-substances/series810-product-performance-test-guidelines accessed July 1, 2020.
40. Comment submitted by Dudley Hoskins, Responsible Industry for a Sound Environment, March 10, 2013, EPAHQ
OPP201205740009.
41. Comment submitted by Beth Law, Consumer and Specialty Products Association, March 15, 2013, EPAHQ
OPP201205740014.
42. CDC. Parasites-Leishmaniasis, available at https www.cdc.gov/parasites/
leishmaniasis/index.html accessed March 16, 2020.
43. Comment submitted by Brian Forschler, Termiticide Scientific Review Panel, March 19, 2013, EPAHQOPP2012
05740016.
44. US EPA. Science Adviser Programs:
Human Studies Review Board, available at https www.epa.gov/osa/humanstudies-review-board accessed April 1, 2010.
45. US EPA. Draft Guideline 810.3700, Insect Repellents to be applied to Human Skin https archive.epa.gov/osa/hsrb/web/
pdf/guidelines-for-performance-testingof-skin-applied-insect-repellents9.23.08.pdf accessed April 1, 2020.
46. US EPA. October 2122, 2008 EPA
Human Studies Review Board Meeting Report, available at https
archive.epa.gov/osa/hsrb/web/pdf/
october2008hsrbb finaldraftreport12808.pdf accessed April 9, 2020.
47. US EPA. EPA Human Studies Review Board Meeting Report, June 23, 2010.
Available at https archive.epa.gov/osa/
hsrb/web/pdf/june2010
finalreport090910.pdf accessed April 14, 2020.
48. US EPA. Background Information, the Draft Guideline, and Charge Questions Developed by EPA, available at https
archive.epa.gov/scipoly/sap/meetings/
web/html/040500_mtg.html.
49. US EPA. Proposed Rule-related ICR
Amendment for Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests RIN 2070
AJ49, EPA ICR No.: 0277.20 and OMB
Control No.: 2070-tbd. November 2020.
XIII. FIFRA Review Requirements Pursuant to FIFRA section 25a, EPA
submitted the draft proposed rule to the Secretary of Agriculture USDA and the FIFRA SAP for review. A draft of the proposed rule was also submitted to the appropriate Congressional Committees.
XIV. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be
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found at https www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget OMB for review under Executive Orders 12866
58 FR 51735, October 4, 1993 and 13563 76 FR 3821, January 21, 2011.
Any changes made in response to OMB
recommendations have been documented in the docket. EPA
prepared an analysis of the potential costs and benefits associated with this action Ref. 1 which is summarized in more detail in Unit I.E. This analysis is available in the docket.
B. Paperwork Reduction Act PRA
The information collection activities in this proposed rule have been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request ICR
document that EPA prepared is assigned EPA ICR No. 0277.20 and OMB Control No.: 20700060 Ref. 49. You can find a copy of the ICR in the docket and it is briefly summarized here.
The information collection activities in this proposed rule are associated with the codification of efficacy data requirements against certain invertebrate pests. These information collection activities are activities associated with the application for a new or amended registration of a pesticide and are currently approved by OMB under OMB Control No. 2070
0060 EPA ICR No. 0277. As such, this ICR is intended to amend that existing ICR at the final rule stage, incorporating the information collection activities attributable to this proposed rule, including a reduction in transaction costs associated with a clear codification of the product performance data requirements for certain invertebrate pests.
Respondents/affected entities: There are three groups impacted by the rule.
Chemical producers NAICS 32532, colleges, universities, and professional schools NAICS code 611310, and research and development labs and services NAICS code 541712.
Respondents obligation to respond:
These data must be submitted for the applicant to receive the desired pesticide registration or label claim.
Authorizing legislation is contained in Section 3 of FIFRA 7 U.S.C. 136. The implementing regulations specific to the product performance data requirements are contained in 40 CFR part 158.
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