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Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Rules and Regulations response to this comment is discussed in Unit III.C.

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III. Final Rule A. EPAs Safety Determination Section 408c2Ai of FFDCA
allows EPA to establish an exemption from the requirement for a tolerance the legal limit for a pesticide chemical residue in or on a food only if EPA
determines that the exemption is safe.
Section 408c2Aii of FFDCA
defines safe to mean that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408c2B, in making a safety determination to establish an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408b2C, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption and to ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . . Additionally, FFDCA section 408b2D requires that EPA consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.
EPA evaluated the available toxicity and exposure data on Purpureocillium lilacinum strain PL11 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA
relied and its risk assessment based on that data can be found within the May 20, 2021, document entitled Federal Food, Drug, and Cosmetic Act FFDCA
Safety Determination for Purpureocillium lilacinum strain PL11.
This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.
The available data demonstrated that, with regard to humans, Purpureocillium lilacinum strain PL11 is not toxic, pathogenic, or infective via any reasonably foreseeable route of exposure. Although there may be dietary and non-occupational exposure to residues when Purpureocillium lilacinum strain PL11 is used on food
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commodities, there is not a concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act safety factor for infants and children under FFDCA 408b2C was not necessary as part of the qualitative assessment conducted for Purpureocillium lilacinum strain PL11.
Based upon its evaluation, EPA
concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Purpureocillium lilacinum strain PL11. Therefore, an exemption from the requirement of a tolerance is established for residues of Purpureocillium lilacinum strain PL11
in or on all food commodities when used in accordance with label directions and good agricultural practices.
B. Analytical Enforcement Methodology An analytical method for enforcement purposes is not required because EPA
has determined that reasonably foreseeable exposure to residues of Purpureocillium lilacinum strain PL11
from use of the pesticide will be safe, due to lack of toxicity, pathogenicity, and infectivity. Under those circumstances, it is unnecessary to have an analytical method to monitor for residues.
C. Response to Comments One comment was received in response to the notice of filing. The comment discusses concerns regarding the use of GRAS generally recognized as safe determinations to support decisions regarding pesticide products and promotes a complete review of data. Consistent with FFDCA
section 408b2D, EPA reviews the available scientific data and other relevant information and considers their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA also considers available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. EPA relied on a variety of data and information to make a risk determination on Purpureocillium lilacinum strain PL11. For more information on the human health risk assessment of Purpureocillium lilacinum strain PL11, please see the supporting documentation provided in the associated regulatory docket search for EPAHQOPP20160079 at www.regulations.gov.

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IV. Statutory and Executive Order Reviews This action establishes a tolerance exemption under FFDCA section 408d in response to a petition submitted to EPA. The Office of Management and Budget OMB has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review 58 FR 51735, October 4, 1993. Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use 66
FR 28355, May 22, 2001, or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885, April 23, 1997. This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act PRA, 44
U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations 59 FR 7629, February 16, 1994.
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408d, such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act RFA 5
U.S.C. 601 et seq. do not apply.
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408n4. As such, EPA has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, EPA has determined that Executive Order 13132, entitled Federalism 64 FR 43255, August 10, 1999, and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments 65 FR
67249, November 9, 2000, do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as
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