Voglio sapere a riguardo di…

lotter on DSK11XQN23PROD with RULES1

34144

Federal Register / Vol. 86, No. 122 / Tuesday, June 29, 2021 / Rules and Regulations
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 establishing or maintaining in effect 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 or 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 toxicological and exposure data on Bacillus subtilis strain RTI477 and considered their 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 those data can be found within the document entitled Human Health Risk Assessment for the New Active Ingredients Bacillus subtilis strain RTI477 and Bacillus velezensis strain RTI301 in the Proposed Manufacturing-use Products 279
OAUT, 279OAUI and End-use Products 279OAUO, 279OALN and 279OALR for FIFRA Section 3
Registration with Tolerance Exemption Petitions Bacillus subtilis strain RTI477 and Bacillus velezensis strain RTI301 Human Health Assessment.
This document, as well as other relevant information, is available in docket for this action as described under ADDRESSES.
The available data demonstrated that, with regard to humans, Bacillus subtilis strain RTI477 is not toxic via the pulmonary, oral, or dermal routes of exposure and is not pathogenic or infective via the pulmonary route of exposure. Although there may be some dietary and non-occupational exposures to residues of Bacillus subtilis strain RTI477 when used in accordance with
VerDate Sep<11>2014

16:11 Jun 28, 2021

Jkt 253001

label directions and good agricultural practices, there is not a concern due to the lack of potential for adverse effects.
Because there are no threshold levels of concern with the toxicity, pathogenicity, or infectivity of Bacillus subtilis strain RTI477, EPA determined that no additional margin of safety is necessary to protect infants and children as part of the qualitative assessment conducted.
Based upon its evaluation in the Bacillus subtilis strain RTI477 and Bacillus velezensis strain RTI301
Human Health Assessment, which concludes that there are no risks of concern from aggregate exposure to Bacillus subtilis strain RTI477, 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 Bacillus subtilis strain RTI477.
B. Analytical Enforcement Methodology An analytical method is not required for Bacillus subtilis strain RTI477
because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
C. Conclusion Therefore, an exemption from the requirement of a tolerance is established for residues of Bacillus subtilis strain RTI477 in or on all food commodities when used in accordance with label directions and good agricultural practices.
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, 44 U.S.C.
3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions
PO 00000

Frm 00020

Fmt 4700

Sfmt 4700

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 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 described under Title II of the Unfunded Mandates Reform Act 2 U.S.C. 1501 et seq..
This action does not involve any technical standards that would require EPAs consideration of voluntary consensus standards pursuant to section 12d of the National Technology Transfer and Advancement Act 15
U.S.C. 272 note.
V. Congressional Review Act Pursuant to the Congressional Review Act 5 U.S.C. 801 et seq., EPA will submit a report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a major rule as defined by 5 U.S.C. 8042.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

E:FRFM29JNR1.SGM

29JNR1