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Federal Register / Vol. 86, No. 164 / Friday, August 27, 2021 / Rules and Regulations
the exemptions established by this action. For a description of the Agencys approach to and assumptions for the exposure assessments, see Unit IV.C. of the August 5, 2009 rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor for infants and children from 10X to 1X. See Unit IV.D.
of the August 5, 2009 rulemaking for a discussion of the Agencys rationale for that determination.
Aggregate Risks and Determination of Safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose aPAD and the chronic population adjusted dose cPAD. Short, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure MOE
exists. For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.
An acute dietary exposure assessment was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD with a value of 37%
of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. EPA
concluded that the shortand intermediate-term aggregated food, water, and residential exposures both resulted in an aggregate MOEs of 110 for children. As the level of concern is for MOEs that are lower than 100, these MOEs are not of concern. The AAAs are not expected to be carcinogenic as described in Unit IV.C. of the August 5, 2009 rulemaking. Therefore, a cancer dietary exposure assessment is not necessary to assess cancer risk.
Based on the risk assessment and information described above, EPA
concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to AAA
residues, including residues of alcohols, C1618, distn. residues, ethoxylated, propoxylated CAS Reg. No. 2409830
335; alcohol, C22, ethoxylated CAS
Reg. No. 26636408; polyoxy-1,2ethanediyl, a-2-butyloctyl-w-hydroxyCAS Reg. No. 60636375; 2octyldodecan-1-ol, ethoxylated CAS
Reg. No. 32128657; and alcohols, C1620, branched, ethoxylated CAS
Reg. No. 161133706. More detailed
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information about the Agencys analysis can be found at http
www.regulations.gov in the documents titled Alkyl Alcohol Alkoxylates AAAJITF CST 1 Inert Ingredient, Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations and Alkyl Alcohol Alkoxylates AAAJITF CST 1 Inert Ingredient, Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance Under 40 CFR 180.960 When Used as an Inert Ingredient in Pesticide Formulations in docket ID number EPAHQOPP20090145.
V. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing exemptions from the requirement of a tolerance without any numerical limitation.
VI. Conclusions Therefore, exemptions from the requirement of a tolerance are established for residues of the following a-alkyl-w-hydroxypolyoxypropylene and/or poly oxyethylene polymers where the alkyl chain contains a minimum of 6 carbons: alcohols, C16
18, distn. residues, ethoxylated, propoxylated CAS Reg. No. 2409830
335; alcohol, C22, ethoxylated CAS
Reg. No. 26636408; polyoxy-1,2ethanediyl, a-2-butyloctyl-w-hydroxyCAS Reg. No. 60636375; 2octyldodecan-1-ol, ethoxylated CAS
Reg. No. 32128657; and alcohols, C1620, branched, ethoxylated CAS
Reg. No. 161133706 when used as inert ingredients in pesticide formulations preand post-harvest under 40 CFR 180.910, applied to animals under 40 CFR 180.930, and in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils under 40 CFR 180.940a. Additionally, exemptions from the requirement of a tolerance are established under 40 CFR
180.960 for residues of these substances with a minimum number average molecular weight in amu of 1,100
when used as an inert ingredient in pesticide formulations, including antimicrobial formulations.
VII. Statutory and Executive Order Reviews This action establishes exemptions from the requirement of a tolerance under FFDCA section 408d in response to a petition submitted to the Agency. The Office of Management and
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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 exemptions in this final rule, 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, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA
section 408n4. As such, the Agency 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, the Agency 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 UMRA 2 U.S.C. 1501 et seq..
This action does not involve any technical standards that would require Agency consideration of voluntary
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