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Federal Register / Vol. 86, No. 199 / Tuesday, October 19, 2021 / Rules and Regulations those rulemakings as described further in this rulemaking, as they remain unchanged.
A. Toxicological Profile For a summary of the Toxicological Profile of propamocarb, see Unit III.A. of the December 5, 2019 rulemaking 84 FR
66616 FRL1000033.

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B. Toxicological Points of Departure/
Levels of Concern For a summary of the Toxicological Points of Departure/Levels of Concern used for the risk assessment, see Unit III.B. of the February 7, 2017 rulemaking 82 FR 9519 FRL995768.
C. Exposure Assessment Much of the exposure assessment remains the same, although the dietary exposure and risk assessments for propamocarb were updated. These updates are discussed in this section; for a description of the rest of EPAs approach to and assumptions for the exposure assessment, see Unit III.C. of the December 5, 2019 rulemaking.
EPAs dietary exposure assessments have been updated to include the additional exposures for the new use of propamocarb on the commodities in crop group 516. The assessment used the same assumptions as the December 5, 2019 rule concerning tolerance-level residues, default and empirical processing factors and 100% crop treated PCT for all commodities in both the acute and chronic dietary exposure assessments.
Drinking water, non-occupational, and cumulative exposures. Drinking water and non-occupational exposures are not impacted by the new use, and thus have not changed since the last assessment. For a summary of the dietary exposures from drinking water, see Unit III.C.2. of the December 5, 2019
rulemaking. Propamocarb is registered for use on golf course turf resulting in potential residential post-application dermal exposure. During Registration Review, a dermal endpoint was not selected; therefore, a quantitative residential dermal exposure assessment was not necessary and was not conducted. EPAs conclusions concerning cumulative risk remain unchanged from Unit III.C.4. of the December 5, 2019 rulemaking.
Safety factor for infants and children.
EPA continues to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the FQPA SF
were reduced from 10X to 1X for all exposure scenarios. The reasons for that decision are articulated in Unit III.D in the December 5, 2019 rulemaking.

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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.
Acute dietary risks are below the Agencys level of concern of 100% of the aPAD; they are 42% of the aPAD for all infants, the most highly exposed subpopulation. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD; they are 54% of the cPAD for females 13 to 49 years old, the most highly exposed subpopulation.
A short-and intermediate-term oral adverse effect was identified; however, propamocarb is not registered for any use patterns that would result in either shortor intermediate-term oral residential exposure. Shortand intermediate-term risk is assessed based on shortand intermediate-term residential exposure plus chronic dietary exposure. Because there is no shortor intermediate-term oral residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD which is at least as protective as the POD used to assess shortor intermediate-term risk, no further assessment of shortor intermediateterm risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating shortand intermediate-term risk for propamocarb. Additionally, based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, propamocarb is not expected to pose a cancer risk to humans.
Therefore, based on the risk assessments 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 propamocarb residues.
More detailed information about the Agencys analysis can be found at https www.regulations.gov in the document titled Propamocarb Hydrochloride HCl. Human Health Risk Assessment for Proposed Uses in/
on Vegetable, Brassica, Head and Stem, group 516 in docket ID number EPA
HQOPP20200347.

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IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the December 5, 2019
rulemaking.
B. International Residue Limits In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits MRLs established by the Codex Alimentarius Commission Codex, as required by FFDCA section 408b4.
The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA
may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408b4 requires that EPA explain the reasons for departing from the Codex level.
Codex MRLs for residues of propamocarb in/on cabbage, cauliflower, and broccoli are 3 ppm, 2
ppm, and 1 ppm, respectively. As these levels are significantly less than the recommended tolerance level of 15 ppm for Vegetable, Brassica, head and stem, group 516, harmonization is not possible because U.S. growers could have violative residues despite legal use of propamocarb according to the label.
C. Response to Comments Two comments were submitted to the docket in response to the September 10, 2020 Notice of Filing. The first commenter stated that there need to be regulations for residues of pesticide chemicals in/on various commodities but expressed concern about the increasing use of pesticides. The commenter urged EPA to fully evaluate the submitted data as soon as possible to protect the U.S. public. Another commenter expressed concerns regarding producers making products cheaper or using pesticides for economic gain without considering human health. The commenter stated that the government should have the ability to monitor the chemicals put into food.
The Agency appreciates these comments and believes that the laws applicable to pesticide tolerances address these concerns. Specifically, the existing legal framework provided by
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