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Federal Register / Vol. 86, No. 183 / Friday, September 24, 2021 / Rules and Regulations
that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment.
PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed the NOAEL and the lowest dose at which adverse effects of concern are identified the LOAEL. Uncertainty/
safety factors are used in conjunction with the POD to calculate a safe exposure levelgenerally referred to as a population-adjusted dose PAD or a reference dose RfDand a safe margin of exposure MOE. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological endpoints for metalaxyl used for the human health risk assessment is shown in the Metalaxyl Human Health Risk Assessment for the Proposed Tolerances in/on White and Black Pepper without a U.S. Registration, and further explanation can be found in Metalaxyl, Mefenoxam metalaxyl-m Human Health Draft Risk Assessment for Registration Review.
C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to metalaxyl, EPA considered exposure under the existing tolerances for mefenoxam and the existing and petitioned-for tolerances for metalaxyl.
EPA assessed dietary exposures in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.
In conducting acute dietary exposure assessment, EPA used the 20032008
food consumption data from the U.S.
Department of Agricultures National Health and Nutrition Examination Survey, What We Eat in America NHANES/WWEIA. A partially refined acute dietary exposure assessment was conducted for metalaxyl. The refinement was based on a tolerance level adjustment to account for all residues of concern and anticipated
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residues were used for livestock commodities. The analysis used tolerance-level residues, adjusted to include additional residues of concern, and 100 percent crop treated PCT.
ii. Chronic exposure. Because no chronic dietary endpoint was selected, a chronic dietary exposure assessment was not conducted. Nevertheless, for purposes of assessing short-term aggregate risk, EPA calculated average dietary exposures. In conducting the chronic dietary exposure assessment, EPA used tolerance level values adjusted for additional residues of concern and 100 PCT.
iii. Cancer. Metalaxyl is classified as Not Likely to Be Carcinogenic to Humans therefore, a cancer assessment is not needed.
2. Dietary exposure from drinking water. Drinking water exposures are not impacted by the import tolerances on black pepper; therefore, the assessment for this tolerance action relied on the second refinement for the drinking water exposure assessment DWA for metalaxyl and mefenoxam, in support of the Agency human health assessment for Registration Review for the estimated drinking water concentrations EDWCs. See Metalaxyl/Mefenoxam:
Second Refinement Addendum to Drinking Water Exposure Assessment in Support of Registration Review, which is located at https
www.regulations.gov in docket ID
number EPAHQOPP20090863.
That assessment modeled drinking water exposures using the Pesticide Root Zone Model PRZM, v5, November 15, 2006 and the Variable Volume Water Body Model VVWM, March 6, 2014 for surface water and the PRZM
GW for groundwater. Using those models, EPA calculated the following EDWCs for use in exposure assessment:
350 ppb for acute exposure assessment and 135 ppb for chronic exposure assessment.
3. Non-dietary exposure. The term residential exposure is used in this document to refer to non-occupational, non-dietary exposure e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets.
Mefenoxam and metalaxyl are currently registered for the following uses that could result in residential exposures: Lawns, ornamentals, gardens, and trees. EPA assessed residential exposure using the following assumptions: For residential handlers, all registered metalaxyl and mefenoxam product labels with residential use sites lawns, ornamentals and garden and trees require that handlers wear specific clothing e.g., long-sleeve shirt/

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long pants and chemical-resistant gloves. Therefore, EPA has made the assumption that these products are not for homeowner use and has not conducted a quantitative residential handler assessment.
There is potential for residential postapplication exposures to metalaxyl.
Since no dermal endpoints were identified, only incidental oral postapplication exposures to small children ages 1 to <2 have been assessed.
Metalaxyl and mefenoxam are registered for use on home lawns; therefore, there is the potential for incidental oral exposure hand-to-mouth, object-tomouth, soil ingestion and granular ingestion.
The recommended residential exposure for use in the children 1 to <2
years old aggregate assessment reflects hand-to-mouth incidental oral exposures from treated turf using a liquid formulation. Ingestion of granules is considered an episodic event and not a routine behavior. Because the Agency does not believe that this would occur on a regular basis, the concern for human health is related to acute poisoning rather than short-term residue exposure. Therefore, an acute dietary dose is used to estimate exposure and risk resulting from episodic ingestion of granules. For these same reasons, the episodic ingestion scenario was not included in the aggregate assessment.
A summary of the residential exposures for metalaxyl used for the human health risk assessment can be found in Metalaxyl, Mefenoxam metalaxyl-m Human Health Draft Risk Assessment for Registration Review docket ID number EPAHQOPP2009
08630023.
Further information regarding EPA
standard assumptions and generic inputs for residential exposures may be found at http www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
standard-operating-proceduresresidential-pesticide.
4. Cumulative effects from substances with a common mechanism of toxicity.
FFDCA section 408b2Dv requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.
Unlike other pesticides for which EPA
has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to mefenoxam and any other substances and mefenoxam does not appear to produce a toxic metabolite produced by
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