Voglio sapere a riguardo di…

khammond on DSKJM1Z7X2PROD with RULES

45890

Federal Register / Vol. 86, No. 156 / Tuesday, August 17, 2021 / Rules and Regulations
migration fraction 100%. EPA used an application rate of ADAOs of 1,350
ppm, which was provided by the petitioner. EPA also derived exposure amounts for population subgroups by accounting for body weights and adjusting for relative food consumption using data from the National Health and Nutrition Examination Survey NHANES specifically the 20032008
survey data.
ADAOs are currently exempt from the requirements of a tolerance under 40
CFR 180.910 for use as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest limited to 15% by weight in pesticide formulations and use as a surfactant.
One of the ADAO chemicals in the group, alkyl C10-16 dimethyl amine oxide, is also approved as an antibacterial agent in dishwashing detergent for residential use. Potential dietary exposures from these uses were included in the overall dietary exposure.
2. Dietary exposure from drinking water. The proposed use of ADAOs will not result in measurable levels in surface water or ground water and therefore will not contribute to dietary exposure.
As stated above, ADAOs are approved for preand post-harvest uses and for use in dishwashing detergent. Dietary exposures from drinking water due to these uses are included in the overall dietary exposure.
3. From non-dietary exposure. The term residential exposure is used in this document to refer to nonoccupational, non-dietary exposure e.g., textiles clothing and diapers, carpets, swimming pools, and hard surface disinfection on walls, floors, tables.
Indoor residential exposure may occur from use of ADAOs as inert ingredients in antimicrobial pesticide products applied to food contact surfaces. Indoor and outdoor residential exposure may also occur as a result of current approved uses of ADAOs in pesticide formulations for preand postharvest application and in dishwashing detergent. ADAOs are also used in soap and hair products. The Agencys assessment of residential exposure combines exposure from all of the aforementioned uses. A summary of certain other assumptions for exposure assessment of ADAOs is discussed in Unit IV.C. of the final rule published in the Federal Register of October 7, 2009
74 FR 51474 FRL84373.
4. Cumulative effects from substances with a common mechanism of toxicity.
Section 408b2Dv and c2B of
VerDate Sep<11>2014

16:18 Aug 16, 2021

Jkt 253001

FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or exemption, the Agency consider available information concerning the cumulative effects of a particular pesticides residues and other substances that have a common mechanism of toxicity.
EPA has not found ADAOs to share a common mechanism of toxicity with any other substances, and ADAOs do not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA
has assumed that ADAOs do not have a common mechanism of toxicity with other substances. For information regarding EPAs efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPAs website at http
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children Section 408b2C and c2B of FFDCA provides that EPA shall apply an additional tenfold 10X margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF
were reduced to 1X. The rationale for the Agencys determination regarding the childrens safety factor is discussed in unit IV.D of the final rule published in the Federal Register of October 7, 2009 74 FR 51474 FRL84373.
E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD aPAD and chronic PAD cPAD. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate
PO 00000

Frm 00036

Fmt 4700

Sfmt 4700

PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, ADAOs are not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described for chronic exposure, EPA has concluded that chronic exposure to ADAOs from food and water will utilize 91% of the cPAD
for children 1 to 2 years old, the population group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water considered to be a background exposure level.
ADAOs are currently used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to ADAOs.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 171 and 101 for the U.S.
population and children 1 to 2 years old, respectively. Because EPAs level of concern for ADAOs is MOEs of 100 or below, these MOEs are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water considered to be a background exposure level.
ADAOs are currently used as inert ingredients in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to ADAOs.
Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 322 and 104 for the U.S. population and children 1 to 2
years old, respectively. Because EPAs level of concern for ADAOs are MOEs
E:FRFM17AUR1.SGM

17AUR1