Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations 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 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 the Agency consider available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity. . . .
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
II. Toxicological Profile Consistent with FFDCA section 408b2D, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

tkelley on DSKBCP9HB2PROD with RULES

A. Overview of Complex Polymeric Polyhydroxy Acids Complex Polymeric Polyhydroxy Acids CPPA is a complex mixture of naturally occurring organic substances found in dead plant materials. The components of CPPA are widespread in nature, being found in soils and fresh and saltwater environments as a result of decaying plant materials and are used to condition agricultural soils. Its major components are humic acid, fulvic acid, and tannins, and their relative concentrations in soil and water systems are influenced by environmental conditions, such as climate, soil types, vegetation, and hydrology. CPPA is made by concentrating the organic substances from water leached through forest soil using a proprietary manufacturing process.
B. Biochemical Pesticide Toxicology Data Requirements All applicable mammalian toxicology data requirements supporting the existing tolerance exemption for residues of CPPA in or on all food commodities as a plant growth regulator
VerDate Sep<11>2014

16:57 Feb 18, 2021

Jkt 253001

have been fulfilled. The mammalian toxicology data requirements supporting the addition of nematicide use to the existing tolerance exemption have also been fulfilled as EPA has relied upon the same mammalian toxicology data that supported the existing tolerance exemption for CPPA. No acute, subchronic, or chronic toxicity endpoints were identified in guideline studies or in data obtained from open technical literature. Moreover, CPPA is not a mutagen, and is not a developmental toxicant. There are no known effects on endocrine systems via oral, dermal, or inhalation exposure. A
more in-depth synopsis of the data upon which EPA relied and its human health risk assessment based on that data can be found in the document Biopesticides Registration Action Document, Complex Polymeric Polyhydroxy Acids CPPA, which is available in Docket Number EPAHQ
OPP200909170011, as well as the docket for this action, via www.regulations.gov as described under ADDRESSES.
IV. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings residential and other indoor uses.
A. Dietary Exposure The proposed use pattern may result in dietary exposure with possible residues in or on agricultural commodities. No significant exposure via drinking water is expected beyond what is already present, when CPPA is used according to the product label directions, because the active ingredient biodegrades rapidly half-life = 25.7
days in the environment, is applied at low application rates, and is not directly applied to water. Should exposure occur, however, minimal to no risk is expected for the general population, including infants and children, due to low toxicity of CPPA and its components as demonstrated in the data submitted and evaluated by the Agency.
In addition, the lack of reported incidents in spite of the exposure from use in commercial agriculture for years to condition soils and its abundance in nature support a conclusion that minimal to no risk is expected.

PO 00000

Frm 00009

Fmt 4700

Sfmt 4700

10179

B. Other Non-Occupational Exposure Non-occupational exposure is not expected because CPPA will be applied as a plant growth regulator and nematicide for agricultural purposes only and there are no residential uses.
V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408b2Dv of FFDCA
requires that, in establishing a tolerance or tolerance exemption for a pesticide chemical residue, the Agency consider available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity. . . . EPA has determined CPPA to have a non-toxic mode of action; therefore, 408b2Dv does not apply.
VI. Determination of Safety for U.S.
Population, Infants and Children FFDCA section 408b2C provides that, in establishing a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408b2C
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 that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data are available to support the choice of a different safety factor. As part of its qualitative assessment, EPA
evaluated the available toxicity and exposure data on CPPA and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA
considers the toxicity database to be complete and has identified no residual uncertainty with regard to prenatal and postnatal toxicity or exposure. No hazard was identified based on the available studies. Based upon its evaluation, EPA concludes that there are no threshold effects of concern to infants, children, or adults when CPPA

E:FRFM19FER1.SGM

19FER1