Quiero saber acerca de...

44622

Federal Register / Vol. 86, No. 154 / Friday, August 13, 2021 / Rules and Regulations
jbell on DSKJLSW7X2PROD with RULES

determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408c2A, and the factors specified in FFDCA section 408c2B, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure to pyrrolo3,4cpyrrole-1,4-dione, 3,6-bis4chlorophenyl-2,5-dihydroincluding exposure resulting from the exemption established by this action. EPAs assessment of exposures and risks associated with pyrrolo3,4-cpyrrole1,4-dione, 3,6-bis4-chlorophenyl-2,5dihydrofollows.
A. Toxicological Profile EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by pyrrolo3,4-cpyrrole-1,4-dione, 3,6bis4-chlorophenyl-2,5-dihydroalso referred to as Pigment Red 254 as well as the no-observed-adverse-effect-level NOAEL and the lowest-observedadverse-effect-level LOAEL from the toxicity studies are discussed in this unit.
Available acute toxicity studies on Pigment Red 254 show low oral, dermal, and inhalation toxicity. An eye irritation, a dermal irritation, and a dermal sensitization study were also available and showed no effect of treatment. No adverse effects of treatment were seen in rats in either a 28-day oral toxicity study or a reproduction/developmental toxicity study at the highest dose tested 1,000
mg/kg/day. Therefore, the NOAEL for the 28-day study and the parental, reproductive, and developmental NOAELs are 1,000 mg/kg/day.

VerDate Sep<11>2014

16:00 Aug 12, 2021

Jkt 253001

There was no evidence of carcinogenicity or neuropathological changes or effects reported in any of the studies. There were no in vivo or in vitro mutagenic effects in mutagenicity testing with Pigment Red 254. The agency does not believe Pigment Red 254 will be carcinogenic or neurotoxic.
B. Toxicological Points of Departure/
Levels of Concern No toxicological endpoint of concern for Pigment Red 254 has been identified in the database.
C. Exposure Assessment 1. Dietary exposure from food, feed uses, and drinking water. In evaluating dietary exposure to Pigment Red 254, EPA considered exposure under the current and proposed uses of Pigment Red 254. Dietary exposure to Pigment Red 254 may occur from eating foods treated with pesticide formulations containing this inert ingredient and drinking water containing runoff from soils containing the treated crops. In addition, Pigment Red 254 is used as an indirect food additive. However, no toxicological endpoint of concern was identified for Pigment Red 254, and therefore, a quantitative assessment of dietary exposure is not necessary.
2. Non-dietary exposure. The term residential exposure is used in this document to refer to non-occupational, non-dietary exposure e.g., textiles clothing and diapers, carpets, swimming pools, and hard surface disinfection on walls, floors, tables.
Residential exposure to Pigment Red 254 may occur based on its use as an inert ingredient in pesticide formulations registered for residential uses. Additional non-dietary exposure may occur from use of Pigment Red 254
in consumer products. However, no toxicological endpoint of concern was identified for Pigment Red 254, and therefore, a quantitative residential exposure assessment for Pigment Red 254 was not conducted.
3. Cumulative effects from substances with a common mechanism of toxicity.
Section 408b2Dv of 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 Pigment Red 254
to share a common mechanism of toxicity with any other substances, and Pigment Red 254 does not appear to produce a toxic metabolite produced by other substances. For the purposes of
PO 00000

Frm 00050

Fmt 4700

Sfmt 4700

this action, therefore, EPA has assumed that Pigment Red 254 does 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 of the FFDCA
requires EPA to retain an additional tenfold margin of safety in the case of threshold effects 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. As noted in Unit IV.B., there is no indication of threshold effects being caused by Pigment Red 254. Therefore, this requirement does not apply to the present analysis.
Moreover, due to the lack of any toxicological endpoints of concern, EPA
conducted a qualitative assessment of Pigment Red 254, which does not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.
E. Aggregate Risks and Determination of Safety Taking into consideration all available information on Pigment Red 254, EPA
has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to Pigment Red 254 residues.
Therefore, the establishment of exemptions from the requirement of a tolerance under 40 CFR 180.910 for residues of Pigment Red 254 when used as an inert ingredient in pesticide formulations preand postharvest is safe under FFDCA section 408.
V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
B. Response to Comments One comment was received which asserted that Pigment Red 254 contains chlorine gas and opposed its use;
however, chlorine gas is not a constituent nor a metabolite/degradate of Pigment Red 254 and is therefore not relevant to the assessment of this chemical.

E:FRFM13AUR1.SGM

13AUR1