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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations
foods. Section 408 of FFDCA, 21 U.S.C.
346a, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications of tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, pesticide residues in or on food is considered unsafe, 21 U.S.C.
346aa1, and such food, which is then rendered adulterated under FFDCA
section 402a, 21 U.S.C. 342a, may not be distributed in interstate commerce, 21 U.S.C. 331a.
Section 408b2 of the FFDCA
directs that EPA may establish or leave in effect a tolerance for a pesticide only if it finds that the tolerance is safe, and EPA must revoke or modify tolerances determined to be unsafe. FFDCA
408b2Ai 21 U.S.C.
346ab2Ai. Section 408b2Aii defines safe to mean that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. This includes exposure through food, drinking water and all non-occupational exposures e.g., in residential settings, but does not include occupational exposures to workers i.e., occupational. Risks to infants and children are given special consideration. Specifically, pursuant to section 408b2C, EPA must assess the risk of the pesticide chemical based on available information concerning the special susceptibility of infants and children to the pesticide chemical residues, including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals;
and available information concerning the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity. 21 U.S.C.
346ab2CiII and III.
This provision further directs that in the case of threshold effects, . . . an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential preand postnatal toxicity and completeness of the data with respect to exposure and toxicity to infants and children. 21 U.S.C. 346ab2C.
EPA is permitted to use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children. 21 U.S.C.
346ab2C. Due to Congresss focus on both preand postnatal toxicity, EPA

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has interpreted this additional safety factor as pertaining to risks to infants and children that arise due to prenatal exposure as well as to exposure during childhood years. This section providing for the special consideration of infants and children in section 408b2C was added to the FFDCA through the Food Quality Protection Act FQPA Pub. L.
104170, 110 Stat. 1489 1996;
therefore, this additional margin of safety is often referred to as the FQPA
safety factor SF.
Section 408d of the FFDCA, 21
U.S.C. 346ad, authorizes EPA to revoke tolerances in response to an administrative petition submitted by any person. As explained in more detail in Unit IV, PANNA and NRDC
submitted a petition in 2007 requesting revocation of all chlorpyrifos tolerances.
The Ninth Circuit has directed EPA to grant that petition and issue a rule revoking or modifying those tolerances.
EPA is issuing this rule in response to that petition and revoking all chlorpyrifos tolerances because EPA is unable to determine, based on data available at this time, that aggregate exposures to chlorpyrifos are safe.
B. Federal Insecticide, Fungicide, and Rodenticide Act FIFRA Registration Review Under FIFRA, a pesticide may not be sold or distributed in the United States unless it is registered. 7.U.S.C. 136aa.
EPA must determine that a pesticide will not generally cause unreasonable adverse effects on the environment in order to register a pesticide. 7 U.S.C.
136ac5. The term unreasonable adverse effects on the environment is defined to include a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of Title 21. 7 U.S.C.
136bb. Thus, the FIFRA registration standard incorporates the FFDCA safety standard and requires consideration of safety at the time of registration and during the registration review process.
Under section 3g of FIFRA 7 U.S.C.
136ag, EPA is required to re-evaluate existing registered pesticides every 15
years in a process called registration review. The purpose of registration review is to ensure that each pesticide registration continues to satisfy the FIFRA standard for registration, 40
CFR 155.40a1, taking into account changes that have occurred since the last registration decision, including any new relevant scientific information and any changes to risk-assessment procedures, methods, and data requirements. 40 CFR 55.53a. To ensure that a pesticide continues to
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meet the standard for registration, EPA
must determine, based on the available data, including any additional information that has become available since the pesticide was originally registered or re-evaluated, that the pesticide does not cause unreasonable adverse effects on the environment. 7
U.S.C. 136ac1, 5; see also 40 CFR
152.50.
Chlorpyrifos is currently undergoing registration review, which must be completed by October 1, 2022. 7 U.S.C.
136ag1Aiv. For information about the ongoing registration review process for chlorpyrifos, see https
www.regulations.gov/docket/EPA-HQOPP-2008-0850.
IV. FFDCA Petition and Related Litigation A. 2007 FFDCA Petition In 2006, EPA issued the Registration Eligibility Decision RED for chlorpyrifos, which concluded that chlorpyrifos was eligible for reregistration as it continued to meet the FIFRA standard for registration. In September 2007, PANNA and NRDC
submitted to EPA a petition the Petition seeking revocation of all chlorpyrifos tolerances under FFDCA
section 408 and cancellation of all chlorpyrifos pesticide product registrations under FIFRA. Ref. 1. That petition raised several claims regarding EPAs 2006 FIFRA reregistration decision for chlorpyrifos and the active registrations in support of the request for tolerance revocations and product cancellations. Those claims are described in detail in EPAs earlier order denying the petition 82 FR 16581, April 5, 2017 FRL996077.
B. Agency Responses and 2017 Order Denying Petition On March 29, 2017, EPA denied the Petition in full 82 FR 16581, April 5, 2017 FRL996077. Prior to issuing that order, EPA provided the Petitioners with two interim responses on July 16, 2012 and July 15, 2014, which denied six of the Petitions claims. EPA made clear in both the 2012 and 2014
responses that, absent a request from Petitioners, EPAs denial of those six claims would not be made final until EPA finalized its response to the entire Petition. Petitioners made no such request, and EPA therefore finalized its response to those claims in the March 29, 2017 Denial Order.
As background, three of the Petitions claims all related to the same issue:
Whether the potential exists for chlorpyrifos to cause neurodevelopmental effects in children
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