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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Rules and Regulations than a continuation of and finalization of the Agencys proposal in 2015 to revoke chlorpyrifos tolerances.
In this final rule, EPA is revoking all tolerances for residues of chlorpyrifos contained in 40 CFR 180.342. This includes tolerances for residues of chlorpyrifos on specific food and feed commodities 180.342a1; on all food commodities treated in food handling and food service establishments in accordance with prescribed conditions 180.342a2 and a3; and on specific commodities when used under regional registrations 180.342c.
EPA finds that, taking into consideration the currently available information and the currently registered uses of chlorpyrifos, EPA cannot make a safety finding to support leaving the current tolerances for residues of chlorpyrifos in place, as required under the FFDCA section 408b2. 21 U.S.C.
346ab2. As described in greater detail below, the Agencys analysis indicates that aggregate exposures i.e., exposures from food, drinking water, and residential exposures, which stem from currently registered uses, exceed safe levels, when relying on the wellestablished 10% red blood cell acetylcholinesterase RBC AChE
inhibition as an endpoint for risk assessment and including the statutory tenfold 10X margin of safety to account for uncertainties related to the potential for neurodevelopmental effects to infants, children, and pregnant women. Accordingly, the Agency is therefore revoking all tolerances because given the currently registered uses of chlorpyrifos, EPA cannot determine that there is a reasonable certainty that no harm will result from aggregate exposure to residues, including all anticipated dietary food and drinking water exposures and all other exposures for which there is reliable information.

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B. What is the Agencys authority for taking this action?
EPA is taking this action pursuant to the authority in FFDCA sections 408b1A, 408b2A, and 408d4Ai. 21 U.S.C. 346ab1A, b2A, d4Ai.
C. Overview of Final Rule When assessing pesticides, EPA
performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA, see https www.epa.gov/lawsregulations/summary-federal-food-drugand-cosmetic-act, and for a complete description of the risk assessment
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process, see https www.epa.gov/
pesticide-science-and-assessingpesticide-risks/overview-riskassessment-pesticide-program and https www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/epas-riskassessment-process-tolerancereassessment.
In general, to assess the risk of a pesticide tolerance, EPA combines information on pesticide toxicity with information regarding the route, magnitude, and duration of exposure to the pesticide. The risk assessment process involves four distinct steps: 1
Identification of the toxicological hazards posed by a pesticide; 2
Determination of the exposure level of concern for humans, which includes choosing a point of departure PoD that reflects the adverse health endpoint that is most sensitive to the pesticide, as well as uncertainty factors; 3
Estimation of human exposure to the pesticide through all applicable routes;
and 4 Characterization of human risk based on comparison of the estimated human exposure to the level of concern.
For tolerances, if aggregate exposure to humans is greater than the Agencys determined level of concern, the Agencys determination is the tolerances are not safe.
The following provides a brief roadmap of the Units in this rule.
Unit III. contains an overview of the statutory background, including the safety standard in FFDCA, and the registration standard under FIFRA.
FFDCA provides the statutory basis for evaluating tolerances and directs the Agency to revoke tolerances that are not safe.
Unit IV. provides an overview of the FFDCA petition that requested that EPA revoke chlorpyrifos tolerances on the grounds that those tolerances were not safe under the FFDCA. While that petition raised numerous issues, the primary scientific challenge to the chlorpyrifos tolerances that was before the Ninth Circuit related to whether EPA had selected the correct PoD for assessing risk. While EPAs PoD was based on inhibition of the enzyme acetylcholinesterase AChE, petitioners asserted that the most sensitive health endpoint was neurodevelopmental outcomes from exposure to chlorpyrifos.
A summary of that petition, EPAs response to that petition, and the subsequent litigation and Ninth Circuits order directing EPA to revoke or modify the chlorpyrifos tolerances is included in this section.
Unit V. provides an overview of the regulatory background for chlorpyrifos, including the numerous human health risk assessments EPA has conducted
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and FIFRA Scientific Advisory Panels SAPs that were convened to discuss the complex scientific issues associated with chlorpyrifos.
Units VI. through VIII. summarizes EPAs risk assessment, which reflect the four-step process described above.
Unit VI, which focuses on the hazard assessment of chlorpyrifos, combines the first two steps to provide a full picture of how EPA conducts its hazard assessment. After describing the process generally, this unit discusses EPAs analysis of the hazards posed by chlorpyrifos, including a discussion of the available data on AChE inhibition and the potential for neurodevelopmental outcomes in the young. Unit VI. also discusses the Agencys process for determining the endpoint on which to regulate chlorpyrifos exposure and the rationale for basing the PoD analysis on 10%
AChE inhibition. Finally, this Unit includes a discussion of the FQPA
safety factor and the Agencys reasons for retaining the default 10X value.
Unit VII. describes EPAs exposure assessment for chlorpyrifos. The unit includes a description of the general approach for estimating exposures to pesticide residues in or on food and in drinking water, as well as exposures that come from non-occupational and non-dietary sources, also referred to as residential exposures. The unit walks through how EPA conducted those exposure assessments for chlorpyrifos, including a detailed discussion of the recent refinements to the drinking water analysis conducted by EPA for chlorpyrifos.
Unit VIII. describes the Agencys process for assessing aggregate risk based on the hazard discussed in Unit VI. and the exposure discussed in Unit VII. and provides the Agencys rationale and conclusions concerning the overall risks posed by chlorpyrifos based on the currently registered uses. Unit VIII.
concludes that the aggregate risks exceed the level of concern and therefore the chlorpyrifos tolerances must be revoked.
Units IX. and X. address procedural matters, international obligations, statutory and executive order review requirements, and the specific revisions that will be made to the Code of Federal Regulations with this final rule.
III. Statutory Background A. Federal Food, Drug, and Cosmetic Act FFDCA Tolerances A tolerance represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed
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