Section
405
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Sets forth requirements relating to tolerances and exemptions from tolerances for pesticide chemical residues in food, including residues of degradation products, which allow the presence in processed food at the tolerance applicable to the raw agricultural commodity from which the processed food is made if the pesticide chemical was used in or on the raw agricultural commodity in conformity with FDCA provisions governing such tolerances and residue in or on the commodity has been removed to the extent possible in good manufacturing practice. Allows the Administrator to establish or leave in effect a tolerance (or exemption from a tolerance) for a pesticide chemical residue only upon a determination that the tolerance (or exemption) is safe, defined to mean that there is a reasonable certainty that no harm will result from aggregate exposure to the residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. Creates a separate category of other pesticide chemical residues: (1) which do not meet this standard; (2) for which, under certain conditions, tolerances will be allowed to remain in effect or be modified; and (3) with respect to which the Administrator is unable to identify an exposure level at which the residue will not cause or contribute to a known or anticipated harm to human health ("nonthreshold effect"), but which presents a lifetime risk of such effect appropriately assessed by quantitative risk assessment. Describes these conditions as follows: (1) use of the pesticide chemical protects consumers from adverse health effects that pose a risk greater than that posed by the pesticide exposure or is necessary to avoid a significant disruption in the domestic food supply; (2) the yearly risk associated with the nonthreshold effect from aggregate exposure does not exceed ten times the yearly risk allowed under the general standard of safety; and (3) the tolerance is limited to ensure that lifetime risk associated with the nonthreshold effect from aggregate exposure is not greater than twice the lifetime risk allowed under the general standard. Requires a review of tolerance determinations made according to these procedures five years after the determination and thereafter as deemed appropriate. Requires the Administrator, in taking actions regarding a tolerance or exemption, to: (1) assess the risk of the residue based on available information about infants' and children's consumption patterns, their special susceptibility, and cumulative effects; and (2) ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the residue and publish a specific determination regarding its safety. Requires the Secretaries of HHS and of Agriculture to document dietary exposure of infants and children to pesticides. Requires, for infants and children, the application in the case of "threshold effects" (effects for which an exposure level is identifiable at which the residue will not cause or contribute to a known or anticipated harm) of an additional ten-fold safety margin for the residue and other sources of exposure. Allows use of a different margin only if it will be safe for infants and children. Sets forth factors to be considered in tolerance decisions, requirements regarding data on anticipated or actual residue levels, and guidelines concerning the percentage of food actually treated. Imposes requirements, in establishment and modification of tolerances, for practical residue detection and measurement methods and consideration of international standards set by the Codex Alimentarius Commission. Sets forth procedures for establishing, modifying, or revoking an exemption from a tolerance requirement that conform with the standards of safety described above. Revises requirements regarding petitions by any person (under current law, any registrant or applicant for registration under FIFRA) for proposing issuance of regulations concerning actions on tolerances or exemptions. Requires the Administrator to give priority to petitions concerning tolerances for a residue that appears to pose a significantly lower health risk than others with tolerances in effect for the same uses. Revises procedures for rulemaking on the Administrator's initiative. Establishes procedures for requiring submission of additional data where the Administrator determines this is necessary to continue a tolerance or exemption, including requiring data pertaining to possible estrogenic or other endocrine effects. Prohibits issuance of a final rule that revokes, modifies, or suspends a tolerance or exemption until the Administrator has taken any necessary action under FIFRA with respect to the registration of the pesticide involved. Requires the Administrator, where a pesticide is labeled for use on a particular food, to: (1) revoke any tolerance or exemption that allows the presence of a particular chemical or its residue in or on such food if the Administrator cancels the registration of each pesticide that contains the chemical or modifies it to prohibit the pesticide's use in connection with such food; and (2) suspend any such tolerance or exemption upon the suspension of the use of each pesticide that contains the chemical. Provides for: (1) tolerances for unavoidable residues in the case of a residue of a canceled or suspended pesticide chemical that will unavoidably persist in the environment and be present in or on a food; and (2) residues resulting from an application which was lawful at the time of application but with respect to which the tolerance or exemption has since been revoked, suspended, or modified. Requires the Administrator, where an exemption for a pesticide chemical is granted under FIFRA to a Federal or State agency under emergency conditions, to establish a tolerance or exemption for the chemical residue to expire on a definite date. Allows this without provision of notice or a period for comment and requires promulgation of rules governing this establishment procedure. Requires such rules to be consistent with FDCA safety standards (as revised by this Act) and FIFRA exemption provisions. Requires the deposit of fees collected to administer the tolerances and exemptions provisions in the Reregistration and Expedited Processing Fund (so named by title V of this Act). Prohibits, subject to exception, a State from enforcing any limit on a qualifying pesticide chemical residue (as defined in this Act) in or on any food which is not identical to Federal requirements. Establishes petition procedures, including urgent petition procedures where a significant public health threat is posed by a pesticide residue level, to authorize States to set different regulatory limits despite these prohibitions. Prohibits a State, absent an unreasonable dietary risk, from enforcing a limit on the level of residues in any food if the sale of such food containing such residue level was lawful at the time of application of the pesticide. Excludes from these preemption provisions requirements regarding warnings or other statements concerning the presence of pesticide residues in or on food. Requires the Administrator, in consultation with the Secretaries of Agriculture and of HHS, to annually publish (in a format understandable to a lay person) and distribute to large retail grocers for public display certain information concerning pesticide residues in or on food, including risk-benefit discussions and dietary recommendations. Requires the Administrator, in consultation with the HHS Secretary, to: (1) develop a screening program (including testing, data collection, and sanctions for failure to submit information) to determine whether certain substances may have an effect in humans similar to one produced by naturally occurring estrogen or another designated endocrine effect; and (2) if a substance is found to have such effect, take action necessary to protect the public health. Directs the Administrator to review expeditiously (for compliance with the standards instituted by this Act) tolerances and exemptions in effect before enactment of this Act.