Food Safety Amendments of 1988

Food Safety Amendments of 1988 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to revise the definition of "pesticide chemical" by including pesticide chemical residues in processed foods, inert ingredients of pesticide chemicals, and substances resulting from the metabolism or degradation of a pesticide chemical.

Specifies that pesticide chemical residues in or on a raw agricultural commodity or processed food (defined as any food other than a raw agricultural commodity that has been subject to processing) and pesticide chemicals used in the production, storage, or transportation of processed food (currently, does not cover residues or apply to processed foods) are not food additives.

Specifies that pesticide chemical residues in processed food, if within the tolerances set under this Act, do not make the food "adulterated" within the meaning of the FDCA.

Establishes the general rule that any pesticide chemical residue in or on food, and any pesticide chemical added to food, requires either a tolerance or an exemption, and that the residue remaining on food must be within the tolerance limit or consistent with the exemption.

Specifies that: (1) pesticide chemical residues in or on processed food which do not have a separate tolerance are lawful if those residues have been removed to the extent possible in good manufacturing practice and are within the tolerance for the raw agricultural commodity from which the processed food was made; and (2) raw agricultural commodities and processed food that contain pesticide chemicals or their residues pursuant to such a tolerance or exemption shall not be considered adulterated.

Authorizes the Administrator of the Environmental Protection Agency to: (1) promulgate regulations that establish, modify or revoke tolerances either in response to a petition or on the Administrator's initiative; and (2) establish expiration dates for such tolerances.

Provides that a tolerance may be established for a pesticide chemical or pesticide chemical residue only if the risk to human health, including the health of identifiable population groups with special food consumption patterns, from dietary exposure to the chemical or residue is negligible. Revokes or modifies such tolerance if such risk is greater than negligible. Creates an exception to such rule under certain circumstances.

Sets forth the following criteria for determining negligible risk: (1) for pesticide chemicals which are not likely to have any adverse human health effect below an identifiable level, the level at which the chemical will not cause or contribute to any known or anticipated adverse human health effects (including an ample margin of safety); and (2) for pesticide chemicals for which there is no level at which such chemicals will not cause adverse human health effects, the level at which the chemical will not cause or contribute in the population exposed to such chemical to a cancer risk (using conservative models) which exceeds a rate of one in a million.

Sets forth guidelines for determining dietary exposure to pesticide chemicals or their residues. Directs the Administrator to: (1) take into account all dietary exposure to the chemical, including exposure under the proposed tolerance (or the tolerance in effect in the case of a petition to modify and revoke an existing tolerance), all other sources of dietary exposure (including drinking water) to the same chemical; and (2) consider the level of exposure based on the assumption that residues are on all authorized raw agricultural commodities and processed food at tolerance levels and exposure occurs for a lifetime, with specified exceptions.

Sets forth factors to consider when the Administrator is required by this Act to consider the benefits of a pesticide chemical, including the effect of the use of such chemical on the food supply, the availability of alternatives, the extent to which other pest control methods can be substituted for the chemicals, and costs and health risks. Directs the Administrator to: (1) publish the basis for his determination when acting on the tolerance petition; and (2) propose regulations within 90 days of enactment specifying how the analysis of benefits will be conducted, the data that will be relied upon, and the factors that will be considered.

Specifies that: (1) the tolerance level for a pesticide chemical applied to food shall be no higher than the Administrator determines is necessary for such chemical to have its intended effect; and (2) where such a chemical leaves no detectable residue, the Administrator shall establish a tolerance at the most sensitive limit of detection of the analytical method for detecting residues that the Administrator approves under this Act.

Precludes the establishment of a tolerance until the Administrator determines that there is a practical method for detecting and measuring residues. Specifies that such method must be the best available practical method and that it would be considered practical only if it could be performed by the Secretary of Health and Human Services on a routine basis with the personnel, equipment, and other resources available to the Secretary.

Sets forth factors to be considered by the Administrator in determing whether to establish, modify, or revoke a tolerance for a pesticide chemical, including: (1) the probable consumption of treated food by the population group which consumes the greatest amounts of the food or which is most sensitive to the chemical; (2) the cumulative effect of the chemical, taking into account related chemicals and non-dietary routes of exposure; and (3) safety factors that are appropriate for animal experiments.

Authorizes the Administrator to establish, modify, or revoke an exemption from the requirement for a tolerance in response to a petition or on the Administrator's own initiative. Specifies that an exemption may have an expiration date.

Authorizes an exemption to be established, or left in effect, only if the pesticide chemical residue presents no risk to human health, including the health of identifiable population groups with special food consumption patterns, from dietary exposure at any level of residue that could result from use of the chemical on food.

Directs the Administrator, in determining dietary exposure, to take into account: (1) all dietary exposure to the pesticide chemical, including exposure under the proposed exemption, all other tolerances or exemptions in effect for the same chemical, and all other sources of dietary exposure (including drinking water) to the same chemical; and (2) the maximum amount of residue that could reasonably be expected to occur if the instructions for use of the pesticide were not followed.

Prohibits the Administrator from establishing an exemption: (1) unless the Administrator determines that there is a practical method for detecting and measuring the levels of such chemical or residue and that such method is the best available practical method; and (2) for those inert ingredients of a pesticide chemical which are essential for an active ingredient to have its intended effect, causing or contributing to adverse biological effects in any organism which may have an adverse effect on human health, and meet any other requirement established by the Administrator.

Allows any person to file a petition for the issuance of a regulation that establishes, modifies, or revokes a tolerance, or establishes or revokes an exemption. Specifies the information and data that must be contained in a petition to establish a new tolerance or new exemption, including: (1) a summary of the scientific reports respecting the safety of, and exposure to, the pesticide chemical; and (2) a statement that the petitioner authorizes the publication of such summary by the Administrator.

Authorizes the Administrator to establish requirements for petitions to modify or revoke tolerances or exemptions.

Directs the Administrator to publish a notice of the filing of a complete petition within 30 days of such filing, announcing the availability of a complete description of the analytical methods for the detection and measurement of the pesticide chemical in food and including the summary required in the petition to establish a tolerance or exemption.

Specifies the actions that the Administrator may take after considering the petition and other available information, including publication of a final regulation approving or disapproving the petition, or proposing a regulation that is different from that requested in the petition. Makes a final regulation issued under this section effective upon the date of publication. Sets forth procedures for filing and considering objections to the final regulation.

Provides for judicial review for any person adversely affected (including a person without an economic interest) by the Administrator's decision. Specifies that such review would not operate to stay the Administrator's decision unless specifically ordered by the court.

Authorizes the Administrator to establish, modify, or revoke a tolerance or to establish or revoke an exemption on his own initiative. Requires the Administrator to issue a notice of any proposed rule and provide for at least a 30 day period for public comment on the proposed regulation (unless the public interest requires a shorter period or the Administrator is acting to revoke or suspend a tolerance or exemption).

Authorizes the Administrator to revoke an exemption, or to revoke or modify a tolerance, without following the required procedure if such action is necessary to prevent an imminent hazard. Directs the Administrator, in such case, to provide notice of the action and to hold a public hearing within five days of a request (which request was made within five days of the Administrator's action) for a hearing. Specifies that the effective date of the action shall not be delayed because of the hearing and the order may not be judicially reviewed until after the hearing or set aside while the order is being judicially reviewed.

Requires the Administrator to request additional data, or initiate an action to modify or revoke the exemption, if the data contained in a petition (including a petition submitted before the date of enactment) to establish a tolerance or exemption is inadequate to support the continuation of such tolerance or exemption.

Specifies that: (1) when the Administrator requires the submission of data, the Administrator shall publish an order in the Federal Register that establishes deadlines for the identification of the persons who will submit the data and the submission of necessary data and reports; (2) if such deadlines are not met, the tolerance or exemption would be automatically revoked (but allows the Administrator to delay the effective date of the revocation for up to 12 months for food containing residues which are within the tolerance or exemption or for such other period as necessary if extraordinary circumstances prevented the submission within the deadline); and (3) an order issued under this section shall be subject to administrative and judicial review.

Provides for the confidentiality of data contained in a petition (upon request of the petitioner) until publication of a regulation or order unless disclosure has been made previously, or is allowed under this Act or otherwise required by law. Specifies the persons to whom confidential data may be disclosed, including the Congress and certain U.S. employees and authorized contractors of the Administrator. Authorizes the Administrator to publish the informative summary required in the petition and other summaries of the data relating to the proposed or final regulation or order.

Sets forth procedures by which the public may obtain access to the health and safety data submitted or cited in support of a petition.

Sets forth conforming provisions with respect to actions on the registration of pesticide chemicals under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Requires the Administrator, within 90 days of the enactment of this Act, to establish deadlines (and publish such deadlines and related information in the Federal Register) for the submission of necessary health and safety data to establish tolerances for inert ingredients which do not have tolerances as of the date of the enactment of this Act and for which an exemption may not be established under the FDCA. Provides that if the deadlines are not met, the pesticide chemicals containing the inert ingredients shall be considered unsafe, except that the Administrator could delay the effective date of the determination under specified circumstances. Subjects the order of the Administrator requiring the submission of data to administrative and judicial review.

Requires the Administrator, within 90 days of enactment, to establish deadlines for the submission of necessary health and safety data to establish tolerances or exemptions for any pesticide chemicals which, on the date of enactment, do not have tolerances or exemptions because they are generally recognized as safe. Authorizes the Administrator to issue an order declaring such chemicals to be unsafe if such deadlines are not met. Provides for administrative and judicial review of such order. Specifies that such chemicals shall not be considered unsafe solely because they do not have a tolerance or exemption. Revises existing exemptions by requiring the Administrator, within 90 days of enactment, to establish deadlines for the submission of necessary health and safety data to establish tolerances or to continue the exemptions. Provides that if such deadlines are not met the exemptions would be automatically revoked. Authorizes the Administrator to delay the effective date of the revocation under specified conditions. Provides for administrative and judicial review.