Food Safety Amendments of 1989

Food Safety Amendments of 1989 - 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 (current law 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 or its 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. Provides for inclusion of inert ingredients in a pesticide chemical or its residue.

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 exceptions to such rule under certain circumstances.

Sets forth the following criteria for determining negligible risk: (1) for pesticide chemical residues 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 chemical residues which are likely to have an adverse human health effect at any level, the level at which the residue is not likely to cause or contribute to any additional adverse human health effects in the exposed population and will not cause or contribute to a risk of adverse human health effects, using conservative models, which exceeds a rate of one in a million.

Sets forth guidelines for determining dietary exposure to pesticide chemical 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.

Specifies that: (1) the tolerance level for a pesticide chemical residue in or on food shall be no higher than the Administrator determines is necessary for such chemical to have its intended effect; and (2) where tolerances or an exemption are revoked and the residue will unavoidably persist in the environment and contaminate food, the Administrator must establish a new tolerance not greater than that which permits the unavoidable levels to remain in the food.

Precludes, subject to exception, the establishment or continuation of a tolerance unless 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 shall be considered practical only if it can 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 determining whether to establish, modify, or revoke a tolerance for a pesticide chemical residue, 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 residue, 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, subject to exception, the Administrator from establishing or continuing in effect an exemption unless the Administrator determines that there is a method for detecting and measuring the levels of such chemical or residue and that such method is the best available practical method.

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 for an active or an inert ingredient, or both, 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 Administrator's options 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, subject to exception. 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).

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 shall be considered revoked, subject to exception; 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. 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.

Directs the Secretary of Health and Human Services to conduct surveillance and compliance sampling of raw agricultural commodities and processed foods for pesticide chemical residues.

Directs the Administrator to require fees sufficient to provide, equip, and maintain an adequate service for the performance of the Administrator's functions under these provisions.

Directs the Administrator to evaluate each pesticide chemical residue which is required to have a tolerance or an exemption to determine whether it exceeds the negligible risk standard, requiring the submission of data if necessary in order to make the determination. Lists actions the Administrator must take if the standard is exceeded, including: (1) requiring the submission of data supporting continuation of the tolerance or exemption; and (2) lowering one or more tolerances or revoking tolerances or exemptions. Allows the Administrator, if the risk is not significantly greater than the negligible risk standard, to issue a notice with specified contents in the Federal Register. Requires, within two years of the notice: (1) submission of data regarding the lowest residue level required to accomplish the intended effect; (2) a method for measuring levels of residue which meets certain requirements; (3) lowering of the risk under each tolerance to meet the standard; and (4) revocation of an exemption and establishment of one or more tolerances so as to meet the standard. Requires that, within four years of the notice, the risk meet the standard. Sets forth the consequences of failing to meet these deadlines. Provides for administrative and judicial review.

Revises the negligible risk standard, effective six years after enactment of this Act, to consider the risk of the residue in question combined with the risk of all other pesticide chemical residues usually used on the same raw agricultural commodity or processed food. Directs the Administrator, within one year of the revision, to revoke or modify all tolerances which do not meet the new standard.

Directs the Administrator to review tolerances and exemptions in effect on the date of enactment of this Act and to take actions as required by this Act. Provides for administrative and judicial review.

Directs the Administrator to publish: (1) a list of inert ingredients which are safe, which are required to have a tolerance, or which are required to be included in the tolerance for an active ingredient; and (2) an order requiring, by deadlines specified in the order, the submission of necessary data, concerning inert ingredients which are not on the safe list, to establish a tolerance. Requires that, if deadlines in the order are not met, the ingredient be considered unsafe, subject to exception. Provides for administrative and judicial review.

Declares that pesticide chemicals or chemical residues which do not have tolerances or exemptions before the date of enactment of this Act because they are generally recognized as safe shall not be considered unsafe solely because they do not have a tolerance or exemption.

Requires the Administrator, within one year of enactment, to establish deadlines for the submission of necessary 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.

Directs the Administrator to: (1) determine, for each method of measuring levels of certain residues, whether the requirements of this Act relating to practical methods of analysis have been met; and (2) publish a notice identifying methods which do not meet the requirements. Declares that, if any method does not meet the requirements within three years of the publication, any tolerance or exemption for the residue subject to the method shall be considered revoked.