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Food Quality Protection Act
FFDCA Amendments
On this page:
- Sec. 402 Definitions
- Sec. 404 Adulterated Food
- Sec. 405 Tolerances and Exemptions for Pesticide Chemical Residues
- Sec. 406 Authorization for Increased Monitoring
- Sec. 407 Alternative Enforcment
Defines "pesticide chemical" to be any substance that is a pesticide under FIFRA, including all active and inert ingredients. Definition in previous law was limited to pesticides used in the production of a raw agricultural commodity.
Defines "pesticide chemical residue" to be a residue of a pesticide chemical, its metabolites, and degradates in or on raw or processed foods.
Allows EPA to except a substance from these definitions, if its origin in food is primarily natural or resulting from non-pesticidal use; or if EPA determines, with DHHS, it is better regulated under other provisions of the FFDCA than sec.402(a)(2)(B) and sec.408.
Defines processed food as other than a RAC, including any RAC subject to processing such as canning cooking, freezing, dehydration, milling.
Defines adulterated food, in part, as food that has a pesticide chemical residue that does not meet the safety standard of FFDCA sec.408.
Sec.405 Tolerances and Exemptions for Pesticide Chemical Residues
(a) Requirements for Tolerance or Exemption
General Rule
Provides that any pesticide chemical residue on a food (RAC or processed) is unsafe unless a tolerance/exemption is in effect and the residue is within the limits of the tolerance.
Processed Food [flow through provisions]
Provides that if a tolerance /exemption is in effect for a pesticide chemical residue on a RAC, the tolerance/exemption applies to residues in any processed food made from the RAC, if the residues have been removed to the extent possible in good manufacturing process, and residues are not above the RAC tolerance. This eliminates the ready to eat requirement.
Residues of Degradation Products
Provides that metabolites/degradates of a pesticide chemical not covered by a tolerance will not render the food adulterated so long as the metabolite/degradates do not pose different or significantly greater risks by dietary exposure then the pesticide chemical; combined residues of the pesticide chemical, metabolites, and degradates would not exceed the tolerance if the tolerance had included them; and the tolerance/exemption is not limited to specifically named substances.
(b) Authority and Standard for Tolerance
Authority
Allows EPA to establish, modify, revoke a tolerance in response to petitions or on its own initiative.
Standard-General Rule
Allows EPA to establish or maintain a tolerance only if EPA determines it is safe. Requires EPA to modify/revoke a tolerance that is not safe.
Safe means that EPA has determined 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.
Standard-Tolerances for Eligible Pesticide Chemical Residues
Creates a category of tolerances for "eligible pesticide chemical residues". (A pesticide chemical residue meeting the safety standard is not an eligible pesticide chemical residue.)
An "eligible pesticide chemical residue" is one which has non-threshold effects; the lifetime risk is appropriately assessed quantitatively; and for any threshold effect, the aggregate exposure is safe.
"Eligible" tolerances may remain in effect if :
- use protects consumers from adverse health effects posing a greater risk, or
- use is necessary to avoid significant disruption of domestic production of an adequate, wholesome, and economic food supply
and if
- the yearly risk from aggregate exposure to non-threshold effects is not greater than 10X the yearly risk that would meet the safety standard; and
- lifetime risk is not greater than 2X lifetime risk that would meet the safety standard.
- such tolerance meets the requirements in the infants and children provision.
Requires EPA to review an "eligible" tolerance five years after an initial determination to maintain/modify an "eligible" tolerance, and to determine if these conditions still exist. The review process must provide opportunity for notice and comment. If these conditions no longer exist, EPA must modify/revoke the tolerance within 180 days.
Standard-Exposure of Infants and Children
Requires EPA, in establishing, modifying, revoking a tolerance/exemption, to assess risk based on:
- available information on consumption by infants/children;
- available information on special susceptibility of infants/children, including neurological differences and effects of in utero exposure;
- available information on cumulative effects on infants/children of pesticide chemicals and other substances with common mechanisms of toxicity.
Requires EPA to ensure there is a reasonable certainty that no harm to infants/children will result from aggregate exposure and to publish specific determinations regarding safety for infants/children.
Requires DHHS and USDA, in consultation with EPA, to conduct dietary exposure surveys among infants/children.
Requires EPA to apply an additional tenfold safety factor for threshold effects if complete, reliable data are not available to assess pre or postnatal toxicity to infants/children. (If data are complete, acceptable and do not indicate potential pre or postnatal effects of concern, the additional tenfold safety factor would not be applied.)
Standard-Factors
In establishing, modifying, maintaining, revoking tolerances/exemptions EPA must consider, among other relevant factors:
- validity, completeness,reliability of available data from studies;
- nature of toxic effect shown by studies;
- available information on relationship of study results to human risk;
- available information on dietary consumption (consumers and major identifiable subgroups);
- available information on cumulative effects of residues and other substances with common mechanism of toxicity;
- available information on aggregate exposure (dietary and other non-occupational sources including drinking water);
- available information on variability of sensitivities of major identifiable subgroups;
- information on endocrine disruption effects;
- appropriate safety factors.
Standard-Data and Information Regarding Anticipated and Actual Residue Levels
Allows EPA to consider available information on anticipated/actual residue levels. If such data are used to support a tolerance, data must be provided 5 years after to confirm that the original data still accurately reflect current residue levels. If data are not provided, or do not confirm the original data, EPA must modify/revoke the tolerance within 180 days. After the initial 5 year reevaluation, EPA thereafter may require additional confirmation as appropriate.
Standard-Percent of Food Actually Treated
Allows EPA, when assessing chronic dietary risk, to consider percent-food-treated information if:
- data are reliable, valid basis for showing percent food likely to contain pesticide chemical residue;
- exposure estimate does not understate exposure for any significant subpopulation;
- available data on pesticide use and food consumption in a particular area do not show that population to be exposed dietarily above EPA estimate;
- EPA periodically reevaluates the anticipated dietary exposure estimate.
Standard-Detection Methods
Requires EPA to determine in consultation with DHHS that a practical method of detection exists before establishing/modifying a tolerance.
Standard-International Standards
Requires EPA to consider adopting a Codex MRL when establishing a tolerance. If EPA does not propose to adopt the Codex MRL, EPA must publish a notice for public comment explaining why.
(c) Authority and Standard for Exemptions
Provides similar authority and standard for exemptions as for tolerances.
(d) Petition for Tolerance or Exemption
Petitions and Petitioners
Allows any person to petition EPA to establish, modify, revoke a tolerance/exemption.
Petition Contents
Provides that petitions be supported by data and information specified by EPA in regulations including:
- informative summary which may be published;
- identity of the pesticide chemical;
- use pattern data;
- full reports of safety and exposure tests/investigations;
- practical method of detection (or why it is not needed for an exemption);
- proposed tolerance level;
- reports of processing investigations, if for a processed food;
- information needed for specific safety determination for infants/children;
- information needed to tell if pesticide chemical may have endocrine disruption effects;
- information about exposure from other tolerances/exemptions;
- practical removal methods for any residue exceeding proposed tolerance;
- anything else.
Notice
Requires EPA to publish a notice of filing within 30 days of determining that a petition meets these requirements for information/data. The notice must contain the informative summary and announce the availability of a description of the analytical methods or petitioners explanation why a method is not needed.
Actions by the Administrator
Requires EPA, after considering a petition and any other available information, to either issue a final rule (which may vary from the petition) to establish, modify, revoke a tolerance/exemption without further notice and comment, issue a proposed regulation, or deny the petition.
Requires EPA to give priority to petitions that appear to pose signficantly lower risk from dietary exposure.
Requires EPA to act within 1 year on a complete petition which presents a lower risk than an "eligible" tolerance. Requires EPA, within 180 days of establishing such a "safer" tolerance, to determine whether the "eligible" tolerance still meets the necessary conditions. If not, EPA must modify/revoke the "eligible" tolerance within 180 days of the determination.
(e) Action on Administrators Own Initiative
General Rule and Notice
Allows EPA to establish, modify, suspend, revoke, a tolerance/exemption on its own initiative and to establish general process/requirements to implement this section. EPA must propose such a rule for not less than 60 days comment before issuing a final rule, unless for good cause it would be in the public interest to provide a shorter comment period.
(f) Special Data Requirements
Requires EPA to use its data call-in authority under FIFRA to require registrants with products associated with a tolerance/exemption or its authority under TSCA sec.4 to provide data/information needed to maintain a tolerance/exemption.
Alternatively, if data could not be obtained under FIFRA/TSCA authorities, EPA may publish an order in the Federal Register, after 60 days comment, requiring interested persons to submit notice of who will provide the needed data and establishing dates for submission of notice and data.
Allows EPA to correct errors in such orders and to require data on endocrine disruption effects.
If data required are not submitted by time specified in notice, rule or order, EPA may by order modify/revoke the tolerance/exemption. The only material issue for review of an order shall be whether a required submission was timely submitted.
(g)
Effective Date, Objections, Hearings, and
Administrative Review
Regulations/orders establishing, modifying, suspending, revoking tolerances/exemptions are effective on publication unless otherwise specified. EPA may stay effectiveness if objections are filed.
Allows any person to file objections, particularly specifying provisions deemed objectionable and reasonable grounds therefor.
Allows any objector to request a public evidentiary hearing. Requires EPA to hold a hearing if and to the extent EPA determines a hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections. Allows hearing officer to issue subpoenas to compel testimony or production of documents.
Requires EPA to issue an order, as soon as practicable, stating action on each objection and setting forth any change to the regulation/order.
(h) Judicial Review
In the case of controversy as to the validity of any regulation issued under FFDCA sec.408(e)(1)(C) - general regulations,(f)(1)(C) - data call-in orders, or (g)(2)(C) - orders following a hearing, allows any person adversely affected to seek judicial review in the US Court of Appeals. The Courts judgment shall be final, subject to review by the Supreme Court. Unless specifically ordered, judicial review will not stay a regulation. An issue that is or could be reviewed under this subsection cannot be judicially reviewed under any other law.
(i) Confidentiality of Data
Grants confidential treatment, exclusive use, and data compensation rights to data submitted under FFDCA sec.408/409 to the same extent provided by FIFRA.
(j) Status of Previously Issued Regulations
Regulations affecting pesticide chemical residues issued under FFDCA sec.406 and regulations establishing tolerances for pesticide chemical residues under FFDCA sec.409 before enactment of the Food Quality Protection Act (FQPA) are deemed to be issued under this new section and are subject to modification, revocation, and reassessment. Regulations establishing tolerances/exemptions under FFDCA sec.408 before enactment of the FQPA remain in effect unless modified/revoked and are subject to reassessment.
(k) Transitional Provision
Substances regarded as GRAS on the day prior to enactment, shall be treated as exempt. Requires EPA to indicate which substances these are by regulation. These GRAS exemptions may be modified or revoked.
(l) Harmonization with Action under Other Laws
Coordination with FIFRA (106)
Requires EPA to coordinate tolerance revocations or suspensions with FIFRA cancellations/suspensions to the extent practicable and consistent with tolerance reassessment deadlines.
Revocation of Tolerance or Exemption Following Cancellation of Associated Registrations
If EPA cancels a pesticide registration in whole or in part for dietary risk concerns or modifies a registration to prohibit a use for such concerns, EPA must revoke associated tolerances/exemptions no later than 180 days after the cancellation is effective or the use becomes unlawful, whichever is later. These actions will be treated as actions on EPAs own initiative.
Suspension of Tolerance or Exemption Following Suspension of Associated Registrations
Provides similar authority to suspend tolerances/exemptions when registrations are suspended for dietary risk concerns. Suspensions become effective no later than 60 days after suspension of use becomes effective. Suspension of tolerances/exemptions lasts as long as the use suspension and must be rescinded if the use is left in effect.
Tolerances for Unavoidable Residues
Allows EPA to establish tolerances for residues of pesticides suspended or cancelled prior to enactment of the FQPA that unavoidably persist in the environment, taking into account the factors to be considered in setting a tolerance and the unavoidability of the residue. EPA must review such tolerances periodically and modify them so they allow no greater level that is unavoidable.
Pesticide Residues Resulting from Lawful Application of Pesticide
Specifies that food with pesticide chemical residues for which a tolerance/exemption has been revoked, suspended, modified, will not be automatically deemed unsafe (adulterated), if residues are the result of legal use at the time and do not exceed the previously authorized level, unless EPA determines consumption of legally treated food will pose an unreasonable dietary risk during its likely availability in commerce.
Tolerances for Use of Pesticides under an Emergency Exemption
Requires EPA to establish a tolerance/exemption if it grants an emergency exemption. Such tolerance may be established without notice and comment, but must have an expiration date. EPA must promulgate regulations within 365 days of enactment which will govern establishment of emergency exemption tolerances/exemptions. These regulations must be consistent with the FFDCA sec.408 safety standard and FIFRA sec.18.
(m) Fees
Requires EPA to establish a tolerance fee system by regulation that will be sufficient over a reasonable period of time to provide, equip, maintain adequate service for performing its tolerance functions.
Performance includes:
- acceptance of a petition for filing;
- establishing, modifying, maintaining,revoking tolerances/exemptions;
- acceptance for filing of objections;
- certification/filing in court of proceedings transcript/record.
EPA may grant fee waivers/refunds when, in EPAs judgment, it is equitable and not contrary to the purposes of this subsection.
Tolerance fees are to be placed in the Reregistration and Expedited Processing Funds, and shall be available without fiscal year limitation.
(n) National Uniformity of Tolerances
Qualifying Pesticide Chemical Residue; Qualifying Federal Determination; Notice
Except as the result of a new petition process, no state or political subdivision can establish/enforce a regulatory limit for a pesticide chemical residue on food different than the level established by the "Qualifying Federal Determination".
This term means a tolerance/exemption for a pesticide chemical residue whose first use was approved under FIFRA on or after April 25, 1985, with a complete data base or was reregistered on or after enactment of the Food Quality Protection Act. Such a tolerance/exemption must be:
- issued after enactment of the FQPA and meet the safety standard; or
- if issued prior to enactment of the FQPA, remaining in effect or deemed issued under the new section 408 or considered to be exempt; and determined by EPA to meet the safety standard. This determination can only be made by issuing a rule after 30 day comment on a proposed rule.
In other words, states are preempted only with regard to tolerances/exemptions for pesticide chemicals that have been reassessed against the new safety standard or initially assessed against that standard and found to meet it, after opportunity for notice and comment as appropriate. Preemption does not apply to tolerances for "eligible" pesticides.
State Authority; Petition Procedure; Urgent Petition Procedure
Even with regard to these tolerances, a state may still petition EPA to authorize a different regulatory limit. Such a petition must provide scientific data on the pesticide chemical residue, consumption within the state, and human exposure within the state. EPA may, by order, grant the authorization if it determines there are compelling local conditions, and it would not cause any food to violate federal law. Alternatively, EPA may treat such a state petition as a petition to modify or revoke a tolerance/exemption.
If a state petition demonstrates a significant public health threat from acute exposure, it must be considered urgent and EPA must act within 30 days of receipt to grant/deny the petition. Absent EPA action in 30 days, a state may establish a temporary regulatory limit.
Residues from Lawful Application
States/political subdivisions may not enforce any regulatory limit on lawfully treated food, if at the time of application of the pesticide, sale of the food with such residue level was legal unless a state demonstrates that consumption will pose an unreasonable dietary risk.
Savings
Nothing in FFDCA preempts states/political subdivisions from requiring food containing a pesticide chemical residue to bear or be subject of a warning or other statement related to the presence of the pesticide chemical residue.
(o) Consumer Right to Know
Within 2 years of enactment, EPA must, in consultation with USDA and DHHS, publish an easy to understand document and distribute it to large retail grocers. The document must:
- discuss risks/benefits of pesticides in foods;
- list tolerances set based on an alternative standard that meets strict conditions set in the law and associated foods;
- recommend ways to reduce dietary exposure to pesticides consistent with healthy diet, including reasonabe substitutes for those foods associated with these tolerances.
This document would be re-published if tolerances are issued under this alternative standard.
(p) Estrogenic Substances Screening Program
Development; Implementation
Requires EPA, in consultation with DHHS, to develop a screening program within 2 years to determine if certain substances may have endocrine disrupting effects.
Requires EPA to implement the screening program within 3 years, after review by the SAP or SAB.
Substances;Exemption
Requires EPA to provide for testing of all pesticide chemicals and any other substance that may have an effect cumulative to that of a pesticide chemical, if a substantial population may be exposed.
Biologic and other substances may be exempted if they are not anticipated to produce an endocrine disrupting effect.
Collection of Information; Agency Action
Authorizes EPA to require testing by registrants, manufacturers, importers by order and submission of data within a reasonable time, minimizing duplication of testing and developing procedures for fair/equitable cost sharing and for handling CBI.
If a registrant fails to comply with such a test order, EPA shall issue a notice of intent to suspend which will be final after 30 days unless the registrant has fully complied or requests a hearing. Compliance with the order is the only matter for resolution at the hearing.
Any other person who fails to comply will be subject to TSCA sec.16 penalties and sanctions.
EPA must take appropriate action for any substance that is found to have an endocrine effect on humans.
Report to Congress
Within 4 years, EPA must report to Congress on results of the screening program, recommendations for further testing, and further action.
(q) Schedule for Review
Requires EPA to review tolerances/exemptions for all pesticide chemical residues in effect on the day of enactment as expeditiously as possible:
- 33% in 3 years,
- 66% in 6 years,
- 100% in 10 years.
EPA must determine whether tolerances/exemptions meet the safety standard and issue regulations by the deadlines modifying/revoking those which dont.
EPA must give priority to those which appear to pose greatest risk to public health and must publish a schedule within 12 months of enactment. Failure to take final action by the times established in the schedule is judicially reviewable.
(r) Temporary Tolerance or Exemption
Allows EPA to establish a temporary tolerance/exemption for EUPs.
(s) Savings Clause
Nothing in the new section 408 amends TSCA/FIFRA.
Sec. 406 Authorization for Increased Monitoring
Authorizes $12 Million in aggregate for 1997-1999 for increased food monitoring by DHHS.
Sec. 407 Alternative Enforcment
Persons who introduce adulterated food into interstate commerce are liable to civil penalties of $50,000 for an individual, $250,000 for any other person, not to exceed $500,000 in a single proceeding. Farmers are not subject to this penalty.
If DHHS assesses a civil penalty, it may not use its criminal authorities or seizure/injunction authorities.