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Food Quality Protection Act of 1996
FIFRA Amendments
TITLE I--SUSPENSION-APPLICATORS
- Sec. 102 Suspension
- Sec. 103 Tolerance Reevaluation as Part of Reregistration
- Sec. 104 Scientific Advisory Panel
- Sec. l05 Nitrogen Stabilizer
- Sec. l06 Periodic Registration Review
- Sec. 120 Training for Maintenance Applicators and Service Technicians
- Sec. 2l0 Minor Crop Protection
- Sec. 22l Antimicrobial Pesticide Definitions
- Sec. 222 Federal and State Data Coordination
- Sec. 223 Label and Labelling
- Sec. 224 Registration Requirements for Antimicrobial Pesticides
- Sec. 225 Disposal of Household, Industrial, or Institutional Antimicrobial Products
- Sec. 230 Public Health Pesticide Definitions
- Sec. 23l Registration
- Sec. 232 Reregistration
- Sec. 233/234 Cancellation/Views of the Secretary of HHS
- Sec. 235 Authority of Administrator in Issuing Regulations
- Sec. 236 Identification of Pests
- Sec. 237 Public Health Data
- Sec. 250 Expedited Registration of Reduced Risk Pesticides
- Sec. 30l Data Collection to Assure the Health of Infants and Children
- Sec. 302 Collection of Pesticide Use Information
- Sec. 303 IPM
- Sec. 304 Coordination of Cancellation
- Sec. 305 Pesticide Use Information Study
Allows EPA to suspend a pesticide registration in an emergency situation without simultaneously issuing a notice of intent to cancel. A notice of intent to cancel would need to be issued within 90 days or the suspension would automatically expire.
Sec. l03 Tolerance Reevaluation as Part of Reregistration
Specifies that tolerances and exemptions from tolerances must be reassessed as part of reregistration to determine whether they meet the requirements of the FFDCA. These reassessments must be made as soon as EPA has sufficient information to assess dietary risk, but no later than it makes product reregistration decisions (14 months after a RED is issued). These determinations for existing tolerances and exemptions and the need for any additional tolerances or exemptions must be published in the Federal Register and appropriate regulatory action begun promptly.
Sec. 104 Scientific Advisory Panel
Establishes a Science Review Board of 60 scientists to assist the Scientific Advisory Panel in its work.
Defines those nitrogen stabilizers which are pesticides; excludes dicyandiamide, ammonium thiosulfate, and certain substances or mixtures of substances from the definition; allows marketing of nitrogen stabilizer/fertilizer mixtures without individual product registration (and subject to certain other exemptions) so long as various enumerated criteria are met.
Sec. l06 Periodic Registration Review
Permits continued sale and use of existing stocks of suspended or canceled pesticides under conditions determined by the Administrator to be consistent with FIFRA.
Requires EPA to periodically review registrations of pesticides and to establish by regulation a procedure for periodic review. The goal is to accomplish a periodic review of a pesticide's registration every l5 years.
Registrations can be canceled as a result of periodic review only through the cancellation procedures and substantive requirements of FIFRA sec.6. EPA will use its data call-in authority to require needed data; current data submission, compensation and formulator exemption provisions apply to such data.
Removes the existing provision for cancellation after 5 years.
Sec. 120 Training for Maintenance Applicators and Service Technicians
Creates two new types of pesticide applicators: l) maintenance applicators - who use or supervise the use of structural or lawn care pesticides not classified for restricted use and 2) service technicians - who use or supervise use of pesticides (other than a ready to use consumer products pesticide) for structural pest control or lawn pest control on another's property for a fee. (neither of these terms include people who use antimicrobials, sanitizers, and disinfectants. In addition, maintenance applicators do not include government employees or people who use pesticides not classified as restricted use on non-commercial property.)
Authorizes states to establish minimum training requirements for these applicators; EPA's role on these minimum training requirements is to ensure that states understand these provisions.
Sec. 2l0 Minor Crop Protection
Defines Minor Use:
Use on less than 300,000 U.S. acres as determined by USDA; or
Use does not provide sufficient economic incentive to support registration, as determined by EPA, in consultation with USDA, based on information provided by applicant/registrant; and
- insufficient efficacious and available registered alternative pesticides; or
- alternatives pose greater risks; or
- minor use will significantly help manage pest resistance; or
- minor use will be a significant part of an IPM program.
Extends period for exclusive use of data for new pesticide active ingredients for one additional year for each 3 minor uses registered after enactment within the first 7 years of the exclusive use period, up to a total of 3 years. For existing pesticides, it affords 10 years of data compensation for addition of a new minor use.
Provides time extensions for development of minor use data until the final deadline for submission of data required for reregistration of other uses of the pesticide.
Allows EPA to waive data requirements for a minor use as long as the Administrator can determine the minor use's incremental riak and that the incremental risk would not present an unreasonable adverse effect.
Requires the Administrator to expeditiously review (within 12 months to the greatest extent practicable) applications that propose significant minor uses or solely for minor uses. Failure to review within this time period is not subject to judicial review.
Temporarily extends registrations for minor uses not being supported in reregistration until the last data submission deadline (in existence as of enactment) for the supported uses unless the absence of data causes human health or environmental concerns.
Permits registration of new pesticides for a minor use identical or substantial similar to a previously registered pesticide even if the previously registered pesticide is voluntarily cancelled while the new registration application is still pending approval unless the minor use may cause an unreasonable adverse effect to the environment.
Requires EPA to establish a minor use program to coordinate minor use activities and consult with growers; to prepare a public report within 3 years of passage of the FQPA.
Requires USDA to coordinate its minor use responsibilities, including the work of IR-4; the national pesticide resistance monitoring program; IPM research; grower consultation; assistance for minor use registrations, tolerances, and reregistrations.
Requires USDA, in consultation with EPA, to establish a grant program for minor use data development.
Establishes minor use pesticide data revolving fund in U.S. Treasury for deposit of fees paid to USDA for use of data developed through minor use data development grant program. In addition, money may be appropriated for this fund; $10M is authorized to be appropriated each fiscal year.
Sec. 22l Antimicrobial Pesticide Definitions
Defines antimicrobial pesticides as those which are exempt from or do not otherwise require a tolerance or food additive regulation and control growth of microbiological organisms or protect inanimate objects, industrial processes, water or other chemical substances from bacteria, viruses, fungi, protozoa, algae or slime. Excludes liquid chemical sterilants (and subordinate claims on such products) used on critical/semi-critical devices, as defined by FFDCA. (They are regulated by FDA.) Excludes wood preservatives and antifouling paints that make other or additional pesticidal claims; agricultural fungicides; and aquatic herbicides.
Sec. 222 Federal and State Data Coordination
Requires EPA, to the extent practicable, to coordinate data requirements, test protocols, timetables, and standards of review with Federal and State regulatory authorities to reduce burden and redundancies, and to establish a process to alleviate disparities in 1 year. EPA may enter into cooperative agreements with states for data coordination purposes. This section applies to all types of pesticides.
Allows antimicrobial pesticide product registrants, through a notification process, to modify labeling to include information not related to pesticidal claims/activity so long as it is not false or misleading or conflicting with required statements. Establishes a specific process for EPA to disapprove labeling modifications that are not acceptable within 30 days of receipt of notificiation.
Allows use of different precautionary statements for concentrates and use dilutions of products.
Sec. 224 Registration Requirements for Antimicrobial Pesticides
EPA must identify reforms to the registration process, consistent with risk associated with an antimicrobial pesticide and the type of review appropriate to evaluate the risks, to reduce review times for all types of registration actions. The goals for review of complete applications are:
- 540 days for a new antimicrobial active ingredient;
- 270 days for a new antimicrobial use of a registered active ingredient;
- 120 days for any other new antimicrobial product;
- 90 days for a "me-too" antimicrobial product;
- 90 days for an amendment to an antimicrobial product requiring no scientific review;
- 90 - 180 days for any other antimicrobial product amendment requiring scientific review.
Requires EPA, within 270 days after enactment, to propose regulations designed to implement the goals to the extent practicable:
- define use patterns,
- differentiate review types and conform review to risks/benefits presented by antimicrobials,
- maintain efficacy,
- implement reliable deadlines.
EPA shall solicit view of registrants and other affected parties to maximize the effectiveness of the rule development process.
Requires EPA to issue final regulations within 240 days after close of comment period; for any goal not met, explain why and future efforts to attain goal.
Instructs EPA, in issuing final regulations, to consider establishing a certification process for certain regulatory actions involving risks that can be responsibly managed; to consider a certification process by approved laboratories as an adjunct to the review process; and to use all appropriate, cost-effective review mechanisms, including expanding notification/non-notification procedures;revising review procedures; allocating appropriate resources; clarifying criteria for completeness of applications.
This will not impact 3(c)(3) deadlines.
Establishes alternate review periods which come into force if regulation is not effective in 630 days (2l months) and remain in force until regulation is effective:
- 2 years for a new antimicrobial active ingredient;
- 1 year for a new antimicrobial use of a registered active ingredient;
- 180 days for any other new antimicrobial product;
- 90 days for a "me-too" antimicrobial product;
- 90 days for an amendment to an antimicrobial product requiring no scientific review;
- 240 days for any other amendment to an antimicrobial product requiring scientific review.
Time periods for review of wood preservatives with antimicrobial claims will be the same as for an antimicrobial if data requirements are the same, consistent with the degree of risk posed by the product.
Requires EPA to notify an applicant by the final day of the review period of the Agency's decision, unless applicant and Agency both agree to a later date. Failure to notify is judicially reviewable. This notification requirement does not apply to expedited review (fast track) applications filed prior to 90 days after enactment of the Food Quality Protection Act (FQPA).
Requires EPA to submit annual reports to Congress by March l until review goals are met.
Sec. 225 Disposal of Household, Industrial, or Institutional Antimicrobial Products
Provides that household, industrial, or institutional antimicrobial products not regulated under the Solid Waste Disposal Act are not subject to the storage, disposal, transportation, container design, and residue removal provisions of FIFRA sec.19(a),(e)and (f),unless EPA determines such a product must be subject to such provisions to prevent unreasonable adverse effects.
Sec. 230 Public Health Pesticide Definitions
Amends the definition of unreasonable adverse effects on the environment by specifying that the risks and benefits of public health pesticides be considered separate from the risks and benefits of other pesticides. Requires EPA to weigh the risks of a public health pesticide against the health risk of the disease to be controlled.
Defines a public health pesticide as a minor use pesticide used predominantly in public health programs for vector control or other health protection uses, including viruses, bacteria, or other microorganisms (other than those on or in living man or other living animal).
Defines vector as an organism capable of transmitting an agent of human disease or producing human discomfort or injury, including mosquitoes, flies, fleas, cockroaches, other insects and ticks, mites, or rats.
Instructs the Agency in establishing data requirements to consider the need for public health and agricultural minor uses. As to all data requirements for pesticide uses, the Agency is to consider the pesticide's potential beneficial or adverse effects.
Allows EPA to exempt public health pesticides from reregistration fees if the Administrator, in consultation with DHHS, determines the economic return to the registrant from sales does not support registration/reregistration. Allows use of the Reregistration and Expedited Processing Fund to expedite review of a public health pesticide end use product.
Sec. 233/234 Cancellation/Views of the Secretary of HHS
Instructs DHHS to provide benefits and use information, if a public health use pesticide is subject to a cancellation notice and to be solicited to provide views on regulations for any public health pesticide before publication.
Sec. 235 Authority of Administrator in Issuing Regulations
Instructs EPA to take into account differences in various classes of pesticides, including public health pesticides.
Sec. 236 Identification of Pests
Instructs EPA, in coordination with USDA and DHHS to identify pests of public health significance and, with the Public Health Service, develop and implement programs to improve safe methods of controlling public health pests of importance.
If requested by a registrant of any other interested party, EPA shall consult with DHHS before suspending or cancelling a public health pesticide for failure to provide data or meet conditions of registration, or at the request of the registrant. EPA must prescribe form and contents of request.
EPA, in consultation with DHHS, shall determine if benefits of continued use are of such significance that DHHS should conduct the necessary studies to support registration. Authorizes extension of time under 3(c)(2)(B) for DHHS to submit data. DHHS may use funds appropriated under this section, the Public Health Service Act, or other appropriate authorities to conduct studies. Authorizes $12 million to be appropriated for 1997 and as necessary in future for this purpose.
Sec. 250 Expedited Registration of Reduced Risk Pesticides
Requires EPA to develop procedures and guidelines within 1 year, for the expedited review and to expedite the review of pesticides that reduce risk of pesticides to human health, nontarget organisms, ground and surface water, other valued environmental resources, or that would broaden adoption of IPM strategies. Within 30 days of receipt of an application requesting expedited review for these reasons, EPA will notify the applicant whether the application is complete.
Instructs USDA in consultation with EPA and DHHS, to conduct food consumption surveys that will provide adequate data on consumption patterns of infants/children.
Instructs USDA, in cooperation with EPA and DHHS, to provide for improved collection of pesticide residue data, by standardized reporting methods, for foods most consumed by infants/children.
Sec. 302 Collection of Pesticide Use Information
Instructs USDA to collect use data for major crops and crops of dietary significance, consulting with EPA in the design of surveys and providing aggregate results to EPA.
Instructs USDA to implement IPM Research/Education programs and USDA/EPA to make IPM information widely available and promote its adoption through their regulatory policies and activities.
Sec. 304 Coordination of Cancellation
Coordinates FIFRA and FFDA regulatory action by defining unreasonable adverse effects to include human risks from pesticides that do not meet the reasonable certainty of no harm standard of FFDCA sec.408.
Sec. 305 Pesticide Use Information Study
Requires USDA, in consultation with EPA, to report to Congress within 1 year on current status of Federal pesticide use information gathering activities and potential improvements.
Extends EPA authority to collect maintenance fees from 1997 to 2001 at the rate of $14 Million/year. Allows EPA to collect an additional $2 Million/year in each fiscal year 1998, 1999, 2000.
These funds must be deposited in the Reregistration and Expedited Processing Fund. The money may not be spent in any year to the extent that fee money would exceed appropriated money.
Requires, among other things, that EPA adopt cost accounting procedures approved by GAO and the Inspector General effective October 1, 1997.
These funds may only be used for reregistration and expedited processing. No more than 1/7 of the maintenance fees may be used for expedited processing. So long as EPA has not met expedited processing timeframes for any application submitted prior to enactment of the FQPA, EPA must use the full amount of the fees allowed for the purpose of meeting those timeframes. Once these backlogged applications are acted upon, this limitation is not in effect so long as EPA meets the timeframes for 90% of affected applications.
Requires the Inspector General to conduct an annual audit and report to the Administrator and the House/Senate Agriculture Committees. Costs for the audit shall come from the Fund.
Requires EPA to establish and publish annually in the Federal Register performance measures and goals for specified actions, including among others, reregistration, tolerance reassessment, and expedited processing.