(THROUGH P.L. 100-460, 100-464 to 100-526, & 100-532)
(References [ ] in brackets are to title 7, United States Code)
TABLE OF CONTENTS
U.S.C. Act Sec. Page
7 U.S.C.
prec. 121 1. Short title and table of contents 3
136 2. Definitions 7
136a 3. Registration of pesticides 13
136b 4. Reregistration of pesticides 22
136c 5. Experimental use permits 33
136d 6. Administrative review; suspension 34
136e 7. Registration of establishments 39
136f 8. Books and records 39
136g 9. Inspection of establishments, etc. 40
136h 10. Protection of trade secrets and other information. 41
136i 11. Use of restricted use pesticides; applicators. 44
136j 12. Unlawful acts. 45
136k 13. Stop sale, use, removal, and seizure 48
1361 14. Penalties 49
136m 15. Indemnities 50
136n 16. Administrative procedure; judicial review 52
136o 17. Imports and exports 53
136p 18. Exemption of Federal and State agencies 54
136q 19. Disposal and transportation 54
136r 20. Research and monitoring 58
136s 21. Solicitation of comments; notice of
public hearings. 59
136t 22. Delegation and cooperation 59
136u 23. State cooperation, aid, and training 59
136v 24. Authority of States 60
136w 25. Authority of Administrator 60
136w-1 26. State primary enforcement responsibility 64
136w-2 27. Failure by the State to assure enforcement of
State pesticide use regulations. 65
136w-3 28. Identification of pests; cooperation with
Department of Agriculture's program. 65
136w-4 29. Annual report 65
136x 30. Severability 65
136y 31. Authorization for appropriations 65
Bracketed material and footnotes did not appear in Acts.
Prepared by the Senate Legislative Counsel's Office.
TITLE 7 U.S. CODE, Sections 121 & 136-136y Federal Insecticide, Fungicide, and Rodenticide Act
Act of June 25, 1947
Chapter 125
AN ACT
To regulate the marketing of economic poisons and devices, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. [prec. 121] SHORT TITLE AND TABLE OF CONTENTS.
(a) SHORT TITLE.- This Act may be cited as the "Federal Insecticide, Fungicide, and Rodenticide Act".
(b) TABLE OF CONTENTS.-
Section 1. Short title and table of contents.
(a) Short title.
(b) Table of contents.
Sec. 2. Definitions.
(a) Active ingredient.
(b) Administrator.
(c) Adulterated.
(d) Animal.
(e) Certified applicator, etc.
(1) Certified applicator.
(2) Private applicator.
(3) Commercial applicator.
(4) Under the direct supervision of a certified applicator.
(f) Defoliant.
(g) Desiccant.
(h) Device.
(i) District court.
(1) Environment.
(k) Fungus.
(l) Imminent hazard.
(m) Inert ingredient.
(n) Ingredient statement.
(o) Insect.
(p) Label and labeling.
(1) Label.
(2) Labeling.
(q) Misbranded.
(r) Nematode.
(s) Person.
(t) Pest.
(u) Pesticide.
(v) Plant regulator.
(w) Producer and produce
(x) Protect health and the environment.
(y) Registrant.
(z) Registration.
(aa) State.
(bb) Unreasonable adverse effects on the environment.
(cc) Weed.
(dd) Establishment.
(ee) To use any registered pesticide in a manner inconsistent with its labeling.
(ff) Outstanding data requirement.
(gg) To distribute or sell.
Sec. 3. Registration of Pesticides
(a) Requirement of registration.
(b) Exemptions.
(c) Procedure for registration.
(1) Statement required.
(2) Data in support of registration
(3) Time for acting with respect to application.
(4) Notice of application.
(5) Approval of registration.
(6) Denial of registration.
(7) Registration under special circumstances.
(8) Interim administrative review.
(d) Classification of pesticides.
(1) Classification for general use, restricted use, or both.
(2) Change in classification.
(3) Change in classification from restricted use to general use.
(e) Products with same formulation and claims.
(f) Miscellaneous.
(1) Effect of change of labeling or formulation.
(2) Registration not a defense.
(3) Authority to consult other Federal agencies.
Sec. 4. Reregistration of registered pesticides.
(a) General rule.
(b) Reregistration phases.
(c) Phase one.
(1) Priority for reregistration.
(2) Reregistration lists.
(3) Judicial review.
(4) Notice to registrants.
(d) Phase two.
(1) In general.
(2) Notice of intent to seek or not to seek reregistration.
(3) Missing or inadequate data.
(4) Time periods.
(5) Cancellation and removal.
(6) Suspensions and penalties.
(e) Phase three.
(1) Information about studies.
(2) Time periods.
(3) Cancellation.
(4) Guidelines.
(5) Monitoring.
(f) Phase four.
(1) Independent review and identification of outstanding data requirements.
(2) Time periods.
(3) Suspensions and penalties
(g) Phase five.
(1) Data review.
(2) Reregistration and other actions
(h) Compensation of data submitter.
(i) Fees.
(1) Initial fee for food or feed use pesticide active ingredients.
(2) Final fee for food or feed use pesticide active ingredients.
(3) Fees for other pesticide active ingredients.
(4) Reduction or waiver of fees for minor use and other pesticides.
(5) Maintenance fee.
(6) Other fees.
(7) Apportionment.
(j) Exemption of certain registrants
(k) Reregistration and expedited processing fund.
(1) Establishment.
(2) Source and use.
(3) Expedited processing of similar applications.
(4) Unused funds.
(5) Accounting.
(l) Judicial review.
Sec. 5. Experimental use permits.
(a) Issuance.
(b) Temporary tolerance level.
(c) Use under permit.
(d) Studies.
(e) Revocation.
(f) State issuance of permits.
(g) Exemption for agricultural research agencies.
Sec. 6. Administrative review; suspension.
(a) Cancellation after five years.
(1) Procedure.
(2) Information.
(b) Cancellation and change in classification or labels.
(c) Suspension.
(1) Order.
(2) Expedite hearing.
(3) Emergency order.
(4) Judicial review.
(d) Public hearings and scientific review.
(e) Conditional registration.
(f) General provisions.
(1) Voluntary cancellation.
(2) Publication of notice.
(g) Notice for stored pesticides with canceled or suspended registrations.
(1) In general.
(2) Copies.
(h) Judicial review.
Sec. 7. Registration of establishments.
(a) Requirements.
(b) Registration.
(c) Information required.
(d) Confidential records and information.
Sec. 8. Records.
(a) Requirement.
(b) Inspection.
Sec. 9. Inspection of establishments, etc.
(a) In general.
(b) Warrants.
(c) Enforcement.
(1) Certification of facts to Attorney General.
(2) Notice not required.
(3) Warning notices.
Sec. 10. Protection of trade secrets and other information.
(a) In general.
(b) Disclosure.
(c) Disputes.
(d) Limitations.
(e) Disclosure to contractors.
(f) Penalty for disclosure by Federal employees.
(g) Disclosure to foreign and multinational pesticide producers.
Sec. 11. Use of restricted use pesticides; applicators.
(a) Certification procedure.
(1) Federal certification.
(2) State certification.
(b) State plans.
(c) Instruction in integrated pest management techniques.
(d) In general.
(e) Separate standards.
Sec. 12. Unlawful acts.
(a) In general.
(b) Exemptions.
Sec. 13. Stop sale, use, removal, and seizure.
(a) Stop sale, etc., orders.
(b) Seizure.
(c) Disposition after condemnation.
(d) Court costs, etc.
Sec. 14. Penalties.
(a) Civil penalties.
(1) In general.
(2) Private applicator.
(3) Hearing.
(4) Determination of penalty.
(5) References to Attorney general.
(b) Criminal penalties.
(1) In general.
(2) Private applicator.
(3) Disclosure of information.
(4) Acts of officers, agents, etc.
Sec. 15. Indemnities.
(a) General indemnification.
(1) In general.
(2) Exception.
(3) Report.
(4) Appropriation.
(b) Indemnification of end users, dealers, and distributors.
(1) End users.
(2) Dealers and distributors.
(3) Source.
(4) Administrative settlement.
(c) Amount of payment.
(1) In general.
(2) Special rule.
Sec. 16. Administrative procedure; judicial review.
(a) District court review.
(b) Review by Court of Appeals.
(c) Jurisdiction of district courts.
(d) Notice of judgments.
Sec. 17. Imports and exports.
(a) Pesticides and devices intended for export.
(b) Cancellation notices furnished to foreign governments.
(c) Importation of pesticides and devices.
(d) Cooperation in international efforts.
(e) Regulations.
Sec. 18. Exemption of Federal and State agencies.
Sec. 19. Storage, disposal, transportation, and recall.
(a) Storage, disposal, and transportation.
(1) Data requirements and registration of pesticides.
(2) Pesticides.
(3) Containers, rinsates, and other materials.
(b) Recalls.
(1) In general.
(2) Voluntary recall.
(3) Mandatory recall.
(4) Recall procedure.
(5) Contents of recall plan.
(6) Requirements or procedures.
(c) Storage costs.
(1) Submission of plan.
(2) Reimbursement.
(d) Administration of storage, disposal, transportation, and recall programs.
(1) Voluntary agreements.
(2) Rule and regulation review.
(3) Limitations.
(4) Seizure and penalties.
(e) Container design.
(1) Procedures.
(2) Compliance.
(f) Pesticide residue removal.
(1) Procedures.
(2) Compliance.
(3) Solid Waste Disposal Act.
(g) Pesticide container study.
(1) Study.
(2) Report.
(h) Relationship to Solid Waste Disposal Act
Sec. 20. Research and monitoring.
(a) Research.
(b) National monitoring plan.
(c) Monitoring.
Sec. 21. Solicitation of comments; notice of public hearings.
(a) Secretary of Agriculture.
(b) Views.
(c) Notice.
Sec. 22. Delegation and cooperation.
(a) Delegation.
(b) Cooperation.
Sec. 23. State cooperation, aid, and training.
(a) Cooperative agreements.
(b) Contracts for training.
(c) Information and education.
Sec. 24. Authority of States.
(a) In general.
(b) Uniformity.
(c) Additional uses.
Sec. 25. Authority of Administrator.
(a) In General.
(1) Regulations.
(2) Procedure.
(3) Congressional committees.
(4) Congressional review of regulations.
(b) Exemption of pesticides.
(c) Other authority.
(d) Scientific advisory panel.
Sec. 26. State primary enforcement responsibility.
(a) In general.
(b) Special rules.
(c) Administrator.
Sec. 27. Failure by the State to assure enforcement of State pesticide use regulations.
(a) Referral.
(b) Notice.
(c) Construction.
Sec. 28. Identification of pests; cooperation with Department of Agriculture's program.
Sec. 29. Annual report.
Sec. 30. Severability.
Sec. 31. Authorization for appropriations.
SEC. 2. [136] DEFINITIONS.
For purposes of this Act-
(a) ACTIVE INGREDIENT.-The term active ingredient means-
(1) in the case of a pesticide other than a plant regulator, defoliant, or desiccant, an ingredient which will prevent, destroy, repel, or mitigate any pest;
(2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate of growth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof;
(3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant; and
(4) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue.
(b) ADMINISTRATOR.-The term Administrator means the Administrator of the Environmental Protection Agency.
(c) ADULTERATED.-The term adulterated applies to any pesticide if-
(1) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold;
(2) any substance has been substituted wholly or in part for the pesticide; or
(3) any valuable constituent of the pesticide has been wholly or in part abstracted.
(d) ANIMAL.-The term "animal" means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds, fish, and shellfish.
(e) CERTIFIED APPLICATOR, ETC.-
(1) CERTIFIED APPLICATOR.-The term certified applicator means any individual who is certified under section 4 2-1 as authorized to use or supervise the use of any pesticide which is classified for restricted use. Any applicator who holds or applies registered pesticides, or use dilutions of registered pesticides consistent with section 2(ee) of this Act, only to provide a service of controlling pests without delivering any unapplied pesticide to any person so served is not deemed to be a seller or distributor of pesticides under this Act.
__________
2-1 in original. Probably should be "section 11".
(2) PRIVATE APPLICATOR.-The term private applicator means a certified applicator who uses or supervises the use of any pesticide which is classified for restricted use for purposes of producing any agricultural commodity on property owned or rented by him or his employer or (if applied without compensation other than trading of personal services between producers of agricultural commodities) on the property of another person.
(3) COMMERCIAL APPLICATOR.-The term commercial applicator" means an applicator (whether or not he is a private applicator with respect to some uses) who uses or supervises the use of any pesticide which is classified for restricted use for any purpose or on any property other than as provided by paragraph (2).
(4) UNDER THE DIRECT SUPERVISION OF A CERTIFIED APPLICATOR.-Unless otherwise prescribed by its labeling, a pesticide shall be considered to be applied under the direct supervision of a certified applicator if it is applied by a competent person acting under the instructions and control of a certified applicator who is available if and when needed, even though such certified applicator is not physically present at the time and place the pesticide is applied.
(f) DEFOLIANT.-The term "defoliant" means any substance or mixture of substances intended for causing the leaves or foliage to drop from a plant, with or without causing abscission.
(g) DESICCANT.-The term "desiccant" means any substance or mixture of substances intended for artificially accelerating the drying of plant tissue.
(h) DEVICE.-The term "device" means any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides when sold separately therefrom.
(i) DISTRICT COURT.-The term "district court" means a United States district court, the District Court of Guam, the District Court of the Virgin Islands, and the highest court of American Samoa.
(j) ENVIRONMENT.-The term "environment" includes water, air, land, and all plants and man and other animals living therein, and the interrelationships which exist among these.
(k) FUNGUS.-The term "fungus" means any non-chlorophyll-bearing thallophyte (that is, any non-chlorophyll-bearing plant of a lower order than mosses and liverworts), as for example, rust, smut, mildew, mold, yeast, and bacteria, except those on or in living man or other animals and those on or in processed food, beverages, or pharmaceuticals.
(l) IMMINENT HAZARD.-The term "imminent hazard" means a situation which exists when the continued use of a pesticide during the time required for cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involve unreasonable hazard to the survival of a species declared endangered by the Secretary of the Interior under Public Law 91-135.
(m) INERT INGREDIENT.-The term "inert ingredient" means an ingredient which is not active.
(n) INGREDIENT STATEMENT.-The term ingredient statement means a statement which contains-
(1) the name and percentage of each active ingredient, and the total percentage of all inert ingredients, in the pesticide; and
(2) if the pesticide contains arsenic in any form, a statement of the percentages of total and water soluble arsenic, calculated as elementary arsenic.
(o) INSECT.-The term "insect" means any of the numerous small invertebrate animals generally having the body more or less obviously segmented, for the most part belonging to the class insecta, comprising six-legged, usually winged forms, as for example, beetles, bugs, bees, flies, and to other allied classes of arthropods whose members are wingless and usually have more than six legs, as for example, spiders, mites, ticks, centipedes, and wood lice.
(p) LABEL AND LABELING.-
(1) LABEL.-The term "label" means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.
(2) LABELING.-The term "labeling" means all labels and all other written, printed, or graphic matter-
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature accompanying the pesticide or device, except to current official publications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, the Department of Health and Human Services, State experiment stations, State agricultural colleges, and other similar Federal or State institutions or agencies authorized by law to conduct research in the field of pesticides.
(q) MISBRANDED.-
(1) A pesticide is misbranded if-
(A) its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular;
(B) it is contained in a package or other container or wrapping which does not conform to the standards established by the Administrator pursuant to section 25(c)(3);
(C) it is an imitation of, or is offered for sale under the name of, another pesticide;
(D) its label does not bear the registration number assigned under section 7 to each establishment in which it was produced;
(E) any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(F) the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and if complied with, together with any requirements imposed under section 3(d) of this Act, are adequate to protect health and the environment;
(G) the label does not contain a warning or caution statement which may be necessary and if complied with, together with any requirements imposed under section 3(d) of this Act, is adequate to protect health and the environment; or
(H) in the case of a pesticide not registered in accordance with section 3 of this Act and intended for export, the label does not contain, in words prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual under customary conditions of purchase and use, the following: "Not Registered for Use in the United States of America".
(2) A pesticide is misbranded if-
(A) the label does not bear an ingredient statement on that part of the immediate container (and on the outside container or wrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannot be clearly read) which is presented or displayed under customary conditions of purchase, except that a pesticide is not misbranded under this subparagraph if-
(i) the size of form of the immediate container, or the outside container or wrapper of the retail package, makes it impracticable to place the ingredient statement on the part which is presented or displayed under customary conditions of purchase; and
(ii) the ingredient statement appears prominently on another part of the immediate container, or outside container or wrapper, permitted by the Administrator;
(B) the labeling does not contain a statement of the use classification under which the product is registered;
(C) there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, through which the required information on the immediate container cannot be clearly read, a label bearing-
(i) the name and address of the producer, registrant, or person for whom produced;
(ii) the name, brand, or trademark under which the pesticide is sold;
(iii) the net weight or measure of the content, except that the Administrator may permit reasonable variations; and
(iv) when required by regulation of the Administrator to effectuate the purposes of this Act, the registration number assigned to the pesticide under this Act, and the use classification; and
(D) the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, in addition to any other matter required by this Act-
(i) the skull and crossbones;
(ii) the word "poison" prominently in red on a background of distinctly contrasting color; and
(iii) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide.
(r) NEMATODE.-The term "nematode" means invertebrate animals of the phylum nemathelminthes and class nematoda, that is, unsegmented round worms with elongated, fusiform, or saclike bodies covered with cuticle, and inhabiting soil, water, plants, or plant parts; may also be called nemas or eelworms.
(s) PERSON.-The term "person" means any individual, partnership, association, corporation, or any organized group of persons whether incorporated or not.
(t) PEST.-The term "pest" means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant or animal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living man or other living animals) which the Administrator declares to be a pest under section 25(c)(1).
(u) PESTICIDE.-The term "pesticide" means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, except that the term "pesticide" shall not include any article that is a "new animal drug' within the meaning of section 201(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(w)), that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning of section 201(x) of such Act (21 U.S.C. 321(x)) bearing or containing a new animal drug.
(v) PLANT REGULATOR.-The term "plant regulator" means any substance or mixture of substances intended, through physiological action, for accelerating or retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, but shall not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants, and soil amendments. Also, the term "plant regulator" shall not be required to include any of such of those nutrient mixtures or soil amendments as are commonly known as vitamin-hormone horticultural products, intended for improvement, maintenance, survival, health, and propagation of plants, and as are not for pest destruction and are nontoxic, nonpoisonous in the undiluted packaged concentration.
(w) PRODUCER AND PRODUCE.-The term producer means the person who manufacturers, prepares, compounds, propagates, or processes any pesticide or device or active ingredient used in producing a pesticide. The term "produce" means to manufacture, prepare, compound, propagate, or process any pesticide or device or active ingredient used in producing a pesticide. The dilution by individuals of formulated pesticides for their own use and according to the directions on registered labels shall not of itself result in such individuals being included in the definition of "producer" for the purposes of this Act.
(x) PROTECT HEALTH AND THE ENVIRONMENT.-The terms protect health and the environment" and "protection of health and the environment" mean protection against any unreasonable adverse effects on the environment.
(y) REGISTRANT.-The term "registrant" means a person who has registered any pesticide pursuant to the provisions of this Act.
(z) REGISTRATION.-The term "registration" includes reregistration.
(aa) STATE.-The term "State" means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa.
(bb) UNREASONABLE ADVERSE EFFECTS ON THE ENVIRONMENT.- The term "unreasonable adverse effects on the environment" means any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.
(cc) WEED.-The term "weed" means any plant which grows where not wanted.
(dd) ESTABLISHMENT.-The term "establishment" means any place where a pesticide or device or active ingredient used in producing a pesticide is produced, or held, for distribution or sale.
(ee) To USE ANY REGISTERED PESTICIDE IN A MANNER INCONSISTENT WITH ITS LABELING.-The term to use any registered pesticide in a manner inconsistent with its labeling" means to use any registered pesticide in a manner not permitted by the labeling, except that the term shall not include (1) applying a pesticide at any dosage, concentration, or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage, concentration, or frequency, (2) applying a pesticide against any target pest not specified on the labeling if the application is to the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically state that the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the use of the pesticide against other pests would cause an unreasonable adverse effect on the environment, (3) employing any method of application not prohibited by the labeling unless the labeling specifically states that the product may be applied only by the methods specified on the labeling, (4) mixing a pesticide or pesticides with a fertilizer when such mixture is not prohibited by the labeling, (5) any use of a pesticide in conformance with section 5, 18, or 24 of this Act, or (6) any use of a pesticide in a manner that the Administrator determines to be consistent with the purposes of this Act. After March 31, 1979, the term shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosage unless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study provided for in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory opinion specifically requires the use of definite amounts of dilution.
(ff) OUTSTANDING DATA REQUIREMENT.-
(1) IN GENERAL.-The term "outstanding data requirement" means a requirement for any study, information, or data that is necessary to make a determination under section 3(c)(5) and which study, information, or data-
(A) has not been submitted to the Administrator; or
(B) if submitted to the Administrator, the Administrator has determined must be resubmitted because it is not valid, complete, or adequate to make a determination under section 3(c)(5) and the regulations and guidelines issued under such section.
(2) FACTORS.-In making a determination under paragraph (1)(B) respecting a study, the Administrator shall examine, at a minimum, relevant protocols, documentation of the conduct and analysis of the study, and the results of the study to determine whether the study and the results of the study fulfill the data requirement for which the study was submitted to the Administrator.
(gg) To DISTRIBUTE OR SELL.-The term "to distribute or sell" means to distribute, sell, offer for sale, hold for distribution, hold for sale, hold for shipment, ship, deliver for shipment, release for shipment, or receive and (having so received) deliver or offer to deliver. The term does not include the holding or application of registered pesticides or use dilutions thereof by any applicator who provides a service of controlling pests without delivering any unapplied pesticide to any person so served.
SEC. 3. [136a] REGISTRATION OF PESTICIDES.
(a) REQUIREMENT OF REGISTRATION.-Except as provided by this Act, no person in any State may distribute or sell to any person any pesticide that is not registered under this Act. To the extent necessary to prevent unreasonable adverse effects on the environment, the Administrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered under this Act and that is not the subject of an experimental use permit under section 5 or an emergency exemption under section 18.
(b) EXEMPTIONS.-A pesticide which is not registered with the Administrator may be transferred if-
(1) the transfer is from one registered establishment to another registered establishment operated by the same producer solely for packaging at the second establishment or for use as a constituent part of another pesticide produced at the second establishment; or
(2) the transfer is pursuant to and in accordance with the requirements of an experimental use permit.
(c) PROCEDURE FOR REGISTRATION.-
(1) STATEMENT REQUIRED.-Each applicant for registration of a pesticide shall file with the Administrator a statement which includes-
(A) the name and address of the applicant and of any other person whose name will appear on the labeling;
(B) the name of the pesticide;
(C) a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use;
(D) except as otherwise provided in paragraph (2)(D), if requested by the Administrator, a full description of the tests made and the results thereof upon which the claims are based, or alternatively a citation to data that appear in the public literature or that previously had been submitted to the Administrator and that the Administrator may consider in accordance with the following provisions:
(i) with respect to pesticides containing active ingredients that are initially registered under this Act after the date of enactment of the Federal Pesticide Act of 1978 [September 30, 1978], data submitted to support the application for the original registration of the pesticide, or an application for an amendment adding any new use to the registration and that pertains solely to such new use, shall not, without the written permission of the original data submitter, be considered by the Administrator to support an application by another person during a period of ten years following the date the Administrator first registers the pesticide, except that such permission shall not be required in the case of defensive data;
(ii) except as otherwise provided in clause (i), with respect to data submitted after December 31, 1969, by an applicant or registrant to support an application for registration, experimental use permit, or amendment adding a new use to an existing registration, to support or maintain in effect an existing registration, or for reregistration, the Administrator may, without the permission of the original data submitter, consider any such item of data in support of an application by any other person (hereinafter in this subparagraph referred to as the "applicant") within the fifteen-year period following the date the data were originally submitted only if the applicant has made an offer to compensate the original data submitter and submitted such offer to the Administrator accompanied by evidence of delivery to the original data submitter of the offer. The terms and amount of compensation may be fixed by agreement between the original data submitter and the applicant, or, failing such agreement, binding arbitration under this subparagraph. If, at the end of ninety days after the date of delivery to the original data submitter of the offer to compensate, the original data submitter and the applicant have neither agreed on the amount and terms of compensation nor on a procedure for reaching an agreement on the amount and terms of compensation, either person may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. If the Administrator determines that an original data submitter has failed to participate in a procedure for reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the original data submitter shall forfeit the right to compensation for the use of the data in support of the application. Notwithstanding any other provision of this Act, if the Administrator determines that an applicant has failed to participate in a procedure for reaching an agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of an agreement or arbitration decision concerning compensation under this subparagraph, the Administrator shall deny the application or cancel the registration of the pesticide in support of which the data were used without further hearing. Before the Administrator takes action under either of the preceding two sentences, the Administrator shall furnish to the affected person, by certified mail, notice of intent to take action and allow fifteen days from the date of delivery of the notice for the affected person to respond. If a registration is denied or canceled under this subparagraph, the Administrator may make such order as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Registration action by the Administrator shall not be delayed pending the fixing of compensation;
(iii) after expiration of any period of exclusive use and any period for which compensation is required for the use of an item of data under clauses (i) and (ii), the Administrator may consider such item of data in support of an application by any other applicant without the permission of the original data submitter and without an offer having been received to compensate the original data submitter for the use of such item of data;
(E) the complete formula of the pesticide; and
(F) a request that the pesticide be classified for general use for restricted use, or for both.
(2) DATA IN SUPPORT OF REGISTRATION.-
(A) The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter he requires any additional kind of information under subparagraph (B) of this paragraph, he shall permit sufficient time for applicants to obtain such additional information. The Administrator, in establishing standards for data requirements for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent of use, pattern of use, and the level and degree of potential exposure of man and the environment to the pesticide. In the development of these standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of the cost of meeting the requirements on the incentives for any potential registrant to undertake the development of the required data. Except as provided by section 10, within 30 days after the Administrator registers a pesticide under this Act he shall make available to the public the data called for in the registration statement together with such other scientific information as he deems relevant to his decision.
(B)-
(i) If the Administrator determines that additional data are required to maintain in effect an existing registration of a pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested person.
(ii) Each registrant of such pesticide shall provide evidence within ninety days after receipt of notification that it is taking appropriate steps to secure the additional data that are required. Two or more registrants may agree to develop jointly, or to share in the cost of developing, such data if they agree and advise the Administrator of their intent within ninety days after notification. Any registrant who agrees to share in the cost of producing the data shall be entitled to examine and rely upon such data in support of maintenance of such registration. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.
(iii) If, at the end of sixty days after advising the Administrator of their agreement to develop jointly, or share in the cost of developing data, the registrants have not further agreed on the terms of the data development arrangement or on a procedure for reaching such agreement, any of such registrants may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant fails to comply with this clause.
(iv) Notwithstanding any other provision of this Act, if the Administrator determines that a registrant, within the time required by the Administrator, has failed to take appropriate steps to secure the data required under this subparagraph, to participate in a procedure for reaching agreement concerning a joint data development arrangement under this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the terms of an agreement or arbitration decision concerning a joint data development arrangement under this subparagraph, the Administrator may issue a notice of intent to suspend such registrant's registration of the pesticide for which additional data is required. The Administrator may include in the notice of intent to suspend such provisions as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Any suspension proposed under this subparagraph shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to suspend, unless during that time a request for hearing is made by a person adversely affected by the notice or the registrant has satisfied the Administrator that the registrant has complied fully with the requirements that served as a basis for the notice of intent to suspend. If a hearing is requested, a hearing shall be conducted under section 6(d) of this Act. The only matters for resolution at that hearing shall be whether the registrant has failed to take the action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data is required, and whether the Administrator's determination with respect to the disposition of existing stocks is consistent with this Act. If a hearing is held, a decision after completion of such hearing shall be final. Notwithstanding any other provision of this Act, a hearing shall be held and a determination made within seventy-five days after receipt of a request for such hearing. Any registration suspended under this subparagraph shall be reinstated by the Administrator if the Administrator determines that the registrant has complied fully with the requirements that served as a basis for the suspension of the registration.
(v) Any data submitted under this subparagraph shall be subject to the provisions of paragraph (1)(D). Whenever such data are submitted jointly by two or more registrants, an agent shall be agreed on at the time of the joint submission to handle any subsequent data compensation matters for the joint submitters of such data.
(C) Within nine months after the date of enactment of this subparagraph [September 30, 1978], the Administrator shall, by regulation, prescribe simplified procedures for the registration of pesticides, which shall include the provisions of subparagraph (D) of this paragraph.
(D) EXEMPTION.- No applicant for registration of a pesticide who proposes to purchase a registered pesticide from another producer in order to formulate such purchased pesticide into the pesticide that is the subject of the application 3-1 shall be required to-
__________
3-1 Section 102(b)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act Amendments of 1988 (P.L. 100-532) amended this subparagraph by striking out "an end use product" and inserting in lieu thereof "the pesticide that is the subject of the application". Before the amendment, the text of this subparagraph contained the phrase "an end-use product", with a hyphen. The amendment was executed to this subparagraph to effectuate the probable intent of Congress.
(i) submit or cite data pertaining to such purchased product; or
(ii) offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of any such data.
(3) TIME FOR ACTING WITH RESPECT TO APPLICATION.-
(A) The Administrator shall review the data after receipt of the application and shall, as expeditiously as possible, either register the pesticide in accordance with paragraph (5), or notify the applicant of his determination that it does not comply with the provisions of the Act in accordance with paragraph (6).
(B)-
(i) The Administrator shall, as expeditiously as possible, review and act on any application received by the Administrator that-
(I) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or
(II) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data.
(ii) In expediting the review of an application for an action described in clause (i), the Administrator shall-
(I) within 45 days after receiving the application, notify the registrant whether or not the application is complete and, if the application is found to be incomplete, reject the application;
(II) within 90 days after receiving a complete application, notify the registrant if the application has been granted or denied; and
(III) if the application is denied, notify the registrant in writing of the specific reasons for the denial of the application.
(4) NOTICE OF APPLICATION.- The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other data required pursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new active ingredient or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federal agency or any other interested person may comment.
(5) APPROVAL OF REGISTRATION.- The Administrator shall register a pesticide if he determines that, when considered with any restrictions imposed under subsection (d)-
(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be submitted comply with the requirements of this Act;
(C) it will perform its intended function without unreasonable adverse effects on the environment; and
(D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.
The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where two pesticides meet the requirements of this paragraph, one should not be registered in preference to the other. In considering an application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy, in which event the Administrator may register the pesticide with out determining that the pesticide's composition is such as to warrant proposed claims of efficacy. If a pesticide is found to be efficacious by any State under section 24(c) of this Act, a presumption is established that the Administrator shall waive data requirements pertaining to efficacy for use of the pesticide in such State.
(6) DENIAL OF REGISTRATION.-If the Administrator determines that the requirements of paragraph (5) for registration are not satisfied, he shall notify the applicant for registration of his determination and of his reasons (including the factual basis) therefor, and that, unless the applicant corrects the conditions and notifies the Administrator thereof during the 30-day period beginning with the day after the date on which the applicant receives the notice, the Administrator may refuse to register the pesticide. Whenever the Administrator refuses to register a pesticide, he shall notify the applicant of his decision and of his reasons (including the factual basis) therefor. The Administrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor. Upon such notification, the applicant for registration or other interested person with the concurrence of the applicant shall have the same remedies as provided for in section 6.
(7) REGISTRATION UNDER SPECIAL CIRCUMSTANCES.- Notwithstanding the provisions of paragraph (5)-
(A) The Administrator may conditionally register or amend the registration of a pesticide if the Administrator determines that (i) the pesticide and proposed use are identical or substantially similar to any currently registered pesticide and use thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, and (ii) approving the registration or amendment in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. An applicant seeking conditional registration or amended registration under this subparagraph shall submit such data as would be required to obtain registration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item of data because it has not yet been generated, the Administrator may register or amend the registration of the pesticide under such conditions as will require the submission of such data not later than the time such data are required to be submitted with respect to similar pesticides already registered under this Act.
(B) The Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticide notwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if the Administrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use, and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk of any unreasonable adverse effect on the environment. Notwithstanding the foregoing provisions of this subparagraph, no registration of a pesticide may be amended to permit an additional use of such pesticide if the Administrator has issued a notice stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria associated in whole or in part with human dietary exposure enumerated in regulations issued under this Act, and during the pendency of any risk-benefit evaluation initiated by such notice, if (I) the additional use of such pesticide involves a major food or feed crop, or (II) the additional use of such pesticide involves a minor food or feed crop and the Administrator determines, with the concurrence of the Secretary of Agriculture, there is available an effective alternative pesticide that does not meet or exceed such risk criteria. An applicant seeking amended registration under this subparagraph shall submit such 1 data as would be required to obtain registration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item of data (other than data pertaining to the proposed additional use) because it has not yet been generated, the Administrator may amend the registration under such conditions as will require the submission of such data not later than the time such data are required to be submitted with respect to similar pesticides already registered under this Act.
(C) The Administrator may conditionally register a pesticide containing an active ingredient not contained in any currently registered pesticide for a period reasonably sufficient for the generation and submission of required data (which are lacking because a period reasonably sufficient for generation of the data has not elapsed since the Administrator first imposed the data requirement) on the condition that by the end of such period the Administrator receives such data and the data do not meet or exceed risk criteria enumerated in regulations issued under this Act, and on such other conditions as the Administrator may prescribe. A conditional registration under this subparagraph shall be granted only if the Administrator determines that use of the pesticide during such period will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is in the public interest.
(8) INTERIM ADMINISTRATIVE REVIEW.-Notwithstanding any other provision of this Act, the Administrator may not initiate a public interim administrative review process to develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses prior to initiating a formal action to cancel, suspend, or deny registration of such pesticide, required under this Act, unless such interim administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasonable adverse risk to man or to the environment. Notice of the definition of the terms "validated test" and "other significant evidence" as used herein shall be published by the Administrator in the Federal Register.
(d) CLASSIFICATION OF PESTICIDES.-
(1) CLASSIFICATION FOR GENERAL USE, RESTRICTED USE, OR BOTH.-
(A) As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricted use. If the Administrator determines that some of the uses for which the pesticide is registered should be for general use and that other uses for which it is registered should be for restricted use, he shall classify it for both general use and restricted use. Pesticide uses may be classified by regulation on the initial classification and registered pesticides may be classified prior to reregistration. If some of the uses of the pesticide are classified for general use and other uses are classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished from those directions relating to its restricted uses. The Administrator may require that its packaging and labeling for restricted uses shall be clearly distinguishable from its packaging and labeling for general uses.
(B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, will not generally cause unreasonable adverse effects on the environment, he will classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use.
(C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings and cautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread and commonly recognized practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effects on the environment, including injury to the applicator, he shall classify the pesticide, or the particular use or uses to which the determination applies, for restricted use:
(i) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that the acute dermal or in halation toxicity of the pesticide presents a hazard to the applicator or other persons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the direct supervision of a certified applicator.
(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of a determination that its use without addition al regulatory restriction may cause unreasonable adverse effects on the environment, the pesticide shall be applied for any use to which the determination applies only by or under the direct supervision of a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation. Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a person adversely affected filed within 60 days of the publication of the regulation in final form.
(2) CHANGE IN CLASSIFICATION.- If the Administrator determines that a change in the classification of any use of a pesticide from general use to restricted use is necessary to prevent unreasonable adverse effects on the environment, he shall notify the registrant of such pesticide of such determination at least forty-five days before making the change and shall publish the proposed change in the Federal Register. The registrant, or other interested person with the concurrence of the registrant, may seek relief from such determination under section 6(b).
(3) CHANGE IN CLASSIFICATION FROM RESTRICTED USE TO GENERAL USE.- The registrant of any pesticide with one or more uses classified for restricted use may petition the Administrator to change any such classification from restricted to general use. Such petition shall set out the basis for the registrant's position that restricted use classification is unnecessary because classification of the pesticide for general use would not cause unreasonable adverse effects on the environment. The Administrator, within sixty days after receiving such petition, shall notify the registrant whether the petition has been granted or denied. Any denial shall contain an explanation therefor and any such denial shall be subject to judicial review under section 16 of this Act.
(e) PRODUCTS WITH SAME FORMULATION AND CLAIMS.- Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a single pesticide; and additional names and labels shall be added to the registration by supplemental statements.
(f) MISCELLANEOUS.-
(1) EFFECT OF CHANGE OF LABELING OR FORMULATION.- If the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if the Administrator determines that the change will not violate any provision of this Act.
(2) REGISTRATION NOT A DEFENSE.- In no event shall registration of an article be construed as a defense for the commission of any offense under this Act. As long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide, its labeling and packaging comply with the registration provisions of the Act.
(3) AUTHORITY TO CONSULT OTHER FEDERAL AGENCIES.- In connection with consideration of any registration or application for registration under this section, the Administrator may consult with any other Federal agency.
SEC. 4. [136b] REREGISTRATION OF REGISTERED PESTICIDES.
(a) GENERAL RULE.- The Administrator shall reregister, in accordance with this section, each registered pesticide containing any active ingredient contained in any pesticide first registered before November 1, 1984, except for any pesticide as to which the Administrator has determined, after November 1, 1984, and before the effective date of this section [December 24, 1988], that-
(1) there are no outstanding data requirements; and
(2) the requirements of section 3(c)(5) have been satisfied.
(b) REREGISTRATION PHASES.- Reregistrations of pesticides under this section shall be carried out in the following phases:
(1) The first phase shall include the listing under subsection (c) of the active ingredients of the pesticides that will be reregistered.
(2) The second phase shall include the submission to the Administrator under subsection (d) of notices by registrants respecting their intention to seek reregistration, identification by registrants of missing and inadequate data for such pesticides, and commitments by registrants to replace such missing or inadequate data within the applicable time period.
(3) The third phase shall include submission to the Administrator by registrants of the information required under subsection (e).
(4) The fourth phase shall include an independent, initial review by the Administrator under subsection (f) of submissions under phases two and three, identification of outstanding data requirements, and the issuance, as necessary, of requests for additional data.
(5) The fifth phase shall include the review by the Administrator under subsection (g) of data submitted for reregistration and appropriate regulatory action by the Administrator.
(c) PHASE ONE.-
(1) PRIORITY FOR REREGISTRATION.- For purposes of the reregistration of the pesticides described in subsection (a), the Administrator shall list the active ingredients of pesticides and shall give priority to, among others, active ingredients (other than active ingredients for which registration standards have been issued before the effective date of this section [December 24, 1988]) that-
(A) are in use on or in food or feed and may result in postharvest residues;
(B) may result in residues of potential toxicological concern in potable ground water, edible fish, or shellfish;
(C) have been determined by the Administrator before the effective date of this section [December 24, 1988] to have significant outstanding data requirements; or
(D) are used on crops, including in greenhouses and nurseries, where worker exposure is most likely to occur.
(2) REREGISTRATION LISTS.- For purposes of reregistration under this section, the Administrator shall by order-
(A) not later than 70 days after the effective date of this section [December 24, 1988], list pesticide active ingredients for which registration standards have been issued before such effective date;
(B) not later than 4 months after such effective date, list the first 150 pesticide active ingredients, as determined under paragraph (1);
(C) not later than 7 months after such effective date, list the second 150 pesticide active ingredients, as determined under paragraph (1); and
(D) not later than 10 months after such effective date, list the remainder of the pesticide active ingredients, as determined under paragraph (1).
Each list shall be published in the Federal Register.
(3) JUDICIAL REVIEW.- The content of a list issued by the Administrator under paragraph (2) shall not be subject to judicial review.
(4) NOTICE TO REGISTRANTS.- On the publication of a list of pesticide active ingredients under paragraph (2), the Administrator shall send by certified mail to the registrants of the pesticides containing such active ingredients a notice of the time by which the registrants are to notify the Administrator under subsection (d) whether the registrants intend to seek or not to seek reregistration of such pesticides.
(d) PHASE TWO.-
(1) IN GENERAL.- The registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall submit to the Administrator, within the time period prescribed by paragraph (4), the notice described in paragraph (2) and any information, commitment, or offer described in paragraph (3).
(2) NOTICE OF INTENT TO SEEK OR NOT TO SEEK REREGISTRATION.-
(A) The registrant of a pesticide containing an active ingredient listed under subparagraph (B), (C), or (D) of sub section (c)(2) shall notify the Administrator by certified mail whether the registrant intends to seek or does not intend to seek reregistration of the pesticide.
(B) If a registrant submits a notice under subparagraph (A) of an intention not to seek reregistration of a pesticide, the Administrator shall publish a notice in the Federal Register stating that such a notice has been submitted.
(3) MISSING OR INADEQUATE DATA.- Each registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) and for which the registrant submitted a notice under paragraph (2) of an intention to seek reregistration of such pesticide shall submit to the Administrator-
(A) in accordance with regulations issued by the Administrator under section 3, an identification of-
(i) all data that are required by regulation to support the registration of the pesticide with respect to such active ingredient;
(ii) data that were submitted by the registrant previously in support of the registration of the pesticide that are inadequate to meet such regulations; and
(iii) data identified under clause (i) that have not been submitted to the Administrator; and
(B) either-
(i) a commitment to replace the data identified under subparagraph (A)(ii) and submit the data identified under subparagraph (A)(iii) within the applicable time period prescribed by paragraph (4)(B); or
(ii) an offer to share in the cost to be incurred by a person who has made a commitment under clause (i) to replace or submit the data and an offer to submit to arbitration as described by section 3(c)(2)(B) with regard to such cost sharing.
For purposes of a submission by a registrant under subparagraph (A)(ii), data are inadequate if the data are derived from a study with respect to which the registrant is unable to make the certification prescribed by subsection (e)(1)(G) that the registrant possesses or has access to the raw data used in or generated by such study. For purposes of a submission by a registrant under such subparagraph, data shall be considered to be inadequate if the data are derived from a study submitted before January 1, 1970, unless it is demonstrated to the satisfaction of the Administrator that such data should be considered to support the registration of the pesticide that is to be reregistered.
(4) TIME PERIODS.-
(A) A submission under paragraph (2) or (3) shall be made-
(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B) not later than 3 months after the date of publication of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C) not later than 3 months after the date of publication of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D) not later than 3 months after the date of publication of the listing of such active ingredient.
On application, the Administrator may extend a time period prescribed by this subparagraph if the Administrator determines that factors beyond the control of the registrant prevent the registrant from complying with such period.
(B) A registrant shall submit data in accordance with a commitment entered into under paragraph (3)(B) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period.
(5) CANCELLATION AND REMOVAL.-
(A) If the registrant of a pesticide does not submit a notice under paragraph (2) or (3) within the time prescribed by paragraph (4)(A), the Administrator shall issue a notice of intent to cancel the registration of such registrant for such pesticide and shall publish the notice in the Federal Register and allow 60 days for the submission of comments on the notice. On expiration of such 60 days, the Administrator, by order and without a hearing, may cancel the registration or take such other action, including extension of applicable time periods, as may be necessary to enable reregistration of such pesticide by another person.
(B)-
(i) If-
(I) no registrant of a pesticide containing an active ingredient listed under subsection (c)(2) notifies the Administrator under paragraph (2) that the registrant intends to seek reregistration of any pesticide containing that active ingredient;
(II) no such registrant complies with paragraph I
(III) no such registrant makes a commitment under paragraph (3)(B) to replace or submit all data described in clauses (ii) and (iii) of paragraph (3)(A); the Administrator shall publish in the Federal Register a notice of intent to remove the active ingredient from the list established under subsection (c)(2) and a notice of intent to cancel the registrations of all pesticides containing such active ingredient and shall provide 60 days for comment on such notice.
(ii) After the 60-day period has expired, the Administrator, by order, may cancel any such registration without hearing, except that the Administrator shall not cancel a registration under this subparagraph if-
(I) during the comment period a person acquires the rights of the registrant in that registration;
(II) during the comment period that person furnishes a notice of intent to reregister the pesticide in accordance with paragraph (2); and
(III) not later than 120 days after the publication of the notice under this subparagraph, that person has complied with paragraph (3) and the fee prescribed by subsection (i)(1) has been paid.
(6) SUSPENSIONS AND PENALTIES.- The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by section 3(c)(2)(B)(iv) if the Administrator determines that (A) progress is insufficient to ensure the submission of the data required for such pesticide under a commitment made under paragraph (3)(B) within the time period prescribed by paragraph (4)(B) or (B) the registrant has not submitted such data to the Administrator within such time period.
(e) PHASE THREE.-
(1) INFORMATION ABOUT STUDIES.- Each registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) who has submitted a notice under subsection (d)(2) of an intent to seek the reregisration of such pesticide shall submit, in accordance with the guidelines issued under paragraph (4), to the Administrator-
(A) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient and considered by the registrant to be adequate to meet the requirements of section 3 and the regulations issued under such section;
(B) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient that may not comply with the requirements of section 3 and the regulations issued under such section but which the registrant asserts should be deemed to comply with such requirements and regulations;
(C) a reformat of the data from each study summarized under subparagraph (A) or (B) by the registrant concerning chronic dosing, oncogenicity, reproductive effects, mutagenicity, neurotoxicity, teratogenicity, or residue chemistry of the active ingredient that were submitted to the Administrator before January 1, 1982;
(D) where data described in subparagraph (C) are not required for the active ingredient by regulations issued under section 3, a reformat of acute and subchronic dosing data submitted by the registrant to the Administrator before January 1, 1982, that the registrant considers to be adequate to meet the requirements of section 3 and the regulations issued under such section;
(E) an identification of data that are required to be submitted to the Administrator under section 6(a)(2) indicating an adverse effect of the pesticide;
(F) an identification of any other information available that in the view of the registrant supports the registration;
(G) a certification that the registrant or the Administrator possesses or has access to the raw data used in or generated by the studies that the registrant summarized under subparagraph (A) or (B);
(H) either-
(i) a commitment to submit data to fill each outstanding data requirement identified by the registrant; or
(ii) an offer to share in the cost of developing such data to be incurred by a person who has made a commitment under clause (i) to submit such data, and an offer to submit to arbitration as described by section 3(c)(2)(B) with regard to such cost sharing; and
(I) evidence of compliance with section 3(c)(1)(D)(ii) and regulations issued thereunder with regard to previously submitted data as if the registrant were now seeking the original registration of the pesticide.
A registrant who submits a certification under subparagraph (G) that is false shall be considered to have violated this Act and shall be subject to the penalties prescribed by section 14.
(2) TIME PERIODS.-
(A) The information required by paragraph (1) shall be submitted to the Administrator-
(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 12 months after the date of publication of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 12 months after the date of publication of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 12 months after the date of publication of the listing of such active ingredient.
(B) A registrant shall submit data in accordance with a commitment entered into under paragraph (1)(H) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment under such paragraph. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period.
(3) CANCELLATION.-
(A) If the registrant of a pesticide fails to submit the in formation required by paragraph (1) within the time prescribed by paragraph (2), the Administrator, by order and without hearing, shall cancel the registration of such pesticide.
(B)-
(i) If the registrant of a pesticide submits the information required by paragraph (1) within the time prescribed by paragraph (2) and such information does not conform to the guidelines for submissions established by the Administrator, the Administrator shall determine whether the registrant made a good faith attempt to conform its submission to such guidelines.
(ii) If the Administrator determines that the registrant made a good faith attempt to conform its submission to such guidelines, the Administrator shall provide the registrant a reasonable period of time to make any necessary changes or corrections.
(iii)-
(I) If the Administrator determines that the registrant did not make a good faith attempt to conform its submission to such guidelines, the Administrator may issue a notice of intent to cancel the registration. Such a notice shall be sent to the registrant by certified mail.
(II) The registration shall be canceled without a hearing or further notice at the end of 30 days after receipt by the registrant of the notice unless during that time a request for a hearing is made by the registrant.
(III) If a hearing is requested, a hearing shall be conducted under section 6(d), except that the only matter for resolution at the hearing shall be whether the registrant made a good faith attempt to conform its submission to such guidelines. The hearing shall be held and a determination made within 75 days after receipt of a request for hearing.
(4) GUIDELINES.-
(A) Not later than 1 year after the effective date of this section [December 24, 1988], the Administrator, by order, shall issue guidelines to be followed by registrants in-
(i) summarizing studies;
(ii) reformatting studies;
(iii) identifying adverse information; and
(iv) identifying studies that have been submitted previously that may not meet the requirements of section 3 or regulations issued under such section, under paragraph (1).
(B) Guidelines issued under subparagraph (A) shall not be subject to judicial review.
(5) MONITORING.- The Administrator shall monitor the progress of registrants in acquiring and submitting the data required under paragraph (1).
(f) PHASE FOUR.-
(1) INDEPENDENT REVIEW AND IDENTIFICATION OF OUTSTANDING DATA REQUIREMENTS.-
(A) The Administrator shall review the submissions of all registrants of pesticides containing a particular active ingredient under subsections (d)(3) and (e)(1) to determine if such submissions identified all the data that are missing or inadequate for such active ingredient. To assist the review of the Administrator under this subparagraph, the Administrator may require a registrant seeking reregistration to submit complete copies of studies summarized under subsection (e)(1).
(B) The Administrator shall independently identify and publish in the Federal Register the outstanding data requirements for each active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (C)(2) and that is contained in a pesticide to be reregistered under this section. The Administrator, at the same time, shall issue a notice under section 3(C)(2)(B) for the submission of the additional data that are required to meet such requirements.
(2) TIME PERIODS.-
(A) The Administrator shall take the action required by paragraph (1)-
(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B) not later than 18 months after the date of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C) not later than 24 months after the date of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D) not later than 33 months after the date of the listing of such active ingredient.
(B) If the Administrator issues a notice to a registrant under paragraph (1)(B) for the submission of additional data, the registrant shall submit such data within a reasonable period of time, as determined by the Administrator, but not to exceed 48 months after the issuance of such notice. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period.
(3) 4-1 SUSPENSIONS AND PENALTIES. - The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by section 3(C)(2)(B)(iv) if the Administrator determines that (A) tests necessary to fill an outstanding data requirement for such pesticide have not been initiated within 1 year after the issuance of a notice under paragraph (1)(B) or (B) progress is insufficient to ensure submission of the data referred to in clause (A) within the time period prescribed by paragraph (2)(B) or the required data have not been submitted to the Administrator within such time period.
__________
4-1. So in original. Margin of paragraph (3) should be aligned with margin of preceding paragraph (2).
(g) PHASE FIVE.-
(1) DATA REVIEW.- The Administrator shall conduct a thorough examination of all data submitted under this section concerning an active ingredient listed under subsection (c)(2) and of all other available data found by the Administrator to be relevant.
(2) REREGISTRATION AND OTHER ACTIONS.-
(A) Within 1 year after the submission of all data concerning an active ingredient of a pesticide under subsection (f), the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration. For extraordinary circumstances, the Administrator may extend such period for not more than 1 additional year.
(B) Before reregistering a pesticide, the Administrator shall obtain any needed product-specific data regarding the pesticide by use of section 3(c)(2)(B) and shall review such data within 90 days after its submission. The Administrator shall require that data under this subparagraph be submitted to the Administrator not later than 8 months after a determination of eligibility under subparagraph (A) has been made for each active ingredient of the pesticide, unless the Administrator determines that a longer period is required for the generation of the data.
(C) After conducting the review required by paragraph (1) for each active ingredient of a pesticide and the renew required by subparagraph (B) of this paragraph, the Administrator shall determine whether to reregister a pesticide by determining whether such pesticide meets the requirements of section 3(c)(5). If the Administrator determines that a pesticide is eligible to be reregistered, the Administrator shall reregister such pesticide within 6 months after the submission of the data concerning such pesticide under subparagraph (B).
(D) If after conducting a review under paragraph (1) or subparagraph (B) of this paragraph the Administrator determines that a pesticide should not be reregistered, the Administrator shall take appropriate regulatory action.
(h) COMPENSATION OF DATA SUBMITTER. - If data that are submitted by a registrant under subsection (d), (e), (f), or (g) are used to support the application of another person under section 3, the registrant who submitted such data shall be entitled to compensation for the use of such data as prescribed by section 3(c)(1)(D). In determining the amount of such compensation, the fees paid by the registrant under this section shall be taken into account.
(i) FEES.-
(1) INITIAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS. - The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $50,000 on submission of information under paragraphs (2) and (3) of subsection (d) for such ingredient.
(2) FINAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS.-
(A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $100,000-
(i) on submission of information for such ingredient under subsection (e)(1) if data are reformatted under subsection (e)(l)(C); or
(ii) on submission of data for such ingredient under subsection (e)(2)(B) if data are not reformatted under subsection (e)(1)(C).
(B) The registrants of pesticides that contain an active ingredient that is listed under subsection (c)(2)(A) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $150,000 at such time as the Administrator shall prescribe.
(3) FEES FOR OTHER PESTICIDE ACTIVE INGREDIENTS.-
(A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is not an active ingredient of any pesticide registered for a major food or feed use shall collectively pay fees in amounts determined by the Administrator. Such fees may not be less than one-half of, nor greater than, the fees required by paragraphs (1) and (2). A registrant shall pay such fees at the times corresponding to the times fees prescribed by paragraphs (1) and (2) are to be paid.
(B) The registrants of pesticides that contain an active ingredient that is listed under subsection (c)(2)(A) and that is not an active ingredient of any pesticide that is registered for a major food or feed use shall collectively pay a fee of not more than $100,000 and not less than $50,000 at such time as the Administrator shall prescribe.
(4) REDUCTION OR WAIVER OF FEES FOR MINOR USE AND OTHER PESTICIDES.-
(A) All active ingredient that is contained only in pesticides that are registered solely for agricultural or nonagricultural minor uses, or a pesticide the value or volume of use of which is small, shall be exempt from the fees prescribed by paragraph (3).
(B) An antimicrobial active ingredient, the production level of which does not exceed 1,000,000 pounds per year, shall be exempt from the fees prescribed by paragraph (3). For purposes of this subparagraph, the term "antimicrobial active ingredient" means any active ingredient that is contained only in pesticides that are not registered for any food or feed use and that are-
(i) sanitizers intended to reduce the number of living bacteria or viable virus particles on inanimate surface or in water or air;
(ii) bacteriostats intended to inhibit the growth of bacteria in the presence of moisture;
(iii) disinfectants intended to destroy or irreversibly inactivate bacteria, fungi, or viruses on surfaces or in animate objects;
(iv) sterilizers intended to destroy viruses and all living bacteria, fungi, and their spores on inanimate surfaces; or
(v) fungicides or fungistats.
(C)-
(i) Notwithstanding any other provision of this subsection, in the case of a small business registrant of a pesticide, the registrant shall pay a fee for the reregistration of each active ingredient of the pesticide that does not exceed an amount determined in accordance with this subparagraph.
(ii) If during the 3-year period prior to reregistration the average annual gross revenue of the registrant from pesticides containing such active ingredient is-
(I) less than $5,000,000, the registrant shall pay 0.5 percent of such revenue;
(II) $5,000,000 or more but less than $10,000,000, the registrant shall pay 1 percent of such revenue; or
(III) $10,000,000 or more, the registrant shall pay 1.5 percent of such revenue, but not more than $150,000.
(iii) For the purpose of this subparagraph, a small business registrant is a corporation, partnership, or unincorporated business that-
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to reregistration, had an average annual gross revenue from chemicals that did not exceed $40,000,000.
(5) MAINTENANCE FEE.-
(A) Subject to other provisions of this paragraph, each registrant of a pesticide shall pay an annual fee by March 1 of each year of-
(i) in the case of a registrant holding not more than 50 pesticide registrations, $425 for each registration; and
(ii) in the case of a registrant holding more than 50 pesticide registrations-
(I) $425 for each registration up to 50 registrations; and
(II) $100 for each registration over 50 registrations, except that no fee shall be charged for more than 200 registrations held by any registrant.
(B) The amount of each fee prescribed under subparagraph (A) shall be adjusted by the Administrator to a level that will result in the collection under this paragraph of, to the extent practicable, an aggregate amount of $14,000,000 each fiscal year.
(C)-
(i) The maximum annual fee payable by a registrant under clause (i) of subparagraph (A) (as adjusted under subparagraph (B)) shall be $20,000.
(ii) The maximum annual fee payable by a registrant under clause (ii) of subparagraph (A) (as adjusted under subparagraph (B)) shall be $35,000.
(D) If any fee prescribed by this paragraph with respect to the registration of a pesticide is not paid by a registrant by the time prescribed, the Administrator, by order and without hearing, may cancel the registration.
(E) The authority provided under this paragraph shall terminate on September 30, 1997.
(6) OTHER FEES. - During the period beginning on the date of enactment of this section [October 25, 1988] and ending on September 30, 1997, the Administrator may not levy any other fees for the registration of a pesticide under this Act except as provided in paragraphs (1) through (5).
(7) APPORTIONMENT.-
(A) If two or more registrants are required to pay any fee prescribed by paragraph (1), (2), or (3) with respect to a particular active ingredient, the fees for such active ingredient shall be apportioned among such registrants on the basis of the market share in United States sales of the active ingredient for the 3 calendar years preceding the date of payment of such fee, except that-
(i) small business registrants that produce the active ingredient shall pay fees in accordance with paragraph (4)(C); and
(ii) registrants who have no market share but who choose to reregister a pesticide containing such active ingredient shall pay the lesser of-
(I) 15 percent of the reregistration fee; or
(II) a proportionate amount of such fee based on the lowest percentage market share held by any registrant active in the marketplace.
In no event shall registrants who have no market share but who choose to reregister a pesticide containing such active ingredient collectively pay more than 25 percent of the total active ingredient reregistration fee.
(B) The Administrator, by order, may require any registrant to submit such reports as the Administrator determines to be necessary to allow the Administrator to determine and apportion fees under this subsection or to determine the registrant's eligibility for a reduction or waiver of a fee.
(C) If any such report is not submitted by a registrant after receiving notice of such report requirement, or if any fee prescribed by this subsection (other than paragraph (5)) for an active ingredient is not paid by a registrant to the Administrator by the time prescribed under this subsection, the Administrator, by order and without hearing, may cancel each registration held by such registrant of a pesticide containing the active ingredient with respect to which the fee is imposed. The Administrator shall reapportion the fee among the remaining registrants and notify the registrants that the registrants are required to pay to the Administrator any unpaid balance of the fee within 30 days after receipt of such notice.
(j) EXEMPTION OF CERTAIN REGISTRANTS. - The requirements of subsections (d), (e), (f), and (i) (other than subsection (i)(5)) regarding data concerning an active ingredient and fees for review of such data shall not apply to any person who is the registrant of a pesticide to the extent that, under section 3(c)(2)(D), the person would not be required to submit or cite such data to obtain an initial registration of such pesticide.
(k) REREGISTRATION AND EXPEDITED PROCESSING FUND.-
(1) ESTABLISHMENT. - There shall be established in the Treasury of the United States a reregistration and expedited processing fund.
(2) SOURCE AND USE. - All fees collected by the Administrator under subsection (i) shall be deposited into the fund and shall be available to the Administrator, without fiscal year limitation, to carry out reregistration and expedited processing of similar applications.
(3) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.-
(A) The Administrator shall use each fiscal year not more than $2,000,000 of the amounts in the fund to obtain sufficient personnel and resources to assure the expedited processing and review of any application that-
(i) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from any such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment; or
(ii) proposes an amendment to the registration of a registered pesticide that does not require scientific renew of data.
(B) Any amounts made available under subparagraph (A) shall be used to obtain sufficient personnel and resources to carry out the activities described in such subparagraph that are in addition to the personnel and resources available to carry out such activities on the date of enactment of this section [October 25, 1988].
(4) UNUSED FUNDS. - Money in the fund not currently needed to carry out this section shall be-
(A) maintained on hand or on deposit;
(B) invested in obligations of the United States or guaranteed thereby; or
(C) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.
(5) ACCOUNTING. - The Administrator shall-
(A) provide an annual accounting of the fees collected and disbursed from the fund; and
(B) take all steps necessary to ensure that expenditures from such fund are used only to carry out this section.
(l) JUDICIAL REVIEW. - Any failure of the Administrator to take any action required by this section shall be subject to judicial review under the procedures prescribed by section 16(b).
SEC. 5. [136c] EXPERIMENTAL USE PERMITS.
(a) ISSUANCE.-Any person may apply to the Administrator for an experimental use permit for a pesticide. The Administrator shall review the application. After completion of the review, but not later than one hundred and twenty days after receipt of the application and all required supporting data, the Administrator shall either issue the permit or notify the applicant of the Administrator's determination not to issue the permit and the reasons therefor. The applicant may correct the application or request a waiver of the conditions for such permit within thirty days of receipt by the applicant of such notification. The Administrator may issue an experimental use permit only if the Administrator determines that the applicant needs such permit in order to accumulate information necessary to register a pesticide under section 3 of this Act. An application for an experimental use permit may be filed at any time.
(b) TEMPORARY TOLERANCE LEVEL. - If the Administrator determines that the use of a pesticide may reasonably be expected to result in any residue on or in food or feed, he may establish a temporary tolerance level for the residue of the pesticide before issuing the experimental use permit.
(c) USE UNDER PERMIT. - Use of a pesticide under an experimental use permit shall be under the supervision of the Administrator, and shall be subject to such terms and conditions and be for such period of time as the Administrator may prescribe in the permit.
(d) STUDIES. - When any experimental use permit is issued for a pesticide containing any chemical or combination of chemicals which has not been included in any previously registered pesticide, the Administrator may specify that studies be conducted to detect whether the use of the pesticide under the permit may cause unreasonable adverse effects on the environment. All results of such studies shall be reported to the Administrator before such pesticide may be registered under section 3.
(e) REVOCATION. - The Administrator may revoke any experimental use permit, at any time, if he finds that its terms or conditions are being violated, or that its terms and conditions are inadequate to avoid unreasonable adverse effects on the environment.
(f) STATE ISSUANCE OF PERMITS. - Notwithstanding the foregoing provisions of this section, the Administrator shall, under such terms and conditions as he may by regulations prescribe, authorize any State to issue an experimental use permit for a pesticide. All provisions of section 11 relating to State plans shall apply with equal force to a State plan for the issuance of experimental use permits under this section.
(g) EXEMPTION FOR AGRICULTURAL RESEARCH AGENCIES. -Notwithstanding the foregoing provisions of this section, the Administrator may issue an experimental use permit for a pesticide to any public or private agricultural research agency or educational institution which applies for such permit. Each permit shall not exceed more than a one-year period or such other specific time as the Administrator may prescribe. Such permit shall be issued under such terms and conditions restricting the use of the pesticide as the Administrator may require. Such pesticide may be used only by such research agency or educational institution for purposes of experimentation.
SEC. 6. [136d] ADMINISTRATIVE REVIEW; SUSPENSION.
(a) CANCELLATION AFTER FIVE YEARS-
(1) PROCEDURE. - The Administrator shall cancel the registration of any pesticide at the end of the five-year period which begins on the date of its registration (or at the end of any five-year period thereafter) unless the registrant, or other interested person with the concurrence of the registrant, before the end of such period, requests in accordance with regulations prescribed by the Administrator that the registration be continued in effect. The Administrator may permit the continued sale and use of existing stocks of a pesticide whose registration is canceled under this subsection or subsection (b) to such extent, under such conditions, and for such uses as he may specify if he determines that such sale or use is not inconsistent with the purposes of this Act and will not have unreasonable adverse effects on the environment. The Administrator shall publish in the Federal Register, at least 30 days prior to the expiration of such five-year period, notice that the registration will be canceled if the registrant or other interested person with the concurrence of the registrant does not request that the registration be continued in effect.
(2) INFORMATION. - If at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shall submit such information to the Administrator.
(b) CANCELLATION AND CHANGE IN CLASSIFICATION. - If it appears to the Administrator that a pesticide or its labeling or other material required to be submitted does not comply with the provisions of this Act or, when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment, the Administrator may issue a notice of his intent either-
(1) to cancel its registration or to change its classification together with the reasons (including the factual basis) for his action, or
(2) to hold a hearing to determine whether or not its registration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In determining whether to issue any such notice, the Administrator shall include among those factors to be taken into account the impact of the action proposed in such notice on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy. At least 60 days prior to sending such notice to the registrant or making public such notice, whichever occurs first, the Administrator shall provide the Secretary of Agriculture with a copy of such notice and an analysis of such impact on the agricultural economy. If the Secretary comments in writing to the Administrator regarding the notice and analysis within 30 days after receiving them, the Administrator shall publish in the Federal Register (with the notice) the comments of the Secretary and the response of the Administrator with regard to the Secretary's comments. If the Secretary does not comment in writing to the Administrator regarding the notice and analysis within 30 days after receiving them, the Administrator may notify the registrant and make public the notice at any time after such 30-day period notwithstanding the foregoing 60-day time requirement. The time requirements imposed by the preceding 3 sentences may be waived or modified to the extent agreed upon by the Administrator and the Secretary. Notwithstanding any other provision of this subsection (b) and section 25(d), in the event that the Administrator determines that suspension of a pesticide registration is necessary to prevent an imminent hazard to human health, then upon such a finding the Administrator may waive the requirement of notice to and consultation with the Secretary of Agriculture pursuant to subsection (b) and of submission to the Scientific Advisory Panel pursuant to section 25(d) and proceed in accordance with subsection (c). The proposed action shall become final and effective at the end of 30 days from receipt by the registrant, or publication, of a notice issued under paragraph (1), whichever occurs later, unless within that time either (i) the registrant makes the necessary corrections, if possible, or (ii) a request for a hearing is made by a person adversely affected by the notice. In the event a hearing is held pursuant to such a request or to the Administrator's determination under paragraph (2), a decision pertaining to registration or classification issued after completion of such hearing shall be final. In taking any final action under this subsection, the Administrator shall consider restricting a pesticide's use or uses as an alternative to cancellation and shall fully explain the reasons for these restrictions, and shall include among those factors to be taken into account the impact of such final action on production and prices of agricultural commodities, retail food prices, and otherwise on the agricultural economy, and he shall publish in the Federal Register an analysis of such impact.
(c) SUSPENSION.-
(1) ORDER. - If the Administrator determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings, he may, by order, suspend the registration of the pesticide immediately. No order of suspension may be issued unless the Administrator has issued or at the same time issues notice of his intention to cancel the registration or change the classification of the pesticide. Except as provided in paragraph (3), the Administrator shall notify the registrant prior to issuing any suspension order. Such notice shall include findings pertaining to the question of "imminent hazard". The registrant shall then have an opportunity, in accordance with the provisions of paragraph (2), for an expedited hearing before the Administrator on the question of whether an imminent hazard exists.
(2) EXPEDITE HEARING. - If no request for a hearing is submit ted to the Administrator within five days of the registrant's receipt of the notification provided for by paragraph (1), the suspension order may be issued and shall take effect and shall not be reviewable by a court. If a hearing is requested, it shall commence within five days of the receipt of the request for such hearing unless the registrant and the Administrator - agree that it shall commence at a later time. The hearing shall be held in accordance with the provisions of subchapter II of title 5 of the United States Code, except that the presiding officer need not be a certified hearing examiner. The presiding officer shall have ten days from the conclusion of the presentation of evidence to submit recommended findings and conclusions to the Administrator, who shall then have seven days to render a final order on the issue of suspension.
(3) EMERGENCY ORDER. - Whenever the Administrator deter mines that an emergency exists that does not permit him to hold a hearing before suspending, he may issue a suspension order in advance of notification to the registrant. In that case, paragraph (2) shall apply except that (A) the order of suspension shall be in effect pending the expeditious completion of the remedies provided by that paragraph and the issuance of a final order on suspension, and (B) no party other than the registrant and the Administrator shall participate except that any person adversely affected may file briefs within the time allot ted by the Administrator's rules. Any person so filing briefs shall be considered a party to such proceeding for the purposes of section 16(b).
(4) JUDICIAL REVIEW. - A final order on the question of suspension following a hearing shall be reviewable in accordance with Section 16 of this Act, notwithstanding the fact that any related cancellation proceedings have not been completed. Any order of suspension entered prior to a hearing before the Administrator shall be subject to immediate review in an action by the registrant or other interested person with the concurrence of the registrant in an appropriate district court, solely to determine whether the order of. suspension was arbitrary, capricious or an abuse of discretion, or whether the order was issued in accordance with the procedures established by law. The effect of any order of the court will be only to stay the effectiveness of the suspension order, pending the Administrator's final decision with respect to cancellation or change in classification. This action may be maintained simultaneously with any administrative review proceeding under this section. The commencement of proceedings under this paragraph shall not operate as a stay of order, unless ordered by the court.
(d) PUBLIC HEARINGS AND SCIENTIFIC REVIEW. - In the event a hearing is requested pursuant to subsection (b) or determined upon - by the Administrator pursuant to subsection (b), such hearing shall be held after due notice for the purpose of receiving evidence relevant and material to the issues raised by the