United States 730L97001
Environmental Protection March 1997
Agency
Office of Pesticide Programs
V>EPA The Federal Insecticide,
Fungicide, and Rodenticide
Act (FIFRA) and Federal
Food, Drug, and Cosmetic
Act (FFDCA) As Amended
by the Food Quality
Protection Act (FQPA) of
August 3,1996
-------
CONTENTS
Page
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT
1. Short title and table of contents 3
2. Definitions 7
3. Registration of pesticides 16
4. Reregistration of registered pesticides 36
5. Experimental use permits 58
6. Administrative review; suspension 59
7. Registration of establishments 65
8. Books and records 66
9. Inspection of establishments, etc 67
10. Protection of trade secrets and other information 68
11. Use of restricted use pesticides; applicators 71
12. Unlawful acts 73
13. Stop sale, use, removal, and seizure 75
14. Penalties 77
15. Indemnities 78
16. Administrative procedure; judicial review 81
17. Imports and exports 81
18. Exemption of Federal and State agencies 82
19. Storage, disposal, transportation, and recall 83
20. Research and monitoring 88
21. Solicitation of comments; notice of public hearings 88
22. Delegation and cooperation 88
23. State cooperation, aid, and training 89
24. Authority of States 89
25. Authority of Administrator 90
26. State primary enforcement responsibility 94
27. Failure by the State to assure enforcement of State pesticide use
regulations 95
28. Identification of pests; cooperation with Department of Agriculture's
program 96
29. Annual report 96
30. Minimum requirements for training of maintenance applicators and
service technicians 97
31. Environmental Protection Agency minor use program 97
32. Department of Agriculture minor use program 97
33. Severability 98
34. Authorization for appropriations 98
FEDERAL FOOD, DRUG, AND COSMETIC ACT (TITLES i THROUGH rvo
Chapter I—Short title 101
Chapter II—Definitions 102
Chapter III—Prohibited acts and penalties 110
Chapter IV—Food 135
-------
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE
ACT
-------
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE
ACT
(References [ ] in brackets are to title 7, United States Code)
(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 Insec-
ticide, Fungicide, and Rodenticide Act".
(b) TABLE OF CONTENTS.—x
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.
(j) Environment.
(k) Fungus.
(1) 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.
1 So in original. The table of contents does not correspond to the contents of the Act. Public
Law 104-170 did not make conforming amendments to the table of contents.
-------
Sec. 1 FIFRA 4
(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.
(l)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.
-------
5 FIFRA Sec. 1
(3) Expedited processing of similar applications.
(4) Unused funds.
(5) Accounting.
(1) 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.
(3) Transfer of registration of pesticides registered for minor agricultural
uses.
(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.
-------
Sec. 1 FIFRA
(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.
-------
7 FIFRA Sec. 2
(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.
(a) In general.
(b) Pest control availability.
(1) In general.
(2) Report.
(c) Integrated pest management.
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, desiccant, or nitrogen stabilizer, 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;
-------
Sec. 2 FIFRA 8
(4) in the case of a desiccant, an ingredient which will arti-
ficially accelerate the drying of plant tissue; and
(5) in the case of a nitrogen stabilizer, an ingredient which
will prevent or hinder the process of nitrification,
denitrification, ammonia volatilization, or urease production
through action affecting soil bacteria.
(b) ADMINISTRATOR.—The term "Administrator" means the Ad-
ministrator of the Environmental Protection Agency.
(c) ADULTERATED.—The term "adulterated" applies to any pes-
ticide 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 in-
vertebrate 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 11 as au-
thorized to use or supervise the use of any pesticide which is
classified for restricted use. Any applicator who holds or ap-
plies registered pesticides, or uses dilutions of registered pes-
ticides consistent with subsection (ee), 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 distribu-
tor of pesticides under this Act.
(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 the applicator or the applicator's employer or (if ap-
plied 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 ap-
plicator" means an applicator (whether or not the applicator is
a private applicator with respect to some uses) who uses or su-
pervises the use of any pesticide which is classified for re-
stricted use for any purpose or on any property other than as
provided by paragraph (2).
(4) UNDER THE DIRECT SUPERVISION OF A CERTIFIED APPLI-
CATOR.—Unless otherwise prescribed by its labeling, a pes-
ticide shall be considered to be applied under the direct super-
vision 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.
-------
9 FIFRA Sec. 2
(g) DESICCANT.—The term "desiccant" means any substance or
mixture of substances intended for artificially accelerating the dry-
ing of plant tissue.
(h) DEVICE.—The term "device" means any instrument or con-
trivance (other than a firearm) which is intended for trapping, de-
stroying, 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 ani-
mals); but not including equipment used for the application of pes-
ticides 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 liv-
ing man or other animals and those on or in processed food, bev-
erages, or pharmaceuticals.
(1) 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 re-
sult in unreasonable adverse effects on the environment or will in-
volve unreasonable hazard to the survival of a species declared en-
dangered 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 state-
ment of the percentages of total and water soluble arsenic, cal-
culated 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 exam-
ple, 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—
-------
Sec. 2 FIFRA 10
(A) accompanying the pesticide or device at any time;
or
(B) to which reference is made on the label or in lit-
erature accompanying the pesticide or device, except to
current official publications of the Environmental Protec-
tion Agency, the United States Departments of Agriculture
and Interior, the Department of Health and Human Serv-
ices, 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 pes-
ticides.
(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 estab-
lished 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 as-
signed 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 con-
spicuousness (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 pur-
chase and use;
(F) the labeling accompanying it does not contain di-
rections for use which are necessary for effecting the pur-
pose for which the product is intended and if complied
with, together with any requirements imposed under sec-
tion 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 environ-
ment; or
(H) in the case of a pesticide not registered in accord-
ance with section 3 of this Act and intended for export, the
label does not contain, in words prominently placed there-
on with such conspicuousness (as compared with other
words, statements, designs, or graphic matter in the label-
ing) as to render it likely to be noted by the ordinary indi-
vidual 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—
-------
11 FIFRA Sec. 2
(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 dis-
played under customary conditions of purchase, except
that a pesticide is not misbranded under this subpara-
graph if—
(i) the size or form of the immediate container, or
the outside container or wrapper of the retail package,
makes it impracticable to place the ingredient state-
ment 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 out-
side container or wrapper of the retail package, if there be
one, through which the required information on the imme-
diate container cannot be clearly read, a label bearing—
(i) the name and address of the producer, reg-
istrant, 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, ex-
cept that the Administrator may permit reasonable
variations; and
(iv) when required by regulation of the Adminis-
trator to effectuate the purposes of this Act, the reg-
istration 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 ani-
mals of the phylum nemathelminth.es and class nematoda, that is,
unsegmented round worms with elongated, fusiform, or saclike bod-
ies 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, partner-
ship, association, corporation, or any organized group of persons
whether incorporated or not.
(t) PEST.—The term "pest" means (1) any insect, rodent, nema-
tode, fungus, weed, or (2) any other form of terrestrial or aquatic
plant or animal life or virus, bacteria, or other micro-organism (ex-
cept viruses, bacteria, or other micro-organisms on or in living man
-------
Sec. 2 FIFRA 12
or other living animals) which the Administrator declares to be a
pest under section 25(c)(l).
(u) PESTICIDE.—The term "pesticide" means (1) any substance
or mixture of substances intended for preventing, destroying, repel-
ling, or mitigating any pest, (2) any substance or mixture of sub-
stances intended for use as a plant regulator, defoliant, or des-
iccant, and (3) any nitrogen stabilizer, except that the term "pes-
ticide" 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 ani-
mal drug by a regulation establishing conditions of use for the arti-
cle, 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. The term "pesticide" does not include liquid chemical
sterilant products (including any sterilant or subordinate disinfect-
ant claims on such products) for use on a critical or semi-critical
device, as defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321). For purposes of the preceding sen-
tence, the term "critical device" includes any device which is intro-
duced directly into the human body, either into or in contact with
the bloodstream or normally sterile areas of the body and the term
"semi-critical device" includes any device which contacts intact mu-
cous membranes but which does not ordinarily penetrate the blood
barrier or otherwise enter normally sterile areas of the body.
(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 im-
provement, maintenance, survival, health, and propagation of
plants, and as are not for pest destruction and are nontoxic, non-
poisonous 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 pro-
ducing a pesticide. The term "produce" means to manufacture, pre-
pare, compound, propagate, or process any pesticide or device or ac-
tive ingredient used in producing a pesticide. The dilution by indi-
viduals 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 "pro-
tect 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.
-------
13 FIFRA Sec. 2
(z) REGISTRATION.—The term "registration" includes reregistra-
tion.
(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 ENVIRON-
MENT.—The term "unreasonable adverse effects on the environ-
ment" means (1) 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, or (2) a human dietary risk
from residues that result from a use of a pesticide in or on any food
inconsistent with the standard under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a)./l/ The Adminis-
trator shall consider the risks and benefits of public health pes-
ticides separate from the risks and benefits of other pesticides. In
weighing any regulatory action concerning a public health pesticide
under this Act, the Administrator shall weigh any risks of the pes-
ticide against the health risks such as the diseases transmitted by
the vector to be controlled by the 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 pro-
ducing a pesticide is produced, or held, for distribution or sale.
(ee) To USE ANY REGISTERED PESTICIDE IN A MANNER INCON-
SISTENT WITH ITS LABELING.—The term "to use any registered pes-
ticide in a manner inconsistent with its labeling" means to use any
registered pesticide in a manner not permitted by the labeling, ex-
cept 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 pes-
ticide 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 ap-
plication not prohibited by the labeling unless the labeling specifi-
cally 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 Admin-
istrator determines to be consistent with the purposes of this Act.
After March 31, 1979, the term shall not include the use of a pes-
ticide for agricultural or forestry purposes at a dilution less than
label dosage unless before or after that date the Administrator is-
sues a regulation or advisory opinion consistent with the study pro-
'Sec. 304 of P.L. 104-170 amended sec. 2(bb) (7 U.S.C. 136(bb)) by inserting "(1)" and ", or
(2)" and all that follows through "346a).", without specifying the Act that was being amended.
The amendments were executed to this Act to effectuate the probable intent of Congress.
-------
Sec. 2 FIFRA 14
vided 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 require-
ment" 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 Adminis-
trator 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 is-
sued 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 deter-
mine 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 de-
liver. The term does not include the holding or application of reg-
istered 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.
(hh) NITROGEN STABILIZER.—The term "nitrogen stabilizer"
means any substance or mixture of substances intended for pre-
venting or hindering the process of nitrification, denitrification,
ammonia volatilization, or urease production through action upon
soil bacteria. Such term shall not include—
(1) dicyandiamide;
(2) ammonium thiosulfate; or
(3) any substance or mixture of substances.—
(A) that was not registered pursuant to section 3 prior
to January 1, 1992; and
(B) that was in commercial agronomic use prior to
January 1, 1992, with respect to which after January 1,
1992, the distributor or seller of the substance or mixture
has made no specific claim of prevention or hindering of
the process of nitrification, denitrification, ammonia vola-
tilization urease production regardless of the actual use or
purpose for, or future use or purpose for, the substance or
mixture.
Statements made in materials required to be submitted to any
State legislative or regulatory authority, or required by such au-
thority to be included in the labeling or other literature accompany-
ing any such substance or mixture shall not be deemed a specific
claim within the meaning of this subsection.
-------
15 FIFRA Sec. 2
(jj)1 MAINTENANCE APPLICATOR.—The term "maintenance ap-
plicator" means any individual who, in the principal course of such
individual's employment, uses, or supervises the use of, a pesticide
not classified for restricted use (other than a ready to use consumer
products pesticide); for the purpose of providing structural pest
control or lawn pest control including janitors, general mainte-
nance personnel, sanitation personnel, and grounds maintenance
personnel. The term 'maintenance applicator" does not include pri-
vate applicators as defined in section 2(e)(2); individuals who use
antimicrobial pesticides, sanitizers or disinfectants; individuals em-
ployed by Federal, State, and local governments or any political
subdivisions thereof, or individuals who use pesticides not classi-
fied for restricted use in or around then* homes, boats, sod farms,
nurseries, greenhouses, or other noncommercial property.
(kk) SERVICE TECHNICIAN.—The term "service technician"
means any individual who uses or supervises the use of pesticides
(other than a ready to use consumer products pesticide) for the
purpose of providing structural pest control or lawn pest control on
the property of another for a fee. The term "service technician"
does not include individuals who use antimicrobial pesticides, sani-
tizers or disinfectants; or who otherwise apply ready to use
consumer products pesticides.
(11) MINOR USE.—The term "minor use" means the use of a pes-
ticide on an animal, on a commercial agricultural crop or site, or
for the protection of public health where—
(1) the total United States acreage for the crop is less than
300,000 acres, as determined by the Secretary of Agriculture;
or
(2) the Administrator, in consultation with the Secretary of
Agriculture, determines that, based on information provided by
an applicant for registration or a registrant, the use does not
provide sufficient economic incentive to support the initial reg-
istration or continuing registration of a pesticide for such use
and—
(A) there are insufficient efficacious alternative reg-
istered pesticides available for the use;
(B) the alternatives to the pesticide use pose greater
risks to the environment or human health;
(C) the minor use pesticide plays or will play a signifi-
cant part in managing pest resistance; or
(D) the minor use pesticide plays or will play a signifi-
cant part in an integrated pest management program.
The status as a minor use under this subsection shall continue as
long as the Administrator has not determined that, based on exist-
ing data, such use may cause an unreasonable adverse effect on the
environment and the use otherwise qualifies for such status.
(mm) ANTIMICROBIAL PESTICIDE.—
(1) IN GENERAL.—The term "antimicrobial pesticide" means
a pesticide that—
(A) is intended to—
'So in original (as added by sec. 120 of P.L. 104-170). This subsection should probably be
"(ii)" and subsequent subsections should be redesignated accordingly.
-------
Sec. 3 FIFRA IB
(i) disinfect, sanitize, reduce, or mitigate growth
or development of microbiological organisms; or
(ii) protect inanimate objects, industrial processes
or systems, surfaces, water, or other chemical sub-
stances from contamination, fouling, or deterioration
caused by bacteria, viruses, fungi, protozoa, algae, or
slime; and
(B) in the intended use is exempt from, or otherwise
not subject to, a tolerance under section 408 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or
a food additive regulation under section 409 of such Act.
(2) EXCLUDED PRODUCTS.—The term "antimicrobial pes-
ticide" does not include —
(A) a wood preservative or antifouling paint product
for which a claim of pesticidal activity other than or in ad-
dition to an activity described in paragraph (1) is made;
(B) an agricultural fungicide product; or
(C) an aquatic herbicide product.
(3) INCLUDED PRODUCTS.—The term "antimicrobial pes-
ticide" does include any other chemical sterilant product (other
than liquid chemical sterilant products exempt under sub-
section (u)), any other disinfectant product, any other indus-
trial microbiocide product, and any other preservative product
that is not excluded by paragraph (2).
(nn) PUBLIC HEALTH PESTICIDE.—The term "public health pes-
ticide" means any minor use pesticide product registered for use
and used predominantly in public health programs for vector con-
trol or for other recognized health protection uses, including the
prevention or mitigation of viruses, bacteria, or other microorga-
nisms (other than viruses, bacteria, or other microorganisms on or
in living man or other living animal) that pose a threat to public
health.
(oo) VECTOR.—The term "vector" means any organism capable
of transmitting the causative agent of human disease or capable of
producing human discomfort or injury, including mosquitoes, flies,
fleas, cockroaches, or other insects and ticks, mites, or rats.
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 per-
son any pesticide that is not registered under this Act. To the ex-
tent necessary to prevent unreasonable adverse effects on the envi-
ronment, the Administrator may by regulation limit the distribu-
tion, 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 an-
other 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
-------
17 FIFRA Sec. 3
(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 direc-
tions for its use;
(D) the complete formula of the pesticide;
(E) a request that the pesticide be classified for gen-
eral use or for restricted use, or for both; and
(F) 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 sub-
mitted to the Administrator and that the Administrator
may consider in accordance with the following provisions:
(i) With respect to pesticides containing active in-
gredients that are initially registered under this Act
after the date of enactment of the Federal Pesticide
Act of 1978, data submitted to support the application
for the original registration of the pesticide, or an ap-
plication 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 origi-
nal data submitter, be considered by the Adminis-
trator to support an application by another person
during a period of ten years following the date the Ad-
ministrator first registers the pesticide, except that
such permission shall not be required in the case of
defensive data.
(ii) The period of exclusive data use provided
under clause (i) shall be extended 1 additional year for
each 3 minor uses registered after the date of enact-
ment of this clause and within 7 years of the com-
mencement of the exclusive use period, up to a total
of 3 additional years for all minor uses registered by
the Administrator if the Administrator, in consultation
with the Secretary of Agriculture, determines that,
based on information provided by an applicant for reg-
istration or a registrant, that—
(I) there are insufficient efficacious alter-
native registered pesticides available for the use;
(II) the alternatives to the minor use pesticide
pose greater risks to the environment or human
health;
(III) the minor use pesticide plays or will play
a significant part in managing pest resistance; or
-------
Sec. 3 FIFRA 18
(IV) the minor use pesticide plays or will play
a significant part in an integrated pest manage-
ment program.
The registration of a pesticide for a minor use on a
crop grouping established by the Administrator shall
be considered for purposes of this clause 1 minor use
for each representative crop for which data are pro-
vided in the crop grouping. Any additional exclusive
use period under this clause shall be modified as ap-
propriate or terminated if the registrant voluntarily
cancels the product or deletes from the registration
the minor uses which formed the basis for the exten-
sion of the additional exclusive use period or if the Ad-
ministrator determines that the registrant is not actu-
ally marketing the product for such minor uses.
(iii) Except as otherwise provided in clause (i),
with respect to data submitted after December 31,
1969, by an applicant or registrant to support an ap-
plication for registration, experimental use permit, or
amendment adding a new use to an existing registra-
tion, to support or maintain in effect an existing reg-
istration, or for reregistration, the Administrator may,
without the permission of the original data submitter,
consider any such item of data in support of an appli-
cation by any other person (hereinafter in this sub-
paragraph 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 accom-
panied by evidence of delivery to the original data sub-
mitter of the offer. The terms and amount of com-
pensation may be fixed by agreement between the
original data submitter and the applicant, or, failing
such agreement, binding arbitration under this sub-
paragraph. 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 ap-
plicant 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 proceed-
ings by requesting the Federal Mediation and Concil-
iation Service to appoint an arbitrator from the roster
of arbitrators maintained by such Service. The proce-
dure 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 juris-
diction to review any such findings and determination,
except for fraud, misrepresentation, or other mis-
conduct by one of the parties to the arbitration or the
arbitrator where there is a verified complaint with
-------
19 FIFRA Sec. 3
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 com-
pensation for the use of the data in support of the ap-
plication. 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 concern-
ing compensation under this subparagraph, the Ad-
ministrator 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 preced-
ing 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 re-
spond. If a registration is denied or canceled under
this subparagraph, the Administrator may make such
order as the Administrator deems appropriate con-
cerning the continued sale and use of existing stocks
of such pesticide. Registration action by the Adminis-
trator shall not be delayed pending the fixing of com-
pensation.
(iv) 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), (ii), and
(iii), 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 com-
pensate the original data submitter for the use of such
item of data.
(v) The period of exclusive use provided under
clause (ii) shall not take effect until 1 year after enact-
ment of this clause, except where an applicant or reg-
istrant is applying for the registration of a pesticide
containing an active ingredient not previously reg-
istered.
(vi) With respect to data submitted after the date
of enactment of this clause by an applicant or reg-
istrant to support an amendment adding a new use to
an existing registration that does not retain any pe-
riod of exclusive use, if such data relates solely to a
-------
Sec. 3 FIFRA 20
minor use of a pesticide, such data shall not, without
the written permission of the original data submitter,
be considered by the Administrator to support an ap-
plication for a minor use by another person during the
period of 10 years following the date of submission of
such data. The applicant or registrant at the time the
new minor use is requested shall notify the Adminis-
trator that to the best of their knowledge the exclusive
use period for the pesticide has expired and that the
data pertaining solely to the minor use of a pesticide
is eligible for the provisions of this paragraph. If the
minor use registration which is supported by data sub-
mitted pursuant to this subsection is voluntarily can-
celed or if such data are subsequently used to support
a nonminor use, the data shall no longer be subject to
the exclusive use provisions of this clause but shall in-
stead be considered by the Administrator in accord-
ance with the provisions of clause (i), as appropriate.
(G) If the applicant is requesting that the registration
or amendment to the registration of a pesticide be expe-
dited, an explanation of the basis for the request must be
submitted, in accordance with paragraph (10) of this sub-
section.
(2) DATA IN SUPPORT OF REGISTRATION.—
(A) IN GENERAL.—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
the Administrator requires any additional kind of informa-
tion under subparagraph (B) of this paragraph, the Admin-
istrator shall permit sufficient time for applicants to ob-
tain such additional information. The Administrator, in es-
tablishing standards for data requirements for the reg-
istration of pesticides with respect to minor uses, shall
make such standards commensurate with the anticipated
extent of use, pattern of use, the public health and agricul-
tural need for such minor use, and the level and degree of
potential beneficial or adverse effects on man and the envi-
ronment. The Administrator shall not require a person to
submit, in relation to a registration or reregistration of a
pesticide for minor agricultural use under this Act, any
field residue data from a geographic area where the pes-
ticide will not be registered for such use. In the develop-
ment 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 meet-
ing 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
the Administrator shall make available to the public the
data called for in the registration statement together with
such other scientific information as the Administrator
deems relevant to the Administrator's decision.
-------
21 FIFRA Sec. 3
(B) ADDITIONAL DATA.—(i) If the Administrator deter-
mines that additional data are required to maintain in ef-
fect an existing registration of a pesticide, the Adminis-
trator 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 evi-
dence 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 in-
tent 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 Ad-
ministrator of their agreement to develop jointly, or share
in the cost of developing data, the registrants have not fur-
ther agreed on the terms of the data development arrange-
ment or on a procedure for reaching such agreement, any
of such registrants may initiate binding arbitration pro-
ceedings by requesting the Federal Mediation and Concil-
iation 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, misrepresen-
tation, or other misconduct by one of the parties to the ar-
bitration or the arbitrator where there is a verified com-
plaint with supporting affidavits attesting to specific in-
stances of such fraud, misrepresentation, or other mis-
conduct. 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 proce-
dures prescribed by clause (iv) if a registrant fails to com-
ply 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 ap-
propriate steps to secure the data required under this sub-
paragraph, to participate in a procedure for reaching
agreement concerning a joint data development arrange-
ment under this subparagraph or in an arbitration pro-
ceeding as required by this subparagraph, or to comply
with the terms of an agreement or arbitration decision con-
-------
Sec. 3 FIFRA 22
cerning a joint data development arrangement under this
subparagraph, the Administrator may issue a notice of in-
tent to suspend such registrant's registration of the pes-
ticide for which additional data is required. The Adminis-
trator may include in the notice of intent to suspend such
provisions as the Administrator deems appropriate con-
cerning the continued sale and use of existing stocks of
such pesticide. Any suspension proposed under this sub-
paragraph 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 no-
tice 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 resolu-
tion 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 Ad-
ministrator'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 hear-
ing. Any registration suspended under this subparagraph
shall be reinstated by the Administrator if the Adminis-
trator determines that the registrant has complied fully
with the requirements that served as a basis for the sus-
pension 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 sub-
mission to handle any subsequent data compensation mat-
ters for the joint submitters of such data.
(vi) Upon the request of a registrant the Administrator
shall, in the case of a minor use, extend the deadline for
the production of residue chemistry data under this sub-
paragraph for data required solely to support that minor
use until the final deadline for submission of data under
section 4 for the other uses of the pesticide established as
of the date of enactment of the Food Quality Protection Act
of 1996, if—
(I) the data to support other uses of the pesticide
on a food are being provided;
(II) the registrant, in submitting a request for
such an extension, provides a schedule, including in-
terim dates to measure progress, to assure that the
data production will be completed before the expira-
tion of the extension period;
-------
23 FIFRA Sec. 3
(III) the Administrator has determined that such
extension will not significantly delay the Administra-
tor's schedule for issuing a reregistration eligibility de-
termination required under section 4; and
(IV) the Administrator has determined that based
on existing data, such extension would not signifi-
cantly increase the risk of any unreasonable adverse
effect on the environment.1 If the Administrator
grants an extension under this clause, the Adminis-
trator shall monitor the development of the data and
shall ensure that the registrant is meeting the sched-
ule for the production of the data. If the Administrator
determines that the registrant is not meeting or has
not met the schedule for the production of such data,
the Administrator may proceed in accordance with
clause (iv) regarding the continued registration of the
affected products with the minor use and shall inform
the public of such action. Notwithstanding the provi-
sions of this clause, the Administrator may take action
to modify or revoke the extension under this clause if
the Administrator determines that the extension for
the minor use may cause an unreasonable adverse ef-
fect on the environment. In such circumstance, the Ad-
ministrator shall provide, in writing to the registrant,
a notice revoking the extension of time for submission
of data. Such data shall instead be due in accordance
with the date established by the Administrator for the
submission of the data.
(vii) If the registrant does not commit to support a
specific minor use of the pesticide, but is supporting and
providing data in a timely and adequate fashion to support
uses of the pesticide on a food, or if all uses of the pes-
ticide are nonfood uses and the registrant does not commit
to support a specific minor use of the pesticide but is sup-
porting and providing data in a timely and adequate fash-
ion to support other nonfood uses of the pesticide, the Ad-
ministrator, at the written request of the registrant, shall
not take any action pursuant to this clause in regard to
such unsupported minor use until the final deadline estab-
lished as of the date of enactment of the Food Quality Pro-
tection Act of 1996, for the submission of data under sec-
tion 4 for the supported uses identified pursuant to this
clause unless the Administrator determines that the ab-
sence of the data is significant enough to cause human
health or environmental concerns. On the basis of such de-
termination, the Administrator may refuse the request for
extension by the registrant. Upon receipt of the request
from the registrant, the Administrator shall publish in the
Federal Register a notice of the receipt of the request and
the effective date upon which the uses not being supported
will be voluntarily deleted from the registration pursuant
'Indentation of the following sentences of this clause is so in original (as added by sec.
201(cXD of P.L. 104-170). Probably should be indented the same as flush matter of this clause.
-------
Sec. 3 FIFRA 24
to section 6(f)(l). If the Administrator grants an extension
under this clause, the Administrator shall monitor the de-
velopment of the data for the uses being supported and
shall ensure that the registrant is meeting the schedule for
the production of such data. If the Administrator deter-
mines that the registrant is not meeting or has not met
the schedule for the production of such data, the Adminis-
trator may proceed in accordance with clause (iv) of this
subparagraph regarding the continued registration of the
affected products with the minor and other uses and shall
inform the public of such action in accordance with section
6(f)(2). Notwithstanding the provisions of this clause, the
Administrator may deny, modify, or revoke the temporary
extension under this subparagraph if the Administrator
determines that the continuation of the minor use may
cause an unreasonable adverse effect on the environment.
In the event of modification or revocation, the Adminis-
trator shall provide, in writing, to the registrant a notice
revoking the temporary extension and establish a new ef-
fective date by which the minor use shall be deleted from
the registration.
(viii)(I) If data required to support registration of a
pesticide under subparagraph (A) is requested by a Fed-
eral or State regulatory authority, the Administrator shall,
to the extent practicable, coordinate data requirements,
test protocols, timetables, and standards of review and re-
duce burdens and redundancy caused to the registrant by
multiple requirements on the registrant.
(II) The Administrator may enter into a cooperative
agreement with a State to carry out subclause (I).
(Ill) Not later than 1 year after the date of enactment
of this clause, the Administrator shall develop a process to
identify and assist in alleviating future disparities between
Federal and State data requirements.
(C) SIMPLIFIED PROCEDURES.—Within nine months
after the date of enactment of this subparagraph, the Ad-
ministrator shall, by regulation, prescribe simplified proce-
dures 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 pur-
chased pesticide into the pesticide that is the subject of the
application shall be required to—
(i) submit or cite data pertaining to such pur-
chased product; or
(ii) offer to pay reasonable compensation otherwise
required by paragraph (1)(D) of this subsection for the
use of any such data.
(E) MINOR USE WAIVER.—In handling the registration
of a pesticide for a minor use, the Administrator may
waive otherwise applicable data requirements if the Ad-
ministrator determines that the absence of such data will
not prevent the Administrator from determining—
-------
25 _ FIFRA _ Sec. 3
(i) the incremental risk presented by the minor
use of the pesticide; and
(ii) that such risk, if any, would not be an unrea-
sonable adverse effect on the environment.
(3) TIME FOR ACTING WITH RESPECT TO APPLICATION. —
(A) IN GENERAL. — The Administrator shall review the
data after receipt of the application and shall, as expedi-
tiously as possible, either register the pesticide in accord-
ance with paragraph (5), or notify the applicant of the Ad-
ministrator's determination that it does not comply with
the provisions of the Act in accordance with paragraph (6).
(B) IDENTICAL OR SUBSTANTIALLY SIMILAR. — (i) The Ad-
ministrator shall, as expeditiously as possible, review and
act on any application received by the Administrator
(I) proposes the initial or amended registration of
an end-use pesticide that, if registered as proposed,
would be identical or substantially similar in composi-
tion and labeling to a currently-registered pesticide
identified in the application, or that would differ in
composition and labeling from such currently-reg-
istered pesticide only in ways that would not signifi-
cantly increase the risk of unreasonable adverse ef-
fects 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 incom-
plete, reject the application;
(II) within 90 days after receiving a complete ap-
plication, notify the registrant if the application has
been granted or denied; and
(III) if the application is denied, notify the reg-
istrant in writing of the specific reasons for the denial
of the application.
(C) MINOR USE REGISTRATION. —
(i) The Administrator shall, as expeditiously as
possible, review and act on any complete application —
(I) that proposes the initial registration of a
new pesticide active ingredient if the active ingre-
dient is proposed to be registered solely for minor
uses, or proposes a registration amendment solely
for minor uses to an existing registration; or
(II) for a registration or a registration amend-
ment that proposes significant minor uses.
(ii) For the purposes of clause (i) —
(I) the term "as expeditiously as possible"
means that the Administrator shall, to the great-
est extent practicable, complete a review and eval-
uation of all data, submitted with a complete ap-
-------
Sec. 3 _ FIFRA _ 26
plication, within 12 months after the submission
of the complete application, and the failure of the
Administrator to complete such a review and eval-
uation under clause (i) shall not be subject to judi-
cial review; and
(II) the term "significant minor uses" means 3
or more minor uses proposed for every nonminor
use, a minor use that would, in the judgment of
the Administrator, serve as a replacement for any
use which has been canceled in the 5 years pre-
ceding the receipt of the application, or a minor
use that in the opinion of the Administrator would
avoid the reissuance of an emergency exemption
under section 18 for that minor use.
(D) ADEQUATE TIME FOR SUBMISSION OF MINOR USE
DATA. — If a registrant makes a request for a minor use
waiver, regarding data required by the Administrator, pur-
suant to paragraph (2)(E), and if the Administrator denies
in whole or in part such data waiver request, the reg-
istrant shall have a full-time period for providing such
data. For purposes of this subparagraph, the term "full-
time period" means the time period originally established
by the Administrator for submission of such data, begin-
ning with the date of receipt by the registrant of the Ad-
ministrator's notice of denial.
(4) NOTICE OF APPLICATION. — The Administrator shall pub-
lish in the Federal Register, promptly after receipt of the state-
ment 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 the Administrator determines that, when
considered with any restrictions imposed under subsection
(A) its composition is such as to warrant the proposed
claims for it;
(B) its labeling and other material required to be sub-
mitted comply with the requirements of this Act;
(C) it will perform its intended function without un-
reasonable 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 Adminis-
trator 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
-------
27 FIFRA Sec. 3
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 deter-
mines that the requirements of paragraph (5) for registration
are not satisfied, the Administrator shall notify the applicant
for registration of the Administrator's determination and of the
Administrator's reasons (including the factual basis) therefor,
and that, unless the applicant corrects the conditions and noti-
fies the Administrator thereof during the 30-day period begin-
ning with the day after the date on which the applicant re-
ceives the notice, the Administrator may refuse to register the
pesticide. Whenever the Administrator refuses to register a
pesticide, the Administrator shall notify the applicant of the
Administrator's decision and of the Administrator's reasons (in-
cluding 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 notifica-
tion, the applicant for registration or other interested person
with the concurrence of the applicant shall have the same rem-
edies as provided for in section 6.
(7) REGISTRATION UNDER SPECIAL CIRCUMSTANCES.—Not-
withstanding 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 reg-
istered pesticide and use thereof, or differ only in ways
that would not significantly increase the risk of unreason-
able 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 reg-
istration 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 gen-
erated, the Administrator may register or amend the reg-
istration of the pesticide under such conditions as will re-
quire 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 pes-
ticide 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 signifi-
cantly increase the risk of any unreasonable adverse effect
-------
Sec. 3 FIFRA 28
on the environment. Notwithstanding the foregoing provi-
sions of this subparagraph, no registration of a pesticide
may be amended to permit an additional use of such pes-
ticide 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 di-
etary exposure enumerated in regulations issued under
this Act, and during the pendency of any risk-benefit eval-
uation 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 con-
currence of the Secretary of Agriculture, there is available
an effective alternative pesticide that does not meet or ex-
ceed such risk criteria. An applicant seeking amended reg-
istration 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 (other than data pertaining to the
proposed additional use) because it has not yet been gen-
erated, 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 suffi-
cient 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 subpara-
graph shall be granted only if the Administrator deter-
mines 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 ini-
tiate 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 vali-
dated test or other significant evidence raising prudent con-
cerns of unreasonable adverse risk to man or to the environ-
ment. 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.
(9) LABELING.—
-------
29 FIFRA Sec. 3
(A) ADDITIONAL STATEMENTS.—Subject to subpara-
graphs (B) and (C), it shall not be a violation of this Act
for a registrant to modify the labeling of an antimicrobial
pesticide product to include relevant information on prod-
uct efficacy, product composition, container composition or
design, or other characteristics that do not relate to any
pesticidal claim or pesticidal activity.
(B) REQUIREMENTS.—Proposed labeling information
under subparagraph (A) shall not be false or misleading,
shall not conflict with or detract from any statement re-
quired by law or the Administrator as a condition of reg-
istration, and shall be substantiated on the request of the
Administrator.
(C) NOTIFICATION AND DISAPPROVAL.—
(i) NOTIFICATION.—A registration may be modified
under subparagraph (A) if —
(I) the registrant notifies the Administrator in
writing not later than 60 days prior to distribution
or sale of a product bearing the modified labeling;
and
(II) the Administrator does not disapprove of
the modification under clause (ii).
(ii) DISAPPROVAL.—Not later than 30 days after
receipt of a notification under clause (i), the Adminis-
trator may disapprove the modification by sending the
registrant notification in writing stating that the pro-
posed language is not acceptable and stating the rea-
sons why the Administrator finds the proposed modi-
fication unacceptable.
(iii) RESTRICTION ON SALE.—A registrant may not
sell or distribute a product bearing a disapproved
modification.
(iv) OBJECTION.—A registrant may file an objec-
tion in writing to a disapproval under clause (ii) not
later than 30 days after receipt of notification of the
disapproval.
(v) FINAL ACTION.—A decision by the Adminis-
trator following receipt and consideration of an objec-
tion filed under clause (iv) shall be considered a final
agency action.
(D) USE DILUTION.—The label or labeling required
under this Act for an antimicrobial pesticide that is or may
be diluted for use may have a different statement of cau-
tion or protective measures for use of the recommended di-
luted solution of the pesticide than for use of a concentrate
of the pesticide if the Administrator determines that —
(i) adequate data have been submitted to support
the statement proposed for the diluted solution uses;
and
(ii) the label or labeling provides adequate protec-
tion for exposure to the diluted solution of the pes-
ticide.
(10) EXPEDITED REGISTRATION OF PESTICIDES.—
-------
Sec. 3 FIFRA 30
(A) Not later than 1 year after the date of enactment
of this paragraph, the Administrator shall, utilizing public
comment, develop procedures and guidelines, and expedite
the review of an application for registration of a pesticide
or an amendment to a registration that satisfies such
guidelines.
(B) Any application for registration or an amendment,
including biological and conventional pesticides, will be
considered for expedited review under this paragraph. An
application for registration or an amendment shall qualify
for expedited review if use of the pesticide proposed by the
application may reasonably be expected to accomplish 1 or
more of the following:
(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of pesticides to nontarget or-
ganisms.
(iii) Reduce the potential for contamination of
groundwater, surface water, or other valued environ-
mental resources.
(iv) Broaden the adoption of integrated pest man-
agement strategies, or make such strategies more
available or more effective.
(C) The Administrator, not later than 30 days after re-
ceipt of an application for expedited review, shall notify
the applicant whether the application is complete. If it is
found to be incomplete, the Administrator may either re-
ject the request for expedited review or ask the applicant
for additional information to satisfy the guidelines devel-
oped under subparagraph (A).
(d) CLASSIFICATION OF PESTICIDES.—
(1) CLASSIFICATION FOR GENERAL USE, RESTRICTED USE, OR
BOTH.—
(A) As a part of the registration of a pesticide the Ad-
ministrator 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 reg-
istered should be for restricted use, the Administrator
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 Admin-
istrator may require that its packaging and labeling for re-
stricted uses shall be clearly distinguishable from its pack-
aging 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 reg-
istered, or for one or more of such uses, or in accordance
with a widespread and commonly recognized practice, will
-------
31 FIFRA Sec. 3
not generally cause unreasonable adverse effects on the
environment, the Administrator 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 reg-
istered, 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, includ-
ing injury to the applicator, the Administrator shall clas-
sify 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
inhalation 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 classi-
fication 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 addi-
tional regulatory restriction may cause unreasonable
adverse effects on the environment, the pesticide shall
be applied for any use to which the determination ap-
plies only by or under the direct supervision of a cer-
tified 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 af-
fected filed within 60 days of the publication of the
regulation in final form.
(2) CHANGE IN CLASSIFICATION.—If the Administrator de-
termines that a change in the classification of any use of a pes-
ticide from general use to restricted use is necessary to prevent
unreasonable adverse effects on the environment, the Adminis-
trator shall notify the registrant of such pesticide of such de-
termination 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 Admin-
istrator to change any such classification from restricted to
general use. Such petition shall set out the basis for the reg-
istrant's position that restricted use classification is unneces-
sary because classification of the pesticide for general use
would not cause unreasonable adverse effects on the environ-
ment. The Administrator, within sixty days after receiving
-------
Sec. 3 FIFRA 32
such petition, shall notify the registrant whether the petition
has been granted or denied. Any denial shall contain an expla-
nation therefor and any such denial shall be subject to judicial
review under section 16 of this Act.
(e) PRODUCTS WITH SAME FORMULATION AND CLAIMS.—Prod-
ucts 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 ad-
ditional names and labels shall be added to the registration by sup-
plemental statements.
(f) MISCELLANEOUS.—
(1) EFFECT OF CHANGE OF LABELING OR FORMULATION.—If
the labeling or formulation for a pesticide is changed, the reg-
istration shall be amended to reflect such change if the Admin-
istrator determines that the change will not violate any provi-
sion of this Act.
(2) REGISTRATION NOT A DEFENSE.—In no event shall reg-
istration of an article be construed as a defense for the com-
mission of any offense under this Act. As long as no cancella-
tion 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 con-
sult with any other Federal agency.
(4) MIXTURES OF NITROGEN STABILIZERS AND FERTILIZER
PRODUCTS.—Any mixture or other combination of—
(A) 1 or more nitrogen stabilizers registered under this
Act; and
(B) 1 or more fertilizer products,
shall not be subject to the provisions of this section or sections
4, 5, 7, 15, and 17(a)(2) if the mixture or other combination is
accompanied by the labeling required under this Act for the ni-
trogen stabilizer contained in the mixture or other combina-
tion, the mixture or combination is mixed or combined in ac-
cordance with such labeling, and the mixture or combination
does not contain any active ingredient other than the nitrogen
stabilizer.
(g) REGISTRATION REVIEW.—
(1)(A) GENERAL RULE.—The registrations of pesticides are
to be periodically reviewed. The Administrator shall by regula-
tion establish a procedure for accomplishing the periodic re-
view of registrations. The goal of these regulations shall be a
review of a pesticide's registration every 15 years. No registra-
tion shall be canceled as a result of the registration review
process unless the Administrator follows the procedures and
substantive requirements of section 6.
(B) LIMITATION.—Nothing in this subsection shall prohibit
the Administrator from undertaking any other review of a pes-
ticide pursuant to this Act.
-------
33 FIFRA Sec. 3
(2)(A) DATA.—The Administrator shall use the authority in
subsection (c)(2)(B) to require the submission of data when
such data are necessary for a registration review.
(B) DATA SUBMISSION, COMPENSATION, AND EXEMPTION.—
For purposes of this subsection, the provisions of subsections
(c)(l), (c)(2)(B), and (c)(2)(D) shall be utilized for and be appli-
cable to any data required for registration review.
(h) REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PES-
TICIDES.—
(1) EVALUATION OF PROCESS.—To the maximum extent
practicable consistent with the degrees of risk presented by an
antimicrobial pesticide and the type of review appropriate to
evaluate the risks, the Administrator shall identify and evalu-
ate reforms to the antimicrobial registration process that
would reduce review periods existing as of the date of enact-
ment of this subsection for antimicrobial pesticide product reg-
istration applications and applications for amended registra-
tion of antimicrobial pesticide products, including—
(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial pes-
ticides; and
(D) amendments to antimicrobial pesticide registra-
tions.
(2) REVIEW TIME PERIOD REDUCTION GOAL.—Each reform
identified under paragraph (1) shall be designed to achieve the
goal of reducing the review period following submission of a
complete application, consistent with the degree of risk, to a
period of not more than—
(A) 540 days for a new antimicrobial active ingredient
pesticide registration;
(B) 270 days for a new antimicrobial use of a reg-
istered active ingredient;
(C) 120 days for any other new antimicrobial product;
(D) 90 days for a substantially similar or identical
antimicrobial product;
(E) 90 days for an amendment to an antimicrobial reg-
istration that does not require scientific review of data;
and
(F) 90 to 180 days for an amendment to an
antimicrobial registration that requires scientific review of
data and that is not otherwise described in this paragraph.
(3) IMPLEMENTATION.—
(A) PROPOSED RULEMAKING.—
(i) ISSUANCE.—Not later than 270 days after the
date of enactment of this subsection, the Adminis-
trator shall publish in the Federal Register proposed
regulations to accelerate and improve the review of
antimicrobial pesticide products designed to imple-
ment, to the extent practicable, the goals set forth in
paragraph (2).
(ii) REQUIREMENTS.—Proposed regulations issued
under clause (i) shall—
-------
Sec. 3 FIFRA 34
(I) define the various classes of antimicrobial
use patterns, including household, industrial, and
institutional disinfectants and sanitizing pes-
ticides, preservatives, water treatment, and pulp
and paper mill additives, and other such products
intended to disinfect, sanitize, reduce, or mitigate
growth or development of microbiological orga-
nisms, or protect inanimate objects, industrial
processes or systems, surfaces, water, or other
chemical substances from contamination, fouling,
or deterioration caused by bacteria, viruses, fungi,
protozoa, algae, or slime;
(II) differentiate the types of review under-
taken for antimicrobial pesticides;
(III) conform the degree and type of review to
the risks and benefits presented by antimicrobial
pesticides and the function of review under this
Act, considering the use patterns of the product,
toxicity, expected exposure, and product type;
(IV) ensure that the registration process is
sufficient to maintain antimicrobial pesticide effi-
cacy and that antimicrobial pesticide products
continue to meet product performance standards
and effectiveness levels for each type of label
claim made; and
(V) implement effective and reliable deadlines
for process management.
(iii) COMMENTS.—In developing the proposed regu-
lations, the Administrator shall solicit the views from
registrants and other affected parties to maximize the
effectiveness of the rule development process.
(B) FINAL REGULATIONS.—
(i) ISSUANCE.—The Administrator shall issue final
regulations not later than 240 days after the close of
the comment period for the proposed regulations.
(ii) FAILURE TO MEET GOAL.—If a goal described in
paragraph (2) is not met by the final regulations, the
Administrator shall identify the goal, explain why the
goal was not attained, describe the element of the reg-
ulations included instead, and identify future steps to
attain the goal.
(iii) REQUIREMENTS.—In issuing final regulations,
the Administrator shall—
(I) consider the establishment of a certifi-
cation process for regulatory actions involving
risks that can be responsibly managed, consistent
with the degree of risk, in the most cost-efficient
manner;
(II) consider the establishment of a certifi-
cation process by approved laboratories as an ad-
junct to the review process;
(III) use all appropriate and cost-effective re-
view mechanisms, including—
-------
35 FIFRA Sec. 3
(aa) expanded use of notification and non-
notification procedures;
(bb) revised procedures for application re-
view; and
(cc) allocation of appropriate resources to
ensure streamlined management of
antimicrobial pesticide registrations; and
(IV) clarify criteria for determination of the
completeness of an application.
(C) EXPEDITED REVIEW.—This subsection does not af-
fect the requirements or extend the deadlines or review pe-
riods contained in subsection (c)(3).
(D) ALTERNATIVE REVIEW PERIODS.—If the final regula-
tions to carry out this paragraph are not effective 630 days
after the date of enactment of this subsection, until the
final regulations become effective, the review period, be-
ginning on the date of receipt by the Agency of a complete
application, shall be—
(i) 2 years for a new antimicrobial active ingredi-
ent pesticide registration;
(ii) 1 year for a new antimicrobial use of a reg-
istered active ingredient;
(iii) 180 days for any other new antimicrobial
product;
(iv) 90 days for a substantially similar or identical
antimicrobial product;
(v) 90 days for an amendment to an antimicrobial
registration that does not require scientific review of
data; and
(vi) 240 days for an amendment to an
antimicrobial registration that requires scientific re-
view of data and that is not otherwise described in
this subparagraph.
(E) WOOD PRESERVATIVES.—An application for the reg-
istration, or for an amendment to the registration, of a
wood preservative product for which a claim of pesticidal
activity listed in section 2(mm) is made (regardless of any
other pesticidal claim that is made with respect to the
product) shall be reviewed by the Administrator within the
same period as that established under this paragraph for
an antimicrobial pesticide product application, consistent
with the degree of risk posed by the use of the wood pre-
servative product, if the application requires the applicant
to satisfy the same data requirements as are required to
support an application for a wood preservative product
that is an antimicrobial pesticide.
(F) NOTIFICATION.—
(i) IN GENERAL.—Subject to clause (iii), the Admin-
istrator shall notify an applicant whether an applica-
tion has been granted or denied not later than the
final day of the appropriate review period under this
paragraph, unless the applicant and the Administrator
agree to a later date.
-------
Sec. 4 FIFRA 36
(ii) FINAL DECISION.—If the Administrator fails to
notify an applicant within the period of time required
under clause (i), the failure shall be considered an
agency action unlawfully withheld or unreasonably de-
layed for purposes of judicial review under chapter 7
of title 5, United States Code.
(iii) EXEMPTION.—This subparagraph does not
apply to an application for an antimicrobial pesticide
that is filed under subsection (c)(3)(B) prior to 90 days
after the date of enactment of this subsection.
(4) ANNUAL REPORT.—
(A) SUBMISSION.—Beginning on the date of enactment
of this subsection and ending on the date that the goals
under paragraph (2) are achieved, the Administrator shall,
not later than March 1 of each year, prepare and submit
an annual report to the Committee on Agriculture of the
House of Representatives and the Committee on Agri-
culture, Nutrition, and Forestry of the Senate.
(B) REQUIREMENTS.—A report submitted under sub-
paragraph (A) shall include a description of—
(i) measures taken to reduce the backlog of pend-
ing registration applications;
(ii) progress toward achieving reforms under this
subsection; and
(iii) recommendations to improve the activities of
the Agency pertaining to antimicrobial registrations.
SEC. 4. [136a-l] REREGISTRATION OF REGISTERED PESTICIDES.
(a) GENERAL RULE.—The Administrator shall reregister, in ac-
cordance 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 Admin-
istrator has determined, after November 1, 1984, and before the ef-
fective date of this section, 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 sub-
section (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 re-
specting 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 in-
adequate data within the applicable time period.
(3) The third phase shall include submission to the Admin-
istrator by registrants of the information required under sub-
section (e).
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) of submis-
sions under phases two and three, identification of outstanding
-------
37 FIFRA Sec. 4
data requirements, and the issuance, as necessary, of requests
for additional data.
(5) The fifth phase shall include the review by the Admin-
istrator under subsection (g) of data submitted for reregistra-
tion and appropriate regulatory action by the Administrator.
(c) PHASE ONE.—
(1) PRIORITY FOR REREGISTRATION.—For purposes of the re-
registration 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) 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 to have significant out-
standing 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, list pesticide active ingredients for which reg-
istration 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 deter-
mined under paragraph (1);
(C) not later than 7 months after such effective date,
list the second 150 pesticide active ingredients, as deter-
mined 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 Admin-
istrator 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-
CD IN GENERAL.—The registrant of a pesticide that con-
tains 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).
-------
Sec. 4 FIFRA 38
(2) NOTICE OF INTENT TO SEEK OR NOT TO SEEK REREG-
ISTRATION.—
(A) The registrant of a pesticide containing an active
ingredient listed under subparagraph (B), (C), or (D) of
subsection (c)(2) shall notify the Administrator by certified
mail whether the registrant intends to seek or does not in-
tend to seek reregistration of the pesticide.
(B) If a registrant submits a notice under subpara-
graph (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 sub-
mitted.
(3) MISSING OR INADEQUATE DATA.—Each registrant of a
pesticide that contains an active ingredient listed under sub-
paragraph (B), (C), or (D) of subsection (cK2) and for which the
registrant submitted a notice under paragraph (2) of an inten-
tion to seek reregistration of such pesticide shall submit to the
Administrator—
(A) in accordance with regulations issued by the Ad-
ministrator under section 3, an identification of—
(i) all data that are required by regulation to sup-
port 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 pes-
ticide 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 identi-
fied 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 subpara-
graph (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)(l)(G) that the reg-
istrant possesses or has access to the raw data used in or gen-
erated by such study. For purposes of a submission by a reg-
istrant 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 satis-
faction of the Administrator that such data should be consid-
ered 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—
-------
39 FIFRA Sec. 4
(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 list-
ing 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 list-
ing 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 list-
ing of such active ingredient.
On application, the Administrator may extend a time pe-
riod prescribed by this subparagraph if the Administrator
determines that factors beyond the control of the reg-
istrant 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 Adminis-
trator, 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 pre-
scribed 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. Upon application of a reg-
istrant, the Administrator shall, in the case of a minor use,
extend the deadline for the production of residue chemistry
data under this subparagraph for data required solely to
support that minor use until the final deadline for submis-
sion of data under this section for the other uses of the
pesticide established as of the date of enactment of the
Food Quality Protection Act of 1996 if—
(i) the data to support other uses of the pesticide
on a food are being provided;
(ii) the registrant, in submitting a request for such
an extension provides a schedule, including interim
dates to measure progress, to assure that the data pro-
duction will be completed before the expiration of the
extension period;
(iii) the Administrator has determined that such
extension will not significantly delay the Administra-
tor's schedule for issuing a reregistration eligibility de-
termination required under this section; and
(iv) the Administrator has determined that based
on existing data, such extension would not signifi-
cantly increase the risk of any unreasonable adverse
effect on the environment.1 If the Administrator
grants an extension under this subparagraph, the Ad-
ministrator shall monitor the development of the data
1 Indentation of the following sentences of this subparagraph is so in original (as added by
sec. 201(cX2) of P.L. 104-170). Probably should be indented the same as flush matter of this
subparagraph.
-------
Sec. 4 FIFRA 40
and shall ensure that the registrant is meeting the
schedule for the production of the data. If the Admin-
istrator determines that the registrant is not meeting
or has not met the schedule for the production of such
data, the Administrator may proceed in accordance
with clause (iv) of section 3(c)(2)(B) or other provisions
of this section, as appropriate, regarding the continued
registration of the affected products with the minor
use and shall inform the public of such action. Not-
withstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the
extension under this subparagraph if the Adminis-
trator determines that the extension for the minor use
may cause an unreasonable adverse effect on the envi-
ronment. In such circumstance, the Administrator
shall provide written notice to the registrant revoking
the extension of time for submission of data. Such
data shall instead be due in accordance with the date
then established by the Administrator for submission
of the data.
(5) CANCELLATION AND REMOVAL.—
(A) If the registrant of a pesticide does not submit a
notice under paragraph (2) or (3) within the time pre-
scribed by paragraph (4)(A), the Administrator shall issue
a notice of intent to cancel the registration of such reg-
istrant 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 per-
son.
(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 contain-
ing that active ingredient;
(II) no such registrant complies with paragraph
(3)(A); or
(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 in-
tent to cancel the registrations of all pesticides containing
such active ingredient and shall provide 60 days for com-
ment on such notice.
(ii) After the 60-day period has expired, the Adminis-
trator, by order, may cancel any such registration without
hearing, except that the Administrator shall not cancel a
registration under this subparagraph if—
-------
41 FIFRA Sec. 4
(I) during the comment period a person acquires
the rights of the registrant in that registration;
(II) during the comment period that person fur-
nishes 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)(l) has been paid.
(6) SUSPENSIONS AND PENALTIES.—The Administrator shall
issue a notice of intent to suspend the registration of a pes-
ticide in accordance with the procedures prescribed by section
3(cX2)(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 Adminis-
trator within such time period. If the registrant does not com-
mit to support a specific minor use of the pesticide, but is sup-
porting and providing data in a timely and adequate fashion
to support uses of the pesticide on a food, or if all uses of the
pesticide are nonfood uses and the registrant does not commit
to support a specific minor use of the pesticide but is support-
ing and providing data in a timely and adequate fashion to
support other nonfood uses of the pesticide, the Administrator,
at the written request of the registrant, shall not take any ac-
tion pursuant to this paragraph in regard to such unsupported
minor use until the final deadline established as of the date of
enactment of the Food Quality Protection Act of 1996, for the
submission of data under this section for the supported uses
identified pursuant to this paragraph unless the Administrator
determines that the absence of the data is significant enough
to cause human health or environmental concerns. On such a
determination the Administrator may refuse the request for ex-
tension by the registrant. Upon receipt of the request from the
registrant, the Administrator shall publish in the Federal Reg-
ister a notice of the receipt of the request and the effective date
upon which the uses not being supported will be voluntarily
deleted from the registration pursuant to section 6(f)(l). If the
Administrator grants an extension under this paragraph, the
Administrator shall monitor the development of the data for
the uses being supported and shall ensure that the registrant
is meeting the schedule for the production of such data. If the
Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data, the
Administrator may proceed in accordance with section
3(c)(2)(B)(iv) regarding the continued registration of the af-
fected products with the minor and other uses and shall inform
the public of such action in accordance with section 6(f)(2). Not-
withstanding this subparagraph, the Administrator may deny,
modify, or revoke the temporary extension under this para-
graph if the Administrator determines that the continuation of
the minor use may cause an unreasonable adverse effect on the
environment. In the event of modification or revocation, the
-------
Sec. 4 FIFRA 42
Administrator shall provide, in writing, to the registrant a no-
tice revoking the temporary extension and establish a new ef-
fective date by which the minor use shall be deleted from the
registration.
(e) PHASE THREE.—
(1) INFORMATION ABOUT STUDIES.—Each registrant of a
pesticide that contains an active ingredient listed under sub-
paragraph (B), (C), or (D) of subsection (c)(2) who has submit-
ted a notice under subsection (d)(2) of an intent to seek the re-
registration 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 in-
gredient previously submitted by the registrant in support
of the registration of a pesticide containing such active in-
gredient 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 in-
gredient previously submitted by the registrant in support
of the registration of a pesticide containing such active in-
gredient 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 summa-
rized under subparagraph (A) or (B) by the registrant con-
cerning 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 be-
fore 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) indi-
cating 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 Adminis-
trator 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 out-
standing data requirement identified by the reg-
istrant; or
(ii) an offer to share in the cost of developing such
data to be incurred by a person who has made a com-
mitment under clause (i) to submit such data, and an
-------
43 FIFRA Sec. 4
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)(l)(D)(ii)
and regulations issued thereunder with regard to pre-
viously submitted data as if the registrant were now seek-
ing 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 Adminis-
trator, but not more than 48 months after the date the
registrant submitted the commitment under such para-
graph. The Administrator, on application of a registrant,
may extend the period prescribed by the preceding sen-
tence by no more than 2 years if extraordinary cir-
cumstances beyond the control of the registrant prevent
the registrant from submitting data within such prescribed
period. Upon application of a registrant, the Administrator
shall, in the case of a minor use, extend the deadline for
the production of residue chemistry data under this sub-
paragraph for data required solely to support that minor
use until the final deadline for submission of data under
this section for the other uses of the pesticide established
as of the date of enactment of the Food Quality Protection
Act of 1996 if—
(i) the data to support other uses of the pesticide
on a food are being provided;
(ii) the registrant, in submitting a request for such
an extension provides a schedule, including interim
dates to measure progress, to assure that the data pro-
duction will be completed before the expiration of the
extension period;
(iii) the Administrator has determined that such
extension will not significantly delay the Administra-
tor's schedule for issuing a reregistration eligibility de-
termination required under this section; and
-------
Sec. 4 FIFRA 44
(iv) the Administrator has determined that based
on existing data, such extension would not signifi-
cantly increase the risk of any unreasonable adverse
effect on the environment.1 If the Administrator
grants an extension under this subparagraph, the Ad-
ministrator shall monitor the development of the data
and shall ensure that the registrant is meeting the
schedule for the production of the data. If the Admin-
istrator determines that the registrant is not meeting
or has not met the schedule for the production of such
data, the Administrator may proceed in accordance
with clause (iv) of section 3(c)(2)(B) or other provisions
of this section, as appropriate, regarding the continued
registration of the affected products with the minor
use and shall inform the public of such action. Not-
withstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the
extension under this subparagraph if the Adminis-
trator determines that the extension for the minor use
may cause an unreasonable adverse effect on the envi-
ronment. In such circumstance, the Administrator
shall provide written notice to the registrant revoking
the extension of time for submission of data. Such
data shall instead be due in accordance with the date
then established by the Administrator for submission
of the data.
(3) CANCELLATION.—
(A) If the registrant of a pesticide fails to submit the
information required by paragraph (1) within the time pre-
scribed by paragraph (2), the Administrator, by order and
without hearing, shall cancel the registration of such pes-
ticide. If the registrant does not commit to support a spe-
cific minor use of the pesticide, but is supporting and pro-
viding data in a timely and adequate fashion to support
uses of the pesticide on a food, or if all uses of the pes-
ticide are nonfood uses and the registrant does not commit
to support a specific minor use of the pesticide but is sup-
porting and providing data in a timely and adequate fash-
ion to support other nonfood uses of the pesticide, the Ad-
ministrator, at the written request of the registrant, shall
not take any action pursuant to this subparagraph in re-
gard to such unsupported minor use until the final dead-
line established as of the date of enactment of the Food
Quality Protection Act of 1996, for the submission of data
under this section for the supported uses identified pursu-
ant to this subparagraph unless the Administrator deter-
mines that the absence of the data is significant enough to
cause human health or environmental concerns. On the
basis of such determination, the Administrator may refuse
the request for extension by the registrant. Upon receipt
of the request from the registrant, the Administrator shall
'Indentation of the following sentences of this subparagraph is so in original (as added by
sec. 201(cX2) of P.L. 104-170). Probably should be indented the same as flush matter of this
subparagraph.
-------
45 FIFRA Sec. 4
publish in the Federal Register a notice of the receipt of
the request and the effective date upon which the uses not
being supported will be voluntarily deleted from the reg-
istration pursuant to section 6(f)(l). If the Administrator
grants an extension under this subparagraph, the Admin-
istrator shall monitor the development of the data for the
uses being supported and shall ensure that the registrant
is meeting the schedule for the production of such data. If
the Administrator determines that the registrant is not
meeting or has not met the schedule for the production of
such data, the Administrator may proceed in accordance
with section 3(c)(2)(B)(iv) regarding the continued registra-
tion of the affected products with the minor and other uses
and shall inform the public of such action in accordance
with section 6(f)(2). Notwithstanding this subparagraph,
the Administrator may deny, modify, or revoke the tem-
porary extension under this subparagraph if the Adminis-
trator determines that the continuation of the minor use
may cause an unreasonable adverse effect on the environ-
ment. In the event of modification or revocation, the Ad-
ministrator shall provide, in writing, to the registrant a
notice revoking the temporary extension and establish a
new effective date by which the minor use shall be deleted
from the registration.
(B)(i) If the registrant of a pesticide submits the infor-
mation required by paragraph (1) within the time pre-
scribed 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 con-
form 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 reg-
istrant a reasonable period of time to make any necessary
changes or corrections.
(iii)(I) If the Administrator determines that the reg-
istrant 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 hear-
ing or further notice at the end of 30 days after receipt by
the registrant of the notice unless during that time a re-
quest for a hearing is made by the registrant.
(Ill) If a hearing is requested, a hearing shall be con-
ducted 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 deter-
mination made within 75 days after receipt of a request for
hearing.
(4) GUIDELINES.—
-------
Sec. 4 FIFRA 46
(A) Not later than 1 year after the effective date of
this section, the Administrator, by order, shall issue guide-
lines 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 sec-
tion 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 OUT-
STANDING 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)(l) to determine
if such submissions identified all the data that are missing
or inadequate for such active ingredient. To assist the re-
view of the Administrator under this subparagraph, the
Administrator may require a registrant seeking reregistra-
tion to submit complete copies of studies summarized
under subsection (e)(l).
(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 re-
quirements.
(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 ac-
tive 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 ac-
tive 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 ac-
tive 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 rea-
-------
47 FIFRA Sec. 4
sonable period of time, as determined by the Adminis-
trator, but not to exceed 48 months after the issuance of
such notice. The Administrator, on application of a reg-
istrant, may extend the period prescribed by the preceding
sentence by no more than 2 years if extraordinary cir-
cumstances beyond the control of the registrant prevent
the registrant from submitting data within such prescribed
period. Upon application of a registrant, the Administrator
shall, in the case of a minor use, extend the deadline for
the production of residue chemistry data under this sub-
paragraph for data required solely to support that minor
use until the final deadline for submission of data under
this section for the other uses of the pesticide established
as of the date of enactment of the Food Quality Protection
Act of 1996 if—
(i) the data to support other uses of the pesticide
on a food are being provided;
(ii) the registrant, in submitting a request for such
an extension provides a schedule, including interim
dates to measure progress, to assure that the data pro-
duction will be completed before the expiration of the
extension period;
(iii) the Administrator has determined that such
extension will not significantly delay the Administra-
tor's schedule for issuing a reregistration eligibility de-
termination required under this section; and
(iv) the Administrator has determined that based
on existing data, such extension would not signifi-
cantly increase the risk of any unreasonable adverse
effect on the environment.1 If the Administrator
grants an extension under this subparagraph, the Ad-
ministrator shall monitor the development of the data
and shall ensure that the registrant is meeting the
schedule for the production of the data. If the Admin-
istrator determines that the registrant is not meeting
or has not met the schedule for the production of such
data, the Administrator may proceed in accordance
with clause (iv) of section 3(c)(2)(B) or other provisions
of this section, as appropriate, regarding the continued
registration of the affected products with the minor
use and shall inform the public of such action. Not-
withstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the
extension under this subparagraph if the Adminis-
trator determines that the extension for the minor use
may cause an unreasonable adverse effect on the envi-
ronment. In such circumstance, the Administrator
shall provide written notice to the registrant revoking
the extension of time for submission of data. Such
data shall instead be due in accordance with the date
1 Indentation of the following sentences of this subparagraph is so in original (as added by
sec. 201(cX2) of P.L. 104-170). Probably should be indented the same as flush matter of this
subparagraph.
-------
Sec. 4 FIFRA 48
then established by the Administrator for submission
of the data.
(3) SUSPENSIONS AND PENALTIES.—The Administrator shall
issue a notice of intent to suspend the registration of a pes-
ticide in accordance with the procedures prescribed by section
3(c)(2)(B)(iv) if the Administrator determines that (A) tests nec-
essary to fill an outstanding data requirement for such pes-
ticide have not been initiated within 1 year after the issuance
of a notice under paragraph (1)(B), or (B) progress is insuffi-
cient 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. If the registrant does not commit to
support a specific minor use of the pesticide, but is supporting
and providing data in a timely and adequate fashion to support
uses of the pesticide on a food, or if all uses of the pesticide
are nonfood uses and the registrant does not commit to support
a specific minor use of the pesticide but is supporting and pro-
viding data in a timely and adequate fashion to support other
nonfood uses of the pesticide, the Administrator, at the written
request of the registrant, shall not take any action pursuant to
this paragraph in regard to such unsupported minor use until
the final deadline established as of the date of enactment of
the Food Quality Protection Act of 1996, for the submission of
data under this section for the supported uses identified pursu-
ant to this paragraph unless the Administrator determines
that the absence of the data is significant enough to cause
human health or environmental concerns. On such a deter-
mination the Administrator may refuse the request for exten-
sion by the registrant. Upon receipt of the request from the
registrant, the Administrator shall publish in the Federal Reg-
ister a notice of the receipt of the request and the effective date
upon which the uses not being supported will be voluntarily
deleted from the registration pursuant to section 6(f)(l). If the
Administrator grants an extension under this paragraph, the
Administrator shall monitor the development of the data for
the uses being supported and shall ensure that the registrant
is meeting the schedule for the production of such data. If the
Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data, the
Administrator may proceed in accordance with section
3(c)(2)(B)(iv) regarding the continued registration of the af-
fected products with the minor and other uses and shall inform
the public of such action in accordance with section 6(f)(2). Not-
withstanding this subparagraph, the Administrator may deny,
modify, or revoke the temporary extension under this para-
graph if the Administrator determines that the continuation of
the minor use may cause an unreasonable adverse effect on the
environment. In the event of modification or revocation, the
Administrator shall provide, in writing, to the registrant a no-
tice revoking the temporary extension and establish a new ef-
fective date by which the minor use shall be deleted from the
registration.
(g) PHASE FIVE.—
-------
49 FIFRA Sec. 4
(1) DATA REVIEW.—The Administrator shall conduct a thor-
ough examination of all data submitted under this section con-
cerning an active ingredient listed under subsection (c)(2) and
of all other available data found by the Administrator to be rel-
evant.
(2) REREGISTRATION AND OTHER ACTIONS.—
(A) Within 1 year after the submission of all data con-
cerning an active ingredient of a pesticide under sub-
section (f), the Administrator shall determine whether pes-
ticides containing such active ingredient are eligible for re-
registration. For extraordinary circumstances, the Admin-
istrator may extend such period for not more than 1 addi-
tional 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 Admin-
istrator 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 review
required by subparagraph (B) of this paragraph, the Ad-
ministrator shall determine whether to reregister a pes-
ticide by determining whether such pesticide meets the re-
quirements of section 3(c)(5). If the Administrator deter-
mines that a pesticide is eligible to be reregistered, the Ad-
ministrator 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.
(E) As soon as the Administrator has sufficient infor-
mation with respect to the dietary risk of a particular ac-
tive ingredient, but in any event no later than the time the
Administrator makes a determination under subparagraph
(C) or (D) with respect to pesticides containing a particular
active ingredient, the Administrator shall—
(i) reassess each associated tolerance and exemp-
tion from the requirement for a tolerance issued under
section 408 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 346a);
(ii) determine whether such tolerance or exemp-
tion meets the requirements of that Act;
(iii) determine whether additional tolerances or
exemptions should be issued;
(iv) publish in the Federal Register a notice set-
ting forth the determinations made under this sub-
paragraph; and
-------
Sec. 4 FIFRA 50
(v) commence promptly such proceedings under
this Act and section 408 of the Federal Food, Drug,
and Cosmetic Act as are warranted by such deter-
minations.
(h) COMPENSATION OF DATA SUBMITTER.—If data that are sub-
mitted 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 compensa-
tion for the use of such data as prescribed by section 3(c)(l)(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 ac-
tive 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 collec-
tively 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 ingredi-
ent under subsection (e)(l) 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)(l)(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 pre-
scribe.
(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 cor-
responding 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 reg-
istered for a major food or feed use shall collectively pay
-------
51 FIFRA Sec. 4
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) An active ingredient that is contained only in pes-
ticides that are registered solely for agricultural or non-
agricultural minor uses, or a pesticide the value or volume
of use of which is small, shall be exempt from the fees pre-
scribed by paragraph (3).
(B) The Administrator shall exempt any public health
pesticide from the payment of the fee prescribed under
paragraph (3) if, in consultation with the Secretary of
Health and Human Services, the Administrator deter-
mines, based on information supplied by the registrant,
that the economic return to the registrant from sales of the
pesticide does not support the registration or reregistration
of the pesticide.
(C) 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 con-
tained only in pesticides that are not registered for any
food or feed use and that are—
(i) sanitizers intended to reduce the number of liv-
ing bacteria or viable virus particles on inanimate sur-
face 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 irrevers-
ibly inactivate bacteria, fungi, or viruses on surfaces
or inanimate objects;
(iv) sterilizers intended to destroy viruses and all
living bacteria, fungi, and their spores on inanimate
surfaces; or
(v) fungicides or fungistats.
(D)(i) Notwithstanding any other provision of this sub-
section, in the case of a small business registrant of a pes-
ticide, the registrant shall pay a fee for the reregistration
of each active ingredient of the pesticide that does not ex-
ceed an amount determined in accordance with this sub-
paragraph.
(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.
-------
Sec. 4 FIFRA 52
(iii) For the purpose of this subparagraph, a small
business registrant is a corporation, partnership, or unin-
corporated business that—
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to reregistra-
tion, 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 Janu-
ary 15 of each year of—
(i) $650 for the first registration; and
(ii) $1,300 for each additional registration, except
that no fee shall be charged for more than 200 reg-
istrations held by any registrant.
(B) In the case of a pesticide that is registered for a
minor agricultural use, the Administrator may reduce or
waive the payment of the fee imposed under this para-
graph if the Administrator determines that the fee would
significantly reduce the availability of the pesticide for the
use.
(C)(i)1 The amount of each fee prescribed under sub-
paragraph (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.
(ii)1 in2 each of the fiscal years 1998, 1999, and 2000,
the Administrator is authorized to collect up to an addi-
tional $2,000,000 in a manner consistent with subsection
(k)(5) and the recommendations of the Inspector General of
the Environmental Protection Agency. The total fees that
may be collected under this clause shall not exceed
$6,000,000.
(D) The maximum annual fee payable under this para-
graph by—
(i) a registrant holding not more than 50 pesticide
registrations shall be $55,000; and
(ii) a registrant holding over 50 registrations shall
be $95,000.
(E)(i) For a small business, the maximum annual fee
payable under this paragraph by—
(I) a registrant holding not more than 50 pesticide
registrations shall be $38,500; and
(II) a registrant holding over 50 pesticide registra-
tions shall be $66,500.
(ii) For purposes of clause (i), the term "small busi-
ness" means a corporation, partnership, or unincorporated
business that—
(I) has 150 or fewer employees; and
1Sec. 501(aX2) of P.L. 104-170 amended para. (5XC) of sec. 4(i) (7 U.S.C. 136a-l(i)) by insert-
ing "(i)" after "(CT and adding clause (ii), without specifying the Act that was being amended.
The amendments were executed to this Act to effectuate the probable intent of Congress.
2 So in original (as added by sec. 501(aX2) of P.L. 104-170). Probably should be "In".
-------
53 FIFRA Sec. 4
(II) during the 3-year period prior to the most re-
cent maintenance fee billing cycle, had an average an-
nual gross revenue from chemicals that did not exceed
$40,000,000.
(F) The Administrator shall exempt any public health
pesticide from the payment of the fee prescribed under
paragraph (3) if, in consultation with the Secretary of
Health and Humans1 Services, the Administrator deter-
mines, based on information supplied by the registrant,
that the economic return to the registrant from sales of the
pesticide does not support the registration or reregistration
of the pesticide.
(G) If any fee prescribed by this paragraph with re-
spect to the registration of a pesticide is not paid by a reg-
istrant by the time prescribed, the Administrator, by order
and without hearing, may cancel the registration.
(H) The authority provided under this paragraph shall
terminate on September 30, 2001.2
(6) OTHER FEES.—During the period beginning on the date
of enactment of this section and ending on September 30,
2001,* 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 in-
gredient 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 ac-
tive ingredient shall pay fees in accordance with para-
graph (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 contain-
ing such active ingredient collectively pay more than
25 percent of the total active ingredient reregistration
fee.
(B) The Administrator, by order, may require any reg-
istrant to submit such reports as the Administrator deter-
mines to be necessary to allow the Administrator to
determine and apportion fees under this subsection, to de-
lSo in original (as added by sec. 232(2) of P.L. 104-170). Probably should be "Human".
2 Sec. 501(aXD of P.L. 104-170 amended paras. (5XH) and (6) of sec. 4(i) (7 U.S.C. 136a-l(i))
by striking "1997" and inserting "2001", without specifying the Act that was being amended.
The amendments were executed to this Act to effectuate the probable intent of Congress.
-------
Sec. 4 FIFRA 54
termine the registrant's eligibility for a reduction or waiv-
er of a fee, or to determine the volume usage for public
health pesticides.
(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 sub-
section, 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 reappor-
tion 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)) regard-
ing data concerning an active ingredient and fees for review of such
data shall not apply to any person who is the registrant of a pes-
ticide 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 reg-
istration 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 which shall be known as the Reregistration
and Expedited Processing Fund.l
(2)2 SOURCE AND USE.—
(A) All moneys derived from fees collected by the Ad-
ministrator under subsection (i) shall be deposited in the
fund and shall be available to the Administrator, without
fiscal year limitation, specifically to offset the costs of re-
registration and expedited processing of the applications
specified in paragraph (3). Such moneys derived from fees
may not be expended in any fiscal year to the extent such
moneys derived from fees would exceed money appro-
priated for use by the Administrator and expended in such
year for such costs of reregistration and expedited process-
ing of such applications. The Administrator shall, prior to
expending any such moneys derived from fees—
(i) effective October 1, 1997, adopt specific and
cost accounting rules and procedures as approved by
the General Accounting Office and the Inspector Gen-
eral of the Environmental Protection Agency to ensure
that moneys derived from fees are allocated solely to
the costs of reregistration and expedited processing of
iSec. 501(b) of P.L. 104-170 amended sec. 4(kXD (7 U.S.C. 136a-l(k)(l)) by inserting "which
shall be known as the Reregistration and Expedited Processing Fund", without specifying the
Act that was being amended. The amendment was executed to this Act to effectuate the prob-
able intent of Congress.
2 Sec. 501(c) of P.L. 104-170 amended sec. 4(k)(2) (7 U.S.C. 136a-l(k)(2)) to read as provided
above, without specifying the Act that was being amended. The amendment was executed to this
Act to effectuate the probable intent of Congress.
-------
55 FIFRA Sec. 4
the applications specified in paragraph (3) in the same
portion as appropriated funds;
(ii) prohibit the use of such moneys derived from
fees to pay for any costs other than those necessary to
achieve reregistration and expedited processing of the
applications specified in paragraph (3); and
(iii) ensure that personnel and facility costs associ-
ated with the functions to be carried out under this
paragraph do not exceed agency averages for com-
parable personnel and facility costs.
(B) The Administrator shall also—
(i) complete the review of unreviewed reregistra-
tion studies required to support the reregistration eli-
gibility decisions scheduled for completion in accord-
ance with subsection (1)(2); and
(ii) contract for such outside assistance as may be
necessary for review of required studies, using a gen-
erally accepted competitive process for the selection of
vendors of such assistance.
(3) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.—
(A) The Administrator shall use for each of the fiscal
years 1997 through 2001, not more than Vi of the mainte-
nance fees collected in such fiscal year1 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 composi-
tion and labeling to a currently-registered pesticide
identified in the application, or that would differ in
composition and labeling from any such currently-reg-
istered pesticide only in ways that would not signifi-
cantly increase the risk of unreasonable adverse ef-
fects on the environment;
(ii) proposes an amendment to the registration of
a registered pesticide that does not require scientific
review of data; or
(iii) proposes the initial or amended registration of
an end use pesticide that, if registered as proposed,
would be used for a public health pesticide.
(B) Any amounts made available under subparagraph
(A) shall be used to obtain sufficient personnel and re-
sources to carry out the activities described in such sub-
paragraph that are in addition to the personnel and re-
sources available to carry out such activities on the date
of enactment of this section.
iSec. 501(d)(l) of P.L. 104-170 amended sec. 4(k)(3) (7 U.S.C. 136a-l(kX3)) by striking "for
each of the fiscal years 1992, 1993, and 1994, Yrih of the maintenance fees collected, up to 2
million each year" and inserting "for each of the fiscal years 1997 through 2001, not more than
Yi of the maintenance fees collected in such fiscal year", without specifying the Act that was
being amended and without including a $ before "2 million". The amendment was executed to
this Act, and to strike "$2 million", to effectuate the probable intent of Congress.
-------
Sec. 4 FIFRA 56
(C)1 So long as the Administrator has not met the
time frames specified in clause (ii) of section 3(c)(3)(B) with
respect to any application subject to section 3(c)(3)(B) that
was received prior to the date of enactment of the Food
Quality Protection Act of 1996, the Administrator shall use
the full amount of the fees specified in subparagraph (A)
for the purposes specified therein. Once all applications
subject to section 3(c)(3)(B) that were received prior to
such date of enactment have been acted upon, no limita-
tion shall be imposed by the preceding sentence of this
subparagraph so long as the Administrator meets the time
frames specified in clause (ii) of section 3(c)(3)(B) on 90
percent of affected applications in a fiscal year. Should the
Administrator not meet such time frames in a fiscal year,
the limitations imposed by the first sentence of this sub-
paragraph shall apply until all overdue applications sub-
ject to section 3(c)(3)(B) have been acted upon.
(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 in-
struments that are lawful investments for fiduciary, trust,
or public funds.
(5)2 ACCOUNTING AND PERFORMANCE.—The Administrator
shall take all steps necessary to ensure that expenditures from
fees authorized by subsection (i)(5)(C)(ii) are used only to carry
out the goals established under subsection (1). The Reregistra-
tion and Expedited Processing Fund shall be designated as an
Environmental Protection Agency component for purposes of
section 3515(c) of title 31, United States Code. The annual
audit required under section 3521 of such title of the financial
statements of activities under this Act under section 3515(b) of
such title shall include an audit of the fees collected under sub-
section (i)(5)(C) and disbursed, of the amount appropriated to
match such fees, and of the Administrator's attainment of per-
formance measures and goals established under subsection (1).
Such an audit shall also include a review of the reasonableness
of the overhead allocation and adequacy of disclosures of direct
and indirect costs associated with carrying out the reregistra-
tion and expedited processing of the applications specified in
paragraph (3), and the basis for and accuracy of all costs paid
with moneys derived from such fees. The Inspector General
shall conduct the annual audit and report the findings and rec-
ommendations of such audit to the Administrator and to the
Committees on Agriculture of the House of Representatives
iSec. 501(dX2) of P.L. 104-170 added subpara. (C) to sec. 4(k)(3) (7 U.S.C. 136a-l(k)(3)), with-
out specifying the Act that was being amended. The amendment was executed to this Act to
effectuate the probable intent of Congress.
2 Sec. 501(e) of P.L. 104-170 amended sec. 4(kX5) (7 U.S.C. 136a-l(k)(5)) to read as provided
above, without specifying the Act that was being amended. The amendment was executed to this
Act to effectuate the probable intent of Congress.
-------
57 FIFRA Sec. 4
and the Senate. The cost of such audit shall be paid for out of
the fees collected under subsection (i)(5)(C).
(I)1 PERFORMANCE MEASURES AND GOAL.—The Administrator
shall establish and publish annually in the Federal Register per-
formance measures and goals. Such measures and goals shall in-
clude—
(1) the number of products reregistered, canceled, or
amended, the status of reregistration, the number and type of
data requests under section 3(c)(2)(B) issued to support product
reregistration by active ingredient, the progress in reducing
the number of unreviewed, required reregistration studies, the
aggregate status of tolerances reassessed, and the number of
applications for registration submitted under subsection (k)(3)
that were approved or disapproved;
(2) the future schedule for reregistrations, including the
projection for such schedules that will be issued under sub-
section (g)(2)(A) and (B) in the current fiscal year and the suc-
ceeding fiscal year; and
(3) the projected year of completion of the reregistrations
under this section.
(m) 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).
(n) AUTHORIZATION OF FUNDS To DEVELOP PUBLIC HEALTH
DATA.—
(1) DEFINITION.—For the purposes of this section, "Sec-
retary" means the Secretary of Health and Human Services,
acting through the Public Health Service.
(2) CONSULTATION.—In the case of a pesticide registered
for use in public health programs for vector control or for other
uses the Administrator determines to be human health protec-
tion uses, the Administrator shall, upon timely request by the
registrant or any other interested person, or on the Adminis-
trator's own initiative may, consult with the Secretary prior to
taking final action to suspend registration under section
3(c)(2)(B)(iv), or cancel a registration under section 4, 6(e), or
6(f). In consultation with the Secretary, the Administrator
shall prescribe the form and content of requests under this sec-
tion.
(3) BENEFITS TO SUPPORT FAMILY.—The Administrator,
after consulting with the Secretary, shall make a determina-
tion whether the potential benefits of continued use of the pes-
ticide for public health or health protection purposes are of
such significance as to warrant a commitment by the Secretary
to conduct or to arrange for the conduct of the studies required
by the Administrator to support continued registration under
section 3 or reregistration under section 4.
(4) ADDITIONAL TIME.—If the Administrator determines
that such a commitment is warranted and in the public inter-
est, the Administrator shall notify the Secretary and shall, to
1Sec. 501(f) of P.L. 104-170 amended sec. 4 (7 U.S.C. 136a-l) by redesignating subsecs. (1)
and (m) aa subsecs. (m) and (n), respectively, and inserting a new subsec. (1), without specifying
the Act that was being amended. The amendments were executed to this Act to effectuate the
probable intent of Congress.
-------
Sec. 5 FIFRA 58
the extent necessary, amend a notice issued under section
3(c)(2)(B) to specify additional reasonable time periods for sub-
mission of the data.
(5) ARRANGEMENTS.—The Secretary shall make such ar-
rangements for the conduct of required studies as the Sec-
retary finds necessary and appropriate to permit submission of
data in accordance with the time periods prescribed by the Ad-
ministrator. Such arrangements may include Public Health
Service intramural research activities, grants, contracts, or co-
operative agreements with academic, public health, or other or-
ganizations qualified by experience and training to conduct
such studies.
(6) SUPPORT.—The Secretary may provide for support of
the required studies using funds authorized to be appropriated
under this section, the Public Health Service Act, or other ap-
propriate authorities. After a determination is made under
subsection (d), the Secretary shall notify the Committees on
Appropriations of the House of Representatives and the Senate
of the sums required to conduct the necessary studies.
(7) AUTHORIZATION OF APPROPRIATIONS.—There is author-
ized to be appropriated to carry out the purposes of this section
$12,000,000 for fiscal year 1997, and such sums as may be nec-
essary for succeeding fiscal years.
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 de-
termination 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 ap-
plicant of such notification. The Administrator may issue an experi-
mental 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 ap-
plication for an experimental use permit may be filed at any time.
(b) TEMPORARY TOLERANCE LEVEL.—If the Administrator de-
termines that the use of a pesticide may reasonably be expected to
result in any residue on or in food or feed, the Administrator may
establish a temporary tolerance level for the residue of the pes-
ticide before issuing the experimental use permit.
(c) USE UNDER PERMIT.—Use of a pesticide under an experi-
mental use permit shall be under the supervision of the Adminis-
trator, and shall be subject to such terms and conditions and be for
such period of time as the Administrator may prescribe in the per-
mit.
(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 un-
-------
59 FIFRA Sec. 6
reasonable 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 experi-
mental use permit, at any time, if the Administrator finds that its
terms or conditions are being violated, or that its terms and condi-
tions are inadequate to avoid unreasonable adverse effects on the
environment.
(f) STATE ISSUANCE OF PERMITS.—Notwithstanding the fore-
going provisions of this section, the Administrator shall, under
such terms and conditions as the Administrator 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 ex-
perimental use permits under this section.
(g) EXEMPTION FOR AGRICULTURAL RESEARCH AGENCIES.—Not-
withstanding the foregoing provisions of this section, the Adminis-
trator may issue an experimental use permit for a pesticide to any
public or private agricultural research agency or educational insti-
tution which applies for such permit. Each permit shall not exceed
more than a one-year period or such other specific time as the Ad-
ministrator may prescribe. Such permit shall be issued under such
terms and conditions restricting the use of the pesticide as the Ad-
ministrator may require. Such pesticide may be used only by such
research agency or educational institution for purposes of experi-
mentation.
SEC. 6. [136d] ADMINISTRATIVE REVIEW; SUSPENSION.
(a) EXISTING STOCKS AND INFORMATION.—1
(1) EXISTING STOCKS.—The Administrator may permit the
continued sale and use of existing stocks of a pesticide whose
registration is suspended or canceled under this section, or sec-
tion 3 or 4, to such extent, under such conditions, and for such
uses as the Administrator determines that such sale or use is
not inconsistent with the purposes of this Act.
(2) INFORMATION.—If at any time after the registration of
a pesticide the registrant has additional factual information re-
garding unreasonable adverse effects on the environment of
the pesticide, the registrant shall submit such information to
the Administrator.
(b) CANCELLATION AND CHANGE IN CLASSIFICATION.—If it ap-
pears to the Administrator that a pesticide or its labeling or other
material required to be submitted does not comply with the provi-
sions of this Act or, when used in accordance with widespread and
commonly recognized practice, generally causes unreasonable ad-
verse effects on the environment, the Administrator may issue a
notice of the Administrator's intent either—
(1) to cancel its registration or to change its classification
together with the reasons (including the factual basis) for the
Administrator's action, or
'Sec. 106(aXD of P.L. 104-170 amended subsec. (a) by striking the heading and inserting "(a)
EXISTING STOCKS AND INFORMATION.—". The second subsec. designation for "(a)" was omitted
to effectuate the probable intent of Congress.
-------
Sec. 6 FIFRA 60
(2) to hold a hearing to determine whether or not its reg-
istration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In de-
termining whether to issue any such notice, the Administrator
shall include among those factors to be taken into account the im-
pact 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 Fed-
eral 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 Ad-
ministrator 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 not-
withstanding the foregoing 60-day time requirement. The time re-
quirements 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 deter-
mines 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 sub-
section (b) and of submission to the Scientific Advisory Panel pur-
suant to section 25(d) and proceed in accordance with subsection
(c). When a public health use is affected, the Secretary of Health
and Human Services should provide available benefits and use in-
formation, or an analysis thereof, in accordance with the proce-
dures followed and subject to the same conditions as the Secretary
of Agriculture in the case of agricultural pesticides. 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 ei-
ther (i) the registrant makes the necessary corrections, if possible,
or (ii) a request for a hearing is made by a person adversely af-
fected by the notice. In the event a hearing is held pursuant to
such a request or to the Administrator's determination under para-
graph (2), a decision pertaining to registration or classification is-
sued 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 commod-
ities, retail food prices, and otherwise on the agricultural economy,
and the Administrator shall publish in the Federal Register an
analysis of such impact.
(c) SUSPENSION.—
-------
61 FIFRA Sec. B
(1) ORDER.—If the Administrator determines that action is
necessary to prevent an imminent hazard during the time re-
quired for cancellation or change in classification proceedings,
the Administrator may, by order, suspend the registration of
the pesticide immediately. Except as provided in paragraph (3),
no order of suspension may be issued under this subsection un-
less the Administrator has issued, or at the same time issues,
a notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b). 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 ac-
cordance 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 sub-
mitted 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 offi-
cer need not be a certified hearing examiner. The presiding of-
ficer shall have ten days from the conclusion of the presen-
tation of evidence to submit recommended findings and conclu-
sions 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 de-
termines that an emergency exists that does not permit the
Administrator to hold a hearing before suspending, the Admin-
istrator may issue a suspension order in advance of notification
to the registrant. The Administrator may issue an emergency
order under this paragraph before issuing a notice of intention
to cancel the registration or change the classification of the
pesticide under subsection (b) and the Administrator shall pro-
ceed to issue the notice under subsection (b) within 90 days of
issuing an emergency order. If the Administrator does not
issue a notice under subsection (b) within 90 days of issuing
an emergency order, the emergency order shall expire. In the
case of an emergency order, 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 para-
graph 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 allotted 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 sus-
pension following a hearing shall be reviewable in accordance
-------
Sec. 6 FIFRA 62
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 Ad-
ministrator shall be subject to immediate review in an action
by the registrant or other interested person with the concur-
rence 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 ef-
fectiveness of the suspension order, pending the Administra-
tor'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 rel-
evant and material to the issues raised by the objections filed by
the applicant or other interested parties, or to the issues stated by
the Administrator, if the hearing is called by the Administrator
rather than by the filing of objections. Upon a showing of relevance
and reasonable scope of evidence sought by any party to a public
hearing, the Hearing Examiner shall issue a subpena to compel
testimony or production of documents from any person. The Hear-
ing Examiner shall be guided by the principles of the Federal Rules
of Civil Procedure in making any order for the protection of the
witness or the content of documents produced and shall order the
payment of reasonable fees and expenses as a condition to requir-
ing testimony of the witness. On contest, the subpena may be en-
forced by an appropriate United States district court in accordance
with the principles stated herein. Upon the request of any party to
a public hearing and when in the Hearing Examiner's judgment it
is necessary or desirable, the Hearing Examiner shall at any time
before the hearing record is closed refer to a Committee of the Na-
tional Academy of Sciences the relevant questions of scientific fact
involved in the public hearing. No member of any committee of the
National Academy of Sciences established to carry out the func-
tions of this section shall have a financial or other conflict of inter-
est with respect to any matter considered by such committee. The
Committee of the National Academy of Sciences shall report in
writing to the Hearing Examiner within 60 days after such referral
on these questions of scientific fact. The report shall be made pub-
lic and shall be considered as part of the hearing record. The Ad-
ministrator shall enter into appropriate arrangements with the Na-
tional Academy of Sciences to assure an objective and competent
scientific review of the questions presented to Committees of the
Academy and to provide such other scientific advisory services as
may be required by the Administrator for carrying out the purposes
of this Act. As soon as practicable after completion of the hearing
(including the report of the Academy) but not later than 90 days
thereafter, the Administrator shall evaluate the data and reports
-------
63 FIFRA Sec. 6
before the Administrator and issue an order either revoking the
Administrator's notice of intention issued pursuant to this section,
or shall issue an order either canceling the registration, changing
the classification, denying the registration, or requiring modifica-
tion of the labeling or packaging of the article. Such order shall be
based only on substantial evidence of record of such hearing and
shall set forth detailed findings of fact upon which the order is
based.
(e) CONDITIONAL REGISTRATION.—
(1) The Administrator shall issue a notice of intent to can-
cel a registration issued under section 3(c)(7) of this Act if (A)
the Administrator, at any time during the period provided for
satisfaction of any condition imposed, determines that the reg-
istrant has failed to initiate and pursue appropriate action to-
ward fulfilling any condition imposed, or (B) at the end of the
period provided for satisfaction of any condition imposed, that
condition has not been met. The Administrator may permit the
continued sale and use of existing stocks of a pesticide whose
conditional registration has been canceled under this sub-
section to such extent, under such conditions, and for such uses
as the Administrator may specify if the Administrator deter-
mines that such sale or use is not inconsistent with the pur-
poses of this Act and will not have unreasonable adverse ef-
fects on the environment.
(2) A cancellation proposed under this subsection shall be-
come final and effective at the end of thirty days from receipt
by the registrant of the notice of intent to cancel unless during
that time a request for hearing is made by a person adversely
affected by the notice. If a hearing is requested, a hearing shall
be conducted under subsection (d) of this section. The only
matters for resolution at that hearing shall be whether the reg-
istrant has initiated and pursued appropriate action to comply
with the condition or conditions within the time provided or
whether the condition or conditions have been satisfied within
the time provided, and whether the Administrators determina-
tion with respect to the disposition of existing stocks is consist-
ent with this Act. A decision after completion of such hearing
shall be final. Notwithstanding any other provision of this sec-
tion, a hearing shall be held and a determination made within
seventy-five days after receipt of a request for such hearing.
(f) GENERAL PROVISIONS.—
(1) VOLUNTARY CANCELLATION.—
(A) A registrant may, at any time, request that a pes-
ticide registration of the registrant be canceled or amended
to terminate one or more pesticide uses.
(B) Before acting on a request under subparagraph
(A), the Administrator shall publish in the Federal Reg-
ister a notice of the receipt of the request and provide for
a 30-day period in which the public may comment.
(C) In the case of a pesticide that is registered for a
minor agricultural use, if the Administrator determines
that the cancellation or termination of uses would ad-
versely affect the availability of the pesticide for use, the
Administrator—
-------
Sec. 6 FIFRA 64
(i) shall publish in the Federal Register a notice
of the receipt of the request and make reasonable ef-
forts to inform persons who so use the pesticide of the
request; and
(ii) may not approve or reject the request until the
termination of the 180-day period beginning on the
date of publication of the notice in the Federal Reg-
ister, except that the Administrator may waive the
180-day period upon the request of the registrant or if
the Administrator determines that the continued use
of the pesticide would pose an unreasonable adverse
effect on the environment.
(D) Subject to paragraph (3)(B), after complying with
this paragraph, the Administrator may approve or deny
the request.
(2) PUBLICATION OF NOTICE.—A notice of denial of registra-
tion, intent to cancel, suspension, or intent to suspend issued
under this Act or a notice issued under subsection (c)(4) or
(d)(5)(A) of section 4 shall be published in the Federal Register
and shall be sent by certified mail, return receipt requested, to
the registrant's or applicant's address of record on file with the
Administrator. If the mailed notice is returned to the Adminis-
trator as undeliverable at that address, if delivery is refused,
or if the Administrator otherwise is unable to accomplish deliv-
ery of the notice to the registrant or applicant after making
reasonable efforts to do so, the notice shall be deemed to have
been received by the registrant or applicant on the date the no-
tice was published in the Federal Register.
(3) TRANSFER OF REGISTRATION OF PESTICIDES REGISTERED
FOR MINOR AGRICULTURAL USES.—In the case of a pesticide that
is registered for a minor agricultural use:
(A) During the 180-day period referred to in paragraph
(l)(C)(ii), the registrant of the pesticide may notify the Ad-
ministrator of an agreement between the registrant and a
person or persons (including persons who so use the pes-
ticide) to transfer the registration of the pesticide, in lieu
of canceling or amending the registration to terminate the
use.
(B) An application for transfer of registration, in con-
formance with any regulations the Administrator may
adopt with respect to the transfer of the pesticide registra-
tions, must be submitted to the Administrator within 30
days of the date of notification provided pursuant to sub-
paragraph (A). If such an application is submitted, the Ad-
ministrator shall approve the transfer and shall not ap-
prove the request for voluntary cancellation or amendment
to terminate use unless the Administrator determines that
the continued use of the pesticide would cause an unrea-
sonable adverse effect on the environment.
(C) If the Administrator approves the transfer and the
registrant transfers the registration of the pesticide, the
Administrator shall not cancel or amend the registration
to delete the use or rescind the transfer of the registration,
during the 180-day period beginning on the date of the ap-
-------
65 FIFRA Sec. 7
proval of the transfer unless the Administrator determines
that the continued use of the pesticide would cause an un-
reasonable adverse effect on the environment.
(D) The new registrant of the pesticide shall assume
the outstanding data and other requirements for the pes-
ticide that are pending at the time of the transfer.
(4) UTILIZATION OF DATA FOR VOLUNTARILY CANCELED PES-
TICIDE.—When an application is filed with the Administrator
for the registration of a pesticide for a minor use and another
registrant subsequently voluntarily cancels its registration for
an identical or substantially similar pesticide for an identical
or substantially similar use, the Administrator shall process,
review, and evaluate the pending application as if the vol-
untary cancellation had not yet taken place except that the Ad-
ministrator shall not take such action if the Administrator de-
termines that such minor use may cause an unreasonable ad-
verse effect on the environment. In order to rely on this sub-
section, the applicant must certify that it agrees to satisfy any
outstanding data requirements necessary to support the rereg-
istration of the pesticide in accordance with the data submis-
sion schedule established by the Administrator.
(g) NOTICE FOR STORED PESTICIDES WITH CANCELED OR SUS-
PENDED REGISTRATIONS.—
(1) IN GENERAL.—Any producer or exporter of pesticides,
registrant of a pesticide, applicant for registration of a pes-
ticide, applicant for or holder of an experimental use permit,
commercial applicator, or any person who distributes or sells
any pesticide, who possesses any pesticide which has had its
registration canceled or suspended under this section shall no-
tify the Administrator and appropriate State and local officials
of—
(A) such possession,
(B) the quantity of such pesticide such person pos-
sesses, and
(C) the place at which such pesticide is stored.
(2) COPIES.—The Administrator shall transmit a copy of
each notice submitted under this subsection to the regional of-
fice of the Environmental Protection Agency which has juris-
diction over the place of pesticide storage identified in the no-
tice.
(h) JUDICIAL REVIEW.—Final orders of the Administrator under
this section shall be subject to judicial review pursuant to section
16.
SEC. 7. [136e] REGISTRATION OF ESTABLISHMENTS.
(a) REQUIREMENT.—No person shall produce any pesticide sub-
ject to this Act or active ingredient used in producing a pesticide
subject to this Act in any State unless the establishment in which
it is produced is registered with the Administrator. The application
for registration of any establishment shall include the name and
address of the establishment and of the producer who operates
such establishment.
-------
Sec. 7 FIFRA 66
(b) REGISTRATION.—Whenever the Administrator receives an
application under subsection (a), the Administrator shall register
the establishment and assign it an establishment number.
(c) INFORMATION REQUIRED.—
(1) Any producer operating an establishment registered
under this section shall inform the Administrator within 30
days after it is registered of the types and amounts of pes-
ticides and, if applicable, active ingredients used in producing
pesticides—
(A) which the producer is currently producing;
(B) which the producer has produced during the past
year; and
(C) which the producer has sold or distributed during
the past year.
The information required by this paragraph shall be kept cur-
rent and submitted to the Administrator annually as required
under such regulations as the Administrator may prescribe.
(2) Any such producer shall, upon the request of the Ad-
ministrator for the purpose of issuing a stop sale order pursu-
ant to section 13, inform the Administrator of the name and
address of any recipient of any pesticide produced in any reg-
istered establishment which the producer operates.
(d) CONFIDENTIAL RECORDS AND INFORMATION.—Any informa-
tion submitted to the Administrator pursuant to subsection (c)
other than the names of the pesticides or active ingredients used
in producing pesticides produced, sold, or distributed at an estab-
lishment shall be considered confidential and shall be subject to the
provisions of section 10.
SEC. 8. [136f] BOOKS AND RECORDS.
(a) REQUIREMENTS.—The Administrator may prescribe regula-
tions requiring producers, registrants, and applicants for registra-
tion to maintain such records with respect to their operations and
the pesticides and devices produced as the Administrator deter-
mines are necessary for the effective enforcement of this Act and
to make the records available for inspection and copying in the
same manner as provided in subsection (b). No records required
under this subsection shall extend to financial data, sales data
other than shipment data, pricing data, personnel data, and re-
search data (other than data relating to registered pesticides or to
a pesticide for which an application for registration has been filed).
(b) INSPECTION.—For the purposes of enforcing the provisions
of this Act, any producer, distributor, carrier, dealer, or any other
person who sells or offers for sale, delivers or offers for delivery any
pesticide or device subject to this Act, shall, upon request of any
officer or employee of the Environmental Protection Agency or of
any State or political subdivision, duly designated by the Adminis-
trator, furnish or permit such person at all reasonable times to
have access to, and to copy: (1) all records showing the delivery,
movement, or holding of such pesticide or device, including the
quantity, the date of shipment and receipt, and the name of the
consignor and consignee; or (2) in the event of the inability of any
person to produce records containing such information, all other
records and information relating to such delivery, movement, or
-------
67 FIFRA Sec. 9
holding of the pesticide or device. Any inspection with respect to
any records and information referred to in this subsection shall not
extend to financial data, sales data other than shipment data, pric-
ing data, personnel data, and research data (other than data relat-
ing to registered pesticides or to a pesticide for which an applica-
tion for registration has been filed). Before undertaking an inspec-
tion under this subsection, the officer or employee must present to
the owner, operator, or agent in charge of the establishment or
other place where pesticides or devices are held for distribution or
sale, appropriate credentials and a written statement as to the rea-
son for the inspection, including a statement as to whether a viola-
tion of the law is suspected. If no violation is suspected, an alter-
nate and sufficient reason shall be given in writing. Each such in-
spection shall be commenced and completed with reasonable
promptness.
SEC. 9. [136g] INSPECTION OF ESTABLISHMENTS, ETC.
(a) IN GENERAL.—(1) For purposes of enforcing the provisions
of this Act, officers or employees of the Environmental Protection
Agency or of any State duly designated by the Administrator are
authorized to enter at reasonable times (A) any establishment or
other place where pesticides or devices are held for distribution or
sale for the purpose of inspecting and obtaining samples of any pes-
ticides or devices, packaged, labeled, and released for shipment,
and samples of any containers or labeling for such pesticides or de-
vices, or (B) any place where there is being held any pesticide the
registration of which has been suspended or canceled for the pur-
pose of determining compliance with section 19.
(2) Before undertaking such inspection, the officers or employ-
ees must present to the owner, operator, or agent in charge of the
establishment or other place where pesticides or devices are held
for distribution or sale, appropriate credentials and a written state-
ment as to the reason for the inspection, including a statement as
to whether a violation of the law is suspected. If no violation is sus-
pected, an alternate and sufficient reason shall be given in writing.
Each such inspection shall be commenced and completed with rea-
sonable promptness. If the officer or employee obtains any samples,
prior to leaving the premises, the officer or employee shall give to
the owner, operator, or agent in charge a receipt describing the
samples obtained and, if requested, a portion of each such sample
equal in volume or weight to the portion retained. If an analysis
is made of such samples, a copy of the results of such analysis shall
be furnished promptly to the owner, operator, or agent in charge.
(b) WARRANTS.—For purposes of enforcing the provisions of
this Act and upon a showing to an officer or court of competent ju-
risdiction that there is reason to believe that the provisions of this
Act have been violated, officers or employees duly designated by
the Administrator are empowered to obtain and to execute war-
rants authorizing—
(1) entry, inspection, and copying of records for purposes of
this section or section 8;
(2) inspection and reproduction of all records showing the
quantity, date of shipment, and the name of consignor and con-
signee of any pesticide or device found in the establishment
-------
Sec. 10 FIFRA 68
which is adulterated, misbranded, not registered (in the case
of a pesticide) or otherwise in violation of this Act and in the
event of the inability of any person to produce records contain-
ing such information, all other records and information relat-
ing to such delivery, movement, or holding of the pesticide or
device; and
(3) the seizure of any pesticide or device which is in viola-
tion of this Act.
(c) ENFORCEMENT.—
(1) CERTIFICATION OF FACTS TO ATTORNEY GENERAL.—The
examination of pesticides or devices shall be made in the Envi-
ronmental Protection Agency or elsewhere as the Adminis-
trator may designate for the purpose of determining from such
examinations whether they comply with the requirements of
this Act. If it shall appear from any such examination that
they fail to comply with the requirements of this Act, the Ad-
ministrator shall cause notice to be given to the person against
whom criminal or civil proceedings are contemplated. Any per-
son so notified shall be given an opportunity to present the
person's views, either orally or in writing, with regard to such
contemplated proceedings, and if in the opinion of the Adminis-
trator it appears that the provisions of this Act have been vio-
lated by such person, then the Administrator shall certify the
facts to the Attorney General, with a copy of the results of the
analysis or the examination of such pesticide for the institution
of a criminal proceeding pursuant to section 14(b) or a civil
proceeding under section 14(a), when the Administrator deter-
mines that such action will be sufficient to effectuate the pur-
poses of this Act.
(2) NOTICE NOT REQUIRED.—The notice of contemplated
proceedings and opportunity to present views set forth in this
subsection are not prerequisites to the institution of any pro-
ceeding by the Attorney General.
(3) WARNING NOTICES.—Nothing in this Act shall be con-
strued as requiring the Administrator to institute proceedings
for prosecution of minor violations of this Act whenever the Ad-
ministrator believes that the public interest will be adequately
served by a suitable written notice of warning.
SEC. 10. [136h] PROTECTION OF TRADE SECRETS AND OTHER INFOR-
MATION.
(a) IN GENERAL.—In submitting data required by this Act, the
applicant may (1) clearly mark any portions thereof which in the
applicant's opinion are trade secrets or commercial or financial in-
formation and (2) submit such marked material separately from
other material required to be submitted under this Act.
(b) DISCLOSURE.—Notwithstanding any other provision of this
Act and subject to the limitations in subsections (d) and (e) of this
section, the Administrator shall not make public information which
in the Administrator's judgment contains or relates to trade secrets
or commercial or financial information obtained from a person and
privileged or confidential, except that, when necessary to carry out
the provisions of this Act, information relating to formulas of prod-
ucts acquired by authorization of this Act may be revealed to any
-------
69 FIFRA Sec. 10
Federal agency consulted and may be revealed at a public hearing
or in findings of fact issued by the Administrator.
(c) DISPUTES.—If the Administrator proposes to release for in-
spection information which the applicant or registrant believes to
be protected from disclosure under subsection (b), the Adminis-
trator shall notify the applicant or registrant, in writing, by cer-
tified mail. The Administrator shall not thereafter make available
for inspection such data until thirty days after receipt of the notice
by the applicant or registrant. During this period, the applicant or
registrant may institute an action in an appropriate district court
for a declaratory judgment as to whether such information is sub-
ject to protection under subsection (b).
(d) LIMITATIONS.—
(1) All information concerning the objectives, methodology,
results, or significance of any test or experiment performed on
or with a registered or previously registered pesticide or its
separate ingredients, impurities, or degradation products, and
any information concerning the effects of such pesticide on any
organism or the behavior of such pesticide in the environment,
including, but not limited to, data on safety to fish and wildlife,
humans and other mammals, plants, animals, and soil, and
studies on persistence, translocation and fate in the environ-
ment, and metabolism, shall be available for disclosure to the
public. The use of such data for any registration purpose shall
be governed by section 3 of this Act. This paragraph does not
authorize the disclosure of any information that—
(A) discloses manufacturing or quality control proc-
esses,
(B) discloses the details of any methods for testing, de-
tecting, or measuring the quantity of any deliberately
added inert ingredient of a pesticide, or
(C) discloses the identity or percentage quantity of any
deliberately added inert ingredient of a pesticide,
unless the Administrator has first determined that disclosure
is necessary to protect against an unreasonable risk of injury
to health or the environment.
(2) Information concerning production, distribution, sale,
or inventories of a pesticide that is otherwise entitled to con-
fidential treatment under subsection (b) of this section may be
publicly disclosed in connection with a public proceeding to de-
termine whether a pesticide, or any ingredient of a pesticide,
causes unreasonable adverse effects on health or the environ-
ment, if the Administrator determines that such disclosure is
necessary in the public interest.
(3) If the Administrator proposes to disclose information
described in clause (A), (B), or (C) of paragraph (1) or in para-
graph (2) of this subsection, the Administrator shall notify by
certified mail the submitter of such information of the intent
to release such information. The Administrator may not re-
lease such information, without the submitter's consent, until
thirty days after the submitter has been furnished such notice.
Where the Administrator finds that disclosure of information
described in clause (A), (B), or (C) of paragraph (1) of this sub-
section is necessary to avoid or lessen an imminent and sub-
-------
Sec. 10 FIFRA 70
stantial risk of injury to the public health, the Administrator
may set such shorter period of notice (but not less than ten
days) and such method of notice as the Administrator finds ap-
propriate. During such period the data submitter may institute
an action in an appropriate district court to enjoin or limit the
proposed disclosure. The court may enjoin disclosure, or limit
the disclosure or the parties to whom disclosure shall be made,
to the extent that—
(A) in the case of information described in clause (A),
(B), or (C) of paragraph (1) of this subsection, the proposed
disclosure is not required to protect against an unreason-
able risk of injury to health or the environment; or
(B) in the case of information described in paragraph
(2) of this subsection, the public interest in availability of
the information in the public proceeding does not outweigh
the interests in preserving the confidentiality of the infor-
mation.
(e) DISCLOSURE TO CONTRACTORS.—Information otherwise pro-
tected from disclosure to the public under subsection (b) of this sec-
tion may be disclosed to contractors with the United States and
employees of such contractors if, in the opinion of the Adminis-
trator, such disclosure is necessary for the satisfactory performance
by the contractor of a contract with the United States for the per-
formance of work in connection with this Act and under such condi-
tions as the Administrator may specify. The Administrator shall re-
quire as a condition to the disclosure of information under this sub-
section that the person receiving it take such security precautions
respecting the information as the Administrator shall by regulation
prescribe.
(f) PENALTY FOR DISCLOSURE BY FEDERAL EMPLOYEES.—(1)
Any office or employee of the United States or former officer or em-
ployee of the United States who, by virtue of such employment or
official position, has obtained possession of, or has access to, mate-
rial the disclosure of which is prohibited by subsection (b) of this
section, and who, knowing that disclosure of such material is pro-
hibited by such subsection, willfully discloses the material in any
manner to any person not entitled to receive it, shall be fined not
more than $10,000 or imprisoned for not more than one year, or
both. Section 1905 of title 18 of the United States Code shall not
apply with respect to the publishing, divulging, disclosure, or mak-
ing known of, or making available, information reported or other-
wise obtained under this Act. Nothing in this Act shall preempt
any civil remedy under State or Federal law for wrongful disclosure
of trade secrets.
(2) For the purposes of this section, any contractor with the
United States who is furnished information as authorized by sub-
section (e) of this section, or any employee of any such contractor,
shall be considered to be an employee of the United States.
(g) DISCLOSURE TO FOREIGN AND MULTINATIONAL PESTICIDE
PRODUCERS.—(1) The Administrator shall not knowingly disclose
information submitted by an applicant or registrant under this Act
to any employee or agent of any business or other entity engaged
in the production, sale, or distribution of pesticides in countries
other than the United States or in addition to the United States
-------
71 FIFRA Sec. 11
or to any other person who intends to deliver such data to such for-
eign or multinational business or entity unless the applicant or reg-
istrant has consented to such disclosure. The Administrator shall
require an affirmation from any person who intends to inspect data
that such person does not seek access to the data for purposes of
delivering it or offering it for sale to any such business or entity
or its agents or employees and will not purposefully deliver or neg-
ligently cause the data to be delivered to such business or entity
or its agents or employees. Notwithstanding any other provision of
this subsection, the Administrator may disclose information to any
person in connection with a public proceeding under law or regula-
tion, subject to restrictions on the availability of information con-
tained elsewhere in this Act, which information is relevant to a de-
termination by the Administrator with respect to whether a pes-
ticide, or any ingredient of a pesticide, causes unreasonable adverse
effects on health or the environment.
(2) The Administrator shall maintain records of the names of
persons to whom data are disclosed under this subsection and the
persons or organizations they represent and shall inform the appli-
cant or registrant of the names and affiliations of such persons.
(3) Section 1001 of title 18 of the United States Code shall
apply to any affirmation made under paragraph (1) of this sub-
section.
SEC. 11. [136i] USE OF RESTRICTED USE PESTICIDES; APPLICATORS.
(a) CERTIFICATION PROCEDURE.—
(1) FEDERAL CERTIFICATION.—In any State for which a
State plan for applicator certification has not been approved by
the Administrator, the Administrator, in consultation with the
Governor of such State, shall conduct a program for the certifi-
cation of applicators of pesticides. Such program shall conform
to the requirements imposed upon the States under the provi-
sions of subsection (a)(2) of this section and shall not require
private applicators to take any examination to establish com-
petency in the use of pesticides. Prior to the implementation of
the program, the Administrator shall publish in the Federal
Register for review and comment a summary of the Federal
plan for applicator certification and shall make generally avail-
able within the State copies of the plan. The Administrator
shall hold public hearings at one or more locations within the
State if so requested by the Governor of such State during the
thirty days following publication of the Federal Register notice
inviting comment on the Federal plan. The hearings shall be
held within thirty days following receipt of the request from
the Governor. In any State in which the Administrator con-
ducts a certification program, the Administrator may require
any person engaging in the commercial application, sale, offer-
ing for sale, holding for sale, or distribution of any pesticide
one or more uses of which have been classified for restricted
use to maintain such records and submit such reports concern-
ing the commercial application, sale, or distribution of such
pesticide as the Administrator may be regulation prescribe.
Subject to paragraph (2), the Administrator shall prescribe
standards for the certification of applicators of pesticides. Such
-------
Sec. 11 FIFRA 72
standards shall provide that to be certified, an individual must
be determined to be competent with respect to the use and
handling of pesticides, or to the use and handling of the pes-
ticide or class of pesticides covered by such individual's certifi-
cation. The certification standard for a private applicator shall,
under a State plan submitted for approval, be deemed fulfilled
by the applicator completing a certification form. The Adminis-
trator shall further assure that such form contains adequate
information and affirmations to carry out the intent of this Act,
and may include in the form an affirmation that the private
applicator has completed a training program approved by the
Administrator so long as the program does not require the pri-
vate applicator to take, pursuant to a requirement prescribed
by the Administrator, any examination to establish competency
in the use of the pesticide. The Administrator may require any
pesticide dealer participating in a certification program to be
licensed under a State licensing program approved by the Ad-
ministrator.
(2) STATE CERTIFICATION.—If any State, at any time, de-
sires to certify applicators of pesticides, the Governor of such
State shall submit a State plan for such purpose. The Adminis-
trator shall approve the plan submitted by any State, or any
modification thereof, if such plan in the Administrator's judg-
ment—
(A) designates a State agency as the agency respon-
sible for administering the plan throughout the State;
(B) contains satisfactory assurances that such agency
has or will have the legal authority and qualified person-
nel necessary to carry out the plan;
(C) gives satisfactory assurances that the State will
devote adequate funds to the administration of the plan;
(D) provides that the State agency will make such re-
ports to the Administrator in such form and containing
such information as the Administrator may from time to
time require; and
(E) contains satisfactory assurances that State stand-
ards for the certification of applicators of pesticides con-
form with those standards prescribed by the Administrator
under paragraph (1).
Any State certification program under this section shall be
maintained in accordance with the State plan approved under
this section.
(b) STATE PLANS.—If the Administrator rejects a plan submit-
ted under subsection (a)(2), the Administrator shall afford the
State submitting the plan due notice and opportunity for hearing
before so doing. If the Administrator approves a plan submitted
under subsection (a)(2), then such State shall certify applicators of
pesticides with respect to such State. Whenever the Administrator
determines that a State is not administering the certification pro-
gram in accordance with the plan approved under this section, the
Administrator shall so notify the State and provide for a hearing
at the request of the State, and, if appropriate corrective action is
not taken within a reasonable time, not to exceed ninety days, the
Administrator shall withdraw approval of such plan.
-------
73 FIFRA Sec. 12
(c) INSTRUCTION IN INTEGRATED PEST MANAGEMENT TECH-
NIQUES.—Standards prescribed by the Administrator for the certifi-
cation of applicators of pesticides under subsection (a), and the
State plans submitted to the Administrator under subsection (a),
shall include provisions for making instructional materials concern-
ing integrated pest management techniques available to individ-
uals at their request in accordance with the provisions of section
23(c) of this Act, but such plans may not require that any individ-
ual receive instruction concerning such techniques or be shown to
be competent with respect to the use of such techniques. The Ad-
ministrator and States implementing such plans shall provide that
all interested individuals are notified of the availability of such in-
structional materials.
(d) IN GENERAL.—No regulations prescribed by the Adminis-
trator for carrying out the provisions of this Act shall require any
private applicator to maintain any records or file any reports or
other documents.
(e) SEPARATE STANDARDS.—When establishing or approving
standards for licensing or certification, the Administrator shall es-
tablish separate standards for commercial and private applicators.
SEC. 12. [136j] UNLAWFUL ACTS.
(a) IN GENERAL.—
(1) Except as provided by subsection (b), it shall be unlaw-
ful for any person in any State to distribute or sell to any per-
son—
(A) any pesticide that is not registered under section
3 or whose registration has been canceled or suspended,
except to the extent that distribution or sale otherwise has
been authorized by the Administrator under this Act;
(B) any registered pesticide if any claims made for it
as a part of its distribution or sale substantially differ
from any claims made for it as a part of the statement re-
quired in connection with its registration under section 3;
(C) any registered pesticide the composition of which
differs at the time of its distribution or sale from its com-
position as described in the statement required in connec-
tion with its registration under section 3;
(D) any pesticide which has not been colored or discol-
ored pursuant to the provisions of section 25(c)(5);
(E) any pesticide which is adulterated or misbranded;
or
(F) any device which is misbranded.
(2) It shall be unlawful for any person—
(A) to detach, alter, deface, or destroy, in whole or in
part, any labeling required under this Act;
(B) to refuse to—
(i) prepare, maintain, or submit any records re-
quired by or under section 5, 7, 8, 11, or 19;
(ii) submit any reports required by or under sec-
tion 5, 6, 7, 8, 11, or 19; or
(iii) allow any entry, inspection, copying of
records, or sampling authorized by this Act;
-------
Sec. 12 FIFRA 74
(C) to give a guaranty or undertaking provided for in
subsection (b) which is false in any particular, except that
a person who receives and relies upon a guaranty author-
ized under subsection (b) may give a guaranty to the same
effect, which guaranty shall contain, in addition to the per-
son's own name and address, the name and address of the
person residing in the United States from whom the per-
son received the guaranty or undertaking;
(D) to use for the person's own advantage or to reveal,
other than to the Administrator, or officials or employees
of the Environmental Protection Agency or other Federal
executive agencies, or to the courts, or to physicians, phar-
macists, and other qualified persons, needing such infor-
mation for the performance of their duties, in accordance
with such directions as the Administrator may prescribe,
any information acquired by authority of this Act which is
confidential under this Act;
(E) who is a registrant, wholesaler, dealer, retailer, or
other distributor to advertise a product registered under
this Act for restricted use without giving the classification
of the product assigned to it under section 3;
(F) to distribute or sell, or to make available for use,
or to use, any registered pesticide classified for restricted
use for some or all purposes other than in accordance with
section 3(d) and any regulations thereunder, except that it
shall not be unlawful to sell, under regulations issued by
the Administrator, a restricted use pesticide to a person
who is not a certified applicator for application by a cer-
tified applicator;
(G) to use any registered pesticide in a manner incon-
sistent with its labeling;
(H) to use any pesticide which is under an experi-
mental use permit contrary to the provisions of such per-
mit;
(I) to violate any order issued under section 13;
(J) to violate any suspension order issued under sec-
tion 3(c)(2)(B), 4, or 6;
(K) to violate any cancellation order issued under this
Act or to fail to submit a notice in accordance with section
6(g);
(L) who is a producer to violate any of the provisions
of section 7;
(M) to knowingly falsify all or part of any application
for registration, application for experimental use permit,
any information submitted to the Administrator pursuant
to section 7, any records required to be maintained pursu-
ant to this Act, any report filed under this Act, or any in-
formation marked as confidential and submitted to the Ad-
ministrator under any provision of this Act;
(N) who is a registrant, wholesaler, dealer, retailer, or
other distributor to fail to file reports required by this Act;
(O) to add any substance to, or take any substance
from, any pesticide in a manner that may defeat the pur-
pose of this Act;
-------
75 FIFRA Sec. 13
(P) to use any pesticide in tests on human beings un-
less such human beings (i) are fully informed of the nature
and purposes of the test and of any physical and mental
health consequences which are reasonably foreseeable
therefrom, and (ii) freely volunteer to participate in the
test;
(Q) to falsify all or part of any information relating to
the testing of any pesticide (or any ingredient, metabolite,
or degradation product thereof), including the nature of
any protocol, procedure, substance, organism, or equip-
ment used, observation made, or conclusion or opinion
formed, submitted to the Administrator, or that the person
knows will be furnished to the Administrator or will be-
come a part of any records required to be maintained by
this Act;
(R) to submit to the Administrator data known to be
false in support of a registration; or
(S) to violate any regulation issued under section 3(a)
or 19.
(b) EXEMPTIONS.—The penalties provided for a violation of
paragraph (1) of subsection (a) shall not apply to—
(1) any person who establishes a guaranty signed by, and
containing the name and address of, the registrant or person
residing in the United States from whom the person purchased
or received in good faith the pesticide in the same unbroken
package, to the effect that the pesticide was lawfully registered
at the time of sale and delivery to the person, and that it com-
plies with the other requirements of this Act, and in such case
the guarantor shall be subject to the penalties which would
otherwise attach to the person holding the guaranty under the
provisions of this Act;
(2) any carrier while lawfully shipping, transporting, or de-
livering for shipment any pesticide or device, if such carrier
upon request of any officer or employee duly designated by the
Administrator shall permit such officer or employee to copy all
of its records concerning such pesticide or device;
(3) any public official while engaged in the performance of
the official duties of the public official;
(4) any person using or possessing any pesticide as pro-
vided by an experimental use permit in effect with respect to
such pesticide and such use or possession; or
(5) any person who ships a substance or mixture of sub-
stances being put through tests in which the purpose is only
to determine its value for pesticide purposes or to determine its
toxicity or other properties and from which the user does not
expect to receive any benefit in pest control from its use.
SEC. 13. [136k] STOP SALE, USE, REMOVAL, AND SEIZURE.
(a) STOP SALE, ETC., ORDERS.—Whenever any pesticide or de-
vice is found by the Administrator in any State and there is reason
to believe on the basis of inspection or tests that such pesticide or
device is in violation of any of the provisions of this Act, or that
such pesticide or device has been or is intended to be distributed
or sold in violation of any such provisions, or when the registration
-------
Sec. 13 FIFRA 76
of the pesticide has been canceled by a final order or has been sus-
pended, the Administrator may issue a written or printed "stop
sale, use, or removal" order to any person who owns, controls, or
has custody of such pesticide or device, and after receipt of such
order no person shall sell, use, or remove the pesticide or device de-
scribed in the order except in accordance with the provisions of the
order.
(b) SEIZURE.—Any pesticide or device that is being transported
or, having been transported, remains unsold or in original unbro-
ken packages, or that is sold or offered for sale in any State, or
that is imported from a foreign country, shall be liable to be pro-
ceeded against in any district court in the district where it is found
and seized for confiscation by a process in rem for condemnation
if—
(1) in the case of a pesticide—
(A) it is adulterated or misbranded;
(B) it is not registered pursuant to the provisions of
section 3;
(C) its labeling fails to bear the information required
by this Act;
(D) it is not colored or discolored and such coloring or
discoloring is required under this Act; or
(E) any of the claims made for it or any of the direc-
tions for its use differ in substance from the representa-
tions made in connection with its registration;
(2) in the case of a device, it is misbranded; or
(3) in the case of a pesticide or device, when used in ac-
cordance with the requirements imposed under this Act and as
directed by the labeling, it nevertheless causes unreasonable
adverse effects on the environment.
In the case of a plant regulator, defoliant, or desiccant, used in ac-
cordance with the label claims and recommendations, physical or
physiological effects on plants or parts thereof shall not be deemed
to be injury, when such effects are the purpose for which the plant
regulator, defoliant, or desiccant was applied.
(c) DISPOSITION AFTER CONDEMNATION.—If the pesticide or de-
vice is condemned it shall, after entry of the decree, be disposed of
by destruction or sale as the court may direct and the proceeds, if
sold, less the court costs, shall be paid into the Treasury of the
United States, but the pesticide or device shall not be sold contrary
to the provisions of this Act or the laws of the jurisdiction in which
it is sold. On payment of the costs of the condemnation proceedings
and the execution and delivery of a good and sufficient bond condi-
tioned that the pesticide or device shall not be sold or otherwise
disposed of contrary to the provisions of the Act or the laws of any
jurisdiction in which sold, the court may direct that such pesticide
or device be delivered to the owner thereof. The proceedings of such
condemnation cases shall conform, as near as may be to the pro-
ceedings in admiralty, except that either party may demand trial
by jury of any issue of fact joined in any case, and all such proceed-
ings shall be at the suit of and in the name of the United States.
(d) COURT COSTS, ETC.—When a decree of condemnation is en-
tered against the pesticide or device, court costs and fees, storage,
-------
77 FIFRA Sec. 14
and other proper expenses shall be awarded against the person, if
any, intervening as claimant of the pesticide or device.
SEC. 14. [1361] PENALTIES.
(a) CIVIL PENALTIES.—
(1) IN GENERAL.—Any registrant, commercial applicator, whole-
saler, dealer, retailer, or other distributor who violates any
provision of this Act may be assessed a civil penalty by the Ad-
ministrator of not more than $5,000 for each offense.
(2) PRIVATE APPLICATOR.—Any private applicator or other
person not included in paragraph (1) who violates any provi-
sion of this Act subsequent to receiving a written warning from
the Administrator or following a citation for a prior violation,
may be assessed a civil penalty by the Administrator of not
more than $1,000 for each offense, except that any applicator
not included under paragraph (1) of this subsection who holds
or applies registered pesticides, or uses dilutions of registered
pesticides, only to provide a service of controlling pests without
delivering any unapplied pesticide to any person so served, and
who violates any provision of this Act may be assessed a civil
penalty by the Administrator of not more than $500 for the
first offense nor more than $1,000 for each subsequent offense.
(3) HEARING.—No civil penalty shall be assessed unless the
person charged shall have been given notice and opportunity
for a hearing on such charge in the county, parish, or incor-
porated city of the residence of the person charged.
BUDETERMINATION OF PENALTY.—In determining the
amount of the penalty, the Administrator shall consider the ap-
propriateness of such penalty to the size of the business of the
person charged, the effect on the person's ability to continue in
business, and the gravity of the violation. Whenever the Ad-
ministrator finds that the violation occurred despite the exer-
cise of due care or did not cause significant harm to health or
the environment, the Administrator may issue a warning in
lieu of assessing a penalty.
(5) REFERENCES TO ATTORNEY GENERAL.—In case of inabil-
ity to collect such civil penalty or failure of any person to pay
all, or such portion of such civil penalty as the Administrator
may determine, the Administrator shall refer the matter to the
Attorney General, who shall recover such amount by action in
the appropriate United States district court.
(b) CRIMINAL PENALTIES.—
(1) IN GENERAL.—
(A) Any registrant, applicant for a registration, or pro-
ducer who knowingly violates any provision of this Act
shall be fined not more than $50,000 or imprisoned for not
more than 1 year, or both.
(B) Any commercial applicator of a restricted use pes-
ticide, or any other person not described in subparagraph
(A) who distributes or sells pesticides or devices, who
knowingly violates any provision of this Act shall be fined
not more than $25,000 or imprisoned for not more than 1
year, or both.
-------
Sec. 15 FIFRA 78
(2) PRIVATE APPLICATOR.—Any private applicator or other
person not included in paragraph (1) who knowingly violates
any provision of this Act shall be guilty of a misdemeanor and
shall on conviction be fined not more than $1,000, or impris-
oned for not more than 30 days, or both.
(3) DISCLOSURE OF INFORMATION.—Any person, who, with
intent to defraud, uses or reveals information relative to for-
mulas of products acquired under the authority of section 3,
shall be fined not more than $10,000, or imprisoned for not
more than three years, or both.
(4) ACTS OF OFFICERS, AGENTS, ETC.—When construing and
enforcing the provisions of this Act, the act, omission, or failure
of any officer, agent, or other person acting for or employed by
any person shall in every case be also deemed to be the act,
omission, or failure of such person as well as that of the person
employed.
SEC. 15. [136m] INDEMNITIES.
(a) GENERAL INDEMNIFICATION.—
(1) IN GENERAL.—Except as otherwise provided in this sec-
tion, if—
(A) the Administrator notifies a registrant under sec-
tion 6(c)(l) that the Administrator intends to suspend a
registration or that an emergency order of suspension of a
registration under section 6(c)(3) has been issued;
(B) the registration in question is suspended under
section 6(c), and thereafter is canceled under section 6(b),
6(d), or 6(f); and
(C) any person who owned any quantity of the pes-
ticide immediately before the notice to the registrant
under subparagraph (A) suffered losses by reason of sus-
pension or cancellation of the registration;
the Administrator shall make an indemnity payment to the
person.
(2) EXCEPTION.—Paragraph (1) shall not apply if the Ad-
ministrator finds that the person—
(A) had knowledge of facts that, in themselves, would
have shown that the pesticide did not meet the require-
ments of section 3(c)(5) for registration; and
(B) continued thereafter to produce the pesticide with-
out giving timely notice of such facts to the Administrator.
(3) REPORT.—If the Administrator takes an action under
paragraph (1) that requires the payment of indemnification,
the Administrator shall report to the Committee on Agriculture
of the House of Representatives, the Committee on Agriculture,
Nutrition, and Forestry of the Senate, and the Committees on
Appropriations of the House of Representatives and the Senate
on—
(A) the action taken that requires the payment of
indemnification;
(B) the reasons for taking the action;
(C) the estimated cost of the payment; and
(D) a request for the appropriation of funds for the
payment.
-------
79 FIFRA Sec. 15
(4) APPROPRIATION.—The Administrator may not make a
payment of indemnification under paragraph (1) unless a spe-
cific line item appropriation of funds has been made in advance
for the payment.
(b) INDEMNIFICATION OF END USERS, DEALERS, AND DISTRIBU-
TORS.—
(1) END USERS.—If—
(A) the Administrator notifies a registrant under sec-
tion 6(c)(l) that the Administrator intends to suspend a
registration or that an emergency order of suspension of a
registration under section 6(c)(3) has been issued;
(B) the registration in question is suspended under
section 6(c), and thereafter is canceled under section 6(b),
6(d), or 6(f); and
(C) any person who, immediately before the notice to
the registrant under subparagraph (A), owned any quan-
tity of the pesticide for purposes of applying or using the
pesticide as an end user, rather than for purposes of dis-
tributing or selling it or further processing it for distribu-
tion or sale, suffered a loss by reason of the suspension or
cancellation of the pesticide;
the person shall be entitled to an indemnity payment under
this subsection for such quantity of the pesticide.
(2) DEALERS AND DISTRIBUTORS.—
(A) Any registrant, wholesaler, dealer, or other dis-
tributor (hereinafter in this paragraph referred to as a
"seller") of a registered pesticide who distributes or sells
the pesticide directly to any person not described as an
end user in paragraph (1)(C) shall, with respect to any
quantity of the pesticide that such person cannot use or re-
sell as a result of the suspension or cancellation of the pes-
ticide, reimburse such person for the cost of first acquiring
the pesticide from the seller (other than the cost of trans-
portation, if any), unless the seller provided to the person
at the time of distribution or sale a notice, in writing, that
the pesticide is not subject to reimbursement by the seller.
(B) If—
(i) the Administrator notifies a registrant under
section 6(c)(l) that the Administrator intends to sus-
pend a registration or that an emergency order of sus-
pension of a registration under section 6(c)(3) has been
issued;
(ii) the registration in question is suspended
under section 6(c), and thereafter is canceled under
section 6(b), 6(d), or 6(f);
(iii) any person who, immediately before the notice
to the registrant under clause (i)—
(I) had not been notified in writing by the
seller, as provided under subparagraph (A), that
any quantity of the pesticide owned by such per-
son is not subject to reimbursement by the seller
in the event of suspension or cancellation of the
pesticide; and
-------
Sec. 15 FIFRA 80
(II) owned any quantity of the pesticide for
purposes of—
(aa) distributing or selling it; or
(bb) further processing it for distribution
or sale directly to an end user;
suffered a loss by reason of the suspension or cancella-
tion of the pesticide; and
(iv) the Administrator determines on the basis of
a claim of loss submitted to the Administrator by the
person, that the seller—
(I) did not provide the notice specified in sub-
paragraph (A) to such person; and
(II) is and will continue to be unable to pro-
vide reimbursement to such person, as provided
under subparagraph (A), for the loss referred to in
clause (iii), as a result of the insolvency or bank-
ruptcy of the seller and the seller's resulting in-
ability to provide such reimbursement;
the person shall be entitled to an indemnity payment
under this subsection for such quantity of the pesticide.
(C) If an indemnity payment is made by the United
States under this paragraph, the United States shall be
subrogated to any right that would otherwise be held
under this paragraph by a seller who is unable to make a
reimbursement in accordance with this paragraph with re-
gard to reimbursements that otherwise would have been
made by the seller.
(3) SOURCE.—Any payment required to be made under
paragraph (1) or (2) shall be made from the appropriation pro-
vided under section 1304 of title 31, United States Code.
(4) ADMINISTRATIVE SETTLEMENT.—An administrative set-
tlement of a claim for such indemnity may be made in accord-
ance with the third paragraph of section 2414 of title 28, Unit-
ed States Code, and shall be regarded as if it were made under
that section for purposes of section 1304 of title 31, United
States Code.
(c) AMOUNT OF PAYMENT.—
(1) IN GENERAL.—The amount of an indemnity payment
under subsection (a) or (b) to any person shall be determined
on the basis of the cost of the pesticide owned by the person
(other than the cost of transportation, if any) immediately be-
fore the issuance of the notice to the registrant referred to in
subsection (a)(l)(A), (bXD(A), or (b)(2)(B)(i), except that in no
event shall an indemnity payment to any person exceed the
fair market value of the pesticide owned by the person imme-
diately before the issuance of the notice.
(2) SPECIAL RULE.—Notwithstanding any other provision of
this Act, the Administrator may provide a reasonable time for
use or other disposal of the pesticide. In determining the quan-
tity of any pesticide for which indemnity shall be paid under
this section, proper adjustment shall be made for any pesticide
used or otherwise disposed of by the owner.
-------
81 FIFRA Sec. 17
SEC. 16. [136n] ADMINISTRATIVE PROCEDURE; JUDICIAL REVIEW.
(a) DISTRICT COURT REVIEW.—Except as otherwise provided in
this Act, the refusal of the Administrator to cancel or suspend a
registration or to change a classification not following a hearing
and other final actions of the Administrator not committed to the
discretion of the Administrator by law are judicially reviewable by
the district courts of the United States.
(b) REVIEW BY COURT OF APPEALS.—In the case of actual con-
troversy as to the validity of any order issued by the Administrator
following a public hearing, any person who will be adversely af-
fected by such order and who had been a party to the proceedings
may obtain judicial review by filing in the United States court of
appeals for the circuit wherein such person resides or has a place
of business, within 60 days after the entry of such order, a petition
praying that the order be set aside in whole or in part. A copy of
the petition shall be forthwith transmitted by the clerk of the court
to the Administrator or any officer designated by the Administrator
for that purpose, and thereupon the Administrator shall file in the
court the record of the proceedings on which the Administrator
based the Administrator's order, as provided in section 2112 of title
28, United States Code. Upon the filing of such petition the court
shall have exclusive jurisdiction to affirm or set aside the order
complained of in whole or in part. The court shall consider all evi-
dence of record. The order of the Administrator shall be sustained
if it is supported by substantial evidence when considered on the
record as a whole. The judgment of the court affirming or setting
aside, in whole or in part, any order under this section shall be
final, subject to review by the Supreme Court of the United States
upon certiorari or certification as provided in section 1254 of title
28 of the United States Code. The commencement of proceedings
under this section shall not, unless specifically ordered by the court
to the contrary, operate as a stay of an order.
(c) JURISDICTION OF DISTRICT COURTS.—The district courts of
the United States are vested with jurisdiction specifically to en-
force, and to prevent and restrain violations of, this Act.
(d) NOTICE OF JUDGMENTS.—The Administrator shall, by publi-
cation in such manner as the Administrator may prescribe, give no-
tice of all judgments entered in actions instituted under the author-
ity of this Act.
SEC. 17. [136o] IMPORTS AND EXPORTS.
(a) PESTICIDES AND DEVICES INTENDED FOR EXPORT.—Notwith-
standing any other provision this Act, no pesticide or device or ac-
tive ingredient used in producing a pesticide intended solely for ex-
port to any foreign country shall be deemed in violation of this
Act—
(1) when prepared or packed according to the specifications
or directions of the foreign purchaser, except that producers of
such pesticides and devices and active ingredients used in pro-
ducing pesticides shall be subject to sections 2(p), 2(q) (1) (A),
(C), (D), (E), (G), and (H), 2(q) (2) (A), (B), (C) (i) and (iii), and
(D), 7, and 8 of this Act; and
(2) in the case of any pesticide other than a pesticide reg-
istered under section 3 or sold under section 6(a) (1) of this
Act, if, prior to export, the foreign purchaser has signed a
-------
Sec. 18 FIFRA 82
statement acknowledging that the purchaser understands that
such pesticide is not registered for use in the United States
and cannot be sold in the United States under this Act.
A copy of that statement shall be transmitted to an appropriate of-
ficial of the government of the importing country.
(b) CANCELLATION NOTICES FURNISHED TO FOREIGN GOVERN-
MENTS.—Whenever a registration, or a cancellation or suspension
of the registration of a pesticide becomes effective, or ceases to be
effective, the Administrator shall transmit through the State De-
partment notification thereof to the governments of other countries
and to appropriate international agencies. Such notification shall,
upon request, include all information related to the cancellation or
suspension of the registration of the pesticide and information con-
cerning other pesticides that are registered under section 3 of this
Act and that could be used in lieu of such pesticide.
(c) IMPORTATION OF PESTICIDES AND DEVICES.—The Secretary
of the Treasury shall notify the Administrator of the arrival of pes-
ticides and devices and shall deliver to the Administrator, upon the
Administrator's request, samples of pesticides or devices which are
being imported into the United States, giving notice to the owner
or consignee, who may appear before the Administrator and have
the right to introduce testimony. If it appears from the examination
of a sample that it is adulterated, or misbranded or otherwise vio-
lates the provisions set forth in this Act, or is otherwise injurious
to health or the environment, the pesticide or device may be re-
fused admission, and the Secretary of the Treasury shall refuse de-
livery to the consignee and shall cause the destruction of any pes-
ticide or device refused delivery which shall not be exported by the
consignee within 90 days from the date of notice of such refusal
under such regulations as the Secretary of the Treasury may pre-
scribe. The Secretary of the Treasury may deliver to the consignee
such pesticide or device pending examination and decision in the
matter on execution of bond for the amount of the full invoice value
of such pesticide or device, together with the duty thereon, and on
refusal to return such pesticide or device for any cause to the cus-
tody of the Secretary of the Treasury, when demanded, for the pur-
pose of excluding them from the country, or for any other purpose,
said consignee shall forfeit the full amount of said bond. All
charges for storage, cartage, and labor on pesticides or devices
which are refused admission or delivery shall be paid by the owner
or consignee, and in default of such payment shall constitute a lien
against any future importation made by such owner or consignee.
(d) COOPERATION IN INTERNATIONAL EFFORTS.—The Adminis-
trator shall, in cooperation with the Department of State and any
other appropriate Federal agency, participate and cooperate in any
international efforts to develop improved pesticide research and
regulations.
(e) REGULATIONS.—The Secretary of the Treasury, in consulta-
tion with the Administrator, shall prescribe regulations for the en-
forcement of subsection (c) of this section.
SEC. 18. [136p] EXEMPTION OF FEDERAL AND STATE AGENCD3S.
The Administrator may, at the Administrator's discretion, ex-
empt any Federal or State agency from any provision of this Act
-------
83 FIFRA Sec. 19
if the Administrator determines that emergency conditions exist
which require such exemption. The Administrator, in determining
whether or not such emergency conditions exist, shall consult with
the Secretary of Agriculture and the Governor of any State con-
cerned if they request such determination.
SEC. 19. [136q] STORAGE, DISPOSAL, TRANSPORTATION, AND RECALL.
(a) STORAGE, DISPOSAL, AND TRANSPORTATION.—
(1) DATA REQUIREMENTS AND REGISTRATION OF PES-
TICIDES.—The Administrator may require under section 3 or 6
that—
(A) the registrant or applicant for registration of a pes-
ticide submit or cite data or information regarding meth-
ods for the safe storage and disposal of excess quantities
of the pesticide to support the registration or continued
registration of a pesticide;
(B) the labeling of a pesticide contain requirements
and procedures for the transportation, storage, and dis-
posal of the pesticide, any container of the pesticide, any
rinsate containing the pesticide, or any other material
used to contain or collect excess or spilled quantities of the
pesticide; and
(C) the registrant of a pesticide provide evidence of
sufficient financial and other resources to carry out a re-
call plan under subsection (b), and provide for the disposi-
tion of the pesticide, in the event of suspension and can-
cellation of the pesticide.
(2) PESTICIDES.—The Administrator may by regulation, or
as part of an order issued under section 6 or an amendment
to such an order—
(A) issue requirements and procedures to be followed
by any person who stores or transports a pesticide the reg-
istration of which has been suspended or canceled;
(B) issue requirements and procedures to be followed
by any person who disposes of stocks of a pesticide the reg-
istration of which has been suspended; and
(C) issue requirements and procedures for the disposal
of any pesticide the registration of which has been can-
celed.
(3) CONTAINERS, RINSATES, AND OTHER MATERIALS.—The
Administrator may by regulation, or as part of an order issued
under section 6 or an amendment to such an order—
(A) issue requirements and procedures to be followed
by any person who stores or transports any container of a
pesticide the registration of which has been suspended or
canceled, any rinsate containing the pesticide, or any other
material used to contain or collect excess or spilled quan-
tities of the pesticide;
(B) issue requirements and procedures to be followed
by any person who disposes of stocks of any container of
a pesticide the registration of which has been suspended,
any rinsate containing the pesticide, or any other material
used to contain or collect excess or spilled quantities of the
pesticide; and
-------
Sec. 19 FIFRA 84
(C) issue requirements and procedures for the disposal
of any container of a pesticide the registration of which
has been canceled, any rinsate containing the pesticide, or
any other material used to contain or collect excess or
spilled quantities of the pesticide.
(b) RECALLS.—
(1) IN GENERAL.—If the registration of a pesticide has been
suspended and canceled under section 6, and if the Adminis-
trator finds that recall of the pesticide is necessary to protect
health or the environment, the Administrator shall order a re-
call of the pesticide in accordance with this subsection.
(2) VOLUNTARY RECALL.—If, after determining under para-
graph (1) that a recall is necessary, the Administrator finds
that voluntary recall by the registrant and others in the chain
of distribution may be as safe and effective as a mandatory re-
call, the Administrator shall request the registrant of the pes-
ticide to submit, within 60 days of the request, a plan for the
voluntary recall of the pesticide. If such a plan is requested
and submitted, the Administrator shall approve the plan and
order the registrant to conduct the recall in accordance with
the plan unless the Administrator determines, after an infor-
mal hearing, that the plan is inadequate to protect health or
the environment.
(3) MANDATORY RECALL.—If, after determining under para-
graph (1) that a recall is necessary, the Administrator does not
request the submission of a plan under paragraph (2) or finds
such a plan to be inadequate, the Administrator shall issue a
regulation that prescribes a plan for the recall of the pesticide.
A regulation issued under this paragraph may apply to any
person who is or was a registrant, distributor, or seller of the
pesticide, or any successor in interest to such a person.
(4) RECALL PROCEDURE.—A regulation issued under this
subsection may require any person that is subject to the regu-
lation to—
(A) arrange to make available one or more storage fa-
cilities to receive and store the pesticide to which the re-
call program applies, and inform the Administrator of the
location of each such facility;
(B) accept and store at such a facility those existing
stocks of such pesticide that are tendered by any other
person who obtained the pesticide directly or indirectly
from the person that is subject to such regulation;
(C) on the request of a person making such a tender,
provide for proper transportation of the pesticide to a stor-
age facility; and
(D) take such reasonable steps as the regulation may
prescribe to inform persons who may be holders of the pes-
ticide of the terms of the recall regulation and how those
persons may tender the pesticide and arrange for transpor-
tation of the pesticide to a storage facility.
(5) CONTENTS OF RECALL PLAN.—A recall plan established
under this subsection shall include—
(A) the level in the distribution chain to which the re-
call is to extend, and a schedule for recall; and
-------
85 FIFRA Sec. 19
(B) the means to be used to verify the effectiveness of
the recall.
(6) REQUIREMENTS OR PROCEDURES.—No requirement or
procedure imposed in accordance with paragraph (2) of sub-
section (a) may require the recall of existing stocks of the pes-
ticide except as provided by this subsection.
(c) STORAGE COSTS.—
(1) SUBMISSION OF PLAN.—A registrant who wishes to be-
come eligible for reimbursement of storage costs incurred as a
result of a recall prescribed under subsection (b) for a pesticide
whose registration has been suspended and canceled shall, as
soon as practicable after the suspension of the registration of
the pesticide, submit to the Administrator a plan for the stor-
age and disposal of the pesticide that meets criteria established
by the Administrator by regulation.
(2) REIMBURSEMENT.—Within a reasonable period of time
after such storage costs are incurred and paid by the reg-
istrant, the Administrator shall reimburse the registrant, on
request, for—
(A) none of the costs incurred by the registrant before
the date of submission of the plan referred to in paragraph
(1) to the Administrator;
(B) 100 percent of the costs incurred by the registrant
after the date of submission of the plan to the Adminis-
trator or the date of cancellation of the registration of the
pesticide, whichever is later, but before the approval of the
plan by the Administrator;
(C) 50 percent of the costs incurred by the registrant
during the 1-year period beginning on the date of the ap-
proval of the plan by the Administrator or the date of can-
cellation of the registration of the pesticide, whichever is
later;
(D) none of the costs incurred by the registrant during
the 3-year period beginning on the 366th day following ap-
proval of the plan by the Administrator or the date of can-
cellation of the registration of the pesticide, whichever is
later; and
(E) 25 percent of the costs incurred by the registrant
during the period beginning on the first day of the 5th
year following the date of the approval of the plan by the
Administrator or the date of cancellation of the registra-
tion of the pesticide, whichever is later, and ending on the
date that a disposal permit for the pesticide is issued by
a State or an alternative plan for disposal of the pesticide
in accordance with applicable law has been developed.
(d) ADMINISTRATION OF STORAGE, DISPOSAL, TRANSPORTATION,
AND RECALL PROGRAMS.—
(1) VOLUNTARY AGREEMENTS.—Nothing in this section
shall be construed as preventing or making unlawful any
agreement between a seller and a buyer of any pesticide or
other substance regarding the ultimate allocation of the costs
of storage, transportation, or disposal of a pesticide.
-------
Sec. 19 FIFRA 86
(2) RULE AND REGULATION REVIEW.—Section 25(a)(4) shall
not apply to any regulation issued under subsection (a)(2) or
(b).
(3) LIMITATIONS.—No registrant shall be responsible under
this section for a pesticide the registration of which is held by
another person. No distributor or seller shall be responsible
under this section for a pesticide that the distributor or seller
did not hold or sell.
(4) SEIZURE AND PENALTIES.—If the Administrator finds
that a person who is subject to a regulation or order under
subsection (a)(2) or (b) has failed substantially to comply with
that regulation or order, the Administrator may take action
under section 13 or 14 or obtain injunctive relief under section
16(c) against such person or any successor in interest of any
such person.
(e) CONTAINER DESIGN.—
(1) PROCEDURES.—
(A) Not later than 3 years after the effective date of
this subsection, the Administrator shall, in consultation
with the heads of other interested Federal agencies, pro-
mulgate regulations for the design of pesticide containers
that will promote the safe storage and disposal of pes-
ticides.
(B) The regulations shall ensure, to the fullest extent
practicable, that the containers—
(i) accommodate procedures used for the removal
of pesticides from the containers and the rinsing of the
containers;
(ii) facilitate the safe use of the containers, includ-
ing elimination of splash and leakage of pesticides
from the containers;
(iii) facilitate the safe disposal of the containers;
and
(iv) facilitate the safe refill and reuse of the
containers.
(2) COMPLIANCE.—The Administrator shall require compli-
ance with the regulations referred to in paragraph (1) not later
than 5 years after the effective date of this subsection.
(f) PESTICIDE RESIDUE REMOVAL.—
(1) PROCEDURES.—
(A) Not later than 3 years after the effective date of
this subsection, the Administrator shall, in consultation
with the heads of other interested Federal agencies, pro-
mulgate regulations prescribing procedures and standards
for the removal of pesticides from containers prior to dis-
posal.
(B) The regulations may—
(i) specify, for each major type of pesticide con-
tainer, procedures and standards providing for, at a
minimum, triple rinsing or the equivalent degree of
pesticide removal;
(ii) specify procedures that can be implemented
promptly and easily in various circumstances and con-
ditions;
-------
87 FIFRA Sec. 19
(iii) provide for reuse, whenever practicable, or
disposal of rinse water and residue; and
(iv) be coordinated with requirements for the rins-
ing of containers imposed under the Solid Waste Dis-
posal Act (42 U.S.C. 6901 et seq.).
(C) The Administrator may, at the discretion of the
Administrator, exempt products intended solely for house-
hold use from the requirements of this subsection.
(2) COMPLIANCE.—Effective beginning 5 years after the ef-
fective date of this subsection, a State may not exercise pri-
mary enforcement responsibility under section 26, or certify an
applicator under section 11, unless the Administrator deter-
mines that the State is carrying out an adequate program to
ensure compliance with this subsection.
(3) SOLID WASTE DISPOSAL ACT.—Nothing in this subsection
shall affect the authorities or requirements concerning pes-
ticide containers under the Solid Waste Disposal Act (42 U.S.C.
6901).
(g) PESTICIDE CONTAINER STUDY.—
(1) STUDY.—
(A) The Administrator shall conduct a study of options
to encourage or require—
(i) the return, refill, and reuse of pesticide con-
tainers;
(ii) the development and use of pesticide formula-
tions that facilitate the removal of pesticide residues
from containers; and
(iii) the use of bulk storage facilities to reduce the
number of pesticide containers requiring disposal.
(B) In conducting the study, the Administrator shall—
(i) consult with the heads of other interested Fed-
eral agencies, State agencies, industry groups, and en-
vironmental organizations; and
(ii) assess the feasibility, costs, and environmental
benefits of encouraging or requiring various measures
or actions.
(2) REPORT.—Not later than 2 years after the effective date
of this subsection, the Administrator shall submit to Congress
a report describing the results of the study required under
paragraph (1).
(h) RELATIONSHIP TO SOLID WASTE DISPOSAL ACT.—
(1) IN GENERAL.—Nothing in this section shall diminish
the authorities or requirements of the Solid Waste Disposal Act
(42 U.S.C. 6901 et seq.).
(2) ANTIMICROBIAL PRODUCTS.—A household, industrial, or
institutional antimicrobial product that is not subject to regu-
lation under the Solid Waste Disposal Act (42 U.S.C. 6901 et
seq.) shall not be subject to the provisions of subsections (a),
(e), and (f), unless the Administrator determines that such
product must be subject to such provisions to prevent an un-
reasonable adverse effect on the environment.
-------
Sec. 20 FIFRA 88
SEC. 20. [136r] RESEARCH AND MONITORING.
(a) RESEARCH.—The Administrator shall undertake research,
including research by grant or contract with other Federal agen-
cies, universities, or others as may be necessary to carry out the
purposes of this Act, and the Administrator shall conduct research
into integrated pest management in coordination with the Sec-
retary of Agriculture. The Administrator shall also take care to en-
sure that such research does not duplicate research being under-
taken by any other Federal agency.
(b) NATIONAL MONITORING PLAN.—The Administrator shall for-
mulate and periodically revise, in cooperation with other Federal,
State, or local agencies, a national plan for monitoring pesticides.
(c) MONITORING.—The Administrator shall undertake such
monitoring activities, including, but not limited to monitoring in
air, soil, water, man, plants, and animals, as may be necessary for
the implementation of this Act and of the national pesticide mon-
itoring plan. The Administrator shall establish procedures for the
monitoring of man and animals and their environment for inciden-
tal pesticide exposure, including, but not limited to, the quantifica-
tion of incidental human and environmental pesticide pollution and
the secular trends thereof, and identification of the sources of con-
tamination and their relationship to human and environmental ef-
fects. Such activities shall be carried out in cooperation with other
Federal, State, and local agencies.
SEC. 21. [136s] SOLICITATION OF COMMENTS; NOTICE OF PUBLIC
HEARINGS.
(a) SECRETARY OF AGRICULTURE.—The Administrator, before
publishing regulations under this Act, shall solicit the views of the
Secretary of Agriculture in accordance with the procedure described
in section 25(a).
(b) SECRETARY OF HEALTH AND HUMAN SERVICES.—The Admin-
istrator, before publishing regulations under this Act for any public
health pesticide, shall solicit the views of the Secretary of Health
and Human Services in the same manner as the views of the Sec-
retary of Agriculture are solicited under section 25(a)(2).
(c) VIEWS.—In addition to any other authority relating to pub-
lic hearings and solicitation of views, in connection with the sus-
pension or cancellation of a pesticide registration or any other ac-
tions authorized under this Act, the Administrator may, at the Ad-
ministrator's discretion, solicit the views of all interested persons,
either orally or in writing, and seek such advice from scientists,
farmers, farm organizations, and other qualified persons as the Ad-
ministrator deems proper.
(d) NOTICE.—In connection with all public hearings under this
Act the Administrator shall publish timely notice of such hearings
in the Federal Register.
SEC. 22. [136t] DELEGATION AND COOPERATION.
(a) DELEGATION.—All authority vested in the Administrator by
virtue of the provisions of this Act may with like force and effect
be executed by such employees of the Environmental Protection
Agency as the Administrator may designate for the purpose.
(b) COOPERATION.—The Administrator shall cooperate with the
Department of Agriculture, any other Federal agency, and any ap-
-------
89 FIFRA Sec. 24
propriate agency of any State or any political subdivision thereof,
in carrying out the provisions of this Act, and in securing uniform-
ity of regulations.
SEC. 23. [136u] STATE COOPERATION, AID, AND TRAINING.
(a) COOPERATIVE AGREEMENTS.—The Administrator may enter
into cooperative agreements with States and Indian tribes—
(1) to delegate to any State or Indian tribe the authority
to cooperate in the enforcement of this Act through the use of
its personnel or facilities, to train personnel of the State or In-
dian tribe to cooperate in the enforcement of this Act, and to
assist States and Indian tribes in implementing cooperative en-
forcement programs through grants-in-aid; and
(2) to assist States in developing and administering State
programs, and Indian tribes that enter into cooperative agree-
ments, to train and certify applicators consistent with the
standards the Administrator prescribes.
Effective with the fiscal year beginning October 1, 1978, there are
authorized to be appropriated annually such funds as may be nec-
essary for the Administrator to provide through cooperative agree-
ments an amount equal to 50 percent of the anticipated cost to
each State or Indian tribe, as agreed to under such cooperative
agreements, of conducting training and certification programs dur-
ing such fiscal year. If funds sufficient to pay 50 percent of the
costs for any year are not appropriated, the share of each State and
Indian tribe shall be reduced in a like proportion in allocating
available funds.
(b) CONTRACTS FOR TRAINING.—In addition, the Administrator
may enter into contracts with Federal, State, or Indian tribal agen-
cies for the purpose of encouraging the training of certified applica-
tors.
(c) INFORMATION AND EDUCATION.—The Administrator shall, in
cooperation with the Secretary of Agriculture, use the services of
the cooperative State extension services to inform and educate pes-
ticide users about accepted uses and other regulations made under
this Act.
SEC. 24. [136v] AUTHORITY OF STATES.
(a) IN GENERAL.—A State may regulate the sale or use of any
federally registered pesticide or device in the State, but only if and
to the extent the regulation does not permit any sale or use prohib-
ited by this Act.
(b) UNIFORMITY.—Such State shall not impose or continue in
effect any requirements for labeling or packaging in addition to or
different from those required under this Act.
(c) ADDITIONAL USES.—
(1) A State may provide registration for additional uses of
federally registered pesticides formulated for distribution and
use within that State to meet special local needs in accord with
the purposes of this Act and if registration for such use has not
previously been denied, disapproved, or canceled by the Admin-
istrator. Such registration shall be deemed registration under
section 3 for all purposes of this Act, but shall authorize dis-
tribution and use only within such State.
-------
Sec. 25 FIFRA 90
(2) A registration issued by a State under this subsection
shall not be effective for more than ninety days if disapproved
by the Administrator within that period. Prior to disapproval,
the Administrator shall, except as provided in paragraph (3) of
this subsection, advise the State of the Administrator's inten-
tion to disapprove and the reasons therefor, and provide the
State time to respond. The Administrator shall not prohibit or
disapprove a registration issued by a State under this sub-
section (A) on the basis of lack of essentiality of a pesticide or
(B) except as provided in paragraph (3) of this subsection, if its
composition and use patterns are similar to those of a federally
registered pesticide.
(3) In no instance may a State issue a registration for a
food or feed use unless there exists a tolerance or exemption
under the Federal Food, Drug, and Cosmetic Act that permits
the residues of the pesticide on the food or feed. If the Admin-
istrator determines that a registration issued by a State is in-
consistent with the Federal Food, Drug, and Cosmetic Act, or
the use of, a pesticide under a registration issued by a State
constitutes an imminent hazard, the Administrator may imme-
diately disapprove the registration.
(4) If the Administrator finds, in accordance with stand-
ards set forth in regulations issued under section 25 of this
Act, that a State is not capable of exercising adequate controls
to assure that State registration under this section will be in
accord with the purposes of this Act or has failed to exercise
adequate controls, the Administrator may suspend the author-
ity of the State to register pesticides until such time as the Ad-
ministrator is satisfied that the State can and will exercise
adequate controls. Prior to any such suspension, the Adminis-
trator shall advise the State of the Administrator's intention to
suspend and the reasons therefor and provide the State time
to respond.
SEC. 25. [136w] AUTHORITY OF ADMINISTRATOR.
(a) IN GENERAL.—
(1) REGULATIONS.—The Administrator is authorized in ac-
cordance with the procedure described in paragraph (2), to pre-
scribe regulations to carry out the provisions of this Act. Such
regulations shall take into account the difference in concept
and usage between various classes of pesticides, including pub-
lic health pesticides, and differences in environmental risk and
the appropriate data for evaluating such risk between agricul-
tural, nonagricultural, and public health pesticides.
(2) PROCEDURE.—
(A) PROPOSED REGULATIONS.—At least 60 days prior to
signing any proposed regulation for publication in the Fed-
eral Register, the Administrator shall provide the Sec-
retary of Agriculture with a copy of such regulation. If the
Secretary comments in writing to the Administrator re-
garding any such regulation within 30 days after receiving
it, the Administrator shall publish in the Federal Register
(with the proposed regulation) the comments of the Sec-
retary and the response of the Administrator with regard
-------
91 FIFRA Sec. 25
to the Secretary's comments. If the Secretary does not
comment in writing to the Administrator regarding the
regulation within 30 days after receiving it, the Adminis-
trator may sign such regulation for publication in the Fed-
eral Register any time after such 30-day period notwith-
standing the foregoing 60-day time requirement.
(B) FINAL REGULATIONS.—At least 30 days prior to
signing any regulation in final form for publication in the
Federal Register, the Administrator shall provide the Sec-
retary of Agriculture with a copy of such regulation. If the
Secretary comments in writing to the Administrator re-
garding any such final regulation within 15 days after re-
ceiving it, the Administrator shall publish in the Federal
Register (with the final regulation) the comments of the
Secretary, if requested by the Secretary, and the response
of the Administrator concerning the Secretary's comments.
If the Secretary does not comment in writing to the Ad-
ministrator regarding the regulation within 15 days after
receiving it, the Administrator may sign such regulation
for publication in the Federal Register at any time after
such 15-day period notwithstanding the foregoing 30-day
time requirement. In taking any final action under this
subsection, the Administrator shall include among those
factors to be taken into account the effect of the regulation
on production and prices of agricultural commodities, re-
tail food prices, and otherwise on the agricultural economy,
and the Administrator shall publish in the Federal Reg-
ister an analysis of such effect.
(C) TIME REQUIREMENTS.—The time requirements im-
posed by subparagraphs (A) and (B) may be waived or
modified to the extent agreed upon by the Administrator
and the Secretary.
(D) PUBLICATION IN THE FEDERAL REGISTER.—The Ad-
ministrator shall, simultaneously with any notification to
the Secretary of Agriculture under this paragraph prior to
the issuance of any proposed or final regulation, publish
such notification in the Federal Register.
(3) CONGRESSIONAL COMMITTEES.—At such time as the Ad-
ministrator is required under paragraph (2) of this subsection
to provide the Secretary of Agriculture with a copy of proposed
regulations and a copy of the final form of regulations, the Ad-
ministrator shall also furnish a copy of such regulations to the
Committee on Agriculture of the House of Representatives and
the Committee on Agriculture, Nutrition, and Forestry of the
Senate.
(4) CONGRESSIONAL REVIEW OF REGULATIONS.—Simulta-
neously with the promulgation of any rule or regulation under
this Act, the Administrator shall transmit a copy thereof to the
Secretary of the Senate and the Clerk of the House of Rep-
resentatives. The rule or regulation shall not become effective
until the passage of 60 calendar days after the rule or regula-
tion is so transmitted.
(b) EXEMPTION OF PESTICIDES.—The Administrator may ex-
empt from the requirements of this Act by regulation any pesticide
-------
Sec. 25 FIFRA 92
which the Administrator determines either (1) to be adequately
regulated by another Federal agency, or (2) to be of a character
which is unnecessary to be subject to this Act in order to carry out
the purposes of this Act.
(c) OTHER AUTHORITY.—The Administrator, after notice and
opportunity for hearing, is authorized—
(1) to declare a pest any form of plant or animal life (other
than man and other than bacteria, virus, and other micro-orga-
nisms on or in living man or other living animals) which is in-
jurious to health or the environment;
(2) to determine any pesticide which contains any sub-
stance or substances in quantities highly toxic to man;
(3) to establish standards (which shall be consistent with
those established under the authority of the Poison Prevention
Packaging Act (Public Law 91-601)) with respect to the pack-
age, container, or wrapping in which a pesticide or device is
enclosed for use or consumption, in order to protect children
and adults from serious injury or illness resulting from acci-
dental ingestion or contact with pesticides or devices regulated
by this Act as well as to accomplish the other purposes of this
Act;
(4) to specify those classes of devices which shall be subject
to any provision of paragraph 2(q)(l) or section 7 of this Act
upon the Administrator's determination that application of
such provision is necessary to effectuate the purposes of this
Act;
(5) to prescribe regulations requiring any pesticide to be
colored or discolored if the Administrator determines that such
requirement is feasible and is necessary for the protection of
health and the environment; and
(6) to determine and establish suitable names to be used
in the ingredient statement.
(d) SCIENTIFIC ADVISORY PANEL.—
(1) IN GENERAL.—The Administrator shall submit to an ad-
visory panel for comment as to the impact on health and the
environment of the action proposed in notices of intent issued
under section 6(b) and of the proposed and final form of regula-
tions issued under section 25(a) within the same time periods
as provided for the comments of the Secretary of Agriculture
under such sections. The time requirements for notices of in-
tent and proposed and final forms of regulation may not be
modified or waived unless in addition to meeting the require-
ments of section 6(b) or 25(a), as applicable, the advisory panel
has failed to comment on the proposed action within the pre-
scribed time period or has agreed to the modification or waiver.
The Administrator shall also solicit from the advisory panel
comments, evaluations, and recommendations for operating
guidelines to improve the effectiveness and quality of scientific
analyses made by personnel of the Environmental Protection
Agency that lead to decisions by the Administrator in carrying
out the provisions of this Act. The comments, evaluations, and
recommendations of the advisory panel submitted under this
subsection and the response of the Administrator shall be pub-
lished in the Federal Register in the same manner as provided
-------
93 FIFRA Sec. 25
for publication of the comments of the Secretary of Agriculture
under such sections. The chairman of the advisory panel, after
consultation with the Administrator, may create temporary
subpanels on specific projects to assist the full advisory panel
in expediting and preparing its evaluations, comments, and
recommendations. The subpanels may be composed of sci-
entists other than members of the advisory panel, as deemed
necessary for the purpose of evaluating scientific studies relied
upon by the Administrator with respect to proposed action.
Such additional scientists shall be selected by the advisory
panel. The panel referred to in this subsection shall consist of
7 members appointed by the Administrator from a list of 12
nominees, 6 nominated by the National Institutes of Health
and 6 by the National Science Foundation, utilizing a system
of staggered terms of appointment. Members of the panel shall
be selected on the basis of their professional qualifications to
assess the effects of the impact of pesticides on health and the
environment. To the extent feasible to insure multidisciplinary
representation, the panel membership shall include representa-
tion from the disciplines of toxicology, pathology, environ-
mental biology, and related sciences. If a vacancy occurs on the
panel due to expiration of a term, resignation, or any other
reason, each replacement shall be selected by the Adminis-
trator from a group of 4 nominees, 2 submitted by each of the
nominating entities named in this subsection. The Adminis-
trator may extend the term of a panel member until the new
member is appointed to fill the vacancy. If a vacancy occurs
due to resignation, or reason other than expiration of a term,
the Administrator shall appoint a member to serve during the
unexpired term utilizing the nomination process set forth in
this subsection. Should the list of nominees provided under
this subsection be unsatisfactory, the Administrator may re-
quest an additional set of nominees from the nominating enti-
ties. The Administrator may require such information from the
nominees to the advisory panel as the Administrator deems
necessary, and the Administrator shall publish in the Federal
Register the name, address, and professional affiliations of
each nominee. Each member of the panel shall receive per
diem compensation at a rate not in excess of that fixed for GS-
18 of the General Schedule as may be determined by the Ad-
ministrator, except that any such member who holds another
office or position under the Federal Government the compensa-
tion for which exceeds such rate may elect to receive com-
pensation at the rate provided for such other office or position
in lieu of the compensation provided by this subsection. In
order to assure the objectivity of the advisory panel, the Ad-
ministrator shall promulgate regulations regarding conflicts of
interest with respect to the members of the panel. The advi-
sory panel established under this section shall be permanent.
In performing the functions assigned by this Act, the panel
shall consult and coordinate its activities with the Science Ad-
visory Board established under the Environmental Research,
Development, and Demonstration Authorization Act of 1978.
Whenever the Administrator exercises authority under section
-------
Sec. 26 FIFRA 94
6(c) of this Act to immediately suspend the registration of any
pesticide to prevent an imminent hazard, the Administrator
shall promptly submit to the advisory panel for comment, as
to the impact on health and the environment, the action taken
to suspend the registration of such pesticide.
(2) SCIENCE REVIEW BOARD.—There is established a
Science Review Board to consist of 60 scientists who shall be
available to the Scientific Advisory Panel to assist in reviews
conducted by the Panel. Members of the Board shall be se-
lected in the same manner as members of temporary subpanels
created under paragraph (1). Members of the Board shall be
compensated in the same manner as members of the Panel.
(e) PEER REVIEW.—The Administrator shall, by written proce-
dures, provide for peer review with respect to the design, protocols,
and conduct of major scientific studies conducted under this Act by
the Environmental Protection Agency or by any other Federal
agency, any State or political subdivision thereof, or any institution
or individual under grant, contract, or cooperative agreement from
or with the Environmental Protection Agency. In such procedures,
the Administrator shall also provide for peer review, using the ad-
visory panel established under subsection (d) of this section or ap-
propriate experts appointed by the Administrator from a current
list of nominees maintained by such panel, with respect to the re-
sults of any such scientific studies relied upon by the Administrator
with respect to actions the Administrator may take relating to the
change in classification, suspension, or cancellation of a pesticide.
Whenever the Administrator determines that circumstances do not
permit the peer review of the results of any such scientific study
prior to the Administrator's exercising authority under section 6(c)
of this Act to immediately suspend the registration of any pesticide
to prevent an imminent hazard, the Administrator shall promptly
thereafter provide for the conduct of peer review as provided in this
sentence. The evaluations and relevant documentation constituting
the peer review that relate to the proposed scientific studies and
the results of the completed scientific studies shall be included in
the submission for comment forwarded by the Administrator to the
advisory panel as provided in subsection (d). As used in this sub-
section, the term "peer review" shall mean an independent evalua-
tion by scientific experts, either within or outside the Environ-
mental Protection Agency, in the appropriate disciplines.
SEC. 26. [136w-l] STATE PRIMARY ENFORCEMENT RESPONSIBILITY.
(a) IN GENERAL.—For the purposes of this Act, a State shall
have primary enforcement responsibility for pesticide use violations
during any period for which the Administrator determines that
such State—
(1) has adopted adequate pesticide use laws and regula-
tions, except that the Administrator may not require a State
to have pesticide use laws that are more stringent than this
Act;
(2) has adopted and is implementing adequate procedures
for the enforcement of such State laws and regulations; and
-------
95 FIFRA Sec. 26
(3) will keep such records and make such reports showing
compliance with paragraphs (1) and (2) of this subsection as
the Administrator may require by regulation.
(b) SPECIAL RULES.—Notwithstanding the provisions of sub-
section (a) of this section, any State that enters into a cooperative
agreement with the Administrator under section 23 of this Act for
the enforcement of pesticide use restrictions shall have the primary
enforcement responsibility for pesticide use violations. Any State
that has a plan approved by the Administrator in accordance with
the requirements of section 11 of this Act that the Administrator
determines meets the criteria set out in subsection (a) of this sec-
tion shall have the primary enforcement responsibility for pesticide
use violations. The Administrator shall make such determinations
with respect to State plans under section 11 of this Act in effect
on the date of enactment of the Federal Pesticide Act of 1978 not
later than six months after that date.
(c) ADMINISTRATOR.—The Administrator shall have primary en-
forcement responsibility for those States that do not have primary
enforcement responsibility under this Act. Notwithstanding the
provisions of section 2(e)(l) of this Act, during any period when the
Administrator has such enforcement responsibility, section 8(b) of
this Act shall apply to the books and records of commercial applica-
tors and to any applicator who holds or applies pesticides, or uses
dilutions of pesticides, only to provide a service of controlling pests
without delivering any unapplied pesticide to any person so served,
and section 9(a) of this Act shall apply to the establishment or
other place where pesticides or devices are held for application by
such persons with respect to pesticides or devices held for such ap-
plication.
SEC. 27. [136w-2] FAILURE BY THE STATE TO ASSURE ENFORCEMENT
OF STATE PESTICIDE USE REGULATIONS.
(a) REFERRAL.—Upon receipt of any complaint or other infor-
mation alleging or indicating a significant violation of the pesticide
use provisions of this Act, the Administrator shall refer the matter
to the appropriate State officials for their investigation of the mat-
ter consistent with the requirements of this Act. If, within thirty
days, the State has not commenced appropriate enforcement action,
the Administrator may act upon the complaint or information to
the extent authorized under this Act.
(b) NOTICE.—Whenever the Administrator determines that a
State having primary enforcement responsibility for pesticide use
violations is not carrying out (or cannot carry out due to the lack
of adequate legal authority) such responsibility, the Administrator
shall notify the State. Such notice shall specify those aspects of the
administration of the State program that are determined to be in-
adequate. The State shall have ninety days after receipt of the no-
tice to correct any deficiencies. If after that time the Administrator
determines that the State program remains inadequate, the Ad-
ministrator may rescind, in whole or in part, the State's primary
enforcement responsibility for pesticide use violations.
(c) CONSTRUCTION.—Neither section 26 of this Act nor this sec-
tion shall limit the authority of the Administrator to enforce this
Act, where the Administrator determines that emergency condi-
tions exist that require immediate action on the part of the Admin-
-------
Sec. 28 FIFRA 96
istrator and the State authority is unwilling or unable adequately
to respond to the emergency.
SEC. 28. [136w-3] IDENTIFICATION OF PESTS; COOPERATION WITH DE-
PARTMENT OF AGRICULTURE'S PROGRAM.
(a) IN GENERAL.—The Administrator, in coordination with the
Secretary of Agriculture, shall identify those pests that must be
brought under control. The Administrator shall also coordinate and
cooperate with the Secretary of Agriculture's research and imple-
mentation programs to develop and improve the safe use and effec-
tiveness of chemical, biological, and alternative methods to combat
and control pests that reduce the quality and economical produc-
tion and distribution of agricultural products to domestic and for-
eign consumers.
(b) PEST CONTROL AVAILABILITY.—
(1) IN GENERAL.—The Administrator, in cooperation with
the Secretary of Agriculture, shall identify—
(A) available methods of pest control by crop or ani-
mal;
(B) minor pest control problems, both in minor crops
and minor or localized problems in major crops; and
(C) factors limiting the availability of specific pest con-
trol methods, such as resistance to control methods and
regulatory actions limiting the availability of control meth-
ods.
(2) REPORT.—The Secretary of Agriculture shall, not later
than 180 days after the date of enactment of this subsection
and annually thereafter, prepare a report and send the report
to the Administrator. The report shall—
(A) contain the information described in paragraph (1)
and the information required by section 1651 of the Food,
Agriculture, Conservation, and Trade Act of 1990;
(B) identify the crucial pest control needs where a
shortage of control methods is indicated by the information
described in paragraph (1); and
(C) describe in detail research and extension efforts
designed to address the needs identified in subparagraph
(B).
(c) INTEGRATED PEST MANAGEMENT.—The Administrator, in
cooperation with the Secretary of Agriculture, shall develop
approaches to the control of pests based on integrated pest man-
agement that respond to the needs of producers, with a special em-
phasis on minor pests.
(d) PUBLIC HEALTH PESTS.—The Administrator, in coordination
with the Secretary of Agriculture and the Secretary of Health and
Human Services, shall identify pests of significant public health
importance and, in coordination with the Public Health Service, de-
velop and implement programs to improve and facilitate the safe
and necessary use of chemical, biological, and other methods to
combat and control such pests of public health importance.
SEC. 29. [136w-i] ANNUAL REPORT.
The Administrator shall submit an annual report to Congress
before February 16 of each year and the first report shall be due
February 15, 1979. The report shall include the total number of ap-
-------
97 FIFRA Sec. 32
plications for conditional registration under sections 3(c)(7)(B) and
3(c)(7)(C) of this Act that were filed during the immediately preced-
ing fiscal year, and, with respect to those applications approved,
the Administrator shall report the Administrator's findings in each
case, the conditions imposed and any modification of such condi-
tions in each case, and the quantities produced of such pesticides.
SEC. 30. [136w-5] MINIMUM REQUIREMENTS FOR TRAINING OF MAIN-
TENANCE APPLICATORS AND SERVICE TECHNICIANS.
Each State may establish minimum requirements for training
of maintenance applicators and service technicians. Such training
may include instruction in the safe and effective handling and use
of pesticides in accordance with the Environmental Protection
Agency approved labeling, and instruction in integrated pest man-
agement techniques. The authority of the Administrator with re-
spect to minimum requirements for training of maintenance appli-
cators and service technicians shall be limited to ensuring that
each State understands the provisions of this section.
SEC. 31. [136w-6] ENVIRONMENTAL PROTECTION AGENCY MINOR USE
PROGRAM.
(a) The Administrator shall assure coordination of minor use
issues through the establishment of a minor use program within
the Office of Pesticide Programs. Such office shall be responsible
for coordinating the development of minor use programs and poli-
cies and consulting with growers regarding minor use issues and
registrations and amendments which are submitted to the Environ-
mental Protection Agency.
(b) The Office of Pesticide Programs shall prepare a public re-
port concerning the progress made on the registration of minor
uses, including implementation of the exclusive use as an incentive
for registering new minor uses, within 3 years of the passage of the
Food Quality Protection Act of 1996.
SEC. 32. [136w-7] DEPARTMENT OF AGRICULTURE MINOR USE PRO-
GRAM.
(a) IN GENERAL.—The Secretary of Agriculture (hereinafter in
this section referred to as the "Secretary") shall assure the coordi-
nation of the responsibilities of the Department of Agriculture re-
lated to minor uses of pesticides, including—
(1) carrying out the Inter-Regional Project Number 4 (IR-
4) as described in section 2 of Public Law 89-106 (7 U.S.C.
450i(e)) and the national pesticide resistance monitoring pro-
gram established under section 1651 of the Food, Agriculture,
Conservation, and Trade Act of 1990 (7 U.S.C. 5882);
(2) supporting integrated pest management research;
(3) consulting with growers to develop data for minor uses;
and
(4) providing assistance for minor use registrations, toler-
ances, and reregistrations with the Environmental Protection
Agency.
(b)(l) MINOR USE PESTICIDE DATA.—
(A) GRANT AUTHORITY.—The Secretary, in consultation
with the Administrator, shall establish a program to make
grants for the development of data to support minor use pes-
ticide registrations and reregistrations. The amount of any
-------
Sec. 33 FIFRA 98
such grant shall not exceed Vz of the cost of the project for
which the grant is made.
(B) APPLICANTS.—Any person who wants to develop data to
support minor use pesticide registrations and reregistrations
may apply for a grant under subparagraph (A). Priority shall
be given to an applicant for such a grant who does not directly
receive funds from the sale of pesticides registered for minor
uses.
(C) DATA OWNERSHIP.—Any data that is developed under
a grant under subparagraph (A) shall be jointly owned by the
Department of Agriculture and the person who received the
grant. Such a person shall enter into an agreement with the
Secretary under which such person shall share any fee paid to
such person under section 3(c)(l)(F).
(2) MINOR USE PESTICIDE DATA REVOLVING FUND.—
(A) ESTABLISHMENT.—There is established in the Treasury
of the United States a revolving fund to be known as the Minor
Use Pesticide Data Revolving Fund. The Fund shall be avail-
able without fiscal year limitation to carry out the authorized
purposes of this subsection.
(B) CONTENTS OF THE FUND.—There shall be deposited in
the Fund—
(i) such amounts as may be appropriated to support
the purposes of this subsection; and
(ii) fees collected by the Secretary for any data devel-
oped under a grant under paragraph (1)(A).
(C) AUTHORIZATIONS OF APPROPRIATIONS.—There are au-
thorized to be appropriated for each fiscal year to carry out the
purposes of this subsection $10,000,000 to remain available
until expended.
SEC. 33. r 136x1 SEVERABILITY.
If any provision of this Act or the application thereof to any
person or circumstance is held invalid, the invalidity shall not af-
fect other provisions or applications of this Act which can be given
effect without regard to the invalid provision or application, and to
this end the provisions of this Act are severable.
SEC. 34. [136y] AUTHORIZATION FOR APPROPRIATIONS.
There is authorized to be appropriated to carry out this Act
(other than section 23(a))—
(1) $83,000,000 for fiscal year 1989, of which not more
than $13,735,500 shall be available for research under this
Act;
(2) $95,000,000 for fiscal year 1990, of which not more
than $14,343,600 shall be available for research under this
Act; and
(3) $95,000,000 for fiscal year 1991, of which not more
than $14,978,200 shall be available for research under this
Act.
-------
FEDERAL FOOD, DRUG, AND COSMETIC ACT
99
-------
-------
FEDERAL FOOD, DRUG, AND COSMETIC ACT
(References in brackets [ ] are to title 21, United States Code)
CHAPTER I—SHORT TITLE
SECTION 1. This Act may be cited as the Federal Food, Drug,
and Cosmetic Act.
101
-------
CHAPTER II—DEFINITIONS *
SEC. 201. [321] For the purposes of this Act—
(a)(l) The term "State", except as used in the last sentence of
section 702(a), means any State or Territory of the United States,
the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term "Territory" means any Territory or possession of
the United States, including the District of Columbia, and exclud-
ing the Commonwealth of Puerto Rico and the Canal Zone.
(b) The term "interstate commerce" means (1) commerce be-
tween any State or Territory and any place outside thereof, and (2)
commerce within the District of Columbia or within any other Ter-
ritory not organized with a legislative body.
(c) The term "Department" means the Department of Health
and Human Services.
(d) The term "Secretary" means the Secretary of Health and
Human Services.
(e) The term "person" includes individual, partnership, corpora-
tion, and association.
(f) 1The term "food" means (1) articles used for food or drink
for man or other animals, (2) chewing gum, and (3) articles used
for components of any such article.
(g)(l) The term "drug" means (A) articles recognized in the offi-
cial United States Pharmacopeia, official Homeopathic Pharma-
copeia of the United States, or official National Formulary, or any
supplement to any of them; and (B) articles intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in
man or other animals; and (C) articles (other than food) intended
to affect the structure or any function of the body of man or other
animals; and (D) articles intended for use as a component of any
articles specified in clause (A), (B), or (C). A food or dietary supple-
ment for which a claim, subject to sections 403(r)(l)(B) and
403(r)(3) or sections 403(r)(l)(B) and 403(r)(5)(D), is made in ac-
cordance with the requirements of section 403(r) is not a drug sole-
ly because the label or the labeling contains such a claim. A food,
dietary ingredient, or dietary supplement for which a truthful and
not misleading statement is made in accordance with section
1 The following additional definitions applicable to this Act are provided for in other Acts:
Butter. The Act of March 4, 1923 (21 U.S.C. 321a), defines butter as "the food product usually
known as butter, and which is made exclusively from milk or cream, or both, with or without
common salt, and with or without additional coloring matter, and containing not less than 80
per centum by weight of milk fat, all tolerances having been allowed for."
Package. The Act of July 24, 1919 (21 U.S.C. 321b), states "The word 'package' shall include
and shall be construed to include wrapped meats inclosed in papers or other materials as pre-
pared by the manufacturers thereof for sale."
Nonfat Dry Milk, Milk. The Act of July 2, 1956 (21 U.S.C. 321c), defines nonfat dry milk as
"the product resulting from the removal of fat and water from milk, and contains the lactose,
milk proteins, and milk minerals in the same relative proportions as in the fresh milk from
which made. It contains not over 5 per centum by weight of moisture. The fat content is not
over IVz per centum by weight unless otherwise indicated.", and defines milk to mean sweet
milk of cows.
102
-------
103 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 201
403(r)(6) is not a drug under clause (C) solely because the label or
the labeling contains such a statement.
(2) The term "counterfeit drug" means a drug which, or the
container or labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark, imprint, or de-
vice, or any likeness thereof, of a drug manufacturer, processor,
packer, or distributor other than the person or persons who in fact
manufactured, processed, packed, or distributed such drug and
which thereby falsely purports or is represented to be the product
of, or to have been packed or distributed by, such other drug manu-
facturer, processor, packer, or distributor.
(h) The term "device" (except when used in paragraph (n) of
this section and in sections 301(i), 403(f), 502(c), and 602(c)) means
an instrument, apparatus, implement, machine, contrivance, im-
plant, in vitro reagent, or other similar or related article, including
any component, part, or accessory, which is—
(1) recognized in the official National Formulary, or the
United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals, or
(3) intended to affect the structure or any function of the
body of man or other animals, and
which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achieve-
ment of its primary intended purposes.
(i) The term "cosmetic" means (1) articles intended to be
rubbed, poured, sprinkled, or sprayed on, introduced into, or other-
wise applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance,
and (2) articles intended for use as a component of any such arti-
cles; except that such term shall not include soap.
(j) The term "official compendium" means the official United
States Pharmacopeia, official Homeopathic Pharmacopeia of the
United States, official National Formulary, or any supplement to
any of them.
(k) The term "label" means a display of written, printed, or
graphic matter upon the immediate container of any article; and a
requirement made by or under authority of this Act that any word,
statement, or other information appear on the label shall not be
considered to be complied with unless such word, statement, or
other information also appears on the outside container or wrapper,
if any there be, of the retail package of such article, or is easily leg-
ible through the outside container or wrapper.
(1) The term "immediate container" does not include package
liners.
(m) The term "labeling" means all labels and other written,
printed, or graphic matter (1) upon any article or any of its con-
tainers or wrappers, or (2) accompanying such article.
(n) If an article is alleged to be misbranded because the label-
ing or advertising is misleading, then in determining whether the
labeling or advertising is misleading there shall be taken into ac-
count (among other things) not only representations made or sug-
-------
Sec. 201 FEDERAL FOOD. DRUG, AND COSMETIC ACT 104
gested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling or advertising
fails to reveal facts material in the light of such representations or
material with respect to consequences which may result from the
use of the article to which the labeling or advertising relates under
the conditions of use prescribed in the labeling or advertising
thereof or under such conditions of use as are customary or usual.
(o) The representation of a drug, in its labeling, as an anti-
septic shall be considered to be a representation that it is a
germicide, except in the case of a drug purporting to be, or rep-
resented as, an antiseptic for inhibitory use as a wet dressing, oint-
ment, dusting powder, or such other use as involves prolonged con-
tact with the body.
(p) The term "new drug" means—
(1) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of
which is such that such drug is not generally recognized,
among experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, as safe and ef-
fective for use under the conditions prescribed, recommended,
or suggested in the labeling thereof, except that such a drug
not so recognized shall not be deemed to be a "new drug" if at
any time prior to the enactment of this Act it was subject to
the Food and Drugs Act of June 30, 1906, as amended, and if
at such time its labeling contained the same representations
concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of
which is such that such drug, as a result of investigations to
determine its safety and effectiveness for use under such condi-
tions, has become so recognized, but which has not, otherwise
than in such investigations, been used to a material extent or
for a material time under such conditions.
(q)(l) The term "pesticide chemical" means any substance that
is a pesticide within the meaning of the Federal Insecticide, Fun-
gicide, and Rodenticide Act, including all active and inert ingredi-
ents of such pesticide.
(2) The term "pesticide chemical residue" means a residue in
or on raw agricultural commodity or processed food of—
(A) a pesticide chemical; or
(B) any other added substance that is present on or in the
commodity or food primarily as a result of the metabolism or
other degradation of a pesticide chemical.
(3) Notwithstanding paragraphs (1) and (2), the Administrator
may by regulation except a substance from the definition of "pes-
ticide chemical" or "pesticide chemical residue" if—
(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natu-
ral causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commod-
ity or processed food; and
(B) the Administrator, after consultation with the Sec-
retary, determines that the substance more appropriately
-------
105 FEDERAL FOOD, DRUB. AND COSMETIC ACT Sec. 201
should be regulated under one or more provisions of this Act
other than sections 402(a)(2)(B) and 408.
(r) The term "raw agricultural commodity means any food in
its raw or natural state, including all fruits that are washed, col-
ored, or otherwise treated in their unpeeled natural form prior to
marketing.
(s) The term "food additive" means any substance the intended
use of which results or may reasonably be expected to result, di-
rectly or indirectly, in its becoming a component or otherwise af-
fecting the characteristics of any food (including any substance in-
tended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use), if
such substance is not generally recognized, among experts qualified
by scientific training and experience to evaluate its safety, as hav-
ing been adequately shown through scientific procedures (or, in the
case of a substance used in food prior to January 1, 1958, through
either scientific procedures or experience based on common use in
food) to be safe under the conditions of its intended use; except that
such term does not include—
(1) a pesticide chemical residue in or on a raw agricultural
commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or
approval granted prior to the enactment of this paragraph1
pursuant to this Act, the Poultry Products Inspection Act (21
U.S.C. 451 and the following) or the Meat Inspection Act of
March 4, 1907 (34 Stat. 1260), as amended and extended (21
U.S.C. 71 and the following);
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or in-
tended for use in, a dietary supplement.
(t)(D The term "color additive" means a material which—
(A) is a dye, pigment, or other substance made by a proc-
ess of synthesis or similar artifice, or extracted, isolated, or
otherwise derived, with or without intermediate or final
change of identity, from a vegetable, animal, mineral, or other
source, and
(B) when added or applied to a food, drug, or cosmetic, or
to the human body or any part thereof, is capable (alone or
through reaction with other substance) of imparting color
thereto;
except that such term does not include any material which the Sec-
retary, by regulation, determines is used (or intended to be used)
solely for a purpose or purposes other than coloring.
(2) The term "color" includes black, white, and intermediate
grays.
(3) Nothing in subparagraph (1) of this paragraph shall be con-
strued to apply to any pesticide chemical, soil or plant nutrient, or
other agricultural chemical solely because of its effect in aiding, re-
1 Probably should strike out "the enactment of this paragraph" and insert "September 6,
1958,".
-------
Sec. 201 FEDERAL FOOD, DRUG, AND COSMETIC ACT 106
tarding, or otherwise affecting, directly or indirectly, the growth or
other natural physiological processes of produce of the soil and
thereby affecting its color, whether before or after harvest.
(u) The term "safe," as used in paragraph (s) of this section
and in sections 409, 512, and 721, has reference to the health of
man or animal.
(v) The term "new animal drug" means any drug intended for
use for animals other than man, including any drug intended for
use in animal feed but not including such animal feed—
(1) the composition of which is such that such drug is not
generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effective-
ness of animal drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the label-
ing thereof; except that such a drug not so recognized shall not
be deemed to be a "new animal drug" if at any time prior to
June 25, 1938, it was subject to the Food and Drug Act of June
30, 1906, as amended, and if at such time its labeling con-
tained the same representations concerning the conditions of
its use; or
(2) the composition of which is such that such drug, as a
result of investigations to determine its safety and effective-
ness for use under such conditions, has become so recognized
but which has not, otherwise than in such investigations, been
used to a material extent or for a material time under such
conditions.
(w) The term "animal feed", as used in paragraph (w)1 of this
section, in section 512, and in provisions of this Act referring to
such paragraph or section, means an article which is intended for
use for food for animals other than man and which is intended for
use as a substantial source of nutrients in the diet of the animal,
and is not limited to a mixture intended to be the sole ration of
the animal.
(x) The term "informal hearing" means a hearing which is not
subject to section 554, 556, or 557 of title 5 of the United States
Code and which provides for the following:
(1) The presiding officer in the hearing shall be designated
by the Secretary from officers and employees of the Depart-
ment who have not participated in any action of the Secretary
which is the subject of the hearing and who are not directly re-
sponsible to an officer or employee of the Department who has
participated in any such action.
(2) Each party to the hearing shall have the right at all
times to be advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be
given reasonable notice of the matters to be considered at the
hearing, including a comprehensive statement of the basis for
the action taken or proposed by the Secretary which is the sub-
ject of the hearing and a general summary of the information
which will be presented by the Secretary at the hearing in sup-
port of such action.
*So in original. Probably should be paragraph "(v)".
-------
107 FEDERAL FOOD. DRUB, AND COSMETIC ACT Sec. 201
(4) At the hearing the parties to the hearing shall have the
right to hear a full and complete statement of the action of the
Secretary which is the subject of the hearing together with the
information and reasons supporting such action, to conduct
reasonable questioning, and to present any oral or written in-
formation relevant to such action.
(5) The presiding officer in such hearing shall prepare a
written report of the hearing to which shall be attached all
written material presented at the hearing. The participants in
the hearing shall be given the opportunity to review and cor-
rect or supplement the presiding officer's report of the hearing.
(6) The Secretary may require the hearing to be tran-
scribed. A party to the hearing shall have the right to have the
hearing transcribed at his expense. Any transcription of a
hearing shall be included in the presiding officer's report of the
hearing.
(y) The term "saccharin" includes calcium saccharin, sodium
saccharin, and ammonium saccharin.
(z) The term "infant formula" means a food which purports to
be or is represented for special dietary use solely as a food for in-
fants by reason of its simulation of human milk or its suitability
as a complete or partial substitute for human milk.
(aa) The term "abbreviated drug application" means an appli-
cation submitted under section 505(j) or 507 for the approval of a
drug that relies on the approved application of another drug with
the same active ingredient to establish safety and efficacy, and—
(1) in the case of section 306, includes a supplement to
such an application for a different or additional use of the drug
but does not include a supplement to such an application for
other than a different or additional use of the drug, and
(2) in the case of sections 307 and 308, includes any sup-
plement to such an application.
(bb) The term "knowingly" or "knew" means that a person,
with respect to information—
(1) has actual knowledge of the information, or
(2) acts in deliberate ignorance or reckless disregard of the
truth or falsity of the information.
(cc) For purposes of section 306, the term "high managerial
agent"—
(1) means—
(A) an officer or director of a corporation or an associa-
tion,
(B) a partner of a partnership, or
(C) any employee or other agent of a corporation, asso-
ciation, or partnership,
having duties such that the conduct of such officer, director,
partner, employee, or agent may fairly be assumed to represent
the policy of the corporation, association, or partnership, and
(2) includes persons having management responsibility
for—
(A) submissions to the Food and Drug Administration
regarding the development or approval of any drug prod-
uct,
-------
Sec. 201 FEDERAL FOOD, DRUG, AND COSMETIC ACT 108
(B) production, quality assurance, or quality control of
any drug product, or
(C) research and development of any drug product.
(dd) For purposes of sections 306 and 307, the term "drug prod-
uct" means a drug subject to regulation under section 505, 507,
512, or 802 of this Act or under section 351 of the Public Health
Service Act.
(ee) The term "Commissioner" means the Commissioner of
Food and Drugs.
(ff) The term "dietary supplement"—
(1) means a product (other than tobacco) intended to sup-
Element the diet that bears or contains one or more of the fol-
)wing dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement
the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or
combination of any ingredient described in clause (A), (B),
(C), (D), or (E);
(2) means a product that—
(A)(i) is intended for ingestion in a form described in
section 411(c)(l)(B)(i); or
(ii) complies with section 411(c)(l)(B)(ii);
(B) is not represented for use as a conventional food
or as a sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does—
(A) include an article that is approved as a new drug
under section 505, certified as an antibiotic under section
507, or licensed as a biologic under section 351 of the Pub-
lic Health Service Act (42 U.S.C. 262) and was, prior to
such approval, certification, or license, marketed as a die-
tary supplement or as a food unless the Secretary has is-
sued a regulation, after notice and comment, finding that
the article, when used as or in a dietary supplement under
the conditions of use and dosages set forth in the labeling
for such dietary supplement, is unlawful under section
402(f); and
(B) not include—
(i) an article that is approved as a new drug under
section 505, certified as an antibiotic under section
507, or licensed as a biologic under section 351 of the
Public Health Service Act (42 U.S.C. 262), or
(ii) an article authorized for investigation as a
new drug, antibiotic, or biological for which substan-
tial clinical investigations have been instituted and for
which the existence of such investigations has been
made public,
which was not before such approval, certification, licensing, or
authorization marketed as a dietary supplement or as a food
unless the Secretary, in the Secretary's discretion, has issued
-------
109 FEDERAL FOOD. DRUB, AND COSMETIC ACT Sec. 201
a regulation, after notice and comment, finding that the article
would be lawful under this Act.
Except for purposes of section 20 Kg), a dietary supplement shall be
deemed to be a food within the meaning of this Act.
(gg) The term "processed food" means any food other than a
raw agricultural commodity and includes any raw agricultural com-
modity that has been subject to processing, such as canning, cook-
ing, freezing, dehydration, or milling.
(hh) The term "Administrator" means the Administrator of the
United States Environmental Protection Agency.
-------
CHAPTER HI—PROHIBITED ACTS AND PENALTIES
PROHIBITED ACTS
SEC. 301. [331] The following acts and the causing thereof are
hereby prohibited:
(a) The introduction or delivery for introduction into interstate
commerce of any food, drug, device, or cosmetic that is adulterated
or misbranded.
(b) The adulteration or misbranding of any food, drug, device,
or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device,
or cosmetic that is adulterated or misbranded, and the delivery or
proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate
commerce of any article in violation of section 404 or 505.
(e) The refusal to permit access to or copying of any record as
required by section 412, 504, or 703; or the failure to establish or
maintain any record, or make any report, required under section
412, 504, 505 (i) or (k), 507(d) or (g), 512(a)(4)(C), 512 (j), (1) or (m),
515(f), or 519 or the refusal to permit access to or verification or
copying of any such required record.
(f) The refusal to permit entry or inspection as authorized by
section 704.
(g) The manufacture within any Territory of any food, drug, de-
vice, or cosmetic that is adulterated or misbranded.
(h) The giving of a guaranty or undertaking referred to in sec-
tion 333(c)(2) of this title which guaranty or undertaking is false,
except by a person who relied upon a guaranty or undertaking to
the same effect signed by, and containing the name and address of,
the person residing in the United States from whom he received in
good faith the food, drug, device, or cosmetic; or the giving of a
guaranty or undertaking referred to in section 333(c)(3) of this title
which guaranty or undertaking is false.
(i)(l) Forging, counterfeiting, simulating, or falsely represent-
ing, or without proper authority using any mark, stamp, tag, label,
or other identification device authorized or required by regulations
promulgated under the provisions of section 404, 506, 507, or 721.
(2) Making, selling, disposing of, or keeping in possession, con-
trol, or custody, or concealing any punch, die, plate, stone, or other
thing designed to print, imprint, or reproduce the trademark, trade
name, or other identifying mark, imprint, or device of another or
any likeness of any of the foregoing upon any drug or container or
labeling thereof so as to render such drugs a counterfeit drug.
(3) The doing of any act which causes a drug to be a counter-
feit drug, or the sale or dispensing, or the holding for sale or dis-
pensing, of a counterfeit drug.
110
-------
Ill FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 301
(j) The using by any person to his own advantage, or revealing,
other than to the Secretary or officers or employees of the Depart-
ment, or to the courts when relevant in any judicial proceeding
under this Act, any information acquired under authority of section
404, 409, 412, 505, 506, 507, 510, 512, 513, 514, 515, 516, 518, 519,
520, 704, 708, or 721 concerning any method or process which as
a trade secret is entitled to protection; or the violating of section
408(i)(2) or any regulation issued under that section..l This para-
graph does not authorize the withholding of information from ei-
ther House of Congress or from, to the extent of matter within its
jurisdiction, any committee or subcommittee of such committee or
any joint committee of Congress or any subcommittee of such joint
committee.
(k) The alteration, mutilation, destruction, obliteration, or re-
moval of the whole or any part of the labeling of, or the doing of
any other act with respect to, a food, drug, device, or cosmetic, if
such act is done while such article is held for sale (whether or not
the first sale) after shipment in interstate commerce and results in
such article being adulterated or misbranded.
(1) The using, on the labeling of any drug or device or in any
advertising relating to such drug or device, of any representation
or suggestion that approval of an application with respect to such
drug or device is in effect under section 505, 515, or 520(g), as the
case may be, or that such drug or device complies with the provi-
sions of such section.
(m) The sale or offering for sale of colored oleomargarine or col-
ored margarine, or the possession or serving of colored oleo-
margarine or colored margarine in violation of section 407(b) or
407(c).
(n) The using, in labeling, advertising or other sales promotion
of any reference to any report or analysis furnished in compliance
with section 704.
(o) In the case of a prescription drug distributed or offered for
sale in interstate commerce, the failure of the manufacturer, pack-
er, or distributor thereof to maintain for transmittal, or to trans-
mit, to any practitioner licensed by applicable State law to admin-
ister such drug who makes written request for information as to
such drug, true and correct copies of all printed matter which is re-
quired to be included in any package in which that drug is distrib-
uted or sold, or such other printed matter as is approved by the
Secretary. Nothing in this paragraph shall be construed to exempt
any person from any labeling requirement imposed by or under
other provisions of this Act.
(p) The failure to register in accordance with section 510, the
failure to provide any information required by section 510(j) or
510(k); or the failure to provide a notice required by section
510QX2).
(q)(l) The failure or refusal to (A) comply with any require-
ment prescribed under section 518 or 520(g), (B) furnish any notifi-
cation or other material or information required by or under sec-
'So in original. See the amendment made by section 403 of Public Law 104-170 (110 Stat.
1514).
-------
Sec. 302 FEDERAL FOOD. DRUE, AND COSMETIC ACT 112
tion 519 or 520(g), or (C) comply with a requirement under section
522.
(2) With respect to any device, the submission of any report
that is required by or under this Act that is false or misleading in
any material respect.
(r) The movement of a device in violation of an order under
section 304(g) or the removal or alteration of any mark or label re-
quired by the order to identify the device as detained.
(s) The failure to provide the notice required by section 412(c)
or 412(e), the failure to make the reports required by section
412(f)(l)(B), the failure to retain the records required by section
412(b)(4), or the failure to meet the requirements prescribed under
section 412(0(3).
(t) The importation of a drug in violation of section 801(d)(l),
the sale, purchase, or trade of a drug or drug sample or the offer
to sell, purchase, or trade a drug or drug sample in violation of sec-
tion 503(c), the sale, purchase, or trade of a coupon, the offer to
sell, purchase, or trade such a coupon, or the counterfeiting of such
a coupon in violation of section 503(c)(2), the distribution of a drug
sample in violation of section 503(d) or the failure to otherwise
comply with the requirements of section 503(d), or the distribution
of drugs in violation of section 503(e) or the failure to otherwise
comply with the requirements of section 503(e).
(u)1 The failure to comply with any requirements of the provi-
sions of, or any regulations or orders of the Secretary, under sec-
tion 512(a)(4)(A), 512(a)(4)(D), or 512(a)(5).
(v) The introduction or delivery for introduction into interstate
commerce of a dietary supplement that is unsafe under section 413.
(w) The making of a knowingly false statement in any record
or report required or requested under subparagraph (A) or (B) of
section 801(d)(3), the failure to submit or maintain records as re-
quired by sections 801(d)(3)(A) and 801(d)(3)(B), the release into
interstate commerce of any article imported into the United States
under section 801(d)(3) or any finished product made from such ar-
ticle (except for export in accordance with section 801(e) or 802 or
section 351(h) of the Public Health Service Act), or the failure to
export or destroy any component, part or accessory not incor-
porated into a drug, biological product or device that will be ex-
ported in accordance with section 801(e) or 802 or section 351(h) of
the Public Health Service Act.
INJUNCTION PROCEEDINGS
SEC. 302. [332] (a) The district courts of the United States and
the United States courts of the Territories shall have jurisdiction,
for cause shown to restrain violations of section 301, except para-
graphs (h), (i), and (j).
lrThis subsection was added by section 2(bXlXB) of P.L. 103-396. Subsections (c) and (d) of
section 2 of that Act state the following:
(c) REGULATIONS.—Not later than 2 years after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall promulgate regulations to implement paragraphs
(4)(A) and (5) of section 512(a) of the Federal Food, Drug, and Cosmetic Act (as amended by
subsection (a)).
(d) EFFECTIVE DATE.—The amendments made by this section shall take effect upon the adop-
tion of the final regulations under subsection (c).
-------
113 _ FEDERAL FOOD, DRUB, AND COSMETIC ACT _ Sec. 303
(b) In case of violation of an injunction or restraining order is-
sued under this section, which also constitutes a violation of this
Act, trial shall be by the court, or, upon demand of the accused, by
a jury.
PENALTIES
SEC. 303. [3333 (a)(l) Any person who violates a provision of
section 301 shall be imprisoned for not more than one year or fined
not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this sec-
tion 1, if any person commits such a violation after a conviction of
him under this section has become final, or commits such a viola-
tion with the intent to defraud or mislead, such person shall be im-
prisoned for not more than three years or fined not more than
$10,000 or both.
(b)(l) Notwithstanding subsection (a), any person who violates
section 301(t) by—
(A) knowingly importing a drug in violation of section
(B) knowingly selling, purchasing, or trading a drug or
drug sample or knowingly offering to sell, purchase, or trade
a drug or drug sample, in violation of section 503(c)(l),
(C) knowingly selling, purchasing, or trading a coupon,
knowingly offering to sell, purchase, or trade such a coupon, or
knowingly counterfeiting such a coupon, in violation of section
503(c)(2), or
(D) knowingly distributing drugs in violation of section
503(e)(2)(A),
shall be imprisoned for not more than 10 years or fined not more
than $250,000, or both.
(2) Any manufacturer or distributor who distributes drug sam-
ples by means other than the mail or common carrier whose rep-
resentative, during the course of the representative's employment
or association with that manufacturer or distributor, violated sec-
tion 301(t) because of a violation of section 503(c)(l) or violated any
State law prohibiting the sale, purchase, or trade of a drug sample
subject to section 503(b) or the offer to sell, purchase, or trade such
a drug sample shall, upon conviction of the representative for such
violation, be subject to the following civil penalties:
(A) A civil penalty of not more than $50,000 for each of the
first two such violations resulting in a conviction of any rep-
resentative of the manufacturer or distributor in any 10-year
period.
(B) A civil penalty of not more than $1,000,000 for each
violation resulting in a conviction of any representative after
the second conviction in any 10-year period.
For the purposes of this paragraph, multiple convictions of one or
more persons arising out of the same event or transaction, or a re-
lated series of events or transactions, shall be considered as one
violation.
(3) Any manufacturer or distributor who violates section 301(t)
because of a failure to make a report required by section
lThe words "of this section" should probably be stricken.
-------
Sec. 303 FEDERAL FOOD, DRU6, AND COSMETIC ACT TI4
503(d)(3)(E) shall be subject to a civil penalty of not more than
$100,000.
(4)(A) If a manufacturer or distributor or any representative of
such manufacturer or distributor provides information leading to
the institution of a criminal proceeding against, and conviction of,
any representative of that manufacturer or distributor for a viola-
tion of section 301(t) because of a sale, purchase, or trade or offer
to purchase, sell, or trade a drug sample in violation of section
503(c)(l) or for a violation of State law prohibiting the sale, pur-
chase, or trade or offer to sell, purchase, or trade a drug sample,
the conviction of such representative shall not be considered as a
violation for purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a man-
ufacturer or distributor relating to the conviction of a representa-
tive of such manufacturer or distributor for the sale, purchase, or
trade of a drug or the offer to sell, purchase, or trade a drug, it
is shown, by clear and convincing evidence—
(i) that the manufacturer or distributor conducted, before
the institution of a criminal proceeding against such represent-
ative for the violation which resulted in such conviction, an in-
vestigation of events or transactions which would have led to
the reporting of information leading to the institution of a
criminal proceeding against, and conviction of, such represent-
ative for such purchase, sale, or trade or offer to purchase, sell,
or trade, or
(ii) that, except in the case of the conviction of a represent-
ative employed in a supervisory function, despite diligent im-
plementation by the manufacturer or distributor of an inde-
pendent audit and security system designed to detect such a
violation, the manufacturer or distributor could not reasonably
have been expected to have detected such violation,
the conviction of such representative shall not be considered as a
conviction for purposes of paragraph (2).
(5) If a person provides information leading to the institution
of a criminal proceeding against, and conviction of, a person for a
violation of section 301(t) because of the sale, purchase, or trade of
a drug sample or the offer to sell, purchase, or trade a drug sample
in violation of section 503(c)(l), such person shall be entitled to
one-half of the criminal fine imposed and collected for such viola-
tion but not more than $125,000.
(c) No person shall be subject to the penalties of subsection
(a)(l) of this section, (1) for having received in interstate commerce
any article and delivered it or proffered delivery of it, if such deliv-
ery or proffer was made in good faith, unless he refuses to furnish
on request of an officer or employee duly designated by the Sec-
retary the name and address of the person from whom he pur-
chased or received such article and copies of all documents, if any
there be, pertaining to the delivery of the article to him; or (2) for
having violated section 301(a) or (d), if he establishes a guaranty
or undertaking signed by, and containing the name and address of,
the person residing in the United States from whom he received in
good faith the article, to the effect, in case of an alleged violation
of section 301(a), that such article is not adulterated or mis-
branded, within the meaning of this Act, designating this Act, or
-------
N5 FEDERAL FOOD. DRUB, AND COSMETIC ACT Sec. 303
to the effect, in case of an alleged violation of section 301(d), that
such article is not an article which may not, under the provisions
of section 404 or 505, be introduced into interstate commerce; or (3)
for having violated section 301(a), where the violation exists be-
cause the article is adulterated by reason of containing a color ad-
ditive not from a batch certified in accordance with regulations pro-
mulgated by the Secretary under this Act, if such person estab-
lishes a guaranty or undertaking signed by, and containing the
name and address of, the manufacturer of the color additive, to the
effect that such color additive was from a batch certified in accord-
ance with the applicable regulations promulgated by the Secretary
under this Act; or (4) for having violated section 301 (b), (c), or (k)
by failure to comply with section 502(f) in respect to an article re-
ceived in interstate commerce to which neither section 503(a) nor
section 503(b)(l) is applicable, if the delivery or proffered delivery
was made in good faith and the labeling at the time thereof con-
tained the same directions for use and warning statements as were
contained in the labeling at the time of such receipt of such article;
or (5) for having violated section 301(i)(2) if sucn person acted in
good faith and had no reason to believe that use of the punch, die,
plate, stone, or other thing involved would result in a drug being
a counterfeit drug, or for having violated section 301(i)(3) if the
person doing the act or causing it to be done acted in good faith
and had no reason to believe that the drug was a counterfeit drug.
(d) No person shall be subject to the penalties of subsection
(a)(l) of this section for a violation of section 301 involving mis-
branded food if the violation exists solely because the food is mis-
branded under section 403(a)(2) because of its advertising.
(e)(l) Except as provided in paragraph (2), any person who dis-
tributes or possesses with the intent to distribute any anabolic
steriod for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than three years or fined under title 18, United States Code,
or both.
(2) Any person who distributes or possesses with the intent to
distribute to an individual under 18 years of age, any anabolic ster-
oid for any use in humans other than the treatment of disease pur-
suant to the order of a physician shall be imprisoned for not more
than six years or fined under title 18, United States Code, or both.
(f)(l) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human growth
hormone for any use in humans other than the treatment of a dis-
ease or other recognized medical condition, where such use has
been authorized by the Secretary of Health and Human Services
under section 505 and pursuant to the order of a physician, is
guilty of an offense punishable by not more than 5 years in prison,
such fines as are authorized by title 18, United States Code, or
both.
(2) Whoever commits any offense set forth in paragraph (1) and
such offense involves an individual under 18 years of age is punish-
able by not more than 10 years imprisonment, such fines as are au-
thorized by title 18, United States Code, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of
this subsection shall be considered a felony violation of the Con-
-------
Sec. 303 FEDERAL FOOD, DRUB, AND COSMETIC ACT 116
trolled Substances Act for the purposes of forfeiture under section
413 of such Act.
(4) As used in this subsection the term "human growth hor-
mone" means somatrem, somatropin, or an analogue of either of
them.
(5) The Drug Enforcement Administration is authorized to in-
vestigate offenses punishable by this subsection.
(g)(l)(A) Except as provided in subparagraph (B), any person
who violates a requirement of this Act which relates to devices
shall be liable to the United States for a civil penalty in an amount
not to exceed $15,000 for each such violation, and not to exceed
$1,000,000 for all such violations adjudicated in a single proceed-
ing.
(B) Subparagraph (A) shall not apply—
(i) to any person who violates the requirements of section
519(a) or 520(f) unless such violation constitutes (I) a signifi-
cant or knowing departure from such requirements, or (II) a
risk to public health,
(ii) to any person who commits minor violations of section
519(e) or 519(f) (only with respect to correction reports) if such
person demonstrates substantial compliance with such section,
or
(iii) to violations of section 501(a)(2)(A) which involve one
or more devices which are not defective.
(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article of food
that is adulterated within the meaning of section 402(a)(2)(B) shall
be subject to a civil money penalty of not more than $50,000 in the
case of an individual and $250,000 in the case of any other person
for such introduction or delivery, not to exceed $500,000 for all
such violations adjudicated in a single proceeding.
(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses a civil
penalty against any person under this paragraph, the Secretary
may not use the criminal authorities under this section to sanction
such person for the introduction or delivery for introduction into
interstate commerce of the article of food that is adulterated. If the
Secretary assesses a civil penalty against any person under this
paragraph, the Secretary may not use the seizure authorities of
section 304 or the injunction authorities of section 302 with respect
to the article of food that is adulterated.
(C) In a hearing to assess a civil penalty under this paragraph,
the presiding officer shall have the same authority with regard to
compelling testimony or production of documents as a presiding of-
ficer has under section 408(g)(2)(B). The third sentence of para-
graph (3)(A) shall not apply to any investigation under this para-
graph.
(3)(A) A civil penalty under paragraph (1) or (2) shall be as-
sessed by the Secretary by an order made on the record after op-
portunity for a hearing provided in accordance with this subpara-
graph and section 554 of title 5, United States Code. Before issuing
such an order, the Secretary shall give written notice to the person
to be assessed a civil penalty under such order of the Secretary's
proposal to issue such order and provide such person an oppor-
-------
117 FEDERAL FOOD, DRUB. AND COSMETIC ACT Sec. 304
tunity for a hearing on the order. In the course of any investiga-
tion, the Secretary may issue subpoenas requiring the attendance
and testimony of witnesses and the production of evidence that re-
lates to the matter under investigation.
(B) In determining the amount of a civil penalty, the Secretary
shall take into account the nature, circumstances, extent, and grav-
ity of the violation or violations and, with respect to the violator,
ability to pay, effect on ability to continue to do business, any his-
tory of prior such violations, the degree of culpability, and such
other matters as justice may require.
(C) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed under
paragraph (1) or (2). The amount of such penalty, when finally de-
termined, or the amount agreed upon in compromise, may be de-
ducted from any sums owing by the United States to the person
charged.
(4) Any person who requested, in accordance with paragraph
(3)(A), a hearing respecting the assessment of a civil penalty and
who is aggrieved by an order assessing a civil penalty may file a
petition for judicial review of such order with the United States
Court of Appeals for the District of Columbia Circuit or for any
other circuit in which such person resides or transacts business.
Such a petition may only be filed within the 60-day period begin-
ning on the date the order making such assessment was issued.
(5) If any person fails to pay an assessment of a civil penalty—
(A) after the order making the assessment becomes final,
and if such person does not file a petition for judicial review
of the order in accordance with paragraph (4), or
(B) after a court in an action brought under paragraph (4)
has entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus in-
terest at currently prevailing rates from the date of the expiration
of the 60-day period referred to in paragraph (4) or the date of such
final judgment, as the case may be) in an action brought in any ap-
propriate district court of the United States. In such an action, the
validity, amount, and appropriateness of such penalty shall not be
subject to review.
SEIZURE
SEC. 304. [334] (a)(l) Any article of food, drug, or cosmetic
that is adulterated or misbranded when introduced into or while in
interstate commerce or while held for sale (whether or not the first
sale) after shipment in interstate commerce, or which may not,
under the provisions of section 404 or 505, be introduced into inter-
state commerce, shall be liable to be proceeded against while in
interstate commerce, or at any time thereafter, on libel of informa-
tion and condemned in any district court of the United States or
United States court of a Territory within the jurisdiction of which
the article is found. No libel for condemnation shall be instituted
under this Act, for any alleged misbranding if there is pending in
any court a libel for condemnation proceeding under this Act based
upon the same alleged misbranding, and not more than one such
proceeding shall be instituted if no such proceeding is so pending,
-------
Sec. 304 FEDERAL FOOD, DRUB, AND COSMETIC ACT 118
except that such limitations shall not apply (A) when such mis-
branding has been the basis of a prior judgment in favor of the
United States, in a criminal, injunction, or libel for condemnation
proceeding under this Act, or (B) when the Secretary has probable
cause to believe from facts found, without hearing, by him or any
officer or employee of the Department that the misbranded article
is dangerous to health, or that the labeling of the misbranded arti-
cle is fraudulent, or would be in a material respect misleading to
the injury or damage of the purchaser or consumer. In any case
where the number of libel for condemnation proceedings is limited
as above provided the proceeding pending or instituted shall, on
application of the claimant, seasonably made, be removed for trial
to any district agreed upon by stipulation between the parties, or,
in case of failure to so stipulate within a reasonable time, the
claimant may apply to the court of the district in which the seizure
has been made, and such court (after giving the United States at-
torney for such district reasonable notice and opportunity to be
heard) shall by order, unless good cause to the contrary is shown,
specify a district of reasonable proximity to the claimant's principal
place of business to which the case shall be removed for trial.
(2) The following shall be liable to be proceeded against at any
time on libel of information and condemned in any district court of
the United States or United States court of a Territory within the
jurisdiction of which they are found: (A) Any drug that is a coun-
terfeit drug, (B) Any container of a counterfeit drug, (C) Any
punch, die, plate, stone, labeling, container, or other thing used or
designed for use in making a counterfeit drug or drugs, and (D)
Any adulterated or misbranded device.
(3)(A) Except as provided in subparagraph (B), no libel for con-
demnation may be instituted under paragraph (1) or (2) against
any food which—
(i) is misbranded under section 403(a)(2) because of its ad-
vertising, and
(ii) is being held for sale to the ultimate consumer in an
establishment other than an establishment owned or operated
by a manufacturer, packer, or distributor of the food.
(B) A libel for condemnation may be instituted under para-
graph (1) or (2) against a food described in subparagraph (A) if—
(i)(I) the food's advertising which resulted in the food being
misbranded under section 403(a)(2) was disseminated in the
establishment in which the food is being held for sale to the
ultimate consumer,
(II) such advertising was disseminated by, or under the di-
rection of, the owner or operator of such establishment, or
(III) all or part of the cost of such advertising was paid by
such owner or operator; and
(ii) the owner or operator of such establishment used such
advertising in the establishment to promote the sale of the
food.
(b) The article, equipment, or other thing proceeded against
shall be liable to seizure by process pursuant to the libel, and the
procedure in cases under this section shall conform, as nearly as
may be, to the procedure in admiralty; except that on demand of
either party any issue of fact joined in any such case shall be tried
-------
V[9 FEDERAL FOOD, DRUG. AND COSMETIC ACT Sec. 304
by jury. When libel for condemnation proceedings under this sec-
tion, involving the same claimant and the same issues of adultera-
tion or misbranding, are pending in two or more jurisdictions, such
pending proceedings, upon application of the claimant seasonably
made to the court of one such jurisdiction, shall be consolidated for
trial by order of such court, and tried in (1) any district selected
by the claimant where one of such proceedings is pending; or (2)
a district agreed upon by stipulation between the parties. If no
order for consolidation is so made within a reasonable time, the
claimant may apply to the court of one such jurisdiction, and such
court (after giving the United States attorney for such district rea-
sonable notice and opportunity to be heard) shall by order, unless
good cause to the contrary is shown, specify a district of reasonable
proximity to the claimant's principal place of business, in which all
such pending proceedings shall be consolidated for trial and tried.
Such order of consolidation shall not apply so as to require the re-
moval of any case the date for trial of which has been fixed. The
court granting such order shall give prompt notification thereof to
the other courts having jurisdiction of the cases covered thereby.
(c) The court at any time after seizure up to a reasonable time
before trial shall by order allow any party to a condemnation pro-
ceeding, his attorney or agent, to obtain a representative sample of
the article seized and a true copy of the analysis, if any, on which
the proceeding is based and the identifying marks or numbers, if
any, of the packages from which the samples analyzed were ob-
tained.
(d)(l) Any food, drug, device, or cosmetic condemned under this
section shall, after entry of the decree, be disposed of by destruc-
tion or sale as the court may, in accordance with the provisions of
this section, direct and the proceeds thereof, if sold, less the legal
costs and charges, shall be paid into the Treasury of the United
States; but such article shall not be sold under such decree con-
trary to the provisions of this Act or the laws of the jurisdiction in
which sold. After entry of the decree and upon the payment of the
costs of such proceedings and the execution of a good and sufficient
bond conditioned that such article shall not be sold or disposed of
contrary to the provisions of this Act or the laws of any State or
Territory in which sold, the court may by order direct that such ar-
ticle be delivered to the owner thereof to be destroyed or brought
into compliance with the provisions of this Act under the super-
vision of an officer or employee duly designated by the Secretary,
and the expenses of such supervision shall be paid by the person
obtaining release of the article under bond. If the article was im-
ported into the United States and the person seeking its release es-
tablishes (A) that the adulteration, misbranding, or violation did
not occur after the article was imported, and (B) that he had no
cause for believing that it was adulterated, misbranded, or in viola-
tion before it was released from customs custody, the court may
permit the article to be delivered to the owner for exportation in
lieu of destruction upon a showing by the owner that all of the con-
ditions of section 801(e) can and will be met. The provisions of this
sentence shall not apply where condemnation is based upon viola-
tion of section 402(a) (1), (2), or (6), section 501(a)(3), section 502(j),
or section 601 (a) or (d). Where such exportation is made to the
-------
Sec. 304 FEDERAL FOOD. DRUB, AND COSMETIC ACT 120
original foreign supplier, then paragraphs (1) and (2) of section
801(e) and the preceding sentence shall not be applicable; and in
all cases of exportation the bond shall be conditioned that the arti-
cle shall not be sold or disposed of until the applicable conditions
of section 801(e) have been met. Any article condemned by reason
of its being an article which may not, under section 404 or 505, be
introduced into interstate commerce, shall be disposed of by de-
struction.
(2) The provisions of paragraph (1) of this subsection shall, to
the extent deemed appropriate by the court, apply to any equip-
ment or other thing which is not otherwise within the scope of such
paragraph and which is referred to in paragraph (2) of subsection
(a).
(3) Whenever in any proceeding under this section, involving
paragraph (2) of subsection (a), the condemnation of any equipment
or thing (other than a drug) is decreed, the court shall allow the
claim of any claimant, to the extent of such claimant's interest, for
remission or mitigation of such forfeiture if such claimant proves
to the satisfaction of the court (i) that he has not committed or
caused to be committed any prohibited act referred to in such para-
graph (2) and has no interest in any drug referred to therein, (ii)
that he has an interest in such equipment or other thing as owner
or lienor or otherwise, acquired by him in good faith, and (iii) that
he at no time had any knowledge or reason to believe that such
equipment or other thing was being or would be used in, or to fa-
cilitate, the violation of laws of the United States relating to coun-
terfeit drugs.
(e) When a decree of condemnation is entered against the arti-
cle, court costs and fees, and storage and other proper expenses,
shall be awarded against the person, if any, intervening as claim-
ant of the article.
(f) In the case of removal for trial of any case as provided by
subsection (a) or (b)—
(1) The clerk of the court from which removal is made
shall promptly transmit to the court in which the case is to be
tried all records in the case necessary in order that such court
may exercise jurisdiction.
(2) The court to which such case was removed shall have
the powers and be subject to the duties for purposes of such
case, which the court from which removal was made would
have had, or to which such court would have been subject, if
such case had not been removed.
(g)(l) If during an inspection conducted under section 704 of a
facility or a vehicle, a device which the officer or employee making
the inspection has reason to believe is adulterated or misbranded
is found in such facility or vehicle, such officer or employee may
order the device detained (in accordance with regulations pre-
scribed by the Secretary) for a reasonable period which may not ex-
ceed twenty days unless the Secretary determines that a period of
detention greater than twenty days is required to institute an ac-
tion under subsection (a) or section 302, in which case he may au-
thorize a detention period of not to exceed thirty days. Regulations
of the Secretary prescribed under this paragraph shall require that
before a device may be ordered detained under this paragraph the
-------
121 FEDERAL FOOD. DRUG, AND COSMETIC ACT Sec. 306
Secretary or an officer or employee designated by the Secretary ap-
prove such order. A detention order under this paragraph may re-
quire the labeling or marking of a device during the period of its
detention for the purpose of identifying the device as detained. Any
person who would be entitled to claim a device if it were seized
under subsection (a) may appeal to the Secretary a detention of
such device under this paragraph. Within five days of the date an
appeal of a detention is filed with the Secretary, the Secretary
shall after affording opportunity for an informal hearing by order
confirm the detention or revoke it.
(2)(A) Except as authorized by subparagraph (B), a device sub-
ject to a detention order issued under paragraph (1) shall not be
moved by any person from the place at which it is ordered detained
until—
(i) released by the Secretary, or
(ii) the expiration of the detention period applicable to
such order,
whichever occurs first.
(B) A device subject to a detention order under paragraph (1)
may be moved—
(i) in accordance with regulations prescribed by the Sec-
retary, and
(ii) if not in final form for shipment, at the discretion of
the manufacturer of the device for the purpose of completing
the work required to put it in such form.
HEARING BEFORE REPORT OF CRIMINAL VIOLATION
SEC. 305. [335] Before any violation of this Act is reported by
the Secretary to any United States attorney for institution of a
criminal proceeding, the person against whom such proceeding is
contemplated shall be given appropriate notice and an opportunity
to present his views, either orally or in writing, with regard to such
contemplated proceeding.
DEBARMENT, TEMPORARY DENIAL OF APPROVAL, AND SUSPENSION
SEC. 306. [335al (a) MANDATORY DEBARMENT.—
(1) CORPORATIONS, PARTNERSHIPS, AND ASSOCIATIONS.—If
the Secretary finds that a person other than an individual has
been convicted, after the date of the enactment of this section,
of a felony under Federal law for conduct relating to the devel-
opment or approval, including the process for development or
approval, of any abbreviated drug application, the Secretary
shall debar such person from submitting, or assisting in the
submission of, any such application.
(2) INDIVIDUALS.—If the Secretary finds that an individual
has been convicted of a felony under Federal law for conduct—
(A) relating to the development or approval, including
the process for development or approval, of any drug prod-
uct, or
(B) otherwise relating to the regulation of any drug
product under this Act,
-------
Sec. 306 FEDERAL FOOD, DRUG, AND COSMETIC ACT 122
the Secretary shall debar such individual from providing serv-
ices in any capacity to a person that has an approved or pend-
ing drug product application.
(b) PERMISSIVE DEBARMENT.—
(1) IN GENERAL.—The Secretary, on the Secretary's own
initiative or in response to a petition, may, in accordance with
paragraph (2), debar—
(A) a person other than an individual from submitting
or assisting in the submission of any abbreviated drug ap-
plication, or
(B) an individual from providing services in any capac-
ity to a person that has an approved or pending drug prod-
uct application.
(2) PERSONS SUBJECT TO PERMISSIVE DEBARMENT.—The fol-
lowing persons are subject to debarment under paragraph (1):
(A) CORPORATIONS, PARTNERSHIPS, AND ASSOCIA-
TIONS.—Any person other than an individual that the Sec-
retary finds has been convicted—
(i) for conduct that—
(I) relates to the development or approval, in-
cluding the process for the development or ap-
proval, of any abbreviated drug application; and
(II) is a felony under Federal law (if the per-
son was convicted before the date of the enact-
ment of this section), a misdemeanor under Fed-
eral law, or a felony under State law, or
(ii) of a conspiracy to commit, or aiding or abet-
ting, a criminal offense described in clause (i) or a fel-
ony described in subsection (a)(l),
if the Secretary finds that the type of conduct which
served as the basis for such conviction undermines the
process for the regulation of drugs.
(B) INDIVIDUALS.—
(i) Any individual whom the Secretary finds has
been convicted of—
(I) a misdemeanor under Federal law or a fel-
ony under State law for conduct relating to the
development or approval, including the process for
development or approval, of any drug product or
otherwise relating to the regulation of drug prod-
ucts under this Act, or
(II) a conspiracy to commit, or aiding or abet-
ting, such criminal offense or a felony described in
subsection (a)(2),
if the Secretary finds that the type of conduct which
served as the basis for such conviction undermines the
process for the regulation of drugs.
(ii) Any individual whom the Secretary finds has
been convicted of—
(I) a felony which is not described in sub-
section (a)(2) or clause (i) of this subparagraph
and which involves bribery, payment of illegal
gratuities, fraud, perjury, false statement, rack-
eteering, blackmail, extortion, falsification or de-
-------
123 FEDERAL FOOD, DRUB. AND COSMETIC ACT Sec. 306
struction of records, or interference with, obstruc-
tion of an investigation into, or prosecution of, any
criminal offense, or
(II) a conspiracy to commit, or aiding or abet-
ting, such felony,
if the Secretary finds, on the basis of the conviction of
such individual and other information, that such indi-
vidual has demonstrated a pattern of conduct suffi-
cient to find that there is reason to believe that such
individual may violate requirements under this Act re-
lating to drug products.
(iii) Any individual whom the Secretary finds ma-
terially participated in acts that were the basis for a
conviction for an offense described in subsection (a) or
in clause (i) or (ii) for which a conviction was obtained,
if the Secretary finds, on the basis of such participa-
tion and other information, that such individual has
demonstrated a pattern of conduct sufficient to find
that there is reason to believe that such individual
may violate requirements under this Act relating to
drug products.
(iv) Any high managerial agent whom the Sec-
retary finds—
(I) worked for, or worked as a consultant for,
the same person as another individual during the
period in which such other individual took actions
for which a felony conviction was obtained and
which resulted in the debarment under subsection
(a)(2), or clause (i), of such other individual,
(II) had actual knowledge of the actions de-
scribed in subclause (I) of such other individual, or
took action to avoid such actual knowledge, or
failed to take action for the purpose of avoiding
such actual knowledge,
(III) knew that the actions described in sub-
clause (I) were violative of law, and
(IV) did not report such actions, or did not
cause such actions to be reported, to an officer,
employee, or agent of the Department or to an ap-
propriate law enforcement officer, or failed to take
other appropriate action that would have ensured
that the process for the regulation of drugs was
not undermined, within a reasonable time after
such agent first knew of such actions,
if the Secretary finds that the type of conduct which
served as the basis for such other individual's convic-
tion undermines the process for the regulation of
drugs.
(3) STAY OF CERTAIN ORDERS.—An order of the Secretary
under clause (iii) or (iv) of paragraph (2)(B) shall not take ef-
fect until 30 days after the order has been issued.
(c) DEBARMENT PERIOD AND CONSIDERATIONS.—
(1) EFFECT OF DEBARMENT.—The Secretary—
-------
Sec. 306 FEDERAL FOOD, DRUB, AND COSMETIC ACT 124
(A) shall not accept or review (other than in connec-
tion with an audit under this section) any abbreviated
drug application submitted by or with the assistance of a
person debarred under subsection (a)(l) or (b)(2)(A) during
the period such person is debarred,
(B) shall, during the period of a debarment under sub-
section (a)(2) or (b)(2)(B), debar an individual from provid-
ing services in any capacity to a person that has an ap-
proved or pending drug product application and shall not
accept or review (other than in connection with an audit
under this section) an abbreviated drug application from
such individual, and
(C) shall, if the Secretary makes the finding described
in paragraph (6) or (7) of section 307(a), assess a civil pen-
alty in accordance with section 307.
(2) DEBARMENT PERIODS.—
(A) IN GENERAL.—The Secretary shall debar a person
under subsection (a) or (b) for the following periods:
(i) The period of debarment of a person (other
than an individual) under subsection (a)(l) shall not
be less than 1 year or more than 10 years, but if an
act leading to a subsequent debarment under sub-
section (a) occurs within 10 years after such person
has been debarred under subsection (a)(l), the period
of debarment shall be permanent.
(ii) The debarment of an individual under sub-
section (a)(2) shall be permanent.
(iii) The period of debarment of any person under
subsection (b)(2) shall not be more than 5 years.
The Secretary may determine whether debarment periods
shall run concurrently or consecutively in the case of a
person debarred for multiple offenses.
(B) NOTIFICATION.—Upon a conviction for an offense
described in subsection (a) or (b) or upon execution of an
agreement with the United States to plead guilty to such
an offense, the person involved may notify the Secretary
that the person acquiesces to debarment and such person's
debarment shall commence upon such notification.
(3) CONSIDERATIONS.—In determining the appropriateness
and the period of a debarment of a person under subsection (b)
and any period of debarment beyond the minimum specified in
subparagraph (A)(i) of paragraph (2), the Secretary shall con-
sider where applicable—
(A) the nature and seriousness of any offense involved,
(B) the nature and extent of management participa-
tion in any offense involved, whether corporate policies
and practices encouraged the offense, including whether
inadequate institutional controls contributed to the of-
fense,
(C) the nature and extent of voluntary steps to miti-
gate the impact on the public of any offense involved, in-
cluding the recall or the discontinuation of the distribution
of suspect drugs, full cooperation with any investigations
(including the extent of disclosure to appropriate authori-
-------
125 FEDERAL FOOD, DRUE, AND COSMETIC ACT Sec. 306
ties of all wrongdoing), the relinquishing of profits on drug
approvals fraudulently obtained, and any other actions
taken to substantially limit potential or actual adverse ef-
fects on the public health,
(D) whether the extent to which changes in ownership,
management, or operations have corrected the causes of
any offense involved and provide reasonable assurances
that the offense will not occur in the future,
(E) whether the person to be debarred is able to
present adequate evidence that current production of
drugs subject to abbreviated drug applications and all
pending abbreviated drug applications are free of fraud or
material false statements, and
(F) prior convictions under this Act or under other
Acts involving matters within the jurisdiction of the Food
and Drug Administration.
(d) TERMINATION OF DEBARMENT.—
(1) APPLICATION.—Any person that is debarred under sub-
section (a) (other than a person permanently debarred) or any
person that is debarred under subsection (b) may apply to the
Secretary for termination of the debarment under this sub-
section. Any information submitted to the Secretary under this
paragraph does not constitute an amendment or supplement to
pending or approved abbreviated drug applications.
(2) DEADLINE.—The Secretary shall grant or deny any ap-
plication respecting a debarment which is submitted under
paragraph (1) within 180 days of the date the application is
submitted.
(3) ACTION BY THE SECRETARY.—
(A) CORPORATIONS.—
(i) CONVICTION REVERSAL.—If the conviction which
served as the basis for the debarment of a person
under subsection (a)(l) or (b)(2)(A) is reversed, the
Secretary shall withdraw the order of debarment.
(ii) APPLICATION.—Upon application submitted
under paragraph (1), the Secretary shall terminate the
debarment of a person if the Secretary finds that—
(I) changes in ownership, management, or op-
erations have fully corrected the causes of the of-
fense involved and provide reasonable assurances
that the offense will not occur in the future, and
(II) sufficient audits, conducted by the Food
and Drug Administration or by independent ex-
perts acceptable to the Food and Drug Adminis-
tration, demonstrate that pending applications
and the development of drugs being tested before
the submission of an application are free of fraud
or material false statements.
In the case of persons debarred under subsection
(a)(l), such termination shall take effect no earlier
than the expiration of one year from the date of the
debarment.
(B) INDIVIDUALS.—
-------
Sec. 306 FEDERAL FOOD, DRUB, AND COSMETIC ACT 126
(i) CONVICTION REVERSAL.—If the conviction which
served as the basis for the debarment of an individual
under subsection (a)(2) or clause (i), (ii), (iii), or (iv) of
subsection (b)(2)(B) is reversed, the Secretary shall
withdraw the order of debarment.
(ii) APPLICATION.—Upon application submitted
under paragraph (1), the Secretary shall terminate the
debarment of an individual who has been debarred
under subsection (b)(2)(B) if such termination serves
the interests of justice and adequately protects the in-
tegrity of the drug approval process.
(4) SPECIAL TERMINATION.—
(A) APPLICATION.—Any person that is debarred under
subsection (a)(l) (other than a person permanently
debarred under subsection (c)(2)(A)(i)) or any individual
who is debarred under subsection (a)(2) may apply to the
Secretary for special termination of debarment under this
subsection. Any information submitted to the Secretary
under this subparagraph does not constitute an amend-
ment or supplement to pending or approved abbreviated
drug applications.
(B) CORPORATIONS.—Upon an application submitted
under subparagraph (A), the Secretary may take the ac-
tion described in subparagraph (D) if the Secretary, after
an informal hearing, finds that—
(i) the person making the application under sub-
paragraph (A) has demonstrated that the felony con-
viction which was the basis for such person's debar-
ment involved the commission of an offense which was
not authorized, requested, commanded, performed, or
recklessly tolerated by the board of directors or by a
high managerial agent acting on behalf of the person
within the scope of the board's or agent's office or em-
ployment,
(ii) all individuals who were involved in the com-
mission of the offense or who knew or should have
known of the offense have been removed from employ-
ment involving the development or approval of any
drug subject to section 505 or 507,
(iii) the person fully cooperated with all investiga-
tions and promptly disclosed all wrongdoing to the ap-
propriate authorities, and
(iv) the person acted to mitigate any impact on the
public of any offense involved, including the recall, or
the discontinuation of the distribution, of any drug
with respect to which the Secretary requested a recall
or discontinuation of distribution due to concerns
about the safety or efficacy of the drug.
(C) INDIVIDUALS.—Upon an application submitted
under subparagraph (A), the Secretary may take the ac-
tion described in subparagraph (D) if the Secretary, after
an informal hearing, finds that such individual has pro-
vided substantial assistance in the investigations or pros-
ecutions of offenses which are described in subsection (a)
-------
127 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 306
or (b) or which relate to any matter under the jurisdiction
of the Food and Drug Administration.
(D) SECRETARIAL ACTION.—The action referred to in
subparagraphs (B) and (C) is—
(i) in the case of a person other than an individ-
ual—
(I) terminating the debarment immediately, or
(II) limiting the period of debarment to less
than one year, and
(ii) in the case of an individual, limiting the period
of debarment to less than permanent but to no less
than 1 year,
whichever best serves the interest of justice and protects
the integrity of the drug approval process.
(e) PUBLICATION AND LIST OF DEBARRED PERSONS.—The Sec-
retary shall publish in the Federal Register the name of any person
debarred under subsection (a) or (b), the effective date of the debar-
ment, and the period of the debarment. The Secretary shall also
maintain and make available to the public a list, updated no less
often than quarterly, of such persons, of the effective dates and
minimum periods of such debarments, and of the termination of
debarments.
(f) TEMPORARY DENIAL OF APPROVAL.—
(1) IN GENERAL.—The Secretary, on the Secretary's own
initiative or in response to a petition, may, in accordance with
paragraph (3), refuse by order, for the period prescribed by
paragraph (2), to approve any abbreviated drug application
submitted by any person—
(A) if such person is under an active Federal criminal
investigation in connection with an action described in
subparagraph (B),
(B) if the Secretary finds that such person—
(i) has bribed or attempted to bribe, has paid or
attempted to pay an illegal gratuity, or has induced or
attempted to induce another person to bribe or pay an
illegal gratuity to any officer, employee, or agent of the
Department of Health and Human Services or to any
other Federal, State, or local official in connection with
any abbreviated drug application, or has conspired to
commit, or aided or abetted, such actions, or
(ii) has knowingly made or caused to be made a
pattern or practice of false statements or misrepresen-
tations with respect to material facts relating to any
abbreviated drug application, or the production of any
drug subject to an abbreviated drug application, to any
officer, employee, or agent of the Department of
Health and Human Services, or has conspired to com-
mit, or aided or abetted, such actions, and
(C) if a significant question has been raised regard-
ing—
(i) the integrity of the approval process with re-
spect to such abbreviated drug application, or
(ii) the reliability of data in or concerning such
person's abbreviated drug application.
-------
Sec. 306 FEDERAL FOOD, DRU6, AND COSMETIC ACT 128
Such an order may be modified or terminated at any time.
(2) APPLICABLE PERIOD.—
(A) IN GENERAL.—Except as provided in subparagraph
(B), a denial of approval of an application of a person
under paragraph (1) shall be in effect for a period deter-
mined by the Secretary but not to exceed 18 months begin-
ning on the date the Secretary finds that the conditions
described in subparagraphs (A), (B), and (C) of paragraph
(1) exist. The Secretary shall terminate such denial—
(i) if the investigation with respect to which the
finding was made does not result in a criminal charge
against such person, if criminal charges have been
brought and the charges have been dismissed, or if a
judgment of acquittal has been entered, or
(ii) if the Secretary determines that such finding
was in error.
(B) EXTENSION.—If, at the end of the period described
in subparagraph (A), the Secretary determines that a per-
son has been criminally charged for an action described in
subparagraph (B) of paragraph (1), the Secretary may ex-
tend the period of denial of approval of an application for
a period not to exceed 18 months. The Secretary shall ter-
minate such extension if the charges have been dismissed,
if a judgment of acquittal has been entered, or if the Sec-
retary determines that the finding described in subpara-
graph (A) was in error.
(3) INFORMAL HEARING.—Within 10 days of the date an
order is issued under paragraph (1), the Secretary shall pro-
vide such person with an opportunity for an informal hearing,
to be held within such 10 days, on the decision of the Secretary
to refuse approval of an abbreviated drug application. Within
60 days of the date on which such hearing is held, the Sec-
retary shall notify the person given such hearing whether the
Secretary's refusal of approval will be continued, terminated,
or otherwise modified. Such notification shall be final agency
action.
(g) SUSPENSION AUTHORITY.—
(1) IN GENERAL.—If—
(A) the Secretary finds—
(i) that a person has engaged in conduct described
in subparagraph (B) of subsection (f)(l) in connection
with 2 or more drugs under abbreviated drug applica-
tions, or
(ii) that a person has engaged in flagrant and re-
peated, material violations of good manufacturing
practice or good laboratory practice in connection with
the development, manufacturing, or distribution of one
or more drugs approved under an abbreviated drug
application during a 2-year period, and—
(I) such violations may undermine the safety
and efficacy of such drugs, and
(II) the causes of such violations have not
been corrected within a reasonable period of time
-------
129 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 306
following notice of such violations by the Sec-
retary, and
(B) such person is under an active investigation by a
Federal authority in connection with a civil or criminal ac-
tion involving conduct described in subparagraph (A),
the Secretary shall issue an order suspending the distribution
of all drugs the development or approval of which was related
to such conduct described in subparagraph (A) or suspending
the distribution of all drugs approved under abbreviated drug
applications of such person if the Secretary finds that such
conduct may have affected the development or approval of a
significant number of drugs which the Secretary is unable to
identify. The Secretary shall exclude a drug from such order if
the Secretary determines that such conduct was not likely to
have influenced the safety or efficacy of such drug.
(2) PUBLIC HEALTH WAIVER.—The Secretary shall, on the
Secretary's own initiative or in response to a petition, waive
the suspension under paragraph (1) (involving an action de-
scribed in paragraph (l)(A)(i)) with respect to any drug if the
Secretary finds that such waiver is necessary to protect the
public health because sufficient quantities of the drug would
not otherwise be available. The Secretary shall act on any peti-
tion seeking action under this paragraph within 180 days of
the date the petition is submitted to the Secretary.
(h) TERMINATION OF SUSPENSION.—The Secretary shall with-
draw an order of suspension of the distribution of a drug under
subsection (g) if the person with respect to whom the order was is-
sued demonstrates in a petition to the Secretary—
(1)(A) on the basis of an audit by the Food and Drug Ad-
ministration or by experts acceptable to the Food and Drug Ad-
ministration, or on the basis of other information, that the de-
velopment, approval, manufacturing, and distribution of such
drug is in substantial compliance with the applicable require-
ments of this Act, and
(B) changes in ownership, management, or operations—
(i) fully remedy the patterns or practices with respect
to which the order was issued, and
(ii) provide reasonable assurances that such actions
will not occur in the future, or
(2) the initial determination was in error.
The Secretary shall act on a submission of a petition under this
subsection within 180 days of the date of its submission and the
Secretary may consider the petition concurrently with the suspen-
sion proceeding. Any information submitted to the Secretary under
this subsection does not constitute an amendment or supplement to
a pending or approved abbreviated drug application.
(i) PROCEDURE.—The Secretary may not take any action under
subsection (a), (b), (c), (d)(3), (g), or (h) with respect to any person
unless the Secretary has issued an order for such action made on
the record after opportunity for an agency hearing on disputed is-
sues of material fact. In the course of any investigation or hearing
under this subsection, the Secretary may administer oaths and af-
firmations, examine witnesses, receive evidence, and issue subpoe-
nas requiring the attendance and testimony of witnesses and the
-------
Sec. 306 FEDERAL FOOD, DRUB, AND COSMETIC ACT 130
production of evidence that relates to the matter under investiga-
tion.
(j) JUDICIAL REVIEW.—
(1) IN GENERAL.—Except as provided in paragraph (2), any
person that is the subject of an adverse decision under sub-
section (a), (b), (c), (d), (f), (g), or (h) may obtain a review of
such decision by the United States Court of Appeals for the
District of Columbia or for the circuit in which the person re-
sides, by filing in such court (within 60 days following the date
the person is notified of the Secretary's decision) a petition re-
questing that the decision be modified or set aside.
(2) EXCEPTION.—Any person that is the subject of an ad-
verse decision under clause (iii) or (iv) of subsection (b)(2)(B)
may obtain a review of such decision by the United States Dis-
trict Court for the District of Columbia or a district court of the
United States for the district in which the person resides, by
filing in such court (within 30 days following the date the per-
son is notified of the Secretary's decision) a complaint request-
ing that the decision be modified or set aside. In such an ac-
tion, the court shall determine the matter de novo.
(k) CERTIFICATION.—Any application for approval of a drug
product shall include—
(1) a certification that the applicant did not and will not
use in any capacity the services of any person debarred under
subsection (a) or (b), in connection with such application, and
(2) if such application is an abbreviated drug application,
a list of all convictions, described in subsections (a) and (b)
which occurred within the previous 5 years, of the applicant
and affiliated persons responsible for the development or sub-
mission of such application.
(1) APPLICABILITY.—
(1) CONVICTION.—For purposes of this section, a person is
considered to have been convicted of a criminal offense—
(A) when a judgment of conviction has been entered
against the person by a Federal or State court, regardless
of whether there is an appeal pending,
(B) when a plea of guilty or nolo contendere by the
person has been accepted by a Federal or State court, or
(C) when the person has entered into participation in
a first offender, deferred adjudication, or other similar ar-
rangement or program where judgment of conviction has
been withheld.
(2) EFFECTIVE DATES.—Subsection (a), subparagraph (A) of
subsection (b)(2), and clauses (i) and (ii) of subsection (b)(2)(B)
shall not apply to a conviction which occurred more than 5
years before the initiation of an agency action proposed to be
taken under subsection (a) or (b). Clauses (iii) and (iv) of sub-
section (b)(2)(B) and subsections (f) and (g) shall not apply to
an act or action which occurred more than 5 years before the
initiation of an agency action proposed to be taken under sub-
section (b), (f), or (g). Clause (iv) of subsection (b)(2)(B) shall
not apply to an action which occurred before June 1, 1992.
Subsection (k) shall not apply to applications submitted to the
Secretary before June 1, 1992.
-------
131 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 307
CIVIL PENALTIES
SEC. 307. [335b] (a) IN GENERAL.—Any person that the Sec-
retary finds—
(1) knowingly made or caused to be made, to any officer,
employee, or agent of the Department of Health and Human
Services, a false statement or misrepresentation of a material
fact in connection with an abbreviated drug application,
(2) bribed or attempted to bribe or paid or attempted to
pay an illegal gratuity to any officer, employee, or agent of the
Department of Health and Human Services in connection with
an abbreviated drug application,
(3) destroyed, altered, removed, or secreted, or procured
the destruction, alteration, removal, or secretion of, any mate-
rial document or other material evidence which was the prop-
erty of or in the possession of the Department of Health and
Human Services for the purpose of interfering with that De-
partment's discharge of its responsibilities in connection with
an abbreviated drug application,
(4) knowingly failed to disclose, to an officer or employee
of the Department of Health and Human Services, a material
fact which such person had an obligation to disclose relating to
any drug subject to an abbreviated drug application,
(5) knowingly obstructed an investigation of the Depart-
ment of Health and Human Services into any drug subject to
an abbreviated drug application,
(6) is a person that has an approved or pending drug prod-
uct application and has knowingly—
(A) employed or retained as a consultant or contractor,
or
(B) otherwise used in any capacity the services of,
a person who was debarred under section 306, or
(7) is an individual debarred under section 306 and, during
the period of debarment, provided services in any capacity to
a person that had an approved or pending drug product appli-
cation,
shall be liable to the United States for a civil penalty for each such
violation in an amount not to exceed $250,000 in the case of an in-
dividual and $1,000,000 in the case of any other person.
(b) PROCEDURE.—
(1) IN GENERAL.—
(A) ACTION BY THE SECRETARY.—A civil penalty under
subsection (a) shall be assessed by the Secretary on a per-
son by an order made on the record after an opportunity
for an agency hearing on disputed issues of material fact
and the amount of the penalty. In the course of any inves-
tigation or hearing under this subparagraph, the Secretary
may administer oaths and affirmations, examine wit-
nesses, receive evidence, and issue subpoenas requiring
the attendance and testimony of witnesses and the produc-
tion of evidence that relates to the matter under investiga-
tion.
(B) ACTION BY THE ATTORNEY GENERAL.—In lieu of a
proceeding under subparagraph (A), the Attorney General
-------
Sec. 308 FEDERAL FOOD, DRUB, AND COSMETIC ACT 132
may, upon request of the Secretary, institute a civil action
to recover a civil money penalty in the amount and for any
of the acts set forth in subsection (a). Such an action may
be instituted separately from or in connection with any
other claim, civil or criminal, initiated by the Attorney
General under this Act.
(2) AMOUNT.—In determining the amount of a civil penalty
under paragraph (1), the Secretary or the court shall take into
account the nature, circumstances, extent, and gravity of the
act subject to penalty, the person's ability to pay, the effect on
the person's ability to continue to do business, any history of
prior, similar acts, and such other matters as justice may re-
quire.
(3) LIMITATION ON ACTIONS.—No action may be initiated
under this section—
(A) with respect to any act described in subsection (a)
that occurred before the date of the enactment of this sec-
tion, or
(B) more than 6 years after the date when facts mate-
rial to the act are known or reasonably should have been
known by the Secretary but in no event more than 10
years after the date the act took place.
(c) JUDICIAL REVIEW.—Any person that is the subject of an ad-
verse decision under subsection (b)(l)(A) may obtain a review of
such decision by the United States Court of Appeals for the District
of Columbia or for the circuit in which the person resides, by filing
in such court (within 60 days following the date the person is noti-
fied of the Secretary's decision) a petition requesting that the deci-
sion be modified or set aside.
(d) RECOVERY OF PENALTIES.—The Attorney General may re-
cover any civil penalty (plus interest at the currently prevailing
rates from the date the penalty became final) assessed under sub-
section (b)(l)(A) in an action brought in the name of the United
States. The amount of such penalty may be deducted, when the
penalty has become final, from any sums then or later owing by the
United States to the person against whom the penalty has been as-
sessed. In an action brought under this subsection, the validity,
amount, and appropriateness of the penalty shall not be subject to
judicial review.
(e) INFORMANTS.—The Secretary may award to any individual
(other than an officer or employee of the Federal Government or a
person who materially participated in any conduct described in
subsection (a)) who provides information leading to the imposition
of a civil penalty under this section an amount not to exceed—
(1) $250,000, or
(2) one-half of the penalty so imposed and collected,
whichever is less. The decision of the Secretary on such award
shall not be reviewable.
AUTHORITY TO WITHDRAW APPROVAL OF ABBREVIATED DRUG
APPLICATIONS
SEC. 308. [335c] (a) IN GENERAL.—The Secretary—
(1) shall withdraw approval of an abbreviated drug appli-
cation if the Secretary finds that the approval was obtained,
-------
133 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 310
expedited, or otherwise facilitated through bribery, payment of
an illegal gratuity, or fraud or material false statement, and
(2) may withdraw approval of an abbreviated drug applica-
tion if the Secretary finds that the applicant has repeatedly
demonstrated a lack of ability to produce the drug for which
the application was submitted in accordance with the formula-
tions or manufacturing practice set forth in the abbreviated
drug application and has introduced, or attempted to intro-
duce, such adulterated or misbranded drug into commerce.
(b) PROCEDURE.—The Secretary may not take any action under
subsection (a) with respect to any person unless the Secretary has
issued an order for such action made on the record after oppor-
tunity for an agency hearing on disputed issues of material fact. In
the course of any investigation or hearing under this subsection,
the Secretary may administer oaths and affirmations, examine wit-
nesses, receive evidence, and issue subpoenas requiring the attend-
ance and testimony of witnesses and the production of evidence
that relates to the matter under investigation.
(c) APPLICABILITY.—Subsection (a) shall apply with respect to
offenses or acts regardless of when such offenses or acts occurred.
(d) JUDICIAL REVIEW.—Any person that is the subject of an ad-
verse decision under subsection (a) may obtain a review of such de-
cision by the United States Court of Appeals for the District of Co-
lumbia or for the circuit in which the person resides, by filing in
such court (within 60 days following the date the person is notified
of the Secretary's decision) a petition requesting that the decision
be modified or set aside.
REPORT OF MINOR VIOLATIONS
SEC. 309. [336] Nothing in this Act shall be construed as re-
quiring the Secretary to report for prosecution, or for the institu-
tion of libel or injunction proceedings, minor violations of this Act
whenever he believes that the public interest will be adequately
served by a suitable written notice or warning.
PROCEEDINGS IN NAME OF UNITED STATES; PROVISION AS TO
SUBPOENAS
SEC. 310. [337] (a) Except as provided in subsection (b), all
such proceedings for the enforcement, or to restrain violations, of
this Act shall be by and in the name of the United States. Subpoe-
nas for witnesses who are required to attend a court of the United
States, in any district, may run into any other district in any pro-
ceeding under this section.
(b)(l) A State may bring in its own name and within its juris-
diction proceedings for the civil enforcement, or to restrain viola-
tions, of section 401, 403(b), 403(c), 403(d), 403(e), 403(f), 403(g),
403(h), 403(i), 403(k), 403(q), or 403(r) if the food that is the subject
of the proceedings is located in the State.
(2) No proceeding may be commenced by a State under para-
graph (1)—
(A) before 30 days after the State has given notice to the
Secretary that the State intends to bring such proceeding,
-------
Sec. 310 FEDERAL FOOD. DRUG, AND COSMETIC ACT 134
(B) before 90 days after the State has given notice to the
Secretary of such intent if the Secretary has, within such 30
days, commenced an informal or formal enforcement action
pertaining to the food which would be the subject of such pro-
ceeding, or
(C) if the Secretary is diligently prosecuting a proceeding
in court pertaining to such food, has settled such proceeding,
or has settled the informal or formal enforcement action per-
taining to such food.
In any court proceeding described in subparagraph (C), a State
may intervene as a matter of right.
-------
CHAPTER IV—FOOD
DEFINITIONS AND STANDARDS FOR FOOD
SEC. 401. [341J Whenever in the judgment of the Secretary
such action will promote honesty and fair dealing in the interest
of consumers, he shall promulgate regulations fixing and establish-
ing for any food, under its common or usual name so far as prac-
ticable, a reasonable definition and standard of identity, a reason-
able standard of quality, or reasonable standards of fill of con-
tainer. No definition and standard of identity and no standard of
quality shall be established for fresh or dried fruits, fresh or dried
vegetables, or butter, except that definitions and standards of iden-
tity may be established for avocados, cantaloupes, citrus fruits, and
melons. In prescribing any standard of fill of container, the Sec-
retary shall give due consideration to the natural shrinkage in stor-
age and in transit of fresh natural food and to need for the nec-
essary packing and protective material. In the prescribing of any
standard of quality for any canned fruit or canned vegetable, con-
sideration shall be given and due allowance made for the differing
characteristics of the several varieties of such fruit or vegetable. In
prescribing a definition and standard of identity for any food or
class of food in which optional ingredients are permitted, the Sec-
retary shall, for the purpose of promoting honesty and fair dealing
in the interest of consumers, designate the optional ingredients
which shall be named on the label. Any definition and standard of
identity prescribed by the Secretary for avocados, cantaloupes, cit-
rus fruits, or melons shall relate only to maturity and to the effects
of freezing.
ADULTERATED FOOD
SEC. 402. [342] A food shall be deemed to be adulterated—
(a)1(l) If it bears or contains any poisonous or deleterious sub-
stance which may render it injurious to health; but in case the sub-
stance is not an added substance such food shall not be considered
adulterated under this clause if the quantity of such substance in
such food does not ordinarily render it injurious to health; or (2)(A)
if it bears or contains any added poisonous or added deleterious
substance (other than a substance that is a pesticide chemical resi-
due in or on a raw agricultural commodity or processed food, a food
additive, a color additive, or a new animal drug) that is unsafe
within the meaning of section 406; or (B) if it bears or contains a
pesticide chemical residue that is unsafe within the meaning of sec-
tion 408(a); or (C) if it is or if it bears or contains (i) any food addi-
tive that is unsafe within the meaning of section 409; or (ii) a new
1 The amendments made by section 3(i) of the "Nutrition Labeling and Education Act Amend-
ments of 1993" (P.L. 103-80) were based on incorrect form and consequently are not reflected.
135
-------
Sec. 402 FEDERAL FOOD, DRUG, AND COSMETIC ACT 136
animal drug (or conversion product thereof) that is unsafe within
the meaning of section 512; or (3) if it consists in whole or in part
of any filthy, putrid, or decomposed substance, or if it is otherwise
unfit for food; or (4) if it has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious to
health; or (5) if it is, in whole or in part, the product of a diseased
animal or of an animal which has died otherwise than by slaugh-
ter; or (6) if its container is composed, in whole or in part, of any
poisonous or deleterious substance which may render the contents
injurious to health; or (7) if it has been intentionally subjected to
radiation, unless the use of the radiation was in conformity with
a regulation or exemption in effect pursuant to section 409.
(b)(l) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or inferior-
ity has been concealed in any manner; or (4) if any substance has
been added thereto or mixed or packed therewith so as to increase
its bulk or weight, or reduce its quality or strength, or make it ap-
pear better or of greater value than it is.
(c) If it is, or it bears or contains, a color additive which is un-
safe within the meaning of section 721(a).
(d) If it is confectionery, and—
(1) has partially or completely imbedded therein any non-
nutritive object, except that this subparagraph shall not apply
in the case of any nonnutritive object if, in the judgment of the
Secretary as provided by regulations, such object is of practical
functional value to the confectionery product and would not
render the product injurious or hazardous to health;
(2) bears or contains any alcohol other than alcohol not in
excess of one-half of 1 per centum by volume derived solely
from the use of flavoring extracts, except that this clause shall
not apply to confectionery which is introduced or delivered for
introduction into, or received or held for sale in, interstate
commerce if the sale of such confectionery is permitted under
the laws of the State in which such confectionery is intended
to be offered for sale; or
(3) bears or contains any nonnutritive substance, except
that this subparagraph shall not apply to a safe nonnutritive
substance which is in or on confectionery by reason of its use
for some practical functional purpose in the manufacture, pack-
aging, or storage of such confectionery if the use of the sub-
stance does not promote deception of the consumer or other-
wise result in adulteration or misbranding in violation of any
provision of this Act, except that the Secretary may, for the
purpose of avoiding or resolving uncertainty as to the applica-
tion of this subparagraph, issue regulations allowing or prohib-
iting the use of particular nonnutritive substances.
(e) If it is oleomargarine or margarine or butter and any of the
raw material used therein consisted in whole or in part of any
filthy, putrid, or decomposed substance, or such oleomargarine or
margarine or butter is otherwise unfit for food.
(f)(l) If it is a dietary supplement or contains a dietary ingredi-
ent that—
-------
137 FEDERAL FOOD, DRU6, AND COSMETIC ACT Sec. 403
(A) presents a significant or unreasonable risk of illness or
injury under—
(i) conditions of use recommended or suggested in la-
beling, or
(ii) if no conditions of use are suggested or rec-
ommended in the labeling, under ordinary conditions of
use;
(B) is a new dietary ingredient for which there is inad-
equate information to provide reasonable assurance that such
ingredient does not present a significant or unreasonable risk
of illness or injury;
(C) the Secretary declares to pose an imminent hazard to
public health or safety, except that the authority to make such
declaration shall not be delegated and the Secretary shall
promptly after such a declaration initiate a proceeding in ac-
cordance with sections 554 and 556 of title 5, United States
Code, to affirm or withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it adul-
terated under paragraph (a)(l) under the conditions of use rec-
ommended or suggested in the labeling of such dietary supple-
ment.
In any proceeding under this subparagraph, the United States
shall bear the burden of proof on each element to show that a die-
tary supplement is adulterated. The court shall decide any issue
under this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney
a violation of paragraph (1)(A) for a civil proceeding, the person
against whom such proceeding would be initiated shall be given ap-
propriate notice and the opportunity to present views, orally and
in writing, at least 10 days before such notice, with regard to such
proceeding.
(g)(l) If it is a dietary supplement and it has been prepared,
packed, or held under conditions that do not meet current good
manufacturing practice regulations, including regulations requir-
ing, when necessary, expiration date labeling, issued by the Sec-
retary under subparagraph (2).
(2) The Secretary may by regulation prescribe good manufac-
turing practices for dietary supplements. Such regulations shall be
modeled after current good manufacturing practice regulations for
food and may not impose standards for which there is no current
and generally available analytical methodology. No standard of cur-
rent good manufacturing practice may be imposed unless such
standard is included in a regulation promulgated after notice and
opportunity for comment in accordance with chapter 5 of title 5,
United States Code.
MISBRANDED FOOD
SEC. 403. [343] A food shall be deemed to be misbranded—
(a) If (1) its labeling is false or misleading in any particular,
or (2) in the case of a food to which section 411 applies, its adver-
tising is false or misleading in a material respect or its labeling is
in violation of section 411(b)(2).
(b) If it is offered for sale under the name of another food.
-------
Sec. 403 FEDERAL FOOD, DRUG, AND COSMETIC ACT 138
(c) If it is an imitation of another food, unless its label bears,
in type of uniform size and prominence, the word "imitation" and,
immediately thereafter, the name of the food imitated.
(d) If its container is so made, formed, or filled as to be mis-
leading.
(e) If in package form unless it bears a label containing (1) the
name and place of business of the manufacturer, packer, or dis-
tributor; and (2) an accurate statement of the quantity of the con-
tents in terms of weight, measure, or numerical count, except that
under clause (2) of this paragraph reasonable variations shall be
permitted, and exemptions as to small packages shall be estab-
lished, by regulations prescribed by the Secretary.
(f) If 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 com-
pared with other words, statements, designs, or devices, in the la-
beling) and in such terms as to render it likely to be read and un-
derstood by the ordinary individual under customary conditions of
purchase and use.
(g) If it purports to be or is represented as a food for which a
definition and standard of identity has been prescribed by regula-
tions as provided by section 401, unless (1) it conforms to such defi-
nition and standard, and (2) its label bears the name of the food
specified in the definition and standard, and, insofar as may be re-
quired by such regulations, the common names of optional ingredi-
ents (other than spices, flavoring, and coloring) present in such
food.
(h) If it purports to be or is represented as—
(1) a food for which a standard of quality has been pre-
scribed by regulations as provided by section 401, and its qual-
ity falls below such standard, unless its label bears, in such
manner and form as such regulations specify, a statement that
it falls below such standard; or
(2) a food for which a standard or standards of fill of con-
tainer have been prescribed by regulations as provided by sec-
tion 401, and it falls below the standard of fill of container ap-
plicable thereto, unless its label bears, in such manner and
form as such regulations specify, a statement that it falls
below such standard.
(i) Unless its label bears (1) the common or usual name of the
food, if any there be, and (2) in case it is fabricated from two or
more ingredients, the common or usual name of each such ingredi-
ent and if the food purports to be a beverage containing vegetable
or fruit juice, a statement with appropriate prominence on the in-
formation panel of the total percentage of such fruit or vegetable
juice contained in the food; except that spices, flavorings, and colors
not required to be certified under section 721(c) unless sold as
spices, flavorings, or such colors, may be designated as spices,
flavorings, and colorings without naming each. To the extent that
compliance with the requirements of clause (2) of this paragraph
is impracticable, or results in deception or unfair competition, ex-
emptions shall be established by regulations promulgated by the
Secretary.
-------
139 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 403
(j) If it purports to be or is represented for special dietary uses,
unless its label bears such information concerning its vitamin, min-
eral, and other dietary properties as the Secretary determines to
be, and by regulations prescribes as, necessary in order fully to in-
form purchasers as to its value for such uses.
(k) If it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative, unless it bears labeling stating
that fact, except that to the extent that compliance with the re-
quirements of this paragraph is impracticable, exemptions shall be
established by regulations promulgated by the Secretary. The pro-
visions of this paragraph and paragraphs (g) and (i) with respect
to artificial coloring shall not apply in the case of butter, cheese,
or ice cream. The provisions of this paragraph with respect to
chemical preservatives shall not apply to a pesticide chemical when
used in or on a raw agricultural commodity which is the produce
of the soil.
(1) If it is a raw agricultural commodity which is the produce
of the soil, bearing or containing a pesticide chemical applied after
harvest, unless the shipping container of such commodity bears la-
beling which declares the presence of such chemical in or on such
commodity and the common or usual name and the function of
such chemical, except that no such declaration shall be required
while such commodity, having been removed from the shipping con-
tainer, is being held or displayed for sale at retail out of such con-
tainer in accordance with the custom of the trade.
(m) If it is a color additive, unless its packaging and labeling
are in conformity with such packaging and labeling requirements,
applicable to such color additive, as may be contained in regula-
tions issued under section 721.
(n) If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 3 or 4 of the Poison Preven-
tion Packaging Act of 1970.
(o)(l) If it contains saccharin, unless, except as provided in
subparagraph (2), its label and labeling bear the following state-
ment: "USE OF THIS PRODUCT MAY BE HAZARDOUS TO
YOUR HEALTH. THIS PRODUCT CONTAINS SACCHARIN
WHICH HAS BEEN DETERMINED TO CAUSE CANCER IN
LABORATORY ANIMALS". Such statement shall be located in a
conspicuous place on such label and labeling as proximate as pos-
sible to the name of such food and shall appear in conspicuous and
legible type in contrast by typography, layout, and color with other
printed matter on such label and labeling.
(2) The Secretary may by regulation review and revise or re-
move the requirement of subparagraph (1) if the Secretary deter-
mines such action is necessary to reflect the current state of knowl-
edge concerning saccharin.
[(p) Repealed by Pub. L. 104-124, April 1, 1996.]
(q)(l) Except as provided in subparagraphs (3), (4), and (5), if
it is a food intended for human consumption and is offered for sale,
unless its label or labeling bears nutrition information that pro-
vides—
(A)(i) the serving size which is an amount customarily
consumed and which is expressed in a common household
measure that is appropriate to the food, or
-------
Sec. 403 FEDERAL FOOD, DRUB, AND COSMETIC ACT 140
(ii) if the use of the food is not typically expressed in a
serving size, the common household unit of measure that ex-
presses the serving size of the food,
(B) the number of servings or other units of measure per
container,
(C) the total number of calories—
(i) derived from any source, and
(ii) derived from the total fat,
in each serving size or other unit of measure of the food,
(D) the amount of the following nutrients: Total fat, satu-
rated fat, cholesterol, sodium, total carbohydrates, complex car-
bohydrates, sugars, dietary fiber, and total protein contained in
each serving size or other unit of measure,
(E) any vitamin, mineral, or other nutrient required to be
placed on the label and labeling of food under this Act before
October 1, 1990, if the Secretary determines that such informa-
tion will assist consumers in maintaining healthy dietary prac-
tices.
The Secretary may by regulation require any information required
to be placed on the label or labeling by this subparagraph or sub-
paragraph (2)(A) to be highlighted on the label or labeling by larger
type, bold type, or contrasting color if the Secretary determines
that such highlighting will assist consumers in maintaining
healthy dietary practices.
(2)(A) If the Secretary determines that a nutrient other than
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should
be included in the label or labeling of food subject to subparagraph
(1) for purposes of providing information regarding the nutritional
value of such food that will assist consumers in maintaining
healthy dietary practices, the Secretary may by regulation require
that information relating to such additional nutrient be included in
the label or labeling of such food.
(B) If the Secretary determines that the information relating to
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or
clause (A) of this subparagraph to be included in the label or label-
ing of food is not necessary to assist consumers in maintaining
healthy dietary practices, the Secretary may by regulation remove
information relating to such nutrient from such requirement.
(3) For food that is received in bulk containers at a retail es-
tablishment, the Secretary may, by regulation, provide that the nu-
trition information required by subparagraphs (1) and (2) be dis-
played at the location in the retail establishment at which the food
is offered for sale.
(4)(A) The Secretary shall provide for furnishing the nutrition
information required by subparagraphs (1) and (2) with respect to
raw agricultural commodities and raw fish by issuing voluntary nu-
trition guidelines, as provided by clause (B) or by issuing regula-
tions that are mandatory as provided by clause (D).
(B)(i) Upon the expiration of 12 months after the date of the
enactment of the Nutrition Labeling and Education Act of 1990 *,
the Secretary, after providing an opportunity for comment, shall
issue guidelines for food retailers offering raw agricultural com-
lThe date is November 8, 1991.
-------
141 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 403
modities or raw fish to provide nutrition information specified in
subparagraphs (1) and (2). Such guidelines shall take into account
the actions taken by food retailers during such 12-month period to
provide to consumers nutrition information on raw agricultural
commodities and raw fish. Such guidelines shall only apply—
(I) in the case of raw agricultural commodities, to the 20
varieties of vegetables most frequently consumed during a year
and the 20 varieties of fruit most frequently consumed during
a year, and
(II) to the 20 varieties of raw fish most frequently
consumed during a year.
The vegetables, fruits, and raw fish to which such guidelines apply
shall be determined by the Secretary by regulation and the Sec-
retary may apply such guidelines regionally.
(ii) Upon the expiration of 12 months after the date of the en-
actment of the Nutrition Labeling and Education Act of 19901, the
Secretary shall issue a final regulation defining the circumstances
that constitute substantial compliance by food retailers with the
guidelines issued under subclause (i). The regulation shall provide
that there is not substantial compliance if a significant number of
retailers have failed to comply with the guidelines. The size of the
retailers and the portion of the market served by retailers in com-
pliance with the guidelines shall be considered in determining
whether the substantial-compliance standard has been met.
(C)(i) Upon the expiration of 30 months after the date of the
enactment of the Nutrition Labeling and Education Act of 19902,
the Secretary shall issue a report on actions taken by food retailers
to provide consumers with nutrition information for raw agricul-
tural commodities and raw fish under the guidelines issued under
clause (A). Such report shall include a determination of whether
there is substantial compliance with the guidelines.
(ii) If the Secretary finds that there is substantial compliance
with the guidelines, the Secretary shall issue a report and make a
determination of the type required in subclause (i) every two years.
(D)(i) If the Secretary determines that there is not substantial
compliance with the guidelines issued under clause (A), the Sec-
retary shall at the time such determination is made issue proposed
regulations requiring that any person who offers raw agricultural
commodities or raw fish to consumers provide, in a manner pre-
scribed by regulations, the nutrition information required by sub-
paragraphs (1) and (2). The Secretary shall issue final regulations
imposing such requirements 6 months after issuing the proposed
regulations. The final regulations shall become effective 6 months
after the date of their promulgation.
(ii) Regulations issued under subclause (i) may require that the
nutrition information required by subparagraphs (1) and (2) be pro-
vided for more than 20 varieties of vegetables, 20 varieties of fruit,
and 20 varieties of fish most frequently consumed during a year if
the Secretary finds that a larger number of such products are fre-
quently consumed. Such regulations shall permit such information
to be provided in a single location in each area in which raw agri-
1The date is November 8, 1991.
2 The date is May 8, 1993.
-------
Sec. 403 FEDERAL FOOD, DRUB, AND COSMETIC ACT 142
cultural commodities and raw fish are offered for sale. Such regula-
tions may provide that information shall be expressed as an aver-
age or range per serving of the same type of raw agricultural com-
modity or raw fish. The Secretary shall develop and make available
to the persons who offer such food to consumers the information re-
quired by subparagraphs (1) and (2).
(iii) Regulations issued under subclause (i) shall permit the re-
quired information to be provided in each area of an establishment
in which raw agricultural commodities and raw fish are offered for
sale. The regulations shall permit food retailers to display the re-
quired information by supplying copies of the information provided
by the Secretary, by making the information available in brochure,
notebook or leaflet form, or by posting a sign disclosing the infor-
mation. Such regulations shall also permit presentation of the re-
quired information to be supplemented by a video, live demonstra-
tion, or other media which the Secretary approves.
(E) For purposes of this subparagraph, the term "fish" includes
freshwater or marine fin fish, crustaceans, and mollusks, including
shellfish, amphibians, and other forms of aquatic animal life.
(F) No person who offers raw agricultural commodities or raw
fish to consumers may be prosecuted for minor violations of this
subparagraph if there has been substantial compliance with the re-
quirements of this paragraph.
(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to
food—
(i) which is served in restaurants or other establishments
in which food is served for immediate human consumption or
which is sold for sale or use in such establishments,
(ii) which is processed and prepared primarily in a retail
establishment, which is ready for human consumption, which
is of the type described in subclause (i), and which is offered
for sale to consumers but not for immediate human consump-
tion in such establishment and which is not offered for sale
outside such establishment,
(iii) which is an infant formula subject to section 412,
(iv) which is a medical food as defined in section 5(b) of the
Orphan Drug Act (21 U.S.C. 360ee(b)), or
(v) which is described in section 405(2).
(B) Subparagraphs (1) and (2) shall not apply to the label of
a food if the Secretary determines by regulations that compliance
with such subparagraphs is impracticable because the package of
such food is too small to comply with the requirements of such sub-
paragraphs and if the label of such food does not contain any nutri-
tion information.
(C) If a food contains insignificant amounts, as determined by
the Secretary, of all the nutrients required by subparagraphs (1)
and (2) to be listed in the label or labeling of food, the require-
ments of such subparagraphs shall not apply to such food if the
label, labeling, or advertising of such food does not make any claim
with respect to the nutritional value of such food. If a food contains
insignificant amounts, as determined by the Secretary, of more
than one-half the nutrients required by subparagraphs (1) and (2)
to be in the label or labeling of the food, the Secretary shall require
-------
143 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 403
the amounts of such nutrients to be stated in a. simplified form pre-
scribed by the Secretary.
(D) If a person offers food for sale and has annual gross sales
made or business done in sales to consumers which is not more
than $500,000 or has annual gross sales made or business done in
sales of food to consumers which is not more than $50,000, the re-
quirements of subparagraphs (1), (2), (3), and (4) shall not apply
with respect to food sold by such person to consumers unless the
label or labeling of food offered by such person provides nutrition
information or makes a nutrition claim.
(E)(i) During the 12-month period for which an exemption from
subparagraphs (1) and (2) is claimed pursuant to this subclause,
the requirements of such subparagraphs shall not apply to any food
product if—
(I) the labeling for such product does not provide nutrition
information or make a claim subject to paragraph (r),
(II) the person who claims for such product an exemption
from such subparagraphs employed fewer than an average of
100 full-time equivalent employees,
(III) such person provided the notice described in sub-
clause (iii), and
(IV) in the case of a food product which was sold in the 12-
month period preceding the period for which an exemption was
claimed, fewer than 100,000 units of such product were sold in
the United States during such preceding period, or in the case
of a food product which was not sold in the 12-month period
preceding the period for which such exemption is claimed,
fewer than 100,000 units of such product are reasonably antici-
pated to be sold in the United States during the period for
which such exemption is claimed.
(ii) During the 12-month period after the applicable date re-
ferred to in this sentence, the requirements of subparagraphs (1)
and (2) shall not apply to any food product which was first intro-
duced into interstate commerce before May 8, 1994, if the labeling
for such product does not provide nutrition information or make a
claim subject to paragraph (r), if such person provided the notice
described in subclause (iii), and if—
(I) during the 12-month period preceding May 8, 1994, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-
time equivalent employees and fewer than 600,000 units of
such product were sold in the United States,
(II) during the 12-month period preceding May 8, 1995, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-
time equivalent employees and fewer than 400,000 units of
such product were sold in the United States, or
(III) during the 12-month period preceding May 8, 1996,
the person who claims for such product an exemption from
such subparagraphs employed fewer than an average of 200
full-time equivalent employees and fewer than 200,000 units of
such product were sold in the United States.
(iii) The notice referred to in subclauses (i) and (ii) shall be
given to the Secretary prior to the beginning of the period during
-------
Sec. 403 FEDERAL FOOD, DRUG, AND COSMETIC ACT 144
which the exemption under subclause (i) or (ii) is to be in effect,
shall state that the person claiming such exemption for a food
product has complied with the applicable requirements of subclause
(i) or (ii), and shall—
(I) state the average number of full-time equivalent em-
ployees such person employed during the 12 months preceding
the date such person claims such exemption,
(II) state the approximate number of units the person
claiming the exemption sold in the United States,
(III) if the exemption is claimed for a food product which
was sold in the 12-month period preceding the period for which
the exemption was claimed, state the approximate number of
units of such product which were sold in the United States
during such preceding period, and, if the exemption is claimed
for a food product which was not sold in such preceding period,
state the number of units of such product which such person
reasonably anticipates will be sold in the United States during
the period for which the exemption was claimed, and
(IV) contain such information as the Secretary may require
to verify the information required by the preceding provisions
of this subclause if the Secretary has questioned the validity
of such information.
If a person is not an importer, has fewer than 10 full-time equiva-
lent employees, and sells fewer than 10,000 units of any food prod-
uct in any year, such person is not required to file a notice for such
product under this subclause for such year.
(iv) In the case of a person who claimed an exemption under
subclause (i) or (ii), if, during the period of such exemption, the
number of full-time equivalent employees of such person exceeds
the number in such subclause or if the number of food products
sold in the United States exceeds the number in such subclause,
such exemption shall extend to the expiration of 18 months after
the date the number of full-time equivalent employees or food prod-
ucts sold exceeded the applicable number.
(v) For any food product first introduced into interstate com-
merce after May 8, 2002, the Secretary may by regulation lower
the employee or units of food products requirement of subclause (i)
if the Secretary determines that the cost of compliance with such
lower requirement will not place an undue burden on persons sub-
ject to such lower requirement.
(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v)—
(I) the term "unit" means the packaging or, if there is no
packaging, the form in which a food product is offered for sale
to consumers,
(II) the term "food product" means food in any sized pack-
age which is manufactured by a single manufacturer or which
bears the same brand name, which bears the same statement
of identity, and which has similar preparation methods, and
(III) the term "person" in the case of a corporation includes
all domestic and foreign affiliates of the corporation.
(F) A dietary supplement product (including a food to which
section 411 applies) shall comply with the requirements of subpara-
graphs (1) and (2) in a manner which is appropriate for the product
-------
145 FEDERAL FOOD, DRUB. AND COSMETIC ACT Sec. 403
and which is specified in regulations of the Secretary which shall
provide that—
(i) nutrition information shall first list those dietary ingre-
dients that are present in the product in a significant amount
and for which a recommendation for daily consumption has
been established by the Secretary, except that a dietary ingre-
dient shall not be required to be listed if it is not present in
a significant amount, and shall list any other dietary ingredi-
ent present and identified as having no such recommendation;
(ii) the listing of dietary ingredients shall include the
quantity of each such ingredient (or of a proprietary blend of
such ingredients) per serving;
(iii) the listing of dietary ingredients may include the
source of a dietary ingredient; and
(iv) the nutrition information shall immediately precede
the ingredient information required under subclause (i), except
that no ingredient identified pursuant to subclause (i) shall be
required to be identified a second time.
(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food
which is sold by a food distributor if the food distributor principally
sells food to restaurants or other establishments in which food is
served for immediate human consumption and does not manufac-
ture, process, or repackage the food it sells.
(r)(l) Except as provided in clauses (A) through (C) of subpara-
graph (5), if it is a food intended for human consumption which is
offered for sale and for which a claim is made in the label or label-
ing of the food which expressly or by implication—
(A) characterizes the level of any nutrient which is of the
type required by paragraph (q)(l) or (q)(2) to be in the label or
labeling of the food unless the claim is made in accordance
with subparagraph (2), or
(B) characterizes the relationship of any nutrient which is
of the type required by paragraph (q)(l) or (q)(2) to be in the
label or labeling of the food to a disease or a health-related
condition unless the claim is made in accordance with subpara-
graph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears as
part of the nutrition information required or permitted by such
paragraph is not a claim which is subject to this paragraph and a
claim subject to clause (A) is not subject to clause (B).
(2)(A) Except as provided in subparagraphs (4)(A)(ii) and
(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a claim
described in subparagraph (1)(A)—
(i) may be made only if the characterization of the level
made in the claim uses terms which are defined in regulations
of the Secretary,
(ii) may not state the absence of a nutrient unless—
(I) the nutrient is usually present in the food or in a
food which substitutes for the food as defined by the Sec-
retary by regulation, or
(II) the Secretary by regulation permits such a state-
ment on the basis of a finding that such a statement would
assist consumers in maintaining healthy dietary practices
-------
Sec. 403 FEDERAL FOOD, DRUG, AND COSMETIC ACT 146
and the statement discloses that the nutrient is not usu-
ally present in the food,
(iii) may not be made with respect to the level of choles-
terol in the food if the food contains, as determined by the Sec-
retary by regulation, fat or saturated fat in an amount which
increases to persons in the general population the risk of dis-
ease or a health related condition which is diet related un-
less—
(I) the Secretary finds by regulation that the level of
cholesterol is substantially less than the level usually
Eresent in the food or in a food which substitutes for the
)od and which has a significant market share, or the Sec-
retary by regulation permits a statement regarding the ab-
sence of cholesterol on the basis of a finding that choles-
terol is not usually present in the food and that such a
statement would assist consumers in maintaining healthy
dietary practices and a requirement that the statement
disclose that cholesterol is not usually present in the food,
and
(II) the label or labeling of the food discloses the level
of such fat or saturated fat in immediate proximity to such
claim and with appropriate prominence which shall be no
less than one-half the size of the claim with respect to the
level of cholesterol,
(iv) may not be made with respect to the level of saturated
fat in the food if the food contains cholesterol unless the label
or labeling of the food discloses the level of cholesterol in the
food in immediate proximity to such claim and with appro-
priate prominence which shall be no less than one-half the size
of the claim with respect to the level of saturated fat,
(v) may not state that a food is high in dietary fiber unless
the food is low in total fat as defined by the Secretary or the
label or labeling discloses the level of total fat in the food in
immediate proximity to such statement and with appropriate
prominence which shall be no less than one-half the size of the
claim with respect to the level of dietary fiber, and
(vi) may not be made if the Secretary by regulation pro-
hibits the claim because the claim is misleading in light of the
level of another nutrient in the food.
(B) If a claim described in subparagraph (1)(A) is made with
respect to a nutrient in a food, the label or labeling of such food
shall contain, prominently and in immediate proximity to such
claim, the following statement: "See for nutrition in-
formation." In the statement—
(i) the blank shall identify the panel on which the informa-
tion described in the statement may be found, and
(ii) if the Secretary determines that the food contains a nu-
trient at a level which increases to persons in the general pop-
ulation the risk of a disease or health-related condition which
is diet related, taking into account the significance of the food
in the total daily diet, the statement shall also identify such
nutrient.
(C) Subparagraph (2)(A) does not apply to a claim described in
subparagraph (1)(A) and contained in the label or labeling of a food
-------
147 FEDERAL FOOD, DRUG. AND COSMETIC ACT Sec. 403
if such claim is contained in the brand name of such food and such
brand name was in use on such food before October 25, 1989, un-
less the brand name contains a term defined by the Secretary
under subparagraph (2)(A)(i). Such a claim is subject to paragraph
(a).
(D) Subparagraph (2) does not apply to a claim described in
subparagraph (1)(A) which uses the term "diet" and is contained in
the label or labeling of a soft drink if (i) such claim is contained
in the brand name of such soft drink, (ii) such brand name was in
use on such soft drink before October 25, 1989, and (iii) the use of
the term "diet" was in conformity with section 105.66 of title 21 of
the Code of Federal Regulations. Such a claim is subject to para-
graph (a).
(E) Subclauses (i) through (v) of subparagraph (2)(A) do not
apply to a statement in the label or labeling of food which describes
the percentage of vitamins and minerals in the food in relation to
the amount of such vitamins and minerals recommended for daily
consumption by the Secretary.
(F) Subclause (i) clause (A) does not apply to a statement in
the labeling of a dietary supplement that characterizes the percent-
age level of a dietary ingredient for which the Secretary has not es-
tablished a reference daily intake, daily recommended value, or
other recommendation for daily consumption.
(3)(A) Except as provided in subparagraph (5), a claim de-
scribed in subparagraph (1)(B) may only be made—
(i) if the claim meets the requirements of the regulations
of the Secretary promulgated under clause (B), and
(ii) if the food for which the claim is made does not con-
tain, as determined by the Secretary by regulation, any nutri-
ent in an amount which increases to persons in the general
population the risk of a disease or health-related condition
which is diet related, taking into account the significance of
the food in the total daily diet, except that the Secretary may
by regulation permit such a claim based on a finding that such
a claim would assist consumers in maintaining healthy dietary
practices and based on a requirement that the label contain a
disclosure of the type required by subparagraph (2)(B).
(B)(i) The Secretary shall promulgate regulations authorizing
claims of the type described in subparagraph (1)(B) only if the Sec-
retary determines, based on the totality of publicly available sci-
entific evidence (including evidence from well-designed studies con-
ducted in a manner which is consistent with generally recognized
scientific procedures and principles), that there is significant sci-
entific agreement, among experts qualified by scientific training
and experience to evaluate such claims, that the claim is supported
by such evidence.
(ii) A regulation described in subclause (i) shall describe—
(I) the relationship between a nutrient of the type required
in the label or labeling of food by paragraph (q)(l) or (q)(2) and
a disease or health-related condition, and
(II) the significance of each such nutrient in affecting such
disease or health-related condition.
(iii) A regulation described in subclause (i) shall require such
claim to be stated in a manner so that the claim is an accurate rep-
-------
Sec. 403 FEDERAL FOOD. DRUG. AND COSMETIC ACT 148
resentation of the matters set out in subclause (ii) and so that the
claim enables the public to comprehend the information provided in
the claim and to understand the relative significance of such infor-
mation in the context of a total daily diet.
(4)(A)(i) Any person may petition the Secretary to issue a regu-
lation under subparagraph (2)(A)(i) or (3)(B) relating to a claim de-
scribed in subparagraph (1)(A) or (1)(B). Not later than 100 days
after the petition is received by the Secretary, the Secretary shall
issue a final decision denying the petition or file the petition for
further action by the Secretary. If the Secretary denies the petition,
the petition shall not be made available to the public. If the Sec-
retary files the petition, the Secretary shall deny the petition or
issue a proposed regulation to take the action requested in the peti-
tion not later than 90 days after the date of such decision.
(ii) Any person may petition the Secretary for permission to
use in a claim described in subparagraph (1)(A) terms that are con-
sistent with the terms defined by the Secretary under subpara-
graph (2)(A)(i). Within 90 days of the submission of such a petition,
the Secretary shall issue a final decision denying the petition or
granting such permission.
(iii) Any person may petition the Secretary for permission to
use an implied claim described in subparagraph (1)(A) in a brand
name. After publishing notice of an opportunity to comment on the
petition in the Federal Register and making the petition available
to the public, the Secretary shall grant the petition if the Secretary
finds that such claim is not misleading and is consistent with
terms defined by the Secretary under subparagraph (2)(A)(i). The
Secretary shall grant or deny the petition within 100 days of the
date it is submitted to the Secretary and the petition shall be con-
sidered granted if the Secretary does not act on it within such 100
days.
(B) A petition under clause (A)(i) respecting a claim described
in subparagraph (1)(A) or (1)(B) shall include an explanation of the
reasons why the claim meets the requirements of this paragraph
and a summary of the scientific data which supports such reasons.
(C) If a petition for a regulation under subparagraph (3)(B) re-
lies on a report from an authoritative scientific body of the United
States, the Secretary shall consider such report and shall justify
any decision rejecting the conclusions of such report.
(5)(A) This paragraph does not apply to infant formulas subject
to section 412(h) and medical foods as defined in section 5(b) of the
Orphan Drug Act.
(B) Subclauses (iii) through (v) of subparagraph (2)(A) and sub-
paragraph (2)(B) do not apply to food which is served in res-
taurants or other establishments in which food is served for imme-
diate human consumption or which is sold for sale or use in such
establishments.
(C) A subparagraph (1)(A) claim made with respect to a food
which claim is required by a standard of identity issued under sec-
tion 401 shall not be subject to subparagraph (2)(A)(i) or (2)(B).
(D) A subparagraph (1)(B) claim made with respect to a dietary
supplement of vitamins, minerals, herbs, or other similar nutri-
tional substances shall not be subject to subparagraph (3) but shall
-------
149 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 403
be subject to a procedure and standard, respecting the validity of
such claim, established by regulation of the Secretary.
(6) For purposes of paragraph (r)(l)(B), a statement for a die-
tary supplement may be made if—
(A) the statement claims a benefit related to a classical nu-
trient deficiency disease and discloses the prevalence of such
disease in the United States, describes the role of a nutrient
or dietary ingredient intended to affect the structure or func-
tion in humans, characterizes the documented mechanism by
which a nutrient or dietary ingredient acts to maintain such
structure or function, or describes general well-being from con-
sumption of a nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has sub-
stantiation that such statement is truthful and not misleading,
and
(C) the statement contains, prominently displayed and in
boldface type, the following: 'This statement has not been eval-
uated by the Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent any disease.".
A statement under this subparagraph may not claim to diagnose,
mitigate, treat, cure, or prevent a specific disease or class of dis-
eases. If the manufacturer of a dietary supplement proposes to
make a statement described in the first sentence of this subpara-
graph in the labeling of the dietary supplement, the manufacturer
shall notify the Secretary no later than 30 days after the first mar-
keting of the dietary supplement with such statement that such a
statement is being made.
(s) If—
(1) it is a dietary supplement; and
(2)(A) the label or labeling of the supplement fails to list—
(i) the name of each ingredient of the supplement that
is described in section 201(ff); and
(ii)(I) the quantity of each such ingredient; or
(II) with respect to a proprietary blend of such ingredi-
ents, the total quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement fails to
identify the product by using the term "dietary supplement",
which term may be modified with the name of such an ingredi-
ent;
(C) the supplement contains an ingredient described in
section 201(ff)(l)(C), and the label or labeling of the supple-
ment fails to identify any part of the plant from which the in-
gredient is derived;
(D) the supplement—
(i) is covered by the specifications of an official com-
pendium;
(ii) is represented as conforming to the specifications
of an official compendium; and
(iii) fails to so conform; or
(E) the supplement—
(i) is not covered by the specifications of an official
compendium; and
(ii)(I) fails to have the identity and strength that the
supplement is represented to have; or
-------
Sec. 403A FEDERAL FOOD. DRUG. AND COSMETIC ACT 150
(II) fails to meet the quality (including tablet or cap-
sule disintegration), purity, or compositional specifications,
based on validated assay or other appropriate methods,
that the supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely be-
cause its label or labeling contains directions or conditions of use
or warnings.
SEC. 403A. [343—1] (a) Except as provided in subsection (b), no
State or political subdivision of a State may directly or indirectly
establish under any authority or continue in effect as to any food
in interstate commerce—
(1) any requirement for a food which is the subject of a
standard of identity established under section 401 that is not
identical to such standard of identity or that is not identical to
the requirement of section 403(g), except that this paragraph
does not apply to a standard of identity of a State or political
subdivision of a State for maple syrup that is of the type re-
quired by sections 401 and 403(g),
(2) any requirement for the labeling of food of the type re-
quired by section 403(c), 403(e), or 403(i)(2) that is not iden-
tical to the requirement of such section, except that this para-
graph does not apply to a requirement of a State or political
subdivision of a State that is of the type required by section
403(c) and that is applicable to maple syrup,
(3) any requirement for the labeling of food of the type re-
quired by section 403(b), 403(d), 403(f>, 403(h), 403(i)(l), or
403(k) that is not identical to the requirement of such section,
except that this paragraph does not apply to a requirement of
a State or political subdivision of a State that is of the type re-
quired by section 403(h)(l) and that is applicable to maple
syrup,
(4) any requirement for nutrition labeling of food that is
not identical to the requirement of section 403(q), except a re-
quirement for nutrition labeling of food which is exempt under
subclause (i) or (ii) of section 403(q)(5)(A), or
(5) any requirement respecting any claim of the type de-
scribed in section 403(r)(l) made in the label or labeling of food
that is not identical to the requirement of section 403(r), except
a requirement respecting a claim made in the label or labeling
of food which is exempt under section 403(r)(5)(B).
Paragraph (3) shall take effect in accordance with section 6(b) of
the Nutrition Labeling and Education Act of 1990.
(b) Upon petition of a State or a political subdivision of a State,
the Secretary may exempt from subsection (a), under such condi-
tions as may be prescribed by regulation, any State or local re-
quirement that—
(1) would not cause any food to be in violation of any appli-
cable requirement under Federal law,
(2) would not unduly burden interstate commerce, and
(3) is designed to address a particular need for information
which need is not met by the requirements of the sections re-
ferred to in subsection (a).
-------
151 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 404
DIETAEY SUPPLEMENT LABELING EXEMPTIONS
SEC. 403B. f 343-2J (a) IN GENERAL.—A publication, including
an article, a chapter in a book, or an official abstract of a peer-re-
viewed scientific publication that appears in an article and was
prepared by the author or the editors of the publication, which is
reprinted in its entirety, shall not be defined as labeling when used
in connection with the sale of a dietary supplement to consumers
when it—
(1) is not false or misleading;
(2) does not promote a particular manufacturer or brand of
a dietary supplement;
(3) is displayed or presented, or is displayed or presented
with other such items on the same subject matter, so as to
present a balanced view of the available scientific information
on a dietary supplement;
(4) if displayed in an establishment, is physically separate
from the dietary supplements; and
(5) does not have appended to it any information by sticker
or any other method.
(b) APPLICATION.—Subsection (a) shall not apply to or restrict
a retailer or wholesaler of dietary supplements in any way whatso-
ever in the sale of books or other publications as a part of the busi-
ness of such retailer or wholesaler.
(c) BURDEN OF PROOF.—In any proceeding brought under sub-
section (a), the burden of proof shall be on the United States to es-
tablish that an article or other such matter is false or misleading.
EMERGENCY PERMIT CONTROL
SEC. 404. [344] (a) Whenever the Secretary finds after inves-
tigation that the distribution in interstate commerce of any class
of food may, by reason of contamination with micro-organisms dur-
ing the manufacture, processing, or packing thereof in any locality,
be injurious to health, and that such injurious nature cannot be
adequately determined after such articles have entered interstate
commerce, he then, and in such case only, shall promulgate regula-
tions providing for the issuance, to manufacturers, processors, or
packers of such class of food in such locality of permits to which
shall be attached such conditions governing the manufacture, proc-
essing, or packaging of such class of food, for such temporary pe-
riod of time, as may be necessary to protect the public health; and
after the effective date of such regulations, and during such tem-
porary period, no person shall introduce or deliver for introduction
into interstate commerce any such food manufactured, processed,
or packed by any such manufacturer, processor, or packer unless
such manufacturer, processor, or packer holds a permit issued by
the Secretary as provided by such regulations.
(b) The Secretary is authorized to suspend immediately upon
notice any permit issued under authority of this section if it is
found that any of the conditions of the permit have been violated.
The holder of a permit so suspended shall be privileged at any time
to apply for the reinstatement of such permit, and the Secretary
shall, immediately after prompt hearing and an inspection of the
establishment, reinstate such permit if it is found that adequate
-------
Sec. 405 FEDERAL FOOD. DRUG, AND COSMETIC ACT 152
measures have been taken to comply with and maintain the condi-
tions of the permit, as originally issued or as amended.
(c) Any officer or employee duly designated by the Secretary
shall have access to any factory or establishment, the operator of
which holds a permit from the Secretary, for the purpose of
ascertaining whether or not the conditions of the permit are being
complied with, and denial of access for such inspection shall be
ground for suspension of the permit until such access is freely
given by the operator.
REGULATIONS MAKING EXEMPTIONS
SEC. 405. [3451 The Secretary shall promulgate regulations
exempting from any labeling requirement of this Act (1) small open
containers of fresh fruits and fresh vegetables and (2) food which
is in accordance with the practice of the trade, to be processed, la-
beled, or repacked in substantial quantities at establishments other
than those where originally processed or packed, or condition that
such food is not adulterated or misbranded under the provisions of
this Act upon removal from such processing, labeling, or repacking
establishment. This section does not apply to the labeling require-
ments of sections 403(q) and 403(r).
TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD
SEC. 406. [346] Any poisonous or deleterious substance added
to any food, except where such substance is required in the produc-
tion thereof or cannot be avoided by good manufacturing practice
shall be deemed to be unsafe for purposes of the application of
clause (2)(A) of section 402(a); but when such substance is so re-
quired or cannot be so avoided, the Secretary shall promulgate reg-
ulations limiting the quantity therein or thereon to such extent as
he finds necessary for the protection of public health, and any
quantity exceeding the limits so fixed shall also be deemed to be
unsafe for purposes of the application of clause (2)(A) of section
402(a). While such a regulation is in effect limiting the quantity of
any such substance in the case of any food, such food shall not, by
reason of bearing or containing any added amount of such sub-
stance, be considered to be adulterated within the meaning of
clause (1) of section 402(a). In determining the quantity of such
added substance to be tolerated in or on different articles of food
the Secretary shall take into account the extent to which the use
of such substance is required or cannot be avoided in the produc-
tion of each such article, and the other ways in which the consumer
may be affected by the same or other poisonous or deleterious sub-
stances.
OLEOMARGARINE OR MARGARINE
SEC. 407. [347]l (a) Colored oleomargarine or colored mar-
garine which is sold in the same State or Territory in which it is
'Public Law 81-459, March 16, 1950 (64 Stat. 20), amended section 15 of the Federal Trade
Commission Act by adding the following subsection:
"(0 For the purposes of this section and section 407 of the Federal Food, Drug, and Cosmetic
Act, as amended, the term 'oleomargarine' or "margarine' includes—
"(1) all substances, mixtures, and compounds known as oleomargarine or margarine;
-------
153 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 407
produced shall be subject in the same manner and to the same ex-
tent to the provisions of this Act as if it had been introduced in
interstate commerce.
(b) No person shall sell, or offer for sale, colored oleomargarine
or colored margarine unless-j-
(1) such oleomargarine or margarine is packaged,
(2) the net weight of the contents of any package sold in
a retail establishment is one pound or less,
(3) there appears on the label of the package (A) the word
"oleomargarine" or "margarine" in type or lettering at least as
large as any other type or lettering on such label, and (B) a
full and accurate statement of all the ingredients contained in
such oleomargarine, or margarine, and
(4) each part of the contents of the package is contained
in a wrapper which bears the word "oleomargarine" or "mar-
garine" in type or lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not
in lieu of any of the other requirements of this Act.
(c) No person shall possess in a form ready for serving colored
oleomargarine or colored margarine at a public eating place unless
a notice that oleomargarine or margarine is served is displayed
prominently and conspicuously in such place and in such manner
as to render it likely to be read and understood by the ordinary in-
dividual being served in such eating place or is printed or is other-
wise set forth on the menu in type or lettering not smaller than
that normally used to designate the serving of other food items. No
person shall serve colored oleomargarine or colored margarine at a
public eating place, whether or not any charge is made therefor,
unless (1) each separate serving bears or is accompanied by label-
ing identifying it as oleomargarine or margarine, or (2) each sepa-
rate serving thereof is triangular in shape.
(d) Colored oleomargarine or colored margarine when served
with meals at a public eating place shall at the time of such service
be exempt from the labeling requirements of section 403 (except (a)
and 403 (f))1 if it complies with the requirements of subsection (b)
of this section.
(e) For the purpose of this section colored oleomargarine or col-
ored margarine is oleomargarine or margarine having a tint or
shade containing more than one and six-tenths degrees of yellow,
or of yellow and red collectively, but with an excess of yellow over
red, measured in terms of Lovibond tintometer scale or its equiva-
lent.
"(2) all substances, mixtures, and compounds which have a consistence similar to that of
butter and which contain any edible oils or fats other than milk fat if made in imitation
or semblance of butter."
In repealing section 2301 of the Internal Revenue Code (relating to the tax on oleomargarine)
Public Law 81-^59 declared, in part: The Congress hereby finds and declares that the sale,
or the serving in public eating places, of colored oleomargarine or colored margarine without
clear identification as such or which is otherwise adulterated or misbranded within the meaning
of the Federal Food, Drug, and Cosmetic Act depresses the market in interstate commerce for
butter and for oleomargarine or margarine clearly identified and neither adulterated nor mis-
branded, and constitutes a burden on interstate commerce in such articles. Such burden exists,
irrespective of whether such oleomargarine or margarine originates from an interstate source
or from the State in which it is sold."
Sec. 6 of Public Law 81-459 states that "nothing in this Act shall be construed as authorizing
the possession, sale, or serving of colored oleomargarine or colored margarine in any State or
Territory in contravention of the laws of such State or Territory."
1 Probably should be "(except paragraphs (a) and (f))".
-------
Sec. 408 FEDERAL FOOD, DRUG, AND COSMETIC ACT 154
TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
SEC. 408. [6a] (a) REQUIREMENT FOR TOLERANCE OR EXEMP-
TION.—
(1) GENERAL RULE.—Except as provided in paragraph (2)
or (3), any pesticide chemical residue in or on a food shall be
deemed unsafe for the purpose of section 402(a)(2)(B) unless—
(A) a tolerance for such pesticide chemical residue in
or on such food is in effect under this section and the
quantity of the residue is within the limits of the toler-
ance; or
(B) an exemption from the requirement of a tolerance
is in effect under this section for the pesticide chemical
residue.
For the purposes of this section, the term "food", when used as
a noun without modification, shall mean a raw agricultural
commodity or processed food.
(2) PROCESSED FOOD.—Notwithstanding paragraph (1)—
(A) if a tolerance is in effect under this section for a
pesticide chemical residue in or on a raw agricultural com-
modity, a pesticide chemical residue that is present in or
on a processed food because the food is made from that
raw agricultural commodity shall not be considered unsafe
within the meaning of section 402(a)(2)(B) despite the lack
of a tolerance for the pesticide chemical residue in or on
the processed food if the pesticide chemical has been used
in or on the raw agricultural commodity in conformity with
a tolerance under this section, such residue in or on the
raw agricultural commodity has been removed to the ex-
tent possible in good manufacturing practice, and the con-
centration of the pesticide chemical residue in the proc-
essed food is not greater than the tolerance prescribed for
the pesticide chemical residue in the raw agricultural com-
modity; or
(B) if an exemption for the requirement for a tolerance
is in effect under this section for a pesticide chemical resi-
due in or on a raw agricultural commodity, a pesticide
chemical residue that is present in or on a processed food
because the food is made from that raw agricultural com-
modity shall not be considered unsafe within the meaning
of section 402(a)(2)(B).
(3) RESIDUES OF DEGRADATION PRODUCTS.—If a pesticide
chemical residue is present in or on a food because it is a
metabolite or other degradation product of a precursor sub-
stance that itself is a pesticide chemical or pesticide chemical
residue, such a residue shall not be considered to be unsafe
within the meaning of section 402(a)(2)(B) despite the lack of
a tolerance or exemption from the need for a tolerance for such
residue in or on such food if—
(A) the Administrator has not determined that the
degradation product is likely to pose any potential health
risk from dietary exposure that is of a different type than,
or of a greater significance than, any risk posed by dietary
exposure to the precursor substance;
-------
155 FEDERAL FOOD, DRUG, AND COSMETIC ACT Sec. 408
(B) either—
(i) a tolerance is in effect under this section for
residues of the precursor substance in or on the food,
and the combined level of residues of the degradation
product and the precursor substance in or on the food
is at or below the stoichiometrically equivalent level
that would be permitted by the tolerance if the residue
consisted only of the precursor substance rather than
the degradation product; or
(ii) an exemption from the need for a tolerance is
in effect under this section for residues of the precur-
sor substance in or on the food; and
(C) the tolerance or exemption for residues of the pre-
cursor substance does not state that it applies only to par-
ticular named substances and does not state that it does
not apply to residues of the degradation product.
(4) EFFECT OF TOLERANCE OR EXEMPTION.—While a toler-
ance or exemption from the requirement for a tolerance is in
effect under this section for a pesticide chemical residue with
respect to any food, the food shall not by reason of bearing or
containing any amount of such a residue be considered to be
adulterated within the meaning of section 402(a)(l).
(b) AUTHORITY AND STANDARD FOR TOLERANCE.—
(1) AUTHORITY.—The Administrator may issue regulations
establishing, modifying, or revoking a tolerance for a pesticide
chemical residue in or on a food—
(A) in response to a petition filed under subsection (d);
or
(B) on the Administrator's own initiative under sub-
section (e).
As used in this section, the term "modify" shall not mean ex-
panding the tolerance to cover additional foods.
(2) STANDARD.—
(A) GENERAL RULE.—
(i) STANDARD.—The Administrator may establish
or leave in effect a tolerance for a pesticide chemical
residue in or on a food only if the Administrator deter-
mines that the tolerance is safe. The Administrator
shall modify or revoke a tolerance if the Administrator
determines it is not safe.
(ii) DETERMINATION OF SAFETY.—As used in this
section, the term "safe", with respect to a tolerance for
a pesticide chemical residue, means that the Adminis-
trator has determined that there is a reasonable cer-
tainty that no harm will result from aggregate expo-
sure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures
for which there is reliable information.
(iii) RULE OF CONSTRUCTION.—With respect to a
tolerance, a pesticide chemical residue meeting the
standard under clause (i) is not an eligible pesticide
chemical residue for purposes of subparagraph (B).
(B) TOLERANCES FOR ELIGIBLE PESTICIDE CHEMICAL
RESIDUES.—
-------
Sec. 408 FEDERAL FOOD, DRUB. AND COSMETIC ACT 156
(i) DEFINITION.—As used in this subparagraph,
the term "eligible pesticide chemical residue" means a
pesticide chemical residue as to which—
(I) the Administrator is not able to identify a
level of exposure to the residue at which the resi-
due will not cause or contribute to a known or an-
ticipated harm to human health (referred to in
this section as a "nonthreshold effect");
(II) the lifetime risk of experiencing the non-
threshold effect is appropriately assessed by quan-
titative risk assessment; and
(III) with regard to any known or anticipated
harm to human health for which the Adminis-
trator is able to identify a level at which the resi-
due will not cause such harm (referred to in this
section as a "threshold effect"), the Administrator
determines that the level of aggregate exposure is
safe.
(ii) DETERMINATION OF TOLERANCE.—Notwith-
standing subparagraph (A)(i), a tolerance for an eligi-
ble pesticide chemical residue may be left in effect or
modified under this subparagraph if—
(I) at least one of the conditions described in
clause (iii) is met; and
(II) both of the conditions described in clause
(iv) are met.
(iii) CONDITIONS REGARDING USE.—For purposes of
clause (ii), the conditions described in this clause with
respect to a tolerance for an eligible pesticide chemical
residue are the following:
(I) Use of the pesticide chemical that produces
the residue protects consumers from adverse ef-
fects on health that would pose a greater risk
than the dietary risk from the residue.
(II) Use of the pesticide chemical that pro-
duces the residue is necessary to avoid a signifi-
cant disruption in domestic production of an ade-
quate, wholesome, and economical food supply.
(iv) CONDITIONS REGARDING RISK.—For purposes of
clause (ii), the conditions described in this clause with
respect to a tolerance for an eligible pesticide chemical
residue are the following:
(I) The yearly risk associated with the non-
threshold effect from aggregate exposure to the
residue does not exceed 10 times the yearly risk
that would be allowed under subparagraph (A) for
such effect.
(II) The tolerance is limited so as to ensure
that the risk over a lifetime associated with the
nonthreshold effect from aggregate exposure to
the residue is not greater than twice the lifetime
risk that would be allowed under subparagraph
(A) for such effect.
-------
157 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 408
(v) REVIEW.—Five years after the date on which
the Administrator makes a determination to leave in
effect or modify a tolerance under this subparagraph,
and thereafter as the Administrator deems appro-
priate, the Administrator shall determine, after notice
and opportunity for comment, whether it has been
demonstrated to the Administrator that a condition
described in clause (iii)(I) or clause (iii)(II) continues to
exist with respect to the tolerance and that the yearly
and lifetime risks from aggregate exposure to such
residue continue to comply with the limits specified in
clause (iv). If the Administrator determines by such
date that such demonstration has not been made, the
Administrator shall, not later than 180 days after the
date of such determination, issue a regulation under
subsection (e)(l) to modify or revoke the tolerance.
(vi) INFANTS AND CHILDREN.—Any tolerance under
this subparagraph shall meet the requirements of sub-
paragraph (C).
(C) EXPOSURE OF INFANTS AND CHILDREN.—In estab-
lishing, modifying, leaving in effect, or revoking a toler-
ance or exemption for a pesticide chemical residue, the Ad-
ministrator—
(i) shall assess the risk of the pesticide chemical
residue based on—
(I) available information about consumption
patterns among infants and children that are like-
ly to result in disproportionately high consump-
tion of foods containing or bearing such residue
among infants and children in comparison to the
general population;
(II) available information concerning the spe-
cial susceptibility of infants and children to the
pesticide chemical residues, including neurological
differences between infants and children and
adults, and effects of in utero exposure to pes-
ticide chemicals; and
(III) available information concerning the cu-
mulative effects on infants and children of such
residues and other substances that have a com-
mon mechanism of toxicity; and
(ii) shall—
(I) ensure that there is a reasonable certainty
that no harm will result to infants and children
from aggregate exposure to the pesticide chemical
residue; and
(II) publish a specific determination regarding
the safety of the pesticide chemical residue for in-
fants and children.
The Secretary of Health and Human Services and the Sec-
retary of Agriculture, in consultation with the Adminis-
trator, shall conduct surveys to document dietary exposure
to pesticides among infants and children. In the case of
threshold effects, for purposes of clause (ii)(I) an additional
-------
Sec. 408 FEDERAL FOOD, DRU6, AND COSMETIC ACT 158
tenfold margin of safety for the pesticide chemical residue
and other sources of exposure shall be applied for infants
and children to take into account potential pre- and post-
natal toxicity and completeness of the data with respect to
exposure and toxicity to infants and children. Notwith-
standing such requirement for an additional margin of
safety, the Administrator may use a different margin of
safety for the pesticide chemical residue only if, on the
basis of reliable data, such margin will be safe for infants
and children.
(D) FACTORS.—In establishing, modifying, leaving in
effect, or revoking a tolerance or exemption for a pesticide
chemical residue, the Administrator shall consider, among
other relevant factors—
(i) the validity, completeness, and reliability of the
available data from studies of the pesticide chemical
and pesticide chemical residue;
(ii) the nature of any toxic effect shown to be
caused by the pesticide chemical or pesticide chemical
residue in such studies;
(iii) available information concerning the relation-
ship of the results of such studies to human risk;
(iv) available information concerning the dietary
consumption patterns of consumers (and major identi-
fiable subgroups of consumers);
(v) available information concerning the cumu-
lative effects of such residues and other substances
that have a common mechanism of toxicity;
(vi) available information concerning the aggre-
gate exposure levels of consumers (and major identifi-
able subgroups of consumers) to the pesticide chemical
residue and to other related substances, including die-
tary exposure under the tolerance and all other toler-
ances in effect for the pesticide chemical residue, and
exposure from other non-occupational sources;
(vii) available information concerning the varia-
bility of the sensitivities of major identifiable sub-
groups of consumers;
(viii) such information as the Administrator may
require on whether the pesticide chemical may have
an effect in humans that is similar to an effect pro-
duced by a naturally occurring estrogen or other endo-
crine effects; and
(ix) safety factors which in the opinion of experts
qualified by scientific training and experience to evalu-
ate the safety of food additives are generally recog-
nized as appropriate for the use of animal experimen-
tation data.
(E) DATA AND INFORMATION REGARDING ANTICIPATED
AND ACTUAL RESIDUE LEVELS.—
(i) AUTHORITY.—In establishing, modifying, leav-
ing in effect, or revoking a tolerance for a pesticide
chemical residue, the Administrator may consider
available data and information on the anticipated resi-
-------
159 FEDERAL FOOD, DRUG, AND COSMETIC ACT Sec. 408
due levels of the pesticide chemical in or on food and
the actual residue levels of the pesticide chemical that
have been measured in food, including residue data
collected by the Food and Drug Administration.
(ii) REQUIREMENT.—If the Administrator relies on
anticipated or actual residue levels in establishing,
modifying, or leaving in effect a tolerance, the Admin-
istrator shall pursuant to subsection (f)(l) require that
data be provided five years after the date on which the
tolerance is established, modified, or left in effect, and
thereafter as the Administrator deems appropriate,
demonstrating that such residue levels are not above
the levels so relied on. If such data are not so pro-
vided, or if the data do not demonstrate that the resi-
due levels are not above the levels so relied on, the
Administrator shall, not later than 180 days after the
date on which the data were required to be provided,
issue a regulation under subsection (e)(l), or an order
under subsection (f)(2), as appropriate, to modify or re-
voke the tolerance.
(F) PERCENT OF FOOD ACTUALLY TREATED.—In estab-
lishing, modifying, leaving in effect, or revoking a toler-
ance for a pesticide chemical residue, the Administrator
may, when assessing chronic dietary risk, consider avail-
able data and information on the percent of food actually
treated with the pesticide chemical (including aggregate
pesticide use data collected by the Department of Agri-
culture) only if the Administrator—
(i) finds that the data are reliable and provide a
valid basis to show what percentage of the food de-
rived from such crop is likely to contain such pesticide
chemical residue;
(ii) finds that the exposure estimate does not un-
derstate exposure for any significant subpopulation
group;
(iii) finds that, if data are available on pesticide
use and consumption of food in a particular area, the
population in such area is not dietarily exposed to res-
idues above those estimated by the Administrator; and
(iv) provides for the periodic reevaluation of the
estimate of anticipated dietary exposure.
(3) DETECTION METHODS.—
(A) GENERAL RULE.—A tolerance for a pesticide chemi-
cal residue in or on a food shall not be established or modi-
fied by the Administrator unless the Administrator deter-
mines, after consultation with the Secretary, that there is
a practical method for detecting and measuring the levels
of the pesticide chemical residue in or on the food
(B) DETECTION LIMIT.—A tolerance for a pesticide
chemical residue in or on a food shall not be established
at or modified to a level lower than the limit of detection
of the method for detecting and measuring the pesticide
chemical residue specified by the Administrator under sub-
paragraph (A).
-------
Sec. 408 FEDERAL FOOD, DRUB, AND COSMETIC ACT 160
(4) INTERNATIONAL STANDARDS.—In establishing a toler-
ance for a pesticide chemical residue in or on a food, the Ad-
ministrator shall determine whether a maximum residue level
for the pesticide chemical has been established by the Codex
Alimentarius Commission. If a Codex maximum residue level
has been established for the pesticide chemical and the Admin-
istrator does not propose to adopt the Codex level, the Admin-
istrator shall publish for public comment a notice explaining
the reasons for departing from the Codex level.
(c) AUTHORITY AND STANDARD FOR EXEMPTIONS.—
(1) AUTHORITY.—The Administrator may issue a regulation
establishing, modifying, or revoking an exemption from the re-
quirement for a tolerance for a pesticide chemical residue in or
on food—
(A) in response to a petition filed under subsection (d);
or
(B) on the Administrator's initiative under subsection
(e).
(2) STANDARD.—
(A) GENERAL RULE.—
(i) STANDARD.—The Administrator may establish
or leave in effect an exemption from the requirement
for a tolerance for a pesticide chemical residue in or on
food only if the Administrator determines that the ex-
emption is safe. The Administrator shall modify or re-
voke an exemption if the Administrator determines it
is not safe.
(ii) DETERMINATION OF SAFETY.—The term "safe",
with respect to an exemption for a pesticide chemical
residue, means that the Administrator has determined
that there is a reasonable certainty that no harm will
result from aggregate exposure to the pesticide chemi-
cal residue, including all anticipated dietary exposures
and all other exposures for which there is reliable in-
formation.
(B) FACTORS.—In making a determination under this
paragraph, the Administrator shall take into account,
among other relevant considerations, the considerations
set forth in subparagraphs (C) and (D) of subsection (b)(2).
(3) LIMITATION.—An exemption from the requirement for a
tolerance for a pesticide chemical residue in or on food shall
not be established or modified by the Administrator unless the
Administrator determines, after consultation with the Sec-
retary—
(A) that there is a practical method for detecting and
measuring the levels of such pesticide chemical residue in
or on food; or
(B) that there is no need for such a method, and states
the reasons for such determination in issuing the regula-
tion establishing or modifying the exemption.
(d) PETITION FOR TOLERANCE OR EXEMPTION.—
(1) PETITIONS AND PETITIONERS.—Any person may file with
the Administrator a petition proposing the issuance of a regu-
lation—
-------
161 _ FEDERAL FOOD, DRUG, AND COSMETIC ACT _ Sec. 408
(A) establishing, modifying, or revoking a tolerance for
a pesticide chemical residue in or on a food; or
(B) establishing, modifying, or revoking an exemption
from the requirement of a tolerance for such a residue.
(2) PETITION CONTENTS. —
(A) ESTABLISHMENT. — A petition under paragraph (1)
to establish a tolerance or exemption for a pesticide chemi-
cal residue shall be supported by such data and informa-
tion as are specified in regulations issued by the Adminis-
trator, including —
(i)(I) an informative summary of the petition and
of the data, information, and arguments submitted or
cited in support of the petition; and
(II) a statement that the petitioner agrees that
such summary or any information it contains may be
published as a part of the notice of filing of the peti-
tion to be published under this subsection and as part
of a proposed or final regulation issued under this sec-
tion;
(ii) the name, chemical identity, and composition
of the pesticide chemical residue and of the pesticide
chemical that produces the residue;
(iii) data showing the recommended amount, fre-
quency, method, and time of application of that pes-
ticide chemical;
(iv) full reports of tests and investigations made
with respect to the safety of the pesticide chemical, in-
cluding full information as to the methods and con-
trols used in conducting those tests and investigations;
(v) full reports of tests and investigations made
with respect to the nature and amount of the pesticide
chemical residue that is likely to remain in or on the
food, including a description of the analytical methods
used;
(vi) a practical method for detecting and measur-
ing the levels of the pesticide chemical residue in or on
the food, or for exemptions, a statement why such a
method is not needed;
(vii) a proposed tolerance for the pesticide chemi-
cal residue, if a tolerance is proposed;
(viii) if the petition relates to a tolerance for a
processed food, reports of investigations conducted
using the processing method(s) used to produce that
food;
(ix) such information as the Administrator may
require to make the determination under subsection
(x) such information as the Administrator may re-
quire on whether the pesticide chemical may have an
effect in humans that is similar to an effect produced
by a naturally occurring estrogen or other endocrine
effects;
-------
Sec. 408 FEDERAL FOOD, DRUG, AND COSMETIC ACT 162
(xi) information regarding exposure to the pes-
ticide chemical residue due to any tolerance or exemp-
tion already granted for such residue;
(xii) practical methods for removing any amount
of the residue that would exceed any proposed toler-
ance; and
(xiii) such other data and information as the Ad-
ministrator requires by regulation to support the peti-
tion.
If information or data required by this subparagraph is
available to the Administrator, the person submitting the
petition may cite the availability of the information or data
in lieu of submitting it. The Administrator may require a
petition to be accompanied by samples of the pesticide
chemical with respect to which the petition is filed.
(B) MODIFICATION OR REVOCATION.—The Adminis-
trator may by regulation establish the requirements for in-
formation and data to support a petition to modify or re-
voke a tolerance or to modify or revoke an exemption from
the requirement for a tolerance.
(3) NOTICE.—A notice of the filing of a petition that the
Administrator determines has met the requirements of para-
graph (2) shall be published by the Administrator within 30
days after such determination. The notice shall announce the
availability of a description of the analytical methods available
to the Administrator for the detection and measurement of the
pesticide chemical residue with respect to which the petition is
filed or shall set forth the petitioner's statement of why such
a method is not needed. The notice shall include the summary
required by paragraph (2)(A)(i)(I).
(4) ACTIONS BY THE ADMINISTRATOR.—
(A) IN GENERAL.—The Administrator shall, after giv-
ing due consideration to a petition filed under paragraph
(1) and any other information available to the Adminis-
trator—
(i) issue a final regulation (which may vary from
that sought by the petition) establishing, modifying, or
revoking a tolerance for the pesticide chemical residue
or an exemption of the pesticide chemical residue from
the requirement of a tolerance (which final regulation
shall be issued without further notice and without fur-
ther period for public comment);
(ii) issue a proposed regulation under subsection
(e), and thereafter issue a final regulation under such
subsection; or
(iii) issue an order denying the petition.
(B) PRIORITIES.—The Administrator shall give priority
to petitions for the establishment or modification of a toler-
ance or exemption for a pesticide chemical residue that ap-
pears to pose a significantly lower risk to human health
from dietary exposure than pesticide chemical residues
that have tolerances in effect for the same or similar uses.
(C) EXPEDITED REVIEW OF CERTAIN PETITIONS.—
-------
163 FEDERAL FOOD, DRUG. AND COSMETIC ACT Sec. 408
(i) DATE CERTAIN FOR REVIEW.—If a person files a
complete petition with the Administrator proposing
the issuance of a regulation establishing a tolerance or
exemption for a pesticide chemical residue that pre-
sents a lower risk to human health than a pesticide
chemical residue for which a tolerance has been left in
effect or modified under subsection (b)(2)(B), the Ad-
ministrator shall complete action on such petition
under this paragraph within 1 year.
(ii) REQUIRED DETERMINATIONS.—If the Adminis-
trator issues a final regulation establishing a tolerance
or exemption for a safer pesticide chemical residue
under clause (i), the Administrator shall, not later
than 180 days after the date on which the regulation
is issued, determine whether a condition described in
subclause (I) or (II) of subsection (b)(2)(B)(iii) contin-
ues to exist with respect to a tolerance that has been
left in effect or modified under subsection (b)(2)(B). If
such condition does not continue to exist, the Adminis-
trator shall, not later than 180 days after the date on
which the determination under the preceding sentence
is made, issue a regulation under subsection (e)(l) to
modify or revoke the tolerance.
(e) ACTION ON ADMINISTRATOR'S OWN INITIATIVE.—
(1) GENERAL RULE.—The Administrator may issue a regu-
lation—
(A) establishing, modifying, suspending under sub-
section (1X3), or revoking a tolerance for a pesticide chemi-
cal or a pesticide chemical residue;
(B) establishing, modifying, suspending under sub-
section (1)(3), or revoking an exemption of a pesticide
chemical residue from the requirement of a tolerance; or
(C) establishing general procedures and requirements
to implement this section.
(2) NOTICE.—Before issuing a final regulation under para-
graph (1), the Administrator shall issue a notice of proposed
rulemaking and provide a period of not less than 60 days for
public comment on the proposed regulation, except that a
shorter period for comment may be provided if the Adminis-
trator for good cause finds that it would be in the public inter-
est to do so and states the reasons for the finding in the notice
of proposed rulemaking.
(f) SPECIAL DATA REQUIREMENTS.—
(1) REQUIRING SUBMISSION OF ADDITIONAL DATA.—If the
Administrator determines that additional data or information
are reasonably required to support the continuation of a toler-
ance or exemption that is in effect under this section for a pes-
ticide chemical residue on a food, the Administrator shall—
(A) issue a notice requiring the person holding the pes-
ticide registrations associated with such tolerance or ex-
emption to submit the data or information under section
3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act;
-------
Sec. 408 FEDERAL FOOD, DRUB. AND COSMETIC ACT 164
(B) issue a rule requiring that testing be conducted on
a substance or mixture under section 4 of the Toxic Sub-
stances Control Act; or
(C) publish in the Federal Register, after first provid-
ing notice and an opportunity for comment of not less than
60 days' duration, an order—
(i) requiring the submission to the Administrator
by one or more interested persons of a notice identify-
ing the person or persons who will submit the required
data and information;
(ii) describing the type of data and information re-
quired to be submitted to the Administrator and stat-
ing why the data and information could not be ob-
tained under the authority of section 3(c)(2)(B) of the
Federal Insecticide, Fungicide, and Rodenticide Act or
section 4 of the Toxic Substances Control Act;
(iii) describing the reports of the Administrator re-
quired to be prepared during and after the collection
of the data and information;
(iv) requiring the submission to the Administrator
of the data, information, and reports referred to in
clauses (ii) and (iii); and
(v) establishing dates by which the submissions
described in clauses (i) and (iv) must be made.
The Administrator may under subparagraph (C) revise any
such order to correct an error. The Administrator may
under this paragraph require data or information pertain-
ing to whether the pesticide chemical may have an effect
in humans that is similar to an effect produced by a natu-
rally occurring estrogen or other endocrine effects.
(2) NONCOMPLIANCE.—If a submission required by a notice
issued in accordance with paragraph (1)(A), a rule issued
under paragraph (1)(B), or an order issued under paragraph
(1)(C) is not made by the time specified in such notice, rule, or
order, the Administrator may by order published in the Fed-
eral Register modify or revoke the tolerance or exemption in
question. In any review of such an order under subsection
(g)(2), the only material issue shall be whether a submission
required under paragraph (1) was not made by the time speci-
fied.
(g) EFFECTIVE DATE, OBJECTIONS, HEARINGS, AND ADMINISTRA-
TIVE REVIEW.—
(1) EFFECTIVE DATE.—A regulation or order issued under
subsection (d)(4), (e)(l), or (f)(2) shall take effect upon publica-
tion unless the regulation or order specifies otherwise. The Ad-
ministrator may stay the effectiveness of the regulation or
order if, after issuance of such regulation or order, objections
are filed with respect to such regulation or order pursuant to
paragraph (2).
(2) FURTHER PROCEEDINGS.—
(A) OBJECTIONS.—Within 60 days after a regulation or
order is issued under subsection (d)(4), (e)(l)(A), (e)(l)(B),
(f)(2), (n)(3), or (n)(5)(C), any person may file objections
thereto with the Administrator, specifying with particular-
-------
165 FEDERAL FOOD, DRU6, AND COSMETIC ACT Sec. 408
ity the provisions of the regulation or order deemed objec-
tionable and stating reasonable grounds therefor. If the
regulation or order was issued in response to a petition
under subsection (d)(l), a copy of each objection filed by a
person other than the petitioner shall be served by the Ad-
ministrator on the petitioner.
(B) HEARING.—An objection may include a request for
a public evidentiary hearing upon the objection. The Ad-
ministrator shall, upon the initiative of the Administrator
or upon the request of an interested person and after due
notice, hold a public evidentiary hearing if and to the ex-
tent the Administrator determines that such a public hear-
ing is necessary to receive factual evidence relevant to ma-
terial issues of fact raised by the objections. The presiding
officer in such a hearing may authorize a party to obtain
discovery from other persons and may upon a showing of
good cause made by a party issue a subpoena to compel
testimony or production of documents from any person.
The presiding officer shall be governed by the Federal
Rules of Civil Procedure in making any order for the pro-
tection of the witness or the content of documents pro-
duced and shall order the payment of reasonable fees and
expenses as a condition to requiring testimony of the wit-
ness. On contest, such a subpoena may be enforced by a
Federal district court.
(C) FINAL DECISION.—As soon as practicable after re-
ceiving the arguments of the parties, the Administrator
shall issue an order stating the action taken upon each
such objection and setting forth any revision to the regula-
tion or prior order that the Administrator has found to be
warranted. If a hearing was held under subparagraph (B),
such order and any revision to the regulation or prior
order shall, with respect to questions of fact at issue in the
hearing, be based only on substantial evidence of record at
such hearing, and shall set forth in detail the findings of
facts and the conclusions of law or policy upon which the
order or regulation is based.
(h) JUDICIAL REVIEW.—
(1) PETITION.—In a case of actual controversy as to the va-
lidity of any regulation issued under subsection (e)(l)(C), or
any order issued under subsection (f)(l)(C) or (g)(2)(C), or any
regulation that is the subject of such an order, any person who
will be adversely affected by such order or regulation may ob-
tain judicial review by filing in the United States Court of Ap-
peals for the circuit wherein that person resides or has its
principal place of business, or in the United States Court of
Appeals for the District of Columbia Circuit, within 60 days
after publication of such order or regulation, a petition praying
that the order or regulation be set aside in whole or in part.
(2) RECORD AND JURISDICTION.—A copy of the petition
under paragraph (1) shall be forthwith transmitted by the
clerk of the court to the Administrator, or any officer des-
ignated by the Administrator for that purpose, and thereupon
the Administrator shall file in the court the record of the pro-
-------
Sec. 408 FEDERAL FOOD, DRUB, AND COSMETIC ACT 166
ceedings on which the Administrator based the order or regula-
tion, as provided in section 2112 of title 28, United States
Code. Upon the filing of such a petition, the court shall have
exclusive jurisdiction to affirm or set aside the order or regula-
tion complained of in whole or in part. As to orders issued fol-
lowing a public evidentiary hearing, the findings of the Admin-
istrator with respect to questions of fact shall be sustained
only if supported by substantial evidence when considered on
the record as a whole.
(3) ADDITIONAL EVIDENCE.—If a party applies to the court
for leave to adduce additional evidence and shows to the satis-
faction of the court that the additional evidence is material and
that there were reasonable grounds for the failure to adduce
the evidence in the proceeding before the Administrator, the
court may order that the additional evidence (and evidence in
rebuttal thereof) shall be taken before the Administrator in the
manner and upon the terms and conditions the court deems
proper. The Administrator may modify prior findings as to the
facts by reason of the additional evidence so taken and may
modify the order or regulation accordingly. The Administrator
shall file with the court any such modified finding, order, or
regulation.
(4) FINAL JUDGMENT; SUPREME COURT REVIEW.—The judg-
ment of the court affirming or setting aside, in whole or in
part, any regulation or any order and any regulation which is
the subject of such an order shall be final, subject to review by
the Supreme Court of the United States as provided in section
1254 of title 28 of the United States Code. The commencement
of proceedings under this subsection shall not, unless specifi-
cally ordered by the court to the contrary, operate as a stay of
a regulation or order.
(5) APPLICATION.—Any issue as to which review is or was
obtainable under this subsection shall not be the subject of ju-
dicial review under any other provision of law.
(i) CONFIDENTIALITY AND USE OF DATA.—
(1) GENERAL RULE.—Data and information that are or
have been submitted to the Administrator under this section or
section 409 in support of a tolerance or an exemption from a
tolerance shall be entitled to confidential treatment for reasons
of business confidentiality and to exclusive use and data com-
pensation to the same extent provided by sections 3 and 10 of
the Federal Insecticide, Fungicide, and Rodenticide Act.
(2) EXCEPTIONS.—
(A) IN GENERAL.—Data and information that are enti-
tled to confidential treatment under paragraph (1) may be
disclosed, under such security requirements as the Admin-
istrator may provide by regulation, to—
(i) employees of the United States authorized by
the Administrator to examine such data and informa-
tion in the carrying out of their official duties under
this Act or other Federal statutes intended to protect
the public health; or
(ii) contractors with the United States authorized
by the Administrator to examine such data and infor-
-------
167 FEDERAL FOOD. DRUE. AND COSMETIC ACT Sec. 408
mation in the carrying out of contracts under this Act
or such statutes.
(B) CONGRESS.—This subsection does not authorize the
withholding of data or information from either House of
Congress or from, to the extent of matter within its juris-
diction, any committee or subcommittee of such committee
or any joint committee of Congress or any subcommittee of
such joint committee.
(3) SUMMARIES.—Notwithstanding any provision of this
subsection or other law, the Administrator may publish the in-
formative summary required by subsection (d)(2)(A)(i) and
may, in issuing a proposed or final regulation or order under
this section, publish an informative summary of the data relat-
ing to the regulation or order.
(j) STATUS OF PREVIOUSLY ISSUED REGULATIONS.—
(1) REGULATIONS UNDER SECTION 406.—Regulations affect-
ing pesticide chemical residues in or on raw agricultural com-
modities promulgated, in accordance with section 701(e), under
the authority of section 406(a) upon the basis of public hear-
ings instituted before January 1, 1953, shall be deemed to be
regulations issued under this section and shall be subject to
modification or revocation under subsections (d) and (e), and
shall be subject to review under subsection (q).
(2) REGULATIONS UNDER SECTION 409.—Regulations that es-
tablished tolerances for substances that are pesticide chemical
residues in or on processed food, or that otherwise stated the
conditions under which such pesticide chemicals could be safe-
ly used, and that were issued under section 409 on or before
the date of the enactment of this paragraph, shall be deemed
to be regulations issued under this section and shall be subject
to modification or revocation under subsection (d) or (e), and
shall be subject to review under subsection (q).
(3) REGULATIONS UNDER SECTION 408.—Regulations that es-
tablished tolerances or exemptions under this section that were
issued on or before the date of the enactment of this paragraph
shall remain in effect unless modified or revoked under sub-
section (d) or (e), and shall be subject to review under sub-
section (q).
(k) TRANSITIONAL PROVISION.—If, on the day before the date of
the enactment of this subsection, a substance that is a pesticide
chemical was, with respect to a particular pesticidal use of the sub-
stance and any resulting pesticide chemical residue in or on a par-
ticular food—
(1) regarded by the Administrator or the Secretary as gen-
erally recognized as safe for use within the meaning of the pro-
visions of subsection (a) or section 201(s) as then in effect; or
(2) regarded by the Secretary as a substance described by
section 201(s)(4);
such a pesticide chemical residue shall be regarded as exempt from
the requirement for a tolerance, as of the date of enactment of this
subsection. The Administrator shall by regulation indicate which
substances are described by this subsection. Any exemption under
this subsection may be modified or revoked as if it had been issued
under subsection (c).
-------
Sec. 408 FEDERAL FOOD, DRUE, AND COSMETIC ACT 168
(1) HARMONIZATION WITH ACTION UNDER OTHER LAWS.—
(1) COORDINATION WITH PIFRA.—To the extent practicable
and consistent with the review deadlines in subsection (q), in
issuing a final rule under this subsection that suspends or re-
vokes a tolerance or exemption for a pesticide chemical residue
in or on food, the Administrator shall coordinate such action
with any related necessary action under the Federal Insecti-
cide, Fungicide, and Rodenticide Act.
(2) REVOCATION OF TOLERANCE OR EXEMPTION FOLLOWING
CANCELLATION OF ASSOCIATED REGISTRATIONS.—If the Adminis-
trator, acting under the Federal Insecticide, Fungicide, and
Rodenticide Act, cancels the registration of each pesticide that
contains a particular pesticide chemical and that is labeled for
use on a particular food, or requires that the registration of
each such pesticide be modified to prohibit its use in connec-
tion with the production, storage, or transportation of such
food, due in whole or in part to dietary risks to humans posed
by residues of that pesticide chemical on that food, the Admin-
istrator shall revoke any tolerance or exemption that allows
the presence of the pesticide chemical, or any pesticide chemi-
cal residue that results from its use, in or on that food. Sub-
section (e) shall apply to actions taken under this paragraph.
A revocation under this paragraph shall become effective not
later than 180 days after—
(A) the date by which each such cancellation of a reg-
istration has become effective; or
(B) the date on which the use of the canceled pesticide
becomes unlawful under the terms of the cancellation,
whichever is later.
(3) SUSPENSION OF TOLERANCE OR EXEMPTION FOLLOWING
SUSPENSION OF ASSOCIATED REGISTRATIONS.—
(A) SUSPENSION.—If the Administrator, acting under
the Federal Insecticide, Fungicide, and Rodenticide Act,
suspends the use of each registered pesticide that contains
a particular pesticide chemical and that is labeled for use
on a particular food, due in whole or in part to dietary
risks to humans posed by residues of that pesticide chemi-
cal on that food, the Administrator shall suspend any tol-
erance or exemption that allows the presence of the pes-
ticide chemical, or any pesticide chemical residue that re-
sults from its use, in or on that food. Subsection (e) shall
apply to actions taken under this paragraph. A suspension
under this paragraph shall become effective not later than
60 days after the date by which each such suspension of
use has become effective.
(B) EFFECT OF SUSPENSION.—The suspension of a tol-
erance or exemption under subparagraph (A) shall be ef-
fective as long as the use of each associated registration of
a pesticide is suspended under the Federal Insecticide,
Fungicide, and Rodenticide Act. While a suspension of a
tolerance or exemption is effective the tolerance or exemp-
tion shall not be considered to be in effect. If the suspen-
sion of use of the pesticide under that Act is terminated,
leaving the registration of the pesticide for such use in ef-
-------
169 FEDERAL FOOD. DRUG, AND COSMETIC ACT Sec. 408
feet under that Act, the Administrator shall rescind any
associated suspension of tolerance or exemption.
(4) TOLERANCES FOR UNAVOIDABLE RESIDUES.—In connec-
tion with action taken under paragraph (2) or (3), or with re-
spect to pesticides whose registrations were suspended or can-
celed prior to the date of the enactment of this paragraph
under the Federal Insecticide, Fungicide, and Rodenticide Act,
if the Administrator determines that a residue of the canceled
or suspended pesticide chemical will unavoidably persist in the
environment and thereby be present in or on a food, the Ad-
ministrator may establish a tolerance for the pesticide chemi-
cal residue. In establishing such a tolerance, the Administrator
shall take into account both the factors set forth in subsection
(b)(2) and the unavoidability of the residue. Subsection (e) shall
apply to the establishment of such tolerance. The Adminis-
trator shall review any such tolerance periodically and modify
it as necessary so that it allows no greater level of the pesticide
chemical residue than is unavoidable.
(5) PESTICIDE RESIDUES RESULTING PROM LAWFUL APPLICA-
TION OF PESTICIDE.—Notwithstanding any other provision of
this Act, if a tolerance or exemption for a pesticide chemical
residue in or on a food has been revoked, suspended, or modi-
fied under this section, an article of that food shall not be
deemed unsafe solely because of the presence of such pesticide
chemical residue in or on such food if it is shown to the satis-
faction of the Secretary that—
(A) the residue is present as the result of an applica-
tion or use of a pesticide at a time and in a manner that
was lawful under the Federal Insecticide, Fungicide, and
Rodenticide Act; and
(B) the residue does not exceed a level that was au-
thorized at the time of that application or use to be
present on the food under a tolerance, exemption, food ad-
ditive regulation, or other sanction then in effect under
this Act;
unless, in the case of any tolerance or exemption revoked, sus-
pended, or modified under this subsection or subsection (d) or
(e), the Administrator has issued a determination that con-
sumption of the legally treated food during the period of its
likely availability in commerce will pose an unreasonable die-
tary risk.
(6) TOLERANCE FOR USE OF PESTICIDES UNDER AN EMER-
GENCY EXEMPTION.—If the Administrator grants an exemption
under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the
Administrator shall establish a tolerance or exemption from
the requirement for a tolerance for the pesticide chemical resi-
due. Such a tolerance or exemption from a tolerance shall have
an expiration date. The Administrator may establish such a
tolerance or exemption without providing notice or a period for
comment on the tolerance or exemption. The Administrator
shall promulgate regulations within 365 days after the date of
the enactment of this paragraph governing the establishment
of tolerances and exemptions under this paragraph. Such regu-
-------
Sec. 408 FEDERAL FOOD, DRUB, AND COSMETIC ACT 170
lations shall be consistent with the safety standard under sub-
sections (b)(2) and (c)(2) and with section 18 of the Federal In-
secticide, Fungicide, and Rodenticide Act.
(m) FEES.—
(1) AMOUNT.—The Administrator shall by regulation re-
quire the payment of such fees as will in the aggregate, in the
judgment of the Administrator, be sufficient over a reasonable
term to provide, equip, and maintain an adequate service for
the performance of the Administrator's functions under this
section. Under the regulations, the performance of the Admin-
istrator's services or other functions under this section, includ-
ing—
(A) the acceptance for filing of a petition submitted
under subsection (d);
(B) establishing, modifying, leaving in effect, or revok-
ing a tolerance or establishing, modifying, leaving in effect,
or revoking an exemption from the requirement for a toler-
ance under this section;
(C) the acceptance for filing of objections under sub-
section (g); or
(D) the certification and filing in court of a transcript
of the proceedings and the record under subsection (h);
may be conditioned upon the payment of such fees. The regula-
tions may further provide for waiver or refund of fees in whole
or in part when in the judgment of the Administrator such a
waiver or refund is equitable and not contrary to the purposes
of this subsection.
(2) DEPOSIT.—All fees collected under paragraph (1) shall
be deposited in the Reregistration and Expedited Processing
Fund created by section 4(k) of the Federal Insecticide, Fun-
gicide, and Rodenticide Act. Such fees shall be available to the
Administrator, without fiscal year limitation, for the perform-
ance of the Administrator's services or functions as specified in
paragraph (1).
(n) NATIONAL UNIFORMITY OF TOLERANCES.—
(1) QUALIFYING PESTICIDE CHEMICA^ RESIDUE.—For pur-
poses of this subsection, the term "qualifying pesticide chemi-
cal residue" means a pesticide chemical residue resulting from
the use, in production, processing, or storage of a food, of a pes-
ticide chemical that is an active ingredient and that-y-
(A) was first approved for such use in a registration of
a pesticide issued under section 3(c)(5) of the Federal In-
secticide, Fungicide, and Rodenticide Act on or after April
25, 1985, on the basis of data determined by the Adminis-
trator to meet all applicable requirements for data pre-
scribed by regulations in effect under that Act on April 25,
1985; or
(B) was approved for such use in a reregistration eligi-
bility determination issued under section 4(g) of that Act
on or after the date of enactment of this subsection.
(2) QUALIFYING FEDERAL DETERMINATION.—For purposes of
this subsection, the term "qualifying Federal determination"
means a tolerance or exemption from the requirement for a tol-
erance for a qualifying pesticide chemical residue that—
-------
171 FEDERAL FOOD, DRUS, AND COSMETIC ACT Sec. 408
(A) is issued under this section after the date of the
enactment of this subsection and determined by the Ad-
ministrator to meet the standard under subsection
(b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case
of an exemption); or
(B)(i) pursuant to subsection (j) is remaining in effect
or is deemed to have been issued under this section, or is
regarded under subsection (k) as exempt from the require-
ment for a tolerance; and
(ii) is determined by the Administrator to meet the
standard under subsection (b)(2)(A) (in the case of a toler-
ance) or (c)(2) (in the case of an exemption).
(3) LIMITATION.—The Administrator may make the deter-
mination described in paragraph (2)(B)(ii) only by issuing a
rule in accordance with the procedure set forth in subsection
(d) or (e) and only if the Administrator issues a proposed rule
and allows a period of not less than 30 days for comment on
the proposed rule. Any such rule shall be reviewable in accord-
ance with subsections (g) and (h).
(4) STATE AUTHORITY.—Except as provided in paragraphs
(5), (6), and (8) no State or political subdivision may establish
or enforce any regulatory limit on a qualifying pesticide chemi-
cal residue in or on any food if a qualifying Federal determina-
tion applies to the presence of such pesticide chemical residue
in or on such food, unless such State regulatory limit is iden-
tical to such qualifying Federal determination. A State or polit-
ical subdivision shall be deemed to establish or enforce a regu-
latory limit on a pesticide chemical residue in or on a food if
it purports to prohibit or penalize the production, processing,
shipping, or other handling of a food because it contains a pes-
ticide residue (in excess of a prescribed limit).
(5) PETITION PROCEDURE.—
(A) IN GENERAL.—Any State may petition the Adminis-
trator for authorization to establish in such State a regu-
latory limit on a qualifying pesticide chemical residue in or
on any food that is not identical to the qualifying Federal
determination applicable to such qualifying pesticide
chemical residue.
(B) PETITION REQUIREMENTS.—Any petition under sub-
paragraph (A) shall—
(i) satisfy any requirements prescribed, by rule, by
the Administrator; and
(ii) be supported by scientific data about the pes-
ticide chemical residue that is the subject of the peti-
tion or about chemically related pesticide chemical res-
idues, data on the consumption within such State of
food bearing the pesticide chemical residue, and data
on exposure of humans within such State to the pes-
ticide chemical residue.
(C) AUTHORIZATION.—The Administrator may, by
order, grant the authorization described in subparagraph
(A) if the Administrator determines that the proposed
State regulatory limit—
(i) is justified by compelling local conditions; and
-------
Sec. 408 FEDERAL FOOD, DRUG. AND COSMETIC ACT 172
(ii) would not cause any food to be a violation of
Federal law.
(D) TREATMENT.—In lieu of any action authorized
under subparagraph (C), the Administrator may treat a
petition under this paragraph as a petition under sub-
section (d) to modify or revoke a tolerance or an exemp-
tion. If the Administrator determines to treat a petition
under this paragraph as a petition under subsection (d),
the Administrator shall thereafter act on the petition pur-
suant to subsection (d).
(E) REVIEW.—Any order of the Administrator granting
or denying the authorization described in subparagraph
(A) shall be subject to review in the manner described in
subsections (g) and (h).
(6) URGENT PETITION PROCEDURE.—Any State petition to
the Administrator pursuant to paragraph (5) that dem-
onstrates that consumption of a food containing such pesticide
residue level during the period of the food's likely availability
in the State will pose a significant public health threat from
acute exposure shall be considered an urgent petition. If an
order by the Administrator to grant or deny the requested au-
thorization in an urgent petition is not made within 30 days
of receipt of the petition, the petitioning State may establish
and enforce a temporary regulatory limit on a qualifying pes-
ticide chemical residue in or on the food. The temporary regu-
latory limit shall be validated or terminated by the Adminis-
trator's final order on the petition.
(7) RESIDUES FROM LAWFUL, APPLICATION.—No State or po-
litical subdivision may enforce any regulatory limit on the level
of a pesticide chemical residue that may appear in or on any
food if, at the time of the application of the pesticide that re-
sulted in such residue, the sale of such food with such residue
level was lawful under this section and under the law of such
State, unless the State demonstrates that consumption of the
food containing such pesticide residue level during the period
of the food's likely availability in the State will pose an unrea-
sonable dietary risk to the health of persons within such State.
(8) SAVINGS.—Nothing in this Act preempts the authority
of any State or political subdivision to require that a food con-
taining a pesticide chemical residue bear or be the subject of
a warning or other statement relating to the presence of the
pesticide chemical residue in or on such food.
(o) CONSUMER RIGHT To KNOW.—Not later than 2 years after
the date of the enactment of the Food Quality Protection Act of
1996, and annually thereafter, the Administrator shall, in consulta-
tion with the Secretary of Agriculture and the Secretary of Health
and Human Services, publish in a format understandable to a lay
person, and distribute to large retail grocers for public display (in
a manner determined by the grocer), the following information, at
a minimum:
(1) A discussion of the risks and benefits of pesticide chem-
ical residues in or on food purchased by consumers.
(2) A listing of actions taken under subparagraph (B) of
subsection (b)(2) that may result in pesticide chemical residues
-------
173 FEDERAL FOOD, DRUG, AND COSMETIC ACT Sec. 408
in or on food that present a yearly or lifetime risk above the
risk allowed under subparagraph (A) of such subsection, and
the food on which the pesticide chemicals producing the resi-
dues are used.
(3) Recommendations to consumers for reducing dietary ex-
posure to pesticide chemical residues in a manner consistent
with maintaining a healthy diet, including a list of food that
may reasonably substitute for food listed under paragraph (2).
Nothing in this subsection shall prevent retail grocers from
providing additional information.
(p) ESTROGENIC SUBSTANCES SCREENING PROGRAM.—
(1) DEVELOPMENT.—Not later than 2 years after the date
of enactment of this section, the Administrator shall in con-
sultation with the Secretary of Health and Human Services de-
velop a screening program, using appropriate validated test
systems and other scientifically relevant information, to deter-
mine whether certain substances may have an effect in hu-
mans that is similar to an effect produced by a naturally occur-
ring estrogen, or such other endocrine effect as the Adminis-
trator may designate.
(2) IMPLEMENTATION.—Not later than 3 years after the
date of enactment of this section, after obtaining public com-
ment and review of the screening program described in para-
graph (1) by the scientific advisory panel established under
section 25(d) of the Federal Insecticide, Fungicide, and
Rodenticide Act or the science advisory board established by
section 8 of the Environmental Research, Development, and
Demonstration Act of 1978 (42 U.S.C. 4365), the Administrator
shall implement the program.
(3) SUBSTANCES.—In carrying out the screening program
described in paragraph (1), the Administrator—
(A) shall provide for the testing of all pesticide chemi-
cals; and
(B) may provide for the testing of any other substance
that may have an effect that is cumulative to an effect of
a pesticide chemical if the Administrator determines that
a substantial population may be exposed to such sub-
stance.
(4) EXEMPTION.—Notwithstanding paragraph (3), the Ad-
ministrator may, by order, exempt from the requirements of
this section a biologic substance or other substance if the Ad-
ministrator determines that the substance is anticipated not to
produce any effect in humans similar to an effect produced by
a naturally occurring estrogen.
(5) COLLECTION OF INFORMATION.—
(A) IN GENERAL.—The Administrator shall issue an
order to a registrant of a substance for which testing is re-
quired under this subsection, or to a person who manufac-
tures or imports a substance for which testing is required
under this subsection, to conduct testing in accordance
with the screening program described in paragraph (1),
and submit information obtained from the testing to the
Administrator, within a reasonable time period that the
-------
Sec. 408 FEDERAL FOOD, DRUG, AND COSMETIC ACT 174
Administrator determines is sufficient for the generation of
the information.
(B) PROCEDURES.—To the extent practicable the Ad-
ministrator shall minimize duplicative testing of the same
substance for the same endocrine effect, develop, as appro-
priate, procedures for fair and equitable sharing of test
costs, and develop, as necessary, procedures for handling of
confidential business information.
(C) FAILURE OF REGISTRANTS TO SUBMIT INFORMA-
TION.—
(i) SUSPENSION.—If a registrant of a substance re-
ferred to in paragraph (3)(A) fails to comply with an
order under subparagraph (A) of this paragraph, the
Administrator shall issue a notice of intent to suspend
the sale or distribution of the substance by the reg-
istrant. Any suspension proposed under this para-
graph shall become final at the end of the 30-day pe-
riod beginning on the date that the registrant receives
the notice of intent to suspend, unless during that pe-
riod a person adversely affected by the notice requests
a hearing or the Administrator determines that the
registrant has complied fully with this paragraph.
(ii) HEARING.—If a person requests a hearing
under clause (i), the hearing shall be conducted in ac-
cordance with section 554 of title 5, United States
Code. The only matter for resolution at the hearing
shall be whether the registrant has failed to comply
with an order under subparagraph (A) of this para-
graph. A decision by the Administrator after comple-
tion of a hearing shall be considered to be a final
agency action.
(iii) TERMINATION OF SUSPENSIONS.—The Adminis-
trator shall terminate a suspension under this sub-
paragraph issued with respect to a registrant if the
Administrator determines that the registrant has com-
plied fully with this paragraph.
(D) NONCOMPLIANCE BY OTHER PERSONS.—Any person
(other than a registrant) who fails to comply with an order
under subparagraph (A) shall be liable for the same pen-
alties and sanctions as are provided under section 16 of
the Toxic Substances Control Act (15 U.S.C. 2601 and fol-
lowing) in the case of a violation referred to in that sec-
tion. Such penalties and sanctions shall be assessed and
imposed in the same manner as provided in such section
16.
(6) AGENCY ACTION.—In the case of any substance that is
found, as a result of testing and evaluation under this section,
to have an endocrine effect on humans, the Administrator
shall, as appropriate, take action under such statutory author-
ity as is available to the Administrator, including consideration
under other sections of this Act, as is necessary to ensure the
protection of public health.
-------
175 FEDERAL FOOD. DRU6, AND COSMETIC ACT Sec. 408
(7) REPORT TO CONGRESS.—Not later than 4 years after the
date of enactment of this section, the Administrator shall pre-
pare and submit to Congress a report containing—
(A) the findings of the Administrator resulting from
the screening program described in paragraph (1);
(B) recommendations for further testing needed to
evaluate the impact on human health of the substances
tested under the screening program; and
(C) recommendations for any further actions (includ-
ing any action described in paragraph (6)) that the Admin-
istrator determines are appropriate based on the findings.
(q) SCHEDULE FOR REVIEW.—
(1) IN GENERAL.—The Administrator shall review toler-
ances and exemptions for pesticide chemical residues in effect
on the day before the date of the enactment of the Food Qual-
ity Protection Act of 1996, as expeditiously as practicable, as-
suring that—
(A) 33 percent of such tolerances and exemptions are
reviewed within 3 years of the date of enactment of such
Act;
(B) 66 percent of such tolerances and exemptions are
reviewed within 6 years of the date of enactment of such
Act; and
(C) 100 percent of such tolerances and exemptions are
reviewed within 10 years of the date of enactment of such
Act.
In conducting a review of a tolerance or exemption, the Admin-
istrator shall determine whether the tolerance or exemption
meets the requirements of subsections (b)(2) or (c)(2) and shall,
by the deadline for the review of the tolerance or exemption,
issue a regulation under subsection (d)(4) or (e)(l) to modify or
revoke the tolerance or exemption if the tolerance or exemption
does not meet such requirements.
(2) PRIORITIES.—In determining priorities for reviewing
tolerances and exemptions under paragraph (1), the Adminis-
trator shall give priority to the review of the tolerances or ex-
emptions that appear to pose the greatest risk to public health.
(3) PUBLICATION OF SCHEDULE.—Not later than 12 months
after the date of the enactment of the Food Quality Protection
Act of 1996, the Administrator shall publish a schedule for re-
view of tolerances and exemptions established prior to the date
of the enactment of the Food Quality Protection Act of 1996.
The determination of priorities for the review of tolerances and
exemptions pursuant to this subsection is not a rulemaking
and shall not be subject to judicial review, except that failure
to take final action pursuant to the schedule established by
this paragraph shall be subject to judicial review.
(r) TEMPORARY TOLERANCE OR EXEMPTION.—The Administrator
may, upon the request of any person who has obtained an experi-
mental permit for a pesticide chemical under the Federal Insecti-
cide, Fungicide, and Rodenticide Act or upon the Administrator's
own initiative, establish a temporary tolerance or exemption for the
pesticide chemical residue for the uses covered by the permit. Sub-
-------
Sec. 409 FEDERAL FOOD, DRUG. AND COSMETIC ACT 176
sections (b)(2), (c)(2), (d), and (e) shall apply to actions taken under
this subsection.
(s) SAVINGS CLAUSE.—Nothing in this section shall be con-
strued to amend or modify the provisions of the Toxic Substances
Control Act or the Federal Insecticide, Fungicide, and Rodenticide
Act.
FOOD ADDITIVES
Unsafe Food Additives
SEC. 409. [348] (a) A food additive shall, with respect to any
particular use or intended use of such additives, be deemed to be
unsafe for the purposes of the application of clause (2)(C) of section
402(a), unless—
(1) it and its use or intended use conform to the terms of
an exemption which is in effect pursuant to subsection (i) of
this section; or
(2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section pre-
scribing the conditions under which such additive may be safe-
ly used.
While such a regulation relating to a food additive is in effect, a
food shall not, by reason of bearing or containing such an additive
in accordance with the regulation, be considered adulterated within
the meaning of clause (1) of section 402(a).
Petition To Establish Safety
(b)(l) Any person may, with respect to any intended use of a
food additive, file with the Secretary a petition proposing the issu-
ance of a regulation prescribing the conditions under which such
additive may be safely used.
(2) Such petition shall, in addition to any explanatory or sup-
porting data, contain—
(A) the name and all pertinent information concerning
such food additive, including, where available, its chemical
identity and composition;
(B) a statement of the conditions of the proposed use of
such additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and includ-
ing specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other tech-
nical effect such additive is intended to produce, and the quan-
tity of such additive required to produce such effect;
(D) a description of practicable methods for determining
the quantity of such additive in or on food, and any substance
formed in or on food, because of its use; and
(E) full reports of investigations made with respect to the
safety for use of such additive, including full information as to
the methods and controls used in conducting such investiga-
tions.
(3) Upon request of the Secretary, the petitioner shall furnish
(or, if the petitioner is not the manufacturer of such additive, the
petitioner shall have the manufacturer of such additive furnish,
-------
177 FEDERAL FOOD, DRUG, AND COSMETIC ACT Sec. 409
without disclosure to the petitioner), a full description of the meth-
ods used in, and the facilities and controls used for, the production
of such additive.
(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as compo-
nents thereof, and of the food in or on which the additive is pro-
posed to be used.
(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days
after filing.
Action on the Petition
(c)(l) The Secretary shall—
(A) by order establish a regulation (whether or not in ac-
cord with that proposed by the petitioner) prescribing, with re-
spect to one or more proposed uses of the food additive in-
volved, the conditions under which such additive may be safely
used (including, but not limited to, specifications as to the par-
ticular food or classes of food in or on which such additive may
be used, the maximum quantity which may be used or per-
mitted to remain in or on such food, the manner in which such
additive may be added to or used in or on such food, and any
directions or other labeling or packaging requirements for such
additive deemed necessary by him to assure the safety of such
use), and shall notify the petitioner of such order and the rea-
sons for such action; or
(B) by order deny the petition, and shall notify the peti-
tioner of such order and of the reasons for such action.
(2) The order required by paragraph (1) (A) or (B) of this sub-
section shall be issued within ninety days after the date of filing
of the petition, except that the Secretary may (prior to such nine-
tieth day), by written notice to the petitioner, extend such ninety-
day period to such time (not more than one hundred and eighty
days after the date of filing of the petition) as the Secretary deems
necessary to enable him to study and investigate the petition.
(3) No such regulation shall issue if a fair evaluation of the
data before the Secretary—
(A) fails to establish that the proposed use of the food addi-
tive, under the conditions of use to be specified in the regula-
tion, will be safe: Provided, That no additive shall be deemed
to be safe if it is found to induce cancer when ingested by man
or animal, or if it is found, after tests which are appropriate
for the evaluation of the safety of food additives, to induce can-
cer in man or animal, except that this proviso shall not apply
with respect to the use of a substance as an ingredient of feed
for animals which are raised for food production, if the Sec-
retary finds (i) that, under the conditions of use and feeding
specified in proposed labeling and reasonably certain to be fol-
lowed in practice, such additive will not adversely affect the
animals for which such feed is intended, and (ii) that no resi-
due of the additive will be found (by methods of examination
prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (f) and (g)) in
-------
Sec. 409 FEDERAL FOOD, DRUB, AND COSMETIC ACT 178
any edible portion of such animal after slaughter or in any food
yielded by or derived from the living animal; or
(B) shows that the proposed use of the additive would pro-
mote deception of the consumer in violation of this Act or
would otherwise result in adulteration or in misbranding of
food within the meaning of this Act.
(4) If, in the judgment of the Secretary, based upon a fair eval-
uation of the data before him, a tolerance limitation is required in
order to assure that the proposed use of an additive will be safe,
the Secretary—
(A) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
physical or other technical effect for which such additive is in-
tended; and
(B) shall not establish a regulation for such proposed use
if he finds upon a fair evaluation of the data before him that
such data do not establish that such use would accomplish the
intended physical or other technical effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall consider
among other relevant factors—
(A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the addi-
tive;
(B) the cumulative effect of such additive in the diet of
man or animals, taking into account any chemically or phar-
macologically related substance or substances in such diet; and
(C) safety factors which in the opinion of experts qualified
by scientific training and experience to evaluate the safety of
food additives are generally recognized as appropriate for the
use of animal experimentation data.
Regulation Issued on Secretary's Initiative
(d) The Secretary may at any time, upon his own initiative,
propose the issuance of a regulation prescribing, with respect to
any particular use of a food additive, the conditions under which
such additive may be safely used, and the reasons therefor. After
the thirtieth day following publication of such a proposal, the Sec-
retary may by order establish a regulation based upon the pro-
posal.
Publication and Effective Date of Orders
(e) Any order, including any regulation established by such
order, issued under subsection (c) or (d) of this section, shall be
published and shall be effective upon publication, but the Secretary
may stay such effectiveness if, after issuance of such order, a hear-
ing is sought with respect to such order pursuant to subsection (f).
Objections and Public Hearing
(f)(l) Within thirty days after publication of an order made
pursuant to subsection (c) or (d) of this section, any person ad-
-------
179 FEDERAL FOOD, DRUG, AND COSMETIC ACT Sec. 409
versely affected by such an order may file objections thereto with
the Secretary, specifying with particularity the provisions of the
order deemed objectionable, stating reasonable grounds therefor,
and requesting a public hearing upon such objections. The Sec-
retary shall, after due notice, as promptly as possible hold such
public hearing for the purpose of receiving evidence relevant and
material to the issues raised by such objections. As soon as prac-
ticable after completion of the hearing, the Secretary shall by order
act upon such objections and make such order public.
(2) Such order shall be based upon a fair evaluation of the en-
tire record at such hearing, and shall include a statement setting
forth in detail the findings and conclusions upon which the order
is based.
(3) The Secretary shall specify in the order the date on which
it shall take effect, except that it shall not be made to take effect
prior to the ninetieth day after its publication, unless the Secretary
finds that emergency conditions exist necessitating an earlier effec-
tive date, in which event the Secretary shall specify in the order
his findings as to such conditions.
Judicial Review
(g)(l) In a case of actual controversy as to the validity of any
order issued under subsection (f), including any order thereunder
with respect to amendment or repeal of a regulation issued under
this section, any person who will be adversely affected by such
order may obtain judicial review by filing in the United States
Court of Appeals for the circuit wherein such person resides or has
his principal place of business, or in the United States Court of Ap-
peals for the District of Columbia Circuit, within sixty days after
the entry of such order, a petition praying that the order be set
aside in whole or in part.
(2) A copy of such petition shall be forthwith transmitted by
the clerk of the court to the Secretary, or any officer designated by
him for that purpose, and thereupon the Secretary shall file in the
court the record of the proceedings on which he based his order, as
provided in section 2112 of title 28, United States Code. Upon the
filing of such petition the court shall have jurisdiction, which upon
the filing of the record with it shall be exclusive, to affirm or set
aside the order complained of in whole or in part. Until the filing
of the record the Secretary may modify or set aside his order. The
findings of the Secretary with respect to questions of fact shall be
sustained if based upon a fair evaluation of the entire record at
such hearing.
(3) The court, on such judicial review, shall not sustain the
order of the Secretary if he failed to comply with any requirement
imposed on him by subsection (f)(2) of this section.
(4) If application is made to the court for leave to adduce addi-
tional evidence, the court may order such additional evidence to be
taken before the Secretary and to be adduced upon the hearing in
such manner and upon such terms and conditions as to the court
may seem proper, if such evidence is material and there were rea-
sonable grounds for failure to adduce such evidence in the proceed-
ings below. The Secretary may modify his findings as to the facts
-------
Sec. 410 FEDERAL FOOD. DRUE, AND COSMETIC ACT 180
and order by reason of the additional evidence so taken, and shall
file with the court such modified findings and order.
(5) The judgment of the court affirming or setting aside, in
whole or in part, any order under this section shall be final, subject
to review by the Supreme Court of the United States upon certio-
rari or certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
section shall not, unless specifically ordered by the court to the con-
trary, operate as a stay of an order.
Amendment or Repeal of Regulations
(h) The Secretary shall by regulation prescribe the procedure
by which regulations under the foregoing provisions of this section
may be amended or repealed, and such procedure shall conform to
the procedure provided in this section for the promulgation of such
regulations.
Exemptions for Investigational Use
(i) Without regard to subsections (b) to (h), inclusive, of this
section, the Secretary shall by regulation provide for exempting
from the requirements of this section any food additive, and any
food bearing or containing such additive, intended solely for inves-
tigational use by qualified experts when in his opinion such exemp-
tion is consistent with the public health.
BOTTLED DRINKING WATER STANDARDS
SEC. 410. [349] (a) Except as provided in subsection (b), when-
ever the Administrator of the Environmental Protection Agency
prescribes interim or revised national primary drinking water regu-
lations under section 1412 of the Public Health Service Act, the
Secretary shall consult with the Administrator and within 180 days
after the promulgation of such drinking water regulations either
promulgate amendments to regulations under this chapter applica-
ble to bottled drinking water or publish in the Federal Register his
reasons for not making such amendments.
(b)(l) Not later than 180 days before the effective date of a na-
tional primary drinking water regulation promulgated by the Ad-
ministrator of the Environmental Protection Agency for a contami-
nant under section 1412 of the Safe Drinking Water Act (42 U.S.C.
300g-l), the Secretary shall promulgate a standard of quality regu-
lation under this subsection for that contaminant in bottled water
or make a finding that such a regulation is not necessary to protect
the public health because the contaminant is contained in water in
public water systems (as defined under section 1401(4) of such Act
(42 U.S.C. 300fl;4))) but not in water used for bottled drinking
water. The effective date for any such standard of quality regula-
tion shall be the same as the effective date for such national pri-
mary drinking water regulation, except for any standard of quality
of regulation promulgated by the Secretary before the date of en-
actment of the Safe Drinking Water Act Amendments of 1996 for
which (as of such date of enactment) an effective date had not been
established. In the case of a standard of quality regulation to which
such exception applies, the Secretary shall promulgate monitoring
-------
181 FEDERAL FOOD, DRUG, AND COSMETIC ACT Sec. 411
requirements for the contaminants covered by the regulation not
later than 2 years after such date of enactment.
(2) A regulation issued by the Secretary as provided in this
subsection shall include any monitoring requirements that the Sec-
retary determines appropriate for bottled water.
(3) A regulation issued by the Secretary as provided in this
subsection shall require the following:
(A) In the case of contaminants for which a maximum con-
taminant level is established in a national primary drinking
water regulation under section 1412 of the Safe Drinking
Water Act (42 U.S.C. 300g-l), the regulation under this sub-
section shall establish a maximum contaminant level for the
contaminant in bottled water which is no less stringent than
the maximum contaminant level provided in the national pri-
mary drinking water regulation.
(B) In the case of contaminants for which a treatment
technique is established in a national primary drinking water
regulation under section 1412 of the Safe Drinking Water Act
(42 U.S.C. 300g-l), the regulation under this subsection shall
require that bottled water be subject to requirements no less
protective of the public health than those applicable to water
provided by public water systems using the treatment tech-
nique required by the national primary drinking water regula-
tion.
(4)(A) If the Secretary does not promulgate a regulation under
this subsection within the period described in paragraph (1), the
national primary drinking water regulation referred to in para-
graph (1) shall be considered, as of the date on which the Secretary
is required to establish a regulation under paragraph (1), as the
regulation applicable under this subsection to bottled water.
(B) In the case of a national primary drinking water regulation
that pursuant to subparagraph (A) is considered to be a standard
of quality regulation, the Secretary shall, not later than the appli-
cable date referred to in such subparagraph, publish in the Federal
Register a notice—
(i) specifying the contents of such regulation, including
monitoring requirements; and
(ii) providing that for purposes of this paragraph the effec-
tive date for such regulation is the same as the effective date
for the regulation for purposes of the Safe Drinking Water Act
(or, if the exception under paragraph (1) applies to the regula-
tion, that the effective date for the regulation is not later than
2 years and 180 days after the date of enactment of the Safe
Drinking Water Act Amendments of 1996).
VITAMINS AND MINERALS
SEC. 411. [350] (a)(l) Except as provided in paragraph (2)—
(A) the Secretary may not establish, under section 201(n),
401, or 403, maximum limits on the potency of any synthetic
or natural vitamin or mineral within a food to which this sec-
tion applies;
(B) the Secretary may not classify any natural or synthetic
vitamin or mineral (or combination thereof) as a drug solely
-------
Sec. 411 FEDERAL FOOD, DRUB, AND COSMETIC ACT 182
because it exceeds the level of potency which the Secretary de-
termines is nutritionally rational or useful;
(C) the Secretary may not limit, under section 201(n), 401,
or 403, the combination or number of any synthetic or natu-
ral—
(i) vitamin,
(ii) mineral, or
(iii) other ingredient of food,
within a food to which this section applies.
(2) Paragraph (1) shall not apply in the case of a vitamin, min-
eral, other ingredient of food, or food, which is represented for use
by individuals in the treatment or management of specific diseases
or disorders, by children, or by pregnant or lactating women. For
purposes of this subparagraph x, the term "children" means individ-
uals who are under the age of twelve years.
(b)(l) A food to which this section applies shall not be deemed
under section 403 to be misbranded solely because its label bears,
in accordance with section 403(i)(2), all the ingredients in the food
or its advertising contains references to ingredients in the food
which are not vitamins or minerals.
(2) The labeling for any food to which this section applies may
not list its ingredients which are not dietary supplement ingredi-
ents described in section 201(fF) (i) except as a part of a list of all
the ingredients of such food, and (ii) unless such ingredients are
listed in accordance with applicable regulations under section 403.
To the extent that compliance with clause (i) of this subparagraph
is impracticable or results in deception or unfair competition, ex-
emptions shall be established by regulations promulgated by the
Secretary.
(c)(l) For purposes of this section, the term "food to which this
section applies" means a food for humans which is a food for spe-
cial dietary use—
(A) which is or contains any natural or synthetic vitamin
or mineral, and
(B) which—
(i) is intended for ingestion in tablet, capsule, powder,
softgel, gelcap, or liquid form, or
(ii) if not intended for ingestion in such a form, is not
represented as conventional food and is not represented for
use as a sole item of a meal or of the diet.
(2) For purposes of paragraph (l)(B)(i), a food shall be consid-
ered as intended for ingestion in liquid form only if it is formulated
in a fluid carrier and it is intended for ingestion in daily quantities
measured in drops or similar small units of measure.
(3) For purposes of paragraph (1) and of section 403 (j) insofar
as that section is applicable to food to which this section applies,
the term "special dietary use" as applied to food used by man
means a particular use for which a food purports or is represented
to be used, including but not limited to the following:
(A) Supplying a special dietary need that exists by reason
of a physical, physiological, pathological, or other condition, in-
cluding but not limited to the condition of disease, convales-
1 Probably should be "paragraph".
-------
183 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 412
cence, pregnancy, lactation, infancy, allergic hypersensitivity to
food, underweight, overweight, or the need to control the in-
take of sodium.
(B) Supplying a vitamin, mineral, or other ingredient for
use by man to supplement his diet by increasing the total die-
tary intake.
(C) Supplying a special dietary need by reason of being a
food for use as the sole item of the diet.
REQUIREMENTS FOR INFANT FORMULAS
SEC. 412. [350a] (a) An infant formula, including an infant
formula powder, shall be deemed to be adulterated if—
(1) such infant formula does not provide nutrients as re-
quired by subsection (i),
(2) such infant formula does not meet the quality factor re-
quirements prescribed by the Secretary under subsection (b)(l),
or
(3) the processing of such infant formula is not in compli-
ance with the good manufacturing practices and the quality
control procedures prescribed by the Secretary under sub-
section (b)(2).
(b)(l) The Secretary shall by regulation establish requirements
for quality factors for infant formulas to the extent possible consist-
ent with current scientific knowledge, including quality factor re-
quirements for the nutrients required by subsection (i).
(2)(A) The Secretary shall by regulation establish good manu-
facturing practices for infant formulas, including quality control
procedures that the Secretary determines are necessary to assure
that an infant formula provides nutrients in accordance with this
subsection and subsection (i) and is manufactured in a manner de-
signed to prevent adulteration of the infant formula.
(B) The good manufacturing practices and quality control pro-
cedures prescribed by the Secretary under subparagraph (A) shall
include requirements for—
(i) the testing, in accordance with paragraph (3) and by the
manufacturer of an infant formula or an agent of such manu-
facturer, of each batch of infant formula for each nutrient re-
quired by subsection (i) before the distribution of such batch,
(ii) regularly scheduled testing, by the manufacturer of an
infant formula or an agent of such manufacturer, of samples
of infant formulas during the shelf life of such formulas to en-
sure that such formulas are in compliance with this section,
(iii) in-process controls including, where necessary, testing
required by good manufacturing practices designed to prevent
adulteration of each batch of infant formula, and
(iv) the conduct by the manufacturer of an infant formula
or an agent of such manufacturer of regularly scheduled audits
to determine that such manufacturer has complied with the
regulations prescribed under subparagraph (A).
In prescribing requirements for audits under clause (iv), the Sec-
retary shall provide that such audits be conducted by appropriately
trained individuals who do not have any direct responsibility for
the manufacture or production of infant formula.
-------
Sec. 412 FEDERAL FOOD, DRUB, AND COSMETIC ACT 184
(3)(A) At the final product stage, each batch of infant formula
shall be tested for vitamin A, vitamin Bl, vitamin C, and vitamin
E to ensure that such infant formula is in compliance with the re-
quirements of this subsection and subsection (i) relating to such vi-
tamins.
(B) Each nutrient premix used in the manufacture of an infant
formula shall be tested for each relied upon nutrient required by
subsection (i) which is contained in such premix to ensure that
such premix is in compliance with its specifications or certifications
by a premix supplier.
(C) During the manufacturing process or at the final product
stage and before distribution of an infant formula, an infant for-
mula shall be tested for all nutrients required to be included in
such formula by subsection (i) for which testing has not been con-
ducted pursuant to subparagraph (A) or (B). Testing under this
subparagraph shall be conducted to—
(i) ensure that each batch of such infant formula is in com-
pliance with the requirements of subsection (i) relating to such
nutrients, and
(ii) confirm that nutrients contained in any nutrient pre-
mix used in such infant formula are present in each batch of
such infant formula in the proper concentration.
(D) If the Secretary adds a nutrient to the list of nutrients in
the table in subsection (i), the Secretary shall by regulation require
that the manufacturer of an infant formula test each batch of such
formula for such new nutrient in accordance with subparagraph
(A), (B), or (C).
(E) For purposes of this paragraph, the term "final product
stage" means the point in the manufacturing process, before dis-
tribution of an infant formula, at which an infant formula is ho-
mogenous and is not subject to further degradation.
(4)(A) The Secretary shall by regulation establish requirements
respecting the retention of records. Such requirements shall pro-
vide for—
(i) the retention of all records necessary to demonstrate
compliance with the good manufacturing practices and quality
control procedures prescribed by the Secretary under para-
graph (2), including records containing the results of all testing
required under paragraph (2)(B),
(ii) the retention of all certifications or guarantees of anal-
ysis by premix suppliers,
(iii) the retention by a premix supplier of all records nec-
essary to confirm the accuracy of all premix certifications and
guarantees of analysis,
(iv) the retention of—
(I) all records pertaining to the microbiological quality
and purity of raw materials used in infant formula powder
and in finished infant formula, and
(II) all records pertaining to food packaging materials
which show that such materials do not cause an infant for-
mula to be adulterated within the meaning of section
402(a)(2)(0,
-------
185 FEDERAL FOOD, DRUG, AND COSMETIC ACT Sec. 412
(v) the retention of all records of the results of regularly
scheduled audits conducted pursuant to the requirements pre-
scribed by the Secretary under paragraph (2)(B)(iv), and
(vi) the retention of all complaints and the maintenance of
files with respect to, and the review of, complaints concerning
infant formulas which may reveal the possible existence of a
hazard to health.
(B)(i) Records required under subparagraph (A) with respect to
an infant formula shall be retained for at least one year after the
expiration of the shelf life of such infant formula. Except as pro-
vided in clause (ii), such records shall be made available to the Sec-
retary for review and duplication upon request of the Secretary.
(ii) A manufacturer need only provide written assurances to
the Secretary that the regularly scheduled audits required by para-
graph (2)(B)(iv) are being conducted by the manufacturer, and need
not make available to the Secretary the actual written reports of
such audits.
(c)(l) No person shall introduce or deliver for introduction into
interstate commerce any new infant formula unless—
(A) such person has, before introducing such new infant
formula, or delivering such new infant formula for introduc-
tion, into interstate commerce, registered with the Secretary
the name of such person, the place of business of such person,
and all establishments at which such person intends to manu-
facture such new infant formula, and
(B) such person has at least 90 days before marketing such
new infant formula, made the submission to the Secretary re-
quired by subsection (c)(l).
(2) For purposes of paragraph (1), the term "new infant for-
mula" includes—
(A) an infant formula manufactured by a person which has
not previously manufactured an infant formula, and
(B) an infant formula manufactured by a person which has
previously manufactured infant formula and in which there is
a major change, in processing or formulation, from a current
or any previous formulation produced by such manufacturer.
For purposes of this paragraph, the term "major change" has the
meaning given to such term in section 106.30(c)(2) of title 21, Code
of Federal Regulations (as in effect on August 1, 1986), and guide-
lines issued thereunder.
(d)(l) A person shall, with respect to any infant formula sub-
ject to subsection (c), make a submission to the Secretary which
shall include—
(A) the quantitative formulation of the infant formula,
(B) a description of any reformulation of the formula or
change in processing of the infant formula,
(C) assurances that the infant formula will not be mar-
keted unless it meets the requirements of subsections (b)(l)
and (i), as demonstrated by the testing required under sub-
section (b)(3), and
(D) assurances that the processing of the infant formula
complies with subsection (b)(2).
(2) After the first production of an infant formula subject to
subsection (c), and before the introduction into interstate commerce
-------
Sec. 412 FEDERAL FOOD, DRUG, AND COSMETIC ACT 186
of such formula, the manufacturer of such formula shall submit to
the Secretary, in such form as may be prescribed by the Secretary,
a written verification which summarizes test results and records
demonstrating that such formula complies with the requirements of
subsections (b)(l), (b)(2)(A), (b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A),
(b)(3)(C), and (i).
(3) If the manufacturer of an infant formula for commercial or
charitable distribution for human consumption determines that a
change in the formulation of the formula or a change in the proc-
essing of the formula may affect whether the formula is adulter-
ated under subsection (a), the manufacturer shall, before the first
processing of such formula, make the submission to the Secretary
required by paragraph (1).
(e)(l) If the manufacturer of an infant formula has knowledge
which reasonably supports the conclusion that an infant formula
which has been processed by the manufacturer and which has left
an establishment subject to the control of the manufacturer—
(A) may not provide the nutrients required by subsection
(i), or
(B) may be otherwise adulterated or misbranded,
the manufacturer shall promptly notify the Secretary of such
knowledge. If the Secretary determines that the infant formula pre-
sents a risk to human health, the manufacturer shall immediately
take all actions necessary to recall shipments of such infant for-
mula from all wholesale and retail establishments, consistent with
recall regulations and guidelines issued by the Secretary.
(2) For purposes of paragraph (1), the term "knowledge" as ap-
plied to a manufacturer means (A) the actual knowledge that the
manufacturer had, or (B) the knowledge which a reasonable person
would have had under like circumstances or which would have
been obtained upon the exercise of due care.
(f)(l) If a recall of infant formula is begun by a manufacturer,
the recall shall be carried out in accordance with such require-
ments as the Secretary shall prescribe under paragraph (2) and—
(A) the Secretary shall, not later than the 15th day after
the beginning of such recall and at least once every 15 days
thereafter until the recall is terminated, review the actions
taken under the recall to determine whether the recall meets
the requirements prescribed under paragraph (2), and
(B) the manufacturer shall, not later than the 14th day
after the beginning of such recall and at least once every 14
days thereafter until the recall is terminated, report to the Sec-
retary the actions taken to implement the recall.
(2) The Secretary shall by regulation prescribe the scope and
extent of recalls of infant formulas necessary and appropriate for
the degree of risks to human health presented by the formula sub-
ject to the recall.
(3) The Secretary shall by regulation require each manufac-
turer of an infant formula who begins a recall of such formula be-
cause of a risk to human health to request each retail establish-
ment at which such formula is sold or available for sale to post at
the point of purchase of such formula a notice of such recall at such
establishment for such time that the Secretary determines nec-
essary to inform the public of such recall.
-------
187 FEDERAL FOOD, DRUB, AND COSMETIC ACT Sec. 412
(g)(l) Each manufacturer of an infant formula shall make and
retain such records respecting the distribution of the infant for-
mula through any establishment owned or operated by such manu-
facturer as may be necessary to effect and monitor recalls of the
formula. Such records shall be retained for at least one year after
the expiration of the shelf life of the infant formula.
(2) To the extent that the Secretary determines that records
are not being made or maintained in accordance with paragraph
(1), the Secretary may by regulation prescribe the records required
to be made under paragraph (1) and requirements respecting the
retention of such records under such paragraph. Such regulations
shall take effect on such date as the Secretary prescribes but not
sooner than the 180th day after the date such regulations are pro-
mulgated. Such regulations shall apply only with respect to dis-
tributions of infant formulas made after such effective date.
(h)(l) Any infant formula which is represented and labeled for
use by an infant—
(A) who has an inborn error of metabolism or a low birth
weight, or
(B) who otherwise has an unusual medical or dietary prob-
lem,
is exempt from the requirements of subsections (a), (b), and (c). The
manufacturer of an infant formula exempt under this paragraph
shall, in the case of the exempt formula, be required to provide the
notice required by subsection (e)(l) only with respect to adultera-
tion or misbranding described in subsection (e)(l)(B) and to comply
with the regulations prescribed by the Secretary under paragraph
(2).
(2) The Secretary may by regulation establish terms and condi-
tions for the exemption of an infant formula from the requirements
of subsections (a), (b), and (c). An exemption of an infant formula
under paragraph (1) may be withdrawn by the Secretary if such
formula is not in compliance with applicable terms and conditions
prescribed under this paragraph.
(i)(l) An infant formula shall contain nutrients in accordance
with the table set out in this subsection or, if revised by the Sec-
retary under paragraph (2), as so revised.
(2) The Secretary may by regulation—
(A) revise the list of nutrients in the table in this sub-
section, and
(B) revise the required level for any nutrient required by
the table.
-------
Sec. 413 FEDERAL FOOD, DRU6. AND COSMETIC ACT 188
NUTRIENTS
Nutrient Minimum1 Maximum1
Protein (gin) 1.82 4.5.
Fat:
gm 3.3 6.0.
percent cal 30.0 54.0.
Essential fatty acids (linoleate):
percent cal 2.7
mg 300.0
Vitamins:
A (IU) 250.0 (75 ng)3 750.0 (225 fig).3
D (IU) 40.0 100.0.
K(ug) 4.0
E (ID) 0.7 (with 0.7 lU/gm linoleic
acid).
C (ascorbic acid) (mg) 8.0
Bi (thiamine) (jig) 40.0
B2 (riboflavin) (ng) 60.0
B6 (pyridoxine) (|ig) 35.0 (with 15 ug/gm of pro-
tein in formula).
B.2 (H«> -, g-16
Niacm (ug) 250.0
cid (u
Folic acid (ng) 4.0
Pantothenic acid (ug) 300.0
Biotin (fig) 1.54
Choline (mg) 7.04
Inositol (mg) 4.04
Minerals:
Calcium (mg) 50.05
Phosphorus (mg) 25.05
Magnesium (mg) 6.0
Iron (mg) 0.15
Iodine ((ig) 5.0
Zinc (mg) 0.5
CopperTug) 60.0
Manganese (tig) 5.0
Sodium (mg) 20.0 60.0.
Potassium (mg) 80.0 200.0.
Chloride (mg) 55.0 150.0.
'Stated per 100 kilocalories.
2 The source of protein shall be at least nutritionally equivalent to casein.
3Retinol equivalents.
4 Required to be included in this amount only in formulas which are not milk-based.
6 Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0.
NEW DIETARY INGREDIENTS
SEC. 413. [350b] (a) IN GENERAL.—A dietary supplement
which contains a new dietary ingredient shall be deemed adulter-
ated under section 402(f) unless it meets one of the following re-
quirements:
(1) The dietary supplement contains only dietary ingredi-
ents which have been present in the food supply as an article
used for food in a form in which the food has not been chemi-
cally altered.
(2) There is a history of use or other evidence of safety es-
tablishing that the dietary ingredient when used under the
conditions recommended or suggested in the labeling of the di-
etary supplement will reasonably be expected to be safe and,
at least 75 days before being introduced or delivered for intro-
duction into interstate commerce, the manufacturer or dis-
tributor of the dietary ingredient or dietary supplement pro-
vides the Secretary with information, including any citation to
-------
189 FEDERAL FOOD, DRU6, AND COSMETIC ACT Sec. 413
published articles, which is the basis on which the manufac-
turer or distributor has concluded that a dietary supplement
containing such dietary ingredient will reasonably be expected
to be safe.
The Secretary shall keep confidential any information provided
under paragraph (2) for 90 days following its receipt. After the ex-
piration of such 90 days, the Secretary shall place such information
on public display, except matters in the information which are
trade secrets or otherwise confidential, commercial information.
(b) PETITION.—Any person may file with the Secretary a peti-
tion proposing the issuance of an order prescribing the conditions
under which a new dietary ingredient under its intended conditions
of use will reasonably be expected to be safe. The Secretary shall
make a decision on such petition within 180 days of the date the
petition is filed with the Secretary. For purposes of chapter 7 of
title 5, United States Code, the decision of the Secretary shall be
considered final agency action.
(c) DEFINITION.—For purposes of this section, the term "new di-
etary ingredient" means a dietary ingredient that was not mar-
keted in the United States before October 15, 1994 and does not
include any dietary ingredient which was marketed in the United
States before October 15, 1994.
.S GOVERNMENT PRINTING OFFICE: 1998 615-003/60633
------- |