|
U.S. Code as of:
01/03/05
Section 136. Definitions
For purposes of this subchapter -
(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;
(4) in the case of a desiccant, an ingredient which will
artificially 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 Administrator of the
Environmental Protection Agency.
(c) Adulterated
The term "adulterated" applies to any pesticide if -
(1) its strength or purity falls below the professed standard
of quality as expressed on its labeling under which it is sold;
(2) any substance has been substituted wholly or in part for
the pesticide; or
(3) any valuable constituent of the pesticide has been wholly
or in part abstracted.
(d) Animal
The term "animal" means all vertebrate and invertebrate species,
including but not limited to man and other mammals, birds, fish,
and shellfish.
(e) Certified applicator, etc.
(1) Certified applicator
The term "certified applicator" means any individual who is
certified under section 136i of this title as authorized to use
or supervise the use of any pesticide which is classified for
restricted use. Any applicator who holds or applies registered
pesticides, or uses dilutions of registered pesticides consistent
with subsection (ee) of this section, only to provide a service
of controlling pests without delivering any unapplied pesticide
to any person so served is not deemed to be a seller or
distributor of pesticides under this subchapter.
(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 applied without compensation other
than trading of personal services between producers of
agricultural commodities) on the property of another person.
(3) Commercial applicator
The term "commercial applicator" means an applicator (whether
or not the applicator is a private applicator with respect to
some uses) who uses or supervises the use of any pesticide which
is classified for restricted use for any purpose or on any
property other than as provided by paragraph (2).
(4) Under the direct supervision of a certified applicator
Unless otherwise prescribed by its labeling, a pesticide shall
be considered to be applied under the direct supervision of a
certified applicator if it is applied by a competent person
acting under the instructions and control of a certified
applicator who is available if and when needed, even though such
certified applicator is not physically present at the time and
place the pesticide is applied.
(f) Defoliant
The term "defoliant" means any substance of mixture of substances
intended for causing the leaves or foliage to drop from a plant,
with or without causing abscission.
(g) Desiccant
The term "desiccant" means any substance or mixture of substances
intended for artificially accelerating the drying of plant tissue.
(h) Device
The term "device" means any instrument or contrivance (other than
a firearm) which is intended for trapping, destroying, repelling,
or mitigating any pest or any other form of plant or animal life
(other than man and other than bacteria, virus, or other
microorganism on or in living man or other living animals); but not
including equipment used for the application of pesticides when
sold separately therefrom.
(i) District court
The term "district court" means a United States district court,
the District Court of Guam, the District Court of the Virgin
Islands, and the highest court of American Samoa.
(j) Environment
The term "environment" includes water, air, land, and all plants
and man and other animals living therein, and the
interrelationships which exist among these.
(k) Fungus
The term "fungus" means any non-chlorophyll-bearing thallophyte
(that is, any non-chlorophyll-bearing plant of a lower order than
mosses and liverworts), as for example, rust, smut, mildew, mold,
yeast, and bacteria, except those on or in living man or other
animals and those on or in processed food, beverages, or
pharmaceuticals.
(l) Imminent hazard
The term "imminent hazard" means a situation which exists when
the continued use of a pesticide during the time required for
cancellation proceeding would be likely to result in unreasonable
adverse effects on the environment or will involve unreasonable
hazard to the survival of a species declared endangered or
threatened by the Secretary pursuant to the Endangered Species Act
of 1973 [16 U.S.C. 1531 et seq.].
(m) Inert ingredient
The term "inert ingredient" means an ingredient which is not
active.
(n) Ingredient statement
The term "ingredient statement" means a statement which contains
-
(1) the name and percentage of each active ingredient, and the
total percentage of all inert ingredients, in the pesticide; and
(2) if the pesticide contains arsenic in any form, a statement
of the percentages of total and water soluble arsenic, calculated
as elementary arsenic.
(o) Insect
The term "insect" means any of the numerous small invertebrate
animals generally having the body more or less obviously segmented,
for the most part belonging to the class insecta, comprising
six-legged, usually winged forms, as for example, beetles, bugs,
bees, flies, and to other allied classes of anthropods whose
members are wingless and usually have more than six legs, as for
example, spiders, mites, ticks, centipedes, and wood lice.
(p) Label and labeling
(1) Label
The term "label" means the written, printed, or graphic matter
on, or attached to, the pesticide or device or any of its
containers or wrappers.
(2) Labeling
The term "labeling" means all labels and all other written,
printed, or graphic matter -
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature
accompanying the pesticide or device, except to current
official publications of the Environmental Protection Agency,
the United States Departments of Agriculture and Interior, the
Department of Health and Human Services, State experiment
stations, State agricultural colleges, and other similar
Federal or State institutions or agencies authorized by law to
conduct research in the field of pesticides.
(q) Misbranded
(1) A pesticide is misbranded if -
(A) its labeling bears any statement, design, or graphic
representation relative thereto or to its ingredients which is
false or misleading in any particular;
(B) it is contained in a package or other container or
wrapping which does not conform to the standards established by
the Administrator pursuant to section 136w(c)(3) of this title;
(C) it is an imitation of, or is offered for sale under the
name of, another pesticide;
(D) its label does not bear the registration number assigned
under section 136e of this title to each establishment in which
it was produced;
(E) any word, statement, or other information required by or
under authority of this subchapter to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or graphic matter in the labeling) and in such terms
as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and
use;
(F) the labeling accompanying it does not contain directions
for use which are necessary for effecting the purpose for which
the product is intended and if complied with, together with any
requirements imposed under section 136a(d) of this title, 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 136a(d) of this title, is
adequate to protect health and the environment; or
(H) in the case of a pesticide not registered in accordance
with section 136a of this title and intended for export, the
label does not contain, in words prominently placed thereon
with such conspicuousness (as compared with other words,
statements, designs, or graphic matter in the labeling) as to
render it likely to be noted by the ordinary individual under
customary conditions of purchase and use, the following: "Not
Registered for Use in the United States of America".
(2) A pesticide is misbranded if -
(A) the label does not bear an ingredient statement on that
part of the immediate container (and on the outside container
or wrapper of the retail package, if there be one, through
which the ingredient statement on the immediate container
cannot be clearly read) which is presented or displayed under
customary conditions or purchase, except that a pesticide is
not misbranded under this subparagraph 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 statement on the part
which is presented or displayed under customary conditions of
purchase; and
(ii) the ingredient statement appears prominently on
another part of the immediate container, or outside container
or wrapper, permitted by the Administrator;
(B) the labeling does not contain a statement of the use
classification under which the product is registered;
(C) there is not affixed to its container, and to the outside
container or wrapper of the retail package, if there be one,
through which the required information on the immediate
container cannot be clearly read, a label bearing -
(i) the name and address of the producer, registrant, or
person for whom produced;
(ii) the name, brand, or trademark under which the
pesticide is sold;
(iii) the net weight or measure of the content, except that
the Administrator may permit reasonable variations; and
(iv) when required by regulation of the Administrator to
effectuate the purposes of this subchapter, the registration
number assigned to the pesticide under this subchapter, 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 subchapter -
(i) the skull and crossbones;
(ii) the word "poison" prominently in red on a background
of distinctly contrasting color; and
(iii) a statement of a practical treatment (first aid or
otherwise) in case of poisoning by the pesticide.
(r) Nematode
The term "nematode" means invertebrate animals of the phylum
nemathelminthes and class nematoda, that is, unsegmented round
worms with elongated, fusiform, or saclike bodies covered with
cuticle, and inhabiting soil, water, plants, or plant parts; may
also be called nemas or eelworms.
(s) Person
The term "person" means any individual, partnership, association,
corporation, or any organized group of persons whether incorporated
or not.
(t) Pest
The term "pest" means (1) any insect, rodent, nematode, fungus,
weed, or (2) any other form of terrestrial or aquatic plant or
animal life or virus, bacteria, or other micro-organism (except
viruses, bacteria, or other micro-organisms on or in living man or
other living animals) which the Administrator declares to be a pest
under section 136w(c)(1) of this title.
(u) Pesticide
The term "pesticide" means (1) any substance or mixture of
substances intended for preventing, destroying, repelling, or
mitigating any pest, (2) any substance or mixture of substances
intended for use as a plant regulator, defoliant, or desiccant, and
(3) any nitrogen stabilizer, except that the term "pesticide" shall
not include any article that is a "new animal drug" within the
meaning of section 321(w) (!1) of title 21, that has been
determined by the Secretary of Health and Human Services not to be
a new animal drug by a regulation establishing conditions of use
for the article, or that is an animal feed within the meaning of
section 321(x) (!1) of title 21 bearing or containing a new animal
drug. The term "pesticide" does not include liquid chemical
sterilant products (including any sterilant or subordinate
disinfectant claims on such products) for use on a critical or
semi-critical device, as defined in section 321 of title 21. For
purposes of the preceding sentence, the term "critical device"
includes any device which is introduced 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 mucous 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 improvement,
maintenance, survival, health, and propagation of plants, and as
are not for pest destruction and are nontoxic, nonpoisonous in the
undiluted packaged concentration.
(w) Producer and produce
The term "producer" means the person who manufactures, prepares,
compounds, propagates, or processes any pesticide or device or
active ingredient used in producing a pesticide. The term "produce"
means to manufacture, prepare, compound, propagate, or process any
pesticide or device or active ingredient used in producing a
pesticide. The dilution by individuals of formulated pesticides for
their own use and according to the directions on registered labels
shall not of itself result in such individuals being included in
the definition of "producer" for the purposes of this subchapter.
(x) Protect health and the environment
The terms "protect health and the environment" and "protection of
health and the environment" mean protection against any
unreasonable adverse effects on the environment.
(y) Registrant
The term "registrant" means a person who has registered any
pesticide pursuant to the provisions of this subchapter.
(z) Registration
The term "registration" includes reregistration.
(aa) State
The term "State" means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust
Territory of the Pacific Islands, and American Samoa.
(bb) Unreasonable adverse effects on the environment
The term "unreasonable adverse effects on the environment" means
(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 346a of title 21. The
Administrator shall consider the risks and benefits of public
health pesticides separate from the risks and benefits of other
pesticides. In weighing any regulatory action concerning a public
health pesticide under this subchapter, the Administrator shall
weigh any risks of the pesticide 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 producing a pesticide is
produced, or held, for distribution or sale.
(ee) To use any registered pesticide in a manner inconsistent with
its labeling
The term "to use any registered pesticide in a manner
inconsistent with its labeling" means to use any registered
pesticide in a manner not permitted by the labeling, except that
the term shall not include (1) applying a pesticide at any dosage,
concentration, or frequency less than that specified on the
labeling unless the labeling specifically prohibits deviation from
the specified dosage, concentration, or frequency, (2) applying a
pesticide against any target pest not specified on the labeling if
the application is to the crop, animal, or site specified on the
labeling, unless the Administrator has required that the labeling
specifically state that the pesticide may be used only for the
pests specified on the labeling after the Administrator has
determined that the use of the pesticide against other pests would
cause an unreasonable adverse effect on the environment, (3)
employing any method of application not prohibited by the labeling
unless the labeling specifically states that the product may be
applied only by the methods specified on the labeling, (4) mixing a
pesticide or pesticides with a fertilizer when such mixture is not
prohibited by the labeling, (5) any use of a pesticide in
conformance with section 136c, 136p, or 136v of this title, or (6)
any use of a pesticide in a manner that the Administrator
determines to be consistent with the purposes of this subchapter.
After March 31, 1979, the term shall not include the use of a
pesticide for agricultural or forestry purposes at a dilution less
than label dosage unless before or after that date the
Administrator issues a regulation or advisory opinion consistent
with the study provided for in section 27(b) of the Federal
Pesticide Act of 1978, which regulation or advisory opinion
specifically requires the use of definite amounts of dilution.
(ff) Outstanding data requirement
(1) In general
The term "outstanding data requirement" means a requirement for
any study, information, or data that is necessary to make a
determination under section 136a(c)(5) of this title and which
study, information, or data -
(A) has not been submitted to the Administrator; or
(B) if submitted to the Administrator, the Administrator has
determined must be resubmitted because it is not valid,
complete, or adequate to make a determination under section
136a(c)(5) of this title and the regulations and guidelines
issued under such section.
(2) Factors
In making a determination under paragraph (1)(B) respecting a
study, the Administrator shall examine, at a minimum, relevant
protocols, documentation of the conduct and analysis of the
study, and the results of the study to determine whether the
study and the results of the study fulfill the data requirement
for which the study was submitted to the Administrator.
(gg) To distribute or sell
The term "to distribute or sell" means to distribute, sell, offer
for sale, hold for distribution, hold for sale, hold for shipment,
ship, deliver for shipment, release for shipment, or receive and
(having so received) deliver or offer to deliver. The term does not
include the holding or application of registered pesticides or use
dilutions thereof by any applicator who provides a service of
controlling pests without delivering any unapplied pesticide to any
person so served.
(hh) Nitrogen stabilizer
The term "nitrogen stabilizer" means any substance or mixture of
substances intended for preventing 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. - (!2)
(A) that was not registered pursuant to section 136a of this
title 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 volatilization (!3)
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 authority
to be included in the labeling or other literature accompanying any
such substance or mixture shall not be deemed a specific claim
within the meaning of this subsection.
(jj) (!4) Maintenance applicator
The term "maintenance applicator" 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 maintenance personnel,
sanitation personnel, and grounds maintenance personnel. The term
"maintenance applicator" does not include private applicators as
defined in subsection (e)(2) of this section; individuals who use
antimicrobial pesticides, sanitizers or disinfectants; individuals
employed by Federal, State, and local governments or any political
subdivisions thereof, or individuals who use pesticides not
classified for restricted use in or around their 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, sanitizers or
disinfectants; or who otherwise apply ready to use consumer
products pesticides.
(ll) Minor use
The term "minor use" means the use of a pesticide 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
registration or continuing registration of a pesticide for such
use and -
(A) there are insufficient efficacious alternative registered
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 significant
part in managing pest resistance; or
(D) the minor use pesticide plays or will play a significant
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
existing 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 -
(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 substances 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 346a of title 21 or a
food additive regulation under section 348 of title 21.
(2) Excluded products
The term "antimicrobial pesticide" does not include -
(A) a wood preservative or antifouling paint product for
which a claim of pesticidal activity other than or in addition
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 pesticide" does include any other
chemical sterilant product (other than liquid chemical sterilant
products exempt under subsection (u) of this section), any other
disinfectant product, any other industrial microbiocide product,
and any other preservative product that is not excluded by
paragraph (2).
(nn) Public health pesticide
The term "public health pesticide" means any minor use pesticide
product registered for use and used predominantly in public health
programs for vector control or for other recognized health
protection uses, including the prevention or mitigation of viruses,
bacteria, or other microorganisms (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.
|
|