« PreviousContinue »
& 162.1 Words in singular form.
and mildew and mold preventatives, and Words used in the singular form in this
(2) Disinfectants, sanitizers, and sterpart shall include the plural, and vice ilizers, except those for use only on or
in living man or other animals. versa, as the case may require.
(f) Herbicide. “Herbicide" means any $ 162.2 Terms defined.
substance or mixture of substances in. Terms used in this part shall have the tended for preventing, destroying, remeanings set forth for such terms in the
pelling, or mitigating any weed, includAct. In addition, as used in this part,
ing any algae or other aquatic weed, or the following terms shall have the mean- any plant parts growing where not ings stated below:
wanted. (a) Act. “Act" means the Federal In
(g) Nematocide. "Nematocide” insecticide, Fungicide, and Rodenticide cludes only those products intended for Act, as amended.
preventing, destroying, repelling, or (b) Director. "Director” means the mitigating nematodes inhabiting soil, Director of the Pesticides Regulation Di
water, plants, or plant parts. The term vision, Environmental Protection Agency,
does not include products intended for or any officer or employee to whom
use against nematodes in or on living he has heretofore lawfully delegated or
man or other animals. to whom he may hereafter lawfully del
(h) Plant regulator. “Plant regulaegate the authority to act in his stead.
tor" includes those substances intended (c) Agency. "Agency” means the En
to alter the behavior of ornamental or vironmental Protection Agency.
crop plants or the produce thereof (d) Economic poison. "Economic pol
through physiological rather than physison" includes all preparations intended
cal action. The term includes, but is not for use as insecticides, rodenticides, nem
limited to, substances intended to acatocides, fungicides, herbicides, amphib
celerate or retard the rate of growth or ian and reptile poisons or repellents,
maturation of ornamental or crop plants, bird poisons or repellents, fish poisons or
enhance fruit set, prevent fruit drop, repellents, mammal poisons or repellents,
accelerate root formation and elongation, invertebrate animal poisons or repellents,
prolong or break domancy of ornaplant regulators, plant defoliants, and
mental or crop plants or the produce plant desiccants. A product shall be
thereof, but shall not include substances deemed to be an economic poison regard
Intended solely for use as plant nutrients less of whether intended for use as pack
or fertilizers. aged or after dilution or mixture with
(1) Active ingredient. An "active inother substances, such as carriers or
gredient” is an ingredient which: (1) Is baits. Products intended only for use
capable in itself, and when used in the after further processing or manufactur
same manner and for the same purposes ing, such as grinding to dust or more ex
as directed for use of the product, of tensive operations, shall not be deemed
preventing, destroying, repelling, or to be economic poisons. Substances
mitigating insects, fungi, ro its, weeds, which have recognized commercial uses
nematodes, or other pests, or altering other than uses as economic poisons shall
through physiological action the benot be deemed to be economic poisons
havior of ornamental or crop plants or unless such substances are:
the produce thereof, or causing leaves or (1) Specially prepared for use as eco
foilage to drop from a plant, or artinomic poisons, or
ficially accelerating the drying of plant (2) Labeled, represented, or intended
tissue. for use as economic poisons, or
(2) Is present in the product in an (3) Marketed in channels of trade
amount sufficient to add materially to its where they will presumably be pur
effectiveness; and chased as economic poisons.
(3) Is not antagonistic to the activity (e) Fungicide. "Fungicide" includes
of the principal active ingredient: Pro
vided, however, That the Director may all preparations intended for preventing,
require an ingredient to be designated as destroying, repelling, or mitigating any
an active ingredient if, in his opinion, it fungi or any viruses (other than those on
suficiently increases the effectiveness of or in living man or other animals). Ex
the economic poison to warrant such amples of fungicides include but are not action. limited to: (1) Plant fungicides, seed (j) Oficial inspector. “Official infungicides, fungicidal wood preservatives, spector" means any employee or agent of
the Environmental Protection Agency or $ 162.9. The label or labeling of every the Treasury Department authorized by economic poison must bear directions for the Director or by the Secretary of the use which are necessary and if complied Treasury to make investigations in con- with, adequate for the protection of the nection with enforcement of the Act. public.
(k) Vertebrate animals. “Vertebrate (b) Placement of label. The label animals" means all species of the sub- shall appear on the economic poison or phylum vertebrata including domestic the immediate container thereof. If the vertebrates and vertebrate species of fish immediate container is enclosed within and wildlife.
a wrapper or outside container through (1) Invertebrate animals. "Inverte- which the label cannot be clearly read brate animals" means all forms of ani. by a person with normal vision, the label mal life other than vertebrate animals, must also appear on such outside wrapincluding both domestic and wild species. per or container if it is a part of the
retail package. § 162.3 Administration.
(c) Name and address of manufacThe Director is authorized to take such turer, distributor, packer, formulator, or action as, in his discretion, may be nec- registrant. An unqualified name and adessary in the administration and enforce- dress given on the label shall be conment of the Act and the regulations in sidered as the name and address of the this part.
manufacturer. If the registrant's name LABELING
appears on the label and the registrant $ 162.4 Labeling required.
is not the manufacturer, or if the name
of the person for whom the economic Every economic poison shall bear a
poison was manufactured appears on the label containing the information specified label, it must be qualified by appropriate in the Act and the regulations in this wording such as "Packed for part.
or "Sold by § 162.5 Language to be used.
*" to show that the name is not
that of the manufacturer. If a person All statements, words, and other in
has two or more locations at which an formation required by the Act or the reg
economic poison is manufactured or ulations in this part to appear on the
packaged, or from which it is distributed, label or labeling of any economic polson
the name and address of the person's shall be in the English language: Provid
principal office will be accepted exed, That shipments of articles intended
cept in cases where the Director desolely for sale in foreign countries may
termines that the address of the exact bear labels or labeling in the appropriate location is necessary for the protection foreign language. The Director may
of the public. The address of the manupermit the use of an appropriate foreign
facturer, registrant, or person for whom language version of the label or labeling
manufactured shall include the street in addition to the English version on
address, if any, unless the street address products intended for distribution in
is shown in a current city directory or areas of the United States where a large
telephone directory. percentage of the population does not
(d) Name, brand, or trade-mark of speak English.
economic poison. The name, brand, or $ 162.6 Labeling.
trade-mark of the economic poison, ap
pearing on the label shall be that under (a) Contents of label and labeling.
which the economic poison is registered. The label of every economic poison must show, clearly and prominently, the name,
(e) Net content. (1) The net content
shall be exclusive of wrappers or other brand or trademark under which the
material, and shall be deemed to be averproduct is sold; the name and address of
age content unless stated as a minimum the manufacturer, registrant, or person quantity. for whom manufactured; the net con- (2) Net content shall be stated in the tents as prescribed in paragraph (e) terms of weight or measure in general of this section; an ingredient statement use by consumers and users of the type as prescribed in § 162.7; the registration of economic poison to give accurate innumber assigned to the economic poison formation as to the quantity of the ecoas prescribed in paragraph (f) of this nomic poison. If there is no general use section, and an appropriate warning or the net content statement shall be in caution statement as prescribed in terms of liquid measure if the product is
a liquid, and in terms of weight if it is solid, semi-solid, viscous, or a mixture of liquid and solid. Statements of liquid measure shall be in terms of the United States gallon, quart, pint, and fluid ounce at 68° F. The statements of weight shall be in terms of avoirdupois pound and ounce. All statements of net content shall be in terms of the largest unit present.
(3) If the contents are stated as a minimum quantity, variation below the stated quantity is not permissible and variation above shall not be unreasonably large.
(4) If the contents are not stated as a minimum quantity, variation shall be permitted only to the extent that it represents deviations unavoidable in good packing practice. The average quantity in the packages in a shipment shall not fall below the average quantity stated, nor shall there be any unreasonable variation from the average in the contents of any package.
(f) Registration number. The registration number assigned to an economic poison at the time of registration shall appear on the label of such economic poison. The number must be the same as that appearing on the notice of registration and shall be preceded by the phrase "EPA Registration No.," or the phrase "EPA Reg. No.” all of which shall be in type of a size and style similar to other print on that part of the label on which it appears and shall run parallel to it. The registration number shall not appear in a manner which would make it misleading to the public.
(g) Legibility of label and labeling. All words, statements, graphic representations, or designs required by the regulations in this part to appear on the label or labeling must be clearly legible and easy to read by a person with normal vision. The signal word, when required, and the statement "Keep out of reach of children" prescribed in $ 162.9(a) shall be of a size bearing a reasonable relationship to the other type on the front part of the label and to the size of the container. The signal word, when required, shall not be less than 18 point type and the said warning statement shall not be less than 12 point type, unless the label space on the container is too small to accommodate such type sizes in which case the Director shall prescribe the type size. When the size of the label space requires a reduction in type size, the reduction shall be made to a size no smaller
than is necessary and in no event to a size smaller than 6 point type. 8 162.7 Ingredient statement.
(a) Location of ingredient statement. The ingredient statement must appear on the front panel or that part of the label displayed under customary conditions of purchase, except in cases where the Director determines that, due to the size or form of the container, a statement on that portion of the label is impracticable, and permits such statement to appear on another side or panel of the label. Regardless of the placement of the ingredient statement on the label, it shall be sufficiently prominent and in type size which can be easily read by a person with normal vision. The ingredient statement must run parallel with other printed matter on the panel of the label on which it appears and must be on a clear contrasting background not obscured or crowded.
(b) Names of ingredients. The wellknown common name of each of the listed ingredients must be given or, if an ingredient has no common name, the correct chemical name which conforms most closely with generally accepted rules of chemical nomenclature. If there is no common name and the chemical composition is complex, the Director may permit the use of a new or coined name which he finds to be appropriate for the information and protection of the user. If the use of a new or coined name is permitted, the Director may prescribe the terms under which it may be used. A trade-mark or trade name shall not be used as the name of an ingredient except when it has become a common name.
(c) Percentages of ingredients. Percentages of ingredients shall be determined by weight and the sum of the percentages of the ingredients shall be 100. Sliding scale forms of ingredient statements shall not be used.
(d) Designation of ingredients. (1) Active ingredients and inert ingredients shall be so designated, and the term "inert ingredients" shall appear in the same size type and be equally as prominent as the term "active ingredients.”
(2) If the name but not the percentage of each active ingredient is given, the names of the active and inert ingredients shall, respectively, be shown in the descending order of the percentage of each present in each classification and the name of each ingredient shall be given equal prominence.
(e) Active ingredient content. As long whether an economic poison is highly as an economic poison is subject to the toxic to man. Act the percentages of active ingredients (c) Terms LDs, and LC80. An LD. As in the economic poison shall be those used in connection with oral toxicity and declared in the ingredient statement. skin absorption toxicity tests specified $ 162.8 Economic poisons highly toxic
in paragraph (a) (1) and (3) of this
section is the dose and LCso as used in to man.
connection with inhalation tests speci. (a) Economic poisons which fall with
fied in paragraph (a) (2) of this section in any of the following categories when
is the concentration which is expected tested on laboratory animals as speci
to cause death within 14 days in 50 perfied in subparagraphs (1), (2), or (3)
cent of the test animals so treated. of this paragraph are highly toxic to
(d) Toxicity based on human experi. man or contain substances or quantities
ence. If the Director finds, after opof substances highly toxic to man within
portunity for hearing, that available the meaning of the Act (such economic
data on human experience with any poisons being hereinafter in this part
economic poison indicate & toxicity referred to as economic poisons highly
greater than that determined from the toxic to man): Provided, however, That
above described tests on animals, the the Director may, upon application and
human data shall take precedence and, after opportunity for hearing, exempt
if he finds that the protection of the any economic poison which is in any
public so requires the Director shall deof these categories, but which is not in clare such an economic poison to be fact highly toxic to man, from the re- highly toxic to man for the purposes of quirements of the Act and the regula- this Act and the regulations thereunder. tions in this part with respect to economic poisons highly toxic to man:
$ 162.9 Warning or caution statement. (1) Oral toxicity. An economic poi- Warning or caution statements, which son which has a single dose LD50 of 50 are necessary and, if complied with, ademilligram or less per kilogram of body quate to prevent injury to living man weight when administered orally to both
and useful vertebrate animals, useful male and female rats which have been vegetation, and useful invertebrate anifasted for a period of 24 hours (or to
mals, must appear on the label in a place other rodent or nonrodent species speci
sufficiently prominent to warn the user fied by the Director); or
and must state clearly and in nontechni. (2) Toxicity 0.2 inhalation. An eco
cal language the particular hazard in
volved in the use of the economic poison, nomic poison which has an LCso of 2,000 micrograms or less of dust or mist per
e.g., ingestion, skin absorption, Inhalaliter of air or 200 parts per million or
tion, flammability or explosion, and the less by volume of a gas or vapor, when
precautions to be taken to avoid accident, administered by continuous inhalation
injury, or damage. for one hour to both male and female
(a) The label of every economic pol
son shall bear warnings or cautions rats (or to other rodent or nonrodent
which are necessary for the protection of species specified by the Director), if the
the public, including the statement, Director finds that it is reasonably foreseeable that such concentration will be
"Keep out of reach of children," and a
signal word such as “Danger," "Warnencountered by man; or
ing," or "Caution" as the Director may (3) Toricity by skin absorption. An
prescribe, on the front panel or that part economic poison which has an LDs of
of the label displayed under customary 200 milligrams or less per kilogram of
conditions of purchase: Provided, howbody weight when administered by con
ever, The Director may permit reasontinuous contact for twenty-four hours
able variations in the placement of that with the bare skin of rabbits (or other
part of the required warnings and caurodent or nonrodent species specified by
tions other than the statement “Keep out the Director).
of reach of children" and the required (b) Tests on other species. Tests on
signal word, if in his opinion such varlother specified rodent or nonrodent ations would not be injurious to the species may be required by the Director
public. If an economic poison is marwith respect to individual economic poi. keted in channels of trade where the likesons or to classes of economic poisons lihood of contact with children is exwhenever he finds that tests on other tremely remote, or if the nature of the species are necessary to determine product is such that it is likely to be used
on infants or small children without requested by the Director, a full descripcausing injury under any reasonably tion of the tests made and the results foreseeable conditions, the Director may thereof upon which the claims for the waive the requirement of the statement economic poison are based, together with "Keep out of reach of children" if in his such other information as may be necesopinion such a statement is not necessary sary to assure compliance with the Act to prevent injury to the public. The Di- and the regulations in this part. If any rector may permit a statement such as
part of the proposed labeling submitted "Keep away from infants and small chil
is in a foreign language, it shall be acdren" in lieu of the statement "Keep out
companied by an accurate and complete of reach of children" if he determines
English translation. Applications should that such a variation would not be in
be submitted as far in advance as posjurious to the public.
sible, and at least 30 days, before it is (b) The label of every economic pol
desired that registration take effect. son which is highly toxic to man as de
However, the period of time required to scribed in $ 162.8 shall bear the word “Danger" along with the word “Poison"
process applications to determine the in red on a contrasting background in
adequacy of the proposed labeling may immediate proximity to the skull and
exceed 30 days in some cases. Applicacrossbones and an antidote statement in
tions which require consultation with cluding directions to call a physician im- other governmental agencies will take & mediately, on the front panel or that
longer period of processing. No fees are part of the label displayed under custom
charged for registration. ary conditions of purchase: Provided,
(d) Registration number. When an however, The Director may permit rea- economic poison is registered under the sonable variations in the placement of Act, the Director shall assign a registrethe antidote statement if some refer- tion number to the economic poison. ence such as “See antidote statement on The registration number shall consist of back panel" appears on the front panel a number assigned to the registrant, imnear the word “Poison" and the skull mediately followed by a hyphen and a and crossbones.
number assigned to the product. For dis
tributor products marketed under supREGISTRATION
plemental registration, the product num$ 162.10 Registration.
ber must be followed by a hyphen and the (a) Eligibility. Any manufacturer, number assigned to the distributor. This packer, seller, distributor, or shipper of may also include a letter designation of an economic polson is eligible to apply revised or amended registration as refor registration of such economic poison. quired by State law.
(b) Effect of registration. If an eco- (e) Efective date of registration. nomic poison is registered under the Act Registration of an economic poison shall no further registration under the Act by become effective on the date the notice other persons is required: Provided, That of registration is issued.
(1) The product is in the manufac- (f) Responsibility of applicant for regturer's or registrant's original unbroken istration. The applicant for registration immediate container; and
is responsible for the accuracy and com(2) The claims made for it and the pleteness of all information submitted directions for its use do not differ from in connection with his application for the representations made in connection registration of an economic poison. with registration; and
(g) Changes in labeling or formulas. (3) The product contains the labeling
(1) Changes in the labeling or changes accepted in connection with registration
in the formula of a registered economic and otherwise complies with the Act.
poison must be submitted in advance to (c) Procedure for registration. Appli
the Pesticides Regulation Division, Encations for registration should be ad
vironmental Protection Agency, Washdressed to Pesticides Regulation Division,
ington, D.C. 20250. The registrant must
describe the exact changes desired and Environmental Protection Agency, Washington, D.C., 20250. Application forms
the proposed effective date and, upon rewill be furnished upon request. All ap
quest, shall submit a description of tests plications for registration shall be ac
which justify such changes. companied by duplicate copies of the
(2) After the effective date of a change proposed labeling, including all printed
in labeling or formula, the product shall or graphic matter which is to accompany
be marketed only under the new claims the economic poison at any time and, or formula: Provided, however, The Di