[Code of Federal Regulations]
[Title 16, Volume 2]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1500.83]

[Page 473-479]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1500_HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS--Table of Contents
 
Sec. 1500.83  Exemptions for small packages, minor hazards, and special circumstances.

    (a) The following exemptions are granted for the labeling of 
hazardous substances under the provisions of Sec. 1500.82:
    (1) When the sole hazard from a substance in a self-pressurized 
container is that it generates pressure or when the sole hazard from a 
substance is that it is flammable or extremely flammable, the name of 
the component which contributes the hazards need not be stated.
    (2) Common matches, including book matches, wooden matches, and so-
called ``safety'' matches are exempt from the labeling requirements of 
section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar 
as they apply to the product being considered hazardous because of being 
``flammable'' or ``extremely flammable'' as defined in Sec. 
1500.3(c)(6)(iii) and (iv).
    (3) Paper items such as newspapers, wrapping papers, toilet and 
cleansing tissues, and paper writing supplies are exempt from the 
labeling requirements of section 2(p)(1) of the act (repeated in Sec. 
1500.3(b)(14)(i)) insofar as they apply to the products being considered 
hazardous because of being ``flammable'' or ``extremely flammable'' as 
defined in Sec. 1500.3(c)(6)(iii) and (iv).
    (4) Thread, string, twine, rope, cord, and similar materials are 
exempt from the labeling requirements of section 2(p)(1) of the act 
(repeated in Sec. 1500.3(b)(14)(i)) insofar as they apply to the 
products being considered hazardous because of being ``flammable'' or 
``extremely flammable'' as defined in Sec. 1500.3(c)(6) (iii) and (iv).
    (5) Laboratory chemicals intended only for research or 
investigational and other laboratory uses (except those in home 
chemistry sets) are exempt from the requirements of placement provided 
in Sec. 1500.121 if all information required by that section and the 
act appears with the required prominence on the label panel adjacent to 
the main panel.
    (6) [Reserved]
    (7) Rigid or semirigid ballpoint ink cartridges are exempt from the 
labeling requirements of section 2(p)(1) of the act (repeated in Sec. 
1500.3(b)(14)(i)), insofar as such requirements would be necessary 
because the ink contained therein is a ``toxic'' substance as defined in 
Sec. 1500.3(c)(2)(i), if:
    (i) The ballpoint ink cartridge is of such construction that the ink 
will, under any reasonably foreseeable conditions of manipulation or 
use, emerge only from the ballpoint end;
    (ii) When tested by the method described in Sec. 1500.3(c)(2)(i), 
the ink does not have an LD-50 single oral dose of less than 500 
milligrams per kilogram of body weight of the test animal; and
    (iii) The cartridge does not have a capacity of more than 2 grams of 
ink.
    (8) Containers of paste shoe waxes, paste auto waxes, and paste 
furniture and floor waxes containing toluene (also known as toluol), 
xylene (also known as xylol), petroleum distillates, and/or turpentine 
in the concentrations described in Sec. 1500.14(a)(3) and (5) are 
exempt from the labeling requirements of Sec. 1500.14(b)(3)(ii) and (5) 
if the

[[Page 474]]

visicosity of such products is sufficiently high so that they will not 
flow from their opened containers when inverted for 5 minutes at a 
temperature of 80 [deg]F., and are exempt from bearing a flammability 
warning statement if the flammability of such waxes is due solely to the 
presence of solvents that have flashpoints above 80 [deg]F. when tested 
by the method described in Sec. 1500.43.
    (9) Porous-tip ink-marking devices are exempt from the labeling 
requirements of section 2(p)(1) of the act (repeated in Sec. 
1500.3(b)(14)(i)) and from the labeling requirements of Sec. 
1500.14(b)(1), (2), and (3)(ii) and (iii) insofar as such requirements 
would be necessary because the ink contained therein is a toxic 
substance as defined in Sec. 1500.3(c)(2)(i), and/or because the ink 
contains 10 percent or more by weight of toluene (also known as toluol), 
xylene (also known as xylol), or petroleum distillates as defined in 
Sec. 1500.14(a)(3), and/or because the ink contains 10 percent or more 
by weight of ethylene glycol; provided that:
    (i) The porous-tip ink-marking devices are of such construction 
that:
    (A) The ink is held within the device by an absorbent material so 
that no free liquid is within the device; and
    (B) Under any reasonably foreseeable conditions of manipulation and 
use, including reasonably foreseeable abuse by children, the ink will 
emerge only through the porous writing nib of the device; and
    (ii)(A) The device has a capacity of not more than 10 grams of ink 
and the ink, when tested by methods described in Sec. 1500.3(c)(2)(i), 
has an LD-50 single oral dose of not less than 2.5 grams per kilogram of 
body weight of the test animal; or
    (B) The device has a capacity of not more than 12 grams of ink and 
the ink, when tested by methods described in Sec. 1500.3(c)(2)(i), has 
an LD-50 single oral dose of not less than 3.0 grams per kilogram of 
body weight of the test animal.
    (10) Viscous nitrocellulose-base adhesives containing more than 4 
percent methyl alcohol by weight are exempt from the label statement 
``Cannot be be made nonpoisonous'' required by Sec. 1500.14(b)(4) if:
    (i) The total amount of methyl alcohol by weight in the product does 
not exceed 15 percent; and
    (ii) The contents of any container does not exceed 2 fluid ounces.
    (11) Packages containing polishing or cleaning products which 
consist of a carrier of solid particulate or fibrous composition and 
which contain toluene (also known as toluol), xylene (also known as 
xylol), or petroleum distillates in the concentrations described in 
Sec. 1500.14(a) (1) and (2) are exempt from the labeling requirements 
of Sec. 1500.14(b)(3)(ii) if such toluene, xylene, or petroleum 
distillate is fully absorbed by the solid, semisolid, or fibrous carrier 
and cannot be expressed therefrom with any reasonably foreseeable 
conditions of manipulation.
    (12) Containers of dry ink intended to be used as a liquid ink after 
the addition of water are exempt from the labeling requirements of 
section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) and from 
the labeling requirements of Sec. 1500.14(b) (1) and (2) insofar as 
such requirements would be necessary because the dried ink contained 
therein is a toxic substance as defined in Sec. 1500.3(c)(2)(i) and/or 
because the ink contains 10 percent or more of ethylene glycol as 
defined in Sec. 1500.14(a)(2); provided that:
    (i) When tested by the method described in Sec. 1500.3(c)(2)(i), 
the dry ink concentrate does not have an LD-50 (lethal dose, median; 
lethal for 50 percent or more of test group) single oral dose of less 
than 1 gram per kilogram of body weight of the test animal.
    (ii) The dry ink concentrate enclosed in a single container does not 
weigh more than 75 milligrams.
    (iii) The dry ink concentrate does not contain over 15 percent by 
weight of ethylene glycol.
    (13) Containers of liquid and semisolid substances such as viscous-
type paints, varnishes, lacquers, roof coatings, rubber vulcanizing 
preparations, floor covering adhesives, glazing compounds, and other 
viscous products containing toluene (also known as toluol), xylene (also 
known as xylol), or petroleum distillates in concentrations described in 
Sec. 1500.14(a)(3) are exempt from the labeling requirements of

[[Page 475]]

Sec. 1500.14(b)(3)(ii) insofar as that subdivision applies to such 
toluene, xylene, or petroleum distillates, provided that the viscosity 
of the substance or of any liquid that may separate or be present in the 
container is not less than 100 Saybolt universal seconds at 100 [deg]F.
    (14) Customer-owned portable containers that are filled by retail 
vendors with gasoline, kerosene (kerosine), or other petroleum 
distillates are exempt from the provision of section 2(p)(1)(A) of the 
act (which requires that the name and place of business of the 
manufacturer, distributor, packer, or seller appear on the label of such 
containers) provided that all the other label statements required by 
section 2(p)(1) of the act and Sec. 1500.14(b)(3) appear on the labels 
of containers of the substances named in this subparagraph.
    (15) Cellulose sponges are exempt from the labeling requirements of 
section 2(p)(1) of the act and Sec. 1500.14(b)(1) insofar as such 
requirements would be necessary because they contain 10 percent or more 
of diethylene glycol as defined in Sec. 1500.14(a)(1), provided that:
    (i) The cellulose sponge does not contain over 15 percent by weight 
of diethylene glycol; and
    (ii) The diethylene glycol content is completely held by the 
absorbent cellulose material so that no free liquid is within the sponge 
as marketed.
    (16) Containers of substances which include salt (sodium chloride) 
as a component are exempt from the labeling requirements of section 
2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar as such 
requirements would be necessary because the salt contained therein is 
present in a quantity sufficient to render the article ``toxic'' as 
defined in Sec. 1500.3(3)(2)(i), provided that the labels of such 
containers bear a conspicuous statement that the product contains salt.
    (17) The labeling of substances containing 10 percent or more of 
ferrous oxalate is exempt from the requirement of Sec. 1500.129(f) that 
it bear the word ``poison'' which would be required for such 
concentration of a salt of oxalic acid.
    (18) Packages containing articles intended as single-use spot 
removers, and which consist of a cotton pad or other absorbent material 
saturated with a mixture of drycleaning solvents, are exempt from the 
labeling requirements of section 2(p)(1) of the act (repeated in Sec. 
1500.3(b)(14)(i)) insofar as they apply to the ``flammable'' hazard as 
defined in Sec. 1500.3(c)(6)(iv), provided that:
    (i) The article is packaged in a sealed foil envelope;
    (ii) The total amount of solvent in each package does not exceed 4.5 
milliliters; and
    (iii) The article will ignite only when in contact with an open 
flame, and when so ignited, the article burns with a sooty flame.
    (19) Packages containing articles intended as single-use spot 
removers, and which consist of a cotton pad or other absorbent material 
containing methyl alcohol, are exempt from the labeling requirements of 
Sec. 1500.14(b)(4), if:
    (i) The total amount of cleaning solvent in each package does not 
exceed 4.5 milliliters of which not more than 25 percent is methyl 
alcohol; and
    (ii) The liquid is completely held by the absorbent materials so 
that no free liquid is within the packages marketed.
    (20) Cigarette lighters containing petroleum distillate fuel are 
exempt from the labeling requirements of section 2(p)(1) of the act 
(repeated in Sec. 1500.3(b)(14)(i)) and Sec. 1500.14(b)(3) insofar as 
such requirements would be necessary because the petroleum distillate 
contained therein is flammable and because the substance is named in 
Sec. 1500.14(a)(3) as requiring special labeling, provided that:
    (i) Such lighters contain not more than 10 cubic centimeters of fuel 
at the time of sale; and
    (ii) Such fuel is contained in a sealed compartment that cannot be 
opened without the deliberate removal of the flush-set, screw-type 
refill plug of the lighter.
    (21) Containers of dry granular fertilizers and dry granular plant 
foods are exempt from the labeling requirements of section 2(p)(1) of 
the act (repeated in Sec. 1500.3(b)(14)(i)) insofar as such 
requirements would be necessary because the fertilizer or plant food 
contained therein is a toxic substance as defined in Sec. 
1500.3(c)(2)(i), provided that:
    (i) When tested by the method described in Sec. 1500.3(c)(2)(i), 
the product

[[Page 476]]

has a single dose LD-50 of not less than 3.0 grams per kilogram of body 
weight of the test animal;
    (ii) The label of any such exempt dry granular fertilizers discloses 
the identity of each of the hazardous ingredients;
    (iii) The label bears the name and address of the manufacturer, 
packer, distributor, or seller; and
    (iv) The label bears the statement ``Keep out of the reach of 
children'' or its practical equivalent.
    (22) Small plastic capsules containing a paste composed of powdered 
metal solder mixed with a liquid flux are exempt from the requirements 
of section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)), if:
    (i) The capsule holds not more than one-half milliliter of the 
solder mixture;
    (ii) The capsule is sold only as a component of a kit; and
    (iii) Adequate caution statements appear on the carton of the kit 
and on any accompanying labeling which bears directions for use.
    (23) Chemistry sets and other science education sets intended 
primarily for use by juveniles, and replacement containers of chemicals 
for such sets, are exempt from the requirements of section 2(p)(1) of 
the act (repeated in Sec. 1500.3(b)(14)(i)), if:
    (i) The immediate container of each chemical that is hazardous as 
defined in the act and regulations thereunder bears on its main panel 
the name of such chemical, the appropriate signal word for that 
chemical, and the additional statement ``Read back panel before using'' 
(or ``Read side panel before using,'' if appropriate) and bears on the 
back (or side) panel of the immediate container the remainder of the 
appropriate cautionary statement for the specific chemical in the 
container;
    (ii) The experiment manual or other instruction book or booklet 
accompanying such set bears on the front page thereof, as a preface to 
any written matter in it (or on the cover, if any there be), the 
following caution statement within the borders of a rectangle and in the 
type size specified in Sec. 1500.121:
    WARNING--This set contains chemicals that may be harmful if misused. 
Read cautions on individual containers carefully. Not to be used by 
children except under adult supervision

; and
    (iii) The outer carton of such set bears on the main display panel 
within the borders of a rectangle, and in the type size specified in 
Sec. 1500.121, the caution statement specified in paragraph (a)(23)(ii) 
of this section.
    (24) Fire extinguishers containing fire extinguishing agents which 
are stored under pressure or which develop pressure under normal 
conditions of use are exempt from the labeling requirements of section 
2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar as such 
requirements apply to the pressure hazard as defined in Sec. 
1500.3(c)(7)(i), provided that:
    (i) If the container is under pressure both during storage and under 
conditions of use, it shall be designed to withstand a pressure of at 
least 6 times the charging pressure at 70 [deg]F., except that carbon 
dioxide extinguishers shall be constructed and tested in accordance with 
applicable Interstate Commerce Commission specifications; or
    (ii) If the container is under pressure only during conditions of 
use, it shall be designed to withstand a pressure of not less than 5 
times the maximum pressure developed under closed nozzle conditions at 
70 [deg]F. or 1\1/2\ times the maximum pressure developed under closed 
nozzle conditions at 120 [deg]F., whichever is greater.
    (25) Cleaning and spot removing kits intended for use in cleaning 
carpets, furniture, and other household objects; kits intended for use 
in coating, painting, antiquing, and similarly processing furniture, 
furnishings, equipment, sidings, and various other surfaces; and kits 
intended for use in photographic color processing are exempt from the 
requirements of section 2(p)(1) of the act (repeated in Sec. 
1500.3(b)(14)(i)) and from the requirements of Sec. 1500.14, provided 
that:
    (i) The immediate container of each hazardous substance in the kit 
is fully labeled and in conformance with the requirements of the act and 
regulations thereunder; and
    (ii) The carton of the kit bears on the main display panel (or 
panels) within a

[[Page 477]]

borderline, and in the type size specified in Sec. 1500.121, the 
caution statement ``(Insert proper signal word as specified in paragraph 
(a)(25)(iii) of this section). This kit contains the following chemicals 
that may be harmful if misused: (List hazardous chemical components by 
name.) Read cautions on individual containers carefully. Keep out of the 
reach of children.''
    (iii) If either the word ``POISON'' or ``DANGER'' is required on the 
container of any component of the kit, the same word shall be required 
to appear as part of the caution statement on the kit carton. If both 
``POISON'' and ``DANGER'' are required in the labeling of any component 
or components in the kit, the word ``POISON'' shall be used. In all 
other cases the word ``WARNING'' or ``CAUTION'' shall be used.
    (26) Packages containing articles intended as single-use spot 
removers and containing methyl alcohol are exempt from the labeling 
specified in Sec. 1500.14(b)(4), if:
    (i) The total amount of cleaning solvent in each unit does not 
exceed 1 milliliter, of which not more than 40 percent is methyl 
alcohol;
    (ii) The liquid is contained in a sealed glass ampoule enclosed in a 
plastic container with a firmly attached absorbent wick at one end 
through which the liquid from the crushed ampoule must pass, under the 
contemplated conditions of use; and
    (iii) The labeling of each package of the cleaner bears the 
statement ``WARNING--Keep out of the reach of children,'' or its 
practical equivalent, and the name and place of business of the 
manufacturer, packer, distributor, or seller.
    (27) Packaged fireworks assortments intended for retail distribution 
are exempt from section 2(p)(1) of the act (repeated in Sec. 
1500.3(b)(14)(i)), if:
    (i) The package contains only fireworks devices suitable for use by 
the public and designed primarily to produce visible effects by 
combustion, except that small devices designed to produce audible 
effects may also be included if the audible effect is produced by a 
charge of not more than 2 grains of pyrotechnic composition;
    (ii) Each individual article in the assortment is fully labeled and 
in conformance with the requirements of the act and regulations 
thereunder; and
    (iii) The outer package bears on the main display panel (or panels), 
within the borders of a rectangle and in the type size specified in 
Sec. 1500.121, the caution statement ``WARNING--This assortment 
contains items that may be hazardous if misused and should be used only 
under adult supervision. IMPORTANT--Read cautions on individual items 
carefully.'' (See also Sec. 1500.14(b)(7); Sec. 1500.17(a) (3), (8) 
and (9); Sec. 1500.85(a)(2); and part 1507).
    (28) Packages containing felt pads impregnated with ethylene glycol 
are exempt from the labeling requirements of Sec. 1500.14(b)(1), if:
    (i) The total amount of ethylene glycol in each pad does not exceed 
1 gram; and
    (ii) The liquid is held by the felt pad so that no free ethylene 
glycol is within the package.
    (29) Cigarette lighters containing butane and/or isobutane fuel are 
exempt from the labeling requirements of section 2(p)(1) of the act 
(repeated in Sec. 1500.3(b)(14)(i)) insofar as such requirements would 
otherwise be necessary because the fuel therein is extremely flammable 
and under pressure, provided that:
    (i) The lighters contain not more than 12 grams of fuel at the time 
of sale; and
    (ii) The fuel reservoir is designed to withstand a pressure of at 
least 1\1/2\ times the maximum pressure which will be developed in the 
container at 120 [deg]F.
    (30) The outer retail containers of solder kits each consisting of a 
small tube of flux partially surrounded by a winding of wire-type 
cadmium-free silver solder are exempt from the labeling requirements of 
section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)), if:
    (i) The metal solder contains no cadmium and is not otherwise 
hazardous under the provisions of the act;
    (ii) The tube of flux in the kit is fully labeled and in conformance 
with the act and regulations thereunder, and any accompanying literature 
that bears directions for use also bears all

[[Page 478]]

the information required by section 2(p) of the act; and
    (iii) The main panel of the outer container bears in type size 
specified in Sec. 1500.121 the following: (A) The signal word; (B) a 
statement of principal hazard or hazards; (C) the statement ``Keep out 
of the reach of children,'' or its practical equivalent; and (D) 
instructions to read other cautionary instructions on the tube of flux 
within.
    (31) Visual novelty devices consisting of sealed units, each of 
which unit is a steel and glass cell containing perchloroethylene (among 
other things), are exempt from the requirements of Sec. 1500.121(a) 
that would otherwise require a portion of the warning statement to 
appear on the glass face of the device, provided that:
    (i) The device contains not more than 105 milliliters of 
perchloroethylene and contains no other component that contributes 
substantially to the hazard; and
    (ii) The following cautionary statement appears on the device (other 
than on the bottom) in the type size specified in Sec. 1500.121 (c) and 
(d):

           Caution--If Broken, Resultant Vapors May Be Harmful

    Contains perchloroethylene. Do not expose to extreme heat. If broken 
indoors, open windows and doors until all odor of chemical is gone.
    Keep out of the reach of children.

A practical equivalent may be substituted for the statement ``Keep out 
of the reach of children.''
    (32) Hollow plastic toys containing mineral oil are exempt from the 
labeling specified in Sec. 1500.14(b)(3)(ii), if:
    (i) The article contains no other ingredient that would cause it to 
possess the aspiration hazard specified in Sec. 1500.14(b)(3)(ii);
    (ii) The article contains not more than 6 fluid ounces of mineral 
oil;
    (iii) The mineral oil has a viscosity of at least 70 Saybolt 
universal seconds at 100 [deg]F.;
    (iv) The mineral oil meets the specifications in the N.F. for light 
liquid petrolatum; and
    (v) The container bears the statement ``CAUTION--Contains light 
liquid petrolatum N.F. Discard if broken or leak develops.''
    (33) Containers of mineral oil having a capacity of not more than 1 
fluid ounce and intended for use in producing a smoke effect for toy 
trains are exempt from the labeling specified in Sec. 1500.14(b)(3), 
if:
    (i) The mineral oil meets the specifications in the N.F. for light 
liquid petrolatum;
    (ii) The mineral oil has a viscosity of at least 130 Saybolt 
universal seconds at 100 [deg]F.;
    (iii) The article contains no other ingredient that contributes to 
the hazard; and
    (iv) The label declares the presence light liquid petrolatum and the 
name and place of business of the manufacturer, packer, distributor, or 
seller.
    (34) Viscous products containing more than 4 percent by weight of 
methyl alcohol, such as adhesives, asphalt-base roof and tank coatings, 
and similar products, are exempt from bearing the special labeling 
required by Sec. 1500.14(b)(4), if:
    (i) The product contains not more than 15 percent by weight of 
methyl alcohol;
    (ii) The methyl alcohol does not separate from the other ingredients 
upon standing or through any foreseeable use or manipulation;
    (iii) The viscosity of the product is not less than 7,000 
centipoises at 77 [deg]F., unless the product is packaged in a 
pressurized container and is dispensed as a liquid unsuitable for 
drinking; and
    (iv) The labeling bears the statement ``Contains methyl alcohol. Use 
only in well-ventilated area. Keep out of the reach of children.''
    (35) Individual blasting caps are exempt from bearing the statement 
``Keep out of the reach of children,'' or its practical equivalent, if:
    (i) Each cap bears conspicuously in the largest type size 
practicable the statement ``DANGEROUS--BLASTING CAPS--EXPLOSIVE''; and
    (ii) The outer carton and any accompanying printed matter bear 
appropriate, complete cautionary labeling.
    (36) Individual toy rocket propellant devices and separate delay 
train and/or recovery system activation devices intended for use with 
premanufactured model rocket engines are exempt from bearing the full 
labeling required by

[[Page 479]]

section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar 
as such requirements would be necessary because the articles are 
flammable or generate pressure, provided that:
    (i) The devices are designed and constructed in accordance with the 
specifications in Sec. 1500.85(a)(8), (9) or (14);
    (ii) Each individual device or retail package of devices bears the 
following:
    (A) The statement ``WARNING--FLAMMABLE: Read instructions before 
use'';
    (B) The common or usual name of the article;
    (C) A statement of the type of engine and use classification;
    (D) Instructions for safe disposal; and
    (E) Name and place of business of manufacturer or distributor; and
    (iii) Each individual rocket engine or retail package of rocket 
engines distributed to users is accompanied by an instruction sheet 
bearing complete cautionary labeling and instructions for safe use and 
handling of the individual rocket engines.
    (37) Glues with a cyanoacrylate base in packages containing 3 grams 
or less are exempt from the requirement of Sec. 1500.121(d) that 
labeling which is permitted to appear elsewhere than on the main label 
panel must be in type size no smaller than 6 point type, provided that:
    (i) The main panel of the immediate container bears both the proper 
signal word and a statement of the principal hazard or hazards 
associated with this product, as provided by Sec. 1500.121 (a) and (c);
    (ii) The main panel of the immediate container also bears an 
instruction to read carefully additional warnings elsewhere on the label 
and on any outer package, accompanying leaflet, and display card. The 
instruction to read additional warnings must comply with the size, 
placement, conspicuousness, and contrast requirements of Sec. 1500.121; 
and
    (iii) The remainder of the cautionary labeling required by the act 
that is not on the main label panel must appear elsewhere on the label 
in legible type and must appear on any outer package, accompanying 
leaflet, and display card. If there is no outer package, accompanying 
leaflet, or display card, then the remainder of the required cautionary 
labeling must be displayed on a tag or other suitable material that is 
securely affixed to the article so that the labeling will remain 
attached throughout the conditions of merchandising and distribution to 
the ultimate consumer. That labeling which must appear on any outer 
package, accompanying leaflet, tag, or other suitable material must 
comply with the size, placement, contrast, and conspicuousness 
requirements of Sec. 1500.121(d).
    (38) Rigid or semi-rigid writing instruments and ink cartridges 
having a writing point and an ink reservoir are exempt from the labeling 
requirements of section 2(p)(1) of the act (repeated in Sec. 
1500.3(b)(14)(i) of the regulations) and of regulations issued under 
section 3(b) of the act (Sec. 1500.14(b)(1, 2)) insofar as such 
requirements would be necessary because the ink contained therein is a 
``toxic'' substance as defined in Sec. 1500.3(c)(2)(i) and/or because 
the ink contains 10 percent or more by weight ethylene glycol or 
diethylene glycol, if all the following conditions are met:
    (i) The writing instrument or cartridge is of such construction that 
the ink will, under any reasonably foreseeable condition of manipulation 
and use, emerge only from the writing tip.
    (ii) When tested by the method described in Sec. 1500.3(c)(2)(i), 
the ink does not have an LD-50 single oral dose of less than 2.5 grams 
per kilogram of body weight of the test animal.
    (iii) If the ink contains ethylene glycol or diethylene glycol, the 
amount of such substance, either singly or in combination, does not 
exceed 1 gram per writing instrument or cartridge.
    (iv) The amount of ink in the writing instrument or cartridge does 
not exceed 3 grams.

[38 FR 27012, Sept. 27, 1973; 42 FR 33026, June 29, 1977, as amended at 
43 FR 32745, July 28, 1978; 43 FR 47176, Oct. 13, 1978; 44 FR 42678, 
July 20, 1979; 46 FR 11513, Feb. 9, 1981; 48 FR 16, Jan. 3, 1983; 68 FR 
4699, Jan. 30, 2003]