§1500.3 Definitions. §1500.2 Authority. §1500.1 Scope of ... · 4/15/1997 · 1500.85Exemptions from classification as banned hazardous substances. 1500.86Exemptions from classification

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16 CFR Ch. II (1–1–97 Edition)Pt. 1500

SUBCHAPTER C—FEDERAL HAZARDOUS SUBSTANCES ACTREGULATIONS

PART 1500—HAZARDOUS SUB-STANCES AND ARTICLES; ADMIN-ISTRATION AND ENFORCEMENTREGULATIONS

Sec.1500.1 Scope of subchapter.1500.2 Authority.1500.3 Definitions.1500.4 Human experience with hazardous

substances.1500.5 Hazardous mixtures.1500.12 Products declared to be hazardous

substances under section 3(a) of the act.1500.13 Listing of ‘‘strong sensitizer’’ sub-

stances.1500.14 Products requiring special labeling

under section 3(b) of the act.1500.15 Labeling of fire extinguishers.1500.17 Banned hazardous substances.1500.18 Banned toys and other banned arti-

cles intended for use by children.1500.19 Misbranded toys and other articles

intended for use by children.1500.40 Method of testing toxic substances.1500.41 Method of testing primary irritant

substances.1500.42 Test for eye irritants.1500.43 Method of test for flashpoint of vola-

tile flammable materials by Tagliabueopen-cup apparatus.

1500.43a Method of test for flashpoint ofvolatile flammable materials.

1500.44 Method for determining extremelyflammable and flammable solids.

1500.45 Method for determining extremelyflammable and flammable contents ofself-pressurized containers.

1500.46 Method for determining flashpoint ofextremely flammable contents of self-pressurized containers.

1500.47 Method for determining the soundpressure level produced by toy caps.

1500.48 Technical requirements for deter-mining a sharp point in toys and otherarticles intended for use by childrenunder 8 years of age.

1500.49 Technical requirements for deter-mining a sharp metal or glass edge intoys and other articles intended for useby children under 8 years of age.

1500.50 Test methods for simulating use andabuse of toys and other articles intendedfor use by children.

1500.51 Test methods for simulating use andabuse of toys and other articles intendedfor use by children 18 months of age orless.

1500.52 Test methods for simulating use andabuse of toys and other articles intendedfor use by children over 18 but not over 36months of age.

1500.53 Test methods for simulating use andabuse of toys and other articles intendedfor use by children over 36 but not over 96months of age.

1500.81 Exemptions for food, drugs, cosmet-ics, and fuels.

1500.82 Exemption from full labeling andother requirements.

1500.83 Exemptions for small packages,minor hazards, and special cir-cumstances.

1500.85 Exemptions from classification asbanned hazardous substances.

1500.86 Exemptions from classification as abanned toy or other banned article foruse by children.

1500.121 Labeling requirements; prominence,placement, and conspicuousness.

1500.122 Deceptive use of disclaimers.1500.123 Condensation of label information.1500.125 Labeling requirements for accom-

panying literature.1500.126 Substances determined to be ‘‘spe-

cial hazards.’’1500.127 Substances with multiple hazards.1500.128 Label comment.1500.129 Substances named in the Federal

Caustic Poison Act.1500.130 Self-pressurized containers: label-

ing.1500.133 Extremely flammable contact adhe-

sives; labeling.1500.134 Policy on first aid labeling for sa-

line emesis.1500.135 Summary of guidelines for deter-

mining chronic toxicity.1500.210 Responsibility.1500.211 Guaranty.1500.212 Definition of guaranty; suggested

forms.1500.213 Presentation of views under section

7 of the act.1500.214 Examinations and investigations;

samples.

IMPORTS

1500.265 Imports; definitions.1500.266 Notice of sampling.1500.267 Payment for samples.1500.268 Hearing.1500.269 Application for authorization.1500.270 Granting of authorization.1500.271 Bonds.1500.272 Costs chargeable in connection with

relabeling and reconditioning inadmis-sible imports.

AUTHORITY: 15 U.S.C. 1261–1278.

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373

Consumer Product Safety Commission § 1500.3

SOURCE: 38 FR 27012, Sept. 27, 1973, unlessotherwise noted.

§ 1500.1 Scope of subchapter.

Set forth in this subchapter C are theregulations of the Consumer ProductSafety Commission issued pursuant toand for the implementation of the Fed-eral Hazardous Substances Act asamended (see § 1500.3(a)(1)).

§ 1500.2 Authority.

Authority under the Federal Hazard-ous Substances Act is vested in theConsumer Product Safety Commissionby section 30(a) of the Consumer Prod-uct Safety Act (15 U.S.C. 2079(a)).

§ 1500.3 Definitions.

(a) Certain terms used in this part. Asused in this part:

(1) Act means the Federal HazardousSubstances Act (Pub. L. 86–613, 74 Stat.372–81 (15 U.S.C. 1261–74)) as amendedby:

(i) The Child Protection Act of 1966(Pub. L. 89–756, 80 Stat. 1303–05).

(ii) The Child Protection and ToySafety Act of 1969 (Pub. L. 91–113, 83Stat. 187–90).

(iii) The Poison Prevention Packag-ing Act of 1970 (Pub. L. 91–601, 84 Stat.1670–74).

(2) Commission means the ConsumerProduct Safety Commission estab-lished May 14, 1973, pursuant to provi-sions of the Consumer Product SafetyAct (Pub. L. 92–573, 86 Stat. 1207–33 (15U.S.C. 2051–81)).

(b) Statutory definitions. Except forthe definitions given in section 2 (c)and (d) of the act, which are obsolete,the definitions set forth in section 2 ofthe act are applicable to this part andare repeated for convenience as follows(some of these statutory definitions areinterpreted, supplemented, or providedwith alternatives in paragraph (c) ofthis section):

(1) Territory means any territory orpossession of the United States, includ-ing the District of Columbia and theCommonwealth of Puerto Rico but ex-cluding the Canal Zone.

(2) Interstate commerce means (i) com-merce between any State or territoryand any place outside thereof and (ii)commerce within the District of Co-

lumbia or within any territory not or-ganized with a legislative body.

(3) Person includes an individual,partnership, corporation, and associa-tion.

(4)(i) Hazardous substance means:(A) Any substance or mixture of sub-

stances which is toxic, corrosive, an ir-ritant, a strong sensitizer, flammableor combustible, or generates pressurethrough decomposition, heat, or othermeans, if such substance or mixture ofsubstances may cause substantial per-sonal injury or substantial illness dur-ing or as a proximate result of any cus-tomary or reasonably foreseeable han-dling or use, including reasonably fore-seeable ingestion by children.

(B) Any substance which the Com-mission by regulation finds, pursuantto the provisions of section 3(a) of theact, meet the requirements of section2(f)(1)(A) of the act (restated in (A)above).

(C) Any radioactive substance if,with respect to such substance as usedin a particular class of article or aspackaged, the Commission determinesby regulation that the substance is suf-ficiently hazardous to require labelingin accordance with the act in order toprotect the public health.

(D) Any toy or other article intendedfor use by children which the Commis-sion by regulation determines, in ac-cordance with section 3(e) of the act,presents an electrical, mechanical, orthermal hazard.

(ii) Hazardous substance shall notapply to pesticides subject to the Fed-eral Insecticide, Fungicide, andRodenticide Act, to foods, drugs, andcosmetics subject to the Federal Food,Drug, and Cosmetic Act, nor to sub-stances intended for use as fuels whenstored in containers and used in theheating, cooking, or refrigeration sys-tem of a house. ‘‘Hazardous substance’’shall apply, however, to any articlewhich is not itself a pesticide withinthe meaning of the Federal Insecticide,Fungicide, and Rodenticide Act butwhich is a hazardous substance withinthe meaning of section 2(f)(1) of theFederal Hazardous Substances Act (re-stated in paragraph (b)(4)(i) of this sec-tion) by reason of bearing or contain-ing such a pesticide.


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16 CFR Ch. II (1–1–97 Edition)§ 1500.3

(iii) Hazardous substance shall not in-clude any source material, special nu-clear material, or byproduct materialas defined in the Atomic Energy Act of1954, as amended, and regulations is-sued pursuant thereto by the AtomicEnergy Commission.

(5) Toxic shall apply to any substance(other than a radioactive substance)which has the capacity to produce per-sonal injury or illness to man throughingestion, inhalation, or absorptionthrough any body surface.

(6)(i) Highly toxic means any sub-stance which falls within any of thefollowing categories:

(A) Produces death within 14 days inhalf or more than half of a group of 10or more laboratory white rats eachweighing between 200 and 300 grams, ata single dose of 50 milligrams or lessper kilogram of body weight, whenorally administered; or

(B) Produces death within 14 days inhalf or more than half of a group of 10or more laboratory white rats eachweighing between 200 and 300 grams,when inhaled continuously for a periodof 1 hour or less at an atmospheric con-centration of 200 parts per million byvolume or less of gas or vapor or 2 mil-ligrams per liter by volume or less ofmist or dust, provided such concentra-tion is likely to be encountered by manwhen the substance is used in any rea-sonably foreseeable manner; or

(C) Produces death within 14 days inhalf or more than half of a group of 10or more rabbits tested in a dosage of200 milligrams or less per kilogram ofbody weight, when administered bycontinuous contact with the bare skinfor 24 hours or less.

(ii) If the Commission finds thatavailable data on human experiencewith any substance indicate results dif-ferent from those obtained on animalsin the dosages and concentrations spec-ified in paragraph (b)(6)(i) of this sec-tion, the human data shall take prece-dence.

(7) Corrosive means any substancewhich in contact with living tissue willcause destruction of tissue by chemicalaction, but shall not refer to action oninanimate surfaces.

(8) Irritant means any substance notcorrosive within the meaning of sec-tion 2(i) of the act (restated in para-

graph (b)(7) of this section) which onimmediate, prolonged, or repeated con-tact with normal living tissue will in-duce a local inflammatory reaction.

(9) Strong sensitizer means a substancewhich will cause on normal living tis-sue through an allergic orphotodynamic process ahypersensitivity which becomes evi-dent on reapplication of the same sub-stance and which is designated as suchby the Commission. Before designatingany substance as a strong sensitizer,the Commission, upon consideration ofthe frequency of occurrence and sever-ity of the reaction, shall find that thesubstance has a significant potentialfor causing hypersensitivity.

(10) The terms extremely flammable,flammable, and combustible as theyapply to any substances, liquid, solid,or the contents of any self-pressurizedcontainer, are defined by regulationsissued by the Commission and pub-lished at § 1500.3(c)(6).

(11) Radioactive substance means asubstance which emits ionizing radi-ation.

(12) Label means a display of written,printed, or graphic matter upon theimmediate container of any substanceor, in the cases of an article which isunpackaged or is not packaged in animmediate container intended or suit-able for delivery to the ultimateconsumer, a display of such matter di-rectly upon the article involved orupon a tag or other suitable materialaffixed thereto. A requirement made byor under authority of the act that anyword, statement, or other informationappear on the label shall not be consid-ered to be complied with unless suchword, statement, or other informationalso appears (i) on the outside con-tainer or wrapper, if any there be, un-less it is easily legible through the out-side container or wrapper and (ii) on allaccompanying literature where thereare directions for use, written or other-wise.

(13) Immediate container does not in-clude package liners.

(14) Misbranded hazardous substancemeans a hazardous substance (includ-ing a toy, or other article intended foruse by children, which is a hazardoussubstance, or which bears or contains ahazardous substance in such manner as


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to be susceptible of access by a child towhom such toy or other article is en-trusted) intended, or packaged in aform suitable, for use in the householdor by children, if the packaging or la-beling of such substance is in violationof an applicable regulation issued pur-suant to section 3 or 4 of the PoisonPrevention Packaging Act of 1970 or ifsuch substance, except as otherwiseprovided by or pursuant to section 3 ofthe act (Federal Hazardous SubstancesAct), fails to bear a label:

(i) Which states conspicuously:(A) The name and place of business of

the manufacturer, packer, distributor,or seller;

(B) The common or usual name orthe chemical name (if there be no com-mon or usual name) of the hazardoussubstance or of each component whichcontributes substantially to its hazard,unless the Commission by regulationpermits or requires the use of a recog-nized generic name;

(C) The signal word ‘‘DANGER’’ onsubstances which are extremely flam-mable, corrosive, or highly toxic;

(D) The signal word ‘‘WARNING’’ or‘‘CAUTION’’ on all other hazardoussubstances;

(E) An affirmative statement of theprincipal hazard or hazards, such as‘‘Flammable,’’ ‘‘Combustible,’’ ‘‘VaporHarmful,’’ ‘‘Causes Burns,’’ ‘‘AbsorbedThrough Skin,’’ or similar wording de-scriptive of the hazard;

(F) Precautionary measures describ-ing the action to be followed or avoid-ed, except when modified by regulationof the Commission pursuant to section3 of the act;

(G) Instruction, when necessary orappropriate, for first-aid treatment;

(H) The word Poison for any hazard-ous substance which is defined as‘‘highly toxic’’ by section 2(h) of theact (restated in paragraph (b)(6) of thissection);

(I) Instructions for handling and stor-age of packages which require specialcare in handling or storage; and

(J) The statement (1) ‘‘Keep out ofthe reach of children’’ or its practicalequivalent, or, (2) if the article is in-tended for use by children and is not abanned hazardous substance, adequatedirections for the protection of chil-dren from the hazard; and

(ii) On which any statements re-quired under section 2(p)(1) of the act(restated in paragraph (b)(14)(i) of thissection) are located prominently andare in the English language in con-spicuous and legible type in contrastby typography, layout, or color withother printed matter on the label.

Misbranded hazardous substance alsomeans a household substance as de-fined in section 2(2)(D) of the PoisonPrevention Packaging Act of 1970 if itis a substance described in section2(f)(1) of the Federal Hazardous Sub-stances Act (restated in paragraph(b)(4)(i)(A) of this section) and its pack-aging or labeling is in violation of anapplicable regulation issued pursuantto section 3 or 4 of the Poison Preven-tion Packaging Act of 1970.

(15)(i) Banned hazardous substancemeans:

(A) Any toy, or other article intendedfor use by children, which is a hazard-ous substance, or which bears or con-tains a hazardous substance in suchmanner as to be susceptible of accessby a child to whom such toy or otherarticle is entrusted; or

(B) Any hazardous substance in-tended, or packaged in a form suitable,for use in the household, which theCommission by regulation classifies asa ‘‘banned hazardous substance’’ on thebasis of a finding that, notwithstand-ing such cautionary labeling as is ormay be required under the act for thatsubstance, the degree or nature of thehazard involved in the presence or useof such substance in households is suchthat the objective of the protection ofthe public health and safety can beadequately served only by keeping suchsubstance, when so intended orpackaged, out of the channels of inter-state commerce; Provided, That theCommission by regulation (1) shall ex-empt from section 2(q)(1)(A) of the act(restated in paragraph (b)(15)(i)(A) ofthis section) articles, such as chem-istry sets, which by reason of theirfunctional purpose require the inclu-sion of the hazardous substance in-volved, or necessarily present an elec-trical, mechanical, or thermal hazard,and which bear labeling giving ade-quate directions and warnings for safe


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16 CFR Ch. II (1–1–97 Edition)§ 1500.3

use and are intended for use by chil-dren who have attained sufficient ma-turity, and may reasonably be ex-pected, to read and heed such direc-tions and warnings, and (2) shall ex-empt from section 2(q)(1)(A) of the act(restated in paragraph (b)(15)(i)(A) ofthis section), and provide for the label-ing of, common fireworks (includingtoy paper caps, cone fountains, cyl-inder fountains, whistles without re-port, and sparklers) to the extent thatthe Commission determines that sucharticles can be adequately labeled toprotect the purchasers and users there-of.

(ii) Proceedings for the issuance,amendment, or repeal of regulationspursuant to section 2(q)(1)(B) of the act(restated in paragraph (b)(15)(i)(B) ofthis section) shall be governed by theprovisions of section 701 (e), (f), and (g)of the Federal Food, Drug, and Cos-metic Act: Provided, That if the Com-mission finds that the distribution forhousehold use of the hazardous sub-stance involved presents an imminenthazard to the public health, the Com-mission may by order published in theFEDERAL REGISTER give notice of suchfinding, and thereupon such substancewhen intended or offered for householduse, or when so packaged as to be suit-able for such use, shall be deemed to bea ‘‘banned hazardous substance’’ pend-ing the completion of proceedings re-lating to the issuance of such regula-tions.

(16) ‘‘Electrical hazard’’—an articlemay be determined to present an elec-trical hazard if, in normal use or whensubjected to reasonably foreseeabledamage or abuse, its design or manu-facture may cause personal injury orillness by electric shock.

(17) ‘‘Mechanical hazard’’—an articlemay be determined to present a me-chanical hazard if, in normal use orwhen subjected to reasonably foresee-able damage or abuse, its design ormanufacture presents an unreasonablerisk of personal injury or illness:

(i) From fracture, fragmentation, ordisassembly of the article;

(ii) From propulsion of the article (orany part or accessory thereof);

(iii) From points or other protru-sions, surfaces, edges, openings, or clo-sures;

(iv) From moving parts;(v) From lack or insufficiency of con-

trols to reduce or stop motion;(vi) As a result of self-adhering char-

acteristics of the article;(vii) Because the article (or any part

or accessory thereof) may be aspiratedor ingested;

(viii) Because of instability; or(ix) Because of any other aspect of

the article’s design or manufacture.(18) ‘‘Thermal hazard’’—an article

may be determined to present a ther-mal hazard if, in normal use or whensubjected to reasonably foreseeabledamage or abuse, its design or manu-facture presents an unreasonable riskof personal injury or illness because ofheat as from heated parts, substances,or surfaces.

(c) Certain statutory definitions inter-preted, supplemented, or provided with al-ternatives. The following items inter-pret, supplement, or provide alter-natives to definitions set forth in sec-tion 2 of the act (and restated in para-graph (b) of this section):

(1) To provide flexibility as to thenumber of animals tested, the follow-ing is an alternative to the definitionof ‘‘highly toxic’’ in section 2(h) of theact (and paragraph (b)(6) of this sec-tion); Highly toxic means:

(i) A substance determined by theCommission to be highly toxic on thebasis of human experience; and/or

(ii) A substance that produces deathwithin 14 days in half or more than halfof a group of:

(A) White rats (each weighing be-tween 200 and 300 grams) when a singledose of 50 milligrams or less per kilo-gram of body weight is administeredorally;

(B) White rats (each weighing be-tween 200 and 300 grams) when a con-centration of 200 parts per million byvolume or less of gas or vapor, or 2 mil-ligrams per liter by volume or less ofmist or dust, is inhaled continuouslyfor 1 hour or less, if such concentrationis likely to be encountered by manwhen the substance is used in any rea-sonably foreseeable manner; and/or

(C) Rabbits (each weighing between2.3 and 3.0 kilograms) when a dosage of200 milligrams or less per kilogram ofbody weight is administered by contin-uous contact with the bare skin for 24


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hours or less by the method describedin § 1500.40.

The number of animals tested shall besufficient to give a statistically signifi-cant result and shall be in conformitywith good pharmacological practices.

(2) To give specificity to the defini-tion of ‘‘toxic’’ in section 2(g) of theact (and restated in paragraph (b)(5) ofthis section), the following supple-ments that definition. The followingcategories are not intended to be inclu-sive.

(i) Acute toxicity. Toxic means anysubstance that produces death within14 days in half or more than half of agroup of:

(A) White rats (each weighing be-tween 200 and 300 grams) when a singledose of from 50 milligrams to 5 gramsper kilogram of body weight is admin-istered orally. Substances falling in thetoxicity range between 500 milligramsand 5 grams per kilogram of bodyweight will be considered for exemp-tion from some or all of the labelingrequirements of the act, under § 1500.82,upon a showing that such labeling isnot needed because of the physicalform of the substances (solid, a thickplastic, emulsion, etc.), the size or clo-sure of the container, human experi-ence with the article, or any other rel-evant factors;

(B) White rats (each weighing be-tween 200 and 300 grams) when an at-mospheric concentration of more than200 parts per million but not more than20,000 parts per million by volume ofgas or vapor, or more than 2 but notmore than 200 milligrams per liter byvolume of mist or dust, is inhaled con-tinuously for 1 hour or less, if suchconcentration is likely to be encoun-tered by man when the substance isused in any reasonably foreseeablemanner: and/or

(C) Rabbits (each weighing between2.3 and 3.0 kilograms) when a dosage ofmore than 200 milligrams but not morethan 2 grams per kilogram of bodyweight is administered by continuouscontact with the bare skin for 24 hoursby the method described in § 1500.40.

The number of animals tested shall besufficient to give a statistically signifi-cant result and shall be in conformitywith good pharmacological practices.

‘‘Toxic’’ also applies to any substancethat is ‘‘toxic’’ (but not ‘‘highly toxic’’)on the basis of human experience.

(ii) Chronic toxicity. A substance istoxic because it presents a chronic haz-ard if it falls into one of the followingcategories. (For additional informationsee the chronic toxicity guidelines at16 CFR 1500.135.)

(A) For Carcinogens. A substance istoxic if it is or contains a known orprobable human carcinogen.

(B) For Neurotoxicological Toxicants. Asubstance is toxic if it is or contains aknown or probable human neurotoxin.

(C) For Developmental or ReproductiveToxicants. A substance is toxic if it isor contains a known or probablehuman developmental or reproductivetoxicant.

(3) The definition of corrosive in sec-tion 2(i) of the act (restated in para-graph (b)(7) of this section) is inter-preted to also mean the following: Cor-rosive means a substance that causesvisible destruction or irreversible al-terations in the tissue at the site ofcontact. A test for a corrosive sub-stance is whether, by human experi-ence, such tissue destruction occurs atthe site of application. A substancewould be considered corrosive to theskin if, when tested on the intact skinof the albino rabbit by the techniquedescribed in § 1500.41, the structure ofthe tissue at the site of contact is de-stroyed or changed irreversibly in 24hours or less. Other appropriate testsshould be applied when contact of thesubstance with other than skin tissueis being considered.

(4) The definition of irritant in section2(j) of the act (restated in paragraph(b)(8) of this section) is supplementedby the following: Irritant includes ‘‘pri-mary irritant to the skin’’ as well assubstances irritant to the eye or tomucous membranes. Primary irritantmeans a substance that is not corrosiveand that human experience data indi-cate is a primary irritant and/or meansa substance that results in an empiri-cal score of five or more when tested bythe method described in § 1500.41. Eye ir-ritant means a substance that humanexperience data indicate is an irritantto the eye and/or means a substance forwhich a positive test is obtained when


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16 CFR Ch. II (1–1–97 Edition)§ 1500.3

tested by the method described in§ 1500.42.

(5) The definition of strong sensitizerin section 2(k) of the Federal Hazard-ous Substances Act (restated in 16 CFR1500.3(b)(9)) is supplemented by the fol-lowing definitions:

(i) Sensitizer. A sensitizer is a sub-stance that will induce animmunologically-mediated (allergic)response, including allergicphotosensitivity. This allergic reactionwill become evident upon reexposure tothe same substance. Occasionally, asensitizer will induce and elicit an al-lergic response on first exposure by vir-tue of active sensitization.

(ii) Strong. In determining that a sub-stance is a ‘‘strong’’ sensitizer, theCommission shall consider the avail-able data for a number of factors.These factors should include any or allof the following (if available): Quan-titative or qualitative risk assessment,frequency of occurrence and range ofseverity of reactions in healthy or sus-ceptible populations, the result of ex-perimental assays in animals or hu-mans (considering dose-response fac-tors), with human data taking prece-dence over animal data, other data onpotency or bioavailability of sensitiz-ers, data on reactions to a cross-react-ing substance or to a chemical thatmetabolizes or degrades to form thesame or a cross-reacting substance, thethreshold of human sensitivity, epide-miological studies, case histories, oc-cupational studies, and other appro-priate in vivo and in vitro test studies.

(iii) Severity of reaction. The minimalseverity of reaction for the purpose ofdesignating a material as a ‘‘strongsensitizer’’ is a clinically important al-lergic reaction. For example, strongsensitizers may produce substantial ill-ness, including any or all of the follow-ing: physical discomfort, distress, hard-ship, and functional or structural im-pairment. These may, but not nec-essarily, require medical treatment orproduce loss of functional activities.

(iv) Significant potential for causinghypersensitivity. ‘‘Significant potentialfor causing hypersensitivity’’ is a rel-ative determination that must be madeseparately for each substance. It maybe based upon the chemical or func-tional properties of the substance, doc-

umented medical evidence of allergicreactions obtained from epidemiolog-ical surveys or individual case reports,controlled in vitro or in vivo experi-mental assays, or susceptibility pro-files in normal or allergic subjects.

(v) Normal living tissue. The allergichypersensitivity reaction occurs innormal living tissues, including theskin and other organ systems, such asthe respiratory or gastrointestinaltract, either singularly or in combina-tion, following sensitization by con-tact, ingestion, or inhalation.

(6) The Consumer Product SafetyCommission, by the regulations pub-lished in this section, defines the termsextremely flammable, flammable, and com-bustible, appearing in section 2(1) of theFederal Hazardous Substances Act, asfollows:

(i) The term extremely flammable shallapply to any substance which has aflashpoint at or below 20 °F (¥6.7 °C) asdetermined by the test method de-scribed at § 1500.43a, except that, anymixture having one component or morewith a flashpoint higher than 20 °F(¥6.7 °C) which comprises at least 99percent of the total volume of the mix-ture is not considered to be an ex-tremely flammable substance.

(ii) The term flammable shall apply toany substance having a flashpointabove 20 °F (¥6.7 °C) and below 100 °F(37.8 °C), as determined by the methoddescribed at § 1500.43a, except that:

(A) Any mixture having one compo-nent or more with a flashpoint at orabove 100 °F (37.8 °C) which comprisesat least 99 percent of the total volumeof the mixture is not considered to bea flammable substance; and

(B) Any mixture containing 24 per-cent or less of water miscible alcohols,by volume, in aqueous solution is notconsidered to be flammable if the mix-ture does not present a significantflammability hazard when used by con-sumers.

(iii) The term combustible shall applyto any substance having a flashpoint ator above 100 °F (37.8 °C) to and includ-ing 150 °F (65.6 °C) as determined by thetest method described at § 1500.43a, ex-cept that:

(A) Any mixture having one compo-nent or more with a flashpoint higherthan 150 °F (65.6 °C) which comprises at


379


least 99 percent of the total volume ofthe mixture is not considered to be acombustible hazardous substance; and

(B) Any mixture containing 24 per-cent or less of water miscible alcohols,by volume, in aqueous solution is notconsidered to be combustible if themixture does not present a significantflammability hazard when used by con-sumers.

(iv) To determine flashpoint tem-peratures for purposes of enforcing andadministering requirements of the Fed-eral Hazardous Substances Act applica-ble to ‘‘extremely flammable,’’ ‘‘flam-mable,’’ and ‘‘combustible’’ hazardoussubstances, the Commission will followthe procedures set forth in § 1500.43a.However, the Commission will allowmanufacturers and labelers of sub-stances and products subject to thoserequirements to rely on properly con-ducted tests using the Tagliabue open-cup method which was in effect prior tothe issuance of § 1500.43a (as publishedat 38 FR 27012, September 27, 1973, andset forth below), and the defintions ofthe terms ‘‘extremely flammable,’’‘‘flammable,’’ and ‘‘combustible’’ inthis section before its amendment (aspublished at 38 FR 27012, September 27,1983, and amended 38 FR 30105, Novem-ber 1, 1973, set forth in the note follow-ing this section) if all of the followingconditions are met:

(A) The substance or product wassubject to and complied with the re-quirements of the Federal HazardousSubstances Act for ‘‘extremely flam-mable,’’ ‘‘flammable,’’ or ‘‘combus-tible’’ hazardous substances before theeffective date of § 1500.43a; and

(B) No change has been made to theformulation or labeling of such sub-stance or product after the effectivedate of § 1500.43a, prescribing a closed-cup test apparatus and procedure.

(v) Extremely flammable solid means asolid substance that ignites and burnsat an ambient temperature of 80 °F orless when subjected to friction, percus-sion, or electrical spark.

(vi) Flammable solid means a solidsubstance that, when tested by themethod described in § 1500.44, ignitesand burns with a self-sustained flameat a rate greater than one-tenth of aninch per second along its major axis.

(vii) Extremely flammable contents ofself-pressurized container means con-tents of a self-pressurized containerthat, when tested by the method de-scribed in § 1500.45, a flashback (a flameextending back to the dispenser) is ob-tained at any degree of valve openingand the flashpoint, when tested by themethod described in § 1500.43a is lessthan 20 °F (¥6.7 °C).

(viii) Flammable contents of self-pres-surized container means contents of aself-pressurized container that, whentested by the method described in§ 1500.45, a flame projection exceeding18 inches is obtained at full valve open-ing, or flashback (a flame extendingback to the dispenser) is obtained atany degree of valve opening.

(7) The definition of hazardous sub-stance in section 2(f)(1)(A) of the act(restated in paragraph (b)(4)(i)(A) ofthis section) is supplemented by thefollowing definitions or interpretationsor terms used therein:

(i) A substance or mixture of sub-stances that ‘‘generates pressurethrough decomposition, heat, or othermeans’’ is a hazardous substance:

(A) If it explodes when subjected toan electrical spark, percussion, or theflame of a burning paraffin candle for 5seconds or less.

(B) If it expels the closure of its con-tainer, or bursts its container, whenheld at or below 130 °F. for 2 days orless.

(C) If it erupts from its opened con-tainer at a temperature of 130 °F. orless after having been held in theclosed container at 130 °F. for 2 days.

(D) If it comprises the contents of aself-pressurized container.

(ii) Substantial personal injury or ill-ness means any injury or illness of asignificant nature. It need not be se-vere or serious. What is excluded bythe word ‘‘substantial’’ is a wholly in-significant or negligible injury or ill-ness.

(iii) Proximate result means a resultthat follows in the course of eventswithout an unforeseeable, intervening,independent cause.

(iv) Reasonably foreseeable handling oruse includes the reasonably foreseeableaccidental handling or use, not only bythe purchaser or intended user of the


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product, but by all others in a house-hold, especially children.

(8) The definition of ‘‘radioactivesubstance’’ in section 2(m) of the act(restated in paragraph (b)(11) of thissection) is supplemented by the follow-ing: Radioactive substance means a sub-stance which, because of nuclear insta-bility, emits electromagnetic and/orparticulate radiation capable of pro-ducing ions in its passage through mat-ter. Source materials, special nuclearmaterial, and byproduct materials de-scribed in section 2(f)(3) of the act areexempt.

(9) In the definition of ‘‘label’’ in sec-tion 2(n) of the act (restated in para-graph (b)(12) of this section), a provi-sion stipulates that words, statements,or other information required to be onthe label must also appear on all ac-companying literature where there aredirections for use, written or other-wise. To make this provision more spe-cific, ‘‘accompanying literature’’ is in-terpreted to mean any placard, pam-phlet, booklet, book, sign, or otherwritten, printed, or graphic matter orvisual device that provides directionsfor use, written or otherwise, and thatis used in connection with the display,sale, demonstration, or merchandisingof a hazardous substance intended foror packaged in a form suitable for usein the household or by children.

(10) The definition of ‘‘misbrandedhazardous substance’’ in section 2(p) ofthis act (restated in paragraph (b)(14)of this section) is supplemented by thefollowing definitions or interpretationsof terms used therein:

(i) Hazardous substances intended, orpackaged in a form suitable, for use in thehousehold means any hazardous sub-stance, whether or not packaged, thatunder any customary or reasonablyforeseeable condition of purchase, stor-age, or use may be brought into oraround a house, apartment, or otherplace where people dwell, or in oraround any related building or shed in-cluding, but not limited to, a garage,carport, barn, or storage shed. Theterm includes articles, such as polishesor cleaners, designed primarily for pro-fessional use but which are available inretail stores, such as hobby shops, fornonprofessional use. Also included areitems, such as antifreeze and radiator

cleaners, that although principally forcar use may be stored in or arounddwelling places. The term does not in-clude industrial supplies that might betaken into a home by a serviceman. Anarticle labeled as, and marketed solelyfor, industrial use does not become sub-ject to this act because of the possibil-ity that an industrial worker may takea supply for his own use. Size of unit orcontainer is not the only index ofwhether the article is suitable for usein or around the household; the testshall be whether under any reasonablyforeseeable condition of purchase, stor-age, or use the article may be found inor around a dwelling.

(ii) Conspicuously in section 2(p)(1) ofthe act and prominently and conspicuousin section 2(p)(2) of the act mean that,under customary conditions of pur-chase, storage, and use, the requiredinformation shall be visible, notice-able, and in clear and legible English.Some factors affecting a warning’sprominence and conspicuousness are:Location, size of type, and contrast ofprinting against background. Alsobearing on the effectiveness of a warn-ing might be the effect of the packagecontents if spilled on the label.

NOTE: The definitions of extremely flam-mable, flammable, and combustible hazardoussubstances set forth above in paragraphs(b)(10) and (c)(6) are effective August 10, 1987.The definitions remaining in effect until Au-gust 10, 1987, as published at 38 FR 27012,Sept. 27, 1973, and amended at 38 FR 30105,Nov. 1, 1973, are set forth below. Manufactur-ers and labelers of products subject to theFederal Hazardous Substances Act may con-tinue to use these definitions for labeling ofthose products under the conditions set forthin § 1500.3(c)(6)(iv), as amended.

(b)(10) Extremely flammable shall applyto any substance which has aflashpoint at or below 20 °F. as deter-mined by the Tagliabue Open Cup Test-er; flammable shall apply to any sub-stance which has a flashpoint of above20 °F., to and including 80 °F., as deter-mined by the Tagliabue Open Cup Test-er; and combustible shall apply to anysubstance which has a flashpoint above80 °F. to and including 150 °F., as deter-mined by the Tagliabue Open Cup Test-er; except that the flammability orcombustibility of solids and of the con-tents of self-pressurized containersshall be determined by methods found


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by the Commission to be generally ap-plicable to such materials or contain-ers, respectively, and established byregulations issued by the Commission,which regulations shall also define theterms flammable, combustible, and ex-tremely flammable in accord with suchmethods.

* * * * *

(c)(6)(i) Extremely flammable meansany substance that has a flashpoint ator below 20 °F. as determined by themethod described in § 1500.43.

(ii) Flammable means any substancethat has a flashpoint of above 20 °F., toand including 80 °F., as determined bythe method described in § 1500.43.

[38 FR 27012, Sept. 27, 1973, as amended at 38FR 30105, Nov. 1, 1973; 49 FR 22465, May 30,1984; 51 FR 28536, Aug. 8, 1986; 51 FR 29096,Aug. 14, 1986; 51 FR 30209, Aug. 25, 1986; 57 FR46669, Oct. 9, 1992]

§ 1500.4 Human experience with haz-ardous substances.

(a) Reliable data on human experi-ence with any substance should betaken into account in determiningwhether an article is a ‘‘hazardous sub-stance’’ within the meaning of the act.When such data give reliable resultsdifferent from results with animaldata, the human experience takes prec-edence.

(b) Experience may show that an ar-ticle is more or less toxic, irritant, orcorrosive to man than to test animals.It may show other factors that are im-portant in determining the degree ofhazard to humans represented by thesubstance. For example, experienceshows that radiator antifreeze is likelyto be stored in the household or garageand likely to be ingested in significantquantities by some persons. It alsoshows that a particular substance inliquid form is more likely to be in-gested than the same substance in apaste or a solid and that an aerosol ismore likely to get into the eyes andthe nasal passages than a liquid.

§ 1500.5 Hazardous mixtures.For a mixture of substances, the de-

termination of whether the mixture isa ‘‘hazardous substance’’ as defined bysection 2(f) of the act (repeated in§ 1500.3(b)(4)) should be based on the

physical, chemical, and pharma-cological characteristics of the mix-ture. A mixture of substances maytherefore be less hazardous or morehazardous than its components becauseof synergistic or antagonistic reac-tions. It may not be possible to reach afully satisfactory decision concerningthe toxic, irritant, corrosive, flam-mable, sensitizing, or pressure-generat-ing properties of a substance from whatis known about its components or in-gredients. The mixture itself should betested.

§ 1500.12 Products declared to be haz-ardous substances under section3(a) of the act.

(a) The Commission finds that thefollowing articles are hazardous sub-stances within the meaning of the actbecause they are capable of causingsubstantial personal injury or substan-tial illness during or as a proximate re-sult of any customary or reasonablyforeseeable handling or use:

(1) Charcoal briquettes and otherforms of charcoal in containers for re-tail sale and intended for cooking orheating.

§ 1500.13 Listing of ‘‘strong sensitizer’’substances.

On the basis of frequency of occur-rence and severity of reaction informa-tion, the Commission finds that thefollowing substances have a significantpotential for causing hypersensitivityand therefore meet the definition for‘‘strong sensitizer’’ in section 2(k) ofthe act (repeated in § 1500.3(b)(9)):

(a) Paraphenylenediamine and prod-ucts containing it.

(b) Powdered orris root and productscontaining it.

(c) Epoxy resins systems containingin any concentration ethylenediamine,diethylenetriamine, and diglycidylethers of molecular weight of less than200.

(d) Formaldehyde and products con-taining 1 percent or more of formalde-hyde.

(e) Oil of bergamot and products con-taining 2 percent or more of oil of ber-gamot.


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§ 1500.14 Products requiring speciallabeling under section 3(b) of theact.

(a) Human experience, as reported inthe scientific literature and to the Poi-son Control Centers and the NationalClearing House for Poison Control Cen-ters, and opinions of informed medicalexperts establish that the followingsubstances are hazardous:

(1) Diethylene glycol and mixturescontaining 10 percent or more byweight of diethylene glycol.

(2) Ethylene glycol and mixtures con-taining 10 percent or more by weight ofethylene glycol.

(3) Products containing 5 percent ormore by weight of benzene (also knownas benzol) and products containing 10percent or more by weight of toluene(also known as toluol), xylene (alsoknown as xylol), or petroleum dis-tillates such as kerosine, mineral sealoil, naphtha, gasoline, mineral spirits,stoddard solvent, and related petro-leum distillates.

(4) Methyl alcohol (methanol) andmixtures containing 4 percent or moreby weight of methyl alcohol (meth-anol).

(5) Turpentine (including gum tur-pentine, gum spirits of turpentine,steam-distilled wood turpentine, sul-fate wood turpentine, and destructivelydistilled wood turpentine) and mix-tures containing 10 percent or more byweight of such turpentine.

(b) The Commission finds that thefollowing substances present specialhazards and that, for these substances,the labeling required by section 2(p)(1)of the act is not adequate for the pro-tection of the public health. Under sec-tion 3(b) of the act, the following spe-cific label statements are deemed nec-essary to supplement the labeling re-quired by section 2(p)(1) of the act:

(1) Diethylene glycol. Becausediethylene glycol and mixtures con-taining 10 percent or more by weight ofdiethylene glycol are commonly mar-keted, stored, and used in a manner in-creasing the possibility of accidentalingestion, such products shall be la-beled with the signal word ‘‘warning’’and the statement ‘‘Harmful if swal-lowed.’’

(2) Ethylene glycol. Because ethyleneglycol and mixtures containing 10 per-

cent or more by weight of ethylene gly-col are commonly marketed, stored,and used in a manner increasing thepossibility of accidental ingestion,such products shall be labeled with thesignal word ‘‘warning’’ and the state-ment ‘‘Harmful or fatal if swallowed.’’

(3) Benzene, toluene, xylene, petroleumdistillates. (i) Because inhalation of thevapors of products containing 5 percentor more by weight of benzene maycause blood dyscrasias, such productsshall be labeled with the signal word‘‘danger,’’ the statement of hazard‘‘Vapor harmful,’’ the word ‘‘poison,’’and the skull and crossbones symbol. Ifthe product contains 10 percent ormore by weight of benzene, it shallbear the additional statement of haz-ard ‘‘Harmful or fatal if swallowed’’and the additional statement ‘‘Callphysician immediately.’’

(ii) Because products containing 10percent or more by weight of toluene,xylene, or any of the other substanceslisted in paragraph (a)(3) of this sectionmay be aspirated into the lungs, withresulting chemical pneumonitis, pneu-monia, and pulmonary edema, suchproducts shall be labeled with the sig-nal word ‘‘danger,’’ the statement orhazard ‘‘Harmful or fatal if swal-lowed,’’ and the statement ‘‘Call physi-cian immediately.’’

(iii) Because inhalation of the vaporof products containing 10 percent ormore by weight of toluene or xylenemay cause systemic injury, such prod-ucts shall bear the statement of hazard‘‘Vapor harmful’’ in addition to thestatements prescribed in paragraph(b)(3)(ii) of this section.

(4) Methyl alcohol (methanol). Becausedeath and blindness can result from theingestion of methyl alcohol, the labelfor this substance and for mixturescontaining 4 percent or more by weightof this substance shall include the sig-nal word ‘‘danger,’’ the additional word‘‘poison,’’ and the skull and crossbonessymbol. The statement of hazard shallinclude ‘‘Vapor harmful’’ and ‘‘May befatal or cause blindness if swallowed.’’The label shall also bear the statement‘‘Cannot be made nonpoisonous.’’

(5) Turpentine. Because turpentine(including gum turpentine, gum spiritsof turpentine, steam-distilled wood tur-pentine, sulfate wood turpentine, and


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destructively distilled wood turpen-tine) and products containing 10 per-cent or more by weight of such turpen-tine, in addition to oral toxicity result-ing in systemic poisoning, may be aspi-rated into the lungs with resultingchemical pneumonitis, pneumonia, andpulmonary edema, such products shallbe labeled with the signal word ‘‘dan-ger’’ and the statement of hazard‘‘Harmful or fatal if swallowed.’’

(6) Charcoal. Charcoal briquettes andother forms of charcoal in containersfor retail sale and intended for cookingor heating.

(i)(A) Because inhalation of the car-bon monoxide produced by burningcharcoal indoors or in confined areasmay cause serious injury or death, con-tainers of such products packaged be-fore November 3, 1997, shall bear thefollowing borderlined statement:

WARNING: Do Not Use for Indoor Heat-ing or Cooking Unless Ventilation Is Pro-vided for Exhausting Fumes to Outside.Toxic Fumes May Accumulate and CauseDeath.

(B) For bags of charcoal packaged be-fore November 3, 1997, the statementspecified in paragraph (b)(6)(i) of thissection shall appear within a heavyborderline in a color sharply contrast-ing to that of the background, on bothfront and back panels in the upper 25percent of the panels of the bag at least2 inches below the seam, and at least 1inch above any reading material or de-sign elements in type size as follows:The signal word ‘‘WARNING’’ shall ap-pear in capital letters at least three-eighths inch in height; the remainingtext of the warning statement shall beprinted in letters at least three-six-teenths inch in height.

(ii)(A) Because inhalation of the car-bon monoxide produced by burningcharcoal indoors or in confined areascan cause serious injury or death, con-tainers of such products packaged onor after November 3, 1997, shall bearthe following borderlined label.

(B) Except as provided in paragraph(b)(6)(ii)(C) of this section, the follow-ing requirements apply to bags of char-coal subject to paragraph (b)(6)(ii)(A)of this section. The label specified inparagraph (b)(6)(ii)(A) of this sectionshall appear within a heavy borderline,in a color sharply contrasting to thatof the background, on both the frontand back panels in the upper 25 percentof the panels of the bag, and with theouter edge of the borderline at least

2.54 cm (1 inch) below the seam and atleast 2.54 cm (1 inch) above any otherreading material or design elements.The signal word ‘‘WARNING’’ shall bein bold capital letters in at least 7.14mm (9⁄32 inch) type. The remaining textof the warning statement shall be in atleast 4.763 mm (3⁄16 inch) type. Thephrase ‘‘CARBON MONOXIDE HAZ-ARD’’ shall be in bold. This phrase andthe word ‘‘NEVER’’ shall be in all cap-ital letters. The lettering shall have a


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strokewidth-to-height ratio of 1:6 to1:8. The label shall be at least 50.8 mm(2 inches) high and 147.5 mm (513⁄16

inches) wide. The label’s lettering,spacing between the bottom of the let-ters of one line and the top of the let-ter of the next line, and pictogramshall have the size relation to eachother and to the remainder of the labelshown in paragraph (b)(6)(ii)(A) of thissection.

(C) For bags of charcoal subject toparagraph (b)(6)(ii)(A) of this sectionthat are 6 inches or less wide, the mini-mum label height may be reduced to 38mm (1.5 inches) and the minimumwidth may be reduced to 139.7 mm (5.5inches). The signal word ‘‘WARNING’’shall be in capital letters in at least6.32 mm (0.249 inch) type. The remain-ing text of the warning shall be in atleast 4.23 mm (0.166 inch) type. Allother requirements of paragraphs6(b)(ii) (A) and (B) of this section shallapply to these bags.

(7) Fireworks devices. Because of thespecial hazards presented by fireworksdevices if not used in a certain manner,the following listed fireworks devicesshall be labeled as indicated:

(i) Fountains.

WARNING (OR CAUTION)

FLAMMABLE (or EMITS SHOWERS OFSPARKS, if more descriptive).

Use only under [close] adult supervision.(Use of the word close is optional.)

For outdoor use only.Place on level surface.Light fuse and get away.

(ii) California candles.

WARNING (OR CAUTION) EMITS SHOWERS OFSPARKS


For outdoor use only.Hold in hand at bottom of tube.Point away from body so that neither end

points toward body.

(iii) Spike and handle cylindrical foun-tains.

(A) Spike fountains.



For outdoor use only.

Stick firmly in ground in an upright posi-tion.

Do not hold in hand.Light fuse and get away.

(B) Handle fountains.



For outdoor use only.Hold in hand—point away from body.Light fuse.

(iv) Roman Candles.

WARNING (OR CAUTION) SHOOTS FLAMINGBALLS


For outdoor use only.Stick butt end in ground.Do not hold in hand.Light fuse and get away.

(v) Rockets with sticks.

WARNING (OR CAUTION) FLAMMABLE


For outdoor use only.Place in wooden trough or iron pipe at 75°

angle, pointing away from people or flam-mable material.

Do not hold in hand.Light fuse and get away.

(vi) Wheels.

WARNING (OR CAUTION) FLAMMABLE (OR EMITSSHOWERS OF SPARKS, IF MORE DESCRIPTIVE)


For outdoor use only.Attach securely by means of a nail through

the hole (or place on hard flat surface, forground spinners).

Light fuse and get away.

(vii) Illuminating torches.



For outdoor use only.Hold in hand—point away from body, cloth-

ing, or other flammable material (or placeupright on level ground. Do not hold inhand, if more descriptive).

Light fuse (or light fuse and get away, ifmore descriptive).

(viii) Sparklers.

On the front and back panels:


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On the side, front, back, top, or bottompanel.

CAUTION


For outdoor use only.Do not touch glowing wire (or do not touch

hot plastic, wood, etc., if more descriptive).Hold in hand with arm extended away from

body.Keep burning end or sparks away from wear-

ing apparel or other flammable material.

(ix) Mines and shells.

WARNING (OR CAUTION) EMITS SHOWERS OFSPARKS (OR SHOOTS FLAMING BALLS, IFMORE DESCRIPTIVE)


For outdoor use only.Place on hard smooth surface (or place up-

right on level ground, if more descriptive).Do not hold in hand.Light fuse and get away.

(x) Whistles without report.


SHOOTS WHISTLE IN AIR (if applicable)Use only under [close] adult supervision.

(Use of the word close is optional.)For outdoor use only.Do not hold in hand.Light fuse and get away.

(xi) Toy smoke devices and flitter de-vices.



For outdoor use only.Do not hold in hand.Light fuse and get away.

(xii) Helicopter-type rockets.



For outdoor use only.Place on hard, open surface.Light fuse and get away.

(xiii) Party poppers.



Do not point either end toward face or otherperson.

Hold in hand—jerk string.

(xiv) Missile-type rockets.

WARNING (OR CAUTION) FLAMMABLE (OR EMITS

SHOWERS OF SPARKS, IF MORE DESCRIPTIVE)


For outdoor use only.Place on hard, open surface.Light fuse and get away.

(xv) Labeling—General. Any fireworksdevice not required to have a specificlabel as indicated above shall carry awarning label indicating to the userwhere and how the item is to be usedand necessary safety precautions to beobserved. All labels required under thissection shall comply with the require-ments of § 1500.121 of these regulations.(See also § 1500.17(a) (3), (8) and (9);§ 1500.83(a)(27); § 1500.85(a)(2); and part1507).

(8) Art materials.

NOTE: The Labeling of Hazardous Art Ma-terials Act (‘‘LHAMA’’), 15 U.S.C. 1277 (Pub.L. 100–695, enacted November 18, 1988) pro-vides that, as of November 18, 1990, ‘‘the re-quirements for the labeling of art materialsset forth in the version of the standard of theAmerican Society for Testing and Materials[‘‘ASTM’’] designated D–4236 that is in effecton [November 18, 1988] * * * shall be deemedto be a regulation issued by the Commissionunder section 3(b)’’ of the Federal HazardousSubstances Act, 15 U.S.C. 1262(b). For theconvenience of interested persons, the Com-mission is including the requirements ofASTM D–4236 in paragraph (b)(8)(i) of thissection, along with other requirements (stat-ed in paragraph (b)(8)(ii) of this section)made applicable to art materials by theLHAMA. The substance of the requirementsspecified in LHAMA became effective on No-vember 18, 1990, as mandated by Congress.

(i) ASTM D–4236—(A) Scope.—(1) Thissection describes a procedure for devel-oping precautionary labels for art ma-terials and provides hazard and pre-cautionary statements based uponknowledge that exists in the scientificand medical communities. This sectionconcerns those chronic health hazardsknown to be associated with a productor product component(s), when thecomponent(s) is present in a physicalform, volume, or concentration that inthe opinion of a toxicologist (see para-graph (b)(8)(i)(B)(11) of this section) hasthe potential to produce a chronic ad-verse health effect(s).


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(2) This section applies exclusively toart materials packaged in sizes in-tended for individual users of any ageor those participating in a small group.

(3) Labeling determinations shallconsider reasonably foreseeable use ormisuse.

(4) Manufacturers or repackagersmay wish to have compliance certifiedby a certifying organization. Guide-lines for a certifying organization aregiven in paragraph (b)(8)(i)(H) of thissection.

(B) Descriptions of Terms Specific toThis Standard. (1) Art material or artmaterial product—any raw or proc-essed material, or manufactured prod-uct, marketed or represented by theproducer or repackager as intended forand suitable for users as defined herein.

(2) Users—artists or crafts people ofany age who create, or recreate in alimited number, largely by hand, workswhich may or may not have a practicaluse, but in which aesthetic consider-ations are paramount.

(3) Chronic adverse health effect(s)—a persistent toxic effect(s) that devel-ops over time from a single, prolonged,or repeated exposure to a substance.This effect may result from exposure(s)to a substance that can, in humans,cause sterility, birth defects, harm to adeveloping fetus or to a nursing infant,cancer, allergenic sensitization, dam-age to the nervous system, or a persist-ent adverse effect to any other organsystem.

(4) chronic health hazard(s) (here-after referred to as ‘‘chronic hazard’’)—a health risk to humans, resultantfrom exposure to a substance that maycause a chronic adverse health effect.

(5) Analytical laboratory—a labora-tory having personnel and apparatuscapable of performing quantitative orqualitative analyses of art materials,which may yield information that isused by a toxicologist for evaluation ofpotentially hazardous materials.

(6) Label—a display of written, print-ed, or graphic matter upon the imme-diate container of any art materialproduct. When the product isunpackaged, or is not packaged in animmediate container intended or suit-able for delivery to users, the label canbe a display of such matter directlyupon the article involved or upon a tag

or other suitable labeling device at-tached to the art material.

(7) Producer—the person or entitywho manufactures, processes, or im-ports an art material.

(8) Repackager—the person or entitywho obtains materials from producersand without making changes in suchmaterials puts them in containers in-tended for sale as art materials tousers.

(9) Sensitizer—a substance known tocause, through an allergic process, achronic adverse health effect which be-comes evident in a significant numberof people on re-exposure to the samesubstance.

(10) Toxic—applies to any substancethat is likely to produce personal in-jury or illness to humans through in-gestion, inhalation, or skin contact.

(11) Toxicologist—an individual whothrough education, training, and expe-rience has expertise in the field of toxi-cology, as it relates to human expo-sure, and is either a toxicologist orphysician certified by a nationally rec-ognized certification board.

(12) Bioavailability—the extent thata substance can be absorbed in a bio-logically active form.

(C) Requirements. (1) The producer orrepackager of art materials shall sub-mit art material product formula-tion(s) or reformulation(s) to a toxi-cologist for review, such review to bein accordance with paragraph(b)(8)(l)(D) of this section. The toxi-cologist shall be required to keep prod-uct formulation(s) confidential.

(2) Unless otherwise agreed in writingby the producer or repackager, no oneother than the toxicologists shall haveaccess to the formulation(s); exceptthat the toxicologists shall furnish apatient’s physician, on a confidentialbasis, the information necessary to di-agnose or treat cases of exposure or ac-cidental ingestion.

(3) The producer or repackager, uponadvice given by a toxicologist in ac-cordance with paragraph (b)(8)(i)(D) ofthis section and based upon generallyaccepted, well-established evidencethat a component substance(s) isknown to cause chronic adverse healtheffects adopt precautionary labeling inaccordance with paragraph (b)(8)(i)(E)of this section.


387


(4) Labeling shall conform to any la-beling practices prescribed by federaland state statutes or regulations andshall not diminish the effect of re-quired acute toxicity warnings.

(5) The producer or repackager shallsupply a poison exposure managementinformation source the generic formu-lation information required for dis-semination to poison control centers orshall provide a 24-hour cost-free tele-phone number to poison control cen-ters.

(6) The producer or repackager shallhave a toxicologist review as nec-essary, but at least every 5 years, artmaterial product formulation(s) andassociated label(s) based upon the then-current, generally accepted, well-estab-lished scientific knowledge.

(7) Statement of Conformance—‘‘Con-forms to ASTM Practice D–4236,’’ or‘‘Conforms to ASTM D–4236,’’ or ‘‘Con-forms to the health requirements ofASTM D–4236.’’ This statement may becombined with other conformancestatements. The conformance state-ment should appear whenever practicalon the product; however, it shall alsobe acceptable to place the statementon one or more of the following:

(i) The individual product package,(ii) a display or sign at the point of

purchase,(iii) separate explanatory literature

available on requirements at the pointof purchase,

(iv) a response to a formal request forbid or proposal.

(D) Determination of Labeling. (1) Anart material is considered to have thepotential for producing chronic adversehealth effects if any customary or rea-sonably foreseeable use can result in achronic hazard.

(2) In making the determination, atoxicologist(s) shall take into accountthe following:

(i) Current chemical composition ofthe art material, supplied by an ana-lytical laboratory or by an industrialchemist on behalf of a manufacturer orrepackager.

(ii) Current generally accepted, well-established scientific knowledge of thechronic toxic potential of each compo-nent and the total formulation.

(iii) Specific physical and chemicalform of the art material product, bio-

availability, concentration, and theamount of each potentially chronictoxic component found in the formula-tion.

(iv) Reasonably foreseeable uses ofthe art material product as determinedby consultation with users and otherindividuals who are experienced in useof the material(s), such as teachers, orby market studies, unless such use in-formation has previously been deter-mined with respect to the specific artmaterial(s) under review.

(v) Potential for known synergismand antagonism of the various compo-nents of the formulation.

(vi) Potentially chronic adversehealth effects of decomposition or com-bustion products, if known, from anyreasonably foreseeable use of the haz-ardous art material product.

(vii) Opinions of various regulatoryagencies and scientific bodies, includ-ing the International Agency for Re-search on Cancer and the National Can-cer Institute, on the potential forchronic adverse health effects of thevarious components of the formulation.

(3) Based upon the conclusionreached in conformance with reviewdeterminations set forth herein, thetoxicologist(s) shall recommend pre-cautionary labeling consistent withparagraph (b)(8)(i)(E) of this section.

(E) Labeling Practices—(1) SignalWord. (i) When a signal word for anacute hazard(s) is mandated and achronic hazard(s) exists, the signalword shall be that for the acute hazard.

(ii) When only a chronic hazard(s) ex-ists, the signal word WARNING shallbe used.

(iii) The signal word shall be promi-nently visible and set in bold capitalsin a size equal to or greater than thestatement of potential chronic hazards.

(2) List of Potentially Chronic Haz-ards—Potentially chronic hazards, asdetermined under the procedures ofparagraph (b)(8)(i)(D) of this section,shall be stated substantially in accord-ance with the statements listed inparagraph (b)(8)(i)(F) of this section.Potentially chronic hazards noted shallbe those that are clinically significantand that might be expected with anyreasonably foreseeable use of the artmaterial. The hazards should be


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grouped in the order of relative de-scending severity.

(3) Name of Chronically HazardousComponent(s)—All components andknown decomposition products of theformulation with a potential for chron-ic hazards, as determined under theprocedures of paragraph (b)(8)(i)(D) ofthis section, shall be listed promi-nently. Generically equivalent namesmay be used.

(4) Safe Handling Instructions—Ap-propriate precautionary statements asto work practices, personal protection,and ventilation requirements shall beused substantially conforming withthose listed in paragraph (b)(8)(i)(G) ofthis section.

(5) List of Sensitizing Components—To protect users from known sensitiz-ers found within art materials, eachlabel shall contain a list of those sen-sitizers present in sufficient amountsto contribute significantly to a knownskin or respiratory sensitization.

(6) Combined Statement—If an artmaterial contains more than one com-ponent capable of causing a chronic ad-verse health effect, or if a single chem-ical can cause several different chronicadverse health effects, the potential ef-fects may be combined into one state-ment.

(7) Information Sources—The pre-cautionary label shall contain a state-ment identifying a source for addi-tional health information substantiallyin conformance with one of the phraseslisted below:

(i) For more health information—(24hour cost-free U.S. telephone number),

(ii) Contact a physician for morehealth information, or

(iii) Call your local poison controlcenter for more health information.

(8) Labeling Content, Product Size—Any art material product in a con-tainer larger in size than one fluidounce (30 ml) (if the product is sold byvolume) or one ounce net weight (28 g)(if the product is sold by weight) shallhave full precautionary labeling, as de-scribed in paragraph (b)(8)(i) (E) of thissection. Any art material product in acontainer equal to or smaller than onefluid ounce or one ounce net weightshall have a label that includes a signalword in conformance with paragraph(b)(8)(i)(E)(1) of this section and a list

of potentially harmful or sensitizingcomponents in conformance with para-graphs (b)(8)(i)(E) (3) and (5) of this sec-tion.

(9) The information described inparagraph (b)(8)(i)(E) of this sectionmust appear on:

(i) The outside container or wrapper,if any, unless it is easily legiblethrough the outside container or wrap-per and

(ii) All accompanying literaturewhere there are directions for use,written or otherwise. Where a productthat requires warning labels underparagraphs (b)(8)(i) (D) and (E) of thissection is packed within a point-of-salepackage that obscures the warningstatement(s), the point-of-sale packageshall carry the signal word conformingto paragraph (b)(8)(i)(E)(1) and the fol-lowing wording: ‘‘Contains: (list haz-ardous product(s)) that may be harmfulif misused. Read cautions on individualcontainers carefully. Keep out of thereach of children.’’

(10) Statements required under para-graphs (b)(8)(i) (D) and (E) of this sec-tion must be in the English languageand located prominently in conspicu-ous and legible type in contrast by to-pography, layout, or color with otherprinted matter on the label.

(11) Supplemental Information—Where appropriate, more detailed in-formation that relates to chronic haz-ard(s), such as physical properties, de-composition products, detailed safetyinstructions, or disposal recommenda-tions, shall be included in supple-mental documents, such as MaterialSafety Data Sheets, technical bro-chures, technical data sheets etc.

(F) chronic Hazard Statements

MAY CAUSE STERILITY.CONTACT MAY CAUSE PERMANENT

EYE DAMAGE.MAY BE HARMFUL BY BREATHING

VAPORS/DUSTS.MAY BE HARMFUL IF SWALLOWED.MAY BE HARMFUL BY SKIN CON-

TACT.MAY PRODUCE BIRTH DEFECTS IN

THE DEVELOPING FETUS.MAY BE EXCRETED IN HUMAN

MILK.MAY CAUSE HARM TO THE NURS-

ING INFANT.


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CANCER AGENT! EXPOSURE MAYPRODUCE CANCER.

CANCER AGENT BASED ON TESTSWITH LABORATORY ANIMALS.

POSSIBLE CANCER AGENT BASEDON TESTS WITH LABORATORYANIMALS.

MAY PRODUCE ALLERGIC REAC-TION BY INGESTION/INHALATION/SKIN CONTACT.

MAY PRODUCE NUMBNESS ORWEAKNESS IN THE EXTREMITIES.

EXPOSURE MAY CAUSE (SPECIFYTHE ORGAN(S)) DAMAGE.

HEATING/COMBUSTION MAY CAUSEHAZARDOUS DECOMPOSITIONPRODUCTS.(G) Precautionary Statements

Keep out of reach of children.When using do not eat, drink, or

smoke.Wash hands immediately after use.Avoid inhalation/ingestion/skin con-

tact.Avoid fumes from combustion.Keep container tightly closed when not

in use.Store in well-ventilated area.Wear protective clothing (specify

type).Wear protective goggles/face shield.Wear NIOSH-certified mask for dusts/

mists/fumes.Wear NIOSH-certified respirator with

an appropriate cartridge for (specify).Wear NIOSH-certified supplied-air res-

pirator.Use window exhaust fan to remove va-

pors and ensure adequate cross ven-tilation. (Specify explosion-proof ifnecessary.)

Do not heat above (specify tempera-ture) without adequate ventilation.

Use (specify type) local exhaustinghood.

Do not use/mix with (specify material).(ii) The following shall apply with re-

spect to the standard for art materialsset forth in § 1500.14(b)(8)(i).

(A) The term art material or art mate-rial product shall mean any substancemarketed or represented by the pro-ducer or repackager as suitable for usein any phase of the creation of anywork of visual or graphic art of anymedium. The term does not includeeconomic poisons subject to the Fed-eral Insecticide, Fungicide, andRodenticide Act or drugs, devices, or

cosmetics subject to the Federal Food,Drug, and Cosmetics Act.

(B) The standard referred to in para-graph (b)(8)(i) of this section applies toart materials intended for users of anyage.

(C) Each producer or repackager ofart materials shall describe in writingthe criteria used to determine whetheran art material has the potential forproducing chronic adverse health ef-fects. Each producer or repackagershall submit, to the Commission’s Divi-sion of Regulatory Management,Consumer Product Safety Commission,Washington, DC 20207, the written de-scription of the criteria describedabove and a list of art materials thatrequire hazard warning labels underthis section. Upon request of the Com-mission, a producer or repackager shallsubmit to the Commission product for-mulations.

(D) All art materials that requirechronic hazard labeling pursuant tothis section must include on the labelthe name and United States address ofthe producer or repackager of the artmaterials, an appropriate UnitedStates telephone number that can becontacted for more information on thehazards requiring warning labels underthis section, and a statement that suchart materials are inappropriate for useby children.

(E) If an art material producer or re-packager becomes newly aware of anysignificant information regarding thehazards of an art material or ways toprotect against the hazard, this new in-formation must be incorporated intothe labels of such art materials thatare manufactured after 12 months fromthe date of discovery. If a producer orrepackager reformulates an art mate-rial, the new formulation must be eval-uated and labeled in accordance withthe standard set forth § 1500.14(b)(8)(i).

(F) In determining whether an artmaterial has the potential for produc-ing chronic adverse health effects, in-cluding carcinogenicity and potentialcarcinogenicity, the toxicologist towhom the substance is referred underthe standard described above shall takeinto account opinions of various regu-latory agencies and scientific bodies,including the U.S. Consumer ProductSafety Commission (CPSC), the U.S.


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Environmental Protection Agency(EPA), and the International Agencyfor Research on Cancer (IARC).

(iii) Pursuant to the LHAMA, theCommission has issued guidelineswhich, where possible, specify criteriafor determining when any customaryor reasonably foreseeable use of an artmaterial can result in a chronic haz-ard. These guidelines include criteriafor determining when art materialsmay produce chronic adverse effects inchildren and adults, criteria for deter-mining which substances contained inart materials have the potential forproducing chronic adverse effects andwhat those effects are, criteria for de-termining the bioavailability of chron-ically hazardous substances containedin art materials when the products areused in a customary or reasonably fore-seeable manner, and criteria for deter-mining acceptable daily intake levelsfor chronically hazardous substancescontained in art materials. Becausethese guidelines apply to hazardoussubstances in general as well as to haz-ardous substances in art materials, theguidelines are set forth in § 1500.135 anda definition of ‘‘chronic toxicity’’ isprovided in § 1500.3(c)(2)(ii) as part ofsupplementation of the term ‘‘toxic’’ insection 2(q) of the FHSA.

(iv) Policies and interpretations.(A) For purposes of enforcement pol-

icy, the Commission will not consideras sufficient grounds for bringing anenforcement action under the Labelingof Hazardous Art Materials Act(‘‘LHAMA’’) the failure of the followingtypes of products to meet the require-ments of § 1500.14(b)(8) (i) through (iii).

(1) Products whose intended generaluse is not to create art (e.g., commonwood pencils, and single colored pens,markers, and chalk), unless the par-ticular product is specificallypackaged, promoted, or marketed in amanner that would lead a reasonableperson to conclude that it is intendedfor use as an art material. Factors theCommission would consider in makingthis determination are how an item ispackaged (e.g., packages of multiplecolored pencils, chalks, or markers un-less promoted for non-art materialsuses are likely to be art materials),how it is marketed and promoted (e.g.,pencils and pens intended specifically

for sketching and drawing are likely tobe art materials), and where it is sold(e.g., products sold in an art supplystore are likely to be art materials).The products described in this para-graph do not meet the statutory defini-tion of ‘‘art material.’’

(2) Tools, implements, and furnitureused in the creation of a work of artsuch as brushes, chisels, easels, pictureframes, drafting tables and chairs, can-vas stretchers, potter’s wheels, ham-mers, air pumps for air brushes, kilns,and molds.

(3) Surface materials upon which anart material is applied, such as color-ing books and canvas, unless, as a re-sult of processing or handling, theconsumer is likely to be exposed to achemical in or on the surface materialin a manner which makes that chemi-cal susceptible to being ingested, ab-sorbed, or inhaled.

(4) The following materials whetherused as a surface or applied to one, un-less, as a result of processing or han-dling, the consumer is likely to be ex-posed to a chemical in or on the sur-face material in a manner which makesthat chemical susceptible to being in-gested, absorbed, or inhaled: paper,cloth, plastics, films, yarn, threads,rubber, sand, wood, stone, tile, ma-sonry, and metal.

(B) For purposes of LHAMA enforce-ment policy, the Commission will en-force against materials including, butnot limited to, paints, crayons, coloredpencils, glues, adhesives, and putties, ifsuch materials are sold as part of anart, craft, model, or hobby kit. TheCommission will enforce the LHAMArequirements against paints or othermaterials sold separately which are in-tended to decorate art, craft, model,and hobby items. Adhesives, glues, andputties intended for general repair orconstruction uses are not subject toLHAMA. However, the Commission willenforce the LHAMA requirementsagainst adhesives, glues, and puttiessold separately (not part of a kit) ifthey are intended for art and craft andmodel construction uses. This para-graph (b)(8)(iv)(B) applies to productsintroduced into interstate commerceon or after August 14, 1995.

(C) Commission regulations at§ 1500.14(b)(8)(i)(C)(7) require that a


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statement of conformance appear withart materials that have been reviewedin accordance with the Commissionstandard. The Commission interpretsthis provision to require a conformancestatement regardless of the presence ofany chronic hazard warnings.

(D) Nothing in this enforcementstatement should be deemed to alterany of the requirements of the FederalHazardous Substances Act (‘‘FHSA’’),such as, but not limited to, the require-ment that any hazardous substance in-tended or packaged in a form suitablefor household use must be labeled inaccordance with section 2(p) of theFHSA.

APPENDIX A TO § 1500.14(b)(8)—GUIDE-LINES FOR A CERTIFYING ORGANIZA-TION (NOT MANDATORY)

(a) The term ‘‘certifying organization,’’ asused in this paragraph, refers to an organiza-tion or an institute that, after assuring thatall provisions are met, certifies that an artmaterial does conform to the labeling re-quirements of this practice.

(b) The certifying body may be funded bymember manufacturers, but should includeusers or their representatives, as well asmanufacturers’ chemists, on its technicaland certifying committees.

(c) Representative samples of art mate-rials, labeled as conforming to this sectionand bought at retail, should be analyzed atrandom and from time to time by an analyt-ical laboratory to ensure they are the sameas the formulation used by the toxi-cologist(s) for determining labeling require-ments.

(d) The methods used by the toxicologist(s)in review and determination of the need andcontent of precautionary labeling for poten-tially chronic adverse health effects shouldbe periodically reviewed by an advisoryboard composed of not less than three ormore than five toxicologists, at least one ofwhom is certified in toxicology by a nation-ally recognized certification board.

(e) In cases where there is disagreement byparticipating producers or participatingusers, with the determination of the toxi-cologist(s), there should be a method where-by the toxicologist’s decision can be pre-sented to the advisory board of toxicologistsfor arbitration.

[38 FR 27012, Sept. 27, 1973, as amended at 41FR 22934, June 8, 1976; 48 FR 16, Jan. 3, 1983;53 FR 3018, Feb. 3, 1988; 57 FR 46669, Oct. 9,1992; 60 FR 8193, Feb. 27, 1995; 61 FR 19829,May 3, 1996; 61 FR 33175, June 26, 1996]

EFFECTIVE DATE NOTES: 1. At 61 FR 19829,May 3, 1996, § 1500.14 was amended by redesig-

nating paragraphs (b)(6) (i) and (ii) as (b)(6)(i)(A) and (B), amending newly designatedparagraph (b)(6)(i)(A), amending newly des-ignated paragraph (b)(6)(i)(B) by adding‘‘packaged before November 3, 1997’’ after‘‘charcoal’’, and adding a new paragraph(b)(6)(ii), effective Nov. 3, 1997.

2. At 61 FR 33175, June 26, 1996, a correctiondocument was published that amended para-graph (b)(6)(i)(A) by adding ‘‘packaged beforeNovember 3, 1997’’ after ‘‘products’’ andchanging ‘‘[insert date that is 18 monthsafter publication]’’ to read ‘‘November 3,1997,’’ and amending paragraph (b)(6)(ii)(B)by changing ‘‘53⁄16 inches’’ to read ‘‘513⁄16

inches’’, effective Nov. 3, 1997.

§ 1500.15 Labeling of fire extinguish-ers.

When a substance or mixture of sub-stances labeled for use in or as a fireextinguisher produces substances thatare toxic within the meaning of§ 1500.3(c) (1) and (2) when used accord-ing to label directions to extinguish afire, the containers for such substancesshall bear the following labeling:

(a) When substances are producedthat meet the definition of highly toxicin § 1500.3(c)(1), the signal word ‘‘Dan-ger’’ and the statement of hazard ‘‘Poi-sonous gases formed when used to ex-tinguish flame or on contact withheat’’ are required labeling.

(b) When substances are producedthat meet the definition of toxic in§ 1500.3(c)(2), the signal word ‘‘Caution’’or ‘‘Warning’’ and the statement ofhazard ‘‘Dangerous gas formed whenused to extinguish flame or on contactwith heat’’ are required labeling.

(c) Regardless of whether paragraph(a) or (b) of this section applies, anysubstance or mixture of substances la-beled for use as a fire extinguisherthat, if applied to an electrical fire,would subject the user to the likeli-hood of electrical shock shall be con-spicuously labeled ‘‘Caution: Do notuse on electrical wires.’’

(d) The statements specified in para-graphs (a), (b), and (c) of this sectionshall be in addition to any other thatmay be required under the act. All suchsubstances or mixtures of substancesshall also bear the additional state-ments ‘‘Use in an enclosed place maybe fatal’’ and ‘‘Do not enter area untilwell ventilated and all odor of chemi-cal has disappeared.’’


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§ 1500.17 Banned hazardous sub-stances.

(a) Under the authority of section2(q)(1)(B) of the act, the Commissiondeclares as banned hazardous sub-stances the following articles becausethey possess such a degree or nature ofhazard that adequate cautionary label-ing cannot be written and the publichealth and safety can be served only bykeeping such articles out of interstatecommerce:

(1) Mixtures that are intended pri-marily for application to interior ma-sonry walls, floors, etc., as a water re-pellant treatment and that are ‘‘ex-tremely flammable’’ within the mean-ing of section 2(1) of the act (repeatedin § 1500.3(b)(10)).

(2) Carbon tetrachloride and mixturescontaining it (including carbon tetra-chloride and mixtures containing itused in fire extinguishers), excludingunavoidable manufacturing residues ofcarbon tetrachloride in other chemi-cals that under reasonably foreseeableconditions of use do not result in an at-mospheric concentration of carbon tet-rachloride greater than 10 parts permillion.

(3) Fireworks devices intended toproduce audible effects (including butnot limited to cherry bombs, M–80 sa-lutes, silver salutes, and other largefirecrackers, aerial bombs, and otherfireworks designed to produce audibleeffects, and including kits and compo-nents intended to produce such fire-works) if the audible effect is producedby a charge of more than 2 grains ofpyrotechnic composition; except thatthis provision shall not apply to suchfireworks devices if all of the followingconditions are met:

(i) Such fireworks devices are distrib-uted to farmers, ranchers, or growersthrough a wildlife management pro-gram administered by the U.S. Depart-ment of the Interior (or by equivalentState or local government agencies);and

(ii) Such distribution is in responseto a written application describing thewildlife management problem that re-quires use of such devices, is of a quan-tity no greater than required to con-trol the problem described, and iswhere other means of control are un-available or inadequate. (See also

§ 1500.14(b)(7); § 1500.17(a) (8) and (9);§ 1500.83(a)(27); § 1500.85(a)(2); and part1507).

(4) Liquid drain cleaners containing10 percent or more by weight of sodiumand/or potassium hydroxide; exceptthat this subparagraph shall not applyto such liquid drain cleaners ifpackaged in accordance with a stand-ard for special packaging of such arti-cles promulgated under the Poison Pre-vention Packaging Act of 1970 (Pub. L.91–601, 84 Stat. 1670–74 (15 U.S.C. 1471–76)).

(5) Products containing soluble cya-nide salts, excluding unavoidable man-ufacturing residues of cyanide salts inother chemicals that under reasonableand foreseeable conditions of use willnot result in a concentration of cya-nide greater than 25 parts per million.

(6)(i) Any paint or other similar sur-face-coating material intended, orpackaged in a form suitable, for use inor around the household that:

(A) Is shipped in interstate commerceafter December 31, 1973, and containslead compounds of which the lead con-tent (calculated as the metal) is in ex-cess of 0.06 percent of the total weightof the contained solids or dried paintfilm; or

(B) Is shipped in interstate commerceafter December 31, 1972, and containslead compounds of which the lead con-tent (calculated as the metal) is in ex-cess of 0.5 percent of the total weightof the contained solids or dried paintfilm.

(C) [Reserved](D) The provisions of paragraph

(a)(6)(i) of this section do not apply toartists’ paints and related materials.

(ii) Any toy or other article intendedfor use by children that:

(A) Is shipped in interstate commerceafter December 31, 1973, and bears anypaint or other similar surface-coatingmaterial containing lead compounds ofwhich the lead content (calculated asthe metal) is in excess of 0.06 percent ofthe total weight of the contained solidsor dried paint film; or

(B) Is shipped in interstate commerceafter December 31, 1972, and bears anypaint or other similar surface-coatingmaterial containing lead compounds ofwhich the lead content (calculated asthe metal) is in excess of 0.5 percent of


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the total weight of the contained solidsor dried paint film.

(iii) Since the Commission has issuedcomprehensive regulations for lead-containing paint and certain consumerproducts bearing such paint at the 0.06percent level under the ConsumerProduct Safety Act (see 16 CFR part1303), paragraphs (i) and (ii) of§ 1500.17(a)(6) are revoked as to the sub-ject products manufactured after Feb-ruary 27, 1978.

NOTE: The effective date of paragraphs(a)(6)(i)(A) and (a)(6)(ii)(A) was stayed by anorder published in the FEDERAL REGISTER ofAugust 10, 1972 (37 FR 16078).

(7) General-use garments containingasbestos (other than garments having abona fide application for personal pro-tection against thermal injury and soconstructed that the asbestos fiberswill not become airborne under reason-ably foreseeable conditions of use).

(8) Firecrackers designed to produceaudible effects, if the audible effect isproduced by a charge of more than 50milligrams (.772 grains) of pyrotechniccomposition (not including fire-crackers included as components of arocket), aerial bombs, and devices thatmay be confused with candy or otherfoods, such as ‘‘dragon eggs,’’ and‘‘cracker balls’’ (also known as ‘‘ball-type caps’’), and including kits andcomponents intended to produce suchfireworks except such devices whichmeet all of the following conditions:

(i) The fireworks devices are distrib-uted to farmers, ranchers, or growersthrough a wildlife management pro-gram administered by the U.S. Depart-ment of Interior (or by equivalentState or local governmental agencies);and

(ii) Such distribution is in responseto a written application describing thewildlife management problem that re-quires use of such devices, is of a quan-tity no greater than required to con-trol the problem described, and iswhere other means of control is un-available or inadequate. (See also§ 1500.17(a) (3) and (9)).

(9) All fireworks devices, other thanfirecrackers, including kits and compo-nents intended to produce such fire-works, not otherwise banned under theact, that do not comply with the appli-cable requirements of part 1507 of this

chapter, except fireworks deviceswhich meet all the following condi-tions:

(i) The fireworks devices are distrib-uted to farmers, ranchers, or growersthrough a wildlife management pro-gram administered by the U.S. Depart-ment of the Interior (or by equivalentState or local government agencies);and

(ii) Such distribution is in responseto a written application describing thewildlife management problem that re-quires use of such devices, is of a quan-tity no greater than required to con-trol the problem described, and iswhere other means of control is un-available or inadequate. (See also§ 1500.17(a) (3) and (8)).

(10) Self-pressurized products in-tended or suitable for household usethat contain vinyl chloride monomeras an ingredient or in the propellantmanufactured or imported on or afterOctober 7, 1974. (See also § 1500.17(a) (3)and (8)).

(11)(i) Reloadable tube aerial shellfireworks devices that use shells largerthan 1.75 inches in outer diameter andthat are imported on or after October8, 1991.

(ii) Findings. (A) General. In order toissue a rule under section 2(q)(1) of theFederal Hazardous Substances Act(‘‘FHSA’’), 15 U.S.C. 1261(q)(1),classifying a substance or article as abanned hazardous substance, the FHSArequires the Commission to make cer-tain findings and to include these find-ings in the regulation. These findingsare discussed below.

(B) Voluntary standard. Although avoluntary standard relating to the riskof injury associated with reloadabletube aerial shells has been adopted, ithas not been implemented. Thus, theCommission is not required to makefindings covering the likelihood thatthe voluntary standard would result inelimination or adequate reduction ofthe risk of injury or that there wouldbe substantial compliance with the vol-untary standard.

(C) Relationship of benefits to costs.The Commission estimates that the re-moval of large reloadable shells fromthe market is likely to virtually elimi-nate the number of associated injuries,with only a slight offsetting increase in


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the number of injuries due to the use ofsubstitute Class C fireworks productsavailable to consumers. The estimatednet benefits range from essentially zeroto close to $1 million annually. The an-nual costs of a ban are estimated to bevery low. Included are potential coststo foreign manufacturers and U.S. im-porters from sales losses, productionchanges, and inventory retrofitting,and slightly reduced market choicesfor consumers who purchase aerial dis-play fireworks. Costs to each of thesesectors are estimated to be slight, andare reduced to the extent that alter-native products are perceived as ade-quate substitutes for large reloadableshells. Thus, the Commission finds thatthe benefits expected from the regula-tion bear a reasonable relationship toits costs.

(D) Least burdensome requirement. TheCommission considered several alter-natives to the ban. These included: De-sign or performance criteria; addi-tional or alternative labeling; inclu-sion of some reloadable shells 1.75inches or smaller in the ban; and no ac-tion in reliance on the voluntarystandard. The Commission determinedthat a ban of reloadable shells largerthan 1.75 inches in outer diameter isthe least burdensome alternative thatwould prevent or adequately reduce therisk of injury.

(1) Regarding design or performancecriteria, the Commission considered re-quirements similar to those stated inthe voluntary standard of the Amer-ican Fireworks Standards Laboratory(‘‘AFSL’’). However, such criteria mayincrease the cost of the product andwould not address all factors involvedin the incidents. Further, concernsexist about the feasibility of criteriaand quality control.

(2) Regarding additional or alter-native labeling, the users’ perceptionand experience concerning the amountof time available to get away may leadthem to disregard an inconsistentwarning. There are no data to suggestthat a significant number, if any, inci-dents would be avoided if largereloadable shells carried more detailedlabels or instructions than they cur-rently do. It cannot be concluded thatpotential benefits would be greaterthan zero.

(3) The Commission considered in-cluding reloadable shells that are 1.75inches or less in outer diameter andhave the ‘‘equivalent explosive power’’of larger shells. A kinetic energy levelof 70 joules was considered to evaluateexplosive power. However, any poten-tial benefits are uncertain since theCommission concluded that a clear re-lation between kinetic energy and in-jury potential could not be established.Also, costs could be slightly higher.

(4) The Commission also consideredimposing no mandatory requirementson large reloadable shells and relyinginstead on the AFSL voluntary stand-ard. However, it is uncertain whetherany net benefits to consumers wouldresult from this alternative, since thelevel of injury reduction could be nearzero if, as is probable, some firms chosenot to conform with some or all of theAFSL standard.

(12)(i) Large multiple-tube devices. Mul-tiple-tube mine and shell fireworks de-vices that first enter commerce or areimported on or after March 26, 1997,that have any tube measuring 1.5inches (3.8 cm) or more in inner diame-ter, and that have a minimum tip angleless than 60 degrees when tested in ac-cordance with the procedure of § 1507.12of this part.

(ii) Findings—(A) General. In order toissue a rule under the section 2(q)(1) ofthe FHSA, 15 U.S.C. 1261(q)(1),classifying a substance or article as abanned hazardous substance, the FHSArequires the Commission to make cer-tain findings and to include these inthe regulation. These findings are dis-cussed in paragraphs (a)(12)(ii) (B)through (D) of this section.

(B) Voluntary standard. (1) One alter-native to the tip-angle requirementthat the Commission considered is totake no mandatory action, and to de-pend on a voluntary standard. TheAmerican Fireworks Safety Labora-tory (AFSL) has a standard for minesand shells intended to address the po-tential tip-over hazard associated withmultiple-tube fireworks devices.AFSL’s Voluntary Standard for Minesand Shells—Single or Multiple Shot re-quires that large multiple-tube devicesnot tip over (except as the result of thelast shot) when shot on a 2-inch thick


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medium-density foam pad. The Com-mission cannot conclude that AFSL’sexisting voluntary standard adequatelyreduces the risk of injury from largedevices that tip over while functioning.The Commission’s tests using poly-urethane foam did not find sufficientagreement between performance onfoam and on grass. No other data areavailable to show that this dynamictest is reliable.

(2) In addition, even if the AFSLstandard is effective, the Commissiondoes not believe that compliance withthe standard will be adequate. AFSLreports that it has been testing in ac-cordance with its standard since Janu-ary 1994. However, the results ofCPSC’s compliance testing indicatethat multiple-tube devices still tipover while functioning. In fiscal year1994, all 24 imported devices the Com-mission tested, and 1 of 8 domestic de-vices, tipped over while functioning. Infiscal year 1995, 22 of 27 imported de-vices and 1 of 5 domestic devices tippedover during Commission testing. TheCommission finds that there is un-likely to be substantial compliancewith the voluntary standard applicableto multiple-tube devices.

(C) Relationship of benefits to costs.The Commission estimates that the 60-degree tip-angle standard will elimi-nate the unreasonable tip-over riskposed by these devices. This will pro-vide benefits of saving one life aboutevery 3 years, and preventing an un-known number of nonfatal injuries.The annual cost of modifying affecteddevices is estimated to be between $1.5million and $2.7 million. The Commis-sion finds that the benefits from theregulation bear a reasonable relation-ship to its costs.

(D) Least burdensome requirement. TheCommission considered the followingalternatives: a ban of all multiple-tubedevices with inner tube diameters 1.5inches or greater; a dynamic perform-ance standard; additional labeling re-quirements; and relying on the vol-untary standard. Although a ban of alllarge multiple-tube devices would ad-dress the risk of injury, it would bemore burdensome than the tip-anglestandard. The Commission was unableto develop a satisfactory dynamicstandard that would reduce the risk of

injury. Neither additional labeling re-quirements nor reliance on the vol-untary standard would adequately re-duce the risk of injury. Thus, the Com-mission finds that a standard requiringlarge multiple-tube devices to have aminimum tip angle greater than 60 de-grees is the least burdensome require-ment that would prevent or adequatelyreduce the risk of injury.

(Secs. 2(f)(1), (A), (B), (g), (q)(1)(B), 3(a), 74Stat. 372, 374, as amended 80 Stat. 1304–05, 83Stat. 187–189, 90 Stat. 503 (15 U.S.C. 1261,1262); sec. 701 (e), (f), (g), 52 Stat. 1055–56, asamended 70 Stat. 919, 72 Stat. 948 (21 U.S.C.371 (e), (f), (g)), sec. 30(a), 86 Stat. 1231 (15U.S.C. 2079(a)))

[38 FR 27012, Sept. 27, 1973, as amended at 38FR 27514, Oct. 4, 1973; 38 FR 31520, Nov. 15,1973; 39 FR 30114, Aug. 21, 1974; 39 FR 42903,Dec. 9, 1974; 41 FR 22935, June 8, 1976; 42 FR44202, Sept. 1, 1977; 43 FR 12310, Mar. 24, 1978;48 FR 16, Jan. 3, 1983; 56 FR 37837, Aug. 9,1991; 61 FR 13095, Mar. 26, 1996; 61 FR 18245,Apr. 25, 1996]

EFFECTIVE DATE NOTES: 1. At 61 FR 13095,Mar. 26, 1996, in § 1500.17, paragraph (a)(12)was added, effective Mar. 26, 1997.

2. At 61 FR 18245, Apr. 25, 1996, in § 1500.17,paragraph (a)(12)(i) was revised, effectiveMar. 26, 1997.

§ 1500.18 Banned toys and otherbanned articles intended for use bychildren.

(a) Toys and other articles presentingmechanical hazards. Under the author-ity of sections 2(f)(1)(D) and 24 of theact and pursuant to the provisions ofsection 3(e) of the act, the Commissionhas determined that the followingtypes of toys or other articles intendedfor use by children present a mechani-cal hazard within the meaning of sec-tion 2(s) of the act because in normaluse, or when subjected to reasonablyforeseeable damage or abuse, the de-sign or manufacture presents an unrea-sonable risk of personal injury or ill-ness:

(1) Any toy rattle containing, eitherinternally or externally, rigid wires,sharp protrusions, or loose small ob-jects that have the potential for caus-ing lacerations, puncture wound in-jury, aspiration, ingestion, or other in-jury. (But see § 1500.86(a)(1)).

(2) Any toy having noisemaking com-ponents or attachments capable of


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being dislodged by the operating fea-tures of the toy or capable of being de-liberately removed by a child, whichtoy has the potential for causing lac-eration, puncture wound injury, aspira-tion, ingestion, or other injury.

(3) Any doll, stuffed animal, or othersimilar toy having internal or externalcomponents that have the potential forcausing laceration, puncture wound in-jury, or other similar injury. (But see§ 1500.86(a)(2)); (See also §§ 1500.48 and1500.49).

(4) Lawn darts and other similarsharp-pointed toys usually intended foroutdoor use and having the potentialfor causing puncture wound injury.

(5) Caps (paper or plastic) intendedfor use with toy guns and toy guns notintended for use with caps if such capswhen so used or such toy guns produceimpulse-type sound at a peak pressurelevel at or above 138 decibels, referredto 0.0002 dyne per square centimeter,when measured in an anechoic chamberat a distance of 25 centimeters (or thedistance at which the sound source or-dinarily would be from the ear of thechild using it if such distance is lessthan 25 centimeters) in any directionfrom the source of the sound. Thisparagraph is an interim regulationpending further investigation to deter-mine whether prevention of damage tothe hearing of children requires revi-sion hereof.

(6) Any article known as a ‘‘baby-bouncer,’’ ‘‘walker-jumper,’’ or ‘‘baby-walker’’ and any other similar article(referred to in this paragraph as ‘‘arti-cle(s)’’) which is intended to supportvery young children while sitting walk-ing, bouncing, jumping, and/or reclin-ing, and which because of its design hasany exposed parts capable of causingamputation, crushing, lacerations,fractures, hematomas, bruises, or otherinjuries to fingers, toes, or other partsof the anatomy of young children. In-cluded among, but not limited to, thedesign features of such articles whichclassify the articles as banned hazard-ous substances are:

(i) The areas about the point on eachside of the article where the framecomponents are joined together toform an ‘‘X’’ shape capable of produc-ing a scissoring, shearing, or pinchingeffect.

(ii) Other areas where two or moreparts are joined in such a manner as topermit a rotational movement capableof exerting a scissoring, shearing, orpinching effect.

(iii) Exposed coil springs which mayexpand sufficiently to allow an infant’sfinger, toe, or any other part of theanatomy to be inserted, in whole or inpart, and injured by being caught be-tween the coils of the spring or be-tween the spring and another part ofthe article.

(iv) Holes in plates or tubes whichprovide the possibility of insertion, inwhole or in part, of a finger, toe, or anypart of the anatomy that could then beinjured by the movement of anotherpart of the article.

(v) Design and construction that per-mits accidental collapse while in use.(But see § 1500.86(a)(4)).

(7) Toys usually known as clackerballs and consisting of two balls ofplastic or another material connectedby a length of line or cord or similarconnector (referred to as ‘‘cord’’ in§ 1500.86(a)(5)), intended to be operatedin a rhythmic manner by an upwardand downward motion of the hand sothat the two balls will meet forcefullyat the top and bottom of twosemicircles thus causing a ‘‘clacking’’sound, which toys present a mechani-cal hazard because their design or man-ufacture presents an unreasonable riskof personal injury from fracture, frag-mentations, or disassembly of the toyand from propulsion of the toy or itspart(s). (But see § 1500.86(a)(5).) Thisdoes not include products that are con-structed so that the connecting mem-bers consist of plastic rods integrallymolded to the balls and are mounted ona pivot so that movement of the ballsis essentially limited to a single plane.

(8) Any pacifier that does not meetthe requirements of 16 CFR part 1511and that is introduced into interstatecommerce after February 26, 1978.

(9) Any toy or other article intendedfor use by children under 3 years of agewhich presents a choking, aspiration,or ingestion hazard because of smallparts as determined by part 1501 of thischapter and which is introduced intointerstate commerce after January 1,1980. For purposes of this regulation,introduction into interstate commerce


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is defined as follows: A toy or chil-dren’s article manufactured outside theUnited States is introduced into inter-state commerce when it is firstbrought within a U.S. port of entry. Atoy or children’s article manufacturedin the United States is introduced intointerstate commerce (1) at the time ofits first interstate sale, or (2) at thetime of its first intrastate sale if one ormore of its components and/or raw ma-terials were received interstate, which-ever occurs earlier. Part 1501 definesthe term ‘‘toy or other article intendedfor use by children under 3,’’ as used inthis regulation, and exempts certainproducts from banning under this regu-lation.

(10)–(11) [Reserved](12) Any bicycle as defined in

§ 1512.2(a) of this chapter (except a bicy-cle that is a ‘‘track bicycle’’ or a ‘‘one-of-a-kind bicycle’’ as defined in § 1512.2(d) and (e) of this chapter) that is in-troduced into interstate commerce onor after May 11, 1976, and that does notcomply with the requirements of part1512 of this chapter, except for§§ 1512.5(c)(3), 1512.9(a), 1512.18(e) and1512.18(f) which become effective No-vember 13, 1976.

(13) Any full-size baby crib (as de-fined in § 1508.1(a) of this chapter) thatis introduced into interstate commerceon or after February 1, 1974, and thatdoes not comply with the requirementsof §§ 1508.2 through 1508.10 of this chap-ter; and any full size baby crib (as de-fined in § 1508.1(a) of this chapter) thatis manufactured on or after April 27,1983, and that does not comply with§§ 1508.2 through 1508.11 of this chapter.

(14) Any non-full-size baby crib (asdefined in § 1509.2 of this chapter) thatis introduced into interstate commerceafter August 9, 1976, and that does notcomply with the requirements of§§ 1509.3 through 1509.12 of this chapter;and any non-full size baby crib (as de-fined in § 1509.2 of this chapter) that ismanufactured on or after April 27, 1983,and that does not comply with §§ 1509.3through 1509.13 of this chapter.

(15) Any rattle (as defined in § 1510.2of this chapter) that is introduced intointerstate commerce on or after Au-gust 21, 1978, and that does not complywith the requirements of part 1510 ofthis chapter. For purposes of the regu-

lation, introduction into interstatecommerce is defined as follows: A rat-tle manufactured outside the UnitedStates is introduced into interstatecommerce when it is first broughtwithin a U.S. port of entry. A rattlemanufactured in the United States isintroduced into interstate commerce(a) at the time of its first interstatesale, or (b) at the time of its first intra-state sale if one or more of its compo-nents and/or raw materials were re-ceived interstate.

(16)(i) Any article known as an ‘‘in-fant cushion’’ or ‘‘infant pillow,’’ andany other similar article, which has allof the following characteristics:

(A) Has a flexible fabric covering.The term fabric includes those mate-rials covered by the definition of ‘‘fab-ric’’ in section 2(f) of the FlammableFabrics Act, 15 U.S.C. 1191(f).

(B) Is loosely filled with a granularmaterial, including but not limited to,polystyrene beads or pellets.

(C) Is easily flattened.(D) Is capable of conforming to the

body or face of an infant.(E) Is intended or promoted for use

by children under one year of age.(ii) Findings—(A) General. In order to

issue a rule under section 2(q)(1) of theFederal Hazardous Substance Act(FHSA), 15 U.S.C. 1261(q)(1), classifyinga substance or article as a banned haz-ardous substance, the FHSA requiresthe Commission to make certain find-ings and to include these findings inthe regulation. These findings are dis-cussed in paragraphs (a)(16)(ii) (B)through (D) of this section.

(B) Voluntary standard. No findingsconcerning compliance with or ade-quacy of a voluntary standard are nec-essary since no voluntary standard ad-dressing infant cushions has beenadopted or implemented.

(C) Relationship of benefits to costs.The Commission estimates that the re-moval of infant cushions from the mar-ket will result in total annual benefitsof approximately five million dollars.The potential costs to businesses areexpected to be offset by production ofother products, and the potential coststo consumers are likely to be offset bythe availability of substitutes for acomparable price.


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(D) Least burdensome requirement. TheCommission considered labeling and adesign or performance standard as al-ternatives to the ban. The Commissiondoes not believe that any form of label-ing would have a significant effect inpreventing the hazard associated withinfant cushions. The Commission alsoconcluded that no feasible standard ex-ists that would address the hazard.Thus, the Commission determined thata ban of infant cushions is the leastburdensome alternative that wouldprevent or adequately reduce the riskof injury.

(17) Any ball intended for childrenunder three years of age that, underthe influence of its own weight, passes,in any orientation, entirely through acircular hole with a diameter of 1.75inches (44.4 mm.) in a rigid template 1⁄4inches (6 mm.) thick. In testing toevaluate compliance with this para-graph, the diameter of opening in theCommission’s test template shall be nogreater than 1.75 inches (44.4 mm.).

(i) For the purposes of this para-graph, the term ‘‘ball’’ includes anyspherical, ovoid, or ellipsoidal objectthat is designed or intended to bethrown, hit, kicked, rolled, dropped, orbounced. The term ‘‘ball’’ includes anyspherical, ovoid, or ellipsoidal objectthat is attached to a toy or article bymeans of a string, elastic cord, or simi-lar tether. The term ‘‘ball’’ also in-cludes any multi-sided object formedby connecting planes into a generallyspherical, ovoid, or ellipsoidal shapethat is designated or intended to beused as a ball, and any novelty item ofa generally spherical, ovoid, or ellip-soidal shape that is designated or in-tended to be used as a ball.

(ii) The term ‘‘ball’’ does not includedice, or balls permanently enclosed in-side pinball machines, mazes, or simi-lar outer containers. A ball is perma-nently enclosed if, when tested in ac-cordance with 16 CFR 1500.52, the ballis not removed from the outer con-tainer.

(iii) In determining whether such aball is intended for use by childrenunder three years of age, the criteriaspecified in 16 CFR 1501.2(b) and the en-forcement procedure established by 16CFR 1501.5 shall apply.

(b) Electrically operated toys and otherelectrical operated children’s articles pre-senting electrical, thermal, and/or certainmechanical hazards. Under the author-ity of section 2(f)(1)(D) of the act andpursuant to provisions of section 3(e) ofthe act, the Commission has deter-mined that the following types of elec-trically operated toys or other elec-trically operated articles intended foruse by children present electrical, ther-mal, and/or certain mechanical hazardswithin the meaning of section 2 (r), (s),and/or (t) of the act because in normaluse or when subjected to reasonablyforeseeable damage or abuse, the de-sign or manufacture may cause per-sonal injury or illness by electric shockand/or presents an unreasonable risk ofpersonal injury or illness because ofheat as from heated parts, substances,or surfaces, or because of certain me-chanical hazards.

(1) Any electrically operated toy orother electrically operated article in-tended for use by children (as definedin § 1505.1(a)(1)) that is introduced intointerstate commerce and which doesnot comply with the requirements ofpart 1505 of this chapter.

NOTE: Paragraph (b)(1) was originally pro-mulgated as 21 CFR 191.9a(b)(1) with an effec-tive date of September 3, 1973 (38 FR 6138).

(c) Toys and other articles (not elec-trically operated) presenting electric haz-ards. Under the authority of section2(f)(1)(D) of the act and pursuant toprovisions of section 3(e) of the act, theCommission has determined that thefollowing types of toys or other arti-cles intended for use by children (notelectrically operated) present an elec-trical hazard within the meaning ofsection 2(r) of the act.

(1) Any kite 10 inches or greater inany dimension constructed of alu-minized polyester film or any kite hav-ing a tail or other component consist-ing of a piece of aluminized polyesterfilm 10 inches or greater in any dimen-sion presents an electrical hazard andis a banned hazardous substance be-cause its design (specifically its sizeand electrical conductivity) presents arisk of personal injury from electricshock due to its ability to conductelectricity and to become entangled in


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or otherwise contact high voltage elec-tric power lines.

(15 U.S.C. 1261 (f)(1)(D), (g)(1)(A), (r); 15 U.S.C.1262(e)(1); 15 U.S.C. 2079(a))[38 FR 27012, Sept. 27, 1973, as amended at 38FR 30105, Nov. 1, 1973; 38 FR 32132, Nov. 21,1973; 41 FR 4144, Jan. 28, 1976; 41 FR 6240, Feb.12, 1976; 42 FR 36823, July 18, 1977; 42 FR 61594,Dec. 6, 1977; 43 FR 22005, May 23, 1978; 44 FR34903, June 15, 1979; 44 FR 55819, Sept. 28, 1979;48 FR 16, Jan. 3, 1983; 48 FR 57268, Dec. 29,1983; 53 FR 46839, Nov. 18, 1988; 57 FR 27915,June 23, 1992; 59 FR 9076, Feb. 25, 1994; 60 FR10752, Feb. 27, 1995]

§ 1500.19 Misbranded toys and otherarticles intended for use by chil-dren.

(a) Definitions. For the purposes ofthis section, the following definitionsshall apply.

(1) Ball means a spherical, ovoid, orellipsoidal object that is designed orintended to be thrown, hit, kicked,rolled, dropped, or bounced. The term‘‘ball’’ includes any spherical, ovoid, orellipsoidal object that is attached to atoy or article by means of a string,elastic cord, or similar tether. Theterm ‘‘ball’’ also includes any multi-sided object formed by connectingplanes into a generally, spherical,ovoid, or ellipsoidal shape that is des-ignated or intended to be used as aball, and any novelty item of a gen-erally spherical, ovoid, or ellipsoidalshape that is designated or intended tobe used as a ball. The term ‘‘ball’’ doesnot include dice, or balls permanentlyenclosed inside pinball machines,mazes, or similar outer containers. Aball is permanently enclosed if, whentested in accordance with 16 CFR1500.53, it is not removed from theouter container.

(2) Small ball means a ball that, underthe influence of its own weight, passes,in any orientation, entirely through acircular hole with a diameter of 1.75inches (44.4 mm.) in a rigid template 1⁄4inches (6 mm.) thick. In testing toevaluate compliance with this regula-tion, the diameter of opening in theCommission’s test template shall be nogreater than 1.75 inches (44.4 mm.).

(3) Latex balloon means a toy or deco-rative item consisting of a latex bagthat is designed to be inflated by air orgas. The term does not include inflat-able children’s toys that are used in

aquatic activities such as rafts, waterwings, swim rings, or other similaritems.

(4) Marble means a ball made of ahard material, such as glass, agate,marble or plastic, that is used in var-ious children’s games, generally as aplaying piece or marker. The term‘‘marble’’ does not include a marblepermanently enclosed in a toy or game.A marble is permanently enclosed if,when tested in accordance with 16 CFR1500.53, it is not removed from the toyor game.

(5) Small part means any objectwhich, when tested in accordance withthe procedures contained in 16 CFR1501.4(a) and 1501.4(b)(1), fits entirelywithin the cylinder shown in Figure 1appended to 16 CFR part 1501. The useand abuse testing provisions of 16 CFR1500.51 through 1500.53 and 1501.4(b)(2)do not apply to this definition.

(6) Package or packaging refers to theimmediate package in which a productsubject to labeling under section 24 ofthe act is sold, as well as to any outercontainer or wrapping for that pack-age.

(7) Descriptive material means any dis-crete piece of written material sepa-rate from the label of the package thatcontains an instruction (whether writ-ten or otherwise) for the use of a prod-uct subject to these labeling require-ments, any depiction of the product,and any written material that specifi-cally describes any function, use,warnings, user population, design ormaterial specification, or other char-acteristic of the product. A catalog orother marketing material or advertise-ment that depicts other products in ad-dition to the product it accompanies isnot ‘‘descriptive material’’ unless itcontains additional information, suchas instructions for use of the product itaccompanies or lists of accessories ex-clusively for use with that product,that are designed to focus the pur-chaser’s attention on the product. De-scriptive material ‘‘accompanies’’ aproduct subject to the labeling require-ments when it is packaged with theproduct or when it is intended to bedistributed with the product at thetime of sale or delivery to the pur-chaser. ‘‘Descriptive material’’ doesnot include statements that appear on


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the package of a product subject to thelabeling requirements. ‘‘Descriptivematerial’’ does not include material in-tended solely for use by children if thepackage it accompanies contains a sep-arate package insert prominently iden-tified as a warning for parents thatcontains the required precautionarystatements.

(8) Bin and container for retail displaymean containers in which multipleunpackaged and unlabeled items areheld for direct selection by and sale toconsumers.

(b) Misbranded toys and children’s arti-cles. Pursuant to sections 2(p) and 24 ofthe FHSA, the following articles aremisbranded hazardous substances iftheir packaging, any descriptive mate-rial that accompanies them, and, ifunpackaged and unlabeled, any bin inwhich they are held for sale, any con-tainer in which they are held for retail

display, or any vending machine fromwhich they are dispensed, fails to bearthe labeling statements required inparagraphs (b) (1) through (4) and para-graph (f)(3) of this section, or if suchlabeling statements fail to complywith the prominence and conspicuous-ness requirements of paragraph (d) ofthis section.

(1) With the exception of books andother articles made of paper, writingmaterials such as crayons, chalk, pen-cils, and pens, modeling clay and simi-lar products, fingerpaints, watercolors,and other paint sets, and any other ar-ticle identified in 16 CFR 1501.3 (otherthan balloons), any article that is a toyor game intended for use by childrenwho are at least three years old butless than six years of age shall bear orcontain the following cautionary state-ment if the toy or game includes asmall part:

(2) Any latex balloon, or toy or gamethat contains a latex balloon, shall

bear the following cautionary state-ment:

(3)(I) Any small ball intended forchildren three years of age or older

shall bear the following cautionarystatement:


401


(ii) Any toy or game intended forchildren who are at least three yearsold but less than eight years of age

that contains a small ball shall bearthe following cautionary statement:

(4)(i) Any marble intended for chil-dren three years of age or older shall

bear the following cautionary state-ment:

(ii) Any toy or game intended forchildren who are at least three yearsold but less than eight years of age

that contains a marble shall bear thefollowing cautionary statement:

(c) Age of intended user. In determin-ing the ages of the children for which

any toy or article subject to this sec-tion is intended, the following factors


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are relevant: the manufacturer’s statedintent (such as the age stated on alabel) if it is reasonable; the advertis-ing, marketing, and promotion of thearticle; and whether the article is com-monly recognized as being intended forchildren in this age group. In enforcingthis provision, the Commission will fol-low the procedures set forth in 16 CFR1501.5.

(d) Prominence and conspicuousness oflabeling statements. The requirements of16 CFR 1500.121 relating to the promi-nence and conspicuousness of pre-cautionary labeling statements for haz-ardous substances shall apply to anylabeling statement required under§ 1500.19(b) and (f), with the followingclarifications and modifications.

(1) All labeling statements requiredby § 1500.19(b) and (f) shall be in theEnglish language. The statements re-quired by paragraph (b) need not ap-pear in the format and layout depictedin paragraph (b). The statements re-quired by 16 CFR 1500.19(b) and (f) shallbe blocked together within a square orrectangular area, with or without aborder. This means that the state-ments must appear on at least twolines. The statements shall be sepa-rated from all other graphic materialby a space no smaller than the mini-mum allowable height of the type sizefor other cautionary material (e.g., thephrase ‘‘Not for children under 3 yrs.’’).If not separated by that distance, thelabeling statements must be sur-rounded by a border line. Label design,the use of vignettes, or the proximityof other labeling or lettering shall notobscure or render inconspicuous any la-beling statement required under§ 1500.19(b) and (f). This means thatsuch statements shall appear on a solidbackground, which need not differ fromthe background color or any othercolor on the package label.

(2) The words ‘‘WARNING’’ or‘‘SAFETY WARNING’’ required by sec-tion 24 of the FHSA shall be regardedas signal words.

(3) The statement ‘‘CHOKING HAZ-ARD’’ shall be regarded as a statementof the principal hazard associated withthe products subject to this section.

(4) All other remaining statementsrequired by this section shall be re-garded as ‘‘other cautionary material’’

as that term is defined in 16 CFR1500.121(a)(2)(viii).

(5) The principal display panel for abin, container for retail display, orvending machine shall be the side orsurface designed to be most promi-nently displayed, shown, or presentedto, or examined by, prospective pur-chasers. In the case of bins or contain-ers for retail display, the cautionarymaterial may be placed on a displaycard of a reasonable size in relationshipto the surface area of the bin or con-tainer. The area of the display cardshall constitute the area of the prin-cipal display panel. In the case of vend-ing machines that contain a displaycard, the cautionary label may beplaced either on the display card, onthe coinage indicator decal, or on theglass or clear plastic of the machine. Ifthere is no display card inside a vend-ing machine, the size of the principaldisplay panel will be calculated in ac-cordance with 16 CFR 1500.121(c) basedon the size of the front of the containerfrom which items are dispensed, exclu-sive of the area of metal attachments,coin inserts, bases, etc. Any other sideor surface of such a bin, container forretail sale, or vending machine thatbears information, such as price orproduct description, for examinationby purchasers shall be deemed to be aprincipal display panel, excluding anyside or surface with information thatonly identifies the company that ownsor operates a vending machine.

(6) All of the labeling statements re-quired by this section, including thoseclassified as ‘‘other cautionary mate-rial,’’ must appear on the principal dis-play panel of the product, except asprovided for by § 1500.19(f). Any signalword shall appear on the same line andin close proximity to the triangle re-quired by section 24 of the act. Mul-tiple messages should be provided withsufficient space between them, whenfeasible, to prevent them from visuallyblending together.

(7) All labeling statements requiredby this section shall comply with thefollowing type size requirements. 16CFR 1500.121(c)(1) explains how to com-pute the area of the principal displaypanel and letter height.


403


Area sq. in ......................................... 0–2 +2–5 +5–10 +10–15 +15–30 +30–100 +100–400 +400Type Size ........................................... ......... ......... ......... .......... .......... ............ ............. .......Sig. Wd .............................................. 3⁄64′′ 1⁄16′′ 3⁄32′′ 7⁄64′′ 1⁄8′′ 5⁄32′′ 1⁄4′′ 1⁄2′′St. Haz ............................................... 3⁄64′′ 3⁄64′′ 1⁄16′′ 3⁄32′′ 3⁄32′′ 7⁄64′′ 5⁄32′′ 1⁄4′′Oth. Mat ............................................ 1⁄32′′ 3⁄64′′ 1⁄16′′ 1⁄16′′ 5⁄64′′ 3⁄32′′ 7⁄64′′ 5⁄32′′

(8) Labeling required by this sectionthat appears on a bin, container for re-tail display, or vending machine shallbe in reasonable proximity to any pric-ing or product information containedon the principal display panel, or, ifsuch information is not present, inclose proximity to the article that issubject to the labeling requirements.

(9) Descriptive material that accom-panies a product subject to the labelingrequirements, including accompanyingmaterial subject to the alternative al-lowed by § 1500.19(f), shall comply withthe requirements of 16 CFR1500.121(c)(6) relating to literature con-taining instructions for use which ac-companies a hazardous substance. Ifthe descriptive material contains in-structions for use, the required pre-cautionary labeling shall be in reason-able proximity to such instructions ordirections and shall be placed togetherwithin the same general area (see 16CFR 1500.121(c)(6)).

(10) In the case of any alternative la-beling statement permitted under§ 1500.19(e), the requirements of 16 CFR1500.121(b)(3) and 1500.121(c)(2)(iii) shallapply to statements or indicators onthe principal display panel directingattention to the complete cautionarylabeling that appears on another dis-play panel.

(11) Any triangle required by this sec-tion shall be an equilateral triangle.The height of such a triangle shall beequal to or exceed the height of the let-ters of the signal word ‘‘WARNING’’.The height of the exclamation point in-side the triangle shall be at least halfthe height of the triangle, and the ex-clamation point shall be centered ver-tically in the triangle. The triangle

shall be separated from the signal wordby a distance at least equal to thespace occupied by the first letter of thesignal word. In all other respects, tri-angles with exclamation points shallconform generally to the provisions of16 CFR 1500.121 relating to signalwords.

(e) Combination of labeling statements.The labels of products that containmore than one item subject to the re-quirements of this section may com-bine information relating to each ofthe respective hazards, if the resultingcondensed statement contains all ofthe information necessary to describethe hazard presented by each article.However, in the case of a product thatcontains a balloon and another itemsubject to the labeling requirements,only the signal word and statement ofhazard may be combined.

(f) Alternative labeling statements forsmall packages. Any cautionary state-ment required by section 1500.19(b) maybe displayed on a display panel of thepackage of a product subject to the la-beling requirement other than theprincipal display panel only if:

(1) The package has a principal dis-play panel of 15 square inches or less,

(2) The full labeling statement re-quired by paragraph (b) of this sectionis displayed in three or more languageson another display panel of the pack-age of the product, and

(3)(i) In the case of a toy or gamesubject to § 1500.19(b)(1), a small ballsubject to § 1500.19(b)(3), a marble sub-ject to § 1500.19(b)(4), or a toy or gamecontaining such a ball or marble, theprincipal display panel of the packagebears the statement:


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and bears an arrow or other indicatorpointing toward or directing the pur-chaser’s attention to the display panelon the package where the full labelingstatement appears, or

(ii) In the case of a balloon subject to§ 1500.19(b)(2) or a toy or game contain-ing such a balloon, the principal dis-play panel bears the statement:

and bears an arrow or other indicatorpointing toward or directing the pur-chaser’s attention to the display panelon the package where the full labelingstatement appears.

(g) Alternative for products manufac-tured outside the United States. In thecase of a product subject to the label-ing requirements of § 1500.19(b) which ismanufactured outside the UnitedStates and is shipped directly from themanufacturer to the consumer by Unit-ed States mail or other delivery servicein an immediate package that containsdescriptive material, the descriptivematerial inside the immediate packageof the product need not bear the re-quired labeling statement only if theshipping container of the product con-tains other accompanying materialthat bears the required statements dis-played in a prominent and conspicuousmanner. Products shipped from abroadto a U.S. affiliate for shipment to con-sumers are included within the scope ofthis exception.

(h) Preemption. Section 101(e) of theChild Safety Protection Act of 1994 pro-hibits any state or political subdivisionof a state from enacting or enforcingany requirement relating to cautionarylabeling addressing small parts hazardsor choking hazards associated with anytoy, game, marble, small ball, or bal-loon intended or suitable for use bychildren unless the state or local re-quirement is identical to a require-ment established by section 24 of theFHSA or by 16 CFR 1500.19. Section101(e) allows a state or political sub-division of a state to enforce a non-identical requirement relating to cau-tionary labeling warning of small partshazards or choking hazards associatedwith any toy subject to the provisionsof section 24 of FHSA until January 1,

1995, if the non-identical requirementwas in effect on October 2, 1993.

[60 FR 10752, Feb. 27, 1995, as amended at 60FR 41802, Aug. 14, 1995]

§ 1500.40 Method of testing toxic sub-stances.

The method of testing the toxic sub-stances referred to in § 1500.3(c)(1)(ii)(C) and (2)(iii) is as follows:

(a) Acute dermal toxicity (single expo-sure). In the acute exposures, the agentis held in contact with the skin bymeans of a sleeve for periods varyingup to 24 hours. The sleeve, made of rub-ber dam or other impervious material,is so constructed that the ends are re-inforced with additional strips andshould fit snugly around the trunk ofthe animal. The ends of the sleeve aretucked, permitting the central portionto ‘‘balloon’’ and furnish a reservoir forthe dose. The reservoir must have suffi-cient capacity to contain the dosewithout pressure. In the followingtable are given the dimensions ofsleeves and the approximate body sur-face exposed to the test substance. Thesleeves may vary in size to accommo-date smaller or larger subjects. In thetesting of unctuous materials that ad-here readily to the skin, mesh wirescreen may be employed instead of thesleeve. The screen is padded and raisedapproximately 2 centimeters from theexposed skin. In the case of dry powderpreparations, the skin and substanceare moistened with physiological sa-line prior to exposure. The sleeve orscreen is then slipped over the gauzethat holds the dose applied to the skin.In the case of finely divided powders,the measured dose is evenly distributedon cotton gauze which is then securedto the area of exposure.


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Dimensions of Sleeves for Acute Dermal Toxicity Test[Test animal—Rabbits]

Measurements in centimeters Range of weight of ani-mals (grams)

Average area of exposure(square centimeters)

Average percentageof total body surfaceDiameter at ends Overall length

7.0 12.5 2,500–3,500 240 10.7

(b) Preparation of test animal. The ani-mals are prepared by clipping the skinof the trunk free of hair. Approxi-mately one-half of the animals are fur-ther prepared by making epidermalabrasions every 2 or 3 centimeters lon-gitudinally over the area of exposure.The abrasions are sufficiently deep topenetrate the stratum corneum (hornylayer of the epidermis) but not todistrub the derma; that is, not to ob-tain bleeding.

(c) Procedures for testing. The sleeve isslipped onto the animal which is thenplaced in a comfortable but immo-bilized position in a multiple animalholder. Selected doses of liquids and so-lutions are introduced under thesleeve. If there is slight leakage fromthe sleeve, which may occur during thefirst few hours of exposure, it is col-lected and reapplied. Dosage levels areadjusted in subsequent exposures (ifnecessary) to enable a calculation of adose that would be fatal to 50 percentof the animals. This can be determinedfrom mortality ratios obtained at var-ious doses employed. At the end of 24hours the sleeves or screens are re-moved, the volume of unabsorbed ma-terial (if any) is measured, and the skinreactions are noted. The subjects arecleaned by thorough wiping, observedfor gross symptoms of poisoning, andthen observed for 2 weeks.

§ 1500.41 Method of testing primary ir-ritant substances.

Primary irritation to the skin ismeasured by a patch-test technique onthe abraded and intact skin of the al-bino rabbit, clipped free of hair. A min-imum of six subjects are used in ab-raded and intact skin tests. Introduceunder a square patch, such as surgicalgauze measuring 1 inch by 1 inch andtwo single layers thick, 0.5 milliliter(in the case of liquids) or 0.5 gram (inthe case of solids and semisolids) of thetest substance. Dissolve solids in an ap-

propriate solvent and apply the solu-tion as for liquids. The animals are im-mobilized with patches secured in placeby adhesive tape. The entire trunk ofthe animal is then wrapped with an im-pervious material, such as rubberizedcloth, for the 24-hour period of expo-sure. This material aids in maintainingthe test patches in position and retardsthe evaporation of volatile substances.After 24 hours of exposure, the patchesare removed and the resulting reac-tions are evaluated on the basis of thedesignated values in the followingtable:

Skin reaction Value 1

Erythema and eschar formation:No erythema ................................................... 0Very slight erythema (barely perceptible) ...... 1Well-defined erythema ................................... 2Moderate to severe erythema ........................ 3Severe erythema (beet redness) to slight

eschar formations (injuries in depth) .......... 4Edema formation:

No edema ....................................................... 0Very slight edema (barely perceptible) .......... 1Slight edema (edges of area well defined by

definite raising) ........................................... 2Moderate edema (raised approximately 1

millimeter) ................................................... 3Severe edema (raised more than 1 millimeter

and extending beyond the area of expo-sure) ............................................................ 4

1 The ‘‘value’’ recorded for each reading is the averagevalue of the six or more animals subject to the test.

Readings are again made at the end ofa total of 72 hours (48 hours after thefirst reading). An equal number of ex-posures are made on areas of skin thathave been previously abraded. Theabrasions are minor incisions throughthe stratum corneum, but not suffi-ciently deep to disturb the derma or toproduce bleeding. Evaluate the reac-tions of the abraded skin at 24 hoursand 72 hours, as described in this para-graph. Add the values for erythema andeschar formation at 24 hours and at 72hours for intact skin to the values onabraded skin at 24 hours and at 72hours (four values). Similarly, add thevalues for edema formation at 24 hours


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16 CFR Ch. II (1–1–97 Edition)§ 1500.42

and at 72 hours for intact and abradedskin (four values). The total of theeight values is divided by four to givethe primary irritation score; for exam-ple:

Skin reactionExposure

time(hours)

Evalua-tion value

Erythema and eschar formation:Intact skin ................................... 24 2

Do ........................................... 72 1Abraded skin .............................. 24 3

Do ........................................... 72 2

Subtotal ............................ ................ 8

Edema formation:Intact skin ................................... 24 0

Do ........................................... 72 1Abraded skin .............................. 24 1

Do ........................................... 72 2

Subtotal ............................ ................ 4

Total ................................. ................ 12

Thus, the primary irritation score is12÷4=3.

§ 1500.42 Test for eye irritants.(a)(1) Six albino rabbits are used for

each test substance. Animal facilitiesfor such procedures shall be so designedand maintained as to exclude sawdust,wood chips, or other extraneous mate-rials that might produce eye irritation.Both eyes of each animal in the testgroup shall be examined before testing,and only those animals without eye de-fects or irritation shall be used. Theanimal is held firmly but gently untilquiet. The test material is placed inone eye of each animal by gently pull-ing the lower lid away from the eyeballto form a cup into which the test sub-stance is dropped. The lids are thengently held together for one second andthe animal is released. The other eye,remaining untreated, serves as a con-trol. For testing liquids, 0.1 milliliteris used. For solids or pastes, 100 milli-grams of the test substance is used, ex-cept that for substances in flake, gran-ule, powder, or other particulate formthe amount that has a volume of 0.1milliliter (after compacting as much aspossible without crushing or alteringthe individual particles, such as by tap-ping the measuring container) shall beused whenever this volume weighs lessthan 100 milligrams. In such a case, theweight of the 0.1 milliliter test dose

should be recorded. The eyes are notwashed following instillation of testmaterial except as noted below.

(2) The eyes are examined and thegrade of ocular reaction is recorded at24, 48, and 72 hours. Reading of reac-tions is facilitated by use of a bin-ocular loupe, hand slit-lamp, or otherexpert means. After the recording ofobservations at 24 hours, any or alleyes may be further examined after ap-plying fluorescein. For this optionaltest, one drop of fluorescein sodiumophthalmic solution U.S.P. or equiva-lent is dropped directly on the cornea.After flushing out the excess fluores-cein with sodium chloride solutionU.S.P. or equivalent, injured areas ofthe cornea appear yellow; this is bestvisualized in a darkened room under ul-traviolet illumination. Any or all eyesmay be washed with sodium chloridesolution U.S.P. or equivalent after the24-hour reading.

(b)(1) An animal shall be consideredas exhibiting a positive reaction if thetest substance produces at any of thereadings ulceration of the cornea(other than a fine stippling), or opacityof the cornea (other than a slightdulling of the normal luster), or in-flammation of the iris (other than aslight deepening of the folds (or rugae)or a slight circumcorneal injection ofthe blood vessels), or if such substanceproduces in the conjunctivae (exclud-ing the cornea and iris) an obviousswelling with partial eversion of thelids or a diffuse crimson-red with indi-vidual vessels not easily discernible.

(2) The test shall be considered posi-tive if four or more of the animals inthe test group exhibit a positive reac-tion. If only one animal exhibits a posi-tive reaction, the test shall be regardedas negative. If two or three animals apositive reaction, the test is repeatedusing a different group of six animals.The second test shall be consideredpositive if three or more of the animalsexhibit a positive reaction. If only oneor two animals in the second test ex-hibit a positive reaction, the test shallbe repeated with a different group ofsix animals. Should a third test beneeded, the substance will be regardedas an irritant if any animal exhibits apositive response.


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1 The Illustrated Guide is out of print and,as of January 1, 1981, no longer available.However, information about the test method,and black and white photocopies may be ob-tained by writing to the Directorate forHealth Sciences, CPSC, Washington, D.C.20207, (301) 492–6957.

(c) To assist testing laboratories andother interested persons in interpret-ing the results obtained when a sub-stance is tested in accordance with themethod described in paragraph (a) ofthis section, an ‘‘Illustrated Guide forGrading Eye Irritation by HazardousSubstances’’ will be sold by the Super-intendent of Documents, U.S. Govern-ment Printing Office, Washington, D.C.20402. 1 The guide will contain colorplates depicting responses of varyingintensity to specific test solutions. Thegrade of response and the substanceused to produce the response will be in-dicated.

[38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov.1, 1973]

§ 1500.43 Method of test for flashpointof volatile flammable materials byTagliabue open-cup apparatus.

SCOPE

1. (a) This method describes a test proce-dure for the determination of open-cupflashpoints of volatile flammable materialshaving flashpoints below 175 °F.

(b) This method, when applied to paintsand resin solutions which tend to skin overor which are very viscous, gives less repro-ducible results than when applied to sol-vents.OUTLINE OF METHOD

2. The sample is placed in the cup of a TagOpen Tester, and heated at a slow but con-stant rate. A small test flame is passed at auniform rate across the cup at specified in-tervals. The flashpoint is taken as the lowesttemperature at which application of the testflame causes the vapor at the surface of theliquid to flash, that is, ignite but not con-tinue to burn.APPARATUS

3. The Tag open-cup tester is illustrated inFig. 1. It consists of the following parts,which must conform to the dimensionsshown, and have the additional characteris-tics as noted:

(a) Copper bath, preferably equipped with aconstant level overflow so placed as to main-tain the bath liquid level 1⁄8-inch below therim of the glass cup.

(b) Thermometer holder. Support firmly withringstand and clamp.

(c) Thermometer. For flashpoints above 40°F., use the ASTM Tag Closed Tester Ther-mometer, range of +20 to +230 °F., in 1 °F. di-visions, and conforming to thermometer 9F.of ASTM Standard E 1. For flashpoints from20 °F. to 40 °F., use ASTM Tag Closed Tester,Low Range, Thermometer 57F. Forflashpoints below 20 °F., use ASTM Ther-mometer 33F. The original Tag Open-Cup(Paper Scale) Thermometer will be a permis-sible alternate until January 1, 1962. It iscalibrated to ¥20 °F.

(d) Glass test cup. Glass test cup (Fig. 2), ofmolded clear glass, annealed, heat-resistant,and free from surface defects.


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16 CFR Ch. II (1–1–97 Edition)§ 1500.43

(e) Leveling device. Leveling device orguide, for proper adjustment of the liquidlevel in the cup (Fig. 3). This shall be madeof No. 18-gage polished aluminum, with aprojection for adjusting the liquid level whenthe sample is added to exactly 1⁄8-inch belowthe level of the edge or rim of the cup.

(f) ‘‘Micro,’’ or small gas burner of suitabledimensions for heating the bath. A screwclamp may be used to help regulate the gas.A small electric heater may be used.

(g) Ignition taper, which is a smallstraight, blow-pipe type gas burner. The testflame torch prescribed in the method of testfor flash and fire points by Cleveland OpenCup (ASTM designation: D 92) is satisfac-tory.

(h) Alternative methods for maintainingthe ignition taper in a fixed horizontal planeabove the liquid may be used, as follows:

(1) Guide wire, 3⁄32-inch in diameter and 31⁄2inches in length, with a right-angle bend 1⁄2-inch from each end. This wire is placed snug-ly in holes drilled in the rim of the bath, sothat the guide wire is 5⁄8-inch from the centerof the cup and resting on the rim of the cup.

(2) Swivel-type taper holder, such as isused in ASTM METHOD D 92. The height andposition of the taper are fixed by adjusting

the holder on a suitable ringstand supportadjacent to the flash cup.

(i) Draft shield, consisting of two rectangu-lar sheets of noncombustible material, 24inches × 28 inches, are fastened togetheralong the 28-inch side, preferably by hinges.A triangular sheet, 24 inches × 24 inches × 34inches is fastened by hinges to one of the lat-eral sheets (to form a top when shield isopen). The interior of the draft shield shallbe painted a flat black.PROCEDURE

4. (a) Place the tester on a solid table freeof vibration, in a location free of perceptibledraft, and in a dim light.

(b) Run water, brine, or water-glycol solu-tion into the bath to a predetermined level,which will fill the bath to 1⁄8-inch below thetop when the cup is in place. An overflow ispermissible for water-level control.

(c) Firmly support the thermometer verti-cally halfway between the center and edge ofthe cup on a diameter at right angles to theguide wire, or on a diameter passing throughthe center of the cup and the pivot of thetaper. Place so that the bottom of the bulbis 1⁄4-inch from the inner bottom surface ofthe cup. If the old Tagliabue thermometer isused, immerse to well cover the mercurybulb, but not the wide body of the thermom-eter.

(d) Fill the glass cup with the sample liq-uid to a depth just 1⁄8-inch below the edge, asdetermined by the leveling device.

(e) Place the guide wire or swivel device inposition, and set the draft shield around thetester so that the sides from right angleswith each other and the tester is well towardthe back of the shield.

(f) If a guide wire is used, the taper, whenpassed, should rest lightly on the wire, withthe end of the jet burner just clear of theedge of the guide wire. If the swivel-typeholder is used, the horizontal and verticalpositions to the jet are so adjusted that thejet passes on the circumference of a circle,having a radius of at least 6 inches, acrossthe center of the cup at right angles to thediameter passing through the thermometer,and in a plane 1⁄8-inch above the upper edgeof the cup. The taper should be kept in the‘‘off’’ position, at one end or the other of theswing, except when the flame is applied.

(g) Light the ignition flame and adjust itto form a flame of spherical form matchingin size the 5⁄52-inch sphere on the apparatus.

(h) Adjust heater source under bath so thatthe temperature of the sample increases at arate of 2±0.5 °F. per minute. With viscous ma-terials this rate of heating cannot always beobtained.INITIAL TEST

5. Determine an approximate flashpoint bypassing the taper flame across the sample atintervals of 2 °F. Each pass must be in onedirection only. The time required to pass the


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Consumer Product Safety Commission § 1500.43a

1 Setaflash is a registered trademark ofStanhope-Seta Limited, Surrey, England.

ignition flame across the surface of the sam-ple should be 1 second. Remove bubbles fromthe surface of the sample liquid before start-ing a determination. Meticulous attention toall details relating to the taper, size of taperflame, and rate of passing the taper is nec-essary for good results. When determiningthe flashpoint of viscous liquids and thoseliquids that tend to form a film of polymer,etc., on the surface, the surface film shouldbe disturbed mechanically each time beforethe taper flame is passed.RECORDED TESTS

6. Repeat the procedure by cooling a freshportion of the sample, the glass cup, the bathsolution, and the thermometer at least 20 °F.below the approximate flashpoint. Resumeheating, and pass the taper flame across thesample at two intervals of 2 °F. until theflashpoint occurs.REPORTING DATA

7. The average of not less than three re-corded tests, other than the initial test,shall be used in determining the flashpointand flammability of the substance.STANDARDIZATION

8. (a) Make determinations in triplicate onthe flashpoint of standard paraxylene and ofstandard isopropyl alcohol which meet thefollowing specifications:

(i) Specifications for p-xylene, flashpointcheck grade. p-xylene shall conform to the fol-lowing requirements;

Specific gravity: 15.56 °C./15.56 °C., 0.860 mini-mum, 0.866 maximum

Boiling range: 2 °C. maximum from start todry point when tested in accordance withthe method of test for distillation of indus-trial aromatic hydrocarbons (ASTM des-ignation: D 850), or the method of test fordistillation range of lacquer solvents anddiluents (ASTM) designation D 1078). Therange shall include the boilng point of pureP-xylene, which is 138.35 °C. (281.03 °F.).

Purity: 95 percent minimum, calculated inaccordance with the method of test for de-termination of purity from freezing pointsof high-purity compounds (ASTM designa-tion: D 1016), from the experimentally de-termined freezing point, measured by themethod of test for measurement of freezingpoints of high-purity compounds for eval-uation of purity (ASTM designation: D1015).

(ii) Specifications for ispropanol, flash pointcheck grade. Isopropanol shall conform to thefollowing requirements:

Specific gravity: 0.8175 to 0.8185 at 20 °C./20°C. as determined by means of a calibratedpycnometer.

Distillation range: Shall entirely distillwithin a 1.0 °C. range which shall include

the temperature 80.4 °C. as determined byASTM method D 1078.

Average these values for each compound. Ifthe difference between the values for thesetwo compounds is less than 15 °F. (8.5 °C.) ormore than 27 °F. (16 °C.), repeat the deter-minations or obtain fresh standards.

(b) Calculate a correction factor as follows:

X=92–AY=71–B

Correction=(X+Y)/2.

Where:A=Observed flash of p-xylene, andB=Observed flash of isopropyl alcohol.

Apply this correction of all determinations.Half units in correction shall be discarded.PRECISION

9. (a) For hydrocarbon solvents havingflashpoints between 60 °F. and 110 °F.,repeatability is ±2 °F. and the reproducibilityis ±5 °F.

(b) If results from two tests differ by morethan 10 °F., they shall be considered uncer-tain and should be checked. This calibrationprocedure provided in this method will can-cel out the effect of barometric pressure ifcalibration and tests are run at the samepressure. Data supporting the precision aregiven appendix III of the 1956 Report of Com-mittee D–1 on Paint, Varnish, Lacquers andRelated Products, Proceedings, Am. Soc.Testing Mats., Vol. 56 (1956).

NOTE: The test apparatus and procedure de-scribed in § 1500.43 may be used by manufac-turers and labelers of products subject to theFederal Hazardous Substances Act to deter-mine flashpoint temperatures of those prod-ucts under the conditions set forth in§ 1500.3(c)(6)(iv), as amended.

[51 FR 28537, Aug. 8, 1986]

§ 1500.43a Method of test for flashpointof volatile flammable materials.

(a) Scope. (1) This method describesthe test procedure which the Commis-sion will use for the determination ofthe flashpoint of volatile flammablematerials, using a Setaflash 1 low-rangeclosed tester, or an apparatus produc-ing equivalent results. The method de-scribed in this section is essentially aSetaflash equilibrium procedure whichclosely parallels the test method des-ignated ASTM D 3828-81, ‘‘StandardTest Methods for Flash Point bySetaflash Closed Tester,’’ published bythe American Society for Testing andMaterials (ASTM), 1916 Race Street,


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16 CFR Ch. II (1–1–97 Edition)§ 1500.43a

Philadelphia, Pennsylvania 19103. Man-ufacturers and labelers of products sub-ject to labeling and other requirementsunder the Federal Hazardous Sub-stances Act may use other apparatusand/or test methods which produceequivalent results.

(2) At the option of the user, the pro-cedures described in this section maybe used to determine the actualflashpoint temperature of a sample orto determine whether a product will orwill not flash at a specified tempera-ture (flash/no flash).

(3) If the substance to be tested has aviscosity greater than 150 Stokes at 77°F (25 °C), see paragraph (n) of this sec-tion for modifications to the testingprocedure.

(4) If the Commission has reason tobelieve on the basis of reliable experi-ence or other relevant information ordata that the flammability hazard of asubstance is greater or less than itsflammability classification based onflashpoint temperature determined inaccordance with this § 1500.43a and thatthe substance should be reclassified,the Commission will initiate a rule-making proceeding for reclassificationof the substance. Product manufactur-ers and labelers may use reliable expe-rience or other relevant information ordata in addition to the flashpoint tem-perature of a substance as a basis forcompliance with any applicable re-quirements of the Federal HazardousSubstances Act in the absence of a ruleissued by the Commission to reclassifythe substance.

(b) Summary of test methods. (1) Meth-od A—Flash/No Flash Test. A specifiedvolume of sample is introduced by a sy-ringe into the cup of the apparatusthat is set and maintained at the speci-fied temperature. After a specific timea test flame is applied and an observa-tion made as to whether or not a flashoccurred. Test procedures are set forthin detail in § 1500.43a(i).

(2) Method B—Finite (or Actual)Flashpoint. (i) A specified voume ofsample is introduced into the cup ofthe apparatus that is maintained atthe expected flashpoint. After a speci-fied time a test flame is applied andthe observation made whether or not aflash occurred.

(ii) The specimen is removed fromthe cup, the cup cleaned, and the cuptemperature adjusted 5 °C (9 °F), loweror higher depending on whether or nota flash occurred previously. A freshspecimen is introduced and tested. Thisprocedure is repeated until theflashpoint is established within 5 °C (9°F).

(iii) The procedure is then repeatedat 1 °C (2 °F) intervals until theflashpoint is determined to the nearest1 °C (2 °F).

(iv) If improved accuracy is desiredthe procedure is repeated at 0.5 °C (1°F). Test procedures are set forth in de-tail at § 1500.43a(j).

(3) The test procedures will be modi-fied, where necessary, to ensure thatthe results obtained reflect the hazardof the substance under reasonably fore-seeable conditions of use. Thus, for ex-ample, the material, if a mixture, willnormally be tested as it comes fromthe container, and/or after a period ofevaporation. The period of evaporationfor a material which is a mixture willnormally be the time required for themixture to evaporate in an open beakerunder ambient conditions to 90 percentof its original volume, or a period offour hours, whichever occurs first.However, this period of evaporationwill be changed if the results obtaineddo not represent the hazard of the sub-stance under reasonably foreseeableconditions of use.

(c) Definition of flashpoint. The lowesttemperature of the sample, correctedto a barometric pressure of 101.3 kPa(760 mm Hg), at which application of atest flame causes the vapor of the sam-ple to ignite under specified conditionsof test. The sample is deemed to haveflashed when a large flame appears andinstantaneously propagates itself overthe surface of the sample. Occasion-ally, particularly near actualflashpoint, the application of the testflame will cause a halo or an enlargedflame; this is not a flash and should beignored.

(d) Test apparatus. The test apparatusis an equilibrium closed-cup testerwith a range up to 100 °C (212 °F). Theessential dimensions and requirementsare shown in figure 1 and table 3, andare described in § 1500.43a(m). Closed-cup flashpoint testers and accessories


411


2 If the instrument has two temperaturecontrol knobs, set the fine control (center,small knob) at its mid-position and allow itto remain there throughout the calibration.The calibration is determined by adjustingthe coarse control (large, outer knob) only.

3 When using the tester, it will be foundthat the indicator light may not illuminateand the temperature may not rise until atemperature control dial setting between oneand two is reached.

4 The barometric pressure used in this cal-culation must be the ambient pressure forthe laboratory at the time of test. Many an-eroid barometers, such as those used atweather stations and airports, are

Continued

meeting these requirements are avail-able from commercial suppliers anddistributors of laboratory equipment.

(e) Safety precautions. The operatormust exercise and take appropriatesafety precautions during the initialapplication of the test flame to thesample. Samples containing low-flashmaterial may give an abnormallystrong flash when the test flame is firstapplied.

(f) Preparation of samples. (1) Erro-neously high flashpoints may be ob-tained if precautions are not taken toavoid the loss of volatile material. Inpreliminary tests of materials takendirectly from the container, do notopen containers unnecessarily andmake a transfer unless the sample tem-perature is at least 10 °C (18 °F) belowthe expected flashpoint. Do not usesamples in leaky containers for thistest.

(2) Do not store samples in plastic(polyethylene, polypropylene, etc.) bot-tles since volatile material may diffusethrough the walls of the bottle.

(3) A 2-ml specimen is required foreach test. If possible, obtain at least a50-ml sample from the bulk test siteand store in a clean, tightly closed con-tainer.

(g) Preparation of apparatus. (1) Placethe tester on a level, stable surface.Unless tests are made in a draft-freearea, surround the tester on three sideswith a shield for protection. Do notrely on tests made in a laboratorydraft hood or near ventilators.

(2) Read the manufacturer’s instruc-tions on the care and servicing of theinstrument and for correct operation ofits controls.

(h) Calibration and standardization. (1)Before initial use determine and plotthe relationship between the tempera-ture control dial and the thermometerreadings at each major (numbered) dialdivision as follows:

Turn the temperature control knob 2

fully counterclockwise (‘‘O’’ reading).Advance the temperature control knobclockwise until the indicator light is

illuminated.3 Advance the knob clock-wise to the next numbered line. Afterthe thermometer mercury columnceases to advance, record the dial read-ing and the temperature. Advance theknob clockwise to the next numberedline. After the thermometer mercurycolumn ceases to advance, read the dialreading and the temperature. Repeatthis procedure through the full rangeof the instrument. Plot the dial read-ings versus the respective tempera-tures.

(2) Standardize the instrument usinga sample of material meeting the speci-fications in table 1. If the average oftwo determinations falls within the ac-ceptable limits the instrument is as-sumed to be operating properly. If theaverage of the two determinations doesnot fall within this range, check themanufacturer’s operating and mainte-nance instructions and determine thatthey are being followed. In particular,be sure that the cup lid assemblymakes a vapor-tight seal with the cup,the shutter provides a light-tight seal,and that adequate heat transfer pastesurrounds the thermometer bulb andthe immersed portion of the barrel.

(i) Test Method A—for determiningFlash/No Flash.

(1) Determine the target flashpointas follows:

(i) Target flashpoint, °C=Sc—0.25(101.3—A)

(ii) Target flashpoint, °C=Sc—0.03(760–B)

(iii) Target flashpoint, °F=Sf—0.06(760–B)

where:

Sc=specification, or uncorrected target,flashpoint, °C,

Sf=specification, or uncorrected target,flashpoint, °F,

B=ambient barometric pressure, mmHg,4 and


412


precorrected to give sea-level readings; thesemust not be used.

5 If the target or specification temperatureis not less than 5 °C (40 °F) crushed ice andwater may be used as charging (cooling)fluid. If below 5 °C (40 °F), a suitable charg-ing (cooling) fluid is solid carbon dioxide(dry ice) and acetone. If the refrigerantcharged cooling module is unavailable, referto the manufacturer’s instruction manualfor alternative methods of cooling.

6 The target temperature may be attainedby originally turning the coarse temperaturecontrol knob to the proper setting (see§ 1500.43a(h)(1) for the temperature desiredrather than the maximum setting (full on).The elapsed time to reach the temperaturewill be greater, except for maximum tem-perature. However, less attention will be re-quired during the intervening period.

7 For target or expected temperaturesbelow ambient, both syringe and samplemust be precooled to cup temperature (see§ 1500.43a(i)(3)(i)) before the specimen istaken.

8 For target temperatures below ambient,do not set the timer. Adjust the test flameand allow the temperature to rise under am-bient conditions until the target tempera-ture is reached. Immediately apply the testflame as detailed.

9 Never apply the test flame to the speci-men more than once. Fresh portions of thesample must be used for each test.

A=ambient barometer pressure, kPa.4

(2) Inspect the inside of the samplecup, lid, and shutter mechanism forcleaniness and freedom from contami-nation. Use an absorbent paper tissueto wipe clean, if necessary. Put coverin place and lock securely. The filingorifice may be convenienty cleanedwith a pipe cleaner.

(3) Set the instrument at the targettemperature.

(i) For target temperature below am-bient. The instrument power switch isto be in the off position. Fill therefigerant-charged cooling block with asuitable material.5 Raise the lid andshutter assembly, and position the baseof the block in the sample cup, beingcareful not to injure or mar the cup.When the thermometer reads approxi-mately 6 to 10 °C (10 to 20 °F) below thetarget temperature, remove the coolingblock and quickly dry the cup with apaper tissue to remove any moisture.Immediately close the lid and shutterassembly and secure. Prepare to intro-duce the sample using the syringe,both of which have been precooled to atemperature 5 to 10 °C (10 to 20 °F)below the target temperature.

(A) Caution: Do not cool the sampleblock below —38 °C, the freezing pointof mercury.

(B) Caution: Acetone is extremelyflammable. Keep away from heat,sparks, and flames and keep containerclosed when not actually pouring ace-tone. Use only in a well-ventilatedarea. Avoid inhalation and contactwith the eyes or skin. Use cloth orleather gloves, goggles or safety shield,and keep dry ice in a canvas bag, espe-cially when cracking.

(ii) For target temperature aboveambient. Switch the instrument on andturn the coarse temperature controlknob fully clockwise (full on) causing

the indicator light to illuminate.6When the thermometer indicates atemperature about 3 °C (5 °F) below thetarget (or specification) temperature,reduce the heat input to the samplecup by turning the coarse temperaturecontrol knob counter-clockwise to thedesired control point (see§ 1500.43a(i)(1)). When the indicatorlight slowly cycles on and off read thetemperature on the thermometer. Ifnecessary, adjust the fine (center) tem-perature control knob to obtain the de-sired test (target) temperature. Whenthe test temperature is reached and theindicator lamp slowly cycles on andoff, prepare to introduce the sample.

(4) Charge the syringe with a 2-mlspecimen of the sample 7 to be tested;transfer the syringe to the filling ori-fice, taking care not to lose any sam-ple; discharge the test specimen intothe cup by fully depressing the syringeplunger, remove the syringe.

(5)(i) Set the timer 8 by rotating itsknob clockwise to its stop. Open thegas control valve and light the pilotand test flames. Adjust the test flamewith the pinch valve to conform to thesize of the 4-mm (5/32-in.) gage.

(ii) After the time signal indicatesthe specimen is at test temperature 8,apply the test flame by slowly and uni-formly opening the shutter and closingit completely over a period of approxi-mately 21⁄2 s.9 Watch closely for a flashat the cup openings.


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10 For expected flashpoint below ambient,do not set the timing device. Adjust the testflame. Allow the temperature to rise underambient conditions until the temperaturereaches 5 °C (9 °F) below the expectedflashpoint. Immediately apply the testflame.

(iii) The sample is deemed to haveflashed when a large flame appears andinstantaneously propagates itself overthe surface of the sample (see§ 1500.43a(c)).

(6) Record the test results as ‘‘flash’’or ‘‘no flash’’ and the test temperature.

(7) Turn off the pilot and test flamesusing the gas control valve. Removethe sample and clean the instrument.It may be necessary to allow the cuptemperature to decline to a safe levelbefore cleaning.

(j) Test Method B—for determining Fi-nite or Actual Flashpoint. (1) Inspect theinside of the sample cup, lid, and shut-ter mechanism for cleanliness and free-dom from contamination. Use an ab-sorbent paper tissue to wipe clean, ifnecessary. Put cover in place and locksecurely. The filling orifice may beconveniently cleaned with a pipe clean-er.

(2) For expected flashpoints belowambient. (i) The instrument powerswitch is to be in off position. Fill therefrigerant-charged cooling block witha suitable material.5 Raise the lid andshutter assembly, and position the baseof the block in the sample cup, beingcareful not to injure or mar the cup.When the thermometer reaches a tem-perature 5 to 10 °C (10 to 20 °F) belowthe expected flashpoint, remove thecooling block and quickly dry the cupwith a paper tissue to remove anymoisture. Immediately close the lidand shutter assembly and secure. Pre-pare to introduce the sample using thesyringe, both of which have beenprecooled to a temperature 5 to 10 °C(10 to 20 °F) below the expected tem-perature (See § 1500.43a(j)(5)).

(ii) Caution: Do not cool the sampleblock below ¥38 °C, the freezing pointof mercury.

(3) For tests where the expectedflashpoint is above ambient. Turn thecoarse temperature control knob fullyclockwise (full on) causing the indica-tor light to illuminate. When the ther-mometer reaches a temperature 3 °C (5°F) below the estimated flashpoint,turn the coarse temperature knobcounter-clockwise to the dial readingrepresenting the estimated flashpointtemperature as shown on the calibra-tion curve (See § 1500.43a(h)(1)). Whenthe indicator light slowly cycles on and

off, read the temperature on the ther-mometer. If necessary, adjust the finetemperature control knob to obtain theexact desired temperature.

(4)(i) Charge the syringe 7 with a 2 mlspecimen of the sample 7 to be tested;transfer the syringe to the filling ori-fice, taking care not to lose any sam-ple; discharge the test specimen intothe cup by fully depressing the syringeplunger; remove the syringe.

(ii) Set the timer 10 by rotating itsknob clockwise to its stop. Open thegas control valve and ignite the pilotand test flames. Adjust the test flamewith the pinch valve to conform to thesize of the 4-mm (5⁄32-in.) gage.

(iii) After the audible time signal in-dicates the specimen is at test tem-perature,10 apply the test flame byslowly and uniformly opening the shut-ter and then closing it completely overa period of approximately 21⁄2 s. Watchclosely for a flash at the cup opening.

(iv) The sample is deemed to haveflashed only if a large flame appearsand instantaneously propagates itselfover the surface of the sample. (See§ 1500.43a(c).)

(v) Turn off the pilot and test flamesusing the gas control valve. When thecup temperature declines to a safelevel, remove the sample and clean theinstrument.

(5)(i) If a flash was observed in§ 1500.43a(j)(4)(iii) repeat the proceduregiven in § 1500.43a(j)(2) or (3), and in§ 1500.43a(j)(4), testing a new specimenat a temperature 5 °C (9 °F) below thatat which the flash was observed.

(ii) If necessary, repeat the procedurein § 1500.43a(j)(5)(i), lowering the tem-perature 5 °C (9 °F) each time, until noflash is observed.9

(iii) Proceed to § 1500.43a(j)(7).(6)(i) If no flash was observed in

§ 1500.43a(j)(4)(iii) repeat the proceduregiven in § 1500.43a(j)(2) or (3), and in§ 1500.43a(j)(4), testing a fresh specimenat a temperature 5 °C (9 °F) above thatat which the specimen was tested in§ 1500.43a(j)(4)(iii).


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(ii) If necessary repeat the procedurein § 1500.43a(j)(6)(i), above, raising thetemperature 5 °C (9 °F) each time untila flash is observed.9

(7) Having established a flash withintwo temperatures 5 °C (9 °F) apart, re-peat the procedure at 1 °C (2 °F) inter-vals from the lower of the two tem-peratures until a flash is observed.9Record the temperature of the testwhen this flash occurs as theflashpoint, allowing for any knownthermometer correction. Record thebarometric pressure.4

(8) The flashpoint determined in§ 1500.43a(j)(7) will be to the nearest 1 °C(2 °F). If improved accuracy is desired(that is, to the nearest 0.5 °C (1 °F)),test a fresh specimen at a temperature0.5 °C (1 °F) below that at which theflash was observed in § 1500.43a(j)(7). Ifno flash is observed, the temperaturerecorded in § 1500.43a(j)(7), is theflashpoint to the nearest 0.5 °C (1 °F). Ifa flash is observed at the lower tem-perature, record this latter tempera-ture as the flashpoint.

(9) Turn off the pilot and test flamesusing the gas control valve. When thecup temperature declines to a safelevel, remove the sample and clean theinstrument.

(k) Calculations. If it is desired to cor-rect the observed finite flashpoint forthe effect of barometric pressure, pro-ceed as follows: Observe and record theambient barometric pressure4 at thetime of the test. If the pressure differsfrom 101.3 kPa (760 mm Hg), correct theflashpoint as follows:

(1) Corrected flashpoint ( °C)=C+0.25(101.3–A)

(2) Corrected flashpoint ( °F)=F+0.06(760–B)

(3) Corrected flashpoint ( °C)=C+0.03(760–B)Where: F=Observed flashpoint, °F,C=observed flashpoint, °C,B=ambient barometric pressure, mm

Hg; andA=ambient barometric pressure, kPa.

(l) Precision. The precision of themethod as determined by statisticalexamination of interlaboratory resultsis as follows:

(1) Repeatability. The difference be-tween two test results obtained by thesame operator with the same apparatusunder constant operating conditions on

identical test material, would, in thelong run, in the normal and correct op-eration of the test method, exceed thevalues shown in table 2 only in 1 casein 20.

(2) Reproducibility. The differencebetween two single and independent re-sults obtained by different operatorsworking in different laboratories onidentical test material, would, in thelong run, in the normal and correct op-eration of the test method, exceed thevalues shown in table 2 only in 1 casein 20.

(m) Flash Test Apparatus. (1)(i) Unitconsisting of an aluminum alloy ornonrusting metal block of suitable con-ductivity with a cylindrical depression,or sample cup, over which is fitted acover. A thermometer is embedded inthe block.

(ii) The cover is fitted with an open-ing slide and a device capable of insert-ing an ignition flame (diameter 4±0.5mm) into the well when the slide de-vice shall intersect the plane of the un-derside of the cover. The cover is alsoprovided with an orifice extending intothe sample well for insertion of thetest sample and also a suitable clamp-ing device for securing the cover tight-ly to the metal block. The three open-ings in the cover shall be within the di-ameter of the sample well. When theslide is in the open position, the twoopenings in the slide shall coincide ex-actly with the two corresponding open-ings in the cover.

(iii) Electrical heaters are attachedto the bottom of the cup in a mannerthat provides efficient transfer of heat.An electronic heat control is requiredto hold the equilibrium temperature, ina draft-free area, within 0.1 °C (0.2 °F)for the low-temperature tester. A vis-ual indicator lamp shows when energyis or is not being applied. Energy maybe supplied from 120 or 240 V, 50 or 60Hz main service.

(2)(i) Test flame and pilot flame-regulatable test flame, for dipping intothe sample cup to try for flash, and apilot flame, to maintain the test flame,are required. These flames may befueled by piped gas service. A gage ring4mm (5/32 in.) in diameter, engraved onthe lid near the test flame, is requiredto ensure uniformity in the size of thetest flame.


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(ii) Caution: Never recharge the self-contained gas tank at elevated tem-perature, or with the pilot or testflames lighted, nor in the vicinity ofother flames.

(iii) Audible Signal is required. Theaudiable signal is given after 1 min inthe case of the low-temperature tester.

(iv) Syringe. 2ml capacity, equippedwith a needle suitable for use with theapparatus, adjusted to deliver 2.00± 0.05ml.

(3) Essential dimensions of the testapparatus are set forth in table 3.

(n) Testing high-viscosity liquids. (1)High-viscosity materials may be addedto the cup by the following procedure:

(i) Back load a 5 or 10-ml syringewith the sample to be tested and ex-trude 2 ml into the cup. Spread thespecimen as evenly as possible over thebottom of the cup.

(ii) If the sample cannot be loadedinto a syringe and extruded, othermeans of adding the sample to the cupmay be used such as a spoon. Add ap-proximately 2 ml of material to thespoon and then push the material fromthe spoon into the cup.

(iii) If the test specimen does notclose the sampling port in the cup, sealthe cup externally by suitable means.

(2) Using the appropriate procedure,either Method A in § 1500.43a(i) orMethod B in § 1500.43a(j), determine theflashpoint of the specimen which hasbeen added to the tester in accordancewith § 1500.43a(n)(i), except that thetime specified is increased from 1 to 5minutes for samples at or above ambi-ent temperature.

TABLE 1—CALIBRATION OF TESTERMaterial .................................. p-xyleneA (Caution).BSpecific gravity. 15.6/15.6 °C

(60/60 °F).0.850 to 0.866.

Boiling range ......................... 2 °C maximum including138.35 °C (281.03 °F).

Freezing point ........................ 11.23 °C (52.2 °F) minimum.Flashpoint °C (acceptable

range).25.6± 0.5 (78± 1 •Φ).

A Available as Flash Point Check Fluid (p-xylene) from Spe-cial Products Div., Phillips Petroleum Co., Drawer ‘O,’ Borger,Texas 79007.

B Caution: Handle xylene with care. Avoid inhalation; useonly in a well-ventilated area. Avoid prolonged or repeatedcontact with skin. Keep away from flames and heat, except asnecessary for the actual flash point determination.

TABLE 2—REPEATABILITY AND REPRODUCIBILITY

Temperature, °C ( °F) Repeatability,°C ( °F)

Reproducibility,°C ( °F)

20(68) ................................ 0.5(0.9) 1.4(2.6)70(158) .............................. 0.5(0.9) 2.9(5.3)93(200) .............................. 1.3(2.3) 4.9(8.8)150(300) ............................ 2.0(3.6) 7.5(13.5)200(400) ............................ 2.6(4.7) 9.9(17.9)260(500) ............................ 3.3(5.9) 12.4(22.3)

TABLE 3—ESSENTIAL DIMENSIONS OF FLASHTEST APPARATUS A, B

Sample Block

Block diameter ................................................. 61.5–62.5Sample well diameter ...................................... 49.40–49.70Sample well depth ........................................... 9.70–10.00Top of block to center of thermometer hole .... 16.00–17.00Diameter of thermometer hole (approx.) ......... 7.00

Cover

Large opening length ....................................... 12.42–12.47Large opening width ........................................ 10.13–10.18Small opening length ....................................... 5.05–5.10Small opening width ........................................ 7.60–7.65Distance between extreme edges of small

openings ....................................................... 48.37–48.32Filling orifice diameter ...................................... 4.00–4.50Bore or filler tube ............................................. 1.80–1.85Maximum distance of filler tube from base of

well with cover closed (max.) ....................... 0.75

Slide

Large opening length ....................................... 12.42–12.47Large opening width ........................................ 10.13–10.18Small opening length ....................................... 5.05–5.10Small opening width ........................................ 7.60–7.65Near edge of large opening to end of slide .... 12.80–12.85Extremes of large and small openings ............ 30.40–30.45

Jet

Length of jet ..................................................... 18.30–18.40External diameter at end of jet ........................ 2.20–2.60Bore of jet ........................................................ 1.60–1.65Height of jet center above top surface of

cover ............................................................. 11.00–11.20Jet pivot to center of block with cover closed 12.68–12.72

A The O-seal or gasket which provides a seal when thecover is shut, should be made of a heat-resistant material ca-pable of withstanding temperatures up to 150 °C for the low-range apparatus.

B When in position, the thermometer bulb should be sur-rounded with heat-conducting thermoplastic compound, suchas a paste comprised of zinc oxide and mineral oil.


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[51 FR 28539, Aug. 8, 1986]


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§ 1500.44 Method for determining ex-tremely flammable and flammablesolids.

(a) Preparation of samples—(1) Gran-ules, powders, and pastes. Pack the sam-ple into a flat, rectangular metal boatwith inner dimensions 6 inches long × 1inch wide × one-fourth inch deep.

(2) Rigid and pliable solids. Measurethe dimensions of the sample and sup-port it by means of metal ringstands,clamps, rings, or other suitable devicesas needed, so that the major axis is ori-ented horizontally and the maximumsurface is freely exposed to the atmos-phere.

(b) Procedure. Place the preparedsample in a draft-free area that can beventilated and cleared after each test.The temperature of the sample at thetime of testing shall be between 68 °F.and 86 °F. Hold a burning paraffin can-dle whose diameter is at least 1 inch, sothat the flame is in contact with thesurface of the sample at the end of themajor axis for 5 seconds or until thesample ignites, whichever is less. Re-move the candle. By means of a stop-watch, determine the time of combus-tion with self-sustained flame. Do notexceed 60 seconds. Extinguish flamewith a CO2 or similar nondestructivetype extinguisher. Measure the dimen-sions of the burnt area and calculatethe rate of burning along the majoraxis of the sample.

§ 1500.45 Method for determining ex-tremely flammable and flammablecontents of self-pressurized contain-ers.

(a) Equipment required. The testequipment consists of a base 8 incheswide, 2 feet long, marked in 6-inch in-tervals. A rule 2 feet long and markedin inches is supported horizontally onthe side of the base and about 6 inchesabove it. A paraffin candle 1 inch ormore in diameter, and of such heightthat the top third of the flame is at theheight of the horizontal rule, is placedat the zero point in the base.

(b) Procedure. The test is conductedin a draft-free area that can be venti-lated and cleared after each test. Placethe self-pressurized container at a dis-tance of 6 inches from the flamesource. Spray for periods of 15 secondsto 20 seconds (one observer noting the

extension of the flame and the otheroperating the container) through thetop third of the flame and at a rightangle to the flame. The height of theflame should be approximately 2inches. Take three readings for eachtest, and average. As a precaution donot spray large quantities in a small,confined space. Free space of pre-viously discharged material.

§ 1500.46 Method for determiningflashpoint of extremely flammablecontents of self-pressurized contain-ers.

Use the apparatus described in§ 1500.43a. Use some means such as dryice in an open container to chill thepressurized container. Chill the con-tainer, the flash cup, and the bath solu-tion of the apparatus (brine or glycolmay be used) to a temperature of about25 °F below zero. Puncture the chilledcontainer to exhaust the propellant.Transfer the chilled formulation to thetest apparatus and test in accordancewith the method described in § 1500.43a.

[51 FR 28544, Aug. 8, 1986]

§ 1500.47 Method for determining thesound pressure level produced bytoy caps.

(a) Equipment required. The equip-ment for the test includes a micro-phone, a preamplifier (if required), andan oscilloscope.

(1) The microphone-preamplifier sys-tem shall have a free-field responseuniform to within ±2 decibels from 50hertz to 70 kilohertz or beyond and adynamic range covering the interval 70to 160 decibels relative to 20 micronew-tons per square meters. Depending onthe model, the microphone shall beused at normal or at grazing incidence,whichever gives the most uniform free-field response. The microphone shall becalibrated both before and after thetest of a model of cap. The calibrationshall be accurate to within ±1 decibel.If the calibration is of the pressuretype or of the piston-phone plus elec-trostatic actuator type, it shall be cor-rected to free-field conditions in ac-cordance with the manufacturer’s in-structions.

(2) The oscilloscope shall be the stor-age type or one equipped with a cam-era. It shall have a response uniform to


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16 CFR Ch. II (1–1–97 Edition)§ 1500.48

within ±1 decibel from 50 hertz to 250kilohertz or higher. It shall be cali-brated to within ±1 decibel against anexternal voltage source periodicallyduring the tests.

(b) Procedure. (1) Use the type pistolthat would ordinarily be used with thecaps being tested. Place the pistol andtesting equipment so that neither thepistol nor the microphone is closerthan 1 meter from any wall, floor, ceil-ing, or other large obstruction. Locatethe pistol and the microphone in thesame horizontal plane with a distanceof 25 centimeters between the dia-phragm of the microphone and the po-sition of the explosive. Measure thepeak sound pressure level at each ofthe six designated orientations of thepistol with respect to the measuringmicrophone. The 0° orientation cor-responds to the muzzle of the pistolpointing at the microphone. The 90°,180°, and 270° orientations are measuredin a clockwise direction when lookingdown on the pistol with its barrel hori-zontal, as illustrated by the followingfigure:

(2) The hammer and trigger orienta-tions are obtained by rotating the pis-tol about the axis of the barrel, whenthe pistol is in the 90° or 270° orienta-tion, so that the hammer and the trig-ger are each respectively closest to andin the same horizontal plane with themicrophone.

(3) Fire 10 shots at each of the six ori-entations, obtaining readings on theoscilloscope of the maximum peakvoltage for each shot. Average the re-sults of the 10 firings for each of the sixorientations.

(4) Using the orientation that yieldsthe highest average value, convert thevalue to sound pressure levels in deci-bels relative to 20 micronewtons per

square meter using the response to thecalibrated measuring microphone.

§ 1500.48 Technical requirements fordetermining a sharp point in toysand other articles intended for useby children under 8 years of age.

(a) Objective. The sharp point testprescribed by paragraph (d) of this sec-tion will be used by the Commission inmaking a preliminary determinationthat points on toys and other articlesintended for use by children under 8years of age, and such points exposedin normal use or as a result of reason-ably foreseeable damage or abuse ofsuch toys and articles, present a poten-tial risk of injury by puncture or lac-eration under section 2(s) of the Fed-eral Hazardous Substances Act (15U.S.C. 1261(s)). The Commission willfurther evaluate points that are identi-fied as presenting a potential risk ofpuncture or laceration injury to deter-mine the need for individual productregulatory action.

(b) Scope—(1) General. The sharppoint test of paragraph (d) of this sec-tion is applicable to toys or other arti-cles that are introduced into interstatecommerce on or after December 22,1978. The sharp point test shall be ap-plied to any accessible portion of thetest sample before and after subjectingthe test sample to the use and abusetests of §§ 1500.51, 1500.52, and 1500.53(excluding the bite test-paragraph (c)of each section).

(2) Exemptions. (i) Toys and otherchildren’s articles that are the subjectof any of the following regulations areexempt from this § 1500.48: The regula-tions for bicycles, non-full-size babycribs, and full-size baby cribs (parts1508, 1509, and 1512, of this chapter).

(ii) Toys that by reason of their func-tional purpose necessarily present thehazard of sharp points and that do nothave any nonfunctional sharp pointsare exempt from this § 1500.48: Provided,Each toy is identified by a conspicuous,legible, and visible label at the time ofany sale, as having functional sharppoints. An example of such toys is atoy sewing machine with a needle.

(iii) Articles, besides toys, intendedfor use by children that by reason oftheir functional purpose necessarilypresent the hazard of sharp points and


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that do not have any nonfunctionalsharp points are exempt from this§ 1500.48. An example of such articles isa ball-point pen.

(c) Accessibility—(1) General. Anypoint that is accessible either before orafter these tests of §§ 1500.51, 1500.52,and 1500.53 (excluding the bite test—paragraph (c) of each section) are per-formed shall be subject to the sharppoint test of paragraph (d) of this sec-tion.

(2) Accessible points. (i) An accessiblepoint for a toy or article intended forchildren 3 years of age or less is onethat can be contacted by any portionforward of the collar of the accessibil-ity probe designated as probe A in fig-ure 2 of this section.

(ii) An accessible point for a toy orarticle intended for children over 3years up to 8 years of age is one thatcan be contacted by any portion for-ward of the collar of the accessibilityprobe designated as probe B in figure 2of this section.

(iii) An accessible point for a toy orarticle intended for children of agesspanning both age groups is one thatcan be contacted by any portion for-ward of the collar of either probe A orB, as shown in figure 2 of this section.

(3) Insertion depth for accessibility. (i)For any hole, recess, or opening havinga minor dimension (The minor dimen-sion of an opening is the diameter ofthe largest sphere that will passthrough the opening.) smaller than thecollar diameter of the appropriateprobe, the total insertion depth for ac-cessibility shall be up to the collar onthe appropriate probe. Each probe jointmay be rotated up to 90 degrees to sim-ulate knuckle movement.

(ii) For any hole, recess, or openinghaving a minor dimension larger thanthe collar diameter of probe A but lessthan 7.36 inches (186.9 millimeters),when probe A is used, or a minor di-mension larger than the collar diame-ter of probe B but less than 9.00 inches(228.6 millimeters), when probe B isused, the total insertion depth for ac-cessibility shall be determined by in-serting the appropriate probe with theextension shown in figure 2 in any di-rection up to two and one-quartertimes the minor dimension of theprobe, recess, or opening, measured

from any point in the plane of theopening. Each probe joint may be ro-tated up to 90 degrees to simulateknuckle movement.

(iii) For any hole, recess, or openinghaving a minor dimension of 7.36 inches(186.9 millimeters) or larger when probeA is used, or a minor di-mension of 9.00inches (228.6 millimeters), or largerwhen probe B is used, the total inser-tion depth for accessibility is unre-stricted unless other holes, recesses, oropenings within the original hole, re-cess, or opening are encountered withdimensions specified in paragraph (c)(3)(i) or (ii) of this section. In such in-stances, the appropriate paragraphs(c)(3) (i) or (ii) of this section shall befollowed. If both probes are to be used,a minor dimen-sion that is 7.36 inches(186.9 millimeters or larger shall deter-mine unrestricted access.

(4) Inaccessible points. Points shall beconsidered inaccessible without testingwith a probe if they lie adjacent to asurface of the test sample and any gapbetween the point and the adjacentsurface does not exceed 0.020 inch (0.50millimeter) either before or after thetests of §§ 1500.51, 1500.52, and 1500.53(excluding the bite test—paragraph (c)of each section) are performed.

(d) Sharp point test method—(1) Prin-ciple of operation. The principle of oper-ation of the sharp point tester shown infigure 1 of this section is as follows(Detailed engineering drawings for asuggested sharp point tester are avail-able from the Commission’s Office ofthe Secretary.): A rectangular openingmeasuring 0.040 inch (1.02 millimeters)wide by 0.045 inch (1.15 millimeters)long in the end of the slotted cap estab-lishes two reference dimensions. Depthof penetration of the point being testeddetermines sharpness. If the pointbeing tested can contact a sensing headthat is recessed a distance of 0.015 inch(0.38 millimeter) below the end cap andcan move the sensing head a further0.005 inch (0.12 millimeter) against a0.5-pound (2.2-newton) force of a returnspring, the point shall be identified assharp. A sharp point tester of the gen-eral configuration shown in figure 1 ofthis section or one yielding equivalentresults shall identify a sharp point. Inconducting tests to determine the pres-ence of sharp points, the Commission


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16 CFR Ch. II (1–1–97 Edition)§ 1500.48

will use the sharp point tester shown infigure 1 of this section and the acces-sibility probes designated as A or B infigure 2 of this section.

(2) Procedure. (i) The sample to betested shall be held in such a mannerthat it does not move during the test.

(ii) Part of the test sample may needto be removed to allow the sharp pointtesting device to test a point that isaccessible by the criteria of paragraph(c) of this section. Such dismantling ofthe test sample could affect the rigid-ity of the point in question. The sharppoint test shall be performed with thepoint supported so that its stiffness ap-proximates but is not greater than thepoint stiffness in the assembled sam-ple.

(iii) Using the general configurationshown in figure 1 of this section, theadjustment and operation of the sharppoint tester is as follows: Hold thesharp point tester and loosen the lockring by rotating it so that it moves to-wards the indicator lamp assembly asufficient distance to expose the cali-bration reference marks on the barrel.Rotate the gaging can clockwise untilthe indicator lamp lights. Rotate the

cap counterclockwise until an equiva-lent of five divisions (the distance be-tween the short lines on the cap) havepassed the calibration reference mark.Lock the gaging cap in this position byrotating the lock ring until it fits firm-ly against the cap. Insert the pointinto the gaging slot in all directions inwhich it was accessible by the criteriaof paragraph (c) of this section, andapply a force of 1.00 pound (4.45 new-tons). A glowing light identifies thepoint as sharp.

(iv) The test instruments used by theCommission in its tests for compliancewith this regulation shall have gagingslot opening dimensions no greaterthan 0.040 inch by 0.045 inch and shallhave the sensing head recessed a depthof no less than 0.015 inch. The force ap-plied by the Commission when insert-ing a point into the gaging slot shall beno more than 1.00 pound.

(e) For the purpose of conformancewith the technical requirements pre-scribed by this § 1500.48, the English fig-ures shall be used. The metric approxi-mations are provided in parentheses forconvenience and information only.


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§ 1500.49 Technical requirements fordetermining a sharp metal or glassedge in toys and other articles in-tended for use by children under 8years of age.

(a) Objective. The sharp edge testmethod prescribed by paragraph (d) ofthis section will be used by the Com-mission in making a preliminary deter-mination that metal or glass edges ontoys and other articles intended for useby children under 8 years of age, andsuch edges exposed in normal use or asa result of reasonably forseeable dam-age or abuse of such toys and articles,present a potential risk of injury bylaceration or avulsion under section2(s) of the Federal Hazardous Sub-stances Act (15 U.S.C. 1261(s)). TheCommission will further evaluate toysand other articles with edges that areidentified as presenting a potentialrisk of laceration or avulsion injury todetermine the need for individual prod-uct regulation.

(b) Scope—(1) General. The sharp edgetest of paragraph (d) of this section isapplicable to toys or other articles con-taining metal or glass edges that areintroduced into interstate commerceafter March 26, 1979. Such articles man-ufactured outside the United States areintroduced into interstate commercewhen first brought within as U.S. portof entry. Such articles manufactured inthe United States are introduced intointerstate commerce (a) at the time offirst interstate sale, or (b) at the timeof first intrastate sale if one or morecomponents and/or raw materials werereceived interstate, whichever occursearlier.

(2) Exemptions. (i) Toys and otherchildren’s articles that are the subjectof any of the following regulations areexempt from this § 1500.49: The regula-tions for bicycles, non-full-size babycribs, and full-size baby cribs (parts1508, 1509, and 1512 of this chapter).

(ii) Toys that by reason of their func-tional purpose necessarily present thehazard of sharp metal or glass edgesand that do not have any nonfunc-tional sharp metal or glass edges areexempt from this section: Provided, thetoy is identified by a conspicuous, leg-ible, and visible label at the time ofany sale, as having functional sharpmetal or glass edges. Examples of these

are a pair of toy scissors and toy toolkits.

(iii) Articles, besides toys, intendedfor use by children that by reason oftheir functional purpose necessarilypresent the hazard of sharp metal orglass edges and that do not have anynon-functional sharp metal or glassedges are exempt from this section. Ex-amples of these are children’s iceskates and children’s cutlery.

(3) Definitions—(i) Glass. For the pur-pose of this regulation the Commissiondefines glass as a hard, brittle, amor-phous substance produced by fusion,usually consisting of mutually dis-solved silica and silicates that alsocontain soda and lime.

(ii) Metal. For the purpose of this reg-ulation the Commission intends theword metal to include both elementalmetals and metal alloys.

(c) Accessibility—(1) General. Anymetal or glass edge that is accessibleeither before or after the test of§§ 1500.51, 1500.52, and 1500.53 (excludingthe bite test—paragraph (c) of each sec-tion) are performed shall be subject tothe sharp edge test of paragraph (d) ofthis section. Toys reasonably intendedto be assembled by an adult and not in-tended to be taken apart by a childshall be tested only in the assembledstate if the shelf package and the as-sembly instructions prominently indi-cate that the article is to be assembledonly by an adult.

(2) Accessible edges. (i) An accessiblemetal or glass edge for a toy or articleintended for children 3 years of age orless is one that can be contacted byany portion forward of the collar of theaccessibility probe designated as probeA in Figure 2 of this section.

(ii) An accessible edge for a toy or ar-ticle intended for children over 3 yearsand up to 8 years of age is one that canbe contacted by any portion forward ofthe collar of the accessibility probedesignated as Probe B in Figure 2 ofthis section.

(iii) An accessible edge for a toy orarticle intended for children of agesspanning both age groups is one thatcan be contacted by any portion for-ward of the collar of either Probe A orProbe B, as shown in Figure 2 of thissection.


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(3) Insertion depth. (i) For any hole,recess, or opening having a minor di-mension (the minor dimension of anopening is the diameter of the largestsphere that will pass through the open-ing), smaller than the collar diameterof the appropriate probe, the total in-sertion depth for accessibility shall beup to the collar on the appropriateprobe. Each probe joint may be rotatedup to 90 degrees to simulate knucklemovement.

(ii) For any hole, recess, or openinghaving a minor dimension larger thanthe collar diameter of Probe A, but lessthan 7.36 inches (186.9 millimeters),when Probe A is used, or a minor di-mension larger than the collar diame-ter of Probe B, but less than 9.00 inches(228.6 millimeters), when Probe B isused, the total insertion depth for ac-cessibility shall be determined by in-serting the appropriate probe with theextension, shown in Figure 2, in any di-rection up to 21⁄4 times the minor di-mension of the hole, recess, or opening,measured from any point in the planeof the opening. Each probe joint maybe rotated up to 90 degrees to simulateknuckle movement.

(iii) For any hole, recess, or openinghaving a minor dimension of 7.36 inches(186.9 millimeters) or larger whenProbe A is used, or a minor dimensionof 9.00 inches (228.6 millimeters) orlarger when Probe B is used, the totalinsertion depth for accessibility is un-restricted unless other holes, recesses,or openings within the original hole,recess, or opening are encountered withdimensions specified in paragraph (c)(3)(i) or (ii) of this section. In such in-stances, the appropriate paragraphs(c)(3) (i) or (ii) of this section shall befollowed. If both probes are to be used,a minor dimension that is 7.36 inches(186.9 millimeters or larger shall deter-mine unrestricted access.

(4) Inaccessible edges. Metal or glassedges shall be considered inaccessiblewithout testing with a probe if they lieadjacent to a surface of the test sam-ple, and any gap between the edge andthe adjacent surface does not exceed0.020 inch (0.50 millimeter) both beforeand after the tests of §§ 1500.51, 1500.52,and 1500.53 (excluding the bite test—paragraph (c) of each section) are per-formed. For example, in a lap joint in

which a metal edge is overlapped by aparallel surface, any burr or feather-edge on the side closest to the protect-ing parallel surface is considered inac-cessible if the gap between the edgeand the parallel surface is no greaterthan 0.020 inch (0.50 millimeter). As anadditional example, when sheet metalhas a hemmed edge a portion of thesheet adjacent to the edge is foldedback upon itself, approximately 180 de-grees, so that it is roughly parallel tothe main sheet. Any burrs or feather-ing on the inside edge, the side closestto the protecting parallel surface of themain sheet, will be considered inacces-sible if the gap between the inside edgeand the parallel surface does not ex-ceed 0.020 inch (0.50 millimeter).

(d) Sharp edge test method—(1) Prin-ciple of operation. The test shall be per-formed with a sharp edge tester whichcontains a cylindrical mandrel capableof rotation at a constant velocity. (En-gineering drawings for a suitable port-able sharp edge test instrument areavailable from the Commission’s Officeof the Secretary.) The full circum-ference of the mandrel shall bewrapped with a single layer ofpolytetrafluoroethylene (TFE) tape asspecified in paragraph (e)(3) of this sec-tion. The mandrel shall be applied tothe edge to be tested with a normalforce of 1.35 pounds (6.00 Newtons) suchthat the edge contacts the approximatecenter of the width of the tape asshown in Figure 1 of this section. Themandrel shall be rotated through onecomplete revolution while maintainingthe force against the edge constant.Linear motion of the mandrel alongthe line of the edge shall be prevented.The edge shall be identified as sharp ifit completely cuts through the tape fora length of not less than 1⁄2 inch (13millimeters) at any force up to 1.35pounds (6.00 Newtons).

(2) Procedure. (i) The edge of the sam-ple to be tested shall be held in such amanner that it does not move duringthe test. If the full mandrel force of1.35 pounds (6.00 Newtons) causes theedge to bend, a reduced mandrel forcemay be used.

(ii) Part of the test sample may needto be removed to allow the sharp edgetesting device to test an edge that isaccessible by the criteria of paragraph


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1 The tape that the Commission will use forthe sharp edge test is CHR type ‘‘T’’ manu-factured by The Connecticut Hard RubberCo., New and East Streets, New Haven, Conn.06509.

(c) of this section. Such dismantling ofthe test sample could affect the rigid-ity of the edge in question. The sharpedge test shall be performed with theedge supported so that its stiffness ap-proximates but is not greater than theedge stiffness in the assembled sample.

(iii) Conduct of a sharp edge test is asfollows: Wrap one layer of polytetra-fluoroethylene (TFE) tape, described inparagraph (e)(3) of this section, aroundthe full circumference of the mandrelin an unstretched state. The ends ofthe tape shall be either butted or over-lapped not more than 0.10 inch (2.5 mil-limeters). Apply the mandrel, at theapproximate center of the tape, to theedge of the test sample with a force of1.35 pounds (6.00 Newtons) measured ina direction at right angles to the man-drel axis. The mandrel shall be placedso that its axis is at 90 degrees ±5 de-grees to the line of a straight test edgeor 90 degrees ±5 degrees to a tangent atthe point of contact with a curved testedge. The point of contact between thetest edge and the mandrel shall be inthe approximate center of the width ofthe tape. The axis of the mandrel maybe positioned anywhere in a planewhich is at right angles to either theline of a straight test edge or to a tan-gent at the point of contact with acurved test edge. The operator shouldseek the orientation most likely tocause the edge to cut the tape. Main-tain the force against the edge and ro-tate the mandrel through one completerevolution while preventing any linearmotion of the mandrel along the edge.Release the mandrel from the edge andremove the tape without enlarging anycut or causing any score to become acut. A cut in the tape with a length ofnot less than 1⁄2 inch (13 millimeters)identifies an edge as sharp. (The testinstruments used by the Commission inits test for compliance with the regula-tion will be calibrated to insure thatthe force with which the mandrel is ap-plied to a test edge does not exceed 1.35pounds.)

(e) Specifications for sharp edge testequipment. The following specificationsshall apply to the equipment to be usedin the sharp edge test described inparagraph (d) of this section:

(1) The rotation of the mandrel shallproduce a constant tangential velocity

of 1.00±0.08 inch per second (25.4±2.0millimeters per second) during the cen-ter 75 percent of its rotation and shallhave a smooth start and stop.

(2) The mandrel shall be made ofsteel. The test surface of the mandrelshall be free of scratches, nicks, orburrs and shall have a surface rough-ness no greater than 16 microinches(0.40 micron). The test surface shallhave a hardness no less than 40 asmeasured on the Rockwell ‘‘C’’ scale,as determined pursuant to ASTM E 18–74 entitled ‘‘Standard Test Methods forRockwell Hardness and Rockwell Su-perficial Hardness of Metallic Mate-rials,’’ published July 1974 and which isincorporated by reference in this regu-lation. (Copies are available fromAmerican Society for Testing and Ma-terials, 1916 Race Street, Philadelphia,Pa. 19103.) The diameter of the mandrelshall be 0.375±0.005 inch (9.35±0.12 milli-meters). The mandrel shall be of suit-able length to carry out the test.

(3) The tape shall be pressure-sen-sitive polytetrafluoroethylene (TFE)high temperature electrical insulationtape as described in Military Specifica-tion MIL–I–23594B (1971) which is incor-porated by reference in this regulation.(Copies are available from Naval Publi-cations and Forms Center, 5801 TaborAve., Philadelphia, Pa. 19120.) Thethickness of the polytetrafluoro-ethylene backing shall be between0.0026 inch (0.066 millimeter) and 0.0035inch (0.089 millimeter).1 The adhesiveshall be pressure-sensitive siliconepolymer with a nominal thickness of0.003 inch (.08 millimeter). The width ofthe tape shall not be less than 1⁄4 inch(6 millimeters). While conducting sharpedge tests the temperature of the tapeshall be maintained between 70 °F (21.1°C) and 80 °F (26.6 °C).

(f) For the purpose of conformancewith the technical requirements pre-scribed by this § 1500.49, the English fig-ures shall be used. The metric approxi-mations are provided in parentheses forconvenience and information only.


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(Secs. 2(s), 10(a), 74 Stat. 378 (15 U.S.C. 1261,1269))

[43 FR 12645, Mar. 24, 1978, as amended at 43FR 21324, May 17, 1978]

§ 1500.50 Test methods for simulatinguse and abuse of toys and other ar-ticles intended for use by children.

(a) Objective. The objective of§§ 1500.51, 1500.52, and 1500.53 is to de-scribe specific test methods for simu-lating normal use of toys and other ar-ticles intended for use by children aswell as the reasonably foreseeable dam-age or abuse to which the articles maybe subjected. The test methods are foruse in exposing potential hazards thatwould result from the normal use orthe reasonably foreseeable damage orabuse of such articles intended for chil-dren.

(b) Application—general. (1)(i) The testmethods described in §§ 1500.51, 1500.52and 1500.53 are to be used in determin-ing what is normal use and reasonablyforeseeable damage or abuse when spe-cifically referenced under § 1500.18.Other banning regulations may alsoreference these use and abuse toy testprocedures.

(ii) The test methods described in§§ 1500.51, 1500.52, and 1500.53 have beenestablished for articles intended for thespecified age groups of children: 18months of age or less, over 18 monthsbut not over 36 months of age, and over36 months but not over 96 months ofage. If an article is marked, labeled,advertised, or otherwise intended forchildren of ages spanning more thanone of these age groups, the article willbe subjected to the tests providing themost stringent requirements. If an ar-ticle is not age-labeled in a clear andconspicuous manner or, based on suchfactors as marketing practices and thecustomary patterns of usage of a prod-uct by children, is inappropriately age-labeled, and is intended or appropriatefor children 96 months of age or less, itwill also be subjected to the moststringent test requirements.

(2) For purposes of compliance withthe test methods prescribed in§§ 1500.51, 1500.52, and 1500.53, the Eng-lish system shall be used. The metricapproximations are provided in paren-theses for convenience and informationonly.

(3) Each of the test methods de-scribed in §§ 1500.51, 1500.52, and 1500.53shall be applied to a previouslyuntested sample except the tensiontest which shall be conducted with thetest sample used in the torque test.

(4) Prior to testing, each sample shallbe subjected to a temperature of 73°±3°F. (23°±2 °C.) as a relative humidity of20¥70 percent for a period of at least 4hours. The toy testing shall commencewithin five minutes after the toy hasbeen removed from the preconditioningatmosphere.

(5) Toys reasonably intended to be as-sembled by an adult and not intendedto be taken apart by a child shall betested only in the assembled state ifthe shelf package and the assembly in-structions prominently indicate thatthe article is to be assembled only byan adult.

(6) Toys intended to be repeatedly as-sembled and taken apart shall have theindividual pieces as well as the com-pleted article subjected to these testprocedures.

(7) In situations where a test proce-dure may be applied in more than oneway to a toy test component, the point(or direction) of force (or torque) appli-cation which results in the most severeconditions shall be used.

(c) Definitions. As used in this sectionand in §§ 1500.51, 1500.52, and 1500.53:

(1) Toy means any toy, game, orother article designed, labeled, adver-tised, or otherwise intended for use bychildren.

(2) Mouth toy means any toy reason-ably intended to be placed into or incontact with a child’s mouth.

[40 FR 1483, Jan. 7, 1975; 40 FR 16191, Apr. 10,1975]

§ 1500.51 Test methods for simulatinguse and abuse of toys and other ar-ticles intended for use by children18 months of age or less.

(a) Application. The test methods de-scribed in this section shall be used tosimulate the normal and reasonablyforeseeable use, damage, or abuse oftoys and other articles intended for useby children 18 months of age or less inconjunction with § 1500.18.

(b) Impact test—(1) Application. Exceptas provided in paragraph (b)(4) of thissection, toys having a weight of less


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1 These documents may be ordered from theGeneral Services Administration, Specifica-tions Unit, Room 6654, 7th and D Streets,S.W., Washington, DC 20407. The price of thespecification and amendment is $1.00.

than 3.0 pounds ±0.01 pound (1.4 kilo-grams) shall be subject to this test.

(2) Impact medium. The impact me-dium shall consist of a 1⁄8-inch (0.3-cen-timeter) nominal thickness of type IVvinyl-composition tile, composition 1—asbestos free, as specified by para-graphs 1.2 and 3.1.4 of Interim Amend-ment-1(YD), dated November 14, 1979,to the Federal Specification entitledTile, Floor: Asphalt, Rubber, Vinyl,Vinyl-Asbestos, SS–T–312B, dated Octo-ber 10, 1974,1 over at least a 2.5-inch(6.4-centimeter) thickness of concrete.The impact area shall be at least 3square feet (0.3 square meter). TheCommission recognizes that this speci-fied impact medium is the equivalentof, and will yield the same impact testresults as, a surface covered withvinyl-asbestos tile meeting the require-ments of Federal Specification SS–T–312A.

(3) Testing procedure. Except as pro-vided in paragraphs (b)(4) (i) and (ii) ofthis section, the toy shall be dropped 10times from a height of 4.5 feet ±0.5 inch(1.37 meters) onto the impact mediumdescribed in paragraph (b)(2) of thissection. The toy shall be dropped inrandom orientation. After each drop,the test sample shall be allowed tocome to rest and shall be examined andevaluated before continuing.

(4) Large and bulky toys. (i) A toy thathas a projected base area of 400 or moresquare inches (2,560 or more square cen-timeters), shall be tested for impact inaccordance with paragraph (b)(4)(iii) ofthis section. The base area for toyswith permanently attached legs shallbe measured by calculating the areaenclosed by straight lines connectingthe outermost edge of each leg of theperimeter.

(ii) A toy that has a volume of morethan 3 cubic feet (0.085 cubic meter),calculated by the major dimensionswithout regard to minor appendages,shall be tested for impact in accord-ance with paragraph (b)(4)(iii) of thissection.

(iii) The toys described in paragraph(b)(4)(i) and (ii) of this section shall be

tested for impact by tipping them overthree times by pushing the samplesslowly past their centers of balanceonto the impact medium described inparagraph (b)(2) of this section.

(c) Bite test—(1) Application. A toy (orcomponent or any accessible portionthereof) that has an external dimen-sion of 1.25 inches ±0.05 inch (3.18 centi-meters) or less and a design configura-tion that would permit a child to inserta portion into the mouth in any ori-entation up to a biting thickness of 1.25inches ±0.05 inch (3.18 centimeters), fora penetration of at least 0.25 inch (0.635centimeter), shall be subject to thistest.

(2) Test equipment—(i) Contact mecha-nism. The contact mechanism shall betwo metal strips or plates each measur-ing 0.25 inch ±0.002 inch (0.635 centi-meter) high and each having a contactedge radius of 0.020 inch ±0.002 inch (0.05centimeter), for at least a 150-degreecross-sectional arc. A suggested con-tact mechanism appears in figure 1 ofthis section.

(ii) Loading device. The loading deviceshall be a scale or force gauge havingan accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. The test articleshall be placed in the contact mecha-nism in any reasonable position for apenetration of 0.25 to 0.5 inch (0.64 to1.27 centimeters), which position uti-lizes less than 180 degrees of the arc ofthe contact mechanism, and a test loadincreasing to 25 pounds ±0.5 pound(11.35 kilograms) shall be evenly ap-plied within 5 seconds. This load shallbe maintained for an additional 10 sec-onds.

(d) Flexure test—(1) Application. Thistest shall be applied to each componentof a toy containing metal wire(s), orother metal material(s), for stiffeningor for retention of form if the compo-nent can be bent through a 60-degreearc by a maximum force of 10 pounds±0.5 pound (4.55 kilograms), applied per-pendicularly to the major axis of thecomponent at a point 2 inches (5 centi-meters) from the intersection of thecomponent with the main body of thetoy or at the end of the component ifthe component is less than 2 inches±0.05 inch (5 centimeters) long.

(2) Testing procedure. The toy shall besecured in a vise equipped with vise


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shields that are fabricated from 13-gauge cold-rolled steel or other similarmaterial and that have a 0.375-inch(0.95-centimeter) inside radius. Thecomponent shall then be bent througha 60-degree arc by a force applied at apoint on the component 2 inches ±0.05inch (5 centimeters) from the intersec-tion of the component with the mainbody of the toy or applied at the end ofthe component if the component is lessthan 2 inches (5 centimeters) long. Thecomponent shall then be bent in the re-verse direction through a 120-degreearc. This process shall be repeated for30 cycles at a rate of one cycle per twoseconds with a 60-second rest period oc-curring after each 10 cycles. Two 120-degree arc bends shall constitute onecycle.

(e) Torque test—(1) Application—(i)General. A toy with a projection, part,or assembly that a child can grasp withat least the thumb and forefinger orthe teeth shall be subject to this test.

(ii) Toys with rotating components.Projections, parts, or assemblies thatare rigidly mounted on an accessiblerod or shaft designed to rotate alongwith the projections, parts, or assem-blies shall be tested with the rod orshaft clamped to prevent rotation.

(2) Test equipment—(i) Loading device.The loading device shall be a torquegauge, torque wrench, or other appro-priate device having an accuracy of ≤0.2 inch-pound (≤0.23 kilogram-centi-meter).

(ii) Clamp. The clamp shall be capableof holding the test component firmlyand transmitting a torsional force.

(3) Testing procedure. With the toyrigidly fastened in any reasonable testposition, the clamp is fastened to thetest object or component. A torque of 2inch-pounds ±0.2 inch-pound (2.30 kilo-gram-centimeters) shall be appliedevenly within a period of 5 seconds in aclockwise direction until a rotation of180 degrees from the original positionhas been attained or 2 inch-pounds (2.30kilogram-centimeters) exceeded. Thetorque or maximum rotation shall bemaintained for an additional 10 sec-onds. The torque shall then be removedand the test component permitted toreturn to a relaxed condition. This pro-cedure shall then be repeated in acounterclockwise direction.

(f) Tension test—(1) Application—(i)General. Any projection of a toy thatthe child can grasp with at least thethumb and forefinger or the teeth shallbe subject to this test. This test is tobe conducted on the same toy that hasbeen subjected to the torque test de-scribed in paragraph (e) of this section.

(ii) Stuffed toys and beanbags. Astuffed toy or beanbag constructed ofpliable materials having seams (suchas fabrics) shall have the seams sub-jected to 10 pounds ±0.5 pound (4.55kilograms) of force applied in any di-rection.

(2) Test equipment—(i) Clamps. Oneclamp capable of applying a tensionload to the test component is required.A second clamp suitable for applying atension load perpendicularly to themajor axis of the test component isalso required.

(ii) Loading device. The loading deviceis to be a self-indicating gauge or otherappropriate means having an accuracyof ±0.5 pound (±225 grams).

(3) Testing procedure. With the testsample fastened in a convenient posi-tion, an appropriate clamp shall be at-tached to the test object or component.A 10-pound ±0.5 pound (4.55–kilogram)direct force shall be evenly applied,within a period of 5 seconds, parallel tothe major axis of the test componentand maintained for an additional 10seconds. The tension clamp shall thenbe removed and a second clamp appro-priate for pulling at 90 degrees shall beattached to the test object or compo-nent. A 10-pound ±0.5 pound (4.55-kilo-gram) tensile force shall be evenly ap-plied, within a period of 5 seconds, per-pendicularly to the major axis of thetest component and maintained for anadditional 10 seconds.

(g) Compression test—(1) Application.Any area on the surface of a toy that isaccessible to a child and inaccessible toflat-surface contact during the impacttest shall be subject to this test.

(2) Test apparatus. The loading deviceshall be a rigid metal disc 1.125 inches±0.015 inch (2.86 centimeters) in diame-ter and 0.375 inch (0.95 centimeter) inthickness. The perimeter of the discshall be rounded to a radius of 1⁄32 inch(0.08 centimeter) to eliminate irregularedges. The disc shall be attached to an


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appropriate compression scale havingan accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. The disc shall bepositioned so that the contact surfaceis parallel to the surface under test. Adirect force of 20 pounds ±0.5 pound (9.1

kilograms) shall be evenly appliedwithin 5 seconds through the disc. Thisload shall be maintained for an addi-tional 10 seconds. During the test thetoy is to rest on a flat, hard surface inany convenient position.

[40 FR 1484, Jan. 7, 1975; 40 FR 6210, Feb. 10,1975; 40 FR 16192, Apr. 10, 1975; 40 FR17746, Apr. 22, 1975; as amended at 55 FR

52040, Dec. 19, 1990; 56 FR 9, Jan. 2, 1991;56 FR 558, Jan. 7, 1991]


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1 See footnote 1 to § 1500.51.

§ 1500.52 Test methods for simulatinguse and abuse of toys and other ar-ticles intended for use by childrenover 18 but not over 36 months ofage.

(a) Application. The test methods de-scribed in this section, shall be used tosimulate the normal and reasonablyforeseeable use, damage, or abuse oftoys and other articles intended for useby children over 18 but not over 36months of age in conjunction with§ 1500.18.

(b) Impact test—(1) Application. Exceptas provided in paragraph (b)(4) of thissection, toys having a weight of lessthan 4.0 pounds ±0.01 pound (1.8 kilo-grams) shall be subject to this test.

(2) Impact medium. The impact me-dium shall consist of a 1⁄8-inch (0.3-cen-timeter) nominal thickness of type IVvinyl-composition tile, composition 1—asbestos free, as specified by para-graphs 1.2 and 3.1.4 of Interim Amend-ment-1(YD), dated November 14, 1979,to the Federal Specification entitledTile, Floor: Asphalt, Rubber, Vinyl,Vinyl-Asbestos, SS–T–312B, dated Octo-ber 10, 1974,1 over at least a 2.5-inch(6.4-centimeter) thickness of concrete.The impact area shall be at least 3square feet (0.3 square meter). TheCommission recognizes that this speci-fied impact medium is the equivalentof, and will yield the same impact testresults as, a surface covered withvinyl-asbestos tile meeting the require-ments of Federal Specification SS–T–312A.

(3) Testing procedure. Except as pro-vided in paragraph (b)(4) (i) and (ii) ofthis section, the toy shall be droppedfour times from a height of 3 feet ±0.5inch (0.92 meter) onto the impact me-dium described in paragraph (b)(2) ofthis section. The toy shall be droppedin random orientation. After each drop,the test sample shall be allowed tocome to rest and shall be examined andevaluated before continuing.

(4) Large and bulky toys. (i) A toy thathas a projected base area of 400 or moresquare inches (2,560 or more square cen-timeters) shall be tested for impact inaccordance with paragraph (b)(4)(iii) ofthis section. The base area for toyswith permanently attached legs shall

be measured by calculating the areaenclosed by straight lines connectingthe outermost edge of each leg of theperimeter.


(iii) The toys described in paragraph(b)(4) (i) and (ii) of this section shall betested for impact by tipping them overthree times by pushing the samplesslowly past their centers of balanceonto the impact medium described inparagraph (b)(2) of this section.

(c) Bite test—(1) Application. A toy (orcomponent or any accessible portionthereof) that has an external dimen-sion of 1.25 inches ±0.05 inch (3.18 centi-meters) or less and a design configura-tion that would permit a child to inserta portion into the mouth in any ori-entation up to a biting thickness of 1.25inches ±0.05 inches (3.18 centimeters),for a penetration of at least 0.25 inch(0.635 centimeter), shall be subject tothis test.

(2) Test equipment—(i) Contact mecha-nism. The contact mechanism shall betwo metal strips or plates each measur-ing 0.25 inch ±0.002 inch (0.635 centi-meter) high and each having a contactedge radius of 0.020 inch ±0.002 inch (0.05centimeter) for at least a 150-degreecross-sectional arc. A suggested con-tact mechanism appears in figure 1 of§ 1500.51.


(3) Testing procedure. The test articleshall be placed in the contact mecha-nism in any reasonable position for apenetration of 0.25 to 0.5 inch (0.64 to1.27 centimeters), which position uti-lizes less than 180 degrees of the arc ofthe contact mechanism, and a test loadincreasing to 50 pounds ±0.5 pound(22.74 kilograms) shall be evenly ap-plied within 5 seconds. This load shallbe maintained for an additional 10 sec-onds.

(d) Flexure test—(1) Application. Thistest shall be applied to each componentof a toy containing metal wire(s), orother metal material(s), for stiffening


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16 CFR Ch. II (1–1–97 Edition)§ 1500.52

or for retention of form if the compo-nent can be bent through a 60-degreearc by a maximum force of 15 pounds±0.5 pound (6.80 kilograms) applied per-pendicularly to the major axis of thecomponent at a point 2 inches ±0.05inch (5 centimeters) from the intersec-tion of the component with the mainbody of the toy or at the end of thecomponent if the component is lessthan 2 inches ±0.05 inch (5 centimeters)long.

(2) Testing procedure. The toy shall besecured in a vise equipped with viseshields that are fabricated from 13-gauge cold-rolled steel or other similarmaterial and that have a 0.375-inch(0.95-centimeter) inside radius. Thecomponent shall then be bent througha 60-degree arc by a force applied at apoint on the component 2 inches ±0.05inch (5 centimeters) from the intersec-tion of the component with the mainbody of the toy or applied at the end ofthe component if the component is lessthan 2 inches (5 centimeters) long. Thecomponent shall then be bent in the re-verse direction through a 120-degreearc. This process shall be repeated for30 cycles at a rate of one cycle per twoseconds with a 60-second rest period oc-curring after each 10 cycles. Two 120-degree arc bends shall constitute onecycle.



(2) Test equipment—(i) Loading device.The loading device shall be a torquegauge, torque wrench, or other appro-priate device having an accuracy of ±0.2inch-pound (±0.23 kilogram-centi-meter).


(3) Testing procedure. With the toyrigidly fastened in any reasonable testposition, the clamp is fastened to thetest object or component. A torque of 3

inch-pounds ±0.2 inch-pound (3.46 kilo-gram-centimeters) shall be appliedevenly within a period of 5 seconds in aclockwise direction until a rotation of180 degrees from the original positionhas been attained or 3 inch-pounds ±0.2inch-pound (3.46 kilogram-centimeters)exceeded. The torque or maximum ro-tation shall be maintained for an addi-tional 10 seconds. The torque shall thenbe removed and the test componentpermitted to return to a relaxed condi-tion. This procedure shall then be re-peated in a counterclockwise direction.




(ii) Loading device. The loading deviceis to be a self-indicating gauge or otherappropriate means having an accuracyof ±0.5 pound (±255 grams).

(3) Testing procedure. With the testsample fastened in a convenient posi-tion, an appropriate clamp shall be at-tached to the test object or component.A 15-pound ±0.5 pound (6.80-kilogram)direct force shall be evenly applied,within a period of 5 seconds, parallel tothe major axis of the test componentand maintained for an additional 10seconds. The tension clamp shall thenbe removed and a second clamp appro-priate for pulling at 90 degrees shall beattached to the test object or compo-nent. A 15-pound ±0.5 pound (6.80-kilo-gram) tensile force shall be evenly ap-plied, within a period of 5 seconds, per-pendicularly to the major axis of thetest component and maintained for anadditional 10 seconds.


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(2) Test apparatus. The loading deviceshall be a rigid metal disc 1.125inches±0.015 inch (2.86 centimeters) indiameter and 0.375 inch (0.95 centi-meter) in thickness. The perimeter ofthe disc shall be rounded to a radius of1⁄32 inch (0.08 centimeter) to eliminateirregular edges. The disc shall be at-tached to an appropriate compressionscale having an accurancy of ±0.5 pound(±225 grams).

(3) Testing procedure. The disc shall bepositioned so that the contact surfaceis parallel to the surface under test. Adirect force of 25 pounds ±0.5 pound(11.4 kilograms) shall be evenly appliedwithin 5 seconds through the disc. Thisload shall be maintained for an addi-tional 10 seconds. During the test thetoy is to rest on a flat, hard surface inany convenient position.

[40 FR 1485, Jan. 7, 1975; 40 FR 6210, Feb. 10,1975; 40 FR 16192, Apr. 10, 1975; as amended at56 FR 10, Jan. 2, 1991]

§ 1500.53 Test methods for simulatinguse and abuse of toys and other ar-ticles intended for use by childrenover 36 but not over 96 months ofage.

(a) Application. The test methods de-scribed in this section shall be used tosimulate the normal and reasonablyforeseeable use, damage, or abuse oftoys and other articles intended for useby children over 36 but not over 96months of age in conjunction with§ 1500.18.

(b) Impact test—(1) Application. Exceptas provided in paragraph (b)(4) of thissection, toys having a weight of lessthan 10.0 pounds ±0.01 pound (4.6 kilo-grams) shall be subject to this test.

(2) Impact medium. The impact me-dium shall consist of a 1⁄8-inch (0.3-cen-timeter) nominal thickness of type IVvinyl-composition tile, composition 1—asbestos free, as specified by para-graphs 1.2 and 3.1.4 of Interim Amend-ment-1(YD), dated November 14, 1979,to the Federal Specification entitledTile, Floor: Asphalt, Rubber, Vinyl,Vinyl-Asbestos, SS–T–312B, dated Octo-ber 10, 1974,1 over at least a 2.5-inch

(6.4-centimeter) thickness of concrete.The impact area shall be at least 3square feet (0.3 square meter). TheCommission recognizes that this speci-fied impact medium is the equivalentof, and will yield the same impact testresults as, a surface covered withvinyl-asbestos tile meeting the require-ments of Federal Specification SS–T–312A.

(3) Testing procedure. except as pro-vided in paragraph (b)(4) (i) and (ii) ofthis section, the toy shall be droppedfour times from a height of 3 feet ±0.5inch (0.92 meter) onto the impact me-dium described in paragraph (b)(2) ofthis section. The toy shall be droppedin random orientation. After each drop,the test sample shall be allowed tocome to rest and shall be examined andevaluated before continuing.

(4) Large and bulky toys. (i) A toy thathas a projected base area of 400 or moresquare inches (2,560 or more square cen-timeters) shall be tested for impact inaccordance with paragraph (b)(4)(iii) ofthis subsection. The base area for toyshaving permanently attached legs shallbe measured by calculating the areaenclosed by straight lines connectingthe outermost edge of each leg of theperimeter.


(iii) The toys described in paragraph(b)(4) (i) and (ii) of this section shall betested for impact by tipping them overthree times by pushing the samplesslowly past their centers of balanceonto the impact medium described inparagraph (b)(2) of this section.

(c) Bite test—(1) Application. A toy (orcomponent) that is a mouth toy shallbe subject to this test.

(2) Test equipment—(i) Contact mecha-nism. The contact mechanism shall betwo metal strips or plates each measur-ing 0.25 inch ±0.002 inch (0.635 centi-meter) high and each having a contactedge radius of 0.020 inch ±0.002 inch (0.5centimeter) for at least a 150-degreecross-sectional arc. A suggested con-tact mechanism appears in figure 1 of§ 1500.51.


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(3) Testing procedure. The test articleshall be placed in the contact mecha-nism in any reasonable position for apenetration of 0.25 to 0.5 inch (0.64 to1.27 centimeters), which position uti-lizes less than 180 degrees of the arc ofthe contract mechanism, and a testload increasing to 100 pounds ±0.5pound (45.50 kilograms) shall be evenlyapplied within 5 seconds. This loadshall be maintained for an additional 10seconds.

(d) Flexure test—(1) Application. Thistest shall be applied to each componentof a toy containing metal wire(s), orother metal material(s), for stiffeningor for retention of form if the compo-nent can be bent through a 60-degreearc by a maximum force of 15 pounds±0.5 pound (6.80 kilograms) applied per-pendicularly to the major axis of thecomponent at a point 2 inches ±0.05inch (5 centimeters) from the intersec-tion of the component with the mainbody of the toy or at the end of thecomponent if the component is lessthan 2 inches ±0.05 inch (5 centimeters)long.

(2) Testing procedure. The toy shall besecured in a vise equipped with viseshields that are fabricated from 13-gauge cold-rolled steel or other similarmaterial and that have a 0.375-inch(0.95-centimeter) inside radius. Thecomponent shall then be bent througha 60-degree arc by a force applied at apoint on the component 2 inches (5 cen-timeters) from the intersection of thecomponent with the main body of thetoy or applied at the end of the compo-nent if the component is less than 2inches (5 centimeters) long. The com-ponent shall then be bent in the re-verse direction through a 120-degreearc. This process shall be repeated for30 cycles at a rate of one cycle per twoseconds with a 60-second rest period oc-curring after each 10 cycles. Two 120-degree arc bends shall constitute onecycle.



(2) Test equipment—(i) Loading device.The loading device shall be a torquegauge, torque wrench, or other appro-priate device having an accuracy of ±0.2inch-pound (±0.23 kilogram-centi-meter).


(3) Testing procedure. With the toyrigidly fastened in any reasonable testposition, the clamp is fastened to thetest object or component. A torque of 4inch-pounds ±0.2 inch-pound (4.60 kilo-gram-centimeters) shall be appliedevenly within a period of 5 seconds in aclockwise direction until a rotation of180 degrees from the original positionhas been attained or 4 inch-pounds ±0.2inch-pound (4.60 kilogram-centimeters)exceeded. The torque or maximum ro-tation shall be maintained for an addi-tional 10 seconds. The torque shall thenbe removed and the test componentpermitted to return to a relaxed condi-tion. This procedure shall then be re-peated in a counterclockwise direction.




(ii) Loading device. The loading deviceis to be a self-indicating gauge or other


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appropriate means having an accuracyof ±0.5 pound (±225 grams).

(3) Testing procedure. With the testsample fastened in a convenient posi-tion, and appropriate clamp shall be at-tached to the test object or component.A 15-pound ±0.5 pound (6.80-kilogram)direct force shall be evenly applied,within a period of 5 seconds, parallel tothe major axis of the test componentand maintained for an additional 10seconds. The tension clamp shall thenbe removed and a second clamp appro-priate for pulling at 90 degrees shall beattached to the test object or compo-nent. A 15-pound ±0.5 pound (6.80-kilo-gram) tensile force shall be evenly ap-plied, within a period of 5 seconds, per-pendicularly to the major axis of thetest component and maintained for anadditional 10 seconds.


(2) Test apparatus. The loading deviceshall be a rigid metal disc 1.125 inches±0.015 inch (2.86 centimeters) in diame-ter and 0.375 inch (0.95 centimeter) inthickness. The perimeter of the discshall be rounded to a radius of 1⁄32 inch(0.08 centimeter) to eliminate irregularedges. The disc shall be attached to anappropriate compression scale havingan accuracy of ±0.5 pound (±225 grams).

(3) Testing procedure. The disc shall bepositioned so that the contact surfaceis parallel to the surface under test. Adirect force of 30 pounds ±0.5 pound(13.6 kilograms) shall be evenly appliedwithin 5 seconds through the disc. Thisload shall be maintained for an addi-tional 10 seconds. During the test thetoy is to rest on a flat, hard surface inany convenient position.

[40 FR 1486, Jan. 7, 1975; 40 FR 16192, Apr. 10,1975, as amended by 56 FR 10, Jan. 2, 1991]

§ 1500.81 Exemptions for food, drugs,cosmetics, and fuels.

(a) Food, drugs, and cosmetics. Sub-stances subject to the Federal Food,Drug, and Cosmetic Act are exemptedby section 2(f)(2) of the act; but wherea food, drug, or cosmetic offers a sub-stantial risk of injury or illness fromany handling or use that is customaryor usual it may be regarded as mis-

branded under the Federal Food, Drug,and Cosmetic Act because its labelfails to reveal material facts with re-spect to consequences that may resultfrom use of the article (21 U.S.C. 321(n))when its label fails to bear informationto alert the householder to this hazard.

(b) Fuels. A substance intended to beused as a fuel is exempt from the re-quirements of the act when in contain-ers that are intended to be or are in-stalled as part of the heating, cooling,or refrigeration system of a house. Aportable container used for delivery ortemporary or additional storage, andcontaining a substance that is a haz-ardous substance as defined in section2(f) of the act, is not exempt from thelabeling prescribed in section 2(p) ofthe act, even though it contains a fuelto be used in the heating, cooking, orrefrigeration system of a house.

§ 1500.82 Exemption from full labelingand other requirements.

(a) Any person who believes a par-ticular hazardous substance intendedor packaged in a form suitable for usein the household or by children shouldbe exempted from full label complianceotherwise applicable under the act, be-cause of the size of the package or be-cause of the minor hazard presented bythe substance, or for other good andsufficient reason, may submit to theCommission a request for exemptionunder section 3(c) of the act, presentingfacts in support of the view that fullcompliance is impracticable or is notnecessary for the protection of the pub-lic health. The Commission shall deter-mine on the basis of the facts submit-ted and all other available informationwhether the requested exemption isconsistent with adequate protection ofthe public health and safety. If theCommission so finds, it shall detail theexemption granted and the reasonstherefor by an appropriate order pub-lished in the FEDERAL REGISTER.

(b) The Commission may on its owninitiative determine on the basis offacts available to it that a particularhazardous substance intended orpackaged in a form suitable for use inthe household or by children should beexempted from full labeling compli-ance otherwise applicable under the actbecause of the size of the package or


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because of the minor hazard presentedby the substance or for other good andsufficient reason. If the Commission sofinds, it shall detail the exemptiongranted and the reasons therefor by anappropriate order in the FEDERAL REG-ISTER.

(c) Any person who believes a par-ticular article should be exemptedfrom being classified as a ‘‘banned haz-ardous substance’’ as defined by sec-tion 2(q)(1)(A) of the act (repeated in§ 1500.3(b)(15)(i)(A)), because its func-tional purpose requires inclusion of ahazardous substance, it bears labelinggiving adequate directions andwarnings for safe use, and it is in-tended for use by children who have at-tained sufficient maturity, and mayreasonably be expected, to read andheed such directions and warnings,may submit to the Commission a re-quest for exemption under section2(q)(1)(B)(i) of the act (repeated in pro-viso (1) under § 1500.3(b)(15(i)), present-ing facts in support of his contention.The commission shall determine on thebasis of the facts submitted, and allother available information, whetherthe requested exemption is consistentwith the purposes of the act. If theCommission so finds, it shall detail theexemption granted and the reasonstherefor by an appropriate order in theFEDERAL REGISTER.

(d) On its own initiative, the Com-mission may determine on the basis ofavailable facts that a particularbanned hazardous substance should beexempted from section 2(q)(1)(A) of theact (repeated in § 1500.3(b)(15)(i)(A)), be-cause its functional purpose requiresinclusion of a hazardous substance, itbears labeling giving adequate direc-tions and warnings for safe use, and itis intended for use by children whohave obtained sufficient maturity, andmay reasonably be expected, to readand heed such directions and warnings.If the Commission so finds, it shall de-tail the exemption granted and the rea-sons therefor by an appropriate orderin the FEDERAL REGISTER.

§ 1500.83 Exemptions for small pack-ages, minor hazards, and specialcircumstances.

(a) The following exemptions aregranted for the labeling of hazardous

substances under the provisions of§ 1500.82:

(1) When the sole hazard from a sub-stance in a self-pressurized container isthat it generates pressure or when thesole hazard from a substance is that itis flammable or extremely flammable,the name of the component which con-tributes the hazards need not be stated.

(2) Common matches, including bookmatches, wooden matches, and so-called ‘‘safety’’ matches are exemptfrom the labeling requirements of sec-tion 2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)) insofar as they applyto the product being considered hazard-ous because of being ‘‘flammable’’ or‘‘extremely flammable’’ as defined in§ 1500.3(c)(6)(iii) and (iv).

(3) Paper items such as newspapers,wrapping papers, toilet and cleansingtissues, and paper writing supplies areexempt from the labeling requirementsof section 2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)) insofar as they applyto the products being considered haz-ardous because of being ‘‘flammable’’or ‘‘extremely flammable’’ as definedin § 1500.3(c)(6)(iii) and (iv).

(4) Thread, string, twine, rope, cord,and similar materials are exempt fromthe labeling requirements of section2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)) insofar as they applyto the products being considered haz-ardous because of being ‘‘flammable’’or ‘‘extremely flammable’’ as definedin § 1500.3(c)(6) (iii) and (iv).

(5) Laboratory chemicals intendedonly for research or investigationaland other laboratory uses (except thosein home chemistry sets) are exemptfrom the requirements of placementprovided in § 1500.121 if all informationrequired by that section and the actappears with the required prominenceon the label panel adjacent to the mainpanel.

(6) [Reserved](7) Rigid or semirigid ballpoint ink

cartridges are exempt from the label-ing requirements of section 2(p)(1) ofthe act (repeated in § 1500.3(b)(14)(i)),insofar as such requirements would benecessary because the ink containedtherein is a ‘‘toxic’’ substance as de-fined in § 1500.3(c)(2)(i), if:

(i) The ballpoint ink cartridge is ofsuch construction that the ink will,


437


under any reasonably foreseeable con-ditions of manipulation or use, emergeonly from the ballpoint end;

(ii) When tested by the method de-scribed in § 1500.3(c)(2)(i), the ink doesnot have an LD–50 single oral dose ofless than 500 milligrams per kilogramof body weight of the test animal; and

(iii) The cartridge does not have a ca-pacity of more than 2 grams of ink.

(8) Containers of paste shoe waxes,paste auto waxes, and paste furnitureand floor waxes containing toluene(also known as toluol), xylene (alsoknown as xylol), petroleum distillates,and/or turpentine in the concentrationsdescribed in § 1500.14(a)(3) and (5) areexempt from the labeling requirementsof § 1500.14(b)(3)(ii) and (5) if thevisicosity of such products is suffi-ciently high so that they will not flowfrom their opened containers when in-verted for 5 minutes at a temperatureof 80 °F., and are exempt from bearinga flammability warning statement ifthe flammability of such waxes is duesolely to the presence of solvents thathave flashpoints above 80 °F. whentested by the method described in§ 1500.43.

(9) Porous-tip ink-marking devicesare exempt from the labeling require-ments of section 2(p)(1) of the act (re-peated in § 1500.3(b)(14)(i)) and from thelabeling requirements of § 1500.14(b)(1),(2), and (3)(ii) and (iii) insofar as suchrequirements would be necessary be-cause the ink contained therein is atoxic substance as defined in§ 1500.3(c)(2)(i), and/or because the inkcontains 10 percent or more by weightof toluene (also known as toluol), xy-lene (also known as xylol), or petro-leum distillates as defined in§ 1500.14(a)(3), and/or because the inkcontains 10 percent or more by weightof ethylene glycol; provided that:

(i) The porous-tip ink-marking de-vices are of such construction that:

(A) The ink is held within the deviceby an absorbent material so that nofree liquid is within the device; and

(B) Under any reasonably foreseeableconditions of manipulation and use, in-cluding reasonably foreseeable abuseby children, the ink will emerge onlythrough the porous writing nib of thedevice; and

(ii)(A) The device has a capacity ofnot more than 10 grams of ink and theink, when tested by methods describedin § 1500.3(c)(2)(i), has an LD–50 singleoral dose of not less than 2.5 grams perkilogram of body weight of the testanimal; or

(B) The device has a capacity of notmore than 12 grams of ink and the ink,when tested by methods described in§ 1500.3(c)(2)(i), has an LD–50 single oraldose of not less than 3.0 grams per kilo-gram of body weight of the test animal.

(10) Viscous nitrocellulose-base adhe-sives containing more than 4 percentmethyl alcohol by weight are exemptfrom the label statement ‘‘Cannot bebe made nonpoisonous’’ required by§ 1500.14(b)(4) if:

(i) The total amount of methyl alco-hol by weight in the product does notexceed 15 percent; and

(ii) The contents of any containerdoes not exceed 2 fluid ounces.

(11) Packages containing polishing orcleaning products which consist of acarrier of solid particulate or fibrouscomposition and which contain toluene(also known as toluol), xylene (alsoknown as xylol), or petroleum dis-tillates in the concentrations describedin § 1500.14(a) (1) and (2) are exemptfrom the labeling requirements of§ 1500.14(b)(3)(ii) if such toluene, xylene,or petroleum distillate is fully ab-sorbed by the solid, semisolid, or fi-brous carrier and cannot be expressedtherefrom with any reasonably foresee-able conditions of manipulation.

(12) Containers of dry ink intended tobe used as a liquid ink after the addi-tion of water are exempt from the la-beling requirements of section 2(p)(1) ofthe act (repeated in § 1500.3(b)(14)(i))and from the labeling requirements of§ 1500.14(b) (1) and (2) insofar as such re-quirements would be necessary becausethe dried ink contained therein is atoxic substance as defined in§ 1500.3(c)(2)(i) and/or because the inkcontains 10 percent or more of ethyleneglycol as defined in § 1500.14(a)(2); pro-vided that:

(i) When tested by the method de-scribed in § 1500.3(c)(2)(i), the dry inkconcentrate does not have an LD–50 (le-thal dose, median; lethal for 50 percentor more of test group) single oral dose


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16 CFR Ch. II (1–1–97 Edition)§ 1500.83

of less than 1 gram per kilogram ofbody weight of the test animal.

(ii) The dry ink concentrate enclosedin a single container does not weighmore than 75 milligrams.

(iii) The dry ink concentrate does notcontain over 15 percent by weight ofethylene glycol.

(13) Containers of liquid and semi-solid substances such as viscous-typepaints, varnishes, lacquers, roof coat-ings, rubber vulcanizing preparations,floor covering adhesives, glazing com-pounds, and other viscous productscontaining toluene (also known as tol-uol), xylene (also known as xylol), orpetroleum distillates in concentrationsdescribed in § 1500.14(a)(3) are exemptfrom the labeling requirements of§ 1500.14(b)(3)(ii) insofar as that subdivi-sion applies to such toluene, xylene, orpetroleum distillates, provided that theviscosity of the substance or of any liq-uid that may separate or be present inthe container is not less than 100Saybolt universal seconds at 100 °F.

(14) Customer-owned portable con-tainers that are filled by retail vendorswith gasoline, kerosene (kerosine), orother petroleum distillates are exemptfrom the provision of section 2(p)(1)(A)of the act (which requires that thename and place of business of the man-ufacturer, distributor, packer, or sellerappear on the label of such containers)provided that all the other label state-ments required by section 2(p)(1) of theact and § 1500.14(b)(3) appear on the la-bels of containers of the substancesnamed in this subparagraph.

(15) Cellulose sponges are exemptfrom the labeling requirements of sec-tion 2(p)(1) of the act and § 1500.14(b)(1)insofar as such requirements would benecessary because they contain 10 per-cent or more of diethylene glycol as de-fined in § 1500.14(a)(1), provided that:

(i) The cellulose sponge does not con-tain over 15 percent by weight ofdiethylene glycol; and

(ii) The diethylene glycol content iscompletely held by the absorbent cel-lulose material so that no free liquid iswithin the sponge as marketed.

(16) Containers of substances whichinclude salt (sodium chloride) as acomponent are exempt from the label-ing requirements of section 2(p)(1) ofthe act (repeated in § 1500.3(b)(14)(i)) in-

sofar as such requirements would benecessary because the salt containedtherein is present in a quantity suffi-cient to render the article ‘‘toxic’’ asdefined in § 1500.3(3)(2)(i), provided thatthe labels of such containers bear aconspicuous statement that the prod-uct contains salt.

(17) The labeling of substances con-taining 10 percent or more of ferrousoxalate is exempt from the require-ment of § 1500.129(f) that it bear theword ‘‘poison’’ which would be requiredfor such concentration of a salt of ox-alic acid.

(18) Packages containing articles in-tended as single-use spot removers, andwhich consist of a cotton pad or otherabsorbent material saturated with amixture of drycleaning solvents, areexempt from the labeling requirementsof section 2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)) insofar as they applyto the ‘‘flammable’’ hazard as definedin § 1500.3(c)(6)(iv), provided that:

(i) The article is packaged in a sealedfoil envelope;

(ii) The total amount of solvent ineach package does not exceed 4.5 milli-liters; and

(iii) The article will ignite only whenin contact with an open flame, andwhen so ignited, the article burns witha sooty flame.

(19) Packages containing articles in-tended as single-use spot removers, andwhich consist of a cotton pad or otherabsorbent material containing methylalcohol, are exempt from the labelingrequirements of § 1500.14(b)(4), if:

(i) The total amount of cleaning sol-vent in each package does not exceed4.5 milliliters of which not more than25 percent is methyl alcohol; and

(ii) The liquid is completely held bythe absorbent materials so that no freeliquid is within the packages mar-keted.

(20) Cigarette lighters containing pe-troleum distillate fuel are exempt fromthe labeling requirements of section2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)) and § 1500.14(b)(3) inso-far as such requirements would be nec-essary because the petroleum distillatecontained therein is flammable and be-cause the substance is named in§ 1500.14(a)(3) as requiring special label-ing, provided that:


439


(i) Such lighters contain not morethan 10 cubic centimeters of fuel at thetime of sale; and

(ii) Such fuel is contained in a sealedcompartment that cannot be openedwithout the deliberate removal of theflush-set, screw-type refill plug of thelighter.

(21) Containers of dry granular fer-tilizers and dry granular plant foodsare exempt from the labeling require-ments of section 2(p)(1) of the act (re-peated in § 1500.3(b)(14)(i)) insofar assuch requirements would be necessarybecause the fertilizer or plant food con-tained therein is a toxic substance asdefined in § 1500.3(c)(2)(i), provided that:

(i) When tested by the method de-scribed in § 1500.3(c)(2)(i), the producthas a single dose LD–50 of not less than3.0 grams per kilogram of body weightof the test animal;

(ii) The label of any such exempt drygranular fertilizers discloses the iden-tity of each of the hazardous ingredi-ents;

(iii) The label bears the name and ad-dress of the manufacturer, packer, dis-tributor, or seller; and

(iv) The label bears the statement‘‘Keep out of the reach of children’’ orits practical equivalent.

(22) Small plastic capsules containinga paste composed of powdered metalsolder mixed with a liquid flux are ex-empt from the requirements of section2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)), if:

(i) The capsule holds not more thanone-half milliliter of the solder mix-ture;

(ii) The capsule is sold only as a com-ponent of a kit; and

(iii) Adequate caution statements ap-pear on the carton of the kit and onany accompanying labeling whichbears directions for use.

(23) Chemistry sets and other scienceeducation sets intended primarily foruse by juveniles, and replacement con-tainers of chemicals for such sets, areexempt from the requirements of sec-tion 2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)), if:

(i) The immediate container of eachchemical that is hazardous as definedin the act and regulations thereunderbears on its main panel the name ofsuch chemical, the appropriate signal

word for that chemical, and the addi-tional statement ‘‘Read back panel be-fore using’’ (or ‘‘Read side panel beforeusing,’’ if appropriate) and bears on theback (or side) panel of the immediatecontainer the remainder of the appro-priate cautionary statement for thespecific chemical in the container;

(ii) The experiment manual or otherinstruction book or booklet accom-panying such set bears on the frontpage thereof, as a preface to any writ-ten matter in it (or on the cover, if anythere be), the following caution state-ment within the borders of a rectangleand in the type size specified in§ 1500.121:

WARNING—This set contains chemi-cals that may be harmful if misused.Read cautions on individual containerscarefully. Not to be used by children ex-cept under adult supervision.

; and(iii) The outer carton of such set

bears on the main display panel withinthe borders of a rectangle, and in thetype size specified in § 1500.121, the cau-tion statement specified in paragraph(a)(23)(ii) of this section.

(24) Fire extinguishers containingfire extinguishing agents which arestored under pressure or which developpressure under normal conditions ofuse are exempt from the labeling re-quirements of section 2(p)(1) of the act(repeated in § 1500.3(b)(14)(i)) insofar assuch requirements apply to the pres-sure hazard as defined in § 1500.3(c)(7)(i),provided that:

(i) If the container is under pressureboth during storage and under condi-tions of use, it shall be designed towithstand a pressure of at least 6 timesthe charging pressure at 70 °F., exceptthat carbon dioxide extinguishers shallbe constructed and tested in accord-ance with applicable Interstate Com-merce Commission specifications; or

(ii) If the container is under pressureonly during conditions of use, it shallbe designed to withstand a pressure ofnot less than 5 times the maximumpressure developed under closed nozzleconditions at 70 °F. or 11⁄2 times themaximum pressure developed underclosed nozzle conditions at 120 °F.,whichever is greater.


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16 CFR Ch. II (1–1–97 Edition)§ 1500.83

(25) Cleaning and spot removing kitsintended for use in cleaning carpets,furniture, and other household objects;kits intended for use in coating, paint-ing, antiquing, and similarly process-ing furniture, furnishings, equipment,sidings, and various other surfaces; andkits intended for use in photographiccolor processing are exempt from therequirements of section 2(p)(1) of theact (repeated in § 1500.3(b)(14)(i)) andfrom the requirements of § 1500.14, pro-vided that:

(i) The immediate container of eachhazardous substance in the kit is fullylabeled and in conformance with therequirements of the act and regula-tions thereunder; and

(ii) The carton of the kit bears on themain display panel (or panels) within aborderline, and in the type size speci-fied in § 1500.121, the caution statement‘‘(Insert proper signal word as specifiedin paragraph (a)(25)(iii) of this section).This kit contains the following chemi-cals that may be harmful if misused:(List hazardous chemical componentsby name.) Read cautions on individualcontainers carefully. Keep out of thereach of children.’’

(iii) If either the word ‘‘POISON’’ or‘‘DANGER’’ is required on the con-tainer of any component of the kit, thesame word shall be required to appearas part of the caution statement on thekit carton. If both ‘‘POISON’’ and‘‘DANGER’’ are required in the label-ing of any component or components inthe kit, the word ‘‘POISON’’ shall beused. In all other cases the word‘‘WARNING’’ or ‘‘CAUTION’’ shall beused.

(26) Packages containing articles in-tended as single-use spot removers andcontaining methyl alcohol are exemptfrom the labeling specified in§ 1500.14(b)(4), if:

(i) The total amount of cleaning sol-vent in each unit does not exceed 1 mil-liliter, of which not more than 40 per-cent is methyl alcohol;

(ii) The liquid is contained in asealed glass ampoule enclosed in aplastic container with a firmly at-tached absorbent wick at one endthrough which the liquid from thecrushed ampoule must pass, under thecontemplated conditions of use; and

(iii) The labeling of each package ofthe cleaner bears the statement‘‘WARNING—Keep out of the reach ofchildren,’’ or its practical equivalent,and the name and place of business ofthe manufacturer, packer, distributor,or seller.

(27) Packaged fireworks assortmentsintended for retail distribution are ex-empt from section 2(p)(1) of the act (re-peated in § 1500.3(b)(14)(i)), if:

(i) The package contains only fire-works devices suitable for use by thepublic and designed primarily toproduce visible effects by combustion,except that small devices designed toproduce audible effects may also be in-cluded if the audible effect is producedby a charge of not more than 2 grainsof pyrotechnic composition;

(ii) Each individual article in the as-sortment is fully labeled and in con-formance with the requirements of theact and regulations thereunder; and

(iii) The outer package bears on themain display panel (or panels), withinthe borders of a rectangle and in thetype size specified in § 1500.121, the cau-tion statement ‘‘WARNING—This as-sortment contains items that may behazardous if misused and should beused only under adult supervision. IM-PORTANT—Read cautions on individ-ual items carefully.’’ (See also§ 1500.14(b)(7); § 1500.17(a) (3), (8) and (9);§ 1500.85(a)(2); and part 1507).

(28) Packages containing felt padsimpregnated with ethylene glycol areexempt from the labeling requirementsof § 1500.14(b)(1), if:

(i) The total amount of ethylene gly-col in each pad does not exceed 1 gram;and

(ii) The liquid is held by the felt padso that no free ethylene glycol is with-in the package.

(29) Cigarette lighters containing bu-tane and/or isobutane fuel are exemptfrom the labeling requirements of sec-tion 2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)) insofar as such require-ments would otherwise be necessarybecause the fuel therein is extremelyflammable and under pressure, pro-vided that:

(i) The lighters contain not morethan 12 grams of fuel at the time ofsale; and


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(ii) The fuel reservoir is designed towithstand a pressure of at least 11⁄2times the maximum pressure whichwill be developed in the container at120 °F.

(30) The outer retail containers ofsolder kits each consisting of a smalltube of flux partially surrounded by awinding of wire-type cadmium-free sil-ver solder are exempt from the labelingrequirements of section 2(p)(1) of theact (repeated in § 1500.3(b)(14)(i)), if:

(i) The metal solder contains no cad-mium and is not otherwise hazardousunder the provisions of the act;

(ii) The tube of flux in the kit is fullylabeled and in conformance with theact and regulations thereunder, andany accompanying literature thatbears directions for use also bears allthe information required by section2(p) of the act; and

(iii) The main panel of the outer con-tainer bears in type size specified in§ 1500.121 the following: (A) The signalword; (B) a statement of principal haz-ard or hazards; (C) the statement‘‘Keep out of the reach of children,’’ orits practical equivalent; and (D) in-structions to read other cautionary in-structions on the tube of flux within.

(31) Visual novelty devices consistingof sealed units, each of which unit is asteel and glass cell containing per-chloroethylene (among other things),are exempt from the requirements of§ 1500.121(a) that would otherwise re-quire a portion of the warning state-ment to appear on the glass face of thedevice, provided that:

(i) The device contains not more than105 milliliters of perchloroethylene andcontains no other component that con-tributes substantially to the hazard;and

(ii) The following cautionary state-ment appears on the device (other thanon the bottom) in the type size speci-fied in § 1500.121 (c) and (d):

CAUTION—IF BROKEN, RESULTANT VAPORS

MAY BE HARMFUL

Contains perchloroethylene. Do not exposeto extreme heat. If broken indoors, open win-dows and doors until all odor of chemical isgone.

Keep out of the reach of children.

A practical equivalent may be sub-stituted for the statement ‘‘Keep out ofthe reach of children.’’

(32) Hollow plastic toys containingmineral oil are exempt from the label-ing specified in § 1500.14(b)(3)(ii), if:

(i) The article contains no other in-gredient that would cause it to possessthe aspiration hazard specified in§ 1500.14(b)(3)(ii);

(ii) The article contains not morethan 6 fluid ounces of mineral oil;

(iii) The mineral oil has a viscosityof at least 70 Saybolt universal secondsat 100 °F.;

(iv) The mineral oil meets the speci-fications in the N.F. for light liquidpetrolatum; and

(v) The container bears the state-ment ‘‘CAUTION—Contains light liquidpetrolatum N.F. Discard if broken orleak develops.’’

(33) Containers of mineral oil havinga capacity of not more than 1 fluidounce and intended for use in produc-ing a smoke effect for toy trains areexempt from the labeling specified in§ 1500.14(b)(3), if:

(i) The mineral oil meets the speci-fications in the N.F. for light liquidpetrolatum;

(ii) The mineral oil has a viscosity ofat least 130 Saybolt universal secondsat 100 °F.;

(iii) The article contains no other in-gredient that contributes to the haz-ard; and

(iv) The label declares the presencelight liquid petrolatum and the nameand place of business of the manufac-turer, packer, distributor, or seller.

(34) Viscous products containingmore than 4 percent by weight of meth-yl alcohol, such as adhesives, asphalt-base roof and tank coatings, and simi-lar products, are exempt from bearingthe special labeling required by§ 1500.14(b)(4), if:

(i) The product contains not morethan 15 percent by weight of methyl al-cohol;

(ii) The methyl alcohol does not sepa-rate from the other ingredients uponstanding or through any foreseeableuse or manipulation;

(iii) The viscosity of the product isnot less than 7,000 centipoises at 77 °F.,unless the product is packaged in a


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pressurized container and is dispensedas a liquid unsuitable for drinking; and

(iv) The labeling bears the statement‘‘Contains methyl alcohol. Use only inwell-ventilated area. Keep out of thereach of children.’’

(35) Individual blasting caps are ex-empt from bearing the statement‘‘Keep out of the reach of children,’’ orits practical equivalent, if:

(i) Each cap bears conspicuously inthe largest type size practicable thestatement ‘‘DANGEROUS—BLASTINGCAPS—EXPLOSIVE’’; and

(ii) The outer carton and any accom-panying printed matter bear appro-priate, complete cautionary labeling.

(36) Individual toy rocket propellantdevices and separate delay train and/orrecovery system activation devices in-tended for use with premanufacturedmodel rocket engines are exempt frombearing the full labeling required bysection 2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i)) insofar as such require-ments would be necessary because thearticles are flammable or generatepressure, provided that:

(i) The devices are designed and con-structed in accordance with the speci-fications in § 1500.85(a) (8) or (9):

(ii) Each individual device or retailpackage of devices bears the following:

(A) The statement ‘‘WARNING—FLAMMABLE: Read instructions be-fore use’’;

(B) The common or usual name of thearticle;

(C) A statement of the type of engineand 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 dis-tributed to users is accompanied by aninstruction sheet bearing completecautionary labeling and instructionsfor safe use and handling of the individ-ual rocket engines.

(37) Glues with a cyanoacrylate basein packages containing 3 grams or lessare exempt from the requirement of§ 1500.121(d) that labeling which is per-mitted to appear elsewhere than on themain label panel must be in type sizeno smaller than 6 point type, providedthat:

(i) The main panel of the immediatecontainer bears both the proper signalword and a statement of the principalhazard or hazards associated with thisproduct, as provided by § 1500.121 (a)and (c);

(ii) The main panel of the immediatecontainer also bears an instruction toread carefully additional warningselsewhere on the label and on anyouter package, accompanying leaflet,and display card. The instruction toread additional warnings must complywith the size, placement, conspicuous-ness, and contrast requirements of§ 1500.121; and

(iii) The remainder of the cautionarylabeling required by the act that is noton the main label panel must appearelsewhere on the label in legible typeand must appear on any outer package,accompanying leaflet, and displaycard. If there is no outer package, ac-companying leaflet, or display card,then the remainder of the required cau-tionary labeling must be displayed on atag or other suitable material that issecurely affixed to the article so thatthe labeling will remain attachedthroughout the conditions of mer-chandising and distribution to the ulti-mate consumer. That labeling whichmust appear on any outer package, ac-companying leaflet, tag, or other suit-able material must comply with thesize, placement, contrast, and con-spicuousness requirements of§ 1500.121(d).

(38) Rigid or semi-rigid writing in-struments and ink cartridges having awriting point and an ink reservoir areexempt from the labeling requirementsof section 2(p)(1) of the act (repeated in§ 1500.3(b)(14)(i) of the regulations) andof regulations issued under section 3(b)of the act (§ 1500.14(b)(1, 2)) insofar assuch requirements would be necessarybecause the ink contained therein is a‘‘toxic’’ substance as defined in§ 1500.3(c)(2)(i) and/or because the inkcontains 10 percent or more by weightethylene glycol or diethylene glycol, ifall the following conditions are met:

(i) The writing instrument or car-tridge is of such construction that theink will, under any reasonably foresee-able condition of manipulation and use,emerge only from the writing tip.


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(ii) When tested by the method de-scribed in § 1500.3(c)(2)(i), the ink doesnot have an LD–50 single oral dose ofless than 2.5 grams per kilogram ofbody weight of the test animal.

(iii) If the ink contains ethylene gly-col or diethylene glycol, the amount ofsuch substance, either singly or incombination, does not exceed 1 gramper writing instrument or cartridge.

(iv) The amount of ink in the writinginstrument or cartridge does not ex-ceed 3 grams.

[38 FR 27012, Sept. 27, 1973; 42 FR 33026, June29, 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 FR16, Jan. 3, 1983]

§ 1500.85 Exemptions from classifica-tion as banned hazardous sub-stances.

(a) The term banned hazardous sub-stances as used in section 2(q)(1)(A) ofthe act shall not apply to the followingarticles provided that these articlesbear labeling giving adequate direc-tions and warnings for safe use:

(1) Chemistry sets and other scienceeducation sets intended primarily forjuveniles, and replacement componentsfor such sets, when labeled in accord-ance with § 1500.83(a)(23).

(2) Firecrackers designed to produceaudible effects, if the audible effect isproduced by a charge of not more than50 milligrams (.772 grains) of pyro-technic composition. (See also§ 1500.14(b)(7); § 1500.17(a) (3), (8) and (9);and part 1507).

(3) [Reserved](4) Educational materials such as art

materials, preserved biological speci-mens, laboratory chemicals, and otherarticles intended and used for edu-cational purposes.

(5) Liquid fuels containing more than4 percent by weight of methyl alcoholthat are intended and used for oper-ation of miniature engines for modelairplanes, boats, cars, etc.

(6) Novelties consisting of a mixtureof polyvinyl acetate, U.S. Certified Col-ors, and not more than 25 percent byweight of acetone, and intended forblowing plastic balloons.

(7) Games containing, as the sole haz-ardous component, a self-pressurizedcontainer of soap solution or similar

foam-generating mixture provided thatthe foam-generating component has nohazards other than being in a self-pres-surized container.

(8) Model rocket propellant devicesdesigned for use in light-weight, recov-erable, and reflyable model rockets,provided such devices:

(i) Are designed to be ignited by elec-trical means.

(ii) Contain no more than 62.5 grams(2.2 ounces) of propellant material andproduce less than 80 newton-seconds(17.92 pound seconds) of total impulsewith thrust duration not less than 0.050second.

(iii) Are constructed such that all thechemical ingredients are preloadedinto a cylindrical paper or similarlyconstructed nonmetallic tube that willnot fragment into sharp, hard pieces.

(iv) Are designed so that they willnot burst under normal conditions ofuse, are incapable of spontaneous igni-tion, and do not contain any type of ex-plosive or pyrotechnic warhead otherthan a small parachute or recovery-system activation charge.

(9) Separate delay train and/or recov-ery system activation devices intendedfor use with premanufactured modelrocket engines wherein all of the chem-ical ingredients are preloaded so theuser does not handle any chemical in-gredient and are so designed that themain casing or container does not rup-ture during operation.

(10) Solid fuel pellets intended for usein miniature jet engines for propellingmodel jet airplanes, speed boats, racingcars, and similar models, provided suchsolid fuel pellets:

(i) Weigh not more than 11.5 gramseach.

(ii) Are coated with a protective res-inous film.

(iii) Contain not more than 35 per-cent potassium dichromate.

(iv) Produce a maximum thrust ofnot more than 71⁄2 ounces when used asdirected.

(v) Burn not longer than 12 secondseach when used as directed.

(11) Fuses intended for igniting fuelpellets exempt under subparagraph (10)of this paragraph.

(12) Kits intended for construction ofmodel rockets and jet propelled modelairplanes requiring the use of


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difluorodichloromethane as a propel-lant, provided the outer carton bearson the main panel in conspicuous typesize the statement ‘‘WARNING—Care-fully read instructions and cautions be-fore use.’’

(13) Flammable wire materials in-tended for electro-mechanical actu-ation and release devices for modelkits described in paragraph (12) of thissection, provided each wire does not ex-ceed 15 milligrams in weight.

[38 FR 27012, Sept. 27, 1973, as amended at 41FR 22935, June 8, 1976; 42 FR 43391, Aug. 29,1977; 48 FR 16, Jan. 3, 1983]

§ 1500.86 Exemptions from classifica-tion as a banned toy or otherbanned article for use by children.

(a) The term banned hazardous sub-stance as used in section 2(q)(1)(A) ofthe act (repeated in § 1500.3(b)(15)(i)(A))of the act shall not apply to the follow-ing articles:

(1) Toy rattles described in§ 1500.18(a)(1) in which the rigid wires,sharp protrusions, or loose small ob-jects are internal and provided thatsuch rattles are constructed so thatthey will not break or deform to exposeor release the contents either in nor-mal use or when subjected to reason-ably foreseeable damage or abuse.

(2) Dolls and stuffed animals andother similar toys described in§ 1500.18(a)(3) in which the componentsthat have the potential for causing lac-eration, puncture wound injury, orother similar injury are internal, pro-vided such dolls, stuffed animals, andother similar toys are constructed sothat they will not break or deform toexpose such components either in nor-mal use or when subjected to reason-ably foreseeable damage or abuse.

(3) [Reserved](4) Any article known as a ‘‘baby-

bouncer,’’ ‘‘walker-jumper,’’ or ‘‘baby-walker’’ and any other similar article(referred to in this paragraph as ‘‘arti-cle(s)’’) described in § 1500.18(a)(6) pro-vided:

(i) The frames are designed and con-structed in a manner to prevent injuryfrom any scissoring, shearing, or pinch-ing when the members of the frame orother components rotate about a com-mon axis or fastening point or other-wise move relative to one another; and

(ii) Any coil springs which expandwhen the article is subjected to a forcethat will extend the spring to its maxi-mum distance so that a space betweensuccessive coils is greater than one-eighth inch (0.125 inch) are covered orotherwise designed to prevent injuries;and

(iii) All holes larger than one-eighthinch (0.125 inch) in diameter and slots,cracks, or hinged components in anyportion of the article through which achild could insert, in whole or in part afinger, toe, or any other part of theanatomy are guarded or otherwise de-signed to prevent injuries; and

(iv) The articles are designed andconstructed to prevent accidental col-lapse while in use; and

(v) The articles are designed and con-structed in a manner that eliminatesfrom any portion of the article the pos-sibility of presenting a mechanical haz-ard through pinching, bruising, lac-erating, crushing, breaking, amputat-ing, or otherwise injuring portions ofthe human body when in normal use orwhen subjected to reasonably foresee-able damage or abuse; and

(vi) Any article which is introducedinto interstate commerce after the ef-fective date of this subparagraph is la-beled:

(A) With a conspicuous statement ofthe name and address of the manufac-turer, packer, distributor, or seller;and

(B) With a code mark on the articleitself and on the package containingthe article or on the shipping con-tainer, in addition to the invoice(s) orshipping document(s), which code markwill permit future identification by themanufacturer of any given model (themanufacturer shall change the modelnumber whenever the article undergoesa significant structural or design modi-fication); and

(vii) The manufacturer or importer ofthe article shall make, keep, and main-tain for 3 years records of sale, dis-tribution, and results of inspectionsand tests conducted in accordance withthis subparagraph and shall make suchrecords available at all reasonablehours upon request by any officer oremployee of the Consumer ProductSafety Commission and shall permitsuch officer or employee to inspect and


445


copy such records, to make such stockinventories as he deems necessary, andto otherwise check the correctness ofsuch records.

(5) Clacker balls described in§ 1500.18(a)(7) that have been designed,manufactured, assembled, labeled, andtested in accordance with the followingrequirements, and when tested at thepoint of production or while in inter-state commerce or while held for saleafter shipment in interstate commercedo not exceed the failure rate require-ments of the table in paragraph(a)(5)(vi) of this section:

(i) The toy shall be so designed andfabricated that:

(A) Each ball: Weighs less than 50grams; will not shatter, crack, or chip;is free of cracks, flash (ridges due toimperfect molding), and crazing (tinysurface cracks); and is free of rough orsharp edges around any hole where thecord enters or over any surface withwhich the cord may make contact.Each ball is free of internal voids(holes, cavities, or air bubbles) if theballs are made of materials other thanthose materials (such as ABS (acrylo-nitrile butadiene styrene), nylon, andhigh-impact polystyrene) that are in-jection-molded and possess high-im-pact characteristics.

(B) The cord: Is of high tensilestrength, synthetic fibers that arebraided or woven, having a breakingstrength in excess of 445 Newtons (100pounds); is free of fraying or any otherdefect that might tend to reduce itsstrength in use; is not molded in ballsmade of casting resins which tend towick up or run up on the outside of thecord; and is affixed to a ball at the cen-ter of the horizontal plane of the ballwhen it is suspended by the cord.Clacker balls where the mass of eachball is less than 12 grams (0.42 oz.) andthe distance between the center of thepivot and the center of the ball cannotexceed 180 mm (7.1 inches) may have aminimum cord breaking strength ofless than 445 Newtons (100 pounds), ascomputed by the following formula:

Adjusted Cord Breaking Strength inNewtons=0.1382(mb) (Rp), where mb=mass of asingle ball in grams and

Rp=pivot length in mm.

(C) When the cord is attached to theball by means of a knot, the end be-

neath the knot is chemically fused orotherwise treated to prevent the knotfrom slipping out or untying in use.

(ii) The toy shall be tested at thetime of production:

(A) By using the sampling proceduredescribed in the table in subdivision(vi) of this subparagraph to determinethe number of units to be tested.

(B) By subjecting each ball tested to10 drops of a 2.25 kg (5-pound) steel im-pact rod or weight (57-mm (21⁄4-inch) di-ameter with a flat head) dropped 1220mm (48 inches) in a vented steel or alu-minum tube (60-mm (23⁄8-inch) insidediameter) when the ball is placed on asteel or cast iron mount. Clacker ballswhere the mass of each ball is less than12 grams (0.42 oz.) and the distance be-tween the center of the pivot and thecenter of the ball cannot exceed 180mm (7.1 inches) may be tested by drop-ping the impact weight from a heightof less than 1220 mm (48 in.), where theheight is computed as follows:

Adjusted drop height in mm=179×10¥5(mb)(Rp2), where mb=mass of a single ball ingrams and

Rp=pivot length in mm.

Any ball showing any chipping, crack-ing, or shattering shall be counted as afailure within the meaning of the thirdcolumn of the table in paragraph(a)(5)(vi) of this section.

(C) By inspecting each ball tested forsmoothness of finish on any surface ofthe ball which may come in contactwith the cord during use. A cottonswab shall be rubbed vigorously overeach such surface or area of the ball; ifany cotton fibers are removed, the ballshall be counted as a failure within themeaning of the fourth column of thetable in subdivision (vi) of this para-graph. The toy shall also be checked toascertain that there is no visibly per-ceptible ‘‘wicking up’’ or ‘‘running up’’of the casting resins on the outside ofthe cord in the vicinity where the ballis attached.

(D) By fully assembling the toy andtesting the cord in such a manner as totest both the strength of the cord andthe adequacy with which the cord is at-tached to the ball and any holding de-vice such as a tab or ring included inthe assembly. The fully assembled arti-cle shall be vertically suspended by oneball and a 445-Newton (100-pound) test


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applied to the bottom ball. Clackerballs where the mass of each ball is lessthan 12 grams (0.42 oz.) and the dis-tance between the center of the pivotand the center of the ball cannot ex-ceed 180 mm (7.1 inches) may be testedwith a force of under 445 Newtons (100pounds). The test force for these clack-er balls shall be the same as the cordbreaking strength calculated in§ 1500.86(a)(5)(i)(B). Any breaking, fray-ing, or unraveling of the cord or anysign of slipping, loosening, or unfasten-ing shall be counted as a failure withinthe meaning of the fourth column ofthe table in paragraph (a)(5)(vi) of thissection.

(E) By additionally subjecting anyring or other holding device to a 222-Newton (50-pound) test load applied toboth cords; the holding device is to besecurely fixed horizontally in a suit-able clamp in such a manner as to sup-port 50 percent of the area of such hold-ing device and the balls are suspendedfreely. Clacker balls where the mass ofeach ball is less than 12 grams (0.42 oz.)and the distance between the center ofthe pivot and the center of the ballcannot exceed 180 mm (7.1 inches) mayhave their holding device tested with aforce of less than 222 Newtons (50pounds). The holding device test forcefor these clacker balls shall be half ofthe cord breaking strength calculatedin § 1500.86(a)(5)(i)(B). Any breaking,cracking, or crazing of the ring orother holding device shall be countedas a failure within the meaning of thefourth column of the table in para-graph (a)(5)(vi) of this section.

(F) By cutting each ball tested inhalf and then cutting each half per-pendicularly to the first cut into threeor more pieces of approximately equalthickness. Each portion is to be in-spected before and after cutting, andany ball showing any flash, crack, craz-ing, or internal voids on such inspec-tion is to be counted as a failure withinthe meaning of the fourth column ofthe table in paragraph (a)(5)(vi) of thissection. Balls that are injection-mold-ed and possess high-impact characteris-tics (such as injection-molded ballsmade of ABS, nylon, or high-impactpolystyrene) though exempt from therequirements that there be no internalvoids, must be tested to determine the

presence of any flash, crack or grazing.A transparent ball shall be subjected tothe same requirements except that itmay be visually inspected without cut-ting.

(iii) The toy shall be fully assembledfor use at time of sale, including theproper attachments of balls, cords,knots, loops, or other holding devices.

(iv) The toy shall be labeled:(A) With a conspicuous statement of

the name and address of the manufac-turer, packer, distributor, or seller.

(B) To bear on the toy itself and/orthe package containing the toy and/orthe shipping container, in addition tothe invoice(s) and shipping docu-ment(s), a code or mark in a form andmanner that will permit future identi-fication of any given batch, lot, orshipment by the manufacturer.

(C) To bear a conspicuous warningstatement on the main panel of the re-tail container and display carton andon any accompanying literature: Thatif cracks develop in a ball or if the cordbecomes frayed or loose or unfastened,use of the toy should be discontinued;and if a ring or loop or other holdingdevice is present, the statement ‘‘Inuse, the ring or loop must be placedaround the middle finger and the twocords positioned over the forefingerand held securely between the thumband forefinger,’’ or words to that effectwhich will provide adequate instruc-tions and warnings to prevent the hold-ing device from accidentally slippingout of the hand. Such statements shallbe printed in sharply contrasting colorwithin a borderline and in letters atleast 6 mm (1⁄4 inch) high on the mainpanel of the container and at least 3mm (1⁄8) high on all accompanying lit-erature.

(v) The manufacturer of the toy shallmake, keep, and maintain for 3 yearsrecords of sale, distribution, and re-sults of inspections and tests con-ducted in accordance with this sub-paragraph and shall make such recordsavailable upon request at all reason-able hours by any officer or employeeof the Consumer Product Safety Com-mission, and shall permit such officeror employee to inspect and copy suchrecords and to make such inventoriesof stock as he deems necessary and


447


otherwise to check the correctness ofsuch records.

(vi) The lot size, sample size, andfailure rate for testing clacker ballsare as follows:

Number of units in batch, shipment, deliv-ery, lot, or retail stock

Number of units in ran-dom sample

Failure rate constitutingrejection when testing per

§ 1500.86(a)(5)(ii)(B)

Failure rate constitutingrejection when testing per

§ 1500.86(a)(5)(ii) (C),(D), (E), and (F)

50 or less ..................................................... 8 1 151 to 90 ....................................................... 13 1 191 to 150 ..................................................... 20 1 1151 to 280 ................................................... 32 1 2281 to 500 ................................................... 50 1 2501 to 1,200 ................................................ 80 2 41,201 to 3,200 ............................................. 125 2 63,201 to 10,000 ........................................... 200 3 1010,001 to 35,000 ......................................... 315 4 1635,001 to 150,000 ....................................... 500 6 25150,001 to 500,000 ..................................... 800 8 40500,001 and over ........................................ 1,250 11 62

(vii) Applicability of the exemptionprovided by this paragraph shall be de-termined through use of the table inparagraph (a)(5)(vi) of this section. Arandom sample of the number of arti-cles as specified in the second columnof the table shall be selected accordingto the number of articles in a particu-lar batch, shipment, delivery, lot, orretail stock per the first column. Afailure rate as shown in either thethird or fourth column shall indicatethat the entire batch, shipment, deliv-ery, lot, or retail stock has failed andthus is not exempted under this para-graph from classification as a bannedhazardous substance.

(6) Caps (paper or plastic) describedin § 1500.18(a)(5), provided:

(i) Such articles do not produce peaksound pressure levels greater than 158decibels when tested in accordancewith § 1500.47, and provided any such ar-ticles producing peak sound pressurelevels greater than 138 decibels but notgreater than 158 decibels when testedin accordance with § 1500.47 shall bearthe following statement on the cartonand in the accompanying literature inaccordance with § 1500.121: ‘‘WARN-ING—Do not fire closer than 1 foot tothe ear. Do not use indoors.’’

(ii) Any person who elects to distrib-ute toy caps in accordance with para-graph (a)(6)(i) of this section shallpromptly notify the Consumer ProductSafety Commission, Bureau of Compli-ance, Washington, D.C. 20207, of theirintention and shall conduct or partici-pate in a program to develop caps that

produce a sound pressure level of notmore than 138 decibels when tested inaccordance with § 1500.47.

(iii) Any person who elects to distrib-ute caps in accordance with paragraph(a)(6)(i) of this section shall, after noti-fication of his intentions to the Com-mission in accordance with paragraph(a)(6)(ii) of this section, submit to theConsumer Product Safety Commission,Bureau of Compliance, Washington, DC20207, a progress report not less fre-quently than once every 3 months con-cerning the status of his program todevelop caps that produce a sound levelof not more than 138 decibels whentested in accordance with § 1500.47.

[38 FR 27012, Sept. 27, 1973, as amended at 53FR 46839, Nov. 18, 1988; 59 FR 9076, 9077, Feb.25, 1994]

§ 1500.121 Labeling requirements;prominence, placement, and con-spicuousness.

(a)(1) Background and scope. Section2(p)(1) of the Federal Hazardous Sub-stances Act (FHSA) or ‘‘the Act’’), 15U.S.C. 1261(p)(1), requires that hazard-ous substances bear certain cautionarystatements on their labels. Thesestatements include: signal words; af-firmative statements of the principalhazard(s) associated with a hazardoussubstance; the common or usual name,or chemical name, of the hazardoussubstance; the name and place of busi-ness of the manufacturer, packer, dis-tributor, or seller; statements of pre-cautionary measures to follow; instruc-tions, when appropriate, for special


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16 CFR Ch. II (1–1–97 Edition)§ 1500.121

handling and storage; the statement‘‘Keep Out of the Reach of Children’’ orits practical equivalent; and, when ap-propriate, first-aid instructions. Sec-tion 2(p)(2) of the Act specifies that allsuch statements shall be locatedprominently on the label of such a sub-stance and shall appear in conspicuousand legible type in contrast by typog-raphy, layout, or color with otherprinted matter on the label. This regu-lation contains the Commission’s in-terpretations and policies for the typesize and placement of cautionary mate-rial on the labels of hazardous sub-stances and contains other criteria forsuch cautionary statements that areacceptable to the Commission as satis-fying section 2(p)(2) of the Act. Labelsthat do not comply with this regula-tion may be considered misbranded.

(2) Definitions. For the purposes ofthis section:

(i) Container means the immediatepackage from which a hazardous sub-stance may be dispensed and also anyarticle, package or wrapping, such as atube or cone used for a firework or awet cell battery casing containing sul-furic acid, which is necessary for thesubstance to function during actualuse.

(ii) Cautionary material, cautionary la-beling, and cautionary labeling requiredby the Act mean all items of labelinginformation required by sections 2(p)(1)of the FHSA (repeated in 16 CFR1500.3(b)(14)(i) or by the regulationswhich require additional labeling undersection 3(b) of the Act.

(iii) Display panel means any surfaceof the immediate container, and of anyouter container or wrapping, whichbears labeling.

(iv) Principal display panel means theportion(s) of the surface of the imme-diate container, and of any outer con-tainer or wrapping, which bear(s) thelabeling designed to be most promi-nently displayed, shown, presented, orexamined under conditions of retailsale. (See paragraph (c)(1) of this sec-tion.)

(v) Type size means the actual heightof the printed image of each upper caseor capital letter as it appears on thelabel of a hazardous substance. (Seeparagraph (c)(2) of this section.)

(vi) Signal word means the appro-priate word ‘‘DANGER,’’ ‘‘WARNING,’’or ‘‘CAUTION,’’ as required by sections2(p)(1) (C) or (D) of the Act.

(vii) Statement of principal hazard(s)means that wording descriptive of theprincipal or primary hazard(s) associ-ated with a hazardous substance re-quired by section 2(p)(1)(E) of the Act.Some examples of such statements are‘‘HARMFUL OR FATAL IF SWAL-LOWED,’’ ‘‘VAPOR HARMFUL,’’‘‘FLAMMABLE,’’ and ‘‘SKIN AND EYEIRRITANT.’’

(viii) Other cautionary material meansall labeling statements, other than‘‘signal words’’ or ‘‘statement(s) ofprincipal hazard(s),’’ required by theAct or by regulations issued under theAct.

(b) Prominent label placement. To sat-isfy the requirement of the Act thatcautionary labeling statements shallappear ‘‘prominently’’ on the label of ahazardous substance, all such state-ments shall be placed on the label asfollows:

(1) Horizontal placement of labelingstatements. Except for the name andplace of business of the manufacturer,packer, distributor, or seller, all cau-tionary material required by the Actshall appear in lines that are generallyparallel to any base on which the pack-age rests as it is designed to be dis-played for sale or, on display panelsother than the principal display panel,in lines generally parallel to all otherlabeling on that panel. This require-ment does not apply to labeling on col-lapsible tubes, cylindrical containerswith a narrow diameter, or F-type con-tainers where both the ‘‘front’’ and‘‘back’’ of the container are principaldisplay panels. (See paragraph (e) ofthis section.)

(2) Principal display panel labeling. (i)All items of cautionary labeling re-quired by the Act may appear on theprincipal display panel on the imme-diate container and, if appropriate, onany other container or wrapper. Seeparagraph (b)(4) of this section for re-quirements and exceptions for labelingouter containers and wrappings.

(ii) The signal word, the statement ofprincipal hazard(s), and, if appropriate,instructions to read carefully any cau-tionary material that may be placed


449


elsewhere on the label shall be blockedtogether within a square or rectangu-lar area, with or without a border, onthe principal display panel on the im-mediate container and, where requiredby paragraph (b)(4) of this section, onany outer container or wrapping. Allcautionary statements placed on theprincipal display panel shall be sepa-rated on all sides from other printed orgraphic matter, with the exception ofthe declaration of net contents re-quired under the Fair Packaging andLabeling Act, 15 U.S.C. 1453(a) (2) and(3), by a border line or by a space nosmaller than the minimum allowableheight of the type size for cautionarymaterial required by the Act (exclusiveof signal words and statements of haz-ard) on the principal display panel.

(iii) Depending on the design of thepackage or the configuration of thelabel, or both, a package may havemore than one principal display panel.If so, each principal display panel mustbear, at a minimum, the signal word,statement of principal hazard or haz-ards, and, if appropriate, instructionsto read carefully any cautionary mate-rial that may be placed elsewhere onthe label.

(A) Where the principal display panelof the immediate container consists ofa lid, cap, or other item which may beseparated from the immediate con-tainer and discarded, the containershall be deemed to have a second prin-cipal display panel elsewhere on theimmediate container which must bear,at a minimum, the signal word, state-ment of principal hazard(s), and in-structions, if appropriate, to read anycautionary material which may beplaced elsewhere on the label.

(3) Prominent label placement—otherdisplay panel labeling. All items of cau-tionary labeling required by the Actwhich do not appear on the principaldisplay panel shall be placed togetheron a display panel elsewhere on thecontainer. The name and place of busi-ness of the manufacturer, packer, dis-tributor, or seller may appear sepa-rately on any display panel. Where cau-tionary material appears on a displaypanel other than the principal displaypanel, the principal display panel shallbear the statement ‘‘Read carefullyother cautions on the lll panel,’’ or

its practical equivalent. [A descriptionof the location of the other panel is tobe inserted in the blank space.]

(4) Outer container or wrappings. Allcautionary labeling appearing on theimmediate container of a hazardoussubstance shall also appear on anyouter container or wrapping used inthe retail display of the substance, inthe same manner as required for theimmediate container. Those caution-ary labeling statements appearing onthe immediate container which areclearly legible through any outer con-tainer or wrapper used in retail displayneed not appear on the outer containeror wrapping itself. (See section 2(n)(1)of the Act.)

(5) Placement of the word ‘‘Poison’’ andthe skull and crossbones symbol. Theword ‘‘poison’’ and, when appropriate,the skull and crossbones symbol shallappear on the label of a hazardous sub-stance as follows:

(i) If a hazardous substance is ‘‘high-ly toxic,’’ as defined in § 1500.3(c)(i) andsection 2(h)(1) of the FHSA, the labelmust bear the word ‘‘poison’’ in accord-ance with section 2(p)(1)(H) of the Act,in addition to the signal word ‘‘DAN-GER,’’ and must also bear the skulland crossbones symbol. Some products,under § 1500.14(b) of the regulations,may, in addition to any required signalword, be required to bear the word‘‘poison’’ and the skull and crossbonessymbol because of the special hazardassociated with their ingredients. Inboth instances, the word ‘‘poison’’ andthe skull and crossbones symbol neednot appear on the principal displaypanel on the container, unless all othercautionary labeling required by theAct appears on the principal displaypanel. The word ‘‘poison’’ and the skulland crossbones symbol, when required,must appear either together with othercautionary labeling on a display panelother than the principal display panelor together with the signal word andstatement(s) of principal hazard on theprincipal display panel.

(ii) Where, pursuant to a regulationissued under section 3(b) of the Act, thelabel of a hazardous substance requiresthe word ‘‘poison’’ instead of a signalword, the word, ‘‘POISON’’ shall appear


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in capital letters on the principal dis-play panel, together with the state-ment(s) of the principal hazard. Certainsubstances for which the word ‘‘poi-son’’ is required instead of any signalword are listed in § 1500.129.

(c) Conspicuousness—type size andstyle. To satisfy the requirement thatcautionary labeling statements underthe Act be conspicuous and legible,such statements shall conform to thefollowing requirements:

(1) Area of principal display panel. Thearea of the principal display panel isthe area of the side or surface of theimmediate container, or of the side orsurface of any outer container or wrap-ping, that bears the labeling designedto be most prominently displayed,shown, presented, or examined underconditions of retail sale. This area isnot limited to the portion of the sur-face covered with labeling; rather, itincludes the entire surface. Flanges atthe tops and bottoms of cans, conicalshoulders of cans, handles, and shoul-ders and necks of bottles and jars areexcluded in measuring the area. Forthe purposes of determining the propertype size for cautionary labeling, thearea of the principal display panel (orother panel bearing cautionary label-ing, under paragraph (c)(2)(ii) of thissection) is to be computed as follows:

(i) In the case of a rectangular pack-age, where one entire side is the prin-cipal display panel, the product of theheight times the width of that sideshall be the area of the principal dis-play panel.

(ii) In the case of a cylindrical ornearly cylindrical container or tube onwhich the principal display panel ap-

pears on the side, the area of the prin-cipal display panel shall be 40 percentof the product of the height of the con-tainer times its circumference.

(iii) In the case of any other shape ofcontainer, the area of the principal dis-play panel shall be 40 percent of thetotal surface of the container, exclud-ing those areas, such as flanges at topsand bottoms, specified in paragraph(c)(1) above. However, if such a con-tainer presents an obvious principaldisplay panel (such as an oval or hour-glass shaped area on the side of a con-tainer for dishwashing detergent), thearea to be measured shall be the entirearea of the obvious principal displaypanel.

(2) Type-size requirements. (i) The termtype size refers to the height of the ac-tual printed image of each upper caseor capital letter as it appears on thelabel. The size of cautionary labelingshall be reasonably related to the typesize of any other printing appearing onthe same panel, but in any case mustmeet the minimum size requirementsin Table 1.

(ii) When an item of labeling is re-quired to be in a specified type size, allupper case, or capital, letters must beat least equal in height to the requiredtype size, and all other letters must bethe same style as the upper case orcapital letters. Unless otherwise speci-fied in the regulations (examples ap-pear at §§ 1500.14(b)(6), 1512.19, 1508.9,and part 1505), the type size of all cau-tionary statements appearing on anydisplay panel shall comply with thespecifications in Table 1 when the areaof the display panel is measured by themethod in paragraph (c)(1) above:

TABLE IArea of principal display panel in square inches ............ 0–2 >2–5 >5–10 >10–15 >15–30 >30Type size in inches!* ....................................................... ........ .......... ............ .............. .............. ........

Signal word ** .......................................................... 3⁄64 1⁄16 3⁄32 7⁄64 1⁄8 5⁄32

Statement of hazard ................................................. 3⁄64 3⁄64 1⁄16 3⁄32 3⁄32 7⁄64

Other cautionary material*** .................................... 1⁄32 3⁄64 1⁄16 1⁄16 5⁄64 3⁄32

> means ‘‘greater than.’’* minimum height of printed image of capital or upper case letters.** including the word ‘‘poison’’ when required instead of a signal word by Section 3(b) of the Act (§ 1500.129).*** size of lettering for other cautionary material is based on the area of the display panel on which such cautionary material

appears.

(iii) If all of the required cautionarylabeling does not appear on the prin-cipal display panel, the statement to

‘‘Read carefully other cautions on thelll panel,’’ or its practical equiva-lent, must appear in, as a minimum,


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the same type size as that required inTable 1 for the other cautionary mate-rial which appears elsewhere on thelabel of a hazardous substance. The sizeof the cautionary labeling that doesnot appear on the principal displaypanel is determined by the area of thepanel on which it does appear.

(3) Type style—proportion. The ratio ofthe height of a capital or uppercase let-ter to its width shall be such that theheight of the letter is no more than 3times its width.

(4) Signal word and statements of haz-ard—capital letters. The signal word, theword ‘‘poison’’ if required instead of asignal word (see § 1500.129), and thestatement of principal hazard or haz-ards shall be in capital letters.

(5) Multiple statement of hazard—typesize and style. All statements of prin-cipal hazard or hazards on a label shallappear in the same size and style oftype, and shall appear in the samecolor or have the same degree of bold-ness.

(6) Accompanying literature containingdirections for use. Where literature ac-companying the package of a hazard-ous substance has directions for use,written or otherwise, section 2(n) ofthe Act requires the literature to bearcautionary labeling.

(i) All such cautionary labeling shallbe in reasonable proximity to any di-rection for use and shall be placed to-gether within the same general area.

(ii) The type size of such cautionarylabeling shall be reasonably related tothe type size of any other printed mat-ter in the accompanying literature andmust be in conspicuous and legibletype by typography, layout, or colorwith other printed matter on the label.The signal word and statement of prin-cipal hazard or hazards shall appear incapital letters.

(d) Conspicuousness—contrast. To sat-isfy the requirement that cautionarylabeling statements appear in con-spicuous and legible type which is incontrast by typography, layout, orcolor with the other printed matter onthe label, such statements shall con-form to the following requirements:

(1) Color. Where color is the primarymethod used to achieve appropriatecontrast, the color of any cautionarylabeling statement shall be in sharp

contrast with the color of the back-ground upon which such a statementappears. Examples of combinations ofcolors which may not satisfy the re-quirement for sharp contrast are: blackletters on a dark blue or dark greenbackground, dark red letters on a lightred background, light red letters on areflective silver background, and whiteletters on a light gray or tan back-ground.

(2) Interference with conspicuousness—labeling design, vignettes, or other printedmaterial. For cautionary informationappearing on panels other than theprincipal display panel, the label de-sign, the use of vignettes, or the prox-imity of other labeling or letteringshall not be such that any cautionarylabeling statement is obscured or ren-dered inconspicuous.

(e) Collapsible metal tubes. Collapsiblemetal tubes containing hazardous sub-stances shall be labeled so that all cau-tionary labeling required by the Actappears as close to the dispensing endof the container as possible. The place-ment and conspicuousness of thesestatements shall conform to the provi-sions of paragraphs (b), (c), and (d) ofthis section.

(f) Unpackaged hazardous substances.Where practicable, unpackaged hazard-ous substances intended, or distributedin a form suitable, for use in or arounda household or by children shall be la-beled so that all items of informationrequired by the Act appear upon the ar-ticle itself. In instances where this isimpracticable (for example, because ofthe size or nature of the article), therequired cautionary labeling must bedisplayed by means of a tag or othersuitable material that is no less thanfive square inches in area and is se-curely affixed to the article so that thelabeling will remain attached through-out conditions of merchandising anddistribution to the ultimate consumer.The placement and conspicuousness ofall cautionary labeling appearing onsuch a tag or material, or on anunpackaged article, shall conform tothe provisions of paragraphs (b), (c),and (d) of this section. For the pur-poses of determining the proper typesize to use on a tag or other material,the area of one side of the tag or other


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16 CFR Ch. II (1–1–97 Edition)§ 1500.122

material shall be the area of the prin-cipal display panel.

(g) Exemptions. All requirements ofthe Act are satisfied by compliancewith this § 1500.121. However, exemp-tions can be granted under section 3(c)of the Act and § 1500.83, or under theprovisions of another statute shouldthis section be incorporated in regula-tions under another statute. Section1500.82 contains the requirements forexemption requests under the FederalHazardous Substances Act.

(h) Effective date. The provisions ofthis rule apply to hazardous substancesbearing labels printed after December30, 1985. Labels printed prior to the ef-fective date of this rule may be applieduntil not later than December 28, 1987.This rule applies to all hazardous sub-stances to which labels are appliedafter December 28, 1987.

[49 FR 50383, Dec. 28, 1984]

§ 1500.122 Deceptive use of disclaim-ers.

A hazardous substance shall not bedeemed to have met the requirementsof section 2(p) (1) and (2) of the act (re-peated in § 1500.3(b)(14) (i) and (ii)) ifthere appears in or on the label (or inany accompanying literature; words,statements, designs, or other graphicmaterial that in any manner negatesor disclaims any of the label state-ments required by the act; for example,the statement ‘‘Harmless’’ or ‘‘Safearound pets’’ on a toxic or irritant sub-stance.

§ 1500.123 Condensation of label infor-mation.

Whenever the statement of the prin-cipal hazard or hazards itself providesthe precautionary measures to be fol-lowed or avoided, a clear statement ofthe principal hazard will satisfy the re-quirements of section 2(p)(1) (E) and(F) of the act (repeated in§ 1500.3(b)(14)(i) (E) and (F)). When thestatement of precautionary measuresin effect provides instruction for first-aid treatment, the statement of theprecautionary measures will satisfythe requirements of section 2(p)(1) (F)and (G) of the act (repeated in§ 1500.3(b)(14)(i) (F) and (G)).

§ 1500.125 Labeling requirements foraccompanying literature.

When any accompanying literatureincludes or bears any directions for use(by printed word, picture, design, orcombination thereof), such placard,pamphlet, booklet, book, sign, or othergraphic or visual device shall bear allthe information required by section2(p) of the act (repeated in§ 1500.3(b)(14)).

§ 1500.126 Substances determined tobe ‘‘special hazards.’’

Whenever the Commission deter-mines that for a particular hazardoussubstance intended or packaged in aform suitable for use in the householdor by children, the requirements of sec-tion 2(p) of the act (repeated in§ 1500.3(b)(14)) are not adequate for theprotection of the public health andsafety because of some special hazard,the Commission, by an appropriateorder in the FEDERAL REGISTER, shallspecify such reasonable variations oradditional label requirements that itfinds are necessary for the protectionof the public health and safety. Suchorder shall specify a date that is notless than 90 days after the order is pub-lished (unless emergency conditionsstated in the order specify an earlierdate) after which any such hazardoussubstance intended, or packaged in aform suitable, for use in the householdor by children that fails to bear a labelin accordance with such order shall bedeemed to be a misbranded hazardoussubstance.

§ 1500.127 Substances with multiplehazards.

(a) Any article that presents morethan one type of hazard (for example, ifthe article is both toxic and flam-mable) must be labeled with: An af-firmative statement of each such haz-ard; the precautionary measures de-scribing the action to be followed oravoided for each such hazard; instruc-tions, when necessary or appropriate,for first-aid treatment of persons suf-fering from the ill effects that may re-sult from each such hazard; instruc-tions for handling and storage of arti-cles that require special care in han-dling and storage because of more than


453


one type of hazard presented by the ar-ticle; and the common or usual name(or the chemical name if there is nocommon or usual name) for each haz-ardous component present in the arti-cle.

(b) Label information referring to thepossibility of one hazard may be com-bined with parallel information con-cerning any additional hazards pre-sented by the article if the resultingcondensed statement contains all ofthe information needed for dealingwith each type of hazard presented bythe article.

[38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov.1, 1973]

§ 1500.128 Label comment.The Commission will offer informal

comment on any proposed label and ac-companying literature involving a haz-ardous substance if furnished with:

(a) Complete labeling or proposed la-beling, which may be in draft form.

(b) Complete quantitative formula.(c) Adequate clinical pharma-

cological, toxicological, physical, andchemical data applicable to the pos-sible hazard of the substance.

(d) Any other information availablethat would facilitate preparation of asuitable label, such as complaints ofinjuries resulting from the product’suse or other evidence that would fur-nish human-experience data.

§ 1500.129 Substances named in theFederal Caustic Poison Act.

The Commission finds that for thosesubstances covered by the FederalCaustic Poison Act (44 Stat. 1406), therequirements of section 2(p)(1) of theFederal Hazardous Substances Act (re-peated in § 1500.3(b)(14)(i)) are not ade-quate for the protection of the publichealth. Labeling for those substances,in the concentrations listed in the Fed-eral Caustic Poison Act, were requiredto bear the signal word ‘‘poison.’’ TheCommission concludes that the lack ofthe designation ‘‘poison’’ would indi-cate to the consumer a lesser hazardand that such would not be in the in-terest of the public health. Under theauthority granted in section 3(b) of theact, the Commission therefore findsthat for the following substances, andat the following concentrations, the

word ‘‘poison’’ is necessary instead ofany signal word:

(a) Hydrochloric acid and any prepa-ration containing free or chemicallyunneutralized hydrochloric acid (HCl)in a concentration of 10 percent ormore.

(b) Sulfuric acid and any preparationcontaining free or chemicallyunneutralized sulfuric acid (H2SO4) in aconcentration of 10 percent or more.

(c) Nitric acid or any preparationcontaining free or chemicallyunneutralized nitric acid (HNO3) in aconcentration of 5 percent or more.

(d) Carbolic acid (C6H5OH), alsoknown as phenol, and any preparationcontaining carbolic acid in a con-centration of 5 percent or more.

(e) Oxalic acid and any preparationcontaining free or chemicallyunneutralized oxalic acid (H2C2O4) in aconcentration of 10 percent or more.

(f) Any salt of oxalic acid and anypreparation containing any such salt ina concentration of 10 percent or more.

(g) Acetic acid or any preparationcontaining free or chemicallyunneutralized acetic acid (HC2H2O2) ina concentration of 20 percent or more.

(h) Hypochlorous acid, either free orcombined, and any preparation con-taining the same in a concentrationthat will yield 10 percent or more byweight of available chlorine.

(i) Potassium hydroxide and anypreparation containing free or chemi-cally unneutralized potassium hydrox-ide (KOH), including caustic potash andvienna paste (vienna caustic), in a con-centration of 10 percent or more.

(j) Sodium hydroxide and any prepa-ration containing free or chemicallyunneutralized sodium hydroxide(NaOH), including caustic soda and lyein a concentration of 10 percent ormore.

(k) Silver nitrate, sometimes knownas lunar caustic, and any preparationcontaining silver nitrate (AgNO3) in aconcentration of 5 percent or more.

(l) Ammonia water and any prepara-tion containing free or chemicallyuncombined ammonia (NH3), includingammonium hydroxide and ‘‘harts-horn,’’ in a concentration of 5 percentor more.


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16 CFR Ch. II (1–1–97 Edition)§ 1500.130

§ 1500.130 Self-pressurized containers:labeling.

(a) Self-pressurized containers thatfail to bear a warning statement ade-quate for the protection of the publichealth and safety may be misbrandedunder the act, except as otherwise pro-vided pursuant to section 3 of the act.

(b) The following warning statementwill be considered as meeting the re-quirements of section 2(p)(1) of the act(repeated in § 1500.3(b)(14)(i)) if the onlyhazard associated with an article isthat the contents are under pressure:

WARNING—CONTENTS UNDER PRESSURE

Do not puncture or incinerate container.Do not expose to heat or store at tempera-tures above 120 °F. Keep out of the reach ofchildren.

The word ‘‘CAUTION’’ may be sub-stituted for the word ‘‘WARNING’’. Apractical equivalent may be sub-stituted for the statement ‘‘Keep out ofthe reach of children.’’

(c) That portion of the warning state-ment set forth in paragraph (b) of thissection in capital letters should beprinted on the main (front) panel of thecontainer in capital letters of the typesize specified in § 1500.121(c). The bal-ance of the cautionary statements mayappear together on another panel if thefront panel also bears a statement suchas ‘‘Read carefully other cautions onlllll panel.’’

(d) If an article has additional haz-ards, such as skin or eye irritancy, tox-icity, or flammability, appropriate ad-ditional front and rear panel pre-cautionary labeling is required.

§ 1500.133 Extremely flammable con-tact adhesives; labeling.

(a) Extremely flammable contact ad-hesives, also known as contact bondingcements, when distributed in contain-ers intended or suitable for householduse may be misbranded under the act ifthe containers fail to bear a warningstatement adequate for the protectionof the public health and safety.

(b) The following warning statementis considered as the minimum caution-ary labeling adequate to meet the re-quirements of section 2(p)(1) of the act(repeated in § 1500.3(b)(14)(i)) with re-spect to containers of more than one-half pint of contact adhesive and simi-

lar liquid or semiliquid articles havinga flashpoint at or below 20 °F. as deter-mined by the method in § 1500.43, whenthe only hazard foreseeable is thatcaused by the extreme flammability ofthe mixture:

DANGER

EXTREMELY FLAMMABLE

VAPORS MAY CAUSE FLASH FIRE

Vapors may ignite explosively.Prevent buildup of vapors—open all win-

dows and doors—use only with cross-ventila-tion.

Keep away from heat, sparks, and openflame.

Do not smoke, extinguish all flames andpilot lights, and turn off stoves, heaters,electric motors, and other sources of ignitionduring use and until all vapors are gone.

Close container after use.Keep out of the reach of children.

(c) The words that are in capital let-ters in the warning statement set forthin paragraph (b) of this section shouldbe printed on the main (front) panel orpanels of the container in capital let-ters of the type size specified in§ 1500.121(c). The balance of the caution-ary information may appear togetheron another panel provided the frontpanel bears a statement such as ‘‘Readcarefully other cautions on lllpanel,’’ the blank being filled in withthe identification of the specific labelpanel bearing the balance of the cau-tionary labeling. It is recommendedthat a borderline be used in conjunc-tion with the cautionary labeling.

(d) If an article has additional haz-ards, or contains ingredients listed in§ 1500.14 as requiring special labeling,appropriate additional front and rearpanel precautionary labeling is re-quired.

(e) Since the Commission has issueda regulation banning under theConsumer Product Safety Act ex-tremely flammable contact adhesivescovered by this labeling regulation(sec. 16 CFR part 1302), paragraphs (a),(b), (c) and (d) of this section are re-voked as to the subject products afterJune 13, 1978.

[38 FR 27012, Sept. 27, 1973, as amended at 42FR 63742, Dec. 19, 1977]


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§ 1500.134 Policy on first aid labelingfor saline emesis.

(a) This section states the ConsumerProduct Safety Commission’s policyconcerning first aid instructions forthe use of a salt solution to inducevomiting (saline emesis) in the event ofingestion of hazardous substances.

(b) In many cases where hazardoussubstances are ingested, the rec-ommended first aid instructions for in-ducing vomiting have contained astatement that this should be accom-plished by drinking a solution of salt(sodium chloride) in warm water. Atone time, this direction was consideredmedically acceptable. However, theCommission has obtained informationshowing that the instruction to per-form saline emesis is no longer appro-priate. This is because the use of saltto induce vomiting can cause severehypernatremia (salt poisoning) withpotentially toxic effects, particularlyin children 5 years old or younger, theage group most often involved in acci-dental poisonings. In view of the avail-ability of safer and more effectiveemetics such as ipecac syrup, the Com-mission no longer recommends a direc-tion to perform saline emesis as a firstaid direction for inducing vomiting.

(c) The Commission believes that, forproducts for which directions for salineemesis have been given in the past, ipe-cac syrup, U.S.P., is the most appro-priate emetic, unless a particular con-traindication exists in connection withany particular hazardous substance.

(d) The Commission wishes to empha-size that this policy does not requirethat any specific first aid instructionor wording be used. Where appropriate,the label may include directions (1)that the victim immediately contact adoctor or poison control center and/or(2) that vomiting be induced usingmethods other than salt. It is, ofcourse, the manufacturer’s responsibil-ity to insure that the label providesenough information in addition to firstaid instructions to fulfill all other la-beling required by statute or regula-tion.

(Sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a)))

[43 FR 33704, Aug. 1, 1978]

§ 1500.135 Summary of guidelines fordetermining chronic toxicity.

A substance may be toxic due to arisk of a chronic hazard. (A regulatorydefinition of ‘‘toxic’’ that pertains tochronic toxicity may be found at 16CFR 1500.3(c)(2).) The following discus-sions are intended to help clarify thecomplex issues involved in assessingrisk from substances that may poten-tially cause chronic hazards and, wherepossible, to describe conditions underwhich substances should be consideredtoxic due to a risk of the specifiedchronic hazards. The guidelines are notintended to be a static classificationsystem, but should be considered alongwith available data and with expertjudgment. They are not mandatory.Rather, the guidelines are intended asan aid to manufacturers in determiningwhether a product subject to the FHSApresents a chronic hazard. All defaultassumptions contained in the guide-lines on hazard and risk determinationare subject to replacement when alter-natives which are supported by appro-priate data become available. The fol-lowing are brief summaries of more ex-tensive discussions contained in theguidelines. Thus, the guidelines shouldbe consulted in conjunction with thesesummaries. Copies of the guidelinesmay be obtained from the Office ofCompliance and Enforcement,Consumer Product Safety Commission,Washington, DC 20207. (In addition tothe chronic hazards discussed below, is-sues relating to the chronic hazard ofsensitization are discussed in 16 CFR1500.3(c)(5).)

(a) Carcinogenicity. Substances aretoxic by reason of their potential car-cinogenicity in humans when they areknown or probable human carcinogenicsubstances as defined below. Sub-stances that are possible human car-cinogenic substances or for which thereis no evidence of carcinogenic effectunder the following categories lacksufficient evidence to be consideredtoxic by virtue of their potential car-cinogenicity.

(1) Known Human carcinogenic Sub-stances (‘‘sufficient evidence’’ in hu-mans). Substances are toxic by reasonof their carcinogenicity when theymeet the ‘‘sufficient evidence’’ criteria


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of carcinogenicity from studies in hu-mans, which require that a causal rela-tionship between exposure to an agentand cancer be established. This cat-egory is similar to the EnvironmentalProtection Agency’s (EPA) Group A,the International Agency for Researchon Cancer’s (IARC) Group 1, or theAmerican National Standards Insti-tute’s (ANSI) Category 1. A causal rela-tionship is established if one or moreepidemiological investigations thatmeet the following criteria show an as-sociation between cancer and exposureto the agent.

(i) No identified bias that can ac-count for the observed association hasbeen found on evaluation of the evi-dence.

(ii) All possible confounding factorswhich could account for the observedassociation can be ruled out with rea-sonable confidence.

(iii) Based on statistical analysis, theassociation has been shown unlikely tobe due to chance.

(2) Probable Human Carcinogenic Sub-stances. Substances are also toxic byreason of their probable carcino-genicity when they meet the ‘‘limitedevidence’’ criteria of carcinogenicity inhumans or the ‘‘sufficient evidence’’criteria of carcinogenicity in animalsdescribed below. This category is simi-lar to EPA’s Group B, IARC’s Group 2,or ANSI’s Categories 2 and 3. Evidencederived from animal studies that hasbeen shown not to be relevant to hu-mans is not included. For example,such evidence would result when therewas an identified mechanism of actionfor a chemical that causes cancer inanimals that has been shown not toapply to the human situation. It is rea-sonable, for practical purposes, to re-gard an agent for which there is ‘‘suffi-cient’’ evidence of carcinogenicity inanimals as if it presented a carcino-genic risk to humans.

(i) ‘‘Limited evidence’’ of carcino-genicity in humans. The evidence is con-sidered limited for establishing a caus-al relationship between exposure to theagent and cancer when a causal inter-pretation is credible, but chance, bias,or other confounding factors could notbe ruled out with reasonable con-fidence.

(ii) ‘‘Sufficient evidence’’ of carcino-genicity in animals. Sufficient evidenceof carcinogenicity requires that thesubstance has been tested in well-de-signed and -conducted studies (e.g., asconducted by National Toxicology Pro-gram (NTP), or consistent with the Of-fice of Science Technology Assessmentand Policy (OSTP) guidelines) and hasbeen found to elicit a statistically sig-nificant (p <0.05) exposure-related in-crease in the incidence of malignanttumors, combined malignant and be-nign tumors, or benign tumors if thereis an indication of the ability of suchbenign tumors to progress to malig-nancy:

(A) In one or both sexes of multiplespecies, strains, or sites of independentorigin; or experiments using differentroutes of administration or dose levels;or

(B) To an unusual degree in a singleexperiment (one species/strain/sex)with regard to unusual tumor type, un-usual tumor site, or early age at onsetof the tumor.The presence of positive effects inshort-term tests, dose-response effectsdata, or structure-activity relationshipare considered additional evidence.

(3) Possible Human Carcinogenic Sub-stance (‘‘limited evidence’’ animal car-cinogen). In the absence of ‘‘sufficient’’or ‘‘limited’’ human data, agents with‘‘limited’’ evidence of carcinogenicityfrom animal studies fall into this cat-egory. Such substances, and those thatdo not fall into any other group, arenot considered ‘‘toxic.’’ This does notimply that the substances are or arenot carcinogens, only that the evidenceis too uncertain to provide for a deter-mination. This category is similar toEPA’s Group C, IARC’s Group 3, orANSI’s category 4.

(b) Neurotoxicity. Substances are toxicby reason of their potentialneurotoxicity in humans when theymeet the ‘‘sufficient evidence’’ or ‘‘lim-ited evidence’’ criteria of neurotoxicityin humans, or when they meet the‘‘sufficient evidence’’ criteria ofneurotoxicity in animals.

(1) Known Neurotoxic Substances (‘‘suf-ficient evidence in humans’’). Substancesare toxic by reason of theirneurotoxicity and are considered‘‘known neurotoxic substances’’ when


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they meet the ‘‘sufficient evidence’’criteria of neurotoxicity derived fromstudies in humans which require that acausal association between exposure toan agent and neurotoxicity be estab-lished with a reasonable degree of cer-tainty. Substances in this categorymeet the definition of ‘‘neurotoxic’’ asstated above. ‘‘Sufficient evidence,’’derived from human studies, for a caus-al association between exposure to achemical and neurotoxicity is consid-ered to exist if the studies meet the fol-lowing criteria.

(i) A consistent pattern of neuro-logical dysfunction is observed.

(ii) The adverse effects/lesions ac-count for the neurobehavioral dysfunc-tion with reasonable certainty.

(iii) All identifiable bias and con-founding factors are reasonably dis-counted after consideration.

(iv) The association has been shownunlikely to be due to chance, based onstatistical analysis.

(2) Probable Neurotoxic Substances.Substances are also toxic by reason oftheir probable neurotoxicity when theymeet the ‘‘limited evidence’’ criteria ofneurotoxicity in humans, or the ‘‘suffi-cient evidence’’ criteria derived fromanimal studies. Evidence derived fromanimal studies that has been shown notto be relevant to humans is not in-cluded. Such evidence would result, forexample, when there was an identifiedmechanism of action for a chemicalthat causes neurotoxicity in animalsthat has been shown not to apply tothe human situation.

(i) ‘‘Limited evidence’’ of neurotoxicityin humans. The evidence derived fromhuman studies is considered limited forneurotoxicity when the evidence is lessthan convincing, i.e., one of the criteriaof ‘‘sufficient evidence’’ ofneurotoxicity for establishing a causalassociation between exposure to theagent and neurotoxicity is not met,leaving some uncertainties in estab-lishing a causal association.

(ii) ‘‘Sufficient evidence’’ ofneurotoxicity in animals. Sufficient evi-dence of neurotoxicity derived fromanimal studies for a causal associationbetween exposure to a chemical andneurotoxicity requires that:

(A) The substance has been tested inwell-designed and -conducted studies

(e.g., NTP’s neurobehavioral battery,or conforming to EPA’s neurotoxicitytest guidelines); and

(B) The substance has been found toelicit a statistically significant (p<0.05) increase in any neurotoxic effectin one or both sexes of multiple spe-cies, strains, or experiments using dif-ferent routes of administration anddose-levels.

(3) Possible Neurotoxic Substances.‘‘Possible neurotoxic substances’’ arethe substances which meet the ‘‘lim-ited evidence’’ criteria of neurotoxicityevidence derived from animal studiesin the absence of human data, or in thepresence of inadequate human data, ordata which do not fall into any othergroup. Substances in this category arenot considered ‘‘toxic.’’

(c) Developmental and ReproductiveToxicity—(1) Definitions of ‘‘Sufficient’’and ‘‘Limited’’ Evidence. The followingdefinitions apply to all categories stat-ed below.

(i) ‘‘Sufficient evidence’’ from humanstudies for a causal association be-tween human exposure and the subse-quent occurrence of developmental orreproductive toxicity is considered toexist if the studies meet the followingcriteria:

(A) No identified bias that can ac-count for the observed association hasbeen found on evaluation of the evi-dence.

(B) All possible confounding factorswhich could account for the observedassociation can be ruled out with rea-sonable confidence.

(C) Based on statistical analysis, theassociation has been shown unlikely tobe due to chance.

(ii) ‘‘Limited evidence’’ from humanstudies exists when the human epide-miology meets all but one of the cri-teria for ‘‘sufficient evidence’’; i.e., thestatistical evidence is borderline as op-posed to clear-cut, there is a source ofbias, or there are confounding factorsthat have not been and cannot be ac-counted for.

(iii) ‘‘Sufficient evidence’’ from ani-mal studies exists when

(A) Obtained from a good quality ani-mal study; and

(B) The substance has been found toelicit a statistically significant (p<0.05)treatment-related increase in multiple


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endpoints in a single species/strain, orin the incidence of a single endpoint atmultiple dose levels or with multipleroutes of administration in a singlespecies/strain, or increase in the inci-dence of a single endpoint in multiplespecies/strains/ experiments.

(iv) ‘‘Limited evidence’’ from animalstudies exists when:

(A) Obtained from a good qualitystudy and there is a statistically sig-nificant (p<0.05) treatment-related in-crease in the incidence of a singleendpoint in a single species/strain/ex-periment at a single dose level admin-istered through only one route andsuch evidence otherwise does not meetthe criteria for ‘‘sufficient evidence’’;or

(B) The evidence is derived fromstudies which can be interpreted toshow positive effects but have somequalitative or quantitative limitationswith respect to experimental proce-dures (e.g., doses, exposure, follow-up,number of animals/group, reporting ofthe data, etc.) which would preventclassification of the evidence in thegroup of ‘‘sufficient evidence.’’

(2) Developmental Toxicants. Sub-stances are toxic by reason of their po-tential developmental or reproductivetoxicity when they meet the ‘‘suffi-cient evidence’’ or ‘‘limited evidence’’criteria of developmental or reproduc-tive toxicity in humans, or when theymeet the ‘‘sufficient evidence’’ criteriaof developmental or reproductive tox-icity in animals. The Food and DrugAdministration (FDA) and the Euro-pean Economic Community (EEC) havedeveloped categories for teratogens butnot other developmental toxicants. Theteratogen guidelines limit the informa-tion only to structural birth defectsand do not include other hazards of de-velopmental toxicity such asembryonal death, fetal death, or func-tional deficiencies which are also im-portant in assessing the overall tox-icity of a substance when administeredduring pregnancy. Recently, EPA hasproposed a system for classifying de-velopmental toxicity. The Occupa-tional Safety and Health Administra-tion (OSHA) has not yet developed anyclassification for developmental tox-icity. The commission has establishedthe following categories for determina-

tion of developmental toxicity accord-ing to the available evidence.

(i) Known Human Developmental Toxi-cant (‘‘sufficient evidence in humans’’). Asubstance is considered a ‘‘knownhuman developmental toxicant’’ ifthere is ‘‘sufficient’’ human evidence toestablish a causal association betweenhuman exposure and the subsequent oc-currence of developmental toxicitymanifested by death of the conceptus(embryo or fetus), or structural orfunctional birth defects. This category(Human Developmental Toxicant) iscomparable to category 1 of the EECand categories D and X of FDA, exceptthat these guidelines are limited toteratogens. This category is also com-parable to the category ‘‘definitive evi-dence for human developmental tox-icity’’ proposed by EPA.

(ii) Probable Human DevelopmentalToxicant. A substance is considered a‘‘probable human developmental toxi-cant’’ if there is ‘‘limited’’ human evi-dence or ‘‘sufficient’’ animal evidenceto establish a causal association be-tween human exposure and subsequentoccurrence of developmental toxicity.This group (Probable Human Devel-opmental Toxicant) is comparable tothe category ‘‘adequate evidence forhuman developmental toxicity’’ pro-posed by EPA. This category is alsocomparable to category 2 of the EECand category A1 of FDA, except thatthese guidelines are limited toteratogens.

(iii) Possible Human DevelopmentalToxicant. A substance is considered a‘‘possible human developmental toxi-cant’’ if there is ‘‘limited’’ animal evi-dence, in the absence of human data, orin the presence of inadequate humandata, or which does not fall into anyother group, to establish a causal asso-ciation between human exposure andsubsequent occurrence of developmen-tal toxicity. EEC, FDA, and EPA havenot developed a category comparableto this group. The Commission believesthat data from well planned animalstudies are important to consider eventhough they may provide only limitedevidence of developmental toxicity.

(3) Male Reproductive Toxicants. Malereproductive toxicants can be groupedinto the following different categories


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based on evidence obtained fromhuman or animal studies.

(i) Known Human Male ReproductiveToxicant. A substance is considered a‘‘known human male reproductive toxi-cant’’ if there is ‘‘sufficient’’ humanevidence to establish a causal associa-tion between human exposure and theadverse effects on male reproductivemain endpoints which are mating abil-ity, fertility, and prenatal and post-natal development of the conceptus.This category is comparable to the onetermed ‘‘Known Positive’’ in the EPAguidelines on male reproductive riskassessment.

(ii) Probable Human Male ReproductiveToxicant. A substance is considered a‘‘probable human male reproductivetoxicant’’ if there is ‘‘limited’’ humanevidence or ‘‘sufficient’’ animal evi-dence to establish a causal associationbetween human exposure and the ad-verse effects on male reproductivemain endpoints. This category is com-parable to the one termed ‘‘ProbablePositive’’ in the EPA guidelines onmale reproductive risk assessment.However, the EPA category is basedonly on sufficient animal evidence.CPSC believes that limited human evi-dence is also sufficient for a chemicalto be placed in this category.

(iii) Possible Human Male ReproductiveToxicant. A substance is considered a‘‘possible human male reproductivetoxicant’’ if there is limited animalevidence, in the absence of humandata, or in the presence of inadequatehuman data, or which does not fall intoany other group, to establish a causalassociation between human exposureand adverse effects on male reproduc-tive main endpoints. This category iscomparable to the one termed ‘‘Pos-sible Positive A’’ in the EPA guidelineson male reproductive risk assessment.EPA proposes to use either limitedhuman or limited animal evidence datato classify a toxicant as a ‘‘PossiblePositive A’’ toxicant. As describedabove, CPSC would elevate limitedhuman evidence to the category ‘‘Prob-able Human Male Reproductive Toxi-cant.’’

(4) Female Reproductive Toxicants. Fe-male reproductive toxicants can begrouped into the following differentcategories based on evidence obtained

from human or animal studies. EPAhas proposed guidelines for assessingfemale reproductive risk but has notyet proposed a specific system for cat-egorization of female reproductivetoxicants.

(i) Known Human Female ReproductiveToxicant. A substance is considered a‘‘known human female reproductivetoxicant’’ if there is ‘‘sufficient’’human evidence to establish a causalassociation between human exposureand adverse effects on female reproduc-tive function such as mating ability,fertility, and prenatal and postnataldevelopment of the conceptus.

(ii) Probable Human Female Reproduc-tive Toxicant. A substance is considereda ‘‘probable human female reproduc-tive toxicant’’ if there is ‘‘limited’’human evidence or ‘‘sufficient’’ animalevidence to establish a causal associa-tion between human exposure and ad-verse effects on female reproductivefunction.

(iii) Possible Human Female Reproduc-tive Toxicant. A substance is considereda ‘‘possible human female reproductivetoxicant’’ if there is ‘‘limited’’ animalevidence, in the absence of humandata, or in the presence of inadequatehuman data, or which does not fall intoany other group, to establish a causalassociation between human exposureand adverse effects on female reproduc-tive function.

(d) Other Subjects Related to the Deter-mination that a Substance is Toxic.Under the FHSA, for a toxic substanceto be considered hazardous, it must notonly have the potential to be hazardousbut there must also be the potentialthat persons are exposed to the sub-stance, that the substance can enterthe body, and that there is a signifi-cant risk of an adverse health effect as-sociated with the customary handlingand use of the substance. Under theseguidelines, existence of an adversehealth effect means that such exposureis above the ‘‘acceptable daily intake’’(‘‘ADI’’). The ADI is based on the risksposed by the substance, and whetherthey are acceptable under the FHSA.This section addresses those issues by


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providing guidelines concerning assess-ment of exposure, assessment of bio-availability, determination of accept-able risks and the ADI to children andadults, and assessment of risk.

(1) Assessment of Exposure. An expo-sure assessment may comprise a singleexposure scenario or a distribution ofexposures. Reasonably foreseeable use,as well as accidental exposure, shouldbe taken into consideration when de-signing exposure studies. The followingguidelines should be used in the assess-ment of exposure.

(i) Inhalation. Inhalation studies toassess exposure should be reliable stud-ies using direct monitoring of popu-lations, predictions of exposurethrough modeling, or surrogate data.

(A) Direct Monitoring. Populations tobe monitored should be selected ran-domly to be representative of the gen-eral population, unless the exposure ofa particular subset population is thedesired goal of the assessment. Themonitoring technique should be appro-priate for the health effect of interest.

(B) Modeling. Predictions of exposureto a chemical using mathematicalmodels can be based on physical andchemical principles, such as mass bal-ance principles. Mass balance modelsshould consider the source strength ofthe product of interest, housing char-acteristics, and ambient conditionslikely to be encountered by the studiedpopulation.

(C) Surrogate Data. Surrogate datashould only be used when data concern-ing the chemical of interest are sparseor unavailable and when there is a rea-sonable assurance that the surrogatedata will accurately represent thechemical of interest.

(ii) Oral Ingestion. Oral ingestionstudies may involve direct monitoringof sources of chemicals as well as lab-oratory simulations. The estimation ofexposure from ingestion of chemicalspresent in consumer products is pre-dicted based upon estimates of use ofthe product and absorption of thechemical from the gastrointestinaltract. The following criteria should beestablished for laboratory simulationsto estimate exposure:

(A) A simulant or range of simulantsshould be carefully selected to mimicthe possible range of conditions which

occur in humans, such as full andempty stomachs, or various salivacompositions at different times of theday.

(B) The mechanical action to which aproduct is submitted must be chosen torepresent some range of realistic condi-tions to which a human may subjectthe product.

(iii) Dermal Exposure. (A) Dermal ex-posure involves estimating the amountof substance contacting the skin. Thismay involve experiments measuringthe amount of material leached from aproduct contacting a liquid layer whichinterfaces with the skin, or the amountof substance which migrates from aproduct (in solid or liquid form) whichis in contact with the skin.

(B) Parameters to be considered in-clude: Surface area of the skin con-tacted, duration of contact, frequencyof contact, and thickness of a liquidinterfacial layer.

(2) Assessment of Bioavailability. (i)The need to consider bioavailability inestimating the risk from use of a prod-uct containing a toxic substance onlyarises when it is anticipated that theabsorption characteristics of a sub-stance to which there is human expo-sure will differ from those characteris-tics for the substance tested in thestudies used to define the dose-responserelationship.

(ii) In determining the need to assessbioavailability, the factors to be exam-ined include:

(A) The physical or chemical form ofthe substance,

(B) The route of exposure (inhalation,ingestion, or through the skin),

(C) The presence of other constitu-ents in the product which interferewith or alter absorption of the toxicsubstance, and

(D) Dose.(3) Assessment of Risk. This section on

quantitative risk assessment applies toestimates of risk for substances thatare toxic by reason of their carcino-genicity.

(i) Generally, the study leading tothe highest risk should be used in therisk assessment; however, other factorsmay influence the choice of study.

(ii) Risk should be based on the maxi-mum likelihood estimate from a multi-stage model (such as Global83 or later


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version) unless the maximum likeli-hood estimate is not linear at low dose,in which case the 95% upper confidencelimit on risk should be used.

(iii) For systemic carcinogens, if esti-mates of human risk are made based onanimal data, a factor derived from di-viding the assumed human weight (70kg) by the average animal weight dur-ing the study and taking that to the 1⁄3power should be used. There is the pos-sibility that this factor may bechanged, using the 1⁄4 power instead ofthe 1⁄3 power, as part of a unified Fed-eral regulatory approach. If such an ap-proach is adopted, it will apply here.

(iv) When dose is expressed as partsper million, and the carcinogen acts atthe site of contact, humans and ani-mals exposed to the same amount forthe same proportion of lifetime shouldbe assumed to be equally sensitive.

(v) If no experimental study havingthe same route of exposure as that an-ticipated for human use of a substanceis available, a study by another routeof exposure may be used.Pharmacokinetic methods may be usedif sufficient data are available.

(vi) When exposure scenarios are dif-ferent from those used in the underly-ing study upon which estimates of riskare based, proportionality should beapplied. If pharmacokinetic methodsare used to adjust for risks at high ver-sus low exposure levels, level-timemeasures should not be combined with-out taking the non-linearity into ac-count.

(4) Acceptable Risks—(i) ADI for Car-cinogens. The maximum acceptabledaily intake (‘‘ADI’’) is that exposureof a toxic (by virtue of its carcino-genicity) substance that is estimatedto lead to a lifetime excess risk of onein a million. Exposure refers to the an-ticipated exposure from normal life-time use of the product, including useas a child as well as use as an adult.

(ii) ADI for Neurotoxicological and De-velopmental/Reproductive Agents. Due tothe difficulties in using a numericalrisk assessment method to determinerisk for neurotoxicological or devel-opmental/reproductive toxicants, theCommission is using a safety factor ap-proach, as explained below.

(A) Human Data. If the hazard isascertained from human data, a safety

factor of ten will be applied to the low-est No Observed Effect Level (‘‘NOEL’’)seen among the relevant studies. If noNOEL can be determined, a safety fac-tor of 100 will be applied to the LowestObserved Effect Level (‘‘LOEL’’). Boththe NOEL and LOEL are defined interms of daily dose level.

(B) Animal Data. If the hazard isascertained from animal data, a safetyfactor of one hundred will be applied tothe lowest NOEL. If no NOEL can bedetermined, a safety factor of onethousand will be applied to the lowestLOEL. Both the NOEL and LOEL aredefined in terms of daily dose level.

[57 FR 46665, Oct. 9, 1992]

§ 1500.210 Responsibility.The provisions of these regulations

(16 CFR subchapter C of chapter II)with respect to the doing of any actshall be applicable also to the causingof such act to be done.

§ 1500.211 Guaranty.In the case of the giving of a guar-

anty or undertaking referred to in sec-tion 5(b)(2) of the act, each person sign-ing such guaranty or undertaking, orcausing it to be signed, shall be consid-ered to have given it. Each personcausing a guaranty or undertaking tobe false is chargeable with violations ofsection 4(d) of the act.

§ 1500.212 Definition of guaranty; sug-gested forms.

(a) A guaranty or undertaking re-ferred to in section 5(b)(2) of the actmay be:

(1) Limited to a specific shipment orother delivery of an article, in whichcase it may be a part of or attached tothe invoice or bill of sale covering suchshipment of delivery; or

(2) General and continuing, in whichcase, in its application to any shipmentor other delivery of an article, it shallbe considered to have been given at thedate such article was shipped or deliv-ered, or caused to be shipped or deliv-ered, by the person who gives the guar-anty of undertaking.

(b) The following are suggested formsof guaranty or undertaking referred toin section 5(b)(2) of the act.

(1) Limited form for use on invoice orbill of sale.


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(Name of person giving the guaranty or un-dertaking)

hereby guarantees that no article listedherein is misbranded within the meaning ofthe Federal Hazardous Substances Act.

(Signature and post-office address of persongiving the guaranty or undertaking)

(2) General and continuing forms.

The article comprising each shipment orother delivery hereafter made by lllll

(Name of person giving the guaranty or un-dertaking)

to, or on the order of llllllllll

(Name and post-office address of person towhom the guaranty or undertaking isgiven)

is hereby guaranteed, as of the date of suchshipment or delivery, to be, on such date,not misbranded within the meaning of theFederal Hazardous Substances Act.

(Signature and post-office address of persongiving the guaranty or undertaking)

(c) The application of a guaranty orundertaking referred to in section5(b)(2) of the act to any shipment orother delivery of an article shall expirewhen such article, after shipment ordelivery by the person who gave suchguaranty or undertaking, becomes mis-branded within the meaning of the act.

§ 1500.213 Presentation of views undersection 7 of the act.

(a) Presentation of views under sec-tion 7 of the act shall be private and in-formal. The views presented shall beconfined to matters relevant to thecontemplated proceeding. Such viewsmay be presented by letter or in personby the person to whom the notice wasgiven, or by his representative. In casesuch person holds a guaranty or under-taking referred to in section 5(b)(2) ofthe act applicable to the article onwhich such notice was based, suchguaranty or undertaking, or a verifiedcopy thereof, shall be made a part ofsuch presentation of views.

(b) Upon request, reasonably made,by the person to whom a notice ap-pointing a time and place for the pres-entation of views under section 7 of theact has been given, or by his represent-ative, such time or place, or both suchtime and place, may be changed if the

request states reasonable groundstherefor. Such request shall be ad-dressed to the office of the ConsumerProduct Safety Commission that issuedthe notice.

§ 1500.214 Examinations and investiga-tions; samples.

When any officer or employee of theCommission collects a sample of a haz-ardous substance for analysis under theact, the sample shall be designated asan official sample if records or otherevidence is obtained by him or anyother officer or employee of the Com-mission indicating that the shipmentor other lot of the article from whichsuch sample was collected was intro-duced or delivered for introduction intointerstate commerce, or was in or wasreceived in interstate commerce, orwas manufactured within a Territorynot organized with a legislative body.Only samples so designated by an offi-cer or employee of the Commissionshall be considered to be official sam-ples:

(a) For the purpose of determiningwhether or not a sample is collected foranalysis, the term ‘‘analysis’’ includesexaminations and tests.

(b) The owner of a hazardous sub-stance of which an official sample iscollected is the person who owns theshipment or other lot of the articlefrom which the sample is collected.

IMPORTS

§ 1500.265 Imports; definitions.

For the purposes of the regulationsprescribed under section 14 of the act:

(a) The term ‘‘owner or consignee’’means the person who has the rights ofa consignee under the provisions of theTariff Act of 1930 (secs. 483, 484, 485, 46Stat. 721 as amended; 19 U.S.C. 1483,1484, 1485).

(b) The term ‘‘area office director’’means the director of the area office ofthe Consumer Product Safety Commis-sion having jurisdiction over the portof entry through which a hazardoussubstance is imported or offered for im-port, or such officer of the area officeas he may designate to act in his behalfin administering and enforcing the pro-visions of section 14 of the act.


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§ 1500.266 Notice of sampling.When a sample of a hazardous sub-

stance offered for import has been re-quested by the director of the area of-fice, the collector of customs havingjurisdiction over the hazardous sub-stance shall give to the owner or con-signee prompt notice of delivery of, orintention to deliver, such sample. Uponreceipt of the notice, the owner or con-signee shall hold such hazardous sub-stance and not distribute it until fur-ther notice from the area office direc-tor or the collector of customs of theresults of examination of the sample.

§ 1500.267 Payment for samples.The Consumer Product Safety Com-

mission will pay for all import samplesthat are found to be in compliance withthe requirements of the act. Billing forreimbursement should be made by theowner or consignee to the Commissionarea office headquarters in the terri-tory of which the shipment was offeredfor import. Payment for samples willnot be made if the hazardous substanceis found to be in violation of the act,even though subsequently brought intocompliance under the terms of an au-thorization to bring the article intocompliance.

§ 1500.268 Hearing.(a) If it appears that the hazardous

substance may be subject to refusal ofadmission, the area office directorshall give the owner or consignee awritten notice to that effect, statingthe reasons therefor. The notice shallspecify a place and a period of timeduring which the owner or consigneeshall have an opportunity to introducetestimony. Upon timely request, givingreasonable grounds therefor, such timeand place may be changed. Such testi-mony shall be confined to matters rel-evant to the admissibility of the haz-ardous substance, and may be intro-duced orally or in writing.

(b) If such owner or consignee sub-mits or indicates his intention to sub-mit an application for authorization torelabel or perform other action tobring the hazardous substance intocompliance with the act, such testi-mony shall include evidence in supportof such application. If such applicationis not submitted at or prior to the

hearing, the area office director shallspecify a time limit, reasonable in thelight of the circumstances, for filingsuch application.

§ 1500.269 Application for authoriza-tion.

Application for authorization torelabel or perform other action tobring the hazardous substance intocompliance with the act may be filedonly by the owner or consignee andshall:

(a) Contain detailed proposals forbringing the article into compliancewith the act.

(b) Specify the time and place wheresuch operations will be carried out andthe approximate time for their comple-tion.

§ 1500.270 Granting of authorization.

(a) When authorization contemplatedby § 1500.269 is granted, the area officedirector shall notify the applicant inwriting, specifying:

(1) The procedure to be followed:(2) That the operations are to be car-

ried out under the supervision of an of-ficer of the Consumer Product SafetyCommission or the Bureau of Customs,as the case may be;

(3) A time limit, reasonable in thelight of the circumstances, for comple-tion of the operations; and

(4) Such other conditions as are nec-essary to maintain adequate super-vision and control over the article.

(b) Upon receipt of a written requestfor extension of time to complete suchoperations, containing reasonablegrounds therefor, the area office direc-tor may grant such additional time ashe deems necessary.

(c) An authorization may be amendedupon a showing of reasonable groundstherefor and the filing of an amendedapplication for authorization with thearea office director.

(d) If ownership of a hazardous sub-stance covered by an authorizationchanges before the operations specifiedin the authorization have been com-pleted, the original owner will be heldresponsible, unless the new owner hasexecuted a bond and obtained a new au-thorization. Any authorization grantedunder this section shall supersede and


464

16 CFR Ch. II (1–1–97 Edition)§ 1500.271

nullify any previously granted author-ization with respect to the article.

§ 1500.271 Bonds.(a) The bonds required under section

14(b) of the act may be executed by theowner or consignee on the appropriateform of a customs single-entry or termbond, containing a condition for the re-delivery of the merchandise or any partthereof upon demand of the collector ofcustoms and containing a provision forthe performance of conditions as maylegally be imposed for the relabeling orother action necessary to bring thehazardous substance into compliancewith the act in such manner as is pre-scribed for such bond in the customsregulations in force on the date of re-quest for authorization. The bond shallbe filed with the collector of customs.

(b) The collector of customs may can-cel the liability for liquidated damagesincurred under the above-mentionedprovisions of such a bond, if he receivesan application for relief therefrom,upon the payment of a lesser amountor upon such other terms and condi-tions as shall be deemed appropriateunder the law and in view of the cir-cumstances, but the collector shall notact under this regulation in any caseunless the area office director is in fullagreement with the action.

§ 1500.272 Costs chargeable in connec-tion with relabeling and recondi-tioning inadmissible imports.

The cost of supervising the relabelingor other action necessary in connectionwith an import of a hazardous sub-stance that fails to comply with theact shall be paid by the owner or con-signee who files an application request-ing such action and executes a bond,pursuant to section 14(b) of the act.The cost of such supervision shall in-clude, but not be restricted to, the fol-lowing:

(a) Travel expenses of the supervisingofficer.

(b) Per diem in lieu of subsistence ofthe supervising officer when away fromhis home station as provided by law.

(c) Services of the supervising officer,to be calculated at the rate of a GS 11,step 1 employee, except that such serv-ices performed by a customs officer andsubject to the provisions of the Act of

February 13, 1911, as amended (sec. 5, 36Stat. 901 as amended; 19 U.S.C. 267),shall be calculated as provided in thatAct.

(d) Services of the analyst, to be cal-culated at the rate of a GS 12, step 1employee (which shall include the useof the chemical laboratories and equip-ment of the Consumer Product SafetyCommission).

(e) The minimum charge for servicesof supervising officers and of analystsshall be not less than the charge for 1hour, and time after the first hourshall be computed in multiples of 1hour, disregarding fractional parts lessthan one-half hour.

[38 FR 27012, Sept. 27, 1973, as amended at 57FR 28605, June 26, 1992]

PART 1501—METHOD FOR IDENTI-FYING TOYS AND OTHER ARTI-CLES INTENDED FOR USE BYCHILDREN UNDER 3 YEARS OFAGE WHICH PRESENT CHOKING,ASPIRATION, OR INGESTIONHAZARDS BECAUSE OF SMALLPARTS

Sec.1501.1 Purpose.1501.2 Scope.1501.3 Exemptions.1501.4 Size requirements and test procedure.1501.5 Enforcement procedure.

AUTHORITY: Secs. 2(f)(1)(D), (q)(1)(A), (s),3(e)(1), and 10; 74 Stat. 372, 374, 375 as amend-ed; 80 Stat. 1304–05, 83 Stat. 187–89 (15 U.S.C.1261, 1262, 1269).

SOURCE: 44 FR 34903, June 15, 1979, unlessotherwise noted.

§ 1501.1 Purpose.

Section 1500.18(a)(9) of this chapterclassifies as a banned hazardous sub-stance any toy or other article in-tended for use by children under 3years of age that presents a choking,aspiration, or ingestion hazard becauseof small parts. This part 1501 describescertain articles that are subject to§ 1500.18(a)(9); lists certain articles thatare specifically exempted; and providesa test method for determining whetheran article is hazardous to childrenunder 3 because it, or one of its compo-nents that can be detached or broken
